Remote Diagnostic Technologies TEMPUSIC-2 Quadband GSM/GPRS Module User Manual Tempus IC Host User Operator Manual

Remote Diagnostic Technologies Ltd. Quadband GSM/GPRS Module Tempus IC Host User Operator Manual

Tempus IC Host User-Operator Manual

Tempus IC User/Operator Manual USA Part number 41-1025 Copyright  2012, Remote Diagnostics Technologies Ltd. UK Date of Issue: 27th November 2012
Tempus IC User/Operator Manual- USA Page I 41-1025-03A Contents 1 INTRODUCTION ................................................................................................................ 5 1.1 Manufacturer's Address .......................................................................................... 5 1.2 CE Statement ......................................................................................................... 5 1.3 FDA Prescription Statement ................................................................................... 5 1.4 Proprietary Notice ................................................................................................... 5 1.5 Use of This Manual................................................................................................. 6 1.6 Patent Claims ......................................................................................................... 6 1.7 Limited Warranty .................................................................................................... 6 1.7.1 Service Support and Returns ......................................................................................................... 6 2 WARNINGS AND CAUTIONS ........................................................................................... 7 2.1 EMC Statement ...................................................................................................... 7 2.2 Indications for Use .................................................................................................. 7 2.3 Contraindications .................................................................................................... 7 2.4 Warnings, Cautions and Notes ............................................................................... 8 2.4.1 Tempus IC Warnings, Cautions and Notes ................................................................................... 8 2.4.2 LoFlo Sidestream Capnometer - Warnings, Cautions, & Notes .................................................. 15 2.4.3 Pulse Oximeter Sensor - Warnings, Cautions, & Notes .............................................................. 16 2.4.4 ECG Recorder Sensor - Warnings, Cautions, & Notes ............................................................... 17 2.4.5 The Blood Pressure Monitor - Warnings, Cautions, & Adverse Reactions ................................. 17 3 INTRODUCTION TO THE TEMPUS IC .............................................................................19 3.1 Product Description and List of Features .............................................................. 19 4 INTRODUCTION TO THE TEMPUS IC .............................................................................20 4.1 Tempus IC Device ................................................................................................ 20 4.1.1 Tempus IC Front .......................................................................................................................... 20 4.1.2 Tempus IC Base .......................................................................................................................... 21 4.1.3 Tempus IC Rear........................................................................................................................... 21 4.1.4 Tempus IC Sides ......................................................................................................................... 21 5 USING THE TEMPUS IC ...................................................................................................23 5.1 Controlling the Tempus IC .................................................................................... 23 5.2 Explanation of the Tempus IC Screen .................................................................. 27 5.2.1 Status Bar – Clock (Time Stamp) ................................................................................................ 27 5.2.2 Status Bar – Bluetooth® Indicator ................................................................................................ 27 5.2.3 Status Bar - WiFi Indicator ........................................................................................................... 28 5.2.4 Status Bar – GSM/GPRS Indicator .............................................................................................. 28 5.2.5 Instrument Readings .................................................................................................................... 28 5.2.6 Instrument Status Indicators ........................................................................................................ 29 5.3 Device Sensors .................................................................................................... 29 5.3.1 Pulse Rate and Oxygen Saturation (SpO2) ................................................................................. 29 5.3.2 Blood Pressure ............................................................................................................................ 29 5.3.3 Electrocardiograph (ECG) ........................................................................................................... 29 5.3.4 End Tidal CO2 (ETCO2) and Respiration Rate ........................................................................... 30 5.3.5 Temperature ................................................................................................................................ 30 5.3.6 Blood Glucose level ..................................................................................................................... 30 5.4 Digital Camera ...................................................................................................... 30 5.5 Voice and Data Communications ......................................................................... 31
Tempus IC User/Operator Manual- USA Page II 41-1025-03A 6 SETTING UP .....................................................................................................................32 6.1.1 Unpacking the Tempus IC ........................................................................................................... 32 6.2 Tempus IC Bag .................................................................................................... 32 6.3 Switching On ........................................................................................................ 34 6.3.1 Immediately after Switching On ................................................................................................... 34 7 ESTABLISHING COMMUNICATION WITH THE RESPONSE CENTRE .........................36 7.1 Making the Phone Connection ............................................................................. 36 7.2 Fitting the Headset and Making the Voice Connection ......................................... 37 7.2.1 Using the Bluetrek Wireless Headset .......................................................................................... 37 7.2.2 Using the Sennheiser VMX 200 Wireless Headset ..................................................................... 42 7.3 Connection Status Indicators ................................................................................ 47 7.3.1 Dialling Order and Indicators When Dialling ................................................................................ 48 7.4 Communications Modes ....................................................................................... 49 7.4.1 Changing Modes .......................................................................................................................... 49 7.4.2 Using Available Modes ................................................................................................................ 49 7.4.3 Changing the Connection Mode .................................................................................................. 50 8 TAKING MEDICAL READINGS ........................................................................................52 8.1 Blood Pressure and Pulse Oximeter..................................................................... 52 8.1.1 Understanding the Pulse Oximeter Results ................................................................................. 54 8.1.2 Understanding the Blood Pressure Results ................................................................................. 54 8.1.3 Blood Pressure Monitor Error iAssist Help Process .................................................................... 55 8.2 Electrocardiograph (ECG) .................................................................................... 55 8.2.1 Monitoring an ECG ...................................................................................................................... 57 8.2.2 Recording an ECG ....................................................................................................................... 58 8.3 Capnometer .......................................................................................................... 59 8.3.1 Understanding the Capnometer Results ..................................................................................... 60 8.4 Thermometer ........................................................................................................ 61 8.4.1 Using the Thermometer ............................................................................................................... 63 8.4.2 Understanding the Thermometer Results .................................................................................... 63 8.5 Glucometer ........................................................................................................... 64 8.5.1 MyGlucoHealth Glucometer ......................................................................................................... 64 8.6 Digital Camera ...................................................................................................... 68 8.6.1 Annotation of Digital pictures ....................................................................................................... 71 8.7 Interacting with the Response Centre ................................................................... 71 8.7.1 The Response Centre .................................................................................................................. 71 8.7.2 Remote Viewing and Control ....................................................................................................... 72 8.8 Recording Data Off-line and Transmitting On-line ................................................ 72 8.9 GPS Location ....................................................................................................... 73 8.10 Actions after Use – Turning the Tempus IC Off .................................................... 74 8.10.1 Logging Maintenance Requirements....................................................................................... 75 9 AFTER USING THE TEMPUS IC ......................................................................................77 9.1 Cleaning the Tempus IC ....................................................................................... 77 9.1.1 Cleaning the Thermometer .......................................................................................................... 77 9.1.2 Cleaning the Glucometer ............................................................................................................. 77 9.2 Cleaning and Re-packing Help Screen ................................................................. 77 9.3 Single-Use Devices .............................................................................................. 79 10 MAINTENANCE, SERVICING AND TROUBLESHOOTING ............................................80 10.1 General ................................................................................................................. 80 10.2 Battery Management ............................................................................................ 80
Tempus IC User/Operator Manual- USA Page III 41-1025-03A 10.2.1 The Battery .............................................................................................................................. 80 10.2.2 Removing the Battery from the Tempus IC ............................................................................. 83 10.2.3 Charging the Battery................................................................................................................ 84 10.2.4 Tempus IC Battery Shelf Life .................................................................................................. 86 10.2.5 Other Tempus IC Batteries ...................................................................................................... 86 10.2.6 Disposal of Batteries................................................................................................................ 89 10.3 Troubleshooting .................................................................................................... 90 10.3.1 Errors ....................................................................................................................................... 90 10.3.2 Thermometer Errors ................................................................................................................ 92 10.3.3 Glucometer Errors ................................................................................................................... 92 11 SPARES LIST OF THE TEMPUS IC.................................................................................94 12 CONFIGURING THE TEMPUS IC ....................................................................................95 13 SPECIFICATIONS AND STANDARDS ............................................................................98 13.1 Specifications ....................................................................................................... 98 13.1.1 Non-invasive Blood Pressure .................................................................................................. 98 13.1.2 ECG Recorder ......................................................................................................................... 98 13.1.3 ETC02 Sensor .......................................................................................................................... 99 13.1.4 SpO2 Sensor .......................................................................................................................... 101 13.1.5 Thermometer ......................................................................................................................... 102 13.1.6 Glucometer ............................................................................................................................ 103 13.1.7 Environmental Specifications ................................................................................................ 105 Temperature & Altitude: ................................................................................................ 105 Temperature Variation: ................................................................................................. 105 Humidity: ....................................................................................................................... 105 Operational Shocks & Crash Safety: ............................................................................. 105 Vibration: ....................................................................................................................... 105 Explosion Proofness: .................................................................................................... 106 Water Proofness: .......................................................................................................... 106 Fluids Susceptibility: ...................................................................................................... 106 Sand & Dust: ................................................................................................................. 106 Fungus Resistance: ...................................................................................................... 106 Salt Spray: ..................................................................................................................... 106 Magnetic Effect: ............................................................................................................ 106 Power Input: .................................................................................................................. 106 Voltage Spike: ............................................................................................................... 106 Audio Frequency Conducted Susceptibility – Power inputs: ......................................... 107 Induced Signal Susceptibility: ........................................................................................ 107 Radio Frequency Susceptibility (Radiated & Conducted): ............................................. 107 Emission of Radio Frequency Energy: .......................................................................... 107 Lightning Induced Transient Susceptibility: ................................................................... 107 Lightning Direct Effects: ................................................................................................ 107 Icing: ............................................................................................................................. 107 ESD: .............................................................................................................................. 107 Fire and Smoke Hazards: .............................................................................................. 107 13.1.8 Miscellaneous Features and Specifications .......................................................................... 108 13.1.9 Communications .................................................................................................................... 108 13.1.10 Tempus IC Device Classification ........................................................................................... 114 13.1.11 Standards Compliance .......................................................................................................... 115
Tempus IC User/Operator Manual- USA Page IV 41-1025-03A 14 SYMBOLS USED ON THE TEMPUS IC .........................................................................121 15 END USER LICENSE AGREEMENT ..............................................................................124 16 CHANGE HISTORY ........................................................................................................126
Tempus IC User/Operator Manual- USA Page 5 41-1025-03A 1 Introduction This manual is for the Tempus IC patient monitor. It is intended for use by US customers only. For customers outside the US please refer to the alternate user manual part number 41-1001. 1.1 Manufacturer's Address The Tempus IC is designed and manufactured by: Remote Diagnostic Technologies Ltd. The Old Coach House The Avenue Farleigh Wallop Basingstoke Hampshire RG25 2HT UK Tel +44 (0) 1256 362 400 Fax +44 (0) 1256 362 415 Email sales@rdtltd.com www.rdtltd.com 1.2 CE Statement Marking by the symbol indicates compliance of this device to the Medical Devices Directive 93/42/EEC and the Radio and Telecom Terminal Equipment Directive 1995/5/EC. The CE mark is accompanied by the number 0473 which is the reference number for the Notified Body who certify RDT’s quality system. A Declaration of Conformity in accordance with the above regulations has been made and is on file with RDT at the address in section 1.1. 1.3 FDA Prescription Statement Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician. 1.4 Proprietary Notice Information contained in this document is copyright © 2012 by Remote Diagnostic Technologies Limited ('RDT') and may not be reproduced in full or in part by any means or in any form by any person without prior written permission from RDT. The purpose of this document is to provide the user with adequately detailed information to efficiently install, operate, maintain and order spare parts for the Tempus IC. Every effort has been made to keep the information contained in this document current and accurate as of the date of publication or revision. However, no guarantee is given or implied that the document is error free or that it is accurate with regard to any specification. RDT reserves the right to change specifications without notice. Tempus ICTM, i2iTM and TempusNETTM are all trademarks of RDT. The Bluetooth® name and logo are owned by the Bluetooth® SIG Inc. and any use of this name or mark is under license. MyGlucoHealth® and Entra Health SystemTM are protected by registered trademarks and trademark applications of Entra Health Systems Ltd. Sennheiser™ is a trademark of Sennheiser electronic GmbH & Co. KG.
Tempus IC User/Operator Manual- USA Page 6 41-1025-03A 1.5 Use of This Manual The instructions and safety precautions provided in this manual must be observed during all phases of the operation, usage, service or repair of the Tempus or its accessories. Failure to comply with the information contained in this manual e.g. warnings, precaution, instructions etc. will violate the safety standards of design, manufacture and intended use of the product. RDT assumes no liability for customer failure to comply with the information contained in this manual. Users of Tempus IC and its accessories are advised to convey the following safety information to operating personnel and to incorporate applicable information into their own internal literature where necessary. 1.6 Patent Claims RDT has applied for patents covering Tempus IC and its communications technology in the following jurisdictions: Patents Pending (US No.2006/0287586 EP 1734458 A & other areas). 1.7 Limited Warranty Remote Diagnostic Technologies Limited ('RDT') warrants each new Tempus IC to be free from defects in workmanship and materials under normal conditions of use and service. For details please refer to the Terms and Conditions of Sale. Consumable items are expressly excluded from this Warranty. RDT's sole obligation under this warranty will be to repair or (at RDT's option) replace products that prove to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, RDT makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. The warranty shall be void if Tempus IC is in any way modified or if it is used with non-approved consumables, unless specifically authorised in writing by RDT, and RDT shall not be liable in any event for incidental or consequential damage. This warranty is not assignable. Full terms and conditions of sale are available from RDT and are provided with your order confirmation. 1.7.1 Service Support and Returns Repairs made under warranty to Tempus IC must be made by the manufacturer. If Tempus IC requires repair or return for any reason, please contact your local distributor or Remote Diagnostic Technologies at the address in section 1.1 in order to first obtain a returns reference (RMA) number. RDT reserves the right not to accept returns which have not first been provided with an RMA number. When calling, please be ready to quote the serial number of Tempus IC. The Tempus IC is designed to be as maintenance free as possible. The only user replaceable and user serviceable parts in the Tempus IC are those listed in section 10 of this manual. In the event that the device fails to operate correctly or in a way that is not described in this manual, stop using the device immediately and switch the device off immediately. Contact the manufacturer or distributor at once. Do not attempt any kind of corrective action and do not connect the device to a patient.
Tempus IC User/Operator Manual- USA Page 7 41-1025-03A 2 Warnings and Cautions 2.1 EMC Statement The Tempus IC remote patient monitor has been tested and approved to IEC/EN60601-1-2:2007. This means that the Tempus IC meets or exceeds the requirements for electrical medical equipment in terms of its levels of emitted electromagnetic radiation and its susceptibility to electromagnetic radiation from other devices. In addition, the Tempus IC has been tested according to the requirements of RTCA DO160-E section 21 category M. It should be noted that the Tempus IC may be affected by high levels of stray EM radiation from other electronic devices (even those which comply with relevant CISPR emission standards) that are being used in close proximity to it. As required by international medical device standards, the Tempus IC is intended for use in electromagnetic environments of ±6kV static contact (±8kV air discharge) and magnetic fields of 3A/m (50/60Hz). The Tempus IC is proof against radiated RF emissions from 80MHz to 2.5GHz to a level of 3V/m. In the event that the Tempus IC will be used in environments with RF levels exceeding this, please contact RDT for further information. 2.2 Indications for Use The Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. The Tempus IC is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident. The Tempus IC is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required. Tempus IC measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module). The Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight). 2.3 Contraindications The Tempus IC is not intended to be used on extremely small or extremely large patients; this limit is set by the physical limits of the ECG harness. The Tempus IC does not replace a physician’s care. The device is not intended for neonatal use. The device is not an apnoea monitor. The Tempus IC is not intended to be used in strong magnetic or electro-magnetic fields which are generated for medical purposes e.g. MRI. The Tempus is not for use with electro-cautery devices. The Tempus IC is not intended to allow a lay user to make any clinical decision for treatment or diagnosis. The Tempus IC ECG is not intended to be used on patients with prosthetic limbs. The Tempus IC is not intended to be a long-term monitor; it is only intended to be used in short, discrete incidents where the immediate health of the patient is in question. The Tempus IC is not intended to, and does not sound alarms for physiological parameters.
Tempus IC User/Operator Manual- USA Page 8 41-1025-03A 2.4 Warnings, Cautions and Notes KEYWORD DEFINITION WARNING Indicates a potentially harmful condition that can lead to personal injury. CAUTION Indicates a condition that may lead to equipment damage or malfunction. NOTE A point of particular interest or emphasis intended to provide more effective or convenient. 2.4.1 Tempus IC Warnings, Cautions and Notes WARNING It is essential to switch off the Tempus IC between applying it to different patients in order to ensure patient records remain separate. WARNING: The use of the symbol indicates that the user must read the user manual before using the product. WARNING: Only connect Tempus IC to IT and communications systems which are compliant with the relevant IEC standard e.g. IEC60950. Signal input and output connectors are only for connection to equipment complying with relevant IEC safety standards and must be configured to comply with IEC60601-1-1. WARNING: The user should not touch the patient at the same time as touching accessible conductive parts of the Tempus e.g. connectors. WARNING: Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician. WARNING: The Tempus IC is not intended for unsupervised patient monitoring. There are no audible or visible alarms. WARNING: Do not use device in the presence of flammable anaesthetics or fuels. WARNING: Do not autoclave, ethylene oxide sterilise, or immerse in liquid or immersing the sensors in liquid as it may cause sensor damage which may result in inaccurate readings. WARNING: ELECTRICAL SHOCK HAZARD when covers are removed. Do not remove covers. Refer servicing to qualified personnel authorised by RDT. WARNING: Device must be used in conjunction with clinical signs and symptoms. Device is only intended to be an adjunct in patient assessment. WARNING: Attention should be paid to the following EMC information prior to installing or using the device. WARNING: Verify normal operation if utilizing device adjacent to or stacked with other electrical equipment. WARNING: Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of the device. WARNING: The Tempus has been tested and found to comply with IEC/EN 60601-1-2. WARNING: Computers, cables and accessories not tested to IEC/EN60601-1-2 or equivalent IEC standards may result in increased emissions or decreased immunity of device.
Tempus IC User/Operator Manual- USA Page 9 41-1025-03A WARNING: Follow precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other equipment. WARNING: Only use Tempus IC with the relevant cables and peripherals provided by RDT. WARNING: Exposure of the wireless communication features of the Tempus IC or its accessories may be interfered with by other devices which operate at the same frequencies. WARNING: The sensors of the Tempus IC are only for contact with intact and undamaged skin. WARNING: Any device or accessory that has been dropped, damaged or subjected to harsh or extreme environmental conditions should be inspected by qualified service personnel prior to use to ensure proper operation. WARNING: The Tempus IC is not for use on neonates. WARNING: The device should not be used on patients undergoing defibrillation. The Tempus IC is protected against defibrillator discharge but rate meters and displays may be temporarily affected during defibrillator discharge but will rapidly recover. WARNING: There is no defibrillator synchronisation output on the device. Make no connections between the device and a defibrillator. WARNING: Device will not operate effectively on patients who are experiencing convulsions or tremors. WARNING: Device is not for apnoea detection. Device has not been tested or validated for use in apnoea detection. WARNING: Misuse or improper handling of the device (its sensors or cables) can cause damage which may lead to equipment failure or inaccurate readings. WARNING: Do not attempt to charge a non-rechargeable battery. Never charge, crush, heat or incinerate, short-circuit, deform, puncture, dismantle or immerse the batteries in any liquid. Remove batteries when discharged. WARNING: Only use rechargeable batteries and battery chargers specified by RDT. WARNING: Ensure patient cabling or tubing is carefully routed on device to reduce the possibility of patient entanglement or strangulation WARNING: All numerical, graphical and interpretive data should be evaluated with respect to the patient's clinical and historical picture WARNING: Do not attempt to insert any connections from the Tempus IC (including patient cables) directly into an electrical outlet WARNING: Explosion Hazard: DO NOT use the Tempus IC in the presence of flammable anesthetics or other flammable gasses. Use of the Tempus IC in such environment may present an explosion hazard. WARNING: Electrical Shock Hazard: Always disconnect the LoFlo sidestream Capnometer before cleaning. Do NOT use if it appears to have been damaged. Refer servicing to qualified service personnel. WARNING: Failure of Operation: If the Tempus IC fails to respond as described in this user guide; DO NOT use it until approved for use by qualified personnel. WARNING: Reuse, disassembly, cleaning, disinfecting or sterilizing of any single use items (such as the capnometer cannula) may compromise functionality and system performance leading to a user or patient hazard. Performance is not guaranteed if an item labelled as single patient use is reused. WARNING: Do not apply excessive tension to any cable. WARNING: Before use, carefully read these operating instructions. WARNING: Using a damaged patient sensor may cause inaccurate readings, possibly resulting in patient injury or death. Inspect each sensor. If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair
Tempus IC User/Operator Manual- USA Page 10 41-1025-03A center for help. WARNING: Using a damaged patient cable may cause inaccurate readings, possibly resulting in injury or death. Inspect the patient cable. If the patient cable appears damaged, do not use it. Contact your authorized repair center for help. WARNING: The USB connection must only be connected to non-mains powered peripherals (such as a mouse or keyboard) or to interface accessories provided by RDT (such as the USB-Serial Cable pn 01-1022). Any connections made to the USB port must be to medical or IT peripherals or communications systems which comply with the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection arrangements must be made in a manner compliant with IEC60601-1-1. WARNING: The Tempus is designed to enable a non-expert user to collect medical data from a patient and to then transmit that data to a response centre staffed by physicians, who will use this data to provide medical support and advice. Under no circumstances should non-expert users attempt to use data generated by the Tempus to make diagnostic or treatment decisions. If a physician is present at the incident, they can use the data from the Tempus to make diagnostic or treatment decisions. CAUTION: Do not disassemble the device. There are no user-serviceable parts inside. Refer servicing to the manufacturer. Changes or modifications not expressly approved by RDT could void the user’s authority to operate the equipment. CAUTION: Repairs or service activity not detailed in this manual or in accompanying documents must only be undertaken by personnel trained or authorized by RDT. CAUTION: Autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid may cause sensor damage which may result in inaccurate readings. CAUTION: This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the information in this manual before using the device. CAUTION: The Tempus IC may not operate correctly if used or stored outside the relevant temperature or humidity ranges described in the performance specifications of this manual. CAUTION: Only use only approved accessories supplied by RDT. CAUTION: DO NOT clean the IC or its accessories except as directed in this guide. CAUTION: DO NOT apply excessive tension to any of the Tempus IC cables. CAUTION: Read all instructions for use and specifications provided prior to use. CAUTION: Device is intended for use by persons trained in its operation. The operator must be thoroughly familiar with the information in this manual before using the device. CAUTION: The device is not intended to, and does not, sound alarms for physiological parameters. CAUTION: In the event that the device displays an error that is not described within this manual e.g. Windows applications errors, turn the device off and then on again. This should clear the error and allow normal operation to resume. Do not continue to use the device if such an error is displayed. If symptoms persist, please contact RDT. CAUTION: Device must be switched off between taking readings from different patients. CAUTION: Should the device become wet, wipe off all moisture and allow sufficient time for drying before operating. Take care to ensure that water or liquids are not spilt over the device or into its ventilation holes in the side corners. CAUTION: If the accuracy of any measurement is in question, verify the patient's vital sign(s) by an alternative method and then check the monitor for proper functioning.
Tempus IC User/Operator Manual- USA Page 11 41-1025-03A CAUTION: Follow local government regulations and recycling instructions regarding disposal and recycling of device and device components. CAUTION: The Tempus IC and its accessories use different types of batteries which includes rechargeable and non-rechargeable types. If any battery fails to hold a charge or otherwise becomes inoperable, the battery should be replaced and the old battery should be disposed of properly. RDT cannot dispose of used batteries. Dispose of batteries in accordance with applicable regulations which vary from country to country. (In most countries, the trashing of used batteries is forbidden and the end-users are invited to dispose them properly, eventually through not-for-profit profit organisations, mandated by local governments or organised on a voluntary basis by professionals). CAUTION: Pressing buttons and touch screen with sharp or pointed instruments may permanently damage the buttons and touch screen. Only fingers should be used to press these keys. CAUTION: Do not reconnect the headset to its docking pin when the main battery is very low or flat (less than 10% charge – as represented by a single flashing red LED on the battery charge indicator). Doing this could reduce the battery charge into a “deep discharge” state (where no battery lights come on). CAUTION: Only connect the device to communications systems which are compliant with relevant international safety standards e.g. IEC60950 for IT and telecommunications equipment. Only connect the device to communications systems which it is intended to be used with. CAUTION: Do not touch electrically live parts of other electrical systems while touching the patient. CAUTION: Use of monitoring during continuous nebulised medication delivery will result in damage to the device which is not covered by the warranty. Disconnect the capnometer sample line from the device, or switch off the device, during medication delivery. CAUTION: Observe proper battery polarity (direction) when replacing batteries. The batteries slide easily into place when correctly oriented and should not be forced. CAUTION: The mobile RF communications equipment contained within the device and its accessories can affect other medical devices that are in close proximity to the device. CAUTION: Use of the RF communications equipment contained in the device and its accessories may be prohibited in a number of areas. These include: on aircraft in-flight (including during take-off and landing), near defibrillators (that are in use), near other electronic medical devices and in hospitals. CAUTION: In addition, the use of the RF communications equipment contained in the device and its accessories may be prohibited in explosive atmospheres e.g. in fuelling areas, near fuel or chemical transfer or storage areas and in areas containing chemicals or particles such as grain, dust or metal powders. CAUTION: Do not transport or store the device with flammable gas, liquids or explosives. CAUTION: The use of the RF communications equipment contained in the device and its accessories may cause interference with some implanted pacemakers and other medically implanted equipment. A minimum distance of 2.3m (7.5 feet) must be maintained between the device and its accessories (containing RF communications equipment) and other medical equipment (including implantable medical devices such as defibrillators and pacemakers). Note that if such medical equipment has an electromagnetic interference immunity level of less than 3V/m (or 10V/m for implantable devices), this distance should be increased in line with the requirements of IEC60601-1-2:2007.
Tempus IC User/Operator Manual- USA Page 12 41-1025-03A If the intended patient has an implantable device (e.g. implantable pacemaker), do not use any of the Tempus IC’s RF communications equipment (e.g. Bluetooth® or WiFi) before using the device to record the patient's physiological data. After the data recording session is completed, move the device at least 2.3 m away from the patient, and then use it normally to communicate with the base station. Otherwise, radiofrequency radiation from the device (up to 63mW) may adversely impact the implantable pacemaker in the patient. If the patient's implantable device has an immunity level less than 10 V/m, the separation has to be greater than 2.3 m If you suspect interference is being caused, disconnect the connection to the response centre by pressing . Examples of interference could include visible interference on equipment displays, audible interference e.g. buzzing, from speakers of other equipment, or equipment unexpectedly changing state e.g. functions starting or stopping. Examples of visible interference on a PC display are shown below: Example of a PC display with no interference Example of a PC display with interference
Tempus IC User/Operator Manual- USA Page 13 41-1025-03A The SAR (Specific Absorption Rate) limit as dictated by the FCC (in the USA) is 1.6W/kg averaged over 1 gram of tissue. The Tempus IC has been tested against these SAR limits to maintain compliance with FCC RF exposure requirements. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. The antennas used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter except as defined in the FCC filing. CAUTION: In addition, a minimum distance of at least 10cm (3.94inches) must be maintained between the ear cup housing of a Sennheiser® VMX 200 wireless headset and a cardiac pacemaker or implanted defibrillator (ICDs). CAUTION: When using the device with portable satellite terminals such as Iridium handsets or GAN terminals, ALWAYS ensure that the terminal is provided with any applicable data adaptors and is set up to support data calls. It is recommends that Users thoroughly familiarise themselves with the operation their satellite terminals and perform a test connection BEFORE going into the field with the equipment. Advice on this can be sought from RDT if required. CAUTION: When using the device with GAN terminals, in order to avoid the risk of interference from the output beam from the antenna of the terminal with the operation of the device, ALWAYS ensure that the device is situated at least 6m behind the face of the antenna. Since the power of the GAN terminal’s beam is high (25W approx.), care should be taken to ensure that the antenna remains fixed and to maintain the device away from the face (and therefore the beam) of the antenna. CAUTION: RF energy may affect some electronic systems in motor vehicles, such as car stereo, safety equipment, etc. Check with your vehicle manufacturer’s representative to be sure that your product will not affect the electronic system in your vehicle. CAUTION: Do not use the Tempus IC’s Bluetooth® or WiFi communications on-board any aircraft where its use is prohibited. CAUTION: Do not use the Tempus IC during take-off or landing NOTE: The Tempus is intended for use in locations remote from emergency medical care. It should therefore only be used outside the USA (within the USA conventional emergency medical care should be contacted) except where it is used by a physician. NOTE: If all the battery lights remain off when the battery button is pressed, the battery may be in a “deep discharge” state. The battery is not damaged when in this state but will require an extended period on a charger (additional 2-3 hours) in order to restore normal operation. NOTE: Important! The Tempus IC is intended for use in the electromagnetic environment(s) specified in this manual. Users of this equipment should ensure that it is used in such environment(s). NOTE: The Tempus IC or its accessories contain no user serviceable parts except as detailed by this manual or accompanying documents. Refer service to qualified service personnel. NOTE: This product and its accessories are latex free. NOTE: After the life cycle of the Tempus IC and its accessories have been met, disposal should be accomplished following national and/or local requirements. NOTE: Operation of the device may be adversely affected in the presence of conducted electrical transients or strong electromagnetic or radio frequency sources such as electrosurgery and electrocautery equipment, HF radio transmission antenna, x-ray machines and high intensity infrared radiation. NOTE: All user and patient accessible materials are non-toxic. NOTE: Hazards arising from software errors have been minimised. Hazard analysis was performed to meet the requirements of EN14971 and IEC60601-1-4. NOTE: Each external connection and part of the device is electrically isolated.
Tempus IC User/Operator Manual- USA Page 14 41-1025-03A NOTE: Performance and safety test data are available on request from the address in section 1.1. NOTE: Device complies with Part 68 of the US FCC Rules and the requirements adopted by ACTA . The device is labelled with, among other information, a product identifier in the format US:AAAEQ###TXXXX. If requested, this number must be provided to the telephone company. NOTE: A plug and jack used to connect the device to the premises wiring and telephone network must comply with the applicable FCC Part 68 rules and requirements adopted by ACTA. A compliant telephone cord and modular plug is provided with this product. It is designed to be connected to a compatible modular jack that is also compliant. NOTE: The REN is used to determine the number of devices that may be connected to a telephone line. Excessive RENs on a telephone line may result in the devices not ringing in response to an incoming call. In most but not all areas, the sum of RENs should not exceed five (5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company. For products approved after July 23, 2001, the REN for this product is part of the product identifier that has the format US:AAAEQ##TXXXX. The digits represented by ## are the REN without a decimal point (e.g., 03 is a REN of 0.3). For earlier products, the REN is separately shown on the label. NOTE: If the device causes harm to the telephone network, the telephone company will notify you in advance that temporary discontinuance of service may be required. But if advance notice isn't practical, the telephone company will notify the customer as soon as possible. Also, you will be advised of your right to file a complaint with the FCC if you believe it is necessary. NOTE: The telephone company may make changes in its facilities, equipment, operations or procedures that could affect the operation of the equipment. If this happens the telephone company will provide advance notice in order for you to make necessary modifications to maintain uninterrupted service. NOTE: If the equipment is causing harm to the telephone network, the telephone company may request that you disconnect the equipment until the problem is resolved. NOTE: Connection to party line service is subject to state tariffs. Contact the state public utility commission, public service commission or corporation commission for information. NOTE: If your home or area of installation has specially wired alarm equipment connected to the telephone line, ensure the installation of the device does not disable your alarm equipment. If you have questions about what will disable alarm equipment, consult the supplier as described in section 1.7.1. NOTE: This equipment is not hearing aid compatible. NOTE: ALWAYS ensure that any satellite terminals e.g. GAN or Mini-M terminals, used with the device are powered from mains power supplies which are earthed. Using a non-earthed power supply with satellite terminals will cause interference on the ECG trace. Earthed power supplies will always have a three pin connector to plug the mains lead into, non-earthed power supplies will always have the following symbol on their label . In addition, when purchasing any replacement power supplies for satellite terminals, always ensure that the replacement has the same input and output voltage (V), current (A) and power (W) ratings, the same type and polarity of output connector and is approved to EN/IEC60950 (safety standard). Advice on this matter may be sought from RDT if needed. NOTE: GSM usage is restricted by the network availability, roaming agreements and local provision of circuit mode connections.
Tempus IC User/Operator Manual- USA Page 15 41-1025-03A NOTE: Users who own multiple device units should note that their device are likely to be pre-configured for different aircraft, yachts or other locations according to the customer’s needs. Consequently different device units owned by one User may not necessarily be compatible with all of the customer’s different aircraft, yachts etc. Users should refer to RDT’s delivery notes which will detail if specific device is configured for specific applications. Alternatively please check with a technical contact at RDT for confirmation. NOTE: Users should not put the device into service until they have been trained in its use and also (where appropriate) the device has been commissioned on their aircraft, vessel or other intended site of operation. NOTE: IP sealing is not guaranteed if the device is subject to rough handling, impact, improper use, rapid decompression NOTE: Device should be returned for service if it is subject to rough handling and IP sealing is needed to be relied upon. NOTE: The Tempus IC’s water ingress seals are warranted for 1 year from the date of manufacture. NOTE: The device specifications are subject to change without notice. NOTE: It is recommended that the device is connected to the response centre every month for a test patch. NOTE: The iAssist help processes on your Tempus IC may differ from the example iAssist help process used in this manual; however the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. NOTE: For optimum performance of the wireless communications, please make sure that there is no metal surrounding the Tempus IC. NOTE: Overbending the folding foot or RapdiPak clip could cause them to be damaged. Do not over-bend these items. NOTE: Take care when repacking cables to ensure they cannot be snagged or damaged in the RapidPak clip and the folding foot. NOTE: The Tempus IC should be repacked following the relevant instructions. Lost or damaged cables and accessories should be replaced with spares ordered from RDT. 2.4.2 LoFlo Sidestream Capnometer - Warnings, Cautions, & Notes WARNING: Do not operate the LoFlo sidestream Capnometer if it fails to operate properly, if it appears to have been damaged or when it is wet or has exterior condensation. WARNING: DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min +/- 10 ml/min from the airway or patients that can not tolerate the added dead space to the airway. WARNING: Do not connect the exhaust tube to a ventilator circuit. CAUTION: DO NOT sterilize or immerse the LoFlo sidestream Capnometer in liquids. CAUTION: DO NOT store the LoFlo sidestream Capnometer at temperatures less than -40º F (-40º C) or greater than 158º F (70º C). CAUTION: DO NOT operate the LoFlo sidestream Capnometer at temperatures less than 32º F (0º C) or greater than 104º F (40º C). CAUTION: Remove the LoFlo sampling kit sample cell from the receptacle when not in use. CAUTION: DO NOT stick appendage into sample receptacle. NOTE: Recommended operating temperature is 32º F (0º C) to 104º F (40º C).
Tempus IC User/Operator Manual- USA Page 16 41-1025-03A NOTE: Nitrous oxide, elevated levels of oxygen, helium , Xenon, halogenated hydrocarbons, and barometric pressure can influence the CO2 measurement.. 2.4.3 Pulse Oximeter Sensor - Warnings, Cautions, & Notes WARNING: Do not use this device in the presence of high EMI/RFI radiation. High EMI/RFI radiation may cause induced current to the SpO2 sensor resulting in patient injury. WARNING: This device may give inaccurate readings in the presence of strong electromagnetic sources, such as electrosurgery equipment. WARNING: This device may give inaccurate readings in the presence of computed tomography (CT) equipment. WARNING: This device must be used in conjunction with clinical signs and symptoms. This device is only intended to be an adjunct in patient assessment. WARNING: Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. Prolonged use may cause blisters, skin deterioration, and discomfort. WARNING: Incorrectly applied sensors may give inaccurate readings. WARNING: SpO2 measurements may be inaccurate in the presence of high ambient light. Shield the sensor area (with a towel, for example) if necessary. WARNING: Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, patent blue V (PBV), and fluorescein may adversely affect the accuracy of the SpO2 reading. WARNING: Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings. WARNING: Remove fingernail polish or false fingernails using the wipe provided before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. WARNING: Significant levels of dysfunctional hemoglogins, such as carboxyhemoglogin or methhemoglobin, will affect the accuracy of the SpO2 measurement. WARNING: Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin, porfimer sodium and metatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at least every hour and observe for signs of tissue damage. More frequent sensor site changes or inspections may be indicated depending upon the photodynamic agent used, agent dose, skin condition, total exposure time or other factors. Use multiple sensor sites. WARNING: Ethylene oxide sterilizing the sensor may lead to tissue damage when the sterilized sensor is placed on a patient. WARNING: Optical cross-talk can occur when two or more sensors are placed in close proximity. It can be eliminated by covering each site with opaque material. Optical cross-talk may adversely affect the accuracy of the SpO2 readings. WARNING: Obstructions or dirt on the sensor’s red light or detector may cause a sensor failure or inaccurate readings. Make sure there are no obstructions and the sensor is clean. WARNING: Under certain clinical conditions, pulse oximeters may display dashes if unable to display SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury.
Tempus IC User/Operator Manual- USA Page 17 41-1025-03A CAUTION: Unplug the sensor from the monitor before cleaning or disinfecting to prevent damaging sensor or monitor, and to prevent user safety hazards. NOTE: SpO2 averaging is the number of pulse beats over which the SpO2 value is averaged; pulse averaging is the number of seconds over which the pulse value is averaged. NOTE: DESAT trails were performed in the normal sensitivity mode. NOTE: Use proper disposal guidelines when discarding the device. 2.4.4 ECG Recorder Sensor - Warnings, Cautions, & Notes WARNING: The ECG device is not intended for use in a sterile environment. Do not use for direct cardiac application. WARNING: The ECG device is reusable WARNING: Do not attempt to insert the ECG device (including patient cables) into an electrical outlet WARNING: The ECG is for resting recordings and should not be used in stress testing environments WARNING: Ensure electrodes are connected only to the patient WARNING: Conductive parts of electrodes and connectors, including neutral electrode, should not contact other conductive parts including earth WARNING: The Tempus IC is rated as being proof against the effects of a defibrillator discharge. Follow these warnings if using an AED or defib with the Tempus IC: − Follow the instructions of the defibrillator or AED when using it with the Tempus IC. − Do not touch the patient during defibrillation − Do not touch the defibrillator’s paddle-electrode surface when discharging the defibrillator − Keep defibrillation electrodes well clear of other electrodes or metal parts in contact with the patient − Do not touch the patient, bed, or any conductive material in contact with the patient during defibrillation 2.4.5 The Blood Pressure Monitor - Warnings, Cautions, & Adverse Reactions WARNING: This device should not be used when oscillometric pulses may be altered by other devices or techniques such as External Counterpulsation (ECP) or Intra Aortic Balloon Pump Counterpulsation. WARNING: DO NOT use the Blood pressure monitor for any purpose other than specified in this manual. WARNING: DO NOT attach the cuff to a limb being used for IV infusions as the cuff inflation can block the infusion, potentially causing harm to the patient. CAUTION: Accuracy of any blood pressure measurement may be affected by the position of the subject, his or her physical condition and use outside of the operating instructions detailed in this manual. Interpretation of blood pressure measurements should be made only by a physician or trained medical staff. CAUTION: Hoses of a certain material and/or durometer may cause the module to perform in an improper fashion. Only use hoses provided by RDT. CAUTION: Incorrectly sized cuffs may cause measurement inaccuracy or errors.
Tempus IC User/Operator Manual- USA Page 18 41-1025-03A CAUTION: If the blood pressure cuff is on the same limb as a pulse oximeter probe, the oxygen saturation results will be altered when the cuff occludes the brachial artery. CAUTION: To obtain accurate blood pressure readings, the cuff must be the correct size, and also be correctly fitted to the patient. Incorrect size or incorrect fitting may result in incorrect readings. CAUTION: When a cuff is going to be positioned on a patient for an extended length of time, be sure to occasionally check the limb for proper circulation. CAUTION: Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the formation of urticaria (allergic reaction including raised edematous patches of skin or mucous membranes and intense itching) caused by the fabric material of the cuff. CAUTION: Petechia (a minute reddish or purplish spot containing blood that appears in the skin) formation or Rumple-Leede phenomenon (multiple Petechia) on the forearm following the application of the cuff, which may lead to Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets associated with hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.
Tempus IC User/Operator Manual- USA Page 19 41-1025-03A 3 Introduction to the Tempus IC 3.1 Product Description and List of Features Colour iAssist help processes are provided to assist the user in every stage of use. Everything that is displayed on the Tempus IC screen is simultaneously seen at the response Centre, enabling the medical expert to fully interact with the operator. The medical expert can, in fact, fully control Tempus IC if required, giving added comfort to the operator and patient at the remote location. Tempus IC in Use The Tempus IC sends all of its measurements and displays via the telephone connection to the response centre, where the displays are duplicated. The medical expert at the Response Centre is also able to annotate (with words, symbols and markings) and send back the still video picture to better illustrate the verbal instructions being given to the operator at the remote location. If necessary, the expert can take control of most functions of the Tempus IC, giving added comfort to both the user and patient.
Tempus IC User/Operator Manual- USA Page 20 41-1025-03A 4 Introduction to the Tempus IC 4.1 Tempus IC Device The Tempus IC is a multi-parameter vital signs monitor which connects to a dedicated Response Centre. Connection is achieved using different communications technologies, refer to the Modes Menu on your Tempus for details of what communications systems it can be used with. A physician may use the Tempus IC as a stand-alone diagnostic device (without it being connected to the Response Centre). The Tempus IC provides the following information about the patient from its sensors: • Pulse rate • Oxygen saturation (SpO2) • Blood pressure • 12 lead Electrocardiograph (ECG) • End tidal CO2 (ETCO2) • Respiration rate • Temperature • Blood glucose level These readings are transmitted via a communications link to a computer at a response centre which enables the physician to see all the vital signs data. Additionally, the Tempus IC includes a colour video camera which is capable of sending colour still images to the response centre. The following sections describe how each of the sensors, the camera and communications systems work. The Tempus IC consists of a enclosure which is overmoulded with rubber to make it resistant to shock. The enclosure also includes a rear clip which provides storage for the SpO2 sensor, the NIBP cuff and communications cable. The Tempus IC 4.1.1 Tempus IC Front The front of the Tempus IC has a large screen which is fitted with a touch-screen. The front panel houses two keypads which are graphically labelled with their function. Also present is a jog wheel which can be used to scroll through instructions. Jog Wheel Deployable Feet Touchscreen Battery Membrane buttons
Tempus IC User/Operator Manual- USA Page 21 41-1025-03A 4.1.2 Tempus IC Base The base of the Tempus IC houses the battery. 4.1.3 Tempus IC Rear The rear of the Tempus IC houses the RapidPakTM clip (discussed above) and the Bluetooth® Headset. This item is docked onto a connector which enables the VSM to top the charge of the headset up automatically on a regular basis, thus ensuring the headset is always ready to use. Also on the rear is the aperture for the camera and backlight, this aperture is labelled for aesthetic purposes. The clip carries a general product label for regulatory purposes and also two labels which help guide the user to repack the SpO2 sensor and the comms cable. The top of the clip carries a product-specific brand also. 4.1.4 Tempus IC Sides The left side of the device contains four connectors for: • ECG - blue, • NIBP – white latching connector; • SpO2 – orange; • ETCO2. – yellow. Normally the NIBP and SpO2 connectors will have their mating half attached at all times. Left Side of the Tempus The right side of the VSM houses the non-medical connections. These comprise: • USB – this is reserved ONLY for non-mains powered USB peripherals (such as mouse and keyboards) approved for use with the Tempus IC by RDT. It is also for use with the USB - Serial Cable (part number 01-1022) for customers using Iridium or other serial satcoms systems. WARNING: The USB connection must only be connected to non-mains powered peripherals (such as a mouse or keyboard) or to interface accessories provided by RDT (such as the USB-Serial Cable pn 01-1022). Any connections made to the USB port must be to medical or IT peripherals or communications systems which comply with the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection arrangements must be made in a manner compliant with IEC60601-1-1.
Tempus IC User/Operator Manual- USA Page 22 41-1025-03A • RJ-45 Ethernet – use only the Ethernet Cable pn 01-1021 or Dual Modem Cable pn 01-1014 supplied by RDT • Power – use only the Cincon TR60M12 power supply pn 01-1017 provided by RDT • Audio – this is only for use with the Wired Headset pn 01-1019 supplied by RDT The RJ-45 connector provides the Ethernet connection (the Ethernet cable is normally fitted). Communications Connection Panel
Tempus IC User/Operator Manual- USA Page 23 41-1025-03A 5 Using the Tempus IC NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. 5.1 Controlling the Tempus IC The Tempus IC is graphically rich and provides audio feedback from the device in the form of beeps, tones and error messages. The feedback differs depending on if the user presses active or inactive parts of the touchscreen. At any time, if the user is unsure of what to do they may press either of the following two buttons on the front of the device: the Help button - this will take you to a set of menus. the Home button - this returns the unit to the results screen. 5.1.1.1 Layout of Instructions on the Tempus IC The Tempus IC provides the user with complete instructions on how to use it. Every step is detailed in pictures with accompanying text instructions. There are instruction processes for everything the user will need to do with the device:  from obtaining a voice and data connection to the GMS,  through applying all the medical devices;  and then cleaning, repacking and replenishing the device. The help screen shows a typical screen from the Tempus IC. It shows that there are three distinct areas on the screen that give different types of information. 1. Status Bar This shows if the voice and data links are connected, if ECGs or pictures are being transmitted and what the time is when recorded. 2. Process Instructions This area contains the graphical pictures and text instructions that show you how to use the device. This takes the user through each activity one or two steps at a time. 3. Touch Screen Buttons In this example there are two buttons at the bottom of the touchscreen. In all cases the user will press the button on the bottom right of the screen to progress onto the next step in the process.
Tempus IC User/Operator Manual- USA Page 24 41-1025-03A Example of the Tempus IC Screen Layout 5.1.1.2 Progressing through Help Processes As mentioned above, the Tempus IC breaks all processes down into small steps. These steps are shown on the screen in one or two at a time. The user can see how many steps there are in any process by looking at the Process Ribbon near the top of the screen. Example of the Process Ribbon In the example shown above, the screen shows that the process has 6 steps and that the device is showing steps 1-2. The user follows the instructions given on the screen, ensuring that they review both the image and the text. Once they have completed both steps they proceed onto the next steps by pressing the Next touchscreen button. Pressing this will bring up the instructions for the next 1 or 2 steps in the process. Similarly they can go back to earlier steps by pressing the Previous touchscreen button. Status bar Help process graphics and instruction Touch screen buttons Process Ribbon
Tempus IC User/Operator Manual- USA Page 25 41-1025-03A Example of the Middle Steps of a Process At the end of a process, the Next touchscreen button changes to show an icon that relates to starting the action that the process has prepared for. So at the end of the process that has been shown in this example, the user would start the voice link connection. Example of the End of a Process 5.1.1.3 Getting Help As mentioned earlier, the user can get help at any time by pressing the button at any time. This will bring up the Help Menu. There are multiple sequential menus covering different aspects of using the Tempus IC. For example, when the first Help Menu is on the screen, the next menu (Cleaning and Repacking Menu) can be accessed by pressing the Next touchscreen button. Icon shows end of process Process Ribbon complete Process Ribbon updated Next button to progress to next step Previous button to return to last step
Tempus IC User/Operator Manual- USA Page 26 41-1025-03A Example of the Help Menu Example of the Cleaning and Repacking Menu The user can move backwards and forwards through the Menus by pressing the Next and Previous touchscreen buttons. From the Help Menu, press the Next button to bring up the Cleaning and Repacking Menu
Tempus IC User/Operator Manual- USA Page 27 41-1025-03A 5.2 Explanation of the Tempus IC Screen Tempus IC screen normally divides into two sections: • Connection status and time of day at the top • Instrument readings in the middle Example of the Tempus IC Screen Display 5.2.1 Status Bar – Clock (Time Stamp) The time of day is shown in Greenwich Mean Time (GMT), which is also known as Universal Time Co-ordinate (UTC). Tempus IC has an internal clock which is automatically synchronised to an accurate time reference at the Response Centre as soon as a call is made. Example of the Tempus IC Screen Display 5.2.2 Status Bar – Bluetooth® Indicator The Bluetooth® indicator identifies the number of Bluetooth® peripherals that are connected to the device, i.e. 1 sensor at this time. NOTE: It does not identify the specific peripheral connected to the Tempus IC. Bluetooth® Peripheral Indicator Status bar Instrument Readings Bluetooth Indicator Time in GMT
Tempus IC User/Operator Manual- USA Page 28 41-1025-03A 5.2.3 Status Bar - WiFi Indicator WiFi Status Indicator This indicator is displayed when the Tempus IC is connected to the Response Centre using WiFi communications technology. 5.2.4 Status Bar – GSM/GPRS Indicator GSM Status Indicator This indicator is displayed when the Tempus IC is connected to the Response Centre using GSM or GPRS communications technology. • Note that the display shows 5 coloured bars under the GSM symbol. • A single red bar means that a GSM or GPRS network is present but the signal strength is not sufficient to support a data connection • Two orange bars means that a data connection can be made but that the performance may be impaired. • Three to five green bars means that the signal strength is sufficient for a data connection. NOTE: The Tempus IC uses GSM and GPRS networks to make a data connection. This requires the network signal strength to be better than is required for a conventional GSM handset (which makes a voice only connection). Users should note that the signal strength readouts from the Tempus are not comparable to those of third-party handsets as the scale, setting, sensitivity and networks between the two devices may be different. 5.2.5 Instrument Readings This section of the screen shows the results (if any) from the five different medical devices (ECGs are displayed separately). Each of the three areas shows more than one piece of information i.e. data taken, time taken and type of units are displayed. Descriptions of the instrument readings are contained in the sections of this manual which describe each instrument. When iAssist help processes are displayed, they take up the space normally occupied by the instrument readings and the status indicators. All of the measurements except blood pressure and ECG are continuous, that is they are taken automatically without operator intervention. Data from these measurements is sent automatically to the Response Centre in real-time (if the data line is active), otherwise the measurements are memorised and sent when the data line is next active. • ECG measurements produce a lot of data which takes a few minutes to transmit to the Response Centre. ECG measurements can be initiated manually by the operator or remotely by the Response Centre. All data which is generated by the Tempus IC is automatically time-stamped. WiFi Indicator GSM / GPRS indicator
Tempus IC User/Operator Manual- USA Page 29 41-1025-03A 5.2.6 Instrument Status Indicators The Instrument Status indicators show what each instrument is doing. The status can be one of the following: Measuring The instrument is currently taking a reading Idle The instrument is currently idle On timer The instrument is making timed measurements (e.g. blood pressure) and will make another measurement in due course. Disabled The instrument is disabled, possibly due to a fault (see Troubleshooting in section 10.3) Additionally, further informative Status messages may appear during readings (e.g. press ’STOP’ on the touch screen to stop reading during a capnometer measurement). When iAssist help processes are displayed, they take up the space normally occupied by the instrument readings and the status indicators. 5.3 Device Sensors All of the measurements made by the Tempus IC are transmitted in real time except the ECG (and digital pictures) which is first recorded and then transmitted to the Response Centre. ECG data and digital pictures take the following amount of time to send to the Response Centre: • 12 lead ECG – 2-3 minutes* • Digital picture – up to 1 minute * These times are for guidance only and are based on the worst case communications system (off-aircraft satellite link running at 2.4Kbaud V22BIS) and may vary depending on the quality of the connection. Higher bandwidth connections (e.g. using Inmarsat Swift 64, Fleet 77, B-GAN or Swift Broadband) will provide lower transmission times. 5.3.1 Pulse Rate and Oxygen Saturation (SpO2) Pulse rate and oxygen saturation are detected by a reusable finger probe. This probe contains a visible (red) and invisible (infrared) light source and matching sensors. The sources and sensors are arranged so that the lights shine through the patient's finger when it is inserted into the clip. An amount of light also reaches the sensor via scattering within the skin. It is also important that the sensor is not used on the same arm as the blood pressure cuff, because false readings may occur when the cuff is inflated. Readings will not be obtainable from patient’s with nail varnish or polish, consequently the Tempus IC is stocked with nail varnish removing wipes in the bag. In the event that these are needed, the operator should follow the instructions on the wipe. 5.3.2 Blood Pressure Tempus IC uses non-invasive techniques to measure the patient's blood pressure. A pump within Tempus IC inflates the reusable blood pressure cuff around the patient's arm. Circulating blood within the arm causes slight changes (oscillations) in the cuff pressure, which can be detected and measured. As the inflation pressure changes, the systolic, diastolic and mean arterial pressure can be measured. This method of blood pressure measurement provides accurate readings provided that the correct size of cuff is used and the specified operating precautions are observed. 5.3.3 Electrocardiograph (ECG) Electrical currents influenced by the cardiac impulse flow through the body tissue around the heart. Tempus IC uses 10 electrodes (in a pre-set reusable apron configuration) placed mainly on opposite sides of the heart to detect these currents.
Tempus IC User/Operator Manual- USA Page 30 41-1025-03A The position of the electrodes is critical and so Tempus IC uses a specially moulded electrode apron which has nine of the electrodes positioned in the correct places to pick up the signals. The tenth electrode is positioned separately on the patient's leg. The electrode apron is made of elastic material so that as it stretches to accommodate different sizes of patient, the positions of the electrodes vary to maintain correct placement. 5.3.4 End Tidal CO2 (ETCO2) and Respiration Rate The Capnometer CO2 module is used to monitor continuous carbon dioxide and report the End Tidal carbon dioxide (ETCO2), inspired CO2 and respiratory rate values of non-intubated adult patients. The Capnometer CO2 module is used for the continuous measurement of CO2 (carbon dioxide) and respiratory rate. The capnometer uses a Sidestream sampling system with a low sampling rate that is used to measure the CO2. A tube inserted into the patient's nostrils detects samples of their exhaled breath. The tube is connected to a pump within the module which draws the sample through a measuring chamber. In the capnometer, infrared light is generated by the sensor and beamed through the sample cell to a detector on the opposite side. CO2 from the patient that is aspirated into the sample cell absorbs some of this infrared energy. The monitor determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. ETCO2 is displayed as a partial pressure in millimetres of mercury (mmHg). Respiration rate is calculated by measuring the time interval between detected breaths. 5.3.5 Temperature The thermometer that is provided is an infra-red tympanic device used for spot-checking a patient’s temperature. This is provided with disposable covers that should be changed with each measurement. The thermometer operates by measuring the patient’s temperature in the end of the ear canal (across the tympanic membrane). This is detected and measured using an infra-red detector that is built in to the thermometer’s head. The thermometer displays the reading on an LCD screen built into its handle and communicates the reading to the Tempus using Bluetooth® technology. The thermometer’s Bluetooth® radio must be “paired” with the Tempus before it can be used. The thermometer’s reading can be presented in ºC or ºF. 5.3.6 Blood Glucose level The glucometer that is provided with the Tempus is for spot-checking a patient’s blood glucose level. The glucose enzyme oxidase on the test strip reacts with the glucose in the blood sample and the result is displayed as a blood glucose level on the meter. The glucometer displays the reading on an LCD screen built into the glucometer and communicates the reading to the Tempus using Bluetooth® technology. The glucometer’s Bluetooth® radio must be “paired” with the Tempus before it can be used. The glucometer’s reading defaults to be presented in mg/dl. 5.4 Digital Camera A miniature digital camera is mounted in the unit. Images from this camera can be sent to the Response Centre to provide the physician with a view of what is happening to the patient. Moving pictures from the camera are captured by the Tempus IC and displayed on the screen. Still images require as much as 1 minute to transmit on a low-speed (2k5baud) link. Links with greater bandwidth will transmit the picture in less time.
Tempus IC User/Operator Manual- USA Page 31 41-1025-03A 5.5 Voice and Data Communications The Tempus IC can connect over either modem connections, over serial channels and over wired or wireless (WiFi) Ethernet networks. The Tempus IC will be pre-configured by RDT to operate over the user’s network. NOTE: RDT recommends that users perform a test connection to the response centre every month in order to verify that their communications remain open for the Tempus to use. NOTE: The Tempus IC operates over third-party communications links, such as telephone lines, GSM or satellite links and the Internet. RDT does not accept liability for the failure of these links to reliably transmit information from RDT’s products. Users are reminded that it is their responsibility to ensure that GSM network and other communications contracts are maintained and suitably setup and configured for the areas in which they need to be used.
Tempus IC User/Operator Manual- USA Page 32 41-1025-03A 6 Setting Up NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. 6.1.1 Unpacking the Tempus IC The Tempus IC is supplied from the factory in protective outer packaging. No special precautions are required when unpacking the Tempus IC. You do not need to keep the packaging. RDT recommends that the equipment is inspected and tested on receipt to confirm that the unit has not been damaged and that all expected items and accessories have been received and are in working order. New batteries should be charged up for at least 4 hours on receipt. 6.2 Tempus IC Bag The Tempus IC bag is a custom design part made from moulded rubber. It is provided with a shoulder strap and carry handle. The bag provides a main storage area for the Tempus IC (including windows to check the battery status and turn the device on externally to avoid the user opening the bag to do this), a storage area for the ECG harness, a range of pockets for consumables in the lid and a range of pockets for accessories and consumables on the rear. Each bag contains the following items: • 1 Tempus IC fully packed including battery, Adult BP cuff and hose, SpO2 probe and Ethernet cable and Bluetooth® Headset o The headset will be one of two different types, the usage of which is described in this manual, see sections 7.2 and 10.2.5. • 1 Vial of Glucometer Strips • 1 ECG spray • 5 AlcoWipes • 5 Nail varnish wipes • 1 pack of 10 thermometer covers with application tool • 1 pack of 3 glucometer lancets • 1 Bluetooth Thermometer • 1 Bluetooth Glucometer • 1 pack of Vinyl Gloves (pair) • 2 Extension Reels** • 1 Wired Headset • 1 Consumables Replenishment kit • 1 Glucometer Replenishment kit • 1 Lo-Flo® Capnometer • 2 Capnometer Cannula - Adult Nasal • 1 Blood Pressure Cuff – Large Adult • 1 Blood Pressure Cuff – Child • 1 Dual Modem Cable
Tempus IC User/Operator Manual- USA Page 33 41-1025-03A • 1 Ethernet Cable to Modem Adaptor *** • 1 USB - Serial Cable*** ** Note: non-commercial aviation users who do not use Iridium satcoms systems are provided with a single extension reel. Some commercial aviation users may be provided with three RJ11 Extension reels and one single modem cable. *** Note: not supplied to commercial aviation customers Refer to section Error! Reference source not found. for details of how to obtain further supplies of these disposable items. In addition, the Tempus IC is supplied with the following accessories which are not packaged in the Bag: • 1 Mains Power Supply • 1 Mains Cable Pack • 1 Battery Charger • 1 spare battery • 1 Accessory Pouch (note this is only supplied to commercial aviation customers) • 1 User manual (CD-ROM) The Tempus IC Bag Window to access the ON/OFF button Window to access the Battery charge indicator
Tempus IC User/Operator Manual- USA Page 34 41-1025-03A The Bag open with the Tempus IC removed 6.3 Switching On 6.3.1 Immediately after Switching On Note The Tempus IC takes up to one minute to become ready for operation after switching on. It is recommended that you switch on Tempus IC at the same time as you remove it from its storage location rather than when you arrive at the patient. To switch on the Tempus IC, press and hold the button on the front panel for 3 seconds. Release the button when the lamp at the top left corner of the button starts flashing green. The device is ready for use when the LED shines green constantly. If no buttons are pressed within 8 minutes, the unit will switch off automatically to save battery power. CAUTION: Do not press any of the control buttons until the first iAssist help process artwork is displayed on the screen. After switching on, the Tempus IC goes through a pre-defined set of iAssist help processes. These are: • Making the data connection • Using the headset and making a voice connection • Transmitting a digital picture • Blood Pressure and Pulse Oximeter Consumables in colour-coded pockets Tempus IC location ECG Harness Accessories and Consumables in colour-coded pockets
Tempus IC User/Operator Manual- USA Page 35 41-1025-03A You can press to jump straight to the results screen, or any other button to get help for that instrument e.g. pressing will bring up the first Help Menu or pressing will bring up the help menu for the capnometer.
Tempus IC User/Operator Manual- USA Page 36 41-1025-03A 7 Establishing Communication with the Response Centre The first step for using the Tempus IC is to establish communication with the Response Centre. To do this you will need to: • Ensure the device is set to use an appropriate communications Mode. • Connect the Tempus IC to the Response Centre. • Fit the Headset comfortably in your ear. It is possible for a physician to use Tempus IC as a standalone diagnostic tool without connecting to the Response Centre. Under these circumstances, just press the appropriate measurement function button to access that function. It is still possible to be connected to the Response Centre at any time by pressing the Connect button. The Tempus IC can also be left running with the data link connected but the voice link disconnected i.e. if the Response Centre physician wishes to continue monitoring the patient for a long duration but without keeping the voicelink open with Tempus IC User. In this case the voicelink can be reconnected at any time by pressing the Connect button. 7.1 Making the Phone Connection Press the button on the touch screen to get instructions on how to setup and connect the data connection. Note that these instructions will appear by default every time you turn the unit on. When you have followed the instructions and have pressed the button, the Wireless Headset screen will appear. Dialling the Data Connection If the Response Centre cannot be contacted, this could be due to errors in the way that the connection has been attempted (see section 10.3 of this manual for Troubleshooting information). Help will be given in the form of iAssist help process, follow the instructions given and wait for a few minutes before trying again.
Tempus IC User/Operator Manual- USA Page 37 41-1025-03A If your Tempus has been configured for automatic redialling, then it will attempt to connect to the Response Centre if the first call fails. The system will indicate the redial process by displaying a number over the Data Link status indicator. The system will attempt a number of redials (typically 3), and will display the corresponding number over the Data Link status indicator bar. 7.2 Fitting the Headset and Making the Voice Connection After dialling the data link the device will by default bring up instructions to fit the wireless headset. Follow the onscreen instructions and at the end of the process press the button on screen to dial the voice link. It is important to have attached the headset before dialling as the voice connection to the response centre can be made quickly. Remember that often the voice connection will be made over a satellite link so you may experience background noise or drop-outs. RDT recommends that you adopt a process of only one person speaking on the line at a time and then handing over to the other speaker by saying “over” or similar. 7.2.1 Using the Bluetrek Wireless Headset The Tempus IC uses the G3 headset provided by Bluetrek®. Note that the headset will be supplied in a charged state and its charge level is automatically maintained so long as it is regularly docked on the charging pin on the back of the device. It should also be noted that the G3 is a Bluetrek® wireless device. It is supplied “paired” with the Tempus IC. You cannot use different wireless headsets with the Tempus IC and RDT recommends that you do not attempt to use the G3 supplied with the Tempus IC with any other wireless devices (including other Tempus ICs or other communications devices such as mobile phones). Each G3 is “paired” to only the Tempus IC to which it is attached on delivery. While attaching the G3 to other Tempus IC units will not cause any damage, users should avoid this practise as it may cause confusion and ultimately prevent voice calls from being made when needed. If the G3 is lost or is damaged, contact RDT for a replacement. RDT recommends that the Bluetrek instructions (that are provided with the Tempus IC) are read in addition to the instructions below. Example of the Bluetrek Wireless Headset IAssist help process
Tempus IC User/Operator Manual- USA Page 38 41-1025-03A NOTE: If you do not wish to use the wireless headset, a wired headset is provided in the bag as an alternative. To switch to the wired headset press the button on the touch screen as identified in the above screens and follow the on-screen instructions showing you how to use it. Example of the Wired Headset IAssist help process NOTE: To switch to the Wireless Headset press the button on the touch screen as identified in the above screen. Setting Up the Bluetrek Bluetooth® Headset To use the Bluetooth® headset follow the on-screen instructions. When the headset is turned on, the Tempus will attempt to find it. During this time (20 seconds) a countdown will be displayed. Once the Tempus has located the headset it will confirm this on screen before resuming with the voice connection instructions.
Tempus IC User/Operator Manual- USA Page 39 41-1025-03A Once the voice connection process has been completed, press the Dial Voice button to start the voice connection process. NOTE: When using VoIP, the voice connection may take 10-15 seconds to setup after the “Dial Voice” button has been pressed. 7.2.1.1 Introduction to the Bluetrek Wireless Headset The headset has 3 buttons: • TALK • VOL + • VOL – Voice Connection Process Instructions – Last Step Press here to start the Voice connection Bluetrek Bluetooth® Linking Error If the Headset is not turned on then communications between it and the Tempus will not start, in this event the Tempus will display a screen asking for the instructions to be repeated
Tempus IC User/Operator Manual- USA Page 40 41-1025-03A 7.2.1.1.1 Wearing the Bluetrek Wireless Headset To put the headset on, follow the instructions given on screen. Note that the ear clamp is made from soft material. It can be flexed and shaped to fit your ear. You should ensure the speaker is properly inserted into your ear. 7.2.1.1.2 Controlling the Bluetrek Wireless Headset To turn the headset on, remove it from its dock and press and hold the talk button for 2-3 seconds until the blue indicator light is on. A beep (2 tones) can be heard in the speaker. Release the talk button as soon as the headset is on. NOTE: If you keep the talk button held down after the headset is on, you can put the headset into pairing mode. This is not desirable as it could potentially cause the headset to cease being paired with the Tempus IC and thus prevent it from operating with the device. Airing mode can be recognised by the indicator light slowly flashing red and then blue. If the headset is inadvertently put into pairing mode it should be placed back onto the docking pin on the Tempus to turn the headset off; the voice call should be disconnected and re-initiated. You can check if your headset is on by pressing the talk button once. If the indicator light flashes blue then this means the unit is on. You do not need to switch the headset off, this is achieved by docking the headset back onto the Tempus IC. If you do wish to turn the headset off, press and hold the talk button for 5 seconds until the indicator light first flashes blue and then goes red. NOTE: If you turn the headset off during a call, you will not be able to receive the call again with the headset i.e. if you turn the headset back on you will not hear the call again. If the headset is turned off during a call, disconnect the call using the Tempus IC and then re-initiate the connection again following the on-screen instructions. To adjust the volume during a call, press the “vol+” button or “vol-“ button on the headset.
Tempus IC User/Operator Manual- USA Page 41 41-1025-03A NOTE: If you press and hold the “vol+” button for 2 seconds you will mute the headset. A periodic tone can be heard in the speaker when the microphone is muted. To release muting, quickly press the “vol+” button on the headset. RDT does not recommend that you use the muting function as this could cause confusion during a call. If you need to adjust the volume of the headset of the wireless headset (the wired headset has no volume controls) after you have connected the voicelink, you can get instructions on how to adjust the volume by pressing the button. This is shown the first time you go into the camera iAssist process and the first time you go into the blood pressure and pulse oximetry process after switching on. You can also access the same instructions by pressing the Headset button on the main help menu after you have connected the voicelink. Headset Help Button Pressing the Headset Help button will bring up an iAssist process. This contains four different steps, each of which gives instructions on addressing a different type of issue e.g. you can’t hear the response centre, they can’t hear you etc. iAssist Process for Adjusting the Bluetrek Wireless Headset’s Volume
Tempus IC User/Operator Manual- USA Page 42 41-1025-03A 7.2.2 Using the Sennheiser VMX 200 Wireless Headset The Tempus IC uses the VMX 200 headset provided by Sennheiser®. Note that the headset will be supplied in a charged state and its charge level is automatically maintained so long as it is regularly docked on the charging pin on the back of the device. It should also be noted that the VMX 200 is a Sennheiser® wireless device. It is supplied “paired” with the Tempus IC. You cannot use different wireless headsets with the Tempus IC and RDT recommends that you do not attempt to use the VMX 200 supplied with the Tempus IC with any other wireless devices (including other Tempus IC or other communications devices such as mobile phones). Each VMX 200 is “paired” to only the Tempus IC to which it is attached on delivery. While attaching the VMX 200 to other Tempus IC units will not cause any damage, users should avoid this practise as it may cause confusion and ultimately prevent voice calls from being made when needed. If the VMX 200 is lost or is damaged, contact RDT for a replacement. RDT recommends that the Sennheiser instructions (that are provided with the Tempus IC) are read in addition to the instructions below. Example of the Sennheiser VMX 200 Wireless Headset IAssist help process NOTE: If you do not wish to use the wireless headset, a wired headset is provided in the bag as an alternative. To switch to the wired headset press the button on the touch screen as identified in the above screen and follow the on-screen instructions showing you how to use it. Instructions on using the wired headset can be found here Press here for the next instructions in the process
Tempus IC User/Operator Manual- USA Page 43 41-1025-03A Example of the Wired Headset IAssist help process NOTE: To switch to the Wireless Headset press the button on the touch screen as identified in the above screen. Setting Up the Sennheiser VMX 200 Wireless Bluetooth® Headset To use the Bluetooth® headset, follow the on-screen instructions. When the headset is turned on, the Tempus will attempt to find it. During this time (20 seconds) a countdown will be displayed. Once the Tempus has located the headset it will confirm this on screen before resuming with the voice connection instructions.
Tempus IC User/Operator Manual- USA Page 44 41-1025-03A Sennheiser Bluetooth® Linking Error Voice Connection Process Instructions – Last Step Once the voice connection process has been completed, press the Dial Voice button to start the voice connection process. NOTE: When using VoIP, the voice connection may take 10-15 seconds to setup after the “Dial Voice” button has been pressed. 7.2.2.1 Introduction to the Sennheiser VMX 200 Wireless Headset The headset has 3 buttons: If the Headset is not turned on then communications between it and the Tempus will not start, in this event the Tempus will display a screen asking for the instructions to be repeated Press here to start the Voice connection
Tempus IC User/Operator Manual- USA Page 45 41-1025-03A • Volume up • Volume down • Multi-function button NOTE: Users should avoid using the headset speaker volume controls. The speaker volume can be controlled through the Tempus IC and is preset to maximum, see Error! Reference source not found.. 7.2.2.1.1 Wearing the Sennheiser VMX 200 Wireless Headset To put the headset on, follow the instructions given on screen. Simply put the headset into your ear (either ear), i.e. see Sennheiser instruction manual provided with the Tempus IC). You should ensure the speaker is well seated in your ear so it feels stable. 7.2.2.1.2 Controlling the Sennheiser VMX 200 Wireless Headset To use the headset: Press the green dial button. Following the on-screen instructions remove the headset from its dock. Following the on-screen instructions press the Multi-function button once (for 1 second or less). The light on the headset will flash blue. The Tempus IC will go through a process to link to the headset via Bluetooth®. Following the on-screen instructions put the headset into your ear. Following the on-screen instructions press the Connection button on the touchscreen.
Tempus IC User/Operator Manual- USA Page 46 41-1025-03A NOTE: If you keep the talk button held down after the headset is on, you can put the headset into pairing mode. This is not desirable as it could potentially cause the headset to cease being paired with the Tempus IC and thus prevent it from operating with the device. Pairing mode can be recognised by the indicator light slowly flashing red and then blue. If the headset is inadvertently put into pairing mode it should be placed back onto the USB docking connector on the Tempus IC to turn the headset off; the voice call should be disconnected and re-initiated. You can check if your headset is on by pressing the talk button once. If the indicator light flashes blue then this means the unit is on. You do not need to switch the headset off; this is achieved by docking the headset back onto the Tempus IC. If you do wish to turn the headset off, press and hold the Multi-function button for 3 seconds until the LED flashes blue once and red three times. NOTE: If you turn the headset off during a call, you will not be able to receive the call again with the headset i.e. if you turn the headset back on you will not hear the call again. If the headset is turned off during a call, disconnect the call using the Tempus IC and then re-initiate the connection again following the on-screen instructions. NOTE: RDT recommends that users do not use the Multi-function button for any other purpose than turning the headset on (as described above). If you use the Multi-function button then other functions and features (as described in the Sennheiser manual) of the headset can be engaged – these may cause confusion. To adjust the volume during a call, press the “vol+” button or “vol-“ button on the headset as shown above. NOTE: If you press and hold the “vol-” button for 1 second you will mute the headset microphone. To release muting, quickly press the “vol-” button on the headset. RDT does not recommend that you use the muting function as this could cause confusion during a call. If you need to adjust the volume of the headset of the wireless headset (the wired headset has no volume controls) after you have connected the voicelink, you can get instructions on how to adjust the volume by pressing the button. This is shown the first time you go into the camera iAssist process and the first time you go into the blood pressure and pulse oximetry process after switching on. You can also access the same instructions by pressing the Headset button on the main help menu after you have connected the voicelink. Headset Help Button
Tempus IC User/Operator Manual- USA Page 47 41-1025-03A Pressing the Headset Help button will bring up an iAssist process. This contains two different steps, each of which gives instructions on addressing a different type of issue e.g. you can’t hear the response centre, they can’t hear you etc. iAssist Process for Adjusting the Sennheiser Wireless Headset’s Volume 7.3 Connection Status Indicators NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires.
Tempus IC User/Operator Manual- USA Page 48 41-1025-03A The connection status indicators show whether the Tempus IC is connected to the Response Centre. There are separate indicators for the voice link and the data link. The following symbols indicate the state of the links: Call in progress ('connected') No call in progress ('disconnected'). Note that the words 'connected' and 'disconnected' refer to whether there is a call in progress, NOT whether the Tempus IC phone wires are plugged in. 7.3.1 Dialling Order and Indicators When Dialling Once a voice or data link has been initiated, the “No call in progress” indicator will change to a “Call in progress” indicator which will start to flash. The voice and data link indicators will flash independently until each link has been connected. While waiting for the voice link to connect, the Tempus IC can be used to take measurements of the patient e.g. blood pressure, pulse oximetry and a video picture, which will then be available to the response centre as soon as the connections have been completed. 7.3.1.1 Data Dialling Once dialling has been initiated, text will appear giving a countdown to when the data link is expected to connect. This is accompanied by a blue progress bar which grows as the time to connection gets closer. Once the data link has been established the text indicator will display “Data Connected” and the “Call in progress” indicator which will stop flashing. 7.3.1.2 Voice Dialling The voice link will start to dial as soon as the data link is connected. If the data link is taking longer to connect than usual (as a result of difficulties with the communications channel) then the voice link will dial within a preset time (typically 3 minutes 40 seconds). In addition, a countdown will flash behind the “Voice Link?” status indicator to show how long it can be before the voice line will start to dial, the voice link will typically dial before the countdown is completed. Once the voice link has been established the text indicator will display “Data Connected” and the “Call in progress” indicator which will stop flashing. NOTE: If your Tempus IC has a built in Cell Phone (GSM) phone built into it, then it will need to log onto the network at the beginning of each call. This is shown by similar text and a separate progress bar for logging on.
Tempus IC User/Operator Manual- USA Page 49 41-1025-03A 7.3.1.3 Automatic Redialling If the Tempus IC is configured to redial the voice or data links automatically then it will indicate that a redial is taking place by displaying a number behind the “Call in progress” indicator. 7.3.1.4 Indicators Once Connections Have Been Established Once the voice and data links have been connected, their status indicators will stop flashing. In addition, once the data link has been established the progress bar will disappear and the following text will be displayed. 7.3.1.5 File Transfer Status Indicator When data files (either an ECG or a still digital picture) are being transmitted, the progress bar shows how far the transmission has progressed. 7.4 Communications Modes Tempus IC can connect to the Response Centre using different connection a number of wired and wireless communications interfaces e.g. Ethernet or WiFi. Connecting over wired interfaces such as Ethernet requires connecting the Tempus using a cable; connecting over wireless interfaces such as WiFi require no physical connection to be made. To switch between these types of connection, the Tempus IC is pre-set to connect using different communication “Modes”. Each Mode is supported by a full set of graphical connection iAssist help process that provide the User with instructions specific to connecting using that technology. The Tempus IC shows what Mode it is in with a banner at the top of the Connection IAssist help process. The Tempus IC will stay in this Mode until it has been set to another Mode (even if it has been turned off and on again). 7.4.1 Changing Modes You can change the Mode that the Tempus IC is set to by pressing from the Help Menu IAssist help process. This will bring up the Communications Modes Menu. NOTE: Follow the instructions provided on the Menu shows what Modes are available to use (See Section 7.4.3). 7.4.2 Using Available Modes The Modes that are available on each Tempus IC are dependent on the requirements of each User. Refer to the Modes Menu on your Tempus IC for specific details of each Mode that is available. Remember that each Mode may have a different set of instructions for connecting, fault finding and repacking. Consequently it is vital that you remember to read and follow what each iAssist help process says at all times. It is also important to remember that if one Mode cannot be used then another may be usable in its place e.g. if GSM coverage is not available then a landline connection may be useable instead.
Tempus IC User/Operator Manual- USA Page 50 41-1025-03A 7.4.3 Changing the Connection Mode To change mode, bring up the help menu and then follow the instructions below: The Modes Menu Button on the Help Menu Example of the Modes Menu If you wish to exit the Modes Menu press here. 2. Then make the relevant selection by pressing on one of the buttons shown here – CHECK the title of the mode is what you want. 1. Press the touchscreen here
Tempus IC User/Operator Manual- USA Page 51 41-1025-03A Example of the New Mode Title 3. You can confirm that the correct selection has been made by checking the title.
Tempus IC User/Operator Manual- USA Page 52 41-1025-03A 8 Taking Medical Readings NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. The Tempus IC is intended for use on one patient per incident. It must not be used on more than one patient because the Tempus IC has no way of associating a measurement with a particular patient. WARNING It is essential to switch off the Tempus IC in between different patients to avoid confusion between different patient records. 8.1 Blood Pressure and Pulse Oximeter To activate the Blood Pressure & Pulse Oximeter function, press the button on the device. The first step in the Blood Pressure & Pulse Oximeter help process will appear. Follow the instructions provided on the iAssist help process to activate Blood Pressure & Pulse Oximeter. Select the correct size blood pressure cuff from the storage compartment (the normal size adult cuff is highlighted on the Blood Pressure And Pulse Oximeter Help Screen shown on the device). The cuff must fit comfortably on the upper arm. To connect and connect the tube to a cuff, insert using a twisting motion Example of the Blood Pressure And Pulse Oximeter Help Screen
Tempus IC User/Operator Manual- USA Page 53 41-1025-03A WARNINGS The Tempus IC is not for use on neonates (young babies). The Tempus IC is not intended for long term patient monitoring. There are no audible or visible alarms. Reposition the oximeter probe at least once every 1hour to allow the patient's skin to respire. The SpO2 sensor should snugly fit the finger without straining it and if not alternative fingers should be tried. The Tempus IC will not operate effectively on patients who are experiencing convulsions or tremors. Prolonged or repetitive use of the blood pressure cuff may harm skin integrity and circulatory status. Observe the limb concerned to check that circulation is not impaired. CAUTION OneTime® nail polish remover is flammable. Keep away from heat and flame. Use adequate ventilation. Exposed pad should be placed on glass or tile surface only. FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. Notes Dyes introduced into the bloodstream, including methylene blue, indocyanine green, indigo carmine and fluorescein may cause an inability to determine accurate SpO2 readings. Any condition that restricts blood flow, such as use of a blood pressure cuff (other than the Tempus IC cuff used in accordance with the instructions herein) may cause an inability to determine accurate pulse and SpO2 readings. Compression or restriction of the blood pressure hose or cuff, or induced movement or vibration may prevent the monitor from taking a reading. SpO2 measurements may be adversely affected in the presence of high ambient light levels. If necessary, shield the sensor area (e.g. with a towel). Remove fingernail polish or false fingernails using the wipe provided before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. Performance and safety test data are available on request from the address in section 1.1. Significant levels of dysfunctional haemoglobins, such as carboxyhaemoglobin or methemoglobin will affect the accuracy of the SpO2 measurement. The graphical displays of pulse rate, SpO2 and pulse strength are not proportional to the pulse volume. The SpO2 sensor must be on the opposite arm to the blood pressure cuff. The arm of the patient must be kept still and either be horizontal to the shoulder (if the patient is laying down) or below the shoulder (if the patient is sitting upright). If the finger selected does not give good results, this could be due to poor perfusion of blood. Ensure that the finger is inserted all way into the clip, or try taking a reading on another finger.
Tempus IC User/Operator Manual- USA Page 54 41-1025-03A IMPORTANT You must use the right size of blood pressure cuff to suit the patient, and you must tell the Tempus IC if you are using the Large cuff or Child cuff. The cuffs are marked as follows: Normal adult (23 – 33 CM). Cuff is coloured BLUE. Large adult (41 – 40 CM). Cuff is coloured DARK RED. Child or small adult (12 – 18 CM). Cuff is coloured GREEN. 8.1.1 Understanding the Pulse Oximeter Results The Pulse Oximeter display has four data elements. Measurements are made continuously and updated in real time. Measurements are sent in real time to the Response Centre provided that the data link is active. The Pulse section contains a bar graph and digital display of the patient's pulse rate, in beats per minute (Bpm). • Note that extreme pulse rates above 175 Bpm or below 25 Bpm are outside the range of the bar graph display but will be shown accurately on the digital display. The SpO2 section gives the oxygen saturation of the blood, and displays the result in bar graph and digital form. • Note that extreme blood oxygen levels below 50% are outside the range of the bar graph display but will be shown on the digital display (readings below 40% are not shown). The Signal Strength bar graph shows the how well the pulse sensor is detecting the pulse. The amplitude of the indication indicates the quality of detection. If the indication on the Signal Strength meter is low, or becomes low, then the finger sensor should be repositioned. Similarly the Perfusion Index gives a numerical indication of the level of arterial pulsatile blood at the sensor site. 8.1.2 Understanding the Blood Pressure Results The Blood Pressure display has three elements plus a status indicator. The results comprise Systolic and Diastolic readings in mmHg and a timestamp in GMT. Once the BP is active (either inflating or deflating or on timer), the button will be shown next to the Cuff Status icon. Pressing this button at any time will stop the blood pressure monitor and cause the cuff to deflate immediately. The measurements are normally made every five minutes via an automatic timer. Note that when the unit is in timer mode, the Cuff Status icon will change state. The possible states of the blood pressure monitor are: • Blood pressure monitor is idle; • Cuff is inflating; • Cuff is deflating; • Cuff is on timer; • Cuff is on timer;
Tempus IC User/Operator Manual- USA Page 55 41-1025-03A • Cuff is on timer. Measurements are sent to the Response Centre every time they are made, provided that the data link is active. 8.1.3 Blood Pressure Monitor Error iAssist Help Process The Tempus IC will automatically display iAssist help process in the event that it encounters problems in taking a blood pressure measurement. The problems that it can encounter may often have a fairly simple solution, consequently, the iAssist help process attempt to guide the Operator through some basic checks that can be made. The conditions that could occur are: • The cuff or hose leaking; • Overpressure – caused by blockage or compression on the cuff; • Weak signal – caused by a poor connection to the patient, a blockage or similar; • Timeout – the Tempus IC could be detecting noise from the cuff which prevents a valid reading from being made, this could be caused by movement on the cuff or hose, vibration, patient activity etc. If the Tempus IC experiences one of these types of errors, it will provide on-screen instructions on how to check for and clear the problem. It should be understood that it can be normal to experience these types of errors when taking readings if the usage instructions have not been followed carefully. 8.2 Electrocardiograph (ECG) To activate the ECG function, press button on the device The first step in the ECG help process will appear. Follow the instructions provided on the iAssist help process to activate ECG. WARNINGS The Tempus IC should not be used on patients undergoing defibrillation. The Tempus IC is protected against defibrillator discharge but rate meters and displays may be temporarily affected during defibrillator discharge but will rapidly recover. The Tempus IC will not operate effectively on patients who are experiencing convulsions or tremors.
Tempus IC User/Operator Manual- USA Page 56 41-1025-03A Example of the ECG Help Screen CAUTIONS The electrodes of the ECG apron must be applied carefully. Care must be taken to ensure that the electrodes do not contact live (electrical) parts or earthed metal parts of local systems or structures. The ECG spray is not to be used on broken or irritated skin Note Whilst the ECG harness fits many patients, one size cannot fit all patients. Consequently, the ECG data collected may not be of diagnostic quality for some patients. The leads and cables of the ECG should be checked for fraying, tears, knots or other signs of damage before and after use. The ECG spray is not a disinfectant. If the ECG contact spray goes into a person’s eyes, it may be washed out using clean water. The ECG spray bottle is marked with a label reading “USE BY:” and then giving a date. All bottles of fluid must be discarded once this date has been reached.
Tempus IC User/Operator Manual- USA Page 57 41-1025-03A Once the iAssist process has been completed the Tempus will display the ECG. The ECG Monitoring Screen The Tempus IC is now monitoring the patient's ECG, but is not recording the information. The traces move across the screen from left to right, erasing and replacing old readings as the monitoring progresses. It takes 3-4 seconds for the trace to cross the screen. You should wait at least 30 seconds before recording the ECG. While the ECG is on the patient should sit still, relax and not talk as any of these activities can disrupt the ECG. The displayed waveforms may be partially or totally disrupted if, • The patient is moving or talking; • The harness is not connected properly; • The electrodes have not been sprayed with the contact solution or the solution has dried off; • The harness is not positioned correctly. The bottom of the screen shows the current status of the ECG settings. ECG Filter 50Hz 60Hz. This should either be set to 50Hz1 or 60Hz. ECG systems can pick up interference from mains electricity supplies. This interference appears on the screen as regular interference patterns. The filter setting is shown in the bottom left corner of the ECG. It will either show 50Hz or 60Hz as lit, pressing on this area of the touchscreen will change the setting. 8.2.1 Monitoring an ECG To record an ECG, press ‘Start Recording’ on the touch screen. Recording an ECG takes ten seconds. It is essential that the patient is relaxed and does not talk or move while an ECG is recorded. If the patient is moving then the muscle movement can produce small electrical signals (known as “artefact”) into the ECG. An ECG containing artefact (additional signals appearing on the ECG which are generated by muscle movement and not by the heart) may not be clear enough for a medical professional to make a diagnosis so it is important that the patient remains completely still during the recording. 1 Hz means Hertz, or cycles per second. In North America, mains electricity supplies operate at 60Hz; most of the rest of the world uses 50Hz. In aircraft the filter should normally be set to 50Hz. In remote land and maritime applications the local voltage could be either 50Hz or 60Hz.
Tempus IC User/Operator Manual- USA Page 58 41-1025-03A Wait for the ECG trace to stabilise (like the trace shown above), ask the patient to breath in and out and then to hold their breath for 10 seconds before pressing ‘record’ If the trace does not stabilise, check the following: • Patient should not be moving • The apron should be aligned correctly • The wrist electrodes should be on the correct sides • The hip electrode should be on the left hip • All the electrodes should be in good contact with the skin (use plenty of the spray if in doubt). If you are not satisfied with the EGC trace e.g. it is unstable on some or all of the traces, you can press the ECG Assistant button on the touchscreen. This will ask you to confirm which part of the ECG you are dissatisfied with and will then offer more detailed instructions on the application of the ECG harness based on which traces you have indicated are suspect. 8.2.2 Recording an ECG Once the recording is complete, the results will be displayed as shown in the following picture. ECG Recorded If the Tempus IC is connected to a Response Centre, it will automatically start to transfer the ECG file. At this point you can press to close the ECG view to return to the main screen or you can press ‘monitor’ on the touch screen to return to monitoring mode. Note that if you turn the ECG off at this point and then restart the ECG function later during the same incident (without switching the Tempus IC off), these results will be shown again. This means that you can view the last ECG that was recorded from the patient. CAUTION It is essential that the Tempus IC is switched off before it is connected to another patient, otherwise information from one patient (e.g. an ECG recording) may be confused with that taken from another patient. .
Tempus IC User/Operator Manual- USA Page 59 41-1025-03A 8.3 Capnometer To activate the Capnometer function, press button on the device The first step in the Capnometer help process will appear. Follow the instructions provided on the iAssist help process to activate Capnometer. Example of the Capnometer Help Screen WARNINGS The Tempus IC is not intended for long term patient monitoring. There are no audible or visible alarms. The Tempus IC is not for apnoea detection. The Tempus IC has not been tested or validated for use in apnoea detection. CAUTION Use of monitoring during continuous nebulised medication delivery will result in damage to the Tempus IC which is not covered by the warranty. Disconnect the capnometer sample line from the Tempus IC or switch off the Tempus IC during medication delivery.
Tempus IC User/Operator Manual- USA Page 60 41-1025-03A Notes The capnometer is not for use in conjunction with breathing or anaesthetic systems. 8.3.1 Understanding the Capnometer Results The Capnometer display has two elements. Measurements are made continuously and are updated in real time. Measurements are sent in real time to the Response Centre provided that the data link is active. Once the Capnometer is active, the button will be shown next to the ETCO2 results. Pressing this button at any time will stop the Capnometer immediately. The Respiration Rate section contains a bar graph and digital display of the patient's breathing rate, in respirations per minute (Rpm). • Note that extreme rates above 50Rpm are outside the range of the bar graph display but will be shown accurately on the digital display. The ETCO2 section gives the partial pressure of the exhaled CO2 at the end of the breath. This is displayed in bar graph and digital form. .
Tempus IC User/Operator Manual- USA Page 61 41-1025-03A 8.4 Thermometer To activate the thermometer, press button on the device The first instructions will be displayed. Follow the instructions provided on the iAssist help process to use the thermometer. The thermometer is the large white and green device. It connects to the Tempus IC via Bluetooth®. Example of the Temperature Help Screen Note that the thermometer function is not yet licensed for use in Canada. The Thermometer The display, shows the unit is on and what the reading is and indicates errors The ON/MEM button. Press once to turn on, press and hold to turn off. The measurement button, press and hold for 1 second to take a reading The battery cover, slide it away to replace the battery
Tempus IC User/Operator Manual- USA Page 62 41-1025-03A CAUTION The thermometer provides fast, accurate temperature measurements on any patient into which its probe can be inserted into the ear canal to view the tympanic membrane. It can be considered for use on any patient above three (3) years of age. Do not use the thermometer if the probe cannot be inserted into the ear canal. Keep the probe covers and connection ring away from children. The thermometer should always be used with a probe cover attached. Probe covers should be replaced between each measurement. Notes Improper installation of the probe cover may cause inaccurate measurements, ensure the probe cover is fitted correctly and a new probe cover is fitted for each measurement. Allow the thermometer and the patient to acclimatise to the same ambient temperature before taking temperature readings. Dirt, greasy films or moisture on the thermometer lens may affect the accuracy of the instrument. Deposits of cerumen (ear wax) can affect the measurement. Do not open the thermometer case. The thermometer will require factory recalibration if the case is opened. Place the smooth side (not the adhesive side) of the probe cover to the connection ring. The device should be checked for damage if it has been dropped. Holding the thermometer too long may cause a higher ambient temperature reading of the probe. This could make the body temperature measurement lower than usual. Do not press the thermometer button until instructed by the steps shown on the screen as the device will not operate. The thermometer’s sensor requires a few seconds to stabilise at the measurement site before a reading can be taken. If the measurement button is pressed too quickly after the thermometer is inserted into the ear, the device may not be able to take a reading. In this event it will emit a “double-beep” and flash a symbol on its display (see section 10.3.2). In this event, place the thermometer back into the patient’s ear (as per instructions), wait 6 seconds and then take the reading. The thermometer is switched on and off using the “ON/MEM” button. Press the button briefly once (when instructed by the on-screen instructions) to turn the thermometer on. It will automatically try to communicate with the Tempus IC over the Bluetooth® link. Press and hold the ON/MEM button for 3 seconds to turn it off. Note that to extend the battery life the thermometer will automatically shut off if left idle for more than 1 minute. Note that the thermometer has a memory of the last 10 readings it has taken. These will be shown on the thermometer’s display (but not transmitted to the Tempus IC) if the ON/MEM button is pressed after the device has been turned on e.g. if the button is pressed once it will show the most recent reading (preceded by a “1”), if pressed twice it will show the reading taken before that (preceded by a “2”) and so on. For this reason it is recommended that the ON/MEM button is not pressed and also that the thermometer display is not reviewed while obtaining temperature readings. The thermometer is normally supplied set to read in Centigrade (ºC). If required, it can be changed over to read in Fahrenheit (ºF). If the user wishes to switch the units that the thermometer itself displays, this can be achieved by pressing and holding the measurement button whilst turning the thermometer on. If the user wishes to switch the units that the Tempus displays see section 12
Tempus IC User/Operator Manual- USA Page 63 41-1025-03A Only use non-rechargeable batteries with the thermometer. Do not attempt to use, swap or pair the thermometer with other Tempus IC units or other devices. Consult RDT if you need replacement thermometers. Users must ensure the thermometer that is paired with the Tempus remains with it. Unpaired thermometers will not work when required unless they are first paired with the device. Users are reminded to ONLY use the thermometer within the range specified in section 13.1.5. Due to its nature Bluetooth technology is wireless and therefore results may not be received 100% of the time. Risk factors for example would include the user moving out of range during the measurement or environmental factors e.g. building materials and construction design reducing operational effectiveness. Users should note that if a reading is not received they should repeat the process, if possible this should be done closer to the Tempus IC. Users should note that while the Bluetooth technology will operate in environments where other Bluetooth devices are in use, operation can be affected if the number of other devices becomes very high (e.g. there can be high densities of devices at trade shows). If issues with a Bluetooth connection are experienced then the measurement should be attempted again either in a different environment (with less Bluetooth devices turned on locally) or closer to the product. 8.4.1 Using the Thermometer When following the on-screen instructions, attention should be paid to the signals given out by the thermometer. If measurements are taken incorrectly (too quickly, at the wrong measurement site etc.) then the thermometer’s display will show an error. Errors are discussed in section 10.3. It should be noted that once the thermometer is turned on it will power itself off after 1 minute if no buttons are pressed, therefore the onscreen instructions should be followed promptly after the thermometer has been turned on. It is recommended that 3 measurements are taken from the same ear and the highest of the three used. 8.4.2 Understanding the Thermometer Results When measurements are made, they are time stamped and sent to the Response Centre provided that the data link is active. The clinical repeatability of the thermometer is 0.23°C (<1 year old), 0.22°C (1~5 years old), 0.21°C (>5 years old). It should be noted that normal temperature variation in healthy patients can be between 0.2-1°C across different parts of the body
Tempus IC User/Operator Manual- USA Page 64 41-1025-03A 8.5 Glucometer 8.5.1 MyGlucoHealth Glucometer To activate the Glucometer function, press button on the device The first Glucometer help screen will appear. Follow the instructions provided on the iAssist help process to activate the Glucometer. Example of the MyGlucoHealth Glucometer Help Screen If the timestamp, received alongside the blood glucose reading, is more than ±1 hour out from the current Tempus time, a warning shall be displayed to the user. This warning gives the user the option of taking another reading in order to correct the time stamp. See section 8.5.1.1 for details on how to set the clock on the glucometer. At altitude the blood sugar level reading will be slightly lower than that at ground level but within the stated accuracy of the glucometer. WARNING The MyGlucoHealth meter is provided pre-set to provide results in mg/dl format ONLY. The results shown on the Tempus IC will be in mg/dl format for users based in the USA and in mmol/l format in all other areas. Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemix-hypersmolar state, with or without ketosis. Critically ill patients should not be tested with blood glucose meters.
Tempus IC User/Operator Manual- USA Page 65 41-1025-03A CAUTIONS Do not store the glucometer strips outside of the stated environmental limits and ensure their shelf life information is heeded. Ensure that the instructions for use attached to the strips are heeded. Only MyGlucoHealth test strips are to be used with the MyGlucoHealth glucometer Use fresh capillary whole blood only when taking measurements. Dehydration may lower test results. Glucometer Notes This glucometer, used with the Tempus IC, is the MyGlucoHealth® meter made by Entra Health Systems PTY. Ltd of Australia. The Tempus IC uses the MyGlucoHealth® meter as it is intended i.e. to measure a patient’s blood glucose and to transmit this over Bluetooth® to a second device (the Tempus IC) for re-transmission. The only difference is that the measured result is forwarded to the response centre that receives the Tempus IC call rather than the MyGlucoHealth® web portal. The MyGlucoHealth® meter measures the patient’s blood glucose levels and transmits them wirelessly (over Bluetooth®) to the Tempus IC. The user manual for the MyGlucoHealth® meter is provided on the same CD-ROM as this manual. While applicable extracts of the MyGlucoHealth® manual are reproduced in this manual, Users should also read the manual of the MyGlucoHealth® meter to ensure they have familiarised themselves with the device. Do not attempt to use, swap or pair the glucometer with other Tempus IC units or other devices. Consult RDT if you need replacement glucometers. Users are reminded to ONLY use the glucometer within the range specified in section 13.1.6. Due to its nature Bluetooth technology is wireless and therefore results may not be received 100% of the time. Risk factors for example would include the user moving out of range during the measurement or environmental factors e.g. building materials and construction design reducing operational effectiveness. Users should note that if a reading is not received they should repeat the process, if possible this should be done closer to the Tempus IC. Users should note that while the Bluetooth technology will operate in environments where other Bluetooth devices are in use, operation can be affected if the number of other devices becomes very high (e.g. there can be high densities of devices at trade shows). If issues with a Bluetooth connection are experienced then the measurement should be attempted again either in a different environment (with less Bluetooth devices turned on locally) or closer to the product. If the Tempus displays a reading of HIGH or LOW from the glucometer then this corresponds to a value of >599.4mg/dl or <10.8mg/dl respectively. The glucometer is accurate provided that testing areas are clean and dry and contain no foreign substances such as lotions or creams. The glucometer has a memory of the last 250 readings it has taken. These will be shown on the thermometer’s display (but not transmitted to the Tempus IC) if the CENTER/POWER button is briefly pressed. The newest data appears first and the up and down buttons used to scroll through the list. For this reason it is recommended to avoid pressing the CENTER/POWER button, unless when instructed to do so during the measurement process.
Tempus IC User/Operator Manual- USA Page 66 41-1025-03A Lancet Notes For use with the glucometer, RDT supplies the “SAFE Press” sterile safety lancets manufactured by Vitrex Medical A/S of Denmark. These are single use devices which are supplied sterile and are labelled accordingly. Users should follow the on-screen instructions for using, discarding and repacking the glucometer as these include the relevant information on the use of the lancets. Users should not use lancets if the protective cap has been removed. 8.5.1.1 Setting the Clock on the MyGlucoHealth Glucometer The date and time on the glucometer must be the same as the date and time set on the Tempus IC (± 1 hour) in order for the Tempus to be sure the correct measurement value has been received from the glucometer. To set the date and time follow these steps NOTE: The Tempus IC time is always set to GMT (Greenwich Mean Time) Step 1: Press and hold the CENTER/POWER button on the Glucometer for at least 3 seconds until the ‘year’ starts flashing. Step 2: Press either the UP or DOWN button to set the current year. Press the CENTER/POWER button. The month (MON) will now be flashing. Step 3: Use either the UP or DOWN button to set the values for the month, day, hours, and minutes using the CENTER/POWER button to move to the next value to be set. Step 4: Then Press and hold the CENTER/POWER button for at least 3 seconds to exit the process. 8.5.1.2 Testing the Glucometer The MyGlucoHealth® meter can be tested by going through a measurement, following the Tempus IC onscreen instructions and then applying the control solution in place of blood. See the MyGlucoHealth® manual, section entitled ‘Checking The System With The MyGlucoHealth Control Solution’, for details. NOTE: Do not use the control solution if expired 8.5.1.3 Understanding the Glucometer Results When measurements are made, they are time stamped and sent to the Response Centre provided that the data link is active. 8.5.1.4 MyGlucoHealth Regulatory Approvals Council Directive 98/79/EC In Vitro Diagnostic Directive. ISO 15197:2003 In vitro diagnostic test systems – Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15223:2002 Medical devices-Symbols to be used with medical device Labels, labeling and information to be supplied. ISO 14971 :2003 Medical devices – Application of risk management to medical devices. EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use; General
Tempus IC User/Operator Manual- USA Page 67 41-1025-03A IEC 61010-2-101:2001 Safety requirements for electrical equipment for measurement, control and laboratory use; Particular IEC 61000-4-2:2001 Electrostatic discharge immunity test EC 61000-4-3:2006 Radiated, radio-frequency, electromagnetic field immunity test IEC 61326:2002 Electrical equipment for measurement, control and laboratory use EN 60068-2-64:1 994 Environmental testing EN 13640:2002 Stability testing of in vitro diagnostic reagents EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-Testing EN 1658:1996 Requirements for marking of in vitro diagnostic instruments EN 12376:1999 Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology EN 13532:2002 General requirements for in vitro diagnostic medical devices for self- testing IS0 17511:2003 Measurement of quantities in biological samples-Metrological traceability of values assigned to calibrators and control materials EN 13612:2002 EN 980:1999 EN 980:2003 EN 12286:1999 Performance evaluation of in vitro diagnostic reagents Graphical symbols for use in the labeling of medical devices Graphical symbols for use in the labeling of medical devices EN1 2287:1999 Measurement of quantities in samples of biological origin- Presentation of reference measurement procedures Measurement of quantities in samples of biological origin- Description of reference materials
Tempus IC User/Operator Manual- USA Page 68 41-1025-03A 8.6 Digital Camera When requested by the Response Centre, it is possible to capture and send still digital pictures using the camera built into the device. Digital pictures are shown live on the Tempus IC screen so that you can see what the camera is seeing. When you are happy with the displayed image, you capture the picture and can then send it to the Response Centre (if you are not connected the image will be stored for transmission later). To activate the Camera, press button on the device The first Camera help screen will appear. A digital picture from the camera will appear on the Tempus IC display in the position shown in the following picture. Follow the instructions provided on the iAssist help process to take a photo. Example of the Tempus IC Display Showing Location of Digital picture NOTE: The Tempus IC will go into the camera process as soon as the voice connection has started dialling.
Tempus IC User/Operator Manual- USA Page 69 41-1025-03A Example of the Tempus IC Display Showing Photo Image Aim the camera so that you get the picture you need on the screen (e.g. a close-up of the patient). When you are happy that the displayed image shows what you want, press on the touch screen to freeze the image. A countdown will appear on the screen before the picture is sent. To discard the image during the countdown and take another picture, press , otherwise the picture will be sent when the countdown reaches zero.
Tempus IC User/Operator Manual- USA Page 70 41-1025-03A If you are connected over either an Ethernet or WiFi link, it will be possible to send moving video to the Response Centre. This can be done in two ways: • Press the “Transmit Video” button. The “Camera and Video Options” dialog will stay on the screen and the Response Centre will see what you see in the viewfinder window on the left hand side of the dialog. Example of the Tempus IC Transmitting Video • Press the “Transmit Video in Background” button. The “Camera and Video Options” dialog will disappear from the screen; you will be able to see that video is being transmitted because a video icon will appear at the top of the screen. This feature is intended to allow users to transmit video while using other features of the device. Users should note that when the Tempus IC has its foot deployed, the angle of the camera should enable them to frame a patient without the need to hold the Tempus in position. Video Icon NOTE: Moving video is intended to give the Response Centre the ability to see the patient moving or to see around the patient’s environment. Users should remember that the resolution and quality of the received video stream will not be the same as they see on the screen of the Tempus IC due to the effects of the video being compressed during transmission. This effect is lessened when the image being filmed is more stable or has less activity in it. Therefore in order to ensure the received video is good quality, Users should try to move the camera slowly. If rapid movement of the camera is necessary then the received image is likely to be have a temporarily lower level of resolution (will appear “blocky”) while the camera is being moved around, this effect will reduce once the camera movement is reduced.
Tempus IC User/Operator Manual- USA Page 71 41-1025-03A NOTE: The overall image quality and resolution of the camera is greater for still pictures than moving video. If the Response Centre require an image with a reasonable level of detail (such as a close-up image) then a still photo would probably be more suitable. 8.6.1 Annotation of Digital pictures Images transmitted from the Tempus IC can be altered using the software at the Response Centre. The altered image can then be sent back to the Tempus IC to act as a support in the remote diagnostic procedure i.e. the physician can send pictures back that can be used to confirm exactly the issue being examined or discussed, thus avoiding the danger of misunderstanding verbal descriptions. Images can be amended using the following tools:  Zooming in and out  Addition of text  Addition of circles  Addition of lines and arrows  Addition of free-form lines  Selection of colours for added graphics 8.7 Interacting with the Response Centre 8.7.1 The Response Centre Although the Tempus IC may be used without connection to a Response Centre (i.e. if there is a physician locally or if the unit is being used to collect data for later transmission), in most incidents it is likely that a Response Centre will be contacted as the first priority after having activated the device. Each Tempus IC device is pre-configured to dial automatically to a specific Response Centre. The centre should be staffed 24 hours a day, 365 days a year and be always able waiting to receive your connection. If a connection cannot be established, you should wait a short time and attempt to connect again. The Tempus IC is designed to allow maximum ease of use for the operator (even extending to partial remote control by the Response Centre if necessary) and also to transmit the medical data to the Response Centre. It is the function of the Response Centre staff to help control the situation, make an assessment based on the data received and to offer advice on the appropriate steps to take. When interacting with the Response Centre staff, please carry out all of their instructions to the best of your ability. If anything is not obvious, do not hesitate to ask for clarification or further guidance. Most incidents will begin with the Response Centre staff asking questions relating to the nature of the incident. These questions may include such areas as: • Nature of the patient e.g. name, sex, age, doctor’s details • Nature of the problem e.g. perceived symptoms, known history (has the patient been monitored using the Tempus IC before) • Nature of the incident e.g. where the incident is taking place, who is responsible for the remote location When interacting with the Response centre staff, you should also realise that they will almost always be operating in a different time zone to the one where the incident is taking place. However, the time of the both the Tempus IC and the Tempus Monitoring Station (the Response Centre hardware) are pre-set to operate on GMT (Greenwich Mean Time).
Tempus IC User/Operator Manual- USA Page 72 41-1025-03A NOTE: If informed by the Response Centre staff that the results or video have stopped appearing on the Response Centre, stop the connection and reconnect the Tempus. 8.7.2 Remote Viewing and Control The Response Centre operators will have exactly the same information on their screens as those displayed on the Tempus IC. Should the Tempus IC display change e.g. if a new help screen is brought up, new data is displayed or an error message appears, the Response Centre system will display exactly the same information a few seconds later. The only exceptions to this are when you are taking a digital picture or when you are monitoring or recording an ECG, in these situations the Response Centre only see that you are in the process of recording the ECG or taking the photo but they don’t see the ECG or photo until its has been downloaded. Since the Response Centre can see what you see on the device, and since they can control it remotely, if you are experiencing problems using the Tempus IC, they can guide and support you in its use. If the Response Centre need to operate the Tempus IC remotely, they should make you aware that they are activating a function of the device before they do so. Ideally the Response Centre will only take control of the Tempus IC if the operator is having difficulty with an operation. 8.8 Recording Data Off-line and Transmitting On-line NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. Although the Tempus IC is generally intended to be used whilst connected from the remote location to a Response Centre, the Tempus IC can also be used without the telecoms connection having been made. All the functions of the Tempus IC operate normally if the telecoms connections are not made and data can be taken from a patient using all of the medical devices that the Tempus IC provides. Naturally, if a connection has not been established, no data or photographs can be transmitted and there will be no voice connection to the Response Centre operator. However, if the Tempus IC is used on a patient without a connection being made, the data is stored and automatically transmitted once the device is connected. If the device is turned off before it is connected the data will not be saved.
Tempus IC User/Operator Manual- USA Page 73 41-1025-03A 8.9 GPS Location The Tempus IC has a built-in GPS receiver. You can access this feature from the Help menu. The GPS Button Having pressed the GPS button, you will be shown a graphic instructing you to use the feature when outside with a clear view of the sky. GPS Help Instruction NOTE: The GPS operation will be limited if the Tempus IC is not used outside with a clear view of the sky. NOTE: The GPS is intended to provide the User and Response Centre with the patient’s location. It should not be used as a guidance or navigation device. NOTE: The Tempus IC will be supplied with the GPS enabled in non-aviation modes and enabled in all other modes. To turn the GPS receiver on or off, refer to section 12.
Tempus IC User/Operator Manual- USA Page 74 41-1025-03A GPS Fix Obtained The GPS may take up to 2 minutes to display a fix. If it unable to obtain a fix (if the view of the sky is obstructed or if the unit is used indoors) then it will display an error. The most recent fix (with the time and date of the fix) is always displayed. If the signal from only a limited number of GPS positioning satellites can be received by the Tempus (e.g. because of partial blocking of the sky by objects, buildings etc.) then the fix may be less accurate. In this case the fix will be labelled “Approximate fix” and the reading may be +/-2.5km. 8.10 Actions after Use – Turning the Tempus IC Off Before switching the Tempus IC off, you should make sure that it is not in use. Make sure that the voice and data links are not in use and that the device is not being used to monitor a patient off-line. Press the On/Off switch . The system will then bring up the dialog shown below and give a 10 second countdown. The lamp on the On/Off button will change from solid green to flashing orange. When shutting down, the Tempus IC will show dialog containing a countdown timer from ten seconds. The dialog reminds you to clean and repack Tempus IC using the icon provided. Option A: Press to stop the countdown and bring up the Instrument readings and results screen. Option B: Press to stop the countdown and bring up the Cleaning & Repacking Menu iAssist help process. Option C: Let the unit shutdown.
Tempus IC User/Operator Manual- USA Page 75 41-1025-03A Example of the Shutdown Screen 8.10.1 Logging Maintenance Requirements If consumable items such as the repack kit or a cannula have been used, the Tempus IC will alert you to the need to report the need for these items to be replaced. This alert will be provided after the shut down has been initiated. In addition to flagging the need for certain consumable items to be replaced, the alert will also inform you if: • batteries are depleted; • if specific errors have occurred; • or if a software update is required. You should use the information displayed to log or report that the Tempus IC requires your maintenance staff to provide indicated items. NOTE: This feature DOES NOT indicate that the Tempus has developed a fault. This feature is to help remind users to report that basic consumable items or maintenance activities are required. Users should not report the information displayed by this feature as a fault to RDT. Example of the Shutdown Screen
Tempus IC User/Operator Manual- USA Page 76 41-1025-03A In the example above, the Tempus IC is indicating that the battery is now below 25% charge. RDT recommends that users respond to the information posted to ensure that the Tempus IC is maintained in good working order. The potential conditions that can be logged are: Text Condition Battery charge below 70% The battery charge is below 70% of its potential full capacity Battery charge below 50% The battery charge is below 50% of its potential full capacity Battery charge below 25% Or < 25% Repack kit required If “Final Check” process was completed using the “Yes” daughter process Capnometer cannula required If Capnometer was started during the incident Glucometer repack kit required If the glucometer repack process was followed Thermometer battery required If the thermometer battery low error was reported during incident Glucometer battery required If the glucometer battery low was reported during incident Software update required If software update was notified during incident* Device fault reported If any device was disabled due to a fault Glucometer clock needs to be checked if the most recent glucometer reading time from the MyGlucoHealth glucometer was more than 1 hour different from the time the Tempus is set to *If a software update is required you should refer to your maintenance manual for instructions on how to perform this process. If one of these messages occurs during shutdown, the shutdown process will be paused until the message is confirmed. If the confirm button is not pressed and the message left on the screen, the shutdown will continue after 15 minutes.
Tempus IC User/Operator Manual- USA Page 77 41-1025-03A 9 After Using the Tempus IC NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. 9.1 Cleaning the Tempus IC It is necessary to clean the Tempus IC after use. The screen may be cleaned using a proprietary screen cleaning wipe of the type used for other LCD screens. Under no circumstances should any abrasive substance be applied to the screen. The Tempus IC instruments must be cleaned during the re-packing process. If the Tempus IC is dirty it should be cleaned with to remove any cosmetic contamination. It should be wiped down with a soft cloth, which may optionally be dampened with water and a mild detergent solution. The screen may be cleaned using a proprietary screen cleaning wipe of the type used for other LCD screens. Under no circumstances should any abrasive substance be applied to the screen. The outer case of the Tempus IC should be cleaned to remove any cosmetic contamination. It should be wiped down with a soft cloth, which may optionally be dampened with water and a mild detergent solution. 9.1.1 Cleaning the Thermometer The probe is the most delicate part of the thermometer. It should be used with care when cleaning the lens to avoid damage. Keep the unit dry and away from any liquids and direct sunlight. The thermometer should not be submerged into liquids. If the thermometer is accidentally used without a probe cover, clean the probe as follows: 1. Use a cotton swab dosed with the Alcohol (70% concentration) to clean the lens on the end of the thermometer. 2. Allow the probe to fully dry for at least 1 minute before using it. 9.1.2 Cleaning the Glucometer If the Myglucohealth glucometer is used according to its instructions, only minor cleaning is necessary. For best results perform the following: 1. Use a soft cloth or tissue soaked with a small amount of rubbing alcohol for cleaning the entire instrument. Do not use chemical solutions such as benzol or acetone and do not soak the meter or test strips in water or liquid. 2. After maintenance check the meter with control solution to ensure that it is functioning properly and then ensure the meter is completely dry before re-packing. 9.2 Cleaning and Re-packing Help Screen The user can get help at any time by pressing the button at any time. This will bring up the Help Menu. There are multiple sequential menus covering different aspects of using the device When the first Help Menu is on the screen, the next menu (Cleaning and Repacking Menu) can be accessed by pressing the Next touchscreen button.
Tempus IC User/Operator Manual- USA Page 78 41-1025-03A WARNING: The fluid contained within the wipes will cause temporary damage to the eye. In the event of contact to the eye, wash thoroughly with water for 15 minutes. Wash hands with soap and water after use WARNING: Keep wipes away from open flame NOTE: Wiped surfaces must be left wet for at least 1 minute. NOTE: Wipes are not to be used as baby wipes. NOTE: The wipes are not to be used to disinfect surfaces that have been soiled with internal bodily fluids (other than sweat). If such soiling has occurred, the item should not be used and should be returned to RDT. Example of the Help Menu The user can press any one of the following icons on the touch screen to get help cleaning and repacking the device. Example of the Cleaning and Repacking Menu The user can move backwards and forwards through the iAssist help processes by pressing the Next and Previous touchscreen buttons. It is important that you follow all the applicable repacking steps starting with ECG Harness, through to the Pulse Oximeter repack process, then following with the Connection Cables and finishing with Final Check. It is important that you always perform the Final Check process. From the Help Menu, press the Next button to bring up the Cleaning and Repacking Menu
Tempus IC User/Operator Manual- USA Page 79 41-1025-03A Suitable cleaning wipes labelled "Alcowipe" are provided within the Tempus IC. The help screen shows the location of the wipes and the user must follow the instructions provided on the iAssist help process to clean and repack the device. 9.3 Single-Use Devices The following accessories are single-use devices and must be discarded after use. No particular precautions are required when disposing of these items provided that they are not contaminated with bodily fluids. In case of such contamination, the items should be disposed of in accordance with local regulations. Part Description: • AlcoWipes • Nail Varnish Wipes • Capnometer cannulae • Glucometer strips • Lancets • Gloves
Tempus IC User/Operator Manual- USA Page 80 41-1025-03A 10 Maintenance, Servicing and Troubleshooting 10.1 General The Tempus IC is designed to be as maintenance-free as possible. The only user-replaceable and user-serviceable parts in the Tempus IC are those listed in this section of the manual. More details on maintenance are given in the Tempus IC Maintenance Manual pn. 41-1002 which is supplied on the same CD-ROM as this manual. NOTE: If the Tempus IC is no longer serviceable and is beyond repair, it may be scrapped. Scrapping the device and its accessories must be performed in compliance with applicable local regulations. It should be noted that special conditions may apply to the rechargeable battery if it is required to be scrapped. The battery should be discharged before scrapping and should not be crushed or incinerated. 10.2 Battery Management 10.2.1 The Battery The Tempus IC contains a removable, rechargeable battery. Example of the Battery Front
Tempus IC User/Operator Manual- USA Page 81 41-1025-03A Example of the Battery Rear In normal usage, the rechargeable battery provides power for at least 7 hours' continuous* use when fully charged. Every battery is provided with an integral battery life indicator which is also visible through the front panel of the case. The battery life should be monitored periodically over time when the device is in storage and also before and after use. NOTE: RDT recommends that the battery charge status should be checked once a year and recharged if necessary. RDT also recommends that the battery be completely discharged and recharged once a year. NOTE: The User should remember that battery life of older batteries will not be the same as new batteries. By monitoring the remaining battery life, situations where the battery is too weak to power the Tempus IC for the duration of an incident can be avoided. If the battery strength indicator shows less than 25% power remaining, you should change the battery if possible to ensure that there is adequate power for the next time it is needed. Using the battery down to the point where it is completely empty will not cause any hazards or damage to the system. *Assessment of use is based on projections of reasonable device usage within a patient incident made by RDT.
Tempus IC User/Operator Manual- USA Page 82 41-1025-03A 10.2.1.1 Checking the Charge of the Battery Example of the Battery Life Indicator Showing Full Charge The charge state of the battery can be obtained by pressing the button on the front. The battery is provided with 4 charge state LEDs. Pressing the button will light one or more lights. Each light corresponds to 25% of the charge state of the battery in the order (from highest to lowest):  Green – 76-100%  Green – 51-75%  Amber – 26-50%  Red – 1-25% NOTE: If the red light is flashing the battery has 10% or less charge remaining. These will light cumulatively when the battery button is pressed i.e. only the red light will light if the charge state is 1-25% after which the amber light will light as well. The charge state of the battery can be checked while the Tempus IC is in its storage Bag. Example of the Tempus IC Bag Pressing the battery button behind the window will light one to four coloured lights. Window to check the battery
Tempus IC User/Operator Manual- USA Page 83 41-1025-03A The Tempus IC does not need to be removed or turned on to check the battery. 10.2.2 Removing the Battery from the Tempus IC To replace the battery: 1 First check the replacement battery has sufficient charge by checking its indicator. Example of the Battery Indicator 2 Next, ensure the Tempus is switched off. Then remove the battery by squeezing the two latches inwards, then pull the battery away. WARNING: Do not short-circuit the terminals of any battery. A short circuit can occur if the battery terminals come into contact with any metal or other electrically conductive object. The battery may be irreversibly damaged if it is short-circuited. NOTE: Before removing the battery you must switch off the Tempus IC by pressing the power button. NOTE: Remember that the battery cannot be removed until the red lamp on the front panel has gone out. 3 Slide the new battery all the way into the Tempus until it clicks into place on both sides.
Tempus IC User/Operator Manual- USA Page 84 41-1025-03A Fitting the Battery WARNING: Ensure the latches on both sides of the battery are fully engaged prior to using the Tempus - an incorrectly fitted battery could result in the Tempus loosing power during use. 10.2.3 Charging the Battery The battery can be charged either when it is fitted to the Tempus IC or when it is removed from the separate battery charger. WARNING: Do not attempt to charge the battery using any charger other than those supplied by RDT. 10.2.3.1 Charging the Battery when Attached to the Tempus IC 1. When fitted to the Tempus IC, the battery can be charged by connecting the power supply (part number 01-1017) to the 3 pin connector on the right hand side of the Tempus. The PSU Plug Attached to the Tempus IC Connector 2. When the power supply is attached to the Tempus IC, the green power light on the Tempus IC front panel will turn on. 3. If a battery is attached the green charge light will flash. The lights on the battery will light solidly up to the charge state of the battery at the time.
Tempus IC User/Operator Manual- USA Page 85 41-1025-03A The Power Light and the Charge Light NOTE: Power supply is rated 110-240V 50-60Hz 1.5A. NOTE: Charge times of the battery will vary depending on the how the Tempus IC is being used. If the Tempus is switched off charging will be faster than if the Tempus is on and all features are being used. NOTE: Charging a completely empty battery will take 6 hours when the Tempus IC is switched off. 10.2.3.2 Using the Battery Charger When the battery is separate from the Tempus IC, the battery may be charged by connecting it to the battery charger (part number 01-1012). To attach the charger to the battery, the clip must be firmly pressed onto the connections of the battery. Note that the clip of the charger can only be connected to the battery in one way. The Battery Connector Attached to the Battery 1. Clip the charger to the battery (the clip only attaches in one way). 2. Attach the charger to the main supply. 3. The charger’s LED will light orange (for approximately 0-85% charge), change to yellow during charging (at approximately 86-100% charge) and will turn green when finished. If the battery is only partially discharged then the LED may start on yellow. NOTE: Battery charger is rated at 100-240V 50-60Hz 0.9A. NOTE: Recharging the battery takes up to 6 hours for a fully discharged battery. Battery Charge Light Power Light
Tempus IC User/Operator Manual- USA Page 86 41-1025-03A 10.2.4 Tempus IC Battery Shelf Life 10.2.4.1 Shelf Life of Batteries Stored as Spares A new and fully charged battery retains approximately 80% of its charge after 12 months in storage detached from the Tempus IC. This equates to approximately 51/2 hours of use. NOTE: RDT recommends that the battery is topped up annually. NOTE: Specifications for the battery are based on a new, fully charged battery. Shelf life ratings are based on new, fully charged packs which are stored separately from the device at 20°C. Shelf life performance will decrease over time and will be lower if the battery is stored in higher or lower ambient temperatures. NOTE: The specifications quoted for the battery relate to batteries marked “Made in the UK” and also “64.4Wh”. Shipment of these batteries began in April 2011. The performance specification of older batteries is available from RDT on request. 10.2.4.2 Shelf Life of Batteries Stored in the Tempus IC A new and fully charged battery retains approximately 70% of its charge after 12 months in storage attached to the Tempus IC. This equates to approximately 5 hours of use. NOTE: RDT recommends that the battery is topped up annually. NOTE: Specifications for the battery are based on a new, fully charged battery. Shelf life ratings are based on new, fully charged packs which are stored separately from the device at 20°C. Shelf life performance will decrease over time and will be lower if the battery is stored in higher or lower ambient temperatures. NOTE: The specifications quoted for the battery relate to batteries marked “Made in the UK” and also “64.4Wh”. Shipment of these batteries began in April 2011. The performance specification of older batteries is available from RDT on request. 10.2.5 Other Tempus IC Batteries 10.2.5.1 Bluetrek Wireless Headset Battery The headset contains a rechargeable battery. The battery of the headset is not user-replaceable and does not require user intervention. In the unlikely event that the headset’s battery becomes completely exhausted and can no longer hold charge, a replacement headset can be purchased. 10.2.5.1.1 Charging the Bluetrek Wireless Headset RDT do not supply a separate charger for the headset. The charger is built into the Tempus IC. You must follow the repacking instructions provided by the Tempus IC on screen. These will instruct you to clean the headset after use and to replace it on its docking pin before shutting down. If you do not replace the headset then the Tempus will show an error advising that the headset should be refitted. Placing the headset onto the docking pin enables the Tempus IC to recharge it. The Tempus IC recharges the headset for up to 4 hours 30 minutes (approx.) every time the headset is replaced. The charging cycle will continue regardless if the Tempus IC is switched on or off. Charging is started as soon as the headset is fitted to the docking pin. The indicator light on the headset will light red for the duration of the charging process although it may switch off intermittently for 8 second periods (this is part of the charging process). The indicator light will go off when charging is complete – which could be less than the 4 hour 30 minute maximum cycle time depending on how depleted the headset battery is. In addition, the Tempus IC will top up the charge of the headset approximately every 97 days. This occurs when the Tempus is switched off and lasts for up to 4 hours 30 minutes (approx.).
Tempus IC User/Operator Manual- USA Page 87 41-1025-03A The Tempus IC will not recharge the headset battery if the main battery is nearly empty (less than 5% charge). Caution: Do not attempt to charge the headset using any other charging device. This will automatically suspend the warranty and could be dangerous. Note: The headset has a life of up to 500 charge cycles. 10.2.5.1.2 General Guidelines for Safe Use for the Bluetrek Wireless Headset • Do not drop or try to alter the shape of your headset. • Do not expose the headset to liquid or moisture. Unlike the Tempus, the headset has no protection against ingress of solids or liquids. • Do not expose your headset to extreme temperatures. The temperature range of the headset is 0°C to 40 °C. • Do not try to disassembly your headset. Service and Maintenance can only be performed by RDT. • Do not let children play with the headset since it contains small parts that could become detached and create a choking hazard. CAUTION: Danger of explosion if battery is incorrectly replaced. Do not attempt to repair or replace the battery. If the battery is worn out a new headset is required from RDT. Dispose of the headset in accordance with local regulations. Do not dispose as household waste. The user manual for the Bluetrek® G3 headset is supplied on the same CD-ROM as this manual. Details from that manual have been reproduced in this section courtesy of Bluetrek®. 10.2.5.2 Sennheiser VMX 200 Wireless Headset Battery The headset contains a rechargeable battery. The battery of the headset is not user-replaceable and does not require user intervention. In the unlikely event that the headset’s battery becomes completely exhausted and can no longer hold charge, a replacement headset can be purchased. 10.2.5.2.1 Charging the Sennheiser VMX 200 Wireless Headset RDT do not supply a separate charger for the headset. The charger is built into the Tempus IC. You must follow the repacking instructions provided by the Tempus IC on screen. These will instruct you to clean the headset after use and to replace it on its docking pin before shutting down. If you do not replace the headset then the Tempus IC will show an error advising that the headset should be refitted. Placing the headset onto the USB docking connector enables the Tempus IC to recharge it. The Tempus IC recharges the headset for up to 4 hours 30 minutes (approx.) every time the headset is replaced. The charging cycle will continue regardless if the Tempus IC is switched on or off. Charging is started as soon as the headset is fitted to the USB docking connector. The indicator light on the headset will light red for the first 2 hours of charging and then flash blue every 5 seconds for the remaining charging process although it may switch off intermittently for 8 second periods (this is part of the charging process). The indicator lights will go off when charge cycle is complete after 4 hours 30 minutes (approx.). In addition, the Tempus IC will top up the charge of the headset approximately every 48 days. This occurs when the Tempus IC is switched off and lasts for up to 4 hours 30 minutes (approx.). Caution: Always maintain a level of at least 10% in the Tempus IC battery. Leaving the Tempus IC battery in a low charge state can risk it being depleted by the headset charging process.
Tempus IC User/Operator Manual- USA Page 88 41-1025-03A Caution: Do not attempt to charge the headset using any other charging device. This will automatically suspend the warranty and could be dangerous. 10.2.5.2.2 General Guidelines for Safe Use of the Sennheiser VMX 200 Wireless Headset • Do not drop or try to alter the shape of your headset. • Do not expose the headset to liquid or moisture. Unlike the Tempus IC, the headset has no protection against ingress of solids or liquids. • Do not expose your headset to extreme temperatures. The temperature range of the headset is 10°C to 40 °C. • Do not try to disassembly your headset. Service and Maintenance can only be performed by RDT. • Do not let children play with the headset since it contains small parts that could become detached and create a choking hazard. CAUTION: Danger of explosion if battery is incorrectly replaced. Do not attempt to repair or replace the battery. If the battery is worn out a new headset is required from RDT. Dispose of the headset in accordance with local regulations. Do not dispose as household waste. The user manual for the Sennheiser VMX 200 headset is supplied on the same CD-ROM as this manual. Details from that manual have been reproduced in this section courtesy of Sennheiser®. 10.2.5.3 The Glucometer Batteries The MyGlucoHealth glucometer is powered by user replaceable non-rechargeable batteries. The batteries are conventional types that are available from common retail and industry sources. The glucometer is powered by 2x AAA type batteries. These batteries are rated with a shelf life of 7 years at 20°C. RDT recommends that these are replaced annually when used in a commercial airline application (once a week). Higher levels of usage (e.g. in a training department) may require the batteries to be changed more often. RDT recommends that Varta PowerOne alkaline batteries are used, although many other types are commonly available. Replacement batteries do not need to be sourced from RDT. 10.2.5.3.1 Changing the Glucometer Battery To change the glucometer battery: • First ensure the glucometer is off and then push back the battery cover Removing the MyGlucoHealth Glucometer Battery Cover
Tempus IC User/Operator Manual- USA Page 89 41-1025-03A • Then remove the batteries and dispose of them. • Then replace the batteries with new units of the same type and ratings. Note that the batteries must be inserted in the orientation shown on the inside of the plastic case of the device. CAUTION: After changing the batteries on the MyGlucoHealth glucometer the time must be re-set. See section 8.5.1.1 for details. 10.2.5.4 The Thermometer Battery The thermometer is powered by a user replaceable non-rechargeable battery. The battery is a conventional type that is available from common retail and industry sources. The thermometer is powered by a single lithium CR2 “Photo” type battery. The battery is rated for >90% capacity after 12 months storage at 23°C. RDT recommends that this is replaced annually when used in a commercial airline application (once a week). Higher levels of usage (e.g. in a training department) may require the batteries to be changed more often. RDT recommends that Varta batteries are used, although many other types are commonly available. Replacement batteries do not need to be sourced from RDT. 10.2.5.4.1 Changing the Thermometer Battery To change the thermometer battery: • First push back the battery cover Removing the Thermometer Battery Cover • Then remove the battery and dispose of it. • Then replace the battery with a new unit of the same type and ratings. Note that the battery must be inserted in the orientation shown on the inside of the plastic case of the device. 10.2.6 Disposal of Batteries Dispose of batteries in accordance with the applicable local regulations (these can vary from country to country).2 2 In most countries, the trashing of used batteries is forbidden and the end-users are invited to dispose them properly, eventually through not-for-profit profit organisations, mandated by local governments or organised on a voluntary basis by professionals.
Tempus IC User/Operator Manual- USA Page 90 41-1025-03A 10.3 Troubleshooting Occasionally, problems may occur with the Tempus IC. Operator error, sensor problems or a failure within the Tempus IC could cause these problems. In most instances, the Tempus IC will display an error message on the screen. This section describes the possible error messages and what they mean. All of the error messages take the form of a window which appears in the middle of the screen. The window contains the following text: • a title which identifies the sensor or system which is having trouble • a description of the problem • the effect that the error will have on the performance of the Tempus • which button to press to clear the error message off the screen. CAUTION: In the event that the Tempus IC displays an error that is not described within this manual e.g. Windows applications errors, turn the Tempus IC off and then on again. This should clear the error and allow normal operation to resume. Do not continue to use the device if such an error is displayed. If symptoms persist, please contact RDT 10.3.1 Errors When the device encounters a problem it will display a dialog on the screen. The speaker will announce the message “Attention” followed by the name of the part of the product that the message is concerned with e.g. “Attention – Pulse Oximeter”. The audible alerts are on are played every 5 seconds while an error is being displayed, until the error is cleared. The alert will be played back both through the speaker and the headset. The different error dialogs are shown below. Audio Message Text Message Attention Pulse Oximeter Pulse Oximeter has been disabled. Please restart the Tempus at an appropriate time. If the problem persists contact the manufacturer. Attention Pulse Oximeter The signal from the pulse Oximeter probe is low. Try moving the probe to another finger. Attention Capnometer Capnometer is blocked. Disconnect and reconnect the cannula. Check the cannula for blockages, or kinks. Use the other cannula if the problem persists. Attention Capnometer The capnometer cannula appears not to be plugged into the capnometer. Attention Capnometer Capnometer has been disabled. Please restart the Tempus at an appropriate time. If the problem persists contact the manufacturer. Attention Capnometer Capnometer is not plugged in. Repeat step 2 of the instructions. Attention Capnometer Capnometer sensor error or range error. Unplug the capnometer and follow the instructions. Attention Blood Pressure Blood Pressure has been disabled. Please restart the Tempus at an appropriate time. If the problem persists contact the manufacturer Attention ECG ECG has been disabled. Please restart the Tempus at an appropriate time. If the problem persists contact the manufacturer. Attention ECG Errors in the ECG data were detected during recording; start the recording again.
Tempus IC User/Operator Manual- USA Page 91 41-1025-03A Audio Message Text Message Attention Glucometer The Glucometer is unable to connect at this time. Press the centre button on the glucometer to turn it off and press it again to display the reading in mg/dl. Read it to the Response Centre with the month, day and time. Then get them to read it back to you and CONFIRM it is in mg/dl. Attention Glucometer The Glucometer reading has been received successfully, however the Glucometer clock appears to be incorrect. At a convenient time refer to the User Manual to check the Glucometer clock. Attention Glucometer A valid reading has not been received from the Glucometer. Switch the Glucometer off using the centre button and then retry. Attention Glucometer The Glucometer reading appears to have been taken at a different time. You need to take another reading. Attention Thermometer The thermometer has not linked to the Tempus. Repeat step 5 of the instructions. Attention Battery There is approximately 60 minutes of battery remaining Attention Battery There is less than 30 minutes of battery remaining. Tempus will perform a managed switch-off within 30 minutes. The battery should be changed. Attention Battery The battery requires recharging. Complete ops log or recharge battery. Attention Connection Tempus is already trying to make a connection Attention Connection Tempus is already connected. Attention Connection The Tempus is connected so the mode cannot be changed. Attention Connection You have not completed the data connection process. Are you sure this is what you want to do? Attention Connection Response centre is not responding Attention Headset The headset has not connected to the Tempus. Repeat step 3 of the instructions. Attention Connection You have not completed the data connection process. Are you sure this is what you want to do? Attention Connection You have not completed the voice connection process. Are you sure this is what you want to do? Attention Shutdown A fault has occurred. To clear the problem Tempus will switch off. Please switch back on once the shutdown is complete. If the problem persists please contact your supplier. Attention Shutdown Due to low room temperature Tempus cannot be used and will shutdown. Please allow to warm and restart later. Attention Shutdown Due to high room temperature Tempus cannot be used and will shutdown. Please allow to cool and restart later. Attention Shutdown The battery is empty. Tempus will perform a managed switch-off. The battery should be changed. Attention Headset Please wait, setting up connection to the headset. Attention Headset Headset should be replaced before shutdown Error A fault has occurred To clear the problem Tempus will switch off Please switch back on once the shut-down is complete. If the problem persists please contact your supplier
Tempus IC User/Operator Manual- USA Page 92 41-1025-03A 10.3.2 Thermometer Errors The thermometer display can show a range of error conditions and feedback messages. The thermometer display should be referred to during its use to ensure that this information is seen and responded to. Error Message Problem Solution Device stabilization in process. Repeat the reading (after flashing has stopped) but wait a few seconds after the thermometer has been inserted into the ear before you press the measurement button Battery is low and no more measurements are possible. Replace the battery. Measurement before device stabilization. Repeat the reading (after flashing has stopped) but wait a few seconds after the thermometer has been inserted into the ear before you press the measurement button The device showing a rapid ambient temperature change. Allow the thermometer to rest in a room for at least 30 minutes at room temperature: 10°C and 40°C. The ambient temperature is not within the range between 10°C and 40°C. Allow the thermometer to rest in a room at least 30 minutes at room temperature: 10°C and 40°C Error 5~9, the system is not functioning properly. Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service. Temperature taken is higher than 42.2°C. Check the integrity of the probe cover and take a new temperature measurement. Temperature taken is lower than 34°C. Make sure the probe cover is clean and take a new temperature measurement. Device can not be powered on to the ready stage. Change with a new battery. 10.3.3 Glucometer Errors The glucometer display can show a range of error conditions and feedback messages. The glucometer display should be referred to during its use to ensure that this information is seen and responded to.
Tempus IC User/Operator Manual- USA Page 93 41-1025-03A . 10.3.3.1 Myglucohealth Error Messages Error Message Problem Solution Lo Reading is below 10.8 mg/dl (0.6 mmol/l). Check calibration and retry reading. HI Reading is above 599.4 mg/dl (33.3 mmol/l). Check calibration and retry reading. Lo°C Ambient temperature too low. Allow the meter t o warm up HI°C Ambient temperature too high. Allow meter to cool down Er 1 Problem with the meter Reinstall the battery – if Er 1 persists please email Myglucohealth on support@myglucohealth.com.au Er 2 The test strip is used or polluted Repeat the test with a new test strip Er 3 Problem with the test strip Repeat the test with a new test strip – If Er 3 persists please email Myglucohealth on support@myglucohealth.com.au If display blinks with “sun”, avoid direct sunlight and retest Er 4 Problem with the test strip Repeat the test with a new test strip Er 5 The blood sample was applied before the device was ready Repeat the test and ensure the blood is only applied after the test symbol appears on the glucometer
Tempus IC User/Operator Manual- USA Page 94 41-1025-03A 11 Spares List of the Tempus IC The following user-replaceable accessories and consumables are available from the RDT. 01-1001 Battery Pack 01-1002 Blood Pressure Cuff – Adult 01-1003 Blood Pressure Cuff – Large Adult 01-1004 Blood Pressure Cuff – Child 01-1005 Lo-Flo® Capnometer 01-1006 Blood Pressure Hose 01-1007 Capnometer Cannula - Adult Nasal 01-1008 Pulse Oximeter Sensor 01-1009 Extension Reel 01-1010 12 Lead ECG Harness 01-1011 Bluetooth® Thermometer 01-1012 Battery Charger 01-2015 Bluetooth® Glucometer (MyGlucoHealth™) 01-1014 Dual Modem Cable 01-1015 Mains Cable Pack 01-1016 Bag (empty) 01-1017 Mains Power Supply 01-1018 Bluetrek® Headset 01-2018 Sennheiser VMX 200 Bluetooth® Headset 01-1019 Wired Headset 01-1020 Consumables Replenishment Kit 01-1021 Ethernet Cable 01-1022 USB Serial Cable 01-1023 Ethernet – POTS adaptor 01-2020 Glucometer Replenishment Kit (MyGlucoHealth™) 01-1025 ECG Elastic Wrist Straps (Pair) 01-2043 MyGlucoHealth Control Solution COMBO Pack (Low-Normal-High) 01-1030 RJ-11 Extension Reel (20m) 01-1031 Single Modem Cable 01-1035 Bag Front Pocket Clips 02-1001 Accessory Pouch (note – only supplied to commercial airlines)
Tempus IC User/Operator Manual- USA Page 95 41-1025-03A 12 Configuring the Tempus IC NOTE: The iAssist help processes on your Tempus IC may differ from this example iAssist help process in the following sections. However the process always follows the same key elements. NOTE: Always ensure that you read the complete iAssist help process in order and do exactly what it requires. A number of the parameters used by Tempus IC are configurable to suit certain requirements. To configure the device, press the button to bring up the Help Menu. Then to access the Settings menu press Cleaning and Repacking touchscreen button followed by pressing the Settings touchscreen button. The Help Menu The Cleaning and Repacking Menu Press the Settings button in the Cleaning & Repacking Menu on the touchscreen to bring up the Settings Menu. Press the touchscreen here Press the touchscreen here
Tempus IC User/Operator Manual- USA Page 96 41-1025-03A Settings Menu Press the Settings button in the Settings Menu on the touchscreen to bring up the configurable options. System Settings Press the touchscreen to select the configurable parameters and press OK touchscreen button to confirm the changes you have made. Press the touchscreen here to configure the device Press the touchscreen here Press the touchscreen here for the main device settings
Tempus IC User/Operator Manual- USA Page 97 41-1025-03A Configuration Information The configuration of the device can be seen in the configuration screen. .
Tempus IC User/Operator Manual- USA Page 98 41-1025-03A 13 Specifications and Standards 13.1 Specifications Note that all figures quoted are based on room temperature, pressure and humidity unless otherwise stated. 13.1.1 Non-invasive Blood Pressure 13.1.1.1 Adult cuff and Large Adult cuff ratings Systolic: 60 - 250 mmHg Diastolic: 40 - 220 mmHg Range: 0 - 330 mmHg Accuracy: ± 3mmHg or ± 2% (whichever is greater) Resolution: 1 mmHg Maximum inflation: 330mmHg 13.1.1.2 Child cuff ratings Systolic: 60 - 250 mmHg Diastolic: 40 - 220 mmHg Range: 0 - 330 mmHg Accuracy: ± 3mmHg or ± 2% (whichever is greater) Resolution: 1 mmHg Maximum inflation: 330mmHg 13.1.2 ECG Recorder Gain/Sensitivity 5, 10, 20 mm/mV Input Range ±6mV Acquisition sample rate 1000 samples per second (compressed to 500Hz with peak picking and averaging algorithm) Frequency response 0.05 to 175Hz ±3dB Defibrillator protection Patient leads are isolated from system and operator, with 4kV protection Common Mode Rejection -60dB (minimum) Leads Off Indicators Connection status for each lead is shown on Acquisition screen Permanent Filters High Pass: 0.05Hz 1st order Low Pass: 170Hz 1st order Baseline Wander: Baseline reset by adaptive zeroing algorithm Notch filter (Mains Noise Rejection) 50Hz 4th order Butterworth, 49.1Hz - 50.9Hz, 60Hz 4th order Butterworth, 59.1Hz - 60.9Hz Low pass (Muscle Artifact Filter) 35Hz 4th order
Tempus IC User/Operator Manual- USA Page 99 41-1025-03A 13.1.3 ETC02 Sensor Unless otherwise stated, all CO2 measurements are made following an airway adapter zero, with 5% CO2 gas, balance N2 at 25 degrees C, and Pb = 760 mmHg with 2 litres per minute flow. The stabilization time for full specification testing of the LoFlo Module over the entire temperature range is 20 minutes. Range: 0-100 BPM Accuracy: ± 2 BPM Range: 0-10% CO2 displayed value Accuracy: ± 4% Rise time: <2 seconds Delay time: 5 seconds Operating altitude range: 0-15000 feet The capnometer is automatically compensated for local atmospheric pressure. Physical characteristics: Module weight is less than 9.6 oz (272.16 g) Module Size: < 2.6" wide x 1.5" high x 3.5" deep [< 66.0 x 38.1 x 88.9 mm] Cable length – 19 inches (46 cm) Carbon Dioxide Monitoring Mode of Sampling Sidestream Principle of Operation Non-dispersive infrared (NDIR) single beam optics, dual wavelength, no moving parts. Initialization Time Measurement displayed in less than 20 seconds, At an ambient temperature of 25° C, full specifications w ithin 2 minutes. CO2 Measurement Range 0 to 150 mmHg 0 to 19.7% 0 to 20 kPa (Barometric Pressure supplied by RDT) CO2 Calculation Method BTPS (Body Temperature Pressure Saturated) CO2 Response Time <3 seconds - includes transport time and rise time CO2 Resolution 0.1 mmHg 0 to 69 mmHg 0.25 mmHg 70 to 150 mmHg CO2 Accuracy * 0 - 40 mmHg ± 2 mmHg 41 - 70 mmHg ± 5% of reading 71 - 100 mmHg ± 8% of reading 101 - 150 mmHg ± 10% of reading Above 80 breath per minute ± 12% of reading * NOTE: Gas temperature at 25° C. CO2 Stability Short Term Drift: Drift over four hours shall not exceed 0.8 mmHg maximum. Long Term Drift: Accuracy specification will be maintained over a 120 hour period. CO2 Noise RMS noise of the sensor shall be less than or equal to 0.25 mmHg at 5% CO2 Sampling Rate 100 Hz Respiration Rate Range 2 to 150 breaths per minute (BPM) Respiration Rate Accuracy ± 1 breath Calibration No routine user calibration required.
Tempus IC User/Operator Manual- USA Page 100 41-1025-03A Carbon Dioxide Monitoring ETCO2 Calculation Method: Peak of the expired CO2 waveform Selections: 1 breath, 10 second, 20 second Inspired CO2 Measurement Range: 3 to 50 mmHg Method: lowest reading of the CO2 waveform in the previous 20 seconds Selection: 20 seconds (not user-selectable) Compensations (RDT Controlled) Compensations for: Expired O2, Balance gas (N2, N2O, He) and Anaesthetic AgentsB Uses gas compensation information and barometric pressure to correct the raw carbon dioxide value O2 Compensation Range: 0 to 100% Resolution: 1% Default: 16% Airway Pressure Range: + 120 cmH2O (88.27 mmhg) - 45 cmH2O (33.1 mmHg). Anaesthetic Agent Effects (MAC levels) Anaesthetic Agent SensitivityA (uncompensated) Accuracy specification will be maintained for halogenated anaesthetic agents present at accepted MAC (Minimum Alveolar Concentration) clinical levels. Anaesthetic Agent Sensitivity (compensated) Testing at Agent levels defined by accepted regulatory standards (i.e. ISO 21647, ASTM F1456, IEC/CDV 60601-2-55) currently in process. Cross-sensitivity Compensation Error* 0-40 mmHg: ± 1 mmHg additional error 41-70 mmHg: ± 2.5% additional error 71-100 mmHg: ± 4% additional error 101-150 mmHg: ± 5% additional error * Additional worst case error when compensation for Pb, O2, N2O, anaesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. Gas or Vapour Halothane Enflurane Isoflurane Desflurane MAC Level % (v/v) 0.74 1.68 2.00 6.30 (From Olivier C. Wenker: Review of Currently Used Inhalation Anesthetics: Part I. The Internet Journal of Anesthesiology, 1999, Volume 3 Number.) Gas or Vapour Gas Level Quantitative Effects Nitrous oxide 60% No Additional Effect
Tempus IC User/Operator Manual- USA Page 101 41-1025-03A Gas or Vapour Gas Level Quantitative Effects Halothane 4% No Additional Effect Enflurane 5% No Additional Effect Isoflurane 5% No Additional Effect Sevoflurane 5% No Additional Effect Xenon 80% Negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38 mmHg Helium 50% No Additional Effect Metered dose inhaler propellants Unspecified Unspecified Desflurane 15% Concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38 mmHg. Ethanol 0. 1% No Additional Effect Isopropanol 0.1% No Additional Effect Acetone 0.1% No Additional Effect Methane 1% No Additional Effect Environmental: Temperature and Humidity Operating 0 to 40°C, 10 to 90% RH, non-condensing Storage -40 to 70°C, 10 to 90% RH, non-condensing Water Resistance IPX4 - Splash-proof - Module only (When Sample Cell is inserted into Sample Cell Receptacle) Shock Impact IEC TR 60721-4-7 Class 7M3 (designed to withstand environments subject to significant vibrations or high shock levels) EN60068-2-27 Shock EN60068-2-64 Random Vibration 13.1.4 SpO2 Sensor Pulse Range: 25-300 bpm Graphic display range: 25-175 bpm Accuracy: ± 2bpm or ±2% whichever is greater Resolution: 1bpm Averaging: 8 seconds
Tempus IC User/Operator Manual- USA Page 102 41-1025-03A SpO2 Range: 0-100% Graphic display range: 50-100% Accuracy: ±2% at 70%-100% Resolution: 1% Type: Functional saturation (test methods available upon request) Wavelength range: Red 660nm, infra-red 905nm Perfusion Index range: 1-20% Signal strength range: 1-7 bars 13.1.5 Thermometer Temperature measurement range: 34-42.2°C (93.2-108 °F) Operating temperature range: 10-40°C (50-104°F) Storage temperature Range: -20-50°C (-4-122°F), RH 85% (non-condensing) Transportation temperature: <70°C, RH95% (non-cond ensing) Compliance with: ASTM E1965-98, EN12470-5:2003 Clinical thermometers-Part 5:Performance of infra-red ear thermometers(with maximum device),IEC/EN60601-1-2(EMC),IEC/EN60601-1(Safety) standards. Accuracy: +/-0.2 °C (0.4 °F) between 35.5~42°C (95.9~107.6°F) and +/-0.3 °C (0.5 °F) outside this range. Display type: oral equivalent Range: 10m (free field) Weight: 100g (including battery) Battery: 3V CR2 Size: 167mm x 39mm x 45mm (max). Environmental range: The thermometer has the same environmental range as the Tempus IC, see section 13.1.7 Drop/Shock: The thermometer has been tested to the same range of environmental standards as the Tempus IC (see section 13.1.7.1 RDT recommends that the batteries are replaced annually when used in a commercial airline application (once a week). Higher levels of usage (e.g. in a training department) may require the batteries to be changed more often. The Thermometer uses the Bluegiga WT12A Bluetooth® module. This is unmodified by RDT and is provided under FCC ID QOQWT12 under FCC part 15C and Industry Canada REL: 5123A-BGTWT12A under RSS210. It operates in the frequency bands 2402MHz – 2480MHz and has a maximum power of 0.00222W. Bluetooth® Specification Description Specification Note Operating frequency range (2400 ... 2483,5) MHz ISM Band
Tempus IC User/Operator Manual- USA Page 103 41-1025-03A Bluetooth® Specification Description Specification Note Range Class 2, range up to 10 meters in an open field Lower guard band 2 MHz Upper guard band 3,5 MHz Carrier frequency 2402 MHz ... 2480 MHz f = 2402 + k, k = 0...78 Modulation method GFSK (1 Mbps) P/4 DQPSK (2Mbps) Hopping 1600 hops/s, 1 MHz channel space Maximum data rate GFSK: Asynchronous, 723.2 kbps / 57.6 kbps Synchronous: 433.9 kbps / 433.9 kbps P/4 DQPSK: Asynchronous, 1448.5 kbps / 115.2 kbps Synchronous: 869.7 kbps / 869.7 kbps 8DQPSK: Asynchronous, 2178.1 kbps / 177.2 kbps Synchronous: 1306.9 kbps / 1306.9 kbps Receiving signal range -82 to -20 dBm Typical condition Receiver IF frequency 1.5 MHz Center frequency Transmission power Min -11 ... -9 dBm Max +14 ... +18 dBm RSS210 22mW emission designation 1M21G2D Compliance Bluetooth® specification, version 2.0 + EDR Certification/ Compliance FCC: Part 15, FCC ID QOQWT12 Industry Canada license 5123A-BGTWT12E 13.1.6 Glucometer 13.1.6.1 MyGlucoHealth Sample Type Capillary Whole Blood Sample Volume 0.3 µL Test Range 10-600 mg/dL (0.6-33.3 mmol/L) Reading Time 3 seconds Calibration Auto Coding, Plasma Calibrated Altitude Sea Level up to 10,000 ft. (3048 m) Operating Temp. 50°- 104°F (10 - 40°C )
Tempus IC User/Operator Manual- USA Page 104 41-1025-03A Operating Humidity 10 - 90% Strip Storage Temp. 36°- 86°F (2°- 30°C) Display Type LCD Dimensions 2.1 X 3.9 X 0.9 (in) (52.2 X 98.5 X 23.4 mm) Weight 2.6 oz. (74.5g) (including batteries) Power Source 3 V (Alkaline Battery, 1.5V AAA Size X 2) Battery Life 2,000 Tests The Glucometer uses the Movon MD-4DR Bluetooth® module. This is unmodified by RDT and is provided under FCC ID VUG-EHS-MGEU00001 under FCC part 15C. It operates in the frequency bands 2402MHz – 2480MHz and has a maximum power of 0.00256W. Bluetooth® Specification Description Specification Note Operating frequency range (2402 ... 2480) MHz ISM Band Range Class 2, range up to 3 meters in an open field Output power 2-4dBm Power Density 20dBm 20dB bandwidth 850-1000KHz Modulation characteristics F1avg 140-175KHz F2 max 115KHz Carrier frequency drift ±25KHz one slot packet, ±40KHz 3-5 slot packets Receiver sensitivity -80dBm single slot packets -70dBm multi slot packets Maximum input level -5dBm Compliance Bluetooth® specification, version 2.0 + EDR
Tempus IC User/Operator Manual- USA Page 105 41-1025-03A 13.1.7 Environmental Specifications Altitude: 0-4500m (0-15000ft) (can be used at higher physical altitudes provided the local atmosphere is no higher than 4500m, e.g. in a pressurised aircraft cabin) Relative humidity: 15%-95% (non-condensing) Operating temperature range: 0ºC to 40ºC Storage temperature range: -20ºC to +60ºC NOTE: Note that the IP sealing has a warranty of 1 year. NOTE: IPX6 and MIL810F tests are lab tests and not normal condition. The unit remains intact and functional after tests but rough handling may degrade performance specification i.e. if you hit it with steel ball then IP sealing around the case may degrade, if you drop it from 1.2m then IP sealing may degrade and a drop tests may damage peripherals. Drop test performance specifications relate to a standalone device with no cables connected. 13.1.7.1 Environmental Performance and Certification Temperature & Altitude: Category: A1 Test Standard, Temperature, RTCA/DO-160E Section 4, Para 4.5.1, 4.5.2 and 4.5.3 Test Standard, Altitude, RTCA/DO-160E Section 4, Para 4.6.1 and 4.6.2 Temperature: Operating: 0°C to +40°C Storage: -20°C to +60°C Short Term High: +40°C Altitude: Operating: Sea Level to 15,000 ft Storage: Sea Level to 15,000 ft Rapid Decompression: 10,000 ft to 55,000 ft in 10 seconds Temperature Variation: Test Standard: RTCA/DO160E Section 5 Cat C Rate of Variation: 2°C per minute. Humidity: Test Standard: RTCA/DO-160E Section 6 Cat A Storage: 15 to 95% RH Non-condensing (tested for 48 hours at 38-50°C) Operating: 15 to 95% RH Non-condensing (tested at the end of the storage cycle) Operational Shocks & Crash Safety: Test Standard: RTCA/DO-160E Section 7 Cat B Operational Shock: Para 7.2 (6g for 11ms saw-tooth wave, repeated 3 times in all axis). Crash Safety: 20g in all directions (sustained and impulse). Vibration: Test Standard: RTCA/DO-160E Section 8 Para 8.5.2 Jet aircraft test Procedure: Curve B3, 3hrs per axis (repeated for all axis) – 10 Hz to 31 Hz at 0.02 g2/Hz Falling to 0.002 g2/Hz at 100 Hz 100 Hz to 500 Hz at 0.002 g2/Hz Falling to 0.00013 g2/Hz at 2000 Hz
Tempus IC User/Operator Manual- USA Page 106 41-1025-03A Helicopter test Procedure: Curve F, 0.5hrs per axis (repeated for all axis) – 5 Hz to 40 Hz at a ramp rate of +3 dB/Oct to a level of 0.05 g2/Hz at 40 Hz 40 Hz to 200 Hz at 0.05 g2/Hz Ramping from 200 Hz to 300 Hz at a ramp rate of -12 dB/Oct Procedure: Curve F1, 3.5hrs per axis (repeated for all axis) – 5 Hz to 40 Hz at a ramp rate of +3 dB/Oct to a level of 0.10 g2/Hz at 40 Hz 40 Hz to 200 Hz at 0.10 g2/Hz Ramping from 200 Hz to 300 Hz at a ramp rate of -12 dB/Oct Explosion Proofness: Not tested. Not to be used in the presence or explosive gasses or vapours. Water Proofness: Not tested to RTCA/DO160E Section 10. Commercial qualification: IPX6 (high pressure hose) – whole device IPX4 (hoop) – capnometer IPXX (no classification) – glucometer, thermometer, power supply, battery charger, headset Fluids Susceptibility: Not applicable. The product is for use in the cabin only. Sand & Dust: Not applicable. The product is for use in the cabin only. Fungus Resistance: Not applicable. The product is for use in the cabin only. Salt Spray: Not applicable. The product is for use in the cabin only. Magnetic Effect: Not applicable. The product is for use in the cabin only. Power Input: Not tested to RTCA/DO160E Section 16. Commercial qualification: EN61000-3-2:2006 Mains harmonics EN61000-3-3:1995 inc A1:2001 & A2:2005 Mains flicker EN61000-4-11:2004 voltage dips and interruptions Voltage Spike: Not tested to RTCA/DO160E Section 17. Commercial qualification: EN61000-4-4:2004 Fast transient bursts
Tempus IC User/Operator Manual- USA Page 107 41-1025-03A Audio Frequency Conducted Susceptibility – Power inputs: Not tested to RTCA/DO160E Section 18. Commercial qualification: EN61000-4-5:2006 Surges Induced Signal Susceptibility: Not tested to RTCA/DO160E Section 19. Commercial qualification: EN61000-4-6:1996 inc A1:2001 Conducted RF field Radio Frequency Susceptibility (Radiated & Conducted): Not tested to RTCA/DO160E Section 20. Commercial qualification: EN61000-4-3:2002 Radiated RF Interference Emission of Radio Frequency Energy: Test Standard: RTCA/DO160E Section 21 Cat M. Lightning Induced Transient Susceptibility: Not applicable. The product is for use in the cabin only. Lightning Direct Effects: Not applicable. The product is for use in the cabin only. Icing: Not applicable. The product is for use in the cabin only. ESD: Not tested to RTCA/DO160E Section 25. Commercial qualification: EN61000-4-2:1995 inc A1:1999 & A2:2001 ESD Fire and Smoke Hazards: Main case material: Glass reinforced nylon PA66+35%GF. Flame: UL94V-0 Overmould material: TPE. Flame: N/A
Tempus IC User/Operator Manual- USA Page 108 41-1025-03A 13.1.8 Miscellaneous Features and Specifications Tempus IC dimensions 289mm wide x 203mm high x 101mm deep. 13.1.8.1 Rechargeable battery Battery life At least 7 hours running in normal use. Nominal voltage 7.4V Charging voltage 8.4V ±1% Nominal capacity 8.7Ah Weight 0.42kg nominal Shelf life Approximately 80% remaining after 1 year (before the charge indicator light turns to Amber) Battery shelf life and run times are based on a new, fully charged battery stored in normal room ambient conditions. Run time is based on RDT’s model of typical device usage in an incident. 13.1.8.2 Battery Charger Mains input voltage 100-240V Frequency 50-60Hz Input current 0.9A max (at 100V approx.) Output voltage 8.4V dc Output current <2.73A Charge time (from empty) 6 hours NOTE: Only the RDT Battery Charger pn 01-1012 can be used with the Tempus IC. 13.1.8.3 Mains Power Supply Mains input voltage 100 - 240V Frequency 50-60Hz Input current 1.5A - 0.55A Output voltage 12V dc Output current 5A NOTE: Only the Cincon Electronics TR60M12 as supplied by RDT can be used with the Tempus IC. 13.1.8.4 GPS Antenna Integral Channels 20 satellites simultaneously Sensitivity Up to -159dBm Accuracy ±30m (±2.5km with <6 satellites – labelled as “Approximate Fix” 13.1.9 Communications FCC & Industry Canada Notes on Wireless Communications CAUTION: Do not disassemble the device. There are no user-serviceable parts inside. Refer servicing to the manufacturer. Changes or modifications not expressly approved by RDT could void the user’s authority to operate the equipment.
Tempus IC User/Operator Manual- USA Page 109 41-1025-03A This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules and Industry Canada Radio Standard RSS 210. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Operation is subject to the following two conditions: • This device may not cause interference and • This device must accept any interference, including interference that may cause undesired operation of the device. This equipment is also ETS 300 328, ETS 300 826, ETS 300 328-2, ETS EN301 489-1 and ETS EN301 489-17 compliant. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. The user may find the following booklet helpful: How to Identify and Resolve Radio-TV Interference Problems. This booklet is available from U.S. Government Printing Office, Washington, D.C. 20402. Radio Frequency Interference Requirements – Canada This Class B digital apparatus meets the requirements of the Canadian Interference-Causing Equipment Regulations. 13.1.9.1 Transmission rates ECG data and digital pictures take an appreciable amount of time to send to the Response Centre, approximate times are as follows: • 12 lead ECG – 2-3 minutes • Digital photographs – 2-3 minutes. These times are for guidance only and are based on the worst case communications system (off-aircraft satellite link running at 2.4Kbaud V22BIS) and may vary depending on the quality of the connection. 13.1.9.2 Bluetooth® Specification (FCC ID: ROSTEMPUSIC-BT or ROSTEMPUSIC-1) Bluetooth® Specification Description Specification Note
Tempus IC User/Operator Manual- USA Page 110 41-1025-03A Bluetooth® Specification Description Specification Note Operating frequency range (2400 ... 2483,5) MHz ISM Band Range Class 1, range up to 100 meters in an open field Lower guard band 2 MHz Upper guard band 3,5 MHz Carrier frequency 2402 MHz ... 2480 MHz f = 2402 + k, k = 0...78 Modulation method GFSK (1 Mbps) P/4 DQPSK (2Mbps) Hopping 1600 hops/s, 1 MHz channel space Maximum data rate GFSK: Asynchronous, 723.2 kbps / 57.6 kbps Synchronous: 433.9 kbps / 433.9 kbps P/4 DQPSK: Asynchronous, 1448.5 kbps / 115.2 kbps Synchronous: 869.7 kbps / 869.7 kbps 8DQPSK: Asynchronous, 2178.1 kbps / 177.2 kbps Synchronous: 1306.9 kbps / 1306.9 kbps Receiving signal range -82 to -20 dBm Typical condition Receiver IF frequency 1.5 MHz Center frequency Transmission power Min -11 ... -9 dBm Max +14 ... +18 dBm RSS210 22mW emission designation 1M21G2D RF input impedance 50Ω Compliance Bluetooth® specification, version 2.0 + EDR 13.1.9.3 Bluetooth® Bluetrek Headset Specification The Tempus IC uses the Bluetrek® G3 wireless headset. This is unmodified by RDT and is provided under FCC ID QITBTG3 under FCC part 15C and under AusCom approval N1342 It operates in the frequency bands 2402MHz – 2480MHz and has a maximum power of 0.00297W.
Tempus IC User/Operator Manual- USA Page 111 41-1025-03A Wireless Performance Specifications Description Transmitter Receiver Operating frequency range 2402 - 2480 MHz 2402 - 2480 MHz Type of modulation FHSS modulation FHSS modulation Number of channels 79 79 Channel separation 1MHz 1MHz Type of antenna Ceramic type Antenna gain (dBi) 0 Power level Fixed Description General Specifications Bluetooth® type V1.2 class 2 Range 10m max in an open field Weight 12g Size 67.5mm x 19.5mm Talk time Up to 13 hours* *Based on the manufacturer’s specification – can be 12.5 hours in HV3, 10 hours in HV2 and 5.3 hours in HV1 modes (HV level set by host device). Battery shelf life and run times are based on a new, fully charged battery. 13.1.9.4 Bluetooth® Sennheiser Headset Specification The Tempus IC uses the Sennheiser® VMX 200 wireless headset. The Tempus Pro uses the Sennheiser® VMX 200 wireless headset. This is unmodified by RDT and is provided under the USA FCC ID: DMOCBMSAD under FCC part 15C and an Industry Canada License IC: 2099D-VMX 200 and an Auscom number N340. It operates in the frequency bands 2402MHz – 2480MHz. Users are reminded to refer to the Sennheiser user guide (attached to the CD-ROM provided with the Tempus IC) that provides instructions for use of the headset. These include environmental performance specifications which may differ from those of the Tempus IC. Description General Specifications Bluetooth® type Version 3.0, class 2 Range 10m max in an open field Transmission frequency 2402 MHz to 2480 MHz Bluetooth® Profiles HSP, HFP Weight 10g Size 55 x 26 x 58 mm (WxHxD) Talk time Greater than 4 hours* Operating temperature range +10°C (+50°F) to +40°C (+104°F) Operating humidity range 20 to 85%, non-condensing Storage temperature range -20°C (-4°F) to +60°C (140°F)
Tempus IC User/Operator Manual- USA Page 112 41-1025-03A Description General Specifications Storage humidity range 10 to 95%, non-condensing *Battery shelf life and run times are based on a new, fully charged battery. 13.1.9.5 WiFi Specification: 13.1.9.5.1 FCC ID: ROSTEMPUSIC-1 The WiFi technology used by the Tempus operates using IEEE 802.11b and 802.11g standard. It operates in the Industrial, Scientific and Medical (ISM) band between 2.412GHz and 2.484Hz. The WiFi technology has the following features: WiFi Specification The WiFi module has the following specifications: SKU # North America WL6231-1123 International WL6233-1125 Transmit Power CCK: 12 dBm typical OFDM: 9 dBm typical 63mW emission designation 11M5F9W to spec RSS210 Indoor Range ~ 300 feet (typical office environment) Data Rate: 802.11a 54 Mbps OFDM: 9 dBm +1/-1.5 dBm 802.11g 54 Mbps OFDM: 11 dBm +1/-1.5 dBm 802.11b 11 Mbps CCK: 15 dBm +1/-1.5 dBm Frequency Range: North America: 2.412-2.462 GHz, channels 1-11 Europe ETSI: 2.412-2.472 GHz, channels 1-13 Japan: 2.412-2.484 GHz, channels 1-14 Security Encryption/Authentication Hardware Support: WEP 64/128, WPA (TKIP/AES), WPA2 (TKIP/AES) 13.1.9.5.2 FCC ID: P5T-WL54SDIO The WiFi technology used by the Tempus operates using IEEE 802.11b and 802.11g standard. It operates in the Industrial, Scientific and Medical (ISM) band between 2.412GHz and 2.484Hz. The WiFi technology has the following features: WiFi Specification The WiFi module has the following specifications: SKU # WL54-SDIO Transmit Power CCK: 14 dBm typical (25.119 mW) OFDM:11 dBm typical (12.589 mW) Indoor Range ~ 300 feet (typical office environment)
Tempus IC User/Operator Manual- USA Page 113 41-1025-03A WiFi Specification Data Rate: 802.11g 54 Mbps OFDM: 11 dBm +1/-1.5 dBm 802.11b 11 Mbps CCK: 14 dBm +1/-1.5 dBm Frequency Range: North America: 2.412-2.462 GHz, channels 1-11 Europe ETSI: 2.412-2.472 GHz, channels 1-13 Japan: 2.412-2.484 GHz, channels 1-14 Security Encryption/Authentication Hardware Support: WEP 64/128, WPA (TKIP/AES), WPA2 (TKIP/AES) 13.1.9.6 GSM & GPRS Specification (FCC ID: ROSTEMPUSIC-2 or ROSTEMPUSIC-1) The Cell Phone (GSM) technology used by the Tempus has the following specifications: GSM/GPRS Specification Operating frequency range Parameter Min Max Unit Frequency Range Uplink (MS → BTS) GSM 850 824 849 MHz E-GSM 900 880 915 MHz GSM 1800 1710 1785 MHz GSM 1900 1850 1910 MHz Frequency Range Downlink (BTS → MS) GSM 850 869 894 MHz E-GSM 900 925 960 MHz GSM 1800 1805 1880 MHz GSM 1900 193 1990 MHz RF power Parameter Min Max Unit RF power @ARP with 50Ω Load GSM 850 31 35 dBm E-GSM 900 31 35 dBm GSM 1800 28 32 dBm GSM 1900 28 32 dBm Number of carriers Band Channels GSM 850 124 E-GSM 900 174 GSM 1800 374 GSM 1900 299 Duplex Spacing Band Typical GSM 850 45 MHz E-GSM 900 45 MHz GSM 1800 95 MHz GSM 1900 80 MHz Carrier Spacing 200 KHz Multiplex, Duplex TDMA / FDMA, FDD Time Slots Per TDMA 8
Tempus IC User/Operator Manual- USA Page 114 41-1025-03A Fame Frame duration 4.615mS Time Slot duration 577ųS Modulation GMSK Receiver input sensitivity @ ARP BER Class II < 2.4% (static input level) Parameter Min Typ Unit GSM 850 -1023 -1074 dBm E-GSM 900 -1023 -1074 dBm GSM 1800 -1023 -1074 dBm GSM 1900 -1023 -1074 dBm Note: This device contains GSM 900 MHz and GSM 1800MHz functions that are not operational in U.S. Territories. 13.1.9.7 Ethernet Specification The Ethernet connection has the following specifications: • IEEE 802.3 compliant • RJ-45 connection • DHCP or fixed IP, Mask, Gateway and DNS • Optional Type of Service setting • Protocol: TCP Port 2167 • Network diameter: at least 100m 13.1.9.8 Modem Specification The Tempus IC contains two modems which can be connected to a telephone network via the RJ-45 connector. The modems are used either: • together over 2k4baud channels (typically Inmarsat classic satcoms for aero or maritime applications where one modem is used to transmit data and the other voice); • or in landline applications where the a single modem is used to transmit voice and data simultaneously. The modems support the following data protocols: V.92; V.90, V.34, V.32bis, V.32, V.22bis, V.22, V.23, V.21, Bell 212A & Bell 103. Error correction uses V.42 (LAP-M or MNP 2–4). 13.1.9.9 USB-Serial Adaptor Specification The Tempus IC’s USB connector may be used with the USB-Serial Adaptor cable (pn 01-1022) in order to provide data or voice and data communications over serial (RS-232) channels such as Iridium (data only) or Sat B (voice and data). Data speeds of from 9600baud. 13.1.10 Tempus IC Device Classification The system is classified according to the requirements of EN60601-1:1990 inc. A13:1996, the standard for Medical Electrical Equipment, Part 1, General Requirements for Safety, Clause 5 as: 5.1 The Tempus IC is Internally (battery) powered – when powered by an external power supply it is class II as defined by the classification labelled on the power supply specified and supplied by RDT. The thermometer is internally (battery) powered. 5.2 Applied parts type CF defibrillator proof, thermometer classified as BF, glucometer is not classified as it is an IVD rather than a medical device.
Tempus IC User/Operator Manual- USA Page 115 41-1025-03A 5.3 The Tempus IC is rated IPX6, protected against rainfall according to IEC529. The capnometer is rated IPX4. All other parts are rated IPXX. 5.4 No parts supplied sterile or suitable for/requiring sterilising 5.5 Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide 5.6 Suitable for continuous use Note that the classification of the thermometer is different to those of the Tempus IC. The thermometer is: • rated type BF, • not protected against the effects of a cardiac defibrillator discharge, • internally powered only (no means of connecting external power), • not supplied sterile or has any parts which are required to be sterilised, • not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide, • is intended for intermittent use (it measures discrete readings rather than being used continuously) – the product will automatically power off after a minute if it is not used. Similarly it should be noted that the glucometer is not classified under IEC60601-1. This is because the glucometer is classified as an IVD (invitro-diagnostic device) rather than a patient applied medical device. 13.1.11 Standards Compliance The Tempus IC complies with the applicable parts of the following standards: Standard Title IEC 60601-1 2nd edition: 1988 Amendment A1:1993, A11:1993, A12:1993, A1:1995, A13:1996 Medical electrical equipment: General requirements for safety (as amended) IEC 60601-1-1:2000 – reference standard only Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:2005 Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-4:1996 Amendment A1:1999 Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (as amended) IEC 60601-1-6:2004 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Usability IEC 60601-2-25:1993 Amendment A1:1999 Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-30:1999 Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
Tempus IC User/Operator Manual- USA Page 116 41-1025-03A Standard Title IEC 60601-2-49:2006 Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment ISO 21647:2004 ISO 21647:2004/AC:2006 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (as amended) ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use ISO 14971:2007 Medical devices - Application of risk management to medical devices EN 60529:1992 Specification for degrees of protection provided by enclosures (IP code) EN 980:2008 Graphical symbols for use in the labelling of medical devices EN 1041:1998 Information supplied by the manufacturer of medical devices ISO 10993-1: 2003 Biological evaluation of medical devices - Part 1: Evaluation and testing RTCA/DO160E Environmental conditions and test procedures for airborne equipment UL 1642 Issue 4 Standard for lithium batteries 13.1.11.1 EMC Information The following tables provide information required to be provided under IEC60601-1-2. Cable Length of the Sensors and the Accessories RDT Part Number Cable Length (typ.) Tested Length Ethernet cable 01-1021 2.1m 2.1m SpO2 sensor 01-1008 1.5m 1.5m ECG harness 01-1010 1.5m 1.5m Capnometer 01-1005 0.5m 0.5m Wired headset 01-1019 1.2m 1.2m Mains Power supply 01-1017 0.45m 0.45m Mains lead 01-1015 2m 2m WARNING: The use of longer cable lengths may cause an increased emission or a reduced interference resistance. The use of other sensors or cables except the ones mentioned above is not allowed. Manufacturer's Declaration - Electromagnetic Emissions (Tab. 201 according to DIN EN 60601-1-2) The Tempus IC is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment.
Tempus IC User/Operator Manual- USA Page 117 41-1025-03A Emission Measurements Compliance Electromagnetic Environment HF emissions acc. to CISPR11 Group 2 The Tempus IC must emit RF energy in order to perform its function. Nearby electronic devices may be affected. Note that the Tempus IC can be configured for not to emit RF energy in which case it will be group 1 and will not be likely to cause any interference in nearby electronic equipment. HF emissions acc. to CISPR11 Class B The Tempus IC is intended for use in all facilities including living quarters and such ones which are connected directly to a public power supply that supplies also buildings used for living purposes. Emission of overtones acc. to IEC61000-3-2 Class A Emission of voltage fluctuation/flicker acc. to IEC61000-3-3 Complies Manufacturer's Declaration - Electromagnetic Emissions (Tab. 202 according to DIN EN 60601-1-2) The Tempus IC is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment. Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines Electrostatic discharge (ESD) acc. to IEC 61000-4-2 ± 6 kV contact discharge ± 8 kV air discharge ± 6 kV contact discharge ± 8 kV air discharge Floors should be of wood, concrete or ceramic tiles. If the floor is tiled with synthetic material the relative air humidity must have 30 % at least. Fast transient electric disturbances / bursts acc. to IEC 61000-4-4 ± 2 kV for power lines ± 1 kV for input and output lines ± 1 kV for input and output lines Signal distortion on the ECG waveform and heart rate fluctuations may be observed while disturbance occurs. The quality of the supply voltage should conform to a typical business or clinic environment. Surge voltage acc. to IEC 6100-4-5 ± 1 kV normal mode voltage ± 2 kV common mode voltage ± 1 kV normal mode voltage ± 2 kV common mode voltage Mains power should be that of a typical hospital or commercial environment. Voltage drops, short interruptions and variations in supply voltage acc. to IEC 61000-4-11 < 5 % UT (>95 % break of UT for 0,5 period 40 % UT (60% break of UT) for 5 periods 70 % UT (30% break of UT) for 25 periods < 5 % UT (>95 % < 5 % UT (>95 % break of UT for 0,5 period 40 % UT (60% break of UT) for 5 periods 70 % UT (30% break of UT) for 25 periods < 5 % UT (>95 % Mains power should be that of a typical hospital or commercial environment. If the user of the Tempus IC requires continued operation during power interruptions then the
Tempus IC User/Operator Manual- USA Page 118 41-1025-03A Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines break of UT for 5 seconds break of UT for 5 seconds battery may be used for periods up to 6 hours or a UPS may be used. Magnetic field at the supply frequency (50/60 Hz) acc. to IEC 61000-4-8 3 A/m 3 A/m Magnetic fields at the supply frequency should conform to the typical values as they occur in the business or clinic environment. NOTE UT is the AC mains voltage before the use of testing levels Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines Electrostatic discharge (ESD) acc. to IEC 61000-4-2 ± 6 kV contact discharge ± 8 kV air discharge ± 6 kV contact discharge ± 8 kV air discharge Floors should be of wood, concrete or ceramic tiles. If the floor is tiled with synthetic material the relative air humidity must have 30 % at least. Fast transient electric disturbances / bursts acc. to IEC 61000-4-4 ± 2 kV for power lines ± 1 kV for input and output lines ± 1 kV for input and output lines Signal distortion and heart rate fluctuations may be observed while disturbance occurs. The quality of the supply voltage should conform to a typical business or clinic environment. Surge voltage acc. to IEC 6100-4-5 ± 1 kV normal mode voltage ± 2 kV common mode voltage ± 1 kV normal mode voltage ± 2 kV common mode voltage Mains power should be that of a typical hospital or commercial environment. Voltage drops, short interruptions and variations in supply voltage acc. to IEC 61000-4-11 < 5 % UT (>95 % break of UT for 0,5 period 40 % UT (60% break of UT) for 5 periods 70 % UT (30% break of UT) for 25 periods < 5 % UT (>95 % break of UT for 5 seconds < 5 % UT (>95 % break of UT for 0,5 period 40 % UT (60% break of UT) for 5 periods 70 % UT (30% break of UT) for 25 periods < 5 % UT (>95 % break of UT for 5 seconds Mains power should be that of a typical hospital or commercial environment. If the user of the Tempus IC requires continued operation during power interruptions then the battery may be used for periods up to 6 hours or a UPS may be used. Magnetic field at the supply frequency (50/60 Hz) acc. to IEC 61000-4-8 3 A/m 3 A/m Magnetic fields at the supply frequency should conform to the typical values as they occur in the business or clinic environment.
Tempus IC User/Operator Manual- USA Page 119 41-1025-03A Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines NOTE UT is the AC mains voltage before the use of testing levels Manufacturer's Declaration - Electromagnetic Interference Resistance (Tab. 204 according to DIN EN 60601-1-2) The Tempus IC is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment. Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidelines Conducted RF disturbances acc. toIEC61000-4-6 Radiated RF disturbances acc. to IEC61000-4-3 3 Vrms 150 KHz to 80 Mhz 3 V/m 80 MHz to 2,5 GHz 3Vrms 3Vrms 2Hz signals may appear on the ECG trace in the range 109-114MHz, 193-205MHz, 216-228MHz. Portable and mobile RF communications equipment should be used no closer to the device including the cables than it is recommended by the equation for the frequency. Recommended safety distance: d = 1.2√P d = 1.2√P for 80MHz to 800 MHz d = 2.3√P for 800 MHz to 2,5 GHz P is the nominal power of the transmitter in watt (W) according to the specifications of the transmitter manufacturer; d is the recommended safety distance in meters (m). The field strength of stationary transmitters should be lower than the Compliance level for all frequencies according to a testing on location. Disturbances are possible near devices with the following symbol: NOTE 1: For 80 Hz and 800 MHz the higher frequency range is valid. NOTE 2: These guidelines may not be applicable for all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects and people. a) The field strength of stationary transmitters such as fixed parts of cellular phones and mobile radio sets, amateur radio stations, AM and FM radio and television cannot be determined exactly in theory. To detect the electromagnetic environment in regard to stationary transmitters a study of the location should be considered. If the measured field strength at the location where the device is being used exceeds the Compliance level above the device should be watched to verify the proper functions. If unusual features are watched additional actions might be necessary such as a modified orientation or another location of the device. b) For the frequency range of 150 kHz to 80 MHz the field strength should be lower than 10 V/m.
Tempus IC User/Operator Manual- USA Page 120 41-1025-03A Recommended Safety Distances between portable and mobile RF Telecommunication Devices and the TEMPUS IC (Tab. 206 according to DIN EN 60601-1-2) The TEMPUS IC is intended for use in an electromagnetic environment with controlled RF disturbances. The user of the device can help to avoid electromagnetic disturbances by keeping the minimum distance between portable and mobile telecommunication devices (transmitters) and the device - depending on the output power of the telecommunication devices as described below. Safety Distance Depending on the Frequency in m Nominal power of the transmitter W 150 kHz to 80 MHz d = 1.2√P 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2,5 GHz d = 2.6√P 0,01 0.12 0.12 0.23 0,1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters with a maximum nominal power not mentioned above: To detect the recommended safety distance use the equitation in the corresponding column. P is the maximum nominal power of the transmitter in watt (W) according to the specifications of the transmitter manufacturer. NOTE 1: For 80 Hz and 800 MHz the higher frequency range is valid. NOTE 2: These guidelines may not be applicable for all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects and people.
Tempus IC User/Operator Manual- USA Page 121 41-1025-03A 14 Symbols Used on the Tempus IC The following symbols are used on the Tempus IC: Symbol Description Defibrillation proof type CF applied part, Type BF applied part. The thermometer is not proof against the effects of a cardiac defibrillator discharge. Attention, consult accompanying documents Battery Charge indicator – flashes green when the battery is on charge Battery power level System power on/off (push/push) Date of manufacture, where the year that the item was manufactured is represented by the year and then the month e.g. 2002 06 is June 2002. Single use device only, discard item after use IPX6 The device is proof against a hose according to IEC529 YYYY - MM
Tempus IC User/Operator Manual- USA Page 122 41-1025-03A Symbol Description The device has been declared by the manufacturer to be in accordance with the requirements of the European Union Medical Devices Directive 93/42/EEC as transposed by UK national legislation. Shelf life, where the time that the unit must be used by is represented by the year and then the month e.g. 2004 06 is June 2004. LOT YYYY - MM Where the year that the item was manufactured as a part of a larger batch is represented by the year and then the month e.g. 2002 06 is June 2002. This product should not be discarded as general waste and must be disposed of as electrical and electronic waste. Communications connections WiFi connection mode to response centre Bluetooth® connection to medical modules Battery Connection – to indicate positive terminal polarity Global Positioning System (GPS) YYYY - MM
Tempus IC User/Operator Manual- USA Page 123 41-1025-03A Symbol Description Global System for Mobile (GSM) communications Headset connector Power Status (green indicates mains power is connected) Camera Backlight Device contains wireless transmitters DC connector
Tempus IC User/Operator Manual- USA Page 124 41-1025-03A 15 End User License Agreement This license covers RDT’s Tempus IC software. Warning: The software contained herein is protected by copyright law and international treaties. Unauthorized reproduction, distribution or reverse engineering of this program, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. You acknowledge that you will read and adhere to the user manual and ensure that users receive proper training from RDT or an appropriately trained individual. You also acknowledge that you will maintain the software by installing new software updates supplied by RDT within 5 working days of receiving or being notified of them. License: You may transfer the program and license to another party if the party agrees to accept the terms and conditions of this agreement. You will not share the program with other parties and will keep the program and details of its functions confidential. You will ensure that access to the software and use of it will be restricted to properly trained and authorized personnel only. You will not try to copy or reverse engineer the software. The Tempus IC operates over third-party communications links, such as telephone lines, GSM or satellite links and the Internet. RDT does not accept liability for the failure of these links to reliably transmit information from RDT’s products. Users are reminded that it is their responsibility to ensure that GSM network and other communications contracts are maintained and suitably setup and configured for the areas in which they need to be used. In order to function correctly Tempus IC needs to operate over a communications link such as satellite communications, GSM or a telephone line and other types of links. It is your responsibility to maintain these communications links. Such links may have security or other measures implemented on them such as firewalls. It is your responsibility to ensure that any such firewalls or other elements of the communication link are configured correctly to allow data from Tempus IC to communicate over said link. RDT does not accept any responsibility for failure to transmit data or to transmit data reliably over such links if they have not been configured correctly. Support on configuring such links can be obtained from RDT upon request. Neither the Tempus IC or RDT are a "covered entity" under the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder ("HIPAA"). As a result, HIPAA does not apply to the transmission of health information by RDT or Tempus IC to any third party. The software gives users the ability to share and transmit medical data with third parties. Such activities are entirely the responsibility of the user. RDT owns all proprietary rights to the Tempus IC. RDT gives you a personal, revocable, non-assignable, and non-exclusive license to use the Tempus IC. Limited Warranty and Remedies: In no event shall RDT or its distributors or agents, be liable for any damages resulting from loss of data, loss of revenue or for any incidental or consequential damages incurred arising out of or relating to the use of this software product. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. This warranty gives you specific legal rights and you may have other rights that vary from region to region. RDT’s Terms and Conditions apply. RDT and its distributors make no representations with respect to the merchantability or fitness of the Tempus IC software and the product is supplied "as is", without any warranty of any kind. Further, RDT reserves the right to revise its publications and program(s) without obligation to notify customer of such a revision. You acknowledge that you have read this agreement, understood it, and agree to be bound by its terms and conditions. Failure to enforce any provision will not constitute a waiver of that provision. If any provision is found unenforceable, it and any related provisions will be interpreted to best accomplish the unenforceable provision's essential purpose.
Tempus IC User/Operator Manual- USA Page 125 41-1025-03A This agreement is governed by UK law. The exclusive venue for any dispute relating to this agreement is London UK. You and RDT consent to the personal jurisdiction of these courts. Nothing in this agreement limits either party's ability to seek equitable relief. Pocket Medic This license covers QRS Pocket Medic software. Warning: The software contained herein is protected by copyright law and international treaties. Unauthorized reproduction, distribution or reverse engineering of this program, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. License: · You may use this program on a single computer. · You may make a back up copy of this software in support of your use of this software. · You may transfer the program and license to another party if the party agrees to accept the terms and conditions of this agreement. If you transfer the software you must turn over all copies of the software to the same party or destroy any copies not transferred. Limited Warranty and Remedies: In no event shall QRS Diagnostic, LLC or the distributors of "Pocket Medic", be liable for any damages resulting from loss of data, loss of revenue or for any incidental or consequential damages incurred arising out of or relating to the use of this software product. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. This warranty gives you specific legal rights and you may have other rights that vary from region to region. QRS Diagnostic, LLC and its distributors MAKE NO REPRESENTATIONS with respect to the merchantability or fitness of "Pocket Medic" and the product is sold "as is", without any warranty of any kind. The only exception is the 60-day warranty extended for replacement of defective disks. Further, QRS Diagnostic, LLC, reserves the right to revise its publications and program(s) without obligation to notify customer of such a revision. You acknowledge that you have read this agreement, understood it, and agree to be bound by its terms and conditions; you further agree that it is the complete and exclusive statement of the agreement between us which supercedes any proposal or prior agreement, oral or written, and any other communications between us relating to the subject matter of this agreement.
Tempus IC User/Operator Manual- USA Page 126 41-1025-03A 16 Change History Page/Section Change Date/Issue N/A First release 00 5 Clarified that this manual now intended for use by US customers only and acknowledging the registered trademarks of MyGlucoHealth. 01 58 Removed text, i.e. Note that the glucometer function is not yet licensed for use in Canada, as it has been approved for use Canada. 01 3, 5, 12-13, 32, 37-47, 86-88, 94, 110-111. Addition of a Sennheiser™ VMX200 wireless headset. 02 94 Addition of a Bag Front Pocket Clips to the spares list (in section 11) 02 Section 2.4.1 and 13.1.9 FCC ID Information and SAR performance updated 03

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