Remote Diagnostic Technologies TEMPUSIC-1 Tempus IC Patient Monitor User Manual

Remote Diagnostic Technologies Ltd. Tempus IC Patient Monitor

User manual

Tempus ICUser/Operator ManualPart number 41-1001Copyright 2009, RDT Ltd. UKDate of Issue: 6 November 2009
Tempus IC User/Operator ManualPage I 41-1001-04Contents1 INTRODUCTION................................................................................................................51.1 Manufacturer's Address.............................................................................................51.2 CE Statement.............................................................................................................51.3 FDA Prescription Statement......................................................................................51.4 Proprietary Notice ......................................................................................................51.5 Use of This Manual....................................................................................................61.6 Patent Claims.............................................................................................................61.7 Limited Warranty........................................................................................................61.7.1 Service Support and Returns ............................................................................................................... 62 WARNINGS AND CAUTIONS ..........................................................................................72.1 EMC Statement..........................................................................................................72.2 Indications for Use .....................................................................................................72.3 Contraindications .......................................................................................................72.4 Warnings, Cautions and Notes..................................................................................82.4.1 Tempus IC Warnings, Cautions and Notes......................................................................................... 82.4.2 LoFlo Sidestream Capnometer - Warnings, Cautions, & Notes...................................................... 152.4.3 Pulse Oximeter Sensor - Warnings, Cautions, & Notes .................................................................. 162.4.4 ECG Recorder Sensor - Warnings, Cautions, & Notes ................................................................... 172.4.5 The Blood Pressure Monitor - Warnings, Cautions, & Adverse Reactions.................................... 173 INTRODUCTION TO THE TEMPUS IC..........................................................................193.1 Product Description and List of Features................................................................194 INTRODUCTION TO THE TEMPUS IC..........................................................................204.1 Tempus IC Device....................................................................................................204.1.1 Tempus IC Front.................................................................................................................................. 204.1.2 Tempus IC Base .................................................................................................................................. 204.1.3 Tempus IC Rear................................................................................................................................... 214.1.4 Tempus IC Sides ................................................................................................................................. 215 USING THE TEMPUS IC.................................................................................................235.1 Controlling the Tempus IC.......................................................................................235.2 Explanation of the Tempus IC Screen.....................................................................275.2.1 Status Bar – Clock (Time Stamp)....................................................................................................... 275.2.2 Status Bar – Bluetooth®Indicator....................................................................................................... 275.2.3 Status Bar - WiFi Indicator.................................................................................................................. 285.2.4 Status Bar – GSM/GPRS Indicator.................................................................................................... 285.2.5 Instrument Readings ........................................................................................................................... 285.2.6 Instrument Status Indicators ............................................................................................................... 295.3 Device Sensors........................................................................................................295.3.1 Pulse Rate and Oxygen Saturation (SpO2)....................................................................................... 295.3.2 Blood Pressure..................................................................................................................................... 295.3.3 Electrocardiograph (ECG)................................................................................................................... 295.3.4 End Tidal CO2(ETCO2) and Respiration Rate................................................................................ 305.4 Digital Camera..........................................................................................................305.5 Voice and Data Communications............................................................................30
Tempus IC User/Operator ManualPage II 41-1001-046 SETTING UP....................................................................................................................316.1.1 Unpacking the Tempus IC ..................................................................................................................316.2 Tempus IC Bag ........................................................................................................316.3 Switching On............................................................................................................336.3.1 Immediately after Switching On.......................................................................................................... 337 ESTABLISHING COMMUNICATION WITH THE RESPONSE CENTRE.....................357.1 Making the Phone Connection ................................................................................357.2 Fitting the Headset and Making the Voice Connection...........................................367.2.1 Using the Wireless Headset ............................................................................................................... 377.3 Connection Status Indicators...................................................................................407.3.1 Dialling Order and Indicators When Dialling ..................................................................................... 417.4 Communications Modes ..........................................................................................427.4.1 Changing Modes.................................................................................................................................. 427.4.2 Using Available Modes........................................................................................................................ 427.4.3 Changing the Connection Mode......................................................................................................... 428 TAKING MEDICAL READINGS......................................................................................458.1 Blood Pressure and Pulse Oximeter.......................................................................458.1.1 Understanding the Pulse Oximeter Results...................................................................................... 478.1.2 Understanding the Blood Pressure Results ......................................................................................478.1.3 Blood Pressure Monitor Error iAssist Help Process......................................................................... 488.2 Electrocardiograph (ECG).......................................................................................488.2.1 Monitoring an ECG .............................................................................................................................. 508.2.2 Recording an ECG............................................................................................................................... 518.3 Capnometer..............................................................................................................528.3.1 Understanding the Capnometer Results ........................................................................................... 538.4 Thermometer............................................................................................................548.4.1 Using the Thermometer ...................................................................................................................... 568.4.2 Understanding the Thermometer Results ......................................................................................... 568.5 Glucometer...............................................................................................................578.5.1 Testing the Glucometer....................................................................................................................... 598.5.2 Understanding the Glucometer Results ............................................................................................ 598.6 Digital Camera..........................................................................................................608.6.1 Annotation of Digital pictures .............................................................................................................. 638.7 Interacting with the Response Centre.....................................................................638.7.1 The Response Centre ......................................................................................................................... 638.7.2 Remote Viewing and Control.............................................................................................................. 648.8 Recording Data Off-line and Transmitting On-line..................................................648.9 GPS Location...........................................................................................................658.10 Actions after Use – Turning the Tempus IC Off......................................................668.10.1 Logging Maintenance Requirements ............................................................................................ 679 AFTER USING THE TEMPUS IC....................................................................................699.1 Cleaning the Tempus IC..........................................................................................699.1.1 Cleaning the Thermometer ................................................................................................................. 699.1.2 Cleaning the Glucometer ....................................................................................................................699.2 Cleaning and Re-packing Help Screen...................................................................709.3 Single-Use Devices..................................................................................................7110 MAINTENANCE, SERVICING AND TROUBLESHOOTING.........................................7210.1 General.....................................................................................................................7210.2 Battery Management................................................................................................72
Tempus IC User/Operator ManualPage III 41-1001-0410.2.1 The Battery ...................................................................................................................................... 7210.2.2 Removing the Battery from the Tempus IC .................................................................................. 7510.2.3 Charging the Battery ....................................................................................................................... 7610.2.4 Tempus IC Battery Shelf Life ......................................................................................................... 7810.2.5 Other Tempus IC Batteries............................................................................................................. 7810.2.6 Disposal of Batteries ....................................................................................................................... 8010.3 Troubleshooting .......................................................................................................8110.3.1 Errors ................................................................................................................................................ 8110.3.2 Thermometer Errors........................................................................................................................ 8210.3.3 Glucometer Errors ........................................................................................................................... 8311 SPARES LIST..................................................................................................................8511.1 Spares List of the Tempus IC..................................................................................8512 CONFIGURING THE TEMPUS IC...................................................................................8613 SPECIFICATIONS AND STANDARDS..........................................................................8913.1 Specifications...........................................................................................................8913.1.1 Non-invasive Blood Pressure......................................................................................................... 8913.1.2 ECG Recorder ................................................................................................................................. 8913.1.3 ETC02Sensor .................................................................................................................................. 9013.1.4 Sp02Sensor ..................................................................................................................................... 9213.1.5 Thermometer ................................................................................................................................... 9313.1.6 Glucometer ...................................................................................................................................... 9413.1.7 Environmental Specifications ......................................................................................................... 95Temperature & Altitude:......................................................................................................95Temperature Variation:.......................................................................................................95Humidity:..............................................................................................................................95Operational Shocks & Crash Safety:..................................................................................96Vibration:.............................................................................................................................96Explosion Proofness:..........................................................................................................96Water Proofness:................................................................................................................96Fluids Susceptibility: ...........................................................................................................96Sand & Dust:.......................................................................................................................96Fungus Resistance:............................................................................................................96Salt Spray:...........................................................................................................................96Magnetic Effect: ..................................................................................................................97Power Input:........................................................................................................................97Voltage Spike:.....................................................................................................................97Audio Frequency Conducted Susceptibility – Power inputs:.............................................97Induced Signal Susceptibility:.............................................................................................97Radio Frequency Susceptibility (Radiated & Conducted): ................................................97Emission of Radio Frequency Energy:...............................................................................97Lightning Induced Transient Susceptibility:........................................................................97Lightning Direct Effects:......................................................................................................97Icing:....................................................................................................................................97ESD:....................................................................................................................................97Fire and Smoke Hazards:...................................................................................................9713.1.8 Miscellaneous Features and Specifications ................................................................................. 9813.1.9 Communications.............................................................................................................................. 9813.1.10 Tempus IC Device Classification.................................................................................................10313.1.11 Standards Compliance .................................................................................................................104
Tempus IC User/Operator ManualPage IV 41-1001-0414 SYMBOLS USED ON THE TEMPUS IC.......................................................................10915 END USER LICENSE AGREEMENT............................................................................11216 CHANGE HISTORY.......................................................................................................114
Tempus IC User/Operator ManualPage 5 41-1001-041 Introduction1.1 Manufacturer's AddressThe Tempus IC is designed and manufactured by:RDT LimitedThe Old Coach HouseThe AvenueFarleigh WallopBasingstokeHampshireRG25 2HTUKTel +44 (0) 1256 362 400Fax +44 (0) 1256 362 415Email sales@rdtltd.comwww.rdtltd.com1.2 CE StatementMarking by the symbol indicates compliance of this device to the Medical DevicesDirective 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 theNotified Body who certify RDT’s quality system.A Declaration of Conformity in accordance with the above regulations has been made and is onfile with RDT at the address in section 1.1.1.3 FDA Prescription StatementFederal law (USA) restricts the use or sale of this device by, or on the order of, a physician.1.4 Proprietary NoticeInformation contained in this document is copyright © 2009 by Remote DiagnosticTechnologies Limited ('RDT') and may not be reproduced in full or in part by any means or inany form by any person without prior written permission from RDT.The purpose of this document is to provide the user with adequately detailed information toefficiently install, operate, maintain and order spare parts for the Tempus IC. Every effort hasbeen made to keep the information contained in this document current and accurate as of thedate of publication or revision. However, no guarantee is given or implied that the document iserror free or that it is accurate with regard to any specification. RDT reserves the right tochange 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 nameor mark is under license.BodyTel®and GlucoTel®are protected by registered trademarks and trademark applications ofBodyTel Europe Gmbh.
Tempus IC User/Operator ManualPage 6 41-1001-041.5 Use of This ManualThe instructions and safety precautions provided in this manual must be observed during allphases of the operation, usage, service or repair of the Tempus or its accessories. Failure tocomply 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. RDTLtd assumes no liability for customer failure to comply with the information contained in thismanual.Users of Tempus IC and its accessories are advised to convey the following safety informationto operating personnel and to incorporate applicable information into their own internalliterature where necessary.1.6 Patent ClaimsRDT has applied for patents covering Tempus IC and its communications technology in thefollowing jurisdictions:Patents Pending (US No.2006/0287586 EP 1734458 A & other areas).1.7 Limited WarrantyRemote Diagnostic Technologies Limited ('RDT') warrants each new Tempus IC to be freefrom defects in workmanship and materials under normal conditions of use and service. Fordetails please refer to the Terms and Conditions of Sale. Consumable items are expresslyexcluded from this Warranty. RDT's sole obligation under this warranty will be to repair or (atRDT's option) replace products that prove to be defective during the warranty period. Theforegoing shall be the sole warranty remedy. Except as set forth herein, RDT makes nowarranties, either expressed or implied, including the implied warranties of merchantability andfitness for a particular purpose. The warranty shall be void if Tempus IC is in any way modifiedor 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 warrantyis not assignable.Full terms and conditions of sale are available from RDT and are provided with your orderconfirmation.1.7.1 Service Support and ReturnsRepairs made under warranty to Tempus IC must be made by the manufacturer. If Tempus ICrequires repair or return for any reason, please contact your local distributor or RemoteDiagnostic 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 beenprovided with an RMA number. When calling, please be ready to quote the serial number ofTempus IC.The Tempus IC is designed to be as maintenance free as possible. The only user replaceableand 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 thismanual, stop using the device immediately and switch the device off immediately. Contact themanufacturer or distributor at once. Do not attempt any kind of corrective action and do notconnect the device to a patient.
Tempus IC User/Operator ManualPage 7 41-1001-042 Warnings and Cautions2.1 EMC StatementThe 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 electricalmedical equipment in terms of its levels of emitted electromagnetic radiation and itssusceptibility to electromagnetic radiation from other devices.In addition, the Tempus IC has been tested according to the requirements of RTCA DO160-Esection 21 category M.It should be noted that the Tempus IC may be affected by high levels of stray EM radiationfrom other electronic devices (even those which comply with relevant CISPR emissionstandards) that are being used in close proximity to it.As required by international medical device standards, the Tempus IC is intended for use inelectromagnetic environments of 6kV static contact (8kV air discharge) and magnetic fieldsof 3A/m (50/60Hz). The Tempus IC is proof against radiated RF emissions from 80MHz to2.5GHz to a level of 3V/m. In the event that the Tempus IC will be used in environments withRF levels exceeding this, please contact RDT for further information.2.2 Indications for UseThe Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sickwhen they are in a location remote from immediate medical assistance. The device allows theUser to take vital signs data from a patient and to transmit that data to medical professionalslocated at the response centre elsewhere. Typical examples are remote land, sea or airlocations.The Tempus IC is intended primarily to be used by medically unqualified people who havereceived basic training in the use of the device. Medical expertise is provided throughcommunication with the Response Centre which would be staffed by physicians who wouldadvise 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 mayor may not be present but where remote physician support is required.The Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg inweight).2.3 ContraindicationsThe Tempus IC is not intended to be used on extremely small or extremely large patients; thislimit 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 neonataluse. The device is not an apnoea monitor.The Tempus IC is not intended to be used in strong magnetic or electro-magnetic fields whichare generated for medical purposes e.g. MRI. The Tempus is not for use with electro-cauterydevices.The Tempus IC is not intended to allow a lay user to make any clinical decision for treatment ordiagnosis.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 inshort, 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 ManualPage 8 41-1001-042.4 Warnings, Cautions and NotesKEYWORD DEFINITIONWARNING 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 moreeffective or convenient.2.4.1 Tempus IC Warnings, Cautions and NotesWARNINGIt is essential to switch off the Tempus IC between applying it todifferent patients in order to ensure patient records remainseparate.WARNING: The use of the symbol indicates that the user must read the user manualbefore using the product.WARNING: Only connect Tempus IC to IT and communications systems which arecompliant with the relevant IEC standard e.g. IEC60950. Signal input andoutput connectors are only for connection to equipment complying with relevantIEC 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 accessibleconductive 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 areno 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 thesensors in liquid as it may cause sensor damage which may result ininaccurate readings.WARNING: ELECTRICAL SHOCK HAZARD when covers are removed. Do not removecovers. Refer servicing to qualified personnel authorised by RDT.WARNING: Device must be used in conjunction with clinical signs and symptoms. Deviceis only intended to be an adjunct in patient assessment.WARNING: Attention should be paid to the following EMC information prior to installing orusing the device.WARNING: Verify normal operation if utilizing device adjacent to or stacked with otherelectrical equipment.WARNING: Portable and mobile Radio Frequency (RF) communication equipment mayinterfere 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 orequivalent IEC standards may result in increased emissions or decreasedimmunity of device.
Tempus IC User/Operator ManualPage 9 41-1001-04WARNING: Follow precautions for electrostatic discharge (ESD) and electromagneticinterference (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 itsaccessories may be interfered with by other devices which operate at the samefrequencies.WARNING: The sensors of the Tempus IC are only for contact with intact and undamagedskin.WARNING: Any device or accessory that has been dropped, damaged or subjected toharsh or extreme environmental conditions should be inspected by qualifiedservice 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. TheTempus IC is protected against defibrillator discharge but rate meters anddisplays may be temporarily affected during defibrillator discharge but willrapidly recover.WARNING: There is no defibrillator synchronisation output on the device. Make noconnections between the device and a defibrillator.WARNING: Device will not operate effectively on patients who are experiencingconvulsions or tremors.WARNING: Device is not for apnoea detection. Device has not been tested or validated foruse in apnoea detection.WARNING: Misuse or improper handling of the device or its sensors or cables can causedamage which may lead to equipment failure or inaccurate readings.WARNING: Misuse or improper handling of the device (its sensors or cables) can causedamage 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 thebatteries in any liquid. Remove batteries when discharged.WARNING: Only use rechargable batteries and battery chargers specified by RDT.WARNING: Ensure patient cabling or tubing is carefully routed on device to reduce thepossibility of patient entanglement or strangulationWARNING: All numerical, graphical and interpretive data should be evaluated with respectto the patient's clinical and historical pictureWARNING: Do not attempt to insert any connections from the Tempus IC (including patientcables) directly into an electrical outletWARNING: Explosion Hazard: DO NOT use the Tempus IC in the presence of flammableanesthetics or other flammable gasses. Use of the Tempus IC in suchenvironment may present an explosion hazard.WARNING: Electrical Shock Hazard: Always disconnect the LoFlo sidestream Capnometerbefore cleaning. Do NOT use if it appears to have been damaged. Referservicing to qualified service personnel.WARNING: Failure of Operation: If the Tempus IC fails to respond as described in this userguide; 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 systemperformance leading to a user or patient hazard. Performance is notguaranteed 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
Tempus IC User/Operator ManualPage 10 41-1001-04resulting in patient injury or death. Inspect each sensor. If a sensor appearsdamaged, do not use it. Use another sensor or contact your authorized repaircenter for help.WARNING: Using a damaged patient cable may cause inaccurate readings, possiblyresulting in injury or death. Inspect the patient cable. If the patient cableappears damaged, do not use it. Contact your authorized repair center forhelp.WARNING: The USB connection must only be connected to non-mains poweredperipherals (such as a mouse or keyboard) or to interface accessories providedby RDT (such as the USB-Serial Cable pn 01-1022). Any connections made tothe USB port must be to medical or IT peripherals or communications systemswhich comply with the applicable IEC safety standard (i.e. IEC60601-1 orIEC60950). Any connection arrangements must be made in a mannercompliant with IEC60601-1-1.CAUTION: Do not disassemble the device. There are no user-serviceable parts inside.Refer servicing to the manufacturer. Changes or modifications not expresslyapproved by RDT could void the user’s authority to operate the equipment.CAUTION: Repairs or service activity not detailed in this manual or in accompanyingdocuments must only be undertaken by personnel trained or authorized byRDT.CAUTION: Autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid maycause 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 manualbefore using the device.CAUTION: The Tempus IC may not operate correctly if used or stored outside the relevanttemperature or humidity ranges described in the performance specifications ofthis 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 operatormust be thoroughly familiar with the information in this manual before using thedevice.CAUTION: The device is not intended to, and does not, sound alarms for physiologicalparameters.CAUTION: In the event that the device displays an error that is not described within thismanual 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 notcontinue 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 timefor drying before operating. Take care to ensure that water or liquids are notspilt 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 vitalsign(s) by an alternative method and then check the monitor for properfunctioning.CAUTION: Follow local government regulations and recycling instructions regardingdisposal and recycling of device and device components.
Tempus IC User/Operator ManualPage 11 41-1001-04CAUTION: The Tempus IC and its accessories use different types of batteries whichincludes rechargeable and non-rechargeable types. If any battery fails to holda charge or otherwise becomes inoperable, the battery should be replaced andthe old battery should be disposed of properly. RDT cannot dispose of usedbatteries. Dispose of batteries in accordance with applicable regulations whichvary 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-profitprofit organisations, mandated by local governments or organised on avoluntary basis by professionals).CAUTION: Pressing buttons and touch screen with sharp or pointed instruments maypermanently damage the buttons and touch screen. Only fingers should beused to press these keys.CAUTION: Do not reconnect the headset to its docking pin when the main battery is verylow or flat (less than 10% charge – as represented by a single flashing red LEDon the battery charge indicator). Doing this could reduce the battery chargeinto a “deep discharge” state (where no battery lights come on).CAUTION: Only connect the device to communications systems which are compliant withrelevant international safety standards e.g. IEC60950 for IT andtelecommunications equipment. Only connect the device to communicationssystems which it is intended to be used with.CAUTION: Do not touch electrically live parts of other electrical systems while touching thepatient.CAUTION: Use of monitoring during continuous nebulised medication delivery will result indamage to the device which is not covered by the warranty. Disconnect thecapnometer sample line from the device, or switch off the device, duringmedication delivery.CAUTION: Observe proper battery polarity (direction) when replacing batteries. Thebatteries slide easily into place when correctly oriented and should not beforced.CAUTION: The mobile RF communications equipment contained within the device and itsaccessories can affect other medical devices that are in close proximity to thedevice.CAUTION: Use of the RF communications equipment contained in the device and itsaccessories may be prohibited in a number of areas. These include: on aircraftin-flight (including during take-off and landing), near defibrillators (that are inuse), near other electronic medical devices and in hospitals.CAUTION: In addition, the use of the RF communications equipment contained in thedevice and its accessories may be prohibited in explosive atmospheres e.g. infuelling areas, near fuel or chemical transfer or storage areas and in areascontaining 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 itsaccessories may cause interference with some implanted pacemakers andother medically implanted equipment.A minimum distance of 2.3m (7.5 feet) must be maintained between the deviceand its accessories (containing RF communications equipment) and othermedical equipment (including implantable medical devices such as defibrillatorsand pacemakers). Note that if such medical equipment has an electromagneticinterference immunity level of less than 3V/m (or 10V/m for implantabledevices), this distance should be increased in line with the requirements ofIEC60601-1-2:2007.
Tempus IC User/Operator ManualPage 12 41-1001-04If 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 physiologicaldata. After the data recording session is completed, move the device at least2.3 m away from the patient, and then use it normally to communicate with thebase station. Otherwise, radiofrequency radiation from the device (up to63mW) may adversely impact the implantable pacemaker in the patient. If thepatient's implantable device has an immunity level less than 10 V/m, theseparation has to be greater than 2.3 mIf you suspect interference is being caused, disconnect the connection to theresponse centre by pressing . Examples of interference could includevisible interference on equipment displays, audible interference e.g. buzzing,from speakers of other equipment, or equipment unexpectedly changing statee.g. functions starting or stopping. Examples of visible interference on a PCdisplay are shown below:Example of a PC display with no interferenceExample of a PC display with interference
Tempus IC User/Operator ManualPage 13 41-1001-04This equipment complies with FCC RF radiation exposure limits set forth for anuncontrolled environment. The antenna(s) used for this transmitter must beinstalled to provide a separation distance of at least 20 cm from all persons andmust not be co-located or operating in conjunction with any other antenna ortransmitter except as defined in the FCC filingCAUTION: When using the device with portable satellite terminals such as Iridiumhandsets or GAN terminals, ALWAYS ensure that the terminal is provided withany applicable data adaptors and is set up to support data calls. It isrecommends that Users thoroughly familiarise themselves with the operationtheir satellite terminals and perform a test connection BEFORE going into thefield 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 ofinterference from the output beam from the antenna of the terminal with theoperation of the device, ALWAYS ensure that the device is situated at least 6mbehind the face of the antenna. Since the power of the GAN terminal’s beam ishigh (25W apx), care should be taken to ensure that the antenna remains fixedand to maintain the device away from the face (and therefore the beam) of theantenna.CAUTION: Do not reconnect the headset to its docking pin when the main battery is verylow or flat (less than 10% charge – as represented by a single flashing red LEDon the battery charge indicator). Doing this could reduce the battery chargeinto a “deep discharge” state (where no battery lights come on).CAUTION: RF energy may affect some electronic systems in motor vehicles, such as carstereo, safety equipment, etc. Check with your vehicle manufacturer’srepresentative to be sure that your product will not affect the electronic systemin your vehicle.CAUTION: Do not use the Tempus IC’s Bluetooth®or WiFi communications on-board anyaircraft where its use is prohibited.CAUTION: Do not use the Tempus IC during take-off or landingNOTE: If all the battery lights remain off when the battery button is pressed, the batterymay be in a “deep discharge” state. The battery is not damaged when in thisstate but will require an extended period on a charger (additional 2-3 hours) inorder to restore normal operation.NOTE: Important! The Tempus IC is intended for use in the electromagneticenvironment(s) specified in this manual. Users of this equipment should ensurethat it is used in such environment(s).NOTE: The Tempus IC or its accessories contain no user serviceable parts except asdetailed by this manual or accompanying documents. Refer service to qualifiedservice 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 ofconducted electrical transients or strong electromagnetic or radio frequencysources such as electrosurgery and electrocautery equipment, HF radiotransmission 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 analysiswas performed to meet the requirements of EN14971 and IEC60601-1-4.NOTE: Each external connection and part of the device is electrically isolated.NOTE: Performance and safety test data are available on request from the address insection 1.1.
Tempus IC User/Operator ManualPage 14 41-1001-04NOTE: Device complies with Part 68 of the US FCC Rules and the requirementsadopted by ACTA . The device is labelled with, among other information, aproduct identifier in the format US:AAAEQ###TXXXX. If requested, thisnumber must be provided to the telephone company.NOTE: A plug and jack used to connect the device to the premises wiring andtelephone network must comply with the applicable FCC Part 68 rules andrequirements adopted by ACTA. A compliant telephone cord and modular plugis provided with this product. It is designed to be connected to a compatiblemodular jack that is also compliant.NOTE: The REN is used to determine the number of devices that may be connected toa telephone line. Excessive RENs on a telephone line may result in the devicesnot ringing in response to an incoming call. In most but not all areas, the sum ofRENs should not exceed five (5.0). To be certain of the number of devices thatmay be connected to a line, as determined by the total RENs, contact the localtelephone company. For products approved after July 23, 2001, the REN forthis product is part of the product identifier that has the formatUS:AAAEQ##TXXXX. The digits represented by ## are the REN without adecimal point (e.g., 03 is a REN of 0.3). For earlier products, the REN isseparately shown on the label.NOTE: If the device causes harm to the telephone network, the telephone companywill notify you in advance that temporary discontinuance of service may berequired. But if advance notice isn't practical, the telephone company will notifythe customer as soon as possible. Also, you will be advised of your right to filea 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. Ifthis happens the telephone company will provide advance notice in order foryou to make necessary modifications to maintain uninterrupted service.NOTE: If the equipment is causing harm to the telephone network, the telephonecompany may request that you disconnect the equipment until the problem isresolved.NOTE: Connection to party line service is subject to state tariffs. Contact the statepublic utility commission, public service commission or corporation commissionfor information.NOTE: If your home or area of installation has specially wired alarm equipmentconnected to the telephone line, ensure the installation of the device does notdisable your alarm equipment. If you have questions about what will disablealarm 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 areearthed. Using a non-earthed power supply with satellite terminals will causeinterference on the ECG trace. Earthed power supplies will always have athree pin connector to plug the mains lead into, non-earthed power supplies willalways have the following symbol on their label . In addition, whenpurchasing any replacement power supplies for satellite terminals, alwaysensure 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 andis approved to EN/IEC60950 (safety standard). Advice on this matter may besought from RDT if needed.NOTE: GSM usage is restricted by the network availability, roaming agreements andlocal provision of circuit mode connections.
Tempus IC User/Operator ManualPage 15 41-1001-04NOTE: Users who own multiple device units should note that their device are likely tobe pre-configured for different aircraft, yachts or other locations according tothe customer’s needs. Consequently different device units owned by one Usermay 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 ifspecific device is configured for specific applications. Alternatively pleasecheck with a technical contact at RDT for confirmation.NOTE: Users should not put the device into service until they have been trained in itsuse and also (where appropriate) the device has been commissioned on theiraircraft, 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 decompressionNOTE: Device should be returned for service if it is subject to rough handling and IPsealing is needed to be relied upon.NOTE: The Tempus IC’s water ingress seals are warranted for 1 year from the date ofmanufacture.NOTE: The device specifications are subject to change without notice.NOTE: It is recommended that the device is connected to the response centre everymonth for a test patch.NOTE: The iAssist help processes on your Tempus IC may differ from the exampleiAssist help process used in this manual; however the process always followsthe same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.NOTE: For optimum performance of the wireless communications, please make surethat there is no metal surrounding the Tempus IC.NOTE: Overbending the folding foot or RapdiPak clip could cause them to bedamaged. Do not over-bend these items.NOTE: Take care when repacking cables to ensure they cannot be snagged ordamaged in the RapidPak clip and the folding foot.NOTE: The Tempus IC should be repacked following the relevant instructions. Lost ordamaged cables and accessories should be replaced with spares ordered fromRDT.2.4.2 LoFlo Sidestream Capnometer - Warnings, Cautions, & NotesWARNING: 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 exteriorcondensation.WARNING: DO NOT use device on patients that can not tolerate the withdrawal of 50ml/min +/- 10 ml/min from the airway or patients that can not tolerate the addeddead 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 than32º F (0º C) or greater than 104º F (40º C).CAUTION: Remove the LoFlo sampling kit sample cell from the receptacle when not inuse.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 ManualPage 16 41-1001-04NOTE: Nitrous oxide, elevated levels of oxygen, helium , Xenon, halogenatedhydrocarbons, and barometric pressure can influence the CO2measurement..2.4.3 Pulse Oximeter Sensor - Warnings, Cautions, & NotesWARNING: Do not use this device in the presence of high EMI/RFI radiation. High EMI/RFIradiation may cause induced current to the SpO2sensor resulting in patientinjury.WARNING: This device may give inaccurate readings in the presence of strongelectromagnetic sources, such as electrosurgery equipment.WARNING: This device may give inaccurate readings in the presence of computedtomography (CT) equipment.WARNING: This device must be used in conjunction with clinical signs and symptoms. Thisdevice is only intended to be an adjunct in patient assessment.WARNING: Prolonged use or the patient’s condition may require changing the sensor siteperiodically. Change sensor site and check skin integrity, circulatory status, andcorrect alignment at least every 4 hours. Prolonged use may cause blisters,skin deterioration, and discomfort.WARNING: Incorrectly applied sensors may give inaccurate readings.WARNING: SpO2measurements 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, indocyaninegreen, indigo carmine, patent blue V (PBV), and fluorescein may adverselyaffect the accuracy of the SpO2reading.WARNING: Any condition that restricts blood flow, such as use of a blood pressure cuff orextremes in systemic vascular resistance, may cause an inability to determineaccurate pulse rate and SpO2readings.WARNING: Remove fingernail polish or false fingernails using the wipe provided beforeapplying SpO2sensors. Fingernail polish or false fingernails may causeinaccurate SpO2readings.WARNING: Significant levels of dysfunctional hemoglogins, such as carboxyhemoglogin ormethhemoglobin, will affect the accuracy of the SpO2measurement.WARNING: Tissue damage may result from overexposure to sensor light duringphotodynamic therapy with agents such as verteporphin, porfimer sodium andmetatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at leastevery hour and observe for signs of tissue damage. More frequent sensor sitechanges or inspections may be indicated depending upon the photodynamicagent 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 thesterilized sensor is placed on a patient.WARNING: Optical cross-talk can occur when two or more sensors are placed in closeproximity. It can be eliminated by covering each site with opaque material.Optical cross-talk may adversely affect the accuracy of the SpO2readings.WARNING: Obstructions or dirt on the sensor’s red light or detector may cause a sensorfailure or inaccurate readings. Make sure there are no obstructions and thesensor is clean.WARNING: Under certain clinical conditions, pulse oximeters may display dashes if unableto display SpO2and/or pulse rate values. Under these conditions, pulseoximeters may also display erroneous values. These conditions include, butare not limited to: patient motion, low perfusion, cardiac arrhythmias, high orlow pulse rates or a combination of the above conditions. Failure of theclinician to recognize the effects of these conditions on pulse oximeter readingsmay result in patient injury.
Tempus IC User/Operator ManualPage 17 41-1001-04CAUTION: Unplug the sensor from the monitor before cleaning or disinfecting to preventdamaging sensor or monitor, and to prevent user safety hazards.NOTE: SpO2averaging is the number of pulse beats over which the SpO2value isaveraged; pulse averaging is the number of seconds over which the pulsevalue 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, & NotesWARNING: The ECG device is not intended for use in a sterile environment. Do not use fordirect cardiac application.WARNING: The ECG device is reusableWARNING: Do not attempt to insert the ECG device (including patient cables) into anelectrical outletWARNING: The ECG is for resting recordings and should not be used in stress testingenvironmentsWARNING: Ensure electrodes are connected only to the patientWARNING: Conductive parts of electrodes and connectors, including neutral electrode,should not contact other conductive parts including earthWARNING: The Tempus IC is rated as being proof against the effects of a defibrillatordischarge. 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 theTempus IC.−Do not touch the patient during defibrillation−Do not touch the defibrillator’s paddle-electrode surface when discharging thedefibrillator−Keep defibrillation electrodes well clear of other electrodes or metal parts incontact with the patient−Do not touch the patient, bed, or any conductive material in contact with thepatient during defibrillation2.4.5 The Blood Pressure Monitor - Warnings, Cautions, & AdverseReactionsWARNING: This device should not be used when oscillometric pulses may be altered byother devices or techniques such as External Counterpulsation (ECP) or IntraAortic Balloon Pump Counterpulsation.WARNING: DO NOT use the Blood pressure monitor for any purpose other than specifiedin this manual.WARNING: DO NOT attach the cuff to a limb being used for IV infusions as the cuffinflation can block the infusion, potentially causing harm to the patient.CAUTION: Accuracy of any blood pressure measurement may be affected by the positionof the subject, his or her physical condition and use outside of the operatinginstructions detailed in this manual. Interpretation of blood pressuremeasurements 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 performin an improper fashion. Only use hoses provided by RDT.CAUTION: Incorrectly sized cuffs may cause measurement inaccuracy or errors.CAUTION: If the blood pressure cuff is on the same limb as a pulse oximeter probe, theoxygen saturation results will be altered when the cuff occludes the brachialartery.
Tempus IC User/Operator ManualPage 18 41-1001-04CAUTION: 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 mayresult in incorrect readings.CAUTION: When a cuff is going to be positioned on a patient for an extended length oftime, 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 edematouspatches of skin or mucous membranes and intense itching) caused by thefabric material of the cuff.CAUTION: Petechia (a minute reddish or purplish spot containing blood that appears in theskin) formation or Rumple-Leede phenomenon (multiple Petechia) on theforearm following the application of the cuff, which may lead to Idiopathicthrombocytopenia (spontaneous persistent decrease in the number of plateletsassociated with hemorrhagic conditions) or phlebitis (inflammation of a vein)may be observed.
Tempus IC User/Operator ManualPage 19 41-1001-043 Introduction to the Tempus IC3.1 Product Description and List of FeaturesColour 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 responseCentre, 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 atthe remote location.Tempus IC in UseThe Tempus IC sends all of its measurements and displays via the telephone connection tothe response centre, where the displays are duplicated. The medical expert at the ResponseCentre is also able to annotate (with words, symbols and markings) and send back the stillvideo picture to better illustrate the verbal instructions being given to the operator at the remotelocation. If necessary, the expert can take control of most functions of the Tempus IC, givingadded comfort to both the user and patient.
Tempus IC User/Operator ManualPage 20 41-1001-044 Introduction to the Tempus IC4.1 Tempus IC DeviceThe Tempus IC is a multi-parameter vital signs monitor which connects to a dedicatedResponse Centre. Connection is achieved using different communications technologies, referto the Modes Menu on your Tempus for details of what communications systems it can be usedwith.A physician may use the Tempus IC as a stand-alone diagnostic device (without it beingconnected 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 rateThese readings are transmitted via a communications link to a computer at a response centrewhich enables the physician to see all the vital signs data.Additionally, the Tempus IC includes a colour video camera which is capable of sending colourstill images to the response centre.The following sections describe how each of the sensors, the camera and communicationssystems work.The Tempus IC consists of a enclosure which is overmoulded with rubber to make it resistantto shock. The enclosure also includes a rear clip which provides storage for the SpO2sensor,the NIBP cuff and communications cable.The Tempus IC4.1.1 Tempus IC FrontThe 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. Alsopresent is a jog wheel which can be used to scroll through instructions.4.1.2 Tempus IC BaseThe base of the Tempus IC houses the battery.JogWheelDeployableFeetTouchscreenBatteryMembranebuttons
Tempus IC User/Operator ManualPage 21 41-1001-044.1.3 Tempus IC RearThe 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 theheadset 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 foraesthetic purposes. The clip carries a general product label for regulatory purposes and alsotwo labels which help guide the user to repack the SpO2 sensor and the comms cable. Thetop of the clip carries a product-specific brand also.4.1.4 Tempus IC SidesThe left side of the device contains four connectors for:ECG - blue,NIBP – white latching connector;SpO2– orange;ETCO2. – yellow.Normally the NIBP and SpO2connectors will have their mating half attached at all times.Left Side of the TempusThe 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 mouseand keyboards) approved for use with the Tempus IC by RDT. It is also for use withthe USB - Serial Cable (part number 01-1022) for customers using Iridium or otherserial satcoms systems.WARNING: The USB connection must only be connected to non-mains poweredperipherals (such as a mouse or keyboard) or to interface accessories providedby RDT (such as the USB-Serial Cable pn 01-1022). Any connections made tothe USB port must be to medical or IT peripherals or communications systemswhich comply with the applicable IEC safety standard (i.e. IEC60601-1 orIEC60950). Any connection arrangements must be made in a mannercompliant with IEC60601-1-1.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
Tempus IC User/Operator ManualPage 22 41-1001-04The RJ-45 connector provides the Ethernet connection (the Ethernet cable is normally fitted).Communications Connection Panel
Tempus IC User/Operator ManualPage 23 41-1001-045 Using the Tempus ICNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.5.1 Controlling the Tempus ICThe Tempus IC is graphically rich and provides audio feedback from the device in the form ofbeeps, tones and error messages. The feedback differs depending on if the user pressesactive 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 twobuttons 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 ICThe Tempus IC provides the user with complete instructions on how to use it. Every step isdetailed in pictures with accompanying text instructions. There are instruction processes foreverything 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 threedistinct 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 orpictures are being transmitted and what the time is when recorded.2. Process Instructions This area contains the graphical pictures and text instructions thatshow you how to use the device. This takes the user through eachactivity one or two steps at a time.3. Touch Screen Buttons In this example there are two buttons at the bottom of thetouchscreen. In all cases the user will press the button on the bottomright of the screen to progress onto the next step in the process.
Tempus IC User/Operator ManualPage 24 41-1001-04Example of the Tempus IC Screen Layout5.1.1.2 Progressing through Help ProcessesAs mentioned above, the Tempus IC breaks all processes down into small steps. These stepsare 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 Ribbonnear the top of the screen.Example of the Process RibbonIn the example shown above, the screen shows that the process has 6 steps and that thedevice is showing steps 1-2.The user follows the instructions given on the screen, ensuring that they review both the imageand the text. Once they have completed both steps they proceed onto the next steps bypressing the Next touchscreen button.Pressing this will bring up the instructions for the next 1 or 2 steps in the process. Similarlythey can go back to earlier steps by pressing the Previous touchscreen button.Status barHelp processgraphics andinstructionTouch screenbuttonsProcessRibbon
Tempus IC User/Operator ManualPage 25 41-1001-04Example of the Middle Steps of a ProcessAt the end of a process, the Next touchscreen button changes to show an icon that relates to starting theaction 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 Process5.1.1.3 Getting HelpAs 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 differentaspects of using the Tempus IC. For example, when the first Help Menu is on the screen, thenext menu (Cleaning and Repacking Menu) can be accessed by pressing the Nexttouchscreen button.Iconshows endof processProcessRibboncompleteProcessRibbonupdatedNext button toprogress tonext stepPreviousbutton toreturn tolast step
Tempus IC User/Operator ManualPage 26 41-1001-04Example of the Help MenuExample of the Cleaning and Repacking MenuThe user can move backwards and forwards through the Menus by pressing the Next andPrevious touchscreen buttons.From the HelpMenu, pressthe Nextbutton to bringup theCleaning andRepackingMenu
Tempus IC User/Operator ManualPage 27 41-1001-045.2 Explanation of the Tempus IC ScreenTempus IC screen normally divides into two sections:Connection status and time of day at the topInstrument readings in the middleExample of the Tempus IC Screen Display5.2.1 Status Bar – Clock (Time Stamp)The time of day is shown in Greenwich Mean Time (GMT), which is also known as UniversalTime Co-ordinate (UTC). Tempus IC has an internal clock which is automatically synchronisedto an accurate time reference at the Response Centre as soon as a call is made.Example of the Tempus IC Screen Display5.2.2 Status Bar – Bluetooth®IndicatorThe Bluetooth® indicator identifies the number of Bluetooth®peripherals that are connected tothe device, i.e. 1 sensor at this time.NOTE: It does not identify the specific peripheral connected to the Tempus IC.Bluetooth® Peripheral IndicatorStatusbarInstrumentReadingsBluetoothIndicatorTimeinGMT
Tempus IC User/Operator ManualPage 28 41-1001-045.2.3 Status Bar - WiFi IndicatorWiFi Status IndicatorThis indicator is displayed when the Tempus IC is connected to the Response Centre usingWiFi communications technology.5.2.4 Status Bar – GSM/GPRS IndicatorGSM Status IndicatorThis indicator is displayed when the Tempus IC is connected to the Response Centre usingGSM 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 strengthis not sufficient to support a data connectionTwo orange bars means that a data connection can be made but that the performancemay be impaired.Three to five green bars means that the signal strength is sufficient for a dataconnection.NOTE: The Tempus IC uses GSM and GPRS networks to make a data connection. Thisrequires the network signal strength to be better than is required for a conventional GSMhandset (which makes a voice only connection). Users should note that the signal strengthreadouts 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 ReadingsThis 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 ofinformation i.e. data taken, time taken and type of units are displayed. Descriptions of theinstrument readings are contained in the sections of this manual which describe eachinstrument.When iAssist help processes are displayed, they take up the space normally occupied by theinstrument readings and the status indicators.All of the measurements except blood pressure and ECG are continuous, that is they are takenautomatically without operator intervention. Data from these measurements is sentautomatically to the Response Centre in real-time (if the data line is active), otherwise themeasurements 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 theResponse Centre. ECG measurements can be initiated manually by the operator orremotely by the Response Centre.All data which is generated by the Tempus IC is automatically time-stamped.WiFiIndicatorGSM /GPRSindicator
Tempus IC User/Operator ManualPage 29 41-1001-045.2.6 Instrument Status IndicatorsThe Instrument Status indicators show what each instrument is doing. The status can be oneof the following:Measuring The instrument is currently taking a readingIdle The instrument is currently idleOn timer The instrument is making timed measurements (e.g. blood pressure) andwill make another measurement in due course.Disabled The instrument is disabled, possibly due to a fault (see Troubleshooting insection 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 theinstrument readings and the status indicators.5.3 Device SensorsAll 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 ResponseCentre: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 ofthe connection. Higher bandwidth connections (e.g. using Inmarsat Swift 64, Fleet 77, B-GANor 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 containsa visible (red) and invisible (infrared) light source and matching sensors. The sources andsensors are arranged so that the lights shine through the patient's finger when it is inserted intothe 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 obtainablefrom patient’s with nail varnish or polish, consequently the Tempus IC is stocked with nailvarnish removing wipes in the bag. In the event that these are needed, the operator shouldfollow the instructions on the wipe.5.3.2 Blood PressureTempus IC uses non-invasive techniques to measure the patient's blood pressure. A pumpwithin 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, whichcan be detected and measured. As the inflation pressure changes, the systolic, diastolic andmean arterial pressure can be measured.This method of blood pressure measurement provides accurate readings provided that thecorrect 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 theheart. Tempus IC uses 10 electrodes (in a pre-set reusable apron configuration) placed mainlyon opposite sides of the heart to detect these currents.
Tempus IC User/Operator ManualPage 30 41-1001-04The position of the electrodes is critical and so Tempus IC uses a specially moulded electrodeapron 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 madeof elastic material so that as it stretches to accommodate different sizes of patient, the positionsof the electrodes vary to maintain correct placement.5.3.4 End Tidal CO2(ETCO2) and Respiration RateThe Capnometer CO2module is used to monitor continuous carbon dioxide and report the EndTidal carbon dioxide (ETCO2), inspired CO2and respiratory rate values of non-intubated adultpatients. The Capnometer CO2module is used for the continuous measurement of CO2(carbondioxide) and respiratory rate.The capnometer uses a Sidestream sampling system with a low sampling rate that is used tomeasure the CO2. A tube inserted into the patient's nostrils detects samples of their exhaledbreath. The tube is connected to a pump within the module which draws the sample through ameasuring chamber.In the capnometer, infrared light is generated by the sensor and beamed through the samplecell to a detector on the opposite side. CO2from the patient that is aspirated into the samplecell absorbs some of this infrared energy. The monitor determines CO2concentration in thebreathing gases by measuring the amount of light absorbed by these gases. ETCO2isdisplayed as a partial pressure in millimetres of mercury (mmHg). Respiration rate is calculatedby measuring the time interval between detected breaths.5.4 Digital CameraA miniature digital camera is mounted in the unit. Images from this camera can be sent to theResponse 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 withgreater bandwidth will transmit the picture in less time.5.5 Voice and Data CommunicationsThe Tempus IC can connect over either modem connections, over serial channels and overwired or wireless (WiFi) Ethernet networks. The Tempus IC will be pre-configured by RDT tooperate over the user’s network.NOTE: RDT recommends that users perform a test connection to the response centreevery month in order to verify that their communications remain open for theTempus to use.
Tempus IC User/Operator ManualPage 31 41-1001-046 Setting UpNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.6.1.1 Unpacking the Tempus ICThe Tempus IC is supplied from the factory in protective outer packaging. No specialprecautions are required when unpacking the Tempus IC. You do not need to keep thepackaging. RDT recommends that the equipment is inspected and tested on receipt to confirmthat the unit has not been damaged and that all expected items and accessories have beenreceived and are in working order. New batteries should be charged up for at least 4 hours onreceipt.6.2 Tempus IC BagThe Tempus IC bag is a custom design part made from moulded rubber. It is provided with ashoulder strap and carry handle.The bag provides a main storage area for the Tempus IC (including windows to check thebattery status and turn the device on externally to avoid the user opening the bag to do this), astorage area for the ECG harness, a range of pockets for consumables in the lid and a range ofpockets for accessories and consumables on the rear.Each bag contains the following items:1Tempus IC fully packed including battery, Adult BP cuff and hose, SpO2 probe andEthernet cable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 Bluetrek®Thermometer*1 Bluetrek®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1 Ethernet Cable to Modem Adaptor ***1 USB - Serial Cable***
Tempus IC User/Operator ManualPage 32 41-1001-04* Note: that Tempus IC will initially be shipped with Glucometer and Thermometers that are ready for use but disabledin software. They will be enabled for use by a future software upgrade. The thermometer and glucometer will not beoperable until the software upgrade has been performed.** Note: non-commercial aviation users who do not use Iridium satcoms systems are provided with a single extensionreel.*** Note: not supplied to commercial aviation customersRefer to section 11.1 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 packagedin 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 BagWindow to accessthe ON/OFFbuttonWindow to accessthe Battery chargeindicator
Tempus IC User/Operator ManualPage 33 41-1001-04The Bag open with the Tempus IC removed6.3 Switching On6.3.1 Immediately after Switching OnNoteThe Tempus IC takes up to one minute to become ready for operation after switching on. It isrecommended that you switch on Tempus IC at the same time as you remove it from itsstorage 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. Thedevice is ready for use when the LED shines green constantly. If no buttons are pressed within 8minutes, 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 artworkis 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 OximeterConsumables in colour-coded pocketsTempus IClocationECG HarnessAccessories andConsumables in colour-coded pockets
Tempus IC User/Operator ManualPage 34 41-1001-04You can press to jump straight to the results screen, or any other button to get help forthat instrument e.g. pressing will bring up the first Help Menu or pressing will bring upthe help menu for the capnometer.
Tempus IC User/Operator ManualPage 35 41-1001-047 Establishing Communication with theResponse CentreThe 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 withoutconnecting to the Response Centre. Under these circumstances, just press the appropriatemeasurement function button to access that function. It is still possible to be connected to theResponse 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 linkdisconnected i.e. if the Response Centre physician wishes to continue monitoring the patientfor a long duration but without keeping the voicelink open with Tempus IC User. In this casethe voicelink can be reconnected at any time by pressing the Connect button.7.1 Making the Phone ConnectionPress the button on the touch screen to get instructions on how to setup and connect the dataconnection. 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 Headsetscreen will appear.Dialling the Data ConnectionIf the Response Centre cannot be contacted, this could be due to errors in the way that theconnection has been attempted (see section 10.3 of this manual for Troubleshootinginformation). Help will be given in the form of iAssist help process, follow the instructions givenand wait for a few minutes before trying again.
Tempus IC User/Operator ManualPage 36 41-1001-04If your Tempus has been configured for automatic redialling, then it will attempt to connect tothe Response Centre if the first call fails. The system will indicate the redial process bydisplaying a number over the Data Link status indicator. The system will attempt a number ofredials (typically 3), and will display the corresponding number over the Data Link statusindicator bar.7.2 Fitting the Headset and Making the VoiceConnectionAfter dialling the data link the device will by default bring up instructions to fit the wirelessheadset. Follow the onscreen instructions and at the end of the process press the buttonon screen to dial the voice link.It is important to have attached the headset before dialling as the voice connection to theresponse centre can be made quickly.Remember that often the voice connection will be made over a satellite link so you mayexperience background noise or drop-outs. RDT recommends that you adopt a process of onlyone person speaking on the line at a time and then handing over to the other speaker by saying“over” or similar.Example of the Wireless Headset IAssist help processNOTE: If you do not wish to use the wireless headset, a wired headset is provided inthe bag as an alternative. To switch to the wired headset press the buttonon the touch screen as identified in the above screen and follow the on-screeninstructions showing you how to use it.
Tempus IC User/Operator ManualPage 37 41-1001-04Example of the Wired Headset IAssist help processNOTE: To switch to the Wireless Headset press the button on the touch screenas identified in the above screen.7.2.1 Using the Wireless HeadsetThe Tempus IC uses the G3 headset provided by Bluetrek®. Note that the headset will besupplied in a charged state and its charge level is automatically maintained so long as it isregularly 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” withthe Tempus IC. You cannot use different wireless headsets with the Tempus IC and RDTrecommends that you do not attempt to use the G3 supplied with the Tempus IC with any otherwireless devices (including other Tempus ICs or other communications devices such as mobilephones).Each G3 is “paired” to only the Tempus IC to which it is attached on delivery. While attachingthe G3 to other Tempus IC units will not cause any damage, users should avoid this practise asit 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.7.2.1.1 IntroductionThe headset has 3 buttons:TALKVOL +VOL –
Tempus IC User/Operator ManualPage 38 41-1001-047.2.1.1.1 Wearing the HeadsetTo put the headset on, follow the instructions given on screen. Note that the ear clamp is madefrom soft material. It can be flexed and shaped to fit your ear. You should ensure the speakeris properly inserted into your ear.7.2.1.1.2 Controlling the Wireless HeadsetTo turn the headset on, remove it from its dock and press and hold the talk button for 2-3seconds 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 theheadset into pairing mode. This is not desirable as it could potentially causethe headset to cease being paired with the Tempus IC and thus prevent it fromoperating with the device. Airing mode can be recognised by the indicator lightslowly flashing red and then blue. If the headset is inadvertently put intopairing mode it should be placed back onto the docking pin on the Tempus toturn 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 lightflashes 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 ontothe Tempus IC. If you do wish to turn the headset off, press and hold the talk button for 5seconds 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 callagain with the headset i.e. if you turn the headset back on you will not hear thecall again. If the headset is turned off during a call, disconnect the call usingthe 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.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. Torelease muting, quickly press the “vol+” button on the headset. RDT does notrecommend that you use the muting function as this could cause confusionduring a call.If you need to adjust the volume of the headset of the wireless headset (the wired headset hasno volume controls) after you have connected the voicelink, you can get instructions on how toadjust the volume by pressing the button. This is shown the first time yougo into the camera iAssist process and the first time you go into the blood pressure and pulseoximetry process after switching on. You can also access the same instructions by pressingthe Headset button on the main help menu after you have connected the voicelink.
Tempus IC User/Operator ManualPage 39 41-1001-04Headset Help ButtonPressing the Headset Help button will bring up an iAssist process. This contains four differentsteps, each of which gives instructions on addressing a different type of issue e.g. you can’thear the response centre, they can’t hear you etc.iAssist Process for Adjusting the Wireless Headset’s Volume7.2.1.1.3 ChargingRDT 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 willinstruct you to clean the headset after use and to replace it on its docking pin before shuttingdown.If you do not replace the headset then the Tempus will show an error advising that the headsetshould be refitted.Placing the headset onto the docking pin enables the Tempus IC to recharge it. The TempusIC recharges the headset for up to 4 hours 30 minutes (apx) every time the headset isreplaced. 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 onthe headset will light red for the duration of the charging process although it may switch offintermittently for 8 second periods (this is part of the charging process). The indicator light willgo off when charging is complete – which could be less than the 4 hour 30 minute maximumcycle time depending on how depleted the headset battery is.
Tempus IC User/Operator ManualPage 40 41-1001-04In 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 (apx).The Tempus IC will not recharge the headset battery if the main battery is nearly empty (lessthan 5% charge).Caution: Do not attempt to charge the headset using any other charging device. Thiswill automatically suspend the warranty and could be dangerous.Note: The headset has a life of up to 500 charge cycles.7.2.1.1.4 General Guidelines for Safe Use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 hasno protection against ingress of solids or liquids.Do not expose your headset to extreme temperatures. The temperature range of theheadset is 0-40C.Do not try to disassembly your headset. Service and Maintenance can only beperformed by RDT.Do not let children play with the headset since it contains small parts that couldbecome detached and create a choking hazard.CAUTION: Danger of explosion if battery is incorrectly replaced. Do not attempt to repairor replace the battery. If the battery is worn out a new headset is required fromRDT. Dispose of the headset in accordance with local regulations. Do notdispose as household waste.The user manual for the Bluetrek®G3 headset is supplied on the same CD-ROM as thismanual. Details from that manual have been reproduced in this section courtesy of Bluetrek®.7.3 Connection Status IndicatorsNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.The connection status indicators show whether the Tempus IC is connected to the ResponseCentre. 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.
Tempus IC User/Operator ManualPage 41 41-1001-047.3.1 Dialling Order and Indicators When DiallingOnce 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 flashindependently until each link has been connected.While waiting for the voice link to connect, the Tempus IC can be used to take measurementsof the patient e.g. blood pressure, pulse oximetry and a video picture, which will then beavailable to the response centre as soon as the connections have been completed.7.3.1.1 Data DiallingOnce dialling has been initiated, text will appear giving a countdown to when the data link isexpected to connect. This is accompanied by a blue progress bar which grows as the time toconnection gets closer.Once the data link has been established the text indicator will display “Data Connected” andthe “Call in progress” indicator which will stop flashing.7.3.1.2 Voice DiallingThe voice link will start to dial as soon as the data link is connected. If the data link is takinglonger to connect than usual (as a result of difficulties with the communications channel) thenthe 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 itcan be before the voice line will start to dial, the voice link will typically dial before thecountdown is completed.Once the voice link has been established the text indicator will display “Data Connected” andthe “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 itwill need to log onto the network at the beginning of each call. This is shownby similar text and a separate progress bar for logging on.7.3.1.3 Automatic RediallingIf the Tempus IC is configured to redial the voice or data links automatically then it will indicatethat a redial is taking place by displaying a number behind the “Call in progress” indicator.7.3.1.4 Indicators Once Connections Have Been EstablishedOnce the voice and data links have been connected, their status indicators will stop flashing. Inaddition, once the data link has been established the progress bar will disappear and thefollowing text will be displayed.7.3.1.5 File Transfer Status IndicatorWhen data files (either an ECG or a still digital picture) are being transmitted, the progress barshows how far the transmission has progressed.
Tempus IC User/Operator ManualPage 42 41-1001-047.4 Communications ModesTempus IC can connect to the Response Centre using different connection a number of wiredand wireless communications interfaces e.g. Ethernet or WiFi.Connecting over wired interfaces such as Ethernet requires connecting the Tempus using acable; connecting over wireless interfaces such as WiFi require no physical connection to bemade.To switch between these types of connection, the Tempus IC is pre-set to connect usingdifferent communication “Modes”. Each Mode is supported by a full set of graphical connectioniAssist help process that provide the User with instructions specific to connecting using thattechnology.The Tempus IC shows what Mode it is in with a banner at the top of the Connection IAssisthelp process.The Tempus IC will stay in this Mode until it has been set to another Mode (even if it has beenturned off and on again).7.4.1 Changing ModesYou can change the Mode that the Tempus IC is set to by pressing from the Help MenuIAssist 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 ModesThe Modes that are available on each Tempus IC are dependent on the requirements of eachUser. Refer to the Modes Menu on your Tempus IC for specific details of each Mode that isavailable.Remember that each Mode may have a different set of instructions for connecting, fault findingand repacking. Consequently it is vital that you remember to read and follow what each iAssisthelp process says at all times.It is also important to remember that if one Mode cannot be used then another may be usablein its place e.g. if GSM coverage is not available then a landline connection may be useableinstead.7.4.3 Changing the Connection ModeTo change mode, bring up the help menu and then follow the instructions below:
Tempus IC User/Operator ManualPage 43 41-1001-04The Modes Menu Button on the Help MenuExample of the Modes MenuIf you wish toexit the ModesMenu presshere.2. Then makethe relevantselection bypressing on oneof the buttonsshown here –CHECK the titleof the mode iswhat you want.1. Press thetouchscreenhere
Tempus IC User/Operator ManualPage 44 41-1001-04Example of the New Mode Title3. You canconfirm that thecorrect selectionhas been madeby checking thetitle.
Tempus IC User/Operator ManualPage 45 41-1001-048 Taking Medical ReadingsNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.The Tempus IC is intended for use on one patient per incident. It must not be used on morethan one patient because the Tempus IC has no way of associating a measurement with aparticular patient.WARNINGIt is essential to switch off the Tempus IC in between different patients to avoidconfusion between different patient records.8.1 Blood Pressure and Pulse OximeterTo activate the Blood Pressure & Pulse Oximeter function, press the button on the device. Thefirst step in the Blood Pressure & Pulse Oximeter help process will appear.Follow the instructions provided on the iAssist help process to activate Blood Pressure & PulseOximeter.Select the correct size blood pressure cuff from the storage compartment (the normal size adult cuffis 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, insertusing a twisting motionExample of the Blood Pressure And Pulse Oximeter Help Screen
Tempus IC User/Operator ManualPage 46 41-1001-04WARNINGSThe 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 orvisible alarms.Reposition the oximeter probe at least once every 1hour to allow the patient's skin torespire.The SpO2 sensor should snugly fit the finger without straining it and if not alternativefingers should be tried.The Tempus IC will not operate effectively on patients who are experiencing convulsionsor tremors.Prolonged or repetitive use of the blood pressure cuff may harm skin integrity andcirculatory status. Observe the limb concerned to check that circulation is not impaired.CAUTIONOneTime®nail polish remover is flammable. Keep away from heat and flame. Useadequate ventilation. Exposed pad should be placed on glass or tile surface only. FOREXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN.NotesDyes introduced into the bloodstream, including methylene blue, indocyanine green, indigocarmine and fluorescein may cause an inability to determine accurate SpO2readings.Any condition that restricts blood flow, such as use of a blood pressure cuff (other than theTempus IC cuff used in accordance with the instructions herein) may cause an inability todetermine accurate pulse and SpO2readings.Compression or restriction of the blood pressure hose or cuff, or induced movement or vibrationmay prevent the monitor from taking a reading.SpO2measurements may be adversely affected in the presence of high ambient light levels. Ifnecessary, shield the sensor area (e.g. with a towel).Remove fingernail polish or false fingernails using the wipe provided before applying SpO2sensors. Fingernail polish or false fingernails may cause inaccurate SpO2readings.Performance and safety test data are available on request from the address in section 1.1.Significant levels of dysfunctional haemoglobins, such as carboxyhaemoglobin ormethemoglobin will affect the accuracy of the SpO2measurement.The graphical displays of pulse rate, SpO2and pulse strength are not proportional to the pulsevolume.The SpO2sensor must be on the opposite arm to the blood pressure cuff. The arm of thepatient 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 goodresults, this could be due to poor perfusion of blood. Ensure that the finger is inserted all wayinto the clip, or try taking a reading on another finger.
Tempus IC User/Operator ManualPage 47 41-1001-04IMPORTANTYou 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 ResultsThe Pulse Oximeter display has four data elements. Measurements are made continuouslyand updated in real time. Measurements are sent in real time to the Response Centre providedthat the data link is active.The Pulse section contains a bar graph and digital display of the patient's pulse rate, in beatsper minute (Bpm).Note that extreme pulse rates above 175 Bpm or below 25 Bpm are outside the range ofthe bar graph display but will be shown accurately on the digital display.The SpO2section gives the oxygen saturation of the blood, and displays the result in bar graphand digital form.Note that extreme blood oxygen levels below 50% are outside the range of the bar graphdisplay 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. Theamplitude of the indication indicates the quality of detection. If the indication on the SignalStrength meter is low, or becomes low, then the finger sensor should be repositioned. Similarlythe Perfusion Index gives a numerical indication of the level of arterial pulsatile blood at thesensor site.8.1.2 Understanding the Blood Pressure ResultsThe Blood Pressure display has three elements plus a status indicator. The results compriseSystolic 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 Statusicon. Pressing this button at any time will stop the blood pressure monitor and cause the cuff todeflate immediately.The measurements are normally made every five minutes via an automatic timer. Note thatwhen the unit is in timer mode, the Cuff Status icon will change state. The possible states ofthe 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 ManualPage 48 41-1001-04Cuff is on timer.Measurements are sent to the Response Centre every time they are made, provided that thedata link is active.8.1.3 Blood Pressure Monitor Error iAssist Help ProcessThe Tempus IC will automatically display iAssist help process in the event that it encountersproblems in taking a blood pressure measurement. The problems that it can encounter mayoften have a fairly simple solution, consequently, the iAssist help process attempt to guide theOperator 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 validreading 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 instructionson how to check for and clear the problem. It should be understood that it can be normal toexperience these types of errors when taking readings if the usage instructions have not beenfollowed carefully.8.2 Electrocardiograph (ECG)To activate the ECG function, press button on the deviceThe first step in the ECG help process will appear.Follow the instructions provided on the iAssist help process to activate ECG.WARNINGSThe Tempus IC should not be used on patients undergoing defibrillation. The TempusIC is protected against defibrillator discharge but rate meters and displays may betemporarily affected during defibrillator discharge but will rapidly recover.The Tempus IC will not operate effectively on patients who are experiencing convulsionsor tremors.
Tempus IC User/Operator ManualPage 49 41-1001-04Example of the ECG Help ScreenCAUTIONSThe electrodes of the ECG apron must be applied carefully.Care must be taken to ensure that the electrodes do not contact live (electrical) parts orearthed metal parts of local systems or structures.The ECG spray is not to be used on broken or irritated skinNoteWhilst the ECG harness fits many patients, one size cannot fit all patients. Consequently, theECG 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 ofdamage before and after use.The ECG spray is not a disinfectant. If the ECG contact spray goes into a person’s eyes, it maybe washed out using clean water.The ECG spray bottle is marked with a label reading “USE BY:” and then giving a date. Allbottles of fluid must be discarded once this date has been reached.
Tempus IC User/Operator ManualPage 50 41-1001-04Once the iAssist process has been completed the Tempus will display the ECG.The ECG Monitoring ScreenThe Tempus IC is now monitoring the patient's ECG, but is not recording the information. Thetraces move across the screen from left to right, erasing and replacing old readings as themonitoring progresses. It takes 3-4 seconds for the trace to cross the screen. You should waitat 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 driedoff;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 50Hz1or 60Hz. ECG systems can pick upinterference from mains electricity supplies. This interference appears on the screen as regularinterference patterns. The filter setting is shown in the bottom left corner of the ECG. It willeither show 50Hz or 60Hz as lit, pressing on this area of the touchscreen will change thesetting.8.2.1 Monitoring an ECGTo 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 nottalk or move while an ECG is recorded. If the patient is moving then the muscle movement canproduce 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 notby the heart) may not be clear enough for a medical professional to make a diagnosis so it isimportant that the patient remains completely still during the recording.1Hz means Hertz, or cycles per second. In North America, mains electricity supplies operateat 60Hz; most of the rest of the world uses 50Hz. In aircraft the filter should normally be set to50Hz. In remote land and maritime applications the local voltage could be either 50Hz or 60Hz.
Tempus IC User/Operator ManualPage 51 41-1001-04Wait for the ECG trace to stabilise (like the trace shown above), ask the patient to breath in andout and then to hold their breath for 10 seconds before pressing ‘record’ If the trace does notstabilise, 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 indoubt).If you are not satisfied with the EGC trace e.g. it is unstable on some or all of the traces, youcan press the ECG Assistant button on the touchscreen. This will ask you to confirm which partof the ECG you are dissatisfied with and will then offer more detailed instructions on theapplication of the ECG harness based on which traces you have indicated are suspect.8.2.2 Recording an ECGOnce the recording is complete, the results will be displayed as shown in the following picture.ECG RecordedIf the Tempus IC is connected to a Response Centre, it will automatically start to transfer theECG file.At this point you can press to close the ECG view to return to the main screen or you canpress ‘monitor’ on the touch screen to return to monitoring mode. Note that if you turn the ECGoff at this point and then restart the ECG function later during the same incident (withoutswitching the Tempus IC off), these results will be shown again. This means that you can viewthe last ECG that was recorded from the patient.CAUTIONIt is essential that the Tempus IC is switched off before it is connected to anotherpatient, otherwise information from one patient (e.g. an ECG recording) may beconfused with that taken from another patient..
Tempus IC User/Operator ManualPage 52 41-1001-048.3 CapnometerTo activate the Capnometer function, press button on the deviceThe 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 ScreenWARNINGSThe Tempus IC is not intended for long term patient monitoring. There are no audible orvisible alarms.The Tempus IC is not for apnoea detection. The Tempus IC has not been tested orvalidated for use in apnoea detection.CAUTIONUse of monitoring during continuous nebulised medication delivery will result indamage to the Tempus IC which is not covered by the warranty. Disconnect thecapnometer sample line from the Tempus IC or switch off the Tempus IC duringmedication delivery.
Tempus IC User/Operator ManualPage 53 41-1001-04NotesThe capnometer is not for use in conjunction with breathing or anaesthetic systems.8.3.1 Understanding the Capnometer ResultsThe Capnometer display has two elements. Measurements are made continuously (for 15minutes after the capnometer has been activated) and are updated in real time. Measurementsare 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 ETCO2results.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 breathingrate, in respirations per minute (Rpm).Note that extreme rates above 50Rpm are outside the range of the bar graph display butwill be shown accurately on the digital display.The ETCO2section gives the partial pressure of the exhaled CO2at the end of the breath. Thisis displayed in bar graph and digital form..
Tempus IC User/Operator ManualPage 54 41-1001-048.4 Thermometer2To activate the thermometer, press button on the deviceThe 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 viaBluetooth®.Example of the Temperature Help ScreenCAUTIONThe thermometer provides fast, accurate temperature measurements on any patient intowhich its probe can be inserted into the ear canal to view the tympanic membrane. Itcan be considered for use on any patient above three (3) years of age. Do not use thethermometer if the probe cannot be inserted into the ear canal.The thermometer should always be used with a probe cover attached. Probe coversshould be replaced between each measurement.2Note that the thermometer functionality is currently not enabled for US customers pendingregulatory clearance.
Tempus IC User/Operator ManualPage 55 41-1001-04NotesAllow the thermometer and the patient to acclimatise to the same ambient temperature beforetaking temperature readings.Dirt, greasy films or moisture on the thermometer lens may affect the accuracy of theinstrument.Deposits of cerumen (ear wax) can affect the measurement.Do not open the thermometer case. The thermometer will require factory recalibration if thecase 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 theprobe. 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 thedevice will not operate.The thermometer’s sensor requires a few seconds to stabilise at the measurement site before areading can be taken. If the measurement button is pressed too quickly after the thermometeris 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 thethermometer back into the patient’s ear (as per instructions), wait 6 seconds and then take thereading.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 theprobe. This could make the body temperature measurement lower than usual.The thermometer is switched on and off using the “ON/MEM” button. Press the button brieflyonce (when instructed by the on-screen instructions) to turn the thermometer on. It willautomatically try to communicate with the Tempus IC over the Bluetooth® link. Press and holdthe ON/MEM button for 3 seconds to turn it off. Note that to extend the battery life thethermometer 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 beshown on the thermometer’s display (but not transmitted to the Tempus IC) if the ON/MEMbutton is pressed after the device has been turned on e.g. if the button is pressed once it willshow the most recent reading (preceded by a “1”), if pressed twice it will show the readingtaken before that (preceded by a “2”) and so on. For this reason it is recommended that theON/MEM button is not pressed and also that the thermometer display is not reviewed whileobtaining temperature readings.The thermometer is normally supplied set to read in Centigrade (ºC). If required, it can bechanged over to read in Fahrenheit (ºF). See section 12 for information on how to change thethermometer reading. If the user wishes to switch the units that the thermometer itself displays,this can be achieved by pressing and holding the measurement button at the when turning thethermometer on.Note that holding the thermometer too long may cause a higher ambient temperature readingof the probe. This could make the body temperature measurement lower than usual.Only use non-rechargeable batteries with the thermometer.Do not attempt to use, swap or pair the thermometer with other Tempus IC units or otherdevices. Consult RDT if you need replacement thermometers.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 received100% of the time. Risk factors for example would include the user moving out of range duringthe measurement or environmental factors e.g. building materials and construction designreducing operational effectiveness. Users should note that if a reading is not received theyshould repeat the process, if possible this should be done closer to the Tempus IC.
Tempus IC User/Operator ManualPage 56 41-1001-04Users should note that while the Bluetooth technology will operate in environments where otherBluetooth devices are in use, operation can be affected if the number of other devices becomesvery high (e.g. there can be high densities of devices at trade shows). If issues with aBluetooth connection are experienced then the measurement should be attempted again eitherin a different environment (with less Bluetooth devices turned on locally) or closer to theproduct.Note that the thermometer is only provided to customers outside of North America. Thisfunctionality will be provided to customers based in North America once the relevant regulatoryapprovals have been granted.8.4.1 Using the ThermometerWhen following the on-screen instructions, attention should be paid to the signals given out bythe thermometer. If measurements are taken incorrectly (too quickly, at the wrongmeasurement site etc.) then the thermometer’s display will show an error. Errors are discussedin section 10.3.It should be noted that once the thermometer is turned on it will power itself off after 1 minute ifno buttons are pressed, therefore the onscreen instructions should be followed promptly afterthe thermometer has been turned on.It is recommended that 3 measurements are taken from the same ear and the highest of thethree used.8.4.2 Understanding the Thermometer ResultsWhen measurements are made, they are time stamped and sent to the Response Centreprovided 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 ManualPage 57 41-1001-048.5 Glucometer3To activate the Glucometer function, press button on the deviceThe first Glucometer help screen will appear.Follow the instructions provided on the iAssist help process to activate Glucometer.Example of the Glucometer Help ScreenWARNINGThe GlucoTel 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 NorthAmerica and in mmol/l format in all other areas.CAUTIONSDo not store the glucometer strips outside of the stated environmental limits. Ensurethat shelf life information is heeded.Ensure that the instructions for use attached to the strips are heeded.3Note that the glucometer functionality is currently not enabled for US customers pendingregulatory clearance.
Tempus IC User/Operator ManualPage 58 41-1001-04Glucometer NotesThe glucometer used with the Tempus IC is the GlucoTel®meter made by BodyTel®ofGermany. The Tempus IC uses the GlucoTel®meter as it is intended i.e. to measure apatient’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 theresponse centre that receives the Tempus IC call rather than the BodyTel®Centre.The GlucoTel®meter measures the patient’s blood glucose levels and transmits themwirelessly (over Bluetooth®) to the Tempus IC.The GlucoTel®meter has been labelled with a Tempus IC badge on the top in order that it canbe visually associated with the Tempus in case the two products are separated. However themeter remains a product of BodyTel®and retains their labelling and contact details on thelabelling on the underside.The user manual for the GlucoTel®meter is provided on the same CD-ROM as this manual.While applicable extracts of the GlucoTel®manual are reproduced in this manual, Users shouldalso read the manual of the GlucoTel®meter to ensure they have familiarised themselves withthe device.Do not insert objects (e.g. pins, paper clips etc.) through the hole on the RDT label on the topface of the glucometer. This can cause the glucometer to lose its pairing with the Tempus(which will stop it from working). Pairing is described in the Maintenance Manual.Do not attempt to use, swap or pair the glucometer with other Tempus IC units or otherdevices. 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 received100% of the time. Risk factors for example would include the user moving out of range duringthe measurement or environmental factors e.g. building materials and construction designreducing operational effectiveness. Users should note that if a reading is not received theyshould 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 otherBluetooth devices are in use, operation can be affected if the number of other devices becomesvery high (e.g. there can be high densities of devices at trade shows). If issues with aBluetooth connection are experienced then the measurement should be attempted again eitherin a different environment (with less Bluetooth devices turned on locally) or closer to theproduct.If the Tempus displays a reading of HIGH or LOW from the glucometer then this corresponds toa value of >525mg/dl or <20mg/dl respectively.Note that the glucometer is only provided to customers outside of North America. Thisfunctionality will be provided to customers based in North America once the relevant regulatoryapprovals have been granted.Lancet NotesFor use with the glucometer, RDT supplies the “SAFE Press” sterile safety lancetsmanufactured 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 theglucometer as these include the relevant information on the use of the lancets.Users should not use lancets if the protective cap has been removed.
Tempus IC User/Operator ManualPage 59 41-1001-048.5.1 Testing the GlucometerThe GlucoTel®meter can be tested by pressing the button, following the onscreeninstructions and then applying the control solution (either HIGH or LOW) as described insection 4.7 of the GlucoTel®manual.8.5.2 Understanding the Glucometer ResultsWhen measurements are made, they are time stamped and sent to the Response Centreprovided that the data link is active.
Tempus IC User/Operator ManualPage 60 41-1001-048.6 Digital CameraWhen requested by the Response Centre, it is possible to capture and send still digital picturesusing the camera built into the device. Digital pictures are shown live on the Tempus IC screenso 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 connectedthe image will be stored for transmission later).To activate the Camera, press button on the deviceThe first Camera help screen will appear.A digital picture from the camera will appear on the Tempus IC display in the position shown in thefollowing picture.Follow the instructions provided on the iAssist help process to take a photo.Example of the Tempus IC Display Showing Location of Digital pictureNOTE: The Tempus IC will go into the camera process as soon as the voiceconnection has started dialling.
Tempus IC User/Operator ManualPage 61 41-1001-04Example of the Tempus IC Display Showing Photo ImageAim 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 touchscreen to freeze the image.A countdown will appear on the screen before the picture is sent. To discard the image during thecountdown and take another picture, press , otherwise the picture will be sent when thecountdown reaches zero.
Tempus IC User/Operator ManualPage 62 41-1001-04If you are connected over either an Ethernet or WiFi link, it will be possible to send moving video tothe Response Centre.This can be done in two ways:Press the “Transmit Video” button. The “Camera and Video Options” dialog will stay on thescreen and the Response Centre will see what you see in the viewfinder window on the lefthand side of the dialog.Example of the Tempus IC Transmitting VideoPress the “Transmit Video in Background” button. The “Camera and Video Options” dialogwill disappear from the screen; you will be able to see that video is being transmittedbecause a video icon will appear at the top of the screen. This feature is intended to allowusers to transmit video while using other features of the device. Users should note thatwhen the Tempus IC has its foot deployed, the angle of the camera should enable them toframe a patient without the need to hold the Tempus in position.Video IconNOTE: Moving video is intended to give the Response Centre the ability to see thepatient moving or to see around the patient’s environment. Users shouldremember that the resolution and quality of the received video stream will notbe the same as they see on the screen of the Tempus IC due to the effects ofthe video being compressed during transmission. This effect is lessened whenthe image being filmed is more stable or has less activity in it. Therefore inorder to ensure the received video is good quality, Users should try to move thecamera slowly. If rapid movement of the camera is necessary then thereceived image is likely to be have a temporarily lower level of resolution (willappear “blocky”) while the camera is being moved around, this effect willreduce once the camera movement is reduced.
Tempus IC User/Operator ManualPage 63 41-1001-04NOTE: The overall image quality and resolution of the camera is greater for stillpictures than moving video. If the Response Centre require an image with areasonable level of detail (such as a close-up image) then a still photo wouldprobably be more suitable.8.6.1 Annotation of Digital picturesImages 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 remotediagnostic procedure i.e. the physician can send pictures back that can be used to confirm exactlythe issue being examined or discussed, thus avoiding the danger of misunderstanding verbaldescriptions.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 graphics8.7 Interacting with the Response Centre8.7.1 The Response CentreAlthough the Tempus IC may be used without connection to a Response Centre (i.e. if there isa physician locally or if the unit is being used to collect data for later transmission), in mostincidents it is likely that a Response Centre will be contacted as the first priority after havingactivated the device. Each Tempus IC device is pre-configured to dial automatically to aspecific Response Centre. The centre should be staffed 24 hours a day, 365 days a year andbe always able waiting to receive your connection. If a connection cannot be established, youshould 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 topartial remote control by the Response Centre if necessary) and also to transmit the medicaldata to the Response Centre. It is the function of the Response Centre staff to help control thesituation, make an assessment based on the data received and to offer advice on theappropriate steps to take.When interacting with the Response Centre staff, please carry out all of their instructions to thebest of your ability. If anything is not obvious, do not hesitate to ask for clarification or furtherguidance. Most incidents will begin with the Response Centre staff asking questions relating tothe 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 beenmonitored using the Tempus IC before)Nature of the incident e.g. where the incident is taking place, who is responsible for theremote locationWhen interacting with the Response centre staff, you should also realise that they will almostalways 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 (theResponse Centre hardware) are pre-set to operate on GMT (Greenwich Mean Time).
Tempus IC User/Operator ManualPage 64 41-1001-048.7.2 Remote Viewing and ControlThe Response Centre operators will have exactly the same information on their screens asthose displayed on the Tempus IC. Should the Tempus IC display change e.g. if a new helpscreen is brought up, new data is displayed or an error message appears, the ResponseCentre system will display exactly the same information a few seconds later. The onlyexceptions to this are when you are taking a digital picture or when you are monitoring orrecording an ECG, in these situations the Response Centre only see that you are in theprocess of recording the ECG or taking the photo but they don’t see the ECG or photo until itshas been downloaded.Since the Response Centre can see what you see on the device, and since they can control itremotely, if you are experiencing problems using the Tempus IC, they can guide and supportyou in its use.If the Response Centre need to operate the Tempus IC remotely, they should make you awarethat they are activating a function of the device before they do so. Ideally the Response Centrewill 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-lineNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.Although the Tempus IC is generally intended to be used whilst connected from the remotelocation to a Response Centre, the Tempus IC can also be used without the telecomsconnection having been made. All the functions of the Tempus IC operate normally if thetelecoms connections are not made and data can be taken from a patient using all of themedical devices that the Tempus IC provides.Naturally, if a connection has not been established, no data or photographs can be transmittedand there will be no voice connection to the Response Centre operator. However, if theTempus IC is used on a patient without a connection being made, the data is stored andautomatically transmitted once the device is connected. If the device is turned off before it isconnected the data will not be saved.
Tempus IC User/Operator ManualPage 65 41-1001-048.9 GPS LocationThe Tempus IC has a built-in GPS receiver. You can access this feature from the Help menu.The GPS ButtonHaving pressed the GPS button, you will be shown a graphic instructing you to use the featurewhen outside with a clear view of the sky.GPS Help InstructionNOTE: The GPS operation will be limited if the Tempus IC is not used outside with aclear view of the sky.NOTE: The GPS is intended to provide the User and Response Centre with thepatient’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 modesand enabled in all other modes. To turn the GPS receiver on or off, refer tosection 12.
Tempus IC User/Operator ManualPage 66 41-1001-04GPS Fix ObtainedThe GPS may take up to 2 minutes to display a fix. If it unable to obtain a fix (if the view of the skyis 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 lessaccurate. 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 OffBefore switching the Tempus IC off, you should make sure that it is not in use. Make sure thatthe voice and data links are not in use and that the device is not being used to monitor a patientoff-line.Press and hold the On/Off switch for 3 seconds. The system will then bring up the dialogshown 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 tenseconds. 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 resultsscreen.Option B:Press to stop the countdown and bring up the Cleaning & Repacking Menu iAssisthelp process.Option C:Let the unit shutdown.
Tempus IC User/Operator ManualPage 67 41-1001-04Example of the Shutdown Screen8.10.1 Logging Maintenance RequirementsIf consumable items such as the repack kit or a cannula have been used, the Tempus IC willalert you to the need to report the need for these items to be replaced. This alert will beprovided after the shut down has been initiated.In addition to flagging the need for certain consumable items to be replaced, the alert will alsoinform 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 yourmaintenance staff to provide indicated items.NOTE: This feature DOES NOT indicate that the Tempus has developed a fault. This feature is tohelp remind users to report that basic consumable items or maintenance activities arerequired. Users should not report the information displayed by this feature as a fault to RDT.Example of the Shutdown Screen
Tempus IC User/Operator ManualPage 68 41-1001-04In 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 ismaintained in good working order.The potential conditions that can be logged are:Text ConditionBattery charge below 70% The battery charge is below 70% of its potential fullcapacityBattery charge below 50% The battery charge is below 50% of its potential fullcapacityBattery charge below 25% Or < 25%Repack kit required If “Final Check” process was completed using the “Yes”daughter processCapnometer cannula required If Capnometer was started during the incidentGlucometer repack kit required If the glucometer repack process was followedThermometer battery required If the thermometer battery low error was reported duringincidentGlucometer battery required If the glucometer battery low was reported during incidentSoftware update required If software update was notified during incident*Device fault reported If any device was disabled due to a fault*If a software update is required you should refer to your maintenance manual for instructionson how to perform this process.
Tempus IC User/Operator ManualPage 69 41-1001-049 After Using the Tempus ICNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly what it requires.9.1 Cleaning the Tempus ICIt 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 otherLCD screens. Under no circumstances should any abrasive substance be applied to thescreen.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. Itshould be wiped down with a soft cloth, which may optionally be dampened with water and amild detergent solution.The screen may be cleaned using a proprietary screen cleaning wipe of the type used for otherLCD screens. Under no circumstances should any abrasive substance be applied to thescreen.The outer case of the Tempus IC should be cleaned to remove any cosmetic contamination. Itshould be wiped down with a soft cloth, which may optionally be dampened with water and amild detergent solution.9.1.1 Cleaning the ThermometerThe probe is the most delicate part of the thermometer. It should be used with care whencleaning 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 onthe end of the thermometer.2. Allow the probe to fully dry for at least 1 minute before using it.9.1.2 Cleaning the GlucometerIf the GlucoTel is used according to its instructions, only minor cleaning is necessary.For best results perform the following:1. Use a damp cloth for cleaning the entire surface of the instrument.2. After maintenance check the meter with control solution to ensure that it is functioningproperly.3. The GlucoTel or labeling will not be damaged or permanently discolored by cleaning withalcohol (70%), bleach (1:10) or ammonia (1:10)4. Checking the operation of the meter is recommended after each cleaning.This can be done using the control solution.
Tempus IC User/Operator ManualPage 70 41-1001-049.2 Cleaning and Re-packing Help ScreenThe user can get help at any time by pressing the button at any time. This will bring up theHelp Menu. There are multiple sequential menus covering different aspects of using the deviceWhen the first Help Menu is on the screen, the next menu (Cleaning and Repacking Menu) canbe accessed by pressing the Next touchscreen button.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 useWARNING: Keep wipes away from open flameNOTE: 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 withinternal bodily fluids (other than sweat). If such soiling has occurred, the itemshould not be used and should be returned to RDT.Example of the Help MenuThe user can press any one of the following icons on the touch screen to get help cleaning andrepacking the device.Example of the Cleaning and Repacking MenuFrom the HelpMenu, press theNext button tobring up theCleaning andRepacking Menu
Tempus IC User/Operator ManualPage 71 41-1001-04The user can move backwards and forwards through the iAssist help processes by pressing theNext 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 andfinishing with Final Check. It is important that you always perform the Final Check process.Suitable cleaning wipes labelled "Alcowipe" are provided within the Tempus IC. The helpscreen shows the location of the wipes and the user must follow the instructions provided onthe iAssist help process to clean and repack the device.9.3 Single-Use DevicesThe following accessories are single-use devices and must be discarded after use. Noparticular precautions are required when disposing of these items provided that they are notcontaminated with bodily fluids. In case of such contamination, the items should be disposedof in accordance with local regulations.Part Description:AlcoWipesNail Varnish WipesCapnometer cannulaeGlucometer stripsLancetsGloves
Tempus IC User/Operator ManualPage 72 41-1001-0410 Maintenance, Servicing andTroubleshooting10.1 GeneralThe Tempus IC is designed to be as maintenance-free as possible. The only user-replaceableand 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. 41-1002which 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 bescrapped. Scrapping the device and its accessories must be performed incompliance with applicable local regulations. It should be noted that specialconditions may apply to the rechargeable battery if it is required to bescrapped. The battery should be discharged before scrapping and should notbe crushed or incinerated.10.2 Battery Management10.2.1 The BatteryThe Tempus IC contains a removable, rechargeable battery.Example of the Battery Front
Tempus IC User/Operator ManualPage 73 41-1001-04Example of the Battery RearIn normal usage, the rechargeable battery provides power for at least 4 hours' continuous* usewhen fully charged.Every battery is provided with an integral battery life indicator which is also visible through thefront panel of the case.The battery life should be monitored periodically over time when the device is in storage andalso before and after use.NOTE: RDT recommends that the battery charge status should be checked once ayear and recharged if necessary. RDT also recommends that the battery becompletely discharged and recharged once a year.NOTE: The User should remember that battery life of older batteries will not be thesame as new batteries.By monitoring the remaining battery life, situations where the battery is too weak to power theTempus IC for the duration of an incident can be avoided. If the battery strength indicatorshows less than 25% power remaining, you should change the battery if possible to ensure thatthere 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 ordamage 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 ManualPage 74 41-1001-0410.2.1.1 Checking the Charge of the BatteryExample of the Battery Life Indicator Showing Full ChargeThe 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 morelights. Each light corresponds to 25% of the charge state of the battery in the order (fromhighest 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 ifthe 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 BagPressing the battery button behind the window will light one to four coloured lights.Window to checkthe battery
Tempus IC User/Operator ManualPage 75 41-1001-04The Tempus IC does not need to be removed or turned on to check the battery.10.2.2 Removing the Battery from the Tempus ICTo replace the battery:1 First check the replacement battery has sufficient charge by checking its indicator.Example of the Battery Indicator2 Next, ensure the Tempus is switched off. Then remove the battery by squeezing thetwo latches inwards, then pull the battery away.WARNING: Do not short-circuit the terminals of any battery. A short circuit can occur if thebattery terminals come into contact with any metal or other electricallyconductive 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 pressingand holding the power button for two seconds.NOTE: Remember that the battery cannot be removed until the red lamp on the frontpanel 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 ManualPage 76 41-1001-04Fitting the Battery10.2.3 Charging the BatteryThe battery can be charged either when it is fitted to the Tempus IC or when it is removed fromthe separate battery charger.WARNING: Do not attempt to charge the battery using any charger other than thosesupplied by RDT.10.2.3.1 Charging the Battery when Attached to the Tempus IC1. When fitted to the Tempus IC, the battery can be charged by connecting the powersupply (part number 01-1017) to the 3 pin connector on the right hand side of theTempus.The PSU Plug Attached to the Tempus IC Connector2. When the power supply is attached to the Tempus IC, the green power light on theTempus IC front panel will turn on.3. If a battery is attached the green charge light will flash. The lights on the battery willlight solidly up to the charge state of the battery at the time.
Tempus IC User/Operator ManualPage 77 41-1001-04The Power Light and the Charge LightNOTE: 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 isbeing used. If the Tempus is switched off charging will be faster than if theTempus is on and all features are being used.NOTE: Charging a completely empty battery will take 6 hours when the Tempus IC isswitched off.10.2.3.2 Using the Battery ChargerWhen the battery is separate from the Tempus IC, the battery may be charged by connecting itto the battery charger (part number 01-1012). To attach the charger to the battery, the clipmust be firmly pressed onto the connections of the battery. Note that the clip of the chargercan only be connected to the battery in one way.The Battery Connector Attached to the Battery1. 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 yellowduring charging (at approximately 86-100% charge) and will turn green when finished. If thebattery 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.BatteryCharge LightPower Light
Tempus IC User/Operator ManualPage 78 41-1001-0410.2.4 Tempus IC Battery Shelf Life10.2.4.1 Shelf Life of Batteries Stored as SparesA new and fully charged battery retains approximately 70% of its charge after 12 months instorage detached from the Tempus IC. This equates to approximately 4 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. Shelflife ratings are based on new, fully charged packs which are stored separatelyfrom the device at 20C. Shelf life performance will decrease over time and willbe lower if the battery is stored in higher or lower ambient temperatures.10.2.4.2 Shelf Life of Batteries Stored in the Tempus ICA new and fully charged battery retains approximately 60% of its charge after 12 months instorage attached to the Tempus IC. This equates to approximately 3.5 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. Shelflife ratings are based on new, fully charged packs which are stored separatelyfrom the device at 20C. Shelf life performance will decrease over time and willbe lower if the battery is stored in higher or lower ambient temperatures.10.2.5 Other Tempus IC Batteries10.2.5.1 Wireless Headset BatteryThe 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’sbattery becomes completely exhausted and can no longer hold charge, a replacement headsetcan be purchased.10.2.5.1.1 Charging the HeadsetRDT 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 willinstruct you to clean the headset after use and to replace it on its docking pin before shuttingdown.If you do not replace the headset then the Tempus will show an error advising that the headsetshould be refitted.Placing the headset onto the docking pin enables the Tempus IC to recharge it. The TempusIC recharges the headset for up to 4 hours 30 minutes (apx) every time the headset isreplaced. 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 onthe headset will light red for the duration of the charging process although it may switch offintermittently for 8 second periods (this is part of the charging process). The indicator light willgo off when charging is complete – which could be less than the 4 hour 30 minute maximumcycle 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 (apx).The Tempus IC will not recharge the headset battery if the main battery is nearly empty (lessthan 5% charge).Caution: Do not attempt to charge the headset using any other charging device. Thiswill 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Do not drop or try to alter the shape of your headset.
Tempus IC User/Operator ManualPage 79 41-1001-04Do not expose the headset to liquid or moisture. Unlike the Tempus, the headset hasno protection against ingress of solids or liquids.Do not expose your headset to extreme temperatures. The temperature range of theheadset is 0-40C.Do not try to disassembly your headset. Service and Maintenance can only beperformed by RDT.Do not let children play with the headset since it contains small parts that couldbecome detached and create a choking hazard.CAUTION: Danger of explosion if battery is incorrectly replaced. Do not attempt to repairor replace the battery. If the battery is worn out a new headset is requiredfrom RDT. Dispose of the headset in accordance with local regulations. Donot dispose as household waste.The user manual for the Bluetrek®G3 headset is supplied on the same CD-ROM as thismanual. Details from that manual have been reproduced in this section courtesy of Bluetrek®.10.2.5.2 The Glucometer BatteriesThe glucometer is powered by user replaceable non-rechargeable batteries. The batteries areconventional types that are available from common retail and industry sources.The glucometer is powered by 2 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 airlineapplication (once a week). Higher levels of usage (e.g. in a training department) may requirethe batteries to be changed more often.RDT recommends that Varta PowerOne alkaline batteries are used, although many other typesare commonly available. Replacement batteries do not need to be sourced from RDT.10.2.5.2.1 Changing the Glucometer BatteryTo change the glucometer battery:First push back the battery coverRemoving the Glucometer Battery CoverThen remove the batteries and dispose of them.Then replace the batteries with new units of the same type and ratings. Note that thebatteries must be inserted in the orientation shown on the inside of the plastic case ofthe device.
Tempus IC User/Operator ManualPage 80 41-1001-0410.2.5.3 The Thermometer BatteryThe thermometer is powered by a user replaceable non-rechargeable battery. The battery is aconventional 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 batteriesto be changed more often.RDT recommends that Varta batteries are used, although many other types are commonlyavailable. Replacement batteries do not need to be sourced from RDT.10.2.5.3.1 Changing the Thermometer BatteryTo change the thermometer battery:First push back the battery coverRemoving 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 thebattery must be inserted in the orientation shown on the inside of the plastic case of thedevice.10.2.6 Disposal of BatteriesDispose of batteries in accordance with the applicable local regulations (these can vary fromcountry to country).44In most countries, the trashing of used batteries is forbidden and the end-users are invited to dispose themproperly, eventually through not-for-profit profit organisations, mandated by local governments or organised on avoluntary basis by professionals.
Tempus IC User/Operator ManualPage 81 41-1001-0410.3 TroubleshootingOccasionally, problems may occur with the Tempus IC. Operator error, sensor problems or afailure within the Tempus IC could cause these problems. In most instances, the Tempus ICwill display an error message on the screen. This section describes the possible errormessages 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 withinthis manual e.g. Windows applications errors, turn the Tempus IC off and thenon 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 symptomspersist, please contact RDT10.3.1 ErrorsWhen the device encounters a problem it will display a dialog on the screen. The speaker willannounce the message “Attention” followed by the name of the part of the product that themessage 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 theerror 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 MessageAttention PulseOximeter There is a fault with the Pulse OximeterIt has been disabledAttentionCapnometerCapnometer is blocked.Disconnect and reconnect the cannula.Check the cannula for blockages, or kinks.AttentionCapnometerThe cannula is not plugged into the capnometer.Repeat step 7 of the instructions.AttentionCapnometer There is a fault with the CapnometerIt has been disabledAttentionCapnometerCapnometer is not plugged in.Repeat step 2 of the instructions.AttentionCapnometer Capnometer sensor error or range error.AttentionCapnometerCapnometer zero required.Sop and restart Capnometer.AttentionCapnometer No Capnometer is available on this unit.Attention BloodPressure MeterThere is a fault with the BP meter.It has been disabledAttention ECG An error occurred with the ECGPlease restart the ECG and try againAttention ECG There is a fault with the ECGIt has been disabledAttention Battery There is approximately 60 minutes of battery remaining
Tempus IC User/Operator ManualPage 82 41-1001-04Audio Message Text MessageAttention 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 is flat, the device will shut downAttention Connection Tempus is already trying to make a connectionAttention 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 surethis is what you want to do?Attention Connection Response centre is not respondingAttention Headset The headset has not connected to the Tempus.Repeat step 3 of the instructions.Attention Connection Headset should be replaced before shutdownAttention Connection You have not completed the data connection process. Are you surethis is what you want to do?Attention Connection You have not completed the voice connection process. Are you surethis 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 problempersists please contact your supplier.Attention ShutdownDue to low room temperature Tempus cannot be used and willshutdown. Please allow to warm and restart later.Attention Shutdown Due to high room temperature Tempus cannot be used and willshutdown. Please allow to cool and restart later.Attention Shutdown The battery is empty. Tempus will perform a managed switch-off. Thebattery should be changed.Attention Headset Please wait, setting up connection to the headset.Attention – Headset Headset should be replaced before shutdownErrorA fault has occurredTo clear the problem Tempus will switch offPlease switch back on once the shut-down is complete.If the problem persists please contact your supplierAttention Battery The battery is empty.Tempus will perform a managed switch-off.The battery should be changed.Attention Headset Please wait setting up connection to Headset10.3.2 Thermometer ErrorsThe thermometer display can show a range of error conditions and feedbackmessages. The thermometer display should be referred to during its use toensure that this information is seen and responded to.
Tempus IC User/Operator ManualPage 83 41-1001-04Error Message Problem SolutionDevice stabilization in process.Repeat the reading (after flashinghas stopped) but wait a fewseconds after the thermometerhas been inserted into the earbefore you press themeasurement buttonBattery is low and no moremeasurements are possible.Replace the battery.Measurement before devicestabilization.Repeat the reading (after flashinghas stopped) but wait a fewseconds after the thermometerhas been inserted into the earbefore you press themeasurement buttonThe device showing a rapidambient temperature change.Allow the thermometer to rest in aroom for at least 30 minutes atroom temperature: 10°C and40°C.The ambient temperature is notwithin the range between 10°Cand 40°C.Allow the thermometer to rest in aroom at least 30 minutes at roomtemperature: 10°C and 40°CError 5~9, the system is notfunctioning properly.Unload the battery, wait for 1minute and repower it. If themessage reappears, contact theretailer for service.Temperature taken is higher than42.2°C.Check the integrity of the probecover and take a new temperaturemeasurement.Temperature taken is lower than34°C.Make sure the probe cover isclean and take a new temperaturemeasurement.Device can not be powered on tothe ready stage.Change with a new battery.10.3.3 Glucometer ErrorsThe glucometer display can show a range of error conditions and feedbackmessages. The glucometer display should be referred to during its use toensure that this information is seen and responded to.
Tempus IC User/Operator ManualPage 84 41-1001-04Error Message Problem SolutionLo Reading is below 20 mg/dl (1.1mmol/l). Check calibration and retryreading.Hi Reading is above 525 mg/dl (29.2mmol/l). Check calibration and retryreading.E50 Internal meter temperature toolow. Allow the meter to warm up toroom temperature.E51 Internal meter temperature toohigh. Allow meter to cool to roomtemperature.E63 Strip removed during countdown. Test again and leave strip in themeter until a result is displayed.E70 Cell phone pairing failed. Repeat pairing process.
Tempus IC User/Operator ManualPage 85 41-1001-0411 Spares List11.1 Spares List of the Tempus ICThe following user-replaceable accessories and consumables are available from the RDT.01-1001 Battery Pack01-1002 Blood Pressure Cuff – Adult01-1003 Blood Pressure Cuff – Large Adult01-1004 Blood Pressure Cuff – Child01-1005 Lo-Flo®Capnometer01-1006 Blood Pressure Hose01-1007 Capnometer Cannula - Adult Nasal01-1008 Pulse Oximeter Sensor01-1009 Extension Reel01-1010 12 Lead ECG Harness01-1011 Bluetooth®Thermometer01-1012 Battery Charger01-1013 Bluetooth®Glucometer01-1014 Dual Modem Cable01-1015 Mains Cable Pack01-1016 Bag (empty)01-1017 Mains Power Supply01-1018 Bluetrek®Headset01-1019 Wired Headset01-1020 Consumables Replenishment Kit01-1021 Ethernet Cable01-1022 USB Serial Cable01-1023 Ethernet – POTS adaptor01-1024 Glucometer replenishment kit01-1025 ECG wrist straps01-1027 Glucometer Control Solution Set02-1001 Accessory Pouch (note – only supplied to commercial airlines)
Tempus IC User/Operator ManualPage 86 41-1001-0412 Configuring the Tempus ICNOTE: The iAssist help processes on your Tempus IC may differ from this exampleiAssist help process in the following sections. However the process alwaysfollows the same key elements.NOTE: Always ensure that you read the complete iAssist help process in order and doexactly 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 theSettings menu press Cleaning and Repacking touchscreen button followed by pressing theSettings touchscreen button.The Help MenuThe Cleaning and Repacking MenuPress the Settings button in the Cleaning & Repacking Menu on the touchscreen to bring upthe Settings Menu.Press thetouchscreenherePress thetouchscreenhere
Tempus IC User/Operator ManualPage 87 41-1001-04Settings MenuPress the Settings button in the Settings Menu on the touchscreen to bring up theconfigurable options.System SettingsPress the touchscreen to select the configurable parameters and press OK touchscreen buttonto confirm the changes you have made.Press thetouchscreenhere to configurethe devicePress thetouchscreenherePress thetouchscreenhere for the maindevice settings
Tempus IC User/Operator ManualPage 88 41-1001-04Configuration InformationThe configuration of the device can be seen in the configuration screen. .
Tempus IC User/Operator ManualPage 89 41-1001-0413 Specifications and Standards13.1 SpecificationsNote that all figures quoted are based on room temperature, pressure and humidityunless otherwise stated.13.1.1 Non-invasive Blood Pressure13.1.1.1 Adult cuff and Large Adult cuff ratingsSystolic: 60 - 250 mmHgDiastolic: 40 - 220 mmHgRange: 0 - 330 mmHgAccuracy: ± 3mmHg or ± 2% (whichever is greater)Resolution: 1 mmHgMaximum inflation: 330mmHg13.1.1.2 Child cuff ratingsSystolic: 60 - 250 mmHgDiastolic: 40 - 220 mmHgRange: 0 - 330 mmHgAccuracy: ± 3mmHg or ± 2% (whichever is greater)Resolution: 1 mmHgMaximum inflation: 330mmHg13.1.2 ECG RecorderGain/Sensitivity 5, 10, 20 mm/mVInput Range ±6mVAcquisition sample rate 1000 samples per second (compressed to500Hz with peak picking and averagingalgorithm)Frequency response 0.05 to 175Hz ±3dBDefibrillator protection Patient leads are isolated from system andoperator, with 4kV protectionCommon Mode Rejection -60dB (minimum)Leads Off Indicators Connection status for each lead is shown onAcquisition screenPermanent Filters High Pass: 0.05Hz 1st orderLow Pass: 170Hz 1st orderBaseline Wander: Baseline reset by adaptivezeroing algorithmNotch filter (Mains Noise Rejection) 50Hz 4th order Butterworth,49.1Hz - 50.9Hz,60Hz 4th order Butterworth,59.1Hz - 60.9HzLow pass (Muscle Artifact Filter) 35Hz 4th order
Tempus IC User/Operator ManualPage 90 41-1001-0413.1.3 ETC02SensorUnless otherwise stated, all CO2measurements are made following an airway adapter zero,with 5% CO2gas, balance N2at 25 degrees C, and Pb = 760 mmHg with 2 litres per minuteflow. The stabilization time for full specification testing of the LoFlo Module over the entiretemperature range is 20 minutes.Range: 0-100 BPMAccuracy: ± 2 BPMRange: 0-10% CO2 displayed valueAccuracy: ± 4%Rise time: <2 secondsDelay time: 5 secondsOperating altitude range: 0-15000 feetThe 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 MonitoringMode of Sampling SidestreamPrinciple of Operation Non-dispersive infrared (NDIR) single beam optics, dualwavelength, no moving parts.Initialization Time Measurement displayed in less than 20 seconds, At anambient temperature of 25° C, full specifications within 2minutes.CO2Measurement Range 0 to 150 mmHg 0 to 19.7% 0 to 20 kPa (Barometric Pressuresupplied by RDT Ltd)CO2Calculation Method BTPS (Body Temperature Pressure Saturated)CO2Response Time <3 seconds - includes transport time and rise timeCO2Resolution 0.1 mmHg 0 to 69 mmHg 0.25 mmHg 70 to 150 mmHgCO2Accuracy * 0 - 40 mmHg ± 2 mmHg41 - 70 mmHg ± 5% of reading71 - 100 mmHg ± 8% of reading101 - 150 mmHg ± 10% of readingAbove 80 breath per minute ± 12% of reading* NOTE: Gas temperature at 25° C.CO2Stability Short Term Drift: Drift over four hours shall not exceed 0.8mmHg maximum. Long Term Drift: Accuracy specification willbe maintained over a 120 hour period.CO2Noise RMS noise of the sensor shall be less than or equal to 0.25mmHg at 5% CO2Sampling Rate 100 HzRespiration Rate Range 2 to 150 breaths per minute (BPM)Respiration RateAccuracy ± 1 breathCalibration No routine user calibration required.
Tempus IC User/Operator ManualPage 91 41-1001-04Carbon Dioxide MonitoringETCO2Calculation Method: Peak of the expired CO2waveformSelections: 1 breath, 10 second, 20 secondInspired CO2Measurement Range: 3 to 50 mmHgMethod: lowest reading of the CO2waveform in the previous20 secondsSelection: 20 seconds (not user-selectable)Compensations (RDT LtdControlled) Compensations for: Expired O2, Balance gas (N2, N2O, He)and Anaesthetic AgentsBUses gas compensation information and barometric pressureto correct the raw carbon dioxide valueO2Compensation Range: 0 to 100%Resolution: 1%Default: 16%Airway Pressure Range:+ 120 cmH2O (88.27 mmhg)- 45 cmH2O (33.1 mmHg).Anaesthetic Agent SensitivityA(uncompensated) Accuracy specification will bemaintained for halogenatedanaesthetic agents present ataccepted MAC (MinimumAlveolar Concentration)clinical levels.Anaesthetic Agent Effects(MAC levels)Anaesthetic Agent Sensitivity(compensated) Testing at Agent levelsdefined by acceptedregulatory standards (i.e. ISO21647, ASTM F1456,IEC/CDV 60601-2-55)currently in process.Cross-sensitivityCompensation Error* 0-40 mmHg: ± 1 mmHg additional error41-70 mmHg: ± 2.5% additional error71-100 mmHg: ± 4% additional error101-150 mmHg: ± 5% additional error* Additional worst case error when compensation for Pb, O2,N2O, anaesthetic agents, or helium is correctly selected for theactual fractional gas constituents present.Gas or Vapour Halothane Enflurane Isoflurane DesfluraneMAC Level %(v/v) 0.74 1.68 2.00 6.30(From Olivier C. Wenker: Review of Currently Used Inhalation Anesthetics: Part I. The InternetJournal of Anesthesiology, 1999, Volume 3 Number.)Gas or Vapour Gas Level Quantitative EffectsNitrous oxide 60% No Additional Effect
Tempus IC User/Operator ManualPage 92 41-1001-04Gas or Vapour Gas Level Quantitative EffectsHalothane 4% No Additional EffectEnflurane 5% No Additional EffectIsoflurane 5% No Additional EffectSevoflurane 5% No Additional EffectXenon 80% Negatively bias Carbon Dioxide valuesby up to an additional 5 mmHg at 38mmHgHelium 50% No Additional EffectMetered dose inhalerpropellants Unspecified UnspecifiedDesflurane 15% Concentrations greater than 5% willpositively bias Carbon Dioxide values byup to an additional 3 mmHg at 38mmHg.Ethanol 0. 1% No Additional EffectIsopropanol 0.1% No Additional EffectAcetone 0.1% No Additional EffectMethane 1% No Additional EffectEnvironmental:Temperature andHumidity Operating 0 to 40°C, 10 to 90% RH, non-condensingStorage -40 to 70°C, 10 to 90% RH, non-condensingWater Resistance IPX4 - Splash-proof - Module only (When Sample Cell isinserted into Sample Cell Receptacle)Shock Impact IEC TR 60721-4-7 Class 7M3 (designed to withstandenvironments subject to significant vibrations or high shocklevels)EN60068-2-27 ShockEN60068-2-64 Random Vibration13.1.4 Sp02SensorPulse Range: 25-300 bpmGraphic display range: 25-175 bpmAccuracy: ± 2bpm or ±2% whichever is greaterResolution: 1bpmAveraging: 8 seconds
Tempus IC User/Operator ManualPage 93 41-1001-04SpO2 Range: 0-100%Graphic display range: 50-100%Accuracy: ±2% at 70%-100%Resolution: 1%Type: Functional saturation (test methods available uponrequest)Wavelength range: Red 660nm, infra-red 905nmPerfusion Index range: 1-20%Signal strength range: 1-7 bars13.1.5 ThermometerTemperature 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), RH85% (non-condensing)Transportation temperature: <70°C, RH95% (non-condensing)Compliance with: ASTM E1965-98, EN12470-5:2003 Clinicalthermometers-Part 5:Performance of infra-red earthermometers(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 equivalentRange: 10m (free field)Weight: 100g (including battery)Battery: 3V CR2Size: 167mm x 39mm x 45mm (max).Environmental range: The thermometer has the same environmental rangeas the Tempus IC, see section 13.1.7Drop/Shock: The thermometer has been tested to the same rangeof environmental standards as the Tempus IC (seesection 13.1.7.1RDT recommends that the batteries are replaced annually when used in a commercial airlineapplication (once a week). Higher levels of usage (e.g. in a training department) may requirethe batteries to be changed more often.The Thermometer uses the Bluegiga WT12A Bluetooth®module. This is unmodified by RDTand 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 of0.00222W.Bluetooth®SpecificationDescription Specification NoteOperatingfrequency range (2400 ... 2483,5) MHz ISM Band
Tempus IC User/Operator ManualPage 94 41-1001-04Bluetooth®SpecificationDescription Specification NoteRange Class 2, range up to 10 meters in an open fieldLower guard band 2 MHzUpper guard band 3,5 MHzCarrier frequency 2402 MHz ... 2480 MHz f = 2402 + k,k = 0...78Modulation method GFSK (1 Mbps)P/4 DQPSK (2Mbps)Hopping 1600 hops/s, 1 MHz channel spaceGFSK: Asynchronous, 723.2 kbps / 57.6 kbpsSynchronous: 433.9 kbps / 433.9 kbpsP/4DQPSK:Asynchronous, 1448.5 kbps / 115.2 kbpsSynchronous: 869.7 kbps / 869.7 kbpsMaximum data rate8DQPSK: Asynchronous, 2178.1 kbps / 177.2 kbpsSynchronous: 1306.9 kbps / 1306.9 kbpsReceiving signalrange-82 to -20 dBm TypicalconditionReceiver IFfrequency 1.5 MHz CenterfrequencyMin -11 ... -9 dBmMax +14 ... +18 dBmTransmissionpowerRSS210 22mW emission designation 1M21G2DCompliance Bluetooth®specification, version 2.0 + EDRCertification/ComplianceFCC: Part 15, FCC ID QOQWT12Industry Canada license 5123A-BGTWT12E13.1.6 GlucometerBatteries: The GlucoTel meter requires 2 * AAA Batteries(rechargeable batteries should not be used in theGlucoTel meter).Operating Temperature Range: 0 to +40 C. (32F to 104F)Storage Temperature Range: -20 to +55 C. (-4F to 131F)Accuracy: ±5.6%Operating Humidity Range: 20% - 80% RH (relative humidity),Storage Humidity Range: 10% - 90% RH (relative humidity).Measuring Range: 20 to 525 mg/dl or 1.1 to 29.2 mmol/lTransmission range: 3m in an open field when held by the user
Tempus IC User/Operator ManualPage 95 41-1001-04Automatic Switch On: Upon insertion of test stripAutomatic Switch Off: The GlucoTel meter turns off automatically after 60seconds and when the test strip is removed.Size: 140 x 30 x 18 mmWeight: 65g (including batteries).The glucometer is provided by BodyTel Inc. of Germany. Its specifications are detailed in itsuser manual which is provided on the CD-ROM with this manual.RDT recommends that the batteries are replaced annually when used in a commercial airlineapplication (once a week). Higher levels of usage (e.g. in a training department) may requirethe batteries to be changed more often.The glucometer uses the same Bluegiga WT12A Bluetooth®module that is detailed in section13.1.5.13.1.7 Environmental SpecificationsAltitude: 0-4500m (0-15000ft)(can be used at higher physical altitudes provided thelocal atmosphere is no higher than 4500m, e.g. in apressurised aircraft cabin)Relative humidity: 15%-95% (non-condensing)Operating temperature range: 0ºC to 40ºCStorage temperature range: -20ºC to +60ºCNOTE: Note that the IP sealing has a warranty of 1 year.NOTE: IPX6 and MIL810F tests are lab tests and not normal condition. The unitremains intact and functional after tests but rough handling may degradeperformance specification i.e. if you hit it with steel ball then IP sealing aroundthe case may degrade, if you drop it from 1.2m then IP sealing may degradeand a drop tests may damage peripherals. Drop test performancespecifications relate to a standalone device with no cables connected.13.1.7.1 Environmental Performance and CertificationTemperature & Altitude:Category: A1Test Standard, Temperature, RTCA/DO-160E Section 4, Para 4.5.1,4.5.2 and 4.5.3Test Standard, Altitude, RTCA/DO-160E Section 4, Para 4.6.1 and 4.6.2Temperature: Operating: 0°C to +40°C Storage: -20°C to +60°CShort Term High: +40°CAltitude: Operating: Sea Level to 15,000 ftStorage: Sea Level to 15,000 ftRapid Decompression: 10,000 ft to 55,000 ft in 10 secondsTemperature Variation:Test Standard: RTCA/DO160E Section 5 Cat CRate of Variation: 2°C per minute.Humidity:Test Standard: RTCA/DO-160E Section 6 Cat AStorage: 15 to 95% RH Non-condensing (tested for 48 hoursat 38-50C)
Tempus IC User/Operator ManualPage 96 41-1001-04Operating: 15 to 95% RH Non-condensing (tested at the end ofthe storage cycle)Operational Shocks & Crash Safety:Test Standard: RTCA/DO-160E Section 7 Cat BOperational Shock: Para 7.2 (6g for 11ms saw-tooth wave, repeated 3times in all axis).Crash Safety: 20g in all directions (sustained and impulse).Vibration:Test Standard: RTCA/DO-160E Section 8 Para 8.5.2Jet aircraft test Procedure: Curve B3, 3hrs per axis (repeated for allaxis) –10 Hz to 31 Hz at 0.02 g2/Hz Falling to 0.002 g2/Hzat 100 Hz 100 Hz to 500 Hz at 0.002 g2/Hz Falling to0.00013 g2/Hz at 2000 HzHelicopter test Procedure: Curve F, 0.5hrs per axis (repeated for allaxis) –5 Hz to 40 Hz at a ramp rate of +3 dB/Oct to a levelof 0.05 g2/Hz at 40 Hz 40 Hz to 200 Hz at 0.05 g2/HzRamping from 200 Hz to 300 Hz at a ramp rate of -12dB/OctProcedure: Curve F1, 3.5hrs per axis (repeated for allaxis) –5 Hz to 40 Hz at a ramp rate of +3 dB/Oct to a levelof 0.10 g2/Hz at 40 Hz 40 Hz to 200 Hz at 0.10 g2/HzRamping from 200 Hz to 300 Hz at a ramp rate of -12dB/OctExplosion 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 deviceIPX4 (hoop) – capnometerIPXX (no classification) – glucometer, thermometer,power supply, battery charger, headsetFluids 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.
Tempus IC User/Operator ManualPage 97 41-1001-04Magnetic 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 harmonicsEN61000-3-3:1995 inc A1:2001 & A2:2005 MainsflickerEN61000-4-11:2004 voltage dips and interruptionsVoltage Spike:Not tested to RTCA/DO160E Section 17.Commercial qualification: EN61000-4-4:2004 Fast transient burstsAudio Frequency Conducted Susceptibility – Power inputs:Not tested to RTCA/DO160E Section 18.Commercial qualification: EN61000-4-5:2006 SurgesInduced Signal Susceptibility:Not tested to RTCA/DO160E Section 19.Commercial qualification: EN61000-4-6:1996 inc A1:2001 Conducted RF fieldRadio Frequency Susceptibility (Radiated & Conducted):Not tested to RTCA/DO160E Section 20.Commercial qualification: EN61000-4-3:2002 Radiated RF InterferenceEmission 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 ESDFire and Smoke Hazards:Main case material: Glass reinforced nylon PA66+35%GF.Flame: UL94V-0
Tempus IC User/Operator ManualPage 98 41-1001-04Overmould material: TPE.Flame: N/A13.1.8 Miscellaneous Features and SpecificationsTempus IC dimensions 289mm wide x 203mm high x 101mm deep.13.1.8.1 Rechargeable batteryBattery life At least 6 hours running in normal use.Nominal voltage 7.4VCharging voltage 8.4V ±1%Nominal capacity 7.8AhWeight 0.42kg nominalShelf life Approximately 70% remaining after 1 year (before thecharge indicator light turns to Amber)Battery shelf life andrun times are based on a new, fullycharged batterystored in normal room ambient conditions. Run time is basedon RDT’s model of typical device usage in an incident.13.1.8.2 Battery ChargerMains input voltage 100-240VFrequency 50-60HzInput current 0.9A max (at 100V apx)Output voltage 8.4V dcOutput current <2.73ACharge time (from empty) 6 hoursNOTE: Only the RDT Battery Charger pn 01-1012 can be used with the Tempus IC.13.1.8.3 Mains Power SupplyMains input voltage 100 - 240VFrequency 50-60HzInput current 1.5A - 0.55AOutput voltage 12V dcOutput current 5ANOTE: Only the Cincon Electronics TR60M12 as supplied by RDT can be used withthe Tempus IC.13.1.8.4 GPSAntenna IntegralChannels 20 satellites simultaneouslySensitivity Up to -159dBmAccuracy ±30m (±2.5km with <6 satellites – labelled as“Approximate Fix”13.1.9 Communications13.1.9.1 Transmission ratesECG data and digital pictures take an appreciable amount of time to send to the ResponseCentre, approximate times are as follows:
Tempus IC User/Operator ManualPage 99 41-1001-04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 ofthe connection.13.1.9.2 WiFi SpecificationThe 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 and2.484Hz.The WiFi technology has the following features:WiFi SpecificationThe WiFi module has the following specifications:SKU # North America WL6231-1123International WL6233-1125Transmit Power CCK: 12 dBm typicalOFDM: 9 dBm typical63mW emission designation 11M5F9W tospec RSS210Indoor Range ~ 300 feet (typical office environment)Data Rate: 802.11a 54 Mbps OFDM: 9 dBm +1/-1.5 dBm802.11g 54 Mbps OFDM: 11 dBm +1/-1.5dBm802.11 b 11 Mbps CCK: 15 dBm +1/-1.5 dBmFrequency Range: North America: 2.412-2.462 GHz, channels1-11Europe ETSI: 2.412-2.472 GHz, channels 1-13Japan: 2.412-2.484 GHz, channels 1-14Security Encryption/AuthenticationHardware Support: WEP 64/128, WPA (TKIP/AES), WPA2(TKIP/AES)13.1.9.3 Bluetooth®SpecificationBluetooth®SpecificationDescription Specification NoteOperatingfrequency range (2400 ... 2483,5) MHz ISM BandRange Class 1, range up to 100 meters in an open fieldLower guard band 2 MHzUpper guard band 3,5 MHz
Tempus IC User/Operator ManualPage 100 41-1001-04Bluetooth®SpecificationDescription Specification NoteCarrier frequency 2402 MHz ... 2480 MHz f = 2402 + k,k = 0...78Modulation method GFSK (1 Mbps)P/4 DQPSK (2Mbps)Hopping 1600 hops/s, 1 MHz channel spaceGFSK: Asynchronous, 723.2 kbps / 57.6 kbpsSynchronous: 433.9 kbps / 433.9 kbpsP/4DQPSK:Asynchronous, 1448.5 kbps / 115.2kbpsSynchronous: 869.7 kbps / 869.7 kbpsMaximum data rate8DQPSK:Asynchronous, 2178.1 kbps / 177.2kbpsSynchronous: 1306.9 kbps / 1306.9kbpsReceiving signalrange-82 to -20 dBm TypicalconditionReceiver IFfrequency 1.5 MHz CenterfrequencyMin -11 ... -9 dBmMax +14 ... +18 dBmTransmissionpowerRSS210 22mW emission designation 1M21G2DRF inputimpedance 50Compliance Bluetooth®specification, version 2.0 + EDR13.1.9.4 Bluetooth®Headset SpecificationThe Tempus IC uses the Bluetrek®G3 wireless headset. This is unmodified by RDT and isprovided under FCC ID QITBTG3 under FCC part 15C and under AusCom approval N1342It operates in the frequency bands 2402MHz – 2480MHz and has a maximum power of0.00297W.Wireless Performance SpecificationsDescription Transmitter ReceiverOperating frequency range 2402 - 2480 MHz 2402 - 2480 MHzType of modulation FHSS modulation FHSS modulationNumber of channels 79 79Channel separation 1MHz 1MHzType of antenna Ceramic typeAntenna gain (dBi) 0Power level Fixed
Tempus IC User/Operator ManualPage 101 41-1001-04Description General SpecificationsBluetooth®type V1.2 class 2Range 10m max in an open fieldWeight 12gSize 67.5mm x 19.5mmTalk time Up to 13 hours*Stand by time Up to 400 hours**Based on the manufacturer’s specification – can be 12.5 hours in HV3, 10 hours in HV2 and5.3 hours in HV1 modes (HV level set by host device).Battery shelf life andrun times are based on a new, fullycharged battery.13.1.9.5 FCC & Industry Canada Notes on Wireless CommunicationsFCC ID: ROSTEMPUSIC-1CAUTION: Do not disassemble the device. There are no user-serviceable parts inside.Refer servicing to the manufacturer. Changes or modifications notexpressly approved by RDT could void the user’s authority to operate theequipment.This equipment has been tested and found to comply with the limits for a Class B digitaldevice, 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 aresidential installation.This equipment generates, uses and can radiate radio frequency energy and, if not installedand used in accordance with the instructions, may cause harmful interference to radiocommunications. However, there is no guarantee that interference will not occur in aparticular installation.If this equipment does cause harmful interference to radio or television reception, which canbe determined by turning the equipment off and on, the user is encouraged to try to correctthe 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 thereceiver 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 causeundesired operation of the device.This equipment is also ETS 300 328, ETS 300 826, ETS 300 328-2, ETS EN301 489-1 andETS EN301 489-17 compliant. These limits are designed to provide reasonable protectionagainst 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-TVInterference Problems. This booklet is available from U.S. Government Printing Office,Washington, D.C. 20402.Radio Frequency Interference Requirements – CanadaThis Class B digital apparatus meets the requirements of the Canadian Interference-CausingEquipment Regulations.13.1.9.6 Ethernet SpecificationThe Ethernet connection has the following specifications:
Tempus IC User/Operator ManualPage 102 41-1001-04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 100m13.1.9.7 Modem SpecificationThe Tempus IC contains two modems which can be connected to a telephone network via theRJ-45 connector. The modems are used either:together over 2k4baud channels (typically Inmarsat classic satcoms for aero or maritimeapplications 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 datasimultaneously.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).13.1.9.8 USB-Serial Adaptor SpecificationThe 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 suchas Iridium (data only) or Sat B (voice and data).Data speeds of from 9600baud.13.1.9.9 GSM & GPRS SpecificationThe Cell Phone (GSM) technology used by the Tempus has the following specifications:GSM/GPRS SpecificationOperatingfrequency rangeParameter Min Max UnitGSM 850 824 849 MHzE-GSM 900 880 915 MHzGSM 1800 1710 1785 MHzFrequency RangeUplink (MS → BTS)GSM 1900 1850 1910 MHzGSM 850 869 894 MHzE-GSM 900 925 960 MHzGSM 1800 1805 1880 MHzFrequency RangeDownlink (BTS → MS)GSM 1900 1930 1990 MHzRF power Parameter Min Max UnitGSM 850 31 35 dBmE-GSM 900 31 35 dBmGSM 1800 28 32 dBmRF power @ARPwith 50ゴLoadGSM 1900 28 32 dBmNumber of carriers Band ChannelsGSM 850 124E-GSM 900 174GSM 1800 374
Tempus IC User/Operator ManualPage 103 41-1001-04GSM 1900 299Duplex Spacing Band TypicalGSM 850 45 MHzE-GSM 900 45 MHzGSM 1800 95 MHzGSM 1900 80 MHzCarrier Spacing 200 KHzMultiplex, Duplex TDMA / FDMA, FDDTime Slots Per TDMAFame 8Frame duration 4.615mSTime Slot duration 577ųSModulation GMSKReceiver inputsensitivity @ ARPBER Class II < 2.4%(static input level)Parameter Min Typ UnitGSM 850 -1023-1074dBmE-GSM 900 -1023-1074dBmGSM 1800 -1023-1074dBmGSM 1900 -1023-1074dBmNote: Users are reminded that the cell phone is only for use outside northAmerica. Use of the GSM/GPRS radio in north America is subject to aplanned regulatory submissionNote: This device contains GSM 900 MHz and GSM 1800MHz functions that arenot operational in U.S. Territories.13.1.10 Tempus IC Device ClassificationThe system is classified according to the requirements of EN60601-1:1990 inc. A13:1996, thestandard for Medical Electrical Equipment, Part 1, General Requirements for Safety, Clause 5as:5.1 The Tempus IC is Internally (battery) powered – when powered by an external powersupply it is class II as defined by the classification labelled on the power supplyspecified and supplied by RDT. The thermometer is internally (battery) powered.5.2 Applied parts type CF defibrillator proof, thermometer classified as BF, glucometer isnot classified as it is an IVD rather than a medical device.5.3 The Tempus IC is rated IPX6, protected against rainfall according to IEC529. Thecapnometer is rated IPX4. All other parts are rated IPXX.5.4 No parts supplied sterile or suitable for/requiring sterilising5.5 Equipment not suitable for use in the presence of a flammable anaesthetic mixturewith air or with oxygen or nitrous oxide5.6 Suitable for continuous useNote 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,
Tempus IC User/Operator ManualPage 104 41-1001-04not suitable for use in the presence of a flammable anaesthetic mixture with air or withoxygen or nitrous oxide,is intended for intermittent use (it measures discrete readings rather than being usedcontinuously) – 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 isbecause the glucometer is classified as an IVD (invitro-diagnostic device) rather than a patientapplied medical device.13.1.11 Standards ComplianceThe Tempus IC complies with the applicable parts of the following standards:Standard TitleIEC 60601-1 2nd edition:1988Amendment A1:1993,A11:1993, A12:1993,A1:1995, A13:1996Medical electrical equipment: General requirements for safety (asamended)IEC 60601-1-1:2000 –reference standard only Medical electrical equipment -- Part 1-1: General requirements forsafety - Collateral standard: Safety requirements for medicalelectrical systemsIEC 60601-1-2:2005 Medical electrical equipment -- Part 1-2: General requirements forsafety - Collateral standard: Electromagnetic compatibility -Requirements and testsIEC 60601-1-4:1996Amendment A1:1999Medical electrical equipment -- Part 1-4: General requirements forsafety - Collateral standard: Programmable electrical medicalsystems (as amended)IEC 60601-1-6:2004 Medical electrical equipment -- Part 1-1: General requirements forsafety - Collateral standard: UsabilityIEC 60601-2-25:1993Amendment A1:1999Medical electrical equipment -- Part 2-25: Particular requirementsfor the safety of electrocardiographsIEC 60601-2-30:1999 Medical electrical equipment -- Part 2-30: Particular requirementsfor the safety, including essential performance, of automaticcycling non-invasive blood pressure monitoring equipmentIEC 60601-2-49:2006 Medical electrical equipment -- Part 2-49: Particular requirementsfor the safety of multifunction patient monitoring equipmentISO 21647:2004ISO 21647:2004/AC:2006Medical electrical equipment - Particular requirements for the basicsafety and essential performance of respiratory gas monitors (asamended)ISO 9919:2005 Medical electrical equipment - Particular requirements for the basicsafety and essential performance of pulse oximeter equipment formedical useISO 14971:2007 Medical devices - Application of risk management to medicaldevicesEN 60529:1992 Specification for degrees of protection provided by enclosures (IPcode)
Tempus IC User/Operator ManualPage 105 41-1001-04Standard TitleEN 980:2008 Graphical symbols for use in the labelling of medical devicesEN 1041:1998 Information supplied by the manufacturer of medical devicesISO 10993-1: 2003 Biological evaluation of medical devices - Part 1: Evaluation andtestingRTCA/DO160E Environmental conditions and test procedures for airborneequipmentUL 1642 Issue 4 Standard for lithium batteries13.1.11.1 EMC InformationThe following tables provide information required to be provided under IEC60601-1-2.Cable Length of the Sensors and the AccessoriesRDT PartNumberCableLength(typ.)TestedLengthEthernet cable 01-1021 2.1m 2.1mSpO2 sensor 01-1008 1.5m 1.5mECG harness 01-1010 1.5m 1.5mCapnometer 01-1005 0.5m 0.5mWired headset 01-1019 1.2m 1.2mMains Power supply 01-1017 0.45m 0.45mMains lead 01-1015 2m 2mWARNING: The use of longer cable lengths may cause an increased emission or areduced interference resistance. The use of other sensors or cables except theones mentioned above is not allowed.Manufacturer's Declaration - Electromagnetic Emissions (Tab. 201 according to DIN EN60601-1-2)The Tempus IC is intended for use in an electromagnetic environment as described below. Thecustomer or user of the device should ensure that the device is used in such an environment.EmissionMeasurements Compliance Electromagnetic EnvironmentHF emissions acc. toCISPR11 Group 2 The Tempus IC must emit RF energy in orderto perform its function. Nearby electronicdevices may be affected.Note that the Tempus IC can be configuredfor not to emit RF energy in which case it willbe group 1 and will not be likely to cause anyinterference in nearby electronic equipment.HF emissions acc. toCISPR11 Class B The Tempus IC is intended for use in allfacilities including living quarters and suchones which are connected directly to a publicpower supply that supplies also buildingsused for living purposes.
Tempus IC User/Operator ManualPage 106 41-1001-04EmissionMeasurements Compliance Electromagnetic EnvironmentEmission of overtonesacc. to IEC61000-3-2 Class AEmission of voltagefluctuation/flicker acc.to IEC61000-3-3CompliesManufacturer's Declaration - Electromagnetic Emissions (Tab. 202 according to DIN EN60601-1-2)The Tempus IC is intended for use in an electromagnetic environment as described below. Thecustomer or user of the device should ensure that the device is used in such an environment.InterferenceResistance Test IEC 60601 TestLevel Compliance Level ElectromagneticEnvironment -GuidelinesElectrostaticdischarge (ESD) acc.to IEC 61000-4-2± 6 kV contactdischarge± 8 kV air discharge± 6 kV contactdischarge± 8 kV air dischargeFloors should be ofwood, concrete orceramic tiles. If thefloor is tiled withsynthetic material therelative air humiditymust have 30 % atleast.Fast transient electricdisturbances / burstsacc. to IEC 61000-4-4± 2 kV for powerlines± 1 kV for input andoutput lines± 1 kV for input andoutput lines The quality of thesupply voltage shouldconform to a typicalbusiness or clinicenvironment.Surge voltageacc. to IEC 6100-4-5 ± 1 kV normal modevoltage± 2 kV commonmode voltage± 1 kV normal modevoltage± 2 kV commonmode voltageMains power should bethat of a typicalhospital or commercialenvironment.Voltage drops, shortinterruptions andvariations in supplyvoltage acc. toIEC 61000-4-11< 5 % UT(>95 %break of UTfor 0,5period40 % UT(60% breakof UT) for 5 periods70 % UT(30% breakof UT) for 25 periods< 5 % UT(>95 %break of UTfor 5seconds< 5 % UT(>95 %break of UTfor 0,5period40 % UT(60% breakof UT) for 5 periods70 % UT(30% breakof UT) for 25 periods< 5 % UT(>95 %break of UTfor 5secondsMains power should bethat of a typicalhospital or commercialenvironment. If theuser of the Tempus ICrequires continuedoperation during powerinterruptions then thebattery may be usedfor periods up to 6hours or a UPS maybe used.Magnetic field at thesupply frequency(50/60 Hz) acc. toIEC 61000-4-83 A/m 3 A/m Magnetic fields at thesupply frequencyshould conform to thetypical values as theyoccur in the businessor clinic environment.NOTE UTis the AC mains voltage before the use of testing levelsManufacturer's Declaration - Electromagnetic Interference Resistance (Tab. 204according to DIN EN 60601-1-2)
Tempus IC User/Operator ManualPage 107 41-1001-04The Tempus IC is intended for use in an electromagnetic environment as described below. Thecustomer or user of the device should ensure that the device is used in such an environment.InterferenceResistance Test IEC 60601Test Level ComplianceLevel Electromagnetic Environment –GuidelinesConducted RFdisturbances acc.toIEC61000-4-6Radiated RFdisturbances acc.to IEC61000-4-33 Vrms150 KHz to80 Mhz3 V/m80 MHz to 2,5GHz3Vrms3VrmsPortable and mobile RFcommunications equipment shouldbe used no closer to the deviceincluding the cables than it isrecommended by the equation forthe frequency.Recommended safety distance:d = 1.2√Pd = 1.2√P for 80MHz to 800 MHzd = 2.3√P for 800 MHz to 2,5 GHzP is the nominal power of thetransmitter in watt (W) according tothe specifications of the transmittermanufacturer; d is therecommended safety distance inmeters (m).The field strength of stationarytransmitters should be lower thanthe Compliance level for allfrequencies according to a testingon location.Disturbances are possible neardevices 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 ofelectromagnetic values is influenced by absorptions and reflections of buildings, objects andpeople.a) The field strength of stationary transmitters such as fixed parts of cellular phones and mobileradio sets, amateur radio stations, AM and FM radio and television cannot be determinedexactly in theory. To detect the electromagnetic environment in regard to stationarytransmitters a study of the location should be considered. If the measured field strength at thelocation where the device is being used exceeds the Compliance level above the device shouldbe watched to verify the proper functions. If unusual features are watched additional actionsmight 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 10V/m.Recommended Safety Distances between portable and mobile RF TelecommunicationDevices 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 RFdisturbances. The user of the device can help to avoid electromagnetic disturbances bykeeping the minimum distance between portable and mobile telecommunication devices(transmitters) and the device - depending on the output power of the telecommunicationdevices as described below.Safety Distance Depending on the Frequency in m
Tempus IC User/Operator ManualPage 108 41-1001-04Safety Distance Depending on the Frequency in mNominal power of thetransmitterW150 kHz to 80 MHzd = 1.2√P80 MHz to 800 MHzd = 1.2√P800 MHz to 2,5 GHzd = 2.6√P0,01 0.12 0.12 0.230,1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters with a maximum nominal power not mentioned above: To detect therecommended safety distance use the equitation in the corresponding column. P is themaximum nominal power of the transmitter in watt (W) according to the specifications of thetransmitter 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 ofelectromagnetic values is influenced by absorptions and reflections of buildings, objects andpeople.
Tempus IC User/Operator ManualPage 109 41-1001-0414 Symbols Used on the Tempus ICThe following symbols are used on the Tempus IC:Symbol DescriptionDefibrillation proof type CF applied part,Type BF applied part. The thermometer is not proof against theeffects of a cardiac defibrillator discharge.Attention, consult accompanying documentsBattery Charge indicator – flashes green when the battery is onchargeBattery power levelSystem power on/off (push/push)Date of manufacture, where the year that the item wasmanufactured is represented by the year and then the monthe.g. 2002 06 is June 2002.Single use device only, discard item after useIPX6 The device is proof against a hose according to IEC529YYYY-MM
Tempus IC User/Operator ManualPage 110 41-1001-04Symbol DescriptionThe device has been declared by the manufacturer to be inaccordance with the requirements of the European UnionMedical Devices Directive 93/42/EEC as transposed by UKnational legislation.Shelf life, where the time that the unit must be used by isrepresented by the year and then the month e.g. 2004 06 isJune 2004.LOT YYYY - MMWhere the year that the item was manufactured as a part of alarger 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 mustbe disposed of as electrical and electronic waste.Communications connectionsWiFi connection mode to response centreBluetooth®connection to medical modulesBattery Connection – to indicate positive terminal polarityGlobal Positioning System (GPS)YYYY - MM
Tempus IC User/Operator ManualPage 111 41-1001-04Symbol DescriptionGlobal System for Mobile (GSM) communicationsHeadset connectorPower Status (green indicates mains power is connected)Camera BacklightDevice contains wireless transmittersDC connector
Tempus IC User/Operator ManualPage 112 41-1001-0415 End User License AgreementThis 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 ofit, may result in severe civil and criminal penalties, and will be prosecuted to the maximumextent possible under the law.You acknowledge that you will read and adhere to the user manual and ensure that usersreceive proper training from RDT or an appropriately trained individual. You also acknowledgethat you will maintain the software by installing new software updates supplied by RDT within 5working 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 theterms and conditions of this agreement. You will not share the program with other parties andwill keep the program and details of its functions confidential. You will ensure that access tothe 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, GSMor satellite links and the Internet. RDT does not accept liability for the failure of these links toreliably transmit information from RDT’s products. Users are reminded that it is theirresponsibility to ensure that GSM network and other communications contracts are maintainedand 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 assatellite communications, GSM or a telephone line and other types of links. It is yourresponsibility to maintain these communications links. Such links may have security or othermeasures implemented on them such as firewalls. It is your responsibility to ensure that anysuch firewalls or other elements of the communication link are configured correctly to allow datafrom Tempus IC to communicate over said link. RDT does not accept any responsibility forfailure to transmit data or to transmit data reliably over such links if they have not beenconfigured correctly. Support on configuring such links can be obtained from RDT uponrequest.Neither the Tempus IC or RDT are a "covered entity" under the Health Insurance Portabilityand Accountability Act of 1996 and the regulations promulgated thereunder ("HIPAA"). As aresult, HIPAA does not apply to the transmission of health information by RDT or Tempus IC toany third party.The software gives users the ability to share and transmit medical data with third parties. Suchactivities 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 lossof data, loss of revenue or for any incidental or consequential damages incurred arising out ofor relating to the use of this software product. Some jurisdictions do not allow the exclusion ofimplied warranties, so the above exclusion may not apply to you. This warranty gives youspecific 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 fitnessof 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 tonotify customer of such a revision.You acknowledge that you have read this agreement, understood it, and agree to be bound byits terms and conditions.Failure to enforce any provision will not constitute a waiver of that provision. If any provision isfound unenforceable, it and any related provisions will be interpreted to best accomplish theunenforceable provision's essential purpose.
Tempus IC User/Operator ManualPage 113 41-1001-04This agreement is governed by UK law. The exclusive venue for any dispute relating to thisagreement 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 MedicThis license covers QRS Pocket Medic software.Warning: The software contained herein is protected by copyright law andinternational treaties. Unauthorized reproduction, distribution or reverse engineeringof 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 thissoftware.· You may transfer the program and license to another party if the party agrees toaccept the terms and conditions of this agreement. If you transfer the software youmust turn over all copies of the software to the same party or destroy any copies nottransferred.Limited Warranty and Remedies:In no event shall QRS Diagnostic, LLC or the distributors of "Pocket Medic", be liablefor any damages resulting from loss of data, loss of revenue or for any incidental orconsequential damages incurred arising out of or relating to the use of this softwareproduct. Some jurisdictions do not allow the exclusion of implied warranties, so theabove exclusion may not apply to you. This warranty gives you specific legal rightsand you may have other rights that vary from region to region.QRS Diagnostic, LLC and its distributors MAKE NO REPRESENTATIONS withrespect to the merchantability or fitness of "Pocket Medic" and the product is sold "asis", without any warranty of any kind. The only exception is the 60-day warrantyextended for replacement of defective disks. Further, QRS Diagnostic, LLC, reservesthe right to revise its publications and program(s) without obligation to notify customerof such a revision.You acknowledge that you have read this agreement, understood it, and agree to bebound by its terms and conditions; you further agree that it is the complete andexclusive statement of the agreement between us which supercedes any proposal orprior agreement, oral or written, and any other communications between us relating tothe subject matter of this agreement.
Tempus IC User/Operator ManualPage 114 41-1001-0416 Change HistoryPage/Section Change Date/IssueN/A First release 005.2.4 Added section on GSM/ DPRS display 018.4 Section added on using the thermometer 018.5 Section added on using the glucometer 018.6 Information added on transmitting moving video 019.1.1 Section added covering cleaning of the thermometer 0110.2.5 Added section on batteries (headset, glucometer and thermometer) 0110.3.1 Section added on thermometer errors 0110.3.2 Section added on glucometer errors 0111 Added glucometer calibration kit as an accessory 0113.1.5 Specification section added for the thermometer. 0113.1.6 Specification section added for the glucometer. 0113.1.7.1 Environmental testing section added 0113.1.9 Expanded details of communications specifications 0113.1.10 Classification details updated to cover the thermometer and glucometer 0114 Added BF symbol for the thermometer 0115 Added EULA to section 15, moved change history to section 16 0231 Added Accessory Pouch 0338 Added information to section 7.2.1.1.2 on getting information on how toadjust the volume of the wireless headset. 0363 Added section 8.9 on GPS 0383 Added Accessory Pouch 0396 Added 13.1.8.4 for GPS specification 0399 Updated WiFi specification 04101 Updated FCC & IC numbers for Tempus IC 04102-103 Updated GSM specification 04

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