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

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Tempus IC
User/Operator Manual
Part number 41-1001
Copyright  2009, RDT L td. U K
Date of Issue: 6 November 2009
Tempus IC
User/Operator Manual
Contents
INTRODUCTION................................................................................................................5
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.7.1
2.4.1
2.4.2
2.4.3
2.4.4
2.4.5
Tempus IC Warnings, Cautions and Notes......................................................................................... 8
LoFlo Sidestream Capnom eter - Warnings, Cautions, & Notes...................................................... 15
Pulse Oximeter Sensor - Warnings, Cautions, & Notes .................................................................. 16
ECG Recorder Sensor - Warnings, Cautions, & Notes ................................................................... 17
The Blood Pressure M onitor - Warnings, Cautions, & Advers e Reactions.................................... 17
Product Description and List of Features................................................................19
INTRODUCTION TO THE TEMPUS IC ..........................................................................20
4.1
4.1.1
4.1.2
4.1.3
4.1.4
EMC Statement..........................................................................................................7
Indications for Use .....................................................................................................7
Contraindications .......................................................................................................7
Warnings, Cautions and Notes..................................................................................8
INTRODUCTION TO THE TEMPUS IC ..........................................................................19
3.1
Service Support and Returns ............................................................................................................... 6
WARNINGS AND CAUTIONS ..........................................................................................7
2.1
2.2
2.3
2.4
Manufacturer's Address.............................................................................................5
CE Statement.............................................................................................................5
FDA Prescription Statement......................................................................................5
Proprietary Notice ......................................................................................................5
Use of This Manual ....................................................................................................6
Patent Claims.............................................................................................................6
Limited Warranty ........................................................................................................6
Tempus IC Device....................................................................................................20
Tempus
Tempus
Tempus
Tempus
IC
IC
IC
IC
Front .................................................................................................................................. 20
Base .................................................................................................................................. 20
Rear................................................................................................................................... 21
Sides ................................................................................................................................. 21
USING THE TEMPUS IC.................................................................................................23
5.1
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.4
5.5
Controlling the Tempus IC.......................................................................................23
Explanation of the Tempus IC Screen.....................................................................27
Status Bar – Clock (Time Stamp)....................................................................................................... 27
®
Status Bar – Bluetooth Indicator....................................................................................................... 27
Status Bar - WiFi Indicator .................................................................................................................. 28
Status Bar – GSM/GPRS Indicator .................................................................................................... 28
Instrument Readings ........................................................................................................................... 28
Instrument Status Indicators ............................................................................................................... 29
Device Sensors ........................................................................................................29
Pulse Rate and Oxygen Saturation (SpO 2)....................................................................................... 29
Blood Pressure..................................................................................................................................... 29
Electrocardiograph (ECG)................................................................................................................... 29
End Tidal CO 2 (ETCO 2) and Respiration Rate ................................................................................ 30
Digital Camera..........................................................................................................30
Voice and Data Communications ............................................................................30
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User/Operator Manual
SETTING UP ....................................................................................................................31
6.1.1
6.2
6.3
Unpacking the Tempus IC .................................................................................................................. 31
Tempus IC Bag ........................................................................................................31
Switching On............................................................................................................33
6.3.1
Immediately after Switching On.......................................................................................................... 33
ESTABLISHING COMMUNICATION WITH THE RESPONSE CENTRE.....................35
7.1
7.2
Making the Phone Connection ................................................................................35
Fitting the Headset and Making the Voice Connection...........................................36
7.2.1
7.3
Using the Wireless Headset ............................................................................................................... 37
Connection Status Indicators...................................................................................40
7.3.1
7.4
Dialling Order and Indicators When Dialling ..................................................................................... 41
Communications Modes ..........................................................................................42
7.4.1
7.4.2
7.4.3
Changing M odes.................................................................................................................................. 42
Using Available M odes........................................................................................................................ 42
Changing the Connection M ode......................................................................................................... 42
TAKING MEDICAL READINGS......................................................................................45
8.1
Blood Pressure and Pulse Oximeter.......................................................................45
8.1.1
8.1.2
8.1.3
8.2
Understanding the Pulse Oxim eter Results ...................................................................................... 47
Understanding the Blood Pressure Results ...................................................................................... 47
Blood Pressure Monitor Error iAssist Help Process......................................................................... 48
Electrocardiograph (ECG) .......................................................................................48
8.2.1
8.2.2
8.3
Monitoring an ECG .............................................................................................................................. 50
Recording an ECG............................................................................................................................... 51
Capnometer..............................................................................................................52
8.3.1
8.4
Understanding the Capnometer Results ........................................................................................... 53
Thermometer............................................................................................................54
8.4.1
8.4.2
8.5
Using the Thermom eter ...................................................................................................................... 56
Understanding the Thermom eter Results ......................................................................................... 56
Glucometer...............................................................................................................57
8.5.1
8.5.2
8.6
Testing the Glucometer ....................................................................................................................... 59
Understanding the Glucom eter Results ............................................................................................ 59
Digital Camera..........................................................................................................60
8.6.1
8.7
Annotation of Digital pictures .............................................................................................................. 63
Interacting with the Response Centre .....................................................................63
8.7.1
8.7.2
The Response Centre ......................................................................................................................... 63
Remote Viewing and Control .............................................................................................................. 64
8.8 Recording Data Off-line and Transmitting On-line..................................................64
8.9 GPS Location...........................................................................................................65
8.10 Actions after Use – Turning the Tempus IC Off......................................................66
8.10.1
Logging M aintenance Requirements ............................................................................................ 67
AFTER USING THE TEMPUS IC....................................................................................69
9.1
9.1.1
9.1.2
9.2
9.3
Cleaning the Tempus IC ..........................................................................................69
Cleaning the Therm ometer ................................................................................................................. 69
Cleaning the Glucometer .................................................................................................................... 69
Cleaning and Re-packing Help Screen...................................................................70
Single-Use Devices..................................................................................................71
10 MAINTENANCE, SERVICING AND TROUBLESHOOTING.........................................72
10.1 General.....................................................................................................................72
10.2 Battery Management................................................................................................72
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Tempus IC
10.2.1
10.2.2
10.2.3
10.2.4
10.2.5
10.2.6
User/Operator Manual
The Battery ...................................................................................................................................... 72
Removing the Battery from the Tem pus IC .................................................................................. 75
Charging the Battery ....................................................................................................................... 76
Tempus IC Battery Shelf Life ......................................................................................................... 78
Other Tempus IC Batteries............................................................................................................. 78
Disposal of Batteries ....................................................................................................................... 80
10.3 Troubleshooting .......................................................................................................81
10.3.1
10.3.2
10.3.3
Errors ................................................................................................................................................ 81
Thermometer Errors ........................................................................................................................ 82
Glucom eter Errors ........................................................................................................................... 83
11 SPARES LIST ..................................................................................................................85
11.1 Spares List of the Tempus IC ..................................................................................85
12 CONFIGURING THE TEMPUS IC...................................................................................86
13 SPECIFICATIONS AND STANDARDS..........................................................................89
13.1 Specifications ...........................................................................................................89
13.1.1
13.1.2
13.1.3
13.1.4
13.1.5
13.1.6
13.1.7
Non-invasive Blood Pressure......................................................................................................... 89
ECG Recorder ................................................................................................................................. 89
ETC02 Sensor .................................................................................................................................. 90
Sp02 Sensor ..................................................................................................................................... 92
Thermometer ................................................................................................................................... 93
Glucom eter ...................................................................................................................................... 94
Environm ental Specifications ......................................................................................................... 95
Temperature & Altitude:......................................................................................................95
Temperature Variation: .......................................................................................................95
Humidity:..............................................................................................................................95
Operational Shocks & Crash Safety:..................................................................................96
Vibration: .............................................................................................................................96
Explosion Proofness:..........................................................................................................96
Water Proofness: ................................................................................................................96
Fluids Susceptibility: ...........................................................................................................96
Sand & Dust:.......................................................................................................................96
Fungus Resistance: ............................................................................................................96
Salt Spray:...........................................................................................................................96
Magnetic Effect: ..................................................................................................................97
Power Input: ........................................................................................................................97
Voltage Spike:.....................................................................................................................97
Audio Frequency Conducted Susceptibility – Power inputs:.............................................97
Induced Signal Susceptibility:.............................................................................................97
Radio Frequency Susceptibility (Radiated & Conducted): ................................................97
Emission of Radio Frequency Energy:...............................................................................97
Lightning Induced Transient Susceptibility:........................................................................97
Lightning Direct Effects:......................................................................................................97
Icing:....................................................................................................................................97
ESD: ....................................................................................................................................97
Fire and Smoke Hazards:...................................................................................................97
13.1.8
13.1.9
13.1.10
13.1.11
Miscellaneous Features and Specifications ................................................................................. 98
Communications.............................................................................................................................. 98
Tempus IC Device Classification ................................................................................................. 103
Standards Com pliance ................................................................................................................. 104
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14 SYMBOLS USED ON THE TEMPUS IC.......................................................................109
15 END USER LICENSE AGREEMENT............................................................................112
16 CHANGE HISTORY.......................................................................................................114
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Tempus IC
User/Operator Manual
Introduction
1.1
Manufacturer's Address
The Te mpus IC is designed and m anufactured by:
RDT Limited
The Old Coach House
The Avenue
Farleigh Wallop
Basingstoke
Hampshire
RG25 2HT
UK
Tel +44 (0) 1256 362 400
Fax +44 (0) 1256 362 415
Email sales@rdtltd.com
www.rdtltd.com
1.2
CE Statement
Marking by the
symbol indicates com pliance of this device to the Medical Devices
Directive 93/42/EEC and the Radio and Telecom Terminal Equipm ent Directive 1995/5/EC.
The CE mark is accompanied by the number 0473 which is the reference number for the
Notified Body who certify RDT’s quality system.
A Declaration of Conformity in accordance with the above regulations has been made and is on
file with RDT at the address in section 1.1.
1.3
FDA Prescription Statement
Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician.
1.4
Proprietary Notice
Information contained in this docum ent is copyright © 2009 by Remote Diagnostic
Technologies Limited ('RDT') and may not be reproduced in full or in part by any means or in
any form by any person without prior written perm ission from RDT.
The purpose of this document is to provide the user with adequately detailed inform ation to
efficiently install, operate, m aintain and order spare parts for the Tem pus IC. Every effort has
been made to keep the information contained in this document current and accurate as of the
date of publication or revision. However, no guarantee is given or implied that the docum ent is
error free or that it is accurate with regard to any specification. RDT reserves the right to
change specifications without notice.
Tempus IC
TM
TM
, i2i
TM
and TempusNET
are all tradem arks of RDT.
®
®
The Bluetooth name and logo are owned by the Bluetooth SIG Inc. and any use of this name
or mark is under license.
®
®
BodyTel and GlucoTel are protected by registered tradem arks and trademark applications of
BodyTel Europe Gmbh.
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Tempus IC
1.5
User/Operator Manual
Use of This Manual
The instructions and safety precautions provided in this m anual m ust be observed during all
phases of the operation, usage, service or repair of the Tempus or its accessories. Failure to
comply with the inform ation contained in this manual e.g. warnings, precaution, instructions etc.
will violate the safety standards of design, manufacture and intended use of the product. RDT
Ltd assum es no liability for customer failure to com ply with the inform ation contained in this
manual.
Users of Tempus IC and its accessories are advised to convey the following safety information
to operating personnel and to incorporate applicable information into their own internal
literature where necessary.
1.6
Patent Claims
RDT has applied for patents covering Tempus IC and its communications technology in the
following jurisdictions:
Patents Pending (US No.2006/0287586 EP 1734458 A & other areas).
1.7
Limited Warranty
Remote Diagnostic Technologies Lim ited ('RDT') warrants each new Te mpus IC to be free
from defects in workmanship and m aterials under norm al conditions of use and service. For
details please refer to the Terms and Conditions of Sale. Consumable items are expressly
excluded from this Warranty. RDT's sole obligation under this warranty will be to repair or (at
RDT's option) replace products that prove to be defective during the warranty period. The
foregoing shall be the sole warranty rem edy. Except as set forth herein, RDT makes no
warranties, either expressed or im plied, including the im plied warranties of merchantability and
fitness for a particular purpose. The warranty shall be void if Te mpus IC is in any way modified
or if it is used with non-approved consum ables, unless specifically authorised in writing by RDT,
and RDT shall not be liable in any event for incidental or consequential damage. This warranty
is not assignable.
Full terms and conditions of sale are available from RDT and are provided with your order
confirmation.
1.7.1
Service Support and Returns
Repairs m ade under warranty to Te mpus IC m ust be made by the manufacturer. If Te mpus IC
requires repair or return for any reason, please contact your local distributor or Remote
Diagnostic Technologies at the address in section 1.1 in order to first obtain a returns reference
(RMA) number. RDT reserves the right not to accept returns which have not first been
provided with an RMA num ber. When calling, please be ready to quote the serial number of
Tempus IC.
The Tempus IC is designed to be as maintenance free as possible. The only user replaceable
and user serviceable parts in the Tempus IC are those listed in section 10 of this manual.
In the event that the device fails to operate correctly or in a way that is not described in this
manual, stop using the device immediately and switch the device off immediately. Contact the
manufacturer or distributor at once. Do not attempt any kind of corrective action and do not
connect the device to a patient.
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Tempus IC
User/Operator Manual
Warnings and Cautions
2.1
EMC Statement
The Te mpus IC remote patient monitor has been tested and approved to IEC/EN60601-12:2007. This m eans that the Tempus IC meets or exceeds the requirem ents for electrical
medical equipment in terms of its levels of emitted electrom agnetic radiation and its
susceptibility to electromagnetic radiation from other devices.
In addition, the Te mpus IC has been tested according to the requirem ents of RTCA DO160-E
section 21 category M.
It should be noted that the Te mpus IC may be affected by high levels of stray EM radiation
from other electronic devices (even those which comply with relevant CISPR emission
standards) that are being used in close proxim ity to it.
As required by international medical device standards, the Te mpus IC is intended for use in
electrom agnetic environments of 6kV static contact (8kV air discharge) and magnetic fields
of 3A/m (50/60Hz). The Tempus IC is proof against radiated RF emissions from 80MHz to
2.5GHz to a level of 3V/m. In the event that the Te mpus IC will be used in environments with
RF levels exceeding this, please contact RDT for further inform ation.
2.2
Indications for Use
The Te mpus IC is intended to aid with the diagnosis of a person presenting as unwell or sick
when they are in a location rem ote from imm ediate m edical assistance. The device allows the
User to take vital signs data from a patient and to transmit that data to medical professionals
located at the response centre elsewhere. Typical examples are rem ote land, sea or air
locations.
The Te mpus IC is intended primarily to be used by medically unqualified people who have
received basic training in the use of the device. Medical expertise is provided through
communication with the Response Centre which would be staffed by physicians who would
advise the operator on the nature of the m edical incident.
The Te mpus IC is intended to be used where a physician or other medically trained staff m ay
or may not be present but where remote physician support is required.
The Te mpus IC is suitable for use on adults or children (over 10 years old and over 20kg in
weight).
2.3
Contraindications
The Te mpus IC is not intended to be used on extrem ely small or extremely large patients; this
limit is set by the physical limits of the ECG harness.
The Te mpus IC does not replace a physician’s care. The device is not intended for neonatal
use. The device is not an apnoea m onitor.
The Te mpus IC is not intended to be used in strong magnetic or electro-m agnetic fields which
are generated for medical purposes e.g. MRI. The Tem pus is not for use with electro-cautery
devices.
The Te mpus IC is not intended to allow a lay user to m ake any clinical decision for treatment or
diagnosis.
The Te mpus IC ECG is not intended to be used on patients with prosthetic limbs.
The Te mpus IC is not intended to be a long-term m onitor; it is only intended to be used in
short, discrete incidents where the immediate health of the patient is in question.
The Te mpus IC is not intended to, and does not sound alarms for physiological parameters.
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Tempus IC
2.4
User/Operator Manual
Warnings, Cautions and Notes
KEYWORD
DEFINITION
Indicates a potentially harmful condition that can lead to personal injury.
WARNING
Indicates a condition that may lead to equipm ent dam age or malfunction.
CAUTION
NOTE
2.4.1
A point of particular interest or em phasis intended to provide m ore
effective or convenient.
Tempus IC Warnings, Cautions and Notes
WARNING
It is essential to switch off the Tempus IC between applying it to
different patients in order to ensure patient records remain
separate.
WARNING:
The use of the
symbol indicates that the user m ust read the user manual
before using the product.
WARNING:
Only connect Tem pus IC to IT and communications systems which are
compliant with the relevant IEC standard e.g. IEC60950. Signal input and
output connectors are only for connection to equipment complying with relevant
IEC safety standards and m ust be configured to comply with IEC60601-1-1.
WARNING:
The user should not touch the patient at the same tim e as touching accessible
conductive parts of the Tem pus e.g. connectors.
WARNING:
Federal law (USA) restricts the use or sale of this device by, or on the order of,
a physician.
WARNING:
The Tempus IC is not intended for unsupervised patient monitoring. There are
no audible or visible alarms.
WARNING:
Do not use device in the presence of flammable anaesthetics or fuels.
WARNING:
Do not autoclave, ethylene oxide sterilise, or immers e in liquid or immersing the
sensors in liquid as it m ay cause sensor damage which m ay result in
inaccurate readings.
WARNING:
ELECTRICAL SHOCK HAZARD when covers are rem oved. Do not remove
covers. Refer servicing to qualified pers onnel authorised by RDT.
WARNING:
Device m ust be used in conjunction with clinical signs and symptoms. Device
is only intended to be an adjunct in patient assessment.
WARNING:
Attention should be paid to the following EMC inform ation prior to installing or
using the device.
WARNING:
Verify normal operation if utilizing device adjacent to or stacked with other
electrical equipment.
WARNING:
Portable and mobile Radio Frequency (RF) comm unication equipment m ay
interfere with the operation of the device.
WARNING:
The Tempus has been tested and found to comply with IEC/EN 60601-1-2.
WARNING:
Computers, cables and accessories not tested to IEC/EN60601-1-2 or
equivalent IEC standards m ay result in increased emissions or decreased
immunity of device.
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Tempus IC
User/Operator Manual
WARNING:
Follow precautions for electrostatic discharge (ESD) and electrom agnetic
interference (EMI) to and from other equipment.
WARNING:
Only use Tempus IC with the relevant cables and peripherals provided by RDT.
WARNING:
Exposure of the wireless comm unication features of the Tempus IC or its
accessories may be interfered with by other devices which operate at the sam e
frequencies.
WARNING:
The sensors of the Tempus IC are only for contact with intact and undamaged
skin.
WARNING:
Any device or accessory that has been dropped, dam aged or subjected to
hars h or extreme environm ental conditions should be inspected by qualified
service pers onnel prior to use to ensure proper operation.
WARNING:
The Tempus IC is not for use on neonates.
WARNING:
The device should not be used on patients undergoing defibrillation. The
Tempus IC is protected against defibrillator discharge but rate meters and
displays may be temporarily affected during defibrillator discharge but will
rapidly recover.
WARNING:
There is no defibrillator synchronisation output on the device. Make no
connections between the device and a defibrillator.
WARNING:
Device will not operate effectively on patients who are experiencing
convulsions or tremors.
WARNING:
Device is not for apnoea detection. Device has not been tested or validated for
use in apnoea detection.
WARNING:
Misuse or im proper handling of the device or its sensors or cables can cause
dam age which may lead to equipm ent failure or inaccurate readings.
WARNING:
Misuse or im proper handling of the device (its sensors or cables) can cause
dam age which may lead to equipm ent failure or inaccurate readings.
WARNING:
Do not attem pt to charge a non-rechargeable battery. Never charge, crush,
heat or incinerate, short-circ uit, deform, puncture, dismantle or immerse the
batteries in any liquid. Rem ove 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 the
possibility of patient entanglement or strangulation
WARNING:
All numerical, graphical and interpretive data should be evaluated with respect
to the patient's clinical and historical picture
WARNING:
Do not attem pt to insert any connections from the Tempus IC (including patient
cables) directly into an electrical outlet
WARNING:
Explosion Hazard: DO NOT use the Tem pus IC in the presence of flammable
anesthetics or other flammable gasses. Use of the Tempus IC in such
environment may present an explosion hazard.
WARNING:
Electrical Shock Hazard: Always disconnect the LoFlo sidestream Capnometer
before cleaning. Do NOT use if it appears to have been dam aged. Refer
servicing to qualified service pers onnel.
WARNING:
Failure of Operation: If the Tem pus IC fails to respond as described in this user
guide; DO NOT use it until approved for use by qualified personnel.
WARNING:
Reuse, disassem bly, cleaning, disinfecting or sterilizing of any single use items
(such as the capnom eter cannula) m ay compromise functionality and system
perform ance leading to a user or patient hazard. Perform ance is not
guaranteed if an item labelled as single patient use is reused.
WARNING:
Do not apply excessive tension to any cable.
WARNING:
Before use, carefully read these operating instructions.
WARNING:
Using a damaged patient sensor m ay cause inaccurate readings, possibly
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Tempus IC
User/Operator Manual
resulting in patient injury or death. Inspect each sensor. If a sensor appears
dam aged, do not use it. Use another sensor or contact your authorized repair
center for help.
WARNING:
Using a damaged patient cable may cause inaccurate readings, possibly
resulting in injury or death. Inspect the patient cable. If the patient cable
appears dam aged, do not use it. Contact your authorized repair center for
help.
WARNING:
The USB connection must only be connected to non-mains powered
peripherals (such as a mouse or keyboard) or to interface accessories provided
by RDT (such as the USB-Serial Cable pn 01-1022). Any connections made to
the USB port must be to medical or IT peripherals or communications systems
which comply with the applicable IEC safety standard (i.e. IEC60601-1 or
IEC60950). Any connection arrangem ents must be made in a manner
compliant with IEC60601-1-1.
CAUTION:
Do not disassemble the device. There are no user-s erviceable parts inside.
Refer servicing to the manufacturer. Changes or m odifications not expressly
approved by RDT could void the user’s authority to operate the equipm ent.
CAUTION:
Repairs or service activity not detailed in this m anual or in accompanying
docum ents must only be undertaken by personnel trained or authorized by
RDT.
CAUTION:
Autoclaving, ethylene oxide sterilizing, or immers ing the sensors in liquid may
cause sensor damage which may result in inaccurate readings.
CAUTION:
This device is intended for use by pers ons trained in professional health care.
The operator must be thoroughly familiar with the inform ation in this m anual
before using the device.
CAUTION:
The Tempus IC m ay not operate correctly if used or stored outside the relevant
temperature or hum idity ranges described in the performance specifications of
this m anual.
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 Tem pus IC cables.
CAUTION:
Read all instructions for use and specifications provided prior to use.
CAUTION:
Device is intended for use by pers ons trained in its operation. The operator
must be thoroughly familiar with the information in this manual before using the
device.
CAUTION:
The device is not intended to, and does not, sound alarms for physiological
parameters.
CAUTION:
In the event that the device displays an error that is not described within this
manual e.g. Windows applications errors, turn the device off and then on again.
This should clear the error and allow normal operation to resume. Do not
continue to use the device if such an error is displayed. If symptoms persist,
please contact RDT.
CAUTION:
Device m ust be switched off between taking readings from different patients.
CAUTION:
Should the device becom e wet, wipe off all moisture and allow sufficient tim e
for drying before operating. Take care to ensure that water or liquids are not
spilt over the device or into its ventilation holes in the side corners.
CAUTION:
If the accuracy of any measurement is in question, verify the patient's vital
sign(s) by an alternative method and then check the monitor for proper
functioning.
CAUTION:
Follow local government regulations and recycling instructions regarding
disposal and recycling of device and device components.
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User/Operator Manual
CAUTION:
The Tempus IC and its accessories use different types of batteries which
includes rechargeable and non-rechargeable types. If any battery fails to hold
a charge or otherwise becomes inoperable, the battery should be replaced and
the old battery should be disposed of properly. RDT cannot dispose of used
batteries. Dispose of batteries in accordance with applicable regulations which
vary from country to country.
(In m ost countries, the trashing of used batteries is forbidden and the endusers are invited to dispose them properly, eventually through not-for-profit
profit organisations, mandated by local governm ents or organised on a
voluntary basis by professionals).
CAUTION:
Pressing buttons and touch screen with sharp or pointed instruments may
perm anently dam age the buttons and touch screen. Only fingers should be
used to press these keys.
CAUTION:
Do not reconnect the headset to its docking pin when the m ain battery is very
low or flat (less than 10% charge – as represented by a single flashing red LED
on the battery charge indicator). Doing this could reduce the battery charge
into a “deep discharge” state (where no battery lights com e on).
CAUTION:
Only connect the device to communications systems which are compliant with
relevant international safety standards e.g. IEC60950 for IT and
telecommunications equipm ent. Only connect the device to comm unications
systems which it is intended to be used with.
CAUTION:
Do not touch electrically live parts of other electrical systems while touching the
patient.
CAUTION:
Use of monitoring during continuous nebulised m edication delivery will result in
dam age to the device which is not covered by the warranty. Disconnect the
capnometer sample line from the device, or switch off the device, during
medication delivery.
CAUTION:
Observe proper battery polarity (direction) when replacing batteries. The
batteries slide easily into place when correctly oriented and should not be
forced.
CAUTION:
The mobile RF communications equipment contained within the device and its
accessories can affect other m edical devices that are in close proximity to the
device.
CAUTION:
Use of the RF communications equipment contained in the device and its
accessories may be prohibited in a number of areas. These include: on aircraft
in-flight (including during take-off and landing), near defibrillators (that are in
use), near other electronic m edical devices and in hospitals.
CAUTION:
In addition, the use of the RF comm unications equipm ent contained in the
device and its accessories m ay be prohibited in explosive atmospheres e.g. in
fuelling areas, near fuel or chem ical transfer or storage areas and in areas
containing chem icals or particles such as grain, dust or metal powders.
CAUTION:
Do not transport or store the device with flammable gas, liquids or explosives.
CAUTION:
The use of the RF communications equipment contained in the device and its
accessories may cause interference with some im planted pacem akers and
other m edically im planted equipment.
A minimum distance of 2.3m (7.5 feet) must be maintained between the device
and its accessories (c ontaining RF communications equipm ent) and other
medical equipment (including im plantable medical devices such as defibrillators
and pacem akers). Note that if such medical equipment has an electromagnetic
interference immunity level of less than 3V/m (or 10V/m for implantable
devices), this distance should be increased in line with the requirements of
IEC60601-1-2:2007.
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If the intended patient has an im plantable device (e.g. implantable pacemaker),
do not use any of the Tem pus IC’s RF communications equipm ent (e.g.
®
Bluetooth or WiFi) before using the device to record the patient's physiological
data. After the data recording session is com pleted, move the device at least
2.3 m away from the patient, and then use it norm ally to communicate with the
base station. Otherwise, radiofrequency radiation from the device (up to
63mW) may adversely impact the im plantable pacem aker in the patient. If the
patient's implantable device has an immunity level less than 10 V/m, the
separation has to be greater than 2.3 m
If you suspect interference is being caused, disconnect the connection to the
response centre by pressing
. Exam ples of interference could include
visible interference on equipment displays, audible interference e.g. buzzing,
from speakers of other equipm ent, or equipment unexpectedly changing state
e.g. functions starting or stopping. Exam ples of visible interference on a PC
display are shown below:
Example of a PC display with no interference
Example of a PC display with interference
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This equipm ent complies with FCC RF radiation exposure limits set forth for an
uncontrolled environment. The antenna(s) used for this transmitter must be
installed to provide a separation distance of at least 20 cm from all persons and
must not be co-located or operating in conjunction with any other antenna or
transmitter except as defined in the FCC filing
CAUTION:
When using the device with portable satellite term inals such as Iridium
handsets or GAN term inals, ALW AYS ensure that the terminal is provided with
any applicable data adaptors and is set up to support data calls. It is
recommends that Users thoroughly familiarise themselves with the operation
their satellite terminals and perform a test connection BEFORE going into the
field with the equipment. Advice on this can be sought from RDT if required.
CAUTION:
When using the device with GAN terminals, in order to avoid the risk of
interference from the output beam from the antenna of the terminal with the
operation of the device, ALW AYS ensure that the device is situated at least 6m
behind the face of the antenna. Since the power of the GAN term inal’s beam is
high (25W apx), care should be taken to ensure that the antenna rem ains fixed
and to m aintain the device away from the face (and therefore the beam) of the
antenna.
CAUTION:
Do not reconnect the headset to its docking pin when the m ain battery is very
low or flat (less than 10% charge – as represented by a single flashing red LED
on the battery charge indicator). Doing this could reduce the battery charge
into a “deep discharge” state (where no battery lights com e on).
CAUTION:
RF energy m ay affect some electronic systems in motor vehicles, such as car
stereo, safety equipm ent, etc. Check with your vehicle manufacturer’s
representative to be sure that your product will not affect the electronic system
in your vehicle.
CAUTION:
Do not use the Tem pus IC’s Bluetooth or WiFi comm unications on-board any
aircraft where its use is prohibited.
CAUTION:
Do not use the Tem pus IC during take-off or landing
NOTE:
If all the battery lights remain off when the battery button is pressed, the battery
may be in a “deep discharge” state. The battery is not damaged when in this
state but will require an extended period on a charger (additional 2-3 hours) in
order to restore normal operation.
NOTE:
Im portant! The Tem pus IC is intended for use in the electromagnetic
environment(s) specified in this manual. Users of this equipm ent should ensure
that it is used in such environment(s).
NOTE:
The Tempus IC or its accessories contain no user serviceable parts except as
detailed by this manual or accom panying documents. Refer service to qualified
service pers onnel.
NOTE:
This product and its accessories are latex free.
NOTE:
After the life cycle of the Tempus IC and its accessories have been met,
disposal should be accomplished following national and/or local requirements.
NOTE:
Operation of the device may be adversely affected in the presence of
conducted electrical transients or strong electromagnetic or radio frequency
sources such as electrosurgery and electrocautery equipm ent, HF radio
transmission antenna, x-ray machines and high intensity infrared radiation.
NOTE:
All user and patient accessible m aterials are non-toxic.
NOTE:
Hazards arising from software errors have been minimised. Hazard analysis
was performed to m eet 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 in
section 1.1.
®
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NOTE:
Device complies with Part 68 of the US FCC Rules and the requirements
adopted by ACTA . The device is labelled with, am ong other information, a
product identifier in the form at US:AAAEQ###TXXXX. If requested, this
num ber must be provided to the telephone com pany.
NOTE:
A plug and jack used to connect the device to the prem ises wiring and
telephone network m ust com ply with the applicable FCC Part 68 rules and
requirements adopted by ACTA. A compliant telephone cord and modular plug
is provided with this product. It is designed to be connected to a com patible
modular jack that is also compliant.
NOTE:
The REN is used to determine the number of devices that may be connected to
a telephone line. Excessive RENs on a telephone line may result in the devices
not ringing in response to an incoming call. In most but not all areas, the sum of
RENs should not exceed five (5.0). To be certain of the number of devices that
may be connected to a line, as determ ined by the total RENs, contact the local
telephone com pany. For products approved after July 23, 2001, the REN for
this product is part of the product identifier that has the format
US:AAAEQ##TXXXX. The digits represented by ## are the REN without a
decim al point (e.g., 03 is a REN of 0.3). For earlier products, the REN is
separately shown on the label.
NOTE:
If the device causes harm to the telephone network, the telephone com pany
will notify you in advance that temporary discontinuance of service may be
required. But if advance notice isn't practical, the telephone company will notify
the customer as soon as possible. Also, you will be advised of your right to file
a com plaint 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 equipm ent. If
this happens the telephone company will provide advance notice in order for
you to m ake necessary modifications to maintain uninterrupted service.
NOTE:
If the equipm ent is causing harm to the telephone network, the telephone
company may request that you disconnect the equipm ent until the problem is
resolved.
NOTE:
Connection to party line service is subject to state tariffs. Contact the state
public utility commission, public service commission or corporation commission
for inform ation.
NOTE:
If your hom e or area of installation has specially wired alarm equipm ent
connected to the telephone line, ensure the installation of the device does not
disable your alarm equipment. If you have questions about what will disable
alarm equipment, consult the supplier as described in section 1.7.1.
NOTE:
This equipm ent is not hearing aid compatible.
NOTE:
ALWAYS ensure that any satellite terminals e.g. GAN or Mini-M terminals,
used with the device are powered from mains power supplies which are
earthed. Using a non-earthed power supply with satellite term inals will cause
interference on the ECG trace. Earthed power supplies will always have a
three pin connector to plug the m ains lead into, non-earthed power supplies will
always have the following sym bol on their label
. In addition, when
purc hasing any replacem ent power supplies for satellite terminals, always
ensure that the replacement has the sam e input and output voltage (V), current
(A) and power (W) ratings, the same type and polarity of output connector and
is approved to EN/IEC60950 (safety standard). Advice on this m atter m ay be
sought from RDT if needed.
NOTE:
GSM usage is restricted by the network availability, roaming agreem ents and
local provision of circ uit mode connections.
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User/Operator Manual
NOTE:
Users who own multiple device units should note that their device are likely to
be pre-configured for different aircraft, yachts or other locations according to
the customer’s needs. Consequently different device units owned by one User
may not necessarily be com patible with all of the customer’s different aircraft,
yachts etc. Users should refer to RDT’s delivery notes which will detail if
specific device is configured for specific applications. Alternatively please
check with a technical contact at RDT for confirm ation.
NOTE:
Users should not put the device into service until they have been trained in its
use and also (where appropriate) the device has been commissioned on their
aircraft, vessel or other intended site of operation.
NOTE:
IP sealing is not guaranteed if the device is subject to rough handling, im pact,
improper use, rapid decom pression
NOTE:
Device should be returned for service if it is subject to rough handling and IP
sealing is needed to be relied upon.
NOTE:
The Tempus IC’s water ingress seals are warranted for 1 year from the date of
manufacture.
NOTE:
The device specifications are subject to change without notice.
NOTE:
It is recommended that the device is connected to the response centre every
month for a test patch.
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from the example
iAssist help process used in this manual; however the process always follows
the same key elem ents.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
NOTE:
For optim um performance of the wireless communications, please make sure
that there is no m etal surrounding the Tempus IC.
NOTE:
Overbending the folding foot or RapdiPak clip could cause them to be
dam aged. Do not over-bend these items.
NOTE:
Take care when repacking cables to ensure they cannot be snagged or
dam aged in the RapidPak clip and the folding foot.
NOTE:
The Tempus IC should be repacked following the relevant instructions. Lost or
dam aged cables and accessories should be replaced with spares ordered from
RDT.
LoFlo Sidestream Capnometer - Warnings, Cautions, & Notes
WARNING:
Do not operate the LoFlo sidestream Capnometer if it fails to operate properly,
if it appears to have been dam aged or when it is wet or has exterior
condensation.
WARNING:
DO NOT use device on patients that can not tolerate the withdrawal of 50
ml/min +/- 10 ml/m in from the airway or patients that can not tolerate the added
dead space to the airway.
WARNING:
Do not connect the exhaust tube to a ventilator circ uit.
CAUTION:
DO NOT sterilize or immerse the LoFlo sidestream Capnometer in liquids.
CAUTION:
DO NOT store the LoFlo sidestream Capnom eter at temperatures less than 40º F (-40º C) or greater than 158º F (70º C).
CAUTION:
DO NOT operate the LoFlo sidestream Capnom eter at temperatures less than
32º F (0º C) or greater than 104º F (40º C).
CAUTION:
Remove the LoFlo sam pling kit sam ple cell from the receptacle when not in
use.
CAUTION:
DO NOT stick appendage into sam ple receptacle.
NOTE:
Recommended operating tem perature is 32º F (0º C) to 104º F (40º C).
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NOTE:
2.4.3
Nitrous oxide, elevated levels of oxygen, helium , Xenon, halogenated
hydrocarbons, and barometric pressure can influence the CO 2 measurem ent..
Pulse Oximeter Sensor - Warnings, Cautions, & Notes
WARNING:
Do not use this device in the presence of high EMI/RFI radiation. High EMI/RFI
radiation m ay cause induced current to the SpO 2 sensor resulting in patient
injury.
WARNING:
This device m ay give inaccurate readings in the presence of strong
electrom agnetic sources, such as electrosurgery equipment.
WARNING:
This device m ay give inaccurate readings in the presence of computed
tomography (CT) equipm ent.
WARNING:
This device m ust be used in conjunction with clinical signs and sym ptoms. This
device is only intended to be an adjunct in patient assessment.
WARNING:
Prolonged use or the patient’s condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours. Prolonged use m ay cause blisters,
skin deterioration, and discomfort.
WARNING:
Incorrectly applied sensors may give inaccurate readings.
WARNING:
SpO2 measurements may be inaccurate in the presence of high ambient light.
Shield the sensor area (with a towel, for example) if necessary.
WARNING:
Dyes introduced into the bloodstream , such as m ethylene blue, indocyanine
green, indigo carmine, patent blue V (PBV), and fluorescein m ay advers ely
affect the accuracy of the SpO 2 reading.
WARNING:
Any condition that restricts blood flow, such as use of a blood pressure cuff or
extrem es in systemic vascular resistance, may cause an inability to determine
accurate pulse rate and SpO 2 readings.
WARNING:
Remove fingernail polish or false fingernails using the wipe provided before
applying SpO 2 sensors. Fingernail polish or false fingernails may cause
inaccurate SpO 2 readings.
WARNING:
Significant levels of dysfunctional hemoglogins, such as carboxyhemoglogin or
methhem oglobin, will affect the accuracy of the SpO 2 m easurem ent.
WARNING:
Tissue damage may result from overexposure to sensor light during
photodynamic therapy with agents such as verteporphin, porfimer sodium and
metatetrahydroxyphenylchlorin (m THPC). Change the sensor site at least
every hour and observe for signs of tissue damage. More frequent sensor site
changes or inspections may be indicated depending upon the photodynamic
agent used, agent dose, skin condition, total exposure tim e or other factors.
Use multiple sensor sites.
WARNING:
Ethylene oxide sterilizing the sensor m ay lead to tissue damage when the
sterilized sensor is placed on a patient.
WARNING:
Optical cross-talk can occur when two or more sensors are placed in close
proxim ity. It can be elim inated by covering each site with opaque material.
Optical cross-talk m ay advers ely affect the accuracy of the SpO 2 readings.
WARNING:
Obstructions or dirt on the sensor’s red light or detector m ay cause a sensor
failure or inaccurate readings. Make sure there are no obstructions and the
sensor is clean.
WARNING:
Under certain clinical conditions, pulse oximeters m ay display dashes if unable
to display SpO 2 and/or pulse rate values. Under these conditions, pulse
oximeters may also display erroneous values. These conditions include, but
are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or
low pulse rates or a com bination of the above conditions. Failure of the
clinician to recognize the effects of these conditions on pulse oximeter readings
may result in patient injury.
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User/Operator Manual
CAUTION:
Unplug the sensor from the m onitor before cleaning or disinfecting to prevent
dam aging sensor or m onitor, and to prevent user safety hazards.
NOTE:
SpO2 averaging is the number of pulse beats over which the SpO 2 value is
averaged; pulse averaging is the num ber of seconds over which the pulse
value is averaged.
NOTE:
DESAT trails were perform ed in the normal sensitivity m ode.
NOTE:
Use proper disposal guidelines when discarding the device.
ECG Recorder Sensor - Warnings, Cautions, & Notes
WARNING:
The ECG device is not intended for use in a sterile environm ent. Do not use for
direct cardiac application.
WARNING:
The ECG device is reusable
WARNING:
Do not attem pt to insert the ECG device (including patient cables) into an
electrical outlet
WARNING:
The ECG is for resting recordings and should not be used in stress testing
environments
WARNING:
Ensure electrodes are connected only to the patient
WARNING:
Conductive parts of electrodes and connectors, including neutral electrode,
should not contact other conductive parts including earth
WARNING:
The Tempus IC is rated as being proof against the effects of a defibrillator
discharge. Follow these warnings if using an AED or defib with the Tempus IC:
− Follow the instructions of the defibrillator or AED when using it with the
Tempus IC.
− Do not touch the patient during defibrillation
− Do not touch the defibrillator’s paddle-electrode surface when discharging the
defibrillator
− Keep defibrillation electrodes well clear of other electrodes or metal parts in
contact with the patient
− Do not touch the patient, bed, or any conductive material in contact with the
patient during defibrillation
2.4.5
The Blood Pressure Monitor - Warnings, Cautions, & Adverse
Reactions
WARNING:
This device should not be used when oscillometric pulses may be altered by
other devices or techniques such as External Counterpulsation (ECP) or Intra
Aortic Balloon Pum p Counterpulsation.
WARNING:
DO NOT use the Blood pressure monitor for any purpose other than specified
in this manual.
WARNING:
DO NOT attach the cuff to a lim b being used for IV infusions as the cuff
inflation can block the infusion, potentially causing harm to the patient.
CAUTION:
Accuracy of any blood pressure m easurement may be affected by the position
of the subject, his or her physical condition and use outside of the operating
instructions detailed in this manual. Interpretation of blood pressure
measurements should be m ade only by a physician or trained medical staff.
CAUTION:
Hoses of a certain m aterial and/or durom eter may cause the module to perform
in an im proper fashion. Only use hoses provided by RDT.
CAUTION:
Incorrectly sized cuffs m ay cause m easurem ent inaccuracy or errors.
CAUTION:
If the blood pressure cuff is on the same lim b as a pulse oxim eter probe, the
oxygen saturation results will be altered when the cuff occludes the brachial
artery.
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CAUTION:
To obtain accurate blood pressure readings, the cuff must be the correct size,
and also be correctly fitted to the patient. Incorrect size or incorrect fitting m ay
result in incorrect readings.
CAUTION:
When a cuff is going to be positioned on a patient for an extended length of
time, be sure to occasionally check the limb for proper circulation.
CAUTION:
Allergic exanthema (s ymptom atic eruption) in the area of the cuff m ay result,
including the formation of urticaria (allergic reaction including raised edematous
patches of skin or mucous m embranes and intense itching) caused by the
fabric material of the cuff.
CAUTION:
Petechia (a minute reddish or purplish spot containing blood that appears in the
skin) formation or Rumple-Leede phenomenon (multiple Petechia) on the
forearm following the application of the cuff, which m ay lead to Idiopathic
thrombocytopenia (spontaneous persistent decrease in the num ber of platelets
associated with hemorrhagic conditions) or phlebitis (inflammation of a vein)
may be observed.
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Introduction to the Tempus IC
3.1
Product Description and List of Features
Colour iAssist help processes are provided to assist the user in every stage of use.
Everything that is displayed on the Te mpus IC screen is sim ultaneously seen at the response
Centre, enabling the medical expert to fully interact with the operator. The medical expert can,
in fact, fully control Te mpus IC if required, giving added comfort to the operator and patient at
the rem ote location.
Tempus IC in Use
The Te mpus IC sends all of its measurements and displays via the telephone connection to
the response centre, where the displays are duplicated. The m edical expert at the Response
Centre is also able to annotate (with words, sym bols and markings) and send back the still
video picture to better illustrate the verbal instructions being given to the operator at the rem ote
location. If necessary, the expert can take control of most functions of the Te mpus IC, giving
added com fort to both the user and patient.
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Introduction to the Tempus IC
4.1
Tempus IC Device
The Te mpus IC is a m ulti-parameter vital signs m onitor which connects to a dedicated
Response Centre. Connection is achieved using different communications technologies, refer
to the Modes Menu on your Tempus for details of what communications systems it can be used
with.
A physician may use the Te mpus IC as a stand-alone diagnostic device (without it being
connected to the Response Centre).
The Te mpus IC provides the following inform ation about the patient from its sensors:

Pulse rate

Oxygen saturation (SpO 2 )

Blood pressure

12 lead Electrocardiograph (ECG)

End tidal CO 2 (ETCO2)

Respiration rate
These readings are transmitted via a communications link to a computer at a response centre
which enables the physician to see all the vital signs data.
Additionally, the Te mpus IC includes a colour video cam era which is capable of sending colour
still images to the response centre.
The following sections describe how each of the sensors, the camera and communications
systems work.
The Te mpus IC consists of a enclosure which is overmoulded with rubber to make it resistant
to shock. The enclosure also includes a rear clip which provides storage for the SpO 2 sensor,
the NIBP cuff and comm unications cable.
Touchscreen
Membrane
buttons
Jog
Wheel
Deployable
Feet
The Tempus IC
4.1.1
Battery
Tempus IC Front
The front of the Tempus IC has a large screen which is fitted with a touch-screen.
The front panel houses two keypads which are graphically labelled with their function. Also
present is a jog wheel which can be used to scroll through instructions.
4.1.2
Tempus IC Base
The base of the Te mpus IC houses the battery.
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User/Operator Manual
Tempus IC Rear
TM
®
The rear of the Te mpus IC houses the RapidPak clip (discussed above) and the Bluetooth
Headset. This item is docked onto a connector which enables the VSM to top the charge of the
headset up automatically on a regular basis, thus ensuring the headset is always ready to use.
Also on the rear is the aperture for the cam era and backlight, this aperture is labelled for
aesthetic purposes. The clip carries a general product label for regulatory purposes and also
two labels which help guide the user to repack the SpO2 sensor and the comms cable. The
top of the clip carries a product-specific brand also.
4.1.4
Tempus IC Sides
The left side of the device contains four connectors for:

ECG - blue,

NIBP – white latching connector;

SpO2 – orange;

ETCO2. – yellow.
Normally the NIBP and SpO 2 connectors will have their mating half attached at all times.
Left Side of the Tempus
The right side of the VSM houses the non-medical connections. These comprise:

USB – this is reserved ONLY for non-mains powered USB peripherals (such as mouse
and keyboards) approved for use with the Tempus IC by RDT. It is also for use with
the USB - Serial Cable (part num ber 01-1022) for customers using Iridium or other
serial satcoms systems.
WARNING:
The USB connection must only be connected to non-mains powered
peripherals (such as a mouse or keyboard) or to interface accessories provided
by RDT (such as the USB-Serial Cable pn 01-1022). Any connections made to
the USB port must be to medical or IT peripherals or communications systems
which comply with the applicable IEC safety standard (i.e. IEC60601-1 or
IEC60950). Any connection arrangem ents must be made in a manner
compliant with IEC60601-1-1.

RJ-45 Ethernet – use only the Ethernet Cable pn 01-1021 or Dual Modem Cable pn 011014 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
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The RJ-45 connector provides the Ethernet connection (the Ethernet cable is normally fitted).
Communications Connection Panel
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User/Operator Manual
Using the Tempus IC
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
Controlling the Tempus IC
The Te mpus IC is graphically rich and provides audio feedback from the device in the form of
beeps, tones and error m essages. The feedback differs depending on if the user presses
active or inactive parts of the touchscreen.
At any time, if the user is unsure of what to do they m ay press either of the following two
buttons on the front of the device:
the Help button - this will take you to a set of m enus.
the Home button - this returns the unit to the results screen.
5.1.1.1
Layout of Instructions on the Tempus IC
The Te mpus IC provides the user with com plete instructions on how to use it. Every step is
detailed in pictures with accompanying text instructions. There are instruction processes for
everything the user will need to do with the device:

from obtaining a voice and data connection to the GMS,

through applying all the medical devices;

and then cleaning, repacking and replenishing the device.
The help screen shows a typical screen from the Te mpus IC. It shows that there are three
distinct areas on the screen that give different types of inform ation.
1. Status Bar
This shows if the voice and data links are connected, if ECGs or
pictures are being transmitted and what the time is when recorded.
2. Process Instructions This area contains the graphical pictures and text instructions that
show you how to use the device. This takes the user through each
activity one or two steps at a tim e.
3. Touch Screen Buttons In this exam ple there are two buttons at the bottom of the
touchscreen. In all cases the user will press the button on the bottom
right of the screen to progress onto the next step in the process.
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Status bar
Help process
graphics and
instruction
Touch screen
buttons
Example of the Te mpus IC Screen Layout
5.1.1.2
Progressing through Help Processes
As m entioned above, the Tempus IC breaks all processes down into small steps. These steps
are shown on the screen in one or two at a tim e.
The user can see how many steps there are in any process by looking at the Process Ribbon
near the top of the screen.
Process
Ribbon
Example of the Process Ribbon
In the example shown above, the screen shows that the process has 6 steps and that the
device is showing steps 1-2.
The user follows the instructions given on the screen, ensuring that they review both the im age
and the text. Once they have completed both steps they proceed onto the next steps by
pressing the Ne xt touchscreen button.
Pressing this will bring up the instructions for the next 1 or 2 steps in the process. Similarly
they can go back to earlier steps by pressing the Previous touchscreen button.
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Process
Ribbon
updated
Previous
button to
return to
last step
Example of the Middle Steps of a Process
Next button to
progress to
next step
At the end of a process, the Next touchscreen button changes to show an icon that relates to starting the
action that the process has prepared for. So at the end of the process that has been shown in this exam ple,
the user would start the voice link connection.
Process
Ribbon
complete
Example of the End of a Process
5.1.1.3
Icon
shows end
of process
Getting Help
As m entioned 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 m ultiple sequential m enus covering different
aspects of using the Te mpus IC. For exam ple, when the first Help Menu is on the screen, the
next m enu (Cleaning and Repacking Menu) can be accessed by pressing the Ne xt
touchscreen button.
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From the Help
Menu, press
the Next
button to bring
up the
Cleaning and
Repacking
Menu
Example of the Help Menu
Example of the Cleaning and Repacking Menu
The user can m ove backwards and forwards through the Menus by pressing the Next and
Previous touchscreen buttons.
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5.2
User/Operator Manual
Explanation of the Tempus IC Screen
Tempus IC screen normally divides into two sections:

Connection status and tim e of day at the top

Instrument readings in the m iddle
Status
bar
Instrument
Readings
Example of the Tempus IC Screen Display
5.2.1
Status Bar – Clock (Time Stamp)
The time of day is shown in Greenwich Mean Time (GMT), which is also known as Universal
Time Co-ordinate (UTC). Te mpus IC has an internal clock which is automatically synchronised
to an accurate time reference at the Response Centre as soon as a call is m ade.
Example of the Tempus IC Screen Display
5.2.2
Time
in
GMT
Status Bar – Bluetooth® Indicator
The Bluetooth® indicator identifies the number of Bluetooth
the device, i.e. 1 sensor at this tim e.
NOTE:
®
peripherals that are connected to
It does not identify the specific peripheral connected to the Tempus IC.
Bluetooth
Indicator
Bluetooth® Peripheral Indicator
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5.2.3
User/Operator Manual
Status Bar - WiFi Indicator
WiFi
Indicator
WiFi Status Indicator
This indicator is displayed when the Tempus IC is connected to the Response Centre using
WiFi comm unications technology.
5.2.4
Status Bar – GSM/GPRS Indicator
GSM /
GPRS
indicator
GSM Status Indicator
This indicator is displayed when the Tempus IC is connected to the Response Centre using
GSM or GPRS communications technology.

Note that the display shows 5 coloured bars under the GSM sym bol.

A single red bar m eans that a GSM or GPRS network is present but the signal strength
is not sufficient to support a data connection

Two orange bars means that a data connection can be made but that the perform ance
may be im paired.

Three to five green bars means that the signal strength is sufficient for a data
connection.
NOTE:
The Te mpus IC uses GSM and GPRS networks to m ake a data connection. This
requires the network signal strength to be better than is required for a conventional GSM
handset (which makes a voice only connection). Users should note that the signal strength
readouts from the Tempus are not comparable to those of third-party handsets as the scale,
setting, sensitivity and networks between the two devices may be different.
5.2.5
Instrument Readings
This section of the screen shows the results (if any) from the five different medical devices
(ECGs are displayed separately). Each of the three areas shows more than one piece of
information i.e. data taken, time taken and type of units are displayed. Descriptions of the
instrument readings are contained in the sections of this m anual which describe each
instrument.
When iAssist help processes are displayed, they take up the space norm ally occupied by the
instrument readings and the status indicators.
All of the m easurem ents except blood pressure and ECG are continuous, that is they are taken
automatically without operator intervention. Data from these m easurem ents is sent
automatically to the Response Centre in real-time (if the data line is active), otherwise the
measurements are mem orised and sent when the data line is next active.

ECG measurements produce a lot of data which takes a few minutes to transmit to the
Response Centre. ECG m easurem ents can be initiated manually by the operator or
remotely by the Response Centre.
All data which is generated by the Tempus IC is autom atically tim e-stam ped.
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5.2.6
User/Operator Manual
Instrument Status Indicators
The Instrum ent Status indicators show what each instrument is doing. The status can be one
of the following:
Measuring
The instrument is currently taking a reading
Idle
The instrument is currently idle
On timer
The instrument is m aking tim ed m easurem ents (e.g. blood pressure) and
will make another m easurem ent in due course.
Disabled
The instrument is disabled, possibly due to a fault (see Troubleshooting in
section 10.3)
Additionally, further inform ative Status messages m ay 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 norm ally occupied by the
instrument readings and the status indicators.
5.3
Device Sensors
All of the m easurem ents m ade by the Tempus IC are transmitted in real time except the ECG
(and digital pictures) which is first recorded and then transmitted to the Response Centre.
ECG data and digital pictures take the following amount of time to send to the Response
Centre:

12 lead ECG – 2-3 minutes*

Digital picture – up to 1 minute
* These tim es are for guidance only and are based on the worst case communications system
(off-aircraft satellite link running at 2.4Kbaud V22BIS) and m ay vary depending on the quality of
the connection. Higher bandwidth connections (e.g. using Inmars at Swift 64, Fleet 77, B-GAN
or Swift Broadband) will provide lower transmission times.
5.3.1
Pulse Rate and Oxygen Saturation (SpO2)
Pulse rate and oxygen saturation are detected by a reusable finger probe. This probe contains
a visible (red) and invisible (infrared) light source and matching sensors. The sources and
sensors are arranged so that the lights shine through the patient's finger when it is inserted into
the clip. An am ount of light also reaches the sensor via scattering within the skin.
It is also im portant that the sensor is not used on the same arm as the blood pressure cuff,
because false readings may occur when the cuff is inflated. Readings will not be obtainable
from patient’s with nail varnish or polish, consequently the Te mpus IC is stocked with nail
varnish removing wipes in the bag. In the event that these are needed, the operator should
follow the instructions on the wipe.
5.3.2
Blood Pressure
Tempus IC uses non-invasive techniques to measure the patient's blood pressure. A pum p
within Tempus IC inflates the reusable blood pressure cuff around the patient's arm.
Circulating blood within the arm causes slight changes (oscillations) in the cuff pressure, which
can be detected and measured. As the inflation pressure changes, the systolic, diastolic and
mean arterial pressure can be measured.
This m ethod of blood pressure m easurem ent provides accurate readings provided that the
correct size of cuff is us ed and the specified operating precautions are observed.
5.3.3
Electrocardiograph (ECG)
Electrical currents influenced by the cardiac impulse flow through the body tissue around the
heart. Te mpus IC uses 10 electrodes (in a pre-s et reusable apron configuration) placed mainly
on opposite sides of the heart to detect these currents.
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The position of the electrodes is critical and so Te mpus IC uses a specially m oulded electrode
apron which has nine of the electrodes positioned in the correct places to pick up the signals.
The tenth electrode is positioned separately on the patient's leg. The electrode apron is made
of elastic m aterial so that as it stretches to accommodate different sizes of patient, the positions
of the electrodes vary to maintain correct placem ent.
5.3.4
End Tidal CO2 (ETCO2) and Respiration Rate
The Capnom eter CO 2 module is used to m onitor continuous carbon dioxide and report the End
Tidal carbon dioxide (ETCO 2), inspired CO 2 and respiratory rate values of non-intubated adult
patients. The Capnometer CO 2 module is used for the continuous m easurem ent of CO 2 (carbon
dioxide) and respiratory rate.
The capnometer uses a Sidestream sampling system with a low sampling rate that is used to
measure the CO 2. A tube inserted into the patient's nostrils detects sam ples of their exhaled
breath. The tube is connected to a pump within the module which draws the sample through a
measuring chamber.
In the capnometer, infrared light is generated by the sensor and beam ed through the sam ple
cell to a detector on the opposite side. CO 2 from the patient that is aspirated into the sam ple
cell absorbs some of this infrared energy. The monitor determines CO 2 concentration in the
breathing gases by measuring the amount of light absorbed by these gases. ETCO 2 is
displayed as a partial pressure in millim etres of mercury (mmHg). Respiration rate is calculated
by measuring the tim e interval between detected breaths.
5.4
Digital Camera
A miniature digital camera is mounted in the unit. Images from this cam era can be sent to the
Response Centre to provide the physician with a view of what is happening to the patient.
Moving pictures from the cam era are captured by the Tempus IC and displayed on the screen.
Still images require as much as 1 m inute to transmit on a low-speed (2k5baud) link. Links with
greater bandwidth will transmit the picture in less tim e.
5.5
Voice and Data Communications
The Tempus IC can connect over either modem connections, over serial channels and over
wired or wireless (WiFi) Ethernet networks. The Tem pus IC will be pre-c onfigured by RDT to
operate over the user’s network.
NOTE:
RDT recommends that users perform a test connection to the response centre
every month in order to verify that their comm unications rem ain open for the
Tempus to use.
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6.1.1
User/Operator Manual
Setting Up
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
Unpacking the Tempus IC
The Tempus IC is supplied from the factory in protective outer packaging. No special
precautions are required when unpacking the Tempus IC. You do not need to keep the
packaging. RDT recommends that the equipment is inspected and tested on receipt to confirm
that the unit has not been dam aged and that all expected items and accessories have been
received and are in working order. New batteries should be charged up for at least 4 hours on
receipt.
6.2
Tempus IC Bag
The Te mpus IC bag is a custom design part made from moulded rubber. It is provided with a
shoulder strap and carry handle.
The bag provides a m ain storage area for the Tempus IC (including windows to check the
battery status and turn the device on externally to avoid the user opening the bag to do this), a
storage area for the ECG harness, a range of pockets for consum ables in the lid and a range of
pockets for accessories and consum ables on the rear.
Each bag contains the following items:

1 Te mpus IC fully packed including battery, Adult BP cuff and hose, SpO2 probe and
Ethernet cable

1 Vial of Glucom eter Strips*

1 ECG spray

5 AlcoWipes

5 Nail varnish wipes

1 pack of 10 thermom eter covers with application tool*

1 pack of 3 glucometer lancets*

1 Bluetrek Thermom eter*

1 Bluetrek Glucom eter*

1 pack of Vinyl Gloves (pair)

2 Extension Reels**

1 Wired Headset

1 Consum ables Replenishment kit

1 Glucom eter Replenishm ent kit

1 Lo-Flo Capnometer

2 Capnom eter 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***
®
®
®
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* Note: that Tempus IC will initially be shipped with Glucometer and Thermometers that are read y for use but disabled
in software. The y will be enabled for use by a future software upgrade. The thermometer and glucometer will not be
operable until the software upgrade has been performed.
** Note: non-commercial aviation users who do not use Iridium satcoms systems are provided with a single extension
reel.
*** Note: not supplied to commercial aviation customers
Refer to section 11.1 for details of how to obtain further supplies of these disposable items.
In addition, the Te mpus IC is supplied with the following accessories which are not packaged
in the Bag:

1 Mains Power Supply

1 Mains Cable Pack

1 Battery Charger

1 spare battery

1 Accessory Pouch (note this is only supplied to commercial aviation customers)

1 User manual (CD-ROM)
Window to access
the ON/OFF
button
Window to access
the Battery charge
indicator
The Te mpus IC Bag
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Consuma bles in colourcoded pockets
Tempus IC
location
ECG Harness
Accessories and
Consuma bles in colourcoded pockets
The Bag open with the Tem pus IC removed
6.3
Switching On
6.3.1
Immediately after Switching On
Note
The Te mpus IC takes up to one minute to become ready for operation after switching on. It is
recommended that you switch on Te mpus IC at the same time as you remove it from its
storage location rather than when you arrive at the patient.
To switch on the Te mpus IC, press and hold the
button on the front panel for 3 seconds.
Release the button when the lam p at the top left corner of the button starts flashing green. The
device is ready for use when the LED shines green constantly. If no buttons are pressed within 8
minutes, the unit will switch off automatically to save battery power.
CAUTION: Do not press any of the control buttons until the first iAssist help process artwork
is displayed on the screen.
After switching on, the Te mpus IC goes through a pre-defined set of iAssist help processes.
These are:

Making the data connection

Using the headset and m aking a voice connection

Transmitting a digital picture

Blood Pressure and Pulse Oximeter
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You can press
to jum p straight to the results screen, or any other button to get help for
that instrument e.g. pressing
will bring up the first Help Menu or pressing
the help m enu for the capnometer.
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Establishing Communication with the
Response Centre
The first step for using the Tem pus 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 Tem pus IC to the Response Centre.

Fit the Headset comfortably in your ear.
It is possible for a physician to use Te mpus IC as a standalone diagnostic tool without
connecting to the Response Centre. Under these circumstances, just press the appropriate
measurement function button to access that function. It is still possible to be connected to the
Response Centre at any tim e by pressing the Connect button.
The Te mpus IC can also be left running with the data link connected but the voice link
disconnected i.e. if the Response Centre physician wishes to continue m onitoring the patient
for a long duration but without keeping the voicelink open with Te mpus IC User. In this case
the voicelink can be rec onnected at any time by pressing the Connect button.
7.1
Making the Phone Connection
Press the
button on the touch screen to get instructions on how to setup and connect the data
connection. Note that these instructions will appear by default every tim e you turn the unit on.
When you have followed the instructions and have pressed the
screen will appear.
button, the Wireless Headset
Dialling the Data Connection
If the Response Centre cannot be contacted, this could be due to errors in the way that the
connection has been attem pted (s ee section 10.3 of this m anual for Troubleshooting
information). Help will be given in the form of iAssist help process, follow the instructions given
and wait for a few minutes before trying again.
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If your Tempus has been configured for autom atic redialling, then it will attem pt to connect to
the Response Centre if the first call fails. The system will indicate the redial process by
displaying a number over the Data Link status indicator. The system will attem pt a num ber of
redials (typically 3), and will display the corresponding number over the Data Link status
indicator bar.
7.2
Fitting the Headset and Making the Voice
Connection
After dialling the data link the device will by default bring up instructions to fit the wireless
headset. Follow the onscreen instructions and at the end of the process press the
on screen to dial the voice link.
button
It is important to have attached the headset before dialling as the voice connection to the
response centre can be m ade quickly.
Remem ber that often the voice connection will be made over a satellite link so you m ay
experience background noise or drop-outs. RDT recomm ends that you adopt a process of only
one pers on speaking on the line at a tim e and then handing over to the other speaker by saying
“over” or similar.
Example of the Wireless Headset IAssist help process
NOTE:
If you do not wish to use the wireless headset, a wired headset is provided in
the bag as an alternative. To switch to the wired headset press the
button
on the touch screen as identified in the above screen and follow the on-screen
instructions showing you how to use it.
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Example of the Wired Headset IAssist help process
NOTE:
7.2.1
To switch to the Wireless Headset press the
as identified in the above screen.
button on the touch screen
Using the Wireless Headset
®
The Tempus IC uses the G3 headset provided by Bluetrek . Note that the headset will be
supplied in a charged state and its charge level is automatically m aintained so long as it is
regularly docked on the charging pin on the back of the device.
®
It should also be noted that the G3 is a Bluetrek wireless device. It is supplied “paired” with
the Tempus IC. You cannot use different wireless headsets with the Tem pus IC and RDT
recommends that you do not attem pt to use the G3 supplied with the Tem pus IC with any other
wireless devices (including other Tem pus ICs or other communications devices such as m obile
phones).
Each G3 is “paired” to only the Tem pus IC to which it is attached on delivery. While attaching
the G3 to other Tempus IC units will not cause any damage, users should avoid this practise as
it may cause confusion and ultimately prevent voice calls from being made when needed.
If the G3 is lost or is damaged, contact RDT for a replacement.
7.2.1.1
Introduction
The headset has 3 buttons:

TALK

VOL +

VOL –
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7.2.1.1.1
User/Operator Manual
Wearing the Headset
To put the headset on, follow the instructions given on screen. Note that the ear clamp is made
from soft m aterial. It can be flexed and shaped to fit your ear. You should ensure the speaker
is properly inserted into your ear.
7.2.1.1.2
Controlling the Wireless Headset
To turn the headset on, rem ove it from its dock and press and hold the talk button for 2-3
seconds until the blue indicator light is on. A beep (2 tones) can be heard in the speaker.
Release the talk button as soon as the headset is on.
NOTE:
If you keep the talk button held down after the headset is on, you can put the
headset into pairing mode. This is not desirable as it could potentially cause
the headset to cease being paired with the Tempus IC and thus prevent it from
operating with the device. Airing mode can be recognised by the indicator light
slowly flashing red and then blue. If the headset is inadvertently put into
pairing mode it should be placed back onto the docking pin on the Tem pus to
turn the headset off; the voice call should be disconnected and re-initiated.
You can check if your headset is on by pressing the talk button once. If the indicator light
flashes blue then this means the unit is on.
You do not need to switch the headset off, this is achieved by docking the headset back onto
the Tempus IC. If you do wish to turn the headset off, press and hold the talk button for 5
seconds until the indicator light first flashes blue and then goes red.
NOTE:
If you turn the headset off during a call, you will not be able to receive the call
again with the headset i.e. if you turn the headset back on you will not hear the
call again. If the headset is turned off during a call, disconnect the call using
the Tempus IC and then re-initiate the connection again following the onscreen 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 m uted. To
release muting, quickly press the “vol+” button on the headset. RDT does not
recommend that you use the muting function as this could cause confusion
during a call.
If you need to adjust the volume of the headset of the wireless headset (the wired headset has
no volume controls) after you have connected the voicelink, you can get instructions on how to
adjust the volum e by pressing the
button. This is shown the first time you
go into the camera iAssist process and the first tim e you go into the blood pressure and pulse
oximetry process after switching on. You can also access the sam e instructions by pressing
the Headset button on the main help menu after you have connected the voicelink.
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Headset Help Button
Pressing the Headset Help button will bring up an iAssist process. This contains four different
steps, each of which gives instructions on addressing a different type of issue e.g. you can’t
hear the response centre, they can’t hear you etc.
iAssist Process for Adjusting the Wireless Headset’s Volum e
7.2.1.1.3
Charging
RDT do not supply a separate charger for the headset. The charger is built into the Tem pus IC.
You must follow the repacking instructions provided by the Tempus IC on screen. These will
instruct you to clean the headset after use and to replace it on its docking pin before shutting
down.
If you do not replace the headset then the Tempus will show an error advising that the headset
should be refitted.
Placing the headset onto the docking pin enables the Tempus IC to recharge it. The Tempus
IC recharges the headset for up to 4 hours 30 m inutes (apx) every time the headset is
replaced. The charging cycle will continue regardless if the Tempus IC is switched on or off.
Charging is started as soon as the headset is fitted to the docking pin. The indicator light on
the headset will light red for the duration of the charging process although it m ay switch off
intermittently for 8 second periods (this is part of the charging process). The indicator light will
go off when charging is complete – which could be less than the 4 hour 30 minute m aximum
cycle tim e depending on how depleted the headset battery is.
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In addition, the Tem pus IC will top up the charge of the headset approxim ately 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 em pty (less
than 5% charge).
7.2.1.1.4
Caution:
Do not attem pt to charge the headset using any other charging device. This
will automatically suspend the warranty and could be dangerous.
Note:
The headset has a life of up to 500 charge cycles.
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 has
no protection against ingress of solids or liquids.

Do not expose your headset to extrem e temperatures. The tem perature range of the
headset is 0-40C.

Do not try to disassem bly your headset. Service and Maintenance can only be
perform ed by RDT.

Do not let children play with the headset since it contains sm all parts that could
becom e detached and create a choking hazard.
CAUTION:
Danger of explosion if battery is incorrectly replaced. Do not attempt to repair
or replace the battery. If the battery is worn out a new headset is required from
RDT. Dispose of the headset in accordance with local regulations. Do not
dispose as household waste.
®
The user m anual for the Bluetrek G3 headset is supplied on the same CD-ROM as this
®
manual. Details from that manual have been reproduced in this section courtesy of Bluetrek .
7.3
Connection Status Indicators
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
The connection status indicators show whether the Te mpus IC is connected to the Response
Centre. There are separate indicators for the voice link and the data link.
The following sym bols 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.
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7.3.1
User/Operator Manual
Dialling Order and Indicators When Dialling
Once a voice or data link has been initiated, the “No call in progress” indicator will change to a
“Call in progress” indicator which will start to flash. The voice and data link indicators will flash
independently until each link has been connected.
While waiting for the voice link to connect, the Te mpus IC can be used to take measurements
of the patient e.g. blood pressure, pulse oximetry and a video picture, which will then be
available to the response centre as soon as the connections have been com pleted.
7.3.1.1
Data Dialling
Once dialling has been initiated, text will appear giving a countdown to when the data link is
expected to connect. This is accom panied by a blue progress bar which grows as the tim e to
connection gets closer.
Once the data link has been established the text indicator will display “Data Connected” and
the “Call in progress” indicator which will stop flashing.
7.3.1.2
Voice Dialling
The voice link will start to dial as soon as the data link is connected. If the data link is taking
longer to connect than usual (as a result of difficulties with the communications channel) then
the voice link will dial within a preset time (typically 3 m inutes 40 seconds).
In addition, a countdown will flash behind the “Voice Link?” status indicator to show how long it
can be before the voice line will start to dial, the voice link will typically dial before the
countdown is completed.
Once the voice link has been established the text indicator will display “Data Connected” and
the “Call in progress” indicator which will stop flashing.
NOTE:
7.3.1.3
If your Te mpus IC has a built in Cell Phone (GSM) phone built into it, then it
will need to log onto the network at the beginning of each call. This is shown
by similar text and a separate progress bar for logging on.
Automatic Redialling
If the Tempus IC is configured to redial the voice or data links automatically then it will indicate
that a redial is taking place by displaying a num ber behind the “Call in progress” indicator.
7.3.1.4
Indicators Once Connections Have Been Established
Once the voice and data links have been connected, their status indicators will stop flashing. In
addition, once the data link has been established the progress bar will disappear and the
following text will be displayed.
7.3.1.5
File Transfer Status Indicator
When data files (either an ECG or a still digital picture) are being transmitted, the progress bar
shows how far the transmission has progressed.
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7.4
User/Operator Manual
Communications Modes
Tempus IC can connect to the Response Centre using different connection a num ber of wired
and wireless communications interfaces e.g. Ethernet or WiFi.
Connecting over wired interfaces such as Ethernet requires connecting the Tempus using a
cable; connecting over wireless interfaces such as WiFi require no physical connection to be
made.
To switch between thes e types of connection, the Te mpus IC is pre-set to connect using
different communication “Modes”. Each Mode is supported by a full set of graphical connection
iAssist help process that provide the User with instructions specific to connecting using that
technology.
The Te mpus IC shows what Mode it is in with a banner at the top of the Connection IAssist
help process.
The Te mpus IC will stay in this Mode until it has been set to another Mode (even if it has been
turned off and on again).
7.4.1
Changing Modes
You can change the Mode that the Te mpus IC is set to by pressing
from the Help Menu
IAssist help process. This will bring up the Comm unications Modes Menu.
NOTE:
Follow the instructions provided on the Menu shows what Modes are available to use
(See Section 7.4.3).
7.4.2
Using Available Modes
The Modes that are available on each Te mpus IC are dependent on the requirements of each
User. Refer to the Modes Menu on your Tem pus IC for specific details of each Mode that is
available.
Remem ber that each Mode may have a different set of instructions for connecting, fault finding
and repacking. Consequently it is vital that you remem ber to read and follow what each iAssist
help process says at all tim es.
It is also im portant to rem ember that if one Mode cannot be used then another m ay be usable
in its place e.g. if GSM coverage is not available then a landline connection may be useable
instead.
7.4.3
Changing the Connection Mode
To change m ode, bring up the help m enu and then follow the instructions below:
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1. Press the
touchscreen
here
The Modes Menu Button on the Help Menu
2. Then make
the relevant
selection by
pressing on one
of the buttons
shown here –
CHECK the title
of the mode is
what you want.
Example of the Modes Menu
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If you wish to
exit the Modes
Menu press
here.
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3. You can
confirm that the
correct selection
has been made
by checking the
title.
Example of the New Mode Title
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Taking Medical Readings
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
The Te mpus IC is intended for use on one patient per incident. It m ust not be used on m ore
than one patient because the Te mpus IC has no way of associating a measurement with a
particular patient.
WARNING
It is essential to switch off the Tempus IC in between different patients to avoid
confusion between different patient records.
8.1
Blood Pressure and Pulse Oximeter
To activate the Blood Pressure & Pulse Oximeter function, press the
button on the device. The
first step in the Blood Pressure & Pulse Oximeter help process will appear.
Follow the instructions provided on the iAssist help process to activate Blood Pressure & Pulse
Oxim eter.
Select the correct size blood pressure cuff from the storage compartm ent (the normal size adult cuff
is highlighted on the Blood Pressure And Pulse Oximeter Help Screen shown on the device).
The cuff must fit comfortably on the upper arm. To connect and connect the tube to a cuff, insert
using a twisting motion
Example of the Blood Pressure And Pulse Oxim eter Help Screen
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WARNINGS
T he Tempus IC is not for use on neonates (young babies).
The Tempus IC is not intended for long term patient monitoring. There are no audible or
visible alarms.
Reposition the oximeter probe at least once every 1hour to allow the patient's skin to
respire.
The SpO2 sensor should snugly fit the finger without straining it and if not alternative
fingers should be tried.
The Tempus IC will not operate effectively on patients who are experiencing convulsions
or tre mors.
Prolonged or repetitive use of the blood pressure cuff may harm skin integrity and
circulatory status. Observe the limb concerned to check that circulation is not impaired.
CAUTION
®
OneTime nail polish re mover is flammable. Keep away from heat and flame. Use
adequate ventilation. Exposed pad should be placed on glass or tile surface only. FOR
EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN.
Notes
Dyes introduced into the bloodstream , including methylene blue, indocyanine green, indigo
carmine and fluorescein may cause an inability to determine accurate SpO 2 readings.
Any condition that restricts blood flow, such as use of a blood pressure cuff (other than the
Tempus IC cuff used in accordance with the instructions herein) may cause an inability to
determine accurate pulse and SpO 2 readings.
Compression or restriction of the blood pressure hose or cuff, or induced movem ent or vibration
may prevent the monitor from taking a reading.
SpO2 measurements may be adversely affected in the presence of high ambient light levels. If
necessary, shield the sensor area (e.g. with a towel).
Remove fingernail polish or false fingernails using the wipe provided before applying SpO 2
sensors. Fingernail polish or false fingernails may cause inaccurate SpO 2 readings.
Performance and safety test data are available on request from the address in section 1.1.
Significant levels of dysfunctional haem oglobins, such as carboxyhaemoglobin or
methemoglobin will affect the accuracy of the SpO 2 measurement.
The graphical displays of pulse rate, SpO 2 and pulse strength are not proportional to the pulse
volum e.
The SpO2 sensor must be on the opposite arm to the blood pressure cuff. The arm of the
patient must be kept still and either be horizontal to the shoulder (if the patient is laying down)
or below the shoulder (if the patient is sitting upright). If the finger selected does not give good
results, this could be due to poor perfusion of blood. Ensure that the finger is inserted all way
into the clip, or try taking a reading on another finger.
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IMPORTANT
You must use the right size of blood pressure cuff to suit the patient,
and you m ust tell the Tem pus IC if you are using the Large cuff or Child cuff.
The cuffs are m arked as follows:
Normal adult (23 – 33 CM). Cuff is coloured BLUE.
Large adult (41 – 40 CM). Cuff is coloured DARK RED.
Child or small adult (12 – 18 CM). Cuff is coloured GREEN.
8.1.1
Understanding the Pulse Oximeter Results
The Pulse Oximeter display has four data elements. Measurem ents are made continuously
and updated in real time. Measurem ents are sent in real tim e to the Response Centre provided
that the data link is active.
The Pulse section contains a bar graph and digital display of the patient's pulse rate, in beats
per minute (Bpm).

Note that extreme pulse rates above 175 Bpm or below 25 Bpm are outside the range of
the bar graph display but will be shown accurately on the digital display.
The SpO2 section gives the oxygen saturation of the blood, and displays the result in bar graph
and digital form.

Note that extreme blood oxygen levels below 50% are outside the range of the bar graph
display but will be shown on the digital display (readings below 40% are not shown).
The Signal Strength bar graph shows the how well the pulse sensor is detecting the pulse. The
amplitude of the indication indicates the quality of detection. If the indication on the Signal
Strength meter is low, or becomes low, then the finger sensor should be repositioned. Similarly
the Perfusion Index gives a num erical indication of the level of arterial pulsatile blood at the
sensor site.
8.1.2
Understanding the Blood Pressure Results
The Blood Pressure display has three elements plus a status indicator. The results comprise
Systolic and Diastolic readings in mmHg and a timestamp in GMT. Once the BP is active
(either inflating or deflating or on timer), the
button will be shown next to the Cuff Status
icon. Pressing this button at any time will stop the blood pressure m onitor and cause the cuff to
deflate immediately.
The measurements are normally m ade every five minutes via an automatic timer. Note that
when the unit is in tim er m ode, the Cuff Status icon will change state. The possible states of
the blood pressure monitor are:

Blood pressure m onitor is idle;

Cuff is inflating;

Cuff is deflating;

Cuff is on tim er;

Cuff is on tim er;
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
Cuff is on tim er.
Measurements are sent to the Response Centre every time they are made, provided that the
data link is active.
8.1.3
Blood Pressure Monitor Error iAssist Help Process
The Tempus IC will autom atically display iAssist help process in the event that it encounters
problems in taking a blood pressure m easurem ent. The problems that it can encounter may
often have a fairly simple solution, consequently, the iAssist help process attempt to guide the
Operator through some basic checks that can be made.
The conditions that could occur are:

The cuff or hose leaking;

Overpressure – caused by blockage or com pression on the cuff;

Weak signal – caused by a poor connection to the patient, a blockage or similar;

Timeout – the Tem pus IC could be detecting noise from the cuff which prevents a valid
reading from being made, this could be caused by m ovement on the cuff or hose,
vibration, patient activity etc.
If the Tempus IC experiences one of these types of errors, it will provide on-screen instructions
on how to check for and clear the problem. It should be understood that it can be normal to
experience these types of errors when taking readings if the usage instructions have not been
followed carefully.
8.2
Electrocardiograph (ECG)
To activate the ECG function, press
button on the device
The first step in the ECG help process will appear.
Follow the instructions provided on the iAssist help process to activate ECG.
WARNINGS
The Tempus IC should not be used on patients undergoing defibrillation. The Tempus
IC is protected against defibrillator discharge but rate meters and displays may be
temporarily affected during defibrillator discharge but will rapidly recover.
The Tempus IC will not operate effectively on patients who are experiencing convulsions
or tre mors.
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Example of the ECG Help Screen
CAUTIONS
The electrodes of the ECG apron must be applied carefully.
Care must be taken to ensure that the electrodes do not contact live (electrical) parts or
earthed metal parts of local syste ms or structures.
The ECG spray is not to be used on broken or irritated skin
Note
Whilst the ECG harness fits many patients, one size cannot fit all patients. Consequently, the
ECG data collected may not be of diagnostic quality for some patients.
The leads and cables of the ECG should be checked for fraying, tears, knots or other signs of
dam age before and after use.
The ECG spray is not a disinfectant. If the ECG contact spray goes into a person’s eyes, it m ay
be washed out using clean water.
The ECG spray bottle is marked with a label reading “USE BY:” and then giving a date. All
bottles of fluid m ust be discarded once this date has been reached.
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Once the iAssist process has been completed the Tempus will display the ECG.
The ECG Monitoring Screen
The Tempus IC is now m onitoring the patient's ECG, but is not recording the information. The
traces m ove across the screen from left to right, erasing and replacing old readings as the
monitoring progresses. It takes 3-4 seconds for the trace to cross the screen. You should wait
at least 30 seconds before recording the ECG. While the ECG is on the patient should sit still,
relax and not talk as any of these activities can disrupt the ECG.
The displayed waveforms may be partially or totally disrupted if,

The patient is moving or talking;

The harness is not connected properly;

The electrodes have not been sprayed with the contact solution or the solution has dried
off;

The harness is not positioned correctly.
The bottom of the screen shows the current status of the ECG settings.
ECG Filter 50Hz 60Hz. This should either be set to 50Hz or 60Hz. ECG systems can pick up
interference from mains electricity supplies. This interference appears on the screen as regular
interference patterns. The filter setting is shown in the bottom left corner of the ECG. It will
either show 50Hz or 60Hz as lit, pressing on this area of the touchscreen will change the
setting.
8.2.1
Monitoring an ECG
To record an ECG, press ‘Start Recording’ on the touch screen.
Recording an ECG takes ten seconds. It is essential that the patient is relaxed and does not
talk or m ove while an ECG is recorded. If the patient is moving then the muscle movement can
produce small electrical signals (known as “artefact”) into the ECG. An ECG containing artefact
(additional signals appearing on the ECG which are generated by muscle movement and not
by the heart) may not be clear enough for a medical professional to make a diagnosis so it is
important that the patient rem ains com pletely still during the recording.
Hz m eans Hertz, or cycles per second. In North America, mains electricity supplies operate
at 60Hz; most of the rest of the world uses 50Hz. In aircraft the filter should norm ally be set to
50Hz. In remote land and maritim e applications the local voltage could be either 50Hz or 60Hz.
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Wait for the ECG trace to stabilise (like the trace shown above), ask the patient to breath in and
out and then to hold their breath for 10 seconds before pressing ‘record’ If the trace does not
stabilise, check the following:

Patient should not be moving

The apron should be aligned correctly

The wrist electrodes should be on the correct sides

The hip electrode should be on the left hip

All the electrodes should be in good contact with the skin (use plenty of the spray if in
doubt).
If you are not satisfied with the EGC trace e.g. it is unstable on som e or all of the traces, you
can press the ECG Assistant button on the touchscreen. This will ask you to confirm which part
of the ECG you are dissatisfied with and will then offer m ore detailed instructions on the
application of the ECG harness based on which traces you have indicated are suspect.
8.2.2
Recording an ECG
Once the recording is com plete, the results will be displayed as shown in the following picture.
ECG Recorded
If the Tempus IC is connected to a Response Centre, it will autom atically start to transfer the
ECG file.
At this point you can press
to close the ECG view to return to the main screen or you can
press ‘m onitor’ on the touch screen to return to monitoring m ode. Note that if you turn the ECG
off at this point and then restart the ECG function later during the same incident (without
switching the Tem pus IC off), these results will be shown again. This m eans that you can view
the last ECG that was recorded from the patient.
CAUTION
It is essential that the Te mpus IC is switched off before it is conne cted to another
patient, otherwise information from one patient (e.g. an ECG recording) may be
confused with that taken from another patient.
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8.3
User/Operator Manual
Capnometer
To activate the Capnometer function, press
button on the device
The first step in the Capnometer help process will appear.
Follow the instructions provided on the iAssist help process to activate Capnometer.
Example of the Capnom eter Help Screen
WARNINGS
The Tempus IC is not intended for long term patient monitoring. There are no audible or
visible alarms.
The Tempus IC is not for apnoea detection. The Tempus IC has not been tested or
validated for use in apnoea detection.
CAUTION
Use of monitoring during continuous nebulised me dication delivery will result in
damage to the Tempus IC which is not covered by the warranty. Disconnect the
capnometer sample line from the Tempus IC or switch off the Te mpus IC during
me dication delivery.
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Notes
The capnom eter is not for use in conjunction with breathing or anaesthetic systems.
8.3.1
Understanding the Capnometer Results
The Capnom eter display has two elem ents. Measurements are made continuously (for 15
minutes after the capnometer has been activated) and are updated in real time. Measurem ents
are sent in real time to the Response Centre provided that the data link is active.
Once the Capnom eter is active, the
button will be shown next to the ETCO 2 results.
Pressing this button at any time will stop the Capnom eter immediately.
The Respiration Rate section contains a bar graph and digital display of the patient's breathing
rate, in respirations per minute (Rpm).

Note that extreme rates above 50Rpm are outside the range of the bar graph display but
will be shown accurately on the digital display.
The ETCO2 section gives the partial pressure of the exhaled CO 2 at the end of the breath. This
is displayed in bar graph and digital form.
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8.4 Thermometer
To activate the thermom eter, press
button on the device
The first instructions will be displayed.
Follow the instructions provided on the iAssist help process to use the therm ometer.
The therm ometer is the large white and green device. It connects to the Te mpus IC via
®
Bluetooth .
Example of the Temperature Help Screen
CAUTION
The thermometer provides fast, accurate te mperature me asure me nts on any patient into
which its probe can be inserted into the ear canal to vie w the tympanic me mbrane. It
can be considered for use on any patient above three (3) ye ars of age. Do not use the
thermome ter if the probe cannot be inserted into the ear canal.
The thermometer should always be used with a probe cover attached. Probe covers
should be replaced between each me asure ment.
Note that the therm ometer functionality is currently not enabled for US custom ers pending
regulatory clearance.
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Notes
Allow the therm ometer and the patient to acclimatise to the sam e ambient temperature before
taking tem perature readings.
Dirt, greasy films or moisture on the thermom eter lens may affect the accuracy of the
instrument.
Deposits of cerum en (ear wax) can affect the measurement.
Do not open the thermometer case. The therm ometer will require factory recalibration if the
case is opened.
Place the smooth side (not the adhesive side) of the probe cover to the connection ring.
The device should be checked for damage if it has been dropped.
Holding the thermom eter too long may cause a higher am bient temperature reading of the
probe. This could m ake the body temperature m easurem ent lower than usual.
Do not press the thermom eter button until instructed by the steps shown on the screen as the
device will not operate.
The therm ometer’s sensor requires a few seconds to stabilise at the measurement site before a
reading can be taken. If the m easurem ent button is pressed too quickly after the thermom eter
is inserted into the ear, the device may not be able to take a reading. In this event it will emit a
“double-beep” and flash a sym bol on its display (s ee section 10.3.2). In this event, place the
thermometer back into the patient’s ear (as per instructions), wait 6 seconds and then take the
reading.
The device should be checked for damage if it has been dropped.
Holding the thermom eter too long may cause a higher am bient temperature reading of the
probe. This could m ake the body temperature m easurem ent lower than usual.
The therm ometer is switched on and off using the “ON/MEM” button. Press the button briefly
once (when instructed by the on-screen instructions) to turn the thermom eter on. It will
automatically try to communicate with the Tempus IC over the Bluetooth® link. Press and hold
the ON/MEM button for 3 seconds to turn it off. Note that to extend the battery life the
thermometer will autom atically shut off if left idle for more than 1 minute.
Note that the thermom eter has a m emory of the last 10 readings it has taken. These will be
shown on the thermometer’s display (but not transmitted to the Tempus IC) if the ON/MEM
button is pressed after the device has been turned on e.g. if the button is pressed once it will
show the most recent reading (preceded by a “1”), if pressed twice it will show the reading
taken before that (preceded by a “2”) and so on. For this reason it is recommended that the
ON/MEM button is not pressed and also that the thermom eter display is not reviewed while
obtaining temperature readings.
The therm ometer is norm ally supplied set to read in Centigrade (ºC). If required, it can be
changed over to read in Fahrenheit (ºF). See section 12 for information on how to change the
thermometer reading. If the user wishes to switch the units that the thermom eter itself displays,
this can be achieved by pressing and holding the measurem ent button at the when turning the
thermometer on.
Note that holding the thermom eter too long m ay cause a higher ambient temperature reading
of the probe. This could m ake the body temperature measurement lower than usual.
Only use non-rechargeable batteries with the thermometer.
Do not attem pt to use, swap or pair the therm ometer with other Tempus IC units or other
devices. Consult RDT if you need replacement thermom eters.
Users are reminded to ONLY use the therm ometer within the range specified in section 13.1.5.
Due to its nature Bluetooth technology is wireless and therefore results may not be received
100% of the tim e. Risk factors for exam ple would include the user moving out of range during
the measurement or environmental factors e.g. building m aterials and construction design
reducing operational effectiveness. Users should note that if a reading is not received they
should repeat the process, if possible this should be done closer to the Tempus IC.
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Users should note that while the Bluetooth technology will operate in environments where other
Bluetooth devices are in use, operation can be affected if the num ber of other devices becomes
very high (e.g. there can be high densities of devices at trade shows). If issues with a
Bluetooth connection are experienced then the measurement should be attem pted again either
in a different environment (with less Bluetooth devices turned on locally) or closer to the
product.
Note that the thermom eter is only provided to custom ers outside of North Am erica. This
functionality will be provided to custom ers based in North Am erica once the relevant regulatory
approvals have been granted.
8.4.1
Using the Thermometer
When following the on-screen instructions, attention should be paid to the signals given out by
the therm ometer. If measurements are taken incorrectly (too quickly, at the wrong
measurement site etc.) then the thermometer’s display will show an error. Errors are discussed
in section 10.3.
It should be noted that once the thermom eter is turned on it will power itself off after 1 minute if
no buttons are pressed, therefore the onscreen instructions should be followed promptly after
the therm ometer has been turned on.
It is recommended that 3 measurements are taken from the same ear and the highest of the
three used.
8.4.2
Understanding the Thermometer Results
When measurem ents are m ade, they are time stam ped and sent to the Response Centre
provided that the data link is active.
The clinical repeatability of the therm ometer 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 0.21C across different parts of the body.
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8.5
User/Operator Manual
Glucometer3
To activate the Glucometer function, press
button on the device
The first Glucom eter help screen will appear.
Follow the instructions provided on the iAssist help process to activate Glucom eter.
Example of the Glucom eter Help Screen
WARNING
The GlucoTel meter is provided pre-set to provide results in mg/dl format ONLY.
The results shown on the Te mpus IC will be in mg/dl format for users based in North
America and in mmol/l format in all other areas.
CAUTIONS
Do not store the glucometer strips outside of the stated environmental limits. Ensure
that shelf life information is heeded.
Ensure that the instructions for use attached to the strips are heeded.
Note that the glucometer functionality is currently not enabled for US custom ers pending
regulatory clearance.
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Glucometer Notes
®
®
The glucometer used with the Tem pus IC is the GlucoTel meter m ade by BodyTel of
®
Germany. The Tempus IC uses the GlucoTel meter as it is intended i.e. to measure a
®
patient’s blood glucose and to transmit this over Bluetooth to a second device (the Tem pus IC)
for re-transmission. The only difference is that the measured result is forwarded to the
®
response centre that receives the Tem pus IC call rather than the BodyTel Centre.
®
The GlucoTel m eter measures the patient’s blood glucose levels and transmits them
®
wirelessly (over Bluetooth ) to the Tem pus IC.
®
The GlucoTel m eter has been labelled with a Tem pus IC badge on the top in order that it can
be visually associated with the Tempus in case the two products are separated. However the
®
meter rem ains a product of BodyTel and retains their labelling and contact details on the
labelling on the underside.
®
The user m anual for the GlucoTel m eter is provided on the same CD-ROM as this m anual.
®
While applicable extracts of the GlucoTel manual are reproduced in this manual, Users should
®
also read the m anual of the GlucoTel m eter to ensure they have familiarised themselves with
the device.
Do not insert objects (e.g. pins, paper clips etc.) through the hole on the RDT label on the top
face 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 attem pt to use, swap or pair the glucometer with other Tem pus IC units or other
devices. Consult RDT if you need replacement glucom eters.
Users are reminded to ONLY use the glucometer within the range specified in section 13.1.6.
Due to its nature Bluetooth technology is wireless and therefore results may not be received
100% of the tim e. Risk factors for exam ple would include the user moving out of range during
the measurement or environmental factors e.g. building m aterials and construction design
reducing operational effectiveness. Users should note that if a reading is not received they
should repeat the process, if possible this should be done closer to the Tempus IC.
Users should note that while the Bluetooth technology will operate in environments where other
Bluetooth devices are in use, operation can be affected if the num ber of other devices becomes
very high (e.g. there can be high densities of devices at trade shows). If issues with a
Bluetooth connection are experienced then the measurement should be attem pted again either
in a different environment (with less Bluetooth devices turned on locally) or closer to the
product.
If the Tempus displays a reading of HIGH or LOW from the glucometer then this corresponds to
a value of >525mg/dl or <20mg/dl respectively.
Note that the glucom eter is only provided to custom ers outside of North Am erica. This
functionality will be provided to custom ers based in North Am erica once the relevant regulatory
approvals have been granted.
Lancet Notes
For use with the glucometer, RDT supplies the “SAFE Press” sterile safety lancets
manufactured by Vitrex Medical A/S of Denmark.
These are single use devices which are supplied sterile and are labelled accordingly.
Users should follow the on-screen instructions for using, discarding and repacking the
glucometer as these include the relevant information on the use of the lancets.
Users should not use lancets if the protective cap has been rem oved.
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8.5.1
User/Operator Manual
Testing the Glucometer
®
The GlucoTel m eter can be tested by pressing the
button, following the onscreen
instructions and then applying the control solution (either HIGH or LOW) as described in
®
section 4.7 of the GlucoTel manual.
8.5.2
Understanding the Glucometer Results
When measurem ents are m ade, they are time stam ped and sent to the Response Centre
provided that the data link is active.
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8.6
User/Operator Manual
Digital Camera
When requested by the Response Centre, it is possible to capture and send still digital pictures
using the cam era built into the device. Digital pictures are shown live on the Tem pus IC screen
so that you can see what the camera is seeing. When you are happy with the displayed im age,
you capture the picture and can then send it to the Response Centre (if you are not connected
the im age will be stored for transmission later).
To activate the Camera, press
button on the device
The first Camera help screen will appear.
A digital picture from the cam era will appear on the Tem pus IC display in the position shown in the
following picture.
Follow the instructions provided on the iAssist help process to take a photo.
Example of the Te mpus IC Display Showing Location of Digital picture
NOTE:
The Te mpus IC will go into the cam era process as soon as the voice
connection has started dialling.
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Example of the Te mpus IC Display Showing Photo Im age
Aim the camera so that you get the picture you need on the screen (e.g. a close-up of the patient).
When you are happy that the displayed image shows what you want, press
screen to freeze the image.
on the touch
A countdown will appear on the screen before the picture is sent. To discard the image during the
countdown and take another picture, press
countdown reaches zero.
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If you are connected over either an Ethernet or WiFi link, it will be possible to send m oving video to
the Response Centre.
This can be done in two ways:

Press the “Transmit Video” button. The “Camera and Video Options” dialog will stay on the
screen and the Response Centre will see what you see in the viewfinder window on the left
hand side of the dialog.
Example of the Te mpus IC Transmitting Video

Press the “Transmit Video in Background” button. The “Camera and Video Options” dialog
will disappear from the screen; you will be able to see that video is being transmitted
because a video icon will appear at the top of the screen. This feature is intended to allow
users to transmit video while using other features of the device. Users should note that
when the Tempus IC has its foot deployed, the angle of the cam era should enable them to
frame a patient without the need to hold the Tempus in position.
Video Icon
NOTE:
Moving video is intended to give the Response Centre the ability to see the
patient moving or to see around the patient’s environment. Users should
remem ber that the resolution and quality of the received video stream will not
be the sam e as they see on the screen of the Tempus IC due to the effects of
the video being compressed during transmission. This effect is lessened when
the im age being filmed is more stable or has less activity in it. Therefore in
order to ensure the received video is good quality, Users should try to move the
camera slowly. If rapid movement of the cam era is necessary then the
received image is likely to be have a temporarily lower level of resolution (will
appear “blocky”) while the camera is being moved around, this effect will
reduce once the camera m ovem ent is reduced.
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NOTE:
8.6.1
The overall image quality and resolution of the camera is greater for still
pictures than moving video. If the Response Centre require an image with a
reasonable level of detail (such as a close-up image) then a still photo would
probably be more suitable.
Annotation of Digital pictures
Im ages transmitted from the Tem pus IC can be altered using the software at the Response Centre.
The altered image can then be sent back to the Tem pus IC to act as a support in the remote
diagnostic procedure i.e. the physician can send pictures back that can be used to confirm exactly
the issue being examined or discussed, thus avoiding the danger of m isunderstanding verbal
descriptions.
Im ages can be amended using the following tools:

Zooming in and out

Addition of text

Addition of circles

Addition of lines and arrows

Addition of free-form lines

Selection of colours for added graphics
8.7
Interacting with the Response Centre
8.7.1
The Response Centre
Although the Tempus IC m ay be used without connection to a Response Centre (i.e. if there is
a physician locally or if the unit is being used to collect data for later transmission), in most
incidents it is likely that a Response Centre will be contacted as the first priority after having
activated the device. Each Tem pus IC device is pre-configured to dial autom atically to a
specific Response Centre. The centre should be staffed 24 hours a day, 365 days a year and
be always able waiting to receive your connection. If a connection cannot be established, you
should wait a short tim e and attempt to connect again.
The Tempus IC is designed to allow m aximum ease of use for the operator (even extending to
partial remote control by the Response Centre if necessary) and also to transmit the medical
data to the Response Centre. It is the function of the Response Centre staff to help control the
situation, make an assessment based on the data received and to offer advice on the
appropriate steps to take.
When interacting with the Response Centre staff, please carry out all of their instructions to the
best of your ability. If anything is not obvious, do not hesitate to ask for clarification or further
guidance. Most incidents will begin with the Response Centre staff asking questions relating to
the nature of the incident. These questions may include such areas as:

Nature of the patient e.g. name, sex, age, doctor’s details

Nature of the problem e.g. perceived symptoms, known history (has the patient been
monitored using the Tempus IC before)

Nature of the incident e.g. where the incident is taking place, who is responsible for the
remote location
When interacting with the Response centre staff, you should also realise that they will almost
always be operating in a different tim e zone to the one where the incident is taking place.
However, the time of the both the Tem pus IC and the Tempus Monitoring Station (the
Response Centre hardware) are pre-set to operate on GMT (Greenwich Mean Time).
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8.7.2
User/Operator Manual
Remote Viewing and Control
The Response Centre operators will have exactly the same information on their screens as
those displayed on the Tem pus IC. Should the Tempus IC display change e.g. if a new help
screen is brought up, new data is displayed or an error message appears, the Response
Centre system will display exactly the same inform ation a few seconds later. The only
exceptions to this are when you are taking a digital picture or when you are monitoring or
recording an ECG, in these situations the Response Centre only see that you are in the
process of recording the ECG or taking the photo but they don’t see the ECG or photo until its
has been downloaded.
Since the Response Centre can see what you see on the device, and since they can control it
remotely, if you are experiencing problems using the Tem pus IC, they can guide and support
you in its use.
If the Response Centre need to operate the Tempus IC remotely, they should m ake you aware
that they are activating a function of the device before they do so. Ideally the Response Centre
will only take control of the Tempus IC if the operator is having difficulty with an operation.
8.8
Recording Data Off-line and Transmitting On-line
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
Although the Te mpus IC is generally intended to be used whilst connected from the rem ote
location to a Response Centre, the Tempus IC can also be used without the telecoms
connection having been made. All the functions of the Te mpus IC operate normally if the
telecoms connections are not made and data can be taken from a patient using all of the
medical devices that the Tempus IC provides.
Naturally, if a connection has not been established, no data or photographs can be transmitted
and there will be no voice connection to the Response Centre operator. However, if the
Tempus IC is used on a patient without a connection being made, the data is stored and
automatically transmitted once the device is connected. If the device is turned off before it is
connected the data will not be saved.
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8.9
User/Operator Manual
GPS Location
The Tempus IC has a built-in GPS receiver. You can access this feature from the Help menu.
The GPS Button
Having pressed the GPS button, you will be shown a graphic instructing you to use the feature
when outside with a clear view of the sky.
GPS Help Instruction
NOTE:
The GPS operation will be limited if the Tempus IC is not used outside with a
clear view of the sky.
NOTE:
The GPS is intended to provide the User and Response Centre with the
patient’s location. It should not be used as a guidance or navigation device.
NOTE:
The Te mpus IC will be supplied with the GPS enabled in non-aviation modes
and enabled in all other modes. To turn the GPS receiver on or off, refer to
section 12.
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GPS Fix Obtained
The GPS may take up to 2 minutes to display a fix. If it unable to obtain a fix (if the view of the sky
is obstructed or if the unit is used indoors) then it will display an error.
The most recent fix (with the time and date of the fix) is always displayed.
If the signal from only a lim ited number of GPS positioning satellites can be received by the Tem pus
(e.g. because of partial blocking of the sky by objects, buildings etc.) then the fix may be less
accurate. In this case the fix will be labelled “Approxim ate fix” and the reading m ay be +/-2.5km.
8.10
Actions after Use – Turning the Tempus IC Off
Before switching the Tempus IC off, you should m ake sure that it is not in use. Make sure that
the voice and data links are not in use and that the device is not being used to m onitor a patient
off-line.
Press and hold the On/Off switch
for 3 seconds. The system will then bring up the dialog
shown below and give a 10 second countdown.
The lamp on the On/Off button will change from solid green to flashing orange.
When shutting down, the Te mpus IC will show dialog containing a countdown tim er from ten
seconds. The dialog reminds you to clean and repack Te mpus IC using the icon provided.
Option A:
Press
screen.
to stop the countdown and bring up the Instrum ent readings and results
Option B:
Press
to stop the countdown and bring up the Cleaning & Repacking Menu iAssist
help process.
Option C:
Let the unit shutdown.
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Example of the Shutdown Screen
8.10.1
Logging Maintenance Requirements
If consumable items such as the repack kit or a cannula have been used, the Tempus IC will
alert you to the need to report the need for these items to be replaced. This alert will be
provided after the shut down has been initiated.
In addition to flagging the need for certain consumable items to be replaced, the alert will also
inform you if:

batteries are depleted;

if specific errors have occurred;

or if a software update is required.
You should use the inform ation displayed to log or report that the Tem pus IC requires your
maintenance staff to provide indicated items.
NOTE:
This feature DOES NOT indicate that the Tem pus has developed a fault. This feature is to
help remind users to report that basic consumable items or m aintenance activities are
required. Users should not report the information displayed by this feature as a fault to RDT.
Example of the Shutdown Screen
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In the example above, the Tempus IC is indicating that the battery is now below 25% charge.
RDT recommends that users respond to the information posted to ensure that the Tem pus IC is
maintained in good working order.
The potential conditions that can be logged are:
Text
Condition
Battery charge below 70%
The battery charge is below 70% of its potential full
capacity
Battery charge below 50%
The battery charge is below 50% of its potential full
capacity
Battery charge below 25%
Or < 25%
Repack kit required
If “Final Check” process was completed using the “Yes”
daughter process
Capnom eter cannula required
If Capnom eter was started during the incident
Glucom eter repack kit required
If the glucom eter repack process was followed
Thermometer battery required
If the therm ometer battery low error was reported during
incident
Glucom eter battery required
If the glucom eter battery low was reported during incident
Software update required
If software update was notified during incident*
Device fault reported
If any device was disabled due to a fault
*If a software update is required you should refer to your maintenance manual for instructions
on how to perform this process.
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9.1
User/Operator Manual
After Using the Tempus IC
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
Cleaning the Tempus IC
It is necessary to clean the Tempus IC after use.
The screen m ay be cleaned using a proprietary screen cleaning wipe of the type used for other
LCD screens. Under no circumstances should any abrasive substance be applied to the
screen.
The Te mpus IC instruments must be cleaned during the re-packing process.
If the Tempus IC is dirty it should be cleaned with to rem ove any cosmetic contamination. It
should be wiped down with a soft cloth, which m ay optionally be dampened with water and a
mild detergent solution.
The screen m ay be cleaned using a proprietary screen cleaning wipe of the type used for other
LCD screens. Under no circumstances should any abrasive substance be applied to the
screen.
The outer case of the Te mpus IC should be cleaned to rem ove any cosmetic contamination. It
should be wiped down with a soft cloth, which m ay optionally be dampened with water and a
mild detergent solution.
9.1.1
Cleaning the Thermometer
The probe is the most delicate part of the thermom eter. It should be used with care when
cleaning the lens to avoid dam age.
Keep the unit dry and away from any liquids and direct sunlight.
The therm ometer should not be subm erged into liquids.
If the therm ometer is accidentally used without a probe cover, clean the probe as follows:
9.1.2
1.
Use a cotton swab dosed with the Alcohol (70% concentration) to clean the lens on
the end of the thermom eter.
2.
Allow the probe to fully dry for at least 1 minute before using it.
Cleaning the Glucometer
If 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 instrum ent.
2. After maintenance check the meter with control solution to ensure that it is functioning
properly.
3. The GlucoTel or labeling will not be dam aged or permanently discolored by cleaning with
alcohol (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.
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9.2
User/Operator Manual
Cleaning and Re-packing Help Screen
The user can get help at any tim e by pressing the
button at any tim e. This will bring up the
Help Menu. There are m ultiple sequential m enus covering different aspects of using the device
When the first Help Menu is on the screen, the next menu (Cleaning and Repacking Menu) can
be accessed by pressing the Next touchscreen button.
WARNING:
The fluid contained within the wipes will cause tem porary dam age to the eye.
In the event of contact to the eye, wash thoroughly with water for 15 minutes.
Wash hands with soap and water after use
WARNING:
Keep wipes away from open flam e
NOTE:
Wiped surfaces m ust be left wet for at least 1 minute.
NOTE:
Wipes are not to be used as baby wipes.
NOTE:
The wipes are not to be used to disinfect surfaces that have been soiled with
internal bodily fluids (other than sweat). If such soiling has occurred, the item
should not be used and should be returned to RDT.
From the Help
Menu, press the
Next button to
bring up the
Cleaning and
Repacking Menu
Example of the Help Menu
The user can press any one of the following icons on the touch screen to get help cleaning and
repacking the device.
Example of the Cleaning and Repacking Menu
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The user can m ove backwards and forwards through the iAssist help processes by pressing the
Next and Previous touchscreen buttons.
It is important that you follow all the applicable repacking steps starting with ECG Harness,
through to the Pulse Oxim eter repack process, then following with the Connection Cables and
finishing with Final Check. It is im portant that you always perform the Final Check process.
Suitable cleaning wipes labelled "Alcowipe" are provided within the Te mpus IC. The help
screen shows the location of the wipes and the user must follow the instructions provided on
the iAssist help process to clean and repack the device.
9.3
Single-Use Devices
The following accessories are single-use devices and m ust be discarded after use. No
particular precautions are required when disposing of these items provided that they are not
contaminated with bodily fluids. In case of such contam ination, the items should be disposed
of in accordance with local regulations.
Part De scription:

AlcoWipes

Nail Varnish Wipes

Capnom eter cannulae

Glucom eter strips

Lancets

Gloves
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10
Maintenance, Servicing and
Troubleshooting
10.1
General
The Te mpus IC is designed to be as m aintenance-free as possible. The only user-replaceable
and user-serviceable parts in the Te mpus IC are those listed in this section of the m anual.
More details on maintenance are given in the Tempus IC Maintenance Manual pn. 41-1002
which is supplied on the sam e CD-ROM as this m anual.
NOTE:
If the Tempus IC is no longer serviceable and is beyond repair, it may be
scrapped. Scrapping the device and its accessories must be perform ed in
compliance with applicable local regulations. It should be noted that special
conditions may apply to the rechargeable battery if it is required to be
scrapped. The battery should be discharged before scrapping and should not
be crushed or incinerated.
10.2
Battery Management
10.2.1
The Battery
The Te mpus IC contains a rem ovable, rechargeable battery.
Example of the Battery Front
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Example of the Battery Rear
In norm al usage, the rechargeable battery provides power for at least 4 hours' continuous* use
when fully charged.
Every battery is provided with an integral battery life indicator which is also visible through the
front panel of the case.
The battery life should be m onitored periodically over tim e when the device is in storage and
also before and after use.
NOTE:
RDT recommends that the battery charge status should be checked once a
year and recharged if necessary. RDT also recomm ends that the battery be
completely discharged and recharged once a year.
NOTE:
The User should remem ber that battery life of older batteries will not be the
same as new batteries.
By m onitoring the remaining battery life, situations where the battery is too weak to power the
Tempus IC for the duration of an incident can be avoided. If the battery strength indicator
shows less than 25% power remaining, you should change the battery if possible to ensure that
there is adequate power for the next time it is needed.
Using the battery down to the point where it is com pletely empty will not cause any hazards or
dam age to the system.
*Assessment of use is based on projections of reasonable device usage within a patient incident made by RDT.
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10.2.1.1
User/Operator Manual
Checking the Charge of the Battery
Example of the Battery Life Indicator Showing Full Charge
The charge state of the battery can be obtained by pressing the button on the front.
The battery is provided with 4 charge state LEDs. Pressing the button will light one or m ore
lights. Each light corresponds to 25% of the charge state of the battery in the order (from
highest to lowest):

Green – 76-100%

Green – 51-75%

Am ber – 26-50%

Red – 1-25%
NOTE:
If the red light is flashing the battery has 10% or less charge remaining.
These will light cum ulatively when the battery button is pressed i.e. only the red light will light if
the charge state is 1-25% after which the am ber light will light as well.
The charge state of the battery can be checked while the Te mpus IC is in its storage Bag.
Window to check
the battery
Example of the Te mpus IC Bag
Pressing the battery button behind the window will light one to four coloured lights.
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The Te mpus IC does not need to be rem oved or turned on to check the battery.
10.2.2
Removing the Battery from the Tempus IC
To replace the battery:
First check the replacement battery has sufficient charge by checking its indicator.
Next, ensure the Tem pus is switched off. Then remove the battery by squeezing the
two latches inwards, then pull the battery away.
Example of the Battery Indicator
WARNING:
Do not short-circ uit the term inals of any battery. A short circuit can occur if the
battery term inals com e into contact with any metal or other electrically
conductive object. The battery m ay be irreversibly damaged if it is shortcircuited.
NOTE:
Before rem oving the battery you must switch off the Tem pus IC by pressing
and holding the power button for two seconds.
NOTE:
Remem ber that the battery cannot be rem oved until the red lamp on the front
panel has gone out.
Slide the new battery all the way into the Tem pus until it clicks into place on both sides.
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Fitting the Battery
10.2.3
Charging the Battery
The battery can be charged either when it is fitted to the Tempus IC or when it is removed from
the separate battery charger.
WARNING:
10.2.3.1
Do not attem pt to charge the battery using any charger other than those
supplied by RDT.
Charging the Battery when Attached to the Tempus IC
1.
When fitted to the Te mpus IC, the battery can be charged by connecting the power
supply (part number 01-1017) to the 3 pin connector on the right hand side of the
Tempus.
2.
When the power supply is attached to the Te mpus IC, the green power light on the
Tempus IC front panel will turn on.
3.
If a battery is attached the green charge light will flash. The lights on the battery will
light solidly up to the charge state of the battery at the time.
The PSU Plug Attached to the Te mpus IC Connector
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Power Light
Battery
Charge Light
The Power Light and the Charge Light
10.2.3.2
NOTE:
Power supply is rated 110-240V 50-60Hz 1.5A.
NOTE:
Charge times of the battery will vary depending on the how the Te mpus IC is
being used. If the Tempus is switched off charging will be faster than if the
Tempus is on and all features are being used.
NOTE:
Charging a completely em pty battery will take 6 hours when the Te mpus IC is
switched off.
Using the Battery Charger
When the battery is separate from the Te mpus IC, the battery may be charged by connecting it
to the battery charger (part number 01-1012). To attach the charger to the battery, the clip
must be firmly pressed onto the connections of the battery. Note that the clip of the charger
can only be connected to the battery in one way.
The Battery Connector Attached to the Battery
1. Clip the charger to the battery (the clip only attaches in one way).
2. Attach the charger to the main supply.
3. The charger’s LED will light orange (for approximately 0-85% charge), change to yellow
during charging (at approximately 86-100% charge) and will turn green when finished. If the
battery is only partially discharged then the LED may start on yellow.
NOTE:
Battery charger is rated at 100-240V 50-60Hz 0.9A.
NOTE:
Recharging the battery takes up to 6 hours for a fully discharged battery.
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10.2.4
Tempus IC Battery Shelf Life
10.2.4.1
Shelf Life of Batteries Stored as Spares
A new and fully charged battery retains approximately 70% of its charge after 12 months in
storage detached from the Te mpus IC. This equates to approximately 4 hours of use.
10.2.4.2
NOTE:
RDT recommends that the battery is topped up annually.
NOTE:
Specifications for the battery are based on a new, fully charged battery. Shelf
life ratings are based on new, fully charged packs which are stored separately
from the device at 20C. Shelf life performance will decrease over time and will
be lower if the battery is stored in higher or lower am bient temperatures.
Shelf Life of Batteries Stored in the Tempus IC
A new and fully charged battery retains approximately 60% of its charge after 12 months in
storage attached to the Te mpus 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. Shelf
life ratings are based on new, fully charged packs which are stored separately
from the device at 20C. Shelf life performance will decrease over time and will
be lower if the battery is stored in higher or lower am bient temperatures.
10.2.5
Other Tempus IC Batteries
10.2.5.1
Wireless Headset Battery
The headset contains a rechargeable battery. The battery of the headset is not userreplaceable and does not require user intervention. In the unlikely event that the headset’s
battery becom es completely exhausted and can no longer hold charge, a replacem ent headset
can be purchased.
10.2.5.1.1 Charging the Headset
RDT do not supply a separate charger for the headset. The charger is built into the Tem pus IC.
You must follow the repacking instructions provided by the Tempus IC on screen. These will
instruct you to clean the headset after use and to replace it on its docking pin before shutting
down.
If you do not replace the headset then the Tempus will show an error advising that the headset
should be refitted.
Placing the headset onto the docking pin enables the Tempus IC to recharge it. The Tempus
IC recharges the headset for up to 4 hours 30 m inutes (apx) every time the headset is
replaced. The charging cycle will continue regardless if the Tempus IC is switched on or off.
Charging is started as soon as the headset is fitted to the docking pin. The indicator light on
the headset will light red for the duration of the charging process although it m ay switch off
intermittently for 8 second periods (this is part of the charging process). The indicator light will
go off when charging is complete – which could be less than the 4 hour 30 minute m aximum
cycle tim e depending on how depleted the headset battery is.
In addition, the Tem pus IC will top up the charge of the headset approxim ately 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 em pty (less
than 5% charge).
Caution:
Do not attem pt to charge the headset using any other charging device. This
will automatically suspend the warranty and could be dangerous.
Note:
The headset has a life of up to 500 charge cycles.
10.2.5.1.2 General Guidelines for Safe Use

Do not drop or try to alter the shape of your headset.
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
Do not expose the headset to liquid or moisture. Unlike the Tempus, the headset has
no protection against ingress of solids or liquids.

Do not expose your headset to extrem e temperatures. The tem perature range of the
headset is 0-40C.

Do not try to disassem bly your headset. Service and Maintenance can only be
perform ed by RDT.

Do not let children play with the headset since it contains sm all parts that could
becom e detached and create a choking hazard.
CAUTION:
Danger of explosion if battery is incorrectly replaced. Do not attempt to repair
or replace the battery. If the battery is worn out a new headset is required
from RDT. Dispose of the headset in accordance with local regulations. Do
not dispose as household waste.
®
The user m anual for the Bluetrek G3 headset is supplied on the same CD-ROM as this
®
manual. Details from that manual have been reproduced in this section courtesy of Bluetrek .
10.2.5.2
The Glucometer Batteries
The glucometer is powered by user replaceable non-rechargeable batteries. The batteries are
conventional types that are available from common retail and industry sources.
The glucometer is powered by 2 AAA type batteries.
These batteries are rated with a shelf life of 7 years at 20C.
RDT recomm ends that these are replaced annually when used in a commercial airlin e
application (once a week). Higher levels of usage (e.g. in a training departm ent) may requir e
the batteries to be changed more often.
RDT recommends that Varta PowerOne alkaline batteries are used, although many other types
are commonly available. Replacem ent batteries do not need to be sourc ed from RDT.
10.2.5.2.1 Changing the Glucometer Battery
To change the glucometer battery:

First push back the battery cover

Then rem ove the batteries and dispose of them.

Then replace the batteries with new units of the same type and ratings. Note that the
batteries m ust be inserted in the orientation shown on the inside of the plastic case of
the device.
Removing the Glucometer Battery Cover
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10.2.5.3
User/Operator Manual
The Thermometer Battery
The therm ometer is powered by a user replaceable non-rechargeable battery. The battery is a
conventional type that is available from common retail and industry sources.
The therm ometer 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 applicatio n
(once a week). Higher levels of usage (e.g. in a training department) m ay require the batteries
to be changed more often.
RDT recommends that Varta batteries are used, although many other types are commonl y
available. Replacem ent batteries do not need to be sourc ed from RDT.
10.2.5.3.1 Changing the Thermometer Battery
To change the therm ometer battery:

First push back the battery cover
Removing the Thermom eter Battery Cover
10.2.6

Then rem ove the battery and dispose of it.

Then replace the battery with a new unit of the same type and ratings. Note that the
battery m ust be inserted in the orientation shown on the inside of the plastic case of the
device.
Disposal of Batteries
Dispose of batteries in accordance with the applicable local regulations (these can vary from
country to country).
In most countries, the trashing of used batteries is forbidden and the end-users are invited to dispose them
properly, e ven tually through not-for-pro fit profi t organisations, mandated by local go vernments or organised on a
voluntary basis by professionals.
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10.3
User/Operator Manual
Troubleshooting
Occasionally, problems may occur with the Te mpus IC. Operator error, sensor problems or a
failure within the Tempus IC could cause these problems. In most instances, the Tempus IC
will display an error m essage on the screen. This section describes the possible error
messages and what they mean.
All of the error messages take the form of a window which appears in the middle of the screen.
The window contains the following text:

a title which identifies the sensor or system which is having trouble

a description of the problem

the effect that the error will have on the performance of the Tem pus

which button to press to clear the error m essage off the screen.
CAUTION:
10.3.1
In the event that the Tempus IC displays an error that is not described within
this m anual e.g. Windows applications errors, turn the Te mpus IC off and then
on again. This should clear the error and allow normal operation to resume.
Do not continue to use the device if such an error is displayed. If symptoms
persist, please contact RDT
Errors
When the device encounters a problem it will display a dialog on the screen. The speaker will
announce the message “Attention” followed by the name of the part of the product that the
message is concerned with e.g. “Attention – Pulse Oxim eter”.
The audible alerts are on are played every 5 seconds while an error is being displayed, until the
error is cleared. The alert will be played back both through the speaker and the headset.
The different error dialogs are shown below.
Audio Message
Text Message
Attention Pulse
Oxim eter
There is a fault with the Pulse Oximeter
It has been disabled
Attention
Capnom eter
Capnom eter is blocked.
Disconnect and reconnect the cannula.
Check the cannula for blockages, or kinks.
Attention
Capnom eter
The cannula is not plugged into the capnom eter.
Attention
Capnom eter
There is a fault with the Capnometer
It has been disabled
Attention
Capnom eter
Capnom eter is not plugged in.
Attention
Capnom eter
Attention
Capnom eter
Attention
Capnom eter
Attention Blood
Pressure Meter
Repeat step 7 of the instructions.
Repeat step 2 of the instructions.
Capnom eter sensor error or range error.
Capnom eter zero required.
Sop and restart Capnometer.
No Capnom eter is available on this unit.
There is a fault with the BP m eter.
It has been disabled
Attention ECG
An error occurred with the ECG
Please restart the ECG and try again
Attention ECG
There is a fault with the ECG
It has been disabled
Attention Battery
There is approxim ately 60 minutes of battery remaining
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Audio Message
Attention Battery
Text Message
There is less than 30 m inutes 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 down
Attention Connection
Tempus is already trying to m ake a connection
Attention Connection
Tempus is already connected.
Attention Connection
The Tempus is connected so the mode cannot be changed.
Attention Connection
You have not com pleted the data connection process. Are you sure
this is what you want to do?
Attention Connection
Response centre is not responding
Attention Headset
The headset has not connected to the Tempus.
Repeat step 3 of the instructions.
Attention Connection
Headset should be replaced before shutdown
Attention Connection
You have not com pleted the data connection process. Are you sure
this is what you want to do?
Attention Connection
You have not com pleted the voice connection process. Are you sure
this is what you want to do?
Attention Shutdown
Attention Shutdown
A fault has occurred. To clear the problem Tem pus will switch off.
Please switch back on once the shutdown is complete. If the problem
persists please contact your supplier.
Due to low room tem perature Tempus cannot be used and will
shutdown. Please allow to warm and restart later.
Attention Shutdown
Due to high room tem perature Tempus cannot be used and will
shutdown. Please allow to cool and restart later.
Attention Shutdown
The battery is em pty. Tem pus will perform a managed switch-off. The
battery should be changed.
Attention Headset
Attention – Headset
Error
Please wait, setting up connection to the headset.
Headset should be replaced before shutdown
A fault has occurred
To clear the problem Tempus will switch off
Please switch back on once the shut-down is com plete.
If the problem persists please contact your supplier
10.3.2
Attention Battery
The battery is em pty.
Tempus will perform a managed switch-off.
The battery should be changed.
Attention Headset
Please wait setting up connection to Headset
Thermometer Errors
The thermometer display can show a range of error conditions and feedback
messages. The thermometer display should be referred to during its use to
ensure that this information is seen and responded to.
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Error Message
Proble m
Device stabilization in process.
Battery is low and no m ore
measurements are possible.
Measurement before device
stabilization.
Repeat the reading (after flashing
has stopped) but wait a few
seconds after the thermom eter
has been inserted into the ear
before you press the
measurement button
Replace the battery.
Repeat the reading (after flashing
has stopped) but wait a few
seconds after the thermom eter
has been inserted into the ear
before you press the
measurement button
The device showing a rapid
ambient temperature change.
Allow the therm ometer to rest in a
room for at least 30 minutes at
room tem perature: 10°C and
40°C.
The am bient temperature is not
within the range between 10°C
and 40°C.
Allow the therm ometer to rest in a
room at least 30 minutes at room
temperature: 10°C and 40°C
Error 5~9, the system is not
functioning properly.
Unload the battery, wait for 1
minute and repower it. If the
message reappears, contact the
retailer for service.
Temperature taken is higher than
42.2°C.
Check the integrity of the probe
cover and take a new temperature
measurement.
Temperature taken is lower than
34°C.
Make sure the probe cover is
clean and take a new temperature
measurement.
Device can not be powered on to
the ready stage.
10.3.3
Solution
Change with a new battery.
Glucometer Errors
The glucometer display can show a range of error conditions and feedback
messages. The glucometer display should be referred to during its use to
ensure that this information is seen and responded to.
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Error Message
Proble m
Solution
Lo
Reading is below 20 mg/dl (1.1
mmol/l).
Check calibration and retry
reading.
Hi
Reading is above 525 m g/dl (29.2
mmol/l).
Check calibration and retry
reading.
E50
Internal meter tem perature too
low.
Allow the meter to warm up to
room tem perature.
E51
Internal meter tem perature too
high.
Allow m eter to cool to room
temperature.
E63
Strip removed during countdown.
Test again and leave strip in the
meter until a result is displayed.
E70
Cell phone pairing failed.
Repeat pairing process.
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11
Spares List
11.1
Spares List of the Tempus IC
The following user-replaceable accessories and consumables are available from the RDT.
01-1001
Battery Pack
01-1002
Blood Pressure Cuff – Adult
01-1003
Blood Pressure Cuff – Large Adult
01-1004
Blood Pressure Cuff – Child
01-1005
Lo-Flo Capnometer
01-1006
Blood Pressure Hose
01-1007
Capnom eter Cannula - Adult Nasal
01-1008
Pulse Oximeter Sensor
01-1009
Extension Reel
01-1010
12 Lead ECG Harness
01-1011
Bluetooth Therm ometer
01-1012
Battery Charger
01-1013
Bluetooth Glucometer
01-1014
Dual Modem Cable
01-1015
Mains Cable Pack
01-1016
Bag (em pty)
01-1017
Mains Power Supply
01-1018
Bluetrek Headset
01-1019
Wired Headset
01-1020
Consumables Replenishment Kit
01-1021
Ethernet Cable
01-1022
USB Serial Cable
01-1023
Ethernet – POTS adaptor
01-1024
Glucom eter replenishm ent kit
01-1025
ECG wrist straps
01-1027
Glucom eter Control Solution Set
02-1001
Accessory Pouch (note – only supplied to commercial airlines)
®
®
®
®
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User/Operator Manual
Configuring the Tempus IC
NOTE:
The iAssist help processes on your Te mpus IC m ay differ from this exam ple
iAssist help process in the following sections. However the process always
follows the sam e key elements.
NOTE:
Always ensure that you read the complete iAssist help process in order and do
exactly what it requires.
A number of the parameters used by Te mpus IC are configurable to suit certain requirem ents.
To configure the device, press the
button to bring up the Help Menu. Then to access the
Settings menu press Cleaning and Repacking touchscreen button followed by pressing the
Settings touchscreen button.
The Help Menu
Press the
touchscreen
here
Press the
touchscreen
here
The Cleaning and Repacking Menu
Press the Settings button in the Cleaning & Repacking Menu on the touchscreen to bring up
the Settings Menu.
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Press the
touchscreen
here to configure
the device
Press the
touchscreen
here for the m ain
device settings
Settings Menu
Press the Settings button in the Settings Menu on the touchscreen to bring up the
configurable options.
System Settings
Press the
touchscreen
here
Press the touchscreen to select the configurable parameters and press OK touchscreen button
to confirm the changes you have made.
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Configuration Information
The configuration of the device can be seen in the configuration screen. .
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13
Specifications and Standards
13.1
Specifications
Note that all figures quoted are based on room temperature, pressure and humidity unless otherwise stated.
13.1.1
Non-invasive Blood Pressure
13.1.1.1
Adult cuff and Large Adult cuff ratings
13.1.1.2
13.1.2
Systolic:
60 - 250 mm Hg
Diastolic:
40 - 220 mm Hg
Range:
0 - 330 mm Hg
Accuracy:
± 3mm Hg or ± 2% (whichever is greater)
Resolution:
1 mm Hg
Maximum inflation:
330mm Hg
Child cuff ratings
Systolic:
60 - 250 mm Hg
Diastolic:
40 - 220 mm Hg
Range:
0 - 330 mm Hg
Accuracy:
± 3mm Hg or ± 2% (whichever is greater)
Resolution:
1 mm Hg
Maximum inflation:
330mm Hg
ECG Recorder
Gain/Sensitivity
5, 10, 20 mm/m V
Input Range
±6m V
Acquisition sample rate
1000 samples per second (com pressed to
500Hz with peak picking and averaging
algorithm)
Frequency response
0.05 to 175Hz ±3dB
Defibrillator protection
Patient leads are isolated from system and
operator, with 4kV protection
Common Mode Rejection
-60dB (minimum)
Leads Off Indicators
Connection status for each lead is shown on
Acquisition screen
Permanent Filters
High Pass: 0.05Hz 1st order
Low Pass: 170Hz 1st order
Baseline W ander: Baseline reset by adaptive
zeroing algorithm
Notch filter (Mains Noise Rejection)
50Hz 4th order Butterworth,
49.1Hz - 50.9Hz,
60Hz 4th order Butterworth,
59.1Hz - 60.9Hz
Low pass (Muscle Artifact Filter)
35Hz 4th order
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13.1.3
User/Operator Manual
ETC02 Sensor
Unless otherwise stated, all CO 2 measurem ents are made following an airway adapter zero,
with 5% CO2 gas, balance N2 at 25 degrees C, and Pb = 760 mm Hg with 2 litres per minute
flow. The stabilization tim e for full specification testing of the LoFlo Module over the entire
temperature range is 20 minutes.
Range:
0-100 BPM
Accuracy:
± 2 BPM
Range:
0-10% CO2 displayed value
Accuracy:
± 4%
Rise time:
<2 seconds
Delay tim e:
5 seconds
Operating altitude range:
0-15000 feet
The capnometer is automatically com pensated for local atmospheric pressure.
Physical characteristics:
Module weight is less than 9.6 oz (272.16 g)
Module Size: < 2.6" wide x 1.5" high x 3.5" deep [<
66.0 x 38.1 x 88.9 mm]
Cable length – 19 inches (46 cm)
Carbon Dioxide Monitoring
Mode of Sampling
Sidestream
Principle of Operation
Non-dispers ive infrared (NDIR) single beam optics, dual
wavelength, no moving parts.
Initialization Time
Measurement displayed in less than 20 seconds, At an
ambient temperature of 25° C, full specifications within 2
minutes.
CO2 Measurement Range
0 to 150 mm Hg 0 to 19.7% 0 to 20 kPa (Barometric Pressure
supplied by RDT Ltd)
CO2 Calculation Method
BTPS (Body Temperature Pressure Saturated)
CO2 Response Time
<3 seconds - includes transport time and rise time
CO2 Resolution
0.1 mm Hg 0 to 69 mm Hg 0.25 mmHg 70 to 150 mm Hg
CO2 Accuracy *
0 - 40 mmHg ± 2 mm Hg
41 - 70 mm Hg ± 5% of reading
71 - 100 mm Hg ± 8% of reading
101 - 150 mm Hg ± 10% of reading
Above 80 breath per minute ± 12% of reading
* NOTE: Gas temperature at 25° C.
CO2 Stability
Short Term Drift: Drift over four hours shall not exceed 0.8
mmHg maxim um. Long Term Drift: Accuracy specification will
be m aintained over a 120 hour period.
CO2 Noise
RMS noise of the sensor shall be less than or equal to 0.25
mmHg at 5% CO 2
Sampling Rate
100 Hz
Respiration Rate
Range 2 to 150 breaths per minute (BPM)
Respiration Rate
Accuracy
± 1 breath
Calibration
No routine user calibration required.
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Carbon Dioxide Monitoring
ETCO2 Calculation
Method: Peak of the expired CO 2 waveform
Selections: 1 breath, 10 second, 20 second
Inspired CO2
Measurement
Range: 3 to 50 mm Hg
Method: lowest reading of the CO 2 waveform in the previous
20 seconds
Selection: 20 seconds (not user-selectable)
Compensations (RDT Ltd
Controlled)
Compensations for: Expired O 2, Balance gas (N2, N2O, He)
and Anaesthetic Agents
Uses gas compensation information and barometric pressure
to correct the raw carbon dioxide value
O2 Compensation
Range: 0 to 100%
Resolution: 1%
Default: 16%
Airway Pressure
Range:
+ 120 cm H2O (88.27 mmhg)
- 45 cm H2O (33.1 mm Hg).
Anaesthetic Agent Effects
(MAC levels)
Cross-sensitivity
Compensation Error*
Anaesthetic Agent Sensitivity
(uncompensated)
Accuracy specification will be
maintained for halogenated
anaesthetic agents present at
accepted MAC (Minimum
Alveolar Concentration)
clinical levels.
Anaesthetic Agent Sensitivity
(compensated)
Testing at Agent levels
defined by accepted
regulatory standards (i.e. ISO
21647, ASTM F1456,
IEC/CDV 60601-2-55)
currently in process.
0-40 mm Hg: ± 1 mmHg additional error
41-70 mmHg: ± 2.5% additional error
71-100 mm Hg: ± 4% additional error
101-150 mm Hg: ± 5% additional error
* Additional worst case error when com pensation for Pb, O 2,
N2O, anaesthetic agents, or helium is correctly selected for the
actual fractional gas constituents present.
Gas or Vapour
Halothane
Enflurane
Isoflurane
Desflurane
MAC Level %
(v/v)
0.74
1.68
2.00
6.30
(From Olivier C. Wenker: Review of Currently Used Inhalation Anesthetics: Part I. The Internet
Journal of Anesthesiology, 1999, Volume 3 Number.)
Gas or Vapour
Gas Level
Quantitative Effects
Nitrous oxide
60%
No Additional Effect
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Gas or Vapour
Gas Level
Quantitative Effects
Halothane
4%
No Additional Effect
Enflurane
5%
No Additional Effect
Isoflurane
5%
No Additional Effect
Sevoflurane
5%
No Additional Effect
Xenon
80%
Negatively bias Carbon Dioxide values
by up to an additional 5 mmHg at 38
mmHg
Helium
50%
No Additional Effect
Metered dose inhaler
propellants
Unspecified
Unspecified
Desflurane
15%
Concentrations greater than 5% will
positively bias Carbon Dioxide values by
up to an additional 3 mmHg at 38
mmHg.
Ethanol
0. 1%
No Additional Effect
Isopropanol
0.1%
No Additional Effect
Acetone
0.1%
No Additional Effect
Methane
1%
No Additional Effect
Environmental:
Temperature and
Humidity Operating
0 to 40°C, 10 to 90% RH, non-c ondensing
Storage
-40 to 70°C, 10 to 90% RH, non-condensing
Water Resistance
IPX4 - Splash-proof - Module only (When Sample Cell is
inserted into Sample Cell Receptacle)
Shock Im pact
IEC TR 60721-4-7 Class 7M3 (designed to withstand
environments subject to significant vibrations or high shock
levels)
EN60068-2-27 Shock
EN60068-2-64 Random Vibration
13.1.4
Sp02 Sensor
Pulse Range:
25-300 bpm
Graphic display range:
25-175 bpm
Accuracy:
± 2bpm or ±2% whichever is greater
Resolution:
1bpm
Averaging:
8 seconds
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13.1.5
User/Operator Manual
SpO2 Range:
0-100%
Graphic display range:
50-100%
Accuracy:
±2% at 70%-100%
Resolution:
1%
Type:
Functional saturation (test methods available upon
request)
Wavelength range:
Red 660nm, infra-red 905nm
Perfusion Index range:
1-20%
Signal strength range:
1-7 bars
Thermometer
Temperature m easurem ent range:
34-42.2°C (93.2-108°F)
Operating temperature range:
10-40°C (50-104°F)
Storage tem perature Range:
-20-50°C (-4-122°F), RH85% (non-c ondensing)
Transportation tem perature:
<70°C, RH95% (non-c ondensing)
Compliance with:
ASTM E1965-98, EN12470-5:2003 Clinical
thermometers-Part 5:Performance of infra-red ear
thermometers(with maxim um device),IEC/EN606011-2(EMC),IEC/EN60601-1(Safety) standards.
Accuracy:
+/-0.2 C (0.4 F) between 35.5~42°C (95.9~107.6°F)
and +/-0.3 C (0.5 F) outside this range.
Display type:
oral equivalent
Range:
10m (free field)
Weight:
100g (including battery)
Battery:
3V CR2
Size:
167mm x 39mm x 45mm (max).
Environm ental range:
The therm ometer has the same environmental range
as the Tem pus IC, see section 13.1.7
Drop/Shock:
The therm ometer has been tested to the same range
of environmental standards as the Tem pus IC (see
section 13.1.7.1
RDT recomm ends that the batteries are replaced annually when used in a commercial airlin e
application (once a week). Higher levels of usage (e.g. in a training departm ent) may requir e
the batteries to be changed more often.
®
The Thermometer uses the Bluegiga WT12A Bluetooth module. This is unm odified by RDT
and is provided under FCC ID QOQWT12 under FCC part 15C and Industry Canada REL:
5123A-BGTWT12A under RSS210.
It operates in the frequency bands 2402MHz – 2480MHz and has a maxim um power of
0.00222W.
®
Bluetooth Specification
Description
Operating
Specification
Note
(2400 ... 2483,5) MHz
ISM Band
frequency range
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®
Bluetooth Specification
Description
Range
Specification
Note
Class 2, range up to 10 meters in an open field
Lower guard band
2 MHz
Upper guard band
3,5 MHz
Carrier frequency
2402 MHz ... 2480 MHz
f = 2402 + k,
k = 0...78
Modulation method
GFSK (1 Mbps)
P/4 DQPSK (2Mbps)
Hopping
1600 hops/s, 1 MHz channel space
Asynchronous, 723.2 kbps / 57.6 kbps
GFSK:
Synchronous: 433.9 kbps / 433.9 kbps
Maximum data rate
P/4
Asynchronous, 1448.5 kbps / 115.2 kbps
DQPSK:
Synchronous: 869.7 kbps / 869.7 kbps
8DQPSK:
Asynchronous, 2178.1 kbps / 177.2 kbps
Synchronous: 1306.9 kbps / 1306.9 kbps
Receiving signal
range
Receiver IF
frequency
-82 to -20 dBm
Center
frequency
1.5 MHz
Min
-11 ... -9 dBm
Transmission
power
Max
+14 ... +18 dBm
Compliance
Bluetooth specification, version 2.0 + EDR
Certification/
Compliance
FCC: Part 15, FCC ID QOQWT12
RSS210
13.1.6
Typical
condition
22mW em ission designation 1M21G2D
®
Industry Canada license 5123A-BGTWT12E
Glucometer
Batteries:
The GlucoTel meter requires 2 * AAA Batteries
(rechargeable batteries should not be used in the
GlucoTel meter).
Operating Temperature Range:
0 to +40 C. (32F to 104F)
Storage Tem perature Range:
-20 to +55 C. (-4F to 131F)
Accuracy:
±5.6%
Operating Humidity Range:
20% - 80% RH (relative hum idity),
Storage Humidity Range:
10% - 90% RH (relative hum idity).
Measuring Range:
20 to 525 mg/dl or 1.1 to 29.2 mmol/l
Transmission range:
3m in an open field when held by the user
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Automatic Switch On:
Upon insertion of test strip
Automatic Switch Off:
The GlucoTel meter turns off autom atically after 60
seconds and when the test strip is rem oved.
Size:
140 x 30 x 18 mm
Weight:
65g (including batteries).
The glucometer is provided by BodyTel Inc. of Germ any. Its specifications are detailed in its
user m anual which is provided on the CD-ROM with this m anual.
RDT recomm ends that the batteries are replaced annually when used in a commercial airlin e
application (once a week). Higher levels of usage (e.g. in a training departm ent) may requir e
the batteries to be changed more often.
®
The glucometer uses the sam e Bluegiga WT12A Bluetooth module that is detailed in section
13.1.5.
13.1.7
Environmental Specifications
Altitude:
13.1.7.1
0-4500m (0-15000ft)
(can be used at higher physical altitudes provided the
local atmosphere is no higher than 4500m, e.g. in a
pressurised aircraft cabin)
Relative humidity:
15%-95% (non-condensing)
Operating temperature range:
0ºC to 40ºC
Storage tem perature range:
-20ºC to +60ºC
NOTE:
Note that the IP sealing has a warranty of 1 year.
NOTE:
IPX6 and MIL810F tests are lab tests and not normal condition. The unit
remains intact and functional after tests but rough handling m ay degrade
perform ance specification i.e. if you hit it with steel ball then IP sealing around
the case may degrade, if you drop it from 1.2m then IP sealing m ay degrade
and a drop tests may dam age peripherals. Drop test perform ance
specifications relate to a standalone device with no cables connected.
Environmental Performance and Certification
Temperature & Altitude :
Category:
Test Standard,
A1
Temperature, RTCA/DO-160E Section 4, Para 4.5.1,
4.5.2 and 4.5.3
Test Standard, Altitude,
Temperature:
RTCA/DO-160E Section 4, Para 4.6.1 and 4.6.2
Operating: 0°C to +40°C Storage: -20°C to +60°C
Short Term High: +40°C
Altitude:
Storage:
Rapid Decompression:
Operating: Sea Level to 15,000 ft
Sea Level to 15,000 ft
10,000 ft to 55,000 ft in 10 seconds
Temperature Variation:
Test Standard:
Rate of Variation:
RTCA/DO160E Section 5 Cat C
2°C per minute.
Humidity:
Test Standard:
Storage:
RTCA/DO-160E Section 6 Cat A
15 to 95% RH Non-condensing (tested for 48 hours
at 38-50C)
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Operating:
15 to 95% RH Non-condensing (tested at the end of
the storage cycle)
Operational Shocks & Crash Safety:
Test Standard:
Operational Shock:
RTCA/DO-160E Section 7 Cat B
Para 7.2 (6g for 11ms saw-tooth wave, repeated 3
times in all axis).
20g in all directions (s ustained and impulse).
Crash Safety:
Vibration:
Test Standard:
Jet aircraft test
RTCA/DO-160E Section 8 Para 8.5.2
Procedure: Curve B3, 3hrs per axis (repeated for all
axis) –
10 Hz to 31 Hz at 0.02 g2/Hz Falling to 0.002 g2/Hz
at 100 Hz 100 Hz to 500 Hz at 0.002 g2/Hz Falling to
0.00013 g2/Hz at 2000 Hz
Helicopter test
Procedure: Curve F, 0.5hrs per axis (repeated for all
axis) –
5 Hz to 40 Hz at a ram p rate of +3 dB/Oct to a level
of 0.05 g2/Hz at 40 Hz 40 Hz to 200 Hz at 0.05 g2/Hz
Ramping from 200 Hz to 300 Hz at a ramp rate of -12
dB/Oct
Procedure: Curve F1, 3.5hrs per axis (repeated for all
axis) –
5 Hz to 40 Hz at a ram p rate of +3 dB/Oct to a level
of 0.10 g2/Hz at 40 Hz 40 Hz to 200 Hz at 0.10 g2/Hz
Ramping from 200 Hz to 300 Hz at a ramp rate of -12
dB/Oct
Explosion Proofness:
Not tested. Not to be used in the presence or explosive gasses or vapours.
Water Proofness:
Not tested to RTCA/DO160E Section 10.
Commercial qualification:
IPX6 (high pressure hose) – whole device
IPX4 (hoop) – capnom eter
IPXX (no classification) – glucom eter, thermom eter,
power supply, battery charger, headset
Fluids Susceptibility:
Not applicable. The product is for use in the cabin only.
Sand & Dust:
Not applicable. The product is for use in the cabin only.
Fungus Resistance:
Not applicable. The product is for use in the cabin only.
Salt Spray:
Not applicable. The product is for use in the cabin only.
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Magnetic Effect:
Not applicable. The product is for use in the cabin only.
Power Input:
Not tested to RTCA/DO160E Section 16.
Commercial qualification:
EN61000-3-2:2006 Mains harm onics
EN61000-3-3:1995 inc A1:2001 & A2:2005 Mains
flicker
EN61000-4-11:2004 voltage dips and interruptions
Voltage Spike :
Not tested to RTCA/DO160E Section 17.
Commercial qualification:
EN61000-4-4:2004 Fast transient bursts
Audio Frequency Conducted Susceptibility – Power inputs:
Not tested to RTCA/DO160E Section 18.
Commercial qualification:
EN61000-4-5:2006 Surges
Induced Signal Susceptibility:
Not tested to RTCA/DO160E Section 19.
Commercial qualification:
EN61000-4-6:1996 inc A1:2001 Conducted RF field
Radio Frequency Susceptibility (Radiated & Conducted):
Not tested to RTCA/DO160E Section 20.
Commercial qualification:
EN61000-4-3:2002 Radiated RF Interference
Emission of Radio Frequency Energy:
Test Standard:
RTCA/DO160E Section 21 Cat M.
Lightning Induced Transient Susceptibility:
Not applicable. The product is for use in the cabin only.
Lightning Direct Effects:
Not applicable. The product is for use in the cabin only.
Icing:
Not applicable. The product is for use in the cabin only.
ESD:
Not tested to RTCA/DO160E Section 25.
Commercial qualification:
EN61000-4-2:1995 inc A1:1999 & A2:2001 ESD
Fire and Smoke Hazards:
Main case material:
Glass reinforc ed nylon PA66+35%GF.
Flam e:
UL94V-0
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13.1.8
User/Operator Manual
Overm ould material:
TPE.
Flam e:
N/A
Miscellaneous Features and Specifications
Tempus IC dimensions
13.1.8.1
289mm wide x 203mm high x 101mm deep.
Rechargeable battery
Battery life
At least 6 hours running in normal use.
Nominal voltage
7.4V
Charging voltage
8.4V ±1%
Nominal capacity
7.8Ah
Weight
0.42kg nominal
Shelf life
Approxim ately 70% remaining after 1 year (before the
charge indicator light turns to Am ber)
Battery shelf life and run times are based on a new, fully charged battery stored in normal room ambient conditions. Run time is based
on RDT’s model of typical device usage in an incident.
13.1.8.2
Battery Charger
Mains input voltage
50-60Hz
Input current
0.9A max (at 100V apx)
Output voltage
8.4V dc
Output current
<2.73A
Charge time (from empty)
6 hours
NOTE:
13.1.8.3
Only the RDT Battery Charger pn 01-1012 can be used with the Tempus IC.
Mains Power Supply
Mains input voltage
100 - 240V
Frequency
50-60Hz
Input current
1.5A - 0.55A
Output voltage
12V dc
Output current
NOTE:
13.1.8.4
100-240V
Frequency
5A
Only the Cincon Electronics TR60M12 as supplied by RDT can be used with
the Tempus IC.
GPS
Antenna
Integral
Channels
20 satellites simultaneously
Sensitivity
Up to -159dBm
Accuracy
±30m (±2.5km with <6 satellites – labelled as
“Approxim ate Fix”
13.1.9
Communications
13.1.9.1
Transmission rates
ECG data and digital pictures take an appreciable amount of time to send to the Response
Centre, approxim ate times are as follows:
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
12 lead ECG – 2-3 minutes

Digital photographs – 2-3 m inutes.
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 m ay vary depending on the quality of
the connection.
13.1.9.2
WiFi Specification
The WiFi technology used by the Tempus operates using IEEE 802.11b and 802.11g standard.
It operates in the Industrial, Scientific and Medical (ISM) band between 2.412GHz and
2.484Hz.
The WiFi technology has the following features:
WiFi Spe cification
The WiFi module has the following specifications:
SKU #
North Am erica WL6231-1123
Transmit Power
CCK: 12 dBm typical
International WL6233-1125
OFDM: 9 dBm typical
63mW em ission designation 11M5F9W to
spec RSS210
Indoor Range
~ 300 feet (typical office environment)
Data Rate:
802.11a 54 Mbps OFDM: 9 dBm +1/-1.5 dBm
802.11g 54 Mbps OFDM: 11 dBm +1/-1.5
dBm
802.11 b 11 Mbps CCK: 15 dBm +1/-1.5 dBm
North America: 2.412-2.462 GHz, channels
1-11
Frequency Range:
Europe ETSI: 2.412-2.472 GHz, channels 113
Japan: 2.412-2.484 GHz, channels 1-14
Security Encryption/Authentication
Hard ware Support:
13.1.9.3
WEP 64/128, WPA (TKIP/AES), WPA2
(TKIP/AES)
Bluetooth® Specification
®
Bluetooth Specification
Description
Operating
Specification
Note
(2400 ... 2483,5) MHz
ISM Band
frequency range
Range
Class 1, range up to 100 m eters in an open field
Lower guard band
2 MHz
Upper guard band
3,5 MHz
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®
Bluetooth Specification
Description
Specification
Note
Carrier frequency
2402 MHz ... 2480 MHz
f = 2402 + k,
k = 0...78
Modulation method
GFSK (1 Mbps)
P/4 DQPSK (2Mbps)
Hopping
1600 hops/s, 1 MHz channel space
Asynchronous, 723.2 kbps / 57.6 kbps
GFSK:
Synchronous: 433.9 kbps / 433.9 kbps
Asynchronous, 1448.5 kbps / 115.2
kbps
P/4
Maximum data rate
DQPSK:
Synchronous: 869.7 kbps / 869.7 kbps
Asynchronous, 2178.1 kbps / 177.2
kbps
8DQPSK:
Synchronous: 1306.9 kbps / 1306.9
kbps
Receiving signal
range
Receiver IF
frequency
Transmission
power
13.1.9.4
-82 to -20 dBm
Typical
condition
Center
frequency
1.5 MHz
Min
-11 ... -9 dBm
Max
+14 ... +18 dBm
RSS210
22mW em ission designation 1M21G2D
RF input
impedance
50
Compliance
Bluetooth specification, version 2.0 + EDR
®
Bluetooth® Headset Specification
®
The Tempus IC uses the Bluetrek G3 wireless headset. This is unm odified by RDT and is
provided under FCC ID QITBTG3 under FCC part 15C and under AusCom approval N1342
It operates in the frequency bands 2402MHz – 2480MHz and has a maxim um power of
0.00297W.
Wireless Performance Specifications
Description
Transmitter
Receiver
Operating frequency range
2402 - 2480 MHz
2402 - 2480 MHz
FHSS modulation
FHSS modulation
79
79
Channel separation
1MHz
1MHz
Type of antenna
Ceramic type
Antenna gain
(dBi) 0
Power level
Fixed
Type of modulation
Number of channels
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General Spe cifications
Description
®
Bluetooth type
V1.2 class 2
Range
10m m ax in an open field
Weight
12g
Size
67.5mm x 19.5mm
Talk tim e
Up to 13 hours*
Stand by time
Up to 400 hours*
*Based on the m anufacturer’s specification – can be 12.5 hours in HV3, 10 hours in HV2 and
5.3 hours in HV1 modes (HV level set by host device).
Battery shelf life and run times are based on a new, fully charged battery.
13.1.9.5
FCC & Industry Canada Notes on Wireless Communications
FCC ID: ROSTEMPUSIC-1
CAUTION:
Do not disassemble the device. There are no user-s erviceable parts inside.
Refer servicing to the manufacturer. Changes or m odifications not
expressly approved by RDT could void the user’s authority to operate the
equipment.
This equipm ent has been tested and found to comply with the limits for a Class B digital
device, purs uant to part 15 of the FCC rules and Industry Canada Radio Standard RSS 210.
These limits are designed to provide reasonable protection against harmful interference in a
residential installation.
This equipm ent generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation.
If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipm ent off and on, the user is encouraged to try to correct
the interference by one or more of the following m easures:
 Reorient or relocate the receiving antenna.
 Increase the separation between the equipm ent and receiver.
 Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
 Consult the dealer or an experienced radio/TV technician for help.
Operation is subject to the following two conditions:
 This device m ay not cause interference and
 This device m ust accept any interference, including interference that m ay cause
undesired operation of the device.
This equipm ent is also ETS 300 328, ETS 300 826, ETS 300 328-2, ETS EN301 489-1 and
ETS EN301 489-17 com pliant. These lim its are designed to provide reasonable protection
against harmful interference when the equipment is operated in a comm ercial environment.
The user m ay find the following booklet helpful: How to Identify and Resolve Radio-TV
Interference Problems. This booklet is available from U.S. Government Printing Office,
Washington, D.C. 20402.
Radio Frequency Interference Require ments – Canada
This Class B digital apparatus m eets the requirements of the Canadian Interference-Causing
Equipm ent Regulations.
13.1.9.6
Ethernet Specification
The Ethernet connection has the following specifications:
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13.1.9.7
User/Operator Manual

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 diam eter: at least 100m
Modem Specification
The Tempus IC contains two m odems which can be connected to a telephone network via the
RJ-45 connector. The modems are used either:

together over 2k4baud channels (typically Inmarsat classic satcoms for aero or m aritim e
applications where one modem is used to transmit data and the other voice);

or in landline applications where the a single modem is used to transmit voice and data
simultaneously.
The modems support the following data protocols: V.92; V.90, V.34, V.32bis, V.32, V.22bis,
V.22, V.23, V.21, Bell 212A & Bell 103. Error correction uses V.42 (LAP-M or MNP 2–4).
13.1.9.8
USB-Serial Adaptor Specification
The Tempus IC’s USB connector may be used with the USB-Serial Adaptor cable (pn 01-1022)
in order to provide data or voice and data communications over serial (RS-232) channels such
as Iridium (data only) or Sat B (voice and data).
Data speeds of from 9600baud.
13.1.9.9
GSM & GPRS Specification
The Cell Phone (GSM) technology used by the Tempus has the following specifications:
GSM/GPRS Specification
Operating
Parameter
Min
Max
Unit
frequency range
Frequency Range
GSM 850
824
849
MHz
Uplink (MS →
BTS)
E-GSM 900
880
915
MHz
GSM 1800
1710
1785
MHz
GSM 1900
1850
1910
MHz
Frequency Range
GSM 850
869
894
MHz
Downlink (BTS →
MS)
E-GSM 900
925
960
MHz
GSM 1800
1805
1880
MHz
GSM 1900
1930
1990
MHz
RF power
Parameter
RF power @ARP
with 50ゴ Load
Number of carriers
Min
Max
Unit
GSM 850
31
35
dBm
E-GSM 900
31
35
dBm
GSM 1800
28
32
dBm
GSM 1900
28
32
dBm
Band
Channels
GSM 850
124
E-GSM 900
174
GSM 1800
374
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Duplex Spacing
Carrier Spacing
Multiplex, Duplex
Time Slots Per TDMA
Fame
Fram e duration
Time Slot duration
Modulation
Receiver input
sensitivity @ ARP
BER Class II < 2.4%
(static input level)
GSM 1900
299
Band
Typical
GSM 850
45 MHz
E-GSM 900
45 MHz
GSM 1800
95 MHz
GSM 1900
80 MHz
200 KHz
TDMA / FDMA, FDD
4.615mS
577ųS
GMSK
Parameter
Typ
Unit
-107
-107
-107
GSM 850
-102
E-GSM 900
-102
GSM 1800
-102
GSM 1900
13.1.10
Min
-102
dBm
dBm
dBm
dBm
-107
Note:
Users are reminded that the cell phone is only for use outside north
Am erica. Use of the GSM/GPRS radio in north America is subject to a
planned regulatory submission
Note:
This device contains GSM 900 MHz and GSM 1800MHz functions that are
not operational in U.S. Territories.
Tempus IC Device Classification
The system is classified according to the requirements of EN60601-1:1990 inc. A13:1996, the
standard for Medical Electrical Equipm ent, Part 1, General Requirements for Safety, Clause 5
as:
5.1
The Tempus IC is Internally (battery) powered – when powered by an external power
supply it is class II as defined by the classification labelled on the power supply
specified and supplied by RDT. The therm ometer is internally (battery) powered.
Applied parts type CF defibrillator proof, therm ometer classified as BF, glucometer is
not classified as it is an IVD rather than a m edical device.
The Tempus IC is rated IPX6, protected against rainfall according to IEC529. The
capnometer is rated IPX4. All other parts are rated IPXX.
No parts supplied sterile or suitable for/requiring sterilising
Equipm ent not suitable for use in the presence of a flamm able anaesthetic mixture
with air or with oxygen or nitrous oxide
Suitable for continuous use
5.2
5.3
5.4
5.5
5.6
Note that the classification of the thermometer is different to those of the Tempus IC.
The therm ometer is:

rated type BF,

not protected against the effects of a cardiac defibrillator discharge,

internally powered only (no m eans of connecting external power),

not supplied sterile or has any parts which are required to be sterilised,
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
not suitable for use in the presence of a flamm able anaesthetic mixture with air or with
oxygen or nitrous oxide,
is intended for intermittent use (it measures discrete readings rather than being used
continuously) – the product will automatically power off after a minute if it is not used.

Similarly it should be noted that the glucometer is not classified under IEC60601-1. This is
because the glucometer is classified as an IVD (invitro-diagnostic device) rather than a patient
applied medical device.
13.1.11
Standards Compliance
The Tempus IC complies with the applicable parts of the following standards:
Standard
Title
nd
IEC 60601-1 2
1988
edition:
Medical electrical equipm ent: General requirements for safety (as
amended)
Am endment A1:1993,
A11:1993, A12:1993,
A1:1995, A13:1996
IEC 60601-1-1:2000 –
reference standard only
Medical electrical equipm ent -- Part 1-1: General requirements for
safety - Collateral standard: Safety requirements for m edical
electrical systems
IEC 60601-1-2:2005
Medical electrical equipm ent -- Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility Requirements and tests
IEC 60601-1-4:1996
Medical electrical equipm ent -- Part 1-4: General requirements for
safety - Collateral standard: Programmable electrical m edical
systems (as amended)
Am endment A1:1999
IEC 60601-1-6:2004
Medical electrical equipm ent -- Part 1-1: General requirements for
safety - Collateral standard: Usability
IEC 60601-2-25:1993
Medical electrical equipm ent -- Part 2-25: Particular requirements
for the safety of electrocardiographs
Am endment A1:1999
IEC 60601-2-30:1999
Medical electrical equipm ent -- Part 2-30: Particular requirements
for the safety, including essential perform ance, of automatic
cycling non-invasive blood pressure m onitoring equipm ent
IEC 60601-2-49:2006
Medical electrical equipm ent -- Part 2-49: Particular requirements
for the safety of m ultifunction patient monitoring equipment
ISO 21647:2004
Medical electrical equipm ent - Particular requirem ents for the basic
safety and essential performance of respiratory gas monitors (as
amended)
ISO 21647:2004/AC:2006
ISO 9919:2005
Medical electrical equipm ent - Particular requirem ents for the basic
safety and essential performance of pulse oxim eter equipment for
medical use
ISO 14971:2007
Medical devices - Application of risk m anagement to medical
devices
EN 60529:1992
Specification for degrees of protection provided by enclosures (IP
code)
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Standard
Title
EN 980:2008
Graphical symbols for use in the labelling of medical devices
EN 1041:1998
Information supplied by the manufacturer of medical devices
ISO 10993-1: 2003
Biological evaluation of medical devices - Part 1: Evaluation and
testing
RTCA/DO160E
Environmental conditions and test procedures for airborne
equipment
UL 1642 Issue 4
Standard for lithium batteries
13.1.11.1
EMC Information
The following tables provide inform ation required to be provided under IEC60601-1-2.
Cable Length of the Sensors and the Acce ssories
RDT Part
Number
Cable
Length
(typ.)
Tested
Length
Ethernet cable
01-1021
2.1m
2.1m
SpO2 sensor
01-1008
1.5m
1.5m
ECG harness
01-1010
1.5m
1.5m
Capnom eter
01-1005
0.5m
0.5m
Wired headset
01-1019
1.2m
1.2m
Mains Power supply
01-1017
0.45m
0.45m
Mains lead
01-1015
2m
2m
WARNING:
The use of longer cable lengths m ay cause an increased emission or a
reduced interference resistance. The use of other sensors or cables except the
ones mentioned above is not allowed.
Manufacturer's Declaration - Electromagnetic Emissions (Tab. 201 according to DIN EN
60601-1-2)
The Tempus IC is intended for use in an electromagnetic environment as described below. The
customer or user of the device should ensure that the device is used in such an environm ent.
Emission
Measure ments
HF em issions acc. to
CISPR11
Compliance
Electromagnetic Environment
Group 2
The Tempus IC m ust emit RF energy in order
to perform its function. Nearby electronic
devices may be affected.
Note that the Tempus IC can be configured
for not to emit RF energy in which case it will
be group 1 and will not be likely to cause any
interference in nearby electronic equipm ent.
HF em issions acc. to
CISPR11
Class B
The Tempus IC is intended for use in all
facilities including living quarters and such
ones which are connected directly to a public
power supply that supplies also buildings
used for living purposes.
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Emission
Measure ments
Compliance
Emission of overtones
acc. to IEC61000-3-2
Class A
Emission of voltage
fluctuation/flicker acc.
to IEC61000-3-3
Complies
Electromagnetic Environment
Manufacturer's Declaration - Electromagnetic Emissions (Tab. 202 according to DIN EN
60601-1-2)
The Tempus IC is intended for use in an electromagnetic environment as described below. The
customer or user of the device should ensure that the device is used in such an environm ent.
Electromagnetic
Environment Guidelines
Interference
Resistance Test
IEC 60601 Test
Level
Compliance Level
Electrostatic
discharge (ESD) acc.
to IEC 61000-4-2
± 6 kV contact
discharge
± 8 kV air discharge
± 6 kV contact
discharge
± 8 kV air discharge
Floors should be of
wood, concrete or
ceramic tiles. If the
floor is tiled with
synthetic m aterial the
relative air humidity
must have 30 % at
least.
Fast transient electric
disturbances / bursts
acc. to IEC 61000-44
± 2 kV for power
lines
± 1 kV for input and
output lines
± 1 kV for input and
output lines
The quality of the
supply voltage should
conform to a typical
business or clinic
environment.
Surge voltage
acc. to IEC 6100-4-5
± 1 kV norm al m ode
voltage
± 2 kV common
mode voltage
± 1 kV norm al m ode
voltage
± 2 kV common
mode voltage
Mains power should be
that of a typical
hospital or commercial
environment.
Voltage drops, short
interruptions and
variations in supply
voltage acc. to
IEC 61000-4-11
< 5 % UT (>95 %
break of UT for 0,5
period
40 % UT (60% break
of UT ) for 5 periods
70 % UT (30% break
of UT ) for 25 periods
< 5 % UT (>95 %
break of UT for 5
seconds
< 5 % UT (>95 %
break of UT for 0,5
period
40 % UT (60% break
of UT ) for 5 periods
70 % UT (30% break
of UT ) for 25 periods
< 5 % UT (>95 %
break of UT for 5
seconds
Mains power should be
that of a typical
hospital or commercial
environment. If the
user of the Tempus IC
requires continued
operation during power
interruptions then the
battery m ay be used
for periods up to 6
hours or a UPS may
be used.
Magnetic field at the
supply frequency
(50/60 Hz) acc. to
IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at the
supply frequency
should conform to the
typical values as they
occur in the business
or clinic environment.
NOTE UT is the AC mains voltage before the use of testing levels
Manufacturer's Declaration - Electromagnetic Interference Resistance (Tab. 204
according to DIN EN 60601-1-2)
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The Tempus IC is intended for use in an electromagnetic environment as described below. The
customer or user of the device should ensure that the device is used in such an environm ent.
Interference
Resistance Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment –
Guidelines
Conducted RF
disturbances acc.
toIEC61000-4-6
3 Vrms
150 KHz to
80 Mhz
3Vrms
Portable and mobile RF
communications equipm ent should
be used no closer to the device
including the cables than it is
recommended by the equation for
the frequency.
3 V/m
80 MHz to 2,5
GHz
3Vrms
Recommended safety distance:
Radiated RF
disturbances acc.
to IEC61000-4-3
d = 1.2√P
d = 1.2√P for 80MHz to 800 MHz
d = 2.3√P for 800 MHz to 2,5 GHz
P is the nominal power of the
transmitter in watt (W) according to
the specifications of the transmitter
manufacturer; d is the
recommended safety distance in
meters (m).
The field strength of stationary
transmitters should be lower than
the Com pliance level for all
frequencies according to a testing
on location.
Disturbances are possible near
devices with the following symbol:
NOTE 1: For 80 Hz and 800 MHz the higher frequency range is valid.
NOTE 2: These guidelines may not be applicable for all cases. The propagation of
electrom agnetic values is influenced by absorptions and reflections of buildings, objects and
people.
a) The field strength of stationary transmitters such as fixed parts of cellular phones and m obile
radio sets, amateur radio stations, AM and FM radio and television cannot be determ ined
exactly in theory. To detect the electrom agnetic environment in regard to stationary
transmitters a study of the location should be considered. If the measured field strength at the
location where the device is being used exceeds the Com pliance level above the device should
be watched to verify the proper functions. If unusual features are watched additional actions
might be necessary such as a m odified orientation or another location of the device.
b) For the frequency range of 150 kHz to 80 MHz the field strength should be lower than 10
V/m.
Recommended Safety Distances between portable and mobile RF Telecommunication
Devices and the TEMPUS IC (Tab. 206 according to DIN EN 60601-1-2)
The TEMPUS IC is intended for use in an electrom agnetic environment with controlled RF
disturbances. The user of the device can help to avoid electromagnetic disturbances by
keeping the minim um distance between portable and mobile telecommunication devices
(transmitters) and the device - depending on the output power of the telecommunication
devices as described below.
Safety Distance Depending on the Frequency in m
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Safety Distance Depending on the Frequency in m
Nominal power of the
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1.2√P
d = 1.2√P
d = 2.6√P
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters with a maxim um nominal power not mentioned above: To detect the
recommended safety distance use the equitation in the corresponding column. P is the
maximum nominal power of the transmitter in watt (W) according to the specifications of the
transmitter manufacturer.
NOTE 1: For 80 Hz and 800 MHz the higher frequency range is valid.
NOTE 2: These guidelines may not be applicable for all cases. The propagation of
electrom agnetic values is influenced by absorptions and reflections of buildings, objects and
people.
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Symbols Used on the Tempus IC
The following sym bols are used on the Tem pus IC:
Symbol
Description
Defibrillation proof type CF applied part,
Type BF applied part. The therm ometer is not proof against the
effects of a cardiac defibrillator discharge.
Attention, consult accompanying documents
Battery Charge indicator – flashes green when the battery is on
charge
Battery power level
System power on/off (push/push)
Date of manufacture, where the year that the item was
manufactured is represented by the year and then the month
e.g. 2002 06 is June 2002.
YYYY - MM
Single use device only, discard item after use
IPX6
The device is proof against a hose according to IEC529
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Symbol
Description
The device has been declared by the manufacturer to be in
accordance with the requirem ents of the European Union
Medical Devices Directive 93/42/EEC as transposed by UK
national legislation.
YYYY - MM
LOT YYYY - MM
Shelf life, where the tim e that the unit must be used by is
represented by the year and then the month e.g. 2004 06 is
June 2004.
Where the year that the item was m anufactured as a part of a
larger batch is represented by the year and then the month e.g.
2002 06 is June 2002.
This product should not be discarded as general waste and must
be disposed of as electrical and electronic waste.
Communications connections
WiFi connection mode to response centre
®
Bluetooth connection to medical m odules
Battery Connection – to indicate positive term inal polarity
Global Positioning System (GPS)
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Symbol
Description
Global System for Mobile (GSM) comm unications
Headset connector
Power Status (green indicates mains power is connected)
Camera Backlight
Device contains wireless transmitters
DC connector
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User/Operator Manual
End User License Agreement
This license covers RDT’s Tem pus IC software.
Warning: The software contained herein is protected by copyright law and international treaties.
Unauthorized reproduction, distribution or reverse engineering of this program , or any portion of
it, m ay result in severe civil and criminal penalties, and will be prosecuted to the m aximum
extent possible under the law.
You acknowledge that you will read and adhere to the user m anual and ensure that users
receive proper training from RDT or an appropriately trained individual. You also acknowledge
that you will maintain the software by installing new software updates supplied by RDT within 5
working days of receiving or being notified of them.
License:
You may transfer the program and license to another party if the party agrees to accept the
terms and conditions of this agreem ent. You will not share the program with other parties and
will keep the program and details of its functions confidential. You will ensure that access to
the software and use of it will be restricted to properly trained and authorized personnel only.
You will not try to copy or reverse engineer the software.
The Tempus IC operates over third-party communications links, such as telephone lines, GSM
or satellite links and the Internet. RDT does not accept liability for the failure of these links to
reliably transmit inform ation from RDT’s products. Users are reminded that it is their
responsibility to ensure that GSM network and other communications contracts are maintained
and suitably setup and configured for the areas in which they need to be used.
In order to function correctly Tem pus IC needs to operate over a comm unications link such as
satellite communications, GSM or a telephone line and other types of links. It is your
responsibility to m aintain these comm unications links. Such links may have security or other
measures im plemented on them such as firewalls. It is your responsibility to ensure that any
such firewalls or other elements of the communication link are configured correctly to allow data
from Tempus IC to communicate over said link. RDT does not accept any responsibility for
failure to transmit data or to transmit data reliably over such links if they have not been
configured correctly. Support on configuring such links can be obtained from RDT upon
request.
Neither the Tempus IC or RDT are a "covered entity" under the Health Insurance Portability
and Accountability Act of 1996 and the regulations prom ulgated thereunder ("HIPAA"). As a
result, HIPAA does not apply to the transmission of health inform ation by RDT or Tem pus IC to
any third party.
The software gives users the ability to share and transmit medical data with third parties. Such
activities are entirely the responsibility of the user.
RDT owns all proprietary rights to the Tempus IC. RDT gives you a personal, revocable, nonassignable, and non-exclusive license to use the Tempus IC.
Limited Warranty and Rem edies:
In no event shall RDT or its distributors or agents, be liable for any damages resulting from loss
of data, loss of revenue or for any incidental or consequential damages incurred arising out of
or relating to the use of this software product. Som e jurisdictions do not allow the exclusion of
implied warranties, so the above exclusion may not apply to you. This warranty gives you
specific legal rights and you may have other rights that vary from region to region.
RDT’s Terms and Conditions apply.
RDT and its distributors m ake no representations with respect to the merchantability or fitness
of the Tempus IC software and the product is supplied "as is", without any warranty of any kind.
Further, RDT reserves the right to revise its publications and program(s) without obligation to
notify customer of such a revision.
You acknowledge that you have read this agreement, understood it, and agree to be bound by
its terms and conditions.
Failure to enforce any provision will not constitute a waiver of that provision. If any provision is
found unenforceable, it and any related provisions will be interpreted to best accom plish the
unenforc eable provision's essential purpose.
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Tempus IC
User/Operator Manual
This agreement is governed by UK law. The exclusive venue for any dispute relating to this
agreem ent is London UK. You and RDT consent to the pers onal jurisdiction of these courts.
Nothing in this agreem ent limits either party's ability to seek equitable relief.
Pocket Medic
This license covers QRS Pocket Medic software.
Warning: The software contained herein is protected by copyright law and
international treaties. Unauthorized reproduction, distribution or reverse engineering
of this program, or any portion of it, may result in severe civil and criminal penalties,
and will be prosecuted to the maximum extent possible under the law.
License:
· You may use this program on a single computer.
· You may make a back up copy of this software in support of your use of this
software.
· You may transfer the program and license to another party if the party agrees to
accept the terms and conditions of this agreement. If you transfer the software you
must turn over all copies of the software to the same party or destroy any copies not
transferred.
Limited Warranty and Remedies:
In no event shall QRS Diagnostic, LLC or the distributors of "Pocket Medic", be liable
for any damages resulting from loss of data, loss of revenue or for any incidental or
consequential damages incurred arising out of or relating to the use of this software
product. Some jurisdictions do not allow the exclusion of implied warranties, so the
above exclusion may not apply to you. This warranty gives you specific legal rights
and you may have other rights that vary from region to region.
QRS Diagnostic, LLC and its distributors MAKE NO REPRESENTATIONS with
respect to the merchantability or fitness of "Pocket Medic" and the product is sold "as
is", without any warranty of any kind. The only exception is the 60-day warranty
extended for replacement of defective disks. Further, QRS Diagnostic, LLC, reserves
the right to revise its publications and program(s) without obligation to notify customer
of such a revision.
You acknowledge that you have read this agreement, understood it, and agree to be
bound by its terms and conditions; you further agree that it is the complete and
exclusive statement of the agreement between us which supercedes any proposal or
prior agreement, oral or written, and any other communications between us relating to
the subject matter of this agreement.
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Tempus IC
16
User/Operator Manual
Change History
Page/Section
Change
Date/Issue
N/A
First release
00
5.2.4
Added section on GSM/ DPRS display
01
8.4
Section added on using the thermometer
01
8.5
Section added on using the glucometer
01
8.6
Information added on transmitting moving video
01
9.1.1
Section added covering cleaning of the therm ometer
01
10.2.5
Added section on batteries (headset, glucom eter and therm ometer)
01
10.3.1
Section added on thermom eter errors
01
10.3.2
Section added on glucometer errors
01
11
Added glucometer calibration kit as an accessory
01
13.1.5
Specification section added for the therm ometer.
01
13.1.6
Specification section added for the glucometer.
01
13.1.7.1
Environm ental testing section added
01
13.1.9
Expanded details of communications specifications
01
13.1.10
Classification details updated to cover the therm ometer and glucom eter
01
14
Added BF sym bol for the therm ometer
01
15
Added EULA to section 15, m oved change history to section 16
02
31
Added Accessory Pouch
03
38
Added information to section 7.2.1.1.2 on getting information on how to
adjust the volum e of the wireless headset.
03
63
Added section 8.9 on GPS
03
83
Added Accessory Pouch
03
96
Added 13.1.8.4 for GPS specification
03
99
Updated WiFi specification
04
101
Updated FCC & IC numbers for Tem pus IC
04
102-103
Updated GSM specification
04
Page 114
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