Tempus Pro
User/Operator Manual
Part number 41-2001EN-00
Date of issue: 2019-07-03
This document contains legally protected information. All rights reserved. Copying in mechanical, electronic
and any other form without the written approval of the manufacturer is prohibited.
Copyright © 2013-2019
Remote Diagnostic Technologies Ltd.
Manufacturer’s address
RDT contact details
The Tempus Pro is designed and manufactured by:
Remote Diagnostic Technologies Limited
Pavilion C2
Ashwood Park
Ashwood Way
Basingstoke
Hampshire
RG23 8BG
UK
Tel: +44 (0) 1256 362 400
Fax: +44 (0) 1256 362 415
www.rdtltd.com
Australian TGA sponsor:
Philips Electronics Australia Ltd
65 Epping Road
North Ryde
NSW Australia 2113
0413
Tempus Pro User/Operator Manual - 41-2001EN-00
Table of Contents
1 Introduction 9
1.1 CE statement 10
1.2 FDA prescription statement 10
1.3 Proprietary notice 10
1.4 Use of this manual 11
1.5 Intended users 11
1.6 Features list 11
1.7 Patent and warranty 12
1.7.1 Patent claims 12
1.7.2 Limited warranty 12
1.7.3 Service support and returns 12
2 Warnings and cautions 13
2.1 Safety and note icons 13
2.2 EMC information 13
2.3 Indications for use 14
2.3.1 Contraindications 14
2.4 General warnings, cautions and notes 15
3 Introduction to the Tempus Pro 25
3.1 Overview of the Tempus Pro 26
3.2 Key features of the unit 26
3.2.1 Tempus Pro front 26
3.2.2 Tempus Pro base 26
3.2.3 Tempus Pro rear 27
3.2.4 Tempus Pro left side 28
3.2.5 Tempus Pro right side 29
3.3 Theory of operation 31
3.3.1 Pulse rate and oxygen saturation (SpO2) 31
3.3.2 Non-invasive blood pressure 32
3.3.3 Electrocardiograph (ECG) 32
3.3.4 Impedance pneumography 32
3.3.5 End tidal CO
3.3.6 Temperature 33
3.3.7 Invasive pressure 33
3.3.8 Controls and indicators 33
3.3.9 Summary Record of Care / Tactical Combat Casualty Care 34
3.3.10 Previous activity button 34
3.3.11 Trends 34
3.3.12 Data handover 34
3.3.13 Email 34
3.3.14 ePCR export 34
3.3.15 Communications 35
3.3.16 On-screen user instructions 36
(ETCO
2
) and respiration rate 32
2
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 3
Table of Contents
4 Setting up 37
4.1 Before deployment 37
4.2 Unpacking the Tempus Pro 38
4.3 Starting and stopping the Tempus Pro and selecting a patient 39
4.3.1 Switching on 39
4.3.2 Tactical mode (optional) 39
4.3.3 Setting the patient 41
4.3.4 Starting and stopping iAssist 41
4.3.5 Switching off 42
5 Using the Tempus Pro 43
5.1 Controlling the Tempus Pro 43
5.1.1 The touchscreen 43
5.1.2 Membrane buttons and LED indicators 45
5.1.3 Status bar 46
5.1.4 Status bar for communications 48
5.1.5 Instrument readings 49
5.2 Menus 50
5.2.1 The main menu 50
5.2.2 Printer and Headset menu 53
5.2.3 Power and clock settings 53
6 Taking medical readings 55
6.1 Electrocardiography (ECG) 55
6.1.1 Getting started 57
6.1.2 Monitoring ECG with a 3-lead cable 58
6.1.3 Monitoring ECG with a 4-lead cable 59
6.1.4 Monitoring ECG with a 5-lead cable 60
6.1.5 Monitoring ECG with a 12-lead cable 61
6.1.6 Performing a diagnostic ECG 63
6.1.7 ECG specifications 66
6.1.8 ECG settings 68
6.1.9 Detecting arrhythmias during ECG monitoring 70
6.1.10 Measuring ST elevation and QT interval (optional) 72
6.1.11 Monitoring respiration rate with ECG cable 74
6.1.12 Monitoring heart/pulse rate with no leads 77
6.2 Non-invasive blood pressure (NIBP) 78
6.2.1 Getting started 81
6.2.2 Taking readings 81
6.2.3 NIBP settings 83
6.3 Pulse oximetry 85
6.3.1 Getting started 95
6.3.2 Pleth variability index 95
6.3.3 Taking readings 96
6.3.4 Features 97
6.3.5 Pulse oximetry probes 98
6.3.6 Pulse oximeter settings 99
6.3.7 SpHb settings 102
6.4 Capnography 103
6.4.1 Getting started 105
6.4.2 Taking readings 106
6.4.3 Capnometer settings 107
6.5 Contact temperature 109
6.5.1 Getting started 109
6.5.2 Taking readings 109
6.5.3 Contact temperature settings 110
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 4
Table of Contents
6.6 Invasive pressure 112
6.6.1 Getting started 113
6.6.2 Taking readings 113
6.6.3 Invasive pressure settings 115
6.6.4 Configuring the transducer / channel 115
6.6.5 Zeroing transducers 117
6.6.6 Two channel USB invasive pressure module 119
7 Alarms 123
7.1 Audible alarm characteristics 125
7.2 Visual alarm characteristics 125
7.2.1 Alarm bar LEDs 126
7.2.2 Alarm status area 126
7.2.3 Alarm limits bar 127
7.2.4 Bottom status bar 128
7.3 Patient alarms 129
7.4 Technical alarms 132
7.5 Setting alarms 135
7.5.1 Default alarm settings 135
7.5.2 All alarms menu 137
7.6 Silencing or suspending alarms 141
7.7 Viewing and clearing alarms 143
7.8 Tactical mode warning 144
7.9 Testing alarms 145
8 Summary Record of Care 147
8.1 Event capture 147
8.1.1 General screen 147
8.1.2 Assessment, intervention, fluid and drug screens 148
8.1.3 Map/score screen 151
8.1.4 Automatic event capture 153
8.2 Events summary list 154
8.2.1 Summary screen 155
8.2.2 Waveform viewer 155
8.2.3 Updating an observation category marker 156
8.3 Trends 156
8.3.1 Trend graph 156
8.3.2 Trend table 157
9 Other features of the Tempus Pro 159
9.1 Data input and output 159
9.1.1 The Data Input and Output menu 159
9.1.2 Send patient data/report 160
9.1.3 Tempus to Tempus data handover 165
9.2 Display options 166
9.2.1 The Display menu 166
9.2.2 Display modes 168
9.2.3 High contrast mode 169
9.2.4 Waveform and lead selection 170
9.2.5 Brightness control 172
9.2.6 Locking the touchscreen 173
9.2.7 Power save feature 174
9.3 Patient information 174
9.3.1 The patient menu 174
9.3.2 Updating the TCCC card 175
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 5
Table of Contents
9.3.3 Admitting a new patient 179
9.3.4 Switching to a previous patient 181
9.3.5 Entering patient details 182
9.4 Digital camera 183
9.4.1 Annotation of digital pictures 184
9.5 GPS location 185
9.6 Connecting to an alternate location 186
9.6.1 Making the data connection 187
9.6.2 Fitting the headset and making the voice connection 188
9.6.3 Connection status indicators 191
9.6.4 Communications modes 192
9.6.5 Interacting with the Response Centre 194
9.6.6 Recording data off-line and transmitting on-line 195
9.7 iAssist processes 195
9.7.1 Monitoring ECG 197
9.7.2 Taking blood pressure measurements 197
9.7.3 Taking pulse oximetry measurements 197
9.7.4 Taking capnometry readings 197
9.7.5 Taking temperature readings 197
9.7.6 Using the camera 197
9.8 View installed features 198
9.9 Printer maintenance 198
9.9.1 External printer configuration 198
9.9.2 Internal printer configuration (optional) 198
9.9.3 Changing the paper roll (internal printer only) 199
9.9.4 Fitting the printer lid (internal printer only) 202
9.10 Managing Wi-Fi networks 204
10 After using the Tempus Pro 207
10.1 Inspecting the Tempus Pro 207
10.2 Cleaning the Tempus Pro 207
10.2.1 Cleaning the case of the Tempus Pro 207
10.2.2 Cleaning the display 208
10.2.3 Cleaning connectors 209
10.2.4 Cleaning the NIBP cuffs and hose 209
10.2.5 Cleaning the SpO2, ECG and invasive pressure cables 209
10.2.6 Cleaning the battery contacts 209
10.3 Disposal at end of life 209
10.3.1 Disposal of single use devices 210
11 Maintenance, servicing and troubleshooting 211
11.1 Tempus Pro battery 212
11.1.1 The battery 212
11.1.2 Removing the battery from the Tempus Pro 214
11.1.3 Charging the battery 215
11.2 Wireless headset battery 218
11.2.1 Charging the headset 218
11.2.2 General guidelines for safe use 219
11.2.3 Disposal of batteries 219
11.3 Daily checks 219
11.4 Weekly checks 220
11.5 Troubleshooting 220
12 Accessories list of the Tempus Pro 221
12.1 Parts list 221
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 6
Table of Contents
12.1.1 Temperature accessories 221
12.1.2 Invasive pressure accessories 221
12.1.3 Non-invasive blood pressure accessories 222
12.1.4 Masimo accessories 222
12.1.5 Masimo Rainbow field upgrades 223
12.1.6 Ultrasound accessories 223
12.1.7 Video laryngoscope accessories 224
12.1.8 Capnometer accessories 224
12.1.9 Electrocardiogram accessories 224
12.1.10 Power and charging accessories 226
12.1.11 Tempus Pro ReachBak real-time telemedicine accessories 226
12.1.12 Miscellaneous accessories 226
12.1.13 Anaesthetic gas monitoring accessories 227
12.1.14 Corsium Crew accessories 227
12.1.15 Manuals and software accessories 227
13 Configuring the Tempus Pro 229
13.1 Demonstration and training 229
14 Specifications and standards 231
14.1 Specifications 231
14.1.1 ECG monitoring 231
14.1.2 12-lead diagnostic ECG viewing and recording 232
14.1.3 Impedance pneumography (respiration) 233
14.1.4 ETCO2 sensor 234
14.1.5 Non-invasive blood pressure 234
14.1.6 Invasive pressure 235
14.1.7 Masimo pulse oximetry 235
14.1.8 Masimo Set rainbow 237
14.1.9 Contact temperature 238
14.2 Physical characteristics and environmental specifications 239
14.2.1 Environmental performance and certification 240
14.2.2 Use in high ambient temperatures 242
14.3 Miscellaneous features and specifications 243
14.3.1 Invasive pressure USB module 01-2017 (optional) 243
14.3.2 Rechargeable battery 244
14.3.3 Mains power supply 245
14.3.4 Battery charger 245
14.3.5 Vehicle power supply 246
14.3.6 GPS 246
14.3.7 Other features 246
14.4 Communications 247
14.4.1 i2i ReachBak communications 247
14.4.2 Ethernet specification 248
14.4.3 WiFi specification 248
14.4.4 Integral 2G and 3G cell phone specification 249
14.4.5 Bluetooth® specification 250
14.4.6 Bluetooth® headset specification 250
14.4.7 Communications security specification 250
14.4.8 FCC and Industry Canada compliance 251
14.5 Tempus Pro device classification 252
14.5.1 Standards compliance 252
14.6 EMC information 253
14.6.1 Cable length of the sensors and the accessories 253
14.6.2 Manufacturer's Declarations 254
14.6.3 Recommended safety distances 258
14.7 Factory default settings 258
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 7
Table of Contents
15 Symbols used on the Tempus Pro 260
15.1 Symbols used 260
16 End user license agreement 268
16.1 Tempus Pro EULA 268
16.2 Mocana EULA 269
16.3 MPEG4 EULA 270
16.4 Masimo® EULA 270
16.5 Firebird – Interbase Public License 271
16.6 Info-Zip License 271
16.7 OpenSSL License 271
16.8 US Government Devices – US Department of Defense (DoD) Notice and
Consent Banner 272
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 8
1 Introduction
This manual is for the Tempus Pro patient monitor.
All Tempus Pro monitors have a standard configuration that provides ECG monitoring, NIBP, pulse oximetry
(SpO
) and impedance respiration. Additional functions are available depending on Tempus Pro part
2
number:
00-1004-R: standard configuration with invasive pressure (2 channels), ETCO
(1 or 2 channels).
00-1007-R: standard configuration with invasive pressure (2 channels), ETCO
or 2 channels) and Bluetooth headset.
00-1024-R: standard configuration with printer, ETCO
00-1026-R: standard configuration with printer, invasive pressure (2 channels), ETCO
temperature (1 or 2 channels).
For a full list of Tempus Pro features, see “1.6 Features list”.
Note
The Tempus Pro is supplied in different configurations depending on the customer’s requirements. This
manual is written to cover all Tempus Pro features and therefore details regarding optional features will not
be applicable to all units.
Tempus Pro pulse oximetry provides the standard SpO2, pulse rate and perfusion index (PI)
measurements but also has the capability to monitor carboxyhaemoglobin saturation
(SpCO), methaemoglobin saturation (SpMet), total haemoglobin concentration (SpHb), total
oxygen content (SpOC) and pleth variability index (PVI).
and contact temperature (1 or 2 channels).
2
and contact temperature
2
, contact temperature (1
2
and contact
2
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 9
Chapter 1 Introduction
1.1 CE statement
Marking by the above symbol indicates compliance of this device to the Medical Devices Directive (MDD)
93/42/EEC (as amended) and the Radio Equipment Directive (RED) 2014/53/EU (as amended). The CE
mark is accompanied by the number 0413 which is the reference number for the Notified Body who certify
RDT’s quality system.
The Tempus Pro is a class IIb device under the MDD and is a class I device (harmonised frequencies) under
the Radio Equipment Directive (RED) 2014/53/EU.
A Declaration of Conformity in accordance with the above regulations has been made and is on file with
RDT, see “RDT contact details”.
The wireless portion of this equipment may be operated in GB, France, Italy, Switzerland, Germany,
Holland, Portugal, Spain, Sweden, Norway, Denmark and Finland.
1.2 FDA prescription statement
Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician.
1.3 Proprietary notice
Information contained in this document is copyright © 2013-2019 by Remote Diagnostic Technologies
Limited ('RDT') and may not be reproduced in full or in part by any means or in any form by any person
without prior written permission from RDT.
The purpose of this document is to provide the user with adequately detailed information to efficiently install,
operate, maintain and order spare parts for the Tempus Pro. Every effort has been made to keep the
information contained in this document current and accurate as of the date of publication or revision.
However, no guarantee is given or implied that the document is error free or that it is accurate with regard to
any specification. RDT reserves the right to change specifications without notice.
Tempus Pro, Corsium, Corsium Crew, RachBak, i2i and TempusNET are all trademarks of RDT.
The Bluetooth name and logo are owned by the Bluetooth SIG Inc. and any use of this name or mark is
under license.
The following trademarks are the property of Oridion Medical Ltd.: Oridion, Microstream, FilterLine,
(FilterLine Set; FilterLine H Set, Nasal FilterLine), CapnoLine (Smart CapnoLine, Smart CapnoLine O2,
Smart CapnoLine Plus, Smart CapnoLine Plus O2, Smart CapnoLine H Plus, Smart CapnoLine H Plus O)
and Integrated Pulmonary Index (IPI).
The following trademarks are the property of Masimo Inc, SET, PVI, Rainbow, FastSAT.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any expressed or implied license to use the device
with unauthorized sensors or cables that would, alone, or in combination with this device, fall within the
scope of one or more of the patents relating to this device.
Masimo and the Masimo SET logo are the property of Masimo Inc.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 10
1.6 Features list
Username
Password
1.4 Use of this manual
The instructions and safety precautions provided in this manual must be observed during all phases of the
operation, usage, service or repair of the Tempus or its accessories. Failure to comply with the information
contained in this manual e.g. warnings, precautions, instructions etc. will violate the safety standards of
design, manufacture and intended use of the products. Remote Diagnostic Technologies Ltd. assumes no
liability for customer failure to comply with the information contained in this manual.
WARNING
CAUTION
Please check RDT’s website regularly for new versions of this manual: https://www.rdtltd.com/support-and-
resource-centre/.
To access the manual, you will need to enter the following details:
The Tempus is intended to be operated by clinically qualified personnel only. This
manual, as well as accessory directions for use and all precautionary information and
specifications should be read before use.
Separate manuals are provided for the setup and maintenance of the device. These
manuals are intended for the communications engineers and Bio-medical engineers
responsible for such activities and are available from RDT upon request.
TEMPUSPROnnnn
w265nnnn
“nnnn” is the last four digits of your Tempus Pro serial number.
1.5 Intended users
RDT assumes that users of the product are clinically trained in how to take and interpret a patient’s vital
signs.
The Tempus Pro and this manual are intended to be used by such clinically-trained personnel. While the
Tempus Pro has been designed as a good quality monitor; RDT reminds users that no monitor can replace
good clinical judgment or the care and attention of a clinician. Before attempting to work with this
equipment, the user must read, understand note and strictly observer all warnings, cautions and safety
markings in this manual, other associated labelling and on the equipment.
It is the user’s responsibility to ensure they are properly prepared to use the product. No formal training
should be required so long as the user reads this manual thoroughly and familiarises themselves with the
product before use. RDT can provide direct training courses if preferred.
1.6 Features list
All Tempus Pro monitors come with the following items:
Lithium-ion battery
Non-invasive blood pressure hose
Non-invasive blood pressure cuff
Masimo patient cable
Tempus Pro ECG cable
Tempus mains power supply and mains cable
Tempus Pro user manual set (CD-ROM)
The following additional items may be included:
Configurations with a built in capnometer (optional) are provided with an Oridion Military and Air
Medical Sample Pack.
Configurations can include an optional 2 Channel Invasive Pressure Module (part number 01-2017).
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 11
Chapter 1 Introduction
1.7 Patent and warranty
1.7.1 Patent claims
RDT has applied for patents covering the Tempus Pro and its communications technology in the following
jurisdictions: Patents Pending (US No.2006/0287586 EP 1734458 A & other areas).
The capnography component of this product is covered by one or more of the following US patents:
6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent
applications pending.
PATENT MARKING: This device is covered under one or more of the following U.S.A. patents:5,758,644,
5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975, 7,469,157and other applicable patents listed at
http://www.masimo.com/patents.htm.
1.7.2 Limited warranty
Remote Diagnostic Technologies Limited ('RDT') warrants each new Tempus to be free from defects in
workmanship and materials under normal conditions of use and service. For details please refer to the
Terms and Conditions of Sale. Consumable items are expressly excluded from this Warranty. RDT's sole
obligation under this warranty will be to repair or (at RDT's option) replace products that prove to be
defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth
herein, RDT makes no warranties, either expressed or implied, including the implied warranties of
merchantability and fitness for a particular purpose. The warranty shall be void if the Tempus is in any way
modified or used with non-approved consumables, unless specifically authorised in writing by RDT, and RDT
shall not be liable in any event for incidental or consequential damage. This warranty is not assignable.
Full terms and conditions of sale are available from RDT and are provided with your order confirmation.
All specifications quoted in this manual are nominal unless detailed otherwise.
1.7.3 Service support and returns
Repairs made under warranty to any Tempus must be made by the manufacturer. If the device requires
repair or return for any reason, please contact your local distributor or Remote Diagnostic Technologies in
order to first obtain a returns reference (RMA) number, see “RDT contact details”.
RDT reserves the right not to accept returns which have not first been provided with an RMA number. When
calling, please be ready to quote the serial number of the device.
The Tempus Pro is designed to be as maintenance free as possible. The only user replaceable and user
serviceable parts are those listed in section 11 of this manual.
In the event that the Tempus Pro 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.
If the device malfunctions and may have caused or contributed to a serious injury of a patient or user, RDT
must be notified immediately by telephone, fax or written correspondence.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 12
2 Warnings and cautions
2.1 Safety and note icons
This manual uses the following icons are used to indicate safety, caution and warning messages
(per ISO 3864-2):
DANGER
WARNING
CAUTION
The note icon is used for important and helpful information:
Note
Indicates an imminently hazardous situation which, if not avoided, will result in death
or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in death
or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in minor or
moderate injury.
A point of particular interest or emphasis intended to provide more effective or convenient
operation.
2.2 EMC information
The Tempus Pro Patient Monitor has been tested and approved to IEC/EN60601-1-2:2014. This means that
the Tempus meets or exceeds the requirements for electrical medical equipment in terms of its levels of
emitted electromagnetic (EM) radiation and its susceptibility to electromagnetic radiation from other devices.
In addition, the Tempus Pro has been tested according to the requirements of RTCA DO-160-G section 21
category M.
It should be noted that the Tempus Pro may be affected by high levels of stray EM radiation from other
electronic devices (even those which comply with relevant CISPR emission standards) that are being used
in close proximity to it.
As required by international medical device standards, the Tempus Pro is intended for use in
electromagnetic environments of 8kV static contact (15kV air discharge) and magnetic fields of 30 A/m
(50/60Hz). The Tempus Pro is proof against radiated RF emissions from 80MHz to 2.7GHz to a level of at
least 3V/m. In the event that the Tempus Pro will be used in environments with RF levels exceeding this,
please contact RDT for further information.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 13
Chapter 2 Warnings and cautions
This system is intended for use by healthcare professionals only. This system may
WARNING
Operating high frequency electrosurgical equipment in the vicinity of the monitor can
produce interference in the monitor and cause incorrect measurements.
WARNING
Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the
function of the monitor may be disturbed.
WARNING
cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting or relocating the Tempus
or shielding the location.
CAUTION
Tempus has been tested in a “heavy” wireless environments consisting of different wireless
technologies (Bluetooth, WiFi 802.11 b and cellular communications) with multiple
transmitters used simultaneously. Users deploying the Tempus in environments where
other wireless technologies are being used should evaluate the potential risk of interference
and aggregate spectrum usage.
2.3 Indications for use
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified
personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and prehospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12-lead ECG
recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/alarming and ST
measurements/alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2
(ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and
extended pulse oximetry capability including; carboxyhaemoglobin (SpCO), methaemoglobin (SpMet), total
haemoglobin (SpHb) and total oxygen content (SpOC) measurements.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting
patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz
Small Parts/Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. The
monitor can also be used to display the following readings from a Masimo ISA OR+ gas module*: end-tidal
and fractionally inspired CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane.
These optional accessories are to be used in accordance with their indications for use.
* Not cleared for use with the Tempus Pro in Canada or the USA.
2.3.1 Contraindications
The Tempus Pro does not replace a physician’s care. The device is not an apnoea monitor.
The Tempus Pro is not intended to be used in strong magnetic or electro-magnetic fields which are
generated for medical purposes e.g. MRI.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 14
The FilterLine may ignite in the presence of O2 when directly exposed to laser, ESU
To ensure patient electrical isolation, only connect Tempus Pro to other systems
Do not autoclave, ethylene oxide sterilise, or immerse in liquid the Tempus or an
y of
The Tempus should not be stacke
d next to other equipment. If this is necessary
2.4 General warnings, cautions and notes
2.4 General warnings, cautions and notes
DANGER
DANGER
WARNING
WARNING
WARNING
WARNING
WARNING
ELECTRICAL SHOCK HAZARD when covers are removed. Do not remove covers.
Refer servicing to qualified personnel authorised by RDT.
Explosion Hazard: DO NOT use the Tempus Pro in the presence of flammable gasses
such as fuels. Use of the Tempus Pro in such environment may present an explosion
hazard.
devices, or high heat. When performing head and neck procedures involving laser,
electrosurgical devices or high heat, use with caution to prevent flammability of the
FilterLine or surrounding surgical drapes.
The use of the or the or the symbols indicates that the user must
read the user manual before using the product.
When used with the mains power supply, to avoid the risk of electric shock the power
supply must only be connected to a supply mains with a protective earth.
Do not connect the Tempus Pro to an electrical outlet controlled by a wall switch or
dimmer.
which are compliant with the relevant IEC standard e.g. IEC60950, and which employ
suitably electronically isolated circuits. Signal input and output connectors are only
for connection to equipment complying with relevant IEC safety standards and must
be configured to comply with IEC60601-1-1 or IEC60601-1:2005.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Attaching different medical systems together can cause increases in leakage
currents. If the Tempus is connected to other medical devices, or if the patient has
multiple devices attached to them at the same time, the cumulative effect of leakage
currents must be considered.
Do not touch the patient at the same time as touching the body or contacts of any of
the medical or communications or power connectors.
Many environmental variables, including patient physiology and clinical application,
can affect the accuracy and performance of the monitor. The clinician must verify all
vital-signs information prior to patient intervention.
its cables or accessories as this may cause sensor damage which may result in
inaccurate readings.
Attention should be paid to the following EMC information prior to installing or using
the device.
verify normal operation if utilizing device adjacent to or stacked with other electrical
equipment.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 15
Chapter 2 Warnings and cautions
Any device or accessory that has been dropped, damaged or subjected to harsh
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Portable and mobile Radio Frequency (RF) communication equipment may interfere
with the operation of the device.
Computers, cables and accessories not tested to IEC/EN60601-1-2 or equivalent IEC
standards may result in increased emissions or decreased immunity of the device.
Follow precautions for electrostatic discharge (ESD) and electromagnetic
interference (EMI) to and from other equipment.
Only use Tempus Pro with the relevant cables and peripherals provided by RDT. Use
of any other accessories could result in inaccurate measurements. Use of any other
cables or accessories could affect defibrillator protection.
Exposure of the wireless communication features of the Tempus Pro or its
accessories may be interfered with by other devices which operate at the same
frequencies.
The sensors of the Tempus Pro are only for contact with intact and undamaged skin.
usage or extreme environmental conditions should be inspected by qualified service
personnel prior to use to ensure proper operation.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
The ECG device is not intended for use in a sterile environment. Do not use for direct
cardiac application.
Do not attempt to insert the ECG device (including patient cables) into an electrical
outlet.
The ECG recorder and monitoring functions are for resting ECG and should not be
used in stress testing environments.
Though false positive errors will intentionally outnumber false negative errors, both
will occur, thus the necessity for over reading by a qualified physician of any
computer-interpreted ECG. The computer interpretation does not produce a definitive
diagnosis.
Ensure electrodes are connected only to patient.
Conductive parts of electrodes and connectors, including neutral electrode, should
not contact other conductive parts including earth.
Always keep motion to a minimum. Motion artefact can potentially affect the
accuracy of patient readings.
WARNING
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 16
Do not connect more than one patient to a monitor. Do not connect more than one
monitor to a patient.
2.4 General warnings, cautions and notes
Do not place the monitor or its accessories in locations where they could
fall onto the
The Tempus Pro is protected against defibrillator discharge but rate meters and
During defibrillation, keep the defibrillator’s paddles or electrodes away from the
Do not apply excessive tension to any cable.
Using a damaged patient sensor may
Using
a damaged patient cable may cause inaccurate readings, possibly resulting in
Ensure that close a
ttention is paid to the alarm configuration settings of the product.
Do not attempt to charge a non
-
rechargeable battery. Never over charge, crush, heat
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Do not use the Tempus in a Magnetic Resonance Imaging (MRI) suite or a hyperbaric
chamber.
patient. When moving the product take care that any connected leads and sensors
are not jerked so that they become detached or damaged.
displays may be temporarily affected during defibrillator discharge but will rapidly
recover.
monitor’s ECG wires, electrodes and any other sensors or conductive parts of the
monitor.
Pacemaker signals can differ from one pacemaker to the next. The Association for
Advancement of Medical Instrumentation (AAMI) cautions that “in some devices, rate
meters may continue to count the pacemaker rate during occurrences of cardiac
arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. All
pacemaker patients should be kept under close or constant observation.”
Device may not operate effectively on patients who are experiencing convulsions or
tremors.
Misuse or improper handling of the device or its sensors or cables can cause damage
which may lead to equipment failure or inaccurate readings.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
cause inaccurate readings, possibly resulting in patient injury or death. Inspect each
sensor. If a sensor appears damaged, do not use it. Use another sensor or contact
your authorized repair centre for help.
The Tempus and all its cables and accessories should be inspected frequently to
check for damage. Any worn or damaged items should be replaced. Failing to
thoroughly and regularly inspect and maintain the product could result in hazards to
patients or equipment failure.
injury or death. Inspect the patient cable. If the patient cable appears damaged, do
not use it. Contact your authorized repair centre for help.
If alarm volumes are turned down or if the product is used in noisy environments,
then the alarm may not be audible. If alarms are muted this will be indicated on the
screen. Always ensure the screen of the Tempus can be seen in case the audible
alarms cannot be heard or are turned off.
or incinerate, short-circuit, deform, puncture, dismantle or immerse the batteries in
any liquid.
Only use rechargeable batteries and battery chargers specified by RDT.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 17
Chapter 2 Warnings and cautions
The alarm functions of the Tempus are intended to be used by the attendant user
Medical data (vital signs data, photos, ECG recordings, patient details, TCCC cards
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Ensure patient cabling or tubing is carefully routed on device to reduce the
possibility of patient entanglement or strangulation.
All numerical, graphical and interpretive data should be evaluated with respect to the
patient's clinical and historical picture.
Do not attempt to insert any connections from the Tempus Pro (including patient
cables) directly into an electrical outlet. (IEC60601-2-34:2011, 2011).
Failure of Operation: If the Tempus Pro fails to respond as described in this user
guide; DO NOT use it until approved for use by qualified personnel.
Reuse, disassembly, cleaning, disinfecting or sterilizing of any single use items (such
as the Capnometer cannula) may compromise functionality and system performance
leading to a user or patient hazard. Performance is not guaranteed if an item labelled
as single patient use is reused.
Do not touch the patient at the same time as touching the body or contacts of any of
the medical or communications or power connectors.
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 part number 01-1022). Any connections made to the USB port
must be to medical or IT peripherals or communications systems which comply with
the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection
arrangements must be made in a manner compliant with IEC60601-1-1 or IEC606011:2005.
WARNING
WARNING
WARNING
only. If the device is connected to a Response Centre this is for the purpose of
sharing vital signs data in real time, between two users for the purpose of obtaining
additional clinical support. The system is not a distributed alarm system (e.g. nurse
monitoring station system) in the terms of IEC60601-1-8. The i2i system at the
Response Centre is not equipped with alarm silencing or suspending controls.
When connected to a PC running the i2i application at a Response Centre, streamed
data, such as the waveforms displayed on the Tempus Pro, will be transmitted and
displayed automatically on that PC’s display. Users are advised that streamed data
are transmitted using the UDP protocol. The UDP protocol includes error checking
but does not retransmit data. Therefore, any data that is dropped, lost or delayed
during the streaming process will not be retransmitted. In the event that packets of
waveform data are lost, they will appear as gaps in the waveform that is displayed on
the i2i interface.
etc.) are transmitted using TCP/IP, this includes error checking and retransmission so
missing or dropped packets are therefore retransmitted.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 18
WARNING
Do not disassemble
the device. The device must only be serviced by trained and
2.4 General warnings, cautions and notes
authorised biomedical engineers following RDT approved procedures and using parts
provided by RDT. Any other changes or processes are unauthorised and should not
be performed. No other modifications are allowed. Unauthorised processes, repairs,
modifications, reworks or service not expressly approved by RDT could void any
guarantees and warrantee and could be hazardous. Do not modify this device
without authorisation from RDT. If the device is modified, appropriate inspection and
testing must be conducted to ensure continued safe use of the device.
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
The Tempus may be used on ambulances or on vehicles using radios. As detailed in
section 14.5, it has been tested to determine operation in field strengths greater than 3V/m.
Users are advised to maintain the best distance possible between radio antennas and the
Tempus as best practice.
This device is intended for use by persons trained in professional health care. The operator
must be thoroughly familiar with the information in this manual before using the device.
The Tempus Pro may not operate correctly if used or stored outside the relevant
temperature or humidity ranges described in the performance specifications of this manual.
Only use only approved accessories supplied by RDT. Conventional 4mm snap-on, pregelled ECG electrodes may be used so long as they comply with AAMI EC12. Users are
reminded to read and adhere to the instructions for such electrodes including noting single
use only status, maximum usage times and patient indications.
Do not clean the Tempus or its accessories except as directed in this guide.
In the event that the device displays an error that is not described within this manual e.g.
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.
The Tempus records all data that it measures. In order to ensure that data from different
patients is not confused, the device must be switched off between taking readings from
different patients or the patient discharge function used.
CAUTION
Should the device become wet, wipe off all moisture and allow sufficient time for drying
before operating. Take care to ensure that water or liquids are not spilt over the device or
into its ventilation holes in the side corners.
CAUTION
CAUTION
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.
Follow local government regulations and recycling instructions regarding disposal and
recycling of device and device components.
The Tempus Pro 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.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 19
Chapter 2 Warnings and cautions
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Dispose of batteries in accordance with applicable regulations which vary from country to
country. In most countries, the disposal of used batteries is forbidden in general domestic
and commercial waste and the end-users are invited to dispose of them properly, typically
through not-for-profit profit organisations, mandated by local governments or organised on a
voluntary basis by professionals.
Pressing buttons or the touch screen with sharp or pointed instruments may cause
permanent damage. Only fingers should be used to press these keys.
Do not reconnect the headset to its docking pin when the main battery is very low or flat
(less than 10% charge – as represented by a single flashing LED on the battery charge
indicator). Doing this could reduce the battery charge into a “deep discharge” state (where
no battery lights come on).
Use of monitoring during continuous nebulised medication delivery will result in damage to
the device which is not covered by the warranty. Disconnect the Capnometer sample line
from the device, or switch off the device, during medication delivery.
Observe proper battery polarity (direction) when replacing batteries. The batteries slide
easily into place when correctly oriented and should not be forced.
The mobile RF communications equipment contained within the device and its accessories
can affect other medical devices that are in close proximity to the device.
Use of the RF communications equipment contained in the device and its accessories may
be prohibited in a number of areas. These include: on aircraft in-flight (including during
take-off and landing), near defibrillators (that are in use), near other electronic medical
devices and in hospitals.
CAUTION
In addition, the use of the RF communications equipment contained in the device and its
accessories may be prohibited in explosive atmospheres e.g. in fuelling areas, near fuel or
chemical transfer or storage areas and in areas containing chemicals or particles such as
grain, dust or metal powders.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 20
2.4 General warnings, cautions and notes
CAUTION
The use of the RF communications equipment contained in the device and its accessories
may cause interference with implanted pacemakers and other medically implanted
equipment.
A minimum distance of 2.3 m (7.5 ft) must be maintained between the device and its
accessories (containing RF communications equipment) and other medical equipment
(including implantable medical devices such as defibrillators and pacemakers). 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 IEC60601-1-2:2014.
If the intended patient has an implantable device (e.g. pacemaker), do not use any of the
Tempus Pro’s RF communications equipment (e.g. Bluetooth
®
or WiFi) before using the
device to record the patient's physiological data. After the data recording session is
completed, move the device at least 2.3 m (7.5 ft) away from the patient, and then use it
normally to communicate with the base station. Otherwise, radiofrequency radiation from
the device (up to 63mW) may adversely impact the implantable pacemaker in the patient. If
the patient's implantable device has an immunity level less than 10 V/m, the separation has
to be greater than 2.3 m (7.5 ft).
If you suspect interference is being caused, disconnect from the Response Centre by
pressing . Interference could include visible interference on equipment displays, audible
interference e.g. buzzing, from speakers of other equipment, or equipment unexpectedly
changing state e.g. functions starting or stopping.
Example of a PC display without interference:
Example of a PC display with interference:
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 21
Chapter 2 Warnings and cautions
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
When using the device with GAN terminals, in order to avoid the risk of interference from the
output beam from the antenna of the terminal with the operation of the device, ALWAYS
ensure that the device is situated at least 6m behind the face of the antenna. Since the
power of the GAN terminal’s beam is high (25W approx.), care should be taken to ensure
that the antenna remains fixed and to maintain the device away from the face (and therefore
the beam) of the antenna.
RF energy may affect some electronic systems in motor vehicles, such as car stereo, safety
equipment, etc. Check with your vehicle manufacturer’s representative to be sure that your
product will not affect the electronic system in your vehicle.
Do not use the Tempus Pro’s Bluetooth® or WiFi communications on-board any aircraft
where its use is prohibited.
Take care to minimise the risk that trailing cables will be caught by passers by.
Prior to deployment of Tempus Pro there are settings that user organisations need to
configure. Carefully check all the relevant settings on each Tempus Pro before it is
deployed. For more information, see “4.1 Before deployment”.
If you use mounting systems that are not supplied or approved by RDT, we cannot
guarantee the performance of the Tempus Pro.
Note
Note
Note
Note
Note
Note
Note
Note
Note
The Tempus has been tested and found to comply with IEC/EN 60601-1-2.
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 an external charger (additional 24 hours) in order to restore normal
operation.
Important! The Tempus Pro is intended for use in the electromagnetic environment(s)
specified in this manual. Users of this equipment should ensure that it is used in such
environment(s).
After the life cycle of the Tempus Pro and its accessories have been met, disposal should
be accomplished following national and/or local requirements.
Operation of the device may be adversely affected in the presence of conducted electrical
transients or strong electromagnetic or radio frequency sources such as electrosurgery and
electrocautery equipment, HF radio transmission antenna, x-ray machines and high intensity
infrared radiation.
All user and patient accessible materials are non-toxic.
Hazards arising from software errors have been minimised. Hazard analysis was performed
to meet the requirements of EN14971 and IEC60601-1-4.
Each external connection and part of the device is electrically isolated.
Performance and safety test data are available on request from RDT, see “RDT contact
details”.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 22
2.4 General warnings, cautions and notes
Note
Note
Note
Note
Note
Note
GSM usage is restricted by the network availability, roaming agreements and local provision
of circuit mode connections.
IP sealing is not guaranteed if the device is subject to rough handling, impact, improper use
or rapid decompression.
Device should be returned for service if it is subject to rough handling and IP sealing is
needed to be relied upon.
The device specifications are subject to change without notice.
It is recommended that the device is connected to the Response Centre every month for a
test patch.
The iAssist help processes on your Tempus Pro may differ from the example iAssist help
process used in this manual; however, the process always follows the same key elements.
Note
Note
Note
Note
Note
Always ensure that you read the complete iAssist help process in order and do exactly what
it requires.
For optimum performance of the wireless communications, please make sure that there is
no metal surrounding the Tempus Pro.
Over bending the folding foot or RapidPak clip could cause them to be damaged. Do not
over-bend these items.
Take care when repacking cables to ensure they cannot be snagged or damaged in the
RapidPak clip and the folding foot.
The Tempus Pro should be repacked following the relevant instructions. Lost or damaged
cables and accessories should be replaced with spares ordered from RDT.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 23
Chapter 2 Warnings and cautions
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 24
3 Introduction to the
Tempus Pro
The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital and remote
locations. It provides the user with conventional patient monitoring parameters for use in measuring and
monitoring patient’s vital signs.
The device also provides the user with the ability to capture patient incident data in electronic format. This
data can be passed from one Tempus to another to enable the patient’s record to remain with them as they
move from one caregiver to another.
In addition, the device also gives the user the ability to transmit all data in real-time to a Response Centre
using a variety of integrated communications interfaces. If data is being transmitted, the device also allows
the user to transmit still or moving pictures via an integrated digital camera and also to speak to the
Response Centre using a wired or wireless headset.
The Tempus Pro is intended to be used by trained clinical staff.
The Tempus Pro can provide the following information about the patient from its sensors:
ECG Monitoring;
Real-time arrhythmia detection and alarming;
Real-time ST and QT measurement and alarming;
12 Lead Diagnostic ECG Recording;
12 lead ECG recording interpretation;
Impedance pneumography (respiration rate measured through ECG leads);
Heart rate (from ECG) or pulse rate (from pulse oximetry);
Non-invasive blood pressure;
End tidal CO2 (ETCO2);
Respiration rate;
Pulse Oximetry including Oxygen saturation (SpO2) pulse oximetry (SpO2), Total Haemoglobin
(SpHb), Methaemoglobin saturation (SpMet), Carboxyhaemoglobin (SpCO), Oxygen Content (SpOC),
Pleth Variability Index (PVI);
Temperature;
Invasive pressure.
Tempus Pro is also able to display ultrasound and video laryngoscopy images on its large colour display
utilising third party ultrasound probes and video laryngoscopy accessories. For more information, please
refer to Tempus Pro Ultrasound Supplement Guide (Part number 42-2003) and Tempus Pro Laryngoscope
Supplement Manual (Part number 42-2004).
To display anaesthetic agent gas vital signs on the Tempus Pro, you can use the Masimo ISA OR+
Anaesthetic Gas module (available from RDT). For more information, see the Tempus Pro AA Gas
Supplement Guide.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 25
Chapter 3 Introduction to the Tempus Pro
3.1 Overview of the Tempus Pro
The Tempus Pro consists of a PC-ABS plastic enclosure which is over-moulded with TPU material to make it
resistant to shock. The enclosure also includes the RapidPak
sensor, the adult NIBP cuff and hose and the ECG cable.
The unit has a clear window on the top which contains the alarm bar. This lights yellow or red for clinical
alarms. The alarm bar can be configured by the user to light green in all non-alarm conditions. The alarm
bar has a small aperture at the rear of the case which allows the alarm status to be seen from the rear. In
addition, light from the alarm bar is distributed by the translucent handle which sits across the top of the
device.
TM
clip which provides storage for the SpO2
3.2 Key features of the unit
3.2.1 Tempus Pro front
On the front of the unit is a large, colour display which is fitted with a touchscreen. The touchscreen may be
used with a gloved hand or plastic stylus. Around the touchscreen are two panels of membrane buttons
(left/below and right).
Also on the front are grilles covering the alarm speaker. Care should be taken not to probe through the
grilles with any sharp or pointed object.
Carry strap
Speaker
Alarm Bar
Membrane
buttons
The Tempus Pro
Touchscreen
Battery
3.2.2 Tempus Pro base
The base of the Tempus Pro houses the battery. The battery can be removed by pushing the latches at
each end of the battery together. This will release the battery allowing it to be pulled out.
The battery includes a charge level button and four indicator lights.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 26
3.2 Key features of the unit
3.2.3 Tempus Pro rear
Non-printer models
If the Tempus Pro is not fitted with an internal printer (part number 00-1004-R or 00-1007-R):
The rear houses the RapidPak clip (discussed above).
Also on the rear is the aperture for the camera and backlight.
The clip carries a general product label for regulatory purposes and also two labels which help guide
the user to repack the SpO
If the Tempus Pro is a non-printer model with Bluetooth headset (part number 00-1007-R):
The Bluetooth headset is docked onto a connector which enables the Tempus Pro to top its charge
up automatically on a regular basis, thus ensuring the headset is always ready to use.
The Bluetooth headset is a Sennheiser Presence or Sennheiser VMX200.
Rear alarm
light
sensor and the ECG cable.
2
BP cuff
Camera and
backlight
Heatsink
3 or 5 wire
ECG Cable
SpO2 sensor
The Rear of the Tempus Pro (non-printer model)
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 27
Chapter 3 Introduction to the Tempus Pro
CAUTION
Printer models
If the Tempus Pro is a printer model (part number 00-1022-R, 00-1024-R or 00-1026-R):
The rear houses the internal thermal printer.
Also on the rear are the camera, backlight and moveable foot.
The RapidPak clip is absent.
The ECG cables, SpO2 sensor and NIBP cuff are stored in the bag.
(1) Rear alarm light
(2) Camera and
backlight
(3) Printer
The Rear of the Tempus Pro (printer model)
3.2.4 Tempus Pro left side
The left side of the device contains seven connectors for:
ECG monitoring and Diagnostic ECG - green;
NIBP - white latching connector;
Pulse oximeter (SpO2 and pulse rate) – light grey
Invasive pressure – white;
Capnometer (ETCO2 and respiration rate) - yellow;
Contact temperature (2 sockets marked T1 & T2) - turquoise.
WARNING
Do not touch the patient at the same time as touching the body or contacts of any of
the medical or communications or power connectors.
Consideration needs to be made to the potential for leakage currents to be created if the
Tempus or its connectors are made wet or dusty. In the event that any connectors (but
particularly patient leads i.e. ECG, Invasive Pressure, SpO
respective sockets become wet or contaminated with sand or dust, they should be cleaned
and dried before use – see “10.2.4 Cleaning the NIBP cuffs and hose”.
Connectors and their immediate surrounding areas should be clean and dry at all times.
, contact temperature) or their
2
Normally the ECG, NIBP and SpO2 connectors will have their sensor cables attached at all times.
The Tempus’ connectors are rated IP66 in their own right and are therefore water proof and sand proof
against ingress of water or particulate into the device’s enclosure without the covers. The covers provide
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 28
3.2 Key features of the unit
The USB connection must only be connected to non
-
mains powered periphe
rals
door
additional protection to prevent nuisance ingress of sand into the connectors in the event that a cable or
sensor is not in place.
ECG cable
NIBP hose
Pulse Oximetry
(SpO2) patient
cable
Invasive
Pressure door
Capnometer
Contact
Temperature
doors
Left side of the Tempus – medical connectors
3.2.5 Tempus Pro right side
The right side of the Tempus houses the data communication and power connections. These comprise:
Two USB 1.0 & 2.0 sockets – these are reserved ONLY for non-mains powered radios (or other
communications devices), non-mains powered USB peripherals (such as keyboards) or non-mains
powered medical accessories. Any accessory or peripheral attached to the Tempus MUST be
approved for use with the Tempus Pro by RDT.
Mains Power – only use the Tempus Pro approved mains power supply part number 01-2049 provided
by RDT.
Audio – this is only for use with the Wired Headset (part number 01-1019) supplied by RDT or for use
with the Tactical Headset Adaptor Cable (part number 01-2041) supplied by RDT (this cable adapts to
Peltor® or similar military-style headsets).
Tactical Switch – this switch allows the user to switch the Tempus’ visual and audible outputs to a
minimal setting and is described in section 4.3.2.
WARNING
approved by RDT and documented in this manual, or to interface accessories
provided by RDT. Any connections made to the USB port must be to medical or IT
peripherals or communications systems which comply with the applicable IEC safety
standard (i.e. IEC60601-1 or IEC60950). Any connection arrangements must be made
in a manner compliant with IEC60601-1. Users must ensure that they prevent the
patient from coming into contact with the peripheral and also must ensure the user
does not touch the peripheral while touching the patient. Alternatively, a suitable
isolation device can be used. RDT recommends the use of appropriate opto-isolation
devices such as the Ulinx™ Model UH401 or the Baaske USB 1.1 isolator. Further
details can be obtained from RDT upon request.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 29
Chapter 3 Introduction to the Tempus Pro
Always use a Baaske MI 1005 isolation device when connecting from the Ethernet
The Ethernet connection
must only be connected to battery powered (non
-
mains
-
WARNING
socket to any mains-powered communications device (e.g. router, access point, hub,
communications terminal etc.).
WARNING
powered) communications devices such as laptop computers or satellite
communications terminals such as BGAN or VSAT terminals. Any connections made
to the Ethernet port must be to medical or IT peripherals or communications systems
which comply with the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950).
Any connection arrangements must be made in a manner compliant with IEC606011:2005 or IEC60601-1-1:2001. Users must ensure that they maintain the
communications device 1.5 m away from the patient and also must ensure the user
does not touch the communications device while touching the patient. If such
devices require mains power then the device must be powered using a power supply
compliant with the electrical isolation requirements IEC60601-1.
WARNING
WARNING
CAUTION
CAUTION
The audio connector must only be connected to unpowered microphone headsets or
battery powered microphone headsets (such as Peltor® or Bose®). Further details
can be obtained from RDT upon request.
Do not touch the patient at the same time as touching the body or contacts of any of
the medical or communications or power connectors.
Do not use USB hubs (powered or unpowered) with the Tempus. This could cause the USB
sockets to cease operating.
Consideration needs to be made to the potential for leakage currents to be created if the
Tempus or its connectors are made wet or dusty. In the event that any or their respective
sockets become wet or contaminated with sand or dust, they should be cleaned and dried
before use – see “10.2.3 Cleaning connectors”.
Connectors and their immediate surrounding areas should be clean and dry at all times.
Ensure the communications connectors are securely covered with their dust covers (if fitted)
at all times.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 30
3.3 Theory of operation
Power socket
Headset socket
Tactical switch
Ethernet RJ-45
socket
Two USB A sockets
for USB 1.0 & 2.0
communications
Right Side of the Tempus – Communications Connectors
3.3 Theory of operation
All of the measurements made by the Tempus Pro are displayed on the screen. Attaching a sensor to a
patient will initiate measurements by that particular parameter. Monitoring will continue until the sensor is
removed from the patient or the unit (and the consequent alarm is silenced). In the case of non-invasive
blood pressure, measurements start once the user presses the ‘start’ button and will continue on a regular
basis when in automatic mode until either the cycle is stopped by the user or the unit is unable to take a
reading e.g. cuff is removed.
3.3.1 Pulse rate and oxygen saturation (SpO2)
Pulse oximetry measures functional oxygen saturation.
Pulse oximetry is based on the following:
The difference in the absorption of red and infrared light (spectrophotometry) by oxyhaemoglobin and
deoxyhaemoglobin
Changes in the volume of arterial blood in tissue during the pulse cycle (plethysmography), and hence,
light absorption by that blood.
A pulse oximeter determines Spot Oxygen Saturation (SpO2) by passing red and infrared light into an
arteriolar bed and measures changes in light absorption during the pulsatile cycle. Red and infrared low
power light emitting diodes (LEDs) in the oximetry sensor serve as light sources; a photodiode serves as the
photo detector.
Since oxyhaemoglobin and deoxyhaemoglobin differ in light absorption, the amount of red and infrared light
absorbed by blood is related to haemoglobin oxygen saturation. To identify the oxygen saturation of arterial
haemoglobin, the monitor uses the pulsatile nature of arterial flow.
During systole, a new pulse of arterial blood enters the vascular bed and blood volume and light absorption
increase. During diastole, blood volume and light absorption reach their lowest point.
The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption
(measurements at systole and diastole). The focus of light absorption by pulsatile arterial blood eliminates
the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 31
Chapter 3 Introduction to the Tempus Pro
Pulse rate and oxygen saturation are detected by a soft reusable finger probe packed on the rear of the
device (disposable sensors may also be used). In particular it is also important that the sensor is not used
on the same arm as the blood pressure cuff, because false readings may occur when the cuff is inflated.
Readings will not be obtainable or may be inaccurate from patients with some colours of nail varnish or
polish.
Masimo® SET® Rainbow® measurements use a multi-wavelength sensor to distinguish between
oxygenated blood, deoxygenated blood, blood with carbon monoxide content and blood with oxidized
haemoglobin. The sensors have various light emitting diodes (LEDs) that pass light through the site to a
photodiode (photodetector). The maximum radiant power of the strongest light is rated at 22 mW. The
photodetector receives the light and converts it into an electronic signal. Masimo® SET® Rainbow® signal
extraction technology then calculates the measurement values.
3.3.2 Non-invasive blood pressure
The Tempus Pro uses oscillometric technology to measure the patient's blood pressure non-invasively. A
pump within Tempus Pro inflates the reusable blood pressure cuff around the patient's arm. Circulating
blood within the arm causes slight changes (oscillations) in the cuff pressure, which can be detected and
measured. As the inflation pressure changes, the systolic, diastolic and mean arterial pressure can be
measured.
This method of blood pressure measurement provides accurate readings provided that the correct size of
cuff is used, it is attached to the patient correctly and the specified operating precautions are observed.
3.3.3 Electrocardiograph (ECG)
The ECG is intended to monitor patients of all ages in hospital and pre-hospital applications (including
transport) for general cardiac monitoring. Electrical currents influenced by the cardiac impulse flow through
the body tissue around the heart. The Tempus Pro can be used with:
a 3-lead cable to monitor ECG leads I-III;
a 4-lead cable to monitor ECG leads I-III, AvR, AvL and AvF;
a 5-lead cable to monitor ECG leads I-III, AvR, AvL, AvF and a user-placeable V lead.
Twelve lead diagnostic recording functionality is available as an option. To support this, use one of the
standard or modular 12-lead cables (including precordial chest electrodes) available from RDT.
ECG cables can be used with conventional disposable pre-gelled electrodes (not supplied) for ECG
monitoring and alarming.
3.3.4 Impedance pneumography
Impedance pneumography operates by continuously measuring changes in the impedance of the patient’s
body. This is done using the two or more ECG electrodes and thus allows the device to measure the
patient’s impedance through the chest. Impedance is measured using a low-current, high frequency
alternating current signal. As the patient breathes, the chest expands and contracts giving a rising and
falling impedance reading. The Tempus measures the time between successive peaks and troughs of the
impedance measurement and translates the time into an interval or rate of respiration.
The impedance method is an indirect measurement of respiration and is also subject to muscle noise and
electrode placement and therefore is inferior to the respiration rate measurement provided through
capnography.
3.3.5 End tidal CO2 (ETCO2) and respiration rate
Tempus uses Microstream® non–dispersive infrared (NDIR) spectroscopy to continuously measure the
amount of CO2 present at the end of exhalation (EtCO2) and the Respiratory Rate.
Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared light. Since
absorption is proportional to the concentration of the absorbing molecule, CO2 concentration can be
determined by comparing its absorption to that of a known standard.
The Microstream® EtCO2 consumables deliver a sample of the inhaled and exhaled gases from the ET tube
adaptor or directly from the patient (via an oral/nasal cannula) into the monitor for CO2 measurement.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 32
3.3 Theory of operation
Moisture and patient secretions are extracted from the sample, while maintaining the shape of the CO2
waveform.
The 50 ml/min. sampling flow rate reduces liquid and secretion accumulation, decreasing the risk of
obstruction in the sample pathway in humid ICU environments.
Once inside the Microstream® CO
microliters). This extremely small volume is quickly flushed, allowing for fast rise time and accurate CO
sensor, the gas sample goes through a micro-sample cell (15
2
2
readings, even at high respiration rates.
The Micro Beam IR source illuminates the micro-sample cell and the reference cell. This proprietary IR light
source generates only the specific wavelengths characteristic of the CO
compensations are required when different concentrations of N
O, O2, anaesthetic agents and water vapour
2
absorption spectrum. Therefore, no
2
are present in the inhaled and exhaled breath. The IR that passes through the micro-sample cell and the IR
that passes through the reference cell are measured by the IR detectors. The microprocessor in the monitor
calculates the CO
concentration by comparing the signals from both detectors.
2
3.3.6 Temperature
Two channels of contact temperature are measured through two sockets on the Tempus. These sockets are
compatible with YSI type 400 probes only. A range of third-party YSI 400 series compatible transducers
may be used with the Tempus. These transducers may be re-usable or disposable.
The Tempus measures temperature by measuring the changing resistance in the tip of the transducer.
When a transducer is correctly attached to the Tempus and to the patient e.g. in the rectum or axilla, the
Tempus obtains a constant (“direct”) reading of resistance that equates to the temperature at that site.
There is no offset or reference body site. The device contains a self-checking system which checks the
thermometer against a known (internal) reference point (every second). If this cross-check fails at any time
the thermometer will be disabled and an error posted on the display.
The thermometer’s reading can be presented in ºC or ºF.
3.3.7 Invasive pressure
Two channels of invasive pressure are measured through a socket on the Tempus. An interface cable is
required to be attached to this socket, the interface cable splits into two ends, each of which can be
connected to a third-party pressure transducer (with a sensitivity of 5 µV/V/mmHg). A range of third-party
transducers (both reusable and disposable) are available. A list of compatible sensors is provided in section
14.8. A different interface cable is required to adapt the Tempus’ socket to the specific connectors of each
type of transducer.
The Tempus measures pressure by measuring the changing resistance in the transducer. When a
transducer is correctly attached to the Tempus and to the patient’s blood stream e.g. in the pulmonary
artery, the Tempus obtains a constant reading of resistance that equates to the systolic and diastolic
pressure. From this mean arterial pressure and heart rate are also calculated.
The option to use two additional channels invasive pressure measurement is provided by an external USB
IP Module. The 2 Channel IP Module can be located adjacent to the Tempus Pro or clipped onto a new
feature on the rear clip. There is no setup required to connect the USB device to the Tempus Pro, other
than plug the USB cable in. The Tempus Pro will automatically recognise that the module is attached.
3.3.8 Controls and indicators
The controls and indicators are divided into three types, items on a touchscreen, membrane buttons and
LED indicators. The Tempus Pro can be operated with or without gloves.
Note
Note
Touchscreen and membrane buttons should be pressed once. As with all touchscreens if
your finger wavers or quivers, the Tempus Pro may register it as more than one press.
To display ultrasound and video laryngoscopy images on the Tempus Pro's large colour
display, you can use third-party ultrasound probes and video laryngoscopy accessories. For
more information, see the Tempus Pro Ultrasound Supplement Guide and Tempus Pro
Laryngoscope Supplement Guide.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 33
Chapter 3 Introduction to the Tempus Pro
3.3.9 Summary Record of Care / Tactical Combat Casualty Care
The Tempus contains an electronic patient record card known as a Summary Record of Care (SRoC). This
is completed semi-automatically through the collection of vital signs and the use of the Event button. SRoC
allows the user to record patient trauma details and to review historic events and trends.
SRoC is automatically augmented with patient encounter data when:
An arrhythmia alarm is triggered. The Tempus Pro automatically logs an event. You can also store a
snapshot of the waveform at the same time, see the All Alarms menu.
A waveform snapshot is manually captured. To capture a waveform at any time, press and release the
Camera & Waveform Snapshot button.
A 12 Lead ECG is recorded.
A camera or laryngoscope image is recorded. For laryngoscope details refer to Tempus Pro
Laryngoscope Supplement Guide.
An ultrasound image is recorded. Images can be taken during general and FAST exams. Refer to
Tempus Pro Ultrasound Supplement Guide.
Tempus Pro can also be configured to record a Tactical Combat Casualty Care (TCCC) card (this feature
only applies to Tempus units configured with the TCCC patient report type); for details see “9.3.2 Updating
the TCCC card”.
3.3.10 Previous activity button
The Previous Activity button allows the user to return to the last non-monitoring function that they were using
i.e.:
TCCC card
Summary Record of Care
Enter patient details
Discharge patient
3.3.11 Trends
All vital signs are captured on the device. These can be easily viewed as a graphical or tabular trend. Also
included in the trends are all alarm states and Events.
3.3.12 Data handover
The Events, Trauma Record and Trend data (as well as photos and 12 Lead ECGs) are automatically
collated together to form a Summary Record of Care patient report. This can be exported from the Tempus
via USB and handed to the next caregiver within the care path. Should the next caregiver have a Tempus
Pro, the data may then be viewed and augmented on that unit. Alternatively, the data may be viewed on
any computer that is capable of reading .PDF files.
3.3.13 Email
An encrypted PDF formatted Summary Record of Care can be shared using email. Encryption and data
transfer are performed using FIPS- 140-2 compliant technology.
3.3.14 ePCR export
Summary Record of Care data can be exported to an electronic Patient Care Reporting system (ePCR).
Encryption and data transfer are performed using FIPS- 140-2 compliant technology. This feature is
optional.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 34
3.3 Theory of operation
3.3.15 Communications
GPS
The Tempus contains a Global Positioning Satellite (GPS) receiver. This can be used to detect signals from
multiple geostationary satellites to obtain a location (expressed in terms of longitude and latitude). The GPS
receiver needs a clear view of the sky to work and so must be used outside.
Digital camera & waveform snapshot
A miniature digital camera is mounted in the unit. Still photos of the patient can be taken which are then
automatically added to the patient record.
Photos can be transmitted to a Response Centre at the time (if the device is connected to a Response
Centre) or transmitted later. In addition, if the Tempus is connected then live moving video can be
transmitted (one way from the Tempus to the Response Centre). This enables the user to show to
colleagues the patient and what is happening to them.
The Camera & Waveform Snapshot button is a two function key. Pressing the button will record the
previous ten seconds and the following ten seconds of the waveforms for review. Pressing and holding the
button will take you to the Camera & Video Options Menu.
Long range voice and data communications
In addition to being able to operate as a vital signs monitor, the Tempus Pro can optionally transmit all of its
measurements via a communications link to a Response Centre. The device allows the Response Centre to
see exactly what is on the Tempus’ display in real time. Therefore, the Response Centre user can see what
the patient’s vital signs are, if they are in an alarm condition etc. In addition, the Response Centre user can
control the device remotely (except for the alarm controls on the membrane keypad which are not provided
to the Response Centre user).
The Tempus also allows the user to talk to the Response Centre user via a wired or wireless headset.
The user at the Response Centre is able to receive still photos from the device and is also able to annotate
these pictures (with words, symbols and markings) and send back to the Tempus device to better illustrate
the verbal instructions being given to the operator at the remote location. The Response Centre user can
also receive moving video from the Tempus.
The Tempus Pro can connect over either wired or wireless (WiFi) Ethernet networks.
All data, voice and video that is transmitted can be secured using FIPS- 140-2 compliant encryption
technology.
If the device is connected to a Response Centre, then all the readings are transmitted via a communications
link to a computer at a Response Centre which enables the user there to see exactly the same information
that is being displayed on the device in real time. The only exceptions to this are when a 12 Lead ECG is
being monitored or recorded and when a still photo is being taken – in both cases the data (ECG or picture)
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 recordings – 1 minute
Digital picture – up to 30 seconds
Note
Note
These times are for guidance only and are based on the use of a 64kbaud or greater
connection. Real time data and waveforms are transmitted with up to a 5 second delay.
RDT recommends that users perform a test connection to the Response Centre every
month in order to verify that their communications remain open for the Tempus to use.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 35
Chapter 3 Introduction to the Tempus Pro
Bluetooth® communications
The Tempus is fitted with a Bluetooth® radio. This enables it to communicate with other Bluetooth® enabled
devices. The Tempus can be provided with an optional Bluetooth headset for providing voice
communications.
3.3.16 On-screen user instructions
The Tempus provides the user with a conventional vital signs monitoring user interface. It can also be set to
provide additional on-screen instructions in the form of text and graphics. This is called iAssist mode. It is
intended for use by a trained healthcare professional, who may benefit from additional instructions on how to
attach the monitor to a patient. It is assumed that a more skilled or experienced user will turn the iAssist
feature on before handing the device to the more junior colleague.
iAssist is intended to make the device easier to use, provide on-screen instructions and provide context
sensitive errors in order to help the user apply the device. It does not change the behaviour of the patient or
technical alarms except to provide more on-screen and graphical instructions in some cases.
Using iAssist means that the format of the results (Home Screen) changes from a 4 channel (2 ECG,
Plethysmogram and Capnogram) layout to a 3 channel (1 ECG, Plethysmogram and Capnogram) layout.
iAssist instructions are available for ECG monitoring, Non-Invasive Blood Pressure, Pulse Oximetry, Contact
Temperature and Capnography. iAssist instructions are not available for invasive pressure as this process
requires specific training and is surgically invasive. Instructions are not included for use of a 10-wire ECG
cable as this requires specific training.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 36
4 Setting up
4.1 Before deployment
Prior to deployment of Tempus Pro there are settings that user organisations need to configure. Carefully
check all the relevant settings on each Tempus Pro before it is deployed. When deploying multiple units,
you may set up a single unit and export the configuration from one unit to the others (cloning the settings).
Three types of configuration are exporting and imported:
events (summary record of care);
new patient defaults;
settings.
Summary record of care events include:
summary record of care assessment, intervention, drug and fluid events;
summary record of care injury and burns body map tags;
summary record of care general screen events selection.
New patient defaults include:
patient alarm limits for all parameters;
default patient mode (adult, paediatric or neonate);
alarm silence and suspend times;
default NIBP settings (mode, auto-time and inflation pressures);
default ECG settings (HR/PR source, ST/QT etc.).;
printer default settings.
Settings include:
communications settings (e.g. IP address);
communications menu;
email settings;
ePCR settings;
patient record type, language, passwords.
Note
Note
Note
Configuration needs to be carried out by a biomedical engineer or suitably qualified person
following the instructions in the Tempus Pro Configuration Utility User Guide.
The unit name is not cloned from one device to another.
Licensed options and enabled features are not cloned from one device to another.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 37
Chapter 4 Setting up
4.2 Unpacking the Tempus Pro
The Tempus Pro is supplied from the factory in protective outer packaging. No special precautions are
required when unpacking the Tempus Pro. RDT recommends that you keep the packaging.
RDT recommends that the equipment is inspected and tested on receipt to confirm that the unit has not
been damaged and that all expected items and accessories have been received and are in working order.
New batteries should be charged up for at least 4 hours on receipt.
Users should ensure that all expected items are received with the Tempus when first opening the delivery
case.
The Tempus Pro
As detailed in section “1.6 Features list”, the Tempus Pro is supplied in a number of configurations. Confirm
that all items ordered have been received.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 38
4.3 Starting and stopping the Tempus Pro and selecting a patient
To ensure that the Tempus Pro is sa
fe to use when colleagues are using NVGs (night
The Tactical Switch is intended for use by
military and civilian pre
-
hospital care users
4.3 Starting and stopping the Tempus Pro and selecting a patient
4.3.1 Switching on
WARNING
Ensure the latches on both sides of the battery are fully engaged prior to using the
Tempus - an incorrectly fitted battery could result in the Tempus losing power during
use.
CAUTION
Do not press any of the controls until the Tempus has started.
To switch on the Tempus Pro, press and hold the button on the front panel for 1
second. The LED on the button will flash green. The device is ready for use when
the LED shines green constantly.
When the Tempus starts it will briefly light the alarm bar and sound the patient alarm. This is to demonstrate
that these functions are operational and must be checked by the user (with the tactical switch off).
4.3.2 Tactical mode (optional)
WARNING
vision goggles), use only the settings in the green shaded NVG areas of the Tactical
Menu: LED Indicators set to off, Brightness set to Min, Low or Mid.
WARNING
for scenarios where low emitted light and low emitted sound is required or desired.
Users are reminded that while these functions are enabled, the device will not emit
visual alarms from the alarm bar, will not emit audible alarms from the speaker and
may present a display that may be too dim to see in daylight conditions. Users
should therefore ensure that they use these features only when required and
recognise that greater levels of patient care and supervision will be required.
It should be noted that the Tempus may be started in a low emitted light and silent state by using the
Tactical switch on the right hand side of the device.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 39
Chapter 4 Setting up
Mode
Tempus Pro Tactical Switch
When the switch is set closest to the symbol the Tempus will start in the following configuration:
All alarm LEDs off;
All audible signals off;
Wireless functions (if enabled by configuration) off;
Display set to mid brightness and standard contrast mode.
In this condition, the following menu of display options will be shown:
Press here to
turn alarm
sounds back on
Press here to
turn on High
Contrast
Press here
to turn on
individual
wireless
devices
Tempus Pro Display Tactical Menu
Press here to
turn LEDs back
on
Press here to
select the
desired
brightness
Press here to
confirm the audio
and visual
settings and
close the dialog
Note
To toggle high contrast, press and hold the Display button for two seconds.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 40
4.3 Starting and stopping the Tempus Pro and selecting a patient
Note
Note
Note
Toggling the Tactical Switch will immediately return the display settings to their previous
configuration i.e. display brightness, all LEDs active, alarms set to the default level and high
contrast off.
The Tactical Switch disables the ac power and charging LEDs; these are only re-enabled
using this switch.
The battery charge LEDs are not disabled using the Tactical Switch.
4.3.3 Setting the patient
WARNING
When the Tempus is turned on, it will ask if it is monitoring a new or previous patient. If the Select Previous
Patient option is pressed, the Tempus will show all patients monitored in the last 72 hours i.e. any patients
whose monitoring started within the last 72 hours.
If any patients have been monitored in the last 72 hours, then the dialog will also include (shown below) an
option to select the last patient that was monitored.
Ensure that you select the correct patient record. Records can be identified by patient
name (last and first), ID number, or incident start time. If you are not sure if the
record you wish to select is the correct one, then select new patient. Mixing different
patient’s records could lead to confusion and misdiagnosis.
Press here to
confirm that the
Press here to
confirm that the
Tempus has
same patient as
before is being
monitored
been put onto a
new patient
Press here to
switch to a
previously
monitored
patient
Patient type is defined as Adult, Child (paediatric) or Neonate. For more information on these groups and
how to select them, see “9.3.5 Entering patient details”.
4.3.4 Starting and stopping iAssist
The iAssist function gives additional on screen instructions for:
Using the ECG
Taking non-invasive blood pressure readings
Taking blood oxygen readings
Taking C0
2
readings
Taking temperature readings
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 41
Chapter 4 Setting up
To switch it on or off:
1. Press the Main Menu button .
2. Slide the iAssist switch to On or Off. When switched on, iAssist buttons appear at the bottom of the
home screen.
4.3.5 Switching off
Before switching the Tempus Pro off, you should make sure that it is not in use.
To power off quickly with no countdown or confirmation:
1. Ensure the Tempus Pro is not in use.
2. Press and hold the button for 2 seconds.
To power off with countdown and confirmation:
1. Ensure the Tempus Pro is not in use.
2. Press and release the button. The LED on the on/off button will start flashing.
3. The Tempus Pro displays a 10 second countdown timer.
Press the Confirm Power Off button.
The dialog
shows a 10
second
countdown
before power off
is aborted.
To confirm
power off, press
here within 10
seconds.
Power Off Dialog
Note
Note
Note
Before removing the battery, you must switch off the Tempus Pro by pressing the power
button. Do not remove the battery when the Tempus is on (unless there is a power supply
attached to the device).
If necessary, you can force a hard shut-down by pressing and holding the power button for
10 seconds.
Remember that the battery cannot be removed until the lamp on the front panel has gone
out.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 42
5 Using the Tempus Pro
The Tempus can be used laying on its back or standing on its foot.
5.1 Controlling the Tempus Pro
Touchscreen
Membrane
buttons
Tempus Controls
The Tempus can be controlled through two different control interfaces. These are:
The touchscreen;
The graphically labelled membrane buttons.
5.1.1 The touchscreen
Note
Take care to press the touchscreen once for any control. Users should press the controls
firmly with a finger (gloved or bare skin can be used). Pressing the touchscreen lightly can
lead to “double presses” if the user’s finger wavers or quivers. If the touch screen is
pressed twice in quick succession and there is a control in the same area where the finger
pressed after the first control would have disappeared (if the screen changes etc.) then the
Tempus will register the second press as activating the second control before the control
appears.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 43
Chapter 5 Using the Tempus Pro
When the device is started it will present as follows:
4 parameter
channels are
provided. These
are labelled and
colour coded to
the patient
connectors on
the side
No patient
sensors have
been connected
yet so this is
indicated for
each parameter
Pressing any of the parameter areas will access the controls and settings menu for that parameter. For
example, if the ECG area is touched, the following menu will be shown:
The Home Screen at Start up
Vital signs
readings are
displayed in
these areas
alongside alarm
limits (if
applicable)
Each parameter
area is a button
which can be
pressed to
access the
settings for that
parameter
The current
measurement is
always shown
here
Real-time vital
signs are
shown across
the bottom
ECG Settings Menu 1 of 2
The parameter
alarms can be
turned off and on
here
All alarm settings
can be accessed
here
Graphical and
tabular trends
can be accessed
Press here to
return to the
results screen
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 44
5.1.2 Membrane buttons and LED indicators
Display
Patient
The Tempus can be controlled through the following membrane buttons:
The On/Off button – pressing and holding down this starts and stops the Tempus –
see “4.3.1 Switching on”.
The Alarm Suspend button – pressing this latches all alarms off for 2 minutes (factory
default – this is configurable by the operating institution) – see “7.6 Silencing or
suspending alarms”.
The Alarm Silence button – pressing this stops any audible alarm signals for 2
minutes (factory default – this is configurable by the operating institution) from
monitoring parameters (and clears alarm signals from discrete measurements such as
non-invasive blood pressure – see “7.6 Silencing or suspending alarms”.
The Home button - this returns the unit to the results screen
The Data Input/Output button – pressing this launches a menu which offers options
on outputting data to peripherals such as printers or USB memory sticks – see “9.1
Data input and output”.
Note that pressing and holding the Data Input/Output button for 2 seconds will
automatically launch the function that is shown at the top of the Data Input / Output
menu. This acts as a short cut to make activating this function easier.
5.1 Controlling the Tempus Pro
The
options – see “9.2 Display options”.
Note that pressing and holding the Display button for 2 seconds will automatically
switch the display mode into a high contrast mode (black on white) for use in strong
daylight conditions. This acts as a short cut to make activating the high contrast
display easier.
The
see “9.3 Patient information”.
Note that pressing and holding the Patient Information button for 2 seconds will
automatically launch the function that is shown at the top of the Patient Information
menu. This acts as a short cut to make activating this function easier.
The Connect button – pressing this will bring up instructions on how to connect the
device to a Response Centre to transmit voice, data and images in real time – see “9.6
Connecting to an alternate location”.
The Disconnect button – if the device is connected to a Response Centre (i2i
ReachBak only), pressing this will bring up a 10 second countdown after which the
voice and data connection will be dropped – see “9.6 Connecting to an alternate
location”.
button – pressing this launches a menu which offers a range of display
button – pressing this allows the user to manage the patient information –
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 45
Chapter 5 Using the Tempus Pro
Camera & Waveform Snapshot
The
waveform capture, pressing and holding will start the camera – see “8 Summary
Record of Care”.
Note that certain events will cause the Tempus to capture a waveform automatically –
see “8.1.4 Automatic event capture”.
Note for devices with software revisions earlier than v4 this button will only perform the
camera function. Please contact RDT for software updates.
The Main Menu button – pressing and releasing this will take you to a full menu to
access all features of the product – see “5.2.1 The main menu”.
The Event button – brings up the Summary Record of Care (SRoC) and provides
access to trend graphs, trend tables and the TCCC card (if configured).
The Previous Activity button – pressing this will take you back to whatever nonmonitoring function you were last performing.
For example, this button could be pressed to take you back into the trauma card if you
had been editing it and a patient alarm had gone off – see “3.3.10 Previous activity
button”.
The battery gas gauge button – pressing this will light the power status LEDs on the
battery – see “11.1.1 The battery”.
button – pressing and releasing this starts the
Also on the membrane are two LEDs, these are indicators and not a button, their function is described
below:
Mains power LED – lights solid green when the mains charger is attached
Battery charger LED – flashes green for up to 20 seconds when a battery is first
connected and the device is being run from mains power, then lights solid green as
long as mains power is attached and the battery is not fully charged – see “11.1.3
Charging the battery”.
5.1.3 Status bar
The status bar at the top of the screen shows the time, battery status, communications status and alarms
status – see “7 Alarms”.
The current patient name and patient type appears in the centre of the status bar until any wired or wireless
communications devices are being used then this will be shown in the centre of the status bar.
The time and battery
status are shown on
the left
This area is used to display information related to
sending the Summary Record of Care report,
connection status including connection to the
Response Centre and the patient name / patient type.
Alarm status
information is shown
on the right
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 46
The Status Bar
5.1 Controlling the Tempus Pro
Battery status indicator
The battery status indicator in the status bar shows the percentage of battery charge remaining:
Icon Status Indication/Action
Battery charge remaining: 51% - 100%.
Green, no flash
Green with flash
Orange, no flash
Orange with flash
Tempus Pro battery is not currently charging.
Battery charge remaining: 51% - 100%.
Tempus connected to mains power (charging in progress).
Battery charge remaining: 26-50%.
Tempus Pro battery is not currently charging.
Battery charge remaining: 26-50%.
Tempus connected to mains power (charging in progress)...
Red, no flash
Red with flash
Unknown battery status
Note
The battery charge can always be checked by pressing the battery gas gauge button, even
when the Tempus is switched off – see “11.1.1 Checking the charge of the battery”.
Battery charge remaining: 0% - 25%.
Tempus Pro battery is not currently charging: connect it
immediately!
Battery charge remaining: 0% - 25%.
Tempus connected to mains power (charging in progress).
Tempus cannot communicate with battery. Check the following:
Is the battery fitted?
Are the battery clips fully engaged?
Are the battery contacts clean and undamaged?
Is the battery in deep discharge state?
For more information, see “11.1.1 The battery”.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 47
Chapter 5 Using the Tempus Pro
Note
5.1.4 Status bar for communications
The centre section of the status bar shows if any communications features are being used. If any
Bluetooth® devices are in use, then the Bluetooth
®
symbol will be shown and along with the number of
peripherals that are connected to the device.
It does not identify the specific peripheral connected to the Tempus Pro.
If a WiFi connection is in use, then this will be shown.
If an external Invasive Pressure module is attached, then this will be shown.
The information displayed in the communications area of the status bar is based on the following priorities:
Email – highest priority
Response Centre communication
Patient name & type – lowest priority
Email status bar messages
When the Summary Record of Care is being shared using email, the upper part of the status area is used to
display the connection progress whilst the lower part of the status area is used to indicate the progress
related to the Summary Record of Care report creation and sending.
The connection progress messages (upper part) may be:
Network Connecting
<Carrier name> e.g. Vodafone UK (only in GSM mode)
Network Connected (only in Wi-Fi or Ethernet modes)
The SRoC report progress messages (lower part) may be:
Creating Report
Sending Report
Report Sent (displayed for 30 seconds after completion)
In this example, an Ethernet
connection has been made
and the SRoC report is
being created
Status bar when SRoC report is shared via email
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 48
5.1 Controlling the Tempus Pro
and if WiFi is being used
Response Centre (i2i) communication
If a data connection is in progress this will be shown. The green icon will flash when the connection is in
being established and the text will read “Data connecting”. When a link to the data centre (gateway) has
been made the icon will stop flashing and the text will read “Data connected”. At this time the Tempus will
be connected to the data centre (gateway) but will not be transmitting any patient data until a Response
Centre user initiates the connection from their terminal. Once they have done this the text will read “Data
Connected”.
Note
If a voice connection has been initiated, then an additional green icon will appear with the text “Voice” next
to it. The icon will flash while the voice connection is being established and will stop flashing once the call
has been picked up by the Response Centre. If video is being transmitted this will be shown.
This section shows if
Bluetooth devices are
attached (and how many), if
video is being transmitted
To transmit data, you must have a manned Response Centre who have the i2i software
installed and who have familiarised themselves with its operation. Full installation
instructions are provided with the i2i software and support is available from RDT, see “RDT
contact details”.
This section shows if data is
“connecting” (dialling), “connected”
(connected to a data centre/gateway)
or “Connected” (connected to a
Response Centre)
Status bar when response centre communication is established
This section shows if voice is
connecting (the icon will flash)
or connected (the icon will be
solid)
5.1.5 Instrument readings
When the Tempus is in use each area will become populated with data. For ECG, Pulse Oximetry, Contact
Temperature, Invasive Pressure or Capnography the data will begin to appear on the display as soon as the
parameter is connected i.e. there is no start control or button for these parameters.
Since the non-invasive blood pressure measurements are single readings this requires the user to both
attach the cuff to the patient and start the reading. These readings are therefore time-stamped with the time
that they were recorded.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 49
Chapter 5 Using the Tempus Pro
5.2 Menus
5.2.1 The main menu
If ever you are unsure of what to do, press one of the following membrane buttons:
The Main Menu button - this will take you to a full menu to access all features of the
product.
The Home button - this returns the unit to the results screen.
At the top of
the screen is
status
information
Labelled
buttons are
provided to
access menus
and features
The menu is
spread over four
pages, you can
Structure of the Main Menu
scroll through
these by pressing
the up and down
arrow
The All Alarms
button opens a
single menu
where all alarms
can be viewed
The Trends
button accesses
trend data
The Back button
takes you back to
the Home screen
or to the previous
menu you were in
CAUTION
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 50
The Quick Start Guide is intended to provide field-based users with summary information
only. It does not replace the need to read this User’s Manual or any other device labelling
and does not replace proper training on the device.
The Main Menu allows access to the following features and controls:
Menu option Menu screen
TDL Settings – for use with the Tempus ALS
system.
Quick Start Guide – pressing each
numbered button will take you through a
series of graphics which explain the features
of the device.
Medical Parameter Settings – open a menu
from which all medical parameter settings can
be accessed, see “6 Taking medical
readings”.
Summary Record of Care - performs the
same function as the Event membrane
button, see “3.3.9 Summary Record of Care /
Tactical Combat Casualty Care”.
Waveform Snapshot - performs the same
function as pressing and releasing the
membrane button, see “5.1.2 Membrane
buttons”.
Display Menu – performs the same function
as the membrane button, see “9.2 Display
Note: The All Alarms and Trends buttons are
present on all pages of the Main Menu, see:
“7 Alarms”
“8 Summary Record of Care“
options”.
5.2 Menus
Patient Menu – performs the same function
as the membrane button, see “9.3 Patient
information”.
Data Input / Output Menu – performs the
same function as the membrane button, see
“9.1 Data input and output”.
Previous Activity - performs the same
function as the membrane button, see “3.3.10
Previous activity button”.
Camera – performs the same function as
pressing and holding the membrane button,
see “9.4 Digital camera”.
Home – performs the same function as the
membrane button.
IAssist – turn iAssist on or off, see “9.7
iAssist processes”.
Note: Switches are provided to turn functions on
and off, e.g. iAssist here.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 51
Chapter 5 Using the Tempus Pro
Communication Modes
Power and Clock Settings
Menu option Menu screen
– configure the
modes, see “9.6.4 Communications modes”.
Wireless Enabled – disable or enable all
wireless communications. If any of these
features are not enabled (either not
purchased or disabled in the device’s
maintenance settings) then they will be
greyed out.
Connect – performs the same function as the
membrane button, see “9.6 Connecting to an
alternate location”.
Manage Wi-Fi Networks – provides access
to the Manage Wi-Fi Networks menu. GPS
Location – obtain a fix on the device’s
location (using the built-in GPS module), see
“9.5 GPS location”.
– provides
access to screen brightness, time, date and
power saving settings, see “5.2.3 Power and
clock settings”.
Maintenance and Settings – open the
Maintenance and Setting Menu. This allows
unit name and mode network settings to be
modified, see the Tempus Pro Maintenance
Manual (available from RDT).
Demonstration and Training – review and
update the demonstration settings, see “13.1
Demonstration and training”.
About Tempus Pro – view device
identification data and a list of features
installed on Tempus Pro, see “9.8 View
installed features”.
Printer and Headset – open the settings for
the communications interfaces of the product,
see “5.2.2 Printer and Headset menu”.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 52
5.2 Menus
5.2.2 Printer and Headset menu
The current unit configuration can be viewed by accessing the Configuration screen from the Printer and
Headset menu – see “5.2.1 The main menu”.
The Printer and Headset menu allows access to settings and controls that the user may occasionally need
to access. Note that the primary communication settings are designed only to be controlled by maintenance
staff so these settings are only available behind the maintenance menu function in the main menu.
The menu allows access to the following functions:
Menu option Menu screen
Pairing Bluetooth – provides step-by-step
instructions on pairing the device.
Headset Settings – update the headset’s
noise filter setting (applicable only to the
Bluetooth headset) and change the default
headset between wired and wireless.
External Printer Settings – choose the
default printer paper - either US Letter (8.5 x
11“) or A4 - and switch between PCL3 &
PCL3-GUI printer types.
Internal Printer Settings – only available if
the Tempus Pro is fitted with a printer.
Change internal printer settings, for example
paper type (plain or grid) and auto print
snapshots (on or off). See “9.9 Printer
maintenance”.
5.2.3 Power and clock settings
Using this menu, you can set the power save mode and the screen brightness level. For details relating to
the brightness setting, see “9.2.5 Brightness control”.
This menu is accessed using the Power and Clock Settings button on the Main Menu – see “5.2.1 The
main menu”.
Menu option Menu screen
Power save mode – turn power saving on or
off.
Brightness – select the screen brightness
level.
Note: The current time and date are also
displayed.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 53
Chapter 5 Using the Tempus Pro
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 54
6 Taking medical readings
WARNING
The Tempus Pro is rated as being proof against the
effects of a d
efibrillator
Note
When a medical module is first started the word “initialising” may appear for a few seconds
in the results area associated to the medical parameter being started.
6.1 Electrocardiography (ECG)
The Tempus Pro allows the user to either monitor the patient’s ECG or take a diagnostic recording of their
ECG (this is an optional feature). This section will explain how to use both features. The device defaults to
ECG monitoring with either a 3-lead, a 4-lead or a 5-lead cable.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
The ECG device is not intended for use in a sterile environment. Do not use for direct
cardiac application.
The ECG device is reusable, other than disposable single-use electrodes.
Do not attempt to insert the ECG device (including patient cables) into an electrical
outlet.
The ECG is for resting recordings and should not be used in stress testing
environments.
Ensure electrodes are connected only to the patient.
Conductive parts of electrodes and connectors, including neutral electrode, should
not contact other conductive parts including earth.
During ECG recordings, ECG alarms are not active and will only be reactivated once
monitoring is resumed.
discharge. Follow these warnings if using an AED or defibrillator with the Tempus
Pro:
Follow the instructions of the defibrillator or AED when using it with the Tempus Pro.
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.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 55
Chapter 6 Taking medical readings
The Tempus Pro is protected against defibrillator discharge but rate meters and
The
Tempus Pro may not operate effectively on patients who are experiencing
convulsions or tremors, or who are moving or are in motion (transport) environments.
Always set the Tempus Pro
to
the correct patient
age
to ensure the QRS detector is
Do not touch the patient, bed, or any conductive material in contact with the patient
during defibrillation.
WARNING
displays may be temporarily affected during defibrillator discharge but will rapidly
recover.
WARNING
In such cases remember to use best practise for electrode site selection (torso rather
than limbs), site preparation (cleaning/scrubbing with an alcohol wipe) and cable
securement at the sensor site and as much as possible along the cable’s length. In
motion environments the Tempus should be secured using a clamp or strap and to
obtain the best possible readings the device should be damped to reduce shocks or
vibrations if possible.
WARNING
The Tempus is not for direct cardiac application.
WARNING
Do not use electrodes of dissimilar metals.
WARNING
set to detect appropriate R wave amplitudes. Per AAMI EC 13, the Tempus uses the
definitions of patient age provided as follows:
Neonate – Children 28 days old or less if born at term (based on 37-week gestation),
otherwise up to 44 gestational weeks.
Paediatric (Child) – Children of 29 days up to and including 12 years old.
CAUTION
CAUTION
CAUTION
CAUTION
Adult – Individuals 13 years old or older.
Failure to set the correct age may result in the Tempus mis-detecting R waves and
providing incorrect heart rate values.
Setting the patient age to 8 years or less will mean that the ECG monitor will be set to
detect paediatric R waves per AAMI EC13.
If you do not set the patient age, the Tempus will use the default patient age group
(see the Tempus Pro Maintenance Manual). Ensure that the patient age/type is
always entered for non-adult patients – see “9.3.5 Entering patient details”.
As the following sections will explain, the Tempus Pro will present results in a different
layout depending on whether the device is set to ECG monitoring or Diagnostic ECG. The
alarm functions will be the same in either case.
Certain line-isolation monitors may cause interference on the ECG display and may inhibit
heart rate alarms. Users should ensure electrodes are placed correctly, with the skin
prepared in advance as instructed.
The electrodes of the ECG apron must be applied carefully. Follow the electrode
manufacturer’s instructions in the storage, removal and application of the electrodes to the
patient to ensure the electrode is placed optimally.
Care must be taken to ensure that the electrodes do not contact live (electrical) parts or
earthed metal parts of local systems or structures.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 56
6.1 Electrocardiography (ECG)
CAUTION
If the patient is attached to a cardiac defibrillator, care must be taken not to touch any part of
the ECG cables while the patient is being shocked.
Note
Note
The leads and cables of the ECG should be checked for fraying, tears, knots or other signs
of damage before and after use.
Ensure that all labelling including instructions for use, printed warnings and use-by dates
associated with third-party ECG electrodes are adhered to.
6.1.1 Getting started
1. To measure correct R wave values, make sure that the right age group is selected in the patient
details. For instructions, see “9.3.5 Entering patient details”.
2. Make sure that you have read the monitoring standards in "14.1.1 ECG monitoring".
3. Ensure that the ECG cable is properly inserted into the green connector on the Tempus Pro:
4. Prepare the patient's skin at the electrode sites:
Shave or clip excess hair.
Clean the skin thoroughly with an alcohol wipe.
Rub the skin to dry.
5. If the patient has a pacemaker, turn on pacemaker indication:
Press the ECG area of the touchscreen or navigate to the medical parameter setting in the
Main Menu.
Switch Pacemaker indication on.
6. Make sure that the frequency setting matches the frequency of the mains you are using:
Press the ECG area of the touchscreen.
Select the correct Mains power frequency.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 57
Chapter 6 Taking medical readings
6.1.2 Monitoring ECG with a 3-lead cable
By default, the Tempus Pro will be set to ECG monitoring when it is supplied.
ECG monitoring with a 3-lead cable allows the user to monitor Leads I, II or III of the patient’s ECG. ECG
monitoring requires the use of a 3-lead/electrode cable – see “12 Accessories list of the Tempus Pro”.
The 3-lead cable may be pre-attached to the Tempus in the green connector. The Tempus Pro will
automatically detect which cable type is in use. With a 3 electrode cable one lead waveform (I, II, or III) is
available for display at a time.
Electrode Positions for 3-lead ECG Monitoring
The cable terminates in conventional 4 mm snap connections which can be used with various commonly
available disposable ECG electrodes. Two types of cables are provided for compliance with AAMI and IEC
guidelines. For details of cable part numbers, see “12 Accessories list of the Tempus Pro”.
These are labelled:
Position AAMI
Label/Colour
Right mid-clavicular line under clavicle / right wrist RA White R Red
Left mid-clavicular line under clavicle / left wrist LA Black L Yellow
Left hip / left ankle LL Red F Green
Once the electrodes are connected to the patient, the Tempus will begin to display the ECG signals
immediately.
IEC Label/Colour
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 58
6.1 Electrocardiography (ECG)
6.1.3 Monitoring ECG with a 4-lead cable
ECG monitoring with a 4-lead cable allows the user to monitor Leads I, II, III, AvL, AvR and AvF. Up to two
leads can be displayed at any time. Four wire ECG monitoring requires the use of a 4-lead/electrode cable
– see “12 Accessories list of the Tempus Pro”.
The 4-lead cable should be pre-attached to the Tempus in the green connector.
Electrode Positions for 4-lead ECG Monitoring (torso or limbs)
The cable terminates in conventional 4 mm snap connections which can be used with various commonly
available disposable ECG electrodes. Two types of cables are provided for compliance with AAMI and IEC
guidelines. For details of cable part numbers, see “12 Accessories list of the Tempus Pro”.
These are labelled:
Position AAMI Label/Colour IEC Label/Colour
Right mid-clavicular line under clavicle / right wrist RA White R Red
Left mid-clavicular line under clavicle / left wrist LA Black L Yellow
Left hip / left ankle LL Red F Green
Right hip / right ankle RL Green N Black
If the ECG is inoperable then the ECG will either show a “Leads off” error for the specific Lead that is
unavailable or will show a technical error as described in section “7.4 Technical alarms”.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 59
Chapter 6 Taking medical readings
6.1.4 Monitoring ECG with a 5-lead cable
ECG monitoring with a 5-lead cable allows the user to monitor Leads I, II, III, AvL, AvR, AvF or a userplaceable V Lead. Up to two leads can be displayed at any time. Five wire ECG monitoring requires the
use of a 5-lead/electrode cable – see “12 Accessories list of the Tempus Pro”.
The 5-lead cable should be pre-attached to the Tempus in the green connector.
Electrode Positions for 5-lead ECG Monitoring
The cable terminates in conventional 4 mm snap connections which can be used with various commonly
available disposable ECG electrodes. Two types of cables are provided for compliance with AAMI and IEC
guidelines. For details of cable part numbers, see “12 Accessories list of the Tempus Pro”.
These are labelled:
Position AAMI Label/Colour IEC Label/Colour
Right mid-clavicular line under clavicle / right wrist RA White R Red
Left mid-clavicular line under clavicle / left wrist LA Black L Yellow
Left hip / left ankle LL Red F Green
Right hip / right ankle RL Green N Black
This is a moveable pre-cordial electrode. Place it in any
position from V1-6 as follows:
V1 - 4th intercostal space at right sternal margin.
V2 - 4th intercostal space at left sternal margin.
V3 - Midway between V2 and V4 leads.
V4 - 5th intercostal space at mid-clavicular line.
V5 - Same transverse level as V4 at left anterior-axillary
line.
V6 - Same transverse level as V4 at left mid-axillary line.
If the ECG is inoperable then the ECG will either show a “Leads off” error for the specific Lead that is
unavailable or will show a technical error as described in section “7.4 Technical alarms”.
V Brown C White
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 60
6.1 Electrocardiography (ECG)
The picture below shows the Tempus monitoring Lead II and Lead I (using a 5-lead cable). Each ECG trace
is labelled in the top left. The heart rate is shown on the right hand side for the uppermost trace.
Tempus monitoring Lead II and Lead I (using a 5-lead cable)
6.1.5 Monitoring ECG with a 12-lead cable
Diagnostic 12 lead ECG is an option on the Tempus Pro. You can use a standard 12-lead ECG cable or a
12-lead modular cable (a 4-lead cable connected to an additional 6-lead cable). The cable terminates in a
4 mm snap style connector for use with normal disposable electrodes – see “12 Accessories list of the
Tempus Pro”.
To view a 12-lead ECG, the ECG settings must be changed as shown below.
With the 12
Lead cable
connected,
press here to
activate the
12 Lead view
ECG Settings Menu – 12 Lead ECG Selected
If the 12-lead ECG Cable is attached but the 12-lead View is not selected on the screen, then the Tempus
will remain in standard ECG monitoring mode and will continue to show two waveforms on screen.
Two types of cables are provided for compliance with AAMI and IEC guidelines. For details of part numbers
of cables, see “12 Accessories list of the Tempus Pro”.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 61
Chapter 6 Taking medical readings
These are labelled:
Position AAMI Label/Colour IEC Label/Colour
Right mid-clavicular line under clavicle / right wrist RA White R Red
Left mid-clavicular line under clavicle / left wrist LA Black L Yellow
Left hip / left ankle LL Red F Green
Right hip / right ankle RL Green N Black
This is a moveable pre-cordial electrode. Place it in any
position from V1-6 as follows:
V1 - 4th intercostal space at right sternal margin. V1 Red C1 Red
V2 - 4th intercostal space at left sternal margin. V2 Yellow C2 Yellow
V3 - Midway between V2 and V4 leads. V3 Green C3 Green
V4 - 5th intercostal space at mid-clavicular line. V4 Blue C4 Brown
V5 - Same transverse level as V4 at left anterior-axillary
V5 Orange C5 Black
line.
V6 - Same transverse level as V4 at left mid-axillary line. V6 Violet C6 Violet
The electrodes should be attached to the patient as shown below. Before attachment the patient’s skin
should be prepared according to the instructions of the electrodes e.g. cleaning the skin with alcohol and
shaving if necessary.
Remember only to use electrodes which are compliant with AAMI EC12 and to read and follow the
instructions for the electrodes.
Electrode Placement for 12 Lead ECG Monitoring
Once in 12 Lead ECG Mode, the ECG will monitor 12 Leads of ECG.
If the ECG is inoperable then the ECG will either show a “Leads off” error for the specific lead that is
unavailable or will show a technical error as described in section 7.4.
WARNING
When acquiring a 12-Lead ECG, encourage the patient to remain as still as possible.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 62
6.1 Electrocardiography (ECG)
pressing this
In 12 Lead mode, the other vital signs data remain displayed across the bottom of the display. All 12 ECG
Leads are shown in the main display (each Lead is labelled).
The Tempus
will remain
monitoring
the 12 leads
until a 10
second
recording is
started by
Press here to
view previous
The real
time vital
signs are
displayed
here
12 Lead ECG Monitoring Screen
If no signal or a poor signal is seen on one or more leads, the following steps should be reviewed:
recordings
Has the correct cable been used, is it connected properly?
Is the patient still?
Is the equipment setup properly (all electrodes attached)?
Could there be interference from other electrical equipment?
Is the mains filter set correctly (see ECG Settings)?
Are the 12 lead filters set correctly (see ECG Settings)?
Was skin sufficiently well prepared?
Could the electrodes be dry or poorly attached?
6.1.6 Performing a diagnostic ECG
The 12 Lead function enables users to record a 10 second trace for immediate or subsequent analysis and
interpretation.
The 10 second recording will be added to the patient record and therefore can be exported by USB stick to
another Tempus or to a computer to be read as a .PDF file. The ECG can also be transmitted to a
Response Centre if this option is in use – see “9.6 Connecting to an alternate location”.
Making a 12 lead ECG recording
Pressing the Start Record button will initiate a 10 second recording. If the Tempus is connected to a
Response Centre then this will be transmitted as soon as the recording is complete. The Response Centre
has tools for measuring the ECG. Otherwise, the recording can be viewed on screen by using the left and
right arrow keys.
Note
If you inadvertently press Stop Record, you can press Start Record to immediately restart
the recording.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 63
Chapter 6 Taking medical readings
Note
The ECG
recording
can be
scrolled
through
using
these
buttons
12 Lead ECG Recording Screen
If an internal printer is fitted to the Tempus, you can print the 10 second recording using the Print button.
For printer instructions see “9.9.2 Internal printer configuration (optional)”.
If the Tempus Pro is fitted with an internal printer and automatic printing is enabled, it will print waveforms as
soon as they are captured.
ECG interpretation
WARNING
WARNING
WARNING
Note
The Tempus Pro provides ECG interpretation of the 12 lead ECG recordings. This interpretation includes:
Rhythm statements – there are 69 different statements this includes the reporting of detected
Arrhythmias such as Ventricular Tachycardia, Atrial Fibrillation, Extreme Bradycardia, and AV Block
(please see QRS Diagnostic Physician's Guide ECG Analysis for Resting 12-lead ECG for further
information, Part number 630000-00).
All numerical, graphical and interpretive data should be evaluated with respect to the
patient's clinical and historical picture.
ECG interpretation performed by software is not a substitute for review and
evaluation of ECG recordings by a qualified clinician.
Motion artefact or noise in the ECG recording could result in erroneous
interpretations.
Interpretations are unconfirmed and need to be reviewed by a clinician.
ECG interpretation is only available for patients aged 18 years and over. If age is not set,
interpretation will be based on an adult patient type.
Morphology statements – there are 121 different statements including ST analysis which includes over
20 Ischemic ST change statements such as: “Ischemic ST-T changes in posterolateral leads” and
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 64
6.1 Electrocardiography (ECG)
“Ischemic ST-T changes in lateral leads” (please see QRS Diagnostic Physician's Guide ECG Analysis
for Resting 12-lead ECG for further information, Part number 630000-00).
Waveform summary measurements – this includes; QT and QTc interval measurements, PR interval,
QRS duration, P duration, P axis, QRS axis and T axis.
Once a 12 lead ECG has been recorded you can view the ECG interpretation.
Press here
to cycle
through all
ECG
recordings
Press here to
view the
Interpretation
Press here
to see the
summary
page
View ECG Recordings Screen
Press here to
start monitoring
the 12 lead
ECG
Press here
to see the
ECG
recording
ECG Interpretation Screen
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 65
Chapter 6 Taking medical readings
Press here to
go to the ECG
Interpretation
page
Press here to
start
monitoring the
12 lead ECG
Press here
to see the
ECG
recording
ECG Summary Screen
6.1.7 ECG specifications
ECG monitoring specifications
The following disclosures are made in accordance with the requirements of AAMI EC13 and IEC60601-2-27:
The ECG’s display includes the isoelectric segments of the QRS.
For leads off detection, the ECG device applies a 1 kHz triangular wave of approximately 6 mV p-p
between the R/RL and L/LL electrodes
The Heart Rate Detection of the ECG monitor is accurate to +/-10% or +/-5 bpm for a T Wave of
amplitude: up to 1.0 mV.
The heart rate is calculated from the average of the 8 most recent RR intervals. Intervals are logged as
“invalid” if the detections are unreliable, or if detections are absent over the maximum RR interval of 2.4
s. Invalid intervals are counted but not included in the average. If there are no valid intervals in the
most recent 8, then no heart rate is reported. Heart rate is updated with every new valid or invalid
interval.
Further to clause 4.1.2.1e) of AAMI EC13: the system’s response to Fig 3a is 40 bpm ±10% (inverted
QRS are counted). The system’s response to Fig 3b is 30-100 bpm (small QRS are intermittently
counted). The system’s response to Fig 3c is 120 bpm± 10% (all QRS are counted). The system’s
response to Fig 3d is 60-100 bpm (bipolar QRS are intermittently counted).
Electrical noise such as power line transients can cause false heart beat detection which may inhibit
alarms. The problem may be minimized by ensuring good electrode contact. Power system noise may
be reduced by running the monitor from its battery.
The system’s typical response time to change from 80 to 120 bpm is ~7 s, for a change from 80 to 40
bpm is the typical response time is ~7.5 s.
The system heart rate alarm will respond to the specified tachycardia signals of Figures 4a and 4b of
AAMI EC13 within 5-7 s. In some cases, an out of range alarm may be given, with an indication of no
valid heart rate.
The heart rate limit alarm will respond to an out of range condition 0-10 seconds after being activated.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 66
6.1 Electrocardiography (ECG)
Per EC13, 4.1.4.1, heart rate is accurately indicated in the presence of effective pacemaker single
pulses without overshoot, having width of up to 2 ms and amplitude up to 700 mV, and such pulses
alone do not cause heart rate detection. In the case of ineffectively paced QRS, erratic readings may
result for single pulses above 2 mV. Overshoot is specified according to EC13 4.1.4.1 Method B.
Per EC13 4.2.9.12, the muscle filter will make pacemaker pulses appear smaller than 2mm. Switch
muscle filters off (Diagnostic filter setting) to see pacemaker pulses more clearly.
Measurements of the ECG waveform should be normalized against the scale provided. The scale
presents 1 mV as 8 mm with a gain setting of 10mm/mV.
Note that in the 4 waveform view the channel height of the ECG is 24 mm and thus permits a maximum
input signal of ±2.2 mV when using a gain of 5 mm/mV. In the large ECG view a maximum input signal
of ±5 mV is achieved using a gain of 5 mm/mV. Large ECG view is described in “9.2 Display options”.
Compliance with EC12 clause 4.2.9.8 b) (and relevant clause of IEC60601-2-25:2011) requirements for
frequency response are achieved only with the muscle filters switched off (i.e. using the Diagnostic filter
setting).
For leads off detection, the ECG applies a 1 kHz triangular wave of approximately 6 mV p-p between the
R/RL and L/LL electrodes.
The slew rate of the ECG as per AAMI EC13 4.1.4.3 is 3.7 V/s (all filters off).
ECG recording specifications
The following disclosures are made in accordance with the requirements of AAMI EC11 and IEC60601-2-25:
Frequency and impulse response has been evaluated according to methods A, B and C of EC11:1991
3.2.7.2/4.2.7.2. All EC11 tests have been performed using SCP files generated by the i2i software as an
acquisition system. Compliance requires that all optional filters be switched off.
ECG data in this system are contained in computer files, using a proprietary format based on the SCP-
ECG standard. The ECG data are digitized using a sample rate of 500sps and a resolution of
2995nV/bit with 12 bit (4096 level) dynamic range.
Automated measurements of amplitude and duration of QRS complexes generated from the ECG
recording are only valid for adult patients. For younger patients the values should be measured using
the electronic calipers within i2i.
Per clause 201.12.1.101.3 automated measurements of the S segment duration of CAL waveforms are
±15 ms. The automated value can be confirmed using the electronic calipers within i2i
Per clause 201.12.4.107.3 The skew rate is 0
Automated measurements are only able to distinguish T-waves of amplitudes greater than >50 µV
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 67
Chapter 6 Taking medical readings
6.1.8 ECG settings
Pressing either of the ECG trace areas will bring up the ECG settings menu:
Menu option Menu screen
Heart rate limits (bpm) – open the the alarm
limits editor (described below).
Heart Rate Lead – (4-, 5- and 12-lead ECG
only) change which lead the heart rate is
taken from.
Waveform / Lead selection - when using 4-,
5- or 12-lead ECG, press here to customise
the selection of waveforms on the four
waveform display, see “9.2.4 Waveform and
lead selection”.
HR/PR source –select ECG or Pulse
oximeter as the heart/pulse rate source (see
also HR/PR beat volume below).
ECG Gain (mm/mv) –select the desired gain
(or size) of the waveform.
View 12 lead ECG – if the 10 wire (12 Lead)
ECG cable is selected, this option will be
available. Pressing it will bring up a different
display interface that shows all 12 ECG leads.
Note: When using a 3-lead ECG, the heart rate is
derived from the waveform displayed:
Arrhythmia analysis and ST/QT analysis
(on/off) – enable or disable these
measurements.
ST lead selection - when ST monitoring is
active, change the ST leads that are
displayed, see “ST lead selection”.
ST1 limits (mm) – open the editor to change
the ST alarm limits.
ST2 limits (mm) – open the editor to change
the ST alarm limits.
QT upper limit (ms) – open the editor to
change the QT alarm upper limit.
Cardiac wave speed (mm/s) – select the
desired speed of the waveform.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 68
Menu option Menu screen
HR/PR beat volume
– volume of the audible
tone that the Tempus emits every time a
heartbeat is detected. Use the up and down
arrows to adjust the volume from zero (no
tone) to 100%. The tone is based on the
HR/PR source setting (see above): when set
to ECG, QRS beats trigger a single tone at
1 kHz. When set to Pulse, pulse beats trigger
pulse tones – see “6.3.6 Pulse oximeter
settings”.
Pacemaker indication – turning this on will
show a vertical dotted line on the ECG
waveform when the ECG is connected to a
patient wearing a pacemaker.
Monitoring filter – use the arrows to select a
filtering option.
12 lead filter – use the arrows to select a
filtering option.
ECG Power Filter – this is set to ON by
default, switch it off if you wish the ECG to be
presented without the Power noise being
filtered out.
6.1 Electrocardiography (ECG)
ST lead selection screen
First press
ST1 or ST2
Note
The ECG waveforms displayed on the home screen will change to match the selected ST
leads.
ST Lead Selection
Then select the
lead you wish to
be displayed e.g.
Lead III
Lastly press on
Cancel to clear
the changes or
Save & Back to
keep them,
either option will
return to the
ECG settings
menu
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 69
Chapter 6 Taking medical readings
Monitor
Note
The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is
The system can filter out some interference but corrupted or excessively noisy
Note
In order to reduce noise and artefact the Monitoring filter should be set to
Filtered diagnostic and the Mains filter should be switched on. When attached to a mains
power supply noise may be observed on the ECG if these filters are switched off.
or
Consequently, they should be left switched on when operating under mains power or mains
power should be disconnected if the filters need to be switched off.
Users are reminded to have the mains filter frequency set to the correct value (50 Hz or 60
Hz) in order for it to be effective. This should be checked before use.
Mains frequency setting. Hz means Hertz, or cycles per second. In North America, mains electricity
supplies operate at 60 Hz; most of the rest of the world uses 50 Hz. In aircraft the filter should normally be
set to 50 Hz. In remote land and maritime applications, the local voltage could be either 50 Hz or 60 Hz.
ECG systems can pick up interference from mains electricity supplies. This interference appears on the
screen as regular interference patterns.
6.1.9 Detecting arrhythmias during ECG monitoring
During ECG monitoring, the Tempus Pro analyses the 2 ECG waveforms on the home screen to detect
arrhythmias. All results are displayed as text on the results screen.
WARNING
WARNING
WARNING
WARNING
ECG monitoring arrhythmia analysis is a tool to be used in addition to patient
assessment. Care should be taken to assess the patient at all times.
The Automated ECG Arrhythmia Analysis software is designed to be used by
qualified medical personnel.
The clinician and/or medically qualified personnel are responsible for determining the
clinical significance of each detected arrhythmia event or alarm.
The arrhythmia detection feature on the Tempus Pro is not a diagnosis tool and is an
additional tool to support the clinician in their own diagnosis only. The classification
performance of the arrhythmia feature has been tested using the FDA recognised
consensus standard. The analysis algorithm has also been tested and approved in
other products. The monitor cannot be relied upon to detect all arrhythmias. Do not
rely solely on the displayed arrhythmia data and alarms to assess the patient’s
condition. Always observe the patient closely and monitor all of their vital signs
carefully.
WARNING
not designed to detect atrial or supraventricular arrhythmias. The program may
incorrectly identify the presence or absence of an arrhythmia. A physician must
analyse the arrhythmia information with other clinical findings.
WARNING
signals may cause artefacts. If the ECG waveform is too noisy, Noise is displayed on
screen. If no arrhythmias are detected and there is no noise in the signal, Arrhythmia
Analysis On is displayed to ensure the operator is aware arrhythmia analysis is
running.
WARNING
Heart parameters can be affected by the use of drugs. Patient drug use history should
be reviewed when reviewing detected arrhythmia.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 70
WARNING
CAUTION
fibrillation
WARNING
6.1 Electrocardiography (ECG)
For patients with pacemakers, ensure pacemaker indication is turned on.
Arrhythmia analysis is sourced from the ECG signal (including detection of extreme
bradycardia, extreme tachycardia), this is independent of the heart rate display
source selection (ECG or pulse).
Only start arrhythmia learning during periods of predominantly normal rhythm, and when the
ECG signal is relatively noise-free. If arrhythmia learning takes place during ventricular
rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may
result in missed detection of subsequent arrhythmias.
CAUTION
If arrhythmia analysis is not restarted when a template changes:
Inaccurate arrhythmia alarms can be triggered.
Inaccurate heart rates can be recorded.
To optimise arrhythmia detection, select leads with the largest amplitude and the least amount of noise to be
analysed:
1. Turn on arrhythmia analysis in the ECG menu. Arrhythmia detection starts up and performs a
learning period.
2. To change the waveforms being analysed, press Lead waveform selection on the ECG menu and
select the lead required.
3. If a patient's ECG template changes dramatically, turn arrhythmia analysis off and on.
Arrhythmia detection performs a relearning period based on the new template.
An arrhythmia detection relearning period can also be triggered when you:
Change patients
Change Lead waveform selection or Heart rate lead options
The following arrhythmia events are detected and recorded:
Arrhythmia Screen
text
Extreme
bradycardia
Extreme
Brady
Description High priority
patient alarm
triggered
The average heart rate is 5 bpm below the
Yes Yes
low heart rate set on the Tempus Pro (with
a maximum of 60 bpm).
Event /
waveform
capture
Extreme
tachycardia
Extreme
Tachy
The atrial and ventricular rates are equal.
The heart rate is 5 bpm above the high
heart rate limit set on the Tempus Pro (with
a minimum of 100 bpm)
Ventricular
tachycardia
Vent
Tachy
Ventricular HR is greater or equal to the
Tachycardia rate threshold and the number
of PVCs is greater than 6.
Asystole Asystole No QRS complex for 5 consecutive
seconds (in absence of ventricular
fibrillation or chaotic signals)
Ventricular
Vent Fib Ventricular fibrillation occurs and persists
for more than 6 seconds.
A medium priority alarm is triggered when:
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 71
Yes Yes
Yes Yes
Yes Yes
Yes Yes
Chapter 6 Taking medical readings
Some clinica
l conditions may make it difficult to achieve reliable ST monitoring.
For
The ST and QT measurements have
not been qualified for use on paediatric or
The QT algorithm has been tested for accuracy. The significance of the QT segment
During the 10 seconds of an ECG recording ST and QT measurements will stop and
Arrhythmia analysis is turned off, and either the low heart rate or high heart rate alarm limits are
breached.
Arrhythmia analysis is turned on, and either the low heart rate or high heart rate alarm limits are
breached
A high priority Extreme Brady or Extreme Tachy alarm is triggered when the heart rate continues past
already breached alarm limits.
A 20 second waveform snapshot is captured for all arrhythmia events that trigger an alarm – see “8.1 Event
capture”.
6.1.10 Measuring ST elevation and QT interval (optional)
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
ST measurements should always be verified by the clinician and/ or medically
qualified personnel.
best results, consider the following: the ability of the patient to cooperate and be
relaxed. Patients who are restless can produce noisy physiological signals. Noisy
signals which can result in inaccurately high or low data measurements.
QT measurements should always be verified by the clinician and/ or medically
qualified personnel.
neonate patients and are therefore switched off when an age <18 is entered on the
Tempus Pro.
however needs to be determined by a clinician. This feature is to aid the clinician in
monitoring the change in QT only.
The ST algorithm has been tested for accuracy of the ST segment data. The
significance of the ST segment changes however needs to be determined by a
clinician. This feature is to aid the clinician in monitoring the change in ST and not
diagnosing STEMI or Ischemic events.
therefore there may be an additional delay before an ST or QT alarm is triggered if the
alarm limit is breached during a recording.
WARNING
For very high heart rates (>250 bpm) no ST value will be reported.
WARNING
Some arrhythmia conditions may make it difficult to reliably produce ST
measurements.
WARNING
With ECG waveforms with T-waves smaller than 0.1 mV, the accuracy of the QT
measurement may be reduced, therefore select leads with large T-waves.
Note
When using a 3-lead ECG cable only 1 ECG waveform is produced. Therefore, only 1 ST
measurement value can be produced by the Tempus Pro. For optimum monitoring of ST, a
4- or more lead cable should be used so both ST measurements can be reported.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 72
6.1 Electrocardiography (ECG)
The Tempus Pro presents the user ST elevation (+) and depression (-) measurements as well as QT
duration measurements for the electrocardiogram (ECG) monitoring waveform and displays it in numeric
format on the results screen.
The Tempus makes ST and QT measurements on the 2 waveforms which are viewed on the home screen.
These waveforms can be changed using the Lead Waveform selection option on the ECG menu. These
measurements can be performed on any of the lead types available from the ECG cable being used. An ST
measurement for each of the 2 waveforms is reported along with a single global QT measurement value.
The ST measurement is taken between the ECG isoelectric line (PR segment) and a point in the ST
segment. The point taken for measurement is 80 milliseconds after the J point if the heart rate does not
exceed 115 bpm and 60 milliseconds after the J point if the heart rate exceeds 115 bpm. The ST
measurement value is updated every 10s. If the measurement is not available, the display will show “- - - “.
The ST value measured is a voltage; by convention the value is displayed as the equivalent measurement
height for a standard ECG gain of 10mm/mV. In this convention 0.1mV will be displayed as 1.0mm. The ST
measurement height gain is fixed at 10mm/mV and does not depend on the ECG gain setting.
A medium priority alarm will be triggered if the ST alarm limit is exceeded for more than 1 minute and the
value will flash to indicate it is in alarm.
The QT interval is a measurement of the time between the start of the Q wave and the end of the T wave in
the heart’s electrical cycle. The Tempus Pro shows this measurement on the results screen. The QT value is
reported in milliseconds (ms).
A medium priority alarm will be triggered if the QT alarm limit is exceeded for more than 1 minute and the
value will flash to indicate it is in alarm.
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Chapter 6 Taking medical readings
If capnography is used, the Tempus will always obtain
its respiration rate
With any monitor that detects respiratory
effort through impedance pneumography,
Since impedance pneumography uses the same leads as
the ECG channel, the
6.1.11 Monitoring respiration rate with ECG cable
The Tempus Pro allows the user to monitor the patient’s respiration through the ECG cable by measuring
the change in the patient’s impedance as their chest wall moves (impedance pneumography). This section
will explain how to use this feature. The device defaults to impedance respiration being off. By turning
Impedance Respiration on, it can be measured through one ECG lead on 3-, 4-, 5- or 12-lead cables, unless
the Capnometer is in operation.
WARNING
Do not operate the Tempus with any other monitor with respiration measurements on
the same patient. The two devices could affect the respiration accuracy of each
other.
WARNING
Do not use the Tempus as an apnoea monitor.
Respiration rate from ECG leads
By default, the Tempus Pro will be set to monitor respiration rate through the ECG leads when it is supplied.
WARNING
measurement from this parameter. If capnography is not available, then respiration
will be derived from the ECG leads using an impedance-based method. In this case,
users are reminded that the reading represents a cyclic change in measured
impedance which is interpreted to be the change of impedance as the chest moves
out and in. Users should note that this is therefore an indirect reading of respiration.
WARNING
Impedance pneumography detects respiratory effort through changes in chest
volume. However, No Breath episodes with continued respiratory effort may go
undetected. Always monitor and set alarms for SpO
when using impedance
2
pneumography to monitor respiratory function.
WARNING
artefact due to patient motion, apnoea mattress shaking, or electrocautery use may
cause apnoea episodes to go undetected. Always monitor and set alarms for SpO
when using impedance pneumography to monitor respiratory function.
WARNING
When using impedance pneumography, don’t use the Tempus with another
respiration monitor on the same patient, because the respiration measurement
signals may interfere with one another.
WARNING
Impedance pneumography is not recommended for use on paced patients, because
pacemaker pulses may be falsely counted as breaths.
WARNING
Impedance pneumography is not recommended for use with high frequency
ventilation.
WARNING
Tempus unit determines which signals are cardiovascular artefact and which signals
are the result of respiratory effort. If the breath rate is within five Percent of the heart
rate, the monitor may ignore breaths and trigger a respiration alarm.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 74
2
6.1 Electrocardiography (ECG)
CAUTION
Users should note that in the case of supine patients, breathing may involve relatively
greater movement of the abdomen (and consequently less expansion of the chest) during
breathing. In this case chest impedance changes may not be significant to produce reliable
readings.
CAUTION
CAUTION
If impedance respiration is being used, the ECG electrodes should be placed on the torso
and not the limbs.
Impedance respiration measurements are highly subject to patient movement. The
impedance changes across the chest during breathing can be easily masked by patient
movement or muscle noise during movement.
CAUTION
In motion environments care should be taken to observe best practise on electrode site
preparation, electrode and cable securement, securement of the Tempus and securement of
the patient. RDT recommends using capnography to measure respiration in motion
environments.
Impedance-based respiration monitoring is performed through the Lead II wires (RA-LL) by default. This can
be changed to use Lead I (RA-LA). For the most reliable respiration measurement, users should select the
lead which has the largest R-wave. Your choice depends on the ECG cable type connected and the lead
chosen for ECG waveform monitoring:
ECG cable type connected
Lead selected for ECG
waveform monitoring
Leads available for respiration
monitoring
Lead I Lead I only
3-lead
Lead II Lead II only
Lead III Lead I or Lead II
4-, 5- or 12-lead Any
Lead I or Lead II
(independent of ECG waveform)
Note
If capnography is in use, the waveform will automatically change to “CAPNO” and will
display the end tidal CO
. The results will change to additionally display the ETCO2 reading.
2
Once the ECG cable is attached, respiration measurements will be started. The device will produce a
reading once an average of 3 readings has been obtained. Consequently, with very low respiration rates
(e.g. 5 per minute), a reading may not be obtained for 30 seconds or more. The product will as a
consequence also have a slower level of responsiveness to marginal changes in respiration rates with
patients with such low breathing rates.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 75
Chapter 6 Taking medical readings
The
pneumography
(respiration)
waveform is
shown here
The respiration
rate is shown
here
Impedance respiration settings
Pressing anywhere on the Respiration area brings up the Respiration Settings Menu.
Note
Respiration limits (rpm) – set the upper and
lower alarm limits for respiration.
Respiration wave speed (mm/s) – set wave
speed to 3.1, 6.25 or 12.5. This setting is
independent of other waveforms.
Respiration lead – select which ECG lead
will measure respiration rate.
Respiration wave gain – use the up and
down arrows to adjust wave height (gain).
Respiration monitoring – turn impedance
respiration off or on. Use this, for example,
where patient movement is too great to allow
stable impedance measurements to be taken.
If capnography is in use, the waveform shown will be labelled “CAPNO” and will display the
end tidal CO
Menu.
. In this state pressing on the waveform will bring up the Capnometer Settings
2
Menu option Menu screen
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 76
6.1 Electrocardiography (ECG)
6.1.12 Monitoring heart/pulse rate with no leads
If the ECG is not attached to the patient, then the heart rate will be taken from the pulse oximeter if this is
attached to the patient. Otherwise no heart rate will be shown.
Note
If the ECG is inoperable then the ECG will either show a “Leads off” error for the specific Lead that is
unavailable or will show a technical error as described in section “7.4 Technical alarms”.
If the ECG is not connected but the pulse oximeter is, the heart rate will be show in the
same place, in green but the signal will be derived from the pulse oximeter. In this event the
reading will be labelled as shown below. In this condition the systole (heart symbol) is not
shown and the systole tone will not sound. High and low heart rate alarms will operate as
before.
Pulse rate when
measured from
the pulse
oximeter
Pulse Rate Measured from the Pulse Oximeter
Alarm settings
remain as they
were set for the
ECG
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 77
Chapter 6 Taking medical readings
WARNING
You must use the right size of blood pressure cuff to suit the
patient. The cuff’s
6.2 Non-invasive blood pressure (NIBP)
WARNING
WARNING
WARNING
This device should not be used when oscillometric pulses may be altered by other
devices or techniques such as External Counter pulsation (ECP) or Intra-Aortic
Balloon Pump Counter pulsation.
DO NOT use the Blood pressure monitor for any purpose other than specified in this
manual.
DO NOT attach the cuff to a limb being used for IV infusions as the cuff inflation can
block the infusion, potentially causing harm to the patient.
bladder length should be at least 80% of the limb’s circumference which the cuff
width should be equal to 40% of the limb’s circumference. Selecting a cuff that is too
small will result in measurements higher than the patient’s actual blood pressure.
Conversely using too large a cuff will result in too low a reading.
The appropriate cuff sizes are:
Disposable neonate cuff size 1 (3-6 cm),
Disposable neonate cuff size 2 (4-8 cm),
Disposable neonate cuff size 3 (6-11 cm),
Disposable neonate cuff size 4 (7-13 cm),
Disposable neonate cuff size 5 (8-15 cm),
Disposable infant cuff (8-13 cm),
ORANGE infant cuff (8-13 cm),
GREEN child (12-19 cm),
GREEN child LONG (12-19 cm),
ROYAL BLUE small adult (17-25 cm),
ROYAL BLUE small adult LONG (17-25 cm),
NAVY BLUE normal adult (23-33 cm),
NAVY BLUE normal adult LONG (23-33 cm),
BURGUNDY large adult (31-40 cm),
BURGUNDY large adult LONG (31-40 cm),
BROWN adult thigh (38-50 cm).
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 78
WARNING
Always set the Tempus Pro
to
the correct patient
age
to
ensure the initial inflation
Do not apply and pressurize the cuff on any lim
b where intravascular access or
6.2 Non-invasive blood pressure (NIBP)
pressure is set correctly. The Tempus uses the definitions of patient age provided in
IEC80601-2-30 as follows:
Neonate – Children 28 days old or less if born at term (based on 37-week
gestation), otherwise up to 44 gestational weeks.
Paediatric (Child) – Children of 29 days up to and including 12 years old.
Adult – Individuals 13 years old or older.
Failure to set the correct age will result in the Tempus using an inappropriate cuff
inflation pressure which could cause serious harm to a neonate or infant. For
pressures, see “14.1.5 Non-invasive blood pressure”.
Setting the patient age to 2 years or less will mean that inflation pressures, alarm
defaults and alarm ranges will be set to those for a neonate (per IEC80601-2-30).
If you do not set the patient age, the Tempus will use the default patient age group
(see the Tempus Pro Maintenance Manual). Ensure that the patient age/type is
always entered for non-adult patients – see “9.3.5 Entering patient details”.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
The Tempus Pro non-invasive blood pressure monitor is not for use with pregnant,
including pre-eclamptic, patients.
The Tempus Pro may not operate effectively on patients who are experiencing
convulsions or tremors, or who are moving or are in motion (transport) environments.
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.
Do not attempt to take NIBP readings from patients undergoing cardiopulmonary
bypass.
If you suspect a non-invasive blood pressure measurement is invalid, repeat the
measurement. If you remain unsure about the validity of the reading, then take
another measurement using another piece of equipment or a different method.
Do not apply the cuff over a wound, as this can cause further injury.
therapy such as an IV line, saline lock or an arterio-venous (A-V) shunt, is present as
it may cause temporary interference with blood flow and result in injury to the patient.
WARNING
Do not apply and pressurize the cuff on the arm on the side of mastectomy.
WARNING
Application of continuous cuff pressure due to kinking of the blood pressure hose
can interfere with blood flow and result in harmful injury to the patient.
CAUTION
Accuracy of any blood pressure measurement may be affected by the position of the
subject, his or her physical condition and use outside of the operating instructions detailed in
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Chapter 6 Taking medical readings
this manual. Interpretation of blood pressure measurements should be made only by a
physician or trained medical staff.
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Hoses of a certain material and/or durometer may cause the module to perform in an
improper fashion. Only use hoses provided by RDT.
Incorrectly sized cuffs may cause measurement inaccuracy or errors.
If the blood pressure cuff is on the same limb as a pulse oximeter probe, the oxygen
saturation results will be altered when the cuff occludes the brachial artery.
To obtain accurate blood pressure readings, the cuff must be the correct size, and also be
correctly fitted to the patient. Incorrect size or incorrect fitting may result in incorrect
readings.
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.
Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the
formation of urticaria (allergic reaction including raised edematous patches of skin or
mucous membranes and intense itching) caused by the fabric material of the cuff.
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, may lead to Idiopathic thrombocytopenia (spontaneous persistent
decrease in the number of platelets associated with hemorrhagic conditions), or phlebitis
(inflammation of a vein) may be observed.
CAUTION
CAUTION
CAUTION
Note
Note
Note
Blood pressure readings can be affected by patient movement, speech, incorrect sizing and
placement of the cuff and environmental factors (vibration, motion, noise etc.). Care should
be taken to ensure that motion and other artefacts are removed or reduced when taking
blood pressure readings.
Do not place the cuff on the same limb as the pulse oximeter sensor as the cuff may prevent
the pulse oximeter sensor from reading reliably during NIBP measurement cycles.
Ensure the cuff is wrapped firmly around the arm; a loosely applied cuff can result in
artificially high readings.
Compression or restriction of the blood pressure hose or cuff, or induced movement or
vibration or very low pulse volumes may prevent the monitor from taking a reading or may
influence the accuracy of the reading obtained.
The Tempus Pro non-invasive blood pressure monitor is designed to work with the cuffs and
hoses supplied. Use of other cuffs and hoses may compromise performance and accuracy.
The Tempus Pro non-invasive blood pressure monitor does not provide any specific burns
protection parts for non-invasive blood pressure (in accordance with IEC80601-2-30 cl
201.7.9.2.101).
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 80
6.2 Non-invasive blood pressure (NIBP)
6.2.1 Getting started
The Tempus is intended to be used to take non-invasive blood pressure readings from neonates, children,
small adults, adults and large adults. Blood pressure measurements can be affected by the position,
physiologic condition, or activity level of the patient, who should be seated, standing or lying down
depending on the usage model for the device or procedure being performed on the patient. If the patient is
seated, they should have legs uncrossed, feet flat on the floor and back and arms supported. If the patient is
lying (supine) they should not have their legs crossed.
The patient should be comfortable, relaxed as much as possible and not talking during the NIBP
measurement. Before taking the first measurement, a period of at least 5 minutes should elapse to give time
for blood pressure stabilization. When the pressure in the cuff increases, the patient should avoid excess
movement during measurements. Let the cuffed arm hang or lay loosely, slightly away from the body. Avoid
flexing the muscles or moving the hand and fingers of the cuffed arm. Avoid having the cuff or the hose next
to vibrating surfaces.
The patient should be advised to relax as much as possible and not talk during the measurement procedure.
The operator should be positioned in their normal operating position.
To take a non-invasive blood pressure reading, remove the cuff from the rear of the device. If a cuff is not
attached to the hose, or the hose is not attached to the Tempus then make the necessary connections (twist
and lock for the cuff and push/latch to attach the hose).
Ensure the cuff is wrapped firmly around the limb with the cuff placed centrally between the two joints of the
limb i.e. 2-5 cm above the elbow joint or 5-10 cm above the knee. Ensure the end of the cuff wraps around
within the two range lines – if it does not then use a different cuff. Ensure the cuff’s artery marker is placed
over the position of the artery e.g. between the bicep and the tricep for the brachial artery on the arm.
Ensure the hose is not kinked, crushed or damaged.
Remember to place the middle of the cuff at the same level as the right atrium of the heart. Placing the cuff
substantially higher or lower than the heart will result in incorrect readings.
Remember that there may be differences in results between arms and legs, left and right side and can be
affected by the patient’s position (sitting, standing, lying down), exercise or their physiologic condition.
Once the cuff is attached, press the start button shown within the Blood Pressure area. The reading can be
stopped at any time by pressing the button again (it will be labelled STOP).
If an unexpected reading is obtained, wait for a brief period and then take the reading again having checked
the hose for leaks and kinks, the correct placement of the cuff and the patient’s orientation.
Remember that the pressure reading can be affected by common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, arteriosclerosis, poor perfusion, diabetes, age, pregnancy, preeclampsia, renal diseases, patient motion, trembling, shivering etc.
6.2.2 Taking readings
While the cuff is inflating and deflating, the icon in the start button will change to reflect the status of the
reading i.e.:
Cuff is inflating;
Cuff is deflating.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 81
Chapter 6 Taking medical readings
Shows the
Systolic, Mean
and Diastolic
results
Indicates that
Shows the time
the reading was
taken
The Non-Invasive Blood Pressure Section of the Home Screen
Once the measurement has been taken, the icon will change to indicate that the device is on timer as shown
below:
readings will be taken
repetitively at the
interval shown
Press here to start and
stop blood pressure
readings. The graphic
shows the status of the
device
Cuff is on timer;
Cuff is on timer;
Cuff is on timer;
Reading is about to start.
If the device is not set to take readings automatically then it will show the following:
Blood pressure monitor is idle.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 82
6.2 Non-invasive blood pressure (NIBP)
6.2.3 NIBP settings
Pressing anywhere on the non-invasive blood pressure area brings up the NIBP settings menu:
Note
The Tempus Pro Maintenance Manual describes how to set the Tempus to automatically
clear the NIBP reading after 5 minutes if a new reading has not been taken.
Menu option Menu screen
Start – start or stop NIBP readings.
Mode – select Manual, Auto or Rapid Cuff.
Auto interval time (mins) – when in Auto
mode, set the time between NIBP readings.
Systolic limits, Mean limits and Diastolic
limits (mmHg) – set the lower and upper
alarm limits.
Initial inflation (mmHg) – change the initial
inflation pressure. The default value is set by
Tempus depending on patient age group.
Reading format – change the format of
displayed NIBP readings.
NIBP mode
The NIBP can be set to read in three different modes:
Auto – allows the user to set the Tempus to take readings automatically on a cycle (3 mins default, can
be set to 2 mins, 3 mins, 5 mins, 10 mins, 15 mins, 30 mins and 60 mins).
Manual – allows the user to take a single reading only every time the NIBP button is pressed.
Rapid Cuff – where the Tempus will take as many readings as it can in 10 minutes and will then reset
to Auto. If an NIBP technical alarm occurs while in Rapid Cuff mode, the alarm will be reported and the
mode will reset to Auto.
CAUTION
Users should note that Rapid Cuff will only allow a short period between measurements for
arterial recovery. Repeated use of the RapidCuff mode could have physiological effects
including effects on the readings obtained.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 83
Chapter 6 Taking medical readings
Initial inflation
The user can adjust the initial NIBP inflation pressure. The default is set by the Tempus depending on
patient age group – see “9.3.5 Entering patient details”.
NIBP adjusts its inflation pressure dynamically between readings so this setting only applies to the first
reading and when it is manually adjusted.
Patient Type Default initial inflation Range
Adult 160 mmHg 120 to 280 mmHg
Paediatric (29 days to 12 years) 140 mmHg 80 to 280 mmHg
Neonate (<29 days) 90 mmHg 60 to 140 mmHg
NIBP reading format
The Reading format control allows you to choose between two formats for displaying NIBP readings:
NIBP reading format S/D (M)
S = systolic
D = diastolic
M = mean
Note
Regardless of the reading format chosen, the Tempus Pro will continue to monitor the
systolic, mean and diastolic pressures and will still output alarms when thresholds are
exceeded.
NIBP reading format (M) S/D
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 84
6.3 Pulse oximetry
WARNING
Prolonged use or the patient’s condition may require changing the sensor site
Any condition that restricts blood flow, such as use of a blood pressure cuff or
Optical cross
-
talk can occur when two or more sensors are placed in close proximity.
6.3 Pulse oximetry
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Do not use this device in the presence of high EMI/RFI radiation. High EMI/RFI
radiation may cause induced current to the SpO
sensor resulting in patient injury.
2
This device may give inaccurate readings in the presence of strong electromagnetic
sources, such as electrosurgery equipment.
This device may give inaccurate readings in the presence of computed tomography
(CT) equipment.
periodically. Change sensor site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours. Prolonged use may cause blisters, skin
deterioration, and discomfort.
Incorrectly applied sensors may give inaccurate readings.
SpO2 measurements may be inaccurate in the presence of high ambient light. Shield
the sensor area (with a towel, for example) if necessary.
extremes in systemic vascular resistance, may cause an inability to determine
accurate pulse rate and SpO
readings.
2
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Remove fingernail polish or false fingernails before applying SpO2 sensors.
Fingernail polish or false fingernails may cause inaccurate SpO
readings.
2
Significant levels of dysfunctional haemoglobins, such as carboxyhaemoglobin or
methaemoglobin, will affect the accuracy of the SpO
measurement.
2
Tissue damage may result from overexposure to sensor light during photodynamic
therapy with agents such as verteporphin, porfimer sodium and
metatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at least every hour
and observe for signs of tissue damage. More frequent sensor site changes or
inspections may be indicated depending upon the photodynamic agent used, agent
dose, skin condition, total exposure time or other factors. Use multiple sensor sites.
It can be eliminated by covering each site with opaque material. Optical cross-talk
may adversely affect the accuracy of the SpO
readings.
2
Obstructions or dirt on the sensor’s red light or detector may cause a sensor failure
or inaccurate readings. Make sure there are no obstructions and the sensor is clean.
Under certain clinical conditions, pulse oximeters may not display SpO2 and/or pulse
rate values. Under these conditions, pulse oximeters may also display erroneous
values. These conditions include, but are not limited to: patient motion, low
perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above
conditions. Failure of the clinician to recognize the effects of these conditions on
pulse oximeter readings may result in patient injury.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 85
Chapter 6 Taking medical readings
WARNING
Tissue damage can be caused by incorrect application or use of the sensor, for
Reposition
the oximeter probe at least once every hour to allow the patient'
s skin to
The SpO
sensor should snugly fit the finger without straining it and if not alternative
Always read and
follow the instructions on the packaging
of SpO
sensors regarding
WARNING
A pulse oximeter cannot measure elevated levels of COHb or MetHb. Increases in
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Do not use the pulse oximeter for any other purpose than specified in this manual. It
should NOT be used as an apnoea monitor.
Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG based arrhythmia analysis.
A pulse oximeter should be considered an early warning device. As a trend towards
patient deoxygenation is indicated, blood samples should be analysed by a
laboratory co-oximeter to completely understand the patient’s condition.
example by wrapping the sensor too tightly. Inspect the sensor site as directed in the
sensor Directions for Use to ensure skin integrity and correct positioning and
adhesion of the sensor.
Interfering Substances: Carboxyhaemoglobin may erroneously increase readings.
The level of increase is approximately equal to the amount of carboxyhaemoglobin
present.
respire. This time should be reduced in ambient temperatures over 41 C. No other
special actions are required for use in such ambient temperatures although users are
advised to check the sensor site frequently in high temperatures to avoid skin
damage.
fingers should be tried. The probe is sized for patients who weigh 20 kg /44 lbs or
2
more. The probe can be used either on patient’s fingers, thumbs or largest toe.
WARNING
WARNING
WARNING
WARNING
WARNING
The plethysmogram may become unstable on patients who are experiencing
convulsions or tremors, who are moving or are in motion (transport) environments.
2
their storage, use and disposal. In particular take into account any information
regarding toxicity.
For measurements of high or low SpHb readings, blood samples should be analysed
by laboratory instruments to completely understand the patient’s condition.
either COHb or MetHb will affect the accuracy of the SpO2 measurement.
For increased COHb: COHb levels above normal tend to increase the level of SpO2.
The level of increase is approximately equal to the amount of COHb that is present.
For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to
approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in
the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis
(CO-Oximetry) of a blood sample should be performed.
Haemoglobin synthesis disorders may cause erroneous SpHb readings.
Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO, SpHb,
and SpOC measurements.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 86
6.3 Pulse oximetry
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Motion artefact may lead to inaccurate SpMet, SpCO, SpHb, and SpOC
measurements.
Severe anaemia may cause erroneous SpO2 readings.
Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and
SpMet measurements.
With very low perfusion at the monitored site, the readings may read lower than core
arterial oxygen saturation.
Do not use tape to secure the sensor to the site; this can restrict blood flow and
cause inaccurate readings.
Use of additional tape can cause skin damage or damage the sensor.
If the sensor is wrapped to tightly or supplemental tape is used, venous
congestion/pulsations may occur causing erroneous readings.
Venous congestion may cause under reading of actual arterial oxygen saturation.
Therefore, assure proper venous outflow from monitored site. Sensor should not be
below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the
floor).
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Venous pulsations may cause erroneous low readings (e.g. tricuspid valve
regurgitation).
Loss of pulse signal can occur when:
The sensor is too tight.
The patient has hypotension, severe vasoconstriction, severe anaemia, or hypothermia.
There is arterial occlusion proximal to the sensor.
The patient is in cardiac arrest or is in shock.
The pulsations from intra-aortic balloon support can be additive to the pulse rate on
the oximeter pulse rate display.
Verify patient's pulse rate against the ECG heart rate.
Misapplied sensors or sensors that become partially dislodged may cause either over
or under reading of actual arterial oxygen saturation.
Avoid placing the sensor on any extremity with an arterial catheter or blood pressure
cuff.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 87
Chapter 6 Taking medical readings
CAUTION
WARNING
Before use, carefully read the sensor's Directions for Use.
WARNING
To avoid cross contamination only use Masimo single use sensors on the same
patient.
WARNING
Unless otherwise specified, do not sterilize sensors or patient cables by irradiation,
steam, autoclave or ethylene oxide.
WARNING
See the cleaning instructions in the directions for use for the Masimo re-useable
sensors.
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Unplug the sensor from the monitor before cleaning or disinfecting to prevent damaging
sensor or monitor, and to prevent user safety hazards.
Users are reminded that because pulse oximeter measurements are statistically distributed,
only about two-thirds of measurements can be expected to fall within ±Arms of the value
measured by a co-oximeter. Information on the clinical desaturation trials performed to
validate the oximeter is available on request.
Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers
(sensors) may cause improper results.
Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance imaging
(MRI) scanning. Induced current could potentially cause burns. The Pulse CO-Oximeter may
affect the MRI image, and the MRI unit may affect the accuracy of the oximetry
measurements.
Exercise caution when applying a sensor to a site with compromised skin integrity. Applying
tape or pressure to such a site may reduce circulation and/or cause further skin
deterioration.
Circulation distal to the sensor site should be checked routinely.
Note
Note
SpO2 averaging is the number of pulse beats over which the SpO2 value is averaged; pulse
averaging is the number of seconds over which the pulse value is averaged.
DESAT trails were performed in the normal sensitivity mode.
Note
Note
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 88
The plethysmogram is not normalised.
The pulse oximeter probe is for use with intact skin only. The probe used is not sterile and
contains no latex. Patient contact materials have undergone extensive biocompatibility
testing; further information is available on request.
6.3 Pulse oximetry
Note
Note
Note
Note
Note
Note
Note
Note
Any condition that restricts blood flow, such as use of a blood pressure cuff (other than the
Tempus Pro cuff used in accordance with the instructions herein) may cause an inability to
determine accurate pulse and SpO
readings.
2
SpO2 measurements may be adversely affected in the presence of high ambient light levels
(e.g. strong sunlight). This may be more noticeable with disposable probes. If necessary,
shield the sensor area (e.g. with a towel) or a Masimo® light shield.
Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail
polish or false fingernails may cause inaccurate SpO
readings.
2
Performance and safety test data are available on request from RDT, see “RDT contact
details”.
The graphical displays of pulse rate, SpO2 and pulse strength are not proportional to the
pulse volume. The amplitude of the waveform is adjusted on an on-going basis to provide
the largest size waveform possible. Do not attempt to normalise the waveform to any scale.
The SpO
patient must be kept still and either be horizontal to the shoulder (if the patient is lying down)
or below the shoulder (if the patient is sitting upright). If the finger selected does not give
sensor should be on the opposite arm to the blood pressure cuff. The arm of the
2
2
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.
If the accuracy of any measurement does not seem reasonable, first check the patient’s vital
signs by alternate means and the check the MS board pulse oximeter for proper functioning.
NO IMPLIED LICENSE - Possession or purchase of this device does not convey any
express or implied license to use the device with unauthorized sensors or cables that would,
alone or in combination with this device, fall within the scope of one or more of the patents
relating to this device.
Note
Inaccurate measurements may be caused by:
Incorrect sensor application or use
Significant levels of dysfunctional haemoglobins. (e.g., carboxyhaemoglobin or
methaemoglobin)
Intravascular dyes such as indocyanine green or methylene blue.
Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct
sunlight (exposure to excessive illumination can be corrected by covering the sensor
with a dark or opaque material)
Excessive patient movement.
Venous pulsations.
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 89
Chapter 6 Taking medical readings
Note
Note
Loss of pulse signal can occur in any of the following situation:
The sensor is too tight.
There is excessive illumination from light sources such as a surgical lamp, a bilirubin
lamp, or sunlight.
A blood pressure cuff is inflated on the same extremity as the one with a SPO
attached.
The patient has hypotension, severe vasoconstriction, severe anaemia, or hypothermia.
There is arterial occlusion proximal to the sensor.
The patient is in cardiac arrest or is in shock.
High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of
COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be
performed.
sensor
2
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 90
6.3 Pulse oximetry
The following warnings, cautions and notes are reproduced verbatim from Masimo document R-CSD-1117
(revision P):
GENERAL
WARNING
The pulse co-oximeter is to be operated by, or under the supervision of, qualified
personnel only. The manual, accessories, directions for use, all precautionary
information, and specifications should be read before use.
As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.
Do not place the pulse co-oximeter or accessories in any position that might cause it to
fall on the patient.
Do not start or operate the pulse co-oximeter unless the setup was verified to be
correct.
Do not use the pulse co-oximeter during magnetic resonance imaging (MRI) or in an
MRI environment.
Do not use the pulse co-oximeter if it appears or is suspected to be damaged.
Explosion hazard: Do not use the pulse co-oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
To ensure safety, avoid stacking multiple devices or placing anything on the device
during operation.
To protect against injury, follow the directions below:
o Avoid placing the device on surfaces with visible liquid spills.
o Do not soak or immerse the device in liquids.
o Do not attempt to sterilize the device.
o Use cleaning solutions only as instructed in this operator's manual.
o Do not attempt to clean the device while monitoring a patient.
To protect from electric shock, always remove the sensor and completely disconnect
the pulse co-oximeter before bathing the patient.
If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check the pulse co-oximeter for proper functioning
Inaccurate SpCO and SpMet readings can be caused by:
o Improper sensor application
o Intravascular dyes such as indocyanine green or methylene blue
o Abnormal hemoglobin levels
o Low arterial perfusion
o Low arterial oxygen saturation levels including altitude induced hypoxemia
o Elevated total bilirubin levels
o Motion artifact
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 91
Chapter 6 Taking medical readings
WARNING
Inaccurate SpHb and SpOC readings may be caused by:
o Improper sensor application
o Intravascular dyes such as indocyanine green or methylene blue
o Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
o Elevated PaO2 levels
o Elevated levels of bilirubin
o Low arterial perfusion
o Motion artifact
o Low arterial oxygen saturation levels
o Elevated carboxyhemoglobin levels
o Elevated methemoglobin levels
o Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
o Vasospastic disease such as Raynaud's
o Elevated altitude
o Peripheral vascular disease
o Liver disease
o EMI radiation interference
Inaccurate SpO2 readings may be caused by:
o Improper sensor application and placement
o Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with
a seemingly normal SpO2. When elevated levels of COHb or MetHb are
suspected, laboratory analysis (CO-Oximetry) of a blood sample should be
performed.
o Elevated levels of bilirubin
o Elevated levels of dyshemoglobin
o Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
o Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
o Hypocapnic or hypercapnic conditions
o Severe anemia
o Very low arterial perfusion
o Extreme motion artifact
o Abnormal venous pulsation or venous constriction
o Severe vasoconstriction or hypothermia
o Arterial catheters and intra-aortic balloon
o Intravascular dyes, such as indocyanine green or methylene blue
o Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.
o Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal
fingers. etc.
o Skin color disorders
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 92
6.3 Pulse oximetry
WARNING
CAUTION
Interfering Substances: Dyes or any substance containing dyes that change usual
blood pigmentation may cause erroneous readings.
The pulse co-oximeter should not be used as the sole basis for diagnosis or therapy
decisions. It must be used in conjunction with clinical signs and symptoms.
The pulse co-oximeter is not an apnoea monitor.
The pulse co-oximeter may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
The pulse co-oximeter may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
The pulse co-oximeter should not be used for arrhythmia analysis.
SpCO readings may not be provided if there are low arterial saturation levels or
elevated methemoglobin levels.
SpO2, SpCO, SpMet, and SpHb are empirically calibrated in healthy adult volunteers
with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
Do not adjust, repair, open, disassemble, or modify the pulse co-oximeter or
accessories. Injury to personnel or equipment damage could occur. Return the pulse
co-oximeter for servicing if necessary.
Do not place the pulse co-oximeter where the controls can be changed by the patient.
Electrical shock and flammability hazard: Before cleaning, always turn off the device
and disconnect from any power source.
When patients are undergoing photodynamic therapy they may be sensitive to light
sources. Pulse oximetry may be used only under careful clinical supervision for short
time periods to minimize interference with photodynamic therapy.
Do not place the pulse co-oximeter on electrical equipment that may affect the device,
preventing it from working properly.
If SpO2 values indicate hypoxaemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
If the Low Perfusion message is frequently displayed, find a better perfused monitoring
site. In the interim, assess the patient and, if indicated, verify oxygenation status
through other means.
Change the application site or replace the sensor and/or patient cable when a
“Replace sensor” and/or “Replace patient cable”, or a persistent poor signal quality
message (such as “Low SIQ”) is displayed on the host monitor. These messages may
indicate that patient monitoring time is exhausted on the patient cable or sensor.
If using pulse oximetry during full body irradiation, keep the sensor out of the radiation
field. If the sensor is exposed to the radiation, the reading might be inaccurate or the
device might read zero for the duration of the active irradiation period.
The device must be configured to match your local power line frequency to allow for
the cancelation of noise introduced by fluorescent lights and other sources.
To ensure that alarm limits are appropriate for the patient being monitored, check the
limits each time the pulse co-oximeter is used.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 93
Chapter 6 Taking medical readings
CAUTION
Variation in haemoglobin measurements may be profound and may be affected by
sampling technique as well as the patient's physiological conditions. Any results
exhibiting inconsistency with the patient’s clinical status should be repeated and/or
supplemented with additional test data. Blood samples should be analysed by
laboratory devices prior to clinical decision making to completely understand the
patient’s condition.
Do not submerge the pulse co-oximeter in any cleaning solution or attempt to sterilize
by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will
seriously damage the pulse co-oximeter.
Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of
patient-applied circuits and the system are within acceptable limits as specified by the
applicable safety standards. The summation of leakage currents must be checked and
in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be
checked when connecting external equipment to the system. When an event such as a
component drop of approximately 1 meter or greater or a spillage of blood or other
liquids occurs, retest before further use. Injury to personnel could occur.
Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse co-oximeter.
Replace the cable or sensor when a replace sensor or when a low SIQ message is
consistently displayed while monitoring consecutive patients after completing
troubleshooting steps listed in this manual.
Note
A functional tester cannot be used to assess the accuracy of the pulse co-oximeter.
High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the pulse co-oximeter to obtain vital sign readings.
When using the Maximum Sensitivity setting, performance of the "Sensor Off"
detection may be compromised. If the device is in this setting and the sensor becomes
dislodged from the patient, the potential for false readings may occur due to
environmental "noise" such as light, vibration, and excessive air movement.
Do not loop the patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
Additional information specific to the Masimo sensors compatible with the pulse
oximeter, including information about parameter/measurement performance during
motion and low perfusion, may be found in the sensor's directions for use (DFU).
Cables and sensors are provided with X-Cal™ technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or
Sensor DFU for the specified duration of the patient monitoring time.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 94
6.3 Pulse oximetry
6.3.1 Getting started
To use the pulse oximeter, remove the soft finger probe from the back of the device. Attach it to a wellperfused finger of the patient taking care to ensure it is not the same arm which has a blood pressure cuff
attached. The readings will begin a few seconds after the probe is attached to the patient.
The
plethysmogram is
shown
continuously
reading is
provided shown
here
The signal
strength and
The SpO2
The Pulse Oximetry Section of the Home Screen
perfusion index
of the site are
shown here
The SpO2 section gives the oxygen saturation of the blood and shows the plethysmogram, signal strength
(in bar graph form) and the perfusion index.
The Signal Quality bar graph shows how well the pulse sensor is detecting the pulse. The amplitude of the
indication indicates the quality of detection. If the indication on the Signal Strength meter is low, or becomes
low, then the finger sensor should be repositioned. Similarly, the Perfusion Index gives a numerical
indication of the level of arterial pulsatile blood at the sensor site.
The Pulse Rate displayed on the Tempus Pulse Oximeter may differ slightly from the heart rate displayed on
ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac
electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the
signal quality due to physiological changes in the patient or one of the instruments or application of the
sensor or patient cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed
on the Tempus to be significantly different than the ECG heart rate.
The perfusion index (PI) indicator provides a relative numeric indication of the pulse strength at the
monitoring site. It is a calculated percentage between the pulsatile signal and non-pulsatile signal of arterial
blood moving through the site. PI may be used to find the best perfused site and to monitor physiological
changes in the patient. It displays an operating range of 0.02 % to 20.00 %. A percentage greater than 1.00
% is desired. Extreme changes in the display number are due to motion artefact and changes in physiology
and blood flow.
The device indicates perfusion on a 7-bar LED indicator. The lower two segments of the bar will turn red
when the amplitude of the arterial pulsations is very low (low perfusion). It has been suggested that at
extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from
central arterial saturation. This “localized hypoxemia” may result from the metabolic demands of other
tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral
hypoperfusion. (This may occur even with a pulse rate that correlates with the ECG heart rate.)
CAUTION
If the low perfusion indication is frequently displayed, find a better-perfused monitoring site.
In the interim assess the patient and if indicated verify oxygenation status through other
means.
6.3.2 Pleth variability index
Pleth Variability Index or PVI® helps users to discern between patients who may respond to fluid from those
who may not.
PVI has been shown to help clinician to predict fluid responsiveness in mechanically ventilated patients
under general anaesthesia, defined as a significant increase in cardiac output after fluid administration. PVI
is an automatic measure of the dynamic change in Perfusion Index (PI) that occurs during the respiratory
cycle.
PVI = ((PI
The greater the PVI, the more likely the patient will respond to fluid administration. Typically, a PVI of >14%
prior to volume expansion is predictive that a mechanically ventilated patient will respond to fluid
max
-PI
min
)/PI
) x 100.
max
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 95
Chapter 6 Taking medical readings
administration (81% sensitivity). A PVI prior to volume expansion is predictive that a mechanically ventilated
patient will not respond to fluid administration (100% specificity).
®
PVI
is an option for Tempus Pro.
The PVI value is
shown here
The Pulse Oximetry Section with PVI
6.3.3 Taking readings
Note
Depending on which of the features have been purchased, some of the features shown
below may not be available on your Tempus Pro device.
1. Remove the patient cable from the RapidPak area of the Tempus.
2. Connect the SpO
cable to the Tempus Pro.
2
3. Attach the chosen sensor to the patient cable:
SpO2 sensor - SpO2, PI and PVI
SpCO sensor - SpCO, SpMet, Sp02, PI and PVI
SpHb sensor - SpHb, SpMet, SpOC, Sp02, PI and PVI
Attach it to a well-perfused finger of the patient taking care to ensure it is not the same arm which has a
blood pressure cuff attached. The measurement will begin as soon as the probe is attached to the patient
but different values take different lengths of time to appear on the screen.
Standard Waveform view
Large Waveform view
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 96
6.3.4 Features
6.3 Pulse oximetry
The
plethysmogram and
signal strength are
The SpO2
reading is
shown here
shown continuously
Masimo Rainbow parameters are
displayed here
The SpCO index, Perfusion index
and Pleth Variability Index of the
site are shown here
The Pulse Oximetry section of the home screen
Depending on which features have been purchased for your Masimo Rainbow Pulse OX and which sensor
you are using will depend on which of the following features the Tempus Pro can monitor.
Masimo
SpO
®
SET® measurements supplied as standard:
- Intended for non-invasive measurement of arterial blood saturation and also provides pulse rate
2
when ECG is not attached.
Pulse Rate (PR).
Perfusion Index (PI) - Gives a numerical indication of the level of arterial pulsatile blood at the sensor
site.
Masimo
®
SET® Rainbow measurements purchased as optional upgrades:
SpCO - Allows clinicians to noninvasively and immediately detect elevated levels of carbon monoxide.
SpMet - Allows clinicians to noninvasively and immediately detect elevated levels of methaemoglobin in
the blood.
SpHb Index - Gives continuous monitoring of the haemoglobin levels in blood.
SpOC - Gives the patient’s oxygenation status by calculating the haemoglobin and oxygen saturation.
PVI purchased as an optional upgrade:
Pleth Variability Index (PVI) - Helps clinicians noninvasively and continuously assess fluid status of
patients.
The Signal Quality waveform (underneath the plethysmogram) shows how well the pulse sensor is detecting
the pulse. The height of the peak indicates the strength of the signal, if the peaks are short the finger sensor
should be repositioned.
The Pulse Rate displayed on the Tempus Pulse Oximeter may differ slightly from the heart rate displayed on
ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac
electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the
signal quality due to physiological changes in the patient or one of the instruments or application of the
sensor or patient cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed
on the Tempus to be significantly different than the ECG heart rate.
The device indicates perfusion. It has been suggested that at extremely low perfusion levels, pulse
oximeters can measure peripheral saturation, which may differ from central arterial saturation. This
“localized hypoxemia” may result from the metabolic demands of other tissues extracting oxygen proximal to
the monitoring site under conditions of sustained peripheral hypoperfusion. (This may occur even with a
pulse rate that correlates with the ECG heart rate).
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 97
Chapter 6 Taking medical readings
CAUTION
If the low perfusion indication is frequently displayed, find a better-perfused monitoring site.
In the interim assess the patient and if indicated verify oxygenation status through other
means.
6.3.5 Pulse oximetry probes
The following pulse oximetry sensors may be used with the Tempus Pro: standard, SpCO or SpHb. Each
sensor shows a different range of parameters. There is no single sensor that shows all parameters.
The standard adult SpO2 reusable sensor reads SpO2, PI and PVI
The Standard adult SpO2 section
The SpCO sensor reads SpCO, SpMet, SpO2, PI and PVI
The Pulse Oximetry section with SpCO
The SpHb sensor reads SbHb, SpMet, SpOC, SpO2, PI and PVI
The Pulse Oximetry section with SpHb
Note
Depending on which sensor is used the Tempus will display only the available parameters.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 98
6.3 Pulse oximetry
6.3.6 Pulse oximeter settings
Pressing anywhere in the plethysmogram area brings up the Pulse Oximeter Settings menu:
The SpCO, SpMet, SpHb and SpOC limits are only activated when their Masimo licenses have been
installed and the appropriate probes are plugged in.
Note
PI and PVI alarms are only available in Tempus Pro devices with part numbers ending in
"-R".
Menu option Menu screen
SpO2, SpCO and SpMet limits (%) – set the
upper and lower alarm limits for SpO2, SpCO
and SpMet.
SpHb limits and settings – open the SpHb
Settings menu, see “6.3.7 SpHb settings”.
HR/PR source – select ECG or Pulse
oximeter as the heart/pulse rate source.
Large pleth waveform – turn the large pleth
waveform display on and off.
Sensitivity mode – adjust sensitivity by
pressing Max, Norm or APOD.
Averaging time (s) – use the up and down
arrows to adjust averaging time in seconds.
FastSAT – turn FastSAT on or off.
Cardiac wave speed (mm/s) – change wave
speed. This setting is common to ECG, Sp02
and IP.
HR/PR beat volume - volume of the audible
tone that the Tempus emits every time a
heartbeat is detected.
SpOC limits (ml/dl) – set the upper and lower
alarm limits for SpOC.
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 99
Chapter 6 Taking medical readings
Menu option Menu screen
PI limits (%) – set the upper and lower alarm
limits for Perfusion Index.
PVI limits (%) – set the upper and lower
alarm limits for Pleth Variability Index.
Pulse tones
Pulse tones can be turned on from either the Pulse Oximeter Settings menu or the ECG Settings menu
using the settings:
HR/PR source = pulse
HR/PR beat volume = 20% (or above)
When pulse tones are turned on Tempus Pro emits a beep for each pulse beat detected. The beep tone
(frequency) depends on the value of pulse ox saturation (SpO2). Higher SpO2 values mean that each beat
is emitted with a higher tone beep and vice-versa. So the tone drops as SpO2 (%) falls, with the lowest
frequency tone at values of SpO2 = 80% or below.
Note
Note
Alarm tones have priority over pulse tones. When pulse tones are enabled, user interface
touch screen sounds are suppressed.
Pulse tones are automatically enabled if the laryngoscope is used.
Averaging time
The pulse oximeter can be set to average its heart rate reading over different time periods. By default, this
is 8 seconds. This can be adjusted to make the reading more or less responsive. The available settings
are: (2-4 seconds, 4-6 seconds, 8 seconds, 10 seconds, 12 seconds, 14 seconds and 16 seconds).
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 100
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