Dräger Infinity Acute Care System M540 User manual

Instructions for Use
Infinity Acute Care System
M540 Patient Monitor
Software VG2
WARNING
To properly use this medical device,
read and comply with these Instruc-
tions for Use.

2Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
Typographical conventions
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for exam-
ple, Alarms, or Menu.
The "greater than" symbol >indicates the naviga-
tion path in a dialog window, for example, Menu >
Patient setup > Admit date. In this example,
Menu represents the fixed key, Patient setup rep-
resents a horizontal tab, and Admit date a menu
selection.
Screen images
Schematic renderings of screen images are used,
which may differ in appearance or in configuration
from the actual screen images.
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
zBullet points indicate individual actions or differ-
ent options for action.
– Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
related illustration.
ALetters in illustrations denote elements referred
to in the text.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 3
Trademarks and patents
– Acute Care SystemTM
– DrägerService®
– Infinity®
– Hemo4®
– Hemo2®
– Innovian®
–MCable
®
– Medical CockpitTM
–MPod
®
– MonoLead®
–TruST
®
are trademarks of Dräger.
–Masimo
®
– Masimo SET®(Signal Extraction Technology)
– Masimo Rainbow®SET
– PVI®
–SpCO
®
–SpHb
TM
–SpMet
®
–SpOC
TM
are registered trademarks of the Masimo corpora-
tion.
– DurasensorTM
– Nellcor®
– OxiMax®
– OxiCliqTM
–OxiBand
TM
–SoftCare
TM
– SatSeconds®
are trademarks of Nellcor Puritan Bennett, LLC.
– ComplianceTM
is a trademark of Cardinal Health, Inc.
– Dismozun®pur
is a trademark of BODE Chemie GmbH.
– Sporox II®
is a trademark of Sultan Healthcare, Inc.

4Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
Safety information definitions
Abbreviations and symbols
Please refer to "Device symbols" on page 26 and to
"Abbreviations" on page 28 for explanations.
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important infor-
mation about a potentially hazardous situation
which, if not avoided, may result in minor or mod-
erate injury to the user or patient or in damage to
the medical device or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 5
Contents
Contents
For your safety and that of your patients. . . 9
General safety information . . . . . . . . . . . . . . . . 13
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Infinity M540 . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
System overview . . . . . . . . . . . . . . . . . . . . . . 19
Overview of Infinity M540 . . . . . . . . . . . . . . . . . 20
Infinity M500 docking station . . . . . . . . . . . . . . 23
Additional hardware . . . . . . . . . . . . . . . . . . . . . 24
Device symbols . . . . . . . . . . . . . . . . . . . . . . . . 26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Operating concept . . . . . . . . . . . . . . . . . . . . . 31
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
M540 wireless mode . . . . . . . . . . . . . . . . . . . . 32
Function keys . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Monitoring area. . . . . . . . . . . . . . . . . . . . . . . . . 38
Adjusting the display. . . . . . . . . . . . . . . . . . . . . 41
Battery power . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Power-saving mode . . . . . . . . . . . . . . . . . . . . . 43
Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Standby mode. . . . . . . . . . . . . . . . . . . . . . . . . . 45
Privacy mode . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Docking/undocking the M540 . . . . . . . . . . . . . . 49
Locking/unlocking the M540. . . . . . . . . . . . . . . 50
Connecting the system cables in an IACS
configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Connecting the system cable in an M540
stand-alone configuration . . . . . . . . . . . . . . . . . 51
Mounting the Infinity MCable – Masimo SET
and Masimo Rainbow SET/Nellcor OxiMax
MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 55
Overview of monitoring a patient . . . . . . . . . . . 56
Turning the M540 on/off . . . . . . . . . . . . . . . . . . 56
Admitting a patient . . . . . . . . . . . . . . . . . . . . . . 57
Discharging a patient . . . . . . . . . . . . . . . . . . . . 58
Patient categories . . . . . . . . . . . . . . . . . . . . . . 58
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Overview of alarms . . . . . . . . . . . . . . . . . . . . . 62
Alarm priorities . . . . . . . . . . . . . . . . . . . . . . . . 62
Alarm processing. . . . . . . . . . . . . . . . . . . . . . . 63
Activating or deactivating alarm validation . . . 64
Visual alarm signals . . . . . . . . . . . . . . . . . . . . 65
Acoustic alarm signals. . . . . . . . . . . . . . . . . . . 67
Testing visual and acoustic alarm signals . . . . 68
Special alarm behavior . . . . . . . . . . . . . . . . . . 68
Pre-silencing alarms . . . . . . . . . . . . . . . . . . . . 70
Pausing acoustic alarm signals . . . . . . . . . . . . 70
Pausing alarm monitoring temporarily . . . . . . . 71
Activating or deactivating alarm monitoring. . . 72
Configuring a patient’s alarm settings . . . . . . . 73
Event recall . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Viewing a snapshot of a single event . . . . . . . 77
Alarm management setup (password-
protected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
The Code function key . . . . . . . . . . . . . . . . . . 78
Alarm groups . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Alarm ranges and defaults . . . . . . . . . . . . . . . 79
ECG, arrhythmia, and ST segment. . . . . . . . 87
Overview of ECG and heart rate monitoring . . 89
ECG precautions . . . . . . . . . . . . . . . . . . . . . . . 90
Connecting the 3-, 5-, 6-lead wire sets for
ECG monitoring. . . . . . . . . . . . . . . . . . . . . . . . 90
Connecting the lead wire set for 12-lead ECG
monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Connecting the lead wires for neonatal ECG
monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Patient preparation for ECG monitoring . . . . . 93
ECG display . . . . . . . . . . . . . . . . . . . . . . . . . . 94
ECG electrode colors . . . . . . . . . . . . . . . . . . . 95
Electrode placement . . . . . . . . . . . . . . . . . . . . 95
12-lead monitoring. . . . . . . . . . . . . . . . . . . . . . 98
Accessing the ECG dialog window . . . . . . . . . 99
ECG parameter setup functions . . . . . . . . . . . 99
Monitoring paced patients . . . . . . . . . . . . . . . . 102
Pacemaker precautions. . . . . . . . . . . . . . . . . . 103
Optimizing pacer processing . . . . . . . . . . . . . . 105
Arrhythmia monitoring overview . . . . . . . . . . . 105

Contents
6Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
Selecting ARR leads . . . . . . . . . . . . . . . . . . . . 106
ARR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
ARR display . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Accessing the ARR dialog window . . . . . . . . . . 110
ARR parameter setup functions . . . . . . . . . . . . 110
Monitoring ST overview . . . . . . . . . . . . . . . . . . 111
Standard ST monitoring . . . . . . . . . . . . . . . . . . 111
TruST 12-lead monitoring. . . . . . . . . . . . . . . . . 112
12-Lead ST monitoring. . . . . . . . . . . . . . . . . . . 112
Connecting lead wire sets for ST monitoring . . 113
ST display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
ST complex dialog windows . . . . . . . . . . . . . . . 114
ST measuring points . . . . . . . . . . . . . . . . . . . . 115
ST reference. . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Accessing the ST dialog window . . . . . . . . . . . 116
ST setup functions . . . . . . . . . . . . . . . . . . . . . . 116
Learning/relearning QRS pattern . . . . . . . . . . . 118
Impedance respiration (RRi) . . . . . . . . . . . . . 119
Overview of RRi monitoring . . . . . . . . . . . . . . . 120
RRi precautions . . . . . . . . . . . . . . . . . . . . . . . . 120
Connecting the 3-, 5-, 6-lead wire sets for RRi
monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Connecting the lead wire set for 12-lead RRi
monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Connecting the lead wires for neonatal RRi
monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Patient preparation for respiration monitoring . 123
RRi display . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
RRi measuring modes . . . . . . . . . . . . . . . . . . . 126
Accessing the RRi dialog window . . . . . . . . . . 126
RRi parameter setup functions . . . . . . . . . . . . . 127
SpO2and Pulse CO-Ox monitoring with
Masimo SET MCables . . . . . . . . . . . . . . . . . . 129
Overview of SpO2monitoring . . . . . . . . . . . . . . 130
SpO2and Pulse CO-Ox precautions . . . . . . . . 132
Connecting the Masimo SET MCable . . . . . . . 134
Connecting the Masimo Rainbow SET
MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Patient preparation . . . . . . . . . . . . . . . . . . . . . . 136
SpO2and Pulse CO-Ox display . . . . . . . . . . . . 137
Accessing the SpO2dialog window . . . . . . . . . 139
SpO2parameter setup functions . . . . . . . . . . . 139
Accessing the Pulse CO-Ox dialog window . . . 141
Pulse CO-Ox parameter setup functions . . . . . 141
Password-protected Masimo Rainbow SET
setup functions . . . . . . . . . . . . . . . . . . . . . . . . . 144
SpO2and pulse rate with Nellcor OxiMax
MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Overview of SpO2monitoring . . . . . . . . . . . . . 146
SpO2precautions . . . . . . . . . . . . . . . . . . . . . . 147
Connecting the Nellcor OxiMax MCable . . . . . 148
Patient preparation for SpO2monitoring . . . . . 149
SpO2display . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Accessing the SpO2dialog window. . . . . . . . . 151
SpO2parameter setup functions . . . . . . . . . . . 151
Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . 153
Overview of temperature monitoring . . . . . . . . 154
Connecting the temperature sensors . . . . . . . 154
Temperature display . . . . . . . . . . . . . . . . . . . . 157
Accessing the temperature dialog window . . . 158
Temperature parameter setup functions . . . . . 158
Non-invasive blood pressure (NIBP) . . . . . . 159
Overview of NIBP monitoring . . . . . . . . . . . . . 160
NIBP precautions . . . . . . . . . . . . . . . . . . . . . . 161
Connecting the NIBP hose and cuff . . . . . . . . 162
Patient preparation for NIBP monitoring . . . . . 163
NIBP display . . . . . . . . . . . . . . . . . . . . . . . . . . 164
NIBP measurement modes . . . . . . . . . . . . . . . 165
Venous stasis . . . . . . . . . . . . . . . . . . . . . . . . . 167
Accessing the NIBP dialog window . . . . . . . . . 168
NIBP parameter setup functions . . . . . . . . . . . 168
Invasive blood pressure (IBP) . . . . . . . . . . . 169
Overview of IBP monitoring. . . . . . . . . . . . . . . 170
IBP precautions. . . . . . . . . . . . . . . . . . . . . . . . 172
Connecting the Hemo4 and Hemo2 pods . . . . 173
Connecting the MPod – QuadHemo . . . . . . . . 174
Connecting the Dual Hemo MCable . . . . . . . . 175
Patient preparation for IBP monitoring . . . . . . 176
IBP display . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Labeling IBP pressure channels . . . . . . . . . . . 177
Standard pressure labels. . . . . . . . . . . . . . . . . 178
Pressure label conflicts . . . . . . . . . . . . . . . . . . 179
Zeroing an IBP transducer . . . . . . . . . . . . . . . 179
Pulmonary wedge pressure. . . . . . . . . . . . . . . 181
Accessing the IBP dialog window . . . . . . . . . . 181
IBP parameter setup functions . . . . . . . . . . . . 181
Cardiac Output (C.O.) . . . . . . . . . . . . . . . . . . 183
Overview of Cardiac Output (C.O.)
monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 7
Contents
C.O. precautions. . . . . . . . . . . . . . . . . . . . . . . . 184
Connecting the C.O. hardware. . . . . . . . . . . . . 185
Patient preparation for C.O. monitoring . . . . . . 187
Carbon Dioxide Concentrations (CO2). . . . . 189
Overview of CO2monitoring. . . . . . . . . . . . . . . 190
CO2precautions. . . . . . . . . . . . . . . . . . . . . . . . 190
Connecting the CO2sensor . . . . . . . . . . . . . . . 192
Patient preparation for CO2monitoring . . . . . . 193
CO2display . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Accessing the CO2dialog window . . . . . . . . . . 196
CO2parameter setup functions . . . . . . . . . . . . 196
System configuration. . . . . . . . . . . . . . . . . . . 199
System configuration overview. . . . . . . . . . . . . 200
Configuring general settings. . . . . . . . . . . . . . . 201
Configuring the patient settings . . . . . . . . . . . . 202
Configuring the system settings . . . . . . . . . . . . 203
Viewing the system information . . . . . . . . . . . . 205
Configuring the biomed settings . . . . . . . . . . . . 206
Configuring the screen setup . . . . . . . . . . . . . . 208
Configuring alarm settings . . . . . . . . . . . . . . . . 210
Problem solving. . . . . . . . . . . . . . . . . . . . . . . 211
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Device communication messages . . . . . . . . . . 212
M540 battery messages . . . . . . . . . . . . . . . . . . 213
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
ST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
ARR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Respiration (RRi) . . . . . . . . . . . . . . . . . . . . . . . 218
SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
IBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
CO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Maintenance of the IACS components . . . . . . . 237
Safety inspections . . . . . . . . . . . . . . . . . . . . . . 238
Cleaning and disinfection . . . . . . . . . . . . . . . 239
Overview of cleaning and disinfecting the
M540 and its accessories . . . . . . . . . . . . . . . . . 240
Approved cleaning agents . . . . . . . . . . . . . . . . 241
Cleaning and disinfecting the M540, M500,
and PS50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Cleaning and disinfecting MCables and
MPods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Cleaning and disinfecting patient cables . . . . . 244
Cleaning and disinfecting reusable ECG lead
wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Cleaning and disinfecting temperature
sensors and cables . . . . . . . . . . . . . . . . . . . . . 245
Cleaning NIBP cuffs . . . . . . . . . . . . . . . . . . . . 246
Cleaning and disinfecting IBP transducers
and hemodynamic pods . . . . . . . . . . . . . . . . . 246
Cleaning and disinfecting mainstream CO2
sensors and airway adapters . . . . . . . . . . . . . 247
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Technical data . . . . . . . . . . . . . . . . . . . . . . . . 251
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Infinity M540 . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Infinity M500 . . . . . . . . . . . . . . . . . . . . . . . . . . 255
Power supply (PS50). . . . . . . . . . . . . . . . . . . . 256
Infinity MCable – Mainstream CO2. . . . . . . . . 257
Infinity MCable – Masimo SET and Infinity
MCable – Masimo SET Rainbow . . . . . . . . . . 258
Infinity MCable – Nellcor OxiMax . . . . . . . . . . 259
Infinity Hemo2 and Hemo4 pods . . . . . . . . . . . 260
Infinity MPod – Quad Hemo . . . . . . . . . . . . . . 261
Infinity MCable – Dual Hemo. . . . . . . . . . . . . . 262
Analog Sync MCable. . . . . . . . . . . . . . . . . . . . 263
Infinity MCable – Nurse Call . . . . . . . . . . . . . . 265
Parameter monitoring specifications . . . . . . . . 266
Electromagnetic compatibility . . . . . . . . . . . . . 281

8Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
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Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 9
For your safety and that of your patients
For your safety and that of your patients
Strictly follow these Instructions for Use. . . . . . 10
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Safety inspections and maintenance . . . . . . . . 10
Safety inspections . . . . . . . . . . . . . . . . . . . . . . 10
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Installing accessories . . . . . . . . . . . . . . . . . . . . 11
Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 11
Restrictions for use. . . . . . . . . . . . . . . . . . . . . . 11
Connected devices. . . . . . . . . . . . . . . . . . . . . . 11
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Networking and connection to other devices . . 11
Connection to hospital network . . . . . . . . . . . . 12
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 12
General safety information . . . . . . . . . . . . . . 13
Not for use in areas of explosion hazard or in
oxygen-enriched areas . . . . . . . . . . . . . . . . . . . 13
Information on electromagnetic compatibility . . 14
Site of operation . . . . . . . . . . . . . . . . . . . . . . . . 14
Defibrillator precautions . . . . . . . . . . . . . . . . . . 14
Electrosurgery . . . . . . . . . . . . . . . . . . . . . . . . . 15

10 Instructions for Use Infinity Acute Care System – M540 Patient MonitorSW VG2
For your safety and that of your patients
Strictly follow these Instructions for Use
Training
Training for users is available from the responsible
Dräger organization. See www.draeger.com for
more information.
Safety inspections and maintenance
Safety inspections
The medical device must be subject to regular
safety inspections. See the chapter "Maintenance".
WARNING
Any use of the medical device requires full
understanding and strict observation of all
sections of these Instructions for Use. The
medical device must only be used for the pur-
pose specified under "Intended use"
on page 17 and in conjunction with appropri-
ate patient monitoring. Strictly observe all
WARNING and CAUTION statements through-
out these Instructions for Use and all state-
ments on medical device labels. Failure to
observe these safety information statements
constitutes a use of the medical device that is
inconsistent with its intended use.
WARNING
Every medical device must be inspected regu-
larly to ensure it remains safe to use.
This medical device must be inspected and
serviced regularly by trained technical per-
sonnel. Trained technical personnel should
also perform any repairs that are necessary.
Only authentic Dräger repair parts should be
used for maintenance. Using non-Dräger
repair parts may adversely affect the opera-
tion of the device (see the "Maintenance"
chapter). Dräger also recommends obtaining
a service contract so that all repairs are per-
formed by DrägerService.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 11
For your safety and that of your patients
Accessories
Installing accessories
Strictly observe Assembly instructions and Instruc-
tions for Use.
Sterile accessories
Restrictions for use
Connected devices
Safe connection with other electrical
equipment
Networking and connection to other
devices
When combining Dräger devices with other electri-
cal devices, the owner must ensure that the result-
ing system meets the requirements of the following
standards:
– IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compati-
bility; Requirements and tests
WARNING
Only the accessories indicated in the Infinity
Acute Care System – M540 Patient Monitor
Instructions for Use (latest edition) have been
tested and approved for use with the medical
device.
Therefore, it is strongly recommended that
only these accessories are used in conjunc-
tion with the medical device. Otherwise, the
correct functioning of the medical device may
be compromised.
CAUTION
Install accessories to the basic device in accor-
dance with the Instructions for Use of the basic
device. Make sure that there is a safe connection
to the basic device system.
CAUTION
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged or there
are other signs of non-sterility. Disposable articles
must not be reprocessed and resterilized. Reuse,
reprocessing, or resterilization can lead to a fail-
ure of the medical device and cause injury to the
patient.
CAUTION
Device for use in clinical settings only and exclu-
sively by persons with specific training and expe-
rience in its use.
WARNING
Connecting devices or combinations of
devices in ways not described within these
Instructions for Use may adversely affect the
operation of any or all of the connected medi-
cal devices and may put the patient at risk of
receiving an electric shock. Before operating
any combination of devices, strictly comply
with the Instructions for Use for all connected
devices.
CAUTION
Electrical connections to equipment not listed in
these Instructions for Use or Assembly Instruc-
tions must only be made when approved by each
respective manufacturer.

For your safety and that of your patients
12 Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
– IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Combinations of Dräger devices and third-party
devices that are not approved by Dräger may
adversely affect operation of those devices and
may put the patient at greater risk of injury.
Strictly follow the Assembly Instructions and
Instructions for Use for each connected device.
Connection to hospital network
Many medical devices manufactured by Dräger use
networks to transmit patient data in real-time and to
notify clinical users of alarm conditions. Hospitals
should refer to IEC 80000-1 before attempting to
connect such medical devices to their IT networks.
The technical documentation that IEC 80000-1
requires manufacturers such as Dräger to make
available in support of such network connections
can be requested. Contact your Dräger representa-
tive for that information or to facilitate negotiation of
an IEC 80000-1 Responsibility Agreement for addi-
tional support from Dräger.
Patient safety
The design of the medical device, the accompany-
ing documentation, and the labeling on the medical
device are based on the assumption that the pur-
chase and the use of the medical device are
restricted to medical professionals, and that certain
inherent characteristics of the medical device are
known to a clinical user. Instructions and WARN-
ING and CAUTION statements are therefore
largely limited to the specifics of the Dräger medical
device.
These Instructions for Use do not refer to various
hazards which are obvious to a medical profes-
sional who operates this medical device as well as
references to the consequences of medical device
misuse, and to potentially adverse effects in
patients with different underlying diseases. Modify-
ing or misusing this medical device can be danger-
ous.
CAUTION
The medical device must only be used with soft-
ware tested and approved by Dräger. Any modifi-
cations of the operating system settings can
impair operating safety. Responsibility for any
such modifications lies with the owner.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 13
For your safety and that of your patients
General safety information
The following WARNING and CAUTION state-
ments apply to general operation of the medical
device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
Instructions for Use or in the Instructions for Use of
another product being used with this device.
Restriction of Distribution
Federal Law (U.S.) restricts this device to sale by or
on the order of a physician.
Not for use in areas of explosion hazard
or in oxygen-enriched areas
WARNING
Follow local regulations for safe disposal of
batteries. To prevent fire or explosion, never
dispose of batteries in fire.
WARNING
To avoid electric shock, inspect all cables
before use. Never use cables that appear
cracked, worn, or damaged in any way (doing
so may compromise performance or put the
patient at risk).
CAUTION
To avoid injuring the patient, disconnect all sen-
sors that will not be used during transport, before
moving the patient.
CAUTION
Read all cleaning instructions (for example, origi-
nating from the disinfectant manufacturer and the
hospital) carefully before cleaning the device.
Refer to the chapter entitled "Cleaning and disin-
fection" on page 239 for device-specific cleaning
instructions. Moisture may damage the circuits,
compromise critical performance and present a
safety risk.
WARNING
This medical device is not for use in oxygen-
enriched areas or in areas where combustible
explosive gas mixtures are likely to occur.
WARNING
When placing the device, make sure adequate
airflow exists. Do not cover the device with
blankets.

For your safety and that of your patients
14 Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
Information on electromagnetic
compatibility
Medical electrical equipment is subject to special
precautionary measures concerning electromag-
netic compatibility (EMC) and must be installed and
put into operation in accordance with the EMC
information provided on page 279.
The performance of the medical electrical equip-
ment may be affected by using portable or mobile
RF communications equipment near it.
Site of operation
Only use devices (monitors, MPods, MCables, and
accessories) in areas that meet the environmental
requirements outlined in the technical data section.
Defibrillator precautions
The M540 and the peripheral devices are protected
against high-frequency interference from defibrilla-
tors and electrosurgical units and against 50- and
60-Hz power line interference.
WARNING
Do not touch the patient while
touching other conductive parts,
including exposed pins or a con-
nector marked with the ESD warn-
ing symbol.
WARNING
To avoid interfering with device operation, do
not operate devices (monitors, MPods, MCa-
bles, and accessories) within 10 m (33 feet) of
equipment that emits microwave or other
high-frequency emissions.
WARNING
Make sure that the device is properly mounted
and secured to prevent injury. Make sure the
requirements for maximum load and slope of
floor are met. Consult the documentation of
the mounting manufacturer for detailed
information.
WARNING
To minimize the risk of patient strangulation,
carefully position and secure sensor cables.
Also position the sensor cables to minimize
inductive loops.
CAUTION
To prevent overheating, do not place the device in
direct sunlight or near radiant heaters.
CAUTION
After extended exposure in a cold environment,
acclimate the device carefully so that condensa-
tion does not form on the electronic parts and
damage the device.
CAUTION
To avoid damaging the touch-sensitive screen, do
not allow sharp instruments to touch the front
panel of the devices.
CAUTION
To avoid short-circuiting and otherwise damaging
the device, Dräger recommends that no fluids
come in contact with the IACS devices when they
are connected to a power socket. If fluids are acci-
dentally spilled on the equipment, remove the
affected device from service as soon as possible
and have technical personnel verify that patient
safety is not compromised.
CAUTION
To prevent burns and electric shock due to rerout-
ing of electrical current through electrodes, do not
position the defibrillator pads near any electrodes
or sensors.
CAUTION
Only defibrillate across the chest.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 15
For your safety and that of your patients
Electrosurgery
Observe the following precautions during electro-
surgery to reduce electrosurgical unit (ESU) inter-
ference and improve operator and patient safety.
CAUTION
Using ECG electrodes and cables specified by
Dräger protects the device from damage during
defibrillation and reduces noise and other interfer-
ence on the ECG waveform.
WARNING
For better performance and to reduce the haz-
ard of burns during surgery, always use
accessories designed for ESU environments.
Do not use skin temperature sensors.
WARNING
To reduce the hazard of burns during electro-
surgery, keep the sensor or transducer (ECG,
pressure, SpO2) and their associated cables
away from the surgical site, the ESU return
electrode, and earth ground.
NOTE
Cover internally placed reusable temperature sen-
sors with temperature probe sheaths.

16 Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
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Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 17
Intended use
Intended use
Infinity M540 . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Indications for use . . . . . . . . . . . . . . . . . . . . . . 18

Intended use
18 Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
Infinity M540
The Infinity M540 (M540) is intended for the moni-
toring of multi-parameter, physiologic patient infor-
mation obtained from connected hardware in
environments where patient care is provided by
trained healthcare professionals.The M540 is
intended to monitor one patient at a time.
The M540 and any connected hardware are not
intended for use in the following hospital environ-
ments:
– Hyperbaric chambers
– Environments containing MRI equipment
Indications for use
The M540 is capable of monitoring the following
parameters:
– Heart rate
– Arrhythmia (adult and pediatric only)
– 12-lead ECG monitoring including TruST
– ST segment analysis (adult and pediatric only)
– 12-lead ST segment analysis (adult and pediat-
ric only)
– Apnea
– Respiration rate
– Invasive blood pressure
– Non-invasive blood pressure
– Temperature
– Cardiac output (only available when the M540 is
docked in an IACS configuration)
– Arterial oxygen saturation (SpO2)
–Pulserate
– Mainstream etCO2
– Perfusion index (PI)
– Total hemoglobin (SpHb) – adult and pediatric
only
– Total oxygen content (SpOC)
– Carboxyhemoglobin saturation (SpCO) – adult
and pediatric only
– Methemoglobin saturation (SpMet)
– Pleth variability index (PVI)

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 19
System overview
System overview
Overview of Infinity M540 . . . . . . . . . . . . . . . 20
M540 front panel. . . . . . . . . . . . . . . . . . . . . . . . 21
M540 back panel . . . . . . . . . . . . . . . . . . . . . . . 22
M540 side panel . . . . . . . . . . . . . . . . . . . . . . . . 22
Infinity M500 docking station . . . . . . . . . . . . 23
M500 front panel. . . . . . . . . . . . . . . . . . . . . . . . 23
M500 back panel . . . . . . . . . . . . . . . . . . . . . . . 23
M540 docked in the M500 . . . . . . . . . . . . . . . . 24
Additional hardware. . . . . . . . . . . . . . . . . . . . 24
Device symbols . . . . . . . . . . . . . . . . . . . . . . . 26
Wireless symbols . . . . . . . . . . . . . . . . . . . . . . . 27
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 28

System overview
20 Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2
Overview of Infinity M540
These Instructions for Use describe the M540. This
monitor is a rugged, light-weight, handheld, trans-
portable patient monitor with a touch screen and
independent user interface. When docked in the
Infinity M500 (see page 49), the M540 is the signal
acquisition and data processing module for the
Infinity C500/C700, which is the primary display for
the Infinity Acute Care System (IACS).
The M540 also provides seamless patient monitor-
ing when it is undocked from the M500 for patient
transport (see page 49).
The M540 also comes with a wireless option that
allows it to transmit patient data to the ICS (Infinity
CentralStation) during transport.
Because the M540 is also part of an IACS configu-
ration, some of the IACS components are also
described here. For specific information regarding
the IACS, refer to Infinity Acute Care System –
Monitoring Applications Instructions for Use.
Some terms used in these Instructions for Use:
– Cockpit – refers to the Infinity C700 Medical
Cockpit or the Infinity C500 Medical Cockpit
which is the display module of the Infinity Acute
Care System
– M540 – refers to the Infinity M540 patient mon-
itor
– M500 – refers to the Infinity M500 that secures
the M540 and charges the internal battery of the
M540
– PS50 – refers to the M500 50-W power supply
– Docking the M540 – refers to placing the M540
on the M500
The M540 docked on an M500 can be set up as a
stand-alone configuration to charge the battery
when the M540 is not part of an IACS configuration.
The following diagram shows an M540 stand-alone
configuration. In addition, you can connect various
hardware to expand the monitoring capabilities.
AM540
BM500
CSystem cable (MS20345)
DPS50 power supply
EPS50 power cable
101
A
B
ED
C