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.