Dräger Infinity Acute Care System M540 User manual

Instructions for use
Infinity Acute Care System
Infinity M540 patient monitor
Software VG4.n
WARNING
To properly use this medical device,
read and comply with these instruc-
tions for use.

2 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
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 function key, Patient setup
represents 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.
Bullet 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 – Infinity M540 SW VG4.n 3
Trademarks
– 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®
– SET®
–SpCO
®
–SpHb
®
–SpMet
®
–SpOC
TM
– Pulse CO-Oximeter TM
– M-LNCS TM
are trademarks of Masimo corporation.
– Durasensor®
– Nellcor®
– OxiMax®
– OxiCliq®
–OxiBand
TM
–SoftCare
®
– SatSeconds®
are trademarks of Covidien.
– 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.

4 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
Safety information definitions
Definition of target groups
For this product, users, service personnel, and ex-
perts are defined as target groups.
These target groups must have received instruction
in the use of the product and must have the neces-
sary training and knowledge to use, install, repro-
cess, maintain, or repair the product.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined tar-
get groups.
Users
Users are persons who use the product in accor-
dance with its intended use.
Service personnel
Service personnel are persons who are responsible
for the maintenance of the product. Service person-
nel must be trained in the maintenance of medical
devices and install, reprocess, and maintain the
product.
Experts
Experts are persons who perform repair or complex
maintenance work on the product. Experts must
have the necessary knowledge and experience
with complex maintenance work on the product.
Abbreviations and symbols
For explanations, refer to the sections
"Abbreviations" on page 31 and "Symbols" on
page 28.
WARNING
A WARNING statement provides important in-
formation 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 – Infinity M540 SW VG4.n 5
For your safety and that of your patients
For your safety and that of your patients
Strictly follow these instructions for use . . . . . . 6
Storing the instructions for use . . . . . . . . . . . . . 6
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The medical device must be subject to regular
safety inspections. See chapter
"Maintenance". . . . . . . . . . . . . . . . . . . . . . . . . . 7
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Installing accessories . . . . . . . . . . . . . . . . . . . . 7
Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 7
Restrictions for use. . . . . . . . . . . . . . . . . . . . . . 7
Restriction of distribution . . . . . . . . . . . . . . . . . 7
Connected devices. . . . . . . . . . . . . . . . . . . . . . 7
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Device combinations . . . . . . . . . . . . . . . . . . . . 8
Connection to hospital network . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9
General safety information . . . . . . . . . . . . . . 9
Not for use in areas of explosion hazard . . . . . 11
Information on electromagnetic compatibility . . 11
Site of operation . . . . . . . . . . . . . . . . . . . . . . . . 11
Defibrillator precautions . . . . . . . . . . . . . . . . . . 12
Electrosurgery . . . . . . . . . . . . . . . . . . . . . . . . . 12

For your safety and that of your patients
6 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
Strictly follow these instructions for use Storing the instructions for use
Training
Training for users is available from the responsible
Dräger organization, see www.draeger.com.
Maintenance
NOTE
The Infinity Acute Care System provides the fol-
lowing additional instructions for use:
–Infinity Acute Care System – Monitoring appli-
cations (describes the Cockpit user interface
of the IACS)
–Infinity Acute Care System – Medical Cockpit
(describes the hardware of the Cockpit)
–Infinity Acute Care System – Monitoring ac-
cessories (describes all of the IACS accesso-
ries).
Please refer to these additional instructions for
use for device-specific information.
WARNING
Risk of incorrect operation and of incorrect
use.
Any use of the medical device requires full un-
derstanding and strict observation of all sec-
tions of these instructions for use. The medi-
cal device must only be used for the purpose
specified under ’Application’ and in conjunc-
tion with appropriate patient monitoring.
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device la-
bels. Failure to observe these safety informa-
tion statements constitutes a use of the medi-
cal device that is inconsistent with its intend-
ed use.
WARNING
Risk of incorrect use
Instructions for use must be kept accessible
for the user.
WARNING
Risk of medical device failure and of patient
injury.
The medical device must be inspected and
serviced regularly by service personnel. Re-
pair and complex maintenance carried out on
the medical device must be performed by ex-
perts.
If the above is not complied with, medical de-
vice failure and patient injury may occur. Ob-
serve chapter "Maintenance".
Dräger recommends that a service contract is
obtained with DrägerService and that all re-
pairs are performed by DrägerService. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.
WARNING
Any modification of this device or any use dif-
ferent from the one specified in these instruc-
tions for use may cause interference with oth-
er equipment or result in injury to the patient
or the user, including electric shock, burns or
death.

Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n 7
For your safety and that of your patients
Safety checks
The medical device must be subject to regular
safety inspections. See chapter "Maintenance".
Accessories
Installing accessories
Sterile accessories
Restrictions for use
Restriction of distribution
Federal Law (U.S.) restricts this device to sale by or
on the order of a physician.
Connected devices
Safe connection with other electrical
equipment
WARNING
Risk due to incompatible accessories.
Dräger has only tested the compatibility of ac-
cessories listed in the current list of accesso-
ries. If other accessories are used, there is a
risk of patient injury due to medical device fail-
ure. Dräger recommends that the medical de-
vice is only used with accessories listed in the
current list of accessories.
CAUTION
Risk of device failure
Install accessories to the basic device in accor-
dance with the instructions for use of the basic de-
vice. Make sure that there is a safe connection to
the basic device.
Strictly observe instructions for use and assembly
instructions.
WARNING
Disposable articles were developed, tested
and manufactured for disposable use only.
Disposable articles must not be reused, repro-
cessed, or sterilized. Reuse, reprocessing or
resterilization can lead to a failure of the ac-
cessories and cause injuries to the patient.
CAUTION
Device for use in health care environments only
and exclusively by persons as defined in the tar-
get groups (see "Maintenance" on page 6).
WARNING
Risk of electric shock and of device malfunc-
tion
Any connected devices or device combina-
tions not complying with the requirements
mentioned in these instructions for use can
compromise the correct functioning of the
medical device and lead to electric shock. Be-
fore operating the medical device, strictly
comply with the instructions for use of all con-
nected devices and device combinations.
WARNING
Risk of patient injury
Electrical connections to equipment not listed
in these instructions for use should only be
made following consultation with the respec-
tive manufacturers. Equipment malfunction
may result and pose a risk of patient injury.

For your safety and that of your patients
8 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying docu-
ments of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional state of the individual
devices can be compromised. The operating orga-
nization must ensure that the device combination
complies with the applicable editions of the relevant
standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards:
Third edition
– IEC 60601-1, third edition (general require-
ments for safety, device combinations, soft-
ware-controlled functions)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-8 (alarm systems)
Second edition
– IEC 60601-1, second edition (general require-
ments for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-4 (software-controlled functions)
– IEC 60601-1-8 (alarm systems)
If a device combination is not approved by Dräger,
proper operation of the devices can be compro-
mised.
The operator must ensure that the device combina-
tion meets the applicable standards.
Strictly observe instructions for use and assembly
instructions of all connected devices.
Strictly follow the assembly instructions and instruc-
tions for use for each connected device.
WARNING
Connecting devices to a multiple socket-out-
let (power strip) can result in increased elec-
tric leakage current and expose the user to
current beyond permissible values.
The leakage current also increases when mul-
tiple medical devices are connected to a pa-
tient. Make sure that the electrical isolation of
each device is suitable for the intended appli-
cation. Connect only equipment to the analog
and digital signal inputs and outputs that are
setup and tested according to IEC standards.
To protect the patient from possible injury due
to electrical shock, peripheral devices should
only be connected to a monitor within the
same room. The installer or service provider
should verify that the leakage current of the
interconnected system meets the electrical
safety requirements of IEC 60601-1. CAUTION
Combinations of Dräger devices and third-party
devices that are not approved by Dräger may ad-
versely affect operation of those devices and may
put the patient at greater risk of injury.
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 im-
pair operating safety. Responsibility for any such
modifications lies with the owner.

Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n 9
For your safety and that of your patients
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 80001-1 before attempting to
connect such medical devices to their IT networks.
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 re-
stricted to persons familiar with the most important
inherent characteristics of the medical device. In-
structions and WARNING and CAUTION state-
ments are therefore largely limited to the specifics
of the Dräger medical device.
These instructions for use do not contain any infor-
mation on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with dif-
ferent underlying diseases
Medical device modification or misuse can be dan-
gerous.
Patient monitoring
The user of the medical device is responsible for
choosing a suitable patient monitoring system that
provides appropriate information on medical device
performance and patient condition.
Patient safety may be achieved by a wide variety of
means ranging from electronic surveillance of med-
ical device performance and patient condition to di-
rect observation of clinical signs.
The responsibility for selecting the best level of pa-
tient monitoring lies solely with the user of the med-
ical device.
General safety information
The following WARNING and CAUTION state-
ments apply to general operation of the medical
device.WARNING and CAUTION statements spe-
cific 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 medical
device.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
WARNING
Follow local regulations for safe disposal of
batteries. To prevent fire or explosion, never
dispose of batteries in fire.
WARNING
Never use equipment that has been damaged
or compromised for patient monitoring.

For your safety and that of your patients
10 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
For countries subject to the EU directive
2002/96/EC
This device is subject to EU Directive 2002/96/EC
(WEEE). In order to comply with its registration ac-
cording to this directive, this device may not be dis-
posed of at municipal collection points for waste
electrical and electronic equipment. Dräger has au-
thorized a company to collect and dispose of this
device.
To initiate collection or for further information, visit
Dräger on the Internet at www.draeger.com. Use
the Search function with the keyword "WEEE" to
find the relevant information. If access to Dräger's
website is not possible, contact the local Dräger or-
ganization.
WARNING
To avoid electric shock, inspect all cables be-
fore use. Never use cables that appear
cracked, worn, or damaged in any way (doing
so may compromise performance or put the
patient at risk).
WARNING
To avoid risk of electric shock, this equipment
must only be connected to a main power
source with a protective earth ground.
WARNING
Do not cover the device with blankets or bed
sheets. To prevent burns to the patient, avoid
direct contact between external surfaces and
the patient.
WARNING
To avoid patient injury as the result of a falling
monitor when using a rolling stand, universal
bed hook, or handle hook mount, do not apply
excessive force to the monitor or mount when
entering or exiting elevators, or passing over
thresholds or uneven surfaces.
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. Re-
fer to the chapter entitled "Cleaning and disinfec-
tion" on page 291 for device-specific cleaning in-
structions. Moisture may damage the circuits,
compromise critical performance and present a
safety risk.
WARNING
Dräger recommends using the Infinity Acute
Care System or the M540 for primary diagno-
sis and the ICS (Infinity CentralStation) for pa-
tient viewing only.
WARNING
To prevent restriction of air flow to the device
and also prevent potential overheating, do not
allow the patient to come into direct contact
with system components for extended peri-
ods of time.

Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n 11
For your safety and that of your patients
Not for use in areas of explosion hazard
Information on electromagnetic
compatibility
General information on electromagnetic compatibil-
ity (EMC) according to international EMC standard
IEC 60601-1-2:
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 in-
formation provided on page 337.
Portable and mobile radio frequency communica-
tions equipment can affect medical electrical equip-
ment.
Site of operation
Only use devices (monitor, MPod, MCable, and ac-
cessories) in areas that meet the environmental re-
quirements outlined in the technical data section.
WARNING
Risk of fire
his medical device is neither approved nor
certified for use in areas where oxygen con-
centrations (combustible or explosive gas
mixtures) greater than 25% are likely to occur.
WARNING
When placing the device, make sure that ade-
quate airflow exists. To prevent overheating,
position the device with at least 5 cm (2 in) of
space all around.
WARNING
Do not connect connectors with
an ESD warning symbol and do
not touch their pins without imple-
menting ESD protective measures.
Such protective measures may in-
clude antistatic clothing and shoes, touching
a potential equalization pin before and during
connection of the pins, or using electrically in-
sulating and antistatic gloves. All users con-
cerned must be instructed in these ESD pro-
tective measures.
WARNING
To avoid interfering with device operation, do
not operate devices (monitor, MPod, MCable,
and accessories) close to equipment that
emits microwave or other high-frequency
emissions. For recommeded separation dis-
tances, see page 337 in the ’Electromagnetic
compatibility’ chapter.
WARNING
Periodically make sure that the device is prop-
erly 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 pan-
el of the devices.

For your safety and that of your patients
12 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
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.
Electrosurgery
Observe the following precautions during electro-
surgery to reduce electrosurgical unit (ESU) inter-
ference and improve operator and patient safety.
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 ac-
cidentally 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.
WARNING
To protect the patient during defibrillation and
to ensure accurate ECG information, use only
ECG electrodes and cables specified by
Dräger. Dräger recommends removing acces-
sories that are not rated for use during
defibrillation, such as disposable SpO2 sen-
sors. Use of defibrillation-proof accessories
can prevent sensor breakdown and prevent
defibrillation energy from being diverted away
from the patient.
CAUTION
To prevent burns and electric shock due to the re-
routing of electrical current through electrodes, do
not position the defibrillator pads near any elec-
trodes or sensors.
CAUTION
Only defibrillate across the chest.
WARNING
For better performance and to reduce the haz-
ard of burns during surgery, always use ac-
cessories 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 (e.g.,
ECG, SpO2pressure ) and their associated ca-
bles away from the surgical site, the ESU re-
turn electrode, and earth ground.
NOTE
Cover internally placed reusable temperature
sensors with temperature probe sheaths.
WARNING
To reduce the hazard of burns during electro-
surgery, do not use four-lead extension cables
in electrosurgical environments.

Instructions for use Infinity Acute Care System -- Infinity M540 SW VG4.n 13
Contents
Contents
For your safety and that of your patients. . . 5
General safety information . . . . . . . . . . . . . . . . 9
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Indications for use . . . . . . . . . . . . . . . . . . . . . . 19
Functional safety . . . . . . . . . . . . . . . . . . . . . . . 19
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
M500 docking station . . . . . . . . . . . . . . . . . . . . 25
Additional hardware . . . . . . . . . . . . . . . . . . . . . 26
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Operating concept . . . . . . . . . . . . . . . . . . . . . 33
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
M540 in standalone / wireless mode . . . . . . . . 34
M540 in an IACS configuration. . . . . . . . . . . . . 37
Communicating with the Infinity network . . . . . 37
ICS (Infinity CentralStation) communication . . . 38
Remote view and remote control . . . . . . . . . . . 41
Function keys . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Monitoring area. . . . . . . . . . . . . . . . . . . . . . . . . 44
Adjusting the display. . . . . . . . . . . . . . . . . . . . . 48
Battery power . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Power-saving mode . . . . . . . . . . . . . . . . . . . . . 50
Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Saving a profile. . . . . . . . . . . . . . . . . . . . . . . . . 63
Profile behavior in an IACS configuration. . . . . 63
Profile behavior in a standalone configuration . 64
Standby mode. . . . . . . . . . . . . . . . . . . . . . . . . . 66
Privacy mode . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Recordings/reports . . . . . . . . . . . . . . . . . . . . . . 67
Assembly and preparation . . . . . . . . . . . . . . 69
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Docking/undocking the M540 . . . . . . . . . . . . . . 71
Locking/unlocking the M540. . . . . . . . . . . . . . . 72
Connecting the system cables in an IACS
configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Connecting the system cable in an M540
stand-alone configuration . . . . . . . . . . . . . . . . 73
Mounting the Infinity MCable – Masimo SET
and Masimo rainbow SET/Nellcor OxiMax . . . 74
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 77
Overview of monitoring a patient. . . . . . . . . . . 78
Turning the M540 on/off . . . . . . . . . . . . . . . . . 78
Admitting a patient. . . . . . . . . . . . . . . . . . . . . . 79
Discharging a patient. . . . . . . . . . . . . . . . . . . . 80
Patient categories . . . . . . . . . . . . . . . . . . . . . . 81
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Overview of alarms . . . . . . . . . . . . . . . . . . . . . 84
Alarm priorities . . . . . . . . . . . . . . . . . . . . . . . . 84
Alarm processing. . . . . . . . . . . . . . . . . . . . . . . 85
Activating or deactivating alarm validation . . . 86
Visual alarm signals . . . . . . . . . . . . . . . . . . . . 87
Acoustic alarm signals. . . . . . . . . . . . . . . . . . . 88
Testing visual and acoustic alarm signals . . . . 90
Special alarm behavior . . . . . . . . . . . . . . . . . . 91
Pre-silencing alarms . . . . . . . . . . . . . . . . . . . . 94
Pausing acoustic alarm signals (audio pause) 95
Pausing alarm monitoring temporarily. . . . . . . 97
Activating or deactivating alarm monitoring. . . 98
Configuring a patient’s alarm settings . . . . . . . 98
Event recall . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Viewing a snapshot of a single event . . . . . . . 104
Configuring the SpO2alarm priority. . . . . . . . . 105
Alarm management setup (password-
protected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
The Code function key . . . . . . . . . . . . . . . . . . 106
Alarm groups . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Alarm ranges and defaults . . . . . . . . . . . . . . . 107
Impedance respiration (RRi). . . . . . . . . . . . 115
Overview of respiration monitoring . . . . . . . . . 116
RRi precautions. . . . . . . . . . . . . . . . . . . . . . . . 116
Connecting the 3-, 5-, 6-lead wire sets for
respiration monitoring . . . . . . . . . . . . . . . . . . . 117
Connecting the lead wire sets for 12-lead
respiration monitoring . . . . . . . . . . . . . . . . . . . 118

Contents
14 Instructions for use Infinity Acute Care System -- Infinity M540 SW VG4.n
Connecting the lead wires for neonatal
respiration monitoring. . . . . . . . . . . . . . . . . . . . 119
Patient preparation for respiration monitoring . 120
Respiration display . . . . . . . . . . . . . . . . . . . . . . 122
Respiration measuring modes . . . . . . . . . . . . . 123
Accessing the respiration dialog window . . . . . 123
Respiration parameter setup functions. . . . . . . 124
ECG, arrhythmia, and ST segment . . . . . . . . 127
Overview of ECG and heart rate monitoring . . 129
ECG precautions . . . . . . . . . . . . . . . . . . . . . . . 130
Connecting the 3-, 5-, 6-lead wire sets for
ECG monitoring . . . . . . . . . . . . . . . . . . . . . . . . 131
Connecting the lead wire sets for 12-lead
ECG monitoring . . . . . . . . . . . . . . . . . . . . . . . . 132
Connecting the lead wires for neonatal ECG
monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Patient preparation for ECG monitoring . . . . . . 134
ECG display . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
ECG electrode colors . . . . . . . . . . . . . . . . . . . . 136
Electrode placement. . . . . . . . . . . . . . . . . . . . . 137
12-lead monitoring . . . . . . . . . . . . . . . . . . . . . . 140
Accessing the ECG dialog window. . . . . . . . . . 141
ECG parameter setup functions . . . . . . . . . . . . 141
Monitoring paced patients . . . . . . . . . . . . . . . . 144
Pacemaker precautions . . . . . . . . . . . . . . . . . . 145
Optimizing pacer processing . . . . . . . . . . . . . . 147
Arrhythmia monitoring overview . . . . . . . . . . . . 147
Selecting arrhythmia leads . . . . . . . . . . . . . . . . 148
Arrhythmia processing . . . . . . . . . . . . . . . . . . . 149
Arrhythmia modes . . . . . . . . . . . . . . . . . . . . . . 149
Arrhythmia display . . . . . . . . . . . . . . . . . . . . . . 151
Accessing the arrhythmia dialog window . . . . . 152
Arrhythmia parameter setup functions . . . . . . . 152
Monitoring ST overview . . . . . . . . . . . . . . . . . . 153
Standard ST monitoring . . . . . . . . . . . . . . . . . . 153
TruST 12-lead monitoring. . . . . . . . . . . . . . . . . 154
12-Lead ST monitoring. . . . . . . . . . . . . . . . . . . 154
Connecting lead wire sets for ST monitoring . . 155
ST display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
ST complex dialog windows . . . . . . . . . . . . . . . 156
ST measuring points . . . . . . . . . . . . . . . . . . . . 157
ST reference. . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Accessing the ST dialog window . . . . . . . . . . . 158
ST setup functions . . . . . . . . . . . . . . . . . . . . . . 158
Learning/relearning QRS pattern . . . . . . . . . . . 160
SpO2and Pulse CO-Ox monitoring with
Masimo SET MCable . . . . . . . . . . . . . . . . . . . 161
Overview of SpO2monitoring . . . . . . . . . . . . . 162
SpO2and Pulse CO-Ox precautions. . . . . . . . 164
Connecting the Masimo SET MCable . . . . . . . 167
Connecting the Masimo rainbow SET
MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Patient preparation . . . . . . . . . . . . . . . . . . . . . 169
SpO2and Pulse CO-Ox display . . . . . . . . . . . 170
Accessing the SpO2dialog window. . . . . . . . . 172
SpO2parameter setup functions . . . . . . . . . . . 173
Pulse CO-Ox parameter setup functions. . . . . 175
Password-protected Masimo rainbow SET
setup functions . . . . . . . . . . . . . . . . . . . . . . . . 177
SpO2and pulse rate monitoring with
Nellcor OxiMax MCable. . . . . . . . . . . . . . . . . 179
Overview of SpO2monitoring . . . . . . . . . . . . . 180
SpO2precautions . . . . . . . . . . . . . . . . . . . . . . 180
Connecting the Nellcor OxiMax MCable . . . . . 182
Patient preparation for SpO2monitoring . . . . . 183
SpO2display . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Accessing the SpO2dialog window. . . . . . . . . 184
SpO2parameter setup functions . . . . . . . . . . . 185
Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . 187
Overview of temperature monitoring . . . . . . . . 188
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Connecting the temperature sensors . . . . . . . 188
Temperature display . . . . . . . . . . . . . . . . . . . . 191
Accessing the temperature dialog window . . . 192
Temperature parameter setup functions . . . . . 192
Non-invasive blood pressure (NIBP) . . . . . . 193
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Non-invasive blood pressure precautions . . . . 195
Patient preparation for non-invasive blood
pressure monitoring. . . . . . . . . . . . . . . . . . . . . 197
Non-invasive blood pressure display. . . . . . . . 198
Non-invasive blood pressure measurement
modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Venous stasis . . . . . . . . . . . . . . . . . . . . . . . . . 201
Accessing the non-invasive blood pressure
dialog window . . . . . . . . . . . . . . . . . . . . . . . . . 202
Non-invasive blood pressure parameter setup
functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Instructions for use Infinity Acute Care System -- Infinity M540 SW VG4.n 15
Contents
Invasive blood pressure (IBP) . . . . . . . . . . . . 205
Overview of invasive blood pressure
monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Invasive blood pressure precautions . . . . . . . . 208
Connecting the Hemo4 and Hemo2 pods . . . . 209
Connecting the MPod – QuadHemo. . . . . . . . . 210
Connecting the Dual Hemo MCable. . . . . . . . . 211
Patient preparation for invasive blood
pressure monitoring . . . . . . . . . . . . . . . . . . . . . 212
Invasive blood pressure display . . . . . . . . . . . . 212
Labeling Invasive blood pressure channels . . . 213
Standard pressure labels . . . . . . . . . . . . . . . . . 214
Pressure label conflicts. . . . . . . . . . . . . . . . . . . 215
Zeroing an invasive blood pressure
transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Pulmonary wedge pressure . . . . . . . . . . . . . . . 217
Accessing the invasive blood pressure
dialog window. . . . . . . . . . . . . . . . . . . . . . . . . . 217
Invasive blood pressure parameter setup
functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Cardiac output . . . . . . . . . . . . . . . . . . . . . . . . 219
Overview of cardiac output monitoring . . . . . . . 220
Cardiac output precautions. . . . . . . . . . . . . . . . 220
Connecting the cardiac output hardware . . . . . 221
Patient preparation for cardiac output
monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
Carbon dioxide concentrations. . . . . . . . . . . 225
Overview of CO2monitoring. . . . . . . . . . . . . . . 226
CO2precautions. . . . . . . . . . . . . . . . . . . . . . . . 226
Connecting the CO2sensor . . . . . . . . . . . . . . . 228
Patient preparation for CO2monitoring . . . . . . 229
CO2display . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
Accessing the CO2dialog window . . . . . . . . . . 232
CO2parameter setup functions . . . . . . . . . . . . 232
System configuration. . . . . . . . . . . . . . . . . . . 235
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Configuring general settings. . . . . . . . . . . . . . . 237
Configuring the patient settings . . . . . . . . . . . . 239
Configuring the system settings . . . . . . . . . . . . 240
Viewing the system information . . . . . . . . . . . . 246
Configuring the biomed settings . . . . . . . . . . . . 248
Configuring the screen setup . . . . . . . . . . . . . . 254
Configuring alarm settings . . . . . . . . . . . . . . . . 255
Configuring the battery alarm . . . . . . . . . . . . . . 257
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 261
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262
Device communication messages / general
device messages. . . . . . . . . . . . . . . . . . . . . . . 262
M540 battery messages . . . . . . . . . . . . . . . . . 264
Banners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
ST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
Respiration (RRi) . . . . . . . . . . . . . . . . . . . . . . 270
SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
Non-invasive blood pressure. . . . . . . . . . . . . . 276
Cardiac output . . . . . . . . . . . . . . . . . . . . . . . . . 278
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . 279
Invasive blood pressure . . . . . . . . . . . . . . . . . 280
CO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . 285
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . 287
Inspection / safety checks . . . . . . . . . . . . . . . . 288
Preventive maintenance . . . . . . . . . . . . . . . . . 289
Cleaning and disinfection. . . . . . . . . . . . . . . 291
Overview of cleaning and disinfecting the
M540 and its accessories . . . . . . . . . . . . . . . . 292
Approved cleaning agents. . . . . . . . . . . . . . . . 293
Cleaning and disinfecting the M540 and
M500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
Cleaning and disinfecting an MCable and
MPod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
Cleaning and disinfecting patient cables . . . . . 296
Cleaning and disinfecting reusable ECG lead
wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
Cleaning and disinfecting temperature
sensors and cables . . . . . . . . . . . . . . . . . . . . . 297
Cleaning non-invasive blood pressure cuffs . . 298
Cleaning and disinfecting invasive blood
pressure transducers and hemodynamic
pods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298
Cleaning and disinfecting mainstream CO2
sensors and airway adapters . . . . . . . . . . . . . 299

Contents
16 Instructions for use Infinity Acute Care System -- Infinity M540 SW VG4.n
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
EU Directive 2002/96/EC (WEEE) . . . . . . . . . . 301
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 303
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304
System compatibility. . . . . . . . . . . . . . . . . . . . . 304
Infinity M540 . . . . . . . . . . . . . . . . . . . . . . . . . . . 305
Infinity M500 . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
Power supply (PS50). . . . . . . . . . . . . . . . . . . . 309
120 Watt desktop power supply (PS120) . . . . . 310
Infinity MCable – Mainstream CO2 . . . . . . . . . 311
Infinity MCable – Masimo SET and Infinity
MCable – Masimo rainbow SET. . . . . . . . . . . . 312
Infinity MCable – Nellcor OxiMax . . . . . . . . . . . 313
Infinity Hemo2 and Hemo4 pods . . . . . . . . . . . 314
Infinity MPod – Quad Hemo . . . . . . . . . . . . . . . 315
Infinity MCable – Dual Hemo . . . . . . . . . . . . . . 316
Infinity MCable – Analog/Sync . . . . . . . . . . . . . 317
Infinity MCable – Nurse call . . . . . . . . . . . . . . . 319
Parameter monitoring specifications . . . . . . . . 320
Electromagnetic compatibility . . . . . . . . . . . . . . 337
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341

Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n 17
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Indications for use . . . . . . . . . . . . . . . . . . . . . 19
Functional safety . . . . . . . . . . . . . . . . . . . . . . 19

Application
18 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
Intended use
The Infinity M540 (M540) is intended for the moni-
toring of multi-parameter, physiologic patient infor-
mation obtained from connected hardware in envi-
ronments where patient care is provided by trained
health care professionals. The M540 is intended to
monitor one patient at a time.
The M540 and any connected hardware are not in-
tended for use in the following hospital environ-
ments:
– Hyperbaric chambers
– Environments containing MRI equipment
This device is neither approved nor certified for use
in areas where oxygen concentrations are greater
than 25% or where explosive gas mixtures are like-
ly to occur.
NOTE
The Dräger wireless 802.11 b/g radio card com-
plies with part 15 of the FCC rules. Operation is
subject to the following two conditions:
– This device may not cause harmful interfer-
ence.
– This device must accept any interference re-
ceived, including interference that may cause
undesired operation.

Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n 19
Application
Indications for use
The M540 is capable of monitoring the following pa-
rameters:
– Heart rate
– Arrhythmia (adult and pediatric patients only)
–12-leadECG monitoring
– TruST monitoring (adult and pediatric patients
only)
–ST segment analysis (adult and pediatric pa-
tients only)
–12-leadST segment analysis (adult and pediat-
ric only)
– Apnea
– Respiration rate – RRi
– Invasive blood pressure – IBP
– Non-invasive blood pressure – NIBP
– Temperature
– Cardiac output – only available when the M540
is docked in an IACS configuration (adult and
pediatric patients only)
– Arterial oxygen saturation – SpO2
– Pulse rate
– Mainstream etCO2
– Perfusion index – PI
– Total hemoglobin – SpHb, (adult and pediatric
patients only)
– Total oxygen content – SpOC, (adult and pedi-
atric patients only)
– Carboxyhemoglobin saturation – SpCO
– Methemoglobin saturation – SpMet
– Pleth variability index – PVI
Functional safety
The essential performance of a patient monitor is to
provide a clinician with meaningful parameter val-
ues and alarm annunciation when the established
parameter limits have been exceeded or the ability
to provide values is compromised. Risks associat-
ed with use of the monitor in light of these essential
performance functions have been evaluated and
mitigations implemented so that the residual risk is
as low as reasonably practicable, provided routine
maintenance and service recommendations are fol-
lowed throughout the life of the product.

20 Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
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