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.