Dräger Infinity Acute Care System User manual

Instructions for use
Infinity®Acute Care System
Infinity®Medical Cockpits
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®Medical Cockpits
Typographical conventions
Illustrations
Illustrations of products and screen content in this
document may differ from the actual products
depending on configuration and design.
Use of terms
Dräger uses the term "accessories" not only for
accessories in the sense of IEC 60601-1, but also
for consumables, removable parts, and attached
parts.
Trademarks
Trademarks owned by Dräger
The trademarks are registered in the following
countries:
Trademarks owned by third-party
manufacturers
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.
> The greater-than symbol indicates the naviga-
tion path in a dialog window.
Bold, italicized text indicates labels on the de-
vice and texts that are displayed on the screen.
Trademark Country
Infinity®EU, USA, Australia
Trademark Trademark owner
Actichlor®Ecolab
BruTab 6S®Brulin
Dispatch®Clorox
Buraton®Schülke & Mayr
Mikrozid®
Perform®
acryl-des®
Descogen®Antiseptica
Dismozon®BODE Chemie
Klorsept®Medentech
Oxycide®Ecolab USA
Virkon®DuPont
Trademark Trademark owner

Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 3
Safety information defintions
Abbreviations and symbols
Refer to "Symbols" and "Abbreviations" on page 22
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.

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Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 5
Contents
Contents
For your safety and that of your patients. . . 7
General safety information . . . . . . . . . . . . . . . . 8
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of use. . . . . . . . . . . . . . . . . . . . . . 16
System overview . . . . . . . . . . . . . . . . . . . . . . 17
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Back panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Hardware features . . . . . . . . . . . . . . . . . . . . . 23
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Alarm Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
LEDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Mounting solutions . . . . . . . . . . . . . . . . . . . . . . 28
Operating concept . . . . . . . . . . . . . . . . . . . . . 29
User interface . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Layout elements . . . . . . . . . . . . . . . . . . . . . . . . 30
Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Customizing the display . . . . . . . . . . . . . . . . . . 35
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 37
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Information on reprocessing . . . . . . . . . . . . . . . 38
Classifications for reprocessing . . . . . . . . . . . . 39
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 40
Reprocessing procedures. . . . . . . . . . . . . . . . . 40
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Maintenance of the Cockpit . . . . . . . . . . . . . . . 45
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Safety inspections . . . . . . . . . . . . . . . . . . . . . . 46
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Disposing of the medical device . . . . . . . . . . . 48
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 49
Infinity C500/C700. . . . . . . . . . . . . . . . . . . . . . 50
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 52
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 57
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

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Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 7
For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . . 8
Strictly follow these instructions for use . . . . . . 8
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Not for use in areas of explosion hazard or
oxygen-enriched atmospheres . . . . . . . . . . . . . 9
Connected devices. . . . . . . . . . . . . . . . . . . . . . 9
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Connection to IT network . . . . . . . . . . . . . . . . . 9
Device combinations . . . . . . . . . . . . . . . . . . . . 9
Storing the instructions for use . . . . . . . . . . . . . 10
Electromagnetic compatibility (EMC) . . . . . . . . 10
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Duties of the operating organization. . . . . . . . . 13
Description of target groups . . . . . . . . . . . . . . . 13

For your safety and that of your patients
8 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
General safety information
The following WARNING and CAUTION
statements 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.
Strictly follow these instructions for use
Maintenance
Accessories
WARNING
Risk of incorrect operation and of incorrect
use
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 16.
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety infor-
mation statements constitutes a use of the
medical device that is inconsistent with its
intended use.
WARNING
Risk of medical device failure and of patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
Dräger recommends that a service contract is
obtained with Dräger-authorized service per-
sonnel and that all repairs are performed by
Dräger-authorized service personnel. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.
NOTE
Dräger will submit all documents needed for repair
on request.
WARNING
Risk due to incompatible accessories
The use of incompatible accessories may ad-
versely affect the functional integrity of the
product. Personal injury and property damage
may occur as a consequence.
Use only compatible accessories. The acces-
sories that are compatible with this product
are listed in the list of accessories supplied
with the product.

Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 9
For your safety and that of your patients
Not for use in areas of explosion hazard
or oxygen-enriched atmospheres
Connected devices
Safe connection with other electrical
equipment
Connection to IT network
The medical device has interfaces to connect to
other devices or components. These interfaces are
only suitable for connecting devices or connecting
to networks that have the physical characteristics
described on page 11 and page 50.
For software-related requirements on the
connection of devices or networks to these
interfaces observe the relevant documents of these
applications.
If the Cockpit is used to send or distribute alarm
conditions to another device and that system is not
able to be a “distributed alarm system with
confirmed delivery of alarm conditions” as per IEC
60601-1-8:2006 +A1:2012, cl. 6.11.2.2, then the
corresponding remote part of the system shall be
labeled with a warning that it shall not be relied
upon for receipt of alarm signals.
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying
documents 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
organization 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 (if
applicable):
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software con-
trolled functions)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-8 (alarm systems)
Strictly follow the assembly instructions and
instructions for use.
The Infinity Acute Care System -
Infinity Medical Cockpits have no essential
performance as defined in IEC 60601-1.
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur or in oxygen-
enriched atmospheres.
WARNING
Risk of electric shock and of device failure
Any connected devices or device combina-
tions not complying with the requirements
mentioned in these instructions for use may
compromise the correct functioning of the
medical device. Before operating any combi-
nation of devices, refer to and strictly comply
with the instructions for use for all connected
devices and device combinations.
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these instructions for use must only be made
when approved by each respective manufacturer.

For your safety and that of your patients
10 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
Any essential performance in combination with an
application using the Infinity Medical Cockpits is
listed in the accompanying user documentation of
that application.
Storing the instructions for use
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility. During installation
and before initial operation, follow the information in
section: "EMC declaration" (page 52).
This device can be affected by other electrical
devices.
Portable and mobile RF communications
equipment can affect medical electrical equipment.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g.,
cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical
devices) emit electromagnetic radiation.
When such devices are operated too close to
this device or its cables, the functional
integrity of this device may be compromised
by electromagnetic disturbances. As a result,
the patient could be put at risk.
Maintain a distance of at least 0.3 m (1.0 ft)
between this device and wireless
communication devices, to ensure that the
essential performance of this device is
fulfilled.
Maintain an adequate distance between this
device and other medical electrical
equipment.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against elec-
trostatic discharge are employed in the follow-
ing situations:
– When touching the pins of connectors that
carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the follow-
ing measures and train the relevant person-
nel:
– Observe the ESD protective measures.
Such measures may include wearing anti-
static clothing and shoes, touching a po-
tential equalization pin before and while
making the connection, or using electrical-
ly insulating and antistatic gloves.
– Observe the requirements for the electro-
magnetic environment. Observe the fol-
lowing section: "Electromagnetic environ-
ment" (page 53).

Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 11
For your safety and that of your patients
WARNING
Risk of electric shock
Do not connect connectors with an
ESD warning symbol and do not
touch their pins without imple-
menting ESD protective measures. Such pro-
tective measures can include antistatic
clothing and shoes, touching a potential
equalization pin before and during connection
of the pins, or using electrically insulating and
antistatic gloves.
All users concerned must be instructed in
these ESD protective measures.
WARNING
Risk due to modifications
Modifications to the product may lead to mal-
functions and unforeseen risks. This may re-
sult in injury to the patient or the user or in
property damage.
Do not modify this product.
WARNING
No hardware modification is allowed without
the consent of the manufacturer. Hardware
modifications could compromise the safe
electrical and functional use of the product. If
the software of the product is modified
according to these instructions for use,
appropriate inspection and testing must be
conducted to make sure, the equipment is
safe to use.
WARNING
To ensure that the device is properly
grounded, connect the power cable to a hos-
pital-grade outlet.
WARNING
The Infinity Medical Cockpits are not suitable
for use in the presence of oxygen-enriched
atmospheres or flammable anesthetic mix-
tures.
WARNING
Because of the risk of electric shock, never
remove the cover of a device while it is in
operation or connected to a mains power
socket.
WARNING
Do not operate the device in areas such as:
magnetic resonance imaging (MRI) environ-
ments, aircraft, ambulance, home or hyper-
baric chambers.
WARNING
Connect only equipment to the analog and
digital interfaces (signal inputs and outputs)
of which the connected circuit has max.
24 VDC (max. 30 VDC for the system cable)
and is either a touchable SELV circuit accord-
ing to IEC 60950 or double insulated against
primary circuits according to IEC 60601-1.
Connect only passive (not separately ener-
gized) USB devices.
Any devices, or combination of devices, not
complying with the requirements mentioned
in these instructions for use may compromise
the correct functioning of the
Infinity Medical Cockpits. Prior to operating
the Infinity Medical Cockpits, consult the
respective documentation and instructions
for use of all connected devices or combina-
tion of devices.
Anyone connecting additional devices to the
signal input or output may configure a medi-
cal electrical system, and is therefore respon-
sible for ensuring that the system complies
with IEC 60601-1 (3rd edition, clauses 14 and
16) or IEC 60601-1-1 with IEC 60601-1-4, and
IEC 60601-1-2 and IEC 60601-1-8. If you have
any questions, contact Dräger-authorized ser-
vice personnel.

For your safety and that of your patients
12 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
Virus protection
Service
WARNING
USB equipment must be non-touchable by the
patient because of possible touch currents
flowing between the Cockpit housing and the
housing of the USB device.
WARNING
The table mount (part number MS13222, IACS
monitoring applications only) is not intended
for transport. Tilting the table mount beyond 5
degrees can affect the stability of the
Infinity Medical Cockpits and cause them to
fall.
WARNING
To avoid short-circuiting and otherwise dam-
aging the device, do not allow fluids to come
in contact with the device. If fluids are acci-
dentally spilled on the equipment, remove the
affected unit from service as soon as possible
and contact the service personnel to verify
that patient safety is not compromised.
WARNING
Avoid direct contact between the external sur-
faces of the device and the patient.
WARNING
When mounting the device, make sure the
requirements for maximum load and slope of
floor are met. Consult the mounting manufac-
turer’s documentation for detailed informa-
tion.
CAUTION
When placing the device, make sure adequate
ventilation exists and prevent overheating by
positioning these items with at least 2 inches
(5 cm) of space around all sides if possible.
CAUTION
To avoid damaging the touch-sensitive screen, do
not allow sharp instruments to touch the front
access panel of the Infinity Medical Cockpits.
CAUTION
The device should only be operated in surround-
ings that meet the environmental operating tem-
peratures specified on page 51.
CAUTION
To prevent overheating, do not place the
Infinity Medical Cockpits in direct sunlight or near
radiant heaters.
CAUTION
Do not obstruct or close off the vents on the med-
ical device. Air must be able to enter freely. Other-
wise the medical device may become too hot. An
alarm is triggered if the medical device overheats
during operation.
CAUTION
After extended exposure in a cold environment,
take special care to acclimate the device so con-
densation does not form on the electronic parts
which could lead to damage.
CAUTION
The Infinity Medical Cockpit does not have virus
protection software and relies therefore on the
firewall of your institution to prevent access to
infected files. While setting up IT applications to
access web sites, evaluate each web site with
regard to possible virus infection.
WARNING
Risk if service is not performed regularly
If service is not performed regularly, malfunc-
tions may occur, which can result in personal
injury and property damage.
Perform the service in accordance with the
chapter "Maintenance".

Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 13
For your safety and that of your patients
Duties of the operating organization
The tasks described in this document specify the
requirements that have to be met by each
respective target group.
The operating organization of this product must
ensure the following:
– The target group has the required qualifications
(e.g., has undergone specialist training or ac-
quired specialist knowledge through experi-
ence).
– The target group has been trained to perform
the task.
– The target group has read and understood the
chapters required to perform the task.
Description of target groups
The target groups may only perform the following
tasks if they meet the corresponding requirements.
User
Reprocessing personnel
Service personnel
Specialized service personnel
Dräger recommends arranging a service contract
with Dräger-authorized service personnel.
Task Requirement
Use of the product in
accordance with the
intended use
Specialist medical knowl-
edge in the use of the prod-
uct
Task Requirement
Reprocessing Specialist knowledge in the
reprocessing of medical
devices
Task Requirement
Installation Specialist knowledge in
electrical engineering and
mechanics
Experience in the servicing
of medical devices
Basic service work
(inspection, mainte-
nance according to
the "Maintenance"
chapter)
Task Requirement
Installation Specialist knowledge in
electrical engineering and
mechanics
Experience in the servicing
of medical devices
Experience in complex ser-
vice work on this product
Basic and complex
service work (in-
spection, mainte-
nance, repair)

14 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
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Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 15
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of use . . . . . . . . . . . . . . . . . . . . 16

Application
16 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
Intended use
The Infinity Medical Cockpits, consisting of the
C500, and the C700 are monitoring and control
displays for the Infinity Acute Care System (IACS).
Medical Cockpits are intended to be used to
monitor waveforms, parameter information, and
alarms as well as to control settings. The Infinity
Series Medical Cockpits are intended to be used in
environments where patient care is provided by
trained healthcare professionals.
Environment of use
The specification of the device environment is
classified as pollution degree 2 (non-conductive
pollution only).
The device shall only be connected with its power
supply to the mains with overvoltage category 2.
The device shall only be connected to
telecommunication networks with overvoltage
category 1 (peak transient voltage below 1500V
according to IEC 60950-1 (chapter G.3, chapter
2.3.1a, chapter 1.2.13.8)).
WARNING
Risk of explosion and fire
This medical device is neither approved nor
certified for use in areas where oxygen con-
centrations greater than 25 %, combustible or
explosive gas mixtures are likely to occur.

Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 17
System overview
System overview
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Back panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 22

System overview
18 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
Overview
These instructions for use provide a general over-
view of the Infinity Medical Cockpits. Specifically,
these instructions for use describe the common
user-interface and hardware components for the
Infinity Medical Cockpits when used with different
application software. Specifically, this document
addresses the following topics:
– Common hardware components (for example,
the rotary knob and the alarm bar)
– Common user-interface strategy (for example,
navigational tools)
– Technical specifications
This document does not describe the actual func-
tions of an Infinity Medical Cockpit when it is con-
nected to a specific software application. For such
detailed instructions, refer to the instructions for
use of the application software.
The Infinity Medical Cockpits are the central user-
interface and processing center for the various
applications of the Infinity Acute Care System.

Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits 19
System overview
Front panel
AAlarm bar (use depends on application). Lights
up during alarm conditions in the respective
alarm color.
BAudio pause key (use depends on application).
CRotary knob (use depends on application). The
light inside the rotary knob lights up yellow when
you have to press on the rotary knob to confirm
an action.
DAmbient light sensor (use depends on applica-
tion).
EBattery LED. Indicates battery status (only sup-
ported if the medical device features a backup
battery).
FAC power LED. Lights up when the device is
connected to AC power.
GPower On/Off key
HPower on LED
C500_Front
A
B
C
G F E D
H

System overview
20 Instructions for use - Infinity®Acute Care System - Infinity®Medical Cockpits
Back panel
AAlarm bar (use depends on application)
BVESA mounting
C2x USB 2.0 port
DSystem cable port
E3x Serial communication port RS232 (COM),
isolated
FCooling vents
G2x LAN 10/100/1000 Mbps, isolated
H3x USB 2.0 port
I1x USB 3.0 port
J2x DisplayPort connections
K1x USB 3.0 port
C500_Back
AB
HE
G
J
KC
D
IF