Dräger Polaris Multimedia User manual

Polaris Multimedia
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
en Instructions for use, page 3
ro Instrucţiuni de utilizare, pagina 51
bg Pъководство за работа, стр. 100
el Οδηγίες χρήσης, σελίδα 149
tr Kullanm kılavuzu, sayfa 198

2 Instructions for use Polaris Multimedia
This page has been left blank intentionally.

Instructions for use Polaris Multimedia 3
Information on the instructions for use
Information on the instructions for use
Typographical conventions
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet points indicate individual actions or
different 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.
Bold, italicized text indicates labels on the
device.
Regional availability
Some components may not be available in every
country. Please contact your local contact person
for further information.
The following web page lists the local contact
persons: www.draeger.com
Trademarks
Trademarks owned by Dräger
The following web page provides a list of the
countries in which the trademarks are registered:
www.draeger.com/trademarks
Trademark
Polaris®
en
Instructions for use

Information on the instructions for use
4 Instructions for use Polaris Multimedia
Safety information definitions
Target groups
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
acquired specialist knowledge through
experience).
– 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.
Users
This target group includes healthcare professionals
such as surgeons and OR nurses.
WARNING
A WARNING statement provides important in-
formation about a potentially hazardous situa-
tion 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.
Task Requirement
Use of the product in
accordance with the
intended use
Training in a relevant
healthcare field or in a
medical discipline and
knowledge of the use of the
product

Instructions for use Polaris Multimedia 5
Information on the instructions for use
Reprocessing personnel
This target group includes persons who are
responsible for the reprocessing of medical
devices.
Service personnel
Specialized service personnel
Dräger recommends arranging a service contract
with DrägerService.
Abbreviations and symbols
For explanations refer to sections "Abbreviations"
and "Symbols" in chapter "Overview".
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 activi-
ties (inspection,
maintenance ac-
cording to the "Main-
tenance" chapter)
Task Requirement
Installation Specialist knowledge in
electrical engineering and
mechanics
Experience in the servicing
of medical devices
Training in service activi-
ties on this product
Basic and complex
service activities (in-
spection, mainte-
nance, repair)

Contents
6 Instructions for use Polaris Multimedia
Contents
Information on the instructions for use . . . . 3
Typographical conventions. . . . . . . . . . . . . . . . 3
Regional availability . . . . . . . . . . . . . . . . . . . . . 3
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Safety information definitions . . . . . . . . . . . . . . 4
Target groups . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety-related information. . . . . . . . . . . . . . . 7
General safety information . . . . . . . . . . . . . . . . 7
Product-specific safety information . . . . . . . . . 11
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Maximum load . . . . . . . . . . . . . . . . . . . . . . . . . 13
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Display mounts. . . . . . . . . . . . . . . . . . . . . . . . . 15
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Position of the information signs . . . . . . . . . . . 17
Assembly and preparation . . . . . . . . . . . . . . 18
Checking for operational readiness before
each use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Preparing the display . . . . . . . . . . . . . . . . . . . . 19
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Positioning a display. . . . . . . . . . . . . . . . . . . . . 24
Fault – Cause – Remedy . . . . . . . . . . . . . . . . 26
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 27
Safety information . . . . . . . . . . . . . . . . . . . . . . 27
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Service life of the handle . . . . . . . . . . . . . . . . . 31
Overview of reprocessing procedures . . . . . . . 32
Assembling the parts . . . . . . . . . . . . . . . . . . . . 36
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Definition of service terminology . . . . . . . . . . . 37
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Preventive maintenance . . . . . . . . . . . . . . . . . 41
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Adjusting the arm system . . . . . . . . . . . . . . . . 44
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Disposing of the medical device . . . . . . . . . . . 46
Disposal of accessories. . . . . . . . . . . . . . . . . . 46
Acceptance and handover . . . . . . . . . . . . . . 47
Technical data . . . . . . . . . . . . . . . . . . . . . . . . 48
Polaris Multimedia. . . . . . . . . . . . . . . . . . . . . . 48
List of accessories . . . . . . . . . . . . . . . . . . . . 50

Instructions for use Polaris Multimedia 7
Safety-related information
Safety-related information
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
Strictly follow the instructions for use of
other Dräger devices
Strictly follow the assembly instructions
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 "Intended use".
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 device malfunction
To properly use the video system, read and
comply with the instructions for use of the re-
spective display.
WARNING
Risk of damage to the device
The display mount may only be installed by
assembly personnel. The installation must be
carried out in accordance with the assembly
instructions.

Safety-related information
8 Instructions for use Polaris Multimedia
Service
Accessories
Not for use in areas of explosion hazard
Connected devices
Safe connection with other electrical
equipment
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 spe-
cialized service personnel.
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. Dräger
further recommends that only authentic
Dräger repair parts are used for maintenance.
WARNING
Risk due to incompatible accessories
Dräger has only tested the compatibility of ac-
cessories listed in the current list of accesso-
ries. Using other, incompatible accessories
may endanger patients due to malfunction of
the medical device.
Dräger recommends that the medical device is
only used together with accessories listed in
the current list of accessories.
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur.
WARNING
Risk of electric shock and device malfunction
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 an electric shock.
Before operating the medical device, strictly
comply with the instructions for use of all con-
nected devices or device combinations.
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these instructions for use or these assembly in-
structions must only be made when approved by
each respective manufacturer.

Instructions for use Polaris Multimedia 9
Safety-related information
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from third-
party manufacturers. Follow the accompanying
documents of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional integrity of the
individual devices may 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:
– IEC 60601-1 (2nd Edition)
Medical electrical equipment
Part 1: General requirements for basic safety
– IEC 60601-1-1
Medical electrical equipment
Part 1-1: General requirements for basic safety
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for basic safety
and essential performance
Collateral standard: Electromagnetic
compatibility - requirements and tests
– IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for basic safety
Collateral Standard: Programmable electrical
medical systems
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for basic safety
and essential performance
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Patient safety
The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to persons familiar with the most
important inherent characteristics of the medical
device.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
The instructions for use do not contain any
information 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
different underlying diseases
Medical device modification or misuse can be
dangerous.

Safety-related information
10 Instructions for use Polaris Multimedia
Installing accessories
Strictly observe instructions for use and assembly
instructions.
Storing the instructions for use
Training
Training for users is available via the Dräger
organization responsible (see www.draeger.com).
Functional safety
Essential performance means:
– the mounting of up to 2 displays.
Obligation to report incidents
Serious incidents involving this medical device
must be reported to Dräger and the competent
authorities.
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.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.