Dräger Polaris 600 User manual

Instructions for use
Polaris 600
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Surgical light
Polaris 600

2 Instructions for use Polaris 600
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Instructions for use Polaris 600 3
Contents
Polaris 60 0
Contents
Information regarding the instructions for
use .................................................................. 5
Regional availability......................................... 5
Trademarks ..................................................... 5
Safety information definitions .......................... 6
Target group.................................................... 6
Abbreviations and symbols.............................. 7
Safety-related information ............................ 8
General safety information .............................. 8
Product-specific safety information.................. 12
Application ..................................................... 15
Intended use.................................................... 15
Environments of use........................................ 16
Description....................................................... 16
Overview......................................................... 17
Multimedia system with 2 Polaris 600 lights
(configuration example) ................................... 17
Light system with a Polaris 600 and a
Polaris 100 light (configuration example) ........ 19
Polaris 600 light with sterilizable handle E ...... 20
Polaris 600 light with sterilizable handle E and
MedView camera............................................. 20
Light control panel ........................................... 21
MedView camera (option)................................ 22
Wall-mounted control panel for 2 Polaris 600
lights and a MedView camera (configuration
example).......................................................... 23
OR panel (option) ............................................ 24
Polaris 600 control interface (option)............... 24
Abbreviations................................................... 24
Symbols........................................................... 25
Operating concept ......................................... 26
Operating controls and their functions on the
Polaris 600 light ............................................... 26
Operating controls and their functions on the
Polaris 600 and Polaris 100/200 light system.. 27
Sterilizable handle E........................................ 28
Wall-mounted control panel (option)................ 29
Color assignment of the lights to the wall-
mounted control panel ..................................... 30
Assembly and preparation............................ 31
Checking for operational readiness before
each use.......................................................... 31
Fitting the handle............................................. 32
Operation ........................................................ 35
Positioning a light ............................................ 35
Positioning a light system................................ 37
Positioning the MedView camera .................... 38
Status LEDs .................................................... 39
Switching the light on and off .......................... 40
Synchronization function ................................. 40
Setting the illuminance .................................... 42
Color temperature function.............................. 48
Light field diameter function ............................ 49
Ambient light mode (Endo light) ...................... 51
Operating the MedView camera using the wall-
mounted control panel ..................................... 52
Operating the MedView camera by means of
the Polaris 600 remote control for MedView
camera ............................................................ 57
Replacing the battery in the Polaris 600 remote
control for MedView camera............................ 58
Troubleshooting............................................. 60
Fault – Cause – Remedy................................. 60
Reprocessing ................................................. 66
Safety information ........................................... 66
Disassembly .................................................... 67
Service life of the handle ................................. 69
Overview of reprocessing procedures............. 70
Materials used in the light................................ 72
Assembling the parts....................................... 72
Maintenance ................................................... 73
Overview ......................................................... 73
Inspection ........................................................ 73
Preventive maintenance.................................. 76
Repair.............................................................. 76
Adjusting the arm system ................................ 77
Locking segment of the spring arm ................. 79
Acceptance and handover............................... 80

Contents
4 Instructions for use Polaris 600
Disposal.......................................................... 81
Disposing of the medical device ...................... 81
Disposing of non-rechargeable batteries......... 81
Disposal of accessories................................... 81
Technical data................................................ 82
EMC declaration.............................................. 82
Ambient conditions .......................................... 84
Technical light data ......................................... 84
Electrical data.................................................. 86
Mechanical data .............................................. 87
MedView camera............................................. 87
Polaris 600 remote control for MedView
camera ............................................................ 88
Wireless video transmission ............................ 88
Combination with system components............ 90
Operating options ............................................ 90
Classifications ................................................. 90
List of accessories ........................................ 92
List of accessories for Polaris light and
MedView camera............................................. 92
Index ............................................................... 93

Instructions for use Polaris 600 5
Information regarding the instructions for use
Information regarding the instructions for use
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
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet points indicate individual actions or dif-
ferent 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.
Trademark
Polaris®

Information regarding the instructions for use
6 Instructions for use Polaris 600
Safety information definitions
Target group
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.
Reprocessing personnel
This target group includes persons who are
responsible for the reprocessing of medical
devices.
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
information about a potentially hazardous
situation which, if not avoided, may result in
minor or moderate 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 its
intended use
Training in a relevant
healthcare field or in a
medical discipline and
knowledge of the use of the
product
Task Requirement
Reprocessing Specialist knowledge in the
reprocessing of medical
devices

Instructions for use Polaris 600 7
Information regarding the instructions for use
Service personnel Specialized service personnel
Dräger recommends arranging a service contract
with DrägerService.
Abbreviations and symbols
Explanations can be found in the sections
"Abbreviations" and "Symbols" in chapter
"Overview".
Task Requirement
Installation Specialist knowledge in
electrical engineering and
mechanics
Experience in the servicing
of medical devices
Basic service activi-
ties (inspection,
maintenance accord-
ing to the "Mainte-
nance" section)
Task Requirement
Installation Specialist knowledge in
electrical engineering and
mechanics
Experience in the servicing
of medical devices
Training in service activities
on this product
Basic and complex
service activities
(inspection, mainte-
nance, repair)

Safety-related information
8 Instructions for use Polaris 600
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
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the
purpose specified under "Intended use" (see
page 15). Strictly observe all WARNING and
CAUTION statements throughout these
instructions for use and all statements on
medical device labels.
Failure to observe these safety information
statements constitutes a use of the medical
device that is inconsistent with its intended
use.
WARNING
Risk of incorrect operation and of incorrect
use
For correct use of a Polaris 100 or 200 light in
combination with the Polaris 600 light, read
and observe the Polaris 100/200 instructions
for use.
WARNING
Risk of incorrect operation and of incorrect
use
For correct use of a display mount in
combination with a Polaris light, read and
observe the Polaris Multimedia instructions
for use.
WARNING
Risk of damage to the device
The light system must only be installed by
assembly personnel. The installation must be
carried out in accordance with the assembly
instructions.

Instructions for use Polaris 600 9
Safety-related information
Service
Accessories
Not for use in areas of explosion hazard
Connected devices
Safe coupling with electrical equipment
Device combinations
This device may be operated in combination with
other Dräger devices or with devices from third-
party manufacturers. Observe the accompanying
documents of the individual devices.
If a device combination is not approved by Dräger,
the safety and functional integrity of the individual
devices may be compromised. The operator must
ensure that the device combination conforms to
the applicable editions of the relevant standards
for medical devices.
Device combinations that are approved by Dräger
meet the requirements of the following standards:
– IEC 60601-1, 3rd edition (general safety
requirements, device combinations, software-
controlled functions)
– IEC 60601-1-2 (electromagnetic
compatibility)
WARNING
Risk if service is not performed regularly
If service is not performed regularly,
malfunctions may occur, which can result in
personal injury and property damage.
Perform the service in accordance with the
chapter "Maintenance".
WARNING
Risk due to incompatible accessories
The use of incompatible accessories may
adversely affect the functional integrity of the
product. Personal injury and property
damage may occur as a consequence.
Use only compatible accessories. The
accessories that are compatible with this
product are listed in the list of accessories
supplied with the product.
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 of device
malfunction
Any connected devices or device
combinations not complying with the
requirements in these instructions for use
may compromise the correct functioning of
the medical device.
Before using the medical device, refer to and
strictly comply with the instructions for use
of all connected devices and device
combinations.
CAUTION
Risk of patient injury
Coupling with electrical equipment that is not
mentioned in these instructions for use or
assembly instructions may only be done with the
respective device manufacturer.

Safety-related information
10 Instructions for use Polaris 600
Or:
– IEC 60601-1, 2nd edition (general safety
requirements)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-4 (software-controlled
functions)
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.
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 82).
This device can be affected by other electrical
devices.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against
electrostatic discharge are employed in the
following situations:
– When touching the pins of connectors
that carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the
following measures and train the relevant
personnel:
– Observe the ESD protective measures.
Such measures may include wearing
antistatic clothing and shoes, touching a
potential equalization pin before and while
making the connection, or using
electrically insulating and antistatic
gloves.
– Observe the requirements for the
electromagnetic environment. Observe
the following section: "Electromagnetic
environment" (page 82).
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.