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
This page has been left blank intentionally.

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.

Instructions for use Polaris 600 11
Safety-related information
Radio-frequency interference
Installing accessories
Strictly observe the 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
The essential performance of lights consists in:
– illumination of the operating field,
– reduction of thermal radiation into the operating
field.
Obligation to report incidents
Serious incidents involving this medical device
must be reported to Dräger and the competent
authorities.
WARNING
Risk of device malfunction
The light system can cause radio-frequency
interference.
Shielding of components or reorientation of
the light system may be necessary.
CAUTION
Risk of device failure
Install the accessory on the basic device in
accordance with the instructions of the basic
device.
Check for secure connection to the basic device.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to
the user.

Safety-related information
12 Instructions for use Polaris 600
Product-specific safety information
Do not use non-sterile handles
Use of disposable sleeves
Thermal radiation from the lights
Exercise caution when working with the
system
Incorrect use
Risk of electric shock
WARNING
Risk of infection
Personnel and patient may become infected
by a non-sterile handle.
Use only sterile handles.
WARNING
Risk of infection
Disposable sleeves can fall down into the
operating field.
Dräger recommends using disposable
sleeves from another manufacturer (e.g.,
Covidien) only with the corresponding handle
adapter for disposable sleeves from the same
manufacturer, see list of accessories.
WARNING
Risk of patient injury
If the light fields from several lights overlap,
the heat input to the wound site may be
unacceptably high. This can lead to drying
out of the wound site.
If necessary, the total irradiance must be
adjusted by reducing the illuminance of
individual lights, see "Setting the
illuminance" on page 42.
WARNING
Risk of personal injury and property damage
Objects can fall down into the operating field.
Avoid collisions of the light heads or of parts
of the arm system with other objects.
WARNING
Risk of personal injury and property damage
Do not place objects on the light heads or
hang them on the arm system. These objects
can fall down into the operating field.
Do not hang heavy loads on the arm system
(e.g., leaning body weight). The mechanism
of the arm system may be damaged, which
may compromise the correct positioning of
the arm system.
WARNING
Risk of electric shock
Persons may receive an electric shock if all
poles are not disconnected during
maintenance work.
Make sure that a switching element to
disconnect all poles of the supply is fitted
before installing the light. The required
switching element is part of the Dräger mains
connection component.

Instructions for use Polaris 600 13
Safety-related information
Direct view of the operating field
Cautious positioning of the arm system
Risk of the light head overheating
Compatibility of displays
Observe the maximum load of the
display mount
Read and observe the instructions for
use of the displays
OR server
WARNING
Risk of personal injury
A camera is not intended to be used as the
sole visualization medium during an
operation.
Make sure that the OR personnel have a
direct view of the operating field at all times.
CAUTION
Risk of personal injury and property damage
The stops on the arm system may become
damaged.
When positioning the swivel arms and the
attached devices, take care not to use force to
pull the arm system beyond the stops.
WARNING
Risk of property damage
The light head may overheat during
operation.
Do not cover the light head completely or
partially.
WARNING
Risk due to incompatible displays
The displays used in combination with a
Polaris light system must be approved for
use in the patient environment according to
IEC 60601-1.
WARNING
Risk of personal injury and property damage
The specification for the maximum load on
the display mount must not be exceeded.
Comply with the maximum load of the
display mount.
WARNING
Risk of device malfunction
To properly use the light system, read and
comply with the instructions for use of the
respective display.
WARNING
Risk of patient injury
The OR servers used must conform to Safety
Class B of the IEC 62304 standard.
WARNING
Risk of patient injury
The OR severs used must conform to the
IEC 60601-1:1988 (or later) or IEC 60950-1
standards.

Safety-related information
14 Instructions for use Polaris 600
Emission of high-frequency energy
This medical device is optionally equipped with a
radio transmitter.
This medical device has been designed and
manufactured to comply, amongst others, with
emission limit values for high-frequency energy.
These limit values are incorporated in international
safety standards such as IEC 60601-1-2 and in
radio equipment standards such as EN 301 893
which have been accepted by regulation
authorities.
The radio transmitter module of this device also
complies with Part 15 of the FCC Rules. Operation
is subject to the following two conditions:
1this device may not cause harmful interference,
and
2this device must accept any interference
received, including interference that may cause
undesired operation of the device.
Changes or modifications not expressly approved
by Dräger could void the user’s authority to
operate the equipment.
This medical device includes radio equipment in
compliance with Directive 2014/53/EU. The full
text of the EU declaration of conformity is available
at the following internet address:
www.draeger.com/doc-radio

Instructions for use Polaris 600 15
Application
Application
Intended use
Intended use of Polaris 600 light
Polaris product family
The Polaris 600 light system is classified as a
surgical light system in accordance with IEC
60601-2-41 and is intended to be used for the local
illumination of the operating field and examination
field on the patient in operating and treatment
rooms.
The intended uses remain unchanged when the
Polaris 600 light is combined with a Polaris 100 or
200 light.
Ceiling-mounted versions
Single light
As a single light, the Polaris 600 light is intended to
be used as a surgical or examination light in
operating and treatment rooms for diagnostic and
treatment purposes which can be interrupted
without posing a hazard to the patient if the light
fails.
As a single light, the Polaris 600 light is classified
as a "small surgical light" in accordance with
IEC60601-2-41.
Double or triple light combination
The combination of 2 or more Polaris 600 lights as
a surgical light system enables use in operating
and treatment rooms and meets the requirements
for a fail-safe surgical light system.
Intended use of the Dräger disposable handle
The Dräger disposable handle provides a sterile
cover for the associated inner handle of Polaris
systems. The Dräger disposable handle is
intended solely for single use.
Intended use of the MedView camera
The MedView camera is intended for recording the
operating field for the purpose of patient
documentation, teaching, and training.
In the Polaris 600 light system, the MedView
camera is used together with a medical display as
a video system. The MedView camera must only
be used in conjunction with the Polaris 600 light.
The recordings must only be used for non-
diagnostic purposes.

Application
16 Instructions for use Polaris 600
Environments of use
Polaris 600 lights are intended for use in rooms
used for medical purposes, especially operating
rooms and treatment rooms.
Description
Light
The Polaris 600 light is certified and approved as a
surgical light. The Polaris 600 light uses LED
bulbs. This ensures low energy consumption and a
long service life of the bulb. The small size of the
LED bulbs makes it possible to use a modern
design which facilitates ease of handling and
cleaning while also maintaining good flow behavior
under laminar flow ceilings.
OR light mode
The Polaris 600 light combines the illumination
from 92 white LED bulbs to create a homogeneous
light column with deep cavity illumination and
minimal shadowing. The adjustable color
temperature, good color reproduction, and
adjustable illuminance ensure optimum working
conditions for demanding procedures within the
operating field and the examination field. The
illuminance can be adjusted in the OR light mode.
Ambient light mode (Endo light)
In the ambient light mode, the surroundings can be
illuminated for minimally invasive procedures. In
this light mode, the illuminance is significantly
lower than in the OR light mode. The illuminance
cannot be adjusted in the ambient light mode.
Color temperature
The color temperature can be adjusted in 4 steps,
which the surgeon can select depending on tissue
structure, operating field, and individual
perception.
Cold white light increases concentration, while
warm white light reduces dazzle effects and
increases the contrast.

Instructions for use Polaris 600 17
Overview
Overview
Multimedia system with 2 Polaris 600 lights (configuration example)
ACeiling cover BIR receiver for Polaris 600 remote control for
MedView camera
26588
H
G
N
P
M
II
J
L
Q
Q
H
A
CF
E
E
R
O
O
K
J
D
B
S

Overview
18 Instructions for use Polaris 600
CCeiling tube
DCentral axis
ELight swivel arm
FDisplay swivel arm
GDisplay spring arm
HLight spring arm
IGimbal mounting
JLight control panel
KPolaris 600 light
LPolaris 600 light with MedView camera and
radio transmitter
MDisplay mount (24 inch to 32 inch) with radio
receiver
NDisplay
OSterilizable handle E
PSterilizable handle
QIntegrated handle
RWall-mounted control panel
SPolaris 600 remote control for MedView
camera

Instructions for use Polaris 600 19
Overview
Light system with a Polaris 600 and a Polaris 100 light (configuration
example)
ACeiling cover
BCeiling tube
CCentral axis
DLight swivel arm
ELight spring arm
FGimbal mounting
GLight control panel
HSterilizable handle
IPolaris 600 light
JPolaris 100 light
KIntegrated handle
LWall-mounted control panel
26890
A
B
C
D
D
E
E
F
F
J
H
G
K
K
G
L
I
H

Overview
20 Instructions for use Polaris 600
Polaris 600 light with sterilizable handle E
AGimbal mounting
BIntegrated handle
CLight control panel
DSterilizable handle E
ELens with LED
FBottom glass
Polaris 600 light with sterilizable handle E and MedView camera
AGimbal mounting
BIntegrated handle
CLight control panel
DSterilizable handle E
ELens with LED
FBottom glass
GMedView camera
26592
A
A
B
D
EF
C
26591
A
A
B
D
EF
G
C