polaris_7xx_and_5xx_instructions_for_use_edition_5_.pdf
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Instructions for Use
Polaris 7XX/5XX
WARNING
To properly use this medical device, the
user must obtain a full understanding of
the performance characteristics of this
medical device prior to use by carefully
reading these Instructions for Use.
Operating light/Video system
Page 2
Typographical Conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
z 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.
A Letters in illustrations denote elements referred
to in the text.
Trademarks
–
DrägerService®
–
Polaris™
are trademarks owned by Dräger.
2
Instructions for Use Polaris 7XX/5XX
Page 3
Safety Information Definitions
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 difficulties when operating the device.
Abbreviations and Symbols
For explanations, refer to sections "Abbreviations"
and "Symbols" in the "Overview" chapter.
Instructions for Use Polaris 7XX/5XX
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Instructions for Use Polaris 7XX/5XX
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Table of Contents
Table of Contents
For Your Safety and that of Your Patients . .
7
General Safety Information. . . . . . . . . . . . . . . . 7
Product-specific safety information. . . . . . . . . . 10
Safety information for reprocessing. . . . . . . . . 69
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 70
Reprocessing procedure . . . . . . . . . . . . . . . . . 72
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Troubleshooting . . . . . . . . . . . . . . . . . . . . . .
77
Intended use Polaris 7XX/5XX . . . . . . . . . . . . .
Intended use Polaris camera SD . . . . . . . . . . .
Intended use Polaris camera HD . . . . . . . . . . .
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fault – Cause – Remedy. . . . . . . . . . . . . . . . .
77
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . .
79
Polaris 7XX/5XX . . . . . . . . . . . . . . . . . . . . . . .
Polaris camera SD/HD . . . . . . . . . . . . . . . . . .
Adjusting the arm system . . . . . . . . . . . . . . . .
79
80
81
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
85
Disposal of the medical device . . . . . . . . . . . .
85
Acceptance and Handover . . . . . . . . . . . . . .
87
13
14
15
16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Compatibility of the Polaris camera SD/HD
components . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Assembly and Preparation . . . . . . . . . . . . . . 27
Polaris 7XX/5XX . . . . . . . . . . . . . . . . . . . . . . . .
Checking the Polaris camera SD/HD
(optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mounting the Polaris camera SD
(optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mounting the Polaris camera HD
(optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Video control unit connections . . . . . . . . . . . . .
Mounting the video control unit (optional). . . . .
Flatscreen. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
27
29
Polaris 7XX/5XX/Polaris camera SD/HD. . . . . 87
Camera SD/HD remote control . . . . . . . . . . . . 87
30
Technical Data . . . . . . . . . . . . . . . . . . . . . . . .
35
40
42
45
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 89
Ambient conditions . . . . . . . . . . . . . . . . . . . . . 93
Polaris 7XX/5XX . . . . . . . . . . . . . . . . . . . . . . . 94
Polaris camera SD . . . . . . . . . . . . . . . . . . . . . 98
Polaris camera HD . . . . . . . . . . . . . . . . . . . . . 99
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Positioning the Polaris 7XX/5XX . . . . . . . . . . .
Positioning the light system . . . . . . . . . . . . . . .
Positioning Polaris 7XX/5XX
with camera SD/HD . . . . . . . . . . . . . . . . . . . . .
Switching the Polaris 7XX/5XX
OR light mode on and off . . . . . . . . . . . . . . . . .
Adjusting the illumination intensity of the
Polaris 7XX/5XX . . . . . . . . . . . . . . . . . . . . . . . .
Switching the Polaris 7XX/5XX
ambient light mode on and off . . . . . . . . . . . . .
Adjusting the light field diameter. . . . . . . . . . . .
Operating the Polaris camera SD. . . . . . . . . . .
Operating the Polaris camera HD. . . . . . . . . . .
Camera SD/HD remote control. . . . . . . . . . . . .
47
48
52
89
List of Accessories . . . . . . . . . . . . . . . . . . . . 101
Polaris 7XX/5XX . . . . . . . . . . . . . . . . . . . . . . . 101
Polaris camera SD . . . . . . . . . . . . . . . . . . . . . 101
Polaris camera HD . . . . . . . . . . . . . . . . . . . . . 101
53
55
56
58
59
63
67
Cleaning, Disinfection and Sterilization . . . . 69
Instructions for Use Polaris 7XX/5XX
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Instructions for Use Polaris 7XX/5XX
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For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
General Safety Information
The following WARNING and CAUTION
statements apply to the general operation of the
medical device.
WARNINGS and CAUTIONS specific to subsystems or particular features appear with those
topics in later sections of these Instructions for Use
or in the Instructions for Use of any product being
used with this device.
Strictly follow these Instructions for Use
WARNING
Any use of the medical device requires full
understanding and strict observation of all
sections of these Instructions for Use. The
medical device may 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
labels.
Failure to observe these safety information
statements constitutes a use of the medical
device that is inconsistent with its intended
use.
Instructions for Use Polaris 7XX/5XX
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by trained personnel.
Repair and complex maintenance works on
the medical device have to be carried out by
experts.
Dräger recommends the DrägerService for
concluding a service contract as well as for
repairs. Dräger recommends using original
Dräger parts for repairs.
If the above are not complied with, the correct
functioning of the medical device may be
compromised.
Observe chapter "Maintenance".
Safety inspections
The medical device must be subject to regular
safety inspections. See chapter "Maintenance".
7
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For Your Safety and that of Your Patients
Accessories
WARNING
Only accessories indicated on the list of
accessories have been tested and approved
to be used with the medical device.
Therefore, it is strongly recommended that
only these accessories are used in
conjunction with the medical device.
Otherwise, the correct functioning of the
medical device may be compromised.
Connected devices
WARNING
Risk of electric shock and of device
malfunction.
Any connected devices or device
combinations not complying with the
requirements mentioned in these Instructions
for Use may compromise the correct
functioning of the medical device. Before
operating any combination of devices, refer to
and strictly comply with the Instructions for
Use for all connected devices and device
combinations.
Not for use in areas of explosion hazard
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
The medical device is neither approved nor
certified for use in areas where combustible
gas mixtures of anesthetic agent and air,
oxygen or N2O (laughing gas) are present.
Safe connection with other electrical equipment
OR servers have to be classified according to
software class B (following IEC 62304).
WARNING
OR servers may damage the light system.
If the OR servers do not comply with
IEC 60601-1 for use in the patient
environment, patients may be in danger when
the light system fails.
Ensure that the OR servers comply with
IEC 60601-1 for use in the patient
environment.
WARNING
Danger of personal injury
The flatscreens used must be classified
according to IEC 60601-1 for use within the
patient environment.
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these Instructions for Use or these Assembly
Instructions must only be made when approved
by each respective manufacturer.
Patient safety
The design of the medical device, the
accompanying literature, and the labeling on the
medical device take into consideration that the
purchase and use of the medical device are
restricted to trained professionals, and that certain
inherent characteristics of the medical device are
known to the trained operator.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device. These
Instructions for Use do not contain references to
various hazards which are obvious to a medical
professional who operates this medical device as
well as references to the consequences of medical
device misuse and to potentially adverse effects in
patients with different underlying diseases.
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Instructions for Use Polaris 7XX/5XX
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For Your Safety and that of Your Patients
Medical device modification or misuse can be
dangerous.
Functional safety
The essential performance characteristics of this
medical device are illumination of the operating
field and reduction of heat radiation to the operating
field.
Information on Electromagnetic Compatibility
WARNING
General information on electromagnetic
compatibility (EMC) according to international
EMC standard IEC 60601-1-2:
Medical electrical equipment is subject to
special precautionary measures concerning
electromagnetic compatibility (EMC) and must
be installed and put into operation in
accordance with the EMC information
provided on page 89.
Portable and mobile RF communications
equipment can affect medical electrical
equipment.
Installing accessories
CAUTION
Install accessories to the basic device in
accordance with the Instructions for Use of the
basic device. Make sure that there is a safe
connection to the basic device system.
Strictly observe Assembly Instructions and
Instructions for Use.
Training
Training for medical professionals is available from
the Dräger organization responsible, see
www.draeger.com.
Instructions for Use Polaris 7XX/5XX
9
Page 10
For Your Safety and that of Your Patients
Product-specific safety information
Do not use non-sterile handles
Improper applications
WARNING
Risk of infection for patients.
Do not use non-sterile handles on the lights.
Do not use disposable sleeves
WARNING
Risk of infection if disposable sleeves are
dropped!
Dräger recommends not using disposable
sleeves for the lights.
Do not use non-sterile handles on the lights.
Maximum heat intensity within the light fields
WARNING
Danger of personal injury.
W/m2
Heat radiation may exceed 1000
if the
light fields of two or more lights are focused
on one spot.
Using extreme caution when working with the
light system
WARNING
Danger of personal injury and/or equipment
damage.
Avoid collision of the light heads or parts of
the arm system.
These objects can fall down into the operation
field.
10
WARNING
Danger of personal injury and/or equipment
damage.
Do not hang any objects on the light head or
on the arm system. These objects can fall
down into the operation field.
Do not hang heavy loads on the arm system
(e.g., hanging body weight). Damage may
result to the mechanism of the arm system so
that correct positioning of the swivel arm may
be compromised.
Risk of an electric shock
WARNING
Risk of an electric shock.
When installing the light, the operator must
ensure that the disconnection of all poles is
guaranteed for maintenance and service. The
necessary switching element is not included
in the delivery of Dräger light systems.
WARNING
Risk of an electric shock.
Do not simultaneously touch the sterilizable
handle of the camera SD or camera HD and the
patient.
WARNING
Risk of an electric shock.
Do not touch the video control unit and the
patient at the same time.
Instructions for Use Polaris 7XX/5XX
Page 11
For Your Safety and that of Your Patients
Danger of excessive light radiation
WARNING
Danger of personal injury.
Do not position the light such that the light
field is directed towards the unprotected eye
of the patient.
Pay attention to the end stops
CAUTION
Danger of personal injury and/or equipment
damage.
When positioning the lights, do not use force to
pull the arm system beyond the end stops.
Risk of overheating the light head
CAUTION
Risk of equipment damage caused by
overheating.
Do not cover parts or the entire light head while
using it.
Direct visibility of the operation field
WARNING
The Polaris camera SD/HD is not intended to
be used as the sole visualization medium
during the operation. It must be ensured that
the OR personnel have a direct view of the
operation field at all times.
Instructions for Use Polaris 7XX/5XX
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Instructions for Use Polaris 7XX/5XX
Page 13
Application
Application
Intended use Polaris 7XX/5XX
The Polaris product line
Double or triple light combination
Polaris lights are classified as operating lights in
accordance with IEC 60601-2-41 and are intended
to be used for the local illumination of the surgery
and treatment area on the patient in operating and
treatment rooms.
Combining large operating lights as an operating
light system enables their use in operating and
treatment rooms.
Versions
–
Polaris 700 light
–
Polaris 750 light (prepared for integrating the
Polaris camera SD)
–
Polaris 760 light (prepared for integrating the
Polaris camera HD)
–
Polaris 500 light
–
Polaris 550 light (prepared for integrating the
Polaris camera SD)
–
Polaris 560 light (prepared for integrating the
Polaris camera HD)
–
Polaris camera SD
–
Polaris camera HD
Single light
As a single light, the Polaris light is intended to be
used as an operating or examination light in
operating or treatment rooms for diagnosis and
treatment purposes which can be interrupted
without posing a hazard to the patient in case the
light fails to work.
If used as a single light, the Polaris light is classified
as "small operating light" in accordance with
IEC 60601-2-41.
The Polaris 700/750/760 light and
Polaris 500/550/560 light differ with regard to the
size of the light head diameter and illumination
intensity:
Polaris 700/750/760
Light head diameter
785 mm
Illumination intensity
Approx. 160000 lux
Polaris 500/550/560
Instructions for Use Polaris 7XX/5XX
Light head diameter
630 mm
Illumination intensity
Approx. 110000 lux
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Application
Intended use Polaris camera SD
For recording the operation procedure in the
OR field for patient documentation purposes in
teaching and training.
For use as a video system in conjunction with a
medically approved flatscreen on the Polaris arm
system.
The recordings may only be used for non-diagnostic
evaluations.
The Polaris camera SD may only be used in
conjunction with the Polaris light.
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Instructions for Use Polaris 7XX/5XX
Page 15
Application
Intended use Polaris camera HD
For recording the operation procedure in the
OR field for patient documentation purposes in
teaching and training.
For use as a video system in conjunction with a
medically approved flatscreen on the Dräger arm
system.
The Polaris camera HD may only be used in
conjunction with the Polaris light.
The recordings may only be used for
non-diagnostic evaluations.
A Polaris camera HD system consists of:
–
Polaris camera HD which creates images with a
resolution of 1920 x 1080 pixels
–
Video control unit to control the
Polaris camera HD.
Instructions for Use Polaris 7XX/5XX
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Page 16
Application
Description
Polaris 7XX/5XX
Polaris camera SD
The Polaris light is designed for use in demanding
applications and is certified and approved to be
used as an operating light.
The Polaris camera SD is used for recording the
operation procedure in the operation field for
documentation purposes in teaching and training. It
must not be used for diagnostic purposes.
Modern LED bulbs are used in the Polaris light.
This ensures low energy consumption and a long
service life of the bulb. The small size of the LEDs
made it possible to use a modern design which
facilitates handling and cleaning while also
maintaining good flow behavior under laminar flow
ceilings.
The Polaris 700/750/760 light combines the
illumination intensity of 108 white LEDs and the
Polaris 500/550/560 light the illumination intensity
of 60 white LEDs to form a homogeneous
illumination volume of considerable illumination
depth and low shadiness. A color temperature
similar to natural light, good color reproduction, and
dimmable illumination intensity with a focusable
light field diameter ensure working conditions for
demanding surgical and treatment procedures.
–
The Polaris light is available with the
Polaris camera SD option for the visualization
of the surgical procedure and treatment area.
–
The Polaris light is available with a medically
approved flatscreen option for the displaying of
the images taken with the Polaris camera SD.
–
The Polaris light is available with the
Polaris camera HD option for the visualization
of the surgical procedure and treatment area.
–
The Polaris light is available with a medically
approved flatscreen option for the displaying of
the images taken with the Polaris camera HD.
16
–
Standard version: Connection to a flatscreen
with S-video input (Y/C).
–
Available with a medically approved flatscreen
option: The flatscreen is used to display the
images recorded with the Polaris camera SD.
Polaris camera HD
The Polaris camera HD is used for recording the
operation procedure in the operation field for
documentation purposes in teaching and training. It
must not be used for diagnostic purposes.
–
Standard version: Connection to a flatscreen
with HD-SDI input.
–
Available with a medically approved flatscreen
option: The flatscreen is used to display the
images recorded with the Polaris camera HD.
Instructions for Use Polaris 7XX/5XX
Page 17
Overview
Overview
Polaris 700/550 light system with Polaris camera SD (example of use)
A
C
E
D
B
E
D
F
F
K
K
I
H
G
I
M
L
J
N
O
J
Q
R
001
P
A Ceiling cover
K Circular handle
B IR receiver for camera SD remote control
L Polaris camera SD
C Ceiling tube
M Camera replacement handle
D Swivel arm/central axis
N Adapter ring
E Spring arm
O Sterilizable handle for Polaris camera SD
F Cardan mounting
P Sterilizable focus adjustment ring
G Polaris 700 light head
Q Wall-mounted control for Polaris 700/550 and
Polaris camera SD
H Polaris 550 light head
I
Light control panel
J
Sterilizable handle
Instructions for Use Polaris 7XX/5XX
R Camera SD remote control
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Page 18
Overview
Polaris 700/560 light system with Polaris camera HD (example of use)
A
D
E
C
D
J
U
T
U
D
E
J
B
E
F
F
K
K
I
H
G
I
M
L
J
N
O
J
Q
P
R
002
S
A Ceiling cover
M Camera replacement handle
B IR receiver for camera HD remote control
N Adapter ring
C Ceiling tube
O Sterilizable handle for Polaris camera HD
D Swivel arm/central axis
P Sterilizable focus adjustment ring
E Spring arm
Q Wall-mounted control for Polaris 700/560
F Cardan mounting
R Camera HD remote control
G Polaris 700 light head
S Video control unit
H Polaris 560 light head
T Double flatscreen mount
I
Light control panel
U Flatscreen
J
Sterilizable handle
K Circular handle
L Polaris camera HD
18
Instructions for Use Polaris 7XX/5XX
Page 19
Overview
Polaris 700 light head
Polaris 550 light head with
Polaris camera SD (optional)
A
C
A
C
B
G
D
E
E
B
D
F
G
004
003
F
A Cardan mounting
B Light control panel
A Cardan mounting
C Circular handle
B Light control panel
D Bottom glass
C Circular handle
E Sterilizable handle
D Bottom glass
F Reflector
E Polaris camera SD
G LEDs (light-emitting diodes)
F Sterilizable handle for Polaris camera SD
G Sterilizable focus adjustment ring
Instructions for Use Polaris 7XX/5XX
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Page 20
Overview
Polaris 560 light head with
Polaris camera HD (optional)
A
C
E
B
D
F
004
G
A Cardan mounting
B Light control panel
C Circular handle
D Bottom glass
E Polaris camera HD
F Sterilizable handle for Polaris camera HD
G Sterilizable focus adjustment ring
20
Instructions for Use Polaris 7XX/5XX
Page 21
Overview
Compatibility of the Polaris camera SD/HD components
Camera components
Order no.
Polaris 550/750 Polaris 560/760 Polaris 500/700
Polaris camera HD
G24610
–
Upgradable
–
Set of sterilizable handles
for Polaris camera HD (2 units)
G24613
–
X
–
Polaris replacement handle
camera HD
G25098
–
X
–
Polaris camera SD (PAL)
G25052
Upgradable
–
–
Polaris camera SD (NTSC)
G25053
Upgradable
–
–
Set of sterilizable handles for
Polaris camera SD (2 units)
G24614
X
–
–
Polaris replacement handle
camera SD
G25097
X
–
–
Video HD remote control
G24002
–
Optional
–
Video SD remote control
G24003
Instead of the
wall-mounted
control with +CA
–
–
Interface set remote control
G24000
For connecting
the remote
control SD
For connecting
the remote
control HD
–
IR receiver kit
G95303
For connecting
the remote
control SD
For connecting
the remote
control HD
–
–
Must be available
for the operation
of the Polaris
camera HD
–
Video controller HD (video control G24611
unit)
X means: compatible
– means: not compatible
Instructions for Use Polaris 7XX/5XX
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Page 22
Overview
Camera components
LED wall-mounted control L1
Order no.
Polaris 550/750 Polaris 560/760 Polaris 500/700
–
Optional
Optional
LED wall-mounted control L1+CA G24253
Instead of SD
remote control
–
–
LED wall-mounted control L2
G24254
Optionally with
SD remote
control
Optional
Optional
LED wall-mounted control L2+CA G24255
Instead of SD
remote control
–
–
LED wall-mounted control L3
G24256
Optionally with
SD remote
control
Optional
Optional
LED wall-mounted control L3+CA G24257
Instead of SD
remote control
–
–
Optional
Optional
Optional
Integrated OR interface
G24252
G23840
X means: compatible
– means: not compatible
22
Instructions for Use Polaris 7XX/5XX
Page 23
Overview
Camera remote control SD
A
M
B
N
D
E
F
G
H
M Battery/rechargeable battery compartment
I
J
N Rating plate
K
L
008
M
009
C
A IR transmitter
B Status LED
C Zoom, magnify image
D Zoom, minimize image
E Manual focus, focus on nearby object
F Manual focus, focus on distant object
G Switch autofocus on/off
H Switch one-touch autofocus on/off
I
Iris diaphragm/exposure, magnify iris
J
Iris diaphragm/exposure, minimize iris
K Freeze frame
L Standby key
Instructions for Use Polaris 7XX/5XX
23
Page 24
Overview
Video control unit
D
C
E
F
H
G
J
I
K
N
L
M
005
A
B
A On/off switch
B Image rotation, counter-clockwise
C Image rotation, clockwise
D Zoom, magnify image
E Zoom, minimize image
F Switch one-touch autofocus on/off (key with
status LED)
G Manual focus, focus on distant object
H Manual focus, focus on nearby object
I
Switch autofocus function on/off (key with
status LED)
J
Iris diaphragm/exposure, magnify iris
K Iris diaphragm/exposure, minimize iris
L Switch autoiris function on/off (key with status
LED)
M White balance
N Freeze frame (key with status LED)
24
Instructions for Use Polaris 7XX/5XX
Page 25
Overview
Camera remote control HD
A
P
E
B
D
F
G
H
I
J
P Battery/rechargeable battery compartment
K
L
Q Rating plate
Q
007
C
M
N
P
006
O
A IR transmitter
B Status LED
C Image rotation, counter-clockwise
D Image rotation, clockwise
E Zoom, magnify image
F Zoom, minimize image
G Manual focus, focus on nearby object
H Manual focus, focus on distant object
I
Switch autofocus on/off
J
Switch one-touch autofocus on/off
K Iris diaphragm/exposure, magnify iris
L Iris diaphragm/exposure, minimize iris
M Switch autoiris function on/off
N Freeze frame
O Standby key
Instructions for Use Polaris 7XX/5XX
25