Polaris 7XX and 5XX Instructions for Use Edition 5 Jan 2013

Page 1

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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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

Page 8

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

Page 9

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

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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

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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

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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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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

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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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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

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Instructions for Use Polaris 7XX/5XX

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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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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

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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

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Instructions for Use Polaris 7XX/5XX

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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

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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)

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Instructions for Use Polaris 7XX/5XX

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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

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