Wolf CCD Endocam 3 User manual

Instruction Manual

3 CCD HDTV ENDOCAM

GA--A 253 /en/ Index: 08--09--2.0 / ÄM: PDG 09--3778

5550101

Important general instructions for use

Ensure that this product is usedonly as intended and described in this instruction manual, by ade­quately trained and qualified personnel, and that maintenance and repair is only carried out by
authorized specialized technicians.

Use this product only with the combinations and with the accessories and spare parts listed in
this instruction manual. Use other combinations, accessories and replacement parts only if they
are expressly intended for this use and if the performance and safety requirements are met.

Reprocess the products before every application and before returning them for repair as required
by the instruction manual in order to protect the patient, user or third parties.

Subject to technical changes!

Due to continuous development of our products, illustrations and technical data may deviate
slightly from the data in this manual.

CAUTION -- USA only:
Federal law restricts this device to sale by or on the order of a physician.

Safety instructions and levels of danger

Symbol Level of danger

WARNING!

Failure to observe can result in death or serious injury.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

.
.

IMPORTANT!

Failure to observe can result in damage to the product or surrounding.

NOTE!

Tips for optimum use and other useful information.

GERMANY
RICHARD WOLF GmbH
75438 Knittlingen
Pforzheimerstr. 32
Telephone: [phone]
Telefax: [phone]
MANUFACTURER

[e-mail]
www.richard--wolf.com

BELGIUM / NETHERLANDS

N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
9031 Gent Drongen
Telephone: [phone]
Telefax: [phone]

[e-mail]
www.richard--wolf.be

Marketing Office
U.A.E

RICHARD WOLF Middle East
P.O. Box 500283
AL Thuraya Tower 1

th

Floor,

9
Room 904, Dubai
Telephone: + 9 71 43 68 19 20
Telefax: + 9 71 43 68 61 12

[e-mail]
www.richard--wolf.com

USA

RICHARD WOLF
Medical Instruments Corp.
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Telefax: [phone]

sales&[e-mail]
www.richardwolfusa.com

FRANCE

RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
51100 Reims
Telephone: [phone]
Telefax: [phone]

[e-mail]

INDIA

RICHARD WOLF India Private Ltd.
JMD Pacific Square
No. 211 A, Second Floor
Behind 32
Gurgaon -- 122 001
National Capitol Region
Telephone: + 91 12 44 31 57 00
Telefax: [phone]

[e-mail]
www.richard--wolf.com

nd

Milestone

UK

RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW17 0HB
Telephone: + 44 20 89 44 74 47
Telefax: [phone]

[e-mail]
www.richardwolf.uk.com

AUSTRIA

RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
1160 Vienna
Telephone: [phone]
Telefax: [phone]

[e-mail]
www.richard--wolf.at

0

GA--A 253

Contents

1 General information 1.......................................................

1.1 Symbols 1..................................................................

1.2 Intended use 2..............................................................

1.2.1 Contraindications 2...........................................................

1.3 Combinations 3..............................................................

1.3.1 General requirements on products/components of a combination 3.................

1.3.2 Specific requirements on the products/components of a combination 4..............

1.4 Electromagnetic compatibility (EMC) 4..........................................

1.4.1 Video mode via DVI / HD--SDI connections 6....................................

2 Illustration 7................................................................

2.1 Front panel 7................................................................

2.1.1 Legend 7...................................................................

2.2 Rear panel 8................................................................

2.2.1 Legend 8...................................................................

3Set--up 9...................................................................

3.1 Preparation 9................................................................

3.1.1 Legend 10...................................................................

3.2 Color bar test image 10........................................................

3.3 Adjustment of LCD monitors 10.................................................

4 Checks 11...................................................................

4.1 Visual check 11...............................................................

4.2 Function check 1 1.............................................................

5Use 12......................................................................

5.1 Operating principle 12.........................................................

5.2 Controls and modes 12........................................................

5.3 Operation of device 13.........................................................

5.3.1 White balance 13.............................................................

5.3.2 Automatic brightness control 13.................................................

5.4 Menu control 14..............................................................

5.4.1 Overview of “OPTIONS MENU” 15..............................................

5.4.2 “PRESETS MENU” 16.........................................................

5.4.3 “BUTTON MENU” (camera button menu) 17......................................

5.4.4 Electronic zoom 17............................................................

5.4.5 Displaying and changing presets 18.............................................

5.4.6 Printer note 18................................................................

5.4.7 Recorder note 18.............................................................

5.4.8 Overview of “SETUP” 19.......................................................

6 Reprocessing and maintenance 20............................................

6.1 Reprocessing of device 20.....................................................

6.2 Maintenance 20...............................................................

6.2.1 Maintenance intervals 20.......................................................

7 Technical description 21.....................................................

7.1 Troubleshooting 21............................................................

7.2 Technical data 23.............................................................

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7.2.1 Interfaces 24.................................................................

7.3 Operating, storage, transport and shipping conditions 24...........................

7.4 Spare parts and accessories 24.................................................

7.5 Replacing parts 25............................................................

7.5.1 Device fuses 25...............................................................

7.5.2 Disposal of the product, packaging material and accessories 25.....................

II

GA--A 253

1 General information

1.1 Symbols

Symbols

μ

Meaning

Caution

Follow instructions for use

Power switch

Potential equalization

Fuse
Alternating current (AC)

TYPE BF APPLIED PART

Brightness

Automatic white balance (AWB)

”LEFT”

”RIGHT”

“UP” or ”PLUS”

“DOWN” or ”MINUS”

Preset

Display or change of preset menu

Display menu

Confirm input

Camera head connection

Do not place product in general waste bin. Recycle separately.

A Registered Trademark of ETL, a Recognized Testing Laboratory, confirm the compliance to the
standard of Medical Electrical Equipment CAN/CSA C 22.2 No. 601.1 (c) and UL 60601--1 (us)

Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product
and/or packaging is marked with this symbol. Products of category IIa and above, as well as
sterile products or products with measuring function of category I, are additionally marked with the
code number of the notified body (0124)

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1.2 Intended use

1.2.1 Contraindications

The 3 CCD HDTV ENDOCAM 5550 has been designed for the video
endoscopy and can be used for both diagnostic and therapeutic interven­tions

In conjunction with video storage devices and other video devices, it can be used
for recording and storing video images.

CAUTION!
Possible device failure.
In the case of therapeutic use, a second camera with similar
features should be available.

Contraindications directly related to the product are presently unknown.
On the basis of the patient’s general condition, the doctor in charge must
decide whether the planned application is possible or not. For further notes
and instructions, see the latest medical literature.

2

GA--A 253

1.3 Combinations

IMPORTANT!

.

In addition to this instruction manual follow the manuals of the products used in
combination with this product.

1.3.1 General requirements on products/components of a combination

The general requirements depend on whether the products/components are
inside or outside the patient environment.

Medically used room

Inside the patient environment

MP

μ

MP

μ

MP NMP

μ

MP

NMP

MP

μ

NMP

μ

**

Patient environment

Acc. to UL 60601 -- 1: R = 1.83 m (6 feet) ; h = 2.29 m (71/2feet)

outside the patient

environment

--

--

R=1.5m

Non-- medically

used room

--

--

Patient environment

h=2.5m

Requirements / measures

Leakage currents to clause 19

IEC/EN 60601--1--1

*

--

a) additional protective earth connection

(to be clarified with manufacturer),

or

b) with additional isolating transformer

**

μ

MP

μ

MP

μ

additional isolating transformer
according to IEC/ EN 60601--1--1 **

MP = medical electrical device according to IEC/ EN 60601--1, UL 60601--1, CSA C22.2 No. 601
NMP = non--medical electrical device in accordance with the relevant product--specific IEC/ EN/ UL/ IEC standards

* If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 μA

(300 μA for systems in acc.with UL 60601--1).

** e.g. Richard Wolf Video Trolley/cart with ”isolating transformer”.

NMP

μ

additional separating device
according to IEC/ EN 60601--1--1

--

MP or

NMP

μ

--

a) common protective earth connection, or
b) additional protective earth connection

(to be clarified with manufacturer), or

c) additional separating device (to avoid

earth/ground loops in the case of a
potential difference)

Functional
connection

μ power supply grid

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1.3.2 Specific requirements on the products/components of a combination

establishmentsandthosedirectlyconnectedtothepubliclow--voltage

IMPORTANT!

.

Persons combining products to form a system are responsible for not impairing the system’s compliance with
the performance and safety requirements, and that the technical data and the intended use are adequately
fulfilled.
Electromagnetic interference or other types of interference occurring between this product and other products
can cause failures or malfunctions.
When selecting the system components ensure that they meet the requirements for the medical environment
they are used in; in particular IEC/ EN 60601--1 --1. In case of doubt contact the manufacturer(s) of the system
components.
Do not touch connecting devices for electrical connections between the different components (such as signal
input and output connections for video signals, data exchange, control circuits, etc.) and the patient at the
same time.

1.4 Electromagnetic compatibility (EMC)

NOTE: The device or system in the following called product always relates to the 3 CCD HDTV ENDOCAM 5550

Guidance and manufacturer’s declaration -- electromagnetic emissions

The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.

Emissions measurement/test Compliance Electromagnetic environment -- Guidance

HF emissions to CISPR 11 Group 1

HF emissions to CISPR 11 Class B
Harmonic emissions to IEC 61000--3--2 Class A
In conformity with IEC 61000--3--3 “Voltage fluctuations / flicker

emissions”

The product uses HF energy for its internal function.
The HF emission level is extremely low and it is not likely to cause any
interference in nearby electronic equipment.

The product is suitable for use in all establishments, including domestic

--

power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration -- electromagnetic immunity

The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.

Immunity tests IEC 60601 test level Compliance Electromagnetic environment -- guidance

Electrostatic Discharge (ESD)
to IEC 61000--4--2

Electrical fast transients, bursts
to IEC 61000--4--4

Surge voltage (surges)
to IEC 61000--4--5

Voltage dips, short interruptions and
voltage variations on power supply
input lines
to IEC 61000--4--11

Power frequency (50/60 Hz) magnetic
field,
to IEC 61000--4--8

* NOTE: UTis the line/mains voltage prior to application of the test level.

± 6 KV contact
± 8KVair

± 2 KV for power supply lines
± 1 KV for input/output lines

± 1 KV differential mode
± 2KVcommonmode

Voltage dip for 0.5 cycle
> 95% U

Voltage dip for 5 cycles
> 60% UT*

Voltage dip for 25 cycles
> 30% UT*

Voltage dip for 5 sec
> 95% UT*

3A/m Yes

*

T

Yes

Yes

Yes

Yes

Floors should be wood, concrete or ceramic tile.
If the floors are covered with synthetic material, the
releative humidity should be at least 30%.

Mains/line power quality should be that of a typical
commercial or hospital environment.

Mains/line power quality should be that of a typical
commercial or hospital environment.

Mains/line power quality should be that of a typical
commercial or hospital environment. If the user of
the product requires continued operation during
power mains/line interruptions it is recommended
that the product be powered from an uninterruptible
power supply or battery.

Power frequency magnetic fields should be at
levels characteristic of a typical location in a
commercial or hospital environment.

4

GA--A 253

Guidance and manufacturer’s declaration -- electromagnetic immunity for products that are not life--supporting

The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.

Immunity test IEC 60601 test levels

Conducted HF interference
to IEC 61000--4--6

Radiated HF interference
to IEC 61000--4--3

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies.

These guidelines may not apply in all situations, as the propagation of electromagnetic waves is affected by absorption and
reflexion from buildings, objects and people.

1 = The field strength of fixed transmitters (e.g. base stations for radio telephones, land mobile radios, amateur radio, radio broadcast and

TV broadcast, ...), cannot be predicted theoretically with accuracy. To assess the EMC environment due to fixed transmitters an
electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds
the applicable compliance level above, the product should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product.

2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

3V

rms

150kHz to 80 MHz

3V/m
80 MHz to 2.5 GHz

Compliance

level

Yes

Electromagnetic environment -- guidance

Portable and mobile RF communications equipment should be
used no closer to any part of the product, including cables,
than the recommended separation distance calculated from
equation applicable to the frequency of the transmitter.

Recommended separation distance:

d=1.2p P
d=1.2p P for 80 MHz to 800 MHz
d=2.3p P for 800 MHz to 2.5 GHz

P = Nominal power output rating of the transmitter in watts (W)

(according to the transmitter manufacturer)

d = recommended separation distance in meters (m)
Field strengths from fixed RF transmitters, as determined by

an electromagnetic site survey1, should be less than the
compliance level in each frequency range2.

Interference may occur in the vicinity of devices with the
following symbol:

The recommended separation distances between portable and mobile HF telecommunication devices and
devices which are not life--supporting

The product is intended for use in an electromagnetic environment where HF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
HF telecommunications equipment and the product.

Rated nominal output power of the

transmitter (Watts)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can
be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W).

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflexion
from buildings, objects and people.

150 kHz to 80 MHz

Separation distance as a function of transmitter frequency (m)

d=1.2p P

80 MHz to 800 MHz

d=1.2p P

800 MHz to 2.5 GHz

d=2.3p P

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