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Instruction Manual

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3-Chip HD Camera Head


ENDOCAM Logic HD
8552592x

BB-A 282-03 / en /

2012-07 V1.0 / PDG 00-0000

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Important general notes and instructions for use


Make sure that this product is used only as intended and described in this instruction manual, by adequately
trained and qualified medical personnel, and that maintenance and repair are only carried out by authorized
experts.
Use the product only in the combinations and with the accessories and spare parts specified in this instruction
manual. Use other combinations, accessories and replacement parts only if they are expressly intended for
the planned application and if the performance characteristics and safety requirements are not impaired. Do
not alter the product in any way.
Reprocess the products before every application and before returning them for repairs as required by the
instruction manual in order to protect the patient, user and others.
Immediately upon receipt, check the product and its accessories for completeness and possible damage.
Should the shipment give right to complaints, please inform the manufacturer or supplier immediately.
Subject to technical changes!
Due to ongoing developments, the illustrations and technical data may deviate slightly.

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 surroundings.

NOTE !

for optimum use and other useful information.


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GERMANY
RICHARD WOLF GmbH
75438 Knittlingen
Pforzheimerstr. 32
Telephone: +49 70 43 35-0
Telefax:
+49 70 43 35-300
MANUFACTURER
info@richard-wolf.com
www.richard-wolf.com

BELGIUM / NETHERLANDS
N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
9031 Gent Drongen
Telephone: +32 92 80 81 00
Telefax:
+32 92 82 92 16
endoscopy@richard-wolf.be
www.richard-wolf.be
Marketing Office
U.A.E
RICHARD WOLF Middle East
P.O. Box 500283
AL Thuraya Tower 1
9th Floor,
Room 904, Dubai
Telephone: + 9 71 43 68 19 20
Telefax:
+ 9 71 43 68 61 12
middle.east@richard-wolf.com
www.richard-wolf.com

USA
RICHARD WOLF
Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Toll Free: 001 (800) 323 - 9653
Phone: 001 (847) 913 - 1113
Fax:
001 (847) 913 - 1488
sales@richardwolfusa.com
www.richardwolfusa.com
FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
F-51100 Reims
Telephone: +33 3 26 87 02 89
Telefax:
+33 3 26 87 60 33

UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW17 0HB
Telephone: + 44 20 89 44 74 47
Telefax:
+ 44 20 89 44 13 11
admin@richardwolf.uk.com
www.richardwolf.uk.com

france@richard-wolf.com

austria@richard-wolf.com
www.richard-wolf.com

AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstrae 93 a
A-1160 Vienna
Telephone: +43 14 05 51 51
Telefax:
+43 14 05 51 51 45

INDIA
RICHARD WOLF India Private Ltd.
JMD Pacific Square
No. 211 A, Second Floor
Behind 32nd Milestone
Gurgaon - 122 001
National Capitol Region
Telephone: + 91 12 44 31 57 00
Telefax:
+ 91 12 44 31 57 05
india@richard-wolf.com
www.richard-wolf.com

BB-A 282-03

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Contents
1
1.1
1.2
1.3
1.4
1.4.1
1.4.2
1.5

General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications and side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1
1
1
1
2
2
2
2

2
2.1

Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Camera head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3
3

3
3.1

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the objective lenses and endoscopes to the camera head . . . . . . . . . . . . .

4
4

4
4.1
4.2

Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Visual check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6
6
6

5
5.1

Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Function assignment of the camera head buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6
6

6
and maintenance
. . . . be
. . . .removed
. . . . . . . . . .with
. . . . .the
. . . .full
. . . version.
..............
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6.1 DEMO
Overview:
reprocessing
of camera
heads . . .(http://www.cadkas.com).
...................................
6.2
6.2.1
6.2.2
6.3
6.4
6.5

Reprocessing of camera heads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contaminated camera plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reprocessing procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low-temperature sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7
7
7
7
7
8
9
9

7
7.1
7.2
7.3

Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating, storage, transport and shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disposal of product, packaging material and accessories . . . . . . . . . . . . . . . . . . . . . . . .

10
10
11
11

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General information

1.1

Symbol
Symbol

Designation
Follow the instruction manual
Recycle the product separately. Do not discard together with other waste.
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 identified with the code no. of
the notified body (0124).

1.2

Intended use
In conjunction with the ENDOCAM Logic HD Controller 552510x camera
the 3-Chip HD ENDOCAM Logic HD 552592x Camera Head is used for
disgnostic and therapeutic interventions.

This product is designed exclusively for use by specialized medical per


sonnel and may only be applied by medically qualified and adequately
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1.3

Indications and field of application


This product is used for diagnostics and therapy in conjunction with endo
scopic accessories.
On the basis of the patients general condition, the user in charge must
decide whether the planned use is possible or not. For further notes and
instructions please refer to the latest medical literature.

CAUTION!
Possible failure of the camera head.
For therapeutic applications a second camera head with the same spe
cifications should be available.

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1.4

Contraindications and side effects

1.4.1

Contraindications
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 use is possible or not.
For further notes and instructions please refer to the latest medical litera
ture.

1.4.2

Side effects

1.5

Combinations

Side effects directly related to the product are currently unknown.

CAUTION!
For a joint use of the different products it is necessary that the intended
use and the relevant technical data such as working length, diameter etc.
are the same.
Follow the instruction manuals of the products used in conjunction with
this product.
When using the camera head, instruction manual GA-A282 for the EN
DOCAM Logic HD Controller 552510x camera must be followed.

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Illustration

2.1

Camera head

1.1 1.2

1.5

1.4

1.3

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1.7

1.6

Legend
1

Camera head

1.1

Head button 1 (bright


bright)
bright for remote control (for button configuration see GA-A 282)

1.2

Head button 2 (dark


dark)
dark for remote control (for button configuration see GA-A 282)

1.3

C-mount thread for objective lens

1.4

Serial no.

1.5

Product no.

1.6

Camera plug

1.7

Plug protection cap

Protection cap

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Preparation
WARNING!
The applied part is not protected against explosions.
Explosion hazard.
Do not operate the applied part in ignitable atmosphere.
IMPORTANT!
Never direct the camera head at the sun or bright light sources in the vi
cinity. High-energy radiation in the visible and ultrviolet wavelength
ranges can damage the CCD chip surface. This may result in color dis
tortions and image noise.
When the camera head is not used, the protection cap must be installed.
IMPORTANT!
Never pull at the camera cable.
Never squeeze, pinch and/or excessively bend the camera cable as this
may cause damage to the wiring resulting in image failure.

3.1

Connecting the objective lenses and endoscopes to the camera head

IMPORTANT!
If the image is to dark, grainy or if there is image noise, this may be due
to an excessively large focal length of the objective lens or a zoom lens
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Check the focal length of the objective lens or the adjustment of the zoom
objective lens.
NOTE!
Before assembling the endoscope and objective lens, check that the
glass surfaces of the endoscope, objective lens and camera head are dry
and dust-free. Any soiling can be removed with a cotton swab soaked
with allcohol (wooden or plastic swab carrier, not metal).
For a detailed description and overview of the objective lenses, see in
struction manual GA-S 022.
022

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Connecting the C-mount objective lens:


Remove the protection caps from the camera head and objective lens
(Fig.1).
Screw the C-mount objective lens onto the camera head by turning
clockwise (Fig. 2).
Connecting the endoscope:
Place the endoscope onto the objective lens:
The snap-on locking mechanism is open and spring-loaded (Fig. 3) Insert the endoscope (Fig. 4) - The snap-on locking mechanism locks
automatically holding the endoscope in place.
To remove the endoscope pull back the snap-on mechanism until it is
unlocked (Fig. 3).
Abb. 1

Abb. 3

Abb. 2

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Abb. 4

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Checks
IMPORTANT!
Run through the checks before and after each use.
Do not use the products if they are damaged or incomplete or have loose
parts.
Return damaged products together with any loose parts for repair.
Do not attempt to do any repairs yourself.

4.1

Visual check

Before and after each use, check the camera head and the accessor
ies for damage, sharp edges, loose or missing parts and rough sur
faces.
Check the connection cables and adapters for damage.
Any inscriptions, lettering or labeling necessary for the safe intended
use must be legible.
Missing inscriptions, lettering or labeling leading to wrong handling or
reprocessing must be reinstated.
Fogging or functional impairment may indicate the ingress of liquid.

4.2
Function check
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Carry outPDF-Editor
the function check
of the camera head together with the EN
DOCAM Logic HD Controller 552510x camera in accordance with
manual GA-A282.
GA-A282

Use
IMPORTANT!
The camera heads cannot be used for PPD and DAFE applications.

5.1

Function assignment of the camera head buttons


For the function configuration of the camera head buttons, see manual
GA-A282 for the ENDOCAM Logic HD Controller 552510x camera.

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Reprocessing and maintenance


IMPORTANT!
Follow the latest notes and instructions in manual GA-J 020, Reproces
instruments.
sing of RICHARD WOLF heat-stable instruments
Do not use disinfectants containing peracetic acid without corrosion
protection, phenols or chlorine components for the reprocessing of Ri
chard Wolf products.
Strictly adhere to the maximum immersion time in the disinfectants used,
as described by the manufacturers.

6.1

Overview: reprocessing of camera heads

Product no.
Camera head

Cleaning
Manual

Machine

Disinfection
Ultrasound

Manual

Machine

Sterilization
High Level

Steam

8552592x

Gas
FA,
V-PRO 1

STERIS
SYSTEM 1 ,
STERIS
SYSTEM 1E

STERRAD
STERRAD
50 / 100S / 200 / NX
100 NX ,
PLASMASTER
40 / 80 / 140

+ = recommended , - = must not be used!

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IMPORTANT!
Immerse and sterilize the camera plug only with the plug protection cap in
place. If liquid enters the camera plug (e.g. because you forgot to put the
cap on) carefully rinse out the plug with clear water and dry carefully (with
compressed air if necessary).
6.2.1

Checks

6.2.2

Contaminated camera plug

Check all parts for damage and replace if necessary.

Clean, disinfect and then rinse the contaminated camera plug with
sterile water. Carefully dry the contacts.
Residual moisture in the contacts can impair signal transmission
(e.g. interruptions, poor contacts).

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6.3

Reprocessing procedures
IMPORTANT!
Due to the product design and the materials used it is not possible to define a specific limit of the number of
possible reprocessing cycles. The service life of medical products is defined by their function and careful
handling.
Before returning defective products for repair, these products must have gone through the entire reprocessing
cycle.
The user is obliged to make sure that the reprocessing process including the ressources, material and per
sonnel is suited to reach the required reprocessing results.
The state of the art and national laws require that validated processes be followed.

Reprocessing instructions
Product

Camera heads - heat-resistant

Preparation at the
point of use

Directly after use, remove any coarse soiling from the camera head. Do not use fixing agents or excessively hot
water (max. 40 C) as this will bake residues to the surfaces and may have a negative impact on the cleaning
success.

Transport

Store safely in a closed container, then transport the camera head to the reprocessing location, to prevent
damage and contamination.

Ultrasonic cleaning

Ultrasonic cleaning is not permissible.

Cleaning

Manual cleaning

Machine cleaning

1.Immerse in a cleaning solution for at least 5 minutes.


1.Place the camera head in the sieve tray of the
automatic washer-disinfector.
2.Brush with a soft brush for at least 5 seconds to
remove any residues.
2. Vario-TD program (without disinfection cycle):
3.Clean the buttons on the camera head with a soft
Pre-clean with cold water for 4 minutes
brush. Make sure that no contaminant residues re
Empty
main on and around the pushbuttons.
Wash
for 6the
min at
55 C
using an alkaline cleaner.
4.Rinse
the camera
head and
camera
with
deremoved
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5.Dry carefully with a cloth.
3 min of neutralization*) with warm tap water
6.Clean the glass surfaces on the objective lens with a
(max. 40 C)
cotton swab soaked with alcohol (wooden or plastic
Empty
swab carrier, not metal).
2 min of intermediate rinsing with warm tap water
(max. 40 C)
Empty
*) depending on the quality of the neutralization solu
tion, add an acid based on citric acid.
Disinfection

High Level
disinfection

1.Immerse the camera head in a certified disinfectant


solution, for exposure time refer to the manufacturer's
specifications.
2.Rinse thoroughly with demineralized** water.
3.Clean the glass surfaces with a cotton swab soaked
with alcohol.
-------

Carry out thermal machine disinfection following the


national requirements regarding the A0 value (see
DIN EN ISO 15883).

Peracetic acid:
STERIS SYSTEM 1 / STERIS SYSTEM 1E

Drying

Manual drying:
Dry the camera head with a sterile lint-free disposable
cloth or swab.

Dry the camera head using the washer-disinfector


drying cycle (max. 60 C).
If required, dry the camera head additionally using a
lint-free disposable cloth or swab.

Care

After chemothermal manual / machine disinfection, no additional care is required.

Function test,
maintenance

Visual check for cleanliness. If necessary repeat the reprocessing process until the camera head is visually
clean.

Packaging

Package the camera head for sterilization as required by the standards for the sterilization procedure.

* = if there is no subsequent sterilization, thoroughly rinse with sterile water.

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Reprocessing instructions
Product

Camera heads - heat-resistant

Sterilization

Steam sterilization:
Sterilization of products using the fractional pre-vacuum method (ISO13060/ISO17665) taking into account the
corresponding national requirements.
Temperature exposure time: 4 min at 134 C +4 C (273 F +7 F), 4 min at 132 C +4 C (270 F +7 F)
Drying time: 10 - 20 min
Maximum sterilization temperature: 138 C
Hydrogen peroxide plasma:
STERRAD 50 / 100S / 200 / NX und 100 NX , PLASMASTER 40 / 80 / 140
Gas:
Formaldehyde gas (FA), hydrogen peroxide (V-PRO1)

Storage

Store the sterilized instruments in a dry, clean and dust-free environment at temperatures between 5 C and 40
C.

Validation

During validation, the following test instructions, materials and machines were used:
Machine cleaning agent:
alkaline cleaning agent 0.5% neodisher FA (Dr. Weigert)
Manual cleaning agent:
enzymatic cleaning agent 0.5% neodisher MediClean (Dr. Weigert)
Manual disinfectant:
Cidex (Advanced Sterilization Products)
Automatic washer-disinfector:
Miele G 7735 CD
Washer-disinfector rack:
Miele E 440/1

Additional notes
and instructions

The user is obliged to validate his process in accordance with DIN EN ISO 17664.

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VERSION of
CAD-KAS PDF-Editor (http://www.cadkas.com).
IMPORTANT!
The low-temperature procedures using hydrogen peroxide and peracetic
acid are approved for endoscopes and endoscopic accessories with re
gard to their material compatibility.
By no means must these low-temperature methods be used alternately.
Possible interactions between these sterilization procedures may damage
the instruments.

6.5

Maintenance intervals
IMPORTANT!
To avoid any incidents or damage caused by aging and wear it is
necessary to service the product and the accessories at adequate
intervals. Depending on the frequency of use, but at least once a year,
have an expert check the functional and operational safety of the
equipment.

BB-A 282-03

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Changed with the DEMO VERSION of CAD-KAS PDF-Editor (http://www.cadkas.com).


This text only appears in the demo version. This text can be removed with the full version.

Technical data
Camera head

Length
of camera cable

85525922

3.0 m

85525923

5.0 m

85525924

8.0 m

Compatible
camera controller

Product no.

ENDOCAM Logic HD
Controller

552510x
552520x

IPX7

Degree of protection against the ingress of liquids

(protected against the effects of permanent submersion)

Cable length 3.0m: 0.600 kg (1.32 lbs)


Cable length 5.0m: 0.720 kg (1.58 lbs)

Weight with camera cable and camera plug

Cable length 8.0m: 0.900 kg (1.98 lbs)


Diameter, horiz. approx. 43 mm
Diameter, vertical approx. 53 mm
Length approx. 105 mm

Dimensions of camera head


Cable outlet

30

Thread for objective lens

7.1

C-mount

Operating, storage, transport and shipping

+10C
to +30C,
This text only appears in the demo version. This text can be removed with
the
full version.
Operating
conditions of CAD-KAS PDF-Editor (http://www.cadkas.com).
30% to 75% rel. humidity,
Changed with the DEMO
VERSION

atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

- 20C to +60C,
30% to 90% rel. humidity,
atmospheric pressure 700 hPa to 1060 hPa

NOTE!

To prevent damage during transport or shipment of the products we recommend using the original packa
ging material.

BB-A 282-03

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10

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7.2

Spare parts and accessories


Product no.

Designation

15135463

Protection cap for camera head

85261144

RIWO objective lens, C-mount, f = 14 mm

85261244

RIWO objective lens, C-mount, f = 24 mm

85261.172

RIWO objective lens, C-mount, f = 17 mm

85261.212

RIWO objective lens, C-mount, f = 21 mm

85261.242

RIWO objective lens, C-mount, f = 24 mm

85261504

RIWO zoom objective lens, C-mount, f = 13 -24-29 mm


Further accessories on request

7.3

Disposal of product, packaging material and accessories


For the disposal follow the laws and regulations valid in your country.
For further information please contact the manufacturer.

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Changed with the DEMO VERSION of CAD-KAS PDF-Editor (http://www.cadkas.com).

11

BB-A 282-03

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Changed with the DEMO VERSION of CAD-KAS PDF-Editor (http://www.cadkas.com).

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