BB-A282-03 Manual Tecnico
BB-A282-03 Manual Tecnico
BB-A282-03 Manual Tecnico
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Instruction Manual
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BB-A 282-03 / en /
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Level of danger
WARNING!
CAUTION !
IMPORTANT !
NOTE !
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
[email protected]
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
[email protected]
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
[email protected]
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
[email protected]
www.richardwolf.uk.com
[email protected]
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
[email protected]
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
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
BB-A 282-03
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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.
1.3
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
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
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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BB-A 282-03
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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
1.2
1.3
1.4
Serial no.
1.5
Product no.
1.6
Camera plug
1.7
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
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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that This
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largefull
focal
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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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Abb. 3
Abb. 2
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Abb. 4
BB-A 282-03
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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
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6.1
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
Checks
6.2.2
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
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
Cleaning
Manual cleaning
Machine cleaning
High Level
disinfection
Peracetic acid:
STERIS SYSTEM 1 / STERIS SYSTEM 1E
Drying
Manual drying:
Dry the camera head with a sterile lint-free disposable
cloth or swab.
Care
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.
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Reprocessing instructions
Product
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.
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.
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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
30
7.1
C-mount
+10C
to +30C,
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30% to 75% rel. humidity,
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- 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.
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10
7.2
Designation
15135463
85261144
85261244
85261.172
85261.212
85261.242
85261504
7.3
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11
BB-A 282-03
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