Arthrex AR-3210-0006 User manual
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C-Mount HD Optical Zoom Coupler Instructions for Use
Gebrauchsanweisung
Instructions d’utilisation
Instrucciones de uso
Istruzioni per l'uso
Instruções de utilização
950-0069-00-ML-C
Brugsanvisning
Bruksanvisning
Gebruiksaanwijzing
Instrukcja obsługi
Návod k použití
Návod na použitie
Uputstvo za upotrebu
Bruksanvisning
Käyttöohje
Instrucțiuni de utilizare
Руководство по
эксплуатации
This manual contains information that is subject to copyright. All
rights reserved. This manual should not be photocopied, dupli-
cated on microfilm or otherwise copied or distributed, complete-
ly or in part, without the approval of W.O.M. WORLD OF
MEDICINE GmbH.
We reserve the right to technical changes without prior notification due to the
continuous further development of our products. Function or design may par-
tially differ from the description in the manual. Please contact us for addition-
al information about this or any of our other products.
Some of the parts and equipment referred to in this manual bear registered
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that the absence of the trademark indicates that any given designation is not
subject to trademark protection.
Users of this product should not hesitate to point out to us any errors or un-
clarities in this manual.
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Durch die ständige Weiterentwicklung unserer Produkte behalten wir uns
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vación con respecto a posibles fallos, incongruencias o explicaciones poco
claras que puedan encontrarse en las presentes instrucciones de uso.
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Grazie al continuo sviluppo dei nostri prodotti, ci riserviamo il diritto di appor-
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possono scostarsi in parte dalla descrizione contenuta nel presente manuale.
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CE marking according to Directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/EWG
Marquage CE conforme à la directive 93/42/CEE
Identificación CE conforme a la directiva 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE
Distintivo CE conforme a Directiva 93/42/CEE
CE-sertifisering i henhold tiil direktiv 93/42/EØF
CE-merkintä 93/42/ETY-direktiivin mukaisesti
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Marcaj EC conform Directivei 93/42/CEE
Маркировка CE согласно директиве 93/42/EEC Type: E240/10000017723 02/2017-03/Kubetzek
Manufacturer/Hersteller/Fabricant/Fabricante/Fabbricante/Fabricante/Produsenten
Valmistaja/Producent/Tillverkare/Fabrikant/Producent/Výrobce/Výrobca/
Proizvođač
Producător/Производитель
:
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
10587 Berlin, Germany
Phone: +49 30 39981-550
Fax: +49 30 39981-545
E-mail: [email protected]
Distributor/Vertreiber/Distributeur/Distribuidor/Distributtore/Distribuidor
Distributør/Myyjä/Sælger/Distributör/Distributeur/Dystrybutor
Distributor/Distribútor/Distributer/Distribuitor/
Дистрибьютор
:
Arthrex, Inc.
1370 Creekside Blvd
Naples, FL 34108 USA
Phone: + 1-(800) 934-4404
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Phone: +49 89 909005-0
Fax: +49 89 909005-2601
www.arthrex.de
U ovom priručniku sadržane su zaštićene informacije koje su
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Acest manual conţine informaţii protejate prin dreptul de proprie-
tate stipulat în legea dreptului de autor.
Toate drepturile sunt
protejate. Fără acordul explicit, scris al WORLD OF MEDICINE
GmbH
este interzisă multiplicarea sau distribuirea acestui man-
ual, fie sub formă completă, fie parţial, prin fotocopii, microfilm sau alte pro-
cedee.
Datorită dezvoltării permanente a produselor noastre ne rezervăm dreptul de
a opera fără aviz modificări de natură tehnică.
Modul de funcţionare sau as-
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Nici nu se poate stabili dacă au fost protejate printr-
un patent sau brevet de exploatare.
Firma
WORLD OF MEDICINE GmbH
este recunoscătoare utilizatorilor de
produse
WORLD OF MEDICINE GmbH
pentru fiecare observaţie privind po-
sibile erori sau neclarităţi ale acestui manual.
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Настоящее руководство содержит информацию,
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Table of contents
EN
Table of contents
1 Important User Notes ......................................................................................................................................................... 3
2 Safety Information.............................................................................................................................................................. 4
3 General Information ........................................................................................................................................................... 5
3.1 Device Description ................................................................................................................................................................... 5
3.1.1 Selecting the Focal Length..................................................................................................................................................... 5
3.1.2 Selecting the Focus Area ........................................................................................................................................................ 7
3.2 Intended Use.............................................................................................................................................................................. 7
3.3 Contraindications..................................................................................................................................................................... 7
3.4 General Warnings and Precautions .................................................................................................................................... 7
3.4.1 General Warnings .................................................................................................................................................................... 7
3.4.2 Precautions................................................................................................................................................................................. 8
4 Initial Startup ...................................................................................................................................................................... 9
4.1 Connecting video lens to a C-mount camera................................................................................................................... 9
4.2 Connection of the video lens with the endoscope ......................................................................................................... 9
4.3 Using Sterile Covers/Sleeves................................................................................................................................................. 10
5Visual Inspection and Function Testing.............................................................................................................................. 11
5.1 Visual inspection ...................................................................................................................................................................... 11
5.2 Function test.............................................................................................................................................................................. 11
6 Reprocessing and Maintenance.......................................................................................................................................... 13
6.1 Preparing for Reprocessing.................................................................................................................................................... 13
6.2 Automated Cleaning ............................................................................................................................................................... 14
6.2.1 Automated Disinfection......................................................................................................................................................... 14
6.2.2 Automated Drying ................................................................................................................................................................... 14
6.3 Manual cleaning....................................................................................................................................................................... 15
6.3.1 Manual Disinfection................................................................................................................................................................ 16
6.3.2 Manual Drying .......................................................................................................................................................................... 16
6.4 Reprocessing Validation ......................................................................................................................................................... 16
6.4.1 Manual reprocessing............................................................................................................................................................... 16
6.4.2 Automated reprocessing........................................................................................................................................................ 16
7 Sterilization......................................................................................................................................................................... 17
7.1 Packaging.................................................................................................................................................................................... 17
7.2 Moist heat sterilization .......................................................................................................................................................... 17
7.3 Low-temperature sterilization.............................................................................................................................................. 18
7.4 Storage ........................................................................................................................................................................................ 18
7.5 Sterilization Validation ........................................................................................................................................................... 18
8 Technical Data..................................................................................................................................................................... 19
9 Service Address and Repairs ............................................................................................................................................... 20
Index.................................................................................................................................................................................... 21
Important User Notes
3
EN
1Important User Notes
Read the instructions for use carefully and become familiar with the operation
and function of the device and the accessories before use during surgical proce-
dures. Non-observance of the instructions listed in this manual can lead
•to life-threatening injuries of the patient,
•to severe injuries of the surgical team, nursing staff or service personnel, or
•to damage or malfunction of device and/or accessories.
Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and
technical data of the product through continued development of its products.
Please noteThe words WARNING, CAUTION, and NOTE carry special meanings. Sections
marked with these words must be given special attention.
WARNING!
The safety and/or health of the patient, user, or a third party are at risk. Comply
with this warning to avoid injury to the patient, user, or third party.
CAUTION!
These paragraphs include information provided to the operator concerning the
intended and proper use of the device or accessories.
NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.
4
Safety Information
EN 2 Safety Information
Federal Law (only for U.S. market) CAUTION: Federal Law restricts this device to sale by or on the order of a physi-
cian.
Exclusion of liability The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
•the device and/or the accessories are improperly used, prepared, or main-
tained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the de-
vice or accessories;
•unauthorized persons open the device;
•the prescribed inspection and maintenance schedule is not adhered to.
The handing over of technical documents does not constitute authorization to
make repairs or alterations to the device or accessories.
The manual is intended as a tool for the use of the C-Mount HD Optical Zoom
Coupler. It is not intended as a reference for surgical endoscopy procedures or
techniques.
WARNING: Modifying the device C-Mount HD Optical Zoom Coupler is not per-
mitted.
Intended use The device may be used only as intended (chapter 3.2, page 7).
Contamination Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in this User Manual. If this is not
possible,
•the product must be clearly marked with a contamination warning and
• must be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Care and maintenance The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protec-
tion of the patient and the operating team, check that the device is complete and
functional before each use.
Maintenance of the device may not be performed during the operation.
Disposal Comply with country-specific regulations and laws as well as the local regula-
tions when disposing of the product.
General Information
5
EN
3General Information
3.1 Device Description
The C-Mount HD Optical Zoom Coupler, hereafter called "video lens", can be used
in laparoscopy, arthroscopy and hysteroscopy procedures.
Properties of the video lensThe lens has a focal length range of 14 mm to 29 mm. This allows the user to
choose a circular or a full screen depending on the diameter of the endoscope.
Interfaces/PortsThe video lens is designed for the use of endoscopes with a proximal end in ac-
cordance with DIN 58105 and endoscopic cameras with a C-mount connection
according to SMPTE 76 / ISO 10935.
CAUTION!
Do not use an endoscope with a proximal interface that does not comply with
the currently valid version of the standard DIN 58105!
CAUTION!
Do not use an endoscopy camera with a distal interface that does not comply
with the currently valid version of the standard SMPTE 76 / ISO 10935!
Design of the video lensThe video lens consists of three control elements:
•Quick-release coupling for connecting with the endoscope
• Focus adjustment ring to focus the desired lens level
•Zoom adjustment ring to change the desired image size
3.1.1 Selecting the Focal Length
Zoom functionThe focal length of the video lens determines the size of the image that is dis-
played on the monitor. The focal length of the video lens is changed by using the
zoom ring (3), (Fig. 3-1 "Design of the video lens").
When using a short focal length, the entire endoscopic image information is de-
picted in a circular display (Fig. 3-2 "Circular depiction with short focal length").
Fig. 3-1 Design of the video lens
(1) Quick-release coupling (endoscope)
(2) Focus adjustment ring
(3) Zoom adjustment ring
(4) C-mount connection (camera)
(2)
(1) (3)
(4)
6
General Information
EN
If the zoom function is used and the image is optically enlarged, e.g., for a full
screen on the monitor, endoscopic image information on the monitor is lost (Fig.
3-3 "Loss of image information with zoom function").
CAUTION!
Using a full screen size results in a loss of image content!
CAUTION!
Zooming may cause the loss of image orientation due to missing image informa-
tion.
Fig. 3-2 Circular depiction with short focal length
(1) Monitor
(2) Endoscopic image information
(1)
(2)
Fig. 3-3 Loss of image information with zoom function
(1) Monitor
(2) Endoscopic image information
(3) Lost endoscopic image information
(1) (2)
(3)
General Information
7
EN
3.1.2 Selecting the Focus Area
Focus functionUse the focus adjustment ring (2) (Fig. 3-1 Design of the video lens, page 5) to
focus the desired image level.
3.2 Intended Use
The video lens serves the transfer, focusing, and magnified depiction of the sur-
gical field to be viewed during minimally invasive surgery. It is used as a link be-
tween the endoscope and endoscopic camera head with C-mount connector.
3.3 Contraindications
•The video lens may not be used for the visualization of cavities if endoscopic
surgery is contraindicated. Refer to your endoscope's manual for absolute and
relative contraindications.
•The video lens may not be used if the attending physician deems its use a haz-
ard to the health of the patient.
•The video lens may not be used if the rules and standards described in this User
Manual regarding environmental conditions are not met.
3.4 General Warnings and Precautions
3.4.1 General Warnings
WARNING!
Professional qualification
The Instructions for Use do not include descriptions or instructions for surgical
procedures/techniques. It is not suitable for training physicians in the use of sur-
gical techniques. Medical peripherals and devices may be used only by physi-
cians or medical assistants with the appropriate technical/medical qualifications
working under the direction and supervision of a physician.
WARNING!
Functional test
The functional test must be performed prior to each surgery.
WARNING!
Sterile mediums and accessories
Always work exclusively with sterile substances and mediums, sterile fluids, and
sterile accessories if so indicated.
WARNING!
Replacement device and accessories
In case the device or any of the accessories fail during surgery, a replacement de-
vice and replacement accessories should be kept within close proximity to be
able to finish the operation with the replacement components.
8
General Information
EN WARNING!
Device defect
If a device defect is suspected or confirmed, do not use it. Make sure the device
can no longer be used until a qualified service technician conducts the appropri-
ate tests and repairs.
WARNING!
Hot surface on the endoscope
The fiber optic cable connector on the endoscope may become very hot. Always
use fiber optic cables with a cross sectional area matching the endoscope.
WARNING!
Endoscopes and peripheral devices
The device may only be connected with endoscopes and additional accessories
designed for and featuring the technical specification permitting such a com-
bined use. Endoscopes and related accessories must comply with requirements
of the standards IEC 60601-2-18 / EN 60601-2-18, and ISO 8600 for endoscopy
devices and IEC 60601-1 / EN 60601-1 for electrical medical devices in the most
recently amended version.
Persons connecting additional devices to signal outputs or signal inputs is con-
figuring a medical system and as such is responsible for complying with require-
ments of the standard IEC 60601-1 / EN 60601-1 in the most recently amended
version.
3.4.2 Precautions
CAUTION!
Do not use the video lens in a strongly magnetic environment (e.g., open MRI)!
CAUTION!
Compatibility check of the endoscopic system
The compatibility of the endoscopic device with all accessories and with any
electrically operated endotherapy devices with regard to the safety criteria de-
fined in the instructions for use must be checked before each use.
CAUTION!
Endoscopes and accessories
The outer surface of the endoscope and each endoscopically usable piece of ad-
ditional equipment has to be checked to ensure that the area is free of rough
spots and/or sharp edges that could harm the patient.
Initial Startup
9
EN
4Initial Startup
Delivery inspectionAlways check all parts and accessories of the device immediately after receiving
the shipment. The manufacturer considers only replacement claims that have
been immediately submitted or reported to a sales representative or an autho-
rized service company.
WARNING!
The video lens is supplied non-sterile and must be thoroughly cleaned and disin-
fected prior to first use and before each further use (chapter 6 Reprocessing and
Maintenance, page 13). If the video lens is used without sterile cover, it must be
sterilized after disinfection (chapter 6 Reprocessing and Maintenance, page 13)!
4.1 Connecting video lens to a C-mount camera
Insert the video lens with the threaded connection into the threaded mounting
of the camera head (A). Turn the video lens clockwise up to the stop (B). The video
lens is now fixed firmly to the camera head and ready for connecting to the en-
doscope (Fig. 4-1). To disconnect the video lens from the camera head, proceed in
reverse order.
4.2 Connection of the video lens with the endoscope
Using the quick-release couplingSimultaneously press the two control elements of the quick-release coupling and
insert the endoscope (3) with the eyepiece into the receptacle of the quick-re-
lease coupling (A). The connection with the endoscope is made automatically by
releasing the two control elements of the quick-release coupling (B) (Fig. 4-2
"Open and close quick-release coupling").
Fig. 4-1 Connecting lens to a C-mount
camera
Fig. 4-2 Open and close quick-release
coupling
(1) Camera
(2) Video lens
(3) Endoscope
(1) (2) (3)
10
Initial Startup
EN 4.3 Using Sterile Covers/Sleeves
The video lens must be cleaned, disinfected, and sterilized prior to use in the op-
erating room, (chapter 6 Reprocessing and Maintenance, page 13)!
If the video lens has not been sterilized, it must be used with a sterile cover!
WARNING!
To prevent contamination of the sterile field and possibly infecting the patient,
endoscope, video lens, and camera must be sterile when being used. The sterility
of the two components may be achieved by the use of a sterile cover or sleeve,
for example. Please make sure to read chapter 6 Reprocessing and Maintenance,
page 13 for additional information.
CAUTION!
Use commercially available sterile covers/sleeves.
Sterile cover/sleeve Use the sterile cover/sleeve as follows: Position and adjust cover/sleeve so that
the lens remains free.
Attach sterile cover/sleeve (1) with adhesive tape (3) to endoscope (4) (Fig. 4-3
"Layout/fastening: Sterile cover/sleeve"). Comply with the instructions and notes
of the manufacturer of the covers or sleeves.
Fig. 4-3 Layout/fastening: Sterile cov-
er/sleeve
(1) Sterile cover/sleeve
(2) Camera head
(3) Adhesive strips
(4) Endoscope
(1) (3)
(2) (4)
Visual Inspection and Function Testing
11
EN
5 Visual Inspection and Function Testing
Perform a visual inspection and function test before and after each use!
WARNING!
A damaged or incomplete video lens can no longer be used. Injury to patients, us-
ers or third parties is possible.
WARNING!
A damaged video lens must be sent to the manufacturer for repair. Unauthorized
repairs and modifications to the video lens are not allowed.
5.1 Visual inspection
Check the video lens for the following:
•Damaged / sharp edges
•Missing or loose components
• Visibility of the label on the video lens (proximal side)
•Defective optical surfaces
•Moisture in the video lens
• Optical surfaces should be clean and free of dust before connecting to the cam-
era and the endoscope!
5.2 Function test
•The video lens must be easy to screw onto the C-mount connection of the cam-
era head.
• Make sure the video lens was screwed up to the stop into the C-mount thread
of the camera and is not loose.
•Make sure the zoom adjustment ring and the focus adjustment ring can be ro-
tated.
•The latch of the quick-release coupling is closed while in normal state.
• Opening the quick-release coupling must be possible by simultaneously press-
ing the two control elements of the quick-release coupling.
•The endoscope must be securely attached to the eyepiece of the quick-release
coupling.
•Rotating the zoom adjustment ring must result in a change of the image size.
•Rotating the focus adjustment ring must result in a change of the image sharp-
ness.
In case of a blurry or fuzzy image, check the optical surfaces for dirt and clean
them with a cotton swab dipped in alcohol (Fig. 5-1, page 11). Please do not use
any metal objects for cleaning.
Fig. 5-1 Cleaning optical surfaces
12
Visual Inspection and Function Testing
EN Replace the video lens, if:
•the connection to the endoscope or the camera is not secure
•pressing zoom and focus adjustment ring does not result in image changes
• the picture quality is not sufficient despite cleaning the lens protection win-
dow
•sharp edges or deformation are seen on the video lens
Table of contents
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