BBraun
Zoom lens
33 Pages
Preview
Page 1
5.1.5
Disconnecting the endoscope
► Verify that slide 4 is opened (UNLOCK position). ► Press locking button 1. ► Remove the endoscope and release control button xxx1.
Aesculap® Zoom lens
5.1.6
Disconnecting the light cable
► Pull off the light cable from the endoscope.
Legend 1 2 3 4
Control button Black adjustment ring (for focusing at the zoom lens) Blue adjustment ring (for zoom adjustment at the zoom lens) Slide (positions LOCK/UNLOCK)
6.
Validated reprocessing procedure
6.1
General safety notes
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this.
1.
Applicable to
► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
2.
Note If there is no final sterilization, then a virucidal disinfectant must be used.
Safe handling
CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Clean the new product manually prior to its first sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Immediately replace damaged parts with authentic replacement parts.
3.
Product description
3.1
Scope of supply
Designation
Art. no.
Zoom lens (supplied unsterile)
PV124S
3.2
Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at www.aesculap-extra.net.
Components required for operation
In addition to the camera system, the following components are required for an endoscopic intervention: ■ Power cord ■ Endoscope ■ Light source ■ Light cable ■ Monitor ■ Camera
6.2
6.3
Intended use
The zoom lens PV124S serves to project the image of the optically captured operating field onto the CCD chip of the camera. It is used for all endocopes with an eyepiece according to DIN 58105 and Aesculap- 1/2" cameras with standardized C-mount thread. The zoom lens PV124S is used for endoscopy, in combination with cameras PV410-PV412 and PV420-PV422.
4.
Preparation
Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national regulations on fire and explosion protection.
5.
Dismantling prior to carrying out the reprocessing procedure
► Disassemble the product immediately after use, as described in the instructions for use of the camera head.
6.4 3.3
General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive dosages of neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking on stainless steel becoming unreadable either visually or by machine. Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging, or swelling. ■ Do not use process chemicals that cause stress cracking of plastics such as PPSU, or attack silicone softeners and cause brittleness of the material. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Preparations at the place of use
► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
6.5
Preparation before cleaning
► Reprocess the product immediately after use. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. ► Put on the cap (dampness protection) for the camera plug securely before reprocessing.
6.6
Cleaning/disinfection
6.6.1
Product-specific safety instructions for the reprocessing procedure Fire hazard! ► Do not use flammable or explosive cleaning or disinfecting solutions.
Working with the zoom lens
Note The camera system and accessories are connected as described in the respective instructions for use!
5.1
Safe operation
5.1.1
Connecting the endoscope
DANGER Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. CAUTION
► Verify that slide 4 is opened (UNLOCK position). ► Press locking button 1. ► Insert the endoscope and release control button 1. ► If required, close slide 4 (position LOCK) to secure the endoscope against rotation.
5.1.2
Connecting the light cable
Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. CAUTION
► Connect the light cable at the endoscope. ► Switch on the light source at a low light intensity setting.
5.1.3
Adjusting the zoom lens
► Turn the zoom lens to its intended position.
The zoom lens can be set to any position.
5.1.4
Adjusting the image focus and enlargement
► Adjust the intensity of the light source until sufficient illumination is achieved. ► Turn blue adjustment ring 3 to adjust the image focus. ► Turn black adjustment ring 2 to adjust the image enlargement.
Note The image enlargement is freely adjustable.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – approved for aluminum, POM, high grade steel (1.4305/1.4310), glass (BK7) and PPSU. – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 45 °C.
6.6.2
Sterilization through the Sterrad® sterilization process
Validated cleaning and disinfection procedure
Validated procedure
Special features
Reference
Manual cleaning and wipe disinfection
■ When cleaning instruments with
Chapter Manual cleaning/disinfecting and subsection:
movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
■ Chapter Manual cleaning and wipe
► Sterilize by the Sterrad® sterilization process Sterrad® 50, Sterrad® 100S, Sterrad®200, observing the following
rules: Follow the Sterrad® system manufacturer's instructions. Use of a biological indicator is recommended to confirm effective sterilization. Ensure proper venting of openings and canals by unscrewing the cap from the camera plug at least 5 minutes prior to using the camera.
disinfecting
■ Drying phase: Use a lint-free cloth ■ Ensure that the product is posi-
Gas sterilization It is the responsibility of the user to decide if this process is effective in achieving the intended sterilization effect. ► Sterilization with ethylene oxide (EO),
tioned in such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.)
6.7
Note The Sterrad® sterilization process can cause cosmetic changes to the camera head and cable. These changes do however not affect its functionality.
Procedure
Temperature
Application
Ethylene oxide (EO)
52 °C
180 min with 100 % EO; 600 mg/l; Chamber humidity 45 % to 75 % gas exposure 8 hours
Manual cleaning/disinfecting
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.
6.7.1
6.11 Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
Manual cleaning and wipe disinfecting
To achieve a sterility assurance level of 10-6 , Aesculap recommends the following parameters:
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Cleaning
RT (cold)
-
-
D–W
-
Sterilization method
Temp.
Time
Minimum drying time
II
Drying
RT
-
-
-
-
Prevacuum
270 °F/275 °F
4 min
20 min
III
Wipe disinfection
-
>1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
IV
Final rinse
RT (cold)
0.5
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature
RT:
Phase I ► Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe. Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
6.8
Inspection, maintenance and checks
► Allow the product to cool down to room temperature. ► Set aside the product if it is damaged. ► Lightly lubricate moving parts (e.g. joints and links) with maintenance oil suitable for the respective sterilization
process (e.g. Aesculap-STERILIT® Spray JG600 or maintenance oil JG598). ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functioning properly and not damaged (e.g. insulation), and do not have any loose, bent, broken, cracked, worn, or fractured components. ► Check for compatibility with associated products. ► Set aside the product if it is damaged.
Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters*
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.
6.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
7.
Technical Service
► For service and repairs, please contact your national B. Braun/Aesculapp agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Repairs processing for camera systems and accessories: AESCULAP FLEXIMED GmbH Robert-Bosch-Strasse 1 79211 Denzlingen / Germany Phone: +49 (0) 7666 / 9321-0 Fax: +49 (0) 7666 / 9321-580 E-Mail: [email protected] www.aesculap-fleximed.de Telephone hotline for technical assistance with electrical devices and device combinations: Phone: +49 (7461) 95 -1601 Other service addresses can be obtained from the address indicated above.
8.
Technical data
Classification acc. to Directive 93/42/EEC Art. no.
Designation
Class
PV124S
Zoom lens
I
Art. no.
Designation
PV124S
Zoom lens
–
Connecting thread C-Mount
–
FFD: 19.5 mm
6.10 Sterilization
–
Focal length: 25 mm to 50 mm
Note The camera system and accessories are sterilized as described in the respective instructions for use!
–
Weight: 125 g
6.9
Packaging
► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Pack the product in such a way that the packaging will prevent recontamination of the product in the period
between reprocessing and reuse.
Damage to the camera control unit by sterilization! ► Do not sterilize the camera control unit under any circumstances. ► Clean the camera control unit by surface disinfection only.
8.1
Ambient conditions Operation
CAUTION Temperature
CAUTION
Damage to the camera head or the zoom lens caused by inappropriate sterilization processes! ► Never sterilize the camera head or the zoom lens with steam or in an autoclave. ► Do not carry out chemical sterilization.
Relative humidity
► Use Aesculap disposable sterile covers JG904. Follow the instructions for use of the sterile covers.
The camera head and the zoom lens can be sterilized through the following processes. The material will not be adversely affected by these sterilization processes, even if sterility is not achieved. It is the responsibility of the user to decide if this process is effective in achieving the intended sterilization effect: ■ Sterrad® sterilization process: using Sterrad® sterilizers Sterrad® 50, Sterrad® 100S, or Sterrad® 200 ■ Gas sterilization
Atmospheric pressure
Storage and transport
9.
Disposal
Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap
agency, see Technical Service.
10.
Distributor in the US/Contact in Canada for product information and complaints
3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 012280
09/12
V6
Änd.-Nr. 45844