BBraun
Light rod ME421R and light cable ME422R
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Aesculap® Light rod ME421R and light cable ME422R
CAUTION
Legend 1 2 3 4 5 6
Endoscope adapter (with Aesculap/Storz connector) Endoscope-side cable end Light source adapter (with Aesculap/Storz connector) Light-source-side cable end Adapter (endoscope) disassembled Adapter (light source) disassembled
Symbols on product and packages
Risk to patients due to disconnection of the light rod in situ! ► Insert the light rod into the light clip after the clip is firmly attached to the Spyder blade. ► Ensure that the clip is attached firmly so that it doesn't come off unexpectedly during use. ► If the clip feels loose, bend it lightly to create a better press fit. ► When inserting the light rod, make sure that the edge of the grey flexible portion does not catch on the edge of the light rod clip.
► Hold the light-source-side cable end 4 against the light and check that the endoscope-side cable end 2 illumi-
nates evenly or use light cable tester OP917. ► With the light source already switched on, turn the light control to the minimum setting in order to avoid blind-
ing and heat development. ► Insert the light-source-side cable end 4 into the light source so that it audibly clicks into place. ► Screw the endoscope-side cable end 2 onto the endoscope's optical-fiber connector. ► Use the light cable only with halogen light sources equipped with a spare lamp, with xenon light sources, or with
LED light sources. ► To avoid burns caused by the hot endoscope-side cable end 2, adjust the light source to the minimum required
power for optimal illumination of the endoscopic image. Caution, general warning symbol Caution, see documentation supplied with the product
Date of manufacture
Classification type CF
Steam sterilization at temperatures up to 134 °C
► Always observe the respective manufacturer’s instructions when using the light cable in combination with other
devices, endoscopes, and instruments.
Disassembling ► Unscrew adapter 1 from the endoscope-side cable end 2. ► Unscrew adapter 3 from the light-source-side cable end 4.
Assembling ► Screw adapter 6 onto the light-source-side cable end 4. ► Screw adapter 5 onto the endoscope-side cable end 2.
Validated reprocessing procedure General safety instructions
High level of light transmission optimized for Full HD endoscope and cameras
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.
Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
Intended use The light cable ME422R is used for transmitting the light from the cold light source to the light rod. The light rod ME421R is used together with the Spyder retractor system to apply intense light to the area being examined. The use of this instrument for tasks other than those indicated above may damage or potentially break the instrument and is not permitted.
Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! Fiber fracture of the light rod or light cable due to incorrect handling! ► Do not kink the light rod or light cable. WARNING The product is supplied in an unsterile condition and must be reprocessed and sterilized prior to use. The light rod is validated for 150 steam sterilization cycles. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial 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. ► Replace any damaged components immediately with original spare parts. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).
Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING
WARNING
CAUTION
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
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 measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. 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. 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 of 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 metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use.
Preparations at the place of use Risk of injury due to excessive heat! ► Only use light rod ME421R with light cable ME422R. ► When using a light source, make sure that the light rod and the end of the light cable do not touch human tissue or highly inflammable or heat-sensitive materials. ► Do not touch the distal end of the light cable. ► Only use light sources of a power rating of up to 300 W. Fiber fracture of the light rod or light cable due to incorrect handling! The light rod and the light cable contain glass fibers that can be damaged if the flexible part is bent too acutely (Less than 19 mm radius of curvature). ► Take care when bending the grey flexible part of the light rod or over the top of the blade and out of the way.
► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning ► Carry out non-fixating/NaCl-free pre-cleaning immediately after use. ► Dismantle the product prior to cleaning, see Disassembling. ► Coil up the light cable to a coil with a diameter greater than 10 cm. Do not kink the cable.
► To clean with the brush, insert the brush with its metal tip into the channel and slowly extract it from the other
Cleaning/disinfection
end as soon as it emerges there. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
Product-specific safety notes on the reprocessing procedure
corrosion.
Damage to the optical system caused by connections coming loose in the ultrasound bath! ► Never use ultrasound treatment for cleaning the product.
Phase II ► Completely rinse (through) the product 3 times for at least 1 min, using clean, fresh water for each rinse. Mobilize non-rigid components, e.g. set screws, joints, etc. to the positive stop, 3 times in each direction. ► For each rinsing cycle, rinse through lumens and channels with a single-use syringe (20ml) at least 5 times. ► Allow water to drip off for a sufficient length of time.
Damage to the light rod caused by mechanical cleaning! ► Only clean the light rod manually.
Phase III ► Fully immerse the product in the disinfecting solution. Check that all accessible surfaces are moistened and all lumens, channels and complex geometries are bubble-free and filled with cleaning solution. ► Mobilize non-rigid components, e.g. set screws, joints, etc. to the positive stop, 3 times in each direction.
CAUTION
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 – are approved for rigid/flexible endoscopes, – 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 55 °C.
CAUTION
► To avoid residues/proteins becoming fixated, do not use aldehydes or alcohols for pre-cleaning. ► Only use bactericidal, fungicidal, and virucidal disinfectants. ► Preferably use thermal disinfecting processes. ► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.
Manual cleaning/disinfection
Phase IV ► Completely rinse (through) the product 3 times for at least 2 min, using clean, fresh water for each rinse. Mobilize non-rigid components, e.g. set screws, joints, etc. to the positive stop, 3 times in each direction. ► For each rinsing cycle, rinse through lumens and channels with a single-use syringe (50 ml) at least 5 times. ► Allow water to drip off for a sufficient length of time. Phase V ► Thoroughly dry the external surfaces of the product with a soft, lint-free disposable wipe or with medical compressed air. ► Thoroughly blow-dry lumens and channels with air from a single-use syringe (20 ml). Do not use compressed air for this purpose.
Mechanical cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning of the optical fibers and adapter with a brush
► 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. ► Do not kink the light cable. ► Leave the light cable immersed in the disinfectant solution for no longer than 1 hour. ► To remove residues of cleaning agents/disinfectants, always wipe the illumination surface(s) of the light cable with a swab moistened in alcohol.
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemicals
I
Cleaning
RT (cold)
3
2
DW
–
II
Rinsing
RT (cold)
0.5
-
DW
–
Manual cleaning with immersion disinfection
DW: RT:
Light cable ME422R Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemicals
I
Cleaning
35-45 95-113
15
0.8
DW
Cidezyme/Enzol
II
Intermediate rinse
RT (cold)
2x1
-
DW
-
III
Disinfection
20-25 68-77
12
0.55
DW
Cidex OPA (process solution 0.55% orthophtalaldehyde)
IV
Final rinse
RT (cold)
3x1
-
DMW sterile
-
V
Drying
RT
-
-
-
-
DW: DMW:
Drinking water Demineralized water (low microbiological contamination: max. 10 microorganisms/ml, low endotoxin: max. 0.25 endotoxin units/ml) Room temperature
RT:
Drinking water Room temperature
Phase I ► Fully immerse the product in water. Ensure that all accessible surfaces are moistened. ► Use a suitable soft cleaning brush to clean the product until all visible residues have been removed from the surface. Brush through all surfaces that are not accessible to visual inspection, e.g., in products with hidden crevices, lumens, or complex geometry, for at least 1 minute or until no more residues can be removed. ► During cleaning, mobilize non-rigid components, such as set screws, joints, slides, etc., 3 times in each direction to the positive stop. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion. Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► During cleaning, mobilize non-rigid components, such as set screws, joints, slides, etc., 3 times in each direction to the positive stop.
Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots). Phase
Step
T [°C/°F]
t [min]
Water quality
Chemicals
I
Pre-rinse
<25/77
2
DW
-
II
Cleaning
55/131
10
DMW
neodisher MediClean 0.5% solution (5 ml/l)
III
Rinse I
>10/50
1
DW
-
IV
Rinse II
>10/50
1
DMW
-
V
Thermal disinfection
90/194
5
DMW
-
VI
Drying
-
-
-
According to the program for the cleaning and disinfection device
Light rod ME421R Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemicals
I
Cleaning
RT (cold)
15
1.0
DW
B. Braun Cleaner N
II
Intermediate rinse
RT (cold)
3x1
-
DW
-
III
Disinfection
RT (cold)
15
1.5
DMW sterile
B. Braun Helipur H Plus N
IV
Final rinse
RT (cold)
3x2
-
DMW sterile
-
V
Drying
RT
-
-
-
-
DW: DMW: RT:
Drinking water Demineralized water (low microbiological contamination: max. 10 microorganisms/ml, low endotoxin: max. 0.25 endotoxin units/ml) Room temperature
Phase I ► Fully immerse the product in the cleaning/disinfecting solution. Check that all accessible surfaces are moistened and all lumens, channels and complex geometries are bubble-free and filled with cleaning solution. ► Clean the outer surfaces of the immersed product with a soft, lint-free, disposable wipe. ► Brush through all areas not accessible to visual inspection, e.g. in products with hidden crevices, lumens (e.g. open/working channel) or complex geometries, for at least 1 min or until no more residues can be removed. Mobilize non-rigid components, e.g. set screws, joints, etc. to the positive stop, 3 times in each direction. ► After cleaning, thoroughly rinse through these components (at least five times) with the cleaning solution, using a disposable syringe (20 ml). ► Clean open/working channels with the cleaning brush supplied with the product (PF893800) for at least 1 min. ► After cleaning, thoroughly rinse through these components (at least five times) with the cleaning solution, using a disposable syringe (20 ml).
DW: DMW:
Drinking water Demineralized water (low microbiological contamination: max. 10 microorganisms/ml, low endotoxin: max. 0.25 endotoxin units/ml)
► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfection process if necessary.
Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and
free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products. ► Hold the light-source-side cable end 4 against the light and check that the endoscope-side cable end 2 illumi-
nates evenly. –or– ► Test the transmission of the light cable with Aesculap light cable tester OP917.
Accessories/Spare parts
Packaging ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Art. no.
Designation
OP917
Light cable tester
Sterilization Damage to the fiber-optical system caused by flash sterilization! ► Do not flash sterilize the product. ► Do not expose the product to temperatures above 134 °C. CAUTION
Other light source and endoscope adapters are available on request from AESCULAP FLEXIMED GmbH, see Technical Service.
Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Damage to the light rod caused by Sterrad sterilization process! ► Only sterilize the light rod using steam sterilization. CAUTION The following processes are suitable for sterilizing the light cable: ■ Steam sterilization ■ Sterrad sterilization process: with Sterrad sterilizers Sterrad 50, Sterrad 100S, or Sterrad 200 ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by opening any valves and faucets).
Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets). ► Validated sterilization process
– Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.
Sterrad sterilization process Sterrad 50, Sterrad 100S, and Sterrad 200 Note The product must be disassembled before applying the Sterrad sterilization process. Note The Sterrad sterilization process can cause cosmetic changes to the product. These changes will, however, not affect its functionality. ► Disassemble the product. ► Only use Sterrad sterilization process 50, 100S, or 200 to sterilize light cables whose endoscope-side cable end
bears the SDS symbol for low-temperature and plasma sterilization. ► Unscrew dismountable parts of the light cable, see Disassembling. ► Sterilize using the Sterrad sterilization process 50, 100S, or 200, observing the following rules:
– Follow the Sterrad system manufacturer's instructions. – Use of a biological indicator is recommended to confirm effective sterilization.
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. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method
Temp.
Time
Minimum drying time
Prevacuum
270 °F/275 °F
4 min
20 min
*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.
Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Coil up the light cable to a coil with a diameter greater than 10 cm. Do not kink the cable.
Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Prior to dispatching the product for repairs: – Clean, disinfect, and sterilize the light cable as far as possible, and mark it as “disinfected” or “sterilized”. – Pack the light cable in such a way that it will be protected against transport damage. Service addresses 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 Other service addresses can be obtained from the address indicated above.
Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 014092
2018-01
V6
Änd.-Nr. 57966