Carl Zeiss
6x sterilizable caps (OPMI LUMERA 700)
Reprocessable Products (Asepsis) Instructions for Use
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Instructions for Use Reprocessable Products (Asepsis)
Instructions for Use
EN
1. Information about the Reprocessing Instructions 1.1. Scope of application The reprocessing instructions specified here apply to the following reprocessable products (asepsis): Ref. No.
Designation
Set No.
Designation
000000-1040-600 Sterilizable metal sleeve
305810-9011-000 2x sterilizable metal sleeves
304156-0400-810 Sterilizable contact guard
304156-9900-000 2x contact guard (EyeMag Pro F/S)
302501-9060-000 Sterilizable handgrip
305810-9010-000 6x sterilizable handgrips (OPMI VISU) 305810-9009-000 2x sterilizable caps (VISULUX)
302550-9022-000 Sterilizable cap 000000-1040-600 Sterilizable metal sleeve 302613-9002-000 Sterilizable handgrip 302627-9001-000 Sterilizable cap 302681-1701-810
Sterilizable cap
304111-0180-000
Sterilizable contact guard
305808-0000-000 Sterilizable handgrip cover
305810-9016-000 2x sterilizable handgrips (rotatable 360°) 302627-9910-000 4x sterilizable caps (OPMI MD) 305810-9017-000 6x sterilizable caps (OPMI LUMERA 700) 304111-8180-000 2x contact guard (EyeMag Smart)
305810-0100-810 Sterilizable cap, 22 mm
305810-9012-000 2x sterilizable handgrip covers (OPMI 1 FC) 305810-9001-000 6x sterilizable caps, 22 mm
305810-0101-810
Sterilizable cap, 12 mm
305810-9015-000 2x handgrips, 6x sterilizable caps, 22 mm 305810-9002-000 6x sterilizable caps, 12 mm
305810-0102-810
Sterilizable cap, 49 mm
305810-0104-810 Sterilizable handgrip cover
305810-9003-000 6x sterilizable caps, 49 mm (180° tiltable tube) 305810-9004-000 4x sterilizable handgrip covers
305810-0108-810 Sterilizable sleeve
305810-9006-000 6x sterilizable sleeves
305810-0109-810 Sterilizable caps, 27 mm
305810-9008-000 6x sterilizable caps, 27 mm
305810-0110-810
Sterilizable cap, 49 mm
305810-9007-000 2x sterilizable caps, 49 mm
305810-0111-810
Sterilizable cap, 25 mm
305810-9013-000 6x sterilizable caps, 25 mm
305810-0112-810
Sterilizable cap, 62 mm
305810-9014-000 2x sterilizable caps, 62 mm
305935-0303-810 Sterilizable sleeve
305935-8022-000 2x sterilizable sleeves
305935-0060-810 Sterilizable cap, 33 mm
305935-8041-000 6x sterilizable caps, 33 mm
305935-0902-810 Sterilizable handgrip cover
305935-8083-000 4x sterilizable handgrip covers
1.2. Target group The present Instructions for Use are intended for physicians, medical and technical staff and nurses who prepare the product for use with the device after receiving appropriate instruction. The intended usage site for the product is operating rooms in clinics and hospitals. It is the duty of the equipment owner/operator to train and instruct all operating personnel.
1.3. Intended use The products are used to cover medical equipment to provide a barrier against cross-contamination in various clinical settings.
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EN
1.4. Normal use The reprocessable products (asepsis) e.g. knobs, grips are used to cover the necessary equipment during a surgical procedure. According to the intended use, they are used during operations to prevent a contamination of the sterile operation staff by touching the non-sterile control units from the operating microscope. They are provided non-sterile and shall be reprocessed properly according to the IFU prior to use by the customer.
1.5. Indications Information about the intended medical indication, contraindications and the intended patient population are shown in the table below. Intended medical indication Discipline:
Ophthalmic surgery, microsurgery (including but not limited to neuro-, spine-, ear-, nose-, throat- and dental surgery)
Indication for use:
Any surgical indication in the defined disciplines
Contraindication:
Provided that the reprocessable products (asepsis) are used within their indication, there are no known contraindications.
Intended patient population: No restriction Age:
No restriction
Gender:
All
1.6. General Terms and Definitions CZM DI water
CDM
Carl Zeiss Meditec AG Deionized water (demineralized, low bacteria, max. 10 bacteria/ml, as well as low endotoxin contaminated, max. 0.25 endotoxin units/ml), according to the requirements of EN 285 cleaning and disinfection machine
Material Compatibility Before performing pre-cleaning, machine or manual cleaning procedures make sure that the listed substances are not ingredients of the cleaning or disinfecting detergent: • organic, mineral, and oxidizing acids (minimum admitted pH-value 2) • strong lyes (maximum admitted pH-value 12, neutral/enzymatic cleaner recommended) • organic solvents (for example: acetone, ether, alcohol, benzine) • oxidizing agents (for example: peroxide) • halogens (chlorine, jodine, bromine) • aromatic, halogenated hydrocarbons For manual removal of impurities during pre-treatment and cleaning processes only use a soft brush or a damp lint-free cloth. Do not use metal brushes, hard brushes or steel wool for cleaning. Pay attention to the instructions of the cleaning and disinfecting detergent manufacturer regarding concentration and soaking time. Only use freshly prepared solutions. The cleaning and disinfecting detergents shall possess a fundamentally approved efficiency (for example FDA accepted or CE marking), be suitable for the disinfecting of the product and be compatible with the product itself.
1.7. General Prerequisites CAUTION! The products must be completely reprocessed before use. The products must not be used if damaged. Use cleaning and disinfection machines that meet the requirements of ISO 15883-1. Service and inspect these cleaning and disinfection machines regularly. Fill the cleaning and disinfection machines so that all the contents are fully rinsed through and cleaned. There must be no "rinsing blind spots". • When pre-treating, do not use fixing temperatures in excess of 45 °C. !
• • • • • 2
• Follow all the cleaning and disinfecting detergent manufacturer’s application specifications regarding temperature, concentration, and contact time. • Adhere to national statutory regulations, national and international standards and directives, and the infection control practices that are in place at your institution for reprocessing. • Note that the optimum and most reliable reprocessing results are achieved using automated cleaning and disinfection with subsequent steam sterilization using the fractionated vacuum procedure. • Ensure that the sterile components fit tightly on the devices.
EN
2. Responsibility and obligations of the operator 2.1. Reprocessing personnel CAUTION! ! In many countries, the qualifications required by personnel responsible for the reprocessing of medical products are regulated by law. In any event, the reprocessing of medical products must always fall under the responsibility of qualified personnel who have the necessary knowledge and expertise. This knowledge and expertise can be acquired by completing further training in this field or as a result of completing a dedicated qualification with practical experience, supplemented by appropriate further training measures, where required. US Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
2.2. Notification of the manufacturer and authorities If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report this serious incident to the manufacturer of the medical product. In the European Union, the operator must report this serious incident to the competent authority in his/her country.
2.3. Assembly and application information 1. 2. 3. 4. 5. 6. 7.
Reprocess the product completely (even if it is brand new) prior to each use, see “Reprocessing Instructions” (G-30-1560). Only touch the product with sterile gloves. CAUTION! Risk of infection due to damaged product! Perform a visual inspection of the product prior to each use. Damaged products must not be used. Make sure that the control or operating element of the surgical microscope that is to be covered by the product is clean and dry. Slide the product onto the control or operating element. Make sure that the product is sitting firmly, does not slip out of position and allows the covered control or operating element to be used without any hindrance. Read and observe the instructions for use of the device on which the product is being used.
2.4. Ambient conditions • The product must only be operated, transported and stored in an environment that is dry and sheltered from direct sunlight.
2.5. Expected useful life Provided that the reprocessing instructions are followed rigorously, the expected useful life of the product is limited to 250 cycles (normal use and sterilization), or two years.
3. Pre-Treatment 3.1. Procedure 1. 2.
Remove coarse impurities immediately after use, within 2 hours at most, as described below. Remove loose dirt with running water of less than 35 °C of at least drinking water quality or a disinfectant solution. For manual removal of impurities use a soft brush or a damp, lint-free cloth.
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4. Reprocessing 4.1. General The following disinfection steps within this instruction are not applicable for the treatment in the US. Specific instructions for the US are mentioned in chapter 4.3 and 4.5. The reprocessing procedure for the product described in this document consists of the following steps: • Pre-treating within 2 hours after use • Manual cleaning and disinfection or automated cleaning and disinfection • Sterilization. The specified procedures for manual cleaning and disinfection, automated cleaning and thermal disinfection, and steam sterilization have been validated for effectiveness. It is the operator’s responsibility to introduce, document, implement and maintain a validated reprocessing procedure.
4.2. Manual Cleaning and Disinfection (not for USA) Overview Stage
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Work Step
I
Cleaning
II
Intermediate rinse
III
Disinfection
IV
Final rinse
V
Drying
Temperature Time (°C/°F) (min) Room 20 temperature
Water Quality Drinking water
Room temperature (cold) Room temperature
1
Drinking water
5
-
Cleaning Solution Cleaning solution e.g. min. 0.5% "neodisher® MediZym" (in accordance with manufacturer's specifications) -
Disinfectant solution (undiluted), e.g. "Cidex OPA" (Johnson & Johnson) -
Room 1 DI water temperature (cold) Dry the product using a soft, lint-free wipe. Use medical-quality filtered compressed air (pmax = 0.5 bar) to dry the areas you cannot reach with the wipe.
Procedure 1. Fully immerse the product in a cleaning solution for 20 minutes. Make sure that the cleaning solution reaches all accessible surfaces. 2. While the product soaks in the solution, use a soft brush or a lint-free cloth to remove all visible residue from its exterior surfaces. 3. Use a soft brush or a lint-free cloth to clean the entire surface under warm, running water (at least drinking water quality) for at least one minute until residues are no longer visible. 4. Allow water to drip off for a sufficient length of time. 5. Fully immerse the product in the disinfectant solution for 5 minutes. Make sure that the disinfectant reaches all accessible surfaces. 6. Remove all adherent air bubbles from the product's surfaces. 7. Then completely immerse the components in cold, demineralized and deionized water or in water of a higher quality (e.g. drinking water purified by reverse osmosis) for one minute. 8. Allow water to drip off for a sufficient length of time. 9. Dry the product using a soft, lint-free cloth. 10. Use medical-quality filtered compressed air (pmax = 0.5 bar) to dry the areas you cannot reach with the wipe. 11. After drying, visually inspect the product in a well-lit area and make sure it is completely dry, undamaged and free of visible residues. Use a magnifying glass for the visual inspection. 12. Repeat the cleaning and disinfection process if necessary.
4.3. Manual Cleaning (only valid for USA)
EN
Overview Stage
Work Step
I
Cleaning
II
Intermediate rinse
III
Final rinse
IV
Drying
Temperature Time (°C/°F) (min) Room 20 temperature
Water Quality Drinking water
Cleaning Solution Cleaning solution e.g. min. 0.5% "neodisher® MediZym" (in accordance with manufacturer's specifications) -
Room 1 Drinking temperature water (cold) Room 1 DI water temperature (cold) Dry the product using a soft, lint-free wipe. Use medical-quality filtered compressed air (pmax = 0.5 bar) to dry the areas you cannot reach with the wipe.
Procedure 1. Fully immerse the product in cleaning solution prepared according with the cleaning agent manufacturer’s specifications solution 20 minutes. Make sure that the cleaning solution reaches all accessible surfaces. 2. While the product soaks in the solution, use a soft wipe or suitable brush to remove all visible residue from its exterior surfaces. 3. Fully rinse all accessible surfaces three times for at least one (1) minute each. Use fresh water for each rinse. 4. Fully rinse all accessible surfaces three times for at least one (1) minute each. Use DI-Water for each rinse. 5. Allow water to drip off for a sufficient length of time. 6. Dry the product using a soft, lint-free wipe. 7. Use medical-quality filtered compressed air (pmax = 0.5 bar) to dry the areas you cannot reach with the wipe. 8. After drying, visually inspect the product in a well-lit area and make sure it is completely dry, undamaged and free of visible residues. Use a magnifying glass for the visual inspection. 9. Repeat the cleaning process if necessary.
4.4. Automated cleaning and disinfecting (not for USA) Overview Stage
Work Step
I
Pre-rinsing
Temperature Time (°C/°F) (min) < 25/77 2
II
Cleaning
55/131
III
Rinse I
IV
Rinse II
V
Thermal disinfection
according 1 with the CDM standard cycle according 1 with the CDM standard cycle > 90/194 1
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Water Quality Drinking Water Drinking water DI water
Cleaning Solution Cleaner, e.g. 0.5% neodisher® MediZym -
DI water
-
DI water
A0 value > 600
5
Stage
EN VI
Work Step Drying
Temperature Time Water (°C/°F) (min) Quality according according with the CDM with the standard cycle CDM standard cycle
Cleaning Solution -
Automated reprocessing can cause plastic components to change their color. This does not affect the performance of the product. Procedure 1. Load the cleaning and disinfection machine according to the validated loading plan, and observe the manufacturer's specifications and instructions for use for the cleaning/disinfection machine and for the cleaning agent. 2. When loading, take care to avoid creating rinsing blind spots. 3. Start the cleaning/disinfection cycle in accordance with the manufacturer’s instructions and instructions for use for the cleaning/disinfection machine. 4. Remove the product from the cleaning/disinfection machine at the end of the cleaning cycle. 5. After drying, visually inspect the product in a well-lit area and make sure it is completely dry, undamaged and free of visible residues. Use a magnifying glass for the visual inspection. 6. Repeat the cleaning and disinfection process if necessary. General suitability of the devices for effective machine cleaning and disinfection was certified by an independent accredited test laboratory using the G 7836 CD disinfector (thermal disinfection, Miele & Cie. GmbH & Co., Guetersloh) and the cleaning agent Neodisher Medizym (Dr. Weigert GmbH & Co. KG, Hamburg). The method described was used.
4.5. Automated cleaning (only valid for USA) Overview Stage I
Pre-rinsing
Temperature Time (°C/°F) (min) < 25/77 2
II
Cleaning
55/131
III
Rinse I
IV
Rinse II
V
Thermal disinfection Drying
according 1 with the CDM standard cycle according 1 with the CDM standard cycle > 90/194 1
VI
Work Step
10
Water Quality Drinking Water Drinking water Drinking water
Cleaning Solution Cleaner, e.g. 0.5% neodisher® MediZym -
DI water
-
DI water
A0 value > 600
according according with the CDM with the standard cycle CDM standard cycle
-
Automated reprocessing can cause plastic components to change their color. This does not affect the performance of the product. Procedure 1. Load the cleaning and disinfection machine according to the validated loading plan, and observe the manufacturer's specifications and instructions for use for the cleaning/disinfection machine and for the cleaning agent. 2. When loading, take care to avoid creating rinsing blind spots. 6
3.
Start the cleaning/disinfection cycle in accordance with the manufacturer’s instructions and instructions for use for the cleaning/disinfection machine. Remove the product from the cleaning/disinfection machine at the end of the cleaning cycle. After drying, visually inspect the product in a well-lit area and make sure it is completely dry, undamaged and free of visible residues. Use a magnifying glass for the visual inspection. 6. Repeat the cleaning process if necessary. General suitability of the devices for effective machine cleaning and disinfection was certified by an independent accredited test laboratory using the G 7836 CD disinfector (thermal disinfection, Miele & Cie. GmbH & Co., Guetersloh) and the cleaning agent Neodisher Medizym (Dr. Weigert GmbH & Co. KG, Hamburg). The method described was used.
EN
4. 5.
5. Sterilization 5.1. Steam sterilization parameters The user is responsible for ensuring that the sterilizer used fulfills the following sterilization parameters: Cycle type Temperature Temperature for US Holding time Holding time for US Pulse Drying time
Fractionated vacuum process 134 °C (273 °F) 132 °C (270 °F) 3 minutes (effective sterilization time) 4 minutes (effective sterilization time) 4 At least 30 minutes
Procedure 1. Validated sterile barrier systems: Pack the product in sterilization pouches. Note for US: Use only FDA cleared pouches. 2. Load the sterilizer according to the validated loading plan, and observe the manufacturer's specifications and instructions for use for the sterilizer. 3. Start the sterilization cycle in accordance with the manufacturer’s instructions and instruction for use for the sterilizer. Use validated parameters for steam sterilization specified above. 4. Remove the product from the sterilizer. 5. Ensure that the product remains sterile after reprocessing. General suitability of the devices for effective steam sterilization was certified by an independent, accredited testing lab using the sterilizer Euro-Selectomat (MMM Muenchener Medizin Mechanik GmbH, Planneg) for the fractioned vacuum method. The method described was used.
5.2. Reusability ! CAUTION! You may re-use all reprocessable products (asepsis) up to 250 times or 2 years, whichever applies first - provided proper care is taken and they remain clean and undamaged. This was verified using an alkaline cleaning agent. Furthermore, there are currently no test results available. Slight changes in color may occur, but do not impair the function. The user is solely responsible for each use beyond the defined sterilization cycles or use of damaged or dirty reprocessable products. Failure to observe these instructions nullifies liability.
6. Disposal Incorrect disposal contaminates the environment! If the product is improperly disposed of via domestic waste or via municipal waste disposal services, pollutants will enter the environment. • Do not dispose of the product as normal municipal waste. • For disposal, also observe the legal provisions applicable in your country and the hygiene regulations of the doctor’s clinic or hospital. Contamination due to incorrect disposal! If the product is not reprocessed prior to disposal, germs will enter the environment. • Be sure to reprocess the product completely before disposing if it.
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7. Symbols Symbol Description
Symbol Description
Symbol Description
Product Catalog number
Serial No.
CE marking
Packaging Catalog number
CE marking
Date of manufacture
Manufacturer
Keep dry
Batch code
Number of packaging units
Keep away from sunlight Observe the Instructions for Use
Non-sterile
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The product may only be used by a physician or by another person on behalf of a physician. MD labeling (Medical Device) UDI labeling