3 Pages
Preview
Page 1
RESIGHT metal tray for resterilizable products These Instructions for Use apply to the RESIGHT metal tray (material number 302721-9250-000) Subject to change in design and scope of delivery as well as technical development. Printed in Germany. © Carl Zeiss Meditec AG 2015
1. Safety notes
3.2 Pretreating contaminated lens supports, aspheric lenses, and Asepsis Caps NOTE!
WARNING! Indicates a hazard which can lead to death or severe injury if it is not prevented.
To prevent damage to the surfaces, do not use metal brushes, steel wool, rigid brushes, or aggressive substances when cleaning the lens holder, the aspheric lenses, and the Asepsis Caps.
CAUTION!
Please note that the disinfectant used during pretreatment serves only for decontamination purposes to protect persons against blood-borne pathogens. It is no substitute for the subsequent disinfection.
Indicates a hazard that can cause moderate injuries if it is not avoided. NOTE! Indicates a hazard which can cause slight injuries and damage to material if not prevented.
Clean the lens holder, the aspheric lenses, and the Asepsis Caps as follows: • Place the components in a pH-neutral enzymatic cleaning agent with surfactants (consisting of no more than 5% surfactants) •
Place the components in said cleaning agent as specified for the effectiveness of the cleaning agent, at least for 20 minutes at room temperature.
•
Turn the lens revolver 10 times and move all joints to moisten all pivoting joints and surfaces.
•
Rinse the components under hot water (at least drinking water quality) for one minute.
Additional information 1.1 Intended use The RESIGHT metal tray is used to store medical accessories in a defined position during steam sterilization to ensure that reproducible sterilization results are obtained.
4. Machine cleaning and disinfecting
1.2 Proper use
4.1 Auxiliaries for machine cleaning and disinfecting
The product is intended for use in hospitals, clinics or other human medical institutions. It is used to prepare the following resterilizable RESIGHT 500 and RESIGHT 700 components for sterilization:
The following cleaning agents and disinfectants are required for the cleaning/disinfecting device and for disinfection:
–
Lens support (302721-9060-000, 302721-9070-000)
–
–
Aspheric lenses (302721-9100-000, 302721-9080-000)
Cleaning agents: When selecting the cleaning agent, ensure that:
–
Asepsis Caps (305810-9001-000)
–
It is suitable for cleaning the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps made of metal and plastic
–
It has either a neutral or alkaline pH value
–
An additional, suitable disinfectant with certified effectiveness (e.g. DGHM or FDA approval or CE label) is used, if no thermal disinfection is applied, and that the disinfectant is compatible with the cleaning agent used
–
The chemicals used are compatible with the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps (see the chapter on "Material durability").
The sterilized components can be stored and transported in the sterile RESIGHT metal tray. Clean, disinfect, and sterilize the RESIGHT metal tray, lens holder, aspheric lenses, and Asepsis Caps prior to disposal. 1.3 Target group This manual is intended for physicians, nurses and medical and/or technical staff who clean, disinfect and sterilize the product.
2. General provisions
–
The RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps must be cleaned, disinfected and sterilized before each use. This applies in particular to the first use following delivery, as all components are delivered non-sterile (clean and disinfect after removing the protective transport packaging; sterilize after loading the RESIGHT metal tray).
•
Please note that the following sterilization methods are not permitted: –
Flash sterilization
–
Hot air
–
Radiation
–
Formaldehyde or ethylene oxide
–
Plasma
As you are responsible for the sterility of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps, please observe the following general guidelines during use: – –
•
Make sure that the devices used (cleaning/disinfecting device, sterilizer) are regularly checked and serviced.
EU customers: Classification as semi-critical B according to the RKI guideline (Robert Koch Institute) is recommended. The final classification must be made by the user, taking into account the actual field of use.
The disinfecting device has a tested effectiveness
–
A tested program is used for thermal disinfection if possible
–
The program used must be suitable for the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps, and must provide sufficient rinsing cycles.
–
Post-rinsing is done only with fresh solutions with suitable quality for the process and filtered air must be used for drying.
–
The cleaning/disinfecting device must be serviced and checked at regular intervals.
It is absolutely necessary that the concentrations specified by the manufacturer of the cleaning agent and, if necessary, disinfectant be adhered to. EU customers: If possible, a tested program for thermal disinfection (A0 value > 3000 or, if older devices are used, at least 10 min. at 93°C / 199°F) should be used (chemical disinfection risks leaving residual disinfectant on the RESIGHT metal tray, lens holder, aspheric lenses, and Asepsis Caps). 4.2 Machine cleaning and disinfection of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps CAUTION! •
Make sure that the validated parameters are complied with in each cycle.
Also observe the legal provisions applicable in your country and the hygiene regulations of the doctor's office and hospital. This is, in particular, applicable to varying specifications with regard to efficient prion inactivation.
–
The cleaning with a cleaning/disinfecting device must comply with the validated parameters described in Chapter 4.2. EU customers: A cleaning/disinfecting machine of the type Miele G 78823 was used for validation.
Proper cleaning and disinfection are vital prerequisites for effective sterilization. If possible, a cleaning/disinfecting device should be used for cleaning and disinfecting. Due to the reduced effectiveness and reproducibility, a manual method should only be used if a cleaning/disinfecting device is not available. We recommend using the cleaning, disinfecting, and sterilizing methods validated by ZEISS as described here in the Instructions for Use. •
Cleaning/disinfecting device: When selecting the cleaning/disinfecting device, ensure that:
Cleaning of the lens support, aspheric lenses, and Asepsis Caps is allowed only in the RESIGHT metal tray.
•
Place the components in the RESIGHT metal tray.
•
Put the RESIGHT metal tray in the cleaning and disinfection machine.
•
Rinse the components with water (at least drinking water quality).
•
Clean the components with a neutral or alkaline cleaning agent.
•
When using an alkaline cleaning agent, neutralize the components with water having at least drinking water quality and a neutralizer.
•
Remove any loose dirt from the lens holder, the aspheric lenses, and the Asepsis Caps immediately after use (not later than within 2 hours). Use a moist, lint-free cloth, a soft brush, a wipe, or a pHneutral enzymatic cleaning agent comparable to the cleaning agent in 3.2 to remove the contaminants and prevent strong desiccation. This step is usually carried out in the operating room.
Rinse the components with water (at least drinking water quality). Using demineralized and deionized water for the last rinse cycle prior of the thermal disinfection may prolong the service life of the components because it removes tap water residues which might react with the components under the influence of heat.
•
Perform thermal disinfection at 93°C (+5°C, -0°C) for ten minutes, using demineralized and deionized water or water with a higher quality (e.g., drinking water purified by reverse osmosis).
NOTE!
•
Let the components entirely dry at the air (at least 10 minutes) or dry the components with purified compressed air.
•
Verify that the components are completely dry after completion of the cleaning/disinfection cycle.
•
Verify that any residual cleaning agents and disinfectants have been removed from the components after completion of the cleaning and disinfection cycle (if necessary, use an appropriate residue indicator test or a suitable indicator paper which is recommended by the manufacturer of the cleaning and disinfecting agent).
3. Pre-cleaning
The RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps can be damaged during pretreatment if not handled properly. •
Be careful not to scratch any of the components during the entire preparation process.
•
Never use a brush or abrasive agents to clean the components, rather a lint-free cloth.
3.1 Aides for pretreatment The following cleaning agents (not included in the scope of delivery) are required for pre-cleaning: –
Water (drinking water quality, at the least)
–
Cleaning solution which
–
–
does not contain any aldehyde (this would set any blood contaminants),
–
has a tested effectiveness (e.g., DGHM or FDA approval or CE marking),
–
is suitable for cleaning the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps, and compatible with the components (see "Material durability" in section 14)
Soft brush or clean, soft cloth
EU customers: The agents used for validation are the cleaning agent Sekumantic Multiclean (0.7% V/V) and the neutralizer Sekumantic FNP (0,1% V/V).
5. Manual cleaning and disinfection If possible, a cleaning/disinfecting device should be used for cleaning and disinfecting. Due to the reduced effectiveness and reproducibility, a manual method should only be used if a cleaning/disinfecting device is not available.
Page 2
5.1 Auxiliaries for manual cleaning and disinfection The following cleaning and disinfection means are required for manual cleaning and disinfection. When selecting the cleaning agents and disinfectants, ensure that: –
They are suitable for cleaning and/or disinfecting the RESIGHT metal tray, lens holder, aspheric lenses, and Asepsis Caps
–
You use a disinfectant with tested effectiveness (e.g., DGHM or FDA approval or CE marking) and that this disinfectant is compatible with the cleaning agent used
–
The chemicals used are compatible with the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps (see Chapter 14 "Material durability").
8. Packing for sterilization Once set up, the RESIGHT metal tray must be packed for sterilization into a container suitable for steam sterilization or into other packaging material with a sterile barrier (permeable for air elimination and steam penetration suitable for sterilization). This protects the lens support, aspheric lenses, and Asepsis Caps during sterilization, allows the steam to penetrate and the air to escape. Pockets of air can negate the sterilization. 8.1 Variant 1 - Packing components individually •
Pack the lens support (1), the aspheric lenses (2), and the Asepsis Caps (3) individually in packaging suitable for steam sterilization and seal them accordingly.
If possible, combined cleaning and disinfecting agents should not be used. Combined cleaning and disinfecting agents can only be used in cases of very low contamination (no visible contaminants). It is absolutely necessary that the concentrations and exposure times specified by the manufacturer of the cleaning agent and, if necessary, disinfectant are kept. Only use fresh solutions of a quality suitable for the process and filtered air for drying. 5.2 Manual cleaning of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps Do not use metal brushes or steel wool, etc., to clean the devices, as this may scratch the surfaces. •
Place the components into a solution consisting of no more than 5% surfactants and enzymes for 20 minutes at room temperature.
•
Use a medium-hard toothbrush 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.
•
Brush and rinse the components under cold demineralized and deionized water or water with a higher quality (e.g., drinking water purified by reverse osmosis) for at least one minute.
1
2
3
8.2 Variant 2 - Pack the RESIGHT metal tray in a container with a sterile barrier •
Place the lens support (1), the Asepsis Caps (2), and the aspheric lenses (3) in the marked compartments of the RESIGHT metal tray.
•
Turn the aspheric lenses (3) to push them into the marked silicone receptacles.
•
Close the cover (4) of the RESIGHT metal tray.
1
2
4
EU customers: A 1% MediZym solution (V/V) was used for validation. 5.3 Manual disinfection of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps
3
To prevent damage to the materials, do not dry the components in an oven, microwave, drying oven, etc. •
Place the components into a solution consisting of no more than 5% surfactants and enzymes for 30 minutes at room temperature.
•
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.
•
Subsequently, wipe the surface of the components with a non-fluffy cloth.
•
Verify that any residual cleaning and disinfecting agents have been removed from the components after completion of the cleaning / disinfection cycle. If necessary, use an appropriate residue indicator strip or a suitable indicator paper which is recommended according to the operating instructions issued by the manufacturer of the cleaning and disinfecting agent.
•
Let the components dry at the air or dry the components with purified compressed air.
•
Verify that the components are completely dry after completion of the cleaning/disinfection cycle.
1
EU customers: A 2.5% Sekusept Plus solution (V/V) was used for validation.
3
6. Inspection
2
The cleaning, disinfection, and sterilization of the lens support, aspheric lenses, and Asepsis Caps of the RESIGHT metal tray have been validated as follows: –
Lens holder: 200 times
–
Aspheric lenses: 200 times
–
Asepsis Caps: 250 times
–
RESIGHT metal tray: 500 times
2
•
Before sterilizing, pack the RESIGHT metal tray with the components into packaging suitable for steam sterilization and seal accordingly. The sterilization container and the filter must comply with ISO 11607-1:2006.
9. Sterilization
CAUTION!
CAUTION! As you are responsible for the sterility of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps, please observe the following general guidelines during use: – Make sure that the sterilizer is regularly checked and maintained.
•
As you are responsible for the sterility of the lens support, aspheric lenses, and Asepsis Caps, make sure to adhere to the maximum number of sterilization cycles.
•
Check all components after cleaning or cleaning/disinfection for corrosion, damaged surfaces, chipping and contamination (in particular inside).
–
Make sure that the validated parameters are complied with in each cycle.
•
Eliminate damaged components and dispose of such components according to the applicable local and national legal regulations.
–
For sterilization, we recommend using the method validated by ZEISS described below.
•
Components which are still contaminated must be cleaned and disinfected once more.
9.1 Steam sterilization of single components – Fractionated vacuum method or gravitation method (with sufficient drying)
7. Maintenance
–
Steam sterilizer according to EN 13060:2014, EN 285:2009
–
The steam sterilizer should be validated according to ISO 17665-1:2006.
Do not use any precision machine lubricant on the RESIGHT metal tray.
–
Sterilization temperatures 132°C - 138°C (270°F - 280°F; in addition, tolerance according to ISO 17665-1:2006)
–
Fractionated vacuum method: Sterilization time at least 4 min. at 132°C (270°F) or Sterilization time at least 3 min. at 134°C (273°F) or
–
Gravitation method: Sterilization time at least 10 min. at 132°C (270°F) at maximum 138°C (280°F)
Lubricating the lens support To be able to move and turn the lens support smoothly, lubricate the hinges regularly. Aesculap STERILITi® oil spray has been validated for this purpose. •
Dry the completely cleaned and disinfected lens support.
•
Spray some STERILITi® oil spray onto the hinges of the lens support.
•
Move the oiled hinges several times.
•
Remove any excess oil using a lint-free cloth.
A longer sterilization time is possible, but may have a negative effect on the service life of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps. 9.2 Steam sterilization with RESIGHT metal tray –
Fractionated vacuum method or gravitation method (with sufficient drying)
–
Steam sterilizer according to EN 13060:2014, EN 285:2009
–
The steam sterilizer should be validated according to ISO 17665-1:2006
–
Sterilization temperatures 132°C - 138°C (270°F - 280°F; in addition tolerance according to ISO 17665-1:2006)
–
Fractionated vacuum method:
Page 3
Sterilization time at least 4 min. at 132°C (270°F) or Sterilization time at least 3 min. at 134°C (273°F) or –
Gravitation method: Sterilization time at least 10 min. at 132°C (270°F) at maximum 138°C (280°F)
–
Never clean the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps with metallic brushes or steel wool.
•
The use of ultrasound is not permitted either.
•
Never expose the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps to temperatures above 141°C (286°F).
A longer sterilization time is possible, but may have a negative effect on the service life of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps. 9.3 Manual sterilization of the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps
Aromatic/halogenated hydrocarbons
•
15. Technical specifications RESIGHT metal tray:
•
Use one of the steam sterilization methods (ISO 17665-1:2006) mentioned above to sterilize the components.
–
Dimensions in mm: 177 x 181 x 87 (length x width x height)
•
Do not expose the RESIGHT metal tray to temperatures above 141°C (286°F)!
–
Weight: 0.54 kg
•
Allow the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps to cool down to ambient temperature following sterilization and before reuse or disposal.
–
System label
The Asepsis Caps for the focusing knobs provided by ZEISS can also be sterilized using the procedure described in the manual "Preparing resterilizable products" (G-30-1560, G-30-1690, G-30-1691). The corresponding Instructions for Use are included with the Asepsis Caps.
Manufacturing address Manufacturer symbol Serial number Device name Material number
Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena, Germany RESIGHT metal tray 5
10. Storage CAUTION! Patient contamination! If the RESIGHT metal tray is stored too long, the packing may no longer maintain its function as a sterile barrier and germs may reach sterile parts. •
Check the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps after cleaning or cleaning/disinfecting for corrosion, damaged surfaces, chipping and contamination (in particular inside).
•
We therefore recommend that you write the respective sterilization date onto the container(s) or external sterile barrier and define the maximum storage time. Adhere to local regulations if they differ from this suggestion. The customer is responsible for the labeling. CAUTION!
Patient contamination! If the RESIGHT metal tray enters the area of sterile goods without having been sterilized, or if the user fails to realize that the RESIGHT metal tray has not been sterilized, there is a risk of contamination to the patient. •
We therefore recommend that you write the respective sterilization date on the container(s) or external sterile barrier and define the maximum storage time. Follow the local regulations if they are different from the proposal made.
•
Keep the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps in a clean, dry, and dark place following sterilization.
•
Protect the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps from direct sunlight.
11. Use in the sterile area CAUTION! Contamination of the lens support, aspheric lenses and Asepsis Caps. •
Touch the RESIGHT metal tray and its contents only when you are sterile and only in the sterile OR area.
•
Have a non-sterile person open and give you the packaging.
•
Ensure that you are sterile when you remove the RESIGHT metal tray or remove the cover of the RESIGHT metal tray.
•
Remove the sterilized components and mount them on the system. Make sure that the sterile components are securely positioned.
•
Set the RESIGHT metal tray aside.
•
Repeat the preparation procedure after using the sterile components. Please read the corresponding chapter in these Instructions for Use.
12. Reusability The RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps can be reused, provided they are treated with the appropriate care and they are undamaged and clean. CAUTION! The user is responsible for using damaged and/or contaminated components. Failure to comply with this requirement excludes any liability.
13. Disposal NOTE! •
Clean, disinfect and sterilize the RESIGHT metal tray, lens support, aspheric lenses, and Asepsis Caps completely prior to disposal.
•
For disposal, also observe the legal provisions applicable in your country and the hygiene regulations of the doctor's office or hospital.
14. Material resistance •
Do not use any cleaning and disinfecting agent that contains the following ingredients: –
Organic, mineral and oxidizing acids (minimum permissible pH value: 5.5)
–
Strong lyes (maximum permissible pH value: 11 at application temperature)
–
Organic solvents (e.g., alcohol, ether, ketone, benzine)
–
Oxidants (e.g. hydrogen peroxide)
–
Halogens (chlorine, iodine, bromine)
Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany
Fax: +49 (0) 7364-20 48 23 E-mail: [email protected] Internet: www.zeiss.com/med
G-30-1770-en Issue 8.1 2015-11-16