Reprocessing Guide
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Hygienic Reprocessing
HEINE Classic+ and Modular+ Laryngoscope blades As described in the instruction manual med 4797 (Classic+) and 1302 (Modular+), the following directions must always be adhered to. General warning and safety information: WARNING! This symbol draws attention to a potentially dangerous situation. Non-observance can result in mild to moderate injuries. (Background color yellow; foreground color black). NOTE! This symbol is used for information regarding installation, operation, maintenance or repairs that are important but are not associated with dangers.
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Reprocessing limit (service life)
The following instructions must be incorporated into the internal regulations of hospitals and clinics, for instance with regard to the implementation of national guidelines, recommendations, standards and laws. National guidelines, recommendations (e.g. with regard to CJD / vCJD), standards and laws must furthermore be observed and implemented. Devices that are suspected to have come into contact with the pathogens of Creutzfeld-Jakob disease (CJD) or its variants may not be reprocessed under any circumstances. Hygienically reprocess any contact surfaces and otherwise contaminated surfaces after each use. The described cleaning and disinfection measures do not replace the specific rules applicable for the establishment. Observe the instructions of the manufacturer of the reprocessing media. HEINE Optotechnik only recommends the below mentioned agents and processes. When using other disinfectants: These must be bactericidal, (including mycobacteria), fungicidal and virucidal. The disinfection, according to FDA recommendations in the United States, must be at least a highlevel disinfection or it must take place after sterilization. The preparation is to be carried out by persons with adequate hygienic expertise. Check the device for contaminates before use. If necessary, clean the device or dispose of it in the event of non-removable contamination. During reassembly, make sure that non-sterile parts (inserts, base caps, batteries, etc.) do not recontaminate already sterile parts (blade, handle / head) Following each cleaning, disinfection or sterilization, check that the laryngoscope blade is functioning properly. After reprocessing and before use, carry out a functional check for any damages (sharp edges, ruptures). A spray disinfection is not permitted! (lack of effectiveness, health hazards and / or damage to the product) In order to avoid surface rust, the blade, the handle shell and the handle head may not be processed with inferior instruments. No ultrasonic reprocessing. The optical fibres could be damaged beyond repair. The Hygienic reprocessing only has a minor influence on the product life as this is determined mainly by wear and tear during use. Periodically check the integrity of the device and that the illumination is sufficient!
Regulations regarding reprocessing:
The following instructions must be adhered to based on national standards, laws and guidelines. Classification according to KRINKO Spaulding Classification USA At the place of use
semicritical B semicritical Remove coarse contamination promptly after use with a damp disposable cloth by wiping to prevent the drying of any residues. Dirt that has dried on the device makes the cleaning more difficult and may also cause material changes.
Storage and transport
Reprocessing should take place as soon as possible following use.
Cleaning preparations
The instrument must be taken apart for reprocessing. The blade must also be taken off the laryngoscope handle. Modular+ Blades must be dismounted for reprocessing: - Mac: Grasp the blade with one hand and push out the optical fibre module with the thumb of the other hand. - Miller: Grasp the blade with one hand, press the optical fiber module at the top with the thumb of your other hand out of the lock and pull it out of the socket. Equipment Cleaning agent: enzymatic or neutral to mildly alkaline (e.g. Neodisher® MediClean) Soft plastic brush: • Round with a diameter of 0.5 cm - 3 cm and length of min. 3 cm • Flat brush Clean container size: at least 30 x 30 x 10 cm Warm (30 - 40 °C) chlorine-free or demineralized water Cloth
Manual cleaning
Implementation The blades, blade body or optical fiber module should soak for 1 min. submerged in the cleaning solution (30 - 40 °C). After this, all surfaces should be brushed with a flat brush at least 3 times (immersed in cleaning solution).The notches, recesses and cavities should be brushed with a round or flat plastic brush at least 3 times (brush diameter depending on accessibility). The area around the locking mechanism should be brushed with a round plastic brush from all directions at least 3 times.
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Then, rinse the blade or its modules with running demineralized water for at least 1 min. Ensure thorough rinsing of recesses and corners. Allow at least 1 min to drain on a towel.
Manual cleaning (continued)
Visual inspection The laryngoscope blades should be checked for visible contaminants or abrasion and should be cleaned again if necessary or disposed of if the contaminants cannot be removed.
Manual disinfection
Equipment Disinfection agents for immersive disinfection (compatible with cleaning agents) Disinfectant agent Quaternary ammonium compounds (e.g. neodisher® Septo MED or agent ortho-phthalaldehyde (E.g. Cidex® OPA) Low-germ demineralized water Cloth Disinfection container Size: at least 30 x 30 x 10 cm Implementation The blades, blade body or optical fiber module should be disinfected by immersion disinfection: Submerge the blade into the disinfectant solution and leave, according to the exposure time stated by the agents’ manufacturer. Avoid any air pockets. If required by the manufacturer of the disinfectant: rinse the blade or the modules with low-germ, demineralized water for at least 5 times and then allow to dry on a towel. If removal of the disinfectant is not required by the manufacturer, place the blade on a clean dry cloth and allow to dry. Equipment Washer/disinfector that conforms to the requirements of DIN EN ISO 15883 or with a validated procedure corresponding to DIN EN ISO 15883 Cleaning agent (enzymatic or alkaline (e.g. Neodisher® MediClean) Neutralising agent if necessary (if specified by the cleaning agent manufacturer) Demineralized water
Mechanical cleaning and disinfection
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Implementation Place the laryngoscope blades topple safe and without touching each other into the cleaning/disinfection unit. The rinse cycle must ensure sufficient removal of any residues. The instructions from the manufacturer of the treatment agents and the cleaning/disinfecting device must be followed.
Mechanical cleaning and disinfection (continued)
For mechanical cleaning and disinfection, a suitable cleaning agent and cleaning programme must be chosen (recommendation: Vario TD programme with disinfection lasting at least 5 min. at 93 °C or an alternative, comparable programme).
Maintenance
No requirements
Checks and functional testing
The laryngoscope blades should be checked for visible contaminants or abrasion and should be cleaned again if necessary or disposed of if the contaminants cannot be removed. The functionality of the item must be checked according to its intended use. This requires the entire device to be assembled.
Packaging
The laryngoscope blades must be packaged individually in double paper/foil sterilization pouches.
Sterilization
Flash autoclaving is not permitted! Parts that are damaged as a result of this procedure are not covered under HEINE's warranty conditions. The drying time depends on a number of parameters. It is the responsibility of the user to determine and validate the drying time. Implementation The laryngoscope blades must be sterilized using one of the following procedures: Fractionated vacuum procedure (3 times): Sterilization temperature: at least 132 °C (max. 134 °C) Application time: at least 3 min. Holding time: at least 3 min. Drying time: at least 20 min.
Storage
The laryngoscope blades should be stored in such a way that they are protected from recontamination, dust and moisture.
Additional information
During reassembly, avoid recontamination of sterile parts (blade and handle shell) by non-sterile parts (battery insert including bottom cap and batteries).
Manufacturer's contact information
See instruction manual or see below
HEINE Optotechnik GmbH & Co. KG • Kientalstr. 7 • 82211 Herrsching • Germany Tel. +49(0)8152/38-0 • Fax +49(0)8152/38-202 • E-Mail: [email protected] •www.heine.com 4/4
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Gravitation procedure (3 times): Sterilization temperature: at least 132 °C (max. 134 °C) Application time: at least 3 min. Holding time: at least 3 min. Drying time: at least 20 min.