Hygienic Reprocessing

General Warning and Safety Information

⚠️ WARNING! This symbol draws attention to a potentially dangerous situation. Non-observance can result in moderate to major injuries.

ℹ️ NOTE! This symbol indicates valuable advice. Notes are important, but not related to hazardous situations.

Instructions on hygienic reprocessing must be adhered to, based on national standards, laws and guidelines. The described reprocessing measures do not replace the specific rules applicable for your institution/ department.

After each use and charging, carry out hygienic reprocessing.

Equipment where there is a suspicion of exposure to Creutzfeld-Jakob disease (CJD) pathogens or variants must not be reprocessed under any circumstances.

Please consider the instructions of the manufacturer for the applied reprocessing media. HEINE Optotechnik GmbH & Co. KG only approves the agents and procedures listed in this instruction.

Hygienic reprocessing is to be carried out by persons with adequate hygienic expertise.

The handle inserts, bottom inserts and rechargeable and dry cell batteries are not suitable for automated reprocessing, immersion disinfection or steam sterilization.

HEINE rechargeable batteries and their bottom inserts are not suitable for reprocessing using a STERRAD procedure.

Before using it again, ensure that the handle is completely dry after reprocessing.

Hold the insert with the contact pointing downwards during wiping to prevent liquid entry. Liquid should not enter the insert during reprocessing because this could damage the device.

In order to avoid recontamination of the processed parts during reassembly, the batteries should remain within the laryngoscope handle insert during reprocessing of the STANDARD handle.

After cleaning, the handle must be rinsed free of residue in order to avoid reactions with subsequent treatment stages/ damage to the materials.

• As long as the product meets the requirements of ISO 7376.
• Periodically check the integrity of the device and that the illumination is sufficient.

Limitations on Reprocessing

As long as the product meets the requirements of ISO 7376.

Periodically check the integrity of the device and that the illumination is sufficient.

Choice of the Reprocessing Procedure

The hygienic classification (Spaulding classification) of the laryngoscope handles, as well as the decision for one of the offered reprocessing procedures, is the responsibility of the user or the qualified person(s) responsible for reprocessing. Internal regulations of your hospital/ institution, national directives, recommendations, standards and laws need to be considered.

For highly infectious cases (previous or following patients) (e. g. in case of a proven existence of a dangerous infectious disease (symptomatic or asymptomatic), the reprocessing guidelines in this document are superseded by processes of your institution / practice-internal regulations, national directives, recommendations, standards and laws.

The laryngoscope insert and the bottom insert, need to be reprocessed as shown in Chapter A.

Choose one of the following reprocessing methods for the handle shell:

Chapter A: Intermediate-level wipes disinfection of the laryngoscope insert and bottom insert

1. Containment and transportation

   Reprocess as soon as possible following use.

2. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Reprocess the handle shell as described in chapter B-G.

3. Manual cleaning and disinfection

   Pay attention that all surfaces are completely moistened for the complete exposure time specified by the disinfectant manufacturer. If necessary, increase the number of wiping procedures and or the number of wipes.

   Avoid liquid entry in the laryngoscope insert and the bottom insert of the laryngoscope handle.

   Equipment

   • Intermediate level disinfection wipes: alcohol and/or quarternary ammonium compounds (e. g. Super Sani-Cloth by PDI) having an EPA-registered claim for activity against Mycobacterium tuberculosis and Hepatitis B.

   Implementation

   • Wipe the laryngoscope insert and bottom insert three times with a fresh wipe.
   • Pay particular attention to recesses, ridges, difficult to access areas.
   • For removing the disinfectant and drying afterwards, follow the instructions provided by the disinfectant manufacturer.

4. Reassembly

   Insert the laryngoscope insert and bottom insert into the handle shell and close it.

5. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing after reprocessing.

6. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

Chapter B: Automated cleaning and disinfection of the handle shell

1. Point of use

   Gross contamination must be removed soon after use, e. g. with a disposable wet wipe or enzymatic pre-cleaner.

2. Containment and transportation

   Reprocess as soon as possible following use.

3. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Clean and disinfect the laryngoscope handle insert and bottom insert as described in Chapter A.

4. Cleaning and disinfection

   If it is required in your institution or your country, you can perform manual cleaning of the handle shell by brushing before automated cleaning and disinfection.

   4.1 Automated cleaning and disinfection

   Equipment

   • Washer/disinfector that conforms to the requirements of ISO 15883 or has a validated procedure corresponding to ISO 15883.
   • Cleaning agent: enzymatic or neutral to mildly alkaline (e. g. CIDEZYME by ASP).
   • Neutralizing agent if specified by the cleaning agent manufacturer.

   Implementation

   • The instructions from the manufacturer of the cleaning agents and the washer/disinfector must be followed.
   • Chose a suitable cleaning agent and cleaning program (according to ISO 15883).
   • Recommendation: A program with disinfection lasting at least 5 min. at 93 °C or an alternative, comparable program.

5. Reassembly

   Insert the laryngoscope insert and bottom insert into the handle shell and close it.

6. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing after reprocessing.

7. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

Chapter C: Manual cleaning (brushing) and high-level manual disinfection (immersion) of the handle shell

1. Point of use

   Gross contamination must be removed soon after use, e. g. with a disposable wet wipe or enzymatic pre-cleaner.

2. Containment and transportation

   Reprocess as soon as possible following use.

3. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Clean and disinfect the laryngoscope handle insert and bottom insert as described in Chapter A.

4. Manual cleaning by brushing

   Equipment

   • Cleaning agent: enzymatic or neutral to mildly alkaline (e. g. CIDEZYME by ASP).
   • Warm (30 - 40 °C) demineralized water, soft plastic brushes.

   Implementation

   • Soak the handle shell for 1 min. submerged in the cleaning solution (30-40 °C).
   • Clean all surfaces of the handle shell by brushing (submerged in the cleaning solution).
   • Pay particular attention to recesses, ridges, difficult to access areas of the snap-in mechanism, below the hinge and the inner surfaces of the handle shell.
   • For removing the cleaning agent and drying afterwards, follow the instructions provided by the manufacturer of the cleaning agent.

5. Manual immersion disinfection

   Equipment

   • High level disinfectant for immersion disinfection (compatible with cleaning agent): Quarternary ammonium compounds (e. g. neodisher Septo MED) or agent ortho-phthalaldehyde (e. g. CidexOPA)

   Implementation

   • Immerse the handle shell in the disinfectant solution as specified by the manufacturer of the disinfectant.
   • Pay particular attention to maintain the specified concentrations, temperatures and the contact times.
   • For removing the disinfectant and drying afterwards, follow the instructions provided by the manufacturer of the disinfectant.

6. Reassembly

   Insert the laryngoscope insert and bottom insert into the handle shell and close it.

7. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing after reprocessing.

8. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

Chapter D: Automated cleaning, disinfection and low temperature sterilization STERRAD / VHP (Steris)

1. Point of use

   Gross contamination must be removed soon after use, e. g. with a disposable wet wipe or enzymatic pre-cleaner.

2. Containment and transportation

   Reprocess as soon as possible following use.

3. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Clean and disinfect the laryngoscope handle insert and bottom insert as described in Chapter A.

4. Cleaning and disinfection of the handle shell

   If it is required in your institution or your country, you can perform manual cleaning of the handle shell by brushing before automated cleaning and disinfection.

   4.1 Automated cleaning and disinfection of the handle shell

   Equipment

   • Washer/disinfector that conforms to the requirements of ISO 15883 or has a validated procedure corresponding to ISO 15883.
   • Cleaning agent: enzymatic or neutral to mildly alkaline (e. g. CIDEZYME by ASP).
   • Neutralizing agent if specified by the cleaning agent manufacturer.

   Implementation

   • The instructions from the manufacturer of the cleaning agents and the washer/disinfector must be followed.
   • Chose a suitable cleaning agent and cleaning program (according to ISO 15883).
   • Recommendation: A program with disinfection lasting at least 5 min. at 93 °C or an alternative, comparable program.

5. Reassembly

   The handle can be reassembled before packaging for hydrogen peroxide low-temperature sterilization: Insert the laryngoscope insert and bottom insert into the handle shell and close it. (with the exception of HEINE rechargeable batteries and their bottom inserts)

6. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing after reprocessing.

7. Packaging of the handle for sterilization

   Pack the items individually in single or double standardized sterilization pouches suitable for the selected sterilization process.

8. Sterilization

   8.1 STERRAD sterilization of the handle

   Equipment

   • STERRAD NX, 100NX or 100S Sterilizer

   Implementation

   Perform the STERRAD NX Standard or Advanced cycle.

   8.2 VHP (Steris) sterilization of the handle

   Equipment

   • V-PRO 60 Sterilizer, V-PRO maX Sterilizer
   • VAPROX HC Sterilant

   Implementation

   Perform the V-PRO 60 or V-PRO maX Sterilizer's Lumen Cycle.

9. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

Chapter E: Manual cleaning (brushing), Low temperature Sterilization STERRAD / VHP (Steris)

1. Point of use

   Gross contamination must be removed soon after use, e. g. with a disposable wet wipe or enzymatic pre-cleaner.

2. Containment and transportation

   Reprocess as soon as possible following use.

3. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Clean and disinfect the laryngoscope handle insert and bottom insert as described in Chapter A.

4. Manual cleaning of the handle shell by brushing

   Equipment

   • Cleaning agent: enzymatic or neutral to mildly alkaline (e. g. CIDEZYME by ASP).
   • Warm (30 - 40 °C) demineralized water, soft plastic brushes.

   Implementation

   • Soak the handle shell for 1 min. submerged in the cleaning solution (30-40 °C).
   • Clean all surfaces of the handle shell by brushing (submerged in the cleaning solution).
   • Pay particular attention to recesses, ridges, difficult to access areas of the snap-in mechanism, below the hinge and the inner surfaces of the handle shell.
   • For removing the cleaning agent and drying afterwards, follow the instructions provided by the manufacturer of the cleaning agent.

5. Reassembly

   The handle can be reassembled before packaging for hydrogen peroxide low-temperature sterilization: Insert the laryngoscope insert and bottom insert into the handle shell and close it. (with the exception of HEINE rechargeable batteries and their bottom inserts)

6. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing after reprocessing.

7. Packaging of the handle for sterilization

   Pack the items individually in single or double standardized sterilization pouches suitable for the selected sterilization process.

8. Sterilization

   8.1 STERRAD sterilization of the handle

   Equipment

   • STERRAD NX, 100NX or 100S Sterilizer

   Implementation

   Perform the STERRAD NX Standard or Advanced cycle.

   8.2 VHP (Steris) sterilization of the handle

   Equipment

   • V-PRO 60 Sterilizer, V-PRO maX Sterilizer
   • VAPROX HC Sterilant

   Implementation

   Perform the V-PRO 60 or V-PRO maX Sterilizer's Lumen Cycle.

9. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

Chapter F: Automated cleaning and disinfection, steam sterilization of the handle shell

1. Point of use

   Gross contamination must be removed soon after use, e. g. with a disposable wet wipe or enzymatic pre-cleaner.

2. Containment and transportation

   Reprocess as soon as possible following use.

3. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Clean and disinfect the laryngoscope handle insert and bottom insert as described in Chapter A.

4. Cleaning and disinfection

   If it is required in your institution or your country, you can perform manual cleaning of the handle shell by brushing before automated cleaning and disinfection.

   4.1 Automated cleaning and disinfection

   Equipment

   • Washer/disinfector that conforms to the requirements of ISO 15883 or has a validated procedure corresponding to ISO 15883.
   • Cleaning agent: enzymatic or neutral to mildly alkaline (e. g. CIDEZYME by ASP).
   • Neutralizing agent if specified by the cleaning agent manufacturer.

   Implementation

   • The instructions from the manufacturer of the cleaning agents and the washer/disinfector must be followed.
   • Chose a suitable cleaning agent and cleaning program (according to ISO 15883).
   • Recommendation: A program with disinfection lasting at least 5 min. at 93 °C or an alternative, comparable program.

5. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing at the end of the reprocessing.

6. Packaging for sterilization

   Only the handle shell can be steam sterilized.

   Pack the items individually in single or double standardized sterilization pouches suitable for the selected sterilization process.

7. Steam sterilization

   Equipment

   • Steam sterilizer (Class B according to DIN EN 13060)

   Implementation

   Use one of the following programs (ISO 17665):

   • Fractionated vacuum procedure (at least 3 pre-vacuum cycles) and gravitation procedure:
   • Sterilization temperature: at least 132 °C (max. 134 °C)
   • Exposure time/holding time: at least 3 min.
   • Drying time: at least 20 min.

8. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

9. Reassembly

   Insert the laryngoscope insert and bottom insert into the handle shell and close it.

Chapter G: Manual cleaning (brushing) and steam sterilization of the handle shell

1. Point of use

   Gross contamination must be removed soon after use, e. g. with a disposable wet wipe or enzymatic pre-cleaner.

2. Containment and transportation

   Reprocess as soon as possible following use.

3. Preparation

   Disassemble the blade from the handle and reprocess separately.

   Disassemble the handle for reprocessing.

   Clean and disinfect the laryngoscope handle insert and bottom insert as described in Chapter A.

4. Manual cleaning by brushing

   Equipment

   • Cleaning agent: enzymatic or neutral to mildly alkaline (e. g. CIDEZYME by ASP).
   • Warm (30 - 40 °C) demineralized water, soft plastic brushes.

   Implementation

   • Soak the handle shell for 1 min. submerged in the cleaning solution (30-40 °C).
   • Clean all surfaces of the handle shell by brushing (submerged in the cleaning solution).
   • Pay particular attention to recesses, ridges, difficult to access areas of the snap-in mechanism, below the hinge and the inner surfaces of the handle shell.
   • For removing the cleaning agent and drying afterwards, follow the instructions provided by the manufacturer of the cleaning agent. Pay particular attention to remove residues from recesses and ridges.

5. Inspection and function testing

   Check the handle for any visible contaminants or abrasions. Reprocess again if necessary. Dispose if the contaminants cannot be removed.

   Perform functional testing at the end of the reprocessing.

6. Packaging for sterilization

   Only the handle shell can be steam sterilized.

   Pack the items individually in single or double standardized sterilization pouches suitable for the selected sterilization process.

7. Steam sterilization

   Equipment

   • Steam sterilizer (Class B according to DIN EN 13060)

   Implementation

   Use one of the following programs (ISO 17665):

   • Fractionated vacuum procedure (at least 3 pre-vacuum cycles) and gravitation procedure:
   • Sterilization temperature: at least 132 °C (max. 134 °C)
   • Exposure time/holding time: at least 3 min.
   • Drying time: at least 20 min.

8. Storage

   Store it in such a way that it is protected from recontamination, dust and moisture.

9. Reassembly

   Insert the laryngoscope insert and bottom insert into the handle shell and close it.