HASSON TROCARS Instructions for Use

Ackermann

HASSON TROCARS APPENDIX All product codes covered by these instructions are listed below: hasson trocars INCL. BLUNT OBTURATOR 10-1067

10-1067-05

10-1067-10

SYMBOLS USED ON LABELLING (ACC. DIN EN ISO 15223-1) Legal manufacturer Manufacturing date Consult instructions for use Batch code Product number Quantity Caution, consult accompanying documents Do not use if package is opened or damaged Non-sterile Keep out of direct sunlight Protect against moisture ONLY

0483

Prescription use only mdc medical device certification GmbH, Kriegerstraße 6, 70191 Stuttgart, Germany

CONTACT DETAILS Ackermann Instrumente GmbH Eisenbahnstrasse 65-67 78604 Rietheim-Weilheim Germany Phone: Fax: E-Mail: Web:

GUIDELINES FOR CARE, MAINTENANCE & CLEANING SAFETY INSTRUCTIONS These Guidelines for Care, Maintenance and Cleaning are not a substitute for the Instructions for Use. Before using the instrument Read and follow the Guidelines for Care, Maintenance and Cleaning. Keep these instructions in a place where they can be easily seen for reference at a later date.

OVERVIEW OF REPROCESSING METHODS

SCOPE

VALIDATED REPROCESSING METHODS In the following synoptic table, the validated reprocessing methods are shown itemised according to the instrument groups. The individual instruments are assigned to the different reprocessing groups in the respective Instructions for Use. This synoptic table is not a substitute for the following sections of these Guidelines for Care, Maintenance and Cleaning.

These Guidelines for Care, Maintenance and Cleaning are valid for all products where explicit reference is made to the Guidelines for Care, Maintenance and Cleaning in the Instructions for Use.

Reprocessing step

EXPLANATION OF SYMBOLS

Reprocessing methods

Risk of infection • Reprocess the instrument before initial use. • Reprocess the instrument before each use. • Reprocess the instrument before returning it to the manufacturer. • Follow the instructions for use of the cleaning agents and disinfectants used as well as of the cleaning and sterilisation devices used. • Wear personal protective equipment during reprocessing. • Discard disposable components after initial use. • Note the special reprocessing requirements if there is a suspicion of prions and Creutzfeldt-Jakob disease.

Reprocessing group 2

WARNING Indicates a hazard that can lead to death or serious injury if not avoided.

CAUTION Indicates a hazard that can lead to injury if not avoided. ++ Validated reprocessing method 0 Process not validated by the manufacturer - Incompatibility

MATERIAL COMPATIBILITY The following synoptic table shows for which instrument groups and which reprocessing methods materials are compatible. The user must validate these methods! The individual instruments are assigned to the different reprocessing groups in the respective Instructions for Use. This synoptic table is not a substitute for the following sections of these Guidelines for Care, Maintenance and Cleaning. Reprocessing step

Reprocessing methods

Reproc. group 1

Reproc. group 2

Risk of injury • Do not use damaged instruments and do not repair. • Only use original accessories.

7.8-8.8

WARNING Risk of infection and pyrogenicity from residues if unsuitable cleaning agents are used. • Do not use fixing agents. • Do not rinse with hot water

IMPORTANT Avoid damaging product. • Do not use abrasive brushes or scourers. • Only use the cleaning agents which are listed in this section. • Use disinfectant with corrosion protection.

Note: For warnings of personal injury, the danger sign according to ANSI Z535.6 is used in these operating instructions.

PREPARING DECONTAMINATION

Note: Rinse the instrument under the surface of the water. This prevents contamination of the surrounding area.

IMPORTANT Indicates measures to prevent damage to property.

To prevent surgical residue from drying on, the following steps must be performed directly after surgery. • Rinse the instrument with cold water. • Remove coarse dirt with cold water. • Rinse out cavities with cold water.

• Brush the outside and inside under cold water with a round brush until no more residue is visible. • Rinse out cavities, drill holes and threads (if relevant) with a cleaning gun: >10 s at 3-5 bar. • Remove from the water bath and rinse off with cold water. • Immerse in combined cleaning and disinfectant solution until subsequent cleaning to prevent any residue from drying on.

CLEANING & DISINFECTION General Information

PRE-CLEANING

+49 (0)7461 966 17 - 0 +49 (0)7461 966 17 - 70 [email protected] www.ackermannsurgical.com

Pre-cleaning prevents surgical residue from drying on. It must therefore be carried out directly after surgery.

Note:More detailed information on reprocessing is available from the Robert Koch Institute (RKI) and the Instrument Reprocessing Working Group (AKI): RKI: Hygiene Requirements for Reprocessing Medical Devices (www.rki.de, as last amended) AKI: Proper Maintenance of Instruments (www.a-k-i.org, as last amended)

4 // 28

0.8%

pH value

• Tip: Remove caked-on tissue residues with a plastic brush. • Immerse the instrument in a cold water bath with 0.8% cleaning solution: >5 min. • Brush the instrument under cold water until all visible signs of soiling have been removed. • Dismantle the instrument (if possible). / See instrument’s Instructions for Use. • Open stop cocks (if relevant).

Note: If it is not possible to rinse with cold water, the instrument must be wrapped in a moist cloth to prevent any residues from drying on. • Always transport the instrument to the reprocessing site in a closed container to prevent product damage and contamination of the environment.

+ Method with verified material compatibility 0 Process not validated by the manufacturer - Incompatibility

Page:

Enzymatic

Dosage

DANGER Indicates a hazard that will result in death or serious injury if not avoided.

The manufacturer does not assume any liability for damage as a result of incorrect reprocessing and care. The methods described for manual and mechanical reprocessing have been validated by the manufacturer. These are recommendations from the manufacturer. If using different and/or modified reprocessing methods, the user must provide proof of the effectiveness of the method The basic risks identified for the reprocessing process are summarised below based on the nature of the hazard. Warnings which relate to specific actions can be found directly next to the relevant action together with a classification of the risk. / See section “Explanation of symbols”.

Reprocessing group 1

Cleaning

Pre-cleaning was validated with the cleaning agent Cidezyme from Johnson & Johnson:

Note: Unless stated otherwise in the instrument’s Instructions for Use, cleaning is performed with the instrument disassembled. Unless specified otherwise in the description of the reprocessing method, use water of the following quality: • Pre-rinsing: Tap water • Cleaning and rinsing: Demineralised water • Final rinsing: Demineralised water

IFU_00001-6_10_Hasson _Trocars-Revision _04/21

Ackermann

HASSON TROCARS WARNING Risk of infection due to insufficient reprocessing. • Remove protective caps (if relevant).

IMPORTANT Avoid damaging product. • Do not use abrasive brushes or scourers. • Only use the cleaning agents which are listed in the individual sections. • With plastic instruments avoid contact with hydrogen peroxide (H2O 2). • Choose between manual and mechanical cleaning.

WARNING Risk of infection due to insufficient reprocessing. • Special reprocessing requirements must be observed if there is a suspicion of prions and Creutzfeldt-Jakob disease. / To this end, note Annex 7 of the recommendation “Hygiene Requirements for Reprocessing Medical Devices” from RKI and BfArM.

a cleaning gun with cold water: >20 s at 3-5 bar. • Unless specified otherwise in the instrument’s Instructions for Use, clean the components in the ultrasonic bath with 0.8% cleaning agent with the following settings: Temperature

Frequency

Duration

40-45°C

35 kHz

10 - 15 min.

Chemical Disinfection Manual cleaning was validated with the cleaning agents Cidezyme/Enzol from Johnson & Johnson and Mucadont Zymaktiv from Merz Hygiene GmbH: Cleaning agent

Cleaning

Dosage

Cidezyme/Enzol

Enzymatic

0.8%

Mucadont Zymaktiv

Enzymatic

0.8%

Note: Rinse the instrument under the surface of the water. This prevents contamination of the surrounding area.

Preparation Dismantle the instrument (if possible). / See instrument’s Instructions for Use.

• Place the instrument in cold water: >10 min. • Brush the instrument under cold water until all visible signs of soiling have been removed. • Rinse out cavities, drill holes and threads with

Page:

6 // 28

Cleaning

CHECKING & CARE

• Unless specified otherwise in the instrument’s Instructions for Use, additionally clean the components prior to or in combination with mechanical cleaning in an ultrasonic bath with the following settings:

The right care of instruments will lengthen their service life and should therefore be carried out after every cleaning process.

Temperature

Frequency

Duration

40-45°C

35-45 kHz

10 - 15 min.

Note: Also clean the inner chambers of the instrument below water using a cleaning brush.

• Turn and move the components several times during cleaning in the ultrasonic bath.

Drying • Dry on the inside and outside: >10 min. at 50-100°C and/or blow through with sterile compressed air.

Disinfection was validated with the disinfectant Mucocit-T from Merz Hygiene GmbH: • Disinfect with disinfectant: >10 min. / See manufacturer’s Instructions for Use Disinfect

Dosage

pH value

Mucocit-T

4%

10.5 (diluted)

Proper cleaning depends on the right cleaning program. Compare the cleaning program with that of your cleaning system and save where necessary: Start the cleaning program. 1. Pre-rinsing with cold water: 1 min. 2. Emptying 3. Repeated pre-rinsing with cold water: 3 min. 4. Emptying 5. Cleaning with 0.5% alkaline cleaning agent: at 55°C for 5 min. 6. Emptying 7. Neutralising with deionised water: 3 min. 8. Emptying 9. Rinsing with deionised water: 2 min. 10. Emptying

Drying

Manual Cleaning (ALKALINE) & THERMAL Disinfection Mechanical cleaning was validated with the cleaning device G 7735 CD from Miele. Mechanical alkaline cleaning was validated with the cleaning agent Neodisher FA from Dr. Weigert: Cleaning

Dosage

Alkaline

0.5%

pH value 12.2-14 (diluted)

• Open stop cocks (if relevant).

Cleaning

/ Observe the national requirements as regards the A0 value (see ISO 15883)

• Turn and move the components several times during cleaning in the ultrasonic bath. • Rinse out cavities, drill holes and threads with a cleaning gun with cold water: >20 s at 3-5 bar. • Immerse the instrument in deionised water and rinse through the cavities several times with deionised water.

Disinfection Manual Cleaning (enzymatic) &

cleaning agent can reach all inner and outer surfaces. • Connect flush opening (if any) to MIS mobile unit.

Preparation • Dismantle the instrument (if possible). / See instrument’s Instructions for Use. • Open stop cocks (if relevant). • Place instruments in a sieve tray on the cleaning device MIS mobile unit so that the

* Deionised/demineralised water

WARNING Risk of injury from faulty or damaged components Do not use damaged instruments and do not repair. • Check to ensure they are clean and, if necessary, repeat cleaning. • Check for damage (e.g., sharp edges, rough surfaces). • Replace brittle and cracked seals (if relevant). • Lubricate moving parts (e.g., joints, rotating stop cocks) with medical oil. • Remove any excess oil. • Assemble instruments (if possible) and check to ensure they are in perfect working order. / See instrument’s Instructions for Use.

PACKAGING The instrument must be packed appropriately prior to sterilisation to ensure that the sterile barrier remains intact after removal from the steriliser. • Package the instrument to comply with ISO 11607 and EN 868.

• Dry inside and outside in the cleaning and disinfection device: 15-25 min. at 90-110°C. The cleaning and disinfection device cycle must include a drying phase. • Remove the product from the cleaning and disinfection device immediately at the end of the cycle. • If necessary, also blow through the product with sterile compressed air until it is completely dry.

STERILIZATION Unless stated otherwise in the instrument’s Instructions for Use, sterilisation is performed with the instrument assembled. / See instrument’s Instructions for Use.

Disinfection

Sterilisation was validated with the sterilisation device Selectomat S 3000 from MMM Group and Varioclav 400 E from Fisher Scientific.

Disinfection was validated with the device Getinge 88 series:

IMPORTANT

Disinfect

Avoid damaging product. • Observe the device’s maximum load. / See manufacturer’s Instructions for Use.

Demineralised water*

Temperature

Dwell time

90+3°C

≥ 5 min

WARNING

REPAIR

Risk of infection reprocessing.

due

to

insufficient

• Special reprocessing requirements must be observed if there is a suspicion of prions and Creutzfeldt-Jakob disease.

WARNING Risk of injury from improper repairs. • Only allow repairs to be performed by the manufacturer or by persons authorised by the manufacturer.

WARNING

Sterilisation was validated at 134°C and 4 minutes. The sterilisation time must therefore be at least 4 minutes. The following countries make different stipulations which must be observed: Country

Sterilization time

Germany

≥ 4 - 30 min.

France

≥ 18 - 30 min.

Switzerland

≥ 18 - 30 min.

• Open stop cocks (if relevant). • Place in the sterilisation device so that the components are not touching each other and the steam can circulate freely. • Set the sterilisation parameters (3-fold fractionated pre-vacuum):

134 -137°C

Pressure

Duration

3 bar

/ See details in

44 psi

this section.

• Send the instrument back to the manufacturer in a reprocessed state and in its original packaging. / See manufacturer’s address

DISPOSAL

Note: Dwell times of 4-30 min. do not have a negative influence on the instrument/material.

Temperature

Risk of infection from non-sterile instruments. • Reprocess the instrument before returning it to the manufacturer.

• Start the sterilisation process.

STORAGE OF STERILE DEVICES To avoid reducing durability and forfeiting any resistance to bacteria the following storage conditions must be observed: • Store the sterile device sealed in a clean, dust-free and dry sterile container. • Protect from direct light. • Store the sterile container in a clean and dry environment with controlled humidity at room temperature. • Do not store the sterile container in the vicinity of aggressive substances (e.g., alcohols, acids, bases, solvents and disinfectants).

Environmentally sound disposal enables valuable raw materials to be recycled. Dispose of the device in an environmentally friendly manner in accordance with the valid hospital guidelines.

INFORMATION ON VALIDATION The following materials and machines were used for validation: Cleaning agent: • Cidezyme/Enzol from ASP • Mucadont Zymaktiv from Merz Hygiene GmbH • Neodisher FA from Dr. Weigert • deconex 23 Neutrazym from Borer Disinfectant: • Mucocit-T from Merz Hygiene GmbH Cleaning and disinfection devices: • G 7735 CD from Miele Sterilisation devices: • Selectomat S 3000 from MMM Group • Varioclav 400 E from Fisher Scientific Sterilising agent: • Moist heat End of document

Note: Also observe your internal storage standards for sterile devices.

IFU_00001-6_10_Hasson _Trocars-Revision _04/21