Pneumo-Cryoprobe; flexible

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NOTES ON USE EN

Pneumo-Cryoprobe; flexible 20402-032, 20402-037, 20402-040

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Table of Contents 1 2 3 4 5

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IMPORTANT!... 23 Intended Use... 23 Normal Use... 23 Safety instructions... 23 Product overview... 25 How to use... 26 5.1 Check the product... 26 5.2 Connect up the product... 26 5.3 Selecting effect and timer settings... 27 5.4 Checking function and seal... 27 5.5 Using the product... 27 5.6 Disconnect the product from the unit... 30 5.7 Precleaning the product in the procedure room... 30 Cleaning, disinfection, sterilization... 30 6.1 Safety instructions... 30 6.2 Reprocessing limitation... 31 6.3 Recommended equipment / substances... 31 6.4 Recommended methods... 32 6.5 Required Aids... 32 6.6 Precleaning... 32 6.7 Manual cleaning and disinfection... 33 6.8 Place the flexible cryoprobe in the wash and sterilization holder... 34 6.9 Cleaning and disinfection by machine... 34 6.10 Check... 35 6.11 Packaging... 35 6.12 Sterilization... 36

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IMPORTANT! Please read all information carefully. These instructions for use do not replace the user manual of the cryosurgical unit used! Read the user manual of the cryosurgical unit and ask Erbe or your distributor in case of doubt!

1 Intended Use The instruments are intended for cryoadhesion and devitalization in bronchoscopy or interventional pulmonology.

2 Normal Use The instruments are connected to the ERBECRYO 2.

3 Safety instructions WARNING! This product may be used only by trained medical staff, who have been shown how to use it according to the instructions for use. The product is not suitable for continuous operation. During each use, activate the freeze function for no more than 15 minutes in total (not including activation breaks). The impact of the cold could interfere with or damage cardiac pacemakers. If the operating field is in the immediate vicinity of a cardiac pacemaker, a cardiologist must always be consulted prior to the operation! Check the product including the tube, connector and O-rings for damage before each use. If damaged, do not use this product! 23

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In particular, do not use a product with an application element that is kinked, crimped or has surface damage. Check the product function and seal before each use. Never use a product that is not leak-tight or a product with inadequate freezing capacity. There is a risk that a gas embolism could develop if an application element is used that is not leaktight. Never lay this product on the patient or in his/her direct vicinity. When the ERBECRYO 2 is activated, a freeze zone develops at the cryotip with temperatures significantly lower than 0 °C. Avoid unintentional contact with tissue. When unplugged, always keep the cryoconnector securely closed with the protective cap. This applies particularly to transport and storage. Protect this product from any form of mechanical damage! Do not throw! Do not use force! Erbe recommends always placing the product in the wash and sterilization holder (art. no. 30402-085), except during use or manual reconditioning. Only roll up the application element loosely; do not kink or crimp it. Only roll up the connection hose loosely; do not kink or crimp it. Only transport and store the product in the original packaging or in packaging that offers equivalent protection. Erbe recommends placing the product in the wash and sterilization holder (art. no. 30402-085) for transport and storage. Erbe Elektromedizin expressly warns against modifying the product. Any modification exempts Erbe Elektromedizin from any and all liability.

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4 Product overview 3 4

5

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8 1

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1 2 3 4 5 6 7 8

Handle Connection hose Cryoconnector Release button Protective cap (removed) Application element Cryotip Wash and sterilization holder (art. no. 30402-085) for flexible cryoprobes

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5 How to use Clean, disinfect and sterilize the product before using it for the first time and before every subsequent use. Allow the product to cool down completely before use.

5.1

Check the product

1. Remove the product carefully from the wash and sterilization holder. 2. Check the product including the tube, connector and O-rings for damage. If damaged, do not use this product! In particular, do not use a product with an application element that is kinked, crimped or has surface damage.

5.2

Connect up the product

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1

2 1. Press the release button (1) and remove the protective cap (2) from the cryoconnector. 2. Plug the cryoconnector into the instrument receptacle (3) of the ERBECRYO 2. Make sure that the cryoconnector audibly engages with a click. The ERBECRYO 2 recognizes the connected product and automatically selects the unit settings stored for the product. 26

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You can change the effect and timer settings as required.

5.3

Selecting effect and timer settings

Note: For tissue devitalization, always select the highest effect that can be set for the product. 1. You can change the effect and timer settings as required (see the ERBECRYO 2 User Manual).

5.4

Checking function and seal

Perform the check in a well-lit location. 1. Immerse the cryotip to a depth of at least 5 cm in sterile warm water at a temperature of approx. 20 °C (alternatively: isotonic NaCl solution). 2. If small bubbles develop during immersion: Diffuse the bubbles by briskly moving the cryotip back and forth in the water. 3. Activate the freeze function of the ERBECRYO 2 for approx. 5 seconds. A clearly visible, homogenous ball of ice must form at the cryotip when freezing capacity is sufficient. Gas bubbles must not escape under any circumstances. Never use a product that is not leak-tight or a product with inadequate freezing capacity. There is a risk that a gas embolism could develop if an application element is used that is not leaktight.

5.5

Using the product

Note: To prevent the cryotip from freezing to the inside of the endoscope, the metal cryotip should be fully extended outside of the working channel of the endoscope throughout use. The first black ring must be visible. 27

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WARNING! Bending the application element of the flexible cryoprobe back and forth regularly during endoscopy! Bending the application element (particularly the cryotip) back and forth regularly when angling the endoscope or an Albarran catheter deflector can damage the application element. Gas can escape from the damaged application element and result in a gas embolism. • Avoid angling the endoscope too steeply. • Avoid excessive use of the Albarran catheter deflector. WARNING! Loud noise due to escaping gas! If the cryoconnector is unplugged before the bleed-off phase has been completed, gas escapes from the system making a loud noise. The user may be startled and injure the patient as a result. • Before use, verify that the cryoconnector is properly locked. • Only release and unplug the cryoconnector after use, when the bleed-off phase has been completed (on ERBECRYO 2, the bleed-off symbol is no longer shown). Devitalizing tissue, recanalization (as a result of tissue necrosis) 1. Insert the instrument through the working channel of the endoscope. 2. Place the cryotip on the target tissue while applying light pressure, and activate the ERBECRYO 2 freeze function. 3. When the tissue has frozen, deactivate the ERBECRYO 2 freeze function and wait until the cryotip has thawed completely. Note: When the cryotip has thawed completely, it can be removed from the tissue with minimal effort. Do not remove the cryotip by rotating or pulling. 4. Carefully remove the cryotip from the tissue. 5. Remove the instrument from the endoscope. Make sure that the angle of the endoscope is not too steep and the probe is not clamped.

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Extracting tissue samples, removing foreign bodies, recanalization (through tissue extraction) Avoid unintentional contact between healthy tissue and the freeze zone of the activated cryoprobe, e.g. by using a tube. 1. Insert the instrument through the working channel of the endoscope. 2. Place the cryotip on the target tissue or foreign body while applying light pressure, and activate the ERBECRYO 2 freeze function. 3. While activating the freeze function of the ERBECRYO 2 permanently, perform the following steps: – Remove the tissue or the foreign body by withdrawing the instrument together with the endoscope from the operating field. Do not rotate the cryo instrument. – Withdraw the endoscope together with the instrument. 4. To detach the sample, deactivate the freeze function of the ERBECRYO 2 and allow the instrument to thaw completely (e.g. immersed in a specimen container filled with liquid). 5. Remove the instrument from the endoscope. Make sure that the angle of the endoscope is not too steep and the probe is not clamped.

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5.6

Disconnect the product from the unit

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1. Press the release button (1) and remove the cryoconnector from the ERBECRYO 2. 2. Place the protective cap (2) onto the cryoconnector. Make sure that the protective cap audibly engages with a click.

5.7

Precleaning the product in the procedure room

1. Use a soft cloth (such as a compress) to remove any obvious contamination immediately after use and/or place the product in deionized water. Erbe recommends placing the flexible cryoprobe in the wash and sterilization holder when transporting for processing (see page 34).

6 Cleaning, disinfection, sterilization 6.1

Safety instructions

Suitable for cleaning in an ultrasonic bath (max. 10 minutes per processing cycle). On no account use sharp or abrasive objects for cleaning purposes. The cryoconnector must be closed securely with the protective cap throughout the entire preparation process. 30

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Only roll up the application element loosely; do not kink or crimp it. Only roll up the connection hose loosely; do not kink or crimp it. Disinfectants must be rinsed off thoroughly after use. Maximum air pressure during drying: 2 bar. Maximum water pressure during rinsing: 4 bar. During machine cleaning and disinfection, do not exceed 95 °C. It is essential to follow the cleaning agent and disinfectant manufacturers’ instructions. During sterilization, do not exceed 138 °C. Do not sterilize in hot air.

6.2

Reprocessing limitation

The product must not be cleaned/disinfected, sterilized and reused more than 100 times. The product must be tested at least once a year. Contact Erbe Elektromedizin or your local sales partner for the test.

6.3

Recommended equipment / substances

The service life of the product, cleaning action and sterility are validated for the following cleaning and preparation procedures if the recommended or equivalent substances are used in accordance with the manufacturer's instructions. • Manual cleaning/disinfection with the detergent Cidezyme ® and disinfectant Cidex ® OPA (Johnson & Johnson Medical Limited, Gargrave, Skipton). • Machine cleaning and disinfection in a G 7836 CD disinfector (Miele & Cie. KG, Gütersloh, Germany) with the cleaning agent neodisher ® mediclean forte (Dr. Weigert GmbH & Co. KG, Hamburg, Germany) with the recommended washing program. 31

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6.4

Recommended methods

Erbe recommends the preparation procedures described below. Equivalent different procedures are possible if not explicitly excluded. It is incumbent on the user to ensure the suitability of the actual procedures used by means of suitable measures (e.g. validation, routine monitoring, check of material compatibility).

6.5

Required Aids

Reprocessing step

Items Needed

Precleaning

Soft plastic brush/soft cloth

Manual cleaning/ disinfection

Soft plastic brush/soft disposable cloth (low particle) Water dispensing gun (max. 4 bar) Compressed air gun (2 bar maximum)

Machine cleaning/ Recommendation: Wash and sterilization disinfection holder (art. no. 30402-085) Sterilization

6.6

Recommendation: Wash and sterilization holder (art. no. 30402-085)

Precleaning

The wash and sterilization holder must be processed in the same way as the product. Use water for precleaning, a non-fixing disinfectant if necessary. 1. Make sure that the cryoconnector is closed securely with the protective cap. 2. Remove the product if necessary from the wash and sterilization holder. 32

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3. Remove surface contaminants with a soft brush/cloth while holding the product in a water bath and/or rinsing the product under running water.

6.7

Manual cleaning and disinfection

The wash and sterilization holder must be processed in the same way as the product. Use a liquid detergent suitable for the preparation of a dipping bath. Use a disinfectant compatible with the detergent suitable for the preparation of a dipping bath. The detergent and disinfectant must be suitable for medical devices made of plastic and metal and have a pH value between 5.5 and 11. It is essential to follow the cleaning agent and disinfectant manufacturers’ instructions. 1. Prepare a cleaning bath and a separate disinfecting bath according to the manufacturer's instructions. 2. Also prepare a water bath. 3. Immerse the product completely in the cleaning bath, without the product touching other parts in the bath. Observe the recommended immersion time. 4. Thoroughly clean the surfaces with a soft brush/soft disposable cloth. 5. Immerse the product completely in the water bath and rinse the product while immersed with a water dispensing gun (min. 1 minute). In doing so, rinse the cryoconnector particularly thoroughly. 6. Rinse the surfaces with sterile, deionized water (at least 1 minute). 7. Repeat the preceding cleaning steps if the product still shows visible contamination. 33

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8. Immerse the product completely in the disinfectant bath, without the product touching other parts in the bath. Observe the recommended immersion time. 9. Rinse the surfaces with sterile, deionized water (at least 1 minute). 10. Dry the product with filtered compressed air.

6.8

Place the flexible cryoprobe in the wash and sterilization holder

Erbe recommends performing machine preparation and sterilization of the product while it is in the wash and sterilization holder.

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1. First place the handle (1) followed by the application element (2) in the wash and sterilization holder. 2. Roll up the connection hose (3) loosely.

6.9

Cleaning and disinfection by machine

The washer/disinfector must have fundamentally certified effectiveness (e.g. CE marking according to DIN EN ISO 15883). The detergent and disinfectant must be suitable for medical devices made of plastic and metal and have a pH value between 5.5 and 11. 34

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It is essential to follow the cleaning agent and disinfectant manufacturers’ instructions. 1. Place the product in a suitable rinsing basket carefully. In doing so make sure the product is not touching other instruments or parts of instruments. 2. Start a tested program with the following properties: – Thermal disinfection: 5 to 10 minutes at 90 to 93 °C (with a tolerance in accordance with DIN EN ISO 17665), A0 ≥ 3000. – Final rinse with distilled or deionized water. – Sufficient product drying. 3. If contaminants are still visible on the product after the end of the routine, repeat precleaning and machine cleaning and disinfection.

6.10 Check 1. Check the product for visible damage and wear: – Damage to the product, e.g. cracks, rough surface, splintering. – Damage to the product insulation and/or cable/connector insulation, e.g. cracks and breaks. – Damage to the coating of the cryotip. – Kinking and crimping of the application element. If damaged, do not use this product!

6.11 Packaging Make sure that the sterilization packaging is not damaged by the wash and sterilization holder. Select a sufficiently large sterilization packaging, for example.

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1. Pack the product in disposable sterilization packaging (single or double packaging) made from paper/polyethylene and/ or in a sterilization container.

6.12 Sterilization Only sterilize products that have been cleaned and disinfected. Erbe Elektromedizin recommends steam sterilization with the method described below. If other sterilization methods are used, Erbe Elektromedizin shall bear no responsibility. Steam sterilization • Fractionated vacuum method with adequate product drying • Holding time 3 to 18 minutes at 132 to 135 °C (with a tolerance in accordance with DIN EN ISO 17665) • Sterilizers in accordance with applicable national standards and regulations (e.g. DIN EN 13060 or DIN EN 285) • Sterilization process validated according to DIN EN ISO 17665 Please follow the recommendations issued by the sterilizer manufacturer concerning loading, handling, and drying times.

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INDICACIÓN DE USO ES

Pneumo-criosonda; flexible 20402-032, 20402-037, 20402-040

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INDICAZIONI PER L’IMPIEGO IT

Criosonda per pneumologia, flessibile 20402-032, 20402-037, 20402-040

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INDICAÇÃO DE UTILIZAÇÃO PT

Pneumo-criosonda; flexível 20402-032, 20402-037, 20402-040