CE0124 Flexible Cryo Probes
Contents
1. 30416 170 Sheet 1 2 Manufacturer ERBE Elektromedizin GmbH Waldhornlestr 17 72072 Tubingen Germany Tel 49 7071 7550 Fax 49 7071 755 179 EMail info erbe med com www erbe med com Distributed by USA Territory ERBE USA Inc 2225 Northwest Parkway Marietta GA 30067 Customer Support 800 778 ERBE 3723 Tel 770 955 4400 Fax 777 955 2577 EMail sales erbe usa com www erbe usa com 04 13 Printed in Germany ERBE Elektromedizin GmbH 20416 031 20416 036 Flexible Cryo Probes IMPORTANT Please read all information carefully These notes on use do not replace the user manual of the cryosur gical unit used Read the user manual of the cryosurgical unit and ask ERBE or your distributor in case of doubt This Cryo Probe may only be used by trained medical staff that has been instructed on its use based upon these notes on use Caution Federal law USA restricts this device to sale by or on the order of a physician 1 Normal Use The ERBE Flexible Cryo Probe used with the ERBE ERBOKRYO CA Cryosurgical Unit is intended for devitalization destruction of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies mucous plugs necrotic tissue and tis sue biopsy by cryoadhesion Also see Clinical Indications in the ERBOKRYO CA User Manual The Cryo Probe is attached via a Connecting Adapter P N 20416 035 to the ERBOKRYO CA 2 Safety Ins2. detergent Dr Weigert GmbH amp Co KG Hamburg Germany in accordance with the recommended washing pro gram e Autoclave 30416 170 Sheet 2 2 Manufacturer ERBE Elektromedizin GmbH Waldhornlestr 17 72072 Tubingen Germany Tel 49 7071 755 0 Fax 49 7071 755 179 EMail info erbe med com www erbe med com Distributed by USA Territory ERBE USA Inc 2225 Northwest Parkway Marietta GA 30067 Customer Support 800 778 ERBE 3723 Tel 770 955 4400 Fax 777 955 2577 EMail sales erbe usa com www erbe usa com 04 13 Printed in Germany ERBE Elektromedizin GmbH 20416 031 20416 036 5 4 Recommended Methods ERBE recommends the preparation procedures described below Equivalent different procedures are possible if not explicitly exclud ed It is incumbent on the user to ensure the suitability of the actual procedures used by means of suitable measures e g validation rou tine monitoring check of material compatibility 5 5 Required Aids Reprocessing Items Needed step Precleaning Soft plastic brush soft disposable cloth Soft plastic brush soft disposable cloth low particle Manual cleaning disinfection Compressed air gun 29 psi 2 bar maxi mum Sterilization Recommendation Cleaning and steril ization container with filter e g art no P651830M 5 6 Precleaning Use water for precleaning a non fixing disinfectant if necessary 1 Make sure that the probe coup
3. filtered compressed air 5 8 Cleaning and Disinfection by Machine The washer disinfector must have fundamentally certified effective ness 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 Prohibited ingredients organic solvents oxidizing agents halogens aromatic halogenated hydrocarbons It is essential to follow the cleaning agent and disinfectant manufac turers 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 194 to 199 F 90 to 93 C with a tolerance in accordance with DIN EN ISO 17665 Ay 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 disin fection 5 9 Checking 1 Check the product for visible damage and wear Damage to the product e g cracks rough surface splinter ing 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 us
4. all 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 leak tight 4 4 Using the Product Note To prevent the cryotip from freezing to the inside of the en doscope the metal cryotip should be fully extended outside of the working channel of the endoscope throughout use The first black ring must be visible Devitalizing tissue recanalization as a result of tissue necro Sis 1 Insert the instrument through the working channel of the endo scope 2 Place the cryotip on the target tissue while applying light pres sure and activate the freeze function of the ERBOKRYO CA 3 When the tissue has frozen deactivate the freeze function of the ERBOKRYO CA and wait until the cryotip has thawed complete ly 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 severe and the probe is not crimped Extracting tissue samples removing foreign bodies recanali zation through tissue extraction Avoid unintentional contact between health
5. e entire prepara tion process with the protective cap Moisture penetrating into the tubing system causes malfunctioning 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 29 psi 2 bar Maximum water pressure during rinsing 29 psi 2 bar During machine cleaning and disinfection do not exceed 203 F 95 C It is essential to follow the cleaning agent and disinfectant manufac turers instructions During sterilization do not exceed 280 F 138 C Do not sterilize in hot air oven 5 2 Reconditioning Limitation The Cryo Probe 30416 031 must be tested in each case after 100 uses sterilizations but at least once per year The Cryo Probe 30416 036 must be tested in each case after 30 uses sterilizations but at least once per year Please contact ERBE USA for the test 5 3 Recommended Processing Agents Equipment The listed cleaning disinfection agents and sterilization equipment have been validated with the following processing procedures e Manual cleaning disinfection with the detergent Cidezyme LF Enzol and disinfectant Cidex OPA Johnson amp Johnson Medical Limited Gargrave Skipton e Cleaning disinfection by machine in a disinfector G 7836 CD Miele amp Cie KG GUtersloh Germany using neodisher medi clean forte
6. e this product 5 10 Packaging The product must be protected against damage during sterilization 1 Pack the product in disposable sterilization packaging single or double packaging made from paper polyethylene and or in a sterilization container 5 11 Sterilization Only sterilize products that have been cleaned and disinfected ERBE Elektromedizin recommends steam sterilization with the meth od described below If other sterilization methods are used ERBE Elektromedizin shall bear no responsibility Steam sterilization e Pre vacuum method with adequate product drying e Holding time 3 to 18 minutes at 270 to 275 F 132 to 135 C with a tolerance in accordance with DIN EN ISO 176655 e Sterilizers in accordance with applicable national standards and regulations e g DIN EN 13060 or DIN EN 285 e Sterilization process validated according to DIN EN ISO 17665 Please follow the recommendations issued by the sterilizer manufac turer concerning loading handling etc
7. ling is securely closed using the protective cap 2 Remove surface contaminants with a soft brush cloth while holding the product in a water bath and or rinsing the product under running water 5 7 Manual Cleaning and Disinfection Use a liquid detergent suitable for soaking Use a disinfectant compatible with the detergent suitable for soaking 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 Prohibited ingredients organic solvents oxidizing agents halogens aromatic halogenated hydrocarbons It is essential to follow the cleaning agent and disinfectant manufac turers instructions 1 Prepare a cleaning bath and a separate disinfecting bath accord ing to the manufacturer s instructions 2 Immerse the product completely in the cleaning bath without the product touching other parts in the bath Observe the rec ommended immersion time 3 Thoroughly clean the surfaces with a soft brush soft disposable cloth 4 Rinse the surfaces with sterile deionized water at least 1 minute 5 Repeat the preceding cleaning steps if the product or used rinse water still contains visible contamination 6 Immerse the product completely in the disinfectant bath with out the product touching other parts in the bath Observe the recommended immersion time 7 Rinse the surfaces with sterile deionized water at least 1 minute 8 Dry the product with
8. packaging that offers equivalent protection ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all lia bility 3 Product Overview 3 4 2 1 Probe coupling with protective cap screwed on Connection hose Handle Application element Cryotip UAWN 4 How to Use Clean disinfect and sterilize this product before using it for the first time and before every subsequent use Prior to use let the Cryo Probe cool to room temperature 4 1 Checking the Product 1 Check the product including connection hose probe coupling 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 4 2 Connecting the Product 1 Unscrew the protective cap from the probe coupling 2 Screw the Cryo Probe to the connecting adapter art no 20416 035 fitted on the ERBOKRYO CA 4 3 Checking Function and Seal Perform the check in a well lit location 1 Immerse the cryotip to a depth of at least 2 0 5 cm in sterile warm water alternatively isotonic NaCl solution at a tempera ture of approx 68 F 20 C 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 ERBOKRYO CA for approx 5 seconds A clearly visible homogenous b
9. tructions WARNING Pacemakers can be impaired or damaged by exposure to cold If the operating site is in the direct vicinity of a pacemaker it is absolutely essential to consult a cardiologist prior to performing an operation with a Cryo Probe Check gas pressure on the unit The Cryo Probe can be operated in a pressure range from 580 to 870 PSI 40 to 60 bar Do not expose the Cryo Probe to pressure above 870 PSI 60 bar red zone on the pressure gauge Check the product including connection hose probe coupling and O rings for damage every time before it is used 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 Check the product function and seal before each use Never use a product that is not leak tight or a product with inade quate freezing capacity There is a risk that a gas embolism could de velop if an application element is used that is not leak tight Never lay this product on the patient or in his her direct vicinity The probe coupling must be closed with the protective cap in trans port storage and sterilization Protect this product from any form of mechanical damage Do not throw Do not use force 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
10. y tissue and the freeze zone of the activated Cryo Probe e g by using a tube 1 Insert the instrument through the working channel of the endo scope 2 Place the cryotip on the target tissue or foreign body while ap plying light pressure and activate the freeze function of the ERBOKRYO CA 3 For removal 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 transfer the sample deactivate the freeze function of the ERBOKRYO CA and allow the instrument to thaw completely e g immersed in a collection tube filled with liquid 5 Remove the instrument from the endoscope Make sure that the angle of the endoscope is not too severe and the probe is not crimped 4 5 Disconnecting the Product from the Unit 1 Unscrew the Cryo Probe from the connecting adapter Art No 20416 035 2 Screw the protective cap onto the probe coupling 4 6 Precleaning the Product in the Procedure Room 1 Use a soft disposable cloth to remove any obvious contamina tion immediately after use and or place the product in deionized water 5 Cleaning Disinfection Sterilization 5 1 Safety Instructions May be cleaned in an ultrasonic bath On no account use sharp or abrasive objects for cleaning purposes The probe coupling must remain sealed during th
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