VAPR HANDPIECE Instructions Rev F

ENGLISH Mitek VAPR Handpiece Rx Only (USA only) Please read all information carefully, in particular the User Manual which is provided with the Mitek VAPR Generator prior to using the device. The various components of the Mitek VAPR System are designed to be used together as a single unit. Failure to properly follow instructions may lead to electrical or thermal injury and result in improper functioning of device. IMPORTANT: This package insert is designed to provide instructions for use of the Mitek VAPR System. It is not a reference to electrosurgical technique. IMPORTANT: Use only Mitek VAPR Electrodes and accessories with the Mitek VAPR System. Indications Intended for connection of the Mitek VAPR Electrode to the Mitek VAPR Generator. Instructions for Use Before surgery 1. Switch on the Mitek VAPR Generator. Follow the instructions in the User Manual so that the Generator displays the symbol “CONNECT CABLE”. 2. Connect a sterilized MITEK VAPR Handpiece to the Generator. Follow the instructions in the User Manual so that the Generator displays the symbol “INSERT ELECTRODE.” 3. Connect a new Electrode to the Handpiece. Check that the Handpiece and Electrode are properly aligned before pushing together (See illustration). 4. For safety and convenience, Electrodes automatically preset the Generator to default output settings and restrict output levels to preserve Electrode integrity. The default settings for each Electrode are specified in the package insert for the Electrode. CAUTION: Verify that the VAPR Generator display matches the VAPR Electrode default setting specified on the package insert for the Electrodes. If the Generator display does not match the Electrode 

default settings refer to the User Manual for further instructions. 5. With the arthroscope having been inserted into the joint cavity, carefully insert the non-activated Electrode into the joint cavity under direct vision. CAUTION: Avoid the use of excessive force when inserting VAPR Electrodes. If the free passage of the Electrode is obstructed, remove, inspect, and try again rather than trying to force the Electrode tip past the obstruction. Using force to overcome an obstruction may result in damage to the Electrode tip and risk damage to the devices and injury to the patient. Changing VAPR Electrodes During Surgery 1. Carefully remove the Electrode from the joint cavity. Do not withdraw the Electrode while power is being applied. 2. Unlock the connector assembly and disengage the Electrode connector and VAPR Handpiece. Check that the VAPR Generator displays the symbol “INSERT ELECTRODE.” Avoid fluid contact with the proximal end of the Electrode/Handpiece interface. 3. Fit a new sterile Electrode as previously described. If the new Electrode has different default settings to the previous Electrode, check that the Generator display matches the Electrode default settings specified on the package insert for the Electrodes. If the new Electrode has identical settings to the previous Electrode, the Generator will retain the settings previously displayed prior to changing the Electrode. If the Generator display does not conform to the above descriptions refer to User Manual for further instructions. After surgery 1. Disassemble the VAPR Electrode and VAPR Handpiece. 2. Disconnect the Handpiece from the VAPR Generator. The Generator will now display the symbol “CONNECT CABLE.” Disconnect by pulling the plug body. Do not pull the cable. Pulling the cable may cause damage to the device. 3. Turn off the Generator. 4. Dispose of the single-use Electrodes. 

Prepare reusable accessories for cleaning and sterilization. Recommended Cleaning Procedure: 1. Remove all gross matter (blood, mucous, tissue) by wiping the VAPR Handpiece with a cloth or gauze pad and a mild cleaning solution or blood dissolving detergent. IMPORTANT: Do not immerse in reprocessing solutions. Do not use abrasive cleaning agents. Product damage may otherwise result. 2. Rinse thoroughly in running water. 3. Allow the Handpiece to drain thoroughly. 4. Remove residual cleansing agents with a water damp cloth. 5. Dry the device thoroughly before sterilizing. Recommended Sterilization Procedure: Steam sterilize the accessory device per recommendation below: Wrapped prevacuum cycle: 134 to 136 degrees C for 3 to 4 minutes. Drying times may vary with the type of wrapping material. Please refer to the sterilizer manufacturer for recommended drying times. After any sterilization and cleaning process, check the accessory devices for any damage (e.g. crush damage, cracking, or distortion). Discard if damage is observed. Warnings and Precautions The VAPR Handpiece and connector cable is intended for 20 reuse cycles only. Exceeding the recommended number of uses may result in electrical or mechanical failure during use or difficulty when assembling or disassembling the VAPR Electrode with the Handpiece. Ensure that accessory has been cleaned and sterilized before use. Place active accessories in a clean, dry, nonconductive and highly visible area away from the patient when not in use. Inadvertent contact may result in burns. Contact with drapes or other flammable materials may cause fire. Do not wrap accessory cable around metal objects. Wrapping cable around metal objects may induce currents that could lead to shocks, fire, or injury to the patient or surgical personnel. 

Patents Pending. All Rights Reserved.

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NL

NO

JOHNSON & JOHNSON Medical BV Computerweg 14 3800 AD Amersfoort JOHNSON & JOHNSON AB Pstboks 34 Nesbruveien 75 N-1375 Billingstad Kingdom of Norway

PL

JOHNSON & JOHNSON Poland Sp. z o.o. UL Szyszkowa 20 02-285 Warszawa, Poland

P

JOHNSON & JOHNSON Produtos Profissionals Estrada Consiglieri Pedroso, 69-A Queluz-de-Baixo 2745 Barcarena

RU

JOHNSON & JOHNSON LLC 43, Bolshaya Tulskaya Street Moscow, 115191 Russia

SK

S

TR

CN

TW

KR

JOHNSON & JOHNSON Slovakia, s.r.o. Jakubovo námestie 13 811 09 Bratislava Slovenská republika JOHNSON & JOHNSON AB Staffans Vag 2 S-191 84 Sollentuna Ethicon Limited Turkiye Irtibat Office (J&J Medical) Cumhuriyet Cd. Gursel Plaza No. 99 Kat: 5 81610 Kavacik JOHNSON & JOHNSON Medical China Ltd. 2F, Tower B, Pacific Century Place 2A, North Worker’s Stadium Road, Chaoyang District, Beijing 100027 JOHNSON & JOHNSON (HK) Ltd. Taiwan Branch 6F, 319, Sec. 2, Tun Hwa South Road Taipei 106 JOHNSON & JOHNSON Medical Korea Ltd. 14F kukje Building 191 Hangangro-2Ga Yangsan-Gu Seoul, Korea

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Australia: JOHNSON & JOHNSON Medical Pty. Ltd. 1-5 Khartoum Road North Ryde, NSW 2113 Canada:

JOHNSON & JOHNSON Medical Products 200 Whitehall Drive Markham, Ontario L3R 0T5

S. Africa:

JOHNSON & JOHNSON (Pty) Ltd. 2 Medical Street, (PO Box 273) Halfway House Midrand Gauteng S. Africa 1685

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