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INTERNAL PADDLES INSTRUCTIONS FOR USE

Product Information

Intended Use

The internal defibrillation paddles (in short, the internal paddles) are intended to 

deliver an electrical pulse directly to the patient’s heart for the purpose of internal 

cardiac defibrillation during thoracotomy. Therapy energy is delivered by the op-

erator’s pressing the shock button on the defibrillator. The internal defibrillation 

paddles are intended to be used with Mindray Defibrillator/Monitor.

Models

Model

Electrode diameter

Cable length

MR6501

2.5 cm (1 inch)

5.3 m

MR6502

5.1 cm (2 inch)

MR6503

7.6 cm (3 inch)

Caution

 

z

Choose the appropriate model based on size of the paddles and the practical 

situation of the patient.

 

z

The MR6501 paddles does not comply with IEC 60601-2-4 for surface area 

recommendations for defibrillation paddles. 

 Warnings

 

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The internal paddles shall only be used by trained clinical professionals and with 

Mindray BeneHeart series defibrillator/monitors. The operator shall be liable for 

understanding this manual or consulting with us to confirm the compatibility of 

internal paddles and defibrillator. Otherwise, product performance may be com-

promised or personal injury may occur.

 

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During charging or shock delivery, hold only the insulating parts of the electrode 

handles to avoid being shocked.

 

z

Make sure your hands are dry to avoid being shocked.

 

z

Make sure the internal paddles are sterilized before each use. Otherwise, severe 

infection may result.

 

z

Protect the internal paddles from impact to each other, other instrument or hard 

surface when not in use. 

 

z

Dispose of internal paddles according to local regulations or your hospital’s protocol.  

Содержание MR6501

Страница 1: ...Shenzhen Mindray Bio Medical Electronics Co Ltd Internal Defibrillation Paddles Instructions for Use...

Страница 2: ......

Страница 3: ...ons for use z z this product is not damaged by human factors Human factors refer to unin tentional falling intentional damaging etc In the event that it becomes necessary to return a unit to Mindray p...

Страница 4: ...comply with IEC 60601 2 4 for surface area recommendations for defibrillation paddles Warnings z z The internal paddles shall only be used by trained clinical professionals and with Mindray BeneHeart...

Страница 5: ...or chipped coating z z Check paddle handles cables and connectors for damaged pins or material deterioration Function Check 1 Turn on the defibrillator and enter the Manual Defib mode 2 Select the app...

Страница 6: ...d left ventricle as shown in the figure below 4 Charge the defibrillator by pressing the Charge key on the front panel 5 Make sure no one is touching the patient or anything connected to the patient 6...

Страница 7: ...ge from higher energies Cleaning disinfection and Sterilization Clean and sterilize the internal paddles after each use Do not allow the insulating handles or paddle electrodes to dry after use and be...

Страница 8: ...internal paddles from the defibrillator 2 Use a volt ohm meter or a digital multimeter to verify the resistance between the test points in the following table Be sure that good electrical contact is m...

Страница 9: ...USA restricts this device to sale by or on the order of a physician 1639 Mark of conformity to European Medical Device Directive 93 42 EEC Operation and Storage Environment Operating temperature 0 to...

Страница 10: ...fector sterilizer and the detergent z z Open the package just before the use to avoid the sterilized internal paddles being contaminated z z Check the wrap before use Remove the internal paddles from...

Страница 11: ...environment Preparation before cleaning No particular requirements Disassembly not required Manual cleaning and disinfection method 1 Dampen the surface of the product with running water prior to cle...

Страница 12: ...nutes Packaging Seal the product into a standard pouch that is compatible with moist heat sterilization using the heat sealing machine Ensure that the pack is large enough to contain the paddles witho...

Страница 13: ...s materials and machines were used during the validation Cleaning agents Neodisher Dr Weigert Washer disinfector G7895 Miele Protein residue swab Protein residue swab 3M Packaging materials Fully Peel...

Страница 14: ...al Park Nanshan Shenzhen 518057 P R China Tel 86 755 81888998 Fax 86 755 26582680 E mail service mindray com cn 518057 24 4007005652 86 755 81888998 86 755 26582680 Shanghai International Holding Corp...

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