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INTERNAL PADDLES INSTRUCTIONS FOR USE

Note

When internal paddles are used for defibrillation, the energy selection is auto-

matically limited to 50 joules because of possible cardiac damage 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 before cleaning. Items contami-

nated with blood and /or other protein materials cannot be effectively cleaned if

allowed to dry.

For more details, please refer to

Appendix Reprocessing Instructions

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...