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INTERNAL PADDLES INSTRUCTIONS FOR USE

Appendix Reprocessing Instructions

Processing of resterilizable products according to din en ISO 17664:2004

Device:

 reusable internal paddles, comprising cables, connector, handles and 

spoons.

Note: 

 

z

Reusable internal paddles including three different types which are with coated 

spoons of 1-inch, 2-inch and 3-inch diameters respectively.

Warnings

 

z

Stainless steel spoons could be damaged by acidic detergents 

and solutions. Do not soak in NaCl solution to avoid corrosion.

 

z

Please observe the information and user instructions 

provided by the manufacturers of washer-disinfector, 

sterilizer and the detergent.

 

z

Open the package just before the use to avoid the sterilized 

internal paddles being contaminated. 

 

z

Check the wrap before use. Remove the internal paddles from 

use in case that package is damaged. 

 

z

Use before sterilization expiry. Sterilize the internal paddles 

again in case of expiry.

Limitation and 

restrictions on 

reprocessing

The internal paddle set could withstand 50 cycles of moist heat 

sterilization using the provided sterilization parameters.
Remove the internal paddle set from use in case of the following 

problems:

 

1.  Cable conductors, cable are damaged. 
2.  Insulation coating on the stainless steel spoons is detached 

from the stainless steel surface. 

3.  Insulation coating is frayed, damaged or have burrs. 
4.  The internal paddle set has cracks, notches, and worn parts.

Summary of Contents for MR6501

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

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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