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9

INTERNAL PADDLES INSTRUCTIONS FOR USE

Instructions

Preparation at 

the point of use

Remove contamination from surface immediately after use with 

soft paper/cloth; or,
Rinse the product with running tap water (<40

) for at least one 

minute until all visible residues are removed.

Note:

 

z

Do not use a fixating detergent or hot water (>40

) as this 

can cause the fixation of residua which may influence the 

result of the reprocessing process.

Transportation

Reprocess the product as soon as possible after use. Safe storage 

and transportation to the reprocessing area to avoid any damage 

to the product and contamination to the 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 cleaning.

2.  Add appropriate volume of pH-neutral enzymatic deter-

gent at a concentration of 0.5% to the surfaces according to 

the instructions from the supplier of the detergent.

3.  Apply the cleaning agent to all the surfaces of the product 

for 5 minutes at 55

 (no less than 40

) with soft brush.

4.  Rinse the product using running water from external sur-

faces for a minimum of 1 minute until there is no visual con-

taminant.

5.  Rinse the product using running water for at least 2 min-

utes.

6.  Rinse the product using de-ionized water for 5 minutes at 

93

 (no less than 88

).

7.  Check the protein residue with 3M protein residue swab.

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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