Mindray MR6501 User manual

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Internal Debrillation Paddles
Instructions for Use

1
INTERNAL PADDLES INSTRUCTIONS FOR USE
Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
called Mindray) owns the intellectual property rights to this product and this
manual. Disclosure of the information in this manual in any manner whatsoever
without the written permission of Mindray is strictly forbidden.
This manual provides the instructions necessary to operate the product in accor-
dance with its function and intended use. Observance of this manual is a prereq-
uisite for proper performance and correct operation, and ensures patient and
operator safety.
Mindray is responsible for the eects on safety, reliability and performance of this
product, only if:
zthe product is used in accordance with the instructions for use.
zthis 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, please contact
the Mindray Service Department and obtain a Mindray Customer Service Autho-
rization Number. The Mindray Customer Service Authorization Number must
appear on the outside of the shipping container. Return shipments will not be
accepted if the Mindray Customer Service Authorization Number is not clearly
visible. Please provide the model number, serial number, and a brief description
of the reason for return. The customer is responsible for freight charges when this
product is shipped to Mindray for service (including any relevant customs fees or
other freight related charges).
, ,
and are the registered trademarks or trademarks owned by Mindray
in China.
©2009-2020 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

2
INTERNAL PADDLES INSTRUCTIONS FOR USE
Product Information
Intended Use
The internal debrillation 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 debrillation during thoracotomy. Therapy energy is delivered by the op-
erator’s pressing the shock button on the debrillator. The internal debrillation
paddles are intended to be used with Mindray Debrillator/Monitor.
Models
Model Electrode diameter Cable length
MR6501 2.5 cm (1 inch)
5.3 mMR6502 5.1 cm (2 inch)
MR6503 7.6 cm (3 inch)
Caution
zChoose the appropriate model based on size of the paddles and the practical
situation of the patient.
zThe MR6501 paddles does not comply with IEC 60601-2-4 for surface area
recommendations for debrillation paddles.
Warnings
zThe internal paddles shall only be used by trained clinical professionals and with
Mindray BeneHeart series debrillator/monitors. The operator shall be liable for
understanding this manual or consulting with us to conrm the compatibility of
internal paddles and debrillator. Otherwise, product performance may be com-
promised or personal injury may occur.
zDuring charging or shock delivery, hold only the insulating parts of the electrode
handles to avoid being shocked.
zMake sure your hands are dry to avoid being shocked.
zMake sure the internal paddles are sterilized before each use. Otherwise, severe
infection may result.
zProtect the internal paddles from impact to each other, other instrument or hard
surface when not in use.
zDispose of internal paddles according to local regulations or your hospital’s protocol.

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INTERNAL PADDLES INSTRUCTIONS FOR USE
Warnings
zIf any of the following conditions is found, remove the internal paddles from
use immediately.
The sterile package of the paddles is damaged.
Paddle electrodes are scratched, pitted, or chipped conductive surfaces are
bubbled, scratched, or chipped coating.
Paddle handles and cables get damaged,connectors have damaged pins or material
deterioration.
Preparation
To ensure successful defibrillation, follow the instructions below before each use:
Visual Check
zCheck if the sterile package of the paddles is intact.
zCheck paddle electrodes for scratched, pitted, or chipped conductive surfaces
and bubbled, scratched, or chipped coating.
zCheck 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 appropriate paddle size.
3. Connect the paddles to the defibrillator by aligning the white pointer on the
paddles cable with the arrow on the therapy port. Push until you hear it click
into place.
4. Select energy by pressing the [Energy Select] key on the equipment’s front
panel. Make sure the maximum energy available is 50 Joules.
5. Press the [Energy Select] key repeatedly and select an energy of 2 Joules.
6. Charge the defibrillator by pressing the [Charge] key on the front panel.
7. Press the conductive surface of the paddle electrodes firmly together and press
the Shock key on the front panel. Make sure that the message “Impedance Too
Low“ is displayed on the debrillator.

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INTERNAL PADDLES INSTRUCTIONS FOR USE
Caution
zNever short the paddle electrodes in any conditions other than function
check.
Using Internal Paddles
1. Make sure the preparation is finished as directed above.
2. Select energy by pressing the [Energy Select] key on the equipment’s front
panel.
3. Place the conductive surface of paddle electrodes against the patient’s right
atrium and 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. Press the [Shock] key on the front panel.
Using internal paddles for synchronized cardioversion requires that the patient’
s ECG be acquired through a standard ECG cable. The patient’s ECG acquired
through the internal paddles may be unreliable for synchronized cardioversion
due to excessive noise or artifact causing inappropriate R-wave detection.
Insulating handle
Paddle electrode

5
INTERNAL PADDLES INSTRUCTIONS FOR USE
Note
zWhen internal paddles are used for debrillation, 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 eectively cleaned if
allowed to dry.
For more details, please refer to Appendix Reprocessing Instructions.

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INTERNAL PADDLES INSTRUCTIONS FOR USE
Continuity Check
To ensure quality operation of the internal paddles, perform the following test ev-
ery three months of normal use.
To Perform the test, follow this procedure:
1. Remove the 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
made between the test probes and the test points.
Pin A to Electrode 2: < 1 ohm
Pin B to Electrode 1: < 1 ohm
Pin 1 to Pin 2: 4.1 kΩ to 4.6 kΩ
Caution
zThe internal paddles must be sterilized at the completion of the continuity
check.

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INTERNAL PADDLES INSTRUCTIONS FOR USE
Symbols
Refer to instruction manual/ booklet
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
Not made with natural rubber latex.
Batch code
Authorized representative in the European community
Serial number
Date of manufacture
Manufacturer
Rx Only Federal law (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 45ºC
Storage temperature: -30 to 70ºC
Operating humidity: 10% to 95%, non-condensation
Storage humidity: 10% to 95%, non-condensation
Operating altitude: -381m to + 4575 m (106.2kPa to 57kPa)
Storage altitude: -381m to + 4575 m (106.2kPa to 57kPa)
Standard
The equipment meets the requirements of IEC 60601-1-2.

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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:
zReusable internal paddles including three dierent types which are with coated
spoons of 1-inch, 2-inch and 3-inch diameters respectively.
Warnings
zStainless steel spoons could be damaged by acidic detergents
and solutions. Do not soak in NaCl solution to avoid corrosion.
zPlease observe the information and user instructions
provided by the manufacturers of washer-disinfector,
sterilizer and the detergent.
zOpen the package just before the use to avoid the sterilized
internal paddles being contaminated.
zCheck the wrap before use. Remove the internal paddles from
use in case that package is damaged.
zUse 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.

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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:
zDo not use a fixating detergent or hot water (>40℃) as this
can cause the fixation of residua which may inuence 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.

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INTERNAL PADDLES INSTRUCTIONS FOR USE
Automated
cleaning and
disinfection
method
Set the program according to washer-disinfector manufacturer’
s instruction and add appropriate volume of cleaning detergent
at a concentration of 0.5% into the chamber according to the
instruction of cleaning detergent.
zWashing at 55℃for 5 minutes.
zRinsing with running water for 1 minute.
zRinsing with running water for 2 minutes.
zRinsing with de-ionized water at 93℃for 5 minutes.
Manual drying After cleaning, dry the product in the oven at 99℃for 15
minutes.
Automated
drying
After cleaning, dry the product in the oven at 99℃for 15
minutes.
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 without
stressing the seals.
If other standard packaging material would be used, use the
recommended method and parameters oered by the package
supplier.
Sterilization
Mindray has tested and approved internal paddles: 1-inch
internal paddles, 2-inch internal paddles and 3-inch internal
paddles for material compatibility and sterilization efficacy up to
50 cycles of moist heat sterilization, wrapped using the following
parameters.
Parameters Value
Sterilization Temperature 134℃
Exposure time 20 minutes
Dry time Up to 30 minutes
When sterilizing multiple instruments in one cycle, ensure that
the sterilizer’s maximum load is not exceeded.

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INTERNAL PADDLES INSTRUCTIONS FOR USE
Storage
Store the product in a dry, clean, and dust-free environment at
moderate temperature.
Store the packed internal paddles as directed by the instructions
on the package.
Reprocessing
validation study
information
The following test instructions, 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 Peelable Gussetted Pouch,
360mm×60mm×500mm AMCOR
FLEXIBLES SPS
Sterilizer 5075ELV, TUTTNAUER
Additional
information
If the above-mentioned chemicals and machines are not
available, the user is obliged to validate his procedure
accordingly.
Manufacture
contact See the backcover of this manual.

www.mindray.com
Mindray Building, Keji 12th Road South, High-tech Industrial Park,
Nanshan, Shenzhen 518057, P.R. China
Tel:[phone]
Fax:[phone]
E-mail: [email protected].cn
深圳迈瑞生物医疗电子股份有限公司
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电话：
[phone]
传真：
[phone]
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046-004615-00(4.0)
1639