Mindray MR6501 Manual de usuario

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Internal Debrillation Paddles

Instructions for Use

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.

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.

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.

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.

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.

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

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.

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.

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.

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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