Weinmann Meducore Easy Service manual

MEDUCORE Easy
Automatic external defibrillator Device nos. 1000 to 1340 from device no. 1341 with ILCOR 2005
MEDUCORE Easy
MEDUCORE Easy
Service and Repair instructions
with Battery-Pack
with Rechargeable Battery-Pack
Contents
Introduction
1.
Overview
2.
Description of Equipment
2.1
2.2
2.3
2.4
3.
Cleaning and disinfecting instructions
4.
Checking the device
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
5.
Maintenance
5.1
5.2
5.3
5.4
6.
Safety related check according to
§6 Medicinal products and Users ordinance .
6.1
6.2
6.3
6.4
6.5
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Intended use Scope of application User qualification Functional description
Testing parts needed Preparations for testing Entering the device data Checking the devices self testing Checking the volume levels Testing the ECG detection, current input,
shock button and shock output Checking the procedure display
and capacitor discharge Checking the info-button
and reading contact Checking the status LEDs Checking the condition of the exterior,
the equipment and the accessories Checking the IRDA interface and the
software version Checking the maintenance and safety
related check (SRC) stickers Preparing a device for dispatch
following repair Documentation
Intervals Check the Battery/Rechargeable Battery. Renew maintenance sticker Disposal
General Execution Testing devices Replace SRC sticker Documentation
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7.
Malfunctions and Rectification
8.
Repair information and repair instructions
8.1
General
8.2
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13. Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Tools and facilities
8.3
Discharge high voltage capacitor and open up device
8.4
Opening the device
8.5
Exchange the device lids
8.6
Close the device
8.7
Exchanging the capacitor
8.8
Replace the Real Time Clock batteries
8.9
Replacing the main circuit board
8.10
Exchanging pad plug cable
8.11
Exchanging the speaker
8.12
Exchange encasing, upper part
8.13
Exchanging encasing, lower part
Replacement parts
Tools and testing devices
10.1
General tools
10.2
Special tools
10.3
Software
10.4
Testing devices
Technical data
Technical Changes
12.1 Device: MEDUCORE Easy . . . . . . . . 43
12.2 Software . . . . . . . . . . . . . . . . . . . . 43
13.1 Repairs and maintenance protocol . . . . 44
13.2 Test record "Safety related check in accordance with §6 of the MP BetreibV (German Medicinal Products and Users
Ordinance)". . . . . . . . . . . . . . . . . . . 45
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© Copyright WEINMANN GmbH & Co. KG. The content and presentation are copyright protected and may only be used by authorised WEINMANN Service Partners in the course of their service operations. The content must not be reproduced or passed on to third parties. The complete documents must be returned on termination of the cooperation with WEINMANN.
2

Introduction

WEINMANN has been developing, manufacturing and marketing emergency medical devices for oxygen and inhalation therapy for decades.
The aim of this service and repair manual is to bring you to an expert level on the MEDUCORE Easy, allowing you to understand the operation, technology and repairs of the device. In combination with the training, that you have already completed for WEINMANN, you now belong to the “trained, informed, experts”, thereby allowing you to give your customers professional help and repair malfunctions independently and in accordance with the operation manual illustrated you have the possibility of making functional checks and if necessary carrying out repairs as shown in the service and repair manual.
In case of warranty claims all devices are to be sent to WEINMANN.
In order to handle warranty or goodwill requests we will require you to submit proof of purchase (invoice) of the customer.
Repair and maintenance work must be performed by WEINMANN or knowledgeable, well trained specialists.
They are responsible for all repairs carried out and all associated warranties!
When performing maintenance, only genuine
WEINMANN replacement parts ought to be used.
Please consider: Your customers puts trust in your capabilities just as much as you trust in WEINMANN.
Note:
Please use the operation manual for the following information about MEDUCORE Easy:
Safety instructions
Preparing the device for use
Operation
Cleaning and disinfecting while in use
Warranty
Please note that the operation of devices with and without ILCOR 2005 is different.
Introduction 3

1. Overview

1 Info-button
11 Display:
Shock preperation
10 Shock key
9 Carrying handle
8 LEDs
2 Device lid
3 Display field: “Stand clear of
the patient!”
4 Display field: “You can now
touch the patient“
5 Socket for electrode plug
6 Infra red interface
7 Loudspeaker
Underside of device:
12 Battery compartment
16 Self sticking
defibrillation electrodes
Underside of device:
13 Maintenance sticker
14 SRC sticker
(only in Germany)
17 Battery-Pack/
Rechargeable Battery-Pack (optional)
18 Battery charger
15 Device plaque
(only in Rechargeable-Pack model)
4 Overview
19 Emergency set 20 CD-ROM with software EasyView

2. Description of Equipment

2.1 Intended use

The MEDUCORE Easy is an automatic external defibrillator (AED). It has been devised to assist the user in the resuscitation of patients who show symptoms of acute cardiovascular arrest (pulseless ventricular tachycardia pVT or ventricular fibrillation VF).
The MEDUCORE Easy guides the user through the resuscitation process with the help of acoustic and optical instructions. The device conducts an ECG analysis on patients and, if necessary, makes preparations for the delivery of an electric shock. The delivery of a shock is carried out directly by the user, after the device has prompted to do so.
Only use the device MEDUCORE Easy for the purposes described below.

2.2 Scope of application

2.3 User qualification

The MEDUCORE Easy has been devised for application in the heart/lung resuscitation (HLR) of patients from upwards of 20 kg body weight at the emergency’s location.
The MEDUCORE Easy may only be used by persons who hold documented proof of the following qualifications:
Training in fundamental, life saving emergency care including the application of automatic defibrillators.
Instructions for the application of the MEDUCORE Easy carried out by an WEINMANN authorized person.
Description of Equipment 5

2.4 Functional description

The MEDUCORE Easy is compact, light and ergonomic. The acoustic and optical user instructions make the operation of the device, to a great extent, self explanatory.
Persons with a nominal medical knowledge, after a short instruction, can therefore be in the position to operate a defibrillator in the case of a heart lung resuscitation.
Optical and acoustic userguide The acoustic and optical user instructions are made up
of display fields and spoken orders.
After opening the device lid the user is led by MEDUCORE Easy with the help of detailed spoken orders through a step by step resuscitation process. During this process a green and red display field light up, indicating in which phase of the resuscitation the patient may be touched or not touched (traffic light principle).
Metronome function (only for devices with ILCOR 2005)
An activated metronome function gives off an acoustic metronome signal at a frequency of 100 beats per minute during the HLR-pause. Carry out the cardiac massage in rhythm with audible signal tone.
After 30 signal tones a spoken announcement is issued “Give 2 breaths now” You will now have time to carry out 2 respiratory sequences, before “Give 30 chest compressions now” is announced and 30 signal tones are given.
This ordered sequence repeats itself, until the HLR pause comes to an end and the red display field (“Stand clear of the patient”) lights up.
If the info button is pressed during the HLR pause, the info announcement is made. The metronome continues to run in the background but without an audible tone.
ECG-recording and analysis As soon as the electrodes are placed on the bare
upper body of the patient, the device will automatically begin with the recording and analysis of the ECG. The ECG recording and analysis will continue until the electrodes are removed from the patient or as soon as the lid of the MEDUCORE Easy is closed, which results in the device being switched off.
6 Description of Equipment
Defibrillation If the ECG analysis indicates defibrillation (pulseless
ventricular tachycardia pVT or ventricular fibrillation VF), the MEDUCORE Easy prepares to deliver a shock. Afterwards the device instructs the user to administer a shock.
For other heart rhythms, the device informs the user that they should carry out a heart-lung revival.
Application documentation The MEDUCORE Easy saves ECG and event data.
The data could later be used e.g. in the follow-up of treatment. For this, use the documentation and configurations software EasyView.
Self testing The MEDUCORE Easy initiates a self test at regular
intervals and after every time it is switched on. The device status is shown via light diodes on its front side. Self test results can be requested via the documentation and configuration software EasyView and saved onto a PC.
Description of Equipment 7

3. Cleaning and disinfecting instructions

Warning!
The Battery/Rechargeable Battery Pack must be removed from MEDUCORE Easy before cleaning.
Never immerse the MEDUCORE Easy in any disinfectant or any other liquid. Only carry out disinfection by wiping over the surface. This can otherwise lead to damage of the device and consequently endanger users and patients.
The MEDUCORE Easy can be kept properly clean by simply wiping to disinfect. Please observe the users instruction for the disinfectant selected. We recommend that you wear suitable gloves when disinfecting the equipment (e.g. household or disposable gloves).
We recommend that you use TERRALIN disinfectant, which is available from the Schülke & Mayr Company, Robert-Koch-Str. 2, D-22851 Norderstedt (Internet: www.schuelkemayr.de).
8 Cleaning and disinfecting instructions

4. Checking the device

Important! The device must undergo the following tests after every repair and every maintenance according to WM 40006, and the results must be entered into the test records. Additionally the test can be used for fault finding in the device.
If you detect errors or deviations from defined values in the course of your final testing you must not redeploy MEDUCORE Easy before these errors have been eliminated.
You can determine possible causes of such errors and recommended countermeasures by referring to chapter "7. Malfunctions and Rectification" on page 22.
We recommend that you generally keep the following ready for use:
Emergency-Set WM 15460
Battery-Pack WM 40155
Rechargeable Battery-Pack WM 40150

4.1 Testing parts needed

Electrodes, packed WM 40116
Important! The electrodes have a limited shelf life. Please make a note of the expiry date on the packaging.
Fully charged Rechargeable battery Pack or Battery-Pack
Defibrillator-Tester (see also 10.4, page 38)
IR-Adapter WM 22498
PC with installed software EasyView WM 40192
Multimeter, Measuring range up to 20 A
Battery adapter WM 40008
Test line MEDUCORE Easy WM 40454
Checking the device 9

4.2 Preparations for testing

EasyView
EasyView-Service
1. Boot up PC.
2. Start the PC software.
Overview of software versions:
EasyView
Reading, editing and saving usage data, modifying device settings.
EasyView-Service
Works like EasyView, facility for programming the serial number.
EasyView-Light
Works like EasyView; device settings cannot be modified.
EasyView-Light

4.3 Entering the device data

Enter the serial number of the device (Device-No.) and the manufacturing date into the test records.

4.4 Checking the devices self testing

1. Insert rechargeable or Battery-Pack.
2. Open the device lid.
3. Close the device lid.
Request:
– The device is giving off a short double peeping
tone. – All LEDs light up briefly. – The device announces clearly and completely
the spoken order “This device will assist you.”. – The green status LED lights up.
10 Checking the device

4.5 Checking the volume levels

1. Ensure that the volume setting is on "automatic". To do so, connect the device to EasyView and cor-
Microphone
rect the setting if necessary.
2. Open the device lid.
3. Create a sound directly over the microphone of the MEDUCORE Easy, by scratching on the en­casing for example.
The microphone in the MEDUCORE Easy can be found between the analysis triangle and pentagon.
Request:
– The volume of the repeated and clearly spoken
order increases.

4.6 Testing the ECG detection, current input, shock button and shock output

Preparation of the MEDUCORE Easy
1. Connect the rechargeable battery adapter, cur­rent measuring device and rechargeable battery or battery pack as illustrated.
2. Install the rechargeable battery adapter in the MEDUCORE Easy.
Preparation of the defibrillator tester The defibrillator tester emulates a patient impedance
of 50 .
1. Connect MEDUCORE Easy test line WM 40454 to the defibrillator tester as illustrated.
2. Connect the defibrillator tester to a power supply (battery or mains plug).
3. Switch on the defibrillator tester (sliding switch POWER in position I).
ENRG SYNC PEAK WAVE more
Main Menu 1
A self-test is performed. The main menu appears in the display (Main Menu 1).
Checking the device 11
Energy --- J WAV> ECG90 PLAY HDR esc
4. Press the arrow button under ENERG.
The indicator for the Energy Modus appears in the display.
Energy --- J WAV> VFIB PLAY HDR esc
button under WAV until VFIB appears in the display.
Performing the test 1. Open the lid of the device.
2. Plug the defibrillator tester electrode plug into the device.
Requirement:
– The device detects ventricular fibrillation and
after a maximum of 10 sec clearly gives the spoken message "Shock required".
3. The device prepares to give the shock.
Requirement:
– The current consumption of the device is be-
tween 6 A and 12 A.
4. Note the current consumption in the test report.
5. After the spoken message: "Press the flashing shock key", activate this.
Requirement:
– The shock is triggered by activation of the
shock button.
– The shock is given. The device clearly gives the
spoken message "Shock was delivered".
5. To simulate venticular fibrillation: Press the arrow
Energy 162 J WAV> VFIB PLAY HDR esc
– The energy discharged is between
168 J ± 10 % (Low Energy). The value is shown in the display of the defibrillator tester.
Note: Only the testing of the "Low Energy" shock is necessary. If it is also required to test the "High Energy", the energy must be 298 J ± 10 %. In this case, ventricular fibrillation must be set on the defibrillator tester as described above. Return to the main menu via esc.

4.7 Checking the procedure display and capacitor discharge

Note: Do not press the shock key during this test!
1. Simulate ventricular fibrillation with the defibrilla­tor-tester (Signal Vfib).
12 Checking the device
2. The device makes a clear spoken order “Stand clear of the patient” and “Analyzing”.
Request:
– All of the LEDs in the red triangle light up. – The device continues to give spoken orders,
during which all the LEDs on the shock key arrow are lit up in red.
– All of the LEDs around the shock key flash red.
3. After approx. 15 seconds it is announced that “Shock was not delivered”.
Request:
– The capacitor is discharged with an audible
sound.
4. Simulate f = 60 bpm with the defibrillator-tester Sinus EKG.
Request:
– All of the LEDs in the green pentagon light up.

4.8 Checking the info-button and reading contact

Info-button

4.9 Checking the status LEDs

1. While the green pentagon is lit up, press the info­button.
Request:
– The device announces a spoken order similar
to “Device has been in use for…in total 1 shock since device startup”.
2. Pull the electrode plug out of the device.
3. Close the device lid.
Request:
– The device cuts short any spoken order,
extinguishes all process LED lights and leaves only the green status LED blinking.
– No new spoken order is made.
Open the device lid to turn the device on.
Request:
– All of the three Status-LEDs, (red, green, yellow)
light up.
Checking the device 13

4.10 Checking the condition of the exterior, the equipment and the accessories

1. Firstly, carry out a visual test of everything.
Requests:
Encasing
– Encasing not scratched and without blemishes – Encasing completely screwed on – Front film and sticker stuck down firmly and
correctly on the lid – Labelling OK? – The loudspeaker opening is free from dirt.
Electrode connection
– Undamaged – In working order
Push buttons
– Undamaged – Working correctly
Lid
– Lid not scratched and without blemishes – Lid is correctly attached, easy to open and
closes firmly – Functions open, close, switch on are ok.
Inner part
– The socket for the electrode plug is free from
dirt.
Rechargeable Battery-Pack
– Completely charged
Battery-Pack
– Check expiry date (see device sign Battery-
Pack). Insert new Battery-Pack if necessary. – If the expiry date is not yet reached, then check
the level of charging. Insert battery, open and
close device lid. The green LED must flash; the
yellow LED should not flash.
If these parts have been delivered, check:
14 Checking the device
Defibrillation electrodes WM 40116 available. Check expiry date, if necessary replace.
Rechargeable Battery-Pack WM 40150 available.
Battery-Pack WM 40155 available.
Emergency set WM 15460 available.

4.11 Checking the IRDA interface and the software version

1. Check that the interface is working correctly by retrieving the device data.
Request:
All the device data are displayed.
2. Ensure that a PCB with the latest device software is installed in the device. This can be done by comparing the software version displayed with table (see "12.2 Software" on page 43).
If the software version is no longer current, replace the PCB with an up-to-date one as described in section 8.9 and enter the device number as described.

4.12 Checking the maintenance and safety related check (SRC) stickers

Check that the maintenance and SRC stickers are affixed correctly (SRC sticker applies only to Germany). If repairs have been carried out, then you should replace the stickers with new ones.

4.13 Preparing a device for dispatch following repair

Conditions The Programme EasyView must be started up and
the PC infrared interface or the infrared adapter must be aligned with the infrared interface of the MEDUCORE Easy (see chapter “Operation” in the PC-software operating instructions EasyView WM 16880).
Execution 1. Insert Rechargeable Battery or Battery-Pack.
2. Open the device lid.
3. Read off the charge status of the battery pack and compare it with the value specified in the test record.
Depending on the Battery-Pack capacity displayed proceed as follows:
• Capacity is > 50%:
– The Battery-Pack is OK.
• Capacity is < 50%:
– Inform your customer about the charging
level.
Checking the device 15
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