Service Manual
67 Pages
Preview
Page 1
FRED EASYPORT
Revision history of the service manual
Version 01.00:
0-48-0019
April 2004
Page I
APRIL 2004
FRED EASYPORT
WARNING This manual shall be considered to form an integral part of the device described. This technical manual is intended for qualified personnel and describes the operating, maintenance and troubleshooting procedures for FRED® EASYPORT. Compliance with its content is a prerequisite for proper device performance and for the safety of the patient and operator. The manufacturer shall only be liable for the safety, reliability and performance of the device if: - assembly, extensions, adjustments, modifications or repairs are performed by the manufacturer or by persons authorised by the manufacturer. - the electrical installation of the facility of use complies with the requirements applicable in the country. - the device is used in accordance with its instructions for use. - the spare parts used are original parts from SCHILLER. This manual describes the device at the time of printing. The supply of this manual does not in any event constitute permission or approval to modify or repair a device. The manufacturer agrees to supply all the spare parts for a period of ten years. All rights reserved for the devices, circuits, processes and names appearing in this manual. The FRED EASY device shall be used as described in the User’s Manual. The device may not be used for any purpose that has not been specifically described in the manual, as such use could be hazardous.
0-48-0019
Page II
APRIL 2004
FRED EASYPORT
SAFETY INFORMATION
·
The product is marked as follows:
CE- 0459 in accordance with the requirements of Council Directive 93/42/EEC relating to medical equipment, based on the essential requirements of annex I of the directive. ·
It fully meets the electromagnetic compatibility requirements of standard IEC 60601-1-2 / IEC 60601-2-4 “Electromagnetic compatibility of medical electrical devices”.
·
The device has undergone interference suppression in accordance with the requirements of standard EN 50011, class B.
·
In order to optimise patient safety, electromagnetic compatibility, accurate measurement indication and proper device performance, users are advised to use only original spare parts supplied by SCHILLER. Any use of accessories other than original accessories shall be at the exclusive risk of the user. The manufacturer shall not be liable for any damage due to the use of incompatible accessories or consumable supplies.
·
The manufacturer shall only be liable for the safety, reliability and performance of the device if: - assembly, configuration, modifications, extensions or repairs are made by personnel from SCHILLER MEDICAL or personnel duly authorised by SCHILLER MEDICAL. - the device is used in accordance with its instructions for use.
·
Any use of the device other than as described in the instructions for use shall be made at the exclusive risk of the user.
·
This manual covers the device version and the safety standards applicable at the time of printing. All rights reserved for the circuits, processes, names, software and devices appearing in this manual.
·
The quality assurance system in use in the facilities of SCHILLER meets international standards EN ISO 9001 and ISO 13485.
·
Unless otherwise agreed in writing by SCHILLER, no part of the manufacturer’s literature may be duplicated or reproduced.
0-48-0019
Page III
APRIL 2004
FRED EASYPORT
Safety symbols used on the device
Danger! High voltage
Conventions used in the manual
G
Danger:
indicates an imminent hazard which, if not avoided, will result in death or serious injury to the user (and/or others).
I
Caution:
Warning indicating conditions or actions that could lead to device or software malfunctioning.
Note:
Useful information for more effective and operation.
F
practical device
Additional information or explanation relating to the paragraphs preceding the note.
Manufacturer: SCHILLER MEDICAL 4, rue Louis Pasteur ZAE sud F- 67 162 Wissembourg Tel. Fax
: **33 / (0) 3.88.63.36.00 : **33 / (0) 3.88.94.12.82
0-48-0019
Page IV
APRIL 2004
FRED EASYPORT
PRECAUTIONS WHILE TESTING THE DEVICE
While testing the FRED® EASYPORT defibrillator, the patient may only be simulated with fixed highvoltage and high-power resistors that are well insulated from the ground or earth. Poorly insulated devices or devices with loose contacts or devices containing components such as spark arresters or electronic flash lamps may never be used as they could irremediably destroy the device.
0-48-0019
Page V
APRIL 2004
FRED EASYPORT SOMMAIRE
1.
Operation_________________________________________________________ 1-1 1.1 1.2 1.3 1.4 1.5 1.6 1.7
2.
Display and controls _____________________________________________________ 1-1 Battery and minicard. ____________________________________________________ 1-2 Explanation of symbols used ______________________________________________ 1-3 Device operation. _______________________________________________________ 1-4 Defibrillation procedure ___________________________________________________ 1-6 Recording (optional) _____________________________________________________ 1-8 Technical specifications __________________________________________________ 1-9
Testing and maintenance ____________________________________________ 2-1 2.1 2.2 2.3 2.4 2.5
Functional testing _______________________________________________________ 2-1 Test mode: ____________________________________________________________ 2-1 SAAD mode ___________________________________________________________ 2-2 Systematic checking before use ____________________________________________ 2-4 Cleaning and disinfection _________________________________________________ 2-4
3.
Troubleshooting____________________________________________________ 3-1
4.
Replacement of parts _______________________________________________ 4-4 4.1 4.2 4.3 4.4 4.5 4.6
5.
Device disassembly procedure _____________________________________________ 4-5 Working on the CPU circuit________________________________________________ 4-6 Working on the defibrillator circuit___________________________________________ 4-8 Replacing the HV capacitor________________________________________________ 4-9 Reassembling the device ________________________________________________ 4-10 Replacing parts ________________________________________________________ 4-10
Technical description of boards_______________________________________ 5-12 5.1 FRED® Easyport_______________________________________________________ 5-12 5.2 CPU, part no. 3.2627 ___________________________________________________ 5-13 5.3 Defibrillator board, part no. 3.2628 _________________________________________ 5-31
6.
Device modifications ________________________________________________ 6-1 6.1 Definition ______________________________________________________________ 6-1 6.2 CPU circuit ____________________________________________________________ 6-1 6.3 Defibrillator circuit _______________________________________________________ 6-1
7.
Diagrams and layout drawings ________________________________________ 7-1 7.1 CPU circuit 3.2627 ______________________________________________________ 7-1 7.2 Defibrillator circuit 3.2628 _________________________________________________ 7-3
0-48-0019
Page VI
APRIL 2004
Operation
1. Operation This section briefly outlines the operating of the device. For more detailed information, please refer to the User’s Manual. 1.1
1 2 3 4 5 6
Display and controls
Green key to switch the device on and off (to stop supporting more than 3 seconds). The yellow indicator lamp flashes as long as the electrodes are not in place. Connection of adhesive electrodes Display Blue key to start analysing Key for triggering the defibrillation shock
0-48-0049
Page 1-1
Avril 2004
Operation
1.2
7 8 9
Battery and minicard.
Battery 12 V SD-Minicard protection. SD-Minicard
0-48-0049
Page 1-2
Avril 2004
Operation
1.3
Explanation of symbols used Symbols on the device or accessories BF type signal input, protected from defibrillation Caution! High voltage! Expiry date for the use of defibrillation electrodes Follow the instructions for use
Open the electrode packaging
Remove the protective film
Single use only. Do not reuse.
Do not fold the packaging
Storage temperature range
Symbols displayed on the screen Number of shocks given since starting up Battery weak (not flickering) 24%
Memorizing in progress with % progressively incremented with the filling (not flickering)
99%
Almost full memory, threshold with 98% filling (flickering) Problem memory card
Adult electrode detected
Child electrode detected
Time since the machine was started up (minutes and seconds)
0-48-0049
Page 1-3
Avril 2004
Operation
1.4
Device operation.
FRED® Easyport is programmed to operate in four different modes – the test mode followed by the defibrillator mode, the SAAD mode for device configuration and the Standalone mode, used by Manufacturing. ·
Test mode When the device is powered by a cell, it runs a self test every time it is started up. If it does not find any fault and is ready to operate, it switches to the Defibrillator mode.
·
Defibrillator mode (or Nominal mode) When the device is powered by a cell and has passed the self tests, it switches to the defibrillator mode. In this operating mode, the device performs the following operations: - Resuscitation algorithm (ERC protocol). - Saving of data throughout the procedure - Monitoring of system and physiological parameters Illustration of the screen in nominal mode Date and time
15/01/04 16:54
24% ECG trace
PRESS THE GREEN BUTTON
Messages
·
SAAD (Setup, Acquisition, Adjustment, Downloading) mode When the device is powered by an adapter unit connected to the FredCo software by means of the serial link and is switched on, it goes into SAAD mode. This mode is used to: - Set up and adjust the device - View statistics - View logs (events describing the use of the device) - Download new software versions
·
Standalone mode (Manufacturing) This mode is specific to the manufacturing department of Schiller and is used to test the CPU board by itself. Connector P1 of the CPU board must be connected to the serial link of a test console and pin 4 of P1 must be connected to the ground. When the device is in Standalone mode, a message is displayed to inform the operator that the device is not ready for defibrillation. Pressing the keys has no effect, including the On/Off button.
0-48-0049
Page 1-4
Avril 2004
Operation Diagram of the operating modes
External power + Pin at ground
Power ON External power Battery power
STANDALONE Modus
TEST Modus
C.A.R.T. Modus
Test without errors
DEFIBRILLATOR Modus
In the Defibrillator mode (or nominal mode), FRED® Easyport is a cell-operated automated external defibrillator that provides biphasic defibrillation waveforms. Defibrillation is done by means of disposable adhesive electrodes through which the ECG signals required for the analysis are also collected. Adhesive electrodes are available in child and adult versions. The device recognises the type of electrode applied and selects the appropriate defibrillation energy levels accordingly. When the electrodes are not connected, the device displays a message to inform the user that the electrodes are not connected or are poorly connected and that they need to be connected to the device. The device remains in that state as long as the electrode problem persists. If the problem lasts for 30 seconds, the device guides the user to apply CPR. After five minutes, the device goes off automatically to save power. The fault is also reported by a second visual indicator, a LED located under the electrode connector. When the fault is observed, the LED lights up to report it. Otherwise, the LED is off. To use the device, the user is given visual and audio instructions (display and loudspeaker). Power is supplied by disposable plug-in lithium cells. Their capacity is sufficient for - 70 shocks at the maximum power value or - five hours of monitoring (cyclical, 30 minutes on, 30 minutes off) or - five years of standing by.
0-48-0049
Page 1-5
Avril 2004
Operation
1.5
Defibrillation procedure
All the stages are explained to the user through voice prompts and are displayed on the screen. When the key is pressed, an introductory text asks the user to stick on the electrodes. The introductory text is repeated till FRED® Easyport recognises that the adhesive electrodes have been applied. After that, FRED® Easyport asks the user to start an ECG analysis and not touch the patient.
Note - With the signals from the database of the AHA (American Heart Association), FRED® Easyport offers precise detection with 98.4 % sensitivity and 99.8% specificity. - The device can be set up so that it automatically starts an ECG analysis. During the analysis phase, the software controls the capacitor charge with an energy value equal to that of the first shock. If the analysis program recognises a heart rate that calls for defibrillation, the device asks for a shock. The heart disorders that call for defibrillation are: - ventricular fibrillation or - ventricular tachycardia with a rate of over 180 bpm. If the device recognises a heart rate that calls for defibrillation, defibrillation is only permitted if the patient has been found earlier to have no pulse or show no signs of circulation. A second analysis is triggered automatically with a preliminary capacitor charge to the energy value of the first shock. If the first defibrillation shock has no effect, the device automatically tops up the charge in the capacitor to the energy required for a second shock. A third analysis is triggered automatically with a preliminary capacitor charge to the energy value of the second shock. If the second defibrillation shock has no effect, the device automatically tops up the charge in the capacitor to the energy required for a third shock. Note The energy values set by default as follows (the technical assistance department of Schiller can set other default values). Shock Adult Child 1 90 J 15 J 2 90 J 30 J 3 120 J 50 J If the third shock has no effect, FRED® Easyport asks the user to alternately apply artificial respiration and heart massage. After one minute, it will recommend a ECG analysis. Depending on the set-up, the new analysis may be automatic. After a successful defibrillation shock, FRED® Easyport asks the user to check the respiration and blood circulation of the patient. If there are no signs of circulation, the device recommends the alternate application of artificial respiration and heart message. If there are signs of circulation, the patient is to be laid on his or her side.
0-48-0049
Page 1-6
Avril 2004
Operation If the analysis program does not recognise a heart rate that calls for defibrillation: - FRED® Easyport informs the user that no defibrillation shock is required, and - asks the user to check respiration and signs of circulation If there is no sign of circulation, FRED® Easyport asks the user to alternately apply artificial respiration and heart massage. If there are signs of circulation, the user is asked to lay the patient on his or her side. After a minute, FRED® Easyport will ask for an ECG analysis once again. Depending on the set-up, the new analysis may be automatic. The values below may be set up by the technical assistance department of Schiller: - upon starting up: introductory text or immediate request to apply the adhesive electrodes - voice volume - energy levels of shocks 1, 2 and 3, with a distinction between adult and child values - starting of the ECG analysis by pressing the keyboard or automatic Procedure chart
0-48-0049
Page 1-7
Avril 2004
Operation
1.6
Recording (optional)
For information, the memory card can save: - half an hour of ECG - 500 events relating to the procedure (see overview opposite). In the nominal operating mode, the device records different types of information throughout the procedure. Recording starts when the device is powered up and runs in the nominal mode and stops when the device is switched off. 24%
·
This symbol is displayed (steady display) and the Saving in progress indicator. percentage is incremented as the memory card is filled up.
·
This symbol flashes when the recording memory is Memory almost full indicator. almost full. That does not stop the ERC protocol. The limit at which the memory is almost full is 98 %.
·
Memory full or no card indicator. No memory symbol is displayed.
·
This symbol flashes when the Indicator of a problem with the procedure recording memory. recording memory is not accessible (write protected, hot insertion, electronic problem etc.). That does not stop the ERC protocol.
99%
0-48-0049
Page 1-8
Avril 2004
Operation
1.7
Technical specifications
·
Form of the defibrillation pulse - Biphasic impulse of defibrillation pulsated with compensation of patient impedance.
·
Standard energy settings:: - Adult (discharge in 50 Ω) : 90 -90 -120 J - Child (automatic switch when child electrodes are connected) : 15 -30 -50 J - The energy levels can be configured by the technical assistance department of Schiller if the standard values need to be changed : 15 - 30 - 50 - 70 - 90 - 120 J (Adult) 15 - 30 - 50 - 70 (Child) - Tolerance at 50 Ω: ± 3 J or ± 15 % (whichever is greater). 100 25 W 80
50 W
120 J
75 W 60
100 W 125 W
current (A)
40
20
0 150 W
200 W
-20 175 W -40
0
1
2
3
4
5
6
7
8
9
time (ms)
·
Automatic charge control after a shock is recommended following an analysis
·
Patient resistance 30 to 200 Ω.
·
Charge duration, from the time a shock is recommended up to the time when the device is ready: < 10 s
·
Cycle time between two shocks: < 20 s
·
Indication that the devices is ready to deliver a shock: key
·
The shock is delivered with key
·
Internal safety discharge: - after the self test phase of the defibrillator circuit - if the CPU host selects a 0-J energy value - if the PIC detects that the cell is low during the charge phase (UBATT £ 7,5V) - if the energy stored during the hold phase does not match the energy selected - when the device is switched off or when the cell is removed during operation
·
The shock is delivered positions
·
BF type defibrillation electrode connector.
0-48-0049
goes on.
with single-use adhesive electrodes applied in the anterior / anterior-lateral
Page 1-9
Avril 2004
Operation ·
Defibrillation electrodes: - Adult electrodes: Active area 50 cm² - Child electrodes: Active area 15 cm² - Electrode cable length: 1,20 m
·
VT / VF recognition: - Shock recommendation: for VF and VT (VT > 180 bpm) - Sensitivity: 98.4 % Specificity: 99.8 %. These values have been found with the AHA database, which contains cases of VF and VT with and without artefacts. - Conditions required for ECG analysis: Minimum amplitude for the signals used > 0.15 mV , signals of < 0.15 mV are considered to show asystole. - Definition: Sensitivity: Correct detection of heart rates for which defibrillation shocks are recommended Specificity: Correct detection of heart rates for which defibrillation shocks are not recommended
·
Display: - LCD, 60 x 40 mm, high definition, with EL backlighting, display of text and icons
·
Recording of the use of the device (optional) - ECG recording (half an hour) - Event recording (500 events)
·
Capacité de la pile au lithium - 70 chocs à puissance maximale ou - Utilisation du moniteur pendant 4 heures (cyclique 30 minutes en marche, 30 min arrêté) - 5 ans de veille. Lithium battery capacity - 70 shocks at the maximum power rating or - Use of the monitor for four hours (cyclical, 30 minutes on, 30 minutes off) - Five years standing by.
·
·
Environment conditions: - Transport / storage: Temperature - 20 to + 50 °C Relative humidity of air 0 to 95 %, non condensing Atmospheric pressure 500 - 1060 hPa - Use: Temperature 0 to + 50 °C Relative humidity of air 0 to 95 %, non condensing Atmospheric pressure 500 - 1060 hPa
·
Electromagnetic compatibility: - The FRED easy® device only uses radio frequency range energy for its internal functions. It is treated against interference in accordance with standard CISPR 11 class B - The FRED easy® device can be subjected to the following interference without any adverse effect on its functioning: v electrostatic discharges of up to 8 kV. v energy in the radio frequency range up to 20 V/m (80 - 2500 MHz, 5 Hz modulated). v magnetic fields of 100 A/m, 50 Hz
·
Dimensions and weight: - Width : 126 mm - Depth : 133 mm - Height : 35 mm - Approximate weight : 490 g (with battery)
0-48-0049
Page 1-10
Avril 2004
Testing and maintenance
2. Testing and maintenance This section describes the test and maintenance procedures recommended for pour FRED® Easyport.
2.1
Functional testing
Functional testing is performed by the automatic test function. In order to ensure that the device is operating correctly, tests are conducted when it is switched on in the nominal mode (SAD mode).
2.2
Test mode:
Self tests are conducted automatically when the device is powered by the cell and is switched on by pressing On/Off key. The operator does not see the tests. No message describing the tests is displayed when the the device is running them. A starting up screen is displayed during the self test procedure with the following information:
SCHILLER
EASYPORT
Sw CPU : V01.00B1 Sw Defi : V01.00B1 Hw CPU : 3 Hw Defi : 5 Language : 16 19/01/04 15:54 !!! TESTING !!!
Language Code 1
English
10
Finnish
19
Turkish
28
Walloon
2
French
11
Russian
20
Japanese
29
Latvian
3
German
12
Chinese
21
Hebrew
30
Tahitian
4
Spanish
13
Korean
22
Bulgarian
31
Brazilian
5
Italian
14
Romanian
23
Arabic
32
Slovak
6
Dutch
15
USA
24
Czechoslovakian
33
Polish
7
Swedish
16
Austrian
25
Quebec French
8
Portuguese
17
Danish
26
Hungarian
9
Norwegian
18
Greek
27
Flemish
0-48-0049
Page 2-1
Avril 2004
Testing and maintenance The tests cover the following functions:
1. Hardware number test 2. Acquisition system test: ECG & patient impedance 3. Defibrillator test: communication channel and defibrillation hardware module 4. Settings storage memory test 5. Real time device clock test 6. Cell voltage test. The cell voltage is tested by charging the capacitor 7. LCD display test 8. Voice prompt system test Note Failure to pass tests 1 – 4 disables the device, which indicates the failed test till it is switched off. Failure to pass tests 5 and 6 does not disable the device. Simultaneous failure to pass tests 7 and 8 disables the device.
If the tests are passed or if the errors are not of the disabling type, the device goes into Defibrillator mode.
2.3
SAAD mode
This operating mode is used to set up the device, extract statistics or download software. The cell is replaced by the adapter unit and the downloading unit connected to the FredCo software is to be used. 2.3.1
Setting up and adjustments
The configurable settings are: · · · · · · · · · · · · ·
Date and time + format + summer/winter time Ø Date format: DD/MM/YYYY or MM/DD/YYYY or YYYY/MM/DD Ø Time format: 12 or 24 hours Defibrillation energy values ECG display Voice prompt volume level Analyse button use CPR phase Motion detection Language for the display and audio messages of the ERC protocol Device serial number Hardware version number Shock counter (charge capacitor wear) ERC 1 minute / 3 minute protocol selection Device identification string
0-48-0049
Page 2-2
Avril 2004
Testing and maintenance 2.3.2
Statistics
The list of data stored below is not exhaustive and will develop to keep pace with needs: · · · · · · · ·
Total device running time Status of the mini SD card flash memory – card size, space occupied, number of events logged Periodic test log (last 30 tests as a minimum): date, time, result, description of the error Uncontrolled switching off (last 30 times as a minimum): cell low, electrode fault for more than 5 minutes – date and time Number of charges per energy value Number of shocks per energy value. Total running time of the high-voltage converter Etc.
The data cannot be erased by means of a device button. They may be erased by a command from the serial link. The data need to be made secure. In particular, they must not be destroyed when the device is switched off suddenly because the cell is removed. The data are only saved when the device undergoes a controlled shutdown. 2.3.3
Downloading
The downloading function is used to upgrade the firmware in the device. The software provides the language. To change languages, the firmware with the required language needs to be downloaded.
0-48-0049
Page 2-3
Avril 2004
Testing and maintenance
2.4
Systematic checking before use
Before each use, the device must undergo a visual inspection, including the cables, connectors and electrodes. If a fault or malfunctioning likely to harm the safety of the patient or the user is found, the device may not be started up again before it is repaired. Systematic inspection before each use · Device housing check · No mechanical damage · No liquid penetration into the device · Control button and connector check
2.5
Cleaning and disinfection
I
Important:
Switch off the device before cleaning. Remove the cell before starting to clean the device in order to ensure that the device does not start up accidentally. Before cleaning, also disconnect the defibrillation electrode cables from the device. No liquid must enter into the device. If that does happen, the device may not be used before it is checked by the aftersales service department.
Users are strongly advised against cleaning the devices or electrodes with agents such as ether, acetone, esters or aromatic chemicals. Never use phenol-based cleaners or cleaners containing peroxide derivatives to disinfect the surfaces of the device housing. · Systematically dispose of the single-use electrodes immediately after use in order to ensure that they are not reused by mistake (hospital waste). · Before cleaning the electrode cables, disconnect them from the device. Clean and disinfect them by wiping them with a piece of gauze moistened with cleaner or disinfectant. Never immerse the connectors in any liquid. Use any cleaning or disinfectant solution that is commonly used in hospitals. · Proceed likewise with the device housing, with a cloth moistened with cleaner or disinfectant. No liquid may enter the device during cleaning.
0-48-0049
Page 2-4
Avril 2004