Number : GUSATA051

Q.A. GUIDE

FRED EASY TEST

Indice : C
Page : 1/3
Modification date : 16/04/15

This guide has to be used together with the report sheet FRSATA051,
in order to perform the maintenance test (3 year, 6 year ...) or to perform the test after a repair.
Only fromSchiller autorized person/establishment can perform this test.

Version : Semiautomatic/Automatic - Ethernet/Online/SD card & Option : Manual Metronome - ECG display
VISUAL INSPECTION/ MECHANICS INSPECTION OF THE UNIT (for all versions) :
The unit must be turned off and the battery removed
1.Check the general aspect (specially damaged parts which can involve to tightness issues)
2.Check if the buttons are present and check their status
3.Check the labels (serial number, EC).
4.Shake the device and check if you hear any suspicious noise
5.Check the external screws aspect.
6.Check if the electrodes connector is clean and not deteriorated

VISUAL INSPECTION/ MECHANICS INSPECTION OF THE UNIT (for SD card version) :

7.Check if the rubber cover for the memory card is present.

WORKING CONTROL OF THE UNIT (for all versions) :

8.Insert a lithium cell (or a rechargeable battery), then check if the self-test progress is successful (versions indication and then
putting the device into standby position).
9.The device is standing by, the LED OK is blinking.
10.Switch on the device, the LED Electrode lights up.
11.Check if the timer indication is correct.
12.Check if the shock counter indication is correct
13.Check if the battery level indication is correct
14.Check if the memory card pictogram

and the filling percentage indication are present.

15.Connect the Adult electrodes connector check if the character A (for Adult mode ) or a pictogram representing an adult
is present on the upper right-hand corner of the screen. Connect the Child electrodes connector and then check if the character C
(for Child mode ) or a pictogram representing an child is present on the upper right-hand corner of the screen.

DEFIBRILLATOR FUNCTION INSPECTION :

16.Connect a simulator with NSR-signal (Normal Sinus Rhythm), the LED Electrode should be off .
17.If it's necessary push the green analysis button

, the result should be shock not recommended .

Connect a simulator with VF signal (Ventricular Fibrillation).

(A) for Semiautomatic version :

(B) for Automatic version :

18A.Push the analysis button (if it's necessary).After the analysis , a shock 18B.An automatic analysis is started, shock is
is recommanded and the shock
button is lighting up and the recommanded. Check if a warning about the imminent
shock appears after analysis.
message Press Orange Button appears.
19B.Check if the orange shock button blinks
19A.Disconnect the electrodes connector
Check if : the orange shock button switches off and the LED 20B.Disconnect the electrodes connector as soon as
Electrode lights up (+ internal discharge).
orange shock button blinks.
20A.Repeat 18th step, when Press Orange Button appears, wait 20 Check if the orange shock button switches off and
the LED Electrode lights up (+ internal discharge).
seconds 1 sec after the charging is done, (don't deliver the shock)
the shock button must switch off (internal discharge).
21B.Repeat steps 18B and 19B. After a 4 seconds
21A.Repeat step 18th step, when Press Orange Button appears,
deliver shock (deliver 3 shocks), use a Joulemeter (note the kind, the
management number and the deadline calibration) to check the 3
delivered energy values and if the delivered values correspond to the set
values. The values must imperatively be located between the tolerances
(setting value 15%). Use the following table to know nominal values
tolerances.

countdown the shock is delivered. Use a Joulemeter

(note the kind, the management number and the deadline
calibration) to check the 3 delivered energy values and
if the delivered values correspond to the set values. The
values must imperatively be located between the
tolerances (setting value 15%). Use the following table
to know nominal values tolerances.

Number : GUSATA051
Q.A. GUIDE

Indice : C
Page : 2/3
Modification date : 16/04/15

FRED EASY TEST

According to the international standard : IEC 60601-2-4
Tolerance +3J / +15%

11

18

34

57

80

103

126

149

172

Nominal Value J

15

30

50

70

90

110

130

150

Tolerance -3J / -15%

12

26

43

60

77

94

111

128

DATA TRANSFERT INSPECTION (Only for Ethernet, Online versions) :

(A) for Ethernet version : type 1

(B) for Ethernet version : type 2

(C) for Online version :

22A.Check if the rubber cover for 22B.Turn the unit off.

Ethernet connector is present.
Insert the Ethernet adapter into the
23A.Turn the unit off.
connector (see picture below) and connect the
Insert the Ethernet adapter into the unit to the server using an Ethernet cable.
connector (see picture below) and The unit will automatically be turned on and
connect the unit to the server using an enters into the data transmission mode.
Ethernet cable.
Check if the unit connects to the server
The unit will automatically be turned on (where LifeDataNet is installed) without
and enters into the data transmission error message.
mode. Check if the unit connects to the (It may be necessary to configure IP addresses
server (where LifeDataNet is installed)
using FredCo)
without error message.
Check if :
(It may be necessary to configure IP
23B.The LED (on the blue box) switches on
addresses using FredCo)
when the unit is turned on and blinks while
the device communicates with the server.
Check if :

22C.Turn the unit off.

Check if :
23C.The LED (on the blue box)
switches on when the unit is turned on
and
blinks
while
the
device
communicates with the server.

24A.Transmission automatically starts

and the transmitted data percentage is
displayed (this supposes that data are
stored in the memory card).

24B.Transmission automatically starts and

the transmitted data percentage is displayed
(this supposes that data are stored in the
memory card).

24C.Transmission automatically starts

and the transmitted data percentage is
displayed (this supposes that data are
stored in the memory card).

25A.You hear an audio signal and a

warning appears when transfer is done.

25B.You hear an audio signal and a warning 25C.The message Fred Easy Online
appears when transfer is done.
Ready appears.

Insert the unit in the wall mount

bracket (see picture below), the unit will
automatically be turned on and enters
into the data transmission mode.
Check if the unit connects to the server
(where LifeDataNet is installed) without
error message.
(It may be necessary to configure IP data
using FredCo)

26A.Remove Ethernet adapter, the device

26B.Remove Ethernet adapter, the device 26C.Remove device from docking
automatically switches off.
automatically switches off.
station, it automocatically switches off

OPTIONS INSPECTION :

Manual option :
Turn off the device for at least 5 minutes (to reset shock counter)

Turn on the device and, put it in manual mode : press simultaneously green and orange buttons (
prompted by a displayed message to press again both buttons. This must be done within 5 seconds.
Check if :
Connect an ECG simulator to the unit and check if you can see :
27. ECG waveform on the screen.
28.The selected energy and a prompt to push the green button.
Energy value Check :
Connect a Joulemeter (note the kind, the management number and the deadline calibration) to the unit.

). You will be

Number : GUSATA051
Q.A. GUIDE

Indice : C
Page : 3/3
Modification date : 16/04/15

FRED EASY TEST

29.Press on green button

to begin the charge of selected energy. When it's done, the orange button lights up and both a
voice prompt and a message ask you to deliver the shock (orange button).

Check if :
30.There is an internal discharge after 20 seconds 1 sec without delivering shock.
31.Repeat 29th step and deliver 3 shocks (by pressing on orange button
when unit asks it) using a Joulemeter to check the

delivered energies value. The values must imperatively be located between the tolerances (setting value 15%). Use the same
table than in steps 21A and 21B to know nominal values tolerances.
(To return to the semiautomatic mode, switch off the unit and leave it turned off for at least 5 minutes.)

Metronome option :
32.Check if the unit generates a steady beat during cardiopulmonary resuscitation (CPR) to give the frequency for chest

compressions (can be configured using FredCo Software).

ECG display option :

33.Connect an ECG simulator to the unit and check if you can see ECG waveform on the screen.

INSPECTION OF LEAKAGE CURRENTS (according to the international standard : IEC 60601-1 and 60601-2-4) :

34.Connect a leakage currents test device to the inputs/outputs of the device, note the kind, the serial number and the deadline
calibration of the test device. The values must imperatively be located between the tolerances
Has not to be performed during the 3 yearly maintenance, if the Easy has not been opened

Has to be performed during the 6 yearly maintenance after the obliged replacement of the memory back up battery
Has to be performed after a repair of the Easy (as soon as the Fred Easy has been opened)

ELECTRICAL CLASS UNIT : Internally powered

Admissible maximum values (A)
PATIENT LEAKAGE CURRENT
Defibrillator IEC 60601-2-4 (BF)
Normal condition

100

Normal condition, reversed mains

100
Admissible maximum values (A)

PATIENT AUXILIARY CURRENT

Defibrillator IEC 60601-2-4 (BF)
Normal condition

100

Normal condition, reversed mains

100
Admissible maximum values (A)

MAINS ON APPLIED PARTS

Defibrillator IEC 60601-2-4 (BF)
Single fault condition

5000

Single fault condition, reversed mains

5000