Gebrauchsanweisung

Instructions for use

Mode dOemploi
lnstruzioni per I'uso
Manual de instrucciones
Instru~Besde uso

-
--
METRAX
- - 19621 / 05.02 GmbH
Gebrauctisanweisung Seite

Instructions for use

Mode d'emploi Page 48 - 71

lnstruzionl per I'uso pagina 72 - 95

Manual de instrucciones pagina

lnstrucoes de uso pagina 1 2 0 - 143

nstructions for use Defi-N / Defi-B
PRIMEDIC~~

Table of contents Page

1. Safety instructions

2. Device Specification
TIICPRIMEDIC'" Defi-N MI00
The PRIMEDIC' Defi-B M I 10

3. Preliminary measures
3 1 Loadlng the rechargeable batteries (only Defi-B)

4. Operation of the defibrillator

4 1 Switching the deflbr~llatoron and off / self-test
4.2 Energy selection
4.3 Energy charglng
4 . 4 Posltionlng of paddles
4.5 Discharging of energy
4.6 Paediatric paddles

5. Maintenance and care

5 1 Maintenance of the accumulator (only for Defi-B)

6. Waste treatment

7. Technical data, accessories, symbols

7 . 1 Technlcal data PRIMEDIC'" Defi-N
7 . 2 Technlcal data PRIMEDIC'" Defi-B
7 3 Symbols

8. Conditions of Guarantee

9. Appendix
A1 General ~nstruct~onsand rules for the handllng of deflbr~llators
A2 Voltage - tlme graphs
A 3 Safety control

PRIMEDICT"is registered trademark of METRAX GmbH, Rottwell. Germany

PRIMEDIC Defi-N / Defi-B Instructions for use

1. Safety instructions

The follow~nghas to be cons~deredIn order to ensure safe and perfect function of the PRIMEDIC"
Def~br~llators
and to a v o d r~skto human be~ngsand other mater~alproperty

1. Any use of the PRIMEDIC'" Def~br~llators

requires the knowledge and strict compl~anceof these
nstructions for use

2 The PRIMEDICTMDef~br~llators are des~gnedand su~tableexclus~velyfor the appl~cat~onsset out

or descrbed In t h ~ smanual U s ~ n gthe devlce for purposes any other than those ment~onedIn
t h ~ smanual may constltute a r ~ s kand has to be o m ~ t t e d

3. Operation of the PRIMEDIC'" Def~br~llators, as well as bas~callyall other def~br~llators,

in areas
subject to explos~onhazards I S not allowed.

4 The PRIMEDIC'" Defibrillators may only be used by tra~nedand authorised personnel Reading
the instruc-tlons for use does not replace any tra~ning.

5. Any repair work, modificat~ons.a d d ~ t ~ o nand

s ~nstallat~ons
of the PRIMEDIC'" Defibrillators may
only be carried out by personnel authorised and trained by METRAX. The parts of the
PRIMEDICTM Def~br~llators
may not be repaired by the user.

6. The dev~cemay only be used w ~ t haccessories, wearlng parts and disposable parts the secure
use of which IS proofed by an lnspectlon off~ceauthorlsed to tests of devices ready-to-use.
Otherw~sea safe and reliable funci.ion of PRIMEDIC'" Defibr~llatorsIS not guaranteed. The
o r ~ g ~ nPRIMEDIC'~
al accessories and wearing parts comply with t h ~ s
cond~tion.

7. Before uslng the dev~cethe user has to check that the device IS in a safe and relable state. If e.g.
the defibrillator cable is damaged the def~brillatormay not be used.

8. The instruct~onsand rules set out in append~xA 1 have to be conipl~edw ~ t hwhen uslng the
PRIMEDIC'" Defibrillators.

9 The unit must be under operating c o n d ~ t ~ o nbefore

s uslng.

10 The PRIMEDIC'" Defi-N is not suitable for use outdoors

11 Do not use the PRIMEDIC'~Def~br~llators near devices (e g measuring dev~ces)sens~bleto

magnetic flelds or d ~ s t u r b ~ nsources,
g w h ~ c hcould Interfere w ~ t hthe funct~onsof PRIMEDIC'"
Def~br~llatorsKeep suffic~entd~stance

12 Do not charge more than 1 5 times at maxlmum energy The number of dscharges should not
exceed 3 per minute Afterward, allow the u n t to cool down for an extended period of time

y nat~onalregulations for the use of medical devices are appl~cable

A d d ~ t ~ o n athe

Manufacturer. METRAX GmbH

Rhe1nwadstral3e2 2
D - 7 8 6 2 8 Rottweil
Phone: +49 ( 0 ) 7 4 1 / 257-0
Fax: +49(0)741/257-235
Instructions for use Defi-N / Defi B
PRIMEDICTM

2. Device Specification

The PRIMEDIC'~Defi-N MI00

Fig.: 1 General view of the PRIMEDIC'" Defi-N

Carry~nghandle
Release button
Paddle r ~ g h(APEX)
t
Paddle cable
Def~brillatorunlt with operating elements
M a ~ n splug
Paddle cable
Paddle left
Release button
 Defi-N / Defi-B
PRIMEDIC~" Instruci:ions for use

PRIMEDIC
Defi-N

Fig.: 2 Defibrillator unit with operating elements and displays

20 Power switch To swtc11 the device on or off

21 LED To d s p l a y the selected energy step
22 Energy key To select the defibrillation energy
23 LED To s ~ g n athe
l charging of the defibrila-tion energy
24 Load key To load energy for defibrllaton
25 OKLED To signal that selected energy is charged and a v a l a b e for the shock
26 A t t e n t o n LED To signal malfunct~onof tlie de.iibrlation unlt
Instruci:ions for use PRIMEDIC'"Defi-N / Defi B
--

The PRIMEDIC" Defi-B MI 10

8 9 1 2 3

Fig.: 1 General view of the PRIMEDICTU

Defi-B

Carry~nghandle
Release button
Paddle right (APEX)
Paddle cable
Defibr~llatorunit w ~ t hoperating elements
M a n s plug
Paddle cable
Paddle left
Release button
Instructions for use Defi-N / Defi B
PRIMEDIC~~

3. Preliminary measures
The appliance can be kept on stando, zth In a hor: +a1
and an upright posltlon
Defl-N Insert mains plug n socket in the v c - , 3f ergomete-
The mains cable has a length of 3 m thereo, :ermlttlng
correspond~ngoperating radus ernerglencles
Defi-B W ~ t hthe Integrated rechargeable accumula*- ou are
Independent of a power source

3.1 Loading the rechargeable batteries

(only Defi-6)
To load the Integral rechargeable batter~es connec: the
appl~anceto the electr~caloutlet w ~ t ht h e power cord ( 6 ) Tile
s w ~ t c h(20) should be In the ,OFF Poslton The green LEE
( 2 8 ) next to the accumulator charge symbol ~ r d c a t e s
LED flash~ng or steady The rechargeable batter~es are
charg~ngor the appl~anceis In the floatlng operatlon niode

LED off The rechargeable batter~es are no longer b e ~ n g

charged, because a l i m ~ tvalue has been exceeded ( e g
temperature or end-of-charge voltage) As soon as the l ~ m ~ t
value exceeded status I S cleared the LED flashes agaln

Caution:
The malns connecilon I S only for charg~ng batteries
D e f ~ b r ~ l l a t ~cannot
on be tr~ggered~fthe appl~anceto a power
source when the batter~esare empty The charge time I S appr
3.5 hours To guarantee full readiness for operatlon. the
appl~ancemust be connected to the malns at regular ~ntervals
(e g olice a week) Should the unlt not be used, Continuos
mains c o n n e c t ~ o ~isi also poss~ble,t h ~ sw ~ not
l damage the
batter~es

Note:
In case that the def~brillatorsare operated from a i:lmer (e g
n ~ g hd~sconnect~on)
t it may not be uninterruptedly connected
to this socket. Otherwise tlie reconnecting of the power
supply w ~ l lcause a renewed charg~ngprocedure. This can
cause damage to the battery due to over charg~ng.
PRIMEDIC~"Defi-N / Defi-B Instructions for use

4. Operation of the defibrillator

4.1 Switching the defibrillator on and o f f /
self-test
Switch on the PRIMEDICT"defibr~latorwith ti-e power switct-
(20).
W h e n starting an internal self-test will be execci-2: - 3 check
important functions and signal devices The SF---?st is
finished in approx 2 0 seconds ( D e f i - B ) resp 1 1 -e 2-ds
( D e f i - N ) and the appliance signals read~nessfor o p e P c -:I
through a b r ~ e fbuzzing tone The LED ( 2 1 ) correspondin; -:
energy level 2 0 joules flashes

Caution:
During the internal self-test, a defective c it may discharge
high tension via the paddle electrodes. Please always pay
attention that the paddles are fixed in the acco;::-2 supports
during tkis self-test, in order t o avoid contact w i t h t'-e o a t e n t
or the user!
If, during self-testing, an error or internal ~ a f u n c t i o nhas beep-
discovered, then this will be indicated b y the .eel warriing LED
( 2 6 ) and cyclical beeping sound.
Now, by pressing the load key ( 2 4 ) , the systerr c a n be
instructed t o correct the error. The LED'S of the power sics
( 2 1 ) run cyclically as ,,running light". After pressing the oao
key ( 2 4 ) again, and assuming the correction of malfunction
was successful, the De.l.ibrillator is again ready for use, If the
malfunction or error m o d e is resumed, then Service should be
informed. There is a defect.
Diminished Readiness to operate
The system-test determines that a least 2 0 shocks w i t h 3 6 0
joules are stored. This is indicated by a red steady-burning
accumulator-status LED ( 2 7 ) . (Only DeTi-B)

Conditionally ready to operate

If the system-test discovers that there are 1 0 or less shocks
w i t h 3 6 0 joules stored in the accumulator, then the readiness
for operation will be indicated by the blinking of the red
light ( 2 6 ) at the symbol accumulator status. (only D e f i - B )

Rechargeable batteries are empty

It the accumulators are already upon switching t h e device
upon the this is indicated by the blinking of the red light
( 2 6 ) at the symbol for accumulator status as well as b ,
pulsating beeping sounds The device is not operab e
Please connect the unit t o the mains as soon as p o s s b e in
order t o guarantee the readiness for use (only D e f i - B \
nstructions for use Defi-N / Defi B
PRIMEDIC~~

4.2 Energy selection

Press one of keys ( 2 2 ) to select the energ!: LED ( 2 1 ) c,-+ed
directly above the key pressed l~ghtsup to acknowledge - - e
energy settlng

Note:
The energy step required for tlie d e f ~ b r ~ l a t ~depends
on on the
patient, ~ t sbody h e ~ g h tand w e ~ g h tand ~ t sc o n d t c q For
information please refer to append~xA 1
Advice:
If a wrong energy step was chosen, you may change ~t by
presslng the right button w ~ t hthe new energy step However,
it will only work if the load key has not been act~vatedIn the
meanwh~le
If the load key was already pressed, a correct~on is only
poss~bleby s w ~ t c h ~ nthe
g unlt off and turning ~ton agaln, Walt
~ u n t ~the
l 1 5 seconds have exceeded and the energy was
discharged internally or by destroy~ngthe energy (pressing
both release buttons s~multaneouslyto d~schargethe energy
In the u n ~ t )

4.3 Energy charging

The selected energy can be charged by presslng the load key
(24) and thus made ava~lablefor the shock.
LED ( 2 3 ) flashing indicates the charging procedure The
charging time depends on the selected energy step. W ~ t hfull
accumulators, a charging tlme of approx. 7 seconds for Defi-
B resp. 9 seconds for Defl-N is requ~red to attain the
maximum energy of 3 6 0 joules

After the charging the energy will be available for 1 5 seconds

which is s~gnalledby a permanent s~gnaland the l~ghtingup
of the OK signal ( 2 5 ) . If there IS no d e f ~ b r ~ l l a t ~during
on th~s
tinie, an Internal safety d~schargewill be executed Afterwards
the def~brillatoris ~ m m e d ~ a t eready
ly to use.

Should an error occur d u r ~ n genergy charging, an intermittent

warning s~gnaland the Attention LED ( 2 6 ) w ~ l be
l on

Attention:
If the Attent~on LED ( 2 6 ) l~ghts up the funct~on of the
defibr~llatorcan be tested by sw~tch~ng-off
and then on again
with the help of a self-test. When the signal goes out, the
def~br~llatorI S ready-to-use.

Attention:
If the Attention LED ( 2 6 ) is st111on after switch~ngoff and on
agaln, the malfunction must be eliminated immed~ately.
 Instructions for use

4.4 Positioning of paddles

Grasp the paddles ( 3 and 8) on the grlps and remove them
STERNUM-Paddle from thelr support by pulling to the rlght resp to the lei' The

;. I I
-
:.
.
\
\
paddles must be positioned along the cardlac axls The APEX-
paddle has to be posltloned In the left chest area, on
axlllary lhne above the apex of the heart The second paddle
has to be posltloned In the right chest area below the
clavcle
e

P
1 ;;//'-', ,
/A\
Attention:
To avold skln burns. ~t 1s extremely Important to apply a
suff~clentquantlty of gel to the electrode surface
" \APEX-Paddle
Attention:
i , Both paddles have to be pressed on the thorax by apply~nga
pressure of approx 10 kg In order to ensure safe energy
transmlsslon and to avold damag~ng the skln under the
paddles
Attention:
Please insure that there is no contact or conducting gel
between the paddles

4.5 Discharging of energy

Press release buttons ( 2 ) and ( 9 ) at the paddles
simultaneously to discharge the energy The energy w I I be
discharged lmmedlately after simultaneous depression of
buttons.
After defibrillation, the LED ( 2 1 ) corresponding to the energy
level prev~ouslyselected flashes. This allows you to check
whether defibrillation has actually taken place.
Attention:
Before and durlng the discharging of energy all persons
attending to the resuscitation have to step back and any
contact wlth palients or conducting parts (e. g. stretcher) has
to be avoided. Remove all connected devlces without
deflbrlllation protection from the patient before energy 1s
discharged.
Attention:
Avold a discharging of contacting Paddles (short-circuit 1)

4.6 Paediatric paddles

Electrodes with smaller electrode surface have to be used for
the defibrillation of children. The paediatrlc paddles are
Integrated In the paddles for adults. Remove the large
electrodes from both paddles by turning counterclockw~se.
Attach the paddles for adults to the paediatric electrodes by
turnlng clockwise.

Note: Clean the paedlatric paddles after use before attachng

the paddles for adults.
Attention:
Attach the paddles for adults f~rnilyto ensure safe contact of
the paddles for adults.
Instructions for use PRIMEDIC'~Defi-N / Defi B

5. Maintenance and care

Ensure that the appl~ancehas been s w t ~-d off and p l ~ _
out
Normal domest~cclean~ngagents can be usec - +end~ng
the
def~br~llator
Always use a clean cotti
Use a commerc~al d~s~nfectant( e g Gigasep- -F) for
disinfect~onof the paddle electrodes
Attention:
Do not use soak~ngwet clothes for cleaning Do not pour a
l ~ q u ~ dover
s tlie dev~ceand do not plunge ~tInto vvater
Regardless of the use of the dev~ce we recommeqd vlsual
lnspectlons / malntenance of the PRlMEDlC Defi-B and
the accessory parts to be carr~edout by the uaer
Pay attention to the following:
1 Check whether the parts of the casng are damage0
2 Check whether the ~nsulat~on
of the paddle cable 1s
damaged
3 Remove remalnlng gel and lmpurltles f r o r ti-e paddle
electrodes In order to ensure safe contact herween
cli~ldren'spaddles and paddles for adults and to p r e \ e i t
spark~ngvoltage

Only valid for Defi-B:

In order to guarantee a perfect f u n c t o n n g of the unlt, the u n t
bust be equipped with a accumulator In working order. The
unit must enable 1 5 shocks w ~ t l ai full accumulator - should
this not be the case, METRAX recommends to get the
accumulator changed through the service department
The user may check the accumulator capaclty by charging the
unlt completely and by d~schargingthe requested 15 shocks
(please see polnt 6 of the techn~calsafety controls)

Attention:
Damaged parts of the casing and isolations have to be
repalred immediately.

Advice:
Please find enclosed (annexe A 3 ) supplen~entaryinformat~on
concerning the regular Intervals of the techn~cal securlty
controls according to the g u ~ d e n e ,,Med~z~nprodukte-
Betreiberverordnung" (MPBetreibV)
 Instructions for use

5.1 Maintenance of the accumulator 1 crlly

for Defi-B)
In order to reach a long durablllty ot ' t 2 accumulator -
necessary to use the greater part of accu-- lator capaclt, .
you use only part of the capacity. the so-calle, -1eniory effec-
will occur Thls may cause a defect of the accun7, ator
Please consider the following advices in order t o
prevent this procedure:
Charge accumulator / unit ( r n ~ n ~ r n u n4i hours 2: *lie
public supply).
Pull out mains plug.
Use the unit until the red Accumulator-status-LED ( 2 7 ) will
lighten (reserve of 1 5 shots w ~ t h3 6 0 J).
Put the unit then again to the public supply and recharge
~t(the unit must be turned out).
After charging please disconnect the unit from public
supply then.

If you charge the accumulator prematurely (that means when

the Accumulator-status-LED ( 2 9 ) is st111llghten~nggreen) you
will risk to damage the acc~~mulator on a long-term basis.

6. Waste treatment
At the end of its useful life, the unit must be recycled in
accordance with the relevant local regulations. In case of
doubt, please request details from the local recycling
company.
nstructions for use Defi-N / Defi B
PRIMEDIC~~

7. Technical data, accessories, symbols

7.1 Technical data PRIMEDIC'~Defi-N

Defibrillation:
Operatng mode. asynchronous, external d e f ~ b r ~ l l a t ~ o n
Energy steps. 2 0 , 50, 1 0 0 , 1 6 0 , 2 5 0 , 3 6 0 joule ( 5 0 Q)
Charging tlme approx. 9 s ( 3 6 0 Joule) with 2 3 0 V / 5 0 Hz
Paddle: Paddle for children Integrated

Safety Class~f~cat~on. Protect~ontype II, Type BF, Medlcal devlce class 2b

Regulatory affairs:

Other data:
Nominal m a n clrcult. see ratlng plate
Operatng condltlons 0 4 0 " C , 3 0 9 5 % re1 humldlty but wlthoc~tcondensation
7 0 0 hPa 1 0 6 0 hPa
Storage environment. - 2 0 ... 7 0 "C, 2 0 ... 9 5 % re1 humid~ty,but wlihout condensaton
5 0 0 hPa ... 1 0 6 0 hPa

Subject to alterations

Delivery specification:
Part no.
90426

consists of:
1 Conductve gel, 6 0 g
1 Medlcal device protocol
1 Instructions for use
1 Briefing protocol

Accessories
Part no.
Bag w ~ t htwo transparent storage compartments 14467
Conduct~vegel, 6 0 g 13026
PRIMEDIC'~Defi-N / Defi-B Instructions f o r use

7.2 Technical data PRIMEDIC'~Defi-B

Defibrillation:
Op- ' ng mode asynchronous external defibrilat~on
E --gy steps 2 0 5 0 1 0 0 1 6 0 2 5 0 3 6 0 joule ( 5 0 R)
C i a r g ~ n gtime approx 7 s ( 3 6 0 Joule)
Paddle Paddle for cliidren integrated

Safet, Ciassification Protection type I Type BF, Medical device class 2 b

Regulatory affairs.

Other data:
Power supply: by accumulator 1 4 . 4 V / 1,5 Ah
Nominal voltage. see rating plate
Charging time 3,5 hours ( 1 0 0 %)
A c c u ~ ~ ! a tcapacity:
or 3 5 shocks + 1 0 In reserve ( 3 6 0 Joule)
Operating conditions. 0 4 0 OC, 3 0 9 5 % re1 humidity but without condensation
7 0 0 hPa 1 0 6 0 hPa
Storage environment: -20 7 0 "C 2 0 9 5 % re1 hum~dlty,but wlthout condensation
5 0 0 hPa 1 0 6 0 hPa
Dimensions. 4 0 x 4 8 1
~2cm(wxdxh)
Welght: 9 kg

Subject to alterations.

Delivery specification
Part no.
90427
consists of
1 Conduciive gel 6 0 g
1 Medical device protocol
1 Instructions for use
1 Briefing protocol

Accessories
Part no.
Bag w ~ t htwo transparent storage compartments 14467
Conductive gel, 6 0 g 13026
instructions for use Defi-N / Defi B
PRIMEDICTM

7.3 Symbols

The followng symbols are used on the device:

Rating plate:

Protection type II

Drlp-proof (Defi-N)
IPX 1

I PX4

Comply with lnstructlons for use1

Degree of protection BF

Paddle / Casing:

f Hazardous electrlc voltage

(hlgh voltage)

Danger

FIXpaddles wlthin fitting before swltchlng on

PRIMEDIC-MDefi-N / Defi-B Instructions for use

Operating elements:

Defi-N: Connect mains cable, S w t c h unit on

only Defi-B:Accumulator charge synibol

only Defi-B:Accumulator status symbol

Apply conductive gel to paddle electrodes

Select energy step according to body weight

20 / 5 0 Joule 1 0 - 3 0 kg body w e ~ g h t

1 0 0 / 1 6 0 Joule 3 0 - 5 0 kg body weight

2 5 0 / 3 6 0 Joule as of 5 0 kg body weight

Charge energy

Place addles

Discharge energy
Give shock

System error1
Def~br~llation
impossible!
Instructions for use PRIMEDIC-h'Defi-N / Defi B

8. Conditions of Guarantee

the manufacturer, METRAX grants a guarantee on this dev~cefor 2 years startng with the - -f
purchase D - ~ r n gthis p e r ~ o dMETRAX w ~ l elim~nate
l any defects in the device r e b J t n g from ma -
faults or rranufacturing faults free-of-charge Elim~nationof defects is made by METRAX ether by repa
or by replacement Any repair carried out during the guarantee per~odshall not extep the or~ginal
guarantee per~od

T - e r ~ g h to
t c l a ~ munder guarantee and damage claims prov~dedby law do not apply in case o* z i l y
mmaterial Impairment of usefulness natural wear or damages, produced after l i a b ~ l t ytransfer to tf-e
buyer, as a result of wrong or negligent use, excessive stress or caused by extreme external influences
not covered by the terms of agreement The same applies if the buyer or third parties perform
mod~f~cations or repair work in an unprofessional manner

Further contractual and non-contractual claims against METRAX are excluded unless such claims are
based on intent or on severe negligence or on compelling liabil~tyregulat~onsprovided by law.

Claims for damages by the buyer against the seller (trader) remain unaffected by this guarantee

In case of claims under guarantee, you are asked to send the device ~ncludinga buyer's cert~ficate(e g
a bill) statlng your name and address, to your dealer or to METRAX

The METRAX-customer service will be glad to assist you even after the guarantee period has expired !
PRIMEDIC.~Defi-N / Defi-B Instructions for use

9. Appendix

A1 General instructions and rules for the handling of defibrillators

What is a defibrillator ?
C .Ing d e f ~ b r ~ l l a t ~current
on I S del~vered to the heart muscle The contractlon caused and the
aepolar~zatonof the heart muscle e l ~ m ~ n adangerous
te cardlac ~rregular~ty

Cardiac r-egular~tymeans uncoordinated electr~cand mechan~calactivities of the heart muscle

Dysrhythmia possible measures

partly uncoord~natedactlvitles of the heart synchronized defibrlllatlon

nluscle (e. g. atrial fibrllat~on) (cardloversion)

completely uncoordinated actlvltles of the heart Unsynchron~sedd e f ~ b r ~ l l a t ~ o n

muscle (ventr~cularflutter)

The a m table shows two general groups of cardlac Irregularity and the poss~blecounter-measures.
PRIMEDIC'~defibrillators Defi-N and Defi-B are des~gnedfor assyncl-~roniousdef~brillat~on,
therefore
synchronious cardloversons are not poss~ble.

The procedure of the two cardioversions are different and described in the following:

1. Unsynchronized defibrillation:
W ~ t hthis procedure energy I S released ~ m m e d ~ a t eas
l y soon as the keys for "shock release" are pressed
T h ~ sprocedure requlres the clear and d e f ~ n ~ establishment
te of the d ~ a g n o s ~"ventr~cular
s flutter or pulse
missing".
Asynchronous supply of energy to the cardiac rhythm by the def~br~llator can cause damages to the
heart. If the energy 1s suppl~edto the heart muscle d u r ~ n gthe ventr~cularrefractory period (approx. f~rst
half of the T-wave) the heart I S susceptible to ventr~cularfibr~llat~on

2. Synchronized defibrillation (not with Defi-N and Defi-B):

For the applica-tion of this procedure it is essen-tial that the patient has got a d~scern~ble
heart rhythm. A
clear ORS complex In the ECG 1s requ~redfor the synchronous shock release. Controlled by the
synchronous mechan~smof the ECG unit, the shock is released a few m~lliseconds(about 10-60ms)
after detect~onof the R-peak.
The ECG unit marks the detected QRS complex w ~ t ha "SYNC" marker serving as a ~ dfor the doctor in
charge
The best "care" of the doctor releas~ngthe shock I S ~ndspensabled u r ~ n gt h ~ sprocedure He has to
watch the ECG s~gnalon the monltor cont~nuouslyand ensure that every QRS cornplex 1s detected and
no artefacts or pacemaker pulses are synchron~zed
Instructions for use PRIMEDIC'" Defi-N / Defi B

Procedure for defibrillation (unsynchronized):

The steps for d e f ~ b r ~ l a t ~descr~bed
on in the follow~ngapply for the * - a i d l ~ n gof the d e 2r only The
G - [tie m e c l i a n c a card~opulomaryor pharmacolog~calresuscltat~onis -ot descr~bed
-
, he p r o c e d ~r e of the unsynchron~zedcard~overs~on must only be appliea -case of venti~c r ~ l l a i ~ oIn e
,
P-, QRS- or T peaks msslng In the ECG of the patlent
1. Switch on defibrillator.
2. Apply electrode gel to paddle electrodes.
Apply sufficent electrode gel on the paddle electrodes to h m ~ tthe contac: ..?jstance so t:-.:- - - 9
energy can be released completely to the patient. lnsufflcent contact gel ma, r:l.lse that the :.
under the electrodes gets burnt.
Do not spread the electrode gel on the handles of the paddles. otherwise energy 0 - 3 .'lash over to
the doctor in charge of the defibrillat~on.
3. Select energy.
The energy to be released depends on the patlent's body helght and wegi-t The follow~ng of
thumb applles 2 - 3 joule per kg body w e ~ g h tThe most sultable energy is based on experience
depends on the emergency sltuatlon
4. Positioning of the paddles.
S t c k the paddles f ~ r m l yto the bare chest of the patlent by a p p y n g a pressure of apprcx 10 kg to
ensure perfect energy transfer Apply~ngnot enough pressure may cause that the skin ,-3er the
electrodes gets burnt Apply~ng correct pressure should be tra~nedon devices provided - c r that
purpose
The posltlon of the paddles decldes on the success of the resuscltatlon The flow of current betwee-
the paddles through the chest has to flow through a large part of the tissue of the heart muscle The
chance to e l ~ m ~ n a the
t e ventr~cularf ~ b r l l l a i ~ oonly
n exlsts when the "crlt~calmass" of about 8 0 % of the
heart I S perfused suff~c~ently
In case of Incorrect paddle poslt~onmost of the current mlsses the heart and 1s thus Ineffect ve
Position of the first paddle (Sternum): - r ~ g h chest
t area
- r ~ g h close
t to sternum
- below the clavcle
Position of the other paddle (Apex): - left lower chest area
- above apex of the heart
- midax~llarylhne
Make sure that no electrode gel has been spread between the paddles on the patlent's chest
Otherw~sethe current flows on the surface between the paddles Do not spread the electrode gel on
the handles of the paddles, otherw~seenergy may flash over to the doctor In charge
5. Energy charging
After charglng the energy remalns ava~lablefor a l ~ r i i ~ t etime,
d i e 15 seconds with the PRIMEDIC'~
defibrillators. If no shock is released d u r ~ n gt h ~ stime the energy IS d~schargedInternally for safety
reasons and has to be recharged afterwards.
6. Protection against electric shock.
Before defibr~llat~ng the doctor releasing the shock has to ask all persons attend~ng to the
resuscltatlon clearly and unm~stakablyto step back from the treatment locat~onand to touch neither
the patlent nor the bed nor the connected devlces. Remove any dev~cesw ~ t h o u t deilbrillatlon
protection from the patlent before releasing the shock. Otherw~seenergy may flash over to persons In
unfavourable sltuat~ons.
7. Discharge energy (shock).
Discharge the defibr~llatorby presslng both release buttons on the paddles simultaneously
8. Check the result.
Check the c o n d ~ t ~ oofn the patlent and the ECG nionltor after d e f ~ b r ~ l l a t ~Depend~ng
on on the result of
the d e f b r ~ l l a t ~ ofurther
n def~br~llatlons In qulck succession m ~ g h be
t necessary (repeat steps 3-8) The
emergency p h y s ~ c ~ amay n ask for accompanying manual or pharmacolog~calmeasures
9. Keep the defibrillator ready for use.
Clean the paddles, cable and electrodes at the end of the resuscltat~onto ensure ava~labil~ty of the
def~br~llator for the next a p p l ~ c a t ~ o n
Funci~onald~sordersor faults have to be checked or f requ~redrectlf~edlmmedlately by an authorized
servce t e c h n ~ c ~ a n
 Defi-N / Defi-B
PRIMEDIC~~ Instructions for use

A2 Voltage -time graphs

pleas^ r n d In the follow~ngthe graph shapes of the deflbrlllatlon pulses depending on the tormlnal
res stance

1. Graph shape with 25 R

Graph shape with 50 R

U = 2.940 V 2 ms / div
Instrucl:ions for use Defi-N / Defi B
PRIMEDIC~~

3. Graph shape with 100 R

4. Graph shape with 125 R

U = 2.800V 2 ms / div
 Instructions fcr use

A3 Safety control
Accor: 3 to M e d i z i r o r ~ a ~ k t Betre~berverordnung
e (MPBetreibV) 9 6 (safety controls, isers of
c l e f - * drors are o b l ~ e : : to have the devices controlled A c c o r d ~ n gt o MPBe:-ebV g 6 METP-X has
c--:;ribed contro s r 1 2 m o n t h cycles

~ l s be carried out only b y persons qualified by their tralnlng, th,e * i n o w l e d g e i -:

-ne safety ~ c - - ~ must
experience 221ned in practice t o execute controls professionally and not receiving any I-structlons fc,
the con--:Is They also must d ~ s p o s eof the appropriate measure- and test instruments
If +-E. safety control reveals any defect that represents a hazard for patients employees or ti;-c: oartes,
tl-e responsible a u t h o r ~ t yhas t o be informed ~ m m e d ~ a t eb y the user a c c o r d ~ n gto MPBetreibV 5 3

In accordance with MPBetre~bV3 7 the f o l l o w ~ n gdata has t o be entered In the medical d e v ~ c epro;:cc
accompanying the d e v ~ c e
T i l e w h e n the work was carried out
Name of the person or company w h o / w h ~ c h carr~edout the work and
the work carried out
METRAX c a r be held responsible for the contents of the operating manual only This especially apol~es
t o n e w seTtngs,commissioning and modificat~onst o the device
In the -otatonal control tlie f o o w ~ n gwork and checks have t o be undertaken by a service t e c h n c a r
1. Check whether the device shows external damages
Casing deformed?
Paddle cable damaged?
Mains p l i ~ gdamaged
Paddle damaged?
Paddle for adults available and attached?
R a t ~ n gplate o n the back of the d e v ~ c elegible?

2. Check whether operating elements are damaged

Release buttons damaged?
M a n s switch dust-cover damaged?
M a n s switch and rocker are in order?
Membrane keyboard legible?
Menibrane keyboard damaged?

3.1 Display Elements Defi-N

Check the LEDs in the membrane keyboard:
The LED allocated t o the selected energy step lights u p (check all energy steps once).
After pressing the load key ( 2 4 ) , the according LED ( 2 3 ) must ~ l i u m n a t e .
Check the acoustic warning s~gnals.

3.2 Display Elements Defi-B

One of the LED'S on the accumulator status display must light up w h e n unlt 1s turned on.
Check the LED'S in the membrane keyboard for proper function:
The LED allocated t o the selected energy step lights u p (check all energy steps once)
After pressing the load key ( 2 4 ) , the according LED ( 2 3 ) must illuminate.
Check the acoustic warning signals.
4.1 Measure the charging time Defi-N
Switch off device - a n d s w ~ t c hit on again.
Press the key 3 6 0 Joule ( 2 2 ) .
Press the load key ( 2 4 ) w h ~ concurren-ty
e switching on the stop-watch.
At 2 3 0 V / 5 0 Hz supply voltage the c h a r g ~ n gtime should not exceed 9 seconds.
A t 2 0 0 V / 5 0 Hz supply voltage the charging tlme should not exceed 1 4 seconds.
4.2 Measure the charging time Defi-B
Switch off device - and switch it o n again.
Press the key 3 6 0 Joule ( 2 2 ) .
Press the load key ( 2 4 ) while concurrently switching on the stop-watch.
W i t h the accumulator fully charged, the charging time may not exceed 7 seconds
After 1 5 defibrllatlons w i t h 3 6 0 joules, loading takes only slightly longer
nstructions for use PRIMEDIC'~Defi-N / Defi B

5. Measuring the power output

When checking the defibr~llai~on energy at a 5 0 Ohm load the follow~ng dev~at~ons a'o
perm~ssbe
2 0 Joule f 4 Joule
50 - 3 6 0 Joule f 15 %
All energy levels between 20 joules and 3 6 0 joules are measured
Dur~ngthe measuring process, make sure that the d~schargesequence of 3 t n i e s per minute s
not exceeded Faster sequences w ~ l l not destroy the dev~ce, but ~t I S poss ble that the
thermostatc s w ~ t c hw ~ loperate
l In the h~gh-voltagetransformer

6. Replacing the batteries (only Defi-B)

If 1 5 d~schargesare no longer possible in the text mention under Item 4 then the batteries
should be replaced. (It is required, however, that accumulator was fully charged d u r ~ n gthe test).

7. Measuring of the patient's lead current according to EN 60601-1.

PRIMEDIC Defi-B

BATTERY P-140SCS 4x3

14,4V / 1400mA
J1

RED 1
+
BT1 BT9
P-140scs P-140scs
RT1 J3
BT5 NTC PHILIPS 640 100k
P-140scs BLUE 1
BT2 BT10
P-140scs P-140scs
CON1
BT6 J4

BT3
P-140scs
BT11
t t BLUE 1
P-140scs P-140scs
RT2
BT7 NTC PHILIPS 640 100k CON1
P-140scs
BT4 BT12
P-140scs P-140scs
J2
BT8
P-140scs BLACK 1
-