Primedic Defi-B [PDF]

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Gebrauchsanweisung Instructions for use Mode dOemploi lnstruzioni per I'uso Manual de instrucciones Instru~Besde uso



--



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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



PRIMEDIC~~ Defi-N / Defi-B



Table of contents 1.



2.



Safety instructions Device Specification PRIMEDIC'" Defi-N MI00 The PRIMEDIC' Defi-B M I 10



TIIC



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 and rules for the handllng of deflbr~llators A1 General ~nstruct~ons A2 Voltage - tlme graphs A 3 Safety control



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



Page



PRIMEDIC Defi-N / Defi-B



1.



Instructions for use



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~ons set 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 g w h ~ c hcould Interfere w ~ t hthe funct~onsof PRIMEDIC'" magnetic flelds or d ~ s t u r b ~ nsources, Def~br~llators Keep 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



A d d ~ t ~ o n athe y nat~onalregulations for the use of medical devices are appl~cable



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



2.



Device Specification



The PRIMEDIC'~Defi-N MI00



Fig.: 1



General view of the PRIMEDIC'" Defi-N



Carry~nghandle Release button t Paddle r ~ g h(APEX) Paddle cable Def~brillatorunlt with operating elements M a ~ n splug Paddle cable Paddle left Release button



PRIMEDICTM Defi-N / Defi B



PRIMEDIC~" Defi-N / Defi-B



Instruci:ions for use



PRIMEDIC Defi-N



Fig.: 2 20 21 22 23 24 25 26



Defibrillator unit with operating elements and displays Power switch LED Energy key LED Load key OKLED A t t e n t o n LED



To To To To To To To



swtc11 the device on or off d s p l a y the selected energy step select the defibrillation energy s ~ g n athe l charging of the defibrila-tion energy load energy for defibrllaton signal that selected energy is charged and a v a l a b e for the shock signal malfunct~onof tlie de.iibrlation unlt



PRIMEDIC'"Defi-N / Defi B



Instruci:ions for use



-



The PRIMEDIC" Defi-B MI 10



8



9



1



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



2



3



PRIMEDIC~~ Defi-N / Defi B



Instructions for use



3.



Preliminary measures



+a1 The appliance can be kept on stando, zth In a hor: and an upright posltlon Defl-N Insert mains plug n socket in the v c - , 3f ergometeThe 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 beepdiscovered, 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 \



PRIMEDIC~~ Defi-N / Defi B



nstructions for use



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 DefiB 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~llator I 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 STERNUM-Paddle



;. I



I



: . . \



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



i



Grasp the paddles ( 3 and 8) on the grlps and remove them from thelr support by pulling to the rlght resp to the lei' The paddles must be positioned along the cardlac axls The APEXpaddle has to be posltloned In the left chest area, on e axlllary lhne above the apex of the heart The second paddle has to be posltloned In the right chest area below the clavcle



,



Attention: 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.



PRIMEDIC'~Defi-N / Defi B



Instructions for use



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 def~br~llator Always use a clean cotti Use a commerc~al d~s~nfectant( e disinfect~onof the paddle electrodes



g



-



+end~ng the



Gigasep- -F)



for



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~nprodukteBetreiberverordnung" (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 effecwill 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 public supply).



2:



*lie



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.



PRIMEDIC~~ Defi-N / Defi B



nstructions for use



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



Paddle:



Paddle for children Integrated



Safety Class~f~cat~on.



Protect~ontype II, Type BF, Medlcal devlce class 2b



/ 5 0 Hz



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 1 1 1



Conductve gel, 6 0 g Medlcal device protocol Instructions for use Briefing protocol



Accessories Part no. Bag w ~ t htwo transparent storage compartments Conduct~vegel, 6 0 g



14467 13026



Instructions



PRIMEDIC'~Defi-N / Defi-B



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



Operating conditions.



0



Storage environment:



-20 7 0 5 0 0 hPa



Dimensions.



4 0 x 4 8 1 ~2cm(wxdxh)



Welght:



9 kg



+



1 0 In reserve ( 3 6 0 Joule)



4 0 OC, 3 0 9 5 % re1 humidity but without condensation 7 0 0 hPa 1 0 6 0 hPa 9 5 % re1 hum~dlty,but wlthout condensation 1 0 6 0 hPa



"C 2 0



Subject to alterations.



Delivery specification Part no. 90427 consists of



1 1 1 1



Conduciive gel 6 0 g Medical device protocol Instructions for use Briefing protocol



Accessories Part no. Bag w ~ t htwo transparent storage compartments Conductive gel, 6 0 g



14467 13026



PRIMEDICTM Defi-N / Defi B



instructions for use



7.3 Symbols



The followng symbols are used on the device:



Rating plate:



Protection type II



IPX 1



Drlp-proof (Defi-N)



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



/ 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



20



Charge energy



Place addles



Discharge energy Give shock



System error1 Def~br~llation impossible!



Instructions for use



8.



PRIMEDIC-h'Defi-N / Defi B



Conditions of Guarantee



- -f the manufacturer, METRAX grants a guarantee on this dev~cefor 2 years startng with the 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 nluscle (e. g. atrial fibrllat~on)



synchronized defibrlllatlon (cardloversion)



completely uncoordinated actlvltles of the heart muscle (ventr~cularflutter)



Unsynchron~sedd e f ~ b r ~ l l a t ~ o n



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 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.



of



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 betweethe 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 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



9.



PRIMEDIC~~ Defi-N / Defi-B



A2



Instructions for use



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



PRIMEDIC~~ Defi-N / Defi B



Instrucl:ions for use



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 -ne safety ~ c - - ~ must ~ 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 -: 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 BT1 P-140scs



BT2 P-140scs



BT3 P-140scs



BT4 P-140scs



1



+



BT9 P-140scs BT5 P-140scs



BT6 P-140scs



BT7 P-140scs



BT8 P-140scs



RT1 NTC PHILIPS 640 100k



J3



BLUE



1



BT10 P-140scs



BT11 P-140scs



t



CON1 J4



t



BLUE



RT2 NTC PHILIPS 640 100k



1 CON1



BT12 P-140scs



J2



BLACK



1



-