Home

Operating Instructions

1. 5 2 Intended use 6 DA WNOICA ONS eere E EE EE E N 7 Z LON nd 018 e E N E A 7 3 Safety advice 8 3 1 General GOV ICC vier tasisierectenscirnderzaisviaacereedancgetiedenneeesbedentnsatdducedeedaasbsveddnceteuderiaoesderadeedenss 8 3 2 Genefal safety GO VIC C sacs tee sane ssacectacscenatadeacuant necayidateadsabiescayats diacsatyicaniea pte diadsataeeeyatiais 9 3 3 Safety advice for you the 04561 ics ccacccanetssssaunctesesidasiadsnsirscanatadiacnoseviseaniadiadedeairienaiasax 9 3 4 Safety advice for protection of the patient sesssssrrrseesrsrrrrrererrrrrrreeersrrrrreeeerrrens 10 3 5 Safety advice for the protection Of third 0 605 11 1 11 3 6 Safety advice for the protection Of the 06166 11 4 Description of device 12 4 1 General description isienssrapsiasrarsieanseavsaapidesias eras sastiGieneortematarmaiensartanernysasie 12 4 2 Description of device details cccccscccccsseeecceceseececeseeeeeeesseeeeeeeeseeeeeeeesaeseeeeesaeaseess 13 4 3 ICONS IN the status display 11
2. 67 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Guidelines and manufacturer s declaration Electromagnetic emissions The PRIM EDIC HeartSave is designed for operation in an environment as described below The customer or user of the PRIM EDIC HeartSave should ensure that it is used in an environment of this kind Test for interference resistance IEC 60601 impulse test Electromagnetic environment code of practice 000 level Portable and mobile radio transceivers should not be used any closer to the PRIM EDIC HeartSave including its cables than the SSE HF interference V or Not 0 aa 1006 900 150 kHz to 80 MHz DO SEn recommended protective distance which is outside the ISM bands calculated according to the equation applicable 3 Ver for the transmission frequency 150 kHz to 80 M Hz a Recommended protective distance outside the ISM bands _ 35 rp Radiated HF disturbances 10 V m 10 V m for yy according to IEC 61000 4 3 80 MHz to 2 GHz battery V2 P WP for 80 M Hz to 800 M Hz 2 lyr for 800 M Hz to 2 5 GHz With P as the maximum power rating of the transmitter in W atts W in accordance with information provided by the manufacturer of the transmitter and d as the recommended protective distance in metres m The field strength of stationary radio transmitters should be less than the conformance level in accordance with an onsite insp
3. 6 7 Charging the AkuPak in the optional PRIM EDIC Charger Basis Charger Comfort Please refer to the separate operating instructions for the charger Basic Comfort 6 8 Connecting up the PRIM EDIC PowerLine optional accessory Fig 17 PRIMEDIC PowerLine Procedure Insert the PowerLine as described in Chapter 6 3 Then plug the mains plug of the mains cable into a socket in the vicinity of the patient The HeartSave carries out a self test and is then ready for use M ETRAX GmbH recommends that you keep the HeartSave unit with the PowerLine Note inserted continuously connected to the mains so that the equipment self tests are carried out automatically 29 GB HeartSave 6 6S 21230 GB F02 ae PRIMEDIC Sans Lite Georges 30 Preparatory measures before initial start up 6 9 Periodic device self test 6 9 1 Self test after switching the HeartSave on The device self test is run through automatically by switching on the PRIM EDIC HeartSave or by inserting the power module in the device to check all important functions and signal setups Automatically full sel test is initiated in case an internal error is found by the equipment Please proceed to follow the device instructions 6 9 2 Periodic self test p 0099 00 00 SHO RT Daily Software operating membrane ECG calibration clock internal voltage supply and HV section at 0 V M EDIU M First day of the month
4. DANGER When doing so pay attention to the following e If parts of the housing or insulation are damaged they must be repaired or replaced immediately If parts of the housing or insulation are damaged you should either refrain from using the device or switch it off immediately Have the device repaired as soon as possible by the manufacturer 12 3 Dispatching the PRIM EDIC HeartSave If the PRIM EDIC HeartSave has to be returned for servicing or to be upgraded then the power module must always be removed from the device and must be sent in with the device but packaged separately Protect the contacts of the power module with insulating adhesive tape W here possible use the original box 12 4 Disposal In accordance with the founding principles of the company M etrax GmbH your product has been developed and made using high quality materials and components which are recyclable At the end of its service life recycle the device through disposal companies registered under public law council recycling facilities Proper disposal of this product helps with environmental protection Through the registration of M etrax GmbH with the responsible authorities we ensure that disposal and recycling of electrical devices introduced by us onto the market in accordance with the EU Directive on the disposal of waste electrical and electronic equipment WEEE directive is guaranteed For Germany in accordance with the law o
5. gt gt lt lt List of available profiles The profile that is currently active is marked as active by the entry identified by the entry active Lower limit Upper limit On Off Lower limit Upper limit On Off 0 25 50 75 100 Display channel 1 Display channel 2 0 25 50 75 100 On Off On Off 0 25 50 75 100 1 5 from 40 to 120 ERC AHA depending on language packages installed in format DD MM YYYY 00 00 in 24 hour format 50H2 60H2z Off 0 degrees 180 degrees 33 SE PRimenic 34 Using the device Page 6 New PIN PIN Repeat Change PIN Save to profile PIN Profile selection Page 7 ARM SW DSP SW M SP SW ULF Serial No Page 8 BQ SW Version BQ serial number 0000 9999 0000 9999 Confirmation for Change PIN This is used the save the parameters in the selected profile Input box for current PIN for PIN changes and profile saves 0000 9999 Basic Profile 1 Profile 2 Profile 3 x xx Version number xxxxxxxx check sum 8 digits Date x xx Version number xxxx Check sum 4 digits Date x xx Version number xxxx Check sum 4 digits Date Check sum 8 digit XXXX 7 3 1 Simple change to configuration example Time Note After entering the setup menu by pushing the button lt the M an M ode AutoSync is marked To change the time proceed as follows Navigate the cursor by pressing the key W d
6. cccccsseeeseeeseeeeeeeesseeeeeees 34 7 3 2 Changing the PIN vusrcecasiserstinccnarciconieaatetounetiienucnaet ccc alonmnnavieataacticawalenmaneneeimte 35 7 3 3 Calling up activating a profile ssssssssssessssrrrrnnnsssrrrrnnnssrrrrrrnesrrrrrreeersrrrrreee 35 7 3 4 Saving menu parameters in a single 0 01116 0 1 36 TA NINN a E E E A E E 37 TAA FCE AIA araa E E ha otantamenme agua arased 37 Ti YEA e EEE RE E Ea 37 TAS SPO AIOI ara E EE EAA S EET A 38 8 Positioning the electrodes 39 8 1 Undressing Me patent ensinos cee asrina r EN E ET EA EE 39 8 2 Positioning the defibrillation electrodes SAVePAadS sseesesccseeeeeeeseeeeeeeesaeeeseeteas 39 8 3 Checking thE Ski grtaeiaaescavtaemeeremeimeiayseueutenteetansnieltieucieaeneviemesinueartneneravedt 40 8 4 Positioning the ECG adhesive electrodes seesserrrsseesssrrrrnresssrrrrnrenssrrrrrreessrrrrrree 40 8 5 Connecting the 1601 00965 esirin 41 8 6 lt Plug in electrode 01405 gt esssssssseeessrrsrresssrrrrrrensrrrrrnrensrrrrnrenssrnrrrrenrnnrrrrensrrnrerree 42 8J Check electrodes ariassan aeia yaaa er eee 42 9 Operation in Automatic Mode 43 9 1 Voice prompts by the device Preliminary examination of the patient ERC 43 9 2 Performing the ECG analysis in Auto M Od ccccccseseeeeeeeeeeeeceeseeeseseesaeeeeeeesaneeeeeeas 43 9
7. 17 aA 0 N eee ee ree ee eres entrant eee eee ee et nee Peete er er ern eee rrr errr ee eet ee 18 4 5 Datamanagement ecserin esia E iE SEN EEEE E EE IAE 19 5 Description of the accessories 20 Pal SS E E O E nae iene E E 20 5 2 Two pin patient cable for ECG recording optional accessory 20 5 3 Three pin patient cable for ECG recording essssssssesssrrrsreessrrrrrrressrrrrrrressrrrrrrreesrerrns 21 54 SP0 sensor OMIY ON HEanSAvVE 05 0 1 21 6 Preparatory measures before initial start up 22 OL UNPA NO eau E naan nme enact 22 6 2 Inserting Replacing the SaveCard seessssrrrsresssrrrrsrrnsssrrrrrnnntrrrrrrenserrrrrrenssenrrrree 22 6 2 1 Inserting the SaveCard ccceescccessesecceaueeeeeceaeeesecesauauseessauauseetsaeauseetsasaeess 23 6 2 2 Replacing the SaveCard sssssssssessssrrrrrrnsserrrrrrensssrrrrrensserrrrrennerrrrnresrrnrrrree 23 6 3 Inserting replacing the energy MOUIE ccccccccccssseseeeeeeeeeeeeeeeeeeeeeeesseeeeeeeeeeesaaeeses 23 6 3 1 Inserting the power MOUIE cccecccccesseeeeeeeseeeeeeeaeeeeessaueuseetsaeaueeetsaeaeess 24 6 3 2 Removing the power module from the device cccseeeeeccseseeeeeeseeeeeseesaneeeess 25 6 4 PRIM EDIC battery 6 DUONG acsinneorernctiennevncnstavns nerinaanke even naguaierntintanta cies 26 605 PRIM BO
8. Only use new adhesive electrodes and check that the use by date has not expired 41 GB HeartSave 6 6S 21230 GB F02 LA PRIMEDIC Somes Lil Exonrgurlanen 42 Positioning the electrodes Note In the device variants with SpO 2 the text display is disabled 8 6 lt Plug 10 electrode plugs gt BE PRIMEDIC HeartSave Fig 21 Inserted electrode plug connector 1 Electrode plug connector with cable 2 Locking pin 3 Socket Procedure Insert the plug connector 1 of the electrode cable in the HeartSave socket 3 Make sure that the locking pin 2 clicks into place To be able to unplug the electrode plug you have to push firmly on the top part of the locking pin while at the same time pulling the plug up 8 Check electrodes If the units advises lt Check electrodes gt in the display by verbal message this can have several causes e Electrode plug not plugged in e There is contact or a conductive gel connection between the defibrillation electrodes e Hair growth on patient not removed e Air pockets between skin and defibrillation electrodes cause a bad contact e Dried out electrodes Remedy the cause of the fault Instructions HeartSave 6 6S 21230 GB F02 Operation in Automatic 14 ode 9 Operation in Automatic M ode Reanimation 15 carried out in the device in accordance with the current recommended ERC AHA guidelines The device is ready for use after it has
9. W arranty claims made by the buyer against the seller dealer are not affected by this guarantee In the case of a warranty claim please return the device with proof of purchase e g invoice stating your name and address to your dealer or to M ETRAX M ETRAX After Sales Service is glad to be at your disposal even after the warranty period has expired Instructions HeartSave 6 6S 21230 GB F02 Depiction of the current time function 15 Depiction of the current time function The following shows the graph shapes of the defibrillation impulse in manual mode depending on the load resistance Time ms Time ms Time ms First shock Second shock Third shock o Foc N z a A LO lt ee N S 57 GB HeartSave 6 6S 21230 GB F02 LA PRIMEDIC Depiction of the current time function Third shock Second shock First shock 125 Ohm I A 150 Ohm I A Third shock First shock 175 Ohm Below you can see the graph shapes of the defibrillation impulse in manual mode depending on the load resistance Time ms Time ms Time ms 50 Joule 25 Ohm 50 Joule 50 Ohm 50 Joule 75 Ohm 40 oe Instructions HeartSave 6 6S 21230 GB F02 Depiction of the
10. at which the PRIM EDIC HeartSave is being used exceeds the conformance levels for HF listed above then the PRIM EDIC HeartSave should be observed to prove that it is functioning as intended If unusual performance characteristics are observed then it may be necessary to take additional measures such as change the orientation or the location where the PRIM EDIC HeartSave is being used fe Instructions HeartSave 6 6S 21230 GB F02 Guidelines and manufacturer s declaration Electromagnetic emissions Recommended protective distances between portable and mobile HF telecommunication devices and the PRIMEDIC HeartSave The PRIM EDIC HeartSave is designed for use in an electromagnetic environment in which the HF interference is controlled The customer or user of the PRIM EDIC HeartSave can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices transmitters and the PRIM EDIC HeartSave independently of the output power of the communication device as shown below Power rating of transmitter Protective distance depends on the transmission frequency m 80 M Hz to 800 M Hz 800 M Hz to 2 5 GHz a a 2 El For transmitters with a maximum power rating that is not given in the table above the distance can be determined by using the equation that belongs to the respective column whereby P is the maximum power rating of the transmitter in W at
11. charge cycle In practice this can be done in several ways e If the battery has only been slightly discharged do not recharge it immediately There 15 usually still enough energy available that you can continue to work with the remaining energy at a later point in time The PRIMEDIC ClipCharger does not always charge a rechargeable battery immediately Only once it falls below a certain threshold is the battery charged e The optimum way to achieve this 15 with a fully automatic discharger charger which performs defined discharging before every charging process For safety reasons this charging technique is not used for batteries that are charged in the defibrillator directly O therwise the unfortunate case could occur that the defibrillator is needed just at the moment in time at which the battery is fully discharged The fully automatic discharge charge device has been realised as a care function in the PRIM EDIC Charger Comfort available as an option This optional accessory it can also be retrofitted allows you to charge a second PRIMEDIC battery pack and the Care Function prevents the occurrence of the Memory effect Instructions HeartSave 6 6S 21230 GB F02 General instructions and rules for using the optional AkuPak Other effects of rechargeable batteries Batteries have two additional properties in daily practice e Self discharge e Deterioration after prolonged use In practice self discharging o
12. current time function 50 Joule 100 Ohm 50 Joule 125 Ohm 50 Joule 150 Ohm x 5 100 Joule 50 Ohm 6 x 20 100 Joule 75 Ohm 5 40 100 Joule 150 Ohm 4 lt x 5 30 200 Joule 50 Ohm 200 Joule 75 Ohm 200 Joule 100 Ohm i 4 A 59 GB HeartSave 6 6S 21230 GB F02 a PRIMEDIC Depiction of the current time function 200 Joule 125 Ohm 200 Joule 150 Ohm 200 Joule 175 Ohm I A 40 10 300 Joule 25 Ohm 300 Joule 50 Ohm 300 Joule 75 Ohm I A 40 300 Joule 150 Ohm i j 45 300 Joule 175 Ohm 360 Joule 25 Ohm 360 Joule 50 Ohm lt x 45 5 10 40 360 Joule 75 Ohm 360 Joule 100 Ohm 360 Joule 125 Ohm lt x at Instructions HeartSave 6 6S 21230 GB F02 I A GB HeartSave 6 6S 21230 GB F02 Rhythm detection system 360 Joule 150 Ohm 20 360 Joule 175 Ohm 46 10 5 9 5 0 5 10 1 20 59 5 10 1 20 ater ot 48 Latent 10 T 16 Rhythm detection system The rhythm detection system on the PRIM EDIC HeartSave analyses the patient s ECG and supports it if the unit detects a shockable or non shockable rhythm The device s rhythm detection sys
13. environment code of practice HF emissions according to CISPR 11 Group 1 The PRIM EDIC HeartSave only uses HF energy for its internal function This means that its HF emission is very low and it is unlikely that electronic devices in the vicinity are disrupted HF emissions according to CISPR 11 Group 2 The PRIM EDIC HeartSave must emit electromagnetic energy to carry out its intended function efficiently Neighbouring electromagnetic devices could be influenced FHF emissionsaccoringto seri cess The PRIM EDIC HeartSave is suitable for use in all facilities IEC 61000 3 2 battery including residential areas and those directly connected to a Transmission of voltage fluctuations Not applicable for public supply network which also supplies buildings used for ae Instructions HeartSave 6 6S 21230 GB F02 Guidelines and manufacturer s declaration Electromagnetic emissions The PRIM EDIC HeartSave is designed for use in an environment as described below The customer or user of the PRIM EDIC HeartSave should ensure that it is used in an environment of this kind Test for interference IEC 60601 impulse test Conformance Electromagnetic environment code of practice resistance level level Discharge of static 6 kV contact discharge Floor should be made of wood or concrete or be electricity ESD 8 kV air discharge tiled with ceramic tiles If the floor is covered according to IEC 61000 with a synthetic material
14. gt Fig 6 PRIMEDIC HeartSave 6 65 status display 1 Status display 15 GB HeartSave 6 6S 21230 GB F02 LA PRIMEDIC Saar Exper gurlan Description of device Fig 7 PRIMEDIC HeartSave 6 6S device cover with kit holder 1 Device cover 2 Kit holder with quick start guide face shield and razor 3 SavePads 4 Rubber gloves O perating Instructions HeartSave 6 6S 21230 GB F02 Description of device 4 3 Icons in the status display Measures to be taken OK Passed device self test e Device ready to use Battery battery pack capacity Is EE sufficient _ Battery battery pack 15 Equipment can be used it may be O K discharged necessary to charge or replace the battery AkuPak Insert battery AkuPak Passed device self test Icon also appears when no power module has been fitted Check use by date if necessary Symbol also appears if the use by replace with new ones date of the power module has been exceeded Device may be defective Carry out large self test by replacing the battery AkuPak or by switching the equipment on again Have the device repaired by a dealer Device defective Battery battery pack 15 Equipment can be used it may be discharged necessary to charge or replace the battery AkuPak Carry out large self test by replacing the battery AkuPak or by switching the equipment on again Device may be defective Have device repaired by Devi
15. of third parties DANGER Give loud and clear warning to people in the vicinity before the defibrillation to stand clear of the patient and have no contact with the patient 3 6 Safety advice for the protection of the device Repairs changes extensions and installation of the PRIMEDIC HeartSave 6 6S may only be carried out by personnel authorised and trained by METRAX The PRIMEDIC HeartSave 6 6S does not have any parts that can be repaired by the user The device may only be equipped and operated with original accessories from PRIMEDIC Clean the device only when it is switched off and the electrodes are unplugged 11 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Saunas Lilie Georges Description of device Description of device 4 1 Note General description The PRIM EDIC HeartSave 6 65 is an automatic external defibrillator with an integrated 6 channel ECG and manual defibrillation mode The ECG can be recorded either using the PRIM EDIC SavePads or the three pin patient cable In automatic mode Auto M ode the ECG is analysed with the implemented algorithm If potentially fatal cardiac arrhythmia Is detected the device generates the electrical shock required to resuscitate the patient and recommends defibrillation An electrical shock is not generated if the device does not detect a rhythm requiring defibrillation In manual mode either the doctor or the user decides whethe
16. power module Standards for licensing in the EU the corresponding harmonised European standards EN were used instead of the IEC standards IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 1 2 2001 IEC 60601 2 4 2002 EN1789 2003 Subject to technical changes without notice 55 SE PRimenic 56 Warranty conditions 14 Warranty conditions The warranty period is 24 months and starts on the day of purchase Please keep the invoice as proof of purchase Within this time period M ETRAX will remedy any defects in the device free of charge if they are based on material or manufacturing errors The device can be reinstated to its original condition as selected by M ETRAX either by repair or replacement A claim under warranty does not extend the original warranty period Warranty and also legally entitled warranty claims are not applicable if the usefulness of the device is only negligibly affected or in the case of normal wear and tear e g consumables such as AkuPak or damage caused after transfer of risk as a result of incorrect or negligent handling excessive wear or are caused by special external influences which are not provided for according to the contract The same applies if inappropriate changes or incorrect repair work 15 carried out by the buyer or by a third party All other claims against M ETRAX are excluded out unless such claims are based on intent or gross negligence or compulsory legal liability standards
17. pulse oximeter determines the 500 value oxygen saturation by means of an optical measurement This measurement uses different wavelengths of light that are transmitted through tissues and vessels The blood components that are important in an SpO measurement are oxygenated oxygen saturated haemoglobin and deoxygenated haemoglobin without oxygen those components that are vital for supplying oxygen to the Organism Transmitter and receiver elements in an SpO sensor are used to transmit light through body tissue and vessels The amount of light that reaches the receiver side depends on the level of oxygen saturation in the blood Very accurate measuring of the SpO value is enabled by means of precise modules and calibrated sensors The sensors are most commonly attached to the following measurement sites e Fingertip e Toe e Earlobe e Heel W hy are different sensors used Different sensors must be used for different patients for measurements to be carried out accurately and reliably The following factors should be taken into account when selecting the sensors e Patient s weight e Patient s activity e Duration of measurement e Blood circulation in extremities e Possible location of measurement e Patient s condition e Sterile measurement required Obviously there is no one sensor that can fulfil all of the criteria some of which are conflicting The 500 sensors focus on particular tasks As an example here we wil
18. the direction of the arrow 1 into the device until it makes contact with the back 3 of the device as shown in the diagram push the power module forward in the direction of the arrow 2 into the slot 1 until the release button 4 locks the power module tongue 5 securely into position Press the power module completely into the device until you hear the click when it Slots into place and the power module is flush with the outside edge of the device The power module must not fall out when the device is moved if it does it is not properly secured Instructions HeartSave 6 6S 21230 GB F02 Preparatory measures before initial start up Once the power module has been correctly inserted the device starts automatically and runs a self test Now follow the acoustic visual instructions from the device and then switch it off Now the device Is ready to use Note M onitor the Status Display If the display is showing OK the device is ready to use If the display does not read OK or if a fault message appears on the monitor remedy the cause or contact your nearest service station 6 3 2 Removing the power module from the device Fig 14 PRIMEDIC HeartSave 6 6S removing the power module 1 Release button 2 Power module tongue 3 Power module Replace the power module only when the device is switched off and the defibrillation electrode cable is disconnected Procedure Lay the device o
19. the relative air 4 2 humidity should be at least 30 Rapid transient electrical 2 kV for AC powerlines Not applicable The quality of the supply voltage should disturbances bursts 1 kV for incoming and for battery correspond to that of a typical commercial or according to IEC 61000 outgoing lines hospital environment 4 5 Surges according to IEC 1 kV normal mode Not applicable The quality of the supply voltage should 61000 4 5 voltage for battery correspond to that of a typical commercial or 2 kV common mode hospital environment voltage Voltage dips short lt 5 U gt 95 dip in Ut Not applicable The quality of the supply voltage should breaks and fluctuations for period for battery correspond to that of a typical commercial or in the supply voltage 40 U 60 dip in U hospital environment If the user of the according to IEC 61000 for 5 periods PRIM EDIC HeartSave requires continued 4 11 70 U 30 dip in U functioning even when disruptions in the power supply occur it is recommended that the PRIM EDIC HeartSave is fed from a power supply free of disruptions or a battery for 25 periods lt 5 U gt 95 dip in Ut for 5s M agnetic field at the M agnetic fields at the mains frequency should supply frequency correspond to the typical values found in a 5060 Hz according to commercial or hospital environment IEC 61000 4 8 Note U is the a c supply voltage before applying the test level
20. to the patient the heart rate displayed is that determined from the SPO signal Accordingly the equipment ECG VF Alarm and SPO Alarm differ After switching on the PRIM EDIC HeartSave 6 6S the alarms are always activated The alarm limits can be specifically configured by the user in the Setup menu and are retained after the monitor has been switched off Alarms are generally acoustic and visual depending on the operational situation there can be deviations which are explained in the following chapters ECG Alarm The range of adjustment of the ECG Alarm is from 30 300 beats per minute bpm The lower alarm limit can be selected in the range 30 99 beats per minute The upper alarm limit cannot be lower than the lower limit and the value selected can be up to 300 beats per minute The lower and upper alarm limits are displayed on the monitor Changes can only be made in the Setup menu When one of the set limits is attained an ECG Alarm is initiated If no valid heart rate can be obtained e g on the occurrence of an asystole cardiac arrest an alarm 15 likewise initiated In this case the heart rate is indicated in the form of dashes The Alarm in the event of an asystole cardiac arrest and on exceeding the set ECG limits takes the form of a loud tone alternating quickly between 2 pitch levels of approx 5 seconds duration This alarm is repeated every 20 seconds At the same time a bell symbol and the heart rate flash on the dis
21. 0 J 200 discharges at 20 C with a new battery 6 at any energy of 360 J 12 3 seconds in manual mode with fully charged new AkuPak 12 3 seconds in manual mode with an AkuPak after energy removals for 15 shocks lt 23 seconds from the start of the analysis up to readiness to shock with maximum energy after energy removals for 15 shocks lt 37 seconds from switching on the unit up to readiness to shock with maximum energy after energy removals for 15 shocks 2 derivations from Il Ill aVL aVR aVF 30 300 min accuracy 1 min or 1 CF class for 2 pin patient cable defibrillation proof 53 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC 54 Technical Data Input resistance CM RR Input d c voltage Bandwidth SpO NELLCOR pulse oximetry module Indication range Calibration range Accuracy W avelength Infrared Light intensity Operating mode Refresh time Impedance measurement Defibrillation M onitoring M easurement frequency Alarms System Physiological Analysis duration Monitor M onitor type gt 5 MOhm 10 Hz gt 85 dB 0 5V 0 5 40 Hz 3 dB SR 101 samples s 100 0 100 50 5002 Adults 100 70 2 digits Newborn infants 95 70 3 digits Contact the manufacturer for more details about test procedures Red 660 nm Infrared 920 nm 0 5 lumen cm2 Continuous lt 2 Secs 23 200 Ohm accu
22. 3 Defibrillation required ccccccccssseecccceeseeeeeeauseeeeeeaeeseeessaeeeseeesaesueeeesaeaeseetsaeeeseetegs 44 9 4 Defibrillation not required ccccccssssccecsseeceeeeseeeeeeaeeeeeeesaeeueeeseaeseseetsanaeeeetsaneeneetes 45 9 5 Keeping the defibrillator ready fOr 456 00 1 46 10 Operation in Manual Mode 46 10 1 Performing Cefibrillation cccccccccssssecccecsseeeceeseeeeeeeeeeeeseeeeeeeeseeseaueuseetsaeanseetsanansess 46 10 2 PA NC arc araceil ected parade E E 48 10 3 Keeping the defibrillator ready fOr USC ccccecsececesssseeeeeeeeeessseeseeeeeeesseaaseeeeeeesaagaess 49 11 Attaching the SpO sensor 49 11 1 Connecting the 500 2 SCNSOF sicvsscssinesedeetavasccnssesetdeaasnnaiedcenndandawasiveicadhddiasvesavedeaneadenin 50 12 Cleaning maintenance and dispatch 51 DZD VSG III e thease casicre wes tears dingats easeaninen calicumimiansenedseauvetrane vain seni 51 TZ 20200 na EEE E E E AAE E A E 51 1221 Servicing Meck Tensi e dentoosaameatdamncte 51 12 3 Dispatching the PRIM EDIC HeartSave ccccccseseccesseseceeseeeecesaeseeeeesaeaeseessananeees 52 P MTS OSG E E E E A E E E E T T E E E E 52 13 Technical Data 53 14 Warranty conditions 56 15 Depiction of the current time function 57 16 Rhythm detection system 61 17 General advice for using pulse oximeters 64 18 Guid
23. AutoSync operating mode Is selected Press the 4 key again the M an M ode AutoSync operating mode is activated 10 1 Performing defibrillation In contrast to Auto Mode during which the device programme s algorithm analyses the ECG and proposes defibrillation in manual mode you must analyse the ECG yourself for a shockable rhythm You decide whether defibrillation is required and when it should be initiated Fig 22 Primedic HeartSave 6 6S trigger button 1 Energy loading button 2 Trigger button for shock Instructions HeartSave 6 6S 21230 GB F02 Operation in 14 anual M ode Procedure First use the two arrow keys to select an appropriate energy level for defibrillation The energy levels for 50 100 200 300 and 360 joules are displayed on the right hand edge of the screen The energy setting 15 confirmed when the selected energy level is displayed in an inverse mode on the monitor The energy level required for defibrillation cardioversion depends on the patient their height weight and condition Press the energy loading button 1 The selected energy level is loaded when you press the energy loading button it is thus available to be applied as a shock through the SavePads The recorded message says lt Device is charging gt once charging is complete the green trigger button 2 lights up If the wrong energy level was selected by mistake and if this energy has already been loaded for de
24. CHER LLOYD in accordance with Certificate No 75 449 09 HH Instructions HeartSave 6 6S 21230 GB F02 Introduction 1 7 Pictograms on SavePads Not to be reused Expiry date ro amp remove hair Batch ID x cjg remove protecting Only for adults Cy cover REF Order number Storage temperature information in Celsius and Fahrenheit put the plug in TOZ ww as nO TRON F ETA GB HeartSave 6 6S 21230 GB F02 PRIMEDIC Intended use 2 Intended use The HeartSave is designed for use in automatic mode by suitably qualified first aiders trained paramedics and doctors in their everyday clinical activities either within a hospital or in the preclinical area of emergency medicine Only doctors are authorised to use the device in manual mode It may only be used on patients who are unconscious and who are not breathing The device may be powered from different removable power modules Thanks to its compact light design the HeartSave can easily be transported in an ambulance with a patient The device is used to carry out transthoracic defibrillations The main application 15 defibrillation in asynchronous manual mode an additional application is the cardioversion for atrial fibrillation in synchronous manual mode The decision on whether delivery of a shock is required can be made either by the user in manual mode or automatically with the shock recommendation from the device
25. Cardiac rhythms used to test the rhythm detection system in the device For validation the following databases have been used AHA Database for Evaluation of Ventricular Arrhythmia Detectors 80 records with 35 min length each e MIT BIH Arrhythmia Database 48 records with 30 min length each European ST T Database 48 records with 120 min length each These databases contain ECG rhythms with ventricular fibrillation VF of varying amplitudes ventricular tachycardia and sinus rhythms with amongst others supreventricular tacjycardias atrial fibrillation flutter sinus rhythm with premature ventricular contractions PVC asystole and pacemaker pulses All records are valid for evaluation of the VT VF rhythm detector with respect to used electrode systems and ECG signal processing characteristics For validation the ECG was converted to an analog signal and put out to the device under test The detection result was than read back by the validation system and compared to the reference annotation As shockable rhythms in calculation we look at the characteristic values of the sections in the ECG datasets of the above databases which are marked with the PysioBank Annotationscode for ventricular flutter Begin End also refer www physionet org using the PhysioBank Annotationscode These segments also include ventricular tachycardias but these are not annotated seperately Hence they could not be considered in calculation of
26. DIC ClipCharger optional e with the PRIMEDIC Charger Basic Comfort Charger optional The integrated detection of charge endpoint detection protects the battery from harmful deep discharge If the battery charge is too low both a visual and an acoustic signal are issued In case an AkuPak 15 stored outside the equipment its charge status can be checked by pressing button 2 Instructions HeartSave 6 6S 21230 GB F02 Preparatory measures before initial start up Fig 15 PRIMEDIC AkuPak Battery charge indicator 1 Battery charge indicator 2 push button to activate battery charge indicator Battery charge indicator 1 means 00000 81 100 charged eee 4196 60 charges pe 0 110 20 charges When charging using the Charger Basis Charger Comfort the AkuPak is automatically charged up again fully if the level falls below 80 of the charge capacity This 80 limit can temporarily be made inoperative by pressing on push button 2 i e the AkuPak can be recharged even before reaching this limit This for example is practical if you wish to fully recharge AkuPak prior to next use independant of its current charge status After recharging the programmed 80 limit is operative for the next automatic full recharge Note Charging the AkuPaks outside the stipulated operating temperature can Note cause damage to the rechargeable battery A completely discharged battery must be charged for
27. G UIP 26 6 6 Charging the AkuPak with the PRIM EDIC 10 960 0 0 00010100 28 6 7 Charging the AkuPak in the optional PRIM EDIC Charger Basis Charger Comfort 29 6 8 Connecting up the PRIM EDIC PowerLine optional ACCESSOFY sosser 29 6 9 Periodic device self test skis faces samiainsennertisuinaniiadawiananenlesndcessecescnicstedcematetenineseeiqaaels 30 6 9 1 Self test after switching the HeartSave ON sessssssessrrenssrrrressrrrresrrrrreerrrreesres 30 09 2 Penodie sel ESTen a a Na A 30 7 Using the device 31 Jet SWECO ON O erna EOE 31 7 1 1 Switching the PRIM EDIC HeartSave 6 65 00 cccccccseseeeeeeseeeeeeeeseeeeeeessanens 31 7 1 2 Switching the PRIM EDIC HeartSave 6 65 Off cccceccsecsssseeseeeseeeeeseeesanees 31 7 2 Selecting the operating mode ccceccceccceesseseeeeeeeeeeseeeeeeeeeeeeseeeeeeeeeeeesaaeeseeeeeeeesaaenses 31 7 2 1 Automatic mode AUTO mode eee eeneeneeeeeeeeees 31 Ta Manua mode AUTO SYNC xiccussescnasssisienastesconsicisecanotesancyaid cacadatdtannuatioeestagens 32 7 2 3 Changing the operating Mode sssssrssseesssrrrrrensrsrrrrrressrrrrrrrensrrnrrrressrnrrrree 32 Table of contents es memes 160 60 1 210 eee oe eee ee een E een ee E reer ETE 33 7 3 1 Simple change to configuration example TIME
28. O Alarm The SPO Alarm is only available for equipment with SPO functionality The adjustment range for the SpO alarm is 70 100 The lower and upper alarm limits of the SpO value are displayed on the monitor Changes can only be made in the Setup menu When one of the set limits is attained a SpO Alarm is initiated The Alarm on exceeding the set SPO limits takes place in the form of a deep interval tone quickly alternating between 2 pitch levels of approx 5 seconds duration This alarm is repeated every 20 seconds At the same time the bell symbol and the SpO value flash on the display The SpO Alarm can be deactivated in the Setup menu When the ECG Alarm is deactivated the bell symbol is permanently crossed out If in this case the alarm limits are exceeded no acoustic alarm is initiated but the bell symbol and heart rate flash in order to inform the user DANGER There is no acoustic warnings 11 the alarms are turned off in case one of the monitored parameters is beyond the permissible range Hence regularly check the patients and the equipment indicators so as to react rapidly to changes Instructions HeartSave 6 6S 21230 GB F02 Positioning the electrodes 8 Positioning the electrodes 8 1 Undressing the patient If during your preliminary examination you have ascertained that the patient requires defibrillation undress the upper body so you can position the electrodes 8 2 Positioning the defibrillati
29. RIMEDIC Sans Lie Georgeranca Operation in Automatic 14 ode Note DANGER O bserve the patient during the entire reanimation It is possible at any time that the patient may regain consciousness and does not need to be defibrillated If that is the case do not carry out the defibrillation under any circumstances DANGER Take care that during the analysis phase the Auto switch Is not continuosly pressed as otherwise safety shutdown of the equipment 15 effected The rhythm identification detector continuously analyses the ECG even after a rhythm in need of defibrillation has been identified 9 3 Defibrillation required If the device clearly identifies VF it will recommend defibrillation for which automatic preparations are made inside the device The device announces lt Shock advised gt lt Device is charging gt lt Do not touch the patient gt lt Device is charging gt lt Do not touch the patient gt O nce the energy is built up it remains available for 15 seconds and is indicated by a continuous beep a green light on the trigger button and the recorded message lt Stand clear of patient Deliver shock now gt The remaining time is simultaneously displayed on the monitor If you do not defibrillate within this period an internal safety discharge will follow and the ECG will be analysed again DANGER Before pressing the trigger button ensure that all devices connected to t
30. Software operating membrane ECG calibration clock internal voltage supply and HV section at 300 V LONG On the 1st July and on the 1st January Software operating membrane each year ECG calibration clock internal voltage supply and HV section at 1 600 V FULL After identifying an internal error Software operating membrane ECG calibration clock internal voltage supply and HV part at 1600 V microphone test key Instructions HeartSave 6 6S 21230 GB F02 Using the device Using the device 7 1 Switching on off 7 1 1 Switching the PRIM EDIC HeartSave 6 6S on The device is automatically activated by removing its cover If the device is not to be activated automatically or if the device cover is not in use switch on the device by pressing the On Off button All buttons are then activated apart from the trigger button Triggering of defibrillation is only enabled in automatic mode once ventricular fibrillation VF has been identified Directly after switching it on an internal self test is carried out to check important functions and signal devices Standby is confirmed by a beep You must always wait for this beep 7 1 2 Switching the PRIM EDIC HeartSave 6 6S off You can switch off the device in different ways e By pressing the on off button for approx 3 seconds A warning beep will sound simultaneously This time has been chosen to prevent the device from being switched off accidentally e By
31. at least 2 hours If the charging time is too short incorrect interpretation of the rechargeable battery charge status may occur Trouble free functioning of the equipment can not be assured Charging the AkuPak is interrupted at temperatures of more than 45 C 27 GB HeartSave 6 6S 21230 GB F02 ae PRIMEDIC Soest Lids Exooryurlanen Preparatory measures before initial start up 6 6 Charging the AkuPak with the PRIM EDIC ClipCharger Fig 16 PRIMEDIC AkuPak with PRIMEDIC ClipCharger 1 2 3 4 5 Procedure AkuPak ClipCharger M ains plug green LED Power yellow LED Charge Removing the AkuPak from the device Position the ClipCharger on the AkuPak in accordance with Fig 14 Now plug the mains plug into a plug socket The green LED Power and the yellow LED Charge light up and signal Power Available Charging Is started if it becomes necessary because of the remaining residual energy The yellow Charge LED on the ClipCharger indicates charging Charging time Is approx 2 1 2 hours The yellow LED goes out when charging is complete pull the mains plug out of the plug socket and release the ClioCharger from the AkuPak Nickel Cadmium batteries are subject to natural wear and should be Note 28 exchanged at the latest after 2 5 years depending on the frequency of use Instructions HeartSave 6 6S 21230 GB F02 Preparatory measures before initial start up
32. atic mode Auto M ode To switch to manual mode follow the steps below Press the key once on the device The M an M ode AutoSync manual mode is selected press the key again the M an M ode AutoSync operating mode is activated The device is switched to the Auto M ode operating mode e after it is switched off and back on again e After you press the H key navigate in the Setup menu with the A key and confirm Auto M ode with the H key Instructions HeartSave 6 6S 21230 GB F02 Using the device GB HeartSave 6 6S 21230 GB F02 Setup menu Using the Setup menu you can change the operating mode and the parameters The setup covers several pages Refer to the device for these The device is pre configured in the factory You can change certain parameters in the Setup menu Your configuration will be retained until another change is made even if the device is switched off or if the power supply is replaced Parameters Page 1 Automatic mode M an M ode Autosync Page 2 Basic Profile 1 Profile 2 Profile 3 Page 3 Alarm SpO Alarm 500 Alarm ECG Alarm ECG Systole sound Derivation Volume Page 4 M icrophone BLS information CPR sounds CPR cycles Contrast Page 5 Guideline Language Date Time Network filter Display Selection options O ption between automatic mode AED mode and manual mode The currently active mode is displayed in brackets
33. be given 61 TE PRIMEDIC Rhythm detection system The Algorithm e Observes the ECG rhythm across a continuous recording of 10 seconds of which 7 seconds have been used for an initial diagnosis or to display the message Shock recommended e Measures the symmetry of the ECG signal by several wave form factors and area abive and below the moving average of the signal Shockable ryhthms show greater symmetry than non shockable rhythms e Measures the ratio of the signal energy content in a frequency band typical for shockable rhythms and the total of the signal energy content For shockable rhythms the signal energy concentrates 10 a specific frequency band and its fraction with respect to the total signal energy 15 higher e Derives from these two signal processing steps two parameters and compares them to a threshold If both parameters drop below their respective threshold for a specific amount of time the device will rate the heart rhythm shockable However if one of the parameters exceeds Its higher threshold value this shocking recommendation is retracted e Filters and measures artefacts and interference If a specific artefact level is exceeded no reliable signal analysis is possible and the heart rhythm is rated non shockable e Detects pacemaker pulses and removes them from the ECG signal before rhythm evaluation e Measures the heart rate If it drops below a threshold the heart rhythm is rated non shockable
34. been switched on a successful self test is performed and the operating mode Is selected Triggering of defibrillation is only enabled by the HeartSave in automatic mode once ventricular fibrillation VF has been identified 9 1 Voice prompts by the device Preliminary examination of the patient ERC You will be asked to examine the patient during the course of the Voice Prompts lt Talk to patient gt lt Call emergency services gt lt Open up airways carefully hyperextend head gt lt Check breathing gt lt If not breathing 30 times cardiac massage gt lt 2x artificial respiration gt lt Position electrodes gt lt Plug in electrode plugs gt Before applying the electrodes to the patient carry out the actions as Note instructed The instructions are automatically interrupted when you connect the electrodes to the patient 9 2 Performing the ECG analysis in Auto M ode If the defibrillation electrodes have been applied the device will automatically start the analysis The device prompts lt Do not touch the patient analysing rhythm gt DANGER During the analysis the patient must be put in an immobile position and must no longer be touched The algorithm of the device program will now check the ECG for ventricular fibrillation This process takes approx 7 12 seconds If the device identifies VF it will recommend defibrillation 43 GB HeartSave 6 6S 21230 GB F02 ma P
35. ce defective authorised dealer 17 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Description of device 4 4 Capacity display W ith the PRIM EDIC HeartSave 6 65 the battery charge of the battery battery pack appears on the display The different images that may be displayed have the following meaning cy 0 device runs on until charge is exhausted Fault in the device or service life of the power module has expired The battery pack and the battery are monitored by means of electronic charge measurement to ensure the most accurate capacity display possible In addition to this display the device issues a warning if the battery is about to be exhausted Audible warning Display on monitor AkuPak lt Charging status battery low Please Recharge AkuPak recharge gt Battery lt Battery low please replace battery gt Replace battery W hile the device is being operated the relevant voice prompt Is issued regularly in the selected language provided the volume has not been set to 0 The battery symbol in the status display 15 activated Instructions HeartSave 6 6S 21230 GB F02 Description of device 4 5 Note GB HeartSave 6 6S 21230 GB F02 Data management The device automatically records all ECG data and all spoken communication environmental sounds using a microphone if activated The max recording period is 17 hours The saved data can be displayed with th
36. closing the cover of the device e The device switches off automatically if it does not recognise a signal for 10 minutes and if no button key is pressed during this period e f the device detects a fault it will automatically switch off to avoid possible injuries 7 2 Selecting the operating mode The device offers two different operating modes e Automatic mode e Manual mode 7 2 1 Automatic mode AUTO mode Once it is switched on and after successful completion of the self test the device Is usually in Auto Mode In this operating mode the device performs an automatic heart rhythm analysis If potentially fatal cardiac arrhythmia is detected the device recommends defibrillation and generates the electrical shock required An electrical shock is not generated if the device does not detect a rhythm requiring defibrillation In this case the device recommends cardio pulmonary resuscitation reanimation 31 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC 32 Using the device 7 2 2 7 2 3 M anual mode Auto Sync W ith the M anual M ode operating mode the user is free to apply his or her experience and knowledge to the ECG results The user can choose the time of shock delivery and the shock energy In manual mode synchronous defibrillation cardioversion can be performed in addition to standard asynchronous defibrillation Changing the operating mode When switched on the Primedic HeartSave is always in autom
37. e menu parameters previously selected Confirm this with the key H Navigate with the key A to the entry lt PIN gt and confirm your selection with the key Enter the current PIN as follows Using the keys A W you can increase or decrease a digit With the key 1 you can change to the next digit After the fourth digit it jumps back to the menu O O 860 88 Change to the menu entry lt Save to profile gt and confirm your selection with the key On the right next to the cursor the entry lt OK gt should appear This means the profile is saved Now leave the menu by using the key W to navigate to the menu item lt End Setup gt and confirm this with the key 4 If you want to change the configuration that your device starts up with when it is switched on you have to save your changed menu parameters in the profile Basic Note You can only change the following parameters temporarily while the device is in Operation Alarm ECG Alarm 500 Network filter The following settings are always active after the device is started Alarm ECG On Alarm SpO On Mains filter O ff Note Instructions HeartSave 6 6S 21230 GB F02 Using the device 7 4 7 4 1 7 4 2 Alarms The PRIMEDIC HeartSave 6 65 depending on the version monitors the heart rate from the ECG signal and the oxygen saturation level of the patient from the data of the SPO sensor If the SPO sensor only is connected
38. e aid of a PC Laptop and the software ECG Viewer The dat Is evaluated purely for administrative or legal purposes and can not be used for diagnosis or treatment of the patient In the Software there is a deployment protocol in which additional patient data can be entered The data saved on the SaveCard should be archived externally after every deployment if possible The SaveCard should then be re formatted if possible instead of the usual deletion process Once the storage capacity of the SaveCard is exhausted no further data will be saved The PRIM EDIC HeartSave is ready for operation even if its memory is full and without a SaveCard The SaveCard supplied with the device is already formatted and can be used straight away If you have problems with the existing SaveCard or with a new CF card you must format these using the FAT16 file system for use in HeartSave W hen formatting ensure that you do not accidentally transfer the FAT32 file system from a Windows XP system To attain the highest possible degree of safety here please proceed as follows Windows 2000 Windows XP Windows Vista Start a command line window using Start gt Run and in the entry field enter cmd exe The command line window will then open There you enter the following format f U FS FAT X V where f stands for the drive letter which you may have to change SE PRIMeDic 19 Description of the accessories 5 Description of the acce
39. e defibrillator is stored in a rescue vehicle in the winter e Do not use the device if it is defective e g if the defibrillation cable is damaged e Only use the device with accessories wearing parts and disposable items which have proven to be completely safe to use by being tested by a testing authority licensed to test the device when equipped ready for use These conditions are fulfilled by all original PRIMEDIC accessories and wear parts e Use new undamaged defibrillation electrodes before their expiry date for every patient to avoid any possible burns to the skin e Connect the adhesive electrodes only using the PRIMEDIC HeartSave 6 6S Using the electrode system with other devices may result in the release of dangerous leakage currents on the patient e Do not use the device in the immediate vicinity of other sensitive equipment e g measuring equipment that is sensitive to magnetic fields or strong sources of interference which could affect the way the PRIMEDIC HeartSave 6 6S works Keep an adequate distance from other therapeutic and diagnostic energy sources e g diathermy high frequency surgery magnetic resonance tomography These devices can affect the PRIMEDIC HeartSave 6 6S and disrupt the way it operates For this reason disconnect the patient from the interfering devices During defibrillation disconnect the patient from all other medically used devices which do not have a defibrillation re
40. ection Interference is possible in the C vicinity of devices which have the following pictogram Note 1 At 80 M Hz and 800 M Hz the higher frequency range applies Note 2 These guidelines may not be applicable in all cases The spread of electromagnetic factors is affected by absorption and reflection from buildings objects and people The ISM frequency ranges for industrial scientific and medical applications between 150 kHz and 80 M Hz are 6 765 MHz to 6 795 M Hz 13 553 M Hz to 13 567 M Hz 26 957 M Hz to 27 283 M Hz and 40 66M Hz to 40 70 M HZ The conformance levels in the ISM frequency bands between 150 kHz and 80 M Hz and in the frequency band from 80 M Hz to 2 5 GHz are defined to reduce the probability that mobile portable communication devices can cause interference if they are unintentionally brought into the vicinity of the patient For this reason the additional factor of 10 3 is applied when calculating the recommended safety distance in these frequency ranges The field strength of stationary transmitters such as base stations of wireless telephones between 150 kHz and 80 M Hz and mobile field radio transmitters amateur radio stations AM and FM radio and television transmitters can theoretically not be precisely determined in advance To determine the electromagnetic environment with regards to the stationary transmitters a study of the location should be considered If the field strength measured at the location
41. ectrodes incorrectly or using electrodes that are of poor quality or too dry may result in device misinterpretations You should therefore only used ECG adhesive electrodes that have been approved by M etrax Instructions HeartSave 6 6S 21230 GB F02 Positioning the electrodes wW 8 5 Connecting the electrodes Fig 20 Removing the protective film 1 Protective film 2 Defibrillation electrode with gel layer The PRIM EDIC HeartSave 6 will give you a voice and text prompt to apply the defibrillation electrodes to the patient To do so follow the steps below First remove the protective film 1 from one electrode 2 and them immediately place the electrode on the position you had ascertained previously Proceed to remove the protective film from the second electrode and place it in its position smooth the electrodes onto the patient ensuring there are no air bubbles under the electrodes After the protective film is removed do not allow the electrodes to come into contact with the floor objects clothing or other parts of the body as this could remove the conductive gel layer on the electrodes A reduced layer of gel could cause burns on the skin under the electrodes during defibrillation Defibrillation can only be delivered if the patient is within the permissible impedance range See the chapter on technical data for more details You must therefore make sure that the electrodes adhere properly
42. elines and manufacturer s declaration Electromagnetic emissions 66 19 General instructions and rules for using the optional AkuPak 70 20 Safety checks 72 21 Using the equipment on ships 73 21 1 Use of PRIM EDIC HeartSave units together with a PRIMEDIC battery on ships in Memen Hantha y enia EN 73 21 2 Use of PRIMEDIC HeartSave units together with a PRIMEDIC AkuPak on ships in the CRC Ma NANY seesinane ia erna a E EEE 73 21230 GB F02 Table of contents Contact details 74 Introduction Introduction 1 1 Foreword Dear User You are faced with the task of using the PRIM EDIC HeartSave in a medical emergency on human beings So that you react quickly and properly in these special circumstances and make optimal use of the opportunity the device provides you with it is necessary for you to take your time and read through these operating instructions beforehand thus familiarising yourself with the device its functions and applications Keep these operating instructions near the device so that you consult any queries which may arise If you have any questions regarding the device or other PRIM EDIC products we would be glad to be at your disposal You will find our contact address on the masthead at the start of these operating instructions 1 2 Validity This operating manual describes the HeartSave 6 and HeartSave 6S defibrillators supplied by METRAX GmbH 1 3 Warranty The warranty period is 24 months a
43. f a rechargeable battery means that a full rechargeable battery is slowly but steadily losing its charge After around 4 weeks only around 90 of the capacity 15 still available This effect normally only need to be taken into consideration if several batteries have been charged in reserve Even with optimum maintenance a rechargeable battery is subject to deterioration after about 2 3 years depending on frequency of use After roughly 500 1 000 charging cycles depending on the type a rechargeable battery will no longer be capable of giving up the electrical energy absorbed to chemical storage The battery 15 thus rendered useless and must be replaced with a new one GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Saurs Lilie Georgerlanca 72 Safety checks 20 Safety checks it is possible that other national regulations may be applicable In accordance with the German M edical Products User Regulations M PBetreibV 6 safety checks the operator in the event of commercial and economic use undertakes to carry out regular checks or have them carried out M ETRAX recommends carrying out safety checks in accordance with the M PBetreibV 6 every 24 months The safety checks may only be carried out by or be assigned to the persons described in the M PBetreibV 6 4 The safety checks carried out are to be documented in accordance with M PBetreibV 7 In accordance with the German M edical Products User Regulation
44. fault occurs whilst the energy is being loaded an intermittent warning beep is sounded and the charge present in the capacitor is discharged within the device When the first message Charge battery appears you still have at least 3 energy discharges at max energy If this message appears you should replace the power module 47 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC 48 Operation in M anual M ode If the device is switched on and for 10 minute no ECG Is recorded or no key 15 pressed then the device will automatically switch off Approx 30 seconds before the switch off this is signalised by an interrupted warning tone Pressing any button or any other activity will end the switching off process If the electrodes are not connected a dotted line appears on the monitor in Note the basic state with the comment lt O pen electrodes gt As soon as a derivation via the electrodes occurs the ECG signal appears on the monitor 10 2 AUTO SYNC Unlike conventional defibrillators the HeartSave 6 6S has synchronisation AUTO SYNC that is automatically activated i e the synchronous markers are set for the QRS complexes as soon as the ECG clearly identifies an R wave Auto synchronisation is only possible in manual mode Synchronisation takes place using derivation II only You must ensure that the patient cable or defibrillation electrodes are not mixed up and stuck in position A clear QRS detection only occurs
45. fibrillation discharge the energy by pressing the energy loading button again The loaded energy 15 then discharged for safety reasons M ake a new energy selection and confirm it with the energy loading button The loaded energy cannot be adjusted The capacitor charge remains available for 15 seconds and Is indicated by a continuous beep and a green light on the trigger button If defibrillation does not occur during this period a safety discharge Is carried out within the device You can also cancel the Capacitor charge internally by pressing the energy loading button again during the 15 second period DANGER Before pressing the trigger button ensure that all devices connected to the patient are removed if they are not defibrillation protected Before and during the energy discharge all those participating in the reanimation must stand clear and all contact with the patient or conductive parts e g a stretcher must be avoided Press the trigger button to enable defibrillation which will occur immediately after the button is pressed After carrying out defibrillation you must analyse the ECG again for shockable rhythms and trigger another defibrillation or more if necessary or perform other resuscitation measures The energy level is reset to 50 joules Capacitor charging time for defibrillation depends on the available battery capacity Charging may take longer if the power module 15 partly discharged If a
46. fils during charging or in parallel charging mode the EMC requirements of the General Power Supply Zone 73 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Saurs Lilie Georgerlanca Using the equipment on ships Contact details METRAX GmbH Rheinwaldstr 22 D 78628 Rottweil Tel 0741 257 0 info primedic com www primedic com 74 gt gt gt gt gt gt Instructions HeartSave 6 65 21230 GB F02 About Us C ois
47. ger button is held down synchronisation does not take place the energy is discharged internally The energy remains in the Capacitor if the trigger button Is only pressed briefly and if defibrillation was not triggered by synchronous markers The amounts of energy used for cardioversion are usually less than for asynchronous defibrillation because depolarisation of all of the heart muscles is not required The amount of energy is roughly determined by the height and weight of the patient However the determining factors are the indications i e the following empirical values apply Instructions HeartSave 6 6S 21230 GB F02 Attaching the SpO 2 sensor Ventricular tachycardia with unstable 50 joules for additional cardioversions pulse select the next highest energy level 100 J 200 J 300 J supraventricular tachycardia 50 100 joules Atrial flutter 50 joules Atrial fibrillation 100 joules The above values are only recommendations for the procedure to use for the corresponding indications Ensure that R wave detection is continuous during cardioversion Eliminate any faults before starting cardioversion e g adjust the mains filter 10 3 11 Keeping the defibrillator ready for use At the end of a reanimation clean the device replace the SavePads and check or if necessary replace the power supply unit so that the device is ready to use again as soon as possible Charge the battery pack so that sufficient
48. he patient are removed if they are not defibrillation protected Before and during the energy discharge all those participating in the reanimation must stand clear and all contact with the patient or conductive parts e g a stretcher must be avoided Instructions HeartSave 6 6S 21230 GB F02 Operation in Automatic 14 ode Note Press the trigger button for defibrillation which will occur immediately after the button is pressed The request to perform Cardio Pulmonary Reanimation CPR is then issued Pressing the trigger key during power charging bevore it turns green does not result in release of shock rather it leads to internal safety discharge Capacitor charging time for defibrillation depends on the available battery capacity Charging may take longer if the power module Is partly discharged If a fault occurs whilst the energy 15 being loaded an intermittent warning beep 15 sounded and the charge present in the capacitor is discharged within the device For the first message Charging status battery low Please recharge or Battery low please replace battery there are still at least 3 energy discharges at max energy If this message appears you should replace the power module If when the device is switched on no ECG is performed for 10 minutes and no button is pressed the device automatically switches off Approx 30 seconds before the switch off this is signalised by an interrupted warning to
49. if the R wave is positive A synchronous shock is only delivered when sync appears in the display when the Charge button is pushed Therefore make sure that the display shows the window Sync before energy charging If an emergency situation calls for synchronous operation of the defibrillator cardioversion ECG markings are automatically displayed on the monitor screen To ensure safe synchronous operation these cardioversion markers in each Q RS complex must appear directly at an R wave A clear artefact free ECG signal with sufficient amplitude is required in this case If during a period of 10 seconds at least 3 R waves are not detected the unit switches to the synchronous mode The Sync window in the display changes to MAN A warning tone 15 emitted If then an adequate number of R waves 15 detected again the mode again jumps to Sync again The delay time between detection of a QRS complex synchronous pulse and energy transfer is less than 60 ms Before initiating cardioversion observe the monitor display to check that the cardioversion markers are clearly assigned to the R waves and not for example reacting to pacemaker pulses or artefacts In synchronous mode the trigger button must be held pressed until the cardioversion time is reached A beep is sounded during this period Cardioversion is not performed if the trigger button is released again in the meantime If within a period of 3 seconds whilst the trig
50. in AED mode In automatic mode the energy levels for the first second and third shock are specified by the maximum voltage setpoint values of 20A 25A and 30A and by the capacitor voltage determined by the patient impedance while in manual mode you can select energy levels between 50 360 to adjust the defibrillation energy appropriately in line with weight and the doctor s experience The device is also used to record and display electrocardiograms monitoring The derivation from the defibrillation electrodes is calculated in compliance with correct use of the electrodes from the Einthoven II derivation Dual channel monitoring is possible if you use an ECG cable instead of defibrillation electrodes and commercially available ECG electrodes A random appropriate selection of 2 signals from the Einthoven Il IIl or Goldberger aVR aVL aVF analogue derivations can be displayed Correct positioning is mandatory The operator is guided by spoken instructions and clear written and pictorial information After switching on the device the patient is connected to it using the enclosed adhesive electrodes After this automatic rhythm analysis is carried out by the device Only if arhythm is detected by the device as being ventricular fibrillation requiring a shock does it suggest treatment with a high energy shock All other rhythms are classified as not requiring a shock The time from the start of analysis until the shock is applied is
51. jected to the regular checks explained in the appendix According to the Ordinance on the O peration and Use of M edical Devices M PBetreibV a medical devices log needs to be kept for the device Regular checks of the device are to be documented in it For the other states in the European Community national regulations for operating medical devices apply 3 2 General safety advice DANGER You must not use the device in the vicinity of flammable materials e g cleaning solvents or similar or in an atmosphere enriched with oxygen or flammable gases vapours 3 3 Safety advice for you the user Only use the device on a patient if e you have ensured its operational safety before use and are certain that the device is in good condition e the patient s condition requires or permits its application Before using the device check whether it is in the operating temperature range This applies for example if the defibrillator is stored in a rescue vehicle Do not use the device if it is defective e g if the defibrillation cable is damaged GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Safety advice 3 4 Safety advice for protection of the patient DANGER e Use the unit on a patient only if you have made sure that functional safety and proper condition of the unit are present e Before using the device check whether it is in the operating temperature range This applies for example if th
52. l take the DS 100 A sensor or D YS by NELLCOR The DS 100 A is extremely rapid in use and can easily be slipped onto fingers of different thicknesses thanks its ingenious design The sensor is not suitable for children because of its shape Nor can it be used for patients who are moving vigorously because the casing design cannot prevent the sensor from slipping off the finger Since it has no casing the D YS sensor can be used for a greater weight range it offers more flexibility in terms of the attachment site and can be attached with adhesive tape this reduces the operation speed however Instructions HeartSave 6 6S 21230 GB F02 General advice for using pulse oximeters W hat factors can influence the SpO value Since measuring the oxygen saturation Is an optical procedure the following variables may affect the result e Direct sunlight e Strong ambient light e g OT lights e Infrared emitter e UV emitter bilirubin lamps Influence of these factors can be minimised by ensuring that the sensor is attached correctly and by covering the sensor with opaque material Other variables are e Dirt contamination of the measurement site e Inadequate cleaning of the sensor e Colour of measurement site is distorted or opaque e g nail varnish e Patient moving vigorously e Injected contrast agent e g indiocyanin green or methylene blue e High proportion of dysfunctional haemoglobin e g carboxyhaemoglobin e Inc
53. less than 30 s For safety reasons no shock is given with asystolia as no therapeutic effect is to be expected Controlled ventricular electrical activity caused by supraventricular tachycardia such as atrial fibrillation atrial flutter ventricular extra systoles and idioventricular rhythms does not lead to a shock being applied Following application of the shock the device carries out a new rhythm analysis Additional shocks are recommended if other rhythms ventricular fibrillation are present that can be treated with a high energy shock The user performs resuscitation using manual cardio pulmonary resuscitation in accordance with the applicable guidelines Any use above or beyond this 15 not considered as intended use and can lead to personal injury or damage to property Improper use of the defibrillator can lead to ventricular fibrillation asystolia or other dangerous dysrhythmia The operator of the HeartSave must ensure that the HeartSave Is only used by authorised specialist personnel Instructions HeartSave 6 6S 21230 GB F02 Intended use General note The guidelines governing the application of emergency treatment in the event of cardiac arrest may change The current device can be operated either on the basis of the International Guidelines 2005 Resuscitation 2005 6751 S7 23 by the European Resuscitation Council or on the basis of the American Heart Association AHA guidelines for cardiopulmonary resusci
54. n bringing electrical and electronic equipment onto the market taking back and disposing of in an environmentally friendly manner Electrical and Electronic Equipment Act ElektroG M etrax is registered with EAR register of old electronic equipment under the number 73450404 Improper disposal of the device or its individual parts can lead to injury For business customers in the European Union Please contact your dealer or supplier if you want to dispose of electrical and electronic equipment Your dealer or supplier will have further information available for you Instructions HeartSave 6 6S 21230 GB F02 Technical Data 13 Technical Data Defibrillation O perating modes Patient impedance Synchronisation Impulse shape O utput power in AUTO mode at Accuracy Impulse length Discharges Charge time ECG Derivation Heart frequency Input Asynchronous synchronous external in automatic manual mode 23 200 Ohm SYNC only in manual mode Biphasic current regulated CCD Patient impedance lst stage 2nd stage 3rd stage 25 Ohm 143 201 277 50 Ohm 281 350 360 75 Ohm 348 360 360 3171 All data is subject to a tolerance of 15 Positive phase 11 25 ms negative phase 3 75 ms 70 discharges at 20 C with a new fully charged recharageable battery at any energy of 200 J 50 discharges at 20 C with a new fully charged recharageable battery at any energy of 36
55. n its back and press the release button 1 in the direction of the arrow 1 until the tongue of the power module 2 is released and the power module 3 snaps out of the slot by a small distance Twist the power module slightly in the direction of the arrow 2 and then pull it in the direction of the arrow 3 out of the device 25 GB HeartSave 6 6S 21230 GB F02 ve PRIMEDIC Samm Exon yurlansn 26 Preparatory measures before initial start up 6 4 6 5 PRIM EDIC battery optional The battery is a disposable lithium battery It is fully charged when delivered This type of battery is state of the art and was selected due to its extremely long service life and energy storage DANGER On no account try to charge the battery There would be risk of an explosion Use the battery before its use by date expires After the equipment has been used the battery should if necessary be replaced by a new one so that the full period of operation will be available for the next deployment In any event heed the instruction leaflet enclosed with the battery and keep it safe with these operating instructions If the device has to be sent away to technical services remove the battery before sending it and put some adhesive insulation tape over its contacts When sending the battery observe the separate shipping regulations PRIM EDIC AkuPak You can charge the AkuPak in two different ways e with the PRIME
56. nd dispatch 12 1 Cleaning Only clean the device when it is switched off and with the electrodes unplugged To do this first remove the power module from the device or pull the plug from the power point if the optional mains power unit is fitted Do not use dripping wet cloths to clean it Do not pour any liquids over the device and do not immerse it in any liquids e Clean the device and all its accessories such as the wall bracket with commercially available household cleaners e Usea slightly damp clean cloth Use ordinary wiping disinfectants to disinfect e g Gigasept FF 12 2 Servicing Regardless of device usage we recommend that visual inspection of the PRIM EDIC HeartSave 6 6S and the accessories be carried out by the user service technician at regular intervals at least once a year M ake sure that the housing cable SavePads and all the other accessories are undamaged 12 2 1 Servicing check list e Check the expiry date o Of the SavePads o of the power modules and if necessary replace the parts with genuine parts e Check whether the status display OK is showing you can switch on the device the device automatically carries out the self test after being switched on the slot for the power supply 15 clean the device is fully equipped labelling is attached and legible O O O O 0 51 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC 52 Cleaning maintenance and dispatch
57. nd enter your PIN again Select the menu parameter lt Change PIN gt and confirm your new PIN with the key On the right next to the cursor the entry lt OK gt should appear This means your new PIN is active W hen the device Is first delivered the PIN is always set in the factory to 0000 Calling up activating a profile M ultiple menu parameters can be summarised into one profile Saved profiles can be called up as follows Q 9 Use the key 4 to change into the setup menu Select your required profile using the keys A W and confirm it with the key 4 The selected profile is active Please note that your profile selection is only active until the device is switched off The devices always starts with the profile Basic 35 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Using the device 7 3 4 Saving menu parameters in a single profile M ultiple menu parameters can be saved as one profile The profiles Basic Profile 1 Profile 2 and Profile 3 are available If you want to save parameters in a profile or want to change a profile proceed as follows Use the key 1 to change into the setup menu Change the required parameters from the various pages of the menu to suit your needs Change to page 6 of the menu Use the key A to navigate to the entry lt Profile selection gt and confirm your selection with the key H Use the keys A to select the required profile which is to be used to save th
58. nd starts on the day of purchase Please keep the invoice as proof of purchase The general guarantee and warranty provisions of METRAX GmbH are applicable Any repairs or changes to the device may only be carried out by the manufacturer or by a person or company authorised by the manufacturer Instructions HeartSave 6 6S 21230 GB F02 Introduction 1 4 Disclaimers Liability claims in the event of damages to people or property are excluded if they are based on one or more of the following reasons e Using the device in a manner for which it was not intended e Improper use and maintenance of the device e Operating the device with the protective covers removed or when there is obvious damage to cables and or electrodes e Non compliance with the instructions in these operating instructions with regard to operation maintenance and repair of the equipment e Using accessories and spare parts made by other manufacturers e Autonomous intervention repairs or constructional changes to the device e Autonomous overrunning of the performance limits e Lack of monitoring parts that are subject to wear and tear e Treatment of patients without prior indication 1 5 Symbols used in these operating instructions DANGER Texts marked DANGER indicate an extraordinarily serious current danger which will definitely lead to serious injury or even death if no preventative measures are adopted It is imperative that you pay at
59. ne Pressing any button or any other activity will interrupt the switching off process W hen the electrodes are not connected a dotted line appears on the monitor in the basic state with the instruction lt Check electrodes gt As soon as a derivation via the electrodes occurs the ECG signal appears on the monitor 9 4 Defibrillation not required If the device can not find a shockable rhythm it recommends cardio pulmonary resuscitation CPR lt No shock advised gt lt Cardiopulmonary resuscitation gt lt 30 x cardiac massage gt lt 2x artificial respiration gt Once the CPR time has expired the device returns to ECG analysis 45 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC 46 Operation in M anual M ode 9 5 10 Keeping the defibrillator ready for use e Atthe end of a reanimation clean the device replace the SavePads and check or if necessary replace the power supply unit so that the device is ready to use again as soon as possible Charge the battery pack so that sufficient power Is available the next time the device Is used e If any malfunctions or noticeable problems occur contact your nearest service facility as soon as possible Operation in M anual M ode Once it is switched on and after successful completion of the self test the device is in Auto M ode To activate manual mode press the key once The monitor shows the 1st page of the setup menu The M an M ode
60. on electrodes SavePads WY Fig 18 Position the electrodes on the patient 1 First electrode position RA 2 Second electrode position LL The positions of the defibrillation electrodes are e On the right side of the chest below the collar bone 1 e On the left side of the chest above the apex of the heart on the axillary line 2 Positioning the electrodes incorrectly may result in misinterpretations by the device 39 GB HeartSave 6 6S 21230 GB F02 ae PRIMEDIC Sees Eam gurkera 40 Positioning the electrodes 8 3 Checking the skin Before positioning the electrodes make sure that the patient s skin is dry Remove any medicated plasters at the electrode positions before applying the electrodes You must also make sure that the patient does not have any hair at the electrode positions If necessary remove any hair at the affected electrode positions with the enclosed razor 8 4 Positioning the ECG adhesive electrodes Fig 19 Position the electrodes on the patient 1 First electrode position R 2 Second electrode position F 3 Third electrode position L The positions of the ECG adhesive electrodes are e 1 Red R Directly below the centre of the right hand collar bone medioclavicular e 2 Green F Directly below the left chest muscle on the medioclavicular line e 3 Yellow L Directly below the centre of the left hand collar bone medioclavicular Positioning the el
61. orrect attachment site e g site with a venous pulse e Use of the pulse oximeter in the vicinity of strong energy sources such as M RI e Sensor attached too tightly e Arterial occlusion e Congestion caused e g by arterial catheter or blood pressure cuff Some of these variables may clearly recognised e g nail varnish and can be remedied or a reproducible result can be obtained at another measurement site However other variables e g contrast agents or problems in the blood serum cannot easily be identified Given the large number of influencing variables the S90 measurement must not be used as the sole means of monitoring vital signs Other parameters must also be monitored e g ECG blood pressure breathing W hen used correctly and with reference to the sensor specific warnings and instructions and clinical symptoms 500 measurement can be an important tool in evaluating patients GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Guidelines and manufacturer s declaration Electromagnetic emissions 18 Guidelines and manufacturer s declaration Electromagnetic emissions for PRIM EDIC HeartSave 6 65 referred to below as PRIM EDIC HeartSave The PRIM EDIC HeartSave is designed for use in an environment as described below The customer or user of the PRIM EDIC HeartSave should ensure that it is used in an environment of this kind Emitted interference measurements Conformance Electromagnetic
62. own several times to the menu item lt To page 2 gt o 00 Press the key to go to Page 5 M ove the cursor by pressing the key A to the menu item Time Select the highlighted menu item Time by pressing the key The hour is then highlighted Change the hour by pressing the A or W key Confirm the correct value with the key The minute is now highlighted Then change this as described under 3 and then press the key 4 To exit the setup menu move the marking with the key W to the menu item End Setup and confirm this with the key H If no key is pressed for one minute the device automatically leaves the setup menu and goes back to standby Instructions HeartSave 6 6S 21230 GB F02 Using the device 7 3 2 Changing the PIN Note 7 3 3 Note The PIN is used to save profiles Entering a PIN is absolutely necessary If you want to change the PIN you will always need to know the old PIN proceed as follows O 000 O 000 Use the key 2 to change into the setup menu Change to page 6 of the menu Navigate with the key A to the entry lt PIN gt and confirm your selection with the key H Enter the current PIN as follows Using the keys A W you can increase or decrease a digit With the key 1 you can change to the next digit After the fourth digit it jumps back to the menu item Navigate to the entry lt New PIN gt and enter your new PIN as described above Navigate to the entry lt Repeat PIN gt a
63. performance values For evaluation the test and reference annotations of segments with a length of 12 seconds were compared to each other Segments containing a shift between shockable and non shockable rhythms were not taken into account Performance results weighted average Instructions HeartSave 6 6S 21230 GB F02 Rhythm detection system Sensitivity 97 68 Requirement of IEC 60601 2 4 2003 gt 90 Specificity 99 99 Requirement of IEC 60601 2 4 2003 gt 95 False positive rate rate 0 01 Real predictive value 98 59 The databases used have a total length of about 10 000 minutes The calculation was made in accordance with IEC60601 2 4 2003 Sensitivity Number of correct shockable algorithm decisions Total number of ECGs in which administering an impulse is clinically recommended Specificity Number of correct not shockable algorithm decisions Total number of ECGs where shock administration 15 not clinically recommended False positive rate Number of incorrect shockable algorithm decisions Total number of ECGs where shock administration 15 not clinically recommended Positive predictive value Number of correct shockable algorithm decisions Total number of ECGs in which administering an impulse is recommended by the device GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC General advice for using pulse oximeters 17 General advice for using pulse oximeters W hat is pulse oximetry A
64. play The ECG Alarm can be deactivated in the Setup menu When the ECG Alarm is deactivated the bell symbol is permanently crossed out If in this case the alarm limits are exceeded no acoustic alarm is initiated but the bell symbol and heart rate flash in order to inform the user Note If the unit is operated with PRIM EDIC SavePads electrodes a bell symbol appears in auto mode for the ECG alarm and 15 always crossed out to indicate that no ECG alarm 15 made in this mode By this means interfering messages are avoided during the repetition of the HLW request VF Alarm The VF Alarm only occurs during ECG monitoring with ECG electrodes ECG cable by means of which shocks cannot be applied With the VF Alarm eight gong type muffled tones are heard over a period of approx 5 seconds which are repeated every 20 seconds and accompanied by the verbal message lt Analysis recommended use SavePads gt If the ECG Alarm 15 activated the acoustic Alarm takes place with the ECG Alarm tone The speech output Is always provided The VF alarm requests replacing the ECG cable and the ECG electrodes for the PRIM EDIC SavePads because otherwise defibrillation cannot take place Warning Defibrillation cannot take place via an ECG monitoring cable If during ECG monitoring shock requiring rhythms e g VF arise we need to use the SavePads 37 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Using the device 7 4 3 SP
65. posed to use or want to use it e must be instructed in a training session about the medical background of defibrillation and the indications or contraindications and thus need to be authorised need to read and take note of these operating instructions and in particular the safety tips and warning advice detailed in them The PRIMEDIC HeartSave 6 6S may only be used by trained and authorised personnel Reading the operating instructions does not replace training The PRIMEDIC HeartSave 6 6S is not licensed for use in explosive areas DANGER Not using the device as intended or using it improperly exposes the user the patient or third parties to the danger of an electric shock from the high voltage generated by the device of influencing active implants of burns from incorrectly applied electrodes Apart from that the device can be damaged or destroyed through improper use Refer to the advice and rules in the appendix when using the PRIM EDIC HeartSave 6 6S Instructions HeartSave 6 6S 21230 GB F02 Safety advice Applicable for Europe The device complies with the M edical Device Directive M DD For Germany the following also applies The device complies with the M edical Devices Law M PG and 15 subject to the Ordinance on the Operation and Use of M edical Devices M PBetreibV According to the Ordinance on the O peration and Use of M edical Devices M PBetreibV the device must be sub
66. power Is available the next time the device is used If any malfunctions or noticeable problems occur contact your nearest service facility as soon as possible Attaching the SpO sensor Fig 23 Attaching the SpO sensor 1 Anti kink sleeve 2 SpO sensor 3 Clip surface Press the two clip surfaces 3 together and slip the open sensor onto any finger so that the cable socket end of the sensor 15 on the same side of the finger as the finger nail The sensor may be allowed to remain for a maximum of four hours on the same measurement site provided that the condition of the skin and correct positioning of the sensor are regularly checked Since skin tolerance at the measurement site varies according to different skin types you may need to switch the measurement site more often for some patients 49 GB HeartSave 6 6S 21230 GB F02 ve PRIMEDIC Lin Geerguranea 50 Attaching the 5000 2 sensor 11 1 Connecting the 500 2 sensor Procedure Insert the plug 1 on the SPO sensor in the unit plug socket so that the arrow 3 on the plug lines up with the arrow 4 on the socket M ake sure that the plug is fully inserted To disconnect the plug connection first raise the sleeve with the arrow 2 slightly and then pull the plug connector from the socket Fig 24 Inserting SpO plug Instructions HeartSave 6 6S 21230 GB F02 WJ M Cleaning maintenance and dispatch 12 Cleaning maintenance a
67. r Completely remove the SaveCard from the device and transfer the data if applicable onto a PC and insert this card or a new one in the device with the pin end first Gently press the card in until the button 1 projects slightly out of the device Finally insert the power module into the device again 6 3 Inserting replacing the energy module The PRIM EDIC HeartSave 6 65 can be operated with three different power modules e Rechargeable battery pack AkuPak e Non rechargeable LiM nO battery optional e PowerLine optional Before using the device for the first time you must insert the power module in the specially designed slot 23 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Saurs Lilie Georgerlanca Preparatory measures before initial start up Check the power supply every time after you have used the device If necessary replace the battery or recharge the battery pack If this is not possible a second charged battery pack must be available to ensure that the device is ready for use 6 3 1 Inserting the power module Fig 13 PRIMEDIC HeartSave 6 6S inserting the power module 1 Power module slot 2 Power module 3 Limit stop 4 Release button 5 Power module tongue The HeartSave is always supplied with a power module All three different types of power module are inserted the same way Procedure Lay the device on its back Push the power module 2 in
68. r defibrillation is necessary The family of devices is set up on a modular basis types of models HeartSave 6 basic model with monitor and 6 channel ECG HeartSave 6S basic model with monitor and 6 channel ECG and pulse oximetry The PRIM EDIC HeartSave generation has been designed for rapid and safe use in emergency situations All functional units and operating elements are subject to the following principles e Clear organisation of functional units e Reduction of functions to those necessary e Intuitive and logical operator guidance e Clear self explanatory operating elements e Ergonomic layout The ECG monitor has a high resolution graphical display that delivers high image contrast even under difficult light conditions The defibrillator unit has been optimised to be safe and quickly ready to use The loading time for a defibrillation is max 12 seconds with a battery capacity of approx 90 of the rated value Power is supplied to the PRIM EDIC HeartSave 6 65 either by single use lithium batteries or by rechargeable removable batteries with nickel cadmium cells or via a mains power unit depending on the particular model The wall bracket and accessories are described in separate operating instructions Instructions HeartSave 6 6S 21230 GB F02 Description of device 4 2 Description of device details Fig 1 PRIMEDIC HeartSave 6 6S front view 1 Carry handle 2 Flap for removing the device co
69. racy 20 500 2500 Ohm 30 kHz ECG SpO defibrillator power supply schockable rhythm Approx 7 secs until VF is recognised High resolution LCD monitor Instructions HeartSave 6 6S 21230 GB F02 Technical Data M onitor size Resolution Displays Power supply Removable battery battery pack PowerLine Battery Data storage Memory type Safety Classification Identification Other Operating conditions Storage conditions Dimensions W eight Standards applied GB HeartSave 6 6S 21230 GB F02 95 x 72 mm diagonal 120 mm 4 7 320 x 240 pixels pixel size 0 36 x 0 36 mm Heart frequency number of defibrillations number of recognised VF reanimation time date time rechargeable battery capacity ECG NiCd 12 V 1 4 Ah service life 2 5 years 100 240 volts 50 60 Hz LIM nO 15V 2 8 Ah 0 to 20 C service life is 6 years at 20 C Compact FlashCard 32M B 2 GB Device with internal power supply battery pack and battery medical product from Class 110 protection class type CF defibrillation proof C 0123 The device is a medical product and complies with the EC Directive 93 42 EEC 0 55 C 30 95 rel humidity but without condensation 700 hPa 1060 hPa continuous mode 20 70 C 20 95 rel humidity but without condensation 500 hPa 1060 hPa continuous mode 28x25x9cm W XH xD Approx 2 0 kg without
70. rovide much more defibrillation or has longer standby time than for example a comparable lead battery Handling of the NiCd rechargeable battery 15 virtually 100 problem free Thanks to modern microprocessor controlled charging connections as used in the PRIMEDIC battery pack the battery charging times required are very short and the battery is protected during the charging process If the NiCd rechargeable battery 15 only partially discharged and recharged over an extensive period a memory effect typically occurs In practice this memory effect means that the rechargeable battery behaves as if it were a small rechargeable battery with low capacity despite its nominally large battery capacity For example A rechargeable battery has a capacity of 50 defibrillations for example The power for 5 defibrillations is used and the battery is then recharged The memory effect may set in if this mode of operation is continued over a long period As a result the battery Capacity is reduced to 5 or 6 defibrillations since the rechargeable battery has been trained to expect 5 defibrillations It is extremely difficult to reverse the memory effect The rechargeable battery cannot therefore be used properly once its residual capacity falls below a viable value Avoiding the Memory effect To avoid the memory effect the battery must be fully discharged from time to time so that it is possible to intermittently carry out a complete
71. s M PBetreibV 6 Safety checks the operator is obliged to have regular checks carried out In accordance with the German M edical Products User Regulations M PBetreibV 6 M ETRAX stipulate these checks be carried out in a 24 month cycle The safety checks may only be assigned to people who because of their training their knowledge and their experience gained through practical activity can carry the checks out properly and do not need instruction to do so If during the safety check faulty are found which could be hazardous to patients employees or third parties then the operator must immediately inform the responsible authorities in accordance with German M edical Products User Regulations M PBetreibV 3 In the medical products log to be kept in accordance with the German M edical Products User Regulations M PBetreibV 7 the following data Is to entered e Time of carrying out the work e Name of person or company carrying out the work and e Measures taken The responsibility of M ETRAX only covers the information provided in the operating instructions This applies in particular for readjustments repairs and changes to the device Instructions HeartSave 6 6S 21230 GB F02 Using the equipment on ships 21 Using the equipment on ships 21 1 Use of PRIMEDIC HeartSave units together with a PRIMEDIC battery on ships in the merchant navy The use of the following PRIMEDIC HeartSave M250
72. sistance application section Keep the defibrillation electrodes away from other electrodes and from metallic parts which are in contact with the patient e Do not use the device on children under the age of 8 or on children with an estimated body weight of less than 25 kg e Position the electrodes precisely according to the description e Dry the chest and carefully remove any large amount of hair on the patient before applying the defibrillation electrodes Instructions HeartSave 6 6S 21230 GB F02 Safety advice DANGER e Do not touch the patient during the ECG analysis and avoid any vibration e Do not place the defibrillation electrodes directly over an implanted pacemaker to avoid a possible misinterpretation by the device and to avoid any damage to the pacemaker from the defibrillation impulse e If the ECG analysis is being carried out in a vehicle the vehicle has to stop and switch off the engine to guarantee correct analysis e Interrupt the reanimation as long as the PRIMEDIC HeartSave 6 6S is analysing the ECG e Do not touch the patient during defibrillation Avoid any contact between parts of the patient s body such as bare skin on head or legs and conductive liquids such as gels blood or salt solutions and metallic objects around the patient such as bed frame or bedside stretching aid that create unintended paths for the defibrillation current 3 5 Safety advice for the protection
73. ssories 5 1 SavePads Fig 8 PRIMEDIC SavePads in unpacked condition 1 Electrode plug 2 Defibrillation electrodes with protective film 5 2 Two pin patient cable for ECG recording optional accessory Fig 9 Two pin patient cable for ECG recording optional accessory 1 2 pin electrode cable with plug 2 Electrode clips red green 3 ECG electrodes Ag AgCl ae Instructions HeartSave 6 6S 21230 GB F02 Description of the accessories 5 3 Three pin patient cable for ECG recording Fig 10 Three pin patient cable for ECG recording 1 3 pin electrode cable with plug 2 Electrode clips red yellow green 3 ECG electrodes Ag AgCl 5 4 SpO sensor only on HeartSave 6S Fig 11 SpO sensor with adapter cable 1 Cable for 500 sensor 2 SpO sensor 3 Plug for connection to the adapter cable 4 Socket with locking device 5 Plug for connection to the HeartSave 6 Adapter cable Additional accessories can be found on our home page www primedic com under Online Shop 21 GB HeartSave 6 6S 21230 GB F02 ae PRIMEDIC Soest Lids Exoryurlanen 22 Preparatory measures before initial start up 6 Preparatory measures before initial start up 6 1 Unpacking e After delivery first of all check the packaging and the device for transport damage e f you notice any damage to the device immediately contact your transport company dealer or directly contact technical ser
74. tation CPR 2005 The PRIM EDIC HeartSave may only be used as described and under the conditions detailed in these operating instructions 2 1 Indications The PRIM EDIC HeartSave 6 6S may only be used for defibrillation if the patient e iS unconscious and e no normal breathing can be ascertained and e after talking to the patient no other signs of life can be perceived 2 2 Contraindications The PRIM EDIC HeartSave 6 65 must not be used for defibrillation if the patient e is conscious or e breathing or e shows other signs of life e isa child under the age of 8 or weighs less than 25 kg respectively Treatment should not be delayed to ascertain the precise age or weight of the patient GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Safety advice 3 Safety advice 3 1 General advice The PRIMEDIC HeartSave 6 65 fulfils the currently applicable safety standards and complies with the provisions of the medical products guidelines both as a stand alone device and in conjunction with its fittings and optional accessories The device and its accessories are safe when used as intended and when following the descriptions and information detailed in these operating instructions Nevertheless if used incorrectly the device and its accessories can be dangerous for the patient or third parties DANGER We emphatically advise that before using the device for the first time all those who are sup
75. tem includes 6 Ascertaining the electrode contact Automatic evaluation of the ECG O perator control of the output of defibrillation shocks Ascertaining the electrode contact The transthoracic impedance of the patient is measured by the defibrillation electrodes If the baseline impedance is greater that the maximum critical value then the device determines whether the electrodes are not in good enough contact with the patient or if they are not connected properly to the device ECG analysis and dispensation of defibrillation shocks are therefore prevented The voice output says Check electrodes if the contact of the electrodes is insufficient Automatic evaluation of the ECG The device s rhythm detection system has been designed so that a defibrillation shock is recommended if the system has been connected up to a patient who is unconscious not breathing and has no pulse and the system ascertains a shockable rhythm W ith all other ECG rhythms including asystolia and normal sinus rhythms the rhythm detection system in the device does not recommend defibrillation Operator control of the output of defibrillation shocks The rhythm detection system of the device initiates automatic device charging if it detects a shockable heart rhythm O ptical and acoustic messages are emitted to show you that the device recommends giving a defibrillation shock If a defibrillation shock is recommended you decide whether and when the shock is to
76. tention to these texts Texts marked WARNING indicate an extraordinarily serious potential danger which could lead to serious injury or even death if no preventative measures are adopted It is imperative that you pay attention to these texts Texts marked with CAUTION indicate a possibly dangerous situation which could lead to minor injuries or damage to property It is imperative that you pay attention to these texts This symbol indicates text which contains important advice comments or Note tips 0 This point identifies the description of tasks that you need to perform GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC Introduction This point identifies a list Numbers in brackets refer to items in diagrams Texts set in pointed brackets denote acoustic advice instructions by the device which are also shown simultaneously on the monitor only on HS6 1 6 Pictograms on the device 1055 1053 IP33 A Protection against contact and dust deposits on the inside Protection against jets of water nozzle from any angle only in combination with a battery IP53 in connection with a battery pack 1033 10 connection with PowerLine Please observe the operating instructions Do not dispose of device in domestic refuse Dangerous electric voltage high voltage CF defibrillation proof degree of protection in connection with ECG patient cable Type certification GERM ANIS
77. ts W according to the manufacturer of the transmitter NOTE1 At 80 MHz and 800 M Hz the higher frequency range is applicable NOTE2 The ISM frequency ranges for industrial scientific and medical applications between 150 kHz and 80 M Hz are 6 765 M Hz to 6 795 M Hz 13 553 M Hz to 13 567 M Hz 26 957 M Hz to 27 283 M Hz and 40 66M Hz to 40 70 M HZ NOTE3 The purpose of the concordance levels in the ISM frequency bands between 150 kHz and 80 MHz and 2 5 GHz is to reduce the probability of mobile portable communication devices causing interruptions if they are unintentionally brought into the vicinity of the patient For this reason the additional factor of 10 3 is applied when calculating the recommended safety distance in these frequency ranges NOTE4 These guidelines may not be applicable in all cases The spread of electromagnetic factors is affected by absorption and reflections from buildings objects and people 69 GB HeartSave 6 6S 21230 GB F02 ma PRIMEDIC 70 General instructions and rules for using the optional AkuPak 19 General instructions and rules for using the optional AkuPak A nickel cadmium rechargeable battery NiCd rechargeable battery was selected to operate the PRIM EDIC HeartSave 6 65 as this type of rechargeable battery offers some practical advantages over other rechargeable batteries The NiCd battery has a high power density i e with the same physical size the PRIM EDIC battery can p
78. units PRIMEDIC HeartSave PAD AED AED M HS6 HS6 S with the energy supply module PRIMEDIC Battery 15VDC 2 8Ah LiMnO4 fulfils the EM C requirements of Zone for the bridge and the open deck asper the Guidelines for the Performance of Type Approvals or Test Requirements for Electrical Electronic Equipment and Systems of the Rules for Classification and Construction Book VI Additional Rules and Guidelines of Germanischer Lloyd 2003 21 2 Use of PRIMEDIC HeartSave units together with a PRIMEDIC AkuPak on ships in the merchant navy PRIM EDIC HeartSave units with a PRIM EDIC battery have been EM C checked for compliance with Test Requirements for Electrical Electronic Equipment and Systems of Germanischer Lloyd 2003 Because the PRIMEDIC AkuPak 12VDC 1 2Ah NiCd whilst supplying the PRIM EDIC HeartSave M 250 units behave as the PRIM EDIC battery we can transpose the experience gained from all EM C test results to the combinations of the PRIM EDIC AkuPak with all PRIM EDIC HeartSave M 250 units These combinations fulfil during supply mode the requirements of Zone for the bridge and the open deck Recharging the PRIM EDIC AkuPak requires a PRIM EDIC ClipCharger as the chargerunit Recharging must be carried out in a dry room which is isolated by metallic screening from Zone for the bridge and the open deck The equipment combination always ful
79. vV PRIMEDIC Www primedic com Saves Life Everywhere jF HeartSave 6 6S M asthead Publisher 21230 GB F02 METRAX GmbH Rheinwaldstr 22 D 78628 Rottweil Germany Tel 49 0 741 257 0 Fax 49 0 741 257 235 info primedic com WWww primedic com by METRAX GmbH These operating instructions may not be reproduced transferred electronically saved or translated into a human or computer language in whole or in part without our permission Violations of this prohibition not only infringe our copyright but also reduce our possibilities to provide the users and operators of the device with precise and punctual information We reserve the right to make amendments to these operating instructions Printed in Germany Table of contents Table of contents 1 Introduction 2 Me FONO a E A E A E ane case adnate teeedseanddans sani 2 L2 Va eee E a E E 2 O e E 2 A ADS CIAO S sacs tetece esata ENEE ETE A EE E ER 3 1 5 Symbols used in these operating instructions ssssssssrrseeesssrrrrreeesrrrrrrreeersrrrreeesrrrrn 3 1 6 Pictograms ON the 06 166 2 1 4 1 7 Pictograms ON SavePadS 1
80. ver 3 Device cover Fig 2 PRIMEDIC HeartSave 6 6S rear view 1 M ounting slot for wall bracket 2 Name plate 13 GB HeartSave 6 6S 21230 GB 02 LA PRIMEDIC 14 Description of device Fig 3 PRIMEDIC HeartSave 6 6S bottom view 1 Release button for removing the power module 2 Power module Be PRIMEDIC HeartSave a Fig 4 PRIMEDIC HeartSave 6 6S control elements On Off button M embrane keyboard with monitor Key for scrolling upwards in the menu or for increasing parameters Select Confirm key Enter key Key for scrolling downwards in the menu or for reducing parameters Loudspeaker Socket for electrode cable Energy loading button charging button in manual mode Socket for 500 sensor on HeartSave 6S 10 Shock button WO oO N OU BW N e Instructions HeartSave 6 6S 21230 GB F02 Description of device 00 03 46 mp 1079 1077 10 02 x Fig 5 Monitor representation 1 2 3 4 5 6 Display of switch on duration time sequence HLW cycle M ode MAN asynchronous Sync synchronous VF Auto AED EKG channel line Indicator heart rate and alarm limits Indicator Pulsoximeter and alarm limits Status line to show CF card capacity patient impedance time of day microphone battery capacity 7 Indicator ECG channels max 2 8 9 Energy stages only in manual mode SpO curve only HeartSave 6S instructions information only HeartSave 6 tadh manual
81. vices at METRAX GmbH stating the device number and describing the damage to the device Definitely do not use the device if you know of any damage Endangering health cannot be ruled out e Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery note 6 2 Inserting Replacing the SaveCard Fig 12 PRIMEDIC HeartSave 6 6S SaveCard 1 SaveCard removal button 2 Slot with SaveCard inserted Instructions HeartSave 6 6S 21230 GB F02 Preparatory measures before initial start up 6 2 1 Note 6 2 2 Inserting the SaveCard Procedure Before sw itching the device on for the first time insert the SaveCard into the specially designed slot 2 Gently press the SaveCard in until the button 1 projects slightly out of the device Now insert the power module into the device oo The device then starts up and carries out a self test The data saved on the SaveCard should be archived externally after every deployment if possible Once the storage capacity of the SaveCard Is exhausted no further data will be saved The device remains ready for Operation even if the memory is exhausted and even without a SaveCard Replacing the SaveCard Procedure Before you can remove or replace the SaveCard you must first remove the power module For more details see chapter 6 3 Press the button 1 in fully this pushes the SaveCard 2 slightly out of its holde

Operating Instructions

Contents

Download Pdf Manuals

Related Search

Related Contents