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Page 51

Technical Data

User Guide

Classification and safety standards

7.2

rt.

no.

: 0-4

8-02

40 Rev. c

DefiSign Life AED

7.2 Classification and safety standards

Standards

DefiSign Life AED

complies with IEC standard 60601-2-4.

According to IEC standard 60601-2-4,

DefiSign Life AED

is a device for infrequent

use.

EMC

See

7 Technical Data

Compliance

•

DefiSign Life AED

bears the (Notified Body LNE/G-MED) mark

indicating its compliance with the provisions of the Directive 93/42/EEC (modified
by the Direc-tive 2007/47/EEC) regarding medical devices and fulfils the
essential require-ments of Annex I of this directive.

•

DefiSign Life AED

is a class IIb device.

Patient Protection

BF type, resistant to defibrillation shocks.

Explosions protection

DefiSign Life AED

not

designed to be used in the presence of flammable

mixtures of anaesthetic agents with air or oxygen.

The SCHILLER quality management system complies in full with the international
standards ISO 9001 and ISO 13485.

Summary of Contents for DefiSign Life

Page 1: ...Art no 0 48 0240 Rev c 0 48 0240 DefiSign Life AED User Guide Automated external defibrillator AED made by Schiller ...

Page 2: ... rue Louis Pasteur Fax 33 0 388 94 12 82 F 67162 Wissembourg E mail quality schiller fr Web www schiller medical com Address Headquarters SCHILLER AG Phone 41 0 41 766 42 42 Altgasse 68 Fax 41 0 41 761 08 80 CH 6341 Baar Switzerland E mail sales schiller ch Web www schiller ch Article no 0 48 0240 Rev c Issue date 23 03 17 Corresponds to original Software 03 ...

Page 3: ...mbols used on the device 9 1 11 3 Symbols used on the battery 10 1 11 4 Symbols used on the electrode packaging 11 2 Components and Operation 12 2 1 General Information 12 2 2 Design 13 2 2 1 Overview of the configurable settings 14 2 3 Operating and Display Elements 15 2 3 1 Overview DefiSign Life AED 15 2 3 2 Display and Operating Elements 16 2 4 Function 17 3 Initial operation 18 3 1 Inserting ...

Page 4: ...y 35 4 7 Removing the battery 35 5 Communication 36 5 1 Retrieving intervention data 36 6 Maintenance 37 6 1 Maintenance Intervals 37 6 1 1 Exemption from the technical safety inspection 38 6 1 2 Service Shelf life 38 6 1 3 Visual inspection of the device and accessories 39 6 1 4 Mains status LED 40 6 1 5 Functional check 40 6 1 6 Internal backup battery 40 6 2 Cleaning and disinfection 41 6 3 Acc...

Page 5: ... Classification and safety standards 48 7 3 Defibrillation pulse 49 7 3 1 Shock Advisory System 51 7 4 Electromagnetic interferences 52 7 4 1 Electromagnetic emissions 52 7 4 2 Electromagnetic immunity 52 7 4 3 Recommended minimum distances 54 7 5 Literature 55 7 6 Glossary 55 7 7 Inspection report 56 8 Index 58 ...

Page 6: ...Page 6 DefiSign Life AED Art no 0 48 0240 Rev c ...

Page 7: ...gested by the device must be examined with respect to the pa tient s overall clinical condition and the quality of the recorded data Damaged or missing components must be replaced immediately The device must be stored in a place inaccessible to children Properly dispose of the packaging material and make sure it is out of children s reach The DefiSign Life AED is an emergency device and must be re...

Page 8: ...r of electric shock Danger for user rescuer and patient The energy applied to the patient can be conducted through the patient to other persons who may suffer a lethal electric shock Therefore do not touch the patient the electrodes or other conducting objects during defi brillation do not defibrillate the patient in a puddle of water or on other conducting surfac es switch the device off when it ...

Page 9: ...evices before their further use 1 8 Maintenance and Cleaning Danger of electric shock Do not open the device No serviceable parts inside Refer servicing to qualified personnel only Before cleaning switch the unit off and remove the battery Do not use high temperature sterilisation processes such as autoclaving Do not use E beam or gamma radiation sterilisation Do not use aggressive or abrasive cle...

Page 10: ...uent damage is exclud ed The warranty is void if unauthorised or unqualified persons attempt to make re pairs In case of a defect send the device to your dealer or directly to the manufacturer The manufacturer can only be held responsible for the safety reliability and performance of the apparatus and assume the warranty if assembly operations extensions readjustments modifications or repairs are ...

Page 11: ...vere personal injury or death For a possibly dangerous situation which could lead to severe personal injury or to death For a possibly dangerous situation which could lead to personal injury This symbol is also used to indicate possible damage to property For general safety notes as listed in this section For electrical hazards warnings or precautionary measures when dealing with elec tricity Impo...

Page 12: ...tery The battery is recyclable Do not recharge Do not short circuit Do not incinerate Do not cut Do not crush Normal storage temperature duration and allowed out of range temperature dura tion see chapter 7 Technical Data Battery must not be disposed of in the household waste Observe the user guide Battery expiry date ...

Page 13: ...tective foil Disposable item do not reuse Do not bend packing Storage temperature for the electrodes Expiry date of the electrodes An open package cannot be conserved more than one day Do not expose to sunlight Does not contain latex Do not expose to rain Consult the user guide Manufacturer symbol manufacturing date CE 0408 marking notified body For use by or on the order of a physician or person ...

Page 14: ...AED vary from country to country While some countries allow laypersons to use AEDs without any special training oth er countries restrict the use of AEDs to an Emergency Medical Technician or First Re sponders after they have undergone special training Highly frequented areas are typical places for the operation of a DefiSign Life AED Some examples below airports train stations shopping centres pu...

Page 15: ...the shelf life of the electrodes when connected to the device The device can be provided with different languages Optional configuration with 3 languages selectable after switching the device on The DefiSign Life AED sets a configurable pace for the cardiopulmonary resuscitation CPR Information on the chest compression frequency using impedance variation acquired with defibrillation pads The devic...

Page 16: ... Selection of the default language at device start Energy level for 1st 2nd and 3rd shock separate settings for adults and children Number of chest compressions for children 15 or 30 Self test frequency daily or weekly Choice between continuous chest compressions or alternating chest compres sions breaths during CPR cycles Date and time Update of the software change of the device language Selectio...

Page 17: ... The device is switched on when the cover is opened Compartment for additional electrode Page 17 Components and Operation 2 User Guide Operating and Display Elements 2 3 Art no 0 48 0240 Rev c DefiSign Life AED 2 3 Operating and Display Elements 2 3 1 Overview DefiSign Life AED ...

Page 18: ...tic advices With the Repeat Key the last message is repeated Repeat the last message Emergency number The emergency number can be customised with the provided stickers Electrode connector Multiple language device As soon as the cover of the device is opened the device starts issuing acoustic ad vices in the default language The two other languages can be selected at any time during the resuscitati...

Page 19: ...ice has not detected an error If a problem is detected during this test an acoustic alarm is issued the status LED stops blinking additional information are given by the service LEDs Fig 2 1 LED indicator If an alarm is in progress visual and or acoustic the battery autonomy is reduced In addition the device performs a daily or weekly self test this setting must only be configured by service perso...

Page 20: ...h household waste Do not expose the battery to chemicals that could dissolve ABS polypropylene polyvinyl chloride nickel mylar or steel Do not short circuit cut destroy burn or charge Li MnO2 battery a battery Patient hazard Incorrect battery capacity indication A new battery is initialised at first insertion Replace the battery if the device indicates a battery problem A defective battery must no...

Page 21: ... soon as the battery is inserted the DefiSign Life AED runs a self test to check the condition of the device and the battery During the test the modem LED is on and the electrodes LED is blinking This test can last for more than 1 minute If this test does not reveal any problems the green indicator is blinking and all service status LEDs are off showing that the device has not detected an error Fi...

Page 22: ...steps are briefly lit Switching OFF Close the cover Forced shutdown procedure If the device cannot be switched off via the above procedure remove the battery and insert it again If a patient is detected while closing the cover the device will remain ON and the resuscitation process will go on If the cover is re opened within 30 seconds after closing the device will resume the intervention ...

Page 23: ...atus LED green on the DefiSign Life AED is blinking when the battery capacity is sufficient to perform the resuscitation protocol 3 2 2 Low battery capacity indication Low battery capacity indication is the same during self test after the battery has been inserted and during use Despite the low battery indication the device can still be used as normal and is still able to perform defibrillations A...

Page 24: ...be replaced immediately If a depleted battery is detected while the device is in use the device will prompt the user to replace the battery and perform CPR An audible signal is emitted The main status LED is off and the orange battery LED is blinking until the battery is replaced Battery LED Depleted battery during self test An audible signal is emitted the main status LED 1 is off and the battery...

Page 25: ...ntact Do not reuse the pads 3 3 1 Connect the electrodes 1 Remove the battery 2 Remove the sticker with the LOT Expiration date from the electrode pouch and stick it above the main status LED 3 Open the cover 4 Connect the electrode cable to the device 5 Put the electrode pack in the cover and close the cover 6 Make sure that neither the electrode cable nor the electrode packaging are squeezed by ...

Page 26: ... posterior placement is advised to prevent a short circuit between the two defibrillation electrodes A defibrillation can fail with certain disease patterns Patients with implanted pacemakers DefiSign Life AED features an electronic pac er pulse suppression algorithm and therefore pacemaker pulses are not taken into account during the analysis Depending on the pacemaker model and on the posi tion ...

Page 27: ...n current For safety wipe off flammable skin cleansing agents The assistants tasks must be clearly defined as follows During ECG analysis suspend CPR ensure that the patient lies as motionless as possible do not touch the patient otherwise artefacts may lead to incorrect analysis re sults Immediately prior to the shock stop chest compressions and artificial respiration CPR Risk of skin burns for t...

Page 28: ...per body perform the following steps Open the electrode packaging and apply the electrodes to the patient s chest 1 Defibrillation pad to be placed at the right sternal edge at the level of the 2nd in tercostal space 2 Defibrillation pad to be placed at the left axillary line at the level of the 5th inter costal space 3 If not connected insert the electrode connector into the electrode port Fig 4 ...

Page 29: ...lectrode application sites for children weighing 25 kg or more Electrode placement is the same for adults and for children weighing 25 kg or more see Fig 4 4 Electrode application sites for children weighing 25 kg or more Before applying the adhesive electrodes verify that the application sites on the patient s chest are clean and dry 4 Carefully shave the application sites if the patient s chest ...

Page 30: ...dren weighing less than 25 kg Electrode placement on children weighing less than 25 kg see Fig 4 5 Application sites for children weighing less than 25 kg Before applying the adhesive electrodes verify that the application sites on the patient s chest are clean and dry When defibrillating children it is recommended to choose the anterior posterior posi tion to avoid short circuiting the electrodes...

Page 31: ...s chest and then recommends performing a CPR cycle resumes the intervention where it has been interrupted when it detects that the re sistance between both electrodes is acceptable again switches off if it still does not detect acceptable impedance between both elec trodes after 5 minutes Follow these steps to check the electrodes 1 Insert the connector as specified in 3 3 1 Connect the electrodes...

Page 32: ...dition not responsive no respiration no pulse 3 Apply the defibrillation electrodes to the patient s chest see 4 2 Applying the ad hesive electrodes Apply the electrodes is blinking as long as the electrodes are not properly applied to the patient s chest and or the electrode connector is not properly connected to the de vice Step 2 Analysing the ECG signal Fig 4 7 Analysing do not touch the pa ti...

Page 33: ...d with Step 4 Performing cardiopulmonary resus citation Step 4 Performing cardiopulmonary resuscitation If the FreeCPR option is activated the device instructs the rescuer to adjust the chest compression frequency FreeCPR measures the compression rate based on the impedance measurement by the defibrillation electrodes 6 Perform a CPR cycle According to the configuration of the device a CPR cycle c...

Page 34: ...arding the therapy steps If a shock is advised a countdown accompanies the last 3 seconds before the shock is delivered 4 4 2 Safety notes for automatic defibrillation Risks for patient users and assistants Once the device has been switched on by opening the cover and the electrodes have been applied the ECG analysis is started automatically and a shock is delivered au tomatically if a shockable r...

Page 35: ...pplying the ad hesive electrodes Apply the electrodes LED is blinking as long as the electrodes are not properly ap plied to the patient s chest and or the electrodes connector is not properly connected to the device Step 2 Automatic ECG analysis Fig 4 11 Analysing do not touch the pa tient 4 The analysis is automatically triggered without user intervention A message prompts the user not to touch ...

Page 36: ...oceed with Step 4 Performing cardiopulmonary resuscita tion Step 4 Performing cardiopulmonary resuscitation If the FreeCPR option is activated the device instructs the rescuer to adjust the chest compression frequency FreeCPR measures the compression rate based on the impedance measurement by the defibrillation electrodes 5 Perform a CPR cycle According to the configuration of the device a CPR cyc...

Page 37: ...rode cable Switch off the device once the therapy has been completed close the cover Carefully peel the pads off the patient s skin see Fig 4 12 Removing the adhesive pads Recycle the disposable pads immediately after use to keep them from being reused by mistake hospital waste Connect a new pre connected pad see 3 3 1 Connect the electrodes Retrieve the intervention data see 5 1 Retrieving interv...

Page 38: ... SD card must be con figured according to the following instructions 1 With a computer create a directory called from_device on the SD card 2 Remove the battery from the device 3 Insert the SD card in the slot 4 Insert the battery The device is switched on automatically 5 The modem LED 1 is on and the service LED 2 is blinking throughout the data transfer process which can last more than 5 minutes...

Page 39: ...place the electrodes After battery insertion check that the status LED is blinking and that the other LEDs are off see 6 1 4 Mains status LED Visual inspection of the device see 6 1 3 Visual inspection of the de vice and accessories User Once a Week Month Check that the green main status LED is blinking and all other LEDs are off see 6 1 4 Mains status LED Visual inspection of the device and acces...

Page 40: ...condensation Protection against dust Operation sites no mobile operation sites e g train car bus airplane not placed on walls with risk of vibrations e g near doors windows Exemption from the technical safety inspection of the DefiSign Life AED if all factors are fulfilled Yes No Location Date Carried out by 6 1 2 Service Shelf life Device The device has defined Service Life of 10 years if mainten...

Page 41: ...ages Device casing undamaged No excessive clogging or damage Legible nameplate at the rear of the device Legible inscriptions on the front face of the device Expiration date of the electrode elapsed see section 3 3 1 Connect the electrodes page 25 Expiration date of the battery elapsed Electrodes past their expiration date must be replaced immediately Electrode and Service LEDs are on only by usin...

Page 42: ... more operational the corresponding service LED is blinking see detail in chapter 6 5 1 Error messages 6 1 5 Functional check Patient hazard If the device s behaviour differs from the description given in this user guide or the main status LED is not blinking the device is defective and must be repaired In case of intensive use of the device SCHILLER recommends that these in spections be performed...

Page 43: ...has penetrated the device it must not be used until it has been checked by a service tech nician Equipment damage Do not clean the surface of the device with phenol based disinfectants or peroxide compounds Device casing Wipe the device with dampened cloth make sure no liquid enters the device All cleaning or disinfection products commonly used in hospitals and containing al cohol maximum 70 are a...

Page 44: ...SCHILLER products 6 3 1 Order Information Part No Description 1 127 9902 DefiSign Life AED semi automatic 1 127 9901 DefiSign Life AED fully automatic 1 127 3780 Multiple language option 1 127 5180 Wall bracket 1 127 3580 FreeCPR CPR feedback option Devices Part No Description 0 21 0040 1 pair of disposable adhesive defibrillation pads for adults 80cm pre connected with RFID 2 155067 1 pair of dis...

Page 45: ...ulations Apart from the internal and plug in batteries the device does not contain hazardous material and can be recycled like any other piece of electronic equipment In accordance with national law the battery must be dis posed of at an appropriate waste disposal station or returned to SCHILLER According to European legislation this device is considered as electronic waste equipment It can be ret...

Page 46: ...harge the HV capacitor and to de liver a defibrillation shock It only indicates to perform CPR Critical device state The device is out of order Description Device State Status LED Alarm sound Battery LED Electrode LED Service LED Remedy Power supply problem or cor rupted firmware ON Contact your sales representative Battery pack defect ON Replace the battery Main battery almost empty lower than 10...

Page 47: ... a duration of 48 hours are out of the limits the device will give a warning Electrode and Service LEDs will light sound alarm if configured the status LED continues to blink The frequency of the temperature verification during the 48 hours can be configured from 1h to 24h Alarm limits 50 C for the high limit and 5C for the low limit ...

Page 48: ...tery and insert it again Have the device repaired Incorrect analysis result e g the device does not detect a shockable rhythm even though the patient exhibits ventricular fibrillation Insufficient ECG signal quality Electromagnetic waves disturb the ECG signal Patient moved during analysis Device defective Repeat chest compressions Turn off the source of interference e g radio transmitter cellular...

Page 49: ...service police fire bri gade service 81 470 5 2 6 Mobile telephone system rescue service po lice fire brigade 81 470 100 11 7 RFID active and passive transponders and reading devices 433 865 868 0 5 0 85 1 62 It can be deducted from the table that portable RF telecommunication devices must not be used within a radius of 3 m from the device and its cables However there is no guarantee that no inter...

Page 50: ...maximum energy if device is stored used in optimal tem perature conditions between 15 25 C Several years in standby standby duration corresponding to laboratory tests at 25 C 6 years with weekly self tests Environmental conditions Device Operation Storage before use Storage and transport Battery and Electrodes Storage and Transport temper ature battery LiMnO2 Storage and transport temper ature ele...

Page 51: ...dy LNE G MED mark indicating its compliance with the provisions of the Directive 93 42 EEC modified by the Direc tive 2007 47 EEC regarding medical devices and fulfils the essential require ments of Annex I of this directive DefiSign Life AED is a class IIb device Patient Protection BF type resistant to defibrillation shocks Explosions protection DefiSign Life AED is not designed to be used in the...

Page 52: ... J or 15 the higher value is assumed SCHILLER s customer service department can change the default energy levels to the following values 70 90 120 150 200 J adults 30 50 70 J children automatic adaptation when paediatric pads are connected Cycle time rhythm analysis shock availability in semi auto matic mode With full battery After 15 discharges with max energy Maximum time between start of the an...

Page 53: ...he shock is not delivered within the 20 seconds after charging An electrode problem is detected Battery voltage is insufficient The device is defective The device is turned off Defibrillation pad connection BF type Defibrillation electrodes Adult and Paediatric pads Electrode cable 2 m in length 80 cm active surface Page 53 Technical Data 7 User Guide Defibrillation pulse 7 3 Art no 0 48 0240 Rev ...

Page 54: ...ect classification of a shockable rhythm true negative correct classification of a non shockable rhythm false positive non shockable rhythm incorrectly classified as a shockable rhythm false negative shockable rhythm incorrectly classified as non shockable Finally the results of the detector performance are reported in terms of specificity Sp TN TN FP true predictive value TP TP FP sensitivity Se ...

Page 55: ...le Voltage fluctuations IEC 61000 3 3 Not applicable 7 4 2 Electromagnetic immunity Interference testing IEC 60601 test level Conformity level Electromagnetic environment explanations Electrostatic dis charge IEC 61000 4 2 8 kV contact 15 kV air IEC 60601 1 conformity Floors should be made of wood concrete or ceramic tiles If floors are covered with synthetic material relative humidity should be a...

Page 56: ...flection on struc tures objects and people a The ISM frequency bands ISM industrial scientific medical between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The conformity levels within the ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2 5 GHz serve to minimise the probability of interferences ca...

Page 57: ...1 2 2 3 10 3 79 7 27 100 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance f...

Page 58: ...on and Emergency Cardiovascular Care 7 6 Glossary ABCD The primary ABCD A Airways check if airways are free B Breathing artificial respiration C Circulation circulatory signs or cardiac massage D Defibrillation AED Automated external defibrillator This term is also used for semi automatic defibrilla tors BLS Basic Life Support artificial respiration and cardiac massage CPR is frequently used synon...

Page 59: ...sories elapsed Date Performed by Checks once a Week once a Month Visual inspection of the device and accessories see previous table The main status indicator 1 is lit green an no others LEDs are blinking see 6 1 4 Mains status LED Date Performed by Checks every 3 years Visual inspection of the device and accessories see previous table Functional test Check for proper functioning see 6 1 4 Mains st...

Page 60: ...ge 37 Semi automatic Defibrillation 32 Design 15 Disinfection 43 Display Symbols Indicators in this User Guide 11 on the display 12 on the electrode packaging 13 used on the battery 12 used on the device 11 Disposal information Accessories into contact with patients 45 At the end of useful life 45 Battery 45 E Electrodes Adult and paediatric electrodes 29 Checking the electrodes 31 Open the electr...

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