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Summary of Contents for Schiller DefiSign Life
- Page 1 User Guide DefiSign Life AED made by Schiller Automated external defibrillator (AED)
- Page 2 Manufacturer and responsible for the marking (first declaration October 2015) SCHILLER Medical S.A.S. Tel.: +33 (0) 388 63 36 00 4, rue Louis Pasteur Fax: +33 (0) 388 94 12 82 F- 67162 Wissembourg E-mail: quality@schiller.fr Web: www.schiller-medical.com...
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Page 3: Table Of Contents
Components and Operation ....12 General Information ............12 Design.................. 13 2.2.1 Overview of the configurable settings ..........14 Operating and Display Elements ........15 Overview DefiSign Life AED .............15 2.3.1 2.3.2 Display and Operating Elements............16 Function ................17 Initial operation ........18 Inserting the battery ............ - Page 4 DefiSign Life AED Defibrillation ..........24 Instructions and Safety Notes ........... 24 4.1.1 Instructions ..................24 4.1.2 Safety notes for AED use..............24 Applying the adhesive electrodes........26 4.2.1 General information ................. 26 4.2.2 Unpacking and applying electrodes ..........26 4.2.3 Applying the electrodes to the patient’s chest........
- Page 5 DefiSign Life AED User Guide Technical Data ........47 System Specifications ............47 Classification and safety standards ......... 48 Defibrillation pulse ............. 49 7.3.1 Shock Advisory System ..............51 Electromagnetic interferences .......... 52 7.4.1 Electromagnetic emissions .............. 52 7.4.2 Electromagnetic immunity ..............52 7.4.3...
- Page 6 DefiSign Life AED Page 6...
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Page 7: Safety Notes
Responsibility of the User ® Regulations on who is allowed to use devices like the DefiSign Life AED and which training is required, are country-specific. In any case, legal regulations have to be observed. -
Page 8: Contraindication For Use
25 %. The DefiSign Life AED must not be used in ambulances and emergency vehicles. Organisational Measures Before using the unit, ensure that an introduction regarding the unit functions and the safety precautions has been provided and understood. -
Page 9: Operation With Other Devices
Do not, under any circumstances, immerse the device or cable assemblies in liquid. To ensure patient safety, only use original SCHILLER accessories. The user is responsible for the use of third-party accessories. The warranty does not cover damage resulting from the use of accessories or consumables other than those marketed by SCHILLER. -
Page 10: Additional Terms
There are no express or implied warranties which extend beyond the warranties here- inabove set forth. SCHILLER makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof. -
Page 11: Symbols/Indicators
BF symbol. The device's signal input is defibrillation-protected. Caution! High voltage! CE-0459 marking (notified body LNE/G-MED). ® Do not dispose of the DefiSign Life AED and its accessories in the household waste. Manufacturer symbol, manufacturing date. Observe the user guide... -
Page 12: Symbols Used On The Battery
Safety Notes DefiSign Life AED 1.11 Symbols/Indicators 1.11.3 Symbols used on the battery 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-... -
Page 13: Symbols Used On The Electrode Packaging
Safety Notes DefiSign Life AED User Guide Symbols/Indicators 1.11 1.11.4 Symbols used on the electrode packaging • Remove the patient's clothes • Open the electrode packaging • Peel off the protective foil Disposable item; do not reuse Do not bend packing... -
Page 14: Components And Operation
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 ® . Some examples below: –... -
Page 15: Design
The device can be provided with different languages. Optional configuration with 3 languages, selectable after switching the device on. ® Metronome The DefiSign Life AED sets a configurable pace for the cardiopulmonary resuscitation (CPR). FreeCPR (option) Information on the chest compression frequency using impedance variation acquired with defibrillation pads. -
Page 16: Overview Of The Configurable Settings
These modifications need to be registered in the device documentation as well as communicated to all users. SCHILLER's service centre can configure the following parameters: Configurable parameters • Selection of the default language at device start •... -
Page 17: Operating And Display Elements
Components and Operation DefiSign Life AED User Guide Operating and Display Elements Operating and Display Elements 2.3.1 Overview DefiSign Life AED Service status LEDs: • Modem • Battery Main status LED • Service • Electrodes Battery The device is switched on when the cover is opened. -
Page 18: Display And Operating Elements
Components and Operation DefiSign Life Operating and Display Elements 2.3.2 Display and Operating Elements In addition to the voice prompts, the resuscitation steps are indicated by pictograms and the current step is highlighted with a flashing LED. Basic device with one language As soon the cover of the device is opened, the device starts issuing acoustic advices. -
Page 19: Function
Function Function ® Immediately after a battery has been inserted, the DefiSign Life AED performs a test of the device and battery. If this test is completed successfully, the green status LED is blink-ing and all service status LEDs are off, showing that the device has not detected an error. -
Page 20: Initial Operation
Inserting the battery 3 Initial operation ® Danger of explosion — The DefiSign Life AED must not be used in areas where there is an y danger of explosion. Areas may be susceptible to explosion if flammable substances (gas), flammable anaesthetics, or products used to clean or disinfect the skin are used. -
Page 21: Adding Emergency Numbers Stickers
Insert the two stop blocks located at the bottom of the battery in the device slots. Perform a rotational movement until the battery locks in place. ® As soon as the battery is inserted, the DefiSign Life AED runs a self-test to check the condition of the device and the battery. -
Page 22: Switching Device On And Off
Initial operation DefiSign Life AED Inserting the battery 3.1.2 Switching device On and Off Switching ON Open the cover. The 3 LEDs for the resuscitation 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. -
Page 23: Battery Monitoring
The old battery must be recycled in accordance with local regulations. 3.2.1 Sufficient battery capacity ® The main status 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 •... -
Page 24: Battery Depleted During Use, Limited Mode (Cpr)
Initial operation DefiSign Life AED Battery monitoring 3.2.3 Battery depleted during use, limited mode (CPR) Patient hazard — Defibrillation is no longer possible if a depleted battery is detected. The battery needs to 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. -
Page 25: Replacing The "Pre-Connected" Pads
User Guide Replacing the “pre-connected” pads Replacing the “pre-connected” pads ® The DefiSign Life AED is delivered with "pre-connected" pads. To replaced the pads after use or if the shelf life has expired, proceed according to the following instructions: Only use the pads up to their expiration date. -
Page 26: Defibrillation
Improper use can endanger life. • Non medical personnel is only permitted to use an AED such as the DefiSign Life ® if local law approves of this practice. - Page 27 Defibrillation DefiSign Life AED User Guide Instructions and Safety Notes Shock hazard — for user and assistants Position the patient flat on a firm, electrically insulated surface. Make sure that there are no conductive connections between the patient and other persons during ECG analysis and defibrillation.
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Page 28: Applying The Adhesive Electrodes
The pre-connected electrodes are stored in the defibrillator cover and can be ac- cessed when the cover is opened. A spare set of adult or children electrodes can be found in the compartment on the bottom of the DefiSign Life AED. 4.2.2 Unpacking and applying electrodes ... -
Page 29: Applying The Electrodes To The Patient's Chest
Defibrillation DefiSign Life AED User Guide Applying the adhesive electrodes 4.2.3 Applying the electrodes to the patient’s chest Skin covered in sea water, sand, sunscreen, or skin or body care products may impair electrode contact or cause the electrodes to become disconnected. - Page 30 Defibrillation DefiSign Life AED Applying the adhesive electrodes Children weighing less than 25 kg (younger than 8 years of age) Electrode placement on children weighing less than 25 kg (see Fig. 4.5 Application sites for children weighing less than 25 kg).
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Page 31: Checking The Electrodes
Defibrillation DefiSign Life AED User Guide Applying the adhesive electrodes 4.2.4 Checking the electrodes If the resistance (impedance) reaches an unacceptable value, the device interrupts and prompts the user to check the electrode application; in addition, the green indica- tor is blinking This can occur if: –... -
Page 32: Semi-Automatic Defibrillation
Defibrillation DefiSign Life AED Semi-automatic defibrillation Semi-automatic defibrillation Patient hazard — The guidelines given in 4.1 Instructions and Safety Notes must be observed. Semi-Automatic Defibrillation Depending on the configuration of the device, the instructions provided by the device may be shortened. - Page 33 Defibrillation DefiSign Life AED User Guide Semi-automatic defibrillation Step 3 Shock delivery When the energy is charged, the user is prompted to trigger the shock by pressing the blinking orange button. Shock hazard! Do not, under any circumstances, touch the patient during shock delivery.
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Page 34: Automatic Defibrillation
Defibrillation DefiSign Life AED Automatic defibrillation Automatic defibrillation The laws and regulations for the use of automatic defibrillators vary from country to country. While some countries allow laypersons to use automatic defibrillators without any special training, other countries restrict the use of AEDs to EMTs or First Re- sponders who have undergone special training. - Page 35 Defibrillation DefiSign Life AED User Guide Automatic defibrillation Automatic defibrillation Step 1 Switching on and preparing the device Open the cover to switch the device on. – If the cover is missing, remove the battery and insert it again to switch the device Assess the patient's condition: not responsive, no respiration, no pulse.
- Page 36 Defibrillation DefiSign Life AED Automatic defibrillation Step 3 Automatic shock delivery As soon as the energy charging is completed, the device automatically delivers the shock, without user intervention. An acoustic countdown starts and the orange button blinks until the shock is delivered.
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Page 37: Internal Safety Discharge
Defibrillation DefiSign Life AED User Guide Internal safety discharge Internal safety discharge If the device's behaviour differs from the description given in this user guide, the device is defective and must be repaired. An internal safety discharge ensures that the stored energy is discharged within the device every time a defibrillation shock was not delivered correctly. -
Page 38: Communication
Retrieving intervention data Only use standard SD cards (do not use mini or micro SD cards). • To read the intervention data, use the appropriate SCHILLER software. Contact your SCHILLER representative. To retrieve the intervention data, an SD card is required. The SD card must be con- figured according to the following instructions. -
Page 39: Maintenance
6.1.5 Functional check Note: Every 6 years The replacement of the internal backup battery is advised. Should this internal backup battery not be replaced every 6 years, SCHILLER can- not ensure the proper time stamping of the intervention. Page 39... -
Page 40: Exemption From The Technical Safety Inspection
– not placed on walls with risk of vibrations (e.g. near doors, windows, ...) Yes No Exemption from the technical safety inspection of the DefiSign Life AED if all factors are fulfilled Location: Date: Carried out by: 6.1.2... -
Page 41: Visual Inspection Of The Device And Accessories
Maintenance DefiSign Life AED User Guide Maintenance Intervals 6.1.3 Visual inspection of the device and accessories Regularly and after each use, inspect visually the device and the cables in order to detect possible mechanical damages. If you observe damages or dysfunctions which can endanger the safety of the patient or user, only use the device once it has been serviced. -
Page 42: Mains Status Led
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 at shorter interval. The regulations in force in each country regarding inspection frequency must be observed (if shorter intervals than those recommended by SCHILLER are im- posed). -
Page 43: Cleaning And Disinfection
Maintenance DefiSign Life AED User Guide Cleaning and disinfection Cleaning and disinfection Shock hazard — Remove the battery before cleaning the device. This ensures that the device will not be turned on inadvertently while you are cleaning it. Risk of death! Disconnect the defibrillation pads before cleaning the device. -
Page 44: Accessories And Disposables
. A full list of all SCHILLER representatives can be found on the SCHIL-LER website (www.schiller.ch). In case of difficulty, contact SCHILLER. Our staff will be pleased to help process your order or to provide details for all SCHILLER products. -
Page 45: Disposal Information
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. -
Page 46: Troubleshooting
Maintenance DefiSign Life AED Troubleshooting Troubleshooting • If it is not possible to get the device back into operating condition within a reason- able period of time, continue cardiopulmonary resuscitation until the rescue service arrives. Forced shutdown procedure • If the device cannot be switched off via normal OFF procedure (closing the cover) remove the battery and insert it again. - Page 47 Maintenance DefiSign Life AED User Guide Troubleshooting a. If 2/3 of the single measurements over 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.
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Page 48: Troubleshooting
Maintenance DefiSign Life Troubleshooting 6.5.2 Troubleshooting Forced shutdown procedure If the device cannot be switched off via normal OFF procedure remove the battery and insert it again. Problem Possible causes Remedy The Status indicator is not Replace the battery. -
Page 49: Measures To Prevent Electromagnetic Interferences
3 m from the device and its cables. However, there is no guarantee that no interference can occur in certain instal- ® lations. If the DefiSign Life AED causes interferences, these can be prevented by switching off the device. -
Page 50: Technical Data
Technical Data DefiSign Life AED System Specifications 7 Technical Data Unless otherwise stated, all specifications are valid at a temperature of 25 °C. System Specifications Manufactured by SCHILLER MEDICAL Device name ® DefiSign Life AED Dimensions 310 x 255 x 100 mm (h x l x w) Weight Approx. -
Page 51: Classification And Safety Standards
DefiSign Life AED is 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. Page 51... -
Page 52: Defibrillation Pulse
Default energy settings Accuracy at 50Ω: ± 3 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)... - Page 53 Technical Data DefiSign Life AED User Guide Defibrillation pulse Shock delivery • With the orange button (in semi-automatic) • Via disposable pads applied to the patient in an anterior-lateral or anterior-pos- terior position Safety discharge when: • A non shockable rhythm has been detected •...
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Page 54: Shock Advisory System
The bandwidth of the devices that recorded the signals is larger than that of the DefiSign Life AED®. However, when the analogue signals of the database are run on the DefiSign Life AED vi a electrode connector, the DefiSign Life AED rhythm detector signal-processing characteristics are applied. Moreover these signals are of appropriate length to allow decisions to b e made by the detector system. -
Page 55: Electromagnetic Interferences
® The DefiSign Life AED is intended for use in the electromagnetic environment specified be- ® low. The customer or the user of the DefiSign Life AED should assure that it is used in such an environment. 7.4.1 Electromagnetic emissions... -
Page 56: Recommended Minimum Distances
Technical Data DefiSign Life AED Electromagnetic interferences Conformity Interference testing IEC 60601 test level Electromagnetic environment - explanations level Recommended minimum distances Portable and mobile HF telecommunication devices must keep the recommended minimum distance from the ® DefiSign Life AED and all its components, incl. - Page 57 ® The DefiSign Life AED is intended to be used in electromagnetic environments in which it is possible to control radiated HF interferences. The user of the DefiSign Life ® can pre-vent electromagnetic interferences by always keeping a minimum distance between portable/mobile HF communication devices (transmitters) and the ®...
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Page 58: Glossary
Technical Data DefiSign Life AED Literature Literature European Resuscitation Council Guidelines 2015 for Cardiopulmonary Resuscitation and Emergency Cardiovascular (2015) Care American Heart Association (2015) Guidelines 2015 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Glossary ABCD The primary ABCD A = Airways (check if airways are free)... -
Page 59: Inspection Report
Date: Performed by: In case of problems, please notify your Biomedical Department , your local SCHILLER distributor , or the authorized Custom- er Service for your area Name: ..............Tel.: ..............Page 59... -
Page 60: Index
Index DefiSign Life AED 8 Index Accessories..........44 Maintenance Appendix Internal backup battery ......42 Glossary ..........57 Maintenance Intervals......39 Inspection Report ........58 Test............42 Literature ..........57 Visual inspection ........41 Order information ........56 Required accessories......44 Safety Notes ..........7 Self-test............19...
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Questions and answers
With the handle facing away from me the bottom red is LED flashing. The pads are due to expire in July but i have put new pads now the LED red light is still flashing. The machine is 3 years old the battery expiry date is 2031.