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Table of Contents
Troubleshooting
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Summary of Contents for Schiller FRED PA-1 Series
- Page 1 FRED PA-1 Automated external defibrillator (AED) User Guide...
- Page 2 Sales and service information The SCHILLER sales and service centre network is world-wide. For the address of your local distributor, contact your nearest SCHILLER subsidiary. In case of difficulty, a complete list of all distributors and subsidiaries is provided on our internet site: http://www.schiller.ch...
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Page 3: Table Of Contents
FRED PA-1 User Guide Table of Contents Safety Notes ..........5 User profiles................5 Responsibility of the User ........... 5 Intended Use ................. 5 Contraindication for use ............6 Organisational Measures ............. 6 Safety-Conscious Operation ..........6 Operation with other Devices ..........7 Maintenance and Cleaning .......... - Page 4 FRED PA-1 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........27 4.2.4 Checking the electrodes ..............
- Page 5 FRED PA-1 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 Recommended minimum distances ..........
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Page 7: Safety Notes
In any case, legal regulations have to be observed. Before using the device, a SCHILLER representative must perform a presenta- tion on the device's operation and safety measures, if it is required by the local regulations. -
Page 8: Contraindication For Use
Immediately report any changes that impair safety (including operating behav- iour) to the responsible person. Only use original SCHILLER electrodes. Check that the unit's casing and electrode connections are not damaged. After use, refer to the chapter 6 Maintenance. -
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
Safety Notes FRED PA-1 User Guide Symbols/Indicators 1.11 1.11 Symbols/Indicators 1.11.1 Symbols used in this user guide The safety levels are classified according to ANSI Z535.6. The following overview shows the safety symbols and pictograms used in this user guide. The terms Danger, Warning, and Caution are used in this User Guide to point out poten- tial dangers and to indicate risk levels. -
Page 12: Symbols Used On The Battery
Safety Notes FRED PA-1 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- tion (see chapter 7 Technical Data) Battery must not be disposed of in the household waste... -
Page 13: Symbols Used On The Electrode Packaging
Safety Notes FRED PA-1 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 Storage temperature for the electrodes Expiry date of the electrodes An open package cannot be conserved more than one day. -
Page 14: Components And Operation
The parts of the product described in this user guide, including all accessories, that come in contact with the patient during the intended use, fulfil the biocompatibility re- quirements of the applicable standards. If you have any questions in this matter, please contact SCHILLER. Page 14... -
Page 15: Design
Components and Operation FRED PA-1 User Guide Design Design ® Defibrillator FRED PA-1 is a defibrillator featuring the BTE (biphasic truncated exponential) waveform. The patient receives a defibrillation shock using disposable electrodes. The ECG signal is analysed using the same electrodes. Moreover, the user is guided by voice prompts and pictograms (loudspeaker/LEDs next to pictograms). -
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 FRED PA-1 User Guide Operating and Display Elements Operating and Display Elements 2.3.1 Overview FRED PA-1 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 FRED PA-1 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
• 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 personnel authorised by Schiller) • An alarm (visual and/or acoustic) can only be reset by removing and reinserting the battery. -
Page 20: Initial Operation
Initial operation FRED PA-1 Inserting the battery 3 Initial operation ® Danger of explosion — The FRED PA-1 must not be used in areas where there is any 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
Initial operation FRED PA-1 User Guide Inserting the battery Remove the protective cap from the battery contacts before inserting the battery in the device. Insert the battery as indicated in the illustration on the left. <Click> 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. -
Page 22: Switching Device On And Off
Initial operation FRED PA-1 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
Initial operation FRED PA-1 User Guide Battery monitoring Battery monitoring • The lithium battery ensures that the device stays fully operative (and performs the self-test) for several years (at a temperature between 15 °C and 25 °C), provided that the device is not being used. •... -
Page 24: Battery Depleted During Use, Limited Mode (Cpr)
Initial operation FRED PA-1 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
Initial operation FRED PA-1 User Guide Replacing the “pre-connected” pads Replacing the “pre-connected” pads ® The FRED PA-1 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: ... -
Page 26: Defibrillation
Defibrillation FRED PA-1 Instructions and Safety Notes 4 Defibrillation Instructions and Safety Notes 4.1.1 Instructions ® • The FRED PA-1 is a high-voltage electrotherapy device. Only personnel authorised by local law are permitted to use these devices. Improper use can endanger life. ®... - Page 27 Defibrillation FRED PA-1 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
Defibrillation FRED PA-1 Applying the adhesive electrodes Applying the adhesive electrodes 4.2.1 General information The pads are sufficiently pre-gelled. Do not use extra contact agent. Do not reuse the pads. The pre-connected electrodes are stored in the defibrillator cover and can be ac- cessed when the cover is opened. -
Page 29: Applying The Electrodes To The Patient's Chest
Defibrillation FRED PA-1 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. Adult and paediatric electrodes Adult electrodes The adult electrodes with the blue connector are used for adults and children weigh-... - Page 30 Defibrillation FRED PA-1 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). Before applying the adhesive electrodes, verify that the application sites on the patient’s chest are clean and dry.
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Page 31: Checking The Electrodes
Defibrillation FRED PA-1 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 FRED PA-1 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. Step 1 Switching on and preparing the device Open the cover to switch the device on. - Page 33 Defibrillation FRED PA-1 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 FRED PA-1 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 FRED PA-1 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 FRED PA-1 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. Shock hazard! ...
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Page 37: Internal Safety Discharge
Defibrillation FRED PA-1 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 Every 6 years Note: 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
Maintenance FRED PA-1 Maintenance Intervals 6.1.1 Exemption from the technical safety inspection ® Exemption from the 3-year technical safety inspection is possible if the FRED PA-1 is exclusively used within the optimal conditions as stated below: Optimal factors Fulfilled Not fulfilled •... -
Page 41: Visual Inspection Of The Device And Accessories
Maintenance FRED PA-1 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 FRED PA-1 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. Risk of shock, equipment damage —... -
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. 6.3.1... -
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 FRED PA-1 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 FRED PA-1 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. 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.
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Page 48: Troubleshooting
Maintenance FRED PA-1 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
Maintenance FRED PA-1 User Guide Troubleshooting 6.5.3 Measures to prevent electromagnetic interferences The user can help avoid electromagnetic disturbances by keeping the minimum dis- tance between portable and mobile RF telecommunication devices (transmitters) and ® the FRED PA-1 . The distance depends on the output performance of the communi- cation device as indicated below. -
Page 50: Technical Data
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 ® FRED PA-1 Dimensions 310 x 255 x 100 mm (h x l x w) Weight Approx. -
Page 51: Classification And Safety Standards
FRED PA-1 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 FRED PA-1 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
2,475 couples of ECGs and transthoracic Impedance Cardiogram (ICG) from out- of-hospital cardiac arrest (OHCA) interventions, recorded with Automated External Defibrillators (FredEasy, Schiller Medical SAS, France) used by the fire brigade of Paris. This supplementary test completes the validation of the SAS and achieves the results summarised in table 1. -
Page 55: Electromagnetic Interferences
Technical Data FRED PA-1 User Guide Electromagnetic interferences Electromagnetic interferences ® The FRED PA-1 is intended for use in the electromagnetic environment specified be- ® low. The customer or the user of the FRED PA-1 should assure that it is used in such an environment. -
Page 56: Recommended Minimum Distances
Technical Data FRED PA-1 Electromagnetic interferences Conformity Interference testing IEC 60601 test level Electromagnetic environment - explanations level Recommended minimum distances Portable and mobile HF telecommunication devices must FRED keep the recommended minimum distance from the ® PA-1 and all its components, incl. cables; the recommended minimum distance is calculated based on the transmitter's fre- quency. - Page 57 Technical Data FRED PA-1 User Guide Electromagnetic interferences 7.4.3 Recommended minimum distances ® The FRED PA-1 is intended to be used in electromagnetic environments in which it ® is possible to control radiated HF interferences. The user of the FRED PA-1 can pre- vent electromagnetic interferences by always keeping a minimum distance between ®...
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Page 58: Glossary
Technical Data FRED PA-1 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) B = Breathing (artificial respiration)... -
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 FRED PA-1 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 Battery Battery Disposal ........
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What type of screwdriver do I need to purchase to open the FRED PA-1 as I need to take the battery out and put it back in again so that the system can tell Ive change the pads which were about to expire next month.