Schiller FRED easyport User Manual
Automated external defibrillator (aed)
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- Short operating instructions (4 pages) ,
- User manual (40 pages)
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Summary of Contents for Schiller FRED easyport
- Page 1 FRED easyport ® ® Automated external defibrillator (AED) ® ® FRED easyport User Guide...
- Page 2 Web: www.schiller.ch The FRED easyport bears the CE-0123 mark (Notified Body TÜV-SÜD Produkte Service GmbH, Ri- dlerstr. 65, 80339 Munich, Germany), indicating its compliance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality and labelling.
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Page 3: Table Of Contents
User Guide Table of Content Safety Notes ..........5 User profiles................5 Responsibility of the User ........... 5 Intended Use ................ 5 Contra-indication ..............6 Organisational Measures............. 6 Safety-Conscious Operation ..........6 Maintenance................7 General Safety Notes ............7 General Notes Regarding the Unit ........7 1.10 Terms of Warranty.............. - Page 4 4.3.1 Applying the electrodes..............26 4.3.2 Checking the electrodes ..............27 4.3.3 Device is not working, error message..........27 Defibrillation procedure ............. 28 Defibrillation in manual mode ........... 30 4.5.1 Finishing the therapy................ 32 Documentation of an Intervention ..33 Inserting the memory card..........33 Maintenance ..........34 Maintenance intervals ............
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Page 5: Safety Notes
Responsibility of the User The regulations governing the use and training requirements for devices such as the FRED easyport vary from country to country. In any case, legal regulations have to be observed. The numerical and graphical results as well as any interpretation suggested by the device must be examined with respect to the patient's overall clinical condition and the quality of the recorded data. -
Page 6: Contra-Indication
These operating instructions do not override any statutory or local regulations, procedures for the prevention of accidents or environmental protection. FRED easyport is an emergency device and must be ready for operation at any time and in all situations. Make sure that –... -
Page 7: Maintenance
Safety Notes User Guide Maintenance Maintenance Danger of electric shock! Do not open the device. There are 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. -
Page 8: Terms Of Warranty
The warranty is void if unauthorised or unqualified persons attempt to make repairs. In case the device is defective, send it to your local SCHILLER representative or di- rectly to the manufacturer. The manufacturer can only be held responsible for the safety, reliability, and performance of the apparatus if: •... -
Page 9: Symbols
Safety Notes User Guide Symbols 1.11 1.11 Symbols 1.11.1 Symbols used in this user guide The safety level is classified according to ISO 3864-2. The following overview con- tains the safety symbols and pictograms used in this user guide. For a possibly dangerous situation which could lead to severe personal injury or to death. -
Page 10: Symbols Used In Different Locations
Safety Notes 1.11 Symbols 1.11.2 Symbols used in different locations Manufacturer symbol Notified body of the CE certification 0xxx • CE 0123TÜV-SÜD Produkte Service GmbH • CE 408 TÜV AUSTRIA Service Note accompanying documents! Consult user guide! Symbol for the recognition of batteries as well as electrical and electronic equipment This unit must be disposed of in a municipally approved collection point or recycling centre. -
Page 11: Symbols Used On The Device
Safety Notes User Guide Symbols 1.11 1.11.3 Symbols used on the device BF symbol. The device's signal input is defibrillation-protected. IPX4 The device is protected against splashing water. Defibrillation electrode connector. This function must only be used by physicians or other authorised persons (see page 30). -
Page 12: Symbols Used On The Electrode Package
Safety Notes 1.11 Symbols 1.11.5 Symbols used on the electrode package • 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 Latex-free Use within one day after opening. -
Page 13: Components And Operation
For training purposes, SCHILLER offers the FRED easyport® TRAINER. Its small size and light weight make the FRED easyport the ideal companion of phy- sicians, paramedics, public service staff and other persons trained in early defibrilla- tion. Risk patients carry their own rescue device after they and their families have been instructed by their doctor. -
Page 14: Design
• Manual operation mode (see page 30) 2.2.2 Overview of the configurable settings The following settings can be configured by the SCHILLER after-sales service: • Voice volume • Energy level for 1st, 2nd and 3rd shock (separate settings for adults and children) •... -
Page 15: Operating Elements
Components and Operation User Guide Operating Elements Operating Elements Fig. 2.1 Operating Elements (1) Green button to switch the device on/off (2) Rubber seal for SD minicard (3) Yellow indicator lamp; lit as long as no electrodes are connected (4) Electrode connector (5) LCD screen (6) Blue button to start the analysis (7) Orange button: key to trigger a defibrillation impulse... -
Page 16: Display
Components and Operation Display Display The following information is displayed on the LCD: (1) Time passed and shocks delivered since the device has been switched on (2) Perform the function test at the next opportunity (see page section 6.1.3) (3) Memory card inserted and occupied memory in % –... -
Page 17: Function
Defibrillation procedure The user is guided through all operation steps by spoken and displayed instructions. The FRED easyport runs in semi-automatic mode. This means that the shock must be released by the user. When the device is switched on, the user is prompted to apply the electrodes to the patient. -
Page 18: Device Identifies A Shockable Rhythm
50 joules 150 Joules 50 joules 150 Joules 50 joules The SCHILLER service centre can define other settings if required (see section page 42). First shock After the shock, the user is prompted to: alternately carry out 30 chest compressions and give 2 breaths for 2 minutes. -
Page 19: Device Detects No Shockable Rhythm
Function 2.5.5 Device detects no shockable rhythm If the analysis program does not identify a shockable rhythm, the FRED easyport in- forms the user: • that no shock is required • that he or she should alternately carry out 30 chest compressions and 2 breaths for 2 minutes •... -
Page 20: Voice Support
Components and Operation Voice support Voice support Once the device is switched on, it runs a self-test and shows the software and hard- ware version. The following instructions will be spoken by the device: Voice Display Note Technical alarm: PLACE ON ELECTRODES Electrodes not connected. -
Page 21: Procedure In Case Of A Cardiac Arrest
Components and Operation User Guide Procedure in case of a cardiac arrest Procedure in case of a cardiac arrest This procedure applies to adults and children. •Collapse, cardiac arrest? •Unresponsive Call for help and alert the rescue ser- vice. Open the airways No normal respiration? Let an assistant prepare the and connect it, if possible. -
Page 22: Operation
(gasoline) or anaesthetics. Oxygenation in the vicinity of the defibrillation electrodes must be strictly avoided. Danger of electric shock! The FRED easyport is a high-voltage electric therapy device. Improper use of the device can endanger life. Always follow the instruc- tions given in this user guide. -
Page 23: Ensuring Operational Readiness
The ambient temperature should be in the range of 0...40 °C. Lower or higher ambient temperatures will have a negative impact on the battery's life. SCHILLER recommends always keeping a spare battery at hand. Function test The function test is performed by the user (see Function test page 36). -
Page 24: Defibrillation
Defibrillation Application guidelines 4 Defibrillation Application guidelines Observe the following guidelines to ensure successful and safe defibrillation. Other- wise, the lives of the patient, the user and bystanders are in danger. The patient: – must not come into contact with other persons during defibrillation. –... -
Page 25: Applying The Defibrillation Electrodes
Defibrillation User Guide Applying the defibrillation electrodes Applying the defibrillation electrodes Use the defibrillation electrodes only up to the indicated expiration date. Please note that the indicated expiration date only applies if the airtight packaging is in- tact. The electrode pads are pre-gelled, so there is no need to use extra contact gel. Do not reuse the pads. -
Page 26: Applying The Electrodes
Defibrillation Applying the defibrillation electrodes 4.3.1 Applying the electrodes Good contact between the skin and the adhesive electrodes must be ensured. Suntan oil, sand or salt reduce the adhesive quality. The applied pads must have good contact with the patient's skin, and air bubbles under the pads must be avoided. -
Page 27: Checking The Electrodes
Defibrillation User Guide Applying the defibrillation electrodes 4.3.2 Checking the electrodes If the resistance between the skin and an electrode is too high, a message is displayed and the yellow electrode LED (A) (fig. 4.2) remains lit. Proceed as follows: Alternately press down firmly on the defibrillation pads and check when the mes- sage disappears. -
Page 28: Defibrillation Procedure
Defibrillation Defibrillation procedure Defibrillation procedure When the device is switched on, it gives spoken and displayed instructions up to the defibrillation. Exactly follow the instructions. Step 1 Switching on and preparing the device 1. Switch the device on by pressing the green button (1). Electrode cable port 2. - Page 29 Defibrillation User Guide Defibrillation procedure Step 3 Shock delivery As soon as the energy for a shock is charged, the device prompts the user to deliver the shock by pressing button 3. Danger of electric shock! • Do not, under any circumstances, touch the patient during shock delivery. •...
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Page 30: Defibrillation In Manual Mode
• The device cannot be switched over to the manual mode during the defibrillation process (analysis, charging, shock release). • To operate the FRED easyport in semi-automatic mode again, it must be shut off and remain off for at least 5 minutes. - Page 31 Defibrillation User Guide Defibrillation in manual mode Shock delivery in manual mode Danger to the patient! Before you release the shock, check the displayed ECG curve to make sure that a shockable rhythm is present. Danger of electric shock! – Do not, under any circumstances, touch the patient during shock delivery. –...
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Page 32: Finishing The Therapy
Defibrillation Defibrillation in manual mode 4.5.1 Finishing the therapy Switch the device off as soon as the therapy is finished (keep the button pressed for approx. 3 seconds). Disconnect the plug of the electrode line. Carefully pull the electrodes off the patient's skin. Discard the disposable pads immediately after use to prevent their reuse (hospi- tal waste). -
Page 33: Documentation Of An Intervention
After inserting the card, close the plastic cover again. If the flashing symbol is displayed even though the card is inserted, check if the card is intended by SCHILLER for this device. Incorrect or defective cards can impair the device's operation! (See section Error detection 6.3) -
Page 34: Maintenance
Inspect the device and electrodes for the following: Device casing not broken or cracked Electrode connection undamaged? Schiller memory card inserted? Expiration date on electrode packaging Expiration date of the battery and spare battery Defective units or damaged cables must be replaced immediately. -
Page 35: Performing A Manual Self-Test
• The battery discharge due to the self-test is reduced to a minimum. Performing a self-test Press and hold the green button until the message “Manual TEST = OK” is displayed. The device shuts down automatically. SCHILLER EASYPORT SW CPU : V03.xxx SW Defi : V03.xxx... -
Page 36: Function Test
The message “Regeneration SUCCEEDED” is displayed. Function test not successful The message “Regeneration FAILED” is displayed. If this message is displayed, please contact your SCHILLER distributor. The device must not be used before it has been checked and repaired. Page 36... -
Page 37: Maintenance Interval For The Battery
Maintenance User Guide Maintenance intervals 6.1.4 Maintenance interval for the battery Important • The battery is maintenance-free during its normal life. • The spare battery has a life time of 5 years at room temperature storage condition. • Storage conditions outside the temperature range 15-25 °C will reduce the life time of the battery! •... -
Page 38: Cleaning
6.2.2 Accessories and disposables Always use SCHILLER replacement parts and disposables, or products ap- proved by SCHILLER. Failure to do so may endanger life and/or invalidate the warranty. Your local representative stocks all the disposables and accessories available for the FRED easyport. -
Page 39: Error Detection
Maintenance User Guide Error detection Error detection 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 ser- vice arrives. Forcing a shut-down !!! CAUTION !!! If the device cannot be shut off by means of the normal procedure (press and hold MAINTENANCE REQUIRED the green button for 3 seconds), remove and then reinsert the battery. - Page 40 Replace battery flashing • SCHILLER memory card not/ Switch off device and properly insert memory card not correctly inserted Replace card by a new SCHILLER card Symbol is not displayed • The card is defective • Memory card not detected be-...
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Page 41: Preventing Electromagnetic Interferences
It can be deducted from the table that portable HF telecommunication devices must not be used within a radius of 3 m from the FRED easyport and its cables. For transmitters not included in the above table, the recommended distance (d in me-... -
Page 42: Technical Specifications
Where nothing else is indicated, the data refers to a temperature of 25 °C. System Specifications Manufacturer SCHILLER AG Device name FRED easyport (First Responder External Defibrillator) Dimensions 35 x 133 x 126 mm (h x l x w) Weight 490 g... -
Page 43: Safety Standard
Technical Specifications User Guide Safety standard Safety standard DEFIBRILLATOR IEC/EN 60601-2-4 – the device is designed for more than 2500 shocks • IEC/EN 60601-2-4 • CISPR 11 class B The device can be exposed to the following interferences without impairment: •... -
Page 44: Defibrillation Impulse
Technical Specifications Defibrillation impulse Defibrillation impulse Shape • Biphasic pulsed defibrillation impulse with fixed physiological optimum phase du- rations • Near stabilisation of the emitted energy in function with the patient resistance us- ing pulse-pause modulation depending on the measured patient resistance. E = 150 J time (ms) Default energy settings... -
Page 45: Storage Of An Intervention (Option)
Technical Specifications User Guide Defibrillation impulse Safety discharge if: • the battery voltage is insufficient • the device is defective, • the device is turned off Shock delivery Via disposable adhesive electrode pads applied in the anterior-anterior lateral posi- tion Defibrillation electrode connec- BF type tion... -
Page 46: Appendix
Appendix Accessories 8 Appendix Accessories Article no. Article description 2.155061 Single-use defibrillation pads for adults 2.155067 Single-use defibrillation pad for children 2.155063 Single-use defibrillation pads for adults in box 2.155068 Single-use defibrillation pads for children in box 2.155065 Single-use defibrillation pads for adults (pre-connected) Battery LiMnO 2.230292 2.156047... -
Page 47: Glossary
Appendix User Guide Glossary Glossary ACLS Advanced Cardiovascular Life Support. (ACLS Manual AHA 2010) European Resuscitation Council Automated external defibrillator. This term is also used for semi-automatic defibrilla- tors (SAED). SAED Semi-automatic external defibrillator. The shock is released by the user. Basic Life Support (artificial respiration and cardiac massage) CPR is frequently used synonymously Cardiopulmonary resuscitation... -
Page 48: Inspection Report
Availability and condition • Electrodes and battery (expira- tion date and compatibility) • User Guide • SCHILLER memory card Only use a SCHILLER memory card! Incorrect cards can impair the unit's operation! • The standard screen is displayed. Performing the function test... -
Page 49: Index
Index User Guide 9 Index Accessories and disposables ..........Operating Elements ............. AED ..................Operational readiness ............Applying the electrodes ............Options ................Battery ................Recharging time ..............Battery life ..............Rhythm not shockable ............Battery disposal ..............Rhythm, Shockable ............. Battery type ................ - Page 50 Index Page 50...