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SCHILLER MEDICAL SAS FRED easy User Manual

Semiautomatic defibrillator, public access defibrillator, pad
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FRED easy
Semiautomatic Defibrillator (PAD)
User Guide
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- 0459
SCHILLER MEDICAL SAS
4, Rue Louis Pasteur
F-67162 Wissembourg – Cedex, France
Telephone **33 (0) 3 88 63 36 00
FAX **33 (0) 3 88 94 12 82
E-mail
info@schiller.fr
Part No. 0-48-0013

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Summary of Contents for SCHILLER MEDICAL SAS FRED easy

  • Page 1 ® FRED easy Semiautomatic Defibrillator (PAD) User Guide - 0459 SCHILLER MEDICAL SAS 4, Rue Louis Pasteur F-67162 Wissembourg – Cedex, France Telephone **33 (0) 3 88 63 36 00 FAX **33 (0) 3 88 94 12 82 E-mail info@schiller.fr...

  • Page 3: Table Of Contents

    1st edition 0-48-0013 09 January 2003 Revised Edition 0-48-0013 11 April 2003 Revised Edition 0-48-0013 24 June 2003 Revised Edition 0-48-0013 09 October 2003 Revised Edition 0-48-0013 10 July 2004 Revised Edition 0-48-0013 10 July 2006 Revised Edition FRED easy®...

  • Page 4: General Information

    General Information General Information ® • • FRED easy bears the CE mark The user guide informs the device operator CE-0459 about the intended use, exact function, op- indicating its compliance with the provisions eration and required preventive maintenance. of the Council Directive 93/42/EEC about It is not a substitute for a product training.

  • Page 5: Intended Use

    Typical sites for the installation of FRED easy® This document describes the semiautomatic units would be much-frequented buildings such version of FRED easy®. Refer to section 6.4 for information on operating the device in the auto- − airports matic mode.

  • Page 6: Product Description And Function

    Ensure Operational Readiness trode type and automatically preselects the corre- sponding energy levels for defibrillation. As soon as a battery is inserted, FRED easy® runs a self-test of the device and the battery. If The device prompts the operator by text and this test does not reveal any problems, the green audio messages (display/speaker).
  • Page 7 After that FRED easy® will ask the operator to start ECG analysis and warns not to touch the If the device again detects a shockable rhythm, it patient any more.
  • Page 8 Product Description and Function Device identifies no shockable rhythm If the algorithm does not identify a shockable ® rhythm, FRED easy informs the user that a shock is not necessary and prompts to perform CPR (30 chest compressions to every two breaths) until the patient starts breathing or until new instructions are given.

  • Page 9: Controls And Indicators

    Button to trigger the defibrillation shock Memory card g Battery ® ® Figure 3-2. FRED easy for semiautomatic and Figure 3-3. FRED easy for automatic defibrillation manual defibrillation FRED easy®...
  • Page 10 Do not destroy Unlimited storage between +15 °C and +25 °C, storage for 48 hours max. between +60 ˚C +25 ˚C +20 ˚C +25 °C and +60 °C and between +15 °C +15 ˚C 0 ˚C and 0 °C FRED easy®...

  • Page 11: Putting The Device Into Operation And Functional Test

    4.1 Safety Information − Devices may be connected to other devices Danger Explosion Hazard  FRED easy® is not de- or to parts of systems only when it has been signed for use in areas where an explosion made certain that there is no danger to the hazard may occur.
  • Page 12 As a general rule, the distance − Operational Readiness  FRED easy® is an between the defib pads and the HF surgery emergency device and must be ready for op- electrodes should not be less than 15 cm.

  • Page 13: Inserting The Battery

    As soon as a battery is inserted, FRED easy® runs must be visually inspected on a regular basis. If a self-test of the device and the battery.

  • Page 14: Nicd Batteries (Option)

    (these boards have a 12-digit serial number). To recharge these batteries, use the charging unit with part no. 3-55-0030. The charging time is 1 hour maximum. When equipped with the NiCd battery, the device runs a daily self-test. FRED easy®...

  • Page 15: Defibrillation

    FRED easy® only if local jurisdiction approves For this reason of this practice. Make sure that FRED easy® is - do not apply the defib pads near the only accessible to persons who are legally author- pacemaker, ized to use a PAD.

  • Page 16: Safety Information For The Use Of A Pad

    The patient must not be touched during analysis and shock delivery. Warning Patient Hazard  If, in the course of treatment, the patient spontaneously regains conscious- ness, a defibrillation shock that may have been advised just before must not be delivered. FRED easy®...

  • Page 17: Defibrillating The Patient

    To do so, stick on one vices. end of the pad, then smooth it out to the other end. Poor Electrode Contact — Sea water, sand and sunscreen products may impair electrode contact or the electrodes may become dis- connected. FRED easy®...
  • Page 18 If the message “Check the electrodes” does not disappear, • Remove the two defib pads. • Wipe rests of contact agent off with a cloth. • Shave the two application points to remove the epidermal skin layer. • Apply new defib pads to these points. FRED easy®...
  • Page 19 "Check the elec- trodes" will appear and the device sus- pends the analysis. The analysis contin- ues as soon as the high impedance is eliminated. FRED easy®...
  • Page 20 • Disconnect the electrode lead. • Carefully peel the pads off the patient’s skin (Figure 5-6). • Discard the disposable pads immediately after use to prevent that they are reused (hospital waste). Figure 5-6. Removing the defibrillation pads FRED easy®...
  • Page 21 Figure 5-8. Inserting the memory card (text facing into the device. up, insert in direction indicated by arrow) − Always turn off the device before inserting or removing the memory card. − Do not plug the Ethernet adapter into the slot. FRED easy®...

  • Page 22: Options And Variants

    (Figure 6-1). 00:13 00 100% A PRESS THE GREEN BUTTON Figure 6-1. Screen display with ECG waveform ® Figure 6-2. FRED easy for semiautomatic and manual defibrillation Switching to the manual mode Warning Patient Hazard  Only a physician is allowed to enable the manual mode.
  • Page 23 Switching to the semiautomatic mode To return to the semiautomatic mode, switch off ® FRED easy and leave it turned off for at least 5 minutes. FRED easy®...

  • Page 24: Ethernet Data Transmission (Option)

    Equipment Damage  Do not insert a mem- ory card into the Ethernet connector. • Plug the Ethernet adapter into the connector and make sure that it locks securely into place. • To remove the adapter, press on the locking lever (Figure 6-4). FRED easy®...
  • Page 25 The IP data (internet protocol) depend on the password for access to the server where the infrastructure of your network: data transmission software (Life Data Net) is − in "Static mode", your network administrator installed. will provide this information Figure 6-5. Configuration FRED easy®...

  • Page 26: Data Transfer

    At the end of the transmission procedure, the display shows: After a successful authentification, the internal ® Ethernet clock of FRED easy is synchronized with the server clock. CLOSE SESSION After an unsuccessful authentification, the follow- ing message appears:...
  • Page 27 CLOSING with server. recurs, the device must be repaired. DATA Erroneous data TRANSMISSION transmission DATA ERASING Internal error deleting Turn device off and on again; if message recurs, the data device must be repaired. FRED easy®...
  • Page 28 Figure 6-6. Placing the cable into the ferrite core Part No. Description 1-58-5300 Ethernet adapter 5-30-0003 Ethernet cable (3 m, category 5) 4-33-0002 Ferrite core Figure 6-7. Reducing the size of the loop Figure 6-8. Correctly installed ferrite core FRED easy®...

  • Page 29: Automatic Defibrillation (Variant)

    ® If a shock is recommended, the user receives a Figure 6-9. FRED easy for automatic defibrilla- tion warning about the imminent shock. The orange indicator blinks, and after a 4-second countdown the shock is delivered.

  • Page 30: Cleaning, Maintenance, Disposal

    Devices into which liquids have pene- trated must be immediately cleaned and checked by a service technician, before they can be reused. FRED easy®...

  • Page 31: Maintenance

    Replace the internal backup battery. Regular Checks The old batteries must be disposed of to local FRED easy® is an emergency device and must regulations. always be ready for use. The following checks The device does not require additional mainte- should be performed at regular intervals: nance interventions.

  • Page 32: Error Messages, Troubleshooting

    ERROR BATTERY − Battery problem − Turn device off and insert new batteries. CONFIGURATION DATA RESET TO DEFAULT > REINSERT BATTERY − Battery depleted − Turn device off and insert new batteries. BATTERY LEVEL INFO > REINSERT BATTERY FRED easy®...

  • Page 33: Troubleshooting

    − Insert new battery. Alarm tone does not stop. − Device defect. − Have device repaired. − Device defect. − Have device repaired. Message “Error xxx” − Battery almost depleted. − Insert new battery. Battery capacity indicator blinks. FRED easy®...
  • Page 34 − Have device repaired. card. − Internal clock error. − Have system parameters Incorrect date and time on updated by an authorized per- card. son (configuration kit for re- mote charging). − Device defect. − Have device repaired. FRED easy®...

  • Page 35: Technical Specifications

    − the device is turned off. max. energy: 25 seconds • Number of shocks with maximum energy (to EN 60601-2-4): 2500 25 Ohms 150 J 50 Ohms 75 Ohms 100 Ohms 125-175 Ohms time [ms] Figure 9-1. Discharge curve FRED easy®...
  • Page 36 − sensitivity: 98.43 % • Electromagnetic compatibility: specificity: 99.8 %; these values were de- termined with an AHA database containing − FRED easy ® uses radio frequency signals VF and VT with or without artifacts for internal control purposes only. The radio −...

  • Page 37: Order Information

    Resuscitation 2005. 2. 2005 American Heart Association: Guidelines for Cardiopulmonary Resuscitation and 1-58-9900 FRED easy® Emergency Cardiovascular Care. EASY T2 FRED easy® Trainer Accessories 0-21-0003 Disposable adhesive defibrillation electrodes for adults (1 pair), 78 cm 0-21-0000 Disposable adhesive defibrillation...
  • Page 38 Ethernet data transmission .........24, 26 Symbols ..............10 Explosion hazard ............11 Technical Safety Inspections ........31 Ferrite core, installation ..........24 Therapy, end.............20 Functional description..........6 Troubleshooting ............33 General information ............4 Variants..............22 HF surgery equipment ..........12 Warning, definition............4 Warranty ..............4 Immunity requirements ..........4 FRED easy®...
  • Page 39 Number : FRHOM0012 SCHILLER INSPECTION CHECKLIST – FRED EASY Index MEDICAL Page 1 / 1 Periodic Inspections: Weekly (devices that are frequently used) Monthly (devices that are infrequently used) SERIAL NUMBER: INSPECTION DATE INSPECTIONS RESULTS − insulation intact, no Visual Inspection mechanical damage −...

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