FRED 3 User Manual - JonAcc Ambulance Services
Contents
1. 9 48 T Telephone number enter 41 Telephone numbers enter eeeeeeeeeeeeeeeeeee 40 Test display isch sentais died 14 Therapy ends Ae Manin ei A 23 Time enter 2 0 eeeeseeecceeeeeceesseceeeeeeeaeeeseceeeeeeeaeness 40 V Voice prompts enable disable 40 Volume of audio signals adjust 40 W Warning definition 4 WarrantV 5 fs tire rite tant 4 Wrap around sensor 30 Y Y universal probe 29 FRED Version 42. Figure 8 2 Discharge curves at 360 Joules monophasic 42 FRED Version 4 Technical Specifications VT VF Detection Shock advised in the presence of VF and VT VT gt 180 B min Sensitivity 98 8 AHA and MIT Specificity 99 97 AHA and MIT Conditions for ECG analysis minimum amplitude for signals suitable for analysis gt 0 20 mV signals lt 0 2 mV are considered as asystole Definition Sensitivity correct identification of a shockable rhythm Specificity correct identification of non shockable rhythms Display LCD 130 x 70 mm alphanumeric presentation of measuring values and device settings dis play of symbols of the ECG option and of the plethysmogram option Sweep speed 25 mm s 5 ECG Signal Input optional Input without electrical connection to the applied part type CF defibrillation proof monitoring of the electrode to skin contact impedance Input impedance gt 2 5 Mohms DC input voltage 1 V max Patient leakage current lt 0 1 yA Frequency range 0 5 to 40 Hz 3 dB with 3 lead and 4 lead pa tient cable 0 05 to 150 Hz 3 dB only with 10 lead patient cable Common mode rejection gt 100 dB Control range 5 mV Recovery time after defibrillation shock 6s Heart Rate Indication Heart rate indication with digits Measuring range 10 B min to 300 B min Error 5 B min Minimum amplitude for triggering 0
3. Observe the following application guidelines Use pads before their expiration date Do not reuse the pads Shave the application points this improves conductivity and makes removal of the pads easier Place the pads on the patient such that the connectors point to either side of the patient and that the cables are not hindering CPR measures The electrodes are pregelled therefore do not use additional contact cream or gel Do not use pads if the gel is dry Peel off the backing from each pad and press the pad carefully onto the appropriate site Warning Risk of Skin Burns Equipment Damage Do not attach the pads over sternum or clavicle nipples implanted pacemaker or defibrillator devices e Connect the lead of the defibrillation pads to the device 5 Figure 2 1 FRED Version 4 19 Semiautomatic Defibrillation _ J ie SL Figure 4 3 Defibrillation pad application points patient in supine position 00 24 S 0 Fa PRESS FOR ANALYSIS Figure 4 4 lt 00 24 S 0 25 Press for analysis prompt ANALYSIS IN PROGRESS DO NOT TOUCH THE PATIENT Figure 4 5 Analysis in progress do not touch the patient message 200 24 S 0 Fa SHOCK ADVISED STAY AWAY Figure 4 6 Message when device identifies shockable rhythm e After connection of the electrodes the m
4. PRESS FOR ANALYSIS Figure 6 27 ECG transmission status display 00 24 20 ras 14903147 JANET PRESS FOR ANALYSIS Figure 6 28 Patient ID number After acquisition of the ECG the telephone number called appears on the display Figure 6 26 Once the communication link has been estab lished the device starts sending the ECG Figure 6 27 The transmission status is continually indicated arrow Figure 6 27 After the ECG transmission the patient ID num ber is displayed and sent to the PC Figure 6 28 FRED generates this patient ID number auto matically The ID is composed of the serial num ber of the device and a number incremented with each new patient The number increments only when FRED was turned off for at least 5 min utes between two patients 38 FRED Version 4 Defibrillator Setup 7 Defibrillator Setup Displaying the Setup Menu The defibrillator has a setup menu which allows you to permanently adjust many of the device functions to your preferred settings and to save them e To access the setup menu turn on FRED by simultaneously pressing the buttons and On Off The display shown in Figure 7 1 will appear ADJUST CONTRAST CONTROL PRESS PHONE KEY TO CONTINUE Configuration e Using the C button select menu item Con figuration and confirm the selection with 9 e Enter the password The Configuration menu appears for setup of the device Figure 7 3
5. button must be held down for approx 2 seconds For a functional checkout the device offers two different tests an automatic test which takes place at power up a manual test Automatic Power Up Test The test display appears immediately after the device is turned on Figure 3 2 If the device does not identify a problem it will enable the semiauto matic mode of operation and prompt you to con nect the electrodes If a problem is identified an alarm sounds and an error message will be displayed In this case turn off the device or interrupt the power supply by removing the battery Have the device repaired before using it again Note A data storage problem PCMCIA card does not affect the other functions of the device After the test the device switches to the semiautomatic mode The aR symbol blinks to alert to this problem The energy storage system test discharge can only be checked with a suitable simula tor Warning Shock Hazard In addition to the successful self test the performance test includes a visual inspection of the cables connectors elec trodes sensors and probes before each use If you identify problems which may impair the patient s or operator s safety the device must be repaired before it can be used again BIPHASI Spo2 Circe EPROM 25 10 2000 11 00 ENGLISH Figure 3 2 Automatic power up test Type of test Protocol used AHA
6. mission and confirm the selection with fy The modem will be activated and it will dial the first of the three telephone numbers you entered Fig ure 6 21 Once the communication link has been estab lished the data transmission will begin Transmis sion Progress The time required to complete the transmission is always indicated Figure 6 22 After the transmission the information about the session will be summarized on the display Figure 6 23 The transmission time is indicated in hours and minutes Erasing the PCMCIA Card The card erase function is protected with a pass word Only persons who know the password are able to erase data You will be prompted to enter the password after selection of the menu item Transmission Card Erase or Card Erase After you have entered the password see below the device either begins transmitting and then deleting data or you will see a message informing you that data are being deleted Enter the password by pressing the following buttons in the order shown Ay i red Analyse Shock button y A red Analyse Shock button 36 FRED Version 4 Optional Device Features Transmission of the 12 Lead ECG 6 6 Transmission of the 12 Lead ECG Some Basic Facts This option allows you to transmit a 10 second segment of the 12 standard ECG leads to a PC via a GSM cellular telephone For this type of transmission you need a GSM cellu
7. or repairs are carried out by SCHILLER or by persons authorized by SCHILLER the device is used in accordance with the in structions given in this operator s manual The customer is responsible if the device is employed in a manner different from that de scribed in this manual On request SCHILLER will provide a detailed field service manual e This manual is in conformity with the device specifications and safety standards valid at the time of printing All rights are reserved for de vices circuits techniques software programs and names appearing in this manual e The SCHILLER quality management system complies with the international standards EN ISO 9001 and EN 9001 e No part of this manual may be reproduced without written permission from SCHILLER e The safety information given in this manual is classified as follows Danger indicates an imminent hazard If not avoided the hazard will result in death or serious injury Warning indicates a hazard If not avoided the haz ard can result in death or serious injury Caution indicates a potential hazard If not avoided this hazard may result in minor personal injury and or product property damage Manufacturer 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 FRED Version 4 Intended Use Functional Description 1
8. Intended Use Functional Description 1 1 Intended Use The basic version of FRED is a semiautomatic defibrillator for early defibrillation by EMTs The defibrillator comes in two versions one deliv ers monophasic shocks while the other delivers biphasic shocks Depending on the defibrillator model the energy for semiautomatic defibrillation is set to the following values shock defibrillator model biphasic biphasic mono mono BUFREN phasic phasic BUFREN 1 shock 130 J 90 J 200 J 200 J 2 shock 130 J 130 J 200 J 300 J 3 and 180J 180 J 360 J 360 J all subse quent shocks EMTs are permitted to use the device in the semi automatic mode only if the local regulations ap prove of this practice The staff must be trained how to use the device and the defibrillation must be carried out under the supervision of a physician A special version of FRED is available for manual defibrillation As a general rule the device must be integrated in the chain of survival developed by the AHA Ameri can Heart Association and the ERC European Resuscitation Council This chain of survival comprises a series of actions performed by different persons Each of the actions is significant to ensure continued assistance for patients with cardiac arrest Time is the decisive factor in the creation of this chain The chain in cludes a number of supplementing and integrated phase
9. a shock although you suspect that a shockable arrhythmia exists the physician can manually charge the defibrillator and trig ger a shock Please note that children require less energy for successful ventricular defibrillation than adults With defibrillators delivering monophasic shocks For the first defibrillation shock delivered to babies and small children select an energy of approx 2 J kg body weight For subsequent shocks the energy may be increased to 4 J kg body weight AHA Guidelines 2000 for Cardio pulmonary Resuscitation and Emergency Cardio vascular Care page l 64 With defibrillators delivering biphasic shocks For the first defibrillation shock delivered to babies and small children we recommend an energy of approx 1 J kg body weight For subse quent shocks the energy may be increased to 2 J kg body weight You can choose from the following energy levels defibrillator delivering biphasic shocks 1J 2J 4J 6d 8d 15 J 30 J 50 J 70 J 90 J 110 J 130 J 150 J 180 J defibrillator delivering monophasic shocks 5J 10 J 15 J 20 J 25 J 30 J 40 J 45 J 50 J 100 J 200 J 300 J 360 J e Do not touch the patient any more and warn all those present e Initiate defibrillator charging with the A button The charging process can be watched on the defibrillator display When the charge level has been reached the message Defibrillator ready and the stored energy will be disp
10. and time e power on e start of analysis e analysis result e defibrillator charging e shock release e internal discharge e switchover to manual operation e electrode alarm e battery low alarm e putting the SpO module into operation e end of SpO measurement e asystole alarm manual mode e fibrillation flutter alarm manual mode 00 24 S0 Fa CHECK THE PULSE IF NO PULSE 1 MINUTE CPR Figure 4 10 Data storage function enabled Intervention Documentation To document the code the ECG 1 lead 5 hours max and the intervention 500 events max see overview at left are saved to a 2 MB PCMCIA card Always insert the card in the upper slot Figure 4 9 Inserting the card will automatically activate the memory function and the symbol appears on the display Figure 4 10 The number next to the symbol indicates the percentage of the storage capacity used When the storage capacity is exhausted the T symbol blinks when the memory function is dis turbed the x symbol blinks Note Insert the PCMCIA card in the upper slot only When the option FREDVO is installed voices within a radius of 3 m around the scene of the emergency can be recorded 0 5 h max The multimedia system FREDWARE or the SAED Reader Pro software is required to read and clear the PCMCIA card in the transmission mode the card can also be cleared while inserted in FRED section 6 5 Alarms FRE
11. battery s service life FRED automatically monitors the battery capacity As soon as the capacity drops below a given minimum 30 minutes of operation or 7 shocks at 180 Joules each or 5 shocks at 360 Joules each the symbol appears Indicator 16 will light up even when no battery is inserted for charging o battery HO Figure 3 1 Charger cable connection Charging Unit DG 2002 C2 The charging unit is suitable for fast charging of one or two NiCd batteries It is specially designed for these batteries and ensures optimal performance and a long service life of the batteries e Connect the charger to the power line e Turn the charger on switch below power input e Immediately after inserting a battery the charge cycle begins indicator is illuminated It takes 1 hour to quick charge a fully depleted battery Afterwards the charger switches to trickle charging indicator blinks Lithium Battery Handle lithium batteries acoording to the follow ing guidelines Store lithium batteries in a well ventilated room at a constant temperature between 15 C and 20 C Do not store batteries longer than 10 years residual capacity of 80 Protect lithium batteries from Strong vibrations hard shocks flammable materials pointed objects 12 FRED Version 4 Putting the Device into Operation and Performance Test The ambient temperature has a majo
12. circuit do not incinerate do not destroy with a saw UK UND EE A gt co do not destroy nel Loc a oc eT unlimited storage between 10 C and 20 C storage for 48 hours max between 20 C and 70 C and between 10 C and 30 C eS replace battery after 1 year of opera tion dramatically reduced capacity see page 44 FRED Version 4 Putting the Device into Operation and Performance Test 3 Putting the Device into Operation and Performance Test 10 3 1 Safety Information Danger Explosion Hazard FRED is not designed for use in areas of medical locations where an explosion hazard may occur Also it is not permitted to operate the defibril lator in an oxygen enriched environment or in the presence of flammable substances gas or anesthetics Oxygenation in the vicinity of the defibrillation electrodes must be strictly avoided Tempo rarily interrupt the oxygen supply Warning Shock Hazard Observe the following warn ings Failure to do so endangers the lives of the patient the user and other persons pre sent FRED is a high voltage electrotherapy device and must be handled by qualified and specially trained personnel Improper use of the device can endanger life Always follow the instructions given in this manual Before using the device the operator must ascertain that it is in correct working order and operating cond
13. not be allowed to en ter the device Caution Equipment Damage Do not disinfect the device surface with phenol based disinfectants or peroxide compounds FRED Version 4 25 Cleaning and Maintenance 5 2 Maintenance Checks before each use e Before each use visually inspect the device the leads and electrodes If you detect damages or impaired functions which may result in a hazard to the patient or the opera tor the device must be repaired before it can be used again Regular Checks FRED is an emergency device and must always be ready for use The following checks should be performed at regular intervals Once a week e visual inspection of the device and the accesso ries Once a year These inspections can be carried out by SCHILLER service technicians within the frame work of a maintenance agreement If other persons perform these inspections please ensure that they have received adequate training and are experi enced in carrying out preventive maintenance checks e Visually inspect the device and the accessories for signs of mechanical damage that may impair the device functions Replace damaged parts immediately e Check that the device labeling relevant for safety is legible Labeling which is missing or illegible must be renewed e Perform functional test using the manual test feature e Measure the equivalent leakage current e Measure the energy delivered in 50 Ohms e C
14. person responsible for the inter vention may use the device in the semiauto matic mode In the semiautomatic mode the defibrillator cannot deliver synchronized shocks cardio version During HF surgical interventions ECG analy sis is not permitted in the semiautomatic mode Caution For semiautomatic defibrillation the energy is fixed at the following levels defibrillator delivering biphasic shocks 1 shock 130 J or 90 J 2 shock 130 J 3 and all subsequent shocks 180 J defibrillator delivering monophasic shocks 1 shock 200 J 2 shock 200 J or 300 J 3 and all subsequent shocks 360 J Note When testing FRED with an ECG simulator be aware that most simulators generate artificial ECG waveforms These signals are only suitable for a functional test of the device but not for an evaluation of the analysis program With signals from the AHA American Heart As sociation and MIT Massachusetts Institute of Technology databases our analysis program achieved a detection accuracy of 98 8 sensitiv ity and 99 97 specificity FRED Version 4 17 Semiautomatic Defibrillation 4 3 Guidelines Conditions Limitations and Restrictions in Use Some Basic Facts EMTs are permitted to use a semiautomatic defi brillator only if the local regulations approve of this practice In addition it is of utmost importance to observe the safety information given in sections 4 1 and 4 2 Warning Pa
15. 0 C in the original case sufficient for 4 5 hours of monitor opera tion or 400 shocks of 180 J each Operational Readiness e Immediately after automatic power on test Environment e Transport storage temperature 30 to 50 C relative humidity 30 to 95 no condensation atmospheric pressure 500 to 1060 hPa e Operation temperature 0 to 50 C relative humidity 30 to 95 no condensation atmospheric pressure 700 to 1060 hPa protection category IP 23 inside instrument bag IP 20 outside instrument bag charger con nected Dimensions and Weight e width 260 mm depth 255 mm height 90 mm weight 4 2 kg with battery and accessories 44 FRED Version 4 Order Information 9 Order Information Part No FREDBI FRED Accessories Defibrillation W1410241 W 1404262 ECG U50063 W 1409608 W 1402037 72365 Description FRED basic device biphasic FRED basic device monophasic Disposable adhesive defibrillation electrodes for adults 1 pair Disposable adhesive defibrillation electrodes for children 1 pair ECG patient cable 4 lead cable red yellow green black elbow connector with clip connection ECG patient cable 3 lead cable red yellow green elbow connec tor with clip connection ECG patient cable 10 lead cable elbow connector with clip connec tion Adhesive ECG electrodes for adults 34 mm diam 50 case SpO Measurement U50153 U50106 U50
16. 105 W 1401977 W 1402254 W 1402377 Finger probe Y probe Oxilink for Y probe Flexible probe for neonates Flexible probe for children Disposable finger probe for adults 10 case Part No W 1402378 W 1402379 W 1402380 W1401994 U50072 Description Disposable probe for body weight between 15 and 45 kg 10 case Flexible disposable probe hand foot for body weight between 3 and 15 kg 10 case Flexible disposable probe hand foot for body weight lt 3 kg 10 case Disposable fixation straps for SpO probes 40 case Extension cable 1 5 m General Accessories W 1405387 BUFRLI BUFRNC W 1405308 W 1405309 W1411876 W1411877 W 1405307 FRED Version 4 User s Manual Lithium battery NiCd battery 12 V 2 4 Ah Accessory bag Carrying bag PCMCIA card 2 MB PCMCIA card 10 MB Wall mount system for cars 45 Literature Literature 1 46 American Heart Association Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care ISBN 0 87493 325 0 European Resuscitation Council 1998 Guidelines for Resuscitation ISBN 0 444 82957 1 Jost D et al 1998 Exp rience fran aise de la d fibrillation semi automatique JEUR 3 124 131 FRED Version 4 Index Index A AC line filter frequency ACCOSSOMO S si ist rs cece ressent Rates t a ist ni rates te American Heart Association 5 Annual inspections 26 Application in moist environm
17. 2 33 Manual t st ie an oaan en 15 Mod r EE AT E E 35 Moist environment 11 N NiCd battery 6 44 NIEA ET E pa Ae A E E E EE N 35 O OPHONS a ns Wats natant E T 6 Order information ss 45 P Packaging material disposal 11 Pads removal from patient 23 PartlinUMBO Sis sai cock esdevedeceasnttovercaausatvdverstwacueventvarerd 45 PassWord toata o iie ar a a AS 36 Patient ID number 38 PCMCIA card 6 24 PCMCIA card eject button 9 PCMCIA card erasing data 36 Performance test 14 Plethysmogram 2 5 8 doe aun tin dent 31 PoWer SUPPIV rt anne aay 6 12 47 Index Pulse oximetry 2238 n anal 28 Putting the device into operation 10 R Reproduction of manual 4 Restrictions in USC ee eeeeeeeeesseeeeeeeneeeteneeeeteneeeeeees 18 S Safety discharge cccceesecesseeeeseeteeeeeeeteeeeeaeetea 23 Safety information for the use of a semiautomatic d fibrillator 152 24t msenmrtiinmnemeimns 17 Safety information putting the device into operation 10 Semiautomatic defibrillation 17 Setup MENU iii canna eh 39 Shock delivery s siesic sts deeseseneiste Him Rapides ae 21 Shockable rhythm 20 Software version 4 Specifications sssini eti eea 42 SpO2 measurement 28 eO aE E E D rte dresser ser tornade ete ete 31 Symbols explanation
18. 2 mV Minimum QRS width 5ms Baseline correction after overranging after 200 ms Memory Storage of ECG 5 h max and code related events 500 max on 2 MB PCMCIA memory card or option storage of up to 0 5 hours of ECG data 0 5 hours of ambient noise 500 events on 10 MB PCMCIA memory card The multimedia system FREDWARE or the SAED Reader Pro software is needed to read the PCMCIA memory card SpO Measurement Type CF signal input defibrillation protection by probe Probe finger or Y probe Measuring range 0 100 Recovery time after defibrillation shock 8s or 16 s as configured Error 70 to 99 O 50 to 69 O Integration time 8or16s Signal strength indication with bar graph 2 3 Amplitude adjustment automatic FRED Version 4 43 Technical Specifications Power Supply Internal Power Source slot in rechargeable battery e NiCd 12 V 2 4 Ah e Sufficient for 2 5 hours of monitor operation or 110 shocks of 180 J each e Charging with FRED AC power adapter e Charge time 20 hours to reach 80 of its capacity 27 hours to reach 100 of its capacity or from slot in lithium battery e Sufficient for 5 hours of monitor operation or 450 shocks of 180 J each at 20 C or e After 1 year of daily functional tests and device not used sufficient for 2 hours of monitor opera tion or 150 shocks of 180 J each at 20 C or e After 5 years of storage at 2
19. A NiCd battery powers the device for 2 5 hours of monitoring or 90 shocks at 180 Joules or 60 shocks at 360 Joules The lithium battery powers the device for five hours of monitoring or 450 shocks at 180 Joules each or 300 shocks at 360 Joules see also section 3 2 Power Supply BUFRMAN The following options can be ordered to expand the device functions Note BUFRERC This manual describes a device with all options BUFREN implemented The explanations given in this manual may therefore refer to controls or func tions which are not available in the device you purchased FREDVO Furthermore we assume that the factory de faults are active If the settings differ from the factory defaults see chapter 7 Defibrillator Setup your device may behave differently FREDWARE MODEM1 6 FRED Version 4 ECG Display for display of the ECG waveform acquired via pads or ECG electrodes SpO measurement internal SpO measurement option includes finger probe and extension cable ECG signal acquisition via separate 3 lead patient cable requires BUFRDI option for display of the ECG includes 3 lead patient cable electrodes Acquisition of a 12 lead ECG for transmission via GSM to specific software requires modem MODEMGSM and software SEMA200 as well as the BUFRDI option for ECG display includes 10 lead patient cable Manual defibrillation permits selec tion of defibrillation energy manual shock release in
20. AED Reader Pro for laptop equipped with PCMCIA drive in cludes SAED Reader Pro software and hardware key to read and ana lyze the data stored on the PCMCIA card for laptop which meets the following minimum requirements Pentium II 300 MHz Windows 95 98 or NT O O O ANALYSE SCHOCK Figure 1 1 FRED equipped with option for manual defibrillation FRED Version 4 Controls and Indicators 2 Controls and Indicators Figure 2 1 Controls and indicators So O AR DO DN aS N 10 11 Contrast adjustment buttons Button to start data transmission via modem SpO probe connection ECG patient cable connection Connection for defibrillation pads Indicator blinks when the defibrillation pads are not properly connected or are missing connector defect cable break Microphone Analyse orange Shock red button Indicators Analyse green Shock red green push button to initiate analysis red push button to release the shock Physician button converts the device from semiautomatic to manual operation Button to increase the defibrillation energy manual operation First Responder External Defibrillator EIN Aus 12 Button to decrease the defibrillation energy manual operation 13 Button to initiate defibrillator charging man ual operation 14 Button to turn the device on and off hold button down for a
21. CONFIGURATION FACTORY DEFAULT IDENTIFICATION PHONE PHONE Next PLUS MINUS Select Figure 7 1 Power on display Now you can adjust the contrast The contrast cannot be adjusted later because the contrast buttons are needed to control the device during setup e Press the C button A menu with the following options appears Figure 7 2 Configuration device setup Factory Default select to restore the factory defaults Identification for service only Phone select to enter the telephone numbers for data transfer via modem All menu items are password protected see bot tom of page 34 Figure 7 2 Menu The operating steps for setup of the device are always the same e With O you position the bar cursor on the item to change and make the adjustment with 8 and CONFIGURATION o7 a 2000 ENS DD O2 average VT Alarm Figure 7 3 Configuration menu FRED Version 4 39 Defibrillator Setup Example You would like to choose another language e Press repeatedly until the bar cursor high lights the current language e Use or to select the new language e Once you have made all necessary changes press the red Analyse Shock button to exit the configuration menu Device Settings Factory Defaults Date Time Date format Language Filter fre quency Speech synthesis Sound level SpO aver age VEN
22. D distinguishes between technical and medi cal alarms If a medical alarm is present the device emits a continuous tone in case of technical alarms the device sounds an intermittent tone In most alarm situations the alarm tone is accompa nied by a voice prompt 24 FRED Version 4 Cleaning and Maintenance 5 Cleaning and Maintenance 5 1 Cleaning and Disinfection Device and Cables Danger Shock Hazard Remove the rechargeable battery before cleaning the device This en sures that the device will not be turned on in advertently while you are cleaning it Danger to life Before cleaning the paddles discon nect them from the device Shock Hazard Equipment Damage Liq uids must not be allowed to enter the device Devices into which liquids have penetrated must be immediately cleaned and checked by a service technician before they can be reused Discard disposable electrodes immediately after use to prevent that they are reused hospital waste Before cleaning the electrode or sensor leads disconnect them from the device Clean and disinfect cables by wiping them down with a gaze pad moistened with cleaning agent or dis infectant Do not immerse the cable connectors in liquid The device can be cleaned with all cleaning agents and disinfectants commonly used in hospitals The device surface too can be wiped down with a cloth moistened with a cleaning solution or disinfectant Liquids must
23. ERC Software version tested Energy for shocks 1 2 and 3 Selected language Date and time Pulse shape Device options Serial number of the device NN O O1 OC ND 14 FRED Version 4 Putting the Device into Operation and Performance Test Manual Test The manual test can be initiated at power up by simultaneously pushing buttons On Off and R To ensure functional readiness the device will automatically perform this manual test every day at 12 00 hrs even when switched off for these tests however the display remains dark If the device identifies a problem in the course of the test it emits an alarm at 2 minute intervals and briefly displays an error message Initiate the manual test to clear the alarm With a full battery the device can run these tests for a minimum of 4 weeks When you start the manual test at power up you can check the keyboard for proper functioning after the RAM and EPROM tests For this test push the button you are prompted to activate on the display beginning with the red Analyse Shock button 8 Note You can interrupt the manual test at any time with On Off We recommend to run a manual test each time the battery is replaced to check the battery capacity Microphone 3 Zane RESS ANALYSIS KEY KEYBOARD TEST Figure 3 3 Manual test at power up Type of test Protocol used AHA ERC Software version tested Energy for shocks 1 2 an
24. FRED Semiautomatic Defibrillator Version 4 User Guide SCHILLER MEDICAL SAS 4 Rue Louis Pasteur F 67162 Wissembourg Cedex Telephone 33 0 3 88 63 36 00 FAX 33 0 3 88 94 12 82 E mail info schiller fr Part No W1405387 THE ART OF DIAGNOSTICS Contents 1 Intended Use Functional Description 1 1 Intended Use 1 2 Functional Description 2 Controls and Indicators 3 Putting the Device into Operation and Performance Test 3 1 Safety Information 3 2 Power Supply 3 3 Turning the Device On and Testing Its Performance 4 Semiautomatic Defibrillation 4 1 Defibrillator Application Guidelines 4 2 Safety Information for the Use of a Semiautomatic Defibrillator 4 3 Guidelines Conditions Limitations and Restrictions in Use 4 4 Defibrillating a Patient in the Semiautomatic Mode 5 Cleaning and Maintenance 5 1 Cleaning and Disinfection 5 2 Maintenance 6 Optional Device Features 6 1 ECG Display 6 2 Patient Cable and ECG Electrode Connection 6 3 SpO Measuring System 6 4 Manual Operation 6 5 Transferring Data from a PCMCIA Card 6 6 Transmission of the 12 Lead ECG 7 Defibrillator Setup 8 Technical Specifications 9 Order Information Appendix Literature Index Revision History Version Date Comment W 1405387 29 January 2001 1 edition W 1405387 20 May 2003 2 edition W 1405387 07 October 2003 3 edition FRED Version 4 o1 O1 10 10 12 14 42 45 46 47 General Information G
25. RED Version 4 21 Semiautomatic Defibrillation Device identifies no shockable rhythm Device with AHA protocol If the analysis program does not detect a shock able rhythm the message No shock advised check the pulse If no pulse 1 minute CPR Figure 4 7 appears After that minute you will see the message Check the pulse If no pulse press for analysis The audible prompt for this action will be repeated every 2 minutes 200 24 S 0 Fa CHECKTHE PULSE IF NO PULSE 1 MINUTE CPR Figure 4 7 Message when device identifies no shockable rhythm Note The message Check the pulse If no pulse 1 minute CPR will also appear when the ECG sig nal quality is insufficient for a correct analysis Device with ERC protocol If the analysis program does not detect a shock able rhythm the message No shock advised check the pulse If no pulse 3 minutes CPR Figure 4 7 appears If the analysis was performed after a shock the message will read 1 minute CPR instead of 8 minutes CPR After these 3 minutes you will see the message Check the pulse If no pulse press for analysis Note If the device is turned on and the analysis program detects asystole the message Check the pulse If no pulse 3 minutes CPR appears If the analysis program detects asystole after a shock the message Check the pulse If no pulse 1 minute CPR appears If asystole persists af
26. T 40 enter day month year format DD MM YY or month day year format MM DD YY enter hours minutes choose the date format DD MM YY or MM DD YY choose the language frequency of the AC line filter 50 Hz 60 Hz select to enable and disable the voice prompts and to adjust the volume off high middle low select to adjust the volume of alarm tones and of the QRS beep off high middle low off means no QRS beep but low volume for alarm tones SpO averaging integration time 16 8 s select if you wish to be alerted to ventricular fibrillation and tachy cardia HR greater than 180 B min in manual mode Restore Factory Defaults The menu item Factory Default allows you to restore the factory defaults in the table at left the factory defaults are shown in angular brackets The function does not affect these settings Date Time Date format Language Filter frequency These settings will not be restored Entering the Telephone Numbers for Data Transmission The menu item Phone allows you to enter six telephone numbers which the device will dial automatically three numbers for transmission of the data from the PCMCIA card and three numbers for transmission of the 12 standard ECG leads In addition you can enter 2 initialization sequences for the modem one sequence for the external modem transmission of the data from the PCMCIA card on
27. able the manual mode while the defibrillator is charged or while the device is analyzing the ECG Enabling the manual mode does not reset the counter for the delivered shocks to 0 To return to the semiautomatic mode turn the device briefly off and on again 32 FRED Version 4 Optional Device Features Manual Operation Manual Defibrillation In the manual mode you can still initiate ECG analysis with the red Analyse Shock button you must initiate defibrillator charging with the A button the device selects the following energy levels defibrillator delivering biphasic shocks 1 shock 130 J or 90 J 2 shock 130 J 3 and all subsequent shocks 180 J defibrillator delivering monophasic shocks 1 shock 200 J 2 shock 200 J or 300 J 3 and all subsequent shocks 360 J the device automatically selects synchronized defibrillation if an ECG signal is available message SYNC next to the QRS blip Figure 6 15 The ECG signal can be acquired either via the pads or via ECG electrodes If an ECG signal is not available the device will select non synchronized defibrillation after 3 seconds message SYNC disappears Remember For synchronized defibrillation car dioversion the defibrillation shock is delivered in synchronization with the heart action because the heart is still working As a prerequisite the patient s ECG signal must be supplied to the defibrillator After the physician has gi
28. an Initialization Sequence e Using i or amp select either CARD Hayes or 12 LEAD Hayes Using C move the cursor to the position whose character you want to change Use f or to choose the character and enter the Hayes sequence separation by blanks Do not enter the prefix AT because FRED adds it automatically for the Hayes se quence please refer to the instruction manual that comes with your modem or cellular tele phone With the red Analyse Shock button you can delete the entire sequence for safety reasons you must press the button twice When you have entered the full sequence position the cursor on Type and press the red Analyse Shock button to quit the function FRED Version 4 41 Technical Specifications 8 Technical Specifications Defibrillator biphasic e Defibrillation energy levels in manual mode delivered into 50 ohms 1 2 4 6 8 15 30 50 70 90 1 130 150 and 180 Joules e Defibrillation energy levels in semi automatic mode delivered into 50 ohms either 130 130 180 Joules or 90 130 180 Joules e Error 15 or 2J 10 e Capacitor charge time with full rechargeable battery after 15 shocks of 180 Joules 6s Defibrillator monophasic e Defibrillation energy levels in manual mode delivered into 50 ohms 5 10 15 20 25 30 35 40 46 50 100 200 300 and 360 Joules e Defibrillation energy leve
29. arefully check the electrode cables for me chanical damage short circuits and lead breaks The device does not require additional mainte nance interventions Disposal at the End of Its Service Life At the end of its service life the device and the accessories must be disposed of in compliance with the local regulations Apart from the internal and slot in rechargeable battery the device does not contain hazardous material and may be dis posed of like any other electronic equipment 26 FRED Version 4 Optional Device Features ECG Display 6 Optional Device Features 00 24 0 F5 ACC sann PRESS FOR ANALYSIS Figure 6 1 Screen with ECG waveform heart rate and QRS blip Figure 6 2 Electrode application points 3 lead patient cable green black Figure 6 3 Electrode application points 10 lead patient cable 6 1 ECG Display This option allows you to view the ECG waveform the heart rate numeric value and the QRS blip heart symbol on the display Figure 6 1 If an ECG signal is not available because neither pads nor ECG electrodes are applied but an SpO sensor is connected the pulse rate will be displayed instead of the heart rate and the letter S replaces the QRS blip 6 2 Patient Cable and ECG Electrode Connection This option allows you to acquire the ECG signal via pads or separate ECG electrodes Depending on the option yo
30. ce temperature may increase to an inadmissible level due to the internal safety discharges 11 Putting the Device into Operation and Performance Test 3 2 Power Supply The device can be powered from a rechargeable NiCd battery with 2 4 Ah or from a disposable lithium battery A NiCd battery powers the device for 2 5 hours of monitoring or 110 shocks at 180 Joules bi phasic or 60 shocks at 360 Joules monopha sic A lithium battery provides power for 5 hours of monitoring or 450 shocks at 180 Joules or 300 shocks at 360 Joules For recharging the NiCd battery may remain in the FRED defibrillator or it can be inserted in the external charging unit see section Charging Unit DG 2002 C2 below Charge the battery immediately after each use and leave the charging unit connected to the defibrillator The battery cannot be overcharged After 20 hours of charging the battery has reached 80 of its capacity after 27 hours 100 e Connect the charger cable to connector 15 Figure 3 1 and to the power line Caution Indicator 16 will light up even when no battery is inserted for charging Note It is not possible to operate FRED with out a charged battery Do not recharge NiCd batteries in direct sunlight on sources of heat or at ex tremely low ambient temperatures mini mum temperature 5 C 41 F The ambi ent temperature should not exceed 40 C 104 F as this would have adverse effects on the
31. cludes ECG display BUFRDI ERC protocol instead of AHA protocol Energy levels for biphasic shocks in semiautomatic mode 1 shock 90 J 2 shock 130 J 3 and all subsequent shocks 180 J Recording of ambient noise voices 0 5 h ECG 0 5 h events 500 on 10 MB PCMCIA card includes 10 MB card Multimedia system to read and analyze the data stored on the PCMCIA card includes multimedia PC 17 monitor modem PCMCIA card reader and SAED Reader Pro software Modem for transmission of data stored on the PCMCIA card READER2 software required to receive the data Intended Use Functional Description MODEMGSM SEMA 200 READERO READER1 READER2 GSM kit enables FRED equipped with BUFREC12 to transmit 12 lead ECGs SEMA200 software required to read the data Software for display and interpretation of the 12 lead ECG transmitted by FRED equipped with MODEMGSM and BUFREC12 minimum PC re quirements Pentium II 300 MHz Windows 95 98 or NT SAED Reader Light free software for transmission of the data stored ona PCMCIA card to a PC serial and PCMCIA and for viewing of the ECG Windows 95 98 and NT compatible Memory card reader software in cludes PCMCIA drive SAED Reader Pro software and hardware key to read and analyze the data stored on the PCMCIA card for PC which meets the following minimum re quirements Pentium II 300 MHz Windows 95 98 or NT S
32. d 3 Keyboard test Number of stored events PCMCIA card Pulse shape Device options Serial number of the device O O1 OO N CON Contrast Adjustment The contrast can be adjusted with the buttons Selecting the Language Setting Date and Time Refer to chapter 7 Defibrillator Setup for details on selecting the language and setting date and time Normally date and time are set at the factory If you correct the setting and the device still displays the wrong date and or time the internal battery is depleted and must be replaced by a service techni cian FRED Version 4 15 Semiautomatic Defibrillation 4 Semiautomatic Defibrillation 4 1 Defibrillator Application Guidelines Observe the following guidelines to ensure suc cessful and safe defibrillation Otherwise the lives of the patient the user and bystanders are in danger 16 Warning Delivering a defibrillation shock to a patient with normal heart rhythm may induce ven tricular fibrillation Position patients flat on a hard surface where they are electrically insulated The patient must not be allowed to come into contact with metal parts e g bed or litter to prevent un wanted pathways for the defibrillation current which may endanger the assistants For the same reason do not position the patient on wet ground rain accident in swimming pool Do not allow the defibrillation electrodes to come into contact with other electrodes or me
33. e Shock advised message the device will discharge the en ergy internally when it has identified the new rhythm If an electrode becomes disconnected dur ing ECG analysis the message Connect the electrodes will be displayed and the de vice stops analyzing The analysis must be restarted after application of the electrode If during analysis the impedance at one of the electrodes reaches an inadmissible value the message Check the electrodes will appear and the device suspends the analysis The analysis continues as soon as the high impedance is eliminated e Do not touch the patient any more and warn all those present e Press the red Analyse Shock button within the next 20 seconds to trigger the shock if you do not trigger the shock within this period the en ergy will be discharged internally and you will have to restart the analysis Danger Shock Hazard High voltage is present at the electrodes until the capacitor is completely dis charged During this period do not touch the electrodes or the patient After delivery of the shock the message Press for analysis returns After the 3 shock the device prompts you to check the pulse and if no pulse is present to perform cardiopulmonary resuscitation for 1 min ute Afterwards the device again prompts you to initiate ECG analysis and to deliver up to 3 shocks if ventricular fibrillation or tachycardia HR gt 180 B min persists F
34. e oxyhemoglobin absorbs less red light than re duced hemoglobin this method allows the sys tem to determine the oxygen saturation The SpO measuring system is activated and deactivated by connection and removal of the sensor lead FRED 96 SpO2 72 pulses bargraph CLLLLLLLLL peth S ogra photodetector Figure 6 4 Principle of operation Note The SpO signal input is a high insulation port and it is defibrillation proof type CF Warning Patient Safety Use only the sensors and probes listed in chapter 9 Order Information These probes ensure patient safety during defibrillation Application Tips Use only the probes listed in the Order Infor mation chapter Apply the probes as de scribed in their instructions for use Do not exert too much pressure when apply ing the probe to avoid erroneous readings and blistering Inadequate oxygen supply to the skin not heat causes blisters Be careful to ensure continued circulation at the probe site Change the probe site at least every 24 hours to allow the skin to breathe Incident light may cause inaccurate readings Cover the measuring site with a cloth if nec essary It may not be possible to measure SpO2 values if cardiac output is determined at the same time by means of the dye dilution tech nique It may not be possible to measure SpO values or the pulse rate if the circulation is impaired
35. e g by a blood pressure cuff or by an extremely high vascular resistance Remove nail varnish and artificial finger nails before applying the probe Both may lead to inaccurate readings Do not apply the finger probe to the same arm as the blood pressure cuff 28 FRED Version 4 Optional Device Features SoO2 Measuring System Probe Application Finger Probe e Insert the patient s forefinger into the probe as far as it will go Make sure that the finger tip pad covers the entire probe window This is to prevent that extraneous light reaches the photodetector Use the Y Universal Probe on patients with very long finger nails NN Figure 6 5 Finger probe Y Universal Probe for Adults Finger e Apply the light source of the probe on top of the finger nail Align the photodetector such that it is directly opposite the light source Carefully secure the probe and the lead with adhesive tape Do not wrap the tape too tight light source adhesive tape l Figure 6 6 Y universal probe Y Universal Probe for Infants Foot e Apply the sensor to a well perfused part of the foot with the light source in a top position to prevent that extraneous light reaches the photodetector Position the photodetector di rectly opposite the light source Carefully se cure the probe with adhesive tape Do not wrap the tape too tight adhesive tape light source Figure 6 7 Y universal probe applied to the
36. e sequence for the modem integrated in the cellular telephone transmission of the 12 standard ECG leads When you have entered the password the entry screen will appear Figure 7 4 PHONE 12 LEAD Figure 7 4 Screen for entry of the telephone numbers FRED Version 4 Defibrillator Setup At Type you can choose among four different entries CARD select to enter three different telephone numbers for transmis sion of the data from the PCMCIA card 12 LEAD select to enter three different telephone numbers for transmis sion of the ECG CARD Hayes select to enter the initialization 12 LEAD Hayes sequence for the PCMCIA modem required only if the default se quence does not work select to enter the initialization sequence for the cell phone modem required only if the de fault sequence does not work Entering the Telephone Number Using amp or amp select either CARD or 12 LEAD Use to move the cursor to the position for entry of the first digit or to the position whose digit you want to change Using 8 or R choose the digit you want to enter The comma sign is used to enter a pause required to access the outside line The red Analyse Shock button is used to delete the entire telephone number When you have entered the full telephone number position the cursor on Type and press the red Analyse Shock button to quit the function Entering
37. eneral Information The product FRED bears the CE mark CE 0459 indicating its compliance with the provisions of the Council Directive 93 42 EEC about medical devices and fulfills the essential requirements of Annex 1 of this directive The product complies with the electromagnetic immunity requirements of standard IEC 60601 1 2 EN 60601 1 2 Electromagnetic Compatibil ity Medical Electrical Equipment The radio interference emitted by this device is within the limits specified in the standards CISPR11 EN 55011 class B The information given in this manual reflects software version 4 The manual is an integral part of the device and should always be kept near the device Close observance of the infor mation given in the manual is a prerequisite for proper device performance and correct opera tion and ensures patient and operator safety Therefore be sure to read the complete manual To ensure patient safety the specified measur ing accuracy and interference free operation we recommend using only original SCHILLER accessories The user is responsible if accesso ries from other manufacturers are used with the device The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers SCHILLER is responsible for the effects on safety reliability and performance of the de vice only if assembly operations extensions readjust ments modifications
38. ent 11 Automatic performance test 14 Averaging time SpO2 adjust 40 B Bar graph seine Mundi oo 31 Basic product version 5 Battery Charging eeseeesseeeeesneeeeeeeneeereseeeerenaeeeeeed 12 Biocompaltibility ee eeeeeeeeneeeeeeseeeeeneeeeeeeneeerenaees 5 C Caution definitionen aee ai 4 Chain of survival 5 Changing the language 40 Charge times vic hit miennes 44 Charging unit 12 Charging unit DG 2002 C2 12 Checks at regular intervals 26 CIC ANING P ere Fan heart 25 Contrast adjustment 15 D Danger definition 4 Data transfer PCMCIA card 35 Data transfer via modem 35 Date anditime i 3sssss tir es 15 Date format Date enter Defibrillation electrodes application eee 19 Defibrillation Of children 34 Defibrillation manual cceeeeeceeeceeeeeeeseeeeeeeeeees 33 Defibrillation semiautomatic mode 19 Defibrillator application guidelines Device labeling relevant for safety Discharge curve Disinfect Nrs eun eaen ne mienne Disposal at the end of its service life 26 E ar probe sim dati aide Nac 30 EGG display s siccacc cies dike tdi diet 27 ECG electrode application 27 ECG transmission 37 Electromagnetic imm
39. essage Press for analysis appears and the indicators of the red Analyse Shock button start blinking green e Do not touch the patient any more and warn all those present e Now press the red Analyse Shock button to initiate ECG analysis The message Analysis in progress do not touch the patient appears Figure 4 5 The analysis takes approx 9 seconds The following operating steps depend on whether or not the device identifies a shockable rhythm Device identifies a shockable rhythm When the analysis program detects ventricular fibrillation or ventricular tachycardia with a rate greater than 180 B min you will see the message Shock advised stay away and defibrillator charging begins Figure 4 6 You can watch the energy charging process by looking at the bar diagram The device will charge to the factory set energy levels defibrillator delivering biphasic shocks 1 shock 130 J or 90 J 2 shock 130 J 3 and all subsequent shocks 180 J defibrillator delivering monophasic shocks 1 shock 200 J 2 shock 200 J or 300 J 3 and all subsequent shocks 360 J When the selected energy is charged the device emits an audio signal the message Stay away shock appears the indicators in the red Analyse Shock button start blinking red 20 FRED Version 4 Semiautomatic Defibrillation Note If the heart rhythm changes to a non shockable rhythm after th
40. foot Y Universal Probe for Infants Hand e Apply the sensor to a well perfused part of the hand with the light source in a top position to prevent that extraneous light reaches the photodetector Position the photodetector di rectly opposite the light source Carefully se cure the probe with adhesive tape Do not wrap the tape too tight adhesive tape light source Figure 6 8 Y universal probe applied to the hand FRED Version 4 29 Optional Device Features SoO2 Measuring System Wrap Around Sensor for Children Toes e Apply the sensor to the child s toe with the light source on the toe nail to prevent extrane ous light from reaching the photodetector Again position the photodetector directly op posite the light source Carefully secure the probe and the lead with adhesive tape Be careful not to exert too much pressure with the tape adhesive tape light source Figure 6 9 Wrap around sensor for children applied to the toe Wrap Around Sensor for Neonates Foot e Apply the wrap around sensor for neonates to a well perfused part of the foot with the light source in a top position to prevent that extra neous light reaches the photodetector Posi tion the photodetector directly opposite the light source Carefully secure the probe with adhesive tape Do not wrap the tape too tight adhesive tape light source Figure 6 10 Wrap around sensor for neonates applied to the foot Ear Pr
41. ition performance test In particular the cables connectors elec trodes as well as sensors and probes must be checked for signs of damage Damaged parts must be replaced immedi ately before use Ensure that there are no conductive con nections between the patient and bystand ers during defibrillation Devices may be connected to other devices or to parts of systems only when it has been made certain that there is no danger to the patient the operators or the envi ronment as a result In those instances where there is any ele ment of doubt concerning the safety of connected devices the user must contact the manufacturers concerned or other in formed experts as to whether there is any possible danger to the patient the operator or the environment as a result of the pro posed combination of devices Standards IEC 60601 1 1 EN60601 1 1 must be com plied with in all cases FRED Version 4 Putting the Device into Operation and Performance Test The device is suitable for application in a humid environment provided the regula tions concerning drip proof equipment of IEC 60601 EN 60601 are strictly observed However do not defibrillate patients in a very moist or wet environment unless ab solutely necessary While connected to the charging unit FRED must not be used outdoors Warning Equipment Failure Magnetic and electri cal fields are capable of interfering with the proper performance of
42. lar telephone with integrated Hayes compatible modem and serial RS232 interface Figure 6 24 Port for cellular telephone In the setup menu chapter 7 Defibrillator Setup you can enter 3 telephone numbers different from those for data from the PCMCIA card which the device will dial automatically If the first number is busy FRED will try the sec ond number if this number is also busy the third number will be used An error message will be displayed when the communication link cannot be established Transmitting Data The data transmission takes about 3 minutes e Turn off FRED and connect the cellular telephone to the serial interface Figure 6 24 10 SEC ECG RECORDING f e Turn on the cellular telephone alls Aly Alls NG Ae Y e Apply the ECG electrodes as described in 83sm section 6 3 and connect them to the device using a 10 lead patient cable e Turn on FRED PRESS FOR ANALYSIS e When FRED is in normal mode press the Figure 6 25 Recorded ECG segment C button FRED will now acquire the ECG for a period of 10 seconds all 12 standard leads simultane ously Figure 6 25 At the same time FRED dials the telephone number s FRED Version 4 37 Optional Device Features Transmission of the 12 Lead ECG 0694548367 Job Nh Som PRESS FOR ANALYSIS Figure 6 26 Number called 00 24 S0 Fa 66 EER EE
43. layed Figure 6 17 the device emits an audio signal the indicators of the red Analyse Shock button start blinking red e Now trigger the shock within the next 20 seconds by pushing the red Analyse Shock button e Check the patient s ECG e End the therapy as described in chapter 4 34 FRED Version 4 Optional Device Features Transferring Data from PCMCIA Card 6 5 Transferring Data from a PCMCIA Card i battery Figure 6 18 Modem port ADJUST CONTRAST CONTROL PRESS PHONE KEY TO CONTINUE Figure 6 19 Power on display TRANSMISSION CARD ERASE CARD ERASE INFORMATION PHONE Next PLUS MINUS Select Figure 6 20 Menu Caution ECG analysis is not possible while the ECG is being transferred Therefore the device should not be connected to the patient any more Some Basic Facts This option allows you to transfer all data stored on the PCMCIA card to a PC either via modem or directly via a data cable null modem cable For the transfer you need either a Hayes compatible modem model V90 56 K or a null modem cable The setup menu chapter 7 Defibrillator Setup allows you to enter 3 telephone numbers which the device dials automatically If the first number is busy FRED will try the second number if this number is also busy the third number will be used If the communication link cannot be established an error message will be dis
44. ls in semi automatic mode delivered into 50 ohms 200 200 360 Joules or 200 300 360 Joules e Error 15 or 2J e Capacitor charge time with full rechargeable battery after 15 shocks at 180 Joules 8s voltage V 4000 1 al le a ae Pe eee ee eee ee ee OQ an Poot 2 90Q a 3000 1 3 mao J EST a 50 0 2000 poop 5s 3007 1000 HUTT PA EE LEE Bead See 1000 ace PP PRE PES Do0 DEAE Se a ea S E o a 2 3 4 5 6 7 8 9 0 11 2 13 time ms Figure 8 1 Discharge curves at 180 Joules biphasic 20 Operating modes semiautomatic defibrillation synchronized defibrillation non synchronized defibrillation Synchronization shock released 20 ms after R wave Energy indication indication of the selected and charged energy on the display audible and visual charge done indication Energy selection automatic or manual with buttons Safety discharge 20s after charging if battery charge level is insufficient if device is defective 160 ms after shock when device is turned off Defibrillation electrodes disposable adhesive defibrillation electrodes pads Connection for defibrillation electrodes type BF 2 4 6 8 10 12
45. obe for Adults e To increase the perfusion in the ear lobe rub it for 1 to 2 minutes to increase the effect you may apply a 70 percent concentration of isopropyl alcohol As an alternative you can use a vasodilating cream Attach the probe to the ear lobe with the light source on the outer side hooking the bow onto the ear if desired stabilizer light source Figure 6 11 Ear probe 30 FRED Version 4 Optional Device Features SpO2 Measuring System 00 24 S 0 25 phd dp a2 DR Sg SEE Figure 6 12 SpO window on the display semi automatic mode ECG Display op tion installed 00 24 S 0 F25 Adda pl Te coh SEN Se EEN hs 130 J Figure 6 13 SpO window on the display manual mode Displaying the Plethysmogram SpO Value and Bar Graph e Apply the probe as described above and connect the lead to connector 3 blue e After approx 8 seconds you will see the plethysmogram the SpO value and the bar graph indicating the signal strength on the display Figure 6 12 This window will also show any SpO related system messages Messages referring to the operation of the defi brillator e g Press for analysis have a higher priority and will therefore briefly hide the SpO window In the manual mode the display also indicates the selected defibrillation energy below the SpO2 value Figure 6 13 Note The plethysmogram ampli
46. played not required if a null modem cable is used It takes about 10 to 15 minutes to transfer the data of a full 2 MB card and about 50 minutes for a full 10 MB card e Turn off FRED and connect either the modem or the null modem cable to the modem port Figure 6 18 e Either connect the modem to the power line and telephone network or connect the null modem cable to the PC e Turn onthe modem e Simultaneously press C and On Off to turn on FRED The display shown in Figure 6 19 will appear Now you can adjust the contrast The contrast cannot be adjusted later because the contrast buttons are needed to control the device during data transfer e Press the button A menu Figure 6 20 with the following options appears transmission transmission card erase card erase information displays information about the last data transfer session FRED Version 4 35 Optional Device Features Transferring Data from PCMCIA Card TRANSMISSION 2 0694548367 CALL PHONE NUMBER Figure 6 21 Call phone number display TRANSMISSION 2 0694548367 TRANSMISSION PROGRESS 07 00 01 04 Figure 6 22 Data transmission INFORMATION START 20 12 2000 11 51 DURATION 00 01 TRANSMISSION ERROR CARD ERASE PHONE UNOBTAINABLE ANALYSE EXIT Figure 6 23 Information about the data transmis sion session Transmitting Data e Using the button select menu item Trans
47. pprox 2 s to turn device off 15 Connection for charging unit 16 Charging indicator is illuminated when voltage to charge the NiCd battery is applied at connector 15 17 Serial interface modem connection 18 Slot for PCMCIA card top the slot below is reserved for future use do NOT use for PCMCIA card 19 Eject button for PCMCIA card fold out and push 20 Rechargeable NiCd battery or lithium battery FRED Version 4 Controls and Indicators Explanation of Symbols Symbols used on the Device and on the Battery Type CF signal input suitable for intracardiac application defibrillation proof Symbols used on the Display Time elapsed since device was turned on minutes seconds Type BF signal input defibrillation proof Number of shocks delivered since device was turned on Caution High Voltage Battery low ECG signal input Data storage on PCMCIA card Sas amp Refer to user manual initiation of defibrillator charging manual opera tion Data storage problem QRS blip Contrast adjustment Physician button enabling the manual operating mode en gt 2 i wo ECG transmission via cellular tele phone increasing energy level decreasing energy level data transmission via modem product is recyclable do not dispose of with household waste do not recharge do not short
48. r influ ence on the life and capacity of lithium batter ies At a constant temperature of 20 C the following ratings can be expected new battery 450 shocks at 180 Joules or 5 hours of monitoring battery inside device for 1 year 150 shocks at 180 Joules or 2 hours of moni toring battery inside device for 2 years 70 shocks at 180 Joules or 1 hour of monitoring battery inside device for 2 5 years 50 shocks at 180 Joules or 45 minutes of mo nitoring Avoid releasing the stored energy in a rapid or uncontrolled manner e g by shorting termi nals together Do not incinerate lithium batter ies or expose them to high temperatures do not crush open or dismantle them Do not use deformed or punctured lithium batteries Warranty Information SCHILLER warrants lithium batteries for a pe riod of 6 months to be free from manufacturing faults The warranty period begins on the ship ping date annotated on the battery A seal guar antees that the battery is new and unused Re move or break this seal immediately prior to inserting the battery SCHILLER assumes no liability for improper handling or reduced capac ity as a result of battery usage FRED Version 4 13 Putting the Device into Operation and Performance Test 3 3 Turning the Device On and Testing Its Performance Some Basic Facts FRED is turned on and off with the On Off button To turn the defibrillator off the On Off
49. s FRED Version 4 Identification of respiratory and cardiac arrest Notification of emergency medical facility Immediate institution of CPR Early defibrillation if indicated ar D Advanced treatment by emergency physician without delay 6 Transfer to an ICU The following persons are involved in the chain e witnesses e first responders and bystanders e emergency medical staff emergency physi cian e hospital staff A break anywhere in the chain can compromise the efficiency of the entire chain Biocompatibility The parts of the product described in this man ual including all accessories that come in con tact with the patient during the intended use fulfill the biocompatibility requirements of the applicable standards If you have questions in this matter please contact SCHILLER Intended Use Functional Description 1 2 Functional Description FRED is a compact battery powered semiauto BUFRDI matic defibrillator basic model The patient is defibrillated via disposable adhesive pads which also acquire the ECG signal for analysis BUFRS and for determination of the heart rate The device prompts the user by text and audio messages display speaker BUFREC3 For documentation purposes the ECG 5 hours max and the intervention 500 events max are saved to a PCMCIA card The device can be powered from a slot in re BUFREC12 chargeable NiCd battery or from a slot in lithium battery
50. t and it can be increased to 4 J kg body weight for subsequent shocks Risk of Skin Burns Owing to the high cur rents there is a risk of skin burns Note Depending on the clinical picture defibrillation may not be successful FRED Version 4 Semiautomatic Defibrillation 4 2 Safety Information for the Use of a Semiautomatic Defibrillator In addition to the guidelines set forth in section 4 1 the following rules must be observed when using a semiautomatic defibrillator Failure to do so may compromise the success of the defibrillation or endanger the patient s life Warning Semiautomatic defibrillation is only permit ted for patients with a body weight greater than 25 kg who are unconscious have ceased to breathe and are pulseless During ECG analysis suspend CPR ensure that the patient does not move do not touch the patient Otherwise artifacts may lead to incorrect analysis results In unfavorable situations the analysis of the ECG may occasionally be incorrect There fore the user is obliged to make certain that the conditions for use of a semiautomatic de fibrillator are met unconsciousness no respiration no pulse For the same reason the user is entirely re sponsible for delivery of the defibrillation shock Do not use the anterior posterior electrode placement for semiautomatic defibrillation Only specially trained staff authorized by the supervising
51. tal parts which are in contact with the pa tient The patient s chest must be dry because moisture can cause unwanted pathways for the defibrillation current When using flammable skin cleansing agents wait until they have completely dried The operator and all assistants must be briefed regarding the preparations for and execution of defibrillation All tasks must be clearly assigned Immediately prior to the shock cardiac massage and ventilation must be interrupted and bystanders must be warned Ensure that there are no conductive connec tions between the patient and other persons during defibrillation Warning Pacemaker Patients Defibrillating a patient with an implanted pacemaker is likely to im pair the pacemaker function or cause dam age to the pacemaker For this reason do not apply the defibrillation electrodes in the vicinity of the pacemaker have an external pacemaker at hand verify the pacemaker for proper functioning as soon as possible after the defibrillation Damage to Myocardium Please note that children require less energy for successful ventricular defibrillation than adults For the first biphasic defibrillation shock delivered to babies and small children select an energy of approx 1 J kg body weight For subse quent shocks the energy may be increased to 2 or 3 J kg body weight When using the monophasic device the energy for the first shock should be approx 2 J kg body weigh
52. ter that minute the message Check the pulse If no pulse 3 minutes CPR is displayed The message Check the pulse If no pulse 1 minute CPR will also appear when the ECG signal quality is insufficient for a cor rect analysis 22 FRED Version 4 Semiautomatic Defibrillation Internal Safety Discharge Ending Therapy A safety circuit ensures that the stored defibrillation e Turn off the device after therapy push On Off energy is discharged internally if the shock is not DES button for approx 2 seconds correctly delivered This situation exists when e Disconnect the electrode lead the shock is not delivered within 20 seconds of defibrillator charging audio signal there is an electrode problem the battery voltage is insufficient e Carefully remove the pads from the patient s skin Figure 4 8 and discard them immediately hospital waste to prevent that they are reused the device is defective you select a lower energy value in manual mode after charging you turn the device off correct Warning Patient Hazard If the device behavior differs Figure 4 8 Removing the pads from the description given in this manual the defibrillator is defective and must be repaired FRED Version 4 23 Semiautomatic Defibrillation Figure 4 9 Slot for PCMCIA card Overview of events documented with date
53. the device For this reason make sure that all external devices operated in the vicinity of the defibrillator comply with the relevant EMC require ments X ray equipment MRI devices ra dio systems and cellular telephones are possible sources of interference as they may emit higher levels of electromagnetic radiation Keep the system away from these devices and verify its performance before use Equipment Failure Similarly the defibril lator may disturb equipment operating in its vicinity when charging or delivering the shock Verify the performance of these de vices before use Operational readiness FRED is an emergency device and must be ready for operation at any time and in all situations Ensure that the rechargeable battery is always fully charged Suffocation Hazard Dispose of the packaging material observing the applica ble waste control regulations Keep the packaging material out of children s reach FRED Version 4 Caution Equipment Damage Exercise great care when using HF surgery equipment on the patient at the same as the defibrillator As a general rule a minimum distance between the ECG and defibrillation electrodes and the HF surgery electrodes of 15 cm must be ensured If this is not possible discon nect the electrodes and transducer leads while using the HF surgery device Equipment Damage Avoid triggering shocks repeatedly when electrodes are not applied because the devi
54. tient 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 In this situation check the patient s pulse again and restart the analysis The responsible physician is required to determine the algorithms for the first responders in accor dance with AHA or ERC or with local regulations Equipment Models and User Groups Basic Model The basic version of FRED is a semiautomatic defibrillator as required by the laws in most coun tries where semiautomatic defibrillation by EMTs is permitted The device also meets the AHA and ERC requirements Expanded Basic Model The use of a device expanded with options such as additional ECG signal input for patient cable and separate ECG electrodes SpOs measuring system is permitted only if the local laws authorize its application the supervising physician expressly approves its application the staff is trained accordingly Model convertible to manual defibrillation EMTs are not permitted to use this model if local laws authorize EMTs to employ only semiautomatic defibrillators without further explanations In some countries however EMTs and the super vising physicians demand that defibrillators be pushbutton convertible from semiautomatic to manual operation In these cases individual proto cols must be determined in cooperation
55. tude is not an indicator of signal quality because the system automatically amplifies small am plitudes Watch the bar graph and check that the plethysmogram is physiological in shape If an ECG signal is not available the pulse rate will be indicated instead of the heart rate The heart symbol blinking with each QRS complex will be replaced by the letter S Caution False Parameter Reading Patient Safety To ensure correct SpO readings the bar graph must never indicate less than 2 3 of the display range FRED Version 4 31 Optional Device Features Manual Operation 6 4 Manual Operation Figure 6 14 Buttons for manual operation of the device 11 Physician button to enable the manual mode 12 Button to increase the defibrillation energy 13 Button to decrease the defibrillation energy 14 Button to initiate defibrillator charging ANALYSIS KEY CHARGE KEY SELECTED ENERGY 130 J Figure 6 15 Manual mode display Enabling the Manual Mode Figure 6 14 shows the additional buttons on devices for manual defibrillation Warning Patient Hazard Only a physician is allowed to enable the manual mode Observe the information given in sections 4 1 4 2 and 4 3 e To enable the manual mode press the button and confirm the displayed message by pressing the button again Figure 6 15 shows the display of a device operat ing in the manual mode Note It is not possible to en
56. u choose you can connect a 3 lead 4 lead or 10 lead patient cable to connector 4 green If the device receives two ECG signals both from the pads and from the ECG elec trodes the signal acquired with the pads always has priority Only when this ECG signal is not available or disturbed will the device use the ECG signal acquired with the ECG electrodes Also the device will always choose the ECG lead that provides the best signal quality Warning False Alarms Use only silver silver chlo ride electrodes These electrodes prevent polarization voltages which may simulate cardiac arrest Note The ECG signal input is a high insulation port and it is defibrillation proof type CF FRED Version 4 27 Optional Device Features SoO2 Measuring System 6 3 SpO Measuring System Some Basic Facts The SpO measuring system measures and monitors the oxygen saturation of hemoglobin in the arterial blood and supplies the plethys mogram signal channel 2 The system measures arterial oxygen saturation by a method called pulse oximetry This method is based on the measurement of the different absorption spectra of reduced hemoglobin and oxyhemoglobin Therefore the probes consist of an IR light source on one side 2 LEDs anda photodetector on the other side which collects the incident light After penetrating through the tissue and blood the radiation from the LEDs causes an electrical signal in the photodetector Sinc
57. unity requirements 4 EMC requirements 11 Energy charging process ceeeesseeesseeeeeeneeeeeees 20 Energy levels tds 34 Energy selection manual 33 Environment serrer on ia tila ed 44 Erasing data on the PCMCIA card 36 European Resuscitation Council 5 Events OVErVICW ceeeecccccececeesseceeeeeteaeeeeeeeeeeeeeees 24 Explosion hazard 10 FRED Version 4 F Factory defauts i napriend tentent 40 Factory defaults restore ccceeeeeeeeeeeeeeeeeeetes 40 Fibrillation flutter detection 40 Finger probe sisia raaa anaa 29 First time operation 11 Frequency of the AC line filter 40 Functional description 6 G General information 4 H Hayes sequence eeseceeeeseeceeeseeeesensneeeteseeeeeteeeeers 41 HF surgery equipment 11 l Impaired device functions 26 Initialization sequence enter 41 Integration time SpOz adjust 40 Intended USE israel A ardh 5 Internal safety discharge 23 L Language Change seseesesriessrieerrrrerrirrsrrirserrreee 40 Lithium battery ccecccecceeeeeeeeneeeeeeeeeeseeesneeeees 6 44 M Manual defibrillation 18 3
58. ven the defibrillation command by pressing the appro priate button the device will wait for the next QRS complex to derive the trigger signal for actual delivery of the shock Caution No Shock In the synchronized mode the shock button must be held depressed until the shock has been delivered e Apply the pads as shown in Figure 6 16 STERNUM right sternal edge at the level of the 2nd intercostal space APEX left axillary line at the level of the 5 intercostal space also observe the informa tion given in section 4 4 Defibrillating a Pa tient in the Semiautomatic Mode l o P SSS coy _ Figure 6 16 Pad application points e Do not touch the patient any more and press the red Analyse Shock button to initiate ECG analysis e When the analysis program detects ventricular fibrillation or ventricular tachycardia with a rate greater than 180 B min you will see the message Shock advised stay away e Now select the required defibrillation energy with the buttons A and V The energy required for successful ventricular defibrillation depends on your patient s age thickness of the tissue and constitution FRED Version 4 33 Optional Device Features Manual Operation 2300 24 S0 o25 DEFIBRILLATOR READY 130 J Figure 6 17 Defibrillator ready Warning Even if the analysis program does not rec ommend
59. with the EMTs These will be based on the AHA or ERC protocols or on the respective local regulations Furthermore the emergency service is required to ensure that the agreed algorithms are observed the staff is trained accordingly the correct use of the device is verified after each intervention 18 FRED Version 4 Semiautomatic Defibrillation 4 4 Defibrillating a Patient in the Semiautomatic Mode ana 00 24 0 F3 CONNECT THE ELECTRODES Figure 4 1 Standard display 1 Time since device was turned on minutes seconds 2 Number of shocks delivered since device was turned on not reset to zero when battery replacement is completed within 5 minutes 3 Data storage on PCMCIA card enabled percentage value amount of memory used recorded ECG BMN CONNECT THE ELECTRODES Figure 4 2 Standard display with presentation of the ECG option 4 Baseline ECG 5 Heart rate e Switch on the defibrillator with the On off button After the test the standard display Figure 4 1 or 4 2 if device is equipped with the ECG Display option appears and you will be prompted to connect the electrodes In addition the defibrillation pad indicator 6 Figure 2 1 blinks and the device emits an alarm tone e Apply the pads as shown in Figure 4 3 STERNUM right sternal edge at the level of the 2nd intercostal space APEX left axillary line at the level of the 5 jn tercostal space
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