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Schiller FRED easy, Руководство пользователя

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 Page 81

Technical Data

8

User Guide

System Specifications

8.1

A

rt.

 no.

: 0-4

8

-00

13 Rev. m

FRED easy

8 Technical Data

8.1

System Specifications

Unless otherwise stated, all specifications are valid at a temperature of 25 °C.

Manufactured by

SCHILLER MEDICAL

Device name

FRED easy®

 

Dimensions

SD card version
Ethernet/Online Versions

70 x 230 x 220 mm (h x l x w)
70 x 237 x 220 mm (h x l x w)

Weight

Approx. 1.5 kg

Protection class of the device 
housing 

IP54 (protection against dust and splashing water)

Recorded data

ECG signal recording (2 hours)
Ambient noise recording (2 hours)
Event recording (500 events)

Power supply

Standard battery type

Battery life

Optional battery type

  

Battery life

Internal power supply, suitable for continuous operation with intermittent loading

Lithium/MnO

2

 12 V, 2.8 Ah

• 180 shocks at maximum energy, or 3.75 hours of operating (alternately 

30 minutes ON and 30 minutes OFF)

• Several years in standby (standby duration corresponding to laboratory tests at 25°C: 5

years with weekly self-tests)

NiCd 12 V, 650 mAh, rechargeable
• 45 shocks at maximum energy, or operating for 1 h 20 min.

Environmental conditions

a

Device

Operation
Storage befor use 

Storage and transport 

Battery and Electrodes

Storage and Transport temper-
ature battery LiMnO

2

Storage and transport temper-
ature electrode pads

a.

For additional information about operating and storage conditions see page 

67

 Chapter 

6.5

 

Special operating conditions

.

• -5...40 °C at a relative humidity of 30 to 95% (no condensation)
• -5...40 °C with the battery inserted and incl. electrodes at a relative humidity of 30

to 95 % (no condensation) but resulting in a reduced battery life; optimal condi-
tions: 15...25 °C to ensure maximum battery life.

• Atmospheric pressure 700 to 1060 hPa
• -20 ... 50 °C at a relative humidity of 0 to 95% (no condensation)
• Atmospheric pressure 500 to 1060 hPa

• 0 ... 60 °C (48h max. between 0...15 °C and 25°...60°C)

• 0 ... 50 °C

Содержание FRED easy

Страница 1: ...FRED easy User Guide Automated external defibrillator AED FRED easy SD Card Ethernet Online Life Art no 0 48 0013 Rev m 0 48 0013 ...

Страница 2: ...341 Baar Switzerland E mail sales schiller ch Web www schiller ch Sales and service information The SCHILLER sales and service centre network is world wide For the address of your local distributor contact your nearest SCHILLER subsidiary In case of difficulty a complete list of all distributors and subsidiaries is provided on our internet site http www schiller ch Sales information can also be ob...

Страница 3: ... 2 Symbols used on the device 10 1 10 3 Symbols used on the battery 11 1 10 4 Symbols used on the electrode packaging 12 2 Components and Operation 13 2 1 General Information 13 2 2 Design 14 2 3 Function 16 2 3 1 Overview on the configurable settings 17 2 4 Operating and Display Elements 18 2 4 1 Overview on versions and operating modes 18 2 4 2 Operation and display 20 2 4 3 Display 21 2 4 4 Sym...

Страница 4: ... Internal safety discharge 47 4 8 Finishing the therapy 47 5 Versions 48 5 1 SD card version 48 5 1 1 Inserting the SD card 49 5 2 Ethernet version 50 5 2 1 Connecting the Ethernet adapter 50 5 2 2 Data transmission procedure 51 5 2 3 Installing the ferrite core 53 5 3 Online version 54 5 3 1 Ensuring data transmission 55 5 3 2 Placing the FRED easy in the docking station 56 5 3 3 Activating the m...

Страница 5: ... 4 3 Disposal at the end of its useful life 72 7 5 Trouble Shooting 73 7 5 1 Error messages 73 7 5 2 Transmission error Ethernet Online FRED easy 75 7 5 3 Trouble Shooting 78 7 5 4 Measures to prevent electromagnetic interferences 80 8 Technical Data 81 8 1 System Specifications 81 8 2 Classification and safety standards 82 8 3 Defibrillation pulse 83 8 4 Electromagnetic interferences 85 8 4 1 Ele...

Страница 6: ...Page 4 FRED easy Art no 0 48 0013 Rev m ...

Страница 7: ...equired are country specific In any case legal regulations have to be observed Before using the device a SCHILLER representative must perform a presenta tion on the device s operation and safety measures if it s required by the local regulations The indications given by this equipment are not a substitute for the regular checking of vital functions The numerical and graphical results as well as an...

Страница 8: ...t be used if the patient is responsive is breathing has pulse The FRED easy is an emergency device and must be ready for operation at any time and in all situations Make sure that the device is always equipped with a sufficiently charged battery and that a spare battery is at hand An empty battery must not be reused and must be disposed of immediately Only operate the device in accordance with the...

Страница 9: ... defibrillate the patient in a puddle of water or on other conducting surfac es switch the device off when it is no longer used Danger of explosion The device must not be used in areas where there is any danger of explosion There might be a danger of explosion in areas where flammable products petrol flammable anaesthetic agents or products for skin cleaning disinfection are in use or where the am...

Страница 10: ...y of a mains network with a frequency of 16 7 Hz railway lines in some countries FRED easy is not intended to be operated while using high frequency surgical devices Interference with other devices The charging of energy and the release of the defibrillation impulse can disturb other devices Check these devices before their further use Sensors and devices that are not defibrillation proof must be ...

Страница 11: ... subsequent damage is excluded The warranty is void if unauthorised or unqualified persons at tempt to make repairs In case of a defect send the device to your dealer or directly to the manufacturer The manufacturer can only be held responsible for the safety reliability and performance of the apparatus and assume the warranty if assembly operations extensions readjustments modifications or repair...

Страница 12: ... direct danger which could lead to severe personal injury or death For a possibly dangerous situation which could lead to severe personal injury or to death For a possibly dangerous situation which could lead to personal injury This symbol is also used to indicate possible damage to property For general safety notes as listed in this section For electrical hazards warnings or precautionary measure...

Страница 13: ...ble Do not recharge Do not short circuit Do not incinerate Do not cut Do not crush Battery storage unlimited storage duration between 15 C and 25 C within the limit of the specified expiry date max 48 hours between 25 C and 60 C as well as between 15 C and 0 C Battery must not be disposed of in the household waste Observe the user guide Battery expiry date ...

Страница 14: ...he electrode packaging Peel off the protective foil Disposable item do not reuse Do not bend packing Storage temperature for the electrodes Expiry date of the electrodes An open package cannot be conserved more than one day Do not expose to sunlight Does not contain latex Do not expose to rain Do not use the electrodes if the packaging is damaged Consult the user guide ...

Страница 15: ...ites of operation for a FRED easy are much frequented places such as airports train stations shopping centres public swimming pools sport centres public institutions Local laws and regulations regarding the use of an AED differs from country to coun try While some countries allow laypersons to use AEDs without any special training other countries restrict the use of AEDs to EMTs or First Responder...

Страница 16: ... During the intervention data can therefore be saved including the analysed ECG data ambient noise and events see 5 1 SD card version 5 2 Ethernet version and 5 3 Online version Data transmission The FRED easy SD card version features a removable SD memory card facilitating data transmission to other devices For the Ethernet and Online versions data trans mission is performed via Ethernet network ...

Страница 17: ...rillation Metronome Rechargeable NiCd battery Silent mode Ethernet Metronome Rechargeable NiCd battery ECG display Switchover to manual defibrillation Metronome Rechargeable NiCd battery Silent mode Online Metronome ECG display Switchover to manual defibrillation Metronome Silent mode Patients with implanted pacemakers FRED easy features an electronic pacer pulse suppression algorithm and therefor...

Страница 18: ...icator stops blinking and an alarm message is displayed The acoustic alarm is issued until the battery is flat In addition the device performs a daily or weekly self test this setting must only be configured by service personnel authorised by Schiller the self test is announced with a beep If a problem is detected in the course of this self test an acoustic alarm is issued the green indicator stop...

Страница 19: ...ed to all users Configurable parameters by means of FREDCO Volume of language output Energy level for 1st 2nd and 3rd shock separate settings for adults and children Manual or automatic start of the ECG signal analysis only in semi automatic op eration Activation deactivation of the 16 7 Hz filter a Sound recording Yes No a Sound recording The owner needs to inform users that the device records am...

Страница 20: ...tional mode with option for switchover to manual mode Automatic operational mode Semi automatic operational mode with option for switchover to silent mode Online Ethernet version The Online Ethernet versions are available with the same operational modes as the SD card version semi automatic semi automatic with option for switchover to manual mode Automatic Silent mode FRED easy Online FRED easy On...

Страница 21: ...RED easy FRED easy Life FRED easy Life has got the same functions as the versions listed above the only ex ceptions are different printing on the foil not possible to switch to manual or silent mode SD card Online Ethernet version SD card semi automatic operation Online Ethernet SD card automatic operation ...

Страница 22: ...ot detected an acceptable resist ance between the electrodes i e when the electrodes are not applied and or the electrode cable is not connected 3 Port for the adhesive pads 4 Display 5 The green button has got the following functions Switch on the device press for max 1 second Switch the device off press and hold for 3 seconds Start the analysis in semi automatic mode only press the button for 1 ...

Страница 23: ... played on these 3 lines 2 4 4 Symbols used on the display DO NOT TOUCH THE PATIENT ANALYSING 1 2 Number of shocks delivered since the device was turned on Sufficient battery capacity see 3 1 Inserting the battery Low battery capacity see 3 1 Inserting the battery SD card detected percentage of memory used SD card not recognised see 5 1 SD card version Adult pads detected Paediatric pads detected ...

Страница 24: ...to chemicals that could dissolve ABS polypropylene polyvinyl chloride nickel mylar or steel Do not short circuit cut destroy burn or charge Li MnO2 battery a battery Patient hazard Incorrect battery capacity indication A new battery is initialised by the device when inserting it and is allocated to this device It must not be inserted in another device Replace the battery if the device indicates a ...

Страница 25: ... FRED easy TRAINER be cause its voltage is not suitable for this device Do not use the lithium battery to power the FRED easy TRAINER because its voltage is not adapted to this device Insert the battery as indicated in the illustration on the left Firmly press the battery into the battery compartment until it clicks into place As soon as the battery is inserted the FRED easy runs a self test to ch...

Страница 26: ...attery is low or depleted The lithium battery ensures that the device stays fully operative and performs the self test for several years at a temperature between 15 C and 25 C provided that the device is not being used Battery service life depends on device use and ambient conditions Whatever its remaining capacity the battery must be replaced once the expira tion date indicated on the packaging h...

Страница 27: ... below the low threshold while the device is in use the green indicator is turned off the symbol starts blinking on the display and the device emits an audible signal These warnings are issued until the battery is replaced or recharged The battery must be replaced as quickly as possible Fig 3 4 Low battery capacity Low battery capacity during self test or after the battery has been inserted If low...

Страница 28: ...d battery is detected The battery needs to be replaced immediately REPLACE BATTERY 30 CHEST COMPRESSIONS THEN 2 RESCUE BREATHS Depleted battery during self test When a depleted battery has been detected the green indicator is off and an au dible signal is emitted When the device is next switched on a message is displayed prompting the user to replace the battery and continue with CPR until the dev...

Страница 29: ...plied in the anterior anterior position With infants an terior posterior placement can be advised to prevent a short circuit between the two defibrillation electrodes A defibrillation can fail with certain disease patterns Before each use the user must verify that the device operates reliably and is in proper working order It is especially important to check that connection cables are not damaged ...

Страница 30: ...ety wipe off flammable skin cleansing agents The user and all assistants must be briefed regarding the defibrillation procedure preparation and execution The assistants tasks must be clearly defined During ECG analysis suspend CPR ensure that the patient lies as motionless as possible do not touch the patient otherwise artefacts may lead to incorrect analysis re sults Immediately prior to the shoc...

Страница 31: ...nd call the emergency medical service Once the device is turned on by pressing thre green button an instruction text reminds the user to call the emergency medical service Assess the patient s condition The device then prompts the user to assess the patient s condition Preparing the patient Once you made sure that the patient does not show any signs of circulation you are prompted to remove the cl...

Страница 32: ...es on the patient s chest The yellow indicator is lit and the device repeats the instructions twice until the electrodes are applied or until the electrode connector is connected to the device respectively and the electrode skin resistance impedance has reached an ac ceptable level After the second prompt to apply the electrodes the device recommends to per form a cardiopulmonary resuscitation cyc...

Страница 33: ...rwise artefacts may lead to an incorrect analysis The FRED easy includes a motion detection function When the ECG analysis is disturbed by CPR or patient movements the device informes the user via a voice prompt and a written message on the display The analysis is automatically resumed as soon as the cause of disturbance has been eliminated If no correct analysis has been obtained by the time the ...

Страница 34: ... cycle According to the configuration of the device a CPR cycle consists of performing chest compressions during the set period of time or performing alternatively 30 chest compressions and 2 breathes during the set period of time Before each CPR cycle the device informs the user that the patient can be touched The device indicates the position of the hands and the rhythm of chest compressions wit...

Страница 35: ...y SCHILLER s customer service see 8 Technical Data Successful shock followed by CPR After a successful shock no further shocks advised by the ECG analysis FRED easy prompts the user to perform CPR No shock advised The device has not detected a shockable rhythm If the analysis algorithm does not detect a shockable rhythm the FRED easy in forms the user that no shock is necessary and prompts him or ...

Страница 36: ...he pads up to their expiration date Please note that the expiration date of the pads only applies if the vacuum pack is intact The pads are sufficiently pre gelled Do not use extra contact agent Do not reuse the pads 1 2 3 Fig 4 1 Yellow indicator The yellow indicator is lit and the device repeats the instructions twice until the elec trodes are applied or until the electrode connector is connecte...

Страница 37: ...ent s chest Step 2 Connecting the electrode cable to the device Fig 4 3 Inserting the connector into the port Risks for the user and the patient The packaging of pre connected electrodes is welded to the electrode cable Do not remove the packaging from the elec trode cable risk of damaging the cable Pre connected electrodes which are already connected to the device only need to be applied to the p...

Страница 38: ...des 1 Before applying the adhesive electrodes verify that the application sites on the patient s chest are clean and dry 2 The skin must be cleaned by rubbing the application points vigorously with a dry cloth Do not use alcohol or alcohol wipes This could significantly increase the contact impedance between the electrodes and the skin 3 Carefully shave the application sites if the patient s chest...

Страница 39: ...e remaining contact agent off with a cloth 3 shave both application points to improve the contact between the electrodes and the skin 4 apply new defibrillation electrodes If the resistance impedance reaches an unacceptable value the device interrupts and prompts the user to check the electrode application and connection CHECK CONNECTOR IS FITTED AND ELECTRODE APPLIED ON CHEST In addition the yell...

Страница 40: ... 4 2 Defibrillation procedure 3 Connect the electrode cable to the device see 4 3 Applying the adhesive elec trodes 4 Apply the defibrillation electrodes to the patient s chest see 4 3 Applying the ad hesive electrodes Briefly press the green button max 1 second to start the analysis Otherwise the de vice will switch off The semi automatic version of the FRED easy can be configured so that the ECG...

Страница 41: ...or alternately performing 30 chest compressions and 2 breathes for the set period of time After the CPR cycle the device continues with Step 2 Analysing the ECG signal Finishing the therapy See 4 8 Finishing the therapy When the energy is charged the user is prompted to trigger the shock by pressing the lit orange button Shock hazard Do not under any circumstances touch the patient during shock de...

Страница 42: ...If a shock is advised the energy is automatically charged A countdown accompanies the last 3 seconds before the shock is delivered Risks for patient users and assistants Once the device has been switched on with the green button and the electrodes have been applied the ECG analysis is started automatically and a shock is delivered automatically if a shockable rhythm is present The user is informed...

Страница 43: ...to start analysis 1 Briefly press the green button max 1 second to switch on the device 2 Assess the patient s condition see 4 2 Defibrillation procedure 3 Connect the electrode cable to the device see 4 3 Applying the adhesive elec trodes 4 Apply the defibrillation electrodes to the patient s chest see 4 3 Applying the ad hesive electrodes If the device detects ventricular fibrillation or ventric...

Страница 44: ...ry resuscita tion Step 4 Performing cardiopulmonary resuscitation 5 Perform a CPR cycle According to the configuration of the device a CPR cycle consists of performing chest compressions for the period of time configured or performing alternatively 30 chest compressions and 2 breathes during the peri od of time configured After the CPR cycle the device proceeds with Step 2 Automatic ECG analysis F...

Страница 45: ...ode to manual mode is made available to EMTs and medical personnel non physicians In this sit uation individual protocols must be determined in cooperation with the EMTs These protocols must be based on AHA or ERC protocols or on the regulations of the country in question Furthermore the emergency service is required to ensure that the proce dures established are observed and that the staff is tra...

Страница 46: ...the electrode cable and apply the electrodes to the patient s chest see sec tion 4 3 Applying the adhesive electrodes The patient s ECG signal is automatically displayed when the FRED easy is switched to manual mode Defibrillator charging In manual defibrillation the energy values of the first 3 shocks are those defined for the semi automatic mode For all subsequent shocks the energy level of the ...

Страница 47: ...imultaneously pressing these same buttons a second time 3 Connect the electrode cable to the device 4 Apply the electrodes on the patient s upper body see 4 3 Applying the adhesive electrodes Step 2 Charging the energy 5 Briefly press the green button max 1 second Patient hazard Only a physician is allowed to enable manual mode Observe the instructions given in section 4 1 Instructions and Safety ...

Страница 48: ... semi automatic mode turn off the FRED easy and leave it turned off for at least 5 minutes before switching it on again As soon as the energy is charged the device prompts the user to deliver the shock by pressing the orange button The orange button remains lit until the shock is delivered Shock hazard Only deliver a shock when a shockable heart rhythm is present Do not under any circumstances tou...

Страница 49: ...e therapy has been completed press and hold the green button for approx 3 seconds Disconnect the electrode cable Carefully peel the pads off the patient s skin see Fig 4 13 Removing the adhesive pads Recycle the disposable pads immediately after use to keep them from being reused by mistake hospital waste Fig 4 13 Removing the adhesive pads If the device s behaviour differs from the description gi...

Страница 50: ...the device before inserting or removing the SD card Do not insert the Ethernet adapter into the SD card slot Malfunction hazard The SD card must only be used in one single device Before being used in another device the SD card must be reformated with the Schiller data viewing software otherwise the recorded information will be incor rect Only use SD cards supplied by SCHILLER Overview of recorded ...

Страница 51: ...d 4 Once the card is inserted close the rubber cover of the card slot If the symbol is not displayed even though the card has been inserted check that the card has been recommended by SCHILLER for the use in this type of device Inserting the SD card automatically activates the memory function and the symbol is displayed see Fig 5 2 SD card inserted Fig 5 2 SD card inserted The symbol starts blinki...

Страница 52: ... the symbol starts blinking and no more data can be stored Stored data will be cleared once it has been transmitted Trans mitted data can be viewed using LifeDataNet The memory card cannot be removed for the FRED easy Ethernet version All events transmitted by the device are listed on page 48 In order to protect other electrical devices from interference during data transmis sion a ferrite core mu...

Страница 53: ...server clock If the message MEMORY CARD EMPTY is displayed the device can be switched off and the Ethernet adapter can be removed If the device is not switched off by the user it switches off automatically after one minute If information is stored on the internal memory the transmission starts automatically and the percentage of data transmitted is displayed Once the transmission is finished the m...

Страница 54: ...ou can switch off the device and remove the Ethernet adapter MEMORY ERASING 25 The data stored on the internal memory is deleted once the transfer of the entire data record is completed If the transfer is interrupted data remains stored on the internal memory and the transfer can be restarted TRANSMISSION COMPLETE FRED easy automatically aborts the connection 5 minutes after the data transfer has ...

Страница 55: ...ore see Fig 5 6 Installing the cable within the ferrite core 2 Shut the ferrite core without closing it completely and check the cable position 3 Reduce the size of the loop to place the ferrite core as closely as possible to the Ethernet plug To do so pull the long end of the cable see Fig 5 7 Reducing the loop 4 Close the ferrite core see Fig 5 8 Correctly installed ferrite core Part No Descript...

Страница 56: ...the internal memory as well as detailed device configuration data to the LifeDa taNet web server It also allows a total remote control of the FRED easy using Life DataNet see table below Communication takes place via a network infrastructure using the SNMP Simple Net work Management Protocol communication protocol Fig 5 9 Online version with docking sta tion The SD card is not removable in the FRE...

Страница 57: ...e section 5 3 2 page 56 Only use lithium batteries with the Online version Do not use rechargeable NiCd batteries Do not remove the battery from the device while the device is inserted in the dock ing station Turn off the device before inserting it in the docking station Otherwise no data will be transmitted The user and installation handbook for the docking station part no 0 48 0156 pro vides fur...

Страница 58: ...cation indicator is blinking when the de vice is able to communicate with the data network The same screens are displayed as during data transmission with the Ethernet version see 5 2 2 Data transmission procedure Once all data has been transmitted the display illumination switches off and the mes sage FREDeasy Online READY is displayed This message is displayed whenever the device is able to comm...

Страница 59: ...s the buttons and The message MAINTE NANCE IN PROGRESS is displayed While in maintenance mode the device can be removed from the docking station for service purposes In this case the server recognises that the device was not removed for defibrillation purposes and does not generate any alarms After the device has been returned to the docking station maintenance mode must be switched off by again s...

Страница 60: ... FRED easy Ethernet version 5 IP address of the network mask depends on the network infrastructure 6 IP address of the network gateway depends on the network infrastructure 7 IP address of the domain name system depends on the network infrastructure 8 MAC address of the FRED easy Ethernet version located on the label on the underside of the device 9 IP address of the server s network interface use...

Страница 61: ...d password 11 can be freely changed but they must be the same as those specified in the SNMP Parameters tab of LifeDataNet see user manuel of LifeDataBox LifeDataNet 0 48 0117 By default the login is fredeasy and the password is schiller To apply any changes to the parameters click the Update button 12 Once the battery is inserted FRED easy Ethernet offers the option to manually configure the IP a...

Страница 62: ...RW Community password 3 Confirmation of Online tab configuration Enter the RO and the RW Community password 2 You can choose any pass word but it must be identical to the password entered in the FREDeasy section of the SNMP Parameters tab in LifeDataNet see Fig 5 15 SNMP parameter in LifeDataNet Fig 5 15 SNMP parameter in LifeDataNet Click the Update button 3 to apply any changes A password provid...

Страница 63: ...ss the green key to jump to the next value 5 Press the green button to jump to Apply and press the orange button to confirm and apply the changes When you have confirmed the values the menu disappears and the device can be switched on Date and time setting can also be done on non Ethernet Online devices if the pa rameter has been activated in FREDCO When the battery has been inserted a self test i...

Страница 64: ...s during CPR at 100 bpm The FREDCO software program allows you to set the metronome frequency to a value between 80 and 150 bpm in steps of 5 bpm the metronome can be set to signal to the user to give 2 rescue breaths the metronome is stopped for 8 seconds after 30 chest compressions PRESS GREEN BUTTON The ECG Display option is only available for the FRED easy semi automatic This option is automat...

Страница 65: ...an alternative a rechargeable NiCd battery 12 V 650 mAh is available for the defibrillator The capacity of a new fully charged battery is sufficient for 45 shocks at maximum energy or 40 minutes operating Like the lithium battery the device warns the user when the NiCd battery has reached the low battery threshold The device will still allow the user to perform defibrillation but the battery must ...

Страница 66: ...tient s cardiac rhythm without the user or patient being disturbed by the AED s repeated voice prompts If the device detects a change in the cardiac rhythm or if the green button is pressed silent mode is abandoned and voice prompts instruct the user about the next steps to be taken Moreover the heart rhythm is recorded and can be transmitted via network with the FRED easy Ethernet Online see 5 2 ...

Страница 67: ...d to continue with cardiopul monary resuscitation If the therapy has been successful and if the patient is responsive the device can be switched to silent mode Defibrillation is performed according to the safety notes in section 4 1 Instructions and Safety Notes and the procedure in section 4 4 Semi automatic defibrillation Switchover to silent mode can be done at the earliest after Step 2 as long...

Страница 68: ...automatically deleted after transmission Alternatively you can erase the memory during recording in silent mode as follows If the patient is no longer responsive i e loses consciousness immediately press the green button max 1 second to deactivate the silent mode and again start an analysis Step 2 The function Erasing memory without transferring the data is only available in silent mode Simultaneo...

Страница 69: ...ational readiness as well as maximum battery life Temperature 5 40 C Ensures operational readiness but reduces battery life This is compensated by spare batteries Ambient conditions for operation Temperature 5 40 C Operation is guaranteed if the storage conditions listed above are met for the storage before use If higher or lower temperatures prevail during use a limited operation time of up to on...

Страница 70: ... to the operating conditions on deck the following regulations apply If the patient is lying on a conducting surface e g metal floor in the engine or stor age room the patient needs to be positioned on an insulating mat prior to defibril lation Make sure that even the patient s arms and legs are positioned on the insulating mat ...

Страница 71: ... damaged cables must be replaced immediately FRED easy is an emergency device that must always be in proper working or der The device must be serviced on a regular basis The test results must be re corded and compared to the values in the accompanying documents see 9 5 Inspection report These checks and replacements can be performed within the framework of a main tenance contract by SCHILLER techn...

Страница 72: ...rised distributor Fig 7 1 Blinking green indicator If the device is defective or if problems have been detected by the device during the self test green indicator not blinking the device must be repaired before use Patient hazard If the device s behaviour differs from the description given in this user guide the device is defective and must be repaired In case of intensive use of the device SCHILL...

Страница 73: ...ives can be found on the SCHIL LER website www schiller ch In case of difficulty contact our head office in Switzer land Our staff will be pleased to help process your order or to provide details for all SCHILLER products Shock hazard Remove the battery before cleaning the device This ensures that the device will not be turned on inadvertently while you are cleaning it Risk of death Disconnect the...

Страница 74: ... Apart from the internal and plug in batteries the device does not contain hazardous material and can be recycled like any other piece of electronic equipment In accordance with national law the battery must be dis posed of at an appropriate waste disposal station or returned to SCHILLER According to European legislation this device is considered as electronic waste equipment It can be returned to...

Страница 75: ...inserting again Error message Possible cause Remedy xxx ADC EEPROM RTC LCD OKI DSP SHOCK BUTTON CHARGE DEFIBRILLATOR COMMUNICATION DEFIBRILLATOR 5 WEEKS CHARGE 150J Technical errors that may occur during function tests Switch the unit off and then on again to con firm If the message still appears the device must be repaired immediately xxx CPU DEFI CRC DEFI SAFETY DEFI REF VOLTAGE DEFI ADC DEFI DE...

Страница 76: ...unit off and then on again to con firm If the message still appears the device must be repaired The device was switching on while the orange and green button have been pressed Do not press the orange and green but ton while the device is switching on The device has detected a charge transistor error Switch the unit off and then on again to con firm If the message still appears the device must be r...

Страница 77: ...displayed re place the Ethernet adapter If the message still appears the device must be repaired The pads are connected to the device and are placed to the pa tient Disconnect the pads from the device Battery is empty Insert a new battery Device not used for more than 3 minutes Disconnect and reconnect the device to confirm If the message still appears the de vice must be repaired The device is no...

Страница 78: ...ata transmission Check the connection to the server and the network configuration then restart data transmission if the message is still dis played the device must be repaired Erroneous data transmission Check the connection to the server the net work configuration and the LifeDataNet configuration then restart data transmis sion if the message is still displayed the de vice must be repaired Erron...

Страница 79: ... and the LifeDataNet configuration then restart data transmis sion if the message is still displayed the de vice must be repaired The device is not able to con nect to the server Check the connection to the server the net work configuration and the LifeDataNet configuration then restart data transmis sion if the message is still displayed the de vice must be repaired Error message Cause Remedy TRA...

Страница 80: ...own on the pads Use new electrodes Use new electrodes Have the device repaired The device cannot be turned off On Off button was pressed less than 3 seconds Software hangs Device defective Hold down the on off button for at least 3 seconds Remove battery and inserting again Have the device repaired Incorrect analysis result e g the device does not detect a shockable rhythm even though the patient ...

Страница 81: ... and insert the card the right way around Switch the device off and insert the card the right way around Switch the device off and then on again Turn off the device remove the SD card unlock the write protection and re insert the card Then restart the de vice Have the device repaired Incorrect date and time stored on SD card Internal clock error Device defective Have the system parameters updated ...

Страница 82: ...cated below HF source Transmitter fre quency MHz Power P W Distance d m Radio telephone microcellular CT1 CT2 CT3 885 887 0 010 0 23 Cordless DECT telephone WLAN UMTS phone 1880 2500 0 25 1 17 Mobile phone USA 850 1900 0 6 1 8 Mobile phone GSM900 GSM850 NMT900 DCS 1800 900 850 900 1800 2 1 3 3 2 3 Walkie talkie rescue service police fire bri gade service 81 470 5 2 6 Mobile telephone system rescue...

Страница 83: ... operating alternately 30 minutes ON and 30 minutes OFF Several years in standby standby duration corresponding to laboratory tests at 25 C 5 years with weekly self tests NiCd 12 V 650 mAh rechargeable 45 shocks at maximum energy or operating for 1 h 20 min Environmental conditionsa Device Operation Storage befor use Storage and transport Battery and Electrodes Storage and Transport temper ature b...

Страница 84: ...ta Compliance FRED easy bears the Notified Body LNE G MED mark indicating its compliance with the provisions of the Directive 93 42 EEC modified by the Direc tive 2007 47 EEC regarding medical devices and fulfils the essential require ments of Annex I of this directive FRED easy is a class IIb device Patient Protection BF type resistant to defibrillation shocks Explosions protection FRED easy is n...

Страница 85: ... the default energy levels to the following values 1 2 4 6 8 15 30 50 70 90 110 130 150 J adults 1 2 4 6 8 15 30 50 70 J children automatic adaptation when paediatric pads are connected Cycle time rhythm analysis shock availability in semi auto matic mode With full battery After 15 discharges with max energy Maximum time between start of the analysis and shock availability in semi auto matic mode ...

Страница 86: ...ufficient The device is defective The device is turned off Defibrillation pad connection BF type Defibrillation electrodes Adult pads Paediatric pad Electrode cable 2 m in length 80 cm active surface 42 cm active surface VF VT detection Conditions for ECG analysis Shock recommendation VF VT detection is based only on the ECG signal Minimum amplitude for signals suitable for analysis 0 15 mV signal...

Страница 87: ...tic purposes Harmonics IEC 61000 3 2 Not applicable Voltage fluctuations IEC 61000 3 3 Not applicable Interference testing IEC 60601 test level Conformity level Electromagnetic environment explanations Electrostatic dis charge IEC 61000 4 2 6 kV contact 8 kV air IEC 60601 1 conformity Floors should be made of wood concrete or ceramic tiles If floors are covered with synthetic material relative hum...

Страница 88: ...be applicable Electromagnetic radiation is influenced by absorption and reflection on struc tures objects and people a The ISM frequency bands ISM industrial scientific medical between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The conformity levels within the ISM frequency bands between 150 kHz and 80 MHz and betwee...

Страница 89: ... MHz and 800 MHz between 800 MHz and 2 5 GHz 0 01 Not applicable Not applicable 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 79 7 27 100 12 23 For transmitters with a max transmitting power that is not listed in the above table the recommended minimum distance d in metres m can be calculated using a formula based on the transmitter s frequency where P is the max transmitting power of the transmitter in ...

Страница 90: ...33 0002 Ferrite core 0 05 0026 Ethernet cable 3 m with ferrite core EASY ELEC 1 pair of disposable adhesive defibrillation pads for adults 80 cm 0 21 0000 1 pair of disposable adhesive defibrillation pads for children 42 cm 0 21 0020 1 pair of disposable adhesive defibrillation pads for adults 80 cm pre connected 0 21 0021 1 pair of disposable adhesive defibrillation pads for children 42 cm pre co...

Страница 91: ...IONAHA 110 971010 Cansell A Effectiveness and Safety of New Transthoracic Cardiac Defibrillation Waveforms Bi phasic Pulses In La Revue des SAMU 20 280 294 2000 9 4 Glossary ABCD The primary ABCD A Airways check if airways are free B Breathing artificial respiration C Circulation circulatory signs or cardiac massage D Defibrillation AED Automated external defibrillator This term is also used for s...

Страница 92: ...scriptions on the front face of th device Expiration date of the accessories elapsed Date Performed by Checks once a Week once a Month Visual inspection of the device and accessories see previous table The green indicator is lit Date Performed by Checks every 3 years Visual inspection of the device and accessories see previous table Functional test Check for proper functioning Measure the leakage ...

Страница 93: ...Page 91 Appendix 9 User Guide Inspection report 9 5 Art no 0 48 0013 Rev m FRED easy ...

Страница 94: ... the battery 11 used on the device 10 Disposal information Accessories into contact with patients 72 At the end of useful life 72 Battery 72 E ECG 62 Electrodes Adult and paediatric electrodes 36 Applying the pads 35 Checking the electrodes 37 Insert connector into device 35 Open the electrode packaging 35 Pre connected pads 35 Electromagnetic interferences 81 Events stored on the memory card 48 F...

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