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Directive 93/42/EEC
concerning Medical Devices

Manufacturer

Dräger Medical GmbH

Moislinger Allee 53 – 55
D-23542 Lübeck
Germany
+49 451 8 82-0

FAX

+49 451 8 82-20 80
http://www.draeger.com

9054353

– en

© Dräger Medical GmbH
Edition: 2 – 2015-01
(Edition: 1 – 2014-01)
Dräger reserves the right to make modifications
to the device without prior notice.

As of 2015-08:

Dräger Medical GmbH

changes to

Drägerwerk AG & Co. KGaA

Содержание Evita V300

Страница 1: ...al device read and comply with the instructions for use and this supplement Status Draft 5 March 2015 08 47 Infinity Acute Care System Workstation Critical Care and Neonatal Care Infinity Acute Care System Evita Infinity V500 Infinity Acute Care System Babylog VN500 Evita V300 ...

Страница 2: ... 2014 meet the re quirements of the 3rd edition of the IEC 60601 1 standard Typographical conventions Applies to Workstation Critical Care and Neonatal Care Evita Infinity V500 Babylog VN500 Evita V300 Use of terms Dräger uses the term Accessory not only for ac cessories in the sense of IEC 60601 1 but also for consumable parts removable parts and attached parts The designation Infinity Acute Care...

Страница 3: ...d The operating or ganization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices Device combinations approved by Dräger meet the requirements of the following standards IEC 60601 1 3rd edition general requirements for safety device combinations software con trolled functions IEC 60601 1 2 electromagnetic compatibil ity IEC 60...

Страница 4: ...n inspiratory O2 concentration If an additional flow is delivered by an external flow source the actual O2 concentration deliv ered may deviate from the displayed values Use additional monitoring e g external SpO2 monitoring if necessary WARNING Risk of patient injury If leakages are present e g with non invasive ventilation the actual tidal volume may devi ate from the measured values for VTe and...

Страница 5: ...5 Application Application Applies to Evita Infinity V500 Babylog VN500 Evita V300 Environment of use Do not operate the device with helium or helium mixtures ...

Страница 6: ...G93111 Humidifier holder side rail 8416325 Observe the permitted maximum distance to the trolley and the permitted maximum load see Max imum loads of holders on page 8 Abbreviations Abbreviation Explanation BTPS Body Temperature Pressure Satu rated measured values based on the condition of the patient s lungs body temperature 37 C 98 6 F water vapor saturated gas ambi ent pressure and airway press...

Страница 7: ...ese instructions for use Label with notice Transport within the hospital Nominal weight and maximum weight for information see chapter Technical data Temperature limitation during storage Ambient pressure Relative humidity Use by Keep dry nom 58 kg 128 lbs max 133 kg 293 lbs ...

Страница 8: ...Breathing gas humid ifier medication neb ulizer Humidifier holder can be swiveled G93111 On the side of the trolley 5 kg 11 lbs Breathing gas humid ifier Humidifier holder side rail 8416325 On the side rails of the ventilation unit1 1 Maximum load on the side rails of the ventilation unit 5 kg 11 lbs per side rail 5 kg2 11 lbs 2 If a hinged arm is attached to the side rails of the ventilation unit...

Страница 9: ...peutic decisions The MEDIBUS interface is not in tended for use with a distributed alarm system according to IEC 60601 1 8 2012 CAUTION Additional components in the breathing circuit such as bacterial filters HME or CO2 cuvettes may increase the dead space compressible vol ume and resistance Particular care and monitoring are required when using additional components Before checking the breathing ...

Страница 10: ...ains voltage or without a pro tective ground the user can be injured and the device damaged Only connect the power cable to power sock ets with a protective ground and the correct mains voltage Observe the technical data NOTE The mains power socket in use must be freely ac cessible during operation WARNING Risk of patient injury All data transferred via the nurse call are for information only and ...

Страница 11: ...it z Set the hinged arms to minimum extension z Drain the water container of the breathing gas humidifier z Secure the breathing gas humidifier to the trol ley not to the side rails of the ventilation unit z Do not attach any additional parts to the side rails of the ventilation unit z If fitted slide the bed coupling into its retracted position z Grasp the trolley handle firmly and push the de vi...

Страница 12: ...dby dialog window cannot be closed with the X button C Checking readiness for operation Performing the breathing circuit check Starting the breathing circuit check Prerequisite The page System check A Breathing circ check B is open The check has been started 4 When requested by the device in the instruction field E Seal the patient connection port e g with a sterile glove Confirm with OK F 5 When ...

Страница 13: ...alarm criteria can be found in the instructions for use in chapter Alarm Cause Remedy High priority alarm message 1 Start ventilation 2 After 2 minutes set the upper alarm limit for MVe to a value below the measured value MVe The MV high alarm is triggered Medium priority alarm message For Evita Infinity V500 and Evita V300 1 Start ventilation 2 Set the upper alarm limit for VT to a value below th...

Страница 14: ... is exceeded the correspond ing alarm is triggered Additional information on set ting alarm limits can be found in the instructions for use chapter Setting alarm limits Test of the acoustic alarm system The acoustic alarm system need not be tested by the user The device tests the functions of the acoustic alarm system automatically during the de vice check ...

Страница 15: ... Undetected worsening of the patient s condition During high frequency ventilation with Volume Guarantee the ventilator automatically compen sates for changes in lung mechanics As a result a gradual worsening of patient condition may only be detected after a delay Observe patient condition Check ventilation pres sure regularly and set the alarm limits accordingly ...

Страница 16: ...chment for suction maneuver Closed suction WARNING Risk of patient injury during suction in a closed breathing circuit Using closed suction systems produces neg ative pressure in the patient s airways This leads to impaired ventilation and therefore to impaired gas exchange Observe patient condition ...

Страница 17: ...een removed medication nebuli zation is not interrupted If the parameter field for continuous nebulization Cont neb has been configured for display the du ration of medication nebulization is displayed Mains power supply DC power supply Applies to Evita Infinity V500 Babylog VN500 Evita V300 Battery charging The battery charge display applies to both charging and discharging CAUTION Ventilation im...

Страница 18: ...alibration of the Infinity ID flow sensor Short inspiratory times are extended to approximately 1 second The device displays information about the calibration in the message field C At the completion of calibration the Start button B turns pale green WARNING Risk of fire Residual vapors of easily flammable disinfectants e g alcohols and deposits that were not removed during reprocessing can ignite...

Страница 19: ...Evita Infinity V500 Evita V300 Low Flow PV Loop maneuver overused Evita Infinity V500 Alarm history The alarm history is part of the logbook The length of the alarm history depends on the number of log book entries When the logbook reaches its maximum size the oldest entry in the logbook is deleted as each new entry is logged Switching the device off and on are not recorded in the logbook Setting ...

Страница 20: ...settings Setting the alarm tone Setting the minimum alarm volume Configuring the minimum alarm volume sets the lower limit of the factory setting for the volume of the alarm tone 10 to 100 This allows the setting range to be adjusted to the acoustical situa tion at operation site Prerequisite The System setup Alarms Alarm vol tone page is opened 1 Touch the A button 2 Set the value for the minimum...

Страница 21: ...m Depending on the setting IEC CEI or Dräger venti lation alarm messages have the following priority B IEC CEI Priority of the battery alarm in ac cordance with IEC 60601 2 12 C Dräger ventilation Priority of the battery alarm ac cording to Dräger Alarm message Priority IEC CEI Priority Dräger ventilation Battery activated Low priority alarm message High priority or medium priority alarm message B...

Страница 22: ...nter password and confirm with Enter Displaying general status information z Touch the General status tab B The following information is displayed 159_neu System setup A B C D E F G C Next service due D Cockpit Operating hours Standby Operating hours Running E Ventilation unit Operating hours Standby Operating hours Running Battery installation date F Gas supply unit GS500 Operating hours Blower I...

Страница 23: ...ition persists to avoid reverse flow into the Air supply Central Air supply insufficient Gas delivery system is supplied with Air delivered by GS500 Check connection to central air supply and to gas supply unit GS500 Make sure that the supply pressure is greater than 3 bar 43 5 psi Adjust ventilation settings if necessary 140 Airway pressure negative averaged Applies only to Babylog VN500 Average ...

Страница 24: ...Connect device immediately to the mains power supply 250 Battery low The battery is almost discharged Connect device to the mains power supply 251 Battery low The battery is almost discharged Connect device to the mains power supply 100 Continuous nebulization activated Continuous nebulization was activated by the user To end continuous nebulization press the Cancel button if required 253 Device f...

Страница 25: ...ilure 2 Internal safety system failure Do not use this device for ventilation therapy Call DrägerService 140 PEEP high Expiratory valve or breathing circuit obstructed Check breathing circuit and expiratory valve Check for condensate Expiratory resistance increased Check viral bacterial filter Replace it if necessary Device failure Disconnect patient from the device and continue ventilation withou...

Страница 26: ...nfirm with rotary knob 200 Ventilation mode not confirmed The ventilation mode has been changed but not confirmed If necessary change the ventilation mode and confirm the change with the rotary knob 140 VThf not reached Applies only to Babylog VN500 Tidal volume could not be reached due to increased resistance Check patient condition Check ventilation settings Tidal volume could not be reached due...

Страница 27: ...tory unit may be contaminated Additional information on reprocessing can be found in the instructions for use Reprocessing list Semi critical medical devices Safety information concerning the reprocessing of the neonatal flow sensor Items which can be reprocessed Recom mended re processing in tervals Pre cleaning Machine cleaning and disinfection Manual Steriliza tion Cleaning Disinfec tion Breath...

Страница 28: ...es to Evita Infinity V500 Babylog VN500 Evita V300 Overview WARNING Risk of patient injury Performing maintenance work during ventila tion endangers the patient Only perform maintenance work when no pa tient is connected to the device ...

Страница 29: ... racy of the associated measured values The accuracies indicated apply only under the fol lowing conditions The device is ready for operation see chapter Getting started Any accessories being used are approved for the device see the list of accessories The type of humidification is selected correctly in the Start Standby Br circuit Humidifier dialog window The tolerances do not include the measure...

Страница 30: ... including additional components Evita Infinity V500 Evita V300 Compliance 3 mL mbar or mL hPa or mL cmH2O Inspiratory resistance 10 mbar L s at 30 L min 10 hPa L s at 30 L min 10 cmH2O L s at 30 L min Expiratory resistance 10 mbar L s at 30 L min 10 hPa L s at 30 L min 10 cmH2O L s at 30 L min Breathing circuit for pediatric patients including additional components Compliance 1 5 mL mbar or mL hP...

Страница 31: ...ncentration in dry air FiO2 Drift of measurement accuracy 0 2 Vol in 6 hours in accordance with ISO 21647 ISO 80601 2 55 The measured val ues of the O2 measurement are barometrically pressure compensated CO2 measurement in mainstream End expiratory CO2 concentration etCO2 Measurement conditions Respiratory rate adults 6 to 40 min Respiratory rate pediatric patients 40 to 100 min Inspiratory time 2...

Страница 32: ... V500 Static compliance determined by Low Flow PV loop maneuver Cstat 0 to 500 mL mbar or mL hPa or mL cmH2O Monitoring Applies to Evita Infinity V500 Babylog VN500 Sound pressure level LPA of alarm signals meas ured in accordance with IEC 60601 1 8 and A1 2012 3rd edition Alarm tone sequence IEC CEI Range for high priority alarms according to volume setting Approx 55 dB A to 72 dB A Range for med...

Страница 33: ... and A1 2012 3rd edition Alarm tone sequence IEC CEI Range for high priority alarms according to volume setting Approx 56 dB A to 74 dB A Range for medium priority alarms accord ing to volume setting Approx 48 dB A to 65 dB A Range for low priority alarms according to volume setting Approx 53 dB A to 71 dB A Alarm tone sequence Dräger ventilation Range for high priority alarms according to volume ...

Страница 34: ...ISO 3744 2010 A class mean surface sound pressure level LPA with a radius of 2 m 79 in Approx 33 dB Approx 43 5 dB with GS500 Approx 50 with HFO Babylog VN500 Uncertainty k 3 5 dB A class surface sound pressure level LWA Approx 46 dB Approx 57 5 dB with GS500 Approx 63 5 dB with HFO Babylog VN500 Uncertainty k 3 5 dB Weight Ventilation unit Approx 17 kg 37 5 lbs Medical Cockpit with holder Approx ...

Страница 35: ...an appropriate alarm Additionally the integrated monitoring alarms in the following situations Failure of the external power supply Battery discharge Failure of the gas supply Maximum load Universal holder with standard rail G93140 10 kg 22 lbs Humidifier holder can be swiveled G93111 5 kg 11 lbs Humidifier holder side rail 8416325 5 kg 11 lbs If a hinged arm is attached to the side rails of the v...

Страница 36: ...utoRelease is activated PEEP high Plow high The alarm limit is 4 mbar 4 cmH2O above the set PEEP value An alarm is triggered if this condition applies for 2 breaths or after a maxi mum of 15 seconds PEEP low Plow low only for Evita Infinity V500 and Evita V300 A too low PEEP or Plow value during ventilation is monitored The alarm limit depends on the set value of the PEEP or Plow level The alarm l...

Страница 37: ...e set alarm limits The minimum tidal volume is monitored only when Volume Guarantee is activated To accomplish this with leakage compensation switched off the value VTi is monitored in the patient category Ped pat and the value VTe is monitored in the patient cate gory Neo When leakage compensation is acti vated VT is generally used and the automatically set alarm limit VT low is monitored whereby...

Страница 38: ...rk is changed these risks must be identified analyzed and eval uated and appropriate measures taken Examples of subsequent changes to the network Changing the network configuration Removing devices from the network Adding new devices to the network Performing upgrades or updates on devices that are connected to the network Information on connecting to the network Prerequisites This device must onl...

Страница 39: ...smitted Without firewall and antivirus software Data are not protected Device settings are changed The device generates false alarms or no alarms Data are sent incomplete sent to the wrong de vice or not sent at all Patient data are intercepted falsified or dam aged Data have incorrect time stamps Electrical requirements of connected devices and networks The analog and digital ports are only appro...

Страница 40: ...nstruc tions for use in the chapters Assembly and prepa ration and Operation Flow reduction Anti Air Shower When the Anti Air Shower function is activated and a disconnection is detected during ventilation the flow is reduced until reconnection is detected Simultaneously the Disconnection alarm is dis played With non invasive ventilation the time be fore the alarm is triggered can be delayed with ...

Страница 41: ...41 This page intentionally left blank ...

Страница 42: ... 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com 9054353 en Dräger Medical GmbH Edition 2 2015 01 Edition 1 2014 01 Dräger reserves the right to make modifications to the device without prior notice As of 2015 08 Dräger Medical GmbH changes to Drägerwerk AG Co KGaA ...

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