Table of Contents
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Status: Draft, 5. March 2015 08:47
Supplement to
instructions for use
– 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
WARNING
To properly use this medical device,
read and comply with the instructions
for use and this supplement.
SW 2.n
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Table of Contents
Related Manuals for Dräger Infinity Acute Care System Workstation Critical Care
Summary of Contents for Dräger Infinity Acute Care System Workstation Critical Care
- Page 1 Status: Draft, 5. March 2015 08:47 Supplement to instructions for use – 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 SW 2.n WARNING To properly use this medical device,...
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Page 2: Typographical Conventions
Supplement to instructions for use This supplement applies only to the listed medical devices and updates the information of the respec- tive instructions for use. Each chapter indicates the medical devices to which the information applies. Medical device Part number of instructions for use Infinity Acute Care System 9052077... -
Page 3: For Your Safety And That Of Your Patients
For your safety and that of your patients For your safety and that of your patients General safety information Training Applies to: – Workstation Critical Care and Neonatal Care Training for users is available via the Dräger organ- – Evita Infinity V500 ization responsible (see www.draeger.com). -
Page 4: Product-Specific Safety Information
For your safety and that of your patients Product-specific safety information Applies to: CAUTION – Evita Infinity V500 Risk of patient injury – Babylog VN500 – Evita V300 An additional flow delivered by an external flow source can affect the measured values for airway WARNING pressure and flow. -
Page 5: Environment Of Use
Application Application Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Environment of use Do not operate the device with helium or helium mixtures. -
Page 6: Range Of Functions
Overview Overview Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Range of functions Connecting accessories Accessories can be attached to the following hold- ers: – Universal holder with standard rail (G93140) – Humidifier holder, can be swiveled (G93111) –... - Page 7 Overview Symbols Symbol Explanation Attention! Warning! Strictly follow these instructions for use. Label with notice: "Transport within the hospital" Nominal weight and maximum weight (for information, see nom. 58 kg (128 lbs) max. 133 kg (293 lbs) chapter "Technical data") Temperature limitation during storage Ambient pressure...
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Page 8: Assembly And Preparation
Assembly and preparation Assembly and preparation Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Safety information WARNING Risk of tipping over Do not tilt the device by more than 5°. Prepare trolley 2 – 90 cm Securing accessories to the standard rail Maximum loads of holders... - Page 9 Assembly and preparation Preparing the Medical Cockpit Using the MEDIBUS or the MEDIBUS.X protocol WARNING Risk of patient injury All data transferred via the MEDIBUS interface are for information only and must not be used as the sole basis for diagnostic or therapeutic decisions.
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Page 10: Connecting The Mains Power Supply
Assembly and preparation Connecting the mains power supply WARNING Risk of electric shock and of device failure If the device is connected to a power socket with incorrect mains voltage or without a pro- tective ground, the user can be injured and the device damaged. -
Page 11: Transport Within The Hospital
Assembly and preparation Transport within the hospital Transport refers to any movement of the medical device without the patient that does not serve to po- sition the medical device. Increasing the tipping stability Swivel the control and display unit (Medical Cockpit) until it is centrally aligned with the ven- tilation unit. -
Page 12: Getting Started
Getting started Getting started Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 The Start/Standby > Start/Standby page is Start/Standby organized as follows: – The text on the combined button (A) changes depending on the mode in use: –... - Page 13 Getting started Display of results of the breathing circuit check use in chapter "Alarms." Additional information on alarm criteria can be found in the instructions for use Prerequisite: The System check page (A) is in chapter "Alarm – Cause – Remedy." opened.
- Page 14 Getting started Checking alarm limits The alarm limits for a settable alarm can be checked by setting the alarm limits appropriately. When the alarm limit 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."...
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Page 15: Operation
Operation Operation Setting ventilation Applies to: Babylog VN500 Additional settings for ventilation Ventilation parameters for the additional set- tings CAUTION 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. - Page 16 Operation Special maneuvers Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Oxygen enrichment 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.
- Page 17 Operation Medication nebulization Applies to: Continuous medication nebulization – Evita Infinity V500 Prerequisite: The Special maneuvers > – Babylog VN500 Nebulization page is open. – Evita V300 Special maneuvers Safety information on medication nebulization ∞ CAUTION Ventilation impaired If unapproved pneumatic medication nebulizers are used, the actually delivered tidal volume and concentration may deviate from the displayed values.
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Page 18: Flow Monitoring
Monitoring Monitoring Flow monitoring Applies to: Sensors/Parameters – Evita Infinity V500 – Babylog VN500 – Evita V300 WARNING Risk of fire Residual vapors of easily flammable disinfectants (e.g., alcohols) and deposits that were not removed during reprocessing can ignite when the flow sensor is in use. –... -
Page 19: Acknowledging Alarm Messages
Alarms Alarms Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Displaying information on alarms Acknowledging alarm messages The following alarm messages that can be ac- knowledged are not listed: Alarm messages that can be acknowledged are –... -
Page 20: Configuring Alarm Settings
Configuration Configuration Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Information on configuration The Exchange intervals page has been renamed to System status. Information on the exchange inter- vals can be found at System setup > System sta- tus >... - Page 21 Configuration Setting the priority of the battery alarm The device offers the following priorities for battery alarms: IEC/CEI Priority of the battery alarm in ac- cordance with IEC 60601-2-12 Dräger Priority of the battery alarm ac- ventilation cording to Dräger The Battery activated alarm message indicating the changeover to battery operation can be config- ured as a high- or medium-priority alarm when...
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Page 22: System Status
Configuration System status The System status page contains the following in- Displaying general status information formation: Touch the General status tab (B). – General status information on maintenance and The following information is displayed: operating hours – Exchange intervals C Next service due 1 Touch the System setup... -
Page 23: Alarm - Cause - Remedy
Alarm – Cause – Remedy Alarm – Cause – Remedy Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Alarm Alarm message Cause Remedy priority Air supply low, GS500 Air supply insufficient to Check connection to Air active deliver the required flow supply. - Page 24 Alarm – Cause – Remedy Alarm Alarm message Cause Remedy priority Battery activated The ventilation unit is Connect device to the powered by the battery as mains power supply. there is no mains power supply. – If PS500 is not con- nected, the maximum operating time is 30 minutes.
- Page 25 Alarm – Cause – Remedy Alarm Alarm message Cause Remedy priority Device failure (11) A failure was detected Disconnect patient from the during the start-up phase. device and continue ventilation without delay using another independent ventilator. Call DrägerService. Device failure (12) A system failure was Disconnect patient from the detected.
- Page 26 Alarm – Cause – Remedy Alarm Alarm message Cause Remedy priority Setting not confirmed One or more settings have If necessary, change these been changed but not settings and confirm the confirmed. change with the rotary knob. Standby mode activated Device has been switched Acknowledge standby to standby mode.
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Page 27: Cleaning, Disinfection And Sterilization
Cleaning, disinfection and sterilization Cleaning, disinfection and sterilization Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Safety information on reprocessing The components filled with contaminated gas dur- ing normal operation and in the event of a fault must be reprocessed. -
Page 28: Maintenance
Maintenance Maintenance Applies 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. -
Page 29: Technical Data
Technical data Technical data Ambient conditions Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 During operation Altitude Up to 3000 m (9842 ft) Set values Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 The desired parameters can be set without loss of accuracy using the therapy controls. -
Page 30: Performance Characteristics
Technical data Set values (cont.) Pediatric patients <35 s Neonates <15 s Performance characteristics Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 ∞ Medication nebulization For 5, 10, 15, 30 minutes, continuously ( Accuracy of measured values Depending on the patient category, the accuracies indicated for the measured values apply to the fol- lowing performance characteristics of the breath-... - Page 31 Technical data Performance characteristics (cont.) Breathing circuit for neonates including addi- tional components ≤1.5 mL/mbar (or mL/hPa or mL/cmH Compliance ≤44 mbar/L/s at 15 L/min Inspiratory resistance ≤44 hPa/L/s at 15 L/min ≤44 cmH O/L/s at 15 L/min ≤44 mbar/L/s at 15 L/min Expiratory resistance ≤44 hPa/L/s at 15 L/min ≤44 cmH...
- Page 32 Technical data Displayed measured values (cont.) Accuracy ±12 % of the measured value or ±12 mL, whichever is greater, under calibration conditions (1013 mbar (1013 cmH O), dry gas, 20 °C (68 °F)), 5 % CO flow sensor flap closed and no leakage Exhaled CO per breath VTCO...
- Page 33 Technical data Monitoring (cont.) Alarm tone sequence Dräger ventilation Range for high-priority alarms according to Approx. 55 dB(A) to 72 dB(A) volume setting Range for medium-priority alarms accord- Approx. 53 dB(A) to 70 dB(A) ing to volume setting Range for low-priority alarms according to Approx.
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Page 34: Operating Data
Technical data Operating data Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Mains power supply Inrush current Approx. 8 to 24 A peak Approx. 6 to 17 A quasi-RMS Degree of protection against ingress of liquids and IP21 particles Protection against particles with a diameter of more... -
Page 35: Essential Performance Characteristics
Technical data Operating data (cont.) 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 ventilation unit in addition to the humidifier holder (8416325), the maximum load of 5 kg (11 lbs) per side rail must be observed. -
Page 36: Pressure Monitoring
Technical data Automatic alarm limits Pressure monitoring Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Alarm message Description/Detection PEEP high / Plow high The alarm limit is 8 mbar (8 cmH O) above the set PEEP or Plow level. The alarm triggers a pressure release to ambient pressure. -
Page 37: Electromagnetic Compatibility
Technical data Volume monitoring Applies to: Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 The expiratory minute volume MVe is monitored in The expiratory minute volume MVe is monitored the patient category Ped. pat. and in the case of in- within the set alarm limits. - Page 38 Technical data Connections to IT networks Applies to: Information on connecting to the – Evita Infinity V500 network – Babylog VN500 – Evita V300 Prerequisites Data can be exchanged in an IT network using This device must only be connected to the network wired and wireless technologies.
- Page 39 Technical data Consequences of using an unsuitable network If the network does not meet the requirements, dan- gerous situations can result. The following situa- tions can occur with this device: – Due to an insecure decentralized alarm system: – Alarms or data are transmitted at the wrong time.
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Page 40: Principles Of Operation
Principles of operation Principles of operation Applies to: – Evita Infinity V500 – Babylog VN500 – Evita V300 Pneumatic functional description An active breathing gas humidifier and an pneu- matic medication nebulizer can also be installed. Additional information can be found in the instruc- tions for use in the chapters "Assembly and prepa- ration"... - Page 41 This page intentionally left blank.
- Page 42 Directive 93/42/EEC concerning Medical Devices Manufacturer Dräger Medical GmbH Moislinger Allee 53 – 55 D-23542 Lübeck Germany +49 451 8 82-0 +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 As of 2015-08: to the device without prior notice.