Advanced long-term ICU ventilation unit

Advanced long-term ICU ventilation unit – Tender specification (long version) Page 1 | 27

Advanced long-term ICU ventilation unit

Evita V800

TENDER SPECIFICATION (LONG VERSION)

Advanced long-term ventilation unit

for adult and pediatric patients

for invasive and non-invasive ventilation

with automatic weaning capabilities


Contents

1. Device type ......................................................................................................................... 4

2. General requirement profile .............................................................................................. 4

3. Manufacturer information ................................................................................................. 4

4. Standards, regulations, certificates of compliance ....................................................... 4

5. Scope of delivery ............................................................................................................... 5 5.1 Basic scope of delivery ............................................................................................. 5 5.2 Additional scope of delivery ..................................................................................... 6

6. Application area and patient types .................................................................................. 6 6.1 Application area ......................................................................................................... 6 6.2 Patient types and start-up values ............................................................................ 6

7. Operating concept and handling...................................................................................... 7 7.1 Start behavior............................................................................................................. 7 7.2 Standby ....................................................................................................................... 7 7.3 Device check .............................................................................................................. 7 7.4 Operation concept ..................................................................................................... 8 7.5 Screen layout and configurability ............................................................................ 8

8. Safety functionalities ......................................................................................................... 9

9. Graphical user interface .................................................................................................... 9 9.1 General specifications .............................................................................................. 9 9.2 Curves ....................................................................................................................... 10 9.3 Trends ....................................................................................................................... 10

Display of up to 3 trends on one axis ................................................................................ 10

Recall of trend display up to 7 days ................................................................................... 10

Graphical trend display with magnifying function ............................................................ 10 9.4 Loops ........................................................................................................................ 11 9.5 Logbook .................................................................................................................... 11

10. Ventilation modes .................................................................................................... 11 10.1 Volume controlled ventilation ................................................................................ 11 10.2 Pressure controlled ventilation .............................................................................. 12 10.3 Spontaneous breathing .......................................................................................... 12 10.4 Special ventilation functions .................................................................................. 13

11. Additional ventilation functionalities .................................................................... 13 11.1 Tube compensation ................................................................................................. 13 11.2 Non-invasive ventilation ......................................................................................... 14 11.3 Recruitment maneuvers .......................................................................................... 14 11.4 Low flow P/V loop maneuver .................................................................................. 15 11.5 Weaning methods .................................................................................................... 15 11.6 O2 suction procedure .............................................................................................. 16


11.7 Nebulization ............................................................................................................. 16 11.8 Manual hold functionality ....................................................................................... 17 11.9 Oxygen therapy function ........................................................................................ 17

12. Ventilation monitoring ............................................................................................ 17 12.1 Airway pressure monitoring ................................................................................... 17 12.2 Flow and volume monitoring .................................................................................. 18 12.3 O2 monitoring ........................................................................................................... 18 12.4 CO2 Monitoring ........................................................................................................ 19 12.5 Monitoring of breathing rate, compliance, resistance and I:E ratio ................... 20 12.6 Graphical representation of the current lung status ........................................... 20 12.7 Diagnostic monitoring ............................................................................................ 21

13. Alarm messages and alarm limits ......................................................................... 21 13.1 Alarm messages ...................................................................................................... 21 13.2 Alarm limits .............................................................................................................. 21

14. Interface connections ............................................................................................. 22

15. Cleaning .................................................................................................................... 22

16. Service organization and service mode ................................................................ 23 16.1 Service organization ............................................................................................... 23 16.2 Service mode ........................................................................................................... 23

17. Technical data .......................................................................................................... 24

18. Training material and documentation ................................................................... 26

19. Device data ............................................................................................................... 26

20. Quantity list and total price .................................................................................... 27 20.1 Quantity list .............................................................................................................. 27 20.2 Total price ................................................................................................................. 27


1. Device type

Device type: Advanced long-term ventilator with corresponding touch screen and rotary knob on a trolley

2. General requirement profile

1. Long-term ventilators for use at intensive care units are offered. Along with the standard ventilation types, methods which shorten the withdrawal time of the patient from the ventilation unit must be a part of the device. The ventilator is intended to be used for adult and pediatric patients.

2. A device is expected that is operated easily and intuitively. Therefore the device is equipped with a sufficiently large screen of at least 18” that can be adjusted for user-friendly readability and operation. If necessary, it can be separated and mounted somewhere else.

3. The offer must include all equipment and device parts including the required accessories which are necessary for the intended use of the device.

Specification Requirement fulfilled yes no

Requirement profile was met in all points ( ) ( )

3. Manufacturer information

Manufacturer operates a quality assurance system that is certified pursuant:


EN ISO 9001 ( ) ( )

EN ISO 13485 ( ) ( )

4. Standards, regulations, certificates of compliance

The device is compliant with the basic requirements from Appendix 1 of the Guideline 93/42/EWG. It is CE marked according to Article 17, which requires that the product has undergone a conformity evaluation according to Article 11.


Requirement profile was met in all points ( ) ( )


5. Scope of delivery

5.1 Basic scope of delivery


The offer includes all equipment and device parts including the required accessories which are necessary for device operation.

( ) ( )

Central gas supply hose for O2 ( ) ( )

Central gas supply hose for AIR ( ) ( )

Wide range power supply (100-240 V, 50/60 Hz)

Internal battery for uninterrupted operation for at least 30 minutes ( ) ( )

Patient hose system (reusable) ( ) ( )

Circuit support arm ( ) ( )

Expiration valve (reusable) ( ) ( )

Non-invasive ventilation functionality for all ventilation modes - Maximum leakage compensation of 180 l/min or higher - Automatic continuous adjustment of the inspiratory trigger and

termination criteria according to leak - Automatic flow reduction during disconnection - Alarm for disconnection time (0 – 60 s)

( ) ( )

Integrated continuous high flow oxygen application within the device (device can operate as high flow system for breathing gas delivery with set FiO2 for use e.g. with oxygen masks or nasal prongs)

( ) ( )

Automatic tube compensation with adjustable compensation rate - Tube compensation is available for the mandatory and the

spontaneous phase and for the spontaneous phase only - Tube compensation for in- and expiration and inspiration only

available for all ventilation modes

( ) ( )

Dual Control Ventilation ( ) ( )

Airway Pressure Release Ventiltion including AutoRelease ( ) ( )

Mandatory Minute Ventilation ( ) ( )

Proportional pressure ventilation for supported spontaneous breathing dependant on patients breathing effort

( ) ( )

Automatic weaning method based on CPAP with pressure support - Weaning takes etCO2 measurement into consideration

( ) ( )

Spontaneous breathing can be enabled during all available volume controlled and pressure controlled ventilation modes

( ) ( )

O2 sensor ( ) ( )

Flow sensor ( ) ( )

Trolley ( ) ( )



Ventilation data export for monitoring or hospital information system ( ) ( )

Data download via USB functionality without additional software ( ) ( )

5.2 Additional scope of delivery


Patient hose system available as disposable item ( ) ( )

Main-stream CO2 measurement ( ) ( )

Low flow P/V loop maneuver for the evaluation of the elastic properties of the lung

( ) ( )

Humidifier (selection between active humidification with expiratory heated limb, without expiratory heated limb and HME)

( ) ( )

Nebulizer connection ( ) ( )

Graphical representation of the lung conditions ( ) ( )

6. Application area and patient types

6.1 Application area


The ventilator can be operated: - in intensive care units - in sub acute care wards - in recovery rooms - during transports within the hospital

( ) ( ) ( ) ( )

( ) ( ) ( ) ( )

6.2 Patient types and start-up values


Adult patient type available ( ) ( )

Pediatric patient type available ( ) ( )

Possibility to select the patient types adult pediatric in the start up phase of the ventilation

( ) ( )

Automatic setting of the start values for ventilation according to patient type, patient height or ideal body weight input

( ) ( )


Automatic setting of the alarm limits according to patient type, patient height or ideal body weight input

( ) ( )

Automatic setting of the max. and min. ventilation settings according to patient type, patient height or ideal body weight input

( ) ( )

The settings of the previous patient can be selected as start-up values ( ) ( )

Start up settings for all settable alarm limits can be configured ( ) ( )

Start up settings for ventilation mode and ventilation parameters can be configured

( ) ( )

7. Operating concept and handling

7.1 Start behavior


Automatic software self test after device is switched on ( ) ( )

Manual setting of start ventilation mode, settings and alarm limits for a user specific start configuration

( ) ( )

7.2 Standby


Standby functionality ( ) ( )

Ventilation parameters pre-configurable in standby ( ) ( )

7.3 Device check


Device check is available for valves, sensors, gas supply system and alarms

( ) ( )

Device check is performed in dialog with the user via screen texts ( ) ( )

Breathing circuit check for the patient hose system is available separately including detected leak display in percentage during operation

( ) ( )

Determination and display of compliance, inspiratory and expiratory resistance and leakage of the patient hose system after breathing circuit check

( ) ( )

The results of the last device check and breathing circuit check are saved, stored and reviewable with date and time

( ) ( )


7.4 Operation concept


Device operation via touch screen and rotary knob ( ) ( )

Rotary knob has two functions for an easy operation concept: 1.) rotation for adjustment of the selected item 2.) pushing for confirmation of the selected item

( ) ( )

( ) ( )

Only relevant settings in the applicable ventilation mode are visible ( ) ( )

Color change of activated control elements on the screen ( ) ( )

Parameter settings, measured values and waveform display are visible simultaneously

( ) ( )

Display of four parameter-time curves during the modification of ventilation settings

( ) ( )

Parameter settings electronically secured against inadvertent settings ( ) ( )

Operation of the ventilator without additional proximal or distal filters possible

( ) ( )

Patient connection possible on both right and left side ( ) ( )

Hose system can be exchanged quickly and with one hand motion ( ) ( )

Automatic flow reduction with detected disconnection ( ) ( )

7.5 Screen layout and configurability


Availability of different screen layouts for different use cases ( ) ( )

6 different screen layouts can be configured ( ) ( )

Configured screen layouts are password protected against unauthorized changes

( ) ( )

Display of curves, trends, loops and measured values on the main screen is configurable

( ) ( )

A measurement value box can be user configured to display up to 6 measured values

( ) ( )

Simultaneous display of 4 ventilation curves and 4 short trends ( ) ( )

User-specific data tables can be created ( ) ( )

Display of the data page is configurable to the same order as the written protocol of a hospital

( ) ( )

Individual soft keys for frequently used functions are configurable ( ) ( )

Sequence and display of measured values can be user configured on the main page

( ) ( )


Software language is configurable during ventilation ( ) ( )

Units are configurable (e.g. mbar-cmH2O) ( ) ( )

Time and date are configurable ( ) ( )

Alarm volume is configurable on the main display ( ) ( )

Device configuration can be transferred to another device via USB ( ) ( )

8. Safety functionalities


Automatic compensation of leakages ( ) ( )

Trigger sensitivity and termination criterion automatically adapt to measured leakage

( ) ( )

Display of leakage corrected VT if leakage compensation is activated ( ) ( )

Automatic compensation of device and hose compliance ( ) ( )

Automatic compensation of device and hose resistance ( ) ( )

9. Graphical user interface

9.1 General specifications


High resolution 18.3” color touch screen ( ) ( )

Screen with day/night switch and dimmer ( ) ( )

Time for automatic day/night switch of screen can be configured ( ) ( )

Brightness of screen can be adjusted ( ) ( )

Automatic adjustment of brightness for different light intensities ( ) ( )

Display of curves, trends, loops and numerical values ( ) ( )

Real time graphical information at any time and in any operating situation available (curves or measured values always visible)

( ) ( )

Integrated help function with clear text announcements for diagnostic features

( ) ( )

Integrated on-screen instruction for use in local language ( ) ( )


9.2 Curves


Real time airway pressure curve ( ) ( )

Real time flow curve ( ) ( )

Real time volume curve ( ) ( )

Real time etCO2 curve ( ) ( )

Simultaneous graphical display of airway pressure, flow, tidal volume, CO2 and calculated tracheal pressure possible as real time curves

( ) ( )

Representation of at least three successive ventilator cycles ( ) ( )

Ventilation curves are filled out and not displayed as lines (for better visibility from greater distances)

( ) ( )

Simultaneous display of 4 ventilation curves ( ) ( )

Display of a graphical or numerical trend instead of a curve ( ) ( )

Display of 3 short trends instead of a curve ( ) ( )

Display of 2 loops instead of a curve ( ) ( )

Display of 1 big loop instead of a curve ( ) ( )

All curves with hold function for analysis ( ) ( )

Ability to use cursor tool over frozen curves to display measured values over a specific time

( ) ( )

9.3 Trends


Graphic trend display of all settings and measured values ( ) ( )

Graphic trend display with cursor and numeric display of the value ( ) ( )

Display of a trend instead of a measured value ( ) ( )

Trend resolution selectable from 2, 4, 8 and 12 hours and 1 and 7 days

( ) ( )

Display of up to 3 trends on one axis ( ) ( )

Recall of trend display up to 7 days ( ) ( )

Graphical trend display with magnifying function ( ) ( )


9.4 Loops


Display of the following loops: Paw-V, Flow-Paw, V-Flow, Ptrach-V, Flow-Ptrach

( ) ( )

Reference loops can be measured and recorded at any time (reference loop used to measure the progress of ventilation treatment)

( ) ( )

Storage of reference loops and their display without time restraint ( ) ( )

Ability to display reference loop against measured loop(s) ( ) ( )

Ability to display up to 10 mandatory or spontaneous loops ( ) ( )

Clear color distinction between reference and measured loops ( ) ( )

Display of loops of different sizes with simultaneous display of another curve, short trend, graphic or numerical trend and alarm history

( ) ( )

Loop display with cursor and numerical information of measured value ( ) ( )

All loops with hold function for analysis ( ) ( )

9.5 Logbook


Automatic logbook entries for all ventilation changes and alarms ( ) ( )

Automatic storage of alarm history ( ) ( )

Logbook entries can be saved for up to 7 days ( ) ( )

Logbook entries can be exported via USB ( ) ( )

10. Ventilation modes

10.1 Volume controlled ventilation


Volume controlled, continuous mandatory ventilation ( ) ( )

Volume controlled, assisted controlled ventilation ( ) ( )

Volume controlled, synchronized intermitted mandatory ventilation without and with pressure support

( ) ( )

Volume controlled ventilation with a minimum amount of mandatory minute volume without and with pressure support

( ) ( )


Volume controlled and pressure limited ventilation via Pmax setting for all available volume controlled modes

( ) ( )

Automatic flow adjustment and ventilation pressure adjustment to the smallest possible value with constant tidal volume

( ) ( )

Volume controlled ventilation with free spontaneous patient breathing during the inspiratory and expiratory phase

( ) ( )

10.2 Pressure controlled ventilation


Pressure controlled, continuous mandatory ventilation ( ) ( )

Pressure controlled, assisted controlled ventilation ( ) ( )

Pressure controlled, synchronized intermitted mandatory ventilation without and with pressure support

( ) ( )

Pressure controlled ventilation with spontaneous breathing on two pressure levels without and with pressure support

( ) ( )

Pressure controlled ventilation with a tidal volume guarantee ( ) ( )

Pressure controlled, pressure support ventilation ( ) ( )

Pressure controlled, airway pressure release ventilation ( ) ( )

Automatic and continuous optimization of the expiration time based on the expiratory flow in airway pressure release ventilation

( ) ( )

Pressure controlled ventilation with free spontaneous patient breathing during the inspiratory and expiratory phase

( ) ( )

10.3 Spontaneous breathing


Spontaneous, continuous positive airway pressure with pressure support

( ) ( )

Pressure support with adjustable flow trigger ( ) ( )

Pressure support shall only be active on PEEP level ( ) ( )

Spontaneous, continuous positive airway pressure with volume support

( ) ( )

Volume support with adjustable volume goal and flow trigger ( ) ( )

Spontaneous breathing with a proportional pressure support dependant on patients breathing effort

( ) ( )

Automatic random variation of pressure support in CPAP with pressure support

( ) ( )


10.4 Special ventilation functions


Mandatory ventilation with inversed inspiratory – expiratory time ratio ( ) ( )

Ability to adjust the pressure rise time in pressure-controlled modes, volume-controlled modes, in pressure support and in volume support

( ) ( )

Adjustable apnea ventilation available with automatic flow control ( ) ( )

The apnea ventilation setup page automatically opens when apnea ventilation occurs and ventilation settings dialog is opened

( ) ( )

Automatic return from apnea ventilation configurable ( ) ( )

11. Additional ventilation functionalities

11.1 Tube compensation


Compensation of the tube resistance during in- and expiration ( ) ( )

Tube compensation is available for adults, pediatrics and neonates ( ) ( )

Tube compensation can be used with any invasive ventilation mode ( ) ( )

Compensation rate adjustable from 0% to 100% in increments of 1% ( ) ( )

Tube compensation can be turned off for the expiratory phase ( ) ( )

Tube compensation is available for mandatory and spontaneous ventilation phase

( ) ( )

Tube compensation is selectable for the spontaneous breathing phases only

( ) ( )

Pressure support and proportional pressure support can be used in addition to tube compensation

( ) ( )

Tube type (ET- or trach-tube) can be selected ( ) ( )

Tube diameter is selectable from 2 to 12 mm ( ) ( )

Automatic compensation of the tube resistance due to the selected tube type and tube diameter

( ) ( )

Calculation and display of the tracheal pressure through input of the tube type and tube diameter independently from the use of tube compensation

( ) ( )


11.2 Non-invasive ventilation


Non-invasive ventilation operates in all ventilation modes ( volume controlled, pressure controlled and spontaneous ventilation modes)

( ) ( )

Alarm management adapted to mask ventilation ( ) ( )

Alarm limits (MV low, VT high/low, apnea high) can be deactivated ( ) ( )

Additional alarm for mask disconnection can be delayed from 0 to 60 seconds

( ) ( )

Non-invasive ventilation is available for adults, pediatrics and neonates ( ) ( )

Automatic leakage compensation dependant on patient type: - Adult: up to 180 L/min - Pediatric: up to 60 L/min - Neonatal: up to 30 L/min

( ) ( ) ( )

( ) ( ) ( )

Measurement and display of the leakage minute volume and the relative leakage in %

( ) ( )

Measurement of leakage in % and l/min ( ) ( )

Measurement and display of the leakage corrected tidal volume ( ) ( )

Leakage compensation for the delivered volume in pressure controlled and volume controlled ventilation modes

( ) ( )

Automatic leakage compensation with continuous automatic adjustment of the inspiratory flow trigger and termination criteria

( ) ( )

Leakage corrected wave forms and measured values ( ) ( )

Automatic inspiratory flow reduction during disconnection configurable ( ) ( )

Detection of reconnection with automatic continuation of the ventilation ( ) ( )

Additional control parameter (Timax) to limit the duration of flow cycled breaths

( ) ( )

Different NIV masks for different use cases available ( ) ( )

11.3 Recruitment maneuvers


Direct setting of all ventilation parameters (except O2 and flow) in all ventilation modes without repeated confirmation

( ) ( )

Synchronized adjustment of PEEP and Pinsp (pressure difference remains constant)

( ) ( )

Synchronized setting of RR and Ti (if RR is increased Ti reduces and I:E remains constant)

( ) ( )


Sigh function with adjustable intermittent increased PEEP, duration of the sigh phase and interval between the sigh phases

( ) ( )

CPAP ventilation with a sigh function ( ) ( )

Breath by breath recruitment trend functionality for EIP, PEEP, Cdyn ( ) ( )

11.4 Low flow P/V loop maneuver


Quasi-static P/V loop measuring procedure with analysis tool ( ) ( )

Low flow maneuver to record the elastic lung properties and to determine the opening and closing alveolar pressure with a minimum flow of 2 L/min

( ) ( )

Low flow maneuver with a constant flow for both the inspiratory and the expiratory phase of the maneuver

( ) ( )

Low flow maneuver settable for inspiration only ( ) ( )

Calculation of the static compliance during in- and expiration ( ) ( )

10 P/V loops and associated ventilation settings at the start of the maneuver can be stored

( ) ( )

Determination of the C20/Cstat ratio as an expression of the change of the static compliance for the last 20% of the maneuver

( ) ( )

Automatic determination of the inflection points and the point of maximum curvature possible

( ) ( )

Optimum PEEP and Pinsp can be determined via 2 cursors positioned at the lower and upper inflection point of the P/V Loop

( ) ( )

Possibility to optimize PEEP, Pinsp or VT directly on the graphic display of the Low flow P/V loop

( ) ( )

11.5 Weaning methods


Automatic weaning method based on CPAP with pressure support ( ) ( )

Weaning method is based on a medical knowledge ( ) ( )

Weaning method is available for adults and children ( ) ( )

Weaning method operates automatically on the basis of measured values for VT, f and etCO2

( ) ( )

Weaning method has the goal to reduce the pressure support until the readiness for extubation

( ) ( )


Weaning method classifies the patients breathing in diagnosis (e.g. “Hyperventilation”) based on measured values for VT, f and etCO2

( ) ( )

Pressure support is adjusted automatically based on the diagnosis ( ) ( )

Stabilization of the patient in an area of respiratory comfort ( ) ( )

Weaning method automatically performs a spontaneous breathing trial ( ) ( )

Weaning method automatically informs about a successful spontaneous breathing trial

( ) ( )

Graphical display of all weaning activities ( ) ( )

Weaning process can be adapted to patients with COPD and/or neurological disorders

( ) ( )

Pause from weaning can be set and configured (night rest) ( ) ( )

11.6 O2 suction procedure


Program for time controlled oxygen enrichment for bronchial suction with muting of selective alarms

( ) ( )

Pre-oxygenation phase of max. 180 sec. (oxygen concentration can be configured)

( ) ( )

Automatic detection of disconnection and interruption of ventilation ( ) ( )

Muted selected alarms during disconnection time (max. 120 sec.) ( ) ( )

Reduced gas flow during disconnection time ( ) ( )

Automatic termination of O2 suction procedure after 120 sec. of disconnection with attempt to continue the ventilation

( ) ( )

Automatic detection of reconnection and continuation of ventilation ( ) ( )

Post-oxygenation phase of max. 120 sec. (oxygen concentration can be configured)

( ) ( )

11.7 Nebulization


Integrated pneumatic nebulizer with selectable duration ( ) ( )

Indication and timer shown during the activation of nebulizer ( ) ( )

Automatic calibration of flow sensor after nebulizer application is completed

( ) ( )

Nebulizer therapy possible in all ventilation modes ( ) ( )

Unchanged FiO2 application during the operation of the nebulizer ( ) ( )


Adaptation of tidal volume delivery concerning the additional nebulization gas delivery

( ) ( )

Synchronized operation of the nebulizer (gas delivery) to inspiratory flow delivery with constant MV

( ) ( )

11.8 Manual hold functionality


Inspiration hold: Manual Inspiration: Ventilation stroke can be manually started and held for max. 40 sec.

( ) ( )

Expiration hold: Ventilation pause can be manually started and held for max. 45 sec.

( ) ( )

11.9 Oxygen therapy function


Integrated continuous high flow oxygen application within the device ( ) ( )

Flow and FiO2-concentration can be set for O2 therapy ( ) ( )

12. Ventilation monitoring

12.1 Airway pressure monitoring


Electronic measurement of the airway pressure ( ) ( )

Airway pressure measurement is integrated into the device without the need for additional pressure lines

( ) ( )

Automatic calibration of the pressure sensors during ventilation ( ) ( )

Measurement of peak inspiratory pressure ( ) ( )

Measurement of plateau pressure ( ) ( )

Measurement of mean airway pressure ( ) ( )

Measurement of positive end-expiratory pressure ( ) ( )

Measurement of minimum pressure ( ) ( )

Measurement of end-inspiratory pressure for mandatory breaths ( ) ( )

The Safety relief valve is electronically connected to high airway pressure alarm threshold

( ) ( )


12.2 Flow and volume monitoring


Integrated electronic measurement of flow and volume ( ) ( )

Automatic calibration of flow sensor every hour during ventilation ( ) ( )

Manual calibration of flow sensor at any time during ventilation ( ) ( )

Changing of flow sensor without interruption of ventilation possible ( ) ( )

Availability of a reusable flow sensor ( ) ( )

Availability of a disposable flow sensor ( ) ( )

Measurement of tidal volume ( ) ( )

Measurement of inspiratory tidal volume of mandatory breaths ( ) ( )

Measurement of expiratory tidal volume of mandatory breaths ( ) ( )

Measurement of inspiratory tidal volume of spontaneous breaths ( ) ( )

Measurement of expiratory minute volume ( ) ( )

Measurement of inspiratory minute volume ( ) ( )

Calculation of the leakage corrected minute volume ( ) ( )

Measurement of spontaneous minute volume ( ) ( )

Calculation and display of spontaneous portion of minute volume ( ) ( )

Measurement of mandatory minute volume ( ) ( )

Calculation and display of leakage minute volume in % and/or in L/min ( ) ( )

Automatic correction of the tidal volume measurements dependant on humidification type

( ) ( )

Possibility to switch off flow monitoring without interrupting ventilation ( ) ( )

Continued ventilator operation with switched off flow monitoring ( ) ( )

Automatic detection and indication of a defective flow sensor ( ) ( )

12.3 O2 monitoring


Integrated electronic measurement of the inspiratory oxygen concentration FiO2

( ) ( )

O2 measurement with a consumption-free sensor ( ) ( )

Automatic calibration of O2 sensor during device check ( ) ( )

Selective alarm muting for O2 monitoring ( ) ( )


Possibility to switch off O2 monitoring ( ) ( )

Continued ventilator operation with switched off O2 monitoring ( ) ( )

12.4 CO2 Monitoring


Electronic measurement of the end-expiratory CO2 concentration ( ) ( )

Mainstream CO2 measurement at the patients Y-piece ( ) ( )

Display of an undelayed capnogram in synchrony with pressure, flow and volume measurement and curves

( ) ( )

Display of a volumetric capnogram FCO2/VT; PCO2/VT ( ) ( )

Display of the slope of the third phase of the capnogram ( ) ( )

Capnography measurement value (etCO2) displayed as a curve and as a numeric value in vol.%, kPa or mmHg

( ) ( )

Measurement of end-expiratory CO2 partial pressure and CO2 concentration respectively with adjustable alarm thresholds

( ) ( )

Display trend of etCO2 concentration ( ) ( )

Display of CO2 production in L/min ( ) ( )

Display of CO2 proportion in tidal volume in mL ( ) ( )

Display of serial dead space ( ) ( )

Display of dead space ventilation ( ) ( )

Check of the CO2 sensor on a reference filter ( ) ( )

Zeroing of CO2 sensor at ambient ( ) ( )

Calibration of the CO2 sensor with sample gas ( ) ( )

Measurement signal processing in the ventilator without requirement of additional measuring sensors or tubes

( ) ( )

Possibility to switch off CO2 monitoring ( ) ( )

Continued ventilator operation with switched off CO2 monitoring ( ) ( )

Sensor weight under 35 grams ( ) ( )

Sensor has no moving parts ( ) ( )

Sensor is exchangeable between different ventilators of the same manufacturer without the need to recalibrate

( ) ( )

Availability of reusable CO2 cuvettes ( ) ( )

Availability of disposable CO2 cuvettes ( ) ( )


12.5 Monitoring of breathing rate, compliance, resistance and I:E ratio


Integrated electronic measurement of breathing rate ( ) ( )

Display of respiratory rate in total ( ) ( )

Display of the spontaneous respiratory rate ( ) ( )

Display of the mandatory respiratory rate ( ) ( )

Display of triggered breaths ( ) ( )

Inspiratory to expiratory time ratio for mandatory ventilation ( ) ( )

Inspiratory to expiratory time ratio for spontaneous breathing ( ) ( )

Calculation and digital display of dynamic compliance in all modes (except CPAP without pressure support)

( ) ( )

Automatic calculation and digital display of resistance in all modes (except CPAP without pressure support)

( ) ( )

Measurement of expiratory time constant ( ) ( )

Display of total, spontaneous and mandatory respiratory rate ( ) ( )

12.6 Graphical representation of the current lung status


Ability to provide lung and tracheal visual illustrating current resistance and compliance during ventilation

( ) ( )

Graphical representation of current compliance in anatomical analogy to the lung

( ) ( )

Graphical representation of current resistance in anatomical analogy of the airways

( ) ( )

Representation of lung resistance excluding ET tube resistance ( ) ( )

Graphical illustration providing clear representation of spontaneous and mandatory ventilation pattern

( ) ( )

Ability to provide visual illustration representing current spontaneous breathing activity in combination with current resistance and compliance activity

( ) ( )

Graphical (including symbol) representation of trigger activity ( ) ( )

Ability to perform a “calibration” measurement of current lung status as reference for ventilation management

( ) ( )

Automatic information of overflow or conditions measured outside the current reference measurement recommending a new calibration may be performed

( ) ( )


12.7 Diagnostic monitoring


Measuring maneuver "intrinsic PEEP" at the push of a button ( ) ( )

PEEPi maneuver performable in all ventilation modes ( ) ( )

Measurement of trapped volume obtained during PEEPi maneuver ( ) ( )

Measurement of the neuromuscular breathing drive via P0.1 in all ventilation modes

( ) ( )

P0.1 measurement at the push of a button ( ) ( )

P0.1 measurement in automatic intervals ( ) ( )

Trend display for P0.1 measurements ( ) ( )

Measurement of the Rapid Shallow Breathing Index RSBi ( ) ( )

Measurement of the patients maximum inspiratory effort NIF ( ) ( )

13. Alarm messages and alarm limits

13.1 Alarm messages


Alarm messages by priority (Note / Caution / Warning) ( ) ( )

Priorities can be differentiated visually and acoustically ( ) ( )

Automatic alarm volume change for day and night mode configurable ( ) ( )

360 degree alarm light ( ) ( )

Affected parameters are highlighted on the screen in case of an alarm if parameter is configured (displayed on screen)

( ) ( )

Plain text information is displayed on the screen in case of alarms and extremely dangerous settings

( ) ( )

A fault – cause – remedy help function with clear text display is integrated in the device for all alarms

( ) ( )

13.2 Alarm limits



The following alarm limits can be adjusted individually (in a comprehensive overview)

( ) ( )

Alarm limits for minute volume (high/low) ( ) ( )

Alarm limits for tidal volume (high/low) ( ) ( )

Alarm limits for total respiratory rate (high) ( ) ( )

Alarm limits for airway pressure (high) ( ) ( )

Alarm limits for etCO2 (high/low) ( ) ( )

Alarm limits for apnea alarm delay time (5-60 sec) ( ) ( )

Alarm limit for disconnection time available in NIV (0-60 sec) ( ) ( )

Delay for minute volume alarm (high/low) can be configured (15-30 sec)

( ) ( )

14. Interface connections


Digital interface (RS 232) (3 ports) ( ) ( )

USB interface ( ) ( )

Connection for proximal flow sensor for neonatal ventilation ( ) ( )

Connection for CO2 sensor ( ) ( )

15. Cleaning


Smooth surface of the operating panel can be wipe-disinfected with manufacturer specific cleaning agents

( ) ( )

Patient expiration valve can be exchanged easily using one hand ( ) ( )

Patient inspiration valve can be exchanged easily using one hand ( ) ( )

Compact patient expiration valve without the requirement of a connected heated or non-heated filter

( ) ( )

Availability of a heated expiratory filter ( ) ( )

Compact patient expiration valve with opening for integrated water trap ( ) ( )

Patient expiration valve can be sterilized at 134 ºC ( ) ( )

Patient inspiration valve can be sterilized at 134 ºC ( ) ( )

Reusable patient hose system can be sterilized at 134 ºC ( ) ( )


16. Service organization and service mode

16.1 Service organization


The service organization offers a customer tailored service agreement ( ) ( )

The service organization provides a 24 hour emergency-service ( ) ( )

The service network is active in over 190 countries worldwide ( ) ( )

Spare and wear parts will be available for at least 8 years after production is stopped

( ) ( )

Availability of spare parts in 24 - 48 hours (from order entry) via distribution centers in Europe and North America

( ) ( )

Upgrades and updates for the ventilator software are performed as a download using a standard PC without the need to exchange hardware

( ) ( )

16.2 Service mode


Entering the service mode is achieved through the regular ventilator controls (without tools)

( ) ( )

The diagnostic service mode is protected against unauthorized interaction

( ) ( )

The service mode displays measured values, status messages of the pneumatic and an overview table containing electronic circuits and the microprocessor activity

( ) ( )

The service mode contains a log of error codes including messages ( ) ( )

Upgrades and updates are performed as a download using a standard PC without the need to exchange hardware

( ) ( )

Remote service is available via local data download and internet connection to the service department of the manufacturer

( ) ( )


17. Technical data

Settings

Respiratory Rate RR adjustable from 0.5 to 150 1/min

Inspiration time Tinsp adjustable from 0.1 to 10 s

Tidal volume VT adjustable from 20 to 3000 L

Insp. flow adjustable from 2 to 120 L/min

Insp. pressure Pinsp adjustable from 1 to 95 mbar

Insp. pressure limit Pmax adjustable from 2 to 100 mbar

O2 concentration adjustable from 21 to 100 Vol%

PEEP adjustable from 0 to 50 mbar

Intermittent PEEP adjustable from 0 to 50 mbar

Trigger sensitivity adjustable from 0.2 to 15 L/min

Pressure support adjustable from 0 to 95 mbar

Rise time for pressure support adjustable from 0 to 2 s

Inspiratory termination for PS, PPS, VS from 5 to 70 %

Inspiration time Thigh in APRV adjustable from 0.1 to 30 s

Expiration time Tlow in APRV adjustable from 0.05 to 30 s

Inspiration pressure Phigh in APRV adjustable from 1 to 95 mbar

Inspiration pressure Plow in APRV adjustable from 0 to 50 mbar

Exp. termination criterion %PEFR in APRV from 1 to 80 %

Automatic Tube Compensation ET Tube Ø adjustable

from 2 to 12 mm

Automatic Tube Compensation Trach. Tube Ø adjustable

from 2.5 to 12 mm

Degree of tube compensation adjustable from 0 to 100 %

Apnea alarm time adjustable from 0. to 15 s

Flow Assist in PPS from 0 to 100 mbar/L/s

Volume assist in PPS from 0 to 100 mbar/L

Continuous Flow in O2 therapy from 2 to 50 L/min

O2 concentration in O2 therapy from 21 to 100 Vol%

Performance Data

Duration of intermittent PEEP from 1 to 20 exhalations


Time interval between the sigh phases from 20s to 180 min

Duration of medication nebulization 5, 10, 15, 30 minutes, continuously min

Max. insp. flow 180 L/min

Measured values

Airway pressure measurement value (Ppeak, PPlat, PEEP, Pmean, Pmin)

from -60 to 120 mbar

O2 measurement from 18 to 100 Vol%

Tidal volume measurement (VT, VTimand, VTemand, VTispon Vtrap)

from 0 to 5500 L

Minute volume measurement (MV, MVmand, MVspon)

from 0 to 99 L/min

Respiratory Rate measurement (RR, RR spon, RR mand.)

from 0 to 300 1/min

etCO2 measurement from 0 to 100 mmHg

CO2 production VCO2 from 0 to 1000 mL/min

Serial death space Vds from 0 to 999 mL

Ventilation of death space Vds/VT from 0 to 100 %

Compliance C from 0 to 650 mL/mbar

Resistance R from 0 to 1000 mbar/L/s

Leakage minute volume MVleak from 0 to 99 L/min

Rapid-Shallow-Breathing RSB from 0 to 9999 1/(min x L)

Negative Inspiratory Force NIF from -80 to 0 mbar

Occlusion pressure P 0.1 from 0 to -25 mbar

General device features

Screen type Capacitive touchscreen with glass front

Screen diagonal 464.8 mm (18.3 in) mm

Device dimensions (W x H x D) 581 x 1413 x 776 mm

Weight of base unit 16 kg

Environmental conditions during operation

Temperature from 10 to 40 °C

Relative humidity from 10 to 90 %

Air pressure from 700 to 1060 hPa


Environmental conditions during storage and transport

Temperature from -20 to 45 °C

Relative humidity from 45 to 85 %

18. Training material and documentation


Instruction for use available ( ) ( )

Service manual available ( ) ( )

Interactive training with basics in ventilation and respiration ( ) ( )

Display can be connected to an external projector (analogue or digital) for training purposes

( ) ( )

19. Device data

Product Evita V800

Model / Item no. .......................................................................

Language of the software: .......................................................................

Language of the user manual: .......................................................................

Operating voltage ....................................... V, Hz

Power consumption ....................................... W

Protection class .......................................

Classification .......................................

No. of the entity named .......................................

UMDNS code .......................................


20. Quantity list and total price

20.1 Quantity list

Item Device description Piece Unit price € Total price €

20.2 Total price

Total net price

VAT (……%)

Total gross price

Advanced long-term ICU ventilation unit

Documents