Evita V800 Technical Documentation IPM Rev 2.0

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Technical Documentation IPM

| Evita V800

Contents

Contents Evita V800

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Use of this documentation ...

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1.1 1.2 1.3 1.4 1.5

Subject to change without notice ... Copyright and other protected rights ... Definition of service concepts ... Laws, regulations and standards ... Screen content (where applicable) ...

4 4 4 4 4

Safety-related information ...

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2.1 2.2 2.3

Requirements for the user group ... Information about safety instructions and warnings... Basic safety information...

5 5 6

Function descriptions...

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3.1 3.2 3.3 3.4

General information ... Control unit ... Pneumatics ventilation unit ... Ventilation unit electronics ...

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Maintenance instructions - not applicable -...

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Parts catalog and test instructions ... 5.1 Parts catalog... 5.2 Test instructions / Service Card IPM ... 5.3 Result Sheet Test instructions / Service Card IPM...

99 99 169 213

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Technical Documentation IPM | Evita V800

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Use of this documentation

1

Use of this documentation This chapter contains information how to use this documentation.

1.1

Subject to change without notice Dräger reserves the right to modify the product and/or this documentation without prior notice. This documentation is intended exclusively as information for service personnel or specialized service personnel.

1.2

Copyright and other protected rights The content of this documentation, in particular the design, text, software, technical drawings, configurations, graphics, figures, data and their selection and composition and any modifications (content) are subject to copyright. The content (in full or in parts) may not be modified, copied, distributed, reproduced, republished, displayed, transmitted or sold without the written permission of Dräger.

1.3

Definition of service concepts Term

Definition

Service

All measures (inspection, maintenance, repair) intended to maintain and restore the functionality of a product

Inspection

Measures intended to determine and assess the actual state of a product

Maintenance

Recurrent specified measures intended to maintain the functionality of a product

Repair

Measures intended to restore the functionality of a product after a device malfunction

Dräger recommends to enter into a service contract with DrägerService.

1.4

Laws, regulations and standards German laws, regulations and standards apply to devices used and serviced in Germany. Users or service personnel in other countries are obliged to comply with relevant national laws and with international standards.

1.5

Screen content (where applicable) Screen content is only shown in this documentation for clarity purposes. The screen content is e.g. shown in English. Variations are possible depending on language settings and the installed operating system. Where necessary, the screen content is clearly referenced to the descriptive text.

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Safety-related information

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Safety-related information This chapter contains information on safety-related information applying to all parts of the technical documentation.

2.1

Requirements for the user group The term “user group” describes the responsible personnel, which is nominated for the respective activities on the product by the operator.

2.1.1

Operator duties The operator must ensure the following: – Every user group has the necessary qualifications (e.g. technical training or technical knowledge based on experience). – Every user group has been briefed in the activity. – Every user group has read and understood the necessary chapter in this document.

2.1.2

User group Maintenance personnel This user group installs the product and performs the maintenance activities. If product-specific know-how or tools are required, the measures must be carried out by specialist maintenance personnel. The specialist maintenance personnel have been trained for these measures on this product by Dräger.

2.2

Information about safety instructions and warnings Safety instructions and warnings warn against dangers and provide instructions for the safe maintenance of the product. Non-observance may result in personal injury, property damage and environmental damage.

2.2.1

Safety instructions This documentation contains safety instructions warning against dangers. The type of danger and the consequences of non-observance are listed in each safety instruction.

2.2.2

Warnings Warnings relate to steps and warn against dangers that may arise when executing the steps. Warnings precede the steps. The following warnings and signal words identify warnings and delineate the potential consequences of non-observance against each other. Warning sym- Signal word bol WARNING

Technical Documentation IPM | Evita V800

Consequences of non-observance Can result in death or serious injury.

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Safety-related information

Warning sym- Signal word bol

Consequences of non-observance

CAUTION

Can result in moderate or light injury.

NOTICE

Can result in property damage.

2.3

Basic safety information

2.3.1

Compliance with the documentation Without exact knowledge of and compliance with this documentation, carrying out the measures described herein could lead to personal injury, damage to property, or damage to the environment. Using the product without exact knowledge of and compliance with the corresponding instructions for use could lead to personal injury, damage to property, or damage to the environment. ► Make sure that you have the current revision of this documentation. Use only the current revision of this documentation. ► Carefully read and comply with the measures described in this documentation. ► Carefully read and comply with the corresponding instructions for use.

2.3.2

Symbols and product labels If the symbols and product labels are not observed, personal injury, property damage or environmental damage may result. ► Observe the symbols and product labels.

2.3.3

Risk of infection After clinical use, the product may be contaminated and transmit pathogens. There is an increased risk of infection with products that have not been reprocessed. ► Only service reprocessed (cleaned and disinfected) products and device components. ► In the case of possibly contaminated components that cannot be reprocessed (e.g., in interiors) take suitable protective measures (such as wearing gloves and a face mask).

2.3.4

Servicing Service activities that are not carried out, carried out incorrectly or by non-experts can lead to personal injury, property damage or environmental damage. If the safety, functionality and condition of the product are not checked during servicing work, risks can go undetected. ► Observe the servicing information contained in the instructions for use. ► Service activities must be carried out regularly and correctly by the user group named for the respective activity. ► Only perform service activities and only connect the service PC if no patient is connected to the product. ► Dräger recommends the use of original parts for servicing work. ► Whenever servicing work has been performed, check the product according to the test instructions.

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Safety-related information

2.3.5

Modifications to the product Modifications to the product may result in malfunctions and subsequently in personal injury (injury or death), property damage, or environmental damage. ► Do not modify the product.

2.3.6

Tools and test equipment Using unsuitable tools and/or test equipment during maintenance can damage the product and impair its features. ► Only suitable tools and designated test equipment should be used when carrying out maintenance work. ► If the designated test equipment has an expiry date, take note of it.

2.3.7

Test values: If test values do not conform to specifications, the safety of the patient may be put at risk. ► If test values do not conform to specifications, do not commission the product. ► Contact your local Dräger service organization.

2.3.8

Electrostatic discharge Electrostatic discharge may damage electrostatic sensitive devices. ► When working on electrostatic-sensitive devices, take suitable protective measures against electrostatic discharge (use, e.g., an anti-static mat and an earthing wrist strap).

2.3.9

Heavy objects Lifting and setting down heavy devices or components may result in injury or damage to the device. ► Make sure to lift and set down the device with the help of at least one other person. ► Place the device or the components on a suitable surface. ► Observe applicable accident prevention regulations.

2.3.10

Disposal of components Components that have been replaced or can no longer be used may contain environmentally harmful substances or pollutants. Components that have not been disposed of in accordance with regulations can lead to environmental damage. ► Dispose of replaced and non-reusable components in accordance with regulations.

Technical Documentation IPM | Evita V800

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Safety-related information

2.3.11

Handling oxygen Where pressurized connectors are used with oxygen, contact with oil or grease may cause a fire. An oxygen fire may lead to injuries and damage to the device. ► Keep oxygen carrying hoses and connectors free from oil and grease on the inside and the outside. ► Wear appropriate gloves when handling oxygen.

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Function descriptions

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Function descriptions This chapter contains descriptions of the device's technical functions.

3.1

General information

3.1.1

Introduction The following section contains a brief introduction to the medical device. The exact function of the electronic and pneumatic assemblies is described in the functional descriptions "Ventilation unit electronics" and "Pneumatics ventilation unit".

Design 44402

3.1.2

Fig. 1 Item 1 2 3 4 5 6

Front view Designation Control unit Ventilation unit Trolley (optional) Gas supply unit (optional) Power supply unit (optional) Nebulizer (optional)

Technical Documentation IPM | Evita V800

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Function descriptions

Item 7 8

Designation Breathing gas humidifier (optional) Other devices and accessories from Dräger or third-party companies (see list of accessories)

3.2

Control unit

3.2.1

Functional description of the display unit

3.2.1.1

Introduction The display unit is the interface between the user and the ventilation unit. A touchscreen and rotary knob are provided for configuration and data input. The set parameters and the measured values are shown on the display. Furthermore, the display contains an alarm bar and the LEDs for indicating the power supply status and the backlight of the rotary knob. The front panel of the display unit also accommodates the on/off key and the alarm silence key. The design and operation of the display unit are described below. Design 43398

3.2.1.2

Fig. 2 Item 1 2 3 4

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Main components of the display unit Designation Rear panel Seal Cover Loudspeaker

Item 8 9 10 11

Designation Rotary Knob PCB ECD Power Button PCB Rotary knob and diffuser Cover with connecting piece of the alarm silence key

Technical Documentation IPM | Evita V800

Function descriptions

3.2.1.3

Item 5

Designation USB ports on the side

Item 12

6 7

ECD Adapter PCB Rotary encoder

13 14

Designation Cover with connecting piece of the on/off key Display with touchscreen Alarm bar

Functional principle Display unit and ventilation unit are connected to a system cable. This system cable is used for communication and power supply. The display unit consists of the following functional blocks: – Alarm bar – ECD Power Button PCB – Rotary Knob PCB – ECD Adapter PCB – Loudspeaker

43399

– Display with touchscreen

Fig. 3

Block diagram of the display unit

Alarm bar The alarm bar is made up of a printed circuit board with LEDs for indicating alarms, a diffuser and a cover. ECD Power Button PCB The printed circuit board comprises the on/off key for turning the device on and the LEDs for indicating the source of the power supply (mains voltage, internal battery, PS500).

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Function descriptions

Rotary Knob PCB The printed circuit board comprises the alarm silence key and the LEDs for the backlight of the rotary knob. Equally connected to the PCB is the rotary knob. ECD Adapter PCB The ECD Adapter PCB is the central interface in the display unit. A microcontroller and a HDBase-T receiver are used to communicate with the ventilation unit. The microcontroller controls the actuators of the following components and reads and analyzes the signals from their sensors: – Loudspeaker – LEDs of the alarm bar, the power supply and the rotary knob backlight – Touchscreen – On/off key, alarm silence key and rotary knob The HDBase-T receiver controls the display and provides the following interfaces: LAN, COM 1 to 3, USB 1 to 4 and HDMI. The DC/DC converter uses the 31 volts the display unit is supplied with to generate the individual supply voltages for the display unit. Loudspeaker The loudspeaker turns the electrical alarm signals and status signals into mechanical movements and thus into sound waves. The loudspeaker's volume can be adjusted. Touch-screen The touchscreen analyzes the contact of the user's finger when touching the screen and transmits the signals to the microcontroller.

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Function descriptions

3.2.1.4

Connections and interfaces

43405

Front view of the display unit

Fig. 4

Front view of the display unit

Item 1

Designation Alarm bar

2 3 4 5 6 7 8

Description The alarm bar briefly flashes when the system is started to indicate the proper functioning of the alarm system.

In the event of an alarm, the alarm bar flashes in the color of the corresponding alarm priority. screen Display with touchscreen. Alarm silence key Pressing this key will disable all acoustic alarm signals for 2 minutes. Rotary knob The rotary knob is used to select and confirm settings and functions. "PS500" LED Indicates the status of the power supply unit PS500 "Internal battery" Indicates the status of the internal battery LED "Mains voltage" Indicates the status of the mains power supply LED On/off button This key is used to turn the device on or off. As long as the device is switched on, the LED inside the key is illuminated.

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Function descriptions

Power supply indication LED LED for mains voltage LED for the internal battery

LED for the power supply unit PS500

LED illuminated in green Mains voltage is available and the main switch is turned on. Battery charge above 90 %.

LED illuminated in yellow -

LED not illuminated

Battery charge between 10 % and 90 %.

The internal battery is defective, discharged or the device was switched off using the main switch. The power supply unit is defective, discharged or the device was switched off using the main switch.

Battery charge above Battery charge 90 %. between 10 % and 90 %.

The device is disconnected from the mains voltage.

43406

Rear view of the display unit

Fig. 5 Item 1

2

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Rear view of the display unit Designation Alarm bar

COM

Description The alarm bar briefly flashes when the system is started to indicate the proper functioning of the alarm system. In the event of an alarm, the alarm bar flashes in the color of the corresponding alarm priority. Connectors for data transmission via MEDIBUS or MEDIBUS.X protocol

Technical Documentation IPM | Evita V800

Function descriptions

Item 3

Designation USB ports

4 5 6

System cable HDMI LAN

Technical Documentation IPM | Evita V800

Description USB ports for exporting data, exchanging configurations and installing software options For connecting the display unit with the ventilation unit Connector for future extensions Connectors for service purposes

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Function descriptions

3.3

Pneumatics ventilation unit

3.3.1

Pneumatics

3.3.1.1

Introduction The pneumatic components are activated by the electronic system. They control the ventilation pressure and the ventilation flow to the patient. Design and operation of the pneumatic system are described below.

3.3.1.2

Design

39644

The pneumatic system consists of the following main components:

Fig. 6

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Pneumatic main components

Item A

Designation Blower adapter

B

Nebulizer/ejector option

C

Gas delivery module assembly

Design The blower adapter is only installed if the device is equipped with the Gas Supply Unit option. (see "Blower adapter", page 49) Detailed description (see "Nebulizer/ejector option", page 45) Detailed description (see "Gas delivery module", page 20)

Technical Documentation IPM | Evita V800

Function descriptions

Designation O2 sensor assembly

E F

Pressure measurement assembly, PVT-Monitoring PCB M4.1 Calibration unit assembly

G

Inspiratory valve assembly

H

Expiratory valve assembly

I

Expiratory flow sensor

J

Barometric pressure sensors

Design The O2 sensor is pneumatically connected to the calibration unit (G) via an attenuator (1). Detailed description (see "PATO O2 Sensor M12.4", page 42) Detailed description (see "PCB PVTMonitoring M4.1", page 80) Detailed description (see "Calibration unit", page 39) Detailed description (see "Inspiratory valve", page 29) Detailed description (see "Expiratory valve / expiratory flow sensor", page 33) Detailed description (see "Expiratory valve / expiratory flow sensor", page 33) The barometric pressure sensors are located on the PI-Main ECD PCB. Detailed description (see "PCB PI-Main ECD", page 71)

Functional principle 39647

3.3.1.3

Item D

Fig. 7

Operating principle of the pneumatic system

Item 1 2

Designation Gas inlet AIR Gas inlet O2

Item 15 16

3

Non-return valve AIR (GDM_CV1)

17

4

Non-return valve O2 (GDM_CV2)

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Technical Documentation IPM | Evita V800

Designation Expiratory flow sensor (S4) Barometric pressure sensors (S8#1 and S8#2) Calibration valve (V8) for inspiratory pressure sensor (S9) Inspiratory pressure sensor (S9)

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Function descriptions

Item 5

Designation Metering valve AIR (GDM_V1)

Item 19

6 7 8 9 10 11 12 13 14

Metering valve O2 (GDM_V2) 20 Tank 21 Metering valve gas mixture (GDM_V3) 22 Safety valve (V5) 23 Emergency exhalation valve (SV2) 24 Emergency respiratory valve (SV3) 25 Patient's lung 26 Expiratory valve (V16) 27 Non-return valve (CV5) 28

Designation Calibration valve (V6) for expiratory pressure sensor (S6) Expiratory pressure sensor (S6) O2 sensor (S1) Nebulizer outlet Pressure reducer AIR (PR1) Pressure reducer O2 (PR2) Nebulizer mixing valve (V10) Nebulizer on-off valve (P9) CO2 sensor (optional) (S5) Neonatal flow sensor (depending on the patient category)

The gas delivery module assembly (C) provides a gas mixture flow with adjustable O2 and AIR proportions. The timing of the flow delivery can be varied. Gas from the (central) gas supply enters the device via the gas inlet connector for O2 and AIR (1, 2). Two non-return valves (3, 4) prevent the gas from flowing back into the supply line of the respective gas. The gases are mixed inside the tank (7). This procedure is administered by two controlled valves (5, 6). A third controlled valve (8) is used to administer the inspiratory flow output. Alternatively, breathing air from the area around the device can be compressed by the GS500 and introduced to the tank using the blower adapter (A). The blower adapter (A) connects the optional gas supply unit (if installed) with the gas delivery module. The inspiratory valve assembly (G) consists of the safety valve (9) and two nonreturn valves (10, 11). The safety valve is closed in normal operation so that the inspiratory flow from the gas mixing assembly and the gas delivery will reach the patient (12). The safety valve is open in all other operating modes, e.g. if the device is in standby mode or in the event of a device failure, and allows the patient to breath spontaneously via the emergency respiratory valve (11). The emergency exhalation valve (10) is a redundant channel for spontaneous expiration to provide for the case that the expiration branch is obstructed. The expiratory valve assembly (H) consists of the expiratory valve (13) and a nonreturn valve (14). The expiratory valve is a proportional valve which is used to adjust the pressure inside the breathing system. In combination with the valve of the emergency outlet (10) the non-return valve (14) prevents pendulum breathing during spontaneous breathing periods. The expiratory flow sensor (I, 15) uses the hot-wire anemometry measuring principle to measure the expiratory flow. For converting the mass flow into a volume flow (BTPS) the device needs to know the ambient pressure. The ambient pressure is measured by the barometric pressure sensors (J, 16). The pressure inside the breathing system is measured by two independent pressure sensors (18, 20). These two sensors constitute the pressure measurement assembly (E). The pressure sensors are calibrated in regular intervals. For this purpose, the pressure sensors are vented into the ambient air through the two calibration valves (17, 19) on the opposite side. Together with another calibration valve for the O2 sensor (21), these calibration valves make up the calibration unit assembly (F).

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Function descriptions

The O2 sensor (D, 21) uses a side stream measurement principle to measures the inspiratory O2 concentration. The measuring gas from this process is expelled into the ambient air and will therefore not reach the patient. The user can purge the O2 sensor during the device check with pure oxygen from the tank (7) to calibrate it. A pneumatic medication nebulizer is connected to the nebulizer gas outlet (22) for nebulizing the medication. The ventilation unit provides an intermittent gas flow consisting of O2 and AIR for operating the medication nebulizer. Intermittently supplying these two gases will ensure that any deviations from the O2 concentration which is set on the device remains within the specified limits. For this purpose, the gas from the two gas inlet connectors (1, 2) is reduced by the pressure reducers (23, 24). The mixing valve of the nebulizer (25) is used to administer the gases in precise intervals. The nebulizer on-off valve (26) closes the nebulizer gas outlet when the nebulizer function is not switched on. Nebulizer mixing valve, nebulizer on-off valve and the two pressure reducers make up the optional nebulizer/ejector assembly (B). The optional MCable Mainstream CO2 sensor (27) is used to measure the CO2 concentration in the breathing gas. The procedure for measuring the CO2 in the Mainstream follows an optical measuring principle. 3.3.1.4

Connections and interfaces

39682

The following illustration provides an overview of the existing pneumatic connections listed in the functional description. Refer to chapter "Diagrams and overviews" for a hose diagram and a pneumatics diagram.

Fig. 8 Item 1 2 3

Pneumatic connections Designation Connector for the compressed gas hose for AIR Connector for the compressed O2 gas hose Gas inlet safety valve

Technical Documentation IPM | Evita V800

Item 4

Designation Nebulizer port

5

Expiratory flow sensor (gas outlet)

6 7

Expiratory valve Inspiratory valve

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Function descriptions

3.3.2

Gas delivery module

3.3.2.1

Introduction The gas delivery module assembly provides a gas mixture flow with adjustable O2 and AIR proportions. The timing of the flow delivery can be varied. Design and operation of the gas delivery module are described below.

3.3.2.2

Design

40221

The gas delivery module is a complete functional unit consisting of the following main components:

Fig. 9

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Main components

Item 1

Designation Valve actuator

2

Printed circuit board PCB M1.3

3

Gas inlet housing

4

Proportional valve AIR

5

Proportional valve O2

6

Flow sensor AIR

7

Flow sensor O2

Design The valve actuator controls the proportional valve GDM_V3 and is attached to the gas outlet housing. The upper diaphragm of the proportional valve GDM_V3 is equally housed in the valve actuator. The printed circuit board M1.3 comprises the electronic system for the gas delivery module. The gas inlet housing comprises the gas connectors for O2 and AIR, the GDM_F1/F2 filter, the metering unit GDM_R1 and the non-return valve GDM_CV1/CV2. The proportional valve AIR is located on the gas inlet housing. The proportional valve O2 is located on the gas inlet housing. The flow sensor is located behind the sealing cap. The flow sensor is located behind the sealing cap.

Technical Documentation IPM | Evita V800