Primus
Babylog and Neonatal Ventilator Series
C500 , VN500 , GS500 and PS500Technical Documentation IPM Rev 8.0
Technical Documentation
326 Pages
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Page 1
Technical Documentation IPM
Workstation Critical Care
Warning All servicing and/or test procedures on the device require detailed knowledge of this documentation. Use of the device requires detailed knowledge and observance of the relevant Instructions for Use.
C500, V500, GS500, PS500
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Technical Documentation IPM
| Workstation Critical Care
Table of contents
Table of contents 1
2
3
4
5
6
General...
5
1.1
General notes ...
5
Abbreviations ...
8
2.1
List of abbreviations...
8
Function descriptions ...
10
3.1
General points about the workstation ...
10
Function descriptions pneumatic assembly ...
12
4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11
Pneumatic assembly... Gas metering module M1.3 ... Basics of flow measurement... Explanation of the terms NTPD, BTPS and NTPS ... Inspiratory unit/safety valve unit ... Expiratory valve/expiratory flow sensor ... Neonatal expiratory valve ... Calibration unit... PATO O2 sensor M12.4... Nebulizer/ejector option ... Blower adapter...
12 16 23 24 25 28 31 34 38 41 44
Function descriptions - Electronics ...
47
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17 5.18 5.19 5.20
Electronic assembly... Battery NiMH M7 ... Power supply unit M7.3 ... Fan unit fan... "Power supply unit M7.3 plus" ... Power PCB ... Therapy Control Unit PCB M16 ... SysCon PCB... Main PCB... Connector PCB... OLED-Contact PCB ... OLED-Controller PCB... PVT-Monitoring M4.1 PCB ... RFID M21 PCB ... Valve drive M15.1 ... Lift magnet M15.2 ... MCable-Mainstream CO2 sensor M11.1... Heating fan ... Nurse call... Neo Flow PCB ...
47 51 53 56 57 62 66 69 71 76 79 80 82 85 88 92 94 98 99 101
Function descriptions C500 (MS18746) ...
104
6.1
104
Infinity C500...
Technical Documentation IPM | Workstation Critical Care
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Table of contents
7
Function descriptions C500 (MK31500, MK31501) ...
109
7.1
Infinity C500 function description...
109
Function descriptions - GS500 ...
114
8.1
Gas supply unit GS500...
114
Function descriptions - PS500 ...
123
9.1
PS500 power supply unit ...
123
10 Maintenance instructions...
128
8
9
10.1 10.2 10.3 10.4 10.5
Opening and closing the device... Replacing battery pack M7 under M7.3 ... Replacing battery pack M7 under M7.3 Plus ... Replacing the O2 filter M1.3_F2 ... Replacing the air filter M1.3_F1...
128 134 138 142 145
11 Maintenance instructions - GS500 ...
149
11.1 11.2
Replacing the filter mat ... Replacing the respiratory gas filter ...
149 152
12 Maintenance instructions - PS500...
157
12.1 12.2
Replacing the batteries ... Battery characteristic and power supply unit firmware ...
157 168
13 Parts catalog and test instructions ...
172
13.1 13.2 13.3
4
Parts catalog... Test Instructions / Service Card IPM ... Result Sheet Test instructions / Service Card IPM...
172 272 321
Technical Documentation IPM | Workstation Critical Care
General
1
General This chapter contains general notes and definitions that are important for the use of this documentation.
1.1
General notes
1.1.1
Notes on use Read through the following notes thoroughly before applying this documentation. The basic safety information defined here applies to all parts of this documentation. Dräger reserves the right to make changes to the device and/or to this documentation without prior notice. This documentation is intended exclusively as information for service personnel or specialized service personnel.
1.1.2
Copyright and other protected rights The content of this documentation, in particular its design, text, software, technical drawings, configurations, graphics, images, data and their selection and its composition and any amendments to it (content) are protected by 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 the author.
1.1.3
Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, could result in personal injury or property damage. NOTE A NOTICE provides additional information intended to avoid inconvenience during operation or service of the product. Term Service Inspection Maintenance Repair
Definition All measures (inspection, maintenance, repair) intended to maintain or restore the functional integrity of a product Measures intended to determine and assess the current state of a product Regular specified measures intended to maintain the functional integrity of a product Measures intended to restore the functional integrity of a product after a failure
Technical Documentation IPM | Workstation Critical Care
5
General
1.1.4
Basic safety information CAUTION Incorrect use of tools The proper operation of the device may be impaired, or the device may be damaged. Always use the correct tools and the specified test equipment. WARNING The device must be regularly inspected and serviced by service personnel. Repairs and complex service work on the product must be carried out by specialized service personnel. If you require a service contract, or for any necessary repair work, Dräger recommends DrägerService. Dräger recommends using original parts for servicing. If the aforementioned instructions and recommendations are ignored, the correct functioning of the product may be put at risk. Observe the information on service in the instructions for use. WARNING Untested product If the safety, functional integrity and condition of the product are not checked during service, this could result in personal injury, property damage or damage to the environment. Check the product in accordance with the test instructions during every service. WARNING Non-conforming test values If test values do not conform to specifications, the safety of the patient may be put at risk. – Do not put the device into operation if test values do not conform to specifications. – Contact your local service organization. WARNING Changes to the device If changes are made to the device, the safety of the patient may be put at risk. Only modify the device with permission from Dräger. WARNING Risk of infection The device may transmit pathogens following use on the patient. – Before carrying out any servicing, ensure that the device and its components have been handed over by the user cleaned and disinfected. – Service only cleaned and disinfected units and unit components.
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Technical Documentation IPM | Workstation Critical Care
General
WARNING Risk to patient Ensure that no patient is connected to the device before starting maintenance or repair work. NOTE Where reference is made to legislation, regulations and standards, in respect of devices used and serviced in Germany they are based on the laws of Germany. Users and technicians in other countries must comply with their national laws and/or international standards.
Technical Documentation IPM | Workstation Critical Care
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Abbreviations
2
Abbreviations This section contains a list of the abbreviations used in this document.
2.1
List of abbreviations
2.1.1
Abbreviations Abbreviation ADC APRV ATC autoPPS bpm BSP BTPS
C CDPOC Δ Psupp DAC dynamic PEEPi EAST EEPROM EMC f fEIT FiO2 FPGA FRC Heliox I: E ILV LVDS MEDIBUS MMV MV MVi NIF NIV NTPD OP Pa PAN
8
Explanation Analog/Digital Converter Airway Pressure Release Ventilation Automatic Tube Compensation automatic Proportional Pressure Support breaths per minute Board Support Package Body Temperatur Pressure Saturated, measurements referred to conditions of the patient's lung, body temperature 37 °C, ambient pressure, water vapor saturated gas Compliance Cross Domain Point of Care Application Pressure support Psupp setting relative to PEEP Digital/Analog Converter Positive end-expiratory pressure Electronic Accessory Signature Technology Electrically Erasable Programmable Read Only Memory Electro Magnetic Compatibility Respiratory rate functional Electrical Impedance Tomography Inspiratory O2 concentration Field Programmable Gate Array Free Residual Capacity Gas mixture, mostly 79% helium, 21% oxygen Inspiratory-to-expiratory time ratio Independent Lung Ventilation Low Voltage Differential Signaling Dräger communications protocol for medical devices Mandatory Minute Volume Ventilation Minute Volume = product of the VT and f settings (VT x f) Inspiratory minute volume Measurement of Negative Inspiration Force Non-Invasive Ventilation (mask ventilation) Normal Temperature Pressure Dry Operational amplifier Pascal, unit of pressure; 1 mbar = 100 Pa = 1 hPa; 1 bar = 100 kPa = 1000 hPa Patient Area Network
Technical Documentation IPM | Workstation Critical Care
Abbreviations
Abbreviation Paw PI Pinsp PIP Pmax Pmean PPS R RFID SC SPI VG V-Unit
Explanation Airway pressure Product Integration Setting of the upper pressure level in Pressure Control mode Measured inspiratory peak pressure Setting of the maximum permitted airway pressure Mean airway pressure Proportional Pressure Support Resistance Radio Frequency Identification System Cable Serial Peripheral Interface Volume Guarantee Ventilation unit
Technical Documentation IPM | Workstation Critical Care
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Function descriptions
3
Function descriptions This chapter contains descriptions of the device's technical functions.
3.1
General points about the workstation
3.1.1
Introduction The following provides a brief introduction to the workstation. The detailed functionality of the electronic and pneumatic components is set out in the function description "Electronic assembly" and "Pneumatic assembly".
Design 773
3.1.2
Fig. 1 Item 1 2 3 4 5 6 7 8
10
Front view of workstation Designation Display unit Ventilation unit Trolley option Gas supply unit option Power supply unit option Nebulizer option Humidifier option Other devices and accessories from Dräger or third parties (see accessories list)
Technical Documentation IPM | Workstation Critical Care
Function descriptions
3.1.3
Functional principle The modular workstations permit implementation of standardized treatment processes and procedures in all areas of care. All functional units of a workstation can be deployed in different care environments. The workstations are configured according to customer requirements. They comprise monitoring and control displays as well as additional units, devices or accessories.
Technical Documentation IPM | Workstation Critical Care
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Function descriptions pneumatic assembly
4
Function descriptions pneumatic assembly This chapter contains descriptions of the pneumatic components and of the device's technical functions.
4.1
Pneumatic assembly
4.1.1
Introduction The pneumatic components are actuated by the electronics and regulate the ventilation pressure and ventilation flow to the patient. The following details the design and function of the pneumatic assembly.
4.1.2
Design
305
The pneumatic assembly consists of the following main components:
Fig. 2 Item A
Designation Gas metering module M1.3
B
Inspiratory unit/safety valve unit module Expiratory valve module
C
12
Main pneumatic components Design For a detailed description see 4.2 Gas metering module M1.3 For a detailed description see 4.5 Inspiratory unit/safety valve unit For a detailed description see 4.6 Expiratory valve/expiratory flow sensor
Technical Documentation IPM | Workstation Critical Care
Function descriptions pneumatic assembly
Item D
E
F G H
I J
Design For a detailed description see 4.6 Expiratory valve/expiratory flow sensor Barometric pressure sensor The barometric pressure sensor is located on the PI Main PCB. For a detailed description see 5.9 Main PCB Pressure measurement module, For a detailed description see 5.13 PVTPVT Monitoring PCB M4.1 Monitoring M4.1 PCB Calibration unit module For a detailed description see 4.8 Calibration unit PATO O2 sensor module M12.4 The PATO O2 sensor M12.4 is pneumatically connected via an attenuator (1) to the calibration unit (G). For a detailed description see 4.9 PATO O2 sensor M12.4 Nebulizer/ejector option For a detailed description see 4.10 Nebulizer/ejector option Blower adapter This blower adapter is only installed if the gas supply unit option is fitted.
Functional principle 306
4.1.3
Designation Expiratory flow sensor
Fig. 3
Functional principle of the pneumatics
Item 1 2 3
Designation Gas inlet - Air Gas inlet O2 Air non-return valve (M1_3_CV1)
Item 15 16 17
4
O2 non-return valve (M1_3_CV2)
18
Technical Documentation IPM | Workstation Critical Care
Designation Expiratory flow sensor (S4) Barometric pressure sensor (S8) Calibration valve (V8) for inspiratory pressure sensor (S9) Inspiratory pressure sensor (S9)
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Function descriptions pneumatic assembly
Item 5
Designation Air metering valve (M1_3_V1)
Item 19
6 7 8 9 10 11 12 13 14
O2 metering valve (M1_3_V2) Gas mixing tank Mixed gas metering valve (M1_3_V3) Safety valve (V5) Emergency expiratory valve (SV2) Emergency respiratory valve (SV3) Patient's lung Expiratory valve (V16) Non-return valve (CV5)
20 21 22 23 24 25 26 27
Designation Calibration valve (V6) for expiratory pressure sensor (S6) Expiratory pressure sensor (S6) PATO O2 sensor (S1) Nebulizer outlet Air pressure regulator (PR1) O2 pressure regulator (PR2) Nebulizer mixing valve (V10) Nebulizer switching valve (V9) CO2 sensor (optional) (S5)
The gas metering module M1.3 (A) delivers the timed variable flow of a gas mixture with adjustable O2 and air content. Gas from the (central) supply system enters the device via the gas inlet ports for O2 and air (1, 2). Two non-return valves (3, 4) prevent each gas from flowing back into the supply line of the other. The gases are mixed in the tank (7), and the mixing process is controlled by way of two regulated valves (5, 6). The delivered inspiratory flow is controlled by way of a third regulated valve (8). The blower adapter (J) connects the optionally fitted gas supply unit to the gas metering module. The inspiratory unit/safety valve unit module (B) comprises the safety valve (9) and two non-return valves (10, 11). In normal operation the safety valve is closed, so that the inspiratory flow passes from the gas mixing and metering module to the patient (12). In the other operating states, such as when the ventilation unit is in Standby mode, the safety valve is open and permits spontaneous inspiration through the emergency respiratory valve (11). The emergency expiratory valve (10) provides a second channel for spontaneous expiration if the expiratory branch is blocked. The expiratory valve module (C) consists of the expiratory valve (13) and a nonreturn valve (14). The expiratory valve is a proportional valve, and its purpose is to adjust the pressure in the respiratory system. The non-return valve (14), in conjunction with the emergency air outlet valve (10), prevents rebreathing during spontaneous breathing. The expiratory flow sensor (D, 15) measures the expiratory flow based on the hot-wire anemometry measuring principle. Conversion of the mass flow into a volumetric flow (BTPS) requires knowledge of the ambient pressure. The ambient pressure is measured with the barometric pressure sensor (E, 16). The pressure in the respiratory system is measured by two independent pressure sensors (18, 20). They together make up the pressure measurement module (F). The pressure sensors are balanced cyclically. For that purpose, the pressure sensors are vented to atmosphere via the two calibration valves (17, 19). Together with an additional calibration valve for the O2 sensor (21), the calibration valves make up the calibration unit (G). The PATO O2 sensor (H, 21) measures the inspiratory O2 concentration based on a sidestream measuring principle. For calibration by the user in the device check, the O2 sensor can be flushed with pure O2 from the tank (7).
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Technical Documentation IPM | Workstation Critical Care
Function descriptions pneumatic assembly
For drug nebulizing, a pneumatic drug nebulizer can be connected to the nebulizer gas outlet (22). To drive the drug nebulizer the ventilation unit delivers an intermittent gas flow comprising O2 and air. Cycling of the two gases ensures that the variation from the preset O2 concentration remains within the specified limits. The gas from the two gas inlet ports (1, 2) is throttled by the pressure regulators (23, 24) for the purpose. The gases are cycled by means of the nebulizer mixing valve (25). The nebulizer switching valve (26) closes the nebulizer gas outlet when the nebulizer function is not active. The nebulizer mixing valve, the nebulizer switching valve and the two pressure regulators make up the optional nebulizer/ejector module (I). The CO2 concentration of the respiratory gas can be measured with the optional MCable-Mainstream CO2 sensor (27). The CO2 is measured in the main stream based on an optical measuring principle. The internal gas consumption figures of the ventilation unit in standby mode are < 1 L/min AIR and < 2 L/min O2; in operating mode 2 L/min basic consumption (gas mixture as per FiO2 setting) + ventilation dependent on minute volume (gas mixture as per FiO2 setting). The gas return flow of the device meets the requirements laid down in section 6 of the ISO 11195:1995 standard: "Gas mixers for medical use - single devices".
4.1.4
Connections and interfaces
307
The following illustration shows an overview of the existing pneumatic connections mentioned in the function description. For tubing and pneumatic diagrams see "Schematics and diagrams".
Fig. 4 Item 1 2 3
Pneumatic connections of the ventilation unit Designation Expiratory valve Inspiratory unit with safety valve Safety valve gas inlet
Item 4 5 6 7
Technical Documentation IPM | Workstation Critical Care
Designation Nebulizer port Expiratory flow sensor Connection for AIR compressed gas tube Connection for O2 compressed gas tube
15
Function descriptions pneumatic assembly
4.2
Gas metering module M1.3
4.2.1
Introduction The gas metering module M1.3 delivers the timed variable flow of a gas mixture with adjustable O2 and air. The following details the design and function of the gas metering module M1.3.
4.2.2
Design
596
The gas metering module M1.3 forms a complete function unit and comprises the following main components:
Fig. 5
16
Main components
Item 1
Designation Valve drive
2
M1.3 PCB
3
Gas inlet housing
4
AIR/Heliox proportional valve
5
O2 proportional valve
6
AIR/Heliox flow sensor
7
O2 flow sensor
8
Mixing tank
Design The valve drive controls the proportional valve M1_3_V3 and is attached to the housing of the gas outlet. The upper diaphragm of the proportional valve M1_3_V3 is also housed in the valve drive. The PCB includes the electronics for the gas metering module. The housing of the gas inlet incorporates the gas connections for O2 and AIR/Heliox, the filters M1_3_F1/F2, the metering unit M1_3_R1 and the nonreturn valves M1_3_CV1 / CV2. The AIR/Heliox proportional valve is located on the housing of the gas inlet. The O2 proportional valve is located on the housing of the gas inlet. The flow sensor is located behind the cap. The flow sensor is located behind the cap. The mixing tank is located between the housings of the gas inlet and gas outlet.
Technical Documentation IPM | Workstation Critical Care
Function descriptions pneumatic assembly
Designation Cap
10
Gas outlet housing
Design Behind the cap are the gas inlets from the O2, AIR/Heliox flow sensors, the optional gas supply unit, and the gas feed to the mixing tank. In the housing of the gas outlet are the lower diaphragm of the proportional valve M_1_3_V3 and the flow sensor M1_3_S3.
Functional principle 599
4.2.3
Item 9
Fig. 6
Principle
Two proportional valves mix oxygen and air or Heliox (a mixture of helium and oxygen) from a central compressed gas supply into a mixing tank based on preset parameters. A proportional valve downstream of the mixing tank meters the inspiratory flow from the tank to the patient. Sensors measure the flow, pressure and temperature of the gases. Together with the actuators of the valves, they form a control circuit for precise metering of the patient flow. A gas supply unit can also be connected in place of the AIR compressed gas supply. A printed circuit board (PCB) amplifies the measured values of the sensors, converts them into digital signals (A/D converter) and delivers them to a microprocessor system by way of the interface. A D/A converter and amplifier are used to operate the valves and calibrate the flow sensors.
Technical Documentation IPM | Workstation Critical Care
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Function descriptions pneumatic assembly
4.2.4
Pneumatics function
597
The pneumatic system is supplied with gas via central supply ports (M1_3_C1/C2) or by an optional gas supply unit (M1_3_C_3). Proportional valves control the gas flow at the gas outlet (M1_3_C6).
Fig. 7
Pneumatic diagram
Item M1_3_C1/C2
Designation AIR/Heliox, O2 supply inlet
M1_3_F1/F2
Filter
M1_3_R1
Restrictor 0.7 L/min/6 bar
M1_3_CV1/CV Non-return valve 2 M1_3_C4/C5
Additional AIR/Heliox and O2 outlet
M1_3_V1/V2
Proportional valve
18
Pneumatics function Compressed air/Heliox and oxygen from a central gas supply is connected to the ports M1_3_C1 and M1_3_C2. The gas flows through the filters M1_3_F1/F2 to the non-return valves. The mechanical design of filters M1_3_F1 and M1_3_R1 together forms a water trap for the AIR/Heliox connection. A continuous flow of 0.7 L/min discharges any moistures by way of the metering unit. From the non-return valves M1_3_CV1/ CV2 the gas flows to the proportional valves M1_3_V1/V2. Options such as a nebulizer or ejector can be connected to the auxiliary outlet C4 and C5. The proportional valves meter air/Heliox and oxygen into the tank according to the preset O2 concentration and the pressure in the mixing tank (approximately 400 mbar) (closed pressure control loop). The flow of the proportional valves is measured by the downstream flow sensors M1_3_S1/S2.
Technical Documentation IPM | Workstation Critical Care
Function descriptions pneumatic assembly
Item M1_3_F4/F5
M1_3_S1/S2
M1_3_F6/F7
M1_3_C3
M1_3_S4
MC M1_3_C7 M1_3_S7
M1_3_F3 M1_3_S3
M1_3_V3
M1_3_S6
M1_3_S8
Designation Filter (component of flow sensor)
Pneumatics function The function of the two filters M1_3_F4/F5 upstream of the flow sensors is to keep the flow steady. The flow sensors transmit the measured valAIR/Heliox and O2 flow sensor ues to the electronics unit, which then actuates the proportional valves. Filter (wire mesh) The filters M1_3_F6/F7 downstream of the flow sensors prevent crosstalk from the oxygen to the air/Heliox flow sensor and vice versa. Gas supply unit connection A gas supply unit can be connected to the inlet M1_3_C3. In operation with a gas supply unit the pressure in the tank is around 50 to 100 mbar. Temperature sensor upstream of mix- To improve the accuracy of the flow meaing tank surement at the flow sensor M1_3_S3, the temperature at the inlet of the mixing tank (M1_3_S4) and at the outlet of the proportional valve (M1_3_S6) is measured. Mixing tank 0.5 L In the mixing tank the gases are intermingled to form a homogeneous gas mixture. Mixed gas outlet The outlet of the mixed gas is used to monitor and regulate the O2 concentration. Mixing tank pressure sensor The pressure sensor on the mixing tank transmits the pressure to the electronics of the gas metering module. If the pressure falls below the pressure value preset by the electronics, the proportional valves are opened according to the preset O2 concentration. Filter (component of flow sensor) The filter M1_3_F3 ensures a uniform flow to the flow sensor. LPSV flow sensor With the flow sensor M1_3_S3 the flow to the downstream proportional valve is measured and the proportional valve M1_3_V3 is regulated accordingly. Proportional valve (LPSV = Low Press- The (LPSV = Low Pressure Servo Valve) sure Servo Valve) proportional valve M1_3_V3 actuated by the valve drive M15.1 meters an inspiratory flow to the patient according to the preset values. Temperature sensor directly behind The temperature sensor S6 measures the LPSV temperature behind the proportional valve and so the temperature of the gas flow to the patient. Temperature sensor behind LPSV The measured values from the temperature sensor M1_3_S8 can be used to determine the inspiratory gas temperature of other components. The pressure sensor is also used to monitor M1_3_S6.
Technical Documentation IPM | Workstation Critical Care
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Function descriptions pneumatic assembly
Item M1_3_C6 M1_3_C8
4.2.5
Designation Respiratory gas outlet
Pneumatics function The gas flows via the respiratory gas outlet to the patient. Inspiratory pressure sensor connection The optional inspiratory pressure sensor routes the pressure signal outwards and can be used there by other components.
Electronics function
598
The electronics of the gas metering module comprises a printed circuit board (M1.3 PCB). All sensors and valves apart from M1_3_S8 are operated by the PCB.
Fig. 8
Block diagram, M1.3 PCB
Item M1_3_S1 M1_3_S2 M1_3_S3 S5 M1_3_S4 M1_3_S6 M1_3_S7 M1_3_S8
20
Designation AIR/Heliox flow sensor O2 flow sensor LPSV flow sensor Temperature sensor directly on PCB Temperature sensor upstream of mixing tank Temperature sensor directly behind LPSV Mixing tank pressure sensor Temperature sensor behind LPSV
Electronics function Driver modules amplify the sensor signals and forward them to A/D converters. The A/D converters convert the analog measured value into a digital value and make it available on a bus system (LVDS=Low Voltage Differential Signaling). The signal of the pressure sensor (M1_3_S7) is also available for external pressure monitoring. To calibrate the flow sensors (M1_3_S1, M1_3_S2, M1_3_S3) the driver modules are actuated by D/A converters.
Technical Documentation IPM | Workstation Critical Care