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Регламентное сервисное обслуживание и калибровка: Dräger Medical Oxylog 2000 Plus

Dräger Medical Oxylog 2000 plus Technical Documentation Manual

Dräger Medical Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support. It offers a modern design, many ventilation modes and comprehensive monitoring parameters with high-resolution color display for optimal readability.

Technical Documentation
Oxylog 2000 plus Emergency and Transport Ventilator

WARNING! The proper servicing and testing of this device requires a full understanding of this Technical Documentation. Carefully read this Technical Documentation and any applicable Instructions for Use prior to any use of the device.

Revision 1.0 5503.320 9036363

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Contents

Abbreviations 1
Explanation 6
General 1
Symbols and Definitions 8
Notes 8
Function Description 1
General 10
Functional principle 10
Pneumatic assembly 11
3.1 Inlet ....................................................................................................................................... 11
3.2 Restrictor .............................................................................................................................. 11
3.3 Sensors and safety functions ............................................................................................... 11
3.4 PEEP valve .......................................................................................................................... 12
3.5 Ambient pressure conditions ................................................................................................ 13
Electronics 13
4.1 Charging Circuit PCB ........................................................................................................... 13
4.2 Sensor PCB .......................................................................................................................... 14
4.3 Front membrane cover ......................................................................................................... 14
4.4 Control PCB ......................................................................................................................... 14
Maintenance Procedures 1
Replacing the replaceable battery 16
Replacing the filter element 17
Schematics and Diagrams 1
General 20
Annex
Parts Catalog
Test instructions

This chapter contains a list of the abbreviations used in this manual.

Abbreviations

Oxylog 2000 plus

1 Explanation

Abbreviation Explanation
BTPS English acronym for “Body Temperature, Pressure, Saturated” (current conditions in the patient's lung, i.e. body temperature 37 °C, ambient pressure, water-vapor saturated gas).
DC English acronym for “Direct Current”.
EEPROM English acronym for “Electrically Erasable Programmable Read-Only Memory”.
EL display Electroluminescence display.
EPROM English acronym for “Erasable Programmable Read- Only Memory”.
LED English acronym for “Light Emitting Diode”.
MV English acronym for “Minute Volume”.
PC English acronym for “Personal Computer”.
PEEP English acronym for “Positive End Expiratory Pressure”.
RAM English acronym for “Random Access Memory”.
VC-CMV English acronym for the ventilation mode “Volume Control - Controlled Mandatory Ventilation”.
VC-SIMV English acronym for the ventilation mode “Volume Control - Synchronized Intermittent Mandatory Ventilation”.
VT English acronym for “Tidal Volume”.

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This chapter contains general notes and definitions that are important for the use of this manual.

General

Oxylog 2000 plus

1 Symbols and 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, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property.
NOTE A NOTE provides additional information intended to avoid inconvenience during operation or servicing of the equipment.

Definitions:
Inspection = examination of actual condition
Maintenance = measures to maintain specified condition
Repair = measures to restore specified condition
Servicing = inspection, maintenance, and repair

Notes

This Technical Documentation conforms to the IEC 6061-1 standard. Read each step in every procedure thoroughly before beginning any test. Always use the proper tools and specified test equipment.

If you deviate from the instructions and/or recommendations in this Technical Documentation, the equipment may operate improperly or unsafely, or the equipment could be damaged.

Dräger recommends that only Dräger supplied repair parts be used for maintenance. Otherwise the correct functioning of the device may be compromised.

The maintenance procedures described in this Technical Documentation may be performed by properly trained service personnel only. These maintenance procedures do not replace inspections and servicing by the manufacturer.

This Technical Documentation is for informational purposes only. Product information contained in this Technical Documentation does not supersede Product information provided in the Instructions for Use enclosed with the product at the time of delivery.

Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany for equipment used or serviced in Germany. Users or technicians in all other countries must verify compliance with local laws or applicable international standards.

If the test values are not met, please contact your local service organization.

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

Function description

Oxylog 2000 plus

1 General

The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards. For use by and under supervision of trained health care professionals.

2 Functional principle

Oxylog 2000 plus primarily comprises the pneumatic components with the connection and metering block and the control and display electronics (Fig. 1). The connection block supplies a constant pressure to the metering block, contains the safety functions such as the emergency air and safety valves, control the pressure (PEEP) during expiration and, together with the ventilation accessories, provides the interface to the patient. The metering block passes defined volumes of gas of approx. 40% or 100% oxygen to the connection block. The control and display electronics evaluate the measurement signals, control the valves and provide the interface to the operator.

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Fig. 1 Functional principle

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Function description

Oxylog 2000 plus

3 Pneumatic assembly

The following description relates to the pneumatics diagram of the Oxylog 2000 plus. The Control PCB evaluates the measurement signals of the sensors and actuates the valves.

3.1 Inlet

The compressed oxygen passes through the filter F1 and the pressure regulator DR to the valves V1 to V3. The pressure regulator regulates the pressure to 3 bar. This is done to attain a stable flow control. The Control PCB monitors this pressure, which is measured with sensor S3.

3.2 Restrictor

Valves V1 to V3 are proportional valves, each delivering a flow proportional to the overall flow of 0 to 35 L/min. The flow sensor S1 measures the delivered flow and the Control PCB corrects the valve operation as necessary. Valve V3 comprises two parallel configured valves, to produce a total flow greater than 100 L/min. With the valve V1 and the ejector E1 ambient air can additionally be drawn in. Valve V1 meters a flow through the ejector. The resultant negative pressure draws ambient air through the filter F2, the flow sensor S2 and the non-return valve V9.

3.3 Sensors and safety functions

Valve V2 adds oxygen to the ambient air depending on the selected O2 concentration (40 or 100%). The proportion of ambient air may be a maximum of 75%. The minimum oxygen concentration may thus be 40%. At flows less than 9 L/min the volume of intake air is so low that an oxygen concentration of 40% is no longer guaranteed. At flows greater than 35 L/min oxygen is added accordingly. An oxygen concentration of 40% is no longer guaranteed. In a flow range from 9 to 35 L/min an oxygen concentration of 40% or 100% can be set. The non-return valve V9 prevents oxygen escaping into the ambient air. L1 prevents swirling, and ensures a uniform oxygen concentration.

The flow sensor S1 measures the inspiratory flow inside the unit and the Control PCB corrects the operation of valves V1 to V3 as necessary based on the measured value. The safety valve SV opens at a pressure greater than 80 mbar, to prevent the patient from being exposed to high pressure in the event of unit malfunctions. The emergency breathing valve NV allows the patient to breathe spontaneously in case the unit fails. The pressure sensor S4 measures the internal patient pressure inside the unit and the PEEP pressure at the ventilation valve V10. The pressure sensor S6 measures the differential pressure above the flow sensor S8 located close to the patient (Fig. 2). From it, the Control PCB calculates the flow.

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Fig. 2 Functional principle of the external flow sensor

Pressure sensor S5 measures the pressure at the patient. Based on this pressure value, the Control PCB makes calculations including for actuation of the PEEP valve V6. Valves V7 and V8 switch the connections of S6, S5 against atmosphere at cyclic intervals. The Control PCB calibrates the sensors and any offset drift is prevented.

3.4 PEEP valve

The PEEP valve V6 controls the PEEP setting of the ventilation valve V10. The Control PCB actuates a coil which delivers a pressure to a diaphragm. The internal tubing system vents to this pre-set PEEP pressure during expiration. This PEEP pressure also acts on a valve diaphragm in the ventilation valve V10 (Fig. 3/1). On expiration the pre-set PEEP pressure is established at the patient. During expiration an internal flow of 0.5 L/min flows through the PEEP valve V6 to hold the diaphragm of the PEEP valve still and ensure uniform opening of the PEEP valve. During inspiration the PEEP valve V6 is closed by an actuation current of 130 mA.

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Fig. 3 Ventilation valve

3.5 Ambient pressure conditions

Oxylog 2000 plus meters the tidal volume under BTPS conditions. Sensors S7 and S9 measure the ambient pressure. S5 measures the current pressure level in the lung. In this way the Control PCB can balance fluctuating ambient pressure and the BTPS conditions (Body Temperature, Pressure, Saturated. Measurements referred to conditions of the patient's lung, body temperature 37 °C, ambient pressure, water vapor saturated gas).

4 Electronics

The following description relates to the Electronics block diagram and represents only the principle of operation. The connections of the individual modules are only indicated indirectly, and are made by cable harnesses, connectors and the conductors on the individual PCBs.

4.1 Charging Circuit PCB

The Charging Circuit PCB controls charging of the internal replaceable battery and selection of the voltage supply (mains, on-board system or internal battery). The Charging Circuit PCB accommodates the input for the external voltage supply. The input is isolated from the remaining electronics by a protective circuit. The Charging Circuit PCB directly activates the power indicator LEDs. The LEDs are located on the front membrane cover. The Charging Circuit PCB has its own processor system, and thus its own software. This software is also located on the Control PCB, and is loaded from there onto the Charging Circuit PCB. The internal replaceable battery has various dummy resistors, depending on the type used. The Charging Circuit PCB detects on the basis of the resistor which type is fitted (nickel metal hydride or lithium ion). The temperature and charge capacity of the internal replaceable battery is determined by the battery itself. These data are transmitted from the Charging Circuit PCB to the Control PCB.

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4.2 Sensor PCB

The Sensor PCB holds all the pressure sensors of the pneumatic system and the internal temperature gauge. The Sensor PCB is the interface for pressure measurement and valve actuation between the pneumatic and electronic systems.

4.3 Front membrane cover

On the front membrane cover are the keys, the LEDs and the rotary knob. Together with the display, the rotary knob and the potentiometers, the front membrane cover is the interface between the unit and the operator. The display is an EL display. EL stands for electroluminescent.

4.4 Control PCB

The Control PCB holds the electronic ON/OFF switch components, the voltage generation of the individual internal operating voltages, and the microprocessor system for control and monitoring of ventilation. The electronic ON/OFF circuit is directly controlled (switched on or off) by the ON/OFF switch on the device. If the device is ON and the power fails, an alarm generator generates an audible alarm signal. A Goldcap capacitor delivers the voltage for the signal. The voltage generator generates the various operating voltages from the supply voltage. For example the +5 V for the microprocessor. The microprocessor system comprises the microcontroller, an EEPROM, a flash EPROM, a RAM, and a real-time clock (RTC). The EEPROM holds the calibration data, software options, ID number, unit and service operating hours and the start-up conditions. The flash EPROM holds the medical device software and the software for the Charging Circuit PCB. The real-time clock generates the time and date. The real-time clock's RAM also holds the logs. The microprocessor system evaluates the measurement signals from the sensors, the settings of the potentiometers and the rotary knob and operates the valves and the display accordingly. On a change of software the unit no longer needs to be opened. The infrared interface transfers the data from the PC/laptop to the microcontroller and vice versa.

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This chapter describes the measures required to maintain the specified condition of the device.

Maintenance Procedures

Oxylog 2000 plus

1 Replacing the replaceable battery

1. Slacken the screw Fig. 1/1 of the battery compartment cover anti-clockwise until the cover can be opened.
2. Fold the cover Fig. 1/2 down.
3. Pull the replaceable battery Fig. 1/3 forward by its tab and withdraw it.

Fig. 1 Removing the replaceable battery

4. Press the button on the new replaceable battery and check the charge. The LEDs on the replaceable battery indicate the charge condition in percent.
5. Charge the replaceable battery as necessary.
The replaceable battery can be charged by the battery charger station or by the external power supply in the Oxylog 2000 plus.
6. Fit the replaceable battery.
7. Switch on the Oxylog 2000 plus and check the battery capacity indicated on the display.

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Fig. 2 Removing the filter element

Note fitting position of filter element.

3. Remove the filter element.
4. Install the new filter element.
5. Carry out a unit test.
6. Place the fully functional unit at the user's/owner's disposal.

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This chapter contains schematics and diagrams that can be of help when servicing the device.

Schematics and Diagrams

Oxylog 2000 plus

1 General

This section presents the diagrams and overviews of the Oxylog 2000 plus, such as the pneumatic components diagram and the block diagram of the electronics. These schematics and diagrams are partly used as reference to the function description.

Fig. 1 Overview; for legend see Table 1

Table 1 Legend Fig. 1

Item Designation
1 Front panel with potentiometers, rotary knob, membrane keypad, and insert strip
2 Signal generator
3 Loudspeaker
4 Display
5 Control PCB (see also Fig. 6)
6 Cover plate for pneumatic assembly
7 Pneumatic assembly and Sensor PCB (see also Fig. 3)
8 Handle
9 Filter element to filter the ambient air intake
10 Charging Circuit PCB
11 Rear panel
12 Battery compartment cover
13 Replaceable battery

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Fig. 2 Pneumatic components diagram, for legend, see Table 2

Table 2 Legend Fig. 2 and Fig. 3

Item Designation
1 Connection block
2 Metering block
DR Pressure regulator
E1 Ejector
F1 Filter in O2 compressed gas connection port
F2 Filter for intake air
L1 L1 makes sure there is an even flow
NV Emergency-air valve
S1 Flow sensor to measure internal inspiratory flow
S2 Flow sensor to measure the ambient air intake
S3 Pressure sensor (Pv) to measure supply pressure for valves V1 to V3
S4 Pressure sensor (Pint) to measure unit-internal patient pressure
S5 Pressure sensor (Paw) to measure pressure close to patient
S6 Pressure sensor (delta P) to measure differential pressure at external flow sensor
S7 and S9 Pressure sensors to measure ambient pressure
S8 External flow sensor
SV Safety valve
V1 to V3 Metering valves
V10 Ventilation valve
V6 PEEP valve
V7 and V8 Switching valves to calibrate pressure sensors S5 and S6
V9 Non-return valve

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Fig. 3 Overview of pneumatic components, for legend see Table 2

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Fig. 4 Tubing diagram, for legend, see Table 3

Table 3 Legend Fig. 4

Item Designation
1 Sensor PCB
2 Connection block
3 Metering block
4 Tube 4x1 PAE not colored (nc)
5 Tube 2x1.5 Si not colored (nc)
6 Tube 2x1 Si blue (bu), red (rd), orange (og)

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Fig. 5 Electronics block diagram

Fig. 6 Control PCB, for legend, see Table 4

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Table 4 Legend Fig. 6

Item Designation
1 EEPROM
2 Goldcap capacitor
3 Microcontroller
4 Real-time clock with battery
A Control PCB mounting screws
X120 Connection to signal generator
X200 Connection to Sensor PCB
X220 Connection to potentiometers
X270 Connection to loudspeaker
X312 Jumper to trigger a reset
X400 Connection to flow sensor S1
X440 Connection to flow sensor S2
X609 Jumper to perform bootstrap download
X665 Connection to rotary encoder
X700 Connection to Charging Circuit PCB
X730 Connection to front membrane (keys).
X740 Connection to front membrane (LEDs)
X760 Connection to display
X790 Pin strip for bootstrap download

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This chapter contains a list of the device's orderable parts.

Parts catalog

Oxylog 2000 plus

Revision: 00 2008-04-28

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Product concerned

Item No. Order No. Description Qty. Qty.unit Remark
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Set, 2-yearly

1 2M86341 Filter Mat 1.000 St
2 2M86733 Battery Lithium-Ionen 1.000 St

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Accessories/Consumables

1824481 Power Cable CE,3m,10A,C13L,bk 1.000 St
1868160 Cable TH/BR,3m,C13,black RoHS 1.000 St
1844342 Power cable DK, 3 m, 10 A 1.000 St
1844369 Power cable Great Britian 3m black 1.000 St
1844377 POWERCORD CH 3M 1.000 St
1851705 Cable Australia,3m,10A,C13 1.000 St
1859706 Power cable 10A,3m,black,China 1.000 St
2M86729 Battery Charger 1.000 St
2M86730 DC/DC Converter 1.000 St
2M86731 Battery Lithium-Ionen 1.000 St
ME05133 Conversion kit reusable 1.000 St
ME05134 Conversion Kit Disposable 1.000 St
5703307 Carrying Belt 1.000 St
5704216 All-round Wall Holder 1.000 St
5704217 Wall Holder Adaptation Plate 1.000 St
5704218 Equipment holder 1.000 St
2M86900 Equipment Holder USA 1.000 St
5704640 All round Wall Holder USA 1.000 St

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5704441 Hose O2 DISS-DISS gr 1,5m 1.000 St
5704447 Hose O2 DISS-DISS gr 3 m 1.000 St
5704440 Hose O2 DISS-DISS gr 1,5m spr 1.000 St
5704442 Hose O2 DISS-DISS gr 3 m spr 1.000 St
2M86975 Carrying System 1.000 St
CP-Catalog Accesso./Consumabl. 1.000 St

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Carrying System

2 8412716 O2-Connector Tube 0,5m 1.000 St

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5 5704500 Gas Supply System 1.000 St
6 5704216 All-round Wall Holder 1.000 St

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This chapter contains the measures required to determine the actual condition of the device.

Test instructions

Oxylog 2000 plus

The procedures described in this Test List can be carried out using commercially available test equipment and tools; however, this Test List does not replace inspections and maintenance by the manufacturer.

General: All results must be documented in the Test Report.

Revision 1.0 1 of 20

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1 Device configuration

1.1 Oxylog 2000 plus device configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.1.1 Serial number of the Oxylog (if not otherwise recorded) .....................................................................6
1.1.2 Serial number of the power supply unit (if not otherwise recorded) ....................................................6
1.1.3 Software version ..................................................................................................................................6
2 Electrical safety

2.1 Electrical safety according to VDE 0751/IEC 60601-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
2.1.1 Oxylog 2000 plus - not applicable - .....................................................................................................8
2.1.2 Power supply unit visual check ............................................................................................................8
2.1.3 Protective earth conductor of power supply cord ................................................................................8
3 Function and condition test

3.1 Condition test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
3.1.1 Labels and Instructions for Use .........................................................................................................10
3.1.2 Basic unit, outside .............................................................................................................................10
3.1.3 Carrier system and accessories ........................................................................................................10
3.2 Basic unit function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
3.2.1 Unit test .............................................................................................................................................11
3.2.2 Buttons and potentiometer ................................................................................................................11
3.2.3 Loudspeaker, buzzer, LEDs and display ...........................................................................................11
3.2.4 Voltage supply ...................................................................................................................................11
3.2.5 Supply pressure/emergency air valve ...............................................................................................12
3.2.6 Safety valve .......................................................................................................................................13
3.3 Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
3.3.1 Volume-controlled ventilation ............................................................................................................14
3.3.2 Trigger function ..................................................................................................................................14
3.4 Device handover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
4 Test equipment

4.1 Test equipment list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
5 Annex

5.1 Accessing service mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
5.1.1 Accessing the Customer Service Mode .............................................................................................20

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