Dräger Oxylog 2000 Technical Manual

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.
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Contents
Abbreviations
1 Explanation 6
General
1 Symbols and Definitions 8
2 Notes 8
Function Description
1 General 10
2 Functional principle 10
3 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
4 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
2 Replacing the filter element 17
Schematics and Diagrams
1 General 20
Annex
Parts Catalog
Test instructions
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Contents
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Abbreviations
This chapter contains a list of the abbreviations used in this
manual.
5
Abbreviations Oxylog 2000 plus
1 Explanation
Abbreviation Explanation
BTPS English acronym for “Body Temperature, Pressure, Sat-
urated” (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 Programma-
ble 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 Con-
trol - Controlled Mandatory Ventilation”.
VC-SIMV English acronym for the ventilation mode “Volume Con-
trol - Synchronized Intermittent Mandatory Ventilation”.
VT English acronym for “Tidal Volume”.
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General
This chapter contains general notes and definitions that are
important for the use of this manual.
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General Oxylog 2000 plus
1 Symbols and Defini-
tions
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
2Notes
This Technical Documentation conforms to the IEC 60601-1 standard.
Read each step in every procedure thoroughly before beginning any test. Always use the proper tools and specified test equipment.
CAUTION
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.
CAUTION
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.
NOTE
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.
NOTE
If the test values are not met, please contact your local service organiza­tion.
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Function Description
This chapter contains descriptions of the device's technical
functions.
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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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Oxylog 2000 plus Function description
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 regu-
lator 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.
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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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Function description Oxylog 2000 plus
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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Oxylog 2000 plus Function description
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 repre-
sents 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.
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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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Function description Oxylog 2000 plus
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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Maintenance Procedures
This chapter describes the measures required to maintain
the specified condition of the device.
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Maintenance procedures Oxylog 2000 plus
1 Replacing the
replaceable battery
1. Slacken the screw Fig. 1/1 of the battery compartment cover anti-clock- wise 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.
NOTE
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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Oxylog 2000 plus Maintenance procedures
2 Replacing the filter
element
1. Switch off the device.
2. Remove screws Fig. 2.
Fig. 2 Removing the filter element
NOTE
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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Maintenance procedures Oxylog 2000 plus
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