Babylog 8000, 8000SC and 8000 plus Technical Documentation Rev 10.0

Copyright by Dräger Medical AG & Co. KGaA, Lübeck, Germany. No reproduction allowed for commercial purposes. Read and understand the Instructions for Use/Operator’s Manual. This Technical Documentation does not replace the Instructions for Use/Operator’s Manual. The warranty and liability conditions of the general terms and conditions for business transactions of Dräger Medical AG & Co. KGaA are not extended by this Technical Documentation. Observe all applicable technical laws and regulations. Insofar as reference is made to laws, regulations or standards, these are based on the legal system of the Federal Republic of Germany. Observe the laws and regulations applicable in your country.

Contents General 1

Notes 1.1

9

Symbols and Definitions ... 9

Function Description 1

2

3

4

General 1.1

Ventilation Modes ... 13

1.2

Additional Functions ... 13

1.3

Monitoring ... 13

Block Diagrams

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14

2.1

Block Diagram of the Components in Babylog 8000/Babylog 8000 SC with LC Display 14

2.2

Block Diagram of the Components in Babylog 8000/Babylog 8000 plus with EL Display 15

2.3

Block Diagram of the Babylog 8000/ Babylog 8000 plus/Babylog 8000 SC ... 16

Airway Monitoring

17

3.1

Airway Pressure ... 17

3.2

Trigger Signal ... 17

3.3

Measurement of the Fraction of Inspired O2 ... 17

3.4

Patient Flow (Babylog 8000/Babylog 8000 plus) ... 18

Monitoring Functions 4.1

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19

Fraction of inspired O2 (FiO2) ... 19 4.1.1

O2 Measurement ... 19

4.1.2

O2 Calibration ... 19

4.2

Gas Supplies ... 20

4.3

Airway Pressure Monitoring ... 20

4.4

Disconnect Monitoring ... 20

4.5

Overpressure and Low Pressure Alarms ... 21

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Contents

I

Contents

4.6

4.5.1

Babylog 8000 up to Software Version 3.0 ... 21

4.5.2

Dynamic Stenosis Limit ... 21

Minute Volume Monitoring (Babylog 8000/Babylog 8000 plus) ... 23 4.6.1

Babylog 8000 with Software Versions 2 and 3 ... 23

4.6.2

Babylog 8000 Software with Version 4.0 or Higher ... 23

4.6.3

Babylog 8000 plus ... 23

4.7

Audible Alarm Generator Monitoring ... 23

4.8

Operating Voltage Monitoring ... 23

4.9

Rotary Potentiometer Monitoring ... 23

4.10 ROM Test ... 24 4.11 RAM Test ... 24 4.12 Temperature Monitoring ...24 4.13 Relay and Valve Monitoring ... 24 4.14 Battery Monitoring ... 24 4.15 Flow Measurement Monitoring (Babylog 8000/ Babylog 8000 plus) ... 24 5

6

Alarms, Cautions and Advisory Messages 5.1

Message Display ... 25

5.2

Display and Menu ... 25 5.2.1

Babylog 8000/Babylog 8000 SC with LC Display ... 26

5.2.2

Babylog 8000/Babylog 8000 plus with EL Display ... 26

Function of the Control Elements 6.1

27

Potentiometers (Rotary Knobs) ... 27 Fraction of inspired O2 (O2 vol.%) ... 27

6.1.2

Inspiratory time (TI) ... 27

6.1.3

Expiratory time (TE) ... 27

6.1.4

Inspiratory flow (Insp. Flow) ... 27

6.1.5

Inspiratory pressure limit (Pinsp) ... 27

6.1.6

PEEP/CPAP ... 27

Keys ... 28

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6.1.1

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6.2

II

25

Contents

7

8

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9

10

6.2.1

CPAP ... 28

6.2.2

IPPV/IMV (CMV) (up to software version 4.n) ... 28

6.2.3

Man. Insp. ... 28

6.2.4

2-min Silence ... 28

6.2.5

Reset/Check (OK) ... 28

6.2.6

Backlight On/Off (Babylog 8000/8000 SC with LC Display) ... 28

6.2.7

"Cal. Config." (as of software version 5.n) ... 29

6.2.8

Keys ... 29

Cold Start/Warm Start Behavior

30

7.1

Cold-Start Behavior ... 30

7.2

Warm-Start Behavior ... 30

Description of Pneumatic Functions

31

8.1

Gas Supplies ... 31

8.2

Controlled Ventilation ... 32 8.2.1

Inspiration ... 32

8.2.2

Expiration ... 33

8.2.3

PEEP ... 33

8.2.4

CPAP ... 33

Measurement of the Ventilation Parameters

34

9.1

O2 Measurement ... 34

9.2

Measurement of the Airway Pressure ... 34

9.3

Pneumatics Control PCB ... 35

9.4

Pneumatics Analog PCB ... 36

9.5

Patient System Heater ... 37

9.6

Pressure Sensor Base PCB ... 37

9.7

O2 Amplifier PCB ... 37

Components of the Electronic Assembly

38

10.1 Power Supply Unit ... 38

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Contents

III

Contents 10.2 Motherboard PCB ... 38 10.3 CPU 68000 PCB ... 39 10.4 I/O PCB ... 40 10.5 Flow PCB (Babylog 8000/Babylog 8000 plus) (optional) ... 41 10.6 Monitoring PCB ... 42 10.6.1

Measurement of Analog Signals ... 42

10.6.2

Measurement of Digital Inputs ... 42

10.6.3

Measurement of Digital Outputs ... 42

10.7 Front Adapter PCB ... 45 10.8 Front Controller PCB (Babylog 8000/Babylog 8000 SC with LC Display) 46 10.9 Front PCB (Babylog 8000/Babylog 8000 plus with EL Display) ... 47 10.10Display PCB (Babylog 8000/Babylog 8000 SC with LC Display) ... 48 10.11 EL display (Babylog 8000/Babylog 8000 plus with EL Display) ... 49 10.12Potentiometer Field ... 50 10.13Display Field ... 50 10.14Communication PCB ... 51 10.15Interface PCB ... 52 11

Sensors

53

11.1 Pressure Sensors ... 53 11.2 Y-Piece with Flow Sensor (Babylog 8000/Babylog 8000 plus) ... 53 11.2.1

Measuring Principle of the Flow Measuring Bridge ... 54

11.3 O2 Sensor ... 55

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IV

Contents Replacing Non Repairable Items 1

Important Information

59

2

Cleaning or Replacing the Cooling Air Filter Every 4 Weeks

60

3

Replacing the O2 Sensor Capsule

61

3.1

O2 Sensor Calibration ... 61

3.2

Calibrating the O2 Sensor After Replacement ... 61

3.3

Disposing of the O2 Sensor Capsule ... 63

4

Replacing the Lip Seals Every 2 Years

64

5

Replacing the NiCd Battery (Power Failure Alarm) Every 2 Years

65

6

Replacing the Pressure Reducer Every 6 Years

67

Schematics and diagrams 1

Schematics and Diagrams

77

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Error List 1

Error messages

91

2

List of device error messages

92

Annex Spare parts list

97

Test List

97

Technical Information according to EMC standard IEC/EN 60601-1-2:2001

97

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Contents

V

Contents

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Contents

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VI

General

7

Babylog 8000 1

Notes

General This Technical Documentation/Service Manual conforms to the International Standard IEC 60601-1. 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/Service Manual, the equipment may operate improperly or unsafely, or the equipment could be damaged. Use only original Dräger parts and supplies. The maintenance procedures described in this Technical Documentation/Service Manual may be performed by qualified service personnel only. These maintenance procedures do not replace inspections and servicing by Dräger Medical AG & Co. KGaA.

Strictly follow the Instructions for Use/Operating Instructions! This Technical Documentation does not replace the Instructions for Use/Operating Instructions. Any use of the product requires full understanding and strict observation of the product-specific Instructions for Use/Operating Instructions.

Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany.

1.1

Symbols and Definitions This symbol indicates a warning.

This symbol is used to alert against unsafe practices when handling electrostatic sensitive devices (ESD). All rights reserved. Copyright reserved.

Version 1.0_ Released_Printed on_18.05.05_GBK61733XXA01.fm

This symbol indicates tips and useful information.

Definitions according to German standard DIN 31051:

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Inspection

= examination of actual condition

Maintenance

= measures to maintain specified condition

Repair

= measures to restore specified condition

Servicing

= inspection, maintenance, and repair

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9

10

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General Babylog 8000

Function Description

11

Function description 1

Babylog 8000

General

Babylog 8000/Babylog 8000 plus has a flow measurement function. The Babylog 8000 SC can be upgraded to a Babylog 8000 using the "flow measurement conversion kit.

1.1

Ventilation Modes

Babylog 8000/Babylog 8000 plus/8000 SC provides the following ventilation modes:  IPPV (Intermittent Positive Pressure Ventilation), controlled and assisted constant-volume ventilation  SIPPV (Synchronized Intermittent Positive Pressure Ventilation), synchronized controlled and assisted constant-volume ventilation  IMV (Intermittent Mandatory Ventilation)  SIMV (Synchronized Intermittent Mandatory Ventilation) weaning method for spontaneously breathing patients  CPAP (Continuous Positive Airway Pressure) spontaneous breathing with positive airway pressure  PSV (Pressure Support Ventilation) (optional as of software version 5.n)

1.2

Additional Functions

Babylog 8000/Babylog 8000 plus/8000 SC provides the following (optional) additional functions:  High-frequency ventilation (HV) (as of software version 4.n)  Volume guarantee (VG) (as of software version 5.n)

1.3

Monitoring

Babylog 8000/Babylog 8000 plus/8000 SC has integrated monitoring functions for:  Fraction of inspired O2 (FiO2)  Airway pressure (Paw)

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 Flow ( ) (Babylog 8000/Babylog 8000 plus)  Minute volume (MV)  Tidal volume (VT)

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Function description

Babylog 8000

2

Block Diagrams

2.1

Block Diagram of the Components in Babylog 8000/Babylog 8000 SC with LC Display

Fan

RS232 PCB

O2 sensor

Pressure sensor PCB

Flow connector

Battery

O2 ampilfier

Loud speaker

Vol.% O2

pressure AIR pressure O2 Pinsp Pexsp

Elektronic unit

Flow PCB (not 8000SC)

Pneumatic driver PCB

I/O PCB

Power cord

Power supply PCB

Patiententeilheating

Monitoring PCB

PEEP/PIP

Watch dog PCB

Valves

Communication PCB

Pneumatic Analog PCB

LP Mutterboard

CPU 68000 PCB

Frontadapter PCB

Pneumatic unit

Fig. 1: Block diagram of the Babylog 8000/8000 SC with LC display

14

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LC display

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Potentiometer field

Display PCB

Front

Monitoring field

Frontcontroller PCB

Function description Block Diagram of the Components in Babylog 8000/Babylog 8000 plus with EL Display

Pressure sensor PCB

Flow connector

Battery

Fan

RS232 PCB

O2 sensor

Loud speaker

Vol.% O2

pressure AIR pressure O2 Pinsp Pexsp

Elektronic unit

O2 amplifier

2.2

Babylog 8000

Pneumatic amplifier PCB

Flow PCB

I/O PCB

Power cord

Power supply PCB

Patient unit heating

Monitoring PCB

PEEP/PIP

Watch dog PCB

Valves

Ccommunication PCB

Pneumatic Analog PCB

LP Mutterboard

CPU 68000 PCB

Frontadapter PCB

Pneumatic unit

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Potentiometer field

ELD converter

Front

Monitoring field

Front PCB

EL display

Fig. 2: Block diagram of the Babylog 8000/Babylog 8000 plus with EL display

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Function description 2.3

Babylog 8000

Block Diagram of the Babylog 8000/ Babylog 8000 plus/Babylog 8000 SC

LC display

2 red Alarm LEDs

EL display (Babylog 8000/ Babylog 8000 plus)

LEDs

Potentiometer keys

Front Communication

Battery CPU (Master)

Monitoring

Reserve horn

Flow Babylog 8000 Babylog 8000 plus I/O E

E V

V

Flow sensor E

E

E

E

E

P

P

P

P

PAIR

PO2

Pexsp

Pinsp

E O

O

O2-Sensor

+27 V

+5 V

& 24 Ventile Valve amplifier PEEP/PIP valve Valve monitoring

16

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Fig. 3: Block Diagram of the Babylog 8000/Babylog 8000 plus/Babylog 8000 SC

Function description 3

Babylog 8000

Airway Monitoring

In the ventilation modes IPPV/IMV and CPAP, the airway pressure (Paw), the flow at the Y-piece VT (Babylog 8000/Babylog 8000 plus), and the fraction of inspired O2 (FiO2) are measured. Depending on the selected mode and the menu settings, the parameters are monitored and displayed on the screen. Pressure and flow curves as well as their storage can be displayed graphically on the LC display or EL display. In all ventilation modes, the chronological sequence of the airway pressure (Paw) is displayed in the LED bargraph.

3.1

Airway Pressure

Two internal pressure sensors measure the pressure at the inspiratory outlet (Pinsp) and the pressure at the expiratory inlet (Pexp). The airway pressure is calculated as follows: Paw = Pinsp – 0.7 (Pinsp – Pexp) The following pressures are calculated from the Paw pressure signal:  Peak pressure (Peak)  Mean airway pressure (Pmean)  Positive end-expiratory pressure (PEEP) The peak pressure is the maximum positive pressure of the most recent respiratory cycle. After 30 s, at the latest, a new respiratory cycle must be recognized and a new measured value for the peak pressure must be generated, otherwise the current measured value is no longer valid and is removed from the display. The mean airway pressure is the initial value of a software digital filter. The PEEP is either the pressure value during the expiratory phase at a zero expiratory flow or the last measured value before the next inspiration. Like the peak pressure, the PEEP is no longer valid after 30 s and is removed from the display if a new measured value is not generated within the 30-s period.

3.2

Trigger Signal

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In order to generate a trigger signal, the inspiratory flow must be integrated during spontaneous breathing and compared to the adjustable trigger threshold.

3.3

Measurement of the Fraction of Inspired O2

A O2 sensor in the inspiration line measures the O2 content of the respiratory gas. Calibration data of the O2 sensor is maintained after switching off the Babylog. If the Babylog has been out of operation for more than 24 hours, a calibration will automatically be carried out upon power-on. The operator may also initiate a calibration manually, e.g. as required after replacing an O2 sensor. Dräger Medical AG & Co. KGaA

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Function description

Babylog 8000

A two-step calibration with 21% and 100% O2 is always carried out in order to achieve a higher measurement accuracy over the whole concentration range and/or to be able to recognize a spent sensor cell. The calibration procedure is described under section "4 Monitoring Functions". If the O2 measurement fails, the Babylog generates an alarm. This alarm status is shown in the status field of the screen by the flashing indication "FiO2".

3.4

Patient Flow (Babylog 8000/Babylog 8000 plus)

A direction-sensitive hot-wire flowmeter integrated into the Y-piece measures the inspiratory and expiratory flows through the tube. This measurement function must be reactivated each time after switching on Babylog 8000/Babylog 8000 plus and after each replacement of the sensor by calibrating the sensor. The flow signal is used to calculate the following values:  Tidal volume (VT)  Minute volume (MV)  Percentage of the MV uptake through spontaneous breathing  Tube leakage The tidal volume is the expiratory flow signal applied between two breathing phase cycles. Unlike the tidal volume, the minute volume is not related to a respiratory cycle. In the same way the inspiratory MV is calculated for leak rate detection. The expiratory minute volume is displayed. In addition to the complete minute volume, Babylog also calculates the expiratory minute volume uptake through spontaneous breathing. Babylog calculates the percentage by comparing the total minute volume and the minute volume uptake through spontaneous breathing: spont. = (MVspontaneous/MV) * 100% The leakage at the tube can be estimated by comparing the inspiratory and the expiratory minute volume. The leakage at the tube L is calculated as follows:

All measured values derived from the patient flow become valid only after successful calibration of the flow sensor. If the flow sensor or the measuring electronics fails, an alarm is generated. However, Babylog can still be used without the functions depending on the flow measurement. This alarm status is shown in the status field of the screen by the flashing indication "flow".

18

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The respiratory rate f is measured through the inspiratory respiratory phase cycles.

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L= (MVinsp _ MVexp)/(MVinsp + MVexp) * 100.

Function description 4

Babylog 8000

Monitoring Functions

The system checks whether limit values are kept and all functions are ok. If a function fails or if the limit values are not met, Babylog will generate an alarm.

4.1

Fraction of inspired O2 (FiO2)

4.1.1

O2 Measurement

The measured O2 value is checked against upper and lower limit values. The alarm limits are automatically set at ±4 vol.% below the set FiO2value. A time delay makes sure no alarm is activated when the set value (O2) is changed or when the O2 sensor is calibrated. The absolute sensor voltages are checked. The differential voltage between the two sensor cells must be lower than (U1 + U2)/8 +1 mV. The output voltage of each individual cell must be between 9.5 mV and 123.6 mV.

4.1.2

O2 Calibration

The O2 sensor is either automatically calibrated 24 hours after the last calibration or manually after selection from the mode menu. If the O2 sensor is replaced during operation the new O2 sensor will be calibrated automatically. However, Babylog cannot detect a sensor replacement if the unit is switched off. In this particular case, the operator has to calibrate the new O2 sensor manually. By switching over a valve the sensor is separated from the respiratory gas flow and purged with the calibration gas (O2). This leads to a change in concentration at the O2 sensor. This change in concentration allows the Babylog to recognize the activation of the calibration valve. The calibration valve is deactivated as soon as the calibration is completed.

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A two-step calibration with 21% O2 and 100% O2 is carried out in order to achieve a higher measurement accuracy over the whole concentration range and to be able to recognize a spent sensor cell. During the calibration procedure the microprocessor system processes (synchronizes) one of the two O2 sensor channels. The O2 channels are then submitted to a specific sequence of states controlled by one of the microprocessor systems and monitored for correct sequence and maximum period by the other. For instance, searching of the calibration values for 21% or 100% must not last longer than 3.5 minutes each. The calibration value for 21% must be between 9.2 mV and 26 mV, and for 100% between 43.6 mV and 123.6 mV; this applies to both channels. The zero voltage resulting from both values must be between –6 mV and +6 mV. After calibration is completed, the software checks whether the limit values respond correctly. Calibration stops if a control gas fails.

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Function description 4.2

Babylog 8000

Gas Supplies

The current measured values of the O2 and AIR gas supplies are considered when the valve bank is adjusted. The inlet pressure for O2 and AIR is 1.7 bar. If the pressure falls below the limit value, a visible and audible alarm is generated. The operator is informed about the cause of the alarm by a plain text message on the display. If the adjusted O2 concentration is 21% or 100%, only an advisory message (no alarm) is displayed if the non-added gas type fails. If the pressure exceeds the limit value, the safety venting mechanism is activated and the continuous flow is switched off. The Babylog will continue to operate only when the pressure has decreased to a permissible level. If the AIR supply fails, the Babylog control switches to O2 supply. If the O2 supply fails, Babylog switches to AIR supply.

4.3

Airway Pressure Monitoring

Depending on the selected mode and parameter settings, a certain airway pressure time profile is set. If the actual profile deviates from the set profile, the Babylog generates an alarm.

4.4

Disconnect Monitoring

Babylog recognizes whether or not the hose system has been connected correctly. If the hose system has been connected incorrectly, the continuous flow is (partly) directed to atmosphere. No pressure builds up in the hose system. Babylog checks during each breathing cycle whether a sufficiently high pressure is available during inspiration. Since inspiratory breaths occur in the mandatory ventilation modes IPPV/IMV, SIPPV and SIMV, this monitoring does not function in the CPAP mode.

Paw Pinsp

Tdis

time Zeit

Tdis > 25 ms ! Pdis = Pinsp - PEEP + PEEP 4

Fig. 4: Disconnect Monitoring

20

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PEEP

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Pdis