Drager Babylog 8000, Babylog 8000SC, Babylog 8000 plus User manual

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Drager Babylog 8000, Babylog 8000SC, Babylog 8000 plus User manual

Technical Service Manual

Babylog 8000/8000SC/8000 plus

Intensive Care Ventilator

Revision 10.0 6173.3 9029623

Emergency Care • Perioperative Care • Critical Care • Perinatal Care • Home Care

Because you care

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

9

 

1.1 Symbols and Definitions .........................................................................................................

9

GBK61733XXIECIVZ.fm 18.05.05

All rights reserved. Copyright reserved.

Function Description

1

General

13

 

1.1

Ventilation Modes .................................................................................................................

13

 

1.2

Additional Functions .............................................................................................................

13

 

1.3

Monitoring .............................................................................................................................

13

2

Block Diagrams

14

2.1Block Diagram of the Components in

Babylog 8000/Babylog 8000 SC with LC Display 14

2.2Block 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

3

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

4

Monitoring Functions

19

 

4.1

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

 

 

4.5.1 Babylog 8000 up to Software Version 3.0 ...............................................................

 

21

 

 

4.5.2

Dynamic Stenosis Limit ...........................................................................................

 

21

 

4.6

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

Alarms, Cautions and Advisory Messages

 

25

 

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

6

Function of the Control Elements

 

27

 

6.1

Potentiometers (Rotary Knobs) ............................................................................................

 

27

 

 

6.1.1 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

 

6.2

Keys

......................................................................................................................................

 

28

 

 

 

 

II

Dräger Medical AG & Co. KGaA

Contents

 

Copyright .reserved rights All

GBK61733XXIECIVZ

.reserved

05.05.18 fm.

GBK61733XXIECIVZ.fm 18.05.05

All rights reserved. Copyright reserved.

 

 

 

 

Contents

 

 

 

 

 

 

 

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

7

Cold Start/Warm Start Behavior

30

 

7.1

Cold-Start Behavior ..............................................................................................................

30

 

7.2

Warm-Start Behavior ............................................................................................................

30

8

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

9

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

10

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

10.8Front 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

Copyright .reserved rights All

GBK61733XXIECIVZ

.reserved

05.05.18 fm.

IV

Dräger Medical AG & Co. KGaA

Contents

GBK61733XXIECIVZ.fm 18.05.05

All rights reserved. Copyright reserved.

 

 

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

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

Dräger Medical AG & Co. KGaA

Contents

V

Contents

Copyright .reserved rights All

GBK61733XXIECIVZ

.reserved

05.05.18 fm.

VI

Dräger Medical AG & Co. KGaA

Contents

General

7

8

Babylog 8000

General

 

 

 

1

Notes

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 Documenta-

 

 

tion/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 Documenta-

 

 

tion/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 Instruc-

 

 

tions for Use/Operating Instructions.

 

 

 

 

 

 

 

 

Unless otherwise stated, reference is made to laws, regulations or stan-

 

 

dards (as amended) applicable in the Federal Republic of Germany.

1.1

Symbols and Defini-

 

 

 

tions

 

This symbol indicates a warning.

Released Printed on 18.05.05 GBK61733XXA01.fm

reserved. Copyright reserved.

Version 1.0_

All rights

This symbol indicates tips and useful information.

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

Definitions according to German standard DIN 31051:

Inspection

= examination of actual condition

Maintenance

= measures to maintain specified condition

Repair

=

measures to restore specified condition

Servicing

=

inspection, maintenance, and repair

Dräger Medical AG & Co. KGaA

6173.3

9

General

Babylog 8000

 

 

reserved. Copyright reserved.

Released Printed on 18.05.05 GBK61733XXA01.fm

All rights

Version 1.0

10

Dräger Medical AG & Co. KGaA

6173.3

Function Description

11

12

Printed on 18.05.05 F61733XXT01.fm

All rights reserved. Copyright reserved.

Function description

Babylog 8000

 

 

1General

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.

1.1Ventilation 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)

1.2Additional 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)

1.3Monitoring

Babylog 8000/Babylog 8000 plus/8000 SC has integrated monitoring functions for:

Fraction of inspired O2 (FiO2)

Airway pressure (Paw)

Flow ( ) (Babylog 8000/Babylog 8000 plus)

Minute volume (MV)

Tidal volume (VT)

Dräger Medical AG & Co. KGaA

6173.3

13

Function description

2Block Diagrams

2.1Block Diagram of the Components in

Babylog 8000/Babylog 8000 SC with LC Display

Elektronic unit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loud speaker

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Battery

 

 

 

 

 

connector

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fan

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Flow

 

 

RS232 PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CPU 68000 PCB

 

 

MutterboardLP

 

 

 

 

 

 

 

 

 

 

 

Watch dog PCB

 

 

Monitoring PCB

 

 

 

 

 

 

Communication PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Flow PCB (not 8000SC)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I/O PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Power supply PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

cord

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Power

 

 

 

Frontadapter PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Frontcontroller

PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Front

Monitoringfield

 

PCBDisplay

 

Potentiometerfield

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

pressure AIR pressure O2 Pinsp Pexsp

 

 

 

 

Vol.% O2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pressure sensor PCB

 

 

 

 

 

 

 

 

 

O2 ampilfier

 

 

 

O2 sensor

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pneumatic Analog

 

 

 

 

 

 

 

 

 

 

PCB

 

 

 

Patiententeil-

heating

 

 

 

 

 

 

 

 

 

 

Pneumatic

driver PCB

 

 

 

PEEP/PIP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Valves

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pneumatic unit

LC display

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

14

Dräger Medical AG & Co. KGaA

6173.3

Babylog 8000

All rights reserved. Copyright reserved.

Printed on 18.05.05 F61733XXT01.fm

Function description

Babylog 8000

 

 

2.2Block Diagram of the Components in

Babylog 8000/Babylog 8000 plus with EL Display

Printed on 18.05.05 F61733XXT01.fm

All rights reserved. Copyright reserved.

Elektronic unit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loud speaker

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Battery

 

 

 

 

 

 

 

 

connector

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fan

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Flow

 

 

RS232 PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CPU 68000 PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MutterboardLP

 

 

Watch dog PCB

 

 

Monitoring PCB

 

 

 

 

 

 

Ccommunication PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Flow PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I/O PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Power supply PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

cord

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Power

 

 

 

 

 

Frontadapter PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Front PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Front

 

Monitoringfield

 

 

converterELD

 

 

Potentiometerfield

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EL display

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

pressure AIR pressure O2 Pinsp Pexsp

 

 

 

 

Vol.% O2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pressure sensor PCB

 

 

 

 

 

 

 

 

 

O2 amplifier

 

 

 

O2 sensor

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pneumatic

Analog PCB

 

 

 

Patient unit

heating

 

 

 

 

 

 

 

 

 

 

amplifier

 

 

 

 

 

PEEP/PIP

 

 

 

 

 

Pneumatic

PCB

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Valves

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pneumatic unit

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

Dräger Medical AG & Co. KGaA

6173.3

15

Function description

Babylog 8000

 

 

2.3Block Diagram of the Babylog 8000/ Babylog 8000 plus/Babylog 8000 SC

 

 

LEDs

 

 

2 red Alarm LEDs

 

 

 

8000/

Babylog8000 plus)

 

 

 

 

 

 

LC display

displayEL (Babylog

 

Potentiometer

 

 

 

 

 

 

 

 

 

 

 

 

 

keys

 

 

 

 

 

 

Front

 

 

 

 

Communication

 

 

 

 

 

 

Battery

 

 

 

 

 

 

 

 

 

 

 

CPU (Master)

 

Monitoring

Reserve

Flow

 

 

 

 

 

 

 

horn

 

 

 

 

 

 

 

 

Babylog 8000

 

 

 

 

 

 

 

Babylog 8000 plus

 

 

 

 

 

 

 

 

 

 

 

I/O

 

 

 

 

E

E

 

 

 

 

 

 

 

V

V

 

 

 

 

 

 

 

Flow sensor

 

 

 

 

 

 

 

 

E

 

E

E

E

E

E

 

 

 

P

P

P

P

O

O

 

 

PAIR

PO2

Pexsp

Pinsp

 

+27 V

+5 V

 

O2-Sensor

 

 

 

 

 

 

 

 

 

&

 

 

 

 

 

 

 

24 Ventile

 

 

 

 

 

Valve amplifier

 

 

 

 

 

 

 

 

 

 

PEEP/PIP valve

 

 

 

 

Valve monitoring

 

 

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

All rights reserved. Copyright reserved.

Printed on 18.05.05 F61733XXT01.fm

16

Dräger Medical AG & Co. KGaA

6173.3

Printed on 18.05.05 F61733XXT01.fm

All rights reserved. Copyright reserved.

Function description

Babylog 8000

 

 

3Airway 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.

3.1Airway 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.

3.2Trigger Signal

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

3.3Measurement 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.

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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".

3.4Patient 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:

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

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

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".

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Function description

Babylog 8000

 

 

4Monitoring 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.

4.1Fraction of inspired O2 (FiO2)

4.1.1O2 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.

4.1.2O2 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.

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

Babylog 8000

 

 

4.2Gas 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.

4.3Airway 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.

4.4Disconnect 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

Pdis

PEEP

time

Zeit

Tdis > 25 ms !

Pdis = Pinsp - PEEP + PEEP

4

Fig. 4: Disconnect Monitoring

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Function description

Babylog 8000

 

 

During each mandatory breath, the level of the disconnection pressure (Pdis) must be exceeded without interruption for at least the disconnection time (Tdis), otherwise an alarm will be generated. Pdis is a function of the settings Pinsp and PEEP. If Pinsp is set considerably higher than the actually attained pressure, the Pdis alarm level likewise increases.

Depending on the flow and the inspiration time settings, the level might not be attained any more. Babylog 8000 generates an alarm even if there is no leakage in the breathing system.

4.5Overpressure and Low Pressure Alarms

During the inspiratory and expiratory phases, the airway pressure (Paw) must not exceed the set pressure limit by more than 10 mbar. If the set pressure limit is exceeded by 10 mbar to 20 mbar, Babylog generates an alarm and, at the same time, reduces the inspiratory breath time. The remaining time is added to the CPAP phase. If the set pressure limit is exceeded by more than 20 mbar, an alarm is activated and the breathing system is vented.

In the CPAP phase, the airway pressure must be r4 mbar of the set PEEP/CPAP. Otherwise an alarm will be generated. If the limit is exceeded by more than 10 mbar, venting is carried out as during the inspiratory phase even if the pressure falls below the absolute level of —2 mbar.

These overpressure and low pressure alarms apply to all ventilation modes.

4.5.1Babylog 8000 up to Software Version 3.0

 

Paw

 

 

 

 

 

 

Stenose 2 (Notentlüftung)

 

 

 

 

10 mbar

 

 

 

 

 

 

Stenose 1 (Inspiration

Exspiration)

 

 

 

10 mbar

 

 

 

 

Pinsp

 

 

 

 

 

 

6 mbar

Entlüftung

 

 

 

 

 

 

 

PEEP

4 mbar

 

 

 

4 mbar

 

 

 

 

 

 

 

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-2 mbar

Zeit

time

 

 

 

 

Fig.

5: Alarms

 

 

 

4.5.2

Dynamic Stenosis Limit

 

 

The dynamic stenosis limit applies to Babylog 8000 units with software version 4.0 and Babylog 8000 SC

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Function description

Babylog 8000

 

 

units with software version 1.0.

The limit value is (Pinsp + 5 mbar).

If this limit value is exceeded, the microprocessor system reads in the actual measured value at 8.3-ms intervals (sampling frequency). The limit value (Pinsp + 5 mbar) is subtracted from each of the actual measured values and entered in a summer.

As soon as the sum of 40 mbar (stenosis 1) is reached, Babylog switches over from inspiratory phase to expiratory phase. If a sum of 70 mbar is reached, despite of the safety measure (stenosis 1), the system will carry out an emergency venting.

Paw

 

 

 

 

Σ = 40 mbar Stenose 1

 

 

Σ = 70 mbar Stenose 2

Pinsp + 5 mbar

 

 

Pinsp

 

 

PEEP

 

 

 

 

time

8,3

8,3

Zeit

 

 

8,3 ms

 

Fig. 6: Dynamic stenosis limit

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Function description

Babylog 8000

 

 

4.6Minute Volume Monitoring (Babylog 8000/Babylog 8000 plus)

The abbreviation MV (for minute volume) is used in the following text.

4.6.1Babylog 8000 with Software Versions 2 and 3

The monitoring menu is used to set the upper and lower alarm limits in the range of 0.03 L/min to

15 L/min. The upper and lower alarm limits are continuously compared with the measured MV value. If the value exceeds the upper alarm limits or falls below the lower alarm limit, the system will activate an alarm. Monitoring is deactivated during calibration of the flow sensor (Babylog 8000) to allow the measured MV value to stabilize. If the flow measurement system fails, the MV monitoring becomes ineffective.

4.6.2Babylog 8000 Software with Version 4.0 or Higher

The monitoring menu is used to set the upper and lower alarm limits in the range of 0.00 L/min to

15 L/min. The upper and lower alarm limits are continuously compared with the measured MV value. If the value exceeds the upper alarm limits or falls below the lower alarm limit, the system will activate an alarm. Monitoring is deactivated during calibration of the flow sensor (Babylog 8000) to allow the measured MV value to stabilize. If the flow measurement system fails, the MV monitoring becomes ineffective.

4.6.3Babylog 8000 plus

Babylog 8000 plus has the software 5.n.

4.7Audible Alarm Generator Monitoring

Babylog has two audible alarm generators (loudspeaker and piezo). During normal operation, the loudspeaker is the audio interface to the operator in the event of alarms. The piezo is only used in the event of power or loudspeaker failure.

At the end of the self-test, the loudspeaker is triggered with a test signal. This test signal is monitored with a microphone. If there is no feedback, Babylog generates error 817.

4.8Operating Voltage Monitoring

During operation, Babylog uses comparators to continuously monitors whether the operating voltages are within specified limits.

When Babylog is switched on, these comparators are checked by a defined changing of the comparator reference voltage.

4.9Rotary Potentiometer Monitoring

Input via rotary potentiometers are processed by two channels. Two microprocessor systems read the input via independent channels and compare the results.

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Function description

Babylog 8000

 

 

4.10ROM Test

During operation, the ROM area used is summed up per byte in a long word variable (long word = 32 bits) which is compared to the check sum stored in the ROM. If the check sums do not match, an error message will be displayed.

4.11RAM Test

During operation the RAM area used is tested with a simple algorithm. By writing 55 hex or AAhex in each cell every bit is checked for settability and resettability.

4.12Temperature Monitoring

A temperature sensor measures the internal temperature of the Babylog. If the temperature is not within the range of –20 °C to 75 °C, an alarm will be generated. If the temperature is too high, a message will inform the operator about a possible failure of the fan.

4.13Relay and Valve Monitoring

An excess-current monitoring function is integrated into the trigger electronics of the valves. The excesscurrent monitoring function is tested after switching on Babylog. If a valve is switched on and operated with the operate voltage for an excessive period of time, the excess-current monitoring function responds within a specific time.

The relay which enables de-energizing of the whole pneumatics assembly is also tested once after poweron. For this purpose, the relay is switched on and off once and the voltages at the relay contact are measured.

During operation, the system checks whether the voltage at the relay contact corresponds to the switching condition.

4.14Battery Monitoring

Babylog has a rechargeable Nicd battery for power failure alarms.

The battery is recharged automatically during operation and its charge checked periodically.

An error message is displayed if the voltage is too high or too low.

4.15Flow Measurement Monitoring (Babylog 8000/ Babylog 8000 plus)

During operation, the flow sensor is checked for correct functioning, freedom of damage and intact contacts.

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Function description

Babylog 8000

 

 

5Alarms, Cautions and Advisory Messages

The alarm structure of the Babylog has three priority levels:

Alarm

-

Immediate action required.

 

 

 

Caution

-

Checking required.

 

 

 

Advisory

-

Information for the operator.

 

 

 

The priority level is indicated by the different tone sequences of the individual audible alarm.

5.1Message Display

When an alarm occurs the corresponding message is displayed as plain text message in a window of the display. The message can be canceled momentarily by pressing the Reset/Check key (or OK key as of software version 5.n). After a certain time out, the message appears again if its cause still exists.

If several alarms have occurred simultaneously, the highest-level alarm is shown on the display. Other alarms will be queued. A message whose cause no longer exist will not be displayed any more.

5.2Display and Menu

The display shows parameters and text messages. The functions of Babylog are set with keys and potentiometers.

The screen is separated into different areas:

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Measurement

Status field

 

 

Grafic field

 

 

 

 

 

field

 

 

 

 

 

 

 

 

 

 

 

 

 

Menü line

Fig. 7: Screen display structure

The graphics field displays real-time curves.

The measured-value field displays monitoring parameter in digital representation.

The status field displays the operating mode and other status information.

The menu line displays the current function of the keys below the screen.

In some cases, the graphics and measured-value fields are combined to form one large field.

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Function description

Babylog 8000

 

 

5.2.1Babylog 8000/Babylog 8000 SC with LC Display

The Monitoring/Mode key and the six keys below the LC display are used for the menu. The Monitoring/Mode key toggles between the two main menus, the monitoring menu and the mode menu. This works from any menu status always reaching the basic status of the other main menu. The function of the keys depends on the respective menu status and is indicated in the menu line of the display by an abbreviation or a symbol.

5.2.2Babylog 8000/Babylog 8000 plus with EL Display

The key "Vent. Mode" activates the menu for the ventilation modes. The key "Vent. Option" activates the menu for the additional functions of the ventilation modes.

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Function description

Babylog 8000

 

 

6Function of the Control Elements

The control elements comprise the potentiometers (rotary knobs) and the keys.

6.1Potentiometers (Rotary Knobs)

6.1.1Fraction of inspired O2 (O2 vol.%)

This potentiometer is used to set the fraction of inspired O2 to a value between 21 vol.% and 100 vol.%. The adjusted value becomes effective immediately.

6.1.2Inspiratory time (TI)

This potentiometer is used to set the inspiratory time to a value between 0.1 s and 2 s. The adjusted value becomes effective at the end of the current respiratory cycle.

6.1.3Expiratory time (TE)

This potentiometer is used to set the expiratory time to a value between 0.2 s and 30 s. The adjusted value becomes effective at the end of the current respiratory cycle.

6.1.4Inspiratory flow (Insp. Flow)

This potentiometer is used to set the inspiratory flow to a value between 1 L/min and 30 L/min. The adjusted value becomes effective immediately.

6.1.5Inspiratory pressure limit (Pinsp)

This potentiometer is used to set the inspiratory pressure limit to a value between 10 mbar and 80 mbar. A value above 40 mbar must be confirmed by pressing the Reset/Check key (or OK key as of software version 5.n). A message is displayed. This pressure limit is also effective when a manual breath is applied. The adjusted value becomes effective immediately.

6.1.6PEEP/CPAP

This potentiometer is used to set the end-expiratory pressure for controlled ventilation or to set the continuous positive airway pressure for spontaneous breathing to a value between 0 mbar and 15 mbar (or 25 mbar as of software version 4.n). A value above 8 mbar must be confirmed by pressing the Reset/Check key (or OK key as of software version 5.n). A message is displayed. The adjusted value becomes effective immediately.

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Function description

Babylog 8000

 

 

6.2Keys

6.2.1CPAP

Pressing this key will activate the CPAP mode. The current respiratory cycle is stopped before a new mode becomes active (for example, IPPV/IMV). This key is protected against unintentional operation by a software-controlled locking. After power-on, Babylog will automatically enter the most recent mode selected.

6.2.2IPPV/IMV (CMV) (up to software version 4.n)

Pressing this key will activate the controlled ventilation mode. This key is protected against unintentional operation by a software-controlled locking. If CPAP was set before, the first mandatory breath is applied after the last expiratory phase has been completed (zero expiratory flow) or after a zero flow has been measured at the Y-piece for one second.

The CPAP and IPPV/IMV keys deactivate each other. The selected ventilation mode is indicated by a green LED on the respective key.

6.2.3Man. Insp.

Pressing this key will apply a breath at the set inspiratory flow rate and the set pressure limit (Pinsp). This breath is stopped when the key is released or when a fixed time limit of 5 s is reached. The next manual or mandatory breath can only be applied after an expiratory phase (IPPV/IMV) has been completed. If a manual breath is stopped by the time limit, the next mandatory or manual breath can only be applied after a fixed time-out (5 s).

6.2.42-min Silence

Pressing this key will silence the audible alarm for 2 minutes. This status is indicated by the yellow LED on the key. Pressing the key again within the silence time will reactivate the audible alarm.

6.2.5Reset/Check (OK)

Pressing the Reset/Check key (or OK key as of software version 5.n) will confirm or cancel text messages shown on the display. The message currently shown on the display will be cancelled and the audible alarm will be silenced.

Pressing the key for a longer period of time (approx. 2 s) will start a display test and an audible alarm generator test.

6.2.6Backlight On/Off (Babylog 8000/8000 SC with LC Display)

Pressing this key will switch the LCD backlight on or off.

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