Oxylog 2000 Technical Documentation Rev 9.0

Contents General 1

Notes 1.1

3

Symbols and Definitions ... 4

Function Description 1

Intended use of Oxylog 2000

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1.1

7

Intended use of Oxylog 2000 HBO ... 8

2

Patient safety precautions

8

3

MedGV

9

4

Some important technical data

10

5

Comparison Oxylog/Oxylog 2000

11

6

Operating modes

13

6.1

IPPV ... 13

6.2

IPPV, Paw low alarm ... 14

6.3

IPPV, Paw high alarm ... 15

6.4

IPPV, leakage alarm ... 16

6.5

SIPPV (synchronized IPPV) ... 17

6.6

IPPV with PEEP (CPPV) ... 18

6.7

SIMV ... 19

6.8

SIMV trigger window ... 20

6.9

Fixed SIMV frequency ... 21

6.10 CPAP ... 21 7

Functional diagram

23

I

Contents 8

Function description

25

8.1

Gas connection, device switched off ... 25

8.2

Power supply ... 26

8.3

Electronic inputs ... 27

8.4

Electronic outputs ... 28

8.5

Switching the device on, IPPV, inspiratory Air Mix (50%) ... 28

8.6

Bistable valves ... 30

8.7

IPPV, Expiration ... 31

8.8

IPPV, expiration with PEEP >0 mbar (CPPV) ... 32

8.9

IPPV, inspiration, No Air Mix (100%) ... 33

8.10 SIPPV (synchronized IPPV) version ... 34 8.11 Spontaneous breathing (PEEP = 0) ... 34 8.12 CPAP (PEEP >0 mbar) ... 36 8.13 SIMV ... 36 8.14 Pmax ... 37 8.15 Safety valve ... 37 8.16 Auxiliary air valve ... 38 8.17 Flow measurement, autozero ... 38 9

Device holder

41

10

Front panels

42

10.1 Oxylog 2000 front panel (SW 1.XX) ... 42 10.2 Oxylog 2000 front panels (SW 2.XX) ... 43 10.3 Oxylog 2000 front panels (SW 3.XX) ... 44 Pneumatic components layout

45

12

Demand valve

46

II

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12.1 Demand valve functional description ... 46

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11

Contents 13

Pneumatic assembly

47

14

PEEP valve

48

15

Ventilation valve

48

16

Pressure regulator

50

17

Gas inlet

51

18

MV valve

52

19

Oxylog 2000 HBO patient valve

53

20

Control PCB

55

21

Sensor PCB

56

22

Display PCB

57

23

Fuse PCB

58

Maintenance Procedures Replacing consumable items

61

1.1

Replacing/fitting the battery pack ... 61

1.2

Replacing/fitting the AlkMn battery pack ... 63

1.3

Replacing the pressure regulator ... 66

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III

Contents Schematics and Diagrams 1

Printed circuit boards

77

2

Tubing and circuit diagrams

81

Annex Parts catalog Test List Technical Information

K5503160IECIVZ.fm 13.01.06

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IV

General

1

Oxylog 2000 1

Notes

General 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. 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. Use only original Dräger parts and supplies. The maintenance procedures described in this Technical Documentation may be performed by qualified service personnel only. These maintenance procedures do not replace inspections and servicing by the manufacturer. The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of the manufacturer.

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

Reference is hereby made to the observance of the relevant safety provisions, for example in Germany, the Medical Product Law (MPG), the Medical Device Operator Ordinance (MPBetreibV), the Pressure Container Ordinance (Druckbehälterverordnung), the Technical Rules for Pressurized Gases (Technische Regeln Druckgase), or the Occupational Health and Safety Provisions (Unfallverhütungsvorschriften). Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany.

Observe protection mark DIN 34. Copyright reserved.

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Follow the laws and regulations applicable in your country.

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General 1.1

Oxylog 2000

Symbols and Definitions This symbol indicates a warning.

This symbol indicates tips and useful information.

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

= examination of actual condition

Maintenance

= measures to maintain specified condition

Repair

= measures to restore specified condition

Servicing

= inspection, maintenance, and repair

Observe protection mark DIN 34. Copyright reserved.

Inspection

4

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Definitions according to German standard DIN 31051:

Function Description

5

Oxylog 2000 1

Intended use of Oxylog 2000

Function description Oxylog 2000 is a time-cycled, volume-constant emergency lung ventilator for patients with a tidal volume of 100 mL or more. For the ventilation modes: •

Controlled ventilation IPPV with variable TI:TE, adjustable 60 or 100 vol.% O2.

•

Synchronized intermittent mandatory ventilation (SIMV).

•

Spontaneous breathing with continuous positive airway pressure (CPAP).

With monitoring: •

Of the airway pressure (Paw).

•

Of the expiratory minute volume (MV).

With monitoring: •

Of the airway pressure.

•

Of the electrical power supply.

•

Of the gas supply.

•

Mobile use in emergency care or in primary care of emergency care patients.

•

During transport in emergency rescue vehicles or by helicopter.

•

During transfers by road and air.

•

When moving ventilated patients around the hospital.

•

Use in the emergency room.

•

During secondary transfers from hospital to hospital.

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Areas of application:

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Function description 1.1

Intended use of Oxylog 2000 HBO

Oxylog 2000 Oxylog 2000 HBO is a time-cycled, volume-constant emergency lung ventilator for patients with a tidal volume of 100 mL or more. For the ventilation modes: •

Controlled ventilation IPPV with variable TI:TE, adjustable 60 or 100 vol.% O2.

•

Synchronized intermittent mandatory ventilation (SIMV).

•

Spontaneous breathing with continuous positive airway pressure (CPAP).

With monitoring: •

Of the airway pressure (Paw).

•

Of the expiratory minute volume (MV) via the Volumeter 3000 for VT and MV as firm measured variables.

With monitoring: •

Of the airway pressure.

•

Of the electrical power supply.

•

Of the gas supply.

Areas of application: •

Mobile use in emergency care or in primary care of emergency care patients in hyperbaric chambers. The use is restricted to the immediate area inside and outside of the HOB chamber. The Oxylog 2000 HBO is suitable for a pressure of max. 3 bar = 300 kPa absolute (20 m diving depth).

The Oxylog 2000 HBO may only be used with the patient hose system specified in the Instructions for Use manual!

Patient safety precautions

Monitor ventilation During ventilation ensure the patient is continuously monitored by qualified medical personnel.

If the life-supporting function of the lung ventilator can no longer be guaranteed on account of a fault, such as a power failure, ventilation of the patient must be continued without delay using another ventilation equipment, such as a manual ventilation bag, with PEEP and/or increased inspiratory O concentration if necessary.

8

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Keep manual ventilation device ready

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2

Oxylog 2000 3

MedGV

Function description The equipment is a Group 1 equipment according to the MedGV . According to the MedGV § 11 safety checks must be carried out at 2-year intervals. The device must be subjected to inspections and servicing by trained specialists (and the results logged) every 2 years. Standards Table 1 Type of protection

IP X4 (splash-proof)

Protection class of the power supply unit

II (as per EN 60601-1)

Manufacturer's certification on radio interference suppression

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This is to certify that the Oxylog 2000 meets the radio-interference suppression specifications as per EN 55014: 1987/A2 1990 and the immunity specifications as per 89/336/EEC regulation.

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Function description 4

Some important technical data

Oxylog 2000 Table 2 Control principle

Volume metering, time-cycled, volumeconstant Flow chopper Spontaneous breathing with integrated demand valve (also on PEEP level)

Ventilation modes

IPPV, SIMV/CPAP

Ventilatory frequency (f)

5 to 40 1/min ± 1/min

Ventilation time ratio (TI:TE)

1:3 to 2:1 ±5 %

Tidal volume (VT)

0.1 to 1.5 L ±10 %

Minute volume (MV) (at TI:TE = 1:1.5)

min. 1.0 to max. 25.0 L/min

Inspiratory pressure limit (Pmax)

20 to 60 mbar ±10 %

PEEP

0 to 15 mbar

Operating pressure of Demanad valve

approx. –1 mbar

Flow rate at –4 mbar

approx. 120 L/min

Pressure gauge measuring range

–10 to 80 mbar ±2 mbar

Flow measuring range

2 to 120 L/min

MV measuring range

2 to 40 L/min

O2 concentration AIR MIX NO AIR MIX

>7 L/min approx. 60 vol.% <7 L/min up to approx. 80 vol.% 100 vol.%

10

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For further data, refer to the Instructions for Use manual. Only the data specified in the applicable Instructions for Use manual is binding.

Oxylog 2000 5

Comparison Oxylog/Oxylog 2000

Function description Table 3 Features

Oxylog

Oxylog 2000

Working Principle

Flow chopper pneumatically controlled

Flow chopper electronically controlled

Power supply

--

internal: 6 NiCd cells (7.2 VDC) max. operating duration: 10 h 800–1000 charging cycles

Equipment volume

3.2 L

4.8 L

Equipment weight

2.0 kg

<4.0 kg

Ventilation mode

IPPV (with PEEP), EPAP (with optional demand valve)

IPPV (with PEEP) SIMV/CPAP (with integrated demand valve)

PEEP setting

external PEEP valve

integrated PEEP setting

Ventilation volume

Minute volume

Tidal volume

I:E ratio

fixed

variable

O2 concentration

selectable 50 % / 100 %

selectable 50 % / 100 %

inspiratory pressure limit

fixed

variable

Respiratory pressure measurement

only inspiratory

inspiratory and expiratory

Volume measurement

--

expiratory via patient-side flow sensor

Alarms

--

Apnea Leakage Supply pressure Supply voltage

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external: 10–26 VDC

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Function description Oxylog 2000

Oxylog 2000 6

Operating modes

6.1

IPPV

Function description

(Intermittent Positive Pressure Ventilation)

IPPV curve

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Figure 1

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6.2

Figure 2

14

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Function description Oxylog 2000

IPPV, Paw low alarm

IPPV, Paw low alarm

Oxylog 2000 6.3

Function description

IPPV, Paw high alarm

Figure 3

IPPV, Paw high alarm

If the Paw high alarm occurs, the set tidal volume VT is not delivered completely.

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As of SW 3.XX it is possible to adjust the Pmax control knob to 80 mbar. This setting limits the airway pressure to max. 80 mbar without aborting the inspiration prematurely (pressure-limited ventilation). Pressure limit is signaled by one single audible alarm. The set tidal volume is not delivered completely.

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Function description Leakage alarm

Figure 4

IPPV, leakage alarm

In this case, a VTE:VTI comparison is carried out, irrespective of the set MV and frequency.

16

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IPPV, leakage alarm

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6.4

Oxylog 2000

Oxylog 2000 6.5

SIPPV (synchronized IPPV)

Function description SIPPV mode is available as of SW 3.XX.

Figure 5

SIPPV

If the patient triggers within the expected trigger window, the frequency per minute is increased.

If the measured frequency exceeds the set frequency by more than 50%, the following alarm message is displayed: Frequency high. The max. inspiratory time is always limited to 1.3 seconds.

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To access the SIPPV mode, first set the mode selector switch to SIPPV. Then use the info key on the display to go to SIPPV and select with the reset key.

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