Service Manual

Leoni 2

Ventilator for neonates and paediatrics

For trained technicians

only

2006-11-16
Contents

1. About this service manual ........... 1 Visual inspection .........................................28

Visual inspection of the device ..................... 28
Main topics of the service manual ...................1
Visual inspection of the internal
Structure and purpose of the service
hardware....................................................... 30
manual.............................................................1
Information and warnings ................................1
7. Replacing components .............. 31
Storage of documentation ...............................2
Replacing compressed air and oxygen
Additional information......................................2 filters ............................................................. 31
Replacing the oxygen sensor ....................... 33
2. General safety instructions ......... 3
Replacing the flow sensor............................. 34
Replacing the main board............................. 35
3. Overview of the device ................ 5
Replacing the blender................................... 38
Overview of main board ..................................5
Replacing the internal tubing ........................ 44
Overview of battery module.............................6
Replacing the oxygen-bypass module.......... 48
Control panel ...................................................7
Replacing the input pressure regulators....... 49
Front of device.................................................8
Replacing the lithium battery ........................ 51
Rear of device .................................................9
Replacing the exhalation valve
Accessories ...................................................10 membrane..................................................... 52

4. Service and maintenance 8. Maintenance / repair .................. 53

intervals ..................................... 11
Replacing the controller ................................ 53
Replacing the display unit............................. 56
5. Opening the device .................... 13
Replacing the sensor board.......................... 59
Safety instructions .........................................13
Replacing the PC/104 module ...................... 61
Removing the housing...................................14
Replacing the battery controller board.......... 63

6. Standard services ...................... 16 Replacing the battery pack ........................... 65

Preparation & cleaning ............................... 16

Replacing the power supply.......................... 67

General instructions ......................................16 Replacing fuses ............................................ 69

Cleaning device.............................................18
9. Software update ........................ 71
The component groups (type A, B and
C)...................................................................19 Replacing the processors...........................71

Sterilising Type A components......................20 Replacing the controller software (PIC

processors) ................................................... 71
Preparation of Type B components (flow
sensor) ..........................................................23 Replacing the system software
(EPROMs) .................................................... 74
Cleaning TYPE C components (Dual
Airway temperature probe)............................25 Commissioning updated software .............77

Approved cleaning agents.............................27 Commissioning the updated system

software ........................................................ 77
Contents

Calibrating the exhalation valve.................... 80 Setting alarms............................................ 109

Setting patient alarms automatically ...........109
10. Complete device test................. 82 Setting patient alarms automatically ...........110
General......................................................... 82 Setting alarm volume ..................................110
Purpose ........................................................ 82 Acknowledging alarms ............................. 111
Procedure ..................................................... 83 Acknowledging patient alarms ....................111
Required test equipment............................... 83 Acknowledging sensor alarms ....................112
Required documents..................................... 83 Acknowledging system alarms....................113
Symbols ........................................................ 84 Alarm messages & troubleshooting ....... 114
Procedure .................................................... 85 Displaying alarm messages ........................114
Testing the LED display and the Alarm priorities ............................................115
acoustic alarm............................................... 85
Error messages – patient alarms ................115
Adjusting the Air / O2 pressure reducer ........ 87
Error messages – system alarms................117
Calibration of expiration valve....................... 90
Error messages – disconnection alarms.....118
Testing the pressure measurement .............. 92
Error messages – tube obstruction
Testing the volume measurement................. 94 alarms .........................................................118
Testing the oxygen measurement................. 95 Error messages – sensor alarms ................118
Testing the O2 flush function......................... 97
Testing the alarm functions........................... 98 13. Technical data ......................... 120
Testing the electrical safety in Adjustment ranges of ventilation
accordance with IEC 60601-1 or VDE parameters..................................................120
0751.............................................................. 98 Resistance values.......................................121
Accuracy of value display (ATPD)...............121
11. Calibration ................................. 99
Dimensions and weight...............................122
General......................................................... 99
Connections ................................................122
Procedure ..................................................... 99
Environmental conditions............................123
Required test equipment............................... 99
Device service life .......................................123
Required documents..................................... 99
Calibration ................................................. 100
14. Pneumatic diagram.................. 124
Calibration with ETU ................................... 100
Calibration without ETU .............................. 103 15. Main board circuit diagram ..... 125
Calibration of the proximal pressure
sensor on the blender control board ........... 105
16. Accessories & spare parts ...... 126
List of accessories and spare parts.............126
12. Alarms & troubleshooting........ 107
Overview of tubing systems ........................130
Setting range & calculation method ............ 107
Contents
Chapter
About this service manual
1

1. About this service manual

Main topics of the service manual

This service manual describes repair and maintenance

operations.

It includes:

information on safety precautions required for repair

and maintenance work

an overview of device components

instructions for repair and maintenance

Structure and purpose of the service manual

The service manual is structured to assist you with repair

and maintenance work

It is intended for trained technicians only.

Read the service manual carefully before starting repair

and maintenance work.

Information and warnings

Information
Information is provided to supplement the instructions for
actions.

The information suggests actions that can make it easier

and more efficient to operate the ventilator.

1
Chapter
About this service manual
1

Information on dangers
Information on dangers must be read at all times to pre-
vent injuries to persons or damage to the ventilator.

DANGER indicates a latent hazard that is not an immediate threat but if

precautions are not taken it may cause death or personal injury.

DANGER

CAUTION refers to a hazard that may cause damage to the device if

precautions are not taken.

CAUTION

Storage of documentation

Keep the documentation available for reference in an ac-

cessible place near the device.

Additional information

If you have any questions or information on this service

manual or our ventilator, please contact an authorised
dealer or the manufacturer directly.

2
Chapter
General safety instructions
2

2. General safety instructions

The liability for proper function of the device is irrevocably

transferred to the owner or operator of the device if it is
serviced or repaired by persons who are not employed by
Heinen + Löwenstein GmbH Service department or are
not authorised by Heinen + Löwenstein or if it is operated
in a manner contrary to its intended use.

Heinen + Löwenstein GmbH cannot be held responsible

for damage caused by non-compliance with the above
stipulations. The warranty and liability provisions of the
terms of sale and delivery of Heinen + Löwenstein GmbH
are also not modified by the following recommendations.

Approved service technicians Service and safety inspections must be conducted only
by technicians that we have trained and who have the
recommended instrumentation and test equipment.

Combination with other devices Combination with other devices that are not mentioned
in the user manual is permitted only in consultation with
the manufacturer.

Disconnect power Always disconnect the mains power before opening the
housing.

Prevent electrostatic discharge Electrostatic discharge must be prevented during all

work on the device to prevent damage to the compo-
nents and the device.

Take the following precautions before touching a prin-

ted-circuit board or a component attached to a pcb. If
this precaution is not observed the device may be dam-
aged.

All work on the device must be done on a suitable
earthed and conductive work surface (antistatic,
ESD protection).

Make sure that you are sufficiently earthed (e.g. 1
MΩ).

Earth every instrument used during work on the
ventilator.

3
Chapter
General safety instructions
2

Transport components and printed-circuit boards

in the correct antistatic packages only.

Device check before operation Device malfunctions may cause death or permanent
injury to the patient.

Always check the ventilator before operation.

Check sensors regularly Sensor malfunctions may cause death or permanent

injury to the patient.

Calibrate the flow sensor regularly:
- after switching on
- after every sensor change.

Calibrate the O2 sensors regularly:
- every time the device is switched on
- after 24 hours of operation
- after every sensor change.

Sterility The device must be sterilised after all service work.

4
Chapter
Overview of the device
3

3. Overview of the device

Overview of main board

The main board has the following components:

4
1. Sensor board
3 2. PC/104 module
3. Power module
4. Connection cable for control panel

1 2

2 The PIC processors are below the sensor board:

1
5. Controller processor
6. Monitoring processor

5
Chapter
Overview of the device
3

Overview of battery module

The battery module has the following components:

3
1. Battery pack
2. Power supply
1
3. Battery controller board
4. Fuses

4 2

6
Chapter
Overview of the device
3

Control panel

(1) Display (10) Standby

(2) Mode / Home Enables and disables standby mode.
Switch in the settings display for selecting the ventilation Ventilation is stopped in standby.
mode and ventilation parameters. (11) Manual button
(3) Waves Starts a manual breath.
Switches to the waves display. (12) Rotary pulse encoder
(4) Limits The rotary pulse encoder combines a pushbutton and a
Switches to the alarm limits in the settings menu. dial knob.
(5) Power failure LED (13) Softkeys
Shows red if the power fails. The legend to the softkeys is shown at the bottom of the
display.
(6) Battery LED
On during battery operation. (14) ON/OFF
Switches the device on and off.
(7) Warning LED
On/flashes red to indicate a warning message. (15) Calibration/settings
Switches to the calibration screen or the basic settings
(8) Alarm LED screen.
Lights when an alarm is triggered.
Off if no alarm is pending and requires acknowledgment. (16) Contrast
Sets the display contrast.
(9) Alarm mute
Acknowledges or mutes alarms.
On when alarms are muted.

7
Chapter
Overview of the device
3

Front of device

(1) Control panel

(2) Rotary pulse encoder
(3) Inspiration connection
(4) Pressure tube connection
(5) Expiratory connection

8
Chapter
Overview of the device
3

Rear of device

(1) Earth connection

(2) Serial port (RS232)
(3) Flow sensor connection
(4) Oxygen connection (O2)
(5) Access to O2 sensor
(6) Compressed air connection (air)
(7) Mains power connection (100-240V, AC)

9
Chapter
Overview of the device
3

Accessories
(1) Pressure measurement tubing
(2) Expiratory tubing
(3) Inspiratory tubing
(4) Y-piece
(5) Flow sensor
(6) Test lung
(7) Flow sensor cable

10
Chapter
Service and maintenance intervals
4

4. Service and maintenance intervals

Incorrect maintenance
Danger of malfunction and damage to the device!

Only technicians trained by the manufacturer are authorised to carry out
CAUTION the service and safety checks.

Suitable instruments and test equipment are required.

Clean and disinfect the device or device components

before every maintenance procedure – including
when returning the device for repair.

Every 12 months

Service and safety inspection in accordance with

§6 MPBetreibV

The following work is required:

Standard services

Check alarm and limit value functions

Check pressure connections

Check electrical connections

Check safety shutoffs

Calibration

Complete device test with protocol

The following components must be replaced:

oxygen sensor

11
Chapter
Service and maintenance intervals
4

Every 3 years

The following work is required:

Standard services

Calibration

Complete device test with protocol

The following components must be replaced:

Oxygen sensor

Lithium battery

Battery pack

Blender modul (if operating hours > 10000)

Every 10 years

The following work is required:

Standard services

Calibration

Complete device test with protocol

Replacement of oxygen sensor

Replace all internal tube set

The following components must be replaced:

Oxygen sensor

Complete internal tube set

After repairs or updates

Standard services

Calibration

Complete device test with protocol

12
Chapter
Opening the device
5

5. Opening the device

Safety instructions

Opening the device without disconnecting the mains power

Danger of electric shock

Always disconnect the mains power before opening the housing.
DANGER

Electrostatic discharges in the device

Danger of damage to the device

All work on the device must be done on a suitable earthed and con-
CAUTION ductive work surface (antistatic, ESD protection).

Make sure that you are sufficiently earthed (e.g. 1 MÙ).

Earth every instrument used during work on the ventilator.

Transport components and printed-circuit boards in the correct anti-
static packages only.

13
Chapter
Opening the device
5

Removing the housing

Required tools

1 x Philips screwdriver (large)

1 x Allen key, size 4

1. Unscrew the two screws (1) with the Philips

screwdriver (large).
1

2. Pull the top housing off the device towards the

back.

14
Chapter
Opening the device
5

3. Unscrew the two front screws (1) of the battery

holder on both side with the Allen key.

4. Now lift the plate with the battery module (1).

15
Chapter
Standard services
6

6. Standard services

Preparation & cleaning

General instructions

Poor hygiene
Danger of infections

Prepare the device and the tubing system after every use with a patient.
WARNING

Never use disposable products more than once.

Incorrect cleaning and sterilisation

Danger of damage to the device

Never sterilise the ventilator.
CAUTION

Only disinfect the device by wiping it with the approved cleaning agents.

All medical devices contaminated with pathogens

may be the source of human infections.
Re-use and handling of such medical devices requires
comprehensive prior preparation. The measures de-
scribed below are suitable for keeping the device hygienic
and minimising the risk of infection as much as possible.

The procedures described below must be followed by

appropriately trained and qualified persons to keep
the device hygienic.
Read the following section completely before carry-
ing out any of the steps described.

16
Chapter
Standard services
6

Proceed with the following steps to prepare the device

and its components:

Disassemble (for components only)

Pre-treatment

Pre-cleaning

Cleaning

Rinse, dry

Disinfection/sterilisation

Check that all surfaces are clean and undamaged

Function test

Transport and storage

Commissioning
The tasks described here are generally compliant with the
recommendations of the RKI and BfArM “Requirements
for hygiene in the preparation of medical devices” with
reference to the special requirements for ventilators, the
recommendations of the SPECTARIS med association
and, in particular, the materials used in this device.

17
Chapter
Standard services
6

Cleaning device

Working with electricity

Danger of electric shock

Before cleaning and disinfecting the device switch it off and remove the
WARNING plug from the mains socket.

Water inside housing

Danger of damage to the device

Do not allow water to enter the interior of the device.
CAUTION

The outer housing of the device can be washed with

standard cleaning agents. Do not use acidic, abrasive or
corrosive agents.

The removable components of the Leoni2 must be pre-

pared with methods suitable for the material and contact
with the patient.

There are three groups of components (type A, type B

and type C) that must be taken into account when prepar-
ing the device:

18
Chapter
Standard services
6

The component groups (type A, B and C)

1. TYPE A:
The Type A sterilisable components installed near the pa-
tient with indirect contact to mucous membranes are the
following:

expiratory valve (VA, silicone)

ventilation tubing

water trap

y-piece

2. TYPE B:
The Type B sterilisable components installed near the pa-
tient and that can also be pretreated with protein-removal
agents are the following:

flow sensor (polysulfone)

3. TYPE C:
The type C components installed near the patient and with
sensitive surfaces are the following:

Dual Airway temperature probe

19
Chapter
Standard services
6

Sterilising Type A components

1. Disassembly
Carefully remove the Type A components from the
vicinity of the patient.

2. Pre-treatment
Remove surface contamination with a disposable
cloth. Then rinse the components with water.

To prevent deposits we recommend treating Type A

components immediately after use.

3. Pre-cleaning
Additional pre-cleaning of components is not re-
quired.
Very contaminated parts can be pre-cleaned in an
ultrasonic bath (max. 3-5 min).
Special feature of ventilation tubes:
Do not clean the tubing system with detergent (solu-
tions with surface-acting, non-foaming additives).
Rinse the tubing clean and allow to drip dry.

4. Cleaning
Automatic cleaning:

Machine cleaning is preferable to manual prepara-

tion because of work safety and reproducibility of
work processes.

Place Type A components in the automatic
cleaner and disinfectors so the cleaning agent
can flow out of the inside lumen.

Set cycle. It must reach a cleaning temperature
of 93 °C and a cleaning duration of at least 10
minutes.
Follow the cleaning agent manufacturer’s direc-
tions for cleaning time.

When removing the components inspect them
for visible dirt.

The appropriate automatic program should be se-

lected in accordance with the A0 concept (prEN
15883-1, Annex section 4).

20
Chapter
Standard services
6

b. Manual cleaning:
Note:

Use a suitable brush to clean holes and hollow

spaces to reach every part of the component.

Rinse surface contamination thoroughly from
the components.

Clean the exhalatory valve with a soft brush
and surface-active, non-foaming detergents.

Make sure that all interior spaces are also cleaned.

After cleaning rinse the valve under running wa-
ter for two minutes. The interior lumen and
holes must be thoroughly rinsed (several times).

Ensure that all detergent residues have been re-

moved.

5. Disinfection (otherwise sterilisation continue

with section 6)

Immerse the component in a disinfectant solu-
tion after cleaning.

SECUSEPT and SECUSEPT FORTE S from

ECOLAB are suitable disinfectants.

Make sure that there are no air bubbles in the inte-

rior lumen. The Type A components must be rinsed
or completely filled with disinfectant.

Make sure that the components are immersed in

the disinfectant for the time specified by the disin-
fectant manufacturer.

The minimum immersion time is 10 minutes.

Use deionised water for the final rinse.

21
Chapter
Standard services
6

6. Drying

It is very important that the components are dried

thoroughly to prevent water from remaining in tub-
ing and control tubes.

Do not exceed a temperature of 90 °C during dry-

ing.

7. Packaging

Pack Type A components individually in paper,
foil or similar packaging as specified by DIN EN
868. Use the appropriate size of packaging ma-
terial for the size of the component.

Regardless of sterilisation method the packag-
ing is generally:
- mechanically protective packaging
- sterile packaging
- outer packaging if required

Observe the storage periods for sterile goods as per

DIN 58953 Part 8.

8. Sterilisation

Steam-sterilise the Type A components in an
autoclave at
134°C, 3 bar, 5 min.

9. Inspection of all surfaces for dirt and damage

Carefully inspect all surfaces after cleaning and
disinfection.

Inspect the Type A components for obvious
damage.

Sort out damaged Type A components.

10. Function test

Conduct a device check

11. Transport and storage

Store the Type A components in dry, dark
rooms.

12. Commissioning

22
Chapter
Standard services
6

Preparation of Type B components (flow sensor)

Incorrect cleaning of flow sensor

Destruction of sensor wires

Never clean the sensor with compressed air or strong water spray.
CAUTION

Never place the sensor in a cleaning or disinfection machine.

1. Disassembly
Carefully remove the TYPE B components from the
vicinity of the patient.

2. Pre-treatment

Carefully remove obvious residues on the sen-
sor surface with a soft damp cloth or a dispos-
able cloth.

3. Pre-cleaning

Do not immerse the connection cord in water.

Rinse TYPE B components immediately after
use.

Make sure that all electrical wiring has been re-

moved first. Otherwise deposits will form and the
function of the sensor can no longer be guaranteed.

4. Cleaning

Treat TYPE B components with protein-removal
agents because of their closeness to the patient
(solutions containing glutaraldehyde, such as
Glutarex from Henkel).

Additional pre-cleaning of TYPE B components
(flow sensor) is not required.

5. Rinsing, drying

After cleaning wipe the TYPE B components
with a dry cloth. The components must be com-
pletely dried to ensure that they are effectively
disinfected.

23
Chapter
Standard services
6

6. Disinfection (otherwise sterilisation continue

with section 7)

Immerse the component in a disinfectant solu-
tion after cleaning.
SECUSEPT and SECUSEPT FORTE S from
ECOLAB are suitable disinfectants.
(If other disinfectants are used check that they are
compatible with polysulfone and make sure that
they have an antiviral, bactericidal and fungicidal ef-
fect.)

7. Packaging

Pack TYPE C components individually in paper,
foil or similar packaging as specified by DIN EN
868. Use the appropriate size of packaging ma-
terial for the size of the component.

Regardless of sterilisation method the packag-
ing is generally:
- mechanically protective packaging
- sterile packaging
- outer packaging if required

Observe the storage periods for sterile goods as per

DIN 58953 Part 8.

8. Sterilisation

Steam-sterilise the TYPE A components in an
autoclave at
134°C, 3 bar, 5 min.

9. Inspection of all surfaces for dirt and damage

Carefully inspect all surfaces after cleaning and
disinfection.

Inspect the TYPE B components for obvious
damage.

Sort out damaged TYPE B components.

10. Function test

Conduct a device check

11. Transport and storage

Store the TYPE C components in dry, dark
rooms.

12. Commissioning

24
Chapter
Standard services
6

Cleaning TYPE C components (Dual Airway tempera-

ture probe)

1. Disassembly
Carefully remove the TYPE C components from the
vicinity of the patient.

2. Pre-treatment

Remove surface contamination with a dispos-
able cloth.

To prevent deposits we recommend treating

TYPE C components immediately after use.

3. Precleaning

Additional precleaning of components is not re-
quired.

4. Cleaning

5. Disinfection

Wipe the TYPE C components thoroughly with
a disposable alcohol wipe or disinfect them with
a spray disinfectant.

6. Drying

The component must be dry before using it
again.

7. Sterilisation

TYPE C components are NOT sterilised.

8. Packaging

Pack TYPE C components individually in paper,
foil or similar packaging as specified by DIN EN
868. Use the appropriate size of packaging ma-
terial for the size of the component.

Regardless of sterilisation method the packag-
ing is generally:
- mechanically protective packaging
- sterile packaging
- outer packaging if required

25
Chapter
Standard services
6

9. Inspection of all surfaces for dirt and damage

Carefully inspect all surfaces after cleaning and
disinfection.

Inspect the TYPE C components for obvious
damage.

Sort out damaged TYPE C components.

10. Function test

Conduct a device check

11. Transport and storage

Store the TYPE C components in dry, dark
rooms.

12. Commissioning

26
Chapter
Standard services
6

Approved cleaning agents

We recommend using only the following cleaning
agents and disinfectants.

Surface disinfection:

Incidin Extra N (Henkel ECOLAB)
Observe the manufacturer’s directions for use

If a different agent is used note the DGHM recommenda-

tions and the compatibility of the agent with plastics.

Disinfection of TYPE A:

SECUSEPT or SECUSEPT FORTE S from
ECOLAB
Observe the manufacturer’s directions for use

If a different agent is used note the DGHM recommenda-

tions and the compatibility of the agent with plastics.

Disinfection of TYPE B:

SECUSEPT or SECUSEPT FORTE S from

ECOLAB

Glutarex from Henkel
Observe the manufacturer’s directions for use

If a different agent is used note the DGHM recommenda-

tions and the compatibility of the agent with plastics.

27
Chapter
Standard services
6

Visual inspection

Visual inspection of the device

Working with damaged ventilator.

Danger of personal injury and damage to the device

Dispose of the ventilator if visible damage to cables, connectors, hous-
WARNING ing or other components is found.

Visual inspection

1. Check that the nameplate is correctly attached

to the rear of the device and shows the serial
number and date of manufacture.

2. Check that the serial number on the device is

the same as the serial number on the documen-
tation (Device Configuration, PA-10-65, PA-10-
68).

3. Check that the device is clean and has no scrat-

ches.

4. Check that all externally accessible screws, nuts

and connections are correctly fastened.

5. Check that the labels on the rear panel are pre-

sent and clearly legible.

28
Chapter
Standard services
6

Visual inspection of housing

Check the device for the following damage:

- Damage caused by dropping it

- Scratches, cracks, flaws around the display
- Damage to the keyboard
- Damage to the inspiratory and expiratory
ducts and tubes
- Excessive dirt
- Any corrosion

29
Chapter
Standard services
6

Visual inspection of the internal hardware

1. Check for visible damage to modules or housing

components inside the device.

2. Check that all required connectors are in posi-

tion.

3. Check whether any pins on the connected mod-

ules are bent or whether modules are incorrectly
installed.

4. Check that all accessible screws, nuts and con-

nections are correctly fastened.

5. Check that all wiring, ribbon cables and other

connections are undamaged.

30
Chapter
Replacing components
7

7. Replacing components

Replacing compressed air and oxygen filters

Required tools

1 x Allen key, size 4

1. Unscrew the Allen screw inside the compressed-

air and oxygen connection (Allen key, size 4).

After removal of the retaining screw the filter (1)

can be removed.
1 2. Hold the ventilator so the filter can fall out.

3. Install the new filter (1).

1 2 4. Install the retaining screw (2) with unthreaded

area to the inside.

31
Chapter
Replacing components
7

Do not apply a load to the filter at the screw.

5. Tighten the retaining screw with the Allen key.

32
Chapter
Replacing components
7

Replacing the oxygen sensor

Malfunction of sensors
Uncalibrated O2 sensors may result in the patient receiving too much
or too little oxygen.
WARNING
Always calibrate sensor before connecting it to the patient, and make
sure that the calibration is correctly completed.

1. Unscrew the screws around the O2 sensor flap.

2. Disconnect the cord from the O2 sensor.
3. Unscrew the O2 sensor.
4. Replace it with a new sensor.
5. Connect the O2 sensor with the connector.
6. Close the O2 sensor flap and tighten the screws.

33
Chapter
Replacing components
7

Replacing the flow sensor

Uncalibrated sensor
Uncalibrated flow sensors may result in the patient receiving too much
or too little oxygen.
WARNING
Calibrate the sensor after replacement

Replacing flow sensor with PSV, SIMV or SIPPV

Changing ventilation mode
If the flow sensor is replaced during operation in PSV, SIMV or SIPPV venti-
lation mode, the device automatically switches to controlled ventilation
mode.

1. Press the calibration/settings button to switch

to the CHECK SENSORS monitor.

2. Press FLOW SENSOR DEACTIVATE.

3. Replace the flow sensor as quickly as possible.

If a replacement sensor is not available:

Connect the tube-side tube system directly to the
y-piece.

4. After replacement:
Press FLOW SENSOR ACTIVATE.
5. Calibrate the sensor.

34
Chapter
Replacing components
7

Replacing the main board

Required tools

1 x Philips screwdriver (small)

1 x Allen key, size 4

1 x Allen key, size 5.5

1. Open the housing.

Opening the device

2. Disconnect the following connectors on the main

1 board:

3 - Keyboard flat-pin plug (1)

Display ribbon cable (2)
5 -
4 - Display power supply (3)
- Blender/DIF ribbon cable (4)
2 - Power supply ribbon cable, blue (5)
- Interface module ribbon cable (6)
6

35
Chapter
Replacing components
7

3. Now remove the following modules:

- Sensor module (1) (see “Replacing the

sensor module“)
- PC/104 module (2) (see “Replacing the
PC/104 module“)

2
1

4. Disconnect the alarm sensor connector (1).

5. Disconnect the proximal pressure tube (1) from

the pressure sensor.

36
Chapter
Replacing components
7

6. Unscrew all screws and spacers on the main

board.

7. Remove the main board.

37
Chapter
Replacing components
7

Replacing the blender

Required tools

1 x Allen key, size 4

1 x Allen key, size 5.5

1 x Philips screwdriver (small)

8. Open the housing.

Opening the device
1. Disconnect the proximal pressure measurement
tube (1).
1

2. Unscrew the two screws on the rear panel and

1 the two screws on the housing bars on both si-
des (1).
3. Remove the bottom of the housing.

38
Chapter
Replacing components
7

1. Now remove the front panel (1) and the terminal

panel (2).
1 Maintenance / repair

2. Turn the device around.

3. Unscrew four (1) of the six screws that hold the
bottom plate.
1

4. Raise the bottom plate.

39
Chapter
Replacing components
7

5. Disconnect the two ribbon cables (1) from the

blender control board.

1 2 6. Pull the proximal pressure tube (2) off the pres-

sure sensor.

7. Unscrew the two screws (1) on both sides of the

distributor module.

8. Remove the module.

Tubes must be disconnected before the module

can be placed aside.
9. Disconnect the three tubes (1).

40
Chapter
Replacing components
7

10. Unscrew the four hex screws (1) with the socket
(size 5.5).
1

11. Disconnect the pressure tube (1) from the blen-

der control board.

12. Disconnect the two pressure measurement tu-

bes from the pressure regulators (1).

Pull the tubes while simultaneously pressing the

tube clips opposite to the direction of pulling the
tubes out.

41
Chapter
Replacing components
7

13. Now remove the blender control panel.

14. Unscrew the four screws (1) that hold the blen-
der unit (2) with a Philips screwdriver.

1
2

15. Disconnect the two blender pressure tubes from

the pressure regulators (1).

Pull the tubes while simultaneously pressing the

tube clips opposite to the direction of pulling the
1 tubes out.

42
Chapter
Replacing components
7

16. Disconnect the two tubes (2) of the oxygen by-

pass module (1).

17. Now remove and replace the blender unit (1).

43
Chapter
Replacing components
7

Replacing the internal tubing

Required tools

1 x Allen key, size 4

1 x Allen key, size 5.5

1 x Philips screwdriver (small)

A tube set consists of the following components:

1 x high-pressure tube blue, 10 bar

1 x high-pressure tube yellow, 10 bar

1 x pressure-measurement tube, blue, transpar-
ent

1 x pressure-measurement tube, yellow, trans-
parent

1 x equalisation lung with 2 T-pieces

1 x filter with two tubes
(1 x short, 1 x long)

3 x silicone tube, transparent
Because the blender unit is normally replaced
when the tubing is replaced, the internal and ex-
ternal tubes are not listed here.

Reverse the two high-pressure tubes (1 and 2).

Note the direction of the arrow (flow direc-
tion) on the pressure regulators.
1. Lead the yellow tube (1) from the compressed-
air connection to the inlet of the adjacent pres-
sure regulator.
2. Lead the blue tube (2) from the oxygen connec-
1 2 tion to the inlet of the adjacent pressure regula-
tor.

44
Chapter
Replacing components
7

3. Attach the equalisation lung (2) with the two T-

pieces to the short tube of the filter element (2).
4. Connect one of the three silicone tubes to the
second T-piece (3).
3 This silicone tube is later fed to the oxygen-
1 bypass module.
2

5. Connect the first T-piece (1) to the centre trans-

parent-white tube of the blender block.
6. Install the blender block in the housing.

7. Connect the two blender pressure tubes to the

pressure regulators (1).
8. Run the two tubes from the rear to the pressure
regulator.
3
2 9. Connect the yellow tube to the left pressure
1 regulator (2).
10. Connect the yellow tube to the left pressure
4 regulator (3).
11. Position the equalisation lung in the right side of
the housing (4).

45
Chapter
Replacing components
7

12. Connect the silicone tube from the T-piece to the

top tube connection of the oxygen-bypass mod-
ule.
13. Press the transparent tube from the blender into
1 the bottom tube connection.

14. Connect the blue pressure-measurement tube to

the top pressure sensor (1) on the blender con-
trol board.
15. Connect the yellow pressure-measurement tube
1 to the bottom pressure sensor (2) on the blender
control board.

16. Mount the blender control board on the blender

block and install the blender unit in the ventila-
tor.
2 Replacing the blender P. 38

Mount the two pressure measurement tubes of the

blender control board to the pressure regulator (1):
17. Run the two tubes from the front to the pressure
regulator.
1 18. Connect the yellow tube to the left pressure
3 regulator (press tube in).
19. Connect the blue tube to the right pressure regu-
2 lator (press tube in).
20. Connect the large ribbon cable from the blender
to the blender control board (2).
21. Now connect the small ribbon cable (3).

46
Chapter
Replacing components
7

22. Turn the device around.

23. Connect a transparent silicone tube for the pro-
1 ximal pressure measurement to the pressure
sensor on the main board (1).
24. Run the tube through the opening in front of the
display to the bottom of the device.

25. Mount the second transparent silicone pressure

tube (1) on the centre pressure sensor on the
blender control board.

26. Pre-assemble the gas distributor module.

2 Replacing the blender P. 38
3 1
27. Mount the pressure tube from the blender con-
trol board to the centre connection nipple (1).
28. Mount the proximal pressure tube from the main
board to the right connection nipple (2).
29. Mount the tube from the filter to the left connec-
tion nipple (3).

The tubing is now fully exchanged.

47
Chapter
Replacing components
7

Replacing the oxygen-bypass module

The device must be opened from the bottom to re-

place the oxygen-bypass module (1).
1. Disconnect the two tubes (2) from the module.
1

2. Unscrew the two screws (1) on the rear panel.

The module can now be removed with the
mounting plate through the rear panel.
1

3. Unscrew the oxygen sensor from the module.

The module can now be replaced.

48
Chapter
Replacing components
7

Replacing the input pressure regulators

To replace the input pressure regulators (1) we

recommend removing the blender with control
board first (open the device from below before-
hand).
The pressure tubes to the blender must also be
1 1 disconnected. Disconnect them by simultane-
ously pressing the tube clips opposite to the di-
rection of pulling the tubes out.

1. Unscrew the two screws (1) to be able to re-

move the input pressure regulator from the in-
side.

2. Remove the high-pressure tube (1 or 2).

1 2

49
Chapter
Replacing components
7

During installation make sure that the pressure

regulator in installed in the correct flow direction.
The printed number (1) marks the inlet and out-
let as follows:
1. Inlet of high-pressure tube
2. Outlet for reduced pressure (T-piece)
3. Replace the pressure regulator and connect it to
the high-pressure tubes again.
1

50
Chapter
Replacing components
7

Replacing the lithium battery

Required tools

1 x soldering iron

1. Remove the main board.

Replacing the main board
The lithium cell is on the left bottom side of the
main board (viewed from the front of the device).

The lithium cell has three pins that are soldered

to the main board.

2. Solder the 3 pins (1) to the back of the main

board.
3. Now solder the new lithium battery in position.

51
Chapter
Replacing components
7

Replacing the exhalation valve membrane

Installation of the exhalation valve membrane backwards

Device malfunction

Make sure that the membrane is correctly aligned:
CAUTION TOP is up.

Always check that the membrane operates correctly immediately after
installation.

The exhalation valve membrane is in the membrane

holder (1).

1 1. Rotate the membrane holder anticlockwise to

remove it.

The exhalation valve membrane (1) is fitted in the

membrane holder.
1
The top of the membrane is marked “TOP”.

Make sure that the membrane is correctly

aligned.
2. Insert the new membrane into the membrane
holder.
3. Replace the exhalation valve in the device and
fasten by turning it slightly clockwise (to the
stop).
4. Check that the membrane operates correctly.

52
Chapter
Maintenance / repair
8

8. Maintenance / repair

Replacing the controller

Required tools

1 x Philips screwdriver (large)

1 x Philips screwdriver (small)

1 x slot screwdriver (small)

The controller (keyboard, alpha dial knob, dis-

play housing) can be replaced as a unit.

1. Disconnect the keyboard connector (1) from the

main board.
It is at the right front of the main board, and
connects it to the keyboard by a ribbon cable.
1

53
Chapter
Maintenance / repair
8

2. Unscrew the two screws (1) on the side of the

front panel.

3. Carefully remove the panel.

The best way is to remove one side of the panel

from the clamp first.

4. Unscrew the two screws (1) at the bottom front

of the housing.

5. Now unscrew the two top screws on the front of

the housing.

54
Chapter
Maintenance / repair
8

Make sure that the ribbon cable is not damaged

when pulling it out through the front plate (1).
6. When the screws are removed the control unit
can be carefully pulled out from the front.

7. Disconnect the ribbon cable connector at the

alpha dial knob (1) and the ribbon connector
sleeve (2) from the earth tab.
1 8. Remove the control unit.

The new control unit can now be installed.

55
Chapter
Maintenance / repair
8

Replacing the display unit

Required tools

1 x Philips screwdriver (large)

1 x Philips screwdriver (small)

1 x slot screwdriver (small)

Preparation: follow the instructions for “Replacing the

control unit” to remove the control unit from the de-
vice to access the display unit.

All the electrical connections between the dis-

1 play unit and the main board must be discon-
nected before the display unit can be removed.
1. Disconnect the display power connector (1).

2. Lift the terminal retainer (1) of the display ribbon

cable on both sides with a flat screwdriver to re-
lease the retainer.

56
Chapter
Maintenance / repair
8

3. Disconnect the cable.

Be careful not to lose the retainer washers.

4. Unscrew the four screws at the corners of the
display with a Philips screwdriver (small).

When removing the display be careful with the

1 cable bushings (1).
5. Remove the display.

57
Chapter
Maintenance / repair
8

Note the following when installing the new dis-

play:
1 1) The ribbon cable must be installed with the
cable contacts upwards (1)
2) The ribbon cable must not be bent too much.

6. Install the new display and pass the cable

through the bushings.
7. Screw the display into place.

8. Press the ribbon cable into the cable terminal

with the contacts up to the stop.
9. Lock the terminal by pressing on the two outside
edges.

10. Plug the two-strand power cable into the socket

1 (1).

58
Chapter
Maintenance / repair
8

Replacing the sensor board

Careless connection and disconnection of sensor board

Damaged pins and device malfunction.

When removing the sensor board always keep it parallel to the main
CAUTION board to prevent the pins from being bent.

When installing the sensor board make sure that it is positioned correctly
to prevent damage to pins or leaving pins disconnected.

Required tools

1 x Philips screwdriver (small)

The sensor board (1) is on the main board above the

PC/104 module (viewed from the front panel).

The sensor board is fixed to the main board by

three Philips screws.

Make sure that the sensor board is always kept

parallel to the main board when removing it.
1. Unscrew the three screws (1) with a Philips
screwdriver (small).
1 2. Lift up the sensor board (vertically from the main
board).

59
Chapter
Maintenance / repair
8

The controller processor (1), the monitoring

1 2 3 processor (2) and the terminal strip (3) are under
the sensor board.

When installing the new sensor board make

sure that it is positioned correctly.

60
Chapter
Maintenance / repair
8

Replacing the PC/104 module

Incorrect positioning and removal of the PC/104 module

Damaged pins and device malfunction

When removing the PC/104 module always keep it parallel to the main
CAUTION board to prevent the pins from being bent.

When installing the PC/104 module make sure that it is positioned cor-
rectly to prevent damage to pins or leaving pins disconnected.

Required tools

1 x Philips screwdriver (small)

The PC/104 module (1) is on the main board to the

left of the sensor board (viewed from the front
panel).

1 1. Unscrew all four retaining screws (1) with a Phil-

ips screwdriver.

Always keep the PC/104 module parallel to the

main board when lifting it out.
2. Pull the pins out of the sockets slowly by lifting
all four corners of the board slightly in turn.

This careful procedure is required because of

the large number of pins.

61
Chapter
Maintenance / repair
8

The PC/104 terminals, among other items, for

the module contact are under the PC/104 mod-
ule.

When installing the new module make sure that

it is positioned correctly.
3. Carefully press the corners of the board care-
fully down in turn to prevent any pins from being
damaged.

It may be necessary to update or replace the

system software.
1 Software update

62
Chapter
Maintenance / repair
8

Replacing the battery controller board

Required tools

1 x Allen key, size 5.5

1 x Philips screwdriver (small)

The battery controller board (1) is to the right of the

battery pack on the battery module.
1

1. Disconnect the plug connector from the battery

pack (1).
2
2. Disconnect the plug connector from the power
supply (2).
3. Disconnect the plug connector from the main
1 board (3).

63
Chapter
Maintenance / repair
8

4. Unscrew the six screws (1) with the Philips

screwdriver.
5. Lift off the battery controller board.
1

64
Chapter
Maintenance / repair
8

Replacing the battery pack

Incorrect installation of the battery pack

Damage to the battery pack

When installing the new battery pack make sure that the pack, its protec-
CAUTION tive casing and internal wiring are not damaged.

Make sure that the battery pack is correctly positioned.

Required tools

1 x Allen key, size 5.5

The battery pack (1) is on the left side of the battery

module and is fixed by a retainer plate.

65
Chapter
Maintenance / repair
8

1. Disconnect the plug connector (1) to the battery

board.

2. Unscrew the six screws (1) with the Philips

screwdriver.
3. Remove the retainer plate.
4. Carefully lift up the battery pack.

Note the following when installing the new bat-

1 tery pack:
1.) the protective casing (and any internal wiring)
must not be damaged
2.) make sure that the battery pack is correctly
positioned

5. Install the new battery pack.

66
Chapter
Maintenance / repair
8

Replacing the power supply

Incorrect replacement of the power supply

Damage to the heat-conductive foil

Heat conductive foil is installed between the right side of the power sup-
CAUTION ply and the retainer plate and it must not be removed or damaged.

Required tools

1 x Allen key, size 5.5

The power supply (1) is at the bottom right on the

battery module.

1. Disconnect the plug connector from the power

connection (1).

67
Chapter
Maintenance / repair
8

2. Disconnect the plug connector (1) to the battery

board.

Do not damage or remove the heat conductive

foil between the right side of the power supply
and the retainer plate.
3. Unscrew the four nuts (1) with the socket (5.5).

1
2

68
Chapter
Maintenance / repair
8

Replacing fuses

Using incorrect fuses

Danger of fire

The fuse must be the same value as that of the voltage on the name-
CAUTION plate.

Required tools

1 x slot screwdriver (small)

The main fuses are at the back of the device in the

mains power input.
1 1. Loosen the tab (1) on the top of the fuse insert
by pressing it down with a screwdriver.

2. Loosen the bottom tab (1) in the same way.

The fuse holder can now be removed.

69
Chapter
Maintenance / repair
8

3. Replace the faulty fuses with fuses of the same

type.

4. Insert he fuse holder with the fuses carefully into

the power socket retainer.
5. Press the fuse holder in until the two fuse tabs
click into place.

70
Chapter
Software update
9

9. Software update

Replacing the processors

Replacing the controller software (PIC processors)

Careless connection and disconnection of sensor board

Damaged pins and device malfunction

When removing the sensor board always keep it parallel to the main
CAUTION board to prevent the pins from being bent.

When installing the sensor board make sure that it is positioned correctly
to prevent damage to pins or leaving pins disconnected.

Electrostatic discharges in the device

Danger of damage to the device

All work on the device must be done on a suitable earthed and conduc-
CAUTION tive work surface (antistatic, ESD protection).

Make sure that you are sufficiently earthed (e.g. 1 MÙ).

Earth every instrument used during work on the ventilator.

Transport components and printed-circuit boards in the correct antistatic
packages only.

Required tools

1 x Philips screwdriver (small)

1 x IC extractor

71
Chapter
Software update
9

Equipment for personal earthing

e.g. wrist band with spiral cable, ESD
sheath ad ESD shoes

The monitoring processor is a processor with 40

pins in the DIP housing.

The controller processor is a processor with 28

pins in the DIP housing.

The controller processor is on the main board under

the sensor board (1).

72
Chapter
Software update
9

1. Unscrew the three screws (1) with a Philips

screwdriver (small)

Make sure that the board is kept parallel to the

main board when lifted.
2. Pull the sensor board up.

Two processors will be visible:

1 2

controller processor (1)

monitoring processor (2)

3. Lift the desired processor up with the IC extrac-

tor.

Make sure it is correctly aligned:

wafer notch up.
4. Install a new processor.

5. Replace the sensor board on the connector and

press it carefully into place.

6. Screw the three screws in again.

73
Chapter
Software update
9

Replacing the system software (EPROMs)

Electrostatic discharges in the device

Danger of damage to the device

All work on the device must be done on a suitable earthed and conduc-
CAUTION tive work surface (antistatic, ESD protection).

Make sure that you are sufficiently earthed (e.g. 1 MΩ).

Earth every instrument used during work on the ventilator.

Transport components and printed-circuit boards in the correct antistatic
packages only.

Required tools

1 x Philips screwdriver (small)

1 x IC extractor

Equipment for personal earthing

e.g. wrist band with spiral cable, ESD sheath ad
ESD shoes

The EPROMs are components with 32 pins in the

FDIP housing.

74
Chapter
Software update
9

The system software is in two EPROMs on the

PC/104 board (1).

Both EPROMs must be replaced at the same

HI LO
time to update the system software.

Note the correct labels (HI and LO) and the cor-
rect alignment of the ICs´.

1. Remove the LO EPROM first with the IC extrac-

tor.

75
Chapter
Software update
9

2. Now remove the HI EPROM with the IC extrac-

tor.

Note correct alignment: wafer notch up.

HI LO
3. Insert the updated HI EPROM into the left IC
socket.
4. Insert the updated HI EPROM into the left IC
socket.

76
Chapter
Software update
9

Commissioning updated software

After replacing the system software the following steps are
required to ensure that the device will continue to operate
correctly:

Commissioning the updated system software

1. Connect the standard tubing system.

2. Connect the bellows test lung to the Y-piece.

3. Switch on the device.

The following steps are required to delete or

overwrite any parts of the previous software and
thus to ensure that the updated software will op-
erate correctly.

4. Switch on the device and wait for the self-test to

end (a STATUS unequal 0000 may be displayed
here).

5. Press the alarm limit button to switch to the

alarm limit monitor.

77
Chapter
Software update
9

6. In the ALARM LIMITS monitor set every alarm

limit to a value other than the current value ma-
nually.
7. Then press AUTOSET ALL.

8. Press the Calibration/Settings button twice to

switch to the SETTINGS menu.
2x
9. Press the Mute Alarm button and Softkey F3
simultaneously to open the SYSTEM
+ DIAGNOSTICS monitor.

10. If no value appears under Ident# (0000), press

the Mute Alarm button and Softkey F2 simulta-
neously until a signal sounds.
This assigns a new identification number to the
device.

11. Now disconnect the pressure tube on the device

and press Softkey F2 to calibrate the proximal
pressure sensor.

Finally all ventilation modes must be selected

again.
12. Press the Mode button to select the respiration
type.

78
Chapter
Software update
9

13. Select the following ventilation modes in succes-

sion
IPPV/IMV
CPAP
TRIGGER
SIMV
SIPPV
PSV

14. Now calibrate the O2 sensor in the

CALIBRATION monitor.

79
Chapter
Software update
9

Calibrating the exhalation valve

The exhalation valve must be calibrated after every

software update. This requires the following steps:

1. Connect the standard tubing system with small

test lung).

2. Set the following values on the device:

I-FLOW 10 l/min

E-FLOW 5 l/min

PEEP 5 cmH2O

P INSP 50 cmH2O

FREQUENCY 30 BPM

I-TIME 1.00 sec

OXYGEN 21 %

3. Calibrate the flow sensor in the CALIBRATION

monitor.

80
Chapter
Software update
9

The calibration process can only be started if no

+ value is highlighted (modifiable) (press the IPPV

softkey first if necessary).

4. Start the AV calibration by pressing the Mute

Alarm button and Softkey F2 simultaneously
and holding until CALIBRATE EXH VALVE ap-
pears.

5. Wait until the following values have been set.

P max = 50 cmH2O

PEEP = 5 cmH2O .
The calibration is now complete.

6. Press the Calibration/Settings key to exit the

calibration process.

81
Chapter
Complete device test
10

10. Complete device test

General
Unauthorised personnel or unsuitable test instruments
Danger of device damage and loss of guarantee

The tests must be conducted by technicians only.
CAUTION They must be authorised by the manufacturer of the ventilator.

Approved and calibrated test instruments only must be used.

Purpose

The device is run through a test procedure to ensure that

it operates correctly and conforms to the device specifica-
tions.

The test checks and documents all parameters that the

manufacturer includes in the device specifications. It also
includes all measurements that guarantee the safety of
the operator, the patient and other persons. The test also
forms the basis of the traceability required by law in the
event the device malfunctions.

The test is base on the following standards:

EN 60601-1

EN 46001

MPG (German medical devices act)

CE mark

82
Chapter
Complete device test
10

Procedure

The procedure for a complete device test is described be-

low, and the results must be recorded in test instruction
PA-10-65.

Required test equipment

Special test procedures and instruments are required to

conduct the testing.

In general, only test instruments that are regularly

checked and calibrated by certified calibration service to
guarantee that they have the required accuracy.

The following equipment is required:

ETU-II electronic tester (if available)

PF300 flow analyser (IMT)

Leoni flow sensor

Leoni test lung (art. no. 0217027)

Small test lung

Protective conductor tester

ELABO 90-2A

Stop watch

Required documents

Test Instruction PA-10-65

83
Chapter
Complete device test
10

Symbols

General note / additional information

Make settings on device

Make entries in protocol

Adjust device structure / measurement structure

Run test

Clean / disinfect

84
Chapter
Complete device test
10

Procedure

Testing the LED display and the acoustic alarm

Connect device to mains power and switch on

Check intensity of LE backlighting

Enter result at 1.1 in Test Instruction PA-10-
65.

Test and enter result at 1.2 in Test Instruction

PA-10-65:

red LED (warning LED) for system errors
flashes

red LED (alarm LED) for alarm switched
on

yellow LED (mute alarm LED) switched

on

green LED (power LED) is switched on

Test and enter result at 1.3 in Test Instruction

PA-10-65:

acoustic alarm sounds

Disconnect mains power cable

85
Chapter
Complete device test
10

Power failure alarm function:

Test and enter result at 1.4 in Test Instruction
PA-10-65:

acoustic alarm sounds

red LED (alarm LED) flashes

yellow LED (battery LED) is switched on

green LED (power LED) is switched off

Power failure alarm OFF function:

press Mute Alarm button:

Test and enter result at 1.5 in Test Instruction

PA-10-65:

acoustic alarm stops

red LED (alarm LED) is off

yellow LED (battery LED) remains on

green LED (power LED) remains off

Check that flow sensor board and processor

board are correctly installed.

Check that ribbon cable from monitor to main

board is correctly connected.

Clean interior of ventilator.

Make sure that the monitor area is com-

pletely free from dust.

Install housing cover immediately afterwards.

86
Chapter
Complete device test
10

Adjusting the Air / O2 pressure reducer

Switch on device

Press and hold Softkey F1 and Mute Alarm

button simultaneously until SYSTEM
ALARMS NOT ACTIVE is displayed at bot-
tom left.

Prepare PF300 flow analyser for flow meas-

urement.
On the PF300 select Menu  Calibration 
Pressure/Flow Offset Calibration and run
offset calibration.
Connect ventilator inspiration tube directly to
the base flow inlet of the PF300.

Connect the supply lines for air (1) and oxy-

gen (O2) (2) to the ventilator.

Make shure that the pressure of the

supply gas is in limit of 5(±
± 0,5) bar .
1 2

87
Chapter
Complete device test
10

In IPPV mode select the following ventilation

settings:
I-FLOW 32 l/min
E-FLOW 2 l/min
PEEP 5 cmH2O
P INSP 30 cmH2O
FREQUENCY 15 BPM
I-TIME 2.00 sec
OXYGEN 21% (Flush 100%)

Adjust the pressure regulator for air (1) on

the ventilator with a screwdriver for the fol-
lowing values for I-Flow and E-Flow on the
PF 300:
I-Flow: 32 (± 1) l/min
1
E-Flow: 2 (±0,3) l/min
(rotate clockwise = increase flow)

Enter in 3.2 of PA-10-65

Switch on O2 flush (100%).

Adjust the pressure regulator for oxygen

(1) on the ventilator with a screwdriver for the
following values for I-Flow and E-Flow on the
PF 300:
I-Flow: 32 (± 1) l/min
1
E-Flow: 2 (±0.3l) l/min
(rotate clockwise = increase flow)

Enter in 3.3 of PA-10-65

88
Chapter
Complete device test
10

Check the settings again:

Make the following settings for pure com-
pressed air and 100% O2 (by FLUSH) and
check the result in the PF 300:
1)
I-FLOW 1 (±0.3) l/min
E-FLOW 2 (±0.3l) l/min
2)
I-FLOW 10 (±0.3l) l/min
E-FLOW 5 (±0.3l) l/min

Reactivate system alarms.

If the specified flow values are not reached,

setting the I-FLOW setting to 32 l/min for a
short time may help, if necessary open fixed
valves.

89
Chapter
Complete device test
10

Calibration of expiration valve

Connect standard tubing system (with small

test lung).

In IPPV mode select the following ventilation

settings:
I-FLOW 10 l/min
E-FLOW 5 l/min
PEEP 5 cmH2O
P INSP 50 cmH2O
FREQUENCY 30 BPM
I-TIME 1.00 sec
OXYGEN 21 %

Make sure that the flow sensor is cali-

brated.
Flow sensor calibrated (in CHECK SENSORS
monitor).

Switch the main screen (VENTILATION

SETTINGS monitor).

90
Chapter
Complete device test
10

Start AV calibration
Press and hold Softkey F2 and Mute Alarm
button simultaneously until CALIBRATE EXH
VALVE is displayed.

The calibration process can only be

started if no value is highlighted (modifi-
able) (press the IPPV softkey first if nec-
essary).

Wait until the following values have been set.

P max 50 cmH2O
PEEP 5 cmH2O
The calibration is now complete.

Press the Calibration/Setting button to finish

the expiration valve calibration.

91
Chapter
Complete device test
10

Testing the pressure measurement

Connect test lung and standard tubing sys-

tem.

Prepare PF300 flow analyser for pressure

measurement.
On the PF300 select Menu  Calibration 
Pressure/Flow Offset Calibration and run
offset calibration.

Connect the pressure measurement tube of

the ventilator to the differential pressure
measurement input of the PF300 with the T-
piece.

92
Chapter
Complete device test
10

Set the following values on the monitor for the

IPPV ventilator setting:
I-FLOW: 10 l/min
E-FLOW: 2 l/min
PEEP: 0 cmH2O
P INSP: 10 cmH2O
FREQUENCY: 30 BPM
I-TIME: 1.00 sec
O2: 21 %

Enter the following in 3.3 in PA-10-65:

Read the values for Pinsp and PEEP on
the PF300(Pdiff) and on the ventilator,
check them and enter in the table.

The pressure values on the PF300 must

be set to cmH20.
Repeat this procedure for all other pressure
settings as per Table 3.3

Attach the test lung (small) for the last

three tests in the table (PEEP values).

93
Chapter
Complete device test
10

Testing the volume measurement

Connect the Leoni test lung.

Make sure that the flow sensor is switched on

and calibrated.

Check off flow sensor calibration in PA-10-65

under 2nd device calibration.

Set all setting positions to the end values or

OFF in the alarm limits monitor.

Set the following values on the monitor for the

IPPV ventilator setting:
I-FLOW: 10 l/min
E-Flow: 2 l/min
PEEP: 0 cmH2O
P INSP: 10 cmH2O
FREQUENCY: 30 BPM
I-TIME: 1.00 sec
O2: 21 %

Enter the following in 3.4 PA-10-65:

Read the values for minute volume
(MV), tidal volume (Vte) on the ventilator
and enter in the table.

Repeat this procedure for all other pres-
sure settings as per the table.

94
Chapter
Complete device test
10

Testing the oxygen measurement

The oxygen on the PF300 can only be meas-

ured at the high flow inlet.
Connect the inspiration connection of the ven-
tilator directly to the high flow inlet of the
PF300.

If a 10 mm to 22 mm adapter is not avail-

able, use a 19 mm to 10 mm silicone
tube.

Press and hold Softkey F1 and Mute Alarm

button simultaneously until SYSTEM
ALARMS NOT ACTIVE is displayed at bot-
tom left.

Now select the following ventilation settings:

I-FLOW 8 l/min
E-FLOW 4 l/min
PEEP 5 cmH2O
P INSP 30 cmH2O
FREQUENCY 60 BPM
I-TIME 0.50 sec
OXYGEN 21% (Flush 23%)

On the ventilator:
Calibrate O2 sensor (21% and 100%), see
user instructions.
On the PF300:
Calibrate oxygen sensor
(see PF300 user instructions)

Check off O2 sensor calibration in PA-10-65

under 2nd device calibration.

Enter in Table 4.2 in PA-10-65.

Set oxygen values on the ventilator ac-
cording to the table.

95
Chapter
Complete device test
10

If the O2 displays are stable, read val-

ues on ventilator and PF300 and en-
ter in table.

96
Chapter
Complete device test
10

Testing the O2 flush function

Set the following values on the monitor for the

IPPV ventilator setting:
I-FLOW: 8.0 l/min
E-FLOW: 4 l/min
PEEP: 5 cmH2O
P INSP: 15 cmH2O
FREQUENCY: 60 BPM
I-TIME: 0.50 sec
O2: 21 %
Then press the O2 flush button and set the
O2-FLUSH value as follows:
O2-FLUSH: 30 %
Read the measured value for O2 after a few
seconds.

Enter in Table 4.3 PA-10-65.

97
Chapter
Complete device test
10

Testing the alarm functions

Connect standard tubing system with

Leoni test lung.

Make sure that all alarms are switched on.

(The mute alarm LED must not be on continu-
ously)

Make settings as described in PA-10-65 un-

der 5th alarm functions.

Check off results in PA-10-65 under 5th alarm

functions.

Testing the electrical safety in accordance with IEC

60601-1 or VDE 0751

Proceed in accordance with PA-10-65 Sec-

tion 6.

98
Chapter
Calibration
11

11. Calibration

General

Procedure

The procedure for complete calibration is described be-

low, and the results of the corresponding tests must be
recorded in test instruction PA-10-68.

Required test equipment

Special test procedures and instruments are required to

conduct the testing.

In general, only test instruments that are regularly

checked and calibrated by certified calibration service to
guarantee that they have the required accuracy.

The following equipment is required:

ETU-II electronic tester (if available)

PF300 flow analyser (IMT)

Transducer (e.g. Rüsch art. no. 065-518)

Leoni test lung (art. no. 0217027)

Required documents

PA-10-68 calibration protocol

99
Chapter
Calibration
11

Calibration

The device must be calibrated every 12 months or after

replacement of the controller software (PIC processors) or
any other actions that could influence the calibration.

Calibration with ETU

Connect ventilator and electronic tester to a

230 V power supply.
Connect a sensor cable to the socket marked
sensor on the ETU and the socket marked
sensor on the ventilator.
Connect the double O2 sensor on the air out-
put of the ventilator to the PRESSURE/OZ
socket of the ETU with the corresponding
adapter cable.

Set the ETU rotary switch to position 0.

Switch on ETU and ventilator.
The logo appears on the monitor and the in-
ternal self-test is run.
Then the screen with ventilator settings ap-
pears.
After a short time the monitor switches to
SYSTEM ALARM.

Press and hold Softkey F1 and Mute Alarm

button simultaneously until SYSTEM
ALARMS NOT ACTIVE is displayed at bot-
tom left.

Switch to the SETTINGS screen with the

Calibration/Settings button.
Press and hold the Softkey F3 and the Mute
Alarm button simultaneously to switch to the
SYSTEM DIAGNOSTICS screen.

100
Chapter
Calibration
11

Set the ETU rotary switch to position CAL.

Press and hold the SYSTEM CAL button on
the ventilator.
Now the calibration is automatically run (but-
ton can be released).
At the end of the calibration the screen shows
the message SYSTEM CALIBRATED.

Set the ETU rotary switch to position 0.

Read the values OFFS and SCL from ADC0/I

and ADC1/E and enter the readings in the
PA-10-68 calibration protocol at 1.1.

Read the values for P_AIR, P_OXY and

P_MIX and enter them in PA-10-68 calibration
protocol at 1.5.

Turn O2 switch on the ETU to the left stop.

Read values for OXY1 and OXY2 in the

DATA (21% O2) field and enter in the PA-10-
68 calibration protocol at 1.3.

Turn O2 switch on the ETU to the right stop.

Read values for OXY1 and OXY2 in the

DATA (100% O2) field and enter in the PA-10-
68 calibration protocol at 1.4.

Switch to the graphic display on the ventilator.

Press the NUMERIC key to select the
AVERAGE VALUES display.
Set the ETU rotary switch to position 5.
Wait for the displayed numeric values to stabi-
lise.

101
Chapter
Calibration
11

Read the values for MV, VTe and FREQ and

enter them in PA-10-68 calibration protocol at
1.6.

Read the values for OFFS and SCL from

PPROX enter them in PA-10-68 calibration
protocol at 1.2.

The process is complete.

102
Chapter
Calibration
11

Calibration without ETU

Switch to the SETTINGS screen with the

Calibration/Settings button.
Press and hold the Softkey F3 and the Mute
Alarm button simultaneously to switch to the
SYSTEM DIAGNOSTICS screen.

Press and hold the SYSTEM CAL button on

the ventilator.
At the end of the calibration the screen shows
the message NOT CALIBRATED.

The values are automatically set to the

default.

Read the values OFFS and SCL from ADC0/I

and ADC1/E and enter the readings in the
PA-10-68 calibration protocol at 1.1.

Read the values for P_AIR, P_OXY and

P_MIX and enter them in PA-10-68 calibration
protocol at 1.5.

Press and hold the 0 cmH20 button until 

appears.

The pressure measurement tube must be

disconnected during this procedure.

103
Chapter
Calibration
11

Connect the pressure input nipple on the ven-

tilator to the transducer and pressure gauge
and apply a pressure of 60 cmH2O.

If a transducer is not available, discon-

nect pressure measurement tube.

Press and hold the 60 cmH20 button until 

appears.

Read the values for OFFS and SCL from

PPROX enter them in PA-10-68 calibration
protocol at 1.2.

The process is complete.

104
Chapter
Calibration
11

Calibration of the proximal pressure sensor on the

blender control board

Open the device so the mixer control board is

visible.
Replacing the blender P. 38

Connect device
Press and hold Softkey F1 and Mute Alarm
button simultaneously until SYSTEM
ALARMS NOT ACTIVE is displayed at bot-
tom left.

A compressed air supply is not required.

Press and hold the Softkey F3 and the Mute

Alarm button simultaneously to switch to the
SYSTEM DIAGNOSTICS screen.

105
Chapter
Calibration
11

Disconnect the centre silicone pressure tube

from the pressure sensor.

The pressure here is then 0 cmH2O.

Locate the value P-MIX on the right side in

the system diagnostics screen.

Adjust the potentiometer screw on the bottom

potentiometer with the adjustment tool (a
screwdriver can also be used) so P-MIX
shows a value between 40 … 42.

Read value of P-MIX and enter it in the PA-

10-68 calibration protocol at 2.1.

Connect transducer to the pressure sensor

and set a pressure of 60 cmH2O.
Adjust the potentiometer screw on the top
potentiometer with the adjustment tool (a
screwdriver can also be used) so P-MIX
shows a value between 653 … 657.

Read value of P-MIX and enter it in the PA-

10-68 calibration protocol at 2.2.

106
Chapter
Alarms & troubleshooting
12

12. Alarms & troubleshooting

The ventilator has four types of alarms: patient alarms,

sensor alarms, system alarms and the disconnection
alarm. They are assigned various priorities depending on
the urgency.

The user can only set the alarm limits for patient alarms.

Setting range & calculation method

Setting ranges of alarm limits

MV [l] : 0.05 – 5.0

calculated minute volume : 0.00 – 5.0

VOLUME LIMIT VTi [ml] : 2.0 -250 and OFF

volume limit (upper limit of possible
breath volume)

LEAK [%] : 8 -60 and OFF

percentage breathing gas loss in ventila-
tion hoses

FREQ [1/min] : 10 -220 and OFF

number of breaths per minute (breathing
frequency)

APNEA [sec] : 6 -20 and OFF

time in seconds after which a breathing
stop triggers an alarm

P [cmH2O] : 1-60
limits between which the inspiration
: (-10) – 20
pressure must be set

107
Chapter
Alarms & troubleshooting
12

Calculation of the automatic alarm limits:

MV [l] : 85% above the measured minute volume

calculated minute volume
: 50% above the measured minute volume

VOLUME LIMIT VTi [ml] : 30% above measured breath volume

volume limit (upper limit of possible breath
volume)

LEAK [%] : 50% above the measured high leak to the maxi-
percentage breathing gas loss in ventila- mum value of 50% high leak
tion hoses

FREQ [1/min] : 50% above measured frequency

number of breaths per minute (breathing
frequency)

APNEA [sec] : 10 s
time in seconds after which a breathing
stop triggers an alarm

P [cmH2O] : 3 points above set pressure

limits between which the inspiration pres-
: 3 points below set pressure
sure must be set

108
Chapter
Alarms & troubleshooting
12

Setting alarms
All alarm limit settings are retained for 12 hours after
switching off the device.

Setting patient alarms automatically

1. Press the alarm limit button to switch to the alarm

limit monitor.

either
2. Press AUTOSET ALL.
All (not-shutoff) alarm limits are automatically set
depending on the current measured values.
The alarm limit values are displayed after approxi-
mately one minute.

or
3. Select the alarm limit that you want to set automati-
cally.
4. Press AUTOSET SINGLE.
The selected alarm limit is automatically set de-
pending on the current measured values.
The alarm limit value is displayed after approxi-
mately one minute.

109
Chapter
Alarms & troubleshooting
12

Setting patient alarms automatically

5. Press the alarm limit button to switch to the alarm

limit monitor.
6. Set the alarm limits manually.

Setting alarm volume

The alarm volume can be set to two levels.

7. Press the volume icon.

Loud:

Soft:

110
Chapter
Alarms & troubleshooting
12

Acknowledging alarms

Acknowledging patient alarms

An error message and a black bell icon signal the

alarm.

The alarm is also signalled by a flashing red light

(alarm LED) and an alarm sound.
Only the latest alarm is shown.

1. If necessary, mute the alarm to correct the cause

of the alarm.
The alarm is muted for two minutes. While it is
muted the LED on the mute alarm button is yellow
and the alarm LED remains red.

2. Correct the cause of the alarm.

Alarm messages & troubleshooting
The bell icon beside the limit value that caused the
alarm is no longer displayed in black.
3. Acknowledge the alarm by pressing .
The bell icon disappears.
The alarm LED is off.

After two minutes the alarm is automatically can-

celled.

111
Chapter
Alarms & troubleshooting
12

Acknowledging sensor alarms

Sensor alarms have a higher priority than patient
alarms and may therefore interrupt the patient alarm.

An error message describes the alarm.

The alarm is also signalled by a flashing red light

(alarm LED) and an alarm sound.
Only the latest alarm is shown.

4. Correct the cause of the alarm.

The red alarm LED is off.
5. Acknowledge the alarm by pressing the mute
alarm button.
The yellow light on the mute alarm button is off.

After five minutes the alarm is automatically can-

celled.

112
Chapter
Alarms & troubleshooting
12

Acknowledging system alarms

System alarms have a higher priority than patient
alarms and may therefore interrupt the patient alarm.

An error message describes the alarm.

The alarm is also signalled by a flashing red light

(alarm LED) and an alarm sound.
Only the latest alarm is shown.

6. Correct the cause of the alarm.

Error messages – system alarms P. 117
The red alarm LED is off.
7. Acknowledge the alarm by pressing the mute
alarm button.
The yellow light on the mute alarm button is off.
8. Close the SYSTEM ALARM monitor by pressing
.

After five minutes the alarm is automatically can-

celled.

113
Chapter
Alarms & troubleshooting
12

Alarm messages & troubleshooting

Displaying alarm messages

Patient alarms Sensor alarms

System alarms Disconnection alarms

Tube obstruction alarms

114
Chapter
Alarms & troubleshooting
12

Alarm priorities

The device has two priorities depending on the urgency of

the alarm message and identifies each with a specific
sound.

Priority 1: Requires immediate action to prevent a life-threatening

event (such as disconnected tubing). The alarm
sounds in rapid succession.

Priority 2: Requires quick action to prevent a life-threatening

event (such as patient alarm). Act appropriately; the
action must be completed after no more than two min-
utes. The alarm sounds in slow succession.

Error messages – patient alarms

Alarm message Possible causes Possible remedies

OXYGEN VALUE

O2 sensor fault
Inform service
DIVERGENCE

Patient no longer breathes
Remove stenosis

APNEA spontaneously
Change ventilation type (

Stenosis in/after tubing CONTROL)

Hyperventilation
Reset alarm limits

HIGH BREATH RATE
Additional spontaneous
Reset breath rate setting
breathing by patient
Reset ventilation type

Exhalation valve membrane

Install membrane correctly
PRESSURE TOO HIGH installed incorrectly or re-
in exhalation valve
versed

PRESSURE TOO LOW
Leak at y-piece
Check for leaks

INPUT PRESSURE
No pressure in oxygen tube

Check oxygen tube
OXYGEN SUPPLY or pressure too low

115
Chapter
Alarms & troubleshooting
12

Alarm message Possible causes Possible remedies

INPUT PRESSURE
No pressure in air tube or

Check air tube
AIR SUPPLY pressure too low

No pressure in supply tube

INPUT PRESSURE
Check oxygen tube
or pressure too low
BLENDER
Inform service

Internal error

EXHALATORY TUBE
Exhalatory tube kinked
Check exhalatory tube

Leak in device-side tubing

(before flow sensor, at y-
Check inspiration tube and
INSPIRATION PRESSURE piece) inspiration connection
NOT REACHED
Leak at inspiration valve
Check tube

High leak
Increase flow

Flow too low

INSPIRATORY TUBE
Inspiratory tube kinked
Check inspiratory tube

Change in lung compli-
Reduce PIP or increase

LOW MINUTE VOLUME
ance limit values

Change in lung compli-
Increase PIP or increase

LOW MINUTE VOLUME
ance limit values

SENSOR DEVIATION
Check excess pressure

Pressure tube kinked
PROXIMAL PRESSURE valve

VOLTAGE

Error in voltage
Inform service
MONITORING

Cancel volume limiting

Change in lung compli-
VOLUME LIMITED or
ance

Reduce pressure

Tube too small
Replace tube

HIGH LEAK

Air leak in tube
Check blocking

116
Chapter
Alarms & troubleshooting
12

Error messages – system alarms

System alarm types OPERATING ERRORS

INPUT PRESSURE
No pressure in oxygen line or pressure too low

OXYGEN SUPPLY

INPUT PRESSURE
No pressure in air line or pressure too low

AIR SUPPLY

EXHALATION
Exhalation tube blocked or kinked

TUBE

INSPIRATORY
Inspiratory tube blocked or kinked

TUBE

Gas supply failure

Ventilation stop!
If a gas supply fails the device does not automatically switch to the remain-
WARNING
ing gas.

Apply manual ventilation immediately if the gas supply fails (use a man-
ual ventilator if necessary).

System alarm types DEVICE ERRORS

OXYGEN VALUE
Measured oxygen value does not conform to the

DIVERGENCE value set in the ventilation parameters

INPUT PRESSURE
Input pressure at blender is too low

BLENDER

INTERNAL ERROR
An internal device error has occurred

OXYGEN SENSOR
Oxygen sensor is defective/not connected/used

DEFECT/USED

SENSOR DEVIATION
Deviation between oxygen sensors

PROXIMAL PRESSURE

VOLTAGE
The input voltage is too low

MONITORING

EXCESS PRESSURE
Excess pressure was detected

117
Chapter
Alarms & troubleshooting
12

Error messages – disconnection alarms

Alarm message Possible causes Possible remedies

Inspiratory tube discon-

nected

Exhalatory tube discon-
PATIENT DISCONNECT nected
Check tubing system

Pressure tube disconnected

Tubing disconnected

Error messages – tube obstruction alarms

Alarm message Possible causes Possible remedies

Tube is obstructed
TUBE OBSTRUCTION
Check tubing system

Tube is blocked

Error messages – sensor alarms

Malfunction of sensors
Uncalibrated sensors may result in the patient receiving too much or
too little oxygen.
WARNING
Calibrate the sensors after every change.

O2 sensor
Alarm message Possible causes Possible remedies

REPLACE O2 SENSOR
Replace sensor within the

Sensor is nearly consumed
SHORTLY next four weeks

OXYGEN SENSOR Oxygen sensor is used and

Replace oxygen sensor
DEFECT/USED must be replaced

118
Chapter
Alarms & troubleshooting
12

Flow sensor

Replacing flow sensor with PSV, SIMV or SIPPV

Changing ventilation mode

If the flow sensor is replaced during operation in PSV, SIMV or SIPPV
ventilation mode, the device automatically switches to controlled ventila-
tion mode.

Alarm message Possible causes Possible remedies

Break in sensor cable

FLOW SENSOR DEFECTIVE
Replace flow sensor or
or in wire in sensor ca-
CHECK FLOW SENSOR sensor cable
ble

REPLACE FLOW SENSOR

Flow sensor dirty
Clean flow sensor
AND CALIBRATE

The flow sensor or the

Connect flow sensor
FLOW SENSOR flow sensor cable is
and sensor cable cor-
DISCONNECTED not correctly con-
rectly or replace
nected

Clean flow sensor

Aspirate any water in
the tubing system

Check the environment
CLEAN FLOW SENSOR
Flow sensor dirty around the sensor (y-
piece, tubing) and
clean if necessary

Calibrate sensor again
after replacement

119
Chapter
Technical data
13

13. Technical data

The device has been developed in accordance with the

EN60601-1-4 guidelines. All parameters that could cause
danger to the patient are redundantly monitored by hard-
ware safety components.

Adjustment ranges of ventilation parameters

IPPV/IMV SIMV SIPPV CPAP
Breath rate
6 .. 200 2 .. 100 2 .. 100 -
FREQUENCY [BPM]
Inspiratory time
0.10 .. 2.00 0.10 .. 2.00 0.10 .. 2.00 -
I TIME [sec]
Expiratory time
0.20 .. 10.00 0.50 .. 30.00 0.20 .. 30.00 -
E TIME [sec]
Inspiratory flow
1 .. 32 1 .. 32 1 .. 32 -
I-FLOW [l/min]
Expiratory flow
2 .. 10 2 .. 10 2 .. 10 -
E-Flow [l/min]
CPAP
- - - 4 .. 10
MINFLOW [l/min]
Inspiratory pressure
6 .. 60 6 .. 60 6 .. 60 -
P/INSP [cmH2O]
Backup pressure
- - - 6 .. 60
P/BACK [cmH2O]
Positive, end expiratory pressure
0 .. 20 0 .. 20 0 .. 20 -
PEEP [cmH2O]

CPAP [cmH2O] - - - 1 .. 20

O2 concentration
21 .. 100 21 .. 100 21 .. 100 21 .. 100
OXYGEN [%]
O2 concentration of oxygen flush
23 .. 100 23 .. 100 23 .. 100 23 .. 100
O2 FLUSH [%]
Volume trigger for detection of sponta-
neous breathing - 10 .. 30 10 .. 30 -
TRIGGER [% VTi]
Backup breaths
- - - 1 .. 5
BACKUP

120
Chapter
Technical data
13

Resistance values

Resistance values

System resistance at 30 l/min < 20 mbar/l/s

Inspiratory resistance < 12 mbar/l/s

Expiratory resistance < 8 mbar/l/s

Accuracy of value display (ATPD∗)

Accuracy of measured value display

Peak pressure (P max)

Measurement range 0-100 cmH2O
Resolution 1 cmH2O
Accuracy ±4 %

Average pressure (P average)

Measurement range 0-100 cmH2O
Resolution 1 cmH2O
Accuracy ±4 %

Positive endexpiratory pressure

(PEEP) -10-100 cmH2O
Measurement range 1 cmH2O
Resolution ±4 %
Accuracy

Minute volume (MV)

Measurement range 0-99.9 l

Resolution 10 ml
from 10 l 100 ml
Accuracy ±8 %

∗
environmental temperature and pressure, dry

121
Chapter
Technical data
13

Tidal volume (VTi)

Measurement range 0-999 ml

Resolution 0.1 ml (at VTe < 100 ml)
1 ml (at VTe >= 100 ml)
Accuracy ±8 %

Minute volume (MV)

Tube leakage (LEAK)

Measurement range 10-50 %
Resolution 5%
Accuracy ±10 %

Dynamic compliance (DYN COMPL)

Measurement range
Resolution 0-500 ml/cmH2O
Accuracy 0.1 ml/cmH2O
±8 %

Airway resistance (RESISTANCE)

Measurement range 0-5000 cmH2O/l/s
Resolution 0.1 cmH2O/l/s
Accuracy ±8 %

Oxygen concentration (OXYGEN)

Measurement range 18-100 %
Resolution 1%
Accuracy ±3 % (Vol.)

Dimensions and weight

Dimensions and weight

WxHxD 25.5 cm x 22 cm x 34 cm

Weight 9.7 kg

Connections

Connections

Compressed air supply 2.0-6.5 kPa x 100 (bar)

Oxygen supply 2.0-6.5 kPa x 100 (bar)

Power supply 100-240 VAC, 50/60Hz

122
Chapter
Technical data
13

Environmental conditions

Environmental conditions

In operation
Temperature 15 - 35°C
Air pressure 700 - 1060 hPa
Relative humidity 30 - 90 %, non-condensing

Storage and transport

Temperature -20 - 60°C
Air pressure 500 - 1060 hPa
Relative humidity 10 - 90 %, non-condensing

Device service life

8 years

123
Chapter
Pneumatic diagram
14

14. Pneumatic diagram

Legend

1 Sinter filter

2 Pressure regulator

3 Pressure transducer

4 Air / oxygen blender

5 Blender solenoid valve

(10 x Air, 10 x Oxygen)

6 Sapphire nozzle (10 x

Air, 10 x Oxygen)

7 Check valve (as re-

quired, e.g. the patient
can inhale with this
valve in case of gas fail-
ure)

8 Bleed valve

9 Pneumatic overpressure
valve (pop-off)

10 Double O2 measure-
ment cell (module for
autonomous O2 calibra-
tion)

11 Pressure transducer in
inspiration side

12 Proximal pressure
transducer on Y-piece

13 Expiration valve

14 Microfilter

124
Chapter
Main board circuit diagram
15

15. Main board circuit diagram

125
Chapter
Accessories & spare parts
16

16. Accessories & spare parts

List of accessories and spare parts

0011070-1 O2 pressure tubing with removable connec-
tor, neutral standard, black
0011071-1 Air pressure tubing with removable connec-
tor, neutral standard, black

0011070-2 O2 pressure tubing with removable connec-

tor, ISO 32, white
0011071-2 Air pressure tubing with removable connec-
tor, ISO 32, white

0217010 Trolley

0217015-3 Patient tubing system for Fisher & Paykel

MR850, disposable, with MR290 humidifier
0217015-4 Patient tubing system, without humidifier
and tube heater
0217015-5 Patient tubing system, heated, for Fisher &
Paykel MR850, multi-use, for disposable
water chamber (initial system + connector
cord)
0217015-6 Patient tubing system, heated, for Fisher &
Paykel MR850, multi-use, for disposable
water chamber (spare system without con-
nector cord)
0217015-8 Patient tubing system, heated, for Fisher &
Paykel MR850, multi-use, for multi-use
water chamber
0217015-9 Patient tubing system, unheated, for Fisher
& Paykel MR850, multi-use, for multi-use
water chamber

126
Chapter
Accessories & spare parts
16

0217026-1 Leoni2 exhalatory valve

0217038 Membrane for exhalatory valve

0217031 Oxygen measurement cell

0217011 Flow sensor

0217012 Flow sensor connection cord
910AG 138 y-piece

0217027 Leoni test lung

8409742 Small test lung

127
Chapter
Accessories & spare parts
16

065-518 Pressure transducer (Rüsch)

900MR 858 (1) Electrical adapter for multi-use tubing

systems
900MR 859 (2) Electrical adapter for disposable tubing
systems
900MR 869 (3) Dual temperature and flow measure-
ment probe
810AG150 (4) Pressure measurement tubing
0217012 (5) Flow sensor connector cord

910BM 010 Tube adapter

900MR088 Clamp (holder for MR850 and water recy-

cler)
900MR850 MR850 humidifier

900MR290 Water recycler for Leoni

0217523 Leoni2 bottom housing

0217524 Leoni2 patient section panel

0217522 Leoni2 housing cover

0217521 Leoni2 front housing

0217041 Leoni rotary knob

0217200 Leoni PC/104 module (processor board)

0208900 Leoni sensor board

0217046 Leoni power supply

0217540 Leoni2 main board

0217545 Leoni2 line filter

128
Chapter
Accessories & spare parts
16

0217546 Leoni 2 battery pack

0217547 Leoni 2 battery board

0217550 Leoni2 blender (O2 and AIR)

0217552 Blender control board

0217554 Leoni2 alpha dial knob

0216013 Leoni display

0080500 Leoni2 foil keyboard

0217556 Leoni2 pressure reducer (Norgren)

0217560 Leoni2 oxygen bypass module

0217070 EPROM HI (M27C1001)

0217071 EPROM LO (M27C1001)

0170512 Monitor PIC (PIC16F877) 40 pins

0170513 Control PIC (PIC16F876) 28 pins

129
Chapter
Accessories & spare parts
16

Overview of tubing systems

Art. no. Article 0217015- 0217015- 0217015- 0217015- 0217015-

4 5 6 8 9

812BG511 Tube with heater 0 1 1 1 0

T06001019 Silicone ventilation tube 0 0 0 0 0
60cm/19mm
T06001010 Silicone ventilation tube 4 1 1 1 2
60cm
T04501010 Silicone ventilation tube 0 1 1 2 2
45cm
T04501019 Silicone ventilation tube 0 1 1 0 1
45cm/19mm
910AG138 Neonatal y-piece 1 1 1 1 1
900TM010 Children/paediatric water 0 1 1 1 2
trap, 10mm
810AG150 Pressure measurement tube 1 1 1 1 1
900MR869 Temperature probe 0 1 0 0 0
900MR858 Adapter cable for tube 0 1 0 0 0
heater
900BM010 Adapter for connection 4 2 2 2 2
10mm/10mm
50000- Gooseneck tube 2 2 2 2 2
03058E
900MR830 Adapter for temperature 0 1 1 1 0
sensor
0217111 Connector straight 0 0 0 1 1
15mm/10mm,WK multipath

130
Heinen + Löwenstein GmbH
Arzbacher Strasse 80
56130 Bad Ems
Germany

Phone: 0049 (0)2603 9600-0

Fax:: 0049 (0) 2603 9600-50
Email: [email protected]