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H&L LEONI 2 Service Manual en
H&L LEONI 2 Service Manual en
Leoni 2
2006-11-16
Contents
Cleaning device.............................................18
9. Software update ........................ 71
The component groups (type A, B and
C)...................................................................19 Replacing the processors...........................71
It includes:
Information
Information is provided to supplement the instructions for
actions.
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
CAUTION
Storage of documentation
Additional information
2
Chapter
General safety instructions
2
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.
3
Chapter
General safety instructions
2
Device check before operation Device malfunctions may cause death or permanent
injury to the patient.
Always check the ventilator before operation.
4
Chapter
Overview of the device
3
4
1. Sensor board
3 2. PC/104 module
3. Power module
4. Connection cable for control panel
1 2
5
Chapter
Overview of the device
3
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
7
Chapter
Overview of the device
3
Front of device
8
Chapter
Overview of the device
3
Rear of device
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
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.
Every 12 months
11
Chapter
Service and maintenance intervals
4
Every 3 years
Every 10 years
Standard services
Calibration
Complete device test with protocol
12
Chapter
Opening the device
5
Safety instructions
13
Chapter
Opening the device
5
Required tools
14
Chapter
Opening the device
5
15
Chapter
Standard services
6
6. Standard services
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.
16
Chapter
Standard services
6
17
Chapter
Standard services
6
Cleaning device
18
Chapter
Standard services
6
1. TYPE A:
The Type A sterilisable components installed near the pa-
tient with indirect contact to mucous membranes are the
following:
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:
3. TYPE C:
The type C components installed near the patient and with
sensitive surfaces are the following:
19
Chapter
Standard services
6
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.
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:
20
Chapter
Standard services
6
b. Manual cleaning:
Note:
21
Chapter
Standard services
6
6. Drying
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
8. Sterilisation
Steam-sterilise the Type A components in an
autoclave at
134°C, 3 bar, 5 min.
12. Commissioning
22
Chapter
Standard services
6
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
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
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
8. Sterilisation
Steam-sterilise the TYPE A components in an
autoclave at
134°C, 3 bar, 5 min.
12. Commissioning
24
Chapter
Standard services
6
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.
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
12. Commissioning
26
Chapter
Standard services
6
Surface disinfection:
Incidin Extra N (Henkel ECOLAB)
Observe the manufacturer’s directions for use
Disinfection of TYPE A:
SECUSEPT or SECUSEPT FORTE S from
ECOLAB
Observe the manufacturer’s directions for use
Disinfection of TYPE B:
27
Chapter
Standard services
6
Visual inspection
Visual inspection
28
Chapter
Standard services
6
29
Chapter
Standard services
6
30
Chapter
Replacing components
7
7. Replacing components
Required tools
31
Chapter
Replacing components
7
32
Chapter
Replacing components
7
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.
33
Chapter
Replacing components
7
Uncalibrated sensor
Uncalibrated flow sensors may result in the patient receiving too much
or too little oxygen.
WARNING Calibrate the sensor after replacement
4. After replacement:
Press FLOW SENSOR ACTIVATE.
5. Calibrate the sensor.
34
Chapter
Replacing components
7
Required tools
35
Chapter
Replacing components
7
2
1
36
Chapter
Replacing components
7
37
Chapter
Replacing components
7
Required tools
38
Chapter
Replacing components
7
39
Chapter
Replacing components
7
40
Chapter
Replacing components
7
10. Unscrew the four hex screws (1) with the socket
(size 5.5).
1
41
Chapter
Replacing components
7
14. Unscrew the four screws (1) that hold the blen-
der unit (2) with a Philips screwdriver.
1
2
42
Chapter
Replacing components
7
43
Chapter
Replacing components
7
Required tools
44
Chapter
Replacing components
7
45
Chapter
Replacing components
7
46
Chapter
Replacing components
7
47
Chapter
Replacing components
7
48
Chapter
Replacing components
7
1 2
49
Chapter
Replacing components
7
50
Chapter
Replacing components
7
Required tools
1 x soldering iron
51
Chapter
Replacing components
7
52
Chapter
Maintenance / repair
8
8. Maintenance / repair
Required tools
53
Chapter
Maintenance / repair
8
54
Chapter
Maintenance / repair
8
55
Chapter
Maintenance / repair
8
Required tools
56
Chapter
Maintenance / repair
8
57
Chapter
Maintenance / repair
8
58
Chapter
Maintenance / repair
8
Required tools
59
Chapter
Maintenance / repair
8
60
Chapter
Maintenance / repair
8
Required tools
61
Chapter
Maintenance / repair
8
62
Chapter
Maintenance / repair
8
Required tools
63
Chapter
Maintenance / repair
8
64
Chapter
Maintenance / repair
8
Required tools
65
Chapter
Maintenance / repair
8
66
Chapter
Maintenance / repair
8
Required tools
67
Chapter
Maintenance / repair
8
1
2
68
Chapter
Maintenance / repair
8
Replacing fuses
Required tools
69
Chapter
Maintenance / repair
8
70
Chapter
Software update
9
9. Software update
Required tools
1 x IC extractor
71
Chapter
Software update
9
72
Chapter
Software update
9
73
Chapter
Software update
9
Required tools
1 x IC extractor
74
Chapter
Software update
9
Note the correct labels (HI and LO) and the cor-
rect alignment of the ICs´.
75
Chapter
Software update
9
76
Chapter
Software update
9
77
Chapter
Software update
9
78
Chapter
Software update
9
79
Chapter
Software update
9
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 %
80
Chapter
Software update
9
81
Chapter
Complete device test
10
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
EN 60601-1
EN 46001
MPG (German medical devices act)
CE mark
82
Chapter
Complete device test
10
Procedure
Required documents
83
Chapter
Complete device test
10
Symbols
Run test
Clean / disinfect
84
Chapter
Complete device test
10
Procedure
85
Chapter
Complete device test
10
86
Chapter
Complete device test
10
Switch on device
87
Chapter
Complete device test
10
88
Chapter
Complete device test
10
89
Chapter
Complete device test
10
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.
91
Chapter
Complete device test
10
92
Chapter
Complete device test
10
93
Chapter
Complete device test
10
94
Chapter
Complete device test
10
On the ventilator:
Calibrate O2 sensor (21% and 100%), see
user instructions.
On the PF300:
Calibrate oxygen sensor
(see PF300 user instructions)
95
Chapter
Complete device test
10
96
Chapter
Complete device test
10
97
Chapter
Complete device test
10
98
Chapter
Calibration
11
11. Calibration
General
Procedure
Required documents
99
Chapter
Calibration
11
Calibration
100
Chapter
Calibration
11
101
Chapter
Calibration
11
102
Chapter
Calibration
11
103
Chapter
Calibration
11
104
Chapter
Calibration
11
Connect device
Press and hold Softkey F1 and Mute Alarm
button simultaneously until SYSTEM
ALARMS NOT ACTIVE is displayed at bot-
tom left.
105
Chapter
Calibration
11
106
Chapter
Alarms & troubleshooting
12
The user can only set the alarm limits for patient alarms.
P [cmH2O] : 1-60
limits between which the inspiration
: (-10) – 20
pressure must be set
107
Chapter
Alarms & troubleshooting
12
LEAK [%] : 50% above the measured high leak to the maxi-
percentage breathing gas loss in ventila- mum value of 50% high leak
tion hoses
APNEA [sec] : 10 s
time in seconds after which a breathing
stop triggers an alarm
108
Chapter
Alarms & troubleshooting
12
Setting alarms
All alarm limit settings are retained for 12 hours after
switching off the device.
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
Loud:
Soft:
110
Chapter
Alarms & troubleshooting
12
Acknowledging alarms
111
Chapter
Alarms & troubleshooting
12
112
Chapter
Alarms & troubleshooting
12
113
Chapter
Alarms & troubleshooting
12
114
Chapter
Alarms & troubleshooting
12
Alarm priorities
OXYGEN VALUE
O2 sensor fault Inform service
DIVERGENCE
115
Chapter
Alarms & troubleshooting
12
VOLTAGE
Error in voltage Inform service
MONITORING
116
Chapter
Alarms & troubleshooting
12
117
Chapter
Alarms & troubleshooting
12
Tube is obstructed
TUBE OBSTRUCTION Check tubing system
Tube is blocked
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
118
Chapter
Alarms & troubleshooting
12
Flow sensor
119
Chapter
Technical data
13
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
∗
environmental temperature and pressure, dry
121
Chapter
Technical data
13
WxHxD 25.5 cm x 22 cm x 34 cm
Weight 9.7 kg
Connections
Connections
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
8 years
123
Chapter
Pneumatic diagram
14
Legend
1 Sinter filter
2 Pressure regulator
3 Pressure transducer
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
125
Chapter
Accessories & spare parts
16
0217010 Trolley
126
Chapter
Accessories & spare parts
16
127
Chapter
Accessories & spare parts
16
128
Chapter
Accessories & spare parts
16
129
Chapter
Accessories & spare parts
16
130
Heinen + Löwenstein GmbH
Arzbacher Strasse 80
56130 Bad Ems
Germany