Lowenstein Medical leon plus User manual

leon plus
User manual
Rev. 3.11.13
from software version 3.11.x
As at 03.11.2022
Please read this instruction manual carefully
before using the device and keep it to hand at all
times!

Copyright ® 2022 Löwenstein Medical SE & Co. KG
Subject to change
03.11.2022
Löwenstein Medical SE & Co. KG
Arzbacher Straße 80
56130 Bad Ems, Germany
:
+49 2603/9600−0
:
+49 2603/9600−50
:
loewensteinmedical.com
User manual leon plus
Order no.: Ba-0301v311

Table of Contents
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3
Table of Contents
1. List of abbreviations............................................................................................................. 11
2. About this User manual........................................................................................................ 15
Validity of this instruction manual............................................................................................ 15
Essential information covered by the instruction manual........................................................ 15
Structure and purpose of the User manual............................................................................. 16
Description of options.............................................................................................................. 16
Retention of documentation .................................................................................................... 16
Further information.................................................................................................................. 16
3. Safety for you and the patient ............................................................................................. 17
User manual compliance ........................................................................................................ 17
Warnings ................................................................................................................................. 17
Residual hazards .................................................................................................................... 18
Messages to the manufacturer and authorities....................................................................... 19
Liability and guarantee............................................................................................................ 20
Classification of the device ..................................................................................................... 21
Maintenance instructions ........................................................................................................ 21
4. Device overview .................................................................................................................... 22
Intended use ........................................................................................................................... 22
Operating requirements....................................................................................................... 22
Forms of ventilation ............................................................................................................. 22
Anaesthesia systems........................................................................................................... 23
Contraindications................................................................................................................. 23
Guidelines and manufacturer's declaration – Electromagnetic emissions .......................... 24
Guidelines and manufacturer's declaration – Electromagnetic immunity ........................... 25
Device description................................................................................................................... 29
Overview.............................................................................................................................. 29
Patient module..................................................................................................................... 31
Anaesthetic vaporiser mounting .......................................................................................... 31
Ventilator ............................................................................................................................. 31
Railing system ..................................................................................................................... 32
Writing shelf, drawers, storage compartment...................................................................... 33
Tube and cable guides ........................................................................................................ 34
Delivery contents ................................................................................................................. 35
Operating instructions ............................................................................................................. 36
5. Operating concept ................................................................................................................ 37
Function levels ........................................................................................................................ 37
Icons........................................................................................................................................ 39
User interface.......................................................................................................................... 47
Concepts ............................................................................................................................. 47
Keypad ................................................................................................................................ 48
Touchscreen........................................................................................................................ 49
Rotary switch ....................................................................................................................... 51
Tab system .......................................................................................................................... 52
Title bar................................................................................................................................ 52

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HLM form of ventilation........................................................................................................ 53
MON form of ventilation ....................................................................................................... 53
Monitoring of muting of alarm .............................................................................................. 54
Screensaver......................................................................................................................... 54
Control elements and displays ................................................................................................ 55
Front..................................................................................................................................... 55
Options board ...................................................................................................................... 57
Device connections ................................................................................................................. 59
Description of device connections ....................................................................................... 59
Operation of the device connections ................................................................................... 60
Rear wall .............................................................................................................................. 63
Patient module......................................................................................................................... 64
Removing the patient module .............................................................................................. 64
Connection for ventilation tubes, anaesthesia gas scavenging system and ventilation bag
............................................................................................................................................. 65
Connection of the AGSS on the rear of the device.............................................................. 65
Connection for respiratory bellows, dome and CO2absorber, PEEP valve diaphragm cover,
flow sensors ......................................................................................................................... 66
APL valve............................................................................................................................. 67
Bronchial aspiration ................................................................................................................. 67
6. Preparations........................................................................................................................... 68
First installation........................................................................................................................ 68
Adaptation to ambient conditions......................................................................................... 68
Customer requirements at the application site (leon plus – Standard configuration).......... 69
Emergency power supply .................................................................................................... 70
Charging batteries................................................................................................................ 70
Out-of-operation for a longer period .................................................................................... 70
Preparation for start-up ........................................................................................................... 71
Gas connections .................................................................................................................. 71
Electrical connections .......................................................................................................... 77
Connection of the respiratory bellows and the dome .......................................................... 79
Removing and installing the CO2absorber.......................................................................... 79
Changing, emptying, filling the CO2absorber...................................................................... 80
Connection of the ventilation tubes...................................................................................... 82
Gas measurement ............................................................................................................... 83
Connection of the ventilation bag ........................................................................................ 86
Connection to the anaesthesia gas scavenging system...................................................... 87
Suspension bracket of the intake system on the rear of the device .................................... 89
APL valve............................................................................................................................. 90
Setting up the anaesthetic vaporiser ................................................................................... 90
Connection of the bronchial aspiration ................................................................................ 91
Connection of auxiliary devices ........................................................................................... 92
Connection of data communication ..................................................................................... 93
7. Start-up................................................................................................................................... 94
Short check (recommended by DGAI) .................................................................................... 95
Configuration (in standby) ....................................................................................................... 96

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Config tab ............................................................................................................................ 96
Volume tab .......................................................................................................................... 98
System Time tab.................................................................................................................. 99
Option tab .......................................................................................................................... 100
Configuration (during ventilation) .......................................................................................... 100
Config tab .......................................................................................................................... 100
Volume tab ........................................................................................................................ 101
Option tab .......................................................................................................................... 101
System configuration of the user interface........................................................................ 101
Service .................................................................................................................................. 106
Login.................................................................................................................................. 107
Service tab......................................................................................................................... 108
Configuration tab/page 1 ................................................................................................... 111
Configuration tab/page 2 ................................................................................................... 115
Procedure for saving the system configuration ................................................................. 116
Device check......................................................................................................................... 118
Selftest............................................................................................................................... 118
System test........................................................................................................................ 119
Short checklist before start-up........................................................................................... 119
Limited start-up option .......................................................................................................... 120
Turn on .................................................................................................................................. 120
System test ........................................................................................................................... 122
General information ........................................................................................................... 122
Operating states of the system test block ......................................................................... 123
Results of the selftest ........................................................................................................ 124
O2emergency dosing during the system test.................................................................... 124
External fresh gas outlet before the system test ............................................................... 125
Start of the system test...................................................................................................... 125
Skip/cancel system test (Quick start) ................................................................................ 126
Back to the system test from standby ............................................................................... 127
Execution of the system test ............................................................................................. 127
Passed system test and display of values for compliance and leakage rate .................... 128
System test not passed and detailed error display ........................................................... 128
Display of values for compliance and leakage rate........................................................... 129
Repeating individual system test blocks............................................................................ 129
Tightness of tube system and full system ......................................................................... 130
System test procedure .......................................................................................................... 131
FiO2calibration...................................................................................................................... 132
Start of FiO2calibration ..................................................................................................... 132
Execution of the FiO2calibration ....................................................................................... 132
Passed FiO2calibration ..................................................................................................... 132
FiO2calibration not passed ............................................................................................... 133
Alarm test .............................................................................................................................. 133
General information ........................................................................................................... 133
Test of alarm functions ...................................................................................................... 134
Power off ............................................................................................................................... 138

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O2emergency dosing during shutdown of the device ....................................................... 139
8. Ventilation ............................................................................................................................ 140
General information ............................................................................................................... 140
Compliance compensation ................................................................................................ 140
Patient categories .............................................................................................................. 140
Weight (IBW)...................................................................................................................... 141
Load default settings.......................................................................................................... 143
Behaviour of the Pinsp. Setting upon change to the PEEP settings .................................... 143
Moisture in the ventilation system...................................................................................... 144
Low flow and minimal flow ................................................................................................. 144
Fresh gas setting ................................................................................................................... 145
Fresh gas ecometer ........................................................................................................... 147
Borderline fresh gas settings ............................................................................................. 148
Setting of the anaesthetic vaporiser ...................................................................................... 148
Quick start ............................................................................................................................. 149
Manual operation during the boot process and the selftest............................................... 149
Execute quick start............................................................................................................. 150
Forms of ventilation ............................................................................................................... 151
Manual ventilation .............................................................................................................. 151
Mechanical ventilation ....................................................................................................... 157
Description of the forms of ventilation................................................................................ 162
9. Monitoring ............................................................................................................................ 175
General information ............................................................................................................... 175
Data ................................................................................................................................... 176
Alarm muting (mute) .......................................................................................................... 178
Limit values ........................................................................................................................ 178
Alarm messages ................................................................................................................ 178
Batteries ............................................................................................................................. 178
Device functions................................................................................................................. 178
Monitored data....................................................................................................................... 179
Measured values as graphical display............................................................................... 179
Tabular trend...................................................................................................................... 182
Event log ............................................................................................................................ 183
Measured values in a numerical display............................................................................ 184
Entry of age for MAC calculation ....................................................................................... 189
Manual selection of the narcotic gas ................................................................................. 190
Detection of triggered breaths ........................................................................................... 190
Loops (monitoring of lung function) ................................................................................... 191
10. Monitoring of device functions .......................................................................................... 192
Fresh gas blender.................................................................................................................. 193
Intact fresh gas blender ..................................................................................................... 193
Fresh gas blender in the event of failure of a carrier gas .................................................. 193
Display of damaged fresh gas blender .............................................................................. 194
Gas supply pressures............................................................................................................ 194
Central gas supply pressures ............................................................................................ 195

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Pressure display when supply from 10 L bottles............................................................... 196
Drive gas generator............................................................................................................... 197
Gas measurement................................................................................................................. 197
Fresh gas shortage ............................................................................................................... 198
Docking station with patient module ..................................................................................... 198
CO2absorber ........................................................................................................................ 198
Fans ...................................................................................................................................... 198
Batteries ................................................................................................................................ 199
Stopwatch ............................................................................................................................. 199
11. Alarms .................................................................................................................................. 200
General information............................................................................................................... 200
Display of current alarms................................................................................................... 200
Factory settings of the alarms ........................................................................................... 202
Alarm muting ......................................................................................................................... 204
Alarm muting 2 minutes..................................................................................................... 204
10 minute alarm muting..................................................................................................... 205
Alarm log ............................................................................................................................... 206
Limit values (patient alarm limits).......................................................................................... 207
Setting patient alarm limits manually................................................................................. 207
Adjustable alarm limits ...................................................................................................... 208
Display of apnoea duration................................................................................................ 208
Application area and increment of alarm........................................................................... 209
Adjusting alarm limits to current measured value (autoset) .............................................. 211
Alarm limits that are automatically followed ...................................................................... 212
Active alarms ..................................................................................................................... 212
List of alarm messages ......................................................................................................... 214
12. Errors and measures .......................................................................................................... 233
General information............................................................................................................... 233
Patient monitoring.............................................................................................................. 233
Pressure relief valve .......................................................................................................... 234
Defined safe state ................................................................................................................. 235
Patientsafe defined safe state ........................................................................................... 235
Failsafe defined safe state ................................................................................................ 236
Inoperability or failure of the device................................................................................... 237
Self check error search ......................................................................................................... 239
Gas supply error search .................................................................................................... 239
Self check error search ..................................................................................................... 239
Error search system test ....................................................................................................... 240
Error search gas type check.............................................................................................. 240
Error search fresh gas blender.......................................................................................... 241
Error search respirator ...................................................................................................... 243
Error search flow sensors.................................................................................................. 244
Error search circulation system ......................................................................................... 245
Error search FiO2calibration ............................................................................................. 248
External supply units failure .................................................................................................. 249
No central gas supply ........................................................................................................ 249

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Mains supply failure ........................................................................................................... 252
Failure of the anaesthesia gas scavenging system........................................................... 254
Failure of internal units .......................................................................................................... 255
Touchscreen failure ........................................................................................................... 255
Fresh gas dosing failure .................................................................................................... 256
Ventilator failure ................................................................................................................. 258
Gas measurement failed.................................................................................................... 259
Flow measurement failure ................................................................................................. 260
Pressure measurement failure........................................................................................... 261
13. Maintenance and servicing ................................................................................................ 262
General information ............................................................................................................... 262
Servicing by hospital staff...................................................................................................... 262
Change CO2absorber ....................................................................................................... 262
Change bronchial aspiration filter ...................................................................................... 262
Gas measurement maintenance (sidestream measurement) ........................................... 263
Flow sensor servicing ........................................................................................................ 265
PEEP valve diaphragm servicing....................................................................................... 266
Servicing of the insp./exp. valve diaphragms .................................................................... 267
Servicing of fans ................................................................................................................ 268
Servicing of reserve gas bottles and 10 L bottles.............................................................. 269
Disposal................................................................................................................................. 272
Disposal of gas .................................................................................................................. 272
Disposal of soda lime......................................................................................................... 272
Disposal of bronchial aspiration filter ................................................................................. 272
Disposal of water trap and sample line.............................................................................. 272
Disposal of O2sensor ........................................................................................................ 273
Disposal of flow sensor ...................................................................................................... 273
Disposal of valve diaphragm.............................................................................................. 273
Disposal of fan filter pad .................................................................................................... 273
Disposal of electric and electronic components of the device........................................... 273
Disposal of battery ............................................................................................................. 274
Changing and filling reserve gas bottles or 10 L bottles.................................................... 274
Maintenance by authorised service technicians.................................................................... 274
General information ........................................................................................................... 274
Servicing interval................................................................................................................ 275
Replacing and calibrating the O2cell................................................................................. 276
Side power measurement servicing................................................................................... 277
Maintenance of the high-pressure regulator ...................................................................... 279
Technical safety controls ................................................................................................... 279
14. Accessories ......................................................................................................................... 285
General information ............................................................................................................... 285
Replacement part .................................................................................................................. 286
Accessories ........................................................................................................................... 286
15. Product combinations ........................................................................................................ 287
General information ............................................................................................................... 287

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Auxiliary devices ................................................................................................................... 287
Mounting additional monitors ................................................................................................ 288
Anaesthetic vaporiser............................................................................................................ 288
Bronchial aspiration............................................................................................................... 288
Support arms......................................................................................................................... 289
PDMS .................................................................................................................................... 289
HIS ........................................................................................................................................ 289
AGSS .................................................................................................................................... 289
16. Appendix.............................................................................................................................. 290
Notes ..................................................................................................................................... 290
Gas flow plans....................................................................................................................... 292
Legend gas flow plans....................................................................................................... 292
Manual ventilation (patient module 0209100) ................................................................... 294
Mechanical ventilation (patient module 0209100)............................................................. 296
Manual ventilation (patient module 0209100hul200) ........................................................ 300
Mechanical ventilation (patient module 0209100hul200) .................................................. 302
Manual ventilation (patient module 0209100lm300) ......................................................... 306
Mechanical ventilation (patient module 0209100lm300) ................................................... 308
Calculation methods.............................................................................................................. 312
Pressure flow characteristics ................................................................................................ 314
Service life of replacement parts........................................................................................... 316
Life of soda lime ................................................................................................................ 316
Life of bronchial aspiration filter......................................................................................... 316
Gas measurement ............................................................................................................. 316
Life of the flow sensors...................................................................................................... 317
Life of the PEEP valve diaphragm..................................................................................... 317
Life of the insp./exp. valve diaphragms............................................................................. 317
Life of the fan filter pad...................................................................................................... 317
Service life of reusable CO2absorber ............................................................................... 317
Service life of inspection glasses ...................................................................................... 318
Lists and short instructions ................................................................................................... 319
Ordering replacement parts............................................................................................... 319
Ordering accessories......................................................................................................... 319
leon plus Short checklist before start-up ........................................................................... 319
leon plus Short operating instructions ............................................................................... 319
leon plus Technical safety controls checklist .................................................................... 319
17. Technical data ..................................................................................................................... 320
18. Index..................................................................................................................................... 337
Chapt er

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Chapter
1
List of abbreviations
Validity of this instruction manual
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11
1. List of abbreviations
Table 1: Abbreviations and Terms
Abbreviation, Term Description
A Breath-by-breath window
Agent Volatile anaesthetic
AGFS Anaesthetic gas scavenging system
AGS Anaesthetic gas aspiration
AIR Medical compressed air
APL valve Adjustable Pressure Limitation
Adjustable pressure-relief valve
AZV Tidal volume
BSF Breathing system filter
BTPS Body, Temperature, Pressure, Saturated
Measured values standardised to BTPS requirements refer to 37°C
(body temperature), current atmospheric pressure and 100% steam
saturation.
C20/C Compliance during the last 20% of the inspiration phase compared
with total compliance
(Measurement for overdistention of the lungs ≤1)
Calibration To calibrate an analyser, the analyser is checked and the deviation
from a standard (that is known to be correct) is determined.
Carrier gas Gas that is used as a fresh gas along with O2
General AIR or N2O
Cdyn Compliance (dynamic)
CGS Central gas system (supply) for O2, N2O and AIR
CO2Carbon dioxide
Compliance Lung elasticity
CPAP Continuous Positive Airway Pressure
Constant positive airway pressure
Cstat. Compliance (static)
Des. Volatile anaesthetic – desflurane
E Expiration
Enf. Volatile anaesthetic – enflurane
f, Freq. Frequency, number of breaths per minute

Chapter
1
List of abbreviations
Validity of this instruction manual
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Table 1: Abbreviations and Terms
Abbreviation, Term Description
FiO2Insp. oxygen measurement
FO Optical fibre cable
Fresh gas flow Sum of O2gas flows and carrier gas into the anaesthesia system
Hal. Volatile anaesthetic – halothane
HIS Hospital information system
HLM Heart-lung machine
I Inspiration
I:E Inspiration to expiration ratio
IBW Ideal body weight
IMV Intermittent Mandatory Ventilation
Volume-controlled ventilation
Insp. flow Inspiratory flow
Insp. vol Inspiratory volume
Iso. Volatile anaesthetic – isoflurane
Leak Difference between inspiratory and expiratory breath volume
(ventilation gas lost in ventilation tubes, on seals, cross-over points
and on the tube)
Loop
Displays of flow over pressure, volume over pressure or flow over
volume measured values in a coordinates system
Low flow Fresh gas flow ≤ 1000 ml/min and > 500 ml/min
MAC Minimum Alveolar Concentration
Minimal flow Fresh gas flow ≤ 500 ml/min
MON Monitoring mode (to monitor sufficient spontaneously breathing
patients)
MV Minute volume
N2ODinitrogen monoxide (nitrous oxide)
No. of charts Number of real-time curves (minimum 1, maximum 4)
O2Oxygen
O2flush Oxygen flush
Patient category
Adult
Fast selection of preconfigured ventilation parameter settings and
alarm limits for adult ventilation

Chapter
1
List of abbreviations
Validity of this instruction manual
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13
Table 1: Abbreviations and Terms
Abbreviation, Term Description
Patient category
Child
Fast selection of preconfigured ventilation parameter settings and
alarm limits for ventilation in children
Patient category
IBW
Fast selection of preconfigured ventilation pattern parameter settings
and alarm limits on entry of the ideal bodyweight (child alarm limits)
Paw Ventilation pressure
PCV Pressure Controlled Ventilation
Pressure-controlled ventilation
PDMS Patient Data Management System
PEEP Positive End Expiratory Pressure
Positive end-expiratory pressure
Pinsp. PCV to be reached
Plat./Plateau Percentage length of plateau during inspiration
PMean Mean ventilation pressure
PPeak Maximum ventilation pressure
PPlat./PPlateau Ventilation plateau pressure
Pressure units ▪100 kPa
▪1 atm
▪1 hPa
▪1 kPa
▪1 bar
▪1 mbar
▪1 mm Hg
= 1 bar
= approx. 1 kg/cm2(kp/cm2)
= 100 Pa
= approx. 10 cm H2O
= 1 kPa ×100
= approx. 1 cm H2O
= approx. 133 Pa
= approx. 1 atm
= approx. 1 cm H2O
Pressure units
(standard)
▪1 kPa ×100
▪1 Pa ×100
= 1 bar
= 1 mbar = approx. 1 cm H2O
PSV Pressure Support Ventilation
Pressure-supported ventilation
R/Resistance Airway resistance
Ratio system With N2O as the carrier gas, the minimum concentration setting for
O2= 25%
RDG Cleaning and disinfection device
Settings Settings
Sev. Volatile anaesthetic – sevoflurane
S−IMV Synchronized Intermittent Mandatory Ventilation
Triggered form of ventilation

Chapter
1
List of abbreviations
Validity of this instruction manual
14
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Table 1: Abbreviations and Terms
Abbreviation, Term Description
S−PCV Synchronized Pressure Controlled Ventilation
Triggered form of ventilation
t Time
Trig. Flow Flow needed to release the trigger
Trig. vol. Volume needed to release the trigger
Trigger Option of synchronising the ventilator of the anaesthesia workstation
with spontaneous patient breathing activity
USV Uninterrupted power supply
V Volume
V

Flow
Vapour anaesthetic vaporiser
VGA Video graphics array (computer graphics standard)
VTe Tidal volume expiration
VTG Tidal volume guarantee
VTi Tidal volume inspiration

Chapter
2
About this User manual
Validity of this instruction manual
leon plus- As at 03.11.2022 - 3.11.13
15
2. About this User manual
Validity of this instruction manual
This instruction manual applies to the following
products:
▪leon plus
These instructions for use also apply to all devices
with the manufacturer's name Heinen + Löwenstein
GmbH & Co. KG and with the manufacturer's
information Löwenstein Medical GmbH & Co. KG.
Essential information covered by the instruction
manual
This user manual describes the anaesthesia
workstation leon plus and its operation. It contains:
▪Information on the safe handling of the
anaesthesia workstation
▪An overview of all of the device components
▪A description of how to operate the device
▪A description of the monitor control elements
▪Information on
– Installation
– Start-up
– Operation
– Monitoring and alarms
– Errors and troubleshooting
– Servicing
– Accessories
Documentation for the leon plus anaesthesia system
encompasses:
▪leon plus instruction manual
▪leon plus, leon and leon mri hygiene instructions
▪Service Manual for leon plus, leon, leon mri
Rev. 2.4.2
▪Service manual supplementing Vers. 2.4.2
leon plus, leon, leon mri
▪leon plus Short check list/instructions before
start-up
▪leon plus, leon and leon mri List of accessories
and replacement parts
▪Checklist of technical safety controls for leon plus
The checklist, short instructions and copyable forms
can be found at the end of the document.

Chapter
2
About this User manual
Structure and purpose of the User manual
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3.11.13 - As at 03.11.2022 - leon plus
Structure and purpose of the User manual
The user manual will familiarise you, step-by-step,
with the operation of your anaesthesia workstation. All
of the available features are described.
Read through the user manual carefully, before you
begin to work with the anaesthesia workstation.
Continue to consult the user manual for your work
until you are perfectly sure of how to handle the
device and have completed all of the training
sessions successfully.
If you have detailed questions, the contents and index
will help you to find a subject quickly.
Tips supplement the handling instructions. They
suggest methods of operating the anaesthesia
workstation more efficiently and more simply under
proper safety conditions.
Description of options
This user manual contains descriptions of standard
and optional device equipment and features. No legal
claim may be derived from the description of this
option. You can find out which options are available in
your system from your Löwenstein Medical sales
partner.
Retention of documentation
Keep the documentation to hand at all times, in a
complete and readable condition, near to the device.
If the device is passed on, it must be accompanied by
the documentation. In the event of loss, contact
Löwenstein Medical customer services immediately.
Further information
If you have any questions or remarks regarding this
instruction manual or the device, please contact your
authorised regional specialist vendor or the
manufacturer directly.

Chapter
3
Safety for you and the patient
User manual compliance
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17
3. Safety for you and the patient
User manual compliance
Non-compliance with the user manual
Danger of harm to patients
▪Precise knowledge and compliance with this user manual is required
each time the device is used.
▪The device is intended for the described use only.
WARNING
This user manual is designed to help you, step-by-
step, to become familiar with the operation of your
anaesthesia workstation. Frequently used features
are described.
Read through the user manual carefully, before you
begin to work with the anaesthesia workstation.
Later on, when you are familiar with the basic
operation of the anaesthesia workstation, the user
manual will serve as a reference for detailed
questions. The contents and keywords index will help
you to find a subject quickly.
Warnings
!
ATTENTION indicates important information, non-compliance with which
could lead to damage to the device.
ATTENTION
CAUTION indicates a latent hazard that does not represent a direct threat
but can lead to physical injury if not avoided.
CAUTION
WARNING indicates a hazard that represents a direct threat and can lead
to severe injury or death if not avoided.
WARNING

Chapter
3
Safety for you and the patient
Residual hazards
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Residual hazards
Observe safety instructions and
warnings
For the proper and safe operation and use of the
device, it is absolutely essential that the safety
instructions and warnings, (→ "Warnings" p. 17)in
addition to this user manual, are read, understood
and fully observed by every user before the initial
start-up.
Operation by qualified staff The leon plus anaesthesia device may be operated
only by qualified specialist medical staff who have
been instructed how to operate the device, so that
they are able to take immediate action in the event of
malfunction.
Device malfunctions!
Death or permanent injury of the patient
▪During the use of the leon plus, an alternative ventilation system, e.g.
ventilation bag with mask, must always be available, preferably with an
O2tube connector.
▪If, in the event of a recognisable fault in the leon plus anaesthesia
device, it can no longer be guaranteed that life can be sustained, the
ventilation of the patient must be started promptly with independent
ventilation equipment, e.g. ventilation bag with mask.
▪A device check must be carried out beforehand each time the
anaesthesia workstation is used.
▪If a fault is established during the self check or the device check, the
anaesthesia workstation must not be attached to a patient under any
circumstances!
WARNING
Working with live components!
Risk of injury through electrocution.
▪Unplug the device from the mains before opening the housing.
▪Ensure it is not plugged in again without authorisation!
▪Before opening, remove all gas connections, including gas cylinders,
from the device.
WARNING

Chapter
3
Safety for you and the patient
Messages to the manufacturer and authorities
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19
Device malfunction!
Danger from EM interferences.
▪Avoid using this device in close proximity to other equipment or with
other equipment in a stack as this may result in improper operation. If
use in the manner described above is nevertheless necessary, this
device and the other devices should be observed to verify that they are
functioning properly.
▪The use of ACCESSORIES, transducers and wiring other than those
specified or provided by the MANUFACTURER of this equipment may
result in increased ELECTROMAGNETIC INTERFERENCES or
reduced electromagnetic immunity of the equipment and may result in
improper operation.
▪PORTABLE HF communications equipment (radios) (including their
ACCESSORIES such as antenna cables and external antennas) should
not be used within 30 cm (or 12 inches) of leon plus parts and wiring
designated by the MANUFACTURER. Failure to do so may reduce the
performance of the device.
WARNING
Flammable narcotic gases
Fire risk
Do not use any flammable anaesthetics!
Use only the following anaesthetics:
▪halothane
▪enflurane
▪isoflurane
▪sevoflurane
▪desflurane
WARNING
Lack of hygiene!
Risk of infection
▪Prepare the device and the hose system before first use.
▪Change the tube system after each patient or use a new ventilation
system filter (VSF) for each patient.
▪Use suitable ventilation system filters (VSF).
▪Do not use single-use products more than once.
WARNING
Messages to the manufacturer and authorities
All serious incidents related to the device must be
reported to the manufacturer and to the competent
authority of the Member State where the user is
established.

Chapter
3
Safety for you and the patient
Liability and guarantee
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Liability and guarantee
▪Liability for the functioning of the device transfers
in every instance to the owner or operator,
– if the device is maintained or commissioned
by persons who are not associated to
Löwenstein Medical or are not authorised by
Löwenstein Medical,
– if the device is handled in a way that does not
correspond to the intended use.
▪Löwenstein Medical is not liable for damage
arising from non-compliance with the above-
mentioned instructions.
▪Guarantee and liability provisions of the sale and
delivery conditions of Löwenstein Medical are
supplemented by the following instructions.
Combination with other devices Electrical coupling with devices that are not
mentioned in this user manual may only be carried
out after consultation with the manufacturers or an
expert.
Do not cover or place in an
unfavourable position
The device must not be covered or positioned in
such a way that its operation or functioning is
influenced negatively.
Alarms and troubleshooting ▪The anaesthesia workstation distinguishes
between three types of alarms: patient alarms,
system alarms and technical alarms.
▪The alarms are allocated, according to the
urgency of different priorities and are displayed in
the alarm window according to the level of
urgency (→ "Display of current alarms" p. 200).
▪The alarm limits for patient alarms can be set by
the user (→ "Setting patient alarm limits
manually" p. 207).
▪You have the option of seeing all of the alarms
that have appeared in the alarm log.
Cross-infections The following conditions ensure that the risk of cross-
infection is reduced to a tenable risk under normal
conditions and in the first fault instance:
▪Appropriate use (ventilation gas filter close to the
patient)
▪Design of the water trap
▪Return of the test gas before the CO2 absorber
▪Gas return filter into the patient part