West Care Legendair User manual

Legendair
Service Manual
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CH0-1Maintenance File of the
LEGENDAIR
®
Maintenance File
LEGENDAIR ®
Chapter 0 – Introduction to Maintenance (Rev. B)

Maintenance File of the LEGENDAIR
®CH0-2
CONTENTS
1. INTRODUCTION ..........................................................................................................................3
1.1 WARNINGS / SAFETY RULES.........................................................................................................3
1.2 GUARANTEE / GUARANTEE SEAL ................................................................................................ 3
1.3 METHOD/TRACEABILITY/CONTROL
1.3.1 Traceability............................................................................................................................ 4
1.3.2 Inspection sheet (appendix 1 – Chap IV).............................................................................. 4
2. DEFINITION OF CHAPTERS.......................................................................................................4
2.1 DOCUMENTATION PLAN:............................................................................................................... 4

CH0-3Maintenance File of the LEGENDAIR
®
1. INTRODUCTION
1.1 WARNINGS / SAFETY RULES
This maintenance file was produced within a limited context. Only persons trained and
approved by AIROX are authorized to use it.
The person (operator) who needs to do any work on defective elements must refer to
the electrical safety rules in force for this type of work. Similarly, knowledge about how
this type of device is used is desirable (Refer to the " LEGENDAIR
®
User's Manual" if
necessary).
BEFORE DOING ANY MAINTENANCE WORK, MAKE SURE THAT THE DEVICE IS
SWITCHED OFF.
>> AIROX cannot be held responsible for incidents caused by this device unless the
installation, maintenance or modifications are made by an authorized person using
original spare parts and respecting quality assurance and traceability rules
approved by AIROX. Due to its CE marking, no modifications may be made
without the written permission of AIROX.
1.2 GUARANTEE / GUARANTEE SEAL
>> No maintenance work for which the equipment needs to be opened is necessary
within the first twelve months of operation.
A tamper proof label under the equipment states that the equipment is under
"Guarantee" for the first year.
The contractual guarantee provided by AIROX will be null and void if this label is
damaged in any way by opening the equipment during the first twelve months (unless
AIROX gave written permission before the equipment was opened).
1.3 METHOD / TRACEABILITY / INSPECTION
The operator should note all equipment configuration parameters before starting to do
any work, if possible depending on the operating condition.

Maintenance File of the LEGENDAIR
®CH0-4
1.3.1 Traceability
It is recommended that approved After Sales services should keep the following
elements for 10 years, for traceability purposes:
−work data,
−inspection sheet.
If there is an incident with a device, these documents will be requested to determine its
history and to demonstrate that maintenance and the work operations have actually
been done.
In general, the operator should record information about the work - Nature of the work,
replacement of defective parts.
1.3.2 Inspection sheet (appendix 1 – Chap IV).
Adjustment-inspection instructions must be applied in all cases after each mechanical
and/or electrical operation. Do not forget to reconfigure the device in accordance with
the user's parameters (Elements backed up before the work operation).
2. DEFINITION OF CHAPTERS
This file is organized in the form of chapters to define all information necessary for the
maintenance technician.
2.1 DOCUMENTATION PLAN:
>> Cover page.
>> Chapter 0: Introduction to Maintenance.
>> Chapter 1: Technical and Functional Description.
>> Chapter 2: Preventive Maintenance.

CH0-5Maintenance File of the LEGENDAIR
®
>> Chapter 3: Troubleshooting Assistance.
>> Chapter 4: Inspection.
>> Chapter 5: Corrective Maintenance.
>> Chapter 6: Illustrated catalog.
>> Editions management page.

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CH1-1 Maintenance File of the
LEGENDAIR
®
Maintenance File
LEGENDAIR ®
Chapter 1 – Technical and Functional Description (Rev. B)

Maintenance File of the LEGENDAIR
®CH1-2

CH1-3 Maintenance File of the LEGENDAIR
®
CONTENTS
1. INTRODUCTION...........................................................................................................................5
1.1 OVERVIEW........................................................................................................................................5
2. TECHNICAL DESCRIPTION........................................................................................................5
2.1 GENERAL TECHNICAL DATA FOR THE DEVICE...........................................................................5
3. FUNCTIONAL DESCRIPTION......................................................................................................7
3.1 ARCHITECTURE - PRINCIPLE.........................................................................................................7
3.2 OPERATION OF THE DEVICE .........................................................................................................8

Maintenance File of the LEGENDAIR
®CH1-4

CH1-5 Maintenance File of the LEGENDAIR
®
1. INTRODUCTION
1.1 OVERVIEW
This chapter presents a brief reminder of the technical and functional characteristics of
the LEGENDAIR
®
.
2. TECHNICAL DESCRIPTION
The LEGENDAIR
®
is composed of elements located in two sub-assemblies forming
the top casing and the bottom casing of the nose ventilator.
These two equipped sub-assemblies also incorporate wiring and an air circuit (see the
air path – fig LE1.1).
2.1 GENERAL TECHNICAL DATA FOR THE DEVICE
Insufflation Flow Rate: from 0 to 200 l/min (or dm3/min) in absolute.
>> Maximum flow rate at 10 mbar = 190 l/min,
>> Maximum flow rate at 20 mbar = 160 l/min,
>> Precision of measurement: ± 10% above 15 L/min.
Insufflation Pressure: from 4 to 55 mbar (or hPa) absolute(1) .
>> Precision of measurement: ± (0.8 mbar + 4% of reading).
Note : The maximum pressure limit threshold above which the device cannot supply a flow of air
(intrinsic limitation of the turbine motor) is 70 mbar.
Cycling rate: from 4 to 40 bpm (or breaths/min) absolute.
>> Precision of calculation: ± 1 bpm.
I/T cycling mode: from 25% to 50% in absolute setting.
>> Precision of calculation: ± 10%.
I/E cycling mode: from 1/1 to 1/3 in absolutesetting
>> Precision of calculation: ± 10%.
FiO2 measurement: from 18% to 100% with cell COMEPA MI COM 102-1 to 1013
hPa and 25°C
>> Precision of measurement: ± 3%
>> Response time: < 13 s for 90% of the final value
>> Stability of the precision of measurement: ± 1% past 8 h
(1) There are specific limitations for each mode.

Maintenance File of the LEGENDAIR
®CH1-6
Inspiratory resistance of the ventilator: - 3 mbar to 60 L/min.
Level of sound pressure in accordance with standard NF EN ISO 17510-1: 30 dBA
A/C Electrical supply:
−115/230 V ± 10% - 50/60 Hz.
−Consumption: 80 VA nominal and 90 VA max.
DC direct electrical power supply:
−24 V ± 2.5 V -3.3 A maxi
−Consumption: 80 VA nominal
Internal battery: 25.2 V -4.4 Ah of the Lithium Ion - rapid recharge type.
The autonomy offered by the internal battery depends on the level of adjustments
made, the environmental conditions (primarily in terms of temperature) as well as the
physiological characteristics of the patient.
On average autonomy with a temperature of 25°C is as follows:
Ventilation parameters Average autonomy based on
maximum battery charge
VT ˜ 200 ml
IPAP ˜ 10 mbar
R ˜ 20 bpm 10 h
VT ˜ 300 ml
IPAP ˜ 20 mbar
R ˜ 15 bpm 8 h
VT ˜ 500 ml
IPAP ˜ 30 mbar
R ˜ 15 bpm 6 h
Max of ventilation
parameters 4 h
The time taken to recharge the internal batteries is of the order of 8 hours to obtain a
good level of autonomy (see § Battery maintenance).
Insulation class: Class II – Protection index IP 30.
Medical device class: Class II B – Type BF applied part.
Dimensions (excluding accessories) : H = 154 mm, L = 235 mm, D = 315 mm.
Weight: 4.5 kg in double branch option.

CH1-7 Maintenance File of the LEGENDAIR
®
The following environmental conditions shall be respected:
In storage or transport:
−Temperature: -20 to 60 °C.
−Humidity: 10 to 80 % RH.
−Atmospheric pressure: 600 to 1060 hPa.
In use:
−Temperature: 5 to 35 °C.
−Humidity: 30 to 75 % RH.
−Atmospheric pressure: 700 to 1060 hPa.
Note: The measurements of the flow rates and therefore the estimations of volume of
leakage that result (see § Measurement visualisation) are influenced by the variations
in atmospheric pressure. A calibration of the flow rate sensor is recommended if
atmospheric pressure is much different than 1000 hPa (see § Sensor calibration). For
example, altimetric variation of 1000 m leads to a variation of flow rate measurement of
the order of 10%.
In extreme conditions of use (such as humidity at 95% and power supply at -15%) the
ventilator does not demonstrate particular malfunction.
3. FUNCTIONAL DESCRIPTION
3.1 ARCHITECTURE - PRINCIPLE
The LEGENDAIR
®
ventilator is composed of an airflow generator to manage the
inspiration and expiration phases controlled by variable set values.
The overall system is controlled by a computer that receives information from pressure
and flow sensors.
The flow generator is a micro-turbine driven by an electric motor.
The main function blocks are as follows:
−Generator block (Turbine built into a box with sound insulation and air
filter)
−Supply block / Charger (AC/DC power supply, wiring, switching board)
−Battery block
−Pneumatic block (flow laminator + solenoid valve+ O2 supply + Expiration
block (Option) + couplings + silicon and polyurethane tubes)

Maintenance File of the LEGENDAIR
®CH1-8
−CPU block (piloting printed circuit board + turbine control board)
−Structure and User-Machine Interfaces (housings + display + keypad +
communication ports)
3.2 OPERATION OF THE DEVICE
The LEGENDAIR
®
ventilator is composed on one hand of an airflow generator
capable of supplying a sufficient range of flow rates and pressures and on the other
hand of a three-way valve enabling piloting of the expiration valve.
The flow generator is a low-inertia micro-turbine driven by a brushless electric motor:
the valve is a proportional piezo valve.
These two actuators are controlled according to specific piloting laws by a computer
receiving information from the pressure and flow sensors built into the apparatus.
The operation of the device is based on a self-adapting drive system of the speed of
the flow generator, in a closed loop.
The speed of the flow generator (turbine) is servo-controlled to the patient pressure
signal or the inspired flow signal.
The laws for piloting turbine speed are based on equations and vary according to the
ventilation modes, settings and the ventilatory cycle phases. Thus, fixing the pressure
flow ramp or flow rise time has an influence on the level of turbine acceleration at the
start of insufflation. The transition between the insufflation and expiration phase is itself
controlled by a deceleration or braking proportional to the difference in pressure
between the two phases.
The expiration valve is pressure-piloted during the inspiratory phase and as the main
regulation part during the expiratory phase. The speed of the turbine is thus adapted to
the expiratory pressure level during the entire expiratory phase in order to compensate
for "parasite" leaks in the circuit beyond the leak regulated by the valve. This rinsing
flow is as small as possible in order to limit the patient expiratory brake phenomenon
without however cancelling it in order to prevent turbine overheating and expired
gasses re-aspiration phenomena. A system of non-return valve and spontaneous
ventilation are used to facilitate the threshold of balance.

CH1-9 Maintenance File of the LEGENDAIR
®
Laminator
Input 110 / 220 V AC
50 / 60 Hz
or DC 24 V
CPU board
Series
port
Air filter
Display
Keypad
Turbine
Turbine casing+
sound insulation
Partial ON/OFF
switch
Toward patient
Housing
Battery
25.2 V
4.4 Ah
Air inlet
Inlet O2
Expiration
Command
Valve
Switching board
A
Ctrl Turbine board
Reminder
Alarm
Pressure
sensor
Pressure
sensor
From patient
Socket
FiO2 Solenoid
valve Valve Block
Laminator
Flow
sensor

Maintenance File of the LEGENDAIR
®CH1-10
The measurement of the flow rate completes the system by enabling detection of
patient inspiratory efforts and to trigger insufflation phases. The flow rate measurement
can also be used to determine the end of the insufflation phase in certain ventilation
modes. Finally, it serves to calculate the leak volumes and rates reached at each
cycle, regardless of the ventilation mode in progress. This also enables the proposal of
an automatic adjustment of the insufflation pressure between two determined limits in
order to attain a desired volume.
The various measurement signals used in the piloting and detection are specifically
filtered in order to limit risk of disturbance and malfunction.

CH1-11 Maintenance File of the LEGENDAIR
®

Parc d’activités Pau-Pyrénées
ZI de l’échangeur
64008 PAU CEDEX (FRANCE)
Tel. [phone]- Fax : [phone] - E-mail : [email protected]