Maintenance File of the SUPPORTAIR Rev A

CONTENTS

1. INTRODUCTION ... 3 1.1

WARNINGS / SAFETY RULES... 3

1.2

GUARANTEE / GUARANTEE SEAL ... 3

1.3

METHOD / TRACEABILITY / INSPECTION ... 3 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

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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 "SUPPORTAIR® 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 apparatus unless

the installation, maintenance or modifications are made by an authorised and trained person (in particular, training for the handling of products sensitive to electro-static discharges must include a section on the use of ESD protection devices and an explication of the symbol: ), 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.

1.3.1

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Maintenance File of the SUPPORTAIR ®

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.

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>> Chapter 3: Troubleshooting Assistance. >> Chapter 4: Inspection. >> Chapter 5: Corrective Maintenance. >> Chapter 6: Illustrated Catalog. >> Editions management page.

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Maintenance File of the SUPPORTAIR ®

Maintenance File

SUPPORTAIR ®

Chapter 1 – Technical and Functional Description (Rev. A)

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Maintenance File of the SUPPORTAIR ®

Maintenance File of the SUPPORTAIR ®

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CONTENTS

1. INTRODUCTION ...5 1.1

OVERVIEW ...5

2. TECHNICAL DESCRIPTION ...5 2.1

GENERAL TECHNICAL DATA FOR THE DEVICE...5

3. FUNCTIONAL DESCRIPTION...8 3.1

ARCHITECTURE - PRINCIPLE...8

3.2

OPERATION OF THE DEVICE ...9

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Maintenance File of the SUPPORTAIR ®

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1.

INTRODUCTION

1.1

OVERVIEW This chapter presents a brief reminder of the technical and functional characteristics of the SUPPORTAIR®.

2.

TECHNICAL DESCRIPTION The SUPPORTAIR® 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 SU1.1).

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. Tidal Volume : from 50 to 2000 ml (or cm3) absolute(1) >> Precision of measurement : ± 20 ml up to 200 ml and ± 10% above. Insufflation Pressure: from 4 to 60 mbar (or hPa) absolute(1) 1) 1) . >> Precision of measurement: ± (1.2 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 60 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 absolute setting >> Precision of calculation: ± 10%. FiO2 measurement: from 21% to 100% with cell COMEPA MI COM 102-1 (see § Accessories and options) 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.

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Maintenance File of the SUPPORTAIR ®

Note : The FiO2 rate measurement is influenced by pressure variations. Calibration of the FiO2 sensor, which is carried out automatically at every ventilation start-up, should be repeated regularly in case of significant pressure condition variations (± 10 mbar) applied by the ventilator (see § Oxygen Supply). Measurement of SpO2: from 80% to 100% with ENVITEC MI-SP 3012 finger tip clip compatible with NONIN (see § Accessories and options) >> Measuring accuracy: ± 2% with fingertip clip Inspiratory resistance of the ventilator: 2 mbar to 60 l/min.

Exhalation resistance of the ventilator (for double branch option): 0,4 mbar at 60 l/min (without exhalation valve) Internal volume of ventilator: 244 cm3 Exhalation block volume: 14 cm3 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 ± 1.5 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.

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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 c/min Vt ≈ 300 ml IPAP ≈ 20 mbar R ≈ 15 c/min Vt ≈ 500 ml IPAP ≈ 30 mbar R ≈ 15 c/min

10 h

Max of ventilation parameters

8h 6h 4h

The time taken to recharge the internal batteries is of the order of 8 hours to obtain a good level of autonomy. It is recommended to allow the apparatus to recharge for 12 h when recharging takes place during use of the apparatus. A front face indicator continuously displays the state of charge of the internal battery (see § Battery maintenance). Note: Recharging the internal battery may sometimes be incomplete, regardless of the charge time, if the ambient temperature is above 35°C. 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, P = 335 mm. Weight: 4,9 kg (excluding accessories, wiring and external tube). 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.

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Maintenance File of the SUPPORTAIR ®

Note: The flow rate measurements and thus the volume calculations that result are influenced by variations in atmospheric pressure. A calibration of the flow sensor is recommended if there is a significant difference from 1000 hPa atmospheric pressure (see paragraph on Sensor Calibration). For example, altimetric variation of 1000 m leads to a variation of flow rate measurement of the order of 10%. Under extreme conditions of use beyond the recommendations above but within the limits of a temperature of 50°C or a humidity of 95% HR or an atmospheric pressure of 600 or 1100 hPa or a supply voltage of –20% compared to nominal or the combination of a temperature of 45°C and humidity of 75% HR, the ventilator does not demonstrate particular malfunction nor danger for the user. However, the battery cannot be recharged if the ambient temperature is greater than 35°C. Operating the device for many hours repeatedly under such extreme conditions could involve a premature ageing of components hence calling for more frequent maintenance.

3.

FUNCTIONAL DESCRIPTION

3.1

ARCHITECTURE - PRINCIPLE The SUPPORTAIR® 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, fan) − Battery block − Pneumatic block (flow laminator + solenoid valve+ O2 supply + O2 block, Expiration block (Option) + couplings + silicon and polyurethane tubes) − CPU block (piloting printed circuit board + turbine control board) − Structure and User-Machine Interfaces (housings + display + keypad + communication ports)

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3.2

OPERATION OF THE DEVICE The operation of the device is based on a self-adapting drive system in a closed loop of the speed of the flow generator. The speed of the flow generator (turbine) is servocontrolled to the patient pressure signal or the inhaled flow signal. The laws for piloting turbine speed are based on equations and vary according to the ventilation modes, settings and the respiratory 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 exhalation phase is itself controlled by a deceleration or braking proportional to the difference in pressure between the two phases. The exhalation valve is itself pressure-piloted during the inhalation phase and as the main regulation part during the exhalation phase. The speed of the turbine is thus adapted to the exhalation pressure threshold during the entire exhalation 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 exhalation brake phenomenon without however cancelling it in order to prevent turbine overheating and expired gasses re-aspiration phenomena. There is no piloting valve for operating modes without an exhalation valve, since its actuator remains open in the rest position. The pressure is regulated by piloting the turbine in both the insufflation and exhalation phases. Rinsing is then more thorough in the exhalation phase during which the pressure cannot be cancelled. The measurement of the flow rate completes the system by enabling detection of patient inhalation 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 oxygen dosage system, however, is piloted on the basis of measurements of the oxygen and output airflow from the turbine block. The air is mixed with the oxygen in the turbine block. The overall safety of the function is ensured by monitoring the oxygen pressure level.

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Maintenance File of the SUPPORTAIR ®

110 / 220 V AC 50 / 60 Hz Input

Partial ON/OFF switch

O2 Input 280 to 600 kPa ( EN 737-1)

Turbine box + Sound insulation Air inlet

or 24 V DC

AC/DC power supply + Battery charger

Battery 25.2 V 4.4 Ah

Power supply switchover

O2 Regulator Block Piezzo valve 2 ways

O2 Flow sensor

Turbine control board

Air filters

Turbine

Cooling fan O2 Pressure sensor

Piezzo valve 3 ways

Flow sensor

Serial port

Laminator

Pressure sensor

CPU Board FiO2 Socket

Pressure sensor

Display

Keyboard Flow sensor

Buzzer Board

Pressure sensor

Alarm Repeater

SpO2 Board

SpO2 Socket

Laminator Casings Patient

Patient pressure socket

Exhalation valve command

To the patient

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Lastly, the internal temperatures of the battery and electronic environment are allowed for in piloting the cooling ventilator so as to maintain thermal conditions compatible with the levels acceptable by the various components and ensure satisfactory service endurance. The various measurement signals used in the piloting and detection are specifically filtered in order to limit risk of disturbance and malfunction.

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Maintenance File

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Chapter 2 – Preventive Maintenance (Rev. A)

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CONTENTS 1. INTRODUCTION...5 1.1

OVERVIEW ... 5

1.2

DEFINITION OF MAINTENANCE PROCEDURES ... 5 1.2.1 Preventive operations summary table... 6

1.3

CORRESPONDENCE TABLE ... 7 1.3.1 Correspondence table in months of use ... 7 1.3.2

Correspondence table in hours of use (intensive use)... 7

1.4

SAFETY MEASURES ... 8

1.5

TIGHTENING TORQUE / TOOLS / FASTENERS ... 9 1.5.1 Tightening torque ... 9 1.5.2

Removal – installation tools ... 9

1.5.3

Fasteners ... 9

2. MAINTENANCE INSPECTION V1 (OR 1500 H) ...11 2.1

CLEANING AND DISINFECTION (FIG CP 2.1)... 11 2.1.1 Cleaning the device... 11 2.1.2

Patient circuit... 11

2.2

CLEANING THE EXHALATION BLOCK (FIG CP 2.2) ... 13 2.2.1 Removal / Cleaning / Installation... 13

2.3

REMOVAL / INSTALLATION OF THE FINE PARTICLE FILTER (FIG CP 2.3) ... 15 2.3.1 Removal / Installation ... 15

3. MAINTENANCE INSPECTION V2 (OR 3000 H) ...17 3.1 CHECKING USER-MACHINE INTERFACES, VOLTAGES AND SENSORS (FIG CP 2.4A/ 2.4B/ 2.4C) 17 3.1.1 Checking user/machine interfaces ... 17 3.1.2

Checking the sensors... 20

3.1.3

Checking the measurements ... 25

3.1.4

Checking the battery temperature... 28

3.1.5

Checking the buzzers... 28

3.1.6

Checking software version ... 28

4. MAINTENANCE INSPECTION V3 (OR 4500 H) ...30 4.1

OPENING AND CLOSING THE DEVICE – RELATED PROCEDURE (FIG CP 2.5) ... 30 4.1.1 Opening and closing... 30

4.2

REMOVAL / INSTALLATION OF THE BATTERY (FIG CP 2.6) ... 34 4.2.1 Removal / Installation ... 34

4.3

FLOW LAMINATOR CLEANING PROCEDURE (FIG CP 2.7) ... 36 4.3.1 Removal / Cleaning / Installation... 36

4.4

CHECKING, ADJUSTMENT AND CALIBRATION 02 (FIG CP 2.8)... 38 4.4.1 Checking the O2 flow ... 38 4.4.2

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O2 flow calibration... 41

REMOVAL / INSTALLATION OF FITTED I/O PILOT SOLENOID VALVE (FIG CP 2.12) ... 43 Maintenance File of the SUPPORTAIR ®

4.5.1

Removal / Installation... 43

5. MAINTENANCE INSPECTION V4 (OR 15000 H)... 45 5.1

REMOVAL / INSTALLATION OF COMPLETE O2 BLOCK (FIG CP 2.9)... 45 5.1.1 Removal / Installation... 45

5.2

REMOVAL / INSTALLATION OF THE EQUIPED TURBINE BOX (FIG CP 2.10) ... 47 5.2.1 Removal / Installation... 47

5.3

REMOVAL / INSTALLATION OF THE FAN (FIG CP 2.11) ... 51 5.3.1 Removal / Installation... 51

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