Supportair Ventilator Operators Manual May 2006

SUPPORTAIR® User’s Manual

INSTALLATION ... 101 SpO2 MEASUREMENT AND USE ... 102 MAINTENANCE ... 103 MAINTENANCE MENU ... 103 Technical defaults alarms memory ... 103 Verification of internal electrical supplies... 104 Calibrating the sensors... 106 Turbine test ... 109 PREVENTIVE MAINTENANCE ... 110 Consumables and change frequencies ... 110 Maintenance of exhalation block ... 110 Internal Battery Maintenance... 111 Cleaning and disinfecting ... 113 RESOLUTION OF INCIDENTS ... 115 ACCESSORIES AND OPTIONS ... 122 FIO2 MEASUREMENT KIT– Code 3814100... 122 O2 PULSE OXYMETRY SENSOR – Code 5092300 ... 124 ALARM REPEATER – Code 4096000 ... 124 TROLLEY – Code 4096400 ... 125 WARMING HUMIDIFIER – Code 4090000 ... 125 24V ELECTRICAL SUPPLY CORD – Code 3810800 ... 126 SINGLE USE, SINGLE CONNECTION PATIENT CIRCUIT- Code 5092100 ... 126 SINGLE USE, DOUBLE CONNECTION PATIENT CIRCUIT - Code 5092200.. 126 AIROX COMMUNICATION SOFTWARE – Code 2962000 ... 127 COMMUNICATION CORD – Code 2961900 ... 127 O2 SUPPLY TUBE – Code 2739200 ... 128 AFTER SALES SERVICE... 129 WARRANTY TERMS... 130

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SUPPORTAIR® User’s Manual

GENERAL PRECAUTIONS FOR USE It is essential to read, understand and follow these instructions before using the SUPPORTAIR® ventilator. The SUPPORTAIR® ventilator was designed according to standards of pulmonary ventilators intended for hospital use. This ventilator is recommended for Non-Invasive Ventilation (NIV) as well as Invasive Ventilation (VI) in temporary or continual use for adult patients or for paediatrics (children over 5 kg). For patients without breathing autonomy or who are totally dependent, supplementary surveillance is recommended according to the patient's handicap. The standard EN 794-1 recommends moreover having a means of backup ventilation in this case. In order to use the apparatus correctly and efficiently and in order to prevent incidents, bear the following points in mind: •

The SUPPORTAIR® ventilator must be used only under the responsibility and on the prescription of a doctor.

•

The SUPPORTAIR® ventilator must not be used with inflammable anaesthetic substances.

•

The SUPPORTAIR® ventilator must not be used for transport outside the hospital precincts, whatever the means of transport.

•

The apparatus must not be connected to anti-static tubes or conduits or electric conductors.

•

The operation of the SUPPORTAIR® ventilator may be disrupted by electromagnetic interference. It needs to be installed and then started according to the recommendations in the installation guide. In particular the use of nearby mobile and portable communications equipment using radio frequencies such as mobile telephones or other systems exceeding the levels set in the CEI 60601-1-2 standard may affect its operation.

•

The SUPPORTAIR® must not be used near other equipment or stacked with other equipment other than those indicated in the user guide distributed by AIROX. If this type of location is necessary, the normal operation of the equipment must be verified under the final conditions of use.

•

The RS232 series communications port is sensitive to electro-static discharges: . It must only be handled after the usage precautions for this type of product have been made (earth the operator with an anti-static bracelet).

•

The electrical supply to which the SUPPORTAIR® ventilator will be connected and which will provide its required power must comply with the standards in force. In the case of the use of a D.C. 24 V external power, this shall be in conformity with directive 93/42/EEC.

•

All electrical cables that can be connected to the apparatus (electrical power supply, sensor signals, digital communication) shall observe recommendations on length and protection fixed in the present document. I - 4 - 00

SUPPORTAIR® User’s Manual

•

The use of any accessory other than those specified, with the exception of the power supplies or cables sold by AIROX when replacing internal components, may lead to an increase in electro-magnetic emissions or a decrease in the equipment’s insulation against electro-magnetic emissions.

•

To ensure correct performance of the SUPPORTAIR® ventilator, the connections of the outlet towards the patient and the return to the exhalation block must be made with tube of 1.10 m to 2.00 m length between ventilator and patient, tube must conform to standard EN 12342 and be fitted with Ø 22 mm terminals conforming to standard EN 1281-1. Precaution must be taken to ensure that the length and the internal volume of the patient circuit are well adapted to the tidal volume: ringed tube Ø 22 mm for adults and ringed tube Ø 15 mm for paediatrics with tidal volume lower than 200 ml.

•

The inspiration resistance level of circuits and accessories that may be added on (anti-bacterial filter, humidifier) must not exceed 2 mbar at 60 l/m. They are taken into account by the apparatus to obtain pressure levels only when the proximal pressure level is connected downstream from these accessories. If the proximal pressure is not used, the settings must be made as appropriate to the circuit installation requirements.

•

This apparatus can be used either with a mask with a calibrated exhalation orifice or associated to a leakage device ensuring exhalation of the patient, or with a leak proof mask, a tracheotomy canula, an intubation’s probe when the circuit is equipped with an exhalation valve connected to the apparatus. Use of the proximal pressure tube is mandatory in the case of ventilation with an exhalation valve.

•

The piloted exhalation valve must not present any resistance to exhalation and must ensure rapid discharge of the circuit.

•

For all ventilation modes using an inspiration trigger threshold, attention must be drawn to the possible risk of hyperventilation if the patient makes abusive use.

•

In the case of oxygen supply, it must be noted that oxygen therapy for patients with respiratory failure is a well thought-out medical prescription. Too high an oxygen flow is likely to lead to serious complications such as decreased minute ventilation due to change in the peripheral and central regulation processes of ventilation, and the increase in anomalies in ventilation/perfusion ratios due to modifications of the regulation of pulmonary perfusion. Accordingly, it is recommended to monitor directly the FiO2 value.

•

The SUPPORTAIR® requires special precautions for electro-magnetic compatibility and needs to be installed then started according to the recommendations in the user's manual:

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SUPPORTAIR® User’s Manual

Electro-magnetic emissions The SUPPORTAIR® is designed to be used in the electro-magnetic environment specified below. The equipment’s customer or user must ensure that it is being properly used in this environment.

Emission test

Conformity

Recommended electro-magnetic environment

RF emissions CISPR 11

Group 1

The SUPPORTAIR® only uses RF energy for its internal operations. Therefore its RF emissions are very weak and cannot be assumed to interfere with nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Transient emissions / Voltage fluctuation IEC 61000-3-3

Compliant

The SUPPORTAIR® may be installed in any establishment including domestic establishments and those directly connected to the public networks supplying domestic buildings.

Electro-magnetic immunity Immunity test

Electro-static discharge (ESD) IEC 61000-4-2

Transient electrical impulses in bursts CEI 61000-4-4

Lightening CEI 61000-4-5

Dips, cuts and voltage variations in the electrical power supply IEC 61000-4-11 Note: Opposite UT is the voltage sector before applying the test level.

Magnetic fields in the Power Supply Frequencies (50/60 Hz) IEC 61000-4-8

Test level IEC 60601

Level of conformity

± 6 kV on contact

± 6 kV on contact

± 8 kV in the air

± 8 kV in the air

± 2 kV on power lines

± 2 kV on power lines

± 1 kV on inputs / outputs

± 1 kV on inputs / outputs

± 1 kV in differential mode

± 1 kV in differential mode

± 1 kV in common mode

± 2 kV in common mode

< 5% UT (>95% dip in UT) for 0.5 cycles

< 5% UT (>95% dip in UT) for 0.5 cycles

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

< 5% UT (>95% dip in UT) for 5 s

< 5% UT (>95% dip in UT) for 5 s

3 A/m

3.4 A/m

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Recommended electro-magnetic environment The floor must be wood, concrete or ceramic. If the floor is covered with a synthetic material, humidity must be at least 30%. The quality of the power supply sector must be equivalent to a commercial or hospital environment. The quality of the power supply sector must equivalent to a commercial or hospital environment.

The quality of the power supply sector must equivalent to a commercial or hospital environment. If the SUPPORTAIR® user requires it to continuously operate during interruptions in power supply, it is recommended that SUPPORTAIR® be connected to a noninterruptible power supply or to a battery.

Magnetic fields in the Power Supply Frequencies must be at levels similar to a commercial or hospital environment.

SUPPORTAIR® User’s Manual

Electro-magnetic immunity (follows) The SUPPORTAIR® is designed to be used in the electro-magnetic environment specified below. The equipment’s customer or user must ensure that it is being properly used in this environment.

Immunity test

Conducted Radio frequency IEC 61000-4-6

Test level IEC 60601

3 V rms 150 kHz to 80 MHz (a) outside ISM bands

10 V rms 150 kHz to 80 MHz (a within ISM bands

Level of conformity

3V

3V

Recommended electro-magnetic environment Portable RF communications equipment must not be used near the SUPPORTAIR® or its connecting cables. The distance « d » of separation to be kept expressed in metres (m) in terms of the maximum power « P » in Watts (W) of the emitter according to the manufacturer’s data and according to the (b) frequency of the same emitter is : d = 1.2√P from 150 kHz to 80 MHz outside ISM bands d = 4√P from 150 kHz to 80 MHz within ISM bands d = 1.2√P from 80 MHz to 800 MHz d = 2.3√P from 800 MHz to 2.5 GHz

Radiated Radio frequency IEC 61000-4-3

10 V/m 80 MHz to 1 GHz

10 V/m

The power of the magnetic field emitted by a fixed RF emitter, as determined by (c) the electro-magnetic surveillance site , must be below the level of conformity for (d) each frequency interval.

Electro-magnetic interference may occur near to equipment with the symbol:

NOTE 1: At 80 MHz and 800 MHz, the highest frequency interval is applied NOTE 2: This guide is not applicable in every situation. The issue of electro-magnetic waves is affected by the absorption and the reflection of structures, objects and people. (a)

The ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 to 40.70 MHz.

(b)

Conformity levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are supposed to reduce the probability that mobile/portable communication equipment cause interference if they are unknowingly placed near to a patient. This is why an additional 10/3 factor is used in calculating the distance of separation for emitters with this frequency range. (c)

Force fields from fixed emitters, such as cordless telephone bases, mobile radios, CB radios, AM and FM radio emissions, TV emissions may not be accurately predicted in theory. In order to evaluate the electro-magnetic environment from fixed emitters, an electro-magnetic surveillance site must be considered. If the force field measured in the environment where the SUPPORTAIR® has to be used, exceeds the above applicable RF levels, the SUPPORTAIR® must be watched to check if it is working normally. If abnormal performance is observed, extra measures have to be taken such as redirecting or moving the SUPPORTAIR®.

(d)

Above the 150 kHz to 80 MHz frequency range, force fields must be less than 3 V/m.

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SUPPORTAIR® User’s Manual

Recommended distance between portable and mobile RF communications equipment and the SUPPORTAIR® The SUPPORTAIR® is designed to be used in an environment where RF disturbances are controlled. The SUPPORTAIR® customer or user may prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the SUPPORTAIR® as specified below in accordance with the maximum power of the communications equipment. Distance apart in terms of the emitter’s frequency (m)

Maximum power of the emitter (W)

150 kHz to 80 MHz outside the ISM bands

150 kHz to 80 MHz within the ISM bands

d = 1.2√P

d = 4√P

0.01

0.12

0.1

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2√P

d = 2.3√P

0.40

0.12

0.23

0.38

1.3

0.38

0.73

1

1.2

4

1.2

2.3

10

3.8

12

3.8

7.3

100

12

40

12

23

For checked emitters with a maximum power not listed above, the recommended separation distance « d » in meters (m) may be determined using the equation applicable to the emitter’s frequency, where « P » is the maximum power of the emitter in Watts (W) according to the emitter’s manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance of the highest frequency range is applied. NOTE 2: ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 to 40.70 MHz. NOTE 3: Another 10/3 factor is used in calculating the separation distance for emitters in the 150 kHz and 80 MHz ISM range as well as the frequency range between 80 MHz and 2.5 GHz in order to reduce the probability that mobile/portable communication equipment causes interference if they are unknowingly taken near the patient. NOTE 4: This guide is not applicable in every situation. The issue of electro-magnetic waves is affected by the absorption and the reflection of structures, objects and people.

•

This apparatus is relatively fragile; laying objects on it during use and storage or letting it function a long time with a direct exposure in the sunlight are not recommended.

•

With a view to protection of the environment, the SUPPORTAIR® ventilator and its constituent elements, regardless of their respective operating condition, must never be discarded with household waste and must absolutely be integrated into an appropriate selective collecting system for possible recycling in accordance with Directive 2002/96/CE concerning Electrical and Electronic Equipment Waste:

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SUPPORTAIR® User’s Manual

QUALIFICATION OF PERSONNEL 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. COMPLIANCE The SUPPORTAIR® ventilator complies with the specifications of current standards: •

NF C 74-011 / EN 60 601-1 / IEC 601-1 (1996) Electro-medical apparatus – General safety regulations

•

IEC 60601-1-2 (2001) Collateral Standard: Electromagnetic compatibility – Directions and tests

•

IEC 601-1-4 (1999) Collateral Standard: Safety regulations for programmable electronic medical systems

The compliance of the SUPPORTAIR® ventilator to the IEC 601-1-4 standard warranties the software mastery and minimizes the risks that it could induce. •

NF S 99-211 / ISO 14971 (2003) Application of risk management to medical devices

•

NF C 20-010 / EN 60 529 (2000) Degree of protection produced by envelopes (IP code)

•

NF S 95-118 / EN 794-1 (2001) Pulmonary Ventilators – Regulations for critical uses

The CE marking certificate shown below attests to apparatus approval: Note: This certificate corresponds to the range of AIROX products under CE marking at the date of launching the device described in this manual. To obtain the last statement of the certificate please contact AIROX.

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SUPPORTAIR® User’s Manual

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SUPPORTAIR® User’s Manual

SYMBOLS USED It is essential to read and understand the User's Manual and to comply with the instructions before using the apparatus. BF type of Apparatus (applied part) Direct current (DC) Alternating current (AC) Internal battery – Load indicator Insulation class II Movement of cursor upwards / Incrementation of parameters Curves released Movement of cursor downwards / Decrementation of parameters Curves “frozen” Validation of command actions Inhibition and/or manual cancellation of alarms. Page scrolling 100% O2 forced for 2 minutes Starting – Stop of ventilation Air outlet towards patient Air return from patient (double branch option) Patient proximal pressure socket Piloting of the exhalation valve FiO2 external connecting cell. Oxygen inlet SpO2 pulse oxymetry sensor connection External alarm repeater connection I - 11 - 00

SUPPORTAIR® User’s Manual

Serial link

0

Switch in "Off" position

l

Switch in "On" position Locking key Indicator that internal battery is in use and is discharged Indicator that exhalation valve is present / absent Indicator that curves are “frozen” Pressure rise times Flow ramps

■ ♦

Shows cursor position when not locked

▲

icon indicating preferred setting

-

Setting line (not accessible when lock applied)

±

Shows parameter setting action

●

Indicator of inspiration effort detection Observe the precautions necessary when handling a device subject to the damage of electrostatic discharge Product not discardable with household waste, to be covered by selective collection for recycling

COMMON ABBREVIATIONS USED •

Pressures:

IPAP

: Inspiration pressure

EPAP

: Positive exhalation pressure

Cpap

: Continuous positive pressure

Maxi P / Pi maxi: Maximum inspiratory pressure or High pressure Pi mini

: Minimum inspiratory pressure or Low pressure I - 12 - 00

SUPPORTAIR® User’s Manual

•

Volumes and Flows:

Vt

: Tidal Volume delivered on each cycle

Vti

: Tidal volume inspired

Vte

: Tidal volume exhaled

Target Vt

: Ventilation volume objective

•

Rates:

R

: Rate or Number of respiratory cycles per minute

Mini R

: Rate or Number of minimum cycles per minute

Back Up R : Rate or Number of cycles to be provided in case of apnea R SIMV •

: Rate or period between the SIMV volume cycles

Time:

I/T

: Ratio in % between insufflation time and the total time of one cycle

I/E

: Auto-descriptive ratio of the insufflation time to the exhalation time

Ti

: Time or duration of insufflation

Te

: Time or duration of exhalation

Tt

: Total time or duration of one cycle

Apnea : Apnea time or duration without patient inspiration •

Miscellaneous:

Flow Ramp : Shape of flow during inspiration. Rise Time

: Shape or duration of pressure rise at the beginning of inspiration

Trigg I : Inspiration trigger threshold – Indicates the inspiration effort that the patient must exert to trigger a spontaneous inspiration cycle Trigg E : Exhalation Trigger – Percentage ratio between the drop in inspiration flow and the maximal peak flow. Sigh

: Sigh volume and rate – Periodic increase of volume by modification of inspiration time.

FiO2

: Oxygen fraction inspired.

SpO2 : O2 saturation measured by pulse oxymetry.

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SUPPORTAIR® User’s Manual

TECHNICAL CHARACTERISTICS

SUPPORTAIR® is a dual ventilator of the « continuous service» type ensuring: -

invasive or non invasive ventilation,

-

an exhalation valve or calibrated leakage,

-

volume or barometric pressure ventilation,

-

ventilation equally well of adults and children.

For use in paediatrics, the user should check that the settings of the normal volume and the type of patient circuit are indeed appropriate to the needs of the child. -

use of a single-branch patient circuit with or without Exhalation valve or double branch with Exhalation valve.

The ventilation modes available are: -

Continuous Positive Pressure (CPAP) only when in the leakage ventilation mode.

-

Pressure Support Ventilation (PSV S) or spontaneous ventilation in the leakage ventilation or valve mode.

-

Pressure Support Ventilation with Back Up Rate (PSV ST)

-

Pressure Controlled Ventilation (PCV)

-

Pressure Assisted Controlled Ventilation (PACV)

-

Controlled Volume (CV):

-

Assisted Controlled Volume (ACV):

-

Synchronous Intermittent Mandatory Ventilation (SIMV)

An additional option available in dual-pressure level modes enables ventilation with a Target tidal volume, which requires the setting of additional parameters (see § Target Volume Ventilation). A set of surveillance systems for the patient ventilation and the ventilator itself is integrated to the apparatus. Some alarm parameters can be set by the clinician (see § Alarms and Defaults). A software-type key prohibits access to ventilation parameter settings and ventilation mode changes in order to distinguish between "clinician" usage and "patient" usage (see § Locking key). Additional oxygen from a “network” or “cylinder” type source can be provided. The input pressure must lie between 2.8 and 6 bars (280 to 600 kPa). The oxygen dosage is governed by the ventilator with relation to an adjustable FiO2 enrichment objective and can also be monitored by the ventilator (see § Oxygen supply). A SpO2 pulse oxymetry monitoring system with settable alarm thresholds is also possible by using a NONIN compatible sensor (see § SpO2 pulse oxymetry). The general technical data of the apparatus under normal conditions of use with regard to temperature, ambient pressure and humidity specified below are as follows:

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SUPPORTAIR® User’s Manual

-

Insufflation Flow: from 0 to 200 L/min (or dm3/min) in absolute(1) Maximum flow at 10 mbar = 190 l/min Maximum flow at 20 mbar = 160 l/min Precision of measurement: ± 10% above 15 l/min

-

Tidal Volume: from 50 to 1400 ml (or cm3) absolute(1) Precision of measurement: ± 20 ml up to 200 ml and ± 10% above

-

Insufflation Pressure: from 5 to 60 mbar (or hPa) absolute(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 80 mbar. -

Cycling rate: from 4 to 60 bpm (or breaths/min) absolute(1) 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 COMEPA MI COM 102-1 cell (see § Accessories and options) at 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

Note: Measurement of the FiO2 value is influenced by pressure variations. The calibration of the FiO2 cell takes place automatically on starting ventilation each time the machine is switched on with the O/I switch or when connected during ventilation but should be repeated regularly in the event of major changes to the pressure condition set of ± 10 mbar (see § Oxygen Supply).

(1)

-

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

-

Inspiration resistance of the ventilator: 2 mbar at 60 l/min

-

Exhalation resistance of the ventilator: 0.4 mbar at 60 l/min (without exhalation valve)

-

Internal volume of ventilator: 244 cm3

-

Exhalation block volume (for double branch option): 14 cm3

-

Level of sound pressure in accordance with standard NF EN ISO 17510-1: 30 dB(A)

-

A/C Electrical supply: 115/230 V ± 10% – 50/60 Hz Consumption: 80 VA nominal and 90 VA max

-

DC Electrical supply: 24 V ± 1.5 V -3.3 A max Consumption: 80 VA nominal

There are specific limitations for each mode – see § Parameter settings I - 15 - 00

SUPPORTAIR® User’s Manual

-

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 Vt ≈ 300 ml IPAP ≈ 20 mbar R ≈ 15 bpm Vt ≈ 500 ml IPAP ≈ 30 mbar R ≈ 15 bpm

10 h

8h

6h

Maximum ventilation parameters

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 of enclosure: 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 in double branch option

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: +10 to 35°C Humidity: 10 to 75% RH Atmospheric pressure: 700 to 1060 hPa

The pressure and flow sensors built into the apparatus are compatible with the ambient air, with oxygen alone or a mixture of air and oxygen Note: The flow measurements and thus the volume calculations that result are influenced by atmospheric pressure variations. A calibration of the flow sensor is I - 16 - 00

SUPPORTAIR® User’s Manual

recommended if atmospheric pressure has changed arround 100 hPa since the last calibration has been done (see § Sensor Calibration). For example, altimetry variation of 1000 m leads to a variation of flow 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. Note: A cooling ventilator is built into the SUPPORTAIR® in order to lower the internal temperature when it is excessive. When it runs after being automatically tripped in, it may generate a low continuous level of noise. DESCRIPTION OF THE DEVICE PRESENTATION The SUPPORTAIR® ventilator is delivered with a set of elements, namely: -

A mains power supply cord Code 2961400 with a maximum length of 1.8m.

-

A flexible hose Code 2739200 3 m long to connect to an external high pressure oxygen source (Unions compliant with EN 737-1).

-

A connection extension Code 3816000 with a maximum length of 1500 mm and a NONIN-compatible SpO2 finger clip sensor Code 5092300 comprising a cord with a maximum length of 900 mm.

-

A single use double branch patient circuit 1.6 m long with an exhalation valve and a proximal pressure tube.

-

Spare air input filters for fine particles Code 2963300

-

An FiO2 measurement kit Code 3814100 consisting of a COMEPA MI COM 102-1 measuring Cell (code 2964200), an adapting Deflector of the cell to a 15mm diameter « T » connector, a « T » Connector (22 M – 22 F – Ø 15 standard) and a Cord for connecting the oxygen cell to the apparatus with a maximum length of 200mm (two models are provided to adapt to the different possible connectors, depending on the different generations of the machines).

-

The present user manual.

Other accessories are available as optional extra (see § Accessories and options)

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SUPPORTAIR® User’s Manual

EXTERNAL INTERFACES AND FUNCTIONAL ORIFICES • Front face: “patient” interfaces and man/machine interface Patient return connection (Double Branch Option)

Display

Control panel

FiO2 external cell connection Output orifices for internal cooling (*)

Piloting of the exhalation valve

Proximal pressure socket

Main outlet of gases towards patient

• Rear face: Electrical interfaces and technical apertures Internal cooling air outlet apertures (*)

Transport handle

Main air inlet with air filter (*) On / Off switch And protective Oxygen inlet 280 to 600 kPa

Hook for holding mains cable (**)

Connection for alarm repeater

SpO2 sensor connection (with extension)

Internal cooling air inlet apertures (*) Battery cover RS232 serial port (***)

24 V DC socket

AC 115/230 V power socket

WARNING (*) It is essential to ensure that the apparatus air inlet and outlet are never blocked. WARNING (**) For the mains power cable to be held firmly in place, it must be inserted into its holding hook built into the battery cover and located below the mains power supply socket. I - 18 - 00

SUPPORTAIR® User’s Manual

To easily introduce the mains power cable into this holding system, it is necessary to present it on its section in the hook then to push it top to the bottom so that it takes by slip and natural rotation its final position. WARNING (***)The RS232 series communications port is sensitive to electrostatic discharges and it must only be handled after the usage precautions for this type of product have been made (earth the operator with an anti-static bracelet). CONTROL PANEL

Alarm(s) indicator light

Electrical supply indicators

Disabling – cancelling alarm(s) key and menu change

Indicator for internal battery load status

O2 100% enabling indicator light

Display

O2 100% during 2 minutes key

Ventilation status indicator Ventilation start/stop key

Validation key

Cursor movement keys, incrementation / decrementation of parameters and curves freeze or unfreeze (curves menu)

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SUPPORTAIR® User’s Manual

DISPLAY PRINCIPLES Several types of menu are proposed by SUPPORTAIR®: -

Ventilation parameters menu.

-

Alarm parameters menu.

-

Graphic monitoring menu (see § Graphic monitoring)

-

Alarms history menu (see § Display and Inhibition of alarms)

-

General configuration menu (see § General configuration)

-

Preferences menu (see § Preferences)

-

Curves configuration menu (see § Curves configuration)

-

Maintenance menus and its sub-menus: Voltages check, Historical record of anomalies (see § Maintenance).

Here, only the main displays of the main menus involving ventilation are shown: •

Ventilation parameters menu: Title and general informations: Ventilation mode, Battery, Exhalation valve, Counter

Navigation cursor

Graphic monitoring window or parameters zoom

Ventilation parameters menu

Alarm(s) window

Access to preferences menu Pressure graphic

•

Alarm parameters menu:

Title and general informations: Ventilation mode, Battery, Exhalation valve, Counter

Graphic monitoring window or parameters zoom

Alarms parameters adjustment (min and/or max) and graphic monitoring display

Alarm(s) window

Pressure graphic

Access to Historical record of anomalies

The other menus available are repeated and presented in development chapters in this manual.

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SUPPORTAIR® User’s Manual

LABELS / IDENTIFICATION AND INSTRUCTION INFORMATION Several labels or specific indications are affixed to the ventilator. They indicate the precautions to be taken for the correct use of the various elements of the apparatus and contribute to the traceability of the product.

PATIENT PROXIMAL PRESSURE CONNECTION

AIR OUTLET CONNECTION

EXHALATION VALVE CONNECTION

APPARATUS I/D LABEL

EXTERNAL FIO2 PULSE OXYMETRY CONNECTION

AIR INTAKE LABEL

24 V EXTERNAL POWER SUPPLY CONNECTION

MAINS POWER CONNECTION

EXTERNAL ALARM REPEATER CONNECTION

OXYGEN INLET

EXTERNAL SPO2 PULSE OXYMETER CONNECTION

PATIENT RETURN CONNECTION (Double Branch Option)

MARKING SHOWING "PRODUCT SENSITIVE TO CONNECTION BY 9-PIN DIRECTION ELECTROSTATIC DISCHARGE" SERIAL PORT (RS 232) OF INSTALLATION OF THE LABEL INTERNAL BATTERY (*): The serial number of the apparatus enables its date of manufacture to be identified by the letter indicating the decade (ex : K for 2000 to 2009), with the first of the last group of three figures and the last two in this group of three figures the month within the year (ex :... K . . . 409 indicating September, 2004). I - 21 - 00