HYPAIR COMPACT Hardware Manual Ver H3 July 2014

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HYPAIR COMPACT FOREWORD Thank you for placing your trust and confidence in us by purchasing a MEDISOFT product.

The HYPAIR Compact system is designed for multiple pulmonary function testing, including the spirometry, measurement of static lung volumes by different methods, diffusing capacity testing (TLCO, TLNO) and respiratory muscles functions analysis. The basic configuration consists of spirometry testing coupled with a standard method for measuring lung volume (FRC He or FRC N2) and/or TLCO. Other testing options are available to enhance the functionality of your system, such as double diffusion (TLCO/TLNO), respiratory muscles studies (MIP,MEP), respiratory control (P01), resistances by interruption (Rint), rhinomanometry. The standard user manual package for HYPAIR Compact system includes 3 sections:

1

General information (G1-V.01.10.13 )

2

Hardware manual for HYPAIR (H3-V.26.05.14)

3

Software and functions manuals (classified by testing option)

!

Other supplementary documents will be required for external devices and selected testing

options. These documents are referenced in a table and can be found on the Manual CD. For additional information, please contact Medisoft Technical service. On the following pages, you will find the necessary instructions to operate your instrument effectively for practical uses. Please read this manual carefully before using the equipment for the first time. All the necessary measurements must be taken in order to ensure safe use of the equipment. The content of this document is subject to periodic update and revision. Beware that some items may be modified slightly in the latest version of the software, so features as described for the original version may not apply.

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HARDWARE

2.1 Introduction to HYPAIR Compact system 2.2 Overview 2.3 Pneumatic circuit 2.4 Accessory In/Ex valve 2.5 Setting up the connections

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2.1 Introduction to HYPAIR Compact system d

c

HYPAIR Compact System a HYPAIR Compact analyzer b Articulated arm

b

c

Head of patient valves

d

Computer and monitor

e

Medisoft trolley Standard elements

a

Optional elements

Top Rear

Right

Left

e

Bottom

Front

A complete HYPAIR Compact system consists of the following components: + HYPAIR Compact analyzer for measuring the flow, volume, and gas concentrations. The basic configuration usually includes spirometry testing coupled with a standard method for measuring lung volume (FRC He or FRC N2) and/or TLCO. + Pneumatic connector kit including an articulated arm, a Lilly type pneumotachograph, tubings, expiratory/inspiratory bags (optional) and accessory patient valves (optional for specified testing options). + Data collection system including a PC, monitor and printer, Microsoft Windows® operating system and our ExpAir® software program. ExpAir software has been designed for the operation of all Medisoft equipment. + Medisoft trolley Other testing options are available to enhance the functionality of your system, such as double diffusion (TLCO/TLNO), respiratory muscles studies (MIP,MEP), respiratory control (P01), resistances by interruption (Rint), rhinomanometry. 6 H3-09.07.14

2.2 Overview 2.2.1 Vertical model with respiratory bags - front view

2

g

a

f

h

e b d

i

j

Top

c

Left

Rear

Front

Right Bottom

HYPAIR Compact (vertical model with respiratory bags): Front view a Front panel

f Pneumotachograph

b Combined tubing connector

g

Arm

c Combine tubing

h

Patient valves head

d Heating wire connector

h

Expiratory bag (for TLCO; TLNO testing)

i

Inspiratory bag (for TLCO, FRC testing)

e

LED indicator

Standard elements

This vertical version has been designed for use with a trolley. The device enables exhaled gas analysis for FRC (He), TLCO (He) and TLNO/TLCO testing options.

Optional elements The patient valve system includes a pneumotachograph for measuring the flow and volume, an inspiratory bag for preparing the test gas mixture and an expiratory bag for standard exhaled air sampling. The pneumatic connection is set up through a combined tubing. 7 H3-09.07.14

2.2 Overview 2.2.1 Horizontal model with respiratory bags - front view

2

h f g

i

j

b

c

d Top

a

Left

Rear

Front

Right

e

Bottom

HYPAIR Compact (horizontal model with respiratory bags): Front view a Front panel

f Pneumotachograph

b Combined tubing connector

g

Arm

c Combine tubing

h

Patient valves head

d Heating wire connector

h

Expiratory bag (for TLCO; TLNO testing)

e

i

Inspiratory bag (for TLCO, FRC testing)

LED indicator

Standard elements Optional elements

This version has a horizontal layout which is suitable for desktop installation. It has the same structure and testing functions as the vertical version.

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2.2 Overview 2.2.3 Vertical model with demand valve

2

h g

j

a e f

b i

j

Top Rear

Left

d Front

Right Bottom

c

HYPAIR Compact (vertical model with demand valve): Front view a Front panel

f Pneumotachograph

b Combined tubing connector

g

Arm

c Combine tubing

h

Patient valves head

d Heating wire connector

i

Demand valve

e

i

Fast gas sampling port

LED indicator

Standard elements Optional elements

The device applies an alternative method for delivering the test gas mixture without using respiratory bags. This version can support some testing options that rely on inhaled/exhaled gas analysis, including: TLCO measurement (He or CH4), multi and single N2 wash-out (FRC N2, closing volume and N2 slope analysis). A fast gas sampling circuit can also be implemented for assessing the exhaled gas fraction in real time. This function is required for N2 wash-out, TLCO (CH4) and intra-breath TLCO testing. 9 H3-09.07.14

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2.2 Overview 2.2.2 Front panel connectors d

d

Vertical model a

b

c

c

a

a

d

Combined tube connector

b c

Horizontal model

d

HYPAIR Compact: Front panel connectors a

10 lines connector

b

6 lines connector

c

Heating wire connector: for the pneumotachograph

d

Gas sampling inlet: for fast gas analysis

b

c

Standard elements Optional elements

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2.2.3 Rear panel

2

f

a Top

c Left

Right

f Bottom

d a

b

d

b

c

e e

g Horizontal model

Vertical model

g

HYPAIR Compact: Rear panel a

Ventilator (12V DC)

e

Power entry (110/250 V AC- 50/60 Hz)

b

Serial port (connection to PC)

f

Exhaust

c

Bag vacuum pressure regulator

g

Gas inlets

d

Power switch (ON/OFF)

Standard elements

Optional elements NOTE: The number of gas inlets varies depending on the testing option. More than one gas type might be needed for the test. Example: Helium for FRC-He measurement TLCO gas mixture containing CO-He-O2 balanced in N2 Nitric oxide for TLNO test Pure oxygen for FRC N2 test and FRC He test Dry gas flushing (N2) Reference gas for CO2/O2 sensor calibration Heliox for inert gas wash-out testing… 11 H3-09.07.14

2.2.4 Version with N2 wash-out testing option

2

a Top

Left

b

Right

Bottom

d c

f e g

h

k

HYPAIR Compact: Rear panel a

Ventilator (12V DC)

j

i

b O2 sensor block c

USB reset button

d

Power switch (ON/OFF)

e

Power entry (110/250 V AC- 50/60 Hz)

f

Serial port (connection to PC)

g

Exhaust

h

Flush sample line (4,5 bar/65 psi)

i

Entry for calibration gas O2/CO2 (4,5 bar/65 psi)

j

Entry for O2 100% (4,5 bar/65 psi)

k

Entry for TLCO gas mixture (CH4, CO, O2, N2) (4,5 bar/65 psi)

Standard elements Optional elements

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2.3 Pneumatic circuit a

Head of the patient valves

Pneumotachograph

b d c 10 lines

6 lines

f

g

e

Pneumatic circuit a

Head of patient valves

d

Expiratory bag

b

Pneumotachograph

e

Combined tubing

f

g

c Inspiratory bag

Combined pneumatic connectors

Standard elements Optional elements

The pneumatic circuit is a set of components which provides the connection between the patient and the analyzer for flow measurement, administration of the test gas mixture and the exhaled gas sampling. The circuit is composed of: the head of patient valves, the pneumotachograph, inspiratory or expiratory bags (optional) and tubings. The combined tubing comprises several (6-10) lines which are numbered. It allows an easy connection between the valves / pneumotachograph and the analyzer interface. Head valves consist of various elements that could vary depending on the option.

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2.3.1 The pneumotachograph

2

c

d

a

b

Top Analyser

Patient Bottom

a

Flexible joint

b

Head with pneumatic pistons valves

c

Pneumotachograph

d

Filter and mouthpiece

The pneumotachograph

e

c

b

a

Outflow

Inflow

d a

Upstream pressure sensor (+)

b

Downstream pressure sensor (-)

c

Mesh

d

Heating wire connector

e

* Connector to fast sampling line Note: (*) only available for fast gas analysis (Fast TLCO-He or TLCO-CH4)

Assemble the two elements of the pneumotachograph by slightly rotating in 2 directions. These two elements are marked with red (proximal) and blue (distal) dots. Make sure that the 2 points are aligned for a good seal. 14 H3-09.07.14

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2.3.2 Patient valves The patient valve structure varies depending on testing option.

c

b

Standard version

a d The standard patient valve structure for use with HYPAIR Compact

h

f The combination between pneumatic elements is defined by the method in use: + For a standard administration of the gas mixture (TLCO, TLNO or FRC-N2…), the inspiratory bag e would be used. + Fast and direct gas distribution (without inspiratory bag) will need a demand valve . f

a

Valve body

b

Piston valve head

c

Port to pneumotachograph

d

Outlet to ambient air

g e

Standard elements Optional elements

+ For a standard gas analysis (expired air sampling), the expiratory bag g would be used. + For a fast gas analysis (TLCO fast, intra-breath TLCO), a direct sampling line h instead of expiratory bag would be used. + For some specified tests, accessory elements (In/Ex valves, adaptor…) will also be required. H3-09.07.14

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2 A

2.3.3 Variability of patient valves a

c

Valve system with Inspiratory/Expiratory bags

b

b

Supported testing options: TLCO (He, single breath) TLCO/TLNO FRC(He)

f

g

i

e

Exp Insp

c

B

Valve system with Inspiratory/Expiratory bags

b

a

j

Supported testing options: TLCO (He, single breath) TLCO (CH4, single breath)

f

i

Top Analyser

Patient

Insp Bottom

a

Valve body

e

Port to Expiratory bag

b

Piston head

f

Valve for gas inlet

c

Port to pneumotachograph

g

Connector to fast gas sampling line

d

Outlet to ambient air

h

Demand valve

i

Port to Inspiratory bag

j

Connector to fast gas sampling line

Standard elements Optional elements

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2.3.2 Patient valves

Valve system with

b

b

c

C Demand valve and Expiratory bag

a

h

Supported testing options: TLCO (He, single breath) TLCO/TLNO g

f e

d

Top

Exp

Analyser

Patient Valve system with

D demand valve and fast gas sampling line

j

b

b

c

Bottom

a

h

Supported testing options: TLCO (He or CH4, single breath) Intra-breath TLCO N2 wash-out testing (accessory In/ex valve is required) d

d

Accessory In/Ex valve a

Valve body

e

Port to Expiratory bag

b

Piston head

f

Demand valve gas inlet

c

Port to pneumotachograph

g

Connector to fast gas sampling line

d

Outlet to ambient air

h

Demand valve

i

Port to Inspiratory bag

j

Connector to fast gas sampling line

Standard elements Optional elements

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2.4 Accessory In/Ex valve for N2 wash-out and intra-breath TLCO testing options

e

a

b c Please see the next page for detailed descriptions a

HYPAIR main unit

b

Arm

c

Pneumatic valve system

d Combined tubing

d

e Combined tubing connector

Some HYPAIR units are equipped with a specified valve system for multi/single N2 wash-out and CH4 intra-breath TLCO testing options. This section will provide necessary instructions for implementing the valve elements to the pneumatic circuit for specific testing option. For detailed descriptions of the testing procedures, please refer to the corresponding software manuals. As mentioned above, the pneumatic circuit is a set of components which provides the connection between the patient and the analyzer unit for flow measurement, administration of the test gas mixture and the exhaled gas sampling. For this version, the basic configuration is composed of: the head of patient valves, the pneumotachograph, the demand valve. For multi N2 wash-out test, a supplementary In/Ex valve will be required. For single breath N2 wash-out tests (N2 slope study) and intra-breath TLCO tests, in addition to the In/Ex valve we also need a flow restrictor to control the flow rate during the exhalation phase.

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2.4.1 Implementing the In/Ex valve c 2

c 1

f i

b a

d 2

d 1

e

g Testing options

Required elements

Spirometry Single breath TLCO

+

Intrabreath TLCO

+

+

Multi N2 wash-out

+

+

Single N2 wash-out

+

+

h +

Top

+

Analyser

Patient a

Head of the patient valves

b

Pneumotachograph

c

Piston valve head (1 and 2)

Bottom

d Outlet to ambient air (1 and 2) e Demand valve (for administering the test gas mixture) f

Fast gas sampling line

g

In/Ex valve (implemented to d 1)

h Flow restrictor (implemented to g ) a Protection filter

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2.4.2 Pneumatic circuit for Spirometry

2 1

Expiration 1

Pneumotachograph

Inspiration 2 Sampling line

Piston heads

Demand valve

1 2 Patient

Pneumotachograph

1

2

Ambient air

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