MedChip Solutions SpiroConnect Manuale utente

SpiroConnect

Spirometer

Operating Instructions

Issue 1.2

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 2 of 26 001.105 Issue 1.2

Contents

1Introduction ............................................................................................................................................3

2Package Contents ...................................................................................................................................4

3Warnings and Cautions...........................................................................................................................5

4Contraindications....................................................................................................................................5

5Intended Use...........................................................................................................................................6

6Environment ...........................................................................................................................................6

7Getting Started........................................................................................................................................7

7.1 Installing SpiroConnect Data Manager Software................................................................................7

8Operation................................................................................................................................................9

8.1 Patient Selection: ................................................................................................................................9

8.2 Unit Connection: ................................................................................................................................9

8.3 Forced Spirometry: ...........................................................................................................................10

8.4 Relaxed Vital Capacity:....................................................................................................................12

8.5 Review Results: ................................................................................................................................14

8.6 General information pertaining to the reviewing of examinations: ...................................................15

8.7 Calibration:.......................................................................................................................................15

8.8 Settings:............................................................................................................................................17

8.9 Menu Bar options: ............................................................................................................................17

8.10 Patient Database: ..............................................................................................................................17

9Battery Management ............................................................................................................................18

10 Looking after your SpiroConnect .........................................................................................................18

11 Cleaning ...............................................................................................................................................19

12 Accessories...........................................................................................................................................19

13 Servicing ..............................................................................................................................................20

14 Warranty and Liability..........................................................................................................................20

15 Software License Agreement................................................................................................................21

16 Trouble Shooting Information ..............................................................................................................21

17 Electromagnetic Compatibility (EMC).................................................................................................22

18 Symbols................................................................................................................................................24

19 Classification ........................................................................................................................................25

20 Specifications .......................................................................................................................................25

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 3 of 26 001.105 Issue 1.2

1Introduction

Thank you for choosing the SpiroConnect from MedChip Solutions. Please take a moment to

familiarise yourself with the instructions for use detailed in this manual and for further

information please refer to our website: www.medchipsolutions.com.

The SpiroConnect transmits real-time spirometric flow and volume data followed by diagnostic

quality spirometry indices to a PC running SpiroConnect Data Manager software over a

Bluetooth connection.

The spirometer is compact, battery operated, and fully portable.

The spirometer uses the MedChip Solutions turbine transducer. This is an extremely stable form

of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and

Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature

corrections. This transducer is insensitive to the effects of condensation and temperature and

avoids the need for individual calibration prior to performing a test.

The vertical turbine technology employed in the SpiroConnect ensures exceptional

performance at low flows exceeding the ATS/ERS requirements to respond to flows as low as

0.025l/s.

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 4 of 26 001.105 Issue 1.2

2Package Contents

1 SpiroConnect spirometer

2 SpiroConnect Data Manager software on USB flash drive memory stick

(May be supplied by distributor on alternative format)

3 SpiroConnect dongle

4 Carrying pouch

5 2 Alkaline AA cells

6 Nose Clip

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 5 of 26 001.105 Issue 1.2

3Warnings and Cautions

Caution: Possibility of injury or serious damage

Warning: conditions or practices that could result in personal injury.

Please Note: Important information for avoiding damage to the instrument or facilitating

operation of the instrument.

CAUTION: Read the manual before use

WARNING: The instrument is not suitable for use in the presence of explosive or flammable gases,

flammable anaesthetic mixtures or in oxygen rich environments.

WARNING: The use of portable phones or other radio frequency (RF) emitting equipment near the

system may cause unexpected or adverse operation

WARNING: Medical electrical equipment needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided in the accompanying

documents

WARNING: Portable and mobile RF communications equipment can affect medical electrical

equipment

WARNING: Equipment should not be used adjacent to or stacked with other equipment and that if

adjacent or stacked use is necessary, the equipment or system should be observed to verify normal

operation.

WARNING: The USB socket on the device is for factory use only. Do not make any connection to this

socket.

PLEASE NOTE: The product you have purchased should not be disposed of as unsorted

waste. Please utilise your local WEEE collection facilities for the disposal of this product.

WARNING: No modification of this equipment is allowed

4Contraindications

WARNING: Do not use in the presence of a known or suspected respiratory infection

WARNING: Do not use when haemoptysis (coughing up blood) of unknown origin is present

WARNING: Do not use in the presence of pneumothorax (collapsed lung)

WARNING:Do not use in the presence of unstable cardiovascular status: recent (within one month)

myocardial infarction (heart attack), uncontrolled hypertension or pulmonary embolism

WARNING:Do not use in the presence of uncontrolled hypertension or history of haemorrhagic

cerebrovascular event (stroke)

WARNING:Do not use in the presence of recent thoracic abdominal or eye surgery

WARNING:Do not use in the presence of nausea, vomiting or pain

WARNING: Do not use in the presence of confusion or dementia

WARNING: Do not use in the presence of thoracic or abdominal aneurysms

WARNING: Do not use on patients with a history of syncope (fainting) associated with forced

exhalation

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 6 of 26 001.105 Issue 1.2

5Intended Use

The intended use of the SpiroConnect is to provide spirometry measurements used for the

diagnosis of common respiratory diseases such as asthma and COPD in adults and children

over 5. The SpiroConnect is intended to be used in doctors’ offices, hospitals and clinics.

6Environment

The SpiroConnect is designed for routine clinical use in an office environment. Use in

temperatures outside the range 10 to 40 OC should be avoided.

The environment should be free of excessive vibrations, and sources of electrical noise.

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 7 of 26 001.105 Issue 1.2

7Getting Started

Insert 2 AA size alkaline batteries as shown below taking care to observe the correct polarity:

WARNING: do not touch the patient when the battery cover is removed.

7.1 Installing SpiroConnect Data Manager Software

The SpiroConnect DM software is supplied on a USB flash drive memory stick together with this

user manual.

Install the software as follows:

N.B. If the software is supplied by the distributor then follow their installation instructions

Run SpiroConnectDataManagerSetup_v1.00.exe. There is no need to run any of the other

executable files on the drive, these will be automatically run during installation.

Please ensure the SpiroConnect Dongle is not plugged in to the USB port during installation.

After installation completes, plug the SpiroConnect Dongle into a free USB port, and wait until

Windows completes loading the correct drivers for the device and reports it as being ready for

use.

At this point, installation is complete and the system is ready for use.

When the application is launched it will automatically check for an updated software version if

the PC is connected to the internet. If an updated version is available, the operator will be

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 8 of 26 001.105 Issue 1.2

taken to a download page where he can download the installer for the newer version. This file

should be downloaded and then run to complete the update.

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 9 of 26 001.105 Issue 1.2

8Operation

WARNING: Do not attempt to connect the SpiroConnect to the PC using the USB socket on the

SpiroConnect device via USB cable.

WARNING: keep the patient away from the PC during use.

Start the SpiroConnect Data Manager software by clicking on the desktop icon, or from the

Windows Start Menu.

The Home Screen will then be displayed:

8.1 Patient Selection:

Before performing a test, click on in order to open the Patient Selector. Select an existing

patient, or click ‘Create New’ to create a new patient. Click ‘Choose Selected’ when the

desired patient is selected. The program will return to the screen shown above.

From this screen a forced spirometry test or relaxed vital capacity test may be selected.

8.2 Unit Connection:

Before ‘Start’ is clicked to initiate a test, the unit needs to be powered on and connected in

order for tests to be performed.

Connect a disposable or clean reusable, CE-marked, mouthpiece onto the mouthpiece holder

of the spirometer.

Turn the unit on at any point by pressing and releasing the power button.

The LED indicator will flash blue at a fast rate for a few seconds whilst connection with

SpiroConnect Dongle is established, and then change to a slow blue flash whilst connection

with the SpiroConnect Data Manager application is established, finally displaying solid blue

once ready. will also be displayed in the bottom left hand corner of the PC

application, indicating successful connection and approximate remaining battery capacity.

SpiroConnect Instructions for Use

MedChip Solutions Ltd. Page 10 of 26 001.105 Issue 1.2

Once ‘Start’ is clicked to initiate a test, the LED shows solid green to show that the unit is ready

for a blow.

8.3 Forced Spirometry:

Press in the bottom right corner of the Spirometry Examination screen to initiate the test.

A flow-volume graph will be shown and the unit will beep to indicate that it is ready. At this

point the operator can select the Volume/Time or Incentive tab, if he wishes to view the VT

graph or Child Incentive graphic as an alternative to the default Flow Volume loop during the

live blow.

Instruct the patient to inhale as deeply as possible, then place the unit to their lips – ensuring a

good seal – and blast out the air in their lungs as fast as they can and continue, until they

cannot squeeze any more air out of their lungs. They should aim to exhale for at least 6

seconds – the graph border will turn green after 6 seconds as a visual aid to assist with this.

They should then inhale as deeply and as rapidly as possible, before removing the unit from

their lips. After two seconds has passed without the unit detecting any further flow, it will sound

a beep and a test summary will be shown.

All parameters that have been selected for display in Settings are shown, along with the

normal value (if available), percentage change from Best Base blow (if the blow is a Post blow),

blow quality assessment, overall examination quality assessment and interpretation. Selecting

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