MedChip Solutions SpiroConnect Manual de usuario

SpiroConnect

Spirometer

Operators Manual

Issue 1.12

Note: This issue of the Operators Manual, Issue

1.12, is applicable to SDM 1.12 when used with

FW 3.02.

July 2022

SpiroConnect Operators Manual 
MedChip Solutions Ltd. Page 2 of 31 001.105.GBR Issue 1.12 
Contents 
 
1Introduction ..............................................................................................................................................3 
1 MedChip Solutions COVID-19 Response............................................................................................3 
2Package Contents......................................................................................................................................5 
3Warnings and Cautions.............................................................................................................................6 
4Relative Contraindications for Spirometry...............................................................................................7 
5Intended Use.............................................................................................................................................7 
6Environment.............................................................................................................................................7 
7Getting Started..........................................................................................................................................8 
1 Installing SpiroConnect Data Manager Software.................................................................................8 
8Operation..................................................................................................................................................9 
1 Patient Selection:..................................................................................................................................9 
2 Unit Connection: ..................................................................................................................................9 
3 Forced Spirometry:.............................................................................................................................10 
4 Relaxed Vital Capacity:......................................................................................................................16 
5 Review Results:..................................................................................................................................17 
6 General information pertaining to the reviewing of examinations:....................................................18 
7 Calibration:.........................................................................................................................................19 
8 Settings:..............................................................................................................................................20 
9 Menu Bar options:..............................................................................................................................20 
10 Patient Database: ................................................................................................................................20 
11 Android application:...........................................................................................................................21 
12 ArtiQ AI Functionality:......................................................................................................................21 
9Battery Management...............................................................................................................................22 
Looking after your SpiroConnect...........................................................................................................23 
Cleaning..................................................................................................................................................23 
1 Unit Case Cleaning COVID-19 Update .............................................................................................23 
2 Turbine/Transducer Cleaning.............................................................................................................23 
3 Soft Carry Case Cleaning...................................................................................................................23 
Accessories.............................................................................................................................................24 
Servicing.................................................................................................................................................24 
Warranty and Liability............................................................................................................................24 
Software License Agreement..................................................................................................................25 
Trouble Shooting Information................................................................................................................25 
Electromagnetic Compatibility (EMC) ..................................................................................................25 
IT Network .............................................................................................................................................27 
Applied Parts ..........................................................................................................................................27 
Symbols..................................................................................................................................................28 
Classification..........................................................................................................................................28 
Specifications .........................................................................................................................................29 
 
 
 
 
 
 
 
 
 
 
 
 

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 3 of 31 001.105.GBR Issue 1.12

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.

The SpiroConnect turbine is a precision sensor and to avoid damage the following

precautions should be taken:

•Clean or sterilise the turbine in accordance with the instructions –See section 11

•Do not immerse the turbine in sterilising solution for more than 10 minutes

•The turbine should be dried in air, do not insert anything into the turbine to dry or clean

•Do not apply undue force when removing or inserting the turbine into the housing

1.1 MedChip Solutions COVID-19 Response

Spirometry should not be performed if the patient has any symptoms of COVID-19 infection

at the time of the test, or if they are known to have recently been in contact (within previous

10 days) with a confirmed case1.

MedChip Solutions recommends that a spirometry test using the SpiroConnect, should only

be performed using a bacterial/viral spirometry filter. These should be purchased from an

authorised SpiroConnect distributor to ensure they fit the device correctly.

After each use the unit should be wiped down with an alcohol infused wipe or other

medically approved anti-viral wipes such as Clinell wipes as per section “11.1 Case

Cleaning COVID-19 Update”.

The single use pulmonary filter should be safely disposed of immediately after the test by a

clinician wearing medical gloves.

Even though the SpiroConnect directs air downwards away from the clinician’s face, it is

recommended that a clinician is wearing personal protective equipment (PPE) that limits

aerosolized droplet acquisition2as the patient may cough after performing spirometry.

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 4 of 31 001.105.GBR Issue 1.12

The Bluetooth connectivity allows the clinician to remain at a safe distance from the patient

throughout the test and to be isolated from the patient, preferably behind a screen, in case

of a coughing event. Enhanced cleaning of the testing space should be carried out such as

wiping down surfaces with appropriate cleaners2.

If available, a room with mechanical air circulation should be used or a room where other

ways of ventilation are possible (e.g. opening windows). Ideally this should be in the region

of 6 room air changes per hour1.

The MedChip Solutions Covid-19 Response is based ATS guidance and on the ARTP

document “Risk minimisation in spirometry re-start” by Martin Allen3. Which includes:

•PCRS Spirometry in Primary Care - Guidance on reinstating spirometry in England

•ARTP Statement for the NHS NATIONAL RESPIRATORY PROGRAMME Task and

Finish Group Recommendations for undertaking risk-managed spirometry

Covid19 advice may be updated by the Medical Bodies and Governments. It is always

vital to act in line with the latest advice and any local Risk Assessment.

References

ARTP (Association for Respiratory Technology & Physiology) Statement for the NHS NATIONAL RESPIRATORY

PROGRAMME Task and Finish Group Recommendations for undertaking risk-managed spirometry.

2Meredith C. McCormack, MD MHS, David A. Kaminsky, MD, 2020 members of the ATS Proficiency

Standards for Pulmonary Function Testing Committee.

3https://www.artp.org.uk/write/MediaUploads/Standards/COVID19/ARTP_PCRS_spiro_re-

start_FINAL2.pdf

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 5 of 31 001.105.GBR Issue 1.12

2Package Contents

Your SpiroConnect comes complete with 2 Alkaline AA (LR6) batteries, quick start guide,

calibration certificate and the following items:

1 SpiroConnect spirometer

2 SpiroConnect Data Manager software on USB flash drive memory stick

(May be supplied by distributor on alternative format)

3a SpiroConnect Bluetooth dongle (alternative dongle 3b may be supplied)

4 Nose Clip

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 6 of 31 001.105.GBR Issue 1.12

3Warnings and Cautions

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

Caution: Possibility of injury or serious damage to the equipment

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

operation of the instrument.

WARNING: The instrument is not suitablefor 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

CAUTION: Read the manual before use

CAUTION: Cleaning solutions containing alcohol or chlorine, e.g. bleach, must not be used on the

turbine transducer. See section 11.2 on how to clean the turbine.

CAUTION: When removing or replacing the turbine, the mouthpiece holder must be facing away

from the SpiroConnect product name as shown above. Do not use excessive force.

CAUTION: The turbine must be orientated to the unlock position when removing or

replacing and turned to the lock position for use as shown on the label on top of the

device. Do not use excessive force.

WARNING: If you use multiple turbines in the same SpiroConnect then the calibration should be

checked each time the turbine is swapped and the calibration updated in line with the

recommendations on screen.

PLEASE NOTE: Activities That Should Be Avoided before Lung Function Testing

•Smoking and/or vaping and/or water pipe use within 1 h before testing (to avoid acute

bronchoconstriction due to smoke inhalation)

•Consuming intoxicants within 8 h before testing (to avoid problems in coordination,

comprehension, and physical ability)

•Performing vigorous exercise within 1 h before testing (to avoid potential exercise-induced

bronchoconstriction)

•Wearing clothing that substantially restricts full chest and abdominal expansion (to avoid

external restrictions on lung function)

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 7 of 31 001.105.GBR Issue 1.12

4Relative Contraindications for Spirometry

WARNING: Due to increases in myocardial demand or changes in blood pressure:

Acute myocardial infarction within 1 wk

Systemic hypotension or severe hypertension

Significant atrial/ventricular arrhythmia

Noncompensated heart failure

Uncontrolled pulmonary hypertension

Acute cor pulmonale

Clinically unstable pulmonary embolism

History of syncope related to forced expiration/cough

WARNING: Due to increases in intracranial/intraocular pressure:

Cerebral aneurysm

Brain surgery within 4 wk

Recent concussion with continuing symptoms

Eye surgery within 1 wk

WARNING: Due to increases in sinus and middle ear pressures:

Sinus surgery or middle ear surgery or infection within 1 wk

WARNING: Due to increases in intrathoracic and intraabdominal pressure:

Presence of pneumothorax

Thoracic surgery within 4 wk

Abdominal surgery within 4 wk

Late-term pregnancy

WARNING: Infection control issues:

Active or suspected transmissible respiratory or systemic infection, including

tuberculosis

Physical conditions predisposing to transmission of infections, such as hemoptysis,

significant secretions, or oral lesions or oral bleeding

Spirometry should be discontinued if the patient experiences pain during the maneuver.

Relative contraindications do not preclude spirometry but should be considered when

ordering spirometry.

The decision to conduct spirometry is determined by the ordering healthcare professional on

the basis of their evaluation of the risks and benefits of spirometry for the particular patient.

Potential contraindications should be included in the request form for spirometry.

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

aged 3 and older. 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 38 OC should be avoided.

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

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 8 of 31 001.105.GBR Issue 1.12

7Getting Started

Open the battery cover by pressing the ridged area on the battery cover towards the front of

the unit and simultaneously pulling outwards with your thumb, the lid will open like a door.

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:

NB: - If the software is supplied by the distributor then follow their installation instructions

- Administrative Rights are required for installation

- An installation is on a per-user basis. If multiple users on the same PC wish to use SDM under

their own login, it is necessary to run the installer for each user. The settings and database for

each user will be unique to that user, however the database can be shared between users if it is

configured to be in an accessible area for all users.

Run SpiroConnectDataManagerSetup_v1.XX.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.

Please note that PDF reader software needs to be installed on the system in order to view

PDF reports that are generated by the software or the Operators Manual, which can be

opened by clicking ‘Help’ and then ‘Open operators Manual’.

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

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 Operators Manual

MedChip Solutions Ltd. Page 9 of 31 001.105.GBR Issue 1.12

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 under All Programs->MedChip Solutions Spirometry.

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 for

tests to be performed.

Connect a disposable, CE-marked, mouthpiece or filter 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.

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

ready for a blow.

SpiroConnect Operators Manual

MedChip Solutions Ltd. Page 10 of 31 001.105.GBR Issue 1.12

8.3 Forced Spirometry:

After clicking the Forced Spirometry icon on the main screen, a screen with a start button

and temperature reading is displayed. This temperature reading is the ambient room

temperature as measured by the unit. If the operator wishes to modify the temperature

value, he may do so by clicking on the displayed temperature, and he will then be given the

opportunity to enter a temperature to over-ride the automatic temperature. The ambient

temperature is used for BTPS correction during inspiration. The same is true when

conducting Relaxed Spirometry. The temperature can only be over-ridden before

performing the first blow in a test sequence.

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

test.

Both flow-volume and volume-time graphs are shown and the unit will beep to indicate that it

is ready. At this point the operator can select a tab for a single graph or the Incentive tab, if

he wishes to view the FV graph, VT graph or Child Incentive graphic as an alternative to the

default Flow Volume loop and Volume Time graph during the live blow.

Instruct the patient to hold the mouthpiece between the teeth, and then apply the lips for an

airtight seal and breathe normally through the device. The patient should then be instructed

to breathe in rapidly until their lungs are completely full and the without delay, 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 until the graph border turns pink when a plateau in

the volume/time curve is detected, or to the point where they simply cannot squeeze any

more air out. They should then inhale as deeply and as rapidly as possible back to full lung

capacity, before removing the unit from their lips. After four seconds has passed without the

unit detecting any further flow, it will sound a beep and a test summary will be shown.

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