Vitalograph Lung Monitor BT Smart User manual

Lung Monitor
BT Smart
Instructions for Use
MODEL 4000
© Copyright Vitalograph 2020 Current Edition (Issue 1, 05-Feb-2020) Cat. No. 09881

Vitalograph Ltd, UK
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.co.uk
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, International
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.eu
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph GmbH
Rellinger Straße 64a
D-20257 Hamburg
Germany
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.de
Technical Support
Telefon: [phone]
E-mail: [email protected]
Vitalograph Inc.
13310 West 99th Street
Lenexa, Kansas, 66215
USA
Toll Free: 800 255 6626
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.com
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph (Ireland) Ltd
Gort Road Business Park
Ennis, Co Clare, V95 HFT4
Ireland
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.ie
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, Hong Kong/China
P.O. Box 812
Shatin Central Post Oce
Hong Kong
E-mail: [email protected]
www.vitalograph.cn
Technical Support
Tel: [phone]
Email: [email protected]
© Copyright Vitalograph 2020
Current Edition (Issue 1, 05-Feb-2020)
Cat. No. 09881
Vitalograph is a registered trademark.
Vitalograph Branch Addresses
DT_0006 Issue 15

1. Main Components of the Vitalograph Lung
Monitor BT Smart
Figure 1 Vitalograph Lung Monitor BT Smart Components
1 User Buttons
2 Display
3 Flowhead
Down Button
Up Button
Enter Button
1.1. Features of the Vitalograph Lung Monitor BT Smart
• Measures PEF, FEF25-75, FEV1, FEV and the ratio
• Displays % of personal best PEF and FEV1
• PEF and FEV1 zones can be personalized
• Automatically assesses test quality
• Electronic records
• Stores 600 test sessions
Note: The FEV value represents the total expired volume recorded during
the blow.

2. Setting Up the Vitalograph Lung Monitor BT
Smart
To get the Lung Monitor BT Smart ready for use:
1. Remove the detachable battery door at rear of unit. Fit two
AAA 1.5V batteries. Replace battery door.
2. Turn on via the On/Off Button. (The same button is used
to power down.)
3. Attach a mouthpiece to the owhead, see Figure 2.
Figure 2. Mouthpiece inserted into owhead
4. If used for multiple subjects, Vitalograph intends that a
new Eco Bacterial Viral Filter (Eco BVF) be used for every
test subject to prevent cross contamination. Using a new
Eco BVF provides a signicant level of protection of the
subject, the device and the user against the risk of cross
contamination during spirometry manoeuvres. Eco BVF
and SafeTway mouthpieces are single use items and must
be disposed of after use.

3. Operating Instructions
If the device has just been unpacked or transported, ensure that it is
left sitting, fully powered and is at room temperature prior to testing.
3.1. Setting Personal Best (Reference) Values
Personal Best (reference) values can be set for peak ow (PEF)
and/or forced expiratory volume after 1 second (FEV1).
To set the Personal Best (reference) PEF:
1. Turn device on .
2. When device is ready for a test ( ), press the and
buttons together for 3 seconds.
3. Set the reference PEF value by pressing the button and
releasing when the value is reached. Press the to roll
back. The values will increase/decrease in values of 10. If
the button is kept depressed, the values will scroll faster.
4. Press ENTER to save the reference PEF value.
5. Press to exit, OR see step 6 to set the Best Test
(reference) FEV1:
6. Set the reference FEV1 value by pressing the button and
releasing when the value is reached. Press the to roll
back. The values will increase/decrease in values of 0.10.
If the button is kept depressed, the values will scroll faster.
7. Press ENTER to save the reference FEV1 value. The
device will return to the test screen.
Note: To de-activate zones, set both the PEF and FEV1 reference
values to 000/0.00.
3.2. Setting Management Zones
The Lung Monitor BT Smart can be set for use with 3 or 4 zone
management plans. The zones are factory set to 2 boundaries (90% &
95%) resulting in 3 Zones (0-90%, 90-95%, 95-100%). For 4 zones the
middle boundary is set last. The colour systems for each zone are:

Green Green
Top Boundary Yellow Yellow Top Boundary
Orange Middle Boundary
Bottom Boundary Red Red Bottom Boundary
3 Zone 4 Zone
To set boundary percentage values for 3 zones:
1. Turn device on, .
2. When device is ready for a test ( ), press the and
buttons together for approximately 10 seconds.
3. Set the top (Green/Yellow) boundary by pressing the or
button and releasing when the value is reached.
4. Press ENTER to save the boundary value.
5. Set the bottom (Yellow/Red) boundary by pressing the
or button and releasing when the value is reached.
6. Press to save the boundary value.
7. Only 2 boundaries are required for the 3 zone system, so
the next value should be selected as 0% (default). Press
Enter Button. The device will return to the test screen.
To set boundary percentage values for 4 zones:
1. Set the top and bottom boundaries – see steps 1-6 above.
2. Set the middle (Yellow/Orange) boundary by pressing the
button and releasing when the middle boundary value
is reached. The values will increase/decrease in values of
1% after an initial jump to the lower boundary value. If the
button is kept depressed, the values will scroll faster. This
boundary value cannot be set at a value that is greater than
the top boundary value or less than the bottom boundary
value.
3. Press to save the middle boundary value. The device
will return to the test screen.
3.3. Performing a Test
1. Fit a mouthpiece, SafeTway or Eco BVF lter onto the
device.

2. Turn the device on.
3. Sit down to blow into the device (unless a physician
advises otherwise).
4. When the device is ready for a test ( ), holding the head
high, breathe in as deeply as possible, hold the Vitalograph
Lung Monitor BT Smart ready in front of the mouth, see
Figure 3.
Figure 3. Holding device during test.
5. Holding the breath, place mouthpiece into the mouth, biting
the mouthpiece lightly, with the lips rmly sealed around it.
6. Blow out as HARD and as FAST and as LONG as possible
(the device will stop taking readings after 10 seconds). Be
careful not to block the mouthpiece with tongue or teeth. A
‘spitting’ action will give false readings.
7. Following each blow and at the end of the test session, the
PEF value will display and below that, PEF % Personal Best
results for that blow. If the Personal Best has been set, an
arrow indicates which colour management zone the blow
relates to.
8. Pressing the button will show the FEV1 result and
below that, FEV1 % Personal Best results for that blow. If
the Personal Best has been set, an arrow indicates which
colour management zone the blow relates to.
9. Pressing the button will show the FEV result.
10. Pressing the button again will show the FEV1/FEV
result.

11. Pressing the button again will show the FEF25-75 result.
12. When the blow icon shows, blow again ( ). Usually 3
blows are required.
13. To view the best test in the session (best PEF and best
FEV1), press . This value is recorded as the result for
the session in the device history.
Note: An exclamation mark ! indicates a poor quality blow and the
blow should be repeated.
The ! warning appears when Vext (extrapolated volume) is > 5% or
150mL of FEV (slow start of test) or a cough is detected in the rst
second.
If dizziness or fatigue is experienced during the test session, wait
until this passes before blowing again, or terminate the session.
3.4. Reviewing Previous Results
The Vitalograph Lung Monitor BT Smart can store up to 600 test
sessions. To view previously performed test sessions:
1. When the device is ready for a test ( ), press for
approximately 3 seconds.
2. The most recent test session displays. The best PEF result
will be displayed for approximately 3 seconds followed
by the best FEV1 result, followed by the best FEV result
followed by the best ratio of FEV1 and FEV and nally the
FEF25-75 result. The session number ‘1’ is also displayed,
this is the latest session.
3. View earlier test sessions by pressing the button.
4. Press . The device will return to the test screen.
3.5. Deleting All Results History
Caution: Results history cannot be recovered once it has been
deleted.
To delete entire history, i.e. all previously stored session results:
1. When the device is ready for a test ( ), press the and
buttons simultaneously for approximately 10 seconds.
2. A long beep indicates success. The device returns to the
test screen.

4. Power Management
The Lung Monitor BT Smart operates with 2 AAA 1.5V disposable
batteries. If the battery symbol ashes the batteries should be
replaced. Access the batteries by removing the battery door on the
underside of the device.
Note: Dispose of used batteries safely.
5. Cleaning & Hygiene
The Lung Monitor BT Smart is not designed or supplied as a ‘sterile’
device. Keep the device clean and dust free. If you suspect the
device is damaged or is measuring incorrectly, contact your medical
professional immediately.
The Lung Monitor BT Smart should continue to give reliable
measurements for up to three years in home use including
telemedicine applications. It should then be replaced with a new
device.
5.1. Cleaning in Single Patient Environment
For single patient use, the plastic mouthpiece may be used.
Weekly cleaning of the mouthpiece, outside surfaces and owhead
of the device is recommended. A cloth impregnated with 70%
isopropyl alcohol may be used. The plastic mouthpiece may be
washed in warm soapy water and then rinsed in clean water. The
device should be cleaned before and after an extended period of
storage.
5.2. Preventing Cross-Contamination of Subjects in Clinic use
For multi-patient use in a clinic or telemedicine environment
Vitalograph recommends the use of Eco BVF lters or, if these aren’t
available then SafeTway mouthpieces may be used based on the
customer own risk assessment and hygiene controls.
Before use by the next subject, the mouthpiece, outside surfaces
and owhead of the device should be cleaned with a cloth
impregnated with 70% isopropyl alcohol. The device should be
cleaned before and after an extended period of storage. If you
suspect that a device intended for multi-patient use has become
contaminated, it should be replaced.

When used in the clinic environment, it is recommended that
the device be replaced annually. There is no planned preventive
maintenance for this medical device.
6. Fault Finding Guide
Problem Fault
Symptoms: No ow measurements
Possible Solutions:
(In probable order)
The batteries may be low. Replace the
batteries.
The owhead may be damaged. Check
that the rotating vane is spinning freely.
Problem Fault
Symptoms: Cannot read user interface
Possible Solutions: The batteries may be low. Replace the
batteries.
7. Customer Service
For further assistance, setting up, using or maintaining the device
or to report unexpected operations or changes in performance,
contact Vitalograph, using the contact information at the start of
this manual. Also contact the healthcare provider on any changes to
the performance of the device, as a precaution.
Service and repairs should be carried out only by the manufacturer,
or by Service Agents approved by Vitalograph. Contact information
for approved Vitalograph Service Agents may be found at the start
of this manual.
Any serious incident that has occurred in relation to the device
should be reported to Vitalograph or its Authorized Representative
and the Regulatory Authorities of the country. Refer to the
Vitalograph contact information at the start of this manual.

8. Consumables and Accessories
Cat. No Description
28501 Eco BVF (100)
28572 Eco BVF + Disposable Noseclips (80)
40168 Plastic Mouthpiece 4000 series (20)
20303 Disposable Noseclips (200)
40167 Pouch Spare (x10)
20242 SafeTway Mouthpieces (200)
67201 Bluetooth Adaptor
9. Disposal
The device and Bluetooth Adapter must be taken to separate
collection at the product end-of-life. Do not dispose of these
products as unsorted municipal waste. The pouch can be disposed
of in unsorted municipal waste.
Used Eco BVFs and SafeTways, constitute minimally soiled waste
from human healthcare and should be disposed of in line with local
requirements. Eco BVFs are made from 100% polypropylene.
10. Explanation of Symbols
Symbol Description
Type BF equipment
VA Power rating
Direct current
Instructions for Use; operating instructions
Manufacturer
Date of Manufacture (include date in format yyyy-mm-dd)

Symbol Description

The device must be taken to separate collection
at the product end-of-life. Do not dispose of these
products as unsorted municipal waste
Serial Number
Device Order Number
Use by Date (Date format yyyy-mm-dd)
Keep Dry
Do not re-use
Non sterile
Recycle
QR code - matrix bar code. All information in the bar
code is included in the text under it
Other Labels
Battery status
Battery status Full
Battery status Half
Battery status Quarter
Battery status Empty (ashing)
Blow Now Symbol
!Bad Test Symbol
Memory 90% - 100% Full Icon
Flashes when memory reaches 100%

Symbol Description
Transmit Report Symbol
11. Description of the Vitalograph Lung Monitor BT Smart
The Vitalograph Lung Monitor BT Smart is an easy to use home
monitoring device designed to record key lung function parameters
for those with respiratory conditions, including cystic brosis and
transplant patients. The lung monitor can also be used in primary
and secondary care, occupational health and clinical studies.
11.1. Indications for Use
The Vitalograph Lung Monitor BT Smart is a respiratory monitor
which measures subject respiratory parameters PEF, FEV1, FEV
(total volume recorded during each blow) and FEF25-75. It also
displays % of personal best PEF, FEV1 and FEV1/FEV ratio. It is
designed for lung function testing adults and children, 5 years and
older, in the home and professional healthcare environments, e.g.
primary care, hospitals and occupational health centres. The device
is intended to be operated by the patient, under the supervision of a
healthcare provider.
12. Technical Specication
Product Respiratory Monitor Lung Monitor
BT Smart
Model 4000
Dimensions 109mm (length) x 63mm (width) x
42mm (height)
Weight 63g (not including batteries)
Flow Detection Principal Stator/rotor
Accuracy Better than ± 3% (FEV1, FEV), ±
10% (PEF, FEF25-75)
Back pressure Less than 0.15kPa/L/second @
14L/s

Measurement Range:
PEF: 25 – 840 L/min BTPS
FEF25-75: 25 – 840 L/min BTPS
FEV1, FEV: 0 – 9.99 L BTPS
Maximum test duration 6 seconds
! Bad Test Criteria Slow start of test (Vext>5%) or a
cough detected in the rst second
Power Supply 3V (2 x 1.5V AAA batteries)
Battery Life
3 months of use, 3 tests per day
(Batteries near the end of their
shelf life will have reduced
capacity.)
Product Life
6 Years for the main device. The
Eco BVF, SafeTway & nose clips are
7 years.
Operating temperature
range 17–37ºC
Operating humidity range 30%–75%
Ambient pressure range 850hPa–1060hPa
Performance standards: ATS/ERS 2019, ISO 23747:2015,
ISO 26782:2009
Safety standards EN60601-1, EN 60601-1-11
EMC Standards EN 60601-1-2
QA/GMP standards EN ISO 13485, FDA 21 CFR 820,
CMDR SOR/98-282, JPAL, MDSAP.
Communications Bluetooth
Bluetooth Adaptor
Requirements USB2.0/3.0
PC Requirements Windows® 7, Windows® 8 or
Windows® 10

13. Contraindications, Warnings, Precautions and
Adverse Reactions
1. No modication of this equipment is allowed. Any
unauthorised changes to the device may compromise product
safety and/or data and as such Vitalograph cannot be held
responsible and the device will no longer be supported.
2. The device should only be used under the supervision of a
healthcare professional.
3. The device is not designed as a sterile device. Always follow
the safety guidelines given by the manufacturer of cleaning
and disinfectant chemicals.
4. If used for multiple subjects, Vitalograph intends that a new
Eco Bacterial Viral Filter (Eco BVF) be used for every subject to
prevent cross contamination. Using a new Eco BVF provides a
signicant level of protection of the subject, the device and the
user against the risk of cross contamination during spirometry
manoeuvres. An Eco BVF is for single use only.
5. Spirometry is a valuable tool that provides important
information to clinicians which is used together with other
physical ndings, symptoms, and history to reach a diagnosis
(ATS/ERS 2019). And as such, spirometry may support or
exclude diagnosis, but it cannot make one.
6. Take care not to block the mouthpiece with the tongue or
teeth during testing. A ‘spitting’ action or cough will give false
readings.
7. Subject fatigue may occur during testing depending on the
subject’s characteristics e.g. age, health status. For safety
reasons, testing should be preferably done in the sitting
position, using a chair with arms and without wheels. Subject
can also take a break between tests.
8. All values displayed are expressed as BTPS values.
9. Time zero is determined using the back-extrapolated method,
from the steepest part of the curve.
10. Symptoms must take precedence over device measurements.
If the patient at home thinks that the device is not reading
correctly, they must advise the healthcare professional
immediately.

11. Do not expose the device to liquids other than cleaning liquids
specied.
12. Keep device dry. If the device gets wet, do not use it, and
contact Vitalograph using the contact information at the start
of this manual. Do not connect any part of this device to mains
power as there is a risk of injury especially if the device is wet.
13. The device is not intended to be used in the presence of
ammable liquids or gases, dust, sand or any other chemical
substances.
14. Service and repairs should be carried out only by the
manufacturer or by Service Agents specically approved by
Vitalograph.
15. RF communications equipment (including peripherals such
as antenna cables and external antennas), which emit
electromagnetic elds, should be used no closer than 30 cm
(12 inches) to any part of the device, including cables specied
by Vitalograph. Otherwise, degradation of the performance of
this equipment could result.
16. The device is a Type-BF applied part. The subject comes into
contact with the device, mouthpiece, SafeTway or Eco BVF
during use.
17. Take care during battery replacement or during Bluetooth
adaptor installation. An AAA battery and Bluetooth adaptor are
potential choking hazards for a small child. Adult supervision
is required at all times, when a child is using the device. The
battery door, when removed, has pointed corners which may
present a risk of injury.
18. The batteries should be removed if the device is intended to be
stored or left unused for an extended period of time.
19. Only approved accessories from the manufacturer should be
used with the device. It may be unsafe to use accessories,
detachable parts and materials not described in this document.
20. Non-Medical Electrical equipment used with the device, should
comply with its relevant IEC or ISO standard.
21. For the device to be used as intended, there is no requirement
to clean the supporting computer. If cleaning is required to
remove any visible soiling, this should be done as per the
computer manufacturer’s instructions.

14. CE Notice
Marking by the symbol indicates compliance of the Vitalograph
Model 4000 Lung Monitor BT Smart to the Medical Devices
Directive of the European Community.
The Vitalograph Model 4000 Lung Monitor BT Smart is intended for
use in a variety of Home and professional healthcare environments,
e.g. primary care, hospital wards and occupational health centres,
except for near active high frequency surgical equipment and the RF
shielded room of an ME system for magnetic resonance imaging,
where the intensity of electromagnetic disturbance is high. The
customer or the user of the Lung Monitor BT Smart should assure
that it is not used in such an environment.
The Model 4000 Lung Monitor BT Smart has been tested in
accordance with:
EN60601-1:2006 + A1:2013
Medical electrical equipment. General requirements for basic safety
and essential performance.
EN 60601-1-11: 2015
Medical electrical equipment. General requirements for basic safety
and essential performance. Collateral Standard: Requirements for
medical electrical equipment and medical electrical systems used
in the home healthcare environment.
EN 60601-1-2: 2015
Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.

EN 60601-1-2 - Emissions tests
Emissions test Compliance Electromagnetic
environment - guidance
RF emissions
CISPR 11 Group 1
The Model 4000 Lung
Monitor BT Smart uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
RF emissions
CISPR 11 Class B
The Model 4000 Lung
Monitor BT Smart is suitable
for use in all establishments,
including domestic
establishments.
EN 60601-1-2 Immunity tests
Immunity test Test level Compliance level
Reached
Electrostatic
discharge (ESD)
EN 61000-4-2
Contact: ± 8 kV
Air: ± 2 kV,±
4 kV,
± 8kV,± 15 kV
Contact: ± 8 kV
Air: ± 2 kV,± 4 kV,
± 8kV,± 15 kV
Radiated RF
EN 61000-4-3
3 V/m
80MHz to
2700MHz
3 V/m
80MHz to 2700 MHz
Proximity elds
from RF devices
EN 61000-4-3
9 to 28V/m
385 to
5785MHz
As per Table 9
EN60601-1-
2:2015
9 to 28V/m
385 to 5785MHz
As per Table 9
EN60601-1-2:2015

Medical Devices may be affected by mobile RF communications
equipment including cellular telephones and other personal
or household devices not intended for medical facilities. It is
recommended that all equipment used near the Vitalograph product
comply with the medical electromagnetic compatibility standard
and to check before use that no interference is evident or possible.
If interference is suspected or possible, switching off the offending
device is the normal solution, as is required in aircraft and medical
facilities.
Medical electrical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided.
15. FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order
of a physician.

16. EU Declaration of Conformity
Product: Respiratory Monitor 4000, Lung Monitor BT Smart
Vitalograph hereby ensures and declares that the above product
associated with these instructions for use, is designed and
manufactured in accordance with the following QMS regulations
and standards:
• European Medical Devices Directive {MDD} 93/42/EEC, as
amended.
This device is classied as IIa per Annex IX of the MDD
also meets the provisions of the Essential Requirements,
Annex I, via compliance with Annex II of the Medical
Devices Directive as per Article 11, section 3a, excluding
point 4 of Annex II.
• EN ISO 13485 Medical devices. Quality management systems.
Requirements for regulatory purposes.
Certifying Body: British Standards Institute {BSI}.
BSI Notied Body #: 2797
Certicate Nos. CE 00772, MD 82182
Signed on behalf of Vitalograph (Ireland) Ltd.
Frank Keane.
CEO, Vitalograph Ltd.