Vitalograph COMPACT 6600 User manual

COMPACT
Instructions for Use
MODEL 6600
© Copyright Vitalograph 2020 Current Edition (Issue 2, 17-Jun-2020) Cat. No. 09240

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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 2, 17-Jun-2020)
Cat. No. 09240
Vitalograph is a registered trademark.
Vitalograph Branch Addresses
of 20

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COMPACT - Instructions for Use
Contents
1. Main Components of the Vitalograph COMPACT ............................4
1.1. Features of the Vitalograph COMPACT....................................4
2. Setting Up the Vitalograph COMPACT ..............................................5
2.1. Vitalograph COMPACT Communications ................................6
3. Operating Instructions .......................................................................6
4. Power Management...........................................................................6
5. Cleaning & Hygiene ............................................................................7
5.1. Preventing Cross-Contamination of Subjects..........................7
5.2. Inspection of the Vitalograph COMPACT.................................7
6. Fault Finding Guide ............................................................................8
6.1. Software Check..........................................................................9
7. Customer Service...............................................................................9
8. Consumables and Accessories.........................................................9
9. Disposal ............................................................................................10
10. Explanation of Symbols ...................................................................10
11. Description of the Vitalograph COMPACT......................................11
11.1.Indications for Use ..................................................................12
12. Technical Specication....................................................................12
13. Contraindications, Warnings, Precautions and
Adverse Reactions ...........................................................................13
14. CE Notice ..........................................................................................15
15. FDA Notice........................................................................................17
16. EU Declaration of Conformity..........................................................17
17. Guarantee .........................................................................................18

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1. Main Components of the Vitalograph COMPACT
Figure 1 Main components of the COMPACT
A Power Supply
B Power LED
C I/O Ports - 4 x USB, 2 x Ethernet, 2 x Serial, 1 x DVI
D Flowhead
EFlowhead Connection Tubing
F Flowhead Carrier with security strap
G Colour LCD and Touch Panel Display
H Power Switch
1.1. Features of the Vitalograph COMPACT
• Touch screen colour display
• Audio feedback
• Auto-recognition of FVC single or multi-breath testing
• VC single or multi-breath testing
• Trending of test results
• Child incentive displays
• Audit Trail log
• Congurable Subject Demographics

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COMPACT - Instructions for Use
• Automatic storage of all test data
• Congurable Spirometry Reports
• Bronchodilator responsiveness testing
• Fully networked database (optional)
• Test QA ATS/ERS 2005 guidelines
• Pulse Oximetry Testing (SpO2)
• PCF (Peak Cough Flow) Test
• Challenge Testing – Mannitol, ATS 5-breath dosimeter, 2-min tidal
breathing and Exercise challenge
• Six Minute Walk Testing
• asma-1 Device Downloads/Uploads Module
• Simulation of ATS/ISO waveforms
• 12-Lead ECG module
• Support for the Health Level 7 (HL7) and GDT communication
standards
• Maximum Voluntary Ventilation (MVV) Test
2. Setting Up the Vitalograph COMPACT
1. Attach the owhead to the Vitalograph COMPACT using the dual silicone
tubing (Flowhead Connection Tube). Ensure that the ribbed tapping on the
owhead is connected to the ribbed side of the connection in the housing.
If tubing is connected the wrong way, spirometry results may appear to be
inverted (see Figure 1)
2. Only use the COMPACT with the low voltage power supply provided with the
device.
3. Connect the jack plug from the power supply into the socket at rear of the
COMPACT. Plug the mains plug into a suitable socket, operate the On/Off
button on the side of the instrument. The COMPACT is ready for use.
4. For guidance using Spirotrac software on the COMPACT refer to the
Spirotrac Instructions For Use available with the device.
5. To power down COMPACT:
a. Close the Spirotrac session, this will automatically log-off the current user
and power down the device. Or
b. Press the close button on the main toolbar.
Note: The device can be powered down by pressing and holding the On/Off
button but this is not recommended. Correct power-down is only achieved if one
of the two methods listed above are used.
If the device has just been unpacked or transported, ensure that it is left
sitting, fully powered, for at least an hour in order to reach room temperature
prior to testing.

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2.1. Vitalograph COMPACT Communications
Figure 2 COMPACT Port connections
1,2 Serial Ports x 2
3 DVI video output (Monitor) x 1
4,5 Ethernet x 2
6,7,8,9 USB x 4
Power
3. Operating Instructions
1. The Vitalograph COMPACT works with Vitalograph Spirotrac software. Refer
to Spirotrac Instructions for Use for operating instructions and details on:
• Entering Subject Data
• Conducting spirometry testing
• Printing a Report
• Calibration Verication
2. To enter text, touch the keyboard icon on the screen and use the
onscreen keyboard to enter the relevant details. To close the keyboard,
touch the X at the top right hand corner of the onscreen keyboard.
Alternatively a USB enabled keyboard may be used.
4. Power Management
The Vitalograph COMPACT must be powered using the 19V low voltage Power
Supply unit supplied with the device. When powered and switched ON the
LED on the front of the device will be green. The Power Supply unit should be
checked regularly and replaced when necessary.

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COMPACT - Instructions for Use
5. Cleaning & Hygiene
5.1. Preventing Cross-Contamination of Subjects
A spirometer is not designed or supplied as a ‘sterile’ device.
Vitalograph intends that a new Bacterial Viral Filter (BVF) be used for every
subject to prevent cross contamination. Using a new BVF provides a signicant
level of protection of the subject, the device and the user against cross
contamination during spirometry manoeuvres.
The interior of a Vitalograph owhead does not require decontamination where
a new BVF is used for each subject. The outside surfaces of the device and
owhead tube may becleaned with a 70% isopropyl alcohol impregnated cloth
to remove any visible soiling and for low level disinfection.
Where the user suspects that the owhead has become contaminated or where
local risk assessment identies a need for higher level of decontamination, then
it should be cleaned as per the instructions on ‘Cleaning and Hygiene’ on the
Vitalograph website.
5.2. Inspection of the Vitalograph COMPACT
A visual inspection is recommended on a routine basis: Remove owhead cone
and owhead end cap from the owhead. Examine ow conditioning mesh
lters for damage or contamination. If they are damaged or blocked, discard
and replace with new parts. Examine the O-rings on the Fleisch element and
replace if damaged. Re-assemble the cone and end cap.
It is recommended that an accuracy check is carried out following cleaning and
re-assembly as recommended in the ATS/ERS guidelines1.
Figure 3: Flowhead Assembly
1 Derived from terminology and guidance taken from ATS/ERS Standardisation of Spirometry 2019 Update Am J Respir Crit Care
Med 2019 Vol 200, Iss 8 pp e70-e88
1 Flowhead Complete
2 ‘O’ Rings
3 Flow End Cap
4 Flow Conditioning Meshes
5 Flowhead Cone
6 Fleisch Element
7 Flowhead Body
8Port Pressure Tappings
Lubrication: Silicone Grease

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6. Fault Finding Guide
Problem Fault Symptoms: • Not measuring ow
Possible Solutions:
(In probable order)
• Ensure tubing is connected correctly.
Ribbed side of tubing should be connected
to ribbed half of the connector on the
Vitalograph device.
Problem Fault Symptoms: • Incorrect or no volume measurements
Possible Solutions:
(In probable order)
• Ensure tubing is connected correctly.
Ribbed side of tubing should be connected
to the ribbed half of connector on the
Vitalograph device.
• Ensure that connectors are clear of
obstruction or dirt and are inserted fully.
• Ensure tubing is not kinked or squeezed.
Problem Fault Symptoms: • Excessive calibration drift
Possible Solutions:
(In probable order)
• Clean owhead thoroughly.
• Contact the nearest dealer for replacement.
Problem Fault Symptoms: • Test performed but does not show on
screen
Possible Solutions:
(In probable order)
• Ensure correct device is selected in Tools >
Device
• Ensure device is connected to PC correctly.
• Ensure tubing is connected correctly
between owhead and device (same colour
connector at both ends).
Problem Fault Symptoms:
• Communication error message appears
when entering the Test screen, the
Accuracy Check screen or the Calibration
Update screen
Possible Solutions:
(In probable order) • Ensure that device is attached correctly.
Problem Fault Symptoms: • Accuracy check variations > +/- 3%
Possible Solutions:
(In probable order)
• Recheck Calibration with reference to
Spirotrac Instructions for Use
• Was correct syringe volume entered?
• Ensure tubing connectors are clear of
obstruction or dirt and are inserted fully.
• Ensure tubing is not kinked or squeezed.
• Ensure owhead is clean.

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COMPACT - Instructions for Use
Problem Fault Symptoms:
• Test begins automatically
• Volume accumulates automatically without
the subject blowing
• Very small VC or FVC test displayed
Possible Solutions:
(In probable order)
• Flowhead and/or tubing not stationary at
start of test. Hold them steady until the
‘Blow Now’ prompt appears.
• Return to Main Menu and re-enter the test
routine.
6.1. Software Check
Information about Spirotrac is available in the ‘About’ box. This information may
be used when contacting Vitalograph or a service agent with queries.
To access the ‘About’ box:
• Select About from the Help menu.
To launch the Help le:
• Select User Training Manual from the Help menu.
7. Customer Service
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
Type Cat. No Description
Consumables 28350 BVF Bacterial Viral Filters (50)
20303 Noseclips (200)
28501 Eco BVF – Bacterial/Viral Filters (100)
28572 Eco BVF and Disposable Nose Clip (80)
28554 2820 Eco BVF with Bite Lip (75)
28553 2820 Eco BVF with Bite Lip and Disposable
Noseclip (75)
Accessories 36020 2040 Precision Syringe 3-L

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42084 Flow Conditioning Meshes (10)
67252 USB Cable
67181 COMPACT 19V Power Supply
61030 Flowhead Complete
42029SPR Flowhead Connection Tube
41530 Bluetooth Dongle
Compatible
Devices 41300 12-Lead BT ECG (IEC)
41303 12-Lead BT ECG (AHA)
70453 Pulse Oximetry Finger Probe USB
79400 2120 Hand Held In2itive™ Spirometer
40400 4000 Respiratory Monitor asma-1™ USB
Software 70201 7000 Spirotrac Network Licence
9. Disposal
The device must be taken to separate collection at the product end-of-life. Do
not dispose of these products as unsorted municipal waste.
Used BVFs constitute minimally soiled waste from human healthcare and
should be disposed of in line with local requirements. BVFs are made from
polypropylene.
10. Explanation of Symbols
Symbol Description
Type BF equipment
Class II
VA Power rating
Direct current
Instructions for Use; operating instructions
Manufacturer

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COMPACT - Instructions for Use
Year of Manufacture (Date format YYYY-MM-DD)
USB connector
The device must be taken to separate collection at the product
end-of-life. Do not dispose of these products as unsorted
municipal waste
Fragile, handle with care
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
11. Description of the Vitalograph COMPACT
The Vitalograph COMPACT is a desktop medical workstation designed for use
by trained medical professionals for physiological measurements in a variety
of professional healthcare environments, e.g. primary care, hospitals and
occupational health centres. Test data is automatically stored to the relevant
subject record. The software running on the COMPACT allows it to be used as a
standalone lung function testing device. In a clinical setting, the measurements
obtained from a lung function test form part of the various ndings of a
physician in the detection, diagnosis and control of chest diseases. Spirometry
may support or exclude diagnosis, but it cannot make one. The COMPACT can
also be used with other accessory devices to offer Pulse Oximetry, Six Minute
Walk Test, and 12-lead ECG testing.

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11.1. Indications for Use
Vitalograph COMPACT is intended for use by, or on the order of, a physician in
a hospital or clinic setting. It is designed for use on both adult and paediatric
patients. The device is a desktop based spirometer or may be used to connect
to compatible devices to acquire, view, store and print the device output. The
device is intended for use by trained medical professionals. Apart from this
instruction manual, there are no other training requirements for the medical
professional.
12. Technical Specication
Product Vitalograph COMPACT
Model 6600
Flow Detection Principal Fleisch type pneumotachograph
Volume detection Flow integration sampling @ 100Hz
Volume Accuracy Within ±3%
Flow Measurement
Range
Max. ow rate ±960 L/min (±16 L/s)
Min. ow rate ±1.2 L/min (±0.02 L/s)
PEF Accuracy Within ±10%
Back pressure Less than 0.1kPa/L/sec @ 14L/sec
Operating temperature
range
ISO26782 limits: 17–35ºC
Design limits: 10–40ºC
Performance standards
the Vitalograph
COMPACT meets or
exceeds
ATS/ERS 2005, ISO 23747:2015, ISO 26782:2009,
Safety standards EN 60601-1:2006 + A1:2013
EMC Standards EN 60601-1-2:2015
QA/GMP standards EN ISO 13485, FDA 21 CFR 820, CMDR SOR/98-
282 & JPAL MO# 106
Dimensions 375 mm x 235 mm x 110 mm
Weight 2.5 kg net
Communications USB x minimum 4, Serial x 2, Ethernet x 2, DVI
Video output
Power Supply 19V DC Power Supply
Operating System Windows 7 Embedded
Processor AMD FT1 Mobile Dual-core T56N

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COMPACT - Instructions for Use
RAM 8GB
Screen 12.1” LCD 1024x768 pixel
13. Contraindications, Warnings, Precautions and Adverse
Reactions
1. No modication of this equipment is allowed. Any unauthorised changes to
the Vitalograph COMPACT 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 COMPACT is not designed as a sterile device. Always follow the
safety guidelines given by the manufacturer of cleaning and disinfectant
chemicals.
3. Vitalograph intends that a new Bacterial Viral Filter (BVFTM) be used for
every subject to prevent cross contamination. Using a new BVF provides a
signicant level of protection of the subject, the device and the user against
cross contamination during spirometry manoeuvres. A BVF is for single use
only.
4. 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).
5. When using the COMPACT ensure that the owhead connecting tube is not
pinched or trapped as spirometry results may appear to be inverted.
6. Take care not to block the mouthpiece with tongue or teeth during testing. A
‘spitting’ action or cough will give false readings.
7. Subject fatigue may occur during spirometry 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 may also take a break between
tests. When the COMPACT device is used a subject fatigue warning will
appear after 8 manoeuvres.
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. Do not expose the COMPACT to liquids.
11. The COMPACT should not be used in the presence of ammable liquids or
gases, dust, sand or any other chemical substances.
12. All spirometry standards recommend checking the accuracy of lung
function measuring devices daily with a 3-L syringe to validate that the
instrument is measuring accurately. The COMPACT should never be
outside accuracy limits. Accuracy should be checked after cleaning or
disassembling the spirometer for any reason, after adjusting calibration or if
the owhead or device has been dropped.
13. Service and repairs should be carried out only by the manufacturer or by

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Service Agents approved by Vitalograph.
14. Maintenance must not be performed while the device is in use by a subject.
15. Use of accessories and cables other than those specied or provided by
Vitalograph for this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of the COMPACT and
result in improper operation.
16. Non-medical equipment must be kept outside the subject environment
i.e. any area in which intentional or unintentional contact between the
subject and parts of the system, or some other persons touching part of the
system, can occur.
17. Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the COMPACT, including cables specied by
Vitalograph. Otherwise, degradation of the performance of this equipment
could result.
18. Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
19. The applied part is the owhead. This along with the BVF, are the contact
points for the subject during a spirometry session. There are no adverse
effects if the subject comes into contact with any other part of the
COMPACT device.
20. Only use the Vitalograph COMPACT with the power supply provided.
Attempted use with other power sources may cause irreparable damage
and invalidate the warranty. The output from the power supply is 19 volts
DC.
21. The device is susceptible to electrostaticdischarge. Occasional ickering of
the screen and switching off of the device could occur. To restore function,
press the On/Off switch.
14. CE Notice
Marking by the symbol indicates compliance of the Vitalograph Model
6600 COMPACT to the Medical Devices Directive of the European Community.
The Vitalograph Model 6600 COMPACT is intended for use in a variety of
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 COMPACT should assure that it is not used in such
an environment.

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COMPACT - Instructions for Use
The Model 6600 COMPACT has been tested in accordance with:
EN 60601-1:2006 + A1:2013 - Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
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 60601-1-2:2015- Emissions tests
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The Model 6600 COMPACT 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 6600 COMPACT is suitable
for use in all establishments, including
domestic establishments and those
connected to the public mains network
(e.g. at home and doctor’s oces in
residential areas)
EN 60601-1-2:2015-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
Electrical fast
transient/burst IEC
61000-4-4
±0.5, ±1 & ±2kV
100kHz
±0.5, ±1 & ±2kV
100kHz
Surge
IEC 61000-4-5
±1kV dierential mode
Device is identied as Class
II unearthed equipment
therefore common mode
testing is omitted.
1kV

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Voltage dips, short
interruptions on
power supply input
lines IEC 61000-4-11
>95% drop, 0.5 cycles, 0o, 45o,
90o, 135o, 180o, 225o, 270o, 315o
>95% dip, 1 cycle
30% dip, 25 cycles
240V AC, 50Hz
>95% drop, 0.5
cycles, 0o, 45o, 90o,
135o, 180o, 225o,
270o, 315o
>95% dip, 1 cycle
30% dip, 25 cycles
240V AC, 50Hz
Conducted RF
EN 61000-4-6
6Vrms
0.15-80MHz
80% AM
6V/m ISM/amateur
radios bands
0.15-80MHz
80% AM
Radiated RF
EN 61000-4-3
3V/m, 1KHz
80MHz to 2700MHz
3V/m, 1KHz
80MHz to
2700MHz
Power frequency
(230V, 50Hz and
120V, 60Hz)
magnetic eld
30A/m 30A/m
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 (refer to section Contraindications, Warnings, Precautions and
Adverse Reactions).
15. FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order of a
physician.

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COMPACT - Instructions for Use
16. EU Declaration of Conformity
Product: 6600 Vitalograph Compact
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.

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17. Guarantee
Subject to the conditions listed below, Vitalograph Ltd. and its associated
companies, (hereinafter called the Company) guarantee to repair or at its option
replace any component thereof, which, in the opinion of the Company is faulty
or below standard as a result of inferior workmanship or materials.
The conditions of this Guarantee are:
1. This Guarantee shall only apply to hardware defects which are notied
to the Company or to its accredited distributor within 1 year of the date
of purchase of the equipment, unless otherwise agreed in writing by the
Company.
2. Software (meaning computer software, or user installable modules) is
guaranteed for 90 days from the date of purchase.
3. The Company warrants that the software when correctly used in
conjunction with the hardware will perform in the manner described in
the Company’s literature and user manuals. The Company undertakes to
rectify at no expense to the customer any software failure notied within
the period stated above, provided that the failure can be recreated and the
software has been installed and used in accordance with the user manual.
Notwithstanding this clause, the software is not warranted to be free of
errors.
4. This Guarantee does not cover any faults caused by accident, misuse,
neglect, tampering with the equipment, use of consumable items or parts
not approved by the Company, or any attempt at adjustment or repair
other than by personnel accredited by the Company, nor does it cover
reinstatement of any conguration changes caused by the installation of
any software.
5. If a defect occurs, please contact the supplier from whom it was purchased
for advice. The Company does not authorize any person to create for it any
other obligation or liability in connection with Vitalograph® equipment.
6. This Guarantee is not transferable and no person, rm or company has any
authority to vary the terms or conditions of this guarantee.
7. To the maximum extent permitted by law, the Company does not accept
liability for any consequential damages arising out of the use of, or inability
to use any Vitalograph® equipment.
8. This Guarantee is offered as an additional benet to the Consumer’s
statutory rights and does not affect these rights in any way.

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