Vitalograph Compact User manual

Compact
Instructions for Use
MODEL 6600
© Copyright Vitalograph 2023 Current Edition (Issue 2, 09-Feb-2023) Cat. No. 09220
Rx Only

2Page
ENG
DT_0006 Issue 17
A Global Leader in Respiratory Solutions
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Vitalograph Ltd, UK
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.com
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.com
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.com
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.com
Technical Support
Tel: [phone]
Email: [email protected]
© Copyright Vitalograph 2023
Current Edition (Issue 2, 09-Feb-2023)
Cat. No. 09220
Vitalograph is a registered trademark.
Vitalograph Branch Addresses
of 20

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Vitalograph COMPACT - Instructions for Use
Contents
1. Indications for Use .............................................................................4
2. Contraindications, Warnings, Precautions
and Adverse Reactions ......................................................................4
3. Main Components of the Vitalograph Compact ..............................7
3.1. Features of the Vitalograph Compact ......................................8
4. Setting Up the Vitalograph Compact ................................................8
4.1. Compact Communications.......................................................9
5. Operating Instructions .......................................................................9
6. Power Management.........................................................................10
7. Cleaning & Hygiene ..........................................................................10
7.1. Preventing Cross-Contamination of Subjects........................10
7.2. Inspection of the Vitalograph Compact .................................10
8. Fault Finding Guide ..........................................................................13
8.1. Software Check........................................................................14
8.2. Product Useful Life Checks.....................................................15
9. Customer Service.............................................................................15
10. Consumables and Accessories.......................................................15
11. Disposal ............................................................................................16
12. Explanation of Symbols ...................................................................16
13. Description of the Vitalograph Compact ........................................17
14. TechnicalSpecication....................................................................18
15. CE Notice ..........................................................................................19
16. FDA Notice........................................................................................22
17. EU Declaration of Conformity..........................................................23
18. Guarantee .........................................................................................24

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1. Indications for Use
The Vitalograph Compact is a medical workstation which measures subject
respiratory parameters and is capable of centralising data from external cardio-
pulmonary related testing devices. It is intended for use by trained healthcare
professionals in a variety of professional healthcare environments, e.g. primary
care, hospitals, clinics and mobile clinics including occupational health
settings. The device is designed for use on adult and paediatric patients from
the age of 5 years.
Patients below the age of 5 years can be tested providing they can cooperate
with the test instructions from the healthcare professional. The device
functionality includes integrated spirometry and related pulmonary function
testing including respiratory muscle strength assessments.
Note: 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.
Apart from this instruction manual, there are no other training requirements for
the healthcare professional
2. 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. Any changes to the operating system or additional unapproved installations
must be validated by the end user.
3. The Compact is not designed as a sterile device. Always follow the
safety guidelines given by the manufacturer of cleaning and disinfectant
chemicals.
4. 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.
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).
6. WhenusingtheCompactensurethattheowheadconnectingtubeisnot
pinched or trapped as spirometry results may appear to be inverted.
7. Take care not to block the mouthpiece with tongue or teeth during testing. A
‘spitting’ action or cough will give false readings.

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Vitalograph COMPACT - Instructions for Use
8. Subject fatigue may occur during RMS or 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.
9. All values displayed are expressed as BTPS values.
10. Time zero is determined using the back-extrapolated method, from the
steepest part of the curve.
11. Do not expose the Compact to liquids.
12. TheCompactshouldnotbeusedinthepresenceofammableliquidsor
gases, dust, sand or any other chemical substances.
13. 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 daily, after cleaning or
disassembling the spirometer for any reason, after adjusting calibration or if
theowheadordevicehasbeendropped.
14. TakecarenottoblocktheMIPMEPpressureventontheowheadduring
testing. This pressure vent is intended to prevent glottal closure and prevent
the use of cheek muscles as indicated in the ATS/ERS Statement on
Respiratory Muscle Testing.
15. The following contraindications apply to MIP/MEP/SNIP testing:
a. Pathological conditions resulting in relatively large pressure swings in the
abdomen or thorax.
b. Aneurisms
c. Uncontrolled hypertension
d. Urinary incontinence
16. If subject cannot form a good seal on the BVF during MIP/MEP test then a
bite-onmouthpieceshouldbettedtotheBVF.
17. Service and repairs should be carried out only by the manufacturer or by
Service Agents approved by Vitalograph.
18. Maintenance must not be performed while the device is in use by a subject.
19. 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.
20. 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.
21. Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30

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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.
22. 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.
23. TheappliedpartistheFleischowhead.ThisalongwiththeBVF,arethe
contact points for the subject during a spirometry session.
24. Only use the Vitalograph Compact with the medically approved low voltage
power supply with which it is supplied. Attempted use with other power
sources may cause irreparable damage and invalidate the warranty. The
output from the power supply is 19 volts DC.
25. The device may be susceptible when exposed to high levels of
electrostaticdischarge.Torestorefunction,presstheOn/Offswitch.
26. To isolate the Model 6600 Compact from the mains supply, remove the 19V
Power Supply from the mains wall socket. Do not position the 19V Power
Supplywhereitisdiculttounplugfromthesocket.
27. Avoid exposure to known sources of EMI (electromagnetic interference)
such as diathermy, lithotripsy, electrocautery, RFID (Radio Frequency
Identication),andelectromagneticsecuritysystemssuchasanti-theft/
electronic article surveillance systems, metal detectors. Note that the
presence of RFID devices may not be obvious.
28. Loss or degraded performance due to EMI that exceeds the test levels in
immunitytesttablesbelowwillresultinafailedcalibrationverication.
ReferenceSpirotracIFUfordetailsoncompletingacalibrationverication
on the device. If interference is suspected or possible, move the device to a
newlocationandrepeatthecalibrationverication.

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Vitalograph COMPACT - Instructions for Use
3. Main Components of the Vitalograph Compact
1
23
4
5
6
7
8
9
10
11 12
13
14
15
Figure 1. Main components of the COMPACT
1 Power Supply
2 Stylus
3I/O Ports - 6 x USB, 2 x Ethernet, 2 x Display Port
Powerconnection,RMSport(MIP/MEP/SNIP)andowheadport
4 Flowhead
5Flowhead Connection Tubing
6 Bacterial Viral Filter (BVF)
7 Flowhead Carrier
8 Colour LCD and Touch Panel Display
9 Power Switch
10 MIP/MEP Pressure Vent
11 MIP/MEP Flowhead Connection tube
12 MIP/MEP Flowhead
13 SNIP Nasal Probe
14 SNIP Nasal Probe Adaptor
15 Adjustable Leg
16 WiFi dongle (not pictured)
17 USB key with Connect Software (not pictured)

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3.1. Features of the Vitalograph Compact
• Medical workstation running Vitalograph Spirotrac Software
• Spirometryowhead(FleischPneumotachograph)
• Respiratorymusclestrength(RMS)owheads(optional)
• Touch screen colour display
• Audio feedback
• Connectivity for devices integrated with Spirotrac software
• Automatic storage of all test data
• Networked database (optional)
• Sniff nasal inspiratory pressure (SNIP) measurement
• Adjustable leg to change viewing angle of display.
4. Setting Up the Vitalograph Compact
1. AttachtheowheadtotheVitalographCompactusingthesiliconetubing
(Flowhead Connection Tube). The tubing is keyed so that it may only be
inserted in the correct orientation.
2. Ifrequired,attachtheMIPorMEPowheadtotheVitalographCompact
by the tubing supplied. Ensure that the clear end of the tube is connected
to the RMS Connection porton the Compact, adjacent to the spirometry
connector. The white silicone tube on the other end of the tubing is attached
totheconnectorontheMIPorMEPowhead.
Note: The push in connector on the connection port should be pushed
 rmlyandsquarelyagainstthefaceoftheconnectorwhenconnecting/
 disconnectingthetubing.Connectotherendoftubingtotheowhead.
3. If required, attach the SNIP nasal probe adaptor to the RMS connection port
on the Compact. Fasten the SNIP nasal probe to the adaptor.
Note: The push in connector on the connection port should be pushed
rmlyandsquarelyagainstthefaceoftheconnectorwhenconnecting/
disconnecting the tubing.
4. Ifrequired,attachtheWidongle(16)intoanavailableUSBportonthe
back of the device (3) (see Figure 1).
5. The leg may be adjusted to change the viewing angle of the display.
6. 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.
Note: Only use the Compact with the purpose-built low voltage power
supply with which it is supplied.
7. Use the Launcher to open the Spirotrac application, add Ethernet, WiFi,
printers. Contact Technical Support for approved installation assistance.
8. For guidance using Spirotrac software on the Compact refer to the Spirotrac
Instructions For Use available on the device, in the ‘’i’ (information) option in
the menu on the left side of the Spirotrac application.
9. For guidance installing the Vitalograph Connect Software, please refer to
the Connect Instructions for Use on the USB Key. Connect will need to be

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Vitalograph COMPACT - Instructions for Use
installed on a separate networked PC/Network and NOT on the Compact
device.
10. To power down Compact close the Spirotrac session by pressing the power
button on the menu at the left side, this will automatically log-off the current
user and return to the Launcher. In the Launcher the power option is in the
menu on the left.
Note: The device may be powered down by pressing and holding the On/
Off button but this is only recommended if there is a malfunction.
Correct power-down is only achieved if Spirotrac is closed properly.
If the device has just been unpacked or transported, ensure that it is left sitting,
powered on and is at room temperature prior to testing for at least an hour before use.
4.1. Compact Communications
Figure 2. Compact communications/connectors
1,2 Display port x 2
3, 4 Ethernet x 2
5,6,7,8,9,10 USB x 6
Power
RMS ConnectorforMIP/MEPowheadsor
Reusable SNIP adaptor.
Connectorforowhead
5. Operating Instructions
1. The Vitalograph Compact works with Vitalograph Spirotrac software. Refer
to Spirotrac Instructions for Use (available on the device) for operating
instructions and details on:
• Entering Subject Data
• Conducting spirometry testing

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• Conducting testing with accessory or third party integrated devices
• Printing a Report
• CalibrationVerication
• Connect set-up for EMR Integration
2. Toentertext,touchrelevanteldonthescreenandusetheonscreen
keyboard to enter the details.
3. Use the Launcher to open the Spirotrac application, add Ethernet, WiFi,
printers. Contact Technical Support for approved installation assistance.
4. ToinstallandconguretheConnectfunctionalityseeVitalographConnectIFU.
Note: Connect Software (17) MUST be installed on an external PC/
Network and NOT on the Compact device.
6. Power Management
The Vitalograph Compact must be powered using the 19V low voltage Power
Supply unit supplied with the device.
The Power Supply unit should be checked regularly and replaced when necessary.
7. Cleaning & Hygiene
7.1. 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) and where required,
SNIP nasal probe, 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.
7.2. Inspection of the Vitalograph Compact
Fleisch Flowhead:
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 2019 guidelines1.
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

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Vitalograph COMPACT - Instructions for Use
1 Flowhead Complete
2 Flowhead End Cap
3 Flow Conditioning Mesh
4 Fleisch element Assembly
5 ‘O’ Rings
6Pressure Tapping
7 Flowhead Cone
1 MIP/MEP end cap
2 MIP/MEP one way valve
3 MIP/MEP cone
4 One-way valve hard plastic
housing
5 Soft silicone one-way valve
Figure 3: Fleisch Flowhead Assembly
MIP/MEP Flowhead:
Visual inspection is recommended on a routine basis. Unscrew the MIP/MEP
end cap from the cone. Remove the one-way valve from the cone and examine
it for damage. If damaged, discard and replace with a new part (Reference
Section 10. Consumables and Accessories). Carefully separate the hard plastic
housing from the soft silicone one-way valve, avoiding damage to the one-way
valve.
Figure 4: MIP/MEP Flowhead Assembly
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45

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Carefully re-assemble the silicone one-way valve with the hard plastic housing,
taking care not to damage the silicone one-way valve.
Note: It is important that the one-way valve is tted to the cone in the correct
orientation for the different MIP and MEP owheads. Refer to the images below
for the correct orientations. The owhead version is marked on the end cap.
Ensure the one-way valve is fully seated and centered into the groove on the
cone.
Figure 5: Orientation of one-way valve
Screw the MIP/MEP end cap to the cone. Ensure it is fully screwed home and
handtightened.Attachthewhiteendoftheowheadconnectiontubetothe
pressuretappingontheMIP/MEPowhead.Theclearendoftheowhead
connection tube is connected to the push in connector adjacent to the
spirometry connector on the Compact base.
TochecktheMIP/MEPowheadhasbeencorrectlyre-assembledattachaBVF
to the MIP/MEP Flowhead and test as follows:
1. MEPFlowhead:fullyinspirethoughtheowhead.Theone-wayvalveshould
open, and no resistance should be felt. Then attempt to expire. The one-way
valveshouldclose,andasignicantresistanceshouldbefelt.Theonlyair
escapingshouldbethroughtheMIP/MEPPressureVentontheowhead.
2. MIPFlowhead:fullyexpirethroughtheowhead.Theone-wayvalveshould
open, and no resistance should be felt. Then attempt to inspire. The one-
wayvalveshouldclose,andasignicantresistanceshouldbefelt.Theonly
airenteringshouldbethroughtheMIP/MEPPressureVentontheowhead.

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Vitalograph COMPACT - Instructions for Use
8. Fault Finding Guide
Problem Fault Symptoms:• Incorrect or no volume measurements
PossibleCauses:
(In probable order)
• Ensure tubing is connected correctly.
• Ensure that connectors are clear of
obstruction or dirt and are inserted fully.
• Ensure tubing is not kinked or squeezed.
Problem Fault Symptoms: • Test performed but does not show on screen
PossibleCauses:
(In probable order)
• Ensure tubing is connected correctly between
owheadanddevice(tubingiskeyedsowill
onlytproperlyinthecorrectorientation).
• Possible internal PCBA failure – turn off and
on the device, repeat test. If problem persists,
contact Support.
Problem Fault Symptoms:
• Communication error message appears
when entering the Test screen, the
Calibration Verication screen or the
Calibration Update screen
PossibleCauses:
(In probable order)
• Possible internal PCBA failure – turn off and
on the device, repeat test. If problem persists,
contact Support.
Problem Fault Symptoms: • Accuracy check variations > +/- 2.5%
PossibleCauses:
(In probable order)
• Recheck Calibration with reference to
CalibrationVericationsectioninthe
Spirotrac IFU.
• 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.
• Cold syringe – ensure syringe is in its test
environment for at least an hour before use.
• Internal tubing from pressure ports on device
is blocked – contact Support.
• Electronics failure – contact Support.
Problem Fault Symptoms:
• Test begins automatically
• Volume accumulates automatically without
the subject blowing
• Very small VC or FVC test displayed

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PossibleCauses:
(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.
Problem Fault Symptoms:
• Time and date are incorrect, or device will
not hold the time and date once it is powered
off.
PossibleCauses:
(In probable order)
• RTC may have reset – manually reset the time
and date. Power device off and on again to
check it is holding the time and date.
• Possible RTC battery failure – the coin cell
battery may need replacing, contact Support.
Problem Fault Symptoms: • Incorrect or no pressure measurements
during a MIP/MEP/SNIP test.
• Ensure tubing is connected correctly to the
MIP/MEPowheadandtotheMIP/MEP/
SNIP connection port on the Compact.
• Ensure that the connectors are clear of
obstruction or dirt and that they are inserted
fully.
• Ensure the tubing is not kinked or squeezed.
• Ensurethatthecorrectowheadisbeing
used.i.e.aMIPowheadforaMIPtestand
aMEPowheadforaMEPtest.SNIPtest
requires a Nasal probe, ensure that it is the
correct size.
• Checkthattheone-wayvalveisttedin
the correct orientation to the MIP and MEP
owhead(ReferenceFigure5).Testthe
owheadfollowinginstructionsoutlinedin
Section 7.2.
• Check the condition of the one-way valve. If
damaged, replace with new part.
8.1. Software Check
Information about Spirotrac, and the IFU, is available in the ‘’i’ (information)
option in the menu on the left side of the Spirotrac application. This information
may be used when contacting Vitalograph or a service agent with queries.

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8.2. Product Useful Life Checks
To ascertain whether the device has exceeded its useful life Vitalograph
recommendscheckingtheowheadandtheRealTimeClockbattery.
Theowheadmaybecheckedwiththerecommendeddailycalibration
verication,tobecompletedbytheclinician/healthcareprofessional,and
during the periodic inspection of the device. Reference the calibration
vericationsectionintheSpirotracInstructionsforUse,fordetailsonhowto
checkthedeviceowhead.
The clock may reset to a default time and date on power down if the 3V coin
cell battery has depleted. Vitalograph recommend changing the battery during
routine service every 5 years.
9. 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 Authorised Representative and the Regulatory
Authorities of the country. Refer to the Vitalograph contact information at the
start of this manual.
It is recommended the coin cell battery powering the RTC is changed every 5
years by a trained Vitalograph service agent or the manufacturer.
10. Consumables and Accessories
Type Cat. No Description
Consumables 28572 Eco BVF and Disposable Nose Clip (80)
28370 28350 BV Filter + 20243 Nose Clips - box of 50
32956 SNIP Nasal Probe (pack of 30, 10 x small, 10 x
medium, 10 x large) 
Accessories 36020 2040 Precision Syringe 3-L
67181 COMPACT 19V Power Supply
77933 Flow Conditioning Mesh (10)
77934 Flowhead Complete
77939 Flowhead Cone
77938 Flowhead End Cap
79192 Flowhead Connection Tube
2120013 O-Ring (15)

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77652 MIP MEP Flowheads
77651 MIP MEP Connection Tube
77653 Silicone One-way Valve (Pack of 2)
77973 SNIP Nasal Probe Adaptor
67242 Compact Stylus
11. 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.
12. Explanation of Symbols
Symbol Description
Type B equipment
Class II
VA Power rating
Voltage DC
Instructions for Use; operating instructions
Manufacturer
Year of Manufacture (Date format YYYY-MM-DD)
USB connector
Ethernet connector
Flowhead connector

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RMS MIP/MEP/SNIP connector
On/Off
The device must be taken to separate collection at the product
end-of-life. Do not dispose of these products as unsorted
municipal waste
Non sterile
Recycle
Keep dry
Do not re-use
QR code - matrix bar code. All information in the bar code is
included in the text under it
MR Unsafe – Do not use this device in an MRI environment.
13. 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, clinics 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, 12-lead ECG and Audiometry testing.

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14. Technical Specication
Product Vitalograph Compact
Model 6600
Flow Detection Principal Fleisch type pneumotachograph
Volume detection Flow integration sampling @ 100Hz
Volume Accuracy ±2.5%or±0.05L
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 ±10%or 0.3 L/s
Back pressure of Fleisch
Flowhead
Less than 0.1kPa/L/sec at 14L/sec
Operating Pressure RMS +/- 300cmH20
Pressure Accuracy RMS +/-3%
Pressure Resolution RMS 1 cmH20
Operating temperature
range
ISO 26782:2009 Guidelines: 17–35ºC
Design limits: 10–40ºC
Operating humidity range 30%–75%
Operating ambient pressure
range
850hPa–1060hPa
Performance standards
the Vitalograph COMPACT
meets or exceeds
ISO23747:2015,ISO267822009,ATS/ERS2019
Safety standard EN60601-1:2006 + A1:2013 + A2:2021 + A2:2021
EMC standard EN 60601-1-2:2015 + A1:2021
QA/GMP standards EN ISO 13485:2016, FDA 21 CFR 820, CMDR
SOR/98-282 & Japan’s PMD Act
Dimensions 296 x 261 x 108 mm
Weight 3 kg net
Communications USBx6,Ethernetx2,Wi
Power Supply 19V DC Power Supply
Operating System Windows 10 Embedded
Processor Intel Quad Core Processor
RAM 4GB
Screen 12.1” LCD 1280*800 pixel with capacitive touch
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Notes:
• All values displayed are expressed as BTPS values.
• Take care not to block the cone with the tongue or teeth. A ‘spitting’ action
or coughing will give false readings.
• Time zero is determined using the back-extrapolated method, from the
steepestpartofthecurve.Theoperatingconditionsspeciedapplytothe
device plus accessories.
• TheowheadandBVFareclassiedastypeBappliedparts.Thedevice
• body or other accessories are not applied parts. An applied part is a part of
the equipment, that in normal use necessarilycomes into physical contact
with the subject for equipment or system toperform its function
15. 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 Compact is intended for use by trained healthcare
professionals in a variety of professional healthcare environments, e.g. primary
care, hospitals, clinics and mobile clinics including occupational health settings
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 should assure that it is not
used in such an environment.
The Model 6600 Compact has been tested in accordance with:
EN60601-1:2006 + A1:2013 + A2:2021 - Medical electrical equipment. General
requirements for basic safety and essential performance
EN 60601-1-2:2015 + A1:2021 - Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.

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EN 60601-1-2:2015 + A1:2021 - 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 A
The Model 6600 Compact is suitable for use
in professional environments only, such as
hospitals, clinics.
This device is not suitable for use in home/
residential environments. 
EN 60601-1-2:2015 + A1:2021 -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
The device may reset/turn off when
exposed to higher levels of ESD. To
recover press the On/Off button.
Proximity
eldsfrom
RF wireless
9to28V/m
385to5785MHz
As per Table 9
EN60601-1-2

9to28V/m
385to5785MHz
AsperTable9EN60601-1-2

Radiated RF
EN 61000-4-3
3 V/m (professional
healthcare)
80MHzto2.7GHz
80%amplitude
modulatedat1kHz
3V/m(professionalhealthcare)
80MHzto2.7GHz
80%amplitudemodulatedat1kHz
Electrical fast
transient/burst
IEC 61000-4-4
±0.5, ±1 & ±2kV
100kHz ±0.5, ±1 & ±2kV 100kHz