IMT Analytics FlowAnalyser PF-300 PRO User manual

User Manual
FlowAnalyser PRO

IMT Analytics AG
Gewerbestrasse 8
9470 Buchs (SG)
Switzerland
www.imtanalytics.com

Table of contents
1 Introduction 5
2 Intended use 6
3 Safety instructions 8
3.1 Representation of hazards, cautions and notes 8
3.2 Personnel 8
3.3 Responsibility and guarantee 8
3.4 Service life 8
4 Specifications 9
4.1 Measurement parameters 9
4.2 Gas standards for flow and volume measurement 13
4.3 Power supply 14
4.4 Battery operation 14
4.5 Directives and approvals 15
4.6 Device labels and symbols 15
4.7 PC minimum requirements 16
5 Start-up 17
5.1 Individual parts in the packaging 17
5.2 Power supply 18
5.3 Mechanical connectors 18
5.4 Electrical interfaces 22
6 Operation 25
6.1 Switching the device on and off 25
6.2 The Start screen 25
6.3 Direct Access Controls (DAC) 25
6.4 User control gestures 26
6.5 Main menu 27
6.6 Settings 27
6.7 Numerical readings 29
6.8 Graphical readings 29
6.9 Software update 30
6.10 Applications 31
6.11 Gas type and standards 32
6.12 Filter 33
7 Calibration 34
7.1 Zero point 34
7.2 Oxygen (O2) calibration 35
8 MultiGasAnalyser OR-703 36
8.1 Description 36
8.2 Usage 36
8.3 Warning 36
8.4 Principle 37
8.5 Connection 37
8.6 LED signal 37
8.7 OR sensor calibration 38
8.8 Servicing and care 38
8.9 Technical specifications 39

IMT Analytics AG
9 Measuring ventilation parameters 40
9.1 General 40
9.2 Connecting to the ventilator 41
9.3 Standard trigger values 42
9.4 Base flow 42
9.5 Finding the correct trigger values 43
9.6 Special cases 45
10 Servicing and maintenance 47
10.1 Guidelines for servicing and care 47
10.2 Notes about changing parts 47
10.3 Preventive cleaning and servicing routines 47
10.4 Contact 49
11 Accessories and spare parts 50
11.1 Ordering address 50
11.2 Spare parts 50
12 Disposal 51
13 Appendix 52
13.1 Abbreviations and glossary 52
13.2 Measurement parameters and units 54
13.3 Index 56

Introduction
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IMT Analytics AG
Validity
This documentation is valid for the product with the designation:
• FlowAnalyser PF-300 PRO, REF 700.300.000
• MultiGasAnalyser OR-703, REF 500.041.000
You will find the name FlowAnalyser PRO on the rating plate on the side of the device.
Software and firmware version
This documentation applies to the following versions:
FlowAnalyser PRO firmware – version 4.16.000
In the case of older or newer versions there may be minor discrepancies in relation
to this User Manual.
Designations used in this User Manual
Buttons and indicators on the display.
Buttons such as Power and indicators on the display such as Change Settings are
printed in boldface italics.
References to pages and sections
For references to pages and references, e.g. (4.1.6 Physical data), the symbol
(XY) is used.
Version information
Issue date of this User Manual: Release 04, 2022-04
Subject to technical modifications without notice.
1 Introduction

Intended use
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IMT Analytics AG
This product is intended for testing and calibration purposes on medical devices
or systems that generate gas flows or gas pressures. That includes ventilators and
anaesthetic machines. The user of the device has received training on how to use
medical equipment and can perform repairs, maintenance and servicing on medical
devices. The device can be used in hospitals, in clinics, at device manufacturers or at
independent service companies that perform repairs or servicing on medical devices.
FlowAnalyser PRO is intended for use in a laboratory environment. The device must
be placed in a position that the display is readable by the user without impairment. It
may only be used outside the nursing sector. It must not be used directly on patients
or devices that are connected to patients. The measuring instrument FlowAnalyser
PRO is intended for over-the-counter sale.
FlowAnalyser PRO is the solution for measurements in the following areas:
• Flow (-300 – 300 L/min)
• Ultra-low flow (-1–1 L/min)
• Volume
• High differential pressure (-250 – 250 mbar)
• Low differential pressure (-10 – 10 mbar)
• High pressure/vacuum (-1 – 10 bar)
• Ambient pressure (500 –1240 mbar)
• Oxygen (0 – 100 vol %)
• Temperature (0 – 50 °C)
• Humidity (0 – 100 %)
• Channel pressure (-50 – 160 mbar)
In addition, variousventilation parameters can be measured:
• Inspiratory tidal volume, expiratory tidal volume
• Inspiratory minute volume, expiratory minute volume
• Volumen
• Post-Inspiratory Pause %Tp
• Breath Rate
• I:E
• Inspiratory time, expiratory time
• Inspiratory hold time, expiratory hold time
• Ppeak
• Pmean
• Pplateau
• PEEP
• PF Insp (inspiratory peak flow)
• PF Exp (expiratory peak flow)
• Ti/Tcyc
• Cstat
2 Intended use

Intended use
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FlowAnalyser PRO is a measuring instrument for checking and cali-
brating ventilators and anaesthetic machines. It must not be used for
patient monitoring. During patient treatment using the ventilator, it is
not permitted to connect to FlowAnalyser PRO.
Using the device for patient monitoring, the following contra indications can occure:
• contamination of the device
• contamination of the patients lung
• loss of ventilation performance
• increase of dead value
This product is intended to be used at elevations of up to 3000 MASL in buildings.

8
Safety instructions
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IMT Analytics AG
This User Manual uses the representation below to specifically draw attention to
residual risksduring intended use andemphasise important technical requirements.
Information and/or instructions and prohibitions shall be observed to
prevent damage of any kind.
Work on and with FlowAnalyser PROmay only be performed by
persons whohave undergone appropriate technical training andhave
the necessary experience.
Themanufacturer accepts no responsibilityor guarantee and willbe exempt fromli-
ability claims accordinglyif theoperatoror any third parties:
• fail to use the device in accordance with its intended use
• disregard the specifications
• tamper with the device in any way (conversions, modifications, etc.)
• operate the device with accessories that are not listed in theassociatedsets
of product documentation.
Although the devicemeets high quality and safety standards andit
has beenconstructed and tested according to the current state
of the art,it is not possible to rule outthe risk of injuries withseri-
ousconsequencesif the device is not used in compliance with the
intended use (used improperly) or is misused. Therefore, please read
through this User Manual carefully and keep this documentation in a
readily accessible place close to your device.
If you have received the device with damaged packaging, please contact the office
listed below.
Customer service
Email: [email protected]
If you are aware of an incident, please contact the office listed below.
Technical support
Tel: [phone]
Email: [email protected]
Themaximum service life of the devicehas been specified as 10(ten)years,provided
it is handled properly in accordance with this User Manual.
3.1 Representation of hazards,
cautions and notes
3 Safety instructions
3.2 Personnel
3.3 Responsibility and guarantee
3.4 Service life

Specifications
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4.1.1 Measuring instrument values1
Flow Range
Accuracy
-300 – 300 L/min***
± 1.65 %* or ± 0.04 L/min
(for 10 – 40° C)**
Ultra-low flow Range
Accuracy
-1 – 1 L/min***
± 1.65 %* or ± 0.01 L/min
(for 10 – 40° C)**
Volume Range
Accuracy
0 – 1000 L
± 1.75 %* or ± 0.10 mL
Pressure (at flow) Range
Accuracy
-50 – 160 mbar
± 0.5 %* or ± 0.1 mbar**
High differential pressure Range
Accuracy
-250 – 250 mbar
± 0.5 %* or ± 0.1 mbar**
Low differential pressure Range
Accuracy
-10 – 10 mbar
± 1 %* or ± 0.01 mbar**
High pressure and
vacuum
Range
Accuracy
-1 – 10 bar
± 1 %* or ± 7 mbar**
Ambient pressure Range
Accuracy
500 – 1240 mbar
± 1 %* or ± 5 mbar**
Oxygen Range
Accuracy
0 – 100 vol %
± 1 vol %**
Temperature Range
Accuracy
0 – 50 °C
± 1.75 %* or ± 0.5 °C**
Humidity Range
Accuracy
0 – 100 % RH***
± 3 % RH** from 10 % RH to 80% RH
± 5 % RH** for <10˚% RH and > 80% RH
1Standard litres per minute (converted to STP conditions of 21.1°C and 1013 mbar)
* Tolerance related to the measured value
** Ablsoute tolerance, with steady air flow
*** Non-condensing
4 Specifications
4.1 Measurement parameters

Specifications
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4.1.2 Ventilation parameters
Vti, Vte Tidal volume of inspiration
and expiration
Range
Accuracy
0 – 60 L
± 1.75 %* or ± 0.10 mL
Vi, Ve Minute volume of
inspiration and expiration
Range
Accuracy
0 – 300 L/min
± 1.75 %* or ± 5 ml/min
Ti Inspiratory time Range
Accuracy
0.01 – 60 s
± 0.01 s
Te Expiratory time Range
Accuracy
0.01 – 90 s
± 0.01 s
Ti/Tcyc Ratio of inspiratory time to
time of a respiratory cycle
Range
Accuracy
0 – 100 %
± 5 %*
Ppeak Peak inspiratory pressure Range
Accuracy
0 – 160 mbar
± 0.75%* or ± 0.10 mbar**
Pmean Mean airway pressure Range
Accuracy
0 – 160 mbar
± 0.75%* or ± 0.10 mbar**
I:E Inspiratory/expiratory time
ratio
Range
Accuracy
1:300 – 300:1
± 2 %*
PEEP Positive end-expiratory
pressure
Range
Accuracy
0 – 160 mbar
± 0.75%* or ± 0.10 mbar**
Rate Ventilation rate Range
Accuracy
0 – 2000 bpm
± 1.0 %** or ± 1 bpm
PFInsp Peak flow during
Inspiration
Range
Accuracy
-300 – 300 L/min
± 1.65 %* or ± 0.04 L/min**
PFExp Peak flow during
Expiration
Range
Accuracy
-300 – 300 L/min
± 1.65 %* or ± 0.04 L/min**
Cstat Static lung compliance Range
Accuracy
0 – 1000 mL/mbar
± 3%* or ± 0.01 mL/mbar**
Pplateau Inspiratory pause pressure Range
Accuracy
0 – 160 mbar
± 0.75%* or ± 0.10 mbar**
%TP Post-Inspiratory Pause
“%TP” (=Inspiratory hold
time/Inspiratory time)
Range
Accuracy
0 – 100 %TP
± 0.1 %TP
TiHold Insp. hold time Range
Accuracy
0 – 60 s
± 0.01 s
TeHold Exp. hold time Range
Accuracy
0 – 90 s
± 0.01 s
* Tolerance related to the measured value
** Ablsoute tolerance, with steady air flow

Specifications
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4.1.3 Principle of flow measurement
Flow in the flow channel is determinedbydifferential pressure measurement. To build
up differential pressure, a plastic screen is used to provide flow resistance.
ƞ: dynamic viscosity of the gas [Pa ∙s]
ρ: gas density [kg/m3]
c1, c2: device-specific constants (channel geometry)
Dynamic viscosity
Theviscosity of a medium is its resistance tothe flow and shear of the current. Vis-
cosity is extremely dependent on temperature. Theviscosity of a medium isslightly
dependent on the pressure andmoisture content of the medium.
Density
Density is the unit for the mass per unit volume of the medium. Density is very de-
pendent on pressure and temperature.
The impact of ambient conditions is hence the reason why flow is occasionally con-
verted to standard conditions.
(4.2 Gas standards for flow and volume measurement)
4.1.4 Special functions
Automatic battery operation in the event of a power failure
4.1.5 Communication interfaces
USB, RS-232 port for firmware download, remote control functions and connection
to MultiGasAnalyser OR-703 (optional), trigger input (digital) for external trigger.
4.1.6 Physical data
Weight: 3.2 kg
Size (l × w × h): 312 × 233 × 130 mm
Gas types: Air, O2, N2O, He, N2, CO2and
mixtures: Air/O2, N2O/O2, He/O2

Specifications
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4.1.7 Calibration by user
Offset calibration of the pressure and flow measurements. Calibration of the oxygen
sensor.
4.1.8 Operating data
Operating Humidity: 10 – 95 % RH (non-condensing)
Operation Temperature: 15 – 40 °C (59 – 104 °F)
Operating ambient pressure: 540 –1100 hPa
Storage ambient pressure: 540 –1100 hPa
Storage and transport conditions: -10 –60 °C (14–140 °F)
5 – 95 % RH (non-condensing)
Keep dry und keep away from sunlight.
IP classification: IP21
Installation categorie: Class II

Specifications
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IMT Analytics AG
FlowAnalyser PRO converts the flow and volume readings measured in the device
to match the conditions of the standard selected. The following gas standards are
supported by FlowAnalyser PRO:
Gas standard Temperature Pressure Relative
humidity
Ambient Temperature and
Pressure
ATP Current gas
temperature
Current
Ambient pressure
Current
gas humidity
Ambient Temperature and
Pressure Dry
ATPD Current gas
temperature
Current
Ambient pressure
0 %
Ambient Temperature and
Pressure Saturated
ATPS Current gas
temperature
Current
Ambient pressure
100 %
Ambient Pressure at 21°C AP21 21.0 °C (70 °F) Current
Ambient pressure
Current
gas humidity
Standard Temperature and
Pressure at 0 °C
STPD0 0.0 °C 1013.25 mbar
(760 mmHg)
0 %
Standard Temperature and
Pressure at 20 °C
STPD20 20.0 °C 1013.25 mbar
(760 mmHg)
0 %
Standard Temperature and
Pressure at 21°C
STPD21 21.0 °C 1013.25 mbar
(760 mmHg)
0 %
23 °C/1013 mbar 23/1013 23 °C (73.4 °F) 1013.25 mbar
(760mmHg)
0 %
Standard Conditions USA STP 21.0 °C (70 °F) 1013.25 mbar
(760 mmHg)
0%
Standard Conditions USA
Humid
STPH 21.0 °C (70 °F) 1013.25 mbar
(760 mmHg)
Current
gas humidity
Body Temperature and
Pressure Saturated
BTPS 37 °C (99 °F) Current ambient
pressure and
channel pressure
(Flow)
100 %
Body Temperature and
(Ambient) Pressure Sat-
urated according to ISO
80601-2-12:2011
BTPS-A 37 °C (99 °F) Current
ambient pressure
100 %
Body Temperature and
Pressure Dry
BTPD 37 °C (99 °F) Current ambient
pressure and
channel pressure
(Flow)
0 %
Body Temperature and
(Ambient) Pressure Dry
BTPD-A 37 °C (99 °F) Current
ambient pressure
0 %
Standard condition
according to DIN 1343
0/1013 0°C (32 °F) 1013.25 mbar
(760 mmHg)
0 %
Standard condition
according to ISO 1-1975
(DIN 102)
20/981 20 °C (68 °F) 981 mbar
(736 mmHg)
0 %
Please always use standard condition STP for ultra-low flow meas-
urements.
4.2 Gas standards for flow and
volume measurement

Specifications
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Gas standard Temperature Pressure Relative
humidity
API Standard Conditions 15/1013 15 °C (60 °F) 1013.25 mbar
(14.7 psia)
0 %
Cummings Standard 25/991 25 °C (77 °F) 991 mbar
(500 ft altitude)
0 %
20 °C/1013 mbar 20/1013 20 °C (68 °F) 1013.25 mbar
(760 mmHg)
0 %
Normal Temperature and
Pressure
NTPD 20.0 °C (68 °F) 1013.25 mbar
(760mmHg)
0 %
Normal Temperature and
Pressure, Saturated
NTPS 20.0 °C (68 °F) 1013.25 mbar
(760mmHg)
100 %
Ambient Pressure at 25 °C AP25 25.0 °C (77 °F) Current Ambient
pressure
Current gas
humidity
In this User manual, the unit L/min is based on ambient conditions of
0 °C and 1013 mbar (DIN 1343).
Please refer to Appendix B: Measurement parameters and units.
Here, you will also find the conversion factors for the units of meas-
urement.
Input voltage of the power supply unit: 100 –240 VAC, 50– 60 Hz, 2.0 A
Output voltage of the power supply unit: 24 VDC, 2.7 A
PF-300 PRO input voltage: 24 VDC, 2.5 A
Power supply protection class: Class I
Only use the power supply unit and cable provided!
Operating time in battery operation: 16 hours
Operating time in battery operation
with MultiGasAnalyser: 13 hours
Charging the battery
A complete charging process takes 8h. The service life of the battery is extended if
the battery is charged completely only after a prompt by the device.
Thedevice indicates visually and audiblywhen the battery must be
charged. Please do not store the battery in depleted state.
Caution:depletion can damage the battery beyond repair!
4.3 Power supply
4.4 Battery operation

Specifications
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• IEC 61010-1
• IEC 61326-1
• CAN/CSA-C22.2 No. 61010-1-12
• UL 61010-1 3rd Edition
The device is classified as Pollution Degree 2.
The device is classified as Overvoltage Category II.
The device is not intended for use outside a building.
The following labels and symbols can be found on FlowAnalyser PRO and its pack-
aging:
Symbol Description
Stand-by
Alternating current
Class II equipment
For indoor use only
Direct current
Ethernet network connector
USB Port to connect an USB Stick
Serial interface
Port to communicate with a computer
Battery
Conforms to CE Directives and Regulations
Safety Mark for North America for PF-300 PRO
Safety Mark for North America for Power Supply
Manufacturer
4.5 Directives and approvals
4.6 Device labels and symbols

Specifications
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Symbol Description
The operating instructions should be considered when operat-
ing the device
Caution is necessary when operating the device
Do not dispose with household waste
Serial Number
Reference Number
Temperature range for transport and storage
Humidity range for transport and storage
Atmospheric pressure for storage and transport
Keep dry
Protect from sunlight
UDI Data Matrix
Code (e.g.):
Unique device identifier
(01) GTIN-No.
(10) Batch Code
(11) Production Date
(21) Serial No.
IP21 Protection class according to standard
Trigger IN Trigger interface, maximum 24 V, 60 mA
Intel® Pentium® 4 2.4 GHz
(Intel® Core TM2 Duo recommended)
Microsoft® Windows® XP, Vista, 7, 8 (32 bit / 64 bit)
Microsoft® .NET Framework 3.5 or higher
128 MB RAM (512 MB recommended)
160 MB storage space on hard disk (full installation) CD-ROM drive
Monitor 800 × 600 (1024 × 768 recommended)
4.7 PC minimum requirements

17
Start-up
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IMT Analytics AG
Picture Description
FlowAnalyser PRO
Power supply
(Order No. 700.355.000)
USB cable
Calibration certificate
Filter
Adapter set
5.1 Individual parts in the
packaging
5 Start-up

Start-up
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The power supply socket is located at the back of FlowAnalyser PRO.
The device can be disconnected from the mains using the power
cord. The cord should therefore be easily accessible.
5.2.1 Supply voltage
The mains voltage of the power supply unit included is 100 –240 VAC at 50– 60 Hz.
Before switching on, make sure the operating voltage of the power
supply unit is compatible with the local mains voltage. You will find
this information on the rating plate on the back of the power supply
unit.
Only operate FlowAnalyser PRO with the original power supply unit
included!
5.3.1 Filter
To protect the device against soiling due to contaminants and particles in the air,
the filter included must be used for flow measurement. Connect the filter on the flow
channel port between the tube and the device (9.2. Connecting to the ventilator).
Particles of dirt in the air can clog the measuring system and thus
lead to incorrect measurements. The filter must be checked regularly
(10.3 Preventive cleaning and servicing routines).
5.2 Power supply
5.3 Mechanical connectors

Start-up
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5.3.2 Adapter set
The adapters enclosed can be used to connect the test specimen to FlowAnalyser
PRO. Minimising dead volume and differences in the diameter of the flow stream
helps to increase the accuracy of measurement. When using the Ultra-Low Flow
channel, the positive connector of the differential pressure sensor is used for pres-
sure measurements. The relevant ports can be connected to one another using the
supplied tee and connecting tube.
5.3.3 Flow channel
The flow channel can be used to perform gas flow measurements from -300 to 300 L/
min. Additionally, the channel includes sensors for pressure, temperature, humidity
and oxygen concentration.
Measuring range: -300 – 300 L/min
Accuracy: ± 1.65 % of reading or ± 0.04 L/min
If work is being performed at a relatively high level of air humidity,
care must be taken to ensure that no condensation forms in the
device. Water can damage the sensors beyond repair!

Start-up
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5.3.4 Ultra-low flow
The ultra-low flow measurement can be used to measure very low gas flows within
a range of -1 to 1 L/min
Measuring range: -1 – 1 L/min
Accuracy: ± 1.65 % of reading or ± 0.01 L/min
5.3.5 Low differential pressure
The low differential pressure connectors can be used for differential pressure meas-
urements with low pressures.
Measuring range: -10 –10 mbar
Accuracy: ± 1 % of reading or ± 0.01 mbar