Rigel Medical FloTest User manual

rigelmedical.com
FloTest
USER MANUAL

RIGEL MEDICAL FloTest MANUAL
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Table of contents
1 Introduction 2
2 Intended use 3
3 Safety instructions 4
3.1 Representation of hazards, cautions and notes 4
3.2 Personnel 4
3.3 Responsibility and guarantee 4
3.4 Service life 5
4 Specifications 6
4.1 Measurement parameters 6
4.2 Principle of flow measurement 7
4.3 Special functions 7
4.4 Communication interfaces 7
4.5 Physical data 7
4.6 Calibration by user 8
4.7 Operating data 8
4.8 Gas standards for flow and volume measurement 9
4.9 Power supply 9
4.10 Battery operation 10
4.11 Directives and approvals 10
4.12 Device labels and symbols 11
4.13 Feature Set 12
5 Start-up 13
5.1 Individual parts in the packaging 13
5.2 Power supply 14
5.3 Mechanical connectors 15
5.4 Electrical interfaces 16
6 Operation 18
6.1 Switching the device on and off 18
6.2 Acoustic feedback 18
6.3 User control gestures 18
6.4 Screens 20
6.5 Menu 24
7 Measuring volume 37
7.1 General principal 37
7.2 Finding the correct trigger values 37
8 Servicing and care 38
8.1 Guidelines for servicing and care 38
8.2 Notes about changing parts 38
8.3 Preventive cleaning and servicing routines 38
8.4 Cleaning 39
8.5 Trouble shooting 39
8.6 Contact 41

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1 Introduction
Validity
This documentation is valid for the product: Rigel FloTest
You will find the name FloTest on the label at the back of your device.
Software and firmware version
This documentation applies to the following versions:
FloTest firmware –Version 1.2.000
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 such as Power and indicators on the display such as Settings are printed in boldface italics.
References to pages and sections
For references to pages and references, e.g. (4.5Physical data), the symbol (XY) is used.
Version information
Issue date of this User Manual: Release 02, 2023-03
Subject to technical modifications without notice.

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2
2 Intended use
This product is intended for testing and calibration purposes of medical –or other devices or systems that generate Air / O2/
N2gas flows and / or gas pressures.
The device is intended for users who are trained in the use of measuring devices and who can carry out tests, repairs,
calibrations, maintenance, and service work on medical or other devices. No dedicated training on this specific device is
required.
The device can be used in:
• Hospital service departments
• Clinics
• Medical and non-medical devices manufacturing facilities
• Workshop / testing / laboratory facilities of independent service companies performing service and repair for
medical and non-medical devices
FloTest is intended for use in an indoor test laboratory environment. 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 FloTest is intended for over-the-counter sale.
FloTest is the solution for measurements in the following areas:
• Flow (±300 L/min)
• Volume (0L –500000 L)
• Absolute pressure in the Flow channel (0.5 –2 bar)
• Temperature in the Flow channel (-10 –50 °C)
This product is intended to be used at elevations of up to 5000 m operation altitude in buildings.
FloTest is a measuring instrument for testing and calibrating
purpose on medical and non-medical devices or systems. It must not be
used for patient monitoring. FloTest must not be used directly on patients
or devices that are connected to patients.

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3 Safety instructions
3.1 Representationof hazards,
cautions and notes
This User Manual uses the representation below to specifically draw attention to residual risks
during intended use and emphasize important technical requirements.
3.2 Personnel
3.3 Responsibility and
guarantee
The manufacturer accepts no responsibility or guarantee and will be exempt from liability
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
Information and/or instructions and prohibitions to prevent damage of any
kind.
Report any serious incident that has occurred in relation to the medical
device to the manufacturer (8.6.2 Technical support) and the authority having
jurisdiction in their locale
The device has user replaceable parts (8.3 Preventive cleaning and servicing
routines)
Negligence of warning and errormessages can lead to damage of the device
The device including the measurement channel shall not be exposed to high
levelof volatileorganiccompounds (VOC).Doing so may lead to permanent
offset of the humidity sensor.
Only use original packaging in good condition for transport or storage
The device must not be placed in a pressure chamber
The device is not intended to measure flammable or combustible gases
The device is not intended to measure liquids
The device must not be connected to a telecom network
The device must only be connected to approved equipment with CE, CSA,
UL or other equivalent safety mark to ensure double insulation
Work on and with FloTest may only be performed by persons who have
undergone appropriate general technical training and have the necessary
experience.

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3.4 Service life The typical service life of the device is specified as 10 (ten) years, provided it is handled
properly in accordance with this User Manual.
Although the device meets high quality and safety standards and 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 serious consequences if the
device is not used in compliance with the intended use (improperly) or is
misused. Therefore, please read this User Manual carefully and keep this
documentation in a readily accessible place close to your device.

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4 Specifications
4.1 Measurement
parameters
Accuracy valid
• between 10°C and 30°C (channel temperature)
• between 950 hPa and 1250 hPa
• zero offset calibration performed after warm-up
• for measurements performed within 4 h after last zero offset calibration at same ambient
conditions
1 Flow accuracy specified is valid under the above-mentionedgeneral conditions and for an air flow in positive flow
direction.
• Add 0.05 % of reading per 1°C outside the range of 10°C to 30°C (channel temperature)
• Add 0.005 % of reading per 10 hPa above 1250 hPa
• Add 0.01 % of reading per 10 hPa below 950 hPa
• Add 0.05 % of reading per 10 % oxygen concentration above 21 %
• Add 0.2 % of reading for negative flow direction
Flow accuracy stated with gas (channel) temperature and ambient temperature within 10°C of each other. Add
0.05 % of reading per 1°C above 10°C temperature difference.
2At flow rate ≥50 L/min, screen brightness ≤30 %, battery not charging
*Non-condensing
Parameter
Value
Flow1
Range
±300 L/min
(4.13 Feature Set)
Accuracy
FloTest:
±1.9 % or ±0.05 L/min
Volume
Range Accuracy
0 L –500000 L
±4 % or ± 1 mL
Absolute pressure in the
Flow channel
Range Accuracy
0.5 –2 bar
±10 mbar
Temperature2
Range
-10 –50 °C
Accuracy
±1 °C
All flow and volume specifications are based on STP gas standard at
21.1 °C and 1013.25 mbar.
For all specifications with absolute and relative tolerances, the greater value
applies (for example: ±1.9 % of reading or ±0.05 L/min absolute, whichever
is greater).

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4.2 Principleof flow
measurement
4.3 Special function
4.4 Communication
interfaces
4.5 Physical data
Flow in the flow channel is determined by differential pressure measurement. To build up
differential pressure Δp, a measuring disc is used to provide flow resistance. For flow rates > 50
L/min the differential pressure Δp2 is used. For lower flows, the Flow- Meter uses Δp1 to
improve the accuracy at lower flow rates.
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.
Viscosity 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 dependent on
pressure and temperature.
The impact of ambient conditions is hence the reason why flow is occasionally convertedto standard
conditions.
(4.8 Gas standards for flow and volume measurement)
Automatic battery operation in the event of a power failure.
• USB-A: for data recording and software updates
• USB-C: no communication, used only for charging
• RJ-10 (serial port) to stream measurement values and set up the device
Weight: 350 g
Size (l × w × h): 200 × 80 × 60 mm
Gas types: Air, O2, N2 and mixtures: Air/O2

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4.6 Calibration by
user
4.7 Operating data
Offset calibration of the pressure and flow sensors (6.5.8 Zero offset calibration).
Degree of protection, against water and dust, according to IEC 60529: IP 20
The FloTest has 3 different modes:
• Battery operated
• Mains supplied / battery charging
• Switched off / storage
Please note the different ambient condition for the different modes. The allowed conditions for the Flow
channel and the device enclosure are different.
Battery operated
Mains operated
Environment conditions
Allowed range
Temperature (flow channel / enclosure)
5 –40 °C (41 –104 °F)
Air humidity (enclosure)
10 % –90 % RH*
Absolute pressure in flow channel
50 kPa –200 kPa
Atmospheric pressure
54 kPa –120 kPa
Environment conditions
Allowed range
Temperature (flow channel / enclosure)
-10 –50 °C (14 –122 °F)
Air humidity (enclosure)
10 % –90 % RH*
Absolute pressure in flow channel
50 kPa –200 kPa
Atmospheric pressure
54 kPa –120 kPa

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Switched off / storage
* Non-condensing
4.8 Gas standards for flow
and volume
measurement
4.9 Power supply
FloTest 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 FloTest:
Gas standard
Temperature
Pressure
Relative humidity
Ambient Temperature and
Pressure
ATP
Current gas
temperature
Current
ambient pressure
Current
gas humidity
Channel Temperature and
Pressure
CTP
Current gas
temperature
Current
channel pressure
Current
gas humidity
Standard Conditions USA
STP
21.1 °C (70 °F)
1013.25 mbar
(760 mmHg)
0 %
Body Temperature and
(Ambient) Pressure
Saturated according to ISO
80601-2-12:2011
BTPS-A
37 °C (99 °F)
Current
ambient pressure
100 %
Input voltage of the power supply: 100 –240 VAC (±10 %), 50 –60 Hz, 0.6 A Output voltage
of the power supply: 5 VDC, 3 .0 A
FloTest input voltage: 5 VDC, 2.5 A
TheoriginalpowersupplyfromIMTAnalyticsmustbe used fortrouble-freeand reliable operation.
It is power tested and approved according to IEC 62368-1.
Environment conditions
Allowed range
Temperature (flow channel / enclosure)
-10 –60 °C (14 –140 °F)
Air humidity (flow channel / enclosure)
5 –95% RH*
Absolute pressure in flow channel
50 kPa –200 kPa
Atmospheric pressure
54 kPa –110 kPa
Please refer to - (11 Measurement parameters and units). Here, you will also find
the conversion factors for the units of measurement.

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4.10 Battery operation
4.11 Directives and approvals
Operating time during battery operation: at least 4 hours.
Charging the battery
A complete charging process takes about 4 hours in normal conditions. The service life of the
battery is extended if the battery is not completely discharged. Do not store the device with a
discharged battery. Optimal state of charge for long term storage is 80 %.
• 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.
For the USB connection
V1.1 is used (12 Mbit)
For RJ-10 connection
If the device is to be actuated via the RS-232 interface, your dealer will be pleased to provide
you with a detailed protocol.
Simplified EU Declaration of Conformity
Hereby, IMT Analytics AG declares that the radio equipment type FloTest is compliant with
Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet
address: https://www.rigelmedical.com/gb/support/download/197/
The device is not intended for use outside a building.
The battery is not user replaceable and must not be replaced with a
different type. Doing so may lead to an explosion, burn or fire hazard.
The device indicates visually and audibly when the battery must be
charged. Please do not store the device if the battery is in a depleted state.
Caution: Complete depletion can damage the battery beyond repair!

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4.12 Device labels and symbols The following labels and symbols can be found on FloTest, packaging or accessories:
Symbol
Description
Warning notice
Power button
Alternating current
Class II equipment
For indoor use only
Direct current
Power input
USB Port to connect an USB flash drive
Serial interface
Conforms to CE Directives and Regulations
Safety Mark for North America for FloTest
Mark for proof of product compliance to North American safety stand- ards
Manufacturer
Date of Manufacture
The operating instructions should be considered when operating the
device
Serial Number
Waste Electrical and Electronic Equipment
Conformity with Low Voltage Directive 2014/35/EU
Mark for United Kingdom Conformity Assessment
This equipment contains specified radio equipment that has been certified
to the Technical Regulation Conformity Certification under the Radio Law
UDI Data
Matrix Code
Unique Device Identification
(01) GTIN-No.
(11) Production Date
(21) Serial No.

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Symbol
Description
Catalogue number
Keep dry
Protect from sunlight
Temperature for transport and storage
Humidity range for transport and storage
Atmospheric pressure for transport and storage
4.13 Feature Set The FloTest available features.
FloTest
Top cover
Grey
Flow measurement
±300 L/min
±1.9 % or ±0.05 L/min
Volume measurement
available
Absolute pressure in flow channel
available
Differential pressure ports
not available
Temperature measurement
available
Humidity measurement
not available
Bluetooth
available
Statistic screen
not available

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5 Start-up
5.1 Individual parts in the
packaging

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5.2 Power supply The power supply socket is located at the rear of FloTest.
5.2.1 Supply voltage
The mains voltage of the power supply is 100 –240 VAC at 50 –60 Hz.
5.3 Mechanical
connectors
5.3.1 Protection Filter RT019
To protect the device against contaminants and particles in the flow channel, the Protection
Filter RT019, must be used for flow measurements. Connect the Protection Filter RT019 to the
flow channel inlet port before connecting the device under test.
Particles of dirt in the air can clog the measuring system and thus lead to
incorrect measurements. The Protection Filter RT019 must be checked
regularly (8.3 Preventive cleaning and servicing routines).
The device can be disconnected from the mains by disconnecting the power
supply. The power supply should therefore be easily accessible.
Before switching on, make sure the operating voltage of the power supply
is compatible with the local mains voltage. You will find this information on
the rating plate on the back of the power supply.

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5.3.2 Flow channel
The flow channel can be used to perform gas flow measurements from -300 L/min to 300
L/min. The channel includes pressure and temperature sensors.
Measuring range & accuracy details: see chapter (4.1 Measurement parameters)
When working with relatively high humidity, ensure that condensation does
not form in the unit! Water can irreparably damage the sensors!
The device including the measurement channel shall not be exposed to high
level of volatile organic compounds (VOC). Doing so may lead to permanent
offset of the humidity sensor.

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5.4 Electrical
interfaces
5.4.1 USB connection for charging
The USB-C port is used to connect the power supply. The port is located at the rear of the device.
Rating: 5 V, 2.5 A
The device must only be connected to approved equipment with CE, CSA, UL or other equivalent
safety mark to ensure double insulation.
5.4.2 RS-232
The RS-232 interface is used for remote monitoring or control.
Actuation of the RS-232 port takes place via a special RS-232 cable. If the device shall be
actuated via the RS-232 interface, your dealer will be pleased to provide you with a detailed
protocol.
FloTest pin assignment (RJ-10 connector): Pin 1 NC
Pin 2 RxD (Input of FloTest)
Pin 3 TxD (Output of FloTest)
Pin 4 GND

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5.4.3 USB-A
The USB-A host connector can be used to connect a USB flash drive for data recording and
software update.
Rating: 5 V, 0.5 A
The USB flash drive must comply with the following requirements.
• File system: FAT32
• Volume size: 0.5 –32 GByte
USB hubs are not supported.

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6 Operation
6.1 Switching the FloTest The FloTest is switched on and off using the power button on the rear of the device
on and off
6.2 Acoustic feedback The FloTest provides a beep as acoustic feedback as follows:
Event
Duration of beep
Number of beeps
Power on/off
Short
1
Battery state of charge falls below 20 %
Short
1
Battery state of charge falls below 10 %
Short
2
Battery state of charge falls below 5 %
Short
3
Device shuts down due to empty battery
Long
1
Info message
Short
1
Warning message
Medium
1
Error message
Medium
3
6.3 User control gestures To operate the touch screen optimally and easily, use the gestures listed below
Gesture
Action
Function
Tap
Tap an element once
• Selection of menu
items
• Change between
Numerical view and
Chart view
Long press
(> 0.5 sec.)
Tap and hold for one
second
• Editing readings
and curves
Swipe
Drag your finger
across the screen
• Change views on the
measurement screen

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If the FloTest is switched on, the Measurement screen appears.