Rigel Medical FloTest User manual

rigelmedical.com
FloTest
USER MANUAL

RIGEL MEDICAL FloTest MANUAL
TESTED, TRUSTED…WORLDWIDE. 1
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.