Rigel Medical VenTest 800 User manual

rigelmedical.com
VenTest 800
USER MANUAL

RIGEL MEDICAL VenTest 800 Series USER MANUAL
TESTED, 2
INTRODUCTION 4
1. INTENDED USE 5
2. SAFETY INSTRUCTIONS 6
2.1.REPRESENTATION OF HAZARDS,CAUTIONS AND NOTES 6
2.2. PERSONNEL 6
2.3. RESPONSIBILITY AND GUARANTEE 6
2.4.SERVICE LIFE 6
3. SPECIFICATIONS 7
3.1.MEASUREMENT PARAMETERS 7
3.2.GAS STANDARDS FOR FLOW AND VOLUME MEASUREMENT 10
3.3. POWER SUPPLY 11
3.4.POWER SUPPLY 11
3.5.DIRECTIVES AND APPROVALS 12
3.6.DEVICE LABELS AND SYMBOLS 12
3.7.PCMINIMUM REQUIREMENTS 13
4. START UP 14
4.1.INDIVIDUAL PARTS IN THE PACKAGING 14
4.2.POWER SUPPLY 15
4.3.MECHANICAL CONNECTORS 15
4.4.ELECTRICAL INTERFACES 19
5. OPERATION 21
5.1.SWITCHINGTHE DEVICE ON AND OFF 21
5.2.THE START SCREEN 21
5.3.CHANGE CONTRAST 21
5.4.USER CONTROLS TERMINOLOGY 22
5.5.SPECIFICATIONOF USER CONTROLS 22
5.6.NUMERICAL DISPLAY 22
5.7.CONFIGURATION DISPLAY 24
5.8.STATISTICS DISPLAY 25
5.9.MENU DISPLAY 26
5.10.DATA STORAGE 27
5.11.RT200EMULATION MODE 29
5.12.CALIBRATIONS 30
5.13.GAS TYPE AND STANDARDS 31
5.14.SET TRIGGER 32
5.15.FILTER 35
5.16.SET LANGUAGE 35
5.17.HW ACTIVATION 36
5.18.CALL UP SYSTEM INFO 36
5.19.HIDDEN MENU OPTIONS 36
5.20.FACTORY DEFAULTS 37

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6. MULTIGASANALYSER OR-703 37
6.1.DESCRIPTION 37
6.2.USE 38
6.3.WARNING 38
6.4.PRINCIPLE 38
6.5.CONNECTION 39
6.6.LEDSIGNAL 40
6.7.ORSENSOR CALIBRATION 40
6.8.SERVICING AND CARE 41
6.9.TECHNICAL SPECIFICATIONS 42
7. MEASURING VENTILATION RATIOS 43
7.1.GENERAL 43
7.2.CONNECTING TO THE VENTILATOR 43
7.3.STANDARD TRIGGER VALUES 44
7.4.BASE FLOW 45
7.5.FINDING THE CORRECT TRIGGER VALUES 45
7.6.SPECIAL CASES 47
8. SERVICING AND CARE 48
8.1. GUIDELINES FOR SERVICING AND CARE 48
8.2. NOTES ABOUT CHANGING PARTS 48
8.3. PREVENTIVE CLEANING AND SERVICING ROUTINES 48
8.4.CONTACT 51
9. ACCESSORIES AND SPARE PARTS 52
9.1.ORDERING ADDRESS 52
9.2.DEVICE VARIANTS 52
9.3.OPTIONS 52
10. DISPOSAL 53
11. APPENDIX 54
11.1ABBREVIATIONS AND GLOSSARY 54
11.2. MEASUREMENT PARAMETERS AND UNITS 56
Revision 3.1

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Introduction
Validity
This documentation is valid for the product with the designation:
•VenTest 800, VenTest 810, VenTest 820
•MultiGasAnalyser OR-703
Youwill find the name VenTest on the rating plate on the back of your device. The
VenTest designation used in this manual applies to the models VenTest 800,
VenTest 810, VenTest 820.
Software and firmware version
This documentation applies to the following versions: VenTest firmware version 4.3.3
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 suchas Power and indicators on thedisplay such as Change Settings are
printed in boldface italics.
References to pages and sections
Forreferencestopagesandreferences,e.g.(→3.1.6Physicaldata), thesymbol
(→XY) is used.
Version information
Issue date of this User Manual: Release 06, 2022-02
Subject to technical modifications without notice.

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1. Intended use
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 touse
medical equipment andcan perform repairs,maintenance,andservicing on medical
devices.Thedevicecanbeusedinhospitals,inclinics,atdevicemanufacturersorat
independentservicecompaniesthatperformrepairsorservicingonmedicaldevices.
VenTest is intended for use in a 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 measuring instrument VenTest is intendedfor over-the-counter sale.
VenTest is the solution for measurements in the following areas:
•Flow Low (-20 20 L/min)
•Flow High (-300 300 L/min)
•Volume
•Differential pressure
•High pressure
•Ambient pressure
•Oxygen
•Temperature
•Air humidity
•Dew point temperature
In addition, various ventilation parameters can be measured:
•Inspiratory volume, expiratory volume
•Ventilation rate
•I:E
•Inspiratory time, expiratory time
•Ppeak
•Pmean
•Pplateau
•PEEP
•PF Insp (inspiratory peak flow)
•PF Exp (expiratory peak flow)
•Ti/TCycle
•Cstat
•Delta P
VenTest is a measuring instrument for checking and calibrating ventilators and
anaesthetic machines. It must not be used for patient monitoring. During patient
treatment by the ventilator it is not allowed to connect to FlowAnalyser.
This product is intended to be used at elevations of up to 2000 MASL in buildings.

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2. Safety instructions
2.1. Representation of hazards, cautions and notes
This User Manual uses the representation below to specifically draw attention to residual
risksduringintendeduseandemphasiseimportanttechnicalrequirements.
Information and/or instructions and prohibitions to prevent damage of any kind.
2.2. Personnel
Work on and with a VenTest may only be performed by persons who have
undergone appropriate technical training and have the necessary experience.
2.3. Responsibility and guarantee
Themanufactureracceptsnoresponsibilityorguaranteeandwillexemptitselffrom
liability claims accordingly if the operator or any thirdparties:
•fail to use the device in accordance with its intendeduse
•disregard the specifications
•tamper with the device in any way (conversions, modifications,etc.)
•operate the devicewith accessories thatare 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 serious
consequences if the device is used in non-compliance with the intended use
(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.
2.4. Service life
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.

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3. Specifications
3.1. Measurement parameters
3.1.1. Measuring instrument values1
Flow Low
Range Accuracy
-20 20 L/min
± 1.75% of reading or ± 0.04 L/min
Flow High
Range Accuracy
-300 300 L/min
± 1.75% of reading or ± 0.1 L/min
Volume
Range Accuracy
-100 100 L
± 2% of reading ± 0.02 L (Flow High)
or ± 0.01 L (Flow Low)
Pressure (at high flow)
Range Accuracy
0 150 mbar
± 0.75% of reading or ± 0.1 mbar
Differential pressure
Range Accuracy
-150 150 mbar
± 0.75% of reading or ± 0.1 mbar
High pressure
Range Accuracy
0 10 bar
± 1% of reading or ± 10 mbar
Ambient pressure
Range Accuracy
0 1150 mbar
± 1% of reading or ± 5 mbar
Oxygen
Range Accuracy
0 100 vol%
± 1 vol%
Humidity
Range Accuracy
0 100% RH (non-condensing)
± 3% RH
Temperature
Range Accuracy
0 50°C
± 1.75% of reading or ± 0.5°C
Dew point temperature
Range Accuracy
-10 50°C
± 2% of reading or ± 1°C
Additional pressure
sensors
For details please refer to the sections 4.3.6 Low pressure (PF-
302 LOW) and 4.3.7 Pressure sensor ±1bar (PF-301 VAC).
1 Standard litres per minute (converted to STP conditions of 21.1°C and 1013 mbar)

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3.1.2. Ventilation parameters
Vti, Vte
Tidal volume of
inspiration and
expiration
Range Accuracy
± 10 L
Flow High: ± 1.75% or
0.20mL (>6.0L/min) Flow Low: ±
1.75% or 0.10mL (>2.4 L/min)
Vi, Ve
Minute volume of
inspiration and
expiration
Range Accuracy
± 300 L/min.
± 2.5% or 0.02 L (Flow High)
0.01 L (Flow Low)
Ti, Te
Inspiratory and
expiratory time
Range Accuracy
0.05 60 s
± 0.02 s
Ti/Ttotal
Ratio of inspiratory
time to time of a
respiratory cycle
Range Accuracy
0 100 %
± 5 %
Ppeak
Maximum pressure
Range Accuracy
0 150 mbar
± 0.75% or ± 0.1 mbar
Pmean
Mean pressure
Range Accuracy
0 150 mbar
± 0.75% or ± 0.1 mbar
I:E
Inspiratory/expiratory
ratio
Range Accuracy
1:300 300:1
± 2.5 %
PEEP
Positive end-
expiratory pressure
Range Accuracy
0 150 mbar
± 0.75% or ± 0.1 mbar
Rate
Ventilation rate
Range Accuracy
1 1000 bpm
± 2.5% or ± 1 bpm
PF Insp.
Peak flow during
Inspiration
Range Accuracy
± 300 L/min
± 1.75% or ± 0.1 L/min
PF Exp.
Peak flow
during
Expiration
Range Accuracy
± 300 L/min
± 1.75% or ± 0.1 L/min
Cstat
Static compliance
Range Accuracy
0 1000 mL/mbar
± 3% or ± 1 mL/mbar
Pplateau
Plateau pressure
Range Accuracy
0 150 mbar
± 0.75% or ± 0.1 mbar
Delta P
Pressure
amplitude
(Ppeak PEEP)
Range Accuracy
0 150 mbar
± 0.75% or ± 0.1 mbar

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3.1.3. Principle of flow measurement
Flowintheflowchannelisdeterminedbydifferentialpressuremeasurement.Tobuild 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. 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 converted to
standard conditions. (3.2 Gas standards for flow and volume measurement)
3.1.4. Special functions
Automatic battery operation in theeventofa power failure.
3.1.5. 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
3.1.6. Physical data
Weight: 3.7 kg
Size (l × w × h): 22 × 25 × 12 cm
Gas types: Air, O2, N2O, He, N2, CO2 and mixtures: Air/O2, N2O/O2, He/O2
3.1.7. Calibration by user
Offset calibration of the pressure sensors, calibration of the oxygen sensor.
3.1.8. Operating data
Temperature: 15 40°C (59 104°F)
Air humidity: 10% 90% RH
Atmospheric pressure: 700 1060 mbar
Storage and transport conditions: -10 60°C (14 140°F) at 5 95% RH

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3.1.8. Extensions
•FlowLab software
•MultiGasAnalyser OR-703
3.2. Gas standards for flow and volume measurement
VenTest 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:
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 Conditions
USA
STP
21.1°C (70°F)
1013.25 mbar
(760 mmHg)
0 %
Standard Conditions
USA Humid
STPH
21.1°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 (HF)2
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 (HF)2
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 %

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Gas standard Temperature Pressure Relative humidity
Standard condition
according to ISO 1-
1975 (DIN 102)
20/981
20°C (68°F)
981 mbar
(736 mmHg)
0 %
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 %
2In order to measure BTPS / BTPD in the Flow Low channel, the rear end of the Flow Low channel has to be connected to
the Flow High channel in order to be able to include the temperature and humidity of the Flow High channel. See section
(4.3.3 Flow Low3)
Note: In this User manual the unit sL/min is based on ambient conditions of 0°C and 1013
mbar (DIN 1343).
Please refer to Appendix B: Measurement parameters and units. There you will also find
the conversion factors for the units of measurement
3.3. Power supply
Input voltage of the power supply unit: 100 240 VAC (± 10%), 50 60 Hz
Supply voltage: 15 VDC, 1.5 A
Power input: 25 V A
Only use the power supply unit and cable provided!
3.4. Power supply
Operating time in battery operation: 3 hours
Operating time in battery operation
with MultiGasAnalyser: 2 hours
Charging the battery
A complete charging process takes 8 h. The service life of the battery is extended if the
battery is charged completely only after a prompt by the device.
Note: The device indicates visually and audibly when the battery has to be charged.
Please do not store the battery in the depleted state.

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Caution: depletion can damage the battery beyond repair!
3.5. Directives and approvals
•IEC61010-1
•IEC61326-1
•CAN/CSA-C22.2 No. 61010-1-12
•UL 61010-1 3rd Edition
The device falls under Installation Category II.
The device is classified as Pollution Degree 2.
The device is not intended for use outside a building.
3.6. Device labels and symbols
The following labels and symbols can be found on FlowAnalyser:
Consult User Manual
Caution: observe the safety instructions in
the User Manual
Serial Number
Unique Device Identifier
IMT Analytics Reference Number
Direct Current
Legal Manufacturer Address
Do not dispose with household waste
Conforms with applicable CE directives
CSA mark for North America

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3.7. PC minimum requirements
•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)

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4. Start up
4.1. Individual parts in the packaging
FlowAnalyser
Power supply (Order no.
300.095.000)
USB cable
Calibration certificate
Filter
Adapter set

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4.2. Power supply
The power supply socket is located at the back of FlowAnalyser. The master switch is used
to switch the device on and off. The LED, labelled Charging, is lit when the battery is being
charged. This also takes place if the device is switched off.
Note: The device can be disconnected from the mains
using the power cord. The cord should therefore be
easily accessible.
4.2.1. 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
agrees with the local mains voltage. You will find this information on the rating
plate on the back of the power supply unit
Only operate a VenTest with the original power supply unit included!
4.3. Mechanical connectors
4.3.1. Filter
To protect the device against soiling due to contaminants and particles in the air the filter
included must be used for every measurement of flow (Flow High and Flow Low).
Particles of dirt in the air can clog the measuring system and thus lead to
incorrect measurements. The filter must be checked regularly (→8.3 Preventive
cleaning and servicing routines).
4.3.2. Adapter set
The adapters enclosed help to connect the test specimen to FlowAnalyser. Minimising
dead volume and differences in the diameter of the flow stream helps to increase the
accuracy of measurement. When using the LowFlow channel, the positive connector of
the differential pressure sensor is used for pressure measurements. With the tee enclosed
and the connecting tube the relevant ports can be connected to one another.

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4.3.3. FlowLow3
The Flow Low connector is used for measuring small flows. For calculating the venti- lation
7.3
Standard trigger values). The positive connector of the differential pressure sensor will
then be automatically used for pressure measurements. To connect the two ports the tee
can be used with the connecting tube from the adapter set.
Measuring range: -20 20 L/min
Accuracy: ± 1.75% of reading or ± 0.05 L/min
Note: The measurement channel of Flow Low does not have any additional sensors
for temperature, air humidity or oxygen concentration. For flow calculation the
current readings are transferred from the Flow High channel. For accurate
measurements it therefore makes sense to connect the Flow Low channel to the
Flow High channel using a tube. As a result the missing values can be measured.
For flows above 20 L/min measurement in the low flow channel is not accurate
enough.
3 Standard litresper minute (converted to STP conditions of 21.1°C and 1013 mbar)
4.3.4. Flow High4
The Flow High connector can be used for the following measurements:
•Large flows (-300 300 L/min)
•Volume
•Temperature
•Humidity
•Oxygen
•Pressure in the channel
Measurements can be conducted bidirectionally.
Flow Low
Flow High

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Flow High
Measuring range Accuracy
-300 300 L/min
± 1.75% of reading or ± 0.1 L/min
Volume
Measuring range Accuracy
0 10 L
± 2% of reading or ± 0.02 L
Temperature
Measuring range Accuracy
0 50°C
± 1.75% of reading or ± 0.5°C
Humidity
Measuring range Accuracy
0 100% (non-condensing)
± 3% RH
Oxygen
Measuring range Accuracy
0 100%
± 1% O2
Pressure in the channel
Measuring range Accuracy
0 150 mbar
± 0.75% of reading or ± 0.1 mbar
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!
4 Standard litres per minute (converted to STP conditions of 21.1°C and 1013 mbar)
4.3.5. Differential pressure
The differential pressure connectors can be used for differential pressure measurements.
Measuring range: -150 150 mbar
Accuracy: ± 0.75% of reading or ± 0.1 mbar
4.3.6. Low pressure (VenTest 820)
For VenTest 820 there is an additional sensor that is connected to the designated port.
The connecting nipple is marked with a blue ring.

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Measuring range: 0 5 mbar
Accuracy: ± 1% of reading or ± 0.01 mbar
Note: With the low-pressure variant a port of the differential pressure sensor (± 150
mbar) is connected to the remaining connector and the second one is connected
to the environment. The measuring range remains the same.
4.3.7. ± 1 bar pressure sensor (VenTest 810)
With VenTest 810 there is an additional ± 1 bar sensor that is connected to the designated
port. The connecting nipple is marked with a yellow ring.
Measuring range: -1000 1000 mbar
Accuracy: ± 0.5% of reading or 2 mbar
Note: With the ± 1 bar pressure sensor variant a port of the differential pressure sensor (±
150 mbar) is connected to the remaining connector and the second one is connected to
the environment. The measuring range remains the same.
4.3.8. High pressure
The high-pressure port can be used for measuring pressures above 150 mbar. If a
DISS-O2 connector is required for the port, an appropriate adapter can be ordered.
Measuring range: 0 10 bar
Lowpressure
± 1 bar pressure
sensor
High pressure

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Accuracy: ± 1% of reading or 10 mbar
With measurements up to 150 mbar it is recommended that the differential
pressure connector be used because there the accuracy is up to 100 times higher.
Pressures above 15 bar damage the sensor beyond repair!
4.4. Electrical interfaces
4.4.1. USB
The USB port is used for connecting VenTest to the PC. The port is located at the
back of the device.
If the device was ordered together with the FlowLab software, the measured values
can be displayed graphically on the computer. On devices without software the
USB port is disabled. It can be enabled with an activation code at any time.
Rating: 5V (+/- 0.25V), max 0.5 A
Use only a certified power supply for the computer / notebook which bears a CE,
CSA, UL or other equivalent safety mark to ensure double insulation
4.4.2. RS-232
The RS-232 interface is used for service purposes (firmware download), for
connecting to MultiGasAnalyser OR-703 and for external actuation of the device
and it is located at the back of FlowAnalyser.
Actuation of the RS-232 port takes place via a special RS-232 cable.
USB
RS-232

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If the device is to be actuated via the RS-232 interface, your dealer will be pleased
to provide you with a detailed protocol.
VenTest pin assignment (RJ-45 connector):
Pin 1 +5V (+/- 0.2V), max 0.5A
Pins 4, 5 GND
Pin 7 TxD
Pin 8 RxD
Pins 2, 3, 6 No connection
4.4.3. External trigger
The external trigger interface is used to start and stop volume measurement and to
determine ventilation parameters using an external signal. The input is electrically
isolated. A 4-pin cable with an FCC type RJ-10 connector must be used for input.
Pin assignment 1, 2 524VDC, max 50 mA
3, 4 GND
External trigger