Organis TestChest V3 User manual

Organis GmbH Version 3 01/2018 Page 1 of 36
Operator's Manual
Originalbetriebsanleitung
TestChest®V3
Manufacturer:
Organis GmbH
Schulstrasse 76
CH-7302 Landquart
Telephone: [phone]
Email: TestChest®@organis-gmbh.ch

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Table of contents
1. User information 3
1.1. Purpose of document and applicability 3
1.2. Safety information 5
2. General safety instructions 6
2.1. Introduction and intended use 6
2.1.1. Important information/restrictions 7
2.1.2. Technical specifications 9
2.2. Reasonably foreseeable misuse 10
2.3. Responsibility of the operator 11
2.4. Staff responsibilities 11
2.5. Staff qualifications 11
2.6. Safety and protective devices 11
3. Description of TestChest® 12
3.1. Structure of TestChest® 14
3.2. Assemblies and components 15
3.2.1. Active element 15
3.2.2. Calboard 16
3.3. Accessories 17
4. Transport / Storage 18
5. Installation and startup of theTestChest® 19
6. Operation (normal operation) 23
6.1 Device power-on and power-off 23
6.2. Basic Control software 23
6.2.1. Main menu 23
6.2.2 Changing lung parameters 25
6.2.3 Configure the Patient and Breath Library 30
6.3. Operation with CO2 32
6.4. Operation with oxygen 32
6.5. Operation with oximeter simulator 33
6.6 Calibration 34
7. Contact addresses 35

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1. User information
1.1. Purpose of document and applicability
These operating instructions describe the functioning, proper installation, operation,
maintenance, and repair of TestChest®. They contain important information for the safe
and efficient use of TestChest®.
The appendices to these operating instructions are part of this document.
1.2. Difference to earlier versions
TestChest V3 features the same functionality as earlier versions. There are no new risks or safety
concerns and the same maintenance and repair procedures apply.
However, the following features were added:
Feature
V2
V3
Measurement Stream
50 per second
100 per second
Lung collapse time constant
same as Lung recruitment time
constant
can be adjusted independent off
Lung recruitment time constant
SpO2 in apnea
SpO2 remains unchanged
SpO2 is reduced by 0.1 precent
points per second down to 70%
saturation, and increased at the
same rate if apnea is resolved.
Apnea is defined as volume
change smaller than 50ml per
30 seconds.
Total compliance when lung is
recruited
constant, always corresponds
to entered value
is increased when lungs are
recruited and decreased when
lungs are collapsing (see
formulas below)
Service diagnostics
accessible via USB port
accessible via USB port,
enhanded according to
description given in the Service
Manual
Pressure sensors
Ranges: -30..75mbar (Palv); +/-
250mbar (Paw)
Ranges: +/- 160mbar
You enter the following parameters via the user software (Parameter definitions see
Chapter 6.2):
Total Compliance, Crs(entered)
FRC at ZEEP , FRCmin
FRC predicted (FRpred), (depends on size of simulatetd patient)
The above parameters are used to calculate the expected compliance at fully recruited
lungs Crs(expected):

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Crs(expected) = Crs(entered)/FRCmin*FRCpred
Finally, the actual total compliance is calculated as follows:
Crs(actual)= Crs(expected)/FRCpred*(FRCmin+RecruitedVolume)
where RecruitedVolume is the actually recruited lung volume, gained by increasing the
inspiratory pressure above the entered threshold (Minimal recruitment pressure) for a
sufficient amount of time. «Sufficient amount of time» is defined by the «Time constant
recruitment» . The maximal value of Crs(actual) is Crs(expected).
IMPORTANT: Crs remains unchanged if the «Minimal recruitment pressure» is set high
enough so that it is never reached.

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1.2. Safety information
DANGER
Indicates an imminent danger.
If the information is not followed, death or serious bodily injury (disability)
will result.
WARNING
Indicates a potentially dangerous situation.
If the information is not followed, death or serious bodily injury (disability)
may result.
CAUTION
Indicates a potentially dangerous situation.
If the information is not followed, property damage or minor to moderate
bodily injury may result.
Note useful tips or tips to prevent possible property damage:
NOTE
Indicates general notes, helpful user tips, and work recommendations, but
which have no effect on personnel safety and health.
Emphasizes tips, recommendations, and information for efficient and
trouble-free operation.
Note major property damage (alternative):
CAUTION
Indicates a potential dangerous situation.
If the information is not followed, property damage will result.
Points out a potentially dangerous situation that can lead to property
damage when not avoided.

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2. General safety instructions
2.1. Introduction and intended use
TestChest® was developed to simulate the human heart and respiratory system for
teaching and training purposes. It can be used either as a stand-alone skill training
station or integrated into a full-scale patient simulator.
TestChest®® is further intended to check the functions of ventilators, CPAP devices, and
other respiratory support devices in laboratory facilities. In particular, TestChest®
permits the testing of closed-loop controlled ventilators for exhaled CO2and SpO2. Tests
described in ASTM 1100, EN 794-1, and IEC/ISO 60601-1-10 can also be performed with
TestChest®.
This new lung model supports the agile development process, the relevant regulatory
design and manufacturing testing; functional testing for hospitals and bioengineering,
and functional testing of respiratory support devices. In addition, TestChest® can be
used to verify specifications of lung function equipment, including measurements of tidal
volume, lung elasticity, V'CO2, and P0.1.
Unlike existing devices, TestChest® can test not only respiratory mechanics and
spontaneous breathing functions, but it also features the following:
1. Remote-controlled respiratory mechanics (resistance, elasticity, spontaneous
breathing activity, leakage)
2. Programmable FRC and non-linear (sigmoidal) elasticity curves.
3. Different types of spontaneous breath with operator-adjustable respiratory rate and
ventilation performance.
4. Hemodynamic interaction models allow the testing of closed-loop controlled
ventilators with the provision of SpO2and pulse pressure variation (POPv) as
appropriate in response to the ventilator setting.
5. Compatibility with wet gases.
6. Calibration based on national standards, due to the detachable Calboard module,
which includes all the sensor components.
TestChest®® is designed for the following uses:
7. Interaction with commercially available ventilators.
8. TestChest®® is a table model and must be operated in a horizontal position. e.g., on
a table, operating table, examination table, or the like.

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The front board corresponds to the end of the upper respiratory tract, with a connection
to the airway, a manually adjustable leakage valve, a CO2 connection, an Ethernet jack
for connection to a PC, a USB port for service purposes, and a jack for connection of the
artificial finger, that is, the pulse oximeter simulator.
The power cord connector and main switch are mounted on the rear panel.
WARNING
Warning, TestChest® may not be used:
- In humid and wet areas.
- At temperatures below 5°C or above 50°C
- In the vicinity of flammable materials
- In the vicinity of explosive materials
- In heavily polluted or dusty environements
- In harsh environments (for example, salty environments)
- With humidification
2.1.1. Important information/restrictions
The design of TestChest® is state of the art, and it is based on recognized safety rules.
The following general residual risks should be considered when using the device. Other
residual risks are described in the following chapters.

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WARNING
Make sure that the fan opening is not covered.
Make sure that the fan can not be blocked.
Blocking or covering the fan may result in a dangerous concentration of
oxygen within TestChest®, which can result in a fire hazard.
WARNING
Warning: TestChest® can be contaminated by previously connected fans.
WARNING
Warning: Never operate TestChest® without the housing completely closed
and secured.
Danger from electric shock or moving parts.
WARNING
Warning: If CO2is used with TestChest®, make sure a proper exhaust is
guaranteed. Never use CO2as a drive gas.
CAUTION
Caution: At startup, TestChest® performs an initialization maneuver before
it is ready for operation, resulting in a strong movement of the bellows.
High pressures during this maneuver may damage any devices connected
to TestChest®. Before starting up TestChest®, check that all devices are
disconnected from TestChest® and that nothing is connected to the airway
connector.
NOTE
Perform regular leak and functional tests on TestChest®. The test intervals
are specified in the Service and Maintenace Manual, Chapter

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2.1.2. Technical specifications
Dimension
Unit
Length
685
mm
Width
292
mm
Height
202
mm
Weight
16
kg
Electrical and pneumatic supplies
Unit
Voltage
110/230
VAC
Frequency
50/60
Hz
Wattage
520
W
CO2 supply
Max. 4
bar
Parameter
Range
Unit
Total compliance
8 to 60
ml/mbar BTPS
Measured FRC
300 to 4000
ml
Spontaneous breathing activity (P0.1)
0 (passive patient) to 15
mbar/100 ms
Spontaneous breathing frequency
0 (apnea) to 100
/min
Upper and lower inflection points
0 (no inflection point) to 100
mbar
Chest wall compliance
3 to 200
ml/mbar
Predicted FRC (according to physiological
model)
100 to 4000
ml
Alveolar pressure
+/- 160
mbar
Airway pressure
+/- 160
mbar
Bellows, measured temperature
0 to 50
°C
Measured barometric pressure
800 to 1100
mbar
End-expiratory lung volume
Approximately 500 to 4000
ml
Breath volume
1 to 2500
ml BTPS
Options
Range
Unit
CO2production
0 (no CO2production) to 500
ml/min STPD
SpO2 simulation
80 to 100
%
Pulse rate
20 to 300
bpm
Plethysmograph. variation of the SpO2
signal
-30 to 100
%
Leakage
3 leak sizes, manually
adjustable
Arbitrary
Cardiac output
500 to10000
ml/min
Dead space
approximately 175, 190, 205
ml
FAO2
0 to 100
vol %
Raw
Rp5, Rp20, Rp50, Rp200
hPa/ (L/s)

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Interfaces
Airway connector: 22M-15F, compliant with EN/ISO 5356-1
Ethernet connection: J45 jack
Pulse oximeter simulator (artificial finger): DB9 receptacle
Service connection: USB connector
Analog output: DB9 header
The Declaration of Conformity is located in the appendix to these instructions.
2.2. Reasonably foreseeable misuse
Use of the device other than that specified under "intended use" constitutes improper use
and is prohibited. Any other use requires consultation with the manufacturer.
Modifications/changes:
Unauthorized modifications and changes to TestChest® void any warranty by the
manufacturer.
Spare and consumable parts and supplies:
The use of spare and consumable parts from third parties can be hazardous. Use parts
from the original manufacturer-only.

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2.3. Responsibility of the operator
The operator shall permit the use of the device only by people who:
1. Are familiar with basic rules of workplace safety and accident prevention
2. Are trained to work on the device
3. Have read and understood these operating instructions.
2.4. Staff responsibilities
All persons who work on the device must:
1. Observe the basic rules of workplace safety and accident prevention,
2. Have read, understood, and observe the safety notices in the safety chapter of this
manual.
2.5. Staff qualifications
Persons
Activity
Specially trained
operators
Persons with specialized training
(mechanical /electrical engineering)
Transport
X
X
Installation
X
X
Troubleshooting and
fault elimination
--
X
Operation
X
X
Service
--
X
Legend: X Permitted -- Not permitted
2.6. Safety and protective devices
TestChest® may be operated only with an appropriate, completely closed housing.
Otherwise, further operation is prohibited.

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3. Description of TestChest®
The Test Chest includes two bellows (which are driven by a linear motor); sensors for
alveolar pressure, airway pressure, and environmental pressure; a temperature sensor;
and a real-time clock.
Optionally available are:
Intrapulmonary oxygen sensor, mass flow controllers for proportioning CO2, an "artificial
finger" for simulation of the pulse oximetry signal; and programmable dead space
volume, leakage, and variable airway resistance (during operation).
Front view: Rear view:
1
Airway connector, connection to the ventilator
2
Manually adjustable valve for leakage
3
CO2connector, tube Ø 4 mm
4
Leakage outlet
5
DB9 connector for analog output
6
J45 connector for Ethernet
7
USB-B connector for service
8
DB9 connector for pulse oximeter simulator
9
ON/OFF switch
10
Fuse (10 A)
11
Low power device panel connector C14

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DB9 connector for analog output
Ppl pPleural Druck -50 - 100 mbar
Palv alveolar pressure -20 - 100 mbar
Pmusc muscular activity -50 - 50 mbar
VL tidal volume 0 - 5 Liter
Pin configuration for analouges output DSUB9/m is as follwing:
- Pin 4: Ppl
- Pin 7: Palv
- Pin 8: Pmusc
- Pin 9: VL
The residual pins are GND
Voltage range DAC: 0 - 3.3V

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3.1. Structure of TestChest®
TestChest® consists of three modules:
1
Active element
This includes the base frame with the structural elements for the drive: the
drive for the horizontal movement of the bellows as well as the entire electrical
supply.
2
Calboard
The Calboard includes connector sockets, actuators, sensors, and electronics
3
Housing
The housing consists of four parts and protects the operator from electrical and
mechanical hazards

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3.2. Assemblies and components
3.2.1. Active element
The active element consists of the following components
1
Base frame
The base frame provides the structural basis for the mechanism and the
housing.
2
Drive
The drive is carried out by a linear motor, which is guided by two parallel rods.
3
Bellows
The two bellows hold up to 4.5 l volume, mirroring the lung volume.

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3.2.2. Calboard
The Calboard consists of the following components:
1
Flow restrictor
The flow restrictor or airway resistance may be adjusted during operation to
these fixed sizes: Rp5, RP20, RP50, and RP200.
2
Dead space
Dead space can be adjusted via control valves to three levels.
3
Oxygen sensor
The oxygen sensor measures the oxygen content of the respiratory gas that is
reduced by the insufflated CO2. (This is how oxygen consumption is simulated.)
4
Mass flow Controller
The mass flow controller controls the intake of CO2.
5
Leakage
Leakage is controlled through valves, and the level is also manually settable.

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3.3. Accessories
OxSim
OxSim is a pulse oximeter simulator. This
processes the parameters set on the PC for
heart rate, oxygen saturation, and perfusion
index, and it and generates the applicable
signals.
OxSim cable
The data cable between TestChest® und
OxSim, including the electrical supply for
the OxSim
Basic Control operating software
Communication software, to control
TestChest® based on the operator-
adjustable parameters and to display
parameters measured by TestChest®.

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4. Transport / Storage
For transport purposes, it is essential that TestChest® flow restrictor be set to RP200. In
addition, the Basic Control software must be shut down/terminated and then TestChest®
powered off. This prevents the linear motor from becoming misaligned.
As an additional security measure during transport, a transport lock can be installed in
the airway opening to prevent undesired movement of the linear motor.
Install transport lock
Transport lock
CAUTION
Caution: If TestChest® is not turned off in the correct order (that is, first
turn off the Basic Control program, then power down TestChest®) and/or
no transport lock is fitted to TestChest®, damage to TestChest® may
result.
Adequate stable and padded packaging is necessary to protect TestChest® from damage
during transport. Organisms GmbH offers an optional carrying case for TestChest®.
Storage:
Keep TestChest® in a dry place at room temperature between 5°C and 40°C.

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5. Installation and startup of theTestChest®
Step 1
Place TestChest® in a horizontal position, e.g., on a table, operating table,
patient examination table, or the like.
NOTE
TestChest® is a table model and must be operated in a horizontal position.
Otherwise, measurement or simulation errors may result.
Step 2
Connect the power cord to TestChest®.

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Step 3
Connect the OxSim to TestChest® with the supplied cable, as shown.
NOTE
TestChest® supplies electrical power to the OxSim. The OxSim is not
required to run on batteries while connected to TestChest®. Turn the
OxSim ON/OFF switch to the OFF position.
Step 4
Connect the laptop to TestChest® with a RJ45 patch cable (Ethernet).
NOTE
Requirements for the laptop:
Microsoft Windows 7 operating system