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: +41 81 300 65 80 Email:
TestChest®@organis-gmbh.ch
Page 1: ...GmbH Version 3 01 2018 Page 1 of 36 Operator s Manual Originalbetriebsanleitung TestChest V3 Manufacturer Organis GmbH Schulstrasse 76 CH 7302 Landquart Telephone 41 81 300 65 80 Email TestChest organis gmbh ch ...
Page 2: ... 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 m...
Page 3: ...n 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...
Page 4: ...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 ...
Page 5: ...e 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 alt...
Page 6: ...est 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...
Page 7: ...nd 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 T...
Page 8: ...ger from electric shock or moving parts WARNING Warning If CO2 is used with TestChest make sure a proper exhaust is guaranteed Never use CO2 as 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 sta...
Page 9: ... 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 CO2 productio...
Page 10: ...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 ...
Page 11: ...he 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 S...
Page 12: ...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 CO2 connector tube Ø 4 mm 4 Leakage outlet 5 DB9 connector for analog output 6 J45 connector for Et...
Page 13: ...alog 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 ...
Page 14: ...s 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 ...
Page 15: ...ement 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 ...
Page 16: ...ixed 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 ...
Page 17: ... 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 ...
Page 18: ... 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 neces...
Page 19: ...heTestChest 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 ...
Page 20: ...le 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 ...
Page 21: ...es are disconnected from TestChest and that nothing is connected to the airway connector Step 6 Turn on TestChest by pressing the power switch After a short initialization phase TestChest is ready for operation The first time you use the ChestTest a calibration of the TestChest is absolutely necessary to achieve the desired operation accuracy The calibration process is described in Chapter 6 6 Cal...
Page 22: ...TestChest Operator Manual Organis GmbH Version 3 01 2018 Page 22 of 36 Step 7 Connect TestChest with the respirator The simulation can be started ...
Page 23: ...rameters The communication status is indicated by two LED indicators The left hand LED has three states green indicates normal communication with TestChest During calibration this LED is purple If communication errors occur the display turns red Then follow the instructions in the message field When the right hand LED remains green it indicates that TestChest has loaded all current parameters If s...
Page 24: ...itle bar of the window If required advanced users can create their own sets of parameters described in Chapter 6 2 3 which are then also available for selection from the main menu Additionally a selection of predefined spontaneous breaths is available which vary in strength of patient effort and duration The user can select one by simply clicking on the desired selection Via the Button Spontaneous...
Page 25: ... In addition to the compliance of the chest the elasticity of the lung is also taken into account Airway Resistance The physiological state of the respiratory tract particularly the respiratory muscles of the airways is modified by varying airway diameters which correspond to different airway resistances FRC at ZEEP Functional residual capacity the volume of air remaining in the lungs after normal...
Page 26: ...sure alveoli collapse Lung recruitment time constant Reflects how long it takes for the alveoli to open with a change in pressure above the opening recruitment pressure Lung collapse time constant Reflects how long it takes the alveoli to collapse with a change in pressure below the lung collapse pressure Lung recruitment factor Compliance during recruiting FRC predicted According to the predicted...
Page 27: ...eous breathing CO2 Production Rate of production of CO2 by the metabolism of O2 in the human lung gas exchange Cardiac output Cardiac output is calculated as the product of heart rate and stroke volume Heart Rate Heart rate Dead Space Dead space volume that is volume that is not involved in gas exchange in the human lung O2 diffusion limit This value a quotient of alveolar oxygen partial pressure ...
Page 28: ...cic pressure which is in turn influenced by respiration Phase shift heart lung interaction The phase shift indicates the time delay of the interaction between cardiac and thoracic pressure relationships Plethysmogram Influence Influence of heart lung interaction in the plethysmogram pulse pressure variation POPv at various pressures of Pcardio Pcardio is derived from the pleural pressure and the t...
Page 29: ...ssure 6 Cardial pressure Cardiac pressure 7 Fraction of O2 inspir Fraction of inspired O2 8 Ambient pressure Atmospheric pressure ambient pressure 9 Temperature in C Temperature in C 10 FRC actual Current functional residual capacity 11 Shunt fraction Shunt fraction 12 Partial pressure O2 chamber Partial pressure of O2 in the chamber 13 Partial pressure O2 effective Effective O2 partial pressure 1...
Page 30: ...nter the password directly at the highest security level All related tabs are then released When saving the data in each case the total configuration that is the states of all individual pulmonary parameters is stored This requires that all lung parameters be set to the desired state Then the name of the desired configuration can be entered through Choose Name at New Patient Name The button Go at ...
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Page 32: ...cing valve has to be mounted and set to max 4 bar Connect the CO2 supply and TestChest with a fixed tube nylon The connection to TestChest is suitable for a tube diameter of 4mm which can be connected simply by plugging in the hose To remove the hose simultaneously press on the connector ring and simultaneously pull the hose You adjust the amount of CO2 through the Basic Control software TestChest...
Page 33: ...sends the OxSim SpO2 simulator the current anticipated values heart rate oxygen saturation and perfusion through the data cable This generates the signals for the artificial finger The ventilator s pulse oximetry finger clip is clipped on this artificial finger and the generated values are transmitted to the ventilator ...
Page 34: ...ration Calboard Calibrate TestChest as follows 1 Disconnect all hoses from TestChest including the CO2 supply hose and the airway tube 2 From the Basic Control software tab Settings press the Start Calibration button 3 Calibration starts It takes about 3 minutes 4 TestChest is now ready for use CAUTION NOTE Calibration starts and takes about 3 minutes Touching and moving TestChest during this time...
Page 35: ...ervice AQAI Simulationszentrum Mainz Wernher von Braun Strasse 9 D 55129 Mainz Tel 49 6131 380 75 40 Fax 49 6131 380 75 49 wh aqai de www aqai de Trinity Trading Co Ltd Unit A 13 F Goodwill Industrial Building No 36 44 Pak Tin Par Street Tsuen Wan N T Hong Kong Tel 852 2385 6044 Fax 852 2770 1508 info trinity medical com www trinity medical com neosim AG Susenbühlstrasse 12 CH 7000 Chur Tel 41 0 8...
Page 36: ...TestChest Operator Manual Organis GmbH Version 3 01 2018 Page 36 of 36 8 Declaration of conformity ...
