Summary of Contents for Thornhill Medical RESPIRACT RA-MR
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Operator’s Manual CAUTION: • Investigational Device: Limited by Federal Law to Investigational Use Only • Investigational Device: To Be Used by Qualified Investigators Only • Instrument de Recherche : Réservé uniquement à l'usage de chercheurs compétents...
RA-MR™ Operator’s Manual Thornhill Research Inc. Table of Contents DEVICE INFORMATION ............................... 2 MANUFACTURER INFORMATION ........................... 2 SYSTEM INFORMATION ............................. 2 ’ 2.1............................2 YSTEM NTENDED ’ 2.2..........................2 YSTEM NTENDED PERATOR ’ 2.3...................... 2 YSTEM NTENDED PERATING NVIRONMENT ’...
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RA-MR™ Operator’s Manual Thornhill Research Inc. STAND AND OXYGEN RESERVOIR ASSEMBLY INSTRUCTIONS..............69 10.1 ..............................69 TAND SSEMBLY 10.2 ..............74 OUNTING UNIT ON STAND AND INSTALLING OXYGEN RESERVOIR 10.3 ........78 EMOVING UNIT FROM STAND FOR SHIPPING FOR CALIBRATION AND MAINTENANCE...
RA-MR™ Operator’s Manual Thornhill Research Inc. DEVICE INFORMATION Device Name: RA-MR™ Device Model: RA-MR 1. MANUFACTURER INFORMATION Thornhill Research Incorporated 60 Wingold Avenue Toronto, Ontario, Canada M6B 1P5 2. SYSTEM INFORMATION ’ 2.1. S YSTEM NTENDED The intended use of the RA-MR™ system is to control end-tidal partial pressures of CO &...
RA-MR™ Operator’s Manual Thornhill Research Inc. Relative contraindications: • Pregnancy • Obtundation • Coma • Confusion • Delirium • Dementia • Unable to understand or carry out commands regarding keeping still and breathing pattern • Increased intracranial pressure due to space occupying lesion of obstruction of outflow of CSF •...
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RA-MR™ Operator’s Manual Thornhill Research Inc. System Block Diagram...
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.1.1. RA-MR™ CONTROL ROOM UNIT The FRONT PANEL of the RA-MR™ CONTROL ROOM UNIT is pictured below. Windows A and B are shown in greater detail below.
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RA-MR™ Operator’s Manual Thornhill Research Inc. The function of each component is as follows: Emergency Stop – Pressing this will ensure that the system is in a safe state, where the subject breathes room air with no supply gases added. Once engaged, it must be reset manually by rotating the button clockwise.
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RA-MR™ Operator’s Manual Thornhill Research Inc. The BACK PANEL of the RA-MR™ CONTROL ROOM UNIT is pictured below.
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RA-MR™ Operator’s Manual Thornhill Research Inc. The functions of each component are as follows: Power switch – Turns control room unit power on or off. NOTE: RA-MR™ USER INTERFACE has separate power switch. Power cord adapter – Connect only the supplied medical grade power cord. User Interface –...
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.1.2. The RA-MR™ MRI UNIT The FRONT PANEL of the RA-MR™ MRI UNIT is pictured below. The function of each component is as follows: gas outlet – Connects the appropriate gas line (yellow) from the mask hosing. 1) CO 2) Breathing hose- Connects the appropriate line from the mask hosing.
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RA-MR™ Operator’s Manual Thornhill Research Inc. The BACK PANEL of the RA-MR™ MRI UNIT is pictured below. The functions of each component are as follows: ) – Connect the appropriate gas line (Green) in the RA-MR™ HOSE 6) Gas C inlet (100% O AND FIBER BUNDLE.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.1.3. THE RA-MR™ SUBJECT BREATHING CIRCUIT AND CONSUMABLE MASK AND CIRCUIT • Use the RA-MR™ System only with a disposable breathing mask manifold supplied by Thornhill Research Inc. • Connect the RA-MR™ SUBJECT BREATHING CIRCUIT to the RA-MR™ Control ROOM UNIT and to the RA-MR™...
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RA-MR™ Operator’s Manual Thornhill Research Inc. 5. Connect the RA-MR™ HOSE AND FIBER BUNDLE to the rear panel of the control room unit and to the rear of RA-MR™ MRI UNIT. The end of the RA-MR™ HOSE AND FIBER BUNDLE that attaches to the RA-MR™ CONTROL ROOM UNIT has a red band with the following label:...
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RA-MR™ Operator’s Manual Thornhill Research Inc. • When connecting the RA-MR™ HOSE AND FIBER BUNDLE to the RA- MR™ MRI UNIT, always start with the base gas line first (the center blue line). Continue with the yellow and green gas lines. •...
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RA-MR™ Operator’s Manual Thornhill Research Inc. • To connect the RA-MR™ HOSE AND FIBER BUNDLE gas lines to the rear panel of the RA-MR™ MRI UNIT, first depress the tab on the connector as shown in the following picture then insert the gas line into place (to remove the connection, depress the tab).
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RA-MR™ Operator’s Manual Thornhill Research Inc. Connect lines from the RA-MR™ SUBEJCT BREATHING CIRCUIT to front of RA-MR™ MRI UNIT and to RA-MR™ CONSUMABLE MASK AND CIRCUIT (see picture below): NOTE: THE MASK MUST NOT BE ON THE SUBJECT’S FACE AT THIS POINT. 9.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.2. S TARTING THE PROGRAM The RA-MR™ System program will automatically start once the RA-MR™ User Interface is turned on. However, if the program was previously exited (such as exiting to perform data and file management), the program may be re-accessed by double-click the ‘RA-MR™ System User Icon’...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Two high priority alarms in red will appear at the bottom of the screen indicating the RA-MR™ CONTROL ROOM UNIT and the RA-MR™ MRI UNIT are disconnected.
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RA-MR™ Operator’s Manual Thornhill Research Inc. The device status found in the bottom left corner will indicate a disconnection. If you wish to enter/save a study and build/save sequences, without preforming any actual subject testing, select ‘Build a study’. Otherwise quit the program, turn off RA-MR™ CONTROL ROOM UNIT, confirm connection between all units, wait for at least ten seconds, turn on RA-MR™...
RA-MR™ Operator’s Manual Thornhill Research Inc. The device state will indicate it is not calibrated: 3.3. B UILD A STUDY The ‘Build a Study’ option allows study population parameters to be designated and gas target sequences to be built and saved. This option is active regardless of whether communication between the units and RA-MR™...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Choosing the ‘New’ option brings the user to the following screen: The default name given is ‘New study’, however the user may change this to assign a new name to the study. The ‘Study Population’ panel is used to enter the study population demographics, such as the maximum and minimum height (ranging between 100-225cm), weight (ranging between 30 to 200kg), age range of the population (ranging between 8 to 100 years old), as well as sex and ventilated options.
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RA-MR™ Operator’s Manual Thornhill Research Inc. The ‘Study Location’ panel is used to enter the barometric pressure limits of the study environments between 485 mmHg – 760 mmHg. The ‘Source Gases’ panel is used to change the default source gas concentrations. For example, if O targeting or control is not a priority, you may select the ‘Use Room Air’...
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RA-MR™ Operator’s Manual Thornhill Research Inc. The ‘Sequence’ panel is used to build a study sequence. To build a sequence: • Enter default resting P (mmHg) and P (mmHg) (the automatic defaults are 40mmHg for resting P and 116mmHg for P and are only for the graph display purposes found on the bottom left of the sequence panel.
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RA-MR™ Operator’s Manual Thornhill Research Inc. • Enter a new stage by pressing the ‘Add Stage’ button. Note: stages run sequentially and seamlessly. • Enter the Type of pattern, Target P (mmHg), Target P (mmHg), Priority and Stage Duration (see definitions below). •...
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RA-MR™ Operator’s Manual Thornhill Research Inc. occurs during transitions from one set of targets to another. In this case, not the target value but the speed of attaining the target must be optimized. If no priority is set, the sequence generator will attempt to optimize both and P determines how to achieve the desired target in the fewest number of breaths.
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RA-MR™ Operator’s Manual Thornhill Research Inc. • To copy or delete a stage, select the desired stage line and the two options will appear. • To move a stage line up or down the order list, select the desired stage line and “drag and drop” it into the desired order.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.4. E ARTICIPANTS The ‘Edit Participants’ option is used to enter and save participant information. To enter a new participant, select the ‘New’ option at the bottom left of the screen to bring up a screen to enter a name, height, weight, date of birth, sex and whether the subject is ventilated or not.
RA-MR™ Operator’s Manual Thornhill Research Inc. Once all subject information is entered push ‘OK’. The main edit participants screen will appear with the saved subject information shown in the subject list on the left panel. Highlighting a subject of interest shows the participant’s information in the right panel. The copy option copies the highlighted participant’s information and that edit option edits the highlighted participant’s information.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Prior to calibrating the device ensure the foam plug insert is placed into the RA-MR™ CONSUMABLE MASK so that it covers the opening of the mask (pictured in figure 1). Ensure it stays in place during the entire calibration and verification process. Remove and dispose of the foam insert at the same time as RA-MR™...
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RA-MR™ Operator’s Manual Thornhill Research Inc. The CO and O percentages for gases B and C of 10%O , 90%CO and 100%O respectively, come from the last selected study. If different gas concentrations are required (e.g. for studies requiring hypoxia), then proceed to run a study where there is an option to enter the source gas concentrations. *The source gas concentrations used must be entered into the program correctly for a proper and successful calibration and verification*.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Next, the system will calibrate the CO and O sensor spans; first calibrating for low CO and high O and then vice versa. The following screens will appear: Next, the system will verify the Control Room (Only if Gas A is used instead of room air) and MR room valve.
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RA-MR™ Operator’s Manual Thornhill Research Inc.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Oxygen will then be flushed through the system to clear any CO Verification is then complete. If calibration and verification were successful, the following screen appears with the system state verified and indicating ready to proceed.
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RA-MR™ Operator’s Manual Thornhill Research Inc. If ‘OK’ is pressed the following screen will appear with two options: To proceed to the next step of Study Preparation—press ‘Back’. To exit the automatic calibration screen and return to the main menu, press ‘Back’ to return to the startup home screen.
RA-MR™ Operator’s Manual Thornhill Research Inc. Should calibration or verification fail, the screen will indicate which state failed. Ensure all gases are fully turned on, system is fully connected properly and retry calibration/verification 3.6. S YSTEM Displays version number of the RA-MR™ System program software, the RA-MR™ MRI UNIT version and the RA-MR™...
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RA-MR™ Operator’s Manual Thornhill Research Inc. After the expiry date has passed and 3 additional sessions have been used, the software will no longer be useable and will require a new license file to unlock the system. Please download the latest software/license file from the forum at www.respiract.com.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.7. D EPRESSURIZE Removes gases in the gas supply lines to make it easier to disconnect and connect the gas supply lines to the RA-MR™ CONTROL ROOM UNIT. Prior to depressurizing the system ensure all four gas sources are fully closed.
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RA-MR™ Operator’s Manual Thornhill Research Inc. NOTE: THE MASK MUST NOT BE ON THE SUBJECT’S FACE AT THIS POINT. To begin running a study, press the ‘Run Session’ option. The user will be prompted to choose a study from the studies listed in the panel on the left. Users have the ability to create, copy, edit and delete studies at this stage.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Once a study is selected, pressing ‘Next’ will bring up the following screen where modifications to the selected study can be made. For instructions on navigating this screen please refer to section 3.3 Build a study.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Choose ‘OK’ to move to the next step or cancel to return to the choose-a-study screen option. Next, choose a participant from the studies listed in the panel on the left. Participants can be created, copied, edited and deleted at this stage.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Choosing ‘Cancel’ exits to the subject selection screen. Choosing ‘OK’ exits to the calibration and verification stage. If calibration and verification has been done previously (‘Device state’ at bottom right of screen will indicate device calibrated), the next option is activated and the user should proceed to the next step.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.9. M AIN USER SCREEN The main screen, in brief, displays the subject’s respiratory parameters, gas flows and alarms. Basically, it is used to monitor the subject’s , and the progress of the sequence throughout the experiment.
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RA-MR™ Operator’s Manual Thornhill Research Inc. 2a. Preparation Test- Prior to running a sequence a preparation and virtual sequential gas delivery (VSGD) test is performed to determine initial mixed-venous concentration of CO 2b. Baseline PCO and PO - When enters into a regular, relaxed breathing pattern, the RA- consumption and baseline (‘resting’) PCO calculates baseline CO production, O...
RA-MR™ Operator’s Manual Thornhill Research Inc. a) G1, is used for targeting; participates in gas exchange. b) G2, is used for equalizing end-tidal to arterial; does not participate in gas exchange. Always make sure G2 does not fall below zero. If it is getting small, ask subject to take bigger breaths or breathe more frequently.
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RA-MR™ Operator’s Manual Thornhill Research Inc. 2. Cut the two pieces of Tegaderm in half horizontally 3. Remove the head straps on the RA-MR™ Subject Mask...
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RA-MR™ Operator’s Manual Thornhill Research Inc. 4. Cut the lip around the mask and place mask on subject 5. Beginning with the top of the mask, remove the protective backing from a piece of Tegaderm, and place the Tegaderm on the skin and mask (over the bridge of the nose, just under the eyes).
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RA-MR™ Operator’s Manual Thornhill Research Inc. 6. Continue by placing a piece of Tegaderm under the chin 7. Tape sides of mask, asking subject to keep their eyes closed. Overlap tape placed over nose and chin...
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RA-MR™ Operator’s Manual Thornhill Research Inc. 8. Make sure there are no leaks, ask the subject if they can feel any air coming out around the edges of the mask and tape (specifically around the nose/eye area) NOTE: It is very challenging to seal the mask on subjects with beards. In these instances, ask the subjects to shave prior to the procedure.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.10.2. Run Prep Once the subject is attached to the system via the facemask, allow the subject to breathe for a minute or more, and observe the subjects’ breathing has stabilized using the real time gas monitoring graphs on the Main User screen.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Inconsistent breathes End tidal peak values not aligned with peaks Example of a good prep Consistent breathes End tidal peak values aligned with peaks...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Note: Time in stabilization phase is dependent on subject. The system will not notify the user if the preparation test preformed was adequate. It is up to the user to determine if preparation test was successful.
RA-MR™ Operator’s Manual Thornhill Research Inc. 3.10.3. Run Sequence When the user and subject are ready, pressing the ‘Start Sequence’ option begins the desired targeted sequence run chosen previously. The built study sequence will appear on the end tidal history graph with a ‘Start Sequence’...
RA-MR™ Operator’s Manual Thornhill Research Inc. FIBER BUNDLE from the back of both the RA-MR™ CONTROL ROOM UNIT and the RA-MR™ MRI UNIT. 3.11. ILES There is no need to save anything at the end of a session. All data is saved automatically to the directory C:\Users\RA-user\My Documents\RA-MR (this can also be found by simply clicking on the “Documents”...
RA-MR™ Operator’s Manual Thornhill Research Inc. (mmHg) – The latest calculated resting end tidal CO Resting PCO valueh. PBaro (mmHg) – The measured barometric pressure. Inspire time (seconds) – The length of inspiration for the breath. Expire time (seconds) – The length of expiration for the breath. Breath idx –...
RA-MR™ Operator’s Manual Thornhill Research Inc. 4 Warnings and Precautions RA-MR™ has not been approved for use as a medical device. The system must only be used by qualified researchers in accordance with an Ethics Review Board and Health Canada/IDE approved protocol.
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RA-MR™ Operator’s Manual Thornhill Research Inc. LIGHT OR NO INDICATOR LIGHT INDICATES MR ROOM UNIT IS TOO CLOSE TO MAGNET. MASK, MANIFOLD AND FILTERS (BUT NOT THE NAFION TUBE) ARE DISPOSABLE AND SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL BIOHAZARD REGULATIONS.
RA-MR™ Operator’s Manual Thornhill Research Inc. 5 SOFTWARE ALARMS & ERRORS Alarm Alarm Alarm Text Alarm Cause Operator Option Source Priority Ensure that all source gasses are connected Calibrate without Calibration Failed properly, the source tanks are opened and gas on regulators are set to approximately 50psi.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Detected flow at Ensure that a subject is not connected to the unit the mouth while when calibrating or verifying. Detected flow at Medium waiting for Do not hold the circuit while calibrating or mask calibration/verific verifying and ensure circuit is away from strong...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Ensure that oxygen tank is fully open, regulator set to approximately 50psi and is connected to PO₂ measured at control room unit. subject < CTRL High Low PO₂ Ensure that green hose is connected on both ends 70mmHg for >= of umbilical cord.
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RA-MR™ Operator’s Manual Thornhill Research Inc. communicate all possible alarms MR room unit did Incomplete MR not communicate Disconnect then reconnect serial cable. Medium Alarm Descriptions all possible Power cycle subject unit. alarms Control room unit CtrlRoom Alarm did not Disconnect then reconnect serial cable.
RA-MR™ Operator’s Manual Thornhill Research Inc. 6 SPECIFICATIONS 6.1 O PERATING NVIRONMENT • Operating Temperature: 15C - 30C • Altitude: up to 10,000 ft (tested at sea level) • Humidity 10% to 90% RH (non-condensing) • Magnetic Field: < 50 Gauss •...
RA-MR™ Operator’s Manual Thornhill Research Inc. 7 SYSTEM SUPPLY LIST REQUIREMENTS The system requires the use of only medical grade gas. The following gases are needed to use the RA- MR™ System: • Gas A: 10% O , 90% N (Attached supply line with BLUE quick connect to this regulator) between 8.0-15.0% is acceptable) •...
RA-MR™ Operator’s Manual Thornhill Research Inc. 8 SERVICE AND MAINTENANACE SCHEDULE ◦ and the RA-MR™ MRI UNIT needs to be The RA-MR™ CONTROL ROOM UNIT calibrated annually by Thornhill Research Inc., according to the calibration stickers attached to the device. ◦...
RA-MR™ Operator’s Manual Thornhill Research Inc. 9 PACKING AND UNPACKING INSTRUCTIONS 9.1 U NPACKING NSTRUCTIONS *May not be exactly as shown, items may vary WARNING: THE RA-MR™ SYSTEM CASE MUST BE UNPACKED AND PACKED OUTSIDE THE MRI ROOM. Remove this manual from the case Remove the screen from the case, do not discard the foam, it will be needed to send the unit back for calibration/maintenance Remove the foam with cut-outs, do not discard the foam, it will be needed to send the unit back for...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Remove the white cardboard box and the control room unit from the case Remove the small piece of foam in the centre cavity, do not discard the foam, it will be needed to send the unit back for calibration/maintenance Remove the MRI Room Unit from the case You should now have the manual, screen, white cardboard box, Control Room Unit and MRI Room...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Remove the bags from the Screen, Control Room Unit and MRI Unit Open the white cardboard box and remove the components. They are: • • Screen Manufacturer Documentation Control Room Unit Power Cable • •...
RA-MR™ Operator’s Manual Thornhill Research Inc. 11 Place the large foam pieces back in the case, close and latch the case. Store the case until it is needed to ship RA-MR™ for it’s scheduled servicing and calibration 9.2 R EPACKING NSTRUCTIONS *May not be exactly as shown, items may vary Open Case and remove 3 pieces of foam, white cardboard box and 3 bags...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Place the Screen, Control Room Unit and MRI Room Unit in their respective bags Place the MRI Room Unit in the centre cavity of the case Place the small piece of foam on top of the MRI Room Unit in the case Place the Control Room Unit and white cardboard box in the case as shown...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Place the foam over the Control Room Unit and white cardboard box Place the remaining foam piece around the base of the screen and slide it into the case Ensure that the stand base does not overlap the edge of the case and that all items are fully into the case 10 Close case and close all 5 latches...
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RA-MR™ Operator’s Manual Thornhill Research Inc. 10 STAND AND OXYGEN RESERVOIR ASSEMBLY INSTRUCTIONS 10.1 TAND SSEMBLY NOTE: Assembly of the MRI Unit Stand and Attachment of the MRI Unit to the stand must be done OUTSIDE THE MRI ROOM. Hex keys are ferromagnetic. WARNING: ASSEMBLY OF THE MRI UNIT STAND MUST BE DONE OUTSIDE THE MRI ROOM.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Separate the base from the pole Locate the open side of the black plastic bushing, force it open and slide the bushing off the end of the Pole. Keep the bushing for later use Slide the Two aluminum plates over the Pole.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Note the larger diameter end of the Bushing. Install the Bushing over the Pole leading with this larger end There are five legs and one base to assemble in this step. Remember to keep the lock washer under the head of the all the screws Locate the two legs with BRAKES on the casters and attach both legs with one empty slot between them...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Flip the Base onto its casters and lower the pole into the base Paying special attention to the position of the two Casters with BRAKES, align the Plate atop the Pole to be centered between the BRAKES as shown and firmly push down on the top plate Lay the Stand on the floor with care not to twist the pole with relation to the Base.
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RA-MR™ Operator’s Manual Thornhill Research Inc. Place the Stand upright on its casters. Align both Plates as shown Tighten all FOUR Set Screws applying high torque. This secures the two plates in their correct orientation...
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RA-MR™ Operator’s Manual Thornhill Research Inc. 10.2 OUNTING UNIT ON STAND AND INSTALLING OXYGEN RESERVOIR WARNING: ATTACHMENT OF THE MRI UNIT TO THE STAND MUST BE DONE OUTSIDE THE MRI ROOM. HEX KEYS ARE FERROMAGNETIC. Obtain the RA-MR™ MRI Unit, two holding Screws, Lock Washers and Hex Key Place the MRI Unit on the Stand Install one Screw and Lock Washer leaving it slightly loose...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Install and TORQUE the second Screw and Lock Washer TORQUE the first Screw Remove the Oxygen Reservoir from the Box and Plastic Bag...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Remove the Orange Cap on at the bottom of the MRI Unit Place the Cream Color Flange at the bottom of the MRI Unit. Mind the Offset orientation Place the Filter on top of the Bushing of the Top Plate Feed the Oxygen Reservoir Hose through the holes in the Bottom Plate...
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RA-MR™ Operator’s Manual Thornhill Research Inc. Pull both end of the Hose up to connect to the Cream Color Flange and the Bushing in the Aluminum plate Remove the shipping Plugs from the back and front of the MRI Unit. The MRI Unit is now ready for use.
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RA-MR™ Operator’s Manual Thornhill Research Inc. 10.3 EMOVING UNIT FROM STAND FOR SHIPPING FOR CALIBRATION AND MAINTENANCE WARNING: REMOVAL OF THE MRI UNIT FROM THE STAND MUST BE DONE OUTSIDE THE MRI ROOM. HEX KEYS ARE FERROMAGNETIC. Loosen both holding Screws While holding the MRI Unit with one hand, remove the Screws with the other hand.
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