Standard Operating Procedure
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1 Standard Operating Procedure Equipment / Procedure: Filename: Assessor s name & date: Reviewer s name & date: Cosmed K SOP_cosmed_K4 Richard Metcalfe, December 2012 Tom Nightingale, December 2012 Review Date: December 2014
2 Cosmed K4 Safety Information Ensure that you have had appropriate training and have read the relevant operator s manual/s and any specific documentation prior to using the equipment or undertaking the following task. Prior to using the Cosmed K4 you should refer to the following risk assesements: o RA_mouthpieces_and_facemasks o RA_expired_gas_analysis Charging the Batteries It is recommended to charge batteries before each test. When the batteries are low the warning message is prompted on the K4 (2 beeps = ½ charged battery 3 beeps = discharged battery) 1. Insert the batteries into the places on the top of the K4 as shown below. 2. The small green LED placed on the front panel warns the charge in progress. The battery is charged when the LED starts blinking. Warm Up 1. Connect the K4 unit to the Charger Unit and turn both units on. Place the 3 rechargeable batteries on top of the unit. The small green LED placed on the front of the panel warns the charge in progress. The battery is charged when the light signal placed on the front panel of the Charger Unit starts blinking.
3 (Always keep the K4 unit in its upright position by placing it on its metal stand) (ALWAYS supply K4 exclusively by the Charger Unit during warm up). 2. Allow at least 45 min warm-up time (recommended = 60 min). NB Supply the K4 with the Charger Unit for warming-up only. Calibration The system must be calibrated according to the following procedures: 1. Room Air Calibration 2. Reference Gas Calibration 3. Delay Calibration 4. Turbine Calibration Calibration can be run using either the K4 portable unit or the PC software. It is recommended that you use the PC software. Room Air Calibration 1. Connect the K4 to the PC by the serial port. Remove the sampling plug from the flowmeter. 2. Select Test Calibration Calibration - Room Air 3. The message Room air calibration in progress. Will appear and a graph will show the O 2 and CO 2 calibration in real time. At the end of
4 the calibration the message Calibration done will appear. Press OK to confirm calibration results when the dialogue box appears 4. Best practice during room air calibration would be to take a sample of the room air using the nearest permanent gas analyser and input these values. However, this may not always be possible. Reference Gas Values 1. It is suggested to use 4.93 % CO 2 and % O 2 concentrations and N 2 for balance. 2. Before calibrating ensure the Reference Values of room air and reference gas are properly entered both in the K4 and PC software. 3. Connect the K4, calibration unit (stored permanently in UBSA lab in cupboard next to reference gases) and gas cylinder as shown below: 5. Open the cylinder valve ensuring the pressure is within a range of psi (3-5 bars) (CAUTION: High Pressure). At this time keep the valve on the high pressure tube attached to the Calibration Unit in its closed position. 4. Ensure the sampling pug is removed from any unit as the software first runs a room air calibration 5. Run the calibration program in the PC software and choose Gas from the Calibration menu. If you do not have access to a PC then calibration can also be run from the unit.
5 6. The message Gas calibration in progress will appear and a graph will show in real time the O 2 and CO 2 calibration. 7. When the message Sample reference gas appears connect the sample plug to the Calibration Unit and open the valve on the high pressure tube. 8. At the end of the procedure the message Calibration done will be seen. 9. The dialogue box displaying the calibration results will appear, press OK to confirm the calibration. 10. Make sure the cylinder is closed and the valves on both the cylinder and high pressure tube are also closed. Gas Delay Calibration 1. Ensure the sampling plug is removed from any units. 2. Run the calibration program and choose Delay from the Calibration menu. 3. The message Gas calibration in progress will appear and a graph will show in real time the O2 and CO2 calibration. The software first runs the Room Air calibration. At the end of the Room Air calibration the following message appears: Connect the sampling line to the flow meter and press OK button to continue 4. Connect the sampling tube to the optoelectronic reader (see figure under Turbine Calibration section) and press OK button to start breathing at a constant rate. 5. The software helps to maintain a constant rate by means of a beep sound. It is not important to maintain the same rate suggested by the system but it is very important to breathe consistently. It is recommended that you try and inspire on 1 beep followed by expiration on the next and so on. 6. Continue breathing until the message Calibration done appears. The software opens a dialogue box with the new calibration factors and the new delay value. Press OK to confirm the calibration.
6 Turbine Calibration 1. Connect the Optoelectronic reader to the calibration syringe (which is usually kept in the cupboard underneath the Servomex and reference gas bottles in UBSA) through the adapter. 2. Connect the flow meter to the syringe with the rubber cylinder supplied in the standard packaging. 3. Select Reference Values from the File menu. If the syringe you are using is different to the default one (3 litres), please enter the correct value. 4. Select Calibration/Turbine. 5. When the Calibration Turbine dialogue box appears with the syringe piston initially pushed all the way in, move the piston in and out for 5 inspiratory strokes and 5 expiratory strokes in order to get the values appearing on the display. Then move the syringe piston for another 10 strokes (IN and EX). 6. At the end of this procedure, the software displays the new calibration factors. Press OK to store the new value. Checking the System Signals The Control Panel, which can be activated from the Calibration/Control panel. menu item, is a useful tool to check the main hardware functions of K4 b 2. After the calibration it is useful to check atmospheric O 2 and CO 2 concentrations.
7 Running a Test There are 3 options when running a test: Holter Data Recorder Mode Telemetry Data Transmission Mode Serial Mode Assemble the K4 1. Plug the turbine in the mask adapter by pushing and rotating it clockwise until you feel a stop. 2. Insert the optoelectronic reader over the turbine and press it into the mask. 3. Plug the wind cover as described in point Plug the sampling tube into the little hole located in the optoelectronic reader. 5. Plug the turbine cable in the turbine plug control panel of the K4
8 Holter Data Recorder Mode 1. Warm up the K4b2 for 45 mins before testing or calibrating 2. From start menu on the unit scroll down to no.3 Test option and press enter 3. Then select patients data and enter the information for the fields below using the UP and Down Keys to modify values. # Patient ID A age in years H height (cm or inch) W weight (kg or lbs.) S sex (M or F) HR HR max 4. The HR max is automatically calculated by the formula 220 minus age, however it can be changed. Calibrate and Start the Test 1. Again, before connecting the K4 to the subject remove the sampling plug from the mask. And put the tube far from expired gas concentrations. 2. On the Patient s Data menu scroll down the menu and select Start Test from the main menu and press Enter to confirm. 3. The message Insert relative humidity will be seen, type the correct value and press Enter. 4. The K4 runs automatically the Room Air calibration. The message Do not breathe near the sampling line appears. Wait for few seconds until the message Calibration done will appear together with a double beep sound. 5. Connect the sampling plug to the optoelectronic reader and then to the subject (see figure on next page). Some values will be shown and updated each breath on the control panel display. The message Press Enter to start the test will be displayed each 10 s. You can switch to different values by moving up and down.
9 6. One you press the Enter key the test starts but he K4 is not storing data. In this phase the unit is checking the main parameters and you can visualise it on the K4 display by the time blinking. 7. To start storing data press the Enter key again. You can check the storing phase because the timer doesn t blink anymore. Stop the Test 1. To stop the test press Cancel. The message Press enter to stop test will appear, press Enter to stop the test. 2. Disconnect the subject from equipment. Transferring test to PC 1. Turn the K4 on. 2. Connect the K4 to the PC by the serial cable. 3. Run the K4 software and choose Receive Test from the Test menu. 4. To download a test you must link it to an existing patient file. Choose Find and then List to select an existing patient. If the patient is new
10 then select Find and then New, fill in the fields and press OK to confirm. 5. Select the test to link by using First, Previous, Next and Last buttons and press Download to confirm your choice and to store the test on your hard drive. You can use the Preview button to see some data and graph of the test in order to find out the proper one. Cleaning and Sterilisation Sterilise the facemask in Milton solution for 30 min, rinse the head net harness and heart rate transmitter belt in soapy water. Hang up to dry. To clean the turbine, simply leave it in the Milton solution for 30 min and then rinse it in a tub of clean water by shaking it gently. DO NOT PUT THE TURBINE UNDER RUNNING WATER!! End of Document
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