Please click here to our SOM Pump manual.
Contents
1. o seconds 5 4 Post Study Daily Blow dry Shut down Procedure _ _ Release all pressure in the pump system by disconnecting and reconnecting the metal quick connect on the water reservoir lid several times until the pressure in both gauges on the control box and the gauge on the compressor if included drop to zero Empty all the water in the water reservoir Reconnect the empty water reservoir and pressurize by reconnecting the metal quick connect on the water reservoir lid Open all valves and stopcocks Flush the whole system with air for 5 minutes until no more water is dripping out of the transducers Disconnect and reconnect the water reservoir metal quick connect several times and depressurize the pump system Remove empty water reservoir Store dry with lid off Store pump system dry with all stopcocks and valves open CAUTION Do not leave any water in the pump system or water reservoir overnight Retained water in the pump system may cause the growth of bacteria to unacceptable potable water standards SERVICE MAINTENANCE According to clinical standards the water in the water reservoir has to meet the acceptable levels of potable water The proven method to keep bacterial levels down is to store the pump tubing system dry when not in use The drying protocol alone can maintain the daily sterilized irrigation water wit2. Disconnect and reconnect the water reservoir metal quick connect several times to depressurize Replace used transducers with new PVB transducers Reconnect compact resistors to new PVB transducers For storage Remove empty water reservoir and store dry with lid off For immediate use Fill water reservoir with fresh sterilized irrigation water and continue with start up procedure 24 6 2 Alternate Component Autoclaving Disinfecting Procedure _ A typical SOM pump chemical disinfecting procedure can take up to one and a half hours due mainly to the slow fitting and flushing through the compact resistors with disinfectant and water To shorten the disinfecting procedure time it is recommended that the hospital purchase the optional Autoclavable Components Kit Part P4 S 001 and follow the alternate disinfecting procedures below The Autoclavable Components Kit consists of 3 compact resistors Part P4 H REC060 1 stainless steel manifold Part P4 C 305 and 1 silicone reservoir outflow main tube assembly Part P4 B 601 The advantage of the spare Autoclavable Components Kit is that it will provide uninterrupted usage of the SOM pump while the original set is in the autoclaving process NOTE The PVB transducers are single use and must be replaced after each study The only component that would still require the chemical disinfection would be the water reservoir CAUTION DO NOT autoclave the water reser
3. cccccceceeeceeeeeeeeeeeeeeeeeeeseeeeeeeseneeeeeseeeaeeeseneaeeeseeaanees 14 4 4 Filling Pump and Transducers with Water 15 4 5 Functional Check Pinch Test ss 16 4 6 Calibration of Recording System 16 Section 5 Operation 5 1 Normal Operation Before and During the Study ce cceeeeeeeeeeeeeeeeeeeeneeeseenaeeeeeenaeeeeeeaaes 17 5 2 Functional Troubleshooting with the Pinch Test 19 5 3 Calculation of Pressure Rise Rate 20 5 4 Post Study Daily Blow dry Shut down Procedure 21 Section 6 Service Maintenance 6 1 High level Chemical Disinfecting Procedure 22 6 2 Alternate Component Autoclaving Disinfecting Procedure 00 0 ce cceeeeeceeeeeeeeeseeteeeeeeeaeees 25 6 3 Care and Cleaning of the SOM Pump sienne 26 6 4 Inspecting the Compressor s Drying Cylinder 26 Section 7 Parts List 7 1 Pump Parts List icc fente tenth idl a le Peer mal ee E me fn 28 Section 1 Introduction 1 1 Introduction The Mui Scientific Sphincter of Oddi Manometric SOM pump is part of the motility system used for Sphincter of Oddi manometric studies It is used in conjunction with a computerized motility system and a SOM catheter or the Toouli Sleeve catheter The SOM pump uses regulated compressed air to deliver sterilized water through a compact resistor The pressurized water from each compact resistor passes through a pressure transducer and then proceeds through one lumen s single o
4. SITE INFUSION WATER RESERVOIR PRESSURE RISE ORGAN RATE PRESSURE RATE WITH COMPACT pound square inch AT CATHETER RESISTORS kPa OPENING ml min mm Hg sec UES 15 103 400 Esophagus 15 103 400 Stomach o 15 103 400 sw o 14 Table 2 Pressure Conversion Chart Psi cm of H20 mm of Hg kPa 20 138 15 103 7 48 5 352 259 35 4 4 Filling Pump and Transducers with Water Be sure the water collection tray is placed under the transducers to catch any water that may drip out Ensure the 2 way stopcock to the right of the metal manifold is in the OFF position Ensure all 3 way stopcocks on top of the transducers and 2 way stopcocks below the transducers are open See Figure 4 in Section 4 1 After the water reservoir pressure has been adjusted to 7psi open the main ON OFF 2 way stopcock leading into the right side of the metal manifold Partially unscrew the end plug on the left of the metal manifold to purge any air bubbles that may be trapped at the end of the manifold CAUTION Water will spray out as the end plug is unscrewed Cover the female luer on the manifold with a towel Retighten end plug Allow 2 3 minutes for the water pressure to purge any air inside the compact resistors Ensure the water is flowing out of the top of the transducers and no trapped air bubbles are in the transducers Attach SOM motility catheter to transducers CAUTION If using a Wilson Coo
5. possible cause is a recording system malfunction troubleshoot following manufacturer s instructions B Slow pressure rise in recording Possible causes Air bubbles in fluid path carefully inspect for air bubbles in system If in doubt flush system thoroughly Leakage in fluid path carefully inspect all luer connections for leakage of water Tighten all connections replace any components that leak Wipe all luer connections dry and wait again Supply Pressure gauge too low i e 1 2 psi 19 if the Driving Pressure is less than 7 psi turn the pressure regulator control knob clockwise to increase the pressure output from the regulator to the water reservoir if the pressure on the Supply Pressure gauge is less than 7 psi ensure the medical air hose is properly connected and that there is proper air flow through the system Blocked compact resistor in channels with slow rise rate remove any blocked compact resistors attach the flush support tool around the silicone luer and flush them using a 1cc syringe filled with sterilized irrigation water If any compact resistors are still blocked replace them check that the 3 way stopcocks on top of the transducers are in fully open position disconnect the catheter from the transducers Observe water dripping from each transducer At 7 psi the flow rate should be about 0 4 ml min Leaking or blocked catheter connect the catheter to the transducer and lay it horizon
6. the medical air wall outlet to the red quick connect on the right side of the SOM pump With the air compressor option the black hose from the air compressor is connected to the red quick connection on the right side of the SOM pump The pressurized air can be regulated with the manually adjustable pressure regulator The medical air pressurizes the water reservoir which delivers pressurized water to a manifold and then connects to a set of compact resistors The compact resistors connect to the bottom of the transducers located on the top of the pump which connects to the SOM catheter The pressurized air is regulated with a manually adjustable regulator the black knob on the front bottom of the pump This sets the final pressure in the water reservoir i e The Driving Pressure gauge left side shows the actual pressure in the water reservoir Refer to Figures 1 and 2 in Section 1 2 The Supply Pressure gauge right side shows the pressure from the compressed air supply from the compressor or wall outlet The water reservoir is removable simply resting between the black pegs which sits atop the control box The chamber float acts as a barrier to minimize air absorption into the water under pressure The lid of the water reservoir is removable to facilitate filling and cleaning The 2 way stopcock on the right side of the metal manifold provides the main on off control of the water flow to the manifold The outlet of the manifold is conne
7. Check that there is sufficient water in the reservoir to complete the study Refill the water reservoir if necessary The Driving Pressure gauge should be set at 7 psi The SOM catheter should be firmly attached to the stopcocks on the top of the transducers and all air bubbles should have been flushed out Calibrate the recording system if necessary Refer to Section 4 6 Calibration of Recording System and see instructions from the manufacturer of the motility computer system Make sure that all the tracings are at 0 pressure baseline position Run the computer as for a motility study Set the baseline tracing to 0 This establishes the true hydrostatic baseline of 0 pressure With the pump ON all tracings should show an increase from the baseline of 2 10 mm Hg This is known as the infusion artifact It is caused by friction and restriction of the water flow passing through the catheter If an abnormally high infusion artifact occurs blockage may have occurred within the motility catheter Refer to Figure 5 below Set the infusion baseline tracing to 0 again This is the infusion baseline the baseline pressure with the infusion artifact removed This is the baseline to be used for the study Pinch Test Pinch the motility catheter immediately above the transducer and observe a sharp rise in the tracing Repeat the pinch test to all channels If the tracing does not rise sharply full scale refer to Figure 6 below the SOM pump and
8. SOM Pump Sphincter of Oddi Manometric Pump Operating and Service Manual For Model PIP 5 2SS CE 0120 Bol co ain ill C Mui Scientific EC REP 145 Traders Blvd E Unit 33 34 Advena Ltd Mississauga Ontario Canada L4Z 3L3 Pure Offices Plato Close Warwick Tel 905 890 5525 CV34 6WE United Kingdom Toll Free 800 303 6611 Fax 905 890 3523 Email mail muiscientific com Website www muiscientific com Manual P4 J 101 Rev 4 Federal law U S restricts the sale of this device to or by the order of a physician OUT PRESSURE Sphincter of Oddi Manometric Pump and Air Compressor A READ ENTIRE MANUAL BEFORE OPERATING SOM PU MP Table of Contents Section 1 Introduction 1 1 INO DUCUONS 5 225 2 nr E romanes np entendent den anne Ted az le ste On 4 1 2 FIQUreS st nr nue nee ne rene Rae antenne nie ada dai 6 Section 2 Description of Pump 2 1 Physical Descon nenir er mnt Moine smihran ee tea nt ss 9 2 2 General Requirements Errr r nern r nE rErE errn rnern 10 Section 3 Initial Installation 3 1 Initial WA PACKING x se aae a E E nr eat 11 3 2 Assembly of SOM PUM Dera nir a a E AT Aie EE EE EERE E RIITAA 11 Section 4 Preparation Procedures 4 1 Filling the Water Reservoir inussciidriii iia erii iiia 13 4 2 Connecting Medical Air Outlet Compressor 14 4 3 Adjusting Water Reservoir Pressure
9. ant which is compatible with flexible endoscopes will be compatible with the SOM pump Note DO NOT autoclave the water reservoir damage may result to the plastic components Step 1 Purge system with air approx 5 10 minutes Skip Step 1 when starting with a dry pump Depressurize system by disconnecting the reconnecting the metal quick connect on the water reservoir lid several times until the pressure in both gauges on the control box and the gauge on the compressor if included drop to zero Empty the water reservoir Reconnect the empty water reservoir and reconnect the top and bottom quick connect to the water reservoir to pressurize 22 Purge the whole system with 7 psi air for 5 10 minutes or until no more water is dripping out of the compact resistors Step 2 Fill system with disinfectant approx 50 minutes includes 30 minutes disinfectant soaking time Disconnect and reconnect the water reservoir metal quick connect several times and depressurize the system Fill water reservoir 1 3 full with disinfectant and swirl within water reservoir to rinse all surface area including underside of lid Replace lid and reconnect water reservoir top and bottom plastic quick connect to pressurize Perfuse at 7 psi through pump tubing system for 20 minutes allowing the disinfectant to drip out through the compact resistors into a container Allow the disinfectant to sit within the system for the additional
10. caused by muscle contractions The SOM pump is a constant pressure pump The flow rate is only a function of fidelity of the rise rate The pressure rise rate of the pump measured as pressure change per unit of time i e mmHg sec varies directly with the water reservoir pressure A higher water reservoir pressure will produce a higher pressure rise rate but also a higher flow rate To achieve measurement accuracy the pressure rise rate of the recording system must exceed the actual physiological rise rate of the organ being studied The recommended water reservoir pressure for the Sphincter of Oddi is 7 psi with a flow rate of 0 4mL min The pump allows the operator to change the water pressure for different physiological applications in order to optimize the pressure rise rate and flow rate An infusion rate table is provided Section 4 3 Adjusting Water Reservoir Pressure to enable an estimate of the total volume 4 of water infused into the patient in a given period of time The lower water reservoir pressure and lower pressure rise rate still permit reliable measurement accuracy of the Sphincter of Oddi which has a lower physiological contraction rate of less than of 120mmHg sec This also minimizes the volume of fluid bring perfused 1 2 Fiqures Figure 1 Front View Figure 2 Side View Figure 3 Back View Section 2 Description of Pump 2 1 Physical Description 0 The yellow medical air hose attaches from
11. cted to the compact resistors which connect to the bottom of the transducers The 2 way stopcock at the bottom of the transducers function as individual shut offs for each of the transducers The SOM catheter is connected to the top of each transducer Refer to Figure 2 in Section 1 2 The top 3 way stopcock allows the sterile water to flow through the transducer and into the SOM Catheter or Sleeve The top 3 way stopcock should have the handle point to the side luer outlet This ensures the water flow through the transducer to the catheter Caution Do not turn the top stopcock handle downward toward the transducers This will turn off the flow of water and the full pressure of the SOM pump will be applied to the transducer Damage to the transducer may result 2 2 General Requirements _ The SOM pump should be positioned at approximately the same height as the patient s bed The height of the transducers should be level with the height of the patient s stomach This will reduce the hydrostatic pressure artifact on the transducer and on the recording CAUTION gt No electrical equipment should be located beneath the SOM pump Some water from the SOM catheter is likely to drip down during the procedure A danger of electric shock could result gt Use only sterilized irrigation water in the water chamber or sterilized distilled water Never use tap water as it contains minerals which can cause blockages in tubng and or can support bacterial g
12. egeneration is needed To Regenerate Desiccant e Remove the lid of the air compressor housing Remove the drying cylinder from the air compressor 26 Unscrew the cylinder cap CAUTION The cap is spring loaded Pour out the granules on a tray and spread evenly one granule deep Heat the granules for 5 hours at 125 C 250 F in a conventional oven When all the water has been driven out the granules will be orange again To ensure maximum effectiveness of desiccant do not regenerate more than five times Cool the desiccant in a tight container before refilling the drying cylinder Pre dry the felt filters at 100 C for 30 minutes before assembly of the drying cylinder Reassemble the drying cylinder and connect to the air compressor Pressurize the pump and check that the cap of the drying cylinder is on tightly with no leakage Reconnect to the SOM pump 27 7 1 Replacement Parts List Section 1 Parts List Pump Parts List Part Number Description P4 D 222T PVB Transducer P4 H RECO60 Compact Resistor 0 60ml min P4 B 600 Medical Air Hose 9ft P4 A RES Water Reservoir 500ml with fittings P4 C 551 Open Flow Male Connect with O ring P4 C 601 2 way Stopcock P4 H 304 Flushing Connecting Tube 3 Transducers P4 H 306 Reservoir Draining Tube with 2 way Stopcock P4 B 601X Silicone Reservoir Outflow Main Tube Only P4 C 305 3 Gang Metal Manifold P4 C 545X Wate
13. embly MOTILITY CATHETER aie COMPACT RESISTOR 13 4 2 Connecting Medical Air Outlet Compressor 0 Connect the yellow medical air hose to the red quick connect on the right side of the SOM pump The two metal fittings must be pushed together until they snap into the latched position With the other end of the yellow medical air hose connect the nut fitting to the medical air outlet on the wall NOTE At this point the water reservoir will become pressurized The hose end is a universal fitting an adaptor from the BioMed Department may be required to convert it into your hospital standard fitting Optional If using an air compressor attach the black extension tube from the compressor to the red quick connect on the right side of the SOM pump Push the two metal fittings together until they snap into the latched position NOTE SOM pump will not be pressurized until air compressor is turned ON 4 3 Adjusting Water Reservoir Pressure To select water reservoir pressure for optimal recording accuracy of pressure rise rate for your recording site or organ refer to Table 1 below and adjust the water reservoir pressure accordingly 7 psi is the recommended pressure for sphincter of oddi studies CAUTION Do not set water reservoir pressure higher than 10 psi Patient will receive excessive water Table 1 Water Reservoir Pressure Selection vs Infusion Rate Pressure Rise Rate RECORDING APPROXIMATE RECOMMENDED MINIMUM
14. ft to right Ch 1 Red Proximal Ch 2 Yellow Distal and Ch 3 Black Inthe 2 channel model Ch 1 Red Proximal and Ch 2 Yellow Distal For SOM pumps equipped with PVB transducer holders Remove the transducer holders by unscrewing the 3 thumb screws on top Slide a PVB transducer downward into each transducer holder with the blue cord pointing down until it clicks into place Slide all 3 blue transducer cables into the slot on the pump housing with the blue connectors hanging out the back Secure the transducer holders back into place with the 3 thumb screws on top For SOM pumps equipped with Universal transducer holders Depending upon type shape of transducer install as per the diagram below HOLDER HEX SUPPORT BAR iui High N KNURLED SCREWS __ FRONT BRACKET a b DISPOSABLE SMALL DIAMETER LARGE DIAMETER TRANSDUCER TRANSDUCER TRANSDUCER 11 Connect transducer cable connectors to corresponding channel cable that lead to your computer motility system Attach the compact resistor to the bottom of the transducer female luer and to the top of the metal manifold male luer Place the water reservoir onto the top housing of the SOM pump so the bottom plastic luer sits in between the two pegs on the left Connect the silicone reservoir outflow main tube assembly from the white plastic luer at the bottom of t
15. he water reservoir to the right end of the metal manifold Connect the black hose from the pressure regulator to the metal quick connect on the lid of the water reservoir Push the two metal fittings together until they snap into the latched position 12 Section 4 Preparation Procedures 4 1 Filling the Water Reservoir 0 Ensure that the 2 way stopcock on the right side of the metal manifold is in the OFF position Ensure the 3 way stopcocks on top of the transducers and the 2 way stopcocks below the transducers are open as shown in Figure 4 below Unscrew the knob of the water reservoir and remove the lid and round float by tipping the water reservoir on its side Ensure that the inside of the water reservoir is clean Fill three quarters full with sterilized irrigation water only Replace the float in the water reservoir to avoid any bubbles being trapped under the float CAUTION Never use the pump without the float in the water reservoir Air bubbles will form at the transducer and will reduce the pressure rise rate and the accuracy of measurement Replace the lid and screw the knob back on and tighten securely Ensure the bottom plastic luer located at the bottom of the water reservoir is connected Ensure the top metal quick connect located on the lid of the water reservoir is connected by pushing the two metal fittings together until they snap into the latched position Figure 4 PVB Transducer and Stopcock Ass
16. hin acceptable potable water standards 21 Section 6 Service Maintenance 6 1 High level Chemical Disinfecting Procedure The SOM pump is designed specifically to perfuse water into the duodenum only Therefore the requirement for the water is to meet the potable water standard If the daily blow dry procedure is maintained and only sterilized water is used then the potable water standard will be met Therefore high level disinfection between patients is not necessary For good clinical infections control practice the requirement of high level disinfection of the SOM pump system should be determined by the institution s own guideline High level disinfection once every 1 3 months is typical CAUTION Do not use alcohol to clean the water reservoir Alcohol may cause cracks in the water reservoir material CAUTION Do not use any disinfectant or solution in the fluid path of the pump which is incompatible with the following materials silicone acetal acrylic Buna N epoxy adhesive polycarbonate high density polypropylene polyurethane TFE Brass Nickel polyvinylchloride Confirm compatibility of the disinfectant with the disinfectant manufacturer before use Mui Scientific is not liable for any damage to the pump or harm to patients or personnel caused by improper use of a disinfectant or procedure Clinical evaluations have verified the following disinfectants for use Cidex OPA Sporox Il Korsolex Extra A disinfect
17. k Lehman SOM Catheter DO NOT connect the middle Green Aspiration Port to the SOM pump The Green Aspiration should be left open to air or attached to a syringe for aspiration f using a Toouli sleeve catheter the single channel can be attached to any one of the transducers The catheter can be pre filled with a large syringe with sterilized water The pump system is now filled with water and ready for a functional check Fill the catheter with water and flush out any remaining air bubbles until water drips off the catheter 15 4 5 Functional Check Pinch Test It is recommended that this pinch test be performed routinely at the beginning of each motility study This test confirms that the entire system is functioning properly including the pump the transducers and the recording system and gives a permanent record of the functional performance of the system This pinch test is also useful during a study whenever the clinical tracing is abnormally inactive and the performance of the system is in question Run the recording program as you normally would for a motility study Set the recording system pressure amplitude as you would for a study and SOM pump on water dripping out of the catheter Turn the top 3 way stopcock handle pointing downward to the transducer momentarily Then quickly return to the right hand position The pressure tracing should respond immediately with a virtually vertical rise to the full scale
18. length of time recommended by the disinfectant manufacturer 30 mins or longer is common for high level disinfection Step 3 Purge system with air again Depressurize by disconnecting and reconnecting the water reservoir metal quick connect several times Empty water reservoir and rinse with sterilize water Reconnect empty water reservoir and reconnect the metal quick connect to pressurize Purge system with 7 psi air for 20 minutes or until no more disinfectant is dripping out of the compact resistors and transducer Step 4 Rinse system with sterilized irrigation water approx 25 minutes Disconnect and reconnect the water reservoir metal quick connect several times and depressurize system Remove water reservoir Rinse with sterilized irrigation water Fill water reservoir 1 3 with sterilized irrigation water Replace lid and reconnect water reservoir top and bottom plastic luer and to top metal quick connect to pressurize Perfuse at 7 psi for 20 minutes to rinse disinfectant Open all stopcocks to rinse Step 5 Purge system with air again for storage or immediate use Depressurize by disconnecting and reconnecting the water reservoir metal quick connect several times Empty water reservoir Reconnect empty water reservoir to bottom plastic luer and top metal quick connect Purge tubing system with 7 psi air for 20 minutes or until no more water is dripping out of the compact resistors 23
19. lter Make sure all components are dry and free moisture inside by flushing compact resistor with air using a large syringe Pack these components for autoclaving 3 After autoclaving attach a new sterile 2 way stopcock and a new water filter to the silicone reservoir outflow main tube Re assemble all the components onto the SOM pump Refill the water reservoir with sterile irrigation water and flush the entire system for five 5 minutes 6 Now the system is disinfected and ready to be used 6 3 Care and Cleaning of the SOM Pump Use a soft cloth moistened slightly with water and mild soap to wipe down any spots that may accumulate on the outside of the pump Wipe off any soap residue with sterilized irrigation water Rinse out the water reservoir with fresh clean water and wipe out using a soft cloth DO NOT USE ALCOHOL 6 4 Inspecting the Compressor s Drying Cylinder For SOM pumps using a compressor inspect the drying cylinder through the port on the back of the air compressor If the color of the drying cylinder is orange the desiccant is in satisfactory condition If the color of the entire drying cylinder is dark green it indicates that the desiccant has absorbed excessive amounts of moisture from the air and it must be regenerated The length of time before the desiccant needs to be regenerated will vary depending on the operating environment and the frequency of pump use The desiccant may last several years before r
20. ng is affected the problem is most likely to be in the individual compact resistor the transducer or the SOM catheter If all channels are affected then the problem is probably with the water reservoir or the recording system To ensure measurement accuracy of the physiological contractions for SOM studies the pressure rise rate should be 120 mmHg sec or better A No pressure rise in recording Possible causes Supply Pressure or Driving Pressure is abnormal if the Supply Pressure gauge is zero check the yellow medical air hose to ensure both ends are connected properly if the Driving Pressure gauge is less than 7 psi adjust it to 7 psi Top quick connect to water reservoir is disconnected or water reservoir is not pressurized make sure that the metal quick connect on the side of the water reservoir lid is connected properly Push the connector together hard until it snaps Bottom plastic luer to water reservoir is disconnected reconnect the bottom plastic luer Main ON OFF 2 way stopcock on compact resistor transducer SOM catheter is closed open stopcock to correct the problem Transducer malfunction if any individual channel has a poor or no response rate then there could be a transducer malfunction interchange the transducer of a poor response channel with one from a channel that is responding properly to confirm malfunction Recording system malfunction if all channels have no response then the
21. or computerized recording system are not functioning properly Troubleshoot the problem before proceeding with the study Section 5 2 Functional Troubleshooting with the Pinch Test If the tracings are acceptable the SOM catheter can be placed into the holding tube directly below the metal manifold until the patient is ready for insertion or it can be immediately inserted into the patient through the biopsy channel of the endoscope You can repeat the pinch test again or start the motility procedure according to your protocol 17 Figure 5 Infusion Artifact FIRST SECOND BASELINE BASELINE SET SET INFUSION START PINCH TEST mmH INFUSION OFF INFUSION ON Figure 6 Pinch Test Normal and Slow Pressure Rise Rate 3 sec NORMAL 120 mmHg 50 I 5 4 sec 10 sec a VAS DI ADA SLOW SLOW 18 5 2 Functional Troubleshooting with the Pinch Test When the tracing following the pinch test does not rise sharply to full scale deflection the system is not functioning properly If only one traci
22. pening or sleeve into the Sphincter of Oddi of the patient The pressure changes in the sphincter or bile duct are transmitted through this fluid path back to the externally mounted transducer on the SOM pump i e the water serves as a pressure transmission medium Each lumen of the motility catheter is connected to its own pressure transducer and all the pressure transducers are connected to a computerized recording system The computer will display the pressure waveform on the monitor and generate analysis report The pressure profile of the 1 or 2 channel tracing provides useful diagnostic data for evaluation of the normal or abnormal motor function of the Sphincter of Oddi according to pressure amplitude and cycle per minute Basal pressure of 40 mmHg or higher is considered abnormal This SOM pump provides a high static hydraulic pressure background at 7 psi to ensure a high pressure rise rate as well as recording accuracy and repeatability It can record the fast pressure changes of the Sphincter of Oddi and will ensure a minimum of 120 mmHg per second rise rate The small bore of the compact resistor also ensures a very low infusion rate of 0 4mL min This will minimize the amount of water entering the bile duct The Toouli SOM sleeve is a reversed sleeve all the water is discharged into the duodenum and no fluid enter the Sphincter of Oddi or bile duct During a motility study the actual flow rate varies due to the varying amount of obstruction
23. pressure amplitude as set This response confirms that the entire system is functioning properly with no leakage or major trapped air bubbles in the system Caution Prolonged pressure may cause damage to the transducers To check performance of catheter use finger to pinch end of sleeve or opening Refer to Section 5 2 Functional Troubleshooting for detailed explanations of unsatisfactory pressure tracings and to Section 5 3 for Calculation of Pressure Rise Rate Repeat this test for all channels The pump is now in standby mode ready for calibration 4 6 Functional Check Pinch Test Refer to the manufacturer s instructions for your computerized data processing system Follow the recommended calibration procedure Use of Hydrostatic Calibration System 0 68 cm H20 With pump ON and water dripping slide catheter into the bottom calibration tube The bottom calibration tube is fixed to the same height as the transducers This position simulates 0 cmH20 or 0 mmHg pressure Select low calibration on computer or adjust baseline on recorder to 0 cmH20 or 0 mmHg position for each channel Slide catheter into the top calibration tube This position generates 68 cmH 0 or 50 mmHg pressure Select high calibration on computer or adjust the recorder to 68 cmH 0 or 50 mmHg for each channel The pump is now calibrated and in stand by mode ready for a study 16 5 1 Section 5 Operation Normal Operation Before and During the Study 0
24. r Filter 20 microns P4 P 503 C clamp for IV Pole P4 F 203 204 Air Compressor P4 CONBOX Regulator Control Box P4 H 640 Calibration system Scale 0 68 cmH 0 or 0 50 mmHg P4 D 400 Water Collection Tray Autoclaving Components Kit Part Number Description Part Illustration Autoclavable Components Kit P4 S 001 3X Compact Resistors 0 60ml min 1X Stainless Steel Manifold 1X Silicone Reservoir Outflow Main Tube Only 28
25. rowth Electrical requirements for Air Compressor Unit if included a 115 Volt Model A grounded hospital grade 115 Volt 60 Hz 15A electrical outlet is required The pump is rated at 2A Hospital grade power cord with IEC plug is included b 220 Volt Model A grounded hospital grade 220 Volt 50 Hz electrical outlet is required The pump is rated at 2A Hospital grade power cord with female IEC plug is required c 240 Volt Model A grounded hospital grade 240 Volt 50 Hz electrical outlet is required The pump is rated at 2A Hospital grade power cord with female IEC plug is required 10 Section 3 Initial Installation 3 1 Initial Unpacking Remove any remaining packing material Place the main pump assembly on a table Unpack the following Calibration Rod with 2 tubes and 2 thumb screws Water Collection Tray Compact Resistors Package of 3 Water Reservoir Silicone Reservoir Outflow Main Tube Assembly Yellow Medical Air Hose Disinfectant Flushing and Draining Kit 3 2 Assembly of SOM Pump Attach the accessories in the following order refer to Figures 1 to 3 in Section 1 2 Place the calibration rod against the left back of the pump and secure the rod to the pump using the 2 thumb screws provided Slide the calibration tubes onto the upper and lower holders on the rod Place the water collection tray in the left bottom tray holder Ensure the 3 transducer holders are labeled accordingly from le
26. tally on top of the transducers the artifact should be similar for all channels any channel that has an unusually low infusion artifact is likely to have a leaking lumen or valve connection Repair or replace leaking component any channel that has an unusually high infusion artifact is likely to be blocked in that lumen of the catheter Remove the catheter place it in a basin of hot water and flush the channel with a small syringe and hot water until the channel is cleared 5 3 Calculation of Pressure Rise Rate The pressure rise rate is defined as the pressure rise rate in mmHg or cmH 0 per second Run the recording system at a high speed such as 15 mm sec in order to capture a one second slope With infusion on block the opening of the SOM catheter with your finger to create a rise in pressure For the Toouli sleeve catheter block the sleeve at the proximal end Do not hold the sleeve for an excessive length of time The high pressure from the SOM pump could damage the sleeve The pressure tracing in the figure rises from 0 mmHg at the beginning of the rise to 410 mmHg at the 1 second mark The pressure rise rate is therefore 410 1 410 mmHg sec To ensure measurement accuracy of the physiological contractions the pressure rise rate for Sphincter of Oddi studies should be 120 mmHg sec or better 20 Figure 7 Calculation of Pressure Rise Rate
27. voir damage may result to the plastic components A Water Reservoir Disinfecting Procedure 1 Remove water reservoir from the pump deck and empty water out Connect the reservoir draining tube to the bottom of the water reservoir with the 2 way stopcock in the CLOSED position 2 Fill one third of the water reservoir with Cidex OPA Close lid and swirl the disinfectant within the water reservoir to rinse all surface areas including the underside of the lid Open the 2 way stopcock of the reservoir draining tube to fill the reservoir draining tube with Cidex OPA and then close the 2 way stopcock 3 Allow the disinfectant to remain in the water reservoir according to the disinfectant manufacturer recommended soaking time 30 minutes or longer is common on high level disinfection 4 Empty out all the disinfectant from the water reservoir and fill it two third full with sterile irrigation water Close lid and swirl water in the water reservoir to rinse all surface areas including the underside of the lid Open the 2 way stopcock of the reservoir draining tube and drain all the water out of the water reservoir 5 Repeat Step 4 three 3 times The water reservoir is now high level disinfected 25 B Compact Resistors Stainless Steel Manifold Silicone Tubing Autoclaving Procedure 1 Remove compact resistors stainless steel manifold silicone reservoir outflow main tube from the SOM pump Discard the 2 way stopcock and water fi
Download Pdf Manuals
Related Search