8700-0001-000 Rev4 ISU Service Manual.indd
Contents
1. PTS ISU 8700 1251 900 1271 7251 7271 PTS ISU Digital 8700 1351 900 1371 1372 7351 7371 7372 2 1 ISO Vacuum Regulator Analog Digital Note Part numbers given are for Vacuum Regulators without fittings or adapters probes PTS ISU PTS ISU Digital 8700 1253 900 8700 6353 900 1273 6373 6372 Figures 1 3 1 Description A WARNING Do not use this device in the presence of flammable anesthetics Static charges may not dissipate and possible explosion hazard exists in the presence of these agents The PTS ISU is a dual purpose vacuum regulator which provides either intermittent or continuous suction It can be used for NG drainage intermittent or pharyngeal tracheal continuous suctioning throughout the hospital A patented safety feature Push To Set PTS automatically occludes the patient circuit as the desired vacuum level is selected It prevents higher than desired vacuum levels from being accidentally delivered when patient suctioning begins The suction control knob must first be pushed and then turned to set vacuum levels Each unit contains a dual spring regulator module to regulate and adjust suction which is precise in the critical care range 0 200 mmHg 26 7 kPa and quickly moves to full wall vacuum for resuscitation It requires only two turns from zero to full wall vacuum Each unit contains a vacuum gauge an ON OFF switching module and adjusta2. lt lt lt lt w wswweeeewana 2 2 2 ISO Vacuum Regulator lt lt lt lt lt lt lt w wweewemaamesa 2 3 Description and Specifications Bll DESCIDTON AA anaiai aain 2 3 2 SPECHICALIONS Aiissssecccvasheneccaradadeccaataccdtccasacceetdaats 3 4 Operation 4 1 Equipment Setup cceeeeseeeceeeeeeeeeeseeeeeeeeees 4 4 1 1 Attaching the OST n a 4 4 2 Mode Selection ccccccceccseecceeesseteeeeeessteeeeesees 5 4 3 Setting the Suction Level w w wmwa 5 4 4 Pre Use Checkout Procedure lt w 5 4 5 Patient SOUP ia 6 5 Cleaning and Sterilization 5A GIGANING isinira loti den 6 5 1 1 Routine Exterior Cleaning lt lt lt 6 5 1 1 1 Approved Cleaning Solutions 6 5 1 2 Internal Component Cleaning 7 5 1 2 1 Approved Flush Solutions 7 5 1 3 Cold Flush Procedure w wwwwwa 7 5 2 DISIMNTECUION ka kai 7 6 TroubleShOOting 8 7 Service Disassembly and Assembly 7 1 Service Tools and Eguipment w w ewa 11 7 2 PTS ISU Disassembly Assembly 11 7 2 1 Disassembly ia 11 Tae ASSOMIDLY AA AA 12 7 3 Regulator Module www wwmammmaammmzaza 13 7 921 Disasie mbya 13 LAS IA 13 7 4 Timing and Flow Control Valves 13 TAA Disassembly cienie 13 7 4 2 ASSOMDIY ccee
3. s recommendation for specific aeration periods required A CAUTION Do not steam autoclave or liquid sterilize the PTS ISU Severe impairment to the operation of the regulator will result A CAUTION Disinfection with ethylene oxide mixtures may cause crazing minute superficial cracking of some plastic parts Note The PTS ISU should only be disinfected if it is contaminated or maintenance is to be performed 1 The regulator should be disinfected with the mode selector switch in the O O INT position 2 Ethylene oxide mixtures can be used at temperatures of 125 to 135 F 52 57 C If this temperature cannot be obtained room temperature sterilization with 100 ethylene oxide can also be used Disinfection is NOT recommended as a frequent procedure 3 After each disinfection check the condition of the internal filters Replace any shrunken filters continuous and intermittent circuits with vacuum flow or compressed air until all internal channels switches gauge ports and regulating mechanisms are dry 4 Perform Service Checkout Procedure Section 8 Disassemble to check O rings for adequate lubricant and filters for proper function following any cold flush procedure Perform Service Checkout Procedure Section 8 before returning the regulator to service 7 8700 0001 000 Rev4 6 Troubleshooting Place the regulator in the vertical position and connect to a supply vacuum of 500 mmHg 66 7 kPa Problem
4. 4 Check that the regulator gauge reads between PTS ISU 80 mmHg 10 7 kPa and 100 mmHg 13 3 kPa when the knob is pushed 8 8 Vacuum Buildup Bleed down Test Intermittent Mode 1 Turn the mode selector switch to IOIO INT 2 Connect the regulator fitting port to the 1500 ml suction canister with lid 3 Push and rotate the knob to set 120 mmHg 16 kPa 4 During the ON cycle check that the suction increases to the preset 120 mmHg 16 kPa on the regulator gauge in 5 seconds or less 5 During the OFF cycle check that the suction decreases to zero on the regulator gauge zero stop pin in 5 seconds 6 If the regulator fails either the build up or bleed down test replace the regulator module 8 9 Bleed Test 1 Turn the mode selector switch to CONT 2 Push and rotate the knob to set 120 mmHg 16 kPa 3 Turn the mode selector switch to O OFF and observe the gauge needle It must return to zero within 10 seconds 8 10 Leak Test Patient Side 1 Turn the mode selector switch to O OFF 2 Connect the regulator fitting port tubing to port A of the bubble leak tester Keep port B open to air Push and rotate the suction control knob fully counterclockwise decrease Turn the mode selector switch to CONT Wait 5 seconds No bubbles should appear in the bubble leak tester for the next 10 seconds Fitting Patient Port Figure 12 Bubble Leak Test pat
5. Overflow Safety Trap assemblies and disposable suction filters will protect the regulator wall outlet and piping system The flow rate at the wall outlet should be checked on a yearly basis and suitable cleaning of the outlets should be performed as needed The flow rate measurement should meet NFPAQ9 and or ISO standards We recommend the following to determine the maintenance schedule appropriate for each facility Periodically as required but no less than annually inspect the overall condition of the vacuum regulator Test gauge accuracy section 8 6 Gauge Test and perform the Pre Use Checkout Procedure section 4 4 If the regulator does not pass refer to Troubleshooting Section Routine maintenance and inspection are important to or the performance of suction equipment The following 2 Determine a maintenance schedule based on is a recommended list for care of suction equipment data from your periodic inspections Follow the after each patient use guidelines below 1 Keep connecting tubing fittings and adapters probes clean 9 2 1 Maintenance Schedule KA Minimum Frequency Comments Service Checkout Procedure Every 24 months or as required If the regulator does not pass refer to Troubleshooting Section 6 Repair as needed Elastomeric parts O rings As required Cleaning lubrication and replacement gaskets diaphragms inter interval depends on hours of usage and en nal filters vironmental condit
6. iii Replace worn drive gear iv Replace cover if worn splines in well v Replace Push To Set assembly 2 Blocked fitting port 2 Unblock port 3 Overflow Protection Device 3 Reset float empty the autoclave Overflow Shut off Protection Device 4 Blocked external filter 4 Replace external filter 5 Blocked fitting 5 Replace fitting 6 Leak in system 6 Remedy i Check lid is secure on the collection container ii Check tubing connections Gauge indication but no suction is being delivered 8700 0001 000 Rev4 8 6 Troubleshooting Problem Possible Causes Remedy E Suction level cannot 1 Failure to push knob and 1 Push and rotate to set vacuum level be adjusted rotate Regulator module is stuck in Rotate knob to un stick full OFF or full ON position Regulator module 3 See Regulator module malfunction under malfunction the Problem column in this section of the manual Suction level can 1 Worn or broken drive gear 1 Replace drive gear be adjusted without 2 Worn or broken splines in 2 Replace cover pushing the knob in well 3 Broken knob Replace knob Insufficient flow 1 Partial blockage in wall Confirm wall supply is open and air flow through regulator supply meets minimum hospital requirements 2 Partial blockage in regulator Perform the Flow Test in the Service Checkout Procedure section of this manual 3 Push to Set spring 3 Remedy assembly does not return i Jiggle knob blocking the fl
7. Possible Causes Remedy A No gauge indication 1 No supply vacuum 1 Correct supply problems and no suction in any 2 Kinked tube 2 Straighten tube setting 3 Check all connections and seals 4 Blocked wall outlet 4 Unblock outlet 5 Blocked adapter probe port 5 Unblock port 6 Blocked backplate 6 Clean with soap and water and a pipe cleaner 7 Regulator module 7 See regulator module malfunction under malfunction the Problem column in this section of the manual 8 Inthe OFF cycle of the IOIO 8 Inthe IOIO mode the regulator starts mode in the ON cycle However if the unit was stopped in the OFF mode and immediately re started it may take about 5 seconds to enter ON mode Depleated batteries Charge batteries Regulator module O ring quad ring or Replace rubber components malfunction diaphragm failure 2 Cap not completely snapped 2 Fully snap cap onto housing to housing 3 Springs are not installed 3 Ensure that springs are properly installed correctly 4 Pinched diaphragm 4 Reinstall or replace diaphragm No gauge indication 1 Blocked gauge pressure 1 Unblock orifice but suction is being sensing orifice delivered 2 Blocked gauge pathway 2 Clear pathway through Unilogic Module Failed gauge o ring seal Reinstall or replace the o ring 4 Gauge mechanism Replace gauge electronics is damaged Knob fails to return when Remedy pushed i Jiggle knob ii Verify actuator is installed properly
8. e 2 97 El 9 pz kigwassy ct ve jnpo Buru ve ce 8700 0001 000 Rev4 io Medical Corporation always there for life North America United States Customer Service Distribution Center Technical Support Sales and Service Equipment Service Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA P 1 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 Ohio Medical Corporation Authorized Representative OxygenCare Ltd 2 Holfeld Business Park Kilmacanogue Co Wicklow Ireland Tel 353 1 2769700 Fax 353 1 2764970 Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA 866 549 6446 847 855 6218 Fax www ohiomedical com 8700 0001 000 Rev4 11 2010
9. off the backplate Remove clean and or replace the Cover Strip To remove the Gauge Assembly and foam grasp and pull straight out Lubricate or change the gauge o rings if needed Remove Actuator and Push To SetTM Assembly To remove the Regulator Module grasp the stud and rotate clockwise Note To disassemble the Regulator Module refer to the Regulator Module Assembly section Remove the Unilogic Module by removing the 2 deep center side screws No 1 Phillips Remove and check beige filter green filter and seven o rings Replace filters if needed Replace or lubricate o rings if needed If needed remove the Timing Valve and the Flow Control Valve with a flathead screwdriver Replace or lubricate the o rings if needed Remove the Detent Plate and the Mode Selector Switch Replace filter if excessive wear or damaged Remove the Gauge Bleed Hole Filter from the Manifold Assembly Replace if needed Grasp the Positive Pressure Relief Valve and pull from the Manifold Assembly Replace if torn or damaged If needed remove the Faceplate as follows a Carefully peel back and remove label from the knob b Disconnect the knob from the Drive Gear by grasping the knob to remove the knob screw c Rotate the Faceplate Collar counterclockwise to remove d Remove the Faceplate Grab pull tab on Vacuum Relief Plug and remove Replace if deteriorated 11 8700 0001 000 Rev4 7 Service Disass
10. portion of valves may be damaged 7 4 1 Disassembly 1 Remove Timing Valve and Flow Control Valve by turning counterclockwise with a flat head screwdriver 2 Replace and or lubricate o rings as needed 7 4 2 Assembly 1 Carefully insert and tighten the Timing Valves 2 Press Flow Control Valve in to engage threads then tighten 3 Rotate each clockwise about 3 turns from thread engagement 7 5 Digital gauge Please Note Both batteries are positioned with the positive side facing up relative to the display 7 5 1 Removal of Batteries 1 Remove digital gauge as described in 7 2 2 2 Using a small flat head screwdriver push batteries out at a 45 angle 7 5 2 Inserting Batteries 1 Place negative side of battery into battery slot first battery will be at an angle 2 Then using a flat head screwdriver gently push in positive battery contact while sliding battery in place 13 8700 0001 000 Rev4 8 Set Up 8 1 Set up 1 Verify there is 500 mmHg 10 mmHg 67 kPa 1 3 kPa vacuum on the supply gauge The supply open flow must be 50 LPM minimum Connect the supply vacuum to the adapter probe port Patient Fitting Port Vacutimer X TE jx y 888 Occlusion O 10LPM 0 50 LPM Flowmeter Flowmeter 1500cc Canister Figure 9 Service Checkout Procedure Setup 8 2 Push To Set Test 1 Connect the 10 LPM Flowmeter to the patient port
11. 2 Set 200 mmHg 26 6 kpa on the gauge and keep the knob pushed in 3 Make certain leakage at the patient port connection is no more than 1 LPM 4 While observing the flowmeter push and rotate the knob Leakage should be no more than 1 LPM Release the knob It should fully return 8 3 Leak Test Supply Side 1 Connect the supply vacuum tubing to port A of the Bubble Leak Tester 2 Connect port B of the Bubble Leak Tester to the regulator adapter probe port 3 Turn the mode selector switch to O Off Allow the fitting port to be open to air 4 Wait 10 seconds No More than 6 bubbles should appear in the next 10 seconds Important Prior to venting port A of the Bubble Leak Tester to atmosphere i e turning the supply regulator off ensure the tubing from port B has been disconnected from the adapter probe port of the vacuum regulator Test Gauge Adaptor Probe Port Figure 10 Bubble Leak Test Supply Side 8 4 Flow Test Remove the Bubble Leak Tester from the supply vacuum connection and connect the supply vacuum directly to the regulator adapter probe port 8 4 1 Continuous Mode Flow Test 1 Connect the regulator fitting port to the 50 LPM flowmeter 2 Turn the mode selector switch to CONT 3 Push and rotate the suction control knob fully clockwise increase 4 Verify the flow rate exceeds 40 LPM 8 4 2 Intermittent Mode Flow Test 1 Remove the face plate
12. Ohio Medical Corporation always there for life Push To Set Intermittent Suction Unit PTS ISU Service Manual ISO PTS ISU Analog ANSI PTS ISU Analog ANSI ISO PTS ISU Analog 8700 0001 000 Rev4 11 2010 User Responsibility IMPORTANT Federal law in the U S A and Canada restricts this device for sale by or on the order of a license medical practitioner A WARNING This device is to be used only by persons who have been adequately instructed in its use A WARNING Do not use this device in the presence of flammable anesthetics Static charges may not dissipate and a possible explosion hazard exists in the presence of these agents This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and or inserts when assembled operated maintained and repaired Product Date Coding AAAA 12345 in accordance with the instructions provided This Product must be checked periodically A defective product should not be used Parts that are broken missing plainly worn distorted or contaminated should be replaced immediately Should such repair or replacement become necessary see the Ohio Medical service manual for service or repairs to this product For service advice Ohio Medical recommends that a telephone request be made to the nearest Ohio Medical Regional Service Center This product or any of its parts shou
13. al information to clarify a point in the text Important An important statement is similar to a note but of greater emphasis A CAUTION A CAUTION statement is used when the possibility of damage to the equip ment exists A WARNING A WARNING statement is used when the possibility of injury to the patient or the operator exists 1 2 Definitions in Hg Inches of mercury in Inch ISU Intermittent Suction Unit kPa Kilo pascals kPa x 7 50 mm Hg LPM Liters per minute mm Hg Millimeters of mercury mm Hg x 133 kPa mm Millimeters OZ Ounces CONT Continuous On IOIO INT Intermittent On Off O Off Off C Degrees Celsius F Degrees Fahrenheit N m Newton Meter N m x 737 ft lb ft lb Foot Pound Force ft lb x 1 356 N m in lb Inch Pound Force ft lb x 12 in Ib DISS Diameter Index Safety System OES Oxequip Suction NCG National Compressed Gases Chemetron BOC British Oxygen Corporation NPT National Pipe Thread USA MPTS Multi Purpose Therapy Stand I D Inner Diameter gal gallon PTS Push To SetTM PTFE Teflon NG Naso Gastric RH Relative Humidity 8700 0001 000 Rev4 2 Scope 3 Description Specifications This service manual contains service maintenance and parts information for the Push To SetTM Intermittent Suction Unit PTS ISU 2 1 ANSI Vacuum Regulator Analog Digital Note Part numbers given are for Vacuum Regulators without fittings or adapters probes
14. any service procedure Supply Vacuum 500 mmHg 67 kPa minimum and 50 LPM open air flow minimum Phillips head screwdriver No 2 Flat head screwdriver 1 4 inch Phillips head screwdriver No 1 Open end adjustable wrench Pipe Cleaner Wooden toothpick O ring remover Tweezers Filter remover Tubing clamp 1500 ML suction canister with lid Bubble leak tester Stop watch or VACUTIMER Ohio Medical P N 6700 0438 800 Vacuum Calibration Gauge zero to full wall vacuum range 0 760 mmHg 0 101 3 kPa recommend Dwyer Series DPG 100 Digital Pressure Gauge or equivalent Dwyer Instruments Inc 219 879 8000 50 L min Flowmeter 6 50 L min scale recommend Dwyer VFA 26 or equivalent Dwyer Instruments 10 L min Flowmeter 1 10 L min scale recommend Dwyer VFB 66 or equivalent Dwyer Instruments 7 2 PTS ISU 7 2 1 Disassembly Assembly A WARNING If the vacuum regulator is repaired or disassembled in any manner the service checkout procedure must be performed before using the equipment on the patient WARNING To ensure service personnel are not exposed to hazardous contamination clean and disinfect all suction equipment before disassembly A CAUTION The Gauge Assembly must be handled with utmost care Do not rest the gauge on its face Note See SECTION 10 1 Illustrated Parts 1 Remove the four case screws from the back of the unit Holding the unit face up carefully pull the case and Knob Assembly
15. as follows a Carefully peel back and remove label from the knob b Disconnect the knob from the drive gear by grasping the knob to remove the knob screw c Rotate the faceplate collar counterclockwise to remove d Remove the face plate 8700 0001 000 Rev4 14 8 Set Up 2 Use a flathead screwdriver to rotate the flow control valve two turns counterclockwise from its seat Set 120 mmHg 16 kpa on the regulator gauge 4 Connect the regulator fitting port to the 10 LPM flowmeter 5 Turn the mode selector switch to IOIO INT 6 During the ON cycle adjust the intermittent flow rate to 8 LPM 1 LPM To increase the flow rate turn the valve counterclockwise To decrease the flow rate turn the valve clockwise Note If the regulator does not cycle OFF after 20 seconds use a flathead screwdriver and rotate the ON timing valve stem counterclockwise until the regulator cycles OFF 8 5 Timing Cycle Adjustment A WARNING If the screws on the timing valves are turned all the way clockwise the PTS ISU will not cycle Factory Settings ON Cycle 15 seconds 3 seconds OFF Cycle 8 seconds 3 seconds To set the timing cycles perform the following procedure 1 Occlude the fitting port or connect Vacutimer to fitting port 2 Turn the selector switch to CONT Set 120 mm Hg 16 kPa on the regulator gauge Turn the mode selector switch to O O INT with th
16. b is fully pushed in 5 8700 0001 000 Rev4 4 Operation 5 Cleaning Move the mode selector knob to IOIO Check that the intermittent timing cycles are approximately 15 seconds on and 8 seconds off by observing the gauge needle Note The PTS ISU starts in the ON cycle Push the suction control knob and reduce the suction to zero Set the mode selector to O OFF 4 5 Patient Setup Figure 8 1 Make sure the Pre Use Checkout Procedure has been performed Move the mode selector switch to CONT and push suction control knob 3 Set the prescribed suction level A CAUTION The suction control knob must be completely pushed in to adjust the vacuum level Failure to do so may damage the vacuum regulator Move the mode selector switch to O OFF Attach tubing from the vacuum regulator to the vacuum port of the collection container 5 1 Cleaning A WARNING After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy A WARNING Perform a service checkout procedure following cold flushing Validate the selected cleaning disinfection procedure Failure to do so may result in patient use of a product which is assumed to be clean disinfected and is not A CAUTION Unit failure due to cold flushing is not the respon
17. ble timing valves In use the vacuum source is connected through the regulator module which functions as an automatic valve Rotating the suction control knob adjusts the position of the regulator module and selects a predetermined level of suction Mode Selector Adapter Probe Switch Port Vacuum Gauge N Fitting Port wee Figure 2 Front and Side View 8700 0001 000 Rev4 2 3 Descriptions Specifications 3 1 Description Continued During use as the flow requirement increases the valve automatically opens to maintain suction at the preset level Conversely when the flow requirement decreases the valve automatically closes to maintain suction at the preset level The same mechanism compensates for changes in supply vacuum to automatically maintain the pre set suction level 3 2 Specifications Gauge Flow Rates Regulated Suction Range vacuum Pre Set Timing Cycles Weight Less Fittings Dimensions Less Fittings Environmental Specifications Operating Temperature Range Storage Temperature Range Operating and Storage Relative Humidity Accuracy Analog 5 of full scale deflection Accuracy Digital 1 of full range 22 C Continuous CONT Mode 0 80 LPM without fittings at full increase setting depending on supply vacuum and open air flow O O Intermittent INT Mode 8 LPM with the suction control knob set to 120 mm Hg 16 kPa 0 to 200 mm Hg 0 to 26 kPa and up to fu
18. ceeeeseteeeeeeeeeteeeeeeentaeeeeeeeaaes 13 7 5 Digital Gaugewiiccciee en ein 13 7 5 1 Removal of Batteries 13 7 5 2 Inserting Batteries 8 Service Checkout Procedure Oo SOU Dh aa 14 8 2 Push To Set TOSL wwwwwwwmmmamaaima amani 14 8 3 Leak Test Supply SIide lt w 14 8 4 FIOW Te St iia 14 8 4 1 Continuous Mode Flow Test 14 8 4 2 Intermittent Mode Flow Test 14 8 5 Timing Cycle Adjustment ccccceceeteeeeeees 15 8 6 Gauge lest AE den 15 8 7 Regulation TeSt wwwaamamanaanmwaananawananzama wanawa 16 8 8 Vacuum Buildup Bleed down Test Intermittent MOG E E A N Wa manzi wema mema 16 8 9 Bleed TeSt cccccccceceeceeeeeeeeeeeecaeceeeeteeeeeteeeeeens 16 8 10 Leak Test Patient Side 16 9 Maintenance 9 1 General Maintenance of Suction maf UTI SIA UA AAA etn sl de ai eee 17 9 2 Recommended Maintenance Schedule 17 9 2 1 Maintenance Schedule lt lt 17 9 3 Repa Polley AAA MA AWA AAA 18 9 4 Technical Assistance w w w w w wmmmmamasa 18 9 5 Return Instructions 18 9 6 Installation Procedure for Adapters Probes ANA FING aa 18 10 Ordering Information 10 1 Illustrated PAN nenen 19 20 8700 0001 000 Rev4 TOC 1 Definitions and Abbreviations 1 1 Definitions Note A note provides addition
19. e fitting port still occluded 5 Wait 20 seconds 6 If the regulator does not cycle OFF use a flat head screwdriver to rotate the ON timing valve stem counterclockwise until the regulator cycles OFF Wait 20 seconds 8 If the regulator does not cycle ON use a flat head screwdriver to rotate the OFF timing valve stem counterclockwise until the regulator cycles ON 9 Once the regulator has completed an ON and OFF cycle fine tune each cycle to the desired time by adjusting the corresponding valve To increase the time turn the timing valve stem clockwise To decrease the time turn the timing valve stem counterclockwise Use Ohio Medical VACUTIMER P N 6700 0438 800 to digitally measure timing cycles 10 Install the faceplate as follows a Install the faceplate with the top tab in the case notch b Install faceplate collar flat surface down and finger tighten clockwise c Place the knob on the drive gear protruding through and insert screw Hold the knob to tighten the screw d Replace the knob label OFF Valve Brass Flow Control Valve Figure 11 Setting Timing Cycles and Intermittent Flow Rate 8 6 Gauge Test Note All Ohio Medical Analog Gauges are supplied with an accuracy of 5 of full scale deflection throughout their range The PTS ISU vacuum gauges have an accuracy of 10 mmHg 1 3 kPa Note Digital gauges are supplied wit
20. ect 3 Ball Vac Kote is a registered trademark of the Ball Aerospace Systems Division Loctite is a registered trademark of Loctite Corporation 8700 0001 000 Rev4 18 10 Illustrated Parts 10 1 Illustrated Parts Diagram Description catalog service manual Part Number a 1 ANSI Analog Gauge Assy Standard 0 200 mmHg Digital Gauge Assy 0 200 mmHg N ISO Analog Gauge Assy Standard 0 200 mmHg ISO Analog Gauge Assy Standard 0 160 mmHg Gauge Mount Foam Actuator Push To Set Assy Cover Strip O RING 9 320D X 5 32ID X 1 16W Regulator Module Assy Foam Cap Plug Diaphram 0 o Piston w Stem 8700 0007 500 Spring 475 ID 8700 0011 400 o Spring 246 ID Housing O ring 018 NITRILE Quad ring 006 NITRILE Unilogic Module Assy with valves Filter Green Filter Beige Timing Valve Flow Control Valve Positive Pressure Relief Valve Vacuum Relief Plug Bleed Hole Filter Bleed Hole Orifice Detent Plate Mode Selector Switch Manifold Assy Manifold Screw PTS ISU Service Manual For information on ANSI and or ISO configurations fittings adapters and accessories refer to Ohio Medical s Suction and Oxygen Therapy Product and Accessory Catalog ms oO a 5 6 wo Item Ea k 9 36 a fed xe 19 8700 0001 000 Rev4 10 Illustrated Parts 20 6l oz j zz e l gt ez A r 94 J I l yA LL 6c OL vil He 0 ce YA Vv G Ge Ge 8 6
21. embly and Assembly 7 2 2 Assembly A CAUTION To prevent stripping the plastic case threads place the manifold screw in the hole and turn counterclockwise until it drops into the original threads Tighten screw 1 Before assembly lubricate all o rings and the rubber surface on the inside of the Mode Selector Switch with a small amount of Dow 111 2 Place the Gauge Bleed Hole Filter in its proper location 3 Install the Positive Pressure Relief Valve and the Vacuum Relief Plug Dow Corning 111 Valve Lubricant amp Sealant or equivalent 4 Unilogic Module Assembly a Install beige and green filters in the Unilogic Module b Install the seven o rings on the posts of the Unilogic Module c If removed during disassembly install Timing Valves and or Flow Control Valve Rotate each clockwise about 3 turns from thread engagement 5 Mode Selector Switch Assembly a Place the Mode Selector Switch into the Manifold Assembly rubberized side down b Install the Detent Plate on the Manifold Assembly detent fingers facing down c Install the Unilogic Module Push down until all posts and o rings are seated into Manifold Assembly Firmly tighten the two small screws 4 in lbs or 0 45 N m The Unilogic Module secures the Mode Selector Switch and seals it against leaks d After tightening the screws test Mode Selector Switch movement which should be firm Do not over tighten 6 Install the Regulato
22. four case screws v Install the Faceplate with the top tab in the case notch vi Install Faceplate Collar flat surface down and finger tighten clockwise Place the Knob on the Drive Gear protruding through Case and insert screw Hold the knob to tighten the screw vii viii Replace the Knob label Install adapters probes and fittings Note For proper installation of Adapters Probes and Fittings see section 9 8700 0001 000 Rev4 12 7 Service Disassembly and Assembly 7 3 Regulator Module Note See SECTION 10 1 Illustrated Parts A CAUTION Do not lubricate any internal components of the Regulator Module Assembly 7 3 1 Disassembly 1 Remove small quad ring from piston with stem and o ring from Housing Lubricate or replace if needed 2 Lift and pull tabs to pry off and remove Cap Peel Diaphragm from Piston with Stem Assembly With piston facing down lift threaded Housing to separate 5 Remove springs from stem 7 3 2 Assembly 1 Place folded Diaphragm on Piston with stem Make sure small number on Diaphragm is showing 2 With stem up install springs 3 Place threaded Housing on Piston with Stem Assembly Install quad ring on Piston with Stem Snap cap into place Ensure small tabs are fully seated against the Cap 6 Install o ring on threaded Housing 7 4 Timing and Flow Control Valves A CAUTION Do not over tighten the Timing Valve or Flow Control Valve stems Needle
23. h an accuracy of 1 of full range 220C Note All gauge needles should return to the stop pin when no suction is being supplied Gauges which do not comply may be out of calibration Note When checking gauge accuracy be sure that the calibration gauge has an accuracy of 1 full scale deflection or better 15 8700 0001 000 Rev4 8 Set Up 1 Connect the regulator fitting port to the vacuum calibration gauge with tubing Turn the mode selector switch to CONT Assure the regulator gauge is in agreement with the vacuum calibration gauge within the 10 mmHg 1 3 kPa tolerance Recommended test points are PTS ISU 40 80 140 and 200 mmHg 5 10 18 and 26 kPa 4 Push and rotate the suction control knob fully clockwise increase and verify the gauge reading is in the FULL VAC range vacuum calibration gauge should read 450 mmHg 59 8 kpa or higher 5 Turn the mode selector switch to IOIO INT 6 Verify the gauge reading is in the FULL VAC range vacuum calibration gauge should read 400 mmHg 50 kPa or higher 7 Turn the mode selector switch to CONT 8 Push and rotate the suction control knob fully counterclockwise decrease and verify the gauge reading decreases to zero 8 7 Regulation Test 1 Disconnect the vacuum calibration gauge from the regulator fitting port 2 Push and rotate the knob to set 90 mmHg 12 kPa 3 Without rotating release and push the knob several times
24. ient Side 8700 0001 000 Rev4 16 9 General Maintenance of Suction Equipment 9 1 General Maintenance of Suction 2 Wipe all exterior surfaces with a solution of Equipment water and mild detergent or approved cleaning solutions A WARNING The Pre Use Checkout Procedure 3 Perform a careful visual inspection must be performed before using this equipment on each patient If the regulator fails any part of the Pre Use Checkout Check that the high flow disposable suction filter is clean and in good condition Procedure it must be removed from service 5 Check that all tubing is in good condition and and repaired by qualified service personnel connected securely to the correct ports Wi 6 Check the floats in the Overflow Protection Device A WARNING Clean and disinfect all and collection canister for correct operation suction eguipment if contaminated before disassembly to ensure service personnel are not exposed to hazardous contamination 9 2 Recommended Maintenance Schedule 7 Perform the Pre Use Checkout Procedure PTS ISU should be kept in use or used on a rotating basis Internal parts of unused equipment may tend Ohio Medical vacuum regulators function for decades to deteriorate They are proven to provide trouble free service with l ae minimum care Maintenance of the vacuum piping system is as important as maintenance of the suction equipment The use of collection canisters with reliable shut off valves
25. ions Replace lubricate and repair as needed 17 8700 0001 000 Rev4 9 General Maintenance of Suction Equipment 9 3 Repair Policy A WARNING Clean and disinfect all suction equipment before shipment to ensure transportation personnel and or service personnel are not exposed to any hazardous contamination A CAUTION Do not steam autoclave or liquid sterilize the PTS ISU Severe impairment to the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide A CAUTION Only competent individuals trained in the repair of this equipment should attempt service Do not use malfunctioning equipment Make all necessary repairs Have the equipment repaired by qualified service personnel or by Ohio Medical After repair perform the Service Checkout Procedure to ensure that the product is functioning properly and complies with the manufacturer s published specifications 9 4 Technical Assistance If technical assistance is required contact Ohio Medical technical support at 1 857 855 0800 or toll free at 866 549 6446 9 5 Return Instructions 1 Clean and sterilize the vacuum regulator 2 Package securely for protection preferably in the original container 3 Include a letter describing in detail any difficulties experienced with the product Include the person title and telephone number to contact for functional questions 4 Call toll free 866 549 6446 o
26. ked 1 Turn valve counter clockwise until unit the CONT mode but or turned fully in cycles and or inspect valve seat area the INT mode will not 2 Timing valves turned fully in 2 Turn valve counterclockwise until unit cycle and or clogged cycles and or inspect valve seat area Note The regulator will 3 Unilogic Module malfunction 3 Replace filters and or module always start in the ON 4 Failed selector switch seal 4 See remedy J2 in this section of the mode Be sure that you manual Wail ab ieas 20 Seconds 5 Blocked manifold 5 Inspect manifold flow paths with the regulator port occluded to determine if 6 Missing damaged or 6 Replace or install o rings regulator is functioning incorrectly installed o rings 7 Degraded or clogged 7 Remedy Unilogic Module filters i Replace filters ii Replace Unilogic Module M Longer than expected 1 Clogged beige filter on the 1 Replace filter O OFF cycle time Unilogic Module 2 Gauge mount foam 2 Align misaligned N Gauge not aligned 1 Gauge mount foam missing 1 Replace or align torn or misaligned O Longer than expected 1 Blocked or clogged gauge 1 Unblock or unclog gauge bleed gauge bleed down bleed 2 Replace filter time 8700 0001 000 Rev4 10 7 Service Disassembly and Assembly 7 1 Service Tools and Equipment A CAUTION Use of lubricants other than recommended may degrade plastic or rubber components The following items should be on hand during
27. ld not be repaired other than in accordance with written instructions provided by Ohio Medical or by Ohio Medical trained personnel The Product must not be altered without the prior written approval of Ohio Medical s Quality Assurance Department The user of this Product shall have the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration by anyone This alpha character indicates the year of product manufacture and when the serial number was assigned L 2007 M 2008 N 2009 etc I and O are not used Technical Competence other than Ohio Medical The procedures described in this service manual should be performed by trained and authorized personnel only Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature No repairs should ever be undertaken or attempted by anyone not having such qualifications Genuine replacement parts manufactured or sold by Ohio Medical must be used for all repairs Read completely through each step in every procedure before starting the procedure any exceptions may result in a failure to properly and safely complete the attempted procedure 8700 0001 000 Rev4 Table of Contents 1 Definitions and Abbreviations 1 1 DetiNIWONS cecina 1 T2 Abbreviation S asan 1 2 Scope 2 1 ANSI Vacuum Regulator
28. ll wall On time cycle 15 seconds 3 seconds Off time cycle 8 seconds 3 seconds 20 oz 567 grams Height 6 5 inches 16 5 cm Width 2 8 inches 7 1 cm Depth 4 8 inches 12 2 cm 50 F 10 C to 104 F 40 C 13 F 25 C to 158 F 70 C 5 to 95 RH Non condensing 8700 0001 000 Rev4 4 Operation 4 1 Equipment Setup Locking Gland Fitting Insert the adapter probe into the vacuum wall outlet Figure 3 If the regulator is mounted elsewhere connect a vacuum supply hose between the regulator s adapter 1 Raise the sleeve and insert the OST into the probe and the wall outlet regulator fitting Turn the trap clockwise about one and a half turns A WARNING Connection to pressure sources to engage the threads The trap does not need to even momentarily could injure the patient or be screwed tight an O ring in the regulator fitting operator and damage the equipment provides a vacuum seal The trap should rotate freely to allow the desired nipple positioning Use hospital supplied suction tubing between the Lower sleeve to lock trap in position vacuum regulator and the collection container and between the patient port of the collection container and the patient minimum inside diameter is 6 O Regulator mm 0 25 in An Ohio Medical Hydrophobic Filter or Hydrophilic Sleeve Filter and Overflow Safety Trap OST should be used between the collection container and regulator to OST prevent contamination of the regula
29. ow path ii Replace Push To Set assembly 4 Knob fails to return when 4 See remedy D1 in this section of the pushed manual 5 Vacuum relief plug leaks or is 5 Replace or install correctly missing Positive pressure relief valve 6 Replace or install correctly leaks or is missing H Inaccurate gauge Damaged gauge Replace gauge reading Note The gauge needle analog gauge should return to the stop pin when no suction is being supplied With the knob pushed 1 Blocked bleed filter and or 1 Clear orifice and replace filter in unable to decrease orifice the suction level and 2 Damaged gauge 2 Replace gauge AA 3 Cross threaded regulator 3 Install correctly to O OFF module 4 Regulator module 4 See Regulator module malfunction under malfunction the Problem column in this section of the manual Limited suction in any 1 Selector switch not fully in 1 Move fully to desired position setting and whistling CONT or INT position noise from inside the 2 Failed selector switch seal 2 Remedy regulator ee 9 a Ensure Unilogic Module screws are b adeguately tightened Replace selector switch 9 8700 0001 000 Rev4 6 Troubleshooting K Whistling ouzzing 1 Cap foam plug missing or 1 Replace noise from inside the deteriorated shrunk regulator 2 Cap foam plug pushed too 2 Replace or install just flush with underside far into cap of cap Suction is deliveredin 1 Flow control valve is bloc
30. r 1 847 855 0800 and ask customer service for an RMA number to include with your shipment 5 Ship the Vacuum Regulator prepaid Write your return address and billing address information on the package or letter that comes with the package Ship To Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 4099 USA 1 847 855 0800 9 6 Installation Procedure for Adapters Probes and Fittings A CAUTION Do not use any Loctite products to seal the threads or product which contain Methacrylate Ester as an active ingredient All adapters probes and fittings should be installed properly to prevent leaks and to support the equipment when mounted Both vacuum regulator ports are 1 8 27 NPT tapered pipe threads It is important to note that adapters probes and fittings seal on the thread and may have threads exposed after they have been tightened properly Prior to installing the adapter probe or fitting wrap the thread with PTFE tape or apply Dow 111 Ball Vac Kote 37951M or equivalent The torque range for installing adapters probes and fittings is 4 0 ft lb 5 4 N m minimum to 10 0 ft lb 13 6 N m maximum Adapters probes and fittings which are not keyed for specific orientation should be torqued to approximately 6 0 ft lb 8 1 N m Adapters probes and fittings that are keyed to specific orientation must be torqued initially to 4 0 ft lbs 5 4 N m Additional torque is applied only until orientation is corr
31. r Module Assembly by turning counterclockwise left handed threads Rotate the stud so the flats are vertical Install Push To SetTM Assembly 8 Position Actuator on Unilogic Module over Regulator Module Assembly and resting on Push To SetTM Assembly 9 Gauge assembly a Attach small o ring to the gauge post on the Unilogic Module Assembly b Also insert one o ring into the gauge orifice Ensure o ring is flush c Attach the foam to the back of the gauge with the short leg at six o clock Connect the Gauge Assembly to the gauge post on the Unilogic Module Assembly Ensure the Gauge Assembly is properly aligned 10 Installing Case a With Faceplate and Knob Installed i With the flats on the outside of the drive gear horizontal pull the Knob to lock in position ii Holding manifold assembly face up place and align the Case and Knob Assembly onto the Manifold Assembly with the Mode Selector Switch in the O OFF position iii Carefully center the slot in the Cover Strip to fit around the Mode Selector Switch tab iv Install the four case screws b Without Faceplate and Knob Installed i Install Drive Gear on Regulator Module Assembly stem ii Holding Manifold Assembly face up place and align the Case onto the Manifold Assembly with the Mode Selector Switch in the O OFF position iii Carefully center the slot in the Cover Strip to fit around the Mode Selector Switch tab iv Install the
32. rol knob when cycled ON f ra OFF 1016 WA A CAUTION The suction control knob must be completely depressed in order to adjust the vacuum level Failure to do so may damage the vacuum regulator 4 4 Pre Use Checkout Procedure A WARNING The Pre Use Checkout Procedure must be performed before using the equipment on each patient If the regulator fails any part of the Pre Use Checkout CONT Suction is continuous and can be Procedure it must be removed from service adjusted with the suction control knob and repaired by qualified service personnel All tests must be performed with supply vacuum of 500 mmHg 67 kPa minimum 1 Turn the mode selector switch to O OFF Push and rotate the suction control knob one full turn clockwise increase Release The gauge needle should not move 2 Move the mode selector switch to CONT The gauge should indicate vacuum Push and rotate the suction control knob fully counter clockwise decrease until it stops and release The gauge 4 3 Setting the Suction Level Mi needle should move to zero and remain there 1 Turn the mode selector switch to CONT 3 Push the suction control knob and set the following REGULATOR Type SETTING PTS ISU Increase the suction to 90 mmHg 12 kPa 4 Slowly release and push the suction control knob to create various flow rates through the regulator Check that the suction level is maintained when the kno
33. sibility of Ohio Medical and may invalidate the warranty Failure to adequately dry the product following a cold flush may damage the working parts which are designed for pneumatic air flow only Failure to disassemble to check O ring and filter status may render the unit inoperative A CAUTION Suctioned fluids drawn into a vacuum regulator do not stop in the regulator They proceed through it into the wall outlet and pipeline system Failure to clean and disinfect the wall outlet and pipeline system may result in damage to this equipment 5 1 1 Routine Exterior Cleaning Routine cleaning of the regulator is recommended as a standard procedure after each use Wipe all exterior surfaces with a solution of water and mild detergent 5 1 1 1 Approved Cleaning Solutions e Virex Quaternary Ammonium 0 2 Mixture of 1 fl oz of Virex to 1 gallon 128 fl oz tap water using Virex 128 e Kleenaseptic Full strength from spray can e Bleach Sodium Hypochlorite 0 5 Mixture of 13 fl oz of Clorox household bleach to 1 gallon 128 fl oz tap water e Betco TB Plus Mixture of 1 fl oz to 1 gallon 128 fl oz tap water e Glutaraldehyde e Isopropyl Alcohol 70 e Hydrogen Peroxide 3 e Cavicide Ready to use full strength 8700 0001 000 Rev4 6 5 Cleaning 5 1 2 Internal Component Cleaning A CAUTION Cleaning the gauge may result in damage 1 Refer to the Service Disassembly and Assembly instruc
34. tions Section 7 2 All internal components with the exception of the gauge may be cleaned with a solution of warm water and mild detergent 3 Dry all components with a lint free cloth before assembly Dry internal passages using vacuum flow or compressed air 4 Perform Service Checkout Procedure Section 8 5 1 2 1 Approved Flush Solutions Warm water and mild detergent 5 1 3 Cold Flush Procedure If desired the vacuum regulator can be cold flushed as part of a cleaning or disinfecting procedure Set up a collection canister or liner between the vacuum source and the adapter probe port of the vacuum regulator to receive the flush solution Suction through the vacuum regulator an adequate amount of cold disinfectant to satisfy the infection control requirements of the hospital Use only approved cleaning flushing solutions Make sure those made from concentrates are newly mixed to ensure effectiveness Flush both the continuous and intermittent vacuum circuits thoroughly Adequately aerate both the 5 2 Disinfection Should misuse occur resulting in accidental flooding of the regulator the regulator may be disinfected using Ethylene Oxide ETO After disinfection follow the service checkout procedures in Section 8 A WARNING Following disinfection with ethylene oxide parts should be quarantined in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material Follow ETO processor
35. tor wall outlet and pipeline system ISO 10079 3 BS 7259 Part 2 section 5 1 2 states that the usable volume of the collection container shall not be less than 500 ml Suction Filters DISS fitting Hydrophilic Nipple Figure 4 20 Pack 6730 0350 800 200 Pack 6730 0351 8000 Insert the OST into the regulator fitting Situate the nipple in the desired position Hydrophobic Turn the DISS wing nut clockwise to engage Nipple Threaded threads and tighten there is no O ring so the 3 Pack 6700 0570 800 6700 0580 800 vacuum seal depends on a tight connection 10 Pack 6700 0571 800 6700 0581 800 50 Pack 6700 0572 800 6700 0582 800 Regulator Note For proper installation of adapters probe and fittings see section 9 4 1 1 Attaching the Overflow Safety Trap Ost OST s Wing nut i oh Ali eats A CAUTION To help prevent aspirate from entering the regulator as a result of misuse an OST should be attached prior to its use Aspirate in the regulator may impair its operation The use of the OST and suction filter will help prevent this and extend the life of suction equipment 8700 0001 000 Rev4 4 4 Operation 4 2 Mode Selection Figure 7 2 Push and rotate the suction control knob until the vacuum gauge indicates the required setting Figure 5 IOIO INT suction is intermittent cycled on and off and the suction level can be adjusted with the suction cont
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