8700-0006-000 CVR Service Manual R3.indd - BOC e
Contents
1. f NN 2 Turn the mode selector switch to On and use PTS 6 Turn the mode selector switch to On Important The 3 Set the prescribed suction level Low models do not deliver suction in excess of 150 mm Hg 20 kPa A CAUTION The PTS must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction k 8700 0006 000 Rev 3 8 5 Cleaning amp Sterilization 5 1 Cleaning A WARNING After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy 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 2 Internal Component Cleaning CAUTION Cleaning the gauge may result in damage The regulator requires cleaning if it becomes flooded with patient fluid as a result of misuse 1 Refer to the Service Disassembly and Assembly instructions 2 Allinternal components with the exception of the gauge may be cleaned with a solution o2. 4 Regulator Setting Standard amp Low increase the suction to 100 mm Hg 13 kPa High increase the suction to 300 mm Hg 40 kPa Slowly open and close the clamped tubing to create various flow rates through the regulator Check that the suction level is maintained when the tubing is clamped For Standard 2 Mode Continuous go to step 5 4a High and Standard 3 Mode Continuous Turn the mode selector to MAX Clamp tubing and check that the gauge needle indicates the maximum available suction Turn the mode selector to I On 4b Low Continuous Clamp tubing and rotate knob fully clockwise increase to verify the suction level does not exceed 150 mm Hg 20 kPa Pre Use Checkout A WARNING Test performed at gt 500 mmHg 67 kPa 1 Reduce the suction level to zero and set the mode selector switch to O Off 8700 0006 000 Rev 3 4 Operation 4 6 Patient Setup 4 Turn the mode selector switch to O Off 5 Attach tubing to the vacuum port of the collection 1 Make sure the Pre Use Checkout Procedure has been container performed
3. adapter port threads or products which contain Methacrylate Ester as an active ingredient Only competent individuals trained in the repair of this equipment should attempt to service it To help prevent aspirate from entering the regulator as a result of misuse an Overflow Safety Trap and suction filter should be attached prior to its use Aspirate in the regulator will impair the operation The use of the Overflow Safety Trap and suction filter will help prevent this and extend the life of the suction equipment Use of lubricants other than recommended may degrade plastic or rubber components Prior to placing the unit back into service after repair or disassembly perform the Service Check out Procedure Not for Field or Transport use Loctite is a registered trademark of the Loctite Corp The categories of Field and Transport Use are specifically defined in ISO 10079 3 Field means use at accidents or emergencies outside a hospital Transport means use in ambulances cards and airplanes These situations may expose the equipment to uneven support water dirt mechanical shock and temperature extremes Ohio Medical suction equipment has not been tested to comply with the specific requirements of these categories 8700 0006 000 Rev 3 2 Scope This service manual contains service maintenance and parts information on all models of the Push To Set Continuous Vacuum Regulator North American Inter
4. WARNING When servicing a Low Vacuum Regulator perform the Vacuum Relief Valve Adjustment and Low Vacuum Limit Setting Procedure CAUTION The gauge assembly must be handled with utmost care to retain its precision If the lens is removed do not rest the gauge on its face 13 Note See Section 10 1 Illustrated Parts 1 Remove the four cover screws from the back of the regulator 2 Carefully pull the cover assembly off the back body 3 To remove the gauge assembly grasp the assembly and pull straight out The snap fit lens can also be removed if applicable for replacement 4 Remove actuator and PTS assembly 5 Toremove the regulator module from the cover assembly rotate the suction control knob counterclockwise until the regulator module is free 6 Using tweezers remove the filter Replace with a new filter 7 Grasp the positive pressure safety relief valve and pull it from the back body 8 Remove the mounting screw from the switch plate assembly and remove the switch plate and mode switch 9 Low models ONLY Grasp the vacuum relief valve and pull it from the back body 7 2 2 Assembly CAUTION To prevent stripping the plastic threads place the screw in the hole and turn counterclockwise until it drops into the original thread Tighten screw 1 Place the positive pressure safety relief valve in position and push onto the back body 2 Low models ONLY Lubricate the vacuum relief valve O ring and i
5. information on the package or letter that comes with the package For all Repairs Contact your nearest Ohio Medical office or authorized Ohio Medical Distributor 18 9 Maintenance 9 6 Warranty This Product is sold by Ohio Medical under the warranties set forth in the following paragraphs Such warranties are extended only with respect to the purchase of this Product directly from Ohio Medical or Ohio Medical s Authorized Dealers as new merchandise and are extended to the first Buyer thereof other than for purpose of resale For a period of One hundred and twenty 120 months from the date of original delivery to Buyer or to Buyer s order but in no event for a period of more than two years from the date of original delivery by Ohio Medical to an Ohio Medical Authorized Dealer this Product other than its expendable parts is warranted to be free from functional defects in materials and workmanship and to conform to the description of the Product contained in this operation manual and accompanying labels and or inserts provided that the same is properly operated under conditions of normal use that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided This same warranty is made for a period of thirty 30 days with respect to the expendable parts The foregoing warranties shall not apply if the Product has been repaired other than by Ohio Medi
6. its use Aspirate in the regulator wall outlet and pipeline system may impair their operation The use of the Overflow Safety Trap and suction filter will help prevent this and extend the life of suction equipment Locking Gland Fitting 1 2 3 Raise the sleeve and insert the trap into the regulator fitting Turn the trap clockwise about one and a half turns to engage the threads The trap does not need to be screwed tight an O ring in the regulator fitting provides a vacuum seal The trap should rotate freely to allow the desired tubing positioning Lower sleeve to lock trap in position Regulator DISS fitting 1 2 Insert trap into the regulator fitting Situate the tubing in the desired position Turn the DISS wing nut clockwise to engage threads and tighten there is no O ring so the vacuum seal depends on a tight connection Regulator Wing Nut 8700 0006 000 Rev 3 4 Operation 4 3 Mode Selection 4 4 Setting the Suction Level On Suction can be adjusted with the suction control 1 Turn the mode selector switch to knob On 2 Occlude or clamp tubing 3 Rotate the suction control knob until the vacuum gauge indicates the required setting 3 Mode Switch O Off No suction is supplied to the patient A 2 Mode Switch A KE 3 Mode Switch MAX Maximum full line vacuum is supplied to the patient All tests must be performed
7. located inside the cover behind the suction control knob The vacuum relief valve has also been changed to limit the vacuum to the same level as the set screws did This new vacuum relief valve has four vent holes the old valve had two If a new cover is used a new vacuum relief valve must be used Versions with limiting screws have two means of limiting the suction level 1 Low vacuum limiting screws in the cover these can be set at 140 mmHg 19 kPa 10 mmHg 1 0 kPa 2 Vacuum relief valve this can be set at 165 mmHg 15 mmHg 22 kPa 2 kPa These vacuum limit settings may be reduced to accommodate user requirements If the vacuum limit settings are reduced the vacuum relief valve must be set 25 mmHg 15 mmHg 3 kPa 2 kPa higher than the vacuum limiting screws Versions without the limiting screws use only the relief valve to limit the suction level The relief valve can be set at 140 mmHg 5 mmHg 18 7 kPa 0 7 kPa 7 3 1 Low Vacuum Limiting Screws CAUTION When adjusting the vacuum limiting screws be sure to adjust them to an equal height CAUTION Remove the Increase label carefully Press firmly in place when replacing 1 Remove the Increase label and place it aside Be careful not to damage the face or glued back of the label 2 Adjust the two vacuum limiting screws located behind the suction control knob until they are the same height in the case Use a 3 32 hexagonal allen wrench 3 Con
8. positive side facing up relative to the display Supply Vacuum 500 mmHg 67 kPa Minimum and Supply Vacuum Reg set Open Flow of to 500 mmHg 10 mmHg 50 LPM Minimum 64 kPa 1 3 kPa 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 AN WARNING If the Vacuum Regulator is repaired Occluded or disassembled in any manner the Service f High Vacuum Low Vacuum Checkout Procedure must be performed before Fiowmeter Calibration Gauge Calibration Gauge using the equipment ona patient 50 LPM 760 mmHg 101 3 kPa 225 mmHg 30 kPa Important This entire Service Checkout Procedure 8 2 Push To Set Test must be performed in numerical order 1 Connect the 10 LPM Flowmeter to the patient port 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 Replace the knob It should fully return 8 3 Gauge Test Note All Ohio Medical gauges are supplied with an accuracy of 5 of full scale deflection throughout their range The ta
9. valve Turning the suction control knob adjusts the position of the regulator module and allows selection of a predetermined level of suction when set according to instructions 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 and automatically maintains the pre set suction level when set according to instructions 1 Suction Control Knob Allows easy adjustment of suction to the patient 2 Mode Selector Switch Allows quick and easy mode changes a On Suction can be adjusted with the suction control knob b O Off No suction is supplied to the patient c MAX Maximum full line vacuum is supplied to the patient 3 Vacuum Gauge The suction level to the patient is displayed during use Adapter Port Fitting Port 8700 0006 000 Rev 3 3 2 Specifications Gauge Flow Rate Positive Pressure Safety Relief Valve Ranges Standard Models High Models Low Models 3 Specifications 5 of full scale deflection 1 of full range at 22 C Accuracy Analog Accuracy Digital 0 to 80 LPM without fittings at full increase setting depending on supply vacuum and open air flow Located in the vacuum supply line to prevent pressurization of the pa
10. with supply vacuum of 380 mm Hg 51 kPa minimum 1 Turn the mode selector switch to O Off Rotate the suction control knob one full turn clockwise increase Clamp tubing to occlude the fitting port The gauge needle should not WARNING The regulator fitting port or patient connector must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction h 4 5 Pre Use Checkout Procedure WARNINGS 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 Procedure it must be removed from service and repaired by qualified service personnel WARNINGS Connect the vacuum regulator to the vacuum source only and check it s operation before attaching the patient connection Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment move 2 Turn the mode selector switch to On Rotate the A suction control knob es po Note available on three mode vacuum regulators only fully anti clockwise decrease sb Clamp tubing The gauge needle should not move 8700 0006 000 Rev 3 4 Operation 3 Clamp tubing
11. x 133 kPa 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 oz Ounces DISS Diameter Index Safety System OES Oxequip Suction NCG National Compressed Gases Chemetron NPT National Pipe Thread USA NPTF National Pipe Thread Female USA MPTS Multi Purpose Therapy Stand gal Gallon PTFE Teflon PTS Push To Set 8700 0006 000 Rev 3 1 Precautions 1 2 Warnings After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy Clean and sterilize all suction equipment before shipment or service to ensure transportation personnel and or service personnel are not exposed to any hazardous contamination Connectthe Vacuum Regulator to the vacuum source only and check its operation before attaching the patient connection Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment 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 If the Vacuum regulator is repaired or disassembled in any manner the Service Checkout Procedure must be performed before using the equipment on a patient 1 3 Cautions Do not lubricate any internal components of the regulator module Do not use any Loctite products to seal the fitting and
12. 0MM 0 160 mmHg 8700 0024 400 0 650 mmHg VR DGP 760MM Replacement Battery VR DGP BAT 8700 0006 000 Rev 3 20 1111 Lakeside Drive Gurnee IL 60031 4099 USA Tollfree 866 549 6446 Phone 847 855 0800 oO Fax 847 655 6218 www ohiomedical com Medical Corporation always there for life North America United States Customer Service and Distribution Center Technical Suopport Sales and Services Equipment Service Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 4099 USA Tollfree 866 549 6446 Phone 847 855 0800 Fax 847 655 6218 www ohiomedical com 8700 0006 000 Rev 3 01 2009
13. W Ohio _ Push To Set Continuous Vacuum Regulators PTS CVR Service Manual 3 Mode 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 Product Date Coding AAA A 12345 Technical Competence The procedures described in this service manual should be performed 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 any one not having such qualifications Genuine replacement parts manufactured or sold by Ohio Medical must be used for all repairs and repaired 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 necessa
14. ator prior to disassembly shipment or use Aerate parts prior to reassembly Freon is a registered trademark of the DuPont Company 8700 0006 000 Rev 3 10 6 Troubleshooting Problem Possible Causes Remedy A No gauge indication and no suction in any setting No supply vacuum Kinked tube Poor connection Blocked wall outlet Blocked adapter probe port Blocked backplate Blocked adapter Correct supply problems Straighten tube Check all connections and seals Unblock outlet Unblock port Clean with soap and water and a pipe cleaner See regulator module malfunction under the Problem column in this section of the manual Regulator module malfunction O ring quad ring or diaphragm failure Cap not completely snapped to housing Springs are not installed correctly Pinched diaphragm Replace rubber components Fully snap cap onto housing Ensure that springs are properly installed Reinstall or replace diaphragm No gauge indication but suction is being delivered Gauge indication but no suction is being delivered Blocked gauge pressure sensing orifice Blocked gauge pathway through Unilogic Module Failed gauge o ring seal Gauge mechanism is damaged Dead Batteries Knob fails to return when pushed Blocked fitting port Overflow Protection Device Shut off Blocked external suction filter Blocked fitting Leak in system Unblock orifice Clear pathway Reinstall or rep
15. auses many plastic parts to deteriorate 13 14 Lock the adjusting screw with a drop of removable thread locker such as Loctite 242 Repeat step 5 to verify the vacuum relief valve setting Loctite is a registered trademark of the Loctite Corporation 7 4 Regulator Module A WARNING If repairing or replacing a regulator module on a Low Vacuum Regulator you must perform the Suction Level Limit Setting Low Models ONLY Procedure Failure to do this may result in suction exceeding the prescribed level A CAUTION Do not lubricate any internal components of the regulator module CAUTION The cap screws can strip the regulator module housing threads if they are screwed in too tight 7 4 1 Disassembly 1 Remove timing and flow control valves by turning counterclockwise with a flat head screwdriver 2 Replace and or lubricate o rings as needed 14 7 Service Disassembly Assembly 8 Service Checkout Procedure 7 4 2 Assembly 8 1 Set up 1 Carefully insert and tighten the timing valves 1 Verify that there is 500 mmHg 10 mmHg 67 kPa 1 3 Press flow control valve in to engage o ring then tighten kPa vacuum on the supply gauge 3 Rotate each clockwise about 3 turns form thread 2 The supply open flow must be 50 LPM minimum engagement 3 Connect the supply vacuum to the adapter port 7 5 Digital Gauge HSS 9 9 ana Supply Vacuum Gauge Ai r 0 760 mmHg 0 101 3 kPa Note Both batteries are positioned with the
16. ble below is provided for reference Note Digital Gauges are supplied with an accuracy of 1 of full range at 22 C Note All gauge needles should come to rest within the zero range bracket or return to the stop pin when no suction is being supplied Gauges which do not comply may be out of calibration When checking gauge accuracy be sure that the calibration gauge has an accuracy of 1 of full scale deflection or better 15 8700 0006 000 Rev 3 8 3 1 High Vacuum Gauges ONLY 1 2 3 Connect the regulator s fitting port to the high calibration gauge with tubing Turn the mode selector switch to On Assure that the gauge is in agreement with the high vacuum calibration gauge within the 38 mmHg 5 kPa tolerance Recommended test points are 100 300 and 500mm Hg 8 3 2 Standard and Low Vacuum Gauges ONLY 1 2 3 Connect the regulator s fitting port to the low calibration gauge with tubing Turn the mode selector switch to On Assure that the gauge is in agreement with the low vacuum calibration gauge within the 10 mmHg 1 3 kPa or the 8 mmHg 1 1 kPa tolerance for standard and low gauges respectively Recommended test points are 40 80 and 140 mmHg For the Standard Gauge ONLY Rotate the suction control knob fully clockwise increase and verify its reading is in the FULL VAC range 8 4 Regulation Test 1 2 Disconnect the calibration gauge and occlude the fitting port If usin
17. cal or in accordance with written instructions provided by Ohio Medical or altered by anyone other than Ohio Medical or if the Product has been subject to abuse misuse negligence or accident Ohio Medical s sole and exclusive obligation and Buyer s sole and exclusive remedy under the above warranties is limited to repairing or replacing free of charge at Ohio Medical s option a Product which is telephonically reported to the nearest Ohio Medical Regional Service Office and which if so advised by Ohio Medical is thereafter returned with a statement of the observed deficiency not later than seven 7 days after the expiration date of the applicable warranty to the designated Ohio Medical Service Office during normal business hours transportation charges prepaid and which upon Ohio Medical s examination is found not to conform with the above warranties Ohio Medical shall not be otherwise liable for any damages including but not limited to incidental damages consequential damages or special damages There are no express or implied warranties which extend beyond the warranties hereinabove set forth Ohio Medical makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof 19 9 7 Installation Procedure for Adapters Probes and Fittings CAUTION Do not use any Loctite products to seal the threads or product which contain Methacrylate Ester as an active
18. e Vacuum Cover Strip Switch Actuator Occlude To Set O Ring 2 013 Nitrile OTS Assembly Support Bracket Actuator Assembly Reg Mod O Ring 9 32 OD x 5 32 IS x 1 16 W Plate Detent Item 16 10 Ordering Information 8700 0016 500 See table below See table below See table below 6700 0115 400 0206 5159 300 6700 0121 400 8700 0009 700 6700 0151 400 8700 0016 100 8700 0005 100 8700 0056 500 See table below Part Number Description Selector Switch Overmolded Plug Pull Tab Vacuum Relief Assembly O Ring 2 014 Nitrile Buna N Relief Valve Positive Pressure Plug Filter Orifice Continuous Vacuum Regulator Manifold Assembly Screw Self Tap 6 Pan Head Serial Number Label Knob Label Plug Label ee ae ee M E a ee ae en eG Model Item 3 Item 17 Item 18 O Ring 2 014 Item 27 Case Regulator Vacuum Relief Assembly Nitrille Buna N Label Plug Pull Tab 8700 0012 500 8700 0022 500 8700 0012 500 8700 0022 500 8700 0053 500 8700 0053 500 8700 0022 500 8700 0039 500 8700 0039 500 8700 0039 500 N A N A N A 8700 0039 500 N A N A N A 6700 0045 700 6700 0045 700 6700 0045 700 N A N A N A N A 6700 0135 500 6700 0135 500 6700 0135 500 N A N A N A N A 8700 0036 101 8700 0036 102 N A N A Item 6 Item 6 Vacuum Gauge Analog Vacuum Gauge Digital Range P N Range P N 0 200 mmHg 8700 0002 400 0 160 mmHg VR DGP 160MM 0 760 mmHg 8700 0022 400 0 200 mmHg VR DGP 20
19. e Push To Set assembly 4 Knob fails to return when See remedy D1 in this section of the pushed manual 5 Vacuum relief plug leaks or is Replace or install correctly missing 6 Positive pressure relief valve Replace or install correctly leaks or is missing H Inaccurate gauge reading 1 Damaged gauge Replace gauge Note The gauge needle should return to the stop pin when no suction is being supplied With the knob pushed in 1 Blocked bleed filter and or Clear orifice and replace filter unable to decrease the orifice suction level and gauge needle does not return to zero when switched to O 2 Damaged gauge Replace gauge 3 Cross threaded regulator Install correctly OFF module See Regulator module malfunction 4 Regulator module malfunction under the Problem column in this sec tion of the manual Limited suction in any 1 Selector switch not fully in Move fully to desired position setting CONT or INT position 2 Failed selector switch seal Remedy a Ensure Unilogic Module screws are adequately tightened b Replace selector switch Whistling ouzzing noice 1 Cap foamplug missing or Replace from inside the regulator deteriorated shrunk 2 Cap foamplug pushed too far Replace or install just flush with into cap underside of cap L Gauge not aligned 1 Gauge assembled incorrectly 1 Re assemble unit per specification M Longer than expected 1 Blocked or clogged gauge 1 Unblock or unclog gaug
20. e bleed gauge bleed down time bleed 2 Replace filter 8700 0006 000 Rev 3 12 7 Service Disassembly 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 any service procedure Supply vacuum 500 mm Hg 10 mmHg 67 kPa 1 3 kPa amp 50 LPM open air flow minimum Supply Vacuum Regulator with Gauge 760 mm Hg 101 3 kPa Full Scale Low Vacuum Calibration Gauge 225 mm Hg 30 kPa Full Scale Ohio Medical P N 6700 0353 800 High Vacuum Calibration Gauge 760 mm Hg 101 3 kPa Full Scale Ohio Medical P N 6700 0352 800 80 LPM Flowmeter Phillips Head Screwdriver No 2 Flat Head Screwdriver 1 4 inch Tubing Clamp Bubble Leak Tester Tweezers Filter Remover Wooden Tooth Pick O ring Remover Pipe Cleaner Phillips head screwdriver No 1 Stop watch or vacutimer Ohio Medical P N 6700 0438 800 Open end adjustable wrench 10 LPM flowmeter Accuracy 1 of full scale deflection 7 2 Continuous Vacuum Regulators All Models 7 2 1 Disassembly A 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 a patient WARNING Clean and sterilize all suction equipment if contaminated before disassembly to ensure service personnel are not exposed to hazardous contamination
21. e quarantined in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material Follow ETO processor 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 before returning the regulator to service 4 Perform Service Checkout Procedure Section 8 5 2 Sterilization Should misuse occur resulting in accidental flooding of the regulator the regulator may be sterilized using Ethylene Oxide ETO After sterilization follow the service checkout procedures in Section 8 A WARNING Following sterilization with ethylene oxide parts should be quarantined in a well ventilated area to allow dis
22. ection nuiosa eae ubetieetentisiandes 6 4 4 Setting the Suction LeVel ppp 6 4 5 Pre Use Checkout Procedure ppp 6 4 6 Patient SetzlD ee 8 5 Cleaning and Sterilization S SIC AMIN dex scaz cts heaved aus Scevdern vadeeecaeectiy auaeeseeertingadeees 9 5 1 1 Routine Exterior Cleaning ppp 9 5 1 2 Internal Component Cleaning pp 9 5 1 3 Cold Flush Procedures RN 9 HAA DISINTSCUNG 9 5 2StehilZzatG 9 6 Troubleshooting ee 11 7 Service Disassembly and Assembly 7 1 Service Tools and Equipment pp 13 7 2 Continuous Vacuum Regulators All Models 13 L251 DISASSSMADIY rasne ee 13 Tee ASSOMBIY 23 cosccs sritedeen ads rvesdesseweeeartiedantsenar eens 13 7 3 Suction Level Limit Setting Low Models ONLY 14 7 3 1 Low Vacuum Limiting ScrewWwS pp 14 7 3 2 Vacuum Relief Valve Adjustment 0 ccee 14 7 4 Regulator Module pp 14 LACT DISASSEMADNY as 14 SeA 2 ASSOMDMY orea deve cccsenteedeclel RR 14 7D Digital gaug eens 15 7 5 1 Removal of batteries 15 7 5 2 Inserting Batteries essesi 15 Table of Contents 8 Service Checkout Procedure Ba SS OTHUP se sinerang eiar dees 16 B22 FOW es 16 8 3 GAUGE es 16 8 3 1 High Vacuum Gauges ONLY ppp 16 8 3 2 Standard and Low Vacuum Gauges ONLY a aisimi uuan isai eaa aE 16 8 4 Regulation est as 16 8 5 Low Vacuum Regulators ONLY pp 16 8 6 Bleed TeSt ee 16 8 7 Leak Test Supply Side pp 16 8 8 Leak Test Patient Side pp 16 9 Maintenance 9 1 General Maint
23. edical Parts listed in the service manual for this product may be repaired or replaced by a competent trained person who has experience in repairing devices of this nature After repair perform the Service Checkout Procedure to ensure that it is functioning properly and complies with the published specifications 9 4 Technical Assistance If technical assistance is required contact Ohio Medical technical support or field operations listed on the back cover 8700 0006 000 Rev 3 9 Maintenance 9 5 Return Instructions _ Call 866 549 6446 for a returned goods authorization 2 Clean and sterilize the Vacuum Regulator 3 Package the Vacuum Regulator securely for protection preferably in the original container 4 Include a letter describing in detail any difficulties experienced with the Vacuum Regulator Include the person title and telephone number to contact for functional questions 5 Ohio Medical now offers a ten year warranty on vacuum regulators sold on or after July 1 2005 If the vacuum regulator was purchased on or after July 1 2005 and is less than ten years old or if the vacuum regulator is covered under the previous warranty and is less than five years old include the warranty information that came with the device and a copy of the invoice 6 Include a purchase order to cover repair of a regulator not under warranty 7 Ship the Vacuum Regulator prepaid Write your return address and billing address
24. enance of Suction Equipmert 17 9 2 Recommended Maintenance Schedule 17 9 2 1 Maintenance Schedule pp 17 973 Repar POMC y eean 18 9 4Technical Assistance ppp 18 9 5 Return Instructions pp 18 DO NAN we 19 9 7 Installation Procedure for Adapters Probes AMG FUNG Sene 19 10 Ordering Information 10 1 Illustrated Parts sa 20 10 2 Service II 20 10 3 Fittings and Adapters pp 20 10 4 North AMENGAN stoeie iaaiaee diea aada 20 10 4 1 Regulator Options pp 20 10 4 2 Other Options sas rrpineo arsaigh inadina 20 10 5 International ssanie naag 20 10 5 1 Regulator OPtONS ssss iesi massaansa 20 10 5 2 Other Options scsisssociiroscisnna 20 1 Precautions Definitions Note ANote provides additional 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 equipment exists AN WARNING A WARNING statement is used when the possibility of injury to the patient or the operator exists MAX maximum High Flow High Vacuum high flow high vacuum High Flow Low Vacuum high flow low vacuum On on O Off off Abbreviations Used In This Manual CCW Counterclockwise Anti clockwise CVR Continuous Vacuum Regulator Full Line Vacuum in Hg Inches of mercury kPa Kilo pascals kPa x 7 50 mm Hg LPM Liters per minute mm Hg Millimeters of mercury mm Hg
25. f warm water and mild detergent 3 Dry all components with a lint free cloth before assembly Dry internal passages using vac flow or compressed air 5 1 3 Cold Flush Procedure A CAUTION Do not cold flush digital unit 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 continuous and intermittent circuits with vacuum flow or compressed air until all internal channels switches gauge ports and regulating mechanisms are dry Disassemble to check O rings for adequate lubricant and filters for proper function following any cold flush procedure Perform Service Checkout Procedure Section 8 5 1 4 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 AN WARNING Following disinfection with ethylene oxide parts should b
26. g a High Vacuum Regulator set its gauge to 300 mmHg 40 kPa If using a Low or Standard Vacuum Regulator set its gauge to 100 mmHg 14 kPa Open and close the fitting port several times With the fitting port occluded the gauge should return to the setting listed in step 2 within a tolerance of 38 mmHg 5 kPa for high vacuum gauge or 10 mmHg 1 3 kPa for the standard vacuum gauges or 8mmHg 1 1 kPa for the low vacuum gauge 8 5 Low Vacuum Regulators ONLY 1 3 Occlude the fitting port Rotate the suction control knob fully clockwise increase Verify that the suction delivered does not exceed 150 mm Hg 20 kPa or the maximum suction requested by the clinician Note For setting the Suction level limit refer to Suction Level Limit Setting Low Models ONLY 8700 0006 000 Rev 3 8 Sercice Checkout Procedure 8 6 Bleed Test 1 2 Occlude the fitting port and set the vacuum level to 100 mm Hg 14 kPa Turn the selector switch to O Off and observe the gauge needle It must return to the zero range bracket or stop pin within 10 seconds 8 7 Leak Test Supply Side 1 2 Connect the supply vacuum tubing to port A of the Bubble Leak Tester Connect port B of the Bubble Leak Tester to the regulator adapter port Turn the mode selector switch to O Off Allow the fitting port to be open to air Wait 20 seconds No More than 6 bubbles should appear in the next ten seconds Impo
27. gulator s probe adapter and the wall outlet A WARNING Connect the vacuum regulator to the vacuum source only and check its operation before attaching the patient connection Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment Note For proper installation of Adapters Probes and Fittings see Appendix Connect the collection bottle s vacuum port to the regulator s fitting port or Overflow Safety Trap with the appropriate suction filter and vacuum tubing An Ohio Medical High Flow Suction Filter should be used between the collection container and regulator to prevent contamination of the regulator Use hospital supplied suction tubing between the end piece and the collection container and between the patient port and the patient minimum inside diameter is 6 mm 0 25 in 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 Hydrophilic Nipple Pkg of 20 6730 0350 800 Pkg of 200 6730 0351 800 Hydrophobic Nipple Threaded Pkg of 3 6730 0570 800 6730 0580 800 Pkg of 10 6730 0571 800 6730 0581 800 Pkg of 100 6730 0572 900 6730 0582 800 4 2 Attaching the Overflow Protection Device OPD AN CAUTION To help prevent aspirate from entering the regulator wall outlet and pipeline system as a result of misuse an Overflow Safety Trap should be attached prior to
28. 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 correct 3 Ball Vac Kote is a registered trademark of the Ball Aerospace Systems Division Loctite is a registered trademark of Loctite Corporation 8700 0006 000 Rev 3 10 1 Illustrated Parts 1 2 3 4 5 6 7 8 9 6700 0078 400 8700 0017 500 See Table 8700 0041 500 8700 0021 500 See table below 8700 0038 500 8700 0015 500 6700 0175 500 8700 0002 700 8700 0043 500 8700 0001 700 0210 0525 300 8700 0040 500 5 Screw PHH PNH 4 20 Plastite Knob Case Regulator Gauge Lens Drive Gear Occlude To Set Gaug
29. lace the o ring Replace gauge Replace Batteries Remedy _ Jiggle knob ii Verify actuator is installed properly ili Replace worn drive gear Replace cover if worn splines in well Replace Push To Set assembly Unblock port Reset float empty and disinfect the Overflow Protection Device Replace external filter Clean or Replace fitting Remedy i Check lid is secure on the collection container ii Check tubing connections Suction level cannot be adjusted Failure to push knob and rotate Regulator module is stuck in full OFF or full ON position Regulator module malfunction Push and rotate to set vacuum level Push and rotate knob counterclockwise to un stick See Regulator module malfunction under the Problem column in this section of the manual Suction level can be adjusted without pushing the knob in 11 Worn or broken drive gear Worn or broken splines in well Broken knob Digital Unit Only Replace drive gear Replace cover Replace knob 8700 0006 000 Rev 3 6 Troubleshooting Problem Possible Causes G Insufficient flow through 1 Partial blockage in wall supply 1 Confirm wall supply is open and air regulator flow meets minimum hospital requirements 2 Partial blockage in regulator 2 Perform the Flow Test in the Service Checkout Procedure section of this manual 3 Push to Set spring assembly 3 Remedy does not return blocking the i Jiggle knob flow path ii Replac
30. m 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 6 2 Determine a maintenance schedule based on data from your periodic inspections Follow the guidelines below 9 2 Recommended Maintenance Schedule tem Minimum Frequency Comments Service Checkout Procedure Every 24 months or as required Elastomeric parts O rings gaskets diaphragms internal filters 17 If the regulator does not pass refer to Troubleshooting Sec tion 6 Repair as needed Cleaning lubrication and replacement interval depends on hours of usage and environmental conditions Replace lubricate and repair as needed 8700 0006 000 Rev 3 9 3 Repair Policy AN WARNING Clean and sterilize all suction equipment before shipment or service to ensure transportation personnel and or service personnel are not exposed to any hazardous contamination CAUTION Do not steam autoclave or liquid sterilize the Continuous Vacuum Regulator Severe impairment to the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide A A CAUTION Only competent individuals trained in the repair of this equipment should attempt to service it Do not use malfunctioning equipment Make all necessary repairs Have the equipment repaired by qualified service personnel or by Ohio M
31. national 2 1 Note North American ANSI Vacuum Regulators Part numbers given are for PTS CVR without fittings or adapters 3 Specifications 3 1 Description 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 The PTS CVR is a lightweight compact unit used throughout the hospital primarily for pharyngeal tracheal suctioning airway management Various models provide regulated or full line vacuum for hospital suction procedures There are several models of the PTS CVR All models contain a vacuum gauge which indicates suction supplied by the regulator Each has a positive pressure safety relief valve to prevent pressurization by either failed injector vacuum venturi units or inadvertent cross connection to pressurized gasses In addition the Low PTS CVR models include a vacuum relief valve to limit maximum suction Some models operate in a regulated or non regulated MAX mode Others operate only in the regulated limited mode In the non regulated MAX mode the vacuum source is connected directly to the fitting port The regulator module is bypassed and full line vacuum is provided Mode Switch Vacuum Suction Control Knob Selector Gauge In the regulated limited mode the vacuum source is connected through the regulator module which functions as an automatic
32. nect the vacuum supply to the adapter port and occlude the fitting port 4 Be certain that the screws remain at an equal height by adjusting both low vacuum limiting screws the same amount and in the same direction Adjust the screws to supply a maximum vacuum of 150 mm Hg 20 kPa and not less than 130 mm Hg 17 kPa 8700 0006 000 Rev 3 7 3 2 Vacuum Relief Valve Adjustment Remove the cover Connect the supply vacuum to the adapter port Turn the mode selector switch to I ON Occlude the fitting port Slowly pull the regulator module away from the base Note the suction level at which the relief valve opens The relief valve should open at 165 mmHg 15 mmHg 22 kPa 2 kPa on units with limiting setscrews and 140 mmHg 5 mmHg 18 7 kPa 0 7 kPa for units without limiting setscrews 6 If adjustment is required grip the vacuum relief valve firmly with pliers and rotate the screw about 1 8 turn with a screwdriver Repeat the previous step and check the suction level at which the valve opens arwona 8 Note Clockwise rotation will increase the suction level at which the relief valve opens Counterclockwise rotation will decrease it 10 WARNING Excess Loctite may seal the steel ball to the seat This will disable the vacuum relief valve and may allow suction to exceed the preset limit 11 12 CAUTION When Loctite is used on the vacuum relief safety valve ensure that it only contacts the metal parts Loctite c
33. nstall it in the valve housing 3 Lubricate switch with a thin coat of Dow 111 on the overmolded area Place in manifold with grease side down 4 Add detent plate making sure the fingers are on either side of the switch shaft and pointing down 5 Place o ring on post coming up through center of detent plate and set gauge stand over o ring Tighten down with 4 screws 6 Place cylindrical white filter in corresponding cavity 7 Screw regulator module counter clockwise into manifold 8 Place PTS assembly in manifold directly below regulator module 9 Set actuator in brackets of the gauge stand and rest the loop on the top of the PTS assembly 10 Place gear over regulator post and rest it on the actuator 11 Place lens on gauge with single tab at the top and the two tabs at the lower portion of the gauge and set gauge into stand 12 Place cover strip in curved slot inside case 13 Mate the cover with the manifold With both thumbs positioned just below the lens press firmly to snap the lens in 14 Install the 4 cover screws 8700 0006 000 Rev 3 7 Service Disassembly Assembly 7 3 Suction Level Limit Setting Low Models ONLY WARNING This Low Vacuum Limit Setting Procedure must be followed when repairing Low Vacuum Regulators Failure to do this may result in suction exceeding the prescribed level The design of the low continuous vacuum regulator has been changed to eliminate the low vacuum limiting set screws
34. rtant 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 port of the vacuum regulator 8 8 Leak Test Patient Side 1 2 Connect the supply vacuum tubing to the regulator adapter port Connect the regulator fitting port to port A of the Bubble Leak Tester with tubing Allow port B of the Bubble Leak Tester to be open to air Rotate the suction control knob a minimum of one full turn clockwise increase No bubbles should appear in the next ten seconds Rotate the suction control knob fully counterclockwise decrease Turn the mode selector switch to On No bubbles should appear in the next ten seconds 16 9 Maintenance 9 1 General Equipment Maintenance of Suction A WARNING The Pre Use Checkout Procedure must be performed before using this equipment on each patient If the regulator fails any part of the Pre Use Checkout Procedure it must be removed from service and repaired by qualified service personnel A WARNING Clean and sterilize all suction equipment if contaminated before disassembly to ensure service personnel are not exposed to hazardous contamination Continuous Vacuum Regulators should be kept in use or used on a rotating basis Unused equipment may tend to deteriorate Maintenance of the vacuum piping system is as important as maintenance of
35. ry 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 should 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 other than Ohio Medical 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 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 1 Precautions Gin 1 aminmogs ww 2 1 3 GAULIONS asenon iinoa a NE 2 2 Scope 2 1 North American Vacuum Regulators pp 2 2 2 International Vacuum Regulators pp 2 3 Description and Specifications o DES CIP iOa 3 3 2 SPSCIICAIONS oirir iseina eed e 4 4 Operation 4 1 Equipment Set up ccccccccceceeeeeseeeeseeeeeesaeeeeeeees 5 4 2 Attaching the Safety Trap pp 5 4 3 Mode Sel
36. sipation of residual ethylene oxide gas absorbed by the material Aerate parts for 8 hours at 130 F 54 C A CAUTION Do not steam autoclave or liquid sterilize the Continuous Vacuum Regulator Severe impairment to the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide 8700 0006 000 Rev 3 5 Cleaning amp Sterilization AN CAUTION Sterilization with ethylene oxide mixtures Place the regulator in the vertical position and connect to a may cause crazing minute superficial cracking of supply vacuum of 500 mm Hg 10 mm Hg 67 kPa 1 3 some plastic parts Crazing will be more pronounced kPa when mixtures containing Freon are used Note The Vacuum Regulator should only be sterilized if it is contaminated or maintenance is to be performed 1 The regulator should be sterilized with the mode selector switch in the On position 2 The only acceptable method of sterilization is with ethylene oxide 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 Sterilization is not recommended as a standard procedure after each use 3 After each sterilization check the condition of the internal filter If the filter appears to have shrunk replace it before placing the regulator back in service 4 Adequately aerate the regul
37. the suction equipment The use of Collection Bottles with reliable shut off valves Overflow Safety Trap assemblies and disposable suction filters will protect the regulator 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 The flow rate measurement should meet local standards Routine maintenance and inspection are important to the performance of suction equipment The following is a recommended list for care of suction equipment after each patient use 1 Perform a thorough cleaning by washing all bottles tubing metal connectors etc and removing all residue 2 Wipe all exterior surfaces with a solution of water and mild detergent Perform a careful visual inspection Check that the High Flow Disposable Suction Filter is clean and in good condition 5 Check that all tubing is in good condition and connected securely to the correct ports 6 Check the floats in the Overflow Safety Trap and Collection Bottle for correct operation 7 Perform the Pre Use Checkout Procedure eo 9 2 Recommended Maintenance Schedule Ohio Medical vacuum regulators function for decades They are proven to provide trouble free service with minimum care We recommend the following to determine the maintenance schedule appropriate for each facility 1 Periodically as required but no less than annually inspect the overall condition of the vacuu
38. tient connection by failed injector vacuum venturi units or inadvertent cross connection to pressurized gases Gauge Range Regulated Suction 0 to 200 mm Hg o to 26 kPa 0 to 760 mm Hg 0 to 100 kPa 0 to 760 mm Hg 0 to 100 kPa 0 to 760 mm Hg 0 to 100 kPa 0 to 160 mm Hg 0 to 21 kPa 0 to 135 mm Hg 0 to 18 kPa When measured with an independent measuring device Vacuum Relief Valve Low Vacuum models ONLY Weight Less fittings Weight Low Vacuum models Less fittings Dimensions Less fittings Latex tubing 0 25 in 6 4 mm I D X 12 in 80 cm supplied Disposable tubing Available separate in some markets 6 mm I D X 450 mm 750 mm and 2M to connect regulator and collection bottle Disposable Suction Filter Environmental Specifications Operating Temperature Range Storage Temperature Range Operating and Storage Relative Humidity 8700 0006 000 Rev 3 140 mm Hg 5 mm Hg 18 7 kPa 0 7 kPa 11 02 312 grams 12 02 340 grams Height 5 7 inches 145 mm Width 3 0 inches 76 mm Depth 3 8 inches 96 mm 0 to full vacuum Flow dependent on source and setup 0 to full vacuum Flow dependent on source and setup 0 to full vacuum 0 to 100 Lom 650 mmHg 87 kPa 40 F 4 C to 120 F 49 C O F 18 C to 150 F 71 C 5 to 95 4 Operation 4 1 Equipment Set up Insert the probe into the vacuum wall outlet If the regulator is mounted elsewhere connect a vacuum supply hose between the re
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8700 0006 000 CVR Service Manual R3.indd BOC e