PTS Continuous Vacuum Regulator Service Manual
Contents
1. Analog 1230 Digital 1337 Analog 1229 Digital 1329 Analog 1232 Digital 1332 Analog 1235 Digital 1335 High Two Mode High Three Mode Low Two Mode Low Two Mode Continuous Continuous Continuous Continuous Adult Adult Neonatal Pediatric 6 8700 0006 000 Rev 8 10 2014 3 Description and Specifications 3 1 Description 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 mode Others operate only in the regulated mode In the non regulated mode the vacuum source is connected directly to the fitting patient port The regulator module is bypassed and full line vacuum is provided In the regulated mode the vacuum source is connected through the regulator module which functions as an automatic valve Turning the suction control knob adjusts the position of the regulator module and a2. 110 Medical Corporation always there for life Vacuum Regulator Push To Set Continuous PTS CVR Service Manual Adult Pediatric Neonatal C A S S Two Mode ANSI ISO Analog Analog Adult Standard 1225 Adult High 1230 Adult High 1330 Neonatal 1232 C A S S 1227 Pediatric 1235 Neonatal 1231 nat Digital Pediatric 1234 Adult High 1337 Digital Neonatal 1332 Adult Standard 1325 Pediatric 1335 Adult High 1430 C A S S 1327 Neonatal 1331 Pediatric 1334 Three Mode ANSI ISO Analog Analog Adult Standard 1224 Adult High 1229 Adult High 1226 Digital Digital Adult High 1329 Adult Standard 1324 Adult High 1326 8700 0006 000 Rev 8 10 2014 User Responsibility This Product will perform as described in this operating manual and accompanying labels and or inserts when assembled operated maintained 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 worn distorted or contaminated should be replaced immediately For service advice Ohio Medical recommends that a telephone request be made to the nearest Ohio Medical Regional Service Center This product and any of its parts should only be repaired using written instructions provided by Ohio Medical or
3. 6 3 Description and Specifications 3 1 3 2 Description 7 Specification S 8 4 Cleaning Disinfection and Sterilization 4 1 Cleaning and 9 4 1 1 Routine Exterior Cleaning 9 4 1 1 1 Approved Cleaning Solutions 9 42 Sterllizatioli 9 5 Troubleshooting 10 6 Service Disassembly and Assembly 6 1 6 2 6 3 6 4 6 5 Service Tools and Equipment 12 Continuous Vacuum Regulators All Models 12 6 2 1 Disassembly 12 6 2 2 Assemibly ee tts 12 Suction Level Limit Setting PED NEO C A S S Models ONLY derent 13 6 3 1 Vacuum Relief Valve Adjustment 13 6 3 2 Vacuum Limiting Set Screw Adjustment PED and NEO Units ONLY 13 6 3 2 1 Pediatric Unit 13 6 3 2 2 Neonatal 13 Regulator Module 13 6 4 1 Disassembly 14 6 4 2 Assembly 14 Digital Gauge vet tt teta ended 14 6 5 1 Removal of Batteries 14 6 5 2 Inserting 14 Table of Co
4. ON mode e Adult High models ONLY the unit should produce a minimum of 40 LPM at maximum 2 Connect the fitting patient port to port A of the bubble vacuum in ON mode leak tester with tubing Allow port B of the bubble leak Connect the fitting patient port to the 50 LPM flowmeter tester to be open to air Move the mode selector switch to 3 Rotate the suction control knob a minimum of one full Set the unit to 100 mmHg 5 mmHg 12 7 kPa 0 7 turn clockwise increase No bubbles should appear kPa in the next ten seconds Release the suction control knob and verify that the 4 Rotate the suction control knob fully counter clockwise flow rate exceeds 25 LPM decrease Adult models ONLY Push and rotate the suction 5 Move the mode selector switch to ON No bubbles control knob fully clockwise should appear in the next ten seconds Release the suction control knob and verify that the flow rate exceeds 40 LPM Fitting Patient Port Bubble Leak Test Patient Side 7 8 Flow Test Note All PTS CVR models should produce a minimum of 25 LPM from the patient port given the following conditions e supply open flow is 80 LPM minimum supply vacuum pressure is 500 mmHg 10 mmHg The unit has fittings on the fitting patient and adapter probe ports with minimum inner diameters of 0 140 e Theunitis either directly connected to the vacuum Source or connected w
5. module Whistling buzzing noise from the unit Blocked bleed hole orifice Clean bleed hole orifice 32 Gauge responds slowly Damaged gauge assembly Replace gauge assembly 6 to changes in suction failed bleed down test Damaged Clogged Supply side or Patient Replace fittings if damaged clogged side fittings Retighten Torque if found loose Damaged regulator case Replace regulator case 3 Damaged diaphragm Replace diaphragm 30 Vacuum relief valve activates below specified range Damaged loose set screw Replace Adjust set screw 8700 0007 400 PED and NEO ONLY Damaged vacuum relief assembly Replace vacuum relief assembly 6700 0045 700 Vacuum relief valve Damaged vacuum relief assembly Replace vacuum relief assembly and follow does not activate at Section 6 3 suction level limit setting specified range PED and NEO ONLY 8700 0006 000 Rev 8 10 2014 11 6 Service Disassembly and Assembly 6 1 Service Tools and Equipment CAUTION Use of lubricants other than recommended may degrade plastic or rubber components The following items should be on hand during any service procedure e Supply vacuum 500 mmHg 10 mmHg 67 kPa 1 3 kPa amp 80 LPM open air flow minimum Supply Vacuum Regulator with Gauge 760 mmHg 101 3 kPa Full Scale Low Vacuum Calibration Gauge 225 mmHg 30 kPa Full Scale Ohio Medical P N 6700 0353 800 e High Vacuum Calibration Gauge 760 mmHg 101 3 kPa Full Scale Ohio Med
6. model 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa for the PED model and 140 mmHg x 5 mmHg 18 7 kPa 0 7 kPa for the C A S S model Note For setting the suction level limit refer to Section 6 3 Suction Level Limit Setting PED NEO C A S S Models ONLY 7 6 Bleed Test 1 Occlude the fitting patient port and set the vacuum level to 100 mmHg 13 3 kPa Move 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 digital gauge will return to O 7 7 Leak Test 7 7 1 Supply Side 1 Important Connect the adapter probe port to port A of the bubble leak tester Allow the fitting patient port to be open to air Move the mode selector switch to O OFF Connect port B of the bubble leak tester to the supply vacuum regulated to 500 mmHg 66 7 kPa Wait 20 seconds No more than 6 bubbles should appear in the next ten seconds Prior to venting port A of the bubble leak tester to atmosphere i e turning the supply regulator off ensure the tubing from port has been disconnected from the adapter probe port of the vacuum regulator Test Gauge Adaptor Probe Bubble Leak Test Supply Side 8700 0006 000 Rev 8 10 2014 7 7 2 Patient Side 1 Connect the supply vacuum tubing to the adapter probe port 7 Service Checkout Procedure e The unit is set to 100 mmHg 5 mmHg 12 7 kPa 0 7 kPa in
7. 1 25 8700 0005 100 Knob Label 1 i 8700 0038 500 Cover Strip Switch 1 26 8700 0056 500 Plug 1 8 8700 0015 500 Actuator Occlude To Set 1 27 See table below Label 1 9 6700 0175 500 O Ring 2 013 Nitrile 1 28 8700 0006 500 Cap 1 10 8700 0002 700 OTS Assembly 1 29 8700 0046 500 Cap Plug 1 11 8700 0043 500 Support Bracket Actuator 1 30 8700 0008 500 Diaphragm 1 12 8700 0001 700 Assembly Reg Mod 1 9115 8700 0007 500 Piston with stem 1 13 0210 0525 300 O Ring 9 32 OD x 5 32 15 1 16W 1 32 8700 0011 400 Spring 0 475 ID 1 14 8700 0040 500 Plate Detent 1 33 8700 0012 400 Spring 0 246 ID 1 15 8700 0016 500 Selector Switch Overmolded 1 34 8700 0005 500 Housing 1 16 Seetable below Plug Pull Tab 1 8700 0023 500 O Ring 018 Nitrile 1 17 See table below Vacuum Relief Assembly 1 36 8700 0024 500 Quad Ring 006 Nitrile 1 18 See table below O Ring 2 014 Nitrile Buna N 1 8700 0006 000 PTS CVR Service Manual 1 19 6700 0115 400 Relief Valve Positive Pressure 1 Item 6 Item 6 Item 3 Gauge Vacuum Gauge Vacuum Model Case Regulator Analog ANSI Digital Analog ISO 1224 1324 8700 0012 500 8700 0002 400 VR DGP 200MM 1225 1325 8700 0022 500 8700 0002 400 VR DGP 200MM 1226 1326 1229 8700 0012 500 8700 0022 400 VR DGP 760MM 8700 0023 400 1231 1331 1235 8700 0053 500 8700 0024 400 VR DGP 160MM 8700 0025 400 1234 1334 1232 8700 0053 500 8700 0024 400 VR DGP 160MM 8
8. ONLY 1 Connect the regulator s fitting patient port to the high calibration gauge with tubing 2 Move the mode selector switch to ON 3 Ensure that the gauge is in agreement with the high vacuum calibration gauge within the 38 mmHg 5 1 kPa tolerance Recommended test points are 100 300 and 450 mmHg 13 3 40 0 and 60 0 kPa 4 Push and rotate the suction control knob fully clockwise and ensure that the vacuum calibration gauge reads at least 450 mmHg 60 0 kPa 5 Three mode models ONLY Move the mode selector switch to MAX and ensure that the vacuum calibration gauge reads at least 450 mmHg 60 0 kPa 6 Push and rotate the suction control knob fully counter clockwise decrease and verify the gauge reading decreases to zero 7 3 2 Standard and PED NEO C A S S Vacuum Gauges ONLY 1 Connect the regulator s fitting patient port to the low calibration gauge with tubing 2 Move the mode selector switch to ON 3 Ensure that the gauge is in agreement with the low vacuum calibration gauge within x 10 mmHg 1 3 kPa for the standard model For the PED NEO C A S S models ensure that the calibration gauge is within 8 mmHg 1 1 kPa Recommended 8700 0006 000 Rev 8 10 2014 15 7 Service Checkout Procedure test points are 40 and 80 mmHg 5 3 and 10 7 kPa for the standard PED NEO C A S S models and 140 mmHg 18 7 kPa for standard model only For the standard model ONLY Push and rotate
9. clockwise into manifold 8 Place PTS assembly in manifold directly below regulator module 12 8700 0006 000 Rev 8 10 2014 6 Service Disassembly and Assembly 9 Set actuator in brackets of the actuator support bracket 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 support bracket 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 6 3 Suction Level Limit Setting PED NEO C A S S 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 6 3 1 Vacuum Relief Valve Adjustment 1 Remove the cover see Section 6 2 1 Disassembly 2 Connect the supply vacuum to the adapter probe port 3 Connect an external vacuum test gauge to the patient port 4 Move the mode selector switch to ON Slowly rotate the regulator module to increase the vacuum level Note the suction level at which the relief valve opens The relief valve should open at 140 mmHg 5 mmHg 18 7 kPa 0 7 kPa on the external test gauge 6 If adjustment is required grip th
10. repaired or disassembled in any manner the service checkout procedure must be performed before using the equipment on a patient After patient use if regulator is contaminated then handle in accordance with you hospital s infection control policy To reduce transportation personnel and or service personnel exposure to hazardous contamination DO NOT ship any suction equipment that has been contaminated 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 Connection to positive pressure sources such as oxygen and medical air even momentarily could injure the patient or operator Ohio Medical will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling To help prevent aspirate from entering the device wall outlet and pipeline equipment a safety trap should be attached prior to its use Aspirate in the regulator wall outlet and pipeline equipment may impair its operations The use of the safety trap and suction filter will help prevent this and extend the life of suction equipment 1 3 CAUTION Do not use any Loctite products or any products which contain Methacrylate Ester as an active ingredient to seal the threads on the adapters probes and fittings Use of lubricants other than recommended may degrade plastic or rubber components D
11. to uneven support water dirt and mechanical shock and temperature extremes Ohio Medical Suction equipment has not been tested to comply with the specific requirements of these categories Note Ohio Medical requests that parties acquiring this device Report the device s purchase receipt in trade return after sale loss destruction or retirement Contact your Ohio Medical customer service representative to obtain manual updates Authorized Service Center Customer Service Call 1 866 549 6446 or 1 847 855 0500 for service and repair information 8700 0006 000 Rev 8 10 2014 5 2 Scope This service manual contains service maintenance and parts information on all models of the Push To Set Continuous Vacuum Regulator 2 1 ANSI Vacuum Regulators North American Analog 1225 Digital 1325 Analog 1224 Digital 1324 Analog 1330 Digital 1430 Analog 1227 Digital 1327 Standard Two Mode Standard Three Mode High Two Mode Standard Two Mode Continuous Continuous Continuous Continuous Adult Adult Adult C A S S Analog 1226 Digital 1326 Analog 1231 Digital 1331 Analog 1234 Digital 1334 High Three Mode Low Two Mode Low Two Mode Continuous Continuous Continuous Adult Neonatal Pediatric 2 2 SO Vacuum Regulators International
12. 00 F 1 847 855 6218 Ohio Medical Corporation Authorized Representative EC REP OxygenCare Ltd 2 Holfeld Business Park Kilmacanogue Co Wicklow C Ireland Tel 353 1 2769700 Fax 353 1 2764970 2014 Ohio Medical Corporation This document contains information that is proprietary and confidential to Ohio Medical Corporation Use of this information is under license from Ohio Medical Corporation Any use other than that authorized by Ohio Medical Corporation is prohibited Ohio Medical Corporation is a registered trademark and Push to Set is a trademark of Ohio Medical Corporation ANSI is a registered trademark of American National Standards Institute ISO is a registered trademark of International Organization for Standardization NFPA is a registered trademark of National Fire Protection Association Inc Lexan is a registered trademark of Sabic Innovative Plastics IP B V Company Virex is a registered trademark of S C Johnson amp Son Inc Kleenaseptic is a registered trademark of Metrex Research Corporation Betco is a registered trademark of Betco Corporation Cavicide is a registered trademark of Metrex Research Corporation Vac Kote is a registered trademark of the Ball Aerospace amp Technology Corp Loctite is a registered trademark of Henkel Corporation Teflon is a registered trademark of E I duPont de Demurs and Company Oxequip is a registered trademark of Allied Healthcare Products Inc Do
13. 700 0025 400 1330 1430 1230 8700 0022 500 8700 0022 400 VR DGP 760MM 8700 0023 400 Item 17 Item 18 Item 16 Vacuum Relief O Ring 2 014 Item 27 Model Plug Pull Tab Assembly Nitrile Buna N Label 1224 1324 8700 0039 500 N A N A N A 1225 1325 8700 0039 500 N A N A N A 1226 1326 8700 0039 500 N A N A N A 1231 1331 N A 6700 0045 700 6700 0135 500 8700 0036 102 1234 1334 N A 6700 0045 700 6700 0135 500 N A 1330 1430 8700 0039 500 N A N A N A Color Case for 2 Mode Digital Regulators Only and C A S S 3 Mode Pediatric Neonatal Item 3 Purple 8700 0065 500 8700 0092 500 8700 0108 500 8700 0124 500 Red 8700 0066 500 8700 0093 500 8700 0109 500 8700 0125 500 Blue 8700 0067 500 8700 0094 500 8700 0110 500 8700 0126 500 Yellow 8700 0068 500 8700 0095 500 8700 0111 500 8700 0127 500 Lt Blue 8700 0069 500 8700 0096 500 8700 0112 500 8700 0128 500 Pink 8700 0070 500 8700 0097 500 8700 0113 500 8700 0129 500 20 8700 0006 000 Rev 8 10 2014 9 Ordering Information TAS 8700 0006 000 Rev 8 10 2014 21 22 Notes 8700 0006 000 Rev 8 10 2014 Notes 8700 0006 000 Rev 8 10 2014 23 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 08
14. Ohio Medical P N 6700 1987 800 or equivalent 2 Apply appropriate torque 4 0 ft Ib 5 4 N m minimum to 10 0 ft Ib 13 6 N m maximum 3 Adapters Probe and fittings which are not keyed for specific Patient Connection orientation should be torque approximately 6 0 ft Ib 8 1 Port Bottom N m 4 Adapters Probes and fittings that are keyed to specific orientation must be torque initially to 4 0 ft Ibs 5 4 N m Additional torque is applied only until orientation is correct Make sure wall adapter are installed to specific orientation so that they are mount straight on wall 6 The regulator is now ready to be place in service on your suction system 8700 0006 000 Rev 8 10 2014 19 9 Ordering Information 9 1 Illustrated Parts Item Part Number Description Qty Item Part Number Description Qty 1 6700 0078 400 Screw PHH PNH 4 20 Plastite 5 20 0206 5159 300 Plug Filter 1 25 8700 0017 500 Knob 1 21 6700 0121 400 Orifice Continuous Vacuum Regulator 1 3 See Table Case Regulator 1 22 8700 0009 700 Manifold Assembly 1 4 8700 0041 500 Gauge Lens 1 23 6700 0151 400 Screw Self Tap 6 Pan Head 4 5 8700 0021 500 Drive Gear Occlude To Set 1 24 8700 0016 100 Serial Number Label 1 6 See table below Gauge Vacuum
15. a x 0 3 kPa 6 3 2 2 Neonatal Unit 1 Adjust the regulator until the unit s gauge reads 100 mmHg 13 3 kPa 2 Rotate the set screw located above the regulator knob clockwise until it stops against the regulator module and then place one drop of Loctite 242 onto the set screw 3 Turn the regulator counter clockwise then clockwise until it stops against the set screw Ensure that the gauge reads 100 mmHg 5 mmHg 13 3 kPa 0 7 kPa and that the relief valve does not activate For the digital unit ensure that the gauge reads between 99 mmHg and FULL 13 2 kPa and FULL 6 4 Regulator Module 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 8700 0006 000 Rev 8 10 2014 13 6 Service Disassembly and Assembly 6 4 1 Disassembly 1 Remove the quad ring from the piston stem and the O ring from the housing Lubricate or replace if needed 2 Lift and pull tabs to pry off and remove the cap 3 Peel the diaphragm from the piston head 4 With the piston head facing down lift the housing to separate 5 Remove springs from the piston stem 6 4 2 Assembly 1 With the piston head facing down place the springs on the piston stem 2 Place the housing over the piston and slide the piston stem into the housing Place the quad ring on the tip of the piston stem Place the O ring on t
16. acuum regulator is covered under warranty include the warranty information that came with the device and a copy of the invoice 5 Call toll free 866 549 6446 or 1 847 855 0500 and ask customer service for an RMA number to include with your shipment 6 Ship the vacuum regulator prepaid Write your return address and billing address information on the package or letter that comes with the package For Warranty and non warranty repairs mail the package to Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA RMA In other locations contact your nearest Ohio Medical office or authorized Ohio Medical distributor 8 6 Installation Procedure for Adapters Probes and Fittings CAUTIONS Do not use any Loctite amp products or any products which contain Methacrylate Ester as an active ingredient to seal the threads on the adapters probes and fittings All Ohio Medical regulators are supplied with 1 8 NPT female ports The standard port facilitates simple adaptation to any quick disconnect system Fittings are available from Ohio Medical to adapt to your quick connect system We recommend you Wall Adapter purchase the appropriate fittings with your regulator at the time Port Rear of purchase The fittings will then be factory installed prior to shipping In the event that you must assemble or disassemble fittings please follow these instructions 1 Prior to installing the fittings wrap the thread with Teflon tape
17. ale C A S S 0 160 mmHg 0 21 3 KPA 5 Full scale 1 Full scale Physical 6 7 H x 2 8 W x 4 8 D 17 02 cm x 7 1 cm x 12 2 cm 1 Ib 4 oz 0 57 kg Battery Two 2 3 AA batteries 3 6V 1 6 Ah lithium without fittings at full increase setting depending on supply vacuum and open air flow full scale deflection full range at 22 C Positive Pressure Safety Relief Valve Neonatal ENVIRONMENTAL SPECIFICATIONS Operating Temperature Range 50 to 104 F 10 to 40 C Storage Temperature Range 13 to 158 F 25 to 70 C Operating and storage Relative Humidity 5 to 95 RH Non condensing Ingress Protection Ratings IP 20 8 8700 0006 000 Rev 8 10 2014 4 Cleaning Disinfection and Sterilization 4 1 Cleaning and Disinfection WARNING After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy 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 4 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 and or an approved cleaning solution 4 1 1 1 Approved Cleaning Solutions e Sodium Hypochlorite 0 5 Bleach M
18. 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 12345 This alpha character indicates the year of product manufacture and when the serial number was assigned L 2007 M 2008 2009 etc I and are not used Safety Instructions This manual provides you with important information about the Push To Set Continuous Vacuum Regulator PTS CVR To ensure the safe and proper use of this device READ and UNDERSTAND all of the safety and operating instructions IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS OR HAVE ANY QUESTIONS CONTACT YOUR SUPERVISOR DEALER OR THE MANUFACTURER BEFORE ATTEMPTING TO USE THE DEVICE Intended Use The vacuum regulator is intended to be used in the medical facility as a means to evacuate media i e fluids from the body DO NOT use this vacuum regulator for anything other than its intended use 2 8700 0006 000 Rev 8 10 2014 1 Precautions TAY Definitloris en eee ert 4 1 2 Wamitlgs iiuniiieie 5 1 3 Cautlons iecit dere ia cece sina 5 2 Scope 2 1 ANSI Vacuum Regulators North American 6 2 2 180 Vacuum Regulators International
19. d Supply side or Patient Replace fittings if damaged clogged side fittings Retighten Torque if found loose Knob fails to return when pushed Push and rotate the knob 2 if stuck Replace actuator 6 drive gear 5 Regulator Case 3 OTS assembly 10 Unit fails to provide Knob stuck at OFF position all the way Push and Rotate Knob 2 to clock wise vacuum at patient port counter clock wise direction direction in all modes Damaged Regulator Module Regulator Module Assembly 12 Clogged external filter Replace external filter Overflow protection device is shut off Check Reset float Replace Overflow protection device Loose or incorrect set up Set up unit correctly without any leak Aspirant draw into unit Follow your facilities procedures for handling contaminated products DO NOT SEND UNIT BACK TO THE MANUFACTURER Gauge assembly is not properly aligned Ensure gauge assembly 6 is properly aligned Missing Damaged O Rings Replace O Rings 9 Gauge doesn t respond to changes in suction Gauge assembly is damaged Replace gauge assembly 6 Digital Unit Only Digital Unit Only Depleted batteries Replaced Gauge 6 Batteries Unable to push and rotate knob Push and rotate knob 2 if stuck Replace actuator 6 drive gear 5 Regulator Case 3 OTS assembly 10 Damaged OTS assembly Replace OTS assembly 10 Regulator module is stuck in full OFF or full Rotate the knob 2 to free the Regulator ON position Module Ass
20. diaphragms hours of usage and environmental conditions Replace internal filters lubricate and repair as needed 8 3 Repair Policy WARNING To reduce transportation personnel and or service personnel exposure to hazardous contamination clean and disinfect all suction equipment before shipping for service CAUTION Do not steam autoclave or liquid sterilize the PTS CVR Severe impairment to the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide 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 18 8700 0006 000 Rev 8 10 2014 8 Maintenance 8 4 Technical Assistance If technical assistance is required contact Ohio Medical technical support at 1 857 855 0500 or toll free at 866 549 6446 8 5 Return Instructions 1 Clean and disinfect 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 Ifthe v
21. e 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 Note Clockwise rotation will increase the suction level at which the relief valve opens Counter clockwise rotation will decrease it 7 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 8 Re attach the cover see Section 6 2 2 Assembly 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 CAUTION When Loctite is used on the vacuum relief safety valve ensure that it only contacts the metal parts Loctite causes many plastic parts to deteriorate 6 3 2 Vacuum Limiting Set Screw Adjustment PED and NEO Units ONLY 6 3 2 1 Pediatric Unit 1 Adjust the regulator until the unit s gauge reads 135 mmHg 18 0 kPa 2 Rotate the set screw located above the regulator knob clockwise until it stops against the regulator module and then place one drop of Loctite 242 onto the set screw 3 Turn the regulator counter clockwise then clockwise until it stops against the set screw Ensure that the gauge reads 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa and that the relief valve does not activate For the digital unit ensure that the gauge reads 135 mmHg x 2 mmHg 18 0 kP
22. embly 12 Snap cap separated from regulator module Reassemble snap cap 28 onto regulator housing module housing 34 Replace snap cap 28 and or regulator module housing 34 Replace Regulator Module Assembly 12 Damaged Missing spring inside regulator Replace Regulator module assembly 12 module assembly Damaged Missing O ring Quad ring on Replace O ring 35 and or Quad ring 36 regulator module Damaged Diaphragm inside regulator Replace Diaphragm 30 or regulator module module assembly 12 Damaged Regulator Module Assembly Replace Regulator module assembly 12 10 8700 0006 000 Rev 8 10 2014 Suction level cannot be adjusted 5 Troubleshooting Damaged Diaphragm inside regulator Replace Diaphragm 30 or regulator module module assembly 12 Erratic gauge movement Damaged Missing O ring Quad ring on Replace O ring 35 and or Quad ring 36 resulting from regulator regulator module adjustment Gauge assembly is damaged Replace gauge assembly 6 Excessive force applied Rotate the knob 2 to free the Regulator Knob stuck in full OFF Module Assembly 12 or full ON position Damaged drive gear Replace drive gear 5 Suction level can Damaged actuator Replace actuator occlude to set 6 be adjusted without Damaged Knob Replace knob 2 pushing the knob in Damaged gauge assembly Replace gauge assembly 6 Gauge won t zero Need to apply grease on stem on regulator Apply grease on stem 31
23. he housing Fold the diaphragm and place it on the piston head D a P Q into place 6 5 Digital Gauge Note Both batteries are positioned with the positive side facing up relative to the display 6 5 1 Removal of Batteries 1 Remove digital gauge as described in Section 6 2 1 Disassembly 2 Using a small flat head screwdriver push batteries out at a 45 angle Place the cap on the housing and press until it snaps 6 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 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 14 8700 0006 000 Rev 8 10 2014 Important This entire Service Checkout Procedure must be performed in numerical order 7 1 Set up 1 Verify that there is 500 mmHg 10 mmHg 66 7 kPa 1 3 kPa vacuum on the supply gauge 2 The supply open flow must be 80 LPM minimum 3 Connect the supply vacuum to the adapter probe port Mode Selector Switch Supply Vacuum Gauge 0 760 mmHg 0 101 3 kPa Supply J Vacuum Supply Vacuum Reg 500 mmHg set to 500 mmHg 10 mmHg 64 kPa 1 3 kPa 67 kPa minimum and open flow of 80 LPM minimum 2 XQ i il Occluded High Vacuum Low Vacuum Flowme
24. ical P N 6700 0352 800 e 80LPM Flowmeter e Phillips Head Screwdriver No 2 e Flat Head Screwdriver 1 4 inch e Tubing Clamp e Bubble Leak Tester Tweezers Filter Remover Wooden Tooth Pick O ring Remover Phillips head screwdriver No 1 Dow Corning 111 grease Ohio Medical P N 6700 0074 200 Loctite 242 removable thread locker Ohio Medical P N 0220 5016 300 Stop watch or vacutimer Ohio Medical P N 6700 0438 800 e Open end adjustable wrench e 10 LPM flowmeter Accuracy 1 of full scale deflection 6 2 Continuous Vacuum Regulators All Models 6 2 1 Disassembly 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 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 Note See Section 9 1 Illustrated Parts 1 Remove the four cover screws from the back of the regulator 2 With regulator facing up carefully pull the cover assembly off the back body 3 To remove the gauge assembly gra
25. ith a tube no more than 4 in length with a minimum inner diameter of 0 25 The unit is connected to a flowmeter with a tube no more than 4 in length with a minimum inner diameter of 0 25 8700 0006 000 Rev 8 10 2014 17 8 Maintenance 8 1 General Maintenance of Suction Equipment 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 WARNING If the unit has been contaminated clean and disinfect all suction equipment before disassembly PTS CVR should be kept in use or used on a rotating basis Internal parts of unused equipment may tend to deteriorate 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 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 NFPA 99 and or ISO 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 Keep connecting tubing fit
26. ixture of 13 fl oz of bleach to 1 gallon 128 fl oz tap water e Isopropyl Alcohol 70 e Hydrogen Peroxide 3 e Cavicide Ready to use full strength 4 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 Section 7 Service Checkout Procedure WARNING Following sterilization with ethylene oxide parts should be quarantined in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material Aerate parts for 8 hours at 130 F 54 C Follow your hospital sterilization procedure CAUTION Do not steam autoclave or liquid sterilize the intermittent vacuum regulator Severe impairment to the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide CAUTION Sterilization with ethylene oxide mixtures may cause crazing minute superficial cracking of some plastic parts Crazing will be more pronounced when mixtures containing Freon are used Note The vacuum regulator should only be sterilized if it is contaminated or maintenance is to be performed 8700 0006 000 Rev 8 10 2014 9 5 Troubleshooting Mode Selector Switch is at O OFF position Move mode selector switch 34 to desired mode No Supply Vacuum Check Hospital vacuum level should be at least 500 mmHg 66 7 KPA Damaged Clogge
27. llows 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 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 Maximum full line vacuum is supplied to the patient 3 Vacuum Gauge The suction level to the patient is displayed during use Mode Selector Switch Vacuum Gauge Adapter Probe Port Suction Control Knob Fitting Patient Port 8700 0006 000 Rev 8 10 2014 7 3 Description and Specifications 3 2 Specifications Performance 80 LPM 80 LPM 80 LPM 80 LPM 80 LPM Located in the vacuum supply line to prevent pressurization of the patient connection by failed injector vacuum Venturi units or inadvertent cross connection to pressured gases Standard Li Fulbscale Pediatric 1 Full scale 0 160 mmHg 0 21 3 KPA 5 Full scale 1 Full scale 0 100 mmHg 0 13 3 KPA 5 Full scale 1 Full sc
28. ntents 7 Service Checkout Procedure GA area 15 7 2 Push To Set Test 15 53 Gauge lest eee eet 15 7 3 1 High Vacuum Gauges ONLY 15 7 3 2 Standard and PED NEO C A S S Vacuum Gauges ONLY 4 ir rcnt et rdi 15 7 4 Regulation Test etd ees 16 7 5 Maximum Vacuum Test PED NEO C A S S Models 16 7 6 Bleed Test 16 TD OAK Tests 16 f Supply SIde uidit eter 16 7 7 2 Patient Side eee 17 7 8 FOW iso a iex mane 17 8 Maintenance 8 1 General Maintenance of Suction Equipment 18 8 2 Recommended Maintenance Schedule 18 8 2 1 Maintenance Schedule 18 9 9 Repair Polly cmd rs 18 8 4 Technical 19 8 5 Return Instructions 19 8 6 Installation Procedure for Adapters Probes and Fittings 19 9 Ordering Information 9 1 Illustrated Parts esee 20 8700 0006 000 Rev 8 10 2014 3 1 Precautions 1 1 Definitions Note Note provides additional information to clarify a point in the text Important An Important statement is similar to a note but of greater emphasis CAUTION A CAUTION statement is used when the possibility of damage to the equipment exists WARNING A WARNING statement is used when the possibility of injur
29. o not steam autoclave or liquid sterilize the regulator Severe impairment to the operation of the 1 Precautions regulator will result The only acceptable method of sterilization is with gas ethylene oxide Sterilization with ethylene oxide mixtures may cause crazing minute superficial cracking of some plastic parts Crazing will be more pronounced when mixtures containing Freon are used Following sterilization with ethylene oxide parts should be quarantined in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material Aerate parts for 8 hours at 54 C 130 F Follow your hospital sterilization procedure Do not use harsh chemical or cleaning solution Do not spray cleaners directly onto suction regulators Only use chemical recommended in this manual If any evidence of damage is found repair as necessary or contact your authorized service provider Connection to positive pressure sources such as oxygen and medical air even momentarily could damage the equipment The suction control knob must be completely pushed in to adjust the vacuum level Failure to do so may damage the vacuum regulator Not for transport use The categories of field and transport user are specifically defined in ISO 10079 3 Field means use at accidents or emergencies outside a hospital Transport means use in ambulances cars and airplanes These situations may expose the equipment
30. sp the assembly and pull straight out The snap fit lens can also be removed if applicable for replacement 4 Remove actuator and PTS assembly To remove the regulator module from the manifold assembly rotate the regulator module clockwise 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 screws from the actuator support bracket and remove the support bracket detent plate and selector switch 9 Low models ONLY Grasp the vacuum relief valve and pull it from the back body 6 2 2 Assembly CAUTION To prevent stripping the plastic threads place the screw in the hole and turn counter clockwise until it drops into the original thread then tighten the screws 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 install it in the valve housing 3 Lubricate switch with a thin coat of Dow Corning 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 actuator support bracket over O ring Tighten down with 4 screws 6 Place cylindrical white filter in corresponding cavity 7 Screw regulator module counter
31. ter Calibration Gauge Calibration Gauge 50 LPM 760 mmHg 101 3 kPa 225 mmHg 30 kPa 7 2 Push To Set Test 1 Connect the 10 LPM flowmeter to the patient port 2 Move the mode selector switch to ON 3 Set 200 mmHg 26 6 kPa on the gauge and keep the knob pushed in For the pediatric unit set at 135 mmHg 18 0 kPa for the neonatal unit set at 100 mmHg 13 3 kPa and for the C A S S unit set at 140 mmHg 18 7 kPa 4 Make certain leakage at the patient port connection is no more than 1 LPM 5 While observing the flowmeter with the knob still pushed in rotate the knob Leakage should be no more than 1 LPM Release the knob and move the mode selector switch to O OFF 7 Service Checkout Procedure 7 3 Gauge Test Note Analog gauges are supplied with an accuracy of 5 of full scale deflection throughout their range See step 4 of Section 7 4 Regulation Test 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 Digital gauge should read 0 when no suction is applied No calibration required on digital gauges Note When checking the accuracy of the gauge on the analog unit be sure that the calibration gauge has an accuracy of 1 of full scale deflection or better 7 3 1 High Vacuum Gauges
32. the suction control knob fully clockwise Ensure that the vacuum calibration gauge reads at least 450 mmHg 60 0 kPa and that the gauge on the unit is in the FULL VAC range Push and rotate the suction control knob fully counter clockwise decrease and verify the gauge reading decreases to zero 7 4 Regulation Test 1 2 Remove any equipment attached to the patient port If using a high vacuum regulator set its gauge to 300 mmHg 40 0 kPa If using a standard PED NEO C A S S vacuum regulator set its gauge to 100 mmHg 13 3 kPa Open and close the fitting patient port several times to create various flow rates through the regulator With the fitting patient port occluded the gauge should return to the setting listed in step 2 within the following tolerances For analog units the gauge should return to 10 mmHg 1 3 kPa for the standard model 8 mmHg x 1 1 kPa for the PED NEO C A S S models and 38 mmHg x 5 1 kPa for the high model For digital units the gauge should return to 2 mmHg x 0 3 kPa for the standard PED C A S S models 1 mmHg x 0 1 kPa for the NEO model and 8 mmHg x 1 0 kPa for the high model 7 5 Maximum Vacuum Test PED NEO C A S S Models ONLY 1 2 16 Occlude the fitting patient port Rotate the suction control knob fully clockwise increase Verify that the suction delivered does not exceed 100 mmHg x 5 mmHg 13 3 kPa x 0 7 kPa for the NEO
33. tings and adapters probes 5 Check that all tubing is in good condition and clean connected securely to the correct ports 2 Wipe all exterior surfaces with a solution of water and 6 Check the floats in the Overflow Protection Device mild detergent or approved cleaning solutions and collection canister for correct operation 3 Perform a careful visual inspection of the vacuum 7 Perform the Pre use Checkout Procedure regulator 4 Check that the high flow disposable suction filter is clean and in good condition 8 2 Recommended Maintenance Schedule 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 vacuum regulator Test gauge accuracy Section 7 3 Gauge Test and perform the pre use checkout procedure See PTS CVR Instructions for Use for the Pre use Checkout Procedure If the regulator does not pass refer to troubleshooting Section 5 Troubleshooting 2 Determine a maintenance schedule based on data from your periodic inspections Follow the guidelines below 8 2 1 Maintenance Schedule tem Minimum Frequency Comments Service Checkout Every 24 months or If the regulator does not pass refer to troubleshooting Section Procedure as required 5 Troubleshooting Repair as needed Elastomeric parts O rings As required Cleaning lubrication and replacement interval depends on gaskets
34. w Corning is a registered trademark of Dow Corning Corporation 8700 0006 000 Rev 8 Venturi is a registered trademark of Talley Group Ltd 10 2014
35. y to the patient or the operator exists High Flow High Vacuum high flow high vacuum High Flow Low Vacuum high flow low vacuum ON on O OFF off A Consult Instructions for Use Serial Number udi Manufacturer Abbreviations Used In This Manual CCW Counter clockwise decrease CW Clockwise increase CVR Continuous Vacuum Regulator MAX Full Line Vacuum inHg Inches of mercury kPa Kilopascals kPa x 7 50 mmHg LPM Liters per minute mmHg Millimeters of mercury mmHg x 0 133 kPa mL Milliliters C Degrees Celsius F Degrees Fahrenheit N m Newton Meter N m x 0 737 ft lb ft Ib 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 Polytetrafluoroethylene PTS Push To Set ETO Ethylene Oxide IFU Instructions for Use 4 8700 0006 000 Rev 8 10 2014 1 2 Warnings This device should be repaired only by qualified Ohio Medical or Ohio Medical trained qualified personnel using only Ohio Medical recommended parts There are risks associated with using anything other than Ohio Medical parts Ohio Medical will assume no responsibility for incidents which may occur if the product was not repaired in accordance with procedures authorized by Ohio Medical If the vacuum regulator is
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