6700-0072-000 CVR service manual R5 Final.indd
Contents
1. Suction Control Knob 9 Maintenance 3 Rotate the suction control knob a minimum of one full turn clockwise increase No bubbles should appear in the next ten seconds 4 Rotate the suction control knob fully counter clockwise decrease 5 Turnthe mode selector switch to On No bubbles should appear in the next ten seconds Port B 1 4 ID Clear Tubing Sealed Water Bubble Leak Tester Bubble Leak Test Patient Side 9 1 General Maintenance of Suction Equipment WARNINGS A The pre use checkout procedure Section 4 5 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 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 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 outl2. 8 6 Bleed TeSt cc ccecccceecsseeccseeeeseeeeeeeeseenens 22 8 7 Leak Test Supply Side c cere 22 8 8 Leak Test Patient Side eee 23 9 Maintenance 9 1 General Maintenance of Suction EGUMEN aorersuroranr a e e 23 9 2 Recommended Maintenance Schedule 24 9 2 1 Maintenance Schedule a ca 24 93 Repair POW scccisvciccictenttbrahacttevancapioccesatennemers 24 9 4 Technical Assistance 24 9 5 Return INStructions cece ceeseeeeeeeee anes 24 10 Ordering Information 10 1 Mlu strated FP ATS iinne 25 10 2 Service RUS wintanecxasesatariasvolacesaiiactocnsiisarnoieees 26 Appendix Installation procedure for Adapters Probes and Fittings wascccasssertacensderceintoeneanaeincaueeacmagdnetans A 1 6700 0072 000 Rev 5 3 1 Precautions 1 1 Definitions Note A 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 injury to the patient or the operator exists A Alerts you to a warning or caution in the text MAX maximum High Flow High Vacuum High Flow Low Vacuum On O Off high flow high vacuum high flow low vacuum On Off 1 2 Warnings The pre use checkout procedure Section 4 5 Pre Use Checkout Procedure must be perf
3. connection to pressurized gases Ranges Gauge Range Standard Models High Models Low Models 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 ID X 12 in 80 cm supplied Disposable tubing Available separate in some markets 6 mm ID 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 0 to 200 mmHg 0 to 26 7 kPa 0 to 760 mmHg 0 to 101 3 kPa 0 to 160 mmHg 0 to 21 3 kPa Regulated Suction 0 to 760 mmHg 0 to 101 3 kPa 0 to 760 mmHg 0 to 101 3 kPa 0 to 135 mmHg 0 to 18 0 kPa When measured with an independent measuring device 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa 11 oz 312 grams 12 oz 340 grams Height 5 7 in 145 mm Width 3 0 in 76 mm Depth 3 8 in 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 LPM 650 mmHg 87 kPa 40 F to 120 F 42C to 49 C O F to 150 F 18 C to 71 C 5 to 95 6700 0072 000 Rev 5 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 regulator s probe ad
4. 2 and remove the cap 2 Remove the O rings 2 3 Observe the position of the diaphragm convolution to aid in assembly 4 Withdraw the diaphragm stem assembly from the housing 5 Remove the spring 6 Grasp the stem with your fingers and unscrew the stem screw 7 Remove the retainer diaphragm and piston from the stem all 1 O ring Stem A 2 O ring a wt f 8 9 3 Housing 7 Q 4 Stem 6 7 Se Fe 5 Spring 5 lt amp W BA ee 7 6 Piston a 7 Diaphragm 8 Retainer amp 9 Stem Screw 10 Cap 11 Cap Screw Regulator Module Parts and Descriptions 18 6700 0072 000 Rev 5 7 Service Disassembly and Assembly 7 4 2 Assembly 1 Return the diaphragm to its original position convoluted with the molded number facing the retainer 2 Assemble the diaphragm onto the retainer by lining up their center holes as shown in the diagram 3 Insert the piston into the diaphragm and ensure that the retainer mates with the recess in the piston 4 Insert the stem through the piston Holding the retainer diaphragm piston stem as an assembly with your fingers insert the stem screw and tighten 6 Place the spring in the housing 7 Insert the retainer diaphragm piston stem assembly through the spring and into the cavity in the housing Fit the diaphragm bead into the groove in the housing 8 Install the cap and the two cap screws 9 Apply a small amount of Dow Corning 111 grease to the O rings on
5. A If the vacuum regulator is repaired or disassembled in any manner the service checkout procedure Section 8 Service Checkout Procedure must be performed before using the equipment on a patient Clean and sterilize all suction equipment if contaminated before disassembly to ensure service personnel are not exposed to hazardous contamination If repairing or replacing a regulator module on a Low Vacuum Regulator you must perform the suction level limit setting procedure Section 7 3 Suction Level Limit Setting Low Models ONLY Failure to do this may result in suction exceeding the prescribed level CAUTION A 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 6700 0072 000 Rev 5 15 7 Service Disassembly and Assembly 1 2 Fon gt a 6 7 8 9 Cover Screw 4 Cover Assembly Mode Selector Switch Switch Plate Screw O ring Vacuum Relief Valve Low Models Only Vacuum Relief Valve amp O ring Low Models Only Gauge Assembly includes gauge O rings and lens Lens O ring 2 Gauge Regulator Module 10 Positive Pressure Safety Relief Valve 11 Filter Internal 12 Base 13 O ring Stem 14 O ring Regulator Module 16 6700 0072 000 Rev 5 7 Service Disassembly and Assembly Remove the four cover screws from the back of the regulator Carefully pull the cover assembl
6. Checkout Procedure 8 6 Bleed Test ie 22 8 7 Leak Test Supply Side Occlude the fitting port and set the vacuum levelto 4 Connect the supply vacuum tubing to port A of the 100 mmHg 13 3 kPa bubble leak tester Turn the selector switch to O Off and observe 2 Connect port B of the bubble leak tester to the the gauge needle It must return to the zero range regulator adapter port bracket or stop pin within 10 seconds 3 Turn the mode selector switch to O Off Allow the fitting port to be open to air 4 Wait 20 seconds No More than 6 bubbles should appear in the next ten seconds Important Prior to venting port A of the bubble leak tester to atmosphere i e turning the supply regulator off ensure the tubing from port B has been disconnected from the adapter port of the vacuum regulator Supply Vacuum Gauge 0 to 760 mmHg 0 to 101 3 kPa wal Vacuum Regulator Supply Regulator 500 mmHg 66 7 kPa Fitting Port Sealed 1 4 ID Clear Tubing Water Bubble Leak Tester Bubble Leak Test Supply Side 6700 0072 000 Rev 5 8 Service Checkout Procedure 8 8 Leak Test Patient Side 1 Connect the supply vacuum tubing to the regulator adapter port 2 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 Mode Selector Switch Tee Vacuum Regulator
7. MMHG cnstecvvertrcumistaniarcuins 6700 0050 200 North American Low 0 160 MMH sissrsccsscanancabvecdacartenens 6700 0050 202 North American High 0 760 MMHG cccccccceeeeesesteeees 6700 0050 201 International LOW 0 e 6700 0050 205 International High 6700 0050 204 Te MOS rener srer 6700 0087 500 8 O ring 2 Gauge 6700 0130 500 ine Whe 12 13 10 ordering information Regulator Module Standard High Models 6700 1225 800 Low Models sseceeeeeeeeees 6700 0428 800 Positive Pressure Safety Relief WIV GS erosie aaan 6700 0115 800 Filter Internal sicrie 0206 5159 300 Base North American Standard amp High Two amp Three Mode ee 6700 0018 203 North American Low 006 6700 0029 203 International LOW ccccceeeees 6700 0029 200 International High 6700 0018 200 O ring SlOM pe caccccesscncseaceaseceaeiecas 0210 0527 300 O ring Regulator Module 6700 0136 500 6700 0072 000 Rev 5 25 10 Ordering Information 10 2 Service Kits Standard and High Models 6700 0043 200 Includes the following parts O ring 2 Gauge Filter Internal Positive Pressure Safety Relief Valve Regulator Module Replacement Kit Low Models sis iesistessccvisssssnenaiexacenonsavecns 6700 0044 200 Includes the following parts O ring 2 Gauge Filter Internal Positive Pressure Safety Relief
8. Valve Regulator Module Replacement Kit O ring Vacuum Relief Valve Increase Label Universal Regulator Module Replacement Kit scssseseesesereeeees 6700 0030 700 Includes the following parts O ring Stem These parts are available O ring only in kit form If other Diaphragm parts are needed for re Stem Screw placement the entire Cap Screw 3 Module must be ordered 6700 1225 800 O rings and Filters Kit sssee 0221 5871 870 Includes the internal filter and 6 O rings Continuous Regulator Module 6 6700 0028 700 Low Cont Regulator Module 6 6700 0190 700 Regulator Module Replacement Parts Kit OY cacecvaraiarsdaneasecacienaserenauierens 6700 0031 700 The following kits for U S regulators only Standard Vacuum Gauge 4 06 0205 8689 870 High Vacuum Gauge 4 eeeeee 6700 0097 200 Low Vacuum Gauge 4 0 eeeeeee 6700 0098 200 Standard amp High Backplate 4 6700 0194 700 Low Backplate 4 ccincctteeneinbinwes 6700 0198 700 26 6700 0072 000 Rev 5 Installation procedure for Adapters Probes and Fittings All adapters probes and fittings should be sealed and installed properly to prevent leaks and to support the equipment when mounted Both vacuum regulator ports are 1 8 27 NPTF 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 prope
9. gauge debris 3 Gauge mechanism damaged 3 Replace gauge C Gauge indication but no 1 Blocked fitting port 1 Clean port suction is being delivered 2 Overflow Safety Trap shut off 2 Reset flow and or empty trap 3 Blocked external filter 3 Replace filter 4 Blocked fitting 4 Clean fitting D Suction level cannot be 1 Mode selector switch in 1 Switch to On adjusted position 2 Regulator module small O ring 2 Replace rubber components with failure regulator module replacement kit 3 Regulator module diaphragm 3 Replace rubber components with rupture regulator module replacement kit 4 Regulator module stem screw 4 Tighten stem screw loose E Insufficient flow through 1 Partial blockage in wall supply 1 Remedy regulator i Confirm wall supply open air flow meets minimum hospital requirements ii Unblock if necessary 2 Partial blockage in regulator 2 Remedy i Perform the flow test Section 8 2 Flow Test ii Clear blockage if necessary F Inaccurate gauge reading 1 Damaged gauge 1 Replace gauge 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 G With the fitting port occluded 1 Blocked filter and or orifice 1 Clear orifice and replace filter unable to decrease the 2 Damaged gauge 2 Replace gauge suction level and gauge needle does not return to zero when switched to O O
10. 0 7 kPa 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 Note Clockwise rotation will increase the suction level at which the relief valve opens Counter clockwise rotation will decrease it WARNING A 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 A 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 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 Valve S Body P 3a l Loctite a 242 A LO O ring GB Screw Vacuum Relief Valve w Magnet 7 4 Regulator Module WARNING A If repairing or replacing a regulator module on a Low Vacuum Regulator you must perform the suction level limit setting procedure Section 7 3 Suction Level Limit Setting Low Models ONLY Failure to do this may result in suction exceeding the prescribed level CAUTIONS A Do not lubricate any internal components of the regulator module A The cap screws can strip the regulator module housing threads if they are screwed in too tight 7 4 1 Disassembly 1 Remove the cap screws
11. SS fitting 3 Mode Switch 1 Insert trap into the regulator fitting MAX Situate the tubing in the desired Regulator Daemon Note Available on three mode vacuum regulators only 2 Turn the DISS wing nut ie clockwise to engage threads and tighten there is no O ring so the vacuum seal depends on a tight connection 10 6700 0072 000 Rev 5 4 4 Setting the Suction Level f WARNING A The regulator fitting port or patient Occlude or clamp tubing Turn the mode selector switch to On Rotate the suction control knob until the vacuum gauge indicates the required setting 9 TA Clamp connector must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction 4 5 Pre Use Checkout Procedure WARNINGS A 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 A Connect the vacuum regulator to the vacuum source only and check it s operation before attaching the patient connection A Connection to pressure sources even momentarily could injure the patient or operator CAUTION A Connection to pressure sources even momentarily could damage the equipment All tests must be performed with
12. W 0 760 mmHg 0 101 3 kPa 0 760 mmHg 0 101 3 kPa 0 135 mmHg 0 18 0 kPa 6 6700 0072 000 Rev 5 3 Description and Specifications 3 1 Description WARNING A 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 Continuous Vacuum Regulator 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 Continuous Vacuum Regulators 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 Continuous 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 routed directly to the fitting port The regulator module is bypassed and full line vacuum is provided Mode Selector Switch Vacuum Gauge Suction Control Knob Front and Side View In the regulated limited mode the vacuum source is connected through the re
13. a supply vacuum of 500 mmHg 66 7 kPa minimum fitting port The gauge needle 4 Operation Turn the mode selector switch to O Off Rotate the suction control knob one full turn clockwise increase f Clamp tubing to occlude the should not move Clamp Turn the mode selector switch to On Rotate the suction control knob fully counter clockwise decrease Clamp the connective tubing The gauge needle should not move Slowly open and close the clamped tubing to create various flow rates through the regulator Check that the suction level is maintained at 5 of full scale deflection when the tubing is clamped Clamp Release Clamp For Standard Two Mode Continuous go to step 11 6700 0072 000 Rev 5 11 4 Operation 9 High and Standard Three Mode Continuous ONLY 4 6 Patient Setup a Turn the mode selector to b Clamp the connective tubing and check that the gauge needle indicates the maximum available suction Make sure the pre use checkout procedure Section 4 5 Pre Use Checkout Procedure has been performed 2 Clamp the connective tubing and turn the mode c Turn the mode selector to On selector switch to On 3 Set the prescribed suction level WARNING A The regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than requir
14. al Component Cleaning CAUTION A 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 Section 8 Service Disassembly and Assembly instructions 2 All internal components with the exception of the gauge may be cleaned with a solution of warm water and mild detergent preferably an enzymatic cleaner 3 Dry all components with a lint free cloth before assembly 5 Cleaning and Sterilization 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 WARNING A 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 CAUTIONS A 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 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 contaminat
15. alibration gauge Calibration Gauge 760 mmHg 101 3 kPa 225 mmHg 30 kPa Flowmeter 80 LPM Service Checkout Test 20 6700 0072 000 Rev 5 8 3 Gauge Test Note All Ohio Medical gauges are supplied with an accuracy of 5 of full scale deflection throughout their range The table below is provided for reference Gauge Range Tolerance Standard Models 0 to 200 mmHg 10 mmHg 0 to 26 7 kPa 1 3 kPa High Models 0 to 760 mmHg 38 mmHg 0 to 101 3 kPa 5 1 kPa Low Models 0 to 160 mmHg 8 mmHg 0 to 21 3 kPa 1 1 kPa 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 8 3 1 High Vacuum Gauges ONLY 1 Connect the regulator s fitting port to the high calibration gauge with tubing 2 Turn 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 8 3 2 Standard and Low Vacuum Gauges ONLY 1 Connect the regulator s fitting port to the low calibration gauge with tubing 2 Turn the mode selector switch to On 3 Ensure that the gauge is in agreement with the low vacuum calibra
16. apter and the wall outlet WARNINGS A Connect the vacuum regulator to the vacuum source only and check its operation before attaching the patient connection A Connection to pressure sources even momentarily could injure the patient or operator CAUTION A Connection to pressure sources even momentarily could damage the equipment Note For proper installation of adapters probes and fittings see Appendix A 1 Connect the collection bottles vacuum port to the regulator s fitting port or overflow safety trap with the appropriate suction filter and vacuum tubing Vacuum Regulator 4 Operation 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 0 25 in 6 mm ISO 10079 3 section 5 1 2 states that the usable volume of the collection container shall not be less than 500 mL An Ohio Medical high flow suction filter should be used between the collection container and regulator to prevent contamination of the regulator Hospital supplied suction tubing must be used between the catheter and the collection bottle Recommended minimum inside diameter is 0 25 in 6 mm High Flow Suction Filters Hydrophilic Pkg of 20 6730 0350 800 Pkg of 200 6730 0351 800 Hydrophobic Tubing x 1 8 NPT x tubing nipple tubing nipple Pkg of 3 6730 0570 800 6730 0580 800 Pkg of 10 6730 0571 800 6730 0581 800 Pk
17. ed 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 to 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 regulator prior to disassembly shipment or use Aerate parts prior to reassembly 6700 0072 000 Rev 5 13 6 Troubleshooting Problem Possible Causes Remedy A No gauge indication and no 1 No supply vacuum 1 Correct supply problems suction in any setting 2 Kinked tube 2 Straighten tube 3 Poor connection 3 Check all connections and seals 4 Blocked adapter port 4 Unblock port 5 Blocked backplate 5 Clean with soap and water and pipe cleaner 6 Blocked adapter 6 Replace adapter 7 Blocked wall outlet 7 Unblock outlet B No gauge indication but 1 Blocked gauge pressure 1 Clean or replace gauge suction is being delivered sensing orifice 2 Gauge mechanism locked by 2 Clean or replace
18. ed suction 10 Low Continuous ONLY Clamp the connective tubing and rotate knob fully clockwise increase to verify the suction level does not exceed 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa 4 Turn the mode selector switch to O Off 5 Attach the connective tubing to the vacuum port of the collection container Patient Connective GaN Ln H 11 Reduce the suction level to zero and set the mode selector switch to O Off 12 6700 0072 000 Rev 5 6 Turn the mode selector switch to On Important The Low models do not deliver suction in excess of 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa 5 1 Cleaning WARNING A After patient use regulators contaminated Handle in accordance with your hospital s infection control policy may be 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 Intern
19. eeeeeeeeeeeeseeeees 10 4 4 Setting the Suction Level c eee 11 4 5 Pre Use Checkout Procedure 00 11 4 6 Patient Set Up eee eeeeseeeeeeeeseeeeees 12 5 Cleaning and Sterilization S Gleanings eee errs eer moreno re ener arene 13 5 1 1 Routine Exterior Cleaning 0 13 5 1 2 Internal Component Cleaning 13 5 2 SSH ZAwON sescsasivescedeastentecetartcvecccentetaasteuanss 13 6 Troubleshooting cncccssiccccsccreiccncacencesceneccceseteauserene 14 7 Service Disassembly and Assembly 7 1 Service Tools and Equipment 06 15 7 2 Continuous Vacuum Regulators AIMOD GS cccdisscecacsasd vaccanacedesnesratentnenecseaeasens 15 7 2 1 Disassembly sececccccccniscessdestnccentseentneresbus 15 22 ASSOMDY arrr rrasa 17 7 3 Suction Level Limit Setting Low Models ONY ede ta cca vaste cenesasutiteactch cevendeaten 18 7 4 Regulator Module ceesseeeeeeeeeeeeeees 18 FAA DISASSOMDONY skccttte catenin 18 7 4 2 Assembly ccccceecceeeeeeseeeeeeeteeeeeeeeeeees 19 Table of Contents 8 Service Checkout Procedure oy MM 10 eee ae ene nee eee cer ree eres eee ere 20 8 2 FOW VeShiscateeetscceciccite tad chntek a 20 8 3 Ga ge 2c e een ee eee eee e 21 8 3 1 High Vacuum Gauges ONLY 4 21 8 3 2 Standard and Low Vacuum Gauges ONE sc dcscssasticandecccdnerscsetesrevese 21 8 4 Reg lation TeStierrrirreracier iien 21 8 5 Low Vacuum Regulators ONLY eee 21
20. ets 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 4 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 6700 0072 000 Rev 5 23 9 Maintenance 9 2 Recommended Maintenance Schedule In addition to the Pre Use Checkout Procedure the following periodic maintenance should be performed 9 2 1 Maintenance Schedule Minimum Frequency Every 12 months Service Checkout Elastometric components O rings switch gasket regulator module diaphragm positive pressure safety valve and internal filter As required 9 3 Repair Policy WARNING A 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 CAUTIONS A Do
21. ff H No suction in any setting and 1 Positive pressure safety relief 1 Replace positive pressure safety relief whistling noise from inside the valve failure valve regulator 2 Vacuum relief valve failure low 2 Replace O ring and ensure that the models ONLY steel ball is present and clean 14 6700 0072 000 Rev 5 7 Service Disassembly and Assembly 7 1 Service Tools and Equipment CAUTION A 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 mmHg 10 mmHg 66 7 kPa 1 3 kPa amp 50 LPM open air flow minimum Supply vacuum regulator with gauge 760 mmHg 101 3 kPa Full Scale Low vacuum calibration gauge 225 mmHg 380 kPa full scale Ohio Medical P N 6700 0353 800 High vacuum calibration gauge 760 mmHg 101 3 kPa Full Scale Ohio Medical P N 6700 0352 800 50 LPM flowmeter Ohio Medical P N 6700 0355 800 Hexagonal allen wrench 3 32 Phillips head screwdriver No 2 Flat head screwdriver 1 4 Pliers Dow Corning 111 grease Ohio Medical P N 6700 0074 200 Loctite 242 removable thread locker Ohio Medical P N 0220 5016 300 Tubing clamp Bubble leak tester Tweezers filter remover Wooden tooth pick O ring remover Pipe cleaner Accuracy 1 of full scale deflection 7 2 Continuous Vacuum Regulators All Models 7 2 1 Disassembly WARNINGS
22. g of 100 6730 0572 900 6730 0582 800 Vacuum Port Disposable Suction Filter Patient Port Oe ee Safety Trap Equipment Set Up Connective Tubing Collection Bottle 6700 0072 000 Rev 5 9 4 Operation 4 2 Attaching the Overflow Safety 4 3 Mode Selection Trap OST CAUTION On Suction can be adjusted with the suction control knob A To help prevent aspirate from entering the regulator wall outlet and pipeline system an overflow safety trap should be attached prior to its use Aspirate gt nN in the regulator wall outlet and pipeline system 2 Mode Switch 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 Standard fitting 3 Mode Switch On 1 Raise the sleeve and insert the trap into the regulator fitting O Off No suction is supplied to the patient 2 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 J gt nN Regulat oe 2 Mode Switch The trap should rotate freely to allow the desired tubing i positioning Sleeve 3 Lower sleeve to lock trap in position 3 Mode Switch O Off Maximum full line vacuum is supplied to the patient DI
23. gulator module which functions as an automatic 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 pre set 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 adjustment of suction to the patient 2 Mode Selector Switch Allows quick 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 Adapter Port Fitting Port 6700 0072 000 Rev 5 7 3 Description and Specifications 3 2 Specifications Gauge Flow Rate Positive Pressure Safety Relief Valve Accuracy 5 of full scale deflection 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 patient connection by failed injector vacuum Venturi units or inadvertent cross
24. ly 10 Install O rings onto the stem and housing Retainer Stem Set Screw Piston Diaphragm convoluted Diaphragm Assembly 6700 0072 000 Rev 5 19 8 Service Checkout Procedure WARNING A If the vacuum regulator is repaired or 8 2 Flow Test disassembled in any manner the service 1 Connect the regulator s fittin he fl checkout procedure Section 8 Service oe ore a reine vee ith tubing Checkout Procedure must be performed before with tubing using the equipment on a patient 2 Rotate the suction control knob fully clockwise increase Important This entire service checkout procedure 3 Turn the mode selector switch to On and verify must be performed in numerical order that the flow rate exceeds 30 LPM 8 1 Set up 4 Three Mode ONLY Turn the mode selector switch to and verify that the flow rate exceeds 30 1 Verify that there is 500 mmHg 10 mmHg 66 7 pitt kPa 1 3 kPa vacuum on the supply gauge 5 Turn the mode selector switch to O Off 2 The supply open flow must be 50 LPM minimum 6 Disconnect the flowmeter 3 Connect the supply vacuum to the adapter port Mode Supply Vacuum gauge Selector aaa 0 to 760 mmHg 0 to 101 3 kPa Switch hag Supply vacuum Regulator Supply vacuum set to 500 mmHg 10 500 mmHg 66 7 kPa mmHg 66 7 kPa 1 3 kPa Minimum and Open flow of 50 LPM Minimum awn 2 EE i 7 a Nn _ Re r 1 l l l Occluded High Vacuum Low Vacuum C
25. n 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 If the vacuum regulator is under the warranty 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 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 24 6700 0072 000 Rev 5 10 1 Illustrated Parts Description Part Number 1 Cover Screw 4 cccccecceeesssseeeteeeees 6700 0152 400 2 Cover Assembly Low MOOG Scrinis eussi neii 6700 0629 850 Standard High Models 6700 0628 850 Description Part Number T SWIC ciadessucenthaxaacacaasesseiareniangaiee 6700 0078 500 2 Switch Plate Three Mode cc ccsecceeeeeeeeees 6700 0193 500 Two MOG S LOW vccssciccrrctesgeectar borers 6700 0194 500 3e OCKOW eani e EEKE ARRES 6700 0152 400 4 O ring Vacuum Relief Valve Low Models Onlly cee 6700 0135 500 5 Vacuum Relief Valve amp O ring Low Models Onlly eeeee 6700 0660 850 6 Gauge Assembly Includes gauge O rings and lens North American Standard 0 200
26. 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 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 Medical 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 Section 8 Service Checkout Procedure to ensure that it is functioning properly and complies with the published specifications If the regulator does not pass the service checkout procedure Section 8 Service Checkout Procedure refer to Section 6 Troubleshooting Repair as necessary Cleaning and replacement interval will depend greatly on hours of usage and environmental conditions Replace and repair as necessary 9 4 Technical Assistance If technical assistance is required contact Ohio Medical technical support or field operations listed on the back cover 9 5 Return Instructions 1 Call 866 549 6446 for a authorization returned goods 2 Clean and sterilize the vacuum regulator Package the vacuum regulator securely for protection preferably i
27. ons Place the internal filter into the proper cavity and push until it hits the bottom of the base Place the regulator module into the cover with the screw thread facing the knob Align the protruding ears at 3 and 9 o clock and rotate the suction control knob clockwise until the threads engage Install the snap fit lens by placing one of the retaining tabs over the edge of the gauge face and then press lightly until the other tab snaps onto the gauge face Rotate the lens to confirm proper installation Install the gauge assembly by lubricating the gauge O rings with a thin coating of Dow Corning 111 grease and push the gauge into the base mount Ensure that the gauge is properly aligned Place the cover assembly onto the base and push together until the base and back of the cover are flush Install the 4 cover screws 17 7 Service Disassembly and Assembly 7 3 Suction Level Limit Setting Low Models ONLY WARNING A 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 _ Remove the cover Connect the supply vacuum to the adapter port Turn the mode selector switch to On Occlude the fitting port a FY DN 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 135 mmHg 5 mmHg 18 0 kPa
28. oration Genuine replacement parts manufactured or sold by Ohio Medical must be used for all repairs Read completely through each step in every procedure before starting the procedure any exceptions may result in a failure to properly and safely complete the attempted procedure Abbreviations CCW Counter clockwise Anti clockwise Full Line Vacuum inHg Inches of Mercury kPa Kilopascals kPa x 7 50 mmHg LPM Liters per minute mmHg Millimeters of mercury mmHg x 133 kPa mL Milliliters 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 NPT National Pipe Thread USA NPTF National Pipe Thread Female USA MPTS Multi Purpose Therapy Stand gal Gallon PTFE Polytetrafluoroethylene 2 6700 0072 000 Rev 5 1 Precautions AA Definitions So aiticstctnnvsecdsansmudeiessesdonteceonessanannens 4 142 WANTING Senesnio 4 E3 2105 cee ee ee ee eee reer 5 1 4 Intended USC cecceeeeeeseeeeeeeeeeeeeeeeeeeeeeeee 5 2 Scope 2 1 North American Vacuum Regulators 6 2 2 International Vacuum Regulators 60 6 3 Description and Specifications Oil DOSP sri regerer EE 7 3 2 SPO CHICATONG cei setcicis scan cavsanticsinee treated duutvncanars 8 4 Operation 4 1 Equipment SQW vcccisctnete wetntieteecieeeen 9 4 2 Attaching the Safety Trap ceeeeeeeeees 10 4 3 Mode Selection cceceecee
29. ormation is under license from Ohio Medical Corporation Any use other than that authorized by Ohio Medical Corporation is prohibited Ohio Medical Ohio Medical Corporation and the Ohio Medical logo are registered trademarks of Ohio Medical Corporation ISO is a registered trademark of International Organization for Standardization 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 Dow Corning is a registered trademark of Dow Corning Corporation 6700 0072 000 Rev 5 11 2012
30. ormed 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 Connect the vacuum regulator to the vacuum source only Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment Always connect the regulator to the vacuum source and check its operation before attaching the patient connection The fitting port of the regulator must be occluded when setting the prescribed suction level This prevents the patient from receiving higher than required suction levels 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 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 Clean and sterilize all suction equipment if contaminated before disassembly to ensure service personnel are not exposed to hazardous contamination 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
31. p O 110 Medical Corporation always there for life Continuous Vacuum Regulators Service Manual Ron 6700 0072 000 Rev 5 11 2012 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 malfunctioning Product should not be used Parts that are broken missing plainly worn destroyed or contaminated should be replaced immediately Should such repair or replacement become necessary Ohio Medical recommends that a telephonic or written request for 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 anyone not having such qualifications service advice be made to the nearest Ohio Medical Service Office This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ohio Medical or altered without the prior written approval of Ohio Medical s Safety 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 alterations by anyone other than Ohio Medical Corp
32. parts for 8 hours at 130 F 54 C If the vacuum regulator is repaired or disassembled in any manner the service checkout procedure Section 8 Service Checkout Procedure must be performed before using the equipment on the patient The low vacuum limit setting procedure Section 7 3 Suction Level Limit Setting Low Models ONLY must be followed when repairing low vacuum regulators Failure to do this may result in suction exceeding the prescribed level 4 6700 0072 000 Rev 5 1 3 Cautions Do not lubricate any internal components of the regulator module Do not use any Loctite products to seal the fitting and 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 wall outlet and pipeline equipment 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 checkout procedure Section 8 Service Checkout Procedure Not for Field or Transport use The categorie
33. rly Prior to installing the adapter probe or fitting seal the thread with Teflon PTFE tape or one of the following lubricants Dow Corning 111 Ohio Medical P N 6700 0074 200 Ball Vac Kote 37951M Ohio Medical P N 0220 0091 300 6700 0072 000 Rev 5 Appendix CAUTION A Donotuse any Loctite products to seal the threads or products which contain Methacrylate Ester as an active ingredient 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 Additional torque is applied only until orientation is correct A 1 io Medical Corporation always there for life North America United States Customer Service Distribution Center Technical Support Sales and Service Equipment Service Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA P 1 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 OxygenCare Ltd 2 Holfeld Business Park Kilmacanogue Co Wicklow Ireland Tel 353 1 2769700 Fax 353 1 2764970 2012 Ohio Medical Corporation This document contains information that is proprietary and confidential to Ohio Medical Corporation Use of this inf
34. s 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 1 Precautions 1 4 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 6700 0072 000 Rev 5 5 2 Scope This service manual contains service maintenance and parts information on all models of the Continuous Vacuum Regulator 2 1 North American Vacuum Regulators Note Part numbers given are for vacuum regulators without fittings or adapters Standard Three Mode Standard Two Mode Low Continuous High Three Mode Continuous Continuous 6700 1227 900 Continuous 6700 1224 900 6700 1225 900 0 135 mmHg 6700 1226 900 0 200 mmHg FULL VAC 0 200 mmHg FULL VAC 0 760 mmHg 2 2 International Vacuum Regulators Important International vacuum regulators comply with the requirements of ISO 10079 3 and are CE marked Note Part numbers given are for vacuum regulators without fittings or adapters Three Mode High Continuous Two Mode High Continuous Two Mode Low Continuous 6700 1229 900 6700 1230 900 6700 1233 900 CCW CCW CC
35. tion 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 and 80 mmHg 5 3 and 10 7 kPa for the standard and low models and 140 mmHg 18 7 kPa for standard model only 4 For the standard gauge ONLY Rotate the suction control knob fully clockwise increase and verify its 8 Service Checkout Procedure 8 4 Regulation Test 1 Disconnect the calibration gauge and occlude the fitting port If using a High Vacuum Regulator set its gauge to 300 mmHg 40 0 kPa If using a Low or Standard Vacuum Regulator set its gauge to 100 mmHg 13 3 kPa o Open and close the fitting port several times 4 With the fitting port occluded the gauge should return to the setting listed in step 2 within a tolerance of 38 mmHg 5 1 kPa for high vacuum gauges or 10 mmHg 1 3 kPa for standard vacuum gauges or 8 mmHg 1 1 kPa for low vacuum gauges 8 5 Low Vacuum Regulators ONLY 1 Occlude the fitting port 2 Rotate the suction control knob fully clockwise increase 3 Verify that the suction delivered does not exceed 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa or the maximum suction requested by the clinician Note For setting the suction level limit refer to suction level limit setting Section 7 3 Suction Level Limit Setting Low Models ONLY reading is in the FULL VAC range 6700 0072 000 Rev 5 21 8 Service
36. y off the back body To remove the gauge assembly grasp the assembly and pull straight out The snap fit lens can also be removed if applicable for replacement Pull down plastic tab with right index finger while holding gauge Snap Fit Lens Removal To remove the regulator module from the cover assembly rotate the suction control knob counter clockwise until the regulator module is free Using tweezers remove the filter Replace with a new filter Grasp the positive pressure safety relief valve and pull it from the back body Remove the mounting screw from the switch plate assembly and remove the switch plate and mode switch Low models ONLY Grasp the vacuum relief valve and pull it from the back body 6700 0072 000 Rev 5 7 2 2 Assembly CAUTION A 12 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 screw Place the positive pressure safety relief valve in position and push onto the back body Low models ONLY Lubricate the vacuum relief valve O ring and install it in the valve housing Lubricate the switch gasket surface with a thin coating of Dow Corning 111 grease Place the mode switch on the base with the arrow at 12 o clock Place the switch plate onto the switch so that the O Off is under the arrow Install and tighten the mounting screw Test the mode switch at all positi
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