Ohio Legacy Surgical/Free-Flow Vacuum Regulator Service Manual
Contents
1. For U S A Warranty and Non Warranty Repairs mail the package to Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 RMA In other locations contact your nearest Ohio Medical office or authorized Ohio Medical distributor 9 6 Disposal Instructions Dispose of vacuum regulator in accordance with local regulations 6700 0088 000 Rev 6 23 10 Ordering Information 10 1 Illustrated Parts Item amp Description 1 oie N aoe ON oO 12 13 24 Part Number Screw Socket Head Cap 4 40 X 1 2 wrsspssationeciel natigniasaters 6700 0170 400 Locking Cam ices tircende 0212 1705 300 Washer Flat 28 OD 125 ID 6700 0174 400 Washer Spring cceeeeeeeeeeeees 6700 0148 400 Increase Label North American 6700 0250 100 International ccccccceeseeeees 0206 5154 300 Control Knob cccceeeeeeesseeees 0206 5187 300 Regulator Cover eesccceecceee 6700 0198 500 Control Shatin nicasianacee 0206 5188 300 SNAP Fit Lens scrcccrssceseecssvsneeessearnes 6700 0087 500 O rings 2 Gauge eeeeeeeeee 6700 0130 500 Gauge Assembly Includes gauge O ring and lens North American Standard 6700 0050 200 North American High 5 6700 0050 201 International High e 6700 0050 204 Tubing 425 OD 2 scscsiceutiasertees 0206 5186 300 Adapter 3 aces csendtencuiateentacennasd 6700 0173 400 5 OL 32. A To reduce service personnel exposure to hazardous contamination clean and disinfect all suction equipment before disassembly Surgical Free Flow 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 outlets should be performed The flow rate measurement should meet local standards 9 2 1 Maintenance Schedule Minimum Frequency Every 4 months If the regulator does not pass the service checkout procedure Section 8 Service Checkout Procedure refer to Section 6 Troubleshooting of this manual Repair as necessary O Rings Inspect every 4 months Replace every 24 months Service Checkout Procedure Internal Filters Inspect every 4 months 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 3
3. nio Medical Corporation always there for life Surgical Free Flow Vacuum Regulators Service Manual Surgical Free Flow tM te a ey Surgical Free Flow Re ed North American North American High Standard L Surgical Free Flow been p International High Rony 6700 0088 000 Rev 6 User Responsibility Safety Instructions This manual provides you with important information about the Surgical Free Flow Regulators 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 REFER TO THIS SERVICE MANUAL CONTACT YOUR SUPERVISOR DEALER OR THE MANUFACTURER BEFORE ATTEMPTING TO USE THE DEVICE Receiving Inspection Remove product from package and inspect for damage If product is damaged DO NOT USE and contact your dealer or equipment provider WARNINGS A This device is to be used ONLY by persons who have been properly trained on the operation of the device Incorrect use of this device may cause serious injury to a patient 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 A This device should ONLY be used for high flow high vacuum pressure applicat
4. 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 9 4 Technical Assistance If technical assistance is required contact Ohio Medical technical support listed on the back cover 9 Maintenance 9 5 Return Instructions 1 Call for a Return Material Authorization RMA number before sending any items for warranty and or non warranty repair 1 866 549 6446 2 Clean and sterilize the vacuum regulator 3 Package the vacuum regulator securely for protection preferably in the original container 4 Include a letter describing in detail any difficulties experienced with the vacuum regulator Include the person title and telephone number to contact for functional questions 5 If the vacuum regulator is under 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
5. clamped tubing to create various flow rates through the regulator Ensure that the suction level is maintained when the tubing is clamped A Always connect the regulator to the vacuum source and check its operation before attaching the patient connection Clamp Before the vacuum regulator is used it must be tested S A for correct operation as outlined below All tests must eN be performed with the regulator in its normal vertical Release operating position and with a minimum supply vacuum Clamp of 450 mmHg 60 0 kPa 1 Turn the mode selector switch to O Off 2 Rotate the suction control knob one full turn clockwise increase 9 Reduce the suction level to zero and set the mode selector switch to O Off 3 Clamp tubing to occlude the fitting port The gauge needle should not move XV SERA 5 eao Clamp 4 With the tubing still clamped set the mode selector switch to On 5 The gauge needle should not move 6 Rotate the suction control knob fully anti clockwise decrease S Qa
6. enclosure Unscrew the two retaining screws and remove the regulating bar and bellows 7 Remove the valve tube from the recessed enclosure 8 Remove the adapter and fitting ports and associated O rings 9 Pull the internal filter out of the socket using a pair of tweezers 10 Loosen the screw that holds the selector switch Detail Back Cover assembly in position and pull the selector switch assembly out of the base 6700 0088 000 Rev 6 17 7 Service Disassembly and Assembly 7 3 Assembly CAUTION A To prevent stripping the plastic threads place 18 the screw in the hole and turn counter clockwise until it drops into the original threads then tighten the screw Lubricate the adapter and fitting port O rings Assemble the adapter and fitting ports with appropriate O rings to the base Install a new filter Connect the valve tube and install the bellows and regulating bar to the base Install the rear window Use the locking wrench to tighten the two screws Connect the two small tubes from the bellows to the base Lubricate the selector switch assembly O rings and fit into the base assembly Tighten the retaining screw which holds the selector switch assembly in place To prevent damage to the plastic base do not over tighten the screw Lubricate the gauge assembly O rings Fit the gauge into the base assembly 8 Place the knurled end of the control shaft through its hole in the front cover a
7. 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 AAA A 12345 This alpha character indicates the year of product manufacture and when the Serial number was assigned Y 1995 Z 1996 A 1997 etc I and O are not used CAUTIONS A Only competent individuals trained in the repair of this equipment should attempt to service it A Detailed information for more extensive repairs is included in this service manual A Not for field or transport use The categories of Field and Transport Use are specifically defined in ISO 10079 3 Field means accidents or emergencies outside the hospital Transport means use in ambulances cars and airplanes These situations may expose the equipment to uneven support dirt water mechanical shock and temperature extremes Ohio Medical suction equipment has not been tested to comply with the specific requirements of these categories MAX maximum High Flow High Vacuum high flow high vacuum pressure Surgical Free Flow high vacuum high flow regulator On vacuum On O Off vacuum Off mmHg Millimeters of Mercury kPa Kilopascal mL Milliliter mm Millimeter g grams LPM Liters per minute in Inch C Degress Celsius F Degrees Fahr
8. 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 9 2 Recommended Maintenance Schedule In addition to the pre use checkout procedure the following periodic maintenance should be performed Replace as necessary to minimize in use failures Replace as necessary Replacement interval will depend greatly on hours of usage and condition of operating environment Valve Tube Inspect every 4 months Replace as necessary High Flow Disposable Suction Replace after each patient use Replace more frequently if flow Filter deteriorates 22 6700 0088 000 Rev 6 9 3 Repair Policy WARNING A Clean and disinfect all suction equipment before shipment for service to ensure transportation personnel and or service personnel are not exposed to any hazardous contamination CAUTIONS A Do not steam autoclave or liquid sterilize the Surgical Free Flow 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
9. Sterilization 5 1 Cleaning and Disinfection WARNING A After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy 5 1 1 Routine Exterior Cleaning Routine cleaning of the regulator is recommended as a standard procedure after each use Wipe all exterior surfaces with a solution of water and mild detergent and or an approved cleaning solution 5 1 1 1 Approved Cleaning Solutions Virex Quaternary Ammonium 0 2 Mixture of 1 fl oz of Virex to 1 gallon 128 fl oz tap water using Virex 128 e Kleenaseptic Full strength from spray can e Bleach Sodium Hypochlorite 0 5 Mixture of 13 fl oz of Clorox household bleach to 1 gallon 128 fl oz tap water e Betco TB Plus Mixture of 1 fl oz to 1 gallon 128 fl oz tap water e Glutaraldehyde e Isopropyl Alcohol 70 e Hydrogen Peroxide 3 e Cavicide Ready to use full strength 5 1 2 Internal Component Cleaning CAUTION A Cleaning the gauge may cause damage which will result in inaccurate readings 1 To disasssemble the unit refer to Section 7 Service Disassembly and Assembly for instructions 2 All internal components with the exception of the gauge may be cleaned with a solution of warm water and mild detergent 3 Dry all components with a lint free cloth before assembly 4 Perform service checkout procedure Section 8 Service Checkout Procedure 5 2 Sterilization Sh
10. kPa aun 500 mm Hg Vacuum Regulator Suction Supply Vacuum Control 450 mmHg 60 0 kPa Knob minimum and open flow of 80 LPM minimum _ Las Ea a ma aa 7 gt Se ax ae S N paian a SS a wo Pa SS m a gt Bas j 3 l le Occluded High Vacuum Calibration Gauge Low Vacuum 760 mmHg 101 3 kPa Calibration Gauge Flowmeter 225 mmHg 30 0 kPa 50 LPM Service Checkout Tests 6700 0088 000 Rev 6 19 8 Service Checkout Procedure 8 1 Set up 1 Verify that there is a minimum of 450 mmHg 60 0 kPa vacuum on the supply gauge 2 The supply open flow must be 50 LPM minimum 3 Connect the supply vacuum to the adapter port 8 2 Flow Test 1 Connect the regulator s fitting port to the flowmeter with tubing 2 Set the mode selector switch to On and rotate the suction control knob fully clockwise increase 3 Verify that the flow rate exceeds 30 LPM 4 Set the mode selector to O Off 5 Disconnect the flowmeter 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 0 to 200 mmHg 10mmHg Vacuum 0 to 26 7 kPa 1 3 kPa High 0 to 760 mmHg 38 mmHg Vacuum 0 to 101 3 kPa 5 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 Gauge needl
11. regulator bar automatically opens to maintain suction at the preset level When the flow requirement decreases the regulator bar automatically closes to maintain suction at the preset level The same mechanism compensates for changes in supply vacuum to automatically maintain the preset suction level This unique design adds reliability and extended service life because it isolates the regulating apparatus Mode Selector Switch Vacuum Gauge Suction Control Knob i FI C Surgical Free Flow and gauge from the vacuum circuit preventing damage from aerosols and contaminants For added durability the regulator is housed in an impact resistant case All models contain a vacuum gauge which indicates suction supplied by the regulator Both High Vacuum 0 to 760 mmHg 0 to 101 3 kPa and Standard 0 to 200 mmHg 0 to 26 7 kPa options are available The Surgical Free Flow Vacuum Regulator is available with a wide variety of direct mounting and bracket mounting configurations These configurations enable the regulator to be used with virtually any centrally piped system The regulator can be easily disassembled for maintenance and cleaning 1 Suction Control Knob Allows adjustment of suction to the patient 2 Mode Selector Switch Allows quick mode changes a O Off No suction is supplied to the patient b On Suction can be adjusted with the suction control kno
12. 580 800 Pkg of 10 6730 057 1 800 6730 0581 800 Pkg of 50 6730 0572 800 6730 0582 800 Patient Port Vacuum Regulator Connective Tubing Disposable Suction Filter Surgical Free Flow S I Collection Bottle Overflow Safety Trap EN all Underwater Seal Line Equipment Set up 6700 0088 000 Rev 6 9 4 Operation 4 1 1 Attaching the Overflow Safety Trap OST CAUTION A To help prevent aspirate from entering the regulator 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 their operation The use of the safety trap and suction filter will help prevent this and extend the life of suction equipment Trap fitting 1 Raise the sleeve and insert the trap into the regulator fitting 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 The trap should rotate freely to allow the desired tubing positioning 3 Lower the sleeve to lock the trap in position Regulator Sleeve Safety Trap DISS fitting 1 Insert the trap into the regulator fitting Situate the tubing in the desired position 2 Turn the DISS wi
13. apter 3 14 O ring 3 15 Bellows 16 Nut Elastic Stop 6 32 4 17 O ring 2 010 Buna N 2 18 Surgical Free Flow Base 19 Bottom Connector 20 Screw Flat Head 6 32 X 1 2 2 21 Selector Switch Assembly 22 Washer Flat 23 Screw Buttonhead Cap 8 32 X 5 16 24 Inlet Connector Universal 25 Screw Round Head 6 32 X 7 8 2 26 Filter 27 Screw No 6 Pan Head 4 28 Valve Tube 29 Regulating Bar 30 Screw Buttonhead Cap 8 32 X 3 8 4 31 Rear Window 33 32 Tubular Speed Clip 33 Locking Knob CONOR WN 16 6700 0088 000 Rev 6 7 Service Disassembly and Assembly 1 Remove the four screws located at the corners of the back cover Hold the regulator with the front cover and knob facing upward Rotate the suction control knob clockwise until the cover knob assembly is free of the rest of the regulator 2 Unscrew the cap screw from the suction control knob on the front cover Pull the suction control knob off 3 Carefully pull the gauge assembly out of its mount on the base The snap fit lens can also be removed If applicable Pull down plastic tab with right index finger whuile holding gauge frame with left hand Snap Fit Lens Removal 4 Remove the two small tubes which are connected from the bellows to the base 5 Use the locking wrench to remove the two screws holding the rear window in place Remove the window 6 Locate the regulating bar inside the recessed
14. b 3 Vacuum Gauge Displays the suction level to the patient during use Adapter Port Wrench Fitting Port Front and Side View 6700 0088 000 Rev 6 7 3 Descriptions and Specifications 3 2 Specifications Gauge Flow Rate Regulated Suction Ranges Standard Model High Models Weight Less Fittings Dimensions Less Fittings Latex Tubing 0 25 in 6 4 mm ID X 12 in 30 cm supplied Disposable tubing Available separately in some markets 6 mm ID X 450 mm 750 mm and 2 m to connect regulator and collection bottle Disposable Suction Filter Environmental Specifications Operating Temperature Range Storage Temperature Range Operating and Storage Relative Humidity Accuracy 5 of full scale deflection O to 150 LPM without fittings at full increase setting depending on supply vacuum and open air flow 0 to 200 mmHg 0 to 26 7 kPa 0 to 760 mmHg 0 to 101 3 kPa 22 oz 624 g Height 7 in 178 mm Width 3 5 in 89 mm Depth 4 6 in 117 mm 0 to full vacuum Flow dependent on source and setup O to full vacuum Flow dependent on source and setup 0 to full vacuum 0 to 100 LPM 650 mmHg 86 7 kPa 40 to 120 F 4 to 49 C 0 to 160 F 18 to 71 C 5 to 95 6700 0088 000 Rev 6 4 1 Equipment Set up WARNINGS A Connection to positive pressure sources such as oxygen and medical air even momentarily could injure the patient or operator A Al
15. bleshooting cccccessssenesseeeeesesenssnnenees 14 Table of Contents 7 Service Disassembly and Assembly 15 7 1 Service Tools and Equipment 0 15 J2 IDISASSOIMDIY digress deters Goseateieieecctades 15 7 3 NS SITY cs tarts da nast iced eaeecananatotalshdaterateiomdtend 18 8 Service Checkout Procedure scseecessseeeeees 19 S ES D o eee ee ee eee eee 20 8 2 Flow TOSt ceeceeccceeceeeeeeeeeeeeeeeeeeeeeeseeeeeeeeees 20 8 3 Gauge TeSierinrsrein 20 8 3 1 High Vacuum Gauges ONLY 20 8 3 2 Standard Vacuum Gauges ONLY 20 8 4 Regulation TeSiiacccc sce eee 20 8 5 Bleed Test srrccuncesscecdtecntimesstenciiimaniemaanienes 20 8 6 Leak Test resorin 21 Q MAiNteOMANCe ecccecceeeeeeeeeeeeneeeneeeneeeneeensenseeneeens 22 9 1 General Maintenance of Suction CUMIN atest sccseccneecs eae cortieerhereeieseere seach 22 9 2 Recommended Maintenance Schedule 22 9 2 1 Maintenance Schedule e 22 9 3 Repair Policy cesesence tA cesetiaeneieccnandesternnasteranas 23 9 4 Technical Assistance cceceeeeeeeeeeeeeeeeeees 23 9 5 Return Instructions 2 22 ccceceeeeseeeeeeees 23 9 6 Disposal Instructions ssssisctisseccectesvsieteenisinncere 23 10 Ordering Information ccccsssseeeeeseseeeeeees 24 10 1 Illustrated Parts ccccccccecccececeeeeeeeeeeeeees 24 10 2 Sefvice Kit sissors siirinsesi 25 Appendix Installation procedure fo
16. ce 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 0500 F 1 847 855 6218 OxygenCare Ltd EC REP 2 Holfeld Business Park Kilmacanogue Co Wicklow Ireland Tel 353 1 2769700 Fax 353 1 2764970 2013 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 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 and Freon are registered trademarks of E I du Pont de Nemours and Company Cavicide is a registered trademark of Metrex Research Corporation 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 6700 0088 000 Rev 6 04 2013
17. ee AR amp 6700 0088 000 Rev 6 11 4 Operation 4 5 Patient Set up 6 Turn the mode selector switch to On 1 Make sure the pre use checkout procedure Section 4 4 Pre Use Checkout Procedure has been performed 2 Clamp the connective tubing and set the mode selector switch to On 3 Set the prescribed suction level a AN WARNING es A The regulator MUST be occluded when setting the prescribed suction level so that f1 the patient does not receive higher than required suction 7 oA Xk Clamp woo y Zi 4 Turn the mode selector switch to O Off 5 Attach tubing to the vacuum port of the collection container Patient Connective Tubing recy 7 12 6700 0088 000 Rev 6 5 Cleaning Disinfection and
18. enheit DISS Diameter Index Safety System Consult Instructions for Use 2 6700 0088 000 Rev 6 1 Preca tiohS wi cicsrenissadesscprssncsstecesieisventerenesiecs science 4 A IDQUAIOMNS snn 4 1 2 Warnings scoicecectaxsotesnctsacusiniawiecutonnsetzeicinaies 4 did Cautions coxcoscncticaninptecanbeansatereicostougedsconnaans 5 1 4 Intended USO 0 cccccccccescenseeeesessseeseecreseessacsctnes 5 DIS COD E E E 6 2 1 North American Surgical Free Flow Vacuum Regulators seeen 6 2 2 International Surgical Free Flow Vacuum R gulatOr caestatcaen cecsagesgsetecoaccettaceasuseceatenccancdat 6 3 Description and Specifications sseseceee 7 Sel De scripti N seaca 7 3 2 OPEC CA N Seient nan 8 A Operatlon ussiciescsseneentecenctecceeeieeeenee 9 4 1 Equipment Set up ccc eeeeceeeeeeneeeeeees 9 4 1 1 Attaching the Overflow Safety Trap 10 4 2 Mode Selection cccceecccseeeeeseeeeeeeeeneeeees 10 4 3 Setting the Suction Level cccccceeeeee 10 4 4 Pre use Checkout Procedure ccee 11 4 5 Patient SQUID ost oicndcsnGenteiwdeceteeiesteennentie 12 5 Cleaning and Sterilization cccsssseesseeeeeees 13 5 1 Cleaning cdisa2certetasnctessontanediatelenentedceadeationded 13 5 1 1 Routine Exterior Cleaning 20 13 5 1 1 1 Approved Cleaning Solutions 13 5 1 2 Internal Component Cleaning 13 5 2 SlSrilZAtiOn acc ccaseincrccsserisnsacleteatioeen ein 13 6 Trou
19. es 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 400 mmHg 13 3 40 0 and 53 3 kPa 8 3 2 Standard Vacuum Gauge ONLY 1 Connect the regulator s fitting port to the low calibration gauge with tubing Set the mode selector switch to On Ensure that the gauge is in agreement with the low vacuum calibration gauge within the 10 mmHg 1 3 kPa tolerance Recommended test points are 40 80 and 140 mmHg 5 3 10 7 and 18 7 kPa 8 4 Regulation Test i Disconnect the calibration gauge and occlude the fitting port Depending on the type of regulator perform one of the following a If using a high vacuum regulator North American or International set the gauge to 300 mmHg 40 0 kPa b If using a standard vacuum regulator North American set the gauge to 100 mmHg 13 3 kPa 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
20. gauge 225 mmHg 30 0 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 Bubble leak tester Hexagonal allen wrench 3 32 in Phillips head screwdriver No 2 Flat head screwdriver 1 4 in Open end wrench 5 16 in Tweezers filter remover Wooden toothpick O ring remover Dow Corning 111 grease Ohio Medical P N 6700 0074 200 Tubing clamp Bottle brush 7 2 Disassembly WARNING 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 the patient A Clean and sterilize all suction equipment if contaminated before disassembly to ensure service personnel are not exposed to hazardous contamination 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 0088 000 Rev 6 15 7 Service Disassembly and Assembly Item amp Description Screw Socket Head Cap 4 40 x 1 2 Locking Cam Washer Flat 28 OD 125 ID Spring Washer Increase Label Control Knob Regulator Cover Control Shaft Snap Fit Lens 10 O rings 2 Gauge 11 Gauge Assembly Includes gauge O rings and lens 12 Tubing 125 OD 2 13 Ad
21. gt 14 O ring 3 oe ceeeeeceeeeeesteeessesteeeeeees 0210 0593 300 15 Bellows Assembly Includes bellows adapters and O rings 005 6700 0165 700 16 Nut Elastic Stop 6 32 4 6700 0175 400 17 O ring 2 Sacccwccincceaseeicnastsdetcartennse 6700 0131 500 18 Base Assembly Includes base adapter and serial number label North American ccccccceeeee 6700 0161 700 International ccccccceeseees 6700 0162 700 19 Bottom Connector 0206 5195 300 20 Screw Flat Head 6 32 X 1 2 2 6700 0171 400 6700 0088 000 Rev 6 10 Ordering Information Item amp Description 21 22 23 24 25 26 27 28 29 30 31 32 33 Washer Flat Selector Switch Assembly North American International Screw Buttonhead Cap 8 32 X 5 10 Inlet Connector Universal Screw Round Head Screw No 6 Pan Head 4 Valve Tube Regulating Bar Screw Buttonhead Cap 8 32 X 3 8 4 Rear Window Tubular Speed Clip eeeee Locking Knob Part Number 6700 0067 700 6700 0067 701 6700 0164 400 6700 0165 400 0206 5149 300 6700 0176 400 0206 5181 300 6700 0151 400 0206 5182 300 0206 5183 300 6700 0172 400 0206 5180 300 0206 5163 300 0212 1932 300 6700 0088 000 Rev 6 10 2 Service Kit Selector Switch Assembly Replacement Kit 6700 0013 200 Kit includes Buttonhead Screw 8 32 Flat Washer Selector Swi
22. iduals trained in the repair of this equipment should attempt to service it 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 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 To help prevent aspirate from entering the regulator wall outlet and pipeline equipment a safety trap and suction filter should be attached prior to its use Aspirate in the regulator wall outlet and pipeline equipment may impair its operation The use of the safety trap and suction filter will help prevent this and extend the life of the suction equipment To prevent stripping the plastic threads place the screw in the hole and turn counter clockwise until it drops into the original threads then tighten the screw Use of lubricants other than recommended may degrade plastic or rubber components Section 7 1 Servcice Tools and Equipment 1 Precautions 1 4 Intended Use The Ohio Medical Corporation Surgical Free Flow Vacuum Regulator is a vacuum powered body fluid suction apparatus that is intended to collect and remove body fluids in High Pressure High Flow applications generally in surgical procedures to aspirate fluid and debris from surgical fields 6700 0088 000 Rev 6 5 2 Scope This service manual contains service mai
23. ions NEVER use the Surgical Free Flow Vacuum Regulator for low flow applications Improper vacuum levels can cause a variety of injuries To help reduce the risk of injury appropriate suction applications MUST be used A When using the Surgical Free Flow Device direct contact with blood vessels and or vital organs should be avoided Direct exposure of high vacuum levels to tissue may result in serious injury A The Surgical Free Flow Device should never be used for low flow vacuum applications including endotracheal suctioning nasogastric suctioning and Chest Tube suction 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 Should such repair or replacement become necessary see the Ohio Medical service manual for service or repairs to this product For service advice Ohio Medical recommends that a telephone request be made to the nearest Ohio Medical Regional Service Center This product and any of its parts should only be repaired using written instructions provided by Ohio Medical or by Ohio Medical trained personnel The Product must not be altered without the prior written approval of Ohio Medical s Quality
24. kPa for the high vacuum gauge or 10 mmHg 1 3 kPa for the standard vacuum gauge 8 5 Bleed Test mk Occlude the fitting port and set the vacuum level to 100 mmHg 13 3 kPa Set 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 20 6700 0088 000 Rev 6 8 Service Checkout Procedure 8 6 Leak Test 1 Set the mode selector switch to O Off 2 Connect the regulator fitting port to the bubble leak tester port A with tubing 3 Rotate the suction control knob 1 2 turn in the clockwise increase direction 4 Observe the bubble leak tester No bubbles should appear 5 Rotate the suction control knob fully in the counter clockwise decrease direction 6 Set the mode selector switch to On 7 Observe the bubble leak tester No bubbles should appear Mode Selector Switch 00 Port B Vacuum Regulator Suction Control Knob Sealed 1 4 ID Clear Tubing with Knife Edge Bubble Leak Tester Bubble Leak Test Set up 6700 0088 000 Rev 6 21 9 Maintenance 9 1 General Maintenance of Suction Equipment WARNINGS A The pre use checkout procedure Section 4 4 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
25. le explosion hazard exists in the presents of these agents After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy Clean and disinfect all suction equipment before shipment for service to ensure transportation personnel and or service personnel are not exposed to any hazardous contamination Clean anddisinfect all suction equipmentifcontaminated 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 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 4 6700 0088 000 Rev 6 1 3 Cautions Cleaning the gauge may cause damage which will result in inaccurate readings DO NOT steam autoclave or liquid sterilize the Surgical Free Flow Vacuum Regulator Severe impairment to the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide 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 Only competent indiv
26. nd slide the suction control knob onto the shaft Place the curved spring washer and flat washer in the center hole of the knob Start the cap screw in the hole Run the screw all the way in until the knob is locked in position The locking cam should be in place on the screw head so that it seats against the tab in the control knob from a clockwise direction Loosen the cap screw one turn counter clockwise until the cam hits the tab on the control knob If the suction control knob does not turn freely loosen the cap screw Hold the base assembly with the bellows and gauge facing upward Place the cover over the base and engage the control shaft with the bellows by turning the suction control knob counter clockwise Install the four cover screws To prevent stripping the plastic threads place the screw in its hole and turn counter clockwise until it drops into its original threads then tighten the screw Perform the service checkout procedure Secton 8 Service Checkout Procedure before returning the regulator to service 6700 0088 000 Rev 6 8 Service Checkout Procedure WARNING A 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 Important This entire service checkout procedure must be performed in numerical order Mode Selector Switch Supply Vacuum Gauge 0 to 760 mmHg 0 to 101 3
27. ng nut clockwise to engage the threads and tighten there is no O ring so the vacuum seal depends on a tight ae Regulator F Wing Nut i Safety Trap j 4 2 Mode Selection On Suction can be adjusted with the suction control knob On aA X O Off No suction is supplied to the patient _ 0 Off A 4 3 Setting the Suction Level WARNING A The regulator MUST be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction 1 Clamp the connective tubing to occlude the fitting port 2 Turn the mode selector switch to On 3 Rotate the suction control knob until the vacuum gauge indicates the required setting 10 6700 0088 000 Rev 6 4 Operation 7 With the tubing still clamped increase the suction 4 4 Pre use Checkout Procedure to 300 mmHg 40 0 kPa For the standard model WARNING increase the suction to 100 mmHg 13 3 kPal A The pre use checkout procedure MUST be 8 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 Slowly open and close the
28. ntenance and parts information on five models of the Surgical Free Flow Vacuum Regulator 2 1 North American Surgical Free 2 2 International Surgical Free Flow Vacuum Regulators Flow Vacuum Regulator Note Part numbers given are for vacuum regulators Note Part numbers given are for vacuum regulators without fittings or adapters without fittings or adapters High 6700 1248 900 Counter clockwise High 0 to 760 mmHg 6700 1247 900 0 to 101 3 kPa Clockwise 0 to 700 mmHg Standard 6700 1246 900 Clockwise 0 to 200 mmHg 6 6700 0088 000 Rev 6 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 presents of these agents The Surgical Free Flow Vacuum Regulator is designed for applications in high use areas where high flow rates and minimal maintenance requirements are of significant benefit Flow rates of up to 150 LPM are made possible by the use of a large bore unobstructed passage through the regulator In place of the conventional diaphragm valve assembly the regulator uses a unique device called a regulating bar to control suction During use as the flow requirement increases the
29. ould misuse occur resulting in accidental flooding of the regulator the regulator may be sterilized using ethylene oxide ETO After sterilization follow the instructions in Section 8 Service Checkout Procedure 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 CAUTION A Do not steam autoclave or liquid sterilize the 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 contaminated or maintenance is to be performed 1 The regulator should be sterilized with the mode selector switch in the On position 2 The only acceptable method of sterilization is with ethylene oxide Ethylene oxide mixtures can be used at temperatures of 125 to 1385 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 filte
30. r The filter is located just above the fitting port at the rear of the regulator If the filter appears to have shrunk replace it before placing the regulator back in service Place the regulator in the vertical position and connect to a supply vacuum of 450 mmHg 60 0 kPa 6700 0088 000 Rev 6 13 6 Troubleshooting Problem __ Possible Causes No gauge indication and No supply vacuum no suction in any setting No gauge indication but suction is being delivered Gauge indication but no suction is being delivered Suction level cannot be adjusted 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 With the fitting port occluded unable to decrease the suction level and gauge needle does not return to zero when switched to O Off Mode selector switch sticks in O Off or On position Insufficient flow through regulator Inaccurate gauge reading Poor connection Blocked adapter port Blocked backplate Blocked adapter Blocked gauge pressure sensing orifice Gauge mechanism locked by debris Gauge mechanism damaged Tubing connected to bellows is blocked or disconnected Blocked fitting port Overflow safety trap shut off Blocked external filter Blocked fitting Gauge mechasim locked by debris Loose regulating bar Tubing connected to bellow
31. r Adapters Probes andi FIMNOS aiersism i A 1 6700 0088 000 Rev 6 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 ACAUTION Indicates a potentially hazardous situation which if not avoided could result in damage to the device or other property A WARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury A Attention Alerts you to a warning or caution in the text 1 2 Warnings The pre use checkout procedure Section 4 4 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 ALWAYS connect the regulator to the vacuum source and check its operation BEFORE attaching the patient connection 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 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 possib
32. s is blocked or disconnected Damaged or loose valve tube Damaged gauge Blocked filter and or orifice Damaged gauge Dry or damaged O rings Contaminated passage ways Partial blockage in wall supply Partial blockage in regulator 6700 0088 000 Rev 6 Correct supply problem Check all connections and seals Unblock port Clean with soap and water and a bottle brush Unblock replace Unblock orifice Remove debris Replace gauge Unblock or reconnect tubing Unblock port Reset float and or empty overflow safety trap Replace external filter Replace fitting Remove debris Tighten regulating bar Unblock or reconnect tubing Replace or reconnect valve tube Replace gauge Clear orifice and replace filter Replace gauge Lubricate or replace and lubricate O rings Remove and clean mode selector switch assembly Confirm wall supply open air flow meets minimum hospital requirements Unblock if necessary Perform the flow test in the service checkout procedure section of this manual Section 8 2 Flow Test Clear blockage if necessary 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 450 mmHg 60 0 kPa minimum and 80 LPM open air flow minimum Low vacuum calibration
33. tch Assembly 25 Appendix 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 properly 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 A 1 CAUTION A 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 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 6700 0088 000 Rev 6 Notes 6700 0088 000 Rev 6 i nio Medical Corporation always there for life North America United States Customer Servi
34. ways connect the regulator to the vacuum source and check its operation before attaching the patient connection CAUTIONS A Connection to positive pressure sources such as oxygen and medical air even momentarily could damage the equipment If the regulator is equipped with an adapter for wall outlets insert the adapter into the vacuum wall outlet If the regulator is mounted elsewhere connect a vacuum supply hose between the regulator s adapter port and the wall outlet Connect the collection bottle s vacuum port to the regulator s fitting or overflow safety trap with the appropriate vacuum tubing Note For proper installation of adapters probes and fittings see Appendix A 1 4 Operation Use hospital supplied suction tubing between the vacuum regulator and the collection container as well as between the patient port of the collection container and the patient minimum inside diameter is 0 25 in 6 mm An Ohio Medical high flow suction filter and or overflow safety trap should be used between the collection container and regulator to prevent contamination of the regulator wall outlet and pipeline equipment ISO 10079 3 Section 5 1 2 states that the usable volume of the collection container shall be not less than 500 mL 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 0
Download Pdf Manuals
Related Search