6700 -0011 000 thoracic service manual revd.qxp - BOC e
Contents
1. 5 Reduce the suction level to zero and turn the mode selector switch to OFF O Thoracic 4 3 6700 0011 000 RevD 09 2007 Operation 4 4 2 4 Patient Set up 1 3 Make sure the Pre Use Check out Procedure has been performed Turn the mode selector switch to ON I and clamp the connective tubing Set the prescribed suction level A WARNING The patient port of the regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction levels 4 Important Add the 2cm water seal amount to the level set on the regulator gauge to determine the total suction level Turn the mode selector switch to OFF O ANWARNING A water seal must be used with the Thoracic vacuum regulator to prevent air from enter ing the pleural cavity and to indicate the presence of air leaks in the lungs and or the collection system 5 6 Fill the water seal to its designated level Connect the regulator to a reusable water seal illus trated or a disposable system with a water seal Connect the water seal to the collection bottle s vac uum port Attach the patient tubing to the collection bottle s patient port 6700 0011 000 RevD NI 09 2007 4 4 4 Operation Patient Set up continued 9 Turn the mode selector switch to ON I 12. 3 Check all connections and seals 4 Clean port 5 Clean or replace probe adapter 6 Clean outlet 1 Clean orifice and or gauge tubing 2 Gently blow out dust 3 Replace gauge 1 Clean port 2 Replace external filter 3 Clean or replace fitting 1 Replace diaphragm 2 Replace control shaft 3 Free up piston 1a Confirm wall supply open air flow meets minimum hospital requirements 1b Clean if necessary 2a Perform the Flow Test in the Service Check out Procedure Section of this manual 2b Clear blockage if necessary Problem F Inaccurate gauge reading Note All gauge needles should come to rest at the stop pin when no suction is being supplied G No suction in any setting and whistling or vibrating noise from inside the regulator Possible Causes 1 Damaged gauge 1 Vacuum relief valve failure 2 Positive pressure safety relief valve failure 6700 0011 000 RevD 09 2007 Troubleshooting 6 Remedy 1 Replace gauge 1 Replace rubber sleeve and ensure that the steel ball is present and clean 2 Replace positive pressure safety relief valve 7 Service Disassembly and Assembly 7 1 Service Tools and Equipment A CAUTION Use of lubricants other than recommend ed may degrade plastic or rubber components The following items should be on hand during any serv ice procedure e Supply vacuum 300 mmHg 40 kPa minimum with 60 lpm open air flow minimum Bubble leak tester
3. 50 Ipm flowmeter 6700 0355 800 Water manometer or calibrated vacuum gauge 0 to 70 cmH20 1 cm H20 Water manometer or calibrated pressure gauge 0 to 70 cm H20 1 cm H20 Dow Corning No 111 lubricant 6700 0074 200 e Pliers Loctite 242 removable thread locker 6600 0058 300 1 4 inch flathead screwdriver e No 2 Phillips screwdriver Internal snap ring pliers e 5 16 and 9 16 open end wrenches Positive pressure source delivering 10 lpm open flow Toothpick O ring removal 7 2 Disassembly A WARNING If the vacuum regulator is repaired or disassembled in any manner the Service Check out Procedure must be performed before using the equipment on a patient A WARNING After patient use regulators may be contaminated Handle in accordance with your hos pital s infection control policy A WARNING Clean and sterilize all suction equip ment before shipment to ensure transportation per sonnel are not exposed to any hazardous contamina tion A CAUTION The gauge assembly must be handled with utmost care to retain its precision If the lens is removed do not rest the gauge on its face 1 Remove the four cover mounting screws and lift off the front cover 2 Pull the knob off of the control shaft as well as the washer and plastic spacer on the shaft under the knob 3 Gently slide the gauge out of its mounting and dis connect from tubing Note The plastic gauge lens should remain att
4. probes 2 1 North American 2 2 International Thoracic Vacuum Regulator Thoracic Vacuum Regulator 6700 1275 901 6700 1276 901 2 4 6700 0011 000 RevD 09 2007 Scope 2 2 3 French 2 4 Spanish Thoracic Vacuum Regulator Thoracic Vacuum Regulator 4 igh F C 3 low cuum o 1 n 6700 1277 901 6700 1278 901 6700 0011 000 RevD 09 2007 2 2 3 Description and Specifications 3 1 Description A WARNING Do not use this device in the presence of flammable anesthetics Static charges may not dissipate and a possible explosion hazard exists in the presence of these agents The Thoracic Vacuum Regulator is a lightweight com pact unit used throughout the hospital for chest and mediastinal drainage Each regulator contains a vacuum gauge which indicates suction supplied by the regulator The Thoracic Vacuum Regulator operates only in a reg ulated vacuum mode The unit has a diaphragm type reg ulator which provides an adjustable vacuum of 0 to 50 cm H2O O to 4 9 kPa The regulator has a vacuum gauge with increments to 60 cm H2O and 6 kPa and is housed in impact resistant plastic for durability A vacuum limiting valve is incorporated which limits the maximum vacuum to a value between 50 and 60 cm H20 4 9 and 5 9 kPa If positive pressure is applied to the patient port e
5. 3030 300 9 Screw eee eee 6700 0208 400 7 3 6700 0011 000 RevD 09 2007 Service Disassembly and Assembly 7 Vacuum Relief Adjustment Kit Includes items 1 and 2 6700 0432 850 1 Vacuum Relief Adjustment Screw 2 Vacuum Relief Body 2 Ball 2r eium de embed a 0409 1686 300 4 Patient port fitting 0204 9046 535 D Org sxisbbisue xe LETS EG 6700 0130 500 6 Diaphragm szeri aea eee 0210 7300 100 42 BISCU c inm poa erit x E oes aad 0214 3212 300 8 Backplate lusuus 0212 0810 100 9 Rubber Sleeve 0211 0719 500 10 Screws 4 002000000 0140 6124 112 6700 0011 000 RevD 09 2007 7 4 7 Service Disassembly and Assembly 1 Snapring 2 0 05 0203 5213 300 2 ONG sees 0210 0629 300 3 O ing sortat d a eee 6700 0132 500 4 Brass nut 0 cee eee 0402 1659 500 bL Sptrlhg ia oe auti ty ena ee 0203 3054 300 6 Spring Button 0212 0800 100 7 Spring Case Cover 0221 6365 300 98 O ring LAE EAM Oe ct sd 6700 0100 400 9 Baffle Guide Plate 0212 0804 100 10 Piston cane oer e 6700 0099 400 11 O ring e ra daa a a 0210 0527 300 12 Flapper Valve 0211 1451 100 13 Control Shaft 0221 6351 500 7 3 Assembly Reassembly is the reverse of disassembly Before reassembling the unit sparingly lubricate all of the O rings with Dow Corning No 111 A CAUTION To
6. Component Cleaning 5 1 5 2 Sterilization dete ehe gei seb a an ies 5 1 6 Troubleshooting sees 6 1 7 Service Disassembly and Assembly 7 1 7 1 Service Tools and Equipment 7 1 7 2 Disassembly riede eee EE RANEE 7 1 7 3 Assembly erranei EEren eee 7 5 8 Service Check Out Procedure 8 1 9 1 SOLU m Adesso er ELI EV 8 1 8 2 Flow Test 200 000 e eee ee eee 8 1 8 3 Gauge Test 2 0 00 e eee eee 8 2 8 4 Regulation Test 0 eee eae 8 2 8 5 Vacuum Limit Test 2000 00a 8 2 8 6 Positive Pressure Relief Test 8 3 8 7 Leak Test xis ERES IRR 8 3 9 Maintenance leeeeeeeeeennee 9 1 9 1 General Maintenance of Suction Equipment 9 1 9 2 Recommended Maintenance Schedule 9 2 9 2 1 Maintenance Schedule 9 2 9 3 Repair Policy 0 0 c eee eee 9 2 9 4 Technical Assistance 0 000 9 3 9 5 Return Instructions 2 205 9 3 10 Ordering Information 10 1 10 1 Service Parts 0 0 0 0 c cee eee 10 1 10 2 Adapters Probes 0000 10 1 10 3 International Regulator Options 10 1 10 4 North American Regulator Options 10 2 Appendix leen A 1 6700 0011 000 RevD 09 2007 This product will perform in conformity with the descrip tion thereof contained in this manual and accompanying
7. If the vacuum regulator is repaired or disassembled in any manner the Service Check out Procedure must be performed before using the equipment on a patient The Pre Use Check out Procedure must be performed before using this equipment on each patient If the regu lator fails any part of the Pre Use Check out Procedure it must be removed from service and repaired by quali fied service personnel Loctite is a registered trademark of the Loctite Corporation 09 2007 Precautions 1 1 3 Cautions Cleaning the gauge may result in damage Do not steam autoclave or liquid sterilize the regulator Severe impairment of the operation of the regulator will result The only acceptable method of sterilization is with gas ethylene oxide To help prevent aspirate from entering the regulator the Thoracic Vacuum Regulator should always be used as part of a water seal drainage system If as a result of mis use water or aspirate gets into the regulator it may impair the regulator s operation Do not use any Loctite products or products which con tain Methacrylate Ester as an active ingredient to seal the probe adapter port threads Only competent individuals 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 Prior to
8. Loctite amp may seal the steel ball to the seat This will disable the vacuum relief valve and may allow suc tion to exceed the pre set limit The vacuum relief valve must be tested to assure com pliance with the manufacturer s specifications before the 1 1 6700 0011 000 RevD unit is placed in service Remove the unit from service if it fails the test Otherwise excessive suction can cause injury to a patient With the patient tubing occluded all bubbling in the water seal should stop so it will indicate air leaks in the lungs If bubbling does not stop check all connections to elimi nate leaks When a leak free collection system connected to a patient is turned on after initial air in the system is elimi nated only patient air will produce bubbles in the water seal 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 connec tion Do not use this device in the presence of flammable anesthetics Static charges may not dissipate and a pos sible explosion hazard exists in the presence of these agents Following sterilization with ethylene oxide quarantine parts in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material Aerate for 8 hours at 130 F 54 C
9. Ltd Corrig Road Sandyford Industrial Est Dublin 8 Ireland Phone 35 31 295 3421 North America United States Customer Service and Distribution Center Technical Support Sales and Service Equipment Service Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee Il 60031 4099 USA Toll free 866 549 6446 Phone 1 847 855 0800 Fax 41 847 855 6218 www ohiomedical com 6700 0011 000 RevD 09 2007
10. g patient coughing a positive pres sure relief valve operates to quickly relieve the pressure Mode Selector Switch Vacuum Gauge Suction Control Knob 3 1 6700 0011 000 RevD In the On mode the vacuum source is connected through the regulator module which functions as an auto matic valve Turning the suction control knob adjusts the position of the regulator module and allows selection of a predetermined level of suction During use as the flow requirement increases the valve automatically opens to maintain suction at the pre set level Conversely when the flow requirement decreases the valve automatically closes to maintain suction at the pre set level The same mechanism compensates for changes in supply vacuum and automatically maintains the pre set suction level 1 Suction Control Knob Allows easy adjustment of suction to the patient 2 Mode Selector Switch Allows quick and easy selec tion of On Off I O a Onll Suction can be adjusted with the suction control knob b OFF O No suction is supplied to the patient 3 Vacuum Gauge The suction level to the patient is displayed during use Probe Adapter Port Patient Port 09 2007 3 2 Specifications 3 2 1 Technical Specifications Gauge Flow Rate Positive Pressure Safety Relief Valve Regulated Suction Range Vacuum Relief Valve Weight less fittings Dimensions less fittings Latex tub
11. or use Aerate parts prior to reassembly A WARNING Following sterilization with ethylene oxide quarantine parts in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material Aerate for 8 hours at 130 F 54 C A CAUTION Prior to placing the unit back into service after disassembly or cleaning perform the Service Check out Procedure 09 2007 5 1 6 Troubleshooting Place the regulator in the vertical position and connect to a supply vacuum of at least 300 mmHg 40kPa and open air flow of 60 lpm Problem A No gauge indication and no suction in any setting B No gauge indication but suction is being delivered C Gauge indication but no suction is being delivered D Suction level cannot be adjusted E Insufficient flow through regulator 6 1 Possible Causes 1 2 3 No supply vacuum Kinked suction tube Poor connection Blocked probe adapter port Blocked probe adapter Blocked wall outlet Blocked gauge pres sure sensing orifice and or gauge tubing Dust in gauge mechanism Gauge mechanism damaged Blocked patient port Blocked external filter Blocked fitting Regulator diaphragm rupture Broken or stripped control shaft Piston stuck in baffle guide plate Partial blockage in wall outlet Partial blockage in regulator 6700 0011 000 RevD 09 2007 Remedy 1 Correct supply problems 2 Straighten tube
12. sure that the calibra tion gauge has an accuracy of 1 cmH20O 0 1 kPa or better 1 Connect the regulator s patient port to the calibration gauge with tubing 2 Turn the mode selector switch to On l 3 Check that the regulator gauge is in agreement with the vacuum calibration gauge within the 3 cmH2O 0 3 kPa tolerance Recommended test points are 15 30 and 45 cmH20 1 5 3 and 4 4 kPa 8 4 Regulation Test 1 Disconnect the calibration gauge and occlude the patient port 2 Setthe vacuum level on the gauge to 30 cmH20 3 0 kPa 3 Open and close the patient port several times 4 With the patient port occluded the regulator gauge should return to the setting listed in step 2 within a tolerance of 3 cmH2O 0 3 kPa Steel Ball 8 2 6700 0011 000 RevD 8 5 Vacuum Limit Test Occlude the patient port of the regulator Turn the suction control knob fully counter clockwise full decrease Slowly increase the vacuum and observe the gauge The vacuum relief valve should start opening between 50 and 60 cmH20 4 9 and 5 9 kPa The gauge needle may oscillate but the vacuum should not increase beyond 65cmH20 6 4 kPa as the suc tion control knob is turned further clockwise 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 rot
13. 0 Clamp the patient tubing 11 After a brief period all bubbling in the water seal should stop ANWARNING With the patient tubing occluded all bubbling in the water seal should stop so it will indi cate air leaks in the lungs If bubbling does not stop check all connections to eliminate leaks 12 Release the clamp on the patient tubing A WARNING When a leak free collection system connected to a patient is turned on after initial air in the system is eliminated only patient air will produce bubbles in the water seal Release Clamp 4 5 6700 0011 000 RevD 09 2007 Cleaning and Sterilization 5 5 1 Cleaning A WARNING After patient use regulators may be contaminated Handle in accordance with your hos pital s infection control policy 5 1 1 Routine Exterior Cleaning Routine cleaning of the regulator is recommended as standard procedure after each use Wipe the exterior surfaces with a solution of water and mild detergent 5 1 2 Internal Component Cleaning The regulator requires cleaning if it becomes flooded with patient fluid as a result of misuse 1 Refer to the Service Disassembly and Assembly instructions Handle in accordance with your hospi tal s infection control policy 2 Allinternal components with exception of the gauge may be cleaned with a solution of warm water and mild detergent A CAUTION Cleaning the gauge may result i
14. 0300 802 T 2 NCG Adapter round 6700 0505 802 3 NCG Adapter rectangle 6700 0500 802 hl 3 Schrader Adapter 0221 0690 731 pe 4 DISS Union Nut amp Gland 6700 0094 700 oF 5 DISS Hand I Twist Nut Gland 6700 0510 802 A 6 OES Adapter 0221 0152 300 7 Puritan Adapter 6700 0535 802 Ch 8 Medstar Adapter 0221 0163 300 nm 9 Dr ger Adapter 6700 0051 700 uc Ys zl 10 3 International Regulator Options Thor cico English French Spanish 6700 1276 901 6700 1277 901 6700 1278 901 6700 0011 000 RevD 09 2007 10 1 10 Ordering Information 10 4 North American Regulator Options Select the adapter to form an 11 digit part number Example 6701 1275 901 6701 Adapters 67XX od pe 4 D Diamond Adapter 6700 w 1 8 NPT Female 6701 Ohio Diamond 6702 DISS Hand l Twist HIT 6703 DISS Nut and Gland 6704 Schrader 6705 Chemetron Rectangle NCG 6706 Chemetron Round NCG 6707 Puritan Bennett 6708 O E S 6709 O E S MedStar 6714 DISS Male 1275 901 North American Tubing Thoracic Regulator Nipple Regulator 1275 Fitting 901 Basag amp l 6722 1275 901 North American 6700 1275 901 The following Ohio Medical rail options are also a
15. 60 mm Hg 0 to 101 3 kPa Vacuum LAN Supply Vacuum Regulator lt 300 mmHg 40 kPa Open Flow of 60 lpm Suction Control Knob J haz od AL Lr ma cv n nz Pedi Es EL assit s dd RN heel E Water Manometer or Calibrated Vacuum Gauge Flowmeter 70 cmH90 6 9 kPa 50 Ipm 8 1 Set Up 1 Verify that there is a minimum of 300 mmHg 40 kPa vacuum on the supply gauge 2 The supply open flow must be at least 60 Ipm 3 Connect the supply vacuum to the probe adapter port of the regulator 6700 0011 000 RevD gt lt Occluded Water Manometer or Calibrated Pressure Gauge 70 cmH20 6 9 kPa Pressure Source Open Flow 10 Ipm 8 2 Flow Test 1 Connect the regulator s patient port to the flowmeter with tubing Use the shortest tubing possible with an inside diameter of 0 25 in 6mm or larger 2 HRotate the suction control knob fully clockwise increase 3 Turn the mode selector switch to On l and verify that the flow rate is at least 40 Ipm 4 Turn the mode selector switch to Off O and discon nect the flowmeter 09 2007 8 1 8 Service Check Out Procedure 8 3 Gauge Test Note All Ohio Medical gauges are supplied with an accu racy of 5 of full scale deflection throughout their range Note All gauge needles should come to rest at the stop pin when no suction is being supplied Gauges which do not comply may be out of calibration When checking gauge accuracy be
16. Ohio Medical Corporation Thoracic Vacuum Regulators Service Manual 6700 0011 000 RevD 09 2007 Table of Contents User Responsibility esee i 1 PrecautionS eee eee 1 1 1 1 Definitions llli 1 1 1 2 Warnings 5 ceca E EEA LIQUET 1 1 1 9 Gautions ss baat oe RES eee E ed 1 2 2 SC0D8 l l eger e lI E A E N 2 1 2 1 North American Thoracic Vacuum Regulator 2 1 2 2 English Thoracic Vacuum Regulator 2 1 2 3 French Thoracic Vacuum Regulator 2 2 2 4 Spanish Thoracic Vacuum Regulator 2 2 3 Description and Specifications 3 1 3 1 Description e eee 3 1 3 2 Specifications 2 cece eee 3 2 3 2 1 Technical Specifications 3 2 3 2 2 Environmental Specifications 3 2 3 2 3 Standards 0 0 ea pe n ia 3 2 4 Operatlon 3 ce ru tme hl nse eee ee 4 1 4 1 Equipment Set up 00055 4 1 4 2 Operation 0 2 0 0 a eee 4 2 4 2 1 Mode Selection 0000000s 4 2 4 2 2 Setting the Suction Level 4 2 4 2 3 Pre Use Check out Procedure 4 2 4 2 4 Patient Set up 2 000 000 e ee 4 4 5 Cleaning and Sterilization 5 1 Hal Gleaning c ss er iere ars te edie mu n ee 5 1 5 1 1 Routine Exterior Cleaning 5 1 5 1 2 Internal
17. ached to the gauge 4 Remove the connecting tube with the restricting ori fice from the regulator assembly 5 Unhook the tension spring if present from the ON OFF selector switch A CAUTION Use care when unhooking the tension spring from the regulator Excessive tension on the spring can crack the plastic at the base of the mount ing post 6 Remove the mounting screw and spring washer from the center of the ON OFF switch Lift the switch from the unit and unplug its connecting line to the regula tor assembly Use a toothpick to remove the O ring from its recess in the back plate 7 Unbolt the probe adapter connector from the back plate Use a tooth pick to remove the O ring 8 Pull the vacuum relief valve off its mounting vent cup your hand under the valve to catch the ball as it falls out while unscrewing the adjustment screw 9 Remove the regulator assembly mounting screws and lift the assembly off the back plate 10 Take the diaphragm off the back plate Note The metal disc at the center of the diaphragm may be removed for further cleaning if necessary 11 Separate the regulator assembly and remove the large O ring seal 12 Unscrew the patient port fitting from the regulator assembly and remove the O ring 7 6700 0011 000 RevD 09 2007 Service Disassembly and Assembly 7 13 Using the snap ring pliers remove the snap ring that Note The spring button and piston should be left retains the contr
18. amount of water in the suction control chamber Note A positive pressure relief valve in the disposable collection system will prevent pressure buildup in the system if the system is clamped between the vacuum regulator and the collection device A CAUTION To help prevent aspirate from entering the regulator the Thoracic Vacuum Regulator should always be used as part of a water seal drainage sys tem If as a result of misuse water or aspirate gets into the regulator it may impair the regulator s oper ation Setup with Disposable Collection System For reference only Unit not supplied by Ohio Medical Thoracic Vacuum Regulator Patient Drainage Port Atmospheric un end Me nl T p LJ Disposable Chest Dralnage Unit C A 0 E aL Suction Control En EE E Chamber shown E HEIL wl with no water in s EH E Collection Water chamber IE HE E Chamber Seal E E E Bottle E II El E aE Drainage F EI ElI E Collection s Ir wf aF Bottle tll aE a i AN _ with Shut off Je El EJ 2 cm Water Seal Valve 4 1 6700 0011 000 RevD 2 cm Water Seal 09 2007 Operation 4 4 2 Operation 4 2 1 Mode Selection ff P N Y ON I Suction can be adjusted with the suction control knob OFF O No suction is supplied to the patient ff a J 4 2 2 Setting the Suction Level Turn the mode selector swi
19. ation will increase the suction level at which the relief valve opens Counterclock wise rotation will decrease the suction level at which the relief valve opens When the desired limit is reached lock the screw with a drop of removable thread locker Loctite amp 242 WARNING Excess Loctite amp may seal the steel ball to the seat This will disable the vacuum relief valve and may allow suction to exceed the pre set limit Repeat the steps one through four Valve Body e O ring c Loctite amp 242 Screw w Magnet 09 2007 8 6 Positive Pressure Relief Test 1 Set the mode selector switch to Off O 2 Connect the pressure source and calibrated pres sure gauge to the patient port of the regulator with tubing see diagram on page 8 1 3 Apply a positive pressure 10 lpm open flow and observe the calibrated pressure gauge 4 The pressure should not exceed 10 cmH20 1 0 kPa Mode Selector Switch Vacuum Regulator Service Check Out Procedure 8 8 7 Leak Test 1 Connectthe regulator patient port to the Bubble Leak Tester port A with tubing see diagram below 2 Setthe mode selector switch to Off O and check that the suction control knob is set approximately in the middle of its range 3 Observe the Bubble Leak Tester No bubbles should appear within 10 seconds 4 Rotate the suction control knob fully in the counter clockwise decrease direction and turn the mode select
20. bottles tubing metal connectors etc and removing all residue 2 Wipe all exterior surfaces with a solution of water and mild detergent 3 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 con nected securely to the correct ports 6 Checkthe floats in the Overflow Safety Trap and col lection bottle for correct operation 7 Perform the Pre Use Check out Procedure 09 2007 Maintenance 9 9 2 Recommended Maintenance Schedule In addition to the Pre Use Check out Procedure the following periodic maintenance should be performed 9 2 1 Maintenance Schedule Item Minimum Frequency Service Check out Every 4 months Elastometric Components Positive pressure safety relief flapper valve e Switch O ring e Low vacuum relief valve sleeve e Control shaft O rings Patient port O ring e Probe Adapter connector O ring High Flow Replace after each Disposable Suction Filter if flow deteriorates patient use 9 3 Repair Policy A WARNING Clean and sterilize all suction equip ment before shipment to ensure transportation per sonnel are not exposed to any hazardous contami nation A CAUTION Do not steam autoclave or liquid steril ize the regulator Severe impairment of the operation of the regulator will result The only acceptable method of sterilization is with gas et
21. cuum source only Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment A WARNING Always connect the regulator to the vacuum source and check its operation before attaching the patient connection Connect the collection system s vacuum port to the reg ulator s patient port with the appropriate vacuum tubing Hospital supplied suction tubing must be used between the vacuum regulator the water seal the collection bot tle and the catheter Recommended minimum inside diameter is 0 25 in 6mm ISO 10079 3 BS7259 Part 2 Section 5 1 2 states the usable volume of the collection container shall be not less than 500 ml Setup with Reusable Collection System Thoracic Vacuum Regulator Patient Drainage Port Note A positive pressure relief valve in the Thoracic vac uum regulator will prevent pressure buildup in the system if suction is turned off using the On Off I O switch A WARNING Clamping the tubing between the patient and the collection bottle may result in pres sure buildup in the catheter and tubing A WARNING When using a disposable system the atmospheric vent at the top of the suction control chamber must be occluded for proper suction regu lation with the Thoracic vacuum regulator Important Once the atmospheric vent is occluded the Thoracic vacuum regulator controls vacuum level regard less of the presence or
22. e provides additional information to clarify a point in the text Important An Important statement is similar to a note but of greater emphasis A CAUTION A CAUTION statement is used when the possibility of damage to the equipment exists A WARNING A WARNING statement is used when the possibility of injury to the patient or the operator exists aan y European Union Representative Stat 1 2 Warnings This device is to be used only by persons who have been adequately instructed in its use After patient use regulators may be contaminated Handle in accordance with your hospital s infection con trol policy Clean and sterilize all suction equipment before ship ment to ensure transportation personnel are not exposed to any hazardous contamination Clamping the tubing between the patient and the collec tion bottle may result in pressure buildup in the catheter and tubing When using a disposable system the atmospheric vent at the top of the suction control chamber must be occlud ed for proper suction regulation with the Thoracic regula tor The patient port of the regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction levels A water seal must be used with the Thoracic Regulator to prevent air from entering the pleural cavity and to indi cate the presence of air leaks in the lungs and or the col lection system Excess
23. hylene oxide 6700 0011 000 RevD Inspect every 4 months Replace every 24 months Comments If the regulator does not pass the Service Check out Procedure refer to the Troubleshooting section of this manual Repair as necessary Replace as necessary to minimize in use failures Replace more frequently ANCAUTION Only competent individuals trained in the repair of this equipment should attempt to serv ice it Do not use malfunctioning equipment Make all neces sary repairs Have the equipment repaired by qualified service personnel or by Ohio Medical Parts listed in this service manual may be repaired or replaced by a compe tent trained person who has experience in repairing devices of this nature After repair perform the Service Check out Procedure to ensure that the equipment is functioning properly and complies with the published specifications 09 2007 9 2 9 Maintenance 9 4 Technical Assistance If technical assistance is required contact Ohio Medical technical support or field operations listed on the back cover 9 5 1 2 9 3 Return Instructions Clean and sterilize the vacuum regulator Package the vacuum regulator securely for protec tion preferably in the original container Include a letter describing in detail any difficulties experienced with the vacuum regulator Include the person title and telephone number to contact for questions Ohio Medical now offers a ten year
24. ing 0 25 in 6 4 mm I D Disposable tubing available separately in some markets 6 mm I D x 450 mm 750 mm and 2m Disposable Suction Filter 3 2 2 Environmental Specifications Operating Temperature Range Storage Temperature Range Operating and Storage Relative Humidity 3 2 3 Standards Certified to ISO 10079 3 BS 7259 Part 2 Description and Specifications 3 Accuracy 3 cm H2O 0 3 kPa 0 to 40 Ipm without fittings at full increase setting depending on the supply vacuum and open air flow Located in patient circuit to prevent pressurization of patient chest cavity in excess of 10 cm H2O 1 0 kPa 0 to 50 cm H2O 0 to 4 9 kPa 50 to 60 cm H2O 4 9 to 5 9 kPa 24 oz 680 grams Height 7 2 in 185 mm Width 3 5 in 90 mm Depth 4 3 in 108 mm 0 to full vacuum Flow dependent on source and set up 0 to full vacuum Flow dependent on source and set up to connect regulator and collection bottle 0 to full vacuum 0 to 100 lpm 650 mm Hg 87 kPa 40 F 4 C to 120 F 49 C O F 18 C to 160 F 71 C 5 to 95 6700 0011 000 RevD 09 2007 3 2 4 Operation 4 1 Equipment Set up If the regulator is equipped with a probe adapter for wall outlets insert the probe adapter into the vacuum wall outlet If the regulator is mounted elsewhere connect a vacuum supply hose between the regulator s probe adapter port and the wall outlet A WARNING Connect the vacuum regulator to the va
25. labels and or inserts when assembled operated main tained 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 contami nated should be replaced immediately Should such repair or replacement become necessary Ohio Medical recommends that a telephone or written request for serv ice 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 instruc tions provided by Ohio Medical or altered without the prior written approval of Ohio Medical s Product Assurance Department The user of this product shall Technical Competence The procedures described in this service manual should be performed by trained and authorized personnel only Maintenance should only be undertaken by competent individuals who have a general knowledge of and expe rience with devices of this nature No repairs should ever be undertaken or attempted by anyone not having such qualifications User Responsibility 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 Corporation A WARNING Federal law in the U S A and Canada restricts this device to sale by or on the order of a licensed medical practiti
26. n dam age 3 Dry all components with a lint free cloth 4 Following cleaning sterilize according to section 5 2 6700 0011 000 RevD 5 2 Sterilization A CAUTION Do not steam autoclave or liquid ster ilize the regulator Severe impairment of the opera tion of the unit will result The only acceptable method of sterilization is with gas ethylene oxide The regulator requires sterilization if it becomes flooded with patient fluid during use is otherwise considered con taminated or is to be shipped or serviced The regulator may be sterilized using ethylene oxide ETO ETO ster ilization will not damage the regulator or its components except as noted see Caution below 1 Switch the regulator ON I and set the unit to the FULL INCREASE setting 2 Should disassembly be required follow directions in section 7 Service Disassembly and Assembly and handle in accordance with your hospital s infection control policy 3 Follow the sterilizer manufacturer s directions for the correct sterilization procedures Ohio Medical makes no claims with regard to sterilization effectiveness Sterilization is not recommended as a standard pro cedure after each use A CAUTION Sterilization with ethylene oxide mix tures may cause crazing minute superficial cracking of some plastic parts Crazing will be more pronounced when mixtures containing Freon are used 4 Adequately aerate the regulator prior to disassembly shipment
27. ol shaft in the regulator assembly assembled in the baffle guide plate Pull out the control shaft and remove the spring nut and O ring 1 Control Knob 0212 0806 100 2 Bent Metal Washer 0202 3042 300 3 Plastic Spacers 2 0202 0063 300 4 Cover Mounting Screws 4 0142 4113 108 Restrictor tubes and orifice kit Includes items 5 6 and 7 6700 0429 850 5 Restrictor Mounting Tube 6 Restrictor Orifice 7 Tube Gauge kit Includes items 8 and 9 Domestic us stveiseac S Raed nae 6700 0430 850 International 6700 0431 850 8 Barbed Fitting 9 Vacuum Gauge 10 Lens Cover 0 005 6700 0087 500 11 Label Domestic 0205 4366 300 International less 6700 0224 100 12 Front Cover ENnGlShis sc dot keane ae fond ne 6700 0155 400 French taedet des Seas 6700 0155 401 Spariish cose ixi eA 6700 0155 402 6700 0011 000 RevD 09 2007 7 2 7 Service Disassembly and Assembly 1 Vacuum Tube 0211 0072 300 2 Probe Adapter Mounting Screws 2 0140 6624 108 3 Probe Adapter connector 0206 5149 300 4 O N ajar ia aaa 0210 0629 300 SS NUS 42 Lass aa a a ee 6700 0175 400 6 Q ring sss ved et ee aes 0210 0629 300 7 On Off Selector switch International I O 6700 0092 701 Domestic ON OFF 6700 0092 700 8 Spring washer 0202
28. oner This device is to be used only by persons who have been adequately instructed in its use Important This document is not to be reproduced in any manner nor are the contents herein to be disclosed to anyone without the express authorization of Ohio Medical Corporation Gurnee IL U S A 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 attempt ed procedure Abbreviations Used In This Manual O Off On Regulate Ccw Counterclockwise Anti clockwise cw Clockwise in Inch in Hg Inches of mercury kPa Kilo Pascals kPa x 7 50 mm Hg kPa x 10 197 cm H20 lpm Liters per minute mm Millimeters mm Hg Millimeters of mercury mm Hg x 0 133 kPa mmHg x 1 3595 cm H2O cm H20 Centimeters of water cmH2O x 0 098 kPa cm H20 x 0 7355 mmHg C Degrees Celsius F Degrees Fahrenheit N m Newton Meter N m x 737 ft lb ft lb Foot Pound Force ft lb x 1 356 N m OZ Ounces DISS Diameter Index Safety System OES Oxequip Engineering Systems NCG National Compressed Gases Chemetron BOC British Oxygen Corporation NPT National Pipe Thread USA NPTF National Pipe Thread Female USA MPTS Multi Purpose Therapy Stand gal gallon 6700 0011 000 RevD 09 2007 1 Precautions 1 1 Definitions Note A Not
29. or switch to On l 5 Observe the Bubble Leak Tester No bubbles should appear within 10 seconds 1 4 D Clear Tubing with Knife Edge Sealed Water Bubble Leak Tester Bubble Leak Test Set Up 6700 0011 000 RevD 09 2007 8 3 9 Maintenance 9 1 General Maintenance of Suction Equipment A WARNING The Pre Use Check out Procedure must be performed before using this equipment on each patient If the regulator fails any part of the Pre Use Check out Procedure it must be removed from service and repaired by qualified service personnel A WARNING After patient use regulators may be contaminated Handle in accordance with your hos pital s infection control policy Vacuum Regulators should be kept in use or used on a rotating basis Unused equipment may tend to deterio rate Maintenance of the vacuum piping system is as impor tant as maintenance of the suction equipment The use of collection bottles with reliable shut off valves will pro tect the regulator and piping system The flow rate at the wall outlet should be checked on a yearly basis and suit able cleaning of the outlets should be performed The flow rate measurement should meet local standards 9 1 6700 0011 000 RevD 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
30. placing the unit back into service after disassem bly or cleaning perform the Service Check out Procedure 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 0011 000 RevD Use care when unhooking the tension spring from the regulator Excessive tension on the spring can crack the plastic at the base of the mounting post To prevent stripping the plastic threads place the screw in the hole and turn counterclockwise until it drops into the original threads Tighten screw Use of lubricants other than recommended may degrade plastic or rubber components Not for Field or Transport Uset Freon is a registered trademark of the DuPont Company T The categories of Field and Transport Use are specifically defined in ISO 10079 3 BS 7259 Part 2 Field means use at accidents or emergencies outside a hos pital Transport means use in ambulances cars or 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 09 2007 T2 2 Scope This service manual contains service maintenance and parts information for four models of the Thoracic Vacuum Regulator North American English French Spanish Note Parts numbers are for vacuum regulators without adapters
31. prevent stripping the plastic threads place the screw in the hole and turn counterclockwise until it drops into the original threads Tighten screw When installing the diaphragm orient it with its metal sec tion towards the metal piston of the regulator assembly The rim of the diaphragm should fit over the outside of the diaphragm seat for a good seal Do not lubricate the diaphragm Tighten the regulator assembly mounting screws in an X pattern to prevent warpage Do not over tighten the screws 7 5 6700 0011 000 RevD Before placing the front cover on a reassembled unit connect it to a functioning vacuum source and adjust the vacuum relief valve Refer to section 8 5 A WARNING The vacuum relief valve must be test ed to assure compliance with manufacturer s speci fications before the unit is placed in service Remove the unit from service if it fails the test Otherwise excessive suction can cause injury to a patient Ensure that the conductive wire if present between the probe adapter connector and the patient port fitting is properly connected 09 2007 Service Check Out Procedure 8 A WARNING If the vacuum regulator is repaired or disassembled in any manner the Service Check out Procedure must be performed before using the equipment on a patient Important This entire Service Check out Procedure must be performed in numerical order Mode Selector Switch Supply Vacuum Gauge 0 to m7
32. tch to ON I 2 Clamp the connective tubing to occlude the patient port 3 Rotate the suction control knob until the vacuum gauge indicates the required setting 4 2 3 Pre Use Check out Procedure The Pre Use Check out Procedure must be performed before using this equipment on each patient All tests must be performed with a supply vacuum of 300 mm Hg 40 kPa minimum 1 Turn the mode selector switch to OFF O Rotate the suction control knob one full turn clock wise increase s Clamp the connective tubing to occlude the patient port The gauge needle should not move 6700 0011 000 RevD 09 2007 4 2 4 Operation Pre Use Check out Procedure continued 2 Turn the mode selector switch to ON I Rotate the suction control knob fully counterclock wise decrease Clamp the connective tubing The gauge needle should not move 3 Clamp the connective tubing Increase the suction to 35 cm H2O 3 4 kPa Slowly open and close the clamped tubing to create various flow rates through the regulator Ensure that the suction level is maintained when the tubing is clamped 4 Clamp the connective tubing Rotate the suction control knob fully clockwise increase to verify that the relief valve opens begins to flow at 55 5 cm H2O 5 4 5 kPa As suction is increased the relief valve should not allow levels of more than 65 cm H20 6 4 kPa Thoracic
33. vailable Regulator amp Rail Bracket N L DISS Male 6713 1275 901 s lr Regulator amp Rail Bracket g dE DISS Hand I Twist and DISS male dE e 6722 1275 901 El 6700 0011 000 RevD 09 2007 Installation procedure for Probes adapters All probes adapters should be sealed and installed prop erly to prevent leaks and to support the equipment when mounted The probe adapter port is a 1 8 27 NPTF tapered pipe thread It is important to note that probes adapters seal on the thread and may have threads exposed after they have been tightened proper ly Prior to installing the probe adapter seal the thread with Teflon PTFE tape or one of the following lubricants Dow 111 6700 0074 200 6700 0011 000 RevD Appendix A CAUTION Do not use any Loctite products or prod ucts which contain Methacrylate Ester as an active ingre dient to seal the probe adapter threads The torque range for installing probes adapters is 4 0 ft Ib 5 4 N m minimum to 10 0 ft lb 13 6 N m maximum Probes adapters which are not keyed for specific orienta tion should be torqued to approximately 6 0 ft Ib 8 1 N m Probes adapters that are keyed to specific orientation must be torqued initially to 4 0 ft lbs Additional torque is applied only until orientation is correct 09 2007 A 1 Ohio Medical Corporation Hatin a Wy vw Ohio Medical Corporation Authorized Representative OxygenCare
34. warranty on vac uum regulators sold on or after July 1 2005 If the vacuum regulator was purchased on or after July 1 2005 and is less than ten years old or if the vacuum regulator is covered under the previous warranty and is less than five years old include the warranty infor mation that came with the device and a copy of the invoice Include a purchase order to cover repair of a regula tor not under warranty Ship the vacuum regulator prepaid Write your return address and billing address information on the pack age or letter that comes with the package For U S A Warranty Repairs purchased on or after July 1 2005 and is less than ten years old form the purchase date or if the vacuum regulator is covered under the previous warranty and is less than 5 years old from the purchase date mail the package to Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA For U S A Non Warranty Repairs more than ten years older under the new warrant or more than five years sold under the previous warranty mail the package to Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA In other locations contact your nearest Ohio Medical office or authorized Ohio Medical distributor 6700 0011 000 RevD 09 2007 Ordering Information 10 10 1 Service Parts See section 7 Service Disassembly and Assembly for listings of service parts 10 2 Adapters Probes p 1 Diamond Adapter 6700
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