Thoracic Vacuum Regulator - Instruction Manual - Maquet
Contents
1. KAN Ohio Medical Corporation Authorized Representative OxygenCare Ltd Corrig Road Sandyford Industrial Est Dublin 8 Ireland Phone 35 31 295 3421 North America United States Customer Service and Distribution Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA P 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 Technical Support Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA P 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 Sales and Service Ohio Medical Corporation 1111 Lakeside Drive Gurnee IL 60031 USA P 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 Equipment Service Center Ohio Medical Corporation1 111 Lakeside Drive Gurnee IL 60031 USA P 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 Ohio Medical Corporation 1111 Lakeside Drive Gurnee II 60031 USA P 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 www ohiomedical com IFU 6700 0373 000 12 01 05 RevB Printed in USA2. 30 days with respect to the expendable parts The foregoing warranties shall not apply if the Product has been repaired other than by Ohio Medical or in accordance with written instructions provided by Ohio Medical or altered by anyone other than Ohio Medical or if the Product has been subject to abuse misuse negligence or accident Ohio Medical s sole and exclusive obligation and Buyer s sole and exclusive remedy under the above warranties is limited to repairing or replacing free of charge at Ohio Medical s option a Product which is telephonically reported to the nearest Ohio Medical Regional Service Office and which if so advised by Ohio Medical is thereafter returned with a statement of the observed deficiency not later than seven 7 days after the expiration date of the applicable warranty to the designated Ohio Medical Service Office during normal business hours transportation charges prepaid and which upon Ohio Medical s examination is found not to conform with the above warranties Ohio Medical shall not be otherwise liable for any damages including but not limited to incidental damages consequential damages or special damages There are no express or implied warranties which extend beyond the warranties hereinabove set forth Ohio Medical makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof 6700 0373 000 12 01 05 10 hio Medical Corporation
3. Representative Operation Figure 1 Thoracic Vacuum Regulator Mode Selector Switch Probe Adapter Port Vacuum Gauge Inlet Fitting Suction Control Knob CS 18 029 CS 04 005 6700 0373 000 12 01 05 2 Operation Equipment Setup Insert the probe into the vacuum wall outlet If the regulator is mounted elsewhere connect a vacuum supply hose between the regulator s probe adapter and the wall outlet WARNING A Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment Use hospital supplied suction tubing between the end piece and the collection container and between the patient port and the patient minimum inside diameter is 6 mm 0 25 in An Ohmeda High Flow Suction Filter should be used between the collection container and regulator to prevent contamination of the regulator ISO 10079 3 BS 7259 Part 2 section 5 1 2 states that the usable volume of the collection container shall not be less than 500 ml Suction Filters Carton of 20 6730 0350 800 Carton of 200 6730 0351 800 Attaching the Safety Trap CAUTION A Tohelp prevent aspirate from entering the regulator as a result of misuse an Overflow Safety Trap should be attached prior to its use Aspirate in the regulator may impair its operation The use of the Overflow Safety Trap and suction filter will help prevent this and extend the life of
4. container 7 Connect the regulator to a reusable water seal or a disposable system with a water seal WARNING A A water seal must be used with the thoracic regulator to prevent air from entering the pleural cavity and to indicate the presence of air leaks in the lungs and or the collection system 8 With reusable collection systems connect the water seal to the vacuum port of the collection container 9 Attach the patient tubing to the patient port of the collection container 10 Turn the mode selector switch to on 11 Clamp the patient tubing After a brief period the bubbling in the water seal should stop WARNING A With the patient tubing occluded all the bubbling in the water seal should stop If bubbling does not stop check all connections to eliminate leaks 12 Release the clamp on the patient tubing WARNINGS A When a leak free collection system connected to a patient is turned on and after initial air in the system is eliminated only patient air will produce bubbles in the water seal A Do not clamp the tubing between the patient and the collection bottle a pressure build up in the catheter and tubing will result Cleaning Cleaning the regulator is recommended as a standard procedure after each use Wipe all exterior surfaces with a solution of water and mild detergent Should misuse occur resulting in accidental flooding of the regulator the regulator may be sterilized using ethylene oxide ETO Se
5. 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 the service manual solely for convenience of users having proper knowledge tools and test equipment and for service representa tives trained by Ohio Medical A Not for field or transport use The categories of Field and Transport Use are specifically defined in ISO 10079 3 BS 7259 Part 2 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 Ohmeda suction equipment has not been tested to comply with the specific requirements of these categories 1 6700 0373 000 12 01 05 Definitions WARNING possible injury to patient or operator CAUTION possible damage to equipment Note Provides additional information to clarify a point in the text Important Similar to a note but of greater emphasis A Attention Alerts you to a warning or caution in the text Low Vacuum high flow low vacuum I On on O Off off ae C European Union
6. suction equipment Figure 2 Trap fitting 1 Raise the sleeve and insert the trap into the regulator fitting Turn the trap clockwise about one and a half turns to engage the threads The trap does not need to be screwed tight an O ring in the regulator fitting provides a vacuum seal The trap should rotate freely to allow the desired tubing positioning 3 Lower sleeve to lock trap in position O Regulator Sleeve 3 6700 0373 000 12 01 05 Operation Mode Selection Figure 3 I On I On Suction can be adjusted with the suction N control knob O Off No suction is supplied to the patient O Off CS 18 030 WARNING A A positive pressure relief valve in the Thoracic regula tor will prevent pressure buildup in the system only if the system is not clamped between the regulator and patient Setting the suction level Fi 4 igure K n Turn the mode selector switch to on Pe N Figure 5 2 Occlude or clamp tubing O Clamp 6700 0373 000 12 01 05 Operation Figure 6 3 Rotate the suction control knob until the vacuum gauge indicates the required setting CS 18 032 WARNING A The regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction Pre Use Checkout Procedure WARNING A The Pre Use Checkout Procedure must be performed before using the equipment on each patient If t
7. 373 000 12 01 05 6 Operation Figure 8 Setup with disposable collection system 3 Turn the mode selector switch to On clamp tubing and occlude vent on disposable collection system O Clamp occlude vent Ne Disposable Chest Drain i 8 TT TTT Ty EEK TE Tl TTT WARNING A When using a disposable collection system the atmo spheric vent at the top of the suction control chamber must be occluded for proper suction regulation with the Thoracic regulator Important Once the atmospheric vent is occluded the Thoracic regulator controls vacuum level regardless of the presence or amount of water in the suction control chamber 4 Setthe 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 required suction Important Subtract 2 cm water seal amount from the level set on the regulator gauge to determine the total suction level applied to the patient WARNING A Continuing to rotate the suction control knob past the point where the relief valve opens may result in suc tion levels higher than the preset relief pressure 5 Turn the mode selector switch to O Off 7 6700 0373 000 12 01 05 Operation 6 Attach tubing to the vacuum port of the collection
8. Occlude vent Rotate the suction control knob in the increase direction clockwise Clamp patient tubing and rotate suction control knob in the decrease direction anti clockwise Important If the above actions do not correct the problems or other problems exist refer servicing to qualified service personnel 9 6700 0373 000 12 01 05 Warranty This Product is sold by Ohio Medical under the warranties set forth in the following paragraphs Such warranties are extended only with respect to the purchase of this Product directly from Ohio Medical or Ohio Medical s Authorized Dealers as new merchandise and are extended to the first Buyer thereof other than for purpose of resale For a period of thirty six 36 months from the date of original delivery to Buyer or to Buyer s order but in no event for a period of more than two years from the date of original delivery by Ohio Medical to an Ohio Medical Authorized Dealer this Product other than its expendable parts is warranted to be free from functional defects in materials and workmanship and to conform to the description of the Product contained in this operation manual and accompanying labels and or inserts provided that the same is properly operated under conditions of normal use that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided This same warranty is made for a period of thirty
9. Ohio Medical Corporation Thoracic Vacuum Regulators Instructions for Use User Responsibility WARNINGS A This device is to be used only by persons who have been adequately instructed in its use A Do not use this device in the presence of flammable anesthetics Static charges my not dissipate and a possible explosion hazard exists in the presence of these agents This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and or inserts when assembled operated maintained and repaired in accordance with the instructions provided This Product must be checked periodically A defective Product should not be used Parts that are broken missing plainly worn distorted or contaminated should be replaced immediately Should such repair or replacement become necessary Ohio Medical recommends that a telephone or written request for service advice be made to the nearest Ohio Medical Regional Service Center This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ohio Medical and by Ohio Medical trained personnel The Product must not be altered without the prior written approval of Ohio Medical s Quality Assurance Department The user of this Product shall have the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration by anyone
10. e section 5 of the regulator service manual After sterilization follow the service checkout procedures in section 8 of the regulator service manual WARNINGS A After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy A Clean and sterilize all suction equipment before ship ment to ensure transportation personnel and service personnel are not exposed to any hazardous contami nation 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 54 C 130 F CAUTION A Donotsteam autoclave or liquid sterilize the regulator Severe impairment to the operation of the regulator will result 6700 0373 000 12 01 05 8 Troubleshooting If the regulator does not operate and you have performed the Pre Use Checkout Procedure the following procedures may be used to attempt to correct the problem Problem Possible Cause No suction Mode selector is in the O Off position or between positions Leak in system Atmospheric vent open disposable only Suction control knob at full decrease Regulator Limit of negative makes loud pressure relief valve venting is reached sound Remedy Switch to On Check lid is secure on the collection container Check tubing connections Check tubing and replace if necessary
11. he regulator fails any part of the Pre Use Checkout Pro cedure it must be removed from service and repaired by qualified service personnel All tests must be performed with supply vacuum of 40 kPa 300 mm Hg minimum 1 Turn the mode selector switch to O Off Rotate the suction control knob one full turn clockwise increase Clamp tubing to occlude the fitting port The gauge needle should not move 2 Turn the mode selector switch to On Rotate the suction control knob fully anti clockwise decrease Clamp tubing The gauge needle should not move 3 Clamp tubing and increase the suction to 35 cm H O Slowly open and close the clamped tubing to create various flow rates through the regulator Check that the suction level is maintained when the tubing is clamped Rotate the suction control knob fully clockwise increase to check that the relief valve activates between 50 to 60 cm H O When the relief valve opens a venting sound will be produce Reduce the suction to zero and set the mode selector switch to O Off 5 6700 0373 000 12 01 05 Operation Patient Setup 1 Make sure the Pre Use Checkout Procedure has been performed Figure 7 Setup with reusable collection system 2 Turn the mode selector switch to On and clamp tubing O Clamp 6700 0
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