Continuous Vacuum Regulators
Contents
1. On Important The Low models do not deliver suction in excess of 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa 7 6700 0371 000 7 Cleaning Troubleshooting 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 Should misuse occur resulting in accidental flooding of the regulator the regulator may be sterilized using ethylene oxide ETO See section 5 2 Sterilization of the regulator service manual After sterilization follow the service checkout procedures in section 8 Service Checkout Procedure of the regulator service manual 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 WARNINGS 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 Follow your hospital sterilization procedure A Clean and sterilize all suction equipment before shipment to ensure transportation personnel and service personnel are not exposed to any hazardous contamination A After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy Troubleshooting If the regulator doe2. Attaching the Overflow Safety Trap OST CAUTION A Tohelp prevent aspirate from entering the regulator wall outlet and pipeline equipment an overflow 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 overflow safety trap and suction filter will help prevent this and extend the life of suction equipment Trap fitting Figure 2 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 Lower sleeve to lock trap in position Regulator Sleeve 4 6700 0371 000 4 Operation DISS fitting Figure 3 1 Insert trap into the regulator fitting Situate the tubing in the desired position 2 Turn the DISS wing nut clockwise to engage threads and tighten there is no O ring so the vacuum seal depends on a tight connection Regulator es Wing nut Mode Selection Figure 4 2 Mode Continuous I On Suction can be adjusted with the suction control O Off No suction supplied to the patient Figure 5 3 Mode Continuous MAx Maximum full line vacuum is supplied to the patient Note Available on T
3. Ohio Medical Corporation and the Ohio Medical Corporation Logo are registered trademarks of Ohio Medical Corporation 6700 037 1 000 11 2012 Rev5
4. 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 2 6700 0371 000 2 Definitions 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 representatives trained by Ohio Medical A Not for field or transport use The categories of Field and Transport Use are specifically defined in SO 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 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 maximum High Flow High Vacuum high flow high vacuum High Flow Low Vacuum high flow low vacuum On on O Off off kPa Kilopascal mL Milliliter mm Millimeter Regulator Identification Continuous Vacuum Regulator Figure 1 O Mode Selector Switch Pr
5. 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 User Responsibility This Product will perform as described in this operating manual and accompanying labels and or inserts when assembled operated maintained and repaired in accordance with the instructions provided This Product must be checked periodically A defective Product should not be used Parts that are broken missing 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 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
6. clamped increase the suction to 90 mmHg 12 0 kPa 9 Slowly open and close the clamped tubing to create various flow rates through the regulator Check that the suction level is maintained at 5 of full scale deflection when the tubing is clamped For Standard Two Mode Continuous go to step 11 10 High and Standard Three Mode Continuous ONLY a Turn the mode selector to MAX b Clamp the connective tubing and check that the gauge needle indicates the maximum available suction c Turn the mode selector to On 11 Low Continuous ONLY Clamp the connective tubing and rotate knob fully clockwise increase to verify the suction level does not exceed 135 mmHg 5 mmHg 18 0 kPa 0 7 kPa 12 Reduce the suction level to zero and set the mode selector switch to O Off Patient Setup 1 Make sure the Pre Use Checkout Procedure has been performed Figure 9 2 Clamp the connective tubing and turn the mode selector switch to I On Clamp 3 Set the prescribed suction level WARNING A The regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction 4 Turn the mode selector switch to O Off 5 Attach the connective tubing to the vacuum port of the collection container 6 Turn the mode selector switch to
7. hree mode vacuum regulators ONLY O Off On 5 6700 0371 000 5 Operation Setting the suction level Figure 6 1 Clamp the connective tubing to occlude the fitting port Clamp Figure 7 2 Turn the mode selector switch to On Figure 8 3 Rotate the suction control knob until the vacuum gauge indicates the required setting WARNING A The regulator fitting port or patient connector 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 the regulator fails any part of the Pre Use Checkout Procedure it must be removed from service and repaired by qualified service personnel All tests must be performed with the regulator in its normal vertical operating position with a minimum supply vacuum of 500 mmHg 66 7 kPa 1 Turn the mode selector switch to O Off 2 Rotate the suction control knob one full turn clockwise increase 3 Clamp the connective tubing to occlude the fitting port The gauge needle should not move 6 6700 0371 000 6 Operation 4 Unclamp the connective tubing 5 Turn the mode selector switch to On 6 Rotate the suction control knob fully counter clockwise decrease 7 Clamp the connective tubing The gauge needle should not move 8 With the connective tubing
8. io Medical Corporation always there for life Continuous Vacuum Regulators Instructions for Use 6700 037 1 000 Rev 5 11 2012 Table of Contents Safety Instructions ccsssssssseeeeseeeeeeeeeeeeeeees 2 Intended use cc Se ec eee en ccna nace 2 Receiving INSpection cccccsccceeeeeeeeeseeeeees 2 User Responsibility wi sstecccsccs ccc centctetendcensecesteenenes 2 DG RIMIIONS cscri EE EEEE EEEa 3 Regulator Identification ccceeeeeeeeeeeeeeeees 3 OperatiON sispiasii nonii anaana uarias apa arai 4 Cleaning esta ss oe scene cence ee Septea decrease eed aeeeese 8 Troubleshooting ccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeees 8 Warranty scsi lceeececes cases ee aerate 9 Safety Instructions This manual provides you with important information about the Continuous Vacuum Regulators CVR To ensure the safe and proper use of this device READ and UNDERSTAND all of the safety and operating instructions IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS OR HAVE ANY QUESTIONS CONTACT YOUR SUPERVISOR DEALER OR THE MANUFACTURER BEFORE ATTEMPTING TO USE THE DEVICE Intended Use The vacuum regulator is intended to be used in the medical facility as a means to evacuate media i e fluids from the body 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
9. obe Adapter Port Vacuum Gauge Fitting Port suction Control Knob 3 6700 0371 000 3 Operation Equipment Set up Insert the probe into the vacuum wall outlet If the regulator is mounted elsewhere connect a vacuum supply hose between the regulator s probe adapter and the wall outlet A WARNING Connection to positive pressure sources such as oxygen and medical air even momentarily could injure the patient or operator AN CAUTION Connection to positive pressure sources such as oxygen and medical air even momentarily could 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 Ohio Medical overflow safety trap and high flow suction filter should be used between the collection container and regulator to prevent contamination of the regulator Hospital supplied suction tubing must be used between the catheter and the collection bottle Recommended minimum inside diameter is 0 25 in 6 mm ISO 10079 3 section 5 1 2 states that the usable volume of the collection container shall not be less than 500 mL High Flow Suction Filters Hydrophilic Hydrophobic Tubing x 1 8 NPT x tubing nipple tubing nipple Pkg of 20 6730 0350 800 Pkg of 3 6730 0570 800 6730 0580 800 Pkg of 200 6730 0351 800 Pkg of 10 6730 057 1 800 6730 0581 800 Pkg of 100 6730 0572 900 6730 0582 800
10. period for all expendable parts of the Product is sixty 60 days from the date the Company ships the Product to the customer The Company s sole and exclusive obligation and customer s sole and exclusive remedy under the above warranty is limited to repair or replacement at the Company s option of the defective Product The foregoing warranty shall not apply if the Product has been repaired or altered by anyone other than the Company or an authorized dealer or if the Product has been subjected to abuse misuse negligence or accident The Company reserves the right to stop manufacturing any product or change materials designs or specifications without notice This warranty is extended to only the initial customer with respect to the purchase of this Product directly from the Company or an authorized dealer as new merchandise Dealers are not authorized to alter or amend the warranty of any Product described in this agreement Any statements whether written or oral will not be honored or be made part of the agreement of sale THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE THE COMPANY SHALL NOT BE LIABLE FOR INCIDENTAL COLLATERAL CONSEQUENTIAL OR SPECIAL DAMAGES INCLUDING BUT NOT LIMITED TO LOST PROFITS OR LOSS OF USE THE COMPANY S LIABILITY IN THE AGGREGATE SHALL NOT EXCEED THE PURCHASE PRICE OF THE PRODUCT In o
11. rder to file a warranty claim customer is required to return Product prepaid to the Company at 1111 Lakeside Drive Gurnee IL 60031 USA As determined at the sole discretion of the Company Products which qualify under the warranty will be repaired or replaced at the Company s option and returned to customer via ground delivery at the Company s expense All claims for warranty must first be approved by Ohio Medical Corporation Customer Service Department For US Domestic customer returns customer service ohiomedical com or 1 800 662 5822 Option 3 For International customer returns intl customerservice ohiomedical com or 1 800 662 5822 Option 3 Upon approval the customer service department will issue a Return Goods Authorization RGA number An RGA must be obtained prior to commencement of any warranty claim Form No 550022 Rev 1 2012 9 6700 0371 000 9 io Medical Corporation always there for life Customer Service Distribution Center Technical Support Sales and Service Equipment Service 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 2012 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
12. s 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 Remedy No suction Mode selector is in the O Off Switch to I On position or between positions Leak in system Check that lid is secure on the collection container Check tubing connections Suction control knob Rotate the suction control at full decrease knob in the increase direction clockwise Important If the above actions do not correct the problems or other problems exist refer to CVR service manual or refer servicing to qualified service personnel 8 6700 0371 000 8 Warranty This Product is sold by Ohio Medical Corporation a Delaware corporation the Company under the express terms of the warranty set forth below For a period of SIXTY 60 MONTHS from the date the Company ships this Product to the customer but in no event for a period of more than five years from the date of original delivery by the Company to an authorized dealer this Product other than its expendable parts is warranted to be free from functional defects in materials and workmanship and to conform in all material respects to the description for the Product contained in this operation manual if this Product is properly operated under conditions of normal use regular periodic maintenance and service is performed and repairs are made in accordance with this operation manual The warranty
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