Intermittent Suction Unit (ISU) - Maquet
Contents
1. 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 Ill 60031 USA P 866 549 6446 P 1 847 855 0800 F 1 847 855 6218 www ohiomedical com IFU 6700 0370 000 05 08 06 Rev C Printed in USA lo Medical Corporation Addendum Instructions for Use Intermittent Suction Unit 6700 0370 000 05 99 Additions for Pediatric ISU Definitions High Flow Low Vacuum high flow low vacuum Pre Use Checkout Procedure All tests must be performed with supply vacuum of 67 kPa 500 mm Hg minimum 3 REGULATOR SETTING Pediatric ISU Low increase the suction to 8 kPa 60 mm Hg Pediatric ISU Only Clamp tubing and rotate suction control knob fully clockwise increase to verify that the suction level does not exceed 21 kPa 160 mm Hg to verify this is a limited unit 6702. text Important Similar to a note but of greater emphasis AN Attention Alerts you to a warning or caution in the text MAX maximum High Flow High Vacuum high flow high vacuum High Flow Low Vacuum high flow low vacuum IOIOI INTER intermittent cycles on and off I Cont on O Off off Fas C European Union Representative 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
3. 0 0401 000 01 2006 1
4. C 05 08 06 Operation Figure 6 2 Occlude or clamp tubing O Clamp CS 20 008 Figure 7 3 Rotate the suction control knob until the vacuum gauge indicates the required setting I uc uL HT gt conn CS 02 034 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 the regulator fails any part of the Pre Use Checkout Pro cedure it must be removed from service and repaired by qualified service personnel 6700 0370 000 RevC 05 08 06 6 Operation All tests must be performed with supply vacuum of 67 kPa 500 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 Turn the mode selector switch to Cont Rotate the suction control knob fully anti clockwise decrease Clamp tubing The gauge needle should not move 3 Clamp tubing REGULATOR SETTING Intermittent Suction Standard increase the suction to 12 kPa 90 mm Hg Unit ISU High increase the suction to 40 kPa 300 mm Hg Pediatric ISU Low increase the suction to 8 kPa 60 mm Hg 4 Slowly open and close the clamped tubing to create various flow rates t
5. Ohio Medical Corporation Intermittent Suction Unit ISU Instructions for Use Regulator Identification Intermittent Suction Unit ISU Figure 1 D Vacuum Gauge Fitting Port 2 Mode Selector Switch Probe Adapter Port Suction Control Knob 1 6700 0370 000 RevC 05 08 06 CS 20 030 User Responsibility WARNINGS A This device is to be used only by persons who have been adequately instructed in its use A Donot 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
6. e manual After sterilization follow the service checkout procedures in section 8 of the regulator service manual WARNINGS 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 After patient use regulators may be contaminated Handle in accordance with your hospital s infection control policy 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 Do notsteam autoclave or liquid sterilize the regulator Severe impairment to the operation of the regulator will result 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 Remedy No suction Mode selector is Switch to Cont or in the O Off or O10 INTER position between positions Leak in system Check 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 No suction In the off cycle of In the IOIOI mode the the I0IOI mode regulator starts in the off cycle Wait at least 20 seconds to determine if the regulator is fu
7. hrough the regulator Check that the suction level is maintained when the tubing is clamped Pediatric ISU Only Clamp tubing and rotate suction control knob fully clockwise increase to verify that the suciton level does not exceed 21 kPa 160 mm Hg to verify this is a limited unit Turn the mode selector knob to IOIOI Clamp tubing Check that the timing cycles are approximately 15 seconds on and 8 seconds off by observing the gauge needle Note The ISU starts in the off cycle Reduce the suction to zero and set the mode selector to O off 6700 0370 000 RevC 05 08 06 Operation Patient Setup 1 Make sure the Pre Use Checkout Procedure has been performed Figure 8 2 Turn the mode selector switch to Cont and clamp tubing 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 tubing to the vacuum port of the collection container 6700 0370 000 RevC 05 08 06 8 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 See section 5 of the regulator servic
8. nctioning Important If the above actions do not correct the problems or other problems exist refer servicing to qualified service personnel 9 6700 0370 000 RevC 05 08 06 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 sixty 60 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 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 in
9. of the Overflow Safety Trap and suction filter will help prevent this and extend the life of suction equipment 3 6700 0370 000 RevC 05 08 06 Operation 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 position ing Lower sleeve to lock trap in position O Regulator 2 Sleeve DISS fitting Figure 3 Insert trap into the regulator fitting Situate the tubing in the desired position 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 Q Wing nut N co e Ex 72 e 6700 0370 000 RevC 05 08 06 4 Operation Mode Selection Figure 4 Note In this text the international graphic symbol will be written as IOIOI IOIOI suction is intermittent cycled on and off and the suction level can be adjusted with the suction control knob O No suction is supplied to the patient Suction is continuous and can be adjusted with the suction control knob CS 02 035 9 4 CONT Setting the suction level Figure 5 1 Turn the mode selector switch to Cont 5 6700 0370 000 Rev
10. 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 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 AN 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 6700 0370 000 RevC 05 08 06 2 Definitions WARNING possible injury to patient or operator CAUTION possible damage to equipment Note Provides additional information to clarify a point in the
11. structions 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 0370 000 RevC 05 08 06 10 hio Medical Corporation 8 KAN Ohio Medical Corporation Authorized Representative OxygenCare Ltd Corrig Road Sandyford Industrial Est Dublin 8 Ireland Phone 35 31 295 3421
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