USER MANUAL - Precision Medical
Contents
1. 10 DECLARATION 2 2 11 CONTINUOUS RECEIVING INSPECTION Remove the Precision Medical Inc Vacuum Regulator from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE The devices are intended to control and show the amount of vacuum from central vacuum system used in various medical suctioning procedures READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the Vacuum Regulator This is provided for your safety and to prevent damage to the Vacuum Regulator If you do not understand this manual DO NOT USE the Vacuum Regulator and contact your Provider EXPLANATION OF ABBREVIATIONS l min Liters Per Minute mmHg Millimeters of Mercury inHg Inches of Mercury kPa Kilopascal SAFETY INFORMATION WARNINGS AND CAUTIONS AWARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Indicates a potentially hazardous situation which if ACAUTION not avoided may result in minor or moderate injury Used without the safety alert symbol indicates CAUTION a potentially hazardous situation which if not avoided may result in property damage CONSULT ACCOMPANYING DOCUMENTS Symbol indicates the device complies with the requirements of Directive 93 42 EEC concerning 02. 3 2 Rule 11 of Annex IX of MDD We herein declare that the above mentioned products meet the provisions of the following EC Council Directives and Standards All supporting documents are retained under the premises of the manufacturer and the notified body Directives General Application Directives MDD Medical Device Directive Council Directive 93 42 EEC of 14 June 1993 Annex II Concerning Medical Devices of The European Parliament Applied Standards EN 980 EN 1041 EN ISO 14971 EN ISO 10079 3 Notified Body ATUVRheinland LGA Products GmbH 0197 Address Tillystrasse 2 90431 Nurnberg Germany Certification Registration No s HD60019110 0001 Date of Expiry 03 08 2012 Devices already manufactured S N traceability Device History Records Validity of DOC 11 01 11 to Date of Expiry Manufacture Representative Quality Manager Position Quality Systems ISO Representative Date of Issue 7 18 07 Tell us how we are doing Visit us at www precisionmedical com 503443 11 12 29 11 2 Printep in USA
3. l min LINE 82 I min MAXIMUM FLOW IS OBTAINED WITH A VACUUM SOURCE OF 21 Hg 71 1 kPa MAXIMUM FLOW IS OBTAINED WITH A VACUUM SOURCE OF 25 Hg 84 6 kPa MAXIMUM VACUUM PM3000 amp PM3100 REG Mode Full Vac 396 mmHg 53 kPa PM3200 REG Mode Full Vac 100 kPa 750 mmHg PM3500D Restricted to 170 mmHg 23 kPa 10 mmHg 1 3 kPa PM3500E Restricted to 160 mmHg 21 kPa PM3600 REG Mode Full Vac 760 mmHg 101 kPa Operating Environmental Limits O F to 122 F 18 C to 50 C Recommended Environmental Operating Limits 55 F to 85 F 13 C to 29 C Storage Environmental Limits Temperature Range 4 F to 140 F 20 C to 60 C Humidity Max 95 Noncondensing Battery 3 Volt Lithium 1 2 Specifications are subject to change without prior notice VACUUM REGULATOR z OPERATING INSTRUCTIONS CAUTION Inspect the Vacuum Regulator for visual damage before use DO NOT USE if damaged NOTE Overflow protection should be used with the Vacuum Regulator i e Filter Vac Trap Canister equipped with shut off 1 Turn the Selector Knob to the OFF position 2 Attach the Vacuum Regulator to the vacuum source A REG MODE Regulated Mode ALL MODELS 1 Turn the Selector Knob to the REG position 2 Block the bottom port of the Regulator 3 Using the Regulator Knob set the desired vacuum To INCREASE vacuum Turn Knob CLOCKWISE To DECREASE vacuum Turn Knob COUNTERCLOCKW
4. shown in Cleaning Illustration on previous page Turn the working Vacuum Regulator on to a continuous regulated mode Adjust the vacuum to a minimum of 120 mmHg Set the Vacuum Regulator to be cleaned to the REG mode and set at 100 mmHg Allow cold disinfection sterilization solution to pass through and collect in Suction Canister Procedure should continue for time recommended by the manufacturer of the cold disinfection sterilization solution for the desired level of disinfection or sterilization Turn the Vacuum Regulator to be cleaned to the LINE mode if applicable Allow remaining cold disinfection sterilization solution to pass through and collect in Suction Canister Set working Vacuum Regulator to its maximum vacuum setting Thoroughly dry the internal components by drawing maximum vacuum through the Regulator to be cleaned for at least 30 seconds in both REG and LINE modes if applicable NOTE If it is not possible to pass cold disinfection sterilization solution through the Regulator then the passageways are totally blocked and DISASSEMBLY of the Regulator is required Be sure to follow your facilities Biohazard protocol MAINTENANCE Before each use visually inspect Vacuum Regulator for any sign of damage DO NOT USE if damaged RETURNS Returned products require a Returned Goods Authorization RGA number contact Precision Medical Inc All returns must be packaged in sealed
5. 197 medical devices and all applicable International Standards On CE marked Devices ONLY AWARNING DO NOT use this Vacuum Regulator for anything other than its Intended Use Personal injury and or damage to Regulator may result from misuse Only personnel instructed and trained in its use should operate this Vacuum Regulator VACUUM REGULATOR SPECIFICATIONS GAUGE RANGE Counterclockwise direction PM3000 0 200 mmHg Full Vacuum PM3100HV 0 300 mmHg Full Vacuum PM3000E 0 200 mmHg 0 26 kPa PM3200E 0 100 kPa 750 mmHg Full Vacuum PM3000HV 0 300 mmHg Full Vacuum PM3500 0 150 mmHg PM3100 0 200 mmHg Full Vacuum PM3500E 0 200 mmHg 0 26 kPa PM3100E 0 200 mmHg 0 26 kPa PM3600 0 760 mmHg PM3100EHV 0 300 mmHg 0 40kPa PM3600E 0 760 mmHg 0 100 kPa GAUGE ACCURACY Analog 5 of MAX Digital Analog Dual Gauge Digital Display 1 of Full Scale Analog Gauge 5 of MAX within ref Indicator VACUUM PORTS 1 8 NPT Female MODES PM3100 PM3200E3 amp PM3600 Series LINE Provides maximum continuous vacuum from the vacuum source OFF No Vacuum REG Regulated provides an adjustable continuous vacuum level PM3000 PM3200E amp PM3500 Series OFF No Vacuum REG Regulated provides an adjustable continuous vacuum level FLOW Models Mode Max Flow PM3000 PM3100 PM3200 amp PM3500 51 l min 55 I min PM3600 SERIES 71
6. HV Vac Reg N A RK6000DEHV PM3100 PM3100D Vac Reg RK6100 RK6100D PM3100E PM3100DE Vac Reg RK6100E RK6100DE PM3100HV PM3100DHV Vac Reg RK6100HV RK6100DHV PM3100EHV PM3100DEHV Vac Reg RK6100EHV RK6100DEHV PM3200E Vac Reg RK6200E N A PM3500 PM3500D Vac Reg RK6500 RK6500D PM3500E PM3500DE Vac Reg RK6500E RK6500DE PM3600 PM3600D Vac Reg RK6600 RK6600D 600 PM3600DE Vac Reg RK6600E RK6600DE Not all Repair Kits are listed above contact Precision Medical Inc for availability DISASSEMBLY INSTRUCTIONS Reference PARTS DESCRIPTION 1 Loosen the Set Screw 11 in Selector Knob 2 Pull the Control Knob Assembly Item 12 away from case The Regulator Module Item 10 is threaded onto the Control Knob Assembly Remove the screws Item 2 from the back of the Regulator 4 Separate the Case Assembly Item 9 by pulling it away from the Housing Assembly Item 1 5 Remove the Selector Assembly Item 6 by pulling it away from the Housing Assembly Item 1 6 Remove the Gauge Assembly Item 3 ASSEMBLY INSTRUCTIONS 1 To assemble perform the DISASSEMBLY INSTRUCTIONS in reverse order NOTE Ensure the Selector Assembly is inserted into the control knob assembly with the groove in the 12 o clock position e Ensure tabs and slots on various components are properly aligned and engaged when reassembling 2 Lubricate all O rings and cavities with Vacuum grease part 1775 supplied in t
7. ISE B LINE MODE Full unregulated vacuum PM3100 amp PM3600 SERIES ONLY 1 Turn the Selector Knob to the LINE position 3 Turn the Selector Knob to the OFF position to turn the Regulator off AWARNING e When turning the Vacuum Regulator to REG from LINE or OFF the vacuum level will return to its previously regulated setting Vacuum may be set at improper level for procedure ALWAYS confirm vacuum setting prior to performing procedure The vacuum CANNOT be regulated when the Selector Knob is set to the LINE position Full Line Vacuum is present between settings REGULATE MODE Turn selector knob fully clockwise to the regulator mode and confirm vacuum setting before use LINE MODE Turn the selector knob fully counterclockwise for line vacuum and confirm vacuum settings before use ACAUTION DO NOT operate the Vacuum Regulator when the collection canister is This may cause loss of vacuum and damage to the Vacuum Regulator This will void the warranty VACUUM REGULATOR 4 PARTS DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc 1 3 Analog 3 Digital Selector Knob QUANTITY a Danno 4 6 PLACES PARTS LIST PM3200 Models contact Precision Medic
8. USER MANUAL VACUUM REGULATOR CONTINUOUS MODEL SERIES PM3000 PM3100 shown PM3200 PM3500 PM3600 SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by or on the order of a physician PRECISION MEDICAL 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 ISO 13485 Certified www precisionmedical com CONTENTS RECEIVING INSPECTION 2 INTENDED errr te 2 READ ALL INSTRUCTIONS BEFORE 2 EXPLANATION OF ABBREVIATIONS 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 OPERATING INSTRUCTIONS 4 PARTS DESCRIPTION 5 PARTS LIS ire nee earn tee erty oe ar teen ner een rere 5 REPAIR KITS eisirean eaa aa aTa 6 DISASSEMBLY 6 ASSEMBLY 5 6 VACUUM REGULATOR CLEANING ILLUSTRATION 7 CLEANING 8 8 RETURNS aaen 8 DISPOSAL INSTRUCTIONS ossessi 9 TROUBLESHOOTING EE REA 9 LIMITED WARRANTY
9. al Inc No Description PM3000 PM3100 PM3500 PM3600 1 Housing Assembly l 1561 Check Valve Export E m m 502230 NA 2 Screw l 503956 505152 503956 3 Analog Gauge Assembly 503694 505163 503826 505162 505937 Analog Gauge Assembly Export E 503923 504225 Analog Gauge Assembly HV 504309 Analog Gauge Assembly Export E HV 506384 506555 Digital Assembly 505244 0 200 mmHg 505391 0 150 mmHg 505938 Digital Assembly HV 505392 0 300 mmHg Digital Assembly Export E 506036 506034 506040 Digital Assembly Export E HV 506038 0 300 mmHg 4 Snubber l 1396 5 O ring l 1016 6 Selector Assembly 1563 1564 1563 505935 7 Selector Ring 502685 8 Wave Spring Washer l 1614 505154 1614 9 Case Assembly l 1565 1566 1565 1566 10 Regulator Module Assembly 1567 505164 505962 1567 505164 505962 Washer metal M 502818 Washer plastic NA NA 503879 NA 11 Set Screw l 1391 505158 1391 12 Control Knob Assembly l 1568 505165 1568 Battery for Digital Assembly l 8066 MRI Models ONLY PM3000MR PM3100MR amp PM3500MR HV Models ONLY PM3000HV amp PM3100HV VACUUM REGULATOR CONTINUOUS 5 REPAIR KITS Analog Part Digital Part PM3000 PM3000D Vac Reg RK6000 RK6000D PM3000E PM3000DE Vac Reg RK6000E RK6000DE PM3000DHV Vac Reg RK6000HV RK6000DHV PM3000DE
10. clusive statement of the terms of that contract THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED Precision Medical Inc shall not under any circumstances be liable for special incidental or consequential damages including but not limited to lost profits lost sales or injury to person or property Correction of non conformities as provided above shall constitute fulfill ment of all liabilities of Precision Medical Inc whether based on contract negligence strict tort or otherwise Precision Medical Inc reserves the right to discontinue manufacture of any product or change product materials designs or specifications without notice Precision Medical Inc reserves the right to correct clerical or typographical errors without penalty VACUUM REGULATOR DECLARATION OF CONFORMITY Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Emergo Europe European Office REP Molenstraat 15 0 1 0 T 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Vacuum Regulators PM3000E PM3000DE PM3000DEHV PM3100E PM3100DE PM3100DE MG PM3100DEHV PM3100DEIN PM3100EHV PM3100EHV Y PM3100EIN PM3200E PM3200E Y PM3200E3 PM3500E PM3500E MG PM3500DE PM3500DE LB PM3600E PM3600DE Classification lla Classification criteria Clause
11. containers to prevent damage Precision Medical Inc will not be responsible for goods damaged in transit Refer to Precision Medical Inc Return Policy available on the Internet www precisionmedical com Manuals available on our website www precisionmedical com VACUUM REGULATOR 8 DISPOSAL INSTRUCTIONS Dispose of the Vacuum Regulator in accordance with the local regulations Please Recycle ve LY AWARNING Product should be cleaned before being disposed of Potential for Biohazard TROUBLESHOOTING If the Vacuum Regulator fails to function consult the Troubleshooting Table below If problem cannot be solved consult your Provider Problem Probable Cause Remedy No vacuum at bottom port gauge at zero 1 Regulator turned OFF 2 Loose connection 3 No vacuum to Regulator 4 Clogged vacuum Port 1 a Turn selector knob b Adjust Regulator knob 2 Tighten connection 3 Connect to a known working vacuum source 4 Disassemble amp clean No vacuum at bottom port gauge showing vacuum Vacuum at bottom port No reading on gauge when port is blocked Clogged Regulator Defective Gauge Disassemble amp clean Replace Gauge Gauge will not return to zero 1 Clogged Snubber 2 Damaged Regulator Module 3 Defective Gauge 1 Replace Snubber 2 Replace Regulator Module 3 Replace Gauge Vacuum Regulator erratic 1 D
12. he Vacuum Regulator Repair Kit 3 Repeat steps 1 through of OPERATING INSTRUCTIONS 4 Prior to returning Vacuum Regulator to service verify accuracy of gauge VACUUM REGULATOR 6 VACUUM REGULATOR CLEANING ILLUSTRATION Cleaning Decontamination Instructions on page 8 Vacuum Regulator 2 To Be Cleaned Regulator Suction z Tubing Suction Tubing Cold Patient Disinfection Port Suction Sterilization Collection Solution Canister CAUTION DO NOT autoclave or immerse in liquid This will cause damage to the Vacuum Regulator and will void the warranty If Vacuum Regulator becomes internally contaminated warranty is voided DO NOT send back to Precision Medical Inc for repair Follow your facilities contaminated equipment protocol Be sure all connections are tight and leak free This Vacuum Regulator contains magnetic ferrous material that may affect the results of an MRI Model Series PM3000MR PM3100MR amp PM3500MR are MRI safe designated by MRI label Ss 2 MRI Safe VACUUM REGULATOR CLEANING DECONTAMINATION As needed 10 11 Attach working Vacuum Regulator with continuous regulated mode to a minimum vacuum source of 15 inHg Mix cold disinfection sterilization solution according to its manufacturer s directions Connect tubing as
13. irty Regulator Module Defective Regulator Module 1 Disassemble amp clean Lubricate O ring 2 Replace Module Stiff movement of Selector Knob 1 Dirty Regulator Module and or Selector Module 1 Disassemble amp clean Lubricate O rings No digital display Dead battery Replace battery VACUUM REGULATOR CONTINUOUS LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Medical Vacuum Regulator the Product will be free of defects in workmanship and or material for the following period Ten 10 years from date of shipment Should any failure to conform to this warranty appear within the applicable period Precision Medical Inc shall upon written notification thereof and substantiation that the goods have been stored installed maintained and Operated in accordance with Precision Medical Inc s instructions and standard industry practice and that no modifications substitutions or alterations have been made to the goods correct such defect by suitable repair or replacement at its own expense ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES The representative of Precision Medical Inc or any retailers are not authorized to make oral warranties about the merchandise described in this contract and any such statements shall not be relied upon and are not part of the contract for sale Thus this writing is a final complete and ex
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