user manual - Precision Medical
Contents
1. CLEANING DECONTAMINATION As needed 1 Attach a working Vacuum Regulator with a continuous regulated mode to a minimum vacuum source of 15 inHg 2 Mix cold disinfection sterilization solution according to its manufacturer s directions Connect tubing as 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 7 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 8 Set working Vacuum Regulator to its maximum vacuum setting 9 Thoroughly dry the internal components by drawing maximum vacuum through the Regulator to be cleaned for at least 30 seconds in REG mode NOTE f 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 Precisio2. a delay occurs before the intermittent cycle begins 3 Turn the Selector Knob to the OFF position to turn the Regulator off AWARNING e ALWAYS confirm vacuum setting prior to performing procedure e When turning the Vacuum Regulator to REG or INT from any position the vacuum level will return to its previously regulated setting e Full Line Vacuum is present between settings e Vacuum levels will remain the same when switching from one mode to the other ACAUTION DO NOT operate the Vacuum Regulator when the collection canister is full This may cause loss of vacuum and damage to the Vacuum Regulator This will void the warranty n ai nh PARTS DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc 2 QUANTITY 6 PLACES 3 Analog 3 Digital PM3400 PM3400E Selector PARTS LIST No Description PM3300 PM3400 1 Housing Assembly 502102 2 Screw 503956 3 Analog Gauge Assembly 503694 503826 Analog Gauge Assembly Export E 503923 504225 Analog Gauge Assembly HV 504309 Digital Assembly 505244 0 200 mmHg 505391 0 150 mmHg Digital Assembly HV 505392 0 300 mmHg Digital Assembly Export E 506036 506034 Digital Assembly Export E HV 506038 4 Snubber 1396 5 O ring 502231 6 Selector Assembly 1805 7 Index Ring 502685 8 Wave Sp
3. 8570 Fax 31 0 70 346 7299 Vacuum Regulators PM3300E PM3300E P PM3300EHV PM3300DE PM3300DE G PM3300DE MG PM3300DE Y PM3300DEHV PM3300DEHV MG PM3400E PM3400DE Classification lla Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD We hereby declare that an examination of the under mentioned production quality assurance system has been carried out following the requirements of the UK national legislation to which the undersigned is subjected transposing Annex II 3 of the Directive 93 42 EEC and Directive 2007 47 EC on medical devices We certify that the production quality system conforms to the relevant provisions of the aforementioned legislation and the result entitles the organization to use the CE 0473 marking on those products listed above Applied Standards BS 1041 EN ISO 10079 3 EN ISO 14971 ISO 15223 1 Notified Body AMTac Certification Services Limited C 0473 Address Davy Avenue Knowlhill Milton Keynes 8NL UK Certification Registration No s 1126 CE Date of Expiry 03 August 2017 Devices already manufactured S N traceability Device History Records Validity of DOC 04 August 2012 to Date of Expiry Manufacture Representative Quality Manager Position Quality Systems ISO Representative Date of Issue 04 August 2012 Tell us how we are doing Visit us at www precisionmedical com 1949 Rev19 12 14 10M Printed in USA
4. S 1 To assemble perform the DISASSEMBLY INSTRUCTIONS in reverse order Ensure the Selector Assembly is inserted with the groove in the 12 o clock position e Ensure tabs and slots on various components are properly aligned and engaged when reassembling Lubricate all O rings and cavities with Vacuum grease part 1775 supplied in the Vacuum Regulator Repair Kit Repeat steps 1 through 3 of OPERATING INSTRUCTIONS Prior to returning Vacuum Regulator to service verify accuracy of gauge ih ny VACUUM REGULATOR CLEANING ILLUSTRATION Cleaning Decontamination Instructions on page 8 Working Vacuum Regulator Vacuum To Be Cleaned Regulator Suction Tubing ee Suction Lf Tubing Q Patient Vacuum Port Port Cold Suction Disinfection Collection Sterilization Canister Solution ACAUTION DO NOT autoclave or immerse in liquid This will cause damage to the Vacuum Regulator and will void the warranty e 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 e This Vacuum Regulator contains magnetic ferrous material that may affect the results of an MRI e Be sure all connections are tight and leak free VACUUM REGULATOR CONTINUOUS INTERMITTENT 7
5. USER M ANUAL VACUUM REGULATOR CONTINUOUS INTERMITTENT MODEL SERIES PM3300 snow PM3400 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 Northampton PA 18067 USA ISO 13485 Certified Tel 001 610 262 6090 Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING INSPECTION asi ceciceccssoctivaircunetbvincnaadeiancedasanenguebis 2 2 READ ALL INSTRUCTIONS BEFORE USING eneee 2 EXPLANATION OF ABBREVIATIONS 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 SPECIFICATIONS Persinin nanninannan aaae A AEE aai 3 OPERATING INSTRUC TIONS nsis 4 PARTS DESCRIP MON 5 PARTS 5 6 DISASSEMBLY 5 5 6 ASSEMBLY 5 6 VACUUM REGULATOR CLEANING 7 CLEANING DECONTAMINATION siciicieccsadcsntineresesninerniadtertennster
6. and eight 8 seconds OFF Reference only 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 AA Digital Vacuum Gauge Models ONLY Specifications are subject to change without prior notice VACUUM REGULATOR CONTINUOUS INTERMITTENT 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 float shutoff e Gauges operate independently if the digital gauge fails the analog gauge will still function 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 COUNTERCLOCKWISE B INT MODE Vacuum cycles ON and OFF 1 Turn the Selector Knob to the REG position to select desired vacuum level 2 Turn the Selector Knob to the INT position NOTE Intermittent cycles starts in the OFF phase therefore
7. lace Snubber 2 Replace Regulator Module 3 Replace Gauge Vacuum Regulator erratic 1 Dirty Regulator Module 2 Defective Regulator Module Disassemble amp clean Lubricate O ring 2 Replace Module Stiff movement of Selector Knob 1 Dirty Regulator Module and or Selector Module Disassemble amp clean Lubricate O rings No Intermittent INT cycle 1 Improper mode selected 2 Defective Timing Module 1 Turn Selector Knob to INT mode 2 Replace Timing Module No digital display Dead Battery Replace Battery VACUUM REGULATOR CONTINUOUS INTERMITTENT 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 rep
8. n Medical Inc All returns must be packaged in sealed 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 oak w Manuals available on our Website www precisionmedical com ih nh VACUUM REGULATOR 8 CONTINUOUS INTERMITTENT DISPOSAL INSTRUCTIONS Dispose of the Vacuum Regulator in accordance with the local regulations Please Recycle 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 1 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 Clogged Regulator Disassemble amp clean Vacuum at bottom port No reading on gauge when port is blocked Defective Gauge Replace Gauge Gauge will not return to zero Clogged Snubber 2 Damaged Regulator Module 3 Defective Gauge 1 Rep
9. resentative 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 exclusive 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 fulfillment 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 amp REGULATOR 1 CONTINUOUS INTERMITTENT DECLARATION OF CONFORMITY Precision Meidcal Inc 300 Held Drive Northampton PA 18067 Emergo Europe European Office Motenstraat 15 2513 BH The Hague 0473 The Netherlands Phone 31 0 70 345
10. ring Washer 1614 9 Case Assembly 1827 10 Regulator Module Assembly 1567 505962 1567 11 Set Screw 1391 12 Control Knob Assembly 502100 13 Timing Module 502103 14 Rear Case 1831 HV MODELS ONLY PM3300HV VACUUM REGULATOR CONTINUOUS INTERMITTENT 5 REPAIR KITS Analog Part Digital Part PM3300 PM3300D Vac Reg RK6300 RK6300D PM3300HV PM3300DHV Vac Reg RK6300HV RK6300DHV PM3300E PM3300DE Vac Reg RK6300E RK6300DE PM3300EHV PM3300DEHV Vac Reg RK6300EHV RK6300DEHV PM3400 PM3400D Vac Reg RK6400 RK6400D PM3400E PM3400DE Vac Reg RK6400E RK6400DE DISASSEMBLY INSTRUCTIONS N WwW 8 9 Reference PARTS DESCRIPTION Loosen the Set Screw Item 11 in Selector Knob 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 product Remove the Rear Case Item 14 by pulling away from product Remove screws Item 2 from the top of the Timing Module Remove the Timing Module Item 13 by pulling away from the Housing Assembly Item 1 Separate the Case Assembly Item 9 by pulling it away from the Housing Assembly Item 1 Remove the Selector Assembly Item 6 by pulling it away from the Housing Assembly Item 1 Remove the Gauge Assembly Item 3 ASSEMBLY INSTRUCTION
11. s 8 8 RETURNS 8 DISPOSAL INS TRUC HONG wiscsctia cian ns neras 9 9 LIMITED WARRANTY isccissactocetiesctenntssthceesessncienateucctaupignineseiypieces 10 DECLARATION OF GONE OR MIN Y tis 11 VACUUM REGULATOR 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 8 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 I min Liters Per Minute mmHg Millimeters of Mercury inHg Inches of Mercury kPa Kilopascal SAFETY INFORMATION WARNINGS AND CAUTIONS Indicates a potentially hazardous situation which if AWARNING 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 CAUTION Used without the safety alert symbol indicates a potentially ha
12. zardous situation which if not avoided may result in property damage is CONSULT ACCOMPANYING DOCUMENTS There are no components in this product made with natural rubber latex 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 e Only personnel instructed and trained in its use should operate this Vacuum Regulator n Ai ny SPECIFICATIONS GAUGE RANGE PM3300 0 200 mmHg Full Vacuum PM3300E 0 200 mmHg 0 26 kPa PM3300EHV 0 300 mmHg 0 40 kPa PM3300HV 0 300 mmHg Max Vacuum PM3400 0 150 mmHg PM3400E 0 150 mmHg 0 20 kPa Counterclockwise direction 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 REG Regulated provides an adjustable continuous vacuum level OFF Vacuum INT Intermittent provides an adjustable vacuum level that cycles between ON and OFF FLOW Models Mode Max Flow 51 l min REG PM3400 50 l min MAXIMUM FLOW IS OBTAINED WITH A VACUUM SOURCE OF 21 Hg 71 1 kPa MAXIMUM VACUUM PM3300 REG Mode Full Vac 396 mmHg 53 kPa PM3300HV REG Mode Max Vac 396 mmHg 53 kPa PM3400 Restricted to 170 mmHg 10 mmHg 1 3 kPa INTERMITTENT CYCLE TIME Factory set at sixteen 16 seconds ON
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