USER MANUAL - Precision Medical
Contents
1. USER MANUAL VACUUM REGULATOR PEDIATRIC INTERMITTENT MODEL SERIES PM3300 shown 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 Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING J INSPECTION ient rante ea bp aae a um 2 INTENDED USE sienna eer aa er eee 2 READ ALL INSTRUCTIONS BEFORE USING ccecce 2 EXPLANATION OF ABBREVIATIONS em 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 SPECIFICATIONS csi baikcodtent Obi da Roo eed a aaa eed 3 OPERATING INSTRUCTIONS x sies sub un enu rabb tt neon uS peo 4 PARTS DESCRIPTION ioi stevie atececatoe eannan 5 PARTS HUS Wags D 5 az WSUS sees sa a a A 6 DISASSEMBLY INSTRUG TIONS noatra x Rien 6 ASSEMBLY INSTRUCTIONS o eeocdesqude uti dot etuidtates io tuque 6 VACUUM REGULATOR CLEANING ILLUSTRATION 7 CLEANING DECONTAMINATION 8 MAINTENANCE sisii iaai 8 RETURN m 8 DISPOSAL INSTRUCTIONS ttis itt etapas PETRUS RU as E SRM ERE IU it 9 TROUBLESHOOTING cieccconidtccutccn iaaa ian eiaa in beu tes 9 LIMITED WARRANTY acci eiece trien uu merid extr nonien vei vn setis ent 10 DECLARATION OF CONFORMITY eeen 11 VACUUM REGULATOR RECEIVING INSPECTION2. 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 rightto 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 Manufacturer Authorized European Representative Product Model s MDD Class Classification criteria Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Emergo Europe European Office Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Vacuum Regulators PM3300E PMM3300EHV PM3300DE PM3300DEHV PM3400E PM3
3. 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 a 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 Ipm 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 ACAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury CAUTION Used without the safety alert symbol indicates a potentially hazardous situation which if not avoided may result in property damage a CONSULT ACCOMPANYING DOCUMENTS Symbol indicates the device complies with the requirements of Directive 93 42 EEC concerning 5 medical devices and all applicable International Standards On CE marked Devices ONLY AWARNING DO NOT use this Vacuum Regulator for anything other t
4. its previously regulated setting Full Line Vacuum is present between settings 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 VACUUM REGULATOR ULATOR PARTS DESCRIPTION ACAUTION 3 Analog 2 QUANTITY 6 PLACES 7j Missing or illegible labels must be replaced contact Precision Medical Inc 3 Digital PM3400 PM3400E ONLY 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 Digital Assembly HV 505244 0 200 mmHg 505392 0 300 mmHg 505391 0 150 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 Spring 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 502268 14 Rear Case 1831 HV MODELS ONLY PM3300HV VACUUM REGULATOR PE
5. 400DE lla Clause 1 2 Rule 2 of Annex IX of MDD As delivered the object of the declaration described above is in conformity with the requirements of MDD 93 42 EEC Annex II 3 and the following documents BS EN 1041 EN 980 EN ISO 10079 3 EN ISO 14971 Notified Body T V Rheinland Product Safety GmbH C 0197 Certificate No HD60019110 0001 ISO 13485 Certified 0197 1949 Rev15 03 28 11 M Printed in USA
6. DIATRIC INTERMITTENT 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 Do BR OO 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 INSTRUCTIONS 1 To assemble perform the DISASSEMBLY INSTRUCTIONS in reverse order NOTE Ensure the Selector Assembly is inserted with the groove in the 12 o clock position Ensure tabs and slots on various components are properly aligned and engaged when reassembling Lub
7. Humidity Max 95 Noncondensing Battery 3 Volt Lithium 1 2 AA Specifications are subject to change without prior notice VACUUM REGULATOR PEDIATRIC INTERMITTENT 3 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 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 a delay occurs before the intermittent cycle begins 3 Turn the Selector Knob to the OFF position to turn the Regulator off AWARNING ALWAYS confirm vacuum setting prior to performing procedure When turning the Vacuum Regulator to REG or INT from any position the vacuum level will return to
8. ective Regulator Module 2 Replace Module Stiff movement of 1 Dirty Regulator Module 1 Disassemble amp clean Selector Knob and or Selector Module Lubricate O rings No Intermittent INT 1 Improper mode selected 1 Turn Selector Knob to cycle INT mode 2 Defective Timing Module 2 Replace Timing Module No digital display Dead Battery Replace Battery VACUUM REGULATOR 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
9. er to Precision Medical Inc Return Policy available on the Internet www precisionmedical com Manuals available on our website www precisionmedical com VACUUM REGULATOR oa kw 8 DISPOSAL INSTRUCTIONS Dispose of the Vacuum Regulator in accordance with the local regulations X Please Recycle Ve 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 Loose connection No vacuum to Regulator Clogged vacuum Port 2 3 a Turn selector knob b Adjust Regulator knob Tighten connection Connect to a known working vacuum source Disassemble amp clean No vacuum at bottom 1 port gauge showing vacuum Clogged Regulator Disassemble amp clean Vacuum at bottom port 1 No reading on gauge when port is blocked Defective Gauge Replace Gauge Gauge will not return Clogged Snubber Replace Snubber to zero 2 Damaged Regulator 2 Replace Regulator Module Module 3 Defective Gauge 3 Replace Gauge Vacuum Regulator 1 Dirty Regulator Module 1 Disassemble amp clean erratic Lubricate O ring 2 Def
10. han 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 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 x 596 of MAX Digital Analog Dual Gauge Digital Display x 196 of Full Scale Analog Gauge x 596 of MAX within ref Indicator VACUUM PORTS 1 8 NPT Female MODES REG Regulated provides an adjustable continuous vacuum level OFF No Vacuum INT Intermittent provides an adjustable vacuum level that cycles between ON and OFF Models Mode Max Flow 51 LPM REG PM3400 50 LPM 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 x 10 mmHg 1 3 kPa INTERMITTENT CYCLE TIME Factory set at sixteen 16 seconds ON and eight 8 seconds OFF 2 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
11. lator 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 Turn the Vacuum Regulator to be cleaned to the INT mode 9 Allow remaining cold disinfection sterilization solution to pass through and collect in Suction Canister 10 Set working Vacuum Regulator to its maximum vacuum setting 11 Thoroughly dry the internal components by drawing maximum vacuum through the Regulator to be cleaned for at least 30 seconds in both REG and INT modes 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 Precision 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 Ref
12. ricate 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 VACUUM REGULATOR VACUUM REGULATOR CLEANING ILLUSTRATION Cleaning Decontamination Instructions on page 8 Working Vacuum Regulator Vacuum To Be Cleaned Regulator Suction Tubing AN 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 f Vacuum Regulator becomes internally contaminated warranty is voided DO NOT send back to Precision Medical Inc for repair Follow your facilities contaminated equipment protocol This Vacuum Regulator contains magnetic ferrous material that may affect the results of an MRI Be sure all connections are tight and leak free VACUUM REGULATOR DIATRIC INTERMITTENT 7 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 Regu
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