USER MANUAL - Precision Medical
Contents
1. EASYGO VAC ASPIRATOR ae PM66 Series PM66Li Shown i SAVE THESE INSTRUCTIONS For the most current manual revision please visit our Website www precisionmedical com PRECISIONG MEDICAL R 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 ISO 13485 Certified CONTENTS Free oe TING INS IN oases te erect scrapes bites nated ecco ogc mes ieee peoeceecseseneeeenet 1 INTENDED U Serna ee re erat ete ae ea et ee eee ee eee 1 READ ALL INSTRUCTIONS BEFORE USING ooo sgecic chet occ ccdsesccleseccscacssenceacseteedsecensians 1 EXPLANATION OF ABBREVIATIONS ccccceccccssecceseeeeseeceeceeeeeceeeeseeessaeessaeees 1 SAFETY INFORMATION WARNINGS AND CAUTIONS c cccceeseeeeseeeeeeeeeeeens 2 SFECIFRICATONS een eer en ee nee ee eee eer eee ene ee eee ee eee 4 COMPONENT IDENT IFICATION a a occas reeset pees tee cece erect ee 5 OPERATING INSTRUCTIONG cc cccccccsececeeseeesseeeceaseeseasesseueesesseeseaseeseaseeeeaeeress 7 MAINTENANCE gece sccicccisesstcneciesccternncuabacivossteeacsesieleadedsduaetedsecdecwonerieiaeecticussehePohondeeseessic 9 CANISTER REMOVAL ASSEMBLY BOO GC LIS 0 OS Al asses A E he ccna ons leant ananeesah conse eeceencsecseceuscasisiaes 10 120060 Reusable Seen nce ee ee ee ee eee eee aero cents 11 INLINE FILTER REPLACEMENT cc eee wc cere eet ee ea eeieescunesneece ieee 12 RETURNS sesse oers aeneae Ae EOE oe eee cle Soe wees eO ESRR2. Push to Activate Battery Battery Low Battery Charging Battery Full ON for part of equipment Single Use 3 OCRE OO K OO O Follow Instructions for Use General Mandatory Action Sign Manufacture Model Number Class I Equipment DO NOT disassemble Degree of protection against ingress of solids and or liquids Alternating Current Direct Current DC power connection Positive Center OFF for part of equipment EASY GO VAC The PM66 Series Aspirators meet the requirements of IEC 60601 1 2 and are considered safe from producing electromagnetic interference with other devices when used normally in accordance with their intended use Should the aspirator cause any interference try repositioning it or moving it to another location DANGER To reduce the risk of Electrocution Always unplug the Aspirator after using except when battery is being recharged DO NOT use place or store the Aspirator where it can fall or be pulled into a tub sink water or other liquids Unplug from wall immediately DO NOT attempt to repair the Aspirator Any attempt could result in electrical shock Caution must be exercised when operating the Aspirator where oxygen is being administered The Aspirator is not suitable for use in an enriched environment of flammable anesthetic mixture with air oxygen or nitrous oxide To reduce risk of burns electrocution fire or injury to persons Close supervision is n
3. Auto DC Power Cord 507213 Hydrophobic Filter will provide higher level of protection stopping the egress of liquid into the device if canister overfill protection should fail nh PI a EASY GOK VAC 14 ASPIRATOR DECLARATION OF CONFORMITY Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Emergo Europe European Office 0473 Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 PM66AC R PM66AC D PM66S R PM66S D PM66LI R amp PM66LI D Classification Ila 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 ll 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 EN 1041 EN 60601 1 EN 60601 1 2 EN ISO 10079 1 EN ISO 14971 ISO 15223 1 ISO 13485 Notified Body eres aac Certification Services Limited C 0473 Address Davy Avenue Knowlhill Milton Keynes MKS 8NL UK Certification Registration No s 1126 A CE Date of Expiry 03
4. 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 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that Easy Go Vac Aspirator the Product and the following component parts thereof will be free of defects in workmanship and or material for the following periods Easy Go Vac Aspirator Two 2 years from shipment Battery Six 6 months from 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 representatives 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 THI
5. Contact your local waste Management for disposal of Electronic Equipment J a TROUBLESHOOTING If the Aspirator fails to function consult this Troubleshooting section If the problem cannot be corrected consult your Provider There are no user serviceable parts inside this device DO NOT open case Problem Probable Cause Remedy Aspirator will 1 On Off Switch in OFF On Off Switch to ON not operate on position position battery 2 Battery not charged Recharge battery Low battery light on elf battery will not charge contact your Provider Aspirator will not 1 On Off Switch in OFF On Off Switch to ON operate when position position connected to AC 2 AC Power Cord not Check connection at both Power Source connected AC Power Source and Aspirator Continued on next page EASY GO VAC a 13 TROUBLESHOOTING continued Problem Aspirator will not operate when connected to Auto DC Power Cord Battery will not charge Unable to achieve desired vacuum setting Inlet Filter becomes blocked by fluid Hydrophobic only Aspirator stops running power switch ON battery or AC power applied position Car not turned on Auto DC Power Cord not connected properly Defective auto power port receptacle Defective Auto DC Power Cord Not connected to AC power source Defective battery Filter not connected properly Filter not installed corre
6. ESES ERESSE E 13 DISPOSAL INS TRUC ONS ss secccocscetateestewecciesedescecenestinich sacnetei ence osenueenrestrenceeiec eu 13 TROUBLESHOOTING ieee eee en neon eeseer ale nesta Mere enn earner eee iain A 13 ACCESSORY REPLACEMENT Mc 2 Boe eee eee 14 DECLARATION OF CONFORMITY essence sco cnencvsverceenteecs onde Seinse ces sucecsetoccdsandeenecvaxdendeec 15 LIMITED WARRANTY areee annette meee Meee a aeaa tee ee re a emir a eh ane ern heen eee eee 15 RECEIVING INSPECTION Remove the Precision Medical Inc Easy Go Vac Aspirator from packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE The Easy Go VacAspirator provides a portable AC DC powered medical vacuum source It is intended for use in the homecare healthcare environments Q Only use this Aspirator for its Intended Use READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the Easy Go Vac Aspirator The Easy Go Vac Aspirator is to be used only by trained professional caregivers in a home or hospital environment The Easy Go Vac Aspirator is to be used only by adults capable of reading and understanding the Instructions of Use written in the appropriate language This manual is provided for your training safety and to prevent damage to the Aspirator Ifyou do notunderstand this manual DO NOT USE the Aspirator and contact your Provider EXPLANATION OF ABBREVIATIONS mmHg Millimete
7. S 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 K yh h Mii My EASY GO ASPIRATOR 507099rev1 1 15 m Printed in USA
8. and contact your equipment provider Bacteria Filter will not stop liquid from entering the device OPERATING INSTRUCTIONS 1 Charge Device Plug into wall outlet co Full charge 2 to 3 hrs Ld e v v PM66Li and PM66S models only 3 Connect suction tubing to canister Push together 5 Block suction tubing Block end to set vacuum level vasreopag _ 2 Connect to power source for external power operation 4 Power ON Push button TF as Battery Ne oo 6 Adjust knob to desired vacuum level on gauge Wl OPERATING INSTRUCTIONS continued 7 Perform Procedure 8 Power OFF when procedure completed Push button 7 ala Connect patient suction attachment perform procedure d OFF ff 9 lt j Battery Level CUO _ emmy A CAUTION Verify battery charge if equipped prior to use Charging Light is on when Aspirator is plugged in and is in the OFF O position only If automatic shut off occurs during battery operation the Aspirator cannot be restarted until the battery has been recharged or until the Aspirator is connected to either of the external power source options AC or DC A WARNING Operating Aspirator after Amber Low Battery Light has been on continuously will cause automatic shut down Device in carry bag nh PI CLEANING MAINTENANCE A WARNING e Turn the Aspirator OFF
9. and disconnect from any external power source before cleaning e DO NOT clean the Aspirator with Alcohol Acetone or other solvents CAUTION e Tubing is single patient use only DO NOT clean Q e Canister is single patient use only MAINTENANCE Vacuum Flow verification should be checked by the device provider as necessary Recommended annually or between patients Cleaning for Exterior Components 1 Disconnect the Aspirator from power source and other connections before cleaning 2 Use a cloth or sponge dampened with mild soap and water 3 Wipe dry with a clean cloth or paper towel 4 Store the Aspirator in a clean area free from grease oil and other sources of contamination 1200cc canister reusable can be cleaned with a mild detergent or placed on top rack of dishwasher For institutional cleaning Exterior Hospital approved quaternary cleaner i e Sporociden Reusable canister Cydex or equivalent EASY GO VAC CANISTER REMOVAL ASSEMBLY 800cc Disposable 1 Push tabs to release canister 2 Pull canister away from device 6 Align canister assembly with inlet port and locking tabs with openings on device EASY GO VAC 10 CANISTER REMOVAL ASSEMBLY 1200cc Reusable 1 Grasp filter and pull apart 2 Tilt off base to remove 3 Remove lid empty amp clean 4 Place lid on canister INLINE FILTER REPLACEMENT e When installing inline filter be sure the side that has small nubs and sa
10. ctly Suction Canister not connected properly Defective Suction Canister Defective Aspirator Suction Tubing Leaks Collection Canister overflow mechanism failed Device overheating Probable Cause Remedy On Off Switch in OFF On Off Switch to ON position Turn on car to activate it s DC outlet Check connections at both ends of cord Connect to a known working auto power port Contact your Provider Connect to AC power source 2 Contact your Provider oO N NO ooas Confirm and tighten connections Confirm orientation of filter Confirm and tighten connections Replace Suction Canister Contact your Provider Replace Suction Tubing Replace Collection Canister Replace Filter Power OFF device and allow cooling Ensure device has adequate ventilation Ensure vents are not blocked ACCESSORY REPLACEMENT PARTS ap Only use accessories designed for use with this Aspirator e Use tubing intended for suction only e Use Collection Canisters designed for use with this Aspirator only e Use Precision Medical Inlet Filter External AC amp DC Power Cord amp Carry Bag Only Description Part Inlet Filter Hydrophobic 506851 Inlet Filter Bacterial 507754 800cc Canister Case 10 ea 502519 10 800cc Inlet Adapter Kit 507521 1200cc Canister 507522 Patient Suction Tubing 1955 Carry Bag 507263 AC Power Cord 506961
11. ecessary when this Aspirator is used by on or near children or patients with special needs Use this Aspirator only for its Intended Use as described in this manual Use of accessories and connecting parts not designed for this Aspirator may affect performance and or cause damage to the device DO NOT use if the Aspirator has been damaged DO NOT clean the Aspirator with harsh or flammable chemicals If the Aspirator tubing becomes occluded against patient s tissue powering off the device may not release tubing No modifications to this device are allowed The negative pressure of the unit must be checked by occluding the end of the suction tubing before attaching it to the suction catheter and prior to each suctioning event Suction pressure should be set as low as possible to be effective The connection of high vacuum high flow devices to low flow accessories has the potential to harm the patient A CAUTION e DO NOT store or operate the Aspirator outside the specified environmental conditions e Patients with special needs may require assistance to operate the Aspirator e Incorrect accessories connected to this device may affect the device flow performance e DO NOT allow Aspirator to exceed Operating or Storage Temperature specifications EASY GO VAC SPECIFICATIONS For technical specifications contact Precision Medical Inc or visit www precisionmedical com Suction Canister 800mI 1200ml Max Volume Lid
12. ector a PME6LI R Vacuum Filter Vacuum Control Knob Gauge On Off Patient Switch Port i Battery ee m Level Indicator 800ml Suction Canister Built i rfill Built in overfi Charge rotection device j Status Indicator Power Source External DC Indicator Connector if equipped I e Exhaust Vents PM66Li D AC Connector j EASY GO VAC PM66AC AC ONLY PM66S Sealed Lead Acid ab A C Battery D C Power Source CA Ca os Low Charging Full Charge Status ASPIRATOR High Vacuum High Flow Power Source When light is GREEN the indicated power source is being used Charge Status if equipped LOW The power switch is ON AC not plugged in and light is AMBER the Aspirator Internal Battery requires charging CHARGING The power switch is OFF AC is plugged in and light is AMBER the Aspirator is in the charging process FULL The power switch is OFF AC is plugged in and light is GREEN the Aspirator Battery is fully charged Battery Level Li model only Push to check battery level GREEN Level is Good AMBER Level is getting Low RED Recharge required 1 uh EASY GO VAC ZA CAUTION DO NOT run the Aspirator without the Inline Filter using aspirator without filter will void the warranty Do not remove or damage canister overfill protection device If liquid and or solid material has been drawn into the device immediately stop using the device
13. has a float shut off valve that protects the Aspirator from overfill Vacuum is not to exceed 25 inHg 635 mmHg Patient Tubing 1 4 in ID Non Conductive PVC tubing 6 ft long with 1 4 in 3 8 in ID female connectors Inlet Filter Inline Bacterial Filter included Inline Hydrophobic Filter optional Operating Vacuum Range 2 to 219 inHg 51 to 2483 mmHg Electrical Car Charger DC 12 Volts 1 8 Amps Household Current AC 100 240 Volts 50 60 Hz 0 35 0 80 Amps 60 Watts Internal Battery Type Battery PM66S 12 Volt Sealed Lead Acid Battery PM66LIi 14 8 Volt 4 cell Lithium lon Operating Temperature Range 0 F to 122 F 18 C to 50 C Storage Transport Requirements Temperature Range 40 F to 160 F 40 C to 71 C Maximum Humidity 95 Noncondensing Duty Cycle 15 Min ON 15 Min OFF within a 2 Hour cycle Run Time approx 1 hour using internal battery Charge Time 2 3 hours Specifications are subject to change without prior notice I nh 0 COMPONENT IDENTIFICATION A CAUTION If for any reason any label becomes illegible or lost contact Precision Medical Inc Patient Vacuum Vacuum Control Knob Port Gauge N On Off Switch Filter 1200ml Suction Canister eee Built in overfill indicator protection device Charge Status Indicator Power Source Indicator D External DC Connector if equipped A Exhaust Vents AC Conn
14. rs of Mercury min Liters per Minute inHg Inches of Mercury SAFETY INFORMATION WARNINGS AND CAUTIONS DANGER Z WARNING Z CAUTION CAUTION Cy iA a N oe a oe rf a WD ONLY xX m I A N R Indicates an imminently hazardous situation which if not avoided will result in death or serious injury Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury Used without the safety alert symbol indicates a potentially hazardous situation which if not avoided may result in property damage PM66 SERIES WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2012 3 1 ed CAN CSAC22 2 No 60601 1 2014 62NA Caution U S Federal Law restricts this device to sale by or on the order of a physician This device may contain electrical components that are hazardous to the environment DO NOT dispose device into standard trash Contact your local waste Management for disposal of Electronic Equipment Symbol indicates the device complies with the requirements of Directive 93 42 EEC concerning medical devices and all applicable International Standards gt HLR R L pg eo RUL Operating Instructions General Warning Sign Date of manufacture Serial Number Type BF applied part
15. ys OUT is facing toward inlet port on device e Filter cannot be cleaned If it becomes contaminated or clogged it must be replaced 800cc Disposable Canister Inlet Adaptor Kit Slightly twist f F ur J t OUT toward device side with nubs a Inlet Port Canister Adaptor To remove filter Pull apart To install Push together 4 ONN R EASY GO VAC RETURNS Returned products require a Returned Goods Authorization RGA number contact Precision Medical Inc All returns must be properly packaged to prevent shipping 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 Precision Medical will NOT repair contaminated devices biohazard DISPOSAL INSTRUCTIONS Dispose of Biohazard waste as described by your Healthcare Professional or Healthcare Facility protocol A WARNING e The Aspirator may contain an internal battery Batteries contain materials which can contaminate the environment when improperly disposed of Dispose of the Aspirator in accordance with local regulations If Aspirator is used for treatment of infectious disease consult your Physician or Healthcare Professional for recommended procedures for proper disposal This device may contain electrical components that are hazardous to the environment DO NOT dispose device into standard trash
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