USER MANUAL
Contents
1. USER MANUAL Continuous Subglottic Suction Regulator ACAUTION PRECISIONG MEDICAL 300 Held Drive Model No PM9100 Series shown PUSH 4 TO CLEAR f 40 50 e 30 20 GU C U 60 iu mmHg Precision MEDICAL 7 FLOW INDICATOR SAVE THESE INSTRUCTIONS Federal USA law restricts this device to sale by or on the order of a physician Your local distributor N Medical Dynamics Northampton PA 18067 USA TECHNOLOGY OF THE FUTURE TODAY 866 624 3952 www thinkMDl net WWw precisionmeq CONTENTS RECEIVING INSPECTION A 2 INTENDED SE 2 READ ALL INSTRUCTIONS BEFORE USING 2 EXPLANATION OF ABBREVIATIONS 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 INSTALLATION gees Mei eRe 3 SPECIFICATION X 3 COMPONENT 440 22 5 OPERATING 8 2 2 220 6 CLEANING DECONTAMINATION 7 8 PRE EE 9 DISPOSAL INSTRUGTIONS EE 9 TROUBLESHOOTING piter tiae enin es 9 LIMITED WARRANTY AND LIMITATION OF LIABILITY 10 PM9100 Continuous Subglottic Suction Regulator RECEIVING INSPECTION Remove the Precision Medical Inc PM9100 Continuous Subglottic Suction Regulator from the packaging and inspect for da2. cision Medical Inc All returns mustbe 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 DISPOSAL INSTRUCTIONS Dispose of the Continuous Subglottic Suction Regulator in accordance with the local regulations Please Recycle VS AWARNING Product should be cleaned before being disposed of Potential for Biohazard TROUBLESHOOTING If the Suction Regulator fails to function consult the Troubleshooting Table If problem cannot be solved consult your Provider Problem Probable Cause Remedy No vacuum at bottom port float ball not visible Regulator turned OFF Loose connection Subglottic port tube clogged Collection Container full No vacuum to Regulator Clogged vacuum Port Adjust Vacuum Control Regulator knob Tighten connection Refer to manufacturers recommendation to unclog Replace Container Connect to a known working vacuum source Disassemble and clean Float Ball will not return to No Flow position Float ball wet Defective flow indicator Set vacuum level to maximum and allow to dry Contact Precision Medical Inc for repair Vacuum Regulator erratic Dirty Regulator Module Defective Regulator Module Clean Regulator per Cleaning Instructions Contact Precision Medical I
3. ection 1 4 Hose Barb with Flow Indicator Operation OFF No Vacuum REG Regulated provides an adjustable continuous vacuum level PUSH TO CLEAR Temporarily increases vacuum level to line Flow Modei Mode MaxFou PM9100 REG 13 Ipm 20 mmHg up to 85 mmHg 20 85 mmHg 37 lpm MAX of 85 mmHg Push to Clear 54 Ipm MAXIMUM FLOW IS MEASURED A VACUUM SOURCE OF 21 inHg Maximum Vacuum PM9100 REG Mode 78 85 mmHg 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 to 60 C Humidity 95 Noncondensing Specifications are subject to change without prior notice PM9100 Continuous 4 Subglottic Suction Regulator COMPONENT IDENTIFICATION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc PUSH TO CLEAR button Be is Vacuum Control Knob PUSH 4 TO CLEAR i 40 Vacuum 50 Connection 30 Back of Unit 20 CU AY Uy d Precision MEDICAL FLOW w ae Patient Connection mmHg NO FLOW PM9100 Continuous Subglottic Suction Regulator 5 OPERATING INSTRUCTIONS CAUTION Inspect the Continuous Subglottic Suction Regulator for visual damage DO NOT USE if damaged NOTE Overflow protection m
4. he 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 FORAPARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED 5 09 55 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 gt 55 lt 3 55 3 lt 22 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 PM9100 Continuous 10 Subglottic Suction Regulator PRECISION MEDICAL Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Toll Free Tel 800 272 7285 Toll Free Fax 800 352 1240 Tel 001 610 262 6090 Fax 001 610 262 6080 www precisionmedical com ISO 13485 Certified 506477 E 07 16 10 PRINTED USA
5. mage If there is any damage DO NOT USE and contact your Provider INTENDED USE The PM9100 Continuous Subglottic Suction Regulator is intended to control the amount of vacuum from a central vacuum system that is to be delivered to devices designed to continuously aspirate subglottic secretions READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the PM9100 Continuous Subglottic Suction Regulator This is provided for your safety and to prevent damage to the Continuous Subglottic Suction Regulator If you do not understand this manual DO NOT USE the Continuous Subglottic Suction Regulator and contact your Provider EXPLANATION OF ABBREVIATIONS Ipm Liters Per Minute mmHg Millimeters of Mercury inHg Inches of Mercury 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 notavoided may resultin 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 zs CONSULT ACCOMPANYING DOCUMENTS PM9100 Continuous 2 Subglottic Suction Regulator AWARNING DO NOT use this Continuous Subglottic Suction Regulator for anything other than its Intended Use Personal injury and or damage to Reg
6. nc for repair Stiff movement of Vacuum Control Knob Dirty Regulator Module Clean Regulator per Cleaning Instructions Set Vacuum Level is not accurate Dirty Regulator Module Filter is clogged Clean Regulator per Cleaning Instructions Replace Filter Replacement Filter 10 pack Part 1396 10 PM9100 Continuous Subglottic Suction Regulator 9 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that Continuous Subglottic Suction Regulator the Product will be free of defects in workmanship and or material for the following period SSS SS 22 55 SS 2 5 Two 2 years from shipment 222 5 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 25 The representatives Precision Medical Inc or any retailers are not authorized to make oral warranties about the merchandise de scribed in this contract and any such statements shall not be relied upon and are not part of t
7. nnected to Disinfection Sterilization Solution 2 amp Standard Vacuum Regulator Regulator Fitting Patient g Vacuum Port Port L J Suction Collection Canister Cleaning of Subglottic Suction Regulator PM9100 Continuous Subglottic Suction Regulator AWARNING DO NOT autoclave or immerse in liquid This will cause damage to the Suction 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 Suction Regulator contains magnetic ferrous material that may affect the results of an MRI Besure all connections are tight and leak free 1 Attach a working Vacuum Regulator with a continuous regulated mode to a minimum vacuum level of 200 mmHg 2 Mix cold disinfection sterilization solution according to its manufacturers directions 3 Connect tubing as shown in CLEANING DECONTAMINATION on previous page 4 Adjust the Suction Regulator s to be cleaned on the continuous regulated mode 5 Adjust the vacuum to a minimum of 60 mmHg 6 Depress PUSH TO CLEAR button and hold for 10 seconds 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 sterilizati
8. on solution for the desired level of disinfection or sterilization 8 Set vacuum control knob to zero and clamp off suction tubing so solution does not flow out 9 Allow cold disinfection solution to remain inside regulator for recommended time to achieve desired level of disinfection Rinse Sterile or Potable Water 10 Adjust the Suction Regulator s to be cleaned to a minimum of 60 mmHg 11 Allow remaining cold disinfection sterilization solution to pass through and collect in Suction Canister occasionally depressing and holding the PUSH TO CLEAR button Repeat rinse according to Disinfectant Manufacturers Recommendations 12 Thoroughly dry the internal components by drawing maximum vacuum through the Suction Regulator to be cleaned for at least 30 seconds Note f it is not possible to pass cold disinfection sterilization solution through the Suction Regulator then the passageways are totally blocked and DISASSEMBLY of the Suction Regulator is required Please contact your Precision Medical Inc Sales Representative Be sure to follow your facility s Biohazard protocol MAINTENANCE Before each use visually inspect Continuous Subglottic Suction Regulator for any sign of damage DO NOT USE if damaged Replace the filter every 1 year or as necessary to prevent clogging PM9100 Continuous 8 Subglottic Suction Regulator RETURNS Returned products require a Returned Goods Authorization RGA Number contact Pre
9. ton should never be depressed for longer than 15 seconds as injury to the patient may occur The PM9100 Subglottic Suction Regulator must be serviced if the PUSH TO CLEAR button fails to return to its original position Depress PUSH TO CLEAR button for 1 5 seconds at a time and observe flow indicator to determine if clog is cleared from port or tube If blockage is not removed follow device manufacturers recommendations for clearing the subglottic port or tube Turn the Vacuum Control Knob to the OFF position to turn the Regulator off Knob must be turned counterclockwise until knob reaches stop and ball falls ACAUTION DO NOT operate the PM9100 when the collection canister is full This may cause loss of vacuum and damage to the Suction Regulator This will void the warranty PM9100 Continuous 6 Subglottic Suction Regulator CLEANING DECONTAMINATION PM9100 Suction Regulator EEL Regulator Fitting Ji Patient m 1 Vacuum Port Port Lj Cold Suction Disinfection Collection Sterilization Canister Solution As needed Working Vacuum Regulator Set 200mmHg Suction Tubing y Vacuum Regulator Suction Tubing connected to Cleaning of Subglottic Suction Regulator PM9100 Suction Regulator Working Vacuum Regulator Set 200mmHg Vacuum Regulator Suction Tubing Suction Tubing co
10. ulator may result from misuse Only personnel instructed and trained in its use should operate this Continuous Subglottic Suction Regulator INSTALLATION The PM9100 Continuous Subglottic Suction Regulator has a 1 8 NPT female inlet connection on the back of the regulator There are two 2 configurations available for purchase 1 The PM9100 connected directly to the wall suction outlet via a Precision Medical Inc 90 elbow and user specified fitting 2 The PM9100 interfaced with an existing vacuum regulator using a Precision Medical Inc street tee Part 7032 and user specified fitting a Install street tee to back of existing vacuum regulator Ensure the outlet of the tee is pointing in the direction that the regulator is to be mounted b Install Hex connector with regulator attached to street tee c Install suction fitting to street tee d Test connections to ensure they are leak free Leaks may effect the performance accuracy of the PM9100 Continuous Subglottic Suction Regulator SPECIFICATIONS Dimensions 2 19 3 50 88 9mm 58 14 7mm 2 00 50 8mm 3 75 38 ea i 95 3mm 9 6mm y Inlet Connection Tu on Left or Right Side PM9100 Continuous Subglottic Suction Regulator 3 SPECIFICATIONS continued Weight 0 38 Ibs 1 7 kg Shipping Weight 0 53 Ibs 0 24 kg Setting Range for PM9100 20 70 mmHg Vacuum Ports Vacuum Connection 1 8 NPT Patient Conn
11. ust be used with the PM9100 Subglottic Suction Regulator i e Filter Precision Medical Part 1690 Canister equipped with shut off Turn the Vacuum Control Knob to the OFF position Knob must be turned counterclockwise until knob reaches the stop Attach the Suction Regulator to the vacuum source Subglottic suction regulator may be used independently or in combination with a standard suction regulator A REG MODE Regulated Mode 1 Turn the Vacuum Control Knob to the manufacturers recommended suction level for the device being used to accomplish continuous subglottic suction of secretions Typically 15 30 mmHg NOTE Vacuum setting must be increased approximately 20 mmHg for each 12 that the suction Collection Canister is located above patient level 2 Block the bottom port of the PM9100 to verify flow indicator ball disappears from view No Flow Conditon 3 Using the Vacuum Control Knob set the desired vacuum Scale is calibrated for occluded pressures To INCREASE vacuum Turn Knob CLOCKWISE To DECREASE vacuum Turn Knob COUNTERCLOCKWISE 4 Verify vacuum pressure setting with PM760 Digital Vacuum Check Unit B PUSH TO CLEAR MODE Full unregulated vacuum The PM9100 Continuous Subglottic Suction Regulator incorporates a unique flow monitoring mechanism for visual indication to determine the lumen patency of the subglottic suction device AWARNING 1 2 3 The PUSH TO CLEAR but
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