FREEDOM60® Instructions For Use - Repro
Contents
1. Authorized representative in the European Community 2e REE Serial number wo fg H Use by YYYY MM DD or YYYY MM Sere fR Sterilized using irradiation LOT Batch code English 15 of 16 OS EC REP RMS Medical Products UK Ltd 146 Allerton Road Mossley Hill Liverpool L18 2DH UK MADE IN RMS MEDICAL PRODUCTS RMS Medical Products 24 Carpenter Road Chester NY 10918 USA g Ph 800 624 9600 845 469 2042 www rmsmedicalproducts com C 02 97 The FREEDOM60 Syringe Infusion System and RMS Precision Flow Rate Tubing are compliant with Medical Device Directive 93 42 EEC RMS Medical Products is ISO 13485 certified 337125 Rev K2. FREEDOM60 Syringe Infusion System Instructions For Use Introduction gocroaiecuncvoroumwws cen cleuesmwadactecwa 2 Indications for Use nunnan neasa cece eee ees 2 COMEAMGICANONS ccscsccasausunoudasteniaeiandacse 2 COMblONicntatasatcctecteursassateataatasaasaaesasaess 3 FREEDOM60 Pump Diagram 4 FREEDOM60 Product Line 0005 4 Syringes for Use with FREEDOM60 5 Testing FREEDOM60 Syringe Infusion Pump 5 Syringe Loading and Removal Instructions 6 Selected Flow Rates vs Time 000eee eee 6 Starting the Infusion cece eee eee eee 7 Checking Infusion Progress 0 0e000 8 End of Infusion c gsreditietent beasties beae detcn nace srecn sonra Snare dusts 8 Troubleshooting 6 cece cence cece eee ee 8 Care and Maintenance e cece cena 9 FREEDOM60 Flow Profile 00 eee 12 Technical Specifications 0 0 02 e cece 12 Warranty Information 220 208 13 Definition of Symbols ususse 15 English 1 of 16 Introduction The FREEDOM60 Syringe Infusion System is portable and easy to use requiring no batteries or electric There are only two operating knobs and special precision tubing sets are used to control the flow rate The FREEDOM60 operates at a constant safe pressure of 13 5psi The constant pressure developed in the
3. FREEDOMG60 Flow Rate vs Time Fluid H20 Fluid Volume 60ml Tubing Measured F120 120ml hr 180 7 160 140 N Oo Q ee Flow Rate ml hr fo oO D oO Peace ee E GN amp GF FD ND ke O OG GB LP E PO H 20 Time minutes Technical Specifications System Reservoir volume 60ml maximum Residual volume lt 0 4ml Flow rate accuracy 7 Operating pressure 15psi peak 13 5psi nominal Height sensitivity 3 per 12 30cm Constant force mechanism 3 Flow rate data recorded at 22 C using 60ml of 0 9 NS An overall accuracy of 7 is expected at these values At higher temperatures which results in a decrease in viscosity a higher flow rate is anticipated to occur The flow rate variation due to changes in temperature is approximately linear and would vary from 20 at 14 C to 20 at 30 C Fluids considerably more viscous than 0 9 NS are expected to slow the flow rate and consequently may result in longer infusion times More viscous fluids may be tested before patient use by following the bench test procedures described in this manual English 12 of 16 Pump Weight 140z 0 4kg Length 12 304mm Width 4 5 114mm Height 1 6 41mm RMS Precision Flow Rate Tubing Length 6 to 72 152mm 1829mm RMS Precision Flow Rate Tubing Residual Volume ml precision LOW RATE TU
4. Limitations and Exclusions Repair or replacement of an infusion pump or component part is the EXCLUSIVE remedy offered by the Manufacturer The following exclusions and limitations shall apply o No agent representative or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty expressed or implied or to change this limited warranty in any way o THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE THERE ARE NO WARRANTIES THAT EXTEND BEYOND THE DESCRIPTION ON THE FACE HEREOF o Manufacturer s liability under this Limited Warranty Agreement shall not extend to special indirect or consequential damages o The infusion pump can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the infusion pump for a particular medical treatment o All recommendations information and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reliable but do not constitute warranties This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of New York USA English 14 of 16 Definition of symbols On Manufacturer OFF Off T Quantity Caution Catalog number Consult instructions for use Do not reuse
5. Make sure that the pump s With the tubing attached After the infusion is on off switch isin the OFF and gradations facing up complete turn the pump position and that the black load the pre filled syringe OFF and wind the large knob tab within the syringe shield plunger first into the syringe clockwise until the black tab is at the end of its track If shield Make sure the tubing is at the end of its track the black tab is not at the luer disc is fully seated inthe Remove the empty syringe end of its track wind the pump s nose by gently pushing it back to large knob clockwise disengage the nose then lifting it up out of the pump Note You will never need to use force to load or remove a syringe If you re having trouble loading or removing stop and make sure the black tab is at the end of its track Selected Flow Rates vs Time Note For assistance in determining which flow rate tubing set to use please contact RMS Medical Products at 800 624 9600 English 6 of 16 Flow Rate vs Time Chart eying ami he 2mi hr 30ml hr 45mi hr 60ml hr 120ml hr 5 5 hrs 2 hrs 30 min 10 min 6 min 42 sec 5 min 2 min 30sec 10 10 hrs 5 hrs 20 min 13 min 18 sec 10 min 5 min 15 15hrs 7 hrs 30 min 30 min 20 min 15 min 7 min 30 sec 20 20 hrs 10 hrs 40 min 26 min 42 sec 20 min 10 min 25 25 hrs 12 hrs 30 min 50min 33 min 18 sec 25 min
6. 12 min 30 sec 30 30 hrs 15 hrs 60 min 40 min 30 min 15 min 35 35 hrs 17 hrs 30 min 70min 46 min 42 sec 35 min 17 min 30 sec 40 40 hrs 20 hrs 80min 53min 18sec 40 min 20 min 45 45 hrs 22 hrs 30 min 90 min 60 min 45 min 22 min 30 sec 50 50 hrs 25 hrs 100 min 66 min 42 sec 50 min 25 min 55 55 hrs 27 hrs 30min 110 min 73 min 18 sec 55 min 27 min 30 sec 60 60 hrs 30 hrs 120 min 80 min 60 min 30 min Starting the Infusion Before loading the syringe verify the following e Make sure that the pump s on off switch is in the OFF position e Make sure that the black tab inside the syringe shield is at the end of its track If the black tab is not at the end of its track wind the large knob clockwise e Verify that you have the correct rate controlled tubing set 1 Using sterile technique remove the sterile cap from the luer disc end of the rate controlled tubing set and connect the tubing to the pre filled syringe 2 With syringe gradations facing up insert the syringe plunger first into the syringe shield Make sure the luer disc is fully seated in the pump s nose Note You will never need to use force to load or remove a syringe If you are having trouble loading removing make sure the pump is in the OFF position and that the black tab is at the end of its track If the black tab is not at the end of its track fully wind the large knob clockwis
7. Before use carefully inspect the tubing set package Do not use the tubing set if the package is opened or damaged Do not re sterilize tubing sets Overuse of the slide clamp or storing tubing sets with the slide clamp engaged for long periods of time may damage the tubing and affect the infusion rate The black tab that pushes on the syringe plunger operates under high force Do not place fingers on the black tab or inside the syringe shield at any time Do not attempt to interfere with the movement of the black tab at any time Carefully inspect the FREEDOM60 Syringe Infusion Pump before use Verify its condition and test If repeated testing indicates the pump is not operating properly or at the appropriate rate of flow immediately discontinue use Do not attempt to open the pump housing or remove the syringe shield Do not operate if the syringe shield has been removed Do not attempt to remove the syringe or disconnect the tubing set without first turning the pump OFF and fully winding the large knob clockwise until the black tab has reached the end of its track The FREEDOM60 Syringe Infusion System does not have an alarm therefore no alarm will sound if an interruption to flow occurs There is no display of infusion status The pump is not suitable for use with medication where delay or under infusion could result in serious injury Discontinue use of a pump that has been damaged exposed to severe impact or which has fai
8. FREEDOM60 automatically decreases the flow rate if there is an increase in resistance during the delivery The system will find equilibrium between the increasing resistance and flow rate It provides constant flow which tends to inhibit clots and holds full pressure after an infusion is complete to prevent blood or drug backflow The FREEDOM60 also eliminates concerns of a bolus overflow overdose or runaway infusion Indications for Use The FREEDOM60 Syringe Infusion System is indicated for the infusion of prescribed liquid medicines Contraindications The FREEDOM60 is not intended for the delivery of blood critical or life sustaining medications or for the infusion of insulin Critical may be defined as medication requiring greater accuracy of delivery such as CNS opiate depressants which in certain countries e g UK may be limited by local regulations CONSULT LOCAL REGULATORY AUTHORITIES English 2 of 16 A Caution Use the FREEDOM60 Syringe Infusion System only for the patient for whom the device is prescribed and only for its intended use Do not connect an extension tubing or needle set directly to the syringe An appropriate flow restrictive tubing with a disc luer is required for use with FREEDOM60 Use only recommended 60ml syringes with the FREEDOM60 Do not use Terumo syringes Do not use syringes smaller than 60ml The use of a smaller syringe may cause high pressures unsafe for the patient
9. such as household bleach or hydrogen peroxide Avoid the use of alcohol or alcohol containing compounds as these tend to make ABS plastic brittle Wipe again with clean water to rinse English 8 of 16 e Test the tubing While the pump is in the ON position use sterile procedures to disconnect the rate controlled tubing set from the indwelling needle or catheter check for medication drip If medication does not drip replace the tubing as it may be blocked or damaged If medication does drip from the rate controlled tubing then it s most likely a problem with the indwelling needle catheter or any fluid path accessories such as a clave connector or needle free adapter Slow flow e Ifa slide clamp is used for an extensive period of time it can damage the tubing and affect the flow rate Try using another tubing set and measure the flow For 60ml hr tubing the syringe plunger should move 10ml in 10 minutes 1ml min For 120ml hr tubing the plunger should move 10ml in 5 minutes 2ml min Continuous flow even when the pump is turned OFF e This is a normal function of the pump The pump is designed to maintain pressure during and after the infusion to prevent blood drug backflow e To stop the flow turn the pump OFF and wind the large knob clockwise so the black tab moves away from the syringe This will release pressure on the plunger e You can also use the slide clamp We recommend using the slide clamp to immediately stop the
10. BING F45 0 11 Warranty Information Limited Warranty RMS Medical Products Repro Med Systems Inc Manufacturer warrants the infusion pump to be free from defects in materials and workmanship under normal use Warranty is limited to Original Purchaser and covers the FREEDOM60 for a period of two years from the purchase date This warranty is not valid for any damage caused by the use of non RMS products The Original Purchaser is the person purchasing the infusion pump from the Manufacturer or Manufacturer s Representative Warranty does not extend to subsequent purchasers Subject to the conditions of and upon compliance with the procedures set forth in this limited warranty the Manufacturer will repair or replace at its option any infusion pump or part thereof which has been actually received by the Manufacturer or Manufacturer s Representative within the two year warranty period and which examination discloses to the Manufacturer s satisfaction that the product is defective Replacement product and parts are warranted only for the remaining portion of the original two year warranty period RMS rigorously tests the FREEDOM60 using RMS accessories to ensure that the FREEDOM60 operates in accordance with published specification standards If non RMS accessories are used in conjunction with the FREEDOM60 RMS does not represent that the FREEDOM60 will operate in a
11. OM60 pump is recommended to be stored in a cool dry place and packaged tubing sets at room temperature approximately 16 30 C or 61 86 F Testing Flow Accuracy if required by your local protocol 1 Filla new syringe with 60ml of sterile water Remove all air from the syringe Attach a sterile RMS Precision Flow Rate Tubing set to the syringe Remove all air from the tubing set Load the syringe into the pump and turn the pump ON Monitor the syringe readings and elapsed time to derive an approximate flow rate 7 Compare your test results to the range of test rates listed in the table below An BWN Labeled Flow Rate Bench Rated Flow Rate Test Range 60ml hr 72ml hr 60 84ml hr 120ml hr 134ml hr 115 153ml hr 7a Bench Rated Flow Rate The FREEDOM60 infusion pump design accounts for the effects of standard clinical conditions on flow rate performance Under bench test conditions a 60ml hr labeled tubing set is designed to generate a nominal infusion rate of 72ml hr A 120ml hr labeled tubing set will generate a nominal bench test rate of 134ml hr The FREEDOM60 generates nominal bench test rates higher than the labeled rate accounting for the following standardized application criteria that affects actual delivery rates under normal clinical circumstances 60ml hr Tubing 120 ml hr Tubing Bench Test Rate 72ml hr 134ml hr Less Clinical Effects Catheter Gauge 20G PICC 7
12. ccordance with published specification standards The FREEDOM60 warranty does not cover third party products or accessories English 13 of 16 The following conditions procedures and limitations apply to the Manufacturer s obligations under this warranty Parties Covered by this Warranty This warranty extends only to the Original Purchaser of the infusion pump This warranty does not extend to subsequent purchasers Warranty Performance Procedure Notice of the defect must be made in writing to Customer Support Department RMS Medical Products Repro Med Systems Inc 24 Carpenter Road Chester NY 10918 USA Notice to RMS Medical Products Repro Med Systems Inc must include the model and serial number date of purchase and description of the defect in sufficient detail to facilitate repairs Authorization must be obtained by the Original Purchaser from the Manufacturer or Manufacturer s Representative prior to returning the product to the Manufacturer The defective pump must be properly packaged and returned to the Manufacturer postage prepaid Any loss or damage during shipment is at the risk of the Original Purchaser Conditions of Warranty This warranty does not apply to any product or part thereof which has been repaired or altered outside of the Manufacturer s facility in a way so as in Manufacturer s judgment to affect its stability or reliability or which has been subjected to misuse negligence or accident
13. e 3 Using sterile technique prime the tubing with the pump by loosening the cap on the male end and turning the pump ON You will immediately hear a whirring sound as the black tab searches for the syringe plunger When the tab finds the plunger it will click indicating that that the tab is now applying pressure onto the plunger Medication is now being pumped through the tubing set When all air and air bubbles are gone and medication starts to drip tighten the cap NOTE Tubing that is pre primed for antibiotic use and shipped at temperatures below freezing could be damaged English 7 of 16 e Test the tubing While the pump is in the ON position use sterile procedures to disconnect the rate controlled tubing set from the indwelling needle or catheter check for medication drip If medication does not drip replace the tubing as it may be blocked or damaged If medication does drip from the rate controlled tubing then it s most likely a problem with the indwelling needle catheter or any fluid path accessories such as a clave connector or needle free adapter Slow flow e Ifa slide clamp is used for an extensive period of time it can damage the tubing and affect the flow rate Try using another tubing set and measure the flow For 60ml hr tubing the syringe plunger should move 10ml in 10 minutes 1ml min For 120ml hr tubing the plunger should move 10ml in 5 minutes 2ml min Continuous flow even when th
14. e pump is turned OFF e This is a normal function of the pump The pump is designed to maintain pressure during and after the infusion to prevent blood drug backflow e To stop the flow turn the pump OFF and wind the large knob clockwise so the black tab moves away from the syringe This will release pressure on the plunger e You can also use the slide clamp We recommend using the slide clamp to immediately stop the flow only in the case of an emergency Overuse can damage the tubing Medication 5ml or less left in the syringe Verify that you are using the proper BD or Monoject brand 60ml syringe Do not use Terumo syringes Care and Maintenance The FREEDOM60 does not require any preventative maintenance The FREEDOM60 works as a system which means the tubing determines the flow rate not the pump therefore our pump needs no calibration If you choose the correct tubing set the proper flow rate will be achieved Our tubing sets are statistically verified during manufacture and will deliver the appropriate flow rate under controlled conditions Cleaning Clean only those areas that are exposed and external No attempt should be made to clean any part of the pump that is not easily accessible Discontinue use of a pump that has been internally exposed to or immersed in fluid Wipe the surface with warm water and detergent or use any surface disinfectant compatible with acetyl butyl styrene ABS and polycarbonate PC plastics
15. es 10 11 3 SWFI flow rates will be reduced from stated values Typically used for viscous drugs English 4 of 16 For Smaller Volume Infusions The FREEDOM60 is designed to accommodate 60ml syringes For smaller volumes the FreedomEdge accommodates both 20ml and 30ml syringes SJ eedomedge f Part F10020 Syringes for use with the FREEDOM60 e Becton Dickinson amp Co BD Luer Lok 60ml US Reference 309653 EU Reference 300865 e Sherwood Medical Monoject 60ml Reference 8881 560125 Testing the FREEDOM60 Syringe Infusion Pump 1 Examine the inside of the syringe shield and ensure it is free of debris or contamination 2 Make sure that the pump s on off switch is in the OFF position and that the black tab within the syringe shield is at the end of its track If the black tab is not at the end of its track fully wind the large knob clockwise 3 Turn the pump ON and watch that the tab moves smoothly along the full length of its track listen for the following sounds e a click as the pump is turned ON a whirring sound as the black tab moves forward e a click as the tab reaches the end of its travel 4 Test to make sure the syringe tension tab the one inch long tab located at the entry of the syringe shield operates freely by adjusting it up and down with your finger English 5 of 16 Syringe Loading and Removal Instructions To load a syringe To remove a syringe
16. flow only in the case of an emergency Overuse can damage the tubing Medication 5ml or less left in the syringe Verify that you are using the proper BD or Monoject brand 60ml syringe Do not use Terumo syringes Care and Maintenance The FREEDOM60 does not require any preventative maintenance The FREEDOM60 works as a system which means the tubing determines the flow rate not the pump therefore our pump needs no calibration If you choose the correct tubing set the proper flow rate will be achieved Our tubing sets are statistically verified during manufacture and will deliver the appropriate flow rate under controlled conditions Cleaning Clean only those areas that are exposed and external No attempt should be made to clean any part of the pump that is not easily accessible Discontinue use of a pump that has been internally exposed to or immersed in fluid Wipe the surface with warm water and detergent or use any surface disinfectant compatible with acetyl butyl styrene ABS and polycarbonate PC plastics such as household bleach or hydrogen peroxide Avoid the use of alcohol or alcohol containing compounds as these tend to make ABS plastic brittle Wipe again with clean water to rinse English 9 of 16 If absolutely necessary you may clean the inside of the syringe shield by using along swab or bottlebrush and any cleaning agent compatible with ABS and PC plastics Alcohol is not recommended Storage The FREED
17. led to test properly Discontinue use of a pump that has been submerged in fluid If any fluid is allowed to enter the pump it should be replaced immediately Do not autoclave the FREEDOM60 It will melt the ABS plastic and damage the pump Federal law USA restricts this device to sale by or on order of a physician Priming and shipping of tubing sets packaged at temperatures below freezing is not recommended This may damage the tubing For example generally greater than about 2 hours English 3 of 16 FREEDOMG60 Pump Diagram FREEDOM60 Syringe Infusion System Patent No 398 053 SYRINGE SHIELD END OF TRACK TRACK END PUMP NOSE LARGE KNOB WIND UP KNOB LUER DISC END OF FLOW RATE TUBING SLIDE CLAMP MALE END OF FLOW RATE TUBING SYRINGE PLUNGER FREEDOM60 Product Line Each FREEDOM60 Syringe Infusion System includes a travel pouch and user manual FREEDOM60 Syringe Infusion Pump F10050 Travel Pouch F10090 RMS Precision Flow Rate Tubing case of 50 ie 0 5ml hr 60ml hr precision 1ml hr 120ml hr 2ml hr 180ml hr 3ml hr 275ml h 3 8ml hr 420ml h 5ml hr 500ml h 8ml hr 600ml hr 10ml hr 900ml hr 15ml hr 1200ml hr 30ml hr 2400mI hr 45ml hr LOW RATE TUBING 1 Sterile water for injection SWFI direct flow rates Adjusted for antibiotic use for actual flow rates see examples on pag
18. ml hr 8ml hr Fluid Viscosity 2ml hr 3ml hr Venous Pressure 3ml hr 3ml hr Label Flow Rate 60ml hr 120ml hr English 10 of 16 7b Test Range To assure consistent test results keep pump and tubing at the same approximate horizontal plane and monitor flow for a minimum of 20 minutes The FREEDOM60 system is factory rated to deliver infusions under strict test conditions over a large number of pumps tested within 7 of nominal with a 95 statistical confidence interval Under varying bench test and fluid conditions this range can be expected to vary approximately 15 of nominal For more accurate monitoring use a stopwatch and finely graduated burette FREEDOM60 pump testing is based on ANSI AAMI National Standard ID 26 1992 Infusion Devices August 24 1992 If test results in the range indicated cannot be approximated under bench testing conditions factory refurbishment and full certification testing is available from the manufacturer References 1 Stuhmeier Mainzer B MD Aspects of pressure build up in the use of electronic infusion devices Il Need for a pressure limit Anasth Intensivther Notfallmed 1987 Aug 22 4 185 190 2 Anasth Intensivther Notfallmed 1987 Aug 22 4 181 184 ANSI AAMI National Standard ID 26 1992 Infusion Devices August 24 1992 English 11 of 16 FREEDOM60 Flow Profile The FREEDOM60 flow profile shows that the flow rate is consistent throughout the delivery of medication
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