Freedom 60 Instructions for Use
Contents
1. English 8 of 82. Operating pressure 15psi maximum Height sensitivity 3 per 12 30cm Constant force mechanism 3 be ree PPS 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 Pump Weight 140z 0 4kg Length 12 304mm Width 4 5 114mm Height 1 6 41mm Rate Controlled Tubing Length 6 to 72 152mm 1829mm Rate Controlled Tubing Residual Volume cc s Rate Controlled Tubing Residual Volume cc s F0 5 0 012 F30 0 046 F1 0 018 F45 0 056 F2 0 025 F60 0 067 F3 0 030 F120 0 091 F3 8 0 033 F180 0 067 F5 0 039 F275 0 044 F8 0 039 F600 0 020 F10 0 031 F900 0 013 F15 0 066 F1200 0 010 F20 0 028 F2400 0 075 English 7 of 8 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
3. 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 Manufacturers 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 Misuse includes but is not limited to use without compliance with the device operating instructions or use with non approved accessories or disposable items 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 MERCHANTA
4. a local anesthetic directly into the intraoperative site for postoperative pain management Contraindications The Freedom60 is not intended for the delivery of whole blood critical or life sustaining medications or for the infusion of insulin AN Caution Use the Freedom60 Syringe Infusion System only for the patient in which the device is prescribed and only for its intended use Use only Freedom60 tubing sets manufactured by RMS Medical Products Use of any other tubing set will cause the syringe to eject from the pump and eventually cause internal damage to the pump Use of any other tubing set may also cause over delivery of fluids or medication to the patient 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 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 Over use of the slide clamp or storing tubing sets where the slide clamp has been 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 Syr
5. the end of its track wind the large knob clockwise 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 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 clockwise 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 whirling 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 4 Remove the cap from the male end of the tubing and connect the tubing to the patients indwelling catheter 5 __ Turn the pump on to begin the infusion Note Once the black tab finds the syringe plunger and the click sound is heard the pump wil
6. to absorb in the time desired If you believe the rate is too slow you should check the needle sites It is best to avoid areas of scar tissue or on top of muscle It is also possible you may need more sites longer needles or a faster flow rate tubing set Continuous flow even when the pump is turned OFF 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 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 You can also use the slide clamp We recommend only using the slide clamp to immediately stop the flow 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 Subcutaneous swelling pain or redness at the site Try to insert subcutaneous needles dry IgG tends to irritate the skin Assure that the needles are long enough to reach the sub q layers Assure that the needles aren t too long as they may be in muscle Try using a slower flow rated tubing set as the rate may be too fast Think about site location If you have been rotating sites and found locations that do not cause pain it may be preferable to return to the sites that work best Care and Maintenance The Freedom60 does not require any
7. 80ml hr F180 5ml hr F5 275ml hr F275 8ml hr F8 600ml hr F600 10ml hr F10 900ml hr F900 15ml hr F15 1200ml hr F1200 20ml hr F20 2400ml hr F2400 Note Colors have been added to certain flow rates in order to identify those most commonly used for antibiotics They are used only to identify them as most common and can be used to help aid in the selection of rates when there are multiple rates present They do not bear any other meaning or change the performance in any way F15 Orange F20 Purple F30 Red F45 Teal F60 Green F120 Blue Syringes for use with the Freedom60 Becton Dickinson amp Co BD Luer Lok 60ml US Reference 309653 EU Reference 300865 Sherwood Medical Monoject 60ml Reference 8881 560125 SYRINGE SHIELD TRACK END MALE END OF TUBING English 2 of 8 Testing the Freedom60 Syringe Infusion Pump Prior to Use 1 2 3 Examine the inside of the syringe shield and ensure it is free of debris or contamination 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 Turn the pump ON and watch that the tab moves smoothly the full length of its track listen for the following sounds a click as the pump is turned ON a whirling sound as the black tab moves forward a
8. BILITY 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 exceed 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 NY USA Definition of symbols On Z Use by YYYY MM DD or YYYY MM Do not reuse OFF Off LOT Batch code sv Serial number Caution consult accompanying Manufacturer documents STERE Sterilized using irradiation Consult instructions for use TY Quantity 7 a gt Authorized representative in the European Community Catalog number EEN m EC REP RMS UK Ltd wa RMS Medical Products 28 Trinity Rd 24 Carpenter Rd Nailsea Somerset Chester NY 10918 USA BS48 4NU UK Ph 800 624 9600 845 469 2042 www rmsmedicalproducts com WWW FREEDOM60 COM C 0297 o MEDICAL PRODUCTS Patent No 398 053 337125 Rev C
9. FREEDOMGO Syringe Infusion System 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 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 This new Dynamic Equilibrium technology results in a fast and safe infusion with minimal patient complications 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 For SClg the advantage of dynamic equilibrium is the system s ability to decrease the flow for any pressure increases caused by tissue saturation improper needle placement e g over a muscle in scar tissue needle not deep enough needles too close together etc Indications for Use The Freedom60 Syringe Infusion System is indicated for intravenous intra arterial enteral subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates The Freedom60 is also intended to provide continuous infusion of
10. click as the tab reaches the end of its travel 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 Syringe Load and Remove Instructions Step 1 os Load the prefilled syringe After the infusion is complete Make sure that the pump s on off switch is in the OFF tubing attached with turn the pump OFF and wind position and that the black tab gradations facing up plunger the large knob clockwise until within the syringe shield is at first into the syringe shield the black tab is at the end of its the end of its track If the black Make sure the tubing luer disc track Remove the empty tab is not at the end of its track is fully seated in the pump s syringe by gently pushing it wind the large knob clockwise nose back and 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 Administering Intravenous IV Antibiotics Note The chart below is intended for antibiotics and drug with low viscosity DO NOT use this chart for IgG desferal or other viscous fluids Drugs with greater viscosity will flow significantly slower and can be compensated for by using a faster flow rate tubing set To assist you in determining what flow rate tubing set is to be used wit
11. h these drugs we provide special computer calculators that give you the ability to perform these calculations Again the chart below is for antibiotics and drugs with low viscosity only Freedom60 Rate Controlled Tubing Sterile Water for Infusion SWFI Flow Rate Time Chart Synon F1 F2 F30 F45 F60 F120 5 5 hrs 2 hrs 30 min 10 min 6 min 42 sec 5 min 2 min 30 sec 10 10 hrs 5 hrs 20 min 13 min 18 sec 10 min 5 min 15 15 hrs 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 50 min 33 min 18 sec 25 min 12 min 30 sec 30 30 hrs 15 hrs 60 min 40 min 30 min 15 min 35 35 hrs 17 hrs 30 min 70 min 46 min 42 sec 35 min 17 min 30 sec 40 40 hrs 20 hrs 80 min 53 min 18 sec 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 30 min 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 Custom tubing sets available upon request English 3 of 8 Starting the Infusion Before loading the syringe verify the following Make sure that the pump s on off switch is in the OFF position m Make sure that the black tab inside the syringe shield is at the end of its track If the black tab is not at
12. in the OFF position 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 Verify that you are using the correct rate controlled tubing set calculated by the Freedom60 IgG calculator 1 Using sterile technique remove the sterile cap from the luer disc end of the rate controlled tubing set and connect to the pre filled syringe 2 Remove the sterile cap from the end of the sub q needle set and attach it to the male end of the rate controlled tubing set 3 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 clockwise 4 Turn the pump ON to prime the tubing but try not to let the drug drip out of the needles To minimize site pain reactions it is recommended to insert the needles dry To stop flow to the needles turn the pump OFF and wind the large knob clockwise until the black tab is away from the syringe plunger This will release pressure on the plunger 5 Select your sites and cleanse with alcohol Once dry pinch the skin and insert each need
13. inge 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 Discontinue use of a pump that has been damaged exposed to severe impact or which has failed 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 English 1 of 8 Freedom60 Pump Diagram PUMP NOSE WIND UP KNOB LUER DISC END OF TUBING Freedom60 Product Line Each Freedom60 Syringe Infusion System includes a travel pouch and user manual Product Part FREEDOM60 Syringe Infusion Pump F10050 Travel Pouch F10090 Rate Controlled Tubing case of 50 Flow Rate Part Flow Rate Part 0 5ml hr F0 5 30ml hr F30 1ml hr F1 45ml hr F45 2ml hr F2 60ml hr F60 3ml hr F3 120ml hr F120 3 8ml hr F3 8 1
14. l then be totally silent for the entire infusion Checking Infusion Progress Periodically check infusion progress by taking note of the time the infusion started and checking movement of the syringe plunger The approximate rate for antibiotics or other non viscous solutions can be found on the waterproof label attached to the tubing i e F60 will flow at 60ml hr F30 will flow at 30ml hr etc End of Infusion 1 Confirm that the syringe is empty 2 Turn the pump OFF and wind the large knob clockwise until the black tab is at the end of its track 3 Disconnect the tubing from the patients indwelling catheter 4 Gently lift the syringe back and up out of the pump Note If the dose is greater than 60ml and an additional syringe is required load the additional syringe by repeating section titled Starting the Infusion Administering Subcutaneous Immunoglobulin SClg Note You MUST use the Freedom60 IgG Calculator to select the appropriate rate controlled tubing set needed to perform the infusion in the time desired for each IgG patient Failure to use the calculator will result in extremely long infusion times The labeled flow rate on each tubing set is true only for antibiotics and solutions with low viscosity This calculator can be downloaded through our website at www rmsmedicalproducts com or www freedom60 com Before loading the syringe verify the following Make sure that the pump s on off switch is
15. le subcutaneously Secure with adhesive dressing 6 To check for blood backflow remove the syringe by gently lifting it back and up out of the pump English 4 of 8 7 With the syringe out of the pump gently pull back on the plunger Make sure no red or pink exists in the tubing If blood backflow does exist clamp the flow to that site and use the IgG calculator to determine if the dose can be run using the remaining sites If so continue If not remove all needles attach a new needle set and start again from step 2 8 Insert the syringe back into the pump and turn the pump ON to begin the infusion 9 Once the infusion is complete turn the pump OFF and remove all needles 10 Wind the large knob until the black tab is at the end of its track and remove the syringe Troubleshooting If the suggestions in this section do not solve your problem or if problems persist discontinue use and consult our office and or your medical provider Syringe will not load or remove from pump You will never need to use force to load or remove a syringe 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 clockwise and try again Syringe will not stay inside in the pump Make sure you are using the proprietary Freedom60 rate controlled tubing sets with the luer disc Make sure the luer disc end of the tubing has bee
16. n connected to a 60ml syringe and that it is seated properly in the nose of the pump f you are using the pump for a sub q infusion make sure you have not attached the syringe directly to a sub q needle set No flow Assure that the pump is in the ON position Make sure the slide clamp is unclamped or has not been used for an extensive period of time If the slide clamp is overused it can damage the tubing Test the tubing While the pump is in the ON position use sterile procedures to disconnect the rate controlled tubing set from the indwelling catheter IV or needle set sub q 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 catheter or needle set Slow flow intravenous If a 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 10mls in 10 minutes 1ml per minute For 120ml hr tubing the plunger should move 10mls in 5 minutes 2mls per minute Subcutaneous Administration may be slow based on how well the patient s tissue absorbs medication If this is the patient s first time with SClg it may take longer than expected because the body may need to create space in the subcutaneous layers in order
17. 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 English 5 of 8 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 If absolutely necessary you may clean the inside of the syringe shield by using a long swab or bottlebrush and any cleaning agent compatible with ABS and PC plastics Alcohol is not recommended Storage Store the Freedom60 pump in a cool dry place and packaged tubing sets at room temperature approximately 16 30C or 61 86F Testing Flow Accuracy if required by your local protocol Fill a new syringe with 60ml of sterile water Remove all air from the syringe Attach a sterile Freedom60
18. r 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 6 of 8 Freedom60 Flow Profile The Freedom60 flow profile shows that the flow rate is consistent throughout the delivery of medication Freedom60 Flow Rate vs Time Fluid H20 Fluid Volume 60ml Tubing Measured F120 120ml hr 180 160 140 120 100 4 80 Flow Rate ml hr 60 40 4 20 4 OR GN 4 amp 6 6 FF ODL DK OH 0 YD PD P Time Minutes Technical Specifications System Reservoir volume 60ml maximum Residual volume lt 0 4ml Flow rate accuracy 7
19. 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 Compare your test results to the range of test rates listed in the table below NOaAPON gt Labeled Flow Rate Bench Rated Flow Rate 1 Test Range 2 60ml hr 72ml hr 60 84ml hr 120ml hr 132ml hr 115 153ml hr 1 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 72 milliliters per hour A 120ml hr labeled tubing set will generate a nominal bench test rate of 132 milliliters per hour 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 120ml hr Tubing Best Test Rate 72 132 Less Clinical Effects Catheter Gauge 20G PICC 7 8 Fluid Viscosity D5W 2 3 Venous Pressure 3 3 Label Flow Rate 60 120 2 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 numbe
20. under normal use if used in accordance with device operating instructions Warranty is limited to Original Purchaser for one year from date of purchase The Original Purchaser is the person purchasing the infusion pump from the Manufacturer or Manufacturers 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 Manufacturers Representative within the one 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 one year warranty period This warranty does not apply to accessor ies and disposable items 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
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