the User Manual - Clinical Resources, inc
Contents
1. 1992 English 11 of 15 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 Freedom60 Rate Controlled Tubing Sterile Water for Infusion SWFI Flow Rate Time Chart 2 hrs 30 min 10 min 5 hrs 20 min 7 hrs 30 min 30 min 10 hrs 40 min F45 F120 Storage Store the Freedom60 pump in a cool dry place and packaged tubing sets at room temperature approximately 16 30C or 61 86F 6 min 42 sec 5 min 2 min 30 sec 13 min 18 sec 10 min 5 min 20 min 15 min 7 min 30 sec Testing Flow Accuracy if required by your local protocol TRE et jan min Sec min min 1 Fill anew syringe with 60ml of sterile water 2 Remove all air from the syringe 12 hrs 30 min 50 min 33 min 18 sec 25 min 12 min 30 sec oe a ee set to the syringe 15 hrs 60 min 40 min 30 min 15 min Remove all air from the tubing se 5 Load the syringe into the pump and turn the pump ON 17 hrs 30 min 70 min 46 min 42 sec 35 min 17 min 30 sec 6 Monitor the syringe readings and elapsed time to derive an approximate 20 hrs 80 min 53 min 18 sec 40 min 20 min flow rate 45 45 hrs 22 hrs 30 min 90 min 60 min 45 min 22 min 30 sec 7 Compare your test results to the range of test rates listed in the table 66 min 42 sec 50 min 25 min2. below 25 hrs 100 min 27 hrs 30 min 110 min 73 min 18 sec 55 min 27 min 30 sec Labeled Flow Rate Bench Rated Flow Rate 1 Test Range 2 60 60hrs 30 hrs 120 min 80 min 60 min 30 min 61 83ml hr 113 154ml hr 60ml hr 72ml hr Starting the Infusion Before loading the syringe verify the following Make sure that the pump s on off switch is in the OFF position Make sure that the black tab inside the syringe shield is at the end of its 120ml hr 134ml 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 134 milliliters per hour The Freedom60 generates nominal bench test rates higher than the labeled rate accounting for track If the black tab is not at the end of its track wind the large knob clockwise Verify that you have the correct rate controlled tubing set the following standardized application criteria that affects actual delivery rates under normal Clinical circumstances 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 syring
3. 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 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
4. warranty does not apply to accessories and disposable items 3 8ml hr 180mI hr F180 7 a 5ml hr 275mV hr_ F275 The following conditions procedures and limitations apply to the Manufacturer s 8ml hr 600mi hr F600 obligations under this warranty 10ml hr F10 900ml hr F900 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 20ml hr 2400ml hr English 4 of 15 English 13 of 15 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 e Fluid Volume 60ml Tubing Measured F120 120ml hr 180 160 140 N O oO oO Flow Rate ml hr CO O O O 40 SN SF amp 6 FF DYN De O GO BD IONADAN PW P SH Time Minutes Technical Specifications System Reservoir volume 60ml maximum Residual volume lt 0 4ml Flow rate accuracy 8 Operating pressure 15psi maximum 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 8 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 temperatur
5. FREEDOMGO i Syringe Infusion System INSTRUCTIONS FOR USE M OdUCUON serririssreisnrinoadsnet anra Nadan 2 indications Tor WS Cx atecccnciacdusveaitinnesivandeanbareaddienucieant 2 ContraindicatonS siccesaresaericestdtere sonatas 2 SAO e A AOI 3 Freedom60 Pump Diagram cccccccseeceeeeeeeeeeeees 4 Freedom60 Product Line ccccceseeccseeeeeeeeeseeeees 4 syringes for Use with Freedom60 cc00eceeee 5 Testing Freedom60 Prior to US ccccceeeeee eee 5 syringe Load Remove Instructions ccceeeeeee 6 Administering Antibiotics cccccccceceseeeeeeeeeeeeeees 6 TVOUDICS HOO TING iecere 8 Care and Maintenance ccccccecceeeceeeeeeeeeeeeeeeeees 9 Freedom60 Flow Profile 12 Technical Specifications cccccecccceeeeeeeeeeeeaeeesees 12 Warranty Information ccccccceccsecceeeseeeeeeeeeeseeeaees 13 Definition Of SYMDOIS roaring 15 English 1 of 15 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 resistanc
6. NOSE Length 6 to 72 152mm 1829mm TRACK END Rate Controlled Tubing Residual Volume cc s WIND UP KNOB LUER DISC END OF TUBING MALE END OF TUBING Warranty Information Limited Warranty RMS Medical Products Repro Med Systems Inc Freedom60 Product Line Manufacturer warrants the infusion pump to be free from defects in materials Each Freedom60 Syringe Infusion System includes a travel pouch and user and workmanship under normal use if used in accordance with device operating manual instructions Warranty is limited to Original Purchaser for one year from date of purchase The Original Purchaser is the person purchasing the infusion pump Product Part from the Manufacturer or Manufacturers Representative Warranty does not FREEDOM60 Syringe Infusion Pump F10050 extend to subsequent purchasers Subject to the conditions of and upon Travel Pouch F10090 compliance with the procedures set forth in this limited warranty the Manufacturer will repair or replace at its option any infusion pump or part Rate Controlled Tubing case of 50 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
7. e 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 whole blood critical or life sustaining medications or for the infusion of insulin English 2 of 15 Definition of symbols Manufacturer On cs documents B Use by YYYY MM DD or YYYY MM STERILE R Sterilized using irradiation RMS UK Ltd RMS Medical Products FRM 24 Carpenter Rd o nicat 1S 28 Trinity Rd Nailsea Somerset Chester NY 10918 USA BS48 4NU UK Ph 800 624 9600 845 469 2042 www rmsmedicalproducts com C 0297 Patent No 398 053 337125 Rev C WWW FREEDOM60 COM English 15 of 15 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 Manufactur
8. e 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 15 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 TOStNg t ne Freedom60 Syringe Infusion Pump 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 the full length of its track listen for the following sounds a click as the pum
9. e 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 English 10 of 15 English 7 of 15 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 patient s indwelling needle or 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 will 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 lab
10. el attached to the tubing i e F60 will flow at 6Oml hr F30 will flow at 30ml hr etc End of Infusion 1 Confirm that the syringe is empty 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 patient 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 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 been connected to a 60ml syringe and that it is seated properly in the nose of the pump 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
11. ers 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 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 exceed to special indirect
12. he 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 15
13. 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 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 This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of NY USA English 14 0f 15 English 3 of 15 Freedom60 Pump Diagram Pump ae Weight 140z 0 4kg iti Length 12 304mm x Pa SYRINGE SHIELD Width 4 5 114mm ae IP Height 1 6 41mm ha Rate Controlled Tubing PUMP
14. ow rate tubing set To assist you in determining what flow rate tubing set is to be used with these drugs please contact us at 1 800 624 9600 Again the chart below is for drugs with low viscosity only English 6 of 15 Pm Tubing 120mI hr Tubing Best Test Rate 72 Less Clinical Effects 7 2 3 60 T20 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 number of pumps tested within 8 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 lf 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 II 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
15. p is turned ON a whirling sound as the black tab moves forward 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 15 Syringe Load and Remove Instructions SL Step 3 Step x After the infusion is complete turn the pump OFF and wind the large Make sure that the pump s on off switch is in the OFF position and that the black tab within the syringe shield plunger first into the syringe knob clockwise until the Load the prefilled syringe tubing attached with gradations facing up is at the end of its track If the black tab is not at the end of its track wind the large knob clockwise shield Make sure the tubing black tab is at the end of its luer disc is fully seated in track Remove the empty the pump s nose syringe by gently pushing it 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 Antibiotics Note The chart below is intended for drugs 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 fl
16. tubing English 8 of 15 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 or catheter Slow flow 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 10mls in 10 minutes 1ml per minute For 120ml hr tubing the plunger should move 10mls in 5 minutes 2mls per minute 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 Care and Maintenance T
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