English EN - Repro-Med Systems, Inc.
Contents
1. 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 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 subcutaneous 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 Pe ee ee Ch edie Se ee i sts i lt is SS OY s a s s a gme T 0 6 6 66 gut _ _ _ _ __ _ _ oi SES PPP Pe Enung TT gg SSE a em A ce er ols Son pee a a NM a a O o a ET ee a o a a A E mm n SOE E e E E Enun ee a peeeeee English EN 4of8 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 pres2. Flow Profile The FREEDOM60 flow profile shows that the flow rate is consistent throughout the delivery of medication FREEDOM60 Flow Rate vs Time Fluid H O Fluid Volume 60ml Tubing Measured F120 120ml hr Flow Rate ml hr SN S amp GF FD GD VW DB nw GO GH HB B DP ad qd qk Gf qo ap xe vO Time Minutes Technical Specifications System Reservoir volume 60ml maximum Residual volume lt 0 4ml Flow rate accuracy Se Operating pressure 13 5psi 93079 125 Pa Nominal 15psi 103421 25 Pa Peak 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 Pump Rate Controlled Tubing Weight 140z 0 4kg Length 6 to 72 152mm 1829mm Length 12 304mm Width 4 5 114mm Height 1 6 41mm Rate Controlled Tubing Residual Volume ml FREEDOM
3. 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 a local anesthetic directly into the intraoperative site for postoperative pain management 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 In the UK and certain other countries these may be limited by local regulations CONSULT LOCAL REGULATORY AUTHORITIES J Caution e Use the FREEDOM60 Syringe Infusion System only for the patient for whom the device is prescribed and only for its intended use e Use only FREEDOM60 Precision Flow Rate Tubing Sets manufactured by RMS Medical Products Use of any other tubing set may 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 e Use only recommended 60ml syringes with the FREEDOM60 Do not use Terumo syringes e Do not use syringes smaller than 60ml The use of a smaller syringe may cause high pressures unsafe for the patient e Before use carefully inspect the tubing set package Do not use the tubing set if the pa
4. 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 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 Definition of symbols Caution consult accompanying STERILE R T et Authorized representative in the RMS Medical P
5. redness at the site Try to insert subcutaneous needles dry IgG tends to irritate the skin e Assure that the needles are long enough to reach the subcutaneous layers e Assure that the needles aren t too long as they may be in muscle e Try using a slower flow rated tubing set as the rate may be too fast e 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 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
6. 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 The FREEDOM60 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 Filla new syringe with 60ml of sterile water Remove all air from the syringe Attach a sterile FREEDOM60 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 Labeled Flow Rate Bench Rated Flow Rate 60ml hr 72ml hr 60 84ml hr 120ml hr 134ml 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 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 circumstance
7. 6O E pfecision LOW RATE TUBING F900 Fo omo F200 F2400 CESES eee Cilia Se Ue ss i i sl NS Eee C i lle s a s a a s Ce T 0 6 6 nuuetIttij _ _ ____ _ __ cr sESEEEEERN anya o E ag SE ime SS i E T O Ne a a a So oe gg ELC a E amelie o ee a a Me a a a A EE Mp C ee a ee ee a peoempeee English EN 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 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 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 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
8. ckage is opened or damaged e Do not re sterilize tubing sets e 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 e 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 e 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 e 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 e 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 e Discontinue use of a pump that has been damaged exposed to severe impact or which has failed to test properly e Discontinue use of a pump that has been submerged i
9. e examples on page 6 3 SWEI flow rates will be reduced from stated values Typically used for viscous drugs LOW RATE TUBING 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 5601 25 ee wee OU Ey oo E eC cc s lle s a va s a s dc a uuuullll a peseununnanes i eguilllllMMREEEEESS a a a ll i n a a a p meo a NM o aE eg SSM le ee te eee iw gg BE hMh lc sh E CE a Ce E a seen e nee eeeee English EN 2of8 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 the full length of its track listen for the following sounds e a click as the pump is turned ON e 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 Syringe Loading and Removal Instruction
10. ent 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 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 e This is anormal 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 e Verify that you are using the proper BD or Monoject brand 60ml syringe Do not use Terumo syringes see ee eee 6 a ee a ie O eee ls ti sstsi i isl Enc cc C nelle s a s s a s Cd c T neat _ _ _ _ __ _ se BBB UP Peewee tt a a im SL ei eee Ne E a a a a ope a gg NLC S O S ll acme tI o ee a a a o a a A E me Punnett a ee ee a ee nE English EN 5 of 8 Subcutaneous swelling pain or
11. gin the infusion Note Once the black tab finds the syringe plunger and the click sound is heard the pump will be 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 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 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 Immunoglobulin 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 freedom60calculator com
12. he 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 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 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 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 be
13. ill not stay inside in the pump e Make sure you are using the proprietary FREEDOM60 Precision Flow Rate Tubing sets with the luer disc e 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 If you are using the pump for a subcutaneous infusion make sure you have not attached the syringe directly to a subcutaneous needle set No flow e Assure that the pump is in the ON position e 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 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 catheter IV or needle set subcutaneous 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 e 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 10ml in 10 minutes Iml min For 120ml hr tubing the plunger should move 10ml in 5 minutes 2ml min e Subcutaneous Administration may be slow based on how well the pati
14. n fluid If any fluid is allowed to enter the pump it should be replaced immediately e Do not autoclave the FREEDOM60 It will melt the ABS plastic and damage the pump e In the USA federal law restricts this device to sale by or on order of a physician e 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 suse PPP eee eee ses Ty s eed Cc cc C png e s ma s s a s dc T nega _ _ _ _ _ _ _ sEB BBP Be eee ass Tlt i i is s SOC UOOO a ag SE i mm o i eel Ne tsti i C CS Sone ge a a nt a O O G S ll o a a a a a E Mg a A a E CE E a C E a a eee ee peoempeee English EN 1 of 8 FREEDOM60 Pump Diagram TREEDUMOU Een Seehte2 Syringe Infusion System SYRINGE SHIELD END OF TRACK PUMP NOSE TRACK END LARGE KNOB WIND UP KNOB LUER DISC END OF TUBING MALE END OF 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 Pediatric Travel Pouch F10100 Rate Controlled Tubing case of 50 Part FlowRate Part FlowRate FREEDOM6O m Fogg 00 F Sterile water for injection SWFI direct flow rates Adjusted for antibiotic use for actual flow rates se
15. not apply to accessories and disposable items The following conditions procedures and limitations apply to the Manufacturer s obligations under this warranty e 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 e 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 Misuse includes but is not limited to use without compliance with the device operating instructions or use with
16. roducts UK Ltd RMS Medical Products EC REP 146 Allerton Rd 24 Carpenter Rd C mM S amp S Mossley Hill Liverpool T a De USA C MEDICAL PRODUCTS L18 2DH UK 845 469 204 www rmsmedicalproducts com C 0297 F10050_English_EN_ Rev F FREEDOM60 is compliant with Medical Device Directive 93 42 EEC RMS Medical Products is ISO 13485 certified Pe ee ee ee seaeeeeee T wwe Se Ue ss i i sl NS eee M lle s a s s a gme a nuuutItt _ _ _ __ rR a a a O Sini anann a a a a p pee gg NM a a eg SEE a mle ll ltl lc a Me a a a A EE CE E ia SO E R E E Enan ee a CO English EN 8of8
17. s oom Taing 120mirhe Tubing 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 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 NAM BWN 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 ee ee ee eeu eeeeee ee enna mee T Se eee ti ststs lt isSOsSsS NS Dc S inl s a s a a s s a s sePP PCB S cg T mm ee el NS a a nme NEE O mt ll ng hUll hhc rr re gE Rees 8 CE E a ial CE a E a ee ee English EN 6 of 8 FREEDOM60
18. s To load a syringe To remove a syringe Make sure that the pump s With the tubing attached and After the infusion is complete turn on off switch is in the OFF gradations facing up load the the pump OFF and wind the large position and that the black tab pre filled syringe plunger first knob clockwise until the black tab is within the syringe shield isat into the syringe shield Make at the end of its track Remove the the end of its track If the black sure the tubing luer disc is fully empty syringe by gently pushing tab is not at the end of its track seated in the pump s nose it back to disengage the nose wind the large knob clockwise 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 Drug viscosity will greatly affect delivery times For assistance in determining which flow rate tubing set to use please contact your local representative or RMS Medical Products at 1 845 469 2042 or via email at info rmsmedicalproducts com Flow Rate vs Time Chart ate 120th English EN 3 of 8 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 t
19. sues eneeeg annans O Tue s a o a i _ s qj qalddd lt lt iactse Gi a a 8 _ SSH nn i ae a ee a ae SNERERE r Siig 3 ee a A g ee C ee aa wie Gs eo Sere ee Introduction The FREEDOM60 Syringe Infusion System is portable and easy to use requiring Syringe Infusion System 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 93079 125 Pa 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 or improper needle placement e g over a muscle in scar tissue needle not deep enough needles too close together Indications for Use The FREEDOM60 Syringe Infusion System is
20. sure on the plunger 5 Select your sites and cleanse with alcohol Once dry pinch the skin and insert each needle 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 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 End of Infusion 1 Once the infusion is complete turn the pump OFF and remove all needles 2 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 RMS Medical Products and or your medical provider Syringe will not load or remove from pump e You will never need to use force to load or remove a syringe e 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 e Verify that you are using the proper BD or Monoject brand 60ml syringe Syringe w
Download Pdf Manuals
Related Search