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Warranty Information:

Limited Warranty:

RMS Medical Products/Repro Med Systems, Inc. (“Manufacturer”) warrants the 

FreedomEdge® syringe driver to be free from defects in materials and workmanship 

under normal use.  Warranty is limited to Original Purchaser and covers the 

FreedomEdge® 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 syringe driver 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 syringe 

driver, 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 FreedomEdge® using RMS accessories to ensure that the 

FreedomEdge® operates in accordance with published specification standards.  If 

non-RMS accessories are used in conjunction with the FreedomEdge®, RMS does not 

represent that the FreedomEdge® will operate in accordance with published 

specification standards.  The FreedomEdge® warranty does not cover third-party 

products or accessories.

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 syringe driver. 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 syringe driver 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.

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Summary of Contents for Freedom Edge

Page 1: ... Driver Syringe Loading and Removal Instructions Selected Flow Rates vs Time SubQ Infusion Instructions Antibiotics Infusion Instructions Troubleshooting Care and Maintenance Testing Accuracy FreedomEdge Flow Profile Technical Specifications Selected Flow Rate Combinations Warranty Information Definition of Symbols 2 2 3 4 4 5 5 6 7 7 9 11 12 13 14 14 15 17 18 Instructions For Use ...

Page 2: ...p Freedom Syringe Driver Infusion System ICFSDIS which includes the FREEDOM60 and FreedomEdge syringe drivers is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home hospital or ambulatory settings when administered according to the approved biologic or drug product labeling The ICFSDIS is specifically indicated for the subcutaneous infusion of the following...

Page 3: ...et 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 Carefully inspect the FreedomEdge Syringe Driver before use Verify its condition and test If the syringe driver is believed to not be operat...

Page 4: ... with PART END CAP END CAP LUER DISC The part numbers for the RMS Precision Flow Rate Tubing represent the target flow rate values for non viscous solutions up to F120 e g most antibiotics For part numbers F180 and higher and all tubing for viscous solutions the part numbers represent the median free flow values which are used in calculations to determine the actual flow rate delivered Part Res Vo...

Page 5: ... the syringe driver RMS Precision Flow Rate Tubing sets are always measured to flow specification during manufacture and will deliver the appropriate flow rate under controlled conditions Testing the FreedomEdge Syringe Driver Part F10050 For Larger Volume Infusions The FreedomEdge offers all the performance and technology of the FREEDOM60 in a design for 20ml and 30ml syringes For larger volumes ...

Page 6: ...o the syringe locater 5 Seat the luer disc inside the syringe driver nose so that the syringe is firmly attached inside the syringe driver Note You can test proper fit by gently tugging on the syringe It will stay in place if properly attached After the infusion is complete open the syringe driver 1 Remove the empty syringe by gently pushing it back to disengage the nose 2 Lift the syringe up out ...

Page 7: ...ch Syringe Tubing Needles 1 Wash Hands Prepare and PrimeTubing Verify that you are using the correct tubing and needle sets recommended by your healthcare provider and prescribed by your doctor 3 Verify Tubing Needles Wash your hands thoroughly and if required put on disposable gloves Be sure the product is at room temperature before you begin filling syringe with your required dose Refer to the m...

Page 8: ... from step 5 of Prepare section 1 Close Syringe Driver Starting Infusion Start the infusion by closing the syringe driver The infusion will begin immediately Note To pause infusion simply open the syringe driver To continue the infusion re close the top lid When closing the syringe driver make sure that the top lid is fully extended and aligns with the bottom portion 2 Remove Syringe Remove the em...

Page 9: ...the cap on the RMS Precision tubing set When medication starts to drip tighten the cap on the tubing Grasp the syringe and gently press down with steady pressure 1 Clean Valve 2 Attach Flush 3 Open Clamp 4 Flush Open the clamp on the access catheter and or extension set Follow your providers instructions to dis infect your valve using an alcohol pad or disinfection cap Avoid touching the disinfect...

Page 10: ...inge locator to help 3 seat the luer disc into nose of the syringe driver The syringe should sit in front of the locator 1 To open confirm that the FreedomEdge is fully extended 2 Then open syringe driver fully by lifting top cover 1 Clamp 2 Open Syringe Driver After Infusion is Complete When syringe is completely empty 3 Detach Tubing 4 Flush Clamp 5 Remove Syringe Repeat Flush steps and if in st...

Page 11: ...g has been connected to an approved syringe and that the disc is seated properly inside the nose of the syringe driver 3 Make sure the flange shape of the syringe is correctly seated into the shape of the syringe locator No flow Open and close the lid to ensure the syringe pusher slides freely and does not bind Make sure the slide clamp is unclamped and has not been used for an extensive period of...

Page 12: ...are thoroughly quality tested to high standards to guarantee flow rate accuracy and appropriate flow rate delivery under controlled conditions Cleaning Clean only those areas that are exposed and external No attempt should be made to clean any part of the syringe driver that is not easily accessible Wipe the outside surface with warm water and detergent or use any surface disinfectant compatible w...

Page 13: ...g 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 FreedomEdge syringe driver testing is based on ANSI AAMI National Standard ID 26 1992 Infusion Devices August 24 1992 Labeled Flow Rate Bench Rated Flow Rate Test Range F60 60ml hr 72ml hr 60 84ml hr F120 120ml hr 134ml hr 115 15...

Page 14: ...pressure 15psi peak 13 5psi nominal 20ml reservoir Height sensitivity 3 per 12 30cm Flow rate data recorded at 21 C using 20ml 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 temperature is approximately linear and would vary from 20 at...

Page 15: ...Flow rate site ml hr Hizentra with FreedomEdge with 30ml syringe Drug volume ml Flow Tube High Flo Set Flow Rate Total ml hr Time NOTES Vol site ml Note 1 Based on combining elements as written in Theory and Measurement of Fluid Flow Rates in the Freedom system Other combinations available per request Note 2 24 G needles are not needed for performance up to 24 08 ml hr for Hizentra Syringe Driver ...

Page 16: ...eedomEdge with 30ml ml syringe Cuvitru with FreedomEdge with 20ml ml syringe Drug volume ml Flow Tube High Flo Set Flow Rate Total ml hr Flow rate site ml hr Vol site ml Time NOTES Note that the following tables are only for the subcutaneous use of the immunoglobulin listed 20 F45 RMS1 2609 14 2 14 2 20 1 24 Patients under40kg Initial 60 F120 RMS2 2609 39 8 19 9 30 1 30 Patients over40kg Initial 1...

Page 17: ...the FreedomEdge RMS does not represent that the FreedomEdge will operate in accordance with published specification standards The FreedomEdge warranty does not cover third party products or accessories 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 ...

Page 18: ...eement shall not extend to special indirect or consequential damages The syringe driver can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the syringe driver for a particular medical treatment All recommendations information and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reliable b...

Page 19: ...English 19 of 20 ...

Page 20: ...dicalproducts com The FreedomEdge Syringe Infusion System FREEDOM60 Syringe Infusion System and RMS Precision Flow Rate Tubing are registered trademarks of RMS Medical Products and are compliant with Medical Device Directive 93 42 EEC RMS Medical Products is ISO 13485 certified 2017 RMS Medical Products All Rights Reserved ...

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