Each FreedomEdge includes a travel pouch and user manual. Syringes for use with the FreedomEdge: • Becton Dickinson & Co. BD Luer-Lok 20 ml (US Ref.
Instructions For Use
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 FreedomEdge Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 FreedomEdge Product Line. . . . . . . . . . . . . . . . . . . . . . . . . 4 Syringes for Use with FreedomEdge . . . . . . . . . . . . . . . 4 Preoperation Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Instructions for Subcutaneous (SQ) Infusions . . . . . . . 5 Instructions for Intravenous (IV) Infusions . . . . . . . . . . . 7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Residual Volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Selected Flow Rate Combinations . . . . . . . . . . . . . . . . . . 12 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Definition of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
KORU Medical Systems | 24 Carpenter Road Chester, NY 10918 USA 800-624-9600 toll free | 845-469-2042 local | korumedical.com
Introduction:
The FreedomEdge® Syringe Infusion System is portable and easy to use, requiring no batteries or electricity. It starts to operate when the syringe driver is closed. KORU Precision Flow Rate TubingTM sets are used to control the flow rate. The FreedomEdge operates at a constant pressure, which automatically decreases the flow rate if there is an increase in resistance during the delivery. The system will find balance, known as Dynamic Equilibrium (or DynEQ®), 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 return. The FreedomEdge also eliminates concerns of a bolus, overflow, overdose or runaway infusion.
Indications for Use:
The Freedom Integrated Syringe Infusion System, which includes the FreedomEdge syringe driver, 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 Freedom System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®). The Freedom System is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin. The FreedomEdge Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830) or BD® 30 ml syringe (US Reference number: 302832).
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Caution:
· Use the FreedomEdge® Syringe Infusion System only for the patient for whom the device is prescribed and only for its intended use.
· Use only Freedom System accessories manufactured by KORU Medical Systems. Use of off-brand products may result in unknown flow rates.
· Directly connecting extension tubing or HIgH-Flo needle sets (without the luer disc) to the syringe may cause internal damage to the syringe driver.
· Use only BD® 20 ml or 30 ml syringes with the FreedomEdge. · Using the same tubing set, BD 30 ml syringes will have slightly slower flow rates
and slightly increased delivery times versus BD 20 ml syringes. · Before use, carefully inspect the tubing and needle set packaging. Do not use the
set if the package is opened or damaged. · Do not re-sterilize tubing or needle sets. · The slide clamp included on the Precision tubing and HIgH-Flo needle sets
should only be used in the case of an emergency, to stop flow immediately. Use of the slide clamp may cause damage to the tubing and can affect the intended flow rate. · Carefully inspect the FreedomEdge before use. Discontinue use of a syringe driver that has been damaged, exposed to severe impact, or which fails to operate properly. · The FreedomEdge 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 syringe driver is not suitable for use with medication where delay or under-infusion could result in serious injury. · If the syringe driver is submerged in any fluid, discontinue use and call your healthcare provider for a replacement. · Do not autoclave the FreedomEdge. · Federal law (USA) restricts this device to sale by or on the order of a physician. · Freedom infusion components (Precision tubing and HIgH-Flo needle sets) should not be assembled prior to shipping. · The FreedomEdge Syringe Infusion System is not intended for blood transfusions.
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FreedomEdge® Diagram:
Fully Closed
PROGRESS WINDOW
Extended
TOP LID
20 ml or 30 ml LUER BD® SYRINGE CRADLE
DRIVER NOSE
SYRINGE LOCATOR
SYRINGE PUSHER
Fully Extended
and Open
LUER DISC
ARMS
(FEMALE) END OF FLOW RATE TUBING
MALE END OF FLOW RATE TUBING
EMERGENCY SLIDE CLAMP
Product Line:
Each FreedomEdge includes a travel pouch and user manual.
Product FreedomEdge Syringe Driver Replacement Travel Pouch
Part # F10020 347400
Syringes for use with the FreedomEdge:
· Becton Dickinson & Co. BD® Luer-Lok® 20 ml (US Ref. number: 302830) · Becton Dickinson & Co. BD® Luer-Lok® 30 ml (US Ref. number: 302832)
Preoperation Instructions:
1. Examine the inside to ensure it is free of debris or damage. 2. Make sure the syringe locator moves freely by sliding it up and
down with your finger.
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Instructions for Subcutaneous Infusions:
Ensure medication is intended to be administered subcutaneously.
Prepare and Prime Tubing:
1 Wash Hands
2 Verify Tubing & Needles 3 Fill Syringe
Gather supplies. Wash your hands thoroughly and, if required, put on disposable gloves.
Verify that you are using the correct Precision tubing and HIgH-Flo needle sets recommended and/or prescribed by your healthcare provider.
Be sure the medication is at room temperature before filling the BD® 20 or 30 ml syringe with your required dose. Refer to the drug manufacturer's instructions or ask your healthcare provider for detailed filling instructions.
4 Attach Syringe, Tubing & Needles
5 Prime Needle Set
1. Remove the sterile cap from the luer disc end of the Precision tubing set and connect to syringe. 2. Remove sterile caps from opposite end of tubing set and HIgH-Flo needle set and connect, using care not to contaminate ends.
1. Grasp the syringe and gently press down with steady pressure. 2. Watch the tubing fill and try to stop the flow about 2" short of the needle(s). NOTE: To minimize site irritation, it is recommended to insert needles dry.
Insert Needles/Check for Blood Return:
6 Prepare Sites 7 Insert
8 Secure
9 Pull Back
Select your site(s) and Pinch the skin and Secure the needle(s) Remove the syringe
cleanse with alcohol insert each needle by placing adhesive from the syringe driver.
(if advised by provider) into the subcutaneous dressing in the center Check for blood return
and let dry. Carefully tissue at a 90° angle. of the needle butterfly. by gently pulling back
remove the shield from
Smooth it outward
on the syringe plunger.
the needle tip, with care
over skin.
not to touch the needle.
10 Watch
1. Watch to make sure no red/pink appears in tubing near your sites.
2. If blood return exists, clamp the flow to the sites and call your healthcare provider 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 5.
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Prepare FreedomEdge® and Begin Infusion:
11 Open Syringe Driver
1. Pull firmly to fully extend the syringe driver.
2. Then, open the syringe driver fully by lifting the top cover.
12 Load Syringe
1. With syringe gradations facing up, push the syringe against the syringe locater. 2. Seat the syringe flange into the syringe locater. 3. Verify that the Precision tubing (with the luer disc) is connected to syringe. Seat the luer disc inside the syringe driver nose so that the syringe is firmly attached inside the syringe driver.
NOTE: You should not need to use significant force to load or remove the syringe. You can test proper fit by gently tugging on the syringe. It will stay in place if properly attached.
13 Close Syringe Driver
To start the infusion, close the top lid. The infusion will begin immediately. Periodically monitor the infusion by checking the progress window, until syringe is empty.
To pause infusion: Simply open the syringe driver. To continue, re-close the top lid.
NOTE: When closing the syringe driver, make sure that the top lid is fully extended and aligns with the bottom portion.
If using multiple syringes: Once the first syringe is empty, open the syringe driver to turn off. Remove the syringe and connect additional syringe to the luer disc end of the Precision tubing set. Close the syringe driver to continue infusion.
End of Infusion: (When syringe is completely empty)
14 Open Syringe Driver 15 Remove Syringe
16 Remove Needles
Turn the syringe driver OFF Remove the empty syringe. by opening the top lid.
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Holding the needle in place, peel back the surrounding adhesive dressing. Remove the needle in a straight motion. Close the wings over the needle and snap shut. Remove set from the syringe. Discard all sharps and biologics as required.
Instructions for Intravenous Infusions:
Ensure medication is intended to be administered intravenously.
Prepare and Prime Tubing:
1 Wash Hands
2 Fill Syringe
3 Attach Tubing
Gather supplies. Wash your hands thoroughly and, if required, put on disposable gloves.
4 Loosen Cap
Fill the BD® 20 or 30 ml syringe(s) with your required dose. Refer to the drug manufacturer's instructions or ask your healthcare provider for detailed filling instructions.
5 Push Plunger
Verify that you are using the correct Precision tubing set recommended and/or prescribed by your healthcare provider. Remove sterile cap from luer disc end of the Precision tubing set and connect to the syringe.
Watch for Drip 6 & Tighten Cap
Loosen the cap on the Precision tubing set.
Grasp the syringe, gently press down with steady pressure.
When medication starts to drip, tighten the cap on the Precision tubing set.
Flush: Always follow your healthcare provider's protocol.
7 Use SASH Technique
Saline Flush
Ensure patency of the line and clear the line of residual medication
Administer
Administer the medication (follow Infuse Dose Steps 8 - 11 on the next page)
Saline Flush
Ensure patency of the line and clear the line of residual medication
Heparin (If required for patency)
Minimize the potential of a blood clot forming inside the central line lumen
· Cleanse needleless connector with alcohol - 15 second scrub and allow to air dry. · Aspirate for blood return to ensure line patency before each access.
References: Hadaway L. Technology of flushing vascular access devices. Journal of Infusion Nursing. 29(3):129145, 2006.
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Infuse Dose: 8 Connect
9 Open FreedomEdge®
Uncap the Precision tubing set. Turning clockwise, connect the Precision tubing to the catheter end or needle-free connector.
1. To open, confirm that the FreedomEdge is fully extended. 2. Then, open syringe driver fully by lifting top cover.
10 Load Medication Syringe
NOTE: You should not need to use significant force to load or remove the syringe. You can test proper fit by gently tugging on the syringe. It will stay in place if properly attached.
1. With syringe gradations facing up, push the syringe against the syringe locater. 2. Seat the syringe flange into the syringe locater. 3. Verify that the Precision tubing (with the luer disc) is connected to syringe. Seat the luer disc inside the syringe driver nose so that the syringe is firmly attached inside the syringe driver.
11 Close Syringe Driver
Check that all clamps are open. To start the infusion, close the top lid. The infusion will begin immediately. Periodically monitor the infusion by checking the progress window, until syringe is empty.
To pause infusion: Simply open the syringe driver. To continue, re-close the top lid.
NOTE: When closing the syringe driver, make sure that the top lid is fully extended and aligns with the bottom portion.
If using multiple syringes: Once the first syringe is empty, open the syringe driver to turn off. Remove the syringe and connect additional syringe to the luer disc end of the Precision tubing set. Close the syringe driver to continue infusion.
End of Infusion: (When syringe is completely empty)
12 Open Syringe Driver
13 Detach Tubing
If needed, close clamp on the catheter. Turn the syringe driver OFF by opening the top lid.
Disconnect the Precision tubing set from the catheter or needle-free connector.
14 Flush
Refer to Step 7 on the previous page for SASH technique and follow your healthcare provider's instructions.
15 Remove Syringe
Open the syringe driver and remove the empty syringe. Discard any biologics as required.
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Troubleshooting:
If the suggestions in this section do not solve your problem, or if problems persist, discontinue use and consult your healthcare provider.
Syringe will not load or remove from syringe driver:
NOTE: You should not need to use significant force to load or remove a syringe.
· Make sure the syringe driver is fully open, and that nothing is blocking the syringe locator.
· Confirm you are not filling the syringe to more than 30 ml, or using a syringe larger than 30 ml.
· If you still have difficulty, use one hand to slide the syringe locator all the way back, then place the syringe.
Syringe will not stay inside in the syringe driver:
· Make sure you are using the proprietary Precision Flow Rate TubingTM sets and that the luer disc end of the tubing has been connected to a BD® 20 or 30 ml syringe.
· Make sure the luer disc is seated properly in the nose of the syringe driver.
· Make sure the flange shape of the syringe is correctly seated into the shape of the syringe locator.
syringe locator
No flow:
syringe ange
· Open and close the lid to ensure the syringe pusher slides freely and does not bind.
· Make sure all the slide clamps are unclamped. If vascular access device is being used, make sure its clamps, if any, are open.
· Use sterile procedures to disconnect the tubing set from the needle set or catheter and check for medication drip.
· If infusing subcutaneously and the medication does not drip from the tubing set, replace the tubing as it may be damaged.
· If infusing intravenously, check the catheter patency.
Slow flow:
· Verify that you are using the proper tubing.
· Verify that you are using the proper syringe. 30 ml syringes will flow approx. 73% of the rate of a 20 ml syringe (e.g. 120ml/hr tubing will flow at approx. 87.6ml/hr).
· If the slide clamp has been used, the tubing may be damaged.
· For subcutaneous infusions:
· Administration may be slow based on how well medication is absorbed through the tissue. If it is your first infusion, it may take longer than expected because your body may need to adjust.
· Avoid placing needles on top of scar tissue or muscle.
· It is possible you may need more sites, longer needles or a faster flow rate tubing set. Talk to your healthcare provider.
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Stopping the flow quickly · The syringe driver is designed to maintain pressure during and after the infusion to prevent blood/drug backflow. · To stop the flow, fully open the lid to relieve pressure from the syringe plunger. · The slide clamp can be used in the case of an emergency, when necessary to immediately stop the flow.
Care and Maintenance:
The FreedomEdge® does not require any preventative maintenance. When used in combination with Precision Flow Rate TubingTM, KORU Freedom works as a system. This means the tubing determines the flow rate, not the syringe driver; therefore no calibration is needed.
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 such as household bleach or hydrogen peroxide. Avoid excessive use of alcohol or alcohol containing compounds, as these tend to make ABS plastic brittle and degrade the product labeling. Wipe again with clean water to rinse.
Storage The FreedomEdge syringe driver is recommended to be stored in a cool, dry place at room temperature (approximately 16-30°C or 61-86°F).
Testing Flow Accuracy (if required by your local protocol) 1. Remove all air from a new BD® 20 ml syringe with sterile water. Do NOT use a 30 ml syringe for this test. 2. Completely fill with 20 ml of sterile water. 3. Attach a sterile F120 Precision Flow Rate Tubing set to the syringe. 4. Remove all air from the tubing set. 5. Load the syringe into the syringe driver. 6. Using a stop watch or similar time tracking device, start the timer when the top lid of the syringe driver is fully closed (flow will begin). 7. Monitor and stop the timer when 10 ml of water has left the syringe. 8. The elapsed time should fall between 3:50 - 5:11 minutes.
NOTE: If the test results fall outside the range indicated in Step 8, factory refurbishment and testing are available. Please contact KORU Medical Systems at 800-624-9600.
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Technical Specifications:
Syringe Driver: Weight: 12oz (0.34kg) Length: Closed: 9" (229mm)
Extended: 11.75" (299mm) Width: 3.25" (83mm) Height: 1.5" (38mm)
System: Accuracy: +/- 15%
Syringe: Reservoir volume: 20/30 ml (BD® brand syringes)
Residual Volumes - Precision Tubing and HIgH-Flo Needle Sets:
Item # F0.5 F1 F2 F3 F3.8 F5 F8
Res. Vol. 0.09 ml 0.08 ml 0.10 ml 0.09 ml 0.09 ml 0.08 ml 0.08 ml
Item # F10 F15 F30 F45 F60
F120 F180
Res. Vol. 0.14 ml 0.11 ml 0.13 ml 0.11 ml 0.14 ml 0.16 ml 0.13 ml
Item # F275 F420 F500 F600 F900 F1200
F2400
Res. Vol. 0.11 ml 0.10 ml 0.09 ml 0.09 ml 0.08 ml 0.13 ml 0.15 ml
26 Gauge Sets Residual Volumes Needles Item Number Res. Vol.
1 needle
RMS126XX
0.1 ml
2 needles
RMS226XX
0.2 ml
3 needles
RMS326XX
0.3 ml
4 needles
RMS426XX
0.4 ml
5 needles
RMS526XX
0.5 ml
6 needles
RMS626XX
0.6 ml
26 Gauge with Y-Connector
7 needles RMS426XX + RMS326XX 0.9 ml
8 needles RMS426XX + RMS426XX 1.0 ml
24 Gauge Sets Residual Volumes
Needles Item Number Res. Vol.
1 needle 2 needles
RMS124XX RMS224XX
0.4 ml 0.7 ml
3 needles 4 needles
RMS324XX RMS424XX
1.1 ml 1.4 ml
KORU Related Options
Product Code LRVY (Low Residual Volume Y-Connector) FEXT (24" Extension Set)
Res. Vol. 0.14 ml 0.4 ml
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Selected Flow Rate Combinations
Select Combinations of Flow Rates with HIgH-Flo Subcutaneous Safety Needle SetsTM (Standard 26G and 24G) when used in combination with Precision Flow Rate TubingTM for use with Hizentra, Cuvitru, and Gammagard Liquid.
NOTE: The following tables are only for the subcutaneous use of the immunoglobulin listed.
Drug Flow Rate volume (ml) Tubing
10
F120
Hizentra FreedomEdge® with 20 ml syringe
HIgH-Flo Total Flow Flow rate/site Vol/site
Needle Set* Rate (ml/hr) (ml/hr)
(ml)
Time
NOTES:
RMS12609
8.2
8.2
10
1:12 Suggested start Peds
10
F180 RMS12609
10.5
10.5
10
0:57 Suggested start Peds
20
F275 RMS22609
17.1
8.5
10
1:10 Suggested start Peds
20
F600 RMS22609
29.6
14.8
10
0:40 Suggested start Peds
40
F600 RMS32609
33.9
11.3
13.3 1:10 Suggested start Adult
40
F900 RMS32609
44.3
14.8
13.3 0:54 Suggested start Adult
60
F900 RMS42609
49
50
F2400 RMS32609
72.2
12.3
15
1:13 Suggested start Adult
24.1
16.67 0:41 6th Infusion of biologic and beyond
100
F2400 RMS42609
85.5
21.4
25
1:10
6th Infusion of biologic and beyond (NEEDS TWO SYRINGES)
Hizentra - with FreedomEdge® with 30 ml syringe
20
F600 RMS22609
22.5
30
F900 RMS22609
28.3
11.2
10
0:53 Suggested start Peds
14.2
15
1:03 Suggested start Adult
30
F2400 RMS22609
41.9
20.9
15
0:42 6th Infusion of biologic and beyond
Cuvitru with FreedomEdge® with 20 ml syringe
Drug Flow Rate HIgH-Flo Total Flow Flow rate/site Vol/site
volume (ml) Tubing Needle Set* Rate (ml/hr) (ml/hr)
(ml)
Time
NOTES:
10
F275 RMS12609
12.1
20
F275 RMS12609
12.1
12.1
10
0:49 1st Two Infusions patients under 40kg
12.1
20 1:39 1st Two Infusions patients under 40kg
20
F600 RMS22609
25.7
12.8
10
0:47 1st Two Infusions patients under 40kg
50
F600 RMS22609
25.7
60
F1200 RMS22609
37.1
12.8
25 1:57 1st Two Infusions patients over 40kg
18.6
30 1:37 Subsequent Infusions
60
F2400 RMS22409
110.5
55.4
30 0:32 Subsequent Infusions
60
F1200 RMS12409
55.3
55.3
60 1:05 Subsequent Infusions
100
F2400 RMS42409
132.8
33.2
25 0:45 Subsequent Infusions
Cuvitru with FreedomEdge® with 30 ml syringe
20
F500 RMS22609
12.9
12.9
20
1:32 1st Two Infusions patients under 40kg
30
F900 RMS22609
24.6
30
F2400 RMS12609
21.2
12.3
15
1:13 1st Two Infusions patients under 40kg
21.2
30 1:24 Maintenance Infusions
30
F1200 RMS12409
42.1
42.1
30 0:42 Maintenance Infusions
Gammagard Liquid with FreedomEdge® with 20 ml syringe
Drug Flow Rate HIgH-Flo Total Flow Flow rate/site Vol/site
volume (ml) Tubing Needle Set* Rate (ml/hr) (ml/hr)
(ml)
Time
NOTES:
20
F45 RMS12609
14.2
14.2
20 1:24 Patients under 40kg (Initial)
60
F120 RMS22609
39.8
19.9
30 1:30 Patients over 40kg (Initial)
100
F420 RMS42609
119.1
29.8
25 0:50 Patients over 40kg (maintenance infusions)
Gammagard Liquid with FreedomEdge® with 20 ml syringe
20
F120 RMS22609
30
15
10 0:40 Patients under 40kg(Initial)
30
F180 RMS22609
39.8
19.9
15 0:45 Patients over 40kg (Initial)
30
F120 RMS12609
27
27
30 1:06 Patients over 40kg (Maintenance)
*HIgH-Flo needle sets: The first number refers to the number of needles, the next two numbers refer to the needle gauge, and the last two numbers refer to the needle length (mm).
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Warranty Information:
This warranty and the rights and obligations hereunder, shall be construed under and governed by the laws of the State of New York, USA.
Limited Warranty: KORU Medical Systems/Repro Med Systems, Inc. ("Manufacturer") warrants the 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-KORU 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.
KORU tests the FreedomEdge using KORU accessories to ensure that the FreedomEdge operates in accordance with published specification standards. If non-KORU accessories are used in conjunction with the FreedomEdge, KORU 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 infusion 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, KORU Medical Systems/Repro Med Systems, Inc., 24 Carpenter Road, Chester, NY 10918, USA. Notice to KORU Medical Systems/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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· Limitations and Exclusions: Repair or replacement of a syringe driver or component part is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply:
· 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.
· 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.
· Manufacturer's liability under this Limited Warranty Agreement 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, but do not constitute warranties.
Definition of symbols:
Caution Consult Instructions For Use Authorized Representative in the European Community Batch Code Quantity Catalog Number Serial Number
Sterilized Using Irradiation
Use by YYYY-MM-DD or YYYY-MM Manufacturer
Do Not Reuse
Do Not Resterilize
Latex Free Do Not Use if Package is Damaged Prescription Only
European Conformity
14
Notes:
15
Manufacturer
KORU Medical Systems 24 Carpenter Road Chester, NY 10918 USA 800·624·9600 toll free 845·469·2042 local
European Representative
MedPass International 95 bis Boulevard Pereire 75017 Paris, France +33 (0)1 42 12 83 30
korumedical.com
The FreedomEdge® and FREEDOM60® Syringe Infusion Systems, Precision Flow Rate TubingTM, HIgH-Flo Subcutaneous Safety Needle SetsTM, and DynEQ® are trademarks of KORU Medical Systems and are compliant with Medical Device Directive 93/42/EEC. All other trademarks are the property of their respective owners. KORU Medical Systems is ISO 13485 certified. ©2020 KORU Medical Systems; All Rights Reserved.
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