RMS FREEDOM60 User manual

Introduction
Indications for Use
Caution
FREEDOM60® Syringe Driver Diagram
FREEDOM60® Product Line
Syringes for Use with FREEDOM60®
Testing FREEDOM60® Syringe Driver
Syringe Loading and Removal Instructions
Selected Flow Rates vs Time
SubQ Infusion Instructions
Antibiotics Infusion Instructions
Troubleshooting
Care and Maintenance
FREEDOM60® Flow Prole
Technical Specications
Selected Flow Rate Combinations
Warranty Information
Denition of Symbols
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Instructions For Use
English 1 of 20

English 2 of 20
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 ow rate.
The FREEDOM60® operates at a constant safe pressure of 13.5psi. The constant
pressure developed in the FREEDOM60® automatically decreases the ow rate if there
is an increase in resistance during the delivery. The system will nd equilibrium
between the increasing resistance and ow rate. It provides constant ow which tends
to inhibit clots, and holds full pressure after an infusion is complete to prevent blood
or drug backow. The FREEDOM60® also eliminates concerns of a bolus, overow,
overdose or runaway infusion.
Indications for Use:
The Integrated Catch-Up 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 uids in the home, hospital,
or ambulatory settings when administered according to the approved biologic or drug
product labeling. The ICFSDIS is specically indicated for the subcutaneous infusion of
the following human plasma-derived immunoglobulins when used according to the
FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human)
20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin
Infusion (Human) 10% (manufactured by Shire); and Cuvitru Immune Globulin Infusion
(Human) 20% (manufactured by Shire). The ICFSDIS is specically 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
(model no. 302830/301031) or BD 30 ml (model no. 301033) syringe. The FREEDOM60®
Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no.
309653).

English 3 of 20
Caution:
• Use the FREEDOM60® Syringe Infusion System only for the patient for whom the device is
prescribed and only for its intended use.
• In order to achieve specic and repeatable ow rate performance with the Freedom Syringe
Infusion Systems’ unique constant force mechanism, use only Freedom System accessories
manufactured by RMS Medical Products. Directly connecting extension tubing or administration
set (without the luer disc) will cause the syringe to eject from the syringe driver and eventually
cause internal damage to it. Use of any other ow control accessory may also cause over delivery
of uids or medication to the patient. For use with subcutaneous immune globulin products, use
only RMS ow control devices and HIgH-Flo needle sets, as use of generic products may result in
unknown ow rates and additional site complications such as pain, swelling and redness.
•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.
• Overuse of the slide clamp or storing tubing sets with the slide clamp engaged for long periods of
time* may damage the tubing and aect the infusion rate.
•The black tab that pushes on the syringe plunger operates under high force. Do not place ngers
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® Syringe Driver before use. Verify its condition and test. If
repeated testing indicates the syringe driver is not operating properly or at the appropriate rate of
ow, immediately discontinue use.
• Discontinue use of a syringe driver that has been damaged, exposed to severe impact, or which
has failed to test properly.
•Do not attempt to open the syringe driver 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 rst turning the
syringe driver OFF and fully winding the large knob clockwise until the black tab has reached the
end of its track.
•The FREEDOM60® Syringe Infusion System does not have an alarm, therefore no alarm will sound
if an interruption to ow 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.
• Discontinue use of a syringe driver that has been submerged in uid. If any uid is allowed to
enter the syringe driver, it should be replaced immediately.
•Do not autoclave the FREEDOM60®. It will melt the ABS plastic and damage the syringe driver.
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• Priming and shipping of tubing sets, packaged at temperatures below freezing, is not
recommended. This may damage the tubing.
• The FREEDOM60® Syringe Infusion System is not intended for blood transfusions.
*Generally greater than 2 hours.

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END OF TRACK
(TRACK END)
LARGE KNOB
(WIND UP KNOB)
SYRINGE
PLUNGER
DRIVER NOSE
LUER DISC END OF
FLOW RATE TUBING
MALE END OF
FLOW RATE TUBING
SYRINGE SHIELD
BLACK TAB
ON/OFF SWITCH
SLIDE CLAMP
Patent No. D398,053
FREEDOM60® Syringe Driver Diagram:
FREEDOM60® Product Line:
Each FREEDOM60® Syringe Infusion System includes a travel pouch and user manual.
Product
Part #
FREEDOM60® Syringe Driver
F10050
Replacement Travel Pouch - black
F10090
Zebra Print Travel Pouch - pattern F10080
The part numbers for the RMS Precision Flow Rate Tubing™ represent the target ow 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 ow values,
which are used in calculations to determine the actual ow rate delivered.
RMS Precision Flow Rate Tubing™ (case of 50)
Part #Res. Vol.Part #Res. Vol.
F60
F120
F180
F275
F420
F500
F600
F900
F1200
F2400
0.14
0.16
0.13
0.11
0.10
0.09
0.09
0.08
0.13
0.15
F0.5
F1
F2
F3
F3.8
F5
F8
F10
F15
F30
F45
0.09
0.08
0.10
0.09
0.09
0.08
0.08
0.14
0.11
0.13
0.11

English 5 of 20
Part #: F10020
For Smaller Volume Infusions:
The FREEDOM60® is designed to accommodate 60ml syringes. For smaller volumes,
the FreedomEdge® accommodates both 20ml and 30ml syringes.
Syringes for use with the FREEDOM60®:
• Becton Dickinson & Co. BD® Luer-Lok® 60ml (US Reference #309653;
EU Reference #300865)
Testing the FREEDOM60® Syringe Driver:
1. Examine the inside of the syringe shield and ensure it is free of debris or
contamination.
2. Make sure that the syringe driver’s on/o 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 syringe driver ON (–) and watch that the tab moves smoothly
along the full length of its track; listen for the following sounds:
• a ‘click’ as the driver is turned ON (–)
• a ‘whirring’ 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 nger.

English 6 of 20
Syringe Loading and Removal Instructions:
To load a syringe: To remove a syringe:
Make sure that the syringe
driver’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, wind the
large knob clockwise.
With the tubing attached and
gradations facing up, load the
pre-lled syringe, plunger rst,
into the syringe shield. Make
sure the tubing luer disc is fully
seated in the driver’s nose.
After the infusion is complete,
turn the syringe driver OFF
and wind the large knob
clockwise until the black tab is
at the end of its track. Remove
the empty syringe by gently
pushing it back to disengage
the nose, then lifting it up out
of the syringe driver.
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.
Note: For assistance in determining which ow rate tubing set to use, please contact
RMS Medical Products at 800-624-9600.
Selected Flow Rates vs Time:
1ml/hr 2ml/hr 30ml/hr 45ml/hr 60ml/hr 120ml/hr
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.
Syringe
Volume
Flow Rate vs Time Chart

English 7 of 20
Prepare the FREEDOM60® Syringe Driver:
1 Wash Hands
4 Attach Tubing 6 Insert Syringe5 Check Black Tab
2 Fill Syringe
Prime Tubing:
For SubQ Infusions, follow these instructions:
3 Verify Tubing & Needles
Verify that you are using the
correct tubing and needle sets
recommended by your health-
care provider and prescribed
by your doctor.
Be sure the product is at room
temperature before you begin
lling the 60 ml syringe with
your required dose. Refer to
the manufacturer's instructions
or ask your provider for more
detailed lling instructions.
Gather supplies. Wash
your hands thoroughly
and, if required, put on
disposable gloves.
1. Remove sterile cap from the
luer disc end of the RMS Precision
tubing set and connect to syringe.
For SubQ only:
2. Remove sterile caps from
opposite end of tubing set and
HIgH·Flo needle set and connect,
using care not to contaminate ends.
Make sure the syringe
driver is o and the black
tab inside the clear 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.
With syringe gradations
facing up,
1. load the syringe and its
tubing into the syringe driver.
2. Make sure the luer disc is
fully seated in the driver’s nose.
1 Turn ON 2 Turn OFF 3 Wind Back
1. Turn the
syringe driver’s
ON/OFF
switch to the
ON position
to prime (ll)
the tubing,
2.
but try to
stop the ow
about 2”short
of the needle(s).
To stop ow to the
needle(s), turn the
syringe driver’s
ON/OFF switch to
the OFF position.
Wind the large knob clockwise until
the black tab is clearly not touching
the syringe. This will release pressure
on the plunger and stop the ow

English 8 of 20
Insert Needles/Check for Blood Return:
1 Prepare Sites 2 Insert 3 Secure 4 Pull Back
5 Watch
Begin Infusion:
1 Insert Syringe 2 Turn ON
After Infusion is Complete:
1 Turn OFF 2 Remove Needle(s) 3 Wind Back 4 Remove Syringe
1. Watch to make sure no red/pink appears in tubing near your sites.
2. If blood return exists, clamp the ow to that site 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 6 of Prepare section.
Select your site(s),
cleanse with alcohol
and let dry. Carefully
remove shield from the
needle tip, with care
not to touch the needle.
Pinch the skin and
insert each needle
into the subcutaneous
tissue at a 90˚ angle.
Secure needle(s)
with adhesive
dressing.
Remove the syringe
from the syringe driver.
Check for blood return
by gently pulling back
on the syringe plunger.
With syringe
gradations facing
up, insert the
syringe back into
the syringe driver.
Turn the syringe
driver’s ON/OFF
switch to the
ON position.
Once infusion is
complete, turn the
syringe driver’s
ON/OFF switch to
the OFF position.
Hold needle in place
and peel back any ad-
hesive/dressing around
it. Remove needle(s) in
a straight motion,
opposite the direction
you inserted it.
Wind the large knob
until the black tab is
at the end of its track.
1. Pull syringe away from
the syringe driver’s nose
and, 2. remove syringe
from the syringe driver.
Cleanse each site and
cover with a bandage.
Discard all sharps and
biologics as required.

English 9 of 20
For Antibiotics Infusions, follow these instructions:
1 Turn ON 2 Loosen Cap
4 Turn OFF 5 Wind Knob
Watch for Drip
& Tighten Cap3
Prime Tubing:
Flush: Always follow your provider’s protocol.
1 Clean Valve 2 Attach Flush
3 Open Clamp 4 Flush
Turn the syringe driver’s ON/OFF
switch to the ON position.
Loosen the cap on the RMS
Precision tubing set.
Turn the syringe driver’s ON/OFF
switch to the ON position.
Turn the syringe driver’s ON/OFF
switch to the ON position.
When medication starts to
drip, tighten the cap on
the tubing.
Follow your providers
instructions to dis-
infect your valve using
an alcohol pad or dis-
infection cap. Avoid
touching disinfected
opening of the valve.
Connect the
syringe directly
into the valve
and turn
clockwise.
Open the clamp
on the access
catheter and/or
extension set.
Flush with a
gentle push
and pause
method.

English 10 of 20
Clamp the access catheter
and/or extension set.
Turn the syringe driver’s
ON/OFF switch to the
OFF position.
Disconnect the RMS Precision
tubing set and attach sterile
protection cap to set.
Uncap the RMS Precision tubing set.
Turning clockwise, connect the RMS
Precision tubing to the valve.
Check that all clamps are
open. Turn the syringe driver’s
ON/OFF switch to the ON
position to begin the infusion.
Periodically check
that the syringe driver
is working by seeing
that the syringe
plunger is moving.
1 Connect 2 Turn ON
3 Check Infusion
Infuse Dose:
1 Clamp 2 Turn OFF
After Infusion is Complete:
(When syringe is completely empty)
3 Detach Tubing
4 Flush & Clamp 5 Wind Back 6 Remove Syringe
Wind the large knob
until the black tab is
at the end of its track.
1. Pull syringe away from
the syringe driver’s nose
and,
2. remove syringe
from the syringe driver.
Repeat Flush steps, and if
instructed by nurse - ush
with Heparin. Clamp
when done.

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 syringe driver:
• You will never need to use force to load or remove a syringe.
• Make sure the syringe driver 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.
• Verify that you are using the proper BD® brand 60ml syringe.
Syringe will not stay inside in the syringe driver:
• Make sure you are using the proprietary RMS Precision Flow Rate 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 syringe driver.
No flow:
• Assure that the syringe driver is in the ON (–) position.
• Make sure the slide clamp is unclamped, and 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 syringe driver 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, catheter, or any fluid path accessories such as a needle-free
adapter.
Slow flow:
• 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 (1ml/min).
For 120ml/hr tubing, the plunger should move 10ml in 5 minutes (2ml/min).
Flow may continue even when the syringe driver is turned OFF:
• This is a normal function of the driver. The syringe driver is designed to
maintain pressure during and after the infusion to prevent blood/drug
backflow.
• To stop the flow turn the driver 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 using the slide clamp to
immediately stop the flow only in the case of an emergency. Overuse can
damage the tubing.
English 11 of 20

Medication (5ml or less) left in the syringe
• Verify that you are using the proper BD® brand 60ml syringe.
Do not use Terumo syringes.
Medication (5ml or less) left in the syringe
• Verify that you are using the proper BD® brand 60ml syringe.
Do not use Terumo syringes.
Medication (5ml or less) left in the syringe
• Verify that you are using the proper BD® brand 60ml syringe.
Do not use Terumo syringes.
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 syringe
driver; therefore our syringe driver 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 con-
trolled 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. Discontinue use
of a syringe driver 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 com-
pounds, 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:
The FREEDOM60® syringe driver 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):
1. Fill a new syringe with 60ml of sterile water
2. Remove all air from the syringe
3. Attach a sterile RMS Precision Flow Rate Tubing™ set to the syringe
4. Remove all air from the tubing set
5. Load the syringe into the driver and turn it ON (–)
6. Monitor the syringe readings and elapsed time to derive an approximate
flow rate
English 12 of 20

English 13 of 20
If test results in the range indicated cannot be approximated under bench testing
conditions, factory refurbishment and full certication 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, 1992.
7b. Test Range: To assure consistent test results, keep syringe driver 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 drivers 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® syringe
driver testing is based on ANSI/AAMI National Standard, ID 26-1992, Infusion Devices,
August 24, 1992.
7a. Bench-Rated Flow Rate: The FREEDOM60® syringe driver 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 circumstances.
7. Compare your test results to the range of test rates listed in the table below:
60ml/hr Tubing
120 ml/hr Tubing
Bench Test Rate
72ml/hr
134ml/hr
Less Clinical Eects
Catheter Gauge (20G PICC)
-7ml/hr
-8ml/hr
Fluid Viscosity
-2ml/hr
-3ml/hr
Venous Pressure
-3ml/hr
-3ml/hr
Label Flow Rate
60ml/hr
120ml/hr
Labeled Flow Rate Bench-Rated Flow Rate Test Range
60ml/hr
72ml/hr
60-84ml/hr
120ml/hr
134 ml/hr
115-153ml/hr

FREEDOM60® Flow Profile:
The FREEDOM60® flow profile shows that the flow rate is consistent throughout the
delivery of medication.
*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.
Technical Specifications:
System
Reservoir volume: 60ml (maximum)
Residual volume: <0.4ml
Flow rate accuracy: ± 8%*
Operating pressure: 15psi (peak) 13.5psi (nominal)
Height sensitivity: ± 3% per 12” (30cm)
Constant force mechanism: ± 3%
FREEDOM60®Flow Rate vs. Time
Fluid: HO • Fluid Volume: 60ml • Tubing Measured:F120 – 120ml/hr
0
20
40
60
80
100
120
140
160
180
0
1
3
4
5
6
8
9
10
11
13
14
15
16
18
19
20
21
23
24
25
26
28
29
30
Time (minutes)
F
low Rate (ml/hr)
English 14 of 20

English 15 of 20
Syringe Driver
Weight: 14oz (0.4kg)
Length: 12” (304mm)
Width: 4.5” (114mm)
Height: 1.6” (41mm)
RMS Precision Flow Rate Tubing™
Length: 6” to 72” (152mm-1829mm)
RMS Precision Flow Rate Tubing™ / Residual Volume (ml)
Part #Res. Vol.Part #Res. Vol.
F60
F120
F180
F275
F420
F500
F600
F900
F1200
F2400
0.14
0.16
0.13
0.11
0.10
0.09
0.09
0.08
0.13
0.15
F0.5
F1
F2
F3
F3.8
F5
F8
F10
F15
F30
F45
0.09
0.08
0.10
0.09
0.09
0.08
0.08
0.14
0.11
0.13
0.11
Select Combinations of Flow Rates and Needles Sets for Use with
Hizentra, Cuvitru, and Gammagard Liquid
(Note that the following tables are only for the subcutaneous use of the immunoglobulin listed.)
10 F120 RMS 1-2609 8.2 8.2 10 1:12 Suggested start Peds
10 F180 RMS 1-2609 10.5 10.5 10 0:57 Suggested start Peds
20 F275 RMS 2-2609 17.1 8.5 10 1:10 Suggested start Peds
20 F600 RMS 2-2609 29.6 14.8 10 0:40 Suggested start Peds
40 F600 RMS 3-2609 33.9 11.3 13.3 1:10 Suggested start Adult
40 F900 RMS 3-2609 44.3 14.8 13.3 0:54 Suggested start Adult
60 F900 RMS 4-2609 49 12.3 15 1:13 Suggested start Adult
50 F2400 RMS 3-2609 72.2 24.1 16.67 0:41
6
th
Infusion of biologic and beyond
100 F2400 RMS 4-2609 85.5 21.4 25 1:10 6
th
Infusion of biologic and beyond
(NEEDS TWO SYRINGES)
20 F600 RMS 2-2609 22.5 11.2 10 0:53 Suggested start Peds
30 F900 RMS 2-2609 28.3 14.2 15 1:03 Suggested start Adult
30 F2400 RMS 2-2609 41.9 20.9 15 0:42 6
th
Infusion of biologic and beyond
Hizentra – with FREEDOM60® or FreedomEdge® with 20ml syringe
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.

English 16 of 20
(Note that the following tables are only for the subcutaneous use of the immunoglobulin listed.)
**Indicates 24 gauge needle was used.
10 F275 RMS 1-2609 12.1 12.1 10 0:49
1
st
Two Infusions patients under 40kg
20 F275 RMS 1-2609 12.1 12.1 20 1:39
1st Two Infusions patients under 40kg
20 F600 RMS 2-2609 25.7 12.8 10 0:47 1st Two Infusions patients under 40kg
50 F600 RMS 2-2609 25.7 12.8 25 1:57
1
st
Two Infusions patients over 40kg
60 F1200 RMS 2-2609 37.1 18.6 30 1:37 Subsequent Infusions
60 F2400 RMS 2-2409** 110.5 55.4 30 0:32 Subsequent Infusions
60 F1200 RMS 1-2409** 55.3 55.3 60 1:05 Subsequent Infusions
100 F2400 RMS 4-2409** 132.8 33.2 25 0:45 Subsequent Infusions
20 F500 RMS 1-2609 12.9 12.9 20 1:32 1ST Two Infusions patients under 40kg
30 F900 RMS 2-2609 24.6 12.3 15 1:13
1st Two Infusions patients over 40kg
30 F2400 RMS 1-2609 21.2 21.2 30 1:24 Maintenance Infusions
30 F1200 RMS 1-2409** 42.1 42.1 30 0:42 Maintenance Infusions
Cuvitru – with FreedomEdge® with 30ml ml syringe
Cuvitru – with FREEDOM60® or FreedomEdge® with 20ml syringe
Drug volume
(ml) Flow Tube High Flo Set* Flow Rate
Total (ml/hr)
Flow rate/site
(ml/hr)
Vol/site
(ml) Time NOTES:
20 F45 RMS 1-2609 14.2 14.2 20 1:24 Patients under 40kg (Initial)
60 F120 RMS 2-2609 39.8 19.9 30 1:30 Patients over 40kg (Initial)
100 F420 RMS 4-2609 119.1 29.8 25 0:50 Patients over 40kg (maintenance infusions)
20 F120 RMS 2-2609 30 15 10 0:40 Patients under 40kg(Initial)
30 F180 RMS 2-2609 39.8 19.9 15 0:45 Patients over 40kg (Initial)
30 F120 RMS 1-2609 27 27 30 1:06 Patients over 40kg (Maintenance)
Gammagard Liquid – with FreedomEdge® with 30ml syringe
Gammagard Liquid – with FREEDOM60® or FreedomEdge® with 20ml 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: HIgH-Flo needle sets: First number references the number of needles, the next two
numbers reference the needle gauge, and the last two numbers reference the needle length
in millimeters

Warranty Information:
Limited Warranty: RMS Medical Products/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
FREEDOM60® 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 FREEDOM60® using RMS accessories to ensure that the
FREEDOM60® operates in accordance with published specification standards. If
non-RMS accessories are used in conjunction with the FREEDOM60®, RMS does not
represent that the FREEDOM60® will operate in accordance with published
specification standards. The FREEDOM60® warranty does not cover third-party
products or accessories.
English 17 of 20

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, 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 sucient 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 aect its stability or reliability, or which has
been subjected to misuse, negligence or accident.
• Limitations and Exclusions: Repair or replacement of a syringe driver or
component part is the EXCLUSIVE remedy oered 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 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.
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.
English 18 of 20

English 19 of 20
Denition of symbols:
Manufacturer
Quantity
Caution
On
Catalog number
Consult instructions for use
Do not reuse
Authorized representative in the
European Community
Serial number
Use by YYYY-MM-DD or YYYY-MM
Sterilized using irradiation
Batch code
European Conformity
Do Not Use if Package
is Damaged
Prescription Only
O

337125 Rev N
0086
RMS Medical Products
24 Carpenter Road
Chester, NY 10918 USA
Ph. 800-624-9600 • 845-469-2042
www.rmsmedicalproducts.com
The FREEDOM60® and FreedomEdge® Syringe Infusion Systems, RMS Precision Flow Rate Tubing™, HIgH-Flo
Subcutaneous Safety Needle Sets™ and DynEQ™ are registered trademarks of RMS Medical Products and
are compliant with Medical Device Directive 93/42/EEC. RMS Medical Products is ISO 13485 certied.
© 2017 RMS Medical Products; All Rights Reserved.