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Your home care provider is: Drug Dose (ml’s) Precision tubing set HIgH-Flo needle set RMS resources (web links are case sensitive): Interactive Patient Information Guide joom.ag/VbXb Top 10 FAQs bit.ly/topFAQs Connections Blog Featuring Joanna Tierno blog.rmsmedicalproducts.com Like us on facebook bit.ly/freedom60 6-minute Administration Training Video bit.ly/adminvid1 RMS Medical Products has not performed any clinical testing to support the claims contained in this brochure. Claims have been taken from wide variety of reference materials including, but not limited to the following references: • CSL Behring: Hizentra Package Insert • Berger, M., Duff, K., Poll, J., Roy, S., “IgG Replacement by the Subcutaneous Route Using Preparations Licensed in the USA for Administration by Other Routes”, 5th International Symposium on IVIG; 25-27, September 2003: Interlaken, Switzerland. • Michael F Haller, “Converting Intravenous Dosing to Subcutaneous Dosing with Recombinant Human Hyaluronidase” MagCloud October 2, 2007. 1-11 • Gregory I Frost, “Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration.” Informa UK lit ISSN 1742-5247 • Viral Kamsara; Amitava Mitra; Yunhui Wu, “Subcutaneous Delivery” Drug Delivery Technology June 2009 Vol 9 No 5 pp 38:43 • Jorgensen, J.; Romsing, J.; Rasmussen, M.; Moller-Sonnergaard, J.; Vang, L.; Musaeus, L. “Pain Assessment of Subcutaneous Injections” The Annals of Pharmacotherapy 1996 July August, Vol 30 729-732 The information and suggestions contained herein are supplemental and limited, and as such are provided only for your convenience to assist you in the use of the FREEDOM60® with IgG. Always consult your physician and/or your home care provider for any medical advice, current approved protocols and refer to the package insert that comes with your drug. This brochure should not be used to make any medical decisions or to supercede instructions from your medical professionals. 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 certified. © 2016 RMS Medical Products; All Rights Reserved. European Representative: RMS Medical Products UK, Ltd. 146 Allerton Road • Mossley Hill, Liverpool L18 2DH, UK 845•469•2042 800•624•9600 rmsmedicalproducts.com F60_BR_PatientInfoGuide_03-1098vH Patient Information Guide
12

Drug Precision tubing set HIgH-Flo needle set...Recombinant Human Hyaluronidase” MagCloud October 2, 2007. 1-11 • Gregory I Frost, “Recombinant human hyaluronidase (rHuPH20):

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Page 1: Drug Precision tubing set HIgH-Flo needle set...Recombinant Human Hyaluronidase” MagCloud October 2, 2007. 1-11 • Gregory I Frost, “Recombinant human hyaluronidase (rHuPH20):

Your home care provider is:

Drug

Dose (ml’s)

Precision tubing set

HIgH-Flo needle set

RMS resources (web links are case sensitive):

Interactive Patient Information Guidejoom.ag/VbXb

Top 10 FAQsbit.ly/topFAQs

Connections Blog Featuring Joanna Tiernoblog.rmsmedicalproducts.com

Like us on facebookbit.ly/freedom60

6-minute Administration Training Videobit.ly/adminvid1

RMS Medical Products has not performed any clinical testing to support the claims contained in this brochure. Claims have been taken from wide variety of reference materials including, but not limited to the following references:

• CSL Behring: Hizentra Package Insert• Berger, M., Du�, K., Poll, J., Roy, S., “IgG Replacement by the Subcutaneous Route Using Preparations Licensed in the USA for Administration by Other Routes”, 5th International Symposium on IVIG; 25-27, September 2003: Interlaken, Switzerland.• Michael F Haller, “Converting Intravenous Dosing to Subcutaneous Dosing with Recombinant Human Hyaluronidase” MagCloud October 2, 2007. 1-11• Gregory I Frost, “Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and �uid administration.” Informa UK lit ISSN 1742-5247• Viral Kamsara; Amitava Mitra; Yunhui Wu, “Subcutaneous Delivery” Drug Delivery Technology June 2009 Vol 9 No 5 pp 38:43• Jorgensen, J.; Romsing, J.; Rasmussen, M.; Moller-Sonnergaard, J.; Vang, L.; Musaeus, L. “Pain Assessment of Subcutaneous Injections” The Annals of Pharmacotherapy 1996 July August, Vol 30 729-732

The information and suggestions contained herein are supplemental and limited, and as such are provided only for your convenience to assist you in the use of the FREEDOM60® with IgG. Always consult your physician and/or your home care provider for any medical advice, current approved protocols and refer to the package insert that comes with your drug. This brochure should not be used to make any medical decisions or to supercede instructions from your medical professionals.

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 MedicalProducts and are compliant with Medical Device Directive 93/42/EEC. RMS Medical Products is ISO13485 certi�ed. © 2016 RMS Medical Products; All Rights Reserved.

European Representative: RMS Medical Products UK, Ltd.146 Allerton Road • Mossley Hill, Liverpool L18 2DH, UK

845•469•2042800•624•9600rmsmedicalproducts.com

F60_BR_PatientInfoGuide_03-1098vH Patient Information Guide

Page 2: Drug Precision tubing set HIgH-Flo needle set...Recombinant Human Hyaluronidase” MagCloud October 2, 2007. 1-11 • Gregory I Frost, “Recombinant human hyaluronidase (rHuPH20):

A subcutaneous (sub-q) infusiondelivers medication through a thinneedle to the fatty tissue just underthe skin. See page 11 for commonplaces to infuse.

Compared to IV, sub-q means smaller needles and more personal choice over when to infuse. It eliminates the need for vein punctures. Studies show sub-q may reduce adverse reactions such as severe headache, nausea and vomiting. Many healthcare providers and patients prefer sub-q immunoglobulin (SCIg) over intravenous delivery (IVIg).

Subcutaneous slows down the rate that medication enters the bloodstream. Combined with more frequent delivery, this provides more consistent and stable blood levels, decreases side e�ects and improves overall quality of life.

18

12

60 14 28

SCIgIVIg

Days

Ig L

evel

s (g

/L)

Sub-q?Why

table ofcontents

For the interactive versionof this Patient Information Guide,

please visit: joom.ag/VbXb

The System

The Pump

Minimizing Site Reactions& Dynamic Equilibrium

The Tubing

The Needles

Step-by-Step Instructions

Troubleshooting

Patient Q&A

4-6

6, 7

8

9

10, 11

12-14

15, 16

17-23

SCIg vs. IVIgCan be administered dailyto monthly, as determinedby your provider

Administered once every3-4 weeks

No venous access required Venous access required

Can be self-infused at homeafter brief training

Usually administered bytrained healthcare personnel

Can be done anywhere atpatient’s convenience

Usually administered athealthcare o�ce/hospital

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4 5

- Nancy H.SCIg Patient

No complications, no batteries, no settings.I just wind up, push the button, and I'm

good to go! Please don't ever stopmaking this wonderful little machine!

The Freedom infusion family:For smaller volume infusions, RMS’ FreedomEdge™ has all the performanceand technology of the FREEDOM60®in a simpler design for 20mland 30ml syringes.

the system

- Dave K.SCIg Patient & Specialty

Pharmacy Sales Rep.

HIgH-Flo needles have been agame changer for my therapy.

I'm no longer searching for abetter needle set because I've

discovered the best! Thanks RMS!

The freedom toinfuse anywhere.

Delivering dependableand responsiveinfusions.

Designed for the sub-qpatient's needs.

connectionsmatter

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Helps prevent contamination.Pump will only work if a tubingset with this disc is present.

Only 2 controls &no batteries orelectricity needed.

Pushes endof syringeuntil themedicationin syringeis �nished.

WIND-UP KNOBMALE LUERON/OFF SWITCH

HANDLE

60ml SYRINGELUERDISC

PUMP NOSE

SYRINGESHIELD

BLACK TAB

END OFTRACK

NEEDLE

FEMALE LUER

BUTTERFLYSafety closure − makes for easy &safe insertion & removal of needles.

26 gauge with backcuttip for maximum �ow &smooth insertion.

EMERGENCYSLIDE CLAMPwith �ow rate number

EMERGENCYSLIDE CLAMP

Stops �owimmediately,

if needed.

the system

6 7

The FREEDOM60® is a completely portable syringeinfusion system that gives you the freedom to infuseanywhere, without the need for electricity or batteries. Itoperates at a constant, safe pressure, using RMS PrecisionFlow Rate Tubing™ to control the �ow rate and infusion time.It can be used for almost any subcutaneous or intravenousadministration with a 60ml syringe.

the pump

Know your number!Your RMS Precision Flow Rate Tubing™ controls your in-fusion. Remember which tubing number you use (e.g. F420),and check the F-number on each tag to make sure you havethe correct set. For a list of Precision tubing available fromRMS, see page 9.

Inside the FREEDOM60®The FREEDOM60® uses advancedtechnology to maximize thepatient experience. Learn moreat: www.freedom60.com

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9

Site ReactionsMinimizing

8

Change your infusion timewith PrecisionRMS Precision Flow Rate Tubing™ controls your �ow rate and infusion time. It does this by creating a �ow restriction, using some of the most accurate microbore tubing in the world. RMS makes quality our �rst priority, for predictable and consistent infusions.

Each F-number provides a di�erent level of �ow restriction, which, when combined with the viscosity of the medication, provides a precise delivery. The unique �ow restriction of Precision combines with the constant safe pressure of the FREEDOM60® to respond in real time to a patient’s infusion sites with Dynamic Equilibrium.

We o�er more than twenty di�erent varieties of Precisiontubing, so that you can get the infusion rate you need. If youhave been thinking about a change, ask your provider* to help determine which tubing is best for you.

*This may be your immunologist, your specialty pharmacist, or another healthcare provider involved with your infusion supplies.For your safety, don’t forget your Precision!If you accidentally connect your HIgH·Flo safety needle set directly to the syringe without a Precision �ow rate tubing set attached, the FREEDOM60® will eject the syringe.

the tubingCan you minimize site reactions through your choice of supplies? Many patients say yes!Things to keep in mind:• Longer needles often help reduce site reactions;• Go for more sites and less drug per site if you are still having problems;• Inserting dry needles will minimize skin irritation;• Watch out for dressing and tape sensitivities;• Starting with a slower �ow rate helps reduce initial local reactions (see tubing chart).

connect tubing luer to syringe connect tubing end to needles1 2

For more details, see Troubleshooting on page 15.

Note: Site reactions in new patients usually diminishover time as the sub-q depots become more developed.

Other pumps, designed for constant �ow (such as electronicpumps), respond to tissue saturation by increasing pumpingpressure to maintain their programmed �ow rate. High pumppressures can cause high pressures within infusion sites, leadingto more problems at each site (shown below).

Sub-q Flow Rate Tubing Item Numbers:

s l o w� o w

moderate�ow

rapid�ow

F275 F420 F500 F600 F900 F1200 F2400

Most Common Sub-q Flow Rates

What does DynEQ™ mean for you?

A Balanced InfusionThrough DynEQ™

DynEQ™ (Dynamic equilibrium) balances your fastestinfusion with your most comfortable one. You get to infuse asrapidly as your provider recommends. If the pressure in yoursite(s) increases, the system immediately responds by auto-matically slowing down. The pump will maintain a safepressure of 13.5 psi throughout the infusion (see below).

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the needles

1110

Avoid lumps & bumps

Your healthcare provider can help �nd the best sites for your needle insertion. The abdomen is the most common place, but ask your provider aboutyour options.

Some medications require that sites be 2+ inches apart, and that needles are inserted at a 90° angle. Check your package insert.

If and how to rotate infusion sitesshould be a subject for discussion with your healthcare provider. You may achieve better results by periodically returning to sites that have workedwell in the past. However, some people �nd di�culty with repeated use of thesame sites.

Sub-q Injection Sites

Dependable �ow,through every needle,helps your infusionsites all �ll at the samerate − reducing pain,swelling and oozing.

Get equalized �ow tomultiple sites with HIgH·Flo

customluer design

BACKOF ARMS

ABDOMEN

THIGHS

SIDE OFUPPER HIP

90°

What goes into a great needledesigned speci�cally for your sub-q?Combined with FREEDOM60®, HIgH·Flo maximizes Dynamic Equilibrium for a fast, comfortable, and predictable infusion.

Custom luer consistently provideseven �ow to every infusion site.

Y-Connector combinessets for more than 6 sites(up to 8), or to enable infusingwith two di�erent needle lengths.

20” tubing for fewertangles and lowerresidual volume.

Sets available in single,double, triple, quad, pentaand hexa con�gurations.

Safety closurereduces riskof needlestick injuries.

Flexible “�ying hinge”bends to �t your bodyfor less irritation,greatest site comfort,and no indentationsin your skin.

3M Tegaderm™dressing is includedwith all sets.

Needle shieldprotects tipfrom damage.

Needle tip has a backcut design,which makes a tricuspid incision(shown above), resulting in lesstearing of the skin.

actual 26gneedle sizes

26 gauge needlefor maximum �owperformance with4, 6, 9, 12 & 14 mmlengths available.

HIgH·Flo needleincision

other brandincision

Emergencyslide clamp.

-Maureen H. SCIg Patient

-Ted S. SCIg Patient

Each HIgH·Flo needle is sharp and goes in sosmoothly. I also notice little or no irritation toeach of my infusion sites.

As compared to the previous needles I wasusing, I experience signi�cantly less discomfortwhen inserting the HIgH·Flo needle. In fact, Ibarely feel it at entry.

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1312

Step 3 - �ll syringe

Step 2 - wash hands

Step 4 - verify tubing and needles

Step 1 - prepare area and lay out supplies

Step 6 - attach tubing to needle set

Sub-qStep-by-Step Instructions

Clean your work areawith alcohol or disin-fectant soap and water.Verify that you have thecorrect supplies recom-mended by your health-care provider and laythem on clean surface.

Be sure the product is at roomtemperature before you begin�lling the 60ml syringe withyour required dose. Refer tothe manufacturer's instructions,or ask your provider for moredetailed �lling instructions.

Wash your hands thoroughly and, if required, put ondisposable gloves.

Again, verify thatyou are using thecorrect tubing andneedles recom-mended by yourhealthcare providerand prescribed byyour doctor.

Step 5 - attach tubing to syringe

Remove the sterile capfrom the luer disc end ofthe RMS Precision Flow RateTubing™ set and connectthe tubing to the syringe.

Step 7 - ensure black tab is at end of trackMake sure the pump is o�and the black tab inside theclear view syringe shield is atthe end of its track. If the blacktab is not at the end of its track,wind the large knob clockwise.

Step 8 - load prepared syringe into pumpWith syringe gradations facingup, load the syringe and itstubing into the pump. Makesure the luer disc end of the�ow rate tubing is fully seatedin the pump’s nose.

Step 9 - priming needle set

Be sure to use the complete protocol supplied by your healthcare provider.

Remove the sterile caps fromthe ends of the HIgH·Flo needleset and Precision tubing set.Connect the sets together,using care not to contaminatethe ends.

Turn the pump on to prime (�ll) the tubing, but try to stop the�ow about two inches short of the needles. To minimize siteirritation, it is recommended to insert the needles dry. To stop�ow to the needles, turn the pump o� and wind the large knobclockwise until the black tab is clearly not touching the syringe.

bit.ly/adminvid1for sub-q admin.

training video

visit:

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1514

Step 11 - check for blood return

Insert the syringe back into the pump and turn the pumpON to begin the infusion.

Step 13 - upon completing infusion

Step 12 - begin infusion

Step 10 - inserting needle

Once the infusion is complete, turnthe pump OFF. One at a time, holdeach needle in place and peel backany adhesive or dressing aroundit. Remove the needle in a straightmotion, opposite the direction youinserted it. Wind the large knobuntil the black tab is at the endof its track. Remove the syringe. Cleanse each site and cover with a bandage. Discard all sharps and biologics as required.

Troubleshooting

Swelling, pain or redness at the siteNeedles may play a signi�cant role in adverse site reactions with sub-q according to continuing research. Among the many factors which may contribute to infusion site reactions are: the quality of the needles being used; design of needle tip; needle tip damage; sharpness; needle length; number of sites; �ow rate; and, dressing/covering.

1) Verify you are using RMS HIgH·Flo needles. If not, consult your healthcare provider and inquire abouttrying HIgH·Flo.2) Be sure to insert your subcutaneous needles dry. IgG tends to irritate the skin. 3) Assure that the needles you are using are long enough to reach your sub-q layers. 4) Ask your provider about trying a slower rate tubing set, especially for your �rst few infusions. 5) Think about site location. If you have been having di�culty with rotating sites, you may want to return to the sites that work best for you. Talk with your provider about your options.

No �ow1) Assure that the pump is in the ON position. 2) Make sure all slide clamps are unclamped. Note: if a slide clamp has been overused, or left clamped for an extended time, it can damage the tubing.3) Use sterile procedures to disconnect the tubing set from the needle set and check for medication drip. If medication drips from the tubing, it may be a problem with the needle set. If the medication does not drip, replace the tubing as it may be damaged.

Slow �ow1) Administration may be slow, based on how well medica-tion is absorbed through your tissue. If this is your �rst time with sub-q, it may take longer than expected because your body may need to create space in the subcutaneous layers in order to infuse in the time desired.2) It is best to avoid placing needles near areas of scar tissue, or on top of muscle.

For complete instructions, please refer to the InstructionsFor Use included with your pump.

Remove the syringe from the pump. With the syringe out of thepump, check for blood return by gently pulling back on theplunger. Watch to make sure no red or pink appears in thetubing near your sites. If blood return does exist, clamp the�ow to that site and call your healthcare provider to determineif the dose can be run using the remaining sites. If so, continue.If not, remove all needles, attach a new needle set and startagain from step 8.

Select your sites, cleanse with alcohol and let dry. Carefully re-move shield from the needle tip, without touching the needle. Pinch the skin and insert each needle into subcutaneous tissue. Secure with adhesive dressing.

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1716

Q&APatientAlways consult your healthcare provider and refer tothe product’s Instructions For Use.

Q. Is my FREEDOM60® working? How can I tell if I am infusing?A. First, verify that your Precision tubing is the right F-number. Then, check that the pump winds properly and makes a distinctive 'whirr' noise when turned on – this means the pump is working properly. Finally, note the time the infusion starts and watch that the syringe plunger moves in accordance with your estimated infusion time. If there is any doubt, please talk to your healthcare provider.

Q. How can I �nd my best infusion sites?A. Simply time your infusions! Note howlong the �rst half of your dose takes,and then the second half. Comparethe two times. If the second halftakes longer, you may be able to�nd sites that accept the drug moreeasily. If the two times are just aboutequal, it usually means your sites are accepting the drug well, and the site pressure is not increasing over the duration of your infusion.

Q. What’s the noise the pump creates when I �rst turn it on?A. That is the black tab looking for thesyringe. The pump is designed to searchfor the syringe, which could be �lledanywhere from 1ml up to 60ml. Oncethe black tab �nds the syringe, it makes a “thunk”sound and is then silent for the rest of the administration.

Q. What if I want to administer a larger or smaller amount of �uid than 60ml?A. If a dose is larger than 60ml, you can load an additional

the pump

For more details about how the FREEDOM60® worksto protect you, see DynEQ™ on page 8.

Note: Your FREEDOM60® is designed to slow down ifit encounters a problem. If the pump is making its dis-tinctive ‘whirr’ and ‘thunk’ at the beginning of your infusion, it is working properly.

Slow Flow (continued)3) It is also possible you may need more sites, longer needles or a faster �ow rate tubing set.4) Slow �ow can also be a symptom of blocked or poor quality needles. If you are not using HIgH·Flo Subcutaneous Safety Needle Sets™, talk to your healthcare provider abouttrying them.

Flow continues for a short time even when the pump is turned o�This is a normal function of the pump. The pump is designed to maintain pressure during and after the infusion to prevent drug back�ow. To stop �ow:1) Turn the switch OFF and wind the knob clockwise so the black tab moves away from the syringe releasing pressure on the plunger; or,2) Use the slide clamp. (We recommend using the slide clamp only in case of an emergency. Overuse can damagethe tubing.)

Syringe will not load or remove from pumpYou will never need to use force to load or remove a syringe. Make sure the pump is in the OFF position and that the black tab is at the end of its track. If the black tab is not at the end of its track, wind the large knob all the way back and try again.

Syringe will not stay inside in the pump1) Make sure you have not attachedthe HIgH·Flo needle set directly tothe syringe.2) Be sure you are using appropriate �ow rate tubing with a luer disc. 3) Make sure that the luer disc at theend of the tubing is properly seatedin the nose of the pump (see imageon page 6).

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18 19

syringe using the same tubing and needle set. For smaller volumes, the FREEDOM60® will adjust to whatever amount is contained in the syringe. We also o�er the FreedomEdge™, which is designed for smaller volumes and accommodates both 20ml and 30ml syringes (see page 4).

Q. What if I want my infusion to go faster?A. See page 9 to learn more about all the RMS Precision Flow Rate Tubing™ choices available. Then talk with your provider to see if a change is appropriate.

Q. What happens if I turn the large wind-up knob during an infusion?A. Nothing. The wind-up knob is disengaged while the pump is ON . There is no e�ect whatsoever by turning the knob in either direction.

Q. Can I over-wind the FREEDOM60®?A. No. When the black tab reaches the track end, the pump is fully wound, and the wind-up knob will start tomake a clicking sound, like the gas cap on acar. If for any reason the pump will not wind,make sure the switch is OFF . If it is o�and still does not wind, the pump may bedamaged. Talk to your provider about a replacement.

Q. How do I clean the FREEDOM60®?A. Soap and water or any non-alcohol surface disinfectant can be used to clean the FREEDOM60®. If it becomes necessary to clean the syringe shield, use a bottle brush. Make sure no �uid enters the inside of the pump, it may cause damage. See manual for more information.

Q. Can the FREEDOM60® be used at high altitudes, such as in aircraft?A. Yes. It can be used in any position, at any altitude.

Q. Can the FREEDOM60® be used for applications other than SCIg?A. Yes. The FREEDOM60® can be used to administer most intravenous and subcutaneous medication that will �t in a 60ml syringe.

the tubing

Q. Does the FREEDOM60® need maintenance?A. The robust design of the FREEDOM60® is made to withstand day-to-day home use without any scheduled maintenance. In addition, there are no user serviceable parts inside. You should never attempt to open the pump. If you ever experience a pump problem, immediately advise your healthcare provider who can arrange for a replacementif necessary.

Q. What makes Precision tubing so special? A. RMS Precision Flow Rate Tubing™ is made in the USA at the RMS factory. Our manufacturing expertise, mastered through decades of experience, ensures accurate and dependable infusions with RMS Home Infusion pumps, maximizing the bene�ts of DynEQ™ (Dynamic Equilibrium).

Q. What a�ects the �ow rate of the FREEDOM60®?A. The two main factors are the diameter of the tubing and the viscosity of the �uid. Immunoglobulin, for example, will �ow much slower than an antibiotic. Since temperature also a�ects the viscosity of �uid, when the temperature is cold, the �ow slows down and when the temperature is warm,the �ow rate increases.

Q. Why can’t I connect the needle set directly to the syringe?A. You need a restrictive tubing with a disc luer. This makes sure your infusion is delivered at a controlled rate, and that the syringe stays properly seated in the pump.

Q. What is the temperature range that I caninfuse in?A. For accuracy and safety, most medications must be delivered at room temperature.

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20 21

Q. Why do you call them HIgH·Flo?A. Made for sub-q, 26 gauge HIgH·Flo (high performance �ow) sets o�er faster infusion rates than typical 27 gauge needle sets. Note: If you are transitioning from 27 gauge, your provider might give you a di�erent F-numbered Precision tubing set to keep your infusion time aboutthe same.

Q. How can the smaller 26 gauge HIgH·Flo sets �ow at the same rate as other brand sets using larger 24 gauge needles?A. HIgH·Flo needle sets are carefully designed to optimize �uid �ow for the most e�cient handling of drugs. This e�ciency translates into higher �ow rates from smaller diameter needles.

Q. Are there 24 gauge HIgH·Flo sets available?A. Yes, HIgH·Flo is also available in 24 gauge, for when extremely high �ow rates are required. Most FREEDOM60® patients do not need 24 gauge needles.

Q. What is the least painful way to insert RMS HIgH·Flo Subcutaneous Safety Needles™? A. Many patients tell us that they grab the wings above the needle, tightly pinch the skin at the site close together between their �ngers, and insert the needle straight into the pinched area with a dart-like motion. You may notice that the HIgH·Flo butter�y wings are very �exible, making this procedure easy. Each site should be about 2” apart and needles should be inserted at a 90° angle, as mentioned on page 11. Make sure any alcohol

24 gauge 27 gauge HIgH•Flo26 gauge

the needleshas evaporated o� your sites, and insert all needles dry.You can also talk to your provider about premedication.

Q. I heard I should insert the needles dry. Whatis the reason for this?A. Patients have found that insertingneedles wet with drug is irritating to themast cells in the skin, so inserting dryallows the needles to penetrate into thesubcutaneous layer without impacting themast cells. This may result in less pain. If medication ends up on the needle tip, do not touch the needle. Allowthe needle to dry for a few minutes before insertion.

Q. Why is a 3M Tegaderm™ dressing supplied with each needle? A. Consensus from several medical centers and many patients was that genuine 3M Tegaderm™ is preferred bymost patients, so we include it with your needles. We weretold it had the least irritation and best adhesion to the skin. If you are a patient with dry or sensitive skin and �nd that the 3M Tegaderm™ is irritating, you may need to try di�erent dressings, paper tape, or a cloth wrap. Askyour healthcare provider for suggestions.

Q. I have heard HIgH·Flo can improve how my sites �ll. How?A. HIgH·Flo needles are carefully designed and thoroughly tested to ensure equal �ow to every needle. To our know-ledge, no other manufacturer goes through these steps. Varying �ow rate may be due to: the manufacture of other sets, placement of the needle (e.g., in scar tissue, or over muscle), needle length or new site location.

Q. Can HIgH·Flo be used with 20% solutions of IgG as well as 10% immunoglobulin?A. Yes. HIgH·Flo needles are FDA-cleared for all sub-q medications. The 10% solutions will �ow faster than 20%. Flow can be adjusted by the choosing a di�erent RMS Precision tubing. If your sites are capable, the needles will be able to deliver the highest �ow rate as stated in the drug’s package insert.

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22 23

9mm 12mm

OPTI

MAL

NEE

DLE D

EPTH

Q. How do I know if I am using thecorrect length needle?A. Needle length should be determinedaccording to how much sub-q tissue apatient has. 9mm and 12mm needles tendto work well with average sized patients(as shown in the image to the right); while6mm needles may be needed for verythin adults and children. Similarly, largerpatients may require 14mm needles.

Q. When using more than one needle, do I need to do anything special to be sure the drug is evenly distributed?A. No special actions are necessary.Equal �ow to each site reduces therisk that one site will over-�ll.Dynamic Equilibrium automaticallyslows down the infusion to any siteif pressure increases − to help pre-vent pain swelling, and oozing.Sites that still regularly �ll more thanothers may be an indication that those subcutaneouslayers have more space, or that di�erent locations require di�erent length needles.

Q. Can HIgH·Flo needles be used with other pumps besides the FREEDOM60®?A. Yes. Our needles are compatible with other pumps, including RMS' FreedomEdge™. However, only RMS Home Infusion systems o�er DynEQ™ (Dynamic Equilibrium), which automatically adjusts the �ow rate if the tissues at the infusion site become saturated. To achieve the full bene�ts of DynEQ™ , we recommend that you use HIgH·Flo needle sets with our pumps. Constant �ow pumps use higher pressures and are not sensitive to the back pressure and, therefore, will continue the stated �ow rate beyond what might be comfortable. This may result in painful, red swollen lumps at the site, drug oozing out of the needles and site irritation.

Q. Why do you call HIgH·Flo “safety” needle sets?A. The butter�y wings 'snap shut' at the ends, to cover the

custom luer design(quad set)

press hereto snap shut

needle after use. This feature of RMSHIgH·Flo Subcutaneous Safety NeedleSets™ is designed to help preventaccidental needle-stick injuries.

Q. Can I check for blood return at the same time for all my sites, or do I have to clamp them each o� individually? A. Actually, we recommend you don't clamp your needles at all, except in the case of an emergency or atthe end of your infusion. When checking for blood return, we suggest following step 11 on page 14 of this guide,but always refer to your provider’s protocols.

Q. Is there a best way to remove the needles and dispose of them when I am done withan infusion? A. If you are unsure of how to handle used needles, ask your healthcare provider to demon- strate. HIgH·Flo has built-in safety. Just 'snap shut' by pressing the wings together, at ends, to entrap the needle and then dispose of the set. Needle sets should be disposed of in a standard sharps container.

Q. Where can I get the FREEDOM60®, Precision tubing and HIgH·Flo needles? What if I have more questions?A. Ask your healthcare provider. Feel free to call/emailus for more information at 1-800-624-9600 (toll free), 1-845-469-2042 (local), or [email protected].

Also, feel free to ask about the FreedomEdge™ Syringe Infusion System, for 20ml and 30ml syringe infusions.