EMD Serono cool.click 2 User manual

RX only
Instructions for Use
Exclusively for use with
EMD Serono Products containing Growth Hormone
[somatropin (rDNA origin) for injection]
Totally Needle-Free
cool.click™ 2 Needle-Free
Growth Hormone Delivery Device

FRONT VIEW REAR VIEW
CAP REMOVED
Dose Display
Cap
Rear Housing Release Buttom
Battery Housing
On/O Switch
Front Housing
Nozzle Locks
Nozzle
IN STORAGE BOX
Storage Box
Dose Setting Key

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Table of Contents
Section 1 Getting Started with cool.click™ 2 page 3
Section 2 Setting cool.click™ 2 for mg or ml Use page 3
- Setting the dose range page 5
- Attaching the nozzle and piston page 6
- Fitting the cartridge connector or the vial connector page 7
- Filling your dose page 7
Section 3 Demonstration and Practice page 9
Section 4 Delivering your Dose page 10
Section 5 Maintenance and Care page 12
- How to store cool.click™ 2 page 12
- How to change the nozzle and piston page 13
- How to replace the battery page 13
Section 6 Frequently Asked Questions (FAQs) page 14
Section 7 Resources page 15
Section 8 Quick Guide page 16

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WELCOME TO cool.click™ 2 NEEDLE-FREE DELIVERY DEVICE
Your doctor has decided to treat you with a EMD Serono growth hormone medication that can
be easily administered using cool.click™ 2, a needle-free delivery device.
cool.click™ 2 is a totally needle-free delivery device exclusively intended for the injection of EMD
Serono growth hormone [somatropin (rDNA origin) for injection].
cool.click™ 2 works by ring a jet of the liquid drug directly through the skin to the subcutaneous
region. The jet is created through a powerful spring acting on a piston inside a nozzle, and the
liquid is forced out through a small hole in the nozzle at high speed. Prior to each injection the
spring must be charged by winding the device. The required dose is then drawn up into the
nozzle, and then the device is discharged with the nozzle held against the skin by pushing the
release button.
Before you get started with cool.click™ 2, please complete these easy steps:
• Thoroughlyreadthisinstructionsforusebeforeyoupracticeusingcool.click™2.
• Foldoutthefrontcoverofthisinstructionsforuse.Youwillndaphotographofcool.click™2
with each of its parts clearly labeled.
This instructions for use will show you how to use cool.click™ 2 with a practice cartridge (or vial)
that comes in your Patient Starter Kit. After you are comfortable using the device on a pad, you’ll
learn how to administer your Growth Hormone medication using cool.click™ 2.
If you have any questions after reading this instructions for use, do not hesitate to ask your doctor
or nurse, or call at Connections for Growth
®
toll free at 800-582-7989 or Serocare
SM
toll-free at
800-714-2437 for referral to the EMD Serono Nurse Network.
Remember, it is important that you feel condent with treatment right from the start.
WARNING
• Thepracticecartridge(orvial)liquidisnotforinjectioninhumans.
• Physician ornurse trainingshouldbe providedto youbefore youor yourchild usethis
product.
• Parentsmustexplaintotheirchildrenthatcool.click™2isnotatoy.Adultsupervisionis
recommended when children are using cool.click™ 2.
• cool.click™2mustonlybeusedwithEMDSeronogrowthhormoneandnotanyotherbrand
of human growth hormone or medication.
• Aswithanyinjectiondevice,improperuseofcool.click™2mayresultininjury,including
the transmission of infectious blood-borne diseases. Adhere to strict safety and antiseptic
precautions at all times.
CONTRAINDICATIONS
• Inordertousecool.click™2properly,youmustrstunderstandandfollowthestepsdescribed
in this instructions for use. It is important that you use cool.click™ 2 only as indicated and
that you replace cool.click™ 2’s disposable parts as often as recommended.
• Patientsandchildren(withparentalsupervision)whousecool.click™2bythemselvesmust
be able to see the numbers on the dose display clearly, turn the rear housing easily, and press
the release button.
• cool.click™2shouldnotbeusedwithpatientsandchildrenwhohavelowplateletcounts,
bruise or bleed easily, or are taking anticoagulants (blood thinners), or any other medication/
therapy that may contribute to excess bleeding or bruising. Hemophiliacs should not use this
device.
• cool.click™2isnotrecommendedfor patientswhodonothaveadequatesubcutaneous
tissue or normal hematopoietic function.
• cool.click™2shouldnotbeusedwithpatientsforwhomgrowthhormoneiscontraindicated.
Please read the instructions for use or patient’s information leaet accompanying your
prescribed growth hormone medication.
• Ifaftertryingavarietyofdeliverysitesyouarestillunabletousecool.click™2comfortably,
contact your doctor or nurse.

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CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
Section 1
GETTING STARTED WITH cool.click™ 2
WHAT YOU’LL LEARN
In this section, you’ll learn:
• Thenameofeachcool.click™2part
• Howtosetthedoserangeofcool.click™2
• Howtoattachthenozzleandpistonontocool.click™2
• Howtollcool.click™2withyourdose
• Howtopracticeusingcool.click™2withapracticecartridge(orvial)
WHAT YOU’LL NEED
• cool.click™2device
• nozzleandpiston*
• alcoholwipes*
• sterilegauzepadorcottonball*
• practicecartridge(orvial)*
• click.easy™Demokit*
• practicepad*
*IncludedinyourPatientStarterKit.
BEFORE YOU GET STARTED
It is important to know the names of all cool.click™ 2 parts. To learn each of the names, unfold
the front cover of this instructions for use. You’ll nd a photograph of cool.click™ 2 with each
part clearly labeled. Keep this page open as you learn how to use cool.click™ 2.
IMPORTANT
Always wash your hands thoroughly with antibacterial soap and water before using cool.click™ 2.
Make sure to use a clean towel when drying your hands. Then place all of your cool.click™ 2
materials on a clean, dry surface.
Section 2
SETTING cool.click™ 2 FOR mg OR ml USE
cool.click™ 2 has an LCD display for indicating the dosage. This can be set to read either milligram
(mg) of growth hormone, Table 1, or milliliter (ml) of liquid dose, Table 2, which is specic to the
EMD Serono growth hormone medication that your doctor has prescribed for you.
cool.click™ 2 can be set to one of six dierent dose ranges, indicated by the letters A to F at the
top of the display. You doctor will tell you what setting you will need for cool.click™ 2.
Please ask your doctor or healthcare provider about setting the device.
CAUTION
• On delivery, cool.click™ 2 will be in a “null” mode, and when it is rst switched on the
display will show as in the gure below. No dose can be displayed until the dosage range
has been set.

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• YoumustsetthedoserangeapplicablefortheEMDSeronogrowthhormonemedication
that your doctor has prescribed you. Please look carefully at Table 1 and Table 2 hereafter
that list the various growth hormone medications. Search for your prescribed medication
and note the corresponding setting (e.g. B, D, ml…).
• Then,tosettheappropriatedoserange,followtheinstructionsprovidedinthesection
entitled Setting the dose range.
• Yourphysicianornursewillsetthedeviceforyou,donotsetthedevicewithoutguidance
from a nurse or physician trainer.
Table 1 – Dosing in milligrams (mg)
GROWTH HORMONE PRODUCTS FOR USE WITH cool.click™ 2
IMPORTANT: APPROPRIATE cool.click™ 2 SETTING SHOULD BE DONE UNDER THE DIRECTION OF A HEALTHCARE PROFESSIONAL ONLY
cool.click™ 2 Setting Required Product Fixed Volume of Diluent (ml) Fixed Concentration (mg/ml) Milligram Dose Increments Doses Feasible per Injection
BSaizen®8.8 mg click.easy™ 1.51 ml 5.83 mg/ml 0.02 mg 0.30 – 2.92 mg
DSaizen®8.8 mg in vial 2.00 ml 4.40 mg/ml 0.02 mg 0.22 – 2.20 mg
Table 2 – Dosing in milliliters (ml)
GROWTH HORMONE PRODUCTS FOR USE WITH cool.click™ 2
IMPORTANT: APPROPRIATE cool.click™ 2 SETTING SHOULD BE DONE UNDER THE DIRECTION OF A HEALTHCARE PROFESSIONAL ONLY
cool.click™ 2 Setting Required Product Flexible Volume of Diluent (ml) Concentration Range (mg/ml) Milliliter Dose Increments Doses Feasible per Injection
ml Saizen®5 mg in vial 1.0 – 3.0 1.67 – 5.00 mg/ml 0.01 ml 0.08 – 2.50 mg
ml Saizen®8.8 mg in vial 2.0 – 3.0 2.93 – 4.40 mg/ml 0.01 ml 0.15 – 2.20 mg
ml Serostim®4 mg in vial 0.5 – 1.0 4.00 – 8.00 mg/ml 0.01 ml 0.20 – 4.00 mg
ml Serostim®5 mg in vial 0.5 – 1.0 5.00 – 10.00 mg/ml 0.01 ml 0.25 – 5.00 mg
ml Serostim®6 mg in vial 0.5 – 1.0 6.00 – 12.00 mg/ml 0.01 ml 0.30 – 6.00 mg

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Setting the dose range
1. With the cap in place, hold the cap and front housing in one hand and the rear housing in
the other hand. Rotate the rear housing so that the rear housing moves toward the front
housing as far as it will go. You may notice a slight click as the device engages.
2. Remove the cap and switch on the dose reading by pressing the yellow ON/OFF switch.
3. Take the special dose setting key (you will nd it inside the front cover of this instructions for
use) and insert into the front housing as shown, until it stops with both prongs fully pushed
and then withdraw the key immediately.
4. The display will start to ash, indicating that dose setting mode is active.
5. Press the yellow ON/OFF switch. The display will indicate 0.00 with “ml” ashing. Press the
ON/OFF switch again and the display will show “mg” plus “A” ashing. Repeat this until the
required setting is shown. On each press of the ON/OFF switch the display will step through
the following sequence and repeat:
SEL àml àA m g àB mg àC mg àD mg àE mg àF mg à(repeat)
FPlease note: if you press and hold the yellow ON/OFF switch too long the display will turn
o.
6. Once the required setting is shown, push the key in again and then withdraw the key. The
display will briey blank and then stops ashing. This conrms the setting, and the device
returns to normal operation mode. The setting will now be displayed and will remain
programmed into the device until it is changed in this way again, even if the battery is
removed.
WARNING
• Beforestartingtoinjectyourgrowthhormonemedicationensurethattheappropriatedose
range is set properly. Injecting with cool.click™ 2 set to a wrong dose range will deliver wrong
doses of the growth hormone medication.
• Ifyouarenotsureofsettingtherightdoserangeaskyourdoctorornurse.
• Donotattempttomodifyorresetthedoserangeatanytime,unlessrequiredbyyourdoctor
or nurse.
• Eachtimeyouwilldeliveryourgrowthhormonemedicationwithcool.click™2checkthat
the right dose range letter is displayed.

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CAUTION
• Oncethesettingofthedoserangeiscorrectlydonepleasekeepthedosesettingkeyina
safe place. You will not need it anymore, unless your doctor prescribes for you a dierent
EMD Serono growth hormone medication. Key will be needed for changing the battery.
• Paycarefulattentiontowhennozzleandpistonmustbereplacedanddiscarded.Seesection
5, “Maintenance and Care”, for information on how to change the nozzle and piston.
Attaching the nozzle and piston
FPlease refer to the Instruction for Use accompanying your nozzle and piston pack before
starting using nozzle and piston.
1. First peel open the blister pack containing the nozzle and piston assembly. Remove the
assembly.
2. With the cap in place, hold the cap and front housing in one hand and the rear housing in
the other hand. Rotate the rear housing so that the rear housing moves toward the front
housing as far as it will go. You may notice a slight click as the device engages (see gure in
the section
“Setting the Dose Range”).
3. Remove the cap, and pull back the nozzle locks against the spring as shown.
4. Holding the nozzle locks back, introduce the nozzle and piston assembly to the opening in
the cool.click™ 2 as shown.
5. Push the nozzle rmly so that the piston clicks into place in the cool.click™ 2.
6. Release the nozzle locks, and ensure that they move forward fully. You will notice a “click”.
IMPORTANT
If it doesn’t click, gently push the nozzle into the device until the nozzle locks spring forwards.
7. Check that the nozzle is correctly tted by pulling it and making sure that it stays in the
device. Once locked into position, it is important that a nozzle is installed only once, to avoid
breakage.
CAUTION
• ThoroughlyreadtheInstructionforUseaccompanyingyournozzleandpistonpackfora
proper use of nozzle and piston with your cool.click™ 2 device.
• Thenozzleandpistonaresuppliedasapre-assembledaccessoryinasterileblisterpack.
Check that the expiry date (indicated by the sandglass symbol ) has not expired. Do not use
the nozzle and piston assembly if the blister pack is open or appears damaged.
• Thenozzleandpistonarettedtothecool.click™2together.

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• Ensurethatthenozzlelockshavemovedfullyforwardsafterhavingattachedthenozzle
and piston to cool.click™ 2.
• Donottouchtheendsofthenozzleorallowthemtotouchanysurface.Holdthenozzleby
its sides.
• Donotsharenozzleandpistonbetweenindividuals.
• Disposeofusednozzleandpistonwithcare.Donotreuseorre-sterilizenozzleandpiston
after removal from cool.click™ 2.
Fitting the cartridge connector or the vial connector
Depending on the EMD Serono growth hormone medication that is prescribed for you the
reconstituted solution of the medication will be either in a cartridge or in a vial. For full information
on how to reconstitute and prepare your growth hormone medication please read thoroughly
the Instruction for Use that will come within the pack containing your cool.click™ 2 accessories,
either your cartridge connector pack or your reconstitution kit pack.
In order to draw the reconstituted solution of growth hormone from a cartridge or from a vial
you have to use a connector, which is supplied as an accessory in a sterile blister pack. Do not
use the connector if the blister pack is open or appears damaged.
1. Prior to using either cartridge connector or vial connector check that the expiry date (indicated
by the sandglass symbol ) has not expired.
2. Then t either cartridge connector or vial connector to the cartridge or vial containing
the reconstituted solution of your growth hormone medication as described in the
aforementioned Instruction for Use.
Once this is done you are ready to ll cool.click™ 2 with your dose.
CAUTION
Thoroughly read the Instruction for Use accompanying your cartridge connector pack or your
reconstitution kit pack for a proper use of either cartridge connector or vial connector with
your cool.click™ 2 device.
Filling your dose
1. With the cap in place, hold the cap and front housing in one hand and the rear housing in
the other hand. Rotate the rear housing so that the rear housing moves toward the front
housing as far as it will go. You may notice a slight click as the device engages.
2. Remove the cap and press the yellow ON/OFF switch. The display will switch on and show
0.00, the dose unit “mg” (or “ml”) and the dose range setting (A to F) as appropriate.
or
FPlease note: if the display shows 8.8.8 ashing as in the picture hereafter, further tighten
the rear housing.

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3. Remove the protective cap from the cartridge connector (as shown) or vial connector.
4. Connect the nozzle to the cartridge connector (as shown) or vial connector.
5. Hold the cool.click™ 2 vertically with the cartridge or vial uppermost and the display facing
you. Rotate the rear housing such that the piston will begin to draw the solution of your
growth hormone medication into the nozzle. The display will indicate the dosage drawn. For
example the gure hereafter indicates 2.92 mg in dose range “B”.
6. Once the required dose is indicated on the display, wind one full turn further past the required
dose setting. If there are any air bubbles present in the nozzle, tap it gently with your ngers
to release the air bubbles. Then wind back until the required dose is indicated on the display.
If there is still air bubbles present, wind one full rotation again, tap gently and wind back to
the required dose. Repeat until all air bubbles are gone.
7. Remove the nozzle from the cartridge connector (as shown) or vial connector and re-t the
protective cap onto cartridge or vial .
The cool.click™ 2 is now ready to deliver the injection.
IMPORTANT
• Ifyouoverllcool.click™2pastyourspecicdose,simplywindbackuntiltherequireddose
is indicated on the display.
CAUTION
• Alwayslookattheliquidinsidethenozzle.Thespacebetweenthepistontipandtheendof
the nozzle should be lled with liquid and not air bubbles. If you see air bubbles in the nozzle,
remove them by repeating the operation described above in the
“Filling your dose” section.

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• Neverdischargethedevicewithoutanozzleinplace.
• Neverdischargethedeviceifthenozzleisempty.
• Neverdischargethedeviceiftheliquidinthenozzlehasairinit.
• Donotattempttodismantlethedevice.
Section 3
DEMONSTRATION AND PRACTICE
To practice with cool.click™ 2 use the practice cartridge from the click.easy™ Demokit that you’ll
nd in your Patient Starter Kit.
1. Peel open the blister pack containing a cartridge connector that you will nd in your Patient
Starter Kit.
2. Fit the cartridge connector to the practice cartridge . Please refer to the Instruction for Use
accompanying the cartridge connector pack to do the operation properly.
3. Then ll the nozzle with a dose of practice solution by following the instructions in the
section
“Filling your dose”.
USING THE PRACTICE PAD
The rst time you practice with cool.click™ 2, use the practice pad that came in your Patient
Starter Kit.
1. Supporting the practice pad with one hand, hold the handgrip on the rear housing of cool.
click™ 2.
2. Place the nozzle against the pad and push the rear housing towards the pad just hard enough
to create a slight dimple. Make sure the entire surface of the nozzle is in contact with the
pad, and hold cool.click™ 2 still—rmly, but not hard. You will feel the rear housing slide
forwards slightly. Note that the rear housing must be in this position before the delivery can
be made.
Note: without downward or forward pressure the device will not re. This is a safety feature.
It will prevent the device from ring if injection button is accidentally hit or bumped.
3. Maintain this pressure on the pad and hold cool.click™ 2 still. Then press the release button.
This will deliver the dose. Delivery takes less than a second. Hold the nozzle against the pad,
maintaining the pressure, for approximately 3 seconds before removing.
WARNING
• DONOTINJECTTHEPRACTICELIQUIDINTOHUMANS.
CAUTION
• Remember,neverpressthereleasebuttonunlessliquidisvisibleinthenozzle.
IMPORTANT
• Usethepracticepadtopracticedeliveryofthedoseusingthepracticeliquidasmanytimes
as necessary in order to feel comfortable using cool.click™ 2.
• Onceyoufeelcomfortableusingcool.click™2practicingwithpracticesolution,youareready
to administer your prescribed EMD Serono growth hormone medication (Section 4).

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WARNING
• Whenyouhavenishedusingcool.click™2withpracticesolution,replacethenozzleand
piston before you proceed with delivering your growth hormone medication.
Section 4
DELIVERING YOUR DOSE OF EMD Serono GROWTH HORMONE [somatropin (rDNA
origin) FOR INJECTION]
WHAT YOU’LL LEARN
In this section, you’ll learn:
• howtochooseaninjectionsite
• howtollcool.click™2withyourdoseofgrowthhormone
• howtodeliveryourdoseofgrowthhormonewithcool.click™2
WHAT YOU’LL NEED
• cool.click™2device
• cartridge or vialwith reconstitutedsolution of your prescribed EMDSerono growth
hormone.
• Alcoholpreppad
How to deliver your dose of growth hormone with cool.click™ 2
Before delivering growth hormone with cool.click™ 2, be sure you are trained in using cool.
click™ 2, as described in section 3, “Demonstration and Practice” . You should use cool.click™ 2
for the administration of your EMD Serono growth hormone medication only after you are
comfortable using the device.
Choose an injection site
Decide where on your body to deliver the dose of growth hormone. Your doctor or nurse will
recommend what areas should be used and how often those areas should be rotated.
Your doctor or nurse may recommend using cool.click™ 2 at these delivery sites:
• Abdomen: use the areas around the
bellybutton, an inch or two away.
• Legs:selectaeshyareaonthefrontorside
of the thigh. Be seated with both feet on the
oor or with one leg crossed over the other.
• RearEnd:beseatedonchairandleanforward.
Use the upper, outer section of your rear
end.
• Arms:beseatedonachair,andndaposition
where you can comfortably reach a eshy area
on the back of the arm.
Keep a record of which part of the body you select
every time you use cool.click™ 2.
Fill Your Dose
Using your cartridge or vial of reconstituted solution of growth hormone repeat carefully the
same steps done described in the “Filling your dose” section.
Deliver the dose of EMD Serono growth hormone
1. Clean the delivery site with an alcohol wipe using a circular motion. Wait for the skin to dry
before using cool.click™ 2.

- 11 - PCT-193 L3-0308
2. Hold the handgrip on the rear housing of cool.click™ 2. Place the nozzle against the skin at
the chosen injection site and push the rear housing towards the injection site. You will feel
the rear housing slide forwards slightly. Note that the rear housing must be in this position
before the delivery can be made.
Note: without downward or forward pressure the device will not re. This is a security feature.
It will prevent the device from ring if injection button is accidentally hit or bumped.
3. Maintain this pressure on the injection site so that the skin is slightly depressed and has a
slight dimple. Press the release button rmly. This will deliver the injection. Delivery takes
less than a second. You may experience a slight sensation as the delivery is made.
4. Hold the nozzle against the skin, maintaining the pressure, for approximately 3 seconds
before removing.
It is normal to observe slight pinprick bleeding after delivery. A raised white bump on the skin
immediately after delivery indicates that the delivery was dermal instead of subcutaneous,
and wetness around the delivery site indicates incomplete delivery. Both can be caused by
using insucient pressure of the nozzle against the skin, or movement of the nozzle during
delivery. It is important that the delivery technique is corrected to avoid such conditions.
FPlease refer as well to the section
“What to do if you have a skin reaction”, Section 6.
5. After delivering the dose, hold pressure on the site for 30 seconds using three ngers over
a sterile gauze pad.
IMPORTANT
• Injectyourdoseimmediatelyafterhavinglledthenozzlewiththegrowthhormonesolution.
If you leave cool.click™ 2 sitting for more than 5 minutes the device will go into a rest mode
with a blank display. You may reactivate the display by pressing the yellow ON/OFF switch
and you can still administer your dose. If you leave cool.click™ 2 sitting for more than 15
minutes the device will turn o. You may switch on the device by pressing the yellow ON/
OFF switch. However the display will show its initial status with “8.8.8” ashing. You can still
administer your dose.
• Neverpresscool.click™2’sreleasebuttonwithoutthenozzleattached.
• Neverpresscool.click™2’sreleasebuttonwithairbubblesinsidethenozzle.
• Donotoverllcool.click™2pastyourspecicdose.Ifyoudo,movealloftheliquidbackinto
the cartridge or into the vial and re-set the correct dose.
• AlwaysdiscardthenozzleandpistonaccordingtotheInstructionforUseaccompanying
the nozzle and piston pack.
• Alwaystthecapfullyonthecool.click™2whennotinuse.

- 12 - PCT-193 L3-0308
• Safelydisposeofusednozzleandpistonasdirectedbyyourhealthcareprovider.Donot
reuse or re-sterilize after removal from cool.click™ 2.
WARNING
• Donotsharethesamenozzle,piston,cartridgeconnectororvialconnectorbetweendierent
individuals.
• Aswithanyinjectiondevice,improperuseofcool.click™2mayresultininjury,including
the transmission of infectious blood-borne diseases. Adhere to strict safety and anti-septic
precautions at all times.
CAUTION
• Holdcool.click™2inplaceagainsttheskinfor3secondsafterpushingthereleasebutton
to ensure proper delivery and avoid delivery site reactions.
• Donotpinchtheskinwhendeliveringthedose.
• Toavoidinjuryordamagetocool.click™2,onlypresscool.click™2’sreleasebuttonwhenthe
device is lled with the prescribed amount of liquid.
Section 5
MAINTENANCE AND CARE
WHAT YOU’LL LEARN
In this section, you’ll learn:
• howtostorecool.click™2
• howtochangethenozzleandpiston
• howtoreplacethebattery
How to store cool.click™ 2
After delivering your dose with cool.click™ 2 proceed with the following steps:
1. Press continuously the yellow ON/OFF switch until the display electronics shut down. In any
case the display electronics will shut down automatically after approximately 5 minutes, thus
preserving the battery life.
2. Clean the end of the nozzle with an alcohol wipe or, if required, remove the nozzle and piston
and discard it (refer to the Instruction for Use accompanying your nozzle and piston pack
about when and how often you must change the nozzle and piston).
3. Place the cap back on cool.click™ 2 and store in its storage box at room temperature and in
a safe place indoors.
CAUTION
• Avoidstorageat lowtemperature(below 50°F/10°C)or high temperature (above
104°F/40°C).
• Avoidstorageinahighhumidityenvironmentsuchasbathroomorsauna.
• Keepcool.click™2clean.Youcancleanthebodyofthedevicewithadampclothandmild
detergent. Dry well.
• Neversubmergecool.click™2inwater.Theinsideofthedeviceshouldnevergetwet.

- 13 - PCT-193 L3-0308
• Neverplacecool.click™2intherefrigeratorandneverleaveitexposedtodirectsunlightfor
a long time.
• Alwaysstorecool.click™2initsstorageboxwhennotusedandfortravel.
• Replacecool.click™2afterthreeyearsofuseorsoonerifthedevicefunctionsimproperly.
For replacement information, please call EMD Serono’s Connections for Growth® toll-free
at 800-582-7989 or Serocare
SM
toll-free at 800-714-2437.
How to change the nozzle and piston
CAUTION
• PleasefollowstrictlytheInstructionforUseaccompanyingyournozzleandpistonpack
about when and how often you must change the nozzle and piston.
1. In order to remove the nozzle, pull back the nozzle locks and withdraw the nozzle. This will
expose the piston.
2. Safely dispose of the nozzle.
3. Remove the piston by pushing to one side so that it snaps out of the cool.click™ 2.
4. Safely dispose of the piston.
The cool.click™ 2 is now ready for tting a new nozzle and piston assembly.
How to replace the battery
The cool.click™ 2 is supplied with a battery installed..
However, should the battery getting low, the display will show either:
“0.00” and “bAT” ashing alternatively, when you switch cool.click™ 2 on, in accordance to step
2 in the section
“Filling your dose”
or
“8.8.8” and “bAT” ashing alternatively, when you are already operating cool.click™ 2.
This warns that the battery needs to be replaced. Nevertheless you can still continue to operate
cool.click™ 2 normally and to inject your dose.
Should the battery getting low and the display shows “bAT” steadily, and it will not be possible
to operate cool.click™ 2. The battery must be replaced before you can operate cool.click™ 2 and
inject your dose.
To replace the battery perform as instructed hereafter:
1. Use the dose setting key supplied with the device, which was used for setting the dose range,
to withdraw the battery housing.
2. Remove the battery and t a new CR2032 coin cell battery (3V lithium), making sure that
the orientation is the same as the old battery

- 14 - PCT-193 L3-0308
3. Push the battery housing back into place until it clicks. This process is shown below.
IMPORTANT
Do not throw away the battery with household waste. Dispose of the used battery through
proper recycling methods.
Section 6
Frequently Asked Questions (FAQs)
WHAT YOU’LL LEARN
In this section, you’ll learn:
• howcool.click™2worksaswellassomeusefultipsonhowtoovercomeanyslightproblems
that you may encounter when using cool.click™ 2
and furthermore:
• whattodoifyouareexperiencingbruisingorstinging
• whattodoifyourskiniswetafterdeliveringadose
• whattodoifyouseebubblesinreconstitutedsolutionofgrowthhormone
• whattodoifyouhaveaskinreaction
How does cool.click™ 2 inject growth hormone?
The rear housing of cool.click™ 2 is rotated to wind up a spring that is used to power the device.
The discharge of the spring forces a ne stream of the growth hormone solution through an
orice in the nozzle at high pressure, so that the growth hormone solution penetrates the skin
and injects it to the subcutaneous layer of tissue.
The potential problems that you may encounter with cool.click™ 2 can usually be overcome just
by ensuring that your injection technique is correct.
You may need to practice several times in order to perfect your technique to ensure a comfortable,
complete injection. The main points to consider when perfecting your injection technique are:
• Wasthetipofthenozzlermlypressedagainsttheinjectionsiteat90°totheskinsurface?
• Wasthecool.click™2keptstillthroughouttheinjection?
• Wasthecool.click™2heldinpositionfor3secondsfollowinginjection?
• Didyouremembertorotatethecool.click™2onefullrotationpastyourdosebeforewinding
backtothecorrectamount?
• Didyoucheckthenozzlewasfreefromairbubblespriortoinjection?
• Wasthenozzlewipedwithanalcoholwipebeforestoringorafteruse?
• Hasthenozzleandpistonbeenchangedaccordingtoguidelinesorrecommendation?
If you are condent your technique was good, try using other injection sites.
What to do if you are experiencing bruising or stinging
If you are experiencing bruising or stinging when using cool.click™ 2, check the following:
• Youmightbepushingnozzletoohardagainsttheskin.Youonlyhaveuseenoughpressure
to push the rear housing towards the injection site.
• Yourmusclesmaybetootense.Attempttorelaxyourselforencourageyourchildtorelax.
It may be helpful to use distractions such as headphones or television.
• Youmaybechoosingasitethatcontainsmoremusclethanfat.Reviewthesuggesteddelivery
sites –in section 4,
“Choose an injection site”.
• Thenozzlemaybepartiallycloggedandmayneedtobereplaced.
If these suggestions do not solve your bruising or stinging problem, call Connections for Growth®
toll free at 800-582-7989 or Serocare
SM
toll-free at 800-714-2437 for referral to the EMD Serono
Nurse Network or consult your doctor or nurse.

- 15 - PCT-193 L3-0308
What to do if your skin is wet after delivering a dose
Some moisture at the delivery site or a small amount of uid, equivalent to what you might see at
the tip of a needle, is normal. If you see excessive moisture, ensure that your injection technique
is correct by following the instructions for use. Check particularly the following:
• Youmightbemovingcool.click™2duringdelivery.Holdcool.click™2steadywhileyoupress
the release button.
• Youmightbemovingcool.click™2awaytoosoonafterdelivery.Keepitinplaceforatleast
three seconds after you press the release button.
If moisture persists, you may talk to your doctor or nurse about technique.
What to do if you see bubbles in reconstituted solution of growth hormone
Always look at the liquid inside the nozzle after lling cool.click™ 2. The space between the tip of
the piston and the end of the nozzle should be lled with liquid and not air bubbles.
CAUTION
If you see air bubbles in the nozzle, wind one full turn further, then tap it gently to release bubbles
and then wind back until the required dose is indicated on the display. If there is still air present,
repeat until all air is expelled.
What to do if you have a skin reaction
Normally cool.click™ 2 produces a momentary sensation during delivery. It may be totally painless
or you may feel a pressure sensation or slight ick. It is normal to observe:
• slightmoisture
• minorbleeding
• araised,whitebumpthesizeofapinhead
• whiteorreddisharea
Uncommon reactions you should watch out for include:
• alarge,white,raisedbumpatthedeliverysite,seegurehereafter
• signicantliquidleakingordrippingatthedeliverysite
Often, these reactions are caused by improper technique. If you see any of these reactions,
review this instructions for use, talk to your doctor or nurse, or call EMD Serono Connections
for Growth® toll-free at 800-582-7989 or Serocare
SM
toll-free at 800-714-2437.
IMPORTANT
• Ifthenozzlegetsclogged,simplyreplaceitwithanewnozzleandpistonset.
• Ifyourcool.click™2doesn’tworkproperly,callEMDSeronoConnectionsforGrowth®toll-
free at 800-582-7989 or Serocare
SM
toll-free at 800-714-2437 for a replacement.
Section 7
RESOURCES
THE EMD SERONO PATIENT ASSISTANCE AND GROWTH SUPPORT™ PROGRAMS.
Growth disorders can raise many questions and concerns for patient families and caregivers –
from how to use medication properly to insurance reimbursement. Through the Connections for
Growth® and SerocareSM programs in the US, EMD Serono provides information and services
to help parents and their children, including:
• educationalmaterials
• reconstitutionanddosageinformation
• reimbursementsupport
• contactinformationforyourlocalnurseintheEMDSeronoNurseNetwork

- 16 - PCT-193 L3-0308
EMD Serono representatives will help you with reimbursement and billing issues.
Connections for Growth® and SerocareSM provide referrals to the EMD Serono Nurse Network
in your area. Nurses in the Nurse Network can answer your questions about proper use
and maintenance of cool.click™ 2, and can help you work through any problems you may
experience.
ConnectionsforGrowth®Toll-free:800-582-7989(US)•Website:www.howkidsgrow.com
Serocare
SM
Tollfree:800-714-2437(US)•Website:www.serostim.com.
Section 8
QUICK GUIDE
HOW TO DELIVER YOUR DOSE
Using cool.click™ 2 - Preparation and Delivery
1. Rotate the rear housing to move toward the front housing as far as it
will go. A slight click may be heard.
2. Switch on the device, the display should show 0.00. If the display shows
8.8.8 ashing, further tighten the rear housing.
3. Connect the nozzle to the cartridge connector (as shown) or vial
connector.
4. Draw the solution of growth hormone medication into the nozzle. The
display will indicate the dosage drawn.
5. Wind one full turn past your dose setting and release any air bubbles
in the nozzle by tapping gently with your nger.
6. Wind back to your required dose. If air bubbles are still present in the nozzle, repeat step
5 until all air bubbles are gone.

- 17 - PCT-193 L3-0308
7. Remove the nozzle from the cartridge connector (as shown) or vial
connector; the device is ready to deliver.
8. Clean the injection site with an alcohol wipe and wait for the skin to dry before using cool.
click™ 2.
9. Place the nozzle against the skin at your chosen injection site and press
the release button rmly. Forward or downward pressure is needed
for device to re.
10. Hold the nozzle against the skin for approximately 3 seconds before removing.
11. After delivering the dose, hold pressure on the site for 30 seconds
using a sterile gauze pad.
12. Clean the nozzle with the alcohol wipe. Recap device and store in its carrying case.

- 18 - PCT-193 L3-0308
HELPFUL TIPS
• Getsupplieslineduponaclean,drysurface:
- cool.click™ 2 device
- nozzle and piston set
- cartridge connector or Reconstitution Kit
- Sterile gauze pad or cotton ball
- alcohol wipe or prep pad
• Neverpressthecool.click™2releasebuttonwithoutthenozzleattached
• Neverpressthecool.click™2releasebuttonwithairbubblesinsidethenozzle
• Alwayslookattheliquidinsidethenozzle.Thespacebetweenthepistontipandtheend
of the nozzle should be lled with liquid and not air bubbles.
• Ifyouoverllcool.click™2,simplymovealltheliquidbackintothecartridgeorvialand
re-set to your correct dose.
• Alwaysplacethecapfullyonthecool.click™2whennotinuse.
• Please readInstructions for useforcompleteinstructions, warnings,and important
information.
• Pleaseseefullprescribinginformationforyourproduct.
• Questions:
- Call EMD Serono Connections for Growth
®
toll free at 800-582-7989 or Serocare
SM
toll
free at 800-714-2437
• Websites:
- howkidsgrow.com
- saizenus.com
- serostim.com