Related Manuals for EMD Serono cool.click 2
Summary of Contents for EMD Serono cool.click 2
- Page 1 Instructions for Use Totally Needle-Free cool.click™ 2 Needle-Free Growth Hormone Delivery Device Exclusively for use with EMD Serono Products containing Growth Hormone [somatropin (rDNA origin) for injection] RX only...
- Page 2 FRoNT viEw Rear Housing Release Buttom REAR viEw Dose Display Battery Housing cAP REMovED iN SToRAGE boX Storage Box On/Off Switch Front Housing Nozzle Locks Nozzle Dose Setting Key...
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Page 3: Table Of Contents
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... - Page 4 To cool.click™ 2 NEEDLE-FREE DELivERY DEvicE • 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. 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 must only be used with EMD Serono growth hormone and not any other brand of human growth hormone or medication.
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Page 5: Section 1 Getting Started With Cool.click
(mg) of growth hormone, Table 1, or milliliter (ml) of liquid dose, Table 2, which is specific to the • How to fill cool.click™ 2 with your dose EMD Serono growth hormone medication that your doctor has prescribed for you. • How to practice using cool.click™ 2 with a practice cartridge (or vial) cool.click™ 2 can be set to one of six different dose ranges, indicated by the letters A to F at the wHAT YoU’LL NEED... - Page 6 • You must set the dose range applicable for the EMD Serono growth hormone medication • Then, to set the appropriate dose range, follow the instructions provided in the section that your doctor has prescribed you. Please look carefully at Table 1 and Table 2 hereafter entitled Setting the dose range. that list the various growth hormone medications. Search for your prescribed medication • Your physician or nurse will set the device for you, do not set the device without guidance and note the corresponding setting (e.g. B, D, ml…). from a nurse or physician trainer.
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Page 7: Setting The Dose Range
Setting the dose range 5. Press the yellow ON/OFF switch. The display will indicate 0.00 with “ml” flashing. Press the ON/OFF switch again and the display will show “mg” plus “A” flashing. Repeat this until the 1. With the cap in place, hold the cap and front housing in one hand and the rear housing in required setting is shown. -
Page 8: Attaching The Nozzle And Piston
• 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 different 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. -
Page 9: Fitting The Cartridge Connector Or The Vial Connector
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™... - Page 10 3. Remove the protective cap from the cartridge connector (as shown) or vial connector. 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. 4.
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Page 11: Section 3 Demonstration And Practice
2 still—firmly, 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 • Once you feel comfortable using cool.click™ 2 practicing with practice solution, you are ready be made. to administer your prescribed EMD Serono growth hormone medication (Section 4). - 9 - PCT-193 L3-0308... -
Page 12: Section 4 Delivering Your Dose
Deliver the dose of EMD Serono growth hormone for the administration of your EMD Serono growth hormone medication only after you are 1. Clean the delivery site with an alcohol wipe using a circular motion. Wait for the skin to dry comfortable using the device. - Page 13 2. Hold the handgrip on the rear housing of cool.click™ 2. Place the nozzle against the skin at using insufficient pressure of the nozzle against the skin, or movement of the nozzle during the chosen injection site and push the rear housing towards the injection site. You will feel delivery.
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Page 14: Section 5 Maintenance And Care
• Safely dispose of used nozzle and piston as directed by your healthcare provider. Do not 1. Press continuously the yellow ON/OFF switch until the display electronics shut down. In any reuse or re-sterilize after removal from cool.click™ 2. case the display electronics will shut down automatically after approximately 5 minutes, thus preserving the battery life. wARNiNG • Do not share the same nozzle, piston, cartridge connector or vial connector between different individuals. - Page 15 How to replace the battery • Replace cool.click™ 2 after three years of use or sooner if the device functions improperly. The cool.click™ 2 is supplied with a battery installed.. For replacement information, please call EMD Serono’s Connections for Growth® toll-free However, should the battery getting low, the display will show either: at 800-582-7989 or Serocare toll-free at 800-714-2437.
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Page 16: Section 6 Frequently Asked Questions (Faqs)
The rear housing of cool.click™ 2 is rotated to wind up a spring that is used to power the device. toll free at 800-582-7989 or Serocare toll-free at 800-714-2437 for referral to the EMD Serono The discharge of the spring forces a fine stream of the growth hormone solution through an Nurse Network or consult your doctor or nurse. -
Page 17: Section 7 Resources
Often, these reactions are caused by improper technique. If you see any of these reactions, three seconds after you press the release button. review this instructions for use, talk to your doctor or nurse, or call EMD Serono Connections If moisture persists, you may talk to your doctor or nurse about technique. -
Page 18: Section 8 Quick Guide
EMD Serono representatives will help you with reimbursement and billing issues. 3. Connect the nozzle to the cartridge connector (as shown) or vial Connections for Growth® and SerocareSM provide referrals to the EMD Serono Nurse Network connector. in your area. Nurses in the Nurse Network can answer your questions about proper use and maintenance of cool.click™... - Page 19 7. Remove the nozzle from the cartridge connector (as shown) or vial 11. After delivering the dose, hold pressure on the site for 30 seconds connector; the device is ready to deliver. using a sterile gauze pad. 8. Clean the injection site with an alcohol wipe and wait for the skin to dry before using cool. 12.
- Page 20 • 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 toll ® free at 800-714-2437 • Websites: - howkidsgrow.com...
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- Page 23 EMD Serono, Inc. Rockland, MA 02370 cool.click™ is a trademark of EMD Serono, Inc. PCT-193 L3-0308...
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