EMD Serono cool.click 2 Скачать руководство пользователя страница 8 | Manualshive

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EMD Serono cool.click 2 Скачать руководство пользователя страница 8

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PCT-193 L3-0308

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 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.

Attaching the nozzle and piston

F

Please 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 figure 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 firmly 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 fitted 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 fitted to the cool.click™ 2 together.

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Содержание cool.click 2

Страница 1: ...ly 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 ...

Страница 2: ...front view rear view cap removed Dose Display Cap Rear Housing Release Buttom Battery Housing On Off Switch Front Housing Nozzle Locks Nozzle in storage box Storage Box Dose Setting Key ...

Страница 3: ... 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 ...

Страница 4: ...u feel confident 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 wit...

Страница 5: ... 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 T...

Страница 6: ...ol click 2 Setting Required Product Fixed Volume of Diluent ml Fixed Concentration mg ml Milligram Dose Increments Doses Feasible per Injection B Saizen 8 8 mg click easy 1 51 ml 5 83 mg ml 0 02 mg 0 30 2 92 mg D Saizen 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...

Страница 7: ...F switch the display will step through the following sequence and repeat SEL à ml à A m g à B mg à C mg à D mg à E mg à F mg à repeat F Please note if you press and hold the yellow ON OFF switch too long the display will turn off 6 Once the required setting is shown push the key in again and then withdraw the key The display will briefly blank and then stops flashing This confirms the setting and ...

Страница 8: ... 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 firmly 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 clic...

Страница 9: ...blister pack Do not use the connector if the blister pack is open or appears damaged 1 Priortousingeithercartridgeconnectororvialconnectorcheckthattheexpirydate indicated by the sandglass symbol has not expired 2 Then fit 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 I...

Страница 10: ...gently with your fingers 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 fit the protective cap onto cartridge or vial T...

Страница 11: ...e 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 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 be made Note without downward or forward pressure the device...

Страница 12: ...on 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...

Страница 13: ...zzle against the skin or movement of the nozzle during delivery It is important that the delivery technique is corrected to avoid such conditions F Please 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 fingers over a sterile gauze pad IMPORTANT Injectyourdoseimmediatelyafterhavingfilledt...

Страница 14: ...e 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 Cl...

Страница 15: ... cool click 2 is now ready for fitting 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 flashing 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 flashing alternatively when you are a...

Страница 16: ...der when perfecting your injection technique are Was the tip of the nozzle firmly 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 c...

Страница 17: ...ensationduringdelivery Itmaybetotallypainless or you may feel a pressure sensation or slight flick 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 figure hereafter significant liquid leaking or dripping at the delivery site Of...

Страница 18: ...UIDE 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 Switchonthedevice thedisplayshouldshow0 00 Ifthedisplayshows 8 8 8 flashing further tighten the rear housing 3 Connect the nozzle to the cartridge connector as shown or vial connector 4 Draw the solution of growth ho...

Страница 19: ...ol click 2 9 Placethenozzleagainsttheskinatyourchoseninjectionsiteandpress the release button firmly Forward or downward pressure is needed for device to fire 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 ...

Страница 20: ...zzle The space between the piston tip and the end of the nozzle should be filled with liquid and not air bubbles If you overfill 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...

Страница 21: ... 19 PCT 193 L3 0308 ...

Страница 22: ... 20 PCT 193 L3 0308 ...

Страница 23: ...PCT 193 L3 0308 EMD Serono Inc Rockland MA 02370 cool click is a trademark of EMD Serono Inc ...

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