EMD Serono Easypod User manual

Instructions For Use
800-582-7989
Questions about
easypod™? excl sively for se with
www.easypod s.com click.easy®cartridges 8.8 mg

Q ick Contacts
Defa lt Settings Table
For additional Serofine™ needles
Call Connections for Growth®…….800-582-7989
If easypod™does not work properly
Call Connections for Growth………800-582-7989
Your easypod comes programmed with the following default settings.
These settings may be changed to suit your individual preference.
Note: Clinical settings should be changed only under guidance from your healthcare provider.
Clinical settings Defa lt
Dose settings
Daily dose 0.15 mg
eight 1 kg
Height 1 cm
Posology (Pos) 0.025 mg/kg/day or
0.7 mg/m2/day
Frequency 7 days/week
Dose adjustment Off
Cartridge B (5.83 mg/mL)
Needle type 29 G x 12 mm
Cartridge expiration 28 days
Dose log On
PIN code 0000
Comfort settings Defa lt
Needle speed Medium
Injection speed Medium
Injection depth 6 mm
Injection time 5 seconds
Device settings Defa lt
Date & Time day/month/year
Sound On
Name easypod
elcome picture easypod
Language English

Table of Contents
A Message about easypod™ to Saizen®[somatropin (r NA origin) for injection]
Patients and their Caregivers ................................................................2
Section 1. Getting Started
Getting to know easypod . . . . . . . . . . . . . . . . . . . . 4
First-time use of easypod . . . . . . . . . . . . . . . . . . . 5
ose history and Battery status settings ..... 6
Comfort settings ............................7
Needle speed ..............................8
Injection speed ............................8
Injection depth ............................9
Injection time ..............................9
evice settings ............................ 10
ate & Time ..............................11
Sound ...................................12
Name ....................................12
Welcome picture ......................... 13
Language ................................13
Clinical settings ............................14
PIN code ...............................14
ose settings .............................15
Input in mg ............................16
By weight ..............................16
By body surface ........................17
Check settings .........................17
ose adjustment .......................18
Injection settings .........................20
Cartridge ..............................21
Needle type ............................22
Cartridge expiration ....................23
ose log ...............................23
1
Teach me – a pictorial
demonstration built into easypod ..........24
Section 2.
Delivering Saizen with easypod
Preparing for your injection ................25
Giving your daily injection in three steps . . . . 26
Step 1: Attach the needle ..................26
Step 2: Inject .............................27
Step 3: etach the needle .................28
After your injection ........................29
Partial dose ................................30
Section 3.
Maintenance, Care, and Handling of easypod
Traveling with easypod .................31
Manual removal of an in-use cartridge ....31
Insertion of a new cartridge or
change of an empty/expired cartridge ....32
Replacing the batteries ................33
Storage .............................33
Replacement of easypod ...............34
Frequently asked questions .............34
Section 4.
Technical Information about easypod .......37

2
•easypod is a smart injector, which means it automatically inserts a needle and
delivers a preset dose of Saizen®. Your easypod is a personal device; for use
by one person only.
•easypod should only be used according to this instruction manual and only after
proper training from a healthcare provider. For children, an adult should supervise
the use of easypod.
The “Teach me” section (see page 24) may be used to review the formal training
you received.
•easypod is to be used exclusively with Saizen click.easy®cartridges, in accordance
with the prescription written by your healthcare provider. Prior to delivery with easypod,
Saizen must be reconstituted (mixed) using click.easy. Be sure to write the date of
reconstitution on the transparent inner label on the click.easy cartridge. easypod is not
designed for use with any other cartridges.
etailed information about reconstitution and administration of Saizen is provided in the
Saizen Package Insert and the click.easy Instructions for Use.
•easypod is compatible with Saizen click.easy cartridges in the following concentrations:
(a) 8 mg/mL; (b) 5.83 mg/mL; and, (c) 1.5 mg/mL. You should check the expiration date
printed on the click.easy carton prior to use.
•easypod should be handled with care. When possible, store easypod in the storage case
provided, which limits exposure to dirt, dust, liquid, and other substances.
A Message about easypod™to Saizen®[somatropin (r NA origin) for injection]
Patients and their Caregivers

3
•As needed, clean easypod™with a damp cloth and mild soap solution.
o not use harsh chemicals, cleaning solvents, strong detergents, or alcohol
solutions, as these could damage easypod. Remove dirt and dust from your
easypod with a soft brush.
CAUTION: Never rinse or immerse easypod or any of its parts in water.
•easypod contains no harmful components.
•easypod should be replaced after three years of use. A new easypod can be obtained
through your healthcare provider, or through Connections for Growth®(CFG), the
patient-support program provided by EM Serono. Call CFG toll-free at 800-582-7989.
•easypod should only be used with Serofine™single-use, disposable sterile needles,
0.33 x 12 mm (29 G x 1/2") or 0.30 x 8 mm (30 Gx5/16"). Call Connections for Growth
at 800-582-7989 to refill your supply of needles. ispose of used needles safely and
appropriately as recommended by your healthcare provider. easypod is not designed
for use with other needles.
When a needle is attached, and prior to injection, keep the needle and the base of
easypod pointing down.
WARNING:
•easypod is an electromechanical device and should be handled with care. Do not use easypod
if it does not work properly and do not attempt to repair a faulty easypod.
•easypod should not be turned on near strong electromagnetic sources like an x-ray machine in
a medical facility or a security machine at an airport. Use of easypod near common-household
electronic devices should not be a problem.