1
BETACONNECT
TM
Instructions for use
Language: English
Version: 2013-10
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Table of Contents
Chapter 1: First Time Use........................................................................................... 4
1.1. First time use of BETACONNECTTM ............................................................. 4
1.2. Operator Profile and Applied parts ................................................................ 4
1.3. Intended Use ................................................................................................. 4
Chapter 2: Things you should know about the BETACONNECTTM ............................ 5
2.1. Overview ....................................................................................................... 5
2.2. Which syringe can be used with the BETACONNECTTM? / Injection volumes
5
2.3. Charging the BETACONNECTTM .................................................................. 6
2.4. Care, storage and disposal ............................................................................ 6
2.5. Cleaning ........................................................................................................ 7
Chapter 3: Injection Process ....................................................................................... 8
3.1. Preparing BETACONNECTTM for injection .................................................... 8
3.2. Injection procedure ........................................................................................ 9
3.3. Removing the used syringe and needle ...................................................... 10
Chapter 4: Adjustments ............................................................................................ 12
4. .................................................................................................................... 12
4.1. Adjusting the injection depth ........................................................................ 12
4.2. Adjusting the injection speed ....................................................................... 12
4.3. Setting the reminder function ....................................................................... 13
Chapter 5: Trouble shooting ..................................................................................... 14
Chapter 6: Technical Specifications ......................................................................... 16
6.1. Labeling ....................................................................................................... 16
6.2. Technical Specification ................................................................................ 17
3
Important notes
Warning!
Whenever you see this symbol it means that safety instructions must be followed.
Please read these instructions prior to using BETACONNECT
TM
for the first time. Please keep these
instructions in a safe place.
Keep these Instructions for Use for future reference.
The BETACONNECTTM reminder function is only intended as a supplement to any memory system that
you currently use to remind yourself to take your Betaseron®. You will maintain full responsibility to
administer your medication at the appropriate time and to follow the instructions from your Healthcare
Professional.
Use only syringes provided with your Betaseron® with the BETACONNECTTM.
Caution, the syringes are made of glass and can break if dropped or hit too hard.
The BETACONNECT
TM
must never be pointed at another person or yourself except in order to inject
Betaseron®
The BETACONNECT
The BETACONNECT
The BETACONNECT
TM
is not intended for use on more than one patient (danger of infection).
TM
cannot be sterilized.
TM
may not be opened or repaired as no modification of this equipment is allowed.
The batteries are not replaceable.
This BETACONNECTTM contains re-chargeable batteries. Do not expose to extreme heat or fire. Avoid
storage in direct sunlight.
The BETACONNECT
TM
is not recommended for the blind or visually impaired without the assistance of a
sighted individual trained to use it.
Keep the BETACONNECTTM and the accessories (e.g. cables) out of reach of children. The cables can
lead to possible strangulation.
The BETACONNECT
TM
is an electronic device and must be handled with care.
Do not use the BETACONNECTTM if, during normal use or during recharging, it does not function in
accordance with the instructions or if it seems to be damaged.
Do not use charger and cables other than those provided with the BETACONNECTTM as this may result
in increased emission, decreased immunity and reduced electrical safety of the BETACONNECTTM.
For correct function of BETACONNECTTM you must keep the safety release at the front of the
BETACONNECT
TM
clean using a dry/damp cloth or alcohol wipe.
Only inject into bare skin do not inject through clothes.
Do not use the BETACONNECTTM in oxygen rich environment.
Do not use the BETACONNECT
TM
if:
The prefilled syringe cannot be inserted or removed as described.
The syringe was not completely emptied during the last attempt to use the BETACONNECTTM. Note if
the injection has been interrupted, the syringe will not be completely emptied.
If unexpected events occur or BETACONNECTTM does not operate as described in this instruction for
use.
4
Chapter 1: First Time Use
1.1. First time use of BETACONNECTTM
Important: Fully charge the BETACONNECT
TM
(by plugging the micro USB cable and charger into a power
outlet) for approximately 2 hours before using it for the first time. Four green bars indicate the
BETACONNECTTM is fully charged.
The folder box contains the following items:
BETACONNECTTM
Packaging to store your BETACONNECTTM
Charger to charge your BETACONNECTTM
USB cable
Quick guide
Instruction for use.
Remove your BETACONNECTTM from its package.
1.2. Operator Profile and Applied parts
BETACONNECTTM is designed to be used by MS patients (tested with MS patients from 18 years onwards), who
have been found capable by MS nurses / health care professionals to operate and perform injections using
BETACONNECTTM. These patients should be able to perform the reconstitution and preparation of the disposable
(user filled) syringe to the proper dose prescribed by their healthcare provider.
Applied parts (parts that come in contact to the skin) are the Safety release, Housing and the Buttons.
1.3. Intended Use
The re-usable electronic autoinjector is intended to help the user by automating subcutaneous injection using a
user filled disposable syringe (provided in the Betaseron® package). The BETACONNECTTM is intended for use
by an individual as a portable device (normally used at home).
• Application by patient (user) or caregiver.
• Injection sites: abdomen, thigh, buttocks, upper arm (see also the Betaseron® patient information leaflet).
• Short time in contact with skin at injection site every other day.
The BETACONNECTTM is an application aid that allows patients to inject their medication
subcutaneously using a user filled disposable syringe.
The BETACONNECTTM provides a visual and acoustic reminder function (notification 48 h after
last injection). The visual and acoustic reminder function can be disabled.
5
Chapter 2: Things you should know about the BETACONNECTTM
2.1. Overview
On/off button
Injection button
Light bar
Blue lid release button
Safety release
Needle depth setting
Injection speed setting
Reminder on/off
Prepared syringe
BETACONNECTTM allows needle insertion depths of 8, 10 and 12 mm. Before making any adjustments, please
read section ”Adjusting the insertion depth”.
BETACONNECTTM allows injection speed setting of slow, medium and fast injections. Before making any
adjustments please read section ”Adjusting the injection speed”.
The BETACONNECTTM
Indicates if recharging is necessary.
Reminds you 48hours after your last injection for one hour to take a new injection, but gives you the
option to disable the reminder function.
Will automatically power down if it is not operated for 20 minutes to save battery power.
The injection procedure used by the BETACONNECTTM is conducted in four stages which are carried out
automatically by the BETACONNECTTM:
Phase I Inserting the needle - the syringe is pushed forward so that the needle penetrates the skin.
Phase II Injecting the medication - the medication is injected subcutaneously (injection speed depends
on injection speed setting).
Phase III Dwell time - the needle briefly remains in the skin to allow the medication to be spread in the
subcutaneous skin tissue.
Phase IV Withdrawing the needle - the syringe and needle are withdrawn after injection. The
BETACONNECTTM will sound several short beeps and present a flashing blue light
bar visual after the needle was withdrawn.
2.2. Which syringe can be used with the BETACONNECTTM? / Injection volumes
Only use syringes (see picture below) provided with your Betaseron®. The syringes have to be
reconstituted per the Betaseron® patient information leaflet. Ask your MS nurse / healthcare professional
if you need help with this.
Adapter body
Needle Syringe
6
Step 1: Connect the supplied micro-USB cable
& charger.
To charge the BETACONNECTTM, plug the supplied USB
charger into your power outlet. Be sure to have the
BETACONNECTTM connected to the micro-USB cable &
charger.
When fully charged, the battery capacity should last
for approximately 15 to 20 injections (4-5 weeks).
It is recommended to fully charge your
BETACONNECTTM.
Step 2: Charging the BETACONNECTTM and
verify charging status
The light bar shows the charging status of the battery level
with four green lights.
Charging is complete when all four green lights are
solid and the BETACONNECTTM turns off.
Micro-USB port
Important: The BETACONNECTTM cannot be used for injection while charging. The BETACONNECTTM can be
recharged at a temperature from 10°C to 35°C / 50 – 95°F.
BETACONNECT
TM
is designed to injection volumes between 0.25 to 1.0 ml.
2.3.
Charging the BETACONNECT
TM
2.4. Care, storage and disposal
Your BETACONNECTTM can be stored at a temperature from – 10 to 40°C (14 - 104 °F), at a humidity
level of 20 to 93 % relative humidity, not condensing, and an atmospheric pressure range of 700 hPa to
1,060 hPa (525 mmHg to 795 mmHg).
Your BETACONNECTTM can be operated at a temperature from 5 to 40°C (41 - 104 °F), at a humidity
level of 15 to 93 %relative humidity, not condensing, and an atmospheric pressure range of 700 hPa to
1.060 hPa (525 mmHg to 795 mmHg).
Always store the BETACONNECTTM with the lid closed and in the BETACONNECT® packaging.
Protect the BETACONNECTTM from dust, dirt, extreme temperatures or direct sunlight.
If the BETACONNECT
on it) there is a risk of damaging the BETACONNECT
Your BETACONNECTTM is not watertight and should be kept dry. Do not submerge your
BETACONNECTTM in liquid.
Please follow local regulations for disposal of electronic waste. To protect natural resources and to
promote material reuse, please separate packaging material from other types of waste and recycle the
material through your local recycling system.
TM
is exposed to extreme vibrations, pressure or shock (e.g. dropping or stepping
TM
.
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2.5. Cleaning
For correct function of BETACONNECTTM you must keep the safety release clean using a clean damp
water cloth or alcohol wipe.
In case medication is spilled inside the BETACONNECTTM, it must be removed using a damp cloth.
Other parts of the BETACONNECTTM do not normally need to be cleaned; if needed, lightly dampen a
cloth with water and wipe the device.
Do not submerge the BETACONNECTTM in any liquid and do not sterilize the BETACONNECTTM.
8
Chapter 3: Injection Process
3.1. Preparing BETACONNECTTM for injection
Step 1: Turn On BETACONNECTTM
Press the on-/off button to start the BETACONNECTTM.
A short beep tells you that the BETACONNECTTM is
turned on.
BETACONNECT
TM
conducts a self-test each time the
BETACONNECT
TM
is turned on.
If the on-/off button blinks green continuously or light bar
blinks red, see the trouble shooting section on page 14.
Step 2: Check Battery Status
Check the battery status on the light bar.
Four green bars indicate the battery is fully charged.
If there is one green bar flashing in the light bar, there
is enough power for one injection but the
BETACONNECTTM must be recharged right after.
A flashing orange bar in the light bar indicates the
battery level is too low to perform an injection and the
BETACONNECTTM will shut-off. In this case the
BETACONNECTTM has to be charged before it can be
used.
Step 3: Open the lid
Fully open the lid by pressing the blue lid release button on the
side of the BETACONNECTTM.
Step 4: Insert Syringe
Place the syringe into the insertion area in the
BETACONNECTTM until it snaps into place. Leave the needle
cap on.
The syringe must be placed in such a way that it
matches the printed marking.
The lid will not close if the syringe is not seated
properly.
Check that the depth and speed settings are correct.
For depth and speed setting please read chapter 4
(Adjustments).
Turn On
Press to open lid
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Step 5: Illumination of injection button
Close the lid. You will hear a click when it shuts.
The injection button is illuminated with a steady blue
light. This means that the BETACONNECT
TM
is now
ready to be used for an injection.
The lid must be fully closed to administer an injection.
3.2. Injection procedure
Step 6: Clean the injection site
Clean the chosen injection area with an alcohol swab.
Step 7: Remove needle cap
Remove the needle cap by pulling it off at the front of the
BETACONNECTTM. Do not twist when removing the needle
cap.
Step 8: Place the BETACONNECTTM against the
injection site
Gently hold the BETACONNECT
TM
at a 90° angle against
the skin to activate the safety release.
The injection button illuminates with a flashing
blue light when the safety is released.
Make sure you hold the BETACONNECT
TM
against your skin for the entire injection.
Step 9: Start the Injection
Press and release the injection button to start the injection.
There is no need to keep the button pressed
during the injection process.
Injection button
Important: Be careful not to accidentally press the
injection button while removing the needle cap from the
BETACONNECTTM.
Important: Make sure not to accidentally touch the front of
the BETACONNECT
TM
when there is a syringe in it
because you may accidentally start the injection by
pressing the injection button.
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Step 9: Verify Injection Status
Four blue reducing illuminated lights show the injection
status.
Do not interrupt the injection. The injection cycle will be
interrupted by:
(Preliminary) Removing the BETACONNECTTM from
the injection site.
Pressing the on/off button.
Step 9: Completeness of Injection
Do not remove the BETACONNECT
TM
from the
injection site until the BETACONNECT® has indicated
that the injection is complete.
Withdrawing the needle - the syringe and needle are
withdrawn after the injection.
Upon injection completion, the BETACONNECTTM
will have two short beeps and a flashing blue light
bar.
The BETACONNECTTM will automatically power
down after the injection is completed.
3.3. Removing the used syringe and needle
Step 10: Open the lid
Fully open the lid by pressing the blue lid release button on the
side of the BETACONNECTTM.
Important: The injection procedure is quiet; therefore, the
light bar will give you the injection status.
Always hold the BETACONNECTTM perpendicular, at a
right angle, against your injection site during the entire
Push to open lid
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Step 11: Remove the used syringe
Remove the syringe by gently lifting it straight out of the
BETACONNECTTM.
Hold the BETACONNECTTM with your other hand
while removing the syringe
Important: Be careful not to get injured by the needle
when you remove the empty syringe.
Do not put the needle cap back on the syringe
Always dispose of your empty syringe immediately after
you completed your injection into an appropriate sharps
container.
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Chapter 4: Adjustments
Step 1: Open the lid fully
The setting allows injection depths of 8 mm, 10 mm
and 12 mm by moving the injection depth slider.
By default, BETACONNECTTM is set to the standard
injection depth of 12 mm. Discuss with your healthcare
provider if a different depth should be used prior to
changing the depth setting.
Step 2: Set the depth slider to the desired setting
Adjustment:
12 mm: Move the slider below the 12mm setting
10 mm: Move the slider below the 10mm setting
8 mm: Move the slider below the 8mm setting.
Step 1: Open the lid fully
The setting allows slow, medium and fast injections.
By default, BETACONNECTTM is set to the medium injection
speed. Discuss with your healthcare provider if a different
injection speed should be used prior to changing the injection
speed setting.
Step 2: Set the injection speed slider to the
desired setting
Adjustment:
Fast: Move slider below symbol.
Medium: Move slider below symbol.
Slow: Move slider below symbol.
Important: Check the settings prior to each injection to ensure you are injecting at the right injection depth and
injection speed recommended by your MS nurse /healthcare professional.
Insertion depth slider
Injection speed slider
4.1. Adjusting the injection depth
4.2. Adjusting the injection speed
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4.3. Setting the reminder function
Step 1: Open the lid fully
If the reminder function is activated, the BETACONNECT
TM
will remind you 48 hours after your last injection to take a new
injection.
This reminder function is reset after each injection and the 48
hours will start counting again.
By default, the reminder function of the BETACONNECTTM is
enabled.
Step 2: Set the reminder function to the desired
setting
Adjustment:
: Reminder function enabled
: Reminder function disabled
Step 3: Reminder feature
The reminder is an intermitting beep and a blue flashing light
at the top of the light bar.
The flashing light reminder lasts for one hour.
The beep occurs every 15 minutes for one hour.
You can mute the beep and still have the flashing
light reminder by pressing the injection button or
opening the lid.
To cancel both the beep and flashing light reminder,
press the on/off button.
Reminder enabled
Reminder signal
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Chapter 5: Trouble shooting
If assistance is needed during setting up, using, or maintaining the BETACONNECTTM contact your MS nurse /
Problem
Cause
Solution
It is not possible to turn on the
BETACONNECT
TM
by pressing
the on-/off button
1. On-/off-button was not
pressed long enough.
1. Firmly press the on-/off-button for
more than 2 seconds.
2. Battery is not charged.
2. Recharge the
BETACONNECTTM.
3. Battery or electronic failure.
3. Please contact your MS nurse /
healthcare professional for a
replacement.
BETACONNECT
TM
turns
automatically off.
1. BETACONNECT
TM
will
automatically turn off after 20
minutes of inactivity.
1. Press the on-/off-button to turn
on.
2. BETACONNECT
TM
will power
off if the battery level is too
low.
2. Recharge the BETACONNECT
TM
if the battery indicator is flashing
orange when you turn on the
BETACONNECTTM.
It is not possible to use the
BETACONNECTTM while being
charged
1. The BETACONNECT
TM
will
not operate when it is being
charged.
3. Charge the BETACONNECTTM
and remove charger before use.
It is not possible to open the lid
1. The lid cannot be opened
during the injection process.
1. Wait until the injection process is
completed.
2. The lid or the opening button
does not function.
2. Please contact your MS nurse /
healthcare professional for a
replacement.
It is not possible to inject by
activating the safety release
1. The safety release does not
function.
1. Please contact your MS nurse /
healthcare professional for a
replacement.
It is not possible to charge the
BETACONNECTTM
1. The wrong USB cable or
charger is used.
1. Make sure that the charger and
cables provided with the
BETACONNECT
TM
are used.
2. The USB connection is worn
out.
2. Please contact your MS nurse /
healthcare professional for a
replacement.
It is not possible to insert the
syringe into the
BETACONNECTTM
1. The wrong syringe type is
used.
1. Only use syringes provided with
your Betaseron® with the
BETACONNECTTM.
2. The syringe is not placed into
the insertion area correctly.
2. Make sure that the syringe is
lined up with the syringe outline
in the insertion area correctly.
The green light on the on-/off
button does not stop blinking
after the BETACONNECT
TM
was
turned on.
1. The self-test is not completed.
1. Make sure the safety release in
the front of the
BETACONNECTTM is not
pressed.
2. Make sure the lid is closed.
3. Make sure no buttons are
depressed.
healthcare professional.
15
Problem
Cause
Solution
4. Hold on-/off button to shut down
BETACONNECT
TM
and turn it on
again.
If the problem is not solved
contact your MS nurse /
healthcare professional.
A red blinking light is shown on
the BETACONNECTTM.
1. The injection procedure was
interrupted.
1. In case the injection was
interrupted ensure the entire dose
is injected. Consult your MS nurse
/ healthcare professional if the
entire dose was not received.
2. A malfunction was detected.
2. Hold the on-/off button down to
shut down BETACONNECT
TM
and turn it on again.
If the problem is not solved
contact your MS nurse /
healthcare professional.
An orange light is shown on the
BETACONNECTTM during
charging.
1. The temperature is too low or
too high.
1. The BETACONNECTTM can be
recharged at a temperature from
10°C to 35°C / 50 – 95°F.
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Chapter 6: Technical Specifications
6.1. Labeling
It is important that you read this instruction before you use the BETACONNECTTM.
The symbol is accompanied by an expiry date to indicate that the device should not be
used after the end of the indicated year (YYYY) and month (MM) printed as YYYY-MM.
Keep the BETACONNECTTM dry.
The product contains electrical and electronic components and must not be disposed of
using standard refuse collection. Please consult local directives/authorities for disposal of
electrical and electronic equipment. When disposing of electrical and electronic
equipment by use of the collection systems available in your country, you protect the
environment, human health and contribute to the prudent and rational use of natural
resources.
The BETACONNECTTM is a type BF device and provides protection against electrical
shock and electrical current leakage.
Manufacturer
The unique serial number of this BETACONNECTTM
The BETACONNECTTM complies with the requirements of The Medical Device Directive
(MDD 93/42/EEC), the Radio and Telecommunications Terminal Equipment Directive
(R&TTE 1999/5/EC), the EMC Directive (2004/108/EC) and the RoHS (Restriction of
Hazardous Substances) directive (2011/65/EU).
The BETACONNECTTM radiates non ionizing electromagnetic signals.
FCC ID: 2AAGY-
BETAC1
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
The BETACONNECTTM is IC-authorized under the listed grantee code showing
0543 0681
On your BETACONNECTTM/packaging the following symbols are used:
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IC: 3775E-BETAC1
compliance to Canadian regulations regarding Unlicensed Transmissions.
The BETACONNECTTM is authorized under the listed grantee code showing compliance
to the Japanese regulation regarding Low Power Communication System/ Wireless Lan
System.
The BETACONNECTTM can be operated at a temperature from 5 to 40°C / 41 - 104 °F.
The BETACONNECTTM can be stored at a temperature from – 10 to 40°C / 14 - 104 °F.
Type:
BETACONNECTTM, class IIa medical device in Europe or class II medical device in the
USA
Life time
3 years after manufacturing date
Serial Number (SN)
Please refer to the inside of the lid of your BETACONNECTTM
Size:
165 x 52 x 42 mm (approximately 6.496 x 2.047 x 1.654 Inch)
Weight:
Approx. 185 g / 6.4 oz.
Light Display:
Light-emitting diode (LED)
Power Supply
1 rechargeable internal Li-Ion battery.
Electromagnetic
Compatibility
The BETACONNECTTM meets the requirements of EN 60601-1-2
Like most electronic devices, using the BETACONNECT® in the immediate vicinity of
mobile phones or microwave appliances may result in impaired functioning. Use and
store BETACONNECT
TM
outside such an environment.
Mobile phones should, depending on their transmitting power, be kept at a distance of at
least 1 m / 3.28 ft.) from the BETACONNECTTM while it is in use.
Radio transmitting
hardware
Bluetooth 4.0 using a customized encrypted protocol.
Class B digital device
Bluetooth and USB communication can only be established using dedicated software,
contact your MS nurse / healthcare professional.
6.2. Technical Specification
Expiry and disclaimer
After the expiry date your BETACONNECTTM has to be replaced. Contact your MS nurse / healthcare
professional to receive a new BETACONNECTTM. The expiry date can be located inside the lid indicated by year
(YYYY) and month (MM) printed as YYYY-MM.
The BETACONNECTTM reminder function is only intended as a supplement to any memory system that you
currently use to remind you to take your Betaseron®. This does not relieve you from your responsibility to take
your Betaseron® as directed by the Patient Information Leaflet. The correct application of Betaseron® according to
such instructions shall remain your sole responsibility.
Bang & Olufsen Medicom shall have no liability for incidental or consequential damages. Some states may not
allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to
you.
18
Last page
If you have any questions relating to your Betaseron® medication, please contact the manufacturer or
refer to the information leaflet provided with the medication.
Please contact our local representative or your MS nurse / healthcare professional, if you have any questions on
the BETACONNECTTM if you do not need it anymore, if you want to dispose of it or in case of malfunctions.
We reserve the right to modify technical specifications and the documentation.
Manufactured by
Bang & Olufsen Medicom a/s
Gimsinglundvej 20
DK-7600 Struer
Denmark
+45 70 301 600
Model BETACONNECT
TM
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