BETACONNECTTM Instructions for use Language: English Version: 2013-10 1 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 2 Important notes Warning!
Whenever you see this symbol it means that safety instructions must be followed. Please read these instructions prior to using BETACONNECTTM 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 BETACONNECTTM must never be pointed at another person or yourself except in order to inject Betaseron The BETACONNECTTM is not intended for use on more than one patient (danger of infection). The BETACONNECTTM cannot be sterilized. The BETACONNECTTM 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 BETACONNECTTM 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 BETACONNECTTM 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 BETACONNECTTM 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 BETACONNECTTM 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. 3 Chapter 1: First Time Use 1.1. First time use of BETACONNECTTM 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. Important: Fully charge the BETACONNECTTM (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. 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. 4 Chapter 2: Things you should know about the BETACONNECTTM 2.1. Overview Injection button On/off button Light bar Injection speed setting Reminder on/off Safety release Blue lid release button Needle depth setting 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 Phase II Phase III Phase IV Inserting the needle - the syringe is pushed forward so that the needle penetrates the skin. Injecting the medication - the medication is injected subcutaneously (injection speed depends on injection speed setting). Dwell time - the needle briefly remains in the skin to allow the medication to be spread in the subcutaneous skin tissue. 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 5 BETACONNECTTM is designed to injection volumes between 0.25 to 1.0 ml. 2.3. Charging the BETACONNECTTM Important: The BETACONNECTTM cannot be used for injection while charging. The BETACONNECTTM can be recharged at a temperature from 10C to 35C / 50 95F. 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. 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 Step 2: Charging the BETACONNECTTM and verify charging status 2.4. Care, storage and disposal Your BETACONNECTTM can be stored at a temperature from 10 to 40C (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 40C (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 BETACONNECTTM is exposed to extreme vibrations, pressure or shock (e.g. dropping or stepping on it) there is a risk of damaging the BETACONNECT TM. 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. 6 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. 7 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. BETACONNECTTM conducts a self-test each time the BETACONNECTTM is turned on. Turn 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. Step 3: Open the lid Step 4: Insert Syringe Press to open lid 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. Fully open the lid by pressing the blue lid release button on the side of the BETACONNECTTM. 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. 8 For depth and speed setting please read chapter 4
(Adjustments). 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 BETACONNECTTM is now ready to be used for an injection. The lid must be fully closed to administer an injection. Clean the chosen injection area with an alcohol swab. Remove the needle cap by pulling it off at the front of the BETACONNECTTM. Do not twist when removing the needle cap. Important: Be careful not to accidentally press the injection button while removing the needle cap from the BETACONNECTTM. Gently hold the BETACONNECTTM 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 BETACONNECTTM against your skin for the entire injection. Important: Make sure not to accidentally touch the front of the BETACONNECTTM when there is a syringe in it because you may accidentally start the injection by pressing the injection button. 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 3.2. Injection procedure Step 6: Clean the injection site Step 7: Remove needle cap Step 8: Place the BETACONNECTTM against the injection site Step 9: Start the Injection 9 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. 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 injection. Step 9: Completeness of Injection 3.3. Removing the used syringe and needle Step 10: Open the lid Push to open lid Do not remove the BETACONNECTTM 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. Fully open the lid by pressing the blue lid release button on the side of the BETACONNECTTM. 10 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. 11 Chapter 4: Adjustments 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. 4.1. Adjusting the injection depth Step 1: Open the lid fully Insertion depth slider Step 2: Set the depth slider to the desired setting 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. 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. 4.2. Adjusting the injection speed 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. Adjustment:
Fast: Move slider below Medium: Move slider below Slow: Move slider below symbol. symbol. symbol. Injection speed slider Step 2: Set the injection speed slider to the desired setting 12 4.3. Setting the reminder function Step 1: Open the lid fully Reminder enabled If the reminder function is activated, the BETACONNECTTM 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:
Step 3: Reminder feature
: Reminder function enabled
: Reminder function disabled 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. Reminder signal To cancel both the beep and flashing light reminder, press the on/off button. 13 Chapter 5: Trouble shooting If assistance is needed during setting up, using, or maintaining the BETACONNECTTM contact your MS nurse /
healthcare professional. Problem Cause Solution It is not possible to turn on the BETACONNECTTM 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 /
BETACONNECTTM turns automatically off. 1. BETACONNECTTM will automatically turn off after 20 minutes of inactivity. 2. BETACONNECTTM will power off if the battery level is too low. It is not possible to use the BETACONNECTTM while being charged 1. The BETACONNECTTM will not operate when it is being charged. healthcare professional for a replacement. 1. Press the on-/off-button to turn on. 2. Recharge the BETACONNECTTM if the battery indicator is flashing orange when you turn on the BETACONNECTTM. 3. Charge the BETACONNECTTM and remove charger before use. It is not possible to open the lid 1. The lid cannot be opened 1. Wait until the injection process is during the injection process. completed. It is not possible to inject by activating the safety release 2. The lid or the opening button 2. Please contact your MS nurse /
does not function. healthcare professional for a replacement. 1. The safety release does not 1. Please contact your MS nurse /
function. healthcare professional for a replacement. It is not possible to charge the BETACONNECTTM 1. The wrong USB cable or 1. Make sure that the charger and charger is used. cables provided with the BETACONNECTTM are used. 2. The USB connection is worn 2. Please contact your MS nurse /
out. It is not possible to insert the syringe into the BETACONNECTTM 1. The wrong syringe type is used. healthcare professional for a replacement. 1. Only use syringes provided with your Betaseron with the BETACONNECTTM. The green light on the on-/off button does not stop blinking after the BETACONNECTTM was turned on. 2. The syringe is not placed into 2. Make sure that the syringe is the insertion area correctly. lined up with the syringe outline in the insertion area correctly. 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. 14 Problem Cause Solution 4. Hold on-/off button to shut down BETACONNECTTM 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 1. interrupted. 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 BETACONNECTTM 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 1. The BETACONNECTTM can be too high. recharged at a temperature from 10C to 35C / 50 95F. 15 Chapter 6: Technical Specifications 6.1. Labeling On your BETACONNECTTM/packaging the following symbols are used:
It is important that you read this instruction before you use the BETACONNECTTM. 0543 0681 FCC ID: 2AAGY-
BETAC1 16 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. 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 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 40C / 41 - 104 F. The BETACONNECTTM can be stored at a temperature from 10 to 40C / 14 - 104 F. 6.2. Technical Specification Type:
BETACONNECTTM, class IIa medical device in Europe or class II medical device in the USA Life time Serial Number (SN) 3 years after manufacturing date Please refer to the inside of the lid of your BETACONNECTTM Size:
Weight:
165 x 52 x 42 mm (approximately 6.496 x 2.047 x 1.654 Inch) Approx. 185 g / 6.4 oz. Light Display:
Light-emitting diode (LED) Power Supply Electromagnetic Compatibility Radio transmitting 1 rechargeable internal Li-Ion battery. 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 BETACONNECTTM 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. Bluetooth 4.0 using a customized encrypted protocol. hardware Class B digital device Bluetooth and USB communication can only be established using dedicated software, contact your MS nurse / healthcare professional. 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. 17 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 BETACONNECTTM 18