Merck RebiSmart 3.0 Instructions For Use Manual
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Merck RebiSmart 3.0 Instructions For Use Manual

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Instructions for Use
Model: 3.0
RebiSmart® autoinjector delivers a
pre-set dose of Rebif®.
Classification:
Internal
Infotable_CHD_V01
ARTWORK INFORMATION
REF:
MDT-1016_2023_03-EN-INT-V01
TYPE OF COMPONENT:
IFU_IFU
PRODUCT:
REBISMART E. INJECTOR
VARIANT
3.0
STRENGTH
N/A
PACK SIZE
1
MARKET / LANGUAGE:
EN
TECHNICAL DRAWING:
MD_IFU_210x148_V01
ARTWORK DIMENSIONS:
210x148 mm
COLOURS:
TECHNICAL INFO:
CMYK
TRACEABILITY
Version
Date
Designer
01
27.03.2023
Véronique Savia
02
29.03.2023
Véronique Savia
03

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Summary of Contents for Merck RebiSmart 3.0

  • Page 1 Instructions for Use Model: 3.0 RebiSmart® autoinjector delivers a pre-set dose of Rebif®. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS: 210x148 mm COLOURS: TECHNICAL INFO:...

  • Page 2: Table Of Contents

    Contents Introduction to RebiSmart®.............6 Section 1.1 About the device ......................8 Section 1.2 Indications and contraindications ................9 Section 1.3 Safety precautions ....................... 10 Section 1.4 Device and supplies ..................... 12 Getting started ..................20 Section 2.1 Charging the device ..................... 22 Section 2.2 Enter device settings ....................
  • Page 3 Injecting medication with RebiSmart®........30 Section 3.1 Prepare for injection ....................32 Section 3.2 Attach needle ........................ 36 Section 3.3 Administer the injection ..................... 38 Section 3.4 Detach needle and confirm injection ..............40 Caring for the device.................42 Section 4.1 Storing device and cartridges ................... 44 Section 4.2 Taking care of your device ..................
  • Page 4 Settings....................52 Section 5.1 Menu overview ......................54 Section 5.2 History ..........................55 Section 5.3 Injection settings ......................57 Section 5.4 Device settings ......................62 Section 5.5 Battery status ........................ 68 Troubleshooting..................70 Section 6.1 Interrupted injection ....................72 Section 6.2 Dropped device ......................74 Section 6.3 Warning and information messages ..............
  • Page 5 Additional information for doctors or nurses......94 Section 7.1 Complete first time setup wizard ................96 Section 7.2 Clinical setup ......................... 100 Technical specifications and appendix.........104 Section 8.1 Technical data ....................... 106 Section 8.2 Explanation of symbols ....................108 Section 8.3 Electromagnetic specifications ................111 Classification: Internal Infotable_CHD_V01...

  • Page 6: Introduction To Rebismart

    Section 1 Introduction to RebiSmart® This section introduces you to 1.1 About the device RebiSmart® and provides important 1.2 Indications and contraindications 9 safety information about using 1.3 Safety precautions RebiSmart® to deliver Rebif® medication. 1.4 Device and supplies Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION...
  • Page 7 Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS: 210x148 mm COLOURS: TECHNICAL INFO: CMYK TRACEABILITY Version Date Designer 27.03.2023 Véronique Savia 29.03.2023 Véronique Savia...

  • Page 8: Section 1.1 About The Device

    Section 1.1 About the device RebiSmart® is an electromechanical • RebiSmart® will not store or transfer any autoinjector which delivers a pre-set dose of personal information. Rebif® (interferon beta-1a for injection). • If you have any questions, talk to your •...

  • Page 9: Section 1.2 Indications And Contraindications

    Section 1.2 Indications and contraindications Indications for use: Contraindications for use: RebiSmart® is a reusable, electromechanical You should not use RebiSmart® if you software-controlled autoinjector intended for have severe dexterity, visual, upper subcutaneous (under the skin) injection of extremity or cognitive neurological Rebif®...

  • Page 10: Section 1.3 Safety Precautions

    Section 1.3 Safety precautions This section provides general precautions related to using RebiSmart®. Additional warnings and cautions related to specific instructions are highlighted throughout this booklet. If you have any questions after reading this section, do not hesitate to ask your doctor or nurse. Before you proceed, review these general warning and cautions.
  • Page 11 General warning and cautions (continued) • DO NOT change the injection settings on • To avoid administration of non-sterile RebiSmart® until you have discussed it medication: DO NOT use a Rebif® cartridge if it with your doctor or nurse. shows any signs of damage, •...

  • Page 12: Section 1.4 Device And Supplies

    Section 1.4 Device and supplies Items provided in device packaging: Instructions for Use Model: 3.0 RebiSmart® autoinjector delivers a pre-set dose of Rebif®. 1 RebiSmart® 1 Battery 1 Battery charger* 1 Storage box Instructions for Use** autoinjector NOTE: Contact your doctor or nurse for information on the supply of medication cartridges and needles, or if you need replacements for RebiSmart®...
  • Page 13 Other supplies needed: The following pages include details about each of the main components: • RebiSmart® autoinjector delivers Rebif® medication Alcohol wipes Rebif® cartridges • Rebif® cartridge containing Rebif® medication Serofine® needles (29G) • Serofine® needle Biohazard (sharps) (29G) for every container injection Not all cartridges, needles, or supplies are...
  • Page 14 Section 1.4 Device and supplies (continued) RebiSmart® autoinjector RebiSmart® is an electromechanical device that automatically injects the set dose of medication through single-use needles it inserts and retracts on each injection. • The skin sensors around the needle cavity detect if the device is positioned correctly onto your skin.
  • Page 15 Side views Battery On/Off button latch USB-C Cartridge port door latch Status light Battery Cartridge door Needle Skin cavity sensor Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS:...
  • Page 16 Section 1.4 Device and supplies (continued) Touch screen Press buttons Swipe The touch screen provides current information, settings, and scroll instructions on how to administer an injection. You can press buttons, or swipe up and down on lists to navigate the screens and make selections.
  • Page 17 Rebif® cartridges There are two Rebif® cartridge types compatible with RebiSmart®: 132 µg (44 µg/0.5 mL) • 132 µg (microgram, mcg), i.e., 3 doses of 44 µg (concentration: 44 µg/0.5 mL) • 66 µg, i.e., 3 doses of 22 µg (concentration: 22 µg/0.5 mL) Carefully check the Rebif®...
  • Page 18 Section 1.4 Device and supplies (continued) Sterility Serofine® needles seal There is one Serofine® needle type Needle compatible with RebiSmart®: ® Serofine needle • 29G × 1/2” Needle (thickness: 0.33 mm × length: 12 mm ) 12 mm Carefully check the size (or gauge “G”) on the needle carton and the sterility seal of each individual needle to ensure if you 29G needle...
  • Page 19 Discard supplies and device If you no longer use RebiSmart®, dispose of Use a sharps container to dispose of used it in accordance with your local regulation. needles after each injection and to dispose of Contact your doctor or nurse for more used cartridges.

  • Page 20: Getting Started

    Section 2 Getting started This section provides instructions 2.1 Charging the device for setting up the device before 2.2 Enter device settings administering a first injection. 2.3 Inserting cartridge Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E.
  • Page 21 Reminders and tips for getting started with RebiSmart® • You must receive appropriate training from your doctor or nurse before changing any settings and before using RebiSmart®. • Some device settings can only be changed by a doctor or nurse. If device set up is not complete, the on-screen injection button will remain disabled.

  • Page 22: Section 2.1 Charging The Device

    Section 2.1 Charging the device NOTE: There are two ways to charge Confirm the battery is fully charged ( the battery: before using the device for the first time. Charge the battery If the battery is not fully charged, use the while it is in the battery charger supplied with the device.
  • Page 23 Connect battery Insert battery Confirm battery is to power source into device fully charged Insert, Green steady slide up light • Plug the battery charger’s Insert and slide battery • Check the status light. USB-C plug into the If light is steady green, back up until it clicks in battery port.

  • Page 24: Section 2.2 Enter Device Settings

    Section 2.2 Enter device settings RebiSmart® contains Set language Turn on device device and injection settings that will need to be set up before you can use the device. These Scroll settings can be changed later on as well. • Swipe up or down and Press and hold on/off button until the display press checkbox to select...
  • Page 25 Set date and Set date Set time time format Scroll • Press checkbox to select • Swipe down or up to • Swipe down or up across select current time the date and time screen to go the right format you prefer. month and select current •...
  • Page 26 Section 2.2 Enter device settings (continued) Your doctor or nurse must enter clinical settings Your doctor or nurse must enter the clinical settings that control your dosing and treatment delivery. The on-screen injection button will remain disabled until the set-up is completed. If your doctor or nurse is not with you to do it, press “No”...

  • Page 27: Section 2.3 Inserting Cartridge

    Section 2.3 Inserting cartridge Before injecting medication (as Get a new cartridge and inspect instructed in Section 3), you must first insert a new Rebif® Medication cartridge. When handling the MM-DD-YYYY Septum cartridge, handle with care. Check that the: • Packaging and cartridge label have the medication and NOTE dosage of Rebif®...
  • Page 28 Section 2.3 Inserting cartridge (continued) Open cartridge Unlock cartridge door door To unlock the cartridge door: Slide cartridge door latch up to open door. a. Open menu. NOTE: If device contains a cartridge b. Select injection settings. that is not empty, you will need to unlock c.
  • Page 29 Insert cartridge Close cartridge door Insert cartridge into cartridge holder with Push cartridge door to close it. metal tip pointing down. NOTE: RebiSmart® may take up to 20 seconds to recognize the cartridge and go back into the menu. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION...

  • Page 30: Injecting Medication With Rebismart

    Section 3 Injecting medication with RebiSmart® This section is a step-by-step 3.1 Prepare for injection guide for injecting medication 3.2 Attach needle with RebiSmart®. 3.3 Administer the injection 3.4 Detach needle and confirm injection Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU...
  • Page 31 Reminders and tips for injecting with RebiSmart® CAUTION • DO NOT use RebiSmart® if it is not working properly. • DO NOT attempt to modify, or repair the device, or an incorrect dose might be delivered. Contact your doctor or nurse in case of device malfunction. •...

  • Page 32: Section 3.1 Prepare For Injection

    Section 3.1 Prepare for injection Gather supplies NOTE If an injection plan is set up, a notice appears to tell you if it is the right time to inject (RebiSmart® will not provide a sound or LED reminder). Depending on which dose mode is Place all items listed below on a active, RebiSmart®...
  • Page 33 Check device Wash hands Prepare injection site Before each injection, check Wash your hands well with Select and prepare your the device. Make sure the soap and water and dry injection site. Injection site cartridge and medication them with a clean towel. should be based on the correspond to the Rebif®...
  • Page 34 Section 3.1 Prepare for injection (continued) Press injection Turn on device Press and hold on/off button until the Press on-screen injection button display switches on. to start the injection process. RebiSmart® will guide you step-by- After a few seconds the home screen will step to administer an injection.
  • Page 35 NOTE: If you have set up the rotation guide feature, RebiSmart® will display the possible injection sites for your injection after pressing on-screen injection button (refer to “Section 5.3 Injection settings” to set up the rotation guide). Select an injection site: Green circle means you can Select an injection site Press...

  • Page 36: Section 3.2 Attach Needle

    Section 3.2 Attach needle Get a new needle Remove seal Needle size • Get a new Serofine® needle. Pull flap and fully remove sterility seal. • Check that needle size (gauge “G”) on the needle cap’s sterility seal is the same as the needle size on RebiSmart®...
  • Page 37 Insert needle, let go Remove cap Needle Keep fingers cavity away When RebiSmart® screen tells you “Insert When RebiSmart® screen tells to, push the new needle”: needle cap sideways to remove it. • Push needle cap with needle straight DO NOT inspect the needle cavity when the into the needle cavity until it clicks.

  • Page 38: Section 3.3 Administer The Injection

    Section 3.3 Administer the injection Hold device against skin NOTE: If you DO NOT inject right away Chime sound, RebiSmart® will give you White ready light instructions to: • After 60 seconds - continue or cancel injection • After 10 minutes - insert an empty needle cap to unload the expired needle.
  • Page 39 Inject medication Remove RebiSmart® Chime sound, White ready light a. Press injection button once to begin a. When the injection is complete, injecting. The injection button light RebiSmart® plays a chime sound and flashes white during the injection. the injection button light will stop flashing and turn off.

  • Page 40: Section 3.4 Detach Needle And Confirm Injection

    Section 3.4 Detach needle and confirm injection Insert needle cap, let go Remove needle Needle Keep fingers cavity away When RebiSmart® screen tells you “Insert needle cap”: When RebiSmart® screen tells to, push the needle cap • Push empty needle cap straight into the needle cavity sideways to remove it.
  • Page 41 Dispose needle Confirm Power off and injection store device Dispose of cap with needle in a. Review the amount of a. Press and hold the on/off a sharps container. doses left and battery button until the display charge on the screen. switches off.

  • Page 42: Caring For The Device

    Section 4 Caring for the device This section gives you instructions 4.1 Storing device and cartridges on how to take care of RebiSmart® 4.2 Taking care of your device when traveling, storing, replacing 4.3 Changing cartridge RebiSmart®, or changing a cartridge. 4.4 Replacing device 4.5 Travel with device Classification:...
  • Page 43 Reminders and tips to care for your RebiSmart® CAUTION: DO NOT attempt to modify, or repair it, or an incorrect dose might be delivered. Contact your doctor or nurse in case of device malfunction. • Only use Rebif® cartridges with RebiSmart® that are stated in your prescription.

  • Page 44: Section 4.1 Storing Device And Cartridges

    Section 4.1 Storing device and cartridges General storage instructions No needle • Keep the unused Rebif® • Discard each cartridge • Before storing RebiSmart®, within 28 days after first cartridges and Serofine® make sure there is no needle injection to avoid expired needles in their original in the device.

  • Page 45: Section 4.2 Taking Care Of Your Device

    Section 4.2 Taking care of your device To wipe the device If the device is dirty and you would like to wipe it, perform the following steps on the right. If RebiSmart® has been exposed to liquid, wipe it with a clean, dry cloth, then check for error messages (see section 6).

  • Page 46: Section 4.3 Changing Cartridge

    Section 4.3 Changing cartridge Only change the cartridge inside RebiSmart® if: RebiSmart® displays the cartridge status in the top right corner: • You did not store the Rebif® cartridges according to the Patient Information Leaflet. • RebiSmart® displays “Cartridge expired” because the cartridge is expired (28 days after first use).
  • Page 47 Get a new cartridge and inspect Unlock cartridge door Medication MM-DD-YYYY Septum Check that the: • Packaging and cartridge label have the medication and dosage of Rebif® (132 or 66 µg). • Cartridge’s expiration date has not passed. To unlock the cartridge door: •...
  • Page 48 Section 4.3 Changing cartridge (continued) Open cartridge door Remove cartridge No needle • Make sure there is no needle inside. If Remove cartridge from cartridge holder. there is see section 3.4 for instructions to detach needle. WARNING: • Slide cartridge door button up to open DO NOT use RebiSmart®...
  • Page 49 Discard cartridge Insert new Close cartridge cartridge door Discard the empty, expired Insert new cartridge into Push cartridge door to close it. or broken cartridge in a cartridge holder with metal sharps container. tip pointing down. NOTE: RebiSmart® may take up to 20 seconds to recognize the cartridge and go back into the menu.

  • Page 50: Section 4.4 Replacing Device

    Section 4.4 Replacing device The expiration date is printed on the device label. The device does not require any special maintenance. Starting 6 months before the expiration date, RebiSmart® will regularly present messages to remind you of the expiration date. Contact your doctor or nurse when it is time to replace your RebiSmart®.

  • Page 51: Section 4.5 Travel With Device

    Section 4.5 Travel with device You are allowed to travel with the device. If you are going to travel with RebiSmart®, remember: • Travel with the device in your carry-on luggage. DO NOT travel with the device in your check-in luggage. It is recommended to store RebiSmart® in the storage box when traveling.

  • Page 52: Settings

    Section 5 Settings This section instructs you on how to 5.1 Menu overview change RebiSmart® settings. 5.2 History 5.3 Injection settings 5.4 Device settings 5.5 Battery status Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE...
  • Page 53 Reminders and tips to change RebiSmart® settings CAUTION: DO NOT change the injection settings on RebiSmart® until you have discussed it with your doctor or nurse. • Clinical setup features can only be changed by your doctor or nurse. Contact your doctor or nurse if you want to change any of these items.

  • Page 54: Section 5.1 Menu Overview

    Section 5.1 Menu overview Each section provides access to a number of feature and Press the button on the settings. home screen to access the main menu. You can press the Injection settings button to return to the History home screen. •...

  • Page 55: Section 5.2 History

    Section 5.2 History Use the history menu to review your total Clinical summary number of injections including the time, date, dose injected and number of times you have changed the cartridge. There are four ways to view your injection history: Calendar, List, Clinical summary, and Injection site.
  • Page 56 Section 5.2 History (continued) Calendar view Injection List view Injection site Swipe scroll Calendar view shows your List view shows a Injection site shows your daily injections one month at chronological list of events. injection site history over a time. For details on injection multiple months.

  • Page 57: Section 5.3 Injection Settings

    Section 5.3 Injection settings You can control some aspects of your Rebif® Sites and depth injection with RebiSmart® by adjusting the injection settings. NOTE: Contact your doctor or nurse for advice on adjusting these settings. To access the Injection settings menu: a.
  • Page 58 Section 5.3 Injection settings (continued) Scroll By default, all injection sites a. Select the appropriate Press to continue are selected and have an depth for the injection to rotation guide setup. injection depth of 10 mm. site or select OFF if you do not want that site You can switch between to be used.
  • Page 59 Speed Hold time Scroll Speed is rate at which medication is The time the needle remains in the skin delivered during the injection. It can be set after medication has been delivered. to one of three values: Slow, Medium and The needle will retract after this time Fast.
  • Page 60 Section 5.3 Injection settings (continued) Remove/Insert cartridge Injection plan Unlock cartridge door to remove the Set up a schedule on which days and times cartridge: you will inject. After setting up this injection plan, RebiSmart® will display the time until a.
  • Page 61 d. Select three days on which you will f. Select the time for the injections. inject. g. Press to continue. e. Press to continue. NOTE: Selecting consecutive days is not allowed. A minimum of 48 hours is recommended between each injection. Classification: Internal Infotable_CHD_V01...

  • Page 62: Section 5.4 Device Settings

    Section 5.4 Device settings Use the Device settings screen to adjust the settings of the device, such as color use, volume, language, date and time, and connectivity. To access the Device settings menu: a. Open menu from the home screen. b.
  • Page 63 Data transfer To automatically transfer To manually transfer You can set RebiSmart® to transmit your injection history device related information device related information after each injection: (e.g., on demand): to a mobile application accessible by you. a. Select data transfer. a.
  • Page 64 Section 5.4 Device settings (continued) Personalize High contrast Color themes “Personalize” provides two ways to modify the way To turn on high contrast, press To change the colors of the screens look. button to ON. screens: Select Personalize to a. Press “Color themes”. access options.
  • Page 65 Volume Language Scroll The default sound setting is “High”, to The language is set during the device set change: up the first time you turn on RebiSmart®. To change: • Select Volume. • Select Language. • Select the volume you prefer, or “Mute” to turn sounds off.
  • Page 66 Section 5.4 Device settings (continued) Date / Time When you select “Set date”: a. Scroll up or down and press to select the current date. b. On the next screen, press confirm. When you select “Set time”: a. Scroll up or down to select the current time.
  • Page 67 System info Scroll “System info” displays compliance to local regulations. See Section 8.2 for the symbols chart. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS: 210x148 mm...

  • Page 68: Section 5.5 Battery Status

    Section 5.5 Battery status Battery status You can check the battery level of the device at any Battery status icons time. The battery status is displayed on the right side at the top of the home screen. A fully-charged battery can power the device for about 30 days.
  • Page 69 THIS PAGE INTENTIONALLY LEFT BLANK. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS: 210x148 mm COLOURS: TECHNICAL INFO: CMYK TRACEABILITY Version Date Designer 27.03.2023...

  • Page 70: Troubleshooting

    Section 6 Troubleshooting This section provides an overview of 6.1 Interrupted injection warning and information messages 6.2 Dropped device that may be displayed on RebiSmart®, 6.3 Warning and frequently asked questions, and what information messages to do if you have dropped the device, 6.4 Frequently asked questions or interrupted an injection.
  • Page 71 Reminders and tips when troubleshooting your RebiSmart® CAUTION • DO NOT use RebiSmart® if it is not working properly. • DO NOT modify or attempt to repair RebiSmart®, to avoid risk of incorrect dosing. • If you have any questions or concerns, or if the steps provided in this section do not correct the issue, contact your doctor or nurse.

  • Page 72: Section 6.1 Interrupted Injection

    Section 6.1 Interrupted injection Red interruption light If RebiSmart® is lifted off of your skin during an injection, RebiSmart® will stop the medication flow and retract the needle. This is called an “interrupted injection” and means you did not receive your complete dose. •...
  • Page 73 Injection has been interrupted, inject remaining dose Partial dose message Injection interrupted warning • Press to attach a new • Press to detach the used needle and to complete the partial needle and to complete the partial dose injection. dose injection. NOTE: Keep RebiSmart®...

  • Page 74: Section 6.2 Dropped Device

    Section 6.2 Dropped device Check needle: RebiSmart® should be handled with care. Take care not to drop RebiSmart®. First, if the needle is bent or exposed, you If you have dropped the device, you need to may use small pliers to carefully remove the check the needle, cartridge and device for needle and discard it safely.
  • Page 75 b. Contact your doctor or nurse to replace the device. If the cartridge is not broken inside the device: c. Turn on device. The drop might have caused a device failure. d. If device functions normally, unlock cartridge door: • Open menu.

  • Page 76: Section 6.3 Warning And Information Messages

    Section 6.3 Warning and information messages Warning and Information message screens tell you if an error or issue is detected, and what you should do about it. The table in this section lists the main message screens for your reference, in addition to the instructions provided on the screen. RebiSmart®...
  • Page 77 Type Screen title What happened and what to do Battery removed The battery has been removed while using the device. This action may cause harm to the device. during operation Cartridge cannot Cartridge cannot be used with device. Go to injection settings to remove and discard the cartridge.
  • Page 78 Section 6.3 Warning and information messages (continued) Cartridge status Device is not able to determine the cartridge’s status. If cartridge is not new, make sure the cartridge is within 28 is unknown days after first injection. Or, if the cartridge has been in use for 28 days, it is expired, do not inject, replace the cartridge.
  • Page 79 Check settings Device turned off while modifying settings. To confirm settings, contact your doctor or nurse. Clinical setup Clinical setup can only be changed by your doctor or nurse. Contact your doctor or nurse if you would like to make any changes to the clinical setup of your device.
  • Page 80 Section 6.3 Warning and information messages (continued) Device error The device encountered an error. Turn the device off and then on again. After you turn on the device, select Menu > Injection settings > Remove/Insert cartridge>, then take out the cartridge and insert back the cartridge to let the device recognize the cartridge.
  • Page 81 Injection Injection procedure was interrupted. This occurs when the device leaves the skin during an injection. You did not interrupted receive your complete dose. The device will lead you through the steps to remove the needle. Last injection The last injection was less than 48 hours ago. A 48 hour period between injections is recommended.
  • Page 82 Section 6.3 Warning and information messages (continued) Needle Check the on-screen instructions, and these two options: attachment • You inserted an empty needle cap. Remove this needle failure cap and insert a new needle cap with a needle inside. • Device is not able to detect and retract the needle. Carefully remove the needle cap and check if the needle is inside.
  • Page 83 Needle You inserted a needle cap that was not empty. Discard this needle cap and insert an empty needle cap to remove needle. detachment failure Needle expired Needle has been exposed to air for more than 10 minutes, which compromises needle sterility. The device will lead you due to inactivity through the steps to remove the needle.

  • Page 84: Section 6.4 Frequently Asked Questions

    Section 6.4 Frequently asked questions Using RebiSmart® What if I cannot turn my RebiSmart® on? Make sure that when you turn on RebiSmart®, you hold down the selection button on the right (power on) until the home screen appears. Make sure that the battery is charged and properly connected.
  • Page 85 What if I remove RebiSmart® from my skin during an injection? If you remove RebiSmart® from your skin during an injection (while the injection button light is flashing white), the injection will stop, the needle will retract and RebiSmart® will display a warning message: •...
  • Page 86 Section 6.4 Frequently asked questions (continued) What if I notice a drop of Rebif® on my skin after the injection? If you notice a drop of Rebif® on your skin when you remove RebiSmart®, you may need to: • Reduce the injection speed, and/or •...
  • Page 87 What if I cannot insert a new needle or needle cap into my RebiSmart®? If you cannot insert the needle cap, check if there is any foreign object in the needle cavity. If there is foreign object in the needle cavity: a.
  • Page 88 Section 6.4 Frequently asked questions (continued) Settings What should I do when my doctor prescribes a new dose? Consult your doctor or nurse to update your dose setting in RebiSmart®. Once your new prescribed dose is entered, RebiSmart® will automatically detect the cartridge type and adjust accordingly. You may need to insert a cartridge with different concentration: go to injection settings to remove cartridge, consult your doctor or nurse to update the dose in clinical setup, finally go to injection settings to insert new cartridge.
  • Page 89 Connectivity How is my device data processed? How do I share my injection history? Sharing any log data firstly requires you to activate the data transfer functionality in your device. If activated, your device can send anonymous device logs and information, injection and technical data, error reports, and generally information that helps us understand how our devices are being used or to identify potential improvements.
  • Page 90 Section 6.4 Frequently asked questions (continued) Storage and maintenance How should I store the cartridge? You should refer to the Rebif® Patient Information Leaflet. Should I remove the battery if I keep RebiSmart® in the refrigerator? There is no need to remove the battery if you keep RebiSmart® in the refrigerator. However, if you want to charge the battery, you should remove the battery to charge it outside of the refrigerator.
  • Page 91 device for about 30 days. If you need to frequently charge the battery, the battery may be degraded. Please contact your doctor or nurse for a new battery. What if the battery status light flashes red when charging the device? When the status light of the battery flashes red it is not recharging.
  • Page 92 Section 6.4 Frequently asked questions (continued) Travel How do I store my device while traveling? You can travel with RebiSmart®. It is recommended to store RebiSmart® in the storage box when traveling. The device is safe to pass through X-ray airport security gates with the Rebif® medication inserted.
  • Page 93 THIS PAGE INTENTIONALLY LEFT BLANK. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS: 210x148 mm COLOURS: TECHNICAL INFO: CMYK TRACEABILITY Version Date Designer 27.03.2023...

  • Page 94: Additional Information For Doctors Or Nurses

    Section 7 Additional information for doctors or nurses This section is for doctor or nurse only 7.1 Complete first time setup wizard 96 and describes how to setup RebiSmart® 7.2 Clinical setup for first time use, enter clinical settings, and train people to use RebiSmart®. Classification: Internal Infotable_CHD_V01...
  • Page 95 CAUTION • This section is for doctors and nurses only. As a patient you should not use these instructions. • Contact your doctor or nurse if you would like to receive information about this section. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT:...

  • Page 96: Section 7.1 Complete First Time Setup Wizard

    Section 7.1 Complete first time setup wizard As a doctor or nurse you will need to Confirm you are a complete the Clinical setup portion of the nurse or doctor first time setup wizard. These are settings following the basic device settings in “Section 2.2 Enter device settings”.
  • Page 97 Create PIN Set dose Set titration • Press checkbox of the • Type in a 4-digit PIN • Press button prescribed dose. code if you want to to ON to switch on lock access to the titration. • Press arrow to clinical settings.
  • Page 98 Section 7.1 Complete first time setup wizard (continued) Device data Confirm settings Complete transfer • Press “Yes” checkbox • Review the clinical • Press to complete to turn data transfer settings. the device setup. on. Or, press “No”. • Press to confirm, or •...
  • Page 99 NOTE You can demonstrate the injection process without injecting by inserting a demo cartridge. This will prompt the device to enter demonstration mode. Demo injections can only be done using a demo cartridge. Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT:...

  • Page 100: Section 7.2 Clinical Setup

    Section 7.2 Clinical setup Use the clinical setup screens to adjust the treatment settings, such as dose and titration. In the clinical setup you can also change or turn the PIN code on/off. To access the Clinical setup menu: NOTE: Before you insert a cartridge a.
  • Page 101 After making an adjustment, select to confirm each new setting. Note that titration and dose reduction cannot be turned ON at the same time. Dose Titration The dose defines how much medication is Titration is the gradual increase of administered during an injection. Press to medication over time.
  • Page 102 Section 7.2 Clinical setup (continued) Dose Dose reduction Press button to ON When Dose reduction is turned ON, The dose defines how much medication RebiSmart® will administer a 50% dose is administered during an injection. of Rebif® up to 36 times. Dose reduction •...
  • Page 103 Titration PIN code The titration period lasts 4 weeks and during this time 12 injections will be administered using RebiSmart®. The first six injections will deliver 20% of the selected dose (e.g. 8.8μg for a dose set to 44μg) and the next six will be 50% of the selected dose (e.g.

  • Page 104: Technical Specifications And Appendix

    Section 8 Technical specifications and appendix This section provides an overview of 8.1 Technical data RebiSmart®’s technical specifications. 8.2 Explanation of symbols 8.3 Electromagnetic specifications Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE...
  • Page 105 Classification: Internal Infotable_CHD_V01 ARTWORK INFORMATION REF: MDT-1016_2023_03-EN-INT-V01 TYPE OF COMPONENT: IFU_IFU PRODUCT: REBISMART E. INJECTOR VARIANT STRENGTH PACK SIZE MARKET / LANGUAGE: TECHNICAL DRAWING: MD_IFU_210x148_V01 ARTWORK DIMENSIONS: 210x148 mm COLOURS: TECHNICAL INFO: CMYK TRACEABILITY Version Date Designer 27.03.2023 Véronique Savia 29.03.2023 Véronique Savia...

  • Page 106: Section 8.1 Technical Data

    Medical device classification MDR 2017/745/EU Class IIa Device’s life time 5 years from manufacturing date, refer to device’s labelling Cartridge Merck Rebif® (interferon beta-1a) Maximum injection volume 0.8 mL (in the event of a device failure) Dose accuracy +/- 15% Needles Serofine®...
  • Page 107 LTE B2, B3, B4, B5, B8, B12, B13, B20, B26, B28 Operating frequency bands GSM 850 MHz, E-GSM 900 MHz, DCS 1800 MHz, PCS 1900 MHz Maximum radio-frequency power LTE category M1 / NB1: Class 3 (23 dBm) transmitted in the operating frequency 2G GMSK: Class 4 (33 dBm) in 850/900, Class 1 (30 dBm) in 1800/1900 bands 2G 8-PSK: Class E2 (27 dBm) in 850/900, Class E2 (26 dBm) in 1800/1900...

  • Page 108: Section 8.2 Explanation Of Symbols

    Section 8.2 Explanation of symbols The following symbols appear on the RebiSmart® labelling. Reference numbers refer to symbols in standard ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. Direct current.
  • Page 109 Section 8.2 Explanation of symbols (continued) Authorized representative in the Serial Number. Indicates the manufacturer’s European Community. Indicates the Authorized serial number so that a specific medical device representative in the European Community. Reference can be identified. Reference number 5.1.7. number 5.1.2.
  • Page 110 Section 8.2 Explanation of symbols (continued) Marking showing compliance to local regulations Paraguay - CONATEL Argentina - Ramatel UAE - TDRA mark mark mark UK - UKCA mark Australia - RCM mark Serbia - 3A mark Mexico - IFT mark Taiwan - NCC mark See “Section 5.4 Device settings”.

  • Page 111: Section 8.3 Electromagnetic Specifications

    Section 8.3 Electromagnetic specifications RebiSmart® is intended for use in a Home Healthcare environment having the characteristics specified below. User shall ensure that RebiSmart® is used under the following conditions in order to maintain its essential performances. Should RebiSmart® be operated outside of the specified conditions, the device might stop working.
  • Page 112 Section 8.3 Electromagnetic specifications (continued) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
  • Page 113 Electromagnetic Immunity Immunity test EMC standard Compliance level ± 8 kV contact Electrostatic discharge IEC 61000-4-2 ± 2 kV, ± 4 kV, ± 8 kV air ± 15 kV air 10 V/m Radiated RF EM fields IEC 61000-4-3 80 MHz to 2.7 GHz 80% AM at 1kHz Proximity fields from RF wireless communications IEC 61000-4-3...
  • Page 114 Section 8.3 Electromagnetic specifications (continued) Immunity to proximity fields from RF wireless communications equipment Test Max power Distance Immunity Test Frequency Band (MHz) Service Modulation* Level (V/m) (MHz) Pulse modulation 380-390 TETRA 400 18 Kz FM, ± 5kHz deviation, 430-470 GMRS 460, FRS 460 1 kHz sine 710, 745,...
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  • Page 116 These instructions for use are also Ares Trading SA available electronically at Zone industrielle de l’Ouriettaz www.arestradingdevices.com 1170 Aubonne Switzerland RebiSmart, Rebif, Serofine are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. 2797 (2023) 0086 Revision date: March 2023 MDT-1016_2023_03-EN-INT-V01 20641979...

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