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Enbrel SMARTCLIC APP-1000 - User Manual

Enbrel SMARTCLIC APP-1000
40 pages
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Injection Device
This SMARTCLIC® Injection Device is intended to be used for
self-injection only for Enbrel®
USER MANUAL
RemindersHistory Customise
Battery
Indicator
Bluetooth®
Injection
speed
Scan QR code for
SMARTCLIC App
EN
Before Using Your
SMARTCLIC Injection Device:
Make sure you follow the rst time setup instructions
overleaf. This is to ensure you get the best experience
from your SMARTCLIC Injection Device.
Make sure you have read and understood this User
Manual before using your SMARTCLIC Injection
Device.
Unpack your SMARTCLIC Injection Device box. Make
sure you have all the correct components:
z 1 SMARTCLIC Injection Device
z 1 Training Cartridge
z This User Manual in your preferred language
Note: If you do not have everything you need, ask
your healthcare professional.
Retain this User Manual for future reference.
Printed in Japan
P1120-2101
2021-10-08KER-DR-0173 (L)
APP-1000
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Summary

Before Using Your SMARTCLIC Injection Device

Unpack Your Device Box

Check components: 1 SMARTCLIC Injection Device, 1 Training Cartridge, and this User Manual.

Retain User Manual

Keep this User Manual for future reference.

Your SMARTCLIC Injection Device Overview

Device Top Components

Describes the LCD Display, Injection button, and Up/Down buttons on the device.

Device Bottom Components

Describes the Cartridge door, injection point, and skin sensor.

First Time Setup Procedure

Initiating First Time Setup

Press and hold Injection button to turn on, use menu buttons, and select with Injection button.

Completing Setup Steps

Set Date and Time Format, Correct Date, Correct Time, and Confirm Date and Time.

Chapter 1: Important Information

Intended Purpose of Device

Device is an electrical auto-injector for self-injection of subcutaneous doses of Tumor-Necrosis Factor inhibitors.

Getting Started Guide

Read manual, retain for reference, be over 18, understand device/cartridge terms, use training cartridge.

Important Information: Warnings

Device Warnings

Use only with Enbrel cartridges, do not share, avoid EM fields, check for damage, do not disassemble.

Important Information: Cautions

Device Cautions

Use after training, avoid rough handling, do not insert foreign objects, avoid water and extreme conditions.

Important Information: HCP Guidance

Healthcare Professional Guidance

Ensure patient is over 18, provide training, instruct on reporting abnormalities and proper disposal.

Chapter 2: About Your SMARTCLIC Injection Device

Operating Environment Requirements

Storage and Cleaning Instructions

Cartridge Overview

Dose Dispenser Cartridge Information

Dose Dispenser Cartridge Disposal

Chapter 3: Training to Give an Injection

Training Cartridge Information

Holding Your Device for Injection

Using Your Training Cartridge

Menu Overview and Navigation

Turning Device On to Access Menus

Hold the Injection button to turn on the Device and access menus.

Home Screen Display

Shows notification of last injection status. Use Injection button to go to Top Menu.

Top Menu Navigation

Use Menu buttons to scroll, Injection button to enter, Cancel/Eject to return to Home Screen.

Injection History

Injection History Calendar View

View injection history in a calendar month format with ticks, crosses, and bells.

Injection History Detail View

View injection history in a text format, showing status like Abort, Error, or Training.

Device Settings: Injection Speed

Adjusting Injection Speed

Change injection speed (Fast, Medium, Slow) for comfort. Access only when no cartridge is inserted.

Device Settings: Device Sound

Adjusting Device Sound Volume

Adjust sound volume levels (High, Low, Off). Alarms and tones are emitted even if sound is off.

Device Settings: Display Brightness

Adjusting Display Brightness

Adjust display brightness levels (High, Low) for better visibility.

Device Settings: Date & Time

Setting Device Date and Time

Change the displayed year, month, day, hour, and minute.

Device Settings: Date Format

Setting Device Date Format

Change date and time format (e.g., YYYY-MM-DD, HH:MM).

Device Settings: Language

Setting Device Language

Change the displayed language (e.g., English, Español). May not be available.

Injection Reminder Alarm Setup

Connecting to the SMARTCLIC App

Syncing Injection Data

Transfer injection information to your smart device. Starts pairing if no device is paired.

App Syncing Options

Set automatic transfer of injection information. Press icon on App for data.

App Setup: Pairing and Forgetting Devices

Pairing Your Device

Pair your Device to your smart device. If already paired, option to forget current pairing.

Forgetting Paired Devices

Disconnect your Device from your smart device. Ask to forget connected device if already paired.

Connect App Troubleshooting

Device Information

Checking Device Expiration

View the remaining operational period of your Device.

Checking Device Version

View the version details of your Device.

Checking Device Serial Number

View the Serial Number of your Device.

Viewing Legal Information

View the legal details of your Device.

Power Off Device

Chapter 6: Error Messages

Device Error: Do Not Use

Device stopped working. Contact healthcare professional.

Device Error: Do Not Inject

Device cannot give an injection. Contact healthcare professional.

Error: Cannot Release Needle Guard

Needle guard blocked. Needle may be exposed. Contact healthcare professional.

Error Messages: Communication and Battery

Error: Communication Control Failed

Communication function not operated properly. Set pairing again.

Error: Low Battery

Device battery life is low. Request a new Device.

Error: Inject Function Expired

Inject function reached end of usable life. Request a new Device.

Error: Device Reached Expiry

Device reached the end of its usable life. Request a new Device.

Error: Device Too Warm

Device temperature too warm. Leave at room temp until cooled.

Error: Device Too Cold

Device temperature too cold. Leave at room temp until warmed.

Error Messages: Cartridge and Injection Issues

Error: Cartridge Detection Failure

Device failed to detect Cartridge. Turn off/on, check pairing.

Error: Training Function Expired

Training limit exceeded. Cannot perform more training injections.

Error: Cartridge Expired

Inserted Cartridge expired and cannot be used. Eject and insert new cartridge.

Error: Wrong Cartridge

Inserted Cartridge unusable. Eject and insert new cartridge.

Error: Used Cartridge

Device recognized previously inserted cartridge. Eject and insert new cartridge.

Error: Do Not Re-attach Cap

Needle cap replaced before injecting. Eject cartridge.

Error: Cannot Insert Needle

Error during injection. Dose not injected fully. Eject cartridge.

Error: Incomplete Injection Dose

Error during injection. Dose not injected fully. Contact healthcare professional.

Reminder: Remove Cartridge

Reminder to remove cartridge from Device.

Error: Pairing Failed

Device not paired with phone or tablet. Retry pairing sequence.

Error: Smart Device Not Found

Device failed to find connection to phone or tablet. Check Bluetooth, retry pairing.

Troubleshooting Common Issues

Electronic Waste Disposal Information

Disposal of Waste Batteries

Technical Information: Device Disposal

Technical Information: Symbols

Technical Information: Font Usage

Technical Information: BSD License

Technical Information: EMC Compliance

Technical Information: RF Immunity - Part 1

Technical Information: RF Immunity - Part 2

Manufacturer Information

Enbrel SMARTCLIC APP-1000 Specifications

General IconGeneral
Device CategoryMedical Equipment
Device TypeAutoinjector
Brand NameEnbrel
ModelSMARTCLIC APP-1000
UsageSubcutaneous Injection
Drug CompatibilityEnbrel (Etanercept)
Needle ShieldYes
Needle VisibilityNo
Dose AdjustmentNo
Injection Speed ControlNo
ReusableNo
Single UseYes
SterilitySterile

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