AutoTouch ConnectTM reusable autoinjector for use with Enbrel Mini® (etanercept) single-dose prefilled cartridge User Manual ILL2316 v1 ILL0963 v1
Table of Contents Getting Started..............................................4 Reference Guide............................................5 Resources.....................................................6 Guide to Parts................................................8 Troubleshooting: Error Symbols....................18 Troubleshooting: Common Problems............24 Storage & Handling......................................28 Cleaning Instructions...................................30 Warnings................
Getting Started This User Manual contains helpful information about your AutoTouch ConnectTM reusable autoinjector (AutoTouch Connect). It includes resources, care details, and a troubleshooting guide to save for ongoing reference. To learn how to inject using AutoTouch Connect, see your healthcare provider for injection training and use the Instructions for Use included in the carton.
Labeled side 4 v2 ILL098 4 Thigh 2 3 5 v4 To start injection: Press and release the green status button. ILL012 Stomach area (abdomen) Upper arm 5 v7 096 Place and hold on skin. Wait for the status button to turn green. 1 Status button flashes 5 ILL0985 v2 Injection is finished when you hear a chime and all lights are turned off. ILL0974 v5 Hold the Enbrel Mini® single-dose prefilled cartridge with labeled side facing out and slide into door. Close door. Remove purple cap.
Resources ENBREL Support ® provides personalized support services to ENBREL® patients, at no additional cost, including: • Information about financial support options • Supplemental injection training with an ENBREL Nurse Partner ™ • Educational materials to help support you along the way Call 1-888-4ENBREL (1-888-436-2735) to enroll or visit www.EnbrelSupport.com to find out more.
Guide to Parts AutoTouch ConnectTM reusable autoinjector Finger grip Door button Viewing window Door ILL0968 v3 8
Finger grip When injecting, hold the AutoTouch ConnectTM reusable autoinjector with fingers wrapped around the gray finger grip. ILL0972 v2 Door button Press this button to open the door for insertion of the Enbrel Mini® single-dose prefilled cartridge. When your injection is finished, the door will open automatically. Viewing window During an injection, you can look through this window and see the plunger lowering to deliver your medicine.
Guide to Parts AutoTouch ConnectTM reusable autoinjector Status button Speaker Error symbols Progress bar Speed switch ILL0969 v3 10
Status button Press this button to begin an injection. Lights will indicate the status of your injection. Green: Ready to press and start injection. Blinking green: The needle is inserting and your injection is in progress. Red: An error has occurred. See the Troubleshooting section of this manual. Progress bar These stacked green bars are fully lit when your injection starts, and the bar of lights decrease as your injection is in progress. The lights will disappear when your injection is finished.
Guide to Parts AutoTouch ConnectTM reusable autoinjector Sound switch ILL0970 v2 Injection end 12
Sound switch Sounds can be turned off and on. (Sounds on) Slide switch down. (Sounds off) Slide switch up so that the red bar is visible. Note: Error sounds will still be heard if the sounds have been turned off. Injection end The entire injection end must be touching your skin during injections. This is also where the needle will come out. Skin sensor A skin sensor is located on the injection end. When the injection end is placed on skin the start button light will turn green.
Guide to Parts Enbrel Mini® single-dose prefilled cartridge Before use Labeled side Expiration date Enbrel Mini window (with medicine) Medicine ILL2315 v1 Purple cap on After use ILL2314 v1 Important: The needle is inside Enbrel Mini Enbrel Mini window (without medicine) Purple cap off 14
Labeled side When inserting the Enbrel Mini® cartridge make certain that the labeled side is facing out. Then slide Enbrel Mini into the door. It will slide all the way down into the AutoTouch ConnectTM reusable autoinjector. Expiration date Confirm expiration date printed on the label has not passed. Enbrel Mini window This is where you will look to examine your medicine before starting an injection. See Instructions for Use for more information. Purple cap The purple cap keeps your medicine safe.
Guide to Parts AutoTouch ConnectTM reusable autoinjector Plunger rod Enbrel Mini® single-dose prefilled cartridge (loaded) ILL0971 v3 16
How it works. When you push the status button to start an injection, the AutoTouch ConnectTM reusable autoinjector pushes a hidden needle out of the Enbrel Mini® single-dose prefilled cartridge into your skin. Then, a plunger rod will push into Enbrel Mini, injecting medicine into your body. After the medicine is injected, the rod will pull back up and the needle will withdraw from your skin. After a successful injection all lights will turn off and the door will open.
Troubleshooting: Error Symbols Error Symbols The AutoTouch ConnectTM reusable autoinjector makes a chime sound, lights the status button red, and displays an error symbol if there is a problem. See the following description of each error symbol, possible reasons for the error, and actions you can take.
Low battery Symbol: Red battery and error sound. Problem: The battery is running very low. Less than three weeks or three injections remain. The battery is not replaceable or rechargeable. Action: Call 1-888-4ENBREL (1-888-436-2735) for a replacement AutoTouch ConnectTM reusable autoinjector. Battery dead Symbol: Red battery and red triangle with exclamation point, red status button, and error sound. Problem: The AutoTouch Connect reusable autoinjector battery is dead.
Troubleshooting: Error Symbols Enbrel Mini® problem Symbol: Orange Enbrel Mini single-dose prefilled cartridge with blinking red status button and error alert sound. Problem: There are five possible reasons you are getting this error. Please read below. Problem #1: The purple cap was removed before inserting Enbrel Mini. Action: Wait for the error to clear and close the door without Enbrel Mini in, and try again with a new Enbrel Mini.
Problem #3: Enbrel Mini® single-dose prefilled cartridge is defective or not recognized as an Amgen product. Action: Remove Enbrel Mini. Replace with a new Enbrel Mini. Call 1-888-4ENBREL (1-888-436-2735) for a replacement Enbrel Mini. Problem #4: Door is held closed for more than one minute. Action: Remove your hand from the door. When the door opens, remove Enbrel Mini from AutoTouch ConnectTM, if present. Wait for the error symbol to stop blinking and close the door.
Troubleshooting: Error Symbols Needle Exposure Symbol: Orange Enbrel Mini® single-dose prefilled cartridge, a red triangle with an exclamation point, red status button, and error sound. Problem: A problem occurred during an injection and the needle may be exposed. Action: If there is still fluid in Enbrel Mini, an incomplete dose may have been injected. Call your healthcare provider if you feel you have given yourself an incomplete injection.
AutoTouch ConnectTM Reusable Autoinjector Failure Symbol: Red triangle with an exclamation point, red status button, and error sound. Problem: Several errors have occurred or AutoTouch Connect has stopped working. Action: Reset AutoTouch Connect. To reset AutoTouch Connect: Hold AutoTouch Connect away from skin and press the status button to wake AutoTouch Connect. The failure symbol should begin blinking and a chime should sound.
Troubleshooting: Common Problems Common Problems Enbrel Mini® single-dose prefilled cartridge is difficult to insert into the door. Never force Enbrel Mini into the door. When positioned correctly, it will fall freely and completely into and out of the door. If it is difficult to load, double check that you are holding Enbrel Mini as shown.
Injection does not start when pressing the status button. Reason #1: Place the AutoTouch ConnectTM reusable autoinjector on your skin and wait for the status button to turn green. A skin sensor is located on the injection end. You cannot start an injection unless the injection end of AutoTouch Connect is touching your skin. Hold the injection end on your skin throughout the entire injection. Reason #2: AutoTouch Connect may be asleep.
Troubleshooting: Common Problems Injection aborts or an error symbol appears while the injection is in process. The AutoTouch ConnectTM reusable autoinjector will abort an injection if the sensor loses skin contact. Avoid adjusting or moving AutoTouch Connect during an injection. Hold AutoTouch Connect on your skin until the green status light turns off and the injection is finished. Shifting, repositioning or lifting from your skin during injection may lead to an incomplete dose.
Enbrel Mini® single-dose prefilled cartridge will not eject. Reason #1: If the viewing window has no light, press the status button to wake up AutoTouch ConnectTM. Then press and hold the door button for at least two seconds to eject. Reason #2: If Enbrel Mini does not eject automatically at the end of an injection, there may be a problem. Call 1-888-4ENBREL (1-888-436-2735). The purple cap is very hard to remove. The purple cap should not be removed outside of the AutoTouch Connect reusable autoinjector.
Storage & Handling Storage AutoTouch ConnectTM reusable autoinjector Do Do Not Do store AutoTouch Connect in dry, safe place at room temperature such as a cabinet or drawer. Do not store AutoTouch Connect in the refrigerator with the Enbrel Mini® single-dose prefilled cartridges. Do store AutoTouch Connect in its carton when not in use. Do not store AutoTouch Connect in extreme heat or cold, or in highly humid environments like the bathroom.
Storage and Handling Enbrel Mini® single-dose prefilled cartridge Do Do Not Do store unused Enbrel Mini in the refrigerator. Do not freeze the unused Enbrel Mini. Do not warm Enbrel Mini using a heat source such as hot water or a microwave. Do make sure to hold Enbrel Mini with the labeled side facing out and slide into the door. Do not force Enbrel Mini into the door. Do put Enbrel Mini in the door before removing the purple cap.
Cleaning Instructions Cleaning AutoTouch ConnectTM reusable autoinjector Do Do Not Do use an alcohol wipe to clean the injection end of AutoTouch Connect before and after injections. Do not clean AutoTouch Connect with water. Do use an alcohol wipe to clean all other areas of AutoTouch Connect as desired. Do not immerse AutoTouch Connect in water. Do not wipe AutoTouch Connect with household cleanser or soap.
Warnings No modification of the AutoTouch ConnectTM reusable autoinjector is allowed. No part of AutoTouch Connect can be repaired or replaced, including the battery. Do not put anything inside the door other than an Enbrel Mini® single-dose prefilled cartridge. Do not immerse AutoTouch Connect in water. Do not reach inside AutoTouch Connect. Do not crush, burn or heat AutoTouch Connect. AutoTouch Connect contains moving parts. Keep your fingers out of openings in the injection end or open door.
What is the Bluetooth® wireless feature? This AutoTouch ConnectTM reusable autoinjector has an optional Bluetooth ® wireless feature to automatically record your injections. This wireless feature will not affect your injection steps. Whether or not you use this wireless feature, please make sure you follow steps in the Instructions for Use. To use this feature, download and set up the Embark® − Patient Support app.
Pairing AutoTouch ConnectTM When setting up the Embark® app, bring AutoTouch Connect next to your mobile device, then open and close the AutoTouch Connect door. The Embark app will guide you through pairing your AutoTouch Connect reusable autoinjector. The AutoTouch Connect uses standard Bluetooth® authentication and encryption for its wireless data security. Once paired, AutoTouch Connect will try to sync with the Embark app for up to 48 hours after every injection.
What is the Bluetooth® wireless feature? Important Information Required by the Federal Communications Commission (FCC) FCCID: 2AGZ4–ATCONNECT The AutoTouch ConnectTM reusable autoinjector contains a Bluetooth ® wireless feature. AutoTouch Connect complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. AutoTouch Connect may not cause harmful interference. 2.
installation. AutoTouch Connect generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
Technical Information International Protection Rating The international protection code for the AutoTouch ConnectTM reusable autoinjector when stored in its carton is IP52. Which means it is protected from limited dust ingress and from limited dripping water. AutoTouch Connect is not rated for dust or fluid ingress when not stored in its carton.
Quality of Service and Security Information The AutoTouch ConnectTM autoinjector establishes an authenticated and encrypted connection with the Embark® app running on a mobile device. Initial setup requires physical access to the autoinjector labeled serial number for user input at initial pairing/secure bonding. The app will walk you through this setup process. Data is transferred from the autoinjector on a one-to-one paired mobile device for ensuring data integrity and quality of service (QoS).
Technical Information Electromagnetic Emissions The autoinjector is intended for use in the electromagnetic environment specified below. The user of the autoinjector should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions (CISPR 11) Group 1 The autoinjector uses RF energy for its internal and system interface functions. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Electromagnetic Immunity The autoinjector is intended for use in the electromagnetic environment specified below. The user of this autoinjector should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic EnvironmentGuidance Electrostatic Discharge (ESD) IEC 61000-4-2 ±8 kV Contact ±15 kV Air ±15 kV Contact ±20 kV Air Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%.
Technical Information Electrical characteristics The AutoTouch ConnectTM reusable autoinjector uses a non-replaceable, non-rechargeable DL123 Lithium battery. The battery has a nominal voltage of 3.0 V with a capacity of 1400 mAh. The autoinjector enclosure is a Type BF applied part: The skin sensor and other electronics are isolated from the skin. Dimensions and weight AutoTouch Connect weighs 0.4 pounds (180 grams), and is 9 inches (228 mm) tall by 1.5 inches (38 mm) wide by 1.8 inches (45 mm) deep.
Symbol Table Do not re-use Use-by date (Exp. date) Lot number Keep dry Serial number Type BF applied part The autoinjector enclosure is a Type BF applied part.
Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799 ©2021 Immunex Corporation. All rights reserved. ACM0179 Revised: 04/2021 v1 This printed material is recyclable.
