Related Manuals for Enbrel AutoTouch Connect
Summary of Contents for Enbrel AutoTouch Connect
- Page 1 AutoTouch Connect reusable autoinjector for use with Enbrel Mini ® (etanercept) single-dose prefilled cartridge User Manual...
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Page 3: Table Of Contents
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 ......... 31 What is the Bluetooth wireless ®... -
Page 4: Getting Started
Getting Started This User Manual contains helpful information about your AutoTouch Connect 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... -
Page 5: Reference Guide
Reference Guide... -
Page 6: Resources
® 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... -
Page 8: Guide To Parts
Guide to Parts AutoTouch Connect reusable autoinjector Finger grip Door button Viewing window Door... - Page 9 When AutoTouch Connect is awake, the viewing window will light up. If Enbrel Mini is in AutoTouch Connect, and the viewing window has no light, then press the status button to wake up AutoTouch Connect.
- Page 10 Guide to Parts AutoTouch Connect reusable autoinjector Status button Speaker Error symbols Progress bar Speed switch...
- Page 11 The lights will disappear when your injection is finished. Speed switch The AutoTouch Connect reusable autoinjector allows you to choose from three injection speeds. The pre-set speed is medium.
- Page 12 Guide to Parts AutoTouch Connect reusable autoinjector Sound switch Injection end...
- Page 13 Hold the injection end flat and steady on your skin throughout the entire injection process. Site light When the Enbrel Mini ® single-dose prefilled cartridge is loaded and the purple cap is removed, the injection end will light up to help...
- Page 14 Guide to Parts Enbrel Mini ® single-dose prefilled cartridge Before use Labeled side Expiration date Enbrel Mini window Medicine (with medicine) Purple cap on After use Enbrel Mini window (without medicine) Important: The needle is inside Enbrel Mini Purple cap off...
- Page 15 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 Connect reusable autoinjector. Expiration date Confirm expiration date printed on the label has not passed.
- Page 16 Guide to Parts AutoTouch Connect reusable autoinjector Plunger rod Enbrel Mini ® single-dose prefilled cartridge (loaded)
- Page 17 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.
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Page 18: Troubleshooting: Error Symbols
Troubleshooting: Error Symbols Error Symbols The AutoTouch Connect 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... - Page 19 Then try again. Store the AutoTouch Connect reusable autoinjector in a dry, safe place, such as a cabinet or drawer at 50 °F to...
- Page 20 Mini. Action: Wait for the error to clear and close the door without Enbrel Mini in, and try again with a new Enbrel Mini. Make sure to leave the purple cap on until Enbrel Mini has been placed inside the AutoTouch Connect...
- Page 21 ® 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.
- Page 22 Use caution when both Enbrel Mini problem symbol and the AutoTouch Connect reusable autoinjector failure symbols are lit as the needle may be exposed. Take special care when removing and handling Enbrel Mini. Remove Enbrel Mini then put it in an FDA-cleared sharps disposal container.
- Page 23 The door button should be held for at least 10 seconds. After a successful reset, if an Enbrel Mini ® single-dose prefilled cartridge is still inside AutoTouch Connect, remove it. Close the AutoTouch Connect door.
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Page 24: Troubleshooting: Common Problems
® 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. - Page 25 This will happen if the purple cap has been removed before inserting Enbrel Mini into the door. Do not reuse or recap. Begin again using a new Enbrel Mini. Do not remove the purple cap until after Enbrel Mini has been...
- Page 26 AutoTouch Connect door will not remain closed. Reason #1: At the end of an injection, the door cannot be closed with a used Enbrel Mini ® single-dose prefilled cartridge inside. Reason #2: When AutoTouch Connect experiences a failure, the door will open and remain open.
- Page 27 Connect reusable autoinjector. It should be removed after it is loaded into AutoTouch Connect, when you are ready to inject. If Enbrel Mini is loaded and the purple cap is difficult to remove, call 1-888-4ENBREL (1-888-436-2735). The injection speed will not change during injection.
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Page 28: Storage & Handling
Storage AutoTouch Connect reusable autoinjector Do Not store AutoTouch Do not store Connect in dry, safe AutoTouch Connect in place at room the refrigerator with temperature such as a the Enbrel Mini ® cabinet or drawer. single-dose prefilled cartridges. store AutoTouch... - Page 29 Enbrel Mini ® single-dose prefilled cartridge Do Not store unused Do not freeze the Enbrel Mini in the unused Enbrel Mini. refrigerator. Do not warm Enbrel Mini using a heat source such as hot water or a microwave. make sure to hold...
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Page 30: Cleaning Instructions
AutoTouch Connect before and after injections. use an alcohol Do not immerse wipe to clean all other AutoTouch Connect in areas of AutoTouch water. Connect as desired. Do not wipe AutoTouch Connect with household cleanser or soap. -
Page 31: Warnings
Warnings No modification of the AutoTouch Connect 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. -
Page 32: What Is The Bluetooth Wireless Feature
Instructions for Use. To use this feature, download and set up the Embark ® − Patient Support app. After Embark is set up and paired with AutoTouch Connect, follow all injection instructions as you normally would. AutoTouch Connect transmits a signal to the Embark app on your mobile device and keeps track of your Enbrel injections. - Page 33 Embark app for up to 48 hours after every injection. To sync at any time, bring AutoTouch Connect next to your mobile device, then open and close the AutoTouch Connect door. No patient information is stored.
- Page 34 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. AutoTouch Connect must accept any interference received, including interference that may cause undesirable operation.
- Page 35 If AutoTouch Connect does cause harmful interference to radio or television reception, which can be determined by moving AutoTouch Connect far away and back, the user is encouraged to try to correct the interference by one or more of the following measures: •...
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Page 36: Technical Information
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. Environmental Operating... - Page 37 The Bluetooth technology in the AutoTouch Connect complies with the Bluetooth Core Specification v5.0 and is qualified by Bluetooth SIG. The AutoTouch Connect has been designed to transmit default 0dBm standard industrial, scientific and medical (ISM) 2.4 GHz band radio frequency (RF) and covers up to 10 meters communication range.
- Page 38 Connect near high magnetic or other fields such as those around MRI, CAT, or PET scanners. AutoTouch Connect emits RF. 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.
- Page 39 30 Electrical characteristics The AutoTouch Connect 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.
- Page 40 AutoTouch Connect are made of ABS plastic. This material has been biocompatibility-tested for skin sensitivity and irritation. Contraindications This device is contraindicated for use in a Magnetic Resonance (MR) environment. For contraindications of ENBREL ® please refer to ENBREL prescribing information.
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Page 41: Symbol Table
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. CAUTION, consult accompanying documents Refer to instructions for use Do not use if package is damaged This product contains dry natural rubber... - Page 42 Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799 ©2021 Immunex Corporation. All rights reserved. [partnumber] Revised: 04/2021 v1 This printed material is recyclable.
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