Enbrel AutoTouch Connect User Manual Download Page 41

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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

Magnetic Resonance
(MR) Unsafe

Summary of Contents for AutoTouch Connect

Page 1: ...AutoTouch ConnectTM reusable autoinjector for use with Enbrel Mini etanercept single dose prefilled cartridge User Manual...

Page 2: ......

Page 3: ...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 featur...

Page 4: ...ider for injection training and use the Instructions for Use included in the carton Instructions for Use A fold out step by step Instructions for Use is provided in the carton which provides you with...

Page 5: ...ve purple cap Injection is finished when you hear a chime and all lights are turned off 5 To start injection Press and release the green status button Status button flashes Labeled side 2 4 Prepare an...

Page 6: ...t 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 8...

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Page 8: ...Guide to Parts AutoTouch ConnectTM reusable autoinjector Finger grip Door button Viewing window Door...

Page 9: ...an injection you can look through this window and see the plunger lowering to deliver your medicine When AutoTouch Connect is awake the viewing window will light up If Enbrel Mini is in AutoTouch Conn...

Page 10: ...Guide to Parts AutoTouch ConnectTM reusable autoinjector Status button Speaker Error symbols Progress bar Speed switch...

Page 11: ...r 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 prog...

Page 12: ...Guide to Parts AutoTouch ConnectTM reusable autoinjector Sound switch Injection end...

Page 13: ...in 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 gre...

Page 14: ...ngle dose prefilled cartridge Before use Labeled side Expiration date Medicine Purple cap on Enbrel Mini window with medicine After use Important The needle is inside Enbrel Mini Enbrel Mini window wi...

Page 15: ...ook to examine your medicine before starting an injection See Instructions for Use for more information Purple cap The purple cap keeps your medicine safe Do not remove the cap on Enbrel Mini before l...

Page 16: ...Guide to Parts AutoTouch ConnectTM reusable autoinjector Plunger rod Enbrel Mini single dose prefilled cartridge loaded...

Page 17: ...will hear Needle insertion and plunger rod are operated by motors You will hear a motor noise as the rod moves down and then back up again Whenever you hear a motorized noise you will know that an in...

Page 18: ...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 possibl...

Page 19: ...d Problem The AutoTouch Connect reusable autoinjector battery is dead Action Call the 1 888 4ENBREL 1 888 436 2735 for a replacement AutoTouch Connect reusable autoinjector Too hot or cold Symbol Oran...

Page 20: ...nbrel Mini Make sure to leave the purple cap on until Enbrel Mini has been placed inside the AutoTouch ConnectTM reusable autoinjector and the door is closed Call 1 888 4ENBREL 1 888 436 2735 for a re...

Page 21: ...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 If you have not given yourself...

Page 22: ...an incomplete dose may have been injected Call your healthcare provider if you feel you have given yourself an incomplete injection Call 1 888 4ENBREL 1 888 436 2735 for further assistance with your...

Page 23: ...ld begin blinking and a chime should sound While the failure symbol is blinking press and hold door button until all symbols are temporarily displayed and the status button blinks green The door butto...

Page 24: ...ert 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 holdi...

Page 25: ...ch Connect may be asleep To conserve battery power AutoTouch Connect goes into a sleep mode after three minutes of no activity If it seems unresponsive asleep remove AutoTouch Connect from your skin a...

Page 26: ...ring injection may lead to an incomplete dose 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...

Page 27: ...remove The purple cap should not be removed outside of the AutoTouch Connect reusable autoinjector It should be removed after it is loaded into AutoTouch Connect when you are ready to inject If Enbrel...

Page 28: ...room Handling AutoTouch Connect reusable autoinjector Do Do Not Do inspect AutoTouch Connect for physical damage or defects before each use Do not use AutoTouch Connect if it has been dropped on a har...

Page 29: ...with the labeled side facing out and slide into the door Do not force Enbrel Mini into the door Do not use Enbrel Mini if it has been dropped on a hard surface Do put Enbrel Mini in the door before r...

Page 30: ...e 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...

Page 31: ...enings in the injection end or open door Keep AutoTouch Connect and Enbrel Mini out of the reach of children If AutoTouch Connect fails the maximum amount of medicine you could receive is the contents...

Page 32: ...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 For questions about the Embark app and this fe...

Page 33: ...r mobile device then open and close the AutoTouch Connect door No patient information is stored What to do if you lose your phone or get a new phone The Embark app can only be synced to one mobile dev...

Page 34: ...ot be made without the written consent of Amgen Unauthorized modification may void the authority granted under FCC rules permitting the operation of AutoTouch Connect AutoTouch Connect has been tested...

Page 35: ...following measures Reorient or relocate the receiving antenna Increase the separation between AutoTouch Connect and interference receiver Consult the dealer or an experienced radio TV technician for...

Page 36: ...arton Environmental Operating Range AutoTouch Connect will operate in the temperature range of 50 F to 104 F 10 C to 40 C and 20 to 90 relative humidity and at elevations from 197 feet below sea level...

Page 37: ...tion 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...

Page 38: ...ectromagnetic 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...

Page 39: ...er frequency magnetic fields should be that of typical commercial or hospital environment RF Electro magnetic Field IEC 61000 4 3 10 V m 80 MHz 2 5 GHz E1 10 V m 26 MHz 2 7 GHz Portable and mobile RF...

Page 40: ...is electrically isolated from the battery The injection end and finger grip of AutoTouch ConnectTM are made of ABS plastic This material has been biocompatibility tested for skin sensitivity and irri...

Page 41: ...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 p...

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