Enbrel AutoTouch Connect Скачать руководство пользователя страница 40 | Manualshive

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Enbrel AutoTouch Connect Скачать руководство пользователя страница 40

Biocompatibility and electrical
isolation

The autoinjector enclosure is
intended to come into contact with
the skin (see Guide to Parts).  It is
a Type BF applied part.  This
means that it is electrically
isolated from the battery.  The
injection end and finger grip of
AutoTouch Connect

TM

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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Содержание AutoTouch Connect

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

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 7: ......

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

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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