This User Manual contains helpful information about your AutoTouch® reusable autoinjector. It includes resources, care details, and a troubleshooting guide to save for ongoing reference.
To learn how to inject using AutoTouch, see your healthcare provider 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 full instructions to learn how to give yourself a safe, successful and accurate injection.
Note: Please read the full Instructions for Use included in the carton.
The Reference Guide on the next page should only be used when you have successfully completed an injection using the Instructions for Use.
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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. When AutoTouch is awake, the viewing window will light up. If Enbrel Mini is in AutoTouch, and the viewing window has no light, then press the status button to wake up AutoTouch.
You will open this door and insert Enbrel Mini into AutoTouch. The door will open automatically when your injection is finished. When inserted properly, Enbrel Mini will slide freely and completely into and out of the door.
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.
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. 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 you see your injection site.
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® 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. Do not remove the cap on Enbrel Mini before loading it into AutoTouch. Load Enbrel Mini with the purple cap on, and remove the cap only when you are ready to give yourself the injection. Do not leave the purple cap off for more than five minutes. This can dry out the medicine.
See the Instructions for Use for more detail about loading Enbrel Mini and when to remove the purple cap.
When you push the status button to start an injection, the AutoTouch® 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. The needle stays hidden at all times during the injection process.
What you 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 injection is in progress.
What you will see.
During the injection, the viewing window light will be on, and the plunger rod will move through the window. Also during the injection, the status light will be flashing green, and the progress bar will decrease. After a successful injection, the progress bar, and status button will turn off, and AutoTouch will open the door.
If the status light turns red, and beeps for more than a few seconds, an error has occurred. Use the troubleshooting section of this manual to see what to do if this happens.
Error Symbols
The AutoTouch® 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.
Symbol: Orange battery and error sound.
Problem: The battery is running very low. Less than three weeks or three injections remain. The battery has a life of two years or 130 injections from your first injection. The battery is not replaceable or rechargeable.
Action: Call 1-888-4ENBREL (1-888-436-2735) for a replacement AutoTouch reusable autoinjector.
Symbol: Orange sun and a snowflake, and an error sound.
Problem: AutoTouch is too hot or too cold. This will lock the door.
Action: Place AutoTouch at room temperature in a safe, dry place and allow it to naturally cool or warm to room temperature. Then try again. Store the AutoTouch reusable autoinjector in a dry, safe place, such as a cabinet or drawer at 50° F to 104° F (10° C to 40° C).
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. Make sure to leave the purple cap on until Enbrel Mini has been placed inside the AutoTouch® reusable autoinjector and the door is closed. Call 1-888-4ENBREL (1-888-436-2735) for a replacement Enbrel Mini.
Problem #2: Sensor lost skin contact during injection.
Action: Hold the injection end of AutoTouch on your skin throughout the entire injection until the green status button turns off, even if the motor sounds stop. Lifting or shifting on your skin during injection may lead to an incomplete injection. Call your healthcare provider if you feel you have given yourself an incomplete injection.
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®, if present. Wait for the error symbol to stop blinking and close the door. If you have not given yourself an injection, place a new Enbrel Mini in AutoTouch and continue. If the error symbol remains on, call 1-888-4ENBREL (1-888-436-2735).
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. Call 1-888-4ENBREL (1-888-436-2735) for further assistance with your AutoTouch®.
Use caution when both Enbrel Mini problem symbol and the AutoTouch® 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 a FDA-cleared sharps disposal container.
Hold AutoTouch away from skin and press the status button to wake AutoTouch. The failure symbol should 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 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, remove it. Close the AutoTouch door. Then, for the next injection, start by pressing the door button to open Enbrel Mini door.
If AutoTouch does not respond after three attempts to reset, call 1-888-4ENBREL (1-888-436-2735).
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® 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 is touching your skin. Hold the injection end on your skin throughout the entire injection.
Reason #2: AutoTouch may be asleep. To conserve battery power, AutoTouch goes into a "sleep mode" after three minutes of no activity. If it seems unresponsive/asleep, remove AutoTouch from your skin and press the status button to wake it up.
No part of AutoTouch can be repaired or replaced, including the battery.
Do not put anything inside the door other than an Enbrel Mini® single-dose prefilled cartridge.
AutoTouch contains moving parts. Keep your fingers out of openings in the injection end or open door.
Keep AutoTouch and Enbrel Mini out of the reach of children.
If AutoTouch fails, the maximum amount of medicine you could receive is the contents of the full Enbrel Mini, which is the correct dose.
Use caution if an error occurs as the needle may be exposed.
Carefully dispose of Enbrel Mini in an FDA approved sharps container.
Call your healthcare provider if you have any concerns regarding an incomplete injection.
When travelling, keep AutoTouch with you, in your carry-on bags.
Do not dispose of AutoTouch in the household trash. Call 1-888-4ENBREL (1-888-436-2735) for a replacement.
International Protection Rating
The international protection code for the AutoTouch® reusable autoinjector when stored in its carton is IP52. Which means it is protected from limited dust ingress and from limited dripping water. AutoTouch is not rated for dust or fluid ingress when not stored in its carton.
Environmental Operating Range
AutoTouch 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 to 11,483 feet above sea level (-60 m to 3500 m).
Environmental Storage Range
Transport and store AutoTouch in its carton, in a dry place at room temperature: 50° F to 104° F (10° C to 40° C). AutoTouch been tested to a brief exposure at -40° F to 158° F (-40° C to 70° C), 50% relative humidity, and pressure equivalent of 14000 ft (4267 m).
Electromagnetic Compatibility
Avoid operating AutoTouch near microwave ovens, wireless routers, baby monitors or other common household electronics that operate using RF transmission. Two meters (six feet) is a reasonable distance.
Avoid operating AutoTouch near high magnetic or other fields such as those around MRI, CAT, or PET scanners.
The AutoTouch® 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 expected service life of AutoTouch is two years or 130 injections from the first injection.
AutoTouch has a Type BF applied part: it has a capacitive electrical sensor that is isolated by plastic from the skin.
Dimensions and weight
AutoTouch 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.
Biocompatibility and electrical isolation
The injection end of the reusable autoinjector 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 are made of ABS plastic. This material has been biocompatibility-tested for skin sensitivity and irritation.