ACCU-CHEK Accu-Fine Pen Needles Instruction Manual

: June 10, 2024
: ACCU-CHEK

Table of Contents

ACCU-CHEK Accu-Fine Pen Needles
Product Information
Product Usage
Instructions for use
Symbols Glossary
Sterile, single-use pen needles
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ACCU-CHEK Accu-Fine Pen Needles

Product Information

The product is a sterile, single-use pen needle designed for injecting medication. The needle is available in various lengths ranging from 4mm to 12mm. The product is manufactured using irradiation to ensure sterility. The packaging material is recyclable, and the product does not contain natural rubber latex.

Product Usage

Before using the product, check the lot number and use-by date mentioned on the packaging. Do not reuse the needle. Always consult the instructions for use before using the product.

The appropriate needle length dependson the user’s age and BMI. Refer to the table provided in the manual for suggested needle lengths based on age and BMI. Consult your healthcare professional for assistance in choosing the appropriate needle length, injection technique, and site. This product is also recommended for people injecting large dosages or with limited dexterity/strength.

Instructions for use

Remove the seal from the pen needle.
Push the pen needle straight on the pen injector device and twist until it is tight (2a). Do not push the pen needle at an angle. Then remove the outer protective cap and set it aside (2b). Do not discard. You will need it later to remove the pen needle from the pen injector device.
Remove the inner protective cap by pulling it straight out to prevent bending of the needle and/or damaging the needle tip.
Prime your pen injector device as per your pen’s instructions for use to prevent incorrect dosage caused by air in the cartridge or a clogged needle. If no drug €ow is seen after several attempts, attach a new pen needle.
Set your drug dose.
Make the injection as directed by your healthcare professional, do not bend the needle. Inject slowly. Do not withdraw needle immediately after injection. Do not change the direction of the pen needle while it remains in the body as this can result in bending or breaking of the needle.
Replace the outer protective cap.
Remove the pen needle from the pen injector device after each injection to prevent air from entering the cartridge and drug from leaking out.
Warning: Remove both the outer protective cap and the inner protective cap before an injection. If both the outer cap and the inner protective cap are not removed before use, the medication or dose may not be injected, which may result in serious injury or death.

Symbols Glossary

References obtained from ISO 15223 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.

| EN
---|---
| Lot number
| Manufacturer
| Use-by date
| Sterilized using irradiation
| Catalog number
| Do not reuse
| Consult instructions for use
| Caution
| Medical Device
| Unique Device Identier
| Explanation of other symbols:
| CE mark
Complies with the provisions of the applicable EU Legislation
| Recyclable packaging material
| Explanation of other terms:
| Not made with natural rubber latex – natural rubber latex was not used as material in the manufacture of the device.

Sterile, single-use pen needles

Intended for use with pen injector devices for the subcutaneous injection of drugs.

NOTE: Read the needle gauge and length on the seal to make sure you are using the right pen needle for you or ask for assistance if you have impaired vision. Also do so, if you are a healthcare professional, a caretaker or a family member assisting a patient.

How to get ready for injection
Choose and disinfect the injection site. Change the injection site often to avoid tissue hardening. You can inject drug into the fatty tissue of the abdomen, buttocks or the outer side or front of the upper thigh. Injections into the upper arm or the inner side of the upper thigh are not recommended as the risk of injecting into a muscle is high.
Injection techniques: The injection site and technique should be recommended to you by your healthcare professional. Recommendation: Injection with a skin fold at a 90° angle. It is recommended that you inject into a skin fold vertically (at a 90° angle) to prevent too deep an injection and hitting the muscle tissue. To make a skin fold when injecting, pinch the skin between the thumb and forefinger and do not pull up the muscle. Injection with a skin fold at a 45° angle. This injection technique is only recommended when you have very little subcutaneous fatty tissue. The minimum angle should be 45°. If the angle is less than 45°, the drug may not reach the subcutaneous fatty tissue and result in weanling or bruising at the injection site. Injection without a skin fold at a 90° angle: if your layer of subcutaneous fatty tissue is very thick, you can make an injection without a skin fold. When you do not use a skin fold, it is recommended that you inject at a 90° angle and choose a short or medium-length needle (up to 6 mm).
See table below for suggested needle length per your age and BMI:

AGE	BMI	NEEDLE LENGTH*
Children <12 Very slim adults		Without skin fold

straight injection

Consult your healthcare professional for assistance in choosing the appropriate needle length, injection technique and site.
Also recommended for people injecting large doseage or with limited dexterity/strength.

CAUTION:
Avoid infections. Do not reuse or share pen needles. Do not use pen needles if the individual packaging is damaged or if the seal is missing or if the needle appears to be damaged. To avoid accidental needlesticks, never handle someone else’s pen needles. Pen needles are single-use only and should be disposed of safely in accordance with the local regulations. Keep out of reach of children without adult supervision.

Remove the inner protective cap by pulling it straight out to prevent bending of the needle and/or damaging the needle tip.

Consult your healthcare professional for assistance in choosing the appropriate needle length and injection technique.
Follow the instructions for use, specic storage and handling recommendations of your pen injector device and the patient information leafet of the drug. Seek immediate medical attention if you have any health concern.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the local competent authorities / government agencies, as applicable.

ACCU-FINE® pen needles are available in 6 versions diÆering in needle diameter and length to meet your individual needs.

ACCU-CHEK-Accu-Fine-Pen-Needles-22

COMPATIBILE WITH MOST PEN INJECTORS AVAILABLE ON THE MARKET:
ACCU-FINE® pen needles are compatible with the following pen injectors available on most markets:
Omnican®Pen 31/32 – BBraun, BerliPen® 301/302/areo/areo2/JUNIOR/PRECISION – Berlin-Chemie, HumaPen® MEMOIR/LUXURA/LUXURA HD/Ergo/Ergo II/savvio, Humalog®KwikPen, Humulin®N Pen, ßyetta® Pen – Eli Lilly,
i-pen②, i-pen – Haselmeier, Autopen®Classic/24 – Owen Mumford, OptiPen®Pro1/Pro2, ClikSTAR®, TactiPen®, SoloSTAR® – Sano Aventis, FlexPen®, FlexTouch®, NovoLet®, NovoPen® 5/4/3 /Junior/Echo, Victoza® pen –
NovoNordisk, GensuPen® – Bioton, Xiu Lin Pen – Ganli Technology, ypsopen® – YPSOMED
ACCU-FINE® pen needles can be used with the following pen injectors available in the USA:
HumaPen® LUXURA HD, HumaPen® Ergo, HumaPen® Ergo II – ELI LILLY, Autopen® – OWEN MUMFORD, TactiPen® – HASELMEIER
Find the detailed list of compatible pen injector devices on: www.htl- strefa.com/products/pen-needles/