ACCU-CHEK Spirit 3.15ml Cartridge System Instruction Manual

: June 10, 2024
: ACCU-CHEK

Table of Contents

ACCU-CHEK Spirit 3.15ml Cartridge System
Product Information
Product Usage Instructions
HOW TO USE
Instructions for Use
WARNING
Disposal
Contact
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ACCU-CHEK Spirit 3.15ml Cartridge System

Product Information

The Accu-Chek Spirit Combo is a 3.15 ml cartridge system for insulin pumps manufactured in Poland by Roche. The product is distributed in the United States by Roche Diabetes Care Inc., Indianapolis, IN 46256, USA. The product is also distributed in other countries such as the United Kingdom, Australia, South Africa, Canada, Singapore, Italy, Switzerland, Colombia, the Netherlands, Denmark, Norway, Sweden, and Greece. The product contains small parts that may cause choking hazards and should be kept out of reach of children and individuals who may ingest them.

Product Usage Instructions

The Accu-Chek Spirit Combo is an insulin pump cartridge system that should be used only under the guidance of a healthcare professional. Before using the product, read the instructions for use carefully. Ensure that you have all the necessary equipment and supplies before starting to use the product. The product should be used only with the Accu-Chek Spirit Combo insulin pump. Do not use the product if the packaging is damaged or opened. Follow the instructions provided by your healthcare professional for filling the cartridge with insulin and inserting it into the pump. Inspect the tubing and infusion set before each use to ensure that there are no leaks or blockages. Follow the instructions provided by your healthcare professional for priming the tubing and infusion set before using the pump. Monitor your blood glucose levels regularly and adjust the pump settings as directed by your healthcare professional. If you experience any problems or issues with the product, contact your healthcare professional or Roche Diabetes Care Inc. for assistance.

HOW TO USE

ACCU-CHEK-Spirit-3.15ml-Cartridge-System-FIG-1

Instructions for Use

Carefully read these instructions for use, the User’s Manual of your insulin pump and the instructions for use of the infusion set before using the cartridge system. The cartridge is intended to be used as an insulin reservoir in compatible Accu-Chek insulin pumps. Compatible insulin pumps are the Accu- Chek Spirit and the Accu-Chek Spirit Combo insulin pumps used together with their compatible infusion sets.

For use in the therapy of diabetes mellitus.
For use by people with diabetes and healthcare professionals or caregivers who assist people with diabetes.
No clinical experience in the use of neonates.
For use with insulin or insulin analogs.
For single use only.
Sterile product sterilized with ethylene oxide. The cartridge system consists of a cartridge and a pre-mounted filling aid. The filling aid is used to fill insulin from commercially available 10 mL insulin vials into the cartridge.

WARNING

Risk of suffocation
This product contains small parts that can be swallowed. Keep the small parts away from small children and people who might swallow small parts.
Risk of infection
Visually inspect the sterile packaging. If the packaging is damaged or already open, do not use the product. The product can be unsterile. Do not use products that have passed their use by date. Expired products can be unsterile.Operating conditions: 5–40 °C (41–104 °F), 20–90 % relative humidity Storage conditions: 5–55 °C (41–131 °F), 5–85 % relative humidity, undamaged blister, dry and away from sunlight Discard the used product according to local regulations. For information on how to discard the product correctly, contact your local council or authority. Reporting of serious incidents: see the instructions for use of the infusion set.
In US, distributed by:
Roche Diabetes Care, Inc. Indianapolis, IN 46256, USA Accu-Chek Customer Care: 1-800-688-4578 www.accu- chek.com.
Distributed in the United Kingdom by:
Roche Diabetes Care Limited Charles Avenue, Burgess Hill West Sussex, RH15 9RY, United Kingdom Accu-Chek Pump Careline 1): UK Freephone number: 0800 731 22 91 ROI Freephone number: 1 800 88 23 51

calls may be recorded for training purposes Some mobile operators may charge for calls to these numbers.
burgesshill.insulinpumps@roche.com.
www.accu-chek.co.uk.
www.accu-chek.ie.

Australia
Roche Diabetes Care Australia Pty. Limited Insulin Pump Support: 1800 633 457 australia.insulinpumps@roche.com www.accu-chek.com.au. Roche Diabetes Care South Africa (Pty) Ltd. Hertford Office Park, 90 Bekker Road Vorna Valley, 1686
South Africa

Tel: +27 (11) 504 4600
Email: info@accu-chek.co.za
www.rochediabetescaremea.com.

Canada

Accu-Chek Pump Support: 1-800-688-4578 (toll free)
www.accu-chek.ca.

Singapore

Accu-Chek ExtraCare line: 6272 9200
www.accu-chek.com.sg.
D Gebrauchsanweisung

Disposal

Single sterile barrier system

ACCU-CHEK-Spirit-3.15ml-Cartridge-System-FIG-4 Medical device

Unique device identifier

ACCU-CHEK-Spirit-3.15ml-Cartridge-System-FIG-6 Complies with the provisions of the applicable EU Legislation

For an explanation of other symbols refer to the User’s Manual of your insulin pump.

ACCU-CHEK, ACCU-CHEK SPIRIT, and ACCU-CHEK SPIRIT COMBO are trademarks of Roche.

Contact

In the US distributed by: Roche Diabetes Care Inc. Indianapolis, IN 46256, USA
Toll-Free: 1-800-688-4578
M Roche Diabetes Care GmbH
Sandhofer Strasse 116 68305 Mannheim, Germany
www.accu-chek.com.