The Accu-Chek Inform II is a blood glucose monitoring system designed for professional use in clinical settings, providing accurate and reliable results for multiple patients.
1.1 Indications for Use
The Accu-Chek Inform II system is intended for professional use in clinical settings to measure blood glucose levels in capillary whole blood samples. It is designed for healthcare professionals to monitor glucose levels in multiple patients, aiding in diabetes management. The system is for in vitro diagnostic use only and should be operated by trained personnel. It provides quantitative glucose measurements, essential for assessing glycemic control and making treatment decisions. The system is not intended for personal use or self-monitoring. Always follow the operator’s manual for proper usage and maintenance to ensure accurate results.
1.2 System Components and Contents of the Pack
The Accu-Chek Inform II system includes a base unit, test strips, control solutions, and a USB cable for connectivity. The base unit houses the meter and facilitates data management. Test strips are used for blood glucose measurement and must be handled according to the manual. Control solutions ensure meter accuracy and are applied during calibration. Additional components may include a quick reference guide and operator manual. The system is designed for clinical use, with the base unit connecting to a PC for data transfer. Ensure all components are stored properly and used as per instructions to maintain functionality and accuracy.
Getting Started with the Accu-Chek Inform II
Unpack and inspect the system. Read the operator manual thoroughly. Power on the base unit and ensure all components are connected properly before first use.
- Charge the base unit if necessary.
- Insert a test strip to initialize the meter.
- Familiarize yourself with the display and controls.
2.1 Preparing the System for First-Time Use
To prepare the Accu-Chek Inform II system, first unpack and inspect all components for damage. Connect the base unit to a power source using the provided adapter and ensure all cables are securely attached. Power on the system and follow the on-screen instructions for initial setup. Insert a test strip to initialize the meter and allow the system to perform its self-test. Once initialized, set the date, time, and any required institutional settings. Finally, perform a quality control check using a known test strip to ensure accuracy before patient use.
2.2 Connecting the Base Unit to a PC
To connect the Accu-Chek Inform II Base Unit to a PC, use the provided USB cable. Insert one end into the USB port on the base unit and the other into the PC. Ensure the PC has the necessary drivers installed for recognition. Once connected, the system may automatically detect the device. If not, refer to the operator manual for driver installation instructions. This connection allows access to the operator manual, stored as a PDF file, and enables software updates or data transfer. For older hardware, consult Appendix E of the manual for specific connection instructions.
Operating the Accu-Chek Inform II
Power on the meter, insert a test strip, and perform a self-test. Obtain a blood sample, apply it to the strip, and wait for the result display.
3.1 Performing a Patient Test
Turn on the Accu-Chek Inform II meter and insert a test strip, ensuring it clicks into place. Perform a self-test by pressing the power button. Obtain a blood sample via fingertip puncture, applying it to the designated area on the strip. The meter will automatically detect the sample and display the result within seconds. Ensure proper handling and safety, using a new strip for each test to avoid contamination. Follow infection control guidelines for multiple patient use. Store used strips securely and dispose of them appropriately. Always refer to the manual for detailed instructions and troubleshooting tips.
3.2 Understanding the Meter’s Display and Alerts
The Accu-Chek Inform II meter features a clear LCD display showing blood glucose readings, date, time, and battery status. Alerts include “LO” for low readings (below 10 mg/dL) and “HI” for high readings (above 600 mg/dL). Error codes like “E1,” “E2,” or “E3” indicate issues such as expired or damaged test strips. The meter also prompts for quality control checks or meter verification. Audio signals sound for errors or completed tests. Understanding these alerts ensures accurate results and proper troubleshooting. Always refer to the manual for detailed explanations of codes and solutions to maintain optimal system performance and patient care.
Maintenance and Troubleshooting
Regular maintenance includes cleaning the meter, checking strip expiration dates, and addressing error messages. Troubleshooting involves resolving common issues promptly for optimal performance.
4.1 Regular Maintenance and Care
Regular maintenance is crucial for the Accu-Chek Inform II system to ensure accurate results and longevity. Clean the meter with a soft, dry cloth and avoid harsh chemicals. Check battery levels and replace them as needed. Store test strips in a cool, dry place and use them before their expiration date. Properly dispose of used strips and lancets; Refer to the operator manual for detailed cleaning instructions and maintenance schedules to keep the device functioning optimally.
4.2 Common Error Messages and Solutions
The Accu-Chek Inform II may display error messages such as “HI” or “LO,” indicating blood glucose levels outside the meter’s range. These require immediate medical attention. Error codes like “E1” or “E2” often relate to system malfunctions. For “HI,” retest with a new strip, ensuring proper calibration. For “LO,” check strip expiration and meter synchronization. If issues persist, refer to the operator manual or contact Roche support. Regularly updating software and using compatible accessories can prevent errors. Always follow troubleshooting steps in the manual to resolve issues quickly and ensure accurate results.
Regulatory Information and Compliance
The Accu-Chek Inform II is FDA-cleared and CE-marked, ensuring compliance with international medical device standards. It meets regulatory requirements for safety and performance in professional settings.
5.1 FDA Clearance and CE Marking
The Accu-Chek Inform II system has received FDA clearance in the U.S. and is CE-marked for distribution in European markets. These regulatory approvals confirm that the system meets strict safety and performance standards for medical devices. The FDA clearance ensures the device is safe and effective for its intended use in clinical settings, while the CE marking signifies compliance with European Union health, safety, and environmental requirements. Both designations underscore the system’s reliability for healthcare professionals to measure blood glucose levels accurately in professional settings, adhering to global medical device regulations and providing assurance of quality and efficacy.
5.2 Compatibility with Other Medical Devices
The Accu-Chek Inform II system is designed to integrate seamlessly with other medical devices, ensuring comprehensive patient care. It is compatible with Roche diagnostic systems such as cobas and CoaguChek, allowing for streamlined data management. The system supports connectivity to hospital information systems (HIS) and electronic medical records (EMRs), facilitating efficient workflow. Data can be transferred via USB or through wireless connectivity options, enhancing interoperability. This compatibility ensures that healthcare professionals can access accurate and reliable glucose monitoring data alongside other critical patient information, supporting informed decision-making and improving patient outcomes in clinical settings.
References and Additional Resources
Access the full operator manual as a PDF via the Roche website or by connecting the base unit to a PC. Contact Roche Diagnostics Support for further assistance.
6.1 Accessing the Full Operator Manual
To access the full operator manual for the Accu-Chek Inform II, connect the base unit to a PC using the provided USB cable. The manual is stored as a PDF file on the base unit. Once connected, navigate to the device’s storage folder to locate and open the manual. Additionally, the manual can be downloaded from the Roche Diagnostics website at this link. The manual provides detailed instructions for system operation, maintenance, and troubleshooting, ensuring comprehensive guidance for healthcare professionals.
6.2 Contacting Roche Diagnostics Support
For assistance with the Accu-Chek Inform II system, contact Roche Diagnostics Support. Refer to the operator manual or the Roche website for contact details. Support is available to address technical issues, troubleshooting, and maintenance inquiries. Ensure to have the system’s serial number and specific error messages ready for efficient assistance. Roche’s customer service provides comprehensive support to healthcare professionals, ensuring optimal use of the Accu-Chek Inform II for accurate blood glucose monitoring. Visit this link for more information or to access support resources directly.