Nova StatStrip - User Manual

Nova StatStrip

Glucometer Quick Reference Guides
Purpose:
This procedure provides one-page quick reference guides for several basic operations involving
the Nova StatStrip

Glucose Hospital Meter System. This is intended to help users get access
to easy-to-follow job aides and process charts.
While the information in these quick reference guides are accurate, the materials are presented
in a generalized and outlined format. Thus, staff are encouraged to always refer to the detailed
and complete versions of these procedures.
Safety Precautions:
1. Universal Safety Precautions should be adhered to when handling or using the
StatStrip

Glucose Meter System to reduce the risk of disease transmission. All parts of
the StatStrip

Glucose Hospital Meter System are considered potentially infectious and
can potentially transmit blood-borne pathogens between patients and healthcare
professionals.
2. Always wear a new pair of protective gloves before testing each new patient.
3. Only utilize single-use lancing devices. Do not re-use lancets.
4. Follow all operating instructions. Do not attempt to operate any equipment unless
training has been successfully completed
Quick Reference Guide Detailed Operating Procedure
QC Test
Performing a QC Test on the Nova StatStrip

Glucometer
Patient or Proficiency Test
Performing a Patient or Proficiency Test on
the Nova StatStrip

Glucometer
Newborn Heel Puncture
Performing Heel Puncture Collection for
Whole Blood POC Glucose Determination
Provincial Health Services Authority
Nova StatStrip Glucometer Quick Reference Guides
Identifier: CWPC GLU 0220 Version #: 2.1
Folder: CW POCT Type: Procedure (3yr)
Subfolder: WB GLUCOSE Effective on: 2021-06-15
Page 1 of 5
Documents used outside of OMNI are uncontrolled.
Renewed on: 2021-06-15 Revision Date: 2024-06-15
Renewed by: Calvin Lee Approved on: 2021-06-15
Reviewed on: 2021-06-15 Approved by (name): Li Wang
Reviewed by: Julieto C. Tumulak
Written by: Julieto C. Tumulak Approved by (sign.):

Summary

QC Test Procedure

Login and Operator ID Entry

Log in to the meter and enter operator identification for QC testing.

Initiate QC Test and Scan Strip

Access the QC function and scan the glucose test strip barcode.

Apply QC Sample to Strip

Scan the QC bottle, insert the strip, and apply the QC sample to the strip.

View and Accept QC Result

Review the QC test result and accept it if within the acceptable range.

Troubleshooting QC Failures

Guidance on troubleshooting when QC test results fail, including meter usage suspension.

Patient or Proficiency Test Procedure

Login and Operator ID Entry

Log in to the meter and enter operator identification for patient testing.

Initiate Patient Test and Scan Strip

Access the patient test function and scan the glucose test strip barcode.

Enter Patient or Proficiency ID

Input patient identification or CAP number for proficiency testing.

Apply Blood Sample to Strip

Collect and apply blood sample to the test strip, ensuring proper technique.

Accept, Reject, or Review Patient Result

Manage patient test results by accepting, rejecting, or reviewing.

Newborn Heel Puncture Procedure

Pre-Collection Preparations and Site Selection

Adhere to safety, verify ID, warm site, prepare meter, and select appropriate puncture site.

Perform Heel Puncture

Use a lancet to puncture the skin at the selected site.

Apply Blood Sample to Strip

Apply blood from the heel or micro-collection pipette to the test strip.

Manage Bleeding and Dispose Materials

Apply pressure to stop bleeding and dispose of used materials correctly.

Glucose Reference and Critical Result Handling

Understand glucose ranges and protocols for critical low/high results.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Nova StatStrip® Glucometer is a portable, handheld device designed for rapid and accurate measurement of blood glucose levels in a hospital setting. It is part of the Nova StatStrip® Glucose Hospital Meter System, which is intended to provide quick reference guides for basic operations, helping healthcare professionals access easy-to-follow job aids and process charts for various testing procedures.

Function Description

The primary function of the Nova StatStrip® Glucometer is to measure glucose concentrations in whole blood samples. It is designed for Point-of-Care (POC) testing, allowing for immediate results to aid in patient management. The device supports three main types of tests: Quality Control (QC) tests, Patient tests (including proficiency tests), and Newborn Heel Puncture collections for whole blood POC glucose determination.

For Quality Control (QC) tests, the glucometer guides the user through a series of steps to ensure the device is functioning correctly and providing accurate results. This involves logging in, entering an operator ID, selecting the QC test option, scanning a glucose test strip barcode, scanning a QC bottle, inserting a test strip into the meter, applying a QC drop to the strip, and then reviewing the result. The system is designed to display the result within six seconds. The QC process is crucial for maintaining the reliability of patient results.

For Patient or Proficiency Tests, the glucometer facilitates the measurement of a patient's blood glucose or a proficiency sample. The workflow is similar to QC testing, starting with login and operator ID entry, then selecting the patient test option, scanning the glucose test strip barcode, entering a patient ID (or CAP number for proficiency tests), inserting the test strip, collecting a blood sample (typically after wiping off the first drop of blood), applying the sample to the test strip, and finally reviewing the result. The device is designed to provide results within six seconds.

For Newborn Heel Puncture Collection for Whole Blood POC Glucose Determination, the glucometer is used in conjunction with a heel puncture procedure. This involves preparing the collection site, performing the heel puncture, applying the blood sample to the test strip, and obtaining a glucose reading. This specific application highlights the device's utility in neonatal care, where rapid glucose assessment is often critical.

The device is designed to be user-friendly, with a clear display and intuitive navigation through its menu options. It provides step-by-step instructions on the screen, guiding the user through each phase of the testing process, from login to result review.

Usage Features

The Nova StatStrip® Glucometer incorporates several features to enhance its usability and ensure safe, accurate testing in a clinical environment:

• Guided Workflow: The device provides a clear, step-by-step guided workflow for each type of test (QC, Patient, Newborn Heel Puncture). This minimizes user error and ensures consistency in testing procedures.
• Operator ID and Patient ID Entry: Users are required to enter an Operator ID for accountability and a Patient ID for proper patient record linkage. For proficiency tests, a CAP number can be entered.
• Barcode Scanning: The device supports barcode scanning for glucose test strips and QC bottles, which helps in accurate identification and reduces manual data entry errors.
• Rapid Results: The glucometer is designed to provide blood glucose results within six seconds, which is critical for timely patient management, especially in emergency situations or for rapid assessment of critical glucose levels.
• Sample Application Guidance: The device provides instructions for proper sample application, emphasizing continuous dose application to prevent "flow errors" and ensuring the user maintains contact until a beep sound is heard, indicating sufficient sample.
• Critical Result Handling: The system outlines specific protocols for handling critical low or high glucose results. This includes verifying sample quality, notifying the responsible physician immediately, and confirming results with lab-drawn glucose tests if indicated. This feature underscores the device's role in patient safety.
• Memory Function: The device includes a memory function to store previous results, allowing for review of past tests.
• Battery Indicator: A battery indicator is present to inform the user about the device's power status, ensuring it is adequately charged for use.
• User Interface: The interface includes options for Review, Login, Setup, Accept, Logout, Clear, Scan, and ABC... for alphanumeric input, making it comprehensive yet easy to navigate.
• Adaptability for Neonatal Use: For infants, especially those in incubators, the device supports the use of micro-collection pipettes for sample application, demonstrating its versatility across different patient populations.

Maintenance Features

While the manual primarily focuses on operational procedures, it implicitly highlights several aspects related to the maintenance and reliability of the Nova StatStrip® Glucometer:

• Quality Control (QC) Testing: Regular QC testing is a fundamental maintenance feature. The device guides users through performing QC tests with specific QC levels (e.g., Level 1, Level 2) to verify its accuracy and precision. This ensures that the meter is consistently providing reliable results.
• Troubleshooting for QC Failures: The manual provides clear troubleshooting steps for when QC tests fail. This includes checking if the tested QC level matches the scanned one, verifying the expiry dates of strips and QC solutions, ensuring the first QC drop was discarded, and confirming the QC bottle was mixed well. This systematic approach helps users identify and resolve common issues without requiring immediate technical support.
• Out-of-Service Protocol: If QC failures persist after troubleshooting, the protocol dictates that the meter should not be used and a Point of Care Service Requisition form should be filled out and sent with the meter to the POCT Lab. This ensures that faulty devices are promptly removed from service and properly addressed by qualified personnel, preventing inaccurate patient results.
• Storage and Expiry Management: The manual specifies the shelf life of QC bottles and test strips once opened (3 months for QC bottles, 6 months for test strips). This information is crucial for inventory management and ensuring that only in-date consumables are used, which directly impacts the accuracy of results.
• Safety Precautions: Adherence to universal safety precautions, such as wearing new protective gloves for each patient and using single-use lancing devices, is emphasized. While not direct device maintenance, these practices are essential for maintaining a safe testing environment and preventing contamination, which indirectly contributes to the longevity and proper functioning of the device by minimizing exposure to biological hazards.
• Training Requirement: The manual states that users should not attempt to operate any equipment unless training has been successfully completed. This highlights the importance of proper user education as a preventative measure against misuse and potential damage to the device, contributing to its overall maintenance and operational integrity.

In summary, the Nova StatStrip® Glucometer is a robust and user-friendly device designed for critical glucose monitoring in healthcare settings, emphasizing accuracy, safety, and ease of use through its guided workflows and integrated quality control measures.

Nova StatStrip Specifications