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NOVA BIOMEDICAL StatStrip 55848 - User Manual

NOVA BIOMEDICAL StatStrip 55848
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Glucose Hospital Meter System
Instructions for
Use Manual
55848
Onl
y
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1 9/13/18 8:29 AM

Table of Contents

Questions and Answers

Summary

NOVA BIOMEDICAL SYMBOL DIRECTORY

1 Introduction

1.1 About This Manual

Manual for StatStrip Glucose Hospital Meter System from Nova Biomedical.

1.2 Important Safety Instructions

Crucial safety guidelines for operating the StatStrip Glucose Hospital Meter System.

1.3 Intended Use

Describes the system's purpose for quantitative glucose determination in various blood samples.

1.4 Capillary Precautions

Cautionary advice for testing capillary whole blood, noting potential variability.

1.5 Limitations

Details limitations of the system, including specimen types and environmental conditions.

1.6 General Precautions

General safety advice for operating the meter and handling test strips.

1.7 The Sample

Specifies acceptable sample types for testing, including capillary and venous whole blood.

1.8 Interfering Substances

Lists drugs and physiological conditions that do not interfere with results.

1.9 Operation Overview

Explains the meter's interface, keypad, and basic operation.

1.10 Installing the StatStrip Glucose Hospital Meter

Instructions for installing the battery and placing the meter on the charging station.

1.11 Operator Login

Process for operators to log into the meter to access functions.

1.12 Administration (Admin) Screen

Describes non-patient functions accessible via the Admin screen.

1.13 Assign Location

Procedure for assigning or changing the meter's location.

1.14 Meter Transport Case

Details the components that can be stored in the meter's transport case.

4 Docking;Charging Station

5 Linearity Test

5.1 Running a Linearity Test

Step-by-step guide to performing a linearity test using the StatStrip Glucose Hospital Meter.

6 Maintenance

6.1 Charging the Meter

Instructions on how to charge the meter when the battery is low.

6.2 Changing the Battery

Procedure for replacing the meter's rechargeable battery.

6.3 Cleaning and Disinfecting the Meter

Detailed steps for cleaning and disinfecting the meter after use.

7 Troubleshooting

7.1 Meter Screen Alerts

Explains various alerts displayed on the meter screen and their meanings.

A Appendix

A.1 StatStrip Glucose Hospital Meter Specifications

Technical specifications of the StatStrip Glucose Hospital Meter.

A.2 Controls;Linearity Solutions

Information on the solutions required for QC and linearity testing with the meter.

A.3 Barcode Scanner

Details about the meter's 2D barcode scanner and supported formats.

A.4 Normal Glucose Adult Values Non-diabetic

Provides reference values for non-diabetic adults, for guidance only.

A.5 Ordering Information

Lists supplies and parts for the StatStrip Glucose Hospital Meter.

A.6 Theory

Explains the methodology behind glucose measurement.

A.7 Results of Multi-Center Clinical Study: Patients Requiring Intensive Medical Intervention;Therapy

Presents results from a clinical study on patients needing intensive medical care.

A.9 Wireless Meter Use

Information regarding the wireless meter option and network connectivity.

A.10 Warranty

Outlines the warranty terms and conditions for the StatStrip Glucose Hospital Meter.

NOVA BIOMEDICAL StatStrip 55848 Specifications

General IconGeneral
Product NameStatStrip
Model Number55848
CategoryMeasuring Instruments
TypeGlucose Meter
Sample TypeWhole blood
Test Time6 seconds
Data StorageYes
DisplayLCD
ConnectivityUSB
Sample Volume0.6 μL
Memory Capacity1000 results
Power SourceBattery
Operating Temperature10 to 40 °C
Operating Humidity10% to 90% relative humidity, non-condensing
Weight220 g (0.49 lb)

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