FOR-A MD Bedienungsanleitung

Blood Glucose Monitoring System

Owner’s Manual

Operator’s Manual

Dear FORA MD Control System

Owner:

Thank you for choosing FORA MD Control Blood Glucose

Monitoring System. Please use with FORA MD Control Blood

Glucose Test Strips only.

This easy-to-use monitoring system provides fast and accurate

results, including automatic upload of test results to hospital and

laboratory information systems enabling powerful data management.

This monitoring system also reduces risks of operator errors and

allows one hand operation by hospital professionals through simple

steps. Integrated barcode scanning helps reduce the risk of manual

data entry errors as well. There is no subjective calibration procedure

required.

This manual contains important information about the system.

Please read it thoroughly and carefully, and keep it for future

reference. If you have further questions about this system, please

contact the Customer Service Center toll-free at 1-888-307-8188

(7:00 am - 6:00 pm PST, Mon. - Fri.) or visit www.foracare.com.

Version 1.0 2016/01

311-4258400-001

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

Users need to adhere to Standard Precautions when handling

or using this device. All parts of the glucose monitoring system

should be considered potentially infectious and are capable of

transmitting blood-borne pathogens between patients and

healthcare professionals. For more information, refer to

“Guideline for Isolation Precautions: Preventing Transmission

of Infectious Agents in Healthcare Settings 2007”,

http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.ht

ml.

The meter should be disinfected after use on each patient.

This Blood Glucose Monitoring System may only be used for

testing multiple patients when Standard Precautions and the

manufacturer’s disinfection procedures are followed.

Only auto-disabling, single use lancing devices should be used

with this device.

The following basic safety precautions should always be taken.

1. Only the healthcare providers who have trained for this system

should operate.

2. Use the device only for the intended use described in this

manual.

3. Make sure to properly setup the system and pass the training test

before performing any tests.

4. Keep the equipment and its flexible cord away from hot surfaces.

5. Do not use the device if it is not working properly or damaged.

6. Before using this product to test blood glucose, read all

instructions thoroughly and practice the test. Do all quality control

checks as directed.

7. Always wear gloves when performing tests and follow your

facility’s infection control policy and procedures.

8. Please do not use accessories which are not specified by the

manufacturer.

9. The meter should be disinfected after use on each patient.

Please refer to section Taking Care of the Meter & Strips for

cleaning and disinfection procedures.

10. Only auto-disabling, single use lancing devices may be used with

this device.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS

BEFORE YOU BEGIN ............................................................................ 1

Important Information.................................................................... 1

Intended Use ................................................................................ 1

CONTENTS OF SYSTEM ....................................................................... 3

Meter Overview............................................................................. 4

Test Strip....................................................................................... 5

Meter Functions ............................................................................ 6

BEFORE USE ......................................................................................... 7

Battery Setup & Recharge............................................................ 7

Setup Mode .................................................................................. 8

Barcode Scanning Procedure....................................................... 9

Calibration..................................................................................... 9

TRAINING ............................................................................................. 10

CONTROL TEST....................................................................................11

Guidelines for Control Solution Testing........................................11

Control Test Procedure ............................................................... 12

PATIENT TEST ..................................................................................... 15

Collecting Blood Samples........................................................... 16

Patient Test Procedure ............................................................... 18

Results Indicators ....................................................................... 21

MEMORY MODE................................................................................... 22

Reviewing Test Results............................................................... 22

Reviewing Test Results by “All Records”.................................... 23

Reviewing Test Results by “Patient Record”............................... 25

Reviewing Test Results by “Operator Record”............................ 26

Reviewing QC Data .................................................................... 27

Reviewing Proficiency Data ........................................................ 28

TAKING CARE OF THE METER & STRIPS ........................................ 29

Disinfecting Procedures.............................................................. 30

Storage ....................................................................................... 32

ERROR MESSAGES ............................................................................ 34

DETAILED INFORMATION................................................................... 36

Reference Values ....................................................................... 36

Comparing Meter and Laboratory Results.................................. 36

SPECIFICATIONS................................................................................. 38

BEFORE YOU BEGIN

Important Information

Severe dehydration and excessive water loss may cause

readings which are lower than actual values.

Use only fresh blood samples to test patient’s blood glucose.

Using other substances will lead to inaccurate results.

We do not recommend using this product on severely

hypotensive individuals or patients who are in shock. Readings

which are lower than actual values may occur for individuals in a

hyperglycemic-hyperosmolar state, with or without ketosis.

Before you start, there are a few important things to remember.

Before performing patient tests, please read this Operator’s Manual

carefully.

The FORA MD Control Blood Glucose Monitoring System must be

properly set up (configured) before performing patient or quality

control tests. Configurations can be set up on the meter or through

MD Control Management System according to each facility’s

requirements.

You should always wear gloves and follow your facility’s infection

control procedures when handling blood-contaminated items. If you

need help when using the meter or during the testing, please read

this manual carefully. If you still have a question, please contact local

customer service for assistance.

Intended Use

This system is intended for use in the quantitative determination of

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