Acon Mission Manuale utente

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Mission®Cholesterol Monitoring System

Important Safety Instructions

If the meter is powered by AC adapter, unplug the equipment

immediately after use.

Misuse of electrical equipment can cause electrocution, burns,

fire and other hazards.

Do not place the equipment in liquid, nor put it where it could fall

into liquid. If the equipment becomes wet, unplug it before

touching it.

If the meter is powered by AC adapter, do not leave the equipment

unattended while it is plugged in.

Use the equipment only for the purpose described in the

instructions for use.

Do not use accessories which are not supplied or recommended

by the manufacturer.

Do not use the equipment if it is not working properly or if it has

suffered any damage.

Do not let the equipment or its flexible cord come into contact

with surfaces which are too hot to touch.

Do not use the equipment where aerosol sprays are being used or

where oxygen is being administered.

Do not use the equipment in direct sun.

Keep these instructions.

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Table of Contents

Section 1 Introduction ...........................................................................1

Section 2 Getting Started ......................................................................2

Section 3 Components ..........................................................................4

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

Test Devices............................................................................................. 7

Control Devices........................................................................................ 9

Control Solution...................................................................................... 10

Section 4 Initial Setup..........................................................................13

Turn on Meter......................................................................................... 13

Coding the Meter.................................................................................... 13

Section 5 Meter Setup and Options....................................................15

Test Number Setup ................................................................................ 15

System Setup......................................................................................... 16

Section 6 Testing .................................................................................22

Specimen Collection............................................................................... 22

Test Processing...................................................................................... 28

Section 7 Coronary Heart Disease (CHD) Risk Evaluation...............31

Section 8 Data/Communication ..........................................................38

Data Transmission ................................................................................. 38

Deleting Data ......................................................................................... 38

Memory/Database.................................................................................. 39

Section 9 Optical System Check ........................................................41

Section 10 Quality Control ..................................................................43

Control Solution Testing ......................................................................... 43

Interpreting Results ................................................................................ 45

Section 11 Maintenance ......................................................................46

General Cleaning ................................................................................... 46

Disinfection Process............................................................................... 47

Replacing the Batteries .......................................................................... 48

Section 12 Precautions........................................................................49

Section 13 Troubleshooting................................................................50

Appendix 1 Meter Specifications........................................................52

Appendix 2 Index of Symbols .............................................................53

Appendix 3 Warranty ...........................................................................54

Section 1 Introduction

The Mission®Cholesterol Monitoring System is intended for the quantitative

determination of Total Cholesterol (CHOL), High-Density Lipoprotein

Cholesterol (HDL), Triglycerides (TRIG), calculated Low-Density Lipoprotein

Cholesterol (LDL), and the calculated ratio of CHOL/HDL in capillary and

venous human whole blood, plasma, and serum. Professionals can also

evaluate a patient’s 10-year risk of Coronary Heart Disease with this system.

The easy-to-operate system consists of a portable meter that analyzes the

intensity and color of light reflected from the reagent area of a test device,

ensuring quick and accurate results.

The Mission®Cholesterol Monitoring System provides results in less than 2

minutes. The meter can store up to 200 results and records can be

transferred to a computer for further analysis using the USB port. The meter

can be operated with 4 AAA (1.5V) batteries or an optional AC adapter.

To ensure accurate results:

Read instructions carefully and complete any necessary training before

use.

Use the code chip that is included in each box of test devices.

Only use the Mission®Cholesterol Test Devices with the Mission®

Cholesterol Meter.

For in vitro diagnostic use only. Your blood cholesterol monitoring

system is only to be used outside the body for testing purposes.

For self-testing and professional use.

For professional use: Fresh capillary blood, heparinized or EDTA

venous whole blood, serum and heparinized plasma can be tested. For

self-testing use: Only test fresh capillary blood from the fingertip.

For self-testing, consult your physician or healthcare professional

before making any adjustments to your medication, diet or activity

routines.

Keep out of reach of children.

Note: Throughout this User’s Manual, meter parts or functions will

appear in bold. Items appearing on displays are identified in

bold italics.

Section 2 Getting Started

Before testing, read the instructions carefully and learn about all the

components of the Mission®Cholesterol Monitoring System. Depending on

the package type, some of the components may need to be purchased

separately. Please check the list of contents on the outer box for details on

which components are included with your purchase. The following items are

needed to perform a test:

Cholesterol Meter

AAA Batteries

Lancing Device

Capillary Transfer Tube/Dropper

Safety Lancet

Sterile Lancets

Test Device Control Device

Front Back Front Back

Code Chip

Carrying Case

Control Solution

Cholesterol Meter: Reads the test devices and displays the concentrations

of CHOL, HDL, TRIG, and calculated LDL and CHOL/HDL values.

Test Devices: Part of the system, these are inserted into the meter to

measure the concentrations of CHOL, HDL, and TRIG, from which LDL and

the CHOL/HDL ratio are calculated.

Code Chip: Automatically calibrates the meter with the code number when

inserted into the meter.

Capillary Transfer Tubes/Droppers: Collects capillary blood from fingertip

blood testing for accurate results (10µL for an individual test and 35µL for a

3-in-1 test).

Capillary Transfer Tubes Insert: Provides detailed instructions on using

the Capillary Transfer Tubes.

AAA Batteries: Provides power for the meter.

Carrying Case: Provides portability for testing.

User’s Manual: Provides detailed instructions on using the Cholesterol

Monitoring System.

Quick Reference Guide: Provides a brief overview of the Cholesterol

Monitoring System and its testing procedures.

Test Devices Package Insert: Provides detailed instructions on using the

Cholesterol Test Devices.

Lancing Device: Used with sterile lancets to prick the fingertip for blood

specimen collection. The packaged lancing device has multiple depth

settings, allowing users to adjust the depth of the puncture and minimize

discomfort. It can also eject the used lancets.

Lancing Device Package Insert: Provides detailed instructions on how to

use the lancing device.

Sterile Lancets: Used with the lancing device to draw blood specimens for

individual tests. Sterile lancets are inserted into the lancing device for each

blood draw and discarded after use.

Safety Lancets: Used to draw blood specimens for the 3-in-1 test and

individual tests. Discard after use.

Control Device: Verifies the proper operation of the meter by checking that

the meter can detect a pre-calibrated value.

Control Device Package Insert: Provides detailed instructions on how to

use the Control Devices.

Control Solution: Verifies that the test is being performed correctly and

validates that the test device and meter are working together properly.

Warranty Card: Card included in the package, which should be completed

and returned to the distributor to qualify for the 2-year meter warranty.

Section 3 Components

The Mission®Cholesterol Meter reads the test devices and displays the

concentrations of CHOL, HDL, TRIG, the calculated value of LDL and the

ratio of CHOL/HDL. Use the below diagram to become familiar with all the

parts of the meter.

Meter

1 USB Port 7 Device Channel

2 Liquid Crystal Display (LCD) 8 Test Device Holder

3 Code Chip 9 Position Arrows

4 Right Arrow Button ►10 Code Chip Slot

5 On/Off Button 11 Battery Cover

6 Left Arrow Button ◄

Meter Display

During testing, the Mission®Cholesterol Meter will display icons showing the

status, options available, and prompts for testing:

1 Battery Icon 8 Memory Indicator

2 Sound Icon 9 Code

3 Date 10 Measurement Units

4 Test Number 11 Te s t I t e m

5 Blood Drop Symbol 12 Systolic Blood Pressure

6 Test Result Area 13 Yes/No Option

7 Test Device Symbol 14 Options for Gender, Smoker

or Non-smoker, and MI

Battery Icon: Appears when the battery should be replaced.

Sound Icon: Appears when the sound is turned on.

Date: Shows the current date or date tested.

Test Number: Indicates the specimen type and assigned test number.

Test Result Area: Displays the test result or menu options.

Memory Indicator (MEM): Appears when a test result is being recalled

from memory.

Code: Shows the code number of the test devices.

Measurement Units: Displays the measurement units of the test result.

Test Device and Blood Drop Symbols: Indicate when to insert test device

or apply specimen.

Test Item: Shows which item is being tested.

Systolic Blood Pressure: Needed for CHD risk analysis. Calculated CHD is

for professional use only.

Yes/No Option: Displays answer to yes/no questions during CHD risk

analysis. Calculated CHD is for professional use only.

Options for Gender, Smoker or Non-smoker, and MI: Displays answers to

questions regarding gender, smoking status and history of heart attack (MI).

Calculated CHD is for professional use only.

Meter Use and Precautions

Do not get water or other liquids on or inside the meter.

Keep the Device Channel clean.

Keep the meter dry and avoid exposing it to extreme temperatures and

humidity.

Do not drop the meter or get it wet. If the meter is dropped in water or

becomes wet, ensure the meter is working properly by running an

Optical Check. Refer to Optical System Check for details.

Do not take the meter apart. Taking the meter apart will void the

warranty.

Refer to Maintenance for details on cleaning the meter.

Keep the meter and all associated parts out of the reach of children.

Note: Follow proper precautions and all local regulations when

disposing of the meter and used batteries.

All EMC Preventative Warnings for the Cholesterol

Monitoring System

1. This instrument is tested for immunity to electrostatic discharge as

specified in IEC 61000-4-2. However, use of this instrument in a dry

environment, especially if synthetic materials are present (synthetic

clothing, carpets, etc.) may cause damaging static discharges that

may cause erroneous results.

2. This instrument complies with the emission and immunity

requirements described in EN 61326-1 and EN 61326-2-6. Do not

use this instrument in close proximity to sources of strong

electromagnetic radiation, as these may interfere with proper

operation of the meter.

3. For professional use, the electromagnetic environment should be

evaluated prior to operation of this device.

Test Devices

The Mission®Cholesterol Test Devices are plastic devices that work with the

Mission®Cholesterol Meter to measure the lipid concentration in whole blood,

plasma and serum.

Test device appears as shown below:

The following test devices are currently available for use with the Mission®

Cholesterol Meter:

3-in-1 Lipid Panel

Total cholesterol (CHOL) individual test device

High-Density Lipoprotein (HDL) individual test device

Triglyceride (TRIG) individual test device

The 3-in-1 Lipid Panel can detect CHOL, HDL and TRIG with one device

simultaneously. Calculated LDL and the ratio of CHOL/HDL can also be

calculated by the meter at the same time.

Insert Arrow: Located on the front of the test device, the arrows indicate the

direction in which the test device should be inserted into the meter.

Specimen Application Area: After the test device is inserted into the Device

Channel, apply the correct specimen volume (10µL for individual test devices

or 35µL for 3-in-1 test devices) to the region in the center of the test device.

Handle: Located on the end of the test device, the handle is used to insert

and remove the test device from the meter.

Test Area: Located on the back of the test device. The meter will detect and

read this area to give results of lipid levels.

Position Arrows:Located in the middle of the specimen application area (of

the test device). When a test device is inserted, the two arrows should be

parallel with the two arrows on the meter holder to make sure the test device is

inserted correctly.

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