Cholestech LDX - User Manual

< TABLE OF CONTENTS
System
Procedure Manual

Summary

1.0 Setup and Maintenance

1.2 Cholestech LDX Optics Check Cassette

A Cholestech LDX Optics Check Cassette with known reflectance values is supplied with each Analyzer.

1.3 Optics Check Cassette Test Procedure

Procedure for running an optics check using the Cholestech LDX Optics Check Cassette.

1.7 Cholestech LDX System Initial Setup

Assures environmental conditions are met and the system runs properly during initial setup.

1.8 Maintenance and Cleaning of the Cholestech LDX System

Procedure for routine cleaning of the Cholestech LDX Analyzer case and cassette drawer.

1.9 Course of Action If System Becomes Inoperable

Steps to follow if the Cholestech LDX System becomes inoperable.

2.0 Specimen Collection and Handling

2.2 Fingerstick Procedure

Detailed procedure for collecting a capillary blood sample via fingerstick.

2.4 Venipuncture Procedure

Procedure for collecting venous blood samples by a qualified phlebotomist.

2.6 Reporting Results Properly

2.8 Proper Specimen Storage

Guidelines for storing serum and plasma samples to maintain analyte stability.

3.0 Quality Control

3.2 Quality Control Materials

Discusses preferred and alternate quality control materials for the Cholestech LDX System.

3.3 Frequency of Testing

Specifies when quality control samples must be tested according to CLIA and regulations.

3.4 Establishing and Calculating a Control Range

Procedure for establishing and calculating acceptable control ranges for analytes.

3.6 When Results Are Outside Acceptable Control Limits

Procedure to follow when quality control results fall outside established ranges.

3.7 Quality Control Remedial Action

3.11 Cholestech LDX System Calibration Verification and Linearity Testing

Procedure for verifying calibration and linearity of the Cholestech LDX System.

4.0 Safety

4.1 Introduction

Discusses OSHA regulations for protecting workers from bloodborne pathogens.

5.0 Training

5.2 Cholestech LDX Training Checklist

6.0 Material Safety Data Sheets

6.1 Material Safety Data Sheets

7.0 Proficiency Testing

7.1 Overview of Proficiency Testing

Discusses the importance, necessity, and process of proficiency testing.

7.2 Proficiency Testing Agencies

9.0 Master Forms

Optics Check Log

Instrument History Record

Information and Service Log

Initial Setup Checklist

Checklist to ensure proper initial setup of the Cholestech LDX System.

Equipment Maintenance; Cleaning Log

Patient Result Log

Quality Control Log

Log for recording quality control data, including lot numbers and results.

Quality Assurance Record

Record for documenting quality assurance activities and control results.

Control Range Calculation Form

Form for calculating acceptable control ranges for analytes.

Accuracy Study Data

Precision Calculation Form (Within-Run)

Training Checklist

Cholestech LDX Specifications

General

Sample Type	Whole blood, serum, plasma
Test Time	5 minutes
Power Requirements	100-240V AC, 50-60 Hz
Sample Volume	40 μL
Power Supply	AC adapter or battery
Weight	1.0 kg
Reportable Results	Cholesterol, HDL, LDL, triglycerides, glucose
Calibration	Factory calibrated
Connectivity	RS-232 serial port
Dimensions	6.0 in x 9.5 in x 4.5 in (15.2 cm x 24.1 cm x 11.4 cm)