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EM6100 Hematology Analyzer SOP: Step-by-Step Operation & Maintenance Guide

2025-04-22 10:08

Standard Operating Procedure (SOP) – Analyzer Maintenance & Operation

1. Power Requirements

  • A. Grounding:

    • Ensure proper earth grounding before use.

  • B. Fuse & Power Cord:

    • Use only the specified fuse type and provided power cord.

  • C. Voltage Check:

    • Verify input voltage matches analyzer requirements before powering on.

2. Environmental Requirements

  • A. Temperature:

    • Normal range: 15°C – 30°C

    • Operating range: 10°C – 40°C

  • B. Humidity:

    • Normal range: 20% – 85% RH

  • C. Atmospheric Pressure:

    • 70 kPa – 106 kPa

  • D. Workplace Conditions:

    • Free from dust, vibration, contamination, noise, and electrical interference.

    • Avoid strong electromagnetic fields (e.g., brush motors, flickering lights, frequent electrical switching).

    • No direct sunlight, heat sources, or drafts.

    • Well-ventilated area.

  • E. Placement:

    • Use on a stable, level indoor workbench.

    • Connect only to a properly grounded outlet.

3. Pre-Operation Checks

  • A. Reagent Inspection:

    • Check for sufficient volume, turbidity, deterioration, and bent tubing.

  • B. Connections:

    • Verify correct external device and power connections.

4. Startup & Login

  1. Turn on the printer (if connected).

  2. Power on the analyzer.

  3. Enter username and password at the login prompt.

5. Background Check (Automatic on Startup)

  • Acceptable Limits:

    • WBC ≤ 0.2×10⁹/L

    • RBC ≤ 0.02×10¹²/L

    • HGB ≤ 1g/L

    • PLT ≤ 5×10⁹/L

    • HCT ≤ 0.5%

  • If Failed:

    • A second retest occurs automatically.

    • If still failed, an "Abnormal Background" alarm triggers—refer to the Troubleshooting manual.

6. Daily Quality Control (QC)

  • Run QC tests before sample analysis (refer to Chapter 7: QC in the manual).

7. Selecting Work Mode

  • Options:

    • Whole Blood Mode

    • Pre-Diluted Mode

  • Sample Input Methods:

    • Enter all information manually or

    • Input only the Sample ID.

  • Click "OK" to confirm settings.

8. Sample Analysis

Whole Blood Mode

  1. Mix EDTA-anticoagulated sample thoroughly.

  2. Place under the probe and press [Aspirate].

  3. Remove tube after beep; analysis begins automatically.

Pre-Diluted Mode

  1. Click "Dilute" and follow on-screen instructions.

  2. Press [Aspirate] to add 200μL diluent (avoid bubbles).

  3. Add 20μL blood, cap, and mix.

  4. Wait 5 minutes, remix, then aspirate for analysis.

9. Standby Mode

  • Activates after idle time (set in settings).

  • Press [Aspirate] to resume operation.

10. Shutdown Procedure

  1. Click "Shutdown" on the main menu.

  2. The analyzer performs probe cleaning.

  3. At "Confirm" prompt, click "OK" and power off all devices.

  4. Empty and properly dispose of waste containers.

11. Troubleshooting

  • Click the error message (bottom-right of screen) for guidance.

  • Refer to Chapter 11: Troubleshooting in the manual.

12. Regular Maintenance

Daily:

  • Normal shutdown with probe cleaning.

Monthly:

  • Wipe external surfaces and probe wipe block (use 75% alcohol).

Extended Non-Use (>2 Weeks):

  • Perform Pack-up function and power off the analyzer.

This SOP  guide book click to check PDF