IMMULITE / IMMULITE 1000

Maintenance Protocol
System
Preventive Maintenance Protocol

Customer:

Address:

Fax / E-Mail:
Fax / E-Mail:

Department: Room:
Material-No.: Serial-No.:
Contract-No.: Expire date:
Order-No.: System - ID:

The instructions DCIM-B01.831.01.03.XX are required for this protocol

2 Protocol Date: Serial-No.:

Evaluating the Condition of the System

The system has no deficiencies. *
The system has slight deficiencies that have no effect on contin‐
ued operation of the system. The deficiencies should be corrected
preventively. *
The system has serious deficiencies. For safety reasons, continued
operation of the system is permitted only after successfully cor‐
recting the deficiencies.

*) For imaging systems: The result of the image quality check shows no deviation from
the reference values.

The evaluation was performed after completing all work steps.

Signature:

Date: Name:

If required by country-specific regulations:

The customer or a representative has taken note of the result of the evaluation of the
system condition.

Signature:

Date: Name:

Remarks:

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Protocol Date: Serial-No.: 3

Remarks Regarding the Protocol

The chapter numbers refer to the chapters in the instruction, which is referenced on the
cover page.
All pages have to have the serial number of the system and the date of maintenance in
the page header.
The assignment n.a. (not applicable) indicates that the checkpoint or measured value is
not used for this system.
On page 2 the completeness and the results of the maintenance work is confirmed.

Explanation of Abbreviations in the Protocol

Abbrev. Explanation Abbrev. Explanation

SI Safety Inspection PMF Preventive Maintenance, Operating
Value Check, Function Check
SIE Electrical Safety Inspection Q System Quality, Image Quality
SIM Mechanical Safety Inspec‐ QIQ Image Quality
tion
PM Preventive Maintenance QSQ System Quality Check
PMP Periodic Preventive Mainte‐ SW Software Maintenance
nance
PMA Preventive Maintenance Ad‐ CSE Customer Service Engineer
justments

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4 Protocol Date: Serial-No.:

Measuring Equipment and Measuring Instruments Used

Measuring instruments and measuring devices (phantoms, MR coils, etc.) may not be en‐
tered in the table if they have already been entered in the mobile device.

Measuring equipment / -instruments Serial No. Date used

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Protocol Date: Serial-No.: 5
OK not n.a.
OK

1 Overview
1.2 Tools and Materials

2 Maintenance Procedures
2.1 Preliminary Check
2.1.1 Discuss Past Performance with Customer
QSQ Discuss past performance with customer.
2.1.2 Check Error Log
PMP Check Error Log (past 30 days)
2.1.3 Make Necessary Upgrades
PMP Make necessary upgrades
2.1.4 Change Main Fan Filter and Verify Main Fan Operation
PM Change main fan filter and verify main fan operation
2.1.5 Check Universal Power Supply (UPS) Sustains Power
PM Check that UPS sustains power when unplugged

2.2 Power Supply

2.2.1 Check Voltages at the Syringe Interface PCB
PM Check the 24 VDC . The acceptable range is 23.8 to 24.2

Value:

PM Check the 12 VDC voltage. The acceptable range is 11.8 to

12.2
Value:

PM Check the -12 VDC voltage. The acceptable range is -12.2 to

-11.8
Value:

PM Check the 5 VDC voltage. The acceptable range is 4.9 to 5.2

Value:

PM Check the -5 VDC voltage. The acceptable range is -5.2 to

-4.8
Value:
2.2.2 Check if Voltages Are In Range At The PMT Power Supply
PM Check the 15 VDC voltage (IMMULITE Only). The acceptable
range is 14.8 to 15.2/non-inter. PMT
Value:

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6 Protocol Date: Serial-No.:
OK not n.a.
OK

PM Check the 5 VDC voltage. The acceptable range is 4.8 to 5.2

Value:

PM Check the -5 VDC voltage. The acceptable range is -5.2 to

-4.8
Value:
2.2.3 Verify Power Supply Fan Operation
PM Verify power supply fan operation

2.3 Syringe Module

2.3.1 Lubricate lead screws and guide shafts for each dilutor
PM Lubricate lead screws and guide shafts for each dilutor
2.3.2 Inspect or Replace Micro and Macro Valves on Syringe Dilutors
PM Replace non-ceramic micro and macro valves on Hamilton
dilutors
2.3.3 Check Straightness of Syringe “B” Plunger
PM Check straightness of syringe “B” plunger
2.3.4 Replace 5000 µl and 250 µl Syringe Tips
PM Replace 5000 µL and 250 µL syringe tips
2.3.5 Check Operation of V1, V2, and V4
PM Check operation of V1, V2, and V4 with probe tubing/no
probe
2.3.6 Check the Operation of the Micro and Macro Valves
PM Check operation of micro and macro valves

2.4 Pipettor/Reagent Carousel Module

2.4.1 Check X-Pipettor Belt for Wear
PM Check X-pipettor belt for wear
2.4.2 Check Position of X-Pipettor and Z-Pipettor
PM Check Position of X-pipettor and Z-pipettor
2.4.3 Check Operation of Pipettor Level Sensor
PM Check operation of pipettor level sensor
2.4.4 Check Pipettor-Z Lead Screw and Slide Bearing
PM Check pipettor-Z lead screw and slide bearing
2.4.5 Check Operation of Tip-jam Sensor
PM Check operation of tip-jam sensor
2.4.6 Check Reagent Tray Positions (Home and Position)
PM Check reagent tray positions (Home and Position)

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Protocol Date: Serial-No.: 7
OK not n.a.
OK

2.4.7 Check the Probe and Check Dispense

PM Check the probe and check dispense

2.5 Luminometer Module

2.5.1 Lubricate and Check the Upper Shuttle Bearing
PM Remove, lubricate, and check upper shuttle slide bearing
2.5.2 Change Small Idler Wheel Assembly
PM Change small idler wheel assembly
2.5.3 Check the High-speed Spinner O-rings
PM Check high-speed spinner O-rings
2.5.4 Set High-Speed Spinner Speed (5400-5600) RPMs
PM Set high-speed spinner speed (5400 - 5600 RPM)
2.5.5 Check Shuttle Positions and Verify Shuttle Sensor Flag is not Bent
PM Check shuttle positions and verify shuttle flag is not bent
2.5.6 Check for Proper Wash and Spin of Test Unit
PM Check for proper wash and spin of test unit
2.5.7 Check Luminometer Chain Positioning and Tension
PM Check luminometer chain positioning and tension
2.5.8 Check for Slippage Between Lum Chain and Motor Shaft
PM Check for slippage between lum. chain and motor shaft
2.5.9 Check Attenuator Belt for Wear
PM Check attenuator belt for wear
2.5.10 Check Attenuator Sensor Disk for Slippage
PM Check attenuator sensor disk for slippage
2.5.11 PMT: Background Counts and Dark Counts
PM PMT: Background counts

Value:

PM Dark counts:

Value:
2.6 Main Carousel Module
2.6.1 Check Main Carousel Ring Gear Positions
PM Check main carousel gear positions and clean all holes

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8 Protocol Date: Serial-No.:
OK not n.a.
OK

2.7 Load Platform/Sample Tray Module

2.7.1 Disassemble and Clean Assay Tube Roller Assembly
PM Disassemble and clean assay tube roller assembly
2.7.2 Replace Assay Tube Roller O-rings
PM Replace assay tube roller O-rings
2.7.3 Replace Barcode Reader Drive O-ring
PM Replace bar code reader drive O-ring
2.7.4 Set Barcode Reader Speed to 750-790 ms/rev
PM Set bar code reader PCB voltage to -3.0
PM Set bar code reader speed to 750 - 770 ms/rev
2.7.5 Check Operation of Sample/Test Unit Barcode Reader
PM Check operation of sample assay bar code reader
2.7.6 Check Load Chain and star wheel positioning
PM Check load chain and star gear positioning
2.7.7 Check Spacing of Sample Tube Guides
PM Check spacing of sample tube guides
2.7.8 Check Sample Tray Full and Tray Removed Sensor Operation
PM Check sample tray full and tray removed sensor operation
2.7.9 Check Load Chain position sensor for dust accumulation
PM Check load chain position sensor for dust accumulation

2.8 Solenoid or Linear Actuator Substrate and Water Wash Pumps

2.8.1 Check Volume of Substrate and Water Pumps
PM Check volume of substrate and water pumps
2.8.2 Check Drawback of Pumps
PM Check that drawback of pumps is 1/4" (+/- 1/8")

2.9 Substrate Module

2.9.1 Check Manual Prime Button
PM Check manual prime button for function and cracks

2.10 Fluidics
2.10.1 Replace Water and Probe Wash Filters
PM Replace water and probe wash filters
2.10.2 Replace Air Filter in Caps of Water and Wash Containers
PM Replace air filters in caps of water and wash containers

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Protocol Date: Serial-No.: 9
OK not n.a.
OK

2.10.3 Replace waste tubing and check waste path for blockage
PM Replace Waste Tubing and Check Waste Manifold for Block‐
age
2.10.4 Check all Tubes for Kinks and Tighten All Fittings
PM Check all tubing for kinks and tighten all fittings
2.10.5 Decontaminate system and test for contamination
PM Decontaminate System and Test for Contamination
PMF Probe

Value:

PMF Pump

Value:

PMF Substrate

Value:
2.11 Computer Software
2.11.1 Verify Attenuation Factor is Correct
SW Record the CAF:

Value:
2.11.2 Verify PMT Multiplier is Correct
SW Record the Multiplier:

Value:
2.11.3 Check Software Version
SW Record the Software Version:

Value:
2.11.4 Ensure Configuration Table Matches Instrument Serial Number
SW Check Configuration Table Filename Format
2.11.5 Print and Store Configuration Table
SW Print and Store the Configuration Table

2.12 Temperatures
PMF Record Substrate Heater Starting (Ambient) Temperature

Value:

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10 Protocol Date: Serial-No.:
OK not n.a.
OK

PMF Record Substrate Heater Final (Heated) Temperature

Value:

PMF Record Luminometer Temperature:

Value:

PMF Record Main Carousel Temperature:

Value:

PMF Record System Ambient Temperature:

Value:

PMF Record Electrical Ambient Temperature:

Value:
2.13 Final Checkout and Customer Satisfaction
PMA Run Controls (adjust first if necessary)

2.14 Maintenance Performed

PM Maintenance Performed

Work steps of this section were performed by:

Signature:

Date: Name:
3 Changes to Previous Version
3.1 Version 03

3.2 Version 02

3.3 Version 01

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served.

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Print No.: DCIM-B01.832.01.03.02 | Replaces: DCIM-B01.832.01.02.02

Doc. Gen. Date: 07.19 | Language: English
© Siemens Healthineers, 2019