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Service Manual

Intended Use: This


manual must be used in
conjunction with the
VARIANT™ II Service
Manual

VARIANT ™ II
TURBO
Hemoglobin
Testing
System

January 2004
L70243200
VARIANT ™ II TURBO Hemoglobin Testing System

ii Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Bio-Rad Laboratories
Diagnostic Group
4000 Alfred Nobel Drive
Hercules, California
94547
USA

Technical Assistance Contact Information:


CSD_techsupport@Bio-Rad.com

CAUTION

Please read through and familiarize yourself with the contents of the service manual.

All personnel using the VARIANT ™ II TURBO should wear standard laboratory safety
apparatus. (e.g. safety glasses, laboratory coat and gloves)

All reference material (i.e. standards and controls) and patient samples should be
considered as biohazardous material and must be handled with caution.

Waste material contains sample waste plus reagents: treat and dispose of as directed by
your laboratory safety guidelines or by local ordinance.

TRADEMARKS AND REFERENCES

VARIANT™ II TURBO is a trademark of Bio-Rad Laboratories, Inc.


All other trademarks are the property of their respective companies.

L70243200 Service Manual iii


VARIANT ™ II TURBO Hemoglobin Testing System

iv Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Table of Contents

1 Introduction 1-1
1.1 Introduction...................................................................................................... 1-1
1.2 System Modifications ...................................................................................... 1-2
1.3 Safety Precautions............................................................................................ 1-3
1.3.1 Electrical.............................................................................................................................. 1-3
1.3.2 Mechanical .......................................................................................................................... 1-3
1.3.3 Biohazardous ....................................................................................................................... 1-3
1.3.4 Safety Procedures ................................................................................................................ 1-4

2 Specifications 2-1
2.1 Sampling Station Physical and Electrical Specifications................................. 2-1
2.2 Sampling Station Component Specifications................................................... 2-1
2.2.1 Regulatory Compliance ....................................................................................................... 2-5
2.3 Chromatographic Station Physical and Electrical Specifications.................... 2-6
2.4 Chromatographic Station Component Specifications...................................... 2-6
2.4.1 Regulatory Compliance ..................................................................................................... 2-11
2.5 Minimum Computer Specifications............................................................... 2-12

3 Installation and De-Installation 3-1


3.1 Installation Requirements ................................................................................ 3-1
3.2 Unpacking and Inspection................................................................................ 3-1
3.3 VARIANT II TURBO System Setup .............................................................. 3-3
3.4 De-Installation................................................................................................ 3-12

4 VARIANT II TURBO Service Software 4-1


4.1 Introduction...................................................................................................... 4-1
4.2 VCS Service Software ..................................................................................... 4-2
4.3 VSS Service Software...................................................................................... 4-2
4.3.1 Manual Screen ..................................................................................................................... 4-2
4.3.2 Sensor Status ....................................................................................................................... 4-3
4.3.2.1 Z-Low pos .................................................................................................................. 4-4

L70243200 Service Manual v


VARIANT ™ II TURBO Hemoglobin Testing System

4.3.2.2 Status Screen Details.................................................................................................. 4-4

5 TURBO Procedures 5-1


5.1 VCS Procedures ............................................................................................... 5-1
5.1.1 Column Heater Adjustment ................................................................................................. 5-1
5.1.2 6 and 7 Port Valve Rotor Seal and Stator Replacements ..................................................... 5-2
5.2 VSS Procedures ............................................................................................... 5-3

6 Replacement Procedures 6-1


6.1 VCS Replacements .......................................................................................... 6-1
6.1.1 Column Heater Block Replacement .................................................................................... 6-1
6.2 VSS Replacements........................................................................................... 6-2
6.2.1 Upgraded Tube Hold Down Sensor and Wiring.................................................................. 6-2

7 Maintenance 7-1
7.1 Materials .......................................................................................................... 7-1
7.2 VCS.................................................................................................................. 7-2
7.3 VSS .................................................................................................................. 7-5
7.4 Performance Verification................................................................................. 7-8
7.5 VARIANT II TURBO Maintenance Checklist................................................ 7-8

8 Troubleshooting 8-1
8.1 Chromatography Review ................................................................................. 8-1
8.2 Variant Hemoglobin Chromatography ............................................................ 8-3
8.3 Retention Times ............................................................................................... 8-9
8.4 Area Counts ................................................................................................... 8-13
8.5 Error Codes .................................................................................................... 8-15
8.5.1 VCS Error Codes ............................................................................................................... 8-15
8.5.2 VSS Error Codes ............................................................................................................... 8-18
8.5.3 General Error Codes .......................................................................................................... 8-21
8.6 Self Diagnostics ............................................................................................. 8-22
8.6.1 VCST Self Diagnostic Sequence and Flow Chart ............................................................. 8-22
8.6.2 VSST Self Diagnostics Sequence and Flow Chart ............................................................ 8-24
8.7 Timing Chart.................................................................................................. 8-27
8.8 Detector Troubleshooting .............................................................................. 8-28

vi Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8.8.1 Detector Noise Test ........................................................................................................... 8-30


8.8.1.1 Acceptable Noise Tests ............................................................................................ 8-33
8.8.1.2 Failed Noise Test ..................................................................................................... 8-35
8.8.1.3 Lamp Stabilization ................................................................................................... 8-38

9 Spare Parts 9-1


9.1 TURBO Upgrade Parts .................................................................................... 9-1
9.2 Reliability Parts................................................................................................ 9-4

Appendix A A-1
Fluidic Diagrams ....................................................................................................... A - 1
Table of Contents: ........................................................................................................................... A - 1
VCS Tubing Diagram.................................................................................................................. A - 3
VSS Tubing Diagram .................................................................................................................. A - 5

Appendix B B-1
Mechanical Drawings................................................................................................ B - 1
Table of Contents: ............................................................................................................................B - 1
VCS

V2T Column Cartridge Holder ....................................................................................................B - 3


V2T Column Holder Block and Tubing Coil Assembly ..............................................................B - 5

VSS

Sampling Head Unit .....................................................................................................................B - 7

Appendix C C-1
Electronic Diagrams and Layer Drawings ................................................................ C - 1
Table of Contents: ............................................................................................................................C - 1
VCS

VCST Electric Block....................................................................................................................C - 3

VSS

VSST Electric Block ....................................................................................................................C - 5


VSST Tube Holder Driver PCB 293 ............................................................................................C - 7
VSST Tube Holder Driver PCB 293 (Layer Drawing) ................................................................C - 9
VSST Connection PCB 294-254-1, 294-254-4 and 294-255-7..................................................C - 11

L70243200 Service Manual vii


VARIANT ™ II TURBO Hemoglobin Testing System

VSST XYZ Connect PCB 294-254-1 (Layer Drawing).............................................................C - 13


VSST Z Axis PCB 294-254-4 (Layer Drawing) ........................................................................C - 15
VSST Z Sensor PCB 294-255-7 (Layer Drawing) .....................................................................C - 17
VSST Tube Holder Sensor PCB 295-253-7 and 295-253-8.......................................................C - 19
VSST Tube Holder Sensor PCB 295-253-7-8 (Layer Drawing)...............................................C - 21

viii Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

List of Figures

Number Title Page

Section 1

Figure 1-1 VARIANT II TURBO Hemoglobin Testing System 1-1

Section 3

Figure 3-1 Unpacking the VSS 3-2


Figure 3-2 Unpacking the VCS 3-2
Figure 3-3 HP Compaq D530 Series Computer 3-4
Figure 3-4 Waste Tank Level Sensor 3-4
Figure 3-5 Cartridge Holder 3-6
Figure 3-6 Pump Settings 3-8
Figure 3-7 Configuration Screen 3-10

Section 4

Figure 4-1 New VSS Manual Screen 4-2


Figure 4-2 Warning Message for VARIANT II 4-3
Figure 4-3 Z-Low Position in Sensor Status Screen 4-3
Figure 4-4 Sensor Status Screen for VARIANT II 4-4
Figure 4-5 Sensor Status Details 4-5

Section 5

Figure 5-1 Temperature Probe in Column Heater 5-1


Figure 5-2 Temperature Probe with Door Closed 5-1
Figure 5-3 6 Port Valve Connections 5-2
Figure 5-4 7 Port Valve Connections 5-2

Section 6

Figure 6-1 VSS Tube Hold Down Assembly 6-2


Figure 6-2 VSS Tube Hold Down Assembly Sensor and Wiring
Upgrade Kit 6-3
Figure 6-3 Removal of the Old Sensor Assemblies 6-3
Figure 6-4 Turning the Lead Screw 6-4
Figure 6-5 Installing the Sensor Bracket 6-4
Figure 6-6 Securing the New Sensor Assembly 6-5

L70243200 Service Manual ix


VARIANT ™ II TURBO Hemoglobin Testing System

Figure 6-7 Inserting the Cable at the Connector 6-5


Figure 6-8 Securing the Cable Bracket 6-6
Figure 6-9 Checking the Cable 6-6
Figure 6-10 Installing the New Wiring Assembly 6-7
Figure 6-11 Upgraded Tube Hold Down Assembly 6-7

Section 8

Figure 8-1 Acceptable A1c Chromatogram 8-2


Figure 8-2 Heterozygous Hemoglobin E 8-4
Figure 8-3 Heterozygous Hemoglobin D 8-5
Figure 8-4 Heterozygous Hemoglobin S 8-6
Figure 8-5 Heterozygous Hemoglobin C 8-7
Figure 8-6 Hemoglobin C Carryover 8-8
Figure 8-7 Misidentified A1c Peak 8-9
Figure 8-8 Early Retention Time Flow Chart 8-10
Figure 8-9 Late A1c Retention Time Flow Chart 8-11
Figure 8-10 Late Ao Retention Time Flow Chart 8-12
Figure 8-11 VCST Self Diagnostic Flow Chart 8-23
Figure 8-12 VSST Self Diagnostic Flow Chart 8-26
Figure 8-13 TURBO Timing Chart 8-27
Figure 8-14 Detector Troubleshooting Flow Chart 8-29
Figure 8-15 RAW Data.exe Screen 8-31
Figure 8-16 Noise Test Spreadsheet 8-32
Figure 8-17 Ideal Noise Test Result 8-33
Figure 8-18 Acceptable Noise Test 8-34
Figure 8-19 Passed with Slight Fuzz 8-34
Figure 8-20 Failed with High Drift 8-36
Figure 8-21 Noise Test Flow Chart 8-37
Figure 8-22 Lamp Stability Drift Comparison 8-38

x Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

1 Introduction

1.1 Introduction

The VARIANT™ II TURBO Hemoglobin Testing System is a third-generation VARIANT


system with front-end automation and Clinical Data Management software specific for
TURBO applications. The high volume Hemoglobin A1c application is formulated for a
short analysis time. The system consists of two modules - the Chromatographic Station
and the Sampling Station. Although the VARIANT II TURBO uses the same modules as
the VARIANT II, there are some modifications to the chromatographic station that are

Introduction
required for sample analysis. There are also reliability upgrades that are required on both
modules. Refer to Section 1.2 for a list of these changes. The VARIANT II TURBO is
shown in Figure 1-1.

Figure 1-1:
The VARIANT II
TURBO Hemoglobin
Testing System

The VARIANT II TURBO Service Manual is intended for Bio-Rad or other appropriately
trained service personnel, as a tool when troubleshooting or performing maintenance on
the VARIANT II TURBO Hemoglobin Testing System.

The Spare Parts section contains a pictorial list of parts required to upgrade a VARIANT II
to VARIANT II TURBO and also contains reliability parts for both systems.

L70243200 Service Manual 1-1


VARIANT ™ II TURBO Hemoglobin Testing System

1.2 System Modifications

Changes to the hardware in both the VSS and VCS are required for proper sample analysis
using the VARIANT II TURBO HbA1c program. These include the replacement, or
addition of the following parts:

TURBO SPECIFIC

VCS
• Column Heater Block
• Pre-heat Tubing Coil
Introduction

• Cartridge Holder
• Mixing Coil Tubing

VSS
• Sample Needle
• Needle Cover
• Dilution Chamber
• Tube Holder Driver PCB (# 293)
• XYZ Connect PCB (#294-254-1)
• Z Sensor PCB (#294-255-7)
• Z Axis PCB (#294-254-4)
• Z Axis Cable 1, 20 pin
• Z Axis Cable 2, 5 pin

RELIABILITY UPGRADES

• Tube Holder Upgrade ver. 4


• 6 Port Valve Rotor Seal
• Pinch Valves 3 and 4 with Bracket
• Internal Waste Tank Baffle
• Waste Tubing Assembly (P/V 3 and 4)

All other remaining hardware is unchanged from the original VARIANT II system.
Instructions for upgrading to a VARIANT II TURBO can be found in the VARIANT II
TURBO Upgrade Instructions (L70242100), which is included with the upgrade kit.

1-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

1.3 Safety Precautions

1.3.1 Electrical

The main electrical hazard on the VARIANT II TURBO is the primary AC wiring. The
primary AC wiring is located at the back of the chromatographic station and on the right
side of the sampling station. This wiring is used to provide power to the DC power
supplies of each unit and carries a voltage anywhere from 100 v to 240 v. The wiring after
the power supplies carries 24 Volts DC or less and does not represent a shock hazard.
Nevertheless, always treat ANY wire as if it carried a hazardous voltage.

Introduction
1.3.2 Mechanical

When servicing the VARIANT II TURBO, it is important to remember that it is an


automated instrument with many subsystems. When the instrument is operating, any of the
assemblies within the instrument may start at any time. It is critical to keep the head,
fingers, loose clothing, ties, hair and jewelry out of the way of moving parts.

1.3.3 Biohazardous

WARNING: The VARIANT II TURBO receives and transfers biohazardous fluids


throughout the system; therefore, the instrument must always be treated as having
been exposed to infectious agents. Use caution when servicing the unit and follow
local regulations regarding the treatment of spills and the disposal of biohazardous
materials.

The primary function of the VARIANT II TURBO is the analysis of blood samples. Care
must be taken when the instrument is serviced to prevent exposure of service personnel to
infectious agents. The decontamination procedure, found in the VARIANT II TURBO
Hemoglobin Testing System Operation Manual, MUST be followed prior to servicing the
instrument. The Sample Needle MUST be removed to avoid puncture when servicing the
Sampling Station.

WARNING: The Sample Needle is EXTREMELY sharp. Caution must be used


during removal or installation.

L70243200 Service Manual 1-3


VARIANT ™ II TURBO Hemoglobin Testing System

1.3.4 Safety Procedures

Personal Protective Equipment (PPE) is required for all personnel working on the
VARIANT II TURBO. Safety procedures include:

1. Remove wristwatches and jewelry to better facilitate hand washing and prevent the
puncture of disposable gloves. Double gloving is highly recommended when handling
infectious or potentially infectious material. Change gloves if they become cut or
punctured to prevent skin exposure to infectious material.

2. Completely protect any cut, abrasion or rash on the skin before working with potentially
infectious material. Seal with a waterproof bandage under protective clothing. Do not
Introduction

handle potentially infectious material if the exposed injury cannot be completely sealed.

3. Laboratory coats (cloth or disposable), gowns, smocks or uniforms must be worn while
in the laboratory or clean up room. Remove the protective clothing if visiting a "clean"
area of the laboratory (offices, cafeteria, etc.). Disposable lab coats should be disposed
of in a biohazard container before permanently leaving the work area.

4. Wash hands thoroughly with soap and water after working with any potentially
infectious agent or equipment before leaving the work area, and especially if skin is
exposed to an infectious agent.

5. Keep hands away from mouth, nose and eyes. Avoid touching the eyes while working,
as it is a common route for infectious agents to enter the body. Safety glasses with side
shields are required, especially for individuals who wear contact lenses. Goggles or
face shields are required if there is a potential for splashing.

6. Do not use gloved hands to write, answer the telephone, turn on a light or touch
anything that ungloved personnel may handle. Only materials needed for immediate
procedures should be in the vicinity of the work area. Do not expose books or other
materials that cannot be properly decontaminated.

1-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

2 Specifications
2.1 Sampling Station Physical and Electrical Specifications

Dimensions (approx.) 62 cm (W) X 60 cm (D) X 46 cm (H) from


counter top (25” X 24” X 19”)

Weight – Uncrated (approx.) 63 kg (139 lbs.)

Operating Temperature Ambient (15-35o C)

Humidity 10 - 90%

Storage Conditions -20o C to 50 o C; (0° F to 120° F); Humidity 10 -


95%

Line Voltage Selected Automatically

Specifications
100 to 240 volts AC

50/60 Hz

Power Consumption <150 VA

Communication Port RJ45 connector


RS232C bi-directional serial port

2.2 Sampling Station Component Specifications

Sample Rack Handling

Sample Rack Sysmex #3 (P/N 2702006) with


13 mm rack adapters

10 sample capacity

Capacity 10 racks (5 on each belt)

Rack Movement Conveyor Belts

Rack Handlers front and back

L70243200 Service Manual 2-1


VARIANT ™ II TURBO Hemoglobin Testing System

Sample Tube Handling

Capacity 100 samples, primary tubes or pre-dilutions

Tube Sizes Primary Tubes: 16 mm (no rack adapter)


12, 13 and 14 mm (with rack
adapter)

Pediatric Tubes: 10 mm with Tube Adapter


(P/N 2702017-10)

Pre-Diluted: 1.5 mL microvials (P/N


2702149) in Tube Adapter (P/N
2702016-10)

Tube Sensing Reflective optosensors at 2 heights that


distinguish primary, pediatric and pre-diluted
samples
Specifications

Barcode Reader

Reader Unit Keyence/Model BL-180

Specification ASTM E 1466-92 compatible

Symbologies Code 39 (with and without check digit)


ITF (with and without check digit)
Industrial 2 of 5
Codabar (NW-7) (with and without check digit)
EAN/UPC (-A and -E)
Code 128
COOP 2 of 5
Parsing option available for all barcodes

Barcode Reading Automatic rotation of primary sample tubes for


sample identification

Barcoded Microvial Tube Adapters for Primer,


Blank, Calibrator and Controls

The Rack Barcode, which is placed between the


first and second position on the rack, is read
before the first sample

Rack Barcode Slot between first and second sample position


on the rack for rack ID label

2-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Liquid Handling

Syringes Two Ito Syringes: 1 mL for sample aspiration and


5 mL for Wash/Diluent Aspiration

Syringe Specifications Sampling Volume: 5 to 200 µL


Increments of 0.1 µL per step
Accuracy is the greater of either + 1 µL or 5%

Diluent Volume: 30 to 600 µL


Increments of 0.5 µL per step
Accuracy is the greater of either + 3 µL or 5%

Primary Tube Dilutions Two step dilution


Sample Volume Aspiration: 15 to 25 µL (Assay
specific)
Initial Diluent Volume: 475 to 482 µL (Assay

Specifications
specific)
Secondary Diluent Volume: 431 to 470 µL (Assay
specific)

Cycle Time Less than 100 seconds under the following


conditions:

2 step dilution, single piercing, no spinning, wash


volume 1 mL for needle, dilution well and sample
line between VCS and VSS (total 3 mL), mixing
250 µL one time, 100 mm length primary tube

Dilution Precision 1:10 to 1:200: < 3%


1:200 to 1:400: < 5%

Carry-over < 1% at 1:20 dilution

Waste per sample Maximum 3 mL for each primary tube sample

L70243200 Service Manual 2-3


VARIANT ™ II TURBO Hemoglobin Testing System

Sample Needle

Needle Description Cap piercing, dual grooved, side port type

Length 122 mm

Material Stainless Steel

Lifetime 20,000 piercings

Dilution Chamber Dilution of primary tube samples or transfer of


pre-diluted samples and separate needle wash port

Evacuation by vacuum pump and regulated by


pinch valve movement
Maximum 600 µL capacity

Dead Volume: Less than 50 µL


Specifications

Internal Waste Tank Approximate 200 mL volume with level sensor

Evacuated to external waste by pressure from the


vacuum pump output

External Waste Tank 10 L plastic with level sensor

Fluid Pathway Tubing

Sample Line (needle to Teflon


syringe pump assembly) Length: 550 mm
O.D./I.D.: 2.0 x 1.0 mm

Sample Line (dilution Teflon


chamber to sample port) Length: 700 mm
O.D./I.D.: 1.58 x 0.5 mm

Wash/Diluent Line (inlet Silicon rubber


port through syringe Length: 695 mm
assembly, including pinch O.D./I.D.: 4.0 x 2.0 mm (port to syringe)
valves 1 and 2) 3.0 x 1.0 mm (remainder)

2-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Dilution Chamber Drain Silicon rubber


Line (through PV 3 Length: 770 mm
to 2nd T-fitting) O.D./I.D: 5.0 x 3.0 mm

Drain Port Drain Line Silicon rubber


(to 1st T-fitting, through Length: 730 mm
PV4 and PV3) O.D./I.D.: 5.0 x 3.0 mm

Wash Port Drain Line Silicon rubber


(through PV4 to 2nd Length: 760 mm
T-fitting) O.D./I.D.: 5.0 x 3.0 mm

Waste Line (2nd T-fitting Silicon rubber


to Internal Waste, Length: 640 mm
through PV7) O.D./I.D.: 5.0 x 3.0 mm (through PV7)
7.0 x 4.0 mm (remainder)

Waste Line (internal Silicon rubber


waste to external waste Length: 890 mm
port) O.D./I.D.: 7.0 x 4.0 mm (internal waste to joint)

Specifications
5.0 x 3.0 mm (joint through PV7 to T-
fitting)
7.0 x 4.0 mm (Joint to T-fitting)
8.0 x 5.0 mm (union to external port)

2.2.1 Regulatory Compliance

EMC

EMI FCC Part 15 Subpart B (Class A)


EN55011 (VDE 0871) (Class B)
EN61326 (Radiated and Conducting Emissions
Only) with Compaq Slimline Desk Pro EN PC

Immunity IEC801-2 (Static Discharge)


IEC 801-3 (Radiated electromagnetic field)
IEC801-4 (Fast transient BURST)

Electrical safety UL 3101-1/10.93

L70243200 Service Manual 2-5


VARIANT ™ II TURBO Hemoglobin Testing System

2.3 Chromatographic Station Physical and Electrical


Specifications

Dimensions (approx.) 28 cm (W) X 41 cm (D) X 53 cm (H) (11” X 17”


X 21”)

Weight - Uncrated
(approx.) 33 kg (73 lb)

Operating Temperature Ambient (15-35o C)or (59-95o F)

Humidity 10 - 90%

Storage Conditions -20o C to 50 o C (0° F to 120° F); Humidity 10 -


95%

Line Voltage Selected Automatically


Specifications

100 to 240 volts AC

50/60 Hz

Power Consumption 200 Watts maximum

Communication Port RJ45 connector

RS232C bi-directional serial port

2.4 Chromatographic Station Component Specifications

Detector

Wavelength Sample: 415 + 3 nm


Reference: 690 + 3 nm

Flow Cell Tapered Cell


18 µL Volume

Optical Path Length 10 mm

Light Source Tungsten Halogen lamp (6V, 10 W)

Expected Lamp Life Time 2000 Hours

2-6 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Linearity + 1% of Theoretical absorbance at 0.8 A.U.


(based on extrapolation from lower
concentrations)

Switching Noise 2.0 mV with VARIANT QC procedure with 270


µL Dynamic Mixer

Baseline Noise < 200 µV peak to peak (10 minute test period
after 30 minute warmup)

Baseline Drift < 1.0 mV per hour (one hour test period after 30
minute warmup)

Dual Piston Pumps

Flow rate range 0.1 to 3.0 mL/min in 0.01 mL increments (each


pump)

Maximum pressure 4000 psi (280 kg)

Specifications
Accuracy + 2%

Precision + 1.0%

Test condition for Flow Rate Range: 0.4 to 2.5 mL/min


accuracy and precision
Pressure Range: 0-2000 psi

Pulsation Level Maximum 10% both pumps

Test Condition for QC Flow Rate 2.0 mL/min with 270 µL Dynamic
Mixer and backpressure of 100 kg/cm2

Piston Washing Manual washing with piston wash port

Should be performed before and after operation

Expected Lifetime of 2000 hours


Pump Seals

L70243200 Service Manual 2-7


VARIANT ™ II TURBO Hemoglobin Testing System

Dynamic Mixer (Gradient System)

Composition 0 to 100% in 0.1% increments

Accuracy of Gradient + 0.5% B

Precision of Gradient + 0.3% B

Test Range for Flow Rate: 0.9 to 2.5 mL/min


accuracy and precision
Composition Range: 10-90%

Void Volume 270 µL

Mixing Speed 300 rpm

Mixer Selection Dynamic or T mixer selected automatically via


Rheodyne 7 port valve
Specifications

Coil Mixer

Volume 360 + 10 µL

Tubing 1/16” OD x 0.5 mm ID Stainless Steel

Pressure Sensor

Construction Strain Gauge

Maximum Pressure 350 kg/cm2 (5000 psi)

Accuracy + 5% or 2 kg/cm2 (20 psi), whichever is greater

Precision + 2% or 2 kg/cm2 (20 psi), whichever is greater

2-8 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Degasser

Construction 2 channel Teflon® tubular membrane in vacuum


chamber

Vacuum Level of Chamber 400 - 1000 hpa/10hpa step programmable and


vacuum off

Setting Level = 500 hpa

Vacuum Level Accuracy Set level + 35 hpa at 23o C (77° F)

Vacuum Error Detector Allowable Range = + 100 hpa of the set level

Injection Valve (Rheodyne 6 port - RV700123))

Sampling Method Complete loop filling

Specifications
Loop Size 23 µL

Filling Speed 0.1 - 2.0 mL/min in 0.1 mL /min increments

Overfill Volume 10 to 200 µL in 1 µL increments

Accuracy Dependent on Sample Loop Size (nominal +


10%)

Precision < 1.0%

Line Flush Volume 0 to 4.0 mL in 0.1 mL increments

Carryover <0.1% with 2.0 mL flush volume at 20 µL sample


loop size

Column Heater Unit

Cartridge Holder
Size 18 mm O.D. x 62 mm Length (74 mm fitting
to fitting)

Temperature Range 22o C to 50o C in 1o increments

Accuracy + 1o C

L70243200 Service Manual 2-9


VARIANT ™ II TURBO Hemoglobin Testing System

Stability + 0.5o C

Pre Heater Tubing Coil 1/16 “ O.D. x 0.25” I.D. x 610 mm long Stainless
Steel

Reagent Reservoir Tray

Composition Stainless Steel with 3 bottle ( 2 L) capacity and


liquid volume sensor

Tray 1: Buffer A/1


Tray 2: Buffer B/2
Tray 3: Wash/Diluent

Liquid Volume Sensor Strain Gauge


Detector performance: 5 - 90%, programmable in
1% increments

Accuracy: + 5% of 2.0 L full scale at 23˚ C


Specifications

Fluid Pathway Tubing

Sample Line Port to Teflon


Injection Valve Length: 500 mm
O.D./I.D.: 1.58 x 0.5 mm

Wash/Diluent Port to Teflon


Syringe Length: 570 mm (through 3-way solenoid)
O.D./I.D.: 3.18 x 1.58 mm

3-way solenoid to Teflon


Injection Valve (6 port) Length: 600 mm
O.D./I.D.: 1.58 x 0.8 mm

Buffer A Port to Pump A Teflon


Length: 500 mm (through 2-way solenoid; to and
from degasser)
O.D./I.D.: 3.18 x 1.58 mm

Buffer B Port to Pump B Teflon


Length: 330 mm (to and from degasser)
O.D./I.D.: 3.18 x 1.58 mm

2-10 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Pump T-Fitting (post Stainless Steel


Pressure Sensor) to Total Length: 910 mm (through 7 port valve,
Column Holder dynamic mixer and injection valve)
O.D./I.D.: 1.58 x 0.25 mm

7 port Injector (Purge Stainless Steel


Position) to T-fitting Length: 210 mm
(pre drain line) O.D./I.D.: 1.58 x 0.25

Column Holder to PEEK


T-fitting (pre drain line) Length: 630 mm (through flow cell)
O.D./I.D.: 1/16 inch x 0.01 inch

T-fitting (pre drain line) Teflon


to Drain Port Length: 360 mm
O.D./I.D.: 3.18 x 1.58 mm

Piston Wash Line Tygon™


(inlet port to pump drain Length: 950 mm (through siphon break)

Specifications
port) O.D./I.D.: 1/8 inch x 3/16 inch

Pump Drain Line Silicon


(outlet port to waste) Length: 2.5 m
O.D./I.D.: 8 mm x 5 mm

Drain Line PVC


(outlet port to waste) Length: 2.5 m
O.D./I.D.: 11 mm x 6 mm

2.4.1 Regulatory Compliance

EMC

EMI FCC Part 15 Subpart B (Class A)


EN55011 (VDE 0871) (Class B)
EN61326 (Radiated and Conducting Emissions
Only) with Compaq Slimline Desk Pro EN pc

Immunity IEC801-2 (Static Discharge)


IEC 801-3 (Radiated electromagnetic field)
IEC801-4 (Fast transient BURST)

UL 3101-1/10.93

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VARIANT ™ II TURBO Hemoglobin Testing System

2.5 Minimum Computer Specifications

Processor Intel Pentium® II


350 MHz
Bus speed 100 MHz

Cache 512 KB EEC Level 2 synchronous pipeline


Burst SRAM

Memory 128 MB

Diskette Drive 1.44 MB

Hard Drive SMART Ultra ATA 6 GB

USB Ports 2

Graphics Memory ATI RAGE PRO TURBO AGP 2X with


4 MB SGRAM
Specifications

Audio Embedded 16 bit audio

Keyboard Compaq Enhanced Keyboard

Mouse PS2

Monitor 15 inch Compaq 110/220 V

OS Software Windows NT 4.0, SP4 or SP6


(platform dependent)

CD R/W Internal , 6X read, 2X write

Network Card Compaq 10/100 TXPCI Intel WOL Controller

Serial Card Rocket Port 4 x RJ45 or ConnectTech 4 x DB-9


(platform dependent)

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VARIANT ™ II TURBO Hemoglobin Testing System

3 Installation and De-Installation

3.1 Installation Requirements

1. Choose a location that is away from direct sunlight and is relatively dust free.
2. Room temperature should be between 15 and 30º C (60-85ºF).
3. The bench or table should have a flat, level surface that is free from vibrations and is
capable of supporting up to 115 kg (about 250 lb).

NOTE: All four feet of the VSS MUST be on the counter. If the surface is not
deep enough to accommodate the front feet, obtain removable footpads from a
local hardware or home improvement store. Secure them under the VSS, one
on each side, far enough back so they allow the module to be level and secure
on the counter.

4. A grounded electrical receptacle should be within 1.8 meters (6 feet) of the system.
5. The maximum power consumption is 1750 VA (VCS, VSS, CPU, monitor and
printer).
6. The Personal Computer (PC) should be located as close to the VARIANT II TURBO
as possible to provide adequate room for communication connections.

3.2 Unpacking and Inspection

The VARIANT II TURBO will arrive in three separate boxes; one for the VSS, one for the
VCS and one for the Accessories. The PC, monitor and printer will also be in separate
boxes. A Customer Acceptance Form and System Warranty Card should be completed by

Installation
the customer and returned to Bio-Rad Laboratories after inspection of the system.

Accessories
Remove all accessories from the box and verify that all components are present. The
following is a list of all accessories supplied at installation:

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VARIANT ™ II TURBO Hemoglobin Testing System

Waste Tank (10 L)


Waste Tank Tubing (2 for VCS, 1 for VSS)
Waste Level Sensor
Dummy Cartridge (installed in the cartridge holder)
Sysmex Racks (10)
Sysmex Rack Adapters (12 mm, 13 mm and 14 mm)
Pediatric Tube Adapters (10)
Microvial Adapters (10)
Barcode Labels (Primer, Blank, Cal 1, Cal 2, Control 1, Control 2)
Allen Wrenches (4)
Wrench (2)
Syringe Luer Tube Assembly
Reservoir Unit
Reservoir Unit Cables
Communication Cables: RJ-45 to RJ-45 (2)
Communication Cables: RJ-45 to DB-9 (2)
Power Cables (2)
Extra Fuses
Reagent Tubing and Caps (3)
Sample Tubing
Flangeless Fitting Nut and Ferrule Set
Pump Seal
Pump Seal Remover Tool
Screw Drivers (2)
Decon Tubing
Syringes
Mouse Pad
Operation Manual
Warranty Card

VARIANT II

1. Remove the ties surrounding the two larger boxes. Lift the top box off of each base.
Installation

Figure 3-2:
Unpacking
the VCS

Figure 3-1:
Unpacking the VSS

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VARIANT ™ II TURBO Hemoglobin Testing System

2. Remove the protective bags from around the VCS and VSS.
3. Each module is heavy, requiring at least two people to lift. Carefully lift the VCS
onto the bench top and position it so that all of the rubber feet are squarely in
position. Repeat with the VSS, PC and printer. Remove the monitor and place it on
top of the PC.
4. Remove the needle cover and front bezel cover from the VSS. Disconnect and save
the sampling arm shipping bracket. Make sure the sample probe is connected
properly. Replace the front bezel cover and needle cover.

3.3 VARIANT II TURBO System Setup

NOTE: The remainder of the installation procedure requires a working


knowledge of CDM 3.6T and the VARIANT II TURBO Service Software. If
needed, consult the CDM 3.6T Operation Manual and Section 5 of the
VARIANT II Service Manual for additional information.

Reservoir Cable and Power Cords

1. Connect one end of the reservoir cable to the Reservoir Unit and the other end to the
back of the VCS. Place the reservoir unit on the VSS behind the right belt.
2. Connect the power cords to the VSS, VCS. PC, monitor and printer. Plug all power
cords into power outlets.
Turn on the PC. Start CDM from the icon on the desktop. In the SETUP/Configuration
screen verify that the instrument type is VARIANT II. Set the communication ports for the
VCS (gradient module) and VSS, for Instrument 1, based on placement at the back of the
PC. The system must be in Inactive state to make changes to the port settings.

Installation

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VARIANT ™ II TURBO Hemoglobin Testing System

Communication Ports for HP Compaq D530 Series Computer

The HP Compaq D530 series computer requires the use of a multi-line communication
cable. This line replaces the 4 port rocket board from previous computers supplied with
the VARIANT II. The end of each cable is a DB-9 male connector requiring the use of the
RJ-45 to DB-9 cables supplied with the system. Figure 3-3 shows the communication port
numbers on the back of this PC.

4 5 6 7

1 2

Figure 3-3: HP Compaq D530 Series Computer

Waste Tank and Lines

1. Remove the caps from the waste tank. Remove the inner seal from the main cap.
2. Insert the terminal end of the waste tank sensor cable through the main cap. (Figure
3-4)
Installation

Figure 3-4: Waste


Tank Level Sensor

3. Place the waste sensor into the tank and screw the main cap over the sensor until it is
tight. Connect the waste tank signal cable to the terminal labeled WASTE on the
back of the VCS.
4. Create a small vent hole in the secondary cap and install the cap on the waste tank.
5. Remove the caps from the barbed fittings for waste at the back of the VCS and VSS.
Retain the caps.
6. Connect one silicon tube to the Waste port at the back of the VSS. Connect the other
silicon tube to the Pump Drain port at the back of the VCS. Connect both to the

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VARIANT ™ II TURBO Hemoglobin Testing System

waste tank inlet. The tubing should have sufficient length to reach the waste tank on
the floor. Cut if necessary.
7. Connect the remaining Tygon tube to the Drain port at the back of the VCS. Connect
the opposite end to the waste tank inlet. The tube should have sufficient length to
reach the waste tank on the floor. Cut if necessary.
8. Place the waste tank in a position so the tubing is sloped downward at all times.

Reagent and Sample Lines

1. Remove all inlet port plugs from the reagent and sample ports at the back of the VCS
and VSS and save them.
2. Connect the finger-tight fittings for Buffers A, B and Wash/Diluent tubing to the
appropriate ports on the VCS and VSS. The caps of the buffer lines are marked
accordingly. Make sure the fittings are tight and are not cross-threaded.
3. Connect one end of the sample line at the back of the VSS and the other at the back
of the VCS.
4. Unpack the buffer and wash bottles from the application to be installed. Remove the
caps and replace with the corresponding buffer and wash lines. Make sure the
solvent filter is at the bottom of the bottle and the caps are tight. DO NOT grasp the
tubing below the cap or the solvent filter with bare hands as it may cause
contamination of the buffer.
5. Place the buffer and wash bottles in their appropriate positions on the reservoir unit.

Guard Cartridge and Analytical Cartridge Installation

1. Open the cover to the VCS. Locate the column heater in the center of the VCS. Turn
the latch and open the door.
2. Remove the cartridge holder from the clip at the top. (Figure 3-5)

Installation

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VARIANT ™ II TURBO Hemoglobin Testing System

Figure 3-5:
Cartridge
Holder

3. Unscrew the top of the cartridge holder and remove the dummy cartridge. Insert a
new analytical cartridge from the reorder pack, making sure the arrow on the
cartridge is pointing in the same direction as the arrow on the cartridge holder.
Replace the top of the cartridge holder.
4. Unscrew the bottom of the cartridge holder and remove the dummy cartridge. Insert
a new guard cartridge from the reorder pack, making sure the arrow on the cartridge
is pointing in the same direction as the arrow on the cartridge holder. Replace the
bottom of the cartridge holder.
5. Place the cartridge holder back into the clip of the column heater. Close the column
heater door and secure it with the latch.

Priming the Lines


Installation

Prior to shipment the fluid lines within the VCS are filled with a very weak concentration
of phosphoric acid (0.01%). Prime the lines before the first operation to remove all fluid
and air bubbles that may be trapped.

1. Turn the VCS power on. The system will perform a short self-check.
2. Turn the VSS power on. The system will perform an initialization.
3. In CDM select the Instrument 1 icon at the top left of the screen. Select Return to
Active in the status window. When prompted "Do you want to perform the
automatic warmup operation" select No. The instrument will go into Ready state.
Close the status window by selecting OK.

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VARIANT ™ II TURBO Hemoglobin Testing System

NOTE: If either the VARIANT or VSS communication status, in the status window,
says "Not OK" in red, then the communication port for that module may not be set
correctly. Close the status window by selecting OK. Select MAINTAIN/Instrument
and select Make Inactive at the bottom of the screen. Select No when asked about
performing a Shutdown. Select SETUP/Configuration and set the communication
ports to the correct settings. Repeat Step 3. If there is still no communication verify
that the cable is inserted correctly.

4. Remove the 25 mL syringe from the accessories box. Place the syringe securely into
either one of the two pump ports. Open the port 1/2 turn counterclockwise.
5. Slowly pull back on the syringe plunger until it is filled to 25 mL. Close the pump
port, remove the syringe and dispose of the fluid.
6. Repeat Steps 4-5 until no bubbles are seen coming from the port.
7. Repeat Steps 4-6 for the other pump port.

Flush the Piston/Seal Wash Port

1. Remove the 10 mL syringe from the accessories box. Fill the syringe with 10 mL
deionized water.
2. Securely insert the syringe into the piston/seal wash port. Slowly inject the water into
the port.
3. Remove the syringe.

System Flush

A system flush of all fluid lines is required prior to first operation. The short flush will
take 20 minutes to complete and flushes the buffer and wash lines in both the VCS and

Installation
VSS.

1. Select SETUP/Test in CDM. Select the down arrow next to the field Select New
Test and change the test to the application to be run. Acknowledge the message
about making sure the correct reagents and cartridge are in place.
2. Select either the cartridge or reagent radio button. Select Start System Flush at the
bottom of the screen. Select Short flush then OK to begin the flush.
3. When the flush is complete select the Instrument 1 icon at the top left of the screen.
Select Return to Ready. When the instrument status changes to Ready select OK to
close the status window.

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VARIANT ™ II TURBO Hemoglobin Testing System

NOTE: The 7 port valve will stay in purge position until the system is returned to
Ready state.

Checking Pump Pressures and Leaks

1. Open the MAINTAIN/Instruments window in CDM 3.6T. Locate the box labeled
Pump. Check the pressure on Pump A by entering 0 in the %B field. Set the Flow
Rate at the rate defined for the installed cartridge. Refer to the SETUP/Test/ Edit
Test screen for the appropriate test to find the proper flow rate. Leave the Upper and
Lower Pressure Limits at the default settings. Set the Flow Timer to 5 minutes.
Figure 3-6 shows an example of the pump settings.
2. Open the MAINTAIN/Instruments window in CDM 3.6T. Locate the box labeled
Pump. Check the pressure on Pump A by entering 0 in the %B field. Set the Flow
Rate at the rate defined for the installed cartridge. Refer to the SETUP/Test/ Edit
Test screen for the appropriate test to find the proper flow rate. Leave the Upper and
Lower Pressure Limits at the default settings. Set the Flow Timer to 5 minutes.
Figure 3-6 shows an example of the pump settings.

Figure 3-6:
Pump Settings
Installation

3. Open the front door of the VCS and the column heater.
4. Select Start Flow. Let the pump run for 2-3 minutes and then observe the pressure
reading at the bottom of the screen. The pressure should be stable with a range of +/-
5% from the mean pressure. If unstable, refer to the following section on removing
air from the pumps.
5. Check for leaks at all stainless steel fittings in the VCS, especially around the
cartridge holder during the remaining time.
6. Check Pump B by changing the %B field to 100. Repeat Step 3 and 4.
7. Close the column heater and front door of the VCS.

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VARIANT ™ II TURBO Hemoglobin Testing System

8. Select Return to Ready at the bottom of the screen.

Removing Air from the Pumps

Unstable pressure, with no leaks in the fluid path, indicates the presence of air in the pump.
The following procedure should be used to eliminate air from all parts of the unstable
pump.

1. Using the 8 mm and 10mm wrenches, disconnect the stainless steel nuts from the
outlet check valves at the top of the pump. Use the 10 mm wrench to hold the check
valve in place while turning the nut counterclockwise with the 8 mm wrench.
Completely remove the nut and ferrule from the fitting.
2. Open the MAINTAIN/Instruments screen in CDM 3.6T. Enter the appropriate
setting for the pump in the %B field (0 for Pump A, 100 for Pump B). Set the flow
rate to 3.0. Leave the default settings for Upper and Lower Pressure Limit. Set the
timer for 1 minute.
3. Place an absorbent cloth or paper towel under the pump. Select Start Flow. Let the
pump run for 1 minute.
4. Using the wrenches reconnect the outlet lines to the check valves being careful not to
cross thread or over-tighten the fitting. Use a tissue or paper towel to remove all
fluid from around the fitting.
5. Set the flow rate to the flow rate defined for the installed cartridge. Change the timer
setting to 10 minutes. Start the flow. Check for leaks, while the pump is running, at
the outlet check valves by holding a tissue or other thin, absorbent material up to the
fitting. Tighten the fitting further if liquid is absorbed onto the tissue. Check the
pump pressure at the bottom of the screen after the pump has run almost 10 minutes.
If the pressure is still unstable, repeat steps 1-4 above.

Configuration Fields

Installation
Edit the following fields, according to user preference, in SETUP/Configuration (Figure 3-
7) while the system is in Ready state:
• System Name - usually includes the serial number of the instrument
• Date Format and Separator - default is Month/Day/Year
• Unity ID and PC Export Path - for members of the Unity program
• LIMS Communication Port - define a port other than 0 only if connected to a
LIMS system
• Auto Import from LIMS - select to change from Off to On; used for
downloading additional patient information from LIMS
• Instrument Name for Instrument 1 - usually site name
• Instrument Name for Instrument 2 - only if 2 systems connected to PC
• Auto Report Printing - check to print all data and reports during a run

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VARIANT ™ II TURBO Hemoglobin Testing System

• Automatic LIMS Export - check to upload results automatically when sample


analysis complete
• Beep on Alerts - check to hear audible alarm for error messages
• Automatic Warm Up - check and set time (24 hour clock) and days of week
• Set Barcode - 4 symbologies must be chosen with one being CODE 128
(used for rack and adapter barcodes provided with the system)
Installation

Figure 3-7: Configuration Screen

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VARIANT ™ II TURBO Hemoglobin Testing System

Microvial Adapters

1. Remove the microvial adapters and barcodes from the accessories box.
2. Label the adapters with the appropriate barcodes for the application(s) to be used.

Hardware Checks

Some parts of the VCS and VSS may need to be checked at time of installation.. These
include:

Reagent Tray Level Sensor


2-Way Valve in VCS
Z height for Minimum Dead Volume

Refer to the appropriate part of Section 5 of the VARIANT II Service Manual for details of
the procedures.

Installation

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VARIANT ™ II TURBO Hemoglobin Testing System

3.4 De-Installation

NOTE: Prior to shipment decontaminate the sample fluid pathway and clean the
sample needle. Refer to the VARIANT II TURBO Operation Manual for the
procedures.

The following items are required for shipping a de-installed unit:

Pallet
5-6 Plastic Bags (assorted sizes)
Plastic Coverings (VCS and VSS)
Package Sealing Tape
Strapping material
Plastic wrap

Boxes
VCS (with wooden pallet)
VSS (with wooden pallet)
Monitor
PC (with box for keyboard and mouse)
Printer
Accessories
Reservoir Unit (padded)

1. Remove the buffer and wash bottle lines from their respective bottles. Place the lines
into a container filled with deionized water placed on top of the VSS (not on the
bottles). Cap the buffer and wash bottles but do not remove them from the reservoir
tray.
2. Perform a Short System Flush. Refer to Section 3.3 - System Flush for the
procedure.
Installation

3. Perform the Decontamination procedure from Section 5.6 of the VARIANT II


TURBO Operation Manual.
4. Open the MAINTAIN/Instruments screen in CDM. Select Make Inactive at the
bottom of the screen and select Yes for shutdown. Close CDM.
5. Remove the buffer and wash bottles from the reservoir tray.
6. Turn off the power on the VCS and VSS. Shut down the computer via the Start
button at the bottom of the screen. Turn off the computer when prompted then turn
off the monitor.
7. Disconnect the communication cables from the VCS, VSS and PC. Disconnect the
reservoir level sense cable. Place all cables in a plastic bag for shipment.
8. Disconnect the power cords from the VCS and VSS and place in a plastic bag for
shipment.
9. Remove the buffer and wash lines from the deionized water and dispose of the water.
Disconnect the buffer and wash lines from the back of the VCS and VSS. Drain the

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VARIANT ™ II TURBO Hemoglobin Testing System

lines completely and blot the solvent filters on a lint free cloth. Insert the port plugs,
in place at install, into all buffer and wash ports. Place the lines in a plastic bag for
shipment.
10. Disconnect the waste lines from the back of the VCS and VSS. Drain the lines into
the waste container. Disconnect the lines from the waste container and place them
into a plastic bag for shipment. Place the waste port caps, present at install, on the
waste ports at the back of the VCS and VSS.
11. Disconnect the waste level sense cable from the back of the VCS. Remove the main
cap from the waste container and thread the cable through until it clears the cap.
Replace the main cap on the waste container. Place the cable in a plastic bag for
shipment.
12. Remove the secondary cap of the waste bottle. Empty the waste into a sink
designated for biohazard waste. Rinse the empty container with household bleach
followed by deionized water. Place the waste bottle in a plastic bag for shipment.
13. Remove the reservoir tray from the VSS and place in the foam padded shipping box.
Place the box into the accessories box.
14. Place the waste container along with all the tubing lines and cables from the VCS and
VSS into the accessories box. Secure the top of the box with package sealing tape.
15. Remove the needle cover and front bezel cover from the VSS. Re-install the
sampling arm shipping bracket that was removed at installation. Replace the covers
and secure them with tape.
16. Secure the front cover of the VCS with tape.
17. Place the VCS and VSS pallets on the main shipping pallet. The VCS and VSS
require two people to lift them from the counter. Place the VCS and VSS on their
respective pallets. Wrap each with the plastic covers then place the box covers over
the modules. Secure the top to the bottom of each with straps.
18. Disconnect the keyboard, mouse, printer and monitor cables from the back of the PC.
Disconnect the printer cable from the printer. Place all cables in a plastic bag for
shipment. If the shipment is going by air, the toner cartridge should be removed from
the printer and bagged separately.

Installation
19. Disconnect the power cords from the monitor, PC and printer. Place the cables in a
plastic bag for shipment.
20. Place the monitor, printer and PC in their respective boxes. Place the keyboard and
mouse in a box and place inside the box with the PC.
21. Place the cables and power cords from the PC, monitor and printer in the box with
the PC. Secure the top of all boxes with package sealing tape.
22. Place all boxes on top of the VCS and VSS boxes on the pallet. Secure the boxes
together by wrapping them with plastic wrap.

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VARIANT ™ II TURBO Hemoglobin Testing System
Installation

3-14 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

4 VARIANT II TURBO Service Software

This section describes the changes to the existing VARIANT II Service Software.
VARIANT II and VARIANT II TURBO use the same service software, but some options
cannot be used with the VARIANT II firmware. Messages will appear on the screen when
the wrong firmware is in place.

4.1 Introduction

Service software is a separate application from CDM 3.6T. It is used to make adjustments
and alignment changes to both the VCS and VSS, and to manually control both modules.
In addition, it logs hardware error codes that indicate where a specific problem exists.
These errors may cause non-specific messages in CDM 3.6T. It is then necessary to access
the service software in order to determine the source of the problem. Refer to Section 7.0
Troubleshooting for a list of the current error codes.

Service Software
Each module has its own service software. The current versions are listed below.

VCS: 1.08
VSS: 3.01

Access either software by selecting the Start button at the bottom of the screen. Select
PROGRAMS/Variant 2 Service and then either VCS 1.08 or VSS 3.01. Both applications
are password protected. Enter the password, all in capital letters, VARIANT2QC when
prompted, after selecting the appropriate software option.

NOTE: CDM 3.6T MUST either be closed or have the instrument(s) in Inactive state
in order to use the COM ports with the service software.

In the service software select the Close button in any open window to close that option.
Multiple windows can be open at any given time. To close the software select the "x" in
the upper, right corner of the Main Menu screen.

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VARIANT ™ II TURBO Hemoglobin Testing System

4.2 VCS Service Software

There are no changes to the existing VCS service software for VARIANT II TURBO.

Refer to Section 4.2 of the VARIANT II Service Manual for information on the various
screen options.

4.3 VSS Service Software

There are minor changes to the existing VSS service software for VARIANT II TURBO.
Refer to Section 4.3 of the VARIANT II Service Manual for information on the remaining
screens and options.

4.3.1 Manual Screen


Service Software

VARIANT II TURBO

The manual screen has an added option under Nozzle Z for Sensor Position. (Figure 4-1)

Figure 4-1: New VSS Manual Screen

Selecting this option will move the sampling arm down to the low sensor position.

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VARIANT ™ II TURBO Hemoglobin Testing System

VARIANT II

When connected to a VARIANT II, a warning message (Figure 4-2) will appear when the
Sensor Pos option is selected in the Manual screen. This option can only be used with
VARIANT II TURBO firmware.

Figure 4-2: Warning Message for VARIANT II

Once OK is selected for the warning, the Sensor Pos option will be removed from the

Service Software
Manual screen.

4.3.2 Sensor Status

Two new fields have been added to the Sensor Status screen: Detail and Z-Low pos.
(Figure 4-3)

Figure 4-3: Z-Low Position in Sensor Status Screen

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VARIANT ™ II TURBO Hemoglobin Testing System

4.3.2.1 Z-Low pos

VARIANT II TURBO
When the Check Status option is selected from the Sensor Status screen, data appears
in the Z-Low Pos field for the low position sensor.

VARIANT II
When the Check Status option is selected from the Sensor Status screen, the Z-Low
Pos field disappears. (Figure 4-4)
Service Software

Figure 4-4: Sensor Status Screen for VARIANT II

4.3.2.2 Status Screen Details

A Detail option has been added to the Status Screen for use by both VARIANT II and
VARIANT II TURBO. Selecting this option shows an expanded Status screen with
binary data. (Figure 4-5)

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VARIANT ™ II TURBO Hemoglobin Testing System

Service Software
Figure 4-5: Sensor Status Details

L70243200 Service Manual 4-5


Service Software VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

5 TURBO Procedures

5.1 VCS Procedures

All procedures for the VCS remain the same as in the VARIANT II Service Manual.
There are, however, some minor changes to the Column Heater Adjustment (Section 5.2),
along with the 6 and 7 Port Valve Rotor and Seal Replacement Procedure (Section 7.1.11).

Procedures
5.1.1 Column Heater Adjustment

The following is a change to Section 5.2, Step 9 of the VARIANT II Service Manual.

• Verify that the temperature is calibrated correctly by using a digital thermometer.


Place the probe into the hole under the tubing coil and into the groove on the
heater block. Close the door. Figures 5-1 and 5-2 show proper placement of the
probe.

Figure 5-1: Temperature Figure 5-2: Temperature


Probe in Column Heater Probe with Door Closed

Allow adequate time for equilibration. The temperature reading must be within 1
degree of the CDM display.

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VARIANT ™ II TURBO Hemoglobin Testing System

5.1.2 6 and 7 Port Valve Rotor Seal and Stator Replacements

The following is an addition to Section 7.1.11, of the VARIANT II Service Manual.

• The diagrams in Figures 5-3 and 5-4 show the correct tubing connections for the
6 and 7 port valves.

Port 4 of 7
Figure 5-3: 6 Port
port valve
Procedures

Valve Connections

Preheating 3 Way Valve


Coil

Sample Sample
Inlet Line Loop

Waste

Port 2 of the
6 port valve
Dynamic
Mixer
Pump

Coil
Mixer Figure 5-4: 7 Port
Valve Connections

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VARIANT ™ II TURBO Hemoglobin Testing System

5.2 VSS Procedures

Refer to the VARIANT II Service Manual for VSS alignment procedures. The procedures
for TURBO are the same as for the VARIANT II; however, figures 6-39 and 6-64, of the
Manual screen, are screen captures from the previous version of VSS Service Software.
The change in the Manual screen for the latest version of service software does not affect
the procedures that reference these two figures.

Procedures

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Procedures VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

6 Replacement Procedures

6.1 VCS Replacements

The following procedure from the VARIANT II Service Manual has been modified for
TURBO:

• Section 7.1.6 Column Heater Block

Replacements
All other VCS replacement procedures remain the same as in the VARIANT II Service
Manual.

6.1.1 Column Heater Block Replacement

The column heater block for TURBO contains a pre-heat tubing coil.

Follow the procedure in Section 7.1.6 of the VARIANT II Service Manual for installation
of the new column heater block. Note the following changes to the procedure.

• Remove the pre-heat coil from the old column heater before removing it from the
column heater unit.
• Re-install the pre-heat coil into the new column heater after securing it to the
column heater unit.

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VARIANT ™ II TURBO Hemoglobin Testing System

6.2 VSS Replacements

All VSS replacement procedures remain unchanged from the VARIANT II Service
Manual, except Figure 6-1 below replaces Figure 7-73.
Replacements

Figure 6-1: VSS Tube Hold Down Assembly

Section 6.2.1 below describes the replacement of the new tube hold down assembly
sensor and wiring.

6.2.1 Upgraded Tube Hold Down Sensor and Wiring

Figure 6-2 shows the components of the tube hold down sensor and wiring upgrade kit.

6-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

1. Wiring Assembly
2 2. Cable with Sensor
5
Bracket Assembly
3. Sensor Assembly
4. Screw Sets A (M3X6)
4 and B (M3X6-Stainless
Steel)
5. Tie Wraps

Replacements
1
3

Figure 6-2: VSS Tube Hold Down Sensor and Wiring Upgrade Kit

1. Turn off the power to the VSS and remove the power cord.
2. Remove the tube hold down assembly.
3. Remove the old wiring along with the photo sensor assemblies. (Figure 6-3)

1. Old Sensor Assembly 1


2 2. Old Sensor Assembly 2
3. Guide Rod
3

Figure 6-3: Removal of the Old Sensor Assemblies

4. Turn the lead screw manually until the block is at the bottom position. (Figure 6-4)

L70243200 Service Manual 6-3


VARIANT ™ II TURBO Hemoglobin Testing System
Replacements

To the bottom

Figure 6-4: Turning the Lead Screw

5. Secure the sensor bracket of the new cable assembly using the 2 stainless steel screws.
(Figure 6-5)

1. Cable
2. Sensor Bracket
3. Stainless Steel
Screws

3
1

Figure 6-5: Installing the Sensor Bracket

6-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

6. Secure the sensor unit using the 2 screws (M3X6). (Figure 6-6)

1. New Sensor
Assembly
2. M3X6 Screws

Replacements
2

Figure 6-6: Securing the New Sensor Assembly

7. Insert the end of the cable to the connector #5322. Push the connector housing to lock
the cable in place. (Figure 6-7)

Push

Insert

Figure 6-7: Inserting the Cable at the Connector

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VARIANT ™ II TURBO Hemoglobin Testing System

8. Secure the cable bracket using the 2 screws. (Figure 6-8)

Cable
Replacements

bracket

Two screws

Figure 6-8: Securing the Cable Bracket

9. Check the tension of the cable. It should be loose.


10. Turn the lead screw until the block is in the upper position with a gap between the block
and the head of the screw at the top. Verify that the cable is not binding anywhere.
Figure 6-9 shows the position of the cable with the block in the lowest and highest
positions.

Figure 6-9: Checking the Cable

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VARIANT ™ II TURBO Hemoglobin Testing System

11. Connect the new wiring assembly at #5320 on the sensor board. Place a tie wrap around
both the new wiring and the motor wiring. (Figure 6-10)

Replacements
Figure 6-10: Installing the New Wiring Assembly

Figure 6-11 shows the completed tube hold down assembly.

Figure 6-11: Upgraded Tube Hold Down Assembly

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VARIANT ™ II TURBO Hemoglobin Testing System

12. Re-install the tube holder assembly.


13. Perform the following alignments from Section 6 of the VARIANT II Service Manual.

• Front Rack Carrier Vertical Guide Plate (Section 6.5)


• Side Rack Guides (Conveyor Width) (Section 6.7
• Tube Holder Y (mechanical) (Section 6.12
• Needle Guide, X Axis (Section 6.15)
• Needle Y Axis at Sampling Position (Section 6.17)
• Rear Rack Carrier Home and Limit Positions (Section 6.21)
• Front Rack Carrier Home and Limit Positions (Section 6.22)
Replacements

• Tube Sensor (mechanical) (Section 6.23)


• Rear Rack Spinning Position (Section 6.24)
• Barcode Tube Position (barcode mechanical) (Section 6.25)
• Spin Head X and Y Positions (Section 6.26)
• Rack Sample Position (Section 6.27)
• Rack Barcode Position (Section 6.28)

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VARIANT ™ II TURBO Hemoglobin Testing System

7 Maintenance
This section contains the minimum requirements for performing annual preventive
maintenance on the VARIANT II TURBO. Any additional maintenance items can be
performed based on regional requirements. Refer to the VARIANT II TURBO Operation
Manual for daily, monthly and periodic maintenance procedures.

NOTE: This section assumes the system requiring maintenance has all of the

Maintenance
reliability upgrades to the hardware, current firmware and software.

7.1 Materials

Required Materials

2 Pump Maintenance Kits (P/N 270-2315)


Vespel Injection Valve Rebuild Kit (P/N 270-2169V)
1 mL Ito Syringe Plunger (P/N 270-2293)
5 mL Ito Syringe Plunger (P/N 270-2294)
Molybdenum based grease (e.g. Redline™ CV2)
Light Lithium grease (e.g. Lubriplate ™ DS-ES)
Light oil with Teflon™ (e.g. Triflow™)

Additional Materials as Needed*

Detector Lamp (P/N 270-0202)


Flow Cell Cleaning Kit (P/N 270-0197)
Sample Probe (P/N 220-0247)
Tube Mixer Gum Head (P/N 270-2088)

*Refer to the VARIANT II TURBO Maintenance Report in Section 7.5 for additional parts
that may need replacement. The part numbers can be found in Section 10 of the
VARIANT II Service Manual.

L70243200 Service Manual 7-1


VARIANT ™ II TURBO Hemoglobin Testing System

7.2 VCS

Safety

Turn off the VCS and remove the power cord from the back of the unit.

Detector

1. Clean the flow cell. Follow the package insert provided with the flow cell cleaning
Maintenance

kit. Replace the flow cell only as needed. Refer to VARIANT II Service Manual
Section 7.1.7 Detector/Flow Cell for the procedure.
2. Check the inlet and outlet tubing connections for leaks or damage. Clean and repair
as needed.
3. Check the lamp alignment. Refer to VARIANT II Service Manual Section 7.1.7
Detector/Lamp Assembly for details.
4. Check the detector board. Do NOT adjust the pre-amplifier outputs unless you are
prepared to perform a detector noise and drift test. Refer to VARIANT II Service
Manual Section 5.9 Detector Board Adjustment and Section 8.8.1 of this manual for
the procedures.

Degasser

Check the tubing connections for leaks. Clean and repair as needed.

Pumps

Refer to VARIANT II Service Manual Section 7.1.5 for pump component replacement
procedures.

1. Remove the pump tray. Refer to VARIANT II Service Manual Section 7.1.5 Pump
Unit/Motor Photo Sensor for details of the procedure.
2. Replace pistons, seals and bushings. Check valves, springs and other pump
components should only be replaced if defective.
3. Remove the front U section of the pump chassis. Remove the pump cam. Remove
the top 2 set screws, loosen the bottom 2 set screws, hold the back of the motor shaft
with an adjustable wrench and twist the cam off. DO NOT PRY IT OFF. If the cam
was difficult to remove, smooth off the shaft before replacing the cam.
4. Inspect crosshead rods. Clean and lubricate (light film of lithium based grease) if
contaminated. If the crosshead is scored it must be replaced along with a new linear
bearing. DO NOT remove the guide pin holder unless absolutely necessary.
5. Clean the thrust bearing and washers. Pack the thrust bearing and coat the washers
with a molybdenum-based grease.

7-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

6. Reinstall the pump cam. Restore it to the original position so an additional pockmark
will not be placed on the shaft. Make sure that the set screws over the flat side of the
shaft are centered on the flat and that the cam is fully seated against the pump chassis
prior to tightening the set screws.
7. Reassemble the pump.

Injection Valve (6 port)

Replace the rotor and stator face. Flush out the surrounding tubing if the rotor

Maintenance
shows disintegration.

NOTE: The rotor and stator face of the 7 port valve is only replaced or cleaned as
needed.

Syringe Assembly

1. Clean and then lubricate the lead screw with molybdenum-based grease.
2. Clean and then lubricate the guide rods with a light film of lithium-based grease.
3. Clean the syringe barrel and tip. Replace the syringe plunger if the tip is damaged.
4. Inspect the drive belt and replace if damaged.
5. Clean the optosensor with compressed air.
6. Check the fittings at the 3-way valve for leaks or damage. Clean and repair as
needed.

Cartridge Holder

1. Clean the inside with deionized water and a swab. Rinse well. Sonicate in deionized
water if possible to remove all dried residue. Replace the holder if the threads are
damaged.
2. Inspect the tubing to the detector. Replace if damaged or plugged.

NOTE: The cartridge to detector tubing can also be replaced annually based on
regional requirements.

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VARIANT ™ II TURBO Hemoglobin Testing System

Tubing

1. Inspect the piston backwash tubing. Replace if discolored.


2. Inspect all internal tubing for signs of leakage. Tighten or replace fittings as needed.

The following tubing can be replaced annually based on regional requirements:

Sample Delivery (P/N 270-2204)


Teflon Tube 1.58mm x 0.5mm (P/N 270-2137)
Maintenance

Teflon Tube 3.18mm x 1.5 mm (P/N 270-2138)

Cleaning

Clean all interior and exterior surfaces.

Miscellaneous

The components listed below should be inspected. Clean or replace all items as needed.

Purge Valves (Pumps A and B)


Doors and Latches (lubricate using Light oil with Teflon ™)
All fittings
All tubing internal and external
Level Sensors

Break-in

1. Reconnect the power cord and restart the VCS.


2. Using the service software to run the pumps, purge the pump and run against a back
pressure until the pressure is stable.
3. Check pump drive current, adjust as needed. Refer to Section 5 for details of the
procedure.

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VARIANT ™ II TURBO Hemoglobin Testing System

7.3 VSS

Safety

Remove the sample probe.

Dilution Chamber

1. Remove the dilution chamber and clean it thoroughly using household bleach. Rinse

Maintenance
thoroughly with deionized water.
2. Fill the syringe from a Flow Cell Cleaning Kit with deionized water and attach the
syringe, with the fittings, to one of the 3 threaded ports on the right side of the tower.
Push the water through the port. Repeat with the remaining ports.
3. Check all fittings for leaks and repair if needed.
4. Inspect Pinch Valves 3 through 7. Replace if damaged.
5. Inspect all tubing from the dilution chamber to the internal waste tank. Clean or
replace based on regional requirements. This includes the following:

L10 from Dilution Chamber to Back Panel (P/N 270-2022)

Silicone Waste Tubing from All Drain Ports through Pinch Valves 3, 4
and 7 to the Internal Waste Tank (P/N 270-2023, 270-2024 and 270-2025)

6. If tubing in the pinch valve was not replaced, reposition the old tubing so the valve
will open and close on a different position.
7. Using the VSS Service Software and a squirt bottle filled with deionized water,
verify that all drain lines evacuate properly. Use the following settings in the Manual
screen:

Valves 5, 6 Valve 7 Vacuum Pump Valve 3 Valve 4


Dilution Well Vacuum In Vacuum DW DP
Waste Port Vacuum In Vacuum DP DP
Wash Port Vacuum In Vacuum DP WP

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VARIANT ™ II TURBO Hemoglobin Testing System

Syringe Assembly

1. Turn off the power to the VSS and remove the power cord from the side.
2. Clean and then lubricate both lead screws with molybdenum-based grease.
3. Clean and then lubricate the guide rods with a light film of lithium-based grease.
4. Assess the amount of movement in the lead screw. If the movement is excessive
replace the lead screw and flange nut. Refer to the VARIANT II Service Manual
Section 7.1.10 for the procedure.
5. Inspect the drive belts. Replace if damaged.
Maintenance

6. Clean the optosensors with compressed air.


7. Inspect Pinch Valves 1 and 2. Replace if damaged.
8. Clean the syringe barrels. Replace both syringe plungers. Verify that the knurled
nuts securing the syringe plungers to the platforms contain lock washers. Install
them if missing.

Internal Waste Chamber

Clean the internal waste chamber. Inspect the tubing and fittings. Clean or repair as
needed.

Sampling Assembly

1. Clean and inspect the sample needle. Replace if damaged.

WARNING: The sample needle is very sharp. Use caution when handling to avoid injury.

2. Clean and then lubricate the lead screw with molybdenum-based grease.
3. Clean and then lubricate the 4 guide rods with a light film of lithium-based grease.
4. Test the movement of the lead screw. If the movement is excessive replace the lead
screw and flange nut.
5. Inspect the Y and Z drive belts. Replace if damaged.
6. Clean the optosensors with compressed air.
7. Inspect the fitting and tubing at the sample needle. Repair or replace based on
regional requirements (P/N 270-2021)

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VARIANT ™ II TURBO Hemoglobin Testing System

Mix Head Assembly

1. Clean the mix head. Replace the gum head if damaged.


2. Clean the face of the barcode reader using a water dampened soft cloth. Be careful
not to scratch the surface.
3. Clean and then lubricate the lead screw with molybdenum-based grease.
4. Clean and then lubricate the guide rods with a light film of lithium-based grease.
5. Inspect the Z and Mix drive belts. Replace if damaged.
6. Clean the Home and Hold optosensors with compressed air.

Maintenance
Rack Transport

1. Clean the 2 front and 4 rear opto and tube sensors with compressed air.
2. Check the rack drives for smooth motion with the power off. Watch for loose
pulleys. Repair if damaged.
3. Clean the left and right conveyor belts with deionized water or isopropyl alcohol.

Tube Hold Down Assembly

1. Clean the tube hold down plate and needle guide.


2. Clean and then lubricate the lead screw with molybdenum-based grease.
3. Clean and then lubricate the guide rods with a light film of lithium-based grease.
4. Inspect the drive belt. Replace if damaged.
5. Clean the Home and Hold optosensors with compressed air.

Alignments

1. Reinstall the sample probe. Attach the power cord and turn on the power.
2. VSS Alignment procedures are found in Section 6 of the VARIANT II Service
Manual. Check the following alignments and adjust if needed

Spin Head Vertical Alignment (6.9)


Needle Guide X-axis (6.15)
Needle Y-axis at Wash Port (6.16)
Needle Y-axis at Sampling Position (6.17)
Rear Rack Carrier Home and Limit Positions (6.21)
Front Rack Carrier Home and Limit Positions (6.22)
Rack Sample Position (6.27)

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VARIANT ™ II TURBO Hemoglobin Testing System

7.4 Performance Verification

1. Set up a sample run using controls and previously analyzed patient samples.
2. Assess the VSS alignments, dilution performance and pump pressure stability during
the run. Make all required adjustments if any component is not functioning properly.
3. Assess the quality of the chromatogram including sample areas, QC values and
retention times. Correct for any deficiencies.

7.5 VARIANT II TURBO Maintenance Checklist


Maintenance

Complete a VARIANT II TURBO Maintenance Report and attach a copy of the


performance verification results. Leave a copy at the customer site. A copy of this
document is on the following page. An electronic version can be obtained from
CSD Technical Support or your regional technical support group.

7-8 Service Manual L70243200


VARIANT II TURBO Maintenance Report

Date: Site: City:


State: Country: S/N: Assays:
VCS Firmware Version: VSS Firmware Version: CDM Version: Injection Count
‰ Required as part of PM As Needed ~ Lubricants Used: M = Molybdenum L = Lithium T = Light oil with Teflon
Component Replace Clean & Inspect Lubricate
Detector Flow Cell ‰
Pump A / B Cam & Thrust Bearings A / B ‰‰ / ‰‰ M‰‰ ‰‰
Seals 1 / 2 / 3 / 4 ‰/‰/‰/‰
A Left =1 Bushings 1 / 2 / 3 / 4 ‰/‰/‰/‰
A Right=2 Pistons 1 / 2 / 3 / 4 ‰/‰/‰/‰
B Left=3 Push Rod & Cam Follower 1 / 2 / 3 / 4 ‰/‰/‰/‰ L~~ ~~
B Right=4 Pump Heads 1 / 2 / 3 / 4 ‰/‰/‰/‰
Wash heads 1 / 2 / 3 / 4 ‰/‰/‰/‰

Valves Rotors (6 port / 7 port) ‰/~ /‰


& Mixer 3-way valve fittings/ Mixer ‰/‰
VCS Syringe Syringe Tip ‰
Assembly Lead Screw / Guide rails ‰/‰ M‰ / ‰L
Cart. Holder Cartridge Holder ~ ‰
VCS System Purge Valves A / B ‰/‰
Doors and Latches ‰/‰ T~ ~
Fittings / Tubing ‰/‰
Level Sensors, Reagent and Waste ‰/‰
Case Internal / External ‰/‰

Computer Interior / Exterior ‰/‰


Chkdsk-Temp Files / Disk Space ‰/‰
Printer Interior / Exterior ‰/‰

VSS Syringe Syringe Plungers Diluent / Sample ‰/‰


Assembly Lead Screws / Guide rails ‰‰ / ‰‰ M‰‰/‰‰L
Sensor / Sample delivery tube L1 ‰/‰
Sample Head Y Belt / Guide rails ‰/‰ / ‰L
Assembly Z Lead Screw / Guide rails ‰/‰ M‰ / ‰L
Needle / Sensors (Y, Z) ~ ‰ / ‰‰
Needle Corral Vertical Rods ‰ T‰
Tube Holddown Z Lead Screw / Guide rails ‰/‰ M‰ / ‰L
Sensors (home, hold) / Belt ‰‰/‰
VSS Mixer Assy Sensors (home, hold) / Belts (Z, mix) ‰‰ / ‰‰
Z Lead Screw / Guide rails ‰/‰ M‰ / ‰L
Barcode Head ‰
Rack Trans & Rack motion (RR, LR, LF, RF) ‰/‰
Conveyors Belts L/R ‰/‰
VSS Waste Dilution Chamber Assembly / Waste Tubing / ‰/‰/‰
System Internal Tank ~~~~~~~ ‰‰‰‰‰‰‰
Pinch Valve Tubing (V1-V7)
VSS System Doors / Latches / Fittings / Tubing ‰/‰/‰/‰ T~/~/ /
Case Internal / External ‰/‰

Performance Pre PM Post PM Verification

Pressure Reading A / B _____ / _____ _____ / _____


Fluctuation A / B _____ / _____ _____ / _____
Pump Purge A / B and Leak Check ‰/‰ ‰/‰
Slope & Intercept (factor) _____ / _____ _____ / _____
Retention Times: A1c & Ao or F & A2 or Non-Ghb & Ghb _____ / _____ _____ / _____
Baseline Quality _______________________ ______________________

L70243200 Service Manual 7-9


Comments

7 - 10 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8 Troubleshooting
This section of the VARIANT II TURBO Service Manual contains flow charts, guidelines
and error codes for troubleshooting the VARIANT II TURBO. Examples of acceptable
chromatography are included as a reference when evaluating baselines, peaks and retention
times.

8.1 Chromatography Review

Troubleshooting
The following peaks are contained in the peak table of the VARIANT II TURBO
Hemoglobin A1c test file:

• A1a
• A1b
• F
• LA1c (labile A1c)
• CHb (carbamylated hemoglobin)
• A1c
• Ao
• Variant Window (contains variant hemoglobins not S or C)
• S
• C

Figure 8-1 shows an example of an acceptable HbA1c chromatogram.

L70243200 Service Manual 8-1


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-1: Acceptable Hb A1c Chromatogram

8-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8.2 Variant Hemoglobin Chromatography

Figure 8-2 through 8-5 show examples of patient samples containing some common
variant hemoglobins in the heterozygous state (patient has Hb A plus the variant). These
examples are reportable Hb A1c results; however, if a Variant, S or C window is seen with
no A1c or Ao peaks present, the sample is homozygous for the variant (no Hb A present)
and the result cannot be reported.

Troubleshooting
Use caution when reviewing results with a Variant, S or C window. Their presence may
also indicate a retention time issue where all, or part, of the Ao peak is coming off too late
and is misidentified or can be carryover from a previous sample containing the variant
(Figure 8-6). If Hb A1c is present, there will always be an Ao peak also present.
True variant hemoglobins will normally be greater than 20%. Refer to Section 8.3 for
troubleshooting retention time issues.

L70243200 Service Manual 8-3


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-2: Heterozygous Hb E

8-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Troubleshooting

Figure 8-3: Heterozygous Hemoglobin D

L70243200 Service Manual 8-5


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-4: Heterozygous Hemoglobin S

8-6 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Troubleshooting

Figure 8-5: Heterozygous Hemoglobin C

L70243200 Service Manual 8-7


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-6: Hemoglobin C Carryover

8-8 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8.3 Retention Times

The current retention times for each assay can be found in the Setup/Test screen in CDM
3.6T.

Early Retention Times

Figure 8-7 shows an example of an early A1c peak misidentified as CHb.

Troubleshooting

Figure 8-7: Misidentified A1c Peak

L70243200 Service Manual 8-9


VARIANT ™ II TURBO Hemoglobin Testing System

Use the flow chart in Figure 8-8 to troubleshoot early A1c and Ao retention times.
Troubleshooting

Figure 8-8: Early Retention Time Flow Chart

8-10 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Late Retention Times

Use the flow charts in Figures 8-9 and 8-10 to troubleshoot late A1c and Ao retention times.

Troubleshooting

Figure 8-9: Late A1c Retention


Time Flow Chart

L70243200 Service Manual 8-11


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-10: Late Ao


Retention Time Flow Chart

8-12 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8.4 Area Counts

Refer to the Setup/Sample Types screen in CDM for the acceptable area count
range.

When evaluating total area count issues consider what type of sample is being
affected. Samples that are pre-diluted and mixed properly should always have an
area within the specified range. Area counts out of range consistently for pre-
diluted and primary tubes are related to issues in the common pathway for both

Troubleshooting
samples. Area counts out of range that affect only primary tubes may point to an
issue with the dilution process of patient samples.

Low Area Count

1. Patient sample related:

Insufficient Sample Volume


Clotted Sample
Low Patient Hematocrit (low red cell volume in sample)

2. Primary sample tubes affected:

Air in the VSS Diluent Syringe (5 mL)


Faulty Pinch Valve (PV 1 or PV2)
Needle Depth in Dilution Well Too High
Needle Depth for Primary Tubes Too High
Inadequate Tube Venting
"Sloppy" Sample Syringe (screw shaft or loosened bolt at top)

3. Pre-diluted samples affected:

Needle Depth for Pre-diluted Samples Too High


Improper Sample Rack Alignment (needle piercing through side of vial)

4. Pre-diluted and primary sample tubes affected:

Occluded Sample Loop


Leak in Sample Line Fitting
Air in Sample Line
Leak in Dilution Well Drain Line or Fitting
Faulty Pinch Valve (PV1, PV2, or PV3)
Leak in Sample Transfer Line or Fittings (VSS to VCS)
Leak at Sample Line into Injection Valve (6 port)
Leak at VCS Syringe
Leak at Cartridge Holder
Leak at Detector Inlet Line
Light Level of Detector not Aligned Properly (lamp too high or too low)

L70243200 Service Manual 8-13


VARIANT ™ II TURBO Hemoglobin Testing System

Faulty 3 way solenoid valve

High Area Count

1. Patient sample related:

Patient with High Hematocrit (too many red cells in sample)

2. Primary sample tubes affected:


Troubleshooting

Sample Not Mixed Properly


Needle Depth for Primary Tubes Too Low
Faulty VSS Syringe Pump (5 mL)
Inadequate Drain of Dilution Chamber
PV3 or PV7 not Functioning Properly
Clogged L11 Tubing
Clogged Dilution Chamber
Pump Vacuum not Functioning Properly

3. Pre-diluted and primary sample tubes affected:

Inadequate Wash of Sample Needle

8-14 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8.5 Error Codes


Explanation of Error Code Chart

Detection: Brief description of the problem


Activity:
• Active – User notification, system continues to run
• Inactive – System stops after current action

Troubleshooting
• Inactive (stop immediately – System stops immediately
Recover: Action by user to recover the system

8.5.1 VCS Error Codes

Error Code Device Error Description


0x07 Injector Sampler syringe home position error
Detection Syringe can not detect the home position sensor.
Activity Inactive (stop immediately)
Recovery Check the syringe mechanically and electronically.
Correct the error and reboot the VCS. Verify that the
syringe moves properly on initialization.
0x08 Injector Sampler syringe movement error
Detection When the syringe returns to the home position sensor,
the deference between the actual moving pulses count
and the calculated count value is determined. If these 2
values do not match an error is generated.
Activity Inactive (stop immediately)
Recovery Check the syringe mechanically and electronically.
Correct the error and reboot the VCS. Verify that the
syringe moves properly on initialization.
0x09 Injector Sampler injection valve does not move to Load/Inject position
Detection Injection valve can not move to Load/Inject position
within the defined time period.
Activity Inactive (stop immediately)
Recovery Check the injector both mechanically and
electronically. Correct the error and reboot the VCS.
Verify that the injector moves properly on initialization.
0x0B Injector Cartridge thermomodule temperature is out of limits
Detection Allowable range is within +/- 0. 5 deg C of set point.
Activity Inactive
Recovery Verify that enough time has elapsed to equilibrate a
temperature change. Check the column heater block
temperature if it does not stabilize. Repair or adjust as
needed.
0x0C Pump Degasser chamber vacuum level is out of limits
Detection Vacuum level is over allowable range.
Activity Inactive
Recovery Check the degasser and repair if needed.

L70243200 Service Manual 8-15


VARIANT ™ II TURBO Hemoglobin Testing System

Error Code Device Error Description


0x0D Injector Column over heat
Detection Column temperature shows less than 10 deg C or more
than 55 deg C.
Activity Inactive (stop immediately)
Recovery Check the temperature in the column heater block.
Repair or adjust as needed.
0x0F Pump Pump A error
Detection Pump motor can not do appropriate turning.
Troubleshooting

Activity Inactive (stop immediately)


Recovery Check and repair Pump A.
0x10 Pump Pump B error
Detection Pump motor can not do appropriate turning.
Activity Inactive (stop immediately)
Recovery Check and repair Pump B.
0x11 Pump System pressure is above high pressure limit
Detection The pressure is over the defined High Pressure Limit.
Activity Inactive (stop immediately)
Recovery Replace the cartridge and/or guard cartridge and check
the pressure. If still high check the tubing from the
pump to the guard cartridge.
0x12 Pump System pressure is below low pressure limit
Detection The pressure in the liquid lines is outside defined Low
Pressure Limit.
Activity Inactive (stop immediately)
Recovery Check for leaks, verify analytical cartridge is in place,
check for air in the system.
0x13 Injector Waste tank is full
Detection Fluid level in the waste tank is too high.
Activity Active
Recovery Empty the waste tank.
0x14 Detector Detector lamp failure
Detection Detector auto zero can not finish within the defined
time period. Allowable range is 20mV+/-5mV.
Activity Inactive (stop immediately)
Recovery Check lamp for burnout or check the electrical circuit.
0x16 Pump Sampler 7 port valve movement error
Detection 7 Port valve can not move to T-Mixer, D-Mixer
and Purge valve position within the defined time
period
Activity Inactive (stop immediately)
Recovery Check the valve mechanically and electronically.
0x17 Pump Pump A and B error at the same time
Detection Pump motor can not do appropriate turning
Activity Inactive (stop immediately)
Recovery Repair the pumps

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VARIANT ™ II TURBO Hemoglobin Testing System

Error Code Device Error Description


0x18 Pump Dynamic mixer moving error
Detection Dynamic mixer can not do appropriate rotation
Activity Inactive (stop immediately)
Recovery Clean and check the dynamic mixer.
0x19 Pump Fan moving error
Detection Fan can not move
Activity Inactive (stop immediately)
Recovery Check and repair the fan.
0x1A Detector A/D converter error

Troubleshooting
Detection Detector A/D converter has malfunction.
Activity Inactive (stop immediately)
Recovery Check the detector, detector board, flow cell and
perform an autozero.
0x54 Pump Internal data error
Detection Communication problem occurred between Main CPU
and VCS.
Activity Inactive (stop immediately)
Recovery Check cables. Reboot VCS and/or pc.

L70243200 Service Manual 8-17


VARIANT ™ II TURBO Hemoglobin Testing System

8.5.2 VSS Error Codes

Error Code Device Error Description


0x20 Sampler Sampler Y-axis home position error
Detection Y-axis can not detect the home position sensor.
Activity Inactive (stop immediately)
Recovery Check sampling arm mechanically and electronically.
Reboot the VSS and verify movement during
initialization.
0x22 Sampler Sampler Z-axis home position error
Troubleshooting

Detection Same as Y-axis error


Activity Inactive (stop immediately)
Recovery Same as Y-axis error
0x23 Sampler Sampler Z-axis lower sensor position error
Detection Z axis can not correctly detect the lower position
sensor.
Activity Inactive (stop immediately)
Recovery Check the Z movement mechanically and
electronically. Reboot the VSS and verify movement
during initialization.
0x24 Sampler Sampler syringe#1 home position error
Detection Syringe#1 can not detect the home position sensor.
Activity Inactive (stop immediately)
Recovery Check the syringe mechanically and electronically.
Reboot the VSS and verify movement during
initialization.
0x26 Sampler Sampler syringe#2 home position error
Detection Syringe#2 can not detect the home position sensor.
Activity Inactive (stop immediately)
Recovery Check the syringe mechanically and electronically.
Reboot the VSS and verify movement during
initialization.
0x28 Rack Rack tube mixer Z-axis home position error
Detection Tube mixer Z-axis can not detect the home
position sensor.
Activity Inactive (stop immediately)
Recovery Check the mix head mechanically and
electronically. Reboot the VSS and verify
movement during initialization.
0x2B Sampler Vacuum tank is full
Detection Fluid level in the vacuum tank is too high.
Activity Inactive (stop immediately)
Recovery Empty the vacuum tank and reboot the VSS.

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VARIANT ™ II TURBO Hemoglobin Testing System

Error Code Device Error Description


0x2C Sampler Sampler tube holder home position error
Detection Tube holder can not detect the home position
sensor.
Activity Inactive (stop immediately)
Recovery Check the tube holder mechanically and
electronically. Reboot the VSS and verify
movement during initialization.
0x2D Sampler Sampler tube holder movement error

Troubleshooting
Detection Tube holder can not detect the tube hold position.
Activity Inactive (stop immediately)
Recovery Check the tube holder mechanically and
electronically. Reboot the VSS and verify
movement during initialization.
0x2E Rack Barcode reading error
Detection Barcode reader can not read the barcode data.
Activity Active (Warning only)
Recovery After Error message is send once, it automatically
recovers from the error.
0x2F Rack Front rack carrier home position error
Detection Front rack carrier can not detect the home position
sensor.
Activity Inactive (stop immediately)
Recovery Check the front rack carrier mechanically and
electronically. Reboot the VSS and verify
movement during initialization.
0x30 Rack Front rack carrier movement error
Detection Front rack carrier can not detect the limit position
sensor.
Activity Inactive (stop immediately)
Recovery Check the front rack carrier mechanically and
electronically. Reboot the VSS and verify
movement during initialization.
0x31 Rack Rear rack carrier home position error
Detection Rear rack carrier can not detect the home position
sensor.
Activity Inactive (stop immediately)
Recovery Check the rear rack carrier mechanically and
electronically. Reboot the VSS and verify
movement during initialization.
0x32 Rack Rear rack carrier movement error
Detection Rear rack carrier can not detect the limit position
or the stop position sensor.
Activity Inactive (stop immediately)
Recovery Check the rear rack carrier mechanically and
electronically. Reboot the VSS and verify
movement during initialization.

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VARIANT ™ II TURBO Hemoglobin Testing System

Error Code Device Error Description


0x33 Rack No sample rack error
Detection When Move Rack (or Move Rack To Start
Position) event is executed, Rack sensor can not
detect the rack.
Activity Active (TET will end.)
Recovery Place a sample rack on the belt and restart.
0x36 Rack Tube sensor error
Detection Tube sensor is always on. It will check twice for
Troubleshooting

the presence of a tube. It the 2 checks do not


match the error occurs.
Activity Inactive (stop immediately)
Recovery Check the sensor and reboot the VSS.
0x37 Rack/ Door open error
Sampler Detection Hardware Interrupt Stop and Door switch changed
to OPEN. Needle Cover.
Activity Inactive (stop immediately)
Recovery Replace cover.
0x38 Rack/ Fan stop error
Sampler Detection Fan switch change to NG.
Activity Active (Warning only. )
But VSS can not run for very long. Sample run
should be abort after current sample.
Recovery Check the fan and repair if needed.

0x39 Rack Rack Sensor Error


Detection Rack sensor detects rack when there is none
present
Activity Inactive (stop immediately)
Recovery Repair rack sensor or belt conveyer.
0x3A Rack Barcode Reader Setting Error / Hardware Error
Detection Error occurs if a symbology is detected that is
unrecognizable, the barcode can’t be read or there
is a communication failure with the pc.
Activity Active (Warning only)
Recovery Check barcode and/or reader.

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VARIANT ™ II TURBO Hemoglobin Testing System

8.5.3 General Error Codes

Error Code Error Description


0x50 Invalid Command. Warning about invalid command executed.
Parameter Out Of Range. Warning about illegal parameter in the
0x51
execute command. The message will be sent once.
Invalid Status (Device Busy). Sends an execute command or load
0x52 TET during reset or Zero operation. The message will be sent
once.

Troubleshooting
TET Loading Error. Invalid TET sent by CDM will cause moving
0x53 to a TET_NONE state not before sending at least one status
message with TET_LOADING state.
0x60 EEPROM load/write error

L70243200 Service Manual 8-21


VARIANT ™ II TURBO Hemoglobin Testing System

8.6 Self Diagnostics

The system will go through an initialization sequence upon power up. If any part of this
self diagnostic fails, an error message will be generated in CDM.

8.6.1 VCST Self Diagnostic Sequence and Flow Chart

The following sequence is performed at power up. If an error occurs, a message is sent to
Troubleshooting

CDM. Figure 8-11 shows the flow chart of this sequence.

1. RAM check. Data is written and read in RAM area. If an error occurs, an audible
alarm will sound. In this case, a report will be not be sent to CDM.
2. Syringe movement check. Syringe moves down and then up to the home position.
Home position sensor output is checked.
3. 6-Port valve unit movement check. 6-port valve rotates from Load to Inject, and
position sensor output is checked.
4. 7-Port valve unit movement check. 7-port valve rotates to Purge from Dynamic,
and next to T-mixer position. Position sensor output is checked.
5. FAN movement check. The moving signal from the fan is checked.
6. Pump unit movement check. Pump A and B move at flow rate of 1 mL/min for 10
seconds, and movement sensor output is checked.
7. Dynamic mixer movement check. Dynamic mixer moves, and movement sensor is
checked.

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VARIANT ™ II TURBO Hemoglobin Testing System

Power On

RAM Check

Error: Alarm Only (can’t communicate)

(Communication Begins)

Troubleshooting
(HW_BUSY)
Syringe Down (1800 pulses)
NG
NG
Syringe Home
NG
VCST sends error code to CDM
6 Port Load Position
NG

6 Port Inject Position CDM displays error message


NG

7 Port Dynamic Mixer Position Self Diagnostics stops


NG

7 Port Purge Position


Check Hardware and Correct Problem; Reinitialize
NG

7 Port T-mixer Position


NG

Fan Movement Signal Check


NG

Pump A and B Movment (flow rate 1 mL/min)

NG

Pumps Stop
NG Figure 8-11:
VCST Self
Diagnostic
Dynamic Mixer Check
Flow Chart
NG

(TET NONE)

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VARIANT ™ II TURBO Hemoglobin Testing System

8.6.2 VSST Self Diagnostics Sequence and Flow Chart

The system will go through an initialization sequence upon power up. If any part of this
self diagnostic fails, an error message will be generated in CDM. For memory errors, the
VSST will sound an alarm and will not be able to communicate a message to CDM.
Figure 8-12 shows the flowchart for this sequence.

1. RAM check. Data is written and read in RAM area. When an error occurs, an audible
alarm will active. In this case a report will be not being sent to CDM.
Troubleshooting

2. ROM check. Checks the checksum that is stored in the EEPROM. When the stored
checksum and the recalculated checksum are different, an audible alarm will active. In
this case, a report will not be sent to CDM.
3. Spin head movement check
• The spin head goes down and up, and then the home position sensor output is
checked.
• Check if both the home sensor and the hold sensor exist in the same time.
• Check the moving pulses when it goes to home.

When a malfunction of the spin head is detected, a status will report to CDM.

4. Rack rear carrier movement check. The rear carrier goes to home, spinning, sampling
and limit positions, and then returns to home position. In each position, the sensor
output is checked. When a malfunction of the rear carrier is detected, an error will
report to CDM.
5. Rack front carrier movement check. The front carrier goes to home and to limit
position. In each position, the sensor output is checked. When a malfunction of the
front carrier is detected, an error will report to CDM.
6. Barcode reader check. The barcode reader turns itself on and then sends the result to
VSS main CPU, and then the result is checked. When a malfunction of the reader is
detected, an error will report to CDM.
7. Right and Left Conveyer, and Rack sensors check.
• Left Conveyer moves to rear and then checks Front-Left rack sensor.
• Right Conveyer moves to rear and then checks Front-Right rack sensor.
• Left Conveyer moves to front and then checks Rear-Left rack sensor.
• Right Conveyer moves to front and then checks Rear-Right rack sensor.

When a malfunction of the rack sensors or of the conveyers is detected, an error will
report to CDM computer.
8. Tube holder movement check.
• The tube holder goes down and up, and then the home position sensor output
is checked.
• Check if both the home sensor and the hold sensor exist in the same time.
• Check the moving pulses when it goes to home.

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VARIANT ™ II TURBO Hemoglobin Testing System

When a malfunction of the holder is detected, an error will report to CDM.

9. Needle Z axis movement check


• The needle Z axis goes down and up, and then the home position sensor
output is checked.
• Check the moving pulses when it goes to home.
• The needle Z axis goes up to the Z lower sensor after prime step, the lower
position sensor output is checked. If this checking is no problem, the Z axis
will go up to home.

Troubleshooting
When a malfunction of the Z axis is detected, an error will report to CDM.

10. Needle Y axis movement check


• The needle Y axis goes to front and to home, and then the home position
sensor output is checked.
• Check the movement pulses when it goes to home.

When a malfunction of the Y axis is detected, an error will report to CDM.

11. Syringe units movement check


• The syringes go down and up, and then the home position sensor output is
checked.
• Check the movement pulses when it goes to home.

When a malfunction of the syringe unit is detected, an error will report to CDM.

VSST Self Diagnostic Flow Chart

If any check fails, the system goes back to the Restart point and begins the sequence again.
If it fails after 3 tries, the system sends an error code to CDM and a message is displayed.

L70243200 Service Manual 8-25


VARIANT ™ II TURBO Hemoglobin Testing System

Power ON

RAM Check
Error: Alarm Only

EEPROM Check
Error: Alarm Only
Troubleshooting

Sampler Movement Check Rack Movement Check


(Retry Counter = 3) (Retry Counter = 3)
(HW_Busy) (HW_Busy)
(Communication Start) (Communication Start)

Restart Restart

Needle Z Axis Spin Head (Home)

NG NG

Needle Y Axis (Waiting until Z and Holder go to Home)

NG

Tube Holder (Home) Conveyer and Rack Sensor Check


NG
NG

Syringe 1 Rear Carrier


NG
NG

Syringe 2 Spin Head (Moving, Sensor)

NG NG

Prime (with Z lower sensor check) Front Carrier


NG
NG

(Waiting until end of rack check) Barcode Reader

NG

Tube Holder (moving and sensor) Normal


TET_NONE
NG

TET_NONE Figure 8-12:


VSST Self
Diagnostic
Flow Chart

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VARIANT ™ II TURBO Hemoglobin Testing System

8.7 Timing Chart

Figure 8-13 shows a combined timing chart for the TURBO VCS and VSS.

Troubleshooting

Figure 8-13: TURBO Timing Chart

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VARIANT ™ II TURBO Hemoglobin Testing System

8.8 Detector Troubleshooting

Baselines on all chromatograms should be relatively flat and the tracing should be smooth.
If they are not, check the following:

• All tubing connections are intact and properly connected


• Verify there is no air in the detector by performing a flush of the detector.
Troubleshooting

The flow chart in Figure 8-14 can be used if neither of the above are found to be the cause
of the problem.

8-28 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Troubleshooting
Section 8.8.1

Figure 8-14:
Detector Figure 8-21
Troubleshooting
Flow Chart

L70243200 Service Manual 8-29


VARIANT ™ II TURBO Hemoglobin Testing System

8.8.1 Detector Noise Test

The Detector Noise Test is a field service diagnostic tool that is used to rule out detector
issues when troubleshooting. This procedure is also applicable to the VARIANT II
System.

NOTE: It is extremely important to follow the procedure correctly and verify


that the sample fluid path is clean from the dilution chamber in the VSS
through the flow cell in the VCS, all fittings are intact and there is no air in the
Troubleshooting

system.

Required Materials

Flow Cell Cleaning Kit (P/N 2700197)


VII A1c, Beta Thal, GHb or VII TURBO cartridge and buffers
Sample Rack with no rack adapters
5 Non-barcoded Microvial Adapters with Microvials
1 Stop Tube
1 3.5 inch blank, formatted floppy disc
Noise Test Spreadsheet (noise.xls)

NOTE: The Noise Test Spreadsheet is available from CSD Technical Support
or your regional support group.

1. Follow the procedure in the Flow Cell Cleaning Kit to thoroughly clean the flow cell.
It is not necessary to re-clean the flow cell if it was done on the same day for a
Detector PCB adjustment.
2. Open CDM. Select SETUP/Test. Change the test to Noise for VII or Noise_T for
TURBO. Acknowledge the message about installing new buffers and cartridge.
Select the radio button for cartridge and then buffers and verify that each has a line in
use.

NOTE: VCS Service Software must be closed before opening CDM.

NOTE: If GHb cartridge and buffers are to be used, the NoiseGHb tss file must
be used. It is available from CSD Tech Support or your regional technical
support group and must be copied into the CDM database using
D:\CDM35\Copytest.exe. Make sure an unused test is selected in CDM before
copying the NoiseGHb test to avoid corrupting the current test lot number
information.

3. Install a cartridge in the cartridge holder. If running the NoiseGHb test, use an old
GHb cartridge. A new GHb cartridge may get damaged while running the noise test
due to the high flow rate.
4. Open the MAINTAIN/Instruments screen and prime Buffer B (100% B) at a flow
rate of 2.0 mL/min for 5 minutes.

8-30 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

5. Observe the Light Level reading in the Detector field of the screen while Pump B is
running. The reading should be approximately 0.02V. Select Zero 20mV on the
screen to zero the detector. If the light level reading drifts down from 0.02V repeat
Zero 20mV until the level stabilizes.
6. While Pump B is running, select the Monitor option at the top of the screen. Select
Start and adjust the scaling so that the screen shows the detector output voltage +
0.002 V. Monitor the baseline to verify that it is flat. Select Stop when the pump
stops. If the baseline is ramping or goes off scale when the pump is stopped, it
indicates air in the flow cell. Remove the air before proceeding to the next step.
7. Repeat Step 4 above using Buffer A (0% B).

Troubleshooting
8. Place the 5 non-barcoded microvial adapters in the sample rack. Fill 5 microvials
with Buffer A and place them in the microvial adapters. Place a stop tube after the
last adapter.
9. Select RUN/Worklist and start the run.
10. Select the Graph option. When the first sample trace starts to appear on the graph,
change the scale in order to place the trace in the middle of the graph. The scale
minimum should be 1 mV below the trace and the maximum 1 mV above the trace.
Select Set Scale on the screen to make the appropriate changes. Make the changes to
the scale permanent by selecting Yes when the screen appears. Failure to make these
changes causes the printed scaling to be off.
11. Save the Run Summary in order to obtain the injection numbers.
12. Export the raw data from the injections run to the floppy disc.
a. Place the floppy disc in the floppy drive (A:\).
b. Open Windows Explorer by right clicking on the Start button at the bottom
of the screen and selecting Explore.
c. Locate D:\CDMxx\RAWDATA.exe and start it by double clicking.
d. Enter the following information in the CDM Extract Raw Data screen
(Figure 8-15).

Figure 8-15: RAW DATA.exe Screen

L70243200 Service Manual 8-31


VARIANT ™ II TURBO Hemoglobin Testing System

• Output Path: Select the "a" drive


• Instrument: Select the instrument the samples were run on
• From Inj#: Enter the first injection number from the printouts
• To Inj#: Enter the last injection number from the printouts
• Save As: Select Text File (Raw)

13. Select Extract RAW file(s). When the data is written to the floppy disc, a message
will appear indicating the process is complete. Select OK and then Exit on the
screen.
Troubleshooting

14. Remove the floppy disc from the VII computer and place it into the floppy drive of a
computer that has the Noise.xls file loaded.
15. Open the noise test spreadsheet and select Enable Macros. The file will be Read
Only.
16. Select the buffer system that was used (e.g. V2 A1c). Figure 8-16 shows the
spreadsheet screen.

Figure 8-16: Noise Test Spreadsheet

17. Select Start Noise Test.


18. Enter the serial number of the instrument used. Verify the selected test is correct.
Select the raw file to be analyzed. The graph will automatically be plotted and the
calculated data displayed in the Results field. The Pass or Fail box will indicate
whether the noise test for the selected injection number passed or failed. If the test
failed, a box will automatically appear to the right of the graph indicating the possible
reasons for failure. If the average level of the detector is below 15mV or above

8-32 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

25mV, either the jumper was not returned to its proper position on the board or the
detector was not zeroed prior to the test. Correct the problem and repeat the noise
test.
19. Continue analyzing the data by selecting Start Noise Test again. Select Yes to
continue and repeat Step 17 for the remaining injections. Look for consistency
between the traces. If they are not similar, or if the later tests fail, repeat the Noise
Test with fresh Buffer A. If these do not show improvement, additional repair of the
detector is required.
20. Once the noise test is complete, set the test back to the assay to be run. If GHb was
used, remove the old cartridge and replace it with a new cartridge.

Troubleshooting
8.8.1.1 Acceptable Noise Tests

Figures 8-17 through 8-19 show a variety of passed noise tests. Figure 8-19 shows
slight Fuzz (line not smooth) in the trace. This can be caused by a small bubble or
debris in the flow cell. Remove the bubble or debris and repeat the noise test.

Figure 8-17: Ideal Noise Test Result

L70243200 Service Manual 8-33


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-18: Acceptable Noise Test

Figure 8-19: Passed with Slight Fuzz

8-34 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

8.8.1.2 Failed Noise Test

The following messages will appear next to the tracing in the spreadsheet if a noise
test fails.

NOTE: Fuzz refers to a line that is unstable or lacks definition (not smooth).

Gradient Noise

Troubleshooting
Gradient Noise >100 mV? = wrong inj #.
Gradient Noise drops with each successive injection? = dirty dilution well or sample
line swaging issue.
Gradient Noise stable, but above limit? = try a new lamp or optic bench (in that
order), re-balance and re-test

Fuzz

Fuzz is almost always something in the flow cell, usually air. If it differs across the
trace, then there is also a pump issue (noisy 0 to 80 seconds = Pump A, 40 to 130
seconds = Pump B). Purge the flow cell and pump(s) as required and re-test.

Combo

Look for reproducible “3 hump” patterns. If trace changes markedly from injection
to injection, lamp is dying. Replace lamp, rebalance and re-test.

Drift

Drift of 50 to 100 mV, dropping slowly = lack of thermal equilibration. Cover


detector and VCS, re-test. New lamps need at least 30’ to stabilize.
Drift >100 mV and stable test to test = bad lamp. Replace lamp, re-balance, re-test.
Failing that, replace detector PCB or detector.

Figure 8-20 shows a failed noise test with high drift.

L70243200 Service Manual 8-35


VARIANT ™ II TURBO Hemoglobin Testing System
Troubleshooting

Figure 8-20: Failed with High Drift

Refer to the Noise Test Flow Chart in Figure 8-21 for troubleshooting a failed noise
test. Once servicing is complete, repeat the Noise Test.

NOTE: An unstable lamp can adversely affect noise test results. Verify that the
lamp was powered on for the appropriate amount of time before running or
repeating a noise test. Refer to Section 8.5.1.3 Lamp Stabilization for details.

8-36 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Figure 8-21:
Noise Test
Flow Chart

Troubleshooting

L70243200 Service Manual 8-37


VARIANT ™ II TURBO Hemoglobin Testing System

8.8.1.3 Lamp Stabilization

Lamp stabilization is affected by the following factors:

• Temperature at power up
• Age of the lamp

The chart in Figure 8-22 shows the differences in drift between the old lamp on a
Troubleshooting

chromatographic station and a newly installed lamp immediately, and after 2 days.
Based on this data, it is important to allow adequate time for thermal equilibration (up
to 40 minutes) from a cold start up before performing a noise test. New lamps may
require additional time.

NOTE: All other parameters (fuzz, gradient noise, combo) were stable on both
lamps from the beginning.

Figure 8-22: Lamp Stability Drift Comparison

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VARIANT ™ II TURBO Hemoglobin Testing System

9 Spare Parts
9.1 TURBO Upgrade Parts

The following tables show the parts required to upgrade a VARIANT II to a VARIANT II
TURBO and also required reliability parts. All other parts in the VCS and VSS remain the
same as those listed in the VARIANT II Service Manual.

Bio Rad Description Picture Comments

Spare Parts
Part
Number
2200247 D-10/VIIT, 2 grooves to
Piercing facilitate
Needle Piercing Needle venting
2702361 VSST
Column
Heater
Block

2702362 VSST
Cartridge
Holder
Turbo 2.0
requires
additional
parts

2702363 VSST Pre- Bobbin with


Heat tubing; install
Tubing Coil in column
heater block

L70243200 Service Manual 9-1


VARIANT ™ II TURBO Hemoglobin Testing System

Bio Rad Description Picture Comments


Part
Number
2702367 VSST
Needle
Cover,
Green/Turbo
re Parts
Spare

2702360 VSS
Conical
Dilution
Chamber

2702354 VSST Tube Tube Holder


Holder Drvr Driver PCB
PCB 293 #293

2702355 VSST XYZ


Connect
PCB 294-
254-1

2702356 VSST Z
Sensor PCB
294-255-7

2702357 VSST Z-
Axis PCB
294-254-4

9-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Bio Rad Description Picture Comments


Part
Number
2702358 VSST Z-Axis
Cable 1 (20
Pin)

Spare Parts
2702359 VSST Z-Axis VSST Z-Axis
Cable (5 Pin) Cable 2, 5 Pin

2702364 VSST Mixing Mixing Coil Kit


Coil Tubing

2702141 VCS S.STEEL SS Tubing 1.58


TUBE: x 0.25 x 140mm
1.58X0.25X1M (Spare Part, Not
Required)

L70243200 Service Manual 9-3


VARIANT ™ II TURBO Hemoglobin Testing System

9.2 Reliability Parts

The following reliability parts are required before upgrading a VARIANT II to a


VARIANTII TURBO.

Bio Rad Description Picture Comments


Part
Number
2702347 VSS Tube NOTE:
(see note) Holder upg All Variant II
Spare Parts

Ver. 4 systems S/N


11452 and
higher have
been upgraded
to VSS Tube
Holder Update
(Ver. 4)

2702169V VII Rebuild Inj Valve


Kit for Rebuild Kit
RV700-123 Vespel

NOTE: The
Vespel rotor
seal (7750-16)
will have VS
stamped into
the surface.
The PEEK
rotor seal will
have PK
stamped into
the surface.

2702073 VSS Pinch Pinch Valve


Valve D – (V3 & V4).
V3, V4, V7 Update to
larger pinch
valve.
Same part as
V7.

NOTE: Order
2 valves for
each Variant
VSS Pinch Valve D - V3, V4, V7 II upgrade.

9-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Bio Rad Description Picture Comments


Part
Number
2702341 VSS Valve
Bracket Kit
PV 3/4

Spare Parts
2702353 VSS
Internal
Waste Tank
Baffle

2702340 VSS Waste


Tube Assy
PV 3/4

L70243200 Service Manual 9-5


Spare Parts VARIANT ™ II TURBO Hemoglobin Testing System

9-6 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Appendix A

Appendix A
Fluidic Diagrams

Table of Contents:

VCS Tubing Diagram A-3

VSS Tubing Diagram A-5

L70243200 Service Manual A-1


Appendix A VARIANT ™ II TURBO Hemoglobin Testing System

A-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Bio-Rad P/N *
270-2136 Cartridge Holder
270-2136
270-2137
270-2180
270-2138
270-2138
270-2138
270-2138
270-2138
270-2138
270-2138
270-2138
270-2096
270-2096
270-2139
270-2139
270-2143
270-2142
270-2143
270-2139
270-2139
270-2139
**
270-2140
270-2140
270-2140
270-2141
270-2141
270-2141
270-2141

270-2363

** SL 1-4 270-2084
SL 5-8 270-2083
Pre-cut with fittings

* MUST BE CUT TO LENGTH


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VARIANT ™ II TURBO Hemoglobin Testing System

A-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Tubing List
Bio-Rad P/N* Part No: ID x OD x L Material (Remark)
270-2021** L1: 1 x 2 x 550 Teflon Tube
270-2023** L2: 1 x 3 x 60 Si-Tube (CKD/HYN-3-1)
270-2023** L3: 1 x 3 x 145 Si-Tube (CKD/HYN-3-1)
270-2023** L4: 1 x 3 x 45 Si-Tube (CKD/HYN-3-1)
270-2023** L5: 1 x 3 x 100 Si-Tube (CKD/HYN-3-1)
270-2023** L6,7: 1 x 3 x 20 Si-Tube (CKD/HYN-3-1)
270-2023** L8: 1 x 3 x 50 Si-Tube (CKD/HYN-3-1)
270-2024 L9: 2 x 4 x 400 Si-Tube
270-2022** L10: 0.5 x 1.58 x 700 Teflon Tube
270-2025 L11: 3 x 5 x 730 Si-Tube (CKD/HYN-5-3)
270-2025 L12: 3 x 5 x 730 Si-Tube (CKD/HYN-5-3)
270-2025 L13: 3 x 5 x 760 Si-Tube (CKD/HYN-5-3)
270-2025 L20: 3 x 5 x 40 Si-Tube
270-2025 L21: 3 x 5 x 450 Si-Tube (CKD/HYN-5-3)
270-2026 L22,23: 4 x 7 x 450 Si-Tube
270-2025 L24 -27: 3 x 5 x 30 Si-Tube
270-2023 L28,29: 1 x 3 x 70 Si-Tube (CKD/HYN-3-
1)
270-2023 L30: 1 x 3 x 110 Si-Tube (CKD/HYN-3-1)
270-2023 L31: 1 x 3 x 70 Si-Tube (CKD/HYN-3-1)
270-2025 L32 -34: 3 x 5 x 30 Si-Tube
270-2026 L35: 4 x 7 x 190 Si-Tube
270-2025 L36: 3 x 5 x 250 Si-Tube (CKD/HYN-5-3)
270-2026 L37: 4 x 7 x 80 Si-Tube
270-2026 L38,39: 4 x 7 x 360 Si-Tube
270-2026 L40: 4 x 7 x 130 Si-Tube
270-2075 L41: 5 x 8 x 30 Si-Tube
270-2027 L42: 5 x 8 x 2.5m Si-Tube

Note: L14, L15, L16, L17, L18 and L19 are NOT

P/N 270-2133
fittings
P/N 270-2204

270-2028
Tube Fitting Set

*MUST BE CUT TO LENGTH


** P/N 270-2340 includes fittings

PV 1,2, 5, 6 HYN-3 CKD


PV3,4, 7 HYN-5 CKD

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VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

Appendix B

Appendix B
Mechanical Drawings

Table of Contents:

VCS

V2T Column Cartridge Holder B-3

V2T Column Holder Block and Tubing Coil Assembly B-5

VSS

Sampling Head Unit B-7

L70243200 Service Manual B-1


VARIANT ™ II TURBO Hemoglobin Testing System
Appendix B

B-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Guard Cartridge

Appendix B

L70243200 Service Manual B-3


VARIANT ™ II TURBO Hemoglobin Testing System
Appendix B

B-4 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

L70243200 Service Manual B-5


VARIANT ™ II TURBO Hemoglobin Testing System

B-6 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

L70243200 Service Manual B-7


VARIANT ™ II TURBO Hemoglobin Testing System

B-8 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

Appendix C

Electronic Diagrams and Layer Drawings

Appendix C
Table of Contents:

VCS

VCST Electric Block C-3

VSS

VSST Electric Block C-5


VSST Tube Holder Driver PCB 293 C-7
VSST Tube Holder Driver PCB 293 (Layer Drawing) C-9
VSST Connection PCB 294-254-1, 294-254-4 and 294-255-7 C-11
VSST XYZ Connect PCB 294-254-1 (Layer Drawing) C-13
VSST Z Axis PCB 294-254-4 (Layer Drawing) C-15
VSST Z Sensor PCB 294-255-7 (Layer Drawing) C-17
VSST Tube Holder Sensor PCB 295-253-7 and 295-253-8 C-19
VSST Tube Holder Sensor PCB 295-253-7-8 (Layer Drawing) C-21

L70243200 Service Manual C-1


VARIANT ™ II TURBO Hemoglobin Testing System
Appendix C

C-2 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

P/N 270-2199
P/N 270-2089
P/N 270-2191
P/N 270-2011 P/N 270-2012
P/N 270-2126
(Includes Sensor) (Includes Sensor)

P/N 270-2168
P/N 270-2127
P/N 270-2125
P/N 270-2188
P/N 270-2123

P/N 270-2122

P/N 270-2093
P/N 270-2082

P/N 270-2121 P/N 270-2085

P/N 270-0127
P/N 270-2120
P/N 270-2092

P/N 270-2082
P/N 270-2085

P/N 270-0153
P/N 270-2188

P/N 270-2098 P/N 270-2144

P/N 270-2146
P/N 270-2187 P/N 270-0206 P/N * See Below

* Replace Entire I/O Port


Assembly P/N 270-2128 for
P/N 270-2193 Board 247-2
P/N 270-2095
P/N 270-0202
P/N 270-2097 P/N 270-2132

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VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

P/N 270-2207
P/N 270-2200
P/N 270-2060 P/N 270-2073
(V3 or V4)
P/N 270-2068
P/N 270-2010
P/N 270-2074
P/N 270-2235

P/N 270-2048
P/N 270-2198

P/N 270-2062
P/N 270-2050 P/N 270-2066
P/N 270-2067
(PCB 256)
P/N 270-2071

P/N 270-2049 P/N 270-2072

P/N 270-2073

P/N 270-2250

P/N 270-2037 (either)


P/N 270-2059
P/N 270-2357

P/N 270-2202

P/N 270-2223

P/N 270-2037
P/N 270-2037
P/N 270-2356 P/N 270-2065
(applies to 255-1 P/N 270-2206
P/N 270-2203
P/N 270-2355

through 255-6)

P/N 270-2201 P/N 270-2063


P/N 270-2354

P/N 270-2038
P/N 270-2247 (either)

P/N 270-2041

P/N 270-2194
P/N 270-2065
(applies to 255-1 P/N 270-2069 (for any) P/N 270-2234 P/N 270-2205
through 255-6)

P/N 270-2057 P/N 270-2247

P/N 270-2347 (includes home and hold sensors, wiring)

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VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

C - 10 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

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C - 12 Service Manual L70243200


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VARIANT ™ II TURBO Hemoglobin Testing System

C - 14 Service Manual L70243200


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C - 18 Service Manual L70243200


VARIANT ™ II TURBO Hemoglobin Testing System

L70243200 Service Manual C - 19


VARIANT ™ II TURBO Hemoglobin Testing System

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VARIANT ™ II TURBO Hemoglobin Testing System

C - 22 Service Manual L70243200

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