BioCare Medical VALENT User manual

www.biocare.net
VALENT®Manual
Automated Slide Staining Platform User Manual
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Biocare Medical
Technical Support:
800-799-9499 Option 3
Customer Service:
800-799-9499 Option 2
Fax:
925-603-8080
Corporate Office:
60 Berry Drive
Pacheco, CA 94553
www.biocare.net

Chapter 1: Introduction ����������������������������������������������������������������������������������������������������������������������������������������������������������� 1
Intended Use......................................................................................................................................................... 1
About the VALENT Automated Staining Platform ....................................................................................................... 1
Limitation of Use ................................................................................................................................................... 1
VALENT Specifications................................................................................................................................................... 1
VALENT Cart Specifications ................................................................................................................................... 2
Reagent Vial Label and Slide Label Printers.............................................................................................................. 2
Report Printer ........................................................................................................................................................ 2
USB Flash Drive..................................................................................................................................................... 2
Warranty................................................................................................................................................................ 2
VALENT Components ..................................................................................................................................................... 3
Z-Head Schematic.................................................................................................................................................. 4
VALENT Cart Components ....................................................................................................................................... 4
Carboy Connections ................................................................................................................................................ 4
VALENT Description of Parts .......................................................................................................................................... 6
Storage and Handling .................................................................................................................................................... 8
Reagents ............................................................................................................................................................... 8
Humidity ............................................................................................................................................................... 9
Waste Disposal ...................................................................................................................................................... 9
Instrument Disposal ............................................................................................................................................... 9
Site Installation Requirements................................................................................................................................. 9
Support................................................................................................................................................................. 9
Chapter 2: Safety Precautions������������������������������������������������������������������������������������������������������������������������������������������������ 10
Recommended Use .............................................................................................................................................. 10
Reagents and Chemicals ....................................................................................................................................... 10
Reagent Rack ...................................................................................................................................................... 10
Instrument Safety Guidelines ................................................................................................................................ 10
Programming Cautions.......................................................................................................................................... 10
Lithium Battery.................................................................................................................................................... 11
Safely Turning on the Cart..................................................................................................................................... 11
Turn ON the Cart.................................................................................................................................................. 11
Turn OFF the instrument ....................................................................................................................................... 12
Symbols Glossary ................................................................................................................................................. 13
Chapter 3: VALENT Software Features & Functions ����������������������������������������������������������������������������������������������������������������� 14
User Access......................................................................................................................................................... 14
Login .................................................................................................................................................................. 14
Home Screen....................................................................................................................................................... 14
Home Screen Features.......................................................................................................................................... 15
Run Designation Buttons ..................................................................................................................................... 16
Menu Bar ............................................................................................................................................................ 16
Staining Run ....................................................................................................................................................... 16
Data Manager ...................................................................................................................................................... 17
Tools................................................................................................................................................................... 18
Print Reports ....................................................................................................................................................... 19
Configure Reagent Wash Lists................................................................................................................................ 20
Table of Contents

Contamination List ............................................................................................................................................... 20
PrepWash List...................................................................................................................................................... 20
Aqua Rinse Wash List ........................................................................................................................................... 20
View Menu........................................................................................................................................................... 21
Notifications........................................................................................................................................................ 21
Run Time Estimates ............................................................................................................................................. 21
Cleaning Log........................................................................................................................................................ 22
Run Log .............................................................................................................................................................. 22
Help .................................................................................................................................................................. 22
Chapter 4: Program Preparation & Setup �������������������������������������������������������������������������������������������������������������������������������� 23
Administrator Program Preparation & Setup ........................................................................................................... 23
Summary of Administrator vs. Regular User Profile.................................................................................................. 23
Assign or Modify Users ......................................................................................................................................... 23
User Information Guideline .................................................................................................................................. 24
Modify a User Account.......................................................................................................................................... 24
Software Settings ................................................................................................................................................. 25
System Parameters............................................................................................................................................... 26
Instrument Parameters ......................................................................................................................................... 26
Reagent Manager......................................................................................................................................................... 27
Reagent Groups ................................................................................................................................................... 27
DePar.................................................................................................................................................................. 27
Antigen Retreval .................................................................................................................................................. 27
Enzyme .............................................................................................................................................................. 27
Block .................................................................................................................................................................. 27
Antibody.............................................................................................................................................................. 27
At the bottom of the Reagent Details box:............................................................................................................... 28
Negative Serum Group.......................................................................................................................................... 28
Secondary Group.................................................................................................................................................. 28
Tertiary Group ...................................................................................................................................................... 28
Chromogen Group................................................................................................................................................. 28
Counter Stain Group ............................................................................................................................................. 28
Ancillary Group .................................................................................................................................................... 28
Mix Group ........................................................................................................................................................... 28
Display Reagent Information.................................................................................................................................. 28
Template Manager ....................................................................................................................................................... 30
Description of Template Manager Icons .................................................................................................................. 30
Creating a Template from a Blank Template ............................................................................................................ 30
Create a Template from an Existing Template .......................................................................................................... 32
Delete and Modify Templates ................................................................................................................................ 32
Additional Program Preparation & Setup ........................................................................................................................ 33
Custom Groups .................................................................................................................................................... 33
How to Create a Custom Group .............................................................................................................................. 33
Delete a Custom Group ........................................................................................................................................ 34
Edit a Custom Group ............................................................................................................................................ 34
Slide Fields ......................................................................................................................................................... 35
Slide Map Fields .................................................................................................................................................. 36
Slide Label Designer............................................................................................................................................. 37

Reagent Label Designer ....................................................................................................................................... 38
Report Field ........................................................................................................................................................ 39
Chapter 5: Before Starting a Run ������������������������������������������������������������������������������������������������������������������������������������������� 40
Tissue Preparation................................................................................................................................................ 40
Positive and Negative Controls............................................................................................................................... 40
Bulk Reagent Preparation...................................................................................................................................... 40
Slide Preparation ........................................................................................................................................................ 41
Slide Specifications.............................................................................................................................................. 41
Slide Labels......................................................................................................................................................... 41
Tissue Placement on Slide .................................................................................................................................... 41
Slide Trays .......................................................................................................................................................... 42
Inserting Slides into the Slide Tray......................................................................................................................... 42
Removing Slides from the Slide Tray ...................................................................................................................... 42
Instrument Preparation ................................................................................................................................................ 43
Drain Waste & Prime Buffers ........................................................................................................................................ 44
Prime Probe......................................................................................................................................................... 44
Prime Buffers ...................................................................................................................................................... 44
Prime DePar ........................................................................................................................................................ 45
Prime Troughs and Manifold.................................................................................................................................. 45
Drain Waste ......................................................................................................................................................... 46
Reagent Manager......................................................................................................................................................... 47
Add, Delete, and Modify Reagents ......................................................................................................................... 47
Add a New Reagent ............................................................................................................................................. 47
Delete a Reagent ................................................................................................................................................. 48
Modify a Reagent ................................................................................................................................................ 48
Import a Reagent from Reagent Manager................................................................................................................ 49
Add a Reagent in Mix Group ................................................................................................................................. 51
Specify Mixing Properties ..................................................................................................................................... 52
Volume Calculation for Mixing Reagents ................................................................................................................. 53
Inventory Manager ....................................................................................................................................................... 55
View Reagents ..................................................................................................................................................... 55
Add Reagents ..................................................................................................................................................... 56
Delete Reagents and Clean Inventory ..................................................................................................................... 57
Print Labels in Inventory Manager ................................................................................................................. 57
Register Reagents in Inventory Manager ................................................................................................................ 58
Protocol Manager ................................................................................................................................................ 59
Protocol Manager Features .................................................................................................................................... 60
Create a Protocol.................................................................................................................................................. 61
Create a New Protocol........................................................................................................................................... 61
Create a Protocol from a Template.......................................................................................................................... 62
Create a Protocol from a Selected Protocol.............................................................................................................. 63
Chapter 6: Prepare and Start a Run���������������������������������������������������������������������������������������������������������������������������������������� 64
Process Overview 1............................................................................................................................................... 64
Process Overview 2............................................................................................................................................... 64
1. Login ..................................................................................................................................................................... 65
Home Screen....................................................................................................................................................... 65
2. Prepare Slides......................................................................................................................................................... 66

Prepare and Edit Slides ....................................................................................................................................... 66
Add, Delete and Copy Slides from Slide Manager .................................................................................................... 67
Import Slides from Slide Manager.......................................................................................................................... 69
Save Slides for a Later Run .................................................................................................................................. 70
3. Print Labels ............................................................................................................................................................ 71
View and Print Reagent Worksheet ......................................................................................................................... 72
4. Scan Slides............................................................................................................................................................. 73
5. Prepare and Load Reagents ...................................................................................................................................... 75
6. Scan or Map Reagents ............................................................................................................................................. 76
7. Pre-Start Checklist................................................................................................................................................... 77
8. Start Staining ......................................................................................................................................................... 79
Slide and Reagent Information .............................................................................................................................. 79
Reagent Information............................................................................................................................................. 80
Run Complete...................................................................................................................................................... 80
Clear the Completed Trays..................................................................................................................................... 81
Map Slides.................................................................................................................................................................. 82
1. Login ............................................................................................................................................................. 82
2. Map Slides ..................................................................................................................................................... 83
3. Manually Assign Slides ..................................................................................................................................... 84
4. Load Labeled Slides ......................................................................................................................................... 85
5. Prepare and Load Reagents............................................................................................................................... 85
6. Scan or Map Reagents ...................................................................................................................................... 86
7. Pre-Start Checklist ........................................................................................................................................... 88
8. Start Staining .................................................................................................................................................. 89
Chapter 7: System Cleaning��������������������������������������������������������������������������������������������������������������������������������������������������� 90
Daily ................................................................................................................................................................... 90
Weekly ................................................................................................................................................................ 90
Program Cleaning ................................................................................................................................................ 91
Monthly............................................................................................................................................................... 93
Clean AR Carboys................................................................................................................................................. 95
Drain the Secondary Containment Sump................................................................................................................. 95
Additional Cleaning of the Instrument .................................................................................................................... 95
Chapter 8: Troubleshooting ���������������������������������������������������������������������������������������������������������������������������������������������������� 96
Printer Port Connections ....................................................................................................................................... 96
Changing Printer Labels and Ribbons..................................................................................................................... 96
Staining Performance ........................................................................................................................................... 97
Mechanical.......................................................................................................................................................... 97
Electrical............................................................................................................................................................. 99
Operating Errors................................................................................................................................................... 99
Appendix- Quick Start Guides.............................................................................................................................. 102
Quick Start Guide 1-Instrument Preparation ......................................................................................................... 102
Instrument Preparation ....................................................................................................................................... 102
Quick Start Guide 2-Creating a Protocol ............................................................................................................... 103
Quick Start Guide 3-Preparing Slides ................................................................................................................... 104
Quick Start Guide 4-Process Overview .................................................................................................................. 105
Process Overview 1............................................................................................................................................. 105
Process Overview 2............................................................................................................................................. 105
Appendix- Electrical Labels ������������������������������������������������������������������������������������������������������������������������������������������������� 106

Definitions, Acronyms and Abbreviations:
Name Description
AR Antigen Retrieval
DAB 3, 3’ Diaminobenzidine
DePar Deparaffinization (also called Dewaxing).
DI Water Deionized Water
FFPE Formalin Fixed Paraffin Embedded
HIER Heat Induced Epitope Retrieval
HRP Horseradish Peroxidase
IHC Immunohistochemistry
IF Immunofluorescence
L Liters
LED Light Emitting Diode
mL Milliliter
mm Millimeter
Probe dispense range The minimum and maximum reagent volume that can be dispensed by an instrument.
PPE Personal Protective Equipment
Pollution degree Pollution degree measures how much conductivity is in the air including dry pollution and condensation
which determines how close to each other conductive parts can be in the instrument.
RT Room Temperature (20°C-25°C)
µL Microliters
UE Unhandled Exception

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Chapter 1: Introduction
Intended Use
This manual is intended for use by clinical, research, industry and reference laboratory personnel who use the VALENT Automated Staining
Platform to perform immunohistochemistry (IHC) staining. This manual describes how to operate the VALENT using the VALENT Software
and will assume users have been trained and have a basic understanding of IHC procedures.
About the VALENT Automated Staining Platform
The VALENT is Biocare Medical’s highest-capacity, fully-automated, open-architecture slide stainer designed to perform high-quality
and consistent IHC staining in lieu of manual staining methods without the variability. However, the VALENT retains the ability to
integrate established manual staining protocols with an automated platform for ease of use with minimal optimization. The VALENT
incorporates on-board deparaffinization and heat-induced antigen retrieval, while expanding capacity to 48 slides and shortening turn-
around-time compared with other auto-stainers.
Limitation of Use
The optimum antibody dilution and protocol for a specific application can vary due to different factors. These may include, but are
not limited to: tissue fixation, antigen retrieval method, incubation times, tissue section thickness and detection kit used. Due to the
superior sensitivity of Biocare Medical’s reagents, the recommended incubation times and titers listed in product data sheets are not
applicable to other detection systems as results may vary and will have to be optimized by the user. The datasheet recommendations
and protocols are based on exclusive use of Biocare Medical products. Ultimately, it is the responsibility of the investigator to determine
optimal staining protocol conditions. The clinical interpretation of any positive or negative staining should be evaluated within the
context of clinical presentation, morphology and other histopathological criteria by a qualified pathologist. The clinical interpretation
of any positive or negative staining should be complemented by morphological studies using proper positive and negative internal and
external controls as well as other diagnostic tests.
VALENT Specifications
Slide capacity 48
Independent slide trays 4 trays, 12 slides per tray
Refrigerated reagent & mixing vial rack 44 positions, 20mL vials;
Temperature range: room temperature to 10°C below room temperature
Antigen retrieval temperature range Room temperature to 98°C at sea level
Reagent dispensing volume 300µL
Probe dispense capacity 300µL -14.4mL (48 slides x 300µL/slide)
DePar dispense volume per slide 1mL
Bulk reagent carboys 4
Waste carboys 2
Waste separation Separates hazardous and non-hazardous
Unit control One instrument per computer
Electrical requirements
Power input: 1800W (1800VA) / Power source: 100-120 VAC, 50/60Hz
The VALENT cannot be used without the VALENT Cart. Power supplied to the VALENT
from the VALENT Cart may reach 3600W@ 120V.
The use of a dedicated circuit capable of delivering a minimum of 1850W continuously
with less than 5% voltage sag is required for the instrument�
Instrument dimensions 40”W X 24”D X 26”H / 102cm W X 61cm D X 66cm H
Instrument weight 245lbs / 111.1 kg

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VALENT Cart Specifications
Bulk reagent carboys Six carboys, 8L capacity per carboy.
Secondary containment capacity 11L maximum capacity
Electrical requirements
Power output: 3600W(3600VA)
Power source: 100-120 VAC 50/60 Hz
Requires a step-down transformer rated for 2kW for operation using 220V mains (not
supplied)� Cart must be factory-configured for 50Hz operation�
Do not plug anything into the VALENT Cart besides the computer and label printers�
VALENT Cart dimensions 40”W X 24”D X 30”H / 102cm W X 61cm D X 77cm H
Cart weight 250lbs / 113.4 kg
Undervoltage and
overvoltage protection
The VALENT Cart is protected from undervoltage/overvoltage conditions by internal relays
built into the inverter/charger which will limit input voltage to 85-140VAC. Operation is
prevented if input voltage is outside the specified range.
NOTE: All cart circuit breakers must be in the OFF (down) position before disconnecting
the power cord from the cart or the wall outlet� Failure to do so may cause the batteries
to run down and necessitate a service call�
Reagent Vial Label and Slide Label Printers
The VALENT Software is compatible with Microsoft Windows 10 and will have all computer system software pre-installed. The system
also includes two TSC TC310 Thermal Transfer Printers. One printer is required for slide labels and the second printer is required for
reagent vial labels.
Report Printer
Please see manufacturer’s specifications.
USB Flash Drive
The VALENT Software allows for the transfer of data to a USB external drive.
Warranty
The VALENT warranty is for one year from date of installation and covers all parts and labor when service is performed solely by Biocare
Medical Field Services Personnel. The warranty is invalidated if equipment is abused, damaged, misused, or improperly maintained by
the customer, as determined by Biocare Medical at its sole discretion. The warranty is not transferable to any other party, should the
equipment be resold or transferred by the customer to another party. To the extent permitted by law, Biocare Medical disclaims any
liability for any incidental or consequential damages related to this equipment or for any warranty related services it performs.

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VALENT Components
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1. System Lid
2. Window
3. Slide Trays
4. Reagent Rack
5. System Board Cover
6. Power Switch
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1. Z-head
2. Probe Wash Station
3. Dispense Manifold
4. Reagent Rack
5. Val DePar (Side)
6. Syringe Pump
7. System Lid
8. Fans (8 Total)
9. Troughs (Below Slide Tray)
10. Slide Trays (4 Total)
11. Service Panel

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Z-Head Schematic
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A probe schematic which includes a separate probe for Val DePar, reagent and Wash-Blow-Wash.
1. Liquid Level Sensor
2. Barcode Camera
3. Wash-Blow-Wash
4. Val DePar Probe
5. Reagent Probe
VALENT Cart Components
Carboy Connections
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Image of carboy connection panel.

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Carboy Connections
AR HI pH (White)
AR LO pH (Red)
AQUA RINSE (Yellow)
WASH BUFFER (Blue)
HAZARDOUS WASTE (Black)
WASTE (Teal)
Image of a carboy and carboy sensor cables
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Side view of the VALENT Cart displaying electrical connections.
1. Carboys
2. Secondary Containment
3. Instrument Power Circuit Breaker
4. Cart Power Circuit Breaker
5. Battery Circuit Breaker
6. Air Vents
NOTE: All cart circuit breakers must be in the OFF (down) position before disconnecting the power cord from the cart or the wall outlet�
Failure to do so may cause the batteries to run down and necessitate a service call�

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VALENT Description of Parts
Parts Description
Independent slide trays
The VALENT includes four removable stainless steel slide trays, each with a 12-slide
capacity. The slide trays secure the slides firmly in a horizontal position at all times
during the staining run. The slide trays can be removed from the instrument for loading
slides, and then reinserted, without opening the system lid.
There is an LED sensor which, when RED, indicates the slide tray is locked in place
and may not be removed. When the LED turns green, the slide tray may be removed or
reinserted. The LED is off when a slide tray is removed from the instrument.
System lid
The VALENT system lid operates with a gas strut motion control system which allows
access to the work surface. The system lid automatically locks at the start of a run. The
lid must be closed during the operation of the instrument. The system lid status can be
viewed from the VALENT Software Home Screen or by the LED light (red if locked, green
if unlocked).
Syringe pump The syringe pump is a positive displacement pump used for aspiration and dispensing of
reagents on slides, for mixing reagent components and probe washing.
Fans
The internal fans are designed to reduce humidity and temperature during heated
antigen retrieval. There are a total of 8 fans in the upper chassis, 4 intake fans are
located on the VALENT system lid and 4 exhaust fans are located on the back panel
of the VALENT. The fans operate in different combinations and automatically turn
on and off during AR. In addition, there are five fans in the lower chassis to cool the
componentry following AR.
Reagent rack
The reagent rack is a stainless steel rack with 44 vial positions for 20mL VALENT vials,
this rack can slide in and out of the instrument without opening the system lid. The
reagent rack is cooled throughout the run keeping reagents below room temperature.
Each reagent rack is calibrated to a specific instrument and can’t be substituted for
another reagent rack.
Reagent vials
All vials have a 20mL capacity with a screw cap and a 50µL dead volume. Vials can
be filled with the volume specified by the selected protocol or with excess volume in
preparation for use in a subsequent run.
The VALENT will mix designated reagents in empty 20mL VALENT vials when online
mixing is selected. Do not re-use mixing vials; always use new, clean mixing vials to
prevent contamination and/or staining artifacts. The VALENT Software automatically
calculates a 50µL dead volume for all mixing vial reagents.

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Z-head
The Z-head, (see Figure 1c), is mounted on the Y-arm that moves along the horizontal
left/right X-axis inside the instrument. The following are components of the Z-head:
Reagent Probe: The instrument uses a Teflon coated stainless steel probe. The probe is
washed inside and out before each new reagent is applied. The reagent probe employs a
high-accuracy dispense mechanism which gently dispenses reagents across a slide in a
manner that avoids any tissue disruption.
Liquid Level Sensor: The ultrasonic level sensor detects the reagent volume level. The
system will provide a visual alarm if there is insufficient reagent to complete the run.
The run will not start if reagent volumes are insufficient for the programmed protocols.
Barcode camera: The barcode camera, is used for scanning slide and reagent barcodes
and is capable of Optical Character Recognition (OCR) and image recognition. The
barcode camera ensures that the correct vials and slides are in place to prevent errors.
Additionally, the barcode camera allows the software to alert the user if reagent vial
caps are still mistakenly left in place before a run starts.
Wash-Blow-Wash Nozzle: In a single pass, the nozzle applies a layer of Aqua Rinse or
Wash Buffer, followed immediately by a curtain of air to blow off the wash, and then a
second layer of Aqua Rinse or Wash Buffer to wash a second time. This occurs at each
rinse step and also at preset intervals to keep slides from drying out during the holding
time before the start of a run. The air nozzle removes excess liquid from a slide before
applying reagents by blowing air across the entire width of the slide.
Probe wash station The probe wash station is located next to the Z-head park position and is used to wash
the reagent probe. The reagent probe is cleaned in the wash station throughout a run.
Bulk reagents and carboys: Antigen
Retrieval (AR), Aqua Rinse and Wash
Buffer
AR-Hi pH, AR-Lo pH, Wash Buffer and Aqua Rinse Carboy assemblies have liquid level
sensors to detect volume levels. The carboys allow for a nominal volume of 8L with
1L of dead volume. If there is insufficient Wash Buffer or Aqua Rinse in the carboy
assemblies, the instrument will not initiate the staining process.
Check the levels of the bulk reagents before each run, replenish and reset if indicated
by the VALENT Software during the staining process. The required volumes for each run
are calculated by the VALENT Software and displayed during the programming process.
Bulk mixing carboys
10L bulk mixing carboys are used for preparing bulk reagents which include Wash
Buffer, Aqua Rinse and Antigen Retrieval. Bulk reagents prepared in these bulk mixing
carboys will be transferred to the 8L bulk reagent carboys on the VALENT Cart.
Waste storage
The VALENT separates hazardous and non-hazardous waste. A non-hazardous waste 8L
carboy and a hazardous waste 8L carboy are provided for accumulated waste collection.
The actual amount of waste volume generated will depend on the number of slides
programmed per run and staining protocol. The required available volumes for each run
are calculated by the VALENT Software and displayed during the programming process.
Both waste carboy volumes should be checked and emptied as needed before starting a
staining run.
Dispense Manifold There is a dispense manifold for each trough that dispenses AR and Aqua Rinse onto the slide.
Troughs There are four troughs on the VALENT, located below the slide trays, that are used for
the antigen retrieval step and draining reagents to waste.
DePar A mineral oil based deparaffinization reagent is held in a 500mL bottle located to on the
left side of the VALENT.
Window The VALENT has a red window to prevent photobleaching of fluorochromes.

8
Storage and Handling
Reagents
Always follow manufacturers’ instructions for storage and handling of reagents. To prevent contamination, follow good laboratory
practices of sterile technique when opening, diluting, and decanting all solutions. When not in use, store Biocare Medical reagents at
the recommended storage conditions as specified in the data sheets to maintain reagent stability.
Instrument Environmental Conditions
Placement Indoors, away from direct sunlight and extreme heat or cold.
Operating temperature range 15-30°C (59-86°F); Recommended: 20-24°C (68-75°F) for optimal staining results.
Storage temperature range 10-40°C (50-104°F)
Transport temperature range 0-50°C (32-122°F)
Maximum relative humidity 80%, non-condensing
Humidity Maximum relative humidity 80%, non-condensing
Ventilation
Do not block the vent openings on the VALENT.
Leave a minimum of 2 inches of space between the instrument and the wall, cabinets or
other obstructions.
Venting (exhaust) The instrument does not need special exhaust ventilation, unless required by safety
regulations when using reagents not specified by Biocare Medical.
Recommended maximum altitude
6562 feet
Lower boiling temperature and a higher evaporation rate must be considered for labs in
a higher elevation. For example, if the optimal temperature for antigen retrieval is 98°C
with an elevation below 1500 feet, the antigen retrieval temperature may have to be
optimized if the elevation is above 3750 feet.
Pollution degree 2 Normally only nonconductive pollution occurs. Temporary conductivity caused by
condensation is to be expected.
Positioning the VALENT
The right side of the instrument and VALENT Cart must be positioned at a minimum of 8
inches from any wall or other obstruction to allow access to all power switches and cables.
There must also be adequate clearance to allow disconnecting of the cart power cable
from the main wall receptacle.
Main supply voltage fluctuations ±5%
Overvoltage category Category II
Specification of heat transfer media
suitable for use
All heat transfer media are water-based reagents with high or low pH buffer salts and a
mineral oil based DePar reagent. No other media is allowed during heat cycle.

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Humidity
During Antigen Retrieval humidity levels may increase and create condensation, to prevent this the lab should have an operational HVAC system.
Avoid humidity extremes. Low humidity can cause electrostatic problems that may affect the computer. High humidity may create
condensation.
Waste Disposal
Some of the reagents used on the VALENT may be hazardous, and must be disposed of properly in accordance with local regulations.
The lab should determine from the Safety Data Sheets (SDS) for a given reagent whether the reagent is hazardous. The VALENT can be
programmed to separate waste streams for chromogens considered to be hazardous. The carboy used for this waste stream is marked
“Hazardous Waste.” This carboy must only be used solely for hazardous waste in order to avoid unnecessarily increasing the volume of
any hazardous waste.
In the event a spill of hazardous materials occurs inside the instrument, unplug instrument from the cart and unplug the VALENT Cart
from the wall outlet. NOTE: All cart circuit breakers must be in the OFF (down) position before disconnecting the power cord from
the cart or the wall outlet� Failure to do so may cause the batteries to run down and necessitate a service call� The user is required to
use PPE which may include a lab coat, gloves, and safety glasses. Use disposable absorbent material to soak up small spills. Follow
approved lab procedures for handling larger spills. Refer to appropriate Safety Data Sheets for proper handling of reagents. The VALENT
Cart has built-in secondary containment for bulk reagent spills with a 11L maximum capacity. If spills occur inside the instrument
contact Biocare Medical’s Technical Support before reconnecting the power.
It is the user's responsibility not to use decontamination or cleaning agents, other than specified in this manual that could cause a
hazard as a result of a reaction with parts of the equipment or with materials used in it. Contact Biocare Medical Technical Support
before using unspecified cleaning agents.
Instrument Disposal
If the VALENT is to be removed from service and disposed of, the instrument must be disinfected using Lysol IC Quaternary Disinfectant
Cleaner through the fluid delivery and waste systems. Similarly, all exposed surfaces must be disinfected using 10% Professional Lysol IC
Quaternary Disinfectant Cleaner before it is disposed of in accordance with local, state and federal regulations.
The VALENT Cart batteries should be re-cycled or properly disposed of in accordance with local regulations.
Site Installation Requirements
Performance checks are conducted by the manufacturer prior to shipping. Biocare Medical Field Service Personnel will unpack or
supervise the unpacking, of the VALENT. Biocare Medical Field Service Personnel will verify the system performance to determine
any deficiencies in operation as a result of shipping and will rectify any problems with regard to performance or components. Biocare
Medical Field Service Personnel will also provide basic operating instructions.
Note: The VALENT weighs approximately 245lbs and must be handled from the bottom of each side of the chassis by two people or
more who are safely capable of lifting the specified weight. Do not lift the instrument from the system lid, doing so will cause damage
to the VALENT and void the warranty.
If the VALENT is placed on a laboratory bench, the bench must be solid, vibration-free with a flat area, capable of safely supporting the
weight of the instrument. Additional consideration must be made for a minimum clearance of 2 inches on all sides for ventilation and
room for an all in one computer, keyboard and mouse next to the instrument. The label and report printers for the VALENT may be located
anywhere that allows them to be connected to the instrument. Biocare Medical will provide a cart for the computer and printers. Nothing
may be placed on top of the VALENT.
The use of a dedicated circuit capable of supplying a minimum of 1850W continuously is required for proper operation. Do not connect
the cart to the same circuit as other equipment, lighting, or any other electrically operated devices.
Support
To contact Biocare Medical Technical Support by telephone, please call 1-800-799-9499, Option 3 or email Technical Support at
[email protected].

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Chapter 2: Safety Precautions
Recommended Use
The VALENT is designed for use with FFPE tissue samples. Fresh (unfixed) tissue may contain infectious organisms, infectious sample
use is limited to tissues/specimens that are specified in Biocare Medical’s product data sheets. Handle control slides and test FFPE
slides as if capable of transmitting infectious agents, and dispose with proper precautions. It is recommended that the specimens are
handled using established good laboratory working practices.
Reagents and Chemicals
Some of the reagents and chemicals recommended by Biocare Medical for use on the VALENT are classified as hazardous. These
must always be used according to the manufacturer’s instructions and good laboratory practices. Always wear PPE such as gloves,
eye protection and a protective lab coat when handling any chemical solution used on the VALENT, and when cleaning the VALENT
or emptying waste carboys. Obtain a Safety Datasheet (SDS) from the manufacturer for each reagent. Do not use any chemicals on
the VALENT other than those specified. Biocare Medical offers Val Clean, an acid alcohol-based cleaning solution for the removal of
hematoxylin residue. Danger from hazardous fumes, fire or explosion may result with the possibility of injury to the operator or damage
to the instrument.
Reagent Rack
Always use both hands when loading and unloading the reagent rack. Using both hands, one hand holding reagent rack from the front
and the other hand from the bottom, load the reagent rack with filled reagent vials in the correct orientation; the reagent rack handle
should be towards the front of instrument, facing the user. Reagent vials must have the label positioned toward the front of the VALENT,
facing the user. When unloading a reagent rack once a run is complete, the bottom of the reagent rack may be cold, use a paper towel
or other absorbent material to hold the reagent rack from the bottom. Tipping of the reagent rack may result in injury if the rack is not
securely placed in its designated position, or handled securely during transport.
Instrument Safety Guidelines
1. Use only the authorized VALENT Software program that is supplied with the instrument, or authorized software updates.
2Do not install any other software applications onto the VALENT’s dedicated computer system. This may cause an unexpected
operation of the VALENT or corrupt the operating software and will void the instrument warranty.
3. Do not switch off power to the computer until the VALENT Software is properly closed.
4. Do not turn off power to the VALENT until all motion has stopped and the robotic arm is in the home position.
5. The system lid of the VALENT must be closed before operation will begin.
6. Do not attempt to remove reagent rack or slide trays while the system lid is locked during a run.
7. Keep carboy assemblies below the level of the VALENT.
8. Proper cleaning is important for the reliable operation of the VALENT. Follow the recommended cleaning procedures in
Chapter 7.
9. The robotic arm must be stopped before the VALENT’s system lid can be opened. The status of the system lid can be viewed
from the VALENT Software Home Screen.
10. Do not place your hands, fingers or other body parts underneath the VALENT, this may cause injury.
Programming Cautions
To help prevent false positive or false negative results ensure all staining protocols are programmed correctly. If unexpected results
occur, check the programming first. The VALENT provides the option to enter patient information for each slide. Make sure to enter the
correct patient identifier information for each slide.

11
Lithium Battery
This device contains one or more Lithium Iron Magnesium Phosphate Batteries. The batteries should not be opened or burned. The
batteries are safe with normal use. Exposure to the ingredients contained within and or their combustion products could be harmful.
Risk of exposure occurs only if the battery is mechanically, thermally, or electrically abused to the point of compromising the battery
enclosure. If the battery enclosure is compromised, exposure to the electrolyte solution contained within can occur by inhalation,
ingestion, eye contact and skin contact. More information is available from the manufacture of the battery, LithiumWerks.
Safely Turning on the Cart
If the VALENT Cart must has to be switched on or off, the instrument must be switched on or off in a specific order to avoid system
failure. Instances where the instrument cart may need to be turned on or off include:
• When moving the instrument to a different location.
• If there has been a power outage and the instrument requires proper shut down.
• When the user does not plan to use the instrument for at least two weeks or longer a week or more.
• If the VALENT Software and/or printers are not functioning appropriately.
Turn ON the Cart
TO INSTRUMENT
CART BATTERY
Turn cart battery OFF
when cart power is off or
cart is unplugged.
CART POWER
COMPUTER
INSTRUMENT
POWER
Power: 1,800 VA
115 VAC 100/120 VAC
Model VLT8102: 50 Hz
Model VLT8103: 60 Hz
Circuit Breaker: ISA Resettable
WARNING
1. Turn On the Cart Power Circuit Breaker
2. Turn On the Cart Battery Circuit Breaker
3. Turn On the Instrument Power Switch Circuit Breaker
1
2
3
• Confirm that all circuit breakers on the side of the cart are in the OFF (down) position, (refer to the diagram above.)
• Confirm that the cart is plugged into a dedicated electrical outlet capable of supply at least 1850W continuously.
• Confirm that the 30A instrument power umbilical from the cart is connected to the receptacle on the right side of the instrument.
• Confirm that the battery sense cable from the cart is connected to the receptacle on the right side of the instrument.
• Turn on the cart power circuit breaker, which is the white switch located on the electrical panel on the right side of the cart.
• Wait 60 seconds for the battery charger to sense wall power.
• Turn on the cart battery circuit breaker, which is the black switch located on the right side of the panel.
• Immediately after the cart battery circuit breaker is turned on, the battery charger fan inside the cart will be audible for approximately
5 seconds, indicating the charger has turned on.
• If the charger does not turn on, toggle the cart battery circuit breaker off and then back on again until the charger turns on.
• Turn on the instrument power switch circuit breaker, which is the black switch located to left of on the left side of the panel.
• Turn on the instrument using the large white power switch on the right side of the instrument.
• Turn on the computer.

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Turn OFF the instrument
Turning off the instrument is the reverse order as turning on instrument:
• Exit out of software, then turn off the cumputer.
• Turn off the instrument using the large white power switch on the right side of the instrument.
• Turn off the instrument power circuit breaker which is the black switch located on the left side of the cart panel.
• Turn off the cart battery circuit breaker which is the black switch, located on the right side of the panel.
• Turn off the cart power circuit breaker, which is the white switch on the cart panel.
NOTE: All cart circuit breakers must be in the OFF (down) position before disconnecting the power cord from the cart or the wall outlet�
Failure to do so may cause the batteries to run down and necessitate a service call�