Awareness Technology CHROMATE User manual

© Awareness Technology, Inc. 2008 ChroMate Operator’s Manual Revised 2018 Rev. Q
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TABLE OF CONTENTS
1. Introduction ...................................................................................................... 1
1.1 Applications.............................................................................................................................. 1
1.1.1 Intended Use ..................................................................................................................... 1
1.1.2 Summary of the Instrument............................................................................................... 1
1.1.3 Principles of Operation ...................................................................................................... 3
1.2 Warning Markings Inscriptions d’avertissement ...................................................................... 4
1.2.1 Safety Symbols Le Symboles de Sûreté........................................................................... 4
1.2.2 Safety Terms Terminologie de Sûreté .............................................................................. 4
1.2.3 Disposal and Storage ........................................................................................................ 5
1.3 Safety Precautions ................................................................................................................... 6
1.4 Operating Precautions ............................................................................................................. 8
2. Technical Specifications ................................................................................. 9
3. Installation...................................................................................................... 10
3.1 Packing List............................................................................................................................ 11
3.2 Installation Preparation .......................................................................................................... 11
3.3 Parts and Controls ................................................................................................................. 13
3.4 Instrument Setup & Software Installation............................................................................... 15
3.4.1 Software Installation ........................................................................................................ 15
3.4.2 USB Port Connection ...................................................................................................... 17
3.5 Instrument Check Out ............................................................................................................ 18
4. Programming Assays .................................................................................... 19
4.1 General Selections................................................................................................................. 19
4.1.1 Selecting a Plate Format................................................................................................. 20
4.1.2 Loading a Plate ............................................................................................................... 21
4.1.3 Mix ................................................................................................................................... 21
4.2 Running an Assay.................................................................................................................. 22
4.2.1 Plate Layout Tab ............................................................................................................. 23
4.2.1.1 Reassign................................................................................................................. 25
4.2.2 Assay Calibration Tab ..................................................................................................... 25
4.2.2.1 Viewing Statistics.................................................................................................... 28
4.2.2.2 Viewing a Curve ..................................................................................................... 28
4.2.2.3 Edit a Curve............................................................................................................ 29
4.2.2.4 Deleting Standards (Calibrators) ............................................................................ 32
4.2.2.5 Adjusting Curves by Percentage Factor................................................................. 33
4.2.2.6 Adjusting curves by running less than all the Calibrator ........................................ 34
4.2.2.7 View assay parameters .......................................................................................... 35
4.2.3 Add Samples Tab............................................................................................................ 36
4.2.3.1 Sample Dilution Factor ........................................................................................... 37
4.2.4 Test Results Tab ............................................................................................................. 39
4.2.5 Report Tab ...................................................................................................................... 40
4.3 Tips for Running Assays ........................................................................................................ 42
4.3.1 Bichromatic Differential Operation .................................................................................. 42
4.3.2 Offset Absorbance........................................................................................................... 42
4.4 Assay Modes.......................................................................................................................... 43
4.4.1 Absorbance ..................................................................................................................... 44
4.4.2 Factor Mode .................................................................................................................... 44
4.4.3 Standard Mode................................................................................................................ 44
4.4.4 Cut Off Mode ................................................................................................................... 45
4.4.5 Point-to-Point Mode......................................................................................................... 47

4.4.6 Linear Regression Mode ................................................................................................. 48
4.4.7 Cubic Spline Mode .......................................................................................................... 48
4.4.8 Dose Response Mode..................................................................................................... 49
4.4.9 Polynomial Regression Mode ......................................................................................... 49
4.4.10 4-Parameter and 5-Parameter Logistic ......................................................................... 50
4.4.11 % Absorbance Mode ..................................................................................................... 51
5. ChroMate®Manager Software...................................................................... 52
5.1 Opening ChroMate®Manager................................................................................................ 52
5.1.1 Toolbar Icons................................................................................................................... 52
5.2 Management Menu ................................................................................................................ 53
5.2.1 Test Count ....................................................................................................................... 54
5.2.2 New Assay Calibration Data ........................................................................................... 54
5.3 Tests Menu ............................................................................................................................ 55
5.3.1 Read Plate Absorbance .................................................................................................. 55
5.3.1.1 Kinetic Read using Read Plate Absorbance .......................................................... 56
5.3.1.2 Excel Export using Read Plate Absorbance........................................................... 57
5.3.2 Create Assay................................................................................................................... 58
5.3.2.1 Assay Basic Parameters ........................................................................................ 58
5.3.2.2 Calibration – Standard Properties .......................................................................... 58
5.3.2.3 Calibration - Curve Valid Time ............................................................................... 59
5.3.2.4 Calibration – Blank Properties................................................................................ 59
5.3.2.5 Calibration – Samples ............................................................................................ 60
5.3.2.6 Calibration – Controls ............................................................................................. 60
5.3.2.7 Calibration – QC Criteria ........................................................................................ 61
5.3.2.8 Interpretation Settings ............................................................................................ 62
5.3.3 Edit Assay ....................................................................................................................... 63
5.4 Lot # Registration Menu......................................................................................................... 64
5.5 QC Tracking Menu................................................................................................................. 65
5.6 Sample Database .................................................................................................................. 66
5.6.1 Add Sample ID ................................................................................................................ 66
5.6.2 Modify Sample ID ............................................................................................................ 67
5.6.3 Delete Sample ID ............................................................................................................ 67
5.6.4 View Log.......................................................................................................................... 68
5.6.5 Import Patient Record ..................................................................................................... 68
5.6.6 Export Patient Record ..................................................................................................... 69
5.6.7 Search Patient Record .................................................................................................... 69
5.7 Settings .................................................................................................................................. 70
5.7.1 Comm Port, Database, Report Settings.......................................................................... 70
5.7.1.1 Startup .................................................................................................................... 70
5.7.1.1.1 International Calibration Factor (ICF) .................................................................. 71
5.7.1.2 Sample Database Settings ..................................................................................... 71
5.7.1.3 Result Acceptance.................................................................................................. 72
5.7.1.4 Report Appearance ................................................................................................ 72
5.7.1.5 Report Output ......................................................................................................... 73
5.7.2 Custom Report Settings .................................................................................................. 74
5.7.3 Select Language ............................................................................................................. 75
5.8 Maintenance........................................................................................................................... 76
5.8.1 Voltage Meter .................................................................................................................. 76
5.8.2 Firmware Update............................................................................................................. 77
5.8.3 Calibration Lock/Unlock................................................................................................... 77
5.9 Help........................................................................................................................................ 78
6. Troubleshooting............................................................................................. 79
6.1 Messages............................................................................................................................... 79

6.2 Errors and Flags .................................................................................................................... 80
6.3 COM Port Settings ................................................................................................................. 82
6.3.1 PC Communication (COM) Port Setting.......................................................................... 82
6.3.2 Communication (COM) Port Setting................................................................................ 85
7. Contact Information....................................................................................... 86
8. Appendix A – Laboratory Information System (LIS) ................................... 87
9. Appendix B - Installing New Software.......................................................... 89


ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q1
1. Introduction
1.1 Applications
1.1.1 Intended Use
ChroMate®is a compact, PC-controlled, multi-purpose photometer system designed to
read and calculate the results of assays, which are read in 96 well microtiter plates or strip
trays. General purpose software is included.
ChroMate® may be used for in-vitro diagnostics. It is a user-programmable open system
with selectable plate formatting, alphanumeric test naming, automatic interpretation
options, duplicate well options, curve plotting and editing, flags and error messages from
which the user can create a menu of pre-programmed assays for instant recall.
It is a general purpose instrument intended to be used by trained laboratory professionals
who are capable of selecting the appropriate features and options for each specific clinical
application. Contact your company’s instrument service provider to arrange for training if
the information provided in this manual is not sufficient for your applications.
WARNING! FOR IN-VITRO DIAGNOSTIC USE
AVERTISSEMENT! POUR L'USAGE DIAGNOSTIQUE IN VITRO
1.1.2 Summary of the Instrument
This instrument reads monochromatically (optional) or bichromatically (optimal) and has
two models:
Four-filter model (405, 450, 492, and 630 nm)
Six-filter VIS model (405, 450, 492, 545, 600, and 630 nm)
Substitute filters in the range of 405 nm - 750 nm are available on special order models.
The instrument accepts all standard microplates. Trays containing microstrips may also be
read whether they are 12 wells in length, 8 wells or even partial strips.
Pre-programmed Modes
The basic calculations include several single and multi-point equations. Provisions are
made in certain cases for reading specimens in duplicate and/or using the mean reading in
calculations. Each calculation mode is described in detail in Section 4.4 Assay Modes.
The following calculation modes are offered: Factor, Standard, Cut Off, Point to Point,
Linear Regression, Cubic Spline (Constrained), Dose Response, Polynomial 2nd Order, 3rd
Order, and 4th Order, 4-Parameter and 5-Parameter Logistic, and %Absorbance.

2ChroMate® Microplate Reader Operator’s Manual Rev. Q

ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q 3
Summary of the Instrument (continued)
•User-programmable Memory
The software allows the operator to create, edit and store assays. Standard curves are
also stored in this memory. Test protocols remain stored until either changed or deleted by
the user.
1.1.3 Principles of Operation
The optical system provides an economical and low maintenance design which reads 8
wells simultaneously. A 96 well plate can be read and printed in the absorbance mode in
approximately twelve seconds.
Light from a lamp installed in a sealed light-tight compartment is filtered using a rotating
filter wheel. The filtered light is then divided into 8 channels using a fiber optic bundle.
The plate carrier precisely positions each row of 8 wells into the optical path for reading.
Light passing through the 8 wells is directed to 8 photo-detectors.
The filter wheel moves to a second position to read the 8 wells at a second wavelength.
Using bichromatic differential absorbance values corrects for optical imperfections in the
plastic wells and removes the effects of meniscus and turbidity.
The photo-detectors generate electronic signals which are amplified and interpreted by the
instrument circuitry.

4ChroMate® Microplate Reader Operator’s Manual Rev. Q
1.2 Warning Markings Inscriptions d’avertissement
1.2.1 Safety Symbols Le Symboles de Sûreté
Symbols that may appear on the product:
Les symboles de sûreté peuvent apparaitre sur le produit:
WARNING
AVERTISSEMENT
Protective Ground
La Terre Electrique
CAUTION
L’ATTENTION
BIOHAZARD
BIOHAZARD
Risk of Shock
Risque de Choc
(Earth) Terminal
Prise de Terre
Refer to Manual
Se Rapportent a
Manuel
Risk of Infection
Risque d’infection
FUSE: For continued protection against risk of fire, replace fuse only with one of the specified type
and current ratings. Disconnect the instrument from the power supply before replacing the fuse.
FUSIBLE: Pour la protection continue contre le risque du feu, remplacez le fusible seulement par
une du type spécifique et des estimations courantes. Démontez l’équipement de l’alimentation
d’énergie avant de remplacer le fusible.
1.2.2 Safety Terms Terminologie de Sûreté
These terms may appear on the product : Les marques sur le produit
These terms may appear in this manual: Les marques dans l’opérateur manuel
DANGER
DANGER Le “de
marque: DANGER”
Indicates an injury immediately accessible as you read this marking
Indique le risque immédiat de dommages (assessible tandis que vous
lisez la marque)
WARNING
AVERTISSEMENT! Le
“de marque:
WARNING”
WARNING statements identify conditions or practices that could result
in injury or loss of life. WARNING indicates an injury hazard not
immediately accessible as you read this marking.
Ces rapports identifient les conditions ou les pratiques qui pourraient
avoir comme conséquence les dommages ou les pertes humaines.
CAUTION
L’ATTENTION “Le de
marque: CAUTION”
CAUTION statements identify conditions or practices that could result
in damage to this product or other property.
Ces rapports identifient les conditions ou les pratiques qui pourraient
avoir comme conséquence les dommages a ce produit ou a toute
autre propriété.
BIOHAZARD BIOHAZARDS are biological agents that can cause disease in
humans. Lab workers handling potentially infectious materials must
use universal precautions to reduce the risk of exposure to these
agents.
CAUTION! L’ATTENTION!

ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q 5
WARNING: If any materials are overturned during operation, immediately set
the power switch to OFF (0). This material should be treated as potentially
biohazardous. Appropriate cleanup and disposal of biohazardous waste should
be used.
Avertissement! Lors du fonctionnement, si on renverse des matériaux, coupez
immédiatement le courant. Placez le commutateur électrique a AU LOIN(0).
Traitez le matériel comme biohazardous, utilisant approprie nettoient et des
méthodes de disposition.
1.2.3 Disposal and Storage
Dispose of according to local regulations. Before the instrument is removed from the
laboratory for storage, disposal, transporting, or servicing, it must be decontaminated.
Decontamination should be performed by a well-trained authorized person, observing all
necessary safety precautions. Instruments to be returned must be accompanied by a
decontamination certificate completed by the responsible laboratory manager. If a
decontamination certificate is not supplied, the returning laboratory will be responsible for
charges resulting from non-acceptance of the instrument by the servicing center or from
any authority’s intervention.
BIOHAZARD!
WARNING: Treat all components during use and disposal as you would any
biohazardous material.
AVERTISSEMENT : Utiliser et disposer des matériaux de la même manière
que vous utilisé et disposer des matières infectieuses.

6ChroMate® Microplate Reader Operator’s Manual Rev. Q
1.3 Safety Precautions
To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined
below
.
Read Instructions Take time to read this manual carefully before using this instrument.
Review the following safety precautions to avoid injury and prevent
damage to this instrument or any products connected to it. To avoid
potential hazards, use this instrument only as specified. For best results,
familiarize yourself with the instrument and its capabilities before
attempting any clinical diagnostic tests. Refer any questions to your
instrument service provider.
Servicing There are no user-serviceable parts inside the instrument. Refer servicing
to qualified service personnel. Use only factory-authorized parts. Failure
to do so may void the warranty.
Wear Protective Apparel Many diagnostic assays utilize materials that are potential biohazards.
WARNING: Always wear protective apparel and eye protection while
using this instrument.
Follow Operating
Instructions
WARNING: Do not use this instrument in a manner not specified by the
manual, or the protection provided by the instrument may be impaired.
Use Proper Power Cord WARNING: Use only the power cord specified for this product and
certified for the country of use.
Observe All Terminal
Ratings
WARNING: To avoid fire or shock hazard, observe all ratings and
markings on the instrument. Consult this manual for further ratings
information before making connections to the instrument.
Install as Directed The instrument should be installed on a sturdy, level surface capable of
safely supporting the instrument’s weight 12.5 lbs (5.7 kg). The mounting
surface should be free of vibrations.
Provide Proper Ventilation Refer to the installation instructions for details on installing the product so
it has proper ventilation. The instrument should be surrounded by the
following clearances: 10cm around perimeter of unit and 10cm on top.
Do Not Operate Without
Protective Covers
WARNING: Do not operate this instrument with covers and panels
removed.
Avoid Exposed Circuitry WARNING: Do not touch exposed connections and components when
power is present.

ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q 7
Safety Precautions (Continued)
WARNING! AVERTISSEMENT!
Warning! To avoid electric shock, the grounding conductor must be connected to
earth ground. An optional method is to attach a ground strap from the external
grounding terminal on the rear panel of the instrument to a suitable ground such as a
grounded pipe or some metal surface to earth ground.
Use Proper Fuse Use only the fuse type and rating specified by the manufacturer for this
instrument
Do Not Operate In An
Explosive Atmosphere
WARNING: Do not operate instrument in an explosive atmosphere.
Do Not Operate With
Suspected Failures
WARNING: If you suspect there is damage to this instrument, have it
inspected by a qualified service person.
Do Not Operate in
Wet/Damp Conditions
WARNING: Do not operate instrument in wet/damp conditions.
Keep Instrument Surfaces
Clean and Dry
CAUTION: Solvents such as acetone or paint thinner will damage the
instrument.
•Do not use solvents to clean the unit. Avoid abrasive cleaners; the
display overlay is liquid-resistant, but easily scratched.
•Clean the exterior of the instrument with a soft cloth using plain water.
If needed, a mild all-purpose or nonabrasive cleaner may be used.
•Use as a disinfectant a 10% solution of chlorine bleach or 70%
isopropyl alcohol.
•
Take special care not to spill liquid inside the instrument

8ChroMate® Microplate Reader Operator’s Manual Rev. Q
1.4 Operating Precautions
NOTE: Insufficient RAM will adversely affect the performance of your instrument. For Microsoft®
Windows 7, the recommended minimum amount of RAM is 512 MB.
Avoid lifting, leaning or turning the instrument over when a plate is in place.
Be sure to run a sufficient number of controls in each assay. If controls are not within their
acceptable limits; or if incomplete, disregard test results.
CAUTION! L’ATTENTION!
WARNING: If any materials are overturned during operation, immediately set the
power switch to OFF (0). This material should be treated as potentially
biohazardous. Appropriate cleanup and disposal of biohazardous waste should be
used.
Avertissement! Lors du fonctionnement, si on renverse des matériaux, coupez immédiatement le
courant. Placez le commutateur électrique a AU LOIN(0). Traitez le matériel comme
biohazardous, utilisant approprie nettoient et des méthodes de disposition.

ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q 9
2. Technical Specifications
The plate moves toward the front and back of the instrument.
When taking an optical reading, the reaction plate automatically positions itself under the 8-
channel optical system. A filter wheel with four or six filters rotates below the plate.
Depending on the setup, reports may be displayed or printed to create permanent lab records
and physician reports.
•Photometer:
Optical Measurement Range: .......... 0.00 to 4.0 Absorbance Units (A)
Photometric Accuracy: ..................... +/- (1% +/-0.010) 0.0 through 1.5 ABS
+/- (2% +/-0.010) 1.5 through 3.0 ABS
Stability:............................................ Drift of no more than 0.005A in 8 hours
Warm up:.......................................... 45 seconds
Light Source: .................................... Halogen, lamp saver feature
Wavelengths: ................................... Standard four filter: 405, 450, 492, and 630nm
6-filter: 405, 450, 492, 545, 600, and 630nm
Filter options from 405nm to 750nm
Filter Type: IAD hardcoat, 10nm half bandpass
Vessel: ............................................. Standard 96 plates or strip trays
•Electronic:
Power Requirements:....................... 100 - 240VAC, 50-60Hz 90W maximum.
All power cords must be approved for the
country of use
PC Connection: ................................ USB Port
Microprocessor:................................ eZ80
Speed: Reads absorbance of 96 wells in approximately 20
seconds
Plate Transport:................................ Stepper motor
Certifications: ................................... CE, ETL listed, NRTL listed (USA/CAN),

10 ChroMate® Microplate Reader Operator’s Manual Rev. Q
Technical Specifications (Continued)
•Software:
PC interface with ChroMate®Manager software included (PC not included)
Features: .......................................... PC interface software (included) with complete
user prompting, error messages, full plate
reporting, automatic interpretation options,
duplicate options, controls locator, curve plotting
and editing.
Format:............................................. CD-ROM and internet upgrades
Operating Systems:.......................... Microsoft Windows® 7, 8.1, 10
Minimum System:............................. Microsoft Windows® 7, 512 MB RAM, USB Port
Secondary menu options: ................ Create/edit protocols, import/export data, LIS
Calculation modes:........................... Single point calibration, point-to-point curve fit,
polynomial regression, linear and sigmoidal
regression (log and linear), cut off absorbance,
multi-point % absorbance.
Additional Features: ......................... User-programmable open system, selectable
plate formatting, reporting
QC options: ...................................... Store control data, print Levey-Jennings or QC
range plots, calculate SDs
USB port:.......................................... USB cable provided
•Physical:
Enclosure: ........................................ All metal enclosure
Dimensions: ..................................... 7.5” x 8.0” x 16.5” (19x20.3x42cm)
Weight: ............................................ 12.5 lbs (5.7 kg)
•Recommended Environmental Conditions
Indoor use
Mains supply voltage ..........................Fluctuations not to exceed + 10% of nominal
voltage
Operating Temperature 18-35°C recommended
Operating Humidity .......................... Less than 85% recommended
Storage Temperature ...................... 10°C to 50°C)
:
Although it may be safe to operate in these conditions, it may not be
suitable for the performance of your tests; check with your test kit supplier

ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q 11
3. Installation
Carefully unpack the instrument, removing it from its plastic bag. Report any damage to your
freight carrier at once.
NOTE: Retain the original packing material for future use in the event that the instrument is
shipped to another location or returned for service.
3.1 Packing List
3.2 Installation Preparation
Instrument
Placement and
Use
Place the instrument on a flat working surface capable of safely
supporting the weight of the instrument, approximately 12.5 lbs
(5.7 kg). Excessive vibration during reading may cause poor
repeatability; thus, a sturdy working surface is required. A
minimum of at least 3 inches (8cm) clearance around the
instrument is required to assure optimal ventilation.
Assure Clean
Power
Availability
The circuit used should be substantially free of large voltage
transients (Kilovolt amp loads) such as large pumps, large
centrifuges, refrigerators and freezers, air conditioners, large
autoclaves, ovens, and dryers. The instrument may fail to operate
normally if the power supply is interrupted. If this occurs, turn the
instrument off for a moment. When the instrument is turned back
on, it will resume normal operation, but data that was not stored in
nonvolatile memory will be lost. If power fluctuations or loss are
frequent, an Uninterruptible Power Supply (UPS) is recommended.

12 ChroMate® Microplate Reader Operator’s Manual Rev. Q
Power Switch
Position
When installing the power cord the unit should be turned off. Look at
the rear panel of the instrument to check that the power switch is in the
O (OFF) position. With power switch off, connect to power supply. A
diagram of the rear panel can be found in Section 3.2 Parts and
Controls.
Power Cord
Requirements
Use only the power cord specified for this product and certified for the
country of use. For 110-120 V units used inside the US use a UL listed
cord set consisting of a minimum 18 AWG, Type SVT or SJT three
conductor cord, maximum 3 meters (10 feet) in length, rated 10 A, 125
V, with a parallel blade, grounding type attachment plug.
For 220-240 V units used inside the US use a UL listed cord as above,
except rated 250 V, with a tandem blade, grounding type attachment
plug. The cord set provided by the manufacturer meets these
requirements.
Safety
Grounding
Do not alter or defeat the safety grounding methods provided. To avoid
the risk of electric shock, the third prong of the AC power plug must be
connected to conductive parts internal to the equipment. Internal
fasteners to grounding points are marked by the IEC 417 symbol
5019 . DO NOT loosen or remove these fasteners or connections.
An alternate method of grounding is provided by connecting the
grounding terminal located on the rear panel, to a suitable ground.
To avoid electric shock, the power cord protection ground conductor
must be connected to ground.
Fuse
Requirements
The fuses are located internally in the instrument; there are two fuses.
Fuse number 1 is located on the main printed circuit board near power
connector J4. It is a 4 Amp, medium acting, 250V, 5 x 20mm, Littlefuse
type 0234004 or equivalent. Fuse number 2 is located on the power
supply. It is a 2.5 Amp, fast acting, 250V, 5 x 20mm, Littlefuse type
21602.5P or equivalent.
Fuse failure is a very rare occurrence and may indicate malfunction
of the equipment requiring service by qualified personnel.
WARNING! AVERTISSEMENT!
FUSE
FUSIBLE
Warning! For continued protection against risk of fire, use the correct
fuse. Disconnect power cord from mains supply before replacing fuses.
Avertissement! Pour la protection continue contre le risque du feu, remplacez
le fusible seulement par une du type spécifique et des estimations courantes.
Démontez l’équipement de l’alimentation d’énergie avant de remplacer le
fusible.

ChroMate®Microplate Reader Operator’s Manual Doc. 4300 Rev. Q 13
3.3 Parts and Controls
The following labeled diagrams illustrate the terms used in this manual to describe parts and
controls of the microplate reader. More details on the operation of each feature are provided in
Section 4-Operating Procedures.
A. Door
B. Indicator light
C. Well A1 location
Figure 3.3-1 Front of Instrument
Figure 3.3-2 Well A1 location
D. Lamp access door
E. Universal Serial Bus (USB) connection
F. External Protective Grounding Terminal
G. Power switch
I=ON O=OFF
H. Power Cord Connection
B
Place the plate into the
instrument with well A-1
at the right rear so that
row 1 is going into the
reader first.
A
C
D
E
F
G
H

14 ChroMate® Microplate Reader Operator’s Manual Rev. Q
Figure 3.3-3 Back of Instrument
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