Advanced Instruments A2O User manual

200005EN Rev12
The A2O®Advanced Automated
Osmometer
User’s Guide
Two Technology Way / 781-320-9000
Norwood, Massachusetts 02062, USA
800-225-4034 Fax:[phone]
aicompanies.com

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Model A2O®Advanced Automated Osmometer User’s Guide
Copyright
This user’s guide is copyrighted by Advanced Instruments with all
rights reserved. Under copyright laws, this guide may not be reproduced
in any form, in whole or part, without the prior written consent of
Advanced Instruments.
© 2018Advanced Instruments
Advanced Instruments has reviewed this guide thoroughly. All material
contained within is believed reliable, but the accuracy and completeness
are not guaranteed or warranted, and are not intended to be representa-
tions or warranties concerning the product described.
Microsoft® and Windows® are registered trademarks of Microsoft
Corporation in the United States and other countries. CONTRAD® is a
registered trademark of Decon Laboratories. All other trademarks are
the property of Advanced Instruments.
Hot-Line® Service
If you have any questions or problems regarding the proper operation of
your instrument, please contact our Hot-Line Service department by
calling one of the following numbers.
•800-225-4034 (toll-free within the USA and Canada)
•+US 781-320-9000 (elsewhere)
•781-320-0811 (fax)

Table of Contents
iii
ix
ix
x
xi
xiii
xvii
1
1
2
4
5
8
9
10
11
12
13
14
14
15
15
4
5
Safe Use
Symbol Conventions
General Cautions
FCC Requirements
Supplies, Parts & Accessories
Foreword: Theory and Technique
Chapter 1 — Installation & Setup
Step 1 — Find a location for the instrument
Step 2 — Unpack the instrument
Step 3 — Remove the shipping stops
Step 4 — Load printer paper
Step 5 — Connect the auxiliary cables
Step 6 — Power up the instrument
Step 7 — Install the osmometer turntable and primary
tube carousel
Step 8 — System fluid and waste bottle setup
Step 9 — Prime the pipettor system
Step 10 — Run a diagnostic test
Step 11 — Set date and time
Step 12 — Set language preference
Step 13 — Check initial factory calibration
Step 14 — Proceed to Chapter 2
Figure 1: Remove Shipping Stop from Pipettor Assembly
Figure 2: Remove Shipping Stop from Osmometer
Module

6
7
9
10
11
12
13
3
17
17
17
18
29
31
32
33
33
34
35
35
27
20
Figure 3: A2O Components and Controls
Figure 4: Load Printer Paper
Figure 5: Back Panel
Figure 6: The Main Screen
Figure 7: Install Osmometer Turntable and Primary Tube
Carousel
Figure 8: The Fluid Level Screen
Figure 9: Ampule Adapter Position
Table 1: A2O Osmometer Packing List
Chapter 2 — Instrument Operation
Hazardous material cautions
Principle of operation
Function of major components
Test sequence
Sample preparation
Repeatability tips
Verifying calibration daily
Sample test procedure
Making a STAT sample measurement
Sample test errors
Changing operating settings
Figure 10: Freezing Chamber
Table 2: Minimum Sample Volumes in Sample Receptacles
Table 3: Barcode Length Requirements
25
Chapter 3 — Standards & Quality Control 37
37
37
38
39
41
41
43
Repeatability and accuracy
Standards and controls
Maintenance of standards
Quality control implementation
Chapter 4 — Calibration
Calibration procedure
Calibration notes
Figure 11: The Calibrate Screen
43
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Model A2O®Advanced Automated Osmometer User’s Guide

Chapter 5 — User Interface 45
45
47
52
52
55
57
62
65
67
69
71
72
73
75
76
77
79
79
83
75
45
46
47
50
51
52
54
56
58
59
60
60
61
A2O graphical user interface
Main operating screen
Menu screen
Test Setup screen
Test Configuration screen
Control Solutions screen
Calibrate screen
System Configuration screen
Users screen
Printer Setup screen
Details screen
Self Tests screen
Positioning screen
Date/Time screen
LAN screen
LIS screen
Assistance screen
Results screen
View Logs screen
Text Input screen
Figure 12: Keypad
Figure 13: A2O Main Operating Screen
Figure 14: The Menu Screen
Figure 15: Sample Tubes Remaining
Figure 16: The Fluid Level Screen
Figure 17: The Test Setup Screen
Figure 18: The Test Configuration Screen
Figure 19: Pre-enter Sample IDs
Figure 20: The Control Solutions Screen
Figure 21: The Edit Control Screen
Figure 22: The Levey-Jennings Chart Screen
Figure 23: The Action on Out-of-Limit Controls Screen
Figure 24: The Control Solutions Log Screen
Figure 25: The Calibrate Screen
62
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Table of Contents

Model A2O®Advanced Automated Osmometer User’s Guide
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74
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85
48
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92
Figure 26: The Reminders Screen
Figure 27: Calibration Log
Figure 28: The System Configuration Screen
Figure 29: The Users Screen
Figure 30: The Printer Setup Screen
Figure 31: The Hardware Details Screen
Figure 32: The Self Tests Screen
Figure 33: The Positioning Screen
Figure 34: The Date/Time Screen
Figure 35: The LAN Setup Screen
Figure 36: The LIS Setup Screen
Figure 37: The Assistance Screen
Figure 38: The Results Screen
Figure 39: The Date Select Screen
Figure 40: The Filter Screen
Figure 41: The View Logs Screen
Figure 42: The Text Input Screen
Table 4: Primary Tube Status Indicator
Chapter 6 — Troubleshooting & Service
Service & maintenance cautions
Obtaining service
Routine maintenance
Shutdown and storage
Troubleshooting checks
Fuse replacement
Figure 43: Syringe Screw
Figure 44: Pipette Cleaning
Figure 45: Sample Probe
93
Figure 46: Connecting the Plastic Syringe to the Waste Bottle Cap 95
96
97
97
98
Figure 47: Clear Database Button
Figure 48: Export Data
Figure 49: Confirm Data Export
Figure 50: Confirm Data Deletion
Figure 51: Fuse Replacement
100

Appendices
Appendix A — Troubleshooting Table 101
Appendix B — Product Specifications 107
Appendix C — Regulatory Notices 109
Appendix D — Printing Test Results 113
Appendix E — Supplemental Laboratory Information System 115
Appendix F — Symbol Definitions 121
Appendix G — Warranty & Warranty Duties 125
Appendix H — Product Disposal and Recycling 129
Appendix I — Service Log 131
Index 133
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Table of Contents

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Model A2O®Advanced Automated Osmometer User’s Guide
Notes:

Safe Use
To reduce the risk of bodily injury, electric shock, fire, and
damage to your instrument, please read and observe the precau-
tions in this User’s Guide.
• If the product is used in a manner not in accordance with the
equipment design, operating instructions or manufacturer's
recommendations, the operation of the product may be
impaired to the extent that a safety hazard is created.
•Do not attempt to perform electrical work if you are not
fully qualified. This manual is not a substitute for electrical
training.
Symbol Conventions
The exclamation point within an equilateral triangle is
intended to alert the user to the presence of important operat-
ing and maintenance (servicing) instructions in the literature
accompanying this product.
The lightning flash with arrowhead symbol within an equi-
lateral triangle is intended to alert the user to the presence of
uninsulated dangerous voltage within the product's enclosure
that may be of sufficient magnitude to constitute risk of elec-
tric shock to persons.
The static symbol within an equilateral triangle is intended
to alert the user to the presence of internal components that
could be damaged by static electricity.
This static symbol is intended to alert the user to the pres-
ence of a specific component that could be damaged by stat-
ic electricity.
ix

This symbol indicates the presence of alternating current (AC).
This symbol indicates the presence of a fuse.
This symbol indicates the presence of protective earth ground.
This symbol indicates the power is ON.
This symbol indicates the power is OFF.
NOTE Additional symbol definitions are available in Appendix F.
General Cautions
• This product should be operated only with the type of power source
indicated on the product’s electrical ratings label. Refer to the instal-
lation instructions included with the product.
• If the power cord provided is replaced for any reason or if an alter-
nate cord is used, the cord must be approved for use in the local
country. The power cord must be approved for the product’s listed
operating voltage and be rated at least 20% greater than the ampere
ratings marked on the product’s electrical ratings label. The cord
end that connects to the product must have an IEC 60320 connector.
• Plug the product into an approved grounded electrical outlet.
• Do not disable the power cord’s grounding pin.
• If an extension cord or power strip is used, make sure that the cord
or strip is rated for the product, and that the total ampere ratings of
all products plugged into the extension cord or strip do not exceed
80% of the cord’s or strip’s rating limit.
Model A2O®Advanced Automated Osmometer User’s Guide
x

• Route power cords so that they will not be walked on, tripped on, or
pinched by items placed upon or against them. Pay particular atten-
tion to the plug, electrical outlet, and the point where the cord exits
the product.
• Do not pull on cords and cables. When unplugging cords or cables,
grasp the corresponding connector.
• Do not install or use this product in any area subject to extreme
short-term temperature variations, or locations that exceed the speci-
fied operating environment temperatures.
• Never use this product in a wet area.
• To avoid injury or fire hazard, do not operate this product in an
explosive atmosphere.
• Do not install or use the product on an unstable, non-level work sur-
face.
• Do not operate this product with the covers removed or unsecured.
FCC Requirements
•WARNING: Changes or modifications to this unit not expressly
approved by Advanced Instruments could void the user’s authority
to operate the equipment.
• This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or televi-
sion reception, which can be determined by turning the equipment
Safe Use
xi

off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
- Consult the dealer or an experienced radio TV technician for
help.
Model A2O®Advanced Automated Osmometer User’s Guide
xii

PART DESCRIPTION
Probe Wiper Rings, Box 50
Disposable 12 x 75 mm Glass Sample Test Tubes, Box 250
Plastic Sample Tubes, 500 Disposable (see note below)
Carousel Adapter Set (containing the following adapters)
Carousel Adapter, 100 mOsm Calibration Standard
Carousel Adapter, 200 mOsm Calibration Standard
Carousel Adapter, 290 mOsm Calibration Standard
Carousel Adapter, 400 mOsm Calibration Standard
Carousel Adapter, 500 mOsm Calibration Standard
Carousel Adapter, 900 mOsm Calibration Standard
Carousel Adapter, 1000 mOsm Calibration Standard
Carousel Adapter, 1500 mOsm Calibration Standard
Carousel Adapter, 2000 mOsm Calibration Standard
Carousel Adapter, 3000 mOsm Calibration Standard
Carousel Adapter, Protinol® 240 mOsm
PART NO.
200221
200220
200223
200399
200376
200377
200378
200379
200380
200381
200382
200383
200384
200385
200534
To order parts and accessories, contact the Advanced Instruments
Customer Service Department by using one of the following num-
bers.
• 800-225-4034 (toll-free within the USA and Canada)
• +US 781-320-9000 (elsewhere)
• 781-320-3669 (fax)
xiii
Supplies, Parts &
Accessories

PART DESCRIPTION
Carousel Adapter, Protinol® 280 mOsm
Carousel Adapter, Protinol® 320 mOsm
Carousel Adapter, Renol™ 300 mOsm
Carousel Adapter, Renol™ 800 mOsm
A2O System Fluid, 500 mL Bottle
Power Cord (specify voltage and country)
User’s Guide
Printer Paper (5 rolls)
100 mOsm/kg Calibration Standard (ten 5 mL ampules)
900 mOsm/kg Calibration Standard (ten 5 mL ampules)
2000 mOsm/kg Calibration Standard (ten 5 mL ampules)
3000 mOsm/kg Calibration Standard (ten 5 mL ampules)
Clinitrol™ 290 mOsm/kg Reference Solution (ten 2 mL
ampules)
Five-Level Osmolality Linearity Set: 100, 500, 900, 1500, and
2000 mOsm/kg (ten 5 mL ampules, two of each level)
Protinol® 3-Level Protein Controls: 240, 280, and 320 mOsm/kg
(nine 3 mL bottles, three of each level)
Renol™ Urine Osmolality Controls: 300 and 800 mOsm/kg
(eight 3 mL bottles, four of each level)
PART NO.
200535
200536
200537
200538
200222
200005UG
FLA835
3LA011
3LA091
3LA201
3LA301
3MA029
3LA028
3MA028
3LA085
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Model A2O®Advanced Automated Osmometer User’s Guide

NOTES
• The plastic sample tube is designed for single use only and must
be discarded after one test. The mechanical impact used to nucle-
ate the sample state change during the test deforms and cracks the
plastic tube. Reusing the cracked tube can result in sample leak-
ing into the cooling chamber. This contaminates the cooling
chamber. It can also produce inaccurate test results or errors.
• Advanced Instruments cannot guarantee the stated instrument per-
formance specifications unless Advanced Instruments brand con-
sumables are used with the instrument. Use of consumables from
manufacturers other than Advanced Instruments is not recom-
mended and may adversely affect system calibration, perfor-
mance, and operation. For information on obtaining these stan-
dards and controls, contact Advanced Instruments or an autho-
rized representative.
Supplies, Parts & Accessories
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Model A2O®Advanced Automated Osmometer User’s Guide
xvi
Notes:

Chapter Name
Foreword
Intended Use
Advanced Osmometers use the technique of freezing point
depression to measure osmolality. Osmolality is the total solute
concentration of an aqueous solution. Osmometers measure the
number of solute particles irrespective of molecular weight or
ionic charge. This information is useful to the following disci-
plines:
Clinical, emergency and sports medicine
Medical research
Biotechnology and pharmaceutical research and
manufacturing
Food and beverage manufacturing
Environmental research and monitoring
Academic research
Industrial applications
For clinical applications, a trained operator can use an osmome-
ter to assist in the diagnosis and treatment of water and elec-
trolyte imbalances. Osmometers test virtually any biological
fluid including, but not limited to, serum, whole blood, plasma,
urine, feces, sweat, and tissue homogenate. Operation of the
instrument is deemed moderate complexity under CLIA and
FDA guidelines.
xvii

Model A2O®Advanced Automated Osmometer User’s Guide
Principles of Freezing-Point Osmometry
When a solute is dissolved in a pure solvent, the following changes in
the solution's properties occur:
•the freezing point is depressed,
•boiling point is raised,
•osmotic pressure is increased,
•vapor pressure is lowered.
These are the so-called "colligative" or concentrative properties of the
solution which, within reasonable limits, change in direct proportion to
the solute concentration (the number of particles in solution).
Of the colligative properties, measurement of the freezing point easily
permits the precise determination of the concentration of an aqueous
solution.
The freezing point of pure H2O is precisely +0.010°C. One mole of a
non-dissociating solute (one that does not dissociate into ionic species),
such as glucose dissolved in 1 kilogram (kg) of water, depresses the
freezing point of the water by 1.858°C. This change is known as the
freezing point depression constant for water. The freezing point depres-
sion also depends on the degree of dissociation of the solute. If the
solute is ionic, each ionic species depresses the freezing point by
1.858°C. For example, if one mole of sodium chloride were to com-
pletely dissociate into two ionic species (Na+ and Cl-) in 1 kg of water,
the freezing point would be depressed by 3.716°C. However, dissocia-
tion is never complete. Interference between solute molecules reduces
dissociation by a factor called the osmotic coefficient.
In a simple solution (i.e., glucose or sodium chloride in water), the
freezing point can be measured and the unit concentration easily deter-
xviii

Foreword
xix
mined from an equation or a reference table. However, the equation is
unique for each solute. In a more complex solution, all ionized and
non-dissociated species contribute to the freezing point depression. The
concentration of each solute cannot be easily determined.
Each of the colligative properties has a similar problem. Though each
of the colligative properties changes in direct proportion to the solute
concentration, each requires a different mode and unit of measurement.
Osmolality is a common unit of concentration measurement that relates
all the colligative properties to each other, and to other concentration
units. Because of its universality, most osmometry applications regular-
ly use osmolality, expressed as "mOsm/kg H2O", as the common unit of
concentration rather than applying further conversion factors.
Instrumentation
Advanced Osmometers measure the freezing point of an aqueous solu-
tion to determine solute concentration. Advanced Osmometers utilize
high precision thermistors to sense the sample temperature, to control
the degree of supercooling and freeze induction, and to measure the
freezing point of the sample. They can routinely determine differences
of ±1 mOsm/kg H2O.
Freezing-Point Thermodynamics
The quickest and most precise way to measure the freezing point of a
solution is to supercool it several degrees below its freezing point. The
solution is unstable in this state. Thus, a mechanical agitation induces
crystallization. The sudden liberation of the heat of fusion causes the
sample temperature to rise toward a plateau temperature, where a liq-
uid/solid equilibrium occurs. The equilibrium temperature is, by defini-
tion, the freezing point of the solution. Managing the plateau tempera-
ture for precise measurement is the basis for several patents issued to
Augustus Fiske.
The duration of the liquid/solid equilibrium phase is a function of the
speed at which the heat of fusion is liberated vs. the speed at which it is
transferred away, or dissipated to the surrounding environment. This

Model A2O®Advanced Automated Osmometer User’s Guide
Standard Freezing Curve
ratio can be slowed to prolong the equilibrium time, giving a distinct
plateau height measurable to 0.001°C.
Sensitive thermistor probes monitor the sample temperature and control
the thermoelectric cooling element. Microprocessor control and auto-
mated operation minimize imprecision due to operator technique.
The following Standard Freezing Curve illustrates the temperature of a
sample as it progresses through the freezing cycle and shows the action
of the instrument at each stage of the cycle.
Definitions
Solution: A homogeneous mixture of solute and solvent in which the
solvent is usually the major component, and the solute is the minor
component.
Concentration: The ratio of solute to a given amount of solvent
(molal), or ratio of solute to solution (molar).
The amount of solute is usually expressed in terms of moles (i.e., gram
molecular weights). One mole = 6.028 x 1023 molecules (Avogadro's
number). One mole of glucose (180.2 g) and one mole of sodium chlo-
ride (58.4 g) each contain Avogadro's number of molecules.
xx