CariFree CariScreen User manual

Operators Manual
Version 1.4
www.carifree.com
CariScreen is a trademark of Oral BioTech and CariFree is a registered trademark of Oral BioTech in the United States.
Printed and distributed by Oral BioTech Albany, Oregon 97321 USA, 866-928-4445.
25056 PDF 6.16
Caries
Susceptibility
Testing Meter
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VERSION 1.4
MARCH 2016
The CariScreen Caries Susceptibility Testing Meter
is manufactured for Oral BioTech.
Patent pending.
All rights reserved. No part of this manual may be reproduced,
stored in a retrieval system, or transmitted, by any means or in
any form, without the prior permission of Oral BioTech.
The information contained in this manual is subject to change
without notice. Oral BioTech assumes no responsibility for errors
that may appear in this document.
CariScreen is a trademark of Oral BioTech. CariFree is a registered trademark of Oral BioTech in the
United States. Printed and distributed by Oral BioTech Albany, Oregon 97321 USA 866.928.4445.
OPERATORS MANUAL
CariScreen
Caries Susceptibility
Testing Meter
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The following symbol is used in this manual:
The precautions to be observed relate to the transportation and
use of all types of solid state electrical/electronic instrumentation
and to the handling of the CariScreen Swab devices.
These precautions are outlined on the next page:
Description: CAUTION / WARNING
OPERATING PRECAUTIONS AND LIMITATIONS
IMPORTANT: Oral BioTech products are designed and constructed
to be safe and without risk to health when properly used (in
accordance with the supplied documentation, etc.) and when the
operating precautions outlined in this document are fully observed.
IMPORTANT
IT IS ESSENTIAL THAT THE USER OF THIS MANUAL IS
AWARE OF THE POTENTIAL HAZARDS ASSOCIATED WITH
THE UNIT AND ITS ACCESSORIES.
ALL OPERATIONS SHOULD BE FAMILIAR WITH THE SAFETY
PRECAUTIONS AND WARNINGS GIVEN IN THIS SECTION
PRIOR TO ATTEMPTING TO OPERATE THE UNIT.
IF THE UNIT IS USED IN A MANNER NOT SPECIFIED BY
THE MANUFACTURER, THE PROTECTION PROVIDED BY
THE EQUIPMENT MAY BE IMPAIRED.
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WARNING: Do not use the unit in any area which has
been or is thought to have been exposed to explosive
or ammable gases or vapors.
CAUTION: Do not expose the unit to extremes of
temperature (see section 9), and minimize any exposure
to electrostatic charges.
CAUTION: Care should be taken not to drop the unit
or subject it to rough physical handling.
WARNING: Use only non-rechargeable alkaline
batteries, or rechargeable NiMH or NiCD batteries,
of types specied in section 9.
WARNING: Do not use batteries with individual cell
voltages greater than 1.65V, as this will cause permanent
damage to the unit.
CAUTION: Old batteries should be disposed of in
accordance with your local regulations.
BATTERIES
UNIT HANDLING
USE AND INSERTION OF CARISCREEN SWAB DEVICES
OPERATING ENVIRONMENT AND ELECTROSTATIC
PRECAUTIONS
CAUTION: Refer to the CariScreen Swab data sheet and
kit insert for details before using the device, and observe
all federal, state and local environmental regulations.
CAUTION: Do not force CariScreen Swab devices into
the unit. Do not attempt to insert any object other than
an approved CariScreen Swab device into the unit.
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REGULATORY LIMITATIONS OF USE
The CariScreen Caries Susceptibility Testing Meter has been designed
to meet the following general, safety and EMC requirements:
The CariScreen Caries Susceptibility Testing Meter is manufactured
under ISO 9001 controls.
DECLARATION OF CONFORMITY
The CariScreen Caries Susceptibility Testing Meter has been designed
in accordance with, and satises the requirements of, article 11 of
the Low Voltage Directive 73/23/EEC as realigned by 93/68/EEC
on the harmonization of the laws of the Member States relating to
electrical equipment designed for use within certain voltage limits, to
the essential requirements of BS EN 61010-1:2001.
CAUTION: Do not use excessive force when pressing
any of the buttons on the unit’s keypad.
WARNING: There are no Operator serviceable parts
inside the unit. Removal or opening of the unit’s casework
will void the warranty.
• Low Voltage Directive 73/23/EEC
• EMC Directive 89/336/EEC
• BS EN 61010-1:2001, IEC 61010-1:2001
• UL 61010B-1
• CAN/CSA C22.2 1010.1-92
• EN 55022:1998
• EN 61000-4-2:1995
• EN 61000-4-3:1995
• FCC Class A - Sub Part J
GENERAL
SAFETY
EMC
CAUTION: Ensure that the CariScreen Swab device is
clean and dry before inserting it into the unit.
UNIT CASEWORK
KEYPAD BUTTONS
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The CariScreen Caries Susceptibility Testing Meter has been type
tested by EMC Projects Limited (a UKAS and CAA approved test
facility and UK appointed Notied Body), and issued a Certicate of
Compliance No. 5569/03 to the following EMC standard:
EN61326 : 1997
Covering:
Radiated Emissions (EN 55022 : 1998)
Electrostatic Discharge (EN 61000-4-2 : 1995)
Radiated Immunity (EN 61000-4-3 : 1995)
Satisfying the EMC Directive(s) 89/336/EEC and 92/31/EEC as
realigned by 93/69/EEC.
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1Introduction ..................................1
1.1 Principle of Operation ..........................1
2Basic Unit Operation.............................2
2.1 Unit Description ..............................2
2.2 Keypad Symbols..............................3
2.3 Display Layout and Icons........................ 4
2.4 Fitting the Batteries ...........................5
2.5 Turning On the Unit ...........................6
2.6 Low Battery Indicator ..........................6
2.7 Internal Self-Calibration ........................7
2.8 Ready for Use ...............................8
2.9 Turning the Unit Off ...........................8
2.10 Power Saving Standby Mode ....................9
3Sample Measurements and Test Results .............9
3.1 Turning On the Unit ...........................9
3.2 Internal Self-Calibration ........................9
4Setup Menu Options ............................11
4.1 Result Thresholds ............................ 11
4.2 Viewing Stored Test Results ..................... 12
4.3 Erasing the Test Results Memory ................. 12
4.4 Viewing Statistics and At Risk Readings............. 13
4.5 Setting the Clock Time and Date ................. 14
4.6 Adjusting the LCD Contrast ..................... 15
TABLE OF CONTENTS
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5Operator Maintenance ..........................15
5.1 Cleaning the Casework ....................... 15
5.2 Replacing the Batteries ....................... 16
5.3 Cleaning and Replacing the Protective Pocket ........ 16
6 Troubleshooting ...............................18
6.1 Unit Beeps ................................ 18
6.2 Troubleshooting Tips ......................... 19
6.3 Unit Error Codes ............................ 21
7Warranty And Returns ..........................23
7.1 Warranty Duration .......................... 23
7.2 Particular Exclusion .......................... 23
8Glossary of Terms and Abbreviations...............24
9Technical Specications .........................25
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INTRODUCTION
The CariScreen system is intended to provide a fast, easy
screening test for dental caries via the use of an ATP
bioluminescence test.
The CariScreen system consists of two elements: the CariScreen
hand-held Caries Susceptibility Testing Meter and the disposable
CariScreen Caries Susceptibility Testing Swab.
This Operator’s Manual provides a detailed description of how to
use the CariScreen Meter, and how to handle maintenance and
troubleshooting.
For full details on the CariScreen Swab device, please refer to the
CariScreen Swab kit insert.
1
.1 PRINCIPLE OF OPERATION
The CariScreen Swab device uses bioluminescent chemistry
technology to convert an invisible concentration of ATP (present in
the swabbed sample) into a visible light output.
The low-level light output is measured by the CariScreen Meter to
produce both a quantitative and qualitative result.
The quantitative result is a number in the range 0 to 9999,
expressed in terms of Relative Light Units – RLUs.
Although Relative Light Units are not a tangible unit of light
measurement (such as lux), they do provide a real measure of the
amount of light output by the ATP bioluminescent test.
In this application, 1 RLU is roughly equivalent to 1 fmol of ATP.
1
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