CarieScan PRO User manual

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 DFU003, Issue H rev2
CarieScan PRO
User Manual

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 DFU003, Issue H rev2
Declaration of Conformity
We herewith declare that the generic family of devices, Hand Held Caries Detection Devices, meet the
provisions of the Council Directive 93/42/EEC for medical devices and the UK Medical Devices Regulations SI
1994/3017.
The Technical File is retained in the premises of the manufacturer.
Primary Product Safety Standards Fulfilled
IEC / UL 60601-1 General Requirements for Safety
CSA-C22.2 No.601.1-M90 Part 1 General Requirements for Safety
CarieScan PRO and the CarieScan logo are trademarks of CarieScan Ltd and are not to be copied or
reproduced in any format.
The CarieScan PRO is protected by UK Patent 2385136B and Registered Community Designs
EC000680467-0002. Equivalent patent and design applications are pending in other countries.

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 DFU003, Issue H rev2
CONTENTS
1Getting Started................................................................................................................................................. 1
1.1 The CarieScan PRO™....................................................................................................................................................... 1
1.2 Taking a measurement on Occlusal and Free Smooth Surfaces ..................................................................................... 2
2Product Overview ............................................................................................................................................ 5
2.1 Box Contents List ............................................................................................................................................................... 6
2.2 CarieScan PRO.................................................................................................................................................................. 7
2.3 Soft Tissue Cable ............................................................................................................................................................... 8
2.4 Charging Cradle and Stand ............................................................................................................................................... 8
2.5 Power Supply Unit.............................................................................................................................................................. 8
2.6 Cable Test Adaptor ............................................................................................................................................................ 8
2.7 Sensor Pack ....................................................................................................................................................................... 8
3INSTALLATION / ASSEMBLY.......................................................................................................................... 9
3.1 Charging the CarieScan PRO............................................................................................................................................ 9
3.2 Connections to Compatible Accessories via Bluetooth®................................................................................................... 9
4DEVICE START UP........................................................................................................................................... 9
4.1 Start Up .............................................................................................................................................................................. 9
4.2 Initialisation......................................................................................................................................................................... 9
4.3 Standby ............................................................................................................................................................................ 10
4.4 Measurement mode ......................................................................................................................................................... 10
4.5 Navigation Mode .............................................................................................................................................................. 10
4.6 System Health Check....................................................................................................................................................... 11
5CARIES DETECTION PROTOCOL................................................................................................................. 12
5.1 Caries Detection Evaluation Scale .................................................................................................................................. 12
5.2 Setting up the device........................................................................................................................................................ 13
5.3 Preparing the patient........................................................................................................................................................ 13
5.4 Taking a measurement on Occlusal and Free Smooth Surfaces ................................................................................... 13
6CLEANING AND MAINTENANCE.................................................................................................................. 15
6.1 General............................................................................................................................................................................. 15
6.2 Service.............................................................................................................................................................................. 15
6.3 Storage conditions ........................................................................................................................................................... 15
7Important Information.................................................................................................................................... 16
7.1 Intended Use .................................................................................................................................................................... 16
7.2 Indications for use ............................................................................................................................................................ 16
7.3 Restrictions on Use .......................................................................................................................................................... 16
7.4 Contraindications ............................................................................................................................................................. 16
7.5 Warnings .......................................................................................................................................................................... 16
7.6 Precautions ...................................................................................................................................................................... 16
7.7 Infection control................................................................................................................................................................ 16
8CERTIFICATIONS........................................................................................................................................... 17
9WARNINGS & PRECAUTIONS ...................................................................................................................... 18
9.1 General............................................................................................................................................................................. 18
9.2 Label Glossary ................................................................................................................................................................. 18
9.3 Classification .................................................................................................................................................................... 19
10 FURTHER INFORMATION.............................................................................................................................. 19
10.1 Product support................................................................................................................................................................ 19
10.2 Battery information ........................................................................................................................................................... 19
10.3 LCD Glossary................................................................................................................................................................... 20
10.4 Troubleshooting................................................................................................................................................................ 20

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 1 DFU003, Issue H rev2
1 Getting Started
1.1 The CarieScan PRO™
The CarieScan PRO™ enables dentists to evaluate posterior (molar and premolar) teeth using AC Impedance
Spectroscopy (ACIST) by providing information about whether the tooth is healthy, in the early stages of decay or
already significantly decayed (see also Section 7). The PRO assesses the occlusal surfaces and the free-smooth
surfaces of teeth.
The system consists of the CarieScan PRO handpiece, a Soft Tissue Cable for attaching the soft tissue contact (lip
clip) to the PRO, and a Sensor. The PRO uses a disposable sensor that resembles a small toothbrush. The sensor
is held against the tooth to be examined and the measurement takes about four seconds to complete then the
result is displayed.
Note:
For full details see Section 2
The CarieScan PRO
Power
(on/off)
colour LED
results pyramid
on both sides
(b)
charging
contacts
soft tissue
cable socket
Enter
(start measurement)

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 2 DFU003, Issue H rev2
1.2 Taking a measurement on Occlusal and Free Smooth Surfaces
Placing the sensor on to the CarieScan PRO
Prepare the CarieScan PRO
1. After taking suitable cross-infection precautions
(see our website at www.cariescan.com for our
recommendation of barriers) hold the CarieScan
PRO with the display facing you and push the
Tufted Sensor onto the CarieScan PRO with the
tuft facing away from you, locating it with a click.
2. Switch on the PRO by holding down the ‘Power’
button until the device starts up.
Note: Use the Tufted Sensor for measurement of occlusal and
accessible smooth surfaces only.
3. Open the sensor blister pack by peeling off the
Tyvek lid.
Note:
Care must be taken if any plastic sheathing is used for cross-infection control purposes. Ensure that it does not
prevent electrical contact between the end of the CarieScan PRO and the contacts inside the sensors.
4. The LCD will show ‘RdY’ (ready), the Occlusal and Smooth surface icons will be shown.
Prepare the patient
5. Place the PRO in its stand while you ensure the
surface of the tooth to be measured is free from any
plaque and debris.
6. Connect the Soft Tissue Contact (lip clip) to the
socket of the cable.
7. Firmly connect the plug of the soft tissue cable into
the socket at the side of the CarieScan PRO.
8. Gently place the curled end of the Soft Tissue
Contact over the lower lip of the patient.
9. Dry the tooth site to be measured for 5 seconds with
a 3-in-1 syringe to remove any pooled fluid.
Note: that drying time is based on standard air
pressure of 40psi.
Measurement of occlusal surface

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 3 DFU003, Issue H rev2
Record the result and move on to another site
Note:
If there is a bad connection or improper site preparation the PRO may not provide a measurement value.
14. With the measurement complete the sensor can be removed from the tooth surface, the result will remain
visible on the displays until the next tooth site is detected. Record the last result as required and select
another site to measure.
15. Record the last result as required and select another site to measure.
16. Should the sensor become contaminated or waterlogged, you should replace the sensor with a new one
before continuing.
Finishing up
17. The Measurement mode (indicated by the blue flashing LED) automatically restarts after 3 seconds, and
subsequent measurement will begin when the CarieScan PRO detects when the sensor is on a tooth.
18. Take a new measurement by returning to step 9. (Further drying may not be necessary if repeating
measurements on the same site.)
19. Terminate the measurement process by pressing any button on the Keypad for about 1s.
20. When measurements on the patient are complete:
•to remove the sensor from the CarieScan PRO, squeeze the sensor on the side grips to release the
catch and remove from the device.
Measurement of smooth surface
Measure the site
10. Press the ‘Enter’ button to start measuring.
11. The blue LED on the pyramid will flash indicating
that the CarieScan PRO is in measurement mode.
12. Place the sensor firmly onto the chosen occlusal
or smooth surface and a measurement will
automatically be taken. During the measurement
4 audible tones will be heard before the result is
displayed.
13. On completion of the measurement the result is
presented by a further sequence of beeps and the
colour pyramid classification will light displaying
the caries detection level (Section 5.1).

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 4 DFU003, Issue H rev2
•all sensors must be disposed as sharp contaminated waste. All such waste must be placed in a suitable
receptacle marked as biohazard, conforming to the required regulations.
•the CarieScan PRO and Soft Tissue Cable should be wiped down with alcohol-based wipes.

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 5 DFU003, Issue H rev2
2 Product Overview
The CarieScan PRO has a number of advantages over other measuring / visualisation systems. The absence of X-
rays has safety advantages and allows increased frequency of monitoring. Most importantly the accuracy of results
sets the system apart from other diagnostic methods. CarieScan PRO is 92.5% accurate at detecting both sound
and carious teeth, minimising false positive or false negative results.
The PRO enables earlier and more accurate detection of “early” caries lesions which are not clearly visible to the
human eye enabling remedial (preventive) treatment to be initiated. It also enables detection of the more extensive
“hidden” lesions extending into dentine which can be missed by even the most careful examiner. Unlike
competitors, the PRO is not affected by optical factors such as staining or discoloration of the tooth. The CarieScan
PRO provides a qualitative value based directly on the disease state, rather than the indirect optical properties of
the tooth or surrogate markers such as bacterial breakdown products.
The impedance of a healthy tooth is very high due to relatively low ionic conduction. However, as a tooth
demineralises it starts to lose some of its regular structure from beneath the tooth’s surface zone and increasingly
larger pores are formed as minerals are eluted out. If the lesion progresses, the pores can connect with each other
and the tooth becomes a mix of highly conductive parts (the fluid filled pores) and the low conductive enamel, so
impedance decreases. As the decay progresses, dentine becomes involved and cavities are formed, the
impedance falls further.
The key to evaluating dental tissue in this way has been to pass a very
low current (undetectable to the patient) through a tooth and to measure
the impedance of the flow of charge passing through it.
The variance in signals between the different stages of decay is
significant. The impedance measured in a healthy tooth is significantly
greater than that of a tooth that is demineralising which is itself
significantly greater than that of a tooth with a cavity. As a result the
sensitivity (ability to find caries when it is present) and specificity (ability
to detect healthy tissue, or lack of false positives) of the ACIST system in
distinguishing these different stages is very high.

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 6 DFU003, Issue H rev2
2.1 Box Contents List
Please review the contents below and ensure all the components are present. If there are any missing
components please refer to Product Support (Section 10.1).
Part
Number
Figure Item See Section
CP-SYS-01
CarieScan PRO
system
2.1
CP-STC-01
Soft Tissue Cable 2.3
CP-STD-01
Display Stand 2.4
CP-CHG-01
Charging Cradle 2.4
CP-PSU-01
Power Supply Unit 2.5
CP-TSN-01
Cable Test Adaptor 2.6

CarieScan PRO User Manual
© Copyright CarieScan Ltd 2008 7 DFU003, Issue H rev2
2.2 CarieScan PRO
2.2.1 General
The CarieScan PRO has a keypad, LCD symbol display, colour LEDs and a soft tissue cable socket. The PRO
includes Bluetooth® for future connectivity. Battery charging is achieved via the charging cradle.
2.2.2 Audio response
The CarieScan PRO provides audio feedback. Sounds are used to indicate:
•completion of internal test at startup
o2 short beeps for OK
o2 long beeps for fail
•the completion of a measurement:
oGreen: Single beep
o1-99: 3 beeps
oRed: 6 rapid beeps
•the completion of System Health Check
o2 short beeps for OK
o2 long beeps for fail
Power
(on/off)
colour LED
results pyramid
on both sides
(b)
charging
contacts
soft tissue
cable socket
Enter
(start measurement)