BioMedical Life Systems, Inc. MoleMate User manual

Table of Contents
1. Welcome to MoleMate .....................................................................................................3
2. How SIAscans provide information on Skin Histology ........................................................4
3. Cautions and Warnings ...................................................................................................5
4. How to take a contact SIAscan ........................................................................................7
5. Correct use of the SIAscope V .........................................................................................8
5.1. SIAscan contains unusual black edges .................................................................. 8
5.2. Blotches on images ..............................................................................................8
5.3. Consecutive scans contain a similar mark or spot ...................................................8
5.4. The blood SIAscan appears patchy .......................................................................8
5.5. Colour view has a green and red areas or featureless images ................................. 8
5.6. Unusual coloured dots in the SIAscan ....................................................................9
6. Technical Details .......................................................................................................... 10
6.1. System components ........................................................................................... 10
7. Care of MoleMate system Hardware ............................................................................... 11
7.1. Use Windows to shutdown MoleMate PC ............................................................. 11
7.2. Care during operation ......................................................................................... 11
7.3. Usage conditions ................................................................................................ 11
7.4. Inappropriate conditions ...................................................................................... 11
7.5. Transport and storage ........................................................................................ 11
8. Technical specification .................................................................................................. 12
8.1. SIAscope V ........................................................................................................ 12
9. Electromagnetic Interference ......................................................................................... 13
10. Feedback ................................................................................................................... 14
11. Troubleshooting .......................................................................................................... 15
11.1. Common problems ........................................................................................... 15
12. MoleMate Warranty and Support .................................................................................. 16
13. MoleMate Extended Warranty and Support ................................................................... 17
14. Acknowledgements and Notices ................................................................................... 18
A. Revisions ..................................................................................................................... 18
2

1. Welcome to MoleMate
This document contains important information regarding safe operation of the MoleMate system
Important
Please thoroughly acquaint yourself with the instructions for use before using the MoleMate
system. It is intended to describe the set-up and use of the MoleMate software with the SIA-
scope V.
Important
Before operating the MoleMate software and the SIAscope V it is imperative that the user has
received proper training and is familiar with the Cautions and Warnings section of the manual.
Important
Contact SIAscans are intended to be used as an aid to diagnosis. The user must understand
the meaning and implications of SIAscans before attempting to use them clinically. Papers
written by independent scientists and clinicians describing how SIAscans can aid diagnosis are
available from Astron Clinica.
Further information on each MoleMate module can be found in the appropriate user guides supplied
with your MoleMate system. The documents contain additional detail on how to get the most from
MoleMate. These documents are also available to download from the MoleMate website
(www.molemate.com).
3

2. How SIAscans provide information on Skin Histology
Unlike biopsy, the SIAscans use patented SIA technology to provide an array of quantitative measure-
ments that are displayed in graphical form creating a synthesized ‘image’ showing how the parameter
varies spatially over the skin area.
Contact SIAscans provide information about :
•Concentration :The relative concentration of various skin components, including pigment (such
as melanin), blood and collagen, in the plane of the skin.
•Location :The location relative to the dermal / epidermal junction of selected components.
Each contact SIAscan isolates a single component viewed over an approximately 11mm diameter
area and displays it as a colour bitmap.
4

3. Cautions and Warnings
Warning
The SIAscope V is for EXTERNAL USE ONLY and should not be used on open wounds or
sores.
Warning
The SIAscope V emits light of wavelength 440-960nm. Check with a patient’s existing treat-
ments to ensure compatibility.
Warning
The MoleMate hardware does not generate a significant source of electro-magnetic interfer-
ence. However, the system is not intended for use in areas of high electro-magnetic radiation
(e.g. MRI).
Important
Untrained or unqualified personnel must not use the system. All users must read and under-
stand these instructions fully before using the machine.
Important
Print outs of SIAscans are intended for reference only as they are of reduced resolution and
colours may not be reproduced accurately. Refer to SIAscans displayed in the MoleMate soft-
ware to view fully detailed SIAscans.
Important
Do not disconnect the SIAscope V from the PC when it is scanning.
Important
The SIAscope V contains no user serviceable parts. Please contact Astron Clinica or your loc-
al distributor if your system requires maintenance.
Important
SIAscopy (Contact or Non-Contact) does not function correctly on skin or lesions containing
light absorbing pigments including haemasiderin, escar, scales, jaundice, tattoos, inks, cos-
metics, and other conditions that give rise to the presence of unusual chemicals in the skin. In
very dark lesions such as some Seborrhoric Keratoses, Contact SIAscans may also give incor-
rect information. In these special cases refer to Astron Clinica Limited for advice.
Important
Do not look directly into the light from the SIAscope V. When scanning skin on a patient’s face,
ensure that their eyes are closed.
Important
Take care in handling the SIAscope V. These pieces of equipment are liable to be damaged if
dropped.
5

Important
Take care when packing/unpacking the equipment. The SIAscope V contains delicate com-
ponents which should not be subjected to undue forces. Take care to store each item carefully
in its appropriate carry case.
6

4. How to take a contact SIAscan
Before conducting a scan clean the patient’s skin, removing cosmetics etc with a sterile swab. Check
for unusual conditions that may adversely affect the performance of the SIAscope V as described in
the Cautions and Warnings section.
1. Cleaning the SIAscope V - Before each patient examination, wipe the end of the nose cone with
an Isopropyl wipe.
2. Applying matching fluid - Apply optical matching fluid to the area of skin to be examined. A
single squirt from the applicator should be sufficient. Additional matching fluid is available from
Astron Clinica or your local distributor.
3. Place the SIAscope V on the patient - Using the on-screen viewfinder centre the handset on
the lesion. Pressing down lightly to prevent light from the room contaminating the scan.
4. Hold the SIAscope V still and press the button - Hold the handset still, then press and release
the handset button and wait while the SIAscope V takes its measurements. The software will in-
dicate when scanning is complete.
7

5. Correct use of the SIAscope V
The following symptoms may indicate inaccurate use of the SIAscope V, producing inconsistent con-
tact SIAscans. Check the precautionary notes below and repeat the scan to ensure the SIAscans con-
tain accurate indications.
• SIAscan contains unusual black edges
• Blotches on images
• Consecutive scans contain a similar mark or spot
• Blood SIAscan appears patchy
• Colour view has green and red areas or featureless images
• Unusual colored dots in the SIAscan
Important
Refer to the Cautions and Warnings section for limitations relating to unusual skin pigmenta-
tion conditions such as jaundice, tattoos, inks and cosmetics.
5.1. SIAscan contains unusual black edges
A shadow effect around the edge of the scan area, normally on the Blood or Collagen SIAscans, is
likely to have been caused by light ingress during scanning. To rectify the problem, repeat the scan
ensuring the window on the handset is fully in contact with the skin to exclude light.
5.2. Blotches on images
Blotches may be caused by bubbles in the matching fluid. The Blood SIAscan scan highlights these
bubbles particularly well. To rectify the problem, clean off the current layer of matching fluid, apply a
thinner layer and re-take the scan.
5.3. Consecutive scans contain a similar mark or spot
A re-occurring mark or spot on the scans is likely to have been caused by dirt or debris on the win-
dow. It is important to ensure that the window is always clean. It is often difficult to spot this kind of
problem when heavily featured or freckled areas are being scanned. One method recommended to
avoid this problem is to wipe the end of the handset after every scan with an Isopropyl wipe. This
serves to both clean and sterilize the window. (Suitable Isopropyl wipes available from Astron Clinica
and its distributors).
5.4. The blood SIAscan appears patchy
A patchy Blood SIAscan is often a symptom of excessive pressure being applied to the skin. This
pressure tends to whiten the skin surface pushing the blood into a blotched formation.
5.5. Colour view has a green and red areas or featureless images
This is most likely caused by handset movement during scanning. Ensure that the lesion is steady on
the viewfinder before starting a scan, and hold the handset in position until after the scan finishes. Ex-
cessive use of optical matching fluid can make it difficult to keep the handset still.
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5.6. Unusual coloured dots in the SIAscan
In some circumstances MoleMate cannot process the data collected. In areas where this occurs the
SIAscans contain bright dots, which are easily distinguishable. Such scans should be retaken. If the
dots appear consistently ensure that the skin is clean and free of cosmetics. Refer to the Cautions
and Warning section.
9

6. Technical Details
6.1. System components
The MoleMate system consists of a SIAscope V.
The SIAscope V consists of a unit with a 11mm diameter sensing window. It incorporates control but-
tons that allow navigation through the MoleMate software. The SIAscope V is supplied with a stand-
ard USB 2.0 cable.
10

7. Care of MoleMate system Hardware
7.1. Use Windows to shutdown MoleMate PC
Data corruption can occur if power is suddenly removed from the system. Always use Windows to turn
off your computer.
7.2. Care during operation
Before each patient examination, wipe the handset window with an Isopropyl wipe.
7.3. Usage conditions
The MoleMate hardware should only be used in the following conditions;
• Temperatures between 10°C and 30°C
• Relative humidity between 30% and 80%
The MoleMate hardware is not intended for use in areas of high electromagnetic radiation(e.g MRI
and CT scanning rooms)
7.4. Inappropriate conditions
The MoleMate hardware should NOT be used in the following conditions:
• Avoid use in direct sunlight and very brightly lit rooms
• Avoid use in areas of dust concentration
• Avoid use in areas of extreme vibration
7.5. Transport and storage
The SIAscope V should be stored and transported in the following conditions
• Temperatures between 10°C and 40°C
• Relative humidity between 30% and 80%
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8. Technical specification
8.1. SIAscope V
•Function - Non-invasive skin imaging device displaying the distribution and relative concentration
of blood, pigment (such as melanin), and collagen within the papillary dermis and/or epidermis.
Data is displayed as colour bitmaps known as SIAscans.
•Sensing technology - Spectrophotometric Intracutaneous Analysis
•Sensor - Hand held sensor with a 11mm diameter sensing area, linked by a standard USB 2.0
cable to the system unit.
•Emitted wavelengths - 440nm to 960nm
•Resolution - Features larger than 25 microns
•Scan time - Approximately 3 seconds data collection, 3 seconds data processing
•Data display format - Processed data displayed as colour bitmaps (SIAscans) representing relat-
ive concentration and distribution of selected chromaphores.
•Reference image format - Enhanced colour ELM (dermatoscopic) image. Image calibrated for re-
peatability and optimized for maximum colour discrimination in both light and dark areas of the im-
age.
•Calibration - Factory Calibrated
•Dimensions - 240mm in length x 65mm in diameter at its widest point.
•Weight - 250g
•Viewfinder - Colour viewfinder mode allows accurate positioning of the sensor on the skin.
•Hygiene - Easily disinfected sensor window. Wipe clean with an Isopropyl wipe before each scan.
•Power supply - Power provided via the standard USB 2.0 connection.
12

9. Electromagnetic Interference
The SIAscope V has been tested to ensure full compliance with the relevant sections of EN60601
(Electromagnetic Compatibility and Safety of Medical Electrical Equipment).
13

10. Feedback
At Astron Clinica Ltd, we strive to produce the highest quality products and welcome your feedback. If
you have comments or suggestions about MoleMate please do not hesitate to contact us.
If you have a technical query, please contact support:
[email protected]
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11. Troubleshooting
11.1. Common problems
There are a number of foreseeable faults or problems that may affect the operation of MoleMate.
These problems are often easy to solve. The following table highlights these problems, suggests a
check to diagnose them, and then suggests an action to amend the fault.
Further support information can be found on the MoleMate website :
www.astronclinica.com/support
Table 1. Trouble shooting
Problem Check Action
Artifact on all scans. The Handset window is clean. Clean the SIAscope V window
with an Isopropyl wipe.
SIAscope V will not connect Check that the SIAscope V has
been connected properly to a
USB 2.0 port.
Try connecting to another USB
2.0 port.
Droplets of water on the inside
of the handset window. Are the droplets on the inside of the scanning window? If not
clean the window.
If moisture is on the inside of the
window, leave the handset in a
warm room for the moisture to
evaporate. If the problem per-
sists then contact technical sup-
port.
Viewfinder screen is black. Examine the handset and note if
there is a blue light eminating
from the end. If there is not it is
likely that the illumination has
failed.
Contact technical support.
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12. MoleMate Warranty and Support
Features
• Comprehensive cover of the components of the MoleMate product is included in the warranty, as
long as they have been used in accordance with the terms and conditions in the warranty docu-
ment. Items included are: MoleMate SIAscope V Handset and associated components; MoleMate
software.
• A dedicated technical support team will be available for UK and EMEA customers during UK office
hours (excluding Bank Holidays) to help with any issues relating to the installation and operation of
the MoleMate Product. Astron Clinica can be contacted by phone on [phone] or via
email [email protected]
• A dedicated technical support team will be available for Australian and ASIA-PAC customers dur-
ing office hours 9:00 am. and 5:00 pm AEST (Australian Eastern Standard Time) excluding public
holidays to help with any issues relating to the installation and operation of the MoleMate Product.
Astron Clinica can be contacted by phone on 1300 889 340, outside Australia (61) [phone]
or via email [email protected]
• If in the event that the MoleMate SIAscope V handset needs to be shipped back to Astron Clinica
the cost will be met by Astron Clinica. Approval must be sought from Astron Clinica before any
shipment of the device is made.
• Any components found to be faulty under the terms and conditions of the contract will be repaired
or replaced at no cost to the customer.
• No charge for parts, labour, during the warranty period.
• Upgrades to the MoleMate software and relevant applications, within the current major version of
the software that is released within the valid warranty period.
Limitations
• As detailed in the MoleMate user documentation.
16

13. MoleMate Extended Warranty and Support
Features
• Comprehensive cover of the components of the MoleMate product is included in the warranty, as
long as they have been used in accordance with the terms and conditions in the warranty docu-
ment. Items included are: MoleMate SIAscope V Handset and associated components; MoleMate
software.
• A dedicated technical support team will be available for UK and EMEA customers during UK office
hours (excluding Bank Holidays) to help with any issues relating to the installation and operation of
the MoleMate Product. Astron Clinica can be contacted by phone on [phone] or via
email [email protected]
• A dedicated technical support team will be available for Australian and ASIA-PAC customers dur-
ing office hours 9:00 am. and 5:00 pm AEST (Australian Eastern Standard Time) excluding public
holidays to help with any issues relating to the installation and operation of the MoleMate Product.
Astron Clinica can be contacted by phone on 1300 889 340, outside Australia (61) [phone]
or via email [email protected]
• If in the event that the MoleMate handset needs to be shipped back to Astron Clinica the cost will
be met by Astron Clinica. Approval must be sought from Astron Clinica before any shipment of the
device is made.
• Any components found to be faulty under the terms and conditions of the contract will be repaired
or Replaced at no cost to the customer.
• No charge for parts, labour, during the warranty period.
• Upgrades to the MoleMate software and relevant applications, within the current major version of
the software that is released within the valid warranty period.
Limitations
• The warranty will only be in force after payment of the invoice for the extended warranty period
has been received in full by Astron Clinica ltd
• As detailed in the MoleMate user documentation
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14. Acknowledgements and Notices
SIA, SIAscanner, SIAscope, SIAscan, SIAscopy, COSMETRICS, Astron Clinica, SIAscope V,
MoleMate and Powered by SIAscopy are registered trademarks of Astron Clinica Ltd.
Microsoft and Windows are registered trademarks of Microsoft Corporation.
The information contained in this manual is subject to change without notice.
Astron Clinica Ltd makes no warranty of any kind with regard to this material, including but not limited
to, the implied warranties of merchantability and fitness for a particular purpose.
Astron Clinica Ltd shall not be liable for any errors or for incidental or consequential damages in con-
nection with the furnishing, performance, or use of this material.
All rights reserved. Reproduction, adaptation, or translation of this document is prohibited without prior
written permission of Astron Clinica Ltd, except as allowed under the copyright laws.
No part of this document may be photocopied, reproduced or translated to another language without
the prior written consent of Astron Clinica Ltd.
The SIA technology is protected by patents in most major territories around the world including Aus-
tralia (Patent No. 725 766), UK (Patent No. 2 334 099) and USA (Patent No. 6 324 417).
The MoleMate software is subject to a separate license agreement and must not be copied or distrib-
uted to third parties.
Copyright Astron Clinica Limited 2006.
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A. Revisions
Table A.1. Revisions
Revision No Revision Description Date
Revision 0.1 First draft composed 05/07/2006
Revision 0.2 Final version for printing 01/09/2006
19