AngioDynamics UK AS597 RFID Transmitter to identify adjacent accessories User Manual 359523
AngioDynamics UK Limited RFID Transmitter to identify adjacent accessories 359523
Manual
DIODE LASER
Operator Manual Addendum
(Automatic Laser Configuration)
Version 1.0 US September 2003 MAN / 17 / 0065 US
[Not all products in this manual are available in all countries.]
Manufactured in the United Kingdom by DIOMED Limited
DIOMED is a Registered Trademark of DIOMED Ltd. 2003 DIOMED Ltd.
DIOMED 15/30PLUS
- 2 -
CONTENTS
1 Introduction ...................................................................................................................................... 3
2 Technical Specifications................................................................................................................... 4
2.1 Labelling ................................................................................................................................... 5
3 Using the ALC system...................................................................................................................... 6
3.1 Single-use Fiber........................................................................................................................ 6
3.2 Multiple-use Fiber ..................................................................................................................... 8
3.3 Spot Handpiece ........................................................................................................................ 9
4 Emergency Override ...................................................................................................................... 10
4.1 Session Fault Override............................................................................................................ 11
4.2 Resetting the Emergency Override ......................................................................................... 12
5 Error Messages.............................................................................................................................. 13
6 Trouble-shooting ............................................................................................................................ 13
7 Ordering Information ...................................................................................................................... 14
DIOMED 15/30PLUS
- 3 -
1 INTRODUCTION
This document is an addendum to the “DIOMED 15PLUS & DIOMED 30PLUS Diode Laser Operator
Manual” and must be read in conjunction with that manual.
The DIOMED Automatic Laser Configuration (ALC) system provides a means of identifying the fiber that
is connected to a DIOMED 15/30PLUS. A small identification device is located inside the grip at the SMA
end of the fiber and this is read by the DIOMED 15/30PLUS whenever it is switched on and a fiber
connected to it. The identification device is read by means of a low power communication system called
Radio Frequency Identification, or RFID. It holds the following information:
The type of fiber This tells the system what type of fiber or accessory has been
connected to it.1
The date when the sterility of
the fiber expires
If the sterility expiration date is earlier than the current date in
the internal clock of the DIOMED 15/30PLUS then the fiber is
invalid and cannot be used.
How many times the fiber
may be safely used
The number of “uses” 2 is decreased each time the system is
used with the connected fiber. When the figure reaches zero,
the fiber becomes invalid and cannot be used again.
The ALC system therefore provides the following benefits:
• Single-use fibers cannot be re-used, minimizing the risk of patient infection or fiber failure
• Fibers that have passed their sterility expiration date cannot be used, minimizing the risk of
patient infection.
• The number of available “uses”, subject to satisfactory calibration, for Multiple-use and Spot
Handpiece fibers is displayed on the screen, giving a clear indication of when a fiber is due for
replacement.
• Operation of the DIOMED 15/30PLUS is simplified, because the ALC system is able to
automatically recognize devices independently of the user – for example, the type of Spot
Handpiece.
In order to obtain full advantage of the DIOMED ALC system you should always use fibers supplied by
DIOMED or fibersdirect.com. A list of the currently available fibers that are compatible with the ALC
system is provided in section 7 below.
1 The system will read the fiber’s data if the power is on and an ALC system fiber is connected or if the
DIOMED 15/30PLUS is powered up with an ALC system fiber already connected.
2 The number of available “uses” is only decreased once per procedure and only after the DIOMED
15/30PLUS has been fired. Subsequent firing of the DIOMED 15/30PLUS during a continuous procedure
will not result in the number of available “uses” being further decreased.
DIOMED 15/30PLUS
- 4 -
2 TECHNICAL SPECIFICATIONS
The following technical specifications are in addition to those listed in the “DIOMED 15PLUS & DIOMED
30PLUS Diode Laser Operator Manual”.
ALC System Operating Frequency 125 kHz ± 5 kHz
ALC System Operating Range Maximum of 40 mm from the laser output port
Standards
FCC 47 Part 15c
Canadian RSS-210
EN 300 330-1, EN 300 330-2, EN 301 489-1,
EN 301 489-3
This product complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause
undesired operation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area may cause harmful interference in which case the user
will be required to correct the interference at their expense.
Modifications not expressly approved by the manufacturer could void the user’s authority to operate the
equipment under FCC rules.
DIOMED follows a policy of continual improvement and reserves the right to alter the design or
specification without notice.
The specification may vary for different countries.
DIOMED 15/30PLUS
- 5 -
2.1 Labelling
The following labels are in addition to those listed in the “DIOMED 15PLUS & DIOMED 30PLUS Diode
Laser Operator Manual”.
FCC Declaration Label
Intentional Radiator Label
This device contains an intentional radiator part number
This product complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired operation.
This device complies with Canadian RSS-210
AS/597
FCC ID: RBQAS597
Canada IC: 4690A-AS597
GROUNDING RELIABILITY CAN ONLY BE
ACHIEVED WHEN EQUIPMENT IS
CONNECTED TO AN EQUIVALENT
RECEPTACLE MARKED ‘HOSPITAL
ONLY’ OR ‘HOSPITAL GRADE’
DIOMED 15/30PLUS
- 6 -
3 USING THE ALC SYSTEM
When a fiber equipped with the ALC system is connected to a
DIOMED15/30PLUS, the system will detect the presence of the fiber
and set up a communication link with it. This link is used to determine
what type of fiber is connected, how many more times it may be used
and whether it has passed its sterility expiration date.
The ALC system works with Single-use, Multiple-Use and Spot
Handpiece fibers. It automatically detects the fiber type and, after
checking that it is valid, goes straight to the main menu.
3.1 Single-use Fiber
A typical single-use ALC system fiber will cause the following screen
to be displayed.
Press SELECT and the main menu will be displayed as shown
below.
You may now continue to operate the DIOMED15/30PLUS as
described in the main Operator Manual.
Fiber
Maximum uses remaining
= 1
Press SELECT for Menu
Main Menu
Setup Menu
Presets
Countdown Mode
Session Statistics
Calibration
DIOMED 15/30PLUS
- 7 -
If a previously used single-use fiber is connected to the DIOMED
15/30PLUS, then the following screen will be displayed.
Similarly, if the sterility expiry date of the attached fiber has been
passed, then the following screen will be displayed.
If an invalid fiber is detected by the ALC system then further
operation of the DIOMED15/30PLUS will not be allowed.
Invalid fiber
Accept
Fiber uses expired
Invalid fiber
Accept
Fiber sterility expired
DIOMED 15/30PLUS
- 8 -
3.2 Multiple-use Fiber
When a multiple-use ALC system fiber is connected to a
DIOMED15/30PLUS, the ALC system will check that the fiber has
valid uses remaining and that it has not passed its sterility expiration
date.
A typical multiple-use ALC system fiber with 10 uses remaining will
cause the following screen to be displayed.
Press SELECT and the main menu will be displayed as shown
below.
You may now continue to operate the DIOMED15/30PLUS as
described in the main Operator Manual.
If the fiber is found to have no valid uses remaining or if it has passed
its sterility expiration date then the appropriate Invalid Fiber message
will be displayed, as shown in section 3.1 above
Main Menu
Setup Menu
Presets
Countdown Mode
Session Statistics
Calibration
Fiber
Maximum uses remaining
= 10
Press SELECT for Menu
DIOMED 15/30PLUS
- 9 -
3.3 Spot Handpiece
When a spot handpiece, equipped with an ALC system fiber, is
connected to a DIOMED15/30PLUS, the ALC system will check that
the fiber has valid uses remaining.
Press SELECT and the main menu will be displayed as shown
below. The spot size of the handpiece is automatically detected by
the ALC system and configures the laser accordingly. The spot size
is displayed in the top left corner of the display.
You may now continue to operate the DIOMED15/30PLUS as
described in the main Operator Manual.
If the fiber is found to have no valid uses remaining then the following
screen will be displayed.
2mm Main Menu
Setup Menu
Presets
Fluence
Session Statistics
Calibration
Invalid fiber
Accept
Fiber uses expired
2mm Fiber
Maximum uses remaining
= 50
Press SELECT for Menu
DIOMED 15/30PLUS
- 10 -
4 EMERGENCY OVERRIDE
An Emergency Override option is included to allow the DIOMED
15/30PLUS to be used once only, in the following circumstances:
• The attached fiber is not equipped with the ALC system
• The ALC system fiber is faulty and cannot be identified by the
laser
• A session fault has occurred, preventing the completion of
treatment – see section 4.1 below for a more detailed
explanation of this.
Once the Emergency Override option has been activated, the
DIOMED 15/30PLUS cannot be used in any of the situations listed
above until the option is reset with a special reset device3. See
section 4.2 below for details of the reset operation.
The Emergency Override option cannot be used if the fiber’s sterility
expiry date has been passed or if the fiber is invalid because the
number of “uses” have all been consumed.
When one of the three conditions above is true, the Emergency
Override option will be displayed as shown on the following screen.
Use the ▲ or ▼ keys to select ‘Emergency Override’ and press
SELECT. The DIOMED 15/30PLUS will now show the fiber selection
screen and allow you to proceed with treatment.
3 The unit will continue to operate correctly with ALC system fibers, even if the Emergency Override
option has been activated.
Invalid fiber
Accept
Emergency override
Invalid fiber
DIOMED 15/30PLUS
- 11 -
The next time that an invalid fiber is attached to the DIOMED
15/30PLUS the Emergency Override will not be available and the
following screen will be displayed.
The Emergency Override can only be used again if it is reset by
means of a special reset device. See section 4.2 below for full
details.
4.1 Session Fault Override
In extreme circumstances, such as a power cut or a technical
problem, the DIOMED 15/30PLUS needs to be re-started and will log
a Session Fault. If this occurs during a treatment then the fiber in use
may become invalid.4
In these circumstances, the Emergency Override may be activated to
allow treatment to continue. This option is only available immediately
after the Session Fault has been cleared and will not work if an
attempt is made to use an expired fiber at any other time.
4 WARNING - to avoid accidental invalidation of a single-use ALC fiber:
a. Do not disconnect the fiber from the laser during a procedure unless directed to by the
Operator Manual or the unit’s display.
b. Do not switch off the unit by the key switch or mains switch part way through a procedure.
Invalid fiber
Accept
Invalid fiber
PLEASE SELECT...
Fiber
Spot Handpiece
DIOMED 15/30PLUS
- 12 -
4.2 Resetting the Emergency Override
The Emergency Override can be reset by means of a special reset
device. One of these devices (part number AS/598) is supplied with
the DIOMED 15/30PLUS..
Each device can only be used once, after which is it advisable to
contact your local DIOMED representative as soon as possible, to
obtain a replacement.
To reset the Emergency Override:
• Switch on the laser
• Attach the device by screwing it on to the laser output port, in
the same way as you would attach a fiber
• The unit will detect the device and reset the Emergency
Override. The following screen will be displayed.
Press SELECT and the DIOMED 15/30PLUS will reset the Emergency
Override option and display a notification on the screen.
If a used Emergency Override reset device is attached to the
DIOMED 15/30PLUS then the following screen will be displayed.
Do not attempt to fire the laser when the Emergency Override reset
device is attached.
Emergency override
Reset
Invalid fiber
Accept
Fiber uses expired
DIOMED 15/30PLUS
- 13 -
5 ERROR MESSAGES
The following error messages are additional to those listed in the
DIOMED 15/30PLUS Operator Manual. All error messages will be
displayed on the lower part of the display screen. To clear the error
message, carry out the displayed instructions.
Fiber uses expired All the available uses of the connected fiber have expired. Replace
the fiber with either a new single-use fiber or a multiple-use fiber
that has uses remaining.
Fiber sterility expired DIOMED fibers are programmed at manufacture with a sterility
expiry date. This message is displayed when the expiry date is
before the date in the laser’s internal clock. Replace the fiber with
one having a valid sterility expiry date.
If the error message is still present, check that the clock of the
DIOMED 15/30PLUS is set correctly.
Invalid Fiber The fiber attached to the DIOMED 15/30PLUS is not equipped with
the ALC system. Either replace with an appropriate fiber or use the
Emergency Override option.
6 TROUBLE-SHOOTING
The DIOMED ALC system has been extensively tested. In the
unlikely event of a problem being experienced please perform the
following checks before contacting your local DIOMED
representative for further advice.
“Invalid Fiber” is displayed
even with a new unused
ALC system fiber
(1) Disconnect and then reconnect the fiber to the DIOMED
15/30PLUS. This will cause the unit to try and read the tag again.
(2) Ensure that the DIOMED 15/30PLUS is at least 2 meters away
from any other electrical or electronic equipment that might
interfere with the ALC system, such as computers or other
electronic or medical equipment.
I need to use a non-ALC
system fiber Select the Emergency Override option to allow single use of a non-
ALC system fiber
The Emergency Override
option is not available After it has been used once, the Emergency Override option must be
reset before it can be used again, as described in section 4.2 above.
Contact your local DIOMED representative to obtain a spare reset
device.
The fiber is still within its
sterility date but the laser
shows it as expired
Check that the date of the internal clock in the DIOMED 15/30PLUS
is set correctly.
The procedure for setting the clock is described in the main Operator
Manual.
DIOMED 15/30PLUS
- 14 -
The DIOMED 15/30PLUS
does not recognize ALC
system fibers
Please make sure that you are using a DIOMED 15/30PLUS that is
equipped with the ALC system. Consult your local DIOMED
representative if you require further advice.
7 ORDERING INFORMATION
The following order codes should be quoted when ordering replacement procedure kits and fibers for
your DIOMED 15/30PLUS.
Description DIOMED or fibersdirect.com part number
EVLT Procedure Kit EVLT/PK-20
2mm Spot Handpiece fiber AS/0601
4mm Spot Handpiece fiber AS/0602
This list was correct at the time of publication but new procedure kits, fibers and accessories may be
added at any time. Please check with your local DIOMED representative for the latest information.