IRIDEX 31539 Wireless Footswitch User Manual 692430
IRIDEX Corporation Wireless Footswitch 692430
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Users Manual
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-1
IRIDEX Wireless Footswitch
IRIDEX Wireless Footswitch
Operator Instructions
IRIDEX Laser consoles can be operated with either a wired Footswitch or wireless
Footswitch/Receiver pair. The wireless Receiver or wired Footswitch is connected to the
Footswitch IN jack on the rear of the laser console. The system always tests for a properly
connected wireless Receiver or wired Footswitch in the released state before entering Treat mode.
If you try to select Treat mode when the wireless Receiver or wired Footswitch is damaged or
improperly connected, the Status Display on the console will display the message “Connect
Footswitch.” If you try to enter Treat mode with the Footswitch depressed or depress the
Footswitch while the green Treat light is still flashing on entry to Treat mode, the Status Display
will display the message “Release Footswitch”.
Note: Each Footswitch/receiver pair is uniquely linked and will not work with other
IRIDEX Footswitches or similar components. Make sure to clearly identify each
pair to prevent separation of the linked components. Changes to internal
components may result in increased emissions or decreased immunity.
The wireless device is made up of two parts: a battery powered Footswitch and a console- powered
receiver. The Footswitch has LEDs to assist in trouble shooting and to indicate battery conditions.
The LEDs provide status as follows:
Footswitch LED indicators
Footswitch LED Display Status
Green Flash following pedal depression Footswitch OK, Batteries OK
Amber Flash following pedal depression Footswitch OK, Batteries Low
Blink Red LED for 10 seconds following
footswitch release
No RF Communication
- The console only provides power to the receiver when in “treat” mode.
- When the Footswitch is activated the Footswitch processor initiates a communication link with
the receiver.
- The Footswitch is designed to operate within a minimum of 15 feet of the console.
- Each Footswitch and receiver pair is uniquely linked in order to prevent any other Footswitch
from activating the laser console.
- The Footswitch is designed to maximize battery life. In the unlikely event that the batteries
need to be replaced, please contact your sales representative or IRIDEX Customer Service for
a replacement.
To install, connect the receiver to “Footswitch IN” located on the rear of the laser console.
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-2
IRIDEX Wireless Footswitch
Inspecting and Cleaning the IRIDEX Wireless Footswitch
The IRIDEX Wireless Footswitch ) is submersible (IPX8 IEC529). The wireless receiver is NOT
submersible.
To decontaminate and disinfect the Footswitch:
1. Using water, isopropyl alcohol, or enzymatic detergents with mild pH such as ENZOL, remove
all traces of blood and other body fluids from all exposed surfaces of the Footswitch assembly.
2. Immerse the Footswitch in a CIDEX (2.4% glutaraldehyde) solution to achieve the desired
level of disinfection: a minimum of 45 minutes at 25ºC to achieve a high level of disinfection,
or a minimum of 10 minutes at 20ºC to 25ºC to achieve an intermediate level of disinfection.
3. Remove the Footswitch from the CIDEX solution.
4. Stand the Footswitch on end to drain all fluids.
5. Immerse the Footswitch in a large amount of water for a minimum of 1 minute. Repeat this
step two or more times using clean water for each rinse.
6. Stand the Footswitch on end.
7. Allow the Footswitch to air-dry completely before reusing.
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-3
IRIDEX Wireless Footswitch
Wireless Footswitch Safety Information
Electromagnetic Interference
IRIDEX lasers and accessories (including the Wireless Footswitch) have been tested and found to
comply with the limits for medical devices in IEC 60601-1-2. These limits are designed to
provide reasonable protection against harmful interference in a typical medical installation.
The laser console and accessories generate, use and can radiate radio-frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to other
devices in the vicinity. There is no guarantee that interference will not occur in a particular
installation. If the laser and/or footswitch does cause harmful interference to other devices, which
can be determined by turning the system 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 device.
- Increase the separation between the equipment.
- Connect the laser console into an outlet on a circuit different from that to which the other
device(s) are connected.
- Consult IRIDEX Customer Service for help.
This device 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 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 Class B digital apparatus meets all requirements of the
Canadian Interference-Causing Equipment Regulations.
Cet appareil numérique de la classe B respecte toutes les
exigences du Réglement sur le matériel brouilleur du Canada.
• CAUTION: Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
Note: MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service according to
the EMC information provided in this manual.”
Note: “Portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT.”
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-4
IRIDEX Wireless Footswitch
Note: The frequency range RF transmission is 2.41GHz to 2.46GHz
Note: The frequency range RF transmission is 2.41GHz to 2.46GHz
The system does not utilize spread-spectrum or frequency hopping
modalities. Transmissions are continuous transmissions at discrete
frequencies within the transmission frequency range.
Table 201 per Section 6 of IEC 60601-1-1:2001
Guidance and manufacturer’s declaration – electromagnetic emissions
The EQUIPMENT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EQUIPMENT should assure that it is used in such an
environment.
Emissions Test Compliance
RF emissions
CISPR 11
Group 1
The Wireless Footswitch uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause any
interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class B
Voltage Fluctuations/
Flicker emissions
Complies
The Wireless Footswitch is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-5
IRIDEX Wireless Footswitch
Table 202 per Section 6 of IEC 60601-1-1:2001
Guidance and manufacturer’s declaration – electromagnetic immunity
The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or
the user of the EQUIPMENT should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output
lines
±2 kV for power
supply lines
Not Applicable
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in
UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
EQUIPMENT requires continued
operation during power mains
interruptions, it is recommended that
the EQUIPMENT be powered from
an uninterruptible power supply or a
battery.
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial
or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-6
IRIDEX Wireless Footswitch
Table 204 per Section 6 of IEC 60601-1-1:2001
Guidance and manufacturer’s declaration – electromagnetic immunity
The Wireless Footswitch is intended for use in the electromagnetic environment specified below. The
customer or the user of the Wireless Footswitch should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
EQUIPMENT, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = [3.5/V1]√P
d = [3.5/E1]√P 80 MHz to 800 MHz
d = [7/E1]√P 800 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should be
less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
EQUIPMENT is used exceeds the applicable RF compliance level above, the EQUIPMENT should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the EQUIPMENT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 1-7
IRIDEX Wireless Footswitch
Table 206 per Section 6 of IEC 60601-1-1:2001
Recommended separation distances between
portable and mobile RF communications equipment and the EQUIPMENT
The Wireless Footswitch is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Wireless Footswitch can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Wireless Footswitch as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power
of transmitter
W
150 kHz to 80 MHz
d = [3.5/V1]√P
80 MHz to 800 MHz
d = [3.5/E1]√P
800 MHz to 2.5 GHz
d = [7/E1]√P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.39
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Premarket Notification, 510(k) Submission for: Section 13: Proposed Labeling – Page 8
IRIDEX Wireless Footswitch
Section 1 – Cleaning, Sterilization, and Shelf Life
14.1 Cleaning
Inspecting and Cleaning the IRIDEX Wireless Footswitch
The IRIDEX Wireless Footswitch ) is submersible (IPX8 IEC529). The wireless
receiver is NOT submersible.
To decontaminate and disinfect the Footswitch:
1. Using water, isopropyl alcohol, or enzymatic detergents with mild pH such as
ENZOL, remove all traces of blood and other body fluids from all exposed
surfaces of the Footswitch assembly.
2. Immerse the Footswitch in a CIDEX (2.4% glutaraldehyde) solution to
achieve the desired level of disinfection: a minimum of 45 minutes at 25ºC to
achieve a high level of disinfection, or a minimum of 10 minutes at 20ºC to
25ºC to achieve an intermediate level of disinfection.
3. Remove the Footswitch from the CIDEX solution.
4. Stand the Footswitch on end to drain all fluids.
5. Immerse the Footswitch in a large amount of water for a minimum of 1
minute. Repeat this step two or more times using clean water for each rinse.
6. Stand the Footswitch on end.
7. Allow the Footswitch to air-dry completely before reusing.
14.2 Sterilization – Not Applicable
The IRIDEX Wireless Footswitch is not a sterile device.
14.3 Shelf-Life – Not Applicable
The IRIDEX Wireless Footswitch does contain any age dated materials.