Boston Scientific EXALT Controller User manual

50866131-01 Rev. A
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
INTRODUCTION
This user manual describes how to appropriately and safely
use, maintain, and troubleshoot the EXALT Controller (hereafter
called the Controller).
The Controller is used with a Boston Scientific single-use
endoscope. Refer to “EXALT Controller Compatibility” for
compatible Boston Scientific single-use endoscopes.
Where to Get Help
For technical support, ordering, service, and return
authorization, contact BostonScientific at 800-949-6708.
DEVICE DESCRIPTION
The Controller is an electronic device that:
• Receives video signals from a Boston Scientific single-use
endoscope,
• Processes the video signals,
• Outputs video images to a video monitor, and
• Outputs electrical signal(s) that interface with external
image capture systems.
The Controller also controls the light transmitted by the tip of
the single-use endoscope to illuminate the area of interest
within the anatomy. Buttons on the Controller’s front panel
enable the user to control the brightness level of the light.
To use the Controller, connect it to a video monitor with a
video cable and then connect a Boston Scientific single-use
endoscope to the Controller. The Controller provides direct
visualization during an endoscopic procedure.
The Controller interfaces with external media capture equipment
via the Controller’s rear panel connectors. Image capture
is initiated via a button on the Boston Scientific single-use
endoscope. The Controller sends a signal to the video monitor
notifying the user that an image capture has been initiated.
User Information
The Controller and these instructions are intended for use by
physicians trained in endoscopic procedures.
A thorough understanding of the techniques, principles,
clinical applications and risks associated with endoscopic
procedures is required before using the Controller with the
single-use endoscope.
Contents
• One (1) EXALT Controller
• For M00542430 – One (1) North American Power Cable
• For M00542460 – One (1) EU Power Cable & One (1) Brazil
Power Cable
• One (1) 2.0-meter DVI cable
• One (1) 2.0-meter HDMI cable
Ensure the package contains the components listed above.
Model Numbers
EXALT Controller M00542430
EXALT Controller (Alt-Language) M00542460
Specifications
Electrical Specifications
Input voltage 100 to 240 VAC, 50/60 Hz
Rated current 1A-0.5A
Fuse rating 250 V, 2A, Type F (F2AH250V)
Power Cord Specifications
115 VAC
Domestic (US)
Length—3.1 meters (10 feet)
Voltage Rating—125 VAC
Current Rating—10 amps
Connector Type—IEC 60320 C13
250 VAC
International:
Length—2.5 meters (8.2 feet)
Voltage Rating—250 VAC
Current Rating—10 amps
Connector Type—IEC 60320 C13
Physical Specifications
Height 11.5 cm (4.5 in)
Width 33.0 cm (13.0 in)
Depth 39.5 cm (15.5 in)
Weight (unpackaged) 6.4 kg (14 lb)
INTENDED USE/INDICATIONS FOR USE
The EXALT™ Controller is intended for use with a Boston Scientific
single-use endoscope for endoscopic diagnosis, treatment, and
video observation.
CONTRAINDICATIONS
None known.
WARNINGS
• Read this user manual, the single-use endoscope directions for
use, the monitor user manual, and any external media capture
device user manuals before using the Controller. Failure to
follow any instructions or failure to heed any warnings or
precautions may result in harm or injury to patient.
• Do not use the Controller in the presence of flammable fluids
and gases such as alcohol or oxygen. Doing so can result in fire
and burns to the operator and patient.
• Do not perform diagnostic or therapeutic procedures without
a clear and adequate video display. Doing so can result in
adverse events.
• Placing the Controller where other electrical medical devices
can degrade the video image can delay the procedure and
result in adverse events. In addition, placing the Controller
where it can degrade the performance of other equipment
in the endoscopy suite due to EMI emissions can delay the
procedure or result in adverse events. To ensure the Controller
displays a clear and adequate video image and does not
degrade the performance of other equipment, locate the
Controller as described in Table 6, Table 7, Table 8, and Table
9 in the Appendices. Verify operation in the endoscopy suite
environment before starting a procedure. Follow ancillary
equipment directions for use to locate ancillary equipment.
• Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they
are operating normally.
• Using a Controller without cleaning the cabinet and front panel
buttons can expose the operator to biohazardous materials. To
prevent exposure to biohazardous materials, clean the cabinet
between uses, following the procedure described in “Cleaning.”
• If the Controller is connected to an improperly grounded power
supply, electrical leakage can result in electrical shock to the
user. To avoid risk of electrical shock, this equipment must only
be connected to a supply mains with protective earth.
• Do not touch connecting devices for electrical connections
between the different components (such as signal input and
output connections for video signals, data exchange, control
circuits, etc.) and the patient at the same time. Doing so can
result in electric shock to the patient.
• If the Controller experiences an unintended shutdown or lock up
during a procedure, follow the procedure described in “Recovering
from a Controller Failure.” Failure to follow this recovery procedure
after a Controller failure can result in patient injury.
• No modification of this equipment is allowed.
• The use of accessories and cables other than those specified
or supplied as spare parts from Boston Scientific may result
in increased emissions or decreased immunity of the
Controller or single-use endoscope.
• Components connected to the EXALT™ Controller by the
user must be certified to the respective IEC standards
(IEC 60601-1 for medical equipment, IEC 60950 for data
processing equipment, and IEC 60065 for A/V equipment).
In addition, the user must ensure the new configuration
complies with the IEC 60601-1 standard.
• Portable radio frequency (RF) communications equipment
(including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to
the Controller, single-use endoscope, or ancillary equipment,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
• The emissions characteristics of this equipment make it suitable
for use in industrial areas and hospitals (CISPR 11 class A). If it
is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The
user might need to take mitigation measures, such as relocating
or re-orienting the equipment.
• Do not connect the output of any equipment to the
Controller’s video outputs.
• For hospital use only.
PRECAUTIONS
• Blocking the Controller’s ventilation outlet can cause the
Controller to overheat, resulting in a thermal shutdown or
equipment damage. Leave at least 12.7 mm (0.5 in) between
the Controller back panel and other objects and 12.7 mm
(0.5 in) of space between the side panels and other objects.
The Controller may be used on a dedicated equipment cart
to ensure proper ventilation.
• Spilling liquids on the Controller can damage it or cause it to
shut down. Do not place liquids above or near the Controller.
• Opening the cabinet for repair purposes can damage
the Controller. The Controller does not use operator-
serviceable components. To prevent damage, do not
access the Controller cabinet.
• Connecting an incompatible single-use endoscope to
the Controller can damage the Controller. Only connect
a single-use endoscope listed in the “EXALT Controller
Compatibility” section.
• Locate the Controller appropriately to avoid accidentally
pulling cable connections, which can result in
disconnection and loss of visualization.
• Before starting a procedure, ensure components such as the
monitor and irrigation pump that support the EXALT Controller
and single-use endoscope are present and operational.
Starting a procedure without the supporting components
present and operational can prolong the procedure.
• Do not use cleaning solutions that contain long-life
surfactants. Doing so can leave conductive residues
on the contacts of the single-use endoscope connector
receptacle. The conductive residues can lead to
malfunctions of the Controller.
• Use of a cardiac defibrillator while a connected single-
use endoscope remains in a patient can damage the
Controller. To prevent damage to the Controller when using
a defibrillator, remove the single-use endoscope before
using the defibrillator.
• Do not insert a wet connector into the Controller
receptacle as poor video performance or damage to the
Controller may result.
• Applied parts of other electrical medical equipment in
application with this equipment have to be type BF. Hence,
only connect a single-use endoscope listed in the “EXALT
Controller Compatibility” section.
ADVERSE EVENTS
Please refer to single-use endoscope DFU.
CONFORMANCE TO STANDARDS
Essential Performance Statement
Per IEC 60601-1, the Controller does not have any functions that
would present an unacceptable risk if failure occurred.
HOW SUPPLIED
Device supplied non-sterile. Inspect the Controller and cables
for damage. Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible. Do not use a
component if it appears damaged.
EXALT™Controller
User’s Manual
2019-12
<en >

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
Handling and Storage
Environmental Limits During Transportation, Use, and Storage
Table 1. Transportation, use, and storage environmental limits
Environmental Limits during Use
Ambient temperature (°C) 10 to 35
Relative humidity (%) 30 to 85 (non-condensing)
Atmospheric pressure (hPa) 700 to 1060
Environmental Limits during Transport and Storage
Ambient temperature (°C) -40 to 70
Relative humidity (%) 10 to 90 (non-condensing)
Atmospheric pressure (hPa) 500 to 1060
EXALT™ CONTROLLER COMPATIBILITY
All attached equipment must comply with its applicable IEC
standards.
The Controller is compatible with:
• EXALT Model D Single-use Duodenoscope (M00542420 and
M00542421).
• Medical grade video monitors with standard video signal
inputs (at a minimum: DVI 1.0 and/or HDMI 1.0). Controller
incorporates standard video signal outputs (i.e. DVI 1.0, HDMI
1.0) to allow connection to a monitor. Controller was tested
for compatibility with the NDS Radiance G3 26” medical grade
monitor at the following factory default settings:
Input: DVI – 1920 x 1080p @ 60.00Hz
Parameter Setting
Brightness 50
Contrast 50
Sharpness 0
Overscan 0
Gamma 2.2
Color Temperature Default
Red 50
Green 45
Blue 46
Saturation 50
Hue 50
Video Level Normal
Color Correction Bypass
Backlight Control Off
• External media capture devices that have a 9-pin RS-232
compliant DB9 signal input connector and/or a TRS jack
with a maximum rating of 5 VDC. Controller was tested
for compatibility with media capture devices listed in the
following table. Call Boston Scientific for system specific
setup instructions.
Image Capture Device Software Version
Medicapture USB-300 170510
TEAC®UR-4MD a1.15
ProVation®MD by ProVation®Medical 5.0.410.23
gMED gGastro™v4.67
ENDOBASE™by Olympus®13.0.
SETUP AND OPERATION
Front Panel Features
Figure 1, Table 2, and Table 3 illustrate and describe the
Controller’s front panel features.
Figure 1. Illustration of front panel features
1 2 3 4 5 6
Table 2. Description of front panel features
Feature Description
1
Power Button—When the
Controller is connected to
a power source, pushing
the power button alternates
between powering up and
powering down the Controller.
The power button illuminates
green when the Controller is
powered up.
2
Connection Cable Receptacle—
User plugs the umbilicus cable
from the single-use endoscope
into the receptacle during setup.
3Indicates user must use BF
applied parts.
4
Light On/Off Button—Pressing
this button alternately turns
the light off and on. When the
Controller is on, each press of
the Light On/Off button toggles
the light between on and off.
When the light is on, the button
illuminates blue. When the light is
off, the button illuminates white.
5
Brightness Control Buttons—
When the light is on, the
brightness control buttons
are illuminated blue. Pressing
the button increases the
intensity of the light. Pressing
the button decreases the
intensity of the light.
6
Brightness Indicator—The
bars of this indicator illuminate
to indicate the brightness of
the light. There are five levels
of brightness (Table 3).
Table 3. Interpreting the brightness indicator
Illumination State of
Brightness Indicator Setting Description
Low
Med-Low
Med
Med-High
High
Rear Panel Features
Figure 2 and Table 4 illustrate and describe the Controller’s rear
panel features.
Figure 2. Illustration of back panel features
1 2 3 4 5 6 7 8 9 10 11
12
Table 4. Description of back panel features
Feature Description
1
USB port access cover
(tool required)—For
Boston Scientific Service
Personnel only. User shall
not remove the access
cover or plug any ancillary
devices into the USB port.
2
Two DVI Output
Connectors—Video
output connector for
compatible DVI-1.0
capable monitors.
3Video Output—Symbol
indicating video outputs.
4
HDMI Output Connector—
Video output connector
for compatible HDMI-1.0
capable monitors.
5
Remote Control Lead—
Symbol indicating remote
control lead.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
Feature Description
6
RS232 DB9 Connector—
Image capture output
connector for connection
with external media
capture devices. [A user-
supplied RS-232 DB9
Straight Through cable is
required to connect the
EXALT™ Controller to an
external media capture
device. To configure system
for connection call Boston
Scientific for support.]
7
3.5mm TRS Connector
Jack—Image capture
output connector for
connection with external
media capture devices.
To configure system for
connection call Boston
Scientific for support.
8
Cabinet Ventilation
Outlet—The cabinet
ventilation outlet enables
the cooling fan to exhaust
hot air from the cabinet
to maintain the proper
operating temperature
inside the cabinet.
9
Potential Equalization
Conductor—Symbol for
potential equalization
conductor.
10
Potential Equalization
Conductor—Provides a
means of securely linking
the potential equalization
conductor of the
Controller to ground.
11
Fuse Holder Module and
Power Cord Connector—
The fuse holder module
provides access to the
Controller electrical
fuses. The power cord
connector accepts the AC
power cord that connects
to an AC Main. Removal of
the detachable cord from
the appliance inlet is the
means by which AC main
is disconnected from the
device.
12
Label—Provides
regulatory and
manufacturing information.
Patient Environment
The Controller is patient equipment and can be used in the
patient environment (Figure 3).
Place the Controller to allow easy access to the power cord in
the event user must quickly disconnect the Controller from the
main power source.
Figure 3. Typical positioning of equipment, patient, and operator
R = 1.5 m
H = 2.5 m
Note about Performance
To ensure the Controller performs within its design specifications,
position it following the guidelines presented in the Appendices.
Isolating the Controller from the Main Power Supply
To isolate the Controller from the main power supply, disconnect the
power cord from the power supply receptacle or from the power
cord receptacle on the Controller.
Software
The revision level of the software installed on the Controller is
displayed on the cable connect screen.
Setup of the Controller
All attached equipment must comply with its applicable IEC standards.
Upon receiving the Controller, complete these initial setup steps:
1. Inspect the Controller and its components to ensure they
are not damaged.
2. Clean the Controller following the instructions in the
“Cleaning” section.
3. Place the Controller and Video monitor on a stable, level
surface, such as an equipment cart, in the procedure room.
See the “EXALT™ Controller Compatibility” section for
additional information if needed.
4. Use the DVI or HDMI cable, supplied by Boston Scientific, to
connect one of the video input connectors on the video monitor
to one of the video output connectors on the Controller.
5. Connect the Controller and video monitor power cords to
electrical receptacles.
6. If required: Connect to external media capture devices
following the steps in the respective device’s Directions for
Use. Contact Boston Scientific for specific setup instructions.
7. Power on and set the monitor video input based on the
cable selected in Step 4.
8. Power on the Controller using the steps in the “Starting the
Controller” section
Note: Controller must be powered on in order to configure
monitor, however a single-use endoscope does not
need to be connected.
9. Configure the monitor for use in DVI or HDMI mode following
the steps in the respective monitor’s directions for use.
Note: Monitor must be configured before beginning a procedure.
Contact Boston Scientific for specific setup instructions.
Starting the Controller
Follow the steps below to start the Controller. User can start the
Controller with or without the single-use endoscope umbilicus
cable plugged into the Controller.
Powering On the Controller
1. Press the power button to start the Controller. The power
button will illuminate green, and the Controller will begin
a self-test and boot sequence. The monitor displays the
boot screen (a) followed by the transition screen (b). If
monitor does not display the boot screen, consult the
troubleshooting section.
(a) Boot screen
(b) Transition screen
ab
2. Upon a successful boot up, the monitor displays the cable
connect screen (c) showing the software version (d).
Connect the single-use endoscope connection cable to the
Controller until it locks into place. Pull back on the cable
connector to ensure the connector is fully seated in the
Controller. If a single-use endoscope is already connected,
this screen will not appear, proceed to step 3.
Note: To remove the Boston Scientific watermark (e) from the
screen, simultaneously press the and buttons for at least
3 seconds while the cable connect screen is displayed on the
monitor. To redisplay the watermark, press the and buttons
for at least 3 seconds.
(c) Cable connect screen
(d) Software version—Note: version
on monitor may be different than
this image
(e) BostonScientific watermark
c
d
e
3. The Controller briefly displays the single-use endoscope
loading screen (f).
(f) single-use endoscope
loading screen
f
4. Shortly after the single-use endoscope loading screen
appears, a live video image will appear on the live video
screen (g). If the live image does not appear, consult the
troubleshooting section.
g
(g) Live video screen with example image
5. If a live image is lost during a procedure as a result of
damage to the single-use endoscope, the Controller
will display the Scope Error Screen (h). If the single-
use endoscope is damaged, replace the single-use
endoscope.
h
(h) Scope Error Screen
Adjusting the Brightness of the Video Image and Operating
Light ON/OFF button
To increase the brightness of the video image as displayed
on the live video screen, press the button. To decrease
the brightness of the video image, press the button. The
image brightness scale provides visual feedback of the relative
brightness of the light source.
Pressing the light On/Off button toggles the light source
between ON and OFF state. To operate the light On/Off
button the Controller must be powered on and an single-
use endoscope must be connected to the Controller. Button
illuminates white when the light is off and blue when it is on.
1
2
3
4
1. Increases image brightness (brightness control button)
2. Image brightness scale
3. Decreases image brightness (brightness control button)
4. Light ON/OFF button
Note: White balance is adjusted automatically by the system
and no user adjustment is required.
Recovering from a Controller Failure
There are two possible failure modes: (1) unintended Controller
shutdown, and (2) Controller that becomes unresponsive.
Recovery from Unintended Shutdown
Follow these steps to recover from an unintended Controller
shutdown:
1. Press the Controller’s Power button to restart the Controller.
2. If the Controller fails to start, contact Boston Scientific.
3. If the Controller starts and subsequently shuts down,
remove any accessory from the single-use endoscope,
and remove the single-use endoscope from the patient.
Restart the Controller and plug in a new scope if available.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
Recovery from a Controller that Becomes Unresponsive
Follow these steps to recover from a Controller that becomes unresponsive:
1. Unplug the single-use endoscope from the Controller and plug the single-use endoscope
back in to the Controller.
2. If this does not resolve the issue, press the Controller’s Power button to power off the Controller.
3. Press the Controller’s Power button to restart the Controller.
4. If the Controller fails to start, contact Boston Scientific.
5 If the situation cannot be resolved, remove any accessory from the single-use endoscope,
and remove the single-use endoscope from the patient.
Considerations When Using a Laser, HF or EHL Device
When activating energy from a high frequency (HF) generator, laser or electrohydraulic lithotripsy
(EHL) generator during lithotripsy, a bright flash on the video monitor and possibly a momentary
disruption in the video quality may occur. This reaction is normal and is not indicative of a defect or
operating problem with the Controller or single-use endoscope.
COMPLETING A PROCEDURE
The procedure below describes the procedural use of the Controller and is to be performed only
once the user has received, inspected, assembled, and tested the Controller following instructions
in the “Setup and Operation” section.
Using the Controller In an Endoscopy Procedure
Using the Controller includes the following steps:
1. Clean the Controller as directed in the “Cleaning” section.
2. Power up the Controller.
3. Configure the monitor.
4. Connect a single-use endoscope to the front panel connector.
5. Complete the procedure as outlined in the single-use endoscope directions for use.
Shutting Down the Controller
To shut down the Controller at the end of a procedure or during a procedure, follow these steps:
1. Remove any accessory and the single-use endoscope from the patient following the
instructions in the single-use endoscope directions for use.
2. Disconnect the single-use endoscope cable from the front of the Controller by pushing down on
the umbilicus cable connector locking tab and pulling it out of the receptacle.
3. Power down the Controller by pressing the Power button. The power button indicator light
shuts off indicating power has been cut to the Controller.
4. If the Controller is being shut down after finishing a procedure, dispose of the single-use
endoscope as described in the single-use endoscope directions for use. Then clean the
Controller as directed in the “Cleaning” section.
Routine Inspection and Maintenance
The Controller does not require routine maintenance and calibration because the self-test mode,
activated automatically upon turning on the power to the Controller, verifies correct functionality
of the Controller. Periodically check the power cord assembly for damage to the insulation or
connectors. In the event that the Controller requires repair or replacement, contact Boston Scientific.
Cleaning
Disconnect the power cord before cleaning the unit. Use a 15 to 70 percent isopropyl alcohol in
purified water solution and a cloth to clean the Controller enclosure, front panel, video cables,
and power cable. Do not allow fluids to enter the enclosure, power cable connections, single-use
endoscope cable receptacle, or component/accessory connections. Do not attempt to clean the
unit while it is plugged into an electrical outlet.
Disposal of the Product, Accessories, and Packing Materials
For disposal, observe relevant country regulations and laws.
Note for users in California, USA. Perchlorate Material—special handling may apply. Battery in
Controller contains Perchlorate.
See www.dtsc.ca.gov/hazardouswaste/perchlorate.
For further information, contact Boston Scientific.
TROUBLESHOOTING AND RESPONDING TO ERROR CODES
Troubleshooting Chart
Most operating problems are easily resolved. If the Controller does not operate as expected, try
to resolve the problem with this troubleshooting chart before contacting Boston Scientific for
technical support (Table 5).
Table 5. Controller troubleshooting chart
Symptom Possible Cause Corrective Action
Controller does not start or
power button is not illuminated
green when pressed
Power cord not
connected or not
connected tightly
Ensure both ends of the power
cord are firmly connected to
their connection points.
No electrical power at
the receptacle
Check the receptacle’s circuit
breaker to ensure it is not tripped.
Confirm the receptacle has power
by operating another electrical
device from the receptacle.
Boot problem
Reboot the Controller by
powering it down and restarting
it. If the problem reoccurs, call
Boston Scientific for support.
Defective power cord Replace power cord.
Controller fuse blown Call BostonScientific for support.
Controller damaged Call BostonScientific for support.
Single-use endoscope
umbilicus cable is plugged
into the Controller, but no
video image is displayed.
Video monitor is not
powered up or not
connected
Power up the video monitor.
Check that the video cable
is properly connected to the
monitor and Controller. Verify
that the monitor is set to the
correct video input.
Single-use endoscope
umbilicus cable is not
properly connected to
Controller
Ensure the plug on the single-
use endoscope umbilicus
cable is firmly inserted into the
connector with the locking tab
facing up. Ensure connection
terminals are dry and clean.
Single-use endoscope is
broken or defective Replace single-use endoscope.
Illumination light is off
Press illumination light button
to turn on light. (The light On/Off
button should be illuminated blue).
Single-use endoscope
connection cable is plugged
into the Controller, but cable
connection screen is displayed.
Single-use endoscope
cable is not properly
connected to Controller
Ensure the plug on the single-
use endoscope umbilicus
cable is firmly inserted into the
connector with the locking tab
facing up. Ensure connection
terminals are dry and clean.
Single-use endoscope is
broken or defective Replace single-use endoscope.
Single-use endoscope
experiences image loss and the
scope error screen is displayed.
Single-use endoscope is
broken or defective Replace single-use endoscope.
Video image is too dark.
Brightness setting is
too low
Adjust brightness using
brightness control buttons.
Debris covering the distal
tip of the single-use
endoscope
Clean the distal tip by irrigating
it with a purified water solution
using a cotton swab.
Single-use endoscope
illumination elements
are damaged
Replace single-use endoscope.
Video image is too bright
Brightness setting is
too high
Adjust brightness using
brightness control buttons.
Video cable connected to
monitor output
Ensure video cable is
connected into monitor video
input and not output.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
APPENDICES
The appendices include:
• Appendix 1—Guidance and Manufacturer’s Declaration-Electromagnetic Emissions
• Appendix 2—Guidance and Manufacturer’s Declaration-Electromagnetic Immunity
• Appendix 3—Guidance and Manufacturer’s Declaration— electromagnetic IMMUNITY – for
ME Equipment and ME Systems that are not LIFE-SUPPORTING
• Appendix 4—Recommended Separation Distance Between Portable and Mobile RF
Communications Equipment and the EXALT™ Controller
• Appendix 5—Medical Design Criteria and Specifications
The Controller and Duodenoscope were tested for compliance to IEC 60601-1. An Olympus OEV262H
was used during this testing as support equipment. Any additions or modifications to the Controller,
Duodenoscope, or previously configured accessories require the end user to ensure the system
remains compliant with the requirements of IEC 60601-1.
Appendix 1—Guidance and Manufacturer’s Declaration-Electromagnetic Emissions
The EXALT Controller is intended for use in the electromagnetic environment specified below (Table 6).
The customer or the user of the EXALT Controller should assure that it is used in such an environment.
Table 6. Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions Test Compliance Electromagnetic Environment—Guidance
RF Emissions
CISPR 11 Group 1
The EXALT Controller 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 A The EXALT Controller is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2 Class A
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Per section 5 of
IEC 61000-3-3
Appendix 2—Guidance and Manufacturer’s Declaration-Electromagnetic Immunity
The EXALT Controller is intended for use in the electromagnetic environment specified below (Table 7).
The customer or the user of the EXALT Controller should assure that it is used in such an environment.
Table 7. Guidance and manufacturer’s declaration—electromagnetic immunity IEC 60601-1-2
(2nd edition and 3rd edition)
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
(Guidance)
Electrostatic
discharge
(ESD) IEC
61000-4-2
± 6 kV contact
± 8 k/V air
± 6 kV contact
± 8 k/V 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
± 1 kV for input/
output lines
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% U
(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% U
(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
EXALT™ Controller requires continued
operation during power mains
interruptions, it is recommended that
the EXALT Controller be powered from
an uninterruptible power supply or
a battery.
Power
frequency
(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.
Symptom Possible Cause Corrective Action
Video image is blurry, scrambled,
inadequate, distorted, or
otherwise not acceptable
Controller is too close to
other electrical medical
equipment
Ensure Controller is placed as
directed in Table 9 or Table 10 of
Appendix 4.
Shutdown other medical
electrical equipment to
determine which equipment is
causing the symptom. Properly
place other electrical medical
devices according to their
directions for use.
Video cable not completely
connected to either
monitor or Controller
Ensure video cable is
completely connected to video
monitor and Controller.
Video cable connected to
monitor output
Ensure video cable is
connected into monitor video
input and not output.
Debris covering the distal
tip of the single-use
endoscope
Clean the distal tip by irrigating
it with a purified water solution
using a cotton swab.
Video monitor is not
compatible with Controller
Replace monitor with
compatible monitor.
Cabinet is warm-to-hot to the
touch
Cabinet ventilation outlet
is blocked with debris or
too close to other objects
Reposition Controller to provide
more clearance for ventilation.
If not resolved, contact Boston
Scientific for support.
Image Capture does not
transfer to external media
capture device.
Video and Image Capture
Trigger cables not
connected to external
image capture device or
controller
Ensure trigger and video cables
are completely connected to
controller and external device.
Call Third party image capture
manufacturer.
If any of these problems persist, please contact Boston Scientific for repair or replacement
information.
WARRANTY
Limited Warranty
Boston Scientific Corporation (BSC) warrants for one year from the date of purchase that reasonable care
has been used in the design and manufacture of this product. This warranty is in lieu of and excludes
all other warranties not expressly set forth herein, whether expressed or implied by operation of law or
otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular
purpose. Handling, cleaning and storage of the product as well as other factors relating to the patient,
diagnosis, treatment, surgical procedures, and other matters beyond Boston Scientific Corporation’s
control may directly affect the product and results obtained from it. Boston Scientific Corporation shall
repair or replace, at its option, any part of the product that Boston Scientific Corporation determines was
defective at time of shipment if notice thereof is received within one year of shipment. Boston Scientific
Corporation shall not be liable for any incidental or consequential loss, damage, or expense directly or
indirectly arising from the use of the product. Boston Scientific Corporation neither assumes, nor authorizes
any other person to assume for it, any other or additional liability or responsibility in connection with the
product. BSC assumes no liability with respect to product use by a non-qualified physician; use contrary to
documentation; use with a non-Boston Scientific single-use endoscope. Buyer shall be responsible for the
ongoing support and maintenance of the product not covered by this one year warranty and after the one
year warranty period has expired. Buyer may, at its sole cost and expense, purchase an extended warranty
from Boston Scientific Corporation (BSC) to extend the term of this warranty.
Obtaining Warranty Service from BostonScientific Corporation
Contact Boston Scientific technical support at 800-949-6708 to report a problem with the Controller
and obtain a return authorization number, if required.
Return the Controller to Boston Scientific Corporation. All shipments to Boston Scientific Corporation
must be insured and safely and securely packaged, preferably in the original shipping carton, and should
include a letter explaining the problem and making reference to the return authorization number.
All transportation and insurance charges and risk of loss are the responsibility of the customer and
must be prepaid. A purchase order must be issued to Boston Scientific Corporation to cover all
transportation and insurance charges for return shipment after service.
A return goods authorization (RGA) tracking number for the returning product will be provided.
Include the RGA number on the outside of the return packaging.
gGastro is a trademark of Modernizing Medicine Gastroenterology, Inc
ENDOBASE is a trademark of Olympus Corporation.
PROVATION is a trademark of Provation Medical Inc.
TEAC is a trademark of TEAC Corporation

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
Immunity Test IEC 60601
Test Level Compliance Level Electromagnetic Environment (Guidance)
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Portable and mobile RF communications
equipment should be used no
closer to any part of the EXALT
Controller, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d=1.2√P
d=1.2√P
80 MHz to 800 MHz
d=2.3√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 meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should be
less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity
of equipment marked with the following
Symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
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 EXALT Controller is used exceeds the applicable RF
compliance level above, the EXALT Controller should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the EXALT Controller.
b) Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
Appendix 3—Guidance and Manufacturer’s Declaration— electromagnetic IMMUNITY – for ME
Equipment and ME Systems that are not LIFE-SUPPORTING
The EXALT™ Controller is intended for use in the electromagnetic environment specified below (Table 8).
The customer or the user of the EXALT Controller should assure that it is used in such an environment.
Table 8. Guidance and manufacturer’s declaration—electromagnetic immunity IEC 60601-1-2
(4th edition)
Immunity Test IEC 60601
Test Level/ Compliance Level
Electromagnetic Environment
(Guidance)
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 k/V 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
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
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips
IEC 61000-4-11
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270°, and 315°
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the EXALT
Controller requires continued operation
during power mains interruptions, it is
recommended that the EXALT Controller
be powered from an uninterruptible
power supply or a battery.
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0°
Voltage
interruptions
IEC 61000-4-11
0% UT; 250/300 cycle
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the EXALT
Controller requires continued operation
during power mains interruptions, it is
recommended that the EXALT Controller
be powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
30 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.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
Immunity Test IEC 60601
Test Level/ Compliance Level
Electromagnetic
Environment
(Guidance)
Conducted RF
IEC 61000-4-6
3 V
0.15 MHz -80 MHz
6 V in ISM bands between
0.15 MHz -80 MHz
80% AM at 1 kHz
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the EXALT ™
Controller, including
cables, than the
recommended
separation distance
calculated from the
equation applicable
to the frequency of
the transmitter.
Recommended
separation distance
d=2√P
80 MHz to
2.7 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 meters (m).
Field strengths from
fixed RF transmitters,
as determined by
an electromagnetic
site surveya, should
be less than the
compliance level
in each frequency
rangeb.
Interference may
occur in the vicinity
of equipment marked
with the following
Symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
Test
Frequency
(MHz)
Band
(MHz) Modulation
Immunity
Test Level
(V/m)
385 380 - 390
Pulse
modulation
18 Hz
27
450 430 - 470
FM
± 5 kHz
deviation
1 kHz sine
28
710
704 - 787
Pulse
modulation
217 Hz
9745
780
810
800 - 960
Pulse
modulation
18 Hz
28870
930
1720
1700 - 1990
Pulse
modulation
217 Hz
281845
1970
2450 2400 - 2570
Pulse
modulation
217 Hz
28
5240
5100 - 5800
Pulse
modulation
217 Hz
9
5500
5785
Note —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 EXALT Controller is used
exceeds the applicable RF compliance level above, the EXALT Controller should be observed
to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the EXALT Controller.
b) Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
Appendix 4—Recommended Separation Distance Between Portable and Mobile RF
Communications Equipment and the EXALT™ Controller
The EXALT Controller is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the EXALT Controller can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the EXALT Controller as recommended below,
according to the maximum output power of the communications equipment (Table 9 or Table 10).
Table 9. Recommended separation distances between portable and mobile RF communications
equipment and the EXALT Controller IEC 60601-1-2 (2nd edition and 3rd edition)
Max Output Power
(Watts)
Separation (m)
150 kHz to 80 MHz
D=1.2(Sqrt P)
Separation (m)
80 MHz to 800 MHz
D=1.2(Sqrt P)
Separation (m)
800 MHz to 2.5 GHz
D=2.3(Sqrt P)
0.01 .12 .12 .23
0.1 .38 .38 .73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
(d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
P is the maximum output power of the transmitter in watts (W) according to the 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.
Table 10. Recommended separation distances between portable and mobile RF communications
equipment and the EXALT Controller IEC 60601-1-2 (4th edition)
Max Output Power (Watts) Separation Distance D=2√P
0.01 0.2
0.1 0.6
1 2.0
10 6.3
100 20.0
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power of the transmitter in watts (W) according to the
manufacturer.
NOTE —These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
Appendix 5—Medical Design Criteria and Specifications
The EXALT Controller meets medical design criteria and specifications (Table 11):
Table 11. Medical design criteria and specification
Design Criteria for EXALT Controller Specification
Type of protection against electric shock Class 1 equipment
Degree of protection against electric shock Type BF applied part
Mode of operation Continuous operation
Installation and use Portable equipment

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A) eDFU, MB, EXALT Controller, EN, 50866131-01 Rev. A
Black (K) ∆E ≤5.0
Catalog Number
REF
EU Authorized Representative
EC REP
Consult instructions for use.
Contents
Legal Manufacturer
Australian Sponsor Address
AUS
Do not use if package is damaged.
EU Authorized
Representative
Boston Scientific Limited
Ballybrit Business Park
Galway
IRELAND
EC REP
Legal
Manufacturer
Manufactured for:
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 800-949-6708
© 2019 Boston Scientific Corporation or its affiliates.
All rights reserved.
Australian
Sponsor Address
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone [phone]
Free Fax [phone]
AUS
Do not use if package
is damaged.
Argentina
Local Contact
ARG
Para obtener información de
contacto de Boston Scientific
Argentina SA, por favor, acceda al
link www.bostonscientific.com/arg
Argentina Local Contact
ARG
Brazil Local Contact
BRA
Brazil
Local Contact
BRA
Para informações de contato da
Boston Scientific do Brasil Ltda,
por favor, acesse o link
www.bostonscientific.com/bra
CAUTION. Attention: Consult
ACCOMPANYING DOCUMENTS.
Date of Manufacture
Recyclable Package
Fuse
Separate Collection
Serial Number
SN
Humidity limitation.
Temperature limitation.
Type BF Applied Part
Non-Ionizing Electromagnetic Radiation
cTUVus Mark indicates compliance to UL
60601-1 and CAN/CSA 22.2 601.1 M90
covering electrical safety requirements
for the US and Canada.
C US
TÜV Rheinland
Atmospheric Pressure Limitation