50866131-01 Rev. A
Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A) eDFU
, MB, EXAL
T Controller
, EN, 508661
31
-0
1 R
ev
. 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
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