Boston Scientific SpyGlass DS User manual

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SpyGlass™ DS
Digital Controller
User’s Manual
User’s Manual ����������������������������������������������������������������������������������������������������������2

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Boston Scientific (Master Brand User’s ManualTemplate 8.5in x 11in, 91006665 AE), User Manual, MB, SpyGlass DS Digital Controller, Global, 50511978-01B_pretrans
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TABLE OF CONTENTS
INTRODUCTION ������������������������������������������������������������������������������������������������������������������������������������������������������������������� 3
Where to Get Help �������������������������������������������������������������������������������������������������������������������������������������������������������� 3
DEVICE DESCRIPTION �������������������������������������������������������������������������������������������������������������������������������������������������������� 3
User Information������������������������������������������������������������������������������������������������������������������������������������������������������������ 3
Contents�������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 3
Model Numbers������������������������������������������������������������������������������������������������������������������������������������������������������������� 3
Specifications���������������������������������������������������������������������������������������������������������������������������������������������������������������� 4
INTENDED USE/INDICATIONS FOR USE ������������������������������������������������������������������������������������������������������������������������� 4
CONTRAINDICATIONS�������������������������������������������������������������������������������������������������������������������������������������������������������� 4
WARNINGS��������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 4
PRECAUTIONS ��������������������������������������������������������������������������������������������������������������������������������������������������������������������� 5
ADVERSE EVENTS ��������������������������������������������������������������������������������������������������������������������������������������������������������������� 6
CONFORMANCE TO STANDARDS ������������������������������������������������������������������������������������������������������������������������������������ 6
Essential Performance Statement ����������������������������������������������������������������������������������������������������������������������������� 6
HOW SUPPLIED�������������������������������������������������������������������������������������������������������������������������������������������������������������������� 6
Handling and Storage��������������������������������������������������������������������������������������������������������������������������������������������������� 6
SPYGLASS™ DS DIGITAL CONTROLLER COMPATIBILITY������������������������������������������������������������������������������������������� 7
SETUP AND OPERATION���������������������������������������������������������������������������������������������������������������������������������������������������� 7
Front Panel Features ���������������������������������������������������������������������������������������������������������������������������������������������������� 7
Rear Panel Features ����������������������������������������������������������������������������������������������������������������������������������������������������� 9
Patient Environment ��������������������������������������������������������������������������������������������������������������������������������������������������� 10
Note about Performance ������������������������������������������������������������������������������������������������������������������������������������������� 10
Isolating the Controller from the Main Power Supply ������������������������������������������������������������������������������������������ 10
Software ����������������������������������������������������������������������������������������������������������������������������������������������������������������������� 10
Setup of the Controller ����������������������������������������������������������������������������������������������������������������������������������������������� 10
Starting the Controller������������������������������������������������������������������������������������������������������������������������������������������������ 12
Configure the Monitor for the Video Mode������������������������������������������������������������������������������������������������������������� 14
Adjusting the Brightness of the Video Image and Operating Light ON/OFF button����������������������������������������� 15
Recovering from a Controller Failure����������������������������������������������������������������������������������������������������������������������� 15
Considerations When Using a Laser or EHL Device ��������������������������������������������������������������������������������������������� 16
COMPLETING A PROCEDURE ����������������������������������������������������������������������������������������������������������������������������������������� 16
Using the Controller In an Endoscopy Procedure ������������������������������������������������������������������������������������������������� 16
Shutting Down the Controller������������������������������������������������������������������������������������������������������������������������������������ 16
Routine Inspection and Maintenance ��������������������������������������������������������������������������������������������������������������������� 16
Cleaning and Disinfection ����������������������������������������������������������������������������������������������������������������������������������������� 16
Disposal of the Product, Accessories, and Packing Materials��������������������������������������������������������������������������� 16
TROUBLESHOOTING AND RESPONDING TO ERROR CODES ������������������������������������������������������������������������������������ 17
Troubleshooting Chart������������������������������������������������������������������������������������������������������������������������������������������������ 17
WARRANTY ������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 19
Limited Warranty��������������������������������������������������������������������������������������������������������������������������������������������������������� 19
Obtaining Warranty Service from Boston Scientific Corporation���������������������������������������������������������������������� 19
APPENDICES ���������������������������������������������������������������������������������������������������������������������������������������������������������������������� 19

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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 SpyGlass™
DS Digital Controller (hereafter called the Controller).
The controller is used with a SpyScope™ DS Access and Delivery Catheter (M00546600) or SpyScope DS II
Access and Delivery Catheter (M00546610). The SpyScope DS Access and Delivery Catheter and SpyScope
DS II Access and Delivery Catheter are also called the SpyScope DS Catheter in this user manual.
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 SpyScope DS Catheter,
• Processes the video signals, and
• Outputs video images to a video monitor.
The controller also generates and controls the light transmitted to the tip of the SpyScope DS Catheter to
illuminate the area of interest within the anatomy. Buttons on the controller’s front panel enable you 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 SpyScope DS
Catheter to the controller. The controller provides direct visualization of the pancreatico-biliary duct anatomy
and enables exploratory and endotherapy procedures.
User Information
The controller and these instructions are intended for use by physicians trained in endoscopic pancreatico-
biliary procedures, including endoscopic retrograde cholangio-pancreatoscopy (ERCP).
A thorough understanding of the techniques, principles, clinical applications and risks associated with ERCP
and cholangio-pancreatoscopy procedures is suggested before using the controller as part of the SpyGlass
DS and DS II Direct Visualization System (hereafter referred to as the SpyGlass DS System).
Contents
• One (1) SpyGlass DS Digital Controller
• One (1) 3.1-meter North America power cord (M00546650) or one (1) 3.1-meter Brazil power cord (M0054665B0)
• One (1) 2.0-meter DVI cable
• One (1) 1.8-meter VGA cable
Ensure the package contains the components listed above.
Model Numbers
SpyGlass DS Digital Controller (with North America power cord) M00546650
SpyGlass DS Digital Controller (with Brazil power cord) M0054665B0

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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
230 VAC
International (Brazil)
Length—3.1 meters (10 feet)
Voltage Rating—250 VAC
Current Rating—10 amps
Connector Type—IEC 60320 C13
UL Marking—Yes
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) 6.8 kg (15 lb)
INTENDED USE/INDICATIONS FOR USE
The SpyGlass™ DS and DS II Direct Visualization System is indicated for use in diagnostic and therapeutic
applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The
SpyGlass DS and DS II Direct Visualization System comprises two components: the SpyScope™ DS Access
and Delivery Catheter or SpyScope DS II Access and Delivery Catheter, and the SpyGlass DS Digital Controller.
TheSpyScope DSAccess andDeliveryCatheterand SpyScope DS II AccessandDelivery Catheter are intended
to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic
applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The SpyGlass DS Digital Controller is intended to provide illumination and receive, process, and output images
from the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter for
diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system
including the hepatic ducts.
CONTRAINDICATIONS
Contraindications associated with the use of this device include:
• Patients for whom ERCP is medically contraindicated.
• Contraindications specific to endoscopic pancreatico-biliary duct exploration and cannulation.
WARNINGS
• Read this user manual, the SpyScope DS Catheter directions for use, and the monitor user manual 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.

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• 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.
• The LEDs in the catheter cable receptacle remain hot for a period of time after use. To prevent burns, do
not insert fingers into catheter cable receptacle.
• 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 disinfecting the cabinet and front panel buttons can expose the operator to
biohazardous materials. To prevent exposure to biohazardous materials, disinfect the chassis between
use using the cleaning procedure described in “Cleaning and Disinfection.”
• 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 SpyGlass™ DS System.
• Components added to the SpyGlass DS System 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
system standard. Power cords must be compliant with the system, and a compliant spare power cable is
provided in the power cable pack (M00546250) for this purpose.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the SpyGlass DS System, 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.
PRECAUTIONS
• If you block the controller’s ventilation outlet, the controller can 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. Use the controller on a dedicated
equipment cart such as the SpyGlass Components Travel 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.

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• 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 catheters other than a SpyScope™ DS Catheter to the controller can damage the
controller. Only connect a SpyScope DS Catheter to the controller. See the “SpyGlass DS Digital
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 SpyGlass™ DS System are present and operational. Starting a procedure without the supporting
components present and operational can prolong the procedure.
• Do not use cleaners or disinfectant solutions that contain long-life surfactants. Doing so can leave
conductive residues on the contacts of the catheter connector receptacle. The conductive residues can
lead to malfunctions of the controller.
• Do not clean the LEDs located inside the catheter cable receptacle.
• Use of a cardiac defibrillator while a SpyScope™ DS Catheter remains in a patient can damage the
controller. To prevent damage to the controller when using a defibrillator, remove the SpyScope DS
Catheter 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 use the controller with the SpyScope DS Catheter.
ADVERSE EVENTS
See directions for use for SpyScope DS Catheter for adverse event information.
CONFORMANCE TO STANDARDS
Essential Performance Statement
The controller does not have essential performance as defined by IEC 60601-1 and IEC 60601-2-18.
HOW SUPPLIED
Device supplied non-sterile. Inspect the components for damage. Do not use a component if it appears
damaged. Do not use the components if the package labeling is incomplete or illegible.
Handling and Storage
Environmental Limits During Transportation, Use, and Storage
The controller can be stored between procedures on the endoscopy tower or on a dedicated equipment
cart (Table 1).
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

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Intended Conditions of Use
The controller should be used in a hospital.
SPYGLASS™ DS DIGITAL CONTROLLER COMPATIBILITY
All attached equipment must comply with its applicable IEC standards.
The controller is compatible with:
• SpyScope™ DS Access and Delivery Catheter (M00546600).
• SpyScope DS II Access and Delivery Catheter (M00546610) - compatible with Controllers with software
revision 2.2 only.
• SpyGlass Isolation Transformer (M00546260, M00546240, M00546730). Use is optional, transformer not
included in system.
The controller incorporates standard video signal outputs (i.e. S-Video, DVI, SXGA) to allow connection to
a monitor. Boston-Scientific has tested the following monitors (M00546120) to ensure compatibility with the
controller and IEC standards:
• Sony LMD1951MD monitor
• Sony LMD1950MD monitor
An irrigation pump is required to perform procedures with the SpyGlass DS System. Boston Scientific has tested
the SpyGlass Irrigation Pump (M00546140) to ensure it is compatible with the SpyGlass DS System.
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.
2Connection Cable Receptacle—You plug the connection cable from the SpyScope
DS Catheter into the receptacle during setup of the system.

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Feature Description
3 Indicates you must use BF applied parts.
4
Light On/Off Button—Pressing this button alternately turns the light off and on.
Light On/Off Button—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
Light Brightness Control Buttons—When the light is on, the light brightness
control buttons are illuminated blue. Pressing the button increases the
intensity of the light. Pressing the button decreases the intensity of the light.
6Light 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 light brightness indicator
Illumination State of Light Brightness Indicator Setting Description
Low
Med-Low
Med
Med-High
High

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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
Table 4� Description of back panel features
Feature Description
1 USB port access cover (tool required).
2DVI Output Connector—Video output connector for compatible DVI-capable monitors.
3 Symbol indicating video outputs.
4VGA Output Connector—Video output connector for compatible SXGA-capable
monitors.
5
Two S-video Output Connectors—Video output connectors for compatible
S-video-capable monitors or accessories. [A user-supplied S-Video cable is
required to connect the SpyGlass™ DS Controller to a monitor. The recommended
S-Video cable is ShowMeCables part number 25-235-006.]
6
PAL/NTSC Switch—The switch enables operation of the controller with PAL or
NTSC video formats when using an S-video cable. PAL is the Phase Alternating
Line format. NTSC is the National Television System Committee format.
7
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.

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Feature Description
8 Symbol for potential equalization conductor
9Potential Equalization Conductor—Provides a means of securely linking the
potential equalization conductor of the controller to ground.
10
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 or the SpyGlass™
Isolation Transformer.
11 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 you 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 your controller is displayed on the cable connect screen.
Setup of the Controller
All attached equipment must comply with its applicable IEC standards.

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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 and Disinfection” section.
3. Place the controller and the video monitor on an equipment cart such as the SpyGlass™ Components
Travel Cart or on an existing endoscopy tower in the procedure room. See the “SpyGlass DS Digital
Controller Compatibility” section for additional information if needed.
4. Set the PAL/NTSC video standard switch on the back of the controller as follows:
a. Use of DVI or VGA cable—No PAL/NTSC switch adjustment is required.
b. Use of S-video cable—Set the PAL/NTSC video mode switch on the back of the controller to
match the video mode of the monitor (Figure 4).
5. Use the DVI or VGA cable (or a user-supplied S-Video cable) to connect one of the video input
connectors on the video monitor to one of the video output connectors on the controller.
Note: Connecting the monitor to the controller using the DVI cable provides the highest quality video image.
6. Connect the controller and video monitor power cords to electrical receptacles or an optional
SpyGlass Isolation Transformer.
7. Power on and set the monitor video input based on the cable selected in Step 5. Follow the steps
below to set the monitor’s video input.
Sony LMD 1951 Monitor:
Note: All references to buttons refer to the buttons along the front panel of the monitor.
1. Press Control to unlock the front panel buttons
a. Select the DVI button for DVI operation
b. Select the HD15 for SXGA operation
c. Select the Y/C button for S-Video operation
Sony LMD 1950 Monitor:
Note: All references to buttons refer to the buttons along the front panel of the monitor.
a. Push the Input up arrow to select HD15 for SXGA operation
b. Push the Input up arrow to select DVI for DVI operation
c. Push the Input up arrow to select Y/C for S-Video operation
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 SpyScope™ DS Catheter
does not need to be connected.
9. Configure the monitor for use in DVI, SXGA, or S-video mode following the steps in the “Configure the
Monitor for the Video Mode” section.
Note: Monitor must be configured before beginning a procedure.

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Figure 4� Back panel connection points
2
1
3
3
1. DVI connector
2. VGA connector
3. S-video connector
4. Potential equalization conductor
5. Ensure Pal/NTSC switch is in the correct position
for the video standard used in your country
6. Mains power
5
4
6
Starting the Controller
Followthe stepsbelowto startthecontroller. You canstart thecontrollerwith orwithoutthe catheterconnection
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 trouble shooting section.
(a) Boot screen
(b) Transition screen
b
a

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2. Upon a successful boot up, the monitor displays the cable connect screen (c) showing the software
version (d). Connect the catheter 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 the SpyScope™ DS Catheter is already connected, this screen will not appear, proceed to step 3.
Note: If you do not want the Boston Scientific watermark (e) to appear on 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
3. The controller briefly displays the catheter loading screen (f).
f
(f) Catheter loading screen

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4. Shortly after the catheter loading screen appears, a live video image will appear on the live video
screen (g). If the live image does not appear, consult the trouble shooting section.
g
(g) Live video screen with example image
Configure the Monitor for the Video Mode
Configure the monitor according to the monitor’s user guide. Recommendations for the Sony LMD1951MD and
LMD1950MD monitors are as follows:
Option 1—(Recommended)—Configure monitor for SXGA or DVI mode.
Option 2—Configure monitor for S-Video mode.
Option 1—Configure monitor for SXGA or DVI mode�
Note: All references to buttons refer to the buttons along the front panel of the monitor.
Configure the LMD1951MD Monitor for SXGA or DVI
Recall the default monitor setting by:
a. Pressing User Mem to open the User Memory Screen.
b. Highlight Default in the User Memory Screen window.
c. Press Enter.
Configure the LMD1950MD Monitor for SXGA or DVI
Recall the default monitor setting by:
a. Pressing User Memory to open the User Memory Screen.
b. Highlight Default in the User Memory Screen window.
c. Press Enter.
Option 2—Configure monitor for S-Video mode�
Note: All references to buttons refer to the buttons along the front panel of the monitor.
Configure the LMD1951MD Monitor for S-Video
1. Recall the default monitor setting by:
a. Pressing User Mem to open the User Memory Screen.
b. Highlight Default in the User Memory Screen window.
c. Press Enter.
2. Press Menu to open the status window.
3. Press the menu ‘–‘ button multiple times until the User Config window is displayed.
4. Press Enter to highlight the System Setting line in yellow.
5. Press Enter to open the User Config window.

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6. Press the menu ‘–‘ button multiple times to highlight the I/P Mode line in yellow.
7. Press Enter to highlight the I/P Mode.
8. Press the menu ‘–‘ button until the I/P Mode is set to Field Merge.
9. Press Enter.
10. Press Menu to close the screen menus.
Configure the LMD1950MD Monitor for S-Video
Recall the default monitor setting by:
a. Pressing User Memory to open the User Memory Screen.
b. Highlight Default in the User Memory Screen window.
c. Press Enter.
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 controller light source between ON and OFF state. To operate the
light On/Off button the controller must be powered on and a SpyScope™ DS Catheter must be connected to
the controller. Button illuminates white when the light is off and blue when it is on.
1. Increases image brightness
(light brightness control button)
2. Decreases image brightness
(light brightness control button)
3. Image brightness scale
4. Light ON/OFF button
1
3
2
4
Recovering from a Controller Failure
There are two possible failure modes: (1) unintended controller shutdown, and (2) controller lock up.
Recovery from Unintended Shutdown
Follow these steps to recover from an unintended controller shutdown:
1. Remove any accessory from the SpyScope DS Catheter.
2. Remove the SpyScope DS Catheter from the patient.
3. Unplug the SpyScope DS Catheter from the controller.
4. Press the controller’s Power button to restart the controller.
5. If the controller fails to start, contact Boston Scientific.
Recovery from a Controller Lock Up
Follow these steps to recover from a controller lock up:
1. Remove any accessory from the SpyScope DS Catheter.
2. Remove the SpyScope DS Catheter from the patient.
3. Unplug the SpyScope DS Catheter from the controller.
4. Press and hold the power button until the controller shuts down.
5 Press the controller’s Power button to restart the controller.
6. If the controller fails to start, contact Boston Scientific.

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Considerations When Using a Laser or EHL Device
When activating energy from a laser or electrohydraulic lithotripsy (EHL) generator during lithotripsy, you
can expect to see a bright flash on the video monitor and possibly a momentary disruption in the video
quality. This reaction is normal and is not indicative of a defect or operating problem with the controller or
SpyScope™DS Catheter.
COMPLETING A PROCEDURE
The procedure below describes the procedural use of the controller and assumes you have 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 and Disinfection” section.
2. Power up the controller.
3. Configure the monitor.
4. Connect a SpyScope DS Catheter to the front panel connector.
5. Complete the procedure as outlined in SpyScope DS Catheter 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 SpyScope DS Catheter from the patient following the instructions in
the SpyScope DS Catheter directions for use.
2. Disconnect the catheter cable from the front of the controller by pushing down on the 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 you are shutting the controller down after finishing a procedure, dispose of the SpyScope DS
Catheter as described in the SpyScope DS Catheter directions for use. Then clean the controller as
directed in the “Cleaning and Disinfection” 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 functioning 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 and Disinfection
Disconnect the power cord before cleaning or disinfecting the unit. Use a 15 to 70 percent isopropyl alcohol in
purified water solution and a cloth to clean the controller enclosure, front panel, and power cable. Do not allow fluids
to enter the enclosure, power cable connections, catheter 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 the relevant regulations and laws in your country.
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.

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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.
Catheter connection
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.
Catheter cable is not
properly connected to
controller
Ensure the plug on the catheter connection cable
is firmly inserted into the connector with the
locking tab facing up. Ensure connection terminals
are dry and clean.
SpyScope™ DS Catheter is
broken or defective Replace SpyScope DS Catheter.
Illumination light is off
Press illumination light button to turn on light.
(The light On/Off button should be illuminated
blue.)
Symptom Possible Cause Corrective Action
Catheter connection
cable is plugged into
the controller, but cable
connection screen is still
displayed.
Catheter cable is not
properly connected to
controller
Ensure the plug on the catheter connection cable
is firmly inserted into the connector with the
locking tab facing up. Ensure connection terminals
are dry and clean.
SpyScope DS Catheter is
broken or defective Replace SpyScope DS Catheter.

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Video image is too dark.
Brightness setting is
too low
Adjust brightness using brightness
control buttons.
Debris covering the distal
tip of the SpyScope™ DS
Catheter
Clean the distal tip by irrigating, or removing &
wiping it with 15 to 70 percent isopropyl alcohol in
purified water solution using a cotton swab.
SpyScope DS Catheter fiber
optic is damaged Replace SpyScope DS Catheter.
Video image is too bright
Brightness setting is
too high
Adjust brightness using brightness
control buttons.
Video cable connect to
monitor output
Ensure video cable is connected into monitor
video input and not output.
Video image is blurry,
scrambled, inadequate,
or distorted
Controller is too close to
other electrical medical
equipment
Ensure controller is placed as directed in Table 9
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 image is
scrambled or displays
unnatural colors
PAL/NTSC switch is set
improperly
Determine which video mode standard you
monitor uses and set the PAL/NTSC switch
accordingly using the recessed switch on the
rear panel. Once switch is set correctly power on
the controller.
Symptom Possible Cause Corrective Action
Video image is blurry,
distorted, or otherwise
not acceptable
Debris covering the distal
tip of the SpyScope DS
Catheter
Clean the distal tip by irrigating or removing &
wiping it with 15 to 70 percent isopropyl alcohol in
purified water solution using a cotton swab.
Video monitor is not
compatible with controller Replace monitor with compatible monitor.
Chassis is warm-to-hot
to the touch
chassis 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.
If any of these problems persist, please contact BSC for repair or replacement information.

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WARRANTY
Limited Warranty
BostonScientificCorporation(BSC)warrantsforoneyearfromthedateofpurchasethatreasonablecarehasbeen
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-SpyGlass™ DS System Catheter. 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.
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 SpyGlass DS Digital Controller
• Appendix 5—Medical Design Criteria and Specifications

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Appendix 1—Guidance and Manufacturer’s Declaration-Electromagnetic Emissions
The SpyGlass™ DS Digital Controller is intended for use in the electromagnetic environment specified below
(Table 6). The customer or the user of the SpyGlass DS Digital 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 SpyGlass DS Digital 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 SpyGlass DS Digital 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
Not
Applicable
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Not
Applicable
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