Boston SpyGlass User Reference Manual

SpyGlass

™

Direct Visualisation System and Capital Components

User Reference Guide

RCS Nanterre B420 668 420

© 2008 Boston Scientific Corporation
or its affiliates. All rights reserved.
DINEN D2174E A

All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on
the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling
supplied with each device. Information for the use only in countries with applicable health authority product registrations.

PSST 4893 Printed in Germany by medicalvision.

www.bostonscientific.com
www.bostonscientific-international.com

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This overview is provided for illustrative purposes only and is intended only as a brief summary of how the procedural
steps for using the SpyGlass™ Direct Visualisation System are generally performed. Please refer to the Directions For Use
for complete instructions.

SECTION PAGE

1 SpyGlass™ System Capital Components

and Consumable Devices 2

2 Verifying Power 4

3 Pre-Procedure Setup 6

4 Image Quality Test 8

5 Preparing and Using the

SpyScope™ Access and

Delivery Catheter 10

6 Accessory Passage 12

7 Probe and Ocular Care and Storage 14

8 SpyGlass System Components

Ordering Information 16

9 Intended Use 18

table

of

contents

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1

Figure 2 Figure 3

2

3

SpyGlass™ System Capital Components
and Consumable Devices

Video Monitor

SpyGlass Ocular

3-Joint Arm

SpyGlass Direct

Visualisation Probe

Lightsource Cable

Irrigation Pump

Isolation

Transformer

Pump Footswitch

SpyGlass

Lightsource

SpyGlass Camera

SpyGlass

Component Cart

Figure 1

SpyGlass

™

System Capital Components and

Consumable Devices (Figure 1)

The capital system contains several components that will require assembly:

• SpyGlass Camera – Auto shutter camera with 6.4 mm CCD chip

• SpyGlass Ocular – optical coupler that interfaces with the SpyGlass Probe

and the video camera head

• SpyGlass Lightsource – 300 watt, high intensity white light

• SpyGlass Travel Cart – includes 3-joint arm for extension

• Isolation Transformer

• Irrigation Pump with Footswitch

Consumable Devices

SpyGlass Fibre Optic Probe (Figure 2)

• 6000 pixel fibre optic probe

• 70 degree field view

• 0.33 in (8.4 mm) outside diameter

• 365 cm long

•

Fibre optic bundle surrounded by light fibres

• Multiple use device that is reprocessed after each use

SpyScope

™

10 F (3.3 mm) Access & Delivery Catheter (Figure 3)

• Multi-lumen catheter including:

- One 1.2 mm accessory channel

- Two independent irrigation channels

- One 1.0 mm optical channel

- Four steering wires embedded in length of the catheter

SpyBite™ Biopsy Forceps

• Minimum working channel of 1.2 mm required

• Jaw outside diameter: 1 mm closed, 4 mm open

• 286 cm working length

• Single-use device

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2

Figure 4

4

5

Verifying Power

NOTE: A clear image will not be seen until the SpyGlass™ Probe is connected.

To prepare for a procedure, check that all of the capital components are plugged into
the isolation transformer mounted below the bot tom shelf of the cart. Verify that the
power inlet cord attached to the isolation transformer is plugged into a wall outlet.

• Turn on the power switch on the isolation transformer.

• Turn the power on for the monitor, lightsource, camera and irrigation pump.

(Figure 4)

• Verify that an image appears on the video monitor. The monitor will

have a dull, indistinct white-gray image.

• Do not shine light directly into the camera as this may damage the

imaging sensor.

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3

Figure 5

Figure 6

6

7

Pre-Procedure Set-Up

NOTE: e “tongue” on the ocular holder is a slightly raised area on
the top of the C-shaped slot.

The SpyGlass™ System procedure is an extension of a typical ERCP, so initial steps
are the same as or similar to an ERCP. Pre-procedure device set-up is required.
A review of select pre-procedure set-up and typical procedural steps are listed
below. For complete instructions, please refer to the individual component
Directions for Use.

Pre-Procedure Set-Up

• Set up video camera and ocular

– Thread ocular into front of video camera head

• If 3-joint arm is used, attach ocular to holder

• Line up the groove in the ocular with the tongue on the ocular holder

– Push the ocular into the C-shaped receptacle on the ocular holder until it
contacts the far wall of the holder

– Rotate the ocular back and forth until an audible click can be heard, which
verifies that the ocular is locked in place

• Remove probe and verify that it has been high-level disinfected or sterilised

– Inspect probe for rough surfaces, sharp edges or protrusions
– Do not use if:

• Outer jacket is torn or abraded through

• Probe is kinked and/or permanently bent
– Attach probe to ocular (Figure 5)

•

Attach light cable to adapter light post on the probe (Figure 6)

•

Turn on video camera, monitor and lightsource (if they are not already on)

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4

Figure 7

8

9

Image Quality Test

NOTE: Lightsource cable should be attached to SpyGlass Probe at this point.

NOTE: Refocusing should not be required once the procedure begins.

Before a procedure, the following steps should be taken to test the image quality
of the capital equipment and the SpyGlass

™

Probe image:

•

Turn the lightsource to a mid-level power

• Verify a proper image using the SpyGlass Probe test target. Refer to the white

index card included in the SpyGlass Probe packaging.

• Adjust focus ring so image becomes clear within 1 cm of SpyGlass Probe

test target. (Figure 7)

•

Point the probe at a white object. Press the white balance button on the front

of the camera control unit.

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5

Figure 8

Figure 9

10

11

Preparing and Using the SpyScope™
Access and Delivery Catheter

NOTE: To avoid damage to the probe, pull the probe a few millimeters back into
the catheter during insertion of the catheter and probe into the duodenoscope.

NOTE: If a guidewire is not required for cannulation and the SpyBite™ Biopsy
Forceps will be used, you may preload the SpyBite Biopsy Forceps prior to passing
the SpyScope Catheter.

NOTE: Ensure the elevator of the duodenoscope is down as the SpyScope Catheter
exits the duodenoscope.

• Attach the SpyScope Catheter to the duodenoscope by securing the plastic strap

onto the handle of the duodenoscope.

• Through the optic port on the handle of the SpyScope Access and Delivery

Catheter, load the SpyGlass™ Probe, and advance using short strokes. (Figure 8)
You’ll be able to see the lighted, fibre optic probe going through the catheter.

• Advance the probe until it is flush with the end of the SpyScope Catheter.

As you approach the distal end of the SpyScope Catheter, you will observe on
the monitor that the visible image changes from a translucent appearance to
teal/blue.

• Check to be sure there is still a good image on the monitor to verify the probe

was not damaged during insertion into the SpyScope Catheter.

• If a guidewire will be used in the procedure, backload a 450 cm wire into the

working channel of the SpyScope Catheter before delivering the catheter and
probe through the duodenoscope. (Figure 9)

•

Ensure the probe is pulled back into the catheter several millimeters to avoid

damage to the probe.

• Using short strokes, insert the SpyScope Catheter and SpyGlass Probe into

the working channel of the duodenoscope, over the elevator and into the
Ampulla of Vater.

• Adjust the position of the probe inside the SpyScope Catheter as required during

the procedure.

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6

Figure 10

• If not already preloaded, insert the SpyBite™ Biopsy Forceps into the device port

of the SpyScope™ Catheter. (Figure 10)

•

Advance the SpyBite Biopsy Forceps using short strokes. Once the forceps
exit the tip of the SpyScope Catheter, the forceps can be extended to obtain
a tissue sample.

• Before advancing the SpyBite Biopsy Forceps through the SpyScope Catheter,

apply light pressure on the handle to make sure the jaws remain closed.

• Ensure the elevator of the duodenoscope is down as the SpyScope Catheter

exits the duodenoscope.

12

13

Accessory Passage

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7

Figure 11

Figure 12

14

15

Probe and Ocular Care and Storage

NOTE: e SpyGlass Probe should be coiled and transported using two hands as
shown in Figure 12.

NOTE: e probe contains no hazardous materials. When the probe no longer
delivers a satisfactory image, dispose of the device in accordance with hospital,
administrative and/or local government policy.

• When the procedure is complete, pull the SpyGlass™ Probe a few millimeters

back into the SpyScope™ Catheter, detach the light cable from the probe by
firmly holding the aluminum portion of the probe and detaching distal portion
of the light cable.

• Detach the SpyGlass Probe from the ocular by rotating the probe in a

counter-clockwise direction, and then pulling the probe straight off the ocular.

• Wipe the SpyGlass Probe distal and proximal lenses and ocular clean using a

soft cloth or gauze. (Figure 11) Do not leave any residue on the window of
the ocular. The ocular can be stored on the camera head or in the drawer of
the SpyGlass Components Cart.

• After scope is removed from the body, carefully remove the probe from the scope.

Wipe with an enzymatic cleaner and then carefully wind the probe in the tray
for cleaning.

• With proper handling and care, the SpyGlass Probe can be used for multiple uses.

Before each use, the probe is reprocessed according to the recommended methods
identified in the reprocessing section of the SpyGlass Probe Directions for Use.

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8

CAPITAL COMPONENTS

PART NUMBER COMPONENT DIMENSIONS in cm WEIGHT

M00546160

Components Cart

1

49.5 W x 122.6 H x 53.3 D 68 kg

M00546190

Lightsource 32 W x 14.2 H x 24.6 D 5.89 kg

M00546110

Camera 240V (PAL)

2

32 W x 10.2 H x 35.6 D 4.53 kg

M00546120

Video Monitor 48.3 cm (19“) n/a

M00546140

Irrigation Pump with Footswitch 20.3 W x 14 H x 16.5 D 2.26 kg

M00546070

3-Joint Arm with Clamp

1

80 cm long (extended) 0.73 kg

M00546040

Ocular <0.226 kg

M00546210

Light Cable 12.7 cm long <0.453 kg

M00546240

Isolation Transformer (240 V) 30.5 W x 11.4 H x 21.8 D 10.432 kg

M00546250

Power Cable Pack

(Cables included): 2 – 0.5 meter

1 – 1 meter
2 – 1.5 meter

n/a

M00546060

Large Probe Storage Tray

3

27.9 W x 5.1 H x 20.3 D 1.134 kg

M00546050

Small Probe Storage Tray

3

17.8 W x 5.1 H x 14 D 0.589 kg

CONSUMABLE DEVICES

PART NUMBER COMPONENT WORKING LENGTH MINIMUM WORKING CHANNEL

M00546270

SpyBite

™

Biopsy Forceps 286 cm 1.2 mm

M00546030

SpyGlass Probe 231 cm 1 mm

M00546230

SpyScope

™

Access & Delivery Catheter 230 cm 4.2 mm

M00546451

SpyGlass Irrigation Tube Set (Box 10)

16

17

SpyGlass™ System Components
Ordering Information

NOTE: SpyGlass System, when completely assembled, has an approximate space footprint of 49.5 cm W x 53.3 cm D.

Total weight of the assembled system is approximately 97.068 kg.

1

Cart includes a 3-joint arm with connector for ocular, but no table clamp

2

Camera System includes camera controller (box), camera head, and video cables for connection to monitor.

PAL version does not contain a power cord.

3

Large Storage Trays are recommended unless the customer reprocesses in a machine, into which the large

storage trays will not fit. In this case, order two small storage trays, #M00546050.

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9

18

19

Intended Use

CAPITAL COMPONENTS

SpyGlass™ Camera System

INDICAT IONS FOR USE

The Spy Glass Camera Syst em is for use during diagnos tic and/or surgic al procedures wh en endoscopic vide o
assistan ce is required.

WARNIN G

Operato rs who are not traine d and qualified to perf orm endoscopic pr ocedures should no t use this device.
Always ex ercise safety p recautions when u sing electrical equip ment to prevent op erator and patien t shock,

fire hazar d, or equipment damage . When implemented f or therapeutic app lications, a second e quivalent
camera sho uld be available in case the p rimary camera s tops working.

CONTRAINDICATIONS

None know n.

SpyGlass Lightsource

INDICAT IONS FOR USE

Boston S cientific SpyGlass L ightsource is use d for surgical lighting an d other applications .

WARNIN G

Operato rs who are not traine d and qualified to perf orm endoscopic pr ocedures should no t use this device.
When implem ented for therap eutic applications, a s econd equivalent ligh tsource should be a vailable in case the

primary lig htsource stop s working.

CONTRAINDICATIONS

None know n.

Irrigation Pump and Footswitch

INDICAT IONS FOR USE

To provide irrig ation during endosc opic surgical proce dures.

WARNIN G

Operato rs who are not traine d and qualified to perf orm endoscopic pr ocedures should no t use this device.

CONTRAINDICATIONS

None know n.

Isolation Transformer

INTE NDED USE

The Isolat ion Transformer is inten ded for applications w here medical devic es require improve d electrical isolatio n
and/or r educed leakage cur rent to comply wit h existing safet y standards. Wi th the Isolation Transfo rmer connecte d
betwe en the device and the w all outlet where the d evice is installed, the l eakage current and t he electrical isola tion
of the inst alled device will be that of t he Isolation Transfor mer.

SpyGlass Light Cable

INDICAT IONS FOR USE

Boston S cientific Light Cabl e is for use with cyst oscope, arthro scopes, pediatr ic endoscopes, an d others.

WARNIN G

Operato rs who are not traine d and qualified to perf orm endoscopic pr ocedures should no t use this device.
When implem ented for therap eutic applications, a s econd equivalent ligh t cable should be available in c ase the
primary lig ht cable stops wor king.

CONTRAINDICATIONS

None know n.

CONSUMABLE DEVICES

SpyScope™ Access and Delivery Catheter

INTENDED USE

The device is intended to guide the SpyGlass

™

Direct Visualisation Probe or other Visualisation probe and various

accessory devices into the biliary duct system during endoscopic biliary duct exploration procedures.

INDICATIONS FOR USE

The SpyScope Device is intended to guide both optical and accessory devices for diagnostic and therapeutic
applications during endoscopic procedures in the biliary system including the hepatic ducts.

CONTRAINDICATIONS

Contraindications for this device are those specific to endoscopic biliary duct exploration and cannulation.

SpyGlass Direct Visualisation Probe and Ocular

INTENDED USE

The SpyGlass Probe and Ocular have been designed to examine the biliary system and associated ducts and organs.

INDICATIONS FOR USE

The SpyGlass Probe and Ocular are intended to provide direct visualisation for examination for diagnostic and
therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts.

CONTRAINDICATIONS

Contraindications associated with the use of the SpyGlass Probe and Ocular include:

• Patientsforwhomendoscopicproceduresaremedicallycontraindicated.

• Patientsforwhomendoscopicretrogradecholangiopancreatography(ERCP)ismedicallycontraindicated.

• AnyuseotherthanthosespecicallyoutlinedundertheIndic ations for Use.

SpyBite™ Biopsy Forceps

INTENDED USE

The SpyBite Biopsy Forceps are designed to collect tissue samples endoscopically for histologic examination.
These instruments should not be used for any purpose other than the intended function.

INDICATIONS FOR USE

The SpyBite Biopsy Forceps are indicated for tissue acquisition in the pancreaticobiliary system.

CONTRAINDICATIONS

Contraindications for this device are those specific to endoscopic retrograde cholangiopancreatography
(ERCP) procedures.

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Notes

20

21

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