Device Set-Up

Captivator™ EMR

ligation-assisted Endoscopic Mucosal Resection (EMR) of

the Upper Gastrointestinal (GI) tract.

Injection AdapterPlastic Sheath

Handle

Captivator Snare

Ligator Cap

Pathology Kit

This overview is provided for illustrative purposes only and is intended only as a brief summary of how the operational steps during a procedure are generally performed. Please refer to the Directions For Use for complete instructions.

Information not intended for distribution in France.

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.

www.bostonscientifi c.eu

ENDO-328803-AA July 2015

1 Attach Handle to Endoscope

2 Attach Ligator Cap to Trip Wire

3 Attach Ligator Cap to Endoscope

4 Complete Preparation for Use

PathologyKit Steps

Step 1

Step 2

Step 3

Remove clips from plastic sheath (illustration 2)

Straighten the endoscope

Feed sheath through biopsy cap, advancingthrough the working channel of the endoscopeuntil it exits through the distal end (illustration 3)

Step 5

Step 7

Step 11

Step 8

Remove the plastic sheath from scope by pulling it from the distal end of the endoscope until it is fully detached and the metal trip wire is visible (illustration 6).

Discard the plastic sheath.

Remove the slack in the line using the S-shaped knob by turning away from the scope (illustration 10). Stop turning when the soft proximal end of ligator cap is almost touching the distal end of endoscope.

If desired, apply lubricant to the distal endof the exterior of the endoscope sheath.

Turn the S-shaped knob to take up remaining slack until the white suture is visibly taut.

DO NOT OVERTIGHTEN.

If tissue retrieval is desired following pseudopolypresection, follow standard institutional guidelines.

Retrieved tissue samples may be placed in CaptivatorEMR Pathology Kit per standard hospital procedures.

Illustration 2

Illustration 3

Illustration 6

Illustration 10

Illustration 13

Illustration 4

Illustration 5

Step 4 Firmly seat the handle into the biopsy cap(illustration 4) and snap scope fastener onto endoscope (illustration 5)

Kit components

Step 6 Attach suture loop of ligator cap to the loop on distal end of metal trip wire (illustration 7) by threading suture loop through trip wire loop (illustration 8),then threading ligator cap throughsuture loop (illustration 9)

Illustration 7

Illustration 12

Illustration 14

Kit 1 Kit 2 Kit 3 Kit 4 Kit 5

Illustration 8 Illustration 9

Illustration 11

Step 9

Step 12

Step 10

Line up the arrow on the soft proximal end of the ligator cap with the working channel of the endoscope (illustration 11).

Secure ligator cap to endoscope by twisting or rocking softer proximal end of ligator cap while pushing it onto distal tip of endoscope (illustration 12). The ligator cap should be pushed until tip of endoscope is up againstthe inner rim of ligator cap so no blue bands are in view.

Carefully remove the shrink wrap from the ligator cap by pulling marked tab from the soft end of the cap, without disturbing the ligator bands and threads.