Prescriptive Information
Refer to the operator's manual for complete instructions for use.
SpyGlass System Consumable Devices:
SpyGlass Direct Visualization 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 visualization 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 specifically outlined under the Indications for Use.
SpyScope® Access and Delivery Catheter
INTENDED USE
The device is intended to guide the SpyGlass Direct Visualization Probe or other visualization probe and various accessory devices into the biliary duct system during endoscopic biliary duct exploration procedures.
INDICATIONS FOR USE
The SpyScope Catheter 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 System Capital Components:
SpyGlass Camera System
INDICATIONS FOR USE
The SpyGlass Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
WARNING
Operators who are not trained and qualified to perform endoscopic procedures should not use this device.
Always exercise safety precautions when using electrical equipment to prevent operator and patient shock, fire hazard, or equipment damage. When implemented for therapeutic applications, a second equivalent camera should be available in case the primary camera stops working.
CONTRAINDICATIONS
None known.
SpyGlass Lightsource
INDICATIONS FOR USE
Boston Scientific SpyGlass Light Source is used for surgical lighting and other applications.
WARNING
Operators who are not trained and qualified to perform endoscopic procedures should not use this device.
When implemented for therapeutic applications, a second equivalent light source should be available in case the primary light source stops working.
CONTRAINDICATIONS
None known.
Irrigation Pump and Footswitch
INDICATIONS FOR USE
To provide irrigation during endoscopic surgical procedures.
WARNING
Operators who are not trained and qualified to perform endoscopic procedures should not use this device.
CONTRAINDICATIONS
None known.
Isolation Transformer
INTENDED USE
The Isolation Transformer is intended for applications where medical devices require improved electrical isolation and/or reduced leakage current to comply with existing safety standards. With the Isolation Transformer connected between the device and the wall outlet where the device is installed, the leakage current and the electrical isolation of the installed device will be that of the Isolation Transformer.
SpyGlass Light Cable
INDICATIONS FOR USE
SpyGlass Light Cable is for use with cystoscope, arthroscopes, pediatric endoscopes, and others.
WARNING
Operators who are not trained and qualified to perform endoscopic procedures should not use this device.
Always exercise safety precautions when using electrical equipment to prevent operator and patient shock, fire hazard, or equipment damage. When implemented for therapeutic applications, a second equivalent light cable should be available in case the primary light cable stops working.
CONTRAINDICATIONS
None known.
POTENTIAL COMPLICATIONS
Please be aware that potential complications may arise even with the proper use of medical devices. Accordingly, these devices should only be used by persons qualified in the procedures for which is indicated.
CAUTIONS
Cautions can be found in the product labeling supplied with each device. CAUTION: Federal(USA) law restricts these devices to sale by or on the order of a physician.
