1�1 Safe Use Requires Reading The User'S Manual; Clinical Information; 2�1 Indications For Use And Intended Use; 2�2 Contraindications - Boston Scientific LithoVue Manual Del Usuario

(d) Displays the video images. The system workstation can also send the video signals via a DVI
Cable for display on a user-supplied video monitor. When using a user-supplied video monitor,
the system will duplicate the video image, but will not duplicate the system controls.
(e) Provides the user interface.
1�1 SAFE USE rEQUIrES rEAdInG tHE USEr'S MAnUAL
Prior to using the LithoVue™ System, you must read this User's Manual and the LithoVue Single-Use
Digital Flexible Ureteroscope Directions for Use to become familiar with the LithoVue System's features
and controls. This manual and the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use
provide the information necessary for inspecting, preparing and operating the system.
Failure to thoroughly understand and follow all instructions, cautions and warnings provided in this
User's Manual and the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use may result
in injury to the patient and/or user, and/or may result in damage to, or malfunction of, this equipment.
Additionally, damage to other equipment or property may result.
Follow all instructions, cautions, and warnings provided with all products and equipment to be used
in conjunction with the LithoVue System to avoid any possible hazards due to device incompatibility.
If the instructions are unclear to you, contact Boston Scientific for assistance, using the information
found in Section 8 "Service and Warranty".
Keep this User's Manual in an accessible location.

2 clinical Information

2�1 IndIcAtIonS For USE And IntEndEd USE
The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract
(urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes.
It can also be used in conjunction with endoscopic accessories to perform various diagnostic and
therapeutic procedures in the urinary tract.
2�2 contrAIndIcAtIonS
Contraindications for this device are those specific to urinary tract endoscopy.
Diagnostic or therapeutic ureteroscopy is contraindicated in people with an untreated urinary tract infection.
Other contraindications to therapeutic ureteroscopy (e.g., lithotripsy, endopyelotomy, tumor therapy) are
more numerous and can mirror those associated with the corresponding open surgical interventions.
Patients on anticoagulants or with coagulopathies should be managed appropriately.
2�3 USEr trAInInG, KnoWLEdGE, And SKILLS
Read the entire User's Manual and LithoVue Single-Use Digital Flexible Ureteroscope Directions for
Use before using the LithoVue System. Study labeling thoroughly for safe handling and storage. Use the
LithoVue System as intended.
The LithoVue System Workstation should only be assembled and installed by a trained biomedical technician.
Only physicians who have ureteroscopic, diagnostic, and therapeutic training should use the LithoVue
System. A thorough understanding of the techniques, principles, clinical applications, and risks associated
with endoscopic urinary tract procedures is necessary before using this device. This includes, but is not
limited to devices used in laser lithotripsy, administration of irrigation/contrast, and use of procedural
accessories such as baskets/forceps, access sheaths, guidewires, and antiretropulsion devices.
Nursing support staff should have reasonable experience with common medical equipment and
urology procedures.
User's Manual 7
Black (K) ∆E ≤5.0