2�5 Precautions - Boston Scientific LithoVue Manuel D'utilisation

• Prior to use of a cardiac defibrillator, remove the LithoVue™ Flexscope from the patient. Failure to
remove the LithoVue Flexscope from a patient during use of a cardiac defibrillator could result in
damage to the system due to the discharge of the cardiac defibrillator.
• The use of accessories, a power supply and/or cables other than those specified or supplied as
spare parts from Boston Scientific may increase electromagnetic emissions or decrease immunity
of the LithoVue System.
• When the LithoVue System is used with other electrical medical equipment, the applied parts
must be Type BF or Type CF applied parts.
• Components added to the 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) or other country equivalent. In addition, the user must ensure the new
configuration complies with local regulations and hospital requirements for electrical safety.
• If the System Workstation stops functioning during a procedure, follow the procedure described
in Section 7 "Troubleshooting".
• Using a System Workstation without disinfecting it can expose the operator to bio-hazardous
materials. To prevent exposure to bio-hazardous materials, disinfect the System Workstation between
uses using the cleaning procedure describe in Section 6.1 "Cleaning the System Workstation".
2�5 PrEcAUtIonS
• Only use the LithoVue Flexscope in conjunction with the LithoVue System Workstation.
Connection to other devices may cause device or property damage or operator injury.
• Only physicians with adequate ureteroscopic training should perform procedures with the
LithoVue Flexscope. Consult the medical literature regarding techniques, complications, and
hazards prior to any procedure.
• Use the LithoVue Flexscope with caution in patients who have undergone previous urinary tract
reconstructive surgery or with known strictures. These conditions may prevent passage of the
flexible scope shaft.
• 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.
• The LithoVue System has been tested and shown compatible with laser lithotripsy devices. The use
of other energized procedural devices may cause loss of image, device damage, or patient injury.
• When using the LithoVue Flexscope with a laser lithotripsy device, all personnel within the
treatment room shall wear protective laser eyewear in accordance with the laser manufacturer's
Instructions for Use.
• Do not use accessories that fail to meet the compatibility requirements of the LithoVue Flexscope as
stated in the Lithovue Single-Use Digital Flexible Ureteroscope Directions for Use. Doing so may cause
damage to the LithoVue Flexscope, System Workstation and/or accessory..
• To ensure satisfactory LithoVue System performance, perform the prescribed inspections and
operational checks on the LithoVue Flexscope described in the Lithovue Single-Use Digital Flexible
Ureteroscope Directions for Use before use. Additionally, verify the System Workstation is properly
installed. See Section 3.2."Confirming Installation" for more information.
User's Manual 9
Black (K) ∆E ≤5.0