2�4 Warnings - Boston Scientific LithoVue Manuel D'utilisation

2�4 WArnInGS
• Do not use the LithoVue™ System in the presence of flammable fluids and gases such as alcohol or
oxygen. Doing so can result in fire and burns to the operator and patient.
• Do not insert or advance the LithoVue Flexscope unless there is a clear live endoscopic view of the lumen
through which the scope is being advanced (or confirm with visualization by other imaging modalities).
Doing so can cause patient injury such as perforation, avulsion, hemorrhage, or urothelial damage.
• In the event that the live endoscopic image is lost, do not advance or insert the LithoVue Flexscope
and do not insert, advance or actuate accessories. Doing so can cause patient injury such as
perforation, avulsion, hemorrhage, or urothelial damage.
• Do not use excessive force when advancing or withdrawing the scope. Doing so can cause
patient injury such as perforation, hemorrhage or urothelial damage or damage to the LithoVue
Flexscope. If resistance is felt during advancement or withdrawal of the scope, investigate the
source of resistance and take remedial action (e.g., fluoroscopy, contrast injection).
• Do not force the distal tip of the LithoVue Flexscope against the sidewall of the ureter or renal pelvis.
Doing so can cause patient injury such as perforation, avulsion, hemorrhage or urothelial damage.
• Do not use excessive force when advancing or withdrawing an accessory within the LithoVue
Flexscope. Doing so can cause patient injury such as perforation, avulsion, hemorrhage, urothelial
damage or damage to the LithoVue Flexscope.
• When inserting or using accessories, maintain continuous visualization of the distal tip. Ensure
the distance between the distal tip of the LithoVue Flexscope and the object in view is greater
than the LithoVue Flexscope's minimum visible distance. Failure to do so may result in the
accessories causing patient injury such as perforation, hemorrhage or urothelial damage.
• Do not withdraw a laser fiber back into the LithoVue Flexscope while the laser is firing. Doing so
may cause patient injury and/or scope damage.
• Do not look directly into the light emitted from the LithoVue Flexscope. Doing so can result in eye injury.
• Verify ground isolation when setting up and using accessories from different manufacturers.
Failure to do so can result in shocks and accessory malfunction leading to patient injury.
• Do not open the handle of the LithoVue Flexscope. Doing so can damage the waterproof seals and
result in risk of electric shock.
• The LithoVue Flexscope is a single-use device and there are no serviceable parts. Do not repair
damaged or non-operating LithoVue Flexscopes. Do not use the LithoVue Flexscope if damage is
discovered or suspected.
• Do not excessively bend the flexible shaft or the articulating section of the LithoVue Flexscope as
this may break or kink the shaft.
• If damage to the LithoVue Flexscope occurs or it malfunctions during a procedure, stop using the
LithoVue Flexscope immediately. See Section 7 "Troubleshooting" for more information. Continue
the procedure with a new LithoVue Flexscope, as appropriate.
• No modification of this equipment is allowed. Do not attempt to repair or alter any components/
parts of the LithoVue System Workstation. The LithoVue System Workstation contains no operator-
serviceable components. All repairs and servicing are to be performed only by authorized Boston
Scientific service personnel. See Section 8 "Service and Warranty" for additional information.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth. Prior to installation, ensure that the selected hospital's electrical outlet has a
proper ground connection and complies with the information listed on the label located on the
rear of the Touch PC.
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Black (K) ∆E ≤5.0
User's Manual