Shockwave Medical 825D Manuel D'utilisation page 6

EN
SHOCK HAZARD
This product delivers pulses of up to 3000 volts of electrical energy. Unless properly used as described in these
operating instructions, this electrical energy may cause serious injury.
To avoid the risk of electrical shock, this equipment must only be connected to a grounded electrical outlet
(electrical supply mains with protective earth.) Use with a hospital grade receptacle. Grounding reliability can only
be achieved when connected to an equivalent receptacle marked "hospital use" or "hospital grade". Only use the
Charger Module provided with the Generator to avoid shock.
SHOCK HAZARD
Do not attempt to service the system. It contains no operator serviceable components and dangerous high
voltages may be present. No user modification or servicing of this equipment is allowed. If any part of this product
appears damaged, remove from use and contact your Shockwave Medical representative for repair or
replacement.
SHOCK OR FIRE HAZARD
Do not immerse any portion of the Generator in water or other fluids. Do not immerse Connector Cables in water
or other fluids. Avoid spilling any fluids on the Generator. Spilled liquids may cause the Generator to perform
inaccurately or malfunction.
Do not clean with solvents or flammable agents as this may cause damage to the Generator and possibly cause
harm to the user.
Do not autoclave or sterilize the Generator or Connector Cables as this may cause the Generator or Connector
Cable to malfunction.
POSSIBLE FIRE
Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing).
Turn off gas source or move source away from patient during therapy.
ELECTRICAL INTERFERENCE HAZARDS
Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI)
which could affect the performance of this device. If use of equipment in close proximity is necessary, observe the
device to verify normal operation in the configuration in which the device will be used.
Do not operate the Generator near cauterizers, diathermy equipment, or other portable and mobile RF
communications equipment. Refer to Appendix A for recommended distances of equipment. Contact your
Shockwave Medical representative if assistance is required.
POSSIBLE ELECTRICAL INTERFERENCE
Using cables, emitters, or accessories not specified for use with this product may result in increased emissions
and/or decreased immunity from electromagnetic or radio frequency interference (RFI) which could affect the
performance of this product or of equipment in close proximity. Use only parts and accessories specified in these
operating instructions.
POSSIBLE DEVICE SHUTDOWN
This device operates only from an internal battery source. Charge the Generator battery when not in use.
Available battery capacity is indicated on the Generator front panel display as a battery symbol that is filled in solid
proportionate to charge status. A lightning bolt symbol is displayed inside the battery symbol during charging. The
Generator may shut down without warning if the Generator is operated while the battery symbol is empty (no
portion filled in).
Remove the Generator from use and contact your Shockwave Medical representative in the event the displayed
battery symbol is frequently empty or if the battery symbol is not full after twelve hours of charging.
SAFETY RISK AND POSSIBLE EQUIPMENT DAMAGE / POSSIBLE INJURY OR SKIN BURNS
The Generator and its accessories (including Lithoplasty Catheters and Connector Cables) contain ferromagnetic
materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high
magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI
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