Turning On The Rezūm Generator; To Turn On - Boston Scientific Rezum Manuel D'utilisation

Caution: Observe the following cautions when connecting this generator with
other equipment:
• Ensure that the connected equipment is in accordance with the IEC60601-1 or IEC
safety standards.
• Employ additional protective measures (e.g., additional protective earthing)
as necessary.
Caution: Exposing the Rezūm™ Generator to extreme environmental conditions outside
of its normal conditions may compromise the ability of the Rezūm Generator to function
properly and/or cause the plastic to warp and/or crack.
Caution: The Rezūm Generator power cord and delivery device cable may cause a trip
hazard while attached to the generator.
Caution: If the Rezūm Generator is stored in an environment with a temperature below
the operating temperature, the unit should be allowed to warm up to the needed
operating temperature before using.
Caution: Equipment operating in close proximity may emit strong electromagnetic
or radio frequency interference (RFI), which could affect the performance of this
device. Avoid operating the Rezūm Generator near cauterizers, diathermy equipment,
FM 2-way radios, or cellular phones. Turn power off to radio, cellular and other like
equipment near the Rezūm Generator. Refer to the EMI tables.
Caution: The Rezūm Generator is intended to be used indoors at a medical facility or
physician office environment only.
Connecting the Power Cord
Warning: Do not connect to an electrical outlet controlled by a wall switch because
the generator may be accidentally turned off.
Warning: Do not plug power cord into an outlet (or unplug it) with wet hands.
Warning: Use only specified power cord.
Warning: To avoid the risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.
Warning: A protective ground connection by way of the grounding conductor in the
power cord is essential for safe operation. To avoid electrical shock, plug the power
cord into a properly wired receptacle, use only the power cord supplied with the
generator, and make sure the power cord is in good condition.
Warning: Use a grounded AC outlet for the power supply and ground this generator.
Warning: Use only approved and specified parts, accessories, optional parts,
consumables, and components.
Warning: Use with the specified AC voltage and frequency.
• Make sure that the AC outlet is properly grounded and supplies the specified
voltage and frequency.
• Connect the female connector end of the power cord to the AC power connector on
the back of the generator.
• Plug the male connector end of the power cord into a properly grounded
AC power outlet.
Turning on the Rezūm Generator
Danger: Do not take or use the device in locations where combustible anesthetics or
flammable gases are used or in high-pressure oxygen rooms or inside oxygen tents.
Warning: The Rezūm Generator is reusable but is restricted to a single patient at a
time for a therapy session.
Caution: If there is condensation on the generator, dry it thoroughly before turning the
power on.
Caution: When any of the following occur, turn the power off, remove all accessories
from the patient, and unplug the power cord from the outlet.
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• If you think the generator may have been damaged.

To Turn On:

1. Open the lid of the generator to show the display screen and make sure it is fully open.
2. Turn on the generator by pushing the top of the Power button located on the front of
the generator as depicted in Figure 6.
Black (K) ∆E ≤5.0
I
O
Figure 6: Power Button
3. While the generator is powering up, it initially displays two start-up screens and a
test screen.
Warning: In the event of power failure, the generator will automatically shut off. Turn
the power button off. Please remove the Delivery Device from the patient immediately
per instructions in the DFU. Turn on again to restart the generator to begin a new
therapy session.
Figure 7: Start-up Screens
Figure 8: Test Screen
4. It will automatically run the Start-up Diagnostics. During this time the test screen is
displayed, and a bar and text will indicate status of the tests on the screen.
5. After the Start-up Diagnostics are completed, the generator will display the Delivery
Device Setup screen.
8
Power
Button