Boston Scientific SC-5110 Instrucciones De Uso página 2

Physician Trial Kit
ENGLISH
Physician Trial Kit
SC-5110 External Trial Stimulator
SC-5212 Remote Control
Caution: Federal Law restricts this device to
sale, distribution, and use by or on the order
of a physician.
The Precision Trial Stimulator is intended to
be used during a screening trial to assess
the efficacy of spinal cord stimulation in the
treatment of patients with chronic pain. The
Trial Stimulator communicates with, and is
controlled by, both a patient programmer (the
Remote Control) and a clinician programmer
via a wireless link.
The Remote Control unit is a hand-held
device for patient control of both the
external Trial Stimulator and the permanent,
implantable pulse generator (IPG) models of
the Precision SCS device.
®
Following set up of the Remote Control by
the clinician, the Trial Stimulator is able to
respond to patient control of:
• stimulation on/off functions
• stimulation amplitude and other (optional)
parameters
• stimulation delivery areas
• individualized stimulation therapy
programs.
Patient use instructions are outlined in the
Patient Trial Handbook.
Physician Trial Kit
9055930-005 Rev A 2 of 86
Storage, Handling, and
Transport:
• To avoid unexpected stimulation results,
never make connections while the Trial
Stimulator is on.
• The battery used in the Trial Stimulator
may present a risk of fire or chemical burn
if mistreated. Do not disassemble, heat
above 100 ºC (212 ºF), or incinerate.
• Handle the devices with care. Although
durability testing has been performed
to ensure quality manufacturing and
performance, dropping the devices
on hard surfaces or in water, or other
destructive handling, can cause
permanent damage.
• Avoid all sources of water that can come
into contact with the devices.
• Do not expose the devices to extreme
temperatures.
• Store between -20 and 60 °C (-4 and
140 °F).
• Do not dispose of the devices in fire.
Trial Stimulator
1. 2-R
2. 1-L
3. Indicator Light
4. Stimulation On/Off