Rx Only
5 of 36
4260-MAN-000-V
Additional notes:
A FLASHING RED indicator means that stimulation has been
requested, but adequate stimulus current is NOT being delivered
because of poor connection of the probe or the needle return
electrode to the patient tissue.
o
Check needle return electrode contact and position.
o
Check probe contact and position.
o
Move probe to a position with a known response.
Moving the stimulus amplitude switch to the OFF/Standby
position or moving the pulse duration slider to 0 μs will stop
stimulation and the visual indicator will be illuminated YELLOW
continuously.
End of use / disposal:
A low (depleted) battery will cause the Stimulator to automatically
turn off and the visual indicator will not be illuminated. No further
use of the Stimulator will be possible.
At end of use, move the stimulus amplitude switch to the
OFF/Standby position and move the pulse duration slider to the
minimum position (0µs).
Cut off and dispose of needle electrode in appropriate sharps /
biohazard container.
Product is powered by two size N alkaline cells in series
permanently sealed within the device. Use appropriate disposal
methods per hospital guidelines.
INDICATOR LIGHT STATUS:
LIGHT
STIMULUS STATUS
Solid
yellow
The Stimulator is ON but stimulation is NOT being
delivered (the amplitude and/or pulse duration is set to
zero).
Flashing
yellow
Stimulation is being delivered (NOTE: the flashing
rate does NOT correspond to the stimulus frequency
or intensity).
Flashing
red
Stimulation has been requested, but adequate stimulus
current is NOT being delivered because of poor
connection of the probe or the needle return electrode
to the patient tissue.
WARRANTY and LIMITATIONS:
Checkpoint Surgical, Inc. (CPS) warrants that this product has been
manufactured, packaged, and tested with reasonable care and will be free
from defects in workmanship and materials. CPS further warrants that
the product will remain sterile for a period described on the product’s
label, provided the original packaging remains intact. This product is for
single-use only and is not intended or designed for reuse. This warranty
shall not apply to product that has been re-sterilized, repaired, altered, or
modified in any way, or to products that have been improperly stored or
operated. CPS will not be liable for any incidental, special or
consequential loss, damage, or expense resulting, directly or indirectly,
from the use of the product. The sole obligation of CPS shall be to refund
or replace, at its option, any device that CPS determines was defective at
time of shipment if notice thereof is received before expiration date
described on such product label. Buyer assumes all liability, whether
based upon warranty, contract, negligence, or otherwise, for damage
resulting from the handling, possession, use or misuse (including reuse)
of this product. Because CPS has no control over the operation,
inspection, maintenance, or use of its products after sale and has no
control over selection of patients, THIS WARRANTY IS EXPRESSLY
IN LIEU OF ANY OTHER EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF
THE SELLER. The remedies set forth in the Warranty and Limitations
shall be the exclusive remedy available to any person. No agent,
employee, or representative of CPS has any authority to change any of
the foregoing or assume or bind CPS to any additional liability or
responsibility in connection with this warranty. Buyer’s use of this
product shall be deemed acceptance of the terms and conditions of this
Warranty and Limitations.
