Welch Allyn CP 100 Update To Directions For Use page 9

Feature updates prior to the 2.6 software release
Connecting the Patient Cable
Insert all leads into their proper positions, as labeled on the connectors. See
"Inserting the
Figure 4. Inserting the Leads
Updated Information for the CP 100/CP 200
Heart rate monitor operation
The heart rate indicated on the CP 100 or CP 200 LCD display is for reference only. Make
manual measurements of the ECG intervals and magnitudes on printed ECG reports only.
The increased R wave amplitudes that are produced by some patient simulators may
produce heart rate readings two times higher than normal because the R waves can be
counted as T waves.
The CP 100 and CP 200 devices are not intended to be used as heart rate monitors. Heart
rate monitors are covered by other standards for example: ANSI/AAMI standard EC13:
Cardiac monitors, heart rate meters and alarms.
Artifact
A combination of abnormally large R wave amplitude and waveform shapes delivered by
some patient simulators can trigger artifact warnings. These warnings are not consistent
with actual patient morphologies. The noise warning is designed as a guide to limit low
quality ECGs.
The CP 100 and CP 200 devices are compliant to all applicable standards specified in the
device manual for diagnostic electrocardiographs including: IEC/EN 60601-2-51 and ANSI/
AAMI EC11.
Reducing Artifact
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Leads".
Use only resting tab electrodes that have not past their product expiration date.
Store only in an air tight pouch within the product recommended environmental
conditions.
When using the reusable bulbs, limb plates, or clamp electrodes, always replace
expired or dried up electrode gel.
When using the reusable bulbs, limb plates, or clamp electrodes, use only an
ECG conductive gel to obtain optimum conductivity. Do not use ultrasound gel.
Orient the adapter (alligator) clips so that the metal from the clip is able to make
contact with the conductive area of the resting tab electrode.
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Figure 4