Welch Allyn Connex ECG Module Directions For Use Manual page 15

Directions for use About warnings and cautions 11
WARNING Physiological variations in the patient population generate a
nearly infinite range of possible ECG waveform morphologies. In some
cases, the Connex device occasionally may not alarm or alarm
inappropriately for some arrhythmia (V-Tach, V-Fib and asystole)
waveforms. It is the operator 's responsibility to set alarm limits as
appropriate for each individual patient. High risk patients must be kept
under close surveillance.
WARNING For patients with a pacemaker, maintain a minimum of 6
inches between the device and pacemaker. Power down the ECG module
immediately and provide appropriate patient care if you suspect the ECG
module has affected the pacemaker.
WARNING Patient safety risk. Use of impedance respiration monitoring
can affect the operation of some pacemakers. Keep pacemaker patients
under close observation. If pacemaker operation is affected, turn off
impedance respiration.
WARNING Impedance respiration must be disabled when using ECG wrist
clip electrodes.
WARNING Inaccurate measurement risk. Impedance respiration
monitoring is not reliable when ECG electrodes are placed on the limbs.
WARNING Patient safety risk. Correctly set pacemaker detection and
keep pacemaker patients under close observation. A pacemaker pulse can
be counted as a QRS, which could result in an incorrect heart rate and
failure to detect cardiac arrest and some life-threatening arrhythmias (V-
Tach, V-Fib, and asystole). If your patient has a pacemaker, turn pacemaker
detection ON to avoid this hazard.
WARNING Inaccurate measurement risk. When an external pacemaker is
being used on a patient, arrhythmia monitoring (to detect V-Tach, V-Fib and
asystole) is severely compromised due to the high energy level in the
pacemaker pulse. This may result in the arrhythmia algorithm's failure to
detect pacemaker non-capture or asystole.
WARNING Patient safety risk. Implantable pacemakers, which are minute-
ventilation-rate adaptive, can occasionally interact with the impedance
respiration measurement of cardiac monitors causing the pacemakers to
pace at their maximum. Keep pacemaker patients under close observation.
WARNING Inspect device and accessories before each use. Use only
Welch Allyn approved accessories. Peripheral equipment and accessories
that touch the patient must comply with all appropriate safety, EMC, and
regulatory requirements.
WARNING Frequently inspect—electrically and visually—all cables,
sensors, and electrode wires. Replace any damaged cables, sensors, or
wires. Failure to properly inspect and keep in excellent working order all
cables, sensors, and electrode wires can result in hazards to patients and
to equipment failure and damage.
WARNING Always keep patient motion to a minimum. Motion artifact can
cause inaccurate measurement of patient vital signs.