GE eBike with Control Terminal PC, Operator'S Manual

Page: 44 / 172

Intended Use, Safety Information
8 eBike with Control Terminal PC 2018112-001 Revision B
Special NIBP Safety Instructions
Applicable laws, regulations and directives
– 93/42/EEC (Medical Device Directive of the EU)
– 89/336/EEC (Electromagnetic Compatibility
Directive of the EU)
– EN 1060-1 Non-invasive sphygmomanometers, Part
1: General requirements
– EN 1060-3 Non-invasive sphygmomanometers, Part
3: Supplementary requirements for electro-
mechanical blood pressure measuring systems
Warning
Patient Hazard —
– Do not use a cuff to take blood-pressure
measurements on patients suffering from sickle
cell anemia or where skin lesions are likely to
occur.
– The cuff may cause hematomas in patients with
severe blood coagulation disease. In these
instances, the user must take a decision for or
against automatic blood-pressure
measurements.
Caution
Compromised Measuring Accuracy —
– Arrhythmias occurring frequently during a
measurement may compromise the accuracy of
the measuring values. In certain cases, a valid
measurement will not be possible.
– Electromagnetic fields may also impair the
measuring accuracy.
Note
– The blood-pressure module and the approved
accessories are defibrillation-proof and can
remain attached to the patient during
defibrillation.
– If the cuff pressure exceeds the maximum value
of 300 mmHg during inflation, the inflation
procedure will be aborted and the cuff deflated.
As a redundant safety precaution, the cuff is
immediately deflated when the cuff pressure
exceeds 320 mmHg.
You can check the proper functioning of this
safety precaution by abruptly bending your arm
while the cuff is being inflated, causing a brief
overpressure in the cuff. The cuff must
immediately deflate.
– Measurements that do not yield a valid
measurement will not be repeated during the
exercise test.
– If the inflation phase takes longer than 40
seconds or if an adequate pressure does not
build up in the cuff within a reasonable period
of time, the measurement will be aborted and
the cuff will deflate.
– If a valid measurement cannot be completed
within 120 seconds, the measurement will be
aborted and the cuff will deflate.
– If the cuff pressure remains constant for some
time, the measurement will also be aborted and
the cuff will deflate.