Warnings
3
Page 6
Connection with other
devices
Additional equipment connected to the analogue and digital interfaces of
the PC must demonstrably meet its corresponding EN specifications (e.g.
EN 60950 for data-processing devices and EN 60601 for electromedical
devices). In addition, all configurations must satisfy the system standard
VDE 0750 part 1-1. Devices may only be connected to each other or with
parts of systems if it is ensured that the safety for the patient, the user and
the environment is not impacted by this coupling.
Provided that safe coupling is not readily apparent from the device data, the
user must determine, by contacting the respective manufacturers or
inquiring with a qualified person, that the necessary safety for the patient,
the user and the environment is not impaired by the intended coupling.
Standard IEC 601-1-1 / EN 60601-1-1 must be complied with in any case.
Only the original blood pressure cuff and the fibre optic connection cable
from Zimmer MedizinSysteme may be used.
The use of components which are not included in the scope of delivery or
not approved by Zimmer MedizinSysteme for PremoPort
Four
may lead to
measurement errors and malfunctions.
Hazards to persons
The device should never be connected to a PC or other devices while it is
still placed on the patient.
PremoPort
Four
should not be used if any of the contraindications applies
(see chapter “Background medical information / Contraindications”).
The device should also not be used for patients without a corresponding
indication for ambulatory blood pressure monitoring.
Information about blood
pressure measurement
Prior to each use of the PremoPort
Four
, the user must ascertain its
functional safety and proper operating condition.
Ensure that air circulation in the cuff and in the tube are not obstructed
since this can lead to circulation problems with serious injury to the patient.
The pressure tube should never be knotted, compressed or pulled apart
between PremoPort
Four
and the cuff.
Ensure that neither the cuff nor the connection tube nor the connection
cable leads to strangulation or circulation problems.
If blood pressure measurements cause bruises, dizziness or pain in the
arm, the cuff should be removed from the arm and disconnected from the
recorder. Events of this type should be reported to the physician no later
than after the monitoring.
If the patient should experience dizziness or pain in the arm after ending a
blood pressure measurement, the cuff should be removed to avoid
permanent vascular or neural injuries.
A physician should always be consulted for the interpretation of blood
pressure measurements. Be aware that any blood pressure measurement
can be affected by the patient’s body position, physiological constitution or
other factors.
Overly frequent measurements can cause injury to the patient due to
circulation problems.
Never place the cuff over a wound since it can cause further injury.
Be aware that the placement and inflation of the cuff on any body part with
intravascular access or intravascular therapy or arteriovenous (AV) shunt
can lead to injury to the patient due to occasional interruption of blood flow.
The cuff should not be placed and inflated on the arm on the side of a
mastectomy.
Check (for example, by observing the affected extremity) that operation of
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