________________________________________________________________________________________________________________________________
TensioMed® Arteriograph24™
9
The device cannot be repaired during use. Disassembly or modification of the device is
not
permitted!
Please refer to section 1.3. The manufacturer does not accept any liability for damage or malfunction
in the event of non-compliance.
Avoid fluid contact and/or strong physical effect on the device.
The pressurized cuff can cause loss of signals of other medical devices used on the same arm.
Do not connect the device to a computer network, use it only with the computer you installed the
user software on! Else an „Access violation” error will occur.
Patient safety
The device has an integrated safety mechanism, which prevents the cuff pressure to exceed 300
mmHg. If, however, the inflation continues above this value or the pressurization lasts too long,
unplug the pneumatic connector of the cuff from the device and remove the cuff from the subject.
Too frequent or too long measuring periods might cause blood flow disturbances in the arm. Ensure
by the proper programming of the device enough time for blood flow recovery.
Avoid the kinking of the hose during measurement.
Do not use the device on an arm, which is being injected with intravenous injection.
Do not use the device on patients suffering from blood coagulation disturbances.
In case if the patient had surgical operation on any artery/vein of his/her arm (e.g. arterio-venous
shunt) or permanent/temporary intra-arterial catheter has been installed, do not use this arm for the
measurement.
If the patient had a radical mastectomy, the cuff should not be installed on the same arm, where the
operation was performed.
In case of any skin disease, any inflammation or any wound on the arm, the cuff should be installed
onto the intact arm. If both arms are involved, the physician must decide, assessing whether the
benefit gained by the examination is superior compared to the risk of the measurements.
The Arteriograph24™ device can be used on pregnant women, as well. However, the validation of BP
measurements of the device has not been done on preeclamptic patients, yet.
Do not use the device on neonates or infants! Cannot be used on persons below 3 years of age!
