Gima 35145, User Manual

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7
SAFETY
1.1 Safety Information
The safety statements presented in this chapter refer to the basic safety information that the operator of the
monitor must pay attention to and abide by. There are additional safety statements in other chapters or sec-
tions, which may be the same as or similar to the following, or specific to the operations.

Warning:
indicates a potential hazard or unsafe practice that, if not avoided, could result in death or seri-
ous injury.

Caution: indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal
injury or product/property damage.
☞
Note:
provides application tips or other useful information to ensure that you get the most from your prod-
uct.
1.1.1 Warnings

WARNING for PACEMAKER PATIENTS: Although the pacemaker pulse inhibition function is available in
this device, the heart rate meter may continue to count the pacemaker rate during occurrences of cardiac
arrest or some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep pacemaker patients un-
der close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this
instrument.

Disconnect the monitor and sensors from the patient before MRI scanning. Using them during MRI could
cause burns or adversely affect the MRI image or the monitor’s accuracy.

If uncertain about the accuracy of any measurement, firstly check the patient’s vital signs by any alterna-
tive means, and then make sure the monitor is functioning properly.

The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with
clinical signs and symptoms.

Monitor a single person at a time.

The monitor is defibrillation-proof. Verify that the accessories can function safely and normally and the
monitor is grounded properly before conducting defibrillation.

The monitor is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or
nitrous oxide.

Each time the monitor is used, check the alarm limits to ensure that they are appropriate for the patient
being monitored.

The alarm limit value shall be within the measuring range, or it may disable the alarm system. Please refer
to the related chapter for alarm limit range.

A HAZARD can exist if different alarm presets are used for the same or similar device in a single area.

Do not silence the audible alarm if patient safety may be compromised.

The monitor is prohibited from applying to those who have severe hemorrhagic tendency or who are with
sickle cell disease for they may develop partial bleeding when this monitor is used to take the blood pres-
sure measurement.

All the connecting cables and tubes of the applying parts should be kept away from the patient’s neck to
prevent any possible suffocation of the patient.

To prevent the risk of the short circuit and to ensure the ECG signal quality, the device must be properly
grounded.

The device should be considered an early warning device as a trend towards patient deoxygenation is
indicated, blood samples should be analyzed by a laboratory CO-oximeter to completely understand the
patient’s condition.

Although biocompatibility tests have been performed on all the applied parts, some exceptional allergic
patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis.

Please peruse the relative content about the clinical restrictions and contraindication.

It is recommended that the clinical operator regularly test the device and accessories. The visual and au-
ditory alarm signal can be checked by disconnect accessories or by setting it at Demo mode to simulate
alarm event.

Do not allow service or maintenance on the device whilst being used on a patient.
1.1.2 Cautions

All the parts of the monitor should NOT be replaced at will, substitution of a component different from that
supplied by the manufacturer might result in measurement error. If necessary, please use the components
provided by the manufacturer or those that are of the same model and standards as the accessories along
with the monitor which are provided by the same factory, otherwise, negative effects concerning safety and
biocompatibility etc. may be caused. No modification of this device is allowed.

The accessories which can be used repeatedly should be cleaned thoroughly before use on another pa-
tient. Please refer to the related chapter for maintenance method.