28
29
Warning: Do not apply the cuff over a wound; otherwise it can cause further injury.
Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around
simultaneously, because this could cause temporary loss of function of those simultaneously-used
monitoring ME equipment.
On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the
cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 15mmHg
for more than 3 minutes) applied to the arm may lead to an ecchymosis.
Please check that operation of the device does not result in prolonged impairment of patient blood
circulation.
When measurement, please avoid compression or restriction of the connection tubing.
The device cannot be used with HF surgical equipment at the same time.
The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated
according to the requirements of ISO 81060-2:2013.
To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing
inaccurate readings, the effects of this device on the fetus are unknown.
Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise,
the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
When not in use, store the device with the adapter in a dry room and protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
This device may be used only for the purpose described in this booklet. The manufacturer cannot be held
liable for damage caused by incorrect application.
This device comprises sensitive components and must be treated with caution. Observe the storage and
operating conditions described in this booklet.
The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or nitrous oxide.
Warning: No servicing/maintenance while the ME equipment is in use.
The patient is an intended operator.
The patient can measure data and change battery under normal circumstances and maintain the device
and its accessories according to the user manual.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment.
If you are allergic to polyester, nylon or plastic, please don’t use this device.
During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any
potential sensitization or irritation reaction.
Adaptor is specified as a part of ME EQUIPMENT.
If you experience discomfort during a measurement, such as pain in the arm or other complaints, press
the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from
your arm.
If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not