inventum BDA432 Instruction Manual page 34

• 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 allergic reaction or contact injury.
• Please use the ACCESSORIES and detachable parts specified/authorised by the MANUFACTURER. Otherwise, it may cause damage to
the unit or danger to the user/patients.
• The device doesn't need to be calibrated within two years of reliable service.
• Please dispose of the ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
• To avoid measurement errors, carefully read this manual before using the product.
• Please use the soft cloth to clean the whole unit. Don't use any abrasive or volatile cleaners.
• The device is not intended for patient transport outside a healthcare facility.
• Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and
result in harmful injury to the PATIENT.
• When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of
the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements;
the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is
present; inflating the cuff on the side of a mastectomy.
• 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.
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