Essential Performance; Warning - B.O.L.T BT4 User Manual

B.O.L.T User Manual
 The user must follow the regulations specified in the below warnings, cautions and
Care & maintenance.
5.1

Essential Performance

The ability to detect noninvasive blood pressure (NIBP) as per IEC 80601-2-30, noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) as per ISO 80601-
2-61, and body temperature (TEMP) as per ISO 80601-2-56 & ASTM E1965-98 (2016) .
5.2

Warning

 All users should read the user manual thoroughly. An electronic version of the current
copy of this manual can be obtained from the official website.
 Read the Intended use, Warnings and Cautions carefully before the use of the
product.
 All modifications and repairs to the B.O.L.T devices should be carried out by
authorized service personnel or their agents.
 Do not plug or unplug the AC adapter with wet hands.
 Do not clean the device while the power is ON.
 Use of the devices are restricted to one patient at a time.
 Highly recommended to use manufacturer supplied power adapter and USB cable for
charging the B.O.L.T base unit.
 Keep the B.O.L.T devices out of reach of infants, children, or pets, since inhalation or
swallowing of small parts is dangerous or even fatal.
 If you encounter any problem while taking blood pressure measurement, such as
inflation does not stop or air leakage in the cuff, remove the cuff or pull out the air
tube from the base unit.
 Do not wrap the cuff around the arm where an intravenous injection or transfusion is
being given to the patient.
 Do not operate the B.O.L.T device in places where inflammable gas, such as highly
inflammable anesthetic, may be generated or in a high-pressure oxygen room or in an
oxygen tent.
 Keep the B.O.L.T device away from infants, small children or anyone who is incapable
of using the device in a correct manner.
 Do not use the device for a cardio-pulmonary bypass patient.
 Do not use the device in an MRI suite.
 The B.O.L.T device is not suitable for use on pregnant women, patients with an
implanted electrical device, patients with preeclampsia, premature ventricular beats,
atrial fibrillation, peripheral arterial disease, and patients undergoing intravascular
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