VOCARE vitals360, Руководство пользователя

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Instructions for Use Page 6 of 117
DEVICE
The VITALS360 ® device is a professional grade mobile medical device. The device was designed to capture
and display vital sign results to healthcare providers and lay persons in a clinical or home environment. The
device is available only through prescription by a healthcare provider and is intended for spot-checking blood
pressure, pulse, blood oxygen saturation, ECG, respiration rate, heart rate, infrared temperature, weight and
height. The User Manual is a reference that does not substitute for training by a healthcare professional prior
to use. These vital sign measurements can be stored on the device for display or sent by way of a third-party
Medical Device Data System (MDDS) platform. The device natively does not perform any decision support
functions or provide alerts to the user.
The device operates on Android OS® and utilizes a Qualcomm Gobi® chip enabling the VITALS360® device to
connect with most wireless carriers.
There are three modes in which the device can be used: spot-checking in the field, checking vital signs in a
clinical setting and checking vital signs by the patient or lay person in a remote location.
In the first scenario, the healthcare provider takes the device into the field and uses the device as a standard
medical device for spot-checking patient vital signs. In this scenario, patient registration is not required. The
device works completely offline and does not associate any vital sign measurement with patient data. It is up to
the healthcare provider to communicate and, if needed, associate (on other external physical or digital media)
the measured vital signs for a patient. The operating mode corresponding to this scenario is called Single Test
Mode.
In the second scenario, the healthcare provider is in a clinical setting, checking the vital signs of known,
registered outpatients. The measured vital signs are associated with the patient and are stored in a 3
rd party
Class I Medical Device Data System (MDDS). The operating mode corresponding to this scenario is called Multi-
test and Share Mode.