Centauri Medical Inc. 1116AG Manuale Utente
Centauri Medical, Inc.
Document No. 1312AJ
DynaSense Instructions For Use
Page 9 of 54
INDICATIONS FOR USE
DynaSense monitors orientation and activity of patients susceptible to
pressure ulcers. It allows healthcare providers to implement individualized
turn management plans and continuously monitor each patient.
DynaSense provides alerts when patient orientation or activity deviates
from parameters set by healthcare providers. The device is intended for
use in medical, nursing and long-term care facilities including independent
living, assisted living and rehabilitation facilities.
DynaSense is not intended as a substitute for vital signs monitoring or
alerting equipment, or for professional judgment, and is not intended to
provide automated treatment decisions.
CONTRAINDICATIONS
•
DynaSense is contraindicated for patients who have a pacemaker or an
implantable cardioverter-defibrillator (ICD).
•
Wearing the Patient Sensor is contraindicated for patients undergoing X-
ray, CT, MRI, and the use of any technology exposing the Patient
Sensor to high levels of ionizing radiation. The Patient Sensor should be
removed before these types of procedures are performed.
Sensor to high levels of ionizing radiation. The Patient Sensor should be
removed before these types of procedures are performed.
•
DynaSense is contraindicated for patients with a known tape allergy or
sensitivity to EKG leads or similar types of adhesives used in common
medical products.
medical products.
•
DynaSense has not been tested on women who are pregnant or
breastfeeding, so the risks to unborn fetuses and nursing children are
unknown. As such, all women who are pregnant, planning on becoming
pregnant, or are currently breastfeeding should not receive the
DynaSense Patient Sensor.
unknown. As such, all women who are pregnant, planning on becoming
pregnant, or are currently breastfeeding should not receive the
DynaSense Patient Sensor.