Infinity M300/M300+ Indications for use/Intended use
8 Supplement – Infinity M300 and M300+ Series – VG2.4
Environment of Use
The device is intended to be used in an environment where patient care is provided by Healthcare
Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will
determine when use of the device is indicated, based upon their professional assessment of the patient's
medical condition.
Patient Population
The Infinity M300/M300+ is intended for use with ambulatory and non-ambulatory adult and pediatric
patients, (one patient at a time) excluding infants and neonates, in environments where patient care is
provided by healthcare professionals.
Open-source software
Dräger devices that use software may use open-source software, depending on their setup. Open-source
software may be subject to different terms of license. Additional information regarding the open-source
software used in this device is available at the following web page:
www.draeger.com/opensource
NOTE
Clinical judgement must be used to determine when the M300/M300+ should be used on a specific
pediatric patient. Assigning a specific weight or age to ECG performance is not practical as there are
multiple factors to be considered when making a determination for patient care.
To Next Page
Loading...
