Indication For Use; Contraindications; Intended Use And Usability - CareFusion Vyntus WALK Instrucciones De Uso

Indication for Use

Vyntus WALK is a mobile medical application which is intended to be used on a mobile platform to
collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry
data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform
has access to a host computer with SQL database (SentrySuite) via a wireless network for further
data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing
they can cooperate with the test instructions. Measurements are performed under the direction of
a physician in a hospital environment, physician's office or similar setting (professional healthcare
facilities).

Contraindications

The medical history of the patient should be checked to ensure there are no contraindications to
performing the test.
See the ATS and ERS recommendations for further information:
http://www.thoracic.org/statements/resources/pft/sixminute.pdf

Intended Use and Usability

In order to ensure correct use, this device may only be used by authorized individuals and specially
trained personnel.
Information on Usability:
Ambient requirements:
- Use of the medical product in a medical environment (e.g. doctor's office, clinic, hospital)
- Communication with the patient must be ensured (e.g. eye contact, duty of care)
- Ambient conditions see section "Technical Data"
Operator requirements:
- Operation only by specially trained physicians or medical technicians
- Reading and comprehension of accompanying documents
- Adequate computer skills incl. operating elements
- Communication with the patient and the medical product must be ensured
(use of e.g. visual and acoustic aids recommended)
Patient requirements:
- Adequate patient cooperation is ensured
- Use with patients > 4 years of age is possible
- No restrictions with regard to height, weight and gender
General requirements:
- The patient must not be left unattended during the measurement.
Version 05.00 • 06-06-2017
All manuals and user guides at all-guides.com
Instructions for Use Vyntus WALK
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