Intended Use; Contraindications; Declaration Of Conformity - John Bunn DigiO2 Operación Manual

s NOTICE: DO NOT subject the oximeter to high temperature or high pressure steam
disinfection. Refer to the REPAIR AND MAINTENANCE/Cleaning and Disinfection
section of this manual for instructions for cleaning and disinfection.

Intended use

The John Bunn DigiO
into one device, is used to measure pulse oxygen saturation (SpO
value, and blood perfusion index (PI) or pulse strength in home or clinical settings.
It is designed for adult and pediatric patients, and fits fingers of thickness .39" - .87"
(10mm - 22mm).

Contraindications

WARNING: DO NOT use the oximeter while the patient is undergoing MRI or CT
scanning.

Declaration of Conformity:

This device complies with the
following standards:
JB02007-INS-LAB-RevC16
Finger Pulse Oximeter, which combines a sensor and monitor
2
IEC 60601-1
ISO 9919
ISO 21647
and follows the provisions of the council directive MDD93/42/EEC
) value, pulse rate
2
6