¡ Do not use with patients with localized infection, ulceration
or skin lesions involving the wrist.
¡ Do not use with patients that have restricted blood flow
e.g. tourniquet, pressure cuff or IV line.
¡ Do not use with patients with tremors or convulsions.
¡ Do not use with patients with peripheral vascular disease
affecting the hands.
¡ Do not use on an area with a tattoo.
¡ DO NOT use in MRI or a CT environment.
¡ Do not use if there is a known allergy to metals, plastic
and silicon.
4. SAFETY
4.1. Electrical Safety
The device complies with the requirements of AAMI/ANSI/IEC/
EN 60601-1+ED-3 for safety of medical equipment:
Class II equipment type BF applied part.
Mode of operation: spot measurement.
Degree of mobility: portable.
4.2. EMC Compliance
The device complies with the requirements of IEC/EN 60601-1-
2+ED-4 for EMC of medical equipment:
The device has Class BF III compliance.
4.3. Safety Instructions
Warnings:
¡ DO NOT USE BEFORE READING THIS USER MANUAL.
¡ Only apply the device on clean, intact wrist skin.
¡ The device can only measure while the patient is at rest.
¡ This device is not defibrillation proof per IEC60601-1.
¡ Do not use the device in an MR environment or in an
explosive atmosphere, such as in the presence of a
flammable anesthetic.
¡ In case of discomfort, inspect the device sensor application
site to ensure correct sensor alignment and skin integrity.
¡ Avoid excessive pressure to the sensor application site as
this may cause damage to the skin beneath the sensor
(device straps too tight).
¡ Regarding the frequency of sensor relocation and
inspection of application site: The device must be located
on the wrist to activate the device properly. Check the
application site every 4 hours for skin integrity. If there is
any concern, remove the device and replace with another
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