Safety Information; Warnings, Subject Safety; Cautions - FINAPRES Finometer Model-2 User Manual

2

Safety information

2.1

Warnings, subject safety

• The data produced by Finometer® Model-2 or the accompanying
software is intended as an adjunct in subject assessment and
should not be used as a sole means for determining a subject's
diagnosis.
• Finometer® Model-2 is a finger blood pressure monitor. Never use
the finger cuffs on other parts of the body.
• Finometer® Model-2 can only be used in persons aged over 18
years.
• To maintain designed operator and subject safety only use
accessories such as finger cuffs provided by Finapres Medical
Systems B.V.
• Federal (USA) law restricts this device to sale by or on the order of
a physician.
• Finometer® Model-2 is class B equipment according to EN 60601-
1. Use the Finometer® Model-2 only with a properly grounded AC
receptacle.
• To maintain designed operator and subject safety, peripheral
equipment that is connected to Finometer® Model-2 or one of its
components, shall comply with the relevant standards.
2.2

Cautions

• MRI compatibility: To prevent damage to the device, do not use
Finometer® Model-2 during Magnetic Resonance Imaging (MRI)
scanning. The cuff pressure control valve inside the frontend unit is
electromagnetically driven and cannot operate within the strong
magnetic field.
• To prevent possible damage to the keys do not use sharp or hard
objects to press the keys, only use fingertips.
• Never clean the device or one of its components by submersing it
into a liquid. Follow the cleaning instructions in this User's Guide.
Finometer® Model-2 23
User's Guide