User's Manual

User Guide
CAUTION -- Investigational device.
Limited by Federal law to investigational use.
Assistance Information
For technical help, please call Podimetrics, Inc.
Phone: [phone]
Email: [e-mail]
Mail: Podimetrics, Inc.
231 R Holland St.
Somerville, MA 02144
Complaints related to device functionality,
performance, or service can be submitted by phone
or email.
Indications for use
The Sole Defender is part of the Podimetrics Remote Temperature
Monitoring System which is intended to be used by a patient for
periodic evaluation of the temperature over the soles of the feet for
signs of inflammation in conjunction with a healthcare professional
or caretaker. It will assist in determining when the patient and
healthcare provider should communicate for further diagnosis and
treatment regarding any persistent localized inflammation
observed on their feet via the electronic sensing system and remote
visualization of its data. The Podimetrics RTM System is for
prescription use only and is intended to be used under the direction
of a healthcare professional as an adjunct to, and not in
replacement of, self-examination and periodic foot care and
examination conducted by a healthcare professional and does not
diagnose any specific disease state.
The Podimetrics RTM System is for daily use in the home or clinic
by people at risk for inflammatory foot diseases.
Contraindications
The Sole Defender mat should not be used by patients with active
ulcers or other lesions that have broken the skin on the plantar
surface of the foot.
TM
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