Safety & Compliance

Solace Cold/Heat Compression Device

Safety information, precautions, and compliance standards for professional healthcare use.

General Safety Information

The Solace Cold/Heat Compression Device is designed for use in professional healthcare settings. The device should be used in accordance with the instructions for use provided by the manufacturer and under the direction or supervision of a healthcare provider.

Warnings & Precautions

For use on intact skin only
Not intended for use on areas with compromised skin integrity
Discontinue use if pain, discomfort, or adverse reaction occurs
Use only accessories supplied or specified by the manufacturer
For indoor use only

Electrical & Environmental Safety

Use only the power adapter supplied by the manufacturer
Do not expose the device to excessive moisture
Do not disassemble the device
Store and operate the device within recommended environmental conditions

Standards & Compliance

The Solace Cold/Heat Compression Device is designed and manufactured to meet applicable safety and electromagnetic compatibility standards.

IEC 60601-1 (Medical Electrical Equipment — General Requirements)
IEC 60601-1-2 (Electromagnetic Compatibility)
Electromagnetic compatibility compliance

Adverse Event Reporting

Healthcare providers are encouraged to report any serious adverse events associated with the use of this device in accordance with applicable regulatory requirements, including FDA MedWatch reporting procedures.