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DT_0006 Issue 17
A Global Leader in Respiratory Solutions
of 28
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided (refer to section 2. Contraindications, Warnings, Precautions and
Adverse Reactions).
Note: The EMISSIONS characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
Note: The device may be susceptible when exposed to high levels of electrostatic
discharge. To restore function, press the On/Off switch.
16. FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order of a
physician.
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