User's Manual

Polytel
®
Data Transmission System
8-1500-R - 14 -
WARNING: “Modifications made to the product, unless expressly approved
by Polymap Wireless, LLC could void the user’s license for and the warranty of the
device.”
CAUTION: Risk of explosion if battery is replaced by an incorrect type.
Dispose of used batteries according to the instructions.
5.2 Electrical Safety
Only authorized maintenance staff may remove the covers from the PWR-08-03 Remote
Device. Always refer servicing to Polymap Wireless-authorized personnel.
The Polytel® Data Transmission System is classified as CLASS II equipment as per
IEC60601-1 and Class II Medical Devices per 21CFR. There are no patient connected
parts in the Polytel® Data Transmission System. The Host Medical Devices are approved
for use by their respective manufacturers and agencies monitoring them. Polymap
Wireless is not responsible for their diagnostic accuracy or their electrical safety. There are
no special provisions to protect the system from flammable anesthetics or ingress of liquids
WARNING! Never operate this device in zones where there is a risk of
explosion. Electrical equipment used in the presence of flammable anesthetics or
oxygen may cause an explosion.
5.3 Compliance Information
This section details the telemetry system compliance requirements and the manufacturer’s
responsibilities.
5.3.1 Compliance Requirements
The manufacturer is responsible for the effects of safety, reliability, and performance of
this equipment with the following provisions:
• The equipment is used in accordance with instructions for use
• Assembly operations, extensions, modifications, or repairs are performed by
authorized persons only.
5.3.2 Compliance Statement
The manufacturer states that this device conforms to:
• FDA 21 CFR Parts 820
• IEC 60601-1: Medical Electrical Equipment – General Requirements for Safety.
• IEC 60601-1-1: Medical Electrical Equipment – Collateral standard: Safety
requirements for medical electrical systems
• IEC 60601-1-2: Medical Electrical Equipment – Collateral standard:
Electromagnetic compatibility for medical electrical systems