beautypg.com

Environmental safety, Declaration of electromagnetic compatibility (emc) – Audioscan Axiom User Manual

Page 6

background image

Axiom

®

User's Guide Version 1.8

May 2015

received, including interference that may cause undesired operation

This Class A digital apparatus complies with Canadian ICES-003

WARNING: To avoid the risk of electric shock, this product must be used only with the power supply
supplied with the product.

WARNING: To avoid the risk of electric shock, this product must be connected only to a supply mains with
protective earth (ground).

WARNING: To avoid the risk of electrical shock, any line-powered peripheral equipment connected to this
product must comply with UL/IEC 60601-1 OR comply with UL or IEC and ISO safety standards for such
equipment AND a) be operated from an isolating transformer complying with UL/IEC 60601-1 OR b) be kept
at least 6 feet (1.8 m) from the patient.
WARNING: This equipment is not suitable for use in an oxygen-rich environment or in the presence of
flammable anesthetic mixtures with air or with oxygen or nitrous oxide.

WARNING: No modification of this equipment is permitted

This symbol on the product is a WARNING that failure to follow instructions in this part of the User’s and/or
Quick Start Guides could place the operator or patient at risk.

This symbol on the product means that the parts applied to the patient meet the safety requirements of IEC
60601-1 for type BF isolated (floating) applied parts

Environmental safety

This symbol on the product means that this product is not to be disposed of in unsorted municipal waste

because electrical and electronic waste may contain hazardous substances which could endanger the
environment and human health.

This product and its associated items must be disposed of in accordance with local disposal regulations for electrical

and electronic waste. Consult your local waste disposal authority regarding applicable regulations.

The microphone probe tubes and the foam eartips used with the RECD transducer are for single patient use. After use,
they may be disposed of in unsorted municipal waste or as required by your facility's waste management policy.

Declaration of Electromagnetic Compatibility (EMC)

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the following information:

The Axiom should not be used adjacent to or stacked on other equipment. If this is necessary, its operation
should be verified as normal in this configuration.

Portable and mobile RF communications equipment can affect medical electrical equipment and may affect
the performance of the Axiom.

Performance degradation due to electromagnetic disturbances (including electrostatic discharge) is
considered normal and acceptable

6