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Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
Safety Information
CAUTION: Before using the Ultiri™ Measurement System for the first time, be
sure to read and understand all information in this chapter. Carefully read all
instructions prior to use. Observe all warnings and precautions noted
throughout these instructions; otherwise, complications and / or additional
intervention may occur.
Although the Ultiri Measurement System conforms to both international and
European safety and electromagnetic compatibility standards, the system is
intended for use only by medical personnel who are knowledgeable in physiology
procedures. Only a knowledgeable operator can determine if Ultiri Measurement
System use is appropriate. An awareness of system limitations is essential to
making that determination and ensuring safe operation for both operator and
patient.
This section provides information on:
•
Patient and operator safety
•
Avoiding electrical hazards
•
Wireless communication
•
Electromagnetic interference
Patient and Operator Safety
The Ultiri Measurement System is intended for use only by medical personnel
who are familiar with its operation and skilled in the clinical procedures to be
used.
To avoid any potential hazard to patients, follow the precautions outlined in this
section.
General
WARNING: Failure to follow the guidelines described in these Instructions for
Use and in the Instructions for Use provided with the accessories may result in
injury to patients and damage to equipment.
WARNING: Failure to abide by the precautions detailed below causes the
system and its use to be out of compliance with regulations and places the
patient and the operator at risk of injury or death.
WARNING: Connecting to External Equipment - When used in the patient
environment, all equipment connected to the Ultiri Measurement System must
meet the requirements for medical isolation according to the IEC 60601 safety
standards. Connection of equipment that does not follow relevant IEC standards
(e.g., IEC 60601 series for medical electrical equipment) may lead to patient
injury or death.
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