Sonicaid Team Operator’s Manual
6
Standards compliance
Sonicaid Team complies with:
EN60601-1: 1990 Medical Electrical Equipment Part 1
General Requirements for Safety
EN60601-1-1: 1993 Safety Requirements for Medical Electrical Systems
[collateral standard]
EN60601-1-2: 1993 Medical Electrical Equipment Part 1. General require-
ments for safety Section 1.2 Collateral standard: Electro-
magnetic compatibility – Requirements and tests.
EN61157: 1995 Requirements for the declaration of the acoustic output
[IEC61157:1992] of medical diagnostic ultrasonic equipment.
Notes
Some features on the Team monitor have not been approved for sale in the USA and
Canada. The following features are therefore not available on Team monitors sold in
those countries:
z Maternal ECG
z Rimkus Telemetry
z Use of Team with GMT Argus central review
z Sonicaid Trend analysis
In addition, for FECG the use of FDA-compliant fetal scalp electrodes is required in
the USA and Canada.
Patient safety
WARNING: DO NOT TOUCH LIVE PARTS OF ANY EQUIPMENT (eg COM PORT
CONNECTOR PINS ON A PC) AND THE PATIENT AT THE SAME TIME.
CE Mark
Denotes conformity with the European Council
Directive 93/42/EEC concerning medical devices.
THIS FETAL MONITORING SYSTEM IS A PRESCRIPTION DEVICE IN THE USA.
To Next Page
Loading...
