User guide

Chapter 7: Safety 99
Safety
Electrical safety classification
WARNING:
To prevent injury to the operator/bystander, the transducer must be removed
from patient contact before the application of a high-voltage defibrillation pulse.
WARNING:
To avoid possible electrical shock or electromagnetic interference, verify proper
operation and compliance with relevant safety standards for all equipment before
clinical use. Connecting additional equipment to the ultrasound system constitutes
configuring a medical system. SonoSite recommends verifying that the system, all
combinations of equipment, and accessories connected to the ultrasound system
comply with JACHO installation requirements and/or safety standards such as
AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and electromagnetic
compatibility standard IEC 60601-1-2 (Electromagnetic compatibility), and are
certified according to IEC Standard 60950 (Information Technology Equipment
(ITE)).
Caution:
Do not use the system if an error message appears on the image display: note the
error code; call SonoSite or your local representative; turn off the system by
pressing and holding the power key until the system powers down.
Caution:
To avoid increasing the system and transducer connector temperature, do not
block the airflow to the ventilation holes on the side of the system.
Class I equipment The ultrasound system is classified as Class I equipment when
powered from the external power supply or mounted on the
stand because the external power supply is a Class 1
protectively earthed power supply.
The stand has no protective earth. Ground bond testing is not
applicable to the ultrasound system or the stand.
Note: AC powered peripherals that may be used with the system are Class
I and are individually protectively earthed. Ground bond testing may be
conducted on each AC powered peripheral.
Internally powered
equipment
Ultrasound system not connected to the power supply
(battery only)
Type BF applied parts Ultrasound transducers
Type CF applied parts ECG module/ECG leads
IPX-7 (watertight
equipment)
Ultrasound transducers
IPX-8 (watertight
equipment)
Footswitch