ZONARE Z.ONE PRO - Standards and Compliance

z.one
pro
Service Manual
Page 27 of 217
P4-1c .......................(I.D. 6)
 Penetration Depth 30 cm
 Number of Elements 64
 Field of View 84 degrees
 Ultrasound Bandwidth 4-1 MHz
A2CW .....................(I.D. 514)
 Number of Elements 2
 Ultrasound Frequency 2.0MHz
 Ultrasound Bandwidth n/a
A5CW .....................(I.D. 513)
 Number of Elements 2
 Ultrasound Frequency 5.0MHz
 Ultrasound Bandwidth n/a
P8-TEE ...................(I.D. 8)
 Penetration Depth 8 cm
 Number of Elements 64
 Ultrasound Bandwidth 8-3 MHz
Standards and Compliance
The z.one
pro
system has been designed, manufactured, tested, and certified to comply with the following
internationally recognized standards.
IEC 60601-1:1988 +A1: 1991 + A2:1995: Medical electrical equipment part 1: General requirements for safety.
IEC 60601-2-37:2001+A1: 2004 + A2:2005: Medical electrical equipment part -37: Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment.
IEC 60601-1:2005: Medical electrical equipment part 1: General requirements for basic safety and essential
performance. Including US deviations UL 60601-1:2003 R6.03 and Canada deviations CAN/CSA-22.2 No.
601.1-M90
IEC 60601-1-2: 2007: Medical electrical equipment part 1-2: General requirements for basic safety and
essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-37:2007: Medical electrical equipment part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment.