BK Medical bkSpecto 1300, Руководство по обслуживанию

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General Information bkSpecto Ultrasound System
1-2 SM41406-4
1 Introduction
1.1 Safety Aspects
The bkSpecto system complies with:

IEC 60601-1 Edition

ANSI/AAMI EX60601-1:A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012

CSA CAN/CSA-C22.2 NO. 60601-1:14

IEC 60601-2-37:2007

IEC 60601-1-6:2010 (Third edition) + A1:2013

IEC 62304:2006 (All applicable Clauses)
The bkSpecto system is classified as follows:

Array Input Module: Type B (Body) and Type BF (Body Floating)

ECG Input Module: Type BF (Body Floating)
1.2 Terms and Symbols Used
Throughout this manual, the following terms are used to indicate a situation where safety
precautions are required:
Warning: Indicates a situation involving risk of injury or loss of life to personnel or patient.
Caution:
Indicates a situation involving risk of damage to the instrument or other equipment connected.
Symbol Name Description
ATTENTION Consult ACCOMPANYING User Guide when this sign is
encountered on the instrument, to avoid reducing its safety
Potential
Equalisation Terminal connected to the chassis. Should be connected to
corresponding terminals on other equipment to eliminate potential
differences.
Type CF CF: Isolated from earth. Maximum Patient Leakage Current under:
Normal Condition

10

A, Single Fault Condition

50

A
Type BF BF: Isolated from earth. Maximum Patient Leakage Current under:
Normal Condition

100

A, Single Fault Condition

500

A
Type BF BF, DEFIBRILLATOR-PROOF
Type B B: Maximum Patient Leakage Current under: Normal Condition

100

A, Single Fault Condition

500

A
IP57 SEALING Dust and immersion protected according to IEC Publication 529
Stand-by Push button for switching the scanner from stand-by to active. (The
power supply cord is the means of separation from the main power
supply.)
Off Main power supply off
On Main power supply on
Non-ionising
radiation Ultrasound Scanner emits acoustic radiation
STERILE Device is in a sterile condition