GE ApexPro TT, Техническое руководство

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1-4 ApexPro™ 2001989-351A
Introduction
Type CF applied part: Isolated (floating) applied part suitable for intentional external and internal application to the patient
including direct cardiac application. “Paddles” outside the box indicate the applied part is defibrillator proof.
[Medical Standard Definition:] F-type applied part (floating/isolated) complying with the specified requirements of IEC
60601-1/UL 60601-1/CSA 601.1 Medical Standards to provide a higher degree of protection against electric shock than
that provided by type BF applied parts.
NOTE
The rating of protection against electric shock (indicated by symbol for CF) is achieved only when used with patient
applied parts recommended by GE.
TYPE B APPLIED PART: Non-isolated applied part suitable for intentional external and internal application to the patient
excluding direct cardiac application.
[Medical Standard Definition:] Applied part complying with the specified requirements of IEC 60601-1/UL 60601-1/CSA
601.1 Medical Standards to provide protection against electric shock, particularly regarding allowable leakage current.
R&TTE equipment class 2 identifier: An alert sign, indicating that transmitting radio equipment operates in non-
harmonized frequency bands and can cause interference.
Equipotential
DC In/RF Out or DC Out/RF In
DC In or RF In
For indoor use only.
Power supply cable configuration.
+ = Power
– = Return
4P41
Medical Equipment
With respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, and CAN/CSA C22.2 NO.
601.1 and if applicable, IEC 60601-2-27, IEC 60601-2-30, and IEC 60601-2-49.
CE mark CE-0459 indicating conformity with the provisions of the Council Directive 93/42/EEC concerning medical
devices, and fulfills the essential requirements of Annex I of this directive.
Interface Connector(s)
INTFC.