Proper System Handling - Brainlab Curve Dual Navigation Station System User's Manual

SYSTEM OVERVIEW
2.3

Proper System Handling

Classification
Curve Dual Navigation Station is classified as Class I Equipment according to IEC 60601-1 and
must be tested accordingly.
Classification
Proper Handling
Prior to surgery, test the system to ensure that all components are functioning properly. Do
not use equipment if you suspect that it is damaged in any way.
Only individuals trained by Brainlab may use the system in a clinical environment.
Do not sit or stand on the Monitor Cart or Camera Cart.
Classification - EM Tracking Unit
The EM Tracking unit is classified as Class II Equipment according to IEC 60601-1 and must be
tested accordingly.
Classification
Classification - EM Instrument Ports
The EM instrument ports are classified as Type BF according to IEC 60601-1 and must be tested
accordingly.
Classification
Patient Safety
System components should never come into direct physical contact with the patient.
System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
Definition
Refers to equipment classification regarding protection against electric shock.
Class I Protective means are provided for metallic accessible parts or metallic internal
parts, such as connection to PE (protective earth).
Definition
Refers to equipment in which protection against electric shock does not rely
on basic insulation only, but in which additional safety precautions such as
Class II
double insulation or reinforced insulation are provided, without provision for
protective earthing or reliance upon installation conditions.
Definition
F-Type Applied Part complying with the specified requirements of this stand-
Type BF ard to provide a higher degree of protection against electric shock than that
provided by Type B Applied Parts.
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