Chapter 1 Safety 1 - 7
Electrical Safety
This equipment is categorized as a Class I device with Type BF or Type CF (ECG) applied parts.
Prevention of Electric Shock
In a hospital environment, dangerous electric current may occur as a result of the potential
difference between a contactable conductive part and connected equipment in treatment rooms.
The solution to the problem is consistent equipotential bonding. Medical equipment is connected
with connecting leads made up of sockets which are angled to the equipotential bonding
network in medical rooms.
[Figure 1.1 Equipotential Bonding]
Additional equipment connected to medical electrical equipment must comply with the pertinent
IEC standards (e.g. IEC 60950/EN 60950 for data processing equipment, IEC 60601-1/EN
60601-1 for medical devices). Furthermore, all components of the product shall comply with the
requirements for medical electrical systems IEC 60601-1-1/EN 60601-1-1. Any person
connecting additional equipment to the signal input and output ports of medical electrical
equipment must verify that the equipment complies with IEC 60601-1-1/EN 60601-1-1.
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