ZOLL EMV+ - Electrical Safety Testing Warnings

Electrical Safety Testing
906-0731-04-01 Rev. C ZOLL Ventilator Service Manual 5–2
is a Class 1 medical device, certified to IEC 60601-1 with BF applied parts.
The ZOLL 731 series ventilators have been certified as Class 1 ME externally powered per IEC/EN 60601-1
Standards.
The device meets the class 1 standard when operating on battery as the device is internally powered, and
again when operating on AC due to the presence of a protective earth connection.
The design of these products comply with IEC standards, which allow for various methods of protection.
Subclause 8.6 of IEC 60601-1 states the following:
"Typically, metal ACCESSIBLE PARTS of CLASS I ME EQUIPMENT are PROTECTIVELY EARTHED. However, they
could be separated by other MEANS OF PROTECTION, in accordance with 8.5."
Subclause 8.5.1 details the following example:
"PATIENT CONNECTIONS and other ACCESSIBLE PARTS are separated from parts different from earth potential
by DOUBLE or REINFORCED INSULATION."
731 Series ventilators comply with Subclause 8.5.1 as the external power supply is double insulated, and
therefore provides protection to the entire rest of the system. Further, an isolation transformer within the
external power supply also provides a reduction in voltage from the AC input to 24Vdc.
Per the standard, a protective earth connection is not required to be carried through to the chassis. Any
exposed metal components on the chassis, are not to be considered protective. Exposed metal components in
the chassis of the ventilator can however be used for enclosure leakage measurements or “Touch current”
testing.
Warnings:
Electrical safety testing should NOT be performed in or around ESD testing areas.
ESD protocols (methods) should NOT be enforced during electrical safety testing, since they could cause a
hazardous condition for equipment and test operators.
• A electrical safety testing device generates voltages and currents that can cause harmful or fatal electric
shock and must only be operated by a skilled worker trained in its use.
• DO NOT wear an ESD wrist strap. ESD protocols (methods) should NOT be followed when electrical safety
testing.
• Before and after testing, handle test clips by insulation only, never touch clips directly.
• Do NOT touch the ventilator, the electrical safety testing device, high voltage test lead, alligator clip, or clip
insulator once testing starts.
WARNING:
Electrical safety testing produces voltages and currents that can cause harmful or fatal electric shock.
To prevent accidental injury or death, safety procedures must be strictly observed when handling and
using the electrical safety testing device.