Warning And Caution Definitions; Warnings - Zeiss CIRRUS HD-OCT 500 User Manual

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Warning and Caution Definitions

Warnings

2660021169012 Rev. A 2017-12
Warning and Caution Definitions
Certification mark of CSA – Nationally recognized test laboratory for US and Canada
Disposal of the Product within the E.U. Do not dispose via domestic waste disposal system or
communal waste disposal facility.
Caution: Federal law (or United States) restricts this device to sale by or on the order of a licensed
healthcare practitioner
The terms WARNING and CAUTION and the symbol designating each are defined as
follows.
WARNING: Indicates hazards that, if not avoided, may cause severe injury or death.
CAUTION: Indicates hazards that, if not avoided, may result in minor or moderate injury,
or damage to or impaired performance of equipment.
WARNING: To prevent electric shock, the instrument must be plugged into an earth
grounded outlet. Do not remove or disable the ground pin. Only an authorized Zeiss service
representative may install the instrument.
WARNING: Do not open the instrument covers. (Exception: You may remove the rear cover
to access labels and connectors.) Opening the instrument covers could expose you to
electrical and optical hazards.
WARNING: To maintain patient safety, if the instrument is externally connected to non–
medical peripheral devices (i.e., printer, storage devices, etc.), the complete system must
comply with the system requirements in standard IEC 60601–1. This standard requires the
usage of an Isolation Transformer to power the non–medical peripheral device(s) if located
within 1.5 m from the patient. If the peripheral device is located outside the patient
environment (beyond 1.5 m) and is connected to the instrument, a separation device must
be used or there shall be no electrical connection between the non–medical peripheral
device and the instrument.
WARNING: The person or the responsible organization connecting additional devices or
reconfiguring the system must evaluate the complete system to ensure compliance to the
applicable IEC 60601–1 requirements.
WARNING: The instrument operator must not attempt to touch the patient and the
peripheral device simultaneously.
CIRRUS HD-OCT User Manual