Country-specific information and labels
000000-1865-713-GA-en-US-080622
Country-specific information and
labels
Classification/Manufacturer's declaration
WARNING – GENERAL HAZARDS
This device may only be set up, operated and used for the specified
purpose and according to national regulations, consistent with the
applicable industry standards and occupational safety and accident
prevention regulations. Further notes on classification are to be found in
section
Technical data, page 31 and following.
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
The product is RoHS-compliant according to Directive 2011/65/EU.
Option Reference Image purpose
The Option Reference Image may only be used in conjunction with the
IOLMaster 500 and is intended for use as a preoperative and postoperative
image capture tool.
The user is liable for any use of the device other than intended.
Side effects and contraindications
The Option Reference Image should not be used on patients with rotational
nystagmus.
Intended user profile
CAUTION - RISK OF OPERATING ERRORS
Federal law restricts this device to sale by or on the order of a physician or
practitioner.
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