Rayner RayOne Bedienungsanleitung Seite 6

Warnings
• RayOne cannot be reused, as it is not designed to perform as intended after the
first and only usage. Changes in mechanical, physical or chemical characteristics,
under conditions of repeated use, cleaning and resterilisation, will compromise
the integrity of the device.
• Healthcare professionals considering lens implantation under any of the
following circumstances should weigh the potential risk/benefit ratio:
- Recurrent ocular disease (e.g. uveitis, diabetic retinopathy, glaucoma,
corneal decompensation)
- Previous ocular surgery
- Vitreous loss
- Iris atrophy
- Severe aniseikonia
- Ocular haemorrhage
- Macular degeneration
- Zonular dehiscence (for patients at risk of zonular dehiscence,
it is recommended that a capsular tension ring (CTR) is inserted to support
the capsular bag).
- Ruptured posterior capsule
- Patients in whom the intraocular lens may affect the ability to observe,
diagnose or treat posterior segment diseases.
- Surgical difficulties at the time of cataract extraction which might increase the
potential for complications (e.g. persistent bleeding, significant iris damage,
uncontrolled positive pressure or significant vitreous prolapse or loss).
- A distorted eye due to previous trauma or developmental defect in which
appropriate support of the IOL is not possible.
- Circumstances that would result in damage to the endothelium
during implantation.
- Suspected microbial infection
• Non-toothed, polished instruments must be used if handling the IOL.
• Do not allow the IOL to dehydrate during the procedure.
• Do not use balanced salt solution (saline) as the sole lubricating agent,
always use in combination with an ophthalmic viscosurgical device (OVD).
• Do not attempt to disassemble, modify or alter this device or any of its
components, as this can significantly affect the function and/or structural
integrity of the design.
Precautions
• The sterility of the contents is guaranteed only if the outer tray has not
been opened or damaged.
• Do not use if the pack has been damaged.
• Do not store in direct sunlight.
• Do not store the pack outside of the recommended storage conditions;
store between 5°C to 35°C.
• Do not store below 20% Relative Humidity.
• Do not use after the expiry date.
• Do not attempt to reuse this device.
• Do not resterilise.
• Do not use system at temperature below 21°C (equili bration takes
approximately 90 minutes from an initial temperature of 0°C).
Sterilisation and Packaging
The IOL is supplied sterile and preloaded in the RayOne delivery system within
a sterilised blister pack. The sterilised blister pack is steam sterilised and should
only be opened under sterile conditions. An implant card is included in the pack to
record all implant information (the supplied labels may be used). It shall be given to
the patient, with the instruction to keep this card. The card should be shown to any
eye care professional the patient visits in future.