OCULUS BIOM 6 Bedienungsanleitung

BIOM ® 6 HD Optic Set
Instructions for Use
Scope of Delivery
BIOM®6 HD Optic Set for f=175mm (Box of 4 units)
BIOM®6 HD Optic Set for f=200mm (Box of 4 units)
Contents (of 1 unit):
(1) Sterility Cover, Top
(1) Sterility Cover, Bottom
(1) Lens Module
Indications for Use:
Allows non-contact visualization of the ocular fundus, vitreous and retinal structures during vitreoretinal surgery.
Performance Characteristics:
This optic set provides a two part disposable sterility cover for the OCULUS BIOM
module with an integrated wide field lens providing a high resolution view of the entire fundus and far periphery. The
sterility cover included in REF 10029900 is designed to fit the OCULUS BIOM
in REF 10029902 is designed to fit the OCULUS BIOM
Intended use:
For use with the OCULUS BIOM ® 6 wide-angle viewing system in conjunction with compatible surgical microscopes in
hospitals, surgery centers, clinics, and other medical institutions.
Contraindications:
There are no known contraindications, undesirable side effects, or specific patient population.
Warning:
•
To be used only by a licensed physician in a method consistent with other wide-angle surgical ophthalmic
lenses.
•
Never use a product that appears to be damaged. Do not use if the packaging is open, damaged, or
expired.
• Product is for single use only. Reuse, reprocessing, or resterilization may create a risk of contamination
and/or cause patient infection or cross-infection, including but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness,
or death of the patient.
• In any serious incident contact manufacturer and your local competent authority.
• Do not assemble or disassemble while the microscope is positioned over the patient
Directions:
Non-sterile personnel
1. Visually inspect pouch for damage and check expiration date. Product must not be used if any breaches of
the packaging integrity or other obvious damage is found or if expiration date has passed.
2. After completed check, peel open pouch without touching inner contents.
3. Let contents slide onto sterile surface or aseptically present to sterile operating nurse. Make sure not to
contaminate contents during this process.
4. Position BIOM ® 6 focusing module to operating position.
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REF 10029900
REF 10029902
® 6 viewing system and a lens
®
6 for f=175mm and the cover included
® 6 for f=200mm.
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Sterile operating nurse/surgtech
5. Carefully remove sterility covers from clamshell packaging, and lens module from blister insert.
6. Push lower cover onto metal focusing unit (FIGURE 1). Hold by sterile cover and swing focusing module to
standby position. Align top cover using tab and press the snaps into place, only touching within the
indicated safe zones (FIGURE 2). Verify that covers are secured into position and that all snaps are fully
engaged.
7. Hold lens module by large outer diameter and insert into lower opening of focusing unit (FIGURE 3). Push
to engage snap features and verify that lens module is secured.
8. Adjust microscope focus to proper position on exterior of eye. Refer to BIOM 6 User Manual for detailed
focusing instructions.
9. Move focusing unit into operating position by lifting the two tabs on lens module (FIGURE 4a) and
swinging into optical path of the microscope (FIGURE 4b).
WARNING: DO NOT RELEASE LENS MODULE WHEN IN CLOSE PROXIMITY TO THE PATIENT. UNCONTROLLED
RELEASE OF SPRING CAN RESULT IN EYE INJURY.
10. To swing focusing unit out of operating position, first retract lens module by lifting the two tabs.
11. After use, first remove optics module by depressing the two release tabs (FIGURE 5). Then remove top
cover and lower cover by firmly grasping the pull tab and pulling away from the device until cover
seperates along tear-line (FIGURE 6).
Sterilization:
These items are delivered in a sterile condition and are for SINGLE USE ONLY. After surgery, they should be properly
disposed of according to contaminated medical waste guidelines of your facility.
Contents sterile if package is not expired, opened, damaged or wet.
UI-54029.860 R1 ECN-2608
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Date of issue 2025-11-14
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