3B Medical Lumin LM3000 Manuale di istruzioni - Pagina 12
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Handle the bulb as a contaminated surface. Don all appropriate PPE when handling a used
bulb.
7. If you have any problems or questions concerning this device, please contact 3B Medical
Technical Support at email:
corporate website at
technical support team is available during normal business hours (i.e. M-F 8:30 am to 5 pm) at
(863) 226-6285.
8. If the device malfunctions, continue with the 5-day minimum interval between reuses, as
per the CDC reuse recommendations. Report any problems immediately to 3B Medical
using the contact information provided above.
Healthcare facilities must report any discoloration or other signs of degradation with a bioburden reduced,
compatible N95 respirator to 3B Medical, and the healthcare facility must discard the respirator. Healthcare
facilities must report adverse events of which they become aware related to the Lumin LM3000 and the
bioburden reduced, compatible N95 respirators. This includes, but is not limited to, monitoring personnel using
the Lumin LM3000 and healthcare personnel using the bioburden reduced, compatible N95 respirators for signs
and symptoms of potential infection with SARS-CoV-2 or other respiratory infection and reporting such infections.
Report Adverse events to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-
1088.
The Lumin LM3000 is warrantied for a period of 2 years from time of purchase to be free from
manufacturer defect or workmanship. Should you encounter a warranty issue please contact 3B
Medical at www.3BLumin.com to submit a return authorization or email [email protected].
It is at the discretion of 3B Medical to repair, replace, or exchange your Lumin LM3000 unit should it be
necessary. 3B Medical is not liable for misuse, mishandling, or breach of this written guarantee. Attempts
to alter the Lumin LM3000 in any way will void the warranty.
www.3Bproducts.com
and creating a support ticket. Alternatively, our
REPORTING
WARRANTY
or by visiting the Support tab on our
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