Important Information — Please Read Before Use
3
VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
User qualifications
If there is an official standard of the qualification of endoscopy and endoscopic
treatment that is defined by the medical administration or other official
institutions such as the academic society of endoscopy, follow the standard. If
there is no official qualification standard, the operator of this instrument must be
a physician approved by the medical safety manager of the hospital or person in
charge of the department (department of otorhinolaryngology, etc.). The medical
safety manager of the hospital or person in charge of the department should
select a physician who is performing the planned endoscopy and endoscopic
treatment safely by following the official guidelines set by the academic society
of endoscopy, etc., and considering the difficulty of each type of endoscopy and
endoscopic treatment.
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient and operator injury and/or equipment damage.
This instrument complies with the EMC standard for medical electrical
equipment, edition 4 (IEC 60601-1-2: 2014).
When connecting to an instrument that complies with a previous edition of the
EMC standard for medical electrical equipment edition, the EMC characteristics
could be vulnerable.
Reprocessing before the first use/reprocessing and
storage after use
This instrument was not cleaned, disinfected or sterilized before shipment.
Before using this instrument for the first time, reprocess it according to the
instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter
7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic
Instruments”.
After using this instrument, reprocess and store it according to the instructions
given in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage,
Transporting Outside the Hospital and Disposal”. Improper and/or incomplete
reprocessing or storage can present an infection-control risk, cause equipment
damage or reduce performance.