User Qualifications; Instrument Compatibility; Reprocessing Before The First Use/Reprocessing And Storage After Use - Olympus EVIS EXERA II Instructions Manual

User qualifications

Instrument compatibility

Reprocessing before the first use/reprocessing and
storage after use
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
If there are official standards for user qualifications for performing endoscopy
and endoscopic treatment that are defined by the healthcare facility's medical
administrators or other official institutions, such as academic societies on
endoscopy, follow those standards. If there are no official qualification standards,
the operator of this instrument must be a physician approved by the medical
safety manager of the healthcare facility or person in charge of the department
(department of internal medicine, etc.).
The physician should be the planned endoscopy and endoscopic treatment
following guidelines set by the academic societies on endoscopy, etc., and
considering the difficulty of endoscopy and endoscopic treatment. This manual
does not explain or discuss endoscopic procedures.
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 or 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.
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 7, "Cleaning, Disinfection, and Sterilization
Procedures".
After using this instrument, reprocess and store it according to the instructions
given in the endoscope's companion reprocessing manual. Improper and/or
incomplete reprocessing or storage can present an infection control risk, cause
equipment damage, or reduce performance.
The balloons are disposable, and are intended for a single use only; a new one
must be used for each patient. Do not attempt to reuse or resterilize a balloon.
Important Information — Please Read Before Use
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