Important Information — Please Read Before Use
FLUSHING PUMP OFP-2
6
Clinical benefits
The clinical benefit of the device lies in its functionality as described by its
intended purpose.
Contact
Manufacturer
KeyMed (Medical and Industrial Equipment) LTD
KeyMed House, Stock Road,
Southend-on-Sea, Essex SS2 5QH
United Kingdom
www.olympus.com
concerns@olympus.co.uk
Incident reporting
European Union
If a serious incident occurs with the device, report it to the manufacturer and the
relevant national authority.
Eurasian Economic Union
If a serious incident occurs with the device, report it to the manufacturer and the
relevant national authority.
Other regions
If a serious incident occurs with the device, report it to the manufacturer and/or
the relevant national authority according to national legislation.
Applicability of endoscopy and endoscopic treatment
If there is an official standard on the applicability of endoscopy and endoscopic
treatment that is defined by the hospital’s administration or other official
institutions such as academic societies on endoscopy, follow that standard.
Before starting endoscopy and endoscopic treatment, thoroughly evaluate its
properties, purposes, effects, and possible risks (their natures, extent and
probability). Perform endoscopy and endoscopic treatment only when its
potential benefits are greater than its risks.
Fully explain to the patient the potential benefits and risks of the endoscopy and
endoscopic treatment as well as any examination/treatment methods that can be
performed in its place, and perform the endoscopy and endoscopic treatment
only after obtaining the consent of the patient.
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