1.
Important Information – Please Read Before Use!
Read this Instructions For Use (IFU) carefully before using the aScope™ Duodeno and keep for future
reference. Failure to read and thoroughly understand the information presented in this IFU, as well
as those developed for ancillary endoscopic equipment and accessories, may result in serious injury
to the patient and/or user. Furthermore, failure to follow the instructions in this IFU may result in
damage to, and/or malfunction of, the equipment.
This IFU describes the recommended procedures for inspecting and preparing the system prior
to its use. It does not describe how an actual procedure is to be performed, nor does it attempt
to teach the beginner the proper technique or any medical aspects regarding the use of the
equipment. It is the responsibility of each medical facility to ensure that only appropriately trained
personnel, who are competent and knowledgeable about endoscopic equipment, antimicrobial
agents/processes and hospital infection control protocol are involved in the use, handling and the
care of these medical devices. The IFU may be updated without further notice. Copies of the current
version are available upon request.
1.1
Intended Use / Indication For Use
The aScope™ Duodeno is designed to be used with the aBox™ Duodeno, endoscopic
accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor)
for endoscopy and endoscopic surgery within the duodenum.
Note:
Do not use this instrument for any purpose other than its intended use. Select the
endoscope to be used according to the objective of the intended procedure based on the full
understanding of the endoscope’s specifications and functionality as described in this IFU.
1.2
General Information
The operators of the system are physicians trained in diagnostic and therapeutic GI Endoscopy. If there
are official standards for user qualifications to perform endoscopy and endoscopic treatment that
are defined by the hospital´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
hospital or person in charge of the department (department of internal medicine, etc.).
The physician should be capable of safely performing 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.
Additional equipment connected to medical electrical equipment must comply with the respective
IEC or ISO standards (e.g. IEC 60950 or IEC 62368 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical systems (see clause 16
of the latest valid version of IEC 60601-1). Anybody connecting additional equipment to medical
electrical equipment configures a medical system and is therefore responsible that the system
complies with the requirements for medical electrical systems. If in doubt, consult your local
representative or the technical service department.
1.3
Contraindications
Contraindications for ERCP include the following:
•
Patiens under 18 years.
•
When the risks to patient health or life are judged to outweigh the most favorable benefits
of the procedure.
•
When adequate patient cooperation or consent cannot be obtained.
•
When a perforated viscus is known or suspected.
Additional contraindications could exist for high risk procedures such as biliary sphincterotomy in a
patient who is fully anticoagulated with Coumadin or therapeutically dosed with clopidogrel.
Following conditions may as well contraindicate ERCP and need to be qualified:
•
patient has suffered a prior severe allergic reaction to ERCP contrast medium
•
unstable cardiopulmonary, neurologic or cardiovascular status of the patient
•
severe uncorrected coagulopathy
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