General Information - Ambu aScope Duodeno Manual Del Usuario

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 care of these medical devices. The IFU may be updated without further notice.
Copies of the latest 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 device 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 device is intended to be used by physicians trained on ERCP procedures. 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 device 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 contact Ambu for support.
1.3. Contraindications
Contraindications for ERCP include the following:
• Patients 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
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