Ambu aBox Duodeno Instrucciones De Uso página 4

1. Important Information – Please Read Before Use!
Read this Instructions for Use (IFU) before operating 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 equipment
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 the
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.
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 grade electrical
systems (see clause 16 of the latest valid version of IEC 60601-1). Anybody connecting additional
equipment to medical grade electrical equipment which 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.
US federal law restricts this device for sale only by, or on the order of, a physician.
1.1. Intended Use / Indication for Use
The aBox™ Duodeno is designed to be used with the aScope™ Duodeno, 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. Target User Groups and User Qualifications
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 (e.g. 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.
1.3. Contraindications
Contraindications depend on the endoscope used and the endoscopic procedure. For detailed
information regarding contraindications please refer to the IFU of the aScope™ Duodeno.
1.4. Installation and Maintenance
The medical devices described in this IFU must be tested/inspected in accordance with
national regulations during installation and regular inspection. The medical device does not
require regular maintenance.
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