Subscribe to Our Youtube Channel
Related Manuals for Ambu aBox Duodeno
Summary of Contents for Ambu aBox Duodeno
- Page 1 Instruction For Use Ambu® aBox™ Duodeno For use by trained clinicians/physicians only. For in-hospital use. For use with Ambu® aScope™ Duodeno.
- Page 2 20kg HD-SDI 1 HD-SDI 2 Trig-1, -2, -3 aScope Duodeno aScope Duodeno 1... 2... 3... Ambu is a registered trademark and aBox™ Duodeno is a trademark of Ambu A/S.
-
Page 3: Table Of Contents
5.4 Control Panel Navigation Ending A Procedure And Shutting Down The System 6.1 Concluding A Patient Procedure System Shutdown Fuse Replacement Peristaltic Pump Replacement Cleaning Of The aBox™ Duodeno External Surfaces 10. Technical Data 10.1 aBox™ Duodeno Specifications 10.2 Storage And Operation Environment Specifications 10.3 Accessories 10.4 List Of Accessories-Examination 11. Environmental Protection 12. Troubleshooting 12.1 Returning The aBox™ Duodeno To Ambu 12.2 Compliance And Licensing 12.3 Electromagnetic Compatibility Contact Appendix1. Connection Configurations Descriptions Appendix2. WPF-Mediakit... -
Page 4: Important Information - Please Read Before Use
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... - Page 5 Connect only medical grade equipment to the aBox™ Duodeno. • Never use the aBox™ Duodeno if an abnormality is suspected. Damage or irregularity in the device may compromise patient and/or user safety and may result in more severe equipment damage. • Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the aBox™ Duodeno immediately and contact Ambu. Do not prepare, inspect or use the aBox™ Duodeno with wet hands. • In case of instrument failure or malfunction, always keep another aBox™ Duodeno in the room ready for use. • Never insert or spray anything into the ventilation grills of the aBox™ Duodeno. It can cause an electric shock and/or fire. •...
- Page 6 • If any other abnormality occurs or is suspected, immediately stop using the equipment, turn OFF all equipment, and gently withdraw the endoscope from the patient as described in the endoscope's instruction manual. Then refer to the instructions in section 12, troub- leshooting. If the problems cannot be resolved by the remedial action described in section 12, do not use the equipment and contact Ambu. • Clean the device and change gloves prior to touch the device and between cases. No changes of gloves could lead to a cross-contamination. Ancillary Equipment •...
- Page 7 Installation, Repair and Maintenance • The device contains no parts that can be repaired by the user. Any disassembling, change or attempt to repair can lead to injury of patient or user and damage of the system. Installation, repairs and maintenance must be performed by Ambu staff or Ambu approved staff. Please read section 12. for more information regarding troubleshooting. Cautions Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. General •...
-
Page 8: System Description
When the device is used with energized endoscopic devices, leakage current may be additive. Use only endoscopic devices of type BF or CF. Check the compatibility of the accessory/endoscopic device before use to any criteria for safe use. System Description System Parts The aBox™ Duodeno is reusable. No modification of this equipment is allowed. The aBox™ Duodeno is shipped with one power cable that supplies the power necessary to run the aBox™ Duodeno, a bottle holder for the sterile water bottle and a potential equalization cable (POAG). Ambu® aBox™ Duodeno Part number Reusable Device 485001000US Bottle Holder... -
Page 9: Compatible Device (Application Part)
Power Cable POAG Cable The aBox™ Duodeno is not available in all countries. Please contact your local sales office. Compatible Device (Application Part) Ambu® aScope™ Duodeno Part number Distal End Working Outer Channel Sterile and single-use device Diameter ø Inner Diameter ø 482001000 41.2 Fr 12.6 Fr (13.7 mm) (4.2 mm) The aScope™ Duodeno is not available in all countries. For detailed information please contact your local sales office. aBox™ Duodeno Description And Function The aBox™ Duodeno is the console that is necessary for processing the endoscope camera´s video image, the remote switches and output video and recorder data. The aBox™ Duodeno is designed to be used with the aScope™ Duodeno. Part Function... -
Page 10: Explanation Of Symbols Used
Part Function Power button with power indicator Press button for power ON before procedure and power OFF after procedure. The button will light up green when turned ON. Main fuse Device protection Main switch Switch button for power ON and power OFF AC power inlet AC power cord socket POAG socket Socket for potential equalization... -
Page 11: Ancillary Equipment And Accessories
Ancillary Equipment And Accessories • The following ancillary equipment must be connected for the system to become functional and for recording patient data. Inspect the following equipment as described in their respective instruction manuals. • Bottle holder (part of the system) • Sterile water for rinsing equal to or greater than 1000ml in volume. It is recommended that the bottle of sterile water be placed in the designed bottle holder on the left side of the aBox™ Duodeno. For detailed information regarding attaching the bottle holder to the aBox™ Duodeno please refer to the section 4.1 below. • Medical Grade monitor with resolution at least 1920x1080 and a monitor size of at least • 27" with DVI or HD-SDI input(s). Recommended color space is sRGB. • Image Capture Report and/or writing workstation • Vacuum source at least -7psi (-50kPa) with suction system • Insufflation source approved for use in G.I. endoscopic procedures Attaching The Bottle Holder To The aBox™ Duodeno The aBox™ Duodeno ships with one bottle holder that must be attached to the left side of the device. Follow the illustrations below to properly attach the bottle holder. Ambu® aBox™ Duodeno Bottle Holder aBox Bottleholder - Assembly... -
Page 12: Preparation And Inspection For Use
Preparation And Inspection For Use Numbers in gray circles below refer to illustrations on page 2. Inspect all ancillary equipment to be used with this instrument as instructed in their respective instruction for use manuals. Should any irregularity be observed after inspection, follow the instructions as described in section 12, Troubleshooting. If this instrument malfunctions, do not use it. Contact your Ambu sales repre- sentative for further assistance. • Inspect the contents of the aBox™ Duodeno. Match all items in the package with the components shown in the device description in section 2. • If the device is damaged, a component is missing or you have any questions, do not use the instrument, immediately contact Ambu. • It is recommended that the aBox™ Duodeno to be placed on level surfaces with the capability of movement (i.e. mobile cart, medical equipment booms) such that the system... -
Page 13: Control Panel Navigation
and connect the CO2 and the vacuum source as indicated. Once the connections have beed made, you can perform the functional check of the endoscope. To confirm please press the button on the control panel of the aBox™ Duodeno. After confirmation the aBox™ Duodeno will display the live image on the main monitor screen. Press the light source button for light. Control Panel Navigation The settings and information menu can be displayed by pressing any button on the control panel of the aBox™ Duodeno. Explanation of control panel buttons Button Name Function Light source button Turns the aScope™ Duodeno LEDs ON and OFF Navigate to the left. The left button is used to hide Left button informations and settings menu Right button Navigate to the right Up button Navigate upwards Down button Navigate downwards... -
Page 14: Ending A Procedure And Shutting Down The System
Remote switches 2 . Open the menu by pressing any button on the control panel and select remote switches. The available function for each remote switch will be displayed when entering the settings in a pull-down submenu. Set the desired function for each remote switch and save. • To exit the information and settings menu use the left button . Press once to exit the setting and twice to close the menu. •... -
Page 15: Fuse Replacement
Fuse Replacement Always use the fuses recommended by Ambu. To order new fuses please contact your sales representative. Make sure that only appropiately trained personnel are in charge of the fuse replacement. Turn the aBox™ Duodeno OFF and disconnect the power cable from the walls mains outlet. -
Page 16: Technical Data
Procedure -SUPER- SANI-CLOTH® from PDI or equivalent Use a wipe to remove heavy soil. All blood and other body fluids must be thoroughly cleaned from all surfaces and objects before using germicidal wipe. The treated surfaces must remain visibly wet for a full two (2) minutes. Use additional wipes if needed to assure continuous 2 minutes wet contact time. Let the aBox™ Duodeno air dry. Technical Data All the following reported measurements (e.g. weight, dimensions) are average values. Therefore, small variations may occur, which however have no effect on the performance and safety of the system. 10.1 aBox™ Duodeno Specifications Power Supply Voltage AC 120V / 230V Frequency 50 / 60Hz Consumption electric power 91 VA Fuse rating 2x 5A H 250V T Fuse size 5mm x 20mm Size of the aBox™ Duodeno Dimensions 494 (D) x 487 (W) x 145 (H) mm Weight 13 kg Classification (medical Type of protection against Protection Class I electrical equipment) electric shock IP Classification IP21 10.2 Storage And Operation Environment Specifications Transportation temperature... -
Page 17: Environmental Protection
The following table shows the possible causes of and countermeasures against troubles that may occur due to equipment setting errors or deterioration of aBox™ Duodeno. Troubles or failures other than those listed in the following table need repair. As repair performed by persons who are not qualified by Ambu could cause patient or user injury and/or equipment damage, be sure to contact Ambu for repair. Irregularity Description Possible Cause Solution The power switch and/or the Set the power switch to ON. - Page 18 Irregularity Description Possible Cause Solution aScope™ Duodeno still Please unplug the aScope™ connected Duodeno from the aBox™ Duodeno and press the power button for 3 secs. to shut down the system. aBox™ Duodeno will not Power button was pressed Press the power button for at shut down too short least 3 sec. aBox™ Duodeno defect Switch the aBox™ Duodeno off by using the mains switch on the back panel of the aBox™...
- Page 19 Irregularity Description Possible Cause Solution The medical grade monitor Adjust the color setting at the settings are improper monitor according its IFU, starting from standard color setting (D65). The color tone of the endo- The monitor cable is con- Connect the monitor cable scopic image is unusual nected incorrectly properly as described in Section 5. The medical grade monitor Connect a new power cable to cable is defect the medical grade monitor.
-
Page 20: Returning The Abox™ Duodeno To Ambu
12.1 Returning The aBox™ Duodeno To Ambu Should it be necessary to return an aBox™ Duodeno to Ambu for investigation, please contact your Ambu representative beforehand for instructions and/or guidance. To prevent infection, it is strictly forbidden to ship contaminated medical devices. Hence, the aBox™ Duodeno must be decontaminated on site before shipment to Ambu. Ambu reserves the right to return contamina- ted medical devices to the sender. In an event of a serious incident, please inform Ambu and the competent authority. 12.2 Compliance And Licensing The system conforms to the standard of IEC 60601–1 / ANSI/AAMI ES60601-1, IEC 60601–1–2 and IEC 60601–2–18. 12.3 Electromagnetic Compatibility General Information Medical electrical equipment is subject to special precautions with respect to EMC and must be installed according to the instructions in the accompanying documentation. The manufacturer can only guarantee compliance of the equipment if the accessory parts listed in the accompanying documentation are used. - Page 21 Table 2 Electromagnetic Compatibility 1 Guidelines and manufacturer’s declaration – resistance to electromagnetic interference The aScope™ Duodeno is intended for operation in the electromagnetic environment specified below. The user of the aScope™ Duodeno should ensure that it is used in such an environment. Electromagnetic IEC 60601 test level Compliance level Electromagnetic compatibility testing Environment Guidelines Electrostatic dischar- ± 8 kV contact ± 8 kV contact Floors should be ge (ESD) according to discharge discharge wood or concrete or IEC 61000 – 4 – 2 covered with ceramic ± 15 kV air discharge ± 15 kV air discharge tiles. If the floor is a synthetic material, the relative humidity must be at least 30%. Fast transient ± 2 kV for power ± 2 kV for power lines The quality of the electric interference...
- Page 22 Table 3 Electromagnetic Compatibility 2 Line-conducted HF 3 V;AM/1 kHz/ Portable and mobile coupling according to radio equipment 80%150 KHz – 80 IEC 61000 – 4 – 6 should not be used closer to the unit, Electromagnetic including cords, fields according to 3V/m; than the recom- 3 V/m IEC 61000 – 4 – 3 mended safety 80 MHz – 2.7 GHz distance calculated according to the formula appropriate to the transmission frequency: d=3.5/3 √P up to 80MHz...
-
Page 23: Contact
Warning: This device is intended only for use by trained medical personnel. This is a Class A device according to CISPR 11. In a residential area, this unit can cause radio inter- ference, so it is necessary in this case to take suitable corrective measures, such as readjusting it, rearran- ging it, or shielding the unit or filtering its power connection. Contact Manufacturer Ambu A/S Baltorpbakken 13 2750 Ballerup, Denmark... -
Page 24: Appendix1. Connection Configurations Descriptions
Appendix1. Connection Configurations Descriptions The aBox™ Duodeno is equipped with multiple video outputs for viewing by clinicians and several options for documentation via additional video outputs and a remote signal (i.e. “trigger”) to activate common recording devices. The steps in this appendix will guide the installer through the various available connections and the required cabling for each configuration. Connecting the Mandatory Main Primary Imaging Monitor using the HD-SDI 1 Video Signal Connecting the Optional Secondary Imaging Monitor using the HD-SDI 2 or DVI Video Signal Connection of an Image Capture / Report Writing Workstation using the HD-SDI 2 or DVI Video Signal and TRIG 3 Connection of a Digital Video Recorder using the HD-SDI 2 or the DVI Video Signal and TRIG 1 and/or TRIG 2... -
Page 25: Appendix2. Wpf-Mediakit
Appendix2. WPF-Mediakit WPF-Mediakit is an open source library. It provides a control for Visual Studio .NET to display video from a Windwos imaging device. https://github.com/Sascha-L/WPF-MediaKit/wiki Version: 2.2.0 Release Date: 2017-01-19 Microsoft Public License (Ms-PL) This license governs use of the accompanying software. If you use the software, you accept this license. If you do not accept the license, do not use the software. 1. Definitions The terms "reproduce," "reproduction," "derivative works," and "distribution" have the same meaning here as under U.S. copyright law. A "contribution" is the original software, or any additions or changes to the software. A "contributor" is any person that distributes its contribution under this license. "Licensed patents" are a contributor's patent claims that read directly on its contribution. 2. Grant of Rights (A) Copyright Grant- Subject to the terms of this license, including the license conditions and li- mitations in section 3, each contributor grants you a non-exclusive, worldwide, royalty-free co- pyright license to reproduce its contribution, prepare derivative works of its contribution, and distribute its contribution or any derivative works that you create. - Page 26 Manufacturer: Ambu A/S Baltorpbakken 13, DK-2750 Ballerup, Denmark +45 72 25 20 00 +45 72 25 20 50 www.ambu.com...
Need help?
Do you have a question about the aBox Duodeno and is the answer not in the manual?
Questions and answers