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Instructions for use

®
Ambu
aScope™
For Single Patient use only – Sterile
For use by trained clinicians/physicians only. For in-hospital use.
®
aScope™ Monitor
Ambu
For use by trained clinicians/physicians only. For in-hospital use.

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Summary of Contents for Ambu aScope

  • Page 1: Instructions For Use

    Instructions for use ® Ambu aScope™ For Single Patient use only – Sterile For use by trained clinicians/physicians only. For in-hospital use. ® aScope™ Monitor Ambu For use by trained clinicians/physicians only. For in-hospital use.
  • Page 2 +39 039 657811 www.ambu.com Fax: +39 039 6898177 www.ambu.it Germany Spain Ambu GmbH In der Hub 5 Firma Ambu S.L. D-61231 Bad Nauheim C/ Alcalá 261-265, Edificio 1, 3º Izq Tlf. +49 6032 92500 28027 Madrid Fax. +49 800 ambude Tlf.
  • Page 3: Table Of Contents

    Warranty and replacement program......................18 Ambu® is a registered trademark of Ambu A/S, Denmark. Ambu is certified according to ISO 9001 and ISO 13485.
  • Page 4: Warning, Precautions And Notes

    • Total lifetime of the Ambu® aScope™ is 8 hours from first switching on. • Operating time of the Ambu® aScope™ is 30 minutes from switching on. Pay attention to the red symbol (less than 5 minutes left) on the Ambu®...
  • Page 5: Intended Use

    The Ambu® aScope™ achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu® aScope™ is in the human anatomy. The flexible tip of the Ambu® aScope™ allows the user to guide the ETT in the desired direction.
  • Page 6: Contraindications

    The system is not to be used when delivering highly flammable anaesthetic gasses to the patient such as a Cyclopropane. This could potentially cause patient injury In case of massive bleeding in the airway do not use Ambu® aScope™. 5. Explanation of symbols used...
  • Page 7: Standards Applied

    (WEEE). Only applicable for the Monitor. Li-ion Battery type Lithium ion. Only applicable for the battery inside the Ambu® aScope™ Monitor Re-chargeable battery. Only applicable for the battery inside the Ambu® aScope™ Monitor Tested to comply with FCC Standards- Medical Equipment 6.
  • Page 8: Technical Product Specifications

    30 ~ 85% Storage Temperature 10 ~ 40°C (50 ~ 104°F) Relative humidity 30 ~ 85% Sterilisation Method of sterilisation Table 1 - Specification for the Ambu® aScope™ Ambu® aScope™ Monitor Dimensions Width 196mm (7.76”) Height 160mm (6.30”) Thickness 142mm (5.60”) Weight 1150g (2.5lbs)
  • Page 9 Fixture Mounting interface 75mm (2.96”) Fits poles with thicknesses 10mm ~ 45mm (0.4 ~ 1.8”) Table 2 - Specification for the Ambu® aScope™ Monitor Ambu® aScope™ power supply Dimensions Weight 245g (0.54lbs) Electrical power Power requirement 100 - 240V AC;...
  • Page 10: Ambu® Ascope™ Functions

    The Ambu® aScope™ system will prevent reuse of the Ambu® aScope™. The Ambu® aScope™ can be used/switched on for a total of 30 minutes within an 8 hour period from first switching on. When the 30 minute or 8 hour period is exceeded the power to the Ambu® aScope™ system is switched off. When the Ambu®...
  • Page 11: Ambu® Ascope™ Monitor

    Table 4 – Functions and materials 8.2 Ambu® aScope™ Monitor The monitor displays the video image from the Ambu® aScope™. On startup, it powers the Ambu® aScope™, configures it and checks information from the Ambu® aScope™ to ensure the Ambu® aScope™ usage is acceptable.
  • Page 12 The Ambu® aScope™ Monitor can be placed on a flat surface. But to secure the Ambu® aScope™ Monitor it is recommended to use the bracket supplied. The bracket is mounted on a pole by tightening the wing nut and the Ambu® aScope™ Monitor can then be placed on the bracket. To adjust the position of the Ambu®...
  • Page 13: Connecting The System

    1. Connect the plug on the Ambu® aScope™ cable to the socket on the front of the Ambu® aScope™ Monitor. 2. Push the ON/OFF button on the Ambu® aScope™ Monitor to start up the system. After about 10 seconds the Ambu® aScope™...
  • Page 14: Connecting To An External Monitor/Video Recorder

    Figure 4 - Connecting the Ambu® aScope™ Monitor & the Ambu® aScope™ to an external monitor/video recorder 10. Clinical Application The flexible Ambu® aScope™ is designed so that it can adjust to anatomic variations. This is crucial in the management of difficult airways. It is possible to use the Ambu® aScope™ either orally or nasally.
  • Page 15: Use Of The Ambu® Ascope™ System

    Please be aware that these instructions do not explain or discuss clinical intubation procedures. They describe only the basic operation and precautions related to the operation of this Ambu® aScope™ system. Before initial use of the Ambu® aScope™ system, it is essential that the operator is familiar with the warnings, precautions, notes, indications and contrain- dications found in these user instructions.
  • Page 16: Injection And Control Of The Luer Channel

    Insertion of the Ambu® aScope™ The Ambu® aScope™ can be inserted through the mouth or nose. When the Ambu® aScope™ is inserted, slightly advance it with the distal tip in a neutral position. View the image continuously on the Ambu® aScope™ Monitor when passing the distal end of the Ambu® aScope™ from the mouth/nose to the larynx and from the larynx to the carina.
  • Page 17: Disinfection Of The Ambu® Ascope™ Monitor

    The Ambu® aScope™ Monitor is a reusable device. At the end of its product life, the Ambu® aScope™ Monitor and power supply must be disposed of in accordance with local regulations and collection schemes for disposal of electronic and electrical devices.

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