Amoul i3 User Manual

Automatic external defibrillator

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User Manual
Automatic External Defibrillator
Release Version:A2.2
Revision date:2022.10.12
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Summary of Contents for Amoul i3

  • Page 1 User Manual Automatic External Defibrillator Release Version:A2.2 Revision date:2022.10.12...
  • Page 2: Table Of Contents

    1.3. Contraindication ....................1 1.4. Application ....................... 1 1.5. User qualification .....................1 2. Installation and setting ....................2 2.1. Setting i3 ......................2 2.2. CPR setting ..................... 2 3. Defibrillation ....................... 3 3.1. CPR guide ....................... 3 3.2. Preparation for rescue ..................3 3.3.
  • Page 3 7.3. Declaration on guide and manufacturer - Electromagnetic immunity .... 9 7.4. Recommended isolation distance ..............10 8. Storage and transportation ..................13...
  • Page 4: Product Information

    Product information Thanks for purchasing i3 Automatic External Defibrillator. To use the instrument correctly, please carefully read and understand the Manual before using. Keep the manual properly after reading and put it in an accessible position. Product name: Automatic External Defibrillator...
  • Page 5: Intellectual Property Right

    Intellectual Property Right © 2022 AMBULANC(SHENZHEN) TECH.CO.,LTD. All rights reserved. This product and its operating manual are the intellectual property of AMBULANC(SHENZHEN) TECH.CO.,LTD., including but not limited to patent right, trademark right and copyright. Ambulanc has the final right to interpret this manual. Ambulanc has the right to handle this manual as confidential material.
  • Page 6 Statement Ambulanc reserves the right to modify this manual without prior notice. Ambulanc reserves the right to change related technology without prior notice. Ambulanc reserves the right to alter product specification without prior notice. Ambulanc makes no warranty in any form concerning this manual, including (but not limited to) guarantee for implied marketability and adaptability for a specific purpose.
  • Page 7: Maintenance Service

    Maintenance Service Scope of Charge-Free Service: Charge-free service is provided for any equipment in the range of Ambulanc warranty terms. Scope of Paid Service: Paid service is provided for any equipment beyond the range of Ambulanc warranty terms. As well as in one of the following cases even during the warranty period: Damage caused by personal fault;...
  • Page 8 Web site: http://www.amoulmed.com E-MAIL: manager@amoulmed.com Return Return Procedure Any return as necessary shall comply with the following procedure: • Acquire right of return: Contact Ambulanc customer service, and provide the product ID labeled on external packaging of the instrument, which must be legible for return approval.
  • Page 9 Important Information After purchase of the product, the customer shall take full responsibility for maintenance and management of it. Quality assurance will not cover the following even during the warranty period: • any damage or loss resulted from improper use or misuse of the product; •...
  • Page 10: Safety Description

    11. Ambulanc will not be responsible for any damage caused by the use of this equipment after the service life of the equipment is exceeded. 12. Ambulanc will not bear the cost of transportation if the warranty request is rejected. 13.
  • Page 11 If you would like to use this device with equipment not mentioned in this manual, please consult the manufacturer. • Keep i3 away from sources of electromagnetic interference (such as motors, generators, X-ray equipment, radio transmitters, cellular mobile phones, nuclear magnetic resonance, and other equipment) as it may interfere with the signals being collected and analyzed during operation.
  • Page 12 • Do not modify this device. • Only the manufacturer AMBULANC (SHENZHEN) TECH.CO.,LTD. or its authorized professionals can perform maintenance measures such as inspection and maintenance work. Attention: • Please keep this equipment in a safe place to prevent it from falling, colliding, being subjected to strong shocks or other mechanical external forces.
  • Page 13: Accessories/Spare Parts

    Software Since a lot of quality assurance measures were taken during equipment and software development, the risk caused by software defects is negligible. Accessories/spare parts Attention: • Maintenance measures can only be taken by manufacturer (AMBULANC (SHENZHEN) TECH.CO.,LTD.) or its authorized professionals, such as inspection and overhaul.
  • Page 14: Equipment Description

    1.5. User qualification The Automatic Defibrillator i3 is intended to used by properly trained personnel in basic or advanced life support, or by personnel authorized by physicians to treat emergency defibrillation in patients with cardiac arrest.
  • Page 15: Installation And Setting

    2.2.CPR setting Tips: Under the Countdown mode, i3 provides voice prompt (1min and 30s, 1min, 40s and 20s) of rest time till the next cycle of defibrillation (start from ECG analysis). Under Countdown mode, press the flashing blue "i" within 20s after CPR start to switch...
  • Page 16: Defibrillation

    3. Defibrillation 3.1.CPR guide Tips: i3 can be used for children under 8 years old. • Please use the pediatric low-energy defibrillator electrode supplied by Ambulanc for children under 8 years old or the weight is less than 25Kg. (Please don't use the pediatric low-energy defibrillator electrode supplied by Ambulanc for adult patients.)
  • Page 17: Cpr Guide

    It will recover the ECG analysis automatically after CPR. • If it is necessary to use other defibrillators for the patient, please disconnect i3 from the patient. Before using other defibrillators, please disconnect the connection between i3 and the patient.
  • Page 18: Sanitary Treatment

    Notes: • Please don't soak the parts of i3 in the liquid. • If i3 is soaked in water, please contact with Ambulanc or its authorized representative to provide maintenance service. • Please prevent liquid from entering the equipment box.
  • Page 19: Defibrillator Electrode

    Please dispose battery according to the local laws and regulations. • Please don't put i3 battery in unsafe environment. 5.3.Defibrillator electrode Warning: • Only the electrodes supplied by the manufacturer can be used for supporting i3. Use of electrodes not specified by the manufacturer may affect the defibrillation effect.
  • Page 20: Technical Parameter

    60 minutes recording data for rescue scene (This function is optional) 7. EMC 7.1.Declaration of magnetic radiation i3 can be used for the following specific electromagnetic environment, and the user shall use the equipment in the following specified electromagnetic environment. Compliance Radiation test...
  • Page 21: Declaration Of Electromagnetic Immunity - Requirements For All Equipment Systems

    (IEC6100-3-3) 7.2.Declaration of electromagnetic immunity - Requirements for all equipment systems i3 can be used for the following specific electromagnetic environment, and the user shall use the equipment in the following specified electromagnetic environment. Electromagnetic Category of IEC 60601-1 test...
  • Page 22 <5%UT (drop: > <5%UT (drop: > outage. 95%, UT), 5s; 95%, UT), 5s; 7.3.Declaration on guide and manufacturer - Electromagnetic immunity The purchaser or user shall use i3 in the following specified electromagnetic environment: Immunity Conformance IEC 60601 test level test level...
  • Page 23 RF transmitter, consider the survey of electromagnetic place. If the field intensity of i3 is higher than the RF conformance level, observe i3 to verify whether it can work normally. If normal performance is observed, the supplementary measures may be necessary, for example, readjust the direction or position of i3.
  • Page 24 150kHz-80MH 50kHz-80MH 80MHz-800 output MHz-2.5 power (Except the (Medical W of medical engineering transmit engineering frequency frequency band) band) 0.01 0.12 0.12 0.04 0.08 0.38 0.38 0.13 0.24 1.20 0.40 0.77 3.80 1.30 2.40 12.00 12.00 4.00 7.70 Note 1: For the frequency of 80MHz and 800MHz, use the formula in higher frequency band.
  • Page 25 • Using of unapproved parts on the equipment may reduce the electromagnetic immunity of system or increase the electromagnetic emission of equipment.
  • Page 26: Storage And Transportation

    8. Storage and transportation Warning: • When the storage condition exceeds the working environment requirement and the storage state is converted into use condition, use the product after placing it in standard environment for more than 8h.

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