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ERT AM3 Instructions For Use Manual

Peak flow meter, option g+
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Instructions for Use
Peak Flow Meter AM3
Option G+
781195
Version 02.01
for Firmware ≥ 9.40

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Summary of Contents for ERT AM3

  • Page 1 Instructions for Use Peak Flow Meter AM3 Option G+ 781195 Version 02.01 for Firmware ≥ 9.40...

  • Page 3: Table Of Contents

    Performing Assessments and Transferring Data ........10 Lung Function Measurements with the AM3 ........14 Preparing for the Measurement ..............14 How to Perform Measurements with the AM3 ...........15 Validity of PEF Measurements ..............17 Performing Scheduled Sessions ..............17 Interrupting a Scheduled Session ...............18 Performing Unscheduled/Optional Measurements ........18...
  • Page 4 This document contains copyright information. All rights are reserved. It is not allowed to copy, duplicate or translate this manual in any other language without having the written approval of ERT before. ERT reserves the right to alter the information included in this document without notice. Names of persons men- tioned in the context of this manual are fictitious - any resemblance to living or deceased persons is purely incidental and not intended.

  • Page 5: Indications For Use

    FEV1. The AM3 is used to monitor the respiratory status of adult human beings in the areas of asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.

  • Page 6: Notes On Safety In Instructions For Use

    Notes on Safety in Instructions for Use Following the ANSI recommendations (American National Standards Institute) for safety notes, specific passages of the instruction manual are clearly marked as safety notes. Degree of Injury to Damage Use in case of: Danger Persons to Property DANGER indicates an imminently...

  • Page 7: The Peak Flow Meter Am3

    Before using the AM3 for the first time, the batteries must be charged for 30 minutes (see chapter "Power Management"). The AM3 is a medical device that combines a spirometer with a symptom diary. This device displays questions concerning asthma symptoms to be answered twice a day and measures and evaluates the Peak Flow (PEF = Peak Expiratory Flow [L/min] and/or FEV1 (FEV = Forced Expiratory Volume) as well as other expiratory parameters.
  • Page 8 The AM3 can assist in monitoring airway function on a day-to-day basis, but it is not supposed to provide an entire diagnosis of your state of health. The use of the AM3 will not replace a medical examination or other tests if you are not feeling well.

  • Page 9: Display Symbols

    Display symbols Symbol Explanation Transfer stored data manually Display signal strength and provider Settings menu Information Perform test transfer Activate/Deactivate Airplane mode Assessment Repeat measurement Optional measurement Data transfer in progress Data transfer successful Data transfer failed Memory capacity almost full (80%) Memory capacity full Battery low Version 02.01 •...

  • Page 10: General Handling

    The device is turned OFF by pressing Performing Assessments and Transferring Data The AM3 has an integrated antenna to transfer the data via SMS. As in any mobile phone, a sufficient signal strength is needed to transfer data. If the signal strength is too weak, you should search for a place with sufficient signal strength.
  • Page 11 This screen indicates that the data transfer is in progress. Please wait until the next screen appears. Afterwards, the following screens will appear implying whether the data transfer has been successful or not: By selecting on the start screen the following options will be available: Version 02.01 •...
  • Page 12 Manual data transfer: If the automatic data transfer was not possible, you can transfer the stored data manually any time by selecting The device will establish a connection and start the data transfer of stored data which has not yet been transferred. Signal and provider: You can check the signal strength and the network provider by selecting...
  • Page 13 Transmission type: By confirming the first information screen with wireless this screen will appear indicating the transmission type and SIM number. SIM no.: 0725340603 Test transfer: To test if the data transfer works correctly, a test transfer can be performed by selecting This test transfer can be performed independent of study time windows and will not contain any data.

  • Page 14: Lung Function Measurements With The Am3

    When inserting the flow sensor into the AM3, medical assistants must adhere to the general hygiene standards valid for hospitals and private practices. If the flow sensor is inserted into the AM3, the notes on cleaning as described under the chapter “Cleaning“ must be followed.

  • Page 15: How To Perform Measurements With The Am3

    How to Perform Measurements with the AM3 To perform a valid PEF measurement with the AM3, the following steps must be followed: Inhale deeply and hold your breath until you have positioned the inlet of the flow sensor into your mouth.
  • Page 16 After full exhalation, the AM should be removed from the mouth immediately. PEF Result The measured PEF is displayed on the AM3. 340 L/min The result is confirmed by pressing After the 1 measurement, you will be asked to perform the 2...

  • Page 17: Validity Of Pef Measurements

    Otherwise a message will be displayed and you will be asked to repeat the measurement. To store a result in the AM3, at least one adequate maneuver needs to be performed. If all efforts are invalid, no measurement data will be stored on the device.

  • Page 18: Interrupting A Scheduled Session

    If the AM3 is turned OFF after completing the questionnaire or between the PEF measurements, the session can be completed within the remaining time window. In this case, the AM3 has to be turned ON again and only the missing measurement may be performed - the questionnaire will not be displayed again.

  • Page 19: Power Management

    Power Management The AM3 GSM/G+ has a Li-Ion polymer battery and a power supply to charge the battery. Before using the AM3 for the first time, the battery must be charged for 30 minutes. When the battery is low (at approx. 5%), the following message will be displayed:...

  • Page 20: Memory Capacity

    Memory Capacity The following message will appear on the screen to indicate that the memory of the AM3 is almost full (80%) or completely full (no further data can be stored on the AM3). Please bring your device to each study visit to avoid reaching full memory capacity.

  • Page 21: Error Checklist

    Clean Flow Sensor according to cleaning instructions Flow Sensor is faulty Replace Flow Sensor If the proposed actions do not lead to perfect recovery of the AM3´s normal functionality, please contact your study doctor. Version 02.01 • Date 19JAN2017 Page 21/40...

  • Page 22: Cleaning

    If there are any doubts that the measurement values are correct, the rotary flow sensor has to be exchanged immediately. The sensor is intended for single patient use, only. If the AM3 is passed on to another patient, the AM surfaces will have to be cleaned and disinfected with a disinfectant.

  • Page 23: Disposal Of Sensor And Mouthpiece

    Disposal of Sensor and Mouthpiece It is absolutely vital to avoid the patient, medical assistant or sensor becoming contaminated with sputum during disassembly of the disposable sensor. Therefore, release and remove the sensor by pulling the disposable sensor downwards (see picture). Dispose of it immediately. Releaser Cleaning of Housing If the device is polluted or passed on to another patient, the AM surfaces have to...

  • Page 24: Safety Precautions Am3

    - i.e. the operator/user is not only liable for his/her modification of the medical product. ERT only guarantees for the safety, reliability and functioning of the device if: - installation, extension, modifications, and repairs are exclusively carried out by personnel authorized for these tasks by ERT.
  • Page 25 (unit). Attention: - Only the original power supply delivered with the AM3 must be used for charging the device. - Do not perform measurements if the AM3 is connected to another device.
  • Page 26 Other portable RF communication equipment (including their accessories, such as antenna cables and external antennas) should not be spaced less than 30 cm (or 12 inches) from the parts and leads of the AM3. Failure to do so may result in a reduction in the performance of the AM3.
  • Page 27 Should the measuring values of the AM3 be changed after a longer period of use, a new sensor should be used. Interfaces The AM3 must only be connected to a PC that corresponds to EN 60950 standards. If the connection cable is defective, it has to be replaced by a new one. The operator must not touch the Interfaces during measurement.
  • Page 28 (unless otherwise instructions are available). During cleaning, the AM3 must not be connected to a PC or modem. Referring to humidity and water which may get into the device, AM3 corresponds to the safety degree IP 22. This means, the device can be cleaned with a damp (in no case dripping wet) cloth which does not produce fluff.
  • Page 29 Damaged and frayed plugs, receptacles and housing or the display glass (if available) should be replaced by an authorized specialist or engineer of the ERT Customer Care. Device must not be opened. If it is opened without authorization, the guarantee entitlement expires. In case of service contact ERT.

  • Page 30: Safety Precautions For Lithium Ion Rechargeable Batteries

    - Do not come in contact with the fluid in the battery. If the fluid comes in contact with your skin, immediately rinse the affected part with water and contact a doctor! - To charge the AM3, use only the charger specified by ERT and observe the instructions in the manual! Page 30/40...

  • Page 31: Safety Precautions For Wireless Communication

    Safety and Hazards Do not operate the AM3 with wireless communication in areas where blasting is in progress, where explosive atmospheres may be present, near life support equipment, or any equipment which may be susceptible to any form of radio interference.
  • Page 32 EXPOSURE TO RF ENERGY There has been some public concern about possible health effects from using wireless communication terminals. Although research on health effects from RF energy has focused on the current RF technology for many years, scientists have begun research regarding newer radio technologies, such as 3G. After existing research had been reviewed, and after compliance to all applicable safety standards had been tested, it has been concluded that the product was fit for use.
  • Page 33 Graphical Symbols The typeplate can be Follow Instructions for Use found at the rear side of the device. Caution! General warning sign Switch the device ON and OFF Year of production Manufacturer Applied Part of Type BF Disposal in compliance with WEEE Barometric pressure limits Protection against intrusion of solid objects with a diameter ≥...
  • Page 34 Possible source of interference This device complies with Part 15 of the FCC Rules The radiation intensity of the bluetooth module is below the SAR limits which are demanded by the EC Directive 1999/519/EEC. Approval Notes: “Approved in accordance to R&TTE directive transmitter module marked by CE, manufactured by MITSUMI incorporated OEM product, and by Sierra Wireless incorporated OEM product.“...
  • Page 35 1 Watt GSM, GPRS and EDGE -1.1dBi PCS 1900 1850 to 1910 MHz 1 Watt GSM, GPRS and EDGE ERT complies with EMC guidelines according to EN60601-1-2. ERT can provide further information on EMC properties on request. Version 02.01 • Date 19JAN2017 Page 35/40...

  • Page 36: 10. Technical Data

    10. Technical Data Principle: Determination of respiratory flow and volume via exchangeable infrared rotary flow sensor. Range: Flow 0 - 840 L/min Volume 0.5 - 8 L Accuracy: Flow ± 5 % or ± 20 L/min Volume ± 3 % or ± 0.05 L Storage capacity: 1200 measurements, 400 sets of questionnaires (max.
  • Page 37 Input 100-240 Vac, 50/60 Hz, 0.3 A Output 5 V, 1.2 A Cable length 1500 mm The expected operational lifetime of the AM3 is 5 years. AM corresponds to the recommendations of ATS/ERS. Version 02.01 • Date 19JAN2017 Page 37/40...

  • Page 38: Index

    Index Off .......... 7, 10 Airplane mode ......13 Ambient Conditions ....26, 36 On ..........10 Assessment ........10 Optional Measurements ....18 Cleaning ........22 Patient Safety ....... 25 Confirmation ......... 7 PEF Measurements ....... 17 Power Management ....19 Power supply ......
  • Page 40 © 2017 eResearchTechnology GmbH or one of its affiliates. All rights reserved eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany +49 9305 720-9891 tel +49 9305 720-7891 fax...

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