ERT AM3 Instructions For Use Manual

Peak flow meter, option bt+

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Instructions for use manual (40 pages)

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Instructions for Use

Peak Flow Meter AM3

Option BT+

781199

Version 01.00

for Firmware ≥ 9.40

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Summary of Contents for ERT AM3

Page 1 Instructions for Use Peak Flow Meter AM3 Option BT+ 781199 Version 01.00 for Firmware ≥ 9.40...
Page 3: Table Of Contents
Notes on Safety in Instructions for Use ..............6 Declaration of Conformity ..................6 The Peak Flow Meter AM3 ..............7 Display Symbols ...................9 Lung Function Measurements with the AM3 ........10 Preparing for the Measurement ..............10 Switching on .....................11 Measurement ....................12 Results .......................14 Data Transfer ...................15...
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 Assessment Repeat measurement Data transfer in progress Data transfer successful Data transfer failed Memory capacity almost full (80%) Memory capacity full Battery low Version 01.00 • Date 25JAN2018 Page 9/40...
Page 10: 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 11: Switching On
Your doctor or study nurse can inform you about the specific settings, for example number of measurements and any active time window. An audible reminder may be set for your AM3 to remind you to perform the measurement. Version 01.00 • Date 25JAN2018...
Page 12: Measurement
10 seconds. 2. Take the AM3 in your hand. 3. Inhale deeply and hold your breath until you have positioned the inlet of the flow sensor into your mouth. Do not breathe in through the AM3.
Page 13 4. Wait until you hear a beep. Your measured value (here PEF) is displayed. Depending on the configuration the marker will also point to the corresponding color code. After performing as many measurements as configured, the highest value measured will be displayed and automatically saved.
Page 14: Results
Results The peak flow value "PEF"** is displayed in liters per minute. If enabled, the "traffic light function" indicates the relationship between the measured value and your personal best value and possibly necessary measures. An arrow points to the respective color. Arrow points to red: Danger! Repeat the measurement and follow the instructions of your physician or case manager.
Page 15: Data Transfer
If used in combination with other devices your AM3 comes already configured for automated data transfer. Please contact your care provider for further information. If your AM3 is connected via bluetooth to a host device, data of the current measurement will be automatically transmitted immediately afterwards.
Page 16: 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 17: Display Date And Time
Display Date and Time When the AM3 is switched off, press simultaneously to enter the date and time menu. Press to exit the date/time display. Please contact your physician or case manager in case date and time need to be corrected.
Page 18 IMEI number (not available for Option BT+) Patient-ID Memory capacity for measurements Memory capacity for answers Page 18/40 Version 01.00 • Date 25JAN2018...
Page 19 Threshold green/yellow (l/min) Threshold yellow/red (l/min) Unique identifier Version (software) Daylight saving date Indication of measurement mode set for this device. PEF = Peak Expiratory Flow FEV1 = Forced Expiratory Volume after one second Version 01.00 • Date 25JAN2018 Page 19/40...
Page 20: Power Management
BT-Version BT-Address Power Management The AM3 GSM/G+/BT+ 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. Page 20/40...
Page 21 Only the original power supply delivered with the AM3 must be used for charging the device. If you switch on the AM3 while the plug-in power supply is connected, the following message will be displayed: The battery symbol indicates the state of charge.
Page 22: 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. Page 22/40 Version 01.00 • Date 25JAN2018...
Page 23: 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 24: Disposal Of Sensor And Mouthpiece
10.3 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 10.4 Cleaning of Housing If the device is polluted or passed on to another patient, the AM surfaces have to...
Page 25: 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 26 (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 27 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 28 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 29 (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.
Page 30: Safety Precautions For Lithium Ion Rechargeable Batteries
Improper disposal of the device and/or its accessories can result in serious environmental hazard. 11.1 Safety Precautions for Lithium Ion Rechargeable Batteries The AM3 is powered from an internal Lithium-Ion Polymer battery. The following safety precautions are valid for Lithium-Ion batteries: - Do not waste the battery.
Page 31: Safety Precautions For Wireless Communication
- 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! 11.2 Safety Precautions for Wireless Communication For the efficient and safe operation of your AM3, please read the following information carefully.
Page 32 EFFICIENT TERMINAL OPERATION For your wireless communication terminal to operate at the lowest power level, consistent with satisfactory transfer quality: Do not hold the device when the transfer is in progress. Holding the antenna affects transfer quality and may cause the wireless communication module to operate at a higher power level than needed.
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 IP 22...
Page 34 CAUTION: FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE only ORDER OF A PHYSICIAN. 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.
Page 35 - Reorient or relocate the receiving antenna. - Increase the separation between the equipment and receiver. - Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. - Consult the dealer or an experienced radio/TV technician for help. This device complies with Industry Canada licence-exempt RSS standard(s).
Page 36: Notes On Emc According To En60601-1-2
Guidance and Manufacturer‘s Declaration – Electromagnetic Emissions and Immunity The AM3 uses RF energy for internal function. Therefore, its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment. The AM3 is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Page 37: Technical Data
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 01.00 • Date 25JAN2018 Page 37/40...
Page 38: Index
Off ..........7 Ambient Conditions ....27, 37 Cleaning ........23 Patient Safety ....... 26 Confirmation ......... 7 Peak Flow Meter AM3 ....7 Power Management ....20 Power supply ......21, 37 Declaration of Conformity ....6 Display ........... 7 Display Symbols ......

ERT AM3 Instructions For Use Manual

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