ERT AM3 Instructions For Use Manual Download Page 40

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eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
+49 9305 720-9891 tel
+49 9305 720-7891 fax

Summary of Contents for AM3

Page 1: ...Instructions for Use Peak Flow Meter AM3 Option G 781195 Version 02 01 for Firmware 9 40 ...

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Page 3: ...asurement 14 4 2 How to Perform Measurements with the AM3 15 4 3 Validity of PEF Measurements 17 4 4 Performing Scheduled Sessions 17 4 5 Interrupting a Scheduled Session 18 4 6 Performing Unscheduled Optional Measurements 18 5 Power Management 19 6 Memory Capacity 20 7 Error Checklist 21 8 Cleaning 22 8 1 Cleaning of Sensor 22 8 2 Checking the Sensor 22 8 3 Disposal of Sensor and Mouthpiece 23 8 ...

Page 4: ...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 Subject to technical modifications This Instructions for Use is for the patient only For all medical personal please use the more detailed MasterScope IFU article no 782126 If you have any q...

Page 5: ...nt s physician The device saves the results of a measurement always with date and time automati cally in an internal database In addition questionnaire functionality can be called up by the use of a software package AMOS to record e g the Quality of Life status When enabled the AM3 can be programmed with a couple of questions where the patient can then select from a couple of different answers Thi...

Page 6: ...e most extreme situations X WARNING indicates a potentially hazardous situation which if not avoided could result in death or serious injury X X CAUTION 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 Notes on Safety in Instructions for Use Declaration of Conformity Additional icons shown ...

Page 7: ... and or FEV1 FEV Forced Expiratory Volume as well as other expiratory parameters The device keeps a diary of measurements by automatically recording in its memory all answers and measurements with date and time The AM3 Equipment comprises of AM3 Power supply Bag Before using the AM3 for the first time the batteries must be charged for 30 minutes see chapter Power Management Confirmation Scroll up ...

Page 8: ...re trouble breathing severe cough that will not stop trouble talking or walking severe chest tightness or wheezing over inflated chest or ribs lips or fingernails which are bluish rather than pink or if you require treatment with oral or parenteral glucocorticosteroids have been admitted to hospital including emergency room treatment are concerned about your condition during the study Trouble free...

Page 9: ...ata manually Display signal strength and provider Information Perform test transfer Activate Deactivate Airplane mode Assessment XX Repeat measurement 1 2 Optional measurement Data transfer in progress Data transfer successful Data transfer failed Memory capacity almost full 80 Memory capacity full Battery low ...

Page 10: ... two selectable options 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 It is important that the device is not shielded by any objects particularly metal or thick walls e g cellar OK ESC Study ID Press arrow k...

Page 11: ...ill appear implying whether the data transfer has been successful or not This screen indicates that the data transfer is in progress Please wait until the next screen appears By selecting on the start screen the following options will be available OK ESC OK ESC OK ESC OK ESC ...

Page 12: ...f stored data which has not yet been transferred Signal and provider You can check the signal strength and the network provider by selecting The more black bars are visible the better the signal strength At least one bar is necessary to successfully transfer data Info Select to indicate the number of data sets which have been stored acknowledged sent and failed OK ESC Telekom de OK ESC Data sets 0...

Page 13: ...transfer can be performed independent of study time windows and will not contain any data Airplane mode When travelling by airplane turn Off mobile communication airplane mode active to prevent possible interference with aircraft systems by selecting During activated Airplane mode the Bluetooth and the mobile communication function are disabled As long as the airplane mode is active a small airpla...

Page 14: ...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 4 Lung Function Measurements with the AM3 4 1 Preparing for the Measurement Sealing cap Flow sensor AM3 Flow sensor The flow sensor can be used multiple times but should only be used by the ...

Page 15: ...sitioned the inlet of the flow sensor into your mouth You should pause for about a second and then blow out hard and fast as you can not cough not block the inlet of the flow sensor with your tongue not block the outlet of the flow sensor with your hand If you do not follow these instructions the correctness of the measure ment values cannot be guaranteed 2 Now you must exhale as hard as possible ...

Page 16: ...mmediately 4 The measured PEF is displayed on the AM3 OK ESC OK ESC 5 The result is confirmed by pressing OK After the 1st measurement you will be asked to perform the 2nd and the 3rd PEFs repeat steps 1 5 PEFResult 340L min 6 At the end of the session the highest PEF will be displayed HighestPEF 350L min ...

Page 17: ...ll be displayed and you will be asked to repeat the measurement 4 4 Performing Scheduled Sessions Scheduled sessions including questionnaire and PEF measurements can only be performed and stored using programmed devices For completing your questionnaire you can scroll through and select the appropriate answer by using and buttons and pressing OK At the end of the questionnaire you will be asked if...

Page 18: ...screen on the left will be displayed after turning the device ON The data from unscheduled optional measurements is for information only and will NOT be stored OK ESC 1 2 4 5 Interrupting a Scheduled Session If the AM3 is turned OFF before finishing a questionnaire all questions previously answered will not be saved If the AM3 is turned OFF after completing the questionnaire or between the PEF mea...

Page 19: ...s when the internal battery is fully discharged When the battery is low at approx 5 the following message will be displayed At this point of discharge you have 24 hours to connect the AM3 to the power supply before the battery is fully discharged How to charge the battery Plug one end of the wall adapter into the USB interface of the AM3 and the other end into a wall socket Only the original power...

Page 20: ...played The battery symbol indicates the state of charge Please bring your device to each study visit to avoid reaching full memory capacity 6 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 OK ESC OK ESC OK ESC ...

Page 21: ...ing the OK button press and hold the ESC button Hold both buttons for approximately 2 seconds Result of measurements is questionable A Flow Sensor is not inserted correctly Insert Flow Sensor correctly B Flow Sensor is dirty Clean Flow Sensor according to cleaning instructions C Flow Sensor is faulty Replace Flow Sensor If the proposed actions do not lead to perfect recovery of the AM3 s normal fu...

Page 22: ...on the sensor Air dry and reinsert the sensor Any minor discoloration in the sensor does not affect the performance of the AM3 The Cleaning of the sensor should be performed every week or more frequently if often heavily polluted Furthermore it is recommended to exchange the rotary flow sensory with a new one after one year of use or 2000 measurements If the sensor is heavily polluted frequently t...

Page 23: ...ry ammonium compound for example Cleanisept Wipes by Dr Schumacher GmbH The method of application provided by the disinfectant manufacturer have to be considered 8 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...

Page 24: ...erforming a corresponding conformity assessment procedure within in house manufacture see 12 paragraph 1 last sentence of MPG Medizinproduktegesetz Medical Products Act The operator user is however not only responsible for performing the conformity assessment correctly but is also completely liable for defective products i e the operator user is not only liable for his her modification of the medi...

Page 25: ...comply with the respective EN or ISO standards e g EN 60950 for data processing equipment Furthermore all configurations shall comply with the requirements for medical electrical systems Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems Attent...

Page 26: ...ved equipment can result in increased electromagnetic interference or reduced electromagnetic immunity of the medical device and can lead to faulty operation 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 reductio...

Page 27: ...y of subjects It is recommended that subjects should not be tested within 1 month of a myocardial infarction In rare cases spirometry testing can lead to syncope due to extensive exhalation Furthermore the following conditions probably lead to suboptimal lung function results Chest or abdominal pain of any causes Oral or facial pain exacerbated by a mouthpiece Stress incontinence Dementia or disor...

Page 28: ...mation can be found under Cleaning Chemicals required for operation or care of the unit have to be used in accordance with instructions of the manufacturer and must always be stored prepared and made available in specially marked vessels to prevent any mistakes massive pneumothorax within the first weeks abdominal or thoracic surgery depending on the findings 1 to 4 weeks postoperatively surgery o...

Page 29: ...e fallen off Children should neither get in contact with disposables accessories and packing material nor with cleaning and disinfection substances Recycling Adhere to the national law in your country when disposing the medical device and its accessories Improper disposal of the device and or its accessories can result in serious environmental hazard Damaged and frayed plugs receptacles and housin...

Page 30: ...heat Protect the battery against direct sun light Protect the battery against fire Do not dismantle or manipulate the battery Do not replace the battery The fluid of the battery is toxic and flammable leaky batteries or batteries with dents must not be used any longer Do not come in contact with the fluid in the battery If the fluid comes in contact with your skin immediately rinse the affected pa...

Page 31: ...communication module MUST BE SWITCHED OFF When operating the wireless communication module can transmit signals that could interfere with various onboard systems Note Some airlines may permit the use of cellular phones while the aircraft is on the ground and the door is open The wireless communication module may be used at this time RF Safety GENERAL The AM3 uses a wireless communication module ba...

Page 32: ...In addition you can reduce RF exposure by operating your cellular terminal efficiently by following the guidelines below 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 wireles...

Page 33: ...ction against intrusion of solid objects with a diameter 12 5mm dripping water when tilted up to 15 Serial Number CE sign with code number of the Notified Body The certified quality management system of eResearchTechnology GmbH corresponds to the international standard of ISO 13485 Rx only CAUTION FEDERAL U S LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Graphical Symbols The...

Page 34: ...rmined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures 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 techn...

Page 35: ...i même si le brouillage est susceptible d en compromettre le fonctionnement IC 5123A BGTBT121 IC 11335A AM3G02 Frequency Band Transmission Frequency Range Maximum Output Power Gain UMTS B1 1922 to 1978 MHz 23 dBm 2dBm Class 3bis 1 74 dBi UMTS B2 1852 to 1908 MHz 23 dBm 2dBm Class 3bis 1 1 dBi UMTS B5 826 to 847 MHz 23 dBm 2 dBm Class 3bis 3 31 dBi UMTS B6 832 to 838 MHz 23 dBm 2 dBm Class 3bis UMT...

Page 36: ... Battery will last under standard operating conditions for about 40 days Full charging 2 h Cycle life 80 of rated capacity after 300 cycles 60 of rated capacity after 500 cycles Dimensions Length x width x height Weight 112 x 82 x 37 mm 150 g battery included Ambient conditions Temperature Relative humidity Barometric pressure 10 C to 40 C 15 to 95 not condensing 700 to 1060 hPa Transport and stor...

Page 37: ... Applied part Type BF whole device Protection class Battery Device Mode of operation Continuous operation Max resistance 0 002 kPa L min at 720 L min Interface USB 2 0 Bluetooth 4 2 Smart Ready 3G Medical Power supply battery charging WR9QA1200MUNMRVG2773 Model GTM41134 0605 Input 100 240 Vac 50 60 Hz 0 3 A Output 5 V 1 2 A Cable length 1500 mm ...

Page 38: ... FEV1 17 Flow sensor 14 FVC 17 H Hazards 31 L Lithium Ion battery 30 M Manual transfer 12 O Off 7 10 On 10 Optional Measurements 18 P Patient Safety 25 PEF Measurements 17 Power Management 19 Power supply 19 36 S Safety Precautions 24 30 31 Scheduled Session 18 Scroll down 7 Scroll up 7 Sealing cap 14 Symbols 9 T Transfer Menu 10 U Unscheduled Measurements 18 V Validity 17 W Wireless Communication...

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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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