eResearchTechnology AM3G01 The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. User Manual UserMan

eResearchTechnology GmbH The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. UserMan

UserMan

782042-xxxxxxUSENVersion 00.03Instructions for UsePeak Flow Meter AM3 for Trial xxxxxxLogo· Option AM3 GSM
Page 2/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Product names or services are trademarks of their respective companies.All rights, including those of translations, are reserved. Written permission of eResearchTechnology (ERT) shall be obtained for the reproduction of this manual or any excerpt thereof by any means, including printing, photo static duplication, microfilms, or any other processes.eResearchTechnology GmbHSieboldstrasse 397230 Estenfeld, GermanyTel: +49 9305 720-9891Fax: +49 9305 720-7891www.ert.com© 2013 eResearchTechnology GmbH. All rights reserved.782042_TPL_AM3_IFU_FDA_2013-11-04
Page 3/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Table of ContentsIndications for Use ................................................................................................ 4ERT Customer Care Contacts ................................................................................ 5ERT Toll-Free Hotline ............................................................................................. 6Notes on Safety in Instructions for Use .................................................................. 7Declaration of Conformity ..................................................................................... 71. The Ambulatory Monitoring Equipment ............................................. 82. The Peak Flow Meter AM3 .................................................................... 82.1 Handling.................................................................................................102.1.1 Turning the Device ON in Subject Mode .................................................. 102.1.2 Turning the Device ON in Investigator Mode ........................................... 102.1.3 Turning the Device OFF ........................................................................... 102.1.4 TUTORIAL Devices ................................................................................... 102.1.5 New Subject Devices ............................................................................... 112.1.6 Assigned Subject Devices ........................................................................ 112.2 PEF Measurements with the AM ............................................................. 112.2.1 Preparing for the Measurement .............................................................. 112.2.2 Performing Scheduled Sessions ............................................................... 122.2.3 How to Perform PEF Measurements with the AM .................................... 122.2.4 Validity of PEF Measurements ................................................................. 132.2.5 Interrupting a Scheduled Session ............................................................ 142.3 Performing Unscheduled/Optional PEF Measurements ............................. 142.4 Device Settings (Service Mode) ................................................................ 152.5 Power Management ............................................................................... 172.6 Memory Capacity ................................................................................... 183. Cleaning................................................................................................ 193.1 Disposal of Sensor ................................................................................. 193.1.1 Cleaning the Disposable Mouthpiece/Rotary Flow Sensor ........................ 203.1.2 Cleaning the Case .................................................................................. 203.1.3 Checking the Sensor ............................................................................... 204. Error Checklist ...................................................................................... 215. General Safety Precautions .................................................................225.1 Safety Precautions for Lithium Ion Rechargeable Batteries ...................... 255.2 Safety Precautions for GSM Option ......................................................... 26Literature ............................................................................................................ 30Notes on EMC according to EN60601-1-2 ........................................................... 31Return of Goods in Medical Institutions ............................................................... 35Technical Data .................................................................................................... 39Index .............................................................................................................. 41This 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 mentioned 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.
Page 4/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Indications for UseThe Asthma Monitor AM3/AM3 BT/AM3 GSM is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM3 measures the flow during expiration serving far the calculation of further parameters as FEV1.The AM3 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient’s physician.The device saves the results of a measurement (always with date and time) automatically in an internal database. In addition, a 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 select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.The AM3 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. (Rx only)The AM can be utilized for subjects from 4 years on and older as long as they can cooperate in the performance. The application of this system is restricted to trained subjects who can guarantee for the correct usage of the device.The AM is powered with a Lithium-ion battery. No energy is transferred to the subject.
Page 5/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013ERT Customer Care ContactsInternational SupportInternational telephone technical support is available to all CRAs and Investigators in English; Monday through Sunday, 24 hours a day (see next page for contact details).International Support is responsible for all hardware and software issues and should be contacted as soon as a problem occurs at a site.Please have the following information available when you call:• Studyname• Sitenumber• Subject/CRFNumberorSysNumber• Whetherthisissuehasbeenreportedbytherespectivesitetothe hotline before The Technical Hotline Operator will ask you for this information in order to provide the most efficient service.International GermanyeResearchTechnology GmbH Sieboldstrasse 397230 Estenfeld, GermanyCustomerCare@ert.comInternational USeResearchTechnology 1818 Market Street, Suite 1000Philadelphia, PA 19103-3638CustomerCare@ert.com
Page 6/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013ERT Toll-Free HotlineIftheabovenumbersarenotavailableoractive,pleasedial+4993057209891.Youwillbecalledbackassoonaspossibleifthesupportlineisbusyandyouleaveamessage.*Before dialing 888 ... please wait until you are prompted by the operator.Country Toll-FreeNumberArgentina 0800 6660824Australia 1800 008184Austria 0800 293169Belarus 8820 04910016Belgium 0800 79185Brazil 0800 8911518Bulgaria 00800 1104905Canada 1866 8415042Chile 1230 0202398China (North) 10800 7490031China (South) 10800 4900031Colombia 01800 9155750Costa Rica 0800 0440047Croatia 0800 222992Cyprus 800 93295Czech Republic 800 142391Denmark 8088 2178Dom. Rep. 1800 3711741Ecuador 1800 225 528,,,(3sec)888 680 1981Egypt 0800 0000366Estonia 800 0049006Finland 0800 116605France 0800 900585Germany 0800 1015390Greece 00800 49129105Guatemala 138126,,,(3sec)888 680 1981Honduras 800 0123,,,(3sec)888 680 1981Hong Kong 800 964138Hungary 0680 015946Iceland 800 8226India 000800 4401432Indonesia 0018 038529591Ireland 1800 554931Israel 180 9455201Italy 800 786498Japan 00531 121370Korea 0079814 8006214Country Toll-FreeNumberLatvia 8000 0266Lithuania 8800 30046Luxembourg 800 26390Macedonia 0800 98152Malaysia 1800 808847Malta 800 62476Mexico 001866 8415042Monaco 800 93366Netherlands 0800 0235262New Zealand 0800 443629Norway 800 11592Panama 001800 5071923Peru 0800 52161Philippines 1800 14910008Poland 00800 1211385Portugal 800 812743Puerto Rico 1 888 680 1981Romania 0800 896647Russia 8108002 4883011Serbia 0800 190144Singapore 800 1204116Slovakia 0800 004982Slovenia 0800 80885South Africa 0800 995609Spain 900 994964Sweden 02079 8198Switzerland 0800 562403Taiwan 00801 137512Thailand 001800 120664985Turkey 0811 2880001,,,(3 sec)888 7922117Ukraine 0800 503275United Kingdom 0800 7314027United States 1800 7049698Uruguay 000413 5983021Uzbekistan 8,6417440010,,,(3 sec)888 680 1980Venezuela 800 1006321List needs to be updated if Bosnia or Tunesia are included in the study!!!!!
Page 7/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Declaration of ConformityThe original document of the Declaration of Conformity can be found in the Accompanying Documents.Following the ANSIrecommendations (American National Standards Institute) for safety notes, specific passages of the instruction manual are clearly marked as safety notes.Additional icons shown in the instruction manual:Degree of Danger Injury to PersonsDamage to Property Use in case of: XDANGERindicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. This signal word is to be limited to the most extreme situations. XWARNING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 Important and useful information. Information does not warn of dangerous or harmful situations. Hints for use.
Page 8/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20131. The Ambulatory Monitoring EquipmentThe Ambulatory Monitoring Equipment comprises of:· Tutorial Peak Flow Meter AM· Subject Peak Flow Meter AM· Power supply· Mouthpiece· BagWith the help of the Peak Flow Meter, the subject records his/her symptoms and performs peak flow measurements. Study specicDisplayReleaserFlow SensorConrmationScroll upScroll downOffMouthpieceFront view:2. The Peak Flow Meter AM3The AM is an instrument that combines a peak flow meter 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]). The device keeps a diary of subject measurements by automatically recording in its memory all answers and PEF measurements with the date and time. Every time the subject visits the center, the data will be downloaded by using the analogue modem.
Page 9/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013WarningThe AM can assist in monitoring airway function on a day-to-day basis, but it CANNOTprovide an entire diagnosis of the subject’s state of health. The use of the AM will not replace a medical examination or other tests if the subject is not feeling well.The subject should be instructed to call the study doctor immediately if he/she shows any symptoms of:• Severe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• Thesubjecthasrequiredtreatmentwithoralorparenteral   glucocorticosteroids.• Thesubjecthasbeenadmittedtohospital(includingemergencyroom treatment).• Thesubjectisconcernedabouthis/herconditionduringthestudy.Trouble-free operation of the AM is guaranteed for temperatures from +10° to +40°C (50° to +104°F).It is recommended NOT to perform measurements in direct sunlight, as the sensor could be damaged.RS232 interfaceUSB interface (used for charging)Bottom view:
Page 10/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20132.1 Handling2.1.1 Turning the Device ON in Subject ModePress and hold the button. While holding the button, press and hold the button. Hold both buttons for approximately 2 seconds.2.1.2 Turning the Device ON in Investigator ModeTo turn ON the device, press and hold the button. While holding the button, press and hold the button. Hold both buttons for approximately 2 seconds. After releasing the buttons the investigator password is requested. The investigator password is distributed during the study training or is available from the ERT Hotline.The Investigator Mode needs to be turned ON, whenever there is a need to enter or change settings on the Peak Flow Meter or the modem.2.1.3 Turning the Device OFFThe device is turned OFF by pressing .TUTORIAL devices DO NOT STORE any data. That is why it is not possible to use them as subject devices.TUTORIAL devices CANNOTbe changed into subject devices.2.1.4 TUTORIAL DevicesEach site receives a “TUTORIAL DEVICE“ to train site staff and subjects on how to operate the device correctly.In Tutorial Mode, it is possible to have the subject simulate morning and/or evening sessions. The site staff can also simulate administrative functions such as dispensing the AM or closing the AM.Tutorial Device - Tutorial SessionMorningPress arrow keys to select your choiceEvening
Page 11/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Study specic2.2 PEF Measurements with the AM2.2.1 Preparing for the MeasurementPrior to starting the measurement, place the flow sensor into the AM as shown below. Remove the sealing cap from the flow sensor and put on the mouthpiece.When inserting the flow sensor into the AM, medical assistants must adhere to the general hygiene standards valid for hospitals and private practices. If the flow sensor is inserted into the AM by the subject, the notes on cleaning as described under the chapter “Cleaning“ must be followed.The flow sensor and the mouthpiece are intended for single subject use only.2.1.5 New Subject DevicesNew subject devices are locked, and cannot be used until they are programmed with a subject number.2.1.6 Assigned Subject DevicesAfter programming the AM with the subject’s unique number, the device is ready to be used by the subject. Protocol 000.000NEW DEVICESealing capFlow sensorMouthpieceAM3Flow sensor
Page 12/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20132.2.2 Performing Scheduled SessionsScheduled sessions, including questionnaire and PEF measurements, can only be performed and stored using programmed subject devices. Following the study protocol, the subject has to carry out two scheduled sessions per day. The subject can scroll through and select the appropriate answer by using and buttons and pressing .At the end of the questionnaire the subject is asked, if he/she wants to change an answer; if the subject selects “Yes“, the questionnaire will be displayed again.The answers previously entered will appear as default, and can be modified as described above. After answering the last question, the subject should complete the three PEF measurements. Study specic2.2.3 How to Perform PEF Measurements with the AMTo perform a valid PEF measurement with the AM, the following steps must be followed:1. The subject inhales deeply and holds the breath until he/she has positioned the mouthpiece of the AM into his/her mouth.3. After full exhalation, the AM should be removed from the mouth immediately. The subject should not breathe in through the mouthpiece.2. Now the subject must exhale as hard as possible for at least 2 seconds to obtain a satisfactory measurement.The subject should:• notcough.• notblockthemouthpiecewithhis/hertongue.• notblocktheoutletoftheflowsensorwithhis/herhand.• beinstructedtopauseforaboutasecondandthenblowouthardandfast as he/she can.
Page 13/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20132.2.4 Validity of PEF MeasurementsA PEF measurement performed with the AM is valid, if:• Breathingvolume>0.47Lor<10L• Breathingflow>50L/min• FVC>FEV1If a PEF measurement is invalid, a message will be displayed and the subject will be asked to repeat the measurement.To store a result in the AM, at least one adequate PEF needs to be performed.If all efforts are invalid, no PEF data will be stored on the device.4. The measured PEF is displayed on the AM.5. The result is confirmed by pressing .After the 1st measurement, the subject will be asked to perform the 2nd and the 3rd PEFs (repeat steps 1- 5).At the end of the session, the highest PEF will be displayed. Result PEF220 L/minHighest PEF250 L/minInadequate effort!Please try again!
Page 14/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20132.2.5 Interrupting a Scheduled SessionIf the device is turned OFF before finishing a questionnaire, all questions previously answered will not be saved. If the device 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 device has to be turned ON again and only the missing PEF measurements may be performed - the questionnaire will not be displayed again.2.3 Performing Unscheduled/Optional PEF MeasurementsIn addition to scheduled PEF measurements, the subject is able to perform unscheduled/optional PEF measurements. These are measurements that are: • performedafterhavingfinishedthescheduledmeasurementswithinatime window • performedoutsideofthestudyspecifictimewindowsWhen performing an unscheduled/optional measurement, the screen on the left will be displayed after turning the device ON.Study specicThe data from unscheduled/optional measurements will NOT be stored.Take a very deep breath and measure your PEF!optional
Page 15/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20132.4 Device Settings (Service Mode)The Service Mode must be activated to view the following AM settings: Study ID, date and time, serial number of the AM, ERT Study ID, Site and Subject number, battery status, the percentage of stored measurements and answers, the date of last data transfer and some technical settings.To turn the AM ON in Service Mode, press and hold the button. While holding the button, press and hold the button. Hold both buttons for approximately 2 seconds. The following screen will appear:After pressing the following screen is displayed:After pressing the following screen is displayed:Study IDDate and timeXXXXXXXXXXXDate/Time25.08.09 13.05Battery status (FULL, OK, or NOK)System-generated numberSerial number of AMSerialno.: E001569XXXXXX-XXXXXX-145123Battery: OKMEMORY STATUSMeasurements: 0%Answers: 0%AM storage capacityERT Study ID
Page 16/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013After pressing again, further technical AM settings are displayed.RV1:— RV2:—-RV3:— RV4:—-RV5:— RV6:—-RV7:— RV8:—-Reference valuesSoftware congurationMajor software versionAM3 Conguration:XXXXXX-001-GBEN-GVers.:9.21..01.00DLT: 10.07.09Date of last data transferSettings can only be checked, NOT changed.Contact your CRA or the ERT Hoteline if you have any concerns regarding the displayed settings. Pressing will turn the device OFF.
Page 17/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20132.5 Power ManagementBefore using the AM for the first time, the batteries must be charged for 30 minutes. When the batteries are low, the following message will be displayed:Battery low!Please connect AM3 to charger.How to charge the batteries:Plug one end of the wall adapter into the USB interface of the AM3 with GSM option and the other end into a wall socket.Only the original power supply delivered with the AM must be used for charging the device.The internal clock will stop after about 5 days when the internal battery is discharged.
Page 18/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013If you switch on the AM3 while the plug-in power supply is connected, the following message will be displayed:Please disconnect from charger or PC to perform your session.The battery symbol indicates the state of charge.As soon as the memory is full, no further data can be stored on the AM.Please advise subjects to bring their devices to each study visit to avoid reaching full memory capacity.2.6 Memory CapacityThe following message will appear on the screen to alert the subject that the memory of the AM is almost full (80%).Memory almost full!Please contact your doctor!Memory full!Please contact your doctor!
Page 19/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013The sensor is intended for single-patient use, only. Dispose of used sensors if the AM is passed on to another patient. The mouthpiece is intended for single-patient use, only. Dispose of used mouthpieces if the AM is passed on to another patient. Sensor Cleaning:Release and remove sensor, rinse it with distilled water in which a mild cleansing agent is soluted.Shake off any remaining water on the sensor. Air-dry and reinsert the sensor.The sensor is intended for single patient use, only. If the AM is passed on to another patient, the AM surfaces will have to be cleaned. See next page for informa tion on disposal of a used sensor.3.1 Disposal of Sensor MouthpieceReleaserFlow sensor3. Cleaning
Page 20/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Disposal: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 down-wards (see picture). Dispose of it immediately.Releaser3.1.1 Cleaning the Disposable Mouthpiece/Rotary Flow SensorTo clean the rotary sensor of the AM3, release the sensor by moving the releaser sidewards. It is recommended to clean the outer parts of the sensor every 4 weeks with a damp (not wet) cloth or tissue and letting the sensor air-dry at room temperature. Place the sensor back in the AM. The disposable mouthpiece can be cleaned under running water.Any minor discoloration in the sensor does not affect the performance of the AM.DONOTuse alcohol or any type of household cleaner!3.1.2 Cleaning the CaseWipe off the case with a moist cloth. Then dry the case with a cotton towel.3.1.3 Checking the SensorIf the patient’s AM does not measure accurately, clean the sensor as described above. If there are still doubts that the device is not working correctly, exchange the sensor or contact the responsible Monitor or ERT Customer Care Helpdesk.
Page 21/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20134. Error ChecklistIf the proposed actions do not lead to perfect recovery of the AM´s normal functionality, please contact the ERT Hotline.Error Description Reason ActionNoresponseduringpowerONA. AM battery is empty Charge the AM3B. Buttons and are not pressed correctly•Pressandholdthe button.•Whileholdingthe button, press and hold the button.•Holdbothbuttonsforapproximately 2 seconds.Clock is not working correctlyReprogram AM by connecting it to the modem. If problem occurs again replace AM.ResultofmeasurementsisquestionableA. Flow Sensor is not inserted correctlyInsert Flow Sensor correctlyB. Flow Sensor is dirty Clean Flow Sensor according to cleaning instructionsC. Flow Sensor is faulty Replace Flow Sensor
Page 22/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20135. General Safety PrecautionsTheInstructionsforUseisregardedtobeapartoftheinstrument,andshould always be kept on hand.The instruction manual describes the present state of the device/system including software and accessories with regard to the fundamental requirements of the MDD 93/42/EEC. Exact adherence to the instructions issued is a prerequisite for perfect and intended functioning of ERTinstruments.DeviationfromIntendedUseAny non-observance of the procedures (such as preparing for the measurement and methods, disinfecting procedures, use of accessories and replacement parts etc.) described in the Instructions for Use results in a deviation from intended use.In case of a deviation from intended use the operator/user has to supply proof of meeting all corresponding fundamental requirements. This is possible by performing a corresponding conformity assessment procedure within in-house manufacture (see § 12, paragraph 1 last sentence of MPG (= Medizinprodukte-gesetz/ 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 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.- the ambient conditions at the place of installation are suitable for the device.- the device is used according to the training manual and instructions for use.- Unpack your medical device. Please check if the unit is damaged. If so, do not use it and return it for a replacement. The user has to follow the instructions. If the user doesn’t obey the safety precautions this can lead to hazardous situations which can lead toinjuryordeathofthepatientand/ordestructionofthedevice.Electrical SafetyThe AM is powered from an internal lithium Ion rechargable battery, the battery can be charged over a direct plug-in power supply (unit).Attention:- Only the original power supply delievered with the AM must be used for charging the device.- Do not perform measurements if PC is connected.- Data transfer is not permitted during measurement.General Safety Precautions
Page 23/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013General Safety Precautions ValidforallERTDevicesAdditional equipment connected to medical electrical equipment must 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. Atten-tion is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the ERT Customer Care.RadiatedInterferenceThe ERT device meets the regulations according to EN 60601-1-2 regarding interference radiated and received. The device should not be installed in the vicinity of high-frequency devices, X-ray equipment, motors or transformers with high installed power rating, since electric or magnetic interference fields may falsify the results of measurements or make taking measurements impossible. Due to this, the vicinity of power lines is to be avoided as well. Existing environmental interferences may cause deviations of the measuring values without impairing the device’s function.Therefore, it is recommended to keep a distance of about 2 meters from possible error sources when using the device. If available: More detailed information can be found in the EMC tables of the Instructions for Use of your device. Ambient ConditionsAM3 must not be operated in rooms or in the presence of flammable anaesthetic mixture with air or flammable anaesthetic mixture with oxygen or nitrous oxide.AM3 has to be effectively protected against moisture. Therefore, it is required that the AM3 is always stored in the black bag. The device corresponds to IP 22 degree of protection. Measurements in the rain or in the shower are not allowed.Measuring ModeAs the combination with an IEC 60950-1 proofed PC or modem can lead to a summation of the leakage current, the AM3 must not be connected to a PC or modem during the measurement.Should the measuring values of the AM3 be changed after a longer period of use, a new sensor should be used. InterfacesThe 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 physician must not touch the patient and live parts at the same time. The operator must not touch the Interfaces during measurement.PatientSafetyaccordingtoEN60601-1The subject has to keep a distance of at least 1,5 m from a connected modem or notebook to avoid any contact with electrical voltage. The physician/operator must not touch any voltage-carrying parts and the subject at the same time.
Page 24/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Contraindicationsandpossibleadverseeffects:According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically demanding for a minority of patients. It is recommended that patients should not be tested within 1 month of a myocardial infarction. In rare cases spirometry testing can lead to syncope due to extensive exhalation.PuttingtheDeviceintoOperationTemperature changes may give rise to condensation in the device. Consequently, the device has to adapt to the ambient temperature before putting it into operation. Cleaning and HygienePrior to every application, all parts which come in contact with the patient and which are intended for reuse must be cleaned or disinfected (unless otherwise instructions are available).Prior to measuring a subject, his/her anamnesis is to be checked in order to avoid a contamination of the device and a resulting cross contamination of the next subject.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. More detailed information can be found under “Cleaning”. Chemicals required for operation or care of the unit must always be stored, prepared, and made available in specially marked vessels to prevent any mistakes.MaintenanceThe device doesn’t require to perform preventive inspection, maintenance and calibration. No part of the AM3 should be replaced by the subject/doctor. Use ERT approved accessories and spare parts for this medical device, only.If the device/applied part has been exposed to extreme mechanical stress, a function test has to be performed. If function is lost, the defective part is to be replaced.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.General Safety Precautions MedicalSupervisionA qualified physician has to reassess all AM3 measurements. An interpretation by the AM3 is only important if it is considered in connection with other clinical findings.
Page 25/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013General Safety Precautions RecyclingAdhere 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.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.- Do not shortcut the battery.- Protect the battery against excessive 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 con-tact with your skin, immediately rinse the affected part with water and contact a doctor!- Keep the batteries away from children.- To charge the AM3, use only the charger specified by the manufacturer and observes the instructions in the manual!5.1 Safety Precautions for Lithium Ion Rechargeable Batteries Children should not get in contact with disposables, accessories and packing material and cleaning and disinfection substances.Before turning on the device, you should always check whether the device is free from defects. Immediate maintenance is necessary, if:- the display glass bursts or breaks: Caution:riskofinjury- the device has been mechanically stressed in the extreme (e.g. impact, damage to the housing)- liquid got into the device- the connection cable is defective. The connection cable has to be replaced by a new one.- coverings have fallen off.
Page 26/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20135.2 Safety Precautions for GSM OptionFor the efficient and safe operation of your AM3 with GSM option, please read the following information carefully.Safety and HazardsDo not operate the AM3 with enabled GSM option 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. In such areas, the GSM modem MUST BE POWERED OFF. The AM3 with enabled GSM option can transmit signals that could interfere with this equipment. Do not operate the GSM any aircraft, whether the aircraft is on the ground or in flight. In aircraft, the GSM option MUST BE SWITCHED OFF. When operating, the GSM modem 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 GSM option may be used at this time.RFSafetyGENERALThe AM3 uses a GSM module based on the GSM standard for cellular technology. The GSM standard is spread all over the world. It covers Europe, Asia and some parts of America and Africa. This is the most used telecommunication standard. Your GSM module is actually a low power radio transmitter and receiver. It sends out and receives radio frequency energy. When you use your GSM application, the cellular system which handles your transfers controls both the radio frequency and the power level of your cellular modem.EXPOSURE TO RF ENERGYThere has been some public concern about possible health effects from using GSM terminals. Although research on health effects from RF energy has focused on the current RF technology for many years, scientists have begun research regard-ing newer radio technologies, such as GSM. 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. If you are concerned about exposure to RF energy there are things you can do to minimize exposure. Obvi-ously, limiting the duration of your calls will reduce your exposure to RF energy. In addition, you can reduce RF exposure by operating your cellular terminal efficiently by following the guidelines below.EFFICIENT TERMINAL OPERATIONFor your GSM terminal to operate at the lowest power level, consistent with satis-factory transfer quality:Do not hold the device when the transfer is in progress. Holding the antenna affects transfer quality and may cause the GSM modem to operate at a higher power level than needed. General Safety Precautions
Page 27/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013General Safety Precautions General SafetyELECTRONIC DEVICESMost electronic equipment, for example in hospitals and motor vehicles, is shielded from RF energy. However, RF energy may affect some improperly shielded elec-tronic equipment.MEDICAL ELECTRICAL EQUIPMENTTurn your GSM option OFF in health care facilities when any regulations posted in the area instruct you to do so. Hospitals or health care facilities may be using RF monitoring equipment.AIRCRAFTTurn your GSM option OFF before boarding any aircraft.•Useitonthegroundonlywithcrewpermission.•Donotuseitintheair.To prevent possible interference with aircraft systems, Federal Aviation Administra-tion (FAA) regulations require you to have permission from a crew member to use your terminal while the aircraft is on the ground. To prevent interference with cel-lular systems, local RF regulations prohibit using your GSM option while airborne.BLASTING AREASTo avoid interfering with blasting operations, turn your GSM option OFF when in a « blasting area » or in areas posted: « turn off two-way radio ». Construction crews often use remote control RF devices to set off explosives.POTENTIALLY EXPLOSIVE ATMOSPHERESTurn your device OFF when in any area with a potentially explosive atmosphere. It is rare, but your application or its accessories could generate sparks. Sparks in such areas could cause an explosion or fire resulting in bodily injuries or even death. Areas with a potentially explosive atmosphere are often, but not always, clearly marked. They include fuelling areas such as petrol stations; below decks on boats; fuel or chemical transfer or storage facilities; and areas where the air contains chemicals or particles, such as grain, dust, or metal powders.
Page 28/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Graphical SymbolsNote Instructions for UseCaution! General warning signSwitch the device ON and OFFYear of productionManufacturerApplied Part of Type BFDisposal in compliance with WEEEBarometric pressure limitsIP 22 Protection against intrusion of solid objects with a diameter ≥ 12,5mm; dripping water when tilted up to 15°SN Serial NumberCE 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 onlyCAUTION: FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.Possible source of interferenceGeneral Safety Precautions
Page 29/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013The typeplate can be found at the rear side of the device.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.“ “This device complies with Part 15 of the FCC Rules. Operation is subjected to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including that may cause undesired operation.“This device contains FCC-IDs POOWML-C46, 2AAUFAM3G01.Information to the User related to the optional GSM module:Changes or modifications on the radiator not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined 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 technician for help.This device complies with Industry Canada licence-exempt RSS standard(s). Opera-tion is subject to the following two conditions: (1) this device may not cause inter-ference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux ap-pareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.IC:11335A-AM3G01General Safety Precautions
Page 30/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Frequency band Transmission frequency rangeOutput GainGSM 850 824 to 849 MHz 1.70 W -2.9 dBiE-GSM 900 880 to 915 MHz 0.86 W -8.5 dBiDCS 1800 1710 to 1785 MHz N/A -2.7 dBiPCS 1900 1850 to 1910 MHz N/A -3.0 dBiLiteratureMedical Device Directive (Medical Devices Act = Medizinproduktegesetz – MPG, valid in Germany, only)EN 60601-1 Medical Electrical Equipment Part 1: General Requirements for SafetyEN60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsEN 62353 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipmentDIN VDE 0100 Part 710 (IEC 60364-7-710) Electrical installations of buildings - Part 7- 710: Requirements for special installations or locations - Medical locationsReference source:VDE-Verlag GmbH, Bismarckstr. 33, 10625 Berlin or Merianstrasse 29,63069 Offenbach, Germany, E-Mail: kundenservice@vde-verlag.de Beuth VerlagGmbH, Burggrafenstraße 6, 10787 Berlin, E-Mail: info@beuth.deThe safety precautions and operational procedures indicated in this chapter refer to Germany. Different regulations and standards may apply in other countries.General Safety Precautions
Page 31/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013General Safety Precautions Notes on EMC according to EN60601-1-2The use of accessories not recommended by ERT may result in an increased elec-tromagnetic radiation or a reduced interference immunity of the AM3 GSM.Guidance and Manufacturer‘s Declaration – Electromagnetic EmissionsThe AM3 GSM is intended for use in the electromagnetic environment specied below. The customer or the user of the AM3 GSM should ensure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissions CISPR 11 Group 1 Class B The AM3 GSM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment.RF emissions CISPR 11 Group 1 Class B The AM3 GSM 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.Harmonic emissionsIEC 61000-3-2Not applicableVoltage uctuations/icker emissions IEC 61000-3-3Not applicable
Page 32/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Guidance and Manufacturer‘s Declaration – Electromagnetic ImmunityThe AM3 GSM is intended for use in the electromagnetic environment specied below. The customer or the user of the AM3 GSM should ensure that it is used in such an environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-26 kV contact 8 kV air 6 kV 8 kVFloors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/ burstIEC 61000-4-42 kV for power supply lines1 kV for input/output lines2 kV1 kVMains power quality should be that of a typical commercial or hospital environment.SurgeIEC 61000-4-51 kV differential mode2 kV common mode1 kVNot applicableMains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11< 5 % UT (> 95 % dip in UT) for 0.5 cycle40 % UT (60 % dip in UT) for 5 cycles70 % UT (30 % dip in UT) for 25 cycles< 5 % UT (> 95 % dip in UT) for 5 s< 5 % UT (> 95 % dip in UT) for 0.5 cycle40 % UT (60 % dip in UT) for 5 cycles70 % UT (30 % dip in UT) for 25 cycles< 5 % UT (> 95 % dip in UT) for 5 sMains power quality should be that of a typical commercial or hospital environment. If the user of the AM3 GSM requires continued operation during power mains interruptions, it is recommended that the AM3 GSM be powered from an uninterruptible power supply or a batteryPower frequency (50/60 Hz) magnetic eldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE UT is the A.C. mains voltage prior to application of the test level.General Safety Precautions
Page 33/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013General Safety Precautions Guidance and Manufacturer‘s Declaration – Electromagnetic ImmunityThe AM3 GSM is intended for use in the electromagnetic environment specied below. The customer or the user of the AM3 GSM should ensure that it is used in such an environment.Immunity test IEC 60601 test level Compliance levelElectromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of the AM3 GSM, including cables, that the recommended separation distance calculated from the equation applicable to the frequency of the transmitter:Recommended protection distance:Conducted RFIEC 61000-4-6 3 Vrms150 kHz to 80 MHz 3 Vrms d = 1.17 1/V * √PRadiated RFIEC 61000-4-3 3 V/m80 MHz to 2,5 GHz 3 V/m d = 1.17 m/V * √P for 80 MHz to 800 MHzd = 2,33 m/V * √P for 800 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) acc. to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compli-ance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reections from structures, objects and people.a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theroretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the AM3 GSM is used exceeds the applicable RF compliance level above, the AM3 GSM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AM3 GSM.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Page 34/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Recommended Separation Distance between portable and mobileRF Communications Equipment and the AM3 GSMThe AM3 GSM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AM3 GSM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF commnucations equipment (transmitters) and the AM3 GSM as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHzd = 1.17 1/V * √P80 MHz to 800 MHzd = 1.17 m/V * √P800 MHz to 2,5 GHzd = 2.33 m/V * √P0.01 Not applicable 0.12 0.230.1 Not applicable 0.37 0.741Not applicable 1.17 2.3310 Not applicable 3.7 7.37100 Not applicable 11.7 23.3For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2 These guidelines may not be apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people. General Safety Precautions
Page 35/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Return of Goods in Medical InstitutionsRecommendations for action -forallstaffmembershavingcontactwithpotentiallycontaminatedreturns.Returns or returned goods are all products returned to the producer or the supplier, irrespective of whether or not they have been used; e.g. due to complaints, for repair, or for maintenance. Those products might have had contact with biological substances or highly active pharmaceuticals (e.g. cytostatics, radioactive medicines) and could be contaminated by them. If in doubt, the goods to be returned should be treated as contaminated products.Due to infectious agents, pathogens or pharmaceuticals contaminated goods pose a potential hygienic risk to all persons having contact with the returns.This leaflet shall minimize the potential hygienic risk when handling returned goods. Among other things, this information is based on the legal standards of the Biostoff-Verordnung (= Biological Substances Regulation) and the Employment Protection Act (both valid in Germany). A more detailed reference list of applicable rules and regulations can be obtained from the BVMed (info@bvmed.de). In order to protect your and our employees who handle contaminated parts and to optimally examine such parts, you should consider the following:1. Assessment of returns before reshipmentIrrespectively of whether or not a contamination risk is known, products which had direct or indirect contact with biological working substances (e.g. blood, secretions or other body fluids) or with highly active pharmaceuticals (e.g. gloves of the clinical or surgical staff) should be considered potentially dangerous to health.According to the regulation on biological substances, substances of risk group 3 can cause severe illness in humans and pose a serious risk to staff members (e.g. tuberculosis or hepatitis). Substances of risk group 4 cause severe illness in humans and pose a serious risk to staff members (e.g. Ebola or smallpox). Regarding national and international regulations for the transport of potentially infectious substances (ADR, IATA-DGR) the risk groups 2 (e.g. staphylococcus aureus) and 3 defined by the Biological Substances Regulation are classified as Transport Category B. Products which are potentially contaminated by biological working substances of risk group 4 according to the regulation on biological substances as well as products which are potentially contaminated by pharmaceuticals posing a serious risk to health (e.g. X-ray contrast agents and cytostatics) must not be returned to the producer.
Page 36/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013The following applies for products which are potentially contaminated by biological working substances of risk group 3 and 2 according to the regulation on biological substances and which are thus classified as Transport Category B:Please contact ERT before returning the goods and refer to the regulations for the transport of dangerous goods. 2. CleaningIf the products had contact with biological working substances (for example blood or other body fluids), they have to be cleaned and disinfected in a combined cleaning and disinfection procedure, unless a differing agreement has been made with ERT.As a rule, the products also have to be cleaned in order to minimize adhesions and bacterial contamination. Unless body fluids, body tissue or contrast agents etc. have caused the product defective, deposits and adhesions should be removed carefully without damaging or altering the product, if possible. For this, refer to the notes on the preparation of products.Products which have been contaminated by highly active pharmaceuticals have to be cleaned appropriately with tap water. If in doubt, contact ERT for guidance on the further actions!3.Disinfection/SterilizationAfter cleaning, the products have to be disinfected and/or sterilized (only if permitted for this medical product) in order to avoid endangering of your and our employees.If in doubt or in case of suspected material incompatibility, please consult ERT.4. PackagingTo avoid any contamination, the cleaned and disinfected product has to be packed as follows:a) Put it into a sealable primary packing.Parts with sharp edges need to be packed particularly safely.b) Put the primary packing in a waterproof secondary packing (if possible use hard packing material).c) Pack the secondary packing with a neutral packing material. For “Packaging and labeling of non-contaminated products“: see point 6.
Page 37/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV20135. LabelingIf a concrete risk of infection (e.g. HIV, Hepatitis B or C) is known to be present, this risk has to be noted on the packing of the returned goods and/or in the accom-panying documents.For “Packaging and labeling of non-contaminated products“: see point 6.6.Packagingandlabelingofnon-contaminatedproductsIf the procedures described under point 2 and 3 are not applied, the contaminated product has to be returned in a combined packing complying with the packaging instruction P 650 ADR after contacting ERT, if necessary. Proceed as follows:a) Put the product into a liquid-tight, sealable packing (e.g. tear-proof plastic bag) (primary packing)b) Put the primary packing into a (if possible, liquid-tight) protective packing (secondary packing); for liquid materials, insert an adequate amount of absorbing material between the primary and the secondary packing.c) Pack the secondary packing with an additional outer packaging (padded envelope or cardboard box).d) Label the outer packaging with the corresponding UN no. 3373 for diagnostic or clinical samples and add the note:“Biologischer Stoff, Kategorie B/Biological Substance, Category B“7.DispatchPlease note that non-decontaminated returns with suspected pathogens of risk group 3 are excluded from mailing. Diagnostic or clinical samples of UN no. 3373 which have been packed according to packing instruction P 650 are not subject to any further regulations on the transportation of dangerous goods and may be transported by a forwarding agent or a parcel service. For this purpose use the accompanying shipping documents of the forwarding agent/carrier containing the corresponding valid transportation regulations, e.g. GGVSE (Road and Railway Dangerous Goods Regulation). The product is then dispatched to the address provided by the manufacturer. Address:eResearchTechnology GmbHSieboldstrasse 397230 Estenfeld, GermanyTel: +49 9305 720-9891www.ert.com
Page 38/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Certificate of HygieneThis certicate must be attached to ANY product complaint, ANY return of medical products and accessories, ANY repair order and ANY return of studies.Name of product: REF (ERT item no.): LOT (batch no.): It is herewith conrmed by signature that (please mark appropriate box): the enclosed medical product had no contact with blood or other body uids so that it is hygienically safe. the enclosed medical product had contact with blood or other body uids during its use. The product has been cleaned and decontaminated as follows: Disinfection by wiping all accessible surfaces with Disinfectant: Concentration: Reaction time:  Other procedure (please indicate): Steam sterilization (3 minutes at 134 °C or 15 minutes at 121 °C)  the enclosed medical product could not be decontaminated. Reason: Send returns to the following address:eResearchTechnology GmbH Abteilung WareneingangSieboldstrasse 397230 EstenfeldGermanySender‘s signature and address:
Page 39/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Technical DataPrinciple:Determination of respiratory flow and volume via exchangeable infrared rotary flow sensor.Range:FlowVolume0 - 840 liters/minute0.5 - 8 litersAccuracy:FlowVolume± 5 % or ± 20 L/min± 3 % or ± 0.05 litersStorage capacity: 1200 measurements, 400 sets of questionnaires (max. 20 questions each)Power supply: LI-ION Polymer battery 3.7 V, 1700 mAh Battery will last under standard operating conditions for about 40 days. Full charging: 2 hDimensions:Length x width x heightWeight112 x 82 x 37 mm120 g (batteries included)Ambient conditions:TemperatureRelative humidityBarometric pressure+10 °C to +40 °C15 % to 95 %, not condensing700 to 1060 hPaTransport and storage conditions:TemperatureRelative humidityBarometric pressure -20 °C to +50 °C15 % to 95 %, not condensing600 to 1200 hPaMoisture protection: IP 22Medical classification: Active Medical Device Class IIaApplied part: Type BF (whole device)Protection class: Battery DeviceMode of operation: Continuous operationMax. resistance: 70 Pa/L/s at 14 L/s
Page 40/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013Interface: RS-232 (used in the modem mode and for production)USB 2.0 Bluetooth 2.0 (no EDR) GSMMedical Power supply (battery charging): WR9QA1200MUNMRVG2773 Model GTM41134-0605 Input 100-240 Vac, 47 - 63 Hz, 0.3A Output 5 V, 1.2 AThe expected operational lifetime of the AM3 is 5 years. AM corresponds to the recommendations of ATS/ERS.
Page 41/42Peak Flow Meter AM3 - Instructions for Use for Trial xxxVersion 00.03 • Date 04NOV2013IndexCCase 20Confirmation 8DDeclaration of Conformity 7Display 8Disposable Mouthpiece 20FFEV1 13FVC 13GGSM 4, 17, 26, 27, 29, 40IInstalling 17International Support 5Investigator Mode 10LLiterature 30NNotes on EMC 31OOff 8Optional Measurements 14PPeak Flow Meter 8PEF 13PEF Measurements 13RReleaser 8Return of Goods 35Rotary Flow Sensor 20SSafety Precautions 22Scheduled Session 14Scroll down 8Scroll up 8Sealing cap 11Sensor 20Settings 16Subject Mode 10TTechnical Data 39Toll-free hotline 6UUnscheduled/Optional Measurements 14
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