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NDD EasyOne, Operator'S Manual

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Preface

Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect

© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

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4

 

1

Preface

1.1

Revision history of the 

EasyOne Air

 Operator’s Manual

1.2

Identification and revision of the 

EasyOne Air

 spirometer

This revision V1.1 of the 

EasyOne Air

 Operator’s Manual applies to 

EasyOne Air

 with a serial number greater than 1,000,000 and with a firmware 

version greater than V1.9.0.
If you are in doubt whether this revision of the Operator’s Manual applies to 
your particular 

EasyOne Air

 sensor, please contact the 

ndd

 Servicing 

Department.
You can find the most recent revision of this Operator’s Manual on the 

ndd

 website.

Contact information, 4

On www.ndd.ch
For the US, on www.nddmed.com

1.3

Version history of the 

EasyOne Connect

 PC software

A comprehensive version history of 

EasyOne Connect

 is available on the 

ndd

 website. Simply search for “version history” on the 

ndd

 website.

EasyOne Air

 requires 

EasyOne Connect

 V3.0 or later.

On www.ndd.ch
For the US, on www.nddmed.com

1.4

Intended use of the 

EasyOne Air

 spirometer

The 

EasyOne Air

 spirometer is intended for prescription use only to conduct 

diagnostic spirometry testing of adults and pediatric patients over 4 years 
old. The 

EasyOne Air

 spirometer is used by general practitioners, specialists, 

and health care professionals, in hospitals and clinics, in pharmacies, and in 
clinical settings in occupational medicine.

Revision date

Version

Description

10 April 2018

V1.1

Revised version with minor changes

27 February 2017

V01

Initial release for market launch

Revision history of the 

EasyOne Air

 Operator’s Manual

Summary of Contents for EasyOne

Page 1: ...new diagnostic design 9000007_01 ndd Medizintechnik AG Technoparkstrasse 1 8005 Zurich Switzerland www ndd ch EasyOne Air Operator s Manual V1 1 ...

Page 2: ...w ndd ch For the US on www nddmed com 1 3 Version history of the EasyOne Connect PC software A comprehensive version history of EasyOne Connect is available on the ndd website Simply search for version history on the ndd website EasyOne Air requires EasyOne Connect V3 0 or later On www ndd ch For the US on www nddmed com 1 4 Intended use of the EasyOne Air spirometer The EasyOne Air spirometer is ...

Page 3: ...le place 1 7 Application Notes for further information You can find further information on specialized topics in Application Notes on the ndd website http AppNotes ndd ch For the US http AppNotes nddmed com 1 8 Legal information Due to continuing product innovation specifications in this manual are subject to change without notice ndd Medizintechnik AG Zurich Switzerland All rights reserved No par...

Page 4: ... Canada see RSS Gen General Requirements for Compliance of Radio Apparatus 1 10 Contact information 1 11 Product registration Registering EasyOne Air facilitates the handling of warranty claims To register EasyOne Air go to the ndd website http reg ndd ch For the US http reg nddmed com 1 12 Disposal ndd Medizintechnik AG ndd Medical Technologies Technoparkstrasse 1 300 Brickstone Square Suite 604 ...

Page 5: ... Using this Operator s Manual 3 Application Notes for further information 3 Legal information 3 About electromagnetic interference 4 Contact information 4 Product registration 4 Disposal 4 2 Safety information 11 Classification 11 General safety information 11 Safety information regarding electromagnetic compatibility 14 About requirements for connections to external devices 15 List of equipment i...

Page 6: ...sword expiration 40 About periodical software updates and patches 41 About backups 41 Escalating in case of a security breach 41 Dealing with a lost or stolen EasyOne Air or PC 42 Using EasyOne Air securely general guidelines 42 6 Connectivity and data exchange 44 About connectivity between EasyOne products 44 About integration of EMR systems 45 About supported EMR standards 45 About possible work...

Page 7: ...nnecting EasyOne Air to EasyOne Connect 63 Performing a complete test using EasyOne Connect together with EasyOne Air 64 Performing a bronchial provocation test using EasyOne Connect in combination with EasyOne Air 71 About interpreting results 72 List of quality messages and quality grades 73 About quality messages and quality grades 73 Quality messages for trials 73 List of quality grades for te...

Page 8: ...ively and entering comments with EasyOne Connect 90 About exporting comprehensive data from EasyOne Connect 91 About exporting XML from EasyOne Connect 91 About exporting from EasyOne Connect to EasyWare 92 11 Configuration 93 Configuration of EasyOne Air 93 Configurations in the settings menu of EasyOne Air 93 Description of device settings of EasyOne Air 93 Description of spirometry settings of ...

Page 9: ...layout of EasyOne Connect 116 Description of printer configurations of EasyOne Connect 116 Description of environment configurations of EasyOne Connect 117 12 Calibration check 118 About calibration check with EasyOne Air 118 Performing a calibration check with EasyOne Air 120 13 Servicing and troubleshooting 122 About charging the battery of EasyOne Air 122 Checking for correct operation of EasyO...

Page 10: ...sse 1 8005 Zurich Switzerland www ndd ch 10 144 10 A Appendix 140 Electromagnetic Compatibility EMC 140 General 140 Environment 140 EMC conformance 140 Safety information 140 Compliant cables and accessories 140 Wireless module 141 Electromagnetic emission 141 Electromagnetic immunity 142 ...

Page 11: ...mplies with the IEC 60950 1 standard for the electrical safety of IT equipment Patient health hazard Inadequate qualification of personnel who operate EasyOne Air can put the patient s health at risk The patient may suffer an asthma attack or a bronchospasm while performing spirometry EasyOne Air must only be used by qualified personnel Do not leave the patient unattended while performing spiromet...

Page 12: ... the patient For preventive measures make sure that the device is not used near flamma ble gases for example anesthetic agents If not in daily use remove the battery from EasyOne Air and store the battery in the original packaging False diagnosis Environment conditions outside the range described in the specifications can cause measurement errors Use EasyOne Air only within the defined environment...

Page 13: ...the battery improperly Do not throw the battery into fire Remove the battery from the battery compartment if you do not intend to use EasyOne Air for a longer period Avoid mechanical shock to the battery If the rechargeable battery is damaged liquids from the battery must not get into contact with skin or eyes In case of contact with skin or eyes rinse thor oughly with water and consult a physicia...

Page 14: ...compatibility Influence by HF surgical equipment Electrical devices with a high RF power output during intended use e g High frequency HF surgical equipment should not be operated in parallel with EasyOne Air Portable wireless communications equipment Portable wireless communications equipment such as wireless home network devices mobile phones cordless telephones and their base stations walkie ta...

Page 15: ...are complied with The following conditions must be met All equipment operated in the patient environment must meet the requirements of IEC 60601 1 All equipment set up outside the patient environment must meet the requirements of the applicable IEC or ISO safety standards e g IEC 60950 1 Patient environment If devices that do not fulfill the requirements of IEC standard 60601 1 are operated in the...

Page 16: ...ication for the USA and Canada Medical electric equipment that includes a radio frequency transmitter and emits non ionizing radiation Manufacturer Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner In the European Union the product you have purchased should not be disposed of as unsorted municipal waste Please make use of your local WEEE col...

Page 17: ...nnect ndd Medizintechnik AG Technoparkstrasse 1 8005 Zurich Switzerland www ndd ch 17 144 25 3 First time setup 3 1 List of box contents The box contains the following items Box contents top inlay A EasyOne Flow Tube respiratory tubes B EasyOne Air spirometer A B ...

Page 18: ...r EasyOne Connect ndd Medizintechnik AG Technoparkstrasse 1 8005 Zurich Switzerland www ndd ch 18 144 25 Box contents bottom inlay A Battery B USB Bluetooth adapter C USB flash drive D 2x USB cable E Nose clip F ndd power supply G Cradle A B C D F G E ...

Page 19: ...onal movies The EasyOne Connect PC software 3 2 About compatible printers EasyOne Air can print over USB when using the cradle To print via the cradle the printer must support the protocols Direct PDF Postscript or HP PCL 3 Enhanced EasyOne Connect can use any printer that is installed on your PC To print using EasyOne Connect connect the printer to your PC and not to the cradle Description of pri...

Page 20: ...ers and net works that complies with the IEC 60950 1 standard for the electrical safety of IT equipment CAUTION ELECTRIC SHOCK PATIENT HEALTH HAZARD AND FALSE DIAGNOSIS Damage to casing or broken components may expose the patient or technician to dangerous voltage Small parts from damaged disposables can be ingested or inhaled by the patient Measurement errors can cause false diagnosis Check the d...

Page 21: ...nto the battery compartment of EasyOne Air The battery fits easily into the compartment If the battery does not seem to fit check the correct insert direction Do not apply force 4 Close and lock the battery compartment by turning the lock screw counterclockwise 5 Unpack the cradle and the USB cables 6 Turn the cradle around so that the back of the cradle is facing towards you ...

Page 22: ...h the printer PC icon b Connect the larger plug of the USB cable micro to type B to the corresponding USB port of your printer 8 If you want to connect the cradle to a PC do the following a Connect the smaller plug of the USB cable micro to type A to the left USB port of the cradle marked with the printer PC icon b Connect the larger plug of the USB cable micro to type A to a USB port of your PC Y...

Page 23: ...se 1 8005 Zurich Switzerland www ndd ch 23 144 25 9 For charging EasyOne Air always connect the ndd power supply a Plug the ndd power supply into a power outlet b Connect the cable of the ndd power supply to the right USB port of the cradle marked with the plug icon Setting up the EasyOne Air spirometer 24 ...

Page 24: ... physical components 20 1 Turn on EasyOne Air The region selection screen is displayed 2 Select your region from the world map The language selection screen is displayed 3 Select your language from the language selection list 4 Select the date and time format 5 Enter the date and time and choose Next If the battery is removed for more than 8 hours your need to reenter date and time Configuration o...

Page 25: ...ne Air and EasyOne Connect and per form a calibration check Calibration check 118 Checking for correct operation of EasyOne Air 122 1 Connect the USB flash drive from the box contents to your PC 2 Choose the file SmartInstaller exe The User Account Control of Microsoft Windows is displayed and asks for confirmation 3 In the User Account Control window choose Yes The ndd SmartInstaller is displayed...

Page 26: ...ntroduction 4 1 Introduction to the EasyOne Air spirometer 4 1 1 Overview of EasyOne Air The EasyOne Air spirometer Top view of EasyOne Air Bottom view of EasyOne Air A EasyOne Flow Tube holder B Touchscreen C Handles D Power button A Speaker B USB port to connect to the cradle C Lock screw for battery compartment D Battery compartment A B D C C A C D B ...

Page 27: ...syOne Flow Tube respiratory tube for single patient use The EasyOne Flow Tube respiratory tube To ensure hygienic testing the EasyOne Flow Tube respiratory tube is a disposable for single patient use EasyOne Air recognizes the correct position of the EasyOne Flow Tube in the EasyOne Flow Tube holder and gives feedback if the EasyOne Flow Tube is not placed correctly The EasyOne Flow Tube is design...

Page 28: ...e tapped is highlighted as visible feedback To scroll through lists a scroll bar is displayed on the right side of lists To move a slider on the touchscreen drag your finger across the touchscreen Using the touchscreen with gloves You can use the touchscreen wearing disposable gloves made of any material Standard disposable gloves used in hospitals and general practioners offices work fine with th...

Page 29: ...en displays the following icons This icon is a shortcut to the most commonly performed test the FVC test In the more menu you can choose from all available tests In the reports menu you have access to the reports in chronological order In the patients menu you have access to patient data and also to the reports which are sorted by patient here In the tools menu you can configure EasyOne Air and pe...

Page 30: ...h the delete patient button you can delete a patient from the database With the edit patient data button you can edit patient data In the history menu you have access to patient data and results With the export button you can export patient data and results In the settings menu you have access to various settings that are listed in the table below In the calibration check menu you can perform cali...

Page 31: ...device settings like speaker volume empirical or metric units settings date and time settings or Bluetooth settings In the spirometry settings menu you have access to spirometry settings like predicted normal values system interpretation or the automatic quality control setting In the display settings menu you have access to settings like language date and time format or settings for how results a...

Page 32: ...nt Indicates a connection to a printer Indicates a connection to a PC Indicates that an SD memory card is inserted Indicates that charging level of the battery is very low Indicates that EasyOne Air is connected to the ndd power supply and currently charging But the charging level is still low Indicates that EasyOne Air is connected to the ndd power supply and currently charging The charging level...

Page 33: ... the same features as EasyOne Air to perform spirometry to work with patient data or to evaluate results as well as some additional features EasyOne Connect is especially helpful to work with patient data and to evaluate results because you can use a full size PC monitor and keyboard If you want to perform spirometry with EasyOne Air stand alone for example off site EasyOne Connect enables you to ...

Page 34: ...nnect The main menu of EasyOne Connect The main menu displays the following icons In the patients menu you have access to patient data and also to the reports In the test menu you can choose from all available tests In the history menu you have access to the reports in chronological order In the orders menu you have access to orders for spirometry tests from your EMR system This icon is only displ...

Page 35: ... demographic data choose this area To open the PDF file of this Operator s Manual choose With the menu area you can navigate back to the main menu The label and function of this area varies between menus Term Definition test Short for spirometry test A test is an examination that is defined by the breathing maneuver that the patient performs and by the parameters that are calculated from the measu...

Page 36: ...T t0 MVV Maximum voluntary ventilation test MVV MVV6 MVVtime Rf SVC Slow vital capacity test ERV IC IRV Rf VC VCex VCin VCmax VT Tests Parameter Parameter description Unit BEV Back extrapolated volume L BTPSex BTPS factor used for expiration BTPSin BTPS factor used for inspiration EOTV End of test volume L ERV Expiratory reserve volume L f Breathing frequency 1 min FEF10 Forced expiratory flow at ...

Page 37: ... L FIVC Forced inspiratory vital capacity L FVC Forced expiratory vital capacity L FVC6 Forced expiratory vital capacity after 6 seconds L IC Inspiratory capacity from end of tidal breathing L IRV Inspiratory reserve volume L Lung Age calculated age of the average healthy individual who would perform similar to tested patient on spirometry Years MEF20 Mean expiratory flow at 80 of vital capacity s...

Page 38: ...seconds s PEF Peak expiratory flow L s PEFT Time to peak flow s PIF Peak inspiratory flow L s Rf Respiratory frequency 1 min t0 Back extrapolated start time of the trial s VC Vital capacity from slow expiration L VCex Expiratory vital capacity from slow expiration L VCin Inspiratory vital capacity from slow inspiration L VCmax Highest VC value from all trials of one test L VT Tidal volume L Parame...

Page 39: ...nt conditions can be converted from ATPS EHR Electronic health record synonymous to EMR used in EMR systems EMC Electromagnetic compatibility EMR Electronic medical record synonymous to EHR used in EMR systems EMR system Computer software for handling electronic medical records ERS European Respiratory Society GDT Gerätedatentransfer German EMR standard GLI Global Lung Function Initiative GOLD Glo...

Page 40: ...to connect EasyOne Connect to an SQL server based database 5 2 About password policies and password expiration You can use a combination of user name and password in order to control access to EasyOne Connect It is the responsibility of the operating institution to apply the appropriate password policies for example password strength and password renewal intervals EasyOne Connect does not include ...

Page 41: ...onnect is shut down In addition the manufacturer recommends that you regularly backup the database manually to a different storage device and that you store this additional backup in a separate location When using an SQL server based database In this case no automatic backup is performed It is the operating institution s responsibility to perform backups of the SQL server regularly Utilities Confi...

Page 42: ...nnect is installed on to the ndd Servicing Department The ndd Servicing Department will ensure that your EasyOne Air or your installation of EasyOne Connect is not unlocked unintentionally by ndd staff for anyone else but you Contact information 4 5 7 Using EasyOne Air securely general guidelines The manufacturer strongly recommends that you follow these guidelines at all times 1 Activate user han...

Page 43: ... period that you have set EasyOne Air is locked and users must log in again 3 Only use network file transfer pdf HL7 XML etc in trusted and secured network environments 4 In case you use an SQL server based database it is the operating institution s responsibility to use appropriate measures to protect the SQL server as well as the communication channel Generally SQL servers provide functionality ...

Page 44: ...ll EasyOne products can connect to a shared comprehensive database through the EasyOne Connect PC software The EasyOne Pro Respiratory Analysis System can connect to this shared database independently To enable connectivity between EasyOne products the manufacturer recommends to set up an SQL server based database After you have configured an SQL server based database you can review patient data a...

Page 45: ...One Connect and EasyOne Pro LAB have EMR plug ins preinstalled HL7 Health Level 7 is an international EMR standard GDT Gerätedatentransfer is a German EMR standard XML file exchange With this plug in you can connect your EMR system using a simple and configurable XML file exchange Operator s Manual of your EMR system 6 2 2 About possible workflows with your EMR system There are two general possibi...

Page 46: ...yOne Air to process orders When you synchronize EasyOne Air with EasyOne Connect orders from your EMR system are also synchronized with EasyOne Air On EasyOne Air you can select orders from your EMR system in the orders menu 6 2 4 Overview of the integration process Please contact the ndd Servicing Department to start an integration project The integration process consists of the following steps 1...

Page 47: ...ile based message exchange Message acknowledgments Sending discrete data Sending reports Application Note EasyConnect HL7 Connector Application Notes for further information 3 Operator s Manual of your EMR system Processing orders from your EMR system 48 Sending individual test results to your EMR system 50 6 2 5 2 About the GDT plug in With the GDT plug in you can only use the direct start workfl...

Page 48: ...nding discrete data Sending reports Software Developer Guide SDK ndd EMR plug in 6 2 5 4 About custom plug ins ndd offers a software development kit that enables third parties and customers to develop customized EMR plug ins to interface with any EMR system Software Developer Guide SDK ndd EMR plug in 6 2 6 Working with your EMR system 6 2 6 1 Processing orders from your EMR system If you have int...

Page 49: ...tem All plug ins support this workflow Prerequisite You have configured any one of the available plug ins About the HL7 plug in 47 About the GDT plug in 47 About the XML file exchange plug in 48 About custom plug ins 48 1 Launch your EMR system 2 Choose the external devices menu 3 Select either EasyOne Connect or EasyOne Pro LAB and confirm EasyOne Connect is launched automatically In EasyOne Conn...

Page 50: ... In your EMR system confirm the received test results and proceed as required Performing spirometry 51 6 2 6 3 Sending individual test results to your EMR system It is possible to send individual test results to your EMR system even if that test is not part of an order from the EMR system This enables you to work without orders from your EMR system and to only send test results to your EMR system ...

Page 51: ...alone Yes No Instruct the patient Performing spirometry Ö7 2 Summary screen is displayed Ö7 5 3 Enter patient data Select existing patient Add trial add post or create new test Previous test performed within 24 h Choose a test Ö7 5 1 Ö7 5 2 Add a new patient Prepare EasyOne Flow Tube Set baseline Patient performs breathing maneuver Dispose of EasyOne Flow Tube Print report No No Yes Yes Quality me...

Page 52: ...rometry test Explaining spirometry Explain that the purpose of the test is to determine how much air a person s lungs can hold and how quickly that air can be expelled with a forceful maximum effort Since the spirometry test requires active participation on the part of the patient it is very important to demonstrate the breathing maneuver to the patient The most commonly used spirometry test is th...

Page 53: ...Utilities Configuration Test General Test Procedure Breathing maneuvers for all available tests 75 Avoiding contamination while performing spirometry 80 Test Procedure 108 7 3 About quality messages for trials and quality grades for tests Quality messages To obtain reliable results an acceptable quality of the trials is necessary The quality of a trial depends on cooperation of the patient and thi...

Page 54: ...tand alone 7 5 1 Choosing a test and adding a new patient If you wish to register the patient to be tested immediately before conducting the test you can start by manually adding a new patient 1 If you want to perform an FVC test choose The patient selection list is displayed 2 If you want to perform any other test do the following a Choose b Choose one of the test icons 3 Select Add Patient A dia...

Page 55: ...t to perform an FVC test choose The patient selection list is displayed 2 If you want to perform any other test do the following a Choose b Choose one of the test icons The patient selection list is displayed 3 Select a patient If the patient has performed a test within the previous 24 hours the question window is displayed Proceed with step 4 If the patient has not performed a test before or not ...

Page 56: ...screen displays common data about the patient that you have entered before You can edit the data and for example add the following medical data about the patient Asthma status Dyspnea status Smoker status Cigarettes per day Smoke years Profession Occupation exposure Diagnosis In addition you can access reports of previous tests of the patient Performing a complete test using EasyOne Air stand alon...

Page 57: ...euse the EasyOne Flow Tube contamination from an infected patient can be deposited on the EasyOne Flow Tube The contamination from an in fected patient can later be passed on to the next patient who is tested You cannot clean or disinfect the EasyOne Flow Tube in any way The EasyOne Flow Tube is for single patient use only Always replace the EasyOne Flow Tube with a new one between patients or whe...

Page 58: ...visually check the wrapper of the new EasyOne Flow Tube again for defects Visually check the EasyOne Flow Tube for defects before use and between trials Before you use EasyOne Air with the patient make sure that there are no obvious or wet residues on EasyOne Air from prior cleaning To prepare the test 1 Partly unwrap the EasyOne Flow Tube For hygiene reasons grip the partly unwrapped EasyOne Flow...

Page 59: ...er as depicted below but keep the partly unwrapped wrapper on the mouthpiece of the EasyOne Flow Tube The shape of the EasyOne Flow Tube and the EasyOne Flow Tube holder guide the orientation of the EasyOne Flow Tube You can only insert the EasyOne Flow Tube fully if it is positioned correctly When you insert the EasyOne Flow Tube avoid direct sunlight as it can interfere with the automatic recogn...

Page 60: ...t to perform an FVL test an MVV test or an SVC test attach the nose clip to the patient s nose 8 Hand EasyOne Air to the patient 9 Tell the patient to breathe at rest The following procedure To perform the FVC breathing maneuver represents the breathing maneuver for the FVC test as an example If you want to perform any other test replace the procedure To perform the FVC breathing maneuver with the...

Page 61: ... the patient to take the EasyOne Flow Tube out of the mouth and to breathe normally again If the trial is acceptable the green quality message is displayed If the trial is not acceptable a yellow or red quality message is displayed suggesting how to improve the breathing maneuver To add trials 1 If you want to look at the details of this trial choose Data The report screen is displayed 2 Choose Ne...

Page 62: ...ician Always wear disposable gloves Between patients always exchange disposable gloves clean EasyOne Air and disinfect hands Electric shock failure of EasyOne Air and false diagnosis Make sure that no fluid penetrates the EasyOne Flow Tube holder or the inside of EasyOne Air while cleaning To clean EasyOne Air do not fully dip EasyOne Air into any fluid To clean EasyOne Air and to disinfect your h...

Page 63: ... If EasyOne Air is directly connected to a PC over USB performing tests is not possible Leakage currents could harm the patient Connect EasyOne Air to your PC wirelessly only 1 On EasyOne Air choose 2 Select the Bluetooth check box and keep the menu open EasyOne Air is discoverable over Bluetooth by other devices 3 On your PC navigate to the Bluetooth menu to add Bluetooth devices Where to find th...

Page 64: ... contamination from an infected patient can be deposited on the EasyOne Flow Tube The contamination from an in fected patient can later be passed on to the next patient who is tested You cannot clean or disinfect the EasyOne Flow Tube in any way The EasyOne Flow Tube is for single patient use only Always replace the EasyOne Flow Tube with a new one between patients or when performing spirometry on...

Page 65: ...visually check the wrapper of the new EasyOne Flow Tube again for defects Visually check the EasyOne Flow Tube for defects before use and between trials Before you use EasyOne Air with the patient make sure that there are no obvious or wet residues on EasyOne Air from prior cleaning To prepare the test 1 Partly unwrap the EasyOne Flow Tube For hygiene reasons grip the partly unwrapped EasyOne Flow...

Page 66: ...nlight as it can interfere with the automatic recognition of the EasyOne Flow Tube 3 On the main menu of EasyOne Connect choose Patients 4 Select the patient that you want to test 5 At the bottom of the screen choose Test 6 Choose the test that you want to perform 7 If the environment conditions screen is displayed enter the current values and choose Confirm For the FVL test the MVV test and the S...

Page 67: ...eline seal off one end of the EasyOne Flow Tube with the wrapper to avoid air flow 10 Choose OK In the colored status bar Setting baseline Avoid flow is displayed After the baseline has been set Start test is displayed 11 Remove the wrapper from the EasyOne Flow Tube 12 If you want to perform an FVL test an MVV test or an SVC test attach the nose clip to the patient s nose 13 Hand EasyOne Air to t...

Page 68: ... manual test stop or automatic test stop under Utilities Configuration Test General Test Procedure The test result is displayed 5 Tell the patient to take the EasyOne Flow Tube out of the mouth and to breathe normally again If the trial is acceptable the green quality message is displayed If the trial is not acceptable a yellow or red quality message is displayed suggesting how to improve the brea...

Page 69: ... Always wear disposable gloves Between patients always exchange disposable gloves clean EasyOne Air and disinfect hands Electric shock failure of EasyOne Air and false diagnosis Make sure that no fluid penetrates the EasyOne Flow Tube holder or the inside of EasyOne Air while cleaning To clean EasyOne Air do not fully dip EasyOne Air into any fluid To clean EasyOne Air and to disinfect your hands ...

Page 70: ...eport on the printer that you have configured choose Print from the top of the screen c To export the report as a PDF file or to select a different printer choose Print Menu from the top of the screen d To return to the test result screen choose Return from the menu bar 5 To return to the main menu choose Main Menu from the menu bar List of cleaning solutions for EasyOne Air 81 About interpreting ...

Page 71: ...start with the test Utilities Configuration Test Provocation 115 About preparation of spirometry and instructions for the patient 52 Performing the breathing maneuver for the FVL test 76 WARNING PATIENT HEALTH HAZARD Performing provocation tests can cause an asthma attack or bronchospasm Familiarize yourself with appropriate medication documentation guidelines procedures and contraindications as t...

Page 72: ...e the procedure To perform the FVC breathing maneuver with the breathing maneuver for the FVL test Breathing maneuvers for all available tests 75 You can configure whether to use the FVC test or the FVL test for forced spirometry under Utilities Configuration Test FVC FVL Type The EasyOne Flow Tube is a single patient use disposable and hygienically packaged Visually check the wrapper of a new Eas...

Page 73: ...t The trial ranks are given in numbers 1 2 3 etc and may be crossed out 7 8 3 List of quality grades for tests Quality grades help you as the operator to assess the quality of a completed test Quality grades for the FVC test the FVL test and the OSHA test Rating Criteria A At least 3 acceptable trials for age 6 and under 2 acceptable AND the difference between the best two FEV1 and FVC values is e...

Page 74: ... between the best two FEV1 and FVC values is equal to or less than 100 mL or 5 of FVC or FEV1 respectively F No acceptable trial available Quality grades for the FVC test the FVL test and the OSHA test Rating Criteria A At least 3 acceptable trials AND the difference between the best VC values is equal to or less than 150 mL B At least 2 acceptable trials AND the difference between the best VC val...

Page 75: ...ing maneuver the patient must exhale with a forceful maximum effort 1 Tell the patient to breathe at rest 2 Tell the patient to fill the lungs completely 3 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal the lips around the EasyOne Flow Tube The patient must not block the opening with the tongue or teeth or bite down excessively on the EasyOne Flow Tube 4 Tell the patient...

Page 76: ...e Flow Tube into the mouth and to seal the lips around the EasyOne Flow Tube The patient must not block the opening with the tongue or teeth or bite down excessively on the EasyOne Flow Tube 4 Tell the patient to exhale as hard and as fast as possible and to continue blowing out until the lungs are completely empty 5 Tell the patient to keep the EasyOne Flow Tube in the mouth to breathe in and to ...

Page 77: ...t configuration for predicted values for adults is NHANES III To use predicted values for adults according to Knudson 1976 you need to change the configuration in the following menu Predicted set 1 According to these requirements the reports contain the following information The best three tests and volume time curves are saved and printed The curves are printed in large in validation size There i...

Page 78: ...st enter the environment temperature within 1 C or 1 8 F accuracy 1 Tell the patient to breathe at rest 2 Tell the patient to fully exhale 3 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal the lips around the EasyOne Flow Tube The patient must not block the opening with the tongue or teeth or bite down excessively on the EasyOne Flow Tube 4 Tell the patient to fully inhal...

Page 79: ...d the EasyOne Flow Tube The patient must not block the opening with the tongue or teeth or bite down excessively on the EasyOne Flow Tube 3 Tell the patient to continue breathing at rest Typically three to five breaths are required Tidal Breathing is displayed 4 When Start test is displayed and when the steady tidal acoustic signal sounds tell the patient to fully inhale and fully exhale Instead t...

Page 80: ...tamination from an in fected patient can later be passed on to the next patient who is tested You cannot clean or disinfect the EasyOne Flow Tube in any way The EasyOne Flow Tube is for single patient use only Always replace the EasyOne Flow Tube with a new one between patients or when performing spirometry on yourself Only use an original EasyOne Flow Tube by the manufacturer 1 To protect yoursel...

Page 81: ...pe the handles and the display of EasyOne Air b Put down EasyOne Air c Take off or change the disposable gloves and disinfect your hands before you put on new disposable gloves Calibration check 118 9 2 List of cleaning solutions for EasyOne Air Do not use just any cleaning solution for EasyOne Air Only use the listed cleaning solutions CAUTION ELECTRIC SHOCK FAILURE OF EASYONE AIR AND FALSE DIAGN...

Page 82: ...sly Double check that you have entered the patient data correctly 10 1 Working with patient data and reports on EasyOne Air 10 1 1 Adding a patient to the database on EasyOne Air 1 Choose 2 Choose The add patient dialog is displayed 3 CAUTION False diagnosis The predicted values and the system interpretation are based on the patient demographic data Therefore wrong patient data can cause false res...

Page 83: ... the system interpretation are based on the patient demographic data Therefore wrong patient data can cause false results Enter patient data meticulously Double check that you have entered the patient data correctly Edit the entry and if applicable choose OK Note that these changes only apply to sessions going forward and not to previous sessions 6 Choose OK 7 Choose the home button 10 1 3 Deletin...

Page 84: ...d ch 84 144 92 10 1 4 Exporting data from EasyOne Air You can export data including reports to the SD memory card Required material An SD card 1 Unlock and open the battery compartment by turning the lock screw clockwise 2 Insert the SD memory card into the SD card slot 3 Close and lock the battery compartment by turning the lock screw counterclockwise 4 Choose ...

Page 85: ...rials choose or 4 To enlarge tap on the combined volume time curve and flow volume curve or on the parameter table 5 To reduce tap again on the combined volume time curve and flow volume curve or on the parameter table 6 If you want to print the report choose Print A progress bar is displayed which indicates the progress of the print out 7 To view another test do the following a Choose Back b From...

Page 86: ... patient data correctly Fill out those fields that are marked with an asterisk You cannot complete adding patient data without filling out these fields 4 In all other fields enter additional patient data if necessary 5 Choose OK 10 2 2 Editing patient data with EasyOne Connect 1 Choose Patients 2 Select a patient 3 Choose Edit 4 CAUTION False diagnosis The predicted values and the system interpret...

Page 87: ... the second release the mouse button If the dates of birth of the two data records match a confirmation window is displayed If the dates of birth of the two data records do not match a warning is displayed In this case you cannot merge these two data records 4 To finish confirm the message 10 2 4 Deleting patient data from the database of EasyOne Connect 1 Choose Patients 2 Select a patient 3 Choo...

Page 88: ...ts from EasyOne Air to EasyOne Connect then change patient data or add trials and copy data from EasyOne Air to EasyOne Connect again Instead first complete tests with EasyOne Air before you copy patient data and results to EasyOne Connect Make changes to existing patient data on EasyOne Air only Use EasyOne Connect only to create new patient records without results yet for sending to EasyOne Air ...

Page 89: ...atient record that you just have created 7 Choose EasyOne The selected patient record is send to EasyOne Air EasyOne Connect displays a message whether the sending has been successful You can remove EasyOne Air from the cradle or you can repeat steps 2 to 7 to create and send additional patient records Viewing and printing reports with EasyOne Connect 89 Connectivity and data exchange 44 10 2 6 Vi...

Page 90: ... you can mark trials that the system judged acceptable as unacceptable and vice versa Also you can change the trial ranking rank 1 2 3 and so forth To assess tests retrospectively 1 From any result screen in the parameter table choose the Trial Rank field for the particular trial An overlay window is displayed 2 To mark the selected trial as acceptable or unacceptable select or deselect the Accept...

Page 91: ... from EasyOne Connect Utilities Export Data This export is the most comprehensive export function in EasyOne Connect You can select which data to include in the export Each check box produces one file with the corresponding data To access data on an SQL server based database the SQL server must accept the Microsoft Active Directory user account that the current Windows user is logged in with 10 2 ...

Page 92: ...t to EasyWare Utilities Export EasyWare EasyWare is the PC software for EasyOne World the predecessor model of EasyOne Air EasyWare uses a different database format This export is compatible with the database format of EasyWare To access data on an SQL server based database the SQL server must accept the Microsoft Active Directory user account that the current Windows user is logged in with EasyWa...

Page 93: ...Default setting Speaker volume To set the speaker volume 0 100 50 Key click To enable sound for audible click feedback Selected deselected Selected Beep during maneuver To enable a beeping signal during breathing maneuvers as feedback about air flow Selected deselected Selected User Logon required To enable password protection Selected deselected Selected System Time To set the time Numeric entry ...

Page 94: ...plication Notes for further information 3 List of bibliographic references 132 Best trial best value selection If you choose the Best Trial option the complete best trial is selected for assessing the quality of the test and for assessing the interpretation The trial with the largest sum of FVC and FEV1 is selected as suggested by ATS and ERS If you choose the Best Value option the best single rel...

Page 95: ...pretation algorithm The diagram above shows how the interpretation for NLHEP is determined according to Ferguson 2000 NLHEP 4 NLHEP interpretation Caution interpret with care No Yes Yes FEV1 9 1 Yes FEV1 1 FEV1 SUHGLFWHG Yes Yes FEV1 SUHGLFWHG No No No No Normal spirometry No 9 1 RZ YLWDO FDSDFLW ɠ SRVVLEO GXH WR UHVWULFWLRQ RI OXQJ YROXPHV Yes Normal spirometry Q DGGLWLRQ ORZ YLWDO FDSDFLW ɠ SRVV...

Page 96: ...tus is not part of the GOLD Hardie standard of 2008 only of 2003 GOLD Hardie 2003 only GOLD Hardie Interpretation 2003 2008 START No interpretation No Yes FEV1 FVC limit age related age 70 years 70 HDUV DJH HDUV DJH HDUV Maneuver quality OK Obstruction Normal spirometry Very severe obstruction END FVC LLN and FEV1 LLN No Yes Yes Yes Yes No No No No Yes Possible restriction Restriction FEV1 FVC FEV...

Page 97: ...CE interpretation is mainly used in the UK NICE interpretation Yes Yes Yes No No No Yes No Yes Yes Check maneuver quality FEV1 FVC 70 START FEV1 80 of predicted FEV1 50 of predicted FEV1 30 of predicted Normal spirometry Moderate obstruction Mild obstruction Severe obstruction FEV1 and FVC 80 of predicted FEV1 80 of predicted FVC 80 of predicted Restrictive disorder Normal spirometry reduced FEV1 ...

Page 98: ...asurement continues until the end of test criteria are met or until you end the test manually With this setting all the intermediate flow values e g MEF25 FEF25 75 are reported If you choose the FEV6 option the measurement stops after six seconds With this setting none of the intermediate flow values e g MEF25 FEF25 75 are reported The FVC test determines the forced expiratory vital capacity The f...

Page 99: ... 8 provides guidance on the subject of ethnic correction This paper recommends using 88 of the Caucasian values when testing African patients and provides general guidance in selecting adjustments for other ethnic groups List of bibliographic references 132 11 1 1 3 Description of display settings of EasyOne Air On this screen you can choose settings that are related to the displayed software and ...

Page 100: ...rinter or a virtual PDF printer saves a PDF file PDF printer External printer External printer Printer page format To select the page format in imperial or metric dimensions US A4 A4 Number of pages To select between a full size or compact report format one page compact report two pages full size report two pages Data To set whether one or three trials are included on the printout corresponding to...

Page 101: ...ry card from the manufacturer In this menu you can update the firmware of EasyOne Air CAUTION FAILED UPDATE An update may fail unnoticed After performing an update restart EasyOne Air and EasyOne Connect and per form a calibration check Calibration check 118 Checking for correct operation of EasyOne Air 122 1 Unlock and open the battery compartment by turning the lock screw clockwise 2 Insert the ...

Page 102: ... is displayed whether the update was successful and EasyOne Air restarts 6 Remove the SD memory card 11 1 3 Performing a backup of EasyOne Air Required material An SD memory card with at least 2 GB of free space To archive a copy of the complete database including patient data and results and of the configuration settings perform backups regularly You can also use the backup to set up another Easy...

Page 103: ... a password 5 Do one of the following a To encrypt the backup with a password choose Set password and enter the password in the following window b To proceed without setting a password choose No password The SD memory card is checked for sufficient free space The complete database and all configuration settings are backed up to the SD memory card After successful completion of the backup a message...

Page 104: ...nges like deleting patient data users are not prompted for their passwords again Instead logs include the respective user Therefore sensitive changes can be traced back to individual users User groups There are two user groups Administrator and Technician Administrator users have full access and privileges to all menus and functions of EasyOne Connect Technician users have restricted access and pr...

Page 105: ...or their passwords again Instead logs include the respective user Therefore sensitive changes can be traced back to individual users User groups There are two user groups Administrator and Technician Administrator users have full access and privileges to all menus and functions of EasyOne Connect Technician users have restricted access and privileges At least one user has to remain as an Administr...

Page 106: ...econd database file into the currently active database both databases are merged Entries that exist in both databases are not duplicated Backup button To save a copy of the currently active database file Load Configuration button To load a configuration file a configuration file can contain settings for example for predicted normal values report headers or user handling Be aware that loading a con...

Page 107: ...the following message 7 To save the changes choose OK 8 To discard the changes choose Cancel About user handling and the default password of EasyOne Connect 105 11 2 4 Description of test configurations of EasyOne Connect 11 2 4 1 Utilities Configuration Test General Best trial best value selection If you choose the Best Trial option the complete best trial is selected for assessing the quality of...

Page 108: ...of a decimal ratio for example 0 78 choose Show ratio parameter in By default both check boxes are deselected To set the maximum number of trials for forced and slow spirometry enter a value between 1 and 99 in the text field Max Number of Trials Forced Slow The default value is 99 The text fields DLCO and MBW do not apply to the EasyOne Connect PC software but to the firmware of EasyOne Pro LAB o...

Page 109: ...pretation algorithm The diagram above shows how the interpretation for NLHEP is determined according to Ferguson 2000 NLHEP 4 NLHEP interpretation Caution interpret with care No Yes Yes FEV1 9 1 Yes FEV1 1 FEV1 SUHGLFWHG Yes Yes FEV1 SUHGLFWHG No No No No Normal spirometry No 9 1 RZ YLWDO FDSDFLW ɠ SRVVLEO GXH WR UHVWULFWLRQ RI OXQJ YROXPHV Yes Normal spirometry Q DGGLWLRQ ORZ YLWDO FDSDFLW ɠ SRVV...

Page 110: ...tus is not part of the GOLD Hardie standard of 2008 only of 2003 GOLD Hardie 2003 only GOLD Hardie Interpretation 2003 2008 START No interpretation No Yes FEV1 FVC limit age related age 70 years 70 HDUV DJH HDUV DJH HDUV Maneuver quality OK Obstruction Normal spirometry Very severe obstruction END FVC LLN and FEV1 LLN No Yes Yes Yes Yes No No No No Yes Possible restriction Restriction FEV1 FVC FEV...

Page 111: ...ICE interpretation is mainly used in the UK NICE interpretation Yes Yes Yes No No No Yes No Yes Yes Check maneuver quality FEV1 FVC 70 START FEV1 80 of predicted FEV1 50 of predicted FEV1 30 of predicted Normal spirometry Moderate obstruction Mild obstruction Severe obstruction FEV1 and FVC 80 of predicted FEV1 80 of predicted FVC 80 of predicted Restrictive disorder Normal spirometry reduced FEV1...

Page 112: ...lues and Interpretative Strategies 8 provides guidance on the subject of ethnic correction This paper recommends using 88 of the Caucasian values when testing African patients and provides general guidance in selecting adjustments for other ethnic groups List of bibliographic references 132 11 2 4 3 Recalculating predicted values of previous test results EasyOne Connect can recalculate predicted v...

Page 113: ...he intermediate flow values e g MEF25 FEF25 75 are reported If you choose the FEV6 option the measurement stops after six seconds With this setting none of the intermediate flow values e g MEF25 FEF25 75 are reported The FVC test determines the forced expiratory vital capacity The forced expiratory vital capacity is the maximum volume that the patient can exhale during the FVC breathing maneuver a...

Page 114: ...agnostic parameters to include on the test result screens and on the printed reports choose Select FVC and Select FVL Type To make regular breathing mandatory before the breathing maneuver choose Tidal Breathing Required 11 2 4 6 Utilities Configuration Test MVV Parameter To select which diagnostic parameters to include on the test result screens and on the printed reports choose Select FVC and Se...

Page 115: ...y on PC sensor If the Easy on PC sensor cannot connect the serial COM port might be used by another device To switch to a free serial COM port you can manually select one from the drop down list or choose the Auto Detect button Easy on PC Operator s Manual EasyOne Air Utilities Configuration Device Selection From this tab select the device that you want to use for performing spirometry with EasyOn...

Page 116: ...runs EasyOne Connect If you want to rename the report layout you only need to rename the REPX file The name of the report layout file is printed on every report To load the report layout file 1 Choose Utilities Configuration Report 2 Choose Load 3 Navigate to the report layout file select the file and choose Open 4 Read and confirm the warning message about custom report layouts To select your cus...

Page 117: ... the check box you are prompted every two hours to enter the environment conditions when performing spirometry From the environment conditions the ATPS values Ambient Temperature Pressure Saturated which describe the conditions for the spirometer are calculated The ATPS values are converted to BTPS values Body Temperature Pressure Saturated which describe the body conditions of the patient If you ...

Page 118: ...One Air yourself A third party service must not at tempt to repair EasyOne Air either Do not open or remove the casing If a calibration check fails contact only your EasyOne dealer or the ndd Servicing Department for repairs Contact information 4 12 1 About calibration check with EasyOne Air There are three types of calibration checks single cal check multi flow cal check and linearity cal check S...

Page 119: ... of 1 L s The trial is accepted if the parameter FEF25 75 or FIF25 75 is between 0 75 L s and 1 25 L s 3 L in approximately 6 s flow rate of 0 5 L s The trial is accepted if the parameter FEF25 75 or FIF25 75 is between 0 40 L s and 0 75 L s To pass the complete calibration check there must be one acceptable trial for each flow level The printout shows at least three trials one for each flow level...

Page 120: ...pter About calibration check with EasyOne Air 118 1 To assure that the temperature inside the syringe and the room temperature are the same push and draw the piston five times A temperature difference may lead to a failed calibration check Do not warm the body of the calibration syringe with your hands 2 Push the piston of the calibration syringe all the way in 3 Unwrap the EasyOne Flow Tube 4 Ins...

Page 121: ...pull the piston briefly again If the maneuver was not acceptable you need to repeat steps 9 to 11 If you have chosen Single flow before and the maneuver was acceptable the calibration check is completed If you have chosen Multi flow or Linearity before and the maneuver was acceptable proceed with step 12 12 If you have chosen Multi flow or Linearity before and the previous maneuver was acceptable ...

Page 122: ... yourself or on another known subject 3 Check the results of steps 1 and 2 for plausibility a If the results of steps 1 and 2 are plausible EasyOne Air is operating correctly b If the results of steps 1 and 2 are not plausible troubleshoot c If you are not able to remedy the defect contact your EasyOne dealer or the ndd Servicing Department Calibration check 118 Performing spirometry 51 List of tr...

Page 123: ...e connection Check the connections The specified syringe volume does not correspond to the actual syringe volume Choose the correct syringe volume under Configuration The curve is missing on the printout The ink cartridge of your printer is empty Replace the cartridge In the configuration of your EasyOne Air a black and white printer is selected but you actually use a color printer Go to Configura...

Page 124: ...ivate EasyOne Air you must setup EasyOne Air like you did for the first time setup List of specifications for EasyOne Air 125 About charging the battery of EasyOne Air 122 Setting up the EasyOne Air spirometer 24 Checking for correct operation of EasyOne Air 122 Contact information 4 13 5 Exporting logging information EasyOne Connect can export logging information The ndd Servicing Department or y...

Page 125: ...easurement principle Ultrasonic transit time measurement Display 320 x 240 LCD display Input method Touchscreen Test storage capacity Up to 10 000 tests Languages English French German Spanish Data Management EasyOne Connect PC software Printing option Direct to printer or with EasyOne Connect PC software Export EMR HL7 XML GDT with EasyOne Connect PC software Hardware interface USB Bluetooth Age ...

Page 126: ...02 11a b g j 802 11n 802 11d e i w 802 1X 802 11k r v 802 11h Modulation Bluetooth GFSK DQPSK 8DPSK WiFi OFDM with BPSK QPSK 16 QAM 64 QAM 802 11b with CCK and DSSS QoS WMM and WMM Power Save Support Frequency band Bluetooth 2 402 GHz to 2 480 GHz WiFi 2412 MHz 2484 MHz and 4910 MHz 5825 MHz Transmit power Bluetooth 15 dBm class 1 WiFi 18dBm Receive sensitivity Bluetooth 94dBm WiFi 97dBm Contains ...

Page 127: ...lity Requirements and tests IEC 62304 Medical device software Software life cycle processes IEC 62366 Medical devices Application of usability engineering to medical devices ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes ISO 14971 Medical devices Application of risk management to medical devices ISO 26782 Anesthetic and respiratory equipment Spirometers i...

Page 128: ... or power supply Store the battery in a cool dry and well ventilated area Dispose of the battery in accordance with local regulations Regulations vary for different countries RISK OF FIRE AND BURNS Do not open crush heat above 50 C 122 F or incinerate Follow the instructions in this Operator s Manual The following table contains additional information about the battery of EasyOne Air that might be...

Page 129: ...eric pressure 500 hPa to 1060 hPa Battery removed battery Standard operating conditions Temperature 0 C to 40 C 32 F to 104 F Relative humidity 5 to 90 Atmospheric pressure 700 hPa to 1060 hPa The following optimized conditions prolong the life expectancy of the battery Optimized environmental conditions Temperature 23 5 C 73 4 9 F Humidity 45 to 75 relative humidity Atmospheric Pressure 860 hPa t...

Page 130: ...nsult instructions for use Caution consult accompanying documents In the European Union the product you have purchased should not be disposed of as unsorted municipal waste Please make use of your local WEEE collection facilities to dispose of this product and otherwise observe all applicable requirements The battery was certified for the US market by SGS CSTC Standards Technical Services Co Ltd S...

Page 131: ...wide 5050 200 EasyOne Flow Tube box of 500 pcs EasyOne Flow Tube individually wrapped box of 500 pieces Worldwide 5050 500 ndd calibration syringe 3 L with EasyOne Flow Tube cal check adapter ndd calibration syringe 3 liters for optional calibration check procedures includes an EasyOne Flow Tube cal check adapter Worldwide 2030 2 EasyOne Flow Tube cal check adapter Individual cal check adapter for...

Page 132: ...hiladelphia 1987 7 Hyatt Scanlon Nakamura Interpretation of Pulmonary Function Tests A Practical Guide Lippincott Raven Philadelphia 1997 8 American Thoracic Society Lung Function Testing Selection of Reference Values and Interpretative Strategies American Review of Respiratory Disease Vol 144 1991 pp 1202 1218 9 Morris Temple Short Report Spirometric Lung Age Estimation for Motivating Smoking Ces...

Page 133: ...uropean Respiratory Society Statement Pulmonary Function Testing in Preschool Children American Journal of Respiratory and Critical Care Medicine Vol 175 2007 pp 1304 1345 15 Occupational Safety and Health Administration Spirometry Testing in Occupational Health Programs Best Practices for Healthcare Professionals OSHA 3637 03 2013 Application Note Reference Predicted Normal Values Application Not...

Page 134: ...see provocation tests Bronchodilation 54 BTPS Body Temperature Pressure Saturated 117 C Calibration choosing syringe volume 114 Multiflow calibration check 114 result messages 73 selecting calibration check type 114 selecting curve type for report 114 Single Flow calibration check 114 Calibration check 118 Calibration check menu on EasyOne Air 120 Charging the battery 122 Cleaning avoiding contami...

Page 135: ... information 124 exporting XML 91 installing and updating 25 overview of features 33 printing reports 89 processing orders 48 sending test results to EMR system 50 system requirements 132 trend view 90 working with patient data 82 EasyOne Flow Tube overview 27 EasyOne products 44 EMR system 44 custom plug in 48 49 50 direct start workflow 49 GDT plug in 47 49 50 113 HL7 plug in 47 48 49 50 initiat...

Page 136: ... configuration menu in EasyOne Connect 104 history menu in EasyOne Connect 34 history menu on EasyOne Air 85 home screen on EasyOne Air 29 main menu in EasyOne Connect 34 more menu on EasyOne Air 29 orders menu in EasyOne Connect 48 orders menu on EasyOne Air 29 patients menu in EasyOne Connect 34 patients menu on EasyOne Air 29 reports menu on EasyOne Air 29 settings menu on EasyOne Air 93 summar...

Page 137: ...ta 82 Performing spirometry 51 Plug ins for EMR systems custom plug in 48 49 50 GDT plug in 47 49 50 113 HL7 plug in 47 48 49 50 XML file exchange plug in 48 49 50 Post about posts and bronchodilation 54 definition 35 Predicted normal values 39 Preparing patient for testing 52 Printer compatible printers 19 configuration 116 Printing lung age on reports 114 reports in EasyOne Connect 89 reports on...

Page 138: ...orming EasyOne Connect and EasyOne Air 63 selecting existing patient 55 settings 94 108 SSA tests quality grades 74 Status bar on EasyOne Air 32 Storage configuration 106 Summary screen on EasyOne Air 56 SVC tests 36 performing breathing maneuver 79 quality grades 74 quality messages 73 see also tests Syringe volume setting 114 System accessories order numbers 131 checking for correct operation 12...

Page 139: ...test SVC tests Theft of EasyOne Pro LAB 42 Tidal Breathing Required option 114 Tools menu on EasyOne Air 29 Touchscreen using 28 Trend view 90 Trials Best Trial option 94 107 Best Value option 94 107 comparing trials setting 108 definition 35 marking as acceptable unacceptable 90 quality grades 53 73 quality messages 73 selecting calibration check type 114 Troubleshooting checking for correct oper...

Page 140: ...eration in accordance with the information given in tables below A 1 2 Safety information See Safety information regarding electromagnetic compatibility 14 A 1 3 Compliant cables and accessories WARNING INCREASED EMISSIONS OR DECREASED IMMUNITY The use of accessories transducers and cables other than those specified may result in increased emission or decreased immunity performance of the equipmen...

Page 141: ...agnetic environment guidance RF emissions CISPR 11 Group 1 EasyOne Air uses RF energy for its internal function Additionally the EUT contains a Radio Bluetooth BLE and WLAN module which complies with the national regulations Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment However a separation distance of 30 cm shall be maintained ...

Page 142: ...kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line 2 kV line to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on...

Page 143: ...cinity of equipment marked with the following icon Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios ama...

Page 144: ... m 0 1 W 0 38 m 0 11 m 0 22 m 1 W 1 2 m 0 35 m 0 70 m 10 W 3 8 m 1 1 m 2 2 m 100 W 12 m 3 5 m 7 0 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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...

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