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Summary of Contents for NDD EasyOne
- Page 1 EasyGuide Operator s Manual EasyOne Spirometer ndd Medical Technologies ndd Medizintechnik AG Two Dundee Park Technoparkstr. 1 Andover, MA 01810 CH-8005 Zürich www.nddmed.com www.ndd.ch 2070-3_EN_V72.docx 01 Feb. 2011...
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Page 2: Table Of Contents
Electromagnetic Compatibility (EMC) ....................31 Specifications and information contained in this manual are furnished for informational use only and are subject to change at any time with- out notice. Copyright© 2011 by ndd Medizintechnik AG, Switzerland. All rights reserved. EasyOne and spirette are protected by the fol- lowing patents: EP 0597060, EP 0653919, US 5419326, US 5503151, US 5645071, US5647370. -
Page 3: Introduction
FV and VT curves The default setting of the EasyOne Spirometer is the Diagnostic Mode. To switch the EasyOne into the Frontline Mode, see Chapter 8 under General Settings . The EasyOne -line Spirometer does not contain the EasyOne cradle. -
Page 4: Warning Information
Caution: All users must be trained and adequately instructed in the operation of the device. Caution: Calibration and servicing may be carried out only by ndd staff. Do not open the in- strument. Caution: Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness. -
Page 5: Intended Use
Quickstart CD. The following picture shows the spirometer in combination with a printer. The following picture shows the parts supplied with the EasyOne -line. It additionally includes the EasyWare PC software and the screen connector instead of the USB cradle. - Page 6 The spirette is easily removed by pushing it up from the bottom. Please note: Use only authentic ndd disposables to assure accuracy, long-life, and full war- ranty coverage.
- Page 7 EasyGuide Page 6 If you wish to export data to a PC, or print reports via the PC, connect the EasyOne base unit to a PC using the USB cable. EasyWare or EasyWare Lite must be installed on the PC.
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Page 8: Setting Language, Date, Time, Altitude (Above Sea Level) And Printer Type
EasyGuide Page 7 The following picture shows how the EasyOne Screen Connector is used: Caution: Connect only printers and computers that comply with IEC 60950-1 Standards. Setting Language, Date, Time, Altitude (above sea level) and Printer Type Press the (ON/OFF) key for at least 2 seconds in order to switch on the instrument. The instrument switches off automatically if no key is pressed for 15 minutes. - Page 9 EasyGuide Page 8 the upper-case letters, then to the number and then to the lower-case letters, umlauts and special characters can be found on key (1). Please note: The escape key (Esc-0) is particularly helpful and important in unit navigation. The escape function requires the key to be pressed and held momentarily.
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Page 10: Performing Spirometry
EasyGuide Page 9 5 Performing Spirometry Preparing the Patient Prepare for testing by having the patient loosen tight clothing, remove dentures, and relax. The patient may sit or stand. If standing you may want to perform testing in an area free of sharp table or counter edges, or have a chair handy as there is a slight possibility that the patient could faint during the stre- nuous spirometry maneuver. -
Page 11: Checking The Test Quality
Repeat this until you reach the main menu. You can conduct the following tests with EasyOne : FVC (expiratory), FVL (inspiratory and expiratory), Tidal FVL, pre/post tests, slow spirometry and MVV. Please also see Chapter 9. There are also protocols that ensure that testing complies with the guidelines for NIOSH/OSHA/Cotton Dust and Social Security Administration Disability evaluations. -
Page 12: Printing A Report
Printing a Report You will require a base unit and a compatible printer in order to print a report directly from EasyOne . With base unit or Screen Connector reports can also be printed via a PC using the software EasyWare. -
Page 13: Editing Patient Data
EasyGuide Page 12 It is possible to enter patient data after having performed a quick test. Proceed as described in Chapter 5.8. Once patient data is entered predicted normals will be displayed and printed. Editing Patient Data You have the option of editing or adding patient data after a test has been performed. To do this, choose Edit Database in the main menu and press ENTER. -
Page 14: Specifications
EasyGuide Page 13 6 Specifications EasyOne Model 2001 Spirometer Size: 83 x 158 x 43 millimeters (3.3 x 6.2 x 1.7 inches) Weight: 255 grams (9 ounces) Measuring accuracy Volume: ±2% or 0.050 l Flow: ±2% or 0.020 l/s, (except PEF) PEF: ±5% or 0.200 l/s... -
Page 15: Easyone Model 2010 Cradle (Optional)
Accessories 2050-1 Case of 50 spirette 2050-5 Case of 200 spirette 2050-6 Case of 75 spirette no wrapping 2040-2 EasyWare USB 2030-2 Calibration syringe Please note: Use only authentic ndd disposables to assure accuracy, long-life, and full war- ranty coverage. -
Page 16: Definition Of Parameters
EasyGuide Page 15 7 Definition of Parameters Forced Vital Capacity (expiratory) FIVC Forced Vital Capacity (inspiratory) FEV1 Forced Expiratory Volume (1 sec). FEV6 Forced Expiratory Volume (6 sec). FEV1/FVC Ratio of FEV1 to FVC FEV1/VC Ratio of FEV1 to VC taken from SVC test FEV1/FEV6 Ratio of FEV1 to FEV6 MEF 25... -
Page 17: System Configuration
If you wish to change the instrument setting, please choose the Configuration option in the main menu. You will now be in the Configuration menu. The tables below provide an overview of the setting options offered to you by EasyOne . Choose the option you require. Test Settings Test settings are not available in NLHEP mode (all options are fixed in this mode). -
Page 18: General Settings
Curve storage (*) all curves, best best curve When set to ALL EasyOne can save up to 8 curve curves of a test. This is necessary if you want to print the 3 best curves or if you want to export the curve data of each trial. -
Page 19: Printer Settings
EasyGuide Page 18 Printer Settings Default Relates to Option Description setting Printer type HP b/w, HP color, Ca- HP b&w Choose the right option to match your available non b/w, Canon color, printer. See Chapter 15 if you have problems. Epson b/w, Epson Via PC should be entered if you want to print using color, Canon 300bw,... -
Page 20: Test Types
In this test mode the patient can do tidal breathing before the full FVL maneuver, as described in Chap- ter 9.2. When the maneuver is finished press enter to manually stop the trial. This test mode is mainly used with the EasyOne line setup. -
Page 21: Mvv
EasyGuide Page 20 The instrument now prompts you to avoid flow in the spirette while it is setting the baseline. It is advisable to block off the spirette at one end to ensure the baseline is set precisely. An aud- ible signal sounds when the zero point is set. -
Page 22: Adding A Trial
EasyGuide Page 21 the result screen and on the test protocol. Post-Tests can only be added to previous tests on the same day. To add the Post -test immediately after the FVC or the FVL test select the field POST on the result screen. -
Page 23: Quality Messages And Quality Grades
EasyGuide Page 22 10 Quality Messages and Quality Grades 10.1 Quality Messages The quality messages assist you in conducting the measurement. After each test, they provide informa- tion as to whether the test is acceptable or what to do to improve the result. Message Criterion Recommended action... -
Page 24: Quality Grades
In the system configuration the best value selection can be set to Best Trial or Best Value . The two settings are defined as follows: Best trial: EasyOne selects the trial with the largest sum of FVC and FEV1 (this is suggested by ATS and ERS). -
Page 25: Interpretation
EasyGuide Page 24 11 Interpretation Automatic interpretation can be activated (Setting: NLHEP or GOLD/HARDIE) or deactivated under Con- figuration (see Chapter 8) 11.1 NLHEP Interpretation The diagram below describes how the interpretation is determined (see reference [4]). START Caution: Interpret with care test session good normal spirometry... -
Page 26: Gold/Hardie Interpretation
EasyGuide Page 25 11.2 GOLD/Hardie Interpretation The diagram below describes how the interpretation is determined (see reference [11] , [12]) START Maneuve r Quality Interpretation FEV1/FVC limit age related: age < 70 years: 70% 70 <= age < 80: 65% age >... -
Page 27: Predicted Values
LLN of relational parameters, e.g. FEV1/FVC are set to 90% of Predicted Value, LLN of all other parameters are set to 80% of Predicted Value. If the patient data lies outside of the range defined in the publication (Age, Height) EasyOne uses extrapolated values. -
Page 28: Ethnic Correction
Please consult your EasyOne dealer or call the ndd Servicing Dept., number +41 (44) 445 29 70 in the event of defects or malfunctions. Proceed as follows to check correct operation of your instrument: 1. -
Page 29: Checking Calibration
To perform a calibration check, you need the optional ndd calibration adapter and an optional calibra- tion syringe (order number 2030-2), in addition to the spirometer and a spirette . Ensure that the cor- rect syringe volume is entered in the instrument s configuration setting (see also Chapter 8). -
Page 30: Troubleshooting Tips
Chapter 4.1. tion check You have not used an ndd adapter Use the ndd calibration adapter. There are leaks in the syringe connec- Check the connections. tion The specified syringe volume does not... -
Page 31: Bibliography
Chapter 4.1. message device selftest error #14 or #15 appears in the screen The internal battery of the EasyOne Switch the EasyOne off and on When switching on the instru- may be defect again. If the same message appears... -
Page 32: Electromagnetic Compatibility (Emc)
Page 31 17 Electromagnetic Compatibility (EMC) Changes or modification to the EasyOne system not expressly approved by ndd could cause EMC is- sues with this or other equipment. The EasyOne system is designed and tested to comply with appli- cable regulation regarding EMC and needs to be installed and put into service according to the EMC information stated as follows. - Page 33 The customer or the user of the EasyOne can help prevent electromagnetic interference by maintaining a minimum distance between portable and mo-bile RF communications equipment (transmitters) and the EasyOne as recommended below, according to the maximum output power of the communications equipment.
- Page 34 EasyGuide Page 33...
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