User Manual Whistler LFMi
Contents
1. UMA accepted vatia 41 7197 1 1215 46 7890 Ae accepted valid a vatia 46 7742 Mean 0 0000 _ o 0000 48 4984 Device is connected 0050 002 2000 0006 0x30 04810 reading 1 W Consult the Rint result screen Click on the Export button to export the results of the complete measurement Print report button to print the measuring results of the current tab e Patient button to return to the patient screen NO 0050 002 0020 06 41 AS Lung function measurements WHISTLER Note i The pull down menu in the Rint result screen enables the selection of the individ ual measurements Tip Pressing on the plot zooms in on the selected plot clicking again restores the view Dragging over the plot zooms in on the selected area dragging again restores the view right clicking on the trial in the table Rejected trials will be excluded from the cal culation of the mean and the standard deviation Note It is possible to add comments to the medical report by pressing the green pencil and saving by using the blue disk Note i During inspection of the data it is possible to manually reject or accept trials by 42 0050 002 0020 06 AN WHISTLER Cleaning instructions Cleaning instructions CAUTION Do not sterilize the Whistler LFMi The instrument is not suitable for sterilization Note il Read and ob2. 0050 002 0020 06 aS WHISTLER 6 5 9 Dry the sensor 1 Leave the sensor to dry during at least 10 minutes Make sure that the connector points downward to allow the fluid to leak out of the suction cups 6 5 10 Install the occlusion valve 1 Make sure that the occlusion valve A is perfectly clean and dry 2 Gently squeeze the occlusion valve between your thumb and forefinger Tip Attach one end of the occlusion valve on one side of the sensor end and push the occlusion valve as far as possible on the sensor end 3 Use your thumb and your forefinger to pull the other end of the occlusion valve over the other side of the sensor end Cleaning instructions Tip i Do not try to push the occlusion valve simultaneously over both sides of the sensor end Do not put your finger inside the occlusion valve 0050 002 0020 06 49 Cleaning instructions 4 Slide the occlusion valve A over the sensor end B Make sure that the positioning lugs C fit in the counterparts in the sensor end 5 Check the shape of the occlusion valve The occlusion valve must be perfectly symmetric If this is not the case adjust the shape of the occlusion valve Note Asymmetry of the occlusion valve is not allowed 6 Compress both ends of the occlusion valve with your thumb and your forefinger The occlusion valve will open a little
3. Position Definition Description number A Occlusion mechanism Occlusion part that shuts the occlusion valve B Connector Enables the electrical connection between the sensor and the cradle See the note below C Pressure contact points Pressure contact points for the pressure suction cups in the sensor D Hinges Serve to connect and position the cradle and the sen sor E Type plate Type plate see section 1 9 1 Note Do not damage the contacts Keep the contacts dry 0050 002 0020 06 13 AS General description WHISTLER 3 2 4 SOT Rint sensor Position Definition Description number A Occlusion valve Silicon rubber valve B Sensor locking mechanism Serves to lock the sensor in the cradle Cc Type plate Type plate see section 1 9 2 D Connector Enables the electrical connection between the sensor and the cradle See the note below E Suction cups Ensure an airtight connection with the contact points on the cradle Note a Do not damage the contacts Keep the contacts dry 14 0050 002 0020 06 ON WHISTLER General description 3 2 5 Accessories required for the measurements Disposable face mask Disposable nose clip Disposable bacterial filter Filter adapter vou gt 0050 002 0020 06 15 Preparations for use 4 Preparations for use Note il Read and observe the safety instructions in chapter 2 4 1 Exchange the sensor CAUTIO
4. Zeroing of the sensor has failed Place the sensor on the table and press Reset Zero Flow Do the following actions 1 Place the sensor on the table 2 Press Reset Zero Flow Damaged suction cups Obstructed suction cups Obstructed pressure channels Damaged pressure mani fold Obstructed pressure manifold Do the following actions 1 Check the suction cups for possible damage or obstruction 2 Check the pressure chan nels for possible obstruc tion 3 If this fails return sensor to manufacturer for repair see section 1 6 Do the following actions 1 Check the manifold for possible damage or obstruction see section 6 3 2 If this fails return sensor to manufacturer for repair see section 1 6 Internal electronics defect Return sensor to manufac turer for repair see section 1 6 58 0050 002 0020 06 aS WHISTLER Troubleshooting Problem Possible cause Solution Instrument is connected but no occlusions are being gen erated SOT Rint sensor only Instrument is connected but a manual occlusion fails SOT Rint sensor only Irregular tidal breathing Try to calm down or distract the patient so tidal breathing stabilizes Volume drift during tidal breathing e Leakage around the face mask filter mouthpiece Do the following actions 1 Verify the position of the facemask filter mouth piece an
5. Only use a Whistler LFMi that has been cleaned according to the instructions in chapter 6 Only use the Whistler LFMi on patients with a normal anatomy 2 5 When you use the Whistler LFMi Stay alert and watch what you are doing Use common sense Do not operate the Whistler LFMi when you are tired or have been taking alcohol medicine or drugs Do not smoke For each patient always use a new disposable face mask or a new disposable bacterial filter For each measurement use the dedicated and recommended types of face masks and bacterial filters Use the appropriate sensor for the measurement When you use the SOT Rint sensor for a specific measurement instruct your patient to breathe normally A powerful intake of breath can cause the occlusion valve to close During the measurements always check that the patient can breathe freely If not remove the Whistler LFMi from the patient During the measurements disconnect the USB cable from the Whistler LFMi 2 6 When you have used the Whistler LFMi Thoroughly clean the Whistler LFMi in compliance with the procedures that apply in your working environment and according to the guidelines in chapter 6 Do not sterilize the instrument Store the Whistler LFMi in its case in a clean and dry environment out of reach of unauthorised persons See section 10 3 2 for the recommended storage conditions 0050 002 0020 06 a gt WHISTLER General description 3 General description 3 1
6. Charging Battery is charging The slider in the background gives an indication of the battery voltage Error Event History This area turns RED in case of an error and the error message is displayed for 10 seconds Clicking on this area brings up a list with the Errors and Events that have occurred 22 0050 002 0020 06 aS WHISTLER Lung function measurements Status bar item from left to right Information Connection information Displays the actual connected device User information The logged on user and the corresponding access rights Ambient conditions This area turns RED if the ambient conditions have not been recently updated Clicking on this area brings up the ambient conditions pop up see sec tion 5 1 4 This area turns GREEN after updating the ambient conditions 0050 002 0020 06 23 aS Lung function measurements WHISTLER 5 1 3 Patient screen The system shows the Patient screen after logon see section 5 1 1 or by a click on the Patient button in the tool bar see section 5 1 2 irometry Software Patient John Doe 01 01 2012 amp SOT RINT ua ant C4 RK EIN EIN EA Start Visit SOT Device is connected 0050 002 2000 0006 0x30048 0 reading 1 W User admin 1 Inthe Patient screen either select an existing patient or make a new patient file 2 To make a new patient entry a Clic
7. y YES Rinse the sensor with clean water 4 Is there pollution visible inside the sensor NO y Disinfect the sensor with ethanol y Remove the occlusion valve y Dry the sensor y Install the occlusion valve y Check that there are no ethanol vapours left behind inside the sensor y End of cleaning procedure YES gt Prepare the soap solution y Clean the sensor with a brush y Clean the sensor with the soap solution 1 0050 002 0020 06 Complete the flowchart See the following sections for a detailed description of the required actions 45 Cleaning instructions 6 5 2 Remove the end cap of the sensor 1 Pull the end cap A off the sensor 2 Rinse the end cap with clean water 6 5 3 Rinse the sensor with clean water 1 Rinse the empty space inside the sensor with clean water A 6 5 4 Prepare the soap solution 1 Prepare a soap solution with lukewarm water and Neodisher LM2 Note Mixing ratio 1 of lukewarm water 10 ml of Neodisher LM2 The soap solution is perishable Use the soap solution within the next 24 hours 46 WHISTLER 0050 002 0020 06 aS WHISTLER 6 5 5 Clean the sensor with a brush 1 Clean the empty space inside the sensor with a medical cleaning brush se
8. 66 0050 002 0020 06 aS WHISTLER Technical specifications Item Specification Occlusion settings SOT occlusion time 400 to 1500 ms configurable Rint occlusion time 100 ms Valve type low noise silicon rubber valve Noise occlusion lt 65 dbA peak During measurement Baseline instability to the environment N A Volume drift correction no volume drift connection is performed a ERS recommendation is 200 Hz 10 6 Accessories Tip i Please see the website www medispirit eu for the actual list and the procedures on obtaining accessories Item Specification Medical USB battery charger TRUMPower TMW7 5 IPW with exchangeable plug TRM IPE EU Plug TRM IPU US China Plug TRM IPA Australian Plug TRM IPB Brit ish Plug Input 90 264 VAC 0 2A max 47 63 Hz output 4 5 5 9 V 1 33 1 01 A USB cable USB 2 0 cable Type A m mini B m 1 8 m Bluetooth dongle SWEEX BT204 Bluetooth Micro Adapter Class Il Bluetooth 2 1 EDR 2 4 GHz ISM band range up to 10 m Medical cleaning brush A standard medical cleaning brush with a grip a diameter lt 1 5 mm and with a span of gt 15 cm Cleaning syringe A standard medical syringe with content of 20 ml Clamp A clamp to keep the occlusion valve closed dur ing cleaning 0050 002 0020 06 67 AS Technical specifications WHISTLER 10 7 Spare pa
9. Characteristics The Whistler LFMi is a handheld lung function measurement instrument that is used for different types of lung function measurements for patients of all ages Note i The Whistler LFMi measures calculates and presents lung function parameters but does not give any diagnosis The interpretation of the results of the measure ments and the deduction of conclusions from these results always remains the responsibility of the medical specialist 0050 002 0020 06 9 ON General description WHISTLER 3 2 Main components A complete Whistler LFMi configuration consists of the components shown in the figure below A wW B ae j Da NE Whistler LFMi see section 3 2 1 and section 3 2 3 Exchangeable sensor see section 3 2 4 Accessories required for the measurements see section 3 2 5 Battery charger with USB cable Bluetooth dongle User manual CD Rom containing the User manual the Software installation manual Whistler LFMi and the software of the Whistler LFMi oaonmoou gt Note i Some battery chargers have an integrated USB cable 10 0050 002 0020 06 WHISTLER 3 2 1 Cradle and sensors General description Position Definition Description number A Cradle Contains the electronics the battery and the occlusion mechanism see section 3 2 3 B SOT Rint sensor Exchangeable sensor for both SOT and Rint meas urements see sectio
10. Requirements and tests Graphical symbols for use in labeling of medical devices ISO 14971 2012 Medical devices Application of risk manage ment to medical devices IEC 62304 2006 and AC 2008 Medical device software Software life cycle processes IEC 62366 2008 Medical devices Application of usability to medical devices EN 60601 1 4 1996 A1 2000 Medical electrical equipment Part 1 General requirements for safety 4 Collateral standard Programmable electrical medical systems IEC 60601 1 6 2010 Medical electrical equipment Part 1 6 General requirements for basic safety and essential per formance Collateral standard Usability IEC 60601 1 8 2007 C11 2010 64 Medical electrical equipment Part 1 6 General requirements for basic safety and essential per formance Collateral standard General require ments tests and guidance for alarm systems in medical electrical equipment and medical elec trical systems 0050 002 0020 06 WHISTLER Technical specifications 10 2 Dimensions and weight Item Specification Dimensions I x w x h Whistler LFMi with sensor without accessories lt 180 x 85 x 50 mm Weight Whistler LFMi with sensor with out accessories lt 0 5kg 10 3 Environmental conditions 10 3 1 Operational Item Specification Temperature range 17 to 35 C Relative humidity 30 to 95 Air
11. charged The battery status indicator will light continuously 4 Keep the ON OFF button pressed during 3 seconds to switch the Whistler LFMi OFF Note i The battery is incorporated into the cradle You do not have access to the battery compartment When the battery can no longer be recharged return the Whistler LFMi to the manufacturer or to your distributor 4 3 Place the Bluetooth dongle 1 Place the Bluetooth dongle A in the laptop Tip i See the Software installation manual Whistler LFMi for the initial installation of the dongle 18 0050 002 0020 06 a gt WHISTLER Lung function measurements Lung function measurements Prepare the Whistler LFMi application Tip See the Software installation manual Whistler LFMi for the initial installation of the software Note FM Read and observe the safety instructions in chapter 2 5 1 0050 002 0020 06 19 WHISTLER Lung function measurements 5 1 1 Logon 1 Start the Whistler application and wait for the logon screen SOT RINT SOT RINT 4 a r eT 57 X O There are tems ini Event History Device is disconnected NOT reading I User Not logged on None 23 0 C 32RA 102000 Note In the Logon screen the upper menu bar and the tool bar are not yet active See section 5 1 2 for a description of these bars 2 Enter the user name case sensitive Enter the password case sensitive 4 Click on the Logon button T
12. plot clicking again restores the view Dragging over the plot zooms in on the selected area dragging again restores the view right clicking on the trial in the table Rejected trials will be excluded from the cal culation of the mean and the standard deviation Each trial contains an occlusion and the measurement results are calculated on this trial Note It is possible to add comments to the medical report by pressing the green pencil and saving by using the blue disk Note i During inspection of the data it is possible to manually reject or accept trials by 34 0050 002 0020 06 a gt WHISTLER Lung function measurements 5 4 Rint measurement 5 4 1 Rint measurement principle The Rint measurement has been developed for children in the age of 12 months or older These children no longer have the Hering Breuer reflex The measurement is based on flow and pressure measurement during a short occlusion period It can be used for children and also for adults not capable of handling the instrument or understanding instructions given There are two possibilities to perform a Rint measurement by using a disposable bacterial filter see section 5 4 2 For this type of measurement a nose clip is required The nose clip is also a disposable by using a disposable face mask see section 5 4 3 Note i The use of a disposable bacterial filter with the nose clip is preferred If the patient does not accept the bacterial filter
13. the following actions 1 Inspect the event history to see which errors have occurred The red error indicator will only switch off after the instrument has been connected The green battery status indi cator starts blinking The battery voltage has become low Do the following actions 1 Continue with the meas urement 2 Charge the battery after finishing the measure ment Approximately 100 occlu sions of 500 ms are still possible after the battery status indicator has started blinking 0050 002 0020 06 61 Troubleshooting WHISTLER Problem Possible cause Solution During measurement the LED ring is off or lit only half Defect on LED ring Do the following actions 1 Ignore the defect The measurement with the patient can continue 2 Return to manufacturer for repair when appropri ate see section 1 6 Instrument generates 1 short beep and switches off The instrument has detected that it is not in use anymore and automatically switches off to save battery power Switch off the instrument when the instrument is not used anymore Instrument generates a sequence of 3 short beeps and switches off Internal buzzer does not gen erate a beep The instrument has detected that the battery is running too low and automatically switches off The internal buzzer broken Charge the battery Test the functionality of the internal buzzer by powerin
14. to manufacturer for repair see section 7 6 Hold the ON OFF button for 3 seconds or more see section 5 2 1 Firmware lockup Do the following actions 1 Disconnect all cables from the instrument 2 Press the reset button using a paperclip or simi lar to fully power off the instrument see section 3 2 1 Software crash Unsupported operation Restart the software and try again Battery runs low very quick Defect USB charger e Defect USB cable Do the following actions 1 Try another charger or try the USB port of the com puter 2 Try another USB cable Defect battery Defect on the internal charging circuit Return to manufacturer for repair see section 7 6 0050 002 0020 06 55 Troubleshooting WHISTLER Problem Possible cause Solution Sensor does not fit properly on the cradle Object present between sen sor and cradle Make sure no objects are present between the cradle and the sensor The sensor is not properly attached Verify if the sensor locking mechanism is locked at both sides Press the sensor firmly on the cradle to get a good lock Bluetooth communication fails Instrument not powered on Switch on the instrument The Bluetooth dongle not inserted in the computer Do the following actions 1 Close the application plug in the Bluetooth don gle or plug into a different USB port 2 Rest
15. 13 Version 06 0050 002 0020 06 WHISTLER Table of contents 1 General information Tet Intended users naeh un 1 1 2 Intended use of the Whistler LFMi 240ssnnssnssnnnensnnnnonnnnnonnsnnnennnnnnn 1 1 3 About this document 2 Here 1 1 4 Available technical documentation on the Whistler LFMi u 2 1 5 C nventiohs un seenanseen air 1 5 1 Pictogram resines ren 1 5 2 Typographical and authoring conventions 1 6 Service and suppott uuusnnssunsnnnnnnnnnnnnnnnnnnnannnnnnannnnnnnnnnnnnnnnnnannnnnnnnnnnnannnnnnn 1 7 Protection of the environment c ccccecceeeeeeeeeeeeeeeeeeeeeteneeeeseaeeeseeeeseieeeeees 4 1 8 Abbreviations wi 4 1 9 Identification of the Whistler LFMi we 4 1 9 1 Type plate on the cradle Bar 1 9 2 Type plate on the SOT Rint sensor uss22400nsnnnnnnnnnennnnnnnnnnnnn 5 Safety instructions 21 General ehlasensaieseie 6 2 2 This document 200042400unsnnnnnannnnnnnnnnnonnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnannnnnnnnnnnnnnnnnnn 6 2 3 Decals and instructions on the Whistler LFMi cccceeeeeeeeeeeeeeeeteeeeeeee 6 2 3 1 Decals and instructions on the cradle u nennen 7 2 3 2 Decals and instructions on the Sensors c ccceeeeceeeeeeeeeteteeeeteeees 7 2 4 Before you use the Whistler LFMi cccceceeceeee
16. 2 0020 xx basic troubleshooting Software installation manual Whistler Installation and configura 0050 002 0021 xxP LFMi tion of the Whistler LFMi software a Xx version number b xx version number These documents have been prepared with great care and in compliance with the relevant regulations The contents is based on our experience and latest knowledge The information in these documents is therefore valid and correct at the moment of release the release date is on the front cover ofthe document However changes and improvements may be made to these documents at any time and without prior notice The source language of these documents is English As a translation may be imprecise or inaccurate the original English text will be legally binding The English text shall prevail in the case of any difference between the source text and the translation Note il As we continuously improve and develop our products it is not always possible to provide a truthful picture of every single detail of the Whistler LFMi The illustra tions in these documents therefore always show a typical and standard Whistler LFMi Optional features or extra accessories will be clearly marked both in the text and if required in the illustrations 1 5 Conventions The following conventions apply for this document 1 5 1 Pictograms The following pictograms are used in this document 2 0050 002 0020 06 aS WHISTLER Gener
17. N Before you place or replace the sen sor 1 Press the sensor release buttons A to release the sensor 16 Switch the Whistler LFMi OFF Keep the ON OFF button pressed for 3 seconds Make sure that there is no USB cable in the USB port Make sure that there are no objects between the sensor and the cradle Make sure that the new sensor is clean and dry inside the tube Remove a possible smell of etha nol by blowing through the sensor using a disposible bacterial filter WHISTLER 0050 002 0020 06 WHISTLER 2 Lift the cradle A off the sensor B 3 Place the cradle A on the sensor B Note Make sure that the hinges C fit cor rectly 4 Press the cradle A and the sensor B together until the sensor clicks in position Note Make sure that both sensor locks click in position 0050 002 0020 06 Preparations for use 17 AS Preparations for use WHISTLER 4 2 Charge the battery 1 Charge the battery with the help of the USB cable A and the battery charger B During charging the battery status indicator flashes slowly 2 Check the battery status indicator If the battery status indicator remains continuously ON the battery condition is OK If the battery status indicator flashes the battery must be charged CAUTION Do not use the Whistler LFMi during B charging 3 Disconnect the USB cable when the battery is fully
18. User Manual Whistler LFMi WHISTLER Lung Function Measurement instrument 0050 002 0020 06 WHISTLER Copyright Copyright 2013 by MediSpirit BV All Rights Reserved No part of this document may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic or mechanical including photocopying and recording for any purpose without the express written permission of MediSpirit BV The software described in this document if applicable is furnished under the Software License Agreement The software may be used or copied only in accordance with the terms of the license Information in this document is subject to change without notice and does not represent a commitment on the part of MediSpirit BV In no event shall MediSpirit BV be liable for incidental or consequential damages arising from use of this document or the software if applicable and hardware described herein The original English text of this document will be legally binding and shall prevail in case of any variance between the English text and a translation MediSpirit BV De Pinckart 24 5670 AA Nuenen as The Netherlands http Awww medispirit eu MediSpirit info medispirit eu ii 0050 002 0020 06 aS WHISTLER Revision history Date Definition March 2012 Version 01 July 2012 Version 02 August 2012 Version 03 November 2012 Version 04 December 2012 Version 05 February 20
19. al information WARNING Identifies safety instructions that are intended to warn of possible physical danger Failure to comply with these safety instructions can result in fatalities or serious personal injuries The icon in front of the alert identifies the nature of the warning The exclamation mark denotes a general warning CAUTION Identifies safety instructions that are intended to warn of minor personal injuries Failure to comply with these safety instructions can result in minor personal inju ries The icon in front of the alert identifies the nature of the caution The exclamation mark denotes a general caution Note Identifies an important note or an instruction that you always must observe Tip Identifies an important recommendation Bo gt P 1 5 2 Typographical and authoring conventions e Listings and enumerations without prescribed order are always preceded by a bullet Steps in a procedure that must be performed in consecutive order are always numbered 1 6 Service and support For information about use operation cleaning verification maintenance and troubleshooting that is beyond the scope of this document please always contact MediSpirit BV MediSpirit BV De Pinckart 24 5670 AA Nuenen The Netherlands http Awww medispirit eu info medispirit eu 0050 002 0020 06 3 AS General information WHISTLER 1 7 Protection of the environment Please observe all local regulations and recommendat
20. art the application The internal Bluetooth of the computer is switched off Do the following actions 1 Close the application enable the internal Blue tooth of the computer or use the supplied Blue tooth dongle 2 Restart the application The internal Bluetooth of the computer is incompatible with the instrument Disable the internal Blue tooth of the computer and use the supplied Bluetooth don gle No instrument is selected Trying to connect with the wrong instrument check the cradle serial number Do the following actions see section 5 2 2 1 Select tools gt Blue tooth settings 2 Press Discover 3 Wait until all available Bluetooth devices are dis played 4 Select the cradle serial number of the instrument 5 Press Connect 6 The cradle serial number is displayed on the status bar 56 0050 002 0020 06 aS WHISTLER Troubleshooting Problem Possible cause Solution Bluetooth communication fails No sensor connected to the cradle Sensor is not properly attached to the cradle Attach the sensor see sec tion 4 1 and try again Dust or fluid is present on the connection pad of the sensor or between the pins of the cradle Clean the outside of the cra dle and the sensor see sec tion 6 2 One or more pins of the cra dle are bent or multiple pins make contact with each other Return to manufacture
21. cessssnseeeeeeesesseeeeeeeeessssseeeeeenens 10 31 Operational 2 raue aan 10 3 2 Storage and transport 10 4 Gradle 2 22 0 ernannte 10 4 1 B tlery uun ass anal 10 4 2 Ultrasonic transducer z 10 4 3 Bluetooth chip ssssssessssssssssssresesnsernssstrnsssrnnsinnsttnnsrnnnnnnnstnnnnnnnnnennn 10 5 Sensors laiiakihn 10 5 1 SOT Rint sensor 10 6 Accessories 10 7 Spare parts 10 8 Disposables Appendix 11 1 Conversion Sl units imperial Units 0 0 0 2 ccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeeetes 69 0050 002 0020 06 aS WHISTLER General information 1 General information 1 1 Intended users This document is exclusively intended for professional qualified users of the Whistler Lung Function Measurement instrument Whistler LFMi As a user you are either a trained medical specialist on pulmonary diseases a trained paediatrician a trained general practitioner or a trained medical assistant 1 2 Intended use of the Whistler LFMi The Whistler LFMi is a state of the art lung function measurement instrument that has been exclusively designed to measure calculate and present lung function parameters in a hospital environment see chapter 3 The Whistler LFMi does not produce any diagnosis Therefore the interpretation of the results of the measurements and the deduction of conclusions from these results always remains the responsibility of the medical specialist The medical specialist has t
22. connected 0050 002 2000 0006 0x30 04810 reading 1 W User admin 1 Consult the Rint measurement screen Live flow volume and pressure data is displayed on the screen The number of occlusions appears in the Occlusion counter field 2 After the defined number of successfull occlusions click on the Stop button to display the Rint result screen Data is calculated after each automatic occlusion and appears in the result table below the plots Tip Pressing Reset Zero Flow zeroes the sensor again This can be done if there is no actual flow through the device and the volume is still drifting too much Note Test Occlusion can be pressed for demonstrating the occlusion to the patient and getting familiar with the occlusion 40 0050 002 0020 06 a gt WHISTLER Lung function measurements 5 4 5 Rint result screen During the measurement the software analyses the occlusion which may take several seconds The Rint result screen offers an off line inspection of the measurement results Per occlusion one measurement result tab is available Tip The Rint result screen appears either when you click the Stop button in the Rint measurement screen after the defined number of successfull occlusions or when you select the Rint R button in the tool bar FA Whistler Spirometry Software Patient John Doe 01 01 2012 ING gi oT BINT sor min BAR 2 26 10 2012 17 53 24 warts nee sa SSS ee a Flow
23. d see if the vol ume curve stops drifting away 2 Verify the entered ambi ent conditions Flow too low for the selected measurement Configuration configured too strict Zeroing of the sensor has failed Do the following actions 1 Check if the POS indica tion toggles during each breathing cycle other wise no automatic occlu sions can be generated 2 Ask an administrator to adjust the measurement settings Measurement was paused Resume the measurement Occlusion mechanism fails Internal electronics defect e Internal mechanical defect Perform a manual occlusion to see ifthe occlusion mecha nism works Return to manufacturer for repair see section 1 6 0050 002 0020 06 59 Troubleshooting WHISTLER Problem Possible cause Solution Leak through the valve during occlusion SOT Rint sensor only The occlusion valve is not installed properly or is missing The end cap is not installed properly or is missing Verify the occlusion valve and the end cap see section 6 5 17 The occlusion valve is bro ken Do the following actions 1 Remove the occlusion valve and verify for possi ble defects 2 Replace the occlusion valve if needed spare part no CCM 0014021 1007 3 Pressure is too high outside specification Do not forcefully breathe through the instrument just breathe normally Shutter knife defectiv
24. e Return to manufacturer for repair The occlusion valve collapses on breathing in SOT Rint sensor only The occlusion valve is not installed properly Inhaling flow is too high out side specification Verify the occlusion valve and end cap see section 6 5 17 Do not forcefully breathe through the instrument just breathe normally 60 0050 002 0020 06 aS WHISTLER Troubleshooting Problem Possible cause Solution The red error indicator is on and the buzzer generates a beep The red error indicator remains on after the instru ment has been connected The inspiration path of the patient is blocked or valve collapses on breathing in e Expiration path of the patient is blocked e User inhales while the shutter is closed Do the following actions 1 Remove the instrument from the patient 2 Inspect the event history to see which errors have occurred Shutter is not in the default position e Shutter is manually opened by the user Do the following actions 1 Return the shutter to the open position 2 Inspect the event history to see which errors have occurred e Shutter error remains active Shutter sensor is broken Internal error inside the instrument Do the following actions 1 Inspect the event history to see which errors have occurred 2 Return to manufacturer for repair when appropri ate see section 1 6 Do
25. e section 70 6 Insert the brush A in both ends of the sensor Note Regularly check the condition of the brush Immediately replace the brush when hairs fibres or other particles come loose 6 5 6 Clean the sensor with the soap sol 1 Place a clamp B on the extremity of the occlusion valve For the specifications on the clamp see section 10 6 2 Fill a syringe A with the soap solution 3 Spray the soap solution into the empty space of the sensor 4 Keep your thumb on the hole Shake the sensor 6 Remove the clamp to allow the soap solution to run out a 0050 002 0020 06 Cleaning instructions N ution Cleaning instructions 7 Cleanse the inside of the sensor with clean water A in order to remove rests of soap Note Visually check that both the inside and the outside of the sensor are thor oughly clean If not clean the sensor once again 6 5 7 Disinfect the sensor with ethanol 1 Rinse the inside of the sensor with a 70 ethanol solution Use a syringe A CAUTION Inspect the suction cups for possible damage Verify that the pressure channels are not obstructed 6 5 8 Remove the occlusion valve 1 Gently pull the occlusion valve A off the sensor end B CAUTION Inspect the occlusion valve for possi ble damage 2 Clean the exposed parts with a ragfree cloth moistured with a 70 ethanol solution 48 WHISTLER H O
26. eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaee 8 2 5 When you use the Whistler LFMi cccecceseeeeeeeeeeeeeeeeeeeeeaeeeseneeeeeneeeeeeee 8 2 6 When you have used the Whistler LFMi c ceesceeeeeeeeeeeeeeeteeeeeeeseeeeeee 8 General description 3 1 Ch ratteristies cenense een anerkennen 9 32 Main c omponents 2 e ei 3 2 1 Cradle and Sensors 3 2 2 Error indicator and battery status indicator 32 3 Gradienten een x 3 24 SOT RINUCSENSON nee aan 3 2 5 Accessories required for the measurements 2240sn nennen 15 Preparations for use 44 EXch ngeithe sensor a 16 4 2 Charge the b ltleny enanneeieiesaseenekiei adii eit 18 4 3 Place the Bluetooth dongle cccccececceeeeseeeteeeceeeeeseeeseeaeeeeeneeeeeeneeeteeaeeeees 18 Lung function measurements 5 1 Prepare the Whistler LFMi application c cceecceeeeseeeeeeeeeeeeeneeeeeneeeeeeaee 19 5 1 1 Logon 0050 002 0020 06 aS WHISTLER 5 1 2 Menu bar Tool bar and Status bat ccccccccccesssseceeeeesessteeeeeeeeeeees 21 5 13 Patient scteen a u een 24 5 1 4 Measurement data screen uuseeeesssssssnnennnessnennnnnnnnnnnnnnnnnnnnnenennnnnn 25 5 1 5 Device information screen uueeeesessssnsnnsnnnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 27 5 2 Start the Whistler LFMi ccccccccsscccssssccessseecessseccesseeccesaeecessseecesssteeesaaees 28 5 2 1 Switch the Whistle
27. ersion of this document at your disposal Carry out the procedures in the order given Do not change the order of the steps Keep this document in a safe place near the Whistler LFMi This document must be accessible at all times 2 3 Decals and instructions on the Whistler LFMi Decals and instructions fitted on the cradle or on the sensors see section 2 3 1 and section 2 3 2 respectively are part of the safety features provided These items must remain present and legible 0050 002 0020 06 AN WHISTLER Safety instructions 2 3 1 Decals and instructions on the cradle P CN a CE Bluetooth 2 3 2 Decals and instructions on the sensors N CE T A 0050 002 0020 06 7 AS Safety instructions WHISTLER 2 4 Before you use the Whistler LFMi Make sure that unauthorised persons have no access to the working area Make sure that the working area meets all local requirements that are applicable for the use of medical devices lighting ventilation ambient temperature relative humidity hygiene etc Check the condition of the Whistler LFMi Check that the sensor has been cleaned and stored properly Do not use the instrument when the interior of the sensor is humid Check the instrument on broken parts Do not use the instrument when a sensor has fallen on the ground Check that there are no small objects inside the flow sensor Make sure that the Whistler LFMi battery is charged
28. face mask For each patient use the correct size of face mask 38 WHISTLER 0050 002 0020 06 aS WHISTLER 2 Gently place the face mask A over the nose and the mouth of the patient A 3 With the flat of your hands gently press the cheeks CAUTION Make sure that the face mask fits closely without air going past the face leakage Tip During the measurement the child must breathe normally Try to distract the child to calm it down Tip An automatic occlusion may cause the face mask to be lifted on the inflatable edge This causes incorrect pressure signals Gently push the face mask down in order to prevent this The inflatable edge must be inflated half full of the patient This prevents oscillation of the cheeks which can influence the measurements 0050 002 0020 06 Lung function measurements 39 A Lung function measurements WHISTLER 5 4 4 Rint measurement screen The Rint measurement screen appears as soon as the Whistler LFMi is configured for the Rint measurement The screen displays the course of the measurement RINT Session Reset Zero Flow Test Occlusion Pause Tenet SOT RINT Tube attached 156 0000 40 5593 95 9522 326 3235 159 5000 36 2710 94 5803 276 1765 1 0939 53 4973 65 8000 39 4290 92 9262 272 5000 0 0364 4 8906 11 4737 2 2628 3 3567 45 5219 Device is
29. further 50 WHISTLER 0050 002 0020 06 OS WHISTLER 7 Check that the occlusion valve is wide open Fit the end cap Check once more the position of the occlusion valve The occlusion valve must be correctly positioned with respect to the end cap 6 5 11 Check the sensor final check 1 Give a blow through the sensor Remove possible ethanol vapours left behind inside the sensor CAUTION Always use a bacterial filter when blowing through the sensor Check the suction cups A for humidity If necessary give a blow through the pressure slots 0050 002 0020 06 Cleaning instructions SS 51 Verification WHI STLE R 7 Verification 7 1 General ERS recommends to perform a daily verification of the flow sensor with a volume calibrated syringe For the ultrasonic measurement principle this is not really necessary It is however advised to do it on a regular basis 7 2 Preparation 1 Attach the flow sensor to the calibrated syringe and make sure that there is no leak between the syringe and the sensor Tip o If necessary use Teflon tape or similar to improve the fitting 52 0050 002 0020 06 a gt WHISTLER Verification 7 3 Verification test 1 2 3 4 Power on the Whistler LFMi Verify that the instrument is connected properly Verify the ambie
30. g on the cradle and gently pull ing back the shutter to gener ate an error The beep is muted by the user by shortly pressing the ON OFF button After a default waiting time of 1 minute the buzzer is ena bled again 62 0050 002 0020 06 oS WHISTLER Maintenance 9 Maintenance 9 1 General We recommend returning the instrument to the manufacturer or the distributor for an annual verification of the calibration inspection of the valve mechanism replacement of the batteries and for important firmware updates 0050 002 0020 06 63 WHISTLER Technical specifications 10 Technical specifications 10 1 Standards The Whistler LFMi is compliant with the standards listed below Standard Additional info ISO 13485 2012 Medical devices Quality management systems Requirements for regulatory purposes ISO 60601 1 2007 and C1 2007 C2 2007 C11 2010 A11 2011 Medical electrical equipment Part 1 General requirements for basic safety and essential per formance ISO 60601 1 1 2001 Medical electrical equipment Part 1 1 General requirements for basic safety and essential per formance Collateral standard Safety require ments for medical electrical equipment IEC 60601 1 2 2007 C11 2010 EN 980 2008 Medical electrical equipment Part 1 2 General requirements for basic safety and essential per formance Collateral standard Electromagnetic compatibility
31. he Patient screen appears see section 5 1 3 9 20 0050 002 0020 06 aS WHISTLER 5 1 2 Lung function measurements Menu bar Tool bar and Status bar The Menu bar Tool bar and Status bar are available in all screens Depending on the context some menu items or functions may not be selectable Menu bar The Menu bar is the upper part of the screen File View Tools Help Menu Menu item Function File menu Archive database Opens the browser to enable you to save the measurement results in a folder The results are saved as a mdb file See the Software installa tion manual Whistler LFMi Logon as a different Log off first when e g an administrator has user logged on to allow another user to log on Exit Exit the application View menu Patient Opens the Patient screen see section 5 1 3 Visit Opens the Measurement data screen see sec tion 5 1 4 Start SOT Session Opens the SOT measurement screen see sec tion 5 3 3 Start Rint Session Opens the Rint measurement screen see sec tion 5 4 4 SOT Result Page Opens the SOT result screen see section 5 3 4 Rint Result Page Opens the Rint result screen see section 5 4 5 Tools menu Settings Opens the Service menu only accessible for advanced users Bluetooth settings Opens the Bluetooth settings for connecting with other cradles see section 5 2 2 Report Template Opens the Report Template Designer only Designer accessib
32. he ability to diagnose and prescribe medications or to do further medical research 1 3 About this document With the help of this document you will become familiar with the Whistler LFMi and its features so that you are able to use operate and clean the instrument in an efficient hygienic and safe manner Therefore this document provides the following information important safety aspects during use operation and cleaning see chapter 2 a description of the main components and the measurements see chapter 3 preparations for use see chapter 4 procedures for the lung function measurements see chapter 5 periodic cleaning tasks see chapter 6 e verification procedures see chapter 7 basic troubleshooting tips see chapter 8 basic maintenance instructions see chapter 9 technical specifications of the Whistler LFMi see chapter 70 Note i Before you use or operate the Whistler LFMi make sure that you read and fully understand the contents of this document Strictly observe the instructions given 0050 002 0020 06 1 AS General information WHISTLER 1 4 Available technical documentation on the Whistler LFMi The table below shows the available technical documentation on the Whistler LFMi the document ID numbers and the contents per document Table 1 1 Technical documentation on the Whistler LFMi Document name Contents Document ID User manual Whistler LFMi Operation cleaning and 0050 00
33. ient conditions were not updated recently the Ambient Condition popup will be displayed 4 Check the ambient data and actualize zum the ambient data when needed Ambient Conditions Note Temperature Ifthe ambient pressure can not ne be measured most of the times null it is also possible to search the actual ambient pressure on line from a local weather station Pressure 1020 hPa 26 0050 002 0020 06 WHISTLER Lung function measurements 5 1 5 Device information screen Once the Whistler LFMi has been properly detected it is possible to click on the Device Information button in the tool bar to get additional information on the attached cradle and sensor x SOT RINT SOT RINT 4 R RSG N Whistler SOT RINT Sensor 2 48 EEE C 7 or 23 detected OK Device is connecte 0050 002 2000 0000 030004800 reading W User admin BIC 29 RH 1020 0nPa 0050 002 0020 06 27 AS Lung function measurements WHISTLER 5 2 Start the Whistler LFMi 5 2 1 Switch the Whistler LFMi ON 1 Prepare the Whistler LFMi as described in chapter 4 a Make sure to place the correct sensor b Make sure that the Bluetooth dongle has been plugged in or use the internal Bluetooth of the PC 2 Press the ON OFF button A The red error indicator B goes ON and will go out after succesfull communication with the Whistler LFMi application 3 Check the battery status indicator C If the battery status indicator remain
34. ions for the disposal recycling or environmentally friendly processing of parts and materials that have been used or replaced during the tasks described in this document 1 8 Abbreviations The following abbreviations are used throughout this document The abbreviations are defined upon first use except in a title Table 1 2 Abbreviations Abbreviation Definition ATS American Thoracic Society ERS European Respiratory Society LFMi Lung Function Measurement instrument Rint Resistance by interruption SN Serial Number SOT Single Occlusion Technique 1 9 Identification of the Whistler LFMi The Whistler LFMi is provided with the following type plates one type plate on the cradle see section 1 9 1 one type plate on the SOT Rint sensor see section 1 9 2 4 0050 002 0020 06 aS WHISTLER General information 1 9 1 Type plate on the cradle C IN 5V 500mA BUILT IN Li Polymer battery 3 7V 1 8Ah CCM Centre for Concepts in Mechatronics bv De Pinckart 24 5674 CC Nuenen The Netherlands whistler ccm nl Product name Cradle serial number Manufacturer Input voltage Battery specifications moou gt 1 9 2 Type plate on the SOT Rint sensor SOT RINT SENSOR SN 0050 002 3000 NNNN i CCM Centre for Concepts in Mechatronics bv De Pinckart 24 5674 CC Nuenen The Netherlands whistler ccm nl A Product name B Sensor se
35. k on the New button b Fill in the required fields Fields that are required will be marked with a red bar c Click on the Save button to save the patient file 3 Upon selection of the patient click on one of the measurement buttons on the tool bar The Measurement data screen appears see section 5 1 4 24 0050 002 0020 06 WHISTLER Lung function measurements 5 1 4 Measurement data screen Note The Measurement data screen is identical for all types of measurement Fie View Tools Help DA Default facemask 1 Default fiter 1 Start Session Close OK TU eves connecteaio050 002 2000 0006 030104800 reading 1 W User admin 330 20 RH 102000 1 Inthe Measurement data screen fill in the required fields Note The baby must be asleep during SOT measurements To avoid to disturb the sleep it is possible to mark the values for weight and height as estimated After measurement access the Results screen to enter the measured weight and height 2 Switch the Whistler LFMi ON and wait for the instrument to connect see section 5 2 1 3 Click on the Start Session button to start the actual measurement See one of the following sections section 5 3 for the SOT measurement e section 5 4 for the Rint measurement 0050 002 0020 06 25 ON Lung function measurements WHISTLER Depending on the type of measurement that was selected the corresponding measurement screen is started Note i If the Amb
36. le for advanced users Calibration check Opens the Verification screen see chapter 7 Help menu Help Opens the Help menu see the Software installa tion manual Whistler LFMi About Information about the Whistler LFMi software version 0050 002 0020 06 21 AS Lung function measurements WHISTLER Tool bar The Tool bar is the part of the screen just below the Menu bar TOT RINT SOT RINT 4 R R C4 IN Button from left to right Function Patient button Opens the Patient screen see section 5 1 3 SOT button Opens the SOT measurement screen see section 5 3 3 Rint button Opens the Rint measurement screen see section 5 4 4 SOT R button Opens the SOT result screen see section 5 3 4 Rint R button Opens the Rint result screen see section 5 4 5 Device Information button Opens the Device Information screen see section 5 1 5 Service button Opens the Service menu only accessible for advanced users Help button Opens the Help menu see the Software installation man ual Whistler LFMi Status bar The Status bar is the bottom part of the screen E There are items in Event History Device is connected 0050 002 2000 0006 User admin gt BEOECHZEIRRHNDZOONDEN Status bar item from left to right Information Battery information The text describes the battery status Unknown No device connected Ok Battery is ok LowBattery Battery is low
37. lusion to the patient and getting familiar with the occlusion 32 0050 002 0020 06 a gt WHISTLER Lung function measurements 5 3 4 SOT result screen During the measurement the software analyses the occlusion which may take several seconds The SOT result screen offers an off line inspection of the measurement results Per occlusion one measurement result tab is available Tip The SOT result screen appears either when you click the Stop button in the SOT measurement screen after the defined number of successfull occlusions or when you select the SOT R button in the tool bar Patient John Doe 01 01 2012 SOT RINT SOT RINT lt 7 R r 4 2S Volumefml 38 0000 2 4210 pst an foszso zz fp arestas anus ooon fsa sr 0 Device is connected 0050 002 2000 0006 0x30 04810 reading 1 W User admin Consult the SOT result screen Click on the Export button to export the results of the complete measurement Print report button to print the measuring results of the current tab e Patient button to return to the patient screen N 0050 002 0020 06 33 AS Lung function measurements WHISTLER Note i The pull down menu in the SOT result screen enables the selection of the individ ual measurements Tip Pressing on the plot zooms in on the selected
38. n 3 2 4 Cc ON OFF button Pushbutton ON press 1x OFF keep pressed for 3 seconds D Sensor release buttons Buttons on both sides of the sensor to release the sensor from the cradle E USB port USB port to charge the Whistler LFMi F Reset switch Enables to power down the Whistler LFMi by pressing a small pointed object e g a paperclip into the hole 0050 002 0020 06 11 General description WHISTLER Position Definition Description number G Connection for face Connection end for the disposable face mask or the mask or bacterial filter disposable bacterial filter that is used for the measure ments H Error indicator Red indicator that lights up when the valve blocks or when the internal occlusion valve closes unintention ally see section 3 2 2 Battery status indicator Green indicator that indicates the battery status see section 3 2 2 Slow blinking charging only when USB is con nected e Flashing the battery is almost empty J Running indicator Indicator that lights up when the Whistler LFMi is con figured for the selected measurement K Internal buzzer The internal buzzer generates an alarm to alert the user that intervention may be required 3 2 2 Error indicator and battery status indicator 12 Error indicator Battery status indicator 0050 002 0020 06 OS WHISTLER General description 3 2 3 Cradle
39. nnnannnnnnnnnnnnnnnnnnnennnnnnnnnn 44 6 5 Clean the inside of the S MSOM ccceececeseeeeeeeeeeeecaeeeseaeeeeteaaeesteaeesessaeees 44 6 5 1 Decision tree 6 5 2 Remove the end cap of the sensor u0rsnennsnnsennnnnnnnnnnnnnnnn 46 6 5 3 Rinse the sensor with clean water u0snnsnnnnnnnnnnnnnnnnnnnnnnn 46 6 5 4 Prepare the Soap solution 400rssnsennsnnnnnnnnnennnnnennnnnannnnnnnnnn 46 6 5 5 Clean the sensor with a DrUSN ccccceeeeceeseeeeeeeeeeeeeeeeeeeeneeetenaeees 47 6 5 6 Clean the sensor with the soap solution u 2240snseneennnnennnnn 47 6 5 7 Disinfect the sensor with ethanol cccccececeeeeseeeeeeeeeeeseneeeeeneeees 48 6 5 8 Remove the occlusion valve uuussssnsnssnnensnnnennnnnnnnnnnnnnnnnnnnnn 48 6 5 9 Dry the SONSOl ss nina 49 6 5 10 Install the occlusion valve 20nssneennsnnnnnsnnensnnnnennnnnenennnnn 49 6 5 11 Check the sensor final check 2240ss4440nnnnnnennnnnnnnnnnnnnn 51 Verification 1 1 Gener le hen alien 52 7 2 Preparation 52 71 3 Venfication testisa ene ne 53 Troubleshooting 8 1 Troubleshooting tableros nenne 55 Maintenance 10 11 vi WHISTLER 9 1 IGMP al EESE ESEE AE tie ine esate nina drite 63 Technical specifications 10 1 Standards een 10 2 Dimensions and weight 10 3 Environmental Conditions ccccccccccccssscecece
40. nt conditions see section 5 1 4 Update the data if the ambient conditions have changed Note The reference conditions are loaded from the internal memory of the flow sensor As a consequence they do not need to be changed Select Calibration check in the Tools menu see section 5 1 2 Set the parameters and then start Calibration syringe volume Remaining Time Ambient conditions Temperature C Flow signal disabled Humiclty Correction 0 979 Barometric Pressure Reference conditions Temperature c Humityl Barometric Pressure Results Device is connected 0050 002 2000 0006 0x30048 0 reading 1 W User admin Select the volume of the calibration syringe Pull out the syringe plunger as far as possible and press the Start button First the sensor is zeroed again so do not generate any flow After the sensor is zeroed the message lt lt Generate flow out in gt gt is displayed Gently move the syringe plunger fully in and fully out at different speeds for testing multiple flow ranges 0050 002 0020 06 53 Verification WHI STLE R 10 54 Note i The smoothness of the generated flow can be increased by slightly twisting the handle of the syringe while moving The measured data is displayed in the plot Each cycle will be analysed and the expiration and inspiration volume are being calculated After a fe
41. pressure 850 to 1060 hPa 10 3 2 Storage and transport Item Specification Temperature range 25 to 70 C Relative humidity 30 to 95 Air pressure 850 to 1060 hPa 10 4 Cradle 10 4 1 Battery Item Specification Battery type 2x Li Polymer 3 7 V 900 mAh Battery consumption parallel mode 500 occlusions of 500 ms Charging time 5 V 500 mA approx 5 6 hours 160 mA 0050 002 0020 06 65 Technical specifications 10 4 2 Ultrasonic transducer WHISTLER Item Specification Resonance frequency 40 kHz 10 4 3 Bluetooth chip Item Specification Chip type BlueGiga WT12 Bluetooth Class II Bluetooth 2 1 EDR 2 4 GHz ISM band Working range lt 10m 10 5 Sensors 10 5 1 SOT Rint sensor Item Specification SOT Rint sensor Sample rate 160 Hz Flow range inhale 1250 ml s exhale 2000 ml s Flow resolution 1 ml s Flow accuracy 2 5 or 2 5 ml whichever is greater Flow linearity lt 2 ml s Dead volume lt 11 ml Resistance Inhaling 100 ml s 0 12 kPa s L Inhaling 300 ml s 0 11 kPa s L Exhaling 100 ml s 0 16 kPa s L Exhaling 300 ml s 0 15 kPa s L Pressure sensor in cradle Sample rate 1600 Hz Pressure range 6 895 to 6 895 kPa Pressure resolution 0 002 kPa Pressure accuracy 1 Pressure linearity lt 0 1kPa
42. r LFMi ON c cccccsccccsscccessseecssssecesseeeeessseeeess 28 5 2 2 Set up Bluetooth communication 400s4snnsnnnnennennnnnnennnnnennn 29 5 3 SOT MeasureMment naahienieniidefrtekkilensnesnlaskaahtnle 30 5 3 1 SOT measurement principle 2200snnsnnnnnnensnnnnnnnnnnnnnennnnnnnnn 30 5 3 2 Use the face mask 31 5 3 3 SOT measurement screen cccccccceeccesnseeeeeeeesssteeeeeeeeeesestseeeeeeeeeses 32 5 3 4 SOT result screen uesssunessssssnnnennnnsnnnnnnnnnnnnnnnnnnnnnennnnnnennnnnnnnnnnennnnnn 33 5 4 Rint measurement 40unrsnnsunsnnnnonnnnnnnnnnnnnnnnnnnnnnnnnnonnnnnnnnnnnnnonannnnannnnnnnann 35 5 4 1 Rint measurement principle cccceecceeceeeeeeeeeeeeeeeeeeeeeeeseneeeeeeneeeees 35 5 4 2 Use the bacterial filter ae tattvlacas eiaa 37 54 3 Use the face ask vececczeccscsccscciciiswve eccadcavesaleiatecsesessecbisvecsabscoudet daassbevs 38 5 4 4 Rint measurement screen cccccccceceeessseeeeeeeeeeeeseeeeeeeeesestsaeeeeeeeeees 40 5 4 5 Rint res lt screen a aaseanneenananee ein ann 41 6 Cleaning instructions 9 0050 002 0020 06 6d Pr amp parati n lesen teens E a eeewearatiesssee eects 43 6 2 Clean the outside of the Whistler LFMi c ceceeseceeeeeeeeeeeeeeeeseeeeeeneeees 43 6 3 lnspecttheimanifold 2 en een ae es 44 6 4 Clean the filter adapter 220usn240unnnnnnnnnnnnnnn
43. r for repair see section 7 6 Communication is disturbed by another device Switch off the other device Distance between PC and cradle to large or blocked by objects Move closer or remove block ing objects Flow stays zero has an off set or looks unstable Leakage around the face mask filter mouthpiece Verify the position of the face mask filter mouthpiece Zeroing of the sensor has failed Do the following actions 1 Place the sensor on the table 2 Press Reset Zero Flow Sensor not properly attached to the cradle Sensor was disconnected while still powered on Bad electrical contact between cradle and sen sor Do the following actions 1 Power off the instrument 2 Verify the electrical con nectors and clean if nec essary 3 Reconnect the sensor Power on the instrument 5 Listen through the sen sor 6 Check for the presence of a humming sound gt Internal electronics defect Do the following actions 1 Verify the calibration of the sensor 2 If calibration fails return sensor to manufacturer for repair see section 1 6 0050 002 0020 06 57 Troubleshooting WHISTLER Problem Possible cause Solution Pressure stays zero has an offset or reacts slowly SOT Rint sensor only Leakage around the face mask filter mouthpiece Verify the position of the face mask filter mouthpiece
44. rial number C Manufacturer 0050 002 0020 06 5 AS Safety instructions WHISTLER Safety instructions 2 1 General The operational cleaning verification maintenance and troubleshooting tasks described in this document are strictly reserved to users who have completed the training sessions and who are acquainted with all safety instructions mentioned in this document The manufacturer accepts no liability for any damage or physical injury caused by non compliance with the safety instructions in this document or by carelessness during use cleaning verification maintenance and troubleshooting of the Whistler LFMi Depending on the working conditions in your specific environment additional safety instructions may be applicable As the manufacturer has no direct control over these working conditions it is your sole responsibility to ensure that the local Health and Safety regulations are adhered to Please inform the manufacturer immediately if you have dealt with unsafe situations that have not been described Only use the Whistler LFMi for the purpose defined in section 7 2 Do not sterilize the Whistler LFMi The instrument is not suitable for sterilization Never modify any part of the Whistler LFMi Do not use the Whistler LFMi when parts are missing or when technical malfunctions occur 2 2 This document Read this document thoroughly before you perform any of the tasks described Make sure that you always have the latest v
45. rts Tip i Please see the website www medispirit eu for the actual list and the procedures on obtaining spare parts or ordering disposables Item Ordering number Occlusion valve CCM 0014 021 1007 3 Cradle CCM 0050 002 2000 x Sot Rint Sensor CCM 0050 002 3000 x Filter adapter CCM 0014 021 1011 2 10 8 Disposables Tip i Please see the website www medispirit eu for the actual list and the procedures on obtaining spare parts or ordering disposables Item Ordering number Face mask T B D Spiro filter Piston medical PBF 100 G Nose clip T B D 68 0050 002 0020 06 aS WHISTLER 11 Appendix Appendix 11 1 Conversion Sl units imperial units Table 11 1Conversion Sl units imperial units Sl units gt imperial units Imperial units gt SI units 1 mm 0 03937 in 1 in 25 4 mm 1 cm 0 3937 in 1 in 2 54 cm 1 kPa 0 010 bar 0 145037738 Psi 1 psi 6 89475729 kPa 0 0689 bar 11 0 264172051242 US gallon 1 US gallon 3 79 Celsius x 1 8 32 Fahrenheit 1 kg 2 2046 Ib Fahrenheit 32 1 8 Celsius 1 Ib 0 453592 kg 0050 002 0020 06 69 Medispirit De Pinckart 24 5670 AA Nuenen The Netherlands http www medispirit eu
46. s continuously ON the battery condition is OK If the battery status indicator flashes the battery must be charged 4 Set up Bluetooth communication when a cradle is used for the first time see section 5 2 2 5 After succesfull configuration the LED ring D will be switched on 28 0050 002 0020 06 a gt WHISTLER Lung function measurements 5 2 2 Set up Bluetooth communication Note Set up is only needed once Subsequent connections are automatically 1 Select Bluetooth settings on the Tools menu see section 5 1 2 Dr ae 2 Wait for the Bluetooth window to appear sr estar eile pak 3 Click on the button Discover Bluetooth devices in Range 3 0050 002 2000 0006 4 Wait until all available Bluetooth devices 0050 002 2000 0014 are displayed 5 Click on the serial number of the device to connect to 6 Click the connect button Note The status bar see section 5 1 2 shows the serial number when communication is estab lished 7 Check that the serial number is displayed in the Status bar see section 5 1 2 8 Consult chapter 8 when set up fails 0050 002 0020 06 29 ON Lung function measurements WHISTLER 5 3 SOT measurement 5 3 1 SOT measurement principle WARNING According ERS ATS standards babies with a weight less than 5 kg are not to be measured with this instrument due to the dead space of the SOT Rint sen sor CAUTION Always use a transparant face ma
47. serve the safety instructions in chapter 2 6 1 Preparation 1 Before you clean the Whistler LFMi or the accessories thoroughly wash your hands or use disposable gloves 2 Make sure that your working area is clean 6 2 Clean the outside of the Whistler LFMi Note il Before you clean the outside ofthe cradle and the sensor e Switch the Whistler LFMi OFF Remove the sensor from the cradle 1 Clean the outside of the cradle A and the sensor B with a ragfree cloth moistened with a 70 ethanol solution CAUTION Be careful not to damage the contact pins of the cradle 0050 002 0020 06 43 AS Cleaning instructions WHISTLER 6 3 Inspect the manifold 1 Look inside the manifold A Verify that the pressure channels are not contaminated 6 4 Clean the filter adapter 1 Clean the filter adapter A after each patient a Put the filter adapter in a tray filled with a 70 ethanol solution b Rinse the filter adapter with clean water c Leave the filter adapter to dry during at least 10 minutes 6 5 Clean the inside of the sensor Note Before you clean the inside of the sensor Switch the Whistler LFMi OFF Remove the sensor from the cradle 44 0050 002 0020 06 WHISTLER 6 5 1 Decision tree Cleaning instructions Do the sensor need deanna Did you use the bacterial filter Remove the end cap of the sensor
48. sion may cause the face mask to be lifted on the inflata ble edge This causes incorrect pressure signals Gently push the face mask down in order to prevent this The inflatable edge must be inflated half full 0050 002 0020 06 31 A Lung function measurements WHISTLER 5 3 3 SOT measurement screen The SOT measurement screen appears as soon as the Whistler LFMi is configured for the SOT measurement The screen displays the course of the measurement SOT Session z Tels SOT RINT Tube attached Mean 0 0000 I 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 Stadev 0 0000 Jo 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 0 0000 Device is connected 0050 002 2000 0006 0x30 048 0 reading 1 W User admin 1 Consult the SOT measurement screen Live flow volume and pressure data is displayed on the screen The number of occlusions appears in the Occlusion counter field 2 After the defined number of successfull occlusions click on the Stop button to display the SOT result screen Data is calculated after each automatic occlusion and appears in the result table below the plots Tip Pressing Reset Zero Flow zeroes the sensor again This can be done if there is no actual flow through the device and the volume is still drifting too much Note Test Occlusion can be pressed for demonstrating the occ
49. sk so that the mouth and the nose of the baby remain visible and can be monitored A Cradle B SOT Rint sensor C Disposable face mask see section 10 7 for information on ordering this part 30 0050 002 0020 06 aS WHISTLER Lung function measurements The SOT measurement uses the Hering Breuer reflex that is typically present in babies in the age of 0 to approximately 12 months Compliance resistance and the time constant of the respiratory system can be calculated by measuring flow and pressure during a short occlusion period The figure shows the required configuration for the SOT measurement 5 3 2 Use the face mask 1 Connect the disposable face mask A to the Whistler LFMi CAUTION For each patient use a new face mask For each patient use the correct size of face mask Face masks that are too big increase the chances of air going past the face leakage Face masks that are too big have too much dead volume The baby will inhale too much CO Face masks that are too small will compress the nose and the mouth of the baby 2 Gently place the face mask A over the nose and the mouth of the baby CAUTION Make sure that the baby is asleep and has a normal breathing cycle Hold the baby in a horizontal position to keep the bronchial tubes free Make sure that the face mask fits closely without air going past the face leakage Tip il An automatic occlu
50. the disposable face mask can be used instead Note il The face mask the bacterial filter and the nose clip are disposable parts The filter adapter is not disposable and must always be cleaned after use 0050 002 0020 06 35 Lung function measurements Rint measurement with the bacterial filter WHISTLER yw gt Cradle SOT Rint sensor Disposable bacterial filter Filter adapter Disposable nose clip moou gt 36 0050 002 0020 06 WHISTLER Rint measurement with the face mask Lung function measurements eS B A Cradle B SOT Rint sensor C Disposable face mask 5 4 2 Use the bacterial filter 1 Assemble and connect the bacterial filter as shown Note The filter adapter A is no disposable Clean the filter adapter after use see section 6 4 The bacterial filter B is a disposable For each patient use a new bacterial filter 0050 002 0020 06 37 Lung function measurements 2 Gently place the nose clip A This prevents air leakage through the nose Tip i During the measurement the child must breathe normally Try to distract the child to calm it down 3 With the flat of your hands gently press the cheeks of the patient This prevents oscillation of the cheeks which can influence the measurements 5 4 3 Use the face mask 1 Connect the disposable face mask A to the Whistler LFMi Note For each patient use a new
51. w cycles the analysis stops and the results are displayed The test passes when the deviation from the averaged volumes is within specification and the text lt lt Calibration VERIFIED gt gt is displayed Press the Print button to generate the report If the verification test fails a b C d e Verify the selected volume from the calibration syringe Verify the entered ambient conditions Check if there is no leak between the sensor and the syringe Use another calibration syringe if there is an internal leakage in the syringe Repeat the verification test If the verification test fails again return the sensor to the manufacturer or to your distributor 0050 002 0020 06 aS WHISTLER Troubleshooting 8 Troubleshooting 8 1 Troubleshooting table Problem Possible cause Solution The instrument is damaged The instrument has been dropped Return to manufacturer for repair see section 7 6 Unable to power on red error indicator stays off and green battery status indicator stays off Unable to power off the instrument The internal battery is empty Charge the battery see sec tion 4 2 Firmware lockup Do the following actions 1 Disconnect all cables from the instrument 2 Press the reset button using a paperclip or simi lar to fully power off the instrument see section 3 2 1 Internal electronics defect ON OFF button not pressed long enough Return
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