CareFusion MicroLoop Operating Manual Rev 1.2 June 2016

II. Introduction – CareFusion USA... 55 Contraindications ...57 Warnings and Cautions ...57 Overview ...59 Indication for Use...61 Getting Started ...62 Calibration Check (Verification) ...72 Customization...74 Administration Mode ...76 Switching Off ...77 Charging Procedure ...77 PC connection using SPCS ...78 Looking after your Spirometer...79 Product Lifetime ...79 Disinfection with Perasafe...79 Cleaning Instructions ...80 External Surfaces of the Spirometer...80 Cleaning accessories...81 Cleaning the Transducer...81 Servicing ...82 Trouble Shooting Information...83 Safety Designation per IEC 60601-1 ...85 Electromagnetic Compatibility (EMC) to EN60601-1:2007...87 Symbols ...92 Specification of the MicroLoop ...93 Spirometry Measurements:...94 Consumables / Accessories ...97 Customer contact information ...99 III.

Introduction - Français... 102

Contre-indications ... 104 Avertissements et mises en garde ... 104 2

MicroLoop Operating manual I.

Introduction - English

The MicroLoop is a mains/battery operated portable spirometer with the unique combination of ease of use and sophistication. Ease of use is assured through the use of context sensitive help screens, accessed at a touch of a button, that explain every MicroLoop feature. The MicroLoop is supplied with a cradle that may be connected with the USB cables supplied, to either a PC or a printer. The cradle also connects to the mains adapter so that the MicroLoop’s batteries may be charged whilst it is placed in the cradle. The blue lights on the cradle indicate that it is being powered either by a PC connection or by the mains adapter. When either of these sources of power is connected to the cradle, it is ready to charge your MicroLoop.

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The MicroLoop uses the CareFusion Digital Volume Transducer, an extremely stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test. Test results may be uploaded to a PC using Spirometry PC Software and patient details may be downloaded to the MicroLoop.

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Contraindications  Acute disorders affecting test performance (e.g Vomiting , nausea, vertigo)  Recent eye surgery (increases in intraocular pressure during spirometry)  Oral or facial pain exacerbated by a mouthpiece  Recent myocardial infarction  Post- operative thoracic surgery patients  Hyperventilation syndrome Note: Extensive exhalation might lead to syncope

Warnings and Cautions The following terms are used as follows in this manual CAUTION: Possibility of injury or serious damage. WARNING: conditions or practices that could result in personal injury. Note: Important information for avoiding damage to the instrument or facilitating operation of the instrument. Note: Patients below the age of 4 may struggle to perform spirometry correctly and reproducibly. Note: The device should only be used by trained and qualified personnel.

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CAUTION: Read the manual before use.

WARNING: The instrument is not suitable for use in the presence of explosive or flammable gases, flammable anaesthetic mixtures or in oxygen rich environments. CAUTION: Mouthpieces are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may degrade materials and lead to an incorrect measurement. CAUTION: Pulmonary filters are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may increase air resistance and lead to an incorrect measurement. PLEASE NOTE:

The product and the battery you have

purchased should not be disposed of as unsorted waste. Please utilise your local WEEE collection facilities for the disposal of this product. PLEASE NOTE: Degree of protection against Ingress of Water is IPX0. WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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Overview

When the unit is turned on for the first time the system customise menu is displayed. Touch the name of the required region with the stylus stored on the left hand side of the unit and then touch ‘Finish’. This will set the regional defaults including language, if available. If this screen is not displayed then touch the ‘Customise’ icon on the main menu followed by the ‘System’ icon.

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The MicroLoop uses a touch screen with icons representing each function available. A stylus, housed in the left hand side of the unit, is provided for icon screen activation. Touch the displayed time to adjust time and date. Unused icons may be disabled by touching the blue background and selecting from the list displayed. Touch the toolbox icon to adjust volume and brightness. Four levels of battery charge are indicated by the segmented battery icon.

When this icon turns red the battery is nearly exhausted and the batteries must be charged – see Charging Procedure. The complete functionality is described on the help screen. This is obtained by pressing the help button (?). Help text exists for every screen viewed during the operation of the MicroLoop. You are recommended to make full use of the extensive Help screens provided.

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Indication for Use The Microloop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with paediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments. The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.

Note: Pulse Oximetry is an optional measurement mode. Therefore the sensor for pulse oximetry measurements is not part of the standard MicroLoop package and needs to be purchased separately.

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Getting Started

When performing a spirometry test the recommended workflow is to enter the patient’s details, or retrieve them from memory, perform the required test and then print and save the results.

Please ensure that the turbine transducer is plugged in to either of the first two sockets on the right hand side of the instrument.

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Touch the ‘Patients’ icon to enter the patient database. The required patient may be selected from the stored patient list. If the patient details have not been previously stored then touch Add to enter the new patient’s details. The patient details may also be downloaded from the optional SPCS software. Once selected, the patient’s name will appear at the bottom of the screen. Use the help button to obtain further information.

To add a patient to the database use the on screen keyboard to type a unique patient ID and then touch the enter key. You will then be prompted for Last Name, First Name, Sex, Ethnic Origin, Height, Weight, date of Birth and Factor. A factor can be applied when testing individuals of other ethnic origins who would not normally be tested against the countries set of predicted values eg ECCS predicted values are used but Non Caucasian individuals tested. The factor alters the predicted value set on volume indices by the percentage applied.

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The following factors are recommended when using ECCS normal values: Hong Kong Chinese

100%

Japanese American

89%

Polynesians

90%

North Indians and Pakistanis

90%

South Indians and those of African descent 87% Ref: Lung Volumes and Forced Ventilatory Flows. P.H.Quanjer et al. Eur Respir J, 1993, 6, Suppl. 16p5-40

Once all the patient details are added the patient is added to the database and the main menu is displayed with the patient name displayed at the bottom of the screen. From the main menu select the required test, by touching the icon with the stylus. If the displayed patient is not required for testing then touch the patients name and options to change or remove the current patient will become available

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If Relaxed Spirometry is selected then a volume/time graph will be displayed. Note that the unit may be customised to perform a relaxed Vital Capacity with tidal breathing or from a single expiration or single inspiration. When a manoeuvre has been obtained touch ‘Results’ to view the indices, ‘Again’ to repeat the manoeuvre, ‘Reject’ to delete the manoeuvre or ‘Done’ to end the test.

All the active indices are displayed for any of the manoeuvres selected together with an option to review the volume/ time curves. The active indices listed can be changed by using the customisation option. Select ‘Done’ to proceed Spirometry Main Menu.

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to

the

From this menu the results of the test may be viewed, saved, or printed and notes may be added. It is also possible to proceed to a forced baseline spirometry test, or a post medication relaxed spirometry test. Select ‘Exit’ when all functions have been used.

the

required

If forced spirometry is selected the default graph will be displayed. This may be changed by touching the arrows at the top of the screen. Flow/Volume, Volume/time or child incentive default displays may be selected using the customise option from the main menu. When the spirometry manoeuvre has been completed options to repeat the test, reject the test, and view results will be available. At the end of the test options to view results, save results, print results, and to add notes will be available from the spirometry main menu.

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‘Touch’ the MVV icon to select this mode of testing and the display will instruct the patient to start breathing hard to commence the test. It is recommended that the patient perform 3 tidal breathing manoeuvres prior to performing hard and fast rapid breathing (required for the MVV manoeuvre).

The patient should be instructed to tidally breathe. The tidal breaths are automatically detected prior to commencing the MVV manoeuvre.

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Once tidal breathing is complete the display will change and an audible beep heard to instruct the patient to start rapid fast breathing. The start button should be touched using the stylus to start registering the MVV manoeuvre.

The current manoeuvre will be displayed in black, during the manoeuvre the breath rate (BR) will be displayed in green if the breath rate is acceptable (> 65 breaths per min) if the breath rate falls below this level it will be displayed in red to show the operator that the patient needs to be instructed to breath harder and faster during the manoeuvre. After 12 seconds of hard, fast and rapid breathing the display will show a green line indicating 12 seconds of the manoeuvre have elapsed – the patient should be encouraged to continue until the display changes to signify the end of the test. The MVV rate, the % variation between manoeuvres the breath rate and an ATS quality warning for the manoeuvre will be displayed.

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Note: Patient efforts is acceptable when: Patient made a maxium effort. Indicated to the user by the breath rate being displayed in green (>65 breaths per minute). Lasted a full 12 seconds manoeuvre. Indicated to the user by a green line being displayed – the patient should ideally continue until the test is automatically terminated at 15s. Interruption ie. Did not cough.

Once the test has finished the display will show current test (shown in black – if more then one manoeuvre has been performed then the best manoeuvre will also be displayed in blue) the MVV rate, the % variation between manoeuvres the breath rate and an ATS quality warning for the test session. ‘Touch’ Again to repeat the manoeuvre, Reject to reject the current manoeuvre, Results to display a list of indices,the values obtained, % predicted where applicable and also a quality statement concerning the test session. To meet the ATS quality criteria for a Good blow the manoeuvre should last 15 seconds with a breath rate greater than 65 breaths per minute. The ATS reproducibility criterion is two manoeuvres with a Good Blow and the MVV variability between manoeuvres should not exceed 20%.

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Note: The MVV test is an exhausting test. It should not be repeated without a rest period. Some elderly or ill people cannot repeat this test even after the rest period.

‘Touch’ Back to return to testing and the current manoeuvre. Note: If the breathing rate is insufficient (less than 65 breaths per minute) then the BR value will be displayed in red – an MVV value will be calculated and a message displayed that the MVV result was extrapolated from a manoeuvre with a poor breath rate.

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Once the number of manoeuvres has been completed and the test session has finished selecte Done and the results with selected indices will be displayed. Each manoeuvre will be numbered and the best manoeuvre highlighted with an asterix (*). Touch Graphs to view the graphs of the currently selected manoeuvre and best manoeuvre. Select Set best to manually select the best manoeuvre. Select Done to return to the main MVV menu.

Once testing is complete the MVV main menu will be displayed ‘Touch’ the appropriate icon to allow a Post 1 MVV test to be performed, View Results, Print Results, Add notes for the patients examination, Save the tests or Exit to return to the main spirometer menu.

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Calibration Check (Verification) The spirometer is calibrated to read in litres at body temperature, Barometric Pressure Saturated with water vapour (BTPS). The calibration should remain stable indefinitely, unless the transducer is physically damaged, and the unit should not require re-calibration. However, to ensure the correct functioning of the unit we do recommend that a calibration check (verification) is performed after the transducer was removed for cleaning.

Connect a 3L syringe to the transducer with the minimum of adapters and empty by pushing the handle fully in. Note: It is receommended that the transducer is disinfected prior to a calibration check (verification) or a ® MicroGard filter is used during the

procedure. Select ‘Calibration Check’ from the main menu and then select ‘check Calibration’. Fill the syringe by pulling the handle at a constant rate until the end stop is reached and then immediately empty the syringe completely. Try to maintain a flow rate that keeps the trace within the grey bands on the display. Press ‘Reject’ to retry the calibration check (verification) at the required flow rate.

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