SpiroSense Instructions for Use July 2017

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Instructions for use Information as of: May 2017. All rights reserved. Technical and design changes and printing errors reserved. Principle shown in illustrations.

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IMPORTANT INFORMATION ...

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General... Information about the instructions for use ... Structure of safety instructions ... Using the device ... Hygiene ...

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PRODUCT DESCRIPTION...

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Components ... Product variants... Intended purpose... Intended use... Indications ... Contraindications... Material information ... Operating life ... Control elements ... Lung function parameters... Display symbols...

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APPLICATION...

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Preparing the device... Configuring the device... Taking a measurement with the patient's device... Electronic journal ...

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MAINTENANCE ...

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Changing batteries (patients' devices) ... Calibration ... Bioverification ... Replacing the measuring unit ...

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CLEANING AND DISINFECTION ...

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General hygiene instructions ... Frequency of cleaning and disinfection ... Preparation ... Cleaning and disinfecting the display unit ... Cleaning the other parts ... Disinfecting the other parts... Visual inspection... Drying and storage ...

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TROUBLESHOOTING ...

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TECHNICAL DATA ...

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General... Display... Measurement range (BTPS)... Accuracy... Resolution (device)... Resolution (SpiroSensePro software) ... Information about electromagnetic compatibility ... Ambient conditions ...

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MISCELLANEOUS...

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Disposal... Terms and conditions of warranty ... Explanation of symbols... Contact ... Journal for copying ...

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1

IMPORTANT INFORMATION

1.1

General Please read these instructions for use and all other instructions belonging to the product thoroughly. Do not discard, so you can consult them at a later date. If you fail to comply with the instructions for use, injury or damage to the device cannot be ruled out.

1.2

Information about the instructions for use These instructions for use are applicable for the product versions "mySpiroSense", "mySpiroSense Track" and "SpiroSensePro".

Symbols used – List item ► Required precondition for an action • Description of an action a Preliminary result of an action step Æ Result of an sequence of actions

Icons used Some of the functions described in these instructions for use are only available for certain product variants. These functions are identified with icons: mySpiroSense

my my

mySpiroSense Track

Track

SpiroSensePro

Pro For functions which require a connection to the SpiroSensePro software, please refer to the separate instructions for use of the software (SpiroSensePro software). For using the mySpiroSense Track, please refer also to the user manual for the 2net™ Hub, supplied separately by Qualcomm Life. If any instructions for use are lost, another copy can be requested from PARI GmbH.

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1.3

Structure of safety instructions Safety-critical warnings are categorised according to hazard levels in these instructions for use: – The signal word WARNING is used to indicate hazards which, without precautionary measures, can result in serious injury or even death. – The signal word CAUTION is used to indicate hazards which, without precautionary measures, can result in minor to moderate injury or impair treatment. – The signal word NOTICE is used to indicate general precautionary measures which are to be observed to avoid damaging the product during use.

1.4

Using the device The following points must be borne in mind when using the device: – If alterations or modifications are made to the device without permission or if unauthorised repairs are made, risk situations may arise. Such activities will be considered "misuse" and/or "negligence" within the meaning of the warranty for the product, and will consequently nullify the warranty coverage in the event of any damage resulting therefrom. All claims under the warranty will also be null and void. – The performance of the SpiroSense can be adversely affected by: – Saliva or the patient coughing into the measuring unit – Impermissible temperatures – Moisture – Excessive altitude – Additional devices that are connected to medical electrical devices must be proven to conform to the respective IEC or ISO standards (e.g., IEC 60950 for information technology equipment). Moreover, all configurations must satisfy the normative requirements for medical systems (see IEC 60601-1-1 or section 16 of the 3rd edition of IEC 60601-1 respectively). – The person who connects additional devices to medical electrical devices is the system configurator and is therefore responsible for ensuring that the system conforms to the normative requirements for systems. It should be noted that local laws have precedence over the abovementioned normative requirements. In case of enquiries, please contact your local specialist dealer or the Technical Service department. – It is recommended that children be assisted by an adult when using the SpiroSense. Cleaning should always be carried out by an adult. – The batteries in the mySpiroSense or mySpiroSense Track should be taken out of the device if it is not going to be used for more than a month.

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1.5

Hygiene Observe the following hygiene instructions: – Wash your hands thoroughly before every use and cleaning. – Make absolutely sure you also carry out cleaning before using the device for the first time. – Do not keep the device in a damp environment or together with damp objects. Contamination and residual moisture encourage the growth of bacteria, giving rise to an increased risk of infection. – The reusable mouthpiece must only be used in home environments. In professional environments, a mouthpiece with bacterial filter must be used together with an adapter. These mouthpieces are not reusable and must be discarded after each use.

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PRODUCT DESCRIPTION

2.1

Components The SpiroSense is available in the following product variants: – Devices for patients, for use in the home and professional environments: – mySpiroSense – mySpiroSense Track – Packages for doctors, incl. the SpiroSensePro software for use in professional environments: – SpiroSensePro – mySpiroSense Pro [see: Product variants, page 9] The following individual parts are included in the different variants: Basic components

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Devices for patients

2

Doctors' packages

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3

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Optional

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9

1

Measuring unit

2

Display unit

3

USB cable

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Batteries (2x)

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Nose clip

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Mouthpiece for home environments (reusable, 2x)

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Adapter

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USB stick with SpiroSensePro software

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Mouthpiece for professional environments (with bacterial filter, not reusable); 2 variants available

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–9– The following individual parts are included in all product variants: (1) Measuring unit (2) Display unit (3) USB cable The following parts may also be included in the pack depending on the product variant: (4)

(5)

(6)

(7)

(8)

mySpiroSense

×

×

×

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mySpiroSense Track

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Devices for patients

Doctors' packages1

2.2

SpiroSensePro

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×

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mySpiroSense Pro

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×

Product variants Devices for patients mySpiroSense: mySpiroSense is a mobile device for use by patients. Measurement data is stored in the device and can be read off directly from the device. Functions provided include the following: – A traffic light display for easy evaluation of measurement values – An electronic journal with automatic save function mySpiroSense Track: mySpiroSense Track is a device specially developed for use in studies, which can be used to transmit measurement results to a study centre as soon as a measurement has been completed. It can be coupled to a 2net hub manufactured by Qualcomm Life via a Bluetooth interface. After a measurement, the measurement results are then transferred to the hub automatically. The hub sends the data to a web portal on the internet. The web portal in turn makes the data available to the associated study centre mySpiroSense Track also offers the same functions as mySpiroSense.

Doctors' packages SpiroSensePro: This doctors' package consists of a device for doctors and the SpiroSensePro software. This package can be used to carry out spirometry measurements in the surgery. Spirometric data is captured in a real-time measurement, analysed by the software and displayed graphically.

1) The doctors' packages also include the instructions for use of the SpiroSensePro software.

– 10 – mySpiroSense Pro This doctors' package consists of a mySpiroSense device and the SpiroSensePro software. With the software, measurement data that was recorded for the patient using the mySpiroSense can be read and displayed.

2.3

Intended purpose The SpiroSense is a handheld spirometer for the measurement of human lung function parameters.

2.4

Intended use The mySpiroSense is a mobile device, allowing measurements of human’s lung function and lung function parameters. It can be used by medical professionals in clinical environment and by patients in the home environment. The mySpiroSense is intended for patient use in paediatric (3 to 17 years of age) and adult (18 to 95 years of age) patients. The patient himself will carry out the measurements – possibly with the support of a caregiver. Recorded data can be used by a medical professional for supporting diagnosis and disease monitoring purposes. The mySpiroSense can be connected to the SpiroSensePro software and the mySpiroSense software for more detailed measurement visualization and data presentation. The mySpiroSense Track is to be used in the same way as the mySpiroSense. Additionally the mySpiroSense Track can transfer data via Bluetooth. The SpiroSensePro is, in combination with the SpiroSensePro software, a device, allowing measurement and measurement analysis (diagnosis) of a human’s lung function. The SpiroSensePro data can be combined with the mySpiroSense data to support diagnosis and for therapy monitoring based on the electronic diary of the mySpiroSense. SpiroSensePro and the SpiroSensePro software are for the use of medical professionals in the medical field.

2.5

Indications The SpiroSense can be used in cases of/for: – Collecting parameters to evaluate lung function – Collecting lung function parameters to detect, exclude and observe the advance of diseases of the airways (e.g., bronchial asthma, COPD) – Assisting with treatment adjustment and treatment optimisation for diseases of the airways

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2.6

Contraindications The SpiroSense should not be used in cases of: – sudden/acute myocardial infarction – acute massive pulmonary embolism – pneumothorax – aneurysm – coughing blood – recent abdominal/chest surgery (the medical specialist must be consulted) – recent operations on the eyes/brain/ears (the medical specialist must be consulted) – hyperventilation syndrome

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2.8

Material information Polycarbonate

Display unit, measuring unit

Polyethylene

Adapter

Polypropylene

Housing for the reusable mouthpiece

Stainless steel

Metal screen in the reusable mouthpiece

Polystyrene

Housing of the mouthpiece with bacterial filter

Polypropylene

Filter membrane of the mouthpiece with bacterial filter

Operating life Component

Operating life

Display unit of the mySpiroSense

2 years

Display unit of the SpiroSensePro

5 years

Measuring unit

1 year 2

Adapter

1 year

Nose clip

2 years

Mouthpiece (for home environments)

365 measurements, max. 1 year

Mouthpiece with bacterial filter (for professional environments)

Single use

Batteries3

About 100 measurements and 50 Bluetooth transmissions

2) The calibration and measurement accuracy of the measurement unit guaranteed by PARI GmbH expires after 12 months of use, or at the latest on the “Use by" date (hourglass) indicated on the packaging. 3) This information relates to the supplied battery model. If another model is used (e.g., with different output or quality) the values may vary, in some cases significantly.

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2.9

Control elements The SpiroSense is equipped with the following control elements:

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On/Off button

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Port for USB cable

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Unlocking button

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3 control buttons:

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Top control button (forwards) Middle control button (activate / confirm) Bottom control button (back)

2.10 Lung function parameters Lung function parameters are calculated with the SpiroSense in accordance with the current standards of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).

Doctor's device (SpiroSensePro) The SpiroSensePro can determine the following lung function parameters: FEV1

Forced expiratory volume after 1 second

FVC

Forced vital capacity

PEF

Peak expiratory flow ("peak flow")

FEV1 / FVC

Relative capacity per second, Tiffeneau index

FEF75 (MEF25)

Forced expiratory flow at 75% of FVC

FEV0.5

Forced expiratory volume after 0.5 seconds

FEV0.75

Forced expiratory volume after 0.75 seconds

FEF25-75 (MFEF)

Average maximum expiratory flow rate between 25% and 75% of FVC

FEF50

Forced expiratory flow at 50% of FVC

FEV3

Forced expiratory volume after 3 seconds

FEV6

Forced expiratory volume after 6 seconds

FEF25 (MEF75)

Forced expiratory flow at 25% of vital capacity

– 13 – FET

Forced expiration time

FEV0.5 / FVC

Relative capacity per half second

FEV0.75 / FVC

Relative capacity per three-quarters of a second

FIVC

Forced inspiratory vital capacity

FIV1

Forced inspiratory volume after one second

FIV1 / FIVC

Relative inspiratory capacity after 1 second

PIF

Peak inspiratory flow

Devices for patients The mySpiroSense and the mySpiroSense Track together can determine the following lung function parameters: FEV1

Forced expiratory volume after 1 second

FVC

Forced vital capacity

PEF

Peak expiratory flow ("peak flow")

FEV1 / FVC

Relative capacity per second, Tiffeneau index

FEF75 (MEF25)

Forced expiratory flow at 75% of FVC

FEV0.5

Forced expiratory volume after 0.5 seconds

FEV0.75

Forced expiratory volume after 0.75 seconds

FEF25-75 (MFEF)

Average maximum expiratory flow rate between 25% and 75% of FVC

FEF50

Forced expiratory flow at 50% of FVC

2.11 Display symbols The SpiroSense display screen has three main display areas:

Info line Main display Traffic light area The Info line and the traffic light area are used only by the patients' devices to display information. The doctor's device (SpiroSensePro) only uses the Main display.

All devices The following display symbols may appear in the main display on all devices after being switched on: The device is connected to a PC via the USB interface. USB communication faulty. The measuring unit is not attached correctly to the display unit. [see: TROUBLESHOOTING, page 36]

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Devices for patients

my my Track

A lot more information is displayed on the display in patients' devices. All three areas of the display are used. Info line: The Info line is used to display information about the current status of the device. The following icons may be displayed depending on the product variant: The device is in Configuration mode. [see: Configuring the device, page 17] The device is in Journal mode. In Journal mode, the data and time of the measurement that has been retrieved appears in the Info line. The device is in Comment mode. Only available with mySpiroSense Track: Some measurements have not yet been transmitted. The device is coupled to another device via Bluetooth. Charge level display for the batteries (three levels)

Main display: Depending on the product variant and operating mode, the following icons may appear in the main display of the patient devices: After switching on The batteries are almost flat. They should be replaced with new ones as soon as possible. The batteries are flat, the device will switch itself off soon. No more measurements can be taken. The batteries must be replaced with new ones immediately. The system is being calibrated. Calibration has been completed successfully. Calibration failed. [see: TROUBLESHOOTING, page 36] Configuration mode Configuration mode will be activated. Factory settings can be restored for all values. Only available with mySpiroSense Track: The device is attempting to couple with the 2net hub. The device is coupled with a 2net hub. The device could not couple with the 2net hub. [see: TROUBLESHOOTING, page 36]

– 15 – Measuring mode The device is ready to take a measurement. The measurement was taken successfully and has been saved. The measurement was not taken successfully and has not been saved. [see: TROUBLESHOOTING, page 36] Only available with mySpiroSense Track: Data is being transferred to the 2net hub via the Bluetooth interface. Data transfer to the 2net hub failed. [see: TROUBLESHOOTING, page 36] Data was successfully transferred to the 2net hub. Comment mode Emergency medication has been taken. An inhalation session has been completed. Contact with pollen or house dust. Strenuous physical activity. Contact with household pet. Productive coughing. Journal mode Journal mode will be activated. At least one comment has been added to the measurement shown.

Traffic light area: Marker for traffic light measurement value

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3

APPLICATION

3.1

Preparing the device The device should be kept at an ambient temperature which is suitable for operation for at least 2 hours prior to use [see: Operation, page 39].

Home environment

my my Track

CAUTION Risk of infection in the case of a change in patients If the device is used for multiple patients, pathogens can be transferred. To avoid the risk of infection, follow the instructions below: • Clean and disinfect the device before every change in patients. • Only use the reusable mouthpieces in the home environment, and only for the same patient in each case. • In professional environments, only use the disposable mouthpieces, which are available as options [see: Professional environment, page 16]. Prepare the patient's device as follows before every measurement: • Insert the batteries [see: Changing batteries (patients' devices), page 29]. • Attach the two parts of the mouthpiece (they should click audibly into place). • Insert the mouthpiece in the measuring tube on the measuring unit.

The device must be configured before it is used for the first time [see: Configuring the device, page 17].

Professional environment

Pro

CAUTION Risk of infection in the case of a change in patients If the device is used for multiple patients, pathogens can be transferred. To avoid the risk of infection, follow the instructions below. • Only use the optionally available disposable mouthpieces together with an adapter.

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®

Pro

NOTICE Damage to the measuring tube If the adapter is pressed into the measuring tube too firmly, the measuring tube may break. The device will then be unusable. • When pushing the adapter into the measuring tube, leave a small space between the ring of the adapter and the measuring tube.

appro

x. 3 m

m

Assemble the individual parts of the doctor's device (SpiroSensePro) as follows: • Insert the adapter into the measuring tube on the measuring unit. • Attach a new mouthpiece with bacterial filter to the adapter.

3.2

Configuring the device All of the settings needed to take a measurement with the doctor's device (SpiroSensePro) are made using the SpiroSensePro software. This product variant cannot be configured manually. On all patients' devices, the date and time must be set before the device is used for the first time [see: Setting the date and time, page 18]. The traffic light display is configured in the doctor's surgery or by the sales partner. The mySpiroSense may also be configurable manually as an alternative [see: Configuring the traffic light display, page 19]. The mySpiroSense Track should be coupled to a 2net hub before it is used for the first time [see: Coupling the device to a 2net hub, page 21]. If necessary, the mySpiroSense can be reset to the factory settings [see: Restoring factory settings, page 21].

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Activating / exiting Configuration mode

my my Track

Configuration mode is activated automatically when the device is switched on at initial startup and after the batteries are changed. ► The device is switched off. • Press and hold the middle control button for about 3 seconds. a Configuration mode will be activated. The date and time will be displayed:

• Use the top and/or bottom control buttons to scroll to the settings that need to be changed. To change the settings, refer to the following sections. When all settings have been configured, the following display appears:

Configuration mode cannot be closed until this symbol appears on the display. • Press the middle control button briefly. a Configuration mode will close, configuration is complete.

Setting the date and time

my

► Configuration mode is activated, the setting for the date and time is displayed [see: Activating / exiting Configuration mode, page 18]:

my Track

• Press the middle control button briefly to activate Change mode. a The first parameter of the date that can be changed is highlighted.

– 19 – • Use the top and/or bottom control buttons to change the value of the highlighted parameter. • Save the value by briefly pressing the middle control button. a The next parameter of the date is highlighted. • Change all of the date and time parameters as described. Æ When all of the date and time parameters have been changed as necessary, the current entry is saved. An audible signal indicates that the value has been saved. Change mode is deactivated.

Configuring the traffic light display

my

The traffic light display should only be configured by a doctor or after consulting with a doctor. The traffic light display is used to make a visual evaluation of the measurement result for a given lung function parameter ("traffic light measurement value"). For this function, a lung function parameter is selected and an expected value for a specific patient for this parameter is stored in the device. The traffic light measurement value is compared with this expected value after each measurement. The traffic light measurement value is displayed in the main display area on the screen and a marker appears in the traffic light area. The position of the marker indicates whether the value achieved is in the positive (green), acceptable (amber) or critical (red) range. The "traffic light threshold values" determine when a value is determined as being in the green or red range. These are also stored in the device. The traffic light display will not be active until values for the display have been stored in the device. After the device is switched on, the following appears on the screen:

The values for the traffic light display can be entered in any of the following ways: – at the doctor's surgery by the doctor using the SpiroSensePro software – by the local sales partner with reference to a doctor's prescription4 – directly on the device, manually To prevent unsuitable values from being entered, the values should be configured in the doctor's surgery using the software. If this is not possible, the values agreed with the doctor can be stored in the device as follows:

4) Not possible in all countries.

– 20 – Enter expected value ► Configuration mode is activated, the setting for the expected value in the traffic light display is shown [see: Activating / exiting Configuration mode, page 18].

• Press the middle control button briefly to activate Change mode. a The lung function parameter is highlighted. • Use the top and/or bottom control buttons to select the desired lung function parameter. • Save the selection by briefly pressing the middle control button. a The value for the selected lung function parameter will be highlighted. • Use the top and/or bottom control buttons to set your personal expected value for the selected lung function parameter. The expected value is your personal target value. If this value is reached during a measurement, the marker will display 100%. • Save your entry by briefly pressing the middle control button. Define traffic light threshold values ► Configuration mode is activated, the setting for the traffic light threshold values is shown [see: Activating / exiting Configuration mode, page 18]:

• Press the middle control button briefly to activate Change mode. a The lower traffic light threshold value is highlighted. • Use the top and/or bottom control buttons to set the value beyond which the measurement value is in the critical range (in %, relative to the defined expected value). If a value falls below the lower threshold value when a measurement is taken, the marker in the display points to the red traffic light range. • Press the middle control button briefly. a The upper traffic light threshold value is highlighted. • Use the top and/or bottom control buttons to set the value beyond which the measurement value is in the positive range (in %, relative to the defined expected value). If a value reaches above the upper threshold value when a measurement is taken, the marker in the display points to the green traffic light range.

– 21 – Rules for the traffic light threshold values: – The lower (on the left) traffic light threshold value must be smaller than the upper value (on the right). – The difference between the two values must be at least 5 percentage points.

Coupling the device to a 2net hub

my Track

To enable the measurement results obtained with the mySpiroSense Track to be transmitted to a web portal, the device must be coupled to a 2net hub via the Bluetooth interface. To do this, proceed as follows: ► A configured 2net hub is located in the line of sight of the device. ► Configuration mode is activated, the setting for the Bluetooth interface is shown [see: Activating / exiting Configuration mode, page 18]:

• Press the middle control button briefly. a The device is attempting to couple with the 2net hub. Æ Coupling is confirmed by the following display:

Æ When the device has been coupled successfully, the active Bluetooth interface is shown by the corresponding symbol in the Info line. Æ After each measurement, the measurement results are transferred to the 2net hub automatically when the device is switched off.

Restoring factory settings

my

If the device is reset to the factory settings, all settings including all measurement data saved on the device (including the journal) will be deleted. Only the settings for the date and time will be kept. Proceed as follows to reset the device: ► Configuration mode is activated, the setting for Resetting is shown [see: Activating / exiting Configuration mode, page 18]: