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Respiro Operating Instructions
[Function/Subject]
[Document type]
Bittium Respiro™
Operating Instructions for healthcare
professionals
© Bittium Biosignals Ltd Pioneerinkatu 6 FI-70800 Kuopio Finland
www.bittium.com
Date of issue: Mar 27, 2025
D0000009279 Version 5.0.0

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  • Page 1 Respiro Operating Instructions [Function/Subject] [Document type] Bittium Respiro™ Operating Instructions for healthcare professionals Date of issue: Mar 27, 2025 © Bittium Biosignals Ltd Pioneerinkatu 6 FI-70800 Kuopio Finland D0000009279 Version 5.0.0 www.bittium.com...
  • Page 2 Bittium Biosignals Ltd shall not be liable for errors contained herein or for damages in connection with the furnishing, performance, or use of this material.
  • Page 3: Table Of Contents

    Respiro Carry case contents ......................18 Carry case packing ........................... 20 Configuration options ........................21 Equipment needed in recording ...................... 21 Respiro indicator LEDs and power button functions ............... 21 4.5.1 LED indications in idle state ......................21 4.5.2 LED indicators during recording ....................22 4.5.3...
  • Page 4 Other actions ..........................41 Maintenance ............................ 44 Cleaning and disinfection ........................ 44 Changing the Respiro Device Manager language ................45 Updating Respiro firmware and Respiro Device Manager software ..........45 IT network ............................48 Battery replacement ........................48 Troubleshooting ..........................49 Potential issues with the Respiro device ..................
  • Page 5 Appendix 1: Setting the device password ....................... 59 Manufacturer information ..........................61 D0000009279 Respiro Operating Instructions for healthcare professionals 5 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 6: Conventions

    1.1 Terminology Table 1 Terms used in the document Term Description Electrocardiogram European Data Format HSAT Home sleep apnea testing Ingress Protection Medical Device Regulation D0000009279 Respiro Operating Instructions for healthcare professionals 6 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 7: General Warnings And Cautions To Review Before Use

    WARNING: RIP belts must not be worn against skin. WARNING: Respiro is not intended to be used at the same time with high frequency (HF) surgical equipment or with a defibrillator. WARNING: Position the nasal cannula carefully. Use medical tape for securing the cannula.
  • Page 8 EMC disturbances may cause interference and/or noise to recording data. CAUTION: Respiro device should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, the device should be observed carefully to verify normal operation.
  • Page 9 Body-worn components (e.g. medical tape) may irritate skin, but there are no other known adverse events due to using the Respiro device. If the patient has lots of body hair it must be shaved from the area where the ECG electrode is attached (applicable only in ECG use case).
  • Page 10 NOTE The screenshots shown in the document may not represent the latest software User Inter- face views. D0000009279 Respiro Operating Instructions for healthcare professionals 10 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 11: Introduction

    The device is intended to be used as a screening device for brief overnight polygraphy, which is always carried out by doctor’s prescription. Use of Respiro for any other purpose is prohibited. Respiro is used either in a hospital or at patient’s home. The device records patient’s biosignals. The device does not actively monitor the patient’s status, make diagnoses or treat the patient and it cannot be used as a life-...
  • Page 12 BLE and USB: https://www.nonin.com/support/3150-ble/. Operator’s Manual can also be found from device’s memory. NOTE The screenshots shown in the document may not represent the latest software User Inter- face views. Table below lists the biosignals and sensors used in Bittium Respiro: Table 2 Signals and sensors Signal Sensor Airflow...
  • Page 13: Adverse Events

    System applications are recommended to be used with computers with proper anti-virus protection in- stalled. Use of firewall is also recommended. With any concern related to security please contact medi- cal.support@bittium.com for additional recommendation and support. D0000009279 Respiro Operating Instructions for healthcare professionals 13 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 14: Symbols And Labels

    15 cm and 1 m for 30 minutes. Ingress protection rating. Device is protected against small objects (≥2,5 mm) and IP31 condensation. Wireless Transmission Symbol. D0000009279 Respiro Operating Instructions for healthcare professionals 14 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 15 An atmospheric pressure range of 700 hPa to 1 060 hPa. Use-by date. Date of manufacture. Keep away from sunlight. D0000009279 Respiro Operating Instructions for healthcare professionals 15 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 16 Single patient multiple use. Serial number. D0000009279 Respiro Operating Instructions for healthcare professionals 16 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 17: User Responsibility And Warranty

    The use of medical device components or system parts other than those approved by the manufacturer may break the device, decrease its performance, or cause other issues. Shelf life of the medical device components and other system parts shipped with Respiro can be seen from the product packing markings.
  • Page 18: Using Respiro

    Pulse oximeter Nonin 3150 with batteries (type AAA), 2 pcs (inserted) RIP (Respiratory inductance plethysmography) belt(s) for attaching Respiro to body (applied part). Two sizes are available, short and long. • Size Short: Length approx. 80 cm, recommended range of use 80 - 120cm.
  • Page 19 Respiro patch for 2 RIP belts (Applied part), 2 pcs Respiro ECG Adapter (applied part, single use) Bittium OmegaSnap™ ECG electrode (applied part, single use) Bittium Respiro Quick Guide Bittium Respiro Notes and Warnings D0000009279 Respiro Operating Instructions for healthcare professionals 19 (63) Version 5.0.0...
  • Page 20: Carry Case Packing

    Make sure that the cannula length is optimal for each patient. Avoid using too long cannulas to ensure patient safety. 4.2 Carry case packing Figure below shows the Respiro carry case contents in HSAT™ recording. Figure 3 Carry case packing, HSAT D0000009279 Respiro Operating Instructions for healthcare professionals 20 (63) Version 5.0.0...
  • Page 21: Configuration Options

    4.3 Configuration options Respiro polygraphy recording can be carried out as an HSAT™ recording with three sensor configurations. Respiro device (integrated accelerometer and microphone), pulse oximeter with a finger sensor and nasal cannula are used in every setup options. Instead, the number of RIP belts and the inclusion of ECG (elec- trocardiography) electrode are dependent on the used setup option.
  • Page 22: Led Indicators During Recording

    5 minutes Respiro will shut down. In that state Respiro has no LED indications. 4.5.2 LED indicators during recording Respiro LED indicators show recording status as described in Table 4 during recording. For potential error situations refer to Chapter 6.
  • Page 23: Led Indicators While Charging Respiro

    4.5.3 LED indicators while charging Respiro Respiro LED indicators blink as described in Table 5 when Respiro is charged in its charging dock. Table 5 LED indicators during charging Color Meaning Leftmost LED blinking yellow: Battery charge 0-29 %. Leftmost LED blinking green: Battery charge 30-49 %.
  • Page 24: Before Recording

    Before performing Bittium HSAT recording, Respiro device is charged, and batteries are inserted to the pulse oximeter to check the battery state. Make sure that the Respiro device’s battery charge status is suf- ficient (at least two green LEDs are blinking successively according to Table 5 while charging. Note! If scheduled recording is used all three indicator LEDs must be blinking successively to ensure sufficient bat- tery charge for the recording) for the planned recording.
  • Page 25: Charging Respiro

    4.6.1 Charging Respiro Set Respiro in the charging dock while making sure that the charging dock is connected to the power sup- ply. Connect the charging dock only to the USB port of the supplied power supply. Do not con- nect it anywhere else for charging.
  • Page 26 Figure 8 Threading the long part Figure 9 Attached wristband, back view Figure 10 Attached wristband, front view D0000009279 Respiro Operating Instructions for healthcare professionals 26 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 27: Checking The Device Pairs

    Then, after the pulse oximeter is started, Respiro device’s left LED indicator will be green, if the finger is inserted in the sensor and yellow if it is not. Respiro is not connected to the pulse oximeter in question if the left LED indicator is red.
  • Page 28: Respiro Device Manager

    1. Connect the Respiro device’s charging dock to a computer with the USB cable. 2. Set Respiro in the charging dock. Respiro indicator LEDs will be blue for a moment until the charg- ing cycle begins and the LEDs blink green cycling from left to right.
  • Page 29 Double-click Respiro Device Manager folder. Figure 13 Opening Respiro Device Manager from the Respiro Device Manager folder c) Double-click Respiro Device Manager file. A desktop shortcut is created when using Respiro Device Manager for the first time. D0000009279 Respiro Operating Instructions for healthcare professionals 29 (63) Version 5.0.0...
  • Page 30 Figure 14 Opening Respiro Device Manager.exe 4. Wait for the application to detect Respiro. Make sure that Respiro is inserted in the charger dock and that the charger dock is connected to the computer. 5. After the home view is opened, the Respiro Device Manager installs a Bittium Root certificate to the PC.
  • Page 31: Connecting Respiro And The Pulse Oximeter

    Figure 16 Respiro Device Manager Home view 4.7.2 Connecting Respiro and the pulse oximeter Follow these instructions if you need to connect Respiro and the pulse oximeter again due to e.g. a device failure: 1. Open Respiro Device Manager as instructed in the earlier chapter 4.7.1.
  • Page 32 3. Start the pulse oximeter by pressing its power button (see chapter 4.6.3) with e.g. your fingernail when the application requests you to do so and click OK. Connecting starts. Figure 18 Pulse oximeter has connected to Respiro successfully! D0000009279 Respiro Operating Instructions for healthcare professionals 32 (63) Version 5.0.0...
  • Page 33: Hsat Recording Mode

    Respiro device, and this is why the connecting process fails. In this case enter the oximeter’s serial number in the Pulse oximeter device name field in the Respiro Device Manager home view and click Save. This replaces the old device pair with this new one.
  • Page 34: Starting Recording

    In HSAT recording it is possible to set the recording to start and stop at a predefined time in cases where the patient may not be able to start it by himself/herself. The function is activated in the Respiro Device Manager main screen.
  • Page 35 Figure 21 Respiro Device Manager home view Figure 22 Set the scheduled recording ON 1. Set the Scheduled recording On. 2. Select the starting time from the drop-down list. 3. Select the ending time from the drop-down list. 4. Click “Save”.
  • Page 36: Starting A Recording Manually

    When Bittium HSAT recording is performed with manual start and stop, the patient starts a recording man- ually by pressing the Respiro power button first shortly, approx.. 3 seconds, to wake up the device and then about 8 seconds press to start a recording. Starting a recording is indicated by a short vibration.
  • Page 37: During Recording

    Stopping of Bittium Respiro recording is indicated by vibration of three times and with blue LED lights (lit in blue one by one from left to right). Note that the blue (and stabile) Respiro LEDs are lit for 5 minutes after stopping, but the device can be detached from the body and packed to the carry case.
  • Page 38 3. Start Respiro Device Manager application. Wait for the application to detect Respiro. Respiro De- vice Manager home view opens. See chapter 4.7.1 for information on how to start the Respiro De- vice Manager application. 4. Select “Tools” from the top of the view.
  • Page 39 Figure 26 Save location selection After the files are saved erase the recording data from the recorder by clicking “OK” in the Information view. D0000009279 Respiro Operating Instructions for healthcare professionals 39 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 40 Those files that were not removed will then remain visible in the Save recording files view. Figure 28 Unremoved files 8. Click “Eject”. You can remove Respiro from the charging dock when the application instructs you to do so. D0000009279 Respiro Operating Instructions for healthcare professionals 40 (63) Version 5.0.0...
  • Page 41: Other Actions

    4.11.2 Other actions Remember to erase prior recording data from the Respiro device before preparing it for a new patient. See chapter 4.11.1. Charge the Respiro and replace the pulse oximeter batteries as required. Replace batteries to a pulse oxi- meter when it reaches less than three segments on the screen.
  • Page 42 6. Click on Reset and let the reset operation go through. Figure 31 Reset ongoing Do not remove Respiro from the charging dock while resetting the device. Respiro device functionality may malfunction and cause an error state that can only be repaired in a service facility.
  • Page 43 Figure 32 Reset was successful NOTE If you have set a password for the device, the "Reset Recorder" function will also erase the set password. D0000009279 Respiro Operating Instructions for healthcare professionals 43 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 44: Maintenance

    You must ensure that the operating system in the computer you are using is up-to-date and secure. 5.1 Cleaning and disinfection Respiro, pulse oximeter, wristband, Respiro patches, charger dock as well as the carry case, laminated Quick Guide and laminated Notes and Warnings must all be cleaned and disinfected before first use and also after every recording.
  • Page 45: Changing The Respiro Device Manager Language

    Tools page: 1. Connect the charging dock to a computer with the USB cable. 2. Set the Respiro device in the charging dock. Ensure that the device rests properly in the charging dock. 3. Start Respiro Device Manager application (see Chapter 4.7.1). Wait for the application to detect the Respiro device.
  • Page 46 7. If new updates are available, a confirmation window is shown: Figure 34 Update available Updates can be installed later by pressing “Remind me later”. The Respiro Device Manager informs about available update next time it is opened again. 8. Press “Install updates”. A window with a progress bar is shown to indicate the progress of the up- date process.
  • Page 47 Updating can be tried again, but if the problem persists, please contact Bittium. 9. After installation, the new versions are shown briefly and then the Respiro Device Manager restarts automatically: Figure 36 Latest updates have been installed 10.
  • Page 48: Network

    5.5 Battery replacement Respiro device battery is an in-built part of the device and can be changed only by Bittium Biosignals Ltd. Battery lifetime depends on device usage modes and recharging cycles. It is recommended to replace the battery after max. 2 years. Scheduled maintenance of the device is performed every 2 years. The battery is replaced during scheduled maintenance.
  • Page 49: Troubleshooting

    • Respiro has red light(s) on: o If some of the Respiro device’s indicator LEDs is red see Table 7, Table 8 and Table 9 below. Table 7 Respiro common LED indications in error states Color Meaning All LEDs flash red once: Failed recording start.
  • Page 50 If some of the LEDs are green, the sensor in question is ok. Table 9 Respiro 4 sensor configuration LED indications in error states 4 sensor configuration (2 RIP belts with ECG), 2 LEDs on for 1 second cycling from...
  • Page 51: Potential Issues With Respiro Device Manager

    If pulse oximeter still does not start, replace batteries. • Computer does not detect Respiro when Respiro is in the charging dock and the charging dock is connected to the computer: Check the charging dock connection to the computer and that Respiro is properly set in the charging dock.
  • Page 52: Reset Error

    General error – An error occurred while installing updates: close the program and try to install the updates again. Update error – The recorder of the Respiro Device Manager could not be updated. If the problem persists, please contact your service provider.
  • Page 53: Product Safety And Regulatory Information

    Certificate of Conformity and Declaration of Conformity in accordance with the applicable directives and standards can be requested from bbs@bittium.com 7.2 EMC This product meets the requirements of the electromagnetic compatibility (EMC) standard EN 60601-1-2. D0000009279 Respiro Operating Instructions for healthcare professionals 53 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 54: Technical Information

    Battery charging: Battery manufacturers restrict charging the battery above the defined battery tempera- ture limit to avoid overheating the battery and to ensure safe user experience in all conditions. As the device manufacturer, Bittium recommends ensuring that Respiro charging environment temperature is max.+30°C to enable smooth and uninterrupted battery charging.
  • Page 55: Respiro Specifications

    * Pulse oximeter’s PPG sampling rate is 75 Hz. SpO2 value is calculated based on PPG signal once per sec- ond (1Hz). This is a reasonable sampling rate due to the nature of the particular biosignal (slowly variable parameter) D0000009279 Respiro Operating Instructions for healthcare professionals 55 (63) Version 5.0.0...
  • Page 56: Magnet Specification

    8.6 Electromagnetic emissions Table 12 Electromagnetic emissions Manufacturer’s declaration - Electromagnetic emissions Respiro is suitable for use in an electromagnetic environment as described below. The users should ensure that the device is used in such an environment. Emission test Compliance...
  • Page 57 (MHz) power (V/m) (MHz) 380-390 TETRA 400 Pulse modulation 18 Hz 430-470 GMRS 460, FRS 460 ± 5 kHz deviation 1 kHz sine D0000009279 Respiro Operating Instructions for healthcare professionals 57 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 58 2400-2570 Bluetooth, Pulse modulation WLAN, 217 Hz 802.11 b/g/n, RFID 2450, LTE Band 7 5240 5100-5800 WLAN 802.11 Pulse modulation 217 Hz 5500 5785 D0000009279 Respiro Operating Instructions for healthcare professionals 58 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 59 APPENDIX 1: SETTING THE DEVICE PASSWORD Follow these instructions to set a device password for Respiro. It is not mandatory to set this password, so use this function only if it is absolutely required. Note that the password is device-specific, so keep track of these passwords! Before you start: Copy the Respiro Device Manager folder e.g.
  • Page 60 8. Close the DEVICE.CFG file. 9. Eject Respiro by using the Safely Remove Hardware and Eject Media-function. Note that after the password is set Respiro must be powered off and restarted to make the change effective (12 second press to power off device).
  • Page 61: Manufacturer Information

    Finland evismo AG Schweighofstrasse 409 8055 Zürich Switzerland OmegaSnap™ Bittium Biosignals Ltd Pioneerinkatu 6 70800 Kuopio Finland evismo AG Schweighofstrasse 409 8055 Zürich Switzerland D0000009279 Respiro Operating Instructions for healthcare professionals 61 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 62 EU Importer for 70800 Kuopio Finland CNSAC Nasal Pressure monitoring cannula CNSAC MedShop GmbH Am Sonnenstuhl 63 97236 Randersacker Germany Somnovum Industriestrasse 14 CH-5036 Oberentfelden D0000009279 Respiro Operating Instructions for healthcare professionals 62 (63) Version 5.0.0 © Bittium Biosignals Ltd 2025...
  • Page 63: D0000009279 Respiro Operating Instructions For Healthcare Professionals

    WEBSITE You can find up-to-date product information, documents, and updates by visiting the Bittium website at www.bittium.com SALES Please contact your sales representative for any questions that you may have about Bittium products. Bittium Biosignals Ltd. Tel.: +358 40 344 2000 Pioneerinkatu 6 Email: bbs@bittium.com...

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