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BITTIUM RESPIRO™ NOTES AND WARNINGS
Do not operate Bittium Respiro™ device without first reviewing the following notices.
WARNING:
trode or cannula for which the packing has been damaged or opened. Contact
nursing staff if the devices and sensors are damaged.
WARNING:
single-use only. Reuse be-tween patients is strictly prohibited. The reuse of
single-use products may lead to contamination.
WARNING:
WARNING:
quency (HF) surgical equipment or with a defibrillator.
WARNING:
the cannula. Make sure that the cannula length is optimal for each patient.
Avoid using too long cannulas to ensure patient safety.
WARNING:
WARNING:
not use fluids or chemical cleaning agents for cleaning. Disconnect power sup-
ply before cleaning.
CAUTION:
produce excessive pressure to nasal cannula's pressure hose.
CAUTION:
facturer when cleaning and disinfecting the devices. Immersing the devices in
liquids is prohibited.
CAUTION:
they interfere with the pulse oximeter.
D0000011975 Respiro Notes and Warnings
Version: 5.0.0, Date of issue: Mar 27, 2025
Do not use a broken device or a RIP belt, ECG adapter, ECG elec-
Nasal cannula, ECG adapter, ECG electrodes and RIP belts are for
RIP belts must not be worn against skin.
Respiro is not intended to be used at the same time with high fre-
Position the nasal cannula carefully. Use medical tape for securing
Do not open and/or modify the equipment.
Risk of lethal electric shock if fluid leaks into the power supply. Do
Respiro device's internal pressure sensor is very sensitive. Do not
Use only mild detergents and disinfectants approved by the manu-
Nail polish and artificial nails must be removed before recording as
© Bittium Biosignals 2025
1 (6)

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Summary of Contents for Bittium RESPIRO

  • Page 1 WARNING: RIP belts must not be worn against skin. WARNING: Respiro is not intended to be used at the same time with high fre- quency (HF) surgical equipment or with a defibrillator. WARNING: Position the nasal cannula carefully. Use medical tape for securing the cannula.
  • Page 2 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Respiro device, including cables specified by Bit- tium Biosignals Ltd. Otherwise, degradation of the performance of this equip- ment could result.
  • Page 3 Use of Respiro for any other pur- pose 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-sustaining device.
  • Page 4 2017/745 regarding medical devices. Swiss authorized representative. Authorized representative in the European Community/European Union. Type BF applied part (electrically isolated). Do not re-use. D0000011975 Respiro Notes and Warnings 4 (6) Version: 5.0.0, Date of issue: Mar 27, 2025 © Bittium Biosignals 2025...
  • Page 5 The data to be encoded can be text or numeric data. GS1 data matrix includes GTIN and production identifier (PI). D0000011975 Respiro Notes and Warnings 5 (6) Version: 5.0.0, Date of issue: Mar 27, 2025...
  • Page 6 Schweighofstrasse 409 8055 Zürich Switzerland WEBSITE You can find up-to-date product information, documents, and updates by visiting the Bittium website at www.bittium.com D0000011975 Respiro Notes and Warnings 6 (6) Version: 5.0.0, Date of issue: Mar 27, 2025 © Bittium Biosignals 2025...