Related Manuals for Restech RT1105
Summary of Contents for Restech RT1105
- Page 1 Instructions for use (Ref: RT1105) Revision 04 – February 2024 Software version: 1.1.x...
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Page 2: Table Of Contents
FIRST - INSTRUCTIONS FOR USE CONTENTS Introduction Clinical information Descriptive information Instructions for your safety General precautions Turn on / off the device and the home screen Change device settings Navigate the internal archive Perform a new measurement 10. Charging the device 11. -
Page 3: Introduction
“Intended Use”. Complications RESTECH is not aware of any complications due to the device used under its intended use. Undesirable side effects RESTECH is not aware of any undesirable side effects due to the device used under its... -
Page 4: Descriptive Information
FIRST - INSTRUCTIONS FOR USE 3. Descriptive information Description of the device FIRST is a medical device designed for assessing mechanical impedance through the use of the Forced Oscillation Technique, also known as Oscillometry. Oscillometry is a non-in- vasive approach to measuring the mechanical properties of the respiratory system. During the measurement, small pressure oscillations are applied to the respiratory system to elic- it an oscillatory flow in and out of the lungs to allow the measurement of respiratory im- pedance (Zrs). -
Page 5: Instructions For Your Safety
If any accessories are damaged or lost, please contact your local distributor. CAUTION! RESTECH recommends paying particular attention to the subject’s positioning during the measurement to ensure that the upper airways are not obstructed, either partially or entirely, by the tongue or teeth. -
Page 6: General Precautions
FIRST - INSTRUCTIONS FOR USE 5. General precautions CAUTION! Failure to observe the precautions listed below may cause risks for the subject, for the user, or the loss of integrity of the device. – Handle with care. Rough handling or misuse could cause hardware and electrical damage. –... -
Page 7: Navigate The Internal Archive
– Make a calibration check. – Enable or disable the head position check. – Visualize the device information: 1) device serial number, 2) current date and time, 3) firmware version, 4) calibration ID and 5) language pack loaded onto the device. –... - Page 8 FIRST - INSTRUCTIONS FOR USE Total number of oscillometry measurements performed, up to a maximum of five per each session; the ones used for calculating the mean results are marked with a green tick, those discarded with a red cross. Quality control parameters of the measurement session (inter-measurement coefficient of variation (CoV) of the selected measurements (green tick) and mean ventilation (Ve) are reported in this screen.
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Page 9: Perform A New Measurement
CAUTION! The device can visualize a maximum of 15 measurement sessions; new sessions are visualized on a first-in-first-out basis, thus the oldest sessions are progressively replaced by the newest ones. For each session, the subject’s age, sex, height, weight and, optionally, custom ID are saved, hence they can be considered pseudo-anonymized. - Page 10 FIRST - INSTRUCTIONS FOR USE Once the finger is properly positioned, the pulse oximetry measurement will initiate automatically, and within a few seconds, the display will present the initial readings for oxygen saturation (SpO , in %) and heart rate (PR, in beats per minute).
- Page 11 Oscillometry measurement NOTE: Oscillometry measurements must be performed with the subject in sitting position. Insert the subject age and sex, by pressing the correspondent buttons on the display. Press the Next button on the right to confirm the data. Then, insert the height and weight by pressing the correspondent buttons on the display.
- Page 12 FIRST - INSTRUCTIONS FOR USE 4. Ask the subject to use their hand to support their cheeks. 5. Position the subject’s head slightly upward. Start button on the right and instruct 6. Initiate the measurement by pressing the the subject to breathe normally into the device. 7.
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Page 13: Charging The Device
11. Exporting, saving and printing the measurement results You can export and save the results of the measurements obtained with the FIRST device to your PC through the desktop software. Register your product on www.restech.it to download your copy of the software. - Page 14 FIRST - INSTRUCTIONS FOR USE Upon startup, insert the device password (see section “Change device settings”) to access the list of stored measurements on the FIRST device (up to 200 sessions). Values for Rrs and Xrs that fall outside the normal range will be displayed with a red background. Additionally, any CoV of Rrs exceeding the recommended threshold (10% for adults and 15% for children) will also be highlighted in red.
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Page 15: How To Disassemble And Reassemble The Device
12. How to disassemble and reassemble the device To disassemble the device, detach the breathing circuit by first disconnecting the flap from the rear side of the device (1) and then from the frontal side (2). Detach the fan by pulling it from the motor shaft To reassemble the device, repeat the previous steps in the opposite order, paying attention to keep the fan parallel to the main body while reinserting it into the motor shaft. - Page 16 FIRST - INSTRUCTIONS FOR USE CAUTION! The use of a bacterial/viral filters reduces the contamination of the parts behind it. However, a thorough cleaning and disinfection of the device still has to be performed CAUTION! During the cleaning and disinfection process for the device, employ gloves that are legally approved and of the suitable type and length.
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Page 17: List Of The Units Of Measurement
Extraordinary Disinfection Procedure 1. Disassemble the breathing circuit and the fan from the main body of the device (see section “How to disassemble and reassemble the device”). 2. Clean all parts and components of the device with a soft cloth moistened with distilled water. -
Page 18: Symbols And Abbreviations
MADE IN ITALY MADE IN ITALY MADE IN ITALY FIRST FIRST FIRST (01) 0 8050612 84000 8 (01) 0 8050612 84000 8 (01) 0 8050612 84000 8 RT1105 RT1105 RT1105 (21) 2305EA006 (21) 2305EA007 (21) 2305EA008 (11) 231205 (11) 231205 (11) 231205... -
Page 19: Descriptive Information
ABBREVIATIONS Coefficient of variation Pulse rate Rrs insp Mean inspiratory resistance Rrs exp Mean expiratory resistance Rrs or Rrs tot Mean resistance of the whole breath %SpO Peripheral capillary oxygen saturation percentage Ventilation Xrs insp Mean inspiratory reactance Xrs exp Mean expiratory reactance Xrs or Xrs tot Mean reactance of the whole breath... -
Page 20: How To Return A Defective Device
17. How to return a defective device If you need to send your device back to RESTECH, follow these guidelines to ensure the safety of both yourself and our employees who will be handling it, and to facilitate a com- prehensive inspection of all its components. -
Page 21: Electromagnetic Compatibility
19. Electromagnetic compatibility The FIRST device complies with the IEC 60601-1-2:2014+AMD1:2020 standard (immu- nity and emissions). Further information on the accordance with the standard is available on request contact- ing the manufacturer, see section “User information”. The compliance with the above standard guarantees the safety of the device but special attention should be paid in the following situations: WARNING! Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. - Page 22 FIRST - INSTRUCTIONS FOR USE 1. Charge the device, see section “Charging the device” The device does not start up 2. Get in touch with your local distributor (refer to “User information” section) if the issue persists The device is not measuring the expected value of the Test Object.
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Page 23: Technical Specifications
21. Technical specifications Type Pressure drop across a resistive element; pressure measurement by mass flow principle Flow Range ± 1.5L/s measurement Linearity < ± 1 %FS in the range ± 1.5L/s Range ± 1.5 kPa Linearity ≤ ± 1.5 %FS in the range ± 0.5 kPa Mouth pressure Resolution 0.046 kPa... - Page 24 FIRST - INSTRUCTIONS FOR USE Power supply: • wall adapter (for recharging the internal battery only) Electrical 100-240 V, 50/60 HZ, 10 W input AC/ 5VDC 2A output specifications • Internal battery: rechargeable 7.2 V, 3.35 Ah, Li+ battery • Device in stand-by: ≥1 month Expected •...
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Page 25: User Information
RESTECH Srl is prohibited. Other product and company names included in these instructions are trademarks of those companies. RESTECH Srl has a policy of continuous development. RESTECH Srl reserves the right to make changes to this document without notice. - Page 26 FIRST - INSTRUCTIONS FOR USE Via M. Gioia 61/63 20124 Milan, Italy 0051 support@restech.it www.restech.it...
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