Sibelmed DATOSPIR TOUCH User Manual
Spirometer, pulse oximetry option module
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Also See for DATOSPIR TOUCH:
- User manual (76 pages) ,
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- User manual (20 pages)
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Summary of Contents for Sibelmed DATOSPIR TOUCH
- Page 1 DATOSPIR TOUCH SPIROMETER Pulse Oximetry option Module USER’S MANUAL 511-BE0-MU2 • REV. 1.05 • 2017-04...
- Page 2 SIBEL S.A.U., Rosellón 500 bajos 08026 BARCELONA (Spain) National Sales: Tel. 93 436 00 08 e-mail: comercial@sibelmed.com International Sales: Tel. +34 93 436 00 07 e-mail: export@sibelmed.com Technical service: Tel. +34 93 433 54 50 e-mail: sat@sibelmed.com Fax: +34 93 436 16 11, Website: www.sibelmed.com...
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Page 3: Table Of Contents
Pulse oximetry module user’s manual TABLE OF CONTENTS 1. SAFETY ………………………………………………………. 2. INSTRUCTIONS FOR USE AND INSTALLATION … 2.1. INTRODUCTION 2.2. PULSE OXIMETRY SETUP 2.3. PULSE OXIMETRY TEST PROCEDURE 2.4. PULSE OXIMETRY AND SPIROMETRY MEASUREMENTS 3. TECHNICAL SPECIFICATIONS ………………………. 3.1. TESTS, FUNCTIONS AND PARAMETERS 3.2. -
Page 4: Safety
Pulse oximetry module user’s manual SAFETY The pulse oximeter is a DATOSPIR TOUCH accessory and as such must meet the requirements set forth in the SAFETY section of this spirometer (see the general manual DATOSPIR TOUCH spirometer). INTENDED USE See the general manual DATOSPIR TOUCH spirometer... - Page 5 Pulse oximetry module user’s manual Reaction to the sensors by patients may be different depending on their health state and skin condition. No adhesive material should be used if the patient shows an allergic reaction to it. Tape applied too tightly may cause inaccurate readings and blisters on the patient’s skin.
- Page 6 Pulse oximetry module user’s manual Any condition that restricts blood flow (such as use of blood pressure cuff) may cause an inability to determine accurate pulse rate and SpO2 readings. The pulse oximetry sensor is CE marked and cannot reach temperatures >41 °C.
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Page 7: Instructions For Use And Installation
INSTRUCTIONS FOR USE AND INSTALLATION 2.1. INTRODUCTION The DATOSPIR TOUCH can incorporate a dedicated electronic board to take samples of oxygen saturation and heart rate. This board is fed to the main board and communicates with it through a specific serial port. - Page 8 Pulse oximetry module user’s manual can carry out specific measures of functional oxygen saturation (SpO ) and pulse rate (BPM) or during long-term studies (8 hours approx.), for patient control or sleep monitoring. In long-term studies, you can display the Trends (evolution of and BPM signal versus time) to calculate the parameters associated to the trends, print them or/and save them in the internal database.
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Page 9: Pulse Oximetry Setup
Pulse oximetry module user’s manual 2.2. PULSE OXIMETRY SETUP Start up the spirometer, access the pulse oximetry setup menu, by pressing and finally Then, the following screen will appear: Customize the pulse oximetry parameters according to your needs The average SpO (between 4 and 16 samples). -
Page 10: Pulse Oximetry Test Procedure
2.3. PULSE OXIMETRY TEST PROCEDURE 2.3.1. START UP If you have purchased the DATOSPIR TOUCH with the pulse oximetry module, it will be ready to use. If you have acquired the module later, you have to install the module in the device. - Page 11 Pulse oximetry module user’s manual 6 pins 5 pins Place the protective cover over the printer. Thus, the spirometer will be protected against splashing water (IPX2) during the pulse oximetry test, as described in standard EN ISO 80601-2-61:2011. Remember to place the protective cover against splashes of water whenever you perform pulse oximetry tests.
- Page 12 Pulse oximetry module user’s manual Use only the oximetry sensor supplied for the DATOSPIR TOUCH spirometer manufacturer. If you use non-validated sensors with this equipment, that may cause significant measurement errors. Select a suitable site for the sensor. The first finger (index) is the preferred location.
- Page 13 Pulse oximetry module user’s manual Incorrect use or inappropriate handling of the sensors can cause damage to the sensor or cable. This would lead to incorrect measurements and readings. To obtain the best results, especially during long-term studies (8 hours approx.); fasten the cable separately from the sensor, using surgical tape;...
- Page 14 Pulse oximetry module user’s manual 2.3.3. PERFORMING PULSE OXIMETRY TESTS On accessing this screen, the pulse oximeter automatically begins to acquire samples. The Oxygen Saturation (SpO ), Pulse Rate (BPM) values are displayed and the corresponding peripheral pulse wave. The wave’s registration lasts 5 seconds on the screen.
- Page 15 Pulse oximetry module user’s manual During a long term study, keep the pulse oximeter probe connected to the device. If you try to initiate a different function with an SpO2 test not saved, the device will show "IF YOU CONTINUE YOU WILL LOOSE SpO2 TEST PERFORMED! ARE YOU SURE? If the mains power is interrupted, for a period longer than 30 seconds, patient data is not lost.
- Page 16 Pulse oximetry module user’s manual A) SPECIFIC TESTS In specific pulse oximetry studies, the screen will indicate the and BPM values according to the average configured. In order to print the results, you must first save the signal (by pressing ) during the period required and then follow the instructions given in sections 2.3.5...
- Page 17 Pulse oximetry module user’s manual To display the signal saved, and calculate the parameters, access to the trends screen (by pressing If the finger clip is disconnected, the periods in which the SpO and BPM value is 0 will not be taken into account when calculating the parameters and the length of the test.
- Page 18 Pulse oximetry module user’s manual 2.3.5. DISPLAYING TRENDS Only if the study has been previously recorded ( ), trends can be shown by pressing Exits this screen and goes back to the previous Goes to a specific page (signal fragment) NORMAL mode: Goes back or forwards one page SEARCH mode:...
- Page 19 Pulse oximetry module user’s manual Calculates displays value parameters The trends screen displays the fragment of the SpO and BPM signal according to the screen time selected. The top left shows the relative time at the start of the study (hh:mm:ss).
- Page 20 Pulse oximetry module user’s manual previous) point where the SpO signal exceeds the reference value. 2.3.6. PRINTING AND/OR SAVING THE DATABASE The parameters are calculated upon accessing this screen. This option may take a few seconds, depending on the length of the study.
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Page 21: Measurements
Pulse oximetry module user’s manual Once a test has been saved on the Database (by pressing it can be retrieved in the same manner as any spirometric test. To obtain a report on the study performed, press If the device is still recording and you generate a report, the device will show "SAVING WILL STOP, DO YOU WANT TO CONTINUE?"... -
Page 22: Tests, Functions And Parameters
Pulse oximetry module user’s manual TECHNICAL SPECIFICATIONS 3.1. TESTS, FUNCTIONS AND PARAMETERS The parameters calculated to display, print or save on the Database are as follows: CT90 % of time in which SpO is below 90% CT80 % of time in which SpO is below 80% ... -
Page 23: Measurements And Ranges
Pulse oximetry module user’s manual 3.2. MEASUREMENTS AND RANGES Pulse (BPM -1/min) Measurement Range 0-100 30-235 Resolution Accuracy: ±2 (81 to 100%) ±2 bpm (30 to 100 /min) ±3 (70 to 80%) ±2% (101 to 235 /min) Undefined(<70%) Plethysmogram 0-100 Auto-gained for highest resolution Update rate: 1Hz Signal quality indicator:... -
Page 24: Preventive Maintenance
A second type consists of a general technical verification of security systems, settings, features, etc. that make up the Pulse oximetry module. This Technical check will be performed according to the DATOSPIR TOUCH’s Pulse oximetry module Verification and Adjustment Procedure, available... -
Page 25: Corrective Maintenance
Pulse oximetry module user’s manual On all accounts, SIBEL S.A.U., as the manufacturer, must provide written authorization, for at least the guarantee period, for the corresponding technical personnel to carry out said maintenance and will not be held liable under any circumstances for any damage, malfunction, etc.
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