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Summary of Contents for MIR Spirodoc
- Page 1 User Manual User Manual Rev. 4.5 Issued on: 03/09/2008 Approved on: 03/09/2008 spirodoc user manual code 980165 Rev 4.5 page 1 of 27...
- Page 2 In the event that your unit has a problem use the original packaging to return the unit to your distributor or to the manufacturer. MIR has a policy of constant product improvement, and the technology within our products is also in constant evolution, thus we reserve the right to update these instructions as necessary. We appreciate all suggestions from our users, please send emails to the following address: mir@spirometry.com.
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Page 3: Table Of Contents
Cleaning and general control of the turbine ....................19 Replacement tape instructions ........................19 Changing the battery ............................19 POSSIBLE PROBLEMS............................20 Causes and solutions ............................. 20 CONFIGURATION MANUAL FOR THE SPIRODOC....................21 Configuration menu ............................21 6.1.1 Select Language ........................21 6.1.2 Delete Test Data ........................ -
Page 4: Spirodoc User Manual Code
Intended use The spirodoc spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single patient device and can be used in any setting- home, factory, pharmacy, hospital or physician office. -
Page 5: Danger Of Cross-Contamination
If the patient cable appears damaged, do not use it. Contact your authorized repair centre for help. Use only MIR SpO2 sensors supplied with, or specifically intended for use with the spirodoc. Use of sensors not intended for use with the spirodoc may cause inaccurate readings. -
Page 6: The Instrument
IEC 60601-1-1 only equipment which complies to the current safety regulations may be used. For the recycling of the spirodoc, accessories, plastic consumable materials (mouthpieces) plus the battery, use only the appropriate containers or return all such parts to the seller of the instrument or to a recycling centre. All appropriate local regulations must be followed. -
Page 7: Ce Mark For Medical Devices
It makes a quality control check on the test carried out. spirodoc is intended for any doctor, from a family doctor to a specialist, requiring a small and compact instrument able to make full spirometry and oximetry tests. -
Page 8: Oximeter Sensor
Measured parameters: %SpO2 Oxygen Saturation Pulse Rate Beats Per Minutes (BPM) ♥ Pulse oximeter sensor: The sensors intended to use with Spirodoc are: • BCI 1300 Adult Disposable Sensor • BCI 3026 Neonatal Wrap Sensor • BCI 3043 Universal Y Sensor •... -
Page 9: Spirometric Normal Values
. These values are taken from a healthy population and are calculated from tables or formulas in function of the age, height and sex of the subject in question. spirodoc automatically calculates the relevant “ normal values ” and compares them as a percentage with the “measured values”. -
Page 10: Battery Level
If the battery is completely discharged the following message is shown on the display: LOW BATTERY WARNING If the "battery discharged" condition occurs during an oximetry test then spirodoc emits a constant beep (providing this function is switched on!) To make a test Switch on the spirodoc by pressing the "↵... -
Page 11: Entering Subject Data
The default threshold values are shown. If the optional oximetry module has not been purchased with the spirodoc then only spirometry testing can be carried out. -
Page 12: Making A Spirometry Test
In the event of a “mixed” interpretation (obstruction plus restriction), then the colour code always refers to the more severe of the two pathologies. spirodoc may show one of the following messages, showing the “test quality” of the test made: Next test spirodoc user manual code 980165 Rev 4.5... -
Page 13: Making A Spot Oxymetry Test
If the last expiratory flow measured is too high (> 0,2 L/s). After these test quality control messages have been shown (if generated) then the spirodoc shows the values of FVC, FEV1, FEV1%, PEF , 2575 and FET of the current test 4.82... -
Page 14: Making Long Term Oximetry Testing
The oximetry measurement can be stopped by pressing STOP. If SpO2 is selected spirodoc checks if the sensor is connected and if a finger is inserted into the sensor, and one of the following messages may be displayed:... -
Page 15: Making A Test
Press STOP within 2 seconds to return to the main menu, otherwise spirodoc will continue the long term measurement. TEST RESULTS spirodoc will memorise the details of the best spirometry test, selecting the test with the highest sum of FVC+FEV1 , plus the most recent oximetry test made on the current subject. -
Page 16: Viewing The Results
Is shown, this means that no tests have been made since the new subject data were entered. Print out of the results To print the results held in memory, connect the spirodoc to a parallel printer and press the " " key from the main menu. The results are then sent automatically to the printer. - Page 17 980165 Rev 4.5 page 17 of 27...
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Page 18: Print Out
3.3.1 Print out EXAMPLE OF RESULT PRINTOUT spirodoc user manual code 980165 Rev 4.5 page 18 of 27... -
Page 19: Maintenance
• Press firmly on sensor to push pegs through tape holes. Pick up both sensor and tape and verify sensor pegs are aligned properly. Changing the battery When ' ' BATTERY LOW' ' appears on the display of the spirodoc at switch on, or if the machine does not switch on at all, then change the operating battery. WARNING Only use 3V Lithium battery CR123A or equivalent. -
Page 20: Possible Problems
A list of possible problem follows plus a list of messages which may appear on the display to indicate the type of problem: Causes and solutions spirodoc does not switch on Check that the battery is inserted correctly inside the battery cover on the back of the machine. If it is then, change the battery. -
Page 21: Configuration Manual For The Spirodoc
• press “↵ ↵ ↵ ↵ ” to reinput the code, or " ∆ ∆ ∆ ∆ " and " ∇ ∇ ∇ ∇ " to exit. After two attempts with the wrong code the spirodoc switches off automatically, to avoid errors. -
Page 22: Date Format
6.1.8 Unit Format UNIT FORMAT • press Ok to select the measurement units required. Select either Kg,cm or Lb,in using the " " key. Press Ok to confirm. spirodoc user manual code 980165 Rev 4.5 page 22 of 27... -
Page 23: Select Printer
STORE ALL TEST • press Ok to modify the setting. Press the YELLOW key to select or deselect the function. The default setting of spirodoc will memorise only the best test from any session. spirodoc user manual code 980165 Rev 4.5... -
Page 24: Declaration Of Ec Conformity
Notified body CERMET N° 0476 - Certificate of Conformity N° MED – 9826 MIR srl Medical International Research declares that the Device subject of this declaration together with its standard accessories conforms to the requirements of the Council Directive 93/42/EEC Annex II point 3. -
Page 25: Limited Warranty Conditions
MIR. The instrument must be checked at the time of purchase and any claims must be made immediately in writing to MIR. This warranty covers the repair or the replacement (at the discretion of the manufacturer) of the product or of the defective parts without charge for the parts or for the labour All batteries and other consumable parts are specifically excluded from the terms of this guarantee. -
Page 26: Annex 1 Information For Correct Use In An Electromagnetic Environment
Guidance and manufacturer’s declaration – electromagnetic emissions The spirodoc is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirodoc should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... - Page 27 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the spirodoc is used exceeds the applicable RF compliance level above, the spirodoc should be observed to verify normal operation.
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Questions and answers
How can I change the **** of a patient after the test has been done
The provided context does not include specific instructions on modifying patient information after a test has been completed. However, it does mention a section on "Patient data modification," suggesting that it may be possible within the device settings. You may need to navigate the device menu to access and modify patient data.
This answer is automatically generated