Related Manuals for MIR Spirotel
Summary of Contents for MIR Spirotel
- Page 1 Spirotel ® User Guide Spirotel ® User manual Rev. 1.6 Date issued 19.10.2020 Date of approval 19.10.2020 Page 1 of 37 Rev.1.6...
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Page 2: Table Of Contents
Technical specifications .....................................11 1.7.1 Spirometer specifications ..................................12 1.7.2 Oximeter specifications ..................................12 1.7.3 Oximetry alarms description ................................13 1.7.4 Other features ......................................14 USING THE Spirotel ® ......................................15 Display...........................................15 Turning the Spirotel ON and OFF ...............................16 ® Saving energy .......................................16 Main screen ........................................16 Symbols and icons .......................................16... - Page 3 Thank you. MIR does not accept any responsibility for any harm or damage caused by users failing to follow the instructions or failing to heed the warnings in this manual.
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Page 4: Introduction
INTRODUCTION Intended use The Spirotel® spirometer and pulse oximeter is intended to be used by a physician, by a licensed healthcare professional or by a patient under the instruction of a physician or of a licensed healthcare professional. The device is intended to test lung function and can make: •... -
Page 5: Important Safety Warnings
The product must not be used if malfunctions or faults are detected or suspected as these may compromise results. WARNING When the Spirotel device is used as an oximeter with limited alarms setting, the SpO and Pulse Rate shown on the display ®... -
Page 6: Mouthpiece
Reusable hard finger sensor (adults) 919020 These sensors, with the exception of the sensor MIR code 919020 which has the MIR connector with orange arrow, require the use of an extension cable for connection with the Spirotel . Two lengths of extension cable are available: ®... -
Page 7: Usb Connection Cable
(e.g. the battery) only use suitable containers or better, send the materials to the device retailer or an approved disposal centre. Local current legal requirements must be complied with in all cases. Failure to comply with the above mentioned regulations will relieve MIR of all responsibility from any direct or indirect claim for damages. - Page 8 Spirotel ® User Guide Do not use or store the battery near a fire or in a car where the temperature can reach over 60°C. Do not immerse the battery in water or seawater and do not leave it wet. In the event of the battery getting wet, the internal protective device could be damaged leading to a recharge at very high voltages and currents.
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Page 9: Warnings Regarding The Gsm Module
Spirotel ® User Guide The battery has a predetermined life span. If the device appears to run for a shorter period of time than usual, replace the battery with a new one. Remove the battery if it is past its expiry date. -
Page 10: Fcc Certification Label
Spirotel ® User Guide SYMBOL DESCRIPTION Reference to US FDA regulations: use the device on prescription Rx ONLY Instruction for use symbol. Refer to instruction manual. Read this manual carefully before using the medical device Production date of the device USB port warning label. -
Page 11: Product Description
(optional). The device can operate completely ® autonomously or can be connected to a personal computer or printer by means of various types of connections: USB or Bluetooth. Also, Spirotel is connected to a PC via a micro USB port to recharge the battery. ®... -
Page 12: Spirometer Specifications
Spirotel ® User Guide Below is a complete description of the specifications for the device, the volume and flow turbine and the oximetry sensor. 1.7.1 Spirometer specifications This device meets the requirements of the following standard: • ATS Standardization of Spirometry 2005, 2019 update •... -
Page 13: Oximetry Alarms Description
Oximetry alarms description Spirotel is equipped with audio and visual alarm indicators to alert the operator to provide prompt patient attention or to abnormal device conditions. Spirotel detects both patient and equipment alarms. Both, patient alarms and equipment alarms are identified as medium priority as defined in IEC 60601-1-8 standard. -
Page 14: Other Features
Spirotel ® User Guide - Finger inserted incorrectly - Battery level is insufficient Visual Alarm Indicator When the alarm is activated through over limitation of physiological alarm, corresponding data area will view in reverse (video) mode. When the alarm is activated by more than one physiological alarm condition, each parameter will be displayed in reverse mode. -
Page 15: Using The Spirotel
MIR will make available on request wiring diagrams, parts lists, descriptions, calibration instructions or other information that will assist the service personnel in repairing those parts of the device which are designated by MIR as serviceable by the service personnel. -
Page 16: Turning The Spirotel ® On And Off
Spirotel ® User Guide Turning the Spirotel ON and OFF ® To turn Spirotel ON, press then release the key on the bottom of the unit ® When the device is turned on, the screen shows the manufacturer's name as well as the time and date. -
Page 17: Service Menu
Spirotel ® User Guide ICON DESCRIPTION To access oximetry area To access spirometry area To access the diary area To display the last test performed on current patient/display values from a test To send data to a phone by e-mail... - Page 18 Pairing: lets you automatically connect with a device in such a way that the spirometer acts as a “slave” device. Search devices: to look for devices that are available for connection. The Spirotel will start searching for nearby Bluetooth devices;...
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Page 19: Configuration Menu
Spirotel ® User Guide To exit the service menu, press OK at the bottom right of the screen. 2.6.1 Configuration menu On opening this menu, the following headings will appear: • Turn ON mode • Patient data • Oximetry setup •... - Page 20 Spirotel ® User Guide If you select automatic mode, the following options will appear: • Once time only • Once a week • Monday to Friday • Saturday – Sunday • Every day a menu will appear for each option that lets you set the time and day parameters for...
- Page 21 Spirotel ® User Guide In case of ATS/ERS standards: depending on the ethnic group set, the correction percentage acts on the theoretical values of the following parameters: FVC, FEV1, FEV3, FEV6, VC In the case of NHANES III standards: depending on the ethnic group set: different theoretical formulae are taken into account (in accordance with the reference standard).
- Page 22 Spirotel ® User Guide Default alarms (factory setting) This function allows to restore all factory default alarms setting. To confirm touch the “YES” icon. The settings return to the factory values. The image on the right shows the factory default alarms setting.
- Page 23 Spirotel ® User Guide Each of the test values can be checked with either a personal value set by the doctor or with a theoretical value by selecting one of the following headings: • Personal value • Theoretical value Select predicted Touch the display to select the heading.
- Page 24 • When asked the Spirotel will send an email with two files attached to the email address specified one in pdf format which allows of the test to be viewed immediately the other in a file gsm which can be saved on the PC and then opened with the software winspiroPRO.
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Page 25: Turbine Calibration
After the test go to the main screen and press the icon on the right. Spirotel will proceed with the connection chosen and at the end it will send back a message “DATA SENT”. It's possible to visualize the email inside the inbox set-up or alternatively at www.spirotel.com/demo. - Page 26 The correction of inspiratory volumes and flow rates is performed automatically thanks to an ambient temperature sensor that measures the temperature inside the device and allows the BTPS factor to be calculated. If a 3-litre syringe is used for the test and if the Spirotel is perfectly calibrated, the FVC (syringe) value measured will be: ®...
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Page 27: Showing The Current Patient's Last Session
• Slide the mouthpiece at least 0.5 cm along the groove on the turbine. • Fit the nose clamp over the patient's nostrils to prevent air from escaping. • Use both hands to hold the ends of the Spirotel . The screen should be facing to the right. -
Page 28: The Display And Reading Of Spirometry Results
Remember that for accurate spirometry results, it is essential that all the air is expelled from the lungs. The test can be repeated as often as required without the mouthpiece having to be removed from the mouth. In such event, the Spirotel ®... - Page 29 To avoid compromising the reliability of readings and to protect the sensor, do not twist the sensor cable or use excessive force when using, connecting, disconnecting or putting away the oximeter sensor. The first few seconds of a test are used for finding the strongest signal; once this has been found, the timer resets itself and the Spirotel ®...
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Page 30: Oximetry Test Classification
It is always possible to check the configuration by touching the icon itself. When one of the activated alarm conditions occurs, Spirotel will beep and the icon is displayed on the screen. If you press it, the acoustic alarm will be paused for 2 minutes. -
Page 31: Instructions For Using The Sensor On Adult Patients
The description of the following sensor serves solely an as example. Any of the sensors described in §1.2.4 can be used with the Spirotel device MIR do not recommend any particular sensor; that decision is left to the doctor's discretion. ®... -
Page 32: Data Transmission
When connecting for the first time, the Microsoft certified drivers that are needed will be automatically installed (depending on the OS in use). 3.2.1 Up-dating internal software When the device is connected to a PC via the USB port, the Spirotel internal software can be up-dated Up-dates can be downloaded ®... -
Page 33: Data Transfer Via Gsm
Spirotel ® User Guide Data transfer via GSM WARNING Check that the GSM function is available on the device you are using as it is optional on several models. Press on the main screen The device will automatically start the procedure for sending data in the archive to the preset server. -
Page 34: Maintenance
Never clean the turbine under running water or spray with other liquids. If no liquid detergents are available, clean the turbine with at least clean water. MIR recommends the use of Dupont Perasafe that has been tested on all MIR sensors. Rinse the turbine by immersing it in clean water (not hot). -
Page 35: Cleaning And Disinfection Of The Oximetry Sensor
If there is only one bar or if the device doesn't turn on, you will need to recharge the battery as follows: • Connect the battery charger to both the micro USB and mains supply, another way is to connect the Spirotel to a PC via USB. During recharging, the device is ®... -
Page 36: Trouble Shooting And Solutions
Spirotel ® User Guide TROUBLE SHOOTING AND SOLUTIONS PROBLEM MESSAGE POSSIBLE CAUSE SOLUTION Battery may be flat Charge the device using the charger unit The battery is not properly fitted in Contact technical services the device Spirotel doesn't turn ®... -
Page 37: Guarantee Conditions
MIR Medical International Research reserves the right to replace the product or make any changes to it that the company deems necessary.
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