MIROxi
User Manual cod. 980265
Rev 1.6
Page 3 of 32
INDEX
1.
INTRODUCTION...................................................................................................................................................... 4
1.1
Intended Use.................................................................................................................................................... 4
1.1.1
User Category ............................................................................................................................................. 4
1.1.2
Ability and experience required ................................................................................................................... 4
1.1.3
Operating environment................................................................................................................................ 4
1.1.4
Who can or must make the installation........................................................................................................ 4
1.1.5
Subject effect on the use of the device........................................................................................................ 4
1.1.6
Limitations of use - Contraindications.......................................................................................................... 4
1.2
Important safety warnings ................................................................................................................................ 5
1.2.1
Danger of cross-contamination.................................................................................................................... 5
1.2.2
Oximetry sensor .......................................................................................................................................... 5
1.2.3
Device ......................................................................................................................................................... 6
1.3
Unforeseen errors ............................................................................................................................................ 6
1.4
Labels and symbols ......................................................................................................................................... 7
1.4.1
Identification label........................................................................................................................................ 7
1.4.2
CE mark for medical devices....................................................................................................................... 7
1.4.3
Electrical safety symbol............................................................................................................................... 7
1.4.4
Warning symbol for the RS232 serial port................................................................................................... 7
1.4.5
Warning symbol for the USB serial port ...................................................................................................... 7
1.4.6
Warning symbol for the SpO2 port for oximetry........................................................................................... 7
1.4.7
Warning symbol for the WEEE.................................................................................................................... 7
1.4.8
FCC Warnings............................................................................................................................................. 8
1.5
Product description .......................................................................................................................................... 8
1.6
Technical specifications ................................................................................................................................... 9
1.6.1
Other features ........................................................................................................................................... 11
2.
FUNCTIONING OF THE MIROxi............................................................................................................................ 11
2.1
Keyboard........................................................................................................................................................ 11
2.2
Battery Level .................................................................................................................................................. 13
2.3
Information ..................................................................................................................................................... 13
2.4
Initial Set-up ................................................................................................................................................... 13
2.5
Patient Data ................................................................................................................................................... 15
2.6
Displaying data in memory............................................................................................................................. 16
2.7
Online operating mode (connected to a PC) .................................................................................................. 16
2.8
Oximetry testing ............................................................................................................................................. 16
2.8.1
Walk Test (6MWT) .................................................................................................................................... 18
2.8.2
Sleep Oximetry.......................................................................................................................................... 19
2.8.3
SPO2 BPM Oximetry Test......................................................................................................................... 19
2.8.4
SPO2 BPM Test ........................................................................................................................................ 20
2.8.5
Adult Single Patient Sensor – Instructions for Use .................................................................................... 20
2.8.6
Instruction for the belt and holder .............................................................................................................. 21
3
DATA TRANSMISSION ............................................................................................................................................. 21
3.1
Wireless Data Transmission via Phone Line (optional function)..................................................................... 21
3.2
Data Transmission via Bluetooth to a cell phone ........................................................................................... 22
3.2.1
Preliminary Operations .............................................................................................................................. 22
3.2.2
Setting the Phone Number ........................................................................................................................ 22
3.2.3
Bluetooth Data Transmission .................................................................................................................... 22
3.3
Data Transmission via Bluetooth for printing.................................................................................................. 22
3.4
Connection to a PC through USB port ........................................................................................................... 23
3.5
Connection to a PC through the RS232 ......................................................................................................... 23
3.6
Upgrade Internal software.............................................................................................................................. 23
4
MAINTENANCE......................................................................................................................................................... 23
4.1
Cleaning the oximetry sensor......................................................................................................................... 24
4.2
Changing the adhesive tape of the wrap sensor ............................................................................................ 24
4.3
Changing the Batteries................................................................................................................................... 24
5
PROBLEM SOLVING................................................................................................................................................. 24
5.1
Causes and Solutions .................................................................................................................................... 25
LIMITED WARRANTY CONDITIONS ............................................................................................................................... 27
ANNEX 1
OXYMETRY TEST REPORT EXAMPLES ................................................................................................ 28
ANNEX 2
INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT ........................... 31
