Indications 

This medical device is designed for medical diagnostic purposes only. The device is meant to be used strictly according to instructions. Please read this user manual thoroughly before using the device and keep it for future reference. The manufacturer/importer is not responsible for the safety, reliability and performance issues and any monitoring abnormality, personal injury and equipment damage due to user’s negligence. The Oxysmart II Fingertip Pulse Oximeter is a compact, lightweight portable device easily transportable. 

The PraxilineTM Oxysmart II Finger Pulse Oximeter is a non-invasive device used for measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO₂) and the pulse rate. It is used on fingers (except the thumb) for discontinuous monitoring of adults. For children, one should use a paediatric external sensor Oxysmart II (optional).

 Instructions for Use 

To switch on the finger pulse oximeter, press the power button on the front panel. The screen can be displayed in 4 directions: To change orientation of the screen, press lightly on the power button. Insert the patient’s finger (nail side up) into the unit.  Make sure the finger is in contact with the sensor, then clip the finger. The SpO₂ value and the heart rate, as well as the pulse rate wave and bargraph will be displayed on the screen. The finger should lay flat (not on the side) and be centred within the device. Low finger temperature or improper positioning could cause inaccurate measurement.  For best results, keep Oxysmart II at the patient’s heart or chest level. Minimize his/her motion as much as possible and keep the patient at ease during the process. Do not fix the Oxysmart II with any adhesive materiel as it may modify blood pulsation and provide inaccurate measurements.  While the finger is in place, do not press or squeeze on the device. The internal spring provides the correct pressure ; additional pressure may cause inaccurate readings. Verify that nothing is hindering the pulse measurement. If the device does not turn on, remove the finger and wait a few seconds before reinserting it. The device has an automatic power shut-off function, which turns the power off within 5 seconds after the finger is removed. When in set-up mode, the devise does not switch-off. 

Menu set up 

 

Push the power button for several seconds to display the configuration menu. When the settings menu appears, shortly press the button to scroll down the menu. Once an item is selected, pressing the button for several seconds gives access to sub menus and allows you to modify the set-up configuration. To exit the setting, select “Exit” and press continuously. Note : The menu can be displayed only if the text orientation is horizontal. 

1. Screen brightness: Select the mode “Brightness”. Press the key continuously to adjust the backlight lightness (4 levels of brightness).

2. Alarm: Adjusting the SpO₂ and pulse rate upper and lower limits. Activation and desactivation of the sound alarms.     

     a) Alarm levels set-up: Enter the menu “Alarm”, then click on the sub menu “Dir” and press continuously to select the mode “Up” or “Down”. Select menu “Up” to raise the SpO₂ and Pulse rate alarm limits. Choose the menu “Down” to lower the rates.  Move the curser to select the item to be set, then exert a longer pressure to modify the alarm levels. SPO2 ALM HI : SpO₂ High LimitSPO2 ALM LO: SpO₂ Low LimitPR ALM HI: Pulse rate High LimitPR ALM LO: Pulse rate Low Limit  

      b) Alarm and Pulse sound set-up : Activation and desactivation of the SpO₂ and pulse rate alarms and the Pulse sound :          

           */  To activate the SpO₂ and pulse rate alarms,  select “Alarm”         

          */  To activate the pulse sound function, select “Pulse sound” When the curser in on the selected item, press continuously to select “On” to activate the alarm or “Off”, to desactivate it. 

3. UBS : Display and data transfer via USB The data display and data transfer software can be downloaded from here. Real-time data can be displayed on the computer screen. When the application is launched, connect the USB cable to the device. In the main menu, select „USB“, move the curser to „On“ to display the real-time data. Select „Off“ to turn off the display. 

4. Record : A measurement can be recorded and saved to the device’s memory for 24 hours. By selecting « Record », you can set-up the time of the recording. Then select « Y » to active the recording. To return to the recording, select the sub menu « Record » and then select « n ». Note : When a new measurement is recorded, the last recorded one will be automatically erased.When a recording is activated, the oximeter does not shut down automatically. 

5. Upload : To enable data transfer, the „USB“ function must be activated (in the sub menu „USB“, select the „On“ mode) and desactivate the „Record“ function (in the sub menu „Record“, select the „Off» mode). Launch the software (download here) then connect the USB cable.  In the main menu, select « Upload ». Chose the mode „On“ to transfer the data to the computer. When the transfer is completed, the mode „Off“ is automatically activated. NB : This function allows data transfer to the computer, it does not allow downloading to the oximeter. 

Warning 

Do not use the device in an MRI environment, in an inflammable atmosphere.  On infant or neonatal patients use a paediatric sensor. Strenuous action of the patient or electrosurgical interference may also affect measurement accuracy or device operation. If you need to use Oxysmart II in conjunction with other electronic devices, verify that the oximeter operates normally. The device is not appropriate for the ceaseless monitoring of the patient. It is recommended not to apply the sensor on the same finger for more than 2 hours. The infrared light is harmful to the eyes, avoid any eye contact. Dysfunctional haemoglobin, week pulse due to shock, low ambient/body temperature, major bleeding, usage of drugs or intravascular dyes may affect the accuracy of the SpO₂ measurement. Patient sensitivity to sensors may vary due to medical status or skin condition. Do not clip on an oedema or wound. Light variation or excessive ambient light, blood pressure cuffs, perfusion lines, low blood pressure, arterial catheters, nail polish, long and/or artificial nails, moisture, etc., may limit the device’s performance. 

Charging/changing the battery 

One rechargeable lithium battery (3.5 V) powers the Oxysmart II for about 12 hours of continuous operation. Prior to first use, charge the battery completely. When the battery indicator level is low, the device may not operate normally, and battery needs be recharged. The battery can be recharged with a power adapter or via the USB cable connected to the computer. While the battery is being recharged, an indicator light will flash. Even if the oximeter is not used regularly, the battery should be fully recharged at least once every six month. This will extend the battery life. The battery should be changed when it does not provide power for more than 10 minutes or if the battery cannot be recharged. 

General Use and Maintenance 

The Oxysmart II requires a calibration once a year. It does not require any maintenance. Do not operate the key on the front panel with sharp objects. Do not open the Oxysmart II case and do not make any repairs. Opening the case may damage the Oxysmart II and void the warranty. Maintenance is to be performed by qualified technicians only. Keep the oximeter away from extreme heat and cold, solvents and oils, dust, moisture and vibrations. Avoid prolonged exposure to direct sunlight. General cleaning instructions Routinely cleaning the oximeter will ensure its optimal performance. The oximeter may be wiped with a 70% isopropyl alcohol solution. Do not immerse the oximeter in any liquid, do not sterilise, do not use high pressure steam disinfection or use caustic or abrasive cleaning agents. 

Warranty 

The PraxilineTM Oxysmart II Finger Pulse Oximeter is warranted against any defects in material and workmanship for a period of 2 years from date of purchase within normal conditions of use. Warranty claims do not apply in case of improper handling, non-compliance with the content of the User Instructions, any changes or repairs carried out by non qualified persons. During the warranty period, all defective parts will be replaced or repaired free of charge upon return of the device. In case of warranty claim or repair, please return the entire device, and its original invoice and in original packaging. 

Follow the legislation of your country for sale conditions, usage and recycling instructions regarding disposal or recycling of the device and device components, including batteries.

Accessories:

     A lanyard cord
     A Battery Charger
     An USB cable

 Download your software here