LA090401 - Measuring equipment LANAFORM - Free user manual and instructions

USER MANUAL LA090401 LANAFORM

Version 02 dated 01/08/2012 USER MANUAL INTRODUCTION Thank you for purchasing a LANAFORM® “PULSE OXIMETER”. This pulse oximeter permits the simple, reliable, non-invasive and continuous measurement of blood oxygen saturation and the pulse rate of both adults and children. A FEW WORDS ABOUT THE PULSE OXIMETER...

1. Field of application of the device

A pulse oximeter can be used to measure the functional oxygen saturation of arterial haemoglobin (SpO2) and heart rate. Placed on your finger, it can be used not only at home but also in a sports context, by medical-social organisations, etc. This device is not intended to be used for continuous monitoring.

2. General description

A pulse oximeter is a non-invasive method used to measure the oxygen saturation level in the blood (SpO2) by testing the haemoglobin percentage saturated with oxygen as well as measuring heart rate. This process has been in regular use for over 20 years and has become an essential test in medical practice for making sure that oxygen levels are maintained and breathing difficulties are prevented. The oxygen saturation value may be considered as dangerous if it is lower than 90% in the case of arterial blood. The normal value is 100% under normal atmospheric conditions. LANAFORM’S oximeter has the advantage of taking up little space, enjoys low energy consumption, is easy to handle and is portable. When you place your finger in the photoelectric sensor, a diagnosis of the haemoglobin saturation values measured as well as the heart rate are displayed directly.

3. Principle of measurement

The principle of measurement is based on the Beer-Lambert law. The principle is based on the emission of two lights (red and infrared) of 640 and 940 nm respectively and the measurement of their absorption by the pulsatile flux. The sensor comprises two diodes emitting a red light which must be located opposite an Version 03 dated 20/09/2012EN Version 02 dated 01/08/2012

easily identifiable receptor zone. The best results are obtained by placing the transmitter on the fingernail. The information acquired will then be displayed by two series of LEDs which process the information via electronic circuits and a microprocessor. TITLE AND DESCRIPTION OF THE SYMBOLS IN THE LEAFLET DESCRIBING THE PRODUCT: Symbol definition Identification Manufacturer’s information Manufacturer’s details LANAFORM SA • B-4141 SPRIMONT Batch number LOTA BF type devicePlease note, please see the instructions. Please note, please consult the attached documents. Please read these instructions before using the device. Please also follow these instructions carefully while using the device. Organisation notified

Waste electrical and electronic equipment (WEEE) Device not designed for continuous monitoring (no SpO2 alarm). Displays the percentage oxygen saturation Displays the pulse rate. Version 03 dated 20/09/2012EN

1. Do not use the pulse oximeter in an MRI room.

2. Keep the oximeter away from young children. The battery compartment cover as well as the strap

constitute a risk of strangling or suffocation.

3. Certain activities may expose you to injuries, including a risk of strangulation, if the strap wraps around

your neck. Use the strap with care.

4. Analysis of the measurements taken by this pulse oximeter is not a replacement for medical surveillance.

This is a matter simply of providing a source of additional information to communicate to people responsible for your care.

5. The oximeter can erroneously interpret an excessive movement as a good quality pulse signal. Please

remain immobile when using this device.

6. The oximeter must be able to measure the pulse correctly in order to give an accurate reading. Do not

place the device on the same hand or same arm as an armband or a blood pressure monitor.

7. Do not place the oximeter in a liquid and do not clean it with cleaners containing ammonium chloride,

alcohol or products not referred to in this user guide.

8. LANAFORM’S pulse oximeter is not designed for use in medical establishments.

9. The performance of the oximeter may be reduced under the following circumstances

- fluctuating or very bright light. - feeble pulse (feeble irrigation). - low haemoglobin rate. - arterial catheter. - nail polish and/or false fingernails. - recent tests requiring the injection of an intravascular colouring agent. Version 03 dated 20/09/2012EN Version 02 dated 01/08/2012

10. There is a risk that the oximeter will not operate if your blood circulation is weak. Rub your finger to

increase circulation or place the device on another finger.

11. The batteries may ooze or explode if they are not used properly or disposed of in a way that does not

comply with the regulations. Remove the battery if you intend storing the device for more than 30 days.

12. Do not use this appliance in a room where aerosol products (sprays) are used or in a room where oxygen

13. Do not use the oximeter outside the specified operating and storage temperature ranges.

14. Do not use the device for over 30 minutes without changing finger.

15. The oximeter must be used according to the instructions in the user guide.

Do not use this device close to strong magnetic fields, like for example those produced by cordless telephones or mobile phones.

17. Comply with local laws concerning recycling when disposing of the oximeter and its components,

including the batteries.

18. Always keep the oximeter away from sources of heat such as stoves and radiators, etc.

19. In case of problems with your device, please contact your reseller.

20. Do not try to repair the device yourself.

This device was not designed for use by people, including children, with reduced physical, sensory or mental capabilities, or people lacking experience or knowledge, unless they have had the benefit of prior supervision, advice and instruction in using the device from a person responsible for their safety. Children should be supervised to ensure that they do not play with the appliance.

22. This device must only be used when the ambient temperature is between 5 and 40°C.

23. Do not expose the device to electric shocks.

24. Do not expose this oximeter to extreme temperature conditions, that is temperatures higher than 60°C

or lower than -20°C.

25. Do not use this device if the relative humidity is greater than 80% or less than 30%.

Version 02 dated 01/08/2012 InSTRUCTIOnS DESCRIPTIOn OF THE DEVICE: Alarm/light OLED screen Mode button On/Off button Battery compartment cover ACCESSORIES Hanging cord User Manual Storage bag DESCRIPTIOn OF THE lCD SCREEn SPO2 wave Heart rate SPO2 DESCRIPTIOn OF THE OXIMETER’S DISPlAY The oximeter’s display interface can pivot automatically in four directions. The display direction changes automatically according to the parameters detected. In total, there are four types of display possible according to the four directions, as shown below: Version 03 dated 20/09/2012EN Version 02 dated 01/08/2012

Press the “M” button during operation, the appearance of the SPO2 wave will be displayed as follows: FUNCTIONS

4. Low energy consumption. Operates for 50 hours continuously.

5. Low perfusion ≤0.4%.

6. Battery charge indicator.

7. Automatic shutdown when there is no signal.

8. Small size and light weight. Easy to carry.

Installing the battery Insert two AAA batteries (not included) into the compartment making sure you comply with the polarity before replacing the cover. Instructions for use

1. Place your finger in the device, the fingernail uppermost, then release

the clips. For optimum results, make sure your finger is centred on the finger guide and hold the oximeter level with your heart or chest.

2. Press the On/Off button once.

3. Do not let your finger shake while the oximeter is operating. We

recommend that you do not move during operation.

4. The corresponding values are displayed on the display screen.

Low battery charge indicator When the battery has reached its lowest level, the red battery charge indicator symbol appears above the OLED screen. Heart rate alarm By default, the heart rate alarm triggers when the heart rate is greater than 110 BPM or less than 50 BPM. A red indicator then flashes above the OLED screen. If the heart rate is between 50 BPM and 110 BPM, a green indicator is displayed at the top of the screen. Version 03 dated 20/09/2012EN Version 02 dated 01/08/2012

- Use a surgical spirit solution to clean the rubber part in contact with the finger inside the oximeter, and clean this part before and after each use. Comment: (This part contains no toxins and is not at all toxic to human skin). - Make sure you clean the OLED screen using a slightly damp cloth. - Make sure you remove the battery from your device when you do not intend using it for a while. PROBLEMSOLVING Should you encounter one of the following problems while using your PULSE OXIMETER, please consult this guide to help you solve the problem. If the problem persists please contact your reseller. Problems Possible reasons Solutions The SpO2 and pulse measurement display is unstable Your finger is not correctly positioned inside the device. Position your finger correctly and try again. Position your finger correctly and try again. Keep still during measurement. The device does not switch on The batteries are discharged. Change the batteries. The batteries are not inserted correctly. Reinsert the batteries. There is a problem with the device. Contact the supplier or the after sales service. The indicator light goes out suddenly The device switches off automatically when it has not received a signal for 8 seconds. Normal. The batteries are almost discharged. Change the batteries.

ADVICE REGARDING THE DISPOSAL OF WASTE

• All the packaging is composed of materials that pose no hazard for the environment and which can be disposed of at your local sorting centre to be used as secondary raw materials. The cardboard may be disposed of in a paper recycling bin. The packaging film must be taken to your local sorting and recycling centre. Version 03 dated 20/09/2012EN

• When you have finished using the device, please dispose of it in an environmentally friendly way and in accordance with the law. Prior to disposal, please remove the battery and dispose of it at a collection point so that it can be recycled. Please note: under no circumstances should spent batteries be disposed of with household waste!!! lIMITED WARRAnTY LANAFORM® guarantees this product against any material or manufacturing defect for a period of two years from the date of purchase, except in the circumstances described below. The LANAFORM® guarantee does not cover damage caused as a result of normal wear to this product. In addition, the guarantee covering this LANAFORM® product does not cover damage caused by abusive or inappropriate or incorrect use, accidents, the use of unauthorized accessories, changes made to the product or any other circumstance, of whatever sort, that is outside LANAFORM®’s control. LANAFORM® may not be held liable for any type of circumstantial, indirect or specific damage. All implicit guarantees relating to the suitability of the product are limited to a period of two years from the initial date of purchase as long as a copy of the proof of purchase can be supplied. On receipt, LANAFORM® will repair or replace your appliance at its discretion and will return it to you. The guarantee is only valid through LANAFORM®’s Service Centre®. Any attempt to maintain this product by a person other than LANAFORM®’s Service Centre will render this guarantee void. DEClARATIOn OF EC 0029 COMPlIAnCE Medical Device Class IIa. We, LANAFORM, Declare that the “OXYMETER LA090401” complies with European Directive 93/42/EC concerning medical devices and its latest amendment 2007/47/EC. APRAGAZ 156 chaussée de Vilvoorde 1120 Brussels (Belgium), notified body No. 0029, checked the product (according to Appendix IV). Version 03 dated 20/09/2012FR

Version 03 dated 20/09/2012FR

Version 03 dated 20/09/2012SN

Version 03 dated 20/09/2012SN