PO100 - Heart rate monitor LANAFORM - Free user manual and instructions

USER MANUAL PO100 LANAFORM

P O -1 0 0 PULSE OXIMETER OXYGEN SATURATION PULSE RATE PERFUSION INDEXENGLISH Introduction Thank you for choosing the pulse oxime- ter by LANAFORM. The Pulse Oximeter is a non-invasive method used to measure blood oxygen saturation ( SpO

) by checking the percent- age of oxygen-saturated haemoglobin as well as the Perfusion Index (PI) and heart rate measurement. This process has been in regular use now for twenty years and is proving to be an essential control in medi- cal practice for maintaining oxygen levels and preventing respiratory problems. The value of the oxygen saturation may be re- garded as dangerous if it is below 90% for arterial blood. Normal value is 100% under normal atmospheric conditions. Please read all the instructions before using your product, particularly these basic safety instructions. The photographs and other images of the product in this manual and on the packaging are as accurate as possible, but do not claim to be a perfect repro- duction of the product. Contents 01 Unpacking 02 Contents of the package 03 Symbols 04 Safety precautions 05 Product description 06 Product structure 07 Description of the screen 08 Settings 09 Instructions for use 10 Reading the measurements 11 About the display 12 Replacing the batteries 13 Fixing the strap 14 Cleaning and disinfecting routine 15 Maintenance 16 Technical specications 17 Safety category 18 Storage et transport 19 Manufacturer’s guidelines and declaration - Electromag- netic emissions 20 Limited warranty 21 Waste disposal 22 After-sales service 01 Unpacking Please open the packaging carefully be- fore use. Check whether all the accessories are present and whether any components have been damaged during transport and follow the installation and operating in- structions in this manual. In the event of any damage or malfunction, please con- tact the reseller or Lanaform directly. In the event of any complaint, you will need the model of the device, serial number, date of purchase, your details and your address.02 Contents of the package

• 2 AAA batteries (supplied)

• 1 set of instructions for use

• 1 carrying cord 03 Symbols The following marks and symbols may appear in the instructions for use, on the PO-100 and its accessories. SYMBOL DESCRIPTION Type BF applied part. Due attention required. Action that is prohibited. Information about the manufacturer. Date of manufacture. Consult the instruc- tions for use. This product also complies with the requirements of di- rective MDD93/42/EEC. SYMBOL DESCRIPTION Electrical waste must be sent to a specialist collec- tion point for recycling. Level of protection against water penetration. Warning Misuse of the device can damage the oximeter or cause physical injury.

Please note Misuse of the device can damage the oximeter or cause inaccurate readings. %SpO

Symbol of oxygen saturation bpmPR Symbol of pulse rate No SpO

alarms. 04 Safety precautions Read the following precautions care- fully before using the pulse oximeter. Please note

Do not try to maintain the oximeter unless you are a qualified profes- sional. Only qualied maintenance professionals are authorised to carry out internal maintenance if necessary.

• The oximeter might not run if you have poor blood circulation. Rub your nger to increase circulation or put the de- vice on another nger.

Do not use the device for more than 30 minutes without changing ngers.

• This product is not suitable for exam- ining new-borns.

• Seek prompt medical treatment if the value measured is beyond the normal range and you are sure that the instru- ment is not malfunctioning.

Do not expose your eyes directly to the electroluminescent components of the oximeter because this might cause damage.

For further details on clinical limits and contraindications, please read the rel- evant medical documentation carefully.

The following factors may disrupt or aect the accuracy of the examination:

This product is used in an environment involving high-frequency devices.∙ The oximeter probe is place on the same part of the body or same limb as with the arterial duct of the blood pressure cu. ∙ The user suers from hypotension, severe vascular atrophy, severe anae- mia or lack of oxygen.

The user is in sudden cardiac ar- rest or in shock. ∙ Nail polish or false nails may cause incorrect oxygen saturation or pulse readings.

• Take care of the measuring probe lens, which is fragile.

Remove used batteries with care. In order to protect the environment, used batter- ies should be sent to a collection point provided for this purpose.

Remove the batteries when the oximeter is not in use for more than two months.

Do not immerse the oximeter in water or expose it directly to sunlight.

Clean the oximeter probe after each time it is used.

Do not use the oximeter for purposes not specied in this manual. Follow the in- structions in the chapter “Instructions for use” and use the oximeter with care.

The oximeter is not watertight so do no immerse it in water or any other liquid. Clean and disinfect the oximeter as de- scribed in the “Cleaning and disinfecting routine” chapter.

Keep the measuring probe clean to maintain the accuracy of the readings.

• The ambient temperature must not be too high or too low. For accurate read- ings, keep the oximeter at an ambient temperature for more than 30 minutes before using it.

• Do not use the oximeter at an ambient temperature above 40°C (104°F) or be- low 5°C (41°F). These temperatures are beyond the oximeter’s operating range.

Risk of pollution! The recommendation is that the used oximeter should be de- posited in a recycling centre.

2×1.5V AAA batteries (supplied) are the only replaceable accessories of the ox- imeter. Do not use batteries of other voltages or specications. Warning

Do not use the oximeter in an envi- ronment containing ammable gases, ammable anaesthetic or other am- mable substances.

Do not use the oximeter in an MRI or CT environment.

Do not use the oximeter when it is humid with overow or water vapour conden- sation. Do not move the oximeter from an excessively cold environment to a high-temperature humid environment.

Keep the oximeter out of the reach of children.

• Use of a used oximeter could cause in- accurate readings.

The oximeter is not designed to diag- nose or treat a health problem or illness.The results of measurements are pro- vided for information only.

Self-diagnostics or self-medication based on the results obtained are dan- gerous. Please consult a doctor.

• Do not try to charge dry-cell alkaline batteries and do not throw them onto a re. They could explode.

• Do not dismantle the oximeter and do not try to repair it. It could be perma- nently damaged.

• During the measuring process, do not use a mobile phone or any other de- vice likely to cause electromagnetic interference. 05 Product description Based on entirely digital technology, the nger pulse oximeter measures in a non-in- vasive manner the actual content (oxygen saturation) of oxyhaemoglobin (HbO2) in arterial blood by using the optical trans- mission method. The nger pulse oximeter measures the blood’s oxygen saturation and the pulse of a human body via the nger’s artery. It applies to a wide range of areas, such as families and clinics. Use this instrument for measuring before or after sport. Use of this instrument is not recommend- ed during sports activities. Do not use it for the continuous treatment of patients. 06 Product structure 1

01 OLED screen 02 Power button 03 Battery cover 04 Battery cover lock 07 Description of the screen 2

After turning on the oximeter, hold the power button down for about a second. The oximeter displays a conguration in- ter face. Press the button or hold it down to carry out the corresponding operations: hold it down to dene a part or press it once to change option or display mode.Adjusting its alarm Hold the power button down for 1 second while the oximeter is on. The congu- ration interface 1 is displayed, as the illustration shows. Move “*” to the corresponding option by continually pressing the power button. Hold the power button down for 1 sec- ond to activate/deactivate the alarm: when ALM is activated and the measured val- ues of the oxygen saturation of the blood and pulse exceed the top or bottom lim- it, the oximeter emits a sound alert. Hold the power button down for 1 second to activate/deactivate the beep: when the beep is activated, a tick-tack will be heard with the pulse beats when the pulse rate is being measured. While the “*” re- mains on the Restore option, hold down the power button for 1 second to restore the factory settings. Brightness settings Press the power button on the settings 1 interface to select the Brightness op

tion, then hold the button down to adjust the brightness on a value between 1 and

5. The higher the value, the higher the

screen’s brightness. Adjusting the alarm range On settings interface 2 (hold the power button down for 1 second when you are in the settings 1 interface and the “*” sym- bol is displayed on Alarm Setup), press the power button to switch between options. You can dene the upper and lower lim- its of the “SpO

” oxygenation rate alarm on this interface as well as the upper and lower limits of the “PR” pulse rate alarm. While the “*” symbol remains on option +/-, hold the power button down for 1 sec- ond to adjust the option to + or -. In + mode, select the corresponding option and hold the power button down to increase the up- per or lower limit. In - mode, hold down the power button to reduce the upper or lower limit. Move “*” to the Leave option and hold the power button down to return to the monitoring interface. 09 Instructions for use

Insert a nger fully into the oximeter’s measuring sections. Keep the surface of the nail pointing upwards and release the clip. Press the power button to switch on the oximeter.Warning If you do not insert your nger fully into the cavity, the measuring result may be inaccurate. Warning Do not allow your nger to vibrate during the measuring process. Preferably, make sure your body does not move. Once the readings have become stable, read the measured values of oxygen saturation and pulse on the screen. Comment: the oximeter will switch o automatically 10 seconds after remov- ing your nger. 10 Reading the measurements Evaluate the pulsed oxygen saturation index Warning The table below for evaluating your re- sults does NOT apply to people with certain pre-existing conditions (for example, asthma, heart failure, respiratory tract diseases) and in the event time is spent at altitudes higher than 1,500 metres. If you already have an illness, always consult your doctor for an evaluation of your results. SPO2 RESULT (PULSED OXYGEN SATURATION) IN% CLASSIFICATION/ MEASUREMENT

99-94 Normal range 94-90 Reduced range: Visit to the doc- tor recommended <90 Critical range: Consult a doctor in an emergency Evaluate the Perfusion Index The Perfusion Index (PI) must be between 0.3% and 20%. It uctuates depending on the patient, the measuring point and physical state. A very low PMI value may interfere with the measurements. 11 About the display

Press the power button continuously during the monitoring process. The data monitored and display method will be displayed cyclically on the OLED screen in two dierent ways (large fonts and plethysmograph) and in four directions, as shown in the illustration.12 Replacing the batteries 6 Replace the batteries when low and when the symbol ashes on the screen. Install two AAA dry-cell batteries in the battery compartment according to the polarity in- dicated and replace the battery cover. 13 Fixing the strap 7 You can x a strap to the device to make it easier to carry the pulse oximeter. Slide the thin end of the strap through the holder as illustrated. Firmly pull the other end of the strap through the holder of the narrow end. 14 Cleaning and disinfecting routine Cleaning Turn o the instrument and remove the batteries before cleaning. Make sure the instrument looks clean, is free of dust and dirt. Clean the instrument’s outer surface (including the OLED screen) with 75% med

ical spirit and a piece of soft, dry cloth. Make sure the liquid does not run into the instrument when cleaning. Do not immerse any part of the instru- ment in any liquid. Disinfection Before measuring with the instrument, clean the rubber pad with a piece of soft, dry cloth soaked in 75% medical spirit. Clean the nger to be measured with medical spirit for the purposes of disin- fection before and after use. Warning Do not disinfect the instrument by disin- fecting at a high temperature/high pressure or with gas. 15 Maintenance

Remove the batteries from their cas- ing and store them properly if you do not intend to use the oximeter for a lengthy period.

• Store the oximeter between 14°F and 122°F (–10°C to +50°C) and at levels of humidity of between 10% and 93%.

Check the oximeter regularly for damage.

Do not use the oximeter in an envi- ronment containing ammable gases or use it in an environment where the temperature or humidity is excessive- ly high or low.

• Check the accuracy of the oxygen sat- uration and pulse rate measurements using an appropriate calibration device.16 Technical specications 01 Dimensions: 62.0 mm (Width) × 37.0 mm (Depth) × 32.0 mm (Length) Weight: 42.5 g (includ- ing two AAA dry-cell batteries) 02 Peak wavelength range of light emitted by the probe: red light 660 nm ±3; 905 nm ±5 infrared light. 03 Maximum optical output pow- er of the probe: 1.2 mw for infrared light (905 nm). 04 Date of manufacture: see label 05 Normal working condition Operating temperature 5°C to 40°C (41°F to 104°F) Relative humidity 15% to 80%, no condensation Atmospheric pressure 70 kPa to 106 kPa Voltage rating DC 3.0 V 06 Default values and warn- ing conditions SETTING VALUE Oxygen sat- uration Upper limit: 100 Lower limit: 94 Heart rate Upper limit: 130 Lower limit: 50 Warning condition When the warning switch is activated and the ac- tual measured value exceeds the predened range of warning set- tings, the oximeter emits a warning sound. 07 Technical settings SETTING VALUE DISPLAY RANGE Oxygen saturation 35% to 100% Heart rate 25 bpm to 250 bpm RESO- LUTION Oxygen saturation

Heart rate 1 bpm SETTING VALUE ACCURACY OF MEASUREMENT Oxygen saturation ±2% (70% to 100%) No require- ment (≤ 69%) Heart rate ±2 bpm WARNING RANGE Oxygen saturation Upper limit: 50% to 100% Lower limit: 50% to 100% Heart rate Upper limit: 25 bpm to 250 bpm Lower limit: 25 bpm to 250 bpm WARNING RANGE Oxygen saturation ±1% of the pre

dened value Heart rate The highest of ±10% of the predened value and of ±5 bpm PI Low PI Min. 0.3% 17 Safety category

Type of protection against electric shocks: internally powered equipment.

Level of protection against electric shocks: type BF applied part.• Level of protection against water pen- etration. IP22

Safety level for use in ammable anaes- thetic mixtures with air, oxygen or nitrous oxide: non-AP/APG

No part of the oximeter’s application impedes the debrillation load eect.

No part of the oximeter’s application impedes the output signal.

• The oximeter is not a permanently in- stalled device. 18 Storage and transport The pulse oximeter can be transported using general transport tools. Avoid vi- brations, shocks or rain during transport. The pulse oximeter must be packed and stored on well-ventilated premises with no corrosive gas. The ambient tempera- ture must be between -10°C et +50°C, the relative humidity must be between 10% and 93% (with no condensation) and the atmospheric pressure must be between 50 and 106 kPa. 19 Manufacturer’s guidelines and statement · Electro- magnetic emissions Manufacturer’s guidelines and declaration · Electro- magnetic emissions · For all equipment and systems Manufacturer’s guidelines and declaration · Electromagnetic emissions The PO-100 pulse oximeter is designed to be used in the electromagnetic environment specied below. The customer or user of the PO-100 pulse oximeter must make sure that he or she uses it in this type of environment. Emission test Compliance Electromagnetic environment · Guidelines RF emissions · CISPR 11 Group 1 The PO-100 pulse oximeter only uses RF energy for its internal operation. The RF emissions are therefore very weak and should not cause any interference with the electronic devices nearby. Manufacturer’s guidelines and declaration · Electromagnetic emissions RF emissions · CISPR 11 Category B The PO-100 pulse oximeter can be used in any establishment, including domestic settings and those directly connected to the low-voltage public distribution network supplying electricity to buildings used for domestic purposes. 20 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 cov- er damage caused as a result of normal wear to this product. In addition, the guar- antee covering this LANAFORM product does not cover damage caused by abu- sive or inappropriate or incorrect use, accidents, the use of unauthorized ac- cessories, changes made to the productor 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 specic 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 re- place your appliance at its discretion and will return it to you. The guarantee is only valid through LANAFORM’s Service Cen- tre. Any attempt to maintain this product by a person other than LANAFORM’s Ser- vice Centre will render this guarantee void. 21 Advice regarding the disposal of waste All the packaging is composed of materi- als 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 lm must be taken to your local sorting and recycling centre. When you have nished using the device, please dispose of it in an environmentally friendly way and in accordance with the law. Prior to disposal, please remove the bat- tery and dispose of it at a collection point so that it can be recycled. Under no circumstances should spent bat- teries be disposed of with household waste. 22 After·sales service Shenzhen Jumper Medical Equipment Co., Ltd. D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, Guangdong, China Tel: [phone] MedPath GmbH, Mies-van- der-Rohe-Strasse 8, 80807 Munich, Deutschland Tel: [phone] Lanaform SA Rue de la Légende 55, 4141 Louveigné, Belgique Tel: [phone]FRANÇAIS Présentation Merci d’avoir choisi l’oxymètre de pouls de LANAFORM. L’oxymétrie de pouls est une méthode non invasive utilisée pour mesurer le niveau de saturation d’oxygène dans le sang (SpO

• 2 piles AAA (fournies)