Bright 015507 Pulse Oximeter Instruction Manual

Bright 015507 Pulse Oximeter

INTRODUCTION

• These instructions have complied in accordance with council directive MDD 93/42/EEC concerning medical equipment and harmonized standards.
• Product development and program upgrades can result in the information in this document being changed without prior notice.
• The product is a medical device for multiple use.
• Failure to follow all the instructions and safety instructions can result in a risk of measurement error, personal injury and material damage. The manufacturer cannot accept liability for any damage resulting from failure to follow these instructions. Failure to follow these instructions will invalidate the warranty.
• As a result of continuous product development the product and its technical data may deviate somewhat from the descriptions in these instructions. Please take this into consideration.
• The manufacturer has the preferential right of interpretation concerning the content in these instructions. We reserve the right to change the instructions without prior notice.

SAFETY INSTRUCTIONS

• Read these instructions carefully before use, and save them for future reference.
• Check at regular intervals that the product, its sensors and cabling are free from damage, and that there are no other factors that can influence its functionality or safety.
• This check should be carried out at least once a week. Do not use the product if t is damaged.
• Maintenance and any repairs must only be carried out by qualified personnel.
• The product does not contain any parts that can be repaired by the user.
• The product cannot used together with equipment that is not recommended in these instructions. Only use accessories recommended by the manufacturer.
• On delivery from the factory the product is calibrated to show functional oxygen saturation.
• Check that no parts or accessories are missing or damaged, and that the product works correctly.
• End of Iife product, batteries and all the packaging must be recycled in accordance with local regulations. Keep the packaging materials out of the reach of children – risk of suffocation!

WARNING

• Risk of explosion-do not use the product in explosive environments, such as in the vicinity of flammable liquids and gas (e.g. flammable anaesthetic gas) or flammable dust.
• Do not use the product on persons who have also been examined with magnetic resonance tomography or computer tomography- risk of burn injury as a result if induced current.
• The measurement resuts shown by the product must never consist of the only basis for a diagnosis.
• The product is only intended as a supplementary diagnostic aid.
• The product must only be used according to the instructions of the doctor and on the basis of experienced or measured symptoms of the patient.
• A function tester cannot be used to evaluate the precision of the product.
• Excessive use can result in discomfort or pain, especially for users with microcirculatory damage.
• The product’s measuring chamber should not be applied on the same finger for more than two hours.
• More stringent restrictions must be applied for some users. The product must not be applied on tender or damaged tissue, or tissue with oedema.
• The product emits both near-infrared light and invisible infrared radiation that is harmful to the eyes. Never look into the light source on the product.
• The product contains silicone, PVC, TPU, TPE and ABS plastic.
• The biocompatibility of these materials is tested and approved in accordance with the requirements in Iso 10993-1. Do not use the product on persons allergic to PVC, TPU, TPE or ABS.
• The product cannot be used on fingers with nail polish or other cosmetic or skin care products.
• The product is a measuring tool and has no therapeutic effect.
• Some function testers or patient simulators, for example INDEX-2UFE (software package version 3.00, see instructions), can be used to check whether the product is working properly.
• Some function testers or patient simulators can also be used to check the accuracy of the product’s copied calibration curve, but not to evaluate the precision of the product.
• Do not use the product near equipment that can generate strong electric or  magnet fields. The functionality of the product can affect or be affected by other equipment, for example, radio transmitters or industrial equipment that emits powerful electromagnetic radiation.
• Electrosurgery can also affect the measurement resuts.
• The simultaneous use of several products on the same patient can be dangerous as a result of simultaneous leakage currents.
• The product gives high measurement values for persons with carbon monoxide poisoning, which is why it should not be used in such cases.
• The product can be used by the patient for self-monitoring.
• Do not attempt to adjust or maintain the product when measuring is in progress.

IMPORTANT:

• Check that no circumstances or applied procedures at the clinic can damage the product or other equipment.
• Check before use that the product is working properly and that the operating conditions for the product are met.
• For best measuring accuracy the patient should be in a quiet and relaxed environment during the measuring.
• Do not expose the product to dusty conditions, vibrations, corrosive or explosive substances, high temperatures or high humidity.
• Do not use the product if it is wet.
• Allow the product to reach ambient temperature before use if it is moved from a cold place to a warm or moist place.
• Do not press the buttons on the product with pointed or sharp objects.
• The product must not be disinfected in an autoclave or by any other method in which high temperature or steam under pressure is used. Follow the instructions in the maintenance section. Remove the battery before cleaning and disinfection.
• The most reliable method for measuring oxygen saturation and pulse is obtained by placing a large finger, the middle finger or thumb, deep inside the measuring chamber. cold or thin fingers, or long nails produce unreliable measurements.
• The product is intended to be used on both children and adults.
• The product does not work on all persons and body types. stop using the product if you cannot obtain stable measurements.
• If an abnormal function or unreasonable measurements are obtained, pull out the finger and then return it to reset normal functionality.
• If an unknown error occurs during the measuring, switch off the product by removing the battery.
• The life span of the product is normally three years from the date of manufacture.
• The tissue temperature in the Sp02 measuring chamber should be less than 41°C. The product measures this temperature.
• Do not twist or knot the carry and hanger strap in an attempt to reduce the risk of dropping and damaging the product. The material in the product’s carry and hanger strap has been chosen to minimise the risk of an allergic reaction. Some persons can nevertheless suffer an allergic reaction- in which case, stop using the strap. To minimise the risk of accidents and personal injury, the strap should never be worn round the neck.
• The product has an undervoltage indicator, but does not have an undervoltage alarm. Pay attention to the indicator and replace the batteries when it shows low battery voltage.
• The product does not have high or low alarms for measurement results. For this reason, do not use the product to monitor patients or for other critical applications that require an alarm.
• If the product is not going to be used for a month or longer, remove the batteries to avoid damage from battery leakage.
• Do not subject the power cord to tension, twisting or other mechanical stress.
• The product’s signal processing and average value calculation results in a certain delay in updating the shown SpO2 value. The updating interval can change in relation to the pulse of the patient. When the interval is shorter than 30 seconds the time to calculate the dynamic average value increases.
• This can be a result of a reduction in signal quality, low perfusion or other problems or interference.
• The measuring requires a strong pulse on the patient. In the event of weak pulse, for example as a result of shock, severe chill, heavy bleeding or the use of vasoconstrictors, the oxygen saturation curve (plethysmograph) will attenuate. In such circumstances the measuring will be more sensitive to interference.
• Product or parts intended for disposable use must never be used several times risk of incorrect measurements and damage to the product.
• The manufacturer can on request provide information (circuit diagram, part lists, figures etc.) to make it easier for qualified technical personnel to troubleshoot and repair the product.
• The finger must be placed correctly in the measuring chamber  , otherwise an incorrect measurement will be obtained.
• The light between the light transmitter and receiver must pass through the patients finger arterioles. The ray trajectory must be free of plaster, tissue and other foreign material. strong daylight or strong artihcial light from xenon lamps in operating theatres, but also light from phototherapy lamps, fluorescent tubes or infrared heaters can affect the measurement results. To minimise interference from external sources of light, place the finger correctly in the measuring chamber and cover/screen the product With a suitable screen.
• The patient must not be moved or move during the measuring-movement of the body or exertion can affect the result.
• Measuring cannot be done on the part of the body strung with a blood pressure cuff or to which there is an intravenous supply.
• During or immediately after defibrillation the measurement results can be unreliable.
• Equipment connected to the product must comply with the requirements in IEC 60601-1.

SYMBOLS

TECHNICAL DATA

NOTES

1. The specified Sp02 precision should be confirmed with clinical measurements over the entire measurement range.
2. The oxygen saturation (Spo2) must by artificial means be kept stable in the range 70-100% and compared with the Sp02 values simultaneously measured with a secondary standard pulse oximeter so that paired data can be used for a precision analysis is created. 12 healthy, voluntary participants (6 men and 6 women aged 18-45, of which 2 with strongly dark pigmented skin, 8 with medium pigmented skin, and 2 with low pigmented skin) were included in the study.
3.  Because measurement values taken with pulse oximeter equipment are statistically distributed, only about two thirds of the values can be expected to lie within t Arms for the value measured with a CO-OXIMETER. Percentage modulation of the infrared signal as an indication of pulsating signal strength, the patient simulator has been used to verify precision with low perfusion. The Sp02 and pulse values differ as a result of low signal strength, compared with the known SpO2 and pulse values of the input signal.
4.  Both light sensors (light receivers) and light transmitters can affect and be affected by other medical equipment working in the same wavelength range. This should be taken into consideration by nursing staff conducting for example phototherapy.
5.  The precision of the pulse measuring has been verified with a patient simulator and is given as an effective value of the difference between asured pulse value and the pulse value set in the simulator.

OPERATING CONDITIONS

DESCRIPTION PARTS

1.  Power switch
2.  Oxygen saturation display
3.  Undervoltage indicator
4.  Pulse display
5.  Pulse indicator (bar)

OVERVIEW

Oxygen saturation (Sp0,) indicates how much of the total haemoglobin in the blood Consists of HbO,, which is a measure of the concentration of oxygen in the blood This is an important respiration and circulation parameter. Several respiratory illness Conditions can reduce the oxygen saturation (Sp02) of the blood. Dysfunctions in the body’s oxygenation and control systems, damage during surgery and other medical intervention or examinations, can also reduce the oxygenation of the body and result in diziness, impotence and nausea/vomiting. In more serious cases these symptoms can be life-threatening. The opportunity through rapid measuring to establish the patient’s SpO2 is therefore of great importance to detect and prevent potential danger in time. The measuring has a high degree of precision and repeatability and is done by the user quite simply inserting a inger in the opening in the IR measuring chamber. The oxygen saturation (Sp02) is shown on the display.

Applications

The product can be used to measure oxygen saturation and the pulse in the fingertips. The pulse strength is indicated with bars in the display. The product is suitable for both private domestic use and for use in health centres and hospitals, etc.

INSTALLATION BATTERY

1. Insert 2 batteries of size R03 (AAA) with the correct polarity.
2.  Replace the battery cover.

NOTE: Insert the batteries carefully- incorrect insertion can damage the product. A flashing battery symbol warns of low battery level.

FITTING THE STRAP

1. Slip one part of the strap through the hole.
2. Slip the other part of the strap through the first loop and tighten.

USE

FUNCTIONAL BASIS

The measurement data is processed in accordance with an empirical formula based on the Beer-Lambert law tor absorption properties for intrared radiation and near infrared light of reductive haemoglobin (Hb) and oxyhemoglobin (Hbo,). Measuring takes place with photocell technology, With two rays of difterent wavelengths focused on the fingertip through a measuring clip with fingertip sensor. The measurement signal is registered with a photocell and analysed with a microprocessor, after which the measurement result is show in the display.

1. Transmitter for infrared radiation and near-infrared light.
2.  Receiver for infrared radiation and near-infrared light.

Clinical limitations

• The measuring requires a strong pulse on the test subject. In the event of weak pulse, for example as a result of shock, severe chill, heavy bleeding or the use of vasoconstrictors, the oxygen saturation curve (plethysmograph) will attenuate.
• In such circumstances, the measuring will be more sensitive to interference.
• For persons with strong skin pigmentation or a high content of contrast fluid (for example methyl blue or indigo green), measuring oxygen saturation with this product can be unreliable.
• For persons with anemic hypoxia and toxic hypoxia, or hemoglobin disorders such as carbon monoxide-bound hemoglobin (HbCO), methionine-bound hemoglobin (HbMe) or sulfate-bound hemoglobin (HbSu), measuring oxygen saturation with this product can be unreliable. The product can in some cases indicate hypoxia, but further sampling with other methods is required Because Oxygen saturation measuring is used as a reference value for evaluation of anemic hypoxia and toxic hypoxia, some persons with serious hypoxia provide g0od oxygen saturation values.
• Contraindications: none.

HOW TO USE

1. Insert both batteries with the correct polarity if this has not already been done, and replace the battery cover.
2. Open the measuring chamber
3.  Insert the finger and put it on the rubber pads in the chamber, check that the finger is correctly positioned and close the chamber round the finger.
4.  Press the switch on the front panel.
5.  Sit still and hold the hand and finger still during the measuring.
6.  Read off the results.
7.  Open the measuring chamber and reset by pressing the button.

MAINTENANCE

• Clean and dry the product betore and after use in accordance with the following instructions.
• Replace the batteries when under voltage is indicated.
• Remove the batteries if the product iS not going to be used for some time.
• The product does not need to be calibrated in conjunction with maintenance

CLEANING

• Switch off the product and remove the batteries before cleaning.
• Do not immerse the product or batteries in water or any other liquid.
• Wipe the measuring chamber with a sott cloth moistened with a 75 per cent solution of alcohol.
• Wipe the carry strap and outside of the product with a soft cloth moistened with a soap solution or isopropanol and allow to dry, or wipe dry with a clean, soft cloth. Do not spray alcohol or any other liquid directly on the product or allow any liquid to penetrate the product.

WARNING!

• The product must not be sterilised in an autoclave.
• Do not immerse the product in water or any other liquid.

TRANSPORT AND STORAGE

• In suitable packaging the product can be transported by regular dispatch and transport companies, or by separate transport agreements. Protect the product from knocks and blowS, vibrations and precipitation or any other liquid.
• The product must not be transported together with dangerous or corrosive gods.
• The product should be stored in suitable packaging in a well-ventilated roomm free from a corrosive atmosphere and at a temperature of-40 to +60°C and a maximum relative humidity of 95%.

TROUBLESHOOTING

Oxygen saturation

{SpO)and pulse are not shown as usual

| ThefingerisnotcorrectlyposrtionedIn the measuring chamber.| Position the finger correctly, and try again.
The patient moves or does not keep the finger still.| Help the patient to remain completely still.
The operating conditions for the product have not been met| Use the product in the correct operating conditions.
The product has a malfunction| Contact there tailer.
Oxygen saturation

{SpO,)and pulse are not shown as stable.

| Thefingerisnotsufficientlyinsertedin the measuring chamber.| Position the finger correctly, and try again.
The patient moves or does not keep the finger still.| Help the patient to remain completely still.

Theproductdoes notstart

| The batteries are discharged.| Replace the batteries.
Thebatteriesareinstalledincorrectly| Insert the batteries correctly.
The product has a malfunction| Contact there tailer.

The display suddenly goes off.

| The product has switched to energy saving mode.| Thisisnotafaultand does not need to be addressed.
The batteries are discharged.| Replace the batteries.
The product has a malfunction| Contact the retailer.

ELECTROMAGNETIC COMPATIBILITY (EMC)

Guidelines and manufacturer’s certificate concerning electromagnetic compatibility for equipment and systems.

NOTE:

• The product must be used in an electromagnetic environment and in electromagnetic conditions in accordance with the following guidelines. Measurement errors can occur if the product is exposed to radio frequency or electromagnetic fields. Other equipment used near the product must therefore comply with the corresponding EMC requirements. Mobile phones, X-ray appliances and magnetic resonance tomographic equipment are potential sources of interference as they can emit electromagnetic radiation of high intensity.
• See previous chapter for minimum values for the user’s physiological signals.
• The measuring precision will be reduced when the product is working with values lower than the previously specified minimum values.
• The use of spare parts, accessories or cords other than those recommended or sold by the manufacturer can increase the electromagnetic radiation of the product or reduce its electromagnetic immunity.
• The product should not be used in the immediate vicinity of electrical equipment or placed between or over different electrical equipment. If such use is necessary, the functionality of the product must be checked to ensure that an unacceptable effect does not take place in configuration of equipment used.
• Units and systems can be interfered by other equipment even if it complies with the applicable national requirements.
• Basic performance: the absolute measurement precision Sp02 is t 2% within the range 70-100 %, and for pulse is t 2 beat/min or 2% (the larger of the values) within the range 30-250 beat/min.

GUIDELINES AND MANUFACTURER’S CERTIFICATE CONCERNING ELECTROMAGNETIC RADIATION

The product is intended to be used in electromagnetic environments in accordance with the specifications below. It is incumbent on the customer or the person using the product to ensure that the electromagnetic environment in which the product is used complies with these specifications.

GUIDELINES AND MANUFACTURER’S CERTIFICATE CONCERNING ELECTROMAGNETIC IMMUNITY

The product is intended to be used in electromagnetic environments in accordance with the specifications below. It is incumbent on the customer or the person using the product to ensure that the electromagnetic environment in which the product is used complies with these specifications.

GUIDELINES AND MANUFACTURER’S CERTIFICATE CONCERNING ELECTROMAGNETIC IMMUNITY

The product is intended to be used in electromagnetic environments in accordance with the specifications below. It is incumbent on the customer or the person using the product to ensure that the electromagnetic environment in which the product is used complies with these specifications.

Note 1: The higher frequency range is applicable at 80 MHz and 800 MHz.
Note 2: These guidelines do not apply in all situations. Electromagnetic radiation can be attected by absorption in and reflection against building structures and other objects, such as people.

• The field strength from permanent transmitters, e.g. base stations for mobile phones and wireless telephony, communication radios, amplitude or trequency modulated radio and television broadcasting, cannot be predicted theoretically with a practical degree of accuracy. In those cases where electromagnetic environmental impact from permanent radio transmitters is important, measurement of electromagnetic field strength in situ should therefore be taken into consideration. If the measured field strength in the place where the product is used exceeds the applicable, above specified compliance levels for radio frequency radiation, the product should be tested and checked to verity that it is working properly. Additional measures may be necessary if incorrect or abnormal functionality is observed, for example the realignment or repositioning of the product.
•  In the frequency range 150 kHz to 80 MHz the field strength should be less than 3 V/m. The recommended minimum distance between portable and mobile radio communication equipment and non-lite supporting equipment and systems.

RECOMMENDED MINIMUM DISTANCE BETWEEN THE PRODUCT AND PORTABLE AND MOBILE RADIO COMMUNICATION EQUIPMENT

The product is intended to be used in electromagnetic environments in which radiated radio frequency interference is controlled and limited. The customer or person using the product can reduce the risk of electromagnetic interference by maintaining the recommended minimum distance, given below on the basis of radio transmitted power, between the product and portable and mobile radio communication equipment. For radio transmitters where the rated power P Is not given in the table values the minimum distance d can be calculated with the applicable equation for the transmitter frequency, whereby the transmitting power Pis given in W.

• Note 1: The minimum distance for the higher frequency range is applicable at 80 MHz and 800 MHz.
• Note 2: These guidelines do not apply in all situations. Electromagnetic radiation can be affected by absorption in and reflection against building structures and other objects, such as people.

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