ROSSMAX InnoTec Corporation

SB100 Fingertip Pulse Oximeter Instructions for Use

Instructions for Use

1 Page

SB100 Fingertip Pulse Oximeter Instruction for Use 1.  4.  Top View  Bottom View  Safety information  1  8  WARNING: The SpO2 device is to be operated  2  7  by trained personnel only.  3  WARNING: Do not use the SpO2 device in the presence of flammable explosion hazard.  anesthetics  to  4  prevent  WARNING: Do not use the SpO2 device in the Magnetic Resonance Imaging (MRI) ambience. WARNING: The SpO2 readings and pulse signals can be affected by the conditions of ambience and patient. WARNING: Do not open up the SpO2 device except for the battery cover. The SpO2 device is without any user-serviceable part inside and only qualified service personnel can perform maintenance service. WARNING: Do not expose the SpO2 device to extreme moisture (such as rain) to ensure accurate performance and device safety. WARNING: If the accuracy of measurement by the SpO2 device is uncertain, check the patient’s vital signs by alternate means. Warning: This device is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: Reposition the device at least once every 4 hours to allow the patient’s skin to breath. WARNING: The SpO2 device is not intended for the use of neonatal. WARNING: Do not use the SpO2 device with other devices (such as, the cuff of blood pressure monitor) that may interfere with blood flow and cause inaccurate measurement. Warning: The SpO2 device will be affected by electromagnetic interference during operation. Warning: Please remove the batteries from the battery compartment if the device will not be used for a long period of time. 2. Introduction The Fingertip pulse oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults and pediatric at hospital, clinics, and/or home. The device contains a dual light source (Red LED and Infrared red LED) and a photodetector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. There is no visual or audio alarm.  3.  Product introduction  Features   Measure and display reliable SpO2 value and heart rate.  Single turn-on key for easy operation.  Bright LED display.  Light, compact, and portable.  Battery power is for a continuing use of 16 hours.  Two AAA Alkaline batteries for power supply.  Device will be off automatically after 8 seconds in idling.  6  5 1  % SpO2 signal  5  Power On/Off Button  2  Pulse strength  6  Battery compartment  3  Pulse rate  7  4  Beats per minute  8  SpO2 icon Battery indicator  5.  Operation  Open up battery compartment cover carefully and then install two “AAA” Alkaline batteries according to the (+/-) polarity. Press the “power switch” key for 1 second to activate the device. All icons appear on the LED screen. The device is then in the “self-test” mode with the software version shown.The measurement starts at the completion of the “self-test.” The pulse bar with “-“ icon on the screen up and down means the measurement result will be ready soon. The readings of oxygen saturation, pulse rate, and pulse strength will appear on LED screen in 8 seconds average. If the measurement fails, the icon “- -“ will appear on LED screen. The device will turn itself off automatically after 8-second idling. While the battery power is low, the LED icon will flash twice per second. Please replace the batteries as soon as possible or the device will be off automatically in 30 seconds.  6.  Specifications  6.1 Performance Scope of measurement: SpO2: 35% - 99% Pulse rate: 30-250 bpm (beats per minute) Precision: SpO2: 70%-99% : ±2%, 35% - 69%: unspecified Pulse rate: 30-250 ± 3 bpm 6.2 Electrical specifications Battery (2 “AAA” Alkaline batteries) Battery capability: Can be used for 16 hours continuously depending on the type of battery used. 6.3 Environmental conditions Operating temperature 5℃ - 40℃ (41℉ – 104℉) Storage temperature: -20℃ - 70℃ (-4℉ – 158℉) Relative humidity: 15% -95% (no condensing) 6.4 Physical characteristics Weight: 37g (excluding battery) Size: 63.5 x 34 x 35 mm 6.5 Standards IEC60601-1-2, Class B,IEC60601-1, Type BF ISO 9919: 2005 6.6 Markings Type BF (Body Floating) Drip proof ATTENTION Read instructions for use before use.  7.  Problem shooting and maintenance  7.1 Dysfunction and resolution Low battery-Please replace the battery Switch On failure Check the power of battery  Check the placement of battery  Return to manufacturer for calibration 7.2 Cleaning Surface cleanings is by using a soft cloth dampened with either a commercial, non-abrasive cleaner or a solution of 70% isopropyl alcohol in water, and lightly wiping the surfaces of the oximeter.  Please switch off pulse oximeter before cleaning. Clean the LED and photo-sensor with moist cloth or cotton ball and alcohol gently. The aforementioned general cleaning process is not for infection prevention. Please contact the specialist for the process of contagious infection. 7.3 Disposal Used batteries should not be disposed of in the household rubbish. Batteries should be deposited at a collection point for used batteries. At the end of its life, the appliance should not be disposed of in household rubbish. Enquire about the options for environment-friendly and appropriate disposal. Take into account local regulations. 7.4 Electromagnetic interference Caution: This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2 and MDD 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare environments (for example, electrosurgical units, cellular phones, mobile two-way radios, electrical appliances, and high-definition television), it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device. This Fingertip pulse oximeter is not designed for use in environments in which the pulse can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the monitor may not seem to operate correctly.  8.  Warranty  The company warrants pulse oximeter at the time of its original purchase and for the subsequence time period of one year. The warranty does not cover the followings:  The device series number label is torn off or cannot be recognized.  Damage to the device resulting from misconnection with other devices.  Damage to the device resulting from accidents.  Changes performed by users without the prior written authorization of the company.  Rossmax InnoTek Corp. 12F, No. 189, Kang Chien Rd., Taipei 114, Taiwan Tel: + 886-2-2659-7888 Fax: + 886-2-2659-7666 www.rossmaxhealth.com  Date of manufacture Used batteries should not be disposed of in the household rubbish. Batteries should be deposited at a collection point for used batteries. At the end of its life, the appliance should not be disposed of in household rubbish. Enquire about the options for environment-friendly and appropriate disposal. Take into account local regulations. Alarm function is off Complies with the European Medical Device Directive 93/42/EEC  The text is subject to change without further notice. August, 2008  IBP innovative business promotion GmbH Botzstrasse 6, D-07743 Jena, Germany
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