Pulse oximeter W01T
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SONOSAT-W Series Wrist Pulse Oximeter User Manual P/N: 1.28.0016-14 Version: 1.4 Release/Revision date: July, 2018 Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd In some circumstances, the device may interpret motion as good pulse quality. Minimize patient motion as much as possible. 9 High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. 10 Charge this equipment only by connecting it to a designated device compliant with electrical safety requirements and ensure the designated device’s voltage and current meet the requirements of this Manual. 11 Do not connect it to any external device or operate it for parameter measurement when this equipment is being charged. 12 Do not use this device in situations where alarms required. This oximeter does not support alarms. 8 Thanks for you purchasing wrist pulse oximeter of Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd (hereinafter called Konsung). Before using this oximeter, please read this manual carefully for understanding the operation and maintenance of the oximeter. Konsung holds the rights to modify, update, and ultimately explain this manual. Konsung owns the copyrights of this manual. Without prior written consent of Konsung, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which Konsung cannot be held liable. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your measuring system. Konsung only considers itself responsible for any effect on safety, reliability and performance of the equipment if:  Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Konsung, and  The electrical installation of the relevant room complies with national standards, and  The instrument is used in accordance with the instructions for use. Upon request, Konsung may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which Konsung may define as user serviceable. The user should pay attention to and abide by the basic safety information which was referred to in this chapter.  A WARNING label advises against certain actions or situations that could result in personal injury or death. 1 To ensure user’s safety, use only parts and accessories specified in this manual. 2 Follow local governing ordinances and recycling instructions regarding disposal or recycling of the device and device components. 3 Do not use this device near by the source of electromagnetic interference, such as mobile phones or radio transmitter. 4 Please keep the device surface dry and clean. Keep the device away from corrosive chemicals, dust, high temperature and humidity environment. 5 The environment temperature should be guaranteed (working temperature: 5°C to 40°C, transport and storage temperature: 20°C to +60°C). 6 This device should be appropriately placed. Keep it from falling, strong vibration, or other mechanical damage. Make sure the nail covers the light window. The wire should be on the backside of the hand. Avoid placing the sensor on extreme cold finger. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. The SpO2 waveform is disproportionate to pulse. Do not use this equipment on any limb with arterial cannula, intravenous infusion set or inflated blood pressure cuff. Do not use any function tester to measure the SpO2 accuracy. The device was calibrated. Display arterial oxygen saturation (SpO2) and pulse rate (PR). If the detected signal is incomplete, the equipment will not display the parameter value but display the waveform as a straight line. The pictures and interfaces in this manual are for reference only This Manual is prepared based on the most complete configuration. Some configurations and functions may be not available in your equipment. 1.2 Symbols Symbols Definition of symbols Follow instructions for use  A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE  A NOTE provides useful information regarding a function or a procedure. Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd No.8, Shengchang West Road, Danyang Economy Development Zone, Jiangsu Province, China Post: 212300 Tel: +86-511-86375968 Fax: +86-511-86371668 E-mail: info@ konsung.com Website: www.konsung.com Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg Germany Tel: +49-40-2513175 Fax: +49-40-255726 E-mail: shholding@hotmail.com This device is a small, lightweight, portable device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR). The device measures the patient’s SpO2 and PR with a SpO2 senor. The measurements display on the screen after certain further processing. Follow the following steps to operate the oximeter. 1. Wear the oximeter on your wrist. 2. Connect the probe to the oximeter's USB interface, the probe sensor works, and emits red light. 3. Insert your finger into the probe's fingertip (fully insert your finger and make sure the probe sensor shines on the nail for better measurement), as shown below. Intended use: The Wrist Pulse Oximeter intended to be used for home care and medical outpatient measure pulse oxygen saturation and pulse rate of adults and pediatrics. Structure and composition: This equipment mainly composed of the motherboard, SpO2 transducer and built-in battery. There are several type of Wrist Pulse Oximeter, refer to below chart for specifications. Model SONOSAT-W01T SONOSAT-W01W SONOSAT-W01P SONOSAT-W01LT SONOSAT-W01LW SONOSAT-W01LP Screen display and description Display Description Blood oxygen saturation Pulse rate Battery capacity System time Note: The finger should be placed in the fingertip during working status of the probe sensor (lights red). If the probe sensor does not light red, you need to unplug the probe and re-connect it to the oximeter. Authorized representative in the European community Serial Number Part Number Manufacturer Date of manufacture 2 degree Protection Against Ingress of Liquids and dust. 4. Press the function key to switch the oximeter to the measurement display, and the oximeter starts the measurement. 5. The oxygen saturation and pulse rate values are displayed on the screen. 1 Do not use the oximeter for measurement when the oximeter is in charge. 2 Do not shake fingers during measuring. Do not move your body and keep quite. 3 Inspect the sensor site every two or three hours and make sure that the good measurement site and sensor applied properly. Move the sensor to another site if the skin quality changes. Change the application site every four hours. The system time setting, the measurement reminder time setting, the walking steps function, and device settings such as screen lighting time, alarm setting and parameter alarm limit setting of the oximeter should be used with the mobile APP software. This manual does not describe these operations in detail. The following factors may influence the accuracy of measurement:  Ambient light  Physical movement (passive and imposed motion)  Diagnostic testing  Low perfusion  Electromagnetic interference, such as MRI environment  Electrosurgical units  Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin (MetHb)  Presence of certain dyes, such as methylene and indigo carmine  Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor.  Drop of arterial blood flow to immeasurable level caused by shock, anemia, low temperature or vasoconstrictor. Chapter 5 Charging Battery Pulse Rate The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. 1. Wrist belt 2. Switch button  Press this button to switch the display interface (measuring, time, step counter, battery indicator).  Press and hold this button for 3 seconds, the screen display will change its display direction.  Press and hold this button for 6 seconds to turn off the oximeter. 3. Display screen 4. SpO2 probe connector 5. USB interface  Connect SpO2 probe  Connect the USB charging cable 6. Probe finger sleeve Oxygen saturation of arterial hemoglobin The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Type BF Applied Part Battery Lithium Lithium Lithium Lithium Lithium Lithium This equipment is not intended for treatment. Ensure that the equipment is in normal working condition and operating environment before using. Carefully read this manual about all safety information, operation and specifications before using this oximeter. Do not open the shell of instrument; otherwise you may damage the instrument. Only the authorized trained maintenance engineers are allowed to repair or upgrade this equipment. Any modification unauthorized will lead to data inaccurate or even damage of device. Do not use this device with the defibrillator or other high-frequency equipment. Explosion hazard: Do not use this device in an explosive atmosphere. It is recommended to check the applied finger during the measurement. Change other finger to be measured if the finger seems to be unusual. The oximeter is intended only as an adjunct in patient assessment. It must be used with other methods of assessing clinical signs and symptoms. It is not intended as a device used for treatment purposes. Chapter 4 Measurement operation Contraindication: none Chapter 3 Unpacking and Storage 3.1 Open-case inspection Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or us. Take out all bulk packaging from the carton. If the packing case is intact, open the package and remove the equipment and accessories carefully. Check whether there is any damage to the surface of the oximeter such as notches, dents, abrasions and so on. Check whether the components are missing according to packing list. The oximeter is manufactured with precision parts. Do not place the oximeter in the following places:  Easy to splash;  With Direct sunlight, high temperature, humidity, dust, and corrosive gas;  Tilt, generate vibration and impact;  Store chemicals or corrosive gases. The oximeter uses a built-in non-removable rechargeable lithium battery. Symbol will flash when battery capacity is low. Charge the battery according to the following steps. 1. Connect the adaptor connector into the Mini USB connector of oximeter. 2. Connect the adaptor into socket to charge the oximeter (the battery charging icon displays on the screen). The performance of the rechargeable lithium battery may deteriorate over time. If the operating time of the battery is noticeably shorter than that stated in the specifications, contact your service personnel. Follow the appropriate local regulations and do not dispose of oximeter (includes battery).