Operation Manual of Pulse Oximeter Note Read this manual carefully for correct operation before using the Pulse Oximeter. Keep the manual properly for reference at any time when necessary. Product Name: Pulse Oximeter Specification and model: OX201 Product structure and component: the equipment is composed of host, battery and display screen. Dongguan Lingxin Technology Co., LTD Address: Room 301,No.3 Liantang Road,aoshitang,Dongcheng Street,Dongguan City,Guangdong Province,China.
Table of Content 1 Safety Information ............................................................................................................ 3 1.1 Safety Information ..................................................................................................... 3 1.2 Symbol of Equipment ................................................................................................ 5 2 Overview ......................................................................................................
6.1 Cleaning and Disinfection ........................................................................................ 16 6.2 Maintenance ............................................................................................................ 17 6.3 Troubleshooting....................................................................................................... 17 7 Accessories ....................................................................................................................
(8) Do not use the equipment under the application conditions beyond its declared specification scope. (9) When using the equipment for long-term continuous monitoring, check and replace measured parts at least every 2 hours. It is necessary for more frequent examinations in some scenarios, such as perfusion disorders and skin sensitivity. Prolonged monitoring may increase unpredictable skin changes, such as allergies, reddening, blistering, or compressive necrosis.
(30) Please read the measured value when the waveform on screen is equably and steady-going, This measured value is optimal value. (31) If some abnormal conditions appear on the screen during test process, pull out the fingerand reinsert to restore normal use. (32) The device has normal useful life for three years since the first electrified use.
Keep dry This side up Range of storage temperature Stacking level Range of storage humidity Range of atmospheric pressure Complies with the European Medical Device Directive (93/42/EEC and amended Disposal in accordance with Directive Directive 2007/47/EC. 2002/96/EC (WEEE) Notified Body is SGS Belgium NV Authorized representative in the European Community. The European representative Batch and serial number is: Shanghai International Holding Corp.
The Pulse Oximeter has been calibrated to show functional blood oxygen saturation. The plethysmography waveform and parameter value will be displayed on the screen. Figure 1 Schematic Diagram of Working Principle 2.1.2 Scope of Application This equipment is used to measure blood oxygen saturation and pulse rate of patients. It is expected to used by medical institutions, health care institutions or individuals. And it is suitable for adults and children 2.1.3 Contraindications No contraindications 2.
1 1．Battery compartment: two AAA batteries. 2.2.2 Side View 2 1 1．Hole of rope: to tie role. 2．Cavity of finger clip: place finger in this cavity to measure blood oxygen saturation. 2.3 Product Display 2.3.1 OX201 Display Screen 1 3 6 5 8 7 11 2 9 10 4 1．Unit of blood oxygen saturation: SpO2% 2．Measured value of blood oxygen saturation: the display range is [1 ~ 100] and the sign “---” means invalid value.
．Bar chart: showing the instantaneous state of blood pulse which is proportional to pulse intensity. 10．Tracing wave: display physiological pulse waveform, and non normalized processing. 11．Battery capacity: the indicator’s lighting length varies with remaining battery capacity. 3 Basic Operation 3.1 Installment 3.1.1 Battery Installment Fig. 2 Schematic Diagram of Battery Installment 1. Ensure the polarity of two AAA batteries in consistent with the polarity mark in the battery compartment; 2.
3.1.2 Tie rope Fig. 2 Schematic Diagram of Rope 1. Put the thin end of the rope through the hanging hole. 2. Put the thicker end of the role through the thin end. 3. Tighten the rope. 3.2 ON/OFF Turn On: after installing batteries, press ON/OFF Button to turn on the equipment. Enter into the measurement interface after the system starts. If the Pulse Oximeter does not detect the finger within 8 seconds, it will automatically shut down. 4 Measurement 4.
Display screen Fig. 4 Diagram to Wear Equipment 4.3 Measurement Precautions (1) Please check the device before using, and confirm that it can work normally. (2) The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’ sarteriole in a position there between. (3) The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection.
4.4 Bluetooth and APP 4.4.1 Download instructions 1.Scan the code and install the app, as shown in the figure below. 2.Open the download link at https://www.pgyer.com/spo2? Sign=& auSign=& Code = Download mobile APP-NargMed. 4.4.2 Operation interface description 1.Click the“connect to device” button. Then switch to the measurement interface. 1. Unit of blood oxygen saturation: SpO2%。 2. Measured value of blood oxygen saturation: the display range is [1 ~ 100] and the sign “---” means invalid value。 3.
6. Measured value of perfusion index: the display range is [0.02 ~ 20.0]and the sign “---” means invalid value.。 7. Home。 2. Click the“History” button. Then switch to the historical data view interface. 1. Unit of blood oxygen saturation: SpO2% 2. SpO2 historical data. Swipe left and right to view historical data. 3. Unit of pulse rate: PR/min 4. PR historical data. Swipe left and right to view historical data. 5. Unit of respiratory rate: RR / min 6. RR historical data.
1. Historical oxygen drop events：Hypoxemia and Insufficient blood perfusion 2. Time of event 3.
3. The parameters of the oximeter can be set through the following menu. 1. Patient type setting. Including: adult children 2. Response speed setting. Including: Rapid，Normal，slow 3. Sensitivity setting. Including: low，Middle，High. 4. Delete all Historical Data 5. Device search list 5 Product Specification 5.1 Specification of host 1．The product uses internal power supply.
11．Parameters of LED light source 12．Data shall be refreshed within two seconds. The average time of data is set in accordance with 3.5.7 and data in set average time will be selected and averaged. Light Source Central Wavelength Radiant Power Red light 660nm <15mW Infrared light 905nm <15mW 5.
2. Shut down the equipment and take out batteries. 3. Clean the silica gel (inside face of the Pulse Oximeter, that can be contacted by finger when normal use) by wetting a small piece of cloth with isopropyl alcohol---75% medical alcohol. 4. Then to dry the Pulse Oximeter with a dry, soft cloth. 6.2 Maintenance The design life of the product is 3 years. Please maintain the equipment as follows: 1. Clean and disinfect the equipment according to this instruction before using. 2.
7 Accessories 1. One pulse Pulse Oximeter 2. Two batteries（optional） 3. One manual 8 EMC Specification The instructions for use shall include the following: 1： (a statement of the environments for which the Pulse oximeter is suitable. Relevant exclusions, as determined by RISK ANALYSIS, shall also be listed, e.g. hospitals except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS Guidance and manufacturer´s declaration – electromagnetic emission The Pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of Pulse oximeter should assure that it is used in such an environment.
Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacturer´s declaration – electromagnetic immunity The Pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse oximeter should assure that it is used in such an environment.
NOTE UT is the a. c. mains voltage prior to application of the test level. Guidance and manufacturer´s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEM Guidance and manufacturer´s declaration – electromagnetic immunity The Pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse oximeter should assure that it is used in such an environment.
recommended separation distance in metres (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS Recommended separation distances between portable and mobile RF communications equipment and the Pulse oximeter The Pulse oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
10 3.8 6.32 1.10 2.21 100 12 20.00 35 70 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
