Wrist Pulse Oximeter MD300W628 INSTRUCTION MANUAL
Copyright Our company owns all rights to this unpublished work and intends to maintain this work as confidential. Our company may also seek to maintain this work as an unpublished copyright. This publication is to be used solely for the purpose of reference, operation, maintenance or repair of our equipment. No part of this can be disseminated for other purposes.
CONTENT 1 Introduction..........................................................................................................................................1 1.1 Brief Introduction....................................................................................................................................................... 1 1.2 Safety Information.....................................................................................................................................................
Settings...............................................................................................................................................18 4.1 Indication Setting..................................................................................................................................................... 18 4.2 Date Management................................................................................................................................................... 20 4.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 1 Introduction 1.1 Brief Introduction Thank you for purchasing MD300W628 Wrist Pulse Oximeter. The main functions of the device include hemoglobin oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI) measurements, visual and audible indication, data storage and transmission through Bluetooth®. Please read this manual carefully before using the device. Note: The illustrations applied in the manual may differ slightly from the actual device.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Warnings! • Before use, carefully read the manual. • The wrist pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. • The wrist pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL is being used to oximeter a patient. • Products contain small parts; Keep the equipment away from children and pets. • This equipment may cause allergy. • This equipment is not intended for use during patient transport outside the healthcare facility. • Do not use the wrist pulse oximeter in an MRI or CT environment.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL being damaged, and to protect user under safety situation. • The wrist pulse oximeter is a precision electronic instrument. It must be repaired by trained personnel only. • Ensure that the wrist strap fits comfortably on the patient’s arm. Do not over-tighten the wrist strap. • This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equipment and/or systems.
MD300W628 • WRIST PULSE OXIMETER INSTRUCTION MANUAL Application of this device in the background of electromagnetic areas may influence the measuring accuracy such as in the environment of electro-surgery. • SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the probe area (with a surgical towel, for example) if necessary. • Significant levels of dysfunctional hemoglobin may affect the accuracy of the measurement.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL qualified technical personnel authorized by our company. • As to the other concerns for attention, please carefully look through the specific chapter in this instruction. • This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: this device may not cause harmful interference and this device must accept any interference received, including interference that may cause undesired operation.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL This apparatus complies with the IEC 60601-1-2 international standard. The requirements of this international standard are: CISPR11, GROP1, and CLASS B. 1.5 Explanation of Symbols Symbol %SpO2 Meaning Symbol PR Hemoglobin Oxygen Saturation IP33 Type BF applied part Attention, consult the accompanying documents.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 1.6 Product Features Compact in design, easy to wear; Touch screen, simple operation; Data storage, bluetooth transmission; Abnormal data, vibration reminder.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 2 General Description The wrist pulse oximeter adopts OLED touch screen, which can display the SpO2, PR and PI value. It can also provide information of date and time, remind you of the connection of Bluetooth®, probe or finger as well as record your walk steps. 2.1 Appearance Fig.2-1 Description of Fig.2-1: 1: OLED touch screen: display SpO2, PR and PI values, date & time, battery power, Bluetooth® connection.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL turn on or off the screen when the device is powered on. 4: The probe socket/charging interface: to connect SpO2 probe for measurement and connect USB cable for battery charging. 2.2 Power Supply The MD300W628 wrist pulse oximeter is powered by lithium-ion rechargeable battery. The battery will typically work for 10 hours in sleeping mode with the screen off.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Notes: Keep the device and power adapter away from source of fire and/or heat; Do not touch the power adapter with your wet hands; The battery is not a detachable part, do not attempt to disassemble it; Charge the battery using specified chargers; Do not use the battery and power adapter in un-specified application.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 3 Take a Measurement 3.1 Power On Press and hold "Power button" for 3±1s to start up the device. The display screen will be highlighted when powered on (see Fig.3-1). Then the screen will show a time and a date (see Fig.3-2). Swipping the screen left and right to switch the interfaces. Fig.3-1 Fig.3-2 3.2 Probe Installation 1.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 2. Place the patient’s finger inside the sensor as shown in Fig.3-4. Fig.3-4 3.3 Take a Measurement i Swipe the creen left to enter the measurement interface, as the Fig.3-5, the values will be horizontal lines "-" before the results show. Fig.3-5 ii Then the measurement result will display as in Fig.3-6.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL from the screen. Swipe the creen left, you can check your walk steps, see Fig.3-7 Fig.3-6 Fig.3-7 Description of measurement screen: 98 : %SpO2 value 79 : PR value 3.6 : PI value : Pulse waveform : Battery power indication. A low battery indication may be displayed, when the remaining power capability is insufficient. The device will automatically shut down when the battery voltage is lower than 3.5V + 0.1V.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL If the probe is inserted into the pulse oximeter but no finger is placed, “Finger Out” will appear on the screen (Fig.3-8). If there is no probe inserted after power on, “Probe Off” will appear on the screen (Fig.3-9). Fig.3-8 Fig.3-9 iii Switch measuring modes: The device will default to real-time measurement each time you power it on. Swipe down from the top on any screen and tap on the screen as shown in Fig.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL During operation, the accuracy of oximetry readings can be affected by the following factors: (1) Instrument performance depends on the pulsatile character of the artery. The measurement would not be considered reliable and accurate if the following conditions take place during measurement.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL catheter, or intravascular line; c) The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia; d) An arterial occlusion proximal to the sensor. Warnings! Do not use an SpO2 sensor with exposed optical components. Excessive patient movement may cause inaccurate measurements. Tissue damage can be caused by incorrect operation or misusing sensor; for example, by wrapping the sensor too tight.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 4 Settings Firstly, power the device on and swipe the screen right to enter the setting menu, shown as in Fig.4-1. Fig.4-1 4.1 Indication Setting Tap "Indication Setting" from the menu (see Fig.4-1) to enter its sub setting interface, shown as follow: Fig.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 4.1.1 Tap "Indication Switch" and on the next screen tap the ON or OFF button the enable or disable the indication of SpO2 or PR, as shown in Fig.4-3. Fig.4-3 Indication on: When there is special case happens, the device will prompt the user by vibration. Indication off: The vibration indication will be closed. Please be careful with this setting. 4.1.2 Tap "Indication Limit Setting" you can set the indication limits of SpO2 (Fig.4-4) and PR (Fig.4-5).
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Note: • The set range of SpO2 is 70%－100%. • The set range of PR is 30bpm－250bpm. • The high limit you set should be greater than that of the low limit of the same parameter. • When the measurement results are out of the indication limits you set, the device will prompt the user by vibration. 4.1.3 Tap "Indication Pause". The screen will display as in Fig.4-6, tap the figure to set the pause time between "60s", "120s" and "180s". Fig.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL • Tap "Delete Data" and then select "√" to detele all data. Select "X" to cancel the move and return. • Tap "Data review" to check record data under sleeping mode. 4.3 System Setting Fig.4-7 Tap "System Setting" from he main setting menu (see Fig.4-1) to set the device date and time. Tap "Date and Time" on submenu, see Fig.4-8 to set the date first and then swipe the creen left to set the time: tap and hold the figure on the screen, see Fig.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL . Fig.4-9 4.4 Other settings Swipe down from the top on any screen, see Fig.3-10. Tap to enable Bluetooth® function or not. Tap to enable indication function or not. Tap to enter sleeping mode. indicates the remaining power.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 5 Troubleshooting Problems Possible reasons 1. Finger is not inserted correctly SpO2 or PR can not 2. Patient’s SpO2 value is too low to be be shown normally measured 3. Probe malfunction SpO2 or PR is shown unstably 1. Finger might not be inserted deep enough. 2. Excessive patient movement Solutions 1. Retry by inserting the finger 2. There is excessive illumination 3. Change the probe 4. Try some more times.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 6 Maintenance and Repairs 6.1 Maintenance Use only the substances approved by us and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s Infection Control Officer or Epidemiologist.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL oximeter is repaired or upgraded, a thorough inspection should be performed by qualified service personnel to ensure the reliability. Follow these guidelines when inspecting the equipment: Make sure that the environment and power supply meet the requirements. Inspect the equipment and its accessories for mechanical damage. Make sure that only specified accessories are applied. Inspect if the cautionary system functions correctly.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Ethanol (70%) Isopropanol (70%) To clean your equipment, follow these rules: 1. Shut down the pulse oximeter. 2. Clean the display screen using a soft, clean cloth dampened with a glass cleaner. 3. Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner. 4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary. 5. Dry your equipment in a ventilated, cool place.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Note: The simulator cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter. 6.3.1 Control Key Verification Press Menu key, display the analysis results. 6.3.2 SpO2 & Pulse Rate Measurement Value Verification a)．Connect SpO2 Probe to the SpO2 connector on the oximeter.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Field inspecting: we will send engineers to repair the instrument if necessary. Certified engineers of our company or local repair team trained by our company provide this service. Fittings replacement: if necessary, we will replace the damaged fittings according to contract. The damaged fittings should be returned to us expect for special reason.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL that are not provided by our company are not covered by the warranty. d）Responsibility limitation In the duration of warranty, if user changes the parts manufactured by other manufacturers without our company permission, our company is entitled to cancel contract. 6.4.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL surface of the instrument. The circuit is short and damaged due to liquor or other stuff flow in the instrument or its fittings. All probe and its accessories are not free replacement. If any code label of parts is damaged or missing, this warranty shall become null and void. For example of code label. Such damage of probe caused by mechanical force doesn’t belong to free change range.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Please offer guarantee list and copy of invoice to standby with the period of guarantee. Please describe failure phenomenon in detail and altogether offer oximeter. Storage and Transportation Storage: Storage Temperature -20°C～55°C, Relative Humidity ≤93%, no condensation. Transportation: Transport by airline, train or vessel after packing according to request.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL 7 FCC Declaration Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Appendix A Specifications Notes: Specifications may be changed without prior notice. The circuit diagrams, the list of components, the illustrations of diagrams, and the detailed rules of calibration are provided exclusively to professional personnel authorized by our company. Display TYPE: OLED Parameters: %SpO2, PR, PI, PR waveform SpO2 Display range: 7%~100% Measurement range: 70%~100% Resolution: 1% Accuracy: 70%~100%: ±2%; <69%: unspecified.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Measurement range: 30~250bpm Resolution: 1bpm Accuracy: 30~99bpm, ±2bpm; 100~250bpm, ±2% PI Display range: 0.1~20.0% Measurement range: 0.3~20.0% Resolution: 0.1% Accuracy: 0.3~1.0% (±0.2digits); 1.1~20.0% (±20%) Power Supply Lithium-ion rechargeable battery DC 3.7V Power Adapter Input Voltage: AC 100~240V Input Frequency: 50~60Hz Output Voltage: DC 5V Output Current: 1,000mA (MAX) Bluetooth® Working Distance: 10m Bluetooth® 5.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Operation Environment Operating Temperature: 5℃~40℃ Ambient Humidity: 15%~93%, no condensation Atmosphere Pressure: 70kPa~106kPa Storage and Transportation Environment Storage Temperature: -25℃~70℃ Ambient Humidity: ≤93% no condensation Atmosphere Pressure: 70kPa~106kPa Outline Dimension: 44X38X13±2 mm (Length X Width X Height) Weight: 25±5g (without battery) Classification According to the type of protection against electric shock: INTERNALLY POWERED EQUI
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Appendix B Declaration Table 1 Guidance and Manufacturer’s declaration – electromagnetic emissions-For all EQUIPMENT and SYSTEMS Guidance and Manufacturer’s declaration - electromagnetic emission The MD300W628 Wrist Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of MD300W628 Wrist Pulse Oximeter should assure that it is used in such an environment.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Table 2 Guidance and Manufacturer’s declaration – electromagnetic immunity-For all EQUIPMENT and SYSTEMS Guidance and Manufacturer’s declaration - electromagnetic immunity The MD300W628 Wrist Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the MD300W628 Wrist Pulse Oximeter should assure that it is used in such an environment.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Portable and mobile RF communications equipment should be used no closer to any part of the Wrist Pulse Oximeter (MD300W628), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 10 V/m d=0.35√P 80 MHz to 800 MHz 80 MHz to d=0.7√P 800 MHz to 2.5 GHz Radiated RF 2.
MD300W628 WRIST PULSE OXIMETER INSTRUCTION MANUAL Table 4 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMS - For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and Wrist Pulse Oximeter (MD300W628) The Wrist Pulse Oximeter (MD300W628) is intended for use in electromagnetic environment in which radiated RF disturbances are controlled.
