HAND HELD PULSE OXIMETER INSTRUCTION MANUAL Reorder No.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 2
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL All information contained in this publication is believed to be correct. We shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. The information this publication refers to is protected by copyrights or patents and does not convey any license under the patent rights of our company, nor the rights of others.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Contents 1 Introduction...................................................................................... 6 1.1 Brief Introduction........................................................... 6 1.2 Safety Information ......................................................... 6 1.3 Equipment Symbols .....................................................11 1.4 Equipment Classification ........................................... 12 1.5 Package Contents.......
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 6 History Data Reviewing ............................................................. 26 6.1 Character Definition.................................................... 26 6.2 Reviewing Operation.................................................. 26 7 Alarm Setting ................................................................................ 27 7.1 Alarm Priority................................................................. 27 7.2 Character Definition..
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 1 Introduction 1.1 Brief Introduction Thank you for purchasing the Hand Held Pulse Oximeter. The device is designed to measure SpO2 and PR, delivering visual and audio alarm, sensor off alarm, data storage and review etc. Please read this manual carefully before using it. 1.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL hazard may exist. All servicing and future upgrades must be carried out by trained personnel and authorized by our company only. • The Pulse Oximeter is specified for use by medical professionals only. • Prolonged use of the probe/sensor or the patient’s condition may require changing the sensor site periodically. Change the sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring. • Worn-out data cables may also cause inaccurate data, so if the data is used as a reference to treat a patient, pay special attention to the data cable and check it more frequently. • When using the equipment with electrosurgical units (ESU), make sure the patient is safe.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL EMC requirements. Mobile phones, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. • Unplug the sensor from the Oximeter before cleaning or disinfecting it. If liquid is accidentally spilled on the unit, clean and dry thoroughly before reuse. • Do not try to use the SpO2 and NIBP measurement on the same arm at the same time. This could potentially affect measurement accuracy.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL • Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein, may influence the accuracy of the SpO2 reading. •A ny condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause a failure to determine accurate pulse rate and SpO2 readings. • Remove fingernail polish or artificial fingernails before applying SpO2 sensors.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 1.3 Equipment Symbols Symbols Definitions Attention! Refer to the relevant information. Read operator’s manual carefully before using the Oximeter.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 1.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 2 General Descriptions The Hand Held Pulse Oximeter has 8-segment digital LED for displaying data. It can display the SpO2 and pulse rate value, time & date, ID number, pulse bar as well as battery status etc. 2.1 Front Panel Please refer to Fig. 1. The display in Fig. 1 is a normal screen. Fig. 1 Front panel Instruction of Fig. 1: 1. SpO2: SpO2 value 2.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 3. Low power indicator. When the power is lower than 2.4V, the lamp indicated will be lighted, and the Oximeter will power off automatically when the power is lower than 2.3V. 4. Alarm Indicator: When technical alarm or physiological alarm occurs, the lamp indicated will turn red. 5. Power button 6. Navigation buttons: you can select and set the different parameters.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 2.2 Rear Panel Fig. 2 Rear panel Rear panel introduction: 1. Battery compartment – Uses 2 AA-size alkaline batteries (not included) 2. Fixing hole 3. Fixing screw 4.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Battery Installation (Batteries Not Included): 1) Open the battery cover: Rotate the fixing screw slightly in the rear panel to the up position which is marked with “ “ and then open the cover. 2) Install 2 batteries as indicated by the polarity sign. Note: Be sure to insert the batteries in the correct polarity, as indicated by polarity markings (+ and -) inside the battery cover.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL t Do not insert the batteries with the polarities in the wrong direction. t Do not dispose of batteries in fire. t If battery contents should get on your skin or clothing, immediately rinse with plenty of clean water. t Remove the batteries from this unit when you are not going to use it for a long period of time (approximately three months or more). t Do not use batteries of different types together. t Do not use new and used batteries together.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 3. Getting Started 3.1 Unpacking and Checking Before unpacking, examine the packing case carefully for damage. If any damage is detected, contact your distributor. Open the package and remove the equipment and accessories carefully. Check all materials as per the packing list and check for any mechanical damage. NOTE Save the packing case and packaging material as they can be used if the equipment must be reshipped.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Warning: Make sure that the operating environment of the equipment meets the specific requirements. The equipment may not meet the specifications defined in this manual and unexpected consequences, e.g. may result in damage to the equipment 3.3 Connect The Sensor 1. Before use, check the Pulse Oximeter for mechanical damage. 2. Install the alkaline batteries and ensure that the batteries have sufficient power. 3.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 3.4 Starting or Shutting Off the Oximeter To start the Pulse Oximeter: 1. Press and hold the Power button for about 3 seconds. The LED and alarm lamp flashes, and then goes out. The system gives a beep and displays the startup screen. The startup screen displays the version number of software. 2. The startup screen disappears and normal screen appears. To shut off the Pulse Oximeter: 1. Confirm that the patient measurement is finished. 2.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL before using the unit. Reset them if necessary. The date and time are important indicators when a measurement is taken. 4.1 Date & Time Setting Press the menu button four times under the screen to enter time setup. Character Definitions: : Is the minute. The setting range is: 0-59 : Is the hour. The setting range is: 0-23 : Is the date. The setting range is: 1-31 : Is the month. The setting range is: 1-12 : Is the year.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 4.2 ID Number Setting 1. After powering on, hit the menu button two times. You can enter into the ID setting screen. Press the up or down button to set the ID number and then press the menu button to confirm your setting. It will turn to the normal screen if there is no button pressed for 10 seconds. The setting range of ID number is: 1-99. 2. In normal screen, press the up button, the digital LED shows the current ID number.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL After finishing the time and the ID number setting, plug your finger into the sensor as indicated in the picture below: Fig. 6 placement of the sensor Select the suitable sensor in terms of type and dimension. Clip the sensor in the right position of the patient finger and ensure that the patient’s nail surface is facing upward. Plug sensor into SpO2 port on top panel of Pulse Oximeter. Fig.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 5.1.1 Instrument performance depends on the pulsatile character of the artery. The display would not be considered reliable and accurate if the following conditions are present during measurement. • Shock or cardiac arrest • Temperature of the unit • After the administration of a cardiovascular drug • Anemia • Evidence of ventilation-perfusion mismatch 5.1.2 Instrument performance depends on the wavelength absorption for oxyhemoglobin and deoxyhemoglobin.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 5.1.4 Other factors a) High-frequency electrosurgical interference from external devices, including defibrillators. b) Placement of a sensor on an extremity that currently has installed a blood pressure cuff, arterial catheter, or intravascular line; c) The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia; d) An arterial occlusion proximal to the sensor. WARNING! • Use only SpO2 sensors provided by manufacturer.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL NOTES: ulse sensor should obviate the light source, e.g. radial P lamp or infrared lamp. S et the upper limit of SpO2 alarm to 100% means cut off the upper alarm. High density of oxygen will cause adverse affection to the neonate. So the upper limit of SpO2 alarm must be selected prudently according to the 6 History Data Reviewing. 6 History Data Reviewing 6.1 Character Definition: : The user’s SpO2. : The user’s pulse rate. : The user’s ID number.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL By the right or down button, you can review the next or last group of measured data. If ”S” displays on the screen after pressing the left button continuously, it means the last group is the newly measured data. And, if “E” displays on the screen after pressing the right button continuously, it means the last group is the previous measured data . 7 Alarm Setting 7.1 Alarm Priority There are three-level priorities for selection.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Audible Alarm Indicators: Audible alarms can be heard in a quiet environment. The audible alarm has different tone pitch and on-off beep patterns for each alarm priority. • High priority: SpO2 alarm “du-du-du ---------- du-du”, beeps every 8 seconds. • Medium priority: PR alarm “du-du-du”. beeps every 8 seconds. • Low priority: Sensor off or finger out “du-”, beeps every 20 seconds. 7.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL SpO2 Low alarm: After finishing the high alarm setting, press the right button and you will see on the screen the low alarm of SpO2 setting (refer to Fig. 10). Press the up or down button to adjust the number. The low alarm (SpO2) setting range is 70-99(%). Fig. 10 7.4 PR Alarm Setting: After SpO2 low alarm setting, press the right button, and you will see the screen shown as Fig. 11 for setting PR high alarm.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Fig. 14 Fig. 13 7.6 Alarm Activation Alarm will be activated with the following conditions: Physiological alarm: • The alarm will work when the SpO2 value or pulse rate gets beyond the high-limit or goes below the low-limit. The difference is their priority; the SpO2 has the high priority while the pulse rate has the medium. • Technical alarm (error code): a) Error Definitions E 1: Program memory is damaged. E 2: Data memory is damaged.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL E 9: The SpO2 value is lower than the low limit. E 10: The SpO2 value is higher than the high limit. E 11: The value of pulse rate is lower than the low limit. E 12: The value of pulse rate is higher than the high limit. E 13: Power supply is insufficient. When E9, E10, E11 or E12 occurs, the value of parameter will flash. • Check the error code. • Press the right key under normal screen, it will indicate an error code.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 9 Maintain and Cleaning Use only the substances approved 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 methods to control infection, consult your hospital’s Infection Control Officer or Epidemiologist.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL is repaired or upgraded, a thorough inspection should be performed by qualified service personnel to ensure its 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 alarm system functions correctly.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL • Hydrogen peroxide (3%) • Ethanol (70%) • Isopropanol (70%) To clean your equipment, follow these instructions: 1. Shut down the Pulse Oximeter and take the batteries out of the battery cover. 2. Clean the display screen with soft, clean cloth dampened with a glass cleaner. 3. Clean the exterior surface of the equipment with soft cloth dampened with proper cleaner. 4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary. 5.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 9.2 Calibration and Verification The performance should be checked every year and after any kind of maintenance and repairing. Required Test Equipment: SpO2 signal simulator. Notice: The simulator cannot be used to assess the accuracy of a Pulse Oximeter probe or a Pulse Oximeter. 9.2.1 Control Key Verification Press Menu key to display the history data. 9.2.2 Sound Verification a. Set the Pulse Oximeter sound ON. b.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 9.2.4 SpO2 & Pulse Rate Alarm Verification a) Connect SpO2 Probe to the SpO2 connector on the Oximeter. b) Insert the operators finger into the finger sensor, the SpO2 measured value of a healthy person should be more than 96%. c) Set the SpO2 high limit as 90 and low limit as 80. d) Verify the SpO2 visual and auditory alarms, the background color of the SpO2 data should be red and “dudu” voice should be heard. 9.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 9.4 Warranty 9.4.1 Exempt and Limitations (one year warranty): a) Dynarex isn’t responsible for such damage caused by a force of nature. For example: fire, thunder flash, flood, cyclone, hail, earthquake, house collapse, commotion, plane falling and traffic accident, deliberate damage, lack of fuel or water, labor and capital bother, strike and stop-working etc.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 9.4.2 User Guarantees a) Please read user manual carefully before operation. b) Please operate and make daily maintenance as requested by the manual and warranty. c) Power supply and environment must be maintained under manual specifications. 9.4.3 What’s not Covered by Warranty • The device does not remain in original condition. • The shell of the device is broken or cracked. • Evidence of water damage.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL • Damage of probe caused by mechanical force doesn’t apply for free replacement. • During measurement of SpO2, principle leads to measuring value difficultly or inaccurate measurement. • Maintenance seal of Pulse Oximeter is not opened. 9.4.4 User’s Special Request for Warranty As indicated, according to the relevant electronic regulation of country, the warranty period is one year, limited warranty. The sensor’s warranty period is three months.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL SpO2 Display range: 0%~100% Measurement range: 70%~100% Resolution: 1% Accuracy: ±3% (70-100%) Unspecified (0-69%) Measurement Wavelengths and Output Power Red 660nm @ 3mw nominal Infrared 940nm @ 3mw nominal Pulse Rate Display range: 0~254bpm Measurement range: 30~235bpm Resolution: 1bpm Accuracy: 30~99bpm: ±2bpm; 100~235bpm: ±2% Operation Environment Operating temperature: 5°C~40°C Relative humidity: ≤ RH80%, no condensation Atmosphere pressure: 86kPa ~1
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Abbreviations CISPR EEC EMC ID IEC LED PR RF International Special Committee on Radio Interference European Economic Community Electromagnetic Compatibility Identification International Electrotechnical Commission Light Emitting Diode Pulse Rate Radio Frequency SpO2 Arterial Oxygen Saturation from Pulse Oximeter Units A °C kHz GHz Hz kg m min mW nm ampere centigrade kilohertz Gigahertz hertz kilogram meter, minute minute milliwatt nanometer bpm g MHz
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Symbols – % + < ≤ ± minus; negative percent plus less than less than or equal to plus or minus © / = > ≥ × copyright per; divide; or equal to greater than greater than or equal to multiply APPENDIX B Guidance and manufacturer’s declaration electromagnetic immunity The Hand Held Pulse Oximeter is intended for use in an electromagnetic environment specified below.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Guidance and manufacture’s declaration - Electromagnetic Immunity for Equipment and Systems that are not Life-Supporting 61000-4-6 3V/m Radiated 80Hz RF IEC to 2.5 GHz 61000-4-3 Where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacture and d is the recommended separation distance in meters (m).
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL Recommended separation distances between portable and mobile RF communications equipment and the Hand Held Pulse Oximeter The Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL NOTE2: These guidelines may not apply in all situations. Electromagnetic interference is affected by absorption and reflection from structures, objects and people.
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 46
Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL 47
Manufactured for: Dynarex Corporation Orangeburg, NY 10962 www.dynarex.
