Pulse Oximeter 7089
Contents
1. more than 9696 C Set the SpO high limit as 90 and low limit as 80 d Verify the SpO visual and auditory alarms the back ground color of the SpO data should be red and du du voice should be heard 9 3 Trouble Shooting e Can t power on the Oximeter Please check the batteries voltage oFF alarm Please check if the probe was connected with the Pulse Oximeter correctly or the finger is inserted fully If the sensor is with extension cable please check if the extension cable is connected with the sensor correctly E2 E8 E14 alarm Please contact our service department E3 E6 E7 alarm Check the patient s condition For other please contact our service department 36 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 b No service offer e The cost and insurance charge of disassembling refurbishing repackaging and conveying of the Pulse Oximeter or the part of it e Damage or loss sustained due to inspected or repaired by other institutions that is not covered e The damage and failure caused by user or its representa2. Environmental Requirements 18 3 3 Connect the Senis OE 19 Starting or Shutting Off the Oximeter 20 4 Setting ID Date and Time essere 20 4 1 Date 6 Hime 21 4 2 ID Number sisse abdo EQ RESO DAR 22 5 Take Measurement 22 5 1 Factors That May Affect The Measurement 23 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 6 History Data Reviewing eere rere rece ee ener er tnanse 26 6 1 Character Definition esee 26 6 2 Reviewing 26 7 Alarm Setting 27 7 1 27 7 2 Character Definition esses 28 7 3 SOO Alarm Setting season MUNERE 28 7 4 PR Alarm Setting essere 29 7 5 pto en yaris 29 7 6 Alarm Activation cccsecscscssssssscsssssscsssecsssesscsssesscseees 30 8 Beep in fe RD 31 9 Maintain and Cleaning eese ee tentntes 32 9 1 Safety 32 9 2 Calibration and Verification 35 9 3 Trouble Shooting 36 9 4 Warranty 37 APPENDIX A Specifications 39 APPENDIX eee Re ee P 42 OXIMETER SERIES PULSE OXIMETE
3. alarm or physiolog ical alarm occurs the lamp indicated will turn red 5 Power button 6 Navigation buttons you can select and set the different parameters These three buttons below are also used as shortcut buttons a Press the up button the unit will display the ID number b Press the right or left button the unit will display the Error Code 7 Menu button You can return to the measurement screen or switch the main menu item by this button 8 Reserved function 9 off on Indicator When is off the lamp indicated by it is on 10 Alarm light When there is an alarm the associated lamp will be lighted 11 Pulse bar The pulse bar is in proportion to the pulse volume Note This manual describes all features and options However equipment may not have all accessories 14 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 Battery cover 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 i 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 p
4. 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 Prolonged use may cause blisters skin deterioration and discomfort e When connecting this Oximeter to any instrument verify proper operation before clinical use Refer to the instrument s user manual for full instructions The equipment connected to the Pulse Oximeter s data interface must be certified according to the respective IEC standards i e IEC950 for data processing equipment or IEC 601 1 for medical electrical equipment All combinations of equipment must be in compliance with IEC601 1 1 systems requirements e Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death so pay close attention to the sensor and inspect it often The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation e Do not rely exclusively the audible alarm system for patient monitoring Adjustment of alarm volume to off may result in a hazard to the patient Remember that alarm settings should be customized according 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 m
5. HAND HELD PULSE OXIMETER INSTRUCTION MANUAL e Reorder No 7089 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 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 We do not assume any liability arising out of any infringements or patents or other rights of third parties Copyright O 2013 All rights reserved Contents of this material are subject to change without prior notice OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL Contents assem dn XE OUR tU pU FO DR DR UE 6 1 1 Brief 6 1 2 Safety Information ehe beth vexat 6 1 3 Equipment Symbols 11 1 4 Equipment Classification sss 12 1 5 Package Contents 12 2 General Descriptions 13 2 1 Front Panel 13 2 2 Rear Panel 15 2 3 Product Features 17 2 4 Intended Use usce 17 3 Getting Started oen aded 18 3 1 Unpacking and Checking 18 3 2
6. R INSTRUCTION MANUAL 1 Introduction 1 1 Brief Introduction Thank you for purchasing the Hand Held Pulse Oximeter The device is designed to measure SpO and PR delivering visual and audio alarm sensor off alarm data storage and review etc Please read this manual carefully before using it 1 2 Safety Information Conception of Warning Precaution and Notice The Warning Precaution and Notice in this document means Warning Indicates a potential hazard or unsafe practice that if not avoided will result in death or serious injury Caution Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage Notice Provides application tips or other useful information to ensure that you get the most from your product WARNINGS Before putting the system into operation verify that the equipment connecting cables and accessories are in correct working order and operating condition To avoid explosion hazard do not use the Oximeter in the presence of flammable anesthetics vapors or liquids Do not open the equipment housings electric shock 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 e The Pulse Oximeter is specified for use by medical professionals only e Prolonged use of the probe sensor or
7. against electrical shock Internal electrical power source equipment According to the degree of protection against Type B equipment electrical shock Ordinary equipment enclosed equipment without protection against ingress of water According to the degree of protection against harmful ingress of water According to the methods Non sterilizable of sterilization or Use of liquid surface disinfection disinfectants only According to the continuous operation mode of operation Equipment not suitable for use in the presence of a flammable anesthetic mixture air or with oxygen or nitrous oxide 1 5 Package Contents 1 Pulse Oximeter manual 4 USB cable 2 Sensor manual 5 Software Disk 3 Finger Sensor w cable 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 SpO and pulse rate value time amp 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 SpOz SpO value 2 PR Pulse rate 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 m Alarm Indicator When technical
8. arm Indicators If the alarm is activated through over limitation of physiological alarm corresponding data area is flashing If the alarm is activated by more than one physiological alarm each parameter will be displayed when flashing 27 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 SpO alarm du du du du du beeps every 8 seconds e Medium priority PR alarm du du du beeps every 8 seconds Low priority Sensor off or finger out beeps every 20 seconds 7 2 Character Definition SHI High alarm of SpOz La Low alarm of SpOz2 High alarm of pulse rate PLn Low alarm of pulse rate H Turn on or turn off the Alarm 7 3 SpO Alarm Setting SHI SpO high alarm Turn on the Pulse Oximeter and hit the menu button three times and you will see the screen showing high alarm of SpO refer to Fig 9 Press the up or down button to increase or decrease the number Press the right button to select other alarms for setting or press menu button save the alarm setting s and enter into another parameter item The high alarm SpO2 setting range is 71 100 96 28 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 5 SpO2 Low alarm After finishing the high alarm setting press the rig
9. ay 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 Do come into contact with the patient during defibrillation Otherwise serious injury or death could result Single use accessories should never be reused To avoid inadvertent disconnection route all cables in a way to prevent a stumbling hazard Wrap and secure excess cabling to avoid risk of entanglement or strangulation by patients or personnel CAUTIONS e Autoclaving ethylene oxide sterilizing or immersing the sensors in liquid may cause inaccurate readings To ensure patient safety use only parts specified in this manual e The operator must be thoroughly familiar with the information in this manual before using the device e Magnetic and electrical fields are capable of interfering with the proper performance of the equipment For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant 8 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 e Unplug the sensor from the Oximeter before cleaning or disinfecting it If liquid is accidentally sp
10. condensation may occur as a result of temperature or humidity difference In this case never start the system before the condensation disappears 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 Plug the SpO extension cable in the multifunctioning connector on top of the Oximeter as shown in Fig 3 Ensure that the sensor is firmly plugged in Fig 3 Note The connector is also applied to upload data to Med View software for reviewing Detailed information is referred to MedView software operator s manual 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 Disconnect the S
11. ded disinfectants include ethanol 70 isopropanol 70 glutaraldehyde type 2 liquid disinfectants CAUTION Never use autoclaving EtO or formaldehyde for disinfection 34 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 SpO 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 You hear the simulated heart beep sound 9 2 3 SpO2 amp Pulse Rate Measurement Value Verification a Connect SpO Probe to the SpO connector on the Oximeter b Insert the operator s finger into the finger sensor the SpO measured value of a healthy person should be from 9596 to 9996 and the pulse rate is the same as a heart rate C If SpO Simulator is available verify the accuracy of Oxygen Saturation Value with probes as follows Oxygen Saturation Tolerance 96 2 86 2 7096 43 35 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 9 2 4 SpO amp Pulse Rate Alarm Verification a Connect SpO Probe to the SpO connector the Oximeter b Insert the operators finger into the finger sensor the SpO measured value of a healthy person should be
12. e P is the maximum out put power rating of the transmitter in watts W according to the transmitter manufacturer NOTE1 At 80MHz and 800MHz the separation distance for the higher frequency range applies E 44 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 45 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 46 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 47 Manufactured for Dynarex Corporation Orangeburg NY 10962 www dynarex com Made in China
13. e user s 5 2 The user s pulse rate Hid The user s ID number HNI The minute of the history data HH The hour of the history data Hd The date of the history data Ha The month of the history data HY The year of the history data 6 2 Reviewing Operation On normal screen after hitting the menu button one time you can enter the data reviewing screen shown as the Fig 8 By the up or down button you can review the new measure of a single group of data including SpOz pulse rate ID number data and time Fig 8 26 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 High priority the highest level alarm indicates the patient is in a very dangerous situation Medium priority indicates the warning should be paid attention to Low priority indicates the technical alarm caused by the device itself Alarm of this Oximeter includes technical and physiological alarm All three priorities are divided by a built in module and can not be changed by a user Visual Al
14. finger and the Oximeter sensor probe is kept as still as possible Description of Fig 7 SpO SpO value displayed value is 98 PR Pulse rate displayed value is 67 bpm 5 1 Factors That May Affect The Measurement During operation the accuracy of oximetry readings can be affected by the following factors 23 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 3 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 e Shock or cardiac arrest e Temperature of the unit After the administration of a cardiovascular drug Anemia e Evidence of ventilation perfusion mismatch 5 1 2 Instrument performance depends on the wavelength absorption for oxyhemoglobin and deoxyhemoglobin If there are substances absorbing the same wavelength this would induce false or low SpO values The following may affect these values e carboxyhemoglobin methemoglobin e methylene blue Indigo carmine 5 1 3 Extremely high illumination could affect the SpO measurement Use a semi translucent or opaque cover to shield the sensor 24 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 5 1 4 Other factors a High frequency electrosurgical interference from exter nal devices including defibrillators b Placement of a sensor on an extremity that currently has installed a blood pres
15. formance requirements e Make sure that the Pulse Oximeter is in good working condition In case of any damage or abnormality do not use the Pulse Oximeter Contact your hospital s biomedical engineers or your service personnel immediately Cleaning Your equipment should be cleaned on a regular basis If there is heavy pollution or lots of dust and sand in your location the equipment should be cleaned more frequently Before cleaning the equipment consult your hospital s regulations for cleaning the equipment Recommended cleaning agents are Mild soap diluted e Ammonia diluted e Sodium hypochlorite bleach diluted 33 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL e Hydrogen peroxide 3 e 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 damp ened 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 Dry your equipment in a ventilated cool place Disinfecting Disinfection may cause damage to the equipment and is therefore not recommended for this Pulse Oximeter unless otherwise indicated in your hospital s servicing schedule Clean the Pulse Oximeter before disinfecting it The recommen
16. hones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretical ly with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Hand Held Pulse Oximeter is used exceeds the applicable RF compliance level above the Hand Held Pulse Oximeter should be observed 43 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 The customer or the user of the Hand Held Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the Pulse Oximeter as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter m 150KHz to 80 MHz 80MHz to 800 800MHz to 2 5 GHz power of _ 3 5 transmitter V W 1 For transmitters rated at a maximum output power not list ed above the recommended separation distance in meters m can be estimated using the equation applicable to the frequency of the transmitter wher
17. ht button and you will see on the screen the low alarm of SpO setting refer to Fig 10 Press the up or down button to adjust the number The low alarm SpO setting range is 70 99 Fig 10 7 4 PR Alarm Setting After SpO low alarm setting press the right button and you will see the screen shown as Fig 11 for setting PR high alarm The high alarm PR setting range is 31 254 bpm Press the up or down button to adjust the number Then press the right button for setting the low PR alarm refer to Fig 12 The low alarm PR setting range is 30 253 bpm Spo2 PHI FR OPM 393 7 5 Alarm on off After PR alarm setting press the right button you will see the alarm on off setting screen Press the up or down button to set the alarm on or off 29 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 7 6 Alarm Activation Alarm will be activated with the following conditions Physiological alarm The alarm will work when the SpO value or pulse rate gets beyond the high limit or goes below the low limit The difference is their priority the SpO has the high priority while the pulse rate has the medium e Technical alarm error code a Error Definitions 2 E3 E4 ES E 6 EC E 8 Program memory is damaged Data memory is damaged Signal strength is too weak to be detected Sensor is unplugged No finger is inserted or sensor goes wrong The Oximeter can
18. illed on the unit clean and dry thoroughly before reuse not to use the SpO and NIBP measurement the same arm at the same time This could potentially affect measurement accuracy e At the end of its service life the equipment must be disposed of in compliance with the guidelines regulating the disposal of such products If you have any questions concerning disposal of the equipment please contact your distributor Always install or carry the equipment properly to avoid damage caused by drop impact strong vibration or other mechanical force NOTES e Put the equipment in a location where you can easily see the screen and access the operating controls e Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed e The software was developed in compliance with IEC60601 1 4 The possibility of hazards arising from software errors is minimized e SpO measurements may be influenced by high ambient light especially sunlight Shield the sensor area if necessary OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL e Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine and fluorescein may influence the accuracy of the SpO reading e Any 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 SpO reading
19. infection For methods to control infection consult your hospital s Infection Control Officer or Epidemiologist Keep your equipment free of dust and dirt To avoid damage to the equipment follow these rules Always dilute according to the manufacturer s instructions or use lowest possible concentration Do not immerse part of the equipment into liquid Do not pour liquid onto the equipment or any accessories e Do not allow liquid to enter the case e Never use abrasive materials such as steel wool or silver polish or erosive cleaners such as acetone or acetone based cleaners CAUTION If you spill liquid on the equipment or accessories contact the manufacturer Note To clean or disinfect reusable accessories refer to the instructions provided 9 1 Safety Checks Before every use or after your Pulse Oximeter has been used for 6 to 12 months or whenever your Pulse Oximeter 32 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 e Make sure that the environment and power supply meet the requirements e Inspect the equipment and its accessories for mechanical damage e Make sure that only specified accessories are applied e Inspect if the alarm system functions correctly e Make sure that the batteries meet the per
20. meter setting pictures 21 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 normal screen press the up button the digital LED shows the current ID number It will automatically turn back to normal screen Fig 4 5 Take A Measurement SpO2 measuring is a non invasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light The light emitted by the red infrared light emitting diodes passes through the tissue and is converted into electrical signals by a photodiode 22 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 Note To maintain the highest degree of accuracy it is recommended that the
21. nd 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 x RH8096 no condensation Atmosphere pressure 86kPa 106 Power supply Two AA alkaline batteries not included Working time work for 30 hours continuously Store and replay Store and replay 72 hour SpO296 and Pulse rate value the time interval is 4 seconds 40 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL Abbreviations CISPR International Special Committee on Radio Interference EEC European Economic Community EMC Electromagnetic Compatibility ID Identification IEC International Electrotechnical Commission LED Light Emitting Diode PR Pulse Rate RF Radio Frequency SpO2 Arterial Oxygen Saturation from Pulse Oximeter Units C o mW 41 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL Symbols minus negative O copyright percent per divide or plus equalto less than gt greater than lt lessthanorequalto gt greater than or equal to plus or minus x 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 The customer or the use
22. not detect for pulse It takes too long to search for pulse Pulse alarm is malfunctioning 30 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL E9 The SpO2 value is lower than the low limit E 10 The SpO value is higher than the high limit E11 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 e Check the error code Press the right key under normal screen it will indicate an error code To return to normal screen please press menu button again AN WARNING When alarm occurs DO as follows e Check which type of alarm is on e Check patient s condition if parameter alarm is on e Make the alarm mute if necessary e Check whether the alarm is in proper condition in case of no warning 8 Beep on off Press the menu key five times under the normal screen to enter access to this function the associated screen will be displayed Press up or down key to set the pulse beep on off 31 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
23. olarity as indicated by polarity markings and inside the battery cover 3 Close battery cover Close the battery cover and rotate the screw to the LU position and the batteries are locked Make sure that the polarity of the batteries is correct otherwise the unit cannot operate normally Battery Life And Replacement When the low power indication lamp is lighted please replace the batteries with new ones as needed Always turn the unit off before replacing the batteries Dispose of the used batteries according to the applicable local regulations AN Warnings If battery contents should get into your eyes immediately rinse with plenty of clean water Consult a doctor immediately Cautions Do not use batteries not specified for this unit OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL Do not insert the batteries with the polarities in the wrong direction Do not dispose of batteries in fire If battery contents should get on your skin or clothing immediately rinse with plenty of clean water 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 Do not use batteries of different types together Do not use new and used batteries together 2 3 Product Features Rubber grip design offers special protection Compact light weight design for simple one hand operation High brightness LED displays S
24. pO pulse rate and pulse bar Up to 99 patients ID and 72 hour record storage Visual amp audio alarm low battery alarm Data transfer to PC for storage or printing Convenient 2 AA size alkaline batteries not included 2 4 Intended Use The Hand Held Pulse Oximeter is intended for continuous monitoring spot checking of functional pulse oxygen saturation 96S5pO2 and pulse rate PR of single adults pediatric patients in hospitals and home care 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 WARNINGS Keep the packing material out of children s reach Disposal of the packaging material should observe the applicable waste control regulations Before use please verify whether the packages especially the package is intact In case of any damage do not apply the Pulse Oximeter to the patient 3 2 Environmental Requirements The operating environment of the equipment must meet the requirements specified in this manual When the equipment is moved from one place to another
25. pO extension cable from the Pulse Oximeter 3 Press and hold the Power button for 4 seconds WARNING Do not use the Pulse Oximeter if you suspect it is not working properly or if it is mechanically damaged Contact your distrib utor immediately 4 Setting ID Date and Time Always set the date and time before using the unit for the first time Set different ID numbers for different users Check and make sure the date and time are correct 20 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 amp Time Setting Press the menu button four times under the screen to enter time setup Character Definitions ri Is the minute The setting range is 0 59 H 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 The setting range is 0 20 Press the left or the right button to select different date amp time parameters Press the up or down button to set your suitable time amp date Year setting for example 1 Press the power button for 3 seconds to turn on the unit 2 Hit the menu button four times to enter into the time setting screen shown as Fig 4 Press the up or down button to set the suitable year and then press the left or right button to enter into the other date and time para
26. r of the Pulse Oximeter should assure that it is used in such an environment Immunity Compliance Electromagnetic Test Level environment guidance Electro 6kV 6kV Floors should be static contact contact wood concrete Discharge 8kV air 8kV air or ceramic tile If ESD floor are convert IEC61004 2 ed with Synthetic material the relative humidity should be at least 30 42 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 3 5 P d y 80MHz to 800MHz 1 Radiated 80Hz d ERE 800MHz to 2 5GHz Ei Where P is the P maximum output 61000 4 3 power rating of the RF IEC to 2 5 GHz transmitter in Watts W according to the transmitter manufacture and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80MHz and 800MHZz the higher frequency range applies NOTE2 These guideline may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base situation for radio cellular cordless telep
27. s e Remove fingernail polish or artificial fingernails before applying SpO sensors Fingernail polish or artificial fingernails may cause inaccurate SpO readings e Optical cross talk can occur when two or more sensors located in adjoining areas It can be eliminated by covering each site with opaque material Optical cross talk may adversely affect the accuracy of the SpO readings e Obstructions or dirt on the sensor s red light or detector may cause a sensor failure Make sure there are no obstructions and the sensor is clean For routine equipment maintenance please refer to the service procedures at the associated section as indicated in the manual As to the other concerns for attention please carefully look through the specific chapter in enclosed instructions e This manual describes all features and options This model may not have all accessories mentioned in this manual Federal Law restricts this device to sale by or on the order of a physician 10 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 1 3 Equipment Symbols Attention Refer to the relevant information Read operator s manual carefully before using the Oximeter Type BF applied part Production date Manufacturer s address Low power indicator Serial Number OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL 1 4 Equipment Classification Classification according to IEC 60601 According to the type of protection
28. sure 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 e Use only SpO sensors provided by manufacturer Other SpO sensors may cause improper performance Do not use an SpO sensor with exposed optical components Excessive patient movement may cause inaccurate measurements e Tissue damage can be caused by incorrect operation or misusing sensor Inspect the sensor site to ensure the skin s integrity and the adhesion position of the sensor is correct More frequent inspection should be taken if necessary e Loss of pulse signal can occur in any of the following a The sensor is too tight b There is excessive illumination from light sources such as a surgical lamp a bilirubin lamp or sunlight C A blood pressure cuff is inflated on the same extremity as the one to which an SpO sensor is attached 25 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL NOTES Pulse sensor should obviate the light source e g radial lamp or infrared lamp gt Set the upper limit of SpO2 alarm to 10096 means cut off the upper alarm High density of oxygen will cause adverse affection to the neonate So the upper limit of SpO alarm must be selected prudently according to the 6 History Data Reviewing 6 History Data Reviewing 6 1 Character Definition Th
29. the instrument or its fittings All Probe and its accessories are not eligible for free replacement If any code label of parts are damaged or missing this warranty shall become null and void 38 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL Damage of probe caused by mechanical force doesn t apply for free replacement e During measurement of SpO principle leads to measuring value difficultly or inaccurate measurement e 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 Storage and Transportation Storage Storage Temperature 20 C 55 C 4 F 131 F Relative Humidity lt 9096 no condensation Transportation Transport by airline train or vessel after packing according to request APPENDIX A Specifications Display Data SpO296 PR Others connection status of probe and other alarm information Alarm Alarm SpO296 and pulse rate value probe off battery exhausted Alarm mode audio alarm visual alarm and error code Alarm limits range 7096 10096 Default limits High 9996 low 9096 39 OXIMETER SERIES PULSE OXIMETER INSTRUCTION MANUAL SpO Display range 0 100 Measurement range 70 100 Resolution 1 Accuracy 3 70 100 Unspecified 0 69 Measurement Wavelengths a
30. tive who isn t authorized to use the device according to the operator s manual C The damage or loss sustained due to connection to peripheral equipment such as printer computer etc that are not provided by our company are not covered by the warranty d Responsibility limitation In the duration of the one year warranty if user changes the parts manufactured by other manufacturers without our company permis sion the warranty is null and void 37 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 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 e Evidence of water damage e Accessories or appearance of unit is physically abused e Evidence of crushing damage to the probe e Original package is not used during transportation e Non authorized service is performed on Oximeter e Damage to a product as a result of not conforming to manual specifications The work environment is not eligible Any smear or marks that do not belong to the instrument and cannot be removed from the outside surface of the instrument Thecircuit is shorted and damaged due to liquid or other substances in
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