Acc U Rate® CMS 500D
Contents
1. 18 carbon monoxide blood gas analyzer 6 2 2 Determination of Oxygen Saturation Accuracy The claimed oxygen saturation is supported by coverage of the entire range of clinical research measurements 6 2 2 1 Data Collection In the clinical test process data points are recorded with comparable density in the claimed entire range 6 2 2 2 Data Analysis For each claimed range the oxygen saturation accuracy of the pulse Oximeter should be represented in the form of mean root square of the difference between the measured values of oxygen saturation and the reference value The formula is as follows Arms Arms accuracy n test sample quantity SPO measured value of pulse oxygen saturation during the first measurement using the finger pulse Oximeter Sri reference value of pulse oxygen saturation during the i measurement using the carbon monoxide blood gas analyzer 6 2 2 3 Characteristics of Population under Clinical Research The summary clinical research report for evaluating SPO2 accuracy should state whether the tested object suffers from disease or is healthy and should state the skin color age and gender of the tested object 6 2 3 Data updating interval Data averaging and other signal processing will have an influence on the display and transmission of SpO2 and the pulse rate The range of prompt signal generation delay is I to 20 seconds depending on alert parameter settings and the difference between disp2. Distributed by CMS Mobility Inc dba Summit DME 12919 Southwest Freeway Suite 100 Stafford TX 77477 Phone 1 832 939 8290 http www cmsmobilityusa com cs cmsmobilityusa com Acc U Rate CMS 500D ATE Finger Pulse Oximeter Ey User Manual CMS Mobility Inc dba Summit DME 12919 Southwest Freeway Suite 100 Stafford TX 77479 http www cmsmobilityusa com Copyright CMS Mobility INC All rights reserved CMS Mobility Inc owns and reserves all of the rights comprised in the copyright of this document No part of this document may be changed excerpted copied reproduced or imitated in any form or by any means without prior written consent of CMS Mobility Inc All statements information and recommendations in this document are provided AS IS without warranties guarantees or representations of any kind either express or implied The information in this document is subject to change without notice CMS Mobility Inc reserves the right of final interpretation of this document Qo i is a registered trade mark of CMS Mobility Inc Version 1 2 Prepared in May 2015 6 4 Storage and Transportation 50 Temperature 93 RH O S o ai o c 10C 50 FA 10 93 Nar non condensing 10 106kPa bk Stack height D Atmospheric pressure Hemor ioe 50kPa 106kPa m 50kPa layers SBa Keep away from Place upward j rain 19 Contents Letter COU GOES sssssssssisesssssosesosssosososesss
3. to 100 Aleasance saturation Lower limit 50 to 100 8 Paihe r te Upper limit 25 bpm to 250 bpm Lower limit 25 bpm to 250 bpm 1 of the preset value Alert error SULLO The greater of 10 of the preset Pulse rate value and 5 bpm 8 Capability to resist ambient light interference Compare the measured value of oxygen saturation in the case of indoor natural light and existing illumination sources with the measured value of oxygen saturation in the darkroom condition The deviation is smaller than 1 6 2 Technical Description 6 2 1 Oxygen Saturation Accuracy The accuracy is 2 in the absence of movement between 70 to 100 Note The oxygen saturation accuracy is a root mean square of the difference The measured values of the instrument are distributed according to statistical probability Only about two thirds of the measured values of the Pulse Oximeter fall within Arms of the measured values of a 16 PR based on your blood flow If the blood flow in your finger drops below a certain level the pulse oximeter will not be able to function 6 Some people with medical conditions such as anemia hypotension and hypothermia can experience an inaccurate reading during use If that may be the case for you we suggest that you consult a physician Chapter 6 Technical Description and Safety Type 6 1 Technical Specifications 1 Dimensions 58 0 mm Width x 32 0 mm Depth x 33 2 mm Height Weight 49 4g including the h
4. detect a signal 3 3 2 Switching the Display Press lt 0 5 sec the functional key during measurement mode to change the display mode The six different modes are shown in the figure below Choose the mode that is the most convenient for you SpO2 MllbpmPR Ydwdq fm zods 98 75 sz 86 AAAAAAAA IVV VVV SpO2 bpmPR fll Mi y quidgq zods Te N 01 OO SpO2 MbpmPR XYdwudq mi zods 9875 7486 A Replace the batteries when the batteries are low and the symbol C flickers on the screen 3 3 3 Plethysmograph SpOz M bpmPR 98 75 hat ba ba ns 4 Plethysmograph The plethysmograph indicates the amount of blood flow detected by the pulse oximeter Each wave corresponds to a heartbeat and the wave amplitude corresponds to the amount of blood detected by the pulse oximeter flowing through the blood vessels If the wave amplitude is low this means that your blood perfusion is too low for a reliable read You should retake your measurement and make sure that your finger is positioned right under the LED lights 3 4 Parameter Settings 3 4 1 Power On Key Functional Key Operations PRESS lt 0 5 sec the Power On functional key to turn on the pulse oximeter 10
5. Clen sosse aee o a e rE E edema 12 4 2 DisinfectiOti sisicsuincuianstessiaastanetsnviaisisvsiacstoustenniexsianniangiacasmiaasiasiansees 13 Chapter 5 Maintenance and Troubleshooting ssscccccccssssssscssssssccccssssssccscssssceesssssecces 13 5 1 Maintenant E esssssissessssssssssssssssssssesosisssssososo su sossssss sasoina siosaia soss 13 5 2 Troublesh otinp vesssisvcccossnucenniadssaiacacenmemtssissanadaconnaleuniasstannsarsnecnnes 13 5 3 Tips to getting a good TEAMING cccciscccscainissaiscasscccesasesacatacssasetesserceecesa 14 Chapter 6 Technical Description and Safety Type ssssssssssssssssoooossessesssoooooseessesssssoocessssee 15 6 1 Technical SPECIICAIONS isnusenvissssansdasveonndaustecsenastanntsxsionsisxitacasannisnanss 15 6 2 Technical DES CHIDO sss siiaucntwasanseassiaesanuaasawesenessuineigauuensiancccesianuadesa 16 6 3 Safety TV Dec sananeianescseienasn acasuaascaneneuaviucssulsensisutcssaudeeiunesssiseucdinenansass 18 6 4 Storage and Transportation scisssssssveccavsnnseneisssroieconmnaanianssiorsccavonvaennes 19 Letter to Users Thank you for choosing our Acc U Rate CMS 500D Deluxe Finger Pulse Oximeter By listening to our customers and applying some simple technological innovations you will come to see that the CMS 500D is one of the most user friendly reliable and comfortable pulse oximeters that you will ever come to own Before using this product please carefully read the manual and follow the instructions stated he
6. bin reduced hemoglobin present in the blood It is an important physiological parameter involved in respiration and circulation The Pulse Oximeter feature herein is small portable non invasive and easy to use The user only needs to insert a finger into the chamber to measure his her SpO2 and pulse rate 2 2 Working Principles and Usage Oxygenated blood absorbs light at 660nm red light Light beams whereas deoxygenated blood absorbs light preferentially at eet 905nm infra red A pulse oximeter works by passing a i beam of red and infrared light through a pulsating nen el capillary bed and then measure the amount of red and infrared light emerging from the tissues via a sensor To improve accuracy the CMS 500D uses a proprietary algorithm to collect data from pulsatile arterial blood and ignores local noise from the tissues The relative absorption of light by oxyhemoglobin HbO and deoxyhemoglobin is then processed according to the Beer Lambert s law and a qualitative measurement of the users oxyhemoglobin status i e Oxygen saturation level SpO2 derived Due to the sensitivity of the pulse oximeter you should keep your finger stationary during measurement It is recommended that you use this instrument for measurement before or after sports Do not use for continuous monitoring 2 3 Applicable Scope This device is intended for non medical use in healthy people to monitor their pulse and blood oxygen levels for sports and o
7. eight of the two AAA dry batteries 2 Peak wavelength range of the light emitted from the probe red light 660 nm 3 infrared light 905 nm 5 3 Maximum optical output power of the probe 1 2 mW for infrared light 905 nm Note While curing disease such as blood vessel proliferative lesion using photodynamic therapy avoid using the Oximeter for measurement because the light within the wavelength range emitted by the probe of the Oximeter may influence non lesion tissues of the human body 4 Working power supply and current Internal Power Supply Two 1 5 V dry batteries Working Current 5 Normal working condition Working Temperature 5 C to 40 C 41 F to 104 F Relative Humidity 15 to 80 non condensing Atmospheric Pressure 70 kPa to 106 kPa Rated Voltage DC3 0V 6 Default values and conditions of alert Parameter Value Upper limit 100 Lower limit 94 Upper limit 130 Lower limit 50 When the alert switch is on and the actual measured value goes beyond the preset alert 15 Oxygen saturation Pulse rate Alert condition Some important information that you must learn Information that is necessary for you to protect this product Attention against damage Chapter 2 About The Product 2 1 Overview SpO gt stands for peripheral capillary oxygen saturation Oxygen saturation is defined as the ratio of oxyhemoglobin HbO2 to the total concentration of hemoglobin i e Oxyhemoglo
8. ently at Please see figure below 3 4 2 Alarm Setting V2 0T OT Alm Setup Sounds setup Alm SpO2 Alm Lo Demo PR Alm Hi Restore Brightness Exit Interface 1 Interface 2 To turn the alarm on off PRESS the power on key functional key to move x to Alm HOLD the power on key functional key to switch the option from on to off or vice versa When Alm is set to on and the measured values of the blood oxygen saturation SpO2 and or pulse rate PR go beyond the stated upper or lower limit See 3 3 6 to set parameters for Alarm the alarm will go off When Alm is set to off the alarm is deactivated The alarm will not go off regardless of your SpO2 and or PR values 3 4 3 Beep Settings To turn the beeping sound on off while measuring your pulse rate PRESS the power on key functional key to move to Beep HOLD the power on key functional key to switch the option from on to off or vice versa When Beep is set to on a tick will be heard along with pulse beats during pulse rate measurement When Beep is set to off no sound will be heard during pulse rate measurement 3 4 4 Demo Mode mxn To turn demo mode on PRESS the power on key functional key to move to DEMO HOLD the power on key functional key to switch the option from on to off or vice versa 3 4 5 Restoring Factory Settings PRESS the functional key to move to the Restore option HOLD the power on key functional key to restore pulse oximeter to factory settin
9. gs OK will be displayed Move to the Next option and hold the functional key to reset oximeter to factory mode 11 A Ensure that the batteries are installed with correct polarities to avoid damaging the instrument 2 Tnstalling the lanyard Remove the silicon cover Thread the thin end of the lanyard through the lanyard hole thread the coarse end of the lanyard through the thin end of the lanyard and tighten the lanyard Put the silicon cover back on 3 Switch on the power supply of the pulse Oximeter Stick one finger completely into the silicon padded finger chamber of the Oximeter The fingernail should be facing upward Release the clip and press the power key to power on the Pulse Oximeter A If you do not insert your finger completely into the chamber the measurement will be inaccurate 8 Note Before each test clean the measured finger and the silicon part of the Oximeter that contacts the finger with medical alcohol The silicon is non toxic soft and hypoallergenic 4 Reading measured data of Oxygen Saturation and the Pulse Rate from the OLED screen Do not move your finger during measurement Keep your body as still as possible After the readings become stable read the measured values of the oxygen saturation and pulse rate on the LED screen 5 Switch off the power supply of the Oximeter The Oximeter will automatically shut down 16 seconds after you remove your finger or if it does not
10. layed values The maximum alert status delay is 4 seconds the maximum alert signal generation delay is 20 seconds the average alert status delay is 2 seconds and the average alert signal generation delay is 10 seconds 17 oxygen levels during sports and or aviation only People who need SpO2 and pulse rate measurements because of a medical condition should not use the CMS 500D and should consult with their physician The following factors may affect the accuracy of the measurement The Oximeter is used in an environment involving high frequency devices such as high frequency electric knives and CT apparatuses Ambient light intensity is too bright Hence please avoid direct exposure to strong light such as beams from operating lamps or sunlight during measurement The probe of the Oximeter is placed on the same arm that a blood pressure cuff arterial duct or intravenous injection is placed The user suffers from hypotension severe vascular atrophy severe anemia or low oxygen The user is in sudden cardiac arrest or shock state The user is wearing nail polish or artificial nails 1 2 Warnings Warning Do not use the Oximeter in an environment with any flammable gases flammable anesthetic or other flammable substances Warning Keep unit and lanyard away from children as the included lanyard may present an entanglement or choking hazard to small children Adult supervision required never leave children
11. n apparatus Troubleshooting 13 Chapter 3 Product Structure Parameter Settings and Operation Steps 3 1 Schematic Structural Diagram OLED screen Power on key functional key ABS plastic casing Battery cover Note The photo in this manual may differ from the actual model 3 2 Schematic Diagram of Display The following figure shows the information display on the OLED screen of the Oximeter in normal detection state Symbol of oxygen saturation 2 Measured value of oxygen saturation Bar graph 4 Plethysmogram Measured value of pulse rate Symbol of pulse rate Battery power indication 3 3 Operation Guide 3 3 1 Operation Steps 1 Installing the batteries Install the two AAA batteries into the battery slot according to polarity indication and mount the battery cover 3 4 4 Brightness Setting mxn To change brightness PRESS the power on key functional key to move to BRIGHTNESS HOLD the power on key functional key to set the brightness There are 5 brightness setting 5 is the brightest The factory default setting is 4 Please note that brighter setting will drain the battery faster 3 4 5 Alarm Range Setting To change the alarm range settings PRESS the power on key functional key to move to Alm Setup and HOLD the power on key functional key to enter in Menu Interface 2 should be at Sounds Setup Press the power on key functional key to move to the option you de
12. o soso soso sese sose sssesssseooneosesosososo sose sssessssssssooonesss ss soss soosis 1 Chapter 1 Precautions Warnings and CONVENTIONS ccccccsseesssssscccccsssssssssssccesesssssees 1 Ld PCCHUNONS scnuiinnnninsninie mnie 1 1 2 Warning S sass asada saauusdatacatidadadauadudaawasastnassedakacatatacadaradsauansudaleastoisteasties 2 1 3 Symbol Conventions sisiscccitiecsnsasssnivecdasnceasnisiasstinecsaangtnissacaiveeesseaaeanes 3 Chapter 2About The Prag uch vossissisvessenstsnnieasisnsiacdvonstansiaasianscacataneisnatssshaesionensxaiansissilaassanns 4 2 1 OVNI OW E E E 4 2 2 Working Principles and Usage sciisssssssivcesesssacasnassccscsscsecesxevancasonscesssnse 4 2 3 Applicable SCOP GC eswscnsconssssviscesssveananssanmnnccanenneasnisssiiageanmearnnatianieeesaans 4 2 4 Product FP COUT ES ssscsisniscracdacacarnadaswasdestantidedeanandaenpesisntacretaastastnantaesees 4 Chapter 3 Product Structure Parameter Settings and Operation Steps 6 3 1 Schematic Structural Diagram sisssiicessorsasnntiastanrieconversansiaastinctansbanncs ct 6 3 2 Schematic Diagram Of Display sasciiscccssrcanasacscasiaccicansensadacdessvesesaasvanseas 6 3 3 Operation Guide siniiscavinicccassacasnaasisnseastuanantsanaasuinencasnaaanenddeninaadviniacaiack 7 3 4 POVNET SCUMBS isssvsssisscaconnsacnienasssviacseannaeniasionarcenadsniassnanneeennns 10 Chapter 4 Cleaning and Disinfection ssascccsiscasssscaccasatcstesscsivacessasucacanecacensesdesncansieasesanaceense 12 4 1
13. or and the LED lights The user s blood perfusion is too low to be detected The finger is not placed properly between the sensor and the LED lights Place the finger at the correct position Make sure nothing is restricting your blood flow Place the finger at the correct position Ensure that the user s body is The user is moving stationary his finger or body The Oximeter The batteries are Replace the batteries cannot be powered empty or are not Correctly install the on installed at all batteries according to The batteries are the polarity incorrectly installed indication The Oximeter is Contact the damaged distributor This is normal Just turn on the pulse oximeter again Replace the batteries The screen is Ifthe Oximeter does suddenly off not detect any signal within 16 seconds it will automatically power off The batteries are empty 5 3 Tips to getting a good reading 1 Make sure that your finger is put deep into the probe such that the fingertip is directly in between the LED sensor and the LED light source 2 Make sure your finger is stationary in the probe while you are measuring your SpO2 levels 3 If your fingernails are too long this may obstruct the sensor from the LED lights Please make sure that your fingernails are kept short 4 Excessive ambient infra red light especially for people who use the pulse oximeter in an overly bright lit room can interfere with
14. r aviation only However you are not advised to use this instrument during sports activities as finger movement may lead to inaccuracies It is suitable for users between 15 to 60 years old Do not use it for continuous monitoring 2 4 Product Features Lightweight portable and easy to use Six different displays options Dual color OLED screen to show measured values plethysmogram and bar graphs Large font display 4 Preset alarm function Battery low voltage indication Automatically shut down if no signal is detected after 16 seconds Low power consumption Two 1 5 V AAA batteries will allow the pulse oximeter to operate for approximately 30 hours 2 5 Limitations The pulse oximeter works by measuring the amount of oxygenated haemoglobin in your blood over a period of time Spot check pulse oximeter takes a reading every second and takes an average of 4 6 readings before displaying the result Hence you will have to wait at least 4 6 seconds before a result will be displayed on the monitor If the pulse oximeter fails to detect blood flow for the first few seconds then the results will be delayed accordingly The pulse oximeter does not work for people with naturally small fingers or low peripheral blood flow This is because the pulse oximeter would not have enough blood to take a measurement Please note that prolong use of a pulse oximeter hypotension vasoconstriction hypothermia and certain medications can lead
15. rein Check whether all accessories are complete against the packing list and whether any component is damaged during shipping If there is any damage or if you have any concerns please contact us at cs cmsmobilityusa com or phone 1 832 939 8290 with the following information 1 Product model 2 Serial number of the product 3 Your contact information and address The manual is updated periodically and the latest manual can be downloaded at http www cmsmobilityusa com cms 500d html Standard Packing List 1 Pulse OMe Axitcicssiscsinnnianannonand PC 2 AAA BattetY sssssssssssssssssssossessesssseossssssssssssssss 2 POS 3 LONGI casita nnn 1 PC 4 Silicon CoOVvef sssssssssssesssessseesoeesoe esseeceessssss L PC 5 User Manuadl sssssssesssessseesssesssesoscsessssseceeeee 1 PC Chapter 1 Precautions Warnings and Conventions 1 1 Precautions Do not attempt to repair the Pulse Oximeter by yourself Only certified engineers should maintain and repair it Change the contact position between the Oximeter probe and the finger periodically if you are monitoring your SpO gt levels and pulse rate for more than 2 hours Stop immediately if you have broken skin or the blood circulation of your finger is affected during prolong use This product is not designed to be used by newborn babies The pulse oximeter uses infrared light invisible to your eyes to measure your SpO gt levels Hence please do not stare at the light emi
16. sire to change SpO2 Alm Hi and SpO2 Alm Lo refer to the upper and lower limit of the SpO2 levels that you wish the alarm to go off at respectively PR Alm Hi and PR Alm Lo refer to the upper and lower limit of the Pulse Rate levels that you wish the alarm to go off at respectively While the symbol stays on the option hold the functional key to set the option to or In mode select the corresponding upper or lower limit option and hold the functional key to increase the upper or lower limit in mode hold the functional key to decrease the upper or lower limit Move to the Exit option and hold the functional key to return to the monitoring interface Chapter 4 Cleaning and Disinfection 4 1 Cleaning To clean the instrument power off and remove the batteries first Then clean the outer surface of the instrument including the LED screen using a piece of dry soft cloth dipped with 75 medical alcohol Do not immerse the unit in alcohol Attention Do not use any strong dissolving agent such as acetone Attention Do not rub the body of the instrument using materials such as steel wire balls or polished metal objects Attention Ensure that there is no washing liquid on the surface of 12 Once it is turned on HOLD 70 5 sec the power on key functional key to enter into the menu interface PRESS lt 0 5 sec to scroll through options while HOLD 0 5 sec to select an item indicates the option you are curr
17. the sensor 5 Poor circulation can affect oximeter readings Warm your hands and fingers before taking your measurements Remember your pulse oximeter is measuring your SpO2 and 14 the instrument Caution Do not allow liquid to flow into the instrument during cleaning Caution Do not immerse any part of the instrument into any liquid 4 2 Disinfection Before measurement with the instrument wipe the silicon finger pad using a piece of dry soft cloth dipped with 75 medical alcohol Clean the finger to be measured using the medical alcohol for disinfection purposes before and after use A Do not disinfect the instrument by using high temperature high pressure disinfecting gas Chapter 5 Maintenance and Troubleshooting 5 1 5 2 Possible Cause Maintenance Replace the batteries if they are low on power Clean the Oximeter and the fingertip before use to ensure accurate reading Remove the batteries from the battery slot and properly store them if you do not plan to use the Oximeter for a long period of time Store the Oximeter between 14 122 F 10 to 50 C and at humidity levels no greater than 93 Periodically check the Oximeter for damage Avoid using the Oximeter in an environment with inflammable gases or using it in an environment where the temperature or humidity is excessively high or low Check the accuracy of the oxygen saturation and pulse rate readings by using an appropriate calibratio
18. to low or restricted blood flow Nail polish can also impede the pulse oximeter from taking a reading Finally it is generally accepted that the saturation percentage is unreliable on the steep part around 60 mm Hg of the oxyhemoglobin dissociation curve 2 6 Innovative features of the CMS 500D The CMS 500D attempts to ameliorate some of the above problems by 1 Increasing the sensitivity of the sensor so that it can measure the user s SpO2 and Pulse Rate PR even at low blood perfusion 2 Using a self adjusting smart spring system to fit the finger snugly but not so tight as to impede blood flow 3 Using soft hypoallergenic medical grade silicon in the finger chamber so that the pulse oximeter will not cause discomfort to your finger 4 Using solid ABS plastic to block ambient light from reaching the sensor so that the signal to background ratio and the accuracy of the measurement is dramatically increased 5 Having a plethysmograph that allows the user to see and gauge the amount of blood detected by the pulse oximeter This will allow the user to know if the finger is properly inserted into the finger chamber and if the pulse oximeter is taking the measurements properly See Chapter 3 3 3 about the plethysmograph The Oximeter fails to display the blood oxygen saturation levels and or pulse rate The displayed value of the oxygen saturation or pulse rate fluctuates The finger is not placed properly between the sens
19. tting components of the Oximeter as that could cause harm andor potentially blind your eyes This device is not intended to diagnose or treat any medical condition or disease It is intended for non medical use in healthy people to monitor their pulse and blood 1 6 2 4 When the signal detected by the Oximeter is incomplete or weak the readings of the oxygen saturation and pulse rate on the screen of the Oximeter are and 6 2 5 The oxygen volume graph of the Oximeter has been normalized 6 2 6 Manufacturing date See the label Service life 5 years Note The functional tester shall not be used to evaluate the accuracy of the probe of the pulse Oximeter or the accuracy of the pulse oxygen monitor Note The pulse Oximeter has a specific calibration curve and is precise for the combination of the mainframe and probe of the pulse Oximeter If the functional tester can measure the portion of overall errors of the mainframe probe system of the Oximeter attributable to the mainframe of the Oximeter the functional tester can test the accuracy of a pulse Oximeter that duplicates the calibration curve Note The product is not suitable for continuous long term monitoring When the probe of the Oximeter fails the Oximeter displays and 6 3 Safety Type Anti electric shock type internal power supply device Anti electric shock degree BF type application part Running mode continuous working Waterproof grade IPX1
20. unattended with unit or lanyard Warning Do not throw the batteries into fire as that could cause an explosion Warning Do not attempt to charge the included batteries as that could cause leakage fire disaster or even explosion Dispose the used batteries in accordance to the local laws and regulations of your region Warning Do not use the Oximeter in an MRI or CT environment Caution Do not operate the Oximeter if it is wet Avoid moving the oximeter from a cold to a hot and humid environment Caution Install the batteries properly before powering on the Oximeter for normal use Please remove the batteries if you are not planning to use the Oximeter for a long time Caution Close the battery cover when the instrument is in use Symbol Conventions 1 3 W wen POC SpO2 Symbol of oxygen saturation bpmPR Symbol of pulse rate Manufacturer information including the name and address of the manufacturer Eg Temperature limitation When end users abandon this product they must send the product to the collection place for recycling Warnin Information that you must learn about possible harm of this 5 product to patients or medical staff parameter range the Oximeter gives an alert sound 7 Technical parameters Display range saturation 25 bpm to 250 bpm Oxygen 1 Resolution saturation 1 bpm Oxygen 2 70 to 100 Meisuremeni No requirement lt 69 2 bpm Oxygen Upper limit 50
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