PC – 66B/66H
Contents
1. 66 M key for entering into connecting status as shown in Figure 4 5 Note Make sure the provided USB data cable is well connected between the device and PC before uploading data 14 User Manual for Handheld Pulse Oximeter When you transmit data SpO2 and PR values to your computer please let the oximeter stay in connecting status Do the following operation by the instruction in Oximeter Data Manager User Manual The data uploading will be activated Figure 4 5 Connecting Status Screen 4 4 3 Default On the menu screen select Default and then short time press EY key for entering into default setting screen as shown in Figure 4 6 Press the Navigation W key to choose Yes or No and press mode OK key to confirm or exit Short time press power back key to return to the previous menu screen Are you sure to do default setting Yes No Figure 4 6 Default Setting Screen 15 User Manual for Handheld Pulse Oximeter 4 4 4 Language Selection gt In Simplified Chinese version on main menu screen select English and then short time press E key the display language changes to English gt In English version on main menu screen select Simplified Chinese and then short time press E key the display language changes to Simplified Chinese 4 4 5 Version E On the menu screen select VERSION and then press EY key for entering into version screen as2. patient type should be selected there are two options ADU amp for adult and NEO for neonate gt SpO2Lo Limit SpO2 low limit setting range 5 0 99 the step is 1 The factory default value for adult is 90 and 85 for neonate gt PR Hi Limit High limit setting of pulse rate range 100 240bpm From 100 to 150 the step is 1bpm and from 150 to 240 the step is 5bpm The factory default value for adult is 120bpm and 160bpm for neonate gt PR Lo Limit Low limit setting of pulse rate range 30 99bpm and the step is lbpm The factory default 12 User Manual for Handheld Pulse Oximeter value for adult is 50bpm and 60bpm for neonate gt Date Date setting 1 When cursor stays on the Year of the date press Ei Mode OK key to active Year option the cursor flashes on the Year of the date 2 Press A Y Navigation key to adjust year 3 Press Power back key or EY Mode OK key to confirm and exit from date setting 4 The procedures of adjusting Month value and Day value are the same with Year adjustment Date Format yy mm dd Note The setting operations of other parameters such as TIME PATIENT RECORDING INTERVAL POWER SAVING etc are the same with date setting gt Time Time setting gt Recording Time interval for recording data SpO2 amp PR there are five options 1s 2s 4s 8s and OFF 1 Is the least length of data record is set to 30 seconds an
3. shown in Figure 4 7 Version 1 1 1 1 EC Figure 4 7 4 5 Data Recall On the default display screen longtime press DR Recall mute key to enter into record list display screen 16 User Manual for Handheld Pulse Oximeter 2013 01 09 12 09 35 2013 01 09 15 07 35 2013 01 09 10 03 35 2013 01 09 12 30 35 Figure 4 8 Record List 17 User Manual for Handheld Pulse Oximeter 4 5 1 Data Recall Choose record in the record list then press EY mode OK key the display screen will display trend graph as shown in Figure 4 9A Recording interval SpO Trend graph PR ordinate PR Trend graph Figure 4 9A Trend Graph Display Screen Operation Instructions Short time press Bf mode OK key to shift the trend graph screens as shown in Figure 4 9A Figure 4 9B and Figure 4 9C Short time press power back key to return to record list screen SpO t 100 12 50 35 2S PR Figure 4 9B Trend Graph Display Screen 18 User Manual for Handheld Pulse Oximeter spo 12 50 35 2s Figure 4 9C Trend Graph Display Screen 4 5 2 Data Deletion On the menu screen longtime press Kl key and the records list will appear At this time longtime pressing AX key again an message Are you sure to delete all prompts on the screen as shown in Figure 4 10 Are you sure to delete all Yes No Figure 4 10 At this time press W navigation key to select Ye
4. Peier R E EEEE 10 doD Recas ET AECE 16 5 Technical Specifications cccccccccssccssscssssssssssssssssses 20 6 Over limit Indication essssssssoccocccccccesssoosoococeecesseessssososeo 22 Gl Amit Senos aa a 22 6 2 Alert sound mute Setting ceccccccccccccceeceeeeeeeeeeeeseeees 22 TACCESSOFTE Sossarna aa a a aaa 23 8 Repair and Maintenance ccccccccccssscssscssscsssssscscscscccees 24 5 1 M mmenante sie NTT Erp Aeon a NC Pen Seen 24 8 2 Cleaning and Disinfecting Instruction eee 24 9 TroubleshO OU Osc icici sceccccccascaselesseasensesdsecusinsiaasabecxtacveasscesese 25 AWD GING sisena rana E A 26 User Manual for Handheld Pulse Oximeter 1 Overview 1 1 Appearance Data interface Display Key os p k Navigation knob ower Bac Mode OK Recall Mute SpO2 probe connector Figure 1 1 1 Display screen display SpO2 plethysmogram and parameter values 2 Navigation key A Up Left Increase User Manual for Handheld Pulse Oximeter Press this key the default screen can be shifted to display pulse rate PR or perfusion index PI If on the system setup screen press it to move the cursor upwards or to the left and adjust parameter values V Down Right Decrease Its function is similar with the key A Up Left Increase 3 EY Mode OK press this key the screen can be shifted between default screen display and alternative screen display longtime press it the menu scree
5. User Manual for Handheld Pulse Oximeter Instructions to User Dear Customer Thank you for purchasing this quality product Please read the manual very carefully before using this device Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter No part of this manual may be photocopied reproduced or translated into another language without the prior written consent We reserve the right to revise and amend it at any time without prior notice Version of the Manual Ver 1 2 Issued Date September 29 2014 All rights reserved Notes The contents contained in this manual are subject to change without prior notice Information furnished by Creative is believed to be accurate and reliable However no responsibility is assumed by Creative for its use or any infringements of patents or other rights of third parties that may result from its use 3502 2490003 User Manual for Handheld Pulse Oximeter Instructions for Safe Operation Check the device to make sure that there is no visible damage that may affect user s safety and measurement performance It is recommended that the device should be inspected minimally before each use If there is obvious damage stop using the device Necessary service must be performed only by qualified technicians Users are not permitted to service this device The oximeter must not be used with the devices and accessories not spe
6. cified in User Manual Cautions Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the Patient is under MRI or CT scanning This device is NOT MRI Compatible Warnings Discomfortable or pain may occur if using the sensor of this device continuously on the same location for a long time especially for the patients with poor microcirculation It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours or less if any abnormal condition is found Frequently check and re position the Oximeter I For the individual patients there should be a more IZ User Manual for Handheld Pulse Oximeter prudent inspecting in the placing process The sensor can not be placed on the edema and tender tissue The local law should be followed when disposing of the expired device or its accessories Attentions A A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture If the Oximeter gets wet please stop operating it and do not resume operation until it is dry and checked for correct operation When it is carried from a cold environment to a warm and humid environment please do not use it immediately Allow at least 15 minutes for the Oximeter to reach ambient temperature DO NOT operate the button on the f
7. d the maximal length for one record is limited to hour The total storage time is up to 48 hours 2 2s the least length of data record is set to 60 seconds and the maximal length for one record is limited to 2 hours The total storage time is up to 96 hours 3 4s the least length of data record is set to 120 seconds 13 User Manual for Handheld Pulse Oximeter and the maximal length for one record is limited to 4 hours The total storage time is up to 192 hours 4 8s the least length of data record is set to 240 seconds and the maximal length for one record is limited to 8 hours The total storage time is up to 384 hours 5 When the option is set to OFF the device will not store the gt measuring data Power saving power saving setting two options on and off The factory default setting is on If the power saving mode is on during measurement and there is no key operation for 2 minutes the screen display will be dim for power saving The display brightness will resume to normal condition by pressing any key Volume optional 3 levels setting 1 2 and 3 corresponding to the speaker volume icons of De Q and Q respectively The speaker volume icon indicates the volume of any sound generated by the device for key clicks over limit alerting pulse beep and audible probe off indication etc 4 4 2 Upload Data On the menu screen select UPLOAD DATA and then press
8. dicator Pulse rate mark Temory full icon SpO2 mark Pulse rate SpO2 Value symbol Pulse rate Value Pulse strength bar graph Plethysmogram Sound indicator Curent time the current low limit of Patient type SpO2 vallue is 99 Figure 4 1 Default Screen Description i Cl Memory full icon if the memory is full the memory full icon 7 appears on the screen No display of this icon means the current storing space is not full If the memory is full the data storing will continue in such way the new record will overwrite the oldest record so that it s recommended to upload the stored data into the computer in time During the measurement short time press recall mute IK key to turn off or resume the pulse beep sound while the pulse symbol still blinks For alert sound mute function refer to Section 6 2 for detail Note The pitch tone of pulse beep dididi is modulated by the SpO2 value that means the pitch tone changes when the measured SpO2 changes The higher the SpO gt value is the User Manual for Handheld Pulse Oximeter higher the tone frequency of pulse beep sound becomes sharper The lower the SpOz value is the lower the tone frequency of pulse beep sound becomes flatter 4 3 Display Screen with PI Value On the default display screen press A V Navigation key to shift screens between default screen and display screen with PI value The display screen with PI value is
9. ich is wrapped with a cuff for blood pressure measurement or during venous infusion User Manual for Handheld Pulse Oximeter 5 Do not let anything block the emitting light from the sensor Vigorous exercise and electrosurgical device interference may affect the measuring accuracy Using enamel or other makeup on the nail may affect the measuring accuracy If the first reading appears with poor waveform irregular or not smooth then the reading is unlikely true the more stable value is expected by waiting for a while or a re inserting finger is needed when necessary User Manual for Handheld Pulse Oximeter 4 Operation 4 1 Power on off the Oximeter gt When the device is off press power back key for 2 seconds to power up the Oximeter then it will enter into measurement display screen gt Ifthe Oximeter is working longtime press power back key to power it off gt During measurement if the probe off is detected for longer than one minute then the device will power off automatically gt If not in the measurement state and there is no any key operation for 1 minute the device will power off automatically as well 4 2 Default Display Screen Press power key for 2 seconds to start up the Oximeter then insert the finger into the rubber cushions of the probe the screen will display the default screen as shown in Figure 4 1 User Manual for Handheld Pulse Oximeter battery in
10. ient type 26 User Manual for Handheld Pulse Oximeter SpO2 probe connector Power Back Key Mode OK Key LA eame O Date of manufacture EGIREP Authorised representative in the European community gt C ol Manufacturer including address With Type BF applied part See User Manual R Disposal of this device according to WEFE regulations 27 User Manual for Handheld Pulse Oximeter Common Knowledge 1 Meaning of SpO2 SpO gt is the saturation percentage of oxygen in the blood so called O2 concentration in the blood it is defined by the percentage of oxyhemoglobin HbO2 in the total hemoglobin of the arterial blood SpO2 is an important physiological parameter to reflect the respiration function it is calculated by the following method SpO2 HbO2 HbO2 Hb x100 HbO are the oxyhemoglobins oxygenized hemoglobin Hb are those hemoglobins which release oxygen 2 Principle of Measurement Based on Lamber Beer law the light absorbance of a given substance is directly proportional with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO2 and deoxygenated hemoglobin Hb have different absorption character in the spectrum ra
11. ive illumination such as surgical 29 lt gt User Manual for Handheld Pulse Oximeter lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight Vascular dyes or external used color up product such as nail enamel or color skin care Excessive patient movement Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line Exposure to the chamber with High pressure oxygen There is an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing 5 Factors causing low SpO gt value pathology reason lt gt gt gt gt Hypoxemia disease functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough 30
12. n the display screen The alert sound starts interval is 5 seconds and lasts for about minute If the probe is still off the Oximeter will power off automatically 22 User Manual for Handheld Pulse Oximeter 7 Accessories A probe A holder Battery AA x3 Charging cable optional User Manual Quality Inspection Certificate A data cable optional Ce ty ee ee R Oximeter Data Manager software optional Note The accessories are subject to change See the Packing List for detailed items and quantity 23 User Manual for Handheld Pulse Oximeter 8 Repair and Maintenance 8 1 Maintenance The expected service life not a warranty of this device is 5 years In order to ensure its long service life please pay attention to the maintenance e Please change the batteries when the low voltage indicator appears e Please take out the batteries if the oximeter will not be used for a long time e The recommended storage environment of the device Ambient temperature 20 C 60 C Relative humidity 10 95 Atmospheric pressure 5 0kPa 107 4kPa e The oximeter is calibrated in the factory before sale there is no need to calibrate it during its life cycle However if it is necessary to verify its accuracy routinely the user can do the verification by means of SpO2 simulator or it can be done by the local third party test house 8 2 Cleaning and Disinfecting Instruction e Surface clean sensor with a soft clo
13. n will be displayed when you finish parameter setting press this key to confirm 4 Data interface used for uploading data Optional function 5 O DC power input used for connecting external DC power input for recharging the built in rechargeable battery 6 o Power Back Power on off the device by longtime pressing short time press it to back to the previous level of menu while setting menu operation P X Recall Mute Longtime press it to enter SpO2 trend data recall screen when the device is beeping short time pressing will mute the indication sound the mute state will persist for about 90s After this mute period 90s then the indication sound will resume 8 Icon SpO 2 SpO2 Probe Connector 1 2 Product Name and Model Name Handheld Pulse Oximeter 2 User Manual for Handheld Pulse Oximeter Model PC 66B 1 3 Structure It consists of the main unit and SpO2 probe 1 4 Features lt gt gt gt gt gt gt lt gt It is lightweight small in size and easy to carry Color LCD to display plethysmogram and parameters Monitor SpO2 and Pulse Rate simultaneously PI Perfusion Index display is available Up to 384 hours storage and recall of SpO2 and PR data Audible and visual alert function is available Data transmission to PC for view and analysis Optional Power saving mode is available 1 5 Intended Use This Handheld Pulse Oximeter is intended for measuring and recording
14. nge from red to infrared light 600nm 1000nm wavelength by using these 28 User Manual for Handheld Pulse Oximeter characteristics SpO2 can be determined SpO2 measured by this oximeter is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpOz is an important physiological parameter to reflect the respiration and ventilation function so SpO2 monitoring used in clinical becomes more popularly such as monitoring the patient with serious respiratory disease the patient under anesthesia during operation premature and neonate The status of SpOz can be determined in time by measurement and find the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 3 Normal SpO2 Range and Default Low Limit In campagna area healthy people s SpO2 value is greater than 94 so the values below 94 are determined as hypoxia SpO2 lt 90 is considered as the default threshold for determining anoxia by most researchers so SpO2 low limit of the oximeter is set as 90 generally 4 Factors affecting SpO2 accuracy interference reason lt Intravascular dyes such as indocyanine green or methylene blue lt Exposure to excess
15. ower from PC or DC adapter When the display screen appears the rolling icon EEE it means the battery is charging When the screen shows icon ME it means the battery is fully charged Pulling out the charging cable then the above icon will disappear Safety instruction for operation Do not throw the battery into the water liquid and fire Keep the battery out of the reach of the child Do not disassemble the battery Please remove the battery and put it to specified condition if the device will not be used for a long time If the battery is damaged please replace it with the same model AA alkaline battery or lithium battery provided by the same manufacturer User Manual for Handheld Pulse Oximeter A In order to prolong the lithium battery s using life please pay attention to the battery maintenance 3 SpO2 Probe Connection Connect the SpO2 probe to the connector labeled SpO at the right side of the Oximeter After starting up the Oximeter insert one finger index finger middle finger or ring finger with proper nail length into the probe according to the demonstration shown in the following figure Figure 3 1 Demonstration for Using SpO2 probe finger clip Instructions of Operation 1 The finger should be put in properly and correctly 2 Do not shake the finger and keep at ease during measurement 3 Do not put wet finger directly into sensor 4 Avoid placing the sensor on the same limb wh
16. ront panel with sharp materials or sharp point DO NOT use high temperature or high pressure steam disinfection on the oximeter and probes Refer to related chapter for instructions regarding cleaning and disinfection The intended use of this device is not for therapy purpose Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 ISO 9919 2009 ISO 80601 2 61 2011 M User Manual for Handheld Pulse Oximeter and follows the provisions of the council directive MDD93 42 EEC Caution U S federal law restricts this device to sale or use by or on the order of a physician IV User Manual for Handheld Pulse Oximeter Table of Contents TOV ORVICW PEE E E E E savercuectovaledssdeiesuseatetsenees 1 LEADPPeA ANC a dens l 1 2 Product Name and Model ccccccssssesseeeeeeeeceeeeeeeees 2 Lo SCUO na E sues 3 LATEA eSa O 3 PD intended U SC eases aceuatetieteineatatess lance edad terdens ceacdclowttetonctas 3 LO Workin Environments 3 2 Installation of Battery and Holdev sssssssssssssssssees 4 3 SpO2 Probe Connection cccssssssssssssssssssssssssssssssssssssssscecees 6 A ODOT AU OM asses AEE A E AE aaa 8 4 1 Power on off the Oximetel cc cc ssessessseeecceeeeeeeeeeeeeees 8 4 2 Default Display Screen iicoccversecscrnccsiariaaviaudavevetannnscets 8 4 3 Display Screen with PI Value eeeeeeeeeeeeeeeeees 10 Aish INV ME SC EU
17. s or g I99 No and press mode OK key to confirm or exit Or short nf n time press power back key to return to record list screen 19 User Manual for Handheld Pulse Oximeter 5 Technical Specifications A Display Mode Color dot matrix LCD B Power Supply Supply voltage d c 4 5V 3 AA alkaline batteries or d c 3 6V Lithium rechargeable battery Operating current lt 180mA C SpO2 Measurement Transducer dual wavelength LED sensor with wavelength Red light 663 nm Infrared light 890 nm Maximal optical output power lt 2mW maximum average Measuring range 35 100 Measuring accuracy Not greater than 3 for SpOz range from 70 to 100 NOTE Accuracy defined as root mean square value of deviation according to ISO 9919 Low limit setting range 5 0 99 Default setting 90 D Pulse Rate Measurement Measuring range 30bpm 240bpm Accuracy 2bpm or 2 whichever is greater Over limit setting range 25bpm 250bpm Default setting limit High 120bpm Low 50bpm E Perfusion Index Display Range 0 2 20 20 User Manual for Handheld Pulse Oximeter Data Update 8 beats moving average for both SpO2 and pulse rate readings Data Storage Recording SpO2 and pulse rate data every 1 2 4 8 second s up to 384 hour records can be stored Low Perfusion Performance The accuracy of SpO2 and PR measurement still meet the precision described above when the modulation amplitude is as lo
18. shown below SpO2 Cuil 99 14 PI y Perfusion index symbol Perfusion index Value 09 18 SpO02 gt 99 Figure 4 2 Display Screen with PI Value 4 4 Menu Setup On the above mentioned screens longtime press Ef key for entering into setup menu screen as shown in Figure 4 3 10 User Manual for Handheld Pulse Oximeter Menu Menu Setting Version Upload data Default fej PTH 3C Figure 4 3 Setup Menu Screen Screen Description gt gt gt Setting set parameter values refer to Chapter 4 4 1 for details Upload data enter into data uploading state refer to Chapter 4 4 2 for details Default enter into the factory default setting refer to Chapter 4 4 3 for details fay 48 A 30 this Oximeter provides the display with two languages English and aj fk 3 Simplified Chinese Version for viewing version number of the software refer to Chapter 4 4 5 for details 4 4 1 Setting On the menu screen select Setting and then press EY key for entering into system setup screen The setup screen is as shown in the following figures 11 User Manual for Handheld Pulse Oximeter Setting Patient Date 2013 01 09 SpO2 Lo Limit Time 10 12 45 PR Hi Limit Recording interval 1s PR Lo Limit Power saving ON Volume Figure 4 4 System Setup Screen Operation Instructions gt Patient according to the type of SpO2 probe the matched
19. th by wetting with a solution such as 75 isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution e Then surface clean by a dampened cloth and let it air dry or wipe it with a cloth High pressure disinfection cannot be used on the device Do not immerse the device in liquid 24 User Manual for Handheld Pulse Oximeter 9 Troubleshooting Trouble i Possible Reason i Solution 1 The finger is not ae eee 1 Place the finger ae _ correctly inside and try Unstable SpO and Pulse again _ 2 Reduce patient movement _ 2 The finger is _ shaking or the patient is moving Rate display i 1 The batteries are i drained or almost i drained i 1 Change batteries 2 The batteries are 2 Reinstall batteries i not inserted i 3 Please contact the properly local service center 3 The device is i malfunctioning Device will not switch on i 1 The device will i power off 2 _ automatically when i there is no signal i 1 Normal Display and no operation for 2 Change batteries i 1 minute i _2 The batteries are i almost drained 25 User Manual for Handheld Pulse Oximeter Appendix Key of Symbols YoSpO2 The oxygen saturation Symbols Perfusion Index nthe wbpm Pulse rate Unit beats per minute Pro Low battery voltage Battery fully charged icon screen D D Speaker volume icon gg Memory full Neonate Adult Pat
20. the pulse rate and functional oxygen saturation SpO2 It is applicable for monitoring SpO2 and pulse rate of adult and pediatric patients in clinical institutions and homes 1 6 Working Environment Operating temperature 5 40 C Operating humidity 30 80 Atmospheric pressure 70kPa 106kPa User Manual for Handheld Pulse Oximeter 2 Installation of Battery and Holder 1 Open the rear panel with coin or an ordinary flat screwdriver as shown in Figure 2 1 Figure 2 1 2 AA Alkaline batteries or Lithium battery optional If AA alkaline batteries non chargeable are provided then according to the polarity mark insert three AA batteries into battery house as shown in Figure 2 2 Figure 2 2 Figure 2 3 Fixing Holder 4 D peewee User Manual for Handheld Pulse Oximeter If Lithium battery rechargeable is provided place the lithium battery into the battery house and insert its terminal header into the corresponding connector in the battery compartment 3 Close the battery cover and lock it 4 Fixing Holder as shown in figure 2 3 Notes When the device is provided with AA alkaline batteries and it shows low battery the user should replace the batteries in time 2 When the device is provided with lithium battery and it shows low battery the user should recharge the battery in time That is connect one end of the charging cable to the device s DC power input and connect the other end to the USB p
21. w as 0 5 Resistance to interference of surrounding light The difference between the SpO2 value measured in the condition of indoor natural light and that of darkroom is less than 1 Dimensions 145 mm L x 74 mm W x 29 mm H Net Weight 210g including batteries Classification Type of protection against electric shock Internally powered equipment Degree of protection Type BF applied parts Degree of protection against harmful ingress of liquids Ordinary equipment without protection against ingress of water Electro Magnetic Compatibility Group I Class B 21 User Manual for Handheld Pulse Oximeter 6 Over limit Indication 6 1 Limit settings gt SpO gt 2 low limit setting range 50 99 gt Pulse Rate limits setting range High 100bpm 240bpm Low 30bpm 99bpm During the measurement if the measured value exceeds the preset value the alert beeping sound will be activated the value that is over limit will blink at the same time 6 2 Alert sound mute setting gt During the measurement if the alert sound is set to on short time press Xn recall mute key then the alert sound will mute for 90 seconds but the over limited value still keeps blinking At this moment the speaker volume icon becomes If this alert event persists over 90 seconds then the alert sound will be activated again gt During the measurement if the probe is off or disconnected the message Check Probe shows o
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