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tBPC oCare Pro100, Instructions For Use Manual

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Wrist-worn Pulse Oximeter

 

oCare

TM

 Pro 100 

 

Instructions for Use 

Ver.  P01A01-4

 

 

 
 
 
 
 
 
 
 
 
 
 
 

Summary of Contents for oCare Pro100

Page 1: ...Wrist worn Pulse Oximeter oCareTM Pro 100 Instructions for Use Ver P01A01 4...

Page 2: ...oCareTM Pro 100 2 MedNet GmbH Borkstrasse 10 48163 M nster Germany Tel 49 0 251 322 66 61 Fax 49 251 322 66 22 Email ear medneteurope com http www mednet eurep com...

Page 3: ...tBPC s oCareTM Wrist worn Pulse Oximeter Model Pro 100 2014 Taiwan Biophotonic Corporation All rights reserved tBPC oCareTM oCareTM Sensor and oCareTM Pro are registered trademarks or trademarks of T...

Page 4: ...relate to safety Please read the text carefully and use this device safely Indicate instructions related to actions Please follow instructions for use IP65 No ingress of dust complete protection agai...

Page 5: ...y of equipment marked with this symbol Mark Conformity to European Medical Device Directive 93 42 EEC Indicate authorized representative in the European Community Serial number The container can and s...

Page 6: ...itivity varies depending on medical status or skin condition 3 Do not use the device for measurement while the watch case is taken off from the watchband for charging purpose 4 Avoid excessive pressur...

Page 7: ...40 C please stop using the device and seek medical attention immediately 12 Do not use the oCareTM Pro 100 and perform PR SpO2 measurement within 48 hours after receiving the photodynamic therapy to...

Page 8: ...garding EMC and all equipment must be installed and put into service according to the EMC information specified in this manual 15 During measurement do not take off the device and apply the sensor por...

Page 9: ...safe for skin and washable surfaces Most detergents can be high sudsing so use sparingly Wipe with a damp detergent free cloth to remove residue 6 A functional tester cannot be used to assess the accu...

Page 10: ...ssure cuffs infusion lines etc anemia or low hemoglobin concentrations improperly applied this device poor pulse quality cardiogreen and other intravascular dyes carboxyhemoglobin methemoglobin dysfun...

Page 11: ...ent s wrist Inaccurate readings and patient discomfort could result 15 To avoid the risk of confusing or misinterpreting patient data when transmitting data via BLUETOOTH verify the device is paired w...

Page 12: ...e that may cause undesired operation Federal Communications Commission FCC Notice This device has been tested and found to comply with the limits for a class B digital device pursuant to part 15 of th...

Page 13: ...nt This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment End users must follow the specific operating instructions for satisfying RF exposure compliance...

Page 14: ...oCareTM Pro 100 14 NCC...

Page 15: ...Conformity with FCC for Electromagnetic Compatibility 12 Federal Communications Commission FCC Notice 12 NCC 14 Contents 15 List of Figures 19 List of Tables 20 1 Introduction 21 Intended Use 21 Hardw...

Page 16: ...ng the Watchband Length 37 Wearing the oCareTM Pro 100 39 Taking off the oCareTM Pro 100 40 Startup Sequence and Self Test 41 Date and Time Setting 42 3 Operation and Measurements 44 Device Activation...

Page 17: ...Brightness Setting 54 Date Time Setting 54 Idle Time to Sleep Setting 54 About the device 55 Exit 55 Data Transmission 55 Device Shut Down 57 4 Alarm 58 Alarm Indication 58 Alarm Limit 58 5 Care and...

Page 18: ...cifications 72 Performance 72 System 73 Electrical 73 Physical Characteristics 74 Environmental Condition 75 Compliance 75 Alarm 76 Wireless Transmitter 77 Displayed Values 78 SpO2 78 Pulse Rate 78 Pr...

Page 19: ...w 22 Figure 2 Detach the Watchband 32 Figure 3 Battery Charge 35 Figure 4 Attach the Watchband 36 Figure 5 Adjustment of Watchband Length 38 Figure 6 Wearing the oCareTM Pro 100 39 Figure 7 Taking off...

Page 20: ...ALARM INDICATOR 58 Table 4 Physiological Alarm Medium Priority 58 Table 5 Technical Alarm Low Priority 58 Table 6 Troubleshooting 66 Table 7 Recommended Separation Distances 82 Table 8 Electromagneti...

Page 21: ...se in noninvasive measuring displaying and storing functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate PR The intended measuring site of this device is the wrist skin surface It is...

Page 22: ...00 22 Hardware Overview 1 Watch Case 2 Watchband 3 SWITCH Button 4 ENTER Button 5 LED Alarm indicator 6 Metal Watch Clasp 7 PR SpO2 Sensor Port 8 Thermal Sensor Port 9 Micro USB AB Port Figure 1 Hardw...

Page 23: ...e 2 Display Symbols and Notations Watch Mode Display Hour Notation The blue dot indicates the Hour of the time Minute Notation The blue square bar indicates the Minute of the time Second Notation The...

Page 24: ...battery is 3 25 Battery is charging When remaining battery is less than 25 the battery symbol flashes When remaining battery is less than 10 the device shuts down automatically to preserve the Date Ti...

Page 25: ...splay This 3 digit display shows the pulse rate in beats per minute bpm The displayed range is from 40 to 240 bpm Heart sign is added to facilitate the differentiation between pulse rate and SpO2 valu...

Page 26: ...r rises and falls with the monitored pulse rate Pulse Search Indicator The dashes are displayed until the measurement readings are stabilized No Motion Symbol This symbol indicates excessive movement...

Page 27: ...is ON and is also displayed in the lower right corner of the display Setting Symbol Enter the SETTING menu MESSAGE Display Caution Message Symbol When a caution message is generated poor signal condi...

Page 28: ...vice receives a BLUETOOTH pairing request from another master device A 6 digit passkey is randomly generated and displayed below BLUETOOTH Link Symbol When BLUETOOTH link is established the symbol is...

Page 29: ...number and device software number Exit Symbol Return to previous mode Unpacking the oCareTM Pro 100 The oCareTM Pro 100 standard kit includes the items listed below Once the shipping carton is unpack...

Page 30: ...ailed battery life information The battery symbol shows one of four states 100 75 50 and 25 full Recharge the device when remaining battery is lower than 25 When remaining battery is less than 25 The...

Page 31: ...OOTH radio to a compatible BLUETOOTH enabled device tBPC s wireless system removes the cable connection from the device giving patients increased ability to move freely To make efficient use of batter...

Page 32: ...0 Charging the Battery Detach the Watchband 1 Pinch the watch case with one hand and pull the other side of the watchband with another hand 2 Separate the watch case with the watchband as illustrated...

Page 33: ...ro USB AB port of your oCareTM Pro 100 as illustrated in Figure 3 4 While in charging LED INDICATOR flashes WHITE every 5 seconds to indicate charging status stays WHITE constant ON to indicate batter...

Page 34: ...y environmental ESD This is an ESD self protection of the product and oCareTM Pro 100 will not affect its intended function The user does not need to concern about it 5 The power adaptor may be affect...

Page 35: ...Taiwan Biophotonic Corporation 35 Figure 3 Battery Charge...

Page 36: ...aining battery is greater than 25 Attach the Watchband 1 Plug the anti ESD Electrostatic discharge cover to the micro USB AB port on the watch case 2 Align the watch case with the watchband as illustr...

Page 37: ...clasp in one of the adjustment holes and it is this end that will be worked on 3 Pull the watchband from the clasp to remove the pin from the adjustment hole Move the pin to desired adjustment hole a...

Page 38: ...oCareTM Pro 100 38 Figure 5 Adjustment of Watchband Length...

Page 39: ...he oCareTM Pro 100 1 The oCareTM Pro 100 is worn on the back of the hand slightly above the wrist bone ulnar styloid processus as illustrated in Figure 6 to provide the best comfort and measurement ac...

Page 40: ...00 40 Taking off the oCareTM Pro 100 1 Pinch the pins on both sides of the metal watch clasp as illustrated in Figure 7 2 Pull the metal watch clasp and take off the device Figure 7 Taking off the oCa...

Page 41: ...lowing action sequences are performed Vibrate for 1 seconds The LED INDICATOR flashes YELLOW one time The LED INDICATOR flashes BLUE one time LED INDICATOR flashes WHITE three times The display shows...

Page 42: ...changing color of Year into yellow 1 1 2 Press SWITCH button to select the current Year up to 2099 long press to speed up the selection press ENTER button to accept the setting and move to Month setti...

Page 43: ...hour long press to speed up the selection press ENTER button to accept the setting and move to Minute setting 2 2 Minute second setting repeat the same procedure above Minute default 00 second default...

Page 44: ...Press ENTER buttons for 3 seconds to turn on the device Sleep Mode When the criteria of Sleep Mode is met after the ex no activity in 3 minutes the Sleep Mode is activated according to the setting of...

Page 45: ...ressed in designated time the device enters Sleep Mode 3 Press SWITCH button once to enter the Measurement Mode whenever needed Measurement Mode The mode is for the monitoring of Pulse Rate PR and blo...

Page 46: ...the setting there 2 1 4 If no button is pressed in designated time the device enters Sleep Mode 2 2 Continuous Monitoring for longer period of monitoring 2 2 1 Activate the continuous monitoring func...

Page 47: ...2 2 5 To wake up from Sleep Mode press any button once to turn on the display in Continuous Monitoring 2 2 6 To stop the continuous monitoring go to CONTROL and deactivate the continuous monitoring 2...

Page 48: ...ity alarm is activated refer to Table 4 for details Address the patient condition immediately The PR SpO2 number on the display turns YELLOW The device takes the measurement continually until the medi...

Page 49: ...racy NOTE 1 The device measures collects and stores up to 72 hours of SpO2 and pulse rate data with a 1 second data collection rate 2 When the memory is full the device overwrites the oldest existing...

Page 50: ...the target symbol the color of the unselected one turn dark and 2 1 Return 2 1 1 Press ENTER button to return to previous MODE 2 2 BLUETOOTH 2 2 1 Press ENTER button to activate deactivate the BLUETO...

Page 51: ...directly 2 There are two types of messages Poor Signal Condition Suggest the user to adjust the device position as illustrated in Figure 8 for better signal reading Malfunction Refer the user to Troub...

Page 52: ...n to select the target symbol the color of the selected symbol would change and press ENTER button to enter the lower menu PR SpO2 Limit Setting RESET ON OFF Press ENTER button to switch to SpO2 high...

Page 53: ...2 high limit and press ENTER button to accept the setting and move to SpO2 low limit setting 2 Repeat the same process above for SpO2 low limit PR high limit and PR low limit 3 Once the PR low limit i...

Page 54: ...n to SETTING menu Date Time Setting Please refer to Date and Time Setting for adjustment instrucitons Idle Time to Sleep Setting If longer observation of the measurement value is required adjust the s...

Page 55: ...return to upper menu About the Device The screen displays the model number software version and serial number Press ENTER button to go back to SETTING menu Exit Press ENTER button to return to Watch...

Page 56: ...mpted with BLUETOOTH pairing request from other master device within 10 m radius the device generates a random 6 digit passkey on the display 3 Enter the 6 digit passkey into the other BLUETOOTH maste...

Page 57: ...ster devices are memorized for quick BLUETOOTH connection 3 The BLUETOOTH master device and oCareTM Pro 100 shall stay within 10 meter radius range during BLUETOOTH connection 4 The BLUETOOTH master d...

Page 58: ...stics of ALARM INDICATOR Alarm Priority Color Flashing Frequency Medium YELLOW 0 4Hz Low BLUE Constant ON Alarm Limits Two types of alarm are present physiological and technical refer to Table 4 and T...

Page 59: ...ting below the newly entered high limit setting 2 When default alarm setting is changed a decimal point is displayed after the reading as a reminder 3 When PR SpO2 high or low limit is exceeded Medium...

Page 60: ...limit before consulting the medical advice 3 Alarm condition physiological and technical alarm limits date time of occurrence are saved in non volatile memory The alarm data is kept intact during powe...

Page 61: ...se recommended here as permanent damage could result Dry with a soft cloth or allow to air dry Clean once per week or more frequently if worn by multiple users Cleaning the Watchband Wipe the Watchban...

Page 62: ...oCareTM Pro 100 62 Storing Store the device within the stated environmental conditions See Specifications section for additional information...

Page 63: ...u have to contact tBPC with technical service issues or if you have any questions regarding the use or performance of your pulse oximeter A return material authorization RMA number is required before...

Page 64: ...l be handled by the distributor of tBPC for the geographic area where the purchase was made A return shipping and handling fee may be applied for all returns As a condition of this Warranty the warran...

Page 65: ...eplace materials or components tBPC makes no other express or implied warranties arising by operation of law or otherwise or any warranty of merchantability or fitness for a particular use or purpose...

Page 66: ...use Possible Solution No PR SpO2 value Premature determination of malfunction If no PR SpO2 value shown in 25 seconds follow the troubleshooting below for solution Wrist skin is cold Warm or rub the d...

Page 67: ...ent Tattoo or hairy hairs under the device measurement site Make sure the device measurement site is free of tattoo or hairy hairs Possible interference from blood flow restrictors arterial catheters...

Page 68: ...rn lower arm HORIZONTAL and STILL while taking the measurement Battery symbol flashes Battery is low Charge the device as illustrated in Figure 3 ALARM INDICATOR flashes YELLOW Medium priority alarm i...

Page 69: ...Hardware malfunction detected Press ENTER buttons for 3 seconds to shut down the device If the error message persists after reboot contact local distributor for assistance Device is not responding So...

Page 70: ...ement Remaining battery is less than 10 Charge the battery full and then enter the continuous recording Devices can t pair Device is out of BLUETOOTH range Verify device is in BLUETOOTH range while be...

Page 71: ...ce automatically shuts down Battery is depleted Charge the device as illustrated in Figure 3 Device battery runs out quickly Idle Time to Sleep is set to Never Change the Idle Time to Sleep setting in...

Page 72: ...red 940 nm 1 7 mW maximum Oxygen Saturation Display Range 0 100 SpO2 Pulse Rate Display Range Beats Minute 40 240 bpm Oxygen Saturation Accuracy Oxygen Saturation Measuring Range Non motion 70 100 SpO...

Page 73: ...p to 72 hours one second interval Electrical Power Supply Input DC 5V 400 mAh Lithium Ion Polymer Rechargeable Battery Battery Charging Port Micro USB AB Type Charging time 3 hrs Power Consumption App...

Page 74: ...ch Case Watchband Polycarbonate Thermoplastic Silicone Vulcanizate Enclosure Degree of Ingress Protection IP65 No ingress of dust complete protection against contact dust tight Water projected by a no...

Page 75: ...essure range of 760 hPa to 1 060 hPa altitude 0 3 000m Storage Transportation Condition A temperature range of 40 C to 70 C 40 F to 158 F A relative humidity range of 5 to 95 non condensing 40 C 40 F...

Page 76: ...Alarm Type Low Battery Malfunction Poor Signal Condition High Low SpO2 PR High Low SpO2 PR alarm range SpO2 high limit 86 100 SpO2 SpO2 low limit 85 95 SpO2 PR high limit 75 250 bpm PR low limit 40 11...

Page 77: ...eration Slave Antenna Type Internal Modulation Type Frequency Shift Keying Frequency Hopping Spread Spectrum Band Width 1 MHz NOTE 1 The device has been validated for no motion accuracy in human clini...

Page 78: ...od to measure the functional oxygen saturation in the blood More specifically it measures the amount of oxygenated hemoglobin as percentage of functional hemoglobin including oxygenated hemoglobin HbO...

Page 79: ...lar bed of the tissue The arteriolar bed absorbs variable amounts of light during the pulsations Changes in light absorption during the pulsing cycle are measured by the PDs as scattered lights are re...

Page 80: ...de and reflectance mode The transmission oximetry sensor is configured with LED and PD positioned on opposing surfaces of the tissue i e finger earlobe then the PD detects predominantly forward scatte...

Page 81: ...1 1 2 2014 The oCareTM Pro 100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the oCareTM Pro 100 can help prevent electromagnetic i...

Page 82: ...etween portable and mobile RF communication equipment transmitters and the device as recommended below according to maximum output power of the communications equipment Separation Distance According t...

Page 83: ...g of the transmitter in watts W according to the transmitter manufacturer NOTES 1 At 80 MHz and 800 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromag...

Page 84: ...ns CISPR 11 Group 2 This oCareTM Pro 100 must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF Emissions CISPR 11 Class B The oCareT...

Page 85: ...ance Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material relative humid...

Page 86: ...ip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds N A Mains power quality should be that of a typical commercial or hospital environment Power Frequency 50 60Hz Ma...

Page 87: ...Taiwan Biophotonic Corporation 87 NOTE UT is the AC mains voltage before application of the test level...

Page 88: ...ed no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Immunity Test IEC 60601 Tes...

Page 89: ...termined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the symbol NOTES 1 At 80 M...

Page 90: ...ent due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the oCareTM Pro 100 is used exceeds the applicable RF compl...

Page 91: ...our local distributor or tBPC at 886 3 667 0888 This information is also available on tBPC s website www tbpchc com PART NAME Watchband Large Black fits 165 205cm wrists Watchband Large White fits 165...

Page 92: ...oCareTM Pro 100 92 Note...

Page 93: ...Taiwan Biophotonic Corporation 93 Note...

Page 94: ...oCareTM Pro 100 94 Note...

Page 95: ...Taiwan Biophotonic Corporation 95 Note...

Page 96: ...nty 30261 Taiwan Tel No 886 3 667 0888 Fax No 886 3 667 0222 E mail serv tbpchc com Website www tbpchc com Ver P01A01 4 oCare is a registered trademark of Taiwan Biophotonic Co Taiwan Patent No I47775...

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