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Operator’s Manual

Model 3150

WristOx

2

®

 Pulse Oximeter

BLE and USB

0123

English

Содержание WristOx2 3150

Страница 1: ...Operator s Manual Model 3150 WristOx2 Pulse Oximeter BLE and USB 0123 English ...

Страница 2: ... Service GmbH Borngasse 20 D 35619 Braunfels Germany References to Nonin in this manual imply Nonin Medical Inc Nonin WristOx2 PureLight nVISION FlexiWrap and Flexi Form are registered trademarks or trademarks of Nonin Medical Inc The Bluetooth word mark and logo are owned by the Bluetooth SIG Inc and any use of such marks by Nonin Medical Inc is under license Other trademarks and trade names are ...

Страница 3: ...y 3150 BLE only 11 Modes 12 Activation Modes 12 Spot Check Activation Mode 12 Sensor Activation Mode 12 Programmed Activation Mode 12 Display Modes 13 Full Display Mode 13 Partial Display Mode 13 Memory Volume MVI Display Mode 13 Using the WristOx2 Model 3150 15 Installing Batteries 15 Attaching the Wristband 16 Wristband Description 16 Attaching the Sensor 22 Patient Application 23 Verifying Oper...

Страница 4: ...reless Technology Information 38 Connecting the Device into a Medical System 38 Parts and Accessories 40 Sensors 40 Service Support and Warranty 42 Service and Support 42 Warranty 42 Technical Information 43 Manufacturer s Declaration 43 Essential Performance 43 Equipment Response Time 45 Testing Summary 46 SpO2 Accuracy Testing 46 Pulse Rate Motion Testing 46 Low Perfusion Testing 46 Principles o...

Страница 5: ...Figure 9 Device with Multiple Use Wristband Attached Front and Back Views 19 Figure 10 Single Use Wristband 20 Figure 11 Device with Single Use Wristband Attached 21 Figure 12 Attach Sensor 22 Figure 13 Thread and Tighten Wristband 23 Figure 14 Fasten Wristband 24 Figure 15 Using the Rectangle Fastener 24 Figure 16 Using the Square Fastener 25 Figure 17 Attach Single Use Wristband 26 Figure 18 Rem...

Страница 6: ...iv Tables Table 1 Labeling Symbols 5 Table 2 Error Codes 29 Table 3 Electromagnetic Emissions 43 Table 4 Electromagnetic Immunity 44 Table 5 Not Applicable 44 ...

Страница 7: ...n pulse oximeters Using other manufacturers sensors can result in improper pulse oximeter performance To prevent improper performance and or patient injury verify compatibility of the monitor sensor s and accessories before use No modifications to this device are allowed as it may affect device performance The USB cable must be unplugged from the device before replacing batteries Before changing t...

Страница 8: ...g instructions regarding disposal or recycling of the device and device components including batteries In compliance with the European Directive on Waste Electrical and Electronic Equipment WEEE 2002 96 EC do not dispose of this product as unsorted municipal waste This device contains WEEE materials please contact your distributor regarding take back or recycling of the device If you are unsure ho...

Страница 9: ...device will be stored for more than 30 days Do not use different types of batteries at the same time Do not mix fully charged and partially charged batteries at the same time These actions may cause the batteries to leak To avoid the risk of confusing or misinterpreting patient data when transmitting data via Bluetooth verify the device is paired with the correct display unit The pulse oximeter ma...

Страница 10: ...te FCC RF exposure guidelines and should be avoided The WristOx2 Model 3150 is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energy set by the United States FCC These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population The guidelines are based on the safety standards previously set by bo...

Страница 11: ...ient isolation from electrical shock No alarms Indicates separate collection for electrical and electronic equipment WEEE Continua Certified signifies that this product has been tested and proven to be interoperable with other products that carry the Continua Certified symbol BLE only Bluetooth figure mark BLE only Non ionizing electromagnetic radiation Equipment includes RF transmitters Interfere...

Страница 12: ...arts with a tool per IEC 60529 Manufacturer Serial Number Catalogue Number Quantity Date of Manufacture Country of Manufacture Storage shipping Temperature Range RoHS Compliant China Medical prescription required Table 1 Labeling Symbols Continued Symbol Description SN REF REF QTY QTY US US ...

Страница 13: ...ows percent blood oxygen saturation SpO2 The range is from 0 to 100 This display also shows the month year and hour 24 hour clock format during startup Pulse Rate Display This 3 digit display located below the SpO2 display shows the pulse rate in beats per minute BPM The range is from 18 to 321 BPM This display also shows the day and minute during startup Activation Switch Sensor Port ...

Страница 14: ...ice is recording data The number bars on the display depends on the pulse strength as determined by the oximeter Full and Partial Display Mode This heart shaped indicator is followed by up to nine curved bars and displays next to the pulse rate Memory Volume MVI Display Mode This indicator consists of up to nine curved bars and displays next to the minutes of stored data For more information see M...

Страница 15: ...k settings are lost Bluetooth Indicator BLE Model only The Bluetooth indicator is used to show the following conditions Flashing once per second The radio is on and is available for a new pairing This will occur for up to 2 minutes following battery installation or until a pairing is made Solid On The Bluetooth radio is on and currently not in a connection Solid on with animated bars The Bluetooth...

Страница 16: ...low Once the shipping carton is unpacked verify these items were received Contact the carrier immediately if the shipping carton is damaged Standard Kit USB or BLE Model 3150 WristOx2 Pulse Oximeter Model 8000SM WO2 reusable soft sensor 1 wristband 2 AAA 1 5 volt alkaline batteries Operator s manual CD USB driver software includes operator s manual required to use the PC USB interface cable Carryi...

Страница 17: ... will terminate and some data from the session may not be saved The terminated session will be time stamped with the current date time the next time the device turns on To avoid potential battery cell damage for all battery types remove batteries from the device when the critical battery indicator displays Leaving rechargeable batteries in the device during critical battery will decrease battery l...

Страница 18: ...le or wrap sensor If the sensor is not used or an inadequate pulse signal is detected for at least 10 minutes the device will turn off To turn the device on again press the activation switch or disconnect and reconnect the sensor Programmed Activation Mode When in Programmed Activation Mode the user can program the device to turn on for up to three sessions In between the programmed sessions the d...

Страница 19: ... Activation Mode Memory Volume MVI Display Mode Memory Volume MVI Display Mode is selected using nVISION software version 6 5 or greater Memory Volume Display Mode is used to quickly see how many hours and minutes of valid data are stored in the device s memory In Memory Volume Display Mode the display screen figure 3 only shows The volume of data in hours and minutes stored in memory hours displa...

Страница 20: ...14 Modes Figure 3 Memory Volume Display Mode The example in figure 3 shows a device with 10 hours and 56 minutes of stored data Pulse Strength Indicator Hours Minutes Battery Indicator ...

Страница 21: ...rt 2 new AAA batteries figure 5 Battery orientation is shown inside the battery compartment Figure 5 Insert Batteries 3 Replace battery door by sliding it back into place WARNING Do not use the device when alarms are required WARNING The USB cable must be unplugged from the device before replacing batteries WARNING Before changing the batteries make sure the device is off and the sensor is not app...

Страница 22: ...and The WristOx2 Model 3150 is designed to be applied to the patient s wrist using a wristband This section contains instructions for attaching the wristband to the device See the Patient Application section for instructions on how to apply the device to the patient Wristband Description There are two wristbands available for the use with the WristOx2 Model 3150 a multiple use wristband and a sing...

Страница 23: ...17 Using the WristOx2 Model 3150 Figure 6 Multiple Use Wristband Figure 7 Thread Short Segment Square Fastener Long Segment Short Segment Plastic Ring Rectangle Fastener ...

Страница 24: ...18 Using the WristOx2 Model 3150 Figure 8 Secure Long Segment ...

Страница 25: ...19 Using the WristOx2 Model 3150 Figure 9 Device with Multiple Use Wristband Attached Front and Back Views Front View Fasteners Sensor Connector Back View ...

Страница 26: ...20 Using the WristOx2 Model 3150 Figure 10 Single Use Wristband ...

Страница 27: ...21 Using the WristOx2 Model 3150 Figure 11 Device with Single Use Wristband Attached ...

Страница 28: ...sing 8000R or 8000QR Noninsensor use sensor adapter cable 3150I see Parts and Accessories 1 Insert the sensor connector into the sensor port at the top of the device figure 12 The Nonin logo on the sensor connector should face the front of the device 2 Push the connector until it clicks into place 3 The device is ready to use Figure 12 Attach Sensor WARNING Only use Nonin branded sensors with a le...

Страница 29: ...he rounded end of the wristband through the plastic ring Pull the strap through the plastic ring until the device fits comfortably on the wrist figure 13 Figure 13 Thread and Tighten Wristband 4 Fold the wristband back over the plastic ring figure 14 and attach the fastener to the wristband figure 15 or figure 16 Wrist circumference will determine which fastener is used 5 If using the single use w...

Страница 30: ...hen using the rectangle fastener the end of the wristband can be shortened To do so fold the end of the wristband so the square fastener attaches onto the wristband figure 15 Figure 14 Fasten Wristband Figure 15 Using the Rectangle Fastener ...

Страница 31: ...25 Using the WristOx2 Model 3150 Figure 16 Using the Square Fastener ...

Страница 32: ...26 Using the WristOx2 Model 3150 Figure 17 Attach Single Use Wristband ...

Страница 33: ...autions and warnings Figure 19 Apply Sensor to Patient 8 When in Spot Check Activation Mode inserting a finger in the sensor automatically turns the device on When the finger is removed the device turns off in approximately 10 seconds NOTE Depending on the sensor and ambient light conditions it may take up to 3 minutes for the device to turn off 9 If the device does not turn on verify battery orie...

Страница 34: ... Activation Mode When the activation switch is pressed Startup Sequence and Self Test If the time is not set the device displays 01 01 10 00 00 January 1st 2010 at 12 00 a m 1 r and the software revision level 2 All display icons If any indicator does not display do not use the device Contact Nonin Technical Service for assistance NOTE The Bluetooth indicator and activity bars will not be shown on...

Страница 35: ... Er and a two digit code table 2 Some error codes may be corrected by the user See Troubleshooting for more information Table 2 Error Codes Error Code Description 01 Configuration sector error 02 Patient data pointer error 03 Main memory pointer error Device memory is intact however the most recent session may be missing from the device 06 Radio Communications Error ...

Страница 36: ...nd pulse strength indicator shows two bars or less Inadequate pulse signal Reposition or replace sensor or place sensor on a different finger Remove and reconnect sensor Hands are cold Warm sensor application site No pulse display on pulse strength bar graph indicator Sensor applied incorrectly Refer to sensor Instructions for Use for proper sensor application Device needs repair Contact Nonin Tec...

Страница 37: ...nin Technical Service Dashes continually display on LCD Sensor malfunction Replace sensor with a Nonin branded sensor Device does not record in Programmed Activation Mode Data collection start and stop times are set incorrectly Use nVISION software to program correct start and stop times Clock settings are lost after replacing batteries Use nVISION software to reset clock Devices will not pair Dev...

Страница 38: ... not machine wash or dry The wristband will shrink if placed in a dryer NOTES Mild detergents such as hand and dish washing liquid detergents dissolve dirt and grease To clean washable surfaces use in a solution of warm water Replace the wristband if the hook and loop fastener no longer secures the wristband to the device or to the patient Storing Store the device within the stated environmental s...

Страница 39: ...nute is not retained in memory Whenever the 3150 is running for more than one minute the 3150 creates a record of the measurements taken and stores them within non volatile memory For each record the current oximeter time and date are stored to allow quick differentiation of recording sessions Within these records patient SpO2 and pulse rate are stored every 4 seconds The frequency of data storage...

Страница 40: ... SpO2 and pulse rate readings do not display on the screen Patient data storage sample rate 1 2 or 4 seconds Activation modes Sensor Activation Spot Check Activation or Programmed Activation see Activation Modes Device ID up to 50 alphanumeric characters Bluetooth Radio disable at startup this setting has no effect on the 3150 USB or 3150 BLE devices Synchronize device time date to the PC time dat...

Страница 41: ...tor s Manual CD 1 Install the USB driver if needed See appropriate USB Driver Installation section for more information 2 Connect the cable to the USB port on the PC 3 Connect the cable to the device s sensor port 4 When the device is ready to use with nVISION these indicators display on the LCD CP Battery indicator 5 For more information about nVISION refer to nVISION Help CAUTION All parts and a...

Страница 42: ...software click Close 11 In the Device Manager window look up the communications comm or COM port for the device Expand Ports COM LPT One port should say Nonin Model 3150 COM Make a note of the COM It is needed to set up the Model 3150 with nVISION software USB Driver Installation Windows 8 1 The USB driver software is on the Model 3150 Operator s Manual CD Insert the CD into the PC s CD DVD drive ...

Страница 43: ...9 In the Device Manager window look up the communications comm or COM port for the device Expand Ports COM LPT One port should say Nonin Model 3150 COM Make a note of the COM It is needed to set up the Model 3150 with nVISION software Bluetooth Connection Before a Bluetooth collector device can connect and obtain data from the 3150 BLE the devices must be paired The 3150 BLE will be in pairing mod...

Страница 44: ...transmit data again one second later If the connection is lost the device will change the Bluetooth symbol from green to white and become available for a connection in a few seconds Bluetooth Profiles Supported GATT based proprietary Nonin profile Authentication and Encryption Supported Encryption Key Size 128 bits AES advanced encryption standard The Bluetooth word mark and logo are registered tr...

Страница 45: ...e to other equipment follow each device s cleaning instructions Verify all equipment connected to the device is suitable for the patient s environment CAUTION Failure of a network data coupling serial cable connectors wireless connections will result in loss of data transfer ...

Страница 46: ...t Windows operating systems 3150I Sensor Interface Cable Used to connect 1 meter 9 pin connector sensors to the WristOx2 Model 3150 Compatible with Model 8000R and 8000Q2 1 meter sensors see below contact Nonin or your distributor or visit www nonin com 3150WB Wristband WARNING Only use Nonin branded sensors with a length of 1 meter or less Accuracy may degrade if sensor cable is over 1 meter in l...

Страница 47: ...and Accessories Model Number Description 6000CA WO2 Cloth Disposable Sensor Optional Pulse Oximeter Sensors use with Interface Cable 3150I Reusable 1 meter length 8000Q2 Ear Clip Sensor 8000R Reflectance Sensor ...

Страница 48: ... product to Nonin To obtain this return authorization number contact Nonin s Technical Service Department at Nonin Medical Inc 13700 1st Avenue North Plymouth Minnesota 55441 USA 800 356 8874 USA and Canada 1 763 553 9968 Fax 1 763 553 7807 E mail technicalservice nonin com Nonin Medical B V Prins Hendriklaan 26 1075 BD Amsterdam Netherlands 31 0 13 79 99 040 Europe Fax 31 0 13 79 99 042 E mail te...

Страница 49: ...ON A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor CAUTION All parts and accessories connected to the USB port of this device must be certified according to at least IEC Standard EN 60950 IEC 62368 1 or UL 1950 for data processing equipment WARNING Portable RF communications equipment such as cell phones or radios including peripherals such as antenn...

Страница 50: ... 4 3 80 MHz 2 7 GHz 10 V m 380 390 MHz 27 V m 430 470 MHz 28 V m 704 787 MHz 9 V m 800 960 MHz 28 V m 1 7 1 99 GHz 28 V m 2 4 2 57 GHz 28 V m 5 1 5 8 GHz 9 V m Table 5 Not Applicable Harmonic Emissions IEC 61000 3 2 Voltage Flicker Emissions IEC 61000 3 3 Electrical Fast Transients IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips IEC 61000 4 11 Conducted Immunity IEC 61000 4 6 NOTE These guidelines ...

Страница 51: ...10 seconds Pulse Rate 75 BPM Specific to this example The response of the 4 beat average is 1 5 seconds SpO2 Values Average Latency Standard Fast Averaged SpO2 4 beat exponential 2 beats Pulse Rate Values Response Latency Standard Fast Averaged Pulse Rate 4 beat exponential 2 beats Equipment Delays Delay Display Update Delay 1 5 seconds 60 65 70 75 80 85 90 95 100 0 0 8 0 16 0 24 0 32 0 40 0 48 0 ...

Страница 52: ...eter equipment for medical use Pulse Rate Motion Testing This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter tester This test determines whether the oximeter meets the criteria of ISO 80601 2 61 for pulse rate during simulated movement tremor and spike motions Low Perfusion Testing This test uses an SpO2 Simulator to provide a simulated pu...

Страница 53: ...lly useful for clinicians performing photodynamic therapy Red 660 nanometers 0 8 mW max avg Infrared 910 nanometers 1 2 mW max avg Temperature Operating 5 C to 40 C 23 F to 104 F Storage Transportation 40 C to 70 C 40 F to 158 F Time from storage for monitor to be ready for its intended use 10 minutes to warm from 40 C to 5 C 10 minutes to cool from 70 C to 40 C Device temperature will not exceed ...

Страница 54: ... wristband 51 mm x 73 mm x 19 mm H x W x D 2 0 in x 2 9 in x 0 75 in Weight with batteries and wristband 70 0 g 2 5 oz Memory Type Non volatile Capacity up to 1 080 hours 4 sec data storage rate up to 540 hours 2 sec data storage rate up to 270 hours 1 sec data storage rate Classification per ANSI AAMI ES60601 1 and CAN CSA C22 2 No 60601 1 Type of Protection Internally powered battery power Degre...

Страница 55: ...erating Frequency 2 4 to 2 4835 GHz Output Power 3 dBm Operating Range 60 meter 196 foot radius indoors Network Topology Point to Point Operation Peripheral Slave Antenna Type Internal Modulation Type Frequency Shift Keying Frequency Hopping Spread Spectrum Band Width 1 MHz ...

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