Nonin WristOx2 3150 Operator's Manual
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Nonin WristOx2 3150 Operator's Manual

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Operator's Manual
Model 3150
WristOx
Pulse Oximeter
®
2
BLE and USB
English
0123

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Summary of Contents for Nonin WristOx2 3150

  • Page 1 Operator’s Manual Model 3150 WristOx Pulse Oximeter ® BLE and USB English 0123...
  • Page 2 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 those of their respective owners.

  • Page 3: Table Of Contents

    Contents Indications for Use ....................1 Warnings ........................ 1 Cautions ......................... 2 Declaration of Conformity with FCC and Canadian Ministry of Health Rules for Electromagnetic Compatibility ................ 3 Point-to-Point Communications (BLE Only)............4 Guide to Symbols...................... 5 Displays, Controls, and Indicators ................7 Introduction ......................
  • Page 4 Contents (continued) Memory and Data .....................33 nVISION Software ....................34 nVISION Settings ....................34 Accessing nVISION Settings ................34 Cable Connection....................35 USB Driver Installation (Windows 7)..............36 USB Driver Installation (Windows 8)..............36 USB Driver Installation (Windows 10)..............37 Bluetooth Connection....................37 Bluetooth Security....................37 Bluetooth Wireless Technology Information ............38 Connecting the Device into a Medical System............38 Parts and Accessories ....................40 Sensors .........................40...
  • Page 5 Figures Figure 1. Front Display (Startup Screen)..............7 Figure 2. Comparison of Full and Partial Display ............. 13 Figure 3. Memory Volume Display Mode ..............14 Figure 4. Remove Battery Door................15 Figure 5. Insert Batteries ..................15 Figure 6. Multiple Use Wristband ................17 Figure 7.
  • Page 6 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...

  • Page 7: Indications For Use

    To avoid patient injury, use only Nonin-branded PureLight pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for Nonin 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.

  • Page 8: Cautions

    Indications for Use Warnings (Continued) Only use Nonin-branded sensors with a length of 1 meter or less. Accuracy may degrade if sensor cable is over 1 meter in length. Using the sensor cable adapter does not affect accuracy. Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables specified by the manufacturer.

  • Page 9: Declaration Of Conformity With Fcc And Canadian Ministry Of Health Rules For Electromagnetic Compatibility

    Declaration of Conformity with FCC and Canadian Ministry of Health Rules for Electromagnetic Compatibility • Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares under its sole responsibility that Model 3150, WristOx Pulse Oximeter, to which this declaration relates, complies with part 15 of the FCC Rules.

  • Page 10: Point-To-Point Communications (Ble Only)

    ANSI/IEEE Std. C95.1-2005. • The FCC requires the user to be notified that any changes or modifications to this device that are not expressly approved by Nonin Medical, Inc. may void the user’s authority to operate the device.

  • Page 11: Guide To Symbols

    Guide to Symbols Guide to Symbols This chapter describes the symbols that are found in this manual and on the WristOx Model 3150. Detailed information about display symbols can be found in “Displays, Controls, and Indicators.” Table 1: Labeling Symbols Symbol Description Caution!
  • Page 12 Guide to Symbols Table 1: Labeling Symbols (Continued) Symbol Description Protected against spraying water and against access to hazardous parts with a IP33 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...

  • Page 13: Displays, Controls, And Indicators

    Displays, Controls, and Indicators Displays, Controls, and Indicators Sensor Port Activation Switch Figure 1: Front Display (Startup Screen) %SpO Display This 3-digit display, located in the upper left corner of the LCD, shows percent blood oxygen saturation (%SpO ). The range is from 0 to 100 %.
  • Page 14 Displays, Controls, and Indicators Activation Switch The activation switch is located next to the sensor port at the top of the WristOx , Model 3150. Pressing the switch will turn on the device. Sensor Fault Indicator This indicator displays if the device determines a sensor fault exists (e.g., sensor disconnect, misalignment, or incompatibility with the device).
  • Page 15 Displays, Controls, and Indicators Battery Indicator Full This indicator shows remaining battery life as either full, half, low, and critical (as shown at left). Half Replace the batteries when device reaches low state. Critical When the battery reaches critical state: •...

  • Page 16: Introduction

    The 3150 BLE model includes a Bluetooth Low Energy radio with a range (spherical radius) of approximately 60 meters (196 feet). ® Advanced memory and programming features are available with Nonin’s nVISION software (version 6.5 or greater). See the “nVISION Software” section to learn more about using the device with nVISION.

  • Page 17: Bluetooth Technology (3150 Ble Only)

    Nonin’s use of Bluetooth wireless technology allows SpO and pulse rate data to be transmitted through a Bluetooth radio to a compatible Bluetooth-enabled device. Nonin’s wireless system removes the cable connection from the device, giving patients increased ability to move freely.

  • Page 18: Modes

    Modes Modes The WristOx Model 3150, has two types of mode settings: Activation and Display, which are described below. Activation Modes Activation modes determine how the 3150 turns off and on. Spot Check Activation Mode is the factory default. Spot Check Activation Mode In this activation mode, the 3150 will automatically turn on when a finger is inserted into the sensor.

  • Page 19: Display Modes

    Modes Display Modes Full Display Mode is the factory default. Full Display Mode Full Display Mode will display SpO , pulse rate, the animated pulse strength indicator and battery life on the display (as well as the connection status for the 3150 BLE.) Partial Display Mode When using Partial Display Mode, the SpO and the pulse rate readings do not display.

  • Page 20: Figure 3. Memory Volume Display Mode

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

  • Page 21: Using The Wristox Model 3150

    Using the WristOx Model 3150 Using the WristOx Model 3150 WARNING: Do not use the device when alarms are required. WARNING: The USB cable must be unplugged from the device before replacing batteries. Installing Batteries WARNING: Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.

  • Page 22: Attaching The Wristband

    Using the WristOx Model 3150 4. Inserting batteries does not turn the device on. In Spot Check Activation Mode, the device turns on when a finger is inserted in the sensor. NOTE: When batteries are removed in low battery mode, the device maintains the time and date for up to 30 seconds.

  • Page 23: Figure 6. Multiple Use Wristband

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

  • Page 24: Figure 8. Secure Long Segment

    Using the WristOx Model 3150 Figure 8: Secure Long Segment...

  • Page 25: Figure 9. Device With Multiple Use Wristband Attached (Front And Back Views)

    Using the WristOx Model 3150 Sensor Connector Fasteners Front View Back View Figure 9: Device with Multiple Use Wristband Attached (Front and Back Views)

  • Page 26: Figure 10. Single Use Wristband

    Using the WristOx Model 3150 Figure 10: Single Use Wristband...

  • Page 27: Figure 11. Device With Single Use Wristband Attached

    Using the WristOx Model 3150 Figure 11: Device with Single Use Wristband Attached...

  • Page 28: Attaching The Sensor

    If using 8000R or 8000QR Noninsensor, use sensor adapter cable 3150I (see “Parts and Accessories”). 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 length. Using the sensor cable adapter does not affect accuracy.

  • Page 29: Patient Application

    Using the WristOx Model 3150 Patient Application The WristOx Model 3150, is usually worn on the back of a patient’s wrist. NOTE: The wristband can be used to secure the device to an alternate location (e.g., the upper arm or a bed rail). NOTE: Ensure the wristband fits comfortably on the patient’s arm.

  • Page 30: Figure 14. Fasten Wristband

    Using the WristOx Model 3150 NOTE: When 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...

  • Page 31: Figure 16. Using The Square Fastener

    Using the WristOx Model 3150 Figure 16: Using the Square Fastener...

  • Page 32: Figure 17. Attach Single Use Wristband

    Using the WristOx Model 3150 Figure 17: Attach Single Use Wristband...

  • Page 33: Figure 18. Removal Of Single Use Wristband

    Using the WristOx Model 3150 Figure 18: Removal of Single Use Wristband 6. Attach the sensor if it is not already connected (see “Attaching the Sensor”). 7. Apply the sensor to the patient (figure 19). Refer to the sensor Instructions for Use for proper sensor application sites and sensor application cautions and warnings.

  • Page 34: Verifying Operation

    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 the 3150 USB.

  • Page 35: Error Codes

    Using the WristOx Model 3150 Error Codes This device includes error codes that indicate problems with the unit. When an error occurs, the device displays the letters “Er” and a two-digit code (table 2). Table 2: Error Codes Error Code Description Configuration sector error Patient data pointer error...

  • Page 36: Troubleshooting

    Warm sensor application site. Refer to sensor Instructions for Use Sensor applied incorrectly. for proper sensor application. Device needs repair. Contact Nonin Technical Service. Possible interference from blood flow restrictors (arterial Reduce or eliminate restriction. catheters, blood pressure cuffs, infusion lines, etc.).
  • Page 37 Full Display Mode. Mode. not display. If these solutions do not correct the problem, please contact Nonin Technical Service at (800) 356-8874 (USA and Canada), + 1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).

  • Page 38: Care And Maintenance

    Care and Maintenance Care and Maintenance The device requires no calibration or maintenance other than battery replacement. Cleaning the Device Wipe the device with a soft cloth dampened with a 10% bleach/90% water solution (household bleach [containing less than 10% sodium hypochlorite]). Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result.

  • Page 39: Memory And Data

    Memory and Data Memory and Data The WristOx Model 3150 measures, collects, and stores up to 1,080 hours of SpO and pulse rate data with a 4-second data collection rate. Data collected at a 1 or 2-second rate reduces memory capacity to 270 or 540 hours, respectively. When the memory is full, the device overwrites the oldest existing data with the new data.

  • Page 40: Nvision Software

    Software nVISION Software Nonin’s nVISION software works with Microsoft Windows ® operating systems. It allows users to transfer recorded patient data from the device to a PC and then analyze, report, and archive the data. The software is required to access the device’s additional modes of operation and advanced features.

  • Page 41: Cable Connection

    nVISION Software 8. For more information, see nVISION Help. Figure 20: nVISION Settings Window NOTE: Bluetooth Radio - disable at startup does not have an effect on the 3150 BLE or 3150 USB. Cable Connection 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.

  • Page 42: Usb Driver Installation (Windows 7)

    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.

  • Page 43: Usb Driver Installation (Windows 10)

    10. 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.

  • Page 44: Bluetooth Wireless Technology Information

    If data is lost, the device will 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. GATT-based proprietary Nonin profile Bluetooth Profiles Supported: Supported Authentication and Encryption:...
  • Page 45 nVISION Software NOTES: • When using the sensor port to connect the device 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.

  • Page 46: Parts And Accessories

    For more information about Nonin parts, accessories, and sensors, contact your distributor, or contact Nonin at (800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe). This information is also available on Nonin’s website: www.nonin.com.
  • Page 47 Parts 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...

  • Page 48: Service, Support, And Warranty

    For information about the device and accessories, contact your local sales representative or distributor. For the sales representative or distributor in your area, contact Nonin. A return authorization number is required before returning any product to Nonin. To obtain this return authorization number, contact Nonin’s Technical Service Department at: Nonin Medical, Inc.

  • Page 49: Technical Information

    Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the Indications For Use. If issues are experienced, move the Nonin system away from the source of electromagnetic disturbances.

  • Page 50: Table 4. Electromagnetic Immunity

    Technical Information Table 4: Electromagnetic Immunity Immunity Test Compliance Electrostatic Discharge (ESD) ±8 kV contact IEC 61000-4-2 ±15 kV air 150 kHz 3 Vrms ISM and Amateur radio Conducted RF IEC 61000-4-6 bands between 150 6 Vrms kHz to 80 MHz Power Frequency (50/60 Hz) Magnetic Field 30 A/m IEC 61000-4-8...

  • Page 51: Equipment Response Time

    Technical Information Equipment Response Time If the signal from the sensor is inadequate, the last measured SpO and pulse rate values freeze for 10 seconds and are then replaced with dashes. Values Average Latency Standard/Fast Averaged SpO 4 beat exponential 2 beats Pulse Rate Values Response...

  • Page 52: Testing Summary

    Technical Information Testing Summary accuracy and low perfusion testing was conducted by Nonin Medical, Inc., as described below. Accuracy Testing During motion and no-motion conditions at an independent research laboratory, SpO accuracy testing is conducted during induced hypoxia studies on healthy, male and female, non-smoking, light- to dark-skinned subjects that are 18 years of age and older.

  • Page 53: Specifications

    Pulse Strength: Pulse Strength Bar Graph Accuracy – Sensors: Declared accuracy data for compatible sensors can be found in Nonin’s Sensor Accuracy document. Measurement Wavelengths and Output Power Red: 660 nanometers @ 0.8 mW max. avg. Infrared: 910 nanometers @ 1.2 mW max. avg.
  • Page 54 Technical Information Power Requirements: Two AAA (1.5V) batteries Battery Life (expected minimum): Rechargeable Rechargeable Alkaline NOTE: Based on testing new and fully-charged batteries. See footnotes for brands used. Refer to battery manufacturers’ (700 mAh) (1050 mAh) operator’s manuals for instructions for use. Storage: MVI Display Mode off: 9 months Not specified...

  • Page 55: Transmitter

    Technical Information Transmitter Bluetooth Compliance Version 4.2 Operating 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 Frequency Shift Keying Modulation Type Frequency Hopping Spread Spectrum Band Width 1 MHz...

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