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

Wrist-worn pulse oximeter with bluetooth wireless technology
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See also: Operator's Manual
Operator's Manual
Model 3150
WristOx
Pulse Oximeter
®
2
Wrist-Worn Pulse Oximeter
®
with Bluetooth
Wireless
Technology
0123
English

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Summary of Contents for Nonin WristOx2 3150

  • Page 1 Operator’s Manual Model 3150 WristOx Pulse Oximeter ® Wrist-Worn Pulse Oximeter ® with Bluetooth Wireless Technology 0123 English...
  • 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 NCC........................3 Federal Communications Commission (FCC) Notice ..........3 Point-to-Point Communications ................4 Guide to Symbols......................
  • Page 4 Contents (continued) Storing........................27 Memory and Data .....................28 nVISION Software ....................29 nVISION Settings ....................29 Accessing nVISION Settings ................29 Cable Connection....................30 USB Driver Installation (Windows 7)..............31 USB Driver Installation (Windows 8)..............31 USB Driver Installation (Windows 10)..............32 Bluetooth Connection....................32 Bluetooth Security....................33 Connecting the Device into a Medical System ............33 Parts and Accessories ....................34 Sensors .........................34 Service, Support, and Warranty ................36...
  • 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. Wristband ....................16 Figure 7.
  • Page 6 Tables Table 1. Labeling Symbols..................5 Table 2. Error Codes....................24 Table 3. Electromagnetic Emissions................ 37 Table 4. Electromagnetic Immunity................38 Table 5. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity..39 Table 6. Recommended Separation Distances ............40...

  • Page 7: Indications For Use

    EMC information specified in this manual. 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 8: Cautions

    Do not perform any testing or maintenance on this device while it is being used to monitor a patient. This device is a precision electronic instrument and must be repaired by Nonin Technical Service. Field repair of this device is not possible. Except to replace batteries, do not attempt to open the case or repair the electronics.

  • 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

    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 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 This switch is located next to the sensor port. Pressing this switch activates the Bluetooth radio for 3 minutes. It can also be used to turn the device on when it is in Standby mode.
  • 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

    Approximately 10 seconds after the finger is removed, the device enters Standby mode. ® Advanced memory and programming features are available with Nonin’s nVISION software (version 6.3 or greater). See the “nVISION Software” section to learn more about using the device with nVISION.

  • Page 17: Bluetooth Technology

    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: Operation Modes

    Operation Modes Operation Modes The WristOx Model 3150, has three states: Cable, Standby, and On. Cable The device is in Cable mode when it is connected to a PC using the USB interface cable. While in Cable mode, the device does not collect or save data and the Bluetooth radio is off. NOTE: To save battery life, the Model 3150 will automatically shut off after 60 minutes when it is connected to a PC using the USB interface cable.

  • Page 19: Sensor Activation Mode

    Operation Modes Sensor Activation Mode Sensor Activation mode may be selected through nVISION software. In this mode, the device turns on when the activation switch is pressed or when the sensor is disconnected and reconnected. This mode is useful when using a sensor that is not easily removed from the sensor site (e.g., disposable or wrap sensor).

  • Page 20: Memory Volume (Mvi) Display Mode

    Operation Modes Memory Volume (MVI) Display Mode NOTE: When the device is in Memory Volume display mode, the %SpO and pulse rate readings do not display on the screen. MVI display mode is selected using nVISION software (version 6.4 or greater) or it can be enabled using an OEM command (refer to the Model 3150 OEM Specification and Technical Information for details).

  • 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 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 7. Thread Short Segment

    Using the WristOx Model 3150 Figure 7: Thread Short Segment Figure 8: Secure Long Segment...

  • Page 24: Figure 9. Device With Wristband Attached (Front And Back Views)

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

  • Page 25: Attaching The Sensor

    • 8000J-WO2 NOTE: Refer to the sensor Instructions for Use for appropriate sensor sizing. If using another Nonin-branded sensor, use sensor adapter cable 3150I (see “Parts and Accessories”). WARNING: Only use Nonin-branded sensors with a length of 1 meter or less.

  • Page 26: 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 27: Figure 12. Fasten Wristband

    Using the WristOx Model 3150 Figure 12: Fasten Wristband Figure 13: Using the Rectangle Fastener...

  • Page 28: Figure 14. Using The Square Fastener

    Using the WristOx Model 3150 Figure 14: Using the Square Fastener 5. Attach the sensor if it is not already connected (see “Attaching the Sensor”). 6. Apply the sensor to the patient (figure 15). Refer to the sensor Instructions for Use for proper sensor application sites and sensor application cautions and warnings.

  • Page 29: Verifying Operation

    (example shows 23 April 2010 at 5:57 p.m.): Month and Day Year Hour and Minutes (MM:DD) (YY) (HH:MM) If the time is not set, the device displays 01:01:10:00:00. If any indicator does not display, do not use the device. Contact Nonin Technical Service for assistance.

  • Page 30: Activation Switch

    Using the WristOx Model 3150 Activation Switch The activation switch is located next to the sensor port at the top of the WristOx Model 3150. It is primarily used to: • Activate the Bluetooth radio when the device is either on or in Standby. •...

  • Page 31: 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 32 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 33: Care And Maintenance

    Care and Maintenance Care and Maintenance The device requires no calibration or maintenance other than battery replacement. The device’s expected service life is 5 years. 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]).

  • Page 34: 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 35: Nvision Software

    Software nVISION Software ® Nonin’s nVISION software (version 6.3 or greater) 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 36: Cable Connection

    nVISION Software 8. For more information, see nVISION Help. Figure 16: nVISION Settings Window Cable Connection NOTE: To save battery life, the Model 3150 will automatically shut off after 60 minutes when it is connected to a PC using the USB interface cable. To connect the device to a PC, use the PC USB interface cable found in the starter kit.

  • Page 37: 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 38: Usb Driver Installation (Windows 10)

    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.

  • Page 39: Bluetooth Security

    nVISION Software Bluetooth Security The Bluetooth radio contained in the 3150 is compliant to version 2.0 of the Bluetooth Specification. It supports the Serial Port Protocol (SPP) and the Health Device Profile (HDP) with security mode 2 (service level enforced). The supported encryption key size is up to 128 bits and encryption is enforced on all outgoing and incoming data channels.

  • Page 40: 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 41 Parts and Accessories Model Number Description Optional Pulse Oximeter Sensors (use with Interface Cable 3150I) Reusable – 1 meter length 8000AA Adult Articulated Finger Clip Sensor 8000AP Pediatric Finger Clip Sensor 8000Q2 Ear Clip Sensor 8000R Reflectance Sensor 8000H Reflectance Sensor Holder 8000SS Soft Sensor (small) 8000SM...

  • Page 42: Service, Support, And Warranty

    Pulse Oximeter for 3 years from the date of purchase. Nonin shall repair or replace any WristOx Model 3150, found to be defective in accordance with this warranty, free of charge, for which Nonin has been notified by the purchaser by serial number that there is a defect, provided said notification occurs within the applicable warranty period.

  • Page 43: Technical Information

    Technical Information Technical Information NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. CAUTION: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment.

  • Page 44: Table 4. Electromagnetic Immunity

    Technical Information Table 4: Electromagnetic Immunity Compliance Electromagnetic Immunity Test IEC 60601 Test Level Level Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Electrostatic Discharge ±8 kV contact ±8 kV contact...

  • Page 45: Table 5. Guidance And Manufacturer's Declaration-Electromagnetic Immunity

    Technical Information Table 5: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IEC 60601 Test Compliance Immunity Test Electromagnetic Environment—Guidance Level Level This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used 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.

  • Page 46: Table 6. Recommended Separation Distances

    Technical Information Table 6: Recommended Separation Distances This table details the recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 47: 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 48: 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 49: 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 50 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) (1100 mAh) operator’s manuals for instructions for use. Storage: MVI display mode off: 9 months Not specified...

  • Page 51: Transmitter

    Technical Information Transmitter Bluetooth Compliance: Version 2.0 Operating Frequency: 2.4 to 2.4835 GHz Output Power: < 20 dBm Operating Range: 100-meter (328-foot) radius indoors Network Topology: Point-to-Point Operation: Slave Antenna Type: Internal Modulation Type: Frequency Shift Keying Frequency Hopping Spread Spectrum Band Width: 1 MHz...

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