Operator’s Manual Model 3150 WristOx2® Pulse Oximeter Wrist-Worn Pulse Oximeter with Bluetooth® Wireless Technology 0123 English
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Consult Instructions for Use. Nonin® reserves the right to make changes and improvements to this manual and the products it describes at any time, without notice or obligation. Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441-5443, USA + 1 (763) 553-9968 800-356-8874 (USA and Canada) Fax: + 1 (763) 553-7807 E-mail: info@nonin.com Nonin Medical B.V.
Contents Indications for Use .................................................................................................... 1 Contraindications.................................................................................................... 1 Warnings ................................................................................................................ 1 Cautions .................................................................................................................
Contents (continued) Cleaning the Wristband.........................................................................................27 Storing...................................................................................................................27 Memory and Data .....................................................................................................28 nVISION Software ....................................................................................................
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 .........................................
Tables Table 1. Table 2. Table 3. Table 4. Table 5. Table 6. iv Labeling Symbols......................................................................................... 6 Error Codes................................................................................................ 24 Electromagnetic Emissions........................................................................ 38 Electromagnetic Immunity..........................................................................
Indications for Use Indications for Use The Nonin WristOx2®, Model 3150 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking and/or data collection and recording of adult and pediatric patients, during both no motion and motion conditions, and for patients who are well or poorly perfused.
Indications for Use Warnings (Continued) This equipment complies with International IEC 60601-1-2:2007 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation.
Indications for Use Cautions (Continued) Verify all visible indicators appear during the start-up (initialization) sequence. If any indicator does not appear, do not use the device. Contact Nonin Technical Service for assistance. Portable and mobile RF communications equipment can affect medical electrical equipment. Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for more than 30 days. Do not use different types of batteries at the same time.
Indications for Use 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 the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device generates, uses, and can radiate radio frequency energy.
Indications for Use Point-to-Point Communications The WristOx2, Model 3150, features point-to-point communications, allowing one master device (the display device) to be paired to one slave device (the patient module). Once connected, neither device is detectable by any other Bluetooth-enabled device, which reduces the risk of interference and preserves data integrity.
Guide to Symbols Guide to Symbols This chapter describes the symbols that are found in this manual and on the WristOx2, Model 3150. Detailed information about display symbols can be found in “Displays, Controls, and Indicators.” Table 1: Labeling Symbols Symbol Description Caution! ! Consult Instructions for Use. Follow Instructions for Use. EC REP 0123 Authorized Representative in the European Community. CE Marking indicating conformance to EC directive No. 93/42/EEC concerning medical devices.
Displays, Controls, and Indicators Displays, Controls, and Indicators Activation Switch Sensor Port Figure 1: Front Display (Startup Screen) %SpO2 Display This 3-digit display, located in the upper left corner of the LCD, shows 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.
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. See “Activation Switch” section for more information. Sensor Fault Indicator This indicator displays if the device determines a sensor fault exists (e.g., sensor disconnect, misalignment, or incompatibility with the device).
Displays, Controls, and Indicators Full Battery Indicator Half This indicator shows remaining battery life as either full, half, low, and critical (as shown at left). Low Replace the batteries when device reaches low state. Critical When the battery reaches critical state: • All indicators clear from the display except for the blinking critical battery indicator. • The current session closes. • The Bluetooth radio shuts down. • The clock settings are lost. • The device reverts to Spot Check mode.
Introduction Introduction The Bluetooth-enabled WristOx2, Model 3150, is a small, wrist-worn device that displays, measures, and stores patient SpO2 and pulse rate data. The device includes a Bluetooth radio with a range (spherical radius) of approximately 100 meters (328 feet). The device ships ready to use in Spot Check turn on mode. In Spot Check turn on mode, inserting a finger in the sensor automatically turns the device on.
Introduction Batteries The device uses 2 AAA alkaline batteries. With new alkaline batteries, battery life is approximately 48 hours (minimum) when not connected to a Bluetooth device. When connected to a Bluetooth device, battery life will vary depending on class of operation. See “Specifications” for detailed battery life information. The battery indicator shows one of four states: full, half, low, and critical. Replace the batteries when device reaches low state.
Operation Modes Operation Modes The WristOx2, 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.
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). NOTE: The sensor does not need to be applied to a finger to turn the device on.
Operation Modes Memory Volume (MVI) Display Mode NOTE: When the device is in Memory Volume display mode, the %SpO2 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). MVI display mode functions with all operating modes (spot check, sensor activation, and programmed).
Using the WristOx2, Model 3150 Using the WristOx2, 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. 1. Open the battery compartment by sliding the battery door off the back of the device (figure 4). Figure 4: Remove Battery Door 2.
Using the WristOx2, 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. After battery replacement, check the device’s screen during startup to ensure date and time are set. If the battery level is at or below the critical level, clock settings are lost and the device reverts to Spot Check mode.
Using the WristOx2, Model 3150 Figure 7: Thread Short Segment Figure 8: Secure Long Segment 17
Using the WristOx2, Model 3150 Fasteners Sensor Connector Front View Back View Figure 9: Device with Wristband Attached (Front and Back Views) 18
Using the WristOx2, Model 3150 Attaching the Sensor The sensor can be connected to the device before or after applying the device to the patient. The following steps apply to these Nonin sensors: • 8000SS-WO2, 8000SM-WO2, 8000SL-WO2 • 8000AA-WO2 • 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.
Using the WristOx2, Model 3150 Patient Application The WristOx2, 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. Do not over-tighten the wrist band. 1. Verify the wristband has been attached properly to the device (figure 9). If the wristband has not been attached to the device, see “Attaching the Wristband.” 2.
Using the WristOx2, Model 3150 Figure 12: Fasten Wristband Figure 13: Using the Rectangle Fastener 21
Using the WristOx2, 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. Figure 15: Apply Sensor to Patient 7. When in Spot Check mode, inserting a finger in the sensor automatically turns the device on.
Using the WristOx2, Model 3150 Verifying Operation When the WristOx2, Model 3150, first turns on, it performs a startup sequence and self-test. It occurs: • When a sensor is applied to a patient (Spot Check mode). • When a sensor is attached to the device (Sensor Activation mode). • At a programmed start time when a sensor is attached to the device (Programmed mode). • After the activation switch is pressed while the device is in Standby mode.
Using the WristOx2, Model 3150 Activation Switch The activation switch is located next to the sensor port at the top of the WristOx2, Model 3150. It is primarily used to: • Activate the Bluetooth radio when the device is either on or in Standby. • Activate the device when it is in Sensor Activation mode so the user does not need to disconnect and reconnect the sensor. It will also activate the device when it is in Spot Check and Programmed modes.
Troubleshooting Troubleshooting Problem Device will not activate. Possible Cause Possible Solution Batteries inserted wrong. Check batteries. Batteries are depleted. Replace batteries. Sensor is disconnected. Reconnect sensor. Device is in Sensor Activation mode and has timed out. Press the activation switch. Disconnect and then reconnect the sensor. Device is in Programmed mode. Use nVISION software to select Spot Check or Sensor Activation mode. %SpO2 and pulse rate do not display.
Troubleshooting Problem Er 01 displays on LCD. Possible Cause Possible Solution Device configuration memory failure. Device reverts to default settings (Spot-Check mode, 4-second sample rate). Use nVISION software to change settings. If error code continues, contact Nonin Technical Service. Er 02 or 04 displays Device memory failure. on LCD. Contact Nonin Technical Service. Er 03 or 05 displays on LCD. Device failure.
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]). Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result. Dry with a soft cloth, or allow to air dry.
Memory and Data Memory and Data The WristOx2, Model 3150 measures, collects, and stores up to 1,080 hours of SpO2 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. Each time the device is turned on, data are automatically stored in memory. Data collection of less than 1 minute is not retained in memory.
nVISION 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.
nVISION Software 7. Click OK. 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. Once connected to a PC, the device settings may be accessed and data can be downloaded using nVISION software.
nVISION Software 5. For more information about nVISION, refer to nVISION Help. NOTE: Disconnect the USB interface cable from the device when the data transfer or device configuration is complete. Leaving the cable connected will reduce battery life. USB Driver Installation (XP SP3) 1. The USB driver software is on the Model 3150 Operator’s Manual CD. Insert the CD into the PC’s CD/DVD drive. 2. Connect the Model 3150SC USB cable to the sensor port on the Model 3150 and a USB port on the PC. 3.
nVISION Software USB Driver Installation (Vista) 1. Connect the Model 3150SC USB cable to the sensor port on the Model 3150 and a USB port on the PC. 2. In the Found New Hardware window, select Locate and install driver software (recommended). 3. Windows needs your permission to continue pop up appears. Continue with installation. 4. The USB driver software is on the Model 3150 Operator’s Manual CD. Insert the CD into the PC’s CD/DVD drive and click Next. 5.
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. 2. Connect the Model 3150SC USB cable to the sensor port on the Model 3150 and a USB port on the PC. 3. Open the Device Manager by right clicking in the bottom left corner of the screen and then click Device Manager. Device Manager window opens. 4. If needed, expand Other devices. 5. Right click Model 3150 and select Update Driver Software...
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. While the 3150 is in a Bluetooth connection, it will be unavailable for other connections.
Parts and Accessories 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. Model Number Description 3100CC Carrying Case 3150 Manual CD with Operator’s Manual and USB Driver Software 3150SC PC USB Interface Cable nVISION nVISION Software (version 6.3 or greater).
Parts and Accessories Model Number Description Optional Pulse Oximeter Sensors (use with Adapter 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 Soft Sensor (medium) 8000SL Soft Sensor (large) 8000J / 8000JFW Adult Flex Reusable Sensor / FlexiWrap® Single-Use Sensor Wrap Disposable – 1 meter length 6000 S
Service, Support, and Warranty Service, Support, and Warranty Service and Support 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.
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. Manufacturer’s Declaration Refer to the following table for specific information regarding this device’s compliance to IEC 60601-1-2.
Technical Information Table 4: Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic 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 (ESD) ±6 kV contact ±8 kV air IEC 61000-4-2 ±6 kV contact Floors should be wood, concrete, or ceramic tile.
Technical Information Table 5: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic 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.
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.
Technical Information Equipment Response Time If the signal from the sensor is inadequate, the last measured SpO2 and pulse rate values freeze for 10 seconds and are then replaced with dashes. 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 Example - SpO2 Exponential Averaging SpO2 decreases 0.
Technical Information Testing Summary SpO2 accuracy and low perfusion testing was conducted by Nonin Medical, Inc., as described below. SpO2 Accuracy Testing During motion and no-motion conditions at an independent research laboratory, SpO2 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.
Technical Information Specifications Oximeter Specifications Oxygen Saturation Display Range: 0 to 100 % SpO2 Pulse Rate Display Range: 18 to 321 beats per minute (BPM) Displays: Numeric: 3-digit LCD 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 Powera: Red: 660 nanometers @ 0.8 mW max. avg. Infrared: 910 nanometers @ 1.2 mW max. avg. a.
Technical Information System Specifications Temperature: Operating: -5 °C to 40 °C (23 °F to 104 °F) Storage/Transportation: -40 °C to 70 °C (-40 °F to 158 °F) Device temperature will not exceed 41°C as measured during a controlled environment test. Humidity: Operating: 10 % to 95 % noncondensing Storage/Transportation: 10 % to 95 % noncondensing Operating Altitude: Up to 12,192 meters (40,000 feet) Operating Hyperbaric Pressure: Up to 4 atmospheres Power Requirements: Two AAA (1.
Technical Information Transmitter Bluetooth Compliance: Version 2.0 Operating Frequency: 2.4 to 2.
