WristOx2 Model 3150 BLE and USB Operators Manual

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Follow Instructions for Use. 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, USA Phone: + 1 (763) 553-9968 800-356-8874 (USA and Canada) E-mail: [email protected] Nonin Medical B.V. Prins Hendriklaan 26 1075 BD Amsterdam, Netherlands Phone: +31 (0)13 - 79 99 040 (Europe) E-mail: [email protected] www.nonin.com

0123 EC

REP

MPS, Medical Product 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 those of their respective owners. © 2020 Nonin Medical, Inc. 114415-001-01

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 ... 10 Unpacking the WristOx2, Model 3150... 10 Standard Kit (USB or BLE) ... 10 Starter Kit (USB Only)... 10 Batteries ... 10 Bluetooth Technology (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 Operation... 28 Startup Sequence and Self-Test... 28 Error Codes ... 29 Troubleshooting... 30 Care and Maintenance ... 32 Cleaning the Device ... 32 Cleaning the Sensor ... 32 Cleaning the Multiple Use Wristband ... 32 Storing ... 32

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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 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 of Operation ...46 Specifications ...47 Oximeter Specifications ...47 System Specifications...47 ...48 Transmitter...49

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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. Thread Short Segment... 17 Figure 8. Secure Long Segment ... 18 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. Removal of Single Use Wristband ... 27 Figure 19. Apply Sensor to Patient... 27 Figure 20. nVISION Settings Window ... 35

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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

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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. The intended use environments are hospitals, medical facilities, ambulatory, subacute, sleep study environments, and mobile units.

Warnings Do not use this device in a Magnetic Resonance (MR) environment or in the presence of flammable anesthetics or gases. This device is not defibrillation proof per IEC 60601-1. This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. Check the pulse oximeter sensor application site every 4 hours to determine the positioning of the sensor and the circulation and skin sensitivity of the patient. Patient sensitivity varies depending on medical status or skin condition. Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor. Carefully route patient cables and connections to reduce the possibility of patient entanglement, strangulation, or injury to the patient. 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. 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 the batteries, make sure the device is off and the sensor is not applied to a digit. This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed carefully to verify normal operation. The use of accessories, sensors, and cables other than those listed in this manual may result in increased electromagnetic emission and/or decreased immunity of this device. Do not use the device when alarms are required. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor. This equipment complies with International IEC 60601-1-2 for electromagnetic compatibility (EMC) for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual.

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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. Otherwise, degradation of the performance of this equipment could result.

Cautions If this device fails to respond as described, refer to “Troubleshooting” or discontinue use until the situation has been corrected. Contact Nonin Technical Service. This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality. Do not place liquids on top of this device. When setting the clock in Programmed Activation Mode using nVISION software, verify all set times and dates are valid. Do not place the WristOx2, Model 3150, in liquid or clean it with agents containing ammonium chloride or isopropyl alcohol. Refer to the “Care and Maintenance” section of this operator’s manual. Use a detergent that is 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. After cleaning the multiple use wristband, it should only be applied to the same patient; do not apply it to a different patient. Follow local, state, and national governing ordinances and recycling 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 how to reach your distributor, please call Nonin for your distributor’s contact information. This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: - methemoglobin - incorrect sensor type - excessive ambient light - dysfunctional hemoglobin - poor pulse quality - excessive motion - artificial nails or fingernail - venous pulsations - electrosurgical interference polish - anemia or low hemoglobin - blood flow restrictors (arterial - residue (e.g., dried blood, dirt, concentrations catheters, blood pressure cuffs, grease, oil) in the light path - cardiogreen and other infusion lines, etc.) intravascular dyes - moisture in the sensor - carboxyhemoglobin - improperly applied sensor When using the monitor in the home, avoid exposing the monitor to lint and dust. When using the monitor around small children and pets, avoid leaving the monitor unattended. Cables pose a risk of injury, including strangulation. 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. Opening the case may damage the device and void the warranty. 2

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. 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. 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 may not work when circulation is reduced. Warm or rub the finger or reposition the sensor. A functional tester cannot be used to assess the accuracy of the oximeter or sensor. Do not fasten the device too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result. If the WristOx2, Model 3150 BLE is being used with wireless communication, use the device within its designated range of approximately 60 meters (spherical radius). Moving outside this range may cause loss of the wireless connection.. Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data transfer. If the time and date settings are lost while in Programmed Activation Mode, the device will revert to Spot Check Activation Mode. 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.

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, WristOx2 Pulse Oximeter, to which this declaration relates, complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. • Ministry of Health (Canada), Safety Code 6: standards include a substantial safety margin designed to ensure the safety of all persons, regardless of age and health. The exposure standard for wireless mobile phones employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg.

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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. If not installed and used in accordance with the instructions, it may cause harmful interference to radio or television reception, which can be determined by turning the device off and on. The user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the distance between the device and the receiver. • Connect the device to an outlet on a circuit different from the outlet where the receiver is connected. • Consult the dealer or an experienced radio/TV technician for assistance. • RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure guidelines, use only accessories that contain no metallic components. Use of other accessories may violate 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 both U.S. and international standards bodies. This device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general population exposure limits specified in 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.

Point-to-Point Communications (BLE Only) The WristOx2, Model 3150 BLE, features point-to-point communication and allows only one connection at a time. Once the 3150 BLE is in a connection, it will no longer be advertising and therefore is not available for an additional connection.

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CAUTION: If the WristOx2, Model 3150 BLE is being used with wireless communication, use the device within its designated range of approximately 60 meters (spherical radius). Moving outside this range may cause missing or lost data.

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!

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Follow Instructions for Use. Consult 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. Type BF-Applied Part (patient 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. Interference may occur in the vicinity of equipment marked with this symbol. UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards in accordance with: • ANSI/AAMI ES60601-1:2005/(R)2012 and CAN/CSA-C22.2 No. 606011:14 • ISO 80601-2-61:2017 • IEC 60601-1-11:2015

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Guide to Symbols

Table 1: Labeling Symbols (Continued) Symbol

Description

IP33

Protected against spraying water and against access to hazardous parts with a tool, per IEC 60529. Manufacturer

SN

Serial Number

REF

Catalogue Number

QTY

Quantity Date of Manufacture

US

Country of Manufacture Storage/shipping Temperature Range RoHS Compliant (China) Medical prescription required

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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.

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.

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Displays, Controls, and Indicators

Activation Switch The activation switch is located next to the sensor port at the top of the WristOx2, 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). It also displays when the finger is removed from the sensor.

Pulse Strength Indicator A pulse strength indicator displays when the device is recording data. The number bars on the display depends on the pulse strength as determined by the oximeter. Full and Partial Display Mode

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 Display Mode

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 “Memory Volume (MVI) Display Mode” on page 13.

Poor Pulse Signal Indicator This indicator displays when the pulse signal is inadequate or the device does not sense a pulse. It may also display if there is excessive motion at the sensor site.

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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.

Bluetooth Indicator (BLE Model only) The Bluetooth indicator is used to show the following conditions: Bluetooth indicator

Bluetooth indicator with animated bars

• 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 radio is on and is connected to a collector.

SmartPoint Indicator This indicator displays during the startup sequence.

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Introduction

Introduction The WristOx2, Model 3150 pulse oximeter is a small, wrist-worn device that displays, measures, and stores patient SpO2 and pulse rate data and is capable of transmitting stored data via USB. 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. NOTE: If using the WristOx2, Model 3150 BLE with 3rd party software, please disregard nVISION information.

Unpacking the WristOx2, Model 3150 The WristOx2, Model 3150, standard or starter kit includes the items listed below. 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 • Carrying case (3150 USB Only)

Starter Kit (USB Only) A starter kit is required to configure the device and download data to a PC. The starter kit consists of the standard kit, plus: • 2 additional wristbands (3 total) • nVISION SpO2 data management software (CD) • Model 3150SC, PC USB interface cable

Batteries The device uses 2 AAA batteries. With new alkaline batteries, battery life is approximately 53 hours (minimum). When connected to a Bluetooth device, battery life will vary depending on class of operation. See “Specifications” for detailed battery life information. 10

Introduction

The battery indicator shows one of four states: full, half, low, and critical. Replace the batteries when the device reaches low state. A low battery has a minimum of 10 minutes before it reaches critical state. Actual battery life depends on Bluetooth radio use. In critical battery mode: • The battery indicator blinks. • The device no longer monitors or records patient data. • The clock settings are lost. 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. Use nVISION software to synchronize the clock and confirm the device is in the desired activation mode (see “Accessing nVISION Settings” on page 34). Remove the batteries and disconnect the sensor if the device is to be stored for more than 1 month. Do not store with batteries installed. NOTES: • This device contains non-volatile memory. Removing or replacing batteries does not affect the data stored in memory. Stored data remains in memory until overwritten by newer data or cleared from memory with nVISION software (version 6.5 or greater). • If batteries are replaced while recording data, the session 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 life. • If clock settings are lost, the date and time restarts at 01:01:10:00:00 (January 1st, 2010 at 12:00 a.m.).

Bluetooth Technology (3150 BLE only) Bluetooth technology allows wireless connections between electronic communications and computing devices. The technology is based on a radio link that offers fast and reliable data transmissions. Bluetooth uses a license-free, globally available frequency range in the ISM band-intended to ensure communication compatibility worldwide. Nonin’s use of Bluetooth wireless technology allows SpO2 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. Nonin’s WristOx2, Model 3150 BLE, uses a Bluetooth Low Energy radio with a maximum range (spherical radius) of about 60 meters (196 feet). Obstacles and other conditions may affect range and battery life. See “Specifications” for detailed battery life information.

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Modes

Modes The WristOx2, 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. It will turn off 10 seconds after the finger is removed. If the sensor is disconnected, the device turns off immediately. NOTE: If the device determines that a sensor fault exists (a sensor failure, misalignment, or incompatibility with the device) or if a pulse oximeter sensor signal cannot be detected, the device turns off after 3 minutes.

Sensor Activation Mode 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 patient (e.g., disposable 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 device will turn off. When off, the device will display the next session start time every 30 seconds. !

CAUTION: When setting the clock in Programmed Activation Mode using nVISION software, verify all session dates and times are valid.

A sensor must be connected to the 3150 in order for the 3150 to turn on at the programmed session time. Between the programmed sessions, pressing the activation switch will turn on the device for three minutes. During this time, the user is able to take and store measurements. After three minutes, the device will turn off. !

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CAUTION: A device in Programmed Activation Mode reverts to Spot Check Activation Mode if the clock is not set or if the clock settings are lost when replacing the batteries or due to critical battery level.

Modes

Display Modes Full Display Mode is the factory default.

Full Display Mode Full Display Mode will display SpO2, 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 SpO2 and the pulse rate readings do not display. The user will only see the battery indicator and the animated pulse strength indicator. See figure 2 below for display comparison with Full Display Mode.

Full Display

Partial Display

Figure 2: Comparison of Full and Partial Display Partial Display Mode is not supported in Spot Check 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: display range of 0 – 199 • minutes: display range of 0 – 59 • The battery indicator • The pulse strength indicator When the animated pulse strength indicator displays, the device is recording data. The number next to the indicator are the minutes of stored data, not the pulse rate. NOTE: When the device is in Memory Volume Display Mode, the %SpO2 and pulse rate readings do not display on the screen.

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Modes

Hours

Battery Indicator

Pulse Strength Indicator

Minutes

Figure 3: Memory Volume Display Mode The example in figure 3 shows a device with 10 hours and 56 minutes of stored data.

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