WristOx2 Model 3150 Operators Manual

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: [email protected] 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: [email protected] nonin.com

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EC

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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. © 2014 Nonin Medical, Inc. 9584-001-03

Contents Indications for Use ... 1 Contraindications... 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 ... 4 Point-to-Point Communications ... 5 Guide to Symbols... 6 Displays, Controls, and Indicators ... 7 Introduction ... 10 Unpacking the WristOx2, Model 3150... 10 Standard Kit ... 10 Starter Kit ... 10 Batteries ... 11 Bluetooth Technology... 11 Operation Modes ... 12 Cable ... 12 Standby ... 12 On... 12 Spot Check Mode ... 12 Sensor Activation Mode ... 13 Programmed Mode ... 13 Memory Volume (MVI) Display Mode ... 14 Using the WristOx2, Model 3150... 15 Installing Batteries ... 15 Attaching the Wristband ... 16 Wristband Description ... 16 Attaching the Sensor ... 19 Patient Application... 20 Verifying Operation... 23 Startup Sequence and Self-Test... 23 Activation Switch ... 24 Activate Bluetooth Radio... 24 Activate Device ... 24 Error Codes ... 24 Troubleshooting ... 25 Care and Maintenance ... 27 Cleaning the Device ... 27 Cleaning the Sensor ... 27

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Contents (continued) Cleaning the Wristband...27 Storing...27 Memory and Data ...28 nVISION Software ...29 nVISION Settings ...29 Accessing nVISION Settings ...29 Cable Connection...30 USB Driver Installation (XP SP3)...31 USB Driver Installation (Vista) ...32 USB Driver Installation (Windows 7)...32 USB Driver Installation (Windows 8)...33 Bluetooth Connection...33 Bluetooth Security...34 Connecting the Device into a Medical System ...34 Parts and Accessories ...35 Sensors ...35 Service, Support, and Warranty ...37 Service and Support...37 Warranty...37 Technical Information...38 Manufacturer’s Declaration ...38 Equipment Response Time...42 Testing Summary ...43 SpO2 Accuracy Testing ...43 Pulse Rate Motion Testing...43 Low Perfusion Testing ...43 Principles of Operation...43 Specifications ...44 Oximeter Specifications ...44 System Specifications...45 Transmitter...46

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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. Wristband ... 16 Figure 7. Thread Short Segment... 17 Figure 8. Secure Long Segment ... 17 Figure 9. Device with Wristband Attached (Front and Back Views) ... 18 Figure 10. Attach Sensor... 19 Figure 11. Thread and Tighten Wristband... 20 Figure 12. Fasten Wristband ... 21 Figure 13. Using the Rectangle Fastener... 21 Figure 14. Using the Square Fastener ... 22 Figure 15. Apply Sensor to Patient... 22 Figure 16. nVISION Settings Window ... 30

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Tables Table 1. Labeling Symbols... 6 Table 2. Error Codes... 24 Table 3. Electromagnetic Emissions... 38 Table 4. Electromagnetic Immunity... 39 Table 5. Guidance and Manufacturer’s Declaration-Electromagnetic Immunity... 40 Table 6. Recommended Separation Distances ... 41

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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, and sleep study environments, and mobile units.

Contraindications 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.

Warnings 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 6-8 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.

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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. 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. 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.

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 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 single-patient 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: - excessive ambient light - improperly applied sensor - cardiogreen and other - excessive motion - incorrect sensor type intravascular dyes - electrosurgical interference - poor pulse quality - carboxyhemoglobin - blood flow restrictors (arterial - venous pulsations - methemoglobin catheters, blood pressure cuffs, - anemia or low hemoglobin - dysfunctional hemoglobin infusion lines, etc.) concentrations - artificial nails or fingernail - moisture in the sensor polish 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 qualified technical professionals. 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.

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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. 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 is being used with wireless communication, use the device within its designated range of approximately 100 meters (spherical radius). Moving outside this range may cause missing or lost data. Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data transfer. Radios and cell phones or similar devices can affect the equipment and must be kept at least 2 meters (6.5 feet) away from 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.

NCC 警語低功率電波輻射性電機管理辦法第十二條經型式認證合格之低功率射頻電機，非經許可，公 司、商號或使用者均不得擅自變更頻率、加大功率或變更原設計之特性及功能。第十四條低功率 射頻電機之使用不得影響飛航安全及干擾合法通信；經發現有干擾現象時，應立即停用，並改善 至無干擾時方得繼續使用。前項合法通信，指依電信規定作業之無線電信。低功率射頻電機須忍 受合法通信或工業、科學及醫療用電波輻射性電機設備之干擾 在 5.25-5.35 秭赫頻帶?操作之無線資訊傳輸設備，限於室?使用。

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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. Nonin’s use of Bluetooth wireless technology allows SpO2, pulse rate, and plethysmographic data to be transmitted through a Bluetooth radio to a compatible Bluetooth-enabled device. Nonin’s system removes the connection from the sensor cable to the display device, giving patients increased ability to move freely-without being hindered by cables. Nonin’s patient module uses a Bluetooth radio with a range of about 100 meters (328 feet) (spherical radius).

100 m

100 m

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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.

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CAUTION: If the WristOx2, Model 3150 is being used with wireless communication, use the device within its designated range of approximately 100 meters (spherical radius). Moving outside this range may cause missing or lost data.

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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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Consult Instructions for Use. Follow Instructions for Use. EC

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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.

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Bluetooth® figure mark 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 only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1.

IP33

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

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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 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). 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 14.

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. • The device reverts to Spot Check mode.

Bluetooth Indicator

Bluetooth indicator

Bluetooth indicator with animated bars

This indicator displays when the Bluetooth radio is on. It appears as either the Bluetooth logo or the Bluetooth logo with animated bars. This indicator displays for the first 2 minutes the device is on. If a master device does not connect to the device in those 2 minutes, the Bluetooth radio shuts down and the icon no longer displays. When the device is connected to a master device, the indicator displays with animated bars. If the Bluetooth radio is on when the device enters Standby mode or connects to the USB interface cable, the Bluetooth indicator appears on the LCD while the Bluetooth radio shuts down. It will be the only indicator on the LCD and will display for up to 10 seconds.

SmartPoint Indicator This indicator displays during the startup sequence.

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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. 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. NOTE: If using the WristOx2, Model 3150 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 • 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 (on operator’s manual CD) – required to use the PC USB interface cable

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

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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. 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. • The device reverts to Spot Check mode. 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 change the operation mode (see “Accessing nVISION Settings” on page 29). Remove the batteries and disconnect the sensor if the device is to be stored for more than 1 month. In storage, battery life is approximately 9 months. 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 6.3 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. • If clock settings are lost, the date and time restarts at 01:01:10:00:00.

Bluetooth Technology 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. To make efficient use of battery life, Nonin’s WristOx2, Model 3150, uses an automatically switchable Class 1/Class 2 Bluetooth radio with a maximum range (spherical radius) of about 100 meters (328 feet). Obstacles and other conditions may affect range, and class of operation and connection mode will impact battery life. See “Specifications” for detailed battery life information. 11

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.

Standby When the device is in Standby mode, the screen is blank and the device appears to be off. In Standby, it is ready for a signal that will turn the device on (e.g., pressing activation switch, inserting finger in sensor [Spot Check mode], connecting sensor [Sensor Activation mode], or programmed start time [Programmed mode]). While in Standby mode, the device does not collect or save data and the Bluetooth radio is off.

On When the device is on, it can collect and save data. The device features three turn on modes: • Spot Check mode • Sensor Activation mode • Programmed mode The device is delivered in Spot Check mode. nVISION software (version 6.3 or greater) is needed to access the device settings and change Spot Check mode to Sensor Activation or Programmed mode (see “nVISION Software”). nVISION software (version 6.4 or greater) is needed to access memory volume (MVI) display mode. The device recalls the active settings when the device is shut off and turned on again.

Spot Check Mode Spot Check mode is the default turn on operation mode. The device automatically turns on when a finger is inserted into the sensor. It enters Standby mode 10 seconds after the finger is removed. If the sensor is disconnected, the device enters Standby mode immediately. In this mode, the sensor can be left connected to the device. 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 enters Standby mode after 3 minutes. 12

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. If the sensor is not used for at least 10 minutes or if an inadequate pulse signal is detected, the device automatically enters Standby mode. To turn the device on again, press the activation switch or disconnect and reconnect the sensor. This mode allows for Full or Partial display (see figure 2 for display comparison). When using Partial display, the SpO2 and pulse rate readings do not display. The user will only see the battery indicator and the animated pulse strength indicator.

Full Display

Partial Display

Figure 2: Comparison of Full and Partial Display

Programmed Mode Programmed mode may be selected and setup through nVISION software. With the software, the user can program the device to start and stop for up to three sessions. Once programmed, the next start time displays on the LCD every 30 seconds in HH:MM format.

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

A sensor must be connected for Programmed mode to function. If the programmed device is in Standby mode and the activation switch is pressed, the user activates the Bluetooth radio and the device for 3 minutes. During this time, the user is able to take and store measurements. After 3 minutes, the device returns to Standby mode. This mode allows for Full or Partial display (see figure 2 above for display comparison). When using Partial display, the SpO2 and pulse rate readings do not display. The user will only see the battery indicator and the animated pulse strength indicator. NOTE: A programmed device reverts to Spot Check mode if the clock is not set or if the clock settings are lost when replacing the batteries.

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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). 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.

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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