Nonin Medical SABER SABER User Manual Model 3150 WristOx2 Pulse Oximeter
Nonin Medical, Inc. SABER Model 3150 WristOx2 Pulse Oximeter
Contents
- 1. Users Manual Info
- 2. Users Manual Additional Info
- 3. User Manual
User Manual
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| Document ID | 1328200 |
| Application ID | 1j9U8BWoRCzazTSvVveXGA== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 485.39kB (6067324 bits) |
| Date Submitted | 2010-08-17 00:00:00 |
| Date Available | 2010-08-17 00:00:00 |
| Creation Date | 2010-07-29 07:36:41 |
| Producing Software | Acrobat Distiller 9.3.0 (Windows) |
| Document Lastmod | 2010-07-29 09:27:38 |
| Document Title | Model 3150, WristOx2 Pulse Oximeter |
| Document Creator | FrameMaker 9.0 |
| Document Author: | Nonin Medical |
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: mail@nonin.com 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, and nVISION 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. © 2010 Nonin Medical, Inc. 7622-001-01 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 Federal Communications Commission (FCC) Notice............................................. 3 Guide to Symbols...................................................................................................... 4 Displays, Controls, and Indicators .......................................................................... 5 Introduction ............................................................................................................... 8 Unpacking the WristOx2, Model 3150 .................................................................... 8 Standard Kit ....................................................................................................... 8 Starter Kit .......................................................................................................... 8 Batteries ................................................................................................................ 9 Bluetooth Technology............................................................................................ 9 Operation Modes ..................................................................................................... 10 Cable ................................................................................................................... 10 Standby .............................................................................................................. 10 On........................................................................................................................ 10 Spot Check Mode ............................................................................................ 10 Sensor Activation Mode ................................................................................... 11 Programmed Mode .......................................................................................... 11 Using the WristOx2, Model 3150 ............................................................................ 12 Installing Batteries ............................................................................................... 12 Wrist Straps ......................................................................................................... 13 Ring Strap Description ..................................................................................... 13 Attach Ring Strap to Device............................................................................. 14 Adjustable Strap Description............................................................................ 15 Attach Adjustable Strap to Device ................................................................... 15 Attaching the Sensor ........................................................................................... 18 Patient Application............................................................................................... 19 Two-Piece Wrist Band Application ................................................................... 19 Single Strap Application ................................................................................... 21 Verifying Operation.............................................................................................. 24 Startup Sequence and Self-Test....................................................................... 24 Activation Switch ................................................................................................. 25 Activate Bluetooth Radio.................................................................................. 25 Activate Device ................................................................................................ 25 Error Codes ......................................................................................................... 25 Troubleshooting ..................................................................................................... 26 Care and Maintenance ............................................................................................ 28 Cleaning the Device ............................................................................................ 28 Cleaning the Sensor ............................................................................................ 28 Cleaning the Wrist Band...................................................................................... 28 Storing ................................................................................................................. 28 Contents (Continued) Memory and Data .....................................................................................................29 nVISION Software ....................................................................................................30 nVISION Settings ................................................................................................. 30 Accessing nVISION Settings ............................................................................ 30 Cable Connection................................................................................................. 31 USB Driver Installation (XP) ............................................................................. 32 USB Driver Installation (Vista) .......................................................................... 32 USB Driver Installation (Windows 7)................................................................. 33 Bluetooth Connection........................................................................................... 33 Parts and Accessories ........................................................................................... 35 Service, Support, and Warranty ............................................................................ 36 Service and Support............................................................................................. 36 Warranty............................................................................................................... 36 Technical Information............................................................................................. 37 Manufacturer’s Declaration ................................................................................ 37 Equipment Response Time................................................................................ 40 Testing Summary ............................................................................................... 41 SpO2 Accuracy Testing .................................................................................. 41 Pulse Rate Motion Testing.............................................................................. 41 Low Perfusion Testing .................................................................................... 41 Specifications ..................................................................................................... 42 Oximeter Specifications .................................................................................. 42 System Specifications..................................................................................... 43 Transmitter ..................................................................................................... 44 ii Figures Figure 1. Front Display (Startup Screen).............................................................. 5 Figure 2. Comparison of Full and Partial Display ................................................ 11 Figure 3. Remove Battery Door.......................................................................... 12 Figure 4. Insert Batteries .................................................................................... 12 Figure 5. Ring Strap ........................................................................................... 13 Figure 6. Thread Ring Strap............................................................................... 14 Figure 7. Attach Ring Strap ................................................................................ 14 Figure 8. Adjustable Strap.................................................................................. 15 Figure 9. Thread Adjustable Wrist Strap ............................................................ 16 Figure 10. Attach Adjustable Wrist Strap ........................................................... 16 Figure 11. Device with Wrist Straps Attached (Front and Back Views).............. 17 Figure 12. Attach Sensor.................................................................................... 18 Figure 13. Verify Two-Piece Wrist Band Attachment ......................................... 19 Figure 14. Thread and Tighten Two-Piece Wrist Band ...................................... 20 Figure 15. Fasten Two-Piece Wrist Band........................................................... 20 Figure 16. Apply Sensor to Patient .................................................................... 21 Figure 17. Verify Single Strap Attachment ......................................................... 21 Figure 18. Thread Single Strap ......................................................................... 22 Figure 19. Tighten Single Strap.......................................................................... 22 Figure 20. Fasten Single Strap........................................................................... 23 Figure 21. Apply Sensor to Patient..................................................................... 23 Figure 22. nVISION Settings Window ................................................................. 31 Tables Table 1. Table 2. Table 3. Table 4. Table 5. Labeling Symbols .................................................................................. 4 Error Codes ......................................................................................... 25 Electromagnetic Emissions ................................................................. 37 Electromagnetic Immunity ................................................................... 38 Guidance and Manufacturer’s Declaration— Electromagnetic Immunity ................................................................ 39 Table 6. Recommended Separation Distances................................................. 40 iii Indications for Use Indications for Use The Nonin Model 3150, WristOx2™ 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 of adult and pediatric patients. It is intended for spot-checking and/or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The intended use environments are sleep and pulmonary rehab labs, surgical recovery, critical care, emergency room, long-term care, home use, 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 60601-1:1988/A2:1995 clause 17h. 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. Carefully route patient cables and connections to reduce the possibility of patient entanglement or strangulation. 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. 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. The USB cable must be unplugged from the device before replacing batteries. 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. 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. Indications for Use 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. 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. Do not place liquids on top of this device. 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. 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: • poor pulse quality • excessive ambient light • venous pulsations • excessive motion • anemia or low hemoglobin concentrations • electrosurgical interference • cardiogreen and other intravascular dyes • blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.) • carboxyhemoglobin • moisture in the sensor • methemoglobin • improperly applied sensor • dysfunctional hemoglobin • incorrect sensor type • artificial nails or fingernail polish Do not perform any testing or maintenance on this device while it is being used to monitor a patient. 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. Indications for Use 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. 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. 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. 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. ® 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. 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. 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 This heart-shaped indicator is followed by up to nine curved bars. The heart shape is always visible, and the number of curved bars on the display depends on the pulse strength as determined by the oximeter. 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. Battery Indicator Full Half Low Critical This indicator shows remaining battery life as either full, half, low, and critical (as shown at left). Replace the batteries when device reaches low state. When the battery reaches critical state, all indicators clear from the display except for the blinking critical battery indicator, the current session closes, and the Bluetooth radio shuts down. Displays, Controls, and Indicators Bluetooth Indicator This indicator displays when the Bluetooth radio is on. It appears as either the Bluetooth logo or the Bluetooth logo with animated bars. Bluetooth indicator Bluetooth indicator 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. 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. 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 • 3 two-piece wrist bands, 1 each of the following: • 6 in. (15 cm) • 8 in. (20 cm) • 10 in. (25 cm) • 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: • 9 pack of two-piece wrist bands, 3 each of the following: • 6 in. (15 cm) • 8 in. (20 cm) • 10 in. (25 cm) • nVISION SpO2 data management software (CD) • PC USB interface cable 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 and the device no longer monitors or records patient data. When batteries are removed, the device maintains the time and date for up to 30 seconds. If replacing batteries takes more than 30 seconds, or if the battery level is at or below the critical level, clock settings are lost and the device reverts to Spot Check mode. Use nVISION software to reset the clock and change the operation mode. 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. 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. 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 higher) is needed to access the device settings and change Spot Check mode to Sensor Activation or Programmed mode (see “nVISION Software”). 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. 10 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. 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. 11 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 1. Open the battery compartment by sliding the battery door off the back of the device (figure 3). Figure 3: Remove Battery Door 2. Insert 2 new AAA alkaline batteries (figure 4). Battery orientation is shown inside the battery compartment. Figure 4: Insert Batteries 3. Replace battery door by sliding it back into place. 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, the device maintains the time and date for up to 30 seconds. If replacing batteries takes more than 30 seconds, or if the battery level is at or below the critical level, the operation mode reverts to Spot Check mode. Use nVISION software to reset the clock and change the operation mode. 12 Using the WristOx2, Model 3150 Wrist Straps The WristOx2, Model 3150, is designed to be applied to the patient’s wrist using a twopiece wrist band. The two-piece wrist band consists of a ring strap and an adjustable strap. For pediatrics and petite adults, the device may be applied using a single adjustable strap. The single adjustable strap is the longer of the two straps in the two-piece wrist band package. Straps have hook and loop fasteners on one side. The other side has a smooth, woven fabric. When the straps are attached to the device, the woven side should touch the patient’s skin. NOTE: A wrist strap has a maximum of 10 uses before replacement is required. This section contains descriptions of the straps and instructions for attaching the straps to the device. See the “Patient Application” section for instructions on how to apply the device to the patient. Ring Strap Description One end of the ring strap has a plastic ring. The square end has a hook and loop fastener (figure 5). The square end attaches to the strap bar at the top of the device, by the sensor port (see “Attach Ring Strap to Device”). Hook and Loop Side Attach this end to strap bar by sensor port Fastener Woven Side Figure 5: Ring Strap 13 Using the WristOx2, Model 3150 Attach Ring Strap to Device 1. Place device face down. 2. Locate strap bar at top of device (by sensor port). 3. Position ring strap so hook and loop side of strap faces up. 4. Thread square end fastener through the strap bar by the sensor port. Start from the back of the device and thread it towards the front of the device (figure 6). Strap bar at top of device (by sensor port) Figure 6: Thread Ring Strap 5. Fold strap so fastener adheres to the strap (figure 7). Figure 7: Attach Ring Strap 6. Continue to “Attach Adjustable Strap to Device.” 14 Using the WristOx2, Model 3150 Adjustable Strap Description This strap is part of the two-piece wrist band and may also be used to apply the device using a single strap. The adjustable strap is available in various lengths (see “Parts and Accessories”). It has hook and loop fasteners at both ends (figure 8). The square end attaches to the strap bar at the bottom of the device, by the battery door (see “Attach Adjustable Strap to Device” section). Hook and Loop Side Attach square end to strap bar by battery door Square End Fastener Rounded End Fastener Woven Side Figure 8: Adjustable Strap Attach Adjustable Strap to Device 1. Place device face down. 2. Locate strap bar at bottom of device (by battery door). 3. Position adjustable strap so hook and loop side of strap faces up. 15 Using the WristOx2, Model 3150 4. Thread square end fastener through the strap bar by the battery door. Start from the back of the device and thread it towards the front of the device (figure 9). Strap bar by battery door Figure 9: Thread Adjustable Wrist Strap 5. Fold square end of strap so square end fastener adheres to the strap (figure 10). Figure 10: Attach Adjustable Wrist Strap 16 Using the WristOx2, Model 3150 6. Verify straps are attached properly (figure 11). The smooth, woven side of the strap should contact the patient. Front View Back View Figure 11: Device with Wrist Straps Attached (Front and Back Views) 17 Using the WristOx2, Model 3150 Attaching the Sensor When applying the device using a single strap, connect the sensor to the device after the device has been applied to the patient (see “Single Strap Application”). When using a two-piece wrist band, the sensor can be connected to the device before or after applying the device to the patient (see “Two-Piece Wrist Band Application”). The following steps apply to these Nonin sensors: • 8000SS-WO2, 8000SM-WO2, 8000SL-WO2 • 8000AA-WO2 • 8000J-WO2 If using another Nonin-branded sensor, use sensor adapter cable 3150I (see “Parts and Accessories”). CAUTION: 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. 1. Insert the sensor connector into the sensor port at the top of the device (figure 12). The Nonin logo on the sensor connector should face the front of the device. 2. Push the connector until it clicks into place. 3. The device is ready to use. Figure 12: Attach Sensor 18 Using the WristOx2, Model 3150 Patient Application The WristOx2, Model 3150, is usually worn on the back of a patient’s wrist. This section describes how to secure the device to a wrist using either the two-piece wrist band or a single strap. NOTE: Straps can be used to secure the device to an alternate location (e.g., the upper arm or a bed rail). See “Part and Accessories” for additional strap lengths. Two-Piece Wrist Band Application NOTE: Ensure the wrist band fits comfortably on the patient’s arm. Do not over-tighten the wrist band. 1. Verify the ring strap and the adjustable strap have been attached properly to the device (figure 13). If straps have not been attached to the device, see “Attach Ring Strap to Device” and “Attach Adjustable Strap to Device.” Front View Back View Figure 13: Verify Two-Piece Wrist Band Attachment 19 Using the WristOx2, Model 3150 2. Place the device on the back of the patient’s arm. 3. Thread the rounded end of the adjustable strap through the plastic ring on the ring strap. Pull the adjustable strap through the plastic ring until the device fits comfortably on the wrist (figure 14). Plastic Ring Fastener Figure 14: Thread and Tighten Two-Piece Wrist Band 4. Fold the adjustable strap back over the plastic ring and attach the fastener to the adjustable strap (figure 15). Figure 15: Fasten Two-Piece Wrist Band 5. Attach the sensor if it is not already connected (see “Attaching the Sensor”). 6. Apply the sensor to the patient (figure 16). Refer to the sensor Instructions for Use for proper sensor application sites and sensor application cautions and warnings. 20 Using the WristOx2, Model 3150 Figure 16: Apply Sensor to Patient 7. When in Spot Check mode, inserting a finger in the sensor automatically turns the device on. When the finger is removed, the device enters Standby mode in approximately 10 seconds. NOTE: Depending on the sensor and ambient light conditions, it may take up to 3 minutes for the device to enter Standby mode. 8. If the device does not turn on, verify battery orientation, operation mode, and sensor connection. Refer to “Troubleshooting” for additional information. Single Strap Application NOTE: Patients using a single strap may need assistance applying the device. NOTE: Ensure the wrist band fits comfortably on the patient’s arm. Do not over-tighten the wrist band. 1. Verify the adjustable strap has been attached to the device by the battery door (figure 17). If strap has not been attached, see “Attach Adjustable Strap to Device.” Front View Back View Figure 17: Verify Single Strap Attachment 21 Using the WristOx2, Model 3150 2. Place the device on the back of the patient’s arm and wrap the strap around the patient’s arm. 3. Thread the rounded end of the strap through the strap bar by the sensor port (figure 18). Start from the back of the device and pull it towards the front of the device. Figure 18: Thread Single Strap 4. Pull the strap through the strap bar until the device fits comfortably on the patient’s wrist (figure 19). Figure 19: Tighten Single Strap 22 Using the WristOx2, Model 3150 5. Fold the strap over the strap bar so the fastener attaches to the strap (figure 20). Figure 20: Fasten Single Strap 6. Attach the sensor by inserting the sensor connector into the sensor port at the top of the device. The Nonin logo on the sensor connector should face the front of the device. (See “Attaching the Sensor” for more information.) 7. Push the connector until it clicks into place. 8. Apply the sensor to the patient (figure 21). Refer to the sensor Instructions for Use for proper sensor application sites and sensor application cautions and warnings. Figure 21: Apply Sensor to Patient 9. When in Spot Check mode, inserting a finger in the sensor automatically turns the device on. When the finger is removed, the device goes into Standby mode in approximately 10 seconds. NOTE: Depending on the sensor and ambient light conditions, it may take up to 3 minutes for the device to enter Standby mode. 10. If the device does not turn on, verify battery orientation, operation mode, and sensor connection. Refer to “Troubleshooting” for additional information. 23 Using the WristOx2, Model 3150 Verifying Operation When the WristOx2, Model 3150, first turns on, it performs a startup sequence and selftest. 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. • After the device disconnects from nVISION (Bluetooth connection only). Verify all indicators display during the startup sequence. Indicators appear in the following order for 1 second each. Startup Sequence and Self-Test 1. r and the software revision level: 2. All display icons: 3. Date/time using 24-hour clock format (MM:DD:YY:HH:MM) (example shows 23 April 2010 at 5:57 p.m.): Month and Day (MM:DD) Year (YY) Hour and Minutes (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. 24 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. Activate Bluetooth Radio When the device’s Bluetooth radio is on, a master device can connect to it. If a connection is not made, the Bluetooth radio shuts down. Pressing the activation switch turns the Bluetooth radio on for 3 minutes. The device will remain on until the Bluetooth radio shuts down. For example, if in Sensor Activation mode, unplugging the sensor will not put the device in Standby. Activate Device When in Sensor Activation mode, the device enters Standby mode after 10 minutes without a signal. Pressing the activation switch allows the user to turn the device on without disconnecting and reconnecting the sensor. Error Codes This device includes error codes that indicate problems with the unit. When an error occurs, the device displays the letters “Er” and a two-digit code (table 2). Table 2: Error Codes Error Code Description 01 Configuration sector error 02 Patient data pointer error 03 Main memory pointer error (Device memory is intact; however, the most recent session may be missing from the device.) 04 Data format 13 stored packet pointer error 05 Main data format 13 pointer error (Device memory is intact; however, the most recent stored measurement may be missing from the device.) Some error codes may be corrected by the user. See “Troubleshooting” for more information. 25 Troubleshooting Troubleshooting Problem Possible Cause Possible Solution Device will not activate. 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 Device set in Partial Display do not display. mode. Use nVISION software to select Full Display mode. Reconnect sensor. Poor pulse signal indicator displays. Excessive patient motion. Reduce patient motion. Poor pulse signal indicator displays and pulse strength indicator shows two bars or less. Inadequate pulse signal. Reposition or replace sensor, or place sensor on a different finger. Hands are cold. Warm sensor application site. No pulse display on pulse strength bar graph indicator. Sensor applied incorrectly. Refer to sensor Instructions for Use for proper sensor application. Device needs repair. Contact Nonin Technical Service. Remove and reconnect sensor. Possible interference from blood Reduce or eliminate restriction. flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.). Reduced circulation due to excess Check sensor alignment, reposition pressure from sensor. sensor, verify correct sensor size. Excessive ambient light. 26 Shield sensor from light source. Check sensor alignment. Troubleshooting Problem Possible Cause Possible Solution No pulse display on Sensor applied to polished or pulse strength artificial nail. indicator (continued). Sensor Light-Emitting Diode (LED) is not lit. Remove fingernail polish or an artificial nail. Er 01 displays on LCD. 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. Device configuration memory failure. 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. Device memory intact, but device may have lost most recent session or stored data. If error code continues, contact Nonin Technical Service. Dashes continually display on LCD. Sensor malfunction. Replace sensor with a Nonin-branded sensor. Device does not record in Programmed mode. Data collection start and stop times are set incorrectly. Use nVISION software to program correct start and stop times. Clock settings are lost after replacing batteries. Use nVISION software to reset clock. Device is out of range. Verify device is in range while being paired (approximately 100 meters [328 feet] spherical radius). Bluetooth radio has timed out. Press activation switch to turn on Bluetooth radio. Devices will not pair. If these solutions do not correct the problem, please contact Nonin Technical Service at (800) 356-8874 (USA and Canada) or + 1 (763) 553-9968. 27 Care and Maintenance Care and Maintenance The device requires no calibration or maintenance other than battery replacement. Cleaning the Device Wipe the device with a soft cloth dampened with a 10% bleach solution. 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. Clean once per week or more frequently if handled by multiple users. CAUTION: Do not place the WristOx2, Model 3150, in liquid or clean it with agents containing ammonium chloride or isopropyl alcohol. Cleaning the Sensor Refer to the sensor Instructions for Use for cleaning information. Cleaning the Wrist Band The wrist band is designed for single-patient use and may be used up to 10 times. If it needs to be cleaned, hand wash with a mild detergent (see note) in cool water (30 °C/ 86 °F). Allow to air dry. Do not machine wash or dry. The wrist band will shrink if placed in a dryer. NOTE: Mild detergents, such as hand and dish washing liquid detergents, dissolve dirt and grease. To clean washable surfaces, use in a solution of warm water. CAUTION: 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. Storing Store the device within the stated environmental specifications. See “Specifications” for additional information. Remove the batteries and disconnect the sensor if it is to be stored for more than 1 month. 28 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. Each time the device turns on, the current oximeter time and date (if the clock is set properly) are stored in memory to allow quick differentiation of recording sessions. Patient SpO2 and pulse rate are stored every 4 seconds (default), or every 1 or 2 seconds if programmed using nVISION software. The oxygen saturation values are stored in 1% increments in the range of 0 to 100%. 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. NOTE: Downloading data in memory does not clear memory. To clear memory, see “nVISION Settings.” 29 nVISION Software nVISION Software Nonin’s nVISION software (version 6.3 or greater) works with Microsoft Windows® 2000/ XP/Vista/7 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 Settings The following WristOx2, Model 3150, settings are programmed using nVISION: • Date and time – 24-hour clock format • Display options – allows clinicians to choose the best display option for each patient: • Full display shows %SpO2 and pulse rate data • Partial display shows pulse strength indicator, but not %SpO2 and pulse rate data • Patient data storage (sample) rate – 1, 2, or 4 seconds • Operation Modes – Sensor Activation, Spot Checking, and Programmed (see “Activation Options”) • Patient ID – up to 50 alphanumeric characters • Bluetooth Radio – disable at startup • Synchronize device time/date to the PC time/date • Download and save patient data to a PC • Clear device memory To access nVISION settings, connect the device to a PC using either the PC USB interface cable or a Bluetooth connection. Accessing nVISION Settings 1. Connect the device to a PC using the USB interface cable (see “Cable Connection”) or Bluetooth (see “Bluetooth Connection”). 2. Open nVISION. 3. Click the Data Capture icon, or select New Data Capture from the File drop down menu. 4. Select 3150 from the list of oximeters. 5. Click Settings. 6. “Enter Wrist Oximeter Settings” window opens (figure 22). Update or change settings as needed. 7. Click OK. 8. For more information, see nViSION Help. 30 nVISION Software Figure 22: nVISION Settings Window Cable Connection 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. The USB driver software for the cable needs to be installed before the device can connect to the PC. The software is located in the USB Driver folder on the Operator’s Manual CD. 1. Install USB driver if needed. See appropriate “USB Driver Installation” section for more information. 2. Connect the cable to the USB port on the PC. 3. Connect the cable to the device’s sensor port. 31 nVISION Software 4. When the device is ready to use with nVISION, these indicators display on the LCD: • CP • Battery indicator 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) 1. The USB driver software is on the Operator’s Manual CD. Insert the CD into the PC’s CD-DVD drive. 2. Connect the USB cable to the sensor port on the device and a USB port on the PC. 3. The Found New Hardware wizard opens and asks if Windows should connect to Windows Update to search for software. Select No, not this time and click Next. 4. Select Install from a list or specific location (Advanced) and click Next. 5. When asked to choose search and installation options: a. Select Search for the best driver in these locations. b. Unselect Search removable media c. Select Include this location in the search: d. Browse to the USB Driver folder on the Operator’s Manual CD and click OK. e. Click Next. 6. If the Hardware Installation/Windows logo testing window appears, click Continue Anyway to continue the installation. 7. When the wizard is done with the software installation, click Finish. 8. Look up the communications (comm or COM) port for the device: a. Click Start / Settings / Control Panel. b. Select System. System Properties window opens. c. On the Hardware tab, select Device Manager. d. 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 device with nVISION. 32 nVISION Software USB Driver Installation (Vista) 1. Connect the USB cable to the sensor port on the device 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 Operator’s Manual CD. Insert the CD into the PC’s CD-DVD drive and click Next. 5. Update Driver Software - Model 3150 window opens. Choose Browse my computer for driver software. 6. Browse to the USB Driver folder on the Operator’s Manual CD and click OK. 7. Click Next. 8. In the Windows Security pop-up window, select Install this driver software anyway. 9. Driver software installs. When Windows has successfully updated the driver software, click Close. 10. Open the Device Manager by clicking Start / Control Panel / Device Manager. 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 device with nVISION. USB Driver Installation (Windows 7) 1. The USB driver software is on the Operator’s Manual CD. Insert the CD into the PC’s CD-DVD drive. 2. Connect the USB cable to the sensor port on the device and a USB port on the PC. 3. Open the Device Manager by clicking Start / Control Panel / System and then selecting Device Manager. 4. Expand Other devices. 5. Right click Model 3150 and select Update Driver Software... 6. Update Driver Software - Model 3150 window opens. Choose Browse my computer for driver software. 7. Browse to the USB Driver folder on the Operator’s Manual CD and click OK. 8. Click Next. 9. In the Windows Security pop-up window, select Install this driver software anyway. 10. Driver software installs. When Windows has successfully updated the driver software, click Close. 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 device with nVISION. 33 nVISION Software Bluetooth Connection NOTE: Etched onto the device is the word “pin” followed by a 6-digit number. This is the device’s unique identification number, also known as the Bluetooth Passkey or PIN Code. This number is used when pairing the device to the host system. Refer to the host system’s operator’s manual for additional information. Before a Bluetooth master device can connect with the WristOx2, Model 3150 (slave device), the devices must be paired. Once paired, the WristOx2, Model 3150, will automatically connect with the last paired master device when turned on or activated. 1. To connect the WristOx2, Model 3150, to a PC or another device using Bluetooth, see Nonin’s online Bluetooth Connection Tutorial: http://www.nonin.com/training/products/3150/bluetooth_connection_tutorial/ 2. When nVISION connects to the WristOx2, Model 3150, the device stops recording patient data and the following indicators display on the LCD: • CP • Battery indicator • Bluetooth icon with animated bars 3. For more information about nVISION, refer to nVISION Help. 34 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) or +1 (763) 553-9968. 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). Used with Microsoft Windows 2000/XP/Vista/7 operating systems. 3150I Sensor Adapter Cable. Used to connect 1-meter, 9-pin connector sensors to the WristOx2, Model 3150. For compatible 1-meter sensors, contact Nonin, your distributor, or visit www.nonin.com. 3150WB Two-piece Wrist Band. Available lengths: 6 in. (15 cm) 8 in. (20 cm) 10 in. (25 cm) 13 in. (33 cm) 3150WBE Wrist Band Extender, 5 in. (13 cm) Reusable Pulse Oximeter Sensors 8000AA-WO2 Adult Articulated Finger Clip Sensor 8000J-WO2 Adult Flex Sensor 8000SS-WO2 Soft Sensor Small 8000SM-WO2 Soft Sensor Medium 8000SL-WO2 Soft Sensor Large 35 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. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA (800) 356-8874 (USA and Canada) + 1 (763) 553-9968 Fax: + 1 (763) 553-7807 E-mail: info@nonin.com www.nonin.com Warranty NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the purchaser the Model 3150, WristOx2 Pulse Oximeter for 3 years from the date of purchase. NONIN shall repair or replace any WristOx2, 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. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any WristOx2, Model 3150, delivered to the purchaser that is found to be defective in any manner, whether such remedies be in contract, tort, or by law. This warranty excludes cost of delivery to and from NONIN. All repaired units shall be received by the purchaser at NONIN’s place of business. NONIN reserves the right to charge a fee for a warranty repair request on any unit found to be within specifications. The WristOx2, Model 3150, is a precision electronic instrument and must be repaired by knowledgeable and specially trained NONIN personnel only. Accordingly, any sign or evidence of opening the WristOx2, Model 3150, field service by non-NONIN personnel, tampering, or any kind of misuse of the WristOx2, Model 3150, shall void the warranty. All non-warranty work shall be performed according to NONIN standard rates and charges in effect at the time of delivery to NONIN. DISCLAIMER/EXCLUSIVITY OF WARRANTY: THE WARRANTIES IN THIS MANUAL ARE EXCLUSIVE, AND NO OTHER WARRANTIES OF ANY KIND, WHETHER STATUTORY, WRITTEN, ORAL, OR IMPLIED, SHALL APPLY. 36 Technical Information Technical Information Manufacturer’s Declaration Refer to the following table for specific information regarding this device’s compliance to IEC 60601-1-2. Table 3: Electromagnetic Emissions Emissions Test Compliance 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. RF Emissions CISPR 11 Group 2 This device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF Emissions CISPR 11 Class B Harmonic Emissions IEC 61000-3-2 N/A This device is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage N/A Fluctuations/ Flicker Emissions IEC 61000-3-3 37 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) IEC 61000-4-2 ±6 kV contact ±8 kV air Electrical Fast Transient/Burst IEC 61000-4-4 ±2 kV for power supply N/A lines ±1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode N/A Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 ±5% UT (>95% dip in UT) for 0.5 cycle ±40% UT (60% dip in UT) for 5 cycles ±70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec. N/A Mains power quality should be that of a typical commercial or hospital environment. Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. ±6 kV contact ±8 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, relative humidity should be at least 30%. NOTE: UT is the AC mains voltage before application of the test level. 38 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. 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. Recommended Separation Distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m 3 V/m d = 1.17 P 80 kHz to 800 MHz d = 1.17 P 800 MHz to 2.5 GHz d = 2.33 P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the symbol: NOTES: 1. At 80 MHz and 800 MHz, the higher frequency range applies. 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 39 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. Users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment. Separation Distance According to Frequency of Transmitter Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.17 P d = 1.17 P d = 2.33 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.73 1.2 1.2 2.3 10 3.7 3.7 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTES: 1. At 80 MHz and 800 MHz, the higher frequency range applies. 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Equipment Response Time 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 Example - SpO2 Exponential Averaging SpO2 decreases 0.75% per second (7.5% over 10 seconds) Pulse Rate = 75 BPM 40 Technical Information SaO2 Reference 4 Beat Average 100 95 90 SpO2 85 80 75 70 65 80.0 72.0 64.0 56.0 48.0 40.0 32.0 24.0 16.0 8.0 0.0 60 Time in seconds Specific to this example: • The response of the 4-beat average is 1.5 seconds. Testing Summary SpO2 accuracy and low perfusion testing was conducted by Nonin Medical, Inc., as described below. SpO2 Accuracy Testing SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, nonsmoking, light- to dark-skinned subjects during motion and no-motion conditions in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples measured over the SpO2 range of 70 - 100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment—Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. Pulse Rate Motion Testing This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter tester. This test determines whether the oximeter meets the criteria of ISO 9919:2005 for pulse rate during simulated movement, tremor, and spike motions. Low Perfusion Testing This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings at various SpO2 levels for the oximeter to read. The oximeter must maintain accuracy in accordance with ISO 9919:2005 for heart rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation). 41 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 Saturation Accuracy Armsa: 70 % to 100 % %SpO2: No Motion Motionb Low Perfusion 8000AA-WO2: ±2 units ±2 units ±2 units 8000J-WO2: ±3 units NA ±2 units 8000SM-WO2: ±2 units NA ±2 units Pulse Rate Accuracy: ±3 units ±3 units ±3 units Measurement Wavelengths and Output Powerc: Red: 660 nanometers @ 0.8 mW max. avg. Infrared: 910 nanometers @ 1.2 mW max. avg. a. ±1 Arms represents approximately 68% of measurements. b. SpO2 accuracy in motion specified for 8000AA-W sensor. c. This information is especially useful for clinicians performing photodynamic therapy. 42 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) 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 (1.5V) alkaline batteries Battery Life: Storage: Approx. 9 months Operating without Bluetooth: Approx. 48 hours (minimum) of continuous operation Operating with Bluetooth radio – Class 1a: Approx. 8 hours minimum Operating with Bluetooth radio – Class 2: Approx. 24 hours minimum Dimensions (without sensor or strap): 51 mm x 73 mm x 19 mm (H x W x D) (2.0 in. x 2.9 in. x 0.75 in.) Weight (with batteries and wrist strap): 64.0 g (2.3 oz) Memory: Type: Non-volatile Capacity: up to 1,080 hours (4 sec. data storage rate) up to 540 hours (2 sec. data storage rate) up to 270 hours (1 sec. data storage rate) Classification per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL60601-1: Type of Protection: Internally powered (battery power) Degree of Protection: Type BF-Applied Part Mode of Operation: Continuous Enclosure Degree of Ingress Protection: IP33 a. When operating with Bluetooth, typical battery life may vary depending on proximity to host connection and configuration of host-to-device communications. Times provided are minimum times for common configurations. 43 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 44
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