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Nonin 3100 WristOx Operator's Manual

Wrist oximeter
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Operator's Manual

WristOx
®
Wrist Oximeter
English
0123

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Summary of Contents for Nonin 3100 WristOx

  • Page 1 Operator’s Manual WristOx ® Wrist Oximeter English 0123...
  • Page 3 800-356-8874 (USA and Canada) Website: www.nonin.com Plymouth, MN 55441-5443 USA Fax: 763-553-7807 References to “NONIN” in this manual imply Nonin Medical, Inc. Nonin and WristOx are registered ® trademarks of Nonin Medical, Inc. VELCRO is a registered trademark of Velcro Industries, B.V.

  • Page 4: Guide To Symbols

    Guide to Symbols Detailed information for functional symbols can be found in “Using the WristOx.” Symbol Description Attention: See Instructions for Use or related materials. Type BF Applied Part (Patient isolation from electrical shock). UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 30EM and CAN/CSA C22.2 No.

  • Page 5: Precautions For Use

    Precautions for Use Read and follow all safety instructions before using the WristOx. Contraindications • Do not use the WristOx in a magnetic resonance imaging (MRI) environment. • Explosion Hazard: Do not use the WristOx in an explosive atmosphere or in the presence of flammable anesthetics or gases.
  • Page 6 • Use only NONIN-manufactured pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for NONIN pulse oximeters. Using other manufactur- ers’ sensors can result in improper pulse oximeter performance. • Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material.
  • Page 7 Cautions • Federal law (USA) restricts this device to sale by or on the order of a physician. • Read this entire manual carefully before using the WristOx. • Before using any sensor, carefully read the Directions for Use. • Do not, under any circumstances, perform any testing or maintenance on the WristOx while it is being used to monitor a patient.
  • Page 8 precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual. • Portable and mobile RF communications equipment can affect medical electrical equipment. • If the WristOx fails to respond as described, refer to “Troubleshooting” or discontinue use until the situation has been corrected by qualified personnel.
  • Page 9 • The WristOx has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In some circumstances, however, the WristOx may still interpret motion as good pulse quality. • Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and the circulation and skin sensitivity of the patient.
  • Page 10 Unpacking and Inspecting the WristOx Contact the carrier immediately if the shipping carton for the WristOx is damaged. Confirm that the items listed below are packed with the WristOx: • Model 3100 Wrist Oximeter • Two 1.5V Alkaline N-cell Batteries •...

  • Page 11: Indications For Use

    Indications for Use ® ® The NONIN Model 3100 WristOx pulse oximeter is a small, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute, and sleep study environments.

  • Page 12: Installing The Batteries

    Installing the Batteries Use your thumb to loosen the lower front cover of the WristOx, and carefully remove the battery door by sliding it downward. Remove the old batteries and discard or recycle them according to local governing ordinances. Insert two new 1.5V alkaline N-cell batteries. Correct battery positioning is essential for proper operation. Carefully re-position the battery door.

  • Page 13: Important Notes About Battery Use

    Important Notes about Battery Use The Battery Indicator will begin to flash approximately 30 minutes before entering critical battery mode. In critical battery mode, the WristOx no longer monitors or records patient data. Replace low batteries as soon as possible. NOTE: The WristOx contains non-volatile memory, so removing or replacing batteries will not affect the data stored in WristOx memory.
  • Page 14 Setting Up the WristOx and Attaching the Sensor Use the following procedure to thread the wrist strap, attach the sensor, and begin taking %SpO readings. Begin threading the short segment of the wrist strap through the spring bars on the rear of the WristOx.
  • Page 15 Continue threading the wrist strap until it is pulled securely through both spring bars on the rear of the WristOx.
  • Page 16 Press the long segment of the wrist strap securely against the already-threaded strap. The WristOx is now securely mounted on the wrist strap.
  • Page 17 Plug the sensor into the connector at the top of the WristOx, ensuring that all indicators appear during the first phase of the startup sequence. NOTE: When the sensor is completely connected, the red triangle on the sensor connector should not be visible.
  • Page 18 Apply the wrist band securely and comfortably around the patient’s wrist. Place the patient’s finger inside the sensor. Refer to the respective sensor instructions for specific information about placement and patient safety. NOTE: In Spot Check mode (default), the patient finger acts as the ON/OFF switch.
  • Page 20 Verifying WristOx Operation The WristOx performs an automatic startup (initialization) sequence and self-test when a sensor is plugged in. Verify that all indicators display during the first phase of the startup sequence. If any indicator is not displayed, do not use the WristOx. Contact NONIN Customer Support for assistance.

  • Page 21: System Features

    System Features %SpO Display Numeric indicators on the upper left-hand corner of the WristOx display blood oxygen satura- tion in percent (indicated by the %SpO icon). Pulse Rate Display The pulse rate display is the lower numeric display on the left side of the WristOx (identified by symbol).
  • Page 22 Pulse Strength Bargraph Indicator This 10-segment bargraph indicates pulse strength as determined by the oximeter. The height of the Pulse Strength Bargraph is proportional to the pulse amplitude. Pulse Quality Indicator This Indicator blinks to indicate a poor pulse. If there is a sustained series of poor pulses (approximately 10 seconds), the Pulse Quality Indicator will dis- play solid.

  • Page 23: Accessing Advanced Features

    Accessing Advanced Features To access additional modes of operation and advanced features for the WristOx, nVISION software (version 5.0 or greater) is required. nVISION is a flexible and convenient data man- agement and oximetry screening tool that allows users to record, transfer, analyze, report, and archive patient data.
  • Page 24 Using the WristOx with nVISION Software The WristOx can be used with nVISION software (version 5.0 or greater) to set various fea- ® tures and options according to user needs. A WristOx accessory package, which includes nVI- SION software and a computer cable, is available from NONIN. The following advanced settings can be programmed in WristOx with nVISION software: •...

  • Page 25: Activation Options

    Activation Options The WristOx features Spot Check mode, Sensor Activation mode, and Programmed mode. Spot Check Mode Spot Check mode is the WristOx default activation setting. In Spot Check mode, inserting a finger in the sensor turns ON the WristOx automatically, and removing a finger turns OFF the WristOx automatically.

  • Page 26: Programmed Mode

    Programmed Mode In Programmed mode, the WristOx turns on and off at user-defined intervals that are selected using nVISION software (version 5.0 or greater). Programmed mode allows users to select up to three start and stop times and dates. The sensor must be connected in order for Pro- grammed mode to function.
  • Page 27 Connecting the WristOx to a Computer To use the WristOx with nVISION software (version 5.0 or greater), a WristOx-compatible computer cable (Model 1000SC-WO) is needed. This cable can be connected to a computer for data downloading and editing with nVISION software. Use the instructions below to connect the WristOx to a computer: Connect the cable to the appropriate COM port on the computer.

  • Page 28: Memory Features

    Memory Features The WristOx collects and stores up to 33 hours of SpO and pulse rate information with a 4- second data storage rate. When the memory fills up, the unit begins overwriting the oldest data with the new data. Each time the WristOx is turned on, data are automatically collected in memory.
  • Page 29 Using a 2-second storage rate, data storage capacity is reduced to approximately 16 hours. Using a 1-second storage rate, data storage capacity is reduced to approximately 8 hours. The stored pulse rate ranges from 18 to 300 pulses per minute. The stored values are in incre- ments of one pulse per minute in the interval from 18 to 200 pulses per minute, and in incre- ments of 2 pulses per minute in the interval from 201 to 300 pulses per minute.
  • Page 30 Cleaning and Storing the WristOx NOTE: Do not immerse the WristOx in liquid, and do not use caustic or abrasive cleaning agents on the WristOx. Clean the WristOx separately from its associated sensors. For instructions regarding cleaning oximeter sensors, refer to the appropriate sensor package inserts. Clean the WristOx with a soft cloth dampened with isopropyl alcohol.

  • Page 31: Specifications

    Specifications OXIMETER SPECIFICATIONS 0% to 100% Oxygen Saturation Range (%SpO 18 to 300 pulses per minute Pulse Rate Range Displays Numeric Displays 3-digit Indicators Pulse Indicator Pulse Strength Bargraph Accuracy 70% to 100% ± 2 digits Blood Oxygen Saturation (%SpO ) (±...
  • Page 32 Altitude Up to 40,000 feet Operating Altitude Up to 4 atmospheres Hyperbaric Pressure SYSTEM SPECIFICATIONS Temperature +32° to +122°F (+0° to +50°C) Operating Storage/Transportation 14° to +122°F (-10° to +50°C) Humidity Operating 10% to 90% noncondensing 10% to 95% noncondensing Storage/Transportation Two 1.5V alkaline N-cell batteries Power Requirements...
  • Page 33 Storage 9 months 2 in H x 1.75 in W x 0.75 in D Dimensions (without sensor or strap) (5.08 cm H x 4.445 cm W x 1.905 cm D) ~0.88 oz. without batteries or wrist strap Weight (~24.95 g without batteries or wrist strap) Memory Nonvolatile Type...

  • Page 34: Parts And Accessories

    Parts and Accessories 3100CC WristOx Carrying Case 3100 Manual Operator’s Manual for the WristOx 1000SC-WO Computer cable Pulse Oximeter Reusable Sensors 8000AA-WO Adult Articulated Finger Clip Sensor 8000J-WO Adult Flex Sensor Other Accessories nVISION ® ® nVISION software (5.0 or greater) for Windows 95/98/00/NT 8000JFW Adult FlexiWrap Sensor Wrap...

  • Page 35: Service And Support

    For the sales representative or distributor in your area, contact NONIN at (800) 356-8874. A return authorization number is required before returning any product to NONIN. To obtain this return authorization number, contact NONIN’s Customer Support Department Nonin Medical, Inc. Phone: 763-553-9968 E-mail: mail@nonin.com 13700 1st Avenue North 800-356-8874 (USA and Canada) Website: www.nonin.com...

  • Page 36: Warranty

    Warranty NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the purchaser the pulse oximetry module of the Model 3100 for three years from the date of purchase. NONIN shall repair or replace any Model 3100 found to be defective in accordance with this warranty, free of charge, for which NONIN has been notified by the purchaser by serial number that there is a defect, provided said notification occurs within the applicable warranty period.

  • Page 37: Troubleshooting

    Troubleshooting Problem Possible Cause Possible Solution Device won’t activate. Batteries inserted wrong. Check batteries. Batteries are depleted. Replace batteries and try again. Sensor is disconnected. Re-connect sensor and try again. WristOx set in Programmed Use nVISION software to reset mode. WristOx in Spot Check or Sensor Activation mode.
  • Page 38 Problem Possible Cause Possible Solution No pulse display on Low patient pulse strength. Reposition or replace finger; keep bargraph. sensor motionless. Remove and re-connect sensor. Sensor applied incorrectly. Refer to sensor instructions to apply sensor correctly. Poorly perfused finger. Reposition or replace finger; keep sensor motionless.
  • Page 39 Problem Possible Cause Possible Solution No pulse display on Possible interference from: Reduce or eliminate interference. bargraph, cont’d. • arterial catheter • blood pressure cuff • electrosurgical procedure • infusion line Reduced circulation from Allow hand to rest without squeez- excess pressure on sensor.
  • Page 40 Problem Possible Cause Possible Solution No pulse display on Finger is cold. Warm the finger. bargraph, cont’d. Finger is wet. Dry the finger and inside of sensor. Indicator not lit in finger Call NONIN Customer Support. insertion area. Excessive patient motion. Reduce patient motion.
  • Page 41 Problem Possible Cause Possible Solution WristOx doesn’t Start and stop times set Use nVISION software to set start record in Pro- inconsistently. and stop times correctly. grammed mode. WristOx date and time set- Use nVISION software to set date tings are incorrect (or lost and time correctly.

  • Page 42: Manufacturer's Declaration

    Manufacturer’s Declaration Refer to the following table for specific information regarding this device’s compliance to IEC Standard 60601-1-2. Table 1: 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.

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