WristOx Model 3100 Operators Manual

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.

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C

SSIFIE LA

D

C

Type BF Applied Part (Patient isolation from electrical shock). UL US

0123

SN

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. 601.1. CE Marking indicating conformance to EC directive No. 93/42/EEC concerning medical devices. Serial Number Indicates separate collection for electrical and electronic equipment (WEEE).

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.

Warnings • The WristOx is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. • General operation of the WristOx might be affected by the presence of an electrosurgical unit (ESU). • As with all medical equipment, carefully route patient cables and connections to reduce the possibility of patient entanglement or strangulation. • Use the WristOx only within the specified temperature ranges: +32°F to +122°F (0°C to 50°C) for operating, and 14°F to 122°F (-10°C to +50°C) for storage and transportation.

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• Use only NONIN-manufactured 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. • Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material. • Do not stretch the adhesive tape while applying the pulse oximeter sensor. • Ensure that the wrist band fits comfortably on the patient’s arm. Do not over-tighten the wrist band. • Pulse oximeter readings might be affected while patients are being defibrillated. • 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 emission and/or decreased immunity of this device.

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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. • Verify that all visible indicators appear during the start-up (initialization) sequence. If any indicator does not appear, do not use the WristOx. Contact NONIN Customer Support for assistance. • This equipment complies with International Standard EN 60601-1-2:2001 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

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• • • • • • • • •

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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. Do not remove any covers other than the battery cover when replacing batteries. There are no user-serviceable parts inside. Batteries might leak or explode if used or disposed of improperly. Follow local governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. Do not immerse the WristOx or sensors in water or any other liquids. Do not place or pour liquids on top of the WristOx. The WristOx is a precision electronic instrument. It must be repaired by trained NONIN personnel only. The WristOx is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin may affect the accuracy of the measurement.

• 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. Patient sensitivity varies depending on medical status or skin condition. • Cardiogreen and other intravascular dyes, depending upon their concentrations, might affect the accuracy of the SpO2 measurement. • This device has not been tested for immunity to electromagnetic disturbances. • Some nail polish colors or artificial nails can reduce light transmission and affect SpO2 accuracy. • 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.

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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: • • • • •

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Model 3100 Wrist Oximeter Two 1.5V Alkaline N-cell Batteries

WristOx Operator’s Manual 8000AA-WO Fingerclip Sensor 1 Reusable Wristband

Using the WristOx 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 (SpO2) 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. WARNING!

Do not use the WristOx when alarms are required!

The WristOx comes packaged in Spot Check mode. In Spot Check mode, inserting a finger in the sensor turns on the WristOx automatically, and removing a finger turns off the WristOx automatically. Advanced memory and programming features are only available with NONIN’s nVISION® software (version 5.0 or greater). See “Accessing Advanced Features” to learn more about using the WristOx with nVISION software.

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Installing the Batteries 1.

Use your thumb to loosen the lower front cover of the WristOx, and carefully remove the battery door by sliding it downward.

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+ +

2. 3. 4. 5.

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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. Do not force the door into place; it fits only when positioned properly. If the WristOx does not turn on when a sensor is plugged into the unit, reinsert the batteries or refer to “Troubleshooting.”

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. Stored data will remain in memory until overwritten by newer data or cleared from memory with nVISION software (version 5.0 or greater).

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Setting Up the WristOx and Attaching the Sensor Use the following procedure to thread the wrist strap, attach the sensor, and begin taking %SpO2 readings. .

1.

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Begin threading the short segment of the wrist strap through the spring bars on the rear of the WristOx. As illustrated above, the spring bar near the top of the WristOx should be threaded first.

2.

Continue threading the wrist strap until it is pulled securely through both spring bars on the rear of the WristOx.

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3.

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Press the long segment of the wrist strap securely against the already-threaded strap. The WristOx is now securely mounted on the wrist strap.

4.

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.

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5.

Apply the wrist band securely and comfortably around the patient’s wrist.

6.

Place the patient’s finger inside the sensor. Refer to the respective sensor instructions for specific information about placement and patient safety.

NOTE:

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In Spot Check mode (default), the patient finger acts as the ON/OFF switch. See “Accessing Advanced Features” for more information about other modes that are available with the WristOx.

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.

NOTE:

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If the device cannot track the pulse or finger removal is not detected, the WristOx will shut off automatically after 3 minutes.

System Features %SpO2 Display

Numeric indicators on the upper left-hand corner of the WristOx display blood oxygen saturation in percent (indicated by the %SpO2 icon).

Pulse Rate Display The pulse rate display is the lower numeric display on the left side of the WristOx (identified by the

symbol). This 3-digit indicator display shows the pulse rate in beats per minute.

Pulse Oximeter Sensor Indicator The Pulse Oximeter Sensor Indicator indicates when a sensor has become disconnected, has failed, or has not been applied correctly.

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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 display solid.

Battery Indicator Any time the WristOx batteries are low or critical, this Indicator blinks, providing early warning to replace them. After critical battery capacity is met, the display turns off and monitoring is stopped.

Numeric Indicators Numeric Indicators appear after an %SpO2 or pulse rate reading is complete, providing results of the measurement.

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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 management and oximetry screening tool that allows users to record, transfer, analyze, report, and archive patient data. nVISION is compatible with many NONIN pulse oximeter models. NOTE:

Data is stored in the WristOx regardless of which mode the device is in.

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