Respironics WristOx Operator's Manual

Operator’s Manual
WristOx
Wrist Oximeter
TM
English
CAUTION! U.S. federal law restricts this device to sale by or on the order of a physician. WARNING! Read this entire manual carefully before using the WristOx.
The information in this manual has been checked carefully and is believed to be accurate. In the interest of continued product development, Respironics reserves the right to make changes and improvements to this manual and the products it describes at any time, without notice or obligation.
Respironics Phone: 800-345-6443 1001 Murry Ridge Lane Website: www.respironics.com Murrysville, Pennsylvania 15668-8550 USA
References to “Respironics” in this manual imply Respironics, Inc. Respironics is a registered trademark of Respironics, Inc. References to “NONIN” in this manual imply Nonin Medical, Inc. Nonin is a registered trademark of Nonin Medical, Inc. WristOx™ is a trademark of Nonin Medical, Inc.
©2004 Respironics

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).
I
S
F
S
I
E
A
D
L
C
U
C
L
US
UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 2601-1 and CAN/CSA C22.1 No. 601.1.
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Detailed information for functional symbols can be found in “Using the WristOx.”
Symbol Description
SN
Serial Number
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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

• Read this entire manual carefully before using the WristOx.
• 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).
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• 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.
• Use only Respironics-manufactured pulse oximeter sensors. These sensors are manufac­tured to meet the accuracy specifications for Respironics 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.
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Cautions

• U.S. federal law restricts this device to sale by or on the order of a physician.
• 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 Respironics Customer Service 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 (for exam­ple, cellular phones, mobile two-way radios, electrical appliances), it is possible that high
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levels of such interference due to close proximity or strength of a source might disrupt the performance of this device.
• 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 Respironics personnel only.
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• 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 might misinterpret motion as good pulse quality. Minimize patient motion as much as possible, or change the type of sensor being used.
• 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 SpO
measurement.
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• Some nail polish colors or artificial nails can reduce light transmission and affect SpO2 accuracy.
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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:
• WristOx™ Wrist Oximeter
Two 1.5V Alkaline N-cell Batteries
• WristOx Operator’s Manual
• Fingerclip Sensor
• 1 Reusable Wristband
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Using the WristOx

Indications for Use

The Respironics® 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.
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 nVISION more about using the WristOx with nVISION software.
®
software (version 5.0 or greater). See “Accessing Advanced Features” to learn
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)
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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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