Respironics WristOx User manual

Operator’s Manual
Wrist Oximeter
WristOx
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.
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
Respironics Phone: [phone]
1001 Murry Ridge Lane Website: www.respironics.com
Murrysville, Pennsylvania 15668-8550 USA

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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 2601-1 and CAN/CSA C22.1 No. 601.1.
!
C
L
A
S
S
I
F
I
E
D
US
CUL

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Serial Number
Detailed information for functional symbols can be found in “Using the WristOx.”
Symbol Description
SN

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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 con-
junction 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 manufac-
tured 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 electromag-
netic 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 equip-
ment and other sources of electrical noise in healthcare and other environments (for exam-
ple, 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 recy-
cling 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 func-
tional 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 SpO2measurement.
• 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 (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
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. Remove the old batteries and discard or recycle them according to local governing
ordinances.
3. Insert two new 1.5V alkaline N-cell batteries. Correct battery positioning is essential for proper
operation.
4. Carefully re-position the battery door. Do not force the door into place; it fits only
when positioned properly.
5. If the WristOx does not turn on when a sensor is plugged into the unit, reinsert the
batteries or refer to “Troubleshooting.”

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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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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 Respironics
Customer Service for assistance.
NOTE: If the device cannot track the pulse or finger removal is not detected, the
WristOx will shut off automatically after 3 minutes.

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Attaching the Sensor
Use the following procedure to attach the sensor and begin taking %SpO2 readings.
1. Apply the wrist band securely and comfortably around the patient’s wrist.
2. Place the patient’s finger inside the sensor. Refer to the respective sensor instructions
for specific information about placement and patient safety.
3. 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: 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.

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System Features
%SpO2Display
Numeric indicators on the upper left-hand corner of the WristOx display blood oxygen satu-
ration in percent (indicated by the %SpO2icon).
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.