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.
5
Detailed information for functional symbols can be found in “Using the WristOx.”
Symbol Description
SN
Serial Number
6
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).
7
• 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.
8
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
9
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.
2
• Some nail polish colors or artificial nails can reduce light transmission and affect SpO2
accuracy.
11
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
12
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
13
)
2
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.
.
+
+
14
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 memor y 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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19
System Features
%SpO2 Display
Numeric indicators on the upper left-hand corner of the WristOx display blood oxygen saturation in percent (indicated by the %SpO
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.
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icon).
2
Pulse Oximeter Sensor Indicator
The Pulse Oximeter Sensor Indicator indicates when a sensor has
become disconnected, has failed, or has not been applied correctly.
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 bad pulse. If there is a sustained
series of bad pulses (approximately 10 seconds), the Pulse Quality
Indicator will display solid.
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22
Battery Indicator
Any time the WristOx batteries are low or critical, this Indicator blinks,
providing early warning to replace the batteries. 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.
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 Respironics pulse oximeter models.
NOTE: Data is stored in the WristOx regardless of which mode the device is in.
23
Using the WristOx with nVISION Software
The WristOx can be used with nVISION® software (version 5.0 or greater) to set various features and options according to user needs. A WristOx accessory package, which includes
nVISION software and a computer cable, is available from Respironics.
The following advanced settings can be programmed in the WristOx with nVISION software:
•Date •Time
• ID • Patient Data Storage Rate
• Display Options • Activation Options
In addition, information about device model number, revision, and parameters can be
retrieved; patient data can be downloaded and stored; WristOx memory can be cleared; and
the WristOx date and time can be synchronized to the date and time of the computer.
24
Full and Partial Display modes are also programmable with nVISION software. Partial Display mode can be used if visible %SpO
longer-term studies. In Partial Display mode, %SpO
and pulse rate data might add to patient anxiety in
2
and pulse rate data are not displayed on
2
the WristOx, but the Pulse Strength Bargraph is still visible.
25
Activation Options
The WristOx features three activation options: 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. In this mode, the sensor can be left attached (plugged in) to the
WristOx.
NOTE: If the device cannot track the pulse or finger removal is not detected, the
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WristOx will shut off automatically after 3 minutes.
Sensor Activation Mode
Sensor Activation mode can be selected with nVISION software (version 5.0 or greater). In
this mode, connecting and disconnecting the sensor from the WristOx functions like an ON/
OFF switch (whether or not a finger is in the sensor). In Sensor Activation mode, the
WristOx shuts off automatically after 30 minutes of no use or invalid pulse detection.
NOTE: When the WristOx shuts off automatically after 30 minutes, the sensor
must be unplugged and then reattached in order to turn on the WristOx.
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
Programmed mode to function.
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Connecting the WristOx to a Computer
To use the WristOx with nVISION software (version 5.0 or greater), a WristOx-compatible
computer cable (Model 1019443) is needed. This cable, available with the WristOx accessory
package, 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:
1. Connect the cable to the appropriate COM port on the computer.
2. Plug the cable to the top of the WristOx.
3. Wait until CP appears in the WristOx display. The WristOx is now ready for use with
nVISION software.
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Memory Features
The WristOx collects and stores up to 33 hours of SpO2 and pulse rate information with a 4-
second sample 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.
NOTE: Only recording sessions longer than one minute are stored.
Each time the WristOx is turned 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
SpO
and pulse rate are stored every four seconds (default), or every one or two seconds if
2
programmed using nVISION software (version 5.0 or greater). The oxygen saturation values
are stored in 1% increments in the range of 0 to 100%.
29
NOTE: Storage rates do not affect battery life; however, data storage capacity is
reduced when using a 1- or 2-second storage rate.
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 increments of one pulse per minute in the interval from 18 to 200 pulses per minute, and in increments of 2 pulses per minute in the interval from 201 to 300 pulses per minute.
NOTE: Playing back data in memory does not clear any data from memory.
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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. Do not pour or spray
any liquids onto the WristOx, and do not allow any liquid to enter any openings in the device.
Allow the WristOx to dry thoroughly before reusing.
Store the WristOx within the stated environmental specifications. See “Specifications” for
additional information.
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Specifications
OXIMETER SPECIFICATIONS
Oxygen Saturation Range (%SpO
Pulse Rate Range
Displays
Numeric Displays
Pulse Indicator
Accuracy
Blood Oxygen Saturation
(%SpO
) (± 1 S.D.)
2
Pulse Rate
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a
)
0% to 100%
2
18 to 300 pulses per minute
3-digit Indicators
Pulse Strength Bargraph
70% to 100% ± 2 digits
± 3%
Measurement Wavelengths and Output Power
Red
Infrared
Altitude
Operating Altitude
Hyperbaric Pressure
SYSTEM SPECIFICATIONS
Temperature
Operating
Storage/Transportation
660 nanometers @ 3 mw nominal
910 nanometers @ 3 mw nominal
Up to 40,000 feet
Up to 4 atmospheres
+32° to +122°F (+0° to +50°C)
14° to +122°F (-10° to +50°C)
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Humidity
Operating
Storage/Transportation
Power Requirements
Battery Life
Operating
Storage
Dimensions (without sensor or strap)
Weight
34
10% to 90% noncondensing
10% to 95% noncondensing
Two 1.5V alkaline N-cell batteries
minimum 24 hours of continuous operation
9 months
2 in H x 1.75 in W x 0.75 in D
(5.08 cm H x 4.445 cm W x 1.905 cm D)
~0.88 oz. without batteries or wrist strap
(~24.95 g without batteries or wrist strap)
Memory
Type
Capacity
CLASSIFICATIONS PER IEC 60601- 1 / CSA601.1 / UL2601-1
Type of Protection
Degree of Protection
Mode of Operation
a. S.D. (Standard Deviation) is a statistical measure; up to 32% of the readings may fall outside these limits.
Nonvolatile
33 hours @ 4 sec. data storage rate; 16 hours @
2 sec. rate; 8 hours @ 1 sec. rate
Internally powered (on battery power)
Type BF-Applied Part
Continuous
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Parts and Accessories
1019439 WristOx Travel Pack
1019488 WristOx User Manual
1019444 Oximeter Sensor Adapter
1019443 Oximeter Serial Cable
Pulse Oximeter Reusable Sensors
1019437 Adult Flex Sensor
1019522 WristOx Finger Clip Sensor
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1019441
Other Accessories
nVISION
®
software (version 5.0 or greater) for Microsoft Windows
95/98/00/NT
1019521 Sensor Attachment Tape, 100 per box
1019440 Wristband (10 pack)
1019438 Wristband Extender (10 pack)
1019448 WristOx 1.5v Alkaline Batteries (24 pack)
For more information about parts and accessories, contact Respironics at 800-345-6443.
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Service and Support
The WristOx Wrist Oximeter module performs all computations from internal software
stored in microprocessor chips. Thus, there are no critical parts to drift, and no calibration of
the pulse oximeter module is required.
For information about the WristOx and accessories, contact your local distributor or
Respironics Customer Service at (800) 345-6443.
Respironics Phone: 800-345-6443
1001 Murry Ridge Lane Website: www.respironics.com
Murrysville, Pennsylvania 15668-8550 USA
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Warranty
Respironics warrants to the purchaser the pulse oximetry module of the WristOx for three
years from the date of purchase.
Respironics shall repair or replace any WristOx found to be defective in accordance with this
warranty, free of charge, for which Respironics 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 WristOx 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 Respironics. All repaired units shall be
received by the purchaser at Respironics. Respironics reserves the right to charge a fee for a
warranty repair request on any unit found to be within specifications. The WristOx is a
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precision electronic instrument and must be repaired by knowledgeable and specially trained
Respironics personnel only. Accordingly, any sign or evidence of opening the WristOx, field
service by non-Respironics personnel, tampering, or any kind of misuse of the WristOx shall
void the warranty. All non-warranty work shall be done according to Respironics standard
rates and charges in effect at the time of delivery to Respironics.
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.
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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.
No %SpO
rate display.
or pulse
2
WristOx set in Programmed
mode.
WristOx set in Partial Display mode.
Use nVISION software to reset
WristOx in Spot Check or Sensor
Activation mode.
Use nVISION software to reset
WristOx in Full Display mode.
41
Problem Possible Cause Possible Solution
No pulse display on
bargraph.
Low patient pulse strength. Reposition or replace finger; keep
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.
Warm application site.
Finger positioned wrong. Reposition or replace finger; keep
sensor motionless.
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Problem Possible Cause Possible Solution
No pulse display on
bargraph, cont’d.
Possible interference from:
• arterial catheter
• blood pressure cuff
• electrosurgical procedure
• infusion line
Reduced circulation from
excess pressure on sensor.
Excessive ambient light. Shield sensor from light source.
Sensor applied to polished
or artificial nail.
Reduce or eliminate interference.
Allow hand to rest without squeezing or pressing sensor.
Apply sensor to finger without fingernail polish or an artificial nail.
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Problem Possible Cause Possible Solution
No pulse display on
bargraph, cont’d.
Pulse Oximeter Sensor indicator appears.
Finger is cold. Warm the finger.
Finger is wet. Dry the finger and inside of sensor.
Indicator not lit in finger
insertion area.
Excessive patient motion. Reduce patient motion.
Poor signal detected from
finger.
The WristOx needs repair. Call Respironics Customer Service.
Call Respironics Customer Service.
Reposition or replace finger; keep
sensor motionless.
Warm the application site.
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Problem Possible Cause Possible Solution
WristOx doesn’t
record in Programmed mode.
Start and stop times set
inconsistently.
Use nVISION software to set start
and stop times correctly.
WristOx date and time settings are incorrect (or lost
after removing batteries).
If these solutions do not correct the problem, please contact Respironics Customer Service at
800-345-6443.
4640-000-01 1019488
Use nVISION software to set date
and time correctly.
45
Manufactured by Nonin Medical, Inc. for Respironics, Murrysville.
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