perator’s Manual

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x®

English

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Wrist Oximete

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0123

y or on the order of a

he WristOx.

lieved to be accurate. In the inter-to make changes and improve-out notice or obligation.

Nonin and WristOx are registered ark of Velcro Industries, B.V.

Authorized EC Representative:, Medical Product Service GmbH

Borngasse 20D-35619 Braunfels, Germany

E-mail: mail@nonin.com ) Website: www.nonin.com

CAUTION! Federal law (USA) restricts this device to sale bphysician.

CAUTION! Read this entire manual carefully before using t

The information in this manual has been checked carefully and is beest of continued product development, NONIN reserves the right ments to this manual and the products it describes at any time, with

References to “NONIN” in this manual imply Nonin Medical, Inc. trademarks of Nonin Medical, Inc. VELCRO® is a registered tradem©2005 Nonin Medical, Inc.

MPS

Nonin Medical, Inc. Phone: 763-553-996813700 1st Avenue North 800-356-8874 (USA and CanadaPlymouth, MN 55441-5443 USA Fax: 763-553-7807

sing the WristOx.”

aterials.

th respect to electric shock, ith UL 60601-1 30EM and

ective No. 93/42/EEC

ctronic equipment

Guide to SymbolsDetailed information for functional symbols can be found in “U

Symbol Description

Attention: See Instructions for Use or related m

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

UL Mark for Canada and the United States wifire, and mechanical hazards only in accordance wCAN/CSA C22.2 No. 601.1.CE Marking indicating conformance to EC dirconcerning medical devices.

Serial Number

Indicates separate collection for electrical and ele(WEEE).

!

CLASSIFIED

USC UL

0123

SN

5

x.

MRI) environment. atmosphere or in the presence

sment. It must be used in con-symptoms. presence of an electrosurgical

and connections to reduce the

es: +32°F to +122°F (0°C to or storage and transportation.

Precautions for UseRead and follow all safety instructions before using the WristO

Contraindications• Do not use the WristOx in a magnetic resonance imaging (• Explosion Hazard: Do not use the WristOx in an explosive

of flammable anesthetics or gases.

Warnings• The WristOx is intended only as an adjunct in patient asses

junction with other methods of assessing clinical signs and • General operation of the WristOx might be affected by the

unit (ESU).• As with all medical equipment, carefully route patient cables

possibility of patient entanglement or strangulation.• Use the WristOx only within the specified temperature rang

50°C) for operating, and 14°F to 122°F (-10°C to +50°C) f

hese sensors are manufactured eters. Using other manufactur-nce.ts an allergic reaction to the

ximeter sensor. arm. Do not over-tighten the

e being defibrillated.other equipment. If adjacent or fully to verify normal opera-

listed in this manual may result evice.

6

• Use only NONIN-manufactured pulse oximeter sensors. Tto meet the accuracy specifications for NONIN pulse oximers’ sensors can result in improper pulse oximeter performa

• Discontinue use of adhesive tape strips if the patient exhibiadhesive material.

• Do not stretch the adhesive tape while applying the pulse o• Ensure that the wrist band fits comfortably on the patient’s

wrist band.• Pulse oximeter readings might be affected while patients ar• This device should not be used adjacent to or stacked with

stacked use is necessary, the device should be observed caretion.

• The use of accessories, sensors, and cables other than thosein increased emission and/or decreased immunity of this d

7

rder of a physician.

se.aintenance on the WristOx

initialization) sequence. If any NONIN Customer Support

0601-1-2:2001 for electromag- systems. This standard is nterference in a typical medical frequency transmitting equip- other environments, it is possi-ity or strength of a source rical equipment needs special

Cautions• Federal law (USA) restricts this device to sale by or on the o• Read this entire manual carefully before using the WristOx.• Before using any sensor, carefully read the Directions for U• Do not, under any circumstances, perform any testing or m

while it is being used to monitor a patient.• Verify that all visible indicators appear during the start-up (

indicator does not appear, do not use the WristOx. Contactfor assistance.

• This equipment complies with International Standard EN 6netic compatibility for medical electrical equipment and/ordesigned to provide reasonable protection against harmful iinstallation. However, because of the proliferation of radio-ment and other sources of electrical noise in healthcare andble that high levels of such interference due to close proximmight disrupt the performance of this device. Medical elect

talled and put into service l. fect medical electrical

leshooting” or discontinue use l.n replacing batteries. There are

operly.s regarding disposal or recy-

ries.her liquids.

e repaired by trained NONIN

erial oxygen saturation of func-globin may affect the accuracy

8

precautions regarding EMC, and all equipment must be insaccording to the EMC information specified in this manua

• Portable and mobile RF communications equipment can afequipment.

• If the WristOx fails to respond as described, refer to “Troubuntil the situation has been corrected by qualified personne

• Do not remove any covers other than the battery cover wheno user-serviceable parts inside.

• Batteries might leak or explode if used or disposed of impr• Follow local governing ordinances and recycling instruction

cling of the device and device components, including batte• Do not immerse the WristOx or sensors in water or any ot• Do not place or pour liquids on top of the WristOx.• The WristOx is a precision electronic instrument. It must b

personnel only.• The WristOx is designed to determine the percentage of art

tional hemoglobin. Significant levels of dysfunctional hemoof the measurement.

9

he likelihood of motion artifact stances, however, the WristOx

to determine the positioning of tient. Patient sensitivity varies

their concentrations, might

netic disturbances.ansmission and affect SpO2

ical and Electronic Equipment nsorted municipal waste. This butor regarding take-back or distributor, please call Nonin

• The WristOx has motion tolerant software that minimizes tbeing misinterpreted as good pulse quality. In some circummay still interpret motion as good pulse quality.

• Check the pulse oximeter sensor application site frequently the sensor and the circulation and skin sensitivity of the padepending on medical status or skin condition.

• Cardiogreen and other intravascular dyes, depending upon affect the accuracy of the SpO2 measurement.

• This device has not been tested for immunity to electromag• Some nail polish colors or artificial nails can reduce light tr

accuracy.• In compliance with the European Directive on Waste Electr

(WEEE) 2002/96/EC, do not dispose of this product as udevice contains WEEE materials; please contact your distrirecycling of the device. If you are unsure how to reach yourfor your distributor’s contact information.

the WristOx is damaged. ristOx:

10

Unpacking and Inspecting the WristOxContact the carrier immediately if the shipping carton for Confirm that the items listed below are packed with the W

• Model 3100 Wrist Oximeter• Two 1.5V Alkaline N-cell Batteries• WristOx Operator’s Manual• 8000AA-WO Fingerclip Sensor• 1 Reusable Wristband

11

, wrist-worn device indicated for ration of arterial hemoglobin

r data collection and recording of latory, subacute, and sleep study

equired!

eck mode, inserting a finger in the er turns off the WristOx automat-ailable with NONIN’s nVI-ed Features” to learn more about

Using the WristOxIndications for UseThe NONIN® Model 3100 WristOx® pulse oximeter is a smalluse in measuring, displaying, and storing functional oxygen satu(SpO2) and pulse rate. It may be used for spot-checking and/oadult and pediatric patients in hospitals, medical facilities, ambuenvironments.

WARNING! Do not use the WristOx when alarms are r

The WristOx comes packaged in Spot Check mode. In Spot Chsensor turns on the WristOx automatically, and removing a fingically. Advanced memory and programming features are only avSION® software (version 5.0 or greater). See “Accessing Advancusing the WristOx with nVISION software.

x, and carefully remove the battery

ng to local governing ordinances.sitioning is essential for proper operation. into place; it fits only when

to the unit, reinsert the batteries or

12

Installing the Batteries1. Use your thumb to loosen the lower front cover of the WristO

door by sliding it downward..

2. Remove the old batteries and discard or recycle them accordi3. Insert two new 1.5V alkaline N-cell batteries. Correct battery po4. Carefully re-position the battery door. Do not force the door

positioned properly.5. If the WristOx does not turn on when a sensor is plugged in

refer to “Troubleshooting.”

++

13

utes before entering critical s or records patient data. Replace

removing or replacing tOx memory. Stored datawer data or cleared fromr greater).

Important Notes about Battery UseThe Battery Indicator will begin to flash approximately 30 minbattery mode. In critical battery mode, the WristOx no longer monitorlow batteries as soon as possible.

NOTE: The WristOx contains non-volatile memory, sobatteries will not affect the data stored in Wriswill remain in memory until overwritten by nememory with nVISION software (version 5.0 o

he sensor, and begin taking

ugh the spring bars on the rear the top of the WristOx should

14

Setting Up the WristOx and Attaching the SensorUse the following procedure to thread the wrist strap, attach t%SpO2 readings. .

1. Begin threading the short segment of the wrist strap throof the WristOx. As illustrated above, the spring bar nearbe threaded first.

15

ly through both spring bars on

2. Continue threading the wrist strap until it is pulled securethe rear of the WristOx.

t the already-threaded strap. .

16

3. Press the long segment of the wrist strap securely againsThe WristOx is now securely mounted on the wrist strap

17

Ox, ensuring that all indicators

red triangle on the sensor

4. Plug the sensor into the connector at the top of the Wristappear during the first phase of the startup sequence.

NOTE: When the sensor is completely connected, theconnector should not be visible.

he patient’s wrist. espective sensor instructions ety.

er acts as the ON/OFF r more information about x.

18

5. Apply the wrist band securely and comfortably around t6. Place the patient’s finger inside the sensor. Refer to the r

for specific information about placement and patient saf

NOTE: In Spot Check mode (default), the patient fingswitch. See “Accessing Advanced Features” foother modes that are available with the WristO

19

ence and self-test when a sensor ase of the startup sequence. If NONIN Customer Support for

oval is not detected, thetes.

20

Verifying WristOx OperationThe WristOx performs an automatic startup (initialization) sequis plugged in. Verify that all indicators display during the first phany indicator is not displayed, do not use the WristOx. Contact assistance.

NOTE: If the device cannot track the pulse or finger remWristOx will shut off automatically after 3 minu

21

S%N display blood oxygen satura-t

PT of the WristOx (identified by t e rate in beats per minute.

es when a sensor has become lied correctly.

ystem FeaturesSpO2 Displayumeric indicators on the upper left-hand corner of the WristOx

ion in percent (indicated by the %SpO2 icon).

ulse Rate Displayhe pulse rate display is the lower numeric display on the left side

he symbol). This 3-digit indicator display shows the puls

Pulse Oximeter Sensor IndicatorThe Pulse Oximeter Sensor Indicator indicatdisconnected, has failed, or has not been app

trength as determined by the Bargraph is proportional to the

e. If there is a sustained series of e Pulse Quality Indicator will dis-

ritical, this Indicator blinks, pro- critical battery capacity is met, ped.

or pulse rate reading is com-.

22

Pulse Strength Bargraph Indicator This 10-segment bargraph indicates pulse soximeter. The height of the Pulse Strength pulse amplitude.

Pulse Quality IndicatorThis Indicator blinks to indicate a poor pulspoor pulses (approximately 10 seconds), thplay solid.

Battery IndicatorAny time the WristOx batteries are low or cviding early warning to replace them. Afterthe display turns off and monitoring is stop

Numeric IndicatorsNumeric Indicators appear after an %SpO2plete, providing results of the measurement

23

s for the WristOx, nVISION xible and convenient data man-d, transfer, analyze, report, and IN pulse oximeter models.

ich mode the device is in.

Accessing Advanced FeaturesTo access additional modes of operation and advanced featuresoftware (version 5.0 or greater) is required. nVISION is a fleagement and oximetry screening tool that allows users to recorarchive patient data. nVISION is compatible with many NON

NOTE: Data is stored in the WristOx regardless of wh

.0 or greater) to set various fea-y package, which includes nVI-

IN.

Ox with nVISION software:

, and parameters can be memory can be cleared; and

d time of the computer.ISION software. Partial Dis-

ight add to patient anxiety in e rate data are not displayed on

te

24

Using the WristOx with nVISION SoftwareThe WristOx can be used with nVISION® software (version 5tures and options according to user needs. A WristOx accessorSION software and a computer cable, is available from NON

The following advanced settings can be programmed in Wrist

In addition, information about device model number, revisionretrieved; patient data can be downloaded and stored; WristOxthe WristOx date and time can be synchronized to the date anFull and Partial Display modes are also programmable with nVplay mode can be used if visible %SpO2 and pulse rate data mlonger-term studies. In Partial Display mode, %SpO2 and pulsthe WristOx, but the Pulse Strength Bargraph is still visible.

• Date • Time• ID • Patient Data Storage Ra• Display Options • Activation Options

25

ode, and Programmed mode.

Spot Check mode, inserting a removing a finger turns OFF t attached (plugged in) to the

emoval is not detected, theutes.

are (version 5.0 or greater). In WristOx functions like an ON/or Activation mode, the invalid pulse detection.

r 30 minutes, the sensorer to turn on the WristOx.

Activation OptionsThe WristOx features Spot Check mode, Sensor Activation m

Spot Check ModeSpot Check mode is the WristOx default activation setting. In finger in the sensor turns ON the WristOx automatically, and the WristOx automatically. In this mode, the sensor can be lefWristOx.NOTE: If the device cannot track the pulse or finger r

WristOx will shut off automatically after 3 min

Sensor Activation ModeSensor Activation mode can be selected with nVISION softwthis mode, connecting and disconnecting the sensor from the OFF switch (whether or not a finger is in the sensor). In SensWristOx shuts off automatically after 30 minutes of no use or

NOTE: When the WristOx shuts off automatically aftemust be unplugged and then reattached in ord

fined intervals that are rammed mode allows users to be connected in order for Pro-

d off ONLY at pre-sed at unprogrammed times software.

26

Programmed ModeIn Programmed mode, the WristOx turns on and off at user-deselected using nVISION software (version 5.0 or greater). Progselect up to three start and stop times and dates. The sensor mustgrammed mode to function.

NOTE: In Programmed mode, the WristOx turns on anprogrammed intervals. The device cannot be uuntil exiting Programmed mode with nVISION

27

reater), a WristOx-compatible n be connected to a computer e the instructions below to

computer.

tOx is now ready for use with

refer to nVISION software’s

ecurely, the red triangle on

Connecting the WristOx to a ComputerTo use the WristOx with nVISION software (version 5.0 or gcomputer cable (Model 1000SC-WO) is needed. This cable cafor data downloading and editing with nVISION software. Usconnect the WristOx to a computer:1. Connect the cable to the appropriate COM port on the 2. Plug the cable to the top of the WristOx.3. Wait until CP appears in the WristOx display. The Wris

nVISION software. 4. For more information about capturing and saving data,

online help.

NOTE: When the cable is connected completely and sthe cable connector should not be visible.

pulse rate information with a 4-egins overwriting the oldest ata are automatically collected

te are stored.

e and date (if the clock is set of recording sessions. Patient r every one or two seconds if ). The oxygen saturation values

r, data storage capacity isate.

28

Memory FeaturesThe WristOx collects and stores up to 33 hours of SpO2 and second data storage rate. When the memory fills up, the unit bdata with the new data. Each time the WristOx is turned on, din memory.

NOTE: Only recording sessions longer than one minu

Each time the WristOx is turned on, the current oximeter timproperly) are stored in memory to allow quick differentiation SpO2 and pulse rate are stored every four seconds (default), oprogrammed using nVISION software (version 5.0 or greaterare stored in 1% increments in the range of 0 to 100%.

NOTE: Storage rates do not affect battery life; howevereduced when using a 1- or 2-second storage r

29

to approximately 16 hours. to approximately 8 hours.

. The stored values are in incre-pulses per minute, and in incre-ulses per minute.

ny data from memory.

Using a 2-second storage rate, data storage capacity is reducedUsing a 1-second storage rate, data storage capacity is reduced

The stored pulse rate ranges from 18 to 300 pulses per minutements of one pulse per minute in the interval from 18 to 200 ments of 2 pulses per minute in the interval from 201 to 300 p

NOTE: Playing back data in memory does not clear a

ot use caustic or abrasive

structions regarding cleaning .

cohol. Do not pour or spray any y openings in the device. Allow

s. See “Specifications” for addi-

30

Cleaning and Storing the WristOxNOTE: Do not immerse the WristOx in liquid, and do n

cleaning agents on the WristOx.

Clean the WristOx separately from its associated sensors. For inoximeter sensors, refer to the appropriate sensor package inserts

Clean the WristOx with a soft cloth dampened with isopropyl alliquids onto the WristOx, and do not allow any liquid to enter anthe WristOx to dry thoroughly before reusing.

Store the WristOx within the stated environmental specificationtional information.

31

inute

h

s

w nominal

w nominal

Specifications

OXIMETER SPECIFICATIONS

Oxygen Saturation Range (%SpO2) 0% to 100%Pulse Rate Range 18 to 300 pulses per mDisplays

Numeric Displays 3-digit IndicatorsPulse Indicator Pulse Strength Bargrap

AccuracyBlood Oxygen Saturation (%SpO2) (± 1 S.D.)a

70% to 100% ± 2 digit

Pulse Rate ± 3%Measurement Wavelengths and Output Power

Red 660 nanometers @ 3 mInfrared 910 nanometers @ 3 m

eres

+0° to +50°C)

0° to +50°C)

condensing

condensing

N-cell batteries

rs of continuous operation

32

AltitudeOperating Altitude Up to 40,000 feetHyperbaric Pressure Up to 4 atmosph

SYSTEM SPECIFICATIONS

TemperatureOperating +32° to +122°F (Storage/Transportation 14° to +122°F (-1

HumidityOperating 10% to 90% nonStorage/Transportation 10% to 95% non

Power Requirements Two 1.5V alkalineBattery Life

Operating minimum 24 hou

33

x 0.75 in D5 cm W x 1.905 cm D)

t batteries or wrist strapt batteries or wrist strap)

. data storage rate; 16 hours @ s @ 1 sec. rate

601.1; UL60601-1 30EM

d (on battery power)

Part

readings may fall outside these limits.

Storage 9 monthsDimensions (without sensor or strap) 2 in H x 1.75 in W

(5.08 cm H x 4.44Weight ~0.88 oz. withou

(~24.95 g withouMemory

Type NonvolatileCapacity 33 hours @ 4 sec

2 sec. rate; 8 hour

CLASSIFICATIONS PER IEC 60601-1; CAN/CSA C22.2 NO.Type of Protection Internally powereDegree of Protection Type BF-AppliedMode of Operation Continuous

a. S.D. (Standard Deviation) is a statistical measure; up to 32% of the

ct your distributor, or contact

ws® 95/98/00/NT

aterial)ists (elastic VELCRO® material)

34

Parts and Accessories

For more information about NONIN parts and accessories, contaNONIN at (800) 356-8874 (USA and Canada) or (763) 553-9968.

3100CC WristOx Carrying Case3100 Manual Operator’s Manual for the WristOx1000SC-WO Computer cable

Pulse Oximeter Reusable Sensors8000AA-WO Adult Articulated Finger Clip Sensor 8000J-WO Adult Flex Sensor

Other AccessoriesnVISION nVISION® software (5.0 or greater) for Windo8000JFW Adult FlexiWrap Sensor Wrap3100WB 10” Reusable Wrist Band (elastic VELCRO® m3100WBE 5” Reusable Wrist Band Extender for Larger Wr

35

ations from internal software ts to drift, and no calibration of

ct your local sales representative r area, contact NONIN at (800) turning any product to NONIN. Customer Support Department

E-mail: mail@nonin.com ada) Website: www.nonin.com

Service and SupportThe Model 3100 Wrist Oximeter module performs all computstored in microprocessor chips. Thus, there are no critical parthe pulse oximeter module is required.

For information about the Model 3100 and accessories, contaor distributor. For the sales representative or distributor in you356-8874. A return authorization number is required before reTo obtain this return authorization number, contact NONIN’sat:

Nonin Medical, Inc. Phone: 763-553-996813700 1st Avenue North 800-356-8874 (USA and CanPlymouth, MN 55441-5443 USA Fax: 763-553-7807

the purchaser the pulse oximetry se. NONIN shall repair or this warranty, free of charge, for er that there is a defect, provided s warranty shall be the sole and delivered to the purchaser that is contract, tort, or by law.

epaired units shall be received by fee for a warranty repair request precision electronic instrument IN personnel only. Accordingly, on-NONIN personnel, tamper-y. All non-warranty work shall be the time of delivery to NONIN.

es of any kind, whether statutory,

36

WarrantyNONIN MEDICAL, INCORPORATED, (NONIN) warrants tomodule of the Model 3100 for three years from the date of purchareplace any Model 3100 found to be defective in accordance with which NONIN has been notified by the purchaser by serial numbsaid notification occurs within the applicable warranty period. Thiexclusive remedy by the purchaser hereunder for any Model 3100 found to be defective in any manner, whether such remedies be in

This warranty excludes cost of delivery to and from NONIN. All rthe purchaser at NONIN. NONIN reserves the right to charge a on any unit found to be within specifications. The Model 3100 is aand must be repaired by knowledgeable and specially trained NONany sign or evidence of opening the Model 3100, field service by ning, or any kind of misuse of the Model 3100 shall void the warrantdone according to NONIN standard rates and charges in effect at

DISCLAIMER/EXCLUSIVITY OF WARRANTY:The warranties in this manual are exclusive, and no other warrantiwritten, oral, or implied, shall apply.

37

ible Solution

k batteries.

ace batteries and try again.

onnect sensor and try again.

VISION software to reset tOx in Spot Check or Sensor ation mode.

VISION software to reset tOx in Full Display mode.

Troubleshooting

Problem Possible Cause Poss

Device won’t activate. Batteries inserted wrong. Chec

Batteries are depleted. Repl

Sensor is disconnected. Re-c

WristOx set in Programmed mode.

Use nWrisActiv

No %SpO2 or pulse rate display.

WristOx set in Partial Dis-play mode.

Use nWris

sition or replace finger; keep r motionless.

ove and re-connect sensor. r to sensor instructions to apply r correctly.sition or replace finger; keep r motionless. application site.

sition or replace finger; keep r motionless.

ible Solution

38

No pulse display on bargraph.

Low patient pulse strength. ReposensoRem

Sensor applied incorrectly. Refesenso

Poorly perfused finger. ReposensoWarm

Finger positioned wrong. Reposenso

Problem Possible Cause Poss

39

ce or eliminate interference.

hand to rest without squeez-r pressing sensor.

d sensor from light source.

y sensor to finger without fin-il polish or an artificial nail.

ible Solution

No pulse display on bargraph, cont’d.

Possible interference from:• arterial catheter• blood pressure cuff• electrosurgical procedure• infusion line

Redu

Reduced circulation from excess pressure on sensor.

Allowing o

Excessive ambient light. Shiel

Sensor applied to polished or artificial nail.

Applgerna

Problem Possible Cause Poss

the finger.

the finger and inside of sensor.

ONIN Customer Support.

ce patient motion.

sition or replace finger; keep r motionless. the application site.

NONIN Customer Support.

ible Solution

40

No pulse display on bargraph, cont’d.

Finger is cold. Warm

Finger is wet. Dry

Indicator not lit in finger insertion area.

Call N

Excessive patient motion. Redu

Pulse Oximeter Sen-sor indicator appears.

Poor signal detected from finger.

ReposensoWarm

The WristOx needs repair. Call

Problem Possible Cause Poss

41

ONIN Customer Support at

VISION software to set start top times correctly.

VISION software to set date ime correctly.

ible Solution

If these solutions do not correct the problem, please contact N(800) 356-8874 (USA and Canada) or (763) 553-9968.

WristOx doesn’t record in Pro-grammed mode.

Start and stop times set inconsistently.

Use nand s

WristOx date and time set-tings are incorrect (or lost after removing batteries).

Use nand t

Problem Possible Cause Poss

vice’s compliance to IEC Standard

nvironment—Guidance

d below. The customer and/or user

energy only for its internal function. issions are very low and are not terference in nearby electronic

le for use in all establishments, and those directly connected to the ower supply network that supplies omestic purposes.

42

Manufacturer’s DeclarationRefer to the following table for specific information regarding this de60601-1-2.

Table 1: Electromagnetic Emissions

4950-001-03

Emissions Test Compliance Electromagnetic E

This device is intended for use in the electromagnetic environment specifieof this device should ensure that it is used in such an environment.RF EmissionsCISPR 11

Group 1 This device uses RFTherefore, its RF emlikely to cause any inequipment.

RF EmissionsCISPR 11

Class B This device is suitabincluding domestic public low-voltage pbuildings used for dHarmonic Emissions

IEC 61000-3-2N/A

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

N/A