SPECTRO2 30 WW1030 Operation Manual Ver 1 Sept 2009

Table of Contents

Table of Contents Warranty and Service Information...vii Proprietary Notice... vii Warranty... vii Limited Warranty... vii Disclaimer of Warranties... vii Conditions of Warranty... vii Limitation of Remedies... vii Warranty Procedure...viii CE Notice...viii

Chapter 1: Introduction... 1-1 About the Manual... 1-1 Definition of Symbols... 1-1 Warnings... 1-3 Cautions... 1-7 Notes... 1-8

Chapter 2: Intended Use and Monitor Features... 2-1 Intended Use... 2-1 Monitor Features... 2-1 Theory of Operation... 2-2 Pulse Amplitude Index... 2-3 Patented Technology... 2-3

Chapter 3: Controls and Features... 3-1 Monitor Front View ... 3-1 Front Display... 3-2 Monitor Operating Keys... 3-3 Monitor Back and Bottom Panels... 3-4

Chapter 4: Operating Instructions... 4-1 Unpacking the Monitor... 4-1 Powering the Oximeter... 4-1 Installing the Batteries... 4-3 External Power ... 4-4 AC Power... 4-5 USB Power (Universal Serial Bus)... 4-6 Turning On the Monitor... 4-7 Checking the Monitor’s Performance... 4-8 Attaching the Sensor to the Patient... 4-9 Choosing the Sensor...4-10 BCI® Sensors...4-10 Nellcor® Sensor...4-10 Clinician’s Operation Manual

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Table of Contents Cleaning or Disinfecting the Sensors...4-11 Checking the Sensor and Oximetry Cable...4-11 Pulse Amplitude Index...4-12 Storing the Sensor...4-14

Chapter 5: Changing the Monitor’s Settings... 5-1 Changing the Pulse Beep Volume... 5-1 Setup Menu... 5-1 SpO2 and Pulse Rate Averaging... 5-2 High Sensitivity Mode... 5-3 Display Brightness... 5-3 Clock/ Calendar... 5-4 Year, Month, Day... 5-4 Hours, Minutes... 5-5 Restore Alarm Defaults... 5-6 Clinician Menu... 5-7 Device Mode... 5-7 Trend Interval... 5-8 Language... 5-8 Remote Alarm Active... 5-9 Factory Defaults... 5-9

Chapter 6: Alarms... 6-1 Alarm Priorities... 6-1 Silencing Alarm Tones ... 6-2 High Priority Alarms... 6-3 Medium Priority Alarms... 6-4 Low Battery... 6-4 Remote Alarm Cable Fault... 6-4 Low Priority Alarms... 6-5 Alarm Summary... 6-5 Alarm Menu... 6-6 Changing the Alarm Limits... 6-6 Alarm Volume... 6-7 Restoring Default Alarm Limits... 6-7

Chapter 7: Remote Alarms... 7-1 Setup... 7-1 Turning On or Off Remote Alarms... 7-2 Inhibiting the Remote Alarm Signal... 7-2

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Chapter 8: Patient Record Number and Trend Data... 8-1 Description... 8-1 Incrementing the Patient Record Number . ... 8-1 Memory Capacity... 8-1 Adjusting the Trend Storage Interval... 8-1 Clearing Trend Data... 8-2 Trend Data Output... 8-2

Chapter 9: Optional Docking Station and Printer... 9-1 Description... 9-1 Docking Station... 9-2 Powering the Docking Station... 9-2 WW1090 Lithium-Ion (Li+) Rechargeable Battery Pack... 9-3 Installing the Oximeter to the Dock... 9-3 Downloading Data to PC... 9-4 Printer... 9-4 Attaching the Printer... 9-5 Loading Paper... 9-6 Choosing the Print Mode . ... 9-7 Trend Data Condition Flags... 9-8

Chapter 10: PC Communication Setup... 10-1 Description...10-1 Power Input and Data Connector Port ...10-2 How to Set Up Equipment...10-3 Sensor / RS232 Port...10-4 How to Set Up Equipment...10-4 Output Format...10-5

Chapter 11: Operating Modes... 11-1 About the Monitor’s Operating Modes...11-1 Clinician Mode...11-1 Home Mode...11-1 Setting Up the Monitor for Home Use...11-2 Turning off the monitor in Home Mode...11-2 Equipment and Supplies Checklist for Home Use...11-3 Training the Home Use Caregiver...11-4 Exiting Home Mode...11-5 Sleep Mode...11-6 Setting Up the Monitor for Sleep Screening...11-6 Exiting Sleep Mode...11-6

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Chapter 12: Maintenance... 12-1 Routine Maintenance...12-1 Cleaning and Disinfecting...12-1 Storage...12-2

Chapter 13: Troubleshooting... 13-1 Correcting an Alert Condition...13-1 Power...13-2 Sensor...13-3 Printer and Data Communication...13-4 Other...13-5

Chapter 14: Optional Supplies and Accessories... 14-1 Ordering Information...14-2

Chapter 15: Specifications... 15-1 Displays...15-1 Indicators...15-1 Keys/User Controls...15-1 SpO2. ...15-2 Pulse Rate...15-3 Pulse Amplitude Index...15-4 Printer...15-4 Serial Data Output...15-4 Power Input and Data Connector ...15-4 Sensor Connector...15-4 Power Requirements...15-5 Battery...15-5 AC Charger...15-5 USB...15-5 Monitor Dimensions...15-5 Dock Dimensions...15-5 Auxiliary Inputs/Outputs...15-5 Environmental...15-6 Equipment Classification...15-6 Design Standards...15-6

Appendix A: Guidance and Manufacturer’s Declaration...A-1 Guidance and Manufacturer’s Declaration...A-1 Electromagnetic Emissions - Emissions Test...A-1 Electromagnetic Immunity - Immunity Test...A-2 Recommended Separation Distances...A-4

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Clinician’s Operation Manual

Table of Contents The serial autocorrelation technology (SAC) in the monitor is covered by U.S. Patent No. 5,558,096. BCI, Comfort Clip, SPECTRO2 and the Smiths design mark are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.

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Clinician’s Operation Manual

Warranty and Service Information

Warranty and Service Information Proprietary Notice Information contained in this document is copyrighted by Smiths Medical PM, Inc. and may not be duplicated in full or part by any person without prior written approval of Smiths Medical PM, Inc. Its purpose is to provide the user with adequately detailed documentation to efficiently install, operate, maintain, and order spare parts for the device supplied. All information contained in this document is believed to be current and accurate as of the date of publication or revision, but does not constitute a warranty.

Warranty Limited Warranty Smiths Medical PM, Inc. (“Seller”) warrants to the original purchaser that the Product, not including accessories, shall be free from defects in material and workmanship under normal use, if used in accordance with its labeling, for three years from the date of shipment to the original purchaser. Seller warrants to the original purchaser that the reusable oximeter sensors supplied as accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with its labeling, for one year from the date of shipment to the original purchaser (USA only).

Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY, AS CONDITIONED AND LIMITED, IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Seller disclaims responsibility of the suitability of the Product for any particular medical treatment or for any medical complications resulting from the use of the Product. This disclaimer is dictated by the many elements which are beyond Seller’s control, such as diagnosis of patient, conditions under which the Product may be used, handling of the Product after it leaves Seller’s possession, execution of recommended instructions for use and others.

Conditions of Warranty This warranty is void if the Product has been altered, misused, damaged by neglect or accident, not properly maintained or recharged, or repaired by persons not authorized by Seller. Misuse includes, but is not limited to, use not in compliance with the labeling or use with accessories not manufactured by Seller. This warranty does not cover normal wear and tear and maintenance items.

Limitation of Remedies The original purchaser’s exclusive remedy shall be, at Seller’s sole option, the repair or replacement of the Product. THIS IS THE EXCLUSIVE REMEDY. In no event will Seller’s liability arising out of any cause whatsoever (whether such cause is based on contract, negligence, strict liability, tort or otherwise) exceed the price of the Product and in no event shall Seller be responsible for consequential, incidental, or special damages of any kind or nature whatsoever, including but not limited to, lost business, revenues, and profits. Clinician’s Operation Manual

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Warranty and Service Information

Warranty Procedure To obtain warranty service in the USA, you must request a Return Authorization (RA) number from Technical Service. Reference the RA number when returning your Product, freight and insurance prepaid, to: Smiths Medical PM, Inc. N7W22025 Johnson Drive Waukesha, WI 53186-1856

Phone: (262) 542-3100 Fax: (262) 542-0718 Toll Free: (800) 558-2345

Seller will not be responsible for unauthorized returns or for loss or damage to the Product during the return shipment. The repaired or replaced Product will be shipped, freight prepaid, to Purchaser. To obtain warranty information outside of the USA, contact your local distributor. Keep all original packing material, including any inserts. If you need to ship the device, use only the original packaging material, including inserts. Box and inserts should be in original condition. If original shipping material in good condition is not available, it should be purchased from Smiths Medical PM, Inc. Damages occurring in transit in other than original shipping containers are the responsibility of the shipper. All costs incurred returning devices for repair are the responsibility of the shipper.

CE Notice Marking by the symbol 93/42/EEC.

2 indicates compliance of this device to the Medical Device Directive

@ Authorized Representative (as defined by the Medical Device Directive): Smiths Medical International Ltd. Colonial Way, Watford, Hertfordshire, WD24 4LG, UK

Phone: (44) 1923 246434 Fax: (44) 1923 240273

Australian Representative: Smiths Medical Australasia Pty. Ltd. 61 Brandl Street, Eight Mile Plains, QLD 4113, Australia

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Tel: +61 (0) 7 3340 1300

Clinician’s Operation Manual

Chapter 1: Introduction

Chapter 1: Introduction About the Manual The Clinician’s Operation Manual provides installation, operation, and maintenance instructions for the health-care professional trained in monitoring respiratory and cardiovascular activity. The Home-Use Instruction Book provides operation and maintenance instructions for the in home caregiver. The caregiver is assumed to be trained in oximeter use by a doctor or other healthcare professional. The Home-Use Instruction Book supplements, and does not replace, training provided by a health-care professional in oximeter use. These instructions contain important information for safe use of the product. Read the entire contents of these Instructions For Use, including Warnings and Cautions, before using the monitor. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient.

Definition of Symbols symbol

6

definition Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

R

Type BF Equipment

f

Attention, see instructions for use.

7

Refer servicing to qualified service personnel.

%SpO2

Percent Oxygen Saturation

p

Pulse Rate (beats per minute)

PI

Pulse Amplitude Index Battery Charge Indicator External Power Indicator

B

Alarm SILENCE (Key and Indicator)

x

On/Off Key Menu/Enter Key Exit Key

no

Up and Down Arrow Keys

1

Printer LED - Real Time Printout

2

Printer LED - Numeric Trend Tables

3

Printer LED - Graphic Trend Printer LED - Error Printer Key - Select Print Printer Key - Start / Stop Print Docking Station LED - AC Power

Clinician’s Operation Manual

1-1

Chapter 1: Introduction symbol

definition Docking Station LED - USB Power Docking Station LED - Charging Spare Battery Printer icon: Parameter Alarm Printer icon: Artifact Printer icon: Small Pulse Printer icon: Check Sensor Printer icon: Searching too Long Printer icon: Lost Pulse

7

Do not reuse. One use on one patient.

K 1

Moisture Sensitive

D

Output Voltage Connector

E G 0

Input Voltage Connector

IPX2

Drip proof (monitor and dock only)

<

Catalog Number

J

Date of Manufacture

@

Z

Collect Separately

Y

Not suitable for use in the presence of a flammable anesthetic mixture.

Direct Current Speaker

Authorized Representative in the European Community Disposal (EU Countries) Under the Waste Electrical and Electronic Equipment (WEEE) Directive 2006/96/EC and implementing regulations, all devices and service items within the scope of the Directive purchased new after August 13, 2005 must be sent for recycling when ultimately becoming waste. Devices and items must not be disposed of with general waste. If purchased before that date, they may also be sent for recycling if being replaced on a one-for-one, like-for-like basis (this varies depending on the country). Recycling instructions to customers using Smiths Medical products are published on the internet at: http://www.smiths-medical.com/recycle Disposal (other countries) When disposing of this device, its batteries or any of its accessories, ensure that any negative impact on the environment is minimized. Contact your local waste disposal service and use local recycling or disposal schemes. Separate any other parts of the equipment where arrangements can be made for their recovery; either by recycling or energy recovery. The main batteries are potentially harmful and will require separate disposal according to manufacturer’s instructions or local regulations. Note: If applicable, EU, national or local regulations concerning waste disposal must take precedence over the above advice.

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Clinician’s Operation Manual

Chapter 1: Introduction keyword

definition

WARNING

Something that could hurt the patient or hurt the operator.

CAUTION

Something that could damage the monitor.

NOTE

Other important information.

Warnings WARNING! The monitor was not designed or tested to be an apnea monitor. WARNING! Do not use this device in the presence of flammable anesthetics. WARNING! Do not use this device in the presence of magnetic resonance imaging (MR or MRI) equipment. Warning! Operation of this device may be adversely affected in the presence of conducted transients or strong electromagnetic (EM) or radiofrequency (RF) sources, such as portable and mobile RF communication equipment, electrosurgery and electrocautery equipment, x-rays, and high intensity infrared radiation. Warning! Operation of this device may be adversely affected in the presence of computed tomograph (CT) equipment. WARNING! Any monitor that has been dropped or damaged should be inspected by qualified service personnel, prior to use, to insure proper operation. Warning! If the accuracy of any measurement is in question, verify the patient’s vital signs by an alternative method, and then check the monitor for proper functioning. WARNING! This device must be used in conjunction with clinical signs and symptoms. This device is only intended to be an adjunct in patient assessment. WARNING! This device is intended for use by persons trained in professional health care or those who have access to the oversight of a professional health care provider. The operator must be thoroughly familiar with the information in this manual before using the device. Warning! It is the operator’s responsibility to set alarm limits appropriately for each individual patient. WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. WARNING! When attaching sensors with Microfoam® tape, do not stretch the tape or attach the tape too tightly. Tape applied too tightly may cause inaccurate readings and blisters on the patient’s skin (lack of skin respiration, not heat, causes the blisters). WARNING! Verify the functionality of any remote alarm system connected to this monitor before leaving the patient unattended. Clinician’s Operation Manual

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Chapter 1: Introduction WARNING! The remote alarm feature should not be used as the primary source of alarm notification. The audible and visual alarms of the monitor, used in conjunction with clinical signs and symptoms, are the primary sources for notifying medical personnel that an alarm condition exists. Warning! Use only SpO2 sensors supplied with, or specifically intended for use with, this device. WARNING! Incorrectly applied sensors may give inaccurate readings. f Refer to the sensor insert for proper application instructions. WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid. This may cause damage to the sensor which may cause inaccurate readings. WARNING! Unplug the sensor from the oximeter before cleaning or disinfecting to prevent damaging the sensor or monitor, and to prevent user safety hazards. WARNING! Measurements made at sites with low perfusion are potentially inaccurate. Always use measurements in conjunction with other clinical signs and symptoms. Warning! SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, for example) if necessary. Warning! Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, fluorescein, and patent blue V (PBV) may adversely affect the accuracy of the SpO2 reading. Warning! Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings. Warning! Optical cross-talk can occur when two or more sensors are placed in close proximity. It can be eliminated by covering each site with an opaque material. Warning! Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. Warning! Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin (with CO-poisoning) or methemoglobin (with sulfonamide therapy), will affect the accuracy of the SpO2 measurement. WARNING! Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin, porfimer sodium, and metatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at least every hour and observe for signs of tissue damage. More frequent sensor site changes/inspections may be indicated depending upon the photodynamic agent used, agent dose, skin condition, total exposure time or other factors. Use multiple sensor sites.

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Clinician’s Operation Manual

Chapter 1: Introduction WARNING! When connecting this monitor to any instrument, verify proper operation before clinical use. Refer to the instrument’s user manual for full instructions. Accessory equipment connected to the monitor’s data interface must be certified according to the respective IEC standards, i.e., IEC 60950 for data processing equipment or IEC 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC 60601-1-1 systems requirements. Anyone connecting additional equipment to the signal input port or the signal output port configures a medical system, and therefore is responsible that the system complies with the requirements of the system standard IEC 60601-1-1. WARNING! IEC 60950 approved equipment must be placed outside the “patient environment.” The patient environment is defined as an area 1.5 m (4.92 feet) from the patient. Figure 1-1: Patient Environment 9f

.5

R1

m

(4.

t.)

WARNING! The oximeter will not operate without batteries installed. Properly charged batteries provide a reserve source of power in case of external power failure. Never use an oximeter with discharged batteries to monitor a patient. WARNING! Inspect battery terminals for corrosion or contamination. The monitor may not operate properly or could fail to alarm if battery terminals are corroded or contaminated. Do not use until battery terminals have been properly cleaned and repaired. WARNING! Check expiration date of batteries. The monitor may not operate properly or could fail to alarm if expired batteries are used. Do not use until proper batteries can be obtained. WARNING! Remove device batteries prior to long term storage. WARNING! Do not allow the patient to handle the device if the battery door has been removed, except while installing new batteries. WARNING! Disconnect the external power supply from the monitor or Docking Station before disinfecting or cleaning the monitor. WARNING! Do not plug the monitor or Docking Station into an outlet controlled by a wall switch. WARNING! Disconnect the AC power supply from the outlet before disconnecting it from the monitor. Leaving the AC power supply connected to an AC power outlet without being connected to the monitor may result in a safety hazard.

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Chapter 1: Introduction WARNING! Do not allow any moisture to contact the AC power supply connectors, or a safety hazard may result. Ensure that hands are thoroughly dry before handling the AC power supply. WARNING! Do not place the monitor or Docking Station in the patient’s bed or crib. Do not place the monitor or Docking Station on the floor. WARNING! Failure to place the monitor or Docking Station away from the patient may allow the patient to turn off, reset, or damage the monitor, possibly resulting in the patient not being monitored. Make sure the patient cannot reach the monitor from their bed or crib. WARNING! Failure to carefully route the cable from the sensor to the monitor may allow the patient to become entangled in the cable, possibly resulting in patient strangulation. Route the cable in a way that will prevent the patient from becoming entangled in the cable. If necessary, use tape to secure the cable. WARNING! If there is a risk of the AC power supply becoming disconnected from the monitor during use, secure the cord to the monitor several inches from the connection. WARNING! Ensure the device’s AC rating is correct for the AC voltage at your installation site before using this monitor. The monitor’s AC rating is shown on the external power supply. If the rating is not correct, do not use the monitor. Contact the Smiths Medical PM, Inc. service department, or your authorized service representative, for help. WARNING! Use only the power supply included with your monitor, or approved by Smiths Medical PM, Inc. Use of an inappropriate power supply may cause a patient shock hazard or cause the oximeter to stop monitoring. See Chapter 14: Optional Supplies & Accessories, for additional specific information. WARNING! The Docking Station must have a Printer or Printer Port Cover installed. Failure to do so may cause a risk of electrical shock to the patient or operator or risk damage to the equipment. WARNING! Under certain clinical conditions, pulse oximeters may display dashes if unable to display SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury. WARNING! Verify that all LEDs (light emitting diodes) on the display light up upon startup of the device. WARNING! Verify that the monitor sounds a short tone upon startup of the device. If no tone is heard, the speaker may be damaged. Do not use to monitor patients until the monitor has been repaired. See Turning on the Monitor in Chapter 4: Operating Instructions.

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Clinician’s Operation Manual

Chapter 1: Introduction

Cautions CAUTION! Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. CAUTION! 7 Do not disassemble unit, not user serviceable. Refer to qualified service personnel. CAUTION! Failure to charge the monitor while the monitor is in long term storage may shorten the battery life. Charge the monitor while it is in storage to ensure the longest battery life. CAUTION! Due to limitations of the Li-Ion chemistry, the rechargeable battery pack should not be charged at ambient temperatures above 45 °C (113 °F) or below 5 °C (41 °F). CAUTION! The WW1090 rechargeable battery pack is shipped with only 30% of full charge. The battery pack must be charged completely before use. CAUTION! The WW1090 rechargeable battery pack utilizes Li-Ion secondary cells. Dispose of spent batteries in compliance with your institution’s guidelines and local ordinances. CAUTION! Observe proper battery polarity (direction) when replacing batteries. CAUTION! Do not allow water or any other liquid to spill onto the monitor or Docking Station. Do not autoclave, ethylene oxide sterilize, or immerse the monitor or Docking Station in liquid. Evidence that liquid has been allowed to enter the monitor or Docking Station voids the warranty. CAUTION! Where the equipment has accidentally gotten wet, it should be wiped dry externally and allowed to dry thoroughly before use. CAUTION! Before cleaning or disinfecting the printer, unplug the AC adapter, remove the batteries and remove the paper. CAUTION! Do not allow printer paper to become wet. If the printer paper gets wet, remove the paper immediately. Do not use the printer until the paper is replaced. Caution! Chemicals used in some cleaning agents may cause brittleness of plastic parts. Follow cleaning instructions in this manual. CAUTION! Cleaning with disinfectants, including alcohol, may shorten the life of the plastic or electronic parts, but appropriate disinfection must still be performed. CAUTION! Pressing any key with sharp or pointed instruments may permanently damage the keypad. Only press keys with your finger.

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Chapter 1: Introduction

Notes NOTE: The WW1090 rechargeable battery pack utilizes circuitry that optimizes the charging of the batteries. New packs will require multiple charge / discharge learning cycles before optimum performance is obtained. NOTE: If the remote alarm is enabled and a low battery condition is present, the remote alarm will be activated. NOTE: Alarms may be tested while the monitor is in use by setting alarm limits such that the measured parameter is outside alarm limits. Return limits to the required settings after testing. NOTE: “SpO2 averaging” means the number of pulse beats over which the SpO2 value is averaged; “pulse averaging” means the number of seconds over which the pulse value is averaged. NOTE: Increasing or decreasing the averaging setting has no effect on the data update rate. NOTE: Alarm limits are retained through power cycles, with the exception of the following note. NOTE: If the low SpO2 limit is set to less than 85% it will be reset to 85% when the monitor is next powered on. The high SpO2 limit will be adjusted to 86% if it is 85% or less. NOTE: If the alarm volume is set to a value less then 8 at power down, it will be reset to 8 when the monitor is next powered on. NOTE: A Patient Simulator does not calibrate the monitor. The monitor does not require calibration. A Patient Simulator provides a known SpO2 and pulse rate to the monitor that allows the monitor’s performance to be checked. NOTE: A Patient Simulator cannot be used to assess the accuracy of a pulse oximeter and/ or sensor.

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Clinician’s Operation Manual

Chapter 2: Intended Use and Monitor Features

Chapter 2: Intended Use and Monitor Features Intended Use The WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient’s functional oxygen saturation (%SpO2), pulse rate ( p ), pulse signal strength, and Pulse amplitude Index (PI) readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW1030 may be used in the hospital or clinical environment, during emergency land transport and in the home. WARNING! The monitor was not designed or tested to be an apnea monitor.

Monitor Features • Provides fast, reliable SpO2, pulse rate, and pulse signal strength measurements on any patient, from neonate to adult. • Maintains accurate readings during periods of patient motion and when monitoring patients with low perfusion. • Ideally suited for use in hospitals, outpatient clinics, emergency rooms, during emergency land transport, in sleep labs, or in-home use. • Portable and lightweight. Weighs only 330 grams (12 ounces) with 4 “AA” batteries. • On-board sensor storage cradle holds the finger sensor when not in use. • Power options include four (4) standard “AA” (type IEC LR6) alkaline batteries, a rechargeable Lithium Ion battery pack, USB power, or an AC power adapter. • Rechargeable battery life is approximately thirty (30) hours (new battery). • An easy to read battery gauge indicates the charge level and provides a low battery alert. • Large, bright, easy-to-read LED display indicates SpO2 and pulse rate measurements. • 2 Nine-segment LED bar graphs indicate pulse signal strength and Pulse amplitude Index. • An audible “beep” sounds with each pulse beat. The volume can be adjusted or turned off. The pitch of the pulse “beep” corresponds to SpO2 value. • The alarm indicator on top of the oximeter lights up to communicate patient alarm information. • SpO2 and pulse rate averaging settings are user-selectable. • User-adjustable trend storage rate, ranging from 2 to 30 seconds per sample, provides flexibility for many applications. • Optional docking station transforms the device into a table top pulse oximeter, and can also be used to recharge the monitor’s lithium Ion battery pack, and a spare battery pack. • Optional printer allows for printing of trend information or real time data logs. • Optional remote alarm cable interfaces the monitor’s alarm output signal to the remote alarm (nurse call) system. Clinician’s Operation Manual

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Chapter 2: Intended Use and Monitor Features

Theory of Operation The pulse oximeter determines %SpO2 and pulse rate by passing two wavelengths of low intensity light, one red and one infrared, through body tissue to a photodetector. Information about wavelength range can be especially useful to clinicians. Wavelength information for this device can be found in the SpO2 Specifications section of this manual. Pulse identification is accomplished by using plethysmographic techniques, and oxygen saturation measurements are determined using spectrophotometric oximetry principles. During measurement, the signal strength resulting from each light source depends on the color and thickness of the body tissue, the sensor placement, the intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying effects of the pulse) in the body tissues. 1

2 Figure 2-1: Theory of Operation

1

Low intensity Red and Infrared LED light sources

2

Detector

The oximeter processes these signals, separating the time invariant parameters (tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters (arterial volume and SpO2) to identify the pulses and calculate functional oxygen saturation. Oxygen saturation calculations can be performed because blood saturated with oxygen predictably absorbs less red light than oxygen-depleted blood. WARNING! Since measurement of SpO2 depends on a pulsating vascular bed, any condition that restricts blood flow, such as the use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate SpO2 and pulse rate readings. WARNING! Under certain clinical conditions, pulse oximeters may display dashes if unable to display SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury.

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Chapter 2: Intended Use and Monitor Features

Pulse Amplitude Index The PI value is a relative measure of pulse-signal strength over time at a pulse oximeter monitoring site, and is non-pulsatile in nature. Pulse amplitude Index is defined as PI = (100 × AC)/DC where AC is the alternating current (pulsatile component of the signal) and DC is direct current (non-pulsatile component of the signal). For more information, see Pulse Amplitude Index in Chapter 4: Operating Instructions. NOTe! The PI value is a relative value that varies from patient to patient.

Patented Technology This oximeter incorporates patented technology and noise reducing hardware to enhance the oximeter’s ability to detect pulse amplitude in patients with poor peripheral perfusion. Blood Pulse Detection Method Using Serial Autocorrelation (SAC), patent number 5,558,096, analyzes a digitized signal, in real time, and compares it with previous pulse data. If similar characteristics to previous data are recognized, the device confirms a valid pulse. In essence, an individual’s pulse data is retained and used as a template to accept or reject future pulse signals. Patented technology, digital signal processing, and a greatly improved signal to noise ratio, provide for improved performance.

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