OXY 100 Operating Instructions Ver 5 Jan 2006

DISCLAIMER CARDIAC SCIENCE CORPORATION MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE CONTENTS OR USE OF THIS MANUAL, OR WITH RESPECT TO ANY CARDIAC SCIENCE CORPORATION. HARDWARE OR SOFTWARE, AND EXPRESSLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Copyright 2003 Cardiac Science Corporation All rights reserved. Printed in the United States of America No part of this publication may be reproduced, photocopied or transmitted without the express written consent of the publisher. Cardiac Science Corporation 500 Burdick Parkway Deerfield, Wisconsin 53531 U.S.A. (800) 777-1777

(608) 764-1919

Manufactured by: Smiths Medical PM, Inc. N7W22025 Johnson Drive Waukesha, WI 53186, USA Phone: (262) 542-3100 Fax: (262) 542-0718

Authorized Representative: Smiths Medical International Ltd Colonial Way, Watford, Herts UK, WD24 4LG Phone: (44) 1923 246434 Fax: (44) 1923 240273

The Burdick® OXY 100 is manufactured by Smiths Medical PM, Inc., Waukesha, WI, for Cardiac Science Corporation, Deerfield, WI. The symbol ® indicates the trademark is registered in the U.S. Patent & Trademark Office & certain other countries.

Table of Contents

Clinician’s Operation Manual Proprietary Notice ... iii WARRANTY ... iii Limited Warranty ... iii Disclaimer of Warranties ... iii Conditions of Warranty... iii Limitation of Remedies ... iii Warranty Procedure ... iv CE Notice... iv

Warnings, Cautions, & Notes

v

Symbol Definitions ... v Warnings ... v Cautions ... vi Notes ... vii

Chapter 1: Introduction

1

About the Manual... 1 Theory of Operation... 1

Chapter 2: Intended Use and Features

1

Intended Use ... 1 Features ... 1

Chapter 3: Monitor Assembly

1

Unpack the Monitor ... 1 Install the Batteries... 1

Chapter 4: The Monitor

1

Turn On/Off the Monitor ... 1 Monitor Automatic Power Down... 1 Check the Monitor’s Performance ... 2

Chapter 5: Monitor Display and Keypad

1

Monitor Display ... 1 Monitor Keypad ... 2 Enable/Disable the Pulse Beep... 2 Low Battery Indicator ... 2

Chapter 6: The Finger Sensor

1

Connect the Finger Sensor to the Monitor ... 1 Clean or Disinfect the Finger Sensor ... 2 Check the Integrity of the Finger Sensor ... 2

Chapter 7: Attach the Finger Sensor to the Patient

1

Finger Sensor Table ... 1

Chapter 8: Trend Data

1

Trend Data ... 1 Trend Data and Patient (Numbers) ... 1 Clear Trend Data... 1

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Table of Contents

Chapter 9: PC Communication Setup

1

PC Trend Data Display ...1 Connect the PC to the Monitor ...1

Chapter 10: Maintenance

1

Maintenance Schedule ...1 Storage ...1

Chapter 11: Troubleshooting

1

EMI Interference...2

Chapter 12: Optional Supplies and Accessories

1

Ordering Information:...1 Equipment Classification ...1 Displays, Indicators and Keys ...1 SpO2 ...1 Pulse Rate ...2 Optional Printer ...2 Power Printer ...2 Battery Life ...2 Dimensions ...2 Environmental Specifications ...2

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Burdick® OXY 100 Operation Manual

Warranty & Service Information

Warranty & Service Information Proprietary Notice Information contained in this document is copyrighted by Cardiac Science Corporation and may not be duplicated in full or part by any person without prior written approval of Cardiac Science Corporation. Its purpose is to provide the user with adequately detailed documentation to efficiently install, operate, maintain and order spare parts for the device supplied. Every effort has been made to keep the information contained in this document current and accurate as of the date of publication or revision. However, no guarantee is given or implied that the document is error free or that it is accurate regarding any specification.

WARRANTY Limited Warranty Seller warrants to the original purchaser that the Product, not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with its labeling for two 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 ).

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 for 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 in 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. Burdick® OXY 100 Operation Manual

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CE Notice

Warranty Procedure To obtain warranty service in the USA, you must request a Return Material Authorization (RMA) number from Technical Support. Reference the RMA number when returning your Product, freight and insurance prepaid, to: Cardiac Science Corporation 500 Burdick Parkway Deerfield, Wisconsin 53531 U.S.A.

Phone: (608) 764-1919 Toll-Free: (800) 333-7770 Fax: (608) 764-7193

Website: www.cardiacscience.com/burdick Email: [email protected] 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.

CE Notice Marking by the symbol 2 indicates compliance of this device to the Medical Device Directive 93/42/EEC. Authorized Representative (as defined by the Medical Device Directive): Smiths Medical International Ltd. Colonial Way, Watford, Herts, UK WD24 4LG

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

Burdick® OXY 100 Operation Manual

Warnings, Cautions, & Notes

Warnings, Cautions, & Notes KEYWORD

DEFINITION

WARNING

Tells you about something that could hurt the patient or hurt the operator

CAUTION

Tells you something that could damage the monitor

NOTE

Tells you other important information

Symbol Definitions SYMBOL

r 2 1 D E D G B x 1 8 C

DEFINITION Type BF equipment Attention, consult accompanying documents Refer servicing to qualified service personnel Output voltage Input voltage Clear ID Direct current Alarm Silence On/Off Non AP device Speaker On/Off Use By

Warnings WARNING! Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician. 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! 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! 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.

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Warnings, Cautions, & Notes

WARNING! When attaching sensors with Microfoam®1 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! 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 950 for data processing equipment or IEC 601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC 601-1-1 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 601-1-1. WARNING! Patient safety can be compromised by the use of a power supply not supplied by Cardiac Science Corporation. Use only the power supply included with your monitor, or approved by Cardiac Science Corporation WARNING! IEC 950 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. PATIENT ENVIRONMENT

.9

5m

R

ft)

(4

1.

Cautions CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the sensors or monitor in liquid. Evidence that liquid has been allowed to enter the monitor voids the warranty. CAUTION! This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the information in this manual before using the device. CAUTION! Connect only the printer cable specifically intended for use with this device (see Optional Supplies and Accessories).

1

vi

Microfoam® is a registered trademark of the 3M Company

Burdick® OXY 100 Operation Manual

Warnings, Cautions, & Notes

Notes NOTE! Operation of this device may be adversely affected in the presence of strong electromagnetic sources, such as electrosurgery equipment. NOTE! Operation of this device may be adversely affected in the presence of computed tomograph (CT) equipment. NOTE! Use only SpO2 sensors supplied with, or specifically intended for use with, this device. NOTE! 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. NOTE! Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, patent blue V (PBV), and fluorescein, may adversely affect the accuracy of the SpO2 reading. NOTE! 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. NOTE! Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. NOTE! Batteries are user replaceable. Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. NOTE! SpO2 averaging is the number of pulse beats over which the SpO2 value is averaged; pulse averaging is the number of seconds over which the pulse value is averaged. NOTE! Hazards arising from software errors have been minimized. Hazard analysis was performed to meet EN1441: 1994. NOTE! 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.

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Chapter1: Introduction

Chapter 1: Introduction About the Manual The Operation Manual provides installation, operation, and maintenance instructions for health-care professionals and other users, trained in monitoring respiratory and cardiovascular activity.

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 photo detector. 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. Figure 1.0: Theory of Operation

1) Red and infrared LED light sources 2) Detector

The Pulse 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 pulse rate and calculate oxygen saturation. Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood. Since measurement of SpO2 depends on a pulsating vascular bed, 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 and SpO2 readings.

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Chapter 2: Intended Use and Features

Chapter 2: Intended Use and Features Intended Use The Burdick® OXY 100 Pulse Oximeter is: • A handheld, low cost monitor that is used for spot checking or attended monitoring of SpO2, pulse rate and pulse strength. • Battery powered. The Burdick® OXY 100 Pulse Oximeter may be used: • In a hospital or clinical environment. • During an emergency land transport. • For in-home use. The Burdick® OXY 100 Pulse Oximeter will: • Operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). • Work with all Cardiac Science Corporation oximetry sensors that are referenced in this manual, and provide SpO2 and pulse rate on all patients from neonate to adult. Note: The Burdick® OXY 100 Pulse Oximeter is not intended for continuous patient monitoring. Note: There are no audible or visible patient alarms.

Features The Burdick® OXY 100 Pulse Oximeter: • Provides fast, reliable SpO2, pulse rate, and pulse strength measurements on any patient, from neonates to adults. • Ideally suited for use in intensive care units, outpatient clinics, emergency rooms, during emergency air or land transport, or for in-home use. • Portable and lightweight. Weighs only 13 ounces, with batteries (369 grams). • Ergonomically designed to fit comfortably in the palm of your hand. • Uses four (4) standard “AA” (type IEC LR6) alkaline batteries. • Battery life is approximately 24 hours. • Bright, easy-to-read LED displays indicate SpO2 and pulse rate measurements. • An eight-segment LED bar graph indicates pulse strength. • Audible “beep” sounds with each pulse beat. Pitch of pulse “beep” corresponds to SpO2 value. • Low battery indicator lights when about 30 minutes of battery use remains. A high pitch beep also notifies the user of low battery life. • The automatic power down turns the unit off when not in use.

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Chapter 3: Monitor Assembly

Chapter 3: Monitor Assembly

2 WARNING! The monitor must be used in conjunction with clinical signs and symptoms. The monitor is only intended to be an adjunct in patient assessment.

Unpack the Monitor 1. Carefully remove the monitor and its accessories from the shipping carton. Note: Save all packing materials for future shipping or storage needs. 2. Refer to the supplied packing list to compare all contents that were shipped inside the carton. 3. Ensure that everything on the supplied packing list was shipped.

Install the Batteries The monitor uses 4 (four) standard “AA” alkaline cells, IEC Type LR6. To ensure the safety of trend data during battery replacement, the monitor will hold data for about one and one half minute with no battery power. Note: If disposable batteries are installed, be sure to dispose of them in compliance with your institution’s guidelines and local ordinances. Instructions: 1. Depress the bottom tab located on the battery cover and lift up. 2. Use the negative end of each battery to compress each battery terminal spring. Continue to compress each battery until the positive terminal clears the positive tab. 3. Press all batteries down into place. 4. Insert the battery cover tabs into the slots of the monitor’s back panel. 5. Depress the bottom tab of the battery cover again until the cover is locked into place. Figure 3.0: Installing the Batteries.

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Chapter 4: The Monitor

Chapter 4: The Monitor Turn On/Off the Monitor The monitor can be turned On/Off by pressing the x key. Once the monitor is turned on the following will be displayed: • The top segment of the pulse strength bar graph illuminates. • The monitor's software revision is momentarily displayed. • The patient number is momentarily displayed. Figure 4.1: SpO2, Pulse Rate, and Pulse Strength Bar graph.

%SpO2

BPM

1) Patient’s SpO2 2) Patient’s Pulse 3) Patient’s Pulse Strength

Monitor Automatic Power Down To conserve battery power, the monitor will automatically turn Off within two minutes, if: • The finger sensor is no longer attached to the patient. • The finger sensor is no longer connected to the monitor. A two minute interval will be extended if the monitor is: • Sending trend data to an external printer or PC. • In the Production Test Mode.

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Chapter 4: The Monitor

Check the Monitor’s Performance Figure 4.2: Connect the Oximeter/ECG Patient Simulator

4

5

%SpO2

BPM

4) Cable 5) Connector This monitor does not require ‘User Calibration’. To verify the monitor’s performance, use the optional Oximeter/ECG Patient Simulator: Cardiac Science Corporation catalog number: 010-1358-00 Note: The Oximeter/ECG Patient Simulator comes with a five foot long oximeter cable. The Oximeter/ECG Patient Simulator provides a known SpO2 and pulse rate signal to the monitor, thus allowing the monitor’s performance to be verified. Instructions: 1. Connect the cable to the monitor (as shown in Figure 4.1). 2. Follow the instructions that were supplied with the Oximeter/ECG Patient Simulator.

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Burdick® OXY 100 Operation Manual

Chapter 5: Monitor Display and Keypad

Chapter 5: Monitor Display and Keypad Monitor Display Figure 5.1: Monitor Display

L 8

1) Monitor Port The finger sensor, the oximeter cable, the printer cable and the DB-9 Null Modem cable connect to this monitor port. 2) SpO2 Numeric Display The monitor displays a continuous, real-time update of the patient’s SpO2 value in percent. Note: Displayed dashes (---) mean the monitor is not able to calculate the SpO2 value. 3) Pulse Rate Numeric Display The monitor displays a continuous, real-time update of the patient’s pulse rate value in beats per minute. Note: Displayed dashes (---) mean the monitor is not able to calculate the pulse rate value. 4) Pulse Strength Bar Graph The pulse strength bar graph “sweeps” with the patient’s pulse beat. The height of the bar graph shows the patient’s pulse strength. 5) Low Battery Indicator The low battery indicator is the highest LED segment of the pulse strength bargraph and will flash once every second if the battery is low (with only thirty minutes remaining).

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Chapter 5: Monitor Display and Keypad

Monitor Keypad Figure 5.2: Monitor Keypad

6) ON/OFF Key Press L to turn the monitor On/Off. 7) Clear ID Key Press D to clear patient trend data. 8) Speaker Silence Key To silence the speaker, press 8 for a moment. To enable speaker operation, press 8 for a moment.

Enable/Disable the Pulse Beep To enable/disable the pulse beep press the 8 key. The appropriate message [SP Off] or [SP On] will be displayed for two seconds. After two seconds the monitor will display the normal SpO2 and Pulse Rate measurements. Note: The speaker state will be recorded in non-volatile memory.

Low Battery Indicator

2 WARNING! When the LOW BATTERY INDICATOR flashes, you must immediately replace the monitor’s batteries. Otherwise, the monitor turns itself off about 30 minutes after the highest bargraph LED begins to flash. During a LOW BATTERY ATTENTION: • The bargraph’s highest LED segment will flash once every second. • Every minute, a series of five audible high pitch “beeps” will sound. Note: The low battery audible warning cannot be disabled by the 8 key. 5-2

Burdick® OXY 100 Operation Manual

Chapter 6: The Finger Sensor

Chapter 6: The Finger Sensor Connect the Finger Sensor to the Monitor

2 WARNING! Using a damaged finger sensor may cause inaccurate readings. If upon inspection a sensor appears damaged, do not use it. Use another finger sensor or contact an authorized repair center for help. Figure 6.0: Connect the Oximetery Cable

%SpO2

BPM

1) Connector 2) Cable With two fingers, hold the connector head, not the cable to connect the finger sensor to the monitor (as shown in Figure 6.0). Note: Do not use excessive force when connecting or disconnecting cables. Note: Do not use unnecessary twisting when using or storing cables. Note: An optional five foot long Oximeter Cable can be purchased to extend the length of the finger sensor.

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Chapter 6: The Finger Sensor

Clean or Disinfect the Finger Sensor

2 WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid.

2 WARNING! Unplug the sensor from the monitor before cleaning or disinfecting. Reusable sensors must be cleaned or disinfected before they are attached to the patient. To clean the sensor: • Use a soft cloth moistened in water or a mild soap solution. To disinfect the sensor: • Wipe the sensor with isopropyl alcohol.

Check the Integrity of the Finger Sensor

2 WARNING! If an integrity check fails, do not attempt to monitor the patient. Use another sensor, or contact the equipment dealer for help. The integrity of the sensor must be checked before the sensor is attached to the patient. Obstructions or dirt on the sensor’s red light or detector may cause checks to fail. Make sure there are no obstructions and the finger sensor is clean. Instructions: 1. If the monitor is not already on, press the x key. 2. Ensure there are no obstructions and the finger sensor is clean. 3. Go to the sensor and verify that the red light is illuminated.

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Burdick® OXY 100 Operation Manual

Chapter 7: Attach the Finger Sensor to the Patient

Chapter 7: Attach the Finger Sensor to the Patient

2 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.

2 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). Figure 7.0: Position the sensor cable

Instructions: 1. Select the appropriate sensor (Please see the ‘Finger Sensor Table’ shown below). 2. Inspect the finger sensor to ensure that it is not damaged. 3. Clean or disinfect the finger sensor. Note: Disposable sensors are for single-patient use only and do not require cleaning or disinfecting. 4. Position the cable parallel to the patient’s arm and across the patient’s palm (as shown in Figure 4.1). 5. Attach the finger sensor to the patient. Finger Sensor Table PATIENT Adult > 45 Kg

SITE

DESCRIPTION

Finger

047173: Sensor, Adult (reusable)

Finger or Toe

047172: Sensor, Universal “Y” (reusable) 047176: Sensor, Disposable, Adult Finger

Pediatric 15-45 Kg

Ear

047174: Sensor, Ear (reusable)

Finger

047173: Sensor, Adult (reusable)

Finger or Toe

047172: Sensor, Universal “Y” (reusable) 047175: Sensor, Disposable, Ped. Finger

Infant 3-15 Kg

Small Infant >30 days < 3 Kg

Ear

047174: Sensor, Ear (reusable)

Hand or Foot

047172: Sensor, Universal “Y” (reusable)

Toe

047170: Sensor, Wrap, Infant (reusable)

Finger or Toe

047178: Sensor, Disposable, Infant

Hand or Foot

047177: Sensor, Disposable, Neonate

Foot

047171: Sensor, Wrap, Neonate (reusable)

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Chapter 8: Trend Data

Chapter 8: Trend Data Trend Data Every thirty seconds, the monitor stores: • One SpO2 reading. • One pulse rate reading. Stored readings are called Trend Data. Depending on the battery condition, the monitor remembers Trend Data for: • Up to 99 patients. • 14 hours of run-time.

Trend Data and Patient (Numbers) Trend Data is saved for each patient (number), every time the monitor is turned on: • A new patient (number) will be displayed (incremented by one), if valid Trend Data was collected from a previous patient. • The previous patient (number) will be displayed (not incremented by one), if no valid Trend Data was collected from a previous patient. Without battery power, Trend Data will be saved for about one and a half minutes. Batteries need to be replaced within that time or Trend Data will be lost.

Clear Trend Data 1. Turn the monitor off, press the L key. 2. Press and hold the D key, do not release until further instructed. 3. Turn the monitor back on, press the L key. 4. [CLR] will flash on the monitors’ display. 5. When [CLR] stops flashing, the monitor will display [P1]. 6. [P1] means that the Trend Data is cleared, release the D key.

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