Finger Oximeter 1900 Operation Manual Ver 11 Oct 2006

Table of Contents

Table of Contents Warranty & Service Information

v

Proprietary Notice...v Warranty...v Limited Warranty...v Disclaimer of Warranties...v Conditions of Warranty...vi Limitation of Remedies...vi Warranty Procedure...vi CE Notice... vii

Chapter 1: Introduction

1-1

About this Manual...1-1 Warnings...1-2 Cautions...1-3 Notes...1-4

Chapter 2: Intended Use and Features

2-1

Intended Use...2-1 Device Features...2-1 Theory of Operation...2-2

Chapter 3: Controls and Features

3-1

Front Panel . ...3-1

Chapter 4: Operating Instructions

4-1

Unpacking the Pulse Oximeter...4-1 Packing List...4-1 Install the Batteries...4-2 Attaching the Pulse Oximeter to the Patient...4-3 Care and Handling of the Pulse Oximeter...4-3 Cleaning or Disinfecting the Pulse Oximeter...4-3

Finger Oximeter Operation Manual



Table of Contents Low Battery Indicator...4-4 Turning Off the Pulse Oximeter...4-4

Chapter 5: Maintenance

5-1

Schedule of Maintenance...5-1 Storage...5-2

Chapter 6: Troubleshooting

6-1

EMI Interference...6-2

Chapter 7: Optional Supplies & Accessories

7-1

Ordering Information...7-1

Chapter 8: Specifications

8-1

Equipment Classification...8-1 Displays, Indicators, & Keys...8-1 SpO2. ...8-1 Pulse Rate...8-2 Pulse Strength...8-2 Power Requirements...8-2 Battery Life...8-2 Dimensions...8-2 Environmental Specifications...8-2

Appendix A: Revision History

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A-1

Finger Oximeter Operation Manual

Table of Contents The Smiths design mark is a trademark 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. The product described is covered by U.S. Patent No. 6,654,621.

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Table of Contents

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Finger Oximeter Operation Manual

Warranty & Service Information

Warranty & Service Information

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 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 two years from the date of shipment to the original purchaser. 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.

Finger Oximeter Operation Manual



English

Proprietary Notice

Warranty & Service Information Conditions of Warranty This warranty is void if the Product has been altered, misused, damaged by neglect or accident, not properly maintained, 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. Warranty Procedure To obtain warranty service in the USA, you must request a Customer Service Report (CSR) number from Technical Service. Reference the CSR 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 Toll Free (in USA only): 1-800-558-2345 Fax: 262-542-0718

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.

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Finger Oximeter Operation Manual

Warranty & Service Information

CE Notice

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

Finger Oximeter Operation Manual

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

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English

2

Marking by the symbol indicates compliance of this device to the Medical Device Directive 93/42/EEC.

Warranty & Service Information

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Finger Oximeter Operation Manual

Chapter 1: Introduction

Chapter 1: Introduction English

About this Manual The Operation Manual provides operation and maintenance instructions for health-care professionals and other users trained in monitoring respiratory and cardiovascular activity. 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 oximeter.

Definition of Symbols symbol

definition

r

Type BF equipment

7

Refer servicing to qualified service personnel.

2

Attention, see instructions for use.

%SpO2

Percent oxygen saturation (functional)

p

Pulse rate (beats per minute) Low Battery

O SpO2

On Device does not have alarms

6

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

1

Non AP device

IPX1

Drip Proof

Z > <

Collect Separately Serial number Catalog number

Finger Oximeter Operation Manual

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Chapter 1: Introduction 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

Warnings 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 application site periodically. Change application site and check skin integrity, circulatory status, and correct alignment at least every 30 minutes. WARNING! Operation of this device may be adversely affected in the presence of strong electromagnetic sources, such as electrosurgery equipment. WARNING! Operation of this device may be adversely affected in the presence of computed tomography (CT) equipment. 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.

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Finger Oximeter Operation Manual

Chapter 1: Introduction

English

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! Do not use the oximeter on infant or neonatal patients. WARNING! Significant levels of dysfunctional hemoglobins (methemoglobin or carboxyhemoglobin) will affect the accuracy of SpO2 readings.

Cautions CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the pulse oximeter in liquid. CAUTION! Do not allow water or any other liquid to enter the monitor. 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 who have a complete understanding of pulse oximetry. The operator must be thoroughly familiar with the information in this manual before using the device. CAUTION! Pressing key with sharp or pointed instruments may permanently damage the keypad. Press the key with your finger only. CAUTION! Remove fingernail polish or false fingernails before applying the pulse oximeter. Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

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Chapter 1: Introduction

Notes NOTE! Batteries are user replaceable. Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. NOTE! Hazards arising from software errors have been minimized. Hazard analysis was performed to meet EN60601-1-4. 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. NOTE! Be sure to dispose of batteries in compliance with your institutions guidelines and local ordinances.

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Finger Oximeter Operation Manual

Chapter 2: Intended Use and Features

Chapter 2: Intended Use and Features

This device is a pulse oximeter that combines the monitor and sensor into one assembly that measures SpO2, pulse rate, and pulse strength on the finger. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The pulse oximeter will provide reliable measurements on patients ranging from pediatric to adults. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.

Device Features • Provides fast, reliable SpO2 and pulse rate measurements on any patient, from pediatric to adults. • Ideally suited for use in outpatient clinics, emergency rooms, during emergency land transport, or for in-home use. • Portable and lightweight. Weighs only 3 ounces, with batteries (85 grams). • Uses two (2) standard “AAA” (type IEC LR03) alkaline batteries. • Battery life is approximately sixteen (16) hours continuous use, 1400 spot checks (1 minute on 2 minutes off ), and 4 years shelf life. • Bright, easy-to-read LED displays indicate SpO2 and pulse rate measurements. • Low battery indicator lights when about 30 minutes of battery use remains. • The automatic power down turns the unit off when not in use.

Finger Oximeter Operation Manual

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English

Intended Use

Chapter 2: Intended Use and 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. 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 2.1: Theory of Operation

1

2 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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Finger Oximeter Operation Manual

Chapter 3: Controls & Features

Chapter 3: Controls and Features English

Front Panel Figure 3.1: Monitor Front Panel

%SpO2

3

M

98 120 p

4 1 2

1) SpO2 Numeric Display A number shows the patient’s SpO2 value in percent. Dashes (---) mean the pulse oximeter is not able to calculate the SpO2 value. 2) Pulse Rate Numeric Display A number shows the patient’s pulse rate value in beats per minute. Dashes (---) mean the pulse oximeter is not able to calculate the pulse rate value. 3) Pulse Strength Indicator A six segment bargraph indicates the logarithmic strength of a patient’s pulse. 4) Low Battery Indicator During a Low Battery Attention, the Low Battery LED flashes about once every second.

Finger Oximeter Operation Manual

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Chapter 3: Controls & Features

Figure 3.2: Monitor Operating Keys

5)

O

On (Monitor automatically shuts off) Depressing the O button turns the monitor on.

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Finger Oximeter Operation Manual

Chapter 4: Operating Instructions

Chapter 4: Operating Instructions

Unpacking the Pulse Oximeter 1. Carefully remove the pulse oximeter and its accessories (see Ch. 7) from the shipping carton. Save the packing and shipping materials in case the monitor must be shipped or stored. 2. Compare the packing list with the supplies and equipment you received to make sure you have everything you’ll need. Packing List Description

Quantity

Finger Oximeter

1

Operation Manual

1

Lanyard

1

Battery Compartment

1

AAA Batteries

2

Finger Oximeter Operation Manual

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English

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.

Chapter 4: Operating Instructions

Install the Batteries The oximeter uses two (2) standard “AAA” alkaline cells, IEC Type LR03. To install/replace the batteries: 1. Depress the battery door tab and lift up. 2. Install the battery in accordance with the engraved drawing on the inside of the battery compartment. 3. Place the battery compartment into the pulse oximeter and press down to compress the batteries and springs. 4. Rotate the battery compartment towards the pulse oximeter until it is flat against the pulse oximeter and then release the battery compartment to allow it to snap into place. Figure 4.1: Installing the batteries

3

1

2

NOTE! If you install disposable batteries, be sure to dispose of them in compliance with your institution’s guidelines and local ordinances.

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Finger Oximeter Operation Manual

Chapter 4: Operating Instructions

Attaching the Pulse Oximeter to the Patient

WARNING! Prolonged use or the patient’s condition may require changing the application site periodically. Change the application site and check skin integrity, circulatory status, and correct alignment at least every 30 minutes. Attaching the patient to the pulse oximeter requires these steps: 1. Check the pulse oximeter. 2. Clean or disinfect the pulse oximeter. 3. Attach the pulse oximeter to the patient by inserting the patient’s finger into the device until the finger tip touches the stop guide. The oximeter must be positioned with the LED display facing up and visible to the clinician at all times. 4. Make sure the finger is centered over the light and detector. 5. To turn on the pulse oximeter, press the O key at the fingertip of the device. When turned ON, the device’s monitor software revision is temporarily displayed.

Care and Handling of the Pulse Oximeter WARNING! Misuse or improper handling of the pulse oximeter could result in damage to the device. This may cause inaccurate readings. NOTE! Obstructions or dirt on the pulse oximeter’s red light or detector may cause the checks to fail. Make sure there are no obstructions and the device is clean. Cleaning or Disinfecting the Pulse Oximeter Clean or disinfect the pulse oximeter before attaching to a new patient. WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the pulse oximeter in liquid. Clean the pulse oximeter with a soft cloth moistened in water or a mild soap solution. To disinfect the pulse oximeter, wipe it with isopropyl alcohol. Finger Oximeter Operation Manual

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English

What you need to know about attaching the pulse oximeter to the patient: