Model 3301 Oximeter Operation and Service Manual Ver 8 Sept 2007

Table of Contents

Table of Contents Revision History...vii Warranty and Service Information...ix Proprietary Notice...ix Warranty...ix Limited Warranty...ix Disclaimer of Warranties...ix Conditions of Warranty...x Limitation of Remedies...x Warranty Procedure...xi CE Notice...xii

Chapter 1: Introduction... 1-1 About This Manual...1-1 Definition of Symbols...1-1 Warnings, Cautions, and Notes...1-2

Chapter 2: Intended Use and General Information... 2-1 Intended Use...2-1 Monitor Features...2-1 Theory of Operation...2-2

Chapter 3: Controls and Features... 3-1 Description...3-1

Chapter 4: Operating Instructions... 4-1 Unpack the Oximeter...4-1 Install the Batteries...4-1 Installing or Replacing the Batteries...4-2 Care and Handling of Sensor...4-3 Choose the Sensor...4-4 Attach the Sensor to the Patient...4-5 Oximeter Operation and Service Manual 

Table of Contents Clean or Disinfect the Sensors...4-5 Finger Sensor for Adult or Pediatric Finger...4-5 Attach the Sensor to the Oximeter...4-6 Measuring the Patient’s % SpO2 and Pulse Rate...4-6 Patient Numbers and Spot Check Data...4-8 Manually Incrementing the Patient Number...4-8 Clearing All Spot Check Data...4-8 Low Battery Indicator...4-8 Turning Off the Oximeter...4-9 Checking the Oximeter’s Performance...4-9

Chapter 5: Printer and Computer Interface... 5-1 Computer Interface Description...5-1 Equipment Required...5-1 Communication settings...5-1 Interface Instructions...5-2 Collecting Spot Check Data...5-3 Manually Incrementing the Patient Number...5-3 Clearing All Spot Check Data...5-3 About the Oximeter’s Batteries and Spot Check Data...5-3 Printing Spot Check Data...5-4

Chapter 6: Operator’s Maintenance... 6-1 Batteries...6-1 Disposal of batteries and rechargeable batteries...6-1 Sensors...6-1 Reusable Sensors...6-2 Disposable Sensors...6-2 Cleaning the Oximeter’s Surfaces...6-2 Long Term Storage...6-2

Chapter 7: Operator’s Troubleshooting Chart... 7-1 EMI Interference...7-3 ii

Oximeter Operation and Service Manual

Table of Contents

Chapter 8: Optional Supplies and Accessories... 8-1 Ordering Information...8-2

Chapter 9: Specifications... 9-1 Equipment Classification...9-1 Displays, Indicators, & Keys...9-1 SpO2. ...9-2 Pulse Rate...9-2 Auxiliary Printer Output...9-2 Power Requirements...9-3 Battery Life...9-3 Dimensions...9-3 Environmental Specifications...9-3

Chapter 10: Guidance and Manufacturer’s Declaration... 10-1 Guidance and Manufacturer’s Declaration... 10-1 Electromagnetic Emissions - Emissions Test... 10-1 Electromagnetic Emissions – Immunity... 10-1 Recommended Separation Distances... 10-4

Chapter 11: Service Maintenance and Repair... 11-1 General Description... 11-1 Power Supply and ON/OFF Circuitry... 11-1 Digital Section... 11-2 Analog Section... 11-3 LED Controller... 11-5 Signal Dictionary... 11-5 Test Equipment and Tools Required... 11-7 Connecting a DC Power Supply... 11-7 Voltage Test Points... 11-8 Waveform Test Points... 11-9 Functional Testing...11-12 Oximeter Operation and Service Manual

iii

Table of Contents

Appendix... App-1 Assembly Drawings, Schematics & Parts Lists...App-1

iv

Oximeter Operation and Service Manual

Table of Contents BCI, Comfort Clip 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. The product described is covered by one or more of the following: U.S. Patent No. D351,023.

Oximeter Operation and Service Manual 

Table of Contents

This page is intentionally left blank.

vi

Oximeter Operation and Service Manual

Revision History

Revision History Revision

Date

Comment

Rev. 8

09-2007

• Updated Trademark and Patent Statement in Table of Contents. • Updated Warranty Statement and Proprietary Notice. • Added Australian Representative. • Updated symbols and definitions. • Updated About this Manual in Chapter 1. • Updated Warnings, Cautions, and Notes. • Added warnings for photodynamic therapy, erroneous readings, verifying LEDs light up. • Added cleaning caution. • Updated symbol table in Chapter 4. • Updated line art. • Updated Theory of Operation, SpO2 notes, 1606HH Simulator notes for ISO/EN9919:2005. • Took 1310 and 1311 out of parts list and sensor table. • Added pediatric kg to sensor descriptions. • Added desaturation test summary note to SpO2 Specifications. • Updated email address. • Added Guidance and Manufacturer’s Declaration. • Converted to Myriad Pro. Reformatted per CP30, CP31. • Added this Revision History

Oximeter Operation and Service Manual

vii

Revision History

This page is intentionally left blank.

viii

Oximeter Operation and Service 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 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 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.

Oximeter Operation and Service Manual

ix

Warranty and Service Information 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.



Oximeter Operation and Service Manual

Warranty and Service Information

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, Wisconsin 53186-1856

Telephone: (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 foam 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 occurred 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.

Oximeter Operation and Service Manual

xi

Warranty and Service Information

CE Notice

2

Marking by the symbol 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, 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

xii

Tel: +61 (0) 7 3340 1300

Oximeter Operation and Service Manual

Chapter 1: Introduction

Chapter 1: Introduction About This Manual This manual provides installation, operation, and maintenance instructions. It is intended for health-care professionals trained in monitoring respiratory and cardiovascular activity. The service maintenance and repair section contains circuit descriptions, voltage and waveform test points, detailed parts lists, and circuit diagrams. It is intended for persons trained in service, maintenance, and repair of modern medical equipment. Thorough knowledge of this equipment’s operation is required before attempting to repair this equipment. 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. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient.

Definition of Symbols symbol

definition

6

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

g

Attention, see instructions for use.

r 7

Type BF equipment

< > R Q y

Refer servicing to qualified service personnel. Catalog Number Serial number On Off Date of Manufacture

Oximeter Operation and Service Manual

1-1

Chapter 1: Introduction symbol

definition

1 8 Z

Non AP Device

IPX1

Drip Proof

2

Do not reuse. One use on one patient.

Use by Collect Separately

definition Tells you something that could hurt the patient or hurt warning the operator. caution Tells you something that could damage the device.

keyword

note

Tells you other important information.

Warnings, Cautions, and Notes WARNING! This device is not intended for continuous patient monitoring. This device is intended to measure the patient’s %SpO2 and pulse rate values. There are no audible or visible alarms. WARNING! 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. (Notice: This device is not approved for home use by a non-health care professional.) 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! Do not use this device in the presence of flammable anesthetics. WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically. Change the sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. 1-2

Oximeter Operation and Service Manual

Chapter 1: Introduction 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 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! Use only SpO2 sensors supplied with, or specifically intended for use with, this device. 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, patent blue V (PBV), and fluorescein, 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! Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. WARNING! The presence of dyshemoglobins, such as carboxyhemoglobin (with CO-poisoning) or methemoglobin (with sulfonamide therapy) may adversely affect the accuracy of the SpO2 measurement. 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 opaque material.

Oximeter Operation and Service Manual

1-3

Chapter 1: Introduction 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 lease every hour and observe for signs of tissue damage. More frequent sensor site changes or inspections may be indicated depending upon the photodynamic agent used, agent dose, skin condition, total exposure time or other factors. Use multiple sensor sites. 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 signal output port configures a medical system, and, therefore, is responsible that the system complies with the requirements of the system standard IEC 6011-1. 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).

1-4

Oximeter Operation and Service Manual

Chapter 1: Introduction WARNING! IEC 950 approved equipment must be placed outside of the “patient environment.” The patient environment is defined as an area 1.5 m (4.92 feet) from the patient. PATIENT ENVIRONMENT .9

R

1.5

m

(4

)

ft.

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. CAUTION! Observe proper battery polarity (direction) when replacing batteries. CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid. Evidence that liquid has been allowed to enter the monitor voids the warranty. Unplug the sensor from the monitor before cleaning or disinfecting. Oximeter Operation and Service Manual

1-5

Chapter 1: Introduction CAUTION! Connect only the printer adapter specifically intended for use with this device (see Optional Supplies and Accessories). CAUTION! Chemicals used in some cleaning agents may cause brittleness of plastic parts. Follow cleaning instructions in this manual.

1-6

Oximeter Operation and Service Manual

Chapter 2: Intended Use and General Information

Chapter 2: Intended Use and General Information Intended Use The oximeter provides fast, reliable SpO2 and pulse rate measurements. It can be used in the hospital or clinical environment, and during emergency air or land transport. The oximeter will operate accurately over an ambient temperature range of 0 to 55° C (32 to 131° F). The oximeter works with all BCI® oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult.

Monitor Features • Provides fast, reliable SpO2 and pulse rate measurements on any patient, from neonates to adults. • Ideally suited for use in intensive care units, in outpatient clinics, in emergency rooms, or during emergency air or land transport. • Portable and lightweight. Weighs only 255 grams (9 ounces) without the batteries. • Ergonomically designed to fit comfortably in the palm of your hand. • Uses three standard alkaline batteries (type LR 14) or three rechargeable (type KR27/50) NiCad “C” cell batteries. • Battery life is approximately twenty-four (24) hours in continuous mode or eighty (80) hours in spot check mode. • Bright, easy-to-read LED displays indicate SpO2 and pulse rate measurements. • An eight-segment LED bar graph indicates pulse strength. • Automatically turns off after patient’s finger is removed from the sensor. Oximeter Operation and Service Manual

2-1