3301 Oximeter Operation and Service Manual Ver 4 Feb 2003

Table of Contents

Spot Check Printouts... 5-3 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

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Batteries ... 6-1 Disposal of batteries and rechargeable batteries ... 6-1 Sensors ... 6-1 Reusable Sensors... 6-1 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 Chapter 8: Optional Supplies & Accessories

8-1

Ordering Information:... 8-1 Chapter 9: Specifications

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Equipment Classification ... 9-1 Displays, Indicators, & Keys ... 9-1 SpO2 ... 9-1 Pulse Rate ... 9-2 Power Requirements ... 9-2 Battery Life ... 9-2 Dimensions ... 9-2 Environmental Specifications ... 9-2 Chapter 10: Service Maintenance & Repair

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General Description ... 10-1 Power Supply and ON/OFF Circuitry... 10-1 Digital Section ... 10-1 Analog Section... 10-2 LED Controller ... 10-3 Signal Dictionary ... 10-4 Test Equipment and Tools Required... 10-5 Connecting a DC Power Supply ... 10-6 Voltage Test Points ... 10-6 Waveform Test Points... 10-8 Functional Testing ... 10-10 Appendix ii

Appendix-1 Operation/Service Manual

Table of Contents

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

Operation/Service Manual

iii

Chapter 1: Introduction

Chapter 1: Introduction About This Manual The operator’s instructions provides installation, operation, and maintenance instructions. It is intended for health-care professionals trained in monitoring respiratory and cardiovascular activity. The operator’s instructions 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.

Proprietary Notice Information contained in this document is copyrighted by BCI, Inc. and may not be duplicated in full or part by any person without prior written approval of BCI, 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. 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 ).

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Chapter 1: Introduction

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. 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: BCI, Inc., N7 W22025 Johnson Road, Waukesha, WI 53186-1856. Telephone: 1-800-5582345. Facsimile: 262-542-3325. 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 service outside the USA, contact your local distributor. 1-2

Operation/Service Manual

Chapter 1: Introduction

CE Notice Marking by the symbol C0473 indicates compliance of this device to the Medical Device Directive 93/42/EEC. Authorized Representative (as defined by the Medical Device Directive): Graseby Medical Ltd. Colonial Way, Watford, Herts, UK, WD2 4LG

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

Symbol Definition SYMBOL

DEFINITION

2

Attention, consult accompanying documents.

r 7

Type BF equipment

REF

Catalog Number

SN

Serial number

R Q y 1 C

On

Refer servicing to qualified service personnel.

Off Date of Manufacture Non AP Device Use by

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Chapter 1: Introduction

2 Warnings, Cautions, & Notes WARNING: Federal law (USA) restricts this device to sale by, or on the order of, a physician. 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 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: Do not use this device in the presence of magnetic resonance imaging (MR or MRI) equipment. 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 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 601-1-1.

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Operation/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. .9

5m

R

(4

ft)

1.

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). 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. 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. (Notice: This device is not approved for home use by a non-health care professional.) CAUTION: Connect only the printer adapter specifically intended for use with this device (see Optional Supplies and Accessories). 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.

1

Microfoam® is a registered trademark of the 3M Company.

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Chapter 1: Introduction

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: The presence of dyshemoglobins, such as carboxyhemoglobin (with CO-poisoning) or methemoglobin (with sulfonamide therapy) may adversely affect the accuracy of the SpO2 measurement. NOTE: Hazards arising from software errors have been minimized. Hazard analysis was performed to meet EN1441: 1997. 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 opaque material.

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Operation/Service Manual

Chapter 2: Oximeter Features

Chapter 2: Oximeter Features 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 32 to 131° F (0 to 55° C). The oximeter works with all BCI, Inc. oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult.

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 9 ounces (255 grams) 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 bargraph indicates pulse strength.

•

Automatically turns off after patient’s finger is removed from the sensor.

•

Low battery indicator lights when about two hours of battery use remains.

•

Optionally connects to an external printer or computer, providing spot check printouts of SpO2 and pulse rate readings.

•

Collects up to seventeen (17) hours of spot check data for up to ninetynine (99) patients for printout later.

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Chapter 2: Oximeter Features

Description of Controls & Features

Figure 2-1: Oximeter Controls.

1. PATIENT CABLE/SENSOR The sensor connects here. If you need the extra length of the patient cable, attach the sensor to the patient cable, then attach the patient cable to the oximeter’s PATIENT CABLE/SENSOR connector. The serial printer or PC communication cable is also connected here. 2. % SpO2 DISPLAY The % SpO2 value is shown here. Dashes ( -- ) indicate the oximeter is unable to calculate the SpO2 value. 3. PULSE RATE DISPLAY The pulse rate value is shown in beats per minute (BPM). Dashes ( --- ) indicate the oximeter is unable to calculate the pulse rate value. Flashing 255 indicates the pulse rate value is greater than 255.

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Chapter 2: Oximeter Features

4. PULSE STRENGTH BARGRAPH The eight-segment bargraph “sweeps” with the patient’s pulse beat, indicating pulse strength. The bargraph is logarithmically scaled to indicate a wide range of pulse strengths. 5. R & Q KEYS Press “R” to turn on the oximeter. Press “Q” to turn off the oximeter. While the oximeter is on, momentarily pressing the “R” key increments the patient number. While the oximeter is on, pressing and holding the “R” key for about six seconds clears all the spot check data and resets the patient number to P1. The oximeter turns off automatically two minutes after the sensor is removed from the patient or after the sensor is disconnected from the oximeter. This feature extends the battery use time. 6. LOW BATTERY INDICATOR When about two hours of battery use time remains, the left-most bargraph segment lights. The oximeter will continue to operate normally until the batteries no longer have sufficient power to operate the oximeter. At that point, the oximeter automatically turns off. 7. BATTERIES AND ACCESS DOOR The oximeter’s three “C” cell batteries are accessed through this door on the back side of the oximeter. See Installing or Replacing the Batteries for details on installing or replacing the batteries.

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Chapter 3: Theory of Operation

Chapter 3: Theory of Operation The oximeter determines SpO2 and pulse rate by passing two wavelengths of 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.

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 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.

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Chapter 4: Using the Oximeter

Chapter 4: Using the Oximeter Unpack the Oximeter Carefully remove the oximeter and its accessories from the shipping carton. Save the packing materials in case the oximeter must be shipped or stored. Compare the packing list with the supplies and equipment you received to make sure you have everything you’ll need.

Install the Batteries The oximeter uses three standard “C” cell batteries (type LR 14). You can use disposable alkaline batteries or rechargeable (type KR27/50) batteries. If you use disposable batteries, be sure to dispose of them in compliance with your institution’s guidelines and local ordinances. If you use rechargeable batteries, it’s best to have two sets of batteries on hand. That way, you can use one set of batteries in the oximeter while the other set of batteries is recharging. NOTE: If you’ve collected spot check data for printing, make sure you print the spot check data before removing and replacing the oximeter’s batteries. Removing the batteries erases spot check data from the oximeter’s memory.

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Chapter 4: Using the Oximeter

Installing or Replacing the Batteries 1. Turn over the oximeter so its back is facing you. 2. Push on the thumb grip and slide the door open. 3. If you're replacing the batteries, remove the old batteries from the battery compartment. If the old batteries are disposable, be sure to dispose of them in compliance with your institution’s guidelines and local ordinances. If the old batteries are rechargeable, be sure to charge them right away so they'll be ready to use again as soon as possible. Figure 4-1: Opening the Battery Door.

4. Install three batteries in the oximeter battery compartment. Make sure the batteries are installed in the proper direction. NOTE: It is easiest to install the batteries in the sequence shown in Figure 4.2. 5. Slide the battery door closed, pushing firmly until it snaps into place.

Figure 4-2: Installing the Batteries.

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Chapter 4: Using the Oximeter

Care and Handling of Sensor Misuse or improper handling of the sensor and cable 2 WARNING! could result in damaging the sensor. This may cause inaccurate readings.

Hold the connector rather than the cable when connecting or disconnecting the finger sensor to the oximeter as shown in Figure 4.3.

Figure 4.3: Disconnecting or Connecting the Finger Sensor.

Do not use excessive force, unnecessary twisting, or kinking when connecting, disconnecting, storing, or when using the sensor. When placing the sensor on the patient, allow the cable to lay across the palm of the hand and parallel to the arm of the patient as shown in Figure 4.4.

Figure 4.4: Positioning the Cable of the Finger Sensor.

Upon completion of patient monitoring, detach the sensor and loosely coil finger sensor cable. Do not wrap the finger sensor cable around the oximeter.

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Chapter 4: Using the Oximeter

Choose the Sensor Choose the appropriate sensor from the following chart. Refer to the sensor insert for application instructions. Patient

Site

Description

Adult > 45 Kg

Finger

3044: Sensor, Adult 3444N : Sensor Adult

Finger or Toe

3043: Sensor, Universal “Y” 1300: Sensor, Disp., Adult Finger

Pediatric 15-45 Kg

Ear

3078: Sensor, Ear

Finger

3044: Sensor, Adult 3178: Sensor, Pediatric

Finger or Toe

3444N: Sensor Adult 3043: Sensor, Universal “Y”

Ear

1301: Sensor, Disp., Ped. Finger 3078: Sensor, Ear

Infant 3-15 Kg

Neonate < 3 Kg

4-4

Hand or Foot

3043: Sensor, Universal “Y”

Toe

3025: Sensor, Wrap, Infant

Finger or Toe

1303: Sensor, Disp., Infant

Hand or Foot

1302: Sensor, Disp., Neonate

Foot

3026: Sensor, Wrap, Neonate

Operation/Service Manual

Chapter 4: Using the Oximeter

Attach the Sensor to the Patient Prolonged use or the patient’s condition may require 2 WARNING: changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. When attaching sensors with Microfoam® tape, do not 2 WARNING: 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).

Clean or Disinfect the Sensors Clean or disinfect the reusable sensors before attaching a new patient. Do not autoclave, ethylene oxide sterilize, or immerse 2 WARNING: the sensors in liquid. Unplug the sensor from the monitor before cleaning or 2 CAUTION: disinfecting.

Clean the sensor with a soft cloth moistened in water or a mild soap solution. To disinfect the sensor, wipe the sensor with isopropyl alcohol. Finger Sensor for Adult or Pediatric Finger Attach the finger sensor to the patient as shown. Be sure to fully insert the patient’s finger into the sensor. For patients with long fingernails, use the universal “Y” sensor.

Figure 4.6: Attaching the Finger Sensor

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Chapter 4: Using the Oximeter

Attach the Sensor to the Oximeter •

Attach the sensor connector to the oximeter’s PATIENT CABLE/SENSOR connector.

•

If you need the extra length of the patient cable, attach the sensor to the patient cable, then attach the patient cable to the oximeter’s PATIENT CABLE/SENSOR connector.

Figure 4-7: Attach the Sensor to the Oximeter

Measuring the Patient’s % SpO2 and Pulse Rate To begin measuring the patient’s SpO2 and pulse rate, press the “R” key. When turned on, the oximeter goes through this power-up sequence: •

The pulse strength bargraph segments light one at a time.

•

The oximeter's software revision is momentarily displayed.

•

The patient number for spot check printouts is momentarily displayed. The format for the patient number display is “P” followed by the number. For example, P14 means the patient number is 14.

After a few seconds the % SpO2 value, pulse rate, and pulse strength bargraph should be shown. If not, see Operator’s Troubleshooting Chart for help.

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Chapter 4: Using the Oximeter

Figure 4-8: SpO2, Pulse Rate and Pulse Strength Bargraph.

1. Press On 2. % SPO2 value displayed 3. Pulse rate value displayed 4. pulse strength bargraph sweeping with patients pulse 5. low battery indicator The SpO2 display shows the patient’s blood oxygen saturation, calculated as a percentage. The pulse rate display shows the patient’s pulse rate in beats per minute (BPM). The pulse strength bargraph shows the patient’s pulse strength; the bargraph is scaled logarithmically to indicate a wide range of pulse strengths.

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