Smiths Medical 1884SS Operation Manual
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Smiths Medical 1884SS Operation Manual

Smiths Medical 1884SS Operation Manual

Pulse oximeter for sleep screening
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Pulse Oximeter
for Sleep Screening
Operation Manual
%SpO2
B P M
F
x
- English
Catalog Number 1884SS
Version 5, May 2007
© 2007 Smiths Medical Family of Companies. All rights reserved.

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  • Page 1 Pulse Oximeter for Sleep Screening Operation Manual %SpO2 B P M - English Catalog Number 1884SS Version 5, May 2007 © 2007 Smiths Medical Family of Companies. All rights reserved.

  • Page 3: Table Of Contents

    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 ............................v Limitation of Remedies ............................v Warranty Procedure ............................vi CE Notice ..................................vi Chapter 1: Introduction ................... 1-1 About this Manual ..............................1-1 Definition of Symbols ............................1-1 Warnings ..................................1-1...
  • Page 4 Table of Contents Chapter 5: Instructions for Training the Home User ........5-1 Equipment and Supplies Checklist for Home Use ..................5-1 Training the Home User ............................5-1 Chapter 6: Trend Data ..................6-1 Description ................................6-1 Clearing Trend Data ..............................6-1 Chapter 7: Printer ..................... 7-1 Description ................................7-1 Trend Summary Printout .............................7-1 What You’ll Need for Printing ..........................7-4...
  • Page 5 Electromagnetic Emissions – Immunity ....................C-1 Recommended Separation Distances ......................C-4 Appendix D: Revision History ................D-1 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.
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  • Page 7: 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.

  • Page 8: 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. Phone: (262) 542-3100 N7W22025 Johnson Drive...

  • Page 9: Chapter 1: Introduction

    Chapter 1: Introduction Chapter 1: Introduction About this Manual The Operation Manual provides installation, 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.
  • Page 10 Chapter 1: Introduction WARNING! Do not use this device in the presence of magnetic resonance imaging (MR or MRI) equipment. 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 and/or the “Home User’s Guide”...
  • Page 11 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 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.

  • Page 12: Cautions

    Chapter 1: Introduction Cautions 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! Connect only the PC cable specifically intended for use with this device (see Optional Supplies and Accessories).

  • Page 13: Chapter 2: Intended Use And Monitor Features

    Chapter 2: Intended Use and Monitor Features Chapter 2: Intended Use and Monitor Features Intended Use This device is a handheld pulse oximeter that measures SpO , pulse rate, and pulse strength. It may be used as a spot check device in the hospital or clinical environments. Additionally, it may be used to collect long term data in overnight sleep screening studies in the sleep lab or home.

  • Page 14: Theory Of Operation

    Chapter 2: Intended Use and Monitor Features Theory of Operation The pulse oximeter determines %SpO 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 SpO Specifications section of this manual.

  • Page 15: Chapter 3: Controls And Features

    Chapter 3: Controls and Features Chapter 3: Controls and Features Monitor Front Panel %SpO2 B P M Figure 3.1: Monitor Front Panel Sensor/Serial Connector The sensor connects here, or an oximetry cable can be connected between the monitor and the sensor. The serial printer or PC communication cable is also connected here. Numeric Display A number shows the patient’s SpO value in percent.

  • Page 16: Monitor Operating Keys

    Chapter 3: Controls and Features Monitor Operating keys %SpO2 B P M Figure 3.2: Monitor Operating Keys ON OFF key Pressing this key turns the monitor ON and OFF. PRINT key • Verification Mode: In this mode, momentarily pressing the key will not activate the printer as the printer function is suppressed in this mode.

  • Page 17: Chapter 4: Operating Instructions

    Chapter 4: Operating Instructions Chapter 4: Operating Instructions 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. Unpacking the Monitor Carefully remove the monitor and its accessories from the shipping carton. Save the packing materials in case the monitor must be shipped or stored.

  • Page 18: Attaching The Sensor To The Patient

    Chapter 4: Operating Instructions Attaching the Sensor to the Patient WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically. Patients setting up the device at home should be instructed of the signs/symptoms of sensor misuse (e.g., pressure sores from prolonged application) and should be advised to move the sensor to another finger if necessary.

  • Page 19: Care And Handling Of The Sensor

    Chapter 4: Operating Instructions Care and Handling of the Sensor WARNING! Misuse or improper handling of the sensor and cable could result in damage to the sensor. This may cause inaccurate readings. Hold the connector rather than the cable when connecting or disconnecting the sensor to the device as shown in Figure 4.2.

  • Page 20: Checking The Sensor And Oximetry Cable

    Chapter 4: Operating Instructions Checking the Sensor and Oximetry Cable Follow these instructions each time before you attach the sensor to the patient. This helps ensure the sensor and oximetry cable is working properly. WARNING! Using a damaged sensor may cause inaccurate readings. Inspect each sensor. If a sensor appears damaged, do not use it.

  • Page 21: Turning On The Monitor

    Chapter 4: Operating Instructions %SpO2 Low Battery Patient’s SpO Indicator Pulse Rate Pulse Strength B P M Figure 4.4: SpO , pulse rate, and pulse strength bar graph. Turning On the Monitor To turn on the monitor, press the key. WARNING! Verify that all LEDs (light emitting diodes) on the display light up upon startup of the device.

  • Page 22: Turning Off The Monitor

    Chapter 4: Operating Instructions Turning Off the Monitor Turn off the monitor when you are not monitoring a patient. To turn off the monitor, press the key. To turn off the monitor in the Data Collection Mode, key must be pressed and held for 6 seconds. NOTE! Once the monitor is powered off in the Data Collection Mode, it cannot resume collection of trend data without clearing all previously obtained data.

  • Page 23: Verification Mode

    Chapter 4: Operating Instructions Verification Mode Verification Mode is intended for use in spot checking and for verifying that the user has correct placement of the finger sensor. The monitor will enter the Verification Mode as soon as trend memory is cleared. In this mode the patient will be able to position the sensor on his/her finger (or appropriate site) and obtain SpO and heart rate data on the display.

  • Page 24: Data Collection Mode

    Chapter 4: Operating Instructions Data Collection Mode Data Collection Mode is intended for use in long-term collection of data in sleep screening environments. The Data Collection Mode will be entered when the verification timer reaches 10 minutes. Once the trend data collection process has been started, trend memory will be filled continuously until the end-of-memory is detected (approx.

  • Page 25: Trend Printing Mode

    Chapter 4: Operating Instructions Trend Printing Mode The Trend Printing Mode is intended for use in the output of the trend data summation to the built-in printer or to a PC for a full computer data download. The Trend Printing Mode is entered after the monitor is powered down in the Data Collection Mode, and powered back up, or when the trend memory becomes full.
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  • Page 27: Chapter 5: Instructions For Training The Home User

    Chapter 5: Instructions for Training the Home User Chapter 5: Instructions for Training the Home User Equipment and Supplies Checklist for Home Use QUANTITY CAT. NO. DESCRIPTION Handheld Oximeter 1884SSHU Home Users Guide * The physician or home care provider will provide the type and quantity of the sensors needed for home use.
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  • Page 29: Chapter 6: Trend Data

    Chapter 6: Trend Data Chapter 6: Trend Data Description Whenever the monitor is on, it stores one SpO and one pulse rate reading every 4 seconds. The stored readings are called trend data. The monitor remembers trend data for at least 12 hours of run-time, possibly more, depending upon battery condition.
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  • Page 31: Chapter 7: Printer

    Chapter 7: Printer Chapter 7: Printer Description Up to 12 hours of previously stored data can be printed as a summation of data from the monitors built-in printer or as a data download to a computer. Trend Summary Printout To print the trend summary from the monitor’s built-in printer: The monitor must be in the Trend Printing Mode.
  • Page 32 Chapter 7: Printer Study Maximums and Minimums – The study maximums and minimums section contains the following information: • Low SpO – The lowest recorded SpO value taken from the total valid sample. • Time of Lowest SpO – Records the time the lowest SpO reading occurred (clock does not ignore invalid data when determining lowest SpO time).
  • Page 33 Chapter 7: Printer Figure 7.1: Sample Trend Printout Oximetry Title Summary STATISTICS Patient name %Time per SpO2 range %Time %SpO2 --------------- 19.5 95-99 Date 90-94 16.1 16.1 85-89 16.1 80-84 --------------- 70-79 16.1 Diagnosis 16.1 Patient 0-69 Information Time per SpO2 --------------- range Comments...

  • Page 34: What You'll Need For Printing

    Chapter 7: Printer What You’ll Need for Printing You’ll need these items to print trend printouts: • Oximeter with installed printer. • Printer Paper: 1-inch wide thermal, Catalog No. 6012. Trend Printouts Collecting Trend Data • Whenever the monitor is on, it stores one SpO and one pulse rate reading every 4 seconds.

  • Page 35: Paper Feed

    Chapter 7: Printer Paper Feed To advance paper through the printer: Press and hold for 3 seconds (not at power up). The paper-feed will start. Press the key again to stop the printer, otherwise the printer will stop in about 25 seconds after printing 30 empty lines.
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  • Page 37: Chapter 8: Pc Communication Setup

    Chapter 8: PC Communication Setup Chapter 8: PC Communication Setup Description ® This device has been designed for use with the BCI 1621 Oximetry Data Management Program. This device will send out trend data to a PC running the 1621 software. The 1621 software will then analyze the data and output summary information.
  • Page 38 Chapter 8: PC Communication Setup Figure 8.1: PC Communication Setup 3389 Proprietary Serial Cable %SpO2 B P M DB9 Printer Connector WARNING! The program will not function without the 3389 Proprietary Serial Cable. WARNING! The program will not function if the monitor and cable are not properly connected.

  • Page 39: Chapter 9: Maintenance

    Chapter 9: Maintenance Chapter 9: Maintenance Schedule of Maintenance MAINTENANCE HOW OFTEN BY DOING THIS Replace battery. When Low Battery Follow the instructions for installing the batteries. Indicator is flashing or 12-15 hours of battery use has elapsed. Disinfect the reusable Before attaching the Follow the instructions for cleaning the reusable sensor.
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  • Page 41: Chapter 10: Troubleshooting

    No trends in memory. Take trend data. Printer interface Contact your authorized repair center for help. malfunction. ROM Error Contact Smiths Medical PM, Inc. service representative RAM Error Contact Smiths Medical PM, Inc. service representative Pulse Oximeter for Sleep Screening Operation Manual...

  • Page 42: Emi Interference

    Reorient or relocate the other receiving device. • Increase the separation between the interfering equipment and this equipment. If assistance is required, contact the Smiths Medical PM, Inc. Service Department or your local representative. 10-2 Pulse Oximeter for Sleep Screening Operation Manual...

  • Page 43: Chapter 11: Optional Supplies & Accessories

    , Finger 6012 Paper, Printer 4/pk Ordering Information For ordering information, contact your local distributor or the Smiths Medical PM, Inc. customer service department at the address or phone number below. Smiths Medical PM, Inc. Phone: (262) 542-3100 N7W22025 Johnson Drive...
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  • Page 45: Chapter 12: Specifications

    Chapter 12: Specifications Chapter 12: Specifications Equipment Classification Type of Protection Against Electric shock: Internally Powered Mode of operation: Continuous Degree of Protection Against ingress of IPX1, drip proof Liquids: Degree of Mobility: Portable Degree of Protection Against Electric Shock: Type BF Safety Requirements: EN60601-1: 1990...

  • Page 46: Pulse Rate

    Chapter 12: Specifications Pulse Rate Range: 30-254 BPM (1 bpm increments) Accuracy: ±2% or 2 BPM, which ever is greater Averaging: 8 second average Display Update Rate: 1 Hz Printer 1 inch wide paper thermal printer (# 6012) 15 characters per line with two dots between symbols 5x7 dot characters Power Requirements Four standard “AA”...

  • Page 47: Appendix A: Data Format

    Appendix A Appendix A: Data Format Description The device will send out Trend Data to a PC through the sensor connector. To accomplish this, the sensor must be disconnected from the device. Additional cables are required to connect the device to a PC. The communication device will be dormant if the system is not in the Trend Printing Mode.

  • Page 48: Output Data Format

    Appendix A Output Data format Baud rate: 19200, 8 bits, one start, one stop, no parity check. Data output starts in the Trend Printing Mode as soon as power is turned on. Data transmission is unidirectional from the oximeter to the receiving device. The CTS (clear- to-send) line from the receiving device to the oximeter can be used to control data flow.
  • Page 49 Appendix A The following table shows an example of data decompression: BYTE IN HEX DECOMPRESSION Marker byte, expect the next byte to be SpO value, HEX 60 equals to 96% SpO decimal, expect the next byte to be Pulse Rate Pulse Rate, HEX 52 equals to 82 bpm decimal, expect the next byte to be the byte divided into low and high nibbles Low nibble is 0, SpO...
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  • Page 51: Appendix B: Setting The Optional Real Time Clock

    Appendix B Appendix B: Setting the Optional Real Time Clock Clear trend memory by pressing and holding the print key at power up until CLR stops flashing. Turn the monitor off. Power on the monitor and continue to hold the on key for 6-8 seconds. The version number should be displayed and then the display will go blank except for one set of digits.
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  • Page 53: Appendix C: Guidance And Manufacturer's Declaration

    Appendix C: Guidance and Manufacturer’s Declaration Appendix C: Guidance and Manufacturer’s Declaration Guidance and Manufacturer’s Declaration The 3403 pulse oximeter is intended for use in the electromagnetic environment specified in the tables within this appendix. NOTE! The customer or user of the 3403 pulse oximeter should ensure that it is used in such an environment.
  • Page 54 Appendix C: Guidance and Manufacturer’s Declaration IMMUNITY ELECTROMAGNETIC ENVIRONMENT GUIDANCE IEC 60601 TEST LEVEL A.C. Mains power voltage should be the typical Electrical fast transient/burst IEC 61000-4-4 quality of a: • NA for power supply lines. • Commercial environment. • ±0.25 kV to ±1 kV for input/output •...
  • Page 55 Appendix C: Guidance and Manufacturer’s Declaration IMMUNITY ELECTROMAGNETIC ENVIRONMENT GUIDANCE IEC 60601 TEST LEVEL Power frequency magnetic fields should be the Power frequency (50/60 Hz) IEC 61000-4-8 typical levels of a: 3 A/m • Commercial environment COMPLIANCE LEVEL • Hospital environment 3 A/m Conducted RF IEC 60601 TEST LEVEL Recommended separation distance:...

  • Page 56: Recommended Separation Distances

    Appendix C: Guidance and Manufacturer’s Declaration Recommended Separation Distances The 3403 pulse oximeter is intended for use in an electromagnetic environment where radiated RF disturbances are controlled. The customer or the user of the 3403 pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 3403 pulse oximeter as recommended below, according to the maximum output power of the communications equipment.

  • Page 57: Appendix D: Revision History

    Appendix D: Revision History Appendix D: Revision History REVISION DATE COMMENT • Added new design theme frame to front cover. Rev. 5 05-2007 • Added the Smiths design mark to list of trademarks. • Updated Proprietary Note in Warranty section. •...
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  • Page 60 Authorized Representative (as defined by the Medical Device Directive): Smiths Medical International, Ltd. Phone: (44) 1923 246434 Colonial Way, Watford, Herts, Fax: (44) 1923 240273 WD24 4LG, UK Manufactured By Smiths Medical PM, Inc. Patient Monitoring and Ventilation N7W22025 Johnson Drive...

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