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Summary of Contents for BCI 1884SS
- Page 1 Pulse Oximeter for Sleep Screening Operation Manual Catalog Number 1884SS Version 1, April 2002 Copyright BCI, Inc. - 2002...
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Page 3: Table Of Contents
Table of Contents Clinician’s Operation Manual Warranty & Service Information ....................iii Proprietary Notice ........................iii Limited Warranty ........................iii Service Support ........................... iii CE Notice............................iii Warnings, Cautions, & Notes Symbol Definitions ........................iv Warnings ............................iv Cautions ............................v Notes ..............................v Chapter 1: Introduction About the Manual......................... - Page 4 Table of Contents Chapter 7: Printer Description........................... 7-1 Trend Summary Printout ......................7-1 What You’ll Need for Printing ....................7-3 Trend Printouts ..........................7-4 Collecting Trend Data....................... 7-4 Paper Feed..........................7-4 Chapter 8: PC Communication Setup Description........................... 8-1 PC Communication Setup......................8-1 Chapter 9: Maintenance Schedule of Maintenance......................
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Page 5: Warranty & Service Information
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. -
Page 6: Warnings, Cautions, & Notes
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 DEFINITION Type BF equipment... -
Page 7: Cautions
Warnings, Cautions, & Notes 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. - Page 8 Warnings, Cautions, & Notes 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 SpO 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 SpO readings.
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Page 9: Chapter 1: Introduction
Chapter 1: 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 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. -
Page 11: Chapter 2: Intended Use And Monitor Features Intended Use
Chapter 2: Intended Use & 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 13: Chapter 3: Controls & Features
Chapter 3: Controls & Features Chapter 3: Controls & Features Monitor Front Panel Figure 3.1: Monitor Front Panel 1. 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. 2. -
Page 14: On Off Key
Chapter 3: Controls & Features Figure 3.2: Monitor Operating Keys ON OFF Key Pressing this key turns the monitor ON and OFF. PRINT Key See Chapter 4 for more details on the three modes. Verification Mode: In this mode, momentarily pressing the key will not activate the printer as the printer function is suppressed in this mode. -
Page 15: 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 1. 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 16: Attaching The Sensor To The Patient
Chapter 4: Operating instructions Attaching the Sensor to the Patient What you need to know about 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 17: 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 4.1. -
Page 18: 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. -
Page 19: Turning On The Monitor
Chapter 4: Operating Instructions Turning On the Monitor 1. To turn on the monitor, press the key. When turned ON, the monitor does the following: • The pulse strength bar graph segments rapidly light the bottom and top LED. • The monitor's software revision is momentarily displayed. -
Page 20: Low Battery Indicator
Chapter 4: Operating instructions Low Battery Indicator 1. The Low Battery Indicator is the top LED segment of the pulse strength bargraph. 2. The Low Battery Indicator will flash rapidly when the batteries need to be replaced. 3. The Low Battery Indicator and “trn” will flash rapidly if the monitor is trying to print and there is not enough battery life for printing. -
Page 21: 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. •... -
Page 22: Trend Printing Mode
Chapter 4: Operating instructions 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. • Momentarily pressing the key will not activate the printer in the Data Collection Mode. -
Page 23: 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. -
Page 25: 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. -
Page 27: 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: 1. - Page 28 Chapter 7: Printer • STD – The standard deviation is a measure of the variability of the sample. The larger the standard deviation of the sample data, the more variability there is in the sample. • Statistics - The statistics section contains information calculated from the valid data only. The following information is supplied in the statistics section: •...
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Page 29: What You'll Need For Printing
Chapter 7: Printer Figure 7.1: Sample Trend Printout Oximetry Title Summary STATISTICS %Time per SpO2 range Patient name %SpO2 %Time --------------- 95-99 Date 90-94 85-89 80-84 --------------- 70-79 Diagnosis 0-69 Patient Time per SpO2 Information --------------- range Comments %SpO2 Duration 95-99 00:06:00 Statistics... -
Page 30: Trend Printouts
Chapter 7: Printer Trend Printouts Collecting Trend Data 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 up to 12 hours of run-time, depending upon battery life. -
Page 31: Chapter 8: Pc Communication Setup
2. DB-9 Modem Cable (Catalog No.3339) PC Communication Setup 1. Power up the monitor. 2. Connect the printer communication cable labeled “BCI” to the monitor. 3. Connect the standard RS-232 null modem cable’s DB-9 connector to the mating connector of the printer cable labeled “Printer”. -
Page 33: Chapter 9: Maintenance
Chapter 9: Maintenance Chapter 9: Maintenance Schedule of Maintenance MAINTENANCE: HOW OFTEN: BY DOING THIS: Replace battery When Low Battery Indicator Follow the instructions for is flashing or 12-15 hours of installing the batteries. battery use has elapsed. Disinfect the reusable sensor Before attaching the sensor Follow the instructions for to the patient. -
Page 35: Chapter 10: Troubleshooting
Chapter 10: Troubleshooting Chapter 10: Troubleshooting Problem Possible Cause Corrective Action No pulse shown on the Patient cable or sensor Check sensor connections to the bargraph. is disconnected from the patient cable and to the oximeter. oximeter. Sensor is incorrectly Reposition the sensor. -
Page 36: Emi Interference
Chapter 10: Troubleshooting EMI Interference CAUTION: This device has been tested and found to comply within the limits for medical devices to IEC 601-1-2:1993, EN 60601-1-2:1994, and the Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. -
Page 37: Chapter 11: Optional Supplies & Accessories
Comfort Clip™ finger Sensor each 6012 Paper, Printer 4/pk Ordering Information: For ordering information, contact your local distributor or the BCI, Inc. customer service department. BCI, Inc. Phone: (262) 542-3100 N7 W22025 Johnson Road Fax: (262) 542-3325 Waukesha, WI USA 53186-1856 Toll Free;... -
Page 39: Chapter 12: Specifications
Chapter 12: Specifications Chapter 12: Specifications Equipment Classification Type of Protection Against Internally Powered Electric shock: Mode of operation: Continuous Degree of Protection Against IPX1, drip proof ingress of Liquids: Degree of Mobility: Portable Degree of Protection Against Type BF Electric Shock: Safety Requirements: EN60601-1: 1990... -
Page 40: 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 41: Appendix A: Data Format
Appendix A: Data Format Appendix A: Data Format 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 42: Appendix B: Setting The Optional Real Time Clock
Appendix A: Data Format The following table shows an example of data de-compression: Byte in HEX De-compression Marker byte, expect the next byte to be SpO2; SpO2 value, HEX 60 equals to 96% SpO2 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;... - Page 43 Smiths Medical – a part of Smiths Group plc 0473 Authorized Representative (as defined by the Medical Device Directive): Graseby Medical Ltd. Phone: (44) 1923 246434 Colonial Way, Watford, Herts, Fax: (44) 1923 240273 UK WD2 4LG...
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