Pulse Oximeter for Sleep Screening Operation Manual Catalog Number 1884SS Version 1, April 2002 Copyright BCI, Inc.
Table of Contents Clinician’s Operation Manual Warranty & Service Information ................................................................................................... iii Proprietary Notice ....................................................................................................................... iii Limited Warranty ........................................................................................................................ iii Service Support ............................
Table of Contents Chapter 7: Printer 7-1 Description................................................................................................................................... 7-1 Trend Summary Printout ............................................................................................................. 7-1 What You’ll Need for Printing .................................................................................................... 7-3 Trend Printouts .................................
Warranty & Service Information Warranty & Service Information 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.
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 r 2 1 Type BF equipment SN Serial Number Attention, consult accompanying documents Refer servicing to qualified service personnel REF Catalog Number F y 2 x 1 l C Printer On/Off IPX1 Drip Proof
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. All combinations of equipment must be in compliance with IEC 601-1-1 systems requirements.
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 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.
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 SpO2 and pulse rate by passing two wavelengths of low intensity light, one red and one infrared, through body tissue to a photodetector.
Chapter 2: Intended Use & Monitor Features Chapter 2: Intended Use and Monitor Features Intended Use This device is a handheld pulse oximeter that measures SpO2, 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.
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. SpO2 Numeric Display A number shows the patient’s SpO2 value in percent. Dashes (--) mean the monitor is not able to calculate the SpO2 value in Verification Mode.
Chapter 3: Controls & Features Figure 3.2: Monitor Operating Keys 6. x ON OFF Key Pressing this key turns the monitor ON and OFF. 7. F PRINT Key See Chapter 4 for more details on the three modes. Verification Mode: In this mode, momentarily pressing the F key will not activate the printer as the printer function is suppressed in this mode. Pressing and holding the F key in the Verification Mode will advance the paper. Reloading the paper is allowed in this mode.
Chapter 4: Operating Instructions Chapter 4: Operating Instructions 2 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. 2.
Chapter 4: Operating instructions Attaching the Sensor to the Patient What you need to know about attaching the sensor to the patient: 2 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.
Chapter 4: Operating Instructions Care and Handling of the Sensor 2 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. Figure 4.1: Disconnecting or connecting the sensor. 1. Connector 2.
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. 2 WARNING! Using a damaged sensor may cause inaccurate readings. Inspect each sensor. If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair center for help. 2 WARNING! Using a damaged oximetry cable may cause inaccurate readings.
Chapter 4: Operating Instructions Turning On the Monitor 1. To turn on the monitor, press the x 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. Figure 4.3: SpO2, pulse rate, and pulse strength bar graph. 1. Patient’s SpO2 Shown Here 2. Patient’s Pulse Shown Here 3.
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. This indicator will go away when the printing stops.
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 SpO2 and heart rate data on the display. • This mode will last for 10 minutes of continuous valid data collection.
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 F key will not activate the printer in the Data Collection Mode. The printer function is suppressed in this mode. • Pressing and holding the F key will advance the paper (see pg. 7-5). Reloading the paper is allowed in this mode.
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. 1 1 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. * 3044 Sensor, Reusable, Finger * 3444 Sensor, Reusable, Finger 1 3311 Cable, Oximetry, 5 Feet (1.
Chapter 6: Trend Data Chapter 6: Trend Data Description Whenever the monitor is on, it stores one SpO2 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. A summary of trend data can be printed on the built-in printer or stored data can be downloaded to a computer.
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. The monitor must be in the Trend Printing Mode. 2. The Trend Printing Mode will be entered after the monitor is powered down in the Data Collection Mode or when the trend memory becomes full. 3.
Chapter 7: Printer • • • SpO2 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.1 Statistics - The statistics section contains information calculated from the valid data only. The following information is supplied in the statistics section: • % Time per SpO2 range – This section displays the percent of the valid sample time that the readings were in a specified range.
Chapter 7: Printer Figure 7.
Chapter 7: Printer Trend Printouts Collecting Trend Data Whenever the monitor is on, it stores one SpO2 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. Trend data will be preserved for about one and a half minutes, without battery power, allowing battery replacement without losing trend data. Trend memory will contain data for only one patient.
Chapter 8: PC Communication Setup Chapter 8: PC Communication Setup 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. The following items will be needed: 1. Printer Adapter Cable (Catalog No. 3350) 2. DB-9 Modem Cable (Catalog No.
Chapter 9: Maintenance Chapter 9: Maintenance Schedule of Maintenance MAINTENANCE: HOW OFTEN: BY DOING THIS: Replace battery When Low Battery Indicator is flashing or 12-15 hours of battery use has elapsed. Follow the instructions for installing the batteries. Disinfect the reusable sensor Before attaching the sensor to the patient. Follow the instructions for cleaning the reusable sensor. Disinfect the monitor When necessary. 1. Remove the batteries from the unit.
Chapter 10: Troubleshooting Chapter 10: Troubleshooting Problem Possible Cause Corrective Action Patient cable or sensor is disconnected from the oximeter. Check sensor connections to the patient cable and to the oximeter. Sensor is incorrectly positioned on the patient. Reposition the sensor. Poor patient perfusion. Reposition the sensor. Defective sensor or patient cable. Try a new sensor or contact your authorized repair center for help. Monitor is in the Data Collection or Trend Print Mode.
Chapter 10: Troubleshooting EMI Interference 2 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.
Chapter 11: Ordering Supplies & Accessories Chapter 11: Optional Supplies & Accessories Cat. No Description Quantity 1300 Sensor, Oximetry, Disp., Adult Finger 10/box 1301 Sensor, Oximetry, Disp., Ped. Finger, 15-45 Kg 10/box 1302 Sensor, Oximetry, Disp., Neonate, < 3 Kg 10/box 1303 Sensor, Oximetry, Disp., Infant, 3-15 Kg 10/box 1606HH Simulator & Cable , Oximeter, 5 ft.
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 Liquids: IPX1, drip proof Degree of Mobility: Portable Degree of Protection Against Electric Shock: Type BF Safety Requirements: EN60601-1: 1990 Displays, Indicators, & Keys SpO2: LED numeric display, 0.43 inches (10.9 mm) high Pulse Rate: LED numeric display, 0.43 inches (10.
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” alkaline cells (IEC Type LR6) Battery Life Alkaline Cells: 2 sleep screening cycles (1 cycle = 10 minutes with display on, 8 hours with display off, 5 minutes print
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 (clearto-send) line from the receiving device to the oximeter can be used to control data flow. After data pack has been sent, data communications stop, and can be resumed by cycling the power of the oximeter.
Appendix A: Data Format The following table shows an example of data de-compression: Byte in HEX De-compression 88 Marker byte, expect the next byte to be SpO2; 60 SpO2 value, HEX 60 equals to 96% SpO2 decimal, expect the next byte to be Pulse Rate; 52 Pulse Rate, HEX 52 equals to 82 bpm decimal, expect the next byte to be the byte divided into low and high nibbles; f0 Low nibble is 0, SpO2 = 96% + 0 = 96%; High nibble is –1, Pulse Rate = 82bpm – 1 = 81 bpm; ef Low nibble is -1, SpO2 = 96% - 1 =
A Smiths Medical – a part of Smiths Group plc C 0473 Authorized Representative (as defined by the Medical Device Directive): Graseby Medical Ltd.
