Summary of Contents for Smiths Medical BCI SPECTRO2 10
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BCI SPECTRO2 10 Handheld PulseOx Manual Get an original copy of the BCI SPECTRO2 10 Handheld PulseOx Manual for manufacturer information about service, available accessories and how to use and maintain your device.
Table of Contents Table of Contents Warranty and 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 ..................................
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Table of Contents Cleaning or Disinfecting the Sensors ......................4-11 Checking the Sensor and Oximetry Cable....................4-11 Pulse Amplitude Index ............................4-12 Storing the Sensor ..............................4-14 Home Use ................................4-15 Equipment and Supplies Checklist for Home Use ................4-15 Training the Home Use Caregiver ......................4-16 Chapter 5: Patient Record Number and Trend Data........
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The serial autocorrelation technology (SAC) in the WW1020 oximeter is covered by U.S. Patent No. 5,558,096. BCI, Comfort Clip, SPECTRO 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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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.
Chapter 1: Introduction Chapter 1: Introduction About the Manual The Clinician’s Operation Manual provides installation, operation, and maintenance instructions for the health-care professional 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 monitor.
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If purchased before that date, they may also be sent for recycling if being Separately replaced on a one-for-one, like-for-like basis (this varies depending on the country). Recycling instructions to customers using Smiths Medical products are published on the internet at: http://www.smiths-medical.com/recycle...
Chapter 1: Introduction kEYWORD DEFINITION WARNING Something that could hurt the patient or hurt the operator. CAUTION Something that could damage the monitor. NOTE Other important information. Warnings WARNING! This device is not intended for continuous patient monitoring. This device is intended to measure the patient’s %SpO and pulse rate values.
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Chapter 1: Introduction WARNING! Incorrectly applied sensors may give inaccurate readings. Refer to the sensor insert for proper application instructions. WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid. This may cause damage to the sensor which may cause inaccurate readings. WARNING! Unplug the sensor from the oximeter before cleaning or disinfecting to prevent damaging the sensor or monitor, and to prevent user safety hazards.
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Chapter 1: Introduction WARNING! IEC 60950 approved equipment must be placed outside the “patient environment.” The patient environment is defined as an area 1.5 m (4.92 feet) from the patient. Figure 1-1: Patient Environment WARNING! The oximeter will not operate without batteries installed. Properly charged batteries provide a reserve source of power in case of external power failure.
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The monitor’s AC rating is shown on the external power supply. If the rating is not correct, do not use the monitor. Contact the Smiths Medical PM, Inc. service department, or your authorized service representative, for help.
Chapter 1: Introduction Cautions CAUTION! Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. CAUTION! Do not disassemble unit, not user serviceable. Refer to qualified service personnel. CAUTION! Failure to charge the monitor while the monitor is in long term storage may shorten the battery life.
Chapter 1: Introduction Notes NOTE: The WW1090 rechargeable battery pack utilizes circuitry that optimizes the charging of the batteries. New packs will require multiple charge / discharge learning cycles before optimum performance is obtained. NOTE: “SpO averaging” means the number of pulse beats over which the SpO value is averaged;...
Chapter 2: Intended Use and Monitor Features Chapter 2: Intended Use and Monitor Features Intended Use for the WW1020 Oximeter The WW1020 pulse oximeter is intended for spot-checking applications (non continuous use). It monitors and displays patient’s functional oxygen saturation (%SpO ), pulse rate ), pulse signal strength, and Pulse amplitude Index (PI) readings.
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.
Chapter 2: Intended Use and Monitor Features Pulse Amplitude Index The PI value is a relative measure of pulse-signal strength over time at a pulse oximeter monitoring site, and is non-pulsatile in nature. Pulse amplitude Index is defined as PI = (100 × AC)/DC where AC is the alternating current (pulsatile component of the signal) and DC is direct current (non-pulsatile component of the signal).
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Chapter 3: Controls and Features Chapter 3: Controls and Features Front Display The display shows the measurements for SpO and Pulse Rate. It also shows a pulse strength indicator, a pulse amplitude indicator and indicators for AC power and battery charge level. Figure 3-1: Front Display Pulse Amplitude Index Bar Graph - green / yellow The Pulse amplitude Index bar graph is used to assist the operator in locating the oximetry...
Chapter 3: Controls and Features Monitor Operating key Figure 3-2: Monitor Operating Key ON/OFF key Momentarily press this key when the device is OFF to turn the monitor ON. Press this key when the device is ON to turn the monitor OFF. Press and hold this key when the device is OFF to clear the patient trend data.
Chapter 3: Controls and Features Monitor Back and Bottom Panels Figure 3-3: Monitor Back and Bottom Panels Sensor / RS232 Connector The sensor or an extension cable attaches here. With the sensor removed, trend data can be downloaded from this connector using an RS232 serial interface cable. See Chapter 7: Connecting to a PC for details.
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Chapter 4: Operating Instructions Chapter 4: Operating Instructions Unpacking the Monitor The following items are shipped with the oximeter: • Three (3) sensor cradles (WW1080) • Oximetry Sensor • Four (4) “AA” (LR6) alkaline batteries • Operation manual • Service manual (CD) Carefully remove the monitor and its accessories from the shipping carton.
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Chapter 4: Operating Instructions After connecting to power, verify that the green External Power Indicator is lit. External Power Battery Charge Indicator Indicator Figure 4-1: External Power/Charge Indicators If an AC source is present, the oximeter will draw power from it first. While the oximeter is operating from an AC source, the External Power Indicator ( ) will illuminate.
Chapter 4: Operating Instructions Installing the Batteries The oximeter uses four (4) standard “AA” alkaline, IEC Type LR6, cells (Figure 4-2A) or a custom rechargeable Lithium-Ion (Li+) battery pack (WW1090 - Figure 4-2B). WARNING! Inspect battery terminals for corrosion or contamination. The monitor may not operate properly if battery terminals are corroded or contaminated.
WARNING! Patient safety can be compromised by the use of a power supply not supplied by Smiths Medical PM, Inc. Use only the power supply included with your monitor, or one approved by Smiths Medical PM, Inc. WARNING! Ensure the device’s AC rating is correct for the AC voltage at your installation site before using this monitor.
Chapter 4: Operating Instructions AC Power The AC power supply can plug into the oximeter (Figure 4-3) or into the WW1089 USB interface cable (Figure 4-4). Power Input Connector AC Power Supply Figure 4-3: AC Power Supply AC Power Supply (Optional) Connect AC Power Power Input...
Chapter 4: Operating Instructions USB Power (Universal Serial Bus) AC Power Supply (Optional) Connect AC Power Power Input Here (Optional) Connector USB Interface Cable to PC USB Interface Cable Connect USB Cable to Monitor Figure 4-5: USB Power to Oximeter The oximeter may be powered from an external USB source such as a laptop computer or powered USB hub.
Chapter 4: Operating Instructions Turning On the Monitor Press this key to turn the monitor on and off. Figure 4-6: Turning On the Monitor To turn on the monitor, press the key. Before using the monitor, check the following at power- •...
Pulse oximeters do not require user calibration. If checking the function of the device is desired, an Oximetry Patient Simulator (Smiths Medical PM, Inc. catalog number 1606) is available as an accessory. The simulator attaches to the oximeter in place of the sensor. It provides a known SpO and pulse rate signal to the oximeter.
Chapter 4: Operating Instructions Attaching the Sensor to the Patient To attach the sensor to the patient: Choose the appropriate sensor. See sensor table for additional information. If using a reusable sensor, clean or disinfect the sensor per Cleaning or Disinfecting the Sensors section in this chapter.
Chapter 4: Operating Instructions Choosing the Sensor WARNING! Use only SpO sensors and cables supplied with, or specifically intended for use with, this oximeter. Use of sensors not intended for use with this device may cause inaccurate readings. WARNING! Incorrectly applied sensors may give inaccurate readings. Refer to the sensor insert for proper application instructions.
Chapter 4: Operating Instructions Nellcor® Sensor (WW1020 Only) PATIENT SITE DESCRIPTION Adult Finger DS100A finger sensor (reusable) over 45 kg Cleaning or Disinfecting the Sensors Clean or disinfect reusable sensors before attaching to a new patient. WARNING! Unplug the sensor from the monitor before cleaning or disinfecting. WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid.
Chapter 4: Operating Instructions Hold the connector rather than the cable when connecting or disconnecting the finger sensor to the device. Figure 4-7: Disconnecting or Connecting the Finger Sensor to the Device Do not use excessive force or unnecessary twisting when connecting, disconnecting, storing, or when using the sensor.
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Chapter 4: Operating Instructions When placing the sensor on the patient, allow the cable to lay across the top of the hand and parallel to the arm of the patient as shown in Figure 4-8. Figure 4-8: Positioning the Cable of the Finger Sensor Sensor (finger sensor shown for illustration only) Cable Clinician’s Operation Manual...
Chapter 4: Operating Instructions Storing the Sensor Upon completion of patient monitoring, detach the sensor and loosely coil the finger sensor cable. Store the sensor in the Sensor Storage cradle or other safe place when not in use. Use the proper cradle.
Chapter 4: Operating Instructions Home Use 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 before using the device.
Chapter 4: Operating Instructions Training the Home Use Caregiver The home use caregiver must be trained in CPR. Inform the caregiver that the oximeter is not to be used as an apnea monitor and should only be used for spot checking applications (non- continuous use).
Chapter 5: Patient Record Number and Trend Data Chapter 5: Patient Record Number and Trend Data Description Whenever the WW1000/WW1020 is monitoring a patient, it stores an SpO , a pulse rate, and PI reading along with any applicable condition flags and a time stamp every four (4) seconds. The stored readings are called trend data.
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Chapter 6: Optional Docking Station and Printer Chapter 6: Optional Docking Station and Printer Description Figure 6-1: Docking Station with Printer Attached The WW1025 Docking Station serves many purposes depending on individual needs and selection of optional equipment. The Docking Station is powered by the WW1095 AC Power Supply, which can power the oximeter and operate the printer while charging the internal and spare battery packs.
Chapter 6: Optional Docking Station and Printer Docking Station Figure 6-2: Indicators on Docking Station Front Panel AC Power Indicator This indicator will light when AC power is connected to the Docking Station. USB Power Indicator This indicator will light when a USB cable is connected to the Docking Station, but AC power is not.
Chapter 6: Optional Docking Station and Printer NOTE! To slow charge the WW1090 Lithium-Ion (Li+) Rechargeable Battery Pack, install the Battery Pack in the oximeter and connect to USB power. Slow charging may take 20 hours or more. USB power cannot charge the spare Li+ Rechargeable Battery Pack in the Docking Station.
Chapter 6: Optional Docking Station and Printer Printer Figure 6-4: Printer Keys and Indicators Print Mode Indicators These indicators light according to what print mode is selected. See Choosing the Print Mode section later in this Chapter. The Print Mode Indicator will blink green when printing is pending or in progress. Start/Stop Print key Press this key to start or stop printing.
Chapter 6: Optional Docking Station and Printer Attaching the Printer The optional WW1026 thermal printer attaches to the Docking Station with a single screw as shown in Figure 6-5C. Follow the steps below. WARNING! The Docking Station must have a Printer or Printer Port Cover installed. Failure to do so may cause a risk of electrical shock to the patient or operator or risk damage to the equipment.
Chapter 6: Optional Docking Station and Printer Loading Paper The printer uses 58mm wide thermal paper. See Chapter 10: Optional Supplies & Accessories for part number and ordering information. To load the paper, follow the steps illustrated below. Release printer door by lifting clear cover. Lift here Figure 6-6A: Release Printer Door Swing open paper holder by...
Chapter 6: Optional Docking Station and Printer Choosing the Print Mode Data can be printed in real time, numeric trend or graphic trend modes. In either trend mode, 6 days of previously stored data (depending on trend interval) collected from 1 to 99 patients can be printed.
Chapter 6: Optional Docking Station and Printer Mode - Graphic Trend Mode prints in a chart format See figure 6-9. TREND DATA ID: 009______________________ Trend Time Scale=20 Sec/Point ...... Pulse Rate(bpm) ► ► ► ► ► ► ► ► ► ► SpO2(%) ▪...
Chapter 7: PC Communication Setup Chapter 7: PC Communication Setup Description Real Time and Trend Data may be sent to a PC from the oximeter in the following ways: • The Data/Power Connector of the oximeter or of the Docking Station may be connected to a PC using the USB Interface Cable ( <...
Chapter 7: PC Communication Setup Power Input and Data Connector Port Data can be transferred to a computer running software that is compatible with the specialized data format BCICP1030 by using the USB Interface Cable. The following items will be needed: •...
Chapter 7: PC Communication Setup How to Set Up Equipment Refer to Figure 7-2 for the cable connections. AC Power Supply (Optional) Connect AC Power Here (Optional) Power Input Connector USB Interface Cable to PC USB Interface Cable Connect USB Cable to Monitor Figure 7-2: Connecting to a PC using USB Interface Cable Connect the USB interface cable to the I / O or Power Input Connector on the oximeter or...
Chapter 7: PC Communication Setup Sensor / RS232 Port Trend data may be downloaded in a comma-separated value (.CSV) format to a computer’s serial (RS232) port. The following items will be needed: • Oximeter • HyperTerminal or other PC communication software •...
Chapter 7: PC Communication Setup Output Format Trend data is transmitted in the format shown in Figure 7-4. TREND DATA ID:009__________________ hh:mm:ss SpO2 Rate (bpm) 00:55:08 00:55:04 83 bpm 1.6% 00:54:56 84 bpm 2.8% 00:54:52 83 bpm 2.6% 00:54:48 84 bpm 3.2% 00:54:44 84 bpm 3.6% 00:54:40...
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Chapter 8: Maintenance Chapter 8: Maintenance Smiths Medical PM, Inc. products have been designed to operate continuously. However, in order to ensure a continued high level of performance and safety of operation, routine maintenance must be performed daily. < The Oximeter Service Manual ( WW1923) also contains the circuit diagrams, parts lists, and descriptions required for carrying out repairs.
Chapter 8: Maintenance Cleaning and Disinfecting WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the monitor in liquid. Clean the surfaces of the monitor with a soft cloth moistened in water or a mild soap solution. If disinfecting is necessary, wipe the surfaces of the monitor with a 70% isopropyl alcohol solution. If there is contamination with blood borne pathogens or other potentially infectious materials, then the use of an approved disinfectant of appropriate spectrum for the suspected organisms is appropriate.
Chapter 9: Troubleshooting Chapter 9: Troubleshooting WARNING! If the accuracy of any measurement is in question, check the patient’s vital signs by an alternative method, and then check the monitor for proper functioning. Power PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION The oximeter doesn’t Batteries weak and/ or no AC Replace or recharge the batteries.
Chapter 9: Troubleshooting PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION The monitor displays The battery is defective. Disconnect the AC power cord and then reconnect it. If the error message when persists, the battery is defective. powered up. Contact your authorized service representative.
Chapter 9: Troubleshooting Other PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION No printout on AC power is not connected to Connect AC Power to the Docking optional printer. the Docking Station. Station. No trends in memory. Take trend data. No paper or paper incorrectly See Chapter 6: Optional Docking loaded.
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Chapter 10: Optional Supplies and Accessories Chapter 10: Optional Supplies and Accessories CAT. NO. DESCRIPTION QTY. WW1000 each Pulse Oximeter WW1018R each Protective glove - red WW1018Y each Protective glove - yellow WW1018G each Protective glove - green WW1018B each Protective glove - blue WW1020 Pulse Oximeter (with Serial Autocorrelation)
Ordering Information Outside the USA, for ordering information, contact your local distributor. In the USA, for ordering information, contact the customer service department at the address or phone number below: Smiths Medical PM, Inc. Phone: (262) 542-3100 N7W22025 Johnson Drive...
Chapter 11: Specifications Chapter 11: Specifications Displays 2-digit LED display, 19 mm high. Pulse Rate: 3-digit LED display, 12.7 mm high. 9-segment LED bar graph. Pulse Signal Strength: Logarithmically scaled 9-segment LED bar graph. Display update rate and Pulse rate: 2Hz All other data: 10Hz Display Refresh: 50 Hz...
Chapter 11: Specifications for the WW1020 Oximeter 0-100% Functional Saturation (Display Maximum: 99%) Range: Resolution: 1 count (%SpO 8 beats Averaging: Calibration: Factory calibrated over range 70% to 100% SpO using human blood samples to functional saturation. Test methods are available upon request. No in-service calibration is required.
Chapter 11: Specifications for the WW1000 Oximeter Range: 0-99% Functional Saturation Resolution: 1 count (%SpO Averaging: 8 beats Calibration: Factory calibrated over range 70% to 99% SpO using human blood samples to functional saturation. Test methods are available upon request. No in- service calibration is required.
Chapter 11: Specifications Pulse Amplitude Index for the WW1020 Oximeter Range: 0.03% to 20.00% (0.01% increments) Pulse amplitude Index is defined as PI = (100 × AC)/DC where AC is the alternating current (pulsatile component of the signal) and DC is direct current (non-pulsatile component of the signal).
Chapter 11: Specifications Serial Data Output Power Input and Data Connector Data transferred through this connector is in a proprietary BCICP1030 format. Format available upon request. Sensor Connector Data Type: ASCII comma delimited string output at 1 Hz. Lines terminated with a carriage return.
Chapter 11: Specifications Equipment Classification Type of Protection Against Electric shock: Class II or Internally Powered Mode of operation: Spot Check (non-continuous) Degree of Protection Against ingress of Liquids: IPX2, drip proof Degree of Mobility: Portable Degree of Protection Against Electric Shock: Type BF Electromagnetic classification:...
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Appendix A: Guidance and Manufacturer’s Declaration Appendix A: Guidance and Manufacturer’s Declaration Guidance and Manufacturer’s Declaration The WW1000/WW1020 pulse oximeter is intended for use in the electromagnetic environment specified in the tables within this appendix. NOTE! The WW1000/WW1020 pulse oximeter system must be put into service according to the provided EMC information to ensure proper operation.
Appendix A: Guidance and Manufacturer’s Declaration Electromagnetic Immunity - Immunity Test GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The WW1000/WW1020 pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or end user of the WW1000/WW1020 pulse oximeter should ensure that it is used in such an environment.
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Appendix A: Guidance and Manufacturer’s Declaration GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The WW1000/WW1020 pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or end user of the WW1000/WW1020 pulse oximeter should ensure that it is used in such an environment. IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC...
Appendix A: Guidance and Manufacturer’s Declaration Recommended Separation Distances RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE WW1000/WW1020 PULSE OXIMETER The WW1000/WW1020 pulse oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the WW1000/ WW1020 pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the WW1000/WW1020 pulse oximeter as recommended below, according to the maximum...
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Appendix A: Guidance and Manufacturer’s Declaration The following is a list of cables, transducers and accessories used with the WW1000/WW1020 pulse oximeter. WARNING! Use of accessories, transducers and cables other than those specified below may result in increased emissions or decreased immunity of the systems. BCI®...
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Phone: (44) 1923 246434 Colonial Way, Watford, Hertfordshire, Fax: (44) 1923 240273 WD24 4LG, UK Australian Representative: Smiths Medical Australasia Pty. Ltd. Tel: +61 (0) 7 3340 1300 61 Brandl Street, Eight Mile Plains, QLD 4113, Australia MEDICAL EQUIPMENT Manufactured By...
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