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Updated the Smiths logo to include a ® symbol. Smiths and BCI and Comfort Clip are trademarks of the Smiths Medical family of companies. Microfoam is a trademark of the 3M Company. The symbol ® indicates the trademark is registered in the U.S.
Table of Contents Table of Contents Chapter 1: Introduction................1-1 Proprietary Notice ..................1-1 Warranty ......................1-1 Limited Warranty ..................1-1 Disclaimer of Warranties ..............1-1 Conditions of Warranty ................ 1-2 Limitation of Remedies................. 1-2 Warranty Procedure................1-3 CE Notice ......................1-3 Definition of Symbols..................
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Table of Contents Chapter 5: Changing the Monitor’s Settings ........5-1 Silencing Alarm and Alert Tones............... 5-1 Changing the Alarm and Alert Tone Volume ........5-1 Changing the Brightness of the Display ..........5-1 Changing the Pulse Beep Volume............5-2 Changing the Alarm Limits .................
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Table of Contents Chapter 10: Maintenance ..............10-1 Schedule of Maintenance................10-1 Correcting the SENSOR Alert..............10-2 Chapter 11: Troubleshooting...............11-1 Chapter 12: Optional Supplies and Accessories......12-1 Ordering Information..................12-2 Chapter 13: Specifications..............13-1 Oximeter ......................13-1 Oximeter Clinician’s Operation Manual...
Information contained in this document is copyrighted by Smiths Medi- cal PM, Inc. and may not be duplicated in full or part by any person with- out 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 Seller disclaims responsibility of the suitability of the Product for any par- ticular medical treatment or for any medical complications resulting from the use of the Product. This disclaimer is dictated by the many ele- ments which are beyond Seller’s control, such as diagnosis of patient, conditions under which the Product may be used, handling of the Prod- uct after it leaves Seller’s possession, execution of recommended instructions for use and others.
Box and inserts should be in original condition. If original ship- ping material in good condition is not available, it should be purchased from Smiths Medical PM, Inc. Damages occurred in transit in other than original shipping containers are the responsibility of the shipper. All costs incurred returning devices for repair are the responsibility of the shipper.
Chapter 1: Introduction Definition of Symbols Symbol Definition Type B equipment Attention, consult accompanying documents Refer servicing to qualified service personnel Alarm Silence Non AP Device ID Clear Up and Down Keys Alarm Volume Pulse Volume Use By Catalog Number Date of Manufacture Serial Number Moisture Sensitive...
Chapter 1: Introduction Warnings, Cautions, and Notes Keyword Definition Tells you about something that could hurt the WARNING! patient or hurt the operator CAUTION! Tells you about something that could damage the monitor NOTE! Tells you other important information WARNING! These instructions contain important information for safe use of the product.
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RF emissions. 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.
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Chapter 1: Introduction WARNING! IEC 950 approved equipment must be placed out- side of the patient environment. The patient environment is defined as an area 1.5 m (4.92 feet) from the patient. Example of the patient environment. The dimensions are not prescriptive.
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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 local dis- tributor for help. CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid.
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Chapter 1: Introduction NOTE! Operation of this device may be adversely affected in the presence of strong electromagnetic sources, such as elec- trosurgery equipment. NOTE! Operation of this device may be adversely affected in the presence of computed tomography (CT) equipment. NOTE! Use only SpO sensors supplied with, or specifically intended for use with, this device...
Chapter 2: Monitor Features Chapter 2: Monitor Features About the Manuals The Clinician’s Operation Manual provides installation, operation, and maintenance instructions for the health-care professional trained in monitoring respiratory and cardiovascular activity. The Home-Use Instruction Book provides operation and maintenance instructions for the home-use caregiver.
Chapter 2: Monitor Features Intended Use The Oximeter provides fast, reliable SpO , pulse rate, and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport, or for in-home use. The oximeter will operate accurately over an ambient temperature range of 32 to 104°...
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Chapter 2: Monitor Features • Low battery indicator lights when about 30 minutes of battery use remains. • Connects to an optional external printer. Prints less than 15 minutes of trend data in a tabular format, or more than 15 minutes of trend data in a graphic format.
Chapter 3: Controls Chapter 3: Controls Sensor/ Printer Connector SpO2 Numeric Display Pulse Rate Numeric Display Power Supply Connector Figure 3-1: Front Panel 1. Sensor /Printer Connector The sensor connects here, or an oximetry cable can be connected between the monitor and the sensor. The printer is also connected here. 2.
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Chapter 3: Controls Pulse Strength Bar Graph Sensor Light BATT Light Figure 3-2: Front Panel 5. Pulse Strength Bar Graph The pulse strength bar graph “sweeps” with the patient’s pulse beat. The height of the bar graph tells the strength of the patient’s pulse. 6.
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Chapter 3: Controls Alarm Silenced Light POWER Light CHGING Light Figure 3-3: Front Panel Alarm Silenced Light The alarm silenced light flashes on and off when the alarm and alert tones are silenced for two minutes. The alarm silenced light remains on when the alarm and alert tones are silenced indefinitely (until canceled or until the monitor is turned off ).
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Chapter 3: Controls ON Key OFF/STBY I.D./CLEAR Figure 3-4: Front Panel 11. ON Key Pressing ON turns on the monitor. 12. OFF/STBY Key Pressing OFF/STBY turns off the monitor. 13. I.D./CLEAR Key While the sensor is connected to the monitor: Pressing I.D./CLEAR increases the patient number by one;...
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Chapter 3: Controls Up Arrow ) Key ALARM SEL Down Arrow ) Key Figure 3-5: Front Panel Keys keys are used to adjust up and down the following set- tings: brightness of the display; alarm limits; trend view patient num- bers;...
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Chapter 3: Controls Alarm Silence ALARM VOL PULSE VOL Key Figure 3-6: Front Panel Alarm Silence Key Momentarily pressing the Alarm Silence key silences the alarm tone for two minutes. Pressing and holding the alarm silence key for about three seconds silences the alarm tone indefinitely (until canceled or until the monitor is turned off ).
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Chapter 3: Controls Sensor /Printer Connector Power Supply Figure 3-7: Front Panel 19. Sensor /Printer Connector An optional printer can be connected for printing trend data. See Printer section for more printer options. 20. AC Power Supply AC power supply connects here. Oximeter Clinician’s Operation Manual...
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 local dis- tributor, for help. Refer also to chapter 12, Optional Supplies and Accessories to verify the proper AC power supply for your application.
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 local dis- tributor for help. 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...
Chapter 4: Operating Instructions Care and Handling of the Sensor WARNING! Misuse or improper handling of the sensor and cable could result in damaging of the sensor. This may cause inaccurate readings. Hold the connector rather than the cable when connecting or discon- necting the finger sensor to the device as shown in Figure 4.1.
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Chapter 4: Operating Instructions 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 Fig- ure 4.2. Sensor Cable Figure 4-2: Finger Sensor Upon completion of patient monitoring, detach the sensor as shown in Figure 4.1 and loosely coil the finger sensor 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 are working properly. WARNING! Using a damaged sensor may cause inaccurate readings.
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Chapter 4: Operating Instructions Latch Oximetry Cable Connectors Sensor Figure 4-3: Attaching the Sensor and Oximetry Cable to the Monitor 3. If using the oximetry cable: a. If the sensor is not already connected to the oximetry cable, connect the sensor to the oximetry cable as shown. Push the connectors together firmly and close the latch to secure the connectors.
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Chapter 4: Operating Instructions Figure 4-4: Attaching the Sensor to the Monitor 4. If not using the oximetry cable: Connect the sensor to the monitor as shown. Push the connector firmly into the monitor. 5. If the monitor is not already on, press the ON key to turn on the mon- itor.
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Chapter 4: Operating Instructions 6. Before the sensor is attached to the patient, check the integrity of the sensor, oximetry cable, and oximeter as follows: WARNING! If any of the integrity checks fail, do not attempt to monitor the patient. Use another sensor or oximetry cable, or contact the equipment dealer for help if necessary.
Chapter 4: Operating Instructions • For “Y” sensors, wrap sensors, and disposable sensors: Align the sensor’s red light with the detector so they are less than 1/8 inch away from each other. Make sure the SENSOR indicator is flash- ing on the oximeter. •...
Chapter 4: Operating Instructions Turning On the Monitor To turn on the monitor: 1. Press the ON key. When turned on, the monitor does the following: • The pulse strength bar graph segments light one at a time. • The monitor's software revision is momentarily displayed. •...
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Chapter 4: Operating Instructions 3. The monitor has available three averaging settings for SpO pulse. To change the averaging setting, press and hold the arrow key while turning on the monitor. While holding the key, press the key to scroll through the following averaging selections: PULSE AVERAGING AVERAGING...
Chapter 4: Operating Instructions Alarms Alarms warn you about an abnormal patient condition. An alarm turns on when: • the patient’s SpO reading matches or exceeds the SpO alarm range, or • the patient’s pulse rate reading matches or exceeds the pulse rate alarm range.
Chapter 4: Operating Instructions Alerts An alert warns you about an abnormal monitor condition. An alert turns on when: • the sensor is not connected to the monitor, or • the sensor is not attached to the patient, or • the sensor is not properly attached to the patient.
Chapter 4: Operating Instructions BATT Attention BATT flashes on and off dur- ing a BATT Attention Figure 4-10: BATT Attention Example During the BATT attention: • a short burst of beeps sounds every 30 seconds. • the BATT light flashes on and off. WARNING! When BATT flashes, you must immediately charge the monitor’s battery.
Checking the Monitor’s Performance Pulse oximeters do not require user calibration. If checking the function of the device is desired, an optional Oximeter/ECG Patient Simulator (Smiths Medical PM catalog number 1606) is available as an accessory. The simulator attaches to the oximeter in place of the sensor or oximetry cable.
Chapter 5: Changing the Monitor’s Settings Chapter 5: Changing the Monitor’s Settings Silencing Alarm and Alert Tones The alarm and alert tones can be silenced for two minutes or indefinitely (until canceled or until the monitor is turned off ). 1.
Chapter 5: Changing the Monitor’s Settings Changing the Pulse Beep Volume A “beep” tone sounds with each pulse beat. The volume of the “beep” can be positioned to three settings: soft, loud, and off. To adjust the vol- ume to the ‘off’ setting, push the PULSE VOL key once. From the ‘off’ set- ting, set the volume to ‘soft’...
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Chapter 5: Changing the Monitor’s Settings NOTE! “ – – – ” in the display means the limit is set to off. NOTE! Alarm limits are non-overlapping. You cannot set the high alarm equal to or lower than the low alarm and you can- not set the low alarm equal to or higher than the high alarm.
Chapter 6: Patient Numbers and Trend Data Chapter 6: Patient Numbers and Trend Data Description Whenever the monitor is on, it stores one SpO and one pulse rate reading every thirty (30) seconds. The stored readings are called trend data. The monitor remembers trend data for up to 99 patients and 24 hours of run-time.
Chapter 6: Patient Numbers and Trend Data a. The middle two pulse bars flash., indicating the monitor is in “trend view” mode. The two pulse bars continue to flash until the mode is exited. b. The current patient number is shown for a few seconds. c.
Chapter 7: Printer Chapter 7: Printer Description AC Power Optional Printer Printer Connector Figure 7-1: Setting Up the Oximeter and the Printer Data can be printed in trend data mode. In this mode up to 24 hours of previously stored data, collected from 1 to 99 patients, is printed. Whenever the monitor is on, it stores one SpO and pulse rate reading every thirty (30) seconds.
Chapter 7: Printer The monitor remembers trend data for up to 99 patients and 24 hours of run-time. The trend data can be printed at any time on the optional printer. Selecting Print Mode For Trend Data 1. Keep the ALARM SEL key pressed for 5 seconds.
Chapter 7: Printer Compatible Printers Printer requirements: FUNCTION SPECIFICATION I/O Port Serial RS-232C Data Type ASCII Data Format 9600 baud, 1 start bit, 8 data bits, 1 stop bit, no parity I/O Connector Standard DB-9 Graphics Interface Seiko Printer Graphics Interface Compatible Printers: MANUFACTURER MODEL NUMBER...
Chapter 7: Printer Setting Up the Monitor and the Printer Printer Cable Sensor Con- nector To AC Power Printer DB-9 Null Modem Cable DB-9 Printer Connector Figure 7-3: Setting Up the Oximeter and the Printer 1. Refer to the printer’s operation manual and make sure the printer’s RS-232 data format is set up as follows: •...
Chapter 7: Printer Trend Printouts Collecting Trend Data Whenever the monitor is on, it stores one SpO and one pulse rate read- ing every thirty (30) seconds. The stored readings are called trend data. The monitor remembers trend data for up to 99 patients and 24 hours of run-time.
Chapter 7: Printer Printing Trend Data 1. Set up the monitor and printer as previ- ously described. 2. Disconnect the SpO sensor from the monitor. 3. Connect the printer cable to the monitor. 4. Turn on the printer. 5. Turn on the monitor. The monitor prints the trend data for each patient, from patients 1-99, as shown in the sample printout.
Chapter 8: Operating Modes Chapter 8: Operating Modes About the Monitor’s Operating Modes The monitor has three operating modes: clinician mode (previously described), home-use mode and sleep study mode. • The clinician mode is intended for health-care professionals trained in monitoring respiratory and cardiovascular activity. •...
Chapter 8: Operating Modes Setting Up the Monitor for Home-Use 1. Set the high and low alarm limits for SpO and pulse rate to the val- ues prescribed by the doctor: • High SpO alarm limit. • Low SpO alarm limit. •...
Chapter 8: Operating Modes Equipment and Supplies Checklist for Home-Use Provide the following to the home-use caregiver: QUANTITY CAT. NO. DESCRIPTION 3303 Oximeter 8210 AC Adapter, 105-125V 60Hz 8212 AC Adapter, 230V 50/60Hz 8216 AC Adapter, 100V 50Hz Protective rubber boot with 3353 carrying case 3049...
Chapter 8: Operating Modes The home-use caregiver will also need these supplies and reference materials: QUANTITY DESCRIPTION Scissors (for trimming adhesive strips or adhesive tape). Isopropyl alcohol and a soft, clean cloth (or alco- hol wipes) for disinfecting monitor and reusable sensor.
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Chapter 8: Operating Modes • Visually inspect the sensor and oximetry cable. • Connect the sensor to the oximetry cable. • Connect the oximetry cable to the monitor. • Turn on the monitor. • Route the cable safely from the patient to the monitor to prevent possible patient strangulation.
Chapter 8: Operating Modes Turning Off Home-Use Mode 1. Turn off the home-use mode (put the monitor into the clinician mode) as follows: a. Turn off the monitor. b. Press and hold the PULSE VOL key, then press the ON key. c.
Chapter 8: Operating Modes Sleep Study Mode While the monitor is in sleep study mode: • Patient numbers and trend view are disabled. • A new trend block is started each time the monitor is turned on. • Trend data from the patient is stored and may then be output to a PC.
Chapter 8: Operating Modes • Trend data from the patient is stored every four seconds. The data consists of a minimum display value over the four sec- ond interval. Refer to the Turning on the Monitor section for infor- mation on SpO and pulse rate display values (specifically “averaging”).
Chapter 8: Operating Modes b. Turn on the monitor while observing the display; should be shown briefly when the monitor is turned on. If not, repeat step 1 above. Turning Off Sleep Study Mode 1. Turn off the sleep study mode (put the monitor into the clinician mode) as follows: a.
Chapter 8: Operating Modes PC Communication Setup Printer Cable Sensor Con- To AC Power nector DB-9 Null Modem Cable DB-9 Printer Connector Figure 8-1: Setting Up the Oximeter and the PC 1. Power up the monitor. 2. Connect the printer communication cable to the monitor. 3.
Chapter 8: Operating Modes Transferring Sleep Study Data to a PC 1. Set up the monitor, cables, and PC as previously described. 2. Turn on the PC and load the communication software, setting the serial communication defaults as previously described. 3.
Chapter 9: Charging the Monitor Chapter 9: Charging the Monitor AC Charger to Wall Outlet AC Charger to AC Power Connector Figure 9-1: Connecting AC Power 1. Connect the AC charger as shown. Refer to Chapter 12, Optional Supplies and Accessories, to verify the proper AC power supply for your application.
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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 local dis- tributor, for help. CAUTION! Monitors not in use must be fully charged at least every five months, otherwise the battery will no longer be able to accept a charge.
Chapter 10: Maintenance Chapter 10: Maintenance Schedule of Maintenance MAINTAIN THIS HOW OFTEN: BY DOING THIS: ITEM: When BATT is flashing, or after the monitor has been used under bat- tery power. Follow the instructions Battery Monitors in storage or for charging the monitor.
Chapter 10: Maintenance Correcting the SENSOR Alert Follow these steps to correct the sensor alert: 1. Make sure the sensor’s connector is firmly seated in the monitor’s connector. 2. Make sure the sensor is properly attached to the patient. See Attach- ing the Sensor to the Patient section for help.
Chapter 11: Troubleshooting Chapter 11: Troubleshooting PROBLEM: POSSIBLE CAUSE / SOLUTION: 1. Sensor may not be properly connected to monitor. Make sure sensor connector is firmly seated in monitor connector. 2. Sensor may not be properly attached to patient. See Attaching the Sensor to the SENSOR alert.
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Chapter 11: Troubleshooting Monitor turns off sud- Battery needs charging. See Charging the denly. Monitor. 1. Make sure the AC power supply is firmly connected to the wall outlet and to the mon- itor. 2. Make sure the wall outlet is not controlled POWER indicator does by a switch.
Chapter 12: Optional Supplies and Accessories Ordering Information For ordering information, contact your local distributor or the Smiths Medical PM, Inc. customer service department. Smiths Medical PM, Inc. Phone: 262 542 3100 N7 W22025 Johnson Drive Fax: 262 542 3325 Waukesha, WI 53186 USA Email Address: info@smiths-bci.com...
Chapter 13: Specifications Chapter 13: Specifications Oximeter Parameters Monitored Pulse Rate Pulse Strength 3-digit LED display, 0.43 inches Displays, Indicators, & Keys SpO (10.9 mm) high. 3-digit LED display, 0.375 inches Pulse Rate (9.5 mm) high. Pulse Logarithmically scaled 8-seg- Strength ment LED bar graph.
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Chapter 13: Specifications Pulse Rate Range 30-254 BPM Accuracy ±2% at 30-254 BPM High 250-5 BPM and off in 5 BPM steps. Alarm Limits Low 5-250 BPM and off in 5 BPM steps. Averaging 8 or 16 second average. Two-tone audible alarm with user-adjustable vol- Alarm Indicators ume and two-minute or indefinite alarm silence.
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Smiths Medical PM, Inc. Patient Monitoring and Ventilation 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 UK, WD24 4LG...
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