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Chapter 8: Specifications

Oximeter Operation and Service Manual

8-1

Chapter 8: Specifications

Equipment Classification

Displays, Indicators, & Keys

SpO

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

SpO

LED numeric display, 0.46 inches (11.68 mm) high

Pulse Rate:

LED numeric display, 0.38 inches (9.65 mm) high

Pulse Strength:

Logarithmically scaled 8-segment LED bar graph

Keys:

keys

Range:

0-99%

Accuracy:

±2% at 70-99%

Averaging:

8 pulse beat average

Display Response

The display is to functional saturation. The pulse
strength bar graph is not proportional to pulse vol-
ume.

Display Update
Rate

1 Hz (SpO

); 60 Hz (pulse strength)

Calibration

Factory calibrated over range 70% to 100% SpO

using human blood samples to functional saturation.
Test methods available upon request. No in-service
calibration required.

Sensors

Red 660nm, 2mW (typical)

Infrared 905nm, 2-2.4mW (typical)

Содержание 1818R

Страница 1: ...BCI PulseOx Handheld Manual Get an original copy of the BCI PulseOx Handheld Manual for manufacturer information about service available accessories and how to use and maintain your device ...

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Страница 4: ...tion 2 2 Theory of Operation 2 4 Chapter 3 Using the Oximeter 3 1 Install the Batteries 3 1 Installing or Replacing the Batteries 3 2 Care and Handling of Sensor 3 3 Choose the Sensor 3 4 Attach the Sensor to the Patient 3 5 Clean or Disinfect the Sensors 3 5 Finger Sensor for Adult or Pediatric Finger 3 5 Attach the Sensor to the Oximeter 3 6 Measuring the Patient s SpO2 and Pulse Rate 3 6 Patien...

Страница 5: ...k Data 4 4 Chapter 5 Operator s Maintenance 5 1 Batteries 5 1 Disposal of batteries and rechargeable batteries 5 1 Sensors 5 1 Reusable Sensors 5 1 Disposable Sensors 5 2 Cleaning the Oximeter s Surfaces 5 2 Long Term Storage 5 2 Chapter 6 Operator s Troubleshooting Chart 6 1 EMI Interference 6 3 Chapter 7 Optional Supplies and Accessories 7 1 Ordering Information 7 2 Chapter 8 Specifications 8 1 ...

Страница 6: ...eral Description 9 1 Power Supply and ON OFF Circuitry 9 1 Digital Section 9 1 Analog Section 9 3 LED Controller 9 4 Signal Dictionary 9 4 Test Equipment and Tools Required 9 6 Connecting a DC Power Supply 9 6 Voltage Test Points 9 7 Waveform Test Points 9 9 Appendix Assembly Drawings Schematics Parts Lists 1 ...

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Страница 8: ...val of Smiths Medical PM Inc Its purpose is to provide the user with adequately detailed documentation to efficiently install oper ate maintain and order spare parts for the device supplied Every effort has been made to keep the information contained in this document current and accurate as of the date of publication or revision However no guarantee is given or implied that the document is error f...

Страница 9: ...d instructions for use and others Conditions of Warranty This warranty is void if the Product has been altered misused damaged by neglect or accident not properly maintained or recharged or repaired by persons not authorized by Seller Misuse includes but is not limited to use not in compliance with the labeling or use with accessories not manufac tured by Seller This warranty does not cover normal...

Страница 10: ...e USA contact your local distributor Keep all original packing material including foam inserts If you need to ship the device use only the original packaging material including inserts Box and inserts should be in original condition If original shipping mate rial in good condition is not available it should be purchased from Smiths Medical PM Inc Damages occurred in transit in other than original ...

Страница 11: ...ice Manual Definition of Symbols SYMBOL DEFINITION 2 Attention consult accompanying documents r Type BF equipment 7 Refer servicing to qualified service personnel REF Catalog Number SN Serial number R On Q Off y Date of Manufacture 1 Non AP Device C Use by ...

Страница 12: ... 2 WARNING Prolonged use or the patient s condition may require changing the sensor site periodically Change sen sor site and check skin integrity circulatory status and correct alignment at least every 4 hours 2 WARNING When connecting this monitor to any instru ment verify proper operation before clinical use Refer to the instrument s user manual for full instructions Acces sory equipment connec...

Страница 13: ... 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 This device is intended for use by persons trained in professional health care The operator must be thoroughly familiar with the information in this manual before using the device Notice This device is not approved for home use by a non heal...

Страница 14: ...ing NOTE Any condition that restricts blood flow such as use of a blood pressure cuff or extremes in systemic vas cular resistance may cause an inability to determine accurate pulse rate and SpO2 readings NOTE Remove fingernail polish or false fingernails before applying SpO2 sensors Fingernail polish or false finger nails may cause inaccurate SpO2 readings NOTE The presence of dyshemoglobins such...

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Страница 16: ...g emergency air or land transport Portable and lightweight Weighs only 9 ounces 255 grams with out the batteries Ergonomically designed to fit comfortably in the palm of your hand Uses three standard alkaline batteries type LR 14 or three rechargeable type KR27 50 NiCad C cell batteries Battery life is approximately twenty four 24 hours in continuous mode or eighty 80 hours in spot check mode Brig...

Страница 17: ...mmunication cable is also connected here SpO2 DISPLAY The SpO2 value is shown here Dashes indicate the oximeter is unable to calculate the SpO2 value PULSE RATE DISPLAY The pulse rate value is shown in beats per minute BPM Dashes indicate the oximeter is unable to calculate the pulse rate value Flashing 255 indicates the pulse rate value is greater than 255 Figure 2 1 Oximeter Controls Patient Cab...

Страница 18: ...ck data and resets the patient number to P1 The oximeter turns off automatically two minutes after the sensor is removed from the patient or after the sensor is disconnected from the oximeter This feature extends the battery use time LOW BATTERY INDICATOR When about two hours of battery use time remains the left most bar graph segment lights The oximeter will continue to operate normally until the...

Страница 19: ...es and the absorption of the arterial and venous blood including the time varying effects of the pulse in the body tissues The oximeter processes these signals separating the time invariant parame ters tissue thickness skin color light intensity and venous blood from the time variant parameters arterial volume and SpO2 to identify the pulse rate and calculate oxygen saturation Oxygen saturation ca...

Страница 20: ...ell batteries type LR 14 You can use disposable alkaline batteries or rechargeable type KR27 50 batteries If you use disposable batteries be sure to dispose of them in compliance with your institution s guidelines and local ordinances If you use rechargeable batteries it s best to have two sets of batteries on hand That way you can use one set of batteries in the oximeter while the other set of ba...

Страница 21: ...ose of them in compli ance with your institution s guide lines and local ordinances If the old batteries are rechargeable be sure to charge them right away so they ll be ready to use again as soon as possible 4 Install three batteries in the oximeter battery compartment Make sure the batteries are installed in the proper direction 5 Slide the battery door closed push ing firmly until it snaps into...

Страница 22: ... when using the sensor 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 figure 3 4 Upon completion of patient monitoring detach the sensor and loosely coil finger sensor cable Do not wrap the finger sensor cable around the oxime ter 2 WARNING Misuse or improper handling of the sensor and cable could result ...

Страница 23: ...try Sensors Finger or Toe 3043 Sensor Universal Y 1300 Sensor Disposable Adult Finger Ear 3078 Sensor Ear Pediatric 15 45 Kg Finger 3044 Sensor Reusable Adult 3444 Sensor Reusable Comfort Clip 3178 Sensor Reusable Pediatric Finger or Toe 3043 Sensor Universal Y 1301 Sensor Disposable Pediatric Finger Ear 3078 Sensor Ear Infant 3 15 Kg Hand or Foot Toe Finger or Toe 3043 Sensor Universal Y 3025 Sen...

Страница 24: ...nts with long fingernails use the universal Y sensor 2 WARNING Prolonged use or the patient s condition may require changing the sensor site periodically Change sen sor site and check skin integrity circulatory status and correct alignment at least every 4 hours 2 WARNING When attaching sensors with Microfoam tape do not stretch the tape or attach the tape too tightly Tape applied too tightly may ...

Страница 25: ...SOR connector Measuring the Patient s SpO2 and Pulse Rate To begin measuring the patient s SpO2 and pulse rate press the R key When turned on the oximeter goes through this power up sequence The pulse strength bar graph segments light one at a time The oximeter s software revision is momentarily displayed The patient number for spot check printouts is momentarily dis played The format for the pati...

Страница 26: ...oxygen saturation calculated as a percentage The pulse rate display shows the patient s pulse rate in beats per minute BPM The pulse strength bar graph shows the patient s pulse strength the bar graph is scaled logarithmically to indicate a wide range of pulse strengths Figure 3 7 SpO2 Pulse Rate and Pulse Strength Bar Graph SpO2 Value Displayed Pulse Rate Value Displayed Pulse Strength Bar Graph ...

Страница 27: ...meter remembers all the spot check data and all the patient numbers for up to ninety nine 99 patients and sev enteen 17 hours of run time Manually Incrementing the Patient Number Press the R key while the oximeter is on to manually increment the patient number The new patient number is momentarily displayed and spot check data for the new patient is automatically saved Clearing All Spot Check Data...

Страница 28: ...ire user calibration To check the function of the device an optional Oximeter ECG Patient Simulator is available as an accessory BCI Cat 1606HH The simulator attaches to the oximeter in place of the sensor or patient cable It provides a known SpO2 and pulse rate signal to the oximeter allowing the oximeter s performance to be checked Follow the instructions included with the Oximeter ECG Patient S...

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Страница 30: ...ximeter 2 3350 Printer Cable 3 3339 PC Adapter Cable 4 Communication settings Interface Instructions 1 Disconnect the sensor from the oximeter 2 Connect the printer adapter cable part 3350 to the sensor connector on the unit 3 Connect 9 pin connector of PC adapter cable part 3350 to the printer adapter cable part 3339 Be sure to connect the 3339 to the end of the 3350 cable marked as printer Baud ...

Страница 31: ... be certified according to the respective IEC stan dards 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 sys tems requirements Anyone connecting additional equip ment to the signal input port or signal output port configures a medical system and therefore is responsible that the system complies...

Страница 32: ...number is displayed only and is not incremented The oximeter remembers all the spot check data and all the patient numbers for up to ninety nine 99 patients and sev enteen 17 hours of run time Manually Incrementing the Patient Number Press the R key while the oximeter is on to manually increment the patient number The new patient number is momentarily displayed and spot check data for the new pati...

Страница 33: ...t check data at all the message is printed 6 The oximeter does not automati cally turn itself off when print ing spot check data 7 If no valid data is collected for a patient number is printed 8 If valid data is collected for a patient number for less than one minute only the last measure ment is printed 9 If data is collected for a patient number for more than one minute the relative time since t...

Страница 34: ... open danger of corrosion do not recharge normal batteries Batteries and rechargeable batteries must be treated as special waste dispose of in accordance with local waste disposal regulations For information contact the local environmental protection offices or licensed waste disposal contractors Sensors Reusable Sensors Clean the reusable sensor s surfaces with a soft cloth moistened in a mild so...

Страница 35: ...faces with a soft cloth moistened in a mild soap solution If disinfection is required wipe the oximeter s surfaces with a soft cloth moistened in isopropyl alcohol Do not allow any liquid to enter any of the oximeter s openings Long Term Storage Remove the batteries from the oximeter before long term storage or if the oximeter won t be used for 6 months or more This protects the oximeter from dama...

Страница 36: ... patient cable and to the oximeter Reposition the sensor Reposition the sensor Try a new sensor or contact your authorized repair center for help Pulse rate is erratic intermittent or incorrect Sensor incorrectly positioned Patient motion Reposition the sensor SpO2 value is erratic intermittent or incorrect Poor patient perfu sion Patient motion Reposition the sensor Patient must remain still to o...

Страница 37: ...connected or printer power switch is Off Connect the printers power source and turn on the printer Printer interface assembly not securely connected Push on both ends of the printer interface assembly to ensure all the connections are tight Printer interface malfunction Contact your authorized repair center for help No trends in mem ory Collect trend data Sensor must be dis connected for spot chec...

Страница 38: ...ment in the vicinity off and on to isolate the offending equipment Reorient or relocate the other receiving device Increase the separation between the interfering equipment and this equipment If assistance is required contact Smiths Medical PM Inc Service Depart ment or you local representative 2 CAUTION This device has been tested and found to com ply with the limits for medical devices to the IE...

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Страница 40: ...R Manual Operation English and Spanish and Service English each 3025 Sensor Oximetry Wrap Infant 3 15 Kg each 3026 Sensor Oximetry Wrap Neonate 3 Kg each 3043 Sensor Oximetry Universal Y each 3044 Sensor Oximetry Finger each 3049 Strips Adhesive 40 pkg 3078 Sensor Oximetry Ear each 3134 Tape Attachment Neonatal 50 pkg 3135 Tape Attachment Infant 50 pkg 3136 Tape Attachment Neonatal 100 pkg 3137 Ta...

Страница 41: ... Manual Ordering Information For ordering information contact your local distributor or the Smiths Med ical PM Inc customer service department Smiths Medical PM Inc N7 W22025 Johnson Drive Waukesha WI 53186 USA Phone 262 542 3100 Fax 262 542 3325 Email Address info smiths bci com ...

Страница 42: ...play 0 46 inches 11 68 mm high Pulse Rate LED numeric display 0 38 inches 9 65 mm high Pulse Strength Logarithmically scaled 8 segment LED bar graph Keys R Q keys Range 0 99 Accuracy 2 at 70 99 Averaging 8 pulse beat average Display Response The display is to functional saturation The pulse strength bar graph is not proportional to pulse vol ume Display Update Rate 1 Hz SpO2 60 Hz pulse strength C...

Страница 43: ...ry Life Approximately 24 hours in continuous mode or 80 hours in spot check mode Dimensions Environmental Specifications Range 30 254 BPM Accuracy 2 at 30 254 BPM Averaging 8 second average Display Update Rate 1 Hz Width 3 25 inches 82 6 mm Height 6 3 inches 160 mm Depth 1 25 inches 31 75 mm Weight 9 ounces 255 grams without the batteries Operating Temp 0 55 C 32 131 F Storage Temp 34 70 C 29 158 ...

Страница 44: ...o 5VDC output voltage Negative voltage used by the analog section is generated as a by product of the main 5VDC supply Charge pump C55 D4 C69 is used to convert pulsatile voltage on the out put LX of U10 into negative voltage in the range of 4VDC to 6VDC The V RAM voltage used by the on off circuitry and RAM is generated either from the battery or from VCC when unit is on V RAM is taken straight f...

Страница 45: ...U18 voltage reference The output of the comparator signal BATT is used to detect battery voltage The following battery states are distinguished by this measurement system RS 232 communication interface is built around Q3 Q5 and Q6 It con verts CMOS voltage levels into RS 232 bipolar voltage levels Inverter U16C is used to disable communication interface circuitry when oximetry probe is plugged in ...

Страница 46: ...5 is used to generate voltage between 0 and 2 5VDC U5 is controlled serially by the processor Operational amplifier U2B together with transistor Q7 create a constant current sink The current is proportional to the voltage generated by variable potentiometer The H bridge Q8 Q9 is used to activate either LED red or infrared inside the oximeter probe The following table describes the states of the H ...

Страница 47: ... the ADC for measurement LED Controller LED controller is built around U22 and U23 buffers Data is latched into buffers by DSP LD signal Signal DSP EN is used to disable LED s at power up to limit initial surge current Signal Dictionary This section lists in alphabetical order the signal names used on the sche matics The signal s origin destination and purpose are described Signal Description ADCL...

Страница 48: ...meter chip U5 POT LD POT LD is used to select digital potentiometer chip U5 SDI Serial Data Input to digital potentiometer chip U5 PRB DET PRB DET is used to inform processor if probe is plugged in PRB FAULT Signal used to inform processor about probe cable problem QUIET Signal used to shut down power down supply during data acquisi tion RX External RS 232 receive CTS0 line RED DRV Used to control...

Страница 49: ...ifying glass Soldering iron and solder Solder wick or solder remover Connecting a DC Power Supply To verify some of the voltage measurements that follow you ll need to connect a variable output DC power supply in place of the three C cell batteries You must be careful to observe the polarity of J9 when doing this Follow these steps to connect a DC power supply in place of the C cell batteries TXA0...

Страница 50: ...arity may cause fuse F1 to blow Location Condition Nominal and Range T19 Oximeter on 5 VDC 0 1 VDC ANA 5 T18 Same as T19 Same as T19 FLTR 5 Same as TP14 Same as T19 ANA 5 Same as TP15 Same as TP15 FLTR 5 T16 Same as TP15 4 8 VDC to 6 2 VDC V REF T17 Oximeter on 2 5 VDC V RAM Oximeter on Oximeter off T19 minus 0 7 VDC V_BT minus 0 7 VDC U11 71 Oximeter on 3 072 MHz 50 duty cycle Low battery LED Whe...

Страница 51: ...nger from sensor Remove sensor from oximeter Turn on oximeter Oximeter should turn off 2 minutes 5 sec onds after finger is removed from sensor Oximeter should turn off in 2 minutes 5 seconds Current draw through J9 1 total battery cur rent Oximeter on sensor attached to oximeter no finger in the sensor with battery voltage at 3 5 VDC 0 2 VDC 110 mA 15 mA ...

Страница 52: ...er and data acquisition circuits Unless otherwise noted The waveforms are measured with respect to ground at J9 2 The oscilloscope is triggered on T2 falling edge The waveforms are measured with the finger sensor attached to the oximeter but no finger inserted in the sensor Connect CH1 probe to T10 T21 T22 T24 Verify the signal shown in the respective figures Measurement at T2 2V DIV 0 4mS Div 0V ...

Страница 53: ...Chapter 9 Service Maintenance and Repair 9 10 Oximeter Operation and Service Manual Measurement at T22 2V DIV 0 4mS Div 0V Measurement at T24 2V DIV 0 4mS Div 0V ...

Страница 54: ...sconnect the oximetry test fixture Turn oximeter board off and then on again Connect Finger probe to oximeter board and put your finger in the probe Verify SpO2 and Pulse Rate readings are displayed Verify that the pulse tone is heard when the pulse strength bar lights up Remove finger from finger probe Verify dashes Measurement at T24 2V DIV 0 4mS Div 0V 0V ...

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Страница 56: ...s Schematics Parts Lists Number Description Item Number of pages 71000A23 F ASM OXIMETER REDESIGN BOM A 1 1 71000A23 F ASM OXIMETER REDESIGN A 2 1 71264B1 PWB ASM MAIN BOARD REDESIGN A 3 1 71264B1 PWB ASM MAIN BOARD REDESIGN PARTS LIST A 4 3 71264S1 MAIN BOARD REDESIGN SCHEMATIC A 5 5 ...

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Страница 59: ...nc Patient Monitoring and Ventilation m Authorized Representative as defined by the Medical Device Directive Smiths Medical International Ltd Colonial Way Watford Herts UK WD24 4LG Phone 44 1923 246434 Fax 44 1923 240273 ...

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