Smiths Medical 1884SS Operation Manual Download Page 54

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Appendix C: Guidance and Manufacturer’s Declaration

C-2

Pulse Oximeter for Sleep Screening Operation Manual

IMMUNITY

ELECTROMAGNETIC ENVIRONMENT

GUIDANCE

Electrical fast transient/burst
IEC 61000-4-4

IEC 60601 TEST LEVEL A.C. Mains power voltage should be the typical

quality of a:

Commercial environment.

Hospital environment.

•

NA for power supply
lines.
±0.25 kV to ±1 kV
for input/output
lines.

•

COMPLIANCE LEVEL

NA for power supply
lines.
±0.25 kV to ±1 kV
for input/output
lines.

•

Surge
IEC 61000-4-5

IEC 60601 TEST LEVEL
NA
COMPLIANCE LEVEL
NA

Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11

IEC 60601 TEST LEVEL
NA
COMPLIANCE LEVEL

Note: U

is the A.C. mains voltage prior to application of the test level.

Summary of Contents for 1884SS

Page 2: ......

Page 3: ...2 1 Intended Use 2 1 Monitor Features 2 1 Theory of Operation 2 2 Chapter 3 Controls and Features 3 1 Monitor Front Panel 3 1 Monitor Operating Keys 3 2 Chapter 4 Operating Instructions 4 1 Unpacking the Monitor 4 1 Installing the Batteries 4 1 Attaching the Sensor to the Patient 4 2 Choosing the Sensor 4 2 Care and Handling of the Sensor 4 3 Checking the Sensor and Oximetry Cable 4 4 Cleaning or ...

Page 4: ...ption 8 1 How to Download Screenings from the Oximeter to the 1621 Software 8 1 Chapter 9 Maintenance 9 1 Schedule of Maintenance 9 1 Storage 9 1 Chapter 10 Troubleshooting 10 1 EMI Interference 10 2 Chapter 11 Optional Supplies Accessories 11 1 Ordering Information 11 1 Chapter 12 Specifications 12 1 Equipment Classification 12 1 Displays Indicators Keys 12 1 SpO2 12 1 Pulse Rate 12 2 Printer 12 ...

Page 5: ...agnetic Emissions Immunity C 1 Recommended Separation Distances C 4 Appendix D Revision History D 1 BCI Comfort Clip 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 All other names and marks mentioned are the trade names trademarks or service marks...

Page 6: ...Table of Contents iv Pulse Oximeter for Sleep Screening Operation Manual This page is intentionally left blank ...

Page 7: ...ED BY OPERATION OF LAW OR OTHERWISE INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE Seller disclaims responsibility for the suitability of the Product for any particular medical treatment or for any medical complications resulting from the use of the Product This disclaimer is dictated by the many elements which are beyond Seller s control...

Page 8: ...r To obtain warranty information outside the 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 material in good condition is not available it should be purchased from Smiths Medical PM Inc Damages o...

Page 9: ...ce personnel Serial Number Catalog Number F Printer On Off y Date of Manufacture x On Off 1 Non AP device 7 Do not reuse One use on one patient l Batch Code C Use By IPX1 Drip Proof Z Collect Separately 6 Caution Federal U S A law restricts this device to sale by or on the order of a physician keyword definition warning Tells you something that could hurt the patient or hurt the operator caution T...

Page 10: ...pe do not stretch the tape or attach the tape too tightly Any device tape VELCRO applied too tightly may cause inaccurate readings and blisters on the patient s skin lack of skin respiration not heat causes the blisters WARNING Incorrectly applied sensors may give inaccurate readings Refer to the sensor insert for proper application instructions WARNING Use only SpO2 sensors supplied with or speci...

Page 11: ... must be in compliance with IEC 601 1 1 systems requirements Anyone connecting additional equipment to the signal input port or the signal output port configures a medical system and therefore is responsible that the system complies with the requirements of the system standard IEC 601 1 1 WARNING IEC 950 approved equipment must be placed outside the patient environment The patient environment is d...

Page 12: ...ximeter on its side to prevent paper jams CAUTION Chemicals used in some cleaning agents may cause brittleness of plastic parts Follow cleaning instructions in this manual Notes NOTE Batteries are designed to be replaceable by individuals trained in this procedure Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components including batteries N...

Page 13: ...lts for sleep screening applications Ideally suited for use in overnight sleep screening applications allowing printing of summated data results Three modes of operation Verification Mode for spot checking Data Collection Mode for long term data collection in sleep screening environments and Trend Printing Mode for outputting summarized trend data to the built in printer or to a PC Device automati...

Page 14: ...ED light sources Detector Oximetry processes these signals separating the time invariant parameters tissue thickness skin color light intensity and venous blood from the time variant parameters arterial volume and SpO2 to identify the pulses and calculate functional oxygen saturation Oxygen saturation calculations can be performed because blood saturated with oxygen predictably absorbs less red li...

Page 15: ...in Data Collection Mode will be one flashing bar to conserve battery life Pulse Rate Numeric Display A number shows the patient s pulse rate value in beats per minute Dashes mean the monitor is not able to calculate the pulse rate value in Verification Mode In Data Collection Mode the Heart Rate display will be blank to conserve battery life Low Battery Indicator Low Battery is indicated by the to...

Page 16: ... mode momentarily pressing the F key will not activate the printer as the printer function is suppressed in this mode However in the Data Collection Mode pressing and holding this key will advance the paper in the printer Reloading the paper is allowed in this mode Trend Printing Mode Momentarily pressing the F key will activate a printout statistical sleep screening information Pressing the F key...

Page 17: ... standard AA alkaline cells IEC Type LR6 To install replace the batteries Depress the battery door tab and lift up Install the negative end of each battery first compressing the battery terminal spring until the positive terminal clears the positive tab Press the battery down into place Place battery door tabs into the slots of the monitor back panel depress the door tab and press the door into pl...

Page 18: ...type Disposable sensors are for single patient use and do not require cleaning or disinfecting Attach the sensor to the patient Choosing the Sensor Choose the appropriate sensor from the following chart patient site description Adult 45 kg Finger 3044 Sensor Oximetry Adult Finger reusable 3444 Sensor Oximetry Comfort Clip Finger reusable Finger or Toe 3043 Sensor Oximetry Universal Y reusable 1300...

Page 19: ...evice as shown in Figure 4 2 Figure 4 2 Disconnecting or connecting the sensor Do not use excessive force or unnecessary twisting when connecting disconnecting storing or 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 4 3 Figure 4 3 Positioning the cable of the finger sensor Upon c...

Page 20: ...cted to the monitor connect the oximetry cable to the monitor Carefully align and push the connector firmly into the monitor If not using the oximetry cable connect the sensor to the monitor Push the connector firmly into the monitor If the monitor is not already on press the x key to turn on the monitor warning If any of the integrity checks fail do not attempt to monitor the patient Use another ...

Page 21: ... the top LED segment of the pulse strength bargraph The Low Battery Indicator will flash rapidly when the batteries need to be replaced The Low Battery Indicator will flash rapidly if the monitor is trying to print and there is not enough battery life for printing warning When the LOW BATTERY INDICATOR flashes you must immediately replace the monitor s batteries Otherwise the monitor turns itself ...

Page 22: ...wn SpO2 and pulse rate signal to the oximeter This allows the oximeter s performance to be checked NOTE The 1606 Oximetry Patient Simulator does not calibrate the monitor the monitor does not require calibration The 1606 provides a known SpO2 and pulse rate to the monitor that allows you to check the monitor s performance NOTE The 1606 Oximetry Patient Simulator cannot be used to assess the accura...

Page 23: ...e powered up in this mode and the verification timer will be reset Once the verification timer reads 10 minutes the monitor exits theVerification Mode and enters the Data Collection Mode The user functions in Verification Mode are The display will show SpO2 and heart rate values if available otherwise dashes for invalid data are displayed The x key will turn the unit OFF without changing modes Pre...

Page 24: ...bar and heart rate display will be blank see Fig 4 5 Pressing and holding the x key for six 6 seconds will turn off the unit While pressing the x key the flashing bar will flash at a higher frequency indicating that the unit is about to be powered down NOTE If the x key is released before the six seconds elapses the bar will return to its normal flashing pattern After the power down the unit will ...

Page 25: ...unit will be powered up to the same Trend Printing mode Briefly pressing the F key will activate a printout statistical sleep screening information see Fig 7 1 Pressing the F key during the printout will terminate the printout Printing the printout can be repeated an unlimited number of times Pressing and holding the F key will advance the paper see pg 7 5 Reloading the paper is allowed in this mo...

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Page 27: ...he trend memory is cleared by pressing and holding the F key for 6 8 seconds at power up Replace batteries if unsure of life expectancy i e will they last long enough to complete the sleep screening See p 2 1 for battery life expectancy Following the Home User s Guide while teaching these tasks may help you and the home user Show the home user how to visually inspect the sensor and oximetry cable ...

Page 28: ...Chapter 5 Instructions for Training the Home User 5 2 Pulse Oximeter for Sleep Screening Operation Manual This page is intentionally left blank ...

Page 29: ...can be downloaded to a computer Trend data will be preserved for about one and a half minutes without battery power allowing battery replacement without losing trend data Clearing Trend Data Turn the monitor off Press and hold the F key then turn the monitor on Do not release the F key clr will flash in the monitors display while the F key is pressed When clr stops flashing the trend data is clear...

Page 30: ...Chapter 6 Trend Data 6 2 Pulse Oximeter for Sleep Screening Operation Manual This page is intentionally left blank ...

Page 31: ...to stop printing or unit will stop printing after the summary report has been printed The trend summary printout from the monitor s built in printer will contain the following sections see Figure 7 1 Sample Trend Printout Report Title The first section will contain a report title to indicate that a new printout has begun Patient Information The patient information section supplies a space for the ...

Page 32: ...be accounted for here Time per SpO2 range This section displays the total valid sample time that the readings were in a specified range Total duration below 90 SpO2 This section displays the total valid sample time that the SpO2 readings were below 90 Total duration 88 SpO2 below This section displays the total valid sample time that the SpO2 readings were 88 and below Longest single event with Sp...

Page 33: ...m Avg SpO2 83 SpO2 STD 12 Title Patient Information Study Duration Study Max Min STATISTICS Time per SpO2 range SpO2 95 99 90 94 85 89 80 84 70 79 0 69 Time 19 5 16 1 16 1 16 1 16 1 16 1 Time per SpO2 range SpO2 95 99 90 94 85 89 80 84 70 79 0 69 Duration 00 06 00 00 05 00 00 05 00 00 05 00 00 05 00 00 05 00 Total duration below 90 SpO2 00 20 00 Total duration 88 SpO2 below 00 20 00 Longest single...

Page 34: ...ing 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 Trends will be cleared by pressing and holding the F key for 6 to 8 seconds at power up A clr message will flash to indicate that trend clear is about to happen New data will not overwrit...

Page 35: ...per Advance CAUTION When printing or advancing the paper place the oximeter on it s side to prevent paper jams Also cutting the paper as shown below will facilitate feeding paper into the printer Fig 7 3 Paper Shape NOTE To tear paper off gently pull paper towards you tightly against the cutter to tear it off Use caution not to pull paper through the printer as this might damage the paper feed rol...

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Page 37: ...ll be needed 3389 Proprietary Serial Cable 1621 Oximetry Data Management Program CD ROM First the 1621 software must be installed on the PC Please see instructions on the CD ROM jacket for details Set up the 1621 Oximetry software to accept the following data format Data Format 19200 baud 1 start bit 8 data bits 1 stop bit no parity 19200 N81 After the software is installed and properly setup up c...

Page 38: ... will not function if the monitor and cable are not properly connected NOTE For more information on the downloading process please see the operation manual in the 1621 Oximetry Data Management Program Help menu NOTE See Appendix A for an alternative to the 1621 software Appendix A contains data format information and PC communications setup instructions SpO2 BPM x F PC 3389 Proprietary Serial Cabl...

Page 39: ...ipe the surfaces of the monitor with a soft clean cloth dampened in isopropyl alcohol Use only a cloth that is dampened not wet CAUTION Do not allow isopropyl alcohol or any liquid to enter any of the openings on the monitor Evidence that liquid has been allowed to enter the monitor voids the warranty 1 2 Storage Whenever possible the monitor should be stored at room temperature in a dry environme...

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Page 41: ... to obtain an accurate measurement The oximeter doesn t turn on Batteries weak Replace the batteries Batteries not installed or batteries incorrectly installed Ensure the batteries are installed correctly The oximeter displays only one flashing LED with no SpO2 or heart rate The oximeter has been on continuously and collecting data for 10 minutes and has gone into the Data Collection Mode If not c...

Page 42: ...his device The monitor is designed for use in environments in which the signal can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the monitor may not operate correctly The monitor generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with o...

Page 43: ...ape Attachment Neonatal 50 pkg 3135 Tape Attachment Infant 50 pkg 3136 Tape Attachment Neonatal 100 pkg 3137 Tape Attachment Infant 100 pkg 3138 Posey Wrap Attachment Universal Y 10 pkg 3178 Sensor Pediatric Finger 5 45 kg each 3311 Cable Patient Oximetry Extension 1 5m 5 feet each 3339 PC Adapter Cable Alternative Connection each 3350 Cable Printer Interface Alternative Connection each 3389 Propr...

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Page 45: ... Accuracy1 2 at 70 99 less than 70 is unspecified Alarms None Averaging 4 pulse beat average Display Response The display is to functional saturation Display Update Rate 1 Hz SpO2 60 Hz pulse strength Calibration Factory calibrated over the range of 70 to 100 SpO2 using human blood samples to functional saturation Test methods available upon request No in service calibration is required Sensor Red...

Page 46: ...tandard 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 printing or Intermittent monitoring 1 min on 2 min off 1 cycle 80 hours or 1600 cycles Dimensions Width 69 85mm 2 75 inches Height 167 64mm 6 6 inches Depth 36 322mm 1 43 inches Weight 369 grams 13 ounces with batteries Environmental Spec...

Page 47: ...Printer Adapter Cable Catalog No 3350 DB 9 Modem Cable Catalog No 3339 NOTE The DB9 PC Adapter Cable is an industry standard RS 232 null modem cable Power up the monitor Connect the printer communication cable labeled BCI to the monitor Connect the standard RS 232 null modem cable s DB 9 connector to the mating connector of the printer cable labeled Printer Connect the standard RS 232 null modem c...

Page 48: ...significant byte of the check sum As indicated in the table each pack includes length data block and check sum Data in the data block represents four second samples Data blocked is compressed The compression method is described below Each stored data byte is split into low and high nibbles except for the cases described later Each nibble can have a signed value in the range of 7 to 7 Bits 0 to 3 a...

Page 49: ...ect 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 95 High nibble is 2 Pulse Rate 82bpm 2 80 bpm 30 Low nibble is 0 SpO2 95 0 95 High nibble is 3 Pulse Rate 80bpm 3 83 bpm Note Your service repres...

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Page 51: ...to show the day setting Use the print key to set the desired day Press the power key again to show the month setting Use the print key to set the desired month Press the power key again to show the year setting Use the print key to set the desired year Press the power key again to exit the time setting menu After the power key is pressed a time stamp is printed and the monitor turns itself off Ver...

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Page 53: ...function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The 3403 pulse oximeter is suitable for use in all establishments including Domestic establishments Establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emis...

Page 54: ... of a Commercial environment Hospital environment NA for power supply lines 0 25 kV to 1 kV for input output lines COMPLIANCE LEVEL NA for power supply lines 0 25 kV to 1 kV for input output lines Surge IEC 61000 4 5 IEC 60601 TEST LEVEL NA COMPLIANCE LEVEL NA Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 IEC 60601 TEST LEVEL NA COMPLIANCE LEVEL...

Page 55: ...e level in each frequency range b CAUTION Interference may occur in the vicinity of equipment marked with the following symbol 4 Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed RF transmitters such a...

Page 56: ...the Frequency of RF Transmitter Meters 150 kHz to 80MHz d 1 2 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 01 0 12 0 035 0 07 0 1 0 38 0 11 0 22 1 1 2 0 35 0 7 10 3 8 1 1 2 2 100 12 3 5 7 0 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitt...

Page 57: ...ight up upon startup of the device Added warning about the oximeter displaying dashes or erroneous values under certain conditions Added caution about certain cleaning agents Added warning about incorrectly applied sensors Updated Theory of Operation Added note about the 1606 simulator not being used to access accuracy Added note about how to tear off paper from printer Added desat study info to S...

Page 58: ...Appendix D Revision History D 2 Pulse Oximeter for Sleep Screening Operation Manual This page is intentionally left blank ...

Page 59: ......

Page 60: ...ical Device Directive Smiths Medical International Ltd Colonial Way Watford Herts WD24 4LG UK Phone 44 1923 246434 Fax 44 1923 240273 H Manufactured By Smiths Medical PM Inc Patient Monitoring and Ventilation N7W22025 Johnson Drive Waukesha WI 53186 s ...

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