BCI 10 Operation Manual Download

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WW1020/WW1000

Operation Manual

English

Catalog Number WW1922en

Version 0, April 2009

Summary of Contents for 10

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Page 3: ...0 Oximeter 2 1 Intended Use for the WW1000 Oximeter 2 1 Monitor Features 2 1 Theory of Operation 2 2 Pulse Amplitude Index 2 3 Patented Technology WW1020 only 2 3 Chapter 3 Controls and Features 3 1 Front Display 3 1 Monitor Operating Key 3 2 Monitor Back and Bottom Panels 3 3 Chapter 4 Operating Instructions 4 1 Unpacking the Monitor 4 1 Powering the Oximeter 4 1 Installing the Batteries 4 3 Exte...

Page 4: ...1 Chapter 6 Optional Docking Station and Printer 6 1 Description 6 1 Docking Station 6 2 Powering the Docking Station 6 2 WW1090 Lithium Ion Li Rechargeable Battery Pack 6 3 Installing the Oximeter to the Dock 6 3 Downloading Data to PC 6 3 Printer 6 4 Attaching the Printer 6 5 Loading Paper 6 6 Choosing the Print Mode 6 7 Trend Data Condition Flags 6 8 Chapter 7 PC Communication Setup 7 1 Descrip...

Page 5: ... USB 11 7 Monitor Dimensions 11 7 Dock Dimensions 11 8 Auxiliary Inputs Outputs 11 8 Environmental 11 8 Equipment Classification 11 9 Design Standards 11 9 Appendix A Guidance and Manufacturer s Declaration A 1 Guidance and Manufacturer s Declaration A 1 Electromagnetic Emissions Emissions Test A 1 Electromagnetic Immunity Immunity Test A 2 Recommended Separation Distances A 4 The serial autocorre...

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Page 7: ...THER EXPRESS OR IMPLIED 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 of 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 bey...

Page 8: ...aterial including any 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 occurring in transit in other than original shipping containers are the responsibility of the shipper All cos...

Page 9: ...l definition 6 Caution Federal U S A law restricts this device to sale by or on the order of a physician R Type BF Equipment f Attention see instructions for use 7 Refer servicing to qualified service personnel This device has no alarms SpO2 Percent Oxygen Saturation p Pulse Rate beats per minute PI Pulse Amplitude Index Battery Charge Indicator External Power Indicator x On Off Key 1 Printer LED ...

Page 10: ...not be disposed of with general waste If purchased before that date they may also be sent for recycling if being 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 Y Disposal other countries When disposing of this device its batterie...

Page 11: ...NG Any monitor that has been dropped or damaged should be inspected by qualified service personnel prior to use to insure proper operation Warning If the accuracy of any measurement is in question verify the patient s vital signs by an alternative method and then check the monitor for proper functioning WARNING This device must be used in conjunction with clinical signs and symptoms This device is...

Page 12: ...ch site with an opaque material Warning Remove fingernail polish or false fingernails before applying SpO2 sensors Fingernail polish or false fingernails may cause inaccurate SpO2 readings Warning Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin with CO poisoning or methemoglobin with sulfonamide therapy will affect the accuracy of the SpO2 measurement WARNING Tissue damag...

Page 13: ... the patient to handle the device if the battery door has been removed except while installing new batteries WARNING Disconnect the external power supply from the monitor or Docking Station before disinfecting or cleaning the monitor WARNING Do not plug the monitor or Docking Station into an outlet controlled by a wall switch WARNING Disconnect the AC power supply from the outlet before disconnect...

Page 14: ...ARNING Use only the power supply included with your monitor or approved by Smiths Medical PM Inc Use of an inappropriate power supply may cause a patient shock hazard or cause the oximeter to stop monitoring See Chapter 10 Optional Supplies Accessories for additional specific information WARNING The Docking Station must have a Printer or Printer Port Cover installed Failure to do so may cause a ri...

Page 15: ...ity direction when replacing batteries CAUTION Do not allow water or any other liquid to spill onto the monitor or Docking Station Do not autoclave ethylene oxide sterilize or immerse the monitor or Docking Station in liquid Evidence that liquid has been allowed to enter the monitor or Docking Station voids the warranty CAUTION Where the equipment has accidentally gotten wet it should be wiped dry...

Page 16: ...ver which the SpO2 value is averaged pulse averaging means the number of seconds over which the pulse value is averaged NOTE Increasing or decreasing the averaging setting has no effect on the data update rate NOTE A Patient Simulator does not calibrate the monitor The monitor does not require calibration A Patient Simulator provides a known SpO2 and pulse rate to the monitor that allows the monit...

Page 17: ...ospital or clinical environment during emergency land transport and in the home WARNING The monitor was not designed or tested to be an apnea monitor Monitor Features Provides fast reliable SpO 2 pulse rate and pulse signal strength measurements on any patient from neonate to adult for the WW1020 or from small infant to adult for the WW1000 Maintains accurate readings during periods of patient mot...

Page 18: ...es Detector The oximeter 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 light than o...

Page 19: ...at varies from patient to patient Patented Technology WW1020 only This oximeter incorporates patented technology and noise reducing hardware to enhance the oximeter s ability to detect pulse amplitude in patients with poor peripheral perfusion Blood Pulse Detection Method Using Serial Autocorrelation SAC patent number 5 558 096 analyzes a digitized signal in real time and compares it with previous...

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Page 21: ...Pulse Signal Strength Bar Graph red The pulse strength bar graph sweeps with the patient s pulse beat The height of the bar graph is a logarithmic representation of the pulse signal strength Battery Charge Indicator green yellow if low The battery charge indicator shows the current state of charge of the installed battery LED segments will disappear as the battery becomes weaker When only one LED ...

Page 22: ...perating Key Figure 3 2 Monitor Operating Key x 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 1 1 ...

Page 23: ...ing an RS232 serial interface cable See Chapter 7 Connecting to a PC for details Sensor Storage Slot Reusable BCI sensors can be securely stored here when not in use by using a WW1080 Sensor Cradle Battery Compartment This compartment holds the disposable batteries or the rechargeable battery pack Data Input Output or Power Input Connector This connector can accept the AC power adapter or the USB ...

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Page 25: ...ter The AC power supply is required when utilizing the docking station to ensure the proper operation of the docking station with all accessories including auxiliary battery charger and optional printer WARNING The WW1020 WW1000 will not operate without batteries installed Properly charged batteries provide a reserve source of power in case of external power failure Never use an oximeter with disc...

Page 26: ...arges more green segments will light until all four are lit NOTE The AC Power supply does NOT charge AA LR6 alkaline batteries If no external power source is available the oximeter will draw battery power When the battery charge is low enough the Battery Indicator shows one yellow segment When the battery has less than approximately 10 minutes of charge left that segment will flash If no AC source...

Page 27: ...ept while installing new batteries To install replace the batteries Depress the battery door tab near the center of the oximeter and slide the cover off toward 1 the bottom of the monitor 2a If using AA LR6 alkaline batteries 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 N...

Page 28: ...afety hazard may result Ensure that hands are thoroughly dry before handling the AC power supply WARNING Do not place the monitor in the patient s bed or crib Do not place the monitor on the floor WARNING Failure to place the monitor away from the patient may allow the patient to turn off reset or damage the monitor possibly resulting in the patient not being monitored Make sure the patient cannot...

Page 29: ...tor CAT NUMBER OUTPUT POWER INPUT POWER WW1095 30 W AC power supply 100 240 VAC 50 60Hz WARNING Only use a power supply intended for use with this monitor Use of an inappropriate power supply may cause a patient shock hazard or cause the oximeter to stop monitoring CAUTION Use only the interconnect cables specifically intended for use with this device See Chapter 10 Optional Supplies Accessories f...

Page 30: ...attery Pack can be fast charged by installing it in the oximeter and supplying power using the AC Power Supply either directly or through the Docking Station The WW1090 Li Rechargeable Battery Pack can also be fast charged by installing it directly in the Docking Station and supplying power using the AC Power Supply NOTe To slow charge the WW1090 Lithium Ion Li Rechargeable Battery Pack install th...

Page 31: ...number is momentarily displayed After a few seconds the SpO2 value pulse rate pulse signal strength and PI bar graphs should be shown If not see Chapter 9 Troubleshooting for help WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device If the oximeter detects an error during power up ERR will display in the pulse rate section of the display A numeric e...

Page 32: ...ish Español es Italian Italiano it Continental Portuguese Português pt Brazilian Portuguese Português Brasil br Swedish Svenska sd Dutch Nederlands nl Stop pressing the key when the desired language is selected After five 5 seconds normal monitoring mode resumes Checking the Monitor s Performance Pulse oximeters do not require user calibration If checking the function of the device is desired an O...

Page 33: ...y be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary WARNING 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 WARNING Optical cross talk can occur when two or more sensors are placed in clo...

Page 34: ...7 WW3078 Sensor Reusable Ear Pediatric 15 45 kg Finger Finger or Toe Ear 3044 Sensor Reusable Adult 20 kg 3044S Spot Check Sensor Reusable Adult 3444 Sensor Reusable Comfort Clip 3178 Sensor Reusable Pediatric Finger 5 45 kg 3178S Spot Check Sensor Reusable Pediatric 3043 Sensor Reusable Universal Y 1301 Sensor Disposable Pediatric Finger 7 WW3078 Sensor Reusable Ear Infant 3 15 kg Hand or Foot To...

Page 35: ...ximetry cable are working properly WARNING Using a damaged oximetry sensor or cable may cause inaccurate readings Inspect each sensor and cable If a sensor or cable appears damaged do not use it Use another sensor or cable or contact your authorized service representative for help Warning Do not use more than one Oximetry Extension Cable The monitor may fail to operate properly if multiple Oximetr...

Page 36: ...n pulsatile component of the signal The PI value is represented as a 9 segment bar graph The more bars lit the higher the PI value and generally the better the sensor site If only the first one or two segments are lit the segment color changes to yellow indicating a technical alert condition This indicates that the oximeter is receiving a low signal quality from that sensor site and further degrad...

Page 37: ... 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 1 2 1 2 ...

Page 38: ...or Storage cradle or other safe place when not in use Use the proper cradle Three different sensor cradles are available for this oximeter Cradle Sensor Type 1 Should be used for BCI pediatric size finger sensors 2 Should be used for the 3444 Comfort Clip sensor 3 Should be used for the BCI adult size finger sensors Figure 4 9 Attaching the Sensor and Sensor Cradle to the Monitor Oximeter Sensor S...

Page 39: ...1 WW1090 Li Ion rechargeable battery pack optional 1 3311 Oximeter Cable 1 5 meters 5 feet Oximetry Sensor Oximetry Sensor Attachments 1 31169B88 WW1020 WW1000 Home Use Guide Note The doctor will prescribe the type and quantity of the sensors needed for home use Be sure that the proper type and quantity of sensor attachments are also prescribed The home use caregiver will also need these supplies ...

Page 40: ...ation or oximeter Make sure the monitor s POWER indicator is lit 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 Perform a pre use check Verify all display LEDs turn on at power up Route the cable safely from the patient to the monitor to prevent possible patient strangulation Attach the sensor s ...

Page 41: ...at at least one trend data point was saved for P10 Clearing the trend data resets the patient record number to P1 See Clearing Trend Data section in this chapter for information on clearing trends Memory Capacity The trend interval affects the maximum trend record length The trend interval is fixed at 4 seconds and the total record length is 6 days If the total trend record length is exceeded for ...

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Page 43: ...imeter and operate the printer while charging the internal and spare battery packs The Docking Station Provides a convenient and secure home base for the oximeter Recharges WW1090 Lithium Ion Li rechargeable battery pack installed in the oximeter Recharges an additional WW1090 Lithium Ion Li rechargeable battery pack stored in the Docking Station May be equipped with a WW1026 thermal printer Allow...

Page 44: ...Station away from the patient may allow the patient to turn off reset or damage the monitor possibly resulting in the patient not being monitored Make sure the patient cannot reach the monitor from their bed or crib The WW1095 AC Power Supply provides power to the Docking Station and connected accessories Connect the AC Power Supply to the dock using the data port or Power Input Connector The Dock...

Page 45: ...090 Lithium Ion Li rechargeable battery pack is placed in the dock as shown in figure 6 3 When the battery is charging the indicator flashes green After the battery is fully charged the indicator lights solid green Battery or charging errors are indicated by a yellow LED See Chapter 9 Troubleshooting for details Figure 6 3 Connecting the Rechargeable Battery Pack NOTE The battery in the Docking St...

Page 46: ...hat 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 Print Error Indicator This indicator will light if there is an error in printing Select Print Mode Key Press this key to change the print mode 1 2 3 1 2 3 4 4 ...

Page 47: ...meter and battery from the Docking Station prior to installing the printer will result in an error which may cause a faulty printout Remove the Docking Station printer port 2 cover Hook the tab on the top of the printer 3 to the groove at the top of the Docking Station Then swing the printer down to align and attach the printer to the dock s electrical connectors Install the screw as shown in figu...

Page 48: ...y 2 continuing to pull on clear door Remove existing spool if present 3 Place paper spool in holder so that 4 the paper exits over the top of the roll and drapes over the rubber roller as shown in figure 6 6C Figure 6 6A Release Printer Door Lift here Figure 6 6B Swing Open Paper Holder Figure 6 6C Place Paper Spool in Holder Close the paper holder door and the clear 5 cover Tear off any excess pa...

Page 49: ...en when printing is pending or in progress Note The oximeter must be installed in the Docking Station to print Note Thermal paper must be installed Mode 1 Real Time Mode prints data every 5 seconds See figure 6 7 Figure 6 7 Sample Real Time Data Log Mode 2 Numeric Trend Data prints in a tabular form See figure 6 8 Figure 6 8 Sample Numeric Trend Data 1 2 3 REALTIME DATA ID 001________________ hh m...

Page 50: ...e stored with the data These are indicated by symbols on the print out Condition Symbol Description Artifact WW1020 only Artifact indicator informs user of excess motion noise or other signal information that the algorithm interprets as potentially non physiological This flag is an indicator that pulse rate data has changed and now may be invalid Small Pulse WW1020 only Indicates the signal streng...

Page 51: ...eration 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 60950 for data processing equipment or IEC 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC 60601 1 1 systems requirements Anyone con...

Page 52: ...compatible with the specialized data format BCICP1030 by using the USB Interface Cable The following items will be needed Oximeter with or without the Docking Station User Compatible PC Application Software USB Interface Cable WW1089 AC Power Supply optional Figure 7 1A Bottom Panel of Oximeter Data Power Input Connector Figure 7 1B Bottom Panel of Docking Station ...

Page 53: ...n If using the WW1095 AC Power Supply connect it to the PC cable power input connector 2 Connect the interface cable to the PC s USB port 3 The oximeter is now ready to download data 4 The BCICP1030 data output format is available upon request Note 1Review the PC communication program s instructions to determine how to save the data to the PC Connect USB Cable to Monitor USB Interface Cable AC Pow...

Page 54: ...t no parity Select any available RS232 Com Port typically com1 or com2 Turn off the oximeter 2 Remove the oximetry sensor from the sensor connector 3 Connect the printer adaptor cable WW3350 to the sensor connector Make sure the BCI 4 end is connected to the oximeter Connect the PC adaptor cable s DB 9 connector to the mating connector of the printer cable 5 labeled Printer Connect the other end o...

Page 55: ...Dashes mean no measurements were available at that sample time Trended SpO2 pulse rate and PI values print every 4 seconds TREND DATA ID 009__________________ hh mm ss SpO2 Rate PI bpm 00 55 08 00 55 04 95 83 bpm 1 6 00 54 56 94 84 bpm 2 8 00 54 52 96 83 bpm 2 6 00 54 48 96 84 bpm 3 2 00 54 44 96 84 bpm 3 6 00 54 40 94 86 bpm 3 2 00 54 36 96 86 bpm 3 2 00 54 32 95 85 bpm 3 0 00 54 28 96 85 bpm 3 0...

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Page 57: ...is shipped with the monitor Routine Maintenance Maintenance Item Recommended Action Maintenance Interval WW1090 Li Ion rechargeable battery pack Charge the battery by connecting AC power to the monitor Replace the rechargeable battery pack When Low Battery Signal is observed After continuous use under battery power After approximately 300 charge cycles Monitor Surfaces and Docking Station Printer ...

Page 58: ... Before cleaning or disinfecting the printer unplug the AC adapter remove the batteries and remove the paper CAUTION Do not allow printer paper to become wet If the printer paper gets wet remove the paper immediately Do not use the printer until the paper is replaced CAUTION Disinfectant chemicals may affect the outer case over prolonged use however disinfection must be performed NOTE Use only a s...

Page 59: ...ccessory cable The accessory cable is not connected to the monitor The AC power cord is connected to a wall outlet that is controlled by a wall switch A non user serviceable fuse may have opened Check all power supplies and cables for proper connections Only connect the AC power cord to an outlet that is not controlled by a wall switch Contact your authorized service representative The External Po...

Page 60: ...the sensor Try a new sensor or contact your authorized service representative for help The pulse rate is erratic intermittent or incorrect The SpO2 sensor is improperly positioned on the patient The patient is experiencing poor perfusion The patient is moving too much There is too much ambient light around the SpO2 sensor Defective sensor or patient cable Reposition the sensor on the patient Confi...

Page 61: ...y seated in Docking Station The communications setup is not correct Contact your authorized service representative Remove the oximeter from the Docking Station and replace it assuring proper alignment Check the user connected auxiliary equipment and software Display shows RA ERR Remote alarm cable attached to the oximeter This is proper operation The WW1020 and WW1000 are not intended for use with...

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Page 63: ... Oximetry Disposable Neonate Small Infant 3 kg 10 box 1303 Sensor Oximetry Disposable Infant 3 15 kg 10 box 1606 Simulator Oximeter each WW1922 Manual Operation each WW1923 Manual Service each 3025 Sensor Oximetry Wrap Infant 3 15 kg each 3026 Sensor Oximetry Wrap Neonate Small Infant 3 kg each 3043 Sensor Oximetry Universal Y each 3044 Sensor Oximetry Finger each 3044S Spot Check Sensor Reusable ...

Page 64: ...dering 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 N7W22025 Johnson Drive Waukesha WI 53186 USA Phone 262 542 3100 Toll Free 800 558 2345 USA only Fax 262 542 0718 web site www smiths medical com E mail address info pm smiths...

Page 65: ...LED bar graph Pulse Signal Strength Logarithmically scaled 9 segment LED bar graph Display update rate SpO2 and Pulse rate 2Hz All other data 10Hz Display Refresh 50 Hz Indicators Visual External Power indicator green with power plug icon Battery charge indicator green yellow with 4 segment gauge green if 2 4 segments lit yellow if only one segment is lit Keys User Controls On Off Key x ...

Page 66: ...S unspecified Nellcorr DS100A 2 5 ARMS 2 5 ARMS unspecified 1 Because pulse oximeter measurements are statistically distributed only about two thirds of pulse oximeter equipment measurements can be expected to fall within the ARMS of the value measured by the CO oximeter 2 The WW1020 has been validated on 10 adult volunteers that did not have health problems and were non smokers The study was cond...

Page 67: ...S unspecified BCI 3043 2 ARMS 3 ARMS unspecified BCI 3044 2 ARMS 3 ARMS unspecified BCI 3044S 2 ARMS 3 5 ARMS unspecified BCI 3078 2 ARMS 3 6 ARMS unspecified BCI 3178 2 ARMS 3 ARMS unspecified BCI 3178S 2 ARMS 3 7 ARMS unspecified BCI 3444 2 ARMS 3 ARMS unspecified Nellcorr DS100A 2 ARMS 3 ARMS unspecified 1 Pulse Amplitude 6 Tested using industry standard simulator 2 Pulse Amplitude 1 to 0 1 Tes...

Page 68: ... 2 7 ARMS 2 12 ARMS 3444 2 ARMS 2 ARMS 1 Because pulse oximeter measurements are statistically distributed only about two thirds of pulse oximeter equipment measurements can be expected to fall within the ARMS of the value measured by the CO oximeter 2 The WW1000 has been validated on 10 adult volunteers that did not have health problems and were non smokers The study was conducted at oxygen conce...

Page 69: ... 3026 2 ARMS 3 ARMS 3043 2 ARMS 3 ARMS 3044 2 ARMS 3 ARMS 3044S 2 ARMS 3 5 ARMS 3078 2 ARMS 3 6 ARMS 3178 2 ARMS 3 ARMS 3178S 2 ARMS 3 7 ARMS 3444 2 ARMS 3 ARMS 1 Pulse Amplitude 6 Tested using industry standard simulator 2 Pulse Amplitude 1 to 0 1 Tested using industry standard simulator 3 Low Perfusion simulator accuracy specification based on BCI 1302 4 Low Perfusion simulator accuracy specific...

Page 70: ...I From Oximeter 0 00 0 07 0 08 0 15 0 16 0 31 0 32 0 63 0 64 1 27 1 28 2 55 2 56 5 11 5 12 10 23 10 24 20 47 Segments Lit 1Y 2Y 3G 4G 5G 6G 7G 8G 9G Pulse Amplitude Index for the WW1000 Oximeter Range 0 00 to 20 00 5 0 2 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 ...

Page 71: ...continuous use WW1000 Approximately 32 hours continuous use WW1020 Approximately 31 hours continuous use new WW1000 Approximately 54 hours continuous use new Charge Time AA LR6 disposable Custom rechargeable Not rechargeable Fast charges in approximately 3 hours Charge time affected by input power source and device loading See Chapter 4 Operating Instructions Charge Cycles Custom rechargeable 300 ...

Page 72: ... C 32 F to 104 F Li battery charging 5 C to 45 C 41 F to 113 F Operating Humidity Oximeter and accessories 15 to 95 non condensing Printer 20 to 85 non condensing Power Supply 5 to 95 non condensing Storage Temperature Oximeter and accessories 40 C to 75 C 40 F to 167 F WW1090 LI Ion rechargeable battery pack 20 C to 60 C 4 F to 140 F Printer 25 C to 70 C 13 F to 158 F Power Supply 10 C to 70 C 14...

Page 73: ...Degree of Protection Against ingress of Liquids IPX2 drip proof Degree of Mobility Portable Degree of Protection Against Electric Shock Type BF Electromagnetic classification CISPR 11 Group1 Class B see Appendix A Guidance and Manufacturer s Declaration Design Standards Safety EN60601 1 IEC 60601 1 EMC EN60601 1 2 IEC 60601 1 2 SpO2 ISO 9919 EN ISO 9919 FDA Draft Guidance for Pulse Oximeters July ...

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Page 75: ... electromagnetic environment specified below The customer or end user of the WW1020 WW1000 pulse oximeter should ensure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The WW1020 WW1000 pulse oximeter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause a...

Page 76: ...ommercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for...

Page 77: ...r and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 4 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may no...

Page 78: ...uipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz 800 MHz to 2 5 GHz 3 V m d 1 2 P 20 V m d 0 18 P 3 V m d 2 3 P 20 V m d 0 35 P 0 01 12 0 12 0 02 0 23 0 04 0 1 38 0 38 0 06 0 73 0 11 1 1 2 1 20 0 18 2 30 0 35 10 3 8 3 79 0 57 7 27 1 11 100 12 12 00 1 80 23 00 3 50 For transmitters rated at a ...

Page 79: ...g 1303 Sensor Oximetry Disposable Infant 3 15 kg 3025 Sensor Oximetry Wrap Infant 3 15 kg 3026 Sensor Oximetry Wrap Neonate Small Infant 3 kg 3043 Sensor Oximetry Universal Y 3044 Sensor Oximetry Finger 3044S Spot Check Sensor Reusable Adult WW3078 Sensor Oximetry Ear 3178 Sensor Pediatric Finger 5 45 kg 3178S Spot Check Sensor Reusable Pediatric 3311 Cable Oximetry 1 5 m 5 feet 3339 PC adapter ca...

Page 80: ...Appendix A Guidance and Manufacturer s Declaration A 6 Clinician s Operation Manual This page is intentionally left blank ...

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Page 82: ...3 240273 Australian Representative Smiths Medical Australasia Pty Ltd 61 Brandl Street Eight Mile Plains QLD 4113 Australia Tel 61 0 7 3340 1300 H Manufactured By Smiths Medical PM Inc N7W22025 Johnson Drive Waukesha WI 53186 1856 USA MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 IEC60601 1 CAN CSA C22 2 NO 601 1 21JU ...

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