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SPECTRO2 10 Pulse Oximeter Hand-Held Manual

1. indicate the monitor is not able to calculate the SpO value O Pulse Rate Numeric Display red A number shows the patient s pulse rate value in beats per minute Dashes indicate the monitor is not able to calculate the pulse rate value Clinician s Operation Manual 3 1 Chapter 3 Controls and Features Monitor Operating Key Figure 3 2 Monitor Operating Key ON OFF Key Momentarily press this key when the device is OFF to turn the monitor ON Press this key when the device is ON to turn the monitor OFF Press and hold this key when the device is OFF to clear the patient trend data 3 2 Clinician s Operation Manual Chapter 3 Controls and Features Monitor Back and Bottom Panels Figure 3 3 Monitor Back and Bottom Panels D Sensor RS232 Connector The sensor or an extension cable attaches here With the sensor removed trend data can be downloaded from this connector using an RS232 serial interface cable See Chapter 7 Connecting to a PC for details 2 Sensor Storage Slot Reusable BCI sensors can be securely stored here when not in use by using a WW1080 Sensor Cradle 3 Battery Compartment This compartment holds the disposable batteries or the rechargeable battery pack O Data Input Output or Power Input Connector This connector can accept the AC power adapter or the USB cable The docking station uses this connector for both power and data Clinician s Operation Manual 3 3 Chapter
2. Bar SPECTRO 20 SPECTRO 10 WW1020 WW1000 Operation Manual quuat UPN s s 0 m mom S Y E English Catalog Number WW1922en Version 0 April 2009 2009 Smiths Medical family of companies All rights reserved smiths medtcal Table of Contents Table of Contents Warranty and Service Information cccccccccsssssssssscccccsssssssssscccccsccscssssssssscoe V ce A AEPA e E EEEE E enter erent keer O nee ey aera ant A V WA a ueesetecs ve tae cece ceeee cer ec aceece coe ctens cet tence cacecace cca nas saceeeeeseneencver se V Limited Waray osesierenratreienann rreri aere eNEAN E S ENAA EAN AE ENAERE N E REE AAE ERTA ERARA V Disclaimer OF Warrantti Ssessnesonmino n AEA AEAN AERAR ANTERA V Conditions of Warranty sissano a e ASSE a vV Limitation of RemedieS ses ssssesssseesssessssessseessseessseesssesssseosseeosseeosseesssesssseosseeosserossersssessssrosserosseeosseesssessss ress vV Warranty PROC OCU G siansa narei AT EENE EEEE TEE EET vi CE NOUO coire aa ere SE ere eT eer rer rer ener eee re er ee vi Chapter 1 IntrodUcti Missccsssivscsscenssesccecvssceceviveccstsccssnataniecsevavasscosessansaecessssusse 11 About the Manual cet csccncs secvoan exeasccauttovescars capes ocossuvetaedcaaceevneintsseuseystanustnraccontacevesiotonsesveacsaresmaenturaeedenetesgesuentle 1 1 VS TIMTIOENOL Sy ITO OIS se szecsscayreycarsevenussepricoerteai cocanstnenstecancnsnasannen innate ea ratesnraiman aes 1
3. Display Update Rate 10 Hz gt As tested with Industry Standard Simulator The PI value maps to a 9 segment bar graph as shown below The two lowest bars 1 amp 2 are bi color Yellow amp Green and bars 3 through 9 are Green PI From 50 02 gt 0 2 gt 0 4 gt 0 6 gt 1 2 gt 2 6 gt 5 0 10 2 Oximeter 0 4 0 6 1 2 2 6 5 0 10 2 l x x se Segments Lit Printer Paper 58mm 2 28 inches Thermal Modes Real Time Tabular Trend Graphic Trend Paper Speed 12 5 mm sec Trend Graphs Headers print with graphs 11 6 Clinician s Operation Manual Chapter 11 Specifications Serial Data Output Power Input and Data Connector Data transferred through this connector is in a proprietary BCICP1030 format Format available upon request Sensor Connector Data Type ASCII comma delimited string output at 1 Hz Lines terminated with a Carriage return Serial Data Protocol RS232C 9600 baud 1 start bit 8 data bits 1 stop bit no parity Power Requirements Battery Type AA LR6 disposable 4 Alkaline Custom rechargeable Lithium lon L 7 4V replaceable rechargeable battery pack Use Time AA LR6 disposable WW1020 Approximately 26 hours continuous use WW 1000 Approximately 32 hours continuous use Custom rechargeable WW1020 Approximately 31 hours continuous use new WW 1000 Approximately 54 hours continuous use new Charge Time AA LR6 disposable Not rechargeable Custom rechargea
4. Incorrectly applied sensors may give inaccurate readings Refer to the sensor insert for proper application instructions Choose the appropriate sensor from the following chart Select the sensor based on the patient s size available application site attachment method and other pertinent clinical information A N See the sensor s instruction insert for detailed attachment methods and other important information BCI Sensors PATIENT DESCRIPTION Adult 3044 Sensor Reusable Adult over 45 kg 3044S Spot Check Sensor Reusable Adult 3444 Sensor Reusable Comfort Clip Finger or Toe 3043 Sensor Reusable Universal Y 1300 Sensor Disposable Adult Finger Q Ear WW3078 Sensor Reusable Ear Pediatric 3044 Sensor Reusable Adult gt 20 kg 15 45 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 Finger or Toe 3043 Sensor Reusable Universal Y 1301 Sensor Disposable Pediatric Finger QD Ear WW3078 Sensor Reusable Ear Infant Hand or Foot 3043 Sensor Reusable Universal Y 3 15 kg Toe 3025 Sensor Reusable Wrap Infant Finger or Toe 1303 Sensor Disposable Infant ee All Extension Cable 3311 Cable Oximetry 1 5 meters 5 feet NEONATE SENSORS FOR THE WW1020 ONLY Neonate Hand or Foot 1302 Sensor Disposable Neonate Small Infant Q under 3 kg Foot 30
5. LED Brightness fh default 8 of 10 Trend Interval SE default 4 seconds Oximeter High Sensitivity H5 WW1020 only default off Oximeter Averaging Atty WW1020 only default 8 seconds pulse rate 8 beat SpO Language Flr User selectable While the language setting is displayed successive key presses will cycle through the language selections English m default e French Fran ais Fr German Deutsch d Spanish Espa ol E 5 Italian Italiano f Continental Portuguese Portugu s PE Brazilian Portuguese Portugu s Brasil far e Swedish Svenska Seq Dutch Nederlands mi 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 Oximetry Patient Simulator Smiths Medical PM Inc catalog number 1606 is available as an accessory The simulator attaches to the oximeter in place of the sensor It provides a known SpO gt and pulse rate signal to the oximeter NOTE A Patient Simulator does not calibrate the monitor The monitor does not require calibration A Patient Simulator provides a known SpO value and pulse rate to the monitor that allows the monitor s performance to be checked NOTE A Patient Simulator cannot be used
6. 1 NOW AEM SS TEES AOE OE N A OO E N O A 1 3 Gre Un gk EEAO A A ee T AAAA OA AOA AAAA A A ee ee eee 1 7 PIG TOC acct rca eet E E E E E E E E E 1 8 Chapter 2 Intended Use and Monitor Features eesscccssccccsccccscccsscecsscecsseee 2 1 Intended Use for the WW1020 OXiIMete f ses sssesssseessseesssesssseesseeesseeesseessseessseeoseeosserosseesssessssrosserosseeosseessss 2 1 Intended Use for the WW1000 OXiMete f sss ssssessssessssesssesssseesseessseeesseessseessseosserosseeosseesssessssrosserosserosseessss 2 1 MONITO FESTON E r i E a E deuc stan es sesh et eee eee cn unedize testes 2 1 Theon or operatio D oana NE E ENE 2 2 PINS Fin ICES MOCK osiin E E E E N 2 3 Patented Technology WW1020 only s esssesssesssesssesssesssesssesssessseesseesseessseosseosseossrosseosseosseosseosseosseosseesseesseees 2 3 Chapter 3 Controls and FeatureS sssecssccccsccecscceccccccsccccsceccsccccseecsscecsseeesseee 3 1 PORED D I ar a A EE AENA AE E E E A 3 1 Monitor Operating Key aches deco acct iain iE EEEE EAA AA A Ei EER 3 2 Monitor Back and Bottom Panels s seessesseessesssessesssesseesscsseessesseesseosesssesseesseeseesscoseesseossessesseesseeseesseeseesseossesss 3 3 Chapter 4 Operating Instructions sesssscecsssccccssceocssecososecosssecesssseeossseeesssse 4 1 Unpacking the MONTO cascsose sassasceaasesnssutacactaratsnsssrasasonsossgs cate nyaassagavetvasaats cevetsshvsauassoetssatgonsssbensmeseaaustoniecoctann
7. 16 pin docking connector for power and data 0 C to 55 C 32 F to 131 F 0 C to 50 C 32 F to 122 F 0 C to 40 C 32 F to 104 F 5 C to 45 C 41 F to 113 F 15 to 95 non condensing 20 to 85 non condensing 5 to 95 non condensing 40 C to 75 C 40 F to 167 F 20 C to 60 C 4 F to 140 F 25 C to 70 C 13 F to 158 F 10 C to 70 C 14 F to 158 F 10 to 95 non condensing 10 to 90 non condensing 5 to 95 non condensing 3050 m 10 000 ft max ISO 9919 transport rated NOTE The monitor may not meet performance specifications when stored or used outside the temperature and humidity ranges listed above Clinician s Operation Manual Chapter 11 Specifications Equipment Classification Type of Protection Against Electric shock Class Il or Internally Powered Mode of operation Spot Check non continuous Degree of Protection Against ingress of Liquids IPX2 drip proof Degree of Mobility Portable Degree of Protection Against Electric Shock Type BF Electromagnetic classification 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 SpO gt ISO 9919 EN ISO 9919 FDA Draft Guidance for Pulse Oximeters July 2007 Clinician s Operation Manual 11 9 Chapter 11 Specifications This page is intentionally left blank 11 10 Clinician s Op
8. 27 05 95 75 bpm DNANDHAND HD HHO HL AP AP AW AP oP oP OP Figure 6 7 Sample Real Time Data Log Mode 2 Numeric Trend Data prints in a tabular form See figure 6 8 Title Se02 Rate P o Patient Record Number 3 bpm 6 93 Dpr 96 94 bpm 96 90 bpm 96 89 bpm Trended SpO pulse rate and PI values printed every 4 seconds Figure 6 8 Sample Numeric Trend Data Clinician s Operation Manual 6 7 Chapter 6 Optional Docking Station and Printer Mode 3 Graphic Trend Mode prints in a chart format See figure 6 9 NO NO O1 O gt gt gt gt Pulse Rate bpm gt Pp pp Figure 6 9 Sample Graphic Trend NOTE While printing trends the printer will pause for approximately 20 seconds after 10 seconds of printing This allows the thermal print head to cool A small gap may appear on each printout when printing resumes NOTE Invalid SpO data and SpO values between 0 and 50 will be printed as 50 Trend Data Condition Flags Each time a trend interval occurs and data is stored certain conditions active at that time are stored with the data These are indicated by symbols on the print out CONDITION SYMBOL DESCRIPTION Artifact indicator informs user of excess motion noise or other signal information that the algorithm Artifact interprets as potentially non physiological WW1020 only This flag is an indicator that pulse rate data has changed an
9. 3 Controls and Features This page is intentionally left blank 3 4 Clinician s Operation Manual Chapter 4 Operating Instructions Chapter 4 Operating Instructions Unpacking the Monitor The following items are shipped with the oximeter e Monitor e Three 3 sensor cradles WW1080 e Spot check sensor 3044S Four 4 AA LR6 alkaline batteries e Operation manual e Service manual CD Carefully remove the monitor and its accessories from the shipping carton Save the packing materials in case the monitor must be shipped or stored Compare the packing list with the supplies and equipment received Powering the Oximeter The oximeter will operate from battery power or from external power with battery back up The optional WW1095 30 Watt AC power supply may be used to provide power to the oximeter 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 discharged batteries to monitor a patient as the monitor may not operate properly in the case of external power failure The oximeter can obtain external power in the following ways e The oximeter can be placed in its d
10. BCI 1300 Clinical accuracy based on BCI 1302 6 Clinical accuracy based on BCI 3026 Clinical accuracy based on BCI 3044 8 Clinical accuracy based on BCI 3178 Clinical accuracy based on BCI 1302 10 Clinical accuracy based on BCI 3026 Clinical accuracy based on BCI 3044 12 Clinical accuracy based on BCI 3178 Clinical accuracy based on BCI 1300 14 For neonatal patients 1 SpO was added to account for theoretical differences in pulse oximetry function between adult and neonatal hemoglobin This investigation was performed on adults only S Motion patterns used consisted of tapping and rubbing Subjects varied the motion frequencies to a maximum of 300 cycles per minute A maximum amplitude of approximately 2 5 cm was used in this study 11 2 Clinician s Operation Manual Chapter 11 Specifications Pulse Rate for the WW1020 Oximeter Pulse Rate Range 20 300 bpm Pulse Rate Resolution 1BPM Pulse Rate Averaging 8 seconds Pulse Rate Accuracy Pulse Rate Accuracy Pulse Rate Accuracy in Pulse Rate Accuracy in Normal Conditions Low Perfusion Conditions in Motion Conditions Sensor 20 300bpm 25 250bpm 20 300bpm 3 Nellcorr 2 Arms 3 Arms unspecified DS100A 1 Pulse Amplitude 6 Tested using industry standard simulator Pulse Amplitude 1 to 0 1 Tested using industry standard simulator 3 Low Perfusion simulator accuracy specification based on BCI 1302 4 Low Perfusio
11. WW1098 WW1101 1300 1301 1302 DESCRIPTION QTY Pulse Oximeter each Protective glove red each Protective glove yellow each Protective glove green each Protective glove blue each each Thermal Printer Paper Replacement Sensor Cradles 3 Rubber Feet for Mounting Bracket Replacement pair USB interface cable each Rechargeable battery pack LI lon each Universal AC mains adapter 30W each Universal Mounting Bracket each each 10 box 10 box 10 box 1303 10 box 1606 Simulator Oximeter each Sensor Oximetry Wrap Infant 3 15 kg Sensor Oximetry Wrap Neonate Small Infant lt 3 kg Sensor Oximetry Universal Y 3135 Tape Attachment Infant 50 pkg 3136 100 pkg 3137 100 pkg 3138 10 pkg 3178 each 3178S each 3311 Cable Oximetry 1 5 m 5 feet each The BCI 1302 and 3026 oximetry sensors should not be used on neonatal patients with the WW1000 Mounting Bracket Strap Replacement Sensor Oximetry Disposable Adult Finger Sensor Oximetry Disposable Pediatric Finger 15 45 kg Sensor Oximetry Disposable Neonate Small Infant lt 3 kg Sensor Oximetry Disposable Infant 3 15 kg Tape Attachment Neonatal Small Infant Tape Attachment Infant Posey Wrap Attachment Universal Y for use with 3025 3026 and 3043 Sensor Pediatric Finger 5 45 kg Spot Check Sensor Reusable Pediatric monitor Testing has not been conducted for the WW1000 for patients less than 30 days ol
12. and order spare parts for the device supplied All information contained in this document is believed to be current and accurate as of the date of publication or revision but does not constitute a warranty Warranty Limited Warranty Smiths Medical PM Inc Seller warrants to the original purchaser that the Product not including accessories shall be free from defects in material and workmanship under normal use if used in accordance with its labeling for three years from the date of shipment to the original purchaser Seller warrants to the original purchaser that the reusable oximeter sensors supplied as accessories shall be free from defects in materials and workmanship under normal use if used in accordance with its labeling for one year from the date of shipment to the original purchaser USA only Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY AS CONDITIONED AND LIMITED IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES WHETHER 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 beyond Seller s control such as diagnosis of patient conditions under which the Product may
13. ethylene oxide sterilize or immerse the monitor in liquid Clean the surfaces of the monitor with a soft cloth moistened in water or a mild soap solution If disinfecting is necessary wipe the surfaces of the monitor with a 70 isopropyl alcohol solution If there is contamination with blood borne pathogens or other potentially infectious materials then the use of an approved disinfectant of appropriate spectrum for the suspected organisms is appropriate Then wipe the surfaces with a soft water moistened cloth WARNING Do not allow water isopropyl alcohol or any other liquid to enter any of the openings on the monitor Unplug the AC power cord from the monitor before cleaning or disinfecting CAUTION Where the equipment has accidentally gotten wet it should be wiped dry externally and allowed to dry thoroughly before use CAUTION 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 soft cotton cloth to clean the monitor s screen Do not clean the screen with tissues paper towels or any other paper based wipe Paper based wipes can scratch the screen Storage Whenever possib
14. format e Data Type ASCII e Data Format 9600 baud 1 start bit 8 data bits 1 stop bit no parity e Select any available RS232 Com Port typically com1 or com2 2 Turn off the oximeter 3 Remove the oximetry sensor from the sensor connector 4 Connect the printer adaptor cable WW3350 to the sensor connector Make sure the BCI end is connected to the oximeter 5 Connect the PC adaptor cable s DB 9 connector to the mating connector of the printer cable labeled Printer 6 Connect the other end of the PC adaptor cable to the PC s RS232 Com Port selected in step 1 7 Turn on the oximeter to start sending all of the stored trend data to the PC NOTE BH Review the PC communication program s instructions to determine how to save the data to the PC 7 4 Clinician s Operation Manual Chapter 7 PC Communication Setup Output Format Trend data is transmitted in the format shown in Figure 7 4 TREND DATA __ _ 1p 009 hh mm ss SpO2 Rate PI 3 bpm 3 JOS S525 00255204 956 B3 Bpm 1 6 00 54 56 94 84 bpm 2 8 00254257 966 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 S86 bpm 3 26 00 54 32 95 oo Dom 3 0 Q 00 54 28 966 85 ppm 3 06 5 4 00 54 24 95 81 bpm 00254200 ae Figure 7 4 Typical ASCII Trend Data Output Title Patient Record Number E Newest data sample is printed first Dashes mean no measurements we
15. lit Downloading Data to PC Data may be sent to a computer through the Docking Station using the WW1089 USB Interface Cable See Chapter 7 Connecting to a PC for details Clinician s Operation Manual 6 3 Chapter 6 Optional Docking Station and Printer Printer Figure 6 4 Printer Keys and Indicators D Print Mode Indicators These indicators light according to what print mode is selected See Choosing the Print Mode section later in this Chapter The Print Mode Indicator will blink green when printing is pending or in progress amp gt Start Stop Print Key Press this key to start or stop printing amp Print Error Indicator This indicator will light if there is an error in printing CD Select Print Mode Key Press this key to change the print mode 6 4 Clinician s Operation Manual Chapter 6 Optional Docking Station and Printer Attaching the Printer The optional WW1026 thermal printer attaches to the Docking Station with a single screw as shown in Figure 6 5C Follow the steps below WARNING The Docking Station must have a Printer or Printer Port Cover installed Failure to do so may cause a risk of electrical shock to the patient or operator or risk damage to the equipment To attach the printer to the Docking Station 1 Remove the oximeter and battery and disconnect any cable from the Docking Station NOTE Failure to remove the oximeter and battery from the Docking Station prior to installing
16. rate and PI reading along with any applicable condition flags and a time stamp every four 4 seconds The stored readings are called trend data The monitor can store at least 144 hours of trend data for a combination of all 99 available patient record numbers Incrementing the Patient Record Number Each time the monitor is turned on the patient record number is displayed during the power up sequence If valid trend data was collected from the previous patient the patient record number is incremented at power up If no valid trend data was collected from the previous patient the patient record number is not incremented For example if the last time the oximeter was on it displayed patient 10 P tf the next time it will be P provided that at least one trend data point was saved for FP fi Clearing the trend data resets the patient record number to FP f 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 all patients combined each new trend entry will replace the oldest overall trend entry Clearing Trend Data To clear all of the trend memory and reset the patient record number to Pf turn the monitor off Then push and hold the on off key until _ r stops flashing in the Pulse Rate dis
17. service representative for help if necessary NOTE Obstructions or dirt on the sensor s red light or detector may cause checks to fail Make sure there are no obstructions and the sensor is clean Clinician s Operation Manual 4 1 Chapter 4 Operating Instructions Hold the connector rather than the cable when connecting or disconnecting the finger sensor to the device Figure 4 7 Disconnecting or Connecting the Finger Sensor to the Device Do not use excessive force or unnecessary twisting when connecting disconnecting storing or when using the sensor Pulse Amplitude Index The Pulse Amplitude Index PI bar graph can be useful in assessing the relative quality of the chosen sensor site The PI value is a relative measure of pulse signal strength over time at a pulse oximeter monitoring site and is non pulsatile in nature Pulse Amplitude Index is defined as PI 100 AC DC where AC is the alternating current pulsatile component of the signal and DC is direct current non pulsatile component of the signal 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 degradation of the signal quality could cause the o
18. the printer will result in an error which may cause a faulty printout Remove port cover using a screwdriver 2 Remove the Docking Station printer port Figure 6 5A Remove the Docking Station Printer Port Cover cover Hook the tab on the top of the printer to the Docking Station here 3 Hook the tab on the top of the printer 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 4 Install the screw as shown in figure 6 5C 5 Reconnect any cables and replace the oximeter and battery 6 The printer is now ready to load paper Install screw here Figure 6 5C Mate and Align the Dock and Printer Clinician s Operation Manual 6 5 Chapter 6 Optional Docking Station and Printer Loading Paper The printer uses 58mm wide thermal paper See Chapter 10 Optional Supplies amp Accessories for part number and ordering information To load the paper follow the steps illustrated below 1 Release printer door by lifting clear cover Figure 6 6A Release Printer Door 2 Swing open paper holder by continuing to pull on clear door 3 Remove existing spool if present 4 Place paper spool in holder so that the paper exits over the top of the roll and drapes over the rubber roller as shown in figure 6 6C Figure 6 6C Place Paper Spool in Holder 5 Close the paper holder door and the clear cover 6 Tear off a
19. to assess the accuracy of a pulse oximeter and or sensor NOTE Follow the instructions included with the Patient Simulator 48 00 Clinician s Operation Manual Chapter 4 Operating Instructions Attaching the Sensor to the Patient To attach the sensor to the patient 1 Choose the appropriate sensor See sensor table for additional information 2 If using a reusable sensor clean or disinfect the sensor per Cleaning or Disinfecting the Sensors section in this chapter Q Disposable sensors are for single patient use and do not require cleaning or disinfecting 3 Check the sensor and oximetry cable for damage and integrity See Checking the Sensor and Oximetry Cable section for additional information 4 Attach sensor to the patient WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours When attaching sensors with Microfoam tape do not stretch the tape or attach the tape too tightly Tape applied too tightly may cause inaccurate readings and blisters on the patient s skin lack of skin respiration not heat causes the blisters SpO measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if
20. 020 WW1000 gt 60 dip in Uy gt 60 dip in U7 pulse oximeter requires IEC 61000 4 11 for 5 cycles for 5 cycles continued operation during power mains interruptions lt 70 Uy lt 70 Uz it is recommended that the gt 30 dip in Uy gt 30 dip in U WW1020 WW1000 pulse for 25 cycles for 25 cycles oximeter be powered from an uninterruptible power lt 5 Uz lt 5 Uy supply or a battery gt 95 dip in Uy gt 95 dip in Uy for 5 sec for 5 sec Power frequency Power frequency magnetic 50 60 Hz fields should be at levels magnetic field characteristic of a typical commercial or hospital IEC 61000 4 8 environment Note Uy is the a c mains voltage prior to application of the test level A 2 Clinician s Operation Manual Appendix A Guidance and Manufacturer s Declaration GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The WW1020 WW1000 pulse oximeter is intended for use in the 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 IEC 60601 TEST IMMUNITY TEST LEVEL Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 2 Hz Modulation 20 V m 80 MHz to 2 5 GHz 1kHz Modulation COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communication equipment should be used no closer to any part of t
21. 1 5 Pulse Amplitude Index for the WW1020 Oximeter e sssesssesssesssesssesssesssessseesseessesoseeoseroserosseosseosseosseossee 11 6 Pulse Amplitude Index for the WW1000 Oximeter sssesssesssesssesssesssesssesssessseeoseesseeoseeosseosseosseosseosseossee 11 6 A L E E EEE E E P EA E I OI IEE EN E ANA E OIA A E A ee 11 6 aD OUT OU eea TEE TANE E E 11 7 Power Input and Data Connector es seesssesssesseeseesseeseesscesseosesssesseesscoseesseosersseoseessesseessceseesseoneesseoserssess 11 7 ISON CONS ON aoran puerai er AE ESNEA RA vo E NAAA E ES E A 11 7 POWEOF Reguireme tS sinsin ea AANE EEA AR EDAEN NEAT 11 7 BaO aeei EA EEE N AEE E E AENA ee eee ae 11 7 PS CU E A E A AA A AEE EA E A N A E O 11 7 UD AEEA E Re TSer tint riC earn tia hase pester rte Tener 11 7 Monitor DIMENSION c penne eee ett meer ter nent nnn eT rang nen rn nr er ve ere ree ee meee er ener 11 7 Dock DIMENSION asenon EEEE TETEE ERARE a EE R AEA RRO 11 8 Auxillary NPU OUTPUTS sscsceinaraseneeensersacortassastacenseateanegisonsoreg AN NAON AEREE NTER EEES E EEA ETNEK AREE ETET 11 8 EVV UO URN VC AL ee E EE E E A AEE 11 8 Equipment Classification sssisssisisiserinsorsissnaanstsuonansvinosawicnnsrainiennraninanananida raen ena ibikan enamik i einan datki ko iiaiai 11 9 BISE SSI LA E LEE o E E E N A 11 9 Appendix A Guidance and Manufacturer s Declaration csscccssssssosoesA 1 Guidance and Manufacturer s Declaration sssssssesssseessseesssesssseoss
22. 26 Sensor Reusable Wrap Neonate Small Infant SMALL INFANT SENSORS FOR THE WW1000 ONLY Small Infant Hand or Foot 1302 Sensor Neonate Small Infant disposable Q under 3 kg Foot 3026 Sensor Wrap Neonate Small Infant reusable The BCI 1302 and 3026 oximetry sensors should not be used on neonatal patients with the WW1000 monitor Testing has not been conducted for the WW1000 for patients less than 30 days old These sensors may however be used on older patients 4100 Clinicians Operation Manual Chapter 4 Operating Instructions Nellcor Sensor WW1020 Only PATIENT SITE DESCRIPTION Adult Finger DS100A finger sensor reusable over 45 kg Cleaning or Disinfecting the Sensors Clean or disinfect reusable sensors before attaching to a new patient WARNING Unplug the sensor from the monitor before cleaning or disinfecting WARNING Do not autoclave ethylene oxide sterilize or immerse the sensors in liquid Clean the sensor with a soft cloth moistened in water or a mild soap solution To disinfect the sensor wipe the sensor with a 70 isopropyl alcohol solution If there is contamination with blood borne pathogens BBPs or other potentially infectious materials OPIMs then the use of a facility approved disinfectant of appropriate spectrum for the suspected organisms is appropriate CAUTION Do not immerse the sensor in any liquid CAUTION Cleaning with disinfectants including alcohol may shorten the life of
23. Appendix A Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity Test GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The WW1020 WW1000 pulse oximeter is intended for use in the 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 ELECTROMAGNETIC COMPLIANCE ENVIRONMENT IMMUNITY TEST IEC 60601 TEST LEVEL LEVEL GUIDANCE Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD concrete or ceramic tile 8 kV air 8 kV air If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power supply 2 kV for power Mains power quality should transient burst lines supply lines be that of typical commercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input lines output lines Surge 1 kV differential mode 1 kV differential Mains power quality should mode be that of typical commercial IEC 61000 4 5 or hospital environment 2 kV common mode 2 kV common mode Voltage dips short lt 5 U lt 5 U7 Mains power quality interruptions and gt 95 dip in U7 gt 95 dip in U should be that of typical voltage variations for 0 5 cycle for 0 5 cycle commercial or hospital on power supply environment If the user input lines lt 40 U7 lt 40 Uz of the WW1
24. Clinical accuracy based on BCI 1300 gt Clinical accuracy based on BCI 3026 6 Clinical accuracy based on BCI 3044 Clinical accuracy based on BCI 3178 8 Low Perfusion simulator accuracy and specification based on BCI 1302 Low Perfusion simulator accuracy and specification based on BCI 3026 10 Low Perfusion simulator accuracy and specification based on BCI 3044 11 Pulse Amplitude 1 to 0 3 Tested using industry standard simulator 12 Low Perfusion simulator accuracy and specification based on BCI 3178 11 4 Clinician s Operation Manual Chapter 11 Specifications Pulse Rate for the WW1000 Oximeter Pulse Rate Range 30 254 bpm Pulse Rate Resolution 1 bpm Pulse Rate Averaging 8 seconds Pulse Rate Accuracy Pulse Rate Accuracy Pulse Rate Accuracy BCI Sensor in Normal Conditions in Low Perfusion Conditions 30 254bpm 30 250bpm Pulse Amplitude 6 Tested using industry standard simulator Pulse Amplitude 1 to 0 1 Tested using industry standard simulator 3 Low Perfusion simulator accuracy specification based on BCI 1302 Low Perfusion simulator accuracy specification based on BCI 3026 gt Low Perfusion simulator accuracy specification based on BCI 3044 6 Pulse Amplitude 1 to 0 3 Tested using industry standard simulator Low Perfusion simulator accuracy and specification based on BCI 3178 Clinician s Operation Manual 11 5 Chapter 11 Specifications Pulse Amplitu
25. Medical PM Inc Use only the power supply included with your monitor or one approved by Smiths Medical PM Inc WARNING Ensure the device s AC rating is correct for the AC voltage at your installation site before using this monitor The monitor s AC rating is shown on the external power supply If the rating is not correct do not use the monitor Contact the Smiths Medical PM Inc service department or your authorized service representative for help AA Clinician s Operation Manual Chapter 4 Operating Instructions AC Power The AC power supply can plug into the oximeter Figure 4 3 or into the WW1089 USB interface cable Figure 4 4 Power Input Connector AC Power Supply Figure 4 3 AC Power Supply AC Power Supply Optional A f Connect AC Power Power Input Here Optional Connector USB Interface Cable to PC USB Interface 5 Connect USB Cable nil Ez TY Cable to Monitor Figure 4 4 Interconnect Cable AN Refer to Chapter 10 Optional Supplies amp Accessories to verify the proper AC power supply for your application The following power supplies are suitable for use with this monitor CAT NUMBER OUTPUT POWER INPUT POWER WW1095 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
26. The Clinician s Operation Manual provides installation operation and maintenance instructions for the health care professional trained in monitoring respiratory and cardiovascular activity These instructions contain important information for safe use of the product Read the entire contents of these Instructions For Use including Warnings and Cautions before using the monitor Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient Definition of Symbols SYMBOL DEFINITION Caution Federal U S A law restricts this device to sale by or on the order of a ohysician Type BF Equipment Attention see instructions for use Refer servicing to qualified service personnel Clinician s Operation Manual 1 1 Chapter 1 Introduction SYMBOL DEFINITION ouova connector S reave Comer OOO forane SCS e fowom OOOO Disposal EU Countries Under the Waste Electrical and Electronic Equipment WEEE Directive 2006 96 EC and implementing regulations all devices and service items within the scope of the Directive purchased new after August 13 2005 must ae be sent for recycling when ultimately becoming waste Devices and items must not be disposed of with general waste a Collect If purchased before that date they may also be sent for recycling if being Separately replaced on a one for one like for like basis this varies depending on the country Recy
27. Trend Checksum Error Chapter 9 Troubleshooting CORRECTIVE ACTION Connect AC Power to the Docking Station Take trend data See Chapter 6 Optional Docking Station and Printer for details of loading paper Contact your authorized service representative for help Close the printer door Install a roll of printer paper 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 This is proper operation The WW1020 and WW1000 are not intended for use with the remote alarm cable Attach a sensor to the oximeter Try anew sensor If the problem persists contact your authorized service representative Contact your authorized service representative Contact your authorized service representative Display shows Err Internal oximetry failure Contact your authorized service representative Clinician s Operation Manual Chapter 9 Troubleshooting This page is intentionally left blank 9 4 Clinician s Operation Manual Chapter 10 Optional Supplies and Accessories Chapter 10 Optional Supplies and Accessories CAT NO WW1000 WW1018R WW1018Y WW1018G WW1018B WW1020 Pulse Oximeter with Serial Autocorrelation each WW1025 Docking Station WW1026 Printer Must be used with Docking Station WW1025 each WW1027 5 pk WW 1080 se WW1081 WW1089 WW1090 WW1095
28. a 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 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 60601 1 1 Clinician s Operation Manual WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Clinician s Operation Manual Chapter 1 Introduction IEC 60950 approved equipment must be placed outside the patient environment The patient environment is defined as an area 1 5 m 4 92 feet from the patient Figure 1 1 Patient Environment X A The oximeter 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 discharged batteries to monitor a patient Inspect battery terminals for corrosion or contamination The monitor may not operate properly if battery terminals are corroded or contaminated Do not use until battery terminals have been properly cleaned and repaired Check expiration date of batteries The monitor may not operate properly if expired batteries are used Do not use until proper batteries can be obtained Remove device batt
29. a way that will prevent the patient from becoming entangled in the cable If necessary use tape to secure the cable If there is a risk of the AC power supply becoming disconnected from the monitor during use secure the cord to the monitor several inches from the connection Ensure the device s AC rating is correct for the AC voltage at your installation site before using this monitor The monitor s AC rating is shown on the external power supply If the rating is not correct do not use the monitor Contact the Smiths Medical PM Inc service department or your authorized service representative for help 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 amp Accessories for additional specific information The Docking Station must have a Printer or Printer Port Cover installed Failure to do so may cause a risk of electrical shock to the patient or operator or risk damage to the equipment Under certain clinical conditions pulse oximeters may display dashes if unable to display SpO and or pulse rate values Under these conditions pulse oximeters may also display erroneous values These conditions include but are not limited to patient motion low perfusion cardiac arrhythmias high or low pulse rates or a combination of the above conditions F
30. 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 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 60601 1 1 IEC 60950 approved equipment must be placed outside the patient environment The patient environment is defined as an area 1 5 m 4 92 feet from the patient PATIENT ENVIRONMENT Clinician s Operation Manual 7 1 Chapter 7 PC Communication Setup Power Input and Data Connector Port Data can be transferred to a computer running software that is compatible with the specialized data format BCICP1030 by using the USB Interface Cable The following items will be needed e Oximeter with or without the Docking Station e User Compatible PC Application Software USB Interface Cable ReF WW1089 e AC Power Supply optional Data Power Input Connector Figure 7 1A Bottom Panel of Oximeter Figure 7 1B Bottom Panel of Docking Station 7 2 Clinician s Operation Manual Chapter 7 PC Communication Setup How to Set Up Equipment Refer to Figure 7 2 for the cable co
31. ailure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury Verify that all LEDs light emitting diodes on the display light up upon startup of the device Clinician s Operation Manual Chapter 1 Introduction Cautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Federal U S A law restricts this device to sale by or on the order of a physician N Do not disassemble unit not user serviceable Refer to qualified service personnel Failure to charge the monitor while the monitor is in long term storage may shorten the battery life Charge the monitor while it is in storage to ensure the longest battery life Due to limitations of the Li lon chemistry the rechargeable battery pack should not be charged at ambient temperatures above 45 C 113 F or below 5 C 41 F The WW1090 rechargeable battery pack is shipped with only 30 of full charge The battery pack must be charged completely before use The WW1090 rechargeable battery pack utilizes Li lon secondary cells Dispose of spent batteries in compliance with your institution s guidelines and local ordinances Observe proper battery polarity direction when replacing batteries Do not allow water or any other liquid to spill onto the monitor or Docking Station Do not autoclave
32. ange 0 100 Functional Saturation Display Maximum 99 SpO Resolution 1 count SpO SpO Averaging 8 beats Calibration Factory calibrated over range 70 to 100 SpO using human blood y g PY2 g samples to functional saturation Test methods are available upon request No in service calibration is required Sensors Red 660 nm 2 mW typical Infrared 905 nm 2 2 4 mW typical SpO Accuracy 70 to 100 SpO less than 70 SpO is undefined SpO Accuracy in SpO Accuracy in SpO Accuracy in Sensor Normal Conditions Low Perfusion Conditions Motion Conditions BCI 1300 3 Anus BCI 130 3 V Ams BCI 1302 unspecified BCI 1303 unspecified BCI 3025 unspecified BCI 3026 unspecified BCI 3043 unspecified BCI 3044 unspecified BCI 30445 unspecified BCI 3078 unspecified BCI 3178 unspecified BCI 31785 unspecified BCI 3444 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 Agms of the value measured by the CO oximeter The WW1020 has been validated on 10 adult volunteers that did not have health problems and were non smokers The study was conducted at oxygen concentrations evenly distributed over an SpO gt range of 70 100 3 Pulse Amplitude 1 to 0 1 Tested using industry standard simulator Clinical accuracy based on
33. assscssnssansonaensiasleioeaseieatansassassebesiorasinavinsies 4 11 Checking the Sensor and Oximetry Cable sssesssesssessseesseesseesseesseesseeoseeoseeoecosseoseeesseesseesseesseesseessersseesss 4 11 P lse Amplitude Mde a ciciesssacivssesnescscusascvosvusictss uaa ssunseoaelieitesantveustensacarisescaesteataseesneninacatsauscranensteodaaeutel 4 12 Storing the SENSO seose e Aana E RaRo aa aS eaS Eanan 4 14 AONE USO e a E E I E T EEA A A EE 4 15 Equipment and Supplies Checklist for Home US ss sssesssessseessessseesseesseesseesseeoneconecesecesecesscesseesseesss 4 15 Training the Home Use CareGiver sssssscscsssssssssscscscssssssessscsssescsessssesesesssssesesescsesssesseseseaeacssseeeeseaes 4 16 Chapter 5 Patient Record Number and Trend Dataa cscccssssccsssssccsseses D 1 Deser O opea R R eteiccenseisaw annie 5 1 Incrementing the Patient Record Number cseesesssscsssssesssscsssssssesssssscsescsssessssesesesesessssesesesescseeseseseseaees 5 1 Ee AEE E EPEA ESANI EAA A A I ANN T 5 1 Clearing Trend TD AU as sc cot osacessnsat case tacopincictsoeaed a E Aoa aSa REO 5 1 irenda Data G0 ble Ul aeenenen antemene rrr emcee rt etre NT Tn Ste tenn anti en nnn ane Mente moter ry tra imnnn Ts rs C err eer 5 1 Chapter 6 Optional Docking Station and Printer c ccsccsccccsssssccesssssees 6 1 FS MV asec cnet cece A E E ci ana Ge A A E N A E A E A E I E AT 6 1 DORMO O rE E 6 2 Powering the Docking StatiON sissu
34. at least every 4 hours When attaching sensors with Microfoam tape do not stretch the tape or attach the tape too tightly Tape applied too tightly may cause inaccurate readings and blisters on the patient s skin lack of skin respiration not heat causes the blisters Use only SpO sensors supplied with or specifically intended for use with this device 1 3 Chapter 1 Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING 1 4 Incorrectly applied sensors may give inaccurate readings Refer to the sensor insert for proper application instructions Do not autoclave ethylene oxide sterilize or immerse the sensors in liquid This may cause damage to the sensor which may cause inaccurate readings Unplug the sensor from the oximeter before cleaning or disinfecting to prevent damaging the sensor or monitor and to prevent user safety hazards Measurements made at sites with low perfusion are potentially inaccurate Always use measurements in conjunction with other clinical signs and symptoms SpO measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine fluorescein and patent blue V PBV may adversely affect the accuracy of the SpO
35. be used handling of the Product after it leaves Seller s possession execution of recommended 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 manufactured by Seller This warranty does not cover normal wear and tear and maintenance items Limitation of Remedies The original purchaser s exclusive remedy shall be at Seller s sole option the repair or replacement of the Product THIS IS THE EXCLUSIVE REMEDY In no event will Seller s liability arising out of any cause whatsoever whether such cause is based on contract negligence strict liability tort or otherwise exceed the price of the Product and in no event shall Seller be responsible for consequential incidental or special damages of any kind or nature whatsoever including but not limited to lost business revenues and profits Clinician s Operation Manual V Warranty and Service Information Warranty Procedure To obtain warranty service in the USA you must request a Return Authorization RA number from Technical Service Reference the RA number when returning your Product freight and insurance prepaid to Smiths Medical PM Inc Phone 262 542 3100 N7W22025 Johnson D
36. ble Fast charges in approximately 3 hours Charge time affected by input power source and device loading See Chapter 4 Operating Instructions Charge Cycles 300 to 80 capacity Custom rechargeable AC Charger WW1095 30 Watt AC Power Supply 9V 3A output Input of 100 240 VAC 50Hz 60Hz USB WW1089 USB Interface Cable Input 5V 500mA max USB powered source Output 9V 230mA max to oximeter Length Maximum 5 meters 16 4 feet Monitor Dimensions Width 85 mm 3 3 inches Height 154 mm 6 1 inches Depth 45 mm 1 7 inches Weight 340 grams 12 ounces with four 4 AA batteries 369 grams 13 ounces with rechargeable battery pack Clinician s Operation Manual 11 7 Chapter 11 Specifications Dock Dimensions DIMENSION WITHOUT PRINTER WITH PRINTER 107 mm 4 2 inches 160 mm 6 3 inches 84 mm 3 3 inches 84 mm 3 3 inches 109 mm 4 3 inches 109 mm 4 3 inches 570 grams 20 ounces 850 grams 30 ounces Auxiliary Inputs Outputs Sensor DB9 Data or Power Input Connector Environmental Operating Temperature Oximeter and accessories Printer Power Supply Li battery charging Operating Humidity Oximeter and accessories Printer Power Supply Storage Temperature Oximeter and accessories WW1090 LI lon rechargeable battery pack Printer Power Supply Storage Humidity Oximeter and accessories Printer Power Supply Altitude Shock and vibration Non standard
37. cling instructions to customers using Smiths Medical products are published on the internet at http www smiths medical com recycle Disposal other countries When disposing of this device its batteries or any of its accessories ensure that any negative impact on the environment is minimized Contact your local waste disposal service and use local recycling or disposal schemes Separate any other parts of the equipment where arrangements can be made for their recovery either by recycling or energy recovery The main batteries are potentially harmful and will require separate disposal according to manufacturer s instructions or local regulations Note If applicable EU national or local regulations concerning waste disposal must take precedence over the above advice 1 2 Clinician s Operation Manual KEYWORD Chapter 1 Introduction DEFINITION WARNING Something that could hurt the patient or hurt the operator CAUTION Something that could damage the monitor NOTE Other important information Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Clinician s Operation Manual This device is not intended for continuous patient monitoring This device is intended to measure the patient s SpO and pulse rate values There are no audible or visible alarms The monitor was not designed or tested to be an ap
38. ct your authorized service representative for help Reposition the sensor on the patient Confirm signal level with PI and signal bar graphs Reposition the sensor on the patient Make sure that the patient remains still Place the extremity on a pillow that acts as a buffer to motion Shield the SpO gt sensor with a towel Try a new sensor or contact your authorized service representative for help Confirm signal level with PI and signal bar graphs Reposition the sensor on the patient Patient must remain still to obtain an accurate measurement Try a new sensor or contact your authorized service representative for help Clinician s Operation Manual Other PROBLEM No printout on optional printer 2 malfunction indicator on the printer is lit Real time or trend data is not transmitted Display shows rA Ces LI Display shows or Cas Display shows Ls l i Eri Display shows JC Lu POSSIBLE CAUSE AC power is not connected to the Docking Station No trends in memory No paper or paper incorrectly loaded Printer interface malfunction Printer door open Printer out of paper An accessory cable is defective Oximeter is not properly seated in Docking Station The communications setup is not correct Remote alarm cable attached to the oximeter No sensor attached to the oximeter Defective sensor or patient cable EEPROM checksum Error
39. d These sensors may however be used on older patients Clinician s Operation Manual 10 1 Chapter 10 Optional Supplies and Accessories CAT NO DESCRIPTION 3339 PC adapter cable WW3350 Printer adapter cable 3444 Sensor Oximetry Finger Comfort Clip Ordering Information Outside the USA for ordering information contact your local distributor In the USA for ordering information contact the customer service department at the address or phone number below Smiths Medical PM Inc Phone 262 542 3100 N7W22025 Johnson Drive Toll Free 800 558 2345 USA only Waukesha WI 53186 USA Fax 262 542 0718 web site www smiths medical com E mail address info om smiths medical com 10 2 Clinician s Operation Manual Chapter 11 Specifications Chapter 11 Specifications Displays SpO 2 digit LED display 19 mm high Pulse Rate 3 digit LED display 12 7 mm high PI 9 segment LED bar graph Pulse Signal Strength Logarithmically scaled 9 segment LED bar graph Display update rate SpO and Pulse rate 2Hz All other data 10Hz Display Refresh 50 Hz Indicators Visual External Power indicator JD green with power plug icon Battery charge indicator fimm 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 Clinician s Operation Manual 11 1 Chapter 11 Specifications SpO for the WW1020 Oximeter SpO R
40. d now may be invalid Small Pulse f WW1020 only kh Indicates the signal strength is lt 3 Indicates a problem with sensor placement or that no Check Sensor sensor is plugged into the sensor connector No valid parameter data is available Only displayed if the oximeter has not detected a valid pulse at any time after power up Indicates that Searching too Lon j J J p the oximeter has searched for more than 20 seconds but no pulse was detected Indicates the oximeter has searched for more than Lost Pulse 20 seconds a finger is detected in the sensor but a previously detected pulse is no longer present 6 8 Clinician s Operation Manual Chapter 7 PC Communication Setup Chapter 7 PC Communication Setup Description Real Time and Trend Data may be sent to a PC from the oximeter in the following ways e The Data Power Connector of the oximeter or of the Docking Station may be connected to a PC using the USB Interface Cable reF WW1089 Trend data or Real Time patient data will be downloaded using a proprietary data protocol e The oximeter sensor can be replaced with the WW3350 or 3339 cable to transfer comma separated value CSV ASCII Trend Data via RS232 WARNING When connecting this monitor to any instrument verify proper operation WARNING 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
41. de Index for the WW1020 Oximeter Range 0 03 to 20 00 0 01 increments Pulse Amplitude Index is defined as PI 100 AC DC where AC is the alternating current pulsatile component of the signal and DC is direct current non pulsatile component of the signal It is a relative measure of pulse signal strength over time at a pulse oximeter monitoring site and is non pulsatile in nature Display 9 segment green yellow LED bargraph logarithmic scale Display Update Rate 10 Hz The oximeter will display dashes Invalid data for SpO and PR when the PI value is below 0 03 Low perfusion performance is verified by simulator testing 6 As tested with Industry Standard Simulator The PI value maps to a 9 segment bar graph as shown below The two lowest bars 1 amp 2 are bi color Yellow amp Green and bars 3 through 9 are Green PI From 0 00 0 08 0 16 0 32 0 64 1 28 2 56 5 12 10 24 Oximeter 0 07 0 15 0 31 0 63 1 27 2 55 5 11 10 23 20 47 o Pulse Amplitude Index for the WW1000 Oximeter Range 0 00 to 20 00 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 of the signal It is a relative measure of pulse signal strength over time at a pulse oximeter monitoring site and is non pulsatile in nature Display 9 segment green yellow LED bargraph logarithmic scale
42. e WW1025 Docking Station The WW1095 AC power supply is required for charging and can be used with both the oximeter and the Docking Station External Power WARNING Disconnect the external power supply from the monitor before disinfecting or cleaning the monitor WARNING Do not plug the monitor into an outlet controlled by a wall switch WARNING Do not allow any moisture to contact the AC power supply connectors ora safety 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 reach the monitor from their bed or crib WARNING Failure to carefully route the cable from the sensor to the monitor may allow the patient to become entangled in the cable possibly resulting in patient strangulation Route the cable in a way that will prevent the patient from becoming entangled in the cable If necessary use tape to secure the cable WARNING If there is a risk of the AC power supply becoming disconnected from the monitor during use secure the cord to the monitor several inches from the connection WARNING Patient safety can be compromised by the use of a power supply not supplied by Smiths
43. e Amplitude Index The PI value is a relative measure of pulse signal strength over time at a pulse oximeter monitoring site and is non pulsatile in nature Pulse Amplitude Index is defined as PI 100 AC DC where AC is the alternating current pulsatile component of the signal and DC is direct current non pulsatile component of the signal For more information see Pulse Amplitude Index in Chapter 4 Operating Instructions NOTE The PI value is a relative value that 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 pulse data If similar characteristics to previous data are recognized the device confirms a valid pulse In essence an individual s pulse data is retained and used as a template to accept or reject future pulse signals Patented technology digital signal processing and a greatly improved signal to noise ratio provide for improved performance Clinician s Operation Manual 2 3 Chapter 2 Intended Use and Monitor Features This page is intentionally left blank 2 4 Clinician s Operation Manual Chapter 3 Controls and Features Chapter 3 Controls and Fea
44. ected An External AC Power Supply cord is not connected to the monitor or accessory 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 The USB cable is not connected to a source of power or the USB power source is not operating AC Power is connected The USB cable is not connected to a source of power or the USB power source is not operating The battery is missing The battery is drained The battery is defective Clinician s Operation Manual CORRECTIVE ACTION Replace or recharge the batteries Connect to source of AC power Ensure the batteries are installed correctly Connect to source of AC power This is proper operation Replace or recharge the batteries Replace or recharge the batteries Connect to source of AC power 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 Check all cable connections and confirm PC USB hub or other source of USB power is working correctly This is proper operation Check all cable connections and confirm PC USB hub or other source of USB power is working correctly Replace the battery Charge or replace the battery Replace the battery Contact your auth
45. eds the applicable RF transmitter compliance level above the WW1020 WW1000 pulse oximeter should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the WW1020 WW1000 pulse oximeter P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Clinician s Operation Manual A 3 Appendix A Guidance and Manufacturer s Declaration Recommended Separation Distances RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE WW1020 WW1000 PULSE OXIMETER The WW1020 WW1000 pulse oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the WW1020 WW1000 pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the WW1020 WW1000 pulse oximeter as recommended below according to the maximum output power of the communication equipment SEPARATION DISTANCE ACCORDING TO RATED MAXIMUM FREQUENCY OF TRANSMITTER OUTPUT POWER OF TRANSMITTER 80 MHz to 800 MHz 800 MHz to 2 5 GHz 20V m 20V m d 0 18V P 2 d 0 35 P 12 00 23 00 For transmitters rated at a maximum output power not listed Shove the recommended separation distance d in meters m can be estimated using the equation applicable
46. eeosseeosseesssesssseosseeosseeosseessseossseosseeossees A 1 Electromagnetic Emissions Emissions TeSt se sssessesssesseesscsseesscoseesseoseossesseesseeseesecoseesseoseossesseessee A 1 Electromagnetic Immunity Immunity TeSt ss sesesssesssesssesssesssessseesseesssessseosseosseosseosseosseosseosseosseosseesseesseess A 2 Recommended Separation DiStanCeS ssesssesssessesseesseeseesseeseesseessessesssesseeseeosceseesseossessesseesseeseesscosersseossesss A 4 The serial autocorrelation technology SAC in the WW1020 oximeter is covered by U S Patent No 5 558 096 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 of their respective owners Clinician s Operation Manual iji Table of Contents This page is intentionally left blank Clinician s Operation Manual Warranty and Service Information Warranty and Service Information Proprietary Notice Information contained in this document is copyrighted by Smiths Medical PM Inc and may not be duplicated in full or part by any person without prior written approval of Smiths Medical PM Inc Its purpose is to provide the user with adequately detailed documentation to efficiently install operate maintain
47. eration Manual Appendix A Guidance and Manufacturer s Declaration Appendix A Guidance and Manufacturer s Declaration Guidance and Manufacturer s Declaration The WW1020 WW1000 pulse oximeter is intended for use in the electromagnetic environment specified in the tables within this appendix NOTE The WW1020 WW1000 pulse oximeter system must be put into service according to the provided EMC information to ensure proper operation Electromagnetic Emissions Emissions Test GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The WW1020 WW1000 pulse oximeter is intended for use in the 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 ELECTROMAGNETIC ENVIRONMENT EMISSIONS TEST COMPLIANCE GUIDANCE RF emissions Group 1 The WW1020 WW1000 pulse oximeter uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The WW1020 WW1000 pulse oximeter CISPR 11 is suitable for use in all establishments Harmonic emissions IEC Class A including domestic establishments and those 61000 3 2 directly connected to the public low voltage power supply network that supplies buildings n es Compiles used for domestic purposes IEC 61000 3 3 Clinician s Operation Manual A 1
48. eries prior to long term storage Do not allow the patient to handle the device if the battery door has been removed except while installing new batteries Disconnect the external power supply from the monitor or Docking Station before disinfecting or cleaning the monitor Do not plug the monitor or Docking Station into an outlet controlled by a wall switch Disconnect the AC power supply from the outlet before disconnecting it from the monitor Leaving the AC power supply connected to an AC power outlet without being connected to the monitor may result in a safety hazard Do not allow any moisture to contact the AC power supply connectors or a safety hazard may result Ensure that hands are thoroughly dry before handling the AC power supply Do not place the monitor or Docking Station in the patient s bed or crib Do not place the monitor or Docking Station on the floor Failure to place the monitor or Docking 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 1 5 Chapter 1 Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING 1 6 Failure to carefully route the cable from the sensor to the monitor may allow the patient to become entangled in the cable possibly resulting in patient strangulation Route the cable in
49. es 4 1 Powering the OX INC CEP scssesrengserscoccspesesensacteascio suspends cassie cestbrutaptortedenuioousss bea reentrant aan aot anne 4 1 Iistaling tne Batterie Sa csccisecrapseesetarinnnsseanraioxespatontenrevanqitesssteevonaamastt a eienesatsmnnionaieresaveatienconmeaeertenaniase 4 3 BY STAs OI esr E E E R manner 4 4 AC PONG e E E A E E E E E A Sonesta eces tee 4 5 USB Power Universal Serial BUS ssissesissessssasiisirnsssoenosrinresnstninasineesunnesisansairessureia t sa nireser oaran ranenii neinni 4 6 Turning Om th Monl tO sasnnessssmiissinsa aaa 4 7 Checking the Monitor s Configuration sssesssessseesseesseesseesseessecsneeesecenecesecesecesscesscevseesseeoseeoseesseesseeoseeoseeeseee 4 8 Checking the Monitor s Performance sesesesesssessseesseesseesseeoseeeneeoseeeneeeecesecesecesscevscevseesseeoseeoseesseeoseesseeoseeeseee 4 8 Attaching the Sensor to the Patient ssesseessesseessoessessesssesseesecsseeseeoseesseoseossesseesecoserssesseosseoseossesseeseeoseeseess 4 9 Choosing the SUNS OK sas gcrcsostscusesnsss zs basen sete udayest cen aensastateciees arain E Eo Enni Era E SENE raS U KANNAS ES aE ESEON EEAS riR 4 10 BOF OON OF a E EEEE 4 10 Clinician s Operation Manual i Table of Contents Nellcor Sensor WW1020 Only sesesesesssesssesssesssessseesseesseesseesseesseesseeoseeonecoseeoeeoneeosseesseesssesserssersseesss 4 11 Cleaning or Disinfecting the SensSorfS wisicsiessissssssssscaccaniessassssvcaceencast
50. 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 Where the equipment has accidentally gotten wet it should be wiped dry externally and allowed to dry thoroughly before use Before cleaning or disinfecting the printer unplug the AC adapter remove the batteries and remove the paper 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 Chemicals used in some cleaning agents may cause brittleness of plastic parts Follow cleaning instructions in this manual Cleaning with disinfectants including alcohol may shorten the life of the plastic or electronic parts but appropriate disinfection must still be performed Pressing any key with sharp or pointed instruments may permanently damage the keypad Only press keys with your finger Clinician s Operation Manual 1 7 Chapter 1 Introduction Notes NOTE The WW1090 rechargeable battery pack utilizes circuitry that optimizes the charging of the batteries New packs will require multiple charge discharge learning cycles before optimum performance is obtained NOTE SpO averaging means the number of pulse beats over which the SpO value is averaged pulse averaging means the number of seconds over which the pulse value is averaged NOTE Increas
51. for trend memory dump Transfers USB power to the oximeter if no AC is connected only when the USB interface cable WW1089 is connected to an active source of USB power Clinician s Operation Manual 6 1 Chapter 6 Optional Docking Station and Printer Docking Station Figure 6 2 Indicators on Docking Station Front Panel AC Power Indicator This indicator will light when AC power is connected to the Docking Station o USB Power Indicator This indicator will light when a USB cable is connected to the Docking Station but AC power is not Charging Spare Battery Indicator This indicator will flash green when the WW1090 Lithium lon Li rechargeable battery pack is charging 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 Powering the Docking Station WARNING Do not plug the Docking Station AC power supply into an outlet controlled by a wall switch WARNING Do not allow any moisture to contact the AC power supply connectors ora safety hazard may result Ensure that hands are thoroughly dry before handling the AC power supply WARNING Do not place the Docking Station in the patient s bed or crib Do not place the Docking Station on the floor WARNING Failure to place the Docking Station away from the patient may allow the patient to turn off reset or damage the monitor possibly resulting in
52. harging may take 20 hours or more USB power cannot charge the spare Li Rechargeable Battery Pack in the Docking Station NOTE USB power may fail if AC power is interrupted to its PC or powered USB hub Always use charged batteries in the oximeter WW 1090 Lithium lon Li Rechargeable Battery Pack The Docking Station when powered by the WW1095 AC Power Supply will charge two WW1090 Lithium lon Li rechargeable battery packs simultaneously It will recharge the currently installed oximeter battery pack as well a spare pack mounted in the Docking Station battery charger The WW1090 Lithium lon 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 Station battery charger cannot power the oximeter without being installed in the oximeter In the event of loss of power to the Docking Station the spare battery will not automatically provide power Installing the Oximeter to the Dock The WW1020 WW1000 is placed bottom first into the Docking Station facing out as shown in figure 6 3 Confirm that good connection is made by observing that the oximeter s external power indicator is
53. he WW1020 WW1000 pulse oximeter including cable than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz d 0 18 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co i Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 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 as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the WW1020 WW1000 pulse oximeter is used exce
54. he spare Li Rechargeable Battery Pack in the Docking Station 46 Clinician s Operation Manual Chapter 4 Operating Instructions Turning On the Monitor Press this key to turn the monitor on and off Figure 4 6 Turning On the Monitor To turn on the monitor press the key Before using the monitor check the following at power up All LEDs light e The monitor s software revisions main battery PIC oximeter are momentarily displayed e The patient record number is momentarily displayed After a few seconds the SpO 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 error code will display in the SpO gt section See Chapter 9 Troubleshooting for more information Clinician s Operation Manual 4 7 Chapter 4 Operating Instructions Checking the Monitor s Configuration While turning the monitor on hold the yA key until Lr starts to flash then release the key while Lr is flashing to see a list of configuration settings NOTE Ifthe key is held for about 15 seconds or more _ r will stop flashing and TREND DATA WILL BE CLEARED Configuration settings are Auto Shutoff 15 default no
55. iai 6 2 WW1090 Lithium lon Li Rechargeable Battery Pack cssssssssssssssscssececssssssssssssecscessssscseseees 6 3 Installing the Oximeter to the DOCK esesseessesseeseessesssessesssesseessceseesecoseesseoseossesseesscoseeseeosersseoseossesseessee 6 3 Downloading Data to PC ace stsseestseesesesuseresdnclusersstaunsaractinndsd nai NN 6 3 PEI o E E E E EA E E E 6 4 Attaching tne Printe sssaaa NEEE Kra ANE EEEE AAEE EaSE aaan 6 5 Loading PADON no A E E AEA ENEE EEA E 6 6 CTO OST the Print MOOG sswessnssasnussssnnobansro nkara 6 7 Trena Data Condition FLAGS arsseiassierieciiancnnstist dsesnnnnael wattenaonsiatienindmeineanamanamommnimenenuens 6 8 Chapter 7 PC COMMUNICATION SETUP cccscccsssscccssscccsssscccsssscccscsccccscscocecese 7 1 PSS CUO ON OE A OA E A A E E aosonenen 7 1 Power Input and Data Connector Port seesssesssessesssesseeseessesseesseesseoseossesseeseeosceseesseossesseoseesseeseeoseeseesseossesss 7 2 ROW tO SEG Up eC Nt osuiissnnsiiinisiiaiiiei iosa E N STA A 73 STIS OR FZ a2 POT eaaa a E AOSE EA E E EE 7 4 How to Set Up EqUIpMent s esessesseseesesseseessssesseseesessessesesseoresseseoscoseseescosesseseeseosessescosessessesssseeressoseesessesee 7 4 COTE UE La MAG EE N E O A E AES A E E E E E A S 7 5 Chapter 8 Maintenance cccccccsssscocssscccsssscccscsscccssscccescscccssssccsssssccsscscoessess S 1 Routine PIGS AAU CO sec cs escuctsasceuc cesesacaceestnscosszessentes isons qbacysecsesuse
56. ing 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 SpO and pulse rate to the monitor that allows the monitor s performance to be checked NOTE A Patient Simulator cannot be used to assess the accuracy of a pulse oximeter and or sensor 1 8 Clinician s Operation Manual Chapter 2 Intended Use and Monitor Features Chapter 2 Intended Use and Monitor Features Intended Use for the WW1020 Oximeter The BCI WW1020 pulse oximeter is intended for spot checking applications non continuous use It monitors and displays patient s functional oxygen saturation SpO gt 5 pulse rate bpm pulse signal strength and pulse amplitude index PI readings It may be used by physicians respiratory therapists nurses certified nurse assistants emergency medical technicians sleep technicians and home users The intended patient population ranges from neonatal to adult It may be used on patients with low perfusion or during patient motion The WW1020 may be used in the hospital or clinical environment during emergency land transport and in the home WARNING The monitor was not designed or tested to be an apnea monitor Intended Use for the WW1000 Oximeter The BCI WW1000 pulse oximeter is intended to be used for spot checking non continuous use It monitors and display
57. le the monitor should be stored inside at room temperature in a dry environment If it is necessary to store the monitor for an extended period of time the unit should be packed in its original shipping container Storing the monitor for a long period of time may degrade the battery capacity Batteries should be removed from the monitor before storing See Chapter 11 for storage specifications NOTE The monitor may not meet performance specifications when stored or used outside the temperature and humidity ranges listed in Chapter 11 Specifications 8 2 Clinician s Operation Manual Chapter 9 Troubleshooting Chapter 9 Troubleshooting WARNING If the accuracy of any measurement is in question check the patient s vital signs by an alternative method and then check the monitor for proper functioning Power PROBLEM The oximeter doesn t turn on The oximeter turns on but display reads E a Li DAE The oximeter turns off unexpectedly The External Power indicator 1 isnot lit AC Power The External Power indicator gt isnot lit USB Cable The USB Power indicator ef is not lit Docking Station The monitor operates on AC power but not on battery power POSSIBLE CAUSE Batteries weak and or no AC power Batteries not installed or batteries incorrectly installed AC power is connected but no or weak batteries are installed Batteries are weak or dead and no AC power source is conn
58. n apnea monitor and should only be used for spot checking applications non continuous use Following this guide while teaching these tasks may help the instructor and the caregiver Show the home use caregiver how to e Connect the AC Power Supply to a wall outlet e Make sure the AC Power Supply outlet is not controlled by a wall switch e Connect AC Power Supply to the docking station or oximeter e Make sure the monitor s POWER indicator is lit e Visually inspect the sensor and oximetry cable e Connect the sensor to the oximetry cable e Connect the oximetry cable to the monitor e Turn onthe monitor e Perform a pre use check Verify all display LEDs turn on at power up e Route the cable safely from the patient to the monitor to prevent possible patient strangulation e Attach the sensor s prescribed by the doctor e Measure the SpO pulse rate Pl and pulse signal strength bar graph readings e Interpret the Low Battery Signal e Turn off the monitor if appropriate Tell the caregiver how to respond e Incase of a patient emergency including what therapy to provide the patient e Incase the Low Battery Indicator appears e Incase the caregiver has trouble operating the equipment 41600 6 lt SS inician Operation Manual Chapter 5 Patient Record Number and Trend Data Chapter 5 Patient Record Number and Trend Data Description Whenever the WW1020 WW1000 is monitoring a patient it stores an SpO5 a pulse
59. n simulator accuracy specification based on BCI 3026 gt Low Perfusion simulator accuracy specification based on BCI 3044 6 Pulse Amplitude 1 to 0 3 Tested using industry standard simulator Low Perfusion simulator accuracy and specification based on BCI 3178 Clinician s Operation Manual 11 3 Chapter 11 Specifications SpO for the WW1000 Oximeter SpO Range 0 99 Functional Saturation SpO Resolution 1 count SpO3 SpO Averaging 8 beats Calibration Factory calibrated over range 70 to 99 SpO using human blood samples to functional saturation Test methods are available upon request No in service calibration is required Sensors Red 660 nm 2 mW typical Infrared 905 nm 2 2 4 mW typical SpO Accuracy 70 to 99 SpO less than 70 SpO is undefined SpO Accuracy SpO Accuracy BCI Sensor in Normal Conditions in Low Perfusion Conditions 1302 e gt a P 7 3 Arys 1 Because pulse oximeter measurements are statistically distributed only about two thirds of pulse oximeter equipment measurements can be expected to fall within the Agms of the value measured by the CO oximeter E 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 concentrations evenly distributed over an SpO gt range of 70 100 3 Pulse Amplitude 1 to 0 1 Tested using industry standard simulator
60. nea monitor Do not use this device in the presence of flammable anesthetics Do not use this device in the presence of magnetic resonance imaging MR or MRI equipment Operation of this device may be adversely affected in the presence of conducted transients or strong electromagnetic EM or radiofrequency RF sources such as portable and mobile RF communication equipment electrosurgery and electrocautery equipment x rays and high intensity infrared radiation Operation of this device may be adversely affected in the presence of computed tomograph CT equipment Any monitor that has been dropped or damaged should be inspected by qualified service personnel prior to use to insure proper operation 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 This device must be used in conjunction with clinical signs and symptoms This device is only intended to be an adjunct in patient assessment This device is intended for use by persons trained in professional health care or those who have access to the oversight of a professional health care provider The operator must be thoroughly familiar with the information in this manual before using the device Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment
61. necessary 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 SpO reading Optical cross talk can occur when two or more sensors are placed in close proximity It can be eliminated by covering each site with an opaque material Remove fingernail polish or false fingernails before applying SpO sensors Fingernail polish or false fingernails may cause inaccurate SpO readings Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin with CO poisoning or methemoglobin with sulfonamide therapy will affect the accuracy of the SpO measurement Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin porfimer sodium and metatetrahydroxyphenylchlorin mTHPC Change the sensor site at least every hour and observe for signs of tissue damage More frequent sensor site changes inspections may be indicated depending upon the photodynamic agent used agent dose skin condition total exposure time or other factors Use multiple sensor sites Clinician s Operation Manual 4 9 Chapter 4 Operating Instructions Choosing the Sensor WARNING Use only SpO sensors and cables supplied with or specifically intended for use with this BCI oximeter Use of sensors not intended for use with this device may cause inaccurate readings WARNING
62. ng the time varying effects of the pulse in the body tissues 96 SpO2 72 Q Figure 2 1 Theory of Operation Low intensity Red and Infrared LED light sources 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 SpO gt 5 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 oxygen depleted blood WARNING Since measurement of SpO depends on a pulsating vascular bed any condition that restricts blood flow such as the use of a blood pressure cuff or extremes in systemic vascular resistance may cause an inability to determine accurate SpO and pulse rate readings WARNING Under certain clinical conditions pulse oximeters may display dashes if unable to display SpO and or pulse rate values Under these conditions pulse oximeters may also display erroneous values These conditions include but are not limited to patient motion low perfusion cardiac arrhythmias high or low pulse rates or a combination of the above conditions Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury 2 2 Clinician s Operation Manual Chapter 2 Intended Use and Monitor Features Puls
63. nnections AC Power Supply Optional NS Connect AC Power Here Optional Power Input Connector USB Interface USB Interface R Cable to PC Cable Connect USB l Cable to Monitor Figure 7 2 Connecting to a PC using USB Interface Cable 1 Connect the USB interface cable to the O or Power Input Connector on the oximeter or Docking Station 2 If using the WW1095 AC Power Supply connect it to the PC cable power input connector 3 Connect the interface cable to the PC s USB port 4 The oximeter is now ready to download data The BCICP1030 data output format is available upon request NOTE BH Review the PC communication programs instructions to determine how to save the data to the PC Clinician s Operation Manual 7 3 Chapter 7 PC Communication Setup Sensor RS232 Port Trend data may be downloaded in a comma separated value CSV format to a computer s serial RS232 port The following items will be needed e Oximeter e HyperTerminal or other PC communication software e WW3350 Printer Adaptor cable e 3339 PC Adaptor cable Connect to Oximeter Printer Adapter DB 9 Connector Cable REF 3339 vane fri aaa r Connect to IBM E Compatible PC or Printer Cable RF WW3350 Figure 7 3 Connecting to the RS232 Port How to Set Up Equipment Refer to Figure 7 3 for the cable connections 1 Setup the PC communication program to accept the following RS232 data
64. ny excess paper by pulling the paper up toward the front of the printer 7 The printer is now ready to use Figure 6 6D Close Paper Holder Door and Clear Cover 6 6 Clinician s Operation Manual Chapter 6 Optional Docking Station and Printer Choosing the Print Mode Data can be printed in real time numeric trend or graphic trend modes In either trend mode 6 days of previously stored data depending on trend interval collected from 1 to 99 patients can be printed See Chapter 5 Patient Record Number and Trend Data The printer select key sets the printer mode in the oximeter When a new oximeter is installed in the Docking Station it may have a different print format Always check the printer format prior to pushing the start key Change modes by pushing the select key a until the desired mode is lit To start printing push the print 7 key The Print Mode Indicator on the printer will blink green 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 O Real Time Mode prints data every 5 seconds See figure 6 7 1 REALTIME DATA 1p 001 sis hh mm ss SpO2 Rate Title s bpm UUSZO 1 32 Jae To ppr 003726 40 39 7 bpm E Patient Record Number Real time SpO pulse rate and PI values printed every 5 seconds 00 26 45 95 75 bpm 00 26 50 95 75 bpm 00 26 55 95 75 bpm 00 27 00 95 75 bpm 00
65. ocking station See Chapter 6 Optional Docking Station and Printer e The AC power supply can be plugged directly into the oximeter Figure 4 3 e The AC power supply can be plugged into the WW1089 USB Interface Cable Figure 4 4 e The oximeter can be powered by a PC through the USB Interface cable Figure 4 5 Clinician s Operation Manual 4 Chapter 4 Operating Instructions After connecting to power verify that the green External Power Indicator is lit Battery Charge Indicator External Power Indicator UPN s s 0 m Figure 4 1 External Power Charge Indicators If an AC source is present the oximeter will draw power from it first While the oximeter is operating from an AC source the External Power Indicator D will illuminate If there is enough power the WW1090 Lithium lon LI rechargeable battery pack will also charge if installed The battery charge indicator mm1 will display segments showing the charge level As the battery charges 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 is available the oximeter will operate from an ex
66. on Manual A 5 Appendix A Guidance and Manufacturer s Declaration This page is intentionally left blank A 6 Clinician s Operation Manual CE 0473 Authorized Representative as defined by the Medical Device Directive Smiths Medical International Ltd Phone 44 1923 246434 Colonial Way Watford Hertfordshire Fax 44 1923 240273 WD24 4LG UK Australian Representative Smiths Medical Australasia Pty Ltd Tel 61 0 7 3340 1300 61 Brandl Street Eight Mile Plains QLD 4113 Australia MEDICAL EQUIPMENT atal Manufactured By yASSIF e WITH RESPECT TO ELECTRIC SHOCK Smiths Medical PM Inc gt U FIRE AND MECHANICAL HAZARDS ONLY A Dive CA UL JUS IN ACCORDANCE WITH UL60601 1 IEC60601 1 CAN CSA C22 2 NO 601 1 Waukesha WI 53186 1856 USA 21JU
67. one 31 hours for the WW1020 fifty four 54 hours for the WW1000 An easy to read battery gauge indicates the charge level and provides a low battery alert Large bright easy to read LED display indicates SpO and pulse rate measurements e 2Nine segment LED bar graphs indicate pulse signal strength and pulse amplitude index e Optional docking station transforms the device into a table top pulse oximeter and can also be used to recharge the monitor s lithium lon battery pack and a spare battery pack e Optional printer allows for printing of trend information or real time data logs Clinician s Operation Manual 2 1 Chapter 2 Intended Use and Monitor Features Theory of Operation The pulse oximeter determines SpO and pulse rate by passing two wavelengths of low intensity light one red and one infrared through body tissue to a photodetector Information about wavelength range can be especially useful to clinicians Wavelength information for this device can be found in the SpO Specifications section of this manual Pulse identification is accomplished by using plethysmographic techniques and oxygen saturation measurements are determined using spectrophotometric oximetry principles During measurement the signal strength resulting from each light source depends on the color and thickness of the body tissue the sensor placement the intensity of the light sources and the absorption of the arterial and venous blood includi
68. or AMA Clinician s Operation Manual Chapter 4 Operating Instructions Home Use WARNING This device is intended for use by persons trained in professional health care or those who have access to the oversight of a professional health care provider The operator must be thoroughly familiar with the information in this manual before using the device Equipment and Supplies Checklist for Home Use Provide the following to the home use caregiver QUANTITY CAT NO DESCRIPTION 13311 oximeter Cable 1S meters Sfeet Oximetry Sensor Attachments 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 and reference materials QUANTITY DESCRIPTION Scissors for trimming adhesive strips or adhesive tape Appropriate disinfectant and a soft clean cloth or alcohol wipes for disinfecting monitor accessories and reusable sensor Emergency phone numbers for the doctor Emergency phone number for the hospital emergency room Phone number for equipment supplier Quantity prescribed by doctor Clinician s Operation Manual 4 15 Chapter 4 Operating Instructions Training the Home Use Caregiver The home use caregiver must be trained in CPR Inform the caregiver that the oximeter is not to be used as a
69. orized service representative if using LI lon rechargeable battery pack 9 1 Chapter 9 Troubleshooting PROBLEM POSSIBLE CAUSE The monitor displays The battery is defective l l L l er r when powered up Battery run time is excessively short on a fully charged battery Sensor PROBLEM No pulse shown on the bargraph or PI graph The pulse rate is erratic intermittent or incorrect SpO value is erratic intermittent or incorrect The LI lon rechargeable battery pack must be replaced POSSIBLE CAUSE Patient cable or sensor is disconnected from the oximeter Sensor is incorrectly positioned on the patient Poor patient perfusion Defective sensor or patient cable The SpO 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 SpO gt sensor Defective sensor or patient cable Poor patient perfusion Patient motion Defective sensor or patient cable CORRECTIVE ACTION Disconnect the AC power cord and then reconnect it If the error message persists the battery is defective Contact your authorized service representative Contact your authorized service representative CORRECTIVE ACTION Check sensor connections to the patient cable and to the oximeter Reposition the sensor Reposition the sensor Try a new sensor or conta
70. play and W lis displayed This takes about 15 seconds If the key is released at any time before Lr stops flashing the memory is retained and the configuration settings are displayed See Checking the Monitor s Configuration section in Chapter 4 for details Trend Data Output Trend data may be output to a printer or PC See Chapter 6 Optional Docking Station and Printer for information on printing trend data See Chapter 7 Connecting to a PC for information about PC output Clinician s Operation Manual 5 1 Chapter 5 Patient Record Number and Trend Data This page is intentionally left blank Clinician s Operation Manual Chapter 6 Optional Docking Station and Printer Chapter 6 Optional Docking Station and Printer Description Figure 6 1 Docking Station with Printer Attached The WW1025 Docking Station serves many purposes depending on individual needs and selection of optional equipment The Docking Station is powered by the WW1095 AC Power Supply which can power the oximeter and operate the printer while charging the internal and Spare battery packs The Docking Station Provides a convenient and secure home base for the oximeter Recharges WW1090 Lithium lon Li rechargeable battery pack installed in the oximeter Recharges an additional WW1090 Lithium lon Li rechargeable battery pack stored in the Docking Station May be equipped with a WW1026 thermal printer Allows connection to a PC
71. re available at that sample time O Trended SpO pulse rate and PI values print every 4 seconds Clinician s Operation Manual 7 5 Chapter 7 PC Communication Setup This page is intentionally left blank 7 6 Clinician s Operation Manual Chapter 8 Maintenance Chapter 8 Maintenance Smiths Medical PM Inc products have been designed to operate continuously However in order to ensure a continued high level of performance and safety of operation routine maintenance must be performed daily The Oximeter Service Manual REF WW1923 also contains the circuit diagrams parts lists and descriptions required for carrying out repairs The Service Manual is shipped with the monitor Routine Maintenance MAINTENANCE ITEM RECOMMENDED ACTION MAINTENANCE INTERVAL WW1090 Li lon Charge the battery by When Low Battery Signal is rechargeable battery pack connecting AC power to the observed monitor After continuous use under battery power Replace the rechargeable After approximately 300 charge battery pack cycles Monitor Surfaces and Clean and or disinfect As required Docking Station Printer Cables Clean and or disinfect When attaching a new patient Inspect for signs of damage Daily or deterioration replace as required Reusable SpO sensor Clean and or disinfect When attaching a new patient Clinician s Operation Manual 8 1 Chapter 8 Maintenance Cleaning and Disinfecting WARNING Do not autoclave
72. reading Any condition that restricts blood flow such as use of a blood pressure cuff or extremes in systemic vascular resistance may cause an inability to determine accurate pulse rate and SpO readings Optical cross talk can occur when two or more sensors are placed in close proximity It can be eliminated by covering each site with an opaque material Remove fingernail polish or false fingernails before applying SpO sensors Fingernail polish or false fingernails may cause inaccurate SpO readings Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin with CO poisoning or methemoglobin with sulfonamide therapy will affect the accuracy of the SpO measurement Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin porfimer sodium and metatetrahydroxyphenylchlorin mTHPC Change the sensor site at least every hour and observe for signs of tissue damage More frequent sensor site changes inspections may be indicated depending upon the photodynamic agent used agent dose skin condition total exposure time or other factors Use multiple sensor sites When connecting this monitor to any instrument verify proper operation 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 dat
73. rive Fax 262 542 0718 Waukesha WI 53186 1856 Toll Free 800 558 2345 Seller will not be responsible for unauthorized returns or for loss or damage to the Product during the return shipment The repaired or replaced Product will be shipped freight prepaid to Purchaser To obtain warranty information outside of the USA contact your local distributor Keep all original packing material 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 costs incurred returning devices for repair are the responsibility of the shipper CE Notice Marking by the symbol 0473 indicates compliance of this device to the Medical Device Directive 93 42 EEC Authorized Representative as defined by the Medical Device Directive Smiths Medical International Ltd Phone 44 1923 246434 Colonial Way Watford Hertfordshire Fax 44 1923 240273 WD24 4LG UK Australian Representative Smiths Medical Australasia Pty Ltd Tel 61 0 7 3340 1300 61 Brandl Street Eight Mile Plains QLD 4113 Australia vi Clinician s Operation Manual Chapter 1 Introduction Chapter 1 Introduction About the Manual
74. rossi rivais Kisise dirt Ti enUS Ein EA NSN ENERO EEN 8 1 Cleaning and DisiniectiNg msinione 8 2 AOE ara e EEE EA EA AEE O EET 8 2 Chapter 9 Troubleshooting sicescsscscesscssssedscdssccescssssececdssseussessseiecscossessresativesenses J 1 POWO oen E EAE 9 1 S OU E AA 9 2 O a se atnetateteciesamaacemens 9 3 ii Clinician s Operation Manual Table of Contents Chapter 10 Optional Supplies and AcCESSOFICS cccsscccsssscccssssccssescoeses 10 1 Ordering INOA OI aerisire seas scascdadececvncrsscateveupitesdnaseseacsetisrentonaversiesedeasadeantarusenseteetieieuleeneasts 10 2 Chapter 11 Specifications ciscscsisss decsedccccesstcesscssdsessssssseseessiscencesscssnccssesessecsecee 11 1 BE E YS E EINE E ad ora EA OE NE E E EAEE E A EN E 11 1 AESI Eire e EEEE AEN A EE IAE A E E AN EE E A PENNA AE rea A E 11 1 Kays User COntrolS seserepan E E NRSR 11 1 SpO for the WW1020 Oximeter ses sssesssesssessseesseesseesseesseeeseesseeeseeeseceseceseeeseeesecesseeseesseesseesseesseesseesseesseesseess 11 2 Pulse Rate for the WW1020 Oximetef sesessssesssseesseessseessseeosseeoseeesseeesseeosseeosseosseeesseeesseeossessssrosserosseresseess 11 3 SpO for the WW1000 OXIMete f se sesesssesssessseesseesseesseesseesseesseeesecesecesecesseesecesecesseenseesseesseesseenseenseesseessersseess 11 4 Pulse Rate for the WW1000 Oximetef sssessssessssesssseesseesssesssseeoseeesseeesseessseessseosseeosseeosseesssessssrosserosserosseess 1
75. s a patient s functional oxygen saturation SpO gt pulse rate Wbpm pulse signal strength and pulse amplitude index PI readings It may be used by physicians respiratory therapists nurses certified nurse assistants emergency medical technicians sleep technicians clinicians and home users The intended patient population ranges from infant to adult It can be used on patients with low perfusion The WW1000 may be used in the hospital 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 gt 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 WW 1000 e Maintains accurate readings during periods of patient motion WW1020 only and when monitoring patients with low perfusion e Ideally suited for use in hospitals outpatient clinics emergency rooms during emergency land transport in sleep labs or in home use e Portable and lightweight Weighs only 330 grams 12 ounces with 4 AA batteries e On board sensor storage cradle holds the finger sensor when not in use e Power options include four 4 standard AA type IEC LR6 alkaline batteries a rechargeable Lithium lon battery pack USB power or an AC power adapter e Rechargeable battery life for a new battery is approximately thirty
76. stop monitoring CAUTION Use only the interconnect cables specifically intended for use with this device See Chapter 10 Optional Supplies amp Accessories for ordering information Clinician s Operation Manual 4 5 Chapter 4 Operating Instructions USB Power Universal Serial Bus AC Power Supply Optional Connect AC Power Power Input Here Optional Connector USB Interface Cable to PC USB Interface eas Cable aa Connect USB Cable to Monitor Figure 4 5 USB Power to Oximeter The oximeter may be powered from an external USB source such as a laptop computer or powered USB hub The WW1089 USB Interface Cable is a custom cable used to connect the oximeter or docking station to an external computer via its USB port See Chapter 7 Connecting to a PC for more information This port can supply a source of operating power to the oximeter NOTE The WW1090 Lithium lon Li Rechargeable Battery 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 the Battery Pack in the oximeter and connect to USB power Slow charging may take 20 hours or more USB power cannot charge t
77. ternal USB source only when attached to a WW1089 USB Interface Cable and energized USB connection In this case the external power indicator lights If enough power is available the optional WW1090 Lithium lon Li rechargeable battery pack will trickle charge 42000 Clinician s Operation Manual Chapter 4 Operating Instructions Installing the Batteries The oximeter uses four 4 standard AA alkaline IEC Type LR6 cells Figure 4 2A or a custom rechargeable Lithium lon Li battery pack WW1090 Figure 4 2B WARNING Inspect battery terminals for corrosion or contamination The monitor may not operate properly if battery terminals are corroded or contaminated Do not use until battery terminals have been properly cleaned and repaired WARNING Check the expiration date for the batteries The monitor may not operate properly if expired batteries are used Do not use until proper batteries can be obtained WARNING Remove the batteries prior to long term storage WARNING Do not allow the patient to handle the device if the battery door has been E MAEA P Figure 4 2A AA LR6 Alkaline Battery Placement Figure 4 2B Rechargeable Lithium lon Battery Pack To install replace the batteries 1 Depress the battery door tab near the center of the oximeter and slide the cover off toward the bottom of the monitor 2a If using AA LR6 alkaline batteries Install the negative end of each bat
78. tery first compressing the battery terminal spring until the positive terminal clears the positive tab Press the battery down into place NOTE Dispose of spent batteries in compliance with your institution s guidelines and local ordinances 2b If using WW1090 Li lon Li rechargeable battery pack Align the battery pack so that the metal connectors line up with the connectors in the WW1020 WW1000 battery compartment Push the WW1090 Lithium lon Li rechargeable battery pack straight in to place 3 Replace the battery door by sliding the cover back until the latch clicks Clinician s Operation Manual 4 3 Chapter 4 Operating Instructions CAUTION Due to limitations of the Li lon chemistry the rechargeable battery pack should not be charged at ambient temperatures above 45 C 113 F or below 5 C 41 F CAUTION The WW1090 rechargeable battery pack is shipped with only 30 of full charge The battery pack must be charged completely before use CAUTION The WW1090 rechargeable battery pack utilizes Li lon secondary cells Dispose of spent batteries in compliance with your institution s guidelines and local ordinances NOTE The WW1090 rechargeable battery pack utilizes circuitry that optimizes the charging of the batteries New packs will require multiple charge discharge learning cycles before optimum performance is obtained NOTE The rechargeable battery can be charged in the oximeter or in the spare bay of th
79. 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 Docking Station s AC power indicator CT will light when AC power is connected The Docking Station has built in intelligence that prioritizes available power to the oximeter printer and chargers If USB power is used for the Docking Station some accessories may not operate When the WW1089 USB interface cable is connected to the Docking Station data can be transferred from the oximeter s data port through the Docking Station to a compatible device If the USB cable is used without AC power the USB A indicator is lit and USB power is available to the oximeter NOTE The WW1090 Lithium lon Li Rechargeable Battery 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 6 2 Clinician s Operation Manual Chapter 6 Optional Docking Station and Printer NOTE To slow charge the WW1090 Lithium ion Li Rechargeable Battery Pack install the Battery Pack in the oximeter and connect to USB power Slow c
80. the plastic or electronic parts but appropriate disinfection must still be performed 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 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 Oximetry Extension Cables are connected together WARNING Misuse or improper handling of the sensor and cable may result in damage to the sensor This may cause inaccurate readings 1 Before the sensor is attached check the integrity of the sensor and cable 2 If not using the oximetry extension cable connect the sensor to the oximeter Push the sensor s connector firmly into the oximeter If using the oximetry extension cable connect the sensor to the cable and the cable to the oximeter Push the cable connector firmly into the oximeter 3 Make sure the red light in the sensor is illuminated 4 Now the sensor can be attached to the patient WARNING If any of the integrity checks fail do not attempt to monitor the patient Use another sensor or oximetry extension cable or contact the authorized
81. to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 Mhz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A 4 Clinician s Operation Manual Appendix A Guidance and Manufacturer s Declaration The following is a list of cables transducers and accessories used with the WW1020 WW1000 pulse oximeter WARNING Use of accessories transducers and cables other than those specified below may result in increased emissions or decreased immunity of the systems BCI Accessories CAT NO DESCRIPTION WW1026 Printer Must be used with Docking Station WW1025 Sensor Oximetry Wrap Infant 3 15 kg Sensor Oximetry Wrap Neonate Small Infant lt 3 kg Sensor Oximetry Universal Y The BCI 1302 and 3026 oximetry sensors should not be used on neonatal patients with the WW1000 monitor Testing has not been conducted for the WW1000 for patients less than 30 days old These sensors may however be used on older patients WARNING The WW1020 WW1000 pulse oximeter should not be used adjacent to other medical equipment If such use is necessary the system should be observed to verify normal operation in the configuration it will be used Clinician s Operati
82. tures Front Display The display shows the measurements for SpO gt and Pulse Rate It also shows a pulse strength indicator a pulse amplitude indicator and indicators for AC power and battery charge level ams oSpOo B07 Figure 3 1 Front Display Pulse Amplitude Index Bar Graph green yellow The pulse amplitude index bar graph is used to assist the operator in locating the oximetry sensor site with the best pulse signal strength A higher bar graph indicates a better quality site The bottom 2 bars turn yellow to indicate that the oximeter is receiving a low signal quality from that sensor site External Power Indicator D green This indicator is lit when the device is receiving power from the AC adapter or USB cable 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 4 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 is lit and flashing yellow the batteries will expire within minutes replace the batteries NOTE This indicator is OFF if AA batteries are installed and D is illuminated SpO Numeric Display red A number shows the patient s functional oxygen saturation value in percent Dashes
83. ximeter to lose its ability to obtain readings A different sensor site should be considered The PI value approximately maps to a 9 segment bar graph as shown below The two lowest bars 1 and 2 are bi color yellow and green and bars 3 through 9 are green WM 10 24 20 47 H gt 102 WM 5 12 10 23 WH gt 5 0 10 2 WM 256 511 H 2 6 5 0 WH 28 255 WE 2 26 PI W iy PI WH 6 a HH 0 32 0 63 WI 0 4 0 6 WR 0 16 0 31 W 02 04 W 0 08 0 15 W gt 0 0 2 HI 0 00 0 07 W 0 00 For the WW1020 Oximeter For the WW1000 Oximeter NOTE The PI value is a relative value that varies from patient to patient 41200 Glinician s Operation Manual Chapter 4 Operating Instructions When placing the sensor on the patient allow the cable to lay across the top of the hand and parallel to the arm of the patient as shown in Figure 4 8 Figure 4 8 Positioning the Cable of the Finger Sensor Sensor finger sensor shown for illustration only Cable Clinician s Operation Manual 4 13 Chapter 4 Operating Instructions Storing the Sensor Upon completion of patient monitoring detach the sensor and loosely coil the finger sensor cable Store the sensor in the Sensor Storage cradle or other safe place when not in use Use the proper cradle Three different sensor cradles are available for this oximeter CRADLE SENSOR TYPE Sensor Sensor Cradle Oximeter Figure 4 9 Attaching the Sensor and Sensor Cradle to the Monit

SPECTRO2 10 Pulse Oximeter Hand-Held Manual

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