Smiths Medical Oxi-Pulse 30 Home Use Operation Manual Download Page 66

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Authorized Representative (as defined by the Medical Device Directive):

Smiths Medical International Ltd.

Colonial Way, Watford, Hertfordshire,

WD24 4LG, UK

Phone: (44) 1923 246434

Fax: (44) 1923 240273

Australian Representative:
Smiths Medical Australasia Pty. Ltd.

61 Brandl Street, Eight Mile Plains,

QLD 4113, Australia

Tel: +61 (0) 7 3340 1300

Smiths Medical PM, Inc.
N7W22025 Johnson Drive
Waukesha, WI 53186-1856 USA

MEDICAL EQUIPMENT

WITH RESPECT TO ELECTRIC SHOCK,

FIRE AND MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH UL60601-1, IEC60601-1,

CAN/CSA C22.2 NO. 601.1

21JU

Summary of Contents for Oxi-Pulse 30

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Page 3: ... 3 3 Chapter 4 Controls and Features 4 1 Monitor Front View 4 1 Front Display 4 2 Monitor Operating Keys 4 3 Monitor Back and Bottom Panels 4 4 Chapter 5 Operating Instructions 5 1 Powering the Oximeter 5 1 Installing the Batteries 5 3 External Power 5 4 AC Power 5 5 USB Power Universal Serial Bus 5 6 Turning On the Monitor 5 7 Checking the Monitor s Performance 5 8 Attaching the Sensor to the Pat...

Page 4: ...on 7 2 WW1090 Lithium Ion Li Rechargeable Battery Pack 7 3 Installing the Oximeter to the Dock 7 3 Downloading Data to PC 7 3 Printer 7 4 Attaching the Printer 7 5 Loading Paper 7 6 Choosing the Print Mode 7 7 Trend Data Condition Flags 7 8 Chapter 8 Maintenance 8 1 Routine Maintenance 8 1 Cleaning and Disinfecting 8 2 Storage 8 2 Chapter 9 Troubleshooting 9 1 Correcting an Alert Condition 9 1 Pow...

Page 5: ...096 BCI Comfort Clip Oxi Pulse 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 ...

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Page 7: ... 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 Pulse Signal Strength Bar Graph The pulse signal strength bar graph sweeps with the patient s pulse beat The height of the bar graph is a l...

Page 8: ...on LED AC Power Docking Station LED USB Power Docking Station LED Charging Spare Battery Printer icon Parameter Alarm Printer icon Artifact Printer icon Small Pulse Printer icon Check Sensor Printer icon Searching too Long Printer icon Lost Pulse 7 Do not reuse One use on one patient K Moisture Sensitive 1 Not suitable for use in the presence of a flammable anesthetic mixture D Output Voltage Conn...

Page 9: ...overy 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 keyword definition WARNING Something that could hurt the patient or hurt the operator CAUTION Something that could damage the monitor...

Page 10: ...of a professional health care provider The operator must be thoroughly familiar with the information in this manual before using the device WARNING You must be able to hear the monitor s alarms Whenever the patient is being monitored you must be close enough to hear the sound of an alarm or an alert WARNING Do not sleep in the same bed as the monitored patient WARNING Prolonged use or the patient ...

Page 11: ...ysfunctional hemoglobins such as carboxyhemoglobin with CO poisoning or methemoglobin with sulfonamide therapy will affect the accuracy of the SpO2 measurement WARNING 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 f...

Page 12: ... WARNING Do not allow the patient to handle the device if the battery door has been removed except while installing new batteries WARNING Disconnect the external power supply from the monitor or Docking Station before disinfecting or cleaning the monitor WARNING Do not plug the monitor or Docking Station into an outlet controlled by a wall switch WARNING Disconnect the AC power supply from the out...

Page 13: ...ive for help WARNING Use only the power supply included with your monitor or approved by Smiths Medical PM Inc Use of an inappropriate power supply may cause a patient shock hazard or cause the oximeter to stop monitoring See Chapter 10 Optional Supplies Accessories for additional specific information WARNING The Docking Station must have a Printer or Printer Port Cover installed Failure to do so ...

Page 14: ...y direction when replacing batteries CAUTION Do not allow water or any other liquid to spill onto the monitor or Docking Station Do not autoclave ethylene oxide sterilize or immerse the monitor or Docking Station in liquid Evidence that liquid has been allowed to enter the monitor or Docking Station voids the warranty CAUTION Where the equipment has accidentally gotten wet it should be wiped dry e...

Page 15: ...ate rate NOTE Alarm limits are retained through power cycles with the exception of the following note NOTE If the low SpO2 limit is set to less than 85 it will be reset to 85 when the monitor is next powered on The high SpO2 limit will be adjusted to 86 if it is 85 or less NOTE If the alarm volume is set to a value less than 8 at power down it will be reset to 8 when the monitor is next powered on...

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Page 17: ...e in hospitals outpatient clinics emergency rooms during emergency land transport in sleep labs or in home use Portable and lightweight Weighs only 330 grams 12 ounces with 4 AA batteries On board sensor storage cradle holds the finger sensor when not in use Power options include four 4 standard AA type IEC LR6 alkaline batteries a rechargeable Lithium Ion battery pack USB power or an AC power ada...

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Page 19: ...025 Docking Station optional 1 WW1090 Li Ion rechargeable battery pack optional 1 3311 Oximeter Cable 1 5 m 5 feet Oximetry Sensor Oximetry Sensor Attachments 1 WW1924HU WW1030 Home Use Manual 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 ne...

Page 20: ...ensor to the oximetry cable Connect the oximetry cable to the monitor Turn on the monitor Perform a pre use check Verify all display LEDs turn on and the monitor beeps at power up Route the cable safely from the patient to the monitor to prevent possible patient strangulation Attach the sensor s prescribed by the doctor Measure the SpO 2 pulse rate PI and pulse strength bar graph readings Turn off...

Page 21: ... this manual before using the device While the monitor is in Home Mode The Alarm Menu settings including alarm limits and alarm volume may be viewed but changes cannot be made The Clinician Menu is not accessible The Setup Menu is not accessible Trends cannot be cleared Averaging remains in the previously set state Patient record number advancement is disabled Trend data is identical to Clinician ...

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Page 23: ... Alarm Indicator The alarm indicator lights yellow during low priority conditions flashes yellow during medium priority conditions and flashes red during high priority conditions Keys The keys located on the front panel control the monitor s functions The ON OFF key is located on the side panel WARNING Pressing front panel keys with sharp or pointed instruments may permanently damage the keypad Pr...

Page 24: ...e signal strength bar graph sweeps with the patient s pulse beat The height of the bar graph is a logarithmic representation of the pulse signal strength Battery Charge Indicator green yellow if low The battery charge indicator shows the current state of charge of the installed battery LED segments will disappear as the battery becomes weaker When only one LED is lit and flashing yellow the batter...

Page 25: ...u system and to advance to the next menu selection Cancel Exit Key Press this key to exit the menu system n Up and o Down Arrows Use the up and down arrow keys to adjust pulse beep volume during normal operation In a menu use these keys to adjust the selection x ON OFF Key Momentarily press this key when the device is OFF to turn the monitor ON Press and hold the Exit key while pressing the On OFF...

Page 26: ...rom this connector using an RS232 serial interface cable Sensor Storage Slot Reusable BCI sensors can be securely stored here when not in use by using a WW1080 Sensor Cradle Battery Compartment This compartment holds the disposable batteries or the rechargeable battery pack Data Input Output or Power Input Connector This connector can accept the AC power adapter or the USB cable The docking statio...

Page 27: ...030 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 or may fail to alarm in the case of external power failure The WW1030 oximeter can obtain external power in the following ways The oximeter can be ...

Page 28: ...r 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 30 minutes of charge left that segment will flash and the low battery alert will sound See the Low Battery Signal s...

Page 29: ...door has been removed except while installing new batteries To install replace the batteries Depress the battery door tab near the center of the oximeter and slide the cover off toward 1 the bottom of the monitor 2a If using AA LR6 alkaline batteries Install the negative end of each battery first compressing the battery terminal spring until the positive terminal clears the positive tab Press the ...

Page 30: ...ety 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 r...

Page 31: ... power supply intended for use with this monitor Use of an inappropriate power supply may cause a patient shock hazard or cause the oximeter to stop monitoring See Chapter 10 Optional Supplies Accessories for information CAUTION Use only the interconnect cables specifically intended for use with this device See Chapter 10 Optional Supplies Accessories for ordering information AC Power Supply Power...

Page 32: ...harged 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 oxi...

Page 33: ...r for Clinician Mode SLP for Sleep Mode H for Home Mode After a few seconds the SpO2 value pulse rate pulse signal strength and PI bar graphs should be shown If not see Chapter 9 Troubleshooting for help WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device WARNING Verify that the monitor sounds a short tone upon startup of the device If no tone is h...

Page 34: ... 8 at power down it will be reset to 8 when the monitor is next powered on 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 SpO2 and ...

Page 35: ... be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary WARNING Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine patent blue V PBV and fluorescein may adversely affect the accuracy of the SpO2 reading WARNING Optical cross talk can occur when two or more sensors are placed in clos...

Page 36: ...CI Sensors patient site description Adult over 45 kg Finger Finger or Toe Ear 3044 Sensor Reusable Adult 3444 Sensor Reusable Comfort Clip 3043 Sensor Reusable Universal Y 1300 Sensor Disposable Adult Finger 7 WW3078 Sensor Reusable Ear Pediatric 15 45 kg Finger Finger or Toe Ear 3044 Sensor Reusable Adult 20 kg 3444 Sensor Reusable Comfort Clip 3178 Sensor Reusable Pediatric Finger 5 45 kg 3043 S...

Page 37: ...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 or could fail to alarm if multiple Oximetry Extension Cables are connected together WAR...

Page 38: ...ile 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 ...

Page 39: ...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 1 Should be used for BCI pediatric size finger sensors 2 Should be used for the 3444 Comfort Clip sensor 3 Should be ...

Page 40: ...with each pulse beat The volume of the beep can be adjusted to fifteen 15 settings and off This setting is retained at power down power up To adjust the volume to the off setting press and hold the down arrow o From the off setting set the volume by pressing the up arrow n The volume is changed with each key press ...

Page 41: ...st priority alarm is displayed For example if a patient alarm high priority is active at the same time as a remote alarm cable fault medium priority the remote alarm cable fault will not be displayed The following is an exception to this general rule During a low battery alarm medium priority the low battery indicator in the battery gauge will always flash even if the other alarms are active NOTE ...

Page 42: ...during the two minute pause solid for the first minute and 45 seconds flashing for the final 15 seconds To cancel the two minute alarm tone silenced condition momentarily press the Alarm Silence button B the alarm silenced indicator turns off Visual indications of alarms are not affected by the Alarm Silence button The parameter numbers battery indicator LEDs and the beacon will continue to flash ...

Page 43: ...ced The high priority alarm tone consists of two bursts of five tones each repeated every 7 seconds The numeric display of each exceeded parameter flashes twice per second During a lost pulse condition pulse rate and SpO2 displays will flash The Alarm Indicator flashes red twice per second Each time new trend data is saved it is marked with an alarm active flag The alarm condition is sent to the d...

Page 44: ...in the monitor s battery WARNING When the Low battery indicator flashes charge or replace the monitor s battery Otherwise the monitor turns itself off about 10 minutes after the yellow segment begins to flash There are four green LED segments in the battery charge display on the oximeter When all four are lit the battery is fully charged As the charge is used fewer bars will be lit When the charge...

Page 45: ...ingle tone pair of beeps with a 20 second pause The Alarm Indicator lights yellow Each time new trend data is saved It is marked with an alert active flag The alarm condition is sent to the data output port Alarms active at the time of a real time data output are indicated on the optional WW1026 thermal printer Alarm Summary Type Display Indicator Alarm Indicator Effects Audio High Priority Alarms...

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Page 47: ...for the WW1030 oximeter Recharges WW1090 Lithium Ion Li rechargeable battery pack installed in the oximeter Recharges an additional WW1090 Lithium Ion Li rechargeable battery pack stored in the Docking Station May be equipped with a WW1026 thermal printer Allows connection to a PC for trend memory dump or real time data transmission Transfers USB power to the oximeter if no AC is connected only wh...

Page 48: ...ation away from the patient may allow the patient to turn off reset or damage the monitor possibly resulting in the patient not being monitored Make sure the patient cannot reach the monitor from their bed or crib The WW1095 AC Power Supply provides power to the Docking Station and connected accessories Connect the AC Power Supply to the dock using the data port or Power Input Connector The Dockin...

Page 49: ...on battery charger The WW1090 Lithium Ion Li rechargeable battery pack is placed in the dock as shown in figure 7 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 7 3 Connecting the Rechargeable Battery Pack NOTE The...

Page 50: ...at print mode is selected See Choosing the Print Mode section later in this Chapter The Print Mode Indicator will blink green when printing is pending or in progress Start Stop Print Key Press this key to start or stop printing Print Error Indicator This indicator will light if there is an error in printing Select Print Mode Key Press this key to change the print mode 1 2 3 4 1 2 3 4 ...

Page 51: ...ter and battery from the Docking Station prior to installing the printer will result in an error which may cause a faulty printout Remove the Docking Station printer port 2 cover Hook the tab on the top of the printer 3 to the groove at the top of the Docking Station Then swing the printer down to align and attach the printer to the dock s electrical connectors Install the screw as shown in figure...

Page 52: ...ing information To load the paper follow the steps illustrated below Remove existing spool if present 3 Place paper spool in holder so that 4 the paper exits over the top of the roll and drapes over the rubber roller as shown in figure 7 6C Close the paper holder door and the clear 5 cover Tear off any excess paper by pulling the 6 paper up toward the front of the printer Figure 7 6A Release Print...

Page 53: ...figure 7 7 Mode 2 Numeric Trend Data prints in a tabular form See figure 7 8 1 2 3 4 2008 JUN 22 REALTIME DATA ID 002_____________________ hh mm ss SpO2 Rate PI bpm 18 38 15 97 77 bpm 4 9 18 38 20 97 76 bpm 5 6 18 38 25 97 77 bpm 5 4 18 38 30 95 72 bpm 5 1 18 38 35 94 70 bpm 4 9 18 38 40 95 69 bpm 4 0 18 38 45 96 71 bpm 3 0 18 38 50 96 72 bpm 2 9 18 38 55 96 73 bpm 2 9 Date when the printout was s...

Page 54: ...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 Parameter Alarm Indicates a parameter has met or exceeded its alarm limit Artifact Artifact indicator informs user of excess motion noise or other signal information that the algorithm interprets as potentially non p...

Page 55: ...l is shipped with the monitor Routine Maintenance Maintenance Item Recommended Action Maintenance Interval WW1090 Li Ion rechargeable battery pack Charge the battery by connecting AC power to the monitor Replace the rechargeable battery pack When Low Battery Signal is observed After continuous use under battery power After approximately 300 charge cycles Monitor Surfaces and Docking Station Printe...

Page 56: ...ally 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...

Page 57: ...an alert Ensure the sensor oximetry cable and oximeter connectors are all firmly seated 1 Ensure the sensor is properly attached to the patient See 2 Attaching the Sensor to the Patient section in Chapter 5 Operating Instructions for help Ensure the tape used to hold the sensor is not wrapped too tightly Wrapping the tape too 3 tightly may prevent the monitor from measuring SpO2 and pulse rate Che...

Page 58: ...itor 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 Check all power supplies and cables for proper connections Only connect the AC power cord to an outlet that is not controlled by a wall switch Contact your authorized service representative The Ex...

Page 59: ...n the patient Poor patient perfusion Defective sensor or patient cable Check sensor connections to the patient cable and to the oximeter Reposition the sensor Reposition the sensor Try a new sensor or contact your authorized service representative for help The pulse rate is erratic intermittent or incorrect The SpO2 sensor is improperly positioned on the patient The patient is experiencing poor pe...

Page 60: ... signal bar graphs Check sensor connections to the patient cable and to the oximeter Reposition the sensor on the patient Printer and Data Communication PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION No printout on optional printer AC power is not connected to the Docking Station No trends in memory No paper or paper incorrectly loaded Connect AC Power to the Docking Station Take trend data See Chapter ...

Page 61: ...s erroneous values Clock battery disconnected or discharged Contact your authorized representative Display shows sr ERR No sensor attached to the oximeter Defective sensor or patient cable Attach a sensor to the oximeter Try a new sensor If the problem persists contact your authorized service representative Display shows 24 ERR EEPROM checksum Error Contact your authorized service representative D...

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Page 63: ...ger 10 box 1301 Sensor Oximetry Disposable Pediatric Finger 15 45 kg 10 box 1302 Sensor Oximetry Disposable Neonate 3 kg 10 box 1303 Sensor Oximetry Disposable Infant 3 15 kg 10 box 1606 Simulator Oximeter each WW1924X1 Manual Operation each WW1924X1HU Manual Home Use each WW1925X1 Manual Service each 3025 Sensor Oximetry Wrap Infant 3 15 kg each 3026 Sensor Oximetry Wrap Neonate 3 kg each 3043 Se...

Page 64: ...Chapter 10 Optional Supplies and Accessories 10 2 Home Use Operation Manual Ordering Information For ordering information contact your local distributor ...

Page 65: ......

Page 66: ...x 44 1923 240273 Australian Representative Smiths Medical Australasia Pty Ltd 61 Brandl Street Eight Mile Plains QLD 4113 Australia Tel 61 0 7 3340 1300 H Smiths Medical PM Inc N7W22025 Johnson Drive Waukesha WI 53186 1856 USA MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 IEC60601 1 CAN CSA C22 2 NO 601 1 21JU ...

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