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Clinical Study

134

Operator’s Manual

Adverse Events or Deviations

The study was conducted as expected with no adverse events and no deviations
from the protocol.

Conclusion

The pooled results indicate that for a saturation range of 60-80% for SpO

, the

acceptance criterion was met for the monitoring system when tested with MAX-A,
MAX-N and MAX-FAST sensors. The pooled results indicate that for a saturation range
of 70-100% for SpO

, the acceptance criterion was met.

Содержание Nellcor OxiMax N-600x

Страница 1: ...Operator s Manual Nellcor N 600x Pulse Oximeter Alarm Management System OximaxTM Technology TM...

Страница 2: ...3 310 6 591 123 6 708 049 7 016 715 7 039 538 7 120 479 7 120 480 7 142 142 7 162 288 7 190 985 7 194 293 7 209 774 7 212 847 7 400 919 To obtain information about a warranty if any contact Covidien T...

Страница 3: ...m Management Feature 13 Pulse Rate Delay Alarm Management Feature 17 Oximeter Display View Options 17 General Care Format GCF Display 17 Plethysmographic Pleth Display 18 Blip Display 18 Real Time Tre...

Страница 4: ...the SatSeconds Alarm Management Feature 58 Chapter 5 Managing Oximetry Data 61 Managing Oximeter Trend Data 61 Trend Data Basics 61 Reading the Trend Data Display 62 Storing Trend Data 65 Clearing Tr...

Страница 5: ...ror Codes 103 Prompts and Error Messages 103 Primary Speaker Failure 107 Low and Critical Battery Conditions 109 Obtaining Technical Assistance 112 Returning your Oximeter 112 Chapter 9 Oximeter Maint...

Страница 6: ...s 122 Measurement Range 122 Product Compliance 124 Product Standards for Compliance 124 Product Safety Standards 124 Electromagnetic Compatibility EMC Standards 124 Manufacturer s Declaration 125 Basi...

Страница 7: ...shown above Notes are listed before or after procedural steps or information and provide additional guidelines or information on the subject being described Warnings WARNING The OxiMax pulse oximetry...

Страница 8: ...not touch broken LCD panels Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances WARNING Do not silence or decrease the volume of the OxiMax N 600x puls...

Страница 9: ...IEC Standard 60601 1 1 2000 Requirements for Medical Electrical Systems Anyone connecting additional equipment to the signal input port or signal output port data port connector is configuring a medi...

Страница 10: ...Safety Information 4 Operator s Manual Page Left Intentionally Blank...

Страница 11: ...eter s OxiMax SPD Alert SPD feature is possible Intended Use The Nellcor N 600x Pulse Oximetry System with N 600x Pulse Oximeter and Nellcor Sensors and Cables with OxiMAX technology is indicated for...

Страница 12: ...information change alarm limits adjust the internal time clock select the communications protocol and choose the interface language native to the language of the facility caregiver or user See Using...

Страница 13: ...ation and alarm volume The ALARM SILENCE key clears SENSOR OFF LOW BATTERY and SENSOR DISCONNECT Table 2 List of Front Panel Components 1 SpO2 Sensor Port 14 ADJUST UP DOWN Keys 2 Low Battery Indicato...

Страница 14: ...nu functions Oximeter Visual Indicators AC Power Indicator Lights continuously when connected to an AC power source and also shows when the battery is charging Does not light when the oximeter is runn...

Страница 15: ...s of pulse alarms and when the pulse rate is outside of the alarm limits During Pulse Search the oximeter continues to update the display Pulse rates outside of the pulse rate range of 20 to 250 bpm a...

Страница 16: ...s are set to neonate limit values but not when set to adult limit values For more information about using the feature reference To set adult or neonatal modes page 52 Monitoring Values WARNING Failure...

Страница 17: ...Medium pitched pulsing tone indicates an SpO2 or pulse rate limit violation Note If a Medium Priority Alarm is not silenced within two minutes by pressing the ALARM SILENCE key the oximeter increases...

Страница 18: ...Warning See Instructions for Use Fuse replacement Equipotential terminal ground Date of manufacture Data interface Proper WEEE Waste Disposal Type BF applied part Not defibrillator proof Table 4 Rear...

Страница 19: ...wed by a resaturation The SPD feature qualifies patterns of desaturation resulting from such repetitive reductions in airflow based on specific characteristics The severity of the desaturation event t...

Страница 20: ...alarm sounds each time it violates the alarm threshold SatSeconds monitors both degree and duration of desaturation as an index of desaturation severity Thus the SatSeconds feature helps distinguish c...

Страница 21: ...Oximeter Features Operator s Manual 15 Figure 6 Second SpO2 Event No SatSeconds Alarm...

Страница 22: ...elow the limit long enough for the SatSeconds time setting to be reached When three or more limit violations occur within 60 seconds an alarm sounds even if the SatSeconds time setting has not been re...

Страница 23: ...Delay limit controls the time the pulse rate level crosses either limit before an audible alarm sounds Reference Oximeter Display View Options page 17 Managing the View Display page 33 Using the Pulse...

Страница 24: ...on reference Managing the View Display page 33 Blip Display Figure 10 Blip Display View Use this display view for visual monitoring information in blip bar form The blip display includes a pulse ampli...

Страница 25: ...nd or pulse rate trend data plots current measured SpO2 and pulse rates It also includes a battery fuel gauge if running on battery power Each time the oximeter detects a pulse the heart icon flashes...

Страница 26: ...General Introduction 20 Operator s Manual Page Left Intentionally Blank...

Страница 27: ...etic fields created by MRI equipment Also induced currents could potentially cause burns WARNING To ensure accurate performance and prevent device failure do not subject the OxiMax N 600x pulse oximet...

Страница 28: ...jacent or stacked use is necessary observe the oximeter to verify normal operation in the desired configuration Note The OxiMax N 600x pulse oximeter incorporates watchdog timers which reset the oxime...

Страница 29: ...visible to the user from AC power to battery power or from battery power to AC power A new fully charged battery provides approximately seven hours of monitoring time under certain conditions Pulse si...

Страница 30: ...oximetry sensor or the sensor is disconnected from the oximeter the oximeter cannot detect data No alarms are present other than low battery or a non correctable error Note Whenever the oximeter is c...

Страница 31: ...ed to IEC 60601 1 1988 A1 1991 A2 1995 EN60601 1 1990 A11 1993 A12 1993 A13 1996 and the Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful i...

Страница 32: ...equipment in the vicinity off and on to isolate the offending equipment 2 Reorient or relocate the interfering equipment 3 Increase the separation between the interfering equipment and the oximeter T...

Страница 33: ...se of mechanical or functional damage contact Nellcor s Technical Services Department at 1 800 635 5267 or your local Nellcor representative Monitoring Oximeter Power Battery Fuel Gauge Any time the o...

Страница 34: ...n a low priority alarm and a lighted low battery indicator Ensure that the switch setting matches your AC voltage The Low Battery Indicator lights and a low priority alarm begins to sound when approxi...

Страница 35: ...ble and an OxiMax pulse oximetry sensor attached the unit is ready to register and record patient trend data Note Physiological conditions medical procedures or external agents such as dysfunctional h...

Страница 36: ...corresponding number See Troubleshooting page 99 Figure 16 Error Condition Screen Battery Failure Note Physiological conditions medical procedures or external agents that may interfere with the monito...

Страница 37: ...of another pulse oximetry cable will have an adverse effect on performance Do not attach any cable that is intended for computer use to the SpO2 sensor port WARNING Use only Nellcor approved OxiMax p...

Страница 38: ...audible indicator of the real time patient data Caution If the pulse beep tone does not sound with each pulse the pulse beep volume is set to zero the speaker is malfunctioning or the signal is corru...

Страница 39: ...al time data Reference Oximeter Display View Options page 17 for details Selections last until power cycle or until manual selection of another view Using the General Care Format GCF Display General C...

Страница 40: ...ry fuel gauge appears in the upper left corner of the display To select the GCF Display 1 With the oximeter in the normal monitoring mode press the SETUP softkey 2 Press the VIEW softkey 3 Press the N...

Страница 41: ...ttery When using the internal battery a battery fuel gauge appears in the upper left corner of the display To select the Pleth Display 1 With the oximeter in the normal monitoring mode press the SETUP...

Страница 42: ...2 Press the VIEW softkey 3 Press the BLIP softkey Figure 21 Blip Display View Using the Real Time Trend Display Real Time Trend Display Overview Use this display view for visual monitoring information...

Страница 43: ...ture is activated and the SPD feature is enabled For more information about activation contact Nellcor s Technical Services Department at 1 800 635 5267 or your local Nellcor representative For more i...

Страница 44: ...he pulse trend data Figure 25 Pulse Trend Data 30 minute To set up the Trend Time Scale Display 1 Press the SETUP softkey 2 Press the VIEW then NEXT softkeys 3 Press the TREND softkey 4 Press the ZOOM...

Страница 45: ...ived from the sensor To adjust the pulse beep volume 1 With the oximeter in the normal monitoring mode press and hold the ADJUST UP key below the ALARM SILENCE key on the oximeter panel to increase th...

Страница 46: ...eleasing the ADJUST UP or ADJUST DOWN key sets the alarm silence duration Note Default alarm silence duration is 60 seconds Select the appropriate value for the situation The alarm silence duration ad...

Страница 47: ...sable the alarm messages Figure 28 Standby Mode The oximeter is now in the standby mode Reconnect the sensor to the oximeter and the patient to return to normal monitoring Using Oximeter Softkey Menus...

Страница 48: ...unication port the nurse call feature and control analog voltage 4 LIGHT Menu Leave the display backlight on adjust brightness or choose to turn the display backlight off LIMITS Menu Figure 30 Limit M...

Страница 49: ...lue This setting only holds until power recycle Decimal points to the right of the displayed values indicate those limits have been modified from the power on default values See Adjusting the Factory...

Страница 50: ...en set to PAU can register amplitudes up to 200 PAU b ZOOM Menu Access to the TIME option SCALE option AUTO option and BACK option if the trend view is set in DUAL SpO2 or PULSE mode Note The ZOOM men...

Страница 51: ...trend data Isolate oxygenation SpO2 Option or pulse PULSE Option trend data or viewing them both together DUAL Option ZOOM softkey Access to the TIME Option SCALE Option AUTO Option and BACK Option i...

Страница 52: ...ss the NEXT softkey c Press the CLOCK softkey d Press the SET softkey e Press the SELECT softkey to select the TIME and DATE fields as shown TIME HOURS MINUTES SECONDS DATE DAY MONTH YEAR Figure 31 Ti...

Страница 53: ...e SETUP menu press the NEXT softkey twice Use the SELECT softkey to toggle between the baud rate and communication protocol Arrow up or down to select the proper baud rate Baud rates include 19200 960...

Страница 54: ...e however may impact the SPD alarm behavior From the SETUP menu press the NEXT softkey twice to reach the MODE menu option a Normal Mode Default response mode responds to changes in blood oxygen satur...

Страница 55: ...iate for the patient being monitored WARNING The SPD feature is for use with adults patients only In Neonate Mode the SPD feature remains OFF Caution Use of the SPD alarm feature does not change the n...

Страница 56: ...ttempt to save either of these values as default results in an invalid tone These limits can be adjusted lower for the current patient but return to power on defaults at power off Note The SPD feature...

Страница 57: ...t Midrange Display Format GCF Backlight Brightness 8 Battery Power 10 AC Power Language English Pulse Beep Volume 4 of 10 Pulse Rate Lower Alarm Limit 40 BPM 90 BPM Pulse Rate Upper Alarm Limit 170 BP...

Страница 58: ...ATE LIMITS screen based on institutional or default settings a The adult limits screen displays the institutional or factory default settings appropriate to adult and pediatric patients Figure 34 Sett...

Страница 59: ...d the Limit display also includes the SatSeconds and SPD icons Note Limit changes remain in effect as long as the oximeter power continues but return to the institutional default limits when oximeter...

Страница 60: ...period of time may cause a progressive drop in alveolar partial pressure of oxygen leading to arterial desaturation If these decreases in ventilation are repetitive they generate distinct patterns in...

Страница 61: ...iangle empties from top to bottom as the patterns become less severe If the triangle fills an alarm sounds With SPD enabled the default setting is On with the sensitivity set to 1 The feature can be t...

Страница 62: ...alarms use a less sensitive setting of two 2 or three 3 To set the OxiMax SPD Alert SPD sensitivity WARNING Supplemental oxygen will attenuate patterns of desaturation A patient s respiratory compromi...

Страница 63: ...limit the alarm sounds each time it violates an alarm limit Use the Pulse Rate Delay feature to distinguish clinically significant events from minor and brief pulse rate limit violations that result i...

Страница 64: ...e 6 on page 15 and Third SpO2 Event Triggers SatSeconds Alarm Figure 7 on page 16 Set upper and lower alarm limits using traditional alarm management methods Then use SatSeconds alarm management to de...

Страница 65: ...ced by pressing the ALARM SILENCE key When SatSeconds is set to OFF the SatSeconds icon does not appear on the screen SpO2 limit violations still cause TREND to flash until the caregiver presses the T...

Страница 66: ...ST UP or ADJUST DOWN keys below the ALARM SILENCE key on the oximeter panel to select the limit The choices are 10 25 50 100 SatSeconds or OFF A decimal to the lower right indicates it is not a defaul...

Страница 67: ...ta display Histogram trend data display The oximeter can graphically display trend data for SpO2 pulse rate or both Trend data is stored at one second intervals When the TREND softkey is pressed READI...

Страница 68: ...key scrolls the display to the right When the data displays the most recent readings are on the right side of the graph The numbers below SpO2 indicate the highest and lowest parameter values at the T...

Страница 69: ...nd data 1 With the oximeter in the normal monitoring mode press the TREND softkey 2 Press the MONITR softkey 3 Press the VIEW softkey 4 Press the DUAL softkey The dual trend SpO2 and Pulse Rate displa...

Страница 70: ...ng mode press the TREND softkey 2 Press the MONITR softkey 3 Press the VIEW softkey 4 Press the NEXT softkey 5 Press the AMP softkey The pulse amplitude units PAU trend data displays Figure 51 Pulse A...

Страница 71: ...Changing alarm limit settings uses up trend memory space Change alarm limits only as needed Note Trend memory always contains the most recent 45 hours of data with newly collected data overwriting th...

Страница 72: ...nts above and below the data point under the cursor The saturation graphical trend display vertical scale default setting is from 10 to 100 if there is no data under the cursor The pulse rate graphica...

Страница 73: ...x pulse oximetry sensor is connected to the oximeter a SENSOR TYPE message displays for four to six seconds at the bottom of the screen The message identifies the type model of OxiMax pulse oximetry s...

Страница 74: ...ition Message Screen Press the HELP key from the Condition message display for suggested corrective actions The following list identifies possible sensor adjust condition messages SENSOR OFF SMALL PUL...

Страница 75: ...Figure 58 Corrective Action Screen Enabling or Disabling the Sensor Message Feature The OxiMax pulse oximetry sensor message setup display allows you to enable or disable the sensor message feature W...

Страница 76: ...atient use sensors only The alarm event data is stored recorded with the limit threshold settings that were active at the time of the event on the recording oximeter These events can be viewed on the...

Страница 77: ...sor is connected both sensor types and the full set of options for each are displayed If a sensor is connected only the sensor data type for that sensor displays Figure 60 Identifying In Sensor Data T...

Страница 78: ...to indicate that the OxiMax pulse oximetry sensor attached to the oximeter contains patient event data The front panel blinks for approximately 60 seconds until the OxiMax pulse oximetry sensor is di...

Страница 79: ...entations of patient event history are only available on single patient use OxiMax pulse oximetry sensors Graphed data points are the minimum or maximum SpO2 value for each 30 second interval througho...

Страница 80: ...event display The user can move between events by using the two left most softkeys which are labeled with left and right facing arrow icons respectively At the beginning of an event sequence event one...

Страница 81: ...phical History Screen Screen 1of 5 Figure 67 Sensor Event Graphical History Screen Screen 4 of 5 Figure 68 Sensor Event Graphical History Screen Screen 5 of 5 To view and print in sensor Tabular Event...

Страница 82: ...previous page and displays the next three events Up or down arrow icons only appear if scrolling up or down is an option If an arrow icon is blank this indicates the beginning or end of the table 4 U...

Страница 83: ...ay be connected to a serial printer or PC by using a cable terminated with the following devices An AMP connector AMP part number 747538 1 A ferrule AMP part number 1 747579 2 Compatible pins AMP part...

Страница 84: ...lustrates the pin layouts as viewed from the rear panel The conductive shell connects to earth ground when connected to a PC or printer Figure 71 Data Port Pin Layout Table 9 Data Port Signal Pinouts...

Страница 85: ...tions for the OxiMax N 600x pulse oximeter differ from those of the oximeter with the SPD feature activated The factory default protocol is ASCII See Communication Protocol Compatibility and Output pa...

Страница 86: ...Trend Data Refer to the Service Manual or contact Nellcor s Technical Services Department at 1 800 635 5267 or your local Nellcor representative Real Time Output Real time data is continuously sent t...

Страница 87: ...ding changes The example above shows three distinct column heading sets Starting at the top row there are 25 lines before the second row of column headings print The third row of column headings in Fi...

Страница 88: ...nd the upper alarm limit is 100 Pulse Rate alarm limits are 40 and 170 BPM The SatSeconds alarm limit 100SAT S displays the SatSeconds alarm setting In this example SatSeconds is set to 100 Figure 77...

Страница 89: ...eter is available three dashes display PA represents the pulse amplitude value in which the number can range from 0 to 254 There are no alarm parameters for this value It can be used for trending info...

Страница 90: ...silenced The nurse call feature of the OxiMax N 600x pulse oximeter allows caregivers to remotely monitor patient alarms and works in conjunction with the nurse call system of your institution Access...

Страница 91: ...er setting up the OxiMax N 600x pulse oximeter in a location that uses nurse call If an attached OxiMax pulse oximetry sensor is not connected to a patient the oximeter display reads zeros and the oxi...

Страница 92: ...A voltage of 0 94 volts indicates a current SpO2 value of 94 To set analog voltage output 1 Press the SETUP softkey 2 Press the NEXT softkey three times 3 Press the ANALOG softkey Figure 85 Analog Vo...

Страница 93: ...within an institution to the same time The OxiMax N 600x pulse oximeter records a patient s sensor SpO2 event history from the sensor s memory chip allowing a patient s event history to travel with th...

Страница 94: ...application errors and certain patient conditions WARNING Do not immerse or wet the OxiMax pulse oximetry sensor Caution The sensor disconnect error message and associated alarm indicate that the sens...

Страница 95: ...es OxiMax Pulse Oximetry Sensor Model Patient Size Max Fast forehead sensor MAX FAST 10 kg OxiMax pulse oximetry sensor Sterile single use only MAX N MAX I MAX P MAX A MAX AL MAX R 3 or 40 kg 3 to 20...

Страница 96: ...nded biocompatibility testing and are therefore in compliance with ISO 10993 1 Optional Accessories Overview Several mounting configurations a carrying case and a utility basket are offered with the O...

Страница 97: ...lly available GCX brackets and securely mounts the oximeter to a wall bracket or a roll stand The adapter plate attaches to the bottom of the oximeter as shown For further instructions regarding conne...

Страница 98: ...mount arm and 19 inch channel from Nellcor The M Series wall mount arm attaches to the GCX adapter plate which attaches to the M Series arm The arm slides into the wall mount channel For further detai...

Страница 99: ...tand with utility basket and handle from Nellcor The GCX roll stand attaches to the oximeter GCX adapter plate as shown For further instructions regarding connecting the GCX roll stand refer to the il...

Страница 100: ...rrying Case Order the optional soft sided carrying case directly from Nellcor The padded carrying case protects the oximeter during transport The carrying case contains two pockets for OxiMax pulse ox...

Страница 101: ...imeter section of the N 600x Service Manual Have a qualified service technician perform these procedures prior to initial installation in a clinical setting Performance Considerations Primary Consider...

Страница 102: ...oxic Correcting anemia can improve arterial oxygen content The oximeter may fail to provide an SpO2 reading if hemoglobin levels fall below 5 gm dl OxiMax Pulse Oximetry Sensor Performance Considerati...

Страница 103: ...ed and observe all warnings and cautions presented in the directions for use accompanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to...

Страница 104: ...seconds earlier than digit sensors If the Max Fast pulse oximetry sensor is not available consider using the OxiMax Max R adhesive nasal sensor It obtains extremely accurate measurements from a nasal...

Страница 105: ...not spray pour or spill any liquid on the N 600x pulse oximeter its accessories connectors switches or openings in the chassis Help and Support Technical Services If you experience a problem while us...

Страница 106: ...rns of desaturation in the SpO2 trend in adults Caregivers are alerted to these patterns via a visual indicator and optionally an audio alarm The triangle icon for Saturation Pattern Detection appears...

Страница 107: ...he SpO2 value falls outside the limit and time the number of seconds the SpO2 the value remains outside the limit The SatSeconds limit sets the minimum value the SatSeconds must reach before an alarm...

Страница 108: ...Press BACK 6 Press ADJUST DOWN to highlight NEO and then press SHOW The HELP LIMITS NEO window appears Figure 94 Neonate Limits Help Screen 7 Press BACK 8 Press ADJUST DOWN to highlight ADULT and the...

Страница 109: ...sage In most instances messages remain displayed for a set time This depends on the criticality of the message High priority messages overwrite low priority messages Messages of the same priority disp...

Страница 110: ...CLOCK SETTING LOST None No No If the N 600x detects that the real time clock has stopped running and both battery and AC power are lost Power cycle the oximeter If the error remains recharge or replac...

Страница 111: ...ven though the ALARM SILENCE duration is OFF If attempting to save defaults turn ALARM SILENCE duration to a value rather than OFF INVALID SpO2 LIMIT 3 No Yes After attempting to set the default SpO2...

Страница 112: ...pting to save current settings as power on defaults by pressing SAVE in the PARAMS menu Confirm the new institutional default settings by selecting YES or leave default settings as they are by selecti...

Страница 113: ...place the battery 515 518 534 535 569 N 600x Boot Version x x x x The application software is missing or corrupt Notify a qualified service technician 529 729 LOW BATTERY The battery is discharged to...

Страница 114: ...powered off it cannot be powered on again until repaired To access primary speaker failure messages The oximeter may detect a failure of the primary speaker and sound a high pitched slow pulsing piez...

Страница 115: ...RY LED off LOW BATTERY message off Audible alarm off Error code none Effect of ALARM SILENCE key normal Shutdown N A 3 No Yes No SpO2 normal AC Battery charge LED off LOW BATTERY LED on LOW BATTERY me...

Страница 116: ...onditions State Critical Battery Low Battery AC Power Operation Table 19 Common Problems and Resolutions Problem Resolution There is no response when I press the ON STANDBY key Ensure the supply volta...

Страница 117: ...xiMax pulse oximetry sensor site and or try another type of OxiMax pulse oximetry sensor Interference may be preventing the oximeter from tracking the pulse Verify the OxiMax pulse oximetry sensor is...

Страница 118: ...appears in the oximeter display each time the oximeter successfully completes the power on self test Write the number down and have it available whenever requesting technical assistance Returning you...

Страница 119: ...wiping the surfaces of the oximeter Disinfection Use a soft cloth saturated with a solution of 10 chlorine bleach in tap water lightly wiping the surface of the oximeter Before attempting to clean an...

Страница 120: ...arts inside The OxiMax N 600x pulse oximeter requires no calibration Have a qualified service technician replace the battery at least every 24 months If service is necessary contact Nellcor s Technica...

Страница 121: ...emoglobin and deoxyhemoglobin differ in their absorption of red and infrared light measured using spectrophotometry and the volume of arterial blood in tissue and hence light absorption by that blood...

Страница 122: ...m This is a normal operation and does not require any user intervention Functional versus Fractional Saturation This pulse oximeter measures functional saturation where oxygenated hemoglobin is expres...

Страница 123: ...es clinically significant events from minor and brief SpO2 limit violations that result in nuisance alarms Set upper and lower alarm limits using traditional alarm management methods Then use SatSecon...

Страница 124: ...triangle icon Refer to Using the OxiMax SPD Alert Feature page 54 for detecting patterns of desaturation OxiMax Pulse Oximetry Sensor Technology Use OxiMax pulse oximetry sensors which are specifical...

Страница 125: ...ta required to properly evaluate the accuracy of a system s SpO2 measurements Fully evaluating the accuracy of the SpO2 measurements requires at a minimum accommodating the wavelength characteristics...

Страница 126: ...Theory of Operations 120 Operator s Manual Page Left Intentionally Blank...

Страница 127: ...ts AC nominal 230 VAC 30 VA Input Frequency 50 60 Hz Fuses Slow blow 0 5 amp 250 volts IEC 5 x 20 mm Quantity 2 external Battery Note The battery provides approximately seven hours of battery life whe...

Страница 128: ...spheric Pressure 70 kPa to 106 kPa 20 6 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Transport and Storage Not in shipping container In shipping container Temperature 20 C to 60 C 20...

Страница 129: ...meter performance Reading accuracy in the presence of low perfusion detected IR pulse modulation amplitude 0 03 1 5 was validated using signals supplied by a patient simulator SpO2 and pulse rate valu...

Страница 130: ...ed Light Wavelength Approximately 900 nm Optical Output Power Less than 15 mW Product Compliance Product Standards for Compliance ISO 9919 2005 EN ISO 9919 2005 Product Safety Standards IEC 60601 1 19...

Страница 131: ...his section Electromagnetic Compatibility EMC Electromagnetic Emissions Electromagnetic Immunity Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp...

Страница 132: ...age dips short interruptions and voltage variations on power supply IEC 61000 4 11 2004 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 0 5 cycle Mains power quality should be that of a typical...

Страница 133: ...NG The use of accessories OxiMax sensors and cables other than those specified may result in inaccurate readings of the OxiMax N 600x pulse oximeter and increased emission of the oximeter Table 23 Rec...

Страница 134: ...minated cable RS 232 analog 15 pin D 3 3 ft 1 m Printer cable RS 232 15 to 9 pin D 10 0 ft 3 m Philips interface cable 3 3 ft 1 m Oxinet III hardwire cable 10 0 ft 3 m Oxinet III data cable 10 0 ft 3...

Страница 135: ...eutral Line Cord IEC 60601 1 UL 60601 1 Normal Normal Closed Closed 500 A 300 A Single Fault Open Closed 1000 A Closed Open Normal Reversed Closed Closed 500 A 300 A Single Fault Open Closed 1000 A Cl...

Страница 136: ...Line Ground Cable IEC 60601 1 UL 60601 1 Normal Normal Closed Closed 100 A Single Fault Open Closed 500 A Closed Open Normal Reversed Closed Closed 100 A Single Fault Open Closed 500 A Closed Open Pa...

Страница 137: ...d on digits and brow to provide a balanced study design SpO2 values were continuously recorded from each instrument while inspired oxygen was controlled to produce five steady state plateaus at target...

Страница 138: ...opulation Table 27 Demographic Data Type Class Total Gender Male 5 Female 6 Race Caucasian 8 Hispanic 2 African American 1 Asian 0 Age 19 48 Weight 108 250 Skin pigment Very light 2 Olive 5 Dark olive...

Страница 139: ...ST Data Points Arms Data Points Arms Data Points Arms 60 70 71 3 05 71 2 89 71 2 22 70 80 55 2 35 55 2 32 55 1 28 80 90 48 1 84 48 1 73 48 1 48 90 100 117 1 23 117 1 68 117 0 98 1 Test Sensor Avg CO o...

Страница 140: ...deviations from the protocol Conclusion The pooled results indicate that for a saturation range of 60 80 for SpO2 the acceptance criterion was met for the monitoring system when tested with MAX A MAX...

Страница 141: ...alculated Saturation 116 Calibration 114 Carrying Case Soft Sided 94 Cautions 1 Cleaning 113 Clock 46 Clock Settings Lost 104 107 Confirmation Tone 11 Connecting an OXIMAX Sensor 24 Contrast 33 Contro...

Страница 142: ...softkey 8 Monitor Performance Considerations 95 Returning 112 Monitor Description 5 Monitor Displays Dashes 32 Monitor Trend Data 65 66 Monitoring Values 10 N Navigating Menu Options 41 Nurse Call RS...

Страница 143: ...Available 72 Sensor Event Record Not Available 73 Sensor Message Enable Disable 69 Sensor Message Setup 69 Sensor Off 84 Sensor Off SO 84 Sensor Power Dissipation 124 Sensor Type 106 Service Returning...

Страница 144: ...ions 109 Troubleshooting On Screen Help 99 Troubleshooting Oximeter Displays Dashes 32 83 85 Troubleshooting Primary Speaker Failure 107 Troubleshooting Prompts and Error Messages 103 Troubleshooting...

Страница 145: ......

Страница 146: ...ionally registered trademarks of Covidien AG Trademark of its respective owner Other brands are trademarks of a Covidien company 2014 Covidien Covidien llc 15 Hampshire Street Mansfield MA 02048 USA C...

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