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Rad-87 Pulse CO-Oximeter Operator’s Manual

2-7

s y s t e m d e s c r i p t i o n

SYMBOLS

The following symbols are found on the Rad-87 or packaging and are defined below:

RS-232

Equipotential Ground Terminal

Consult accompanying documents

Nurse Call Interface

WEEE compliant

Mark of Conformity to European Medical Device Directive
93/42/EEC

Rx Only

Federal law restricts this device to sale by or on the order
of a physician (USA audiences only)

Year of manufacture

5%-95% RH

Storage humidity range: 5% to 95%

-40 C

+70 C

+1060 hPa - +500 hPa

795 mmHg - 375 mmHg

Storage temperature range: +70˚C to -40˚C
Storage altitude range: +1600hPa to +500hPa

Keep dry

Fragile/breakable, handle with care

Indicates wireless Radio signal (wireless radio model only)

EC REP

EU authorized representative

Defi brillation Proof Type BF

Caution

FCC ID: VKF-RAD87

Federal Communications Commission (FCC) licensing
(wireless radio model only)

IC ID: 7362A-RAD87

Industry Canada licensing (wireless radio model only)

Содержание Rad-87

Страница 1: ...Oxyhemoglobin Carboxyhemoglobin Methemoglobin Pulse Rate parameters and Perfusion Index Pleth Variability Index measurements OPERATOR S MANUAL Rad 87 Pulse CO Oximeter...

Страница 2: ...OPERATOR S MANUAL Rad 87 Pulse CO Oximeter...

Страница 3: ...FORMS TO UL STD 60601 1 UL STD 763 UL STD 963 AND NSF STD 12 CERTIFIED TO CAN CSA STD C22 2 NO 601 1 3149433 Covered by one or more of the following U S Patents RE38 492 RE38 476 7 221 971 7 215 986 7...

Страница 4: ...cing to Masimo for repair of this equipment As with all medical equipment carefully route patient cabling to reduce the possibil ity of patient entanglement or strangulation Do not place the Rad 87 or...

Страница 5: ...y affect the Pulse CO Oximeter preventing it from working properly Do not expose the Rad 87 to excessive moisture such as direct exposure to rain Excessive moisture can cause the device to perform ina...

Страница 6: ...nce with FCC requirements the Rad 87 device with optional radio must be placed greater then 20 cm from the patient s head In accordance with FCC requirements radio accessories on the Rad 87 device wit...

Страница 7: ...asimo Rainbow SET Parallel Engines 1 8 Masimo SET DST 1 8 SECTION 2 SYSTEM DESCRIPTION Introduction 2 1 Rad 87 Front Panel Controls 2 2 Rad 87 Rear Panel 2 6 Symbols 2 7 LCD Display 2 8 SECTION 3 SETU...

Страница 8: ...7 Setup Menu Level 2 4 18 Alarm Volume 4 18 Alarm Silence 4 18 Alarm Delay 4 19 Clear Trend 4 20 Button Volume 4 20 FastSat 4 21 Trend Setup and Use 4 21 Introduction 4 21 Trend Utility Installation 4...

Страница 9: ...cation 5 1 Alarm Indication 5 2 Alarm Limits 5 2 Single Alarm Features 5 4 Multi Parameter Measurement Alarms 5 4 Alarm Priority for Display Screens 5 5 Alarm Silence 5 5 Alarm Bell 5 5 System Status...

Страница 10: ...cialty Sensors 8 4 LNCS Reusable Sensors 8 5 LNCS Adhesive Sensors 8 5 LNCS Specialty Sensors 8 5 Sensor Accuracy 8 6 Cleaning And Reuse Of Masimo Reusable Sensors and Cables 8 6 Reattachment of Singl...

Страница 11: ...escribestheRad 87PulseCO Oximeter system and its functions and features SECTION 3 SETUP describes how to setup the Rad 87 Pulse CO Oximeter for use SECTION 4 OPERATION describes the operation of the R...

Страница 12: ...ous adverse affect death to the patient or user Look for text in a gray shaded box Sample of Warning WARNING THIS IS A SAMPLE OF A WARNING STATEMENT A CAUTION is given when any special care is to be e...

Страница 13: ...en used with an LNOP Blue Sensor Signal IQ provides signal identification and quality indication during excessive motion and low signal to noise situations FastSat tracks rapid changes in arterial O2...

Страница 14: ...O GENERAL DESCRIPTION Pulse CO Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin SpCO in arterial blood It relies on the same basic principles of pulse oxime...

Страница 15: ...the amount of light absorbed by the varying quantities of arterial blood changes as well The Rad 87 Pulse CO Oximeter uses a multi wavelength sensor to distinguish between oxygenated blood deoxygenate...

Страница 16: ...tial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin In the case of SpCO different results are also expected if concentration of methemoglobin in the blood gas sample is abnormal greater...

Страница 17: ...ve confidence in the value of a parameter due to poor signal quality caused by excessive motion or other signal interference the measurement for the parameter will alternate with FASTSAT FastSat enabl...

Страница 18: ...1 8 Rad 87 Pulse CO Oximeter Operator s Manual MASIMO RAINBOW SET PARALLEL ENGINES MASIMO SET DST This figure is for conceptual purposes only 1 12 FST MST o v e r v i e w...

Страница 19: ...ft side of the front panel for the Rad 87 horizontal device and the bottom of the front panel for the Rad 87 vertical device Rad 87 offers full Masimo SET technology in a small compact device Rad 87 s...

Страница 20: ...CD Display 1234567890123456 0123456789123456 The LCD display identifies system settings monitoring modes alarm limits and information from Patient SafetyNet or PhilipsVueLink when connected 4 Signal I...

Страница 21: ...ers and measurements Also used to exit setup menu screens and return the display to Screen 1 Press and hold the button down for 5 seconds to scroll through device settings on the LCD Display 9 Alarm B...

Страница 22: ...th Variability Index PVI is displayed as a percentage The lower the height of the bar the less variability there is in the PI over a respiratory cycle Press the Display key to toggle to the PVI numeri...

Страница 23: ...ter Operator s Manual 2 5 s y s t e m d e s c r i p t i o n 2 RAD 87 PULSE CO OXIMETER VERTICAL 888 888 888 888 888 888 888 888 888 888 888 888 8 19 17 13 10 5 9 12 6 20 1 14 7 2 4 15 11 18 16 MAX MAX...

Страница 24: ...87 to the main power for continuous operation and or battery recharging 4 EQUIPOTENTIAL GROUND CONNECTOR Use the Equipotential Ground Connector for grounding 1 2 3 4 32294 4778A 1207 100 240v 50 60 H...

Страница 25: ...e to sale by or on the order of a physician USA audiences only Year of manufacture 5 95 RH Storage humidity range 5 to 95 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg Storage temperature range 70 C to...

Страница 26: ...ollowing Patient SafetyNet The LCD Display shows the information sent from the Patient SafetyNet to the Rad 87 Philips VueLink The LCD Display shows VueLink Conn and SpO2 PR AL On or SpO2 PR AL Off NO...

Страница 27: ...ENTS Always use a hospital grade AC power cable to connect the Rad 87 to an AC power source CAUTION DO NOT CONNECT THE RAD 87 TO AN AC OUTLET CONTROLLED BY A SWITCH Verify the AC power voltage and fre...

Страница 28: ...e device Make sure that Rad 87 loudspeaker is not covered to avoid a muffled alarm sound The Rad 87 should not be operated outside the following environmental conditions OPERATING ENVIRONMENTAL CONDIT...

Страница 29: ...e any substances that may interfere with the transmission of light between the sensor s light source and detec tor 4 Refer to the Directions for Use of the sensor before attaching the sensor to the pa...

Страница 30: ...een 1 Parameter Measurement Alarm Limits Screen 2 Parameter Measurement Alarm Limits Screen 3 in this chapter An alarm tone sounds The Alarm Bell flashes red for high priority alarms The System Status...

Страница 31: ...alarm limits Adjust the alarm volume Adjust the pulse beep volume 15 Verify the sensor is applied correctly and that the measured data is appropriate see Section 4 Successful Monitoring 16 Monitor the...

Страница 32: ...vels 1 thru 4 Pulse tone volume Level 2 Off Levels 1 thru 3 Alarm Silence Time 120 seconds 30 60 90 or 120 seconds Alarm Volume Level 3 70 db min Levels 1 thru 4 87 db max Monitoring Mode Standard Nor...

Страница 33: ...ILIZE BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE UNLESS OTHERWISE INDICATED IN THE SENSOR DIRECTIONS FOR USE SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR ALL MASIMO REUSABLE SENSO...

Страница 34: ...ne green or methylene blue Abnormal hemoglobin levels Low arterial perfusion Low arterial oxygen saturation levels Elevated Total Bilirubin levels Motion artifact NUMERIC DISPLAY SpMet A stable SpMet...

Страница 35: ...ENT AND IF INDICATED VERIFY OXYGENATION STATUS THROUGH OTHER MEANS 3 Severinghaus JW Spellman MJ Pulse Oximeter FailureThresholds in Hypotension andVasoconstriction Anesthesiology 1990 73 532 537 SIGN...

Страница 36: ...not possible operate the Rad 87 on battery power or try plugging the device into a different electrical outlet If artificial nails or excessive fingernail polish are present select another site or rem...

Страница 37: ...a low battery condition occurs the audible alarm can be silenced for 120 seconds default by pressing the Alarm Silence Button Refer to Setup Menu Level 2 in this section to change setting If a low bat...

Страница 38: ...e display to show Screen 3 containing methemoglobin SpMet and carboxyhemoglobin SpCO An additional press of the Display Button returns the display to Screen 1 the home display screen Optional paramete...

Страница 39: ...reens With PVI Installed and SpMet and SpCO Not Installed Display Screens When SpMet SpCO and PVI are Not Installed 4 11 4 o p e r a t i o n Screen 1 Home display screen Screen 2 Screen 3 6 3 Screen 1...

Страница 40: ...I on multiple screens the alarm limit menu for PVI must be accessed from the default location NOTE When one parameter measurement is configured for all three screens the other parameter measurement wi...

Страница 41: ...ee levels of menus are available to the user Once a menu level is accessed a front panel button Level 1 only or the Enter Button Level 2 and 3 is used to move from one option to the next allowing repe...

Страница 42: ...rm Limits Button to access the Alarm Limits menu for Screen 1 parameters measurements BUTTONS SETTINGS Use the Alarm Limits Button to access the alarm limits options and move between options Press onc...

Страница 43: ...ameters measurements BUTTONS SETTINGS Use the Alarm Limits Button to access the alarm limits options and move between options Press once PI LO Use Up or Down Buttons to adjust the value to the desired...

Страница 44: ...nd move to the next option Once the last option is accessed an additional press of the Alarm Limits Button will return the device to Screen 3 OR press the Display Button to exit at any time and return...

Страница 45: ...TTING Use the Sensitivity Button to access the sensitivity options and move between options Press once Default APOD Use the Sensitivity Button to move between menu options and the Enter Button to acce...

Страница 46: ...r Down Button to move between settings and the Enter Button to accept the setting and move to the next menu screen OR press the Display Button to exit without saving the new setting and to return to t...

Страница 47: ...hout saving the new setting and to return to the home display screen 0 seconds 15 seconds 10 seconds CLEAR TREND The Rad 87 only stores data in the trend memory while the device is turned on Trend dat...

Страница 48: ...tion changes Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend When the Rad 87 is set to FastSat On the averaging algorithm evaluates all the sa...

Страница 49: ...down menu 6 Select the appropriate com port number from the second pull down menu if necessary 7 Select the Output Delimiter Option Tab Comma or Space 8 Select the RETRIEVETREND button on the TrendCo...

Страница 50: ...mal operation no exceptions 001 No Sensor 002 Defective Sensor 004 Low Perfusion 008 Pulse Search 010 Interference 020 Sensor Off 040 Ambient Light 080 Unrecognized Sensor 100 reserved 200 reserved 40...

Страница 51: ...he menu options by continuing to press the Enter Button Pressing the Display Button will exit the menu and return the display to home display screen AVERAGING TIME BUTTONS SETTINGS Hold down the Enter...

Страница 52: ...Enter Button again to move to the next menu 2x Default On Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu OR press the Display...

Страница 53: ...s the Enter Button to accept the setting and move to the next menu OR press the Display Button to exit without saving the new setting and to return to the home display screen User Default Set to user...

Страница 54: ...change from the Device Profile settings To save the settings as a profile from the Rad 87 button menu the user must enter Setup Menu Level 3 by pressing and holding the Enter Button and Down Button at...

Страница 55: ...ing excessive motion and low perfusion conditions The pulse tone is based on an averaged pulse rate measurement from the proprietary algorithm and may not identify irregular heart beat patterns when t...

Страница 56: ...ress the Display Button to exit without saving the new setting and to return to the home display screen Use Up or Down Button to adjust the setting MONTH BUTTONS SETTING Press the Enter Button again t...

Страница 57: ...ress the Display Button to exit without saving the new setting and to return to the home display screen Use Up or Down Button to adjust the setting HOUR BUTTONS SETTING Press the Enter Button again to...

Страница 58: ...00 Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu OR press the Display Button to exit without saving the new setting and to r...

Страница 59: ...re muted at the Rad 87 and active at the interfaced system This prevents both systems from producing SpO2 and BPM audible alarms at the same time NOTE The Rad 87 reverts to Interface Alarms On during...

Страница 60: ...6 The Rad 87 Pulse CO Oximeter can be set up to audibly indicate all patient alarms while communicating with the Philips VueLink module Use the Interface Alarms setting in the Output menu to enable an...

Страница 61: ...the new setting and to return to the home display screen Signal IQ Alarm and Signal IQ Refer to Section 7 Nurse call specifications for additional information POLARITY BUTTONS SETTING Press the Enter...

Страница 62: ...TTING Press the Enter Button again to move to the next menu option 16x Default 60 Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next m...

Страница 63: ...enu option OR press the Display Button to exit without saving the new setting and to return to the home display screen no parameter measurement displayed PARAMETER SELECT SCREEN 2 NOTE When one parame...

Страница 64: ...le Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu option OR press the Display Button to exit without saving the new setting a...

Страница 65: ...TING Hold down the Enter Button and press the Up Button for 5 seconds Default Standard Use Up or Down Button to move between settings AND press the Enter Button to accept the setting OR press the Disp...

Страница 66: ...ressed and held for 3 seconds The Enter and Up Buttons held simultaneously for 5 second will put it back into the special menu to select a different mode SLEEP MODE OPERATION The Rad 87 can be placed...

Страница 67: ...TING Hold down the Brightness Button and press the Down Button for 5 seconds Default Off Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and exit to the...

Страница 68: ......

Страница 69: ...priority The following table outlines the alarm priority specifications PARAMETER MEASUREMENT ALARM SETTING RANGE High Low saturation Audible and visual High carboxyhemoglobin saturation High methemog...

Страница 70: ...splay NOTE An audible alarm will accompany the visual indicators unless the Rad 87 has been set to Interface Alarms Off only SpO2 and BPM alarms muted or to Sleep Mode all alarms muted ALARM LIMIT USE...

Страница 71: ...VI High Limit alarm is disabled PVI Low Limit The PVI low alarm limit can be set anywhere between Off then 1 and 98 Adjust in increments of 1 step size When PVI is placed in the Off setting the PVI Lo...

Страница 72: ...ht is solid yellow for low priority alarms flashing yellow for medium priority alarms and flashing red for high priority alarms Additional parameters measurements in alarm status compet ing alarms tha...

Страница 73: ...larm Silence Button will cycle though alarm silence options above Alarm Silence function when not monitoring a patient Power On Alarms active Alarm Bell is not flashing and the System Status Light is...

Страница 74: ...While not monitoring a patient the System Status Light illuminates solid yellow If an alarm condition occurs the System Status Light shows solid yellow for low priority alarms Pressing the Alarm Silen...

Страница 75: ...e out occlusion of blood flow 2 Attempt to warm patient 3 Move sensor to better perfused site NOTE Masimo recommends using an adhesive sensor whenever low perfusion is expected or evident PARAMETER ME...

Страница 76: ...No Sensor Connected Connect sensor to cable Sensor off patient 1 Reattach sensor to patient 2 Verify proper sensor placement SINGLE BATTERY LEVEL INDICATOR FLASHES WITH AUDIBLE ALARM Battery level to...

Страница 77: ...rn the device off press and hold the Power Button for 5 seconds Return the device for service NO SPEAKER TONE Pulse tone set to mute Press Up Arrow or Alarm Volume Adjust NO ALARM TONE Alarm Silence E...

Страница 78: ...nt site Replace sensor or cable SpO2 VALUES DO NOT CORRELATE WITH CLINICAL ASSESSMENT OR ABGs Low perfusion or sensor displacement Check for error messages See section 5 Messages for recommended cor r...

Страница 79: ...size Verify proper sensor and sensor size for the patient Excessive ambient or strob ing light Shield the sensor from excessive or strobing light Also see Section 4 Successful Monitoring for addition...

Страница 80: ......

Страница 81: ...onates 2 Pulse Rate Accuracy5 Pulse Rate 25 240 bpm No Motion Adults Infants Pediatrics Neonates 3 bpm Motion4 Adults Infants Pediatrics Neonates 5 bpm Low Perfusion Adults Infants Pediatrics Neonates...

Страница 82: ...ndition system failure and low battery alarms High Priority Audible Alarm 800 Hz tone 5 pulse burst pulse spacing 0 250s 0 250s 0 500s 0 250s repeat time 10s Medium Priority Audible Alarm 500 Hz tone...

Страница 83: ...in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced...

Страница 84: ...ch data packet contains the date time SpO2 perfusion index SpMet SpCO PI pulse rate and alarm and exception values in ASCII 2 format SERIAL INTERFACE SETUP To interface with the Rad 87 serial port set...

Страница 85: ...ions The nurse call features are accessible via the 1 4 round female connector on the back of the device NURSE CALL The nurse call feature on the Rad 87 Pulse CO Oximeter is based on the relay closing...

Страница 86: ...7 6 Rad 87 Pulse CO Oximeter Operator s Manual...

Страница 87: ...BILITY OF THE MONITOR CABLE AND SENSOR BEFORE USE OTHERWISE PATIENT INJURY CAN RESULT SELECTING A MASIMO SET SENSOR When selecting a sensor consider the patient s weight the adequacy of perfusion the...

Страница 88: ...w RC cables DC 3 DC 12 DCI Middle or ring finger 30 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 3 1 DCP 3 DCP 12 DCIP Middle or ring finger or thumb 10 50 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 3 1 R...

Страница 89: ...nction with Red PC cables SENSOR Weight Range Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy No Motion Motion No Motion Motion Saturation Pulse Rate DC 3 DC 12 30 kg 2 3 3 bpm 5 bpm 2...

Страница 90: ...t L 1 kg 3 3 3 bpm 5 bpm 3 3 bpm LNOP Inf L 3 20 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOPv TM ADHESIVE SENSORS LNOPv adhesive sensors must be used in conjunction with Red PC cables SENSOR Weight Range Saturati...

Страница 91: ...e Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy No Motion Motion No Motion Motion Saturation Pulse Rate LNCS Adtx LNCS Adtx 3 30 kg 2 3 3 bpm 5 bpm 2 3 bpm LNCS Pdtx LNCS Pdtx 3 10 50...

Страница 92: ...LLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF PATIENT ENTANGLEMENT OR STRANGULATION REATTACHMENT OF SINGLE USE ADHESIVE SENSORS Single use sensors may be reapplied to the same patient if the e...

Страница 93: ...cleaned with a soft cloth dampened with a mild detergent and warm water solution Do not allow liquids to enter the interior of the instrument The outer surface of the instrument can also be wiped dow...

Страница 94: ...about 2 seconds all available LEDs are illuminated and a brief beep tone sounds 2 The Rad 87 begins normal operation KEY PRESS BUTTONTEST 1 With the exception of the Power press each button and verify...

Страница 95: ...90 see Section 4 Setup Menu Level 1 Parameter Measurement Alarm Limits Screen 1 and Setup Menu Level 2 Alarm Volume 7 Verify that an audible alarm activates the SpO2 measurement and the SpO2 paramete...

Страница 96: ...Ask for an RMA number Package the equipment securely in the original ship ping container if possible and enclose or include the following information and items A letter describing in detail any diffi...

Страница 97: ...rranty Purchaser must contact Masimo for a returned goods authorization If Masimo determines that a Product must be replaced under warranty it will be replaced and the cost of shipment covered All oth...

Страница 98: ...duct for its labeled purpose as set forth in these directions for use Masimo reserves all rights not expressly granted to Purchaser 2 Ownership of Software The Software is licensed not sold all rights...

Страница 99: ...duties or obligations arising hereunder other than as set forth in this para graph shall be void 4 U S Government Rights If Purchaser is acquiring Software including the related documentation on behal...

Страница 100: ...r s Manual French 32771 Rad 87 Operator s Manual German 32772 Rad 87 Operator s Manual Italian 32773 Rad 87 Operator s Manual Spanish 32774 Rad 87 Operator s Manual Japanese 32775 Rad 87 Operator s Ma...

Страница 101: ...action Technology SET Radical Signal IQ SIQ FastSat LNOP and LNCS are federally registered trademarks of Masimo Corporation Rainbow and SpCO are federally registered trademarks of Masimo Laboratories...

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