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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

O p e r a t i o n

Setup Menu Level 1 – Alarm Volume and Alarm Silence
Push the Enter button to enter menu level 1.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87

FCC ID: VKF-RAD87

Alarm Volume

Use

Down

Arrow Keys to adjust

parameter to desired setting.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

Title

Program

Date

Diana Yuan

GR-11085

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Date

Alarm on/off

Setup Menu Level 2 – Alarm Limits
Push the Enter button again to enter menu level 2. If the Instrument has not been upgraded, only the

basic parameters will display.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87

FCC ID: VKF-RAD87

SpCO* Low Alarm Limit

Use

Down

Arrow Keys

to adjust parameter to desired

setting.

*available in upgraded

Instrument

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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Date

Diana Yuan

GR-11085

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Marketing Communications

Date

SpCO* High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

Approvals

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Number

Title

Program

Date

Diana Yuan

GR-11085

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Illustration, Rainbow, Buttons, 4/05

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4/1/05

Marketing Communications

Date

SpMet* Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

Approvals

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Number

Title

Program

Date

Diana Yuan

GR-11085

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4/1/05

Marketing Communications

Date

SpMet* High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

Title

Program

Date

Diana Yuan

GR-11085

Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications

Date

SpO

Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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DRO 5201

Approvals

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Program

Date

Diana Yuan

GR-11085

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4/1/05

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SpO

High Alarm Limit

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DRO-11386

CONFIDENTIAL AND PROPRIETARY

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Program

Date

Diana Yuan

GR-11085

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4/1/05

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Date

PR Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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DRO 5201

Approvals

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Number

Title

Program

Date

Diana Yuan

GR-11085

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PR High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

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Number

Title

Program

Date

Diana Yuan

GR-11085

Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

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4/1/05

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Date

PVI* Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

Title

Program

Date

Diana Yuan

GR-11085

Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications

Date

PVI* High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

Title

Program

Date

Diana Yuan

GR-11085

Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications

Date

PI Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

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FRM 1379 Rev A

DRO 5201

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Number

Title

Program

Date

Diana Yuan

GR-11085

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PI High Alarm Limit

Summary of Contents for Rad-57

Page 1: ...OPERATOR S MANUAL Signal Extraction Pulse CO Oximeter Masimo Rainbow SET ...

Page 2: ......

Page 3: ...simo Corporation 40 Parker Irvine CA 92618 USA Tel 949 297 7000 Fax 949 297 7001 www masimo com EU Authorized Representative for Masimo Corporation MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany Covered by one or more of the following U S patents 5482036 5490505 5632272 5685299 5758644 5769785 5919134 6002952 6011986 6067462 6157850 6229856 6236872 6263222 6360114 6388240 6430525 6463311 65019...

Page 4: ...e rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias The Rad 57 should not be used as a replacement or substitute for ECG based arrhythmia analysis As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation Do not place the Rad 57 or accessories in any p...

Page 5: ...rate SpO2 readings can be caused by z Improper sensor placement z Elevated levels of COHb and MetHb z For increased COHb COHb levels above normal tend to increase the level of SpO2 The level of increase is approximately equal to the amount of COHb that is present z NOTE High levels of COHb may occur with a seemingly normal SpO2 When elevated levels of COHb are suspected laboratory analysis CO Oxim...

Page 6: ...rence that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accord...

Page 7: ...ed accessories are cleared by the Food and Drug Administration FDA for noninvasive patient monitoring and may not be used for any processes procedures experiments or any other use for which the device is not intended or cleared by the FDA or in any manner inconsistent with the instructions for use or labeling The device and related accessories are not intended for use in combination with other med...

Page 8: ...Measurements 1 9 Masimo SET Signal Extraction Technology For SpO2 Measurements 1 9 SpMet and SpCO Measurements During Patient Motion 1 9 Masimo Rainbow SET Parallel Engines 1 10 Masimo SET DST 1 10 SECTION 2 SYSTEM DESCRIPTION Introduction 2 1 Rad 57 Front Panel Controls 2 2 Rad 57 Rear Panel 2 4 Battery Installation 2 4 Symbols 2 5 SECTION 3 SETUP Introduction 3 1 Unpacking and Inspection 3 1 Pre...

Page 9: ... Settings 4 14 Setup Menu Level 5 LED Brightness and Factory Defaults 4 15 Menu Selection 4 15 Power Off 4 15 Special Menu 4 16 Special Menu Line Frequency Configuration 4 16 Trend Setup and Use 4 17 Introduction 4 17 TrendCom Utility Installation 4 17 Erasing Trend Memory 4 17 Trend Data Format 4 17 SECTION 5 ALARMS AND MESSAGES Alarm Indication 5 1 Alarm Limits 5 1 Alarm Silence 5 3 Alarm Silenc...

Page 10: ...Specialty Sensors 8 6 LNOPv TM Adhesive Sensors 8 6 Sensor Accuracy 8 6 Cleaning And Reuse Of Masimo Reusable Sensors and Cables 8 6 Reattachment of Single Use Adhesive Sensors 8 6 SECTION 9 SERVICE AND MAINTENANCE Introduction 9 1 Cleaning 9 1 Battery Replacement 9 2 Performance Verification 9 2 Power On Self Test 9 2 Key Press Button Test 9 2 Alarm Limit Test 9 3 LED Brightness 9 3 Service and R...

Page 11: ...includes the following sections SECTION 1 Overview gives a general description of Pulse CO Oximetry SECTION 2 System Description describes the Rad 57 system functions and features SECTION 3 Setup describes how to setup the Rad 57 for use SECTION 4 Operation describes the operation of the Rad 57 SECTION 5 Alarms and Messages describes the alarm system messages SECTION 6 Troubleshooting gives troubl...

Page 12: ...s outcome i e injury serious 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 exercised by the patient or user to avoid injury to the patient damage to this instrument or damage to other property Sample of Caution CAUTION THIS IS A SAMPLE OF A CAUTION ST...

Page 13: ...s described in the Field Upgrader Tool Directions for Use part number 31650 The following list outlines the key features and benefits of the Rad 57 Handheld Pulse CO Oximeter Features and Benefits Clinically proven Masimo SET technology performance Proven for accurate SpO2 and pulse rate monitoring in motion and low perfusion environments SpO2 pulse rate Perfusion Index Pleth Variability Index PVI...

Page 14: ...obin SpO2 and pulse rate measured by an SpO2 sensor and carboxyhemoglobin and methemoglobin saturation or methemoglobin measured by an SpCO SpMet sensor The Masimo SET Rad 57 Pulse CO Oximeter and accessories are indicated for use with adult pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals hospital type facili...

Page 15: ...lacing a sensor on a patient usually on the fingertip for adults and the hand or foot for neonates The sensor connects to the pulse oximetry instrument with a patient cable The sensor collects signal data from the patient and sends it to the instrument The instrument displays the calculated data in two ways 1 As a percent value for arterial oxygen saturation SpO2 2 As a pulse rate PR The following...

Page 16: ...nt usually on the fingertip for adults and the hand or foot for infants The sensor connects either directly to the Pulse CO Oximetry instrument or through an instrument patient cable The sensor collects signal data from the patient and sends it to the instrument The Rad 57 displays the calculated data as percentage value for the SpMet Pleth Variability Index PVI General Description The Pleth Varia...

Page 17: ... patient s current oxygenation status With FastSat the averaging time is dependent on the input signal SmartTone The SmartTone feature uses a proprietary algorithm that will provide pulse tones during 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 ther...

Page 18: ...ble and infrared lights LED s 500 to 1000nm through a capillary bed for example a fingertip a hand a foot and measuring changes in light absorption during the blood pulsatile cycle This information may be useful to clinicians The maximum radiant power of the strongest light is rated at 25mW The detector receives the light converts it into an electronic signal and sends it to the Rad 57 for calcula...

Page 19: ...as sample is taken Subsequently blood gas and laboratory CO Oximetry measurements of SpO2 SpCO and SpMet may vary with the rapid administration of fluids and in procedures such as dialysis Additionally drawn whole blood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing Masimo SET Signal Extraction Technology For SpO2 Measurements Masimo Signa...

Page 20: ...1 10 Rad 57 Signal Extraction Pulse CO Oximeter Operator s Manual 1 O v e r v i e w Masimo Rainbow SET Parallel Engines This figure is for conceptual purposes only Masimo SET DST 12 FST MST ...

Page 21: ...t The Rad 57 is powered by 4AAalkaline batteries which provides a minimum of 8 hours of battery life Rad 57 offers full Masimo Rainbow SET Technology in a small hand held instrument Rad 57 supports the full line of Masimo sensors see Section 8 Sensors and Patient Cables Provides 72 hours of trending memory A Direct Connect Rainbow reusable sensor or patient cable or a Direct Connect Red reusable s...

Page 22: ... of the bar indicates the quality of the signal 3 Display Button Press to display the parameters measurements selected in the Setup Menu screens Refer to Chapter 4 Setup Menu Level 5 for the options 4 Enter Button Used to enter the setup menus and to select activate certain entries within the menu setup system 5 Next Button Used within the menu setup system to move through setup options Not active...

Page 23: ...rcentage of pulsatile signal to non pulsatile signal The bar is highest when the quality of the perfused site is best 12 Parameter Measurement Value Display and Indicator Displays parameter measurement numeric values and indicates parameter measurement label 13 Low SIQ Flashes to indicate low Signal IQ Refer to Section 4 Low Signal IQ for details 14 Alarm Silenced Indicator The indicator can flash...

Page 24: ... Instrument GRAPHIC DOCUMENTATION AND APPROVAL GR 10887 DRO 8890 CONFIDENTIAL AND PROPRIETARY 2001 Masimo Corporation All Rights Reserved Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals Approvals Document Number Title Program Date Michelle Diaz GR 10887 Adobe Illustrator 10 0 eps Illustration callouts for tables 2 04 2 4 04 Marketing Communications Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1...

Page 25: ...ructions for Use 4 Type BF applied part complying with IEC 60601 1 Symbol eference only do not print WEEE Compliant Mark of Conformity to European Medical Device Directive 93 42 EEC Rx ONLY Federal law USA restricts this device to sale by or on the order of a physician Underwriter s Laboratories Inc approved Storage humidity range Storage temperature range Storage altitude range Keep dry Fragile b...

Page 26: ...2 6 Rad 57 Signal Extraction Pulse CO Oximeter Operator s Manual 2 S y s t e m D e s c r i p t i o n ...

Page 27: ...rton and examine for signs of shipping damage Check all materials against the packing list Save all packing materials invoice and bill of lading These may be required to process a claim with the carrier If anything is missing or damaged contact the Technical Service Department The contact address and phone numbers are listed in Section 9 Service and Maintenance P r e p a r a t i o n f o r M o n i ...

Page 28: ... sounds a brief tone 4 Configure the Instrument for your regional power line frequency 50 or 60 Hz if needed Default is 60 Hz standard for the United States See Section 4 Special Menu Special menu Line Frequency Configuration CAUTION THE INSTRUMENT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORES CENT LIGHTS AND OTHER SOURCES ...

Page 29: ... Sensors and Patient Cables If using a single patient adhesive or disposable sensor check that the emitter red light and the detector are properly aligned Remove any substances that may interfere with the transmission of light between the sensor s light source and detector 5 Follow the Indications Instructions and Cautions in the sensor s Direction for Use when attaching reattaching or disconnecti...

Page 30: ...Visual Alarm Indicator flashes Disconnect the sensor from the patient cable or oximeter Confirm that NO SEn message appears on the display NOTE NO SEn and SEn OFF will only generate an alarm if the Rad 57 was actively monitor ing a patient when the sensor was disconnected 13 Verify parameter measurement violation alarm silence operation Create an alarm condition by lowering the SpO2 or pulse rate ...

Page 31: ...t is OFF Pulse rate low alarm limit Default is 50 BPM Set to Pre Power Down Setting See Section 5 Alarm Limits for all settings Pulse rate high alarm limit Default is 140 BPM PVI low alarm limit Default is Off Set to Pre Power Down Setting See Section 5 Alarm Limits for all settings PVI high alarm limit Default is Off PI low alarm limit Default is Off Set to Pre Power Down Setting See Section 5 Al...

Page 32: ... AT POWER UP Alarm Volume Default is level 1 Set to Pre Power Down Setting Levels 1 through 4 Line Frequency Default is 60 Hz Set to Pre Power Down Setting 50 Hz 60 Hz Trend Active Default is Off Set to Pre Power Down Setting Off On Alarm Silence Default is All Alarms Active Set to All Alarms Active Alarm on off available in upgraded Instrument ...

Page 33: ...TEAM AUTOCLAVE OR ETHYLENE OXIDE UNLESS OTHERWISE INDICATED ON THE SENSOR S DIRECTIONS FOR USE SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE DO NOT USE DAMAGED PATIENT CABLES DO NOT IMMERSE THE PATIENT CABLES IN WATER SOLVENTS OR CLEANING SOLUTIONS THE PATIENT CABLE CONNECTORS ARE NOT WATERPROOF DO NOT STERILIZE BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE DO NOT ATTEMPT TO REPROCESS...

Page 34: ...es in averaging times There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation Significant differences may indicate a problem with the Signal IQ due to physiological changes in the patient or one of the devices or application of the sensor or patient cable The pulsations from intra aortic balloon support can be additive to the pulse rate displayed on th...

Page 35: ...eadings are greater than 2 Elevated levels of bilirubin Motion artifact Low arterial oxygen saturation levels including altitude induced hypoxemia Numeric Display SpMet upgraded Instrument A stable SpMet reading is associated with correct sensor placement small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site Physiological changes at ...

Page 36: ...e Low SIQ indicator is flashing proceed with caution and do the following Assess the patient Check the sensor and ensure proper sensor application The sensor must be well secured to the site for the Rad 57 to maintain accurate readings Also misalignment of the sensor s emitter and detector can result in smaller signals Determine if an extreme change in the patient s physiology and blood flow at th...

Page 37: ...ecommended mode for typical monitoring purposes It is advisable for care areas where patients are observed frequently such as ICU s Adaptive Probe Off Detection APOD This is the recommended monitoring mode where there is a high probability of the sensor becoming detached It is also the suggested mode for care areas where patients are not visually monitored continuously This mode delivers enhanced ...

Page 38: ...Button will suspend the the alarm until the power is cycled or patient monitoring begins If a low battery condition occurs immediately discontinue patient monitoring and replace the batteries NOTE Remove batteries when storing Instrument for prolonged periods to maintain battery life WARNING FAILURE TO REPLACE BATTERIES PROMPTLY AFTER A LOW BATTERY ALARM MAY RESULT IN THE CO OXIMETER SHUTTING DOWN...

Page 39: ... conditions Press a second time to return the Instrument to standard alarm monitoring APHIC DOCUMENTATION AND APPROVAL GR 11085 DRO 11386 ETARY Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals Program Date Adobe Illustrator 10 0 eps s 4 05 n Rainbow Buttons 6 05 4 1 05 Marketing Communications Date During normal patient monitoring the Up and Down Arrow keys control the Pulse Tone volume At the lowest...

Page 40: ...mit GRAPHIC DOCUMENTATION AND APPROVAL GR 11085 DRO 11386 PROPRIETARY ation Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals s itle Program Date an Adobe Illustrator 10 0 eps Buttons 4 05 lustration Rainbow Buttons 6 05 4 1 05 Marketing Communications Date SpO2 Low Alarm Limit GRAPHIC DOCUMENTATION AND APPROVAL GR 11085 DRO 11386 PROPRIETARY ation Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals s itle ...

Page 41: ...M 1379 Rev A DRO 5201 Approvals Program Date Adobe Illustrator 10 0 eps uttons 4 05 ration Rainbow Buttons 6 05 4 1 05 Marketing Communications Date FastSat On Off GRAPHIC DOCUMENTATION AND APPROVAL GR 11085 DRO 11386 OPRIETARY n Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals Program Date Adobe Illustrator 10 0 eps uttons 4 05 ration Rainbow Buttons 6 05 4 1 05 Marketing Communications Date SmartTo...

Page 42: ... Use Up or Down Arrow Keys to adjust parameter measurement to desired setting DISPLAY DISPLAY GR 14946 IC 7362A RAD87 IC 7362A RAD87 FCC ID VKF RAD87 FCC ID VKF RAD87 Set Month DISPLAY DISPLAY GR 14946 IC 7362A RAD87 IC 7362A RAD87 FCC ID VKF RAD87 FCC ID VKF RAD87 Set Day DISPLAY DISPLAY GR 14946 IC 7362A RAD87 IC 7362A RAD87 FCC ID VKF RAD87 FCC ID VKF RAD87 Set Hour DISPLAY DISPLAY GR 14946 IC ...

Page 43: ...86 PRIETARY Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals Program Date Adobe Illustrator 10 0 eps tons 4 05 ation Rainbow Buttons 6 05 4 1 05 Marketing Communications Date PI allows the PI value to be shown on the Display Screen On Off RAPHIC DOCUMENTATION AND APPROVAL GR 11085 DRO 11386 PRIETARY Page 1 of 1 FRM 1379 Rev A DRO 5201 Approvals Program Date Adobe Illustrator 10 0 eps tons 4 05 ation ...

Page 44: ...umber Title Program Date Diana Yuan GR 11085 Adobe Illustrator 10 0 eps Illustration Rainbow Buttons 4 05 Illustration Rainbow Buttons 6 05 4 1 05 Marketing Communications Date button 5 times LF will be diplayed in the top LED display window and the active line frequency will be displayed in the lower LED display window 6 Push the Up arrow to set the line frequency to 60 Hz and the Down arrow to s...

Page 45: ...ASCII text out file available in upgraded Instrument TrendCom Utility Installation Copy the TrendCom utility from the CD onto a PC running MS Windows Refer to Trendcom Directions for Use for instructions Erasing Trend Memory To erase clear the trend memory turn the trend off and back on again Enabling trend setting Trend to ON will erase all trend data NOTE Turning trend off will not erase trend m...

Page 46: ... as follows 000 Normal 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 400 Low Signal IQ 800 Masimo SET This flag means the algorithm is running in full SET mode It requires a Masimo sensor and needs to acquire some clean data for this flag to be set O p...

Page 47: ...tically adjust to the next setting below the newly entered high alarm limit SpCO High Limit The SpCO high alarm limit can be set to Off or anywhere between 2 and 98 with a 1 step size In the Off setting the SpCO High Limit Alarm is disabled Factory default setting is 10 SpMet Low Limit The SpMet low alarm limit can be set to Off or anywhere between 0 1 and 99 The step size varies When the range is...

Page 48: ...the PVI Low Limit alarm is disabled PVI High Limit The PVI high alarm limit can be set to Off or anywhere between 2 and 99 Adjust in increments of 1 step size When PVI is placed in the Off setting the PVI High Limit alarm is disabled PI Low Limit The PI low alarm limit can be set to Off or anywhere between 0 03 and 18 Adjust in increments of 0 01 step size between 0 03 and 0 1 0 1 step size betwee...

Page 49: ...ing a patient acknowledging an alarm condition by pressing the Alarm Silence Button one time will silence the alarm tone for 120 seconds and the Alarm Silenced Indicator will flash Pressing the Alarm Silence Button a second time while the Alarm Silenced Indicator is still flashing will activate alarms and the alarm silence indicator will be off If the alarms have been silenced per Setup Menu Level...

Page 50: ...L BARS Pulse Search Wait for pulse detection This search should occur whenever a sensor is first applied to a patient If necessary shield the sensor from excessive ambient or strobing light CIRCULATING LEDS Sensor is calibrating LOW SIQ INDICATOR FLASHES Low Signal IQ 1 Rule out occlusion of blood flow 2 Verify placement of sensor PERFUSION INDEX PI BAR TURNS RED Bottom two LEDs only Low Signal St...

Page 51: ...le Replace adhesive sensor resposable RPL Reu Defective reusable sensor resposable Replace reusable sensor resposable INT DET Blinking Interference detected Ensure that the sensor is properly applied and cover the sensor site with opaque material if required INC SeN Incompatible sensor Unrecognized sensor Insert Masimo sensor INC Cbl Incompatible cable Unrecognized cable Insert Masimo cable INC ad...

Page 52: ...essage rPL CbL Cable life expired Replace cable as soon as possible Temporary blinking message rPL SEn Sensor life expired Replace sensor as soon as possible Temporary blinking message rPL AdH Adhesive sensor life expired Replace adhesive sensor as soon as possible CHc SEN Check sensor connection Reattach sensor available in upgraded Instrument ...

Page 53: ...nt properly Sensor is damaged Properly reapply the sensor on the patient and reconnect the sensor to the Instrument or patient cable If the sensor is damaged replace the sensor NO SENSOR MESSAGE Sensor is disconnected from patient cable Sensor connected upside down into patient cable Check to see if the sensor LED is flashing Disconnect and reconnect the sensor If the LED fails to operate replace ...

Page 54: ...test DIFFICULTY OR NO SpO2 SPCO SPMET READING Low battery not plugged into AC power supply Insert handheld into docking station verify docking station power cord plugged in and docking station power indicator light is illuminated Interference from line frequency induced noise Verify set 50 60hz menu setting Refer to Section 3 Initial Setup for details Inappropriate sensor or sensor size Verify pro...

Page 55: ...fants Pediatrics 2 Neonates 3 Motion3 Adults Infants Pediatrics Neonates 3 Low Perfusion4 Adults Infants Pediatrics Neonates 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 3 bpm Carboxyhemoglobin saturation accuracy SpCO 1 Adults Infants Pediatrics 1 40...

Page 56: ... 8 Operating Humidity 5 to 95 non condensing Operating Altitude 500 mbar to 1060 mbar pressure 1000 ft to 18 000 ft 304 m to 5 486 m PHYSICAL CHARACTERISTICS Dimensions 6 2 x 3 0 x 1 4 15 8 cm x 7 6cm x 3 6 cm Weight 13oz 0 37 kg SpO2 Modes Averaging mode 2 4 8 10 12 14 or 16 seconds8 Sensitivity Normal Maximum and APOD Alarms Audible and visual alarms for high low saturation and pulse rate SpO2 r...

Page 57: ...forming 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 hypoxia studies in the range of 70 100 SpO2 against a laboratory CO Oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population 4 The Rad 57 h...

Page 58: ...7 4 Rad 57 Signal Extraction Pulse CO Oximeter Operator s Manual 7 S p e c i f i c a t i o n s ...

Page 59: ...HESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS POTENTIALLY LEADING TO PATIENT HARM ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS VERIFY THE COMPATIBILIY OF THE MONITOR CABLE AND SENSOR BEFORE USE OTHERWISE PATIENT INJURY CAN RESULT Selecting a Sensor When selecting a sensor consider the patient s weight the adequacy of perfusion the available sensor sites and the duration...

Page 60: ... 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 1 R1 25L Finger or toe 30 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 1 R1 20 Finger or toe 10 50 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 1 R1 20 L Thumb or great toe 3 10 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 1 Finger or toe 10 30 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 1 Rainbow Adhesive Sensors SpO2 SpCO SpMet and pulse rate accuracy for the Rainbow se...

Page 61: ...wing table Rainbow reusable sensors must be used in conjunction with Rainbow RC cables Sensor Weight Range Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SpCO Accuracy SpMet Accuracy No Motion Motion No Motion Motion Saturation Pulse Rate No Motion No Motion DCI 30 kg 2 3 3 bpm 5 bpm 2 3 bpm 3 1 DCIP 10 50 kg 2 3 3 bpm 5 bpm 2 3 bpm 3 1 Rainbow Resposable Pulse CO Oximeter Sensor S...

Page 62: ...or Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy Range No Motion Motion No Motion Motion Saturation Pulse Rate LNOP DCI 30 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOP DCIP 10 50 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOP YI 1 kg 2 3 3 bpm 5 bpm N A N A LNOP TC I 30 kg 3 5 N A 3 bpm N A 3 5 3 bpm LNOP DC 195 30 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOP TF I 30 kg 2 N A 3 bpm N A 2 3 bpm NOTE The LNOP TF I a...

Page 63: ...30 kg 3 5 N A 3 bpm N A 3 5 3 bpm M LNCS LNCS TF I 30 kg 2 N A 3 bpm N A 2 3 bpm M LNCS LNCS YI 1 kg 2 3 3 bpm 5 bpm N A N A NOTE The M LNCS and LNCS TF I and TC I sensors were not validated under motion conditions M LNCS LNCS Adhesive Sensors M LNCS sensors must be used in conjuction with Rainbow patient cable series LNCS sensors must be used in conjunction with Red LNC cables SENSOR Weight Range...

Page 64: ...represent 1 standard deviation Plus or minus one standard deviation represents 68 of the population SpO2 accuracy from 70 to 100 Pulse Rate accuracy from 25 to 240bpm Carboxyhemoglobin accuracy SpCO from 1 to 40 Methemoglobin accuracy SpMet from 1 to 15 Cleaning And Reuse Of Masimo Reusable Sensors and Cables Reusable sensors and patient cables can be cleaned per the following procedure Remove the...

Page 65: ... with a mild soap and water Do not allow liquids to enter the interior of the Instrument CAUTIONS DO NOT AUTOCLAVE PRESSURE STERILIZE OR GAS STERILIZE THIS OXIMETER DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID USE THE CLEANING SOLUTION SPARINGLY EXCESSIVE SOLUTION CAN FLOW INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS DO NOT TOUCH PRESS OR RUB THE DISPLAY PANELS WITH ABRASIVE CLEANI...

Page 66: ...PERATING THE INSTRUMENT BELOW 5ºF 15º C DUE TO ALKALINE BATTERY TECHNOLOGY Battery charge level is indicated by four LED indicators at the bottom of the front panel All four indicators will be lit when the batteries are full with fewer indicators being lit as the batteries lose their charge When less than ten 10 percent battery life remains the final battery indicator will begin to flash and an au...

Page 67: ...iting for the normal time out S e r v i c e a n d R e p a i r Repair Policy Masimo or an authorized Service Department must perform warranty repair and service Do not use malfunctioning equipment Have the Instrument repaired Please clean contaminated dirty equipment before returning following the cleaning procedure described in Section 9 Cleaning Make sure it is fully dry before packing the equipm...

Page 68: ...about the repairs A certificate stating the oximeter has been decontaminated for bloodborne pathogens Return Rad 57 Pulse CO Oximeter to the following shipping address FOR USA CANADA ASIA PACIFIC EXCEPT JAPAN Masimo Corporation 40 Parker Irvine California 92618 Tel 949 297 7000 FAX 949 297 7001 FOR JAPAN Masimo Japan Corporation Kojimachi Office World Time Bldg 4F 10 7 Ichiban cho Chiyoda ku Tokyo...

Page 69: ...or maintenance needed because of a modification of the Product or Software without Masimo s written authorization b supplies devices or electrical work external to the Product or not manufactured by Masimo c disassembly or reassembly of the Product by anyone other than an authorized Masimo agent d use of the Product with sensors or other accessories other than those manufactured and distributed by...

Page 70: ...y physically transfer the products from one location to another provided that the Software is not copied Purchaser may not electronically transfer the software from the Product to any other device Purchaser may not disclose publish translate release or distribute copies of modify adapt translate reverse engineer decompile disassemble or create derivative works based on the Software or the written ...

Page 71: ... Rubber protective boot Yellow 1981 Rubber protective boot Red 1982 Rubber protective boot Orange 2097 Rubber protective boot Royal Blue 2098 Rubber protective boot Light Blue 2099 Rubber protective boot Pink 2208 Protective carrying case black 2209 Protective carrying case red 13158 Nylon protective carrying case 1908 CD TrendCom Software 2063 Data Transfer Download Cable ...

Page 72: ......

Page 73: ...38217 9204A 0216 www masimo com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo ...

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Masimo SET Rad-57, Operator'S Manual

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