OPERATOR’SMANUAL
Covers:Rad-57c:
with SpO2 and SpCORad-57m:
with SpO2 and SpMetRad-57cm:
with SpO2, SpCO
and SpMet
Signal ExtractionPulse CO-Oximeter
™
Masimo Rainbow
®
SET
Page 1: ...OPERATOR S MANUAL Covers Rad 57c with SpO2 and SpCO Rad 57m with SpO2 and SpMet Rad 57cm with SpO2 SpCO and SpMet Signal Extraction Pulse CO Oximeter Masimo Rainbow SET...
Page 2: ...Signal Extraction Pulse CO Oximeter OPERATOR S MANUAL...
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Page 4: ...297 7000 Fax 949 297 7001 www masimo com EU Authorized Representative for Masimo Corporation MDSS GmbH Schiffgraben 41 30175 Hannover Germany Tel 49 511 62 62 86 30 Fax 49 511 62 62 86 33 MEDICAL ELEC...
Page 5: ...o not open the Pulse CO Oximeter cover except to replace the batteries Only a qualified operator may perform maintenance procedures specifically described in this manual Refer servicing to Masimo for...
Page 6: ...ient Safety If a sensor is damaged in any way discontinue use immediately Disposal of product Comply with local laws in the disposal of the device and or its accessories The Pulse CO Oximeter can be u...
Page 7: ...nt motion 1 7 Masimo SET Parallel Engines 1 8 Masimo SET DST 1 8 SECTION 2 SYSTEM DESCRIPTION Introduction 2 1 Rad 57c Front Panel Controls 2 2 Rad 57m Front Panel Controls 2 4 Rad 57cm Front Panel Co...
Page 8: ...d Use 4 14 Introduction 4 14 TrendCom Utility Installation 4 14 TrendCom Utility Operation 4 14 Erasing Trend Memory 4 15 Trend Data Format 4 15 Sample Trend Output 4 16 SECTION 5 ALARMS MESSAGES Alar...
Page 9: ...4 Reattachment of Single Use Adhesive Sensors 8 4 SECTION 9 SERVICE MAINTENANCE Introduction 9 1 Cleaning 9 1 Battery Replacement 9 2 Performance Verification 9 3 Power On Self Test 9 3 Key Press But...
Page 10: ...to the safety section this manual 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...
Page 11: ...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 car...
Page 12: ...c Includes SpCO and PI Rad 57m Includes SpMet and PI Rad 57cm Includes SpCO SpMet and PI The following list outlines the key features and benefits of the Rad 57 Handheld Pulse CO Oximeter FEATURES AND...
Page 13: ...ate carboxyhemoglobin saturation measured by an SpCO SpMet sensor and methemoglobin saturation measured by a SpCO SpMet sensor The Rad 57 and accessories are indicated for use with adult pediatric and...
Page 14: ...its SpCO measurement The measurement is obtained by placing a sensor on a patient usually on the fingertip for adults and the hand or foot for infants The sensor connects either directly to the Pulse...
Page 15: ...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...
Page 16: ...oncentration As blood gas samples are usually taken over a period of 20 seconds the time it takes to draw the blood a meaningful comparison can only be achieved if the oxygen saturation carboxyhemoglo...
Page 17: ...lations Confidence Intermediate Calculations Confidence Intermediate Calculations Confidence Intermediate Calculations Confidence Intermediate Calculations Confidence Pre Processing Data Reduction Dig...
Page 18: ...The Rad 57 is powered by 4 AA alkaline batteries which provides a minimum of 8 hours of battery life Rad 57 offers full Masimo Rainbow SET Technology in a small hand held device Rad 57 supports the f...
Page 19: ...oxygen saturation is displayed in units of SpO2 When searching for a saturation and pulse it will flash dashed lines Refer to the Display Button description 4 SpCO Bar Illuminates when SpCO capable se...
Page 20: ...assessment of the perfusion at the monitoring site PI is displayed on a 10 segment LED bar ranging from 1 very weak perfusion to 5 strong perfusion The highest LED will remain lit continuously to allo...
Page 21: ...searching for a saturation and pulse it will flash dashed lines 4 SpMet Bar Illuminates when SpMet capable sensor is attached Bar will flash for SpMet alarm conditions Continuously indicates the conce...
Page 22: ...monitoring site PI is displayed on a 10 segment LED bar ranging from 1 very weak perfusion to 5 strong perfusion The highest LED will remain lit continuously to allow a PI level to be viewed The Perf...
Page 23: ...lobin oxygen saturation is displayed in units of SpO2 When searching for a saturation and pulse it will flash dashed lines See SpCO SpMet Button description below 4 SpCO Bar Illuminates when SpCO capa...
Page 24: ...cator Indicator above label will illuminate to provide an additional visual indication of the value currently being displayed 13 SpMet Bar Bar will flash for SpMet alarm conditions Continuously indica...
Page 25: ...P a n e l a l l m o d e l s CONTROL INDICATOR DESCRIPTION Serial Number Label Located on outside of case Agency Approvals Label Located on outside of case Battery Cover Located on back of device Batt...
Page 26: ...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 Underwriter s La...
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Page 28: ...t use any other type of batteries or power source to run the device The battery compartment is accessed from the back of the device To install the batteries first remove the battery cover by depressin...
Page 29: ...s a brief tone 4 Configure the device 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 Frequenc...
Page 30: ...patient adhesive or disposable sensor check that the emitter red light and the detector are properly aligned If using a reusable sensor make sure it opens and closes smoothly Remove any substances tha...
Page 31: ...onnect 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 monitoring a pati...
Page 32: ...rm limit Default is 10 Set to Pre Power Down Setting See Section 5 Alarm Limits for all settings SpCO low alarm limit Default is OFF SpMet high alarm limit Default is 3 Set to Pre Power Down Setting S...
Page 33: ...T IMMERSE THE SENSOR IN WATER SOLVENTS OR CLEANING SOLUTIONS THE SENSORS AND CONNECTORS ARE NOT WATERPROOF DO NOT STERILIZE BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE UNLESS OTHERWISE INDICATED...
Page 34: ...ally low arterial perfusion NUMERIC DISPLAY SpMet for applicable models A stable SpMet reading is associated with correct sensor placement small physiological changes during the measurement and accept...
Page 35: ...is indicated when the arterial pulsations are very low weak perfusion Low Perfusion is shown when the PI LED indicator bar does not exceed 0 25 on the Rad 57c and Rad 57m Low Perfusion on the Rad 57c...
Page 36: ...displayed on the screen in APOD or normal sensitivity mode This mode is not recommended for care areas where patients are not monitored visually such as general wards It is designed to interpret and...
Page 37: ...tely discontinue patient monitoring and replace the batteries NOTE Remove batteries when storing the device for prolonged periods to maintain battery life WARNING FAILURE TO REPLACE BATTERIES PROMPTLY...
Page 38: ...will enable the display of other parameters for 10 seconds In the event of a multi parameter alarm condition the SpO2 Pulse Rate display will take priority Rad 57cm Rad 57cm Pressing this button will...
Page 39: ...menu levels Within each level of the system the Next key is used to move from one option to the next The Up and Down arrow keys are used to select values within each option The parameter is set select...
Page 40: ...ones during excessive motion and low perfusion conditions The pulse tone is based off of an averaged pulse rate measurement from the proprietary algorithm and may not identify irregular heart beat pat...
Page 41: ...this setting Use Up or Down Arrow Keys to adjust parameter to desired setting Restore Factory Defaults Pressing a sixth time returns the Rad 57 to patient monitoring display in the Saturation Pulse Ra...
Page 42: ...y The default is set to 60 hz standard for the United States 1 Turn the Rad 57 on and wait for the displays to scroll through the current settings 2 Simultaneously press and hold the Up Arrow key and...
Page 43: ...ing MS Windows TRENDCOM UTILITY OPERATION 1 Disconnect patient cable from the Rad 57 2 Connect the mini D end of the Rad 57 PRONTO serial cable to the Rad 57 patient cable connector See Section 2 Rad...
Page 44: ...AMETER SPECIFICATION Date MM DD YY Time HH MM SS SpO2 001 to 100 or meaning parameter not available SpCO 00 00 to 100 or meaning parameter not available SpMet 00 00 to 100 or meaning parameter not ava...
Page 45: ...00 00 EXC 00000080 No Sensor 02 08 06 16 41 06 SpO2 000 PR 000 PI 00 00 SpCO 00 00 Met 00 00 EXC 00000080 No Sensor 02 08 06 16 41 08 SpO2 000 PR 000 PI 00 00 SpCO 00 00 Met 00 00 EXC 00000080 No Sens...
Page 46: ...ere between 1 and 100 with a 1 step size NOTE The low alarm limit must always be below the high alarm limit If the high alarm limit is set below the low alarm limit the low alarm limit will automatica...
Page 47: ...5 and 29 5 with a 5 step size In the off setting the SpMet Low Limit Alarm is disabled Factory default setting is off NOTE The low alarm limit must always be below the high alarm limit If the high al...
Page 48: ...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 Sile...
Page 49: ...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 L...
Page 50: ...l too low Replace batteries immediately No Cable Connected Connect appropriate cable to device System Fault Return for service There are several error codes All error codes require returning the devic...
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Page 52: ...es service The following chart describes what to do when encountering common problems PROBLEM POSSIBLE CAUSE S RECOMMENDATION SpO2 NUMBER FLASHES Saturation alarm limit exceeded Assess address patient...
Page 53: ...r sensor for patient size Verify proper sensor site UNEXPECTEDLY HIGH SpCO READING Possible elevated methemoglobin level Submit blood sample for laboratory CO Oximetry test DIFFICULTY OR NO SpO2 SPCO...
Page 54: ...Pediatrics 2 digits Neonate 3 digits Carboxyhemoglobin Saturation Accuracy SpCO 7 1 40 3 digits Methemoglobin Saturation Accuracy SpMet 8 1 15 1 digit Pulse Rate bpm during no motion conditions1 Adult...
Page 55: ...perating 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 Avera...
Page 56: ...s simulator with signal strengths of greater than 0 02 and a transmission of greater than 5 for saturations ranging from 70 to 100 This variation equals plus or minus one standard deviation which enc...
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Page 58: ...ROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS POTENTIALLY LEADING TO PATIENT HARM ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS VERIFY THE COMPATIBILITY OF THE MONITOR CABLE AND S...
Page 59: ...following table Sensor Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SpCO Accuracy SpMet Accuracy Range No Motion Motion No Motion Motion Saturation Pulse Rate No Motion No Mot...
Page 60: ...3 3 3 bpm 5 bpm 3 3 bpm LNOP NeoPt 1 kg 3 3 3 bpm 5 bpm 3 3 bpm LNOP Neo L 3 kg 3 3 3 bpm 5 bpm 3 3 bpm 40 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOP NeoPt L 1 kg 3 3 3 bpm 5 bpm 3 3 bpm LNOP Inf L 3 20 kg 2 3...
Page 61: ...umbers 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...
Page 62: ...mpened with a mild soap and water Do not allow liquids to enter the interior of the device CAUTIONS DO NOT AUTOCLAVE PRESSURE STERILIZE OR GAS STERILIZE THIS OXIMETER DO NOT SOAK OR IMMERSE THE MONITO...
Page 63: ...back into position WARNING FAILURE TO REPLACE BATTERIES PROMPTLY AFTER A LOW BATTERY ALARM MAY RESULT IN THE CO OXIMETER SHUTTING DOWN AND LEAVING THE PATIENT IN AN UNMONITORED CONDITION WARNING USE...
Page 64: ...acknowledges each key press with an audible beep tone or by indicating a change on the display ALARM LIMIT TEST 1 With the monitor turned on select the Menu Access key and enter the Alarm menu Change...
Page 65: ...Call Masimo at 800 326 4890 and ask forTechnical Support Ask for an RMA number Package the equipment securely in the original shipping container if possible and enclose or include the following inform...
Page 66: ...To request a replacement under warranty Purchaser must contact Masimo for a returned goods authorization If Masimo determines that a product must be replaced or repaired under warranty it will be repl...
Page 67: ...TO SUCH CLAIM THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT CANNOT LEGALLY BE DISCLAIMED BY CONTRACT E n d u s e r L i c e n s e 1 Grant of License In consideratio...
Page 68: ...urchaser transfer assign rent lease sell or otherwise dispose of the Product or the Software on a temporary basis Purchaser shall not assign or transfer this License in whole or in part by operation o...
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Page 70: ...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 b...
Page 71: ...www masimo com 31740 4517C 0709 Devices and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo...
