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Rad-87 Pulse CO-Oximeter Operators Manual Wireless Radio Addendum TABLE OF CONTENTS English............................................................... 1 French (Franais)................................................ 2 German (Deutsch).............................................. 3 Italian (Italian)..................................................... 4 Spanish (Espaol).............................................. 5 2 English Rad-87 Operators Manual Wireless Radio Addendum This addendum describes wireless radio licensing and specification information for the Rad-87 Pulse CO-Oximeter. This addendum is used in conjunction with revision E of the Rad-87 Operators Manual, part number 31374. PAGE i FCC ID: VKF-RAD87A IC ID: 7362A-RAD87A PAGE iii This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2, Medical Device Directive 93/42/EEC and Part 15, FCC Rules/USA. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. SECTION 7: SPECIFICATIONS Wireless Radio Specifications (if installed) Radio Modes Encryption 8802.11 a/b/g 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Open System, Shared Key, Pre-Shared Key (PSK), 802.1X:
LEAP, PEAP, TTLS, TLS, EAP-FAST Authentication Compliance USA Canada Europe FCC ID VKF-RAD87A FCC parts 15.207, 15.209, 15.247 and 15.407 IC ID 7362A-RAD87A RSS-210 EN 300 328 EN 301 893 EN 301 489-17 1 3 Franais (French) Addendum au manuel de lutilisateur du Rad-87 sur la radio sans fil Cet addendum traite de la license de la radio sans fil et des caractristiques du CO-oxymtre de pouls Rad-87. Cet addendum doit tre utilis conjointement avec la rvision A du manuel de lutilisateur du Rad-87, rfrence 32750. PAGE i FCC ID: VKF-RAD87A IC ID: 7362A-RAD87A PAGE iii Cet quipement a t test et dclar conforme aux limites applicables aux appareils mdicaux tablies par la norme EN 60601-1-2, la directive pour appareils mdicaux 93/42/CEE et les rgles FCC/USA, Partie 15. Cet appareil est conforme la section 15 des rgles de la FCC. Le fonctionnement est sujet aux deux conditions suivantes : (1) cet appareil ne doit pas causer dinterfrence nfaste, et (2) cet appareil doit accepter toutes les interfrences reues, y compris les interfrences qui peuvent causer un fonctionnement non dsir. SECTION 7: CARACTRISTIQUES Caractristiques de la radio sans fil (si installe) Modes uniquement radio Encryptage 8802.11 al/b/g 64/128-bit WEP, Dynamique WEP, WPA-TKIP, WPA2-AES Systme Ouvert, Clef Partage, Clef Pre-Partage (PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST FCC ID VKF-RAD87A FCC pices 15.207, 15.209, 15.247 et 15.407 IC ID 7362A-RAD87A RSS-210 EN 300 328 EN 301 893 EN 301 489-17 Authentification Conformit USA Canada Europe 2 Deutsch (German) Bedienungsanleitung fr die Erweiterung der W-LAN Funktion Dieser Anhang beschreibt die W-LAN Spezifikationen des Rad-87 Co-Oximeter. Dieser Anhang wird in Verbindung mit Neuausgabe A des Handbuches des Operators Rad-87, Teilenummer 32751 benutzt. SEITE i FCC ID: VKF-RAD87A IC ID: 7362A-RAD87A SEITE iii Dieses Gert wurde getestet und erfllt die Grenzwerte fr medizinische Gerte gem EN 60601-1-2, die Richtlinie ber Medizinprodukte 93/42/EWG entsprechend Teil 15 der US-amerikanischen FCC-Vorschriften. Das Gert hlt die Richtline Abschnitt 15 der FCC Verordnung ein. Whrend des Betriebs des Gertes werden zwei Voraussetzungen erfllt (1) das Gert verursacht keine gesund-
heitsschdlichen Interferenzen und (2) sonstige Interferenzen werden empfangen, diese haben aber keinen Ein uss fr die Funktion des Gertes. ABSCHNITT 7: SPEZIFIKATIONEN Drahtlose Funkspezifikationen (wenn sie angebracht werden) Funkmodi Verschlsselung 8802.11 a/b/g 64/128-bit WEP, Dynamisch WEP, WPA-TKIP, WPA2-AES Geffnetes System, Geteilter Schlssel, Pre-Geteilter Schlssel
(PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST Authentisierung Einhaltung der USA Kanada Europa FCC ID VKF-RAD87A FCC Teile 15.207, 15.209, 15.247 und 15.407 IC ID 7362A-RAD87A RSS-210 EN 300 328 EN 301 893 EN 301 489-17 3 Italiano (Italian) Rad-87 Operator addenda radiofonica senza li manuale Questo supplemento descrive le informazioni,le specifiche e le autorizzazioni di trasmissione radio per lossimetro Rad-87. Questo supplemento viene utilizzato insieme alla revisione la A del manuale delloperatore Rad-87, numero del pezzo 32752. PAGINA i FCC ID: VKF-RAD87A IC ID: 7362A-RAD87A PAGINA iii Questa apparecchiatura stata sottoposta a test risultando conforme ai limiti previsti per i dispositivi medici in base alla norma EN 60601-1-2, direttiva europea 93/42/CEE relativa ai dispositivi medici et Parte 15, disposizioni FCC/USA. Questo strumento segue le indicazioni - Parte 15- delle norme FCC (Commissione Federale Per Le Comunicazioni). Loperazione e soggetta alle due seguenti indica-
zioni (1) Questo strumento non puo in nessun caso causare interferenze dannose, inoltre (2) questo sturmento deve accettare ogni interferenza a cui puo essere sot-
toposto, incluse quelle interferenze che potrebbero causare operazioni indesiderate. SEZIONE 7: SPECIFICHE Specifiche radiofoniche senza fili (se installato) Modi radiofonici Crittografia 8802.11 a/b/g 64/128-bit WEP, Dinamico WEP, WPA-TKIP, WPA2-AES Sistema Aperto, Chiave Comune, Pre-Chiave Comune (PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST FCC ID VKF-RAD87A FCC parti 15.207, 15.209, 15.247 e 15.407 IC ID 7362A-RAD87A RSS-210 EN 300 328 EN 301 893 EN 301 489-17 Autenticazione Conformit USA Il Canada Europa 4 Espaol (Spanish) Anexo al manual de usuario del Rad 87 inalmbrico. Esta suplemento describe la informacin de radio sin hilos de la autorizacin y de la especifi-
cacin para el CO-Oxmetro del pulso Rad-87. Esta suplemento se utiliza conjuntamente con la revisin A del manual del operador Rad-87, nmero de parte 32753. PGINA i FCC ID: VKF-RAD87A IC ID: 7362A-RAD87A PGINA iii Este equipo fue sometido a pruebas y se determin que cumple con los lmites para dispositivos mdicos conforme a la norma EN 60601-1-2, y a la Directiva 93/42/EEC relativa a los dispositivos mdicos y con la Parte 15 de las reglas de la FCC (Comisin Federal de Comunicaciones) de Estados Unidos. Este dispositivo cumple con el Reglamento FCC. parte 15. Su funcionamiento est sujeto a las siguientes dos condiciones: (1) Este dispositivo no puede causar interfe-
rencias perjudiciales y (2) este dispositivo debe aceptar cualquier interferencia recibi-
da, incluidas interferencias que puedan causar un funcionamiento no deseado. SECCIN 7: ESPECIFICACIONES Especificaciones de radio sin hilos (si estn instaladas) Modos de radio Encripcin 8802.11 a/b/g 64/128-bit WEP, Dinmico WEP, WPA-TKIP, WPA2-AES Sistema Abierto, Llave Compartida, Pre-Llave Compartida
(PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST Autentificacin Conformidad USA Canad Europa FCC ID VKF-RAD87A FCC piezas 15.207, 15.209, 15.247 y 15.407 IC ID 7362A-RAD87A RSS-210 EN 300 328 EN 301 893 EN 301 489-17 5 Manufacturer:
EU Authorized Representative for Masimo Corporation:
EC REP MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33 Masimo Corporation 40 Parker Irvine, CA 92618 USA www.masimo.com 2008 Masimo Corporation. E 5 2 5 4 B A L
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1 2 | User Manual part 1 | Users Manual | 2.85 MiB |
Rad-87 Pulse CO-Oximeter OPERATORS MANUAL Rad-87 Pulse CO-Oximeter OPERATORS MANUAL The Rad-87 Operating Instructions provide the necessary information for proper operation of all models of the Rad-87 device. General knowledge of pulse CO-Oximetry and an understanding of the features and functions of the Rad-87 are a prerequisite for its proper use. Do not operate the Rad-87 without completely reading and understanding the instructions in this manual. NOTICE:
Purchase or possession of this device does not carry any express or implied license to use this device with replacement parts which would, alone or in combination with this device, fall within the scope of one of the patents relating to this device. CAUTION:
Federal law (U.S.) restricts this device to sale by or on the order of a physician. Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU Authorized Representative for Masimo Corporation:
EC REP MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33 CONFORMS 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, 7,215,984, 7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo. com/patents.htm. Other patents pending. 2008 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, Signal Extraction 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. Rad-87, Pleth Variability Index, PVI, Patient SafetyNet, RadNet, LNOPv and APOD are trademarks of Masimo Corporation. Rainbow SET, SpMet, SpHb, SpOC, Pulse CO-Oximeter and Signal Extraction Pulse CO-Oximeter are trademarks of Masimo Laboratories. Rad-87 Pulse CO-Oximeter Operators Manual i SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES The Rad-87 Pulse CO-Oximeter is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation. Explosion hazard. Do not use the Rad-87 in the presence of ammable anesthetics or other ammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not allow the Pulse CO-Oximeter to obtain readings. The Rad-87 is NOT intended for use as an apnea monitor. The Pulse CO-Oximeter should be considered an early warning device. As a trend towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patients condition. Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis. The Rad-87 is to be operated by quali ed personnel only. This manual, accessory directions for use, all precautionary information, and speci cations should be read before use. Electric shock hazard. Do not open the Rad-87 device. Only a quali ed operator may perform maintenance procedures speci cally described in this manual. Refer servicing to Masimo for repair of this equipment. As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Do not place the Rad-87 or accessories in any position that might cause it to fall on the patient. Do not lift the Rad-87 by the power cord or any other cable. Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter can not measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. 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. NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10%
to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 and SpCO measurements. Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements. Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO, SpHb and SpOC measurements. Motion artifact may lead to inaccurate SpMet, SpCO, SpHb and SpOC measurements. ii Rad-87 Pulse CO-Oximeter Operators Manual SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements. Severe anemia may cause erroneous SpO2 readings. Hemoglobin synthesis disorders may cause erroneous SpHb readings. Do not use the Rad-87 or sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Rad-87 may affect the MRI image and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements. If using Rad-87 during full body radiation, keep the sensor out of the radiation eld. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period. For home use, ensure that the Rad-87s alarm can be heard from other rooms in the house especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are operating. Always remove the sensor from the patient and completely disconnect the patient from the Rad-87 before bathing the patient. Additional information specific to Masimo sensors including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's Directions For Use
(DFU). Do not place the Rad-87 where the controls can be changed by the patient. Do not place the Rad-87's face against a surface. This will cause the alarm to be muf ed. Do not place the Rad-87 on electrical equipment that may 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 inaccurately or fail. Do not place containers with liquids on or near the Rad-87. Liquids spilled on the device may cause it to perform inaccurately or fail. If the Rad-87 fails any part of the setup procedures or leakage tests, remove the device from operation until quali ed service personnel have corrected the situation. Patient 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 Rad-87 can be used during de brillation, but the readings may be inaccurate for up to 20 seconds. This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B digital device, Part 15, FCC Rules/USA. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. Rad-87 Pulse CO-Oximeter Operators Manual iii SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving device. Increase the separation between the equipment. Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. Consult the manufacturer for help. In order to connect wirelessly to a compatible interface system like Patient SafetyNet, the Rad-87 should be placed in an environment free from RF shielding, which could hinder wireless reception. To minimize radio interference, other electrical equipment that emits RF transmissions should not be in close proximity to the RAD-87. Changes or modifications to the wireless radio feature whether intentional or unintentional are prohibited without written approval from Masimo Corporation. The Rad-87 (device with optional radio) wirelessly transmits real-time sensor connectivity status, indicating a connect and/or disconnect state. If the device is in a failure mode then the radio power is disabled and an error message is indicated on the device display. The device does not have a powered state where no information is transmitted. In accordance 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 with optional radio) cannot be attached directly to the patient using any accessory containing metal components. In accordance with international telecommunication requirements, the frequency band of 5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. The battery should be adequately charged to ensure backup power in case of AC power disruption. A functional tester cannot be utilized to assess the accuracy of the Pulse CO-Oximeter or any sensors. To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. Ensure the speaker is not covered or the device is placed face-down on bedding or other sound absorbing surface. To protect against injury from electric shock, follow the directions below:
Avoid placing the device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids. Always turn off and disconnect the power cord from the AC power supply before cleaning the device. Use cleaning solutions sparingly. iv Rad-87 Pulse CO-Oximeter Operators Manual t a b l e o f c o n t e n t s SECTION 1 - OVERVIEW About This Manual . 1-1 Warnings, Cautions and Notes. 1-2 Product Description . 1-3 Features . 1-3 Optional Features . 1-3 Indications for Use. 1-4 Pulse CO-Oximetry . 1-4 SpO2 General Description . 1-4 SpCO General Description . 1-4 SpMet General Description. 1-5 SpHb General Description . 1-5 Total Arterial Oxygen Content (SpOC) General Description. 1-5 Principle of Operation . 1-6 Functional Saturation . 1-7 Rad-87 vs. Drawn Whole Blood Measurements . 1-7 Masimo SET Signal Extraction Technology for SpO2 Measurements . 1-7 SpMet, SpCO, and SpHb and SpOC Measurements During Patient Motion . 1-7 Fastat . 1-7 Masimo 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 - SETUP Introduction. 3-1 Unpacking and Inspection . 3-1 Preparation for Monitoring . 3-1 Rad-87 Power Requirements . 3-1 Initial Battery Charging . 3-2 Initial Installation . 3-2 SECTION 4 - OPERATION Introduction. 4-1 Basic operation. 4-1 General Setup and Use. 4-1 Default Settings. 4-3 Factory Default and User Configurable Settings. 4-4 Successful Monitoring . 4-4 Masimo Pulse CO-Oximetry Sensors . 4-4 Numeric Display - SpO2 . 4-5 Numeric Display - Pulse Rate . 4-5 Numeric Display - SpCO. 4-5 Numeric Display - SpMet . 4-5 Numeric Display - SpHb . 4-6 Rad-87 Pulse CO-Oximeter Operators Manual v t a b l e o f c o n t e n t s SECTION 4 - OPERATION (CONTINUED) Numeric Display - SpOC. 4-6 Numeric Display - PI . 4-6 Pleth Variability Index (PVI). 4-7 Low Perfusion . 4-7 Signal SIQ . 4-7 Sensor Placement. 4-8 Sensitivity . 4-9 Low Battery Audible Alarm . 4-9 Normal Patient Monitoring . 4-9 Paramater/Measurement Selection. 4-11 Setup Menu. 4-12 Menu Navigation . 4-12 Setup Menu Level 1 . 4-13 Parameter/Measurement Alarm Limits - Screen 1 . 4-13 Parameter/Measurement Alarm Limits - Screen 2 . 4-14 Parameter/Measurement Alarm Limits - Screen 3 . 4-15 LED Brightness . 4-15 Sensitivity . 4-16 Setup Menu Level 2 . 4-17 Alarm Volume . 4-17 Alarm Silence . 4-17 Alarm Delay. 4-18 Clear Trend . 4-18 Button Volume . 4-19 FastSat . 4-19 Trend Setup and Use . 4-19 Introduction . 4-19 Trend Utility Installation . 4-19 Trendcom Utility Operation . 4-20 Erasing Trend Memory . 4-20 Trend Data Format . 4-21 Sample Trend Output. 4-21 Setup Menu Level 3 . 4-22 Averaging Time . 4-22 Rapid Desat Limit . 4-23 Alarm On/Off . 4-23 Out Put Data . 4-24 Default Settings. 4-24 Device Profile Setup and Use . 4-25 PVI Bar On/Off . 4-26 Smart Tone On/Off . 4-26 Year . 4-26 Month . 4-26 Day . 4-27 Hour. 4-27 Minute . 4-28 Software Version . 4-28 Serial Output . 4-29 vi Rad-87 Pulse CO-Oximeter Operators Manual t a b l e o f c o n t e n t s SECTION 4 - OPERATION - (CONTINUED) Interface Alarms . 4-29 System Interfaces. 4-29 Philips VueLink Set . 4-29 Radnet Setup . 4-30 Patient SafetyNet Setup . 4-30 Nurse Call . 4-31 Polarity. 4-31 Line Frequency . 4-31 Parameter/Measurement Select - Screen 1 . 4-32 Parameter/Measurement Select - Screen 2 . 4-32 Parameter/Measurement Select - Screen 3 . 4-33 LCD Language . 4-33 Set Mode. 4-33 Home Mode Operation. 4-34 Sleep Mode Operation . 4-34 Enable/Disable Radio . 4-34 LCD Display Function with Radio Configured and Enabled . 4-35 SECTION 5 - ALARMS AND MESSAGES Alarm Identification. 5-1 Alarm Indication . 5-1 Alarm Limits . 5-2 Alarm Limit: User Configurable Settings . 5-2 Alarm Limit: Factory Default Settings . 5-3 Single Alarm Features . 5-4 Multi-Parameter/Measurement Alarm Features . 5-4 Alarm Priority for Display Screens . 5-4 Alarm Silence . 5-5 Alarm Bell . 5-5 System Status Light . 5-5 Alarm Mute. 5-6 Messages . 5-7 SECTION 6 - TROUBLESHOOTING Troubleshooting . 6-1 SECTION 7 - SPECIFICATIONS Rad-87 Specifications . 7-1 Performance . 7-1 Accuracy . 7-1 Electrical . 7-2 Environmental . 7-2 Physical Characteristics . 7-2 Serial Interface Specifications. 7-4 Serial Interface Setup . 7-4 Serial Printer Setup. 7-5 Nurse Call Specifications . 7-5 Nurse Call . 7-5 Rad-87 Pulse CO-Oximeter Operators Manual vii t a b l e o f c o n t e n t s SECTION 8 - SENSORS & PATIENT CABLES Introduction. 8-1 Selecting a Masimo SET Sensor . 8-1 Sensor Application Instructions. 8-1 Masimo Rainbow Sensors . 8-2 Rainbow Reusable Sensors . 8-2 Rainbow Direct Connect Sensors . 8-2 Masimo SpO2 Sensors . 8-3 Red Direct Connect Sensors . 8-3 LNOP Reusable Sensors . 8-3 LNOP Adhesive Sensors. 8-4 LNOPvTM Adhesive Sensors . 8-4 LNOP Specialty Sensors . 8-4 LNCS Reusable Sensors . 8-4 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 Single Use Adhesive Sensors . 8-6 SECTION 9 - SERVICE AND MAINTENANCE Introduction. 9-1 Cleaning . 9-1 Battery Service and Performance Verification . 9-2 Service and Repair. 9-4 Repair Policy . 9-4 Return Procedure . 9-4 Sales & End-user License Agreement . 9-5 Warranty . 9-5 Exclusions . 9-5 End-user License . 9-6 Restrictions. 9-6 SECTION 10 - PART NUMBERS Part Numbers . 10-1 viii Rad-87 Pulse CO-Oximeter Operators Manual o v e r v i e w 1 A b o u t T h i s M a n u a l This manual explains how to set up and use the Rad-87 Pulse CO-Oximeter containing Masimo Rainbow SET technology. Important safety information relating to general use of the Rad-87 appears before this introduction. Other important safety information is located throughout the manual where appropriate. Read the entire safety information section before you operate the monitor. In addition to the safety section, this manual includes the following sections:
SECTION 1 SECTION 2 SECTION 3 SECTION 4 SECTION 5 SECTION 6 SECTION 7 SECTION 8 SECTION 9 SECTION 10 OVERVIEW gives a general description of Rad-87 Pulse CO-Oximeter. SYSTEM DESCRIPTION describes the Rad-87 Pulse CO-Oximeter system and its functions and features. SETUP describes how to setup the Rad-87 Pulse CO-Oximeter for use. OPERATION describes the operation of the Rad-87 Pulse CO-Oximeter system. ALARMS AND MESSAGES describes the alarm system messages. TROUBLESHOOTING describes troubleshooting information. SPECIFICATIONS gives the detailed speci cations of the Rad-87 Pulse CO-Oximeter. SENSORS & PATIENT CABLES outlines how to use and care for Masimo Rainbow SET technology sensors, Masimo Rainbow SET technology patient cables, Masimo Red sensors and, Masimo Red PC cables. SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Rad-87 Pulse CO-Oximeter. ACCESSORIES lists CO-Oximeter. the available models of the Rad-87 Pulse Rad-87 Pulse CO-Oximeter Operators Manual 1-1 1 o v e r v i e w W a r n i n g s , C a u t i o n s a n d N o t e s Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows:
A WARNING is provided when actions may result in a serious 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 device or damage to other property. Sample of Caution:
CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when extra general information is applicable. Sample of Note:
NOTE: This is a sample of a Note. 1-2 Rad-87 Pulse CO-Oximeter Operators Manual o v e r v i e w 1 P r o d u c t D e s c r i p t i o n The Rad-87 Pulse CO-Oximeter Monitor is a noninvasive, arterial oxygen, carboxyhemoglobin and methemoglobin saturation, total hemoglobin concentration, total arterial oxygen content and pulse rate monitor. The Rad-87 features a multicolored LED display that continuously displays numeric values for SpO2, SpCO*, SpMet*, SpHb*, total arterial oxygen content (SpOC*), perfusion index (PI), pleth variability index* (PVI) and pulse rate. It also provides bar graph displays for quick visual identi cation of Signal Identi cation Quality (SIQ), perfusion index and pleth variability index. The Rad-87 is available in four models: vertical Rad-87, horizontal Rad-87, vertical Rad-87 with radio and horizontal Rad-87 with radio. FEATURES These features are common to Rad-87 monitors:
Masimo SET is clinically proven to be the highest sensitivity and speci city pulse oximeter technology in the world. Rainbow technology continuously and noninvasively measures arterial oxygen saturation (SpO2) and pulse rate (BPM), as well as providing a reliable probe-off detection. Perfusion Index (PI) with trending capability indicates arterial pulse signal strength during low Accurate on cyanotic infants with congenital heart disease when used with an LNOP Blue perfusion. Sensor. Signal IQ provides signal identi cation and quality indication during excessive motion and low signal to noise situations. FastSat tracks rapid changes in arterial O2 saturation with high fidelity. Variable pitch provides tonal variance for every 1% change in saturation. Remote alarming interface. Up to 72 hours of trending. (See Section 4, Trends Setup and Use.) Allows user to customize the default settings and set the device to retain these settings through a power off/on cycle. The LCD Display allows the user to view a scrolling marque of (installed) parameter/measurement alarm limits, system information, and wireless radio communication (wireless radio model only). OPTIONAL FEATURES Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively measure carboxyhemoglobin (SpCO), methemoglobin (SpMet) and total hemoglobin
(SpHb), as well as providing a reliable probe-off detection. Pleth Variability Index (PVI) may show changes that re ect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.1 Total arterial oxygen content (SpOC) provides a calculated measurement of the amount of oxygen in arterial blood which may provide useful information for both oxygen dissolved in plasma and combined with hemoglobin. Provides a 802.11a/b/g wireless radio which interfaces with compatible systems (wireless radio Ability to connect to Masimo Patient SafetyNet through a wireless network (wireless radio model only) model only). 1 The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion.
*Optional features: SpCO, SpMet, SpHb, SpOC, PVI Rad-87 Pulse CO-Oximeter Operators Manual 1-3 1 o v e r v i e w INDICATIONS FOR USE The Rad-87 Pulse CO-Oximeter and accessories are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin and methemoglobin concentration expressed in percentage (SpCO and SpMet) and total hemoglobin concentration expressed in grams per deciliter (SpHb).The Rad-87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, who are well or poorly perfused patients in hospitals, hospital-type facilities, mobile and home environments. P u l s e C O - O x i m e t r y SpO2 GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and noninvasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the ngertip for adults and the hand or foot for neonates. The sensor is connected to the Pulse CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The following gure shows the general monitoring setup. 1 2 3 NORM APOD MAX SENSITIVITY MODE 97 76 10.1 rbc monitor 1. Instrument 2. Patient Cable 3. Sensor SpCO GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement. The measurement is obtained by placing a sensor on a patient, usually on the ngertip 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 instrument displays the calculated data as percentage value for the SpCO, which re ect blood levels of carbon monoxide bound to hemoglobin. SpMet GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is obtained by placing a sensor on a patient, usually on the ngertip 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 instrument displays the calculated data as percentage value for the SpMet. TOTAL HEMOGLOBIN (SpHb) GENERAL DESCRIPTION 1-4 Rad-87 Pulse CO-Oximeter Operators Manual o v e r v i e w 1 Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin
(SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make the SpHb measurement. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adults and pediatric patients. The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as measurement of total hemoglobin concentration. The Rad-87 can be configured to be a combined SpO2 monitor with other available parameters/measurements. TOTAL ARTERIAL OXYGEN CONTENT (CaO2) GENERAL DESCRIPTION2 Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content (CaO2) and is measured in units of ml O2/dl blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3 ml of oxygen. The oxygen content is determined mathematically as:
CaO2 = 1.34 (ml O2/g Hb) x Hb (g/dl) x HbO2 + PaO2 (mm Hg) x (0.3 ml O2/ 100 mm Hg/dl) Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the partial pressure of arterial oxygen. For typical PaO2 values, the second part of the above equation [PaO2 (mm Hg) x (0.3 ml O2/ 100 mm Hg/dl] is approximately 0.3 ml/dl. Furthermore, for typical carboxyhemoglobin and methemoglobin levels, the functional saturation (SpO2) as measured by a pulse oximeter is given by:
SpO2 = 1.02 x HbO2 2 Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition. New York: Lippincott Williams & Wilkins, 1999. SpOC General Description (Pulse CO-Oximetry) The above approximations result in the following reduced equation for oxygen content via the Pulse CO-Oximeter:
SpOC (ml/dl*) = 1.31 (ml O2/g Hb) x SpHb (g/dl) x SpO2 + 0.3 ml/dl
*When ml O2/g Hb is multiplied by g/dl of Hb, the gram unit in the denominator of ml/g cancels the gram unit in the numerator of g/dl resulting in ml/dl (ml of oxygen in one dl of blood) as the unit of measure for SpOC. Rad-87 Pulse CO-Oximeter Operators Manual 1-5 1 o v e r v i e w PRINCIPLE OF OPERATION Pulse CO-Oximetry is governed by the following principles:
1.
(oxygenated blood), deoxyhemoglobin Oxyhemoglobin
(non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light
(using spectrophotometry, see gure below).
) m m
1
n o i t p r o s b A 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0 600 Absorption Spectra Carboxyhemoglobin Oxyhemoglobin Methemoglobin Deoxyhemoglobin Plasma 800 1000 1200 1400 1600 Wavelength (nm) 2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, 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, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. The Rad-87 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a photodiode (detector). See gure below. Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a ngertip, 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-87 for calculation. 1 2 1. Light Emitting Diodes (LEDs)
( 7+ wavelengths ) 2. Detector Once the Rad-87 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patients functional arterial oxygen saturation, blood levels of carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pulse rate. The SpCO and SpMet measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin in arterial blood. In an ambient temperature of 35 C the maximum skin surface temperature has been measured at less than 106 F (41 C), veri ed by Masimo sensor skin temperature test procedure. 1-6 Rad-87 Pulse CO-Oximeter Operators Manual o v e r v i e w 1 FUNCTIONAL SATURATION The Rad-87 is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. RAD-87 vs. DRAWN WHOLE BLOOD MEASUREMENTS When SpO2, SpCO, SpMet and SpHb measurements obtained from the Rad-87 (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2, SpCO, SpMet and SpHb measurements of the Rad-87 Pulse CO-Oximeter. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial 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 elevated. High levels of bilirubin may cause erroneous SpO2, SpMet, SpCO and SpHb readings. As blood 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, carboxyhemoglobin and methemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry measurements of SpO2, SpCO, SpMet and SpHb may vary with the rapid administration of uids 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 Signal Extraction Technologys signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital ltering. Adaptive lters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform
(DST) reliably identi es the noise, isolates it and, using adaptive lters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor. SpMet, SpCO, AND SpHb MEASUREMENTS DURING PATIENT MOTION The Rad-87 displays measurements of SpCO, SpMet and SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion. When the Rad-87 does not have 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 enables rapid tracking of arterial oxygen saturation 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 saturation values providing an averaged saturation value that is a better representation of the patients current oxygenation status. With FastSat, the averaging time is dependent on the input signal. Rad-87 Pulse CO-Oximeter Operators Manual 1-7 1 MASIMO RAINBOW SET PARALLEL ENGINES This gure is for conceptual purposes only. 12 FST MST MASIMO SET DST SpOC 1-8 Rad-87 Pulse CO-Oximeter Operators Manual s y s t e m d e s c r i p t i o n 2 I n t r o d u c t i o n The Rad-87 Pulse CO-Oximeters are full featured devices designed for ease of operation. All pulse CO-Oximetry measurement information, as well as device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel. The sensor cable connections are located on the left 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 supports the full line of Masimo sensors and patient cables (see Section 8, Sensors and Patient Cables) Rad-87 supports standardization of sensors, and pulse CO-Oximetry technology throughout the hospital The LCD Display identifies system settings, monitoring modes, alarm limits and information from Patient SafetyNet or Philips VueLink (when connected). The LCD is located on top of the device (Horizontal) or on the left of the device (Vertical). Rad-87 Pulse CO-Oximeter Operators Manual 2-1 2 s y s t e m d e s c r i p t i o n RAD-87 PULSE CO-OXIMETER - HORIZONTAL 1 2 3 4 5 6 7 8 9 10 11 NORM NORM NORMNORM NORMNORM APOD APOD APOD APOD APOD APOD MAX MAX MAXMAX MAXMAX SENSITIVITY SENSITIVITY SENSITIVITY SENSITIVITY MODE MODE DISPLAY DISPLAY 10.1 ENTER ENTER Rad-87 Rad-87 rbc monitor rbc monitor 20 19 18 17 16 15 14 13 12 CONTROL / INDICATOR DESCRIPTION Device Profile LED The Device Profile LED illuminates when the device has been set to user configured "default" settings. Upon power up, the user configured default settings are retained and the Device Profile LED remain lit. When user configured default settings are active, any changes to the default settings cause the Device Profile LED to turn off until the device is returned to the user configured default settings or powered off. Sensitivity Button/Indicator Used to set the device into Maximum Sensitivity, Normal Sensitivity, or APOD Mode. 1 2 3 LCD Display 1234567890123456 0123456789123456 4 Signal IQ Index The LCD display identifies system settings, monitoring modes, alarm limits, and information from Patient SafetyNet or Philips VueLink (when connected.) The Signal IQ provides an indication of the quality of the acquired signal as well as the timing of the pulse. A green vertical LED bar rises and falls with the pulse, where the height of the bar indicates the quality of the signal. 5 Perfusion Index The Perfusion Index provides an indication of the percentage of pulsatile signal to non pulsatile signal. 2-2 Rad-87 Pulse CO-Oximeter Operators Manual s y s t e m d e s c r i p t i o n 2 CONTROL / INDICATOR DESCRIPTION 6 Wireless Indicator 7 Alarm Limits Button 8 Display Button DISPLAY DISPLAY Off: No connection to Masimo Patient SafetyNet or other compatible interface system. Flashing Green: Rad-87 attempts to connect to Patient SafetyNet or other compatible interface system. Solid Green: Rad-87 is connected to the Patient SafetyNet or other compatible interface system. Used to enter the alarm menu to adjust Hi/Low SpO2, SpCO, SpMet, SpHb, PI, PVI and pulse rate alarm limits. The LED indicator (located above the Alarm Limits Button) will illuminate when one or more of the factory default alarm settings is changed to alert the user to verify alarm settings. Allows movement through the 3 different display screens to view sets of parameters 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 Bell The Alarm Bell flashes red to indicate a high priority alarm. 10 Alarm Silence Button 11 System Status Light Press the Alarm Silence Button to temporarily silence patient and low battery alarms. Press the Alarm Silence Button when the SEN OFF message is flashing (i.e. the sensor is removed from the patient) to acknowledge the end of monitoring. In this state, all further alarms are silenced until the Pulse CO-Oximeter starts measuring patient parameters/
measurements again. NOTE: The alarm silence time can be set for 120, 90, 60 and 30 seconds. See Section 4 - Setup Menu Level 2. Solid Green: Collecting data, no alarms. Solid Yellow:
1. low priority alarms. 2. Not monitoring and no alarms. 3. Sleep Mode. 4. Interface Alarms "Off". Flashing Yellow:
1. Low parameter/measurement confidence. 2. Medium priority alarms. Flashing Red: High priority alarms. Rad-87 Pulse CO-Oximeter Operators Manual 2-3 2 s y s t e m d e s c r i p t i o n CONTROL / INDICATOR DESCRIPTION 12 Enter Button 13 Brightness Button 14 Up Button Down Button 15 Pleth Variability Index 16 Battery Charge Level Indicator 17 AC Power Indicator 18 Power Button 19 Pulse CO-Oximeter Patient Cable Connector 20 Speaker Used to enter the setup menus and to select/activate certain entries within the menu/setup system. Controls the level of the brightness for the LED display by providing 4 levels of brightness. Each press of the button increases the brightness one level. Once level 4 is accessed, an additional press of the button returns the brightness to level 1. Use these buttons to adjust the volume of the pulse beep tone. Within the menu/setup system, these buttons are used to select values within each menu option or the numeric value for the parameter/measurement alarm feature. Pressing and holding down these buttons allow for the rapid scrolling of alarm limits. 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 measurement. the PVI numeric toggle to to Provides a visual representation of the battery charge status. When unplugged, bars illuminate to indicate battery charge. As the battery discharges power, bar illumination decreases from right to left. A low battery status is indicated by a low audible beep and the first battery bar to the left flashing green. The AC Power Indicator is illuminated when the Rad-87 is connected to AC power and during battery charging. Used to turn the device on and off. Press the button once to power on the device. Press the button for 2 seconds to power off the device. Connects to a Masimo Pulse CO-Oximeter sensor or Masimo Pulse CO-Oximeter Patient Cable with a sensor. Provides audible indication of alarm conditions, pulse tone and feedback for key-presses. 2-4 Rad-87 Pulse CO-Oximeter Operators Manual s y s t e m d e s c r i p t i o n 2 RAD-87 PULSE CO-OXIMETER - VERTICAL 11 8 4 15 2 18 3 17 16 9 10 5 7 13 12 6 14 1 20 8 8 8 8 8 8 8 8 8 8 8 8 97 8 8 8 8 8 8 76 10.1 8 8 8 8 8 8 8 8 8 8 8 8 NORMNORM MAXMAX 19 Rad-87 Pulse CO-Oximeter Operators Manual 2-5 2 s y s t e m d e s c r i p t i o n RAD-87 REAR PANEL 1 2 P1 4 RS-232 P2 Made in USA Manufactured by:
Masimo Corporation Irvine, CA 92618 USA 100-240v~50-60 Hz 15VA MAX 100-240v~50-60 Hz 15VA MAX Distributed by:
Masimo Corporation Irvine, CA 92618 USA 7 0 2 1
A 8 7 7 4
4 9 2 2 3 Rx Only Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215,986, 7,215,984, 7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents. Other patents pending. 3 1 2 3 4 NURSE CALL CONNECTOR SERIAL OUTPUT CONNECTOR POWER ENTRY MODULE EQUIPOTENTIAL GROUND CONNECTOR Use the 1/4 round Connector to interface with a nurse call system. This is a stereo output and should be utilized with a stereo cable. All external device connections to the Nurse Call Connector must be IEC-60950 compliant. Use the Serial Output Connector to connect a serial device, including a serial printer, RadNet Interface Module, or PC, to the Rad-87. See Section 7, Output Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant. The power entry module contains the input connector for AC power. The AC input provides power to the system from the AC line. Always connect the Rad-87 to the main power for continuous operation and/
or battery recharging. Use the Equipotential Ground Connector for grounding. 2-6 Rad-87 Pulse CO-Oximeter Operators Manual s y s t e m d e s c r i p t i o n 2 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
+70 C
-40 C
+1060 hPa - +500 hPa 795 mmHg - 375 mmHg Storage humidity range: 5% to 95%
Storage temperature range: +70C to -40C 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 De brillation Proof Type BF Caution Electrical Testing Laboratory certification Rad-87 Pulse CO-Oximeter Operators Manual 2-7 2 s y s t e m d e s c r i p t i o n LCD DISPLAY The LCD Display shows radio communication information when radio communication is active
(wireless radio model only). It also shows system information. All Rad-87 models are equipped with a LCD display which is located on the top panel of a horizontal model, or on the left side panel of a vertical model. The LCD Display illuminates upon start up and displays the installed parameter/measurement's low and high alarm limits. Once the Rad-87 completes system initiation, the display light turns off. As the front panel buttons are pressed, each menu selection is shown on the LCD Display. When Rad-87 actively communicates with another system using the radio feature, the LCD Display shows the following:
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". NOTE: When the Rad-87 is interfaced to the Philips VueLink and the LCD Display shows
"SpO2 & PR AL On", SpO2 and BPM audible alarms are active at the device and patient monitor. When the LCD Display shows "SpO2 & PR AL Off", SpO2 and BPM audible alarms are inactive at the device but active at the patient monitor. Label: System Settings Additionally, if the Display Button is pressed down for 5 seconds, the LCD Display shows the following settings three times and then returns to the default screen. The display cycle can be interrupted by pressing any button except for the Sensitivity or the Alarm Silence Buttons. Monitoring Mode: Normal, Sleep or Home Installed parameter/measurement's low and high alarm limits Audible Alarm Alarm Volume Alarm Silence Alarm Delay Rapid Desat Sensitivity Averaging Time 2-8 Rad-87 Pulse CO-Oximeter Operators Manual s e t u p 3 I n t r o d u c t i o n Before the Rad-87 Pulse CO-Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be fully charged. U n p a c k i n g a n d i n s p e c t i o n Remove the instrument from the shipping carton and examine it 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 Repair. P r e p a r a t i o n f o r m o n i t o r i n g The following sections of the manual describe the preparation, set-up and initial installation of the Rad-87 Pulse CO-Oximeter. RAD-87 POWER REQUIREMENTS 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 frequency before use. Verify that the power source can provide adequate power rating as indicated on the rear panel of the Rad-87. The Rad-87 is designed to operate on 100 to 240VAC, 47-83 Hz. The device is rated at 15 VA max. Connect a hospital grade power cable to the power entry module of the Rad-87 device(IEC-320 connector type at the device). Connect the power cable to an AC power source. Ensure that the device is adequately powered by verifying that the AC power indicator on the Rad-87 is illuminated. CAUTION:
CONNECT THE RAD-87 ONLY TO A HOSPITAL-GRADE RECEPTACLE (FOR HOSPITAL USE). DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR FROM THE POWER PLUG. DO NOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE. THE POWER CORD AND PLUG MUST BE INTACT AND UNDAMAGED. USE THE POWER CORD AS THE MEANS TO DISCONNECT THE DEVICE FROM THE MAINS POWER SUPPLY. IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH CONDUCTOR ARRANGEMENT, OPERATE THE RAD-87 ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY FUNCTIONAL. TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS. DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR DIMMER. Rad-87 Pulse CO-Oximeter Operators Manual 3-1 3 s e t u p INITIAL BATTERY CHARGING Before use, the Rad-87 battery needs to be fully charged. To charge the internal battery, connect the AC power cord to an AC outlet and to the Power Entry Module located on the back of the Rad-87. The AC Power Indicator illuminates. The AC Power Indicator will remain illuminated while the battery is charging. The Battery Charge Level Indicator will not be illuminated unless the device is operating on battery power. Once the battery is fully charged, the device has up to 4 hours of battery life. See Section 7-2, Specifications. INITIAL INSTALLATION Place the Rad-87 on a stable hard flat surface near the patient. Always place the Rad-87 on a dry surface. Maintain a minimum of 1 inch (2.54 cm) free space around the 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 CONDITIONS TEMPERATURE HUMIDITY OPERATING ALTITUDE
+5C to +40C, +41F to +104F 5% to 95%, non-condensing 500 mbar to 1060 mbar pressure
-1000 ft to 18,000 ft (-304 m to 5,486 m) Configure the Rad-87 for your regional power line frequency (50 or 60 hz) if needed. Default Configure the Rad-87 for your regional power line frequency (50 or 60 hz) if needed. Default is 60 hz (standard for the United States). See Section 4, is 60 hz (standard for the United States). See Section 4, Operation, Setup menu Level 3, Line Operation, Setup menu Level 3, Line Frequency. Frequency. CAUTION:
CAUTION: TTHE DEVICE MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE HE DEVICE MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORESCENT LIGHTS AND OTHER SOURCES. BY FLUORESCENT LIGHTS AND OTHER SOURCES. CAUTION:
CAUTION: THE BATTERY SHOULD BE ADEQUATELY CHARGED TO ENSURE BACKUP THE BATTERY SHOULD BE ADEQUATELY CHARGED TO ENSURE BACKUP POWER IN CASE OF AC POWER DISRUPTION. POWER IN CASE OF AC POWER DISRUPTION. 3-2 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 I n t r o d u c t i o n To operate the Rad-87 system effectively, the device must be set up correctly and the operator must:
Know how the Rad-87 derives its readings (see Section 1). Be familiar with its controls, components and operation. Understand its status and alarm messages (see Section 5, Alarm and Messages and Section 6, Troubleshooting). B a s i c o p e r a t i o n GENERAL SETUP AND USE 1. 2. Connect a patient cable or a direct connect sensor to the Rad-87 device. Make sure it is a firm Inspect the Rad-87 case for damage. connection and the cable is not twisted, sliced or frayed. If utilizing a patient cable, select a sensor that is compatible with the Rad-87 and the patient before connecting it to the patient cable. See section 8, 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 sensors light source and detector. 3. 4. Refer to the Directions for Use of the sensor before attaching the sensor to the patient. 5. Attach the sensor to the Patient. With a Masimo sensor, connect the sensor to the patient cable with the logos lining up; make sure it is a firm connection. 6. Press the Power button to turn the Rad-87 on. 7. 8. Verify the front-panel display is free of alarm and system failure messages (see Section 5, Verify all front-panel indicators momentarily illuminate and a tone is heard. Alarms and Messages). NOTE: The number "0" scrolls across the screen as the system calibrates and obtains patient data (approximately 20 seconds). 9. Verify the LED and the LCD displays shows the following (see Setup Menu Level 1;
Parameter/Measurement Alarm Limits - Screen 1, Parameter/Measurement Alarm Limits -
Screen 2, Parameter/Measurement Alarm Limits - Screen 3, and Setup Menu Level 3; Set Mode located in this chapter):
Mode setting: Standard (Std) or Sleep (SLP) or Home (Hnn) SpO2 Low Alarm Limit and SpO2 High Alarm Limit, Pulse Rate Low Alarm Limit and Pulse Rate High Alarm Limit, SpCO Low Alarm Limit and SpCO High Alarm Limit, SpMet Low Alarm Limit and SpMet High Alarm Limit, SpHb Low Alarm Limit and SpHb High Alarm Limit, PI Low Alarm Limit and PI High Alarm Limit, PVI Low Alarm Limit and PVI High Alarm Limit. Measurement Alarm Limits - Screen 2, Parameter/Measurement Alarm Limits - Screen 3 in this chapter). NOTE: The number "0" scrolls across the screen as the system calibrates and obtains patient data (approximately 20 seconds). Rad-87 Pulse CO-Oximeter Operators Manual 4-1 4 o p e r a t i o n B a s i c o p e r a t i o n c o n t i n u e d 10. On the LED and the LCD displays, verify the alarm limit settings (see Setup Menu Level 1, Parameter/Measurement Alarm Limits - Screen 1, Parameter/Measurement Alarm Limits -
Screen 3 in this chapter). NOTE: The number "0" scrolls across the screen as the system calibrates and obtains patient data (approximately 20 seconds). 11. Verify that the patient alarms are functional by setting the high and low alarm limits beyond the patient readings. (see Setup Menu Level 1, Parameter/Measurement Alarm Limits -
Screen 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 Light flashes red for high priority alarms, flashes yellow for medium priority alarms and is solid yellow for low priority alarms. The number value and parameter/measurement label for the violated alarm limit will flash on the LED display. The alarm tone sounds. The Alarm Bell flashes red. The System Status Light flashes red. The display shows "SEN OFF" message. Remove the sensor from the sensor site. 12. Verify the sensor alarms are functional. Disconnect the sensor from the patient cable or Rad-87. The alarm tone sounds. The Alarm Bell flashes red. The System Status Light flashes red. The display shows "NO SEN" message. NOTE: "NO SEN" or "SEN OFF" conditions will only generate a high priority alarm if the Rad-87 is actively monitoring a patient when the sensor is disconnected. 13. Verify that the audible alarm can be silenced when a parameter/measurement alarm is exceeded. Create an alarm condition by lowering the high alarm limit for the pulse rate so that it is lower than the patient value. Press the Alarm Silence button. The alarm tone ceases for 120 seconds (default). The Alarm Bell flashes red for a high pulse rate (high priority alarm). The System Status Light flashes red. 14. To begin patient monitoring:
Adjust the alarm limits. Adjust the alarm volume. Adjust the pulse beep volume. 4-2 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 B a s i c o p e r a t i o n c o n t i n u e d 15. Verify the sensor is applied correctly and that the measured data is appropriate, see Section 4, Successful Monitoring. 16. Monitor the patient. 17. After monitoring is complete, remove the sensor from the patient and store or dispose of the sensor according to local laws. See the Directions for Use of the sensor. 18. Press and hold the Power Button for 2 seconds to turn the Rad-87 off [3 seconds in the Home Mode]. DEFAULT SETTINGS The Rad-87 Pulse CO-Oximeter stores two types of default values that the device automatically retains after a power cycle. 1. Factory defaults set by Masimo. 2. Default settings that can be changed by the user which will be remembered after a power cycle. FACTORY DEFAULT AND USER CONFIGURABLE SETTINGS OPTION SpO2 high alarm limit SpO2 low alarm limit Pulse rate high alarm limit Pulse rate low alarm limit SpCO high alarm limit SpCO low alarm limit SpMet high alarm limit SpMet low alarm limit SpHb high alarm limit SpHb low alarm limit PI high alarm limit PI low alarm limit PVI high alarm limit PVI low alarm limit FACTORY DEFAULTS
"---" Off 90%
140 BPM 50 BPM 10
"---" Off 3 Off 16 7
"---" Off
"---" Off
"---" Off
"---" Off Sensitivity APOD Display brightness Pulse tone volume Alarm Silence Time Alarm Volume Monitoring Mode Audible Alarm Off Alarm Delay Rapid Desat Alarm Serial out Interface Alarm Level 2 Level 2 120 seconds Level 3, 70 db min Standard (Normal) Alarms active (On) 5 sec 5%
ASCII 2 Alarm On USER CONFIGURABLE DEFAULTS 2 to 99%
1 to 98%
35 to 235 BPM 30 to 230 BPM 2 to 98, then "---"
"---", then 1 to 97 1 to 99.5, then "---"
"---", then .1 to 99 2 to 24.5, then "---"
"---", then 1 to 24 0.04 to 19, then "---"
"---", then 0.03 to 18 2 to 99, then "---"
"---", then 1 to 98 Max/Normal/APOD NOTE: MAX sensitivity will default to APOD after a power cycle. Levels 1 thru 4 Off, Levels 1 thru 3 30, 60, 90, or 120 seconds Levels 1 thru 4, 87 db max Standard, Sleep, Home
"On/Off or muted with reminder"
0, 5, 10, or 15 seconds 5, 10, Off Philips/ASCII 1/ASCII 2 Alarm, Off/On Rad-87 Pulse CO-Oximeter Operators Manual 4-3 4 o p e r a t i o n FACTORY DEFAULT AND USER CONFIGURABLE SETTINGS (CONTINUED) Nurse Call Type Nurse Call Polarity Line Frequency Averaging time SmartTone FastSat Alarm Normal 60 Hz 8 sec Off Off Alarm and Low Signal IQ/
Low Signal IQ/
Alarm Normal/Invert 60 Hz, 50 Hz 2, 4, 8, 10, 12, 14, 16 On/Off Setting is retained after power cycle. Device Profile settings N/A Light blue, purple, pink, orange or green LCD Language English English (Default) French, German, Italian, Spanish, Swedish, Dutch, Danish, Portuguese On PVI Bar On/Off S u c c e s s f u l M o n i t o r i n g The following general points will aid in ensuring monitoring success. NOTE: See Safety Information, Warnings, Cautions and Notes for additional information. Place the sensor on a site that has sufficient perfusion and provides proper alignment of the LEDs and detector. Place the sensor on a site that has unrestricted blood flow. Do not secure a sensor with tape. Do not select a site near potential electrical interference (electro-surgical device, for example). Read the sensor Directions for Use for proper sensor application. MASIMO PULSE CO-OXIMETRY SENSORS Before use, carefully read the Masimo sensor Directions for Use. Use only Masimo sensors for pulse oximetry or pulse CO-Oximetry measurements. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor. CAUTIONS DO NOT USE DAMAGED SENSORS. DO NOT USE A SENSOR WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS. DO NOT 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 IN THE SENSOR DIRECTIONS FOR USE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR ALL MASIMO REUSABLE SENSORS. 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, RECONDITION OR RECYCLE MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM. 4-4 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 Low arterial perfusion. NUMERIC DISPLAY - SpO2 Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide confidence in changes that are artifactual or physiological and the speed, timing, and behavior of each. The stability of the readings over time is affected by the averaging mode being used. The longer the averaging time, the more stable the readings tend to become. This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times. However, longer averaging times delay the response of the device and reduce the measured variations of SpO2 Inaccurate measurements may be caused by:
Elevated levels of Carboxyhemoglobin. Elevated levels of Methemoglobin. Severe anemia. Elevated Total Bilirubin levels. Motion artifact. NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Rad-87 Pulse CO-Oximeter may differ slightly from the heart rate displayed on ECG monitors due to differences 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 quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed on the Rad-87 to be significantly different than the ECG heart rate. NUMERIC DISPLAY - SpCO A stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patients measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the arterial oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by:
Elevated levels of methemoglobin. Abnormal hemoglobin levels. Elevated Total Bilirubin levels. Motion artifact. Low arterial perfusion. Low arterial oxygen saturation levels. Intravascular dyes such as indocyanine green or methylene blue. NUMERIC DISPLAY - SpMet A stable SpMet reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patients measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the arterial oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by:
Elevated Total Bilirubin levels. Motion artifact. Intravascular dyes such as indocyanine green or methylene blue. Low arterial perfusion. Low arterial oxygen saturation levels. Rad-87 Pulse CO-Oximeter Operators Manual 4-5 4 o p e r a t i o n NUMERIC DISPLAY - SpHb A stable SpHb 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 the measurement site are mainly caused by fluctuations in the arterial oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by:
Elevated Total Bilirubin levels. Motion artifact. Intravascular dyes such as indocyanine green or methylene blue. Low arterial perfusion. Low arterial oxygen saturation levels. NUMERIC DISPLAY - SpOC A stable SpOC reading is associated with stable readings for both SpO2 and SpHb which comes with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by:
Elevated Total Bilirubin levels. Motion artifact. Elevated levels of carboxyhemoglobin. Elevated levels of methemoglobin. Severe anemia may cause erroneous SpOC readings. Intravascular dyes such as indocyanine green or methylene blue. Low arterial perfusion. Low arterial oxygen saturation levels. NUMERIC DISPLAY - (PI) The perfusion index (PI) display and bar graph indicator provide a relative numeric indication of the pulse strength at the monitoring site. It is a calculated percentage between the pulsatile signal and non-pulsatile signal of arterial blood moving through the site. PI may be used to find the best perfused site and to monitor physiological changes in the patient. It displays an operating range of 0.02 percent to 20.00 percent. A percentage greater than 1.00 percent is desired. Extreme changes in the display number are due to motion artifact and changes in physiology and blood flow. PLETH VARIABILITY INDEX - (PVI) The pleth variability index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percentage (0-100%). The PVI bar graph is a representation of the calculated value. 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 numeric measurement. 4-6 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 LOW PERFUSION The Rad-87 indicates perfusion on a 10-bar LED indicator. The lower two segments of the bar will turn red when the amplitude of the arterial pulsations is very low (low perfusion). It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation3. This localized hypoxemia may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that correlates with the ECG heart rate.) CAUTION: IF THE LOW PERFUSION MESSAGE IS FREQUENTLY DISPLAYED, FIND A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS. 3 Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension and Vasoconstriction. Anesthesiology 1990; 73:532-537 SIGNAL IQ - (SIQ) The Rad-87 Pulse CO-Oximeter display provides a visual indicator of signal quality and an alert when the displayed SpO2 values are not based on adequate signal quality. The signal quality indicator displayed on the Rad-87 is called the Signal IQ. The Signal IQ can be used to identify the occurrence of a patients pulse and the associated signal quality of the measurement. The Signal IQ is represented as a bar indicator where the height of the bar coincides with the strength of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Rad-87 locates the arterial pulsation. The pulse tone (when enabled) coincides with the rise of the Signal IQ Index. The height of the Signal IQ Index indicates the quality of the measured signal. A high Signal IQ Index indicates that the SpO2 measurement is based on a good quality signal. A small Signal IQ Index indicates that the SpO2 measurement is based on data with low signal quality. When the signal quality is very low the accuracy of the SpO2 measurement may be compromised. When the Signal IQ is low and the bar turns red, 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-87 to maintain accurate readings. Also, misalignment of the sensors emitter and detector can result in smaller signals. Determine if an extreme change in the patients physiology and blood flow at the monitoring site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion, sampling of an arterial blood specimen from the hand containing the pulse oximetry sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia, medications, or an episode of Raynauds syndrome). With neonates or infants, check that the peripheral blood flow to the sensor site is not interrupted. Interruption, for example, may occur while lifting or crossing their legs, during a diaper change. After performing the above, if the Low Signal IQ message is displayed frequently or continuously obtaining an arterial blood specimen for CO-Oximetry analysis may be considered to verify the arterial oxygen saturation value. Rad-87 Pulse CO-Oximeter Operators Manual 4-7 4 o p e r a t i o n SENSOR PLACEMENT If the SpO2, SpCO, SpMet or SpHb readings are questionable or unavailable, do the following:
Make sure the emitter and detector are aligned directly opposite each other. Select a site where the distance between the emitter and detector is minimized. Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl salicylate and 2-10% menthol) for 20-30 seconds to increase perfusion. However, strong vasodilator creams, such as nitroglycerin paste, are not recommended. If possible, remove electrical noise sources such as electro-surgical devices or other electrical/
electronic equipment. If these solutions are 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 remove the polish/
artificial nails. If possible, ensure that the sensor is placed in a location with low ambient light. Although the Rad-87 with integrated Masimo Rainbow SET technology has significant immunity to ambient light, excessive ambient light may cause readings to be incorrect. CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENTS VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE CO-OXIMETER FOR PROPER FUNCTIONING. SENSITIVITY The Rad-87 Pulse CO-Oximeter is equipped with 3 different sensitivity modes. Each mode allows the clinician to change the sensitivity settings of the device to meet the increased demands of the patients physiological condition or enable it to work during periods of low perfusion and/or motion. They are as follows:
Normal Sensitivity (NORM) This is the recommended mode for patients that are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as an intensive care unit (ICU). Adaptive Probe Off Detection (APOD) This is the recommended start-up monitoring mode for most patients with acceptable perfusion or where a more robust sensor off detection is desired. It is the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient. Maximum Sensitivity (MAX) - This mode is recommended for patients with low perfusion or when the low perfusion or low signal quality message is 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 display data at the measuring site when the signal may be weak due to decreased perfusion. When a sensor becomes detached from a patient, it will have compromised protection against erroneous pulse rate and arterial saturation readings. Also, after a power off and on cycle, the sensitivity will change from the MAX to the factory default or user configured default setting of APOD or NORM. CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING, THE PERFORMANCE OF THE SENSOR OFF DETECTION MAY BE COMPROMISED. IF THE DEVICE IS IN THIS SETTING AND THE SENSOR BECOMES DISLODGED FROM THE PATIENT, THE POTENTIAL FOR FALSE READINGS MAY OCCUR DUE TO ENVIRONMENTAL NOISE SUCH AS LIGHT, VIBRATION AND EXCESSIVE AIR MOVEMENT. 4-8 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 LOW BATTERY AUDIBLE ALARM If a low battery condition occurs the audible alarm can be silenced until power cycle by pressing the Alarm Silence Button. Refer to Setup Menu Level 2 in this section to change setting. If a low battery condition occurs while not monitoring a patient, a low priority audible alarm will sound and can be silenced by pressing the Alarm Silence Button. The audible alarm is silenced until the power is cycled or patient monitoring begins. While audible alarms are silenced, the first Battery Level Indicator bar to the left flashes green, and the System Status Light flashes yellow to provide a visual alert for the user. When a low battery condition occurs, immediately discontinue patient monitoring and plug the Rad-87 into AC power. The AC Power Indicator on the Rad-87 illuminates and remains illuminated while the battery is charging, however, the Battery Charge Level Indicator does not illuminate. Once the battery is fully charged all Battery Charge Level Indicators illuminate green when unplugged. During normal patient monitoring, the Battery Charge Bars (Battery Charge Level Indicator) illuminate green from left to right to indicate the approximate amount of battery charge when unplugged. CAUTION:
CAUTION: THE BATTERY SHOULD BE ADEQUATELY CHARGED TO ENSURE BACKUP THE BATTERY SHOULD BE ADEQUATELY CHARGED TO ENSURE BACKUP POWER IN CASE OF AC POWER DISRUPTION. POWER IN CASE OF AC POWER DISRUPTION. N o r m a l p a t i e n t m o n i t o r i n g When all optional parameters/measurements are installed and during normal operation, the Rad-87 display shows Screen 1 containing arterial oxygen saturation (%SpO2) and pulse rate in beats per minute (BPM) and total hemoglobin (SpHb g/dl)*. By pressing the Display Button once, the display changes to show Screen 2 containing total arterial oxygen content (SpOC ml/dl)* perfusion index
(PI) and pleth variability index (PVI)*. Pressing the Display Button again changes the 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 parameters/measurements: SpCO, SpMet, SpHb, SPOC, PVI Display Screens showing Parameters/Measurements -Default Locations
. 76 10.1 Screen 1 Home display screen 1.60 20 13 3 PVI Screen 2 Screen 3 Rad-87 Pulse CO-Oximeter Operators Manual 4-9 4 o p e r a t i o n Normal patient monitoring continued If SpMet and SpCO are/or not installed, the display will only move from Screen 1 to Screen 3 when the Display Button is pressed; Screen 2 will not show. By pressing the Display Button again, the display will move from Screen 3 to Screen 1. Display Screens with All Parameters and Measurements 76 10.1 Screen 1 Home display screen 13 10.1 Screen 2 Display Screens when SpMet, SpCO and PVI Are Not Installed 1.60
%SpCO 20 3 Screen 3 76 10.1 13 No Screen 3 Screen 1 Home display screen Screen 2 Display Screens with SpHb and PVI Installed and SpMet and SpCO Not Installed 76 10.1 Screen 1 Home display screen 13 3 Screen 2 No Screen 3 4-10 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 PARAMETER/MEASUREMENT SELECTION The bottom eld of any display screen may be con gured to show SpHb or PVI (see Parameter Select menus). Once SpHb or PVI is con gured to show on a screen different from the default location, the alarm limit menu for SpHb or PVI can be accessed from the new screen by pressing the Alarm Limits Button. Display Screens Showing PVI on Screen 1 76 3 Screen 1 Home display screen 13 10.1 Screen 2 Display Screens Showing SpHb on Screen 1 and 2 76 10.1 Screen 1 Home display screen 13 10.1 Screen 2 1.60 20 Screen 3 1.60
%SpCO 20 3 Screen 3 Rad-87 Pulse CO-Oximeter Operators Manual 4-11 4 o p e r a t i o n SETUP MENU This section gives an overview of the Rad-87 menu selections available. To access the menu levels and navigate through the menu selections, use the front panel buttons, Enter Button and Up/Down Buttons as indicated in the following sections. Sub-sections describe each menu item in more detail. The Rad-87 has options that allow user configuration to accommodate specific needs. MENU NAVIGATION The Rad-87 set-up and configuration options are accessed through the menu system. Three 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 repeated cycling through the options. The Up and Down Buttons are used to adjust values within each option. The parameter/measurement value is set when the Enter Button is pressed. Pressing the Display Button exits the menus and returns the device to Screen 1. When accessing the Rad-87 menu, each selection will be communicated visually on the LED (front of device) and LCD (top of device) displays, simultaneously. NOTE: The Rad-87 will automatically time out of the setup menu after 10 seconds with no button presses. SETUP MENU LEVEL 1 Setup Menu Level 1 contains the parameters/measurements and settings that are adjusted most often for patient monitoring; alarm limits, display brightness, and sensitivity settings. Pressing the Display Button while viewing alarm limit settings allows the user to exit the Setup Menu and return to Screen 1. 4-12 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 SETUP MENU LEVEL 1 (CONTINUED) PARAMETER/MEASUREMENT ALARM LIMITS - SCREEN 1 To access alarm limits for parameters/measurements contained on Screen 1, press the Alarm Limits Button to access the Alarm Limits menu for Screen 1 parameters/measurements. BUTTONS SETTINGS Press once Use the Alarm Limits Button to access the alarm limits options and move between options.
%SpO2 LO
%SpO2 HI Pulse rate (BPM) LO Pulse rate (BPM) HI SpHb g/dl LO SpHb g/dl HI Press 2x Press 3x Press 4x Press 5x Press 6x Use Up or Down Buttons to adjust the value to the desired setting AND press the Alarm Limits Button or Enter Button to accept the setting and move to the next option. Once the last option is accessed an additional press of the Alarm Limits Button or Enter Button will return the device to Screen 1. OR press the Display Button to exit at any time and return to Screen 1. NOTE: User default settings can be changed for specific patient environments. Rad-87 Pulse CO-Oximeter Operators Manual 4-13 4 o p e r a t i o n SETUP MENU LEVEL 1 (CONTINUED) PARAMETER/MEASUREMENT ALARM LIMITS - SCREEN 2 To access alarm limits for parameters/measurements contained on Screen 2, press the Display Button to move from Screen 1 to Screen 2. From Screen 2, press the Alarm Limits Button to access the Alarm Limits menu for Screen 2 parameters/measurements. BUTTONS SETTINGS Press once Use the Alarm Limits Button to access the alarm limits options and move between options. Press 2x Press 3x Press 4x PI LO PI HI PVI LO PVI HI Use Up or Down Buttons to adjust the value to the desired setting AND press the Alarm Limits Button or Enter Button to accept the setting and 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 2. OR press the Display Button to exit at any time and return to Screen 2. NOTE: User default settings can be changed for specific patient environments. 4-14 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 PARAMETER/MEASUREMENT ALARM LIMITS - SCREEN 3 To access alarm limits for parameters/measurements contained on Screen 3, press the Display Button two times to move from Screen 1 to Screen 3. Press the Alarm Limits Button from Screen 3 to access the Alarm Limits menu for Screen 3 parameters/measurements. BUTTONS SETTINGS Press once Use the Alarm Limits Button to access the alarm limits options and move between options. Press 2x Press 3x Press 4x
%SpMet LO Use Up or Down Buttons to adjust the value to the desired setting AND press the Alarm Limits Button or Enter Button to accept the setting and move to the next option. Once the High Pulse rate limit is accessed an additional press of the Alarm Limits Button or Enter Button will return the device to Screen 3. OR press the Display Button to exit at any time and return to Screen 3.
%SpMet HI
%SpCO LO
%SpCO HI NOTE: User default settings can be changed for specific patient environments. LED BRIGHTNESS The Display screen and all active LED indicators are effected while adjusting this setting. BUTTONS SETTINGS Press once Use the Brightness Button to access the LED brightness options and move between options. Press 2x Press 3x Press 4x Default Level 2 Level 3 Level 4 Level 1 Use the Brightness Button to move between menu options and the Enter Button to accept the setting and return to the home display screen. NOTE: User default settings can be changed for specific patient environments. Rad-87 Pulse CO-Oximeter Operators Manual 4-15 4 o p e r a t i o n SETUP MENU LEVEL 1 (CONTINUED) SENSITIVITY BUTTONS SETTING Press once Use the Sensitivity Button to access the sensitivity options and move between options. Press 2x Default APOD NORM Use the Sensitivity Button to move between menu options and accept the setting. Press 3x MAX
(The MAX Indicator flashes in this mode.) SETUP MENU LEVEL 2 Level 2 menu contains parameters and settings that are not changed as frequently as Level 1. These include alarm volume, alarm silence, alarm delay, clear trend and button volume parameters. ALARM VOLUME BUTTONS SETTINGS Use the Enter Button to access the Alarm Volume menu and to move between Level 2 menus. Default Level 3 Level 4 Level 1 Level 2 Use Up or 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 the home display screen. 4-16 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n SETUP MENU LEVEL 2 (CONTINUED) ALARM SILENCE BUTTONS SETTINGS 4 Press the Enter Button again to move to the next menu. 2x Default 120 seconds 90 seconds 60 seconds 30 seconds Use Up or 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 the home display screen. ALARM DELAY Alarm delay allows the user to adjust the time in which the audible status indicator will occur after an alarm condition has been initiated. BUTTONS SETTINGS Press the Enter Button again to move to the next menu. 3x Default 5 seconds 0 seconds 15 seconds 10 seconds Use Up or 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 the home display screen. Rad-87 Pulse CO-Oximeter Operators Manual 4-17 4 o p e r a t i o n SETUP MENU LEVEL 2 (CONTINUED) CLEAR TREND The Rad-87 only stores data in the trend memory while the device is turned on. Trend data saves to the memory until the memory is full or cleared by the user. NOTE: It is recommended that you clear the trend prior to performing a new patient data collection procedure. BUTTON SETTING Press the Enter Button again to move to the next menu. 4x BUTTON VOLUME BUTTON SETTING Press the Enter Button again to move to the next menu. 5x Default NO Use Up or Down Button to move between settings and the Enter Button to accept the setting and move to the next menu screen. OR YES
(Clear trend) press the Display Button to exit without saving the new setting and to return to the home display screen. Default Level 2 Level 1 Off Level 3 Use Up or 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 the home display screen. FASTSAT FastSat enables rapid tracking of arterial oxygen saturation 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 saturation values providing an averaged saturation value that is a better representation of the patients current oxygenation status. With FastSat, the averaging time is dependent on the input signal. 4-18 Rad-87 Pulse CO-Oximeter Operators Manual 4 o p e r a t i o n SETUP MENU LEVEL 2 (CONTINUED) FASTSAT BUTTON SETTING Press the Enter Button again to move to the next menu. 6x Default Off On Use Up or Down Button to move between settings and the Enter Button to accept the setting and move to the Alarm Volume menu. OR press the Display Button to exit without saving the new setting and to return to the home display screen. T r e n d s e t u p a n d u s e INTRODUCTION The Rad-87 can store up to 72 hours of trend data captured at 2 second intervals. The trend data can then be transferred to a PC for evaluation. A serial cable is required to connect the Rad-87 to a PC. Patient monitoring is not possible while trend memory is being transferred to a PC. Trend data is stored in non-volatile memory, so it is not erased when the device is shut off. A trend data download is initiated using the TrendCom utility which downloads the trend data and saves it to an ASCII text (.out) file with an output delimiter option. NOTE: Rad-87 Serial Ouput must be set to ASCII 2 for successful download of trending data. Refer to the Serial Output menu and settings located farther in this chapter. TRENDCOM UTILITY INSTALLATION Copy the TrendCom utility from the TrendCom CD onto a PC running MS-Windows. TRENDCOM UTILITY OPERATION 1. Turn Rad-87 off if not already off. 2. Connect serial cable to Rad-87 and other end to a com port on the PC. 3. 4. 5. 6. 7. 8. Turn the Rad-87 on. Start the TrendCom utility on the PC. Select Rad-87 from the first pull-down menu. Select the appropriate com port number from the second pull-down menu, if necessary. Select the Output Delimiter Option (Tab, Comma or Space). Select the RETRIEVE TREND button on the TrendCom utility. Select the desired location and assign a file name for the trend file. Select SAVE. Rad-87 Pulse CO-Oximeter Operators Manual 4-19 4 o p e r a t i o n T r e n d s e t u p a n d u s e c o n t i n u e d 9. The Rad-87 will display dat out while trend data is being transferred. A progress bar will advance to indicate the status of the download. Larger trend files will take longer to download. Transfer time is approximately 20 seconds per hour of trend data. NOTE: During download of trend information, all normal Rad-87 functions are unavailable and the keypad is locked, except for the power button. 10 When trend data transfer is complete, close TrendCom and disconnect the Rad-87 from the serial cable. 11. Turn the Rad-87 off to exit the trend download mode. NOTE: Contact USB to serial port adapter manufacturer for assistance or support. ERASING TREND MEMORY To erase (clear) the trend memory, set the Clear Trend option to Yes and press the Enter Button to accept the setting and clear the data from the memory. Refer to the Clear Trend menu located before this Trend setup and use section. The Rad-87 continuously trends data. When performing a new study and gathering data on a new patient, it is highly recommended the "clear function" be utilized in order for the results to be separate. Turning the Rad-87 off will not erase the trend data. TREND DATA FORMAT After a successful download of the trend data, a .out file will be created containing the trend-dump information in ASCII delimited format. The format is defined in the following table. 4-20 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n TREND DATA FORMAT (CONTINUED) 4 PARAMETER Date Time Installed Parameter/
Measurement Exception Messages SPECIFICATION MM\DD\YY HH:MM:SS Numeric value (see the display ranges in the Factory and User Configurable Default Settings table located at the beginning of this section) The exceptions are displayed as a 3 digit, ASCII encoded, hexadecimal value. The binary bits of the hexadecimal value are encoded 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 SET sensor and needs to acquire some clean data for this flag to be set SAMPLE TREND OUTPUT 07/21/08 09:56:08 SpO2=000 PR=000 PI=00.00 EXC=820:OffPat,SET 07/21/08 09:56:10 SpO2=000 PR=000 PI=00.00 EXC=828:Search,OffPat,SET 07/21/08 09:56:12 SpO2=097 PR=069 PI=04.69 EXC=800:SET 07/21/08 09:56:14 SpO2=096 PR=074 PI=02.28 EXC=C00:LowSigIQ,SET 07/21/08 09:56:16 SpO2=098 PR=078 PI=03.64 EXC=800:SET 07/21/08 09:56:18 SpO2=000 PR=000 PI=00.00 EXC=800:SET 07/21/08 09:56:20 SpO2=000 PR=000 PI=00.00 EXC=820:OffPat,SET 07/21/08 09:56:22 SpO2=096 PR=078 PI=02.68 EXC=800:SET Rad-87 Pulse CO-Oximeter Operators Manual 4-21 4 o p e r a t i o n SETUP MENU LEVEL 3 ENTER BUTTON + DOWN BUTTON MENU SETTINGS The Level 3 menu contains advanced parameter/measurement settings. To access Level 3 parameters/measurements, hold down the Enter Button and press the Down Button for 5 seconds. After entering menu Level 3, use the Enter Button to save new settings and move to the next menu. The user may cycle through the 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 Button and press the Down Button for 5 seconds.
Default 8 seconds 4 seconds 2 seconds 16 seconds 14 seconds 12 seconds 10 seconds
(The cycling function for the menu options is not available.) 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 and to return to the home display screen. 4-22 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) 4 RAPID DESAT LIMIT The Rapid Desat Limit is designed to detect rapid desaturations of 5% or 10% below the low alarm limit and overrides the Alarm Delay feature when activated. BUTTONS SETTING Press the Enter Button again to move to the next menu. ALARM ON/OFF BUTTONS SETTING Press the Enter Button again to move to the next menu. Default 5%
Off 10%
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 settings and to return to the home display screen. Default On Off 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 Off rE
(Alarm off with reminder.) press the Display Button to exit without saving the new setting and to return to the home display screen.
*When Alarm On/Off is set to "Off rE", the audible alarm "beeps" twice every three minutes to remind the user that the Rad-87 is currently in alarm status but the audible alarm is muted. Visual alarms are active in this mode. If an alarm limit is violated, the associated parameter/
measurement label and value flash, the alarm bell flashes red for high priority alarms and the System Status Light is solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. Rad-87 Pulse CO-Oximeter Operators Manual 4-23 4 o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) DEFAULT SETTINGS BUTTONS SETTING Press the Enter Button again to move to the next menu. No change
(Do not adjust factory default settings.) User Default
(Set to user settings.*) Factory Default
(Restore factory default settings.) Set Device Profile
(One or more pre-defined device profiles) 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 return to the home display screen.
*Set the Factory Default to this setting when con guring a Device Pro le. Refer to the Device Pro le Setup and Use section of this chapter for additional information and instructions. 4-24 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 D e v i c e P r o f i l e S e t u p a n d U s e The Rad-87 can be configured to save changes to the device settings as a Device Profile. Using the Rad-87 button menu or an external configuration application, users can adjust Rad-87 settings and parameter/measurement alarm limits. After changing settings, the user may save the settings as a Device Profile. This Device Profile becomes the new default settings and the saved (Device Profile) settings will be retained after a power cycle. 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 the same time for 5 seconds. Then, by pressing the Enter Button three times, the Default Settings screen is displayed. Press the Up or Down Arrow Button until User Default Set is displayed on the LCD. The user can press the Enter Button again to save the settings. Using an external configuration application, the user can save up to five profiles. The user may select a color for the Device Profile LED to associate with the saved profiles. The Device Profile LED (located on the front panel of the Rad-87 above the sensor connector) will illuminate with the selected color, allowing the user to verify at a glance that a Device Profile has been set on the Rad-87. If changes are made to the device settings after the Device Profile feature has been enabled, the Device Profile LED will turn off until the device is returned to the user configured default settings or powered off, indicating a change from the Device Profile settings. To set a device profile, the user enters Menu Level 3 by pressing and holding the Enter Button and Down Arrow Button at the same time for 5 seconds. Then, by pressing the Enter Button three times, the Default Setting screen is displayed. The user can use the Up or Down Arrow Button to select the desired profile and press the Enter Button to save the setting. Rad-87 Pulse CO-Oximeter Operators Manual 4-25 4 o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) PVI BAR ON/OFF (IF AVAILABLE) BUTTONS SETTING Press the Enter Button again to move to the next menu. Default On Off
(No PVI Bar or parameter/
measurement label displayed) 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 return to the home display screen. SMART TONE ON/OFF 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 there is excessive artifact present. The Normal Tone feature uses a proprietary algorithm that will provide pulse tones during non motion and adequate perfusion conditions. In this mode, the pulse tone may not sound if excessive artifact is present. BUTTONS SETTING Press the Enter Button again to move to the next menu. YEAR BUTTONS SETTING Press the Enter Button again to move to the next menu. Default Off
(Normal Tone) 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 On
(Smart Tone) press the Display Button to exit without saving the new setting and to return to the home display screen. Default year Use Up or Down Button to adjust the setting. 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 return to the home display screen. 4-26 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) MONTH BUTTONS SETTING 4 Press the Enter Button again to move to the next menu DAY BUTTONS SETTING Press the Enter Button again to move to the next menu. HOUR BUTTONS SETTING Press the Enter Button again to move to the next menu. Default Month Use Up or Down Button to adjust the setting. 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 return to the home display screen. Default days Use Up or Down Button to adjust the setting. 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 return to the home display screen. Default hour Use Up or Down Button to adjust the setting. 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 return to the home display screen. Rad-87 Pulse CO-Oximeter Operators Manual 4-27 4 o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) MINUTE BUTTONS SETTING Press the Enter Button again to move to the next menu. Default 30 minutes Use Up or Down Button to adjust the setting. 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 return to the home display screen. SOFTWARE VERSION BUTTONS SETTING Press the Enter Button again to move to the next menu Displays software version. SERIAL OUTPUT BUTTONS SETTING Press the Enter Button again to move to the next menu. Default AS2 (ASCII 2) Use Up or Down Button to move between settings AND AS1 (ASCII 1) press the Enter Button to accept the setting and move to the next menu. OR PHL
(Philips Vuelink) press the Display Button to exit without saving the new setting and to return to the home display screen. 4-28 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) 4 INTERFACE ALARMS When Rad-87 is interfaced to another system and the Interface Alarms are set to "Off", SpO2 and BPM audible alarms are 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 power interruptions or when the interface connection is lost. This ensures that the Rad-87 provides SpO2 and BPM audible alarms when connection to the interfaced system becomes compromised. BUTTONS SETTING Press the Enter Button again to move to the next menu. Default On NOTE: LCD shows SpO2 and BPM alarms On. Off (only SpO2/BPM) NOTE: LCD shows SpO2 and BPM alarms Off. 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 return to the home display screen. S y s t e m i n t e r f a c e s PHILIPS VUELINK SETUP 1. Select the Philips VueLink selection from the Serial Output menu on the Rad-87. After selecting, choose the preferred settings by stepping through menu options. 2. Connect one end of the VueLink cable to the Serial Output connector on the back of the Rad-87. 3. Connect the other end of the VueLink cable to the VueLink module and insert the module into the Philips/Agilent monitor rack. 4. The SpO2 and pulse rate values will automatically appear on the HP/Agilent monitor. 5. In order for the pleth waveform to be displayed on the Philips/Agilent monitor and for the Philips/
Agilent monitor to indicate the alarm conditions measured by the pulse oximeter, the user must configure the Philips/Agilent monitor. Please see the Philips/Agilent Operators manual for complete instructions. 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 and disable audible alarms on the Rad-87. 6. Rad-87 Pulse CO-Oximeter Operators Manual 4-29 4 o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) RADNET SETUP 1. Connect one end of the serial cable to the Serial Output connector on the back of the Rad-87. Turn the RadNet Interface Module on. Select the ASCII 2 selection from the Serial options on the Rad-87. A proper connection is shown by the RadNet Interface Module's Online LED being solid. 2. Connect the other end of the serial cable to the RadNet Interface Module connector. 3. 4. 5. 6. With a properly configured RadNet Interface Module, the Rad-87 will automatically display the SpO2, PVI, PI and Pulse Rate parameters/measurements on the screen at the RadNet Central Station. The Rad-87 Pulse CO-Oximeter can be set up to audibly indicate all patient alarms while communicating with the RadNet Interface module. 7. PATIENT SAFETYNET SETUP 1. 2. Contact Masimo installation personnel for proper installation guidance. Select the ASCII 2 selection from the Serial options on the Rad-87. 4-30 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) NURSE CALL*
BUTTONS SETTING 4 Press the Enter Button again to move to the next menu option. Default Alarm Signal IQ 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 Alarm and Signal IQ press the Display Button to exit without saving the new setting and to return to the home display screen.
*Refer to Section 7, Nurse call speci cations for additional information. POLARITY*
BUTTONS SETTING Press the Enter Button again to move to the next menu option. Default Normal Inverse 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 and to return to the home display screen.
*Refer to Section 7, Nurse call speci cations for additional information. LINE FREQUENCY BUTTONS SETTING Press the Enter Button again to move to the next menu option. Default 60 50 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 and to return to the home display screen. Rad-87 Pulse CO-Oximeter Operators Manual 4-31 4 o p e r a t i o n SETUP MENU LEVEL 3 (CONTINUED) PARAMETER/MEASUREMENT SELECT - SCREEN 1 BUTTONS SETTING Press the Enter Button again to move to the next menu option. SpHb
(if available) PVI
(if available)
(no parameter/
measurement displayed) 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 and to return to the home display screen. PARAMETER/MEASUREMENT SELECT - SCREEN 2 BUTTONS SETTING Press the Enter Button again to move to the next menu option. SpHb
(if available) PVI
(if available)
(no parameter/
measurement displayed) 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 and to return to the home display screen. 4-32 Rad-87 Pulse CO-Oximeter Operators Manual o p e r a t i o n 4 SETUP MENU LEVEL 3 (CONTINUED) PARAMETER/MEASUREMENT SELECT - SCREEN 3 BUTTONS SETTING Press the Enter Button again to move to the next menu option. LCD LANGUAGE BUTTONS SETTING Press the Enter Button again to move to the next menu option. SpHb
(if available) PVI
(if available) 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
(no parameter/
measurement displayed) press the Display Button to exit without saving the new setting and to return to the home display screen. Default English Use Up or Down Button to move between settings AND Scrolls through available languages displayed on the LCD 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 and to return to the home display screen. ENTER BUTTON + UP BUTTON MENU SETTING SET MODE BUTTONS SETTING 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 Sleep Mode*
Home Mode press the Enter Button to accept the setting. OR press the Display Button to exit without saving the new setting and to return to the home display screen.
*CAUTION: ALARMS ARE DISABLED IN THIS MODE. Rad-87 Pulse CO-Oximeter Operators Manual 4-33 4 o p e r a t i o n H O M E M O D E O P E R A T I O N The Rad-87 can be placed into the Home Mode to protect unqualified users from changing the Rad-87 alarm settings and operation. Only the following menu and front panel functions are available: display brightness, pulse beep volume adjustment and alarm silence. Alarm volume is at highest setting. All default and user defined default settings are locked to their current values when home mode is selected and return to those values after a power cycle. Upon power up, the Hnn mode will be displayed along with a 10 second display of parameters/measurements. To turn the device off the Power Button must be depressed 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 into the Sleep Mode to allow the device to capture normal and abnormal patient data without triggering the alarms. This mode will blank out the LED and the LCD Displays with the exception of the AC Power Indicator, the System Status Light, and the Battery Level Indicator and disables the alarms even after a power cycle. However, pressing any button illuminates the display and the System Status Light (solid yellow) for 10 seconds. Upon power up, the SLP mode will be displayed along with a 10 second display of parameterr/measurement settings. The Enter and Up Buttons held simultaneously for 5 seconds will put it back into the special menu to select a different mode. CAUTION: ALARMS ARE DISABLED IN THIS MODE BRIGHTNESS BUTTON + DOWN BUTTON MENU SETTING Access the Enable/Disable Radio menu by holding down the Brightness Button and the Down Button for 5 seconds. ENABLE/DISABLE RADIO BUTTONS SETTING Hold down the Brightness Button and press the Down Button for 5 seconds.
Default Off On Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and exit to the home display screen. LCD DISPLAY FUNCTION WITH RADIO CONFIGURED AND ENABLED When the Radio feature is enabled (set to "On") and configured with the required network information, the LCD Display shows the following information for 20 seconds:
SSID Subnet Gateway MAC Address IP address 4-34 Rad-87 Pulse CO-Oximeter Operators Manual
1 2 | User Manual part 2 | Users Manual | 231.25 KiB |
g a l a r m s a n d m e s s a g e s 5 A l a r m i d e n t i f i c a t i o n The Rad-87 visually and audibly indicates alarm conditions that the system detects. Audible alarms may be silenced, without affecting the operation of visual alarms. Three levels of alarm priority are implemented: high, medium and low priority. The following table outlines the alarm priority specifications. PARAMETER/MEASUREMENT ALARM SETTING RANGE Low arterial oxygen saturation High carboxyhemoglobin saturation High methemoglobin saturation Low total hemoglobin concentration High total hemoglobin concentration High pulse rate Low pulse rate Sensor off and no sensor Defective Sensor Defective Patient Cable System failures High saturation Low PI High PI Low PVI High PVI Low battery, monitoring patient Low carboxyhemoglobin saturation High Medium Low Low methemoglobin saturation Low battery, not monitoring patient NOTE: There are no alarms associated with SpOC. Audible and visual Rad-87 Pulse CO-Oximeter Operators Manual 5-1 5 a l a r m s a n d m e s s a g e s A l a r m i n d i c a t i o n An alarm condition caused by an out-of-limit parameter/measurement is indicated by:
Audible alarm tone System Status Light flashes red for high priority alarms, flashes yellow for medium priority Flashing Out-of-limit parameter/measurement label and value alarms or shows solid yellow for low priority alarms Red flashing Alarm Bell for high priority alarms A l a r m l i m i t s CAUTION: TO ENSURE THAT ALARM LIMITS ARE APPROPRIATE FOR THE PATIENT BEING MONITORED, CHECK THE LIMITS EACH TIME THE RAD-87 IS USED. When an alarm limit is exceeded, an audible alarm activates and the Alarm Bell flashes red for high priority alarms and the System Status Light is solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. When a sensor is not connected to a patient, SEN OFF message will show on the display. When a sensor is not connected to its cable, NO SEN message will show on the display. 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: USER CONFIGURABLE SETTINGS SETTING SpO2 High Limit SpO2 Low Limit*
SpCO High Limit SpCO Low Limit*
SpMet High Limit SpMet Low Limit*
RANGE The SpO2 high alarm limit can be set anywhere between 2% and 99%, then "---"
(Off), with a 1% step size. In the ---- (Off) setting, the SpO2 High Limit alarm is disabled. The SpO2 low alarm limit can be set anywhere between 1% and 98%, with a 1%
step size. The SpCO high alarm limit can be set anywhere between 2% and 98%, then "---"
(Off), with a 1% step size. The SpCO low alarm limit can be set anywhere between "---" (Off), then 1% and 97%, with a 1% step size. In the ---- (Off) setting, the SpCO Low Limit alarm is disabled. The SpMet high alarm limit can be set anywhere between 1% and 99.5%, then "---"
(Off). Adjust in increments of 0.1% for values between 0.1% to 2%. Adjust in incre-
ments of 0.5% for values between 2% and 99.5%. The SpMet low alarm limit can be set anywhere between "---" (Off), then 0.1%
and 99%. Adjust in increments of 0.1% for values between 0.1% to 2%. Adjust in increments of 0.5% for values between 2% and 99.5%. When SpMet is placed in the ---- (Off) setting, the SpMet Low Limit alarm is disabled. 5-2 Rad-87 Pulse CO-Oximeter Operators Manual a l a r m s a n d m e s s a g e s 5 ALARM LIMIT: USER CONFIGURABLE SETTINGS (CONTINUED) SETTING SpHb High Limit RANGE The SpHb high alarm limit can be set anywhere between 2 g/dl and 24.5 g/dl, then ---- (Off). Adjust in increments of 0.1 g/dl step size between 2 g/dl and 20 g/dl and 0.5 g/dl step size between 20 g/dl and 24.5 g/dl. When SpHb is placed in the ---- (Off) setting, the SpHb High Limit alarm is disabled. SpHb Low Limit*
The SpHb low alarm limit can be set to "---" (Off), then anywhere between 1 g/dl and 24 g/dl. Adjust in increments of 0.1 g/dl step size between 0.1 g/dl and 20 g/
dl and 0.5 g/dl step size between 20 g/dl and 24 g/dl. When SpHb is placed in the
---- (Off) setting, the SpHb Low Limit alarm is disabled. The PI high alarm limit can be set anywhere between 0.04 % and 19%, then ----
(Off). Adjust in increments of 0.01% step size between 0.02% and 0.1%, 0.1%
step size between 0.1% and 1% and 1% step size between 1% and 19%. When PI is placed in the ---- (Off) setting, the PI High Limit alarm is disabled. The PI low alarm limit can be set anywhere between "---" (Off), then 0.03% and 18%. Adjust in increments of 0.01% step size between 0.03% and 0.1%, 0.1%
step size between 0.1% and 1% and a 1% step size between 1% and 18%. When PI is placed in the ---- (Off) setting, the PI Low Limit alarm is disabled. The PVI high alarm limit can be set anywhere between 2% and 99%, then ----
(Off). Adjust in increments of 1% step size. When PVI is placed in the ---- (Off) setting, the PVI High Limit alarm is disabled. 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 Low Limit alarm is disabled. The pulse rate high alarm limit can be set anywhere between 35 BPM and 235 BPM, with a 5 BPM step size. The pulse rate low alarm limit can be set anywhere between 30 BPM and 230 BPM, with a 5 BPM step size. PI High Limit PI Low Limit*
PVI High Limit PVI Low Limit*
Pulse Rate High Limit (BPM) Pulse Rate Low Limit (BPM)*
* The low alarm limit must always be set below the high alarm setting. Attempting to set the high alarm limit below the low alarm limit, the low alarm limit will automatically adjust the low limit to the next setting below the newly entered high alarm limit setting. NOTE: Pressing and holding down the up and down buttons allow for the rapid scrolling of changing alarm limits. NOTE: If there is a loss of power for any length of time, the Alarm settings will be set back to the User set defaults. If the user has not utilized this option, then all parameters/measurements will be set back to the factory defaults. Rad-87 Pulse CO-Oximeter Operators Manual 5-3 5 a l a r m s a n d m e s s a g e s SINGLE ALARM When an alarm is activated, the display shows the screen containing the parameter/measurement in alarm status. The number value and the label (name) for the parameter/measurement in alarm status flash, an audible alarm activates, the Alarm Bell flashes red for high priority alarms and the System Status Light is solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. MULTIPLE PARAMETER/MEASUREMENT ALARMS When multiple parameters/measurements alarm, the screen with the highest alarm priority (and with an parameter/measurement in alarm status) will show on the display. Refer to the table Alarm Priority for Display Screens located below. The number value and the label (name) for the parameter/measurement in alarm status flash, an audible alarm activates, the Alarm Bell flashes red for high priority alarms and the System Status Light 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 (competing alarms) that are not contained on the active screen will show as flashing parameter/measurement labels (names). The parameters/measurements with competing alarms can be viewed by pressing the Display Button to scroll through the screens. When an alarm is resolved, the parameter/measurement label stops flashing. When all parameters/
measurements in alarm status on a display screen are resolved, the screen changes to show the next priority screen with active alarms. ALARM PRIORITY FOR DISPLAY SCREENS PRIORITY DISPLAY SCREEN PARAMETERS/MEASUREMENTS SHOWN 1 2 3 Screen 1 Screen 2 Screen 3
%SpO2, BPM, SpHb g/dl PI, %SpCO ml/dl, PVI
%SpMet, %SpCO The display screens are assigned alarm priority according to the table above. Screen 1 has first priority and displays if it contains a parameter/measurement in alarm status with other competing parameter/measurement alarms. When Screen 2 contains the competing parameter/
measurement alarms, Screen 2 will take priority and show on the display. Screen 3 has the lowest priority. 5-4 Rad-87 Pulse CO-Oximeter Operators Manual a l a r m s a n d m e s s a g e s 5 ALARM SILENCE Audible alarms may be silenced, while visual alarms remain active. The alarm silence function is controlled by pressing the Alarm Silence Button. The Alarm Bell and the System Status Light provide visual feedback when the Rad-87 audible alarms are silenced. Alarm Silence function when monitoring a patient:
Power-On Alarms active, Alarm Bell flashes red for high priority alarms and the System Status Light is solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. Press Once Alarm suspended for 120 seconds, audible alarms are silenced. The Alarm Bell flashes red for high priority alarms and the System Status Light flashes yellow for all alarms. Press Twice Return to audible alarms active, audible alarms return. Repeated pressing of the Alarm 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 solid yellow. Press Once Device is silenced until it is cycled off/on or until monitoring begins. The Alarm Bell is not flashing and the System Status Light is solid yellow for low priority alarms. ALARM BELL The Alarm Bell flashes red for high priority alarms. Pressing the Alarm Silence Button once silences the audible alarm for 120 seconds (default) while the Alarm Bell flashes to indicate an alarm condition. If the high priority alarm condition is resolved during the Alarm silence interval, the Alarm Bell stops flashing. If the high priority alarm condition remains (Alarm Bell flashing red), pressing the Alarm Silence button again activates the audible alarms and the Alarm Bell continues to flash red. The Alarm Bell stops flashing when the high priority alarm conditions are resolved. Rad-87 Pulse CO-Oximeter Operators Manual 5-5 5 a l a r m s a n d m e s s a g e s SYSTEM STATUS LIGHT While monitoring a patient and an alarm condition occurs, an audible alarm activates and the System Status Light shows solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. Pressing the Alarm Silence Button (one time) silences the alarm tone for 120 seconds (default). Pressing the Alarm Silence Button a second time activates the audible alarms and the System Status Light shows solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. When all alarm conditions are resolved, the System Status Light changes to solid green. When monitoring a patient and there are no alarm conditions, the System Status light shows green. Pressing the Alarm Silence Button (one time) silences the alarm tone for 120 seconds and the System Status Light flashes yellow if there is not alarm condition. Pressing the Alarm Silence Button a second time returns the device to normal monitoring status and the System Status Light illuminates green when patient monitoring begins. 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 Silence Button will permanently silence the alarm tone and the System Status Light is solid yellow until the power is cycled or patient monitoring begins. Should the alarm condition be created by a low battery condition, plug the device into AC power immediately. ALARM MUTE When the Rad-87 is set to Interface Alarms "Off" (muting the SpO2 and BPM audible alarms at the device) and SpO2 or BPM alarms occur, the Alarm Bell flashes red and the System Status Light is solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. The audible alarm (SpO2, BPM) activates at the interfaced system while the audible alarm is muted at the device. Once the SpO2 or BPM alarm condition is resolved and there are no other system or parameter/measurement alarms, the Alarm Bell stops flashing, the System Status Light changes to solid green and the audible alarm at the interfaced system deactivates. NOTE: The Rad-87 reverts to Interface Alarms "On" during power interruptions or when the interface connection is lost. This ensures that the Rad-87 provides SpO2 and BPM audible alarms when connection to the interfaced system becomes compromised. 5-6 Rad-87 Pulse CO-Oximeter Operators Manual a l a r m s a n d m e s s a g e s 5 MESSAGES The Rad-87 Pulse CO-Oximeter will indicate other data or system errors. Message conditions for the Rad-87 follow:
DISPLAY TYPE SOLUTION SCROLLING ZEROS Pulse Search PULSE BAR (SIQ) TURNS RED Low Signal IQ PERFUSION BAR (PI) TURNS RED Low Perfusion PARAMETER/
MEASUREMENT LABEL AND NUMBER FLASH Wait for found pulse. (This Search should occur whenever a sensor is first applied to a patient). 1. Rule out occlusion of blood flow. 2. Verify placement of sensor. 1. Rule 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. Assess /address patient condition. Alarm Limit Exceeded Re-set alarm limits if indicated. System Fault Return for service. There are several error codes, all error codes require return of the device to an authorized service center for repair. See Section 9, Service and Repair. Defective Sensor Replace sensor. Unrecognized Sensor Connect appropriate sensor. Interference Detected Ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Rad-87 Pulse CO-Oximeter Operators Manual 5-7 5 a l a r m s a n d m e s s a g e s M e s s a g e s c o n t i n u e d DISPLAY TYPE SOLUTION 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 too low Connect device to AC Power to charge the battery. No Cable Connected Connect appropriate cable to unit. Defective cable Replace cable 5-8 Rad-87 Pulse CO-Oximeter Operators Manual g t r o u b l e s h o o t i n g 6 Troubleshooting The following chart describes what to do if the Rad-87 system does not operate properly or fails. PROBLEM TYPE SOLUTION DEVICE DOES NOT POWER ON Low battery/ not plugged into AC power supply Connect the AC Power Cord to the Rad-87 and to an AC outlet. Make sure that the AC Power Indicator light is on. BATTERY RUN-TIME IS SIGNIFICANTLY REDUCED Low battery CONTINUOUS SPEAKER TONE Internal Failure Contact Technical Services or your local Masimo representative. Device requires service. Press the Alarm Silence Button. If alarm continues to sound, power down device. If the power button does not turn 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 Enabled Internal Failure The System Status Light flashes yellow. See Section 4, Alarm Silence. Use auxilary power down method by pressing and holding Sensitivity and Display Buttons simultaneously. Return for service. BUTTONS FAIL TO WORK WHEN PRESSED SENSOR OFF MESSAGE NO SENSOR MESSAGE LOW PERFUSION
(PI BAR TURNS RED) LOW SIGNAL QUALITY Sensor not connected to patient properly. Sensor is damaged. Properly reapply the sensor on the patient and reconnect the sensor to the unit or patient cable. If the sensor is damaged, replace the sensor. Sensor is disconnected from patient cable. Sensor connected upside down into patient cable. Improper sensor type. Poorly perfused site. Sensor is too tight. A disorder such as hypo-
thermia, vasoconstriction, hypovolemia, peripheral vascular disease or anemia. Sensor is damaged. Improper sensor type or application. Excessive motion relative to perfusion. Sensor or cable is dam-
aged or not functioning. Check to see if the sensor LED is flashing. Disconnect and reconnect the sensor. If the LED fails to operate, replace the sensor. Verify proper sensor and sensor size for the patient. Check and see if blood flow to the site is restricted. Be sure that the sensor is not on too tight. Set unit to MAX sensitivity. Warm the patient or sensor site. Move sensor to better perfused site. Check and see if blood flow to the site is restricted. Check the placement of the sensor. Re-apply sensor or move to a different site. Replace sensor or cable. Rad-87 Pulse CO-Oximeter Operators Manual 6-1 6 t r o u b l e s h o o t i n g T r o u b l e s h o o t i n g c o n t i n u e d PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION SpO2 VALUES DO NOT CORRELATE WITH CLINICAL ASSESSMENT OR ABGs. Low perfusion or sensor displacement. PULSE SEARCH MESSAGE Device is searching for pulse. Check for error messages. See section 5 Messages for recommended corrections. Check placement of sensor or if it is too tight. Reapply sensor or select a new site. Set to MAX sensitivity and confirm that the sensor is securely on the patient. Refer to sensor Directions For Use. If device fails to display within 30 seconds, disconnect and reconnect sensor to patient. If pulse search continues, move sensor to better perfused site. UNEXPECTED SpO2, SpCO, SpMet or SpHb READING Low SIQ or Perfusion Index
(PI) values. Reposition sensor to site with strong SIQ and PI. Submit blood sample for laboratory CO-Oximetry test for comparison. Inappropriate sensor size or sensor measurement location. Verify proper sensor for patient size. Verify proper sensor site. UNEXPECTED HIGH SpCO READING Possible elevated methe-
moglobin level*. Low battery/ not plugged into AC power supply. Submit blood sample for laboratory CO-Oximetry test. Connect the AC Power Cord to the Rad-87 and to an AC outlet. Make sure that the AC Power Indicator light is on. Verify/set 50/60hz menu setting. See section 3, Rad-87 Power Requirements. Verify proper sensor and sensor size for the patient. Shield the sensor from excessive or strobing light. Interference from line-fre-
quency induced noise. Inappropriate sensor or sensor size. Excessive ambient or strobing light. Also, see Section 4, Successful Monitoring for additional information. DIFFICULTY OR NO SpO2/SpCO/SpMet/SpHb READING Excessive motion. DIFFICULTY OR NO SpCO/
SpMet/SpHb READING Inappropriate sensor or sensor size. Excessive ambient or strobing light. Minimize or eliminate motion at the monitoring site. Verify use of an SpCO/SpMet/SpHb capable sensor. Verify proper sensor size for the patient. Shield the sensor from excessive or strobing light. PRINT FUNCTION DOES NOT WORK WIRELESS RADIO NO CONNECTION Wrong serial cable is used. Make sure a null modem cable is used. Radio Off. Confirm the Wireless Radio is ON. Network settings are not configured correctly. No/inadequate wireless coverage. Confirm wireless network settings. Confirm wireless coverage. 6-2 Rad-87 Pulse CO-Oximeter Operators Manual p s p e c i f i c a t i o n s 7 R a d - 8 7 s p e c i f i c a t i o n s PERFORMANCE Measurement Range SpO2:
SpMet:
SpCO:
SpHb SpOC Pulse Rate:
Perfusion Index:
Pleth Variability Index:
Accuracy:
Arterial Oxygen Saturation Accuracy1 Saturation No Motion Adults, Infants, Pediatrics Saturation No Motion2 Adults, Infants, Pediatrics Neonates*
Motion3 Low Perfusion4 Adults, Infants, Pediatrics, Neonates Adults, Infants, Pediatrics, Neonates Pulse Rate Accuracy5 Pulse Rate:
No Motion Adults, Infants, Pediatrics, Neonates Adults, Infants, Pediatrics, Neonates Motion4 Low Perfusion Adults, Infants, Pediatrics, Neonates Carboxyhemoglobin saturation accuracy (%SpCO)1 Adults, Infants, Pediatrics Methemoglobin saturation accuracy (%SpMet)1 Adults, Infants, Pediatrics, Neonates Total Hemoglobin accuracy (SpHb g/dl)9 Adults, Pediatrics Resolution Arterial Oxygen Saturation (%SpO2) Carboxyhemoglobin Saturation (%SpCO) Methemoglobin Saturation (%SpMet) Total Hemoglobin (SpHb g/dl) Pulse Rate (bpm)
* Only Rainbow sensors provide 2% for Neonates 0 -100%
0 - 99.9%
0 - 99%
0 - 25 g/dl 0 - 35 ml of O2/dl of blood 25 - 240 (bpm) 0.02% - 20%
0 - 100%
60% to 80%
3%
70% to 100%
2%
3%
3%
2%
25 - 240 (bpm) 3 bpm 5 bpm 3 bpm 1% - 40% 3%
1% - 15% 1%
8 - 17 g/dl 1 g/dl 1%
1%
0 .1%
0 .1 g/dl 1 bpm Rad-87 Pulse CO-Oximeter Operators Manual 7-1 7 s p e c i f i c a t i o n s ELECTRICAL AC Power requirements:
Power consumption:
Batteries Type:
Capacity (battery life):
Charging time:
ENVIRONMENTAL Operating Temperature:
Transport/Storage Temperature:
Operating Humidity:
Operating Altitude:
PHYSICAL CHARACTERISTICS Dimensions:
Weight:
Trending 72 hours of trending at 2 second resolution Mode Averaging mode:
100 - 240 VAC, 47-83 Hz 15 VA max. Sealed lead acid up to 4 hours6 8 hours 41F to 104F (5C to 40C)
-40F to 158F (-40C to +70C)7 5% to 95%, non-condensing 500 mbar to 1060 mbar pressure
-1000 ft to 18,000 ft (-304 m to 5,486 m) 8.2 x 6.0 x 3.0 (20.8 cm x 15.2cm x 7.6 cm) 2.1 lbs. = .908 Kg. = 32 oz Sensitivity:
Alarms Audible and visual alarms for high low saturation and pulse rate (SpO2 range 1% - 99%, SpCO range 1% - 98%, SpMet range 1% - 99.5%, SpHb range1 g/dl - 24.5 g/dl, PI range 0.03% - 19%, PVI range 1% - 99%, pulse rate range 30 - 235 bpm) Sensor condition, system failure and low battery alarms 2, 4, 8,10, 12, 14 or 16 seconds8 Normal, Maximum9, and APOD High Priority Audible Alarm:
Medium Priority Audible Alarm Low Priority Audible Alarm:
Alarm Volume:
High Priority Visual Alarm:
Medium Priority Visual Alarm 800 Hz tone, 5 pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s 500 Hz tone, 3 pulse burst, repeat time: 5s 500 Hz tone, 3 pulse burst, repeat time: 5s High: 85 dB (min) Low: 45 dB (min) Red flashing 2 sec. (0-5 Hz) Yellow flashing 4 sec (0.25 Hz) Low Priority Visual Alarm:
Display/Indicators Display Language English (default) Data display: %SpO2, %SpCO, %SpMet, SpHb g/dl, SpOC ml/dl, pulse rate, alarm status, status messages, Signal IQ, perfusion idex, pleth variability index, sensitivity modes, wireless radio connection, system status light. Solid yellow Type:
Display update rate:
LED 1 second 7-2 Rad-87 Pulse CO-Oximeter Operators Manual s p e c i f i c a t i o n s 7 PHYSICAL CHARACTERISTICS (CONTINUED) Output Interface Serial RS-232 Wireless Radio (if installed) Nurse Call Philips VueLink, RadNet, Patient SafetyNet Compliance Safety Standard for Medical Equipment 802.11 a/b/g EC 60601-1-2nd Edition UL 60601-1 CAN/CSA C22.2 No. 601-1 JIS 0601-1 Type of Protection Class 1 (AC power), Internally powered (battery power) Degree of Protection-(Pulse CO-Oximeter Cable):
Mode of Operation:
Type BF, Defib Proof Applied-Part Continuous 60601-1-2 EMC Standard 1 SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO2, 0% - 40% SpCO and 0% - 15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135 days old and weighting between 0.5 and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70 - 100% SaO2 and 0.5 - 2.5% HbMet with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet. Contact Masimo for testing specifications. 2 The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation 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. 3 The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation 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 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-87 has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2* simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70-100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 5 Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. 6 This represents approximate run time at the lowest indicator brightness and pulse tone turned off using a fully charged battery without radio power. 7 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20C to +30C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened. 8 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from 2-4 and 4-6 seconds, respectively. 9. SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8 g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington. Rad-87 Pulse CO-Oximeter Operators Manual 7-3 7 s p e c i f i c a t i o n s S e r i a l i n t e r f a c e s p e c i f i c a t i o n s The digital interface for serial communication is based on the standard RS-232 protocol. The Rad-87 Pulse CO-Oximeter by default always outputs ASCII 1 text data through the serial port, unless the user selects a different output mode in the Output menu. To interface with the Rad-87 and receive serial text data, simply connect a serial interface cable with a serial output connector located on the back of the Rad-87. NOTE: Trend data packets are collected at 2 second intervals. Each data packet contains: the date, time, SpO2, perfusion index, SpMet, SpCO, SpHb, PI, pulse rate, and alarm and exception values (in ASCII 2 format). SERIAL INTERFACE SETUP To interface with the Rad-87 serial port, set the following communication parameters on the interfacing serial device:
PARAMETER SETTING BAUD RATE NUMBER OF BITS PER CHARACTER PARITY BITS HANDSHAKING CONNECTOR TYPE 9600 Baud bidirectional 8 None 1 start, 1 stop None Female DB-9 The pin-outs for the RS-232 connector are shown in the following table:
PIN 1 2 3 4 5 6 7 8 9 SIGNAL NAME No Connection Receive data RS-232 9 V (5 Vmin) Transmit data RS-232 9 V (5 Vmin) No Connection Signal Ground Reference for COM signals No Connection No Connection No Connection No Connection 7-4 Rad-87 Pulse CO-Oximeter Operators Manual s p e c i f i c a t i o n s 7 SERIAL PRINTER SETUP To print the SpO2 and pulse rate data in ASCII 2 format on a serial printer, simply connect the serial printer to the serial port and set output mode to ASCII 2. Once serial communication is established, the Rad-87 will automatically start printing the ASCII 2 text data. WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE RS-232 SERIAL PORT MUST BE IEC-60950 COMPLIANT. Nurse call specifications 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 or opening depending on alarm, Low Signal IQ events or both. In addition the nurse call polarity can be inverted to accommodate various nurse call stations requirements. The nurse call relays have the following electrical specification per switch:
PARAMETER MAX VOLTAGE SPECIFICATION 36 VDC or 24 VAC peak WARNING: THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE ALARMS ARE SILENCED AND NURSE CALL SETTING IS SET TO ALARMS. Rad-87 Pulse CO-Oximeter Operators Manual 7-5 p s e n s o r s & p a t i e n t c a b l e s 8 I n t r o d u c t i o n This section covers the use and cleaning of Masimo sensors and patient cables. Before use of any sensor, carefully read the sensors Directions for Use. Use only Masimo sensors and cables with the Rad-87 Pulse CO-Oximeter. Other transducers, sensors and cables may affect Rad-87's performance. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity, correct positioning and adhesion of the sensor. CAUTIONS:
DO NOT USE DAMAGED SENSORS OR PATIENT CABLES. DO NOT USE A SENSOR OR PATIENT CABLE WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR OR PATIENT CABLE IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE NOT WATERPROOF). UNLESS OTHERWISE SPECIFIED, DO NOT STERILIZE SENSORS OR PATIENT CABLES BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS. DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE ANY MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES 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 SENSOR BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT. SELECTING A MASIMO SET SENSOR When selecting a sensor, consider the patients weight, the adequacy of perfusion, the available sensor sites, and the duration of monitoring. For more information refer to the following tables or contact your Sales Representative. Use only Masimo sensors and sensor cables. Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented in the Directions for Use accompanying the sensor. Monitor, cables and sensors must be compatible to ensure optimal performance. Incompatible components effect operation or data recovery. High intensity extreme lights (such as pulsating strobe lights) directed on the Pulse CO-Oximeter sensors, may not allow the sensor to obtain vital sign readings. High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor. To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. SENSOR APPLICATION INSTRUCTIONS Unless indicated otherwise in the directions for use, reposition reusable sensors at least every 4 hours and for adhesive sensors inspect the site at least every 8 hours or sooner. If indicated by circulatory condition or skin integrity, reapply to a different monitoring site. Rad-87 Pulse CO-Oximeter Operators Manual 8-1 8 s e n s o r s & p a t i e n t c a b l e s M a s i m o R a i n b o w S e n s o r s Masimo Rainbow sensors must be used for the Rad-87 Pulse CO-Oximeter parameters to enable measurement of Carboxyhemoglobin (SpCO), Methemoglobin (SpMet) and Total Hemoglobin (SpHb). Rainbow sensors will only measure SpO2 and pulse rate on devices without Masimo Rainbow SET Technology. RAINBOW REUSABLE SENSORS SpO2, SpCO, SpMet, SpHb and pulse rate accuracy for the Rainbow sensors is specified in the following 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 SpHb Conc. Accuracy DCI
> 30 kg DCIP 10 - 50 kg 60 - 80 3%
70 -100 2%
60 - 80 3%
70 -100 2%
3% 3 bpm 5 bpm 2% 3 bpm 3%
1%
1 g/dl 3% 3 bpm 5 bpm 2% 3 bpm 3%
1%
1 g/dl RAINBOW DIRECT CONNECT SENSORS SpO2, SpCO, SpMet and pulse rate accuracy for the Rainbow sensors is specified in the following table. Rainbow Direct Connect sensors connect to the device directly. SENSOR DCI-dc3 DCI-dc12 DCIP-dc3 DCIP-dc12 Weight Range
> 30 kg 10 - 50 kg 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 60 - 80 3%
70 -100 2%
60 - 80 3%
70 -100 2%
3%
3 bpm 5 bpm 2%
3 bpm 3%
1%
3%
3 bpm 5 bpm 2%
3 bpm 3%
1%
SpO2, SpCO, SpMet, SpHb and pulse rate accuracy for the Rainbow sensors is specified in the following table. Rainbow Direct Connect sensors connect to the device directly. SENSOR DC-3 DC-12 DCP-3 DCP-12 Weight Range
> 30 kg 10 - 50 kg 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 SpHb Conc. Accuracy 60 - 80 3%
70 -100 2%
60 - 80 3%
70 -100 2%
3% 3 bpm 5 bpm 2%
3 bpm 3%
1%
1 g/dl 3% 3 bpm 5 bpm 2%
3 bpm 3%
1%
1 g/dl 8-2 Rad-87 Pulse CO-Oximeter Operators Manual s e n s o r s & p a t i e n t c a b l e s 8 M a s i m o S p O 2 S e n s o r s The Rad-87 may use standard Masimo LNOP, LNOPv and LNCS SpO2 sensors, when used with Red PC, Red LNC or Rainbow RC cables respectively. Select the appropriate patient cable to attach the LNOP or LNCS sensor to the device. RED DIRECT CONNECT SENSORS Masimo Red sensors can be used with the Rad-87 to enable measurement of SpO2 and pulse rate only. Red sensors will only function with oximeter devices equipped with Masimo Rainbow SET technology. Red Direct Connect sensors connect to the device directly. Pulse Rate Accuracy Motion Low Perfusion Accuracy Saturation Pulse Rate Saturation Accuracy No Motion Motion Weight Range No Motion SENSOR DC-3 DC-12 DCP-3 DCP-12
> 30 kg 10 - 50 kg 2%
2%
3%
3%
3 bpm 5 bpm 3 bpm 5 bpm 2%
2%
3 bpm 3 bpm LNOP REUSABLE SENSORS LNOP reusable sensors must be used in conjunction with Red PC cables. SENSOR LNOP DCI LNOP DCIP LNOP YI LNOP TC-I LNOP DC-195 LNOP TF-I Weight Range
> 30 kg 10 - 50 kg
> 1 kg
> 30 kg
> 30 kg
> 30 kg No Motion Saturation Accuracy Motion 3%
3%
3%
N/A 3%
N/A 2%
2%
2%
3.5%
2%
2%
Pulse Rate Accuracy Motion No Motion 5 bpm 3 bpm 3 bpm 5 bpm 3 bpm 5 bpm 3 bpm 3 bpm 3 bpm 5 bpm N/A N/A 2%
2%
N/A 3.5%
2%
2%
Low Perfusion Accuracy Pulse Rate Saturation 3 bpm 3 bpm N/A 3 bpm 3 bpm 3 bpm NOTE: The LNOP TF-I and TC-I sensors were not validated under motion conditions. Rad-87 Pulse CO-Oximeter Operators Manual 8-3 8 s e n s o r s & p a t i e n t c a b l e s LNOPvTM ADHESIVE SENSORS LNOPv adhesive sensors must be used in conjunction with Red PC cables SENSOR Weight Range Saturation Accuracy Motion No Motion 3%
3%
3%
2%
3%
2%
Pulse Rate Accuracy Motion 5 bpm 5 bpm 5 bpm No Motion 3 bpm 3 bpm 3 bpm Saturation Low Perfusion Accuracy Pulse Rate 3 bpm 3 bpm 3 bpm 2%
3%
2%
3 - 20 kg
< 3 kg
> 30 kg LNOPv In LNOPv Ne LNOPv Ad LNOP SPECIALTY SENSORS LNOP specialty sensors must be used in conjunction with Red PC cables No Motion Motion No Motion Motion Saturation Pulse Rate LNOP Newborn Infant
(thumb or great toe) Infant (finger or toe) LNOP Newborn Neonatal LNOP Trauma 3 - 30 kg 10 - 30 kg
< 3 kg
> 30 kg LNOP Blue 2.5 - 30 kg 2%
3%
3%
2%
60 - 80% 4%
70 - 100% 3.3%
80 - 100% 3%
3%
3%
3%
3%
N/A N/A N/A 3 bpm 5 bpm 3 bpm 5 bpm 3 bpm 5 bpm 3 bpm 3 bpm 3 bpm 3 bpm 5 bpm N/A N/A N/A 2%
3%
3%
2%
3%
3%
3%
LNCS REUSABLE SENSORS LNCS reusable sensors must be used in conjunction with Red LNC or Rainbow RPC cables 2%
2%
3.5%
2%
2%
> 30 kg 10 - 50 kg
> 30 kg
> 30 kg
> 1 kg 2%
LNCS DCI 2%
LNCS DCIP 3.5%
LNCS TC-I 2%
LNCS TF-I LNCS YI N/A NOTE: The LNCS TF-I and TC-I sensors were not validated under motion conditions. LNCS ADHESIVE SENSORS LNCS sensors must be used in conjunction with Red LNC or Rainbow RPC cables 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3%
3%
N/A N/A 3%
5 bpm 5 bpm N/A N/A 5 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm N/A Saturation Accuracy Motion No Motion Pulse Rate Accuracy No Motion Motion Low Perfusion Accuracy Saturation Pulse Rate SENSOR LNCS Adtx LNCS Adtx-3 LNCS Pdtx LNCS Pdtx-3 LNCS Inf-L LNCS Inf LNCS Inf-3 LNCS Neo-L LNCS Neo LNCS Neo-3 LNCS NeoPt-L LNCS NeoPt-L LNCS NeoPt-3 Weight Range
> 30 kg 10 - 50 kg 2%
2%
3 - 20 kg 2%
< 3 kg
> 40 kg
< 1 kg 3%
2%
3%
LNCS NeoPt-500
< 1 kg 3%
3%
3%
3%
3%
3%
3%
3%
3 bpm 5 bpm 3 bpm 5 bpm 2%
2%
3 bpm 3 bpm 3 bpm 5 bpm 2%
3 bpm 3 bpm 3 bpm 5 bpm 5 bpm 3%
2%
3 bpm 3 bpm 3 bpm 5 bpm 3%
3 bpm 3 bpm 5 bpm 3%
3 bpm 8-4 Rad-87 Pulse CO-Oximeter Operators Manual s e n s o r s & p a t i e n t c a b l e s 8 LNCS SPECIALTY SENSORS LNCS specialty sensors must be used in conjunction with Red LNC cables or Rainbow RPC cables. SENSOR LNCS Newborn Infant/Pediatric LNCS Newborn Neonatal LNCS Trauma Weight Range
< 3 kg
< 3 kg
> 30 kg Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy No Motion Motion No Motion Motion Saturation Pulse Rate 2%
3%
2%
3%
3%
3%
3 bpm 5 bpm 3 bpm 3 bpm 5 bpm 5 bpm 2%
3%
2%
3 bpm 3 bpm 3 bpm SENSOR ACCURACY Refer to Section 7, Specifications for SpO2, SpMet, SpCO, SpHb and pulse rate accuracy, unless otherwise specified in the previous tables:
Complete accuracy specifications are located in the sensor Directions For Use (DFU) and are specific for the type of Masimo sensor used. CLEANING AND REUSE OF MASIMO REUSABLE SENSORS AND CABLES Reusable sensors and patient cables can be cleaned per the following procedure:
1. Remove the sensor from the patient. 2. Disconnect the sensor from the patient cable. 3. Disconnect the patient cable from the monitor. 4. Wipe the entire sensor and/or patient cable clean with a 70% isopropyl alcohol pad. 5. Allow to air dry thoroughly before returning it to operation. CAUTION: CAREFULLY 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 emitter and detector windows are clear and the adhesive still adheres to the skin. NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly positioned. Reposition the sensor or choose a different monitoring site. CAUTION: DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE ANY MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM. CAUTION: TO PREVENT DAMAGE, DO NOT SOAK OR IMMERSE THE SENSOR IN ANY LIQUID SOLUTION. DO NOT ATTEMPT TO STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ANY METHOD OTHER THAN ETHYLENE OXIDE AS INDICATED. WARNING: TO AVOID CROSS CONTAMINATION ONLY USE MASIMO SINGLE USE SENSORS ON THE SAME PATIENT. Rad-87 Pulse CO-Oximeter Operators Manual 8-5 s e r v i c e / m a i n t e n a n c e 9 I n t r o d u c t i o n This chapter covers how to test the operation, properly clean and how to obtain service for the Rad-87 Pulse CO-Oximeter. Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. WARNING: ELECTRICAL SHOCK AND FLAMMABILITY HAZARD - BEFORE CLEANING THE RAD-87, ALWAYS TURN IT OFF AND DISCONNECT THE POWER CORD FROM THE AC POWER SUPPLY. The Rad-87 Pulse CO-Oximeter is a reusable device. The device is supplied and used non-
sterile. C l e a n i n g The outer surface of the Rad-87 Pulse CO-Oximeter can be 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 down using the following solvents:
Cidex Plus (3.4% Glutaraldehyde), 10% Bleach, and 70% Isopropyl Alcohol. CAUTIONS:
DO NOT AUTOCLAVE, PRESSURE STERILIZE, OR GAS STERILIZE THE DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID. USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW INTO RAD-87. THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS. DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE CLEANING COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE MATERIALS, OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD SCRATCH THE PANEL. DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER HARSH SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES AFFECT THE DEVICES MATERIALS AND DEVICE FAILURE CAN RESULT. Refer to Section 8, Cleaning and Reuse of Masimo Reusable Sensors and Cables for cleaning instructions of the sensor. Rad-87 Pulse CO-Oximeter Operators Manual 9-1 9 s e r v i c e / m a i n t e n a n c e B a t t e r y S e r v i c e WARNING: THE BATTERY SHOULD BE INSTALLED AND/ OR REMOVED FROM THE RAD-87 BY QUALIFIED PERSONNEL ONLY. P e r f o r m a n c e v e r i f i c a t i o n To test the performance of the Rad-87 after repairs or during routine maintenance, follow the procedure outlined in this section. If the Rad-87 fails any of the described tests, discontinue its use and correct the problem before returning the device back to the user. Before performing the following tests verify that the device is connected to AC power. Also disconnect any patient cables or probes or serial cables from the instrument. POWER-ON SELF-TEST:
1. Turn the monitor on by depressing the Power. For about 2 seconds all available LEDs are illuminated and a brief beep tone sounds. The Rad-87 begins normal operation. 2. KEY PRESS BUTTON TEST:
1. With the exception of the Power, press each button and verify that the device 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, depress the alarm limits button and enter the alarm menu. Change the High Saturation Alarm parameter to a value below the currently selected value, and accept the change. Verify that the newly set parameter is shown on the Saturation Alarm Limit Display. 2. 3. Return the High Saturation Alarm parameter to its original setting. 4. Repeat steps 1 to 3 for the following alarm parameters:
Low SpO2 Low and High pulse rate High SpMet (optional feature) High SpCO (optional feature) Low and High SpHb 5. Reset the alarm limits again to the original settings. 9-2 Rad-87 Pulse CO-Oximeter Operators Manual s e r v i c e / m a i n t e n a n c e 9 LED BRIGHTNESS:
1. With the monitor turned on, press the Brightness Button once to enter the LED Brightness menu. The display will show the default setting Level 2. 2. Continue pressing the Brightness Button to scroll through the settings. 3. Press the Enter Button to accept the desired setting and exit to the home display screen. Turn the Rad-87 off and then on again. TESTING THE RAD-87 WITH MASIMO SET TESTER (OPTIONAL):
1. 2. Connect the Masimo SET Tester to the Pulse CO-Oximeter Patient Cable Connector. 3. 4. 5. 6. Verify that within 20 seconds all available pulse bars display. Verify that the SpO2 measurement is between 79% and 84%. Verify that the pulse rate measurement is between 55 bpm and 65 bpm. Set the SpO2 low alarm limit to 90 (see Section 4, Setup Menu Level 1, Parameter/
Measurement Alarm Limits - Screen 1, and Setup Menu Level 2, Alarm Volume). Verify that an audible alarm activates, the SpO2 measurement and the SpO2 parameter label are flashing, and the Alarm Bell and the System Status Light are flashing red. Press the Alarm Silence Button once and verify that the alarm is silenced and the Alarm Bell is flashing red and the System Status Light is flashing red. 7. 8. 9. Wait 120 seconds and verify that the alarm silence times out, the audible alarm is activated again and the Alarm Bell and System Status Light are flashing red. 10. Press the up arrow button several times and verify that the loudness of the pulse beep tone increases. 11. Press the down arrow button and verify that the loudness of the pulse beep tone decreases until the pulse beep tone is turned off. 12. Reset the device to original settings and remove the tester to complete the procedure. Rad-87 Pulse CO-Oximeter Operators Manual 9-3 9 s e r v i c e / m a i n t e n a n c e 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 device repaired. WARNING: AN OPERATOR MAY ONLY PERFORM MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE REPAIR OF THIS EQUIPMENT. Please clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Section 9, Cleaning. Make sure the equipment is fully dry before packing. To return the Rad-87 Pulse CO-Oximeter for service, please follow the Return Procedure. RETURN PROCEDURE Please clean contaminated/dirty equipment before returning and make sure it is fully dry before packing the equipment. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely in the original shipping container if possible and enclose or include the following information and items:
A letter describing in detail any difficulties experienced with the Rad-87. Please include the RMA number in the letter. Warranty information a copy of the invoice or other applicable documentation must be included. Purchase order number to cover repair if the device is not under warranty, or for tracking purposes if it is. Ship-to and bill-to information. Person (name, telephone/Telex/fax number, and country) to contact for any questions about the repairs. A certificate stating the Rad-87 has been decontaminated for bloodborne pathogens. Return the Rad-87 to the following shipping address:
For USA and Asia Pacific:
Masimo Corporation 40 Parker Irvine, California 92618 Tel: 949-297-7000 FAX: 949-297-7001 For Europe:
Masimo Europe Limited 304 RN6, Le Bois des Cotes 2 69760 Limonest France Tel: +33 (0) 472 17 93 70 FAX: +33 (0) 478 35 78 08 All other locations:
Contact your local Masimo Representative 9-4 Rad-87 Pulse CO-Oximeter Operators Manual s e r v i c e / m a i n t e n a n c e 9 Sales & End-User License Agreement THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (PURCHASER) AND MASIMO CORPORATION (MASIMO) FOR THE PURCHASE OF THIS PRODUCT (PRODUCT) AND A LICENSE IN THE INCLUDED OR EMBEDDED SOFTWARE (SOFTWARE). EXCEPT AS OTHERWISE EXPRESSLY AGREED IN A SEPARATE CONTRACT FOR THE ACQUISITION OF THIS PRODUCT, THE FOLLOWING TERMS ARE THE ENTIRE AGREEMENT BETWEEN THE PARTIES REGARDING YOUR PURCHASE OF THIS PRODUCT. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PRODUCT, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGES, WITH YOUR SALES RECEIPT TO MASIMO FOR A FULL REFUND. Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that:
(i) each new Product and the Software media as delivered are free from defects in workmanship or materials, and (ii) the Product and Software will perform substantially as labeled in the directions for use. Masimos sole obligation under this warranty is to repair or replace any Product or Software that is covered under warranty. Batteries are warranted for six (6) months. To request a replacement under warranty, 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 other shipping costs shall be the responsibility of Purchaser. Exclusions The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed because of: a) modification of the Product or Software without Masimos 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 Masimo; e) use of the Product and Software in ways or in environments for which they are not labeled; and f) neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any Product that has been reprocessed, reconditioned or recycled. This warranty also does not apply to any Products provided to Purchaser for testing or demonstration purposes, any temporary Products modules or any Products for which Seller does not otherwise receive a usage or purchase fee; all such Products are provided AS-IS without warranty. Rad-87 Pulse CO-Oximeter Operators Manual 9-5 9 s e r v i c e / m a i n t e n a n c e Exclusions continued THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO THE PRODUCT AND SOFTWARE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MASIMO SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM THE USE OR LOSS OF USE OF ANY PRODUCTS OR SOFTWARE. IN NO EVENT SHALL MASIMOS LIABILITY ARISING FROM ANY PRODUCT AND SOFTWARE (UNDER CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY PURCHASER FOR THE PRODUCTS GIVING RISE TO SUCH CLAIM. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT CANNOT LEGALLY BE DISCLAIMED BY CONTRACT. End-User License 1. Grant of License: In consideration of payment of the Software license fee, which is part of the price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable
(except as set forth below) license (License), without right to sublicense, to use the copy of the Software in connection with Purchasers use of the Product 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 and interests in the Software and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be deemed the purchase or sale of a Software License as set forth herein. 9-6 Rad-87 Pulse CO-Oximeter Operators Manual s e r v i c e / m a i n t e n a n c e 9 Restrictions 1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchasers failure to abide by the terms of this Agreement. Nothing in this License provides any rights beyond those provided by 17 U.S.C. 117. 3. 2. Use Restrictions: Purchaser may physically transfer the Product 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, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials. Transfer Restrictions: In no event may Purchaser 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 of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchasers rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void. 4. U.S. Government Rights: If Purchaser is acquiring Software (including the related documentation) on behalf of any part of the United States Government, the following provisions apply: the Software and documentation are deemed to be commercial software and commercial computer software documentation, respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the Software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement. Rad-87 Pulse CO-Oximeter Operators Manual 9-7 10 Section 10 Part Numbers p a r t n u m b e r s P a r t N u m b e r s PART NUMBER 32750 32751 32752 32753 32754 32755 32756 32757 32758 32759 DESCRIPTION Rad-87 Operator's Manual (SpHb), French Rad-87 Operator's Manual (SpHb), German Rad-87 Operator's Manual (SpHb), Italian Rad-87 Operator's Manual (SpHb), Spanish Rad-87 Operator's Manual (SpHb), Japanese Rad-87 Operator's Manual (SpHb), Dutch Rad-87 Operator's Manual (SpHb), Portuguese Rad-87 Operator's Manual (SpHb), Danish Rad-87 Operator's Manual (SpHb), Swedish Rad-87 Operator's Manual (SpHb), Chinese Please visit our website, www.masimo.com, for updated information about Masimo products. Rad-87 Pulse CO-Oximeter Operators Manual 10-1 www.masimo.com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo. 8 0 6 0
E 5 2 5 4
4 7 3 1 3
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2008-09-24 | 5745 ~ 5805 | DTS - Digital Transmission System | Original Equipment |
2 | 5180 ~ 5240 | NII - Unlicensed National Information Infrastructure TX |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2008-09-24
|
||||
1 2 | Applicant's complete, legal business name |
Masimo Corporation
|
||||
1 2 | FCC Registration Number (FRN) |
0016800161
|
||||
1 2 | Physical Address |
52 Discovery
|
||||
1 2 |
Irvine, California 92618
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
d******@nwemc.com
|
||||
1 2 |
d******@nwmec.com
|
|||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
VKF
|
||||
1 2 | Equipment Product Code |
RAD87A
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
A**** J****
|
||||
1 2 | Title |
EMC Manager
|
||||
1 2 | Telephone Number |
949-2********
|
||||
1 2 | Fax Number |
949-2********
|
||||
1 2 |
a******@masimo.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | RAD-87 | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power is conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons. The antenna(s) for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This transmitter is restricted to indoor use in the 5150MHz to 5250MHz frequency range. Users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 2 | Output power is conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons. The antenna(s) for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This transmitter is restricted to indoor use in the 5150MHz to 5250MHz frequency range. Users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Northwest EMC, Inc.
|
||||
1 2 | Name |
G****** K******
|
||||
1 2 | Telephone Number |
503-8******** Extension:
|
||||
1 2 | Fax Number |
503-8********
|
||||
1 2 |
g******@nwemc.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2412 | 2462 | 0.02888 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15C | CC | 5745 | 5805 | 0.01938 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15E | CC | 5180.00000000 | 5240.00000000 | 0.0192300 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC