LAB3371D RAD 8 Pulse Ox User Manual
User Manual: RAD-8 Pulse Ox User Manual
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OPERATOR’S MANUAL Signal Extraction Pulse Oximeters Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual RadNet, PI, APOD and LNOPv are trademarks of Masimo Corporation. © 2007 Masimo Corporation. Masimo, Signal IQ, Discrete Saturation Transform, DST, Satshare, SET, , FastSat, Rad-8, Radlink, FastSat, SIQ, LNOP, LNCS and are federally registered trademarks of Masimo Corporation. Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 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. MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 No. 601.1 80FK MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33 EC REP EU Authorized Representative for Masimo Corporation: For further information contact: Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. NOTICE Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. Do not operate the Rad-8 pulse oximeter without completely reading and understanding the instructions in this manual. General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-8 pulse oximeter are prerequisites for its proper use. The Rad-8 Operating Instructions provide the necessary information for proper operation of all Rad8 pulse oximeter models. i ii The pulse oximeter is NOT intended for use as an apnea monitor. A pulse 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 patient’s condition. The pulse oximeter is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read and understood before use. Electric shock hazard. Do not open the pulse oximeter cover except to replace the battery of the unit. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. Only a qualified operator may perform maintenance procedures specifically 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 pulse oximeter or accessories in any position that might cause it to fall on the patient. Do not lift the pulse oximeter by the patient cable. Interfering Substances: Carboxyhemoglobin and Methemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. Severe anemia may cause erroneous SpO2 readings. Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. If using pulse oximetry during full body irradiation, keep the sensor out of the irradiation field. If sensor is exposed to the irradiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period. Always remove the sensor from the patient and completely disconnect the patient from the pulse oximeter before bathing the patient. Do not place the pulse oximeter where the controls can be changed by the patient. Do not place the pulse oximeter face against a surface. This will cause the alarm to be muffled. ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the pulse oximeter to obtain vital sign readings. A functional tester cannot be utilized to assess the accuracy of the pulse oximeter or any sensors. Consult the manufacturer for help. ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual ■ Reorient or relocate the receiving device. Increase the separation between the equipment. ■ 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. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. 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: ■ ■ The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds. Disposal of product - Comply with local laws in the disposal of the unit and/or its accessories. ■ ■ Patient Safety - If a sensor or cable is damaged in any way, discontinue use immediately. Failure of Operation - If the pulse oximeter fails any part of the setup procedures remove the pulse oximeter from operation until qualified service personnel have corrected the situation. ■ ■ Do not place containers containing liquids on or near the pulse oximeter. Liquids spilled on the pulse oximeter may cause it to perform inaccurately or fail. ■ ■ Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain. Excessive moisture can cause the pulse oximeter to perform inaccurately or fail. ■ Explosion hazard. Do not use the pulse oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. Do not place the pulse oximeter on electrical equipment that may affect the pulse oximeter, preventing it from working properly. ■ The Rad-8 Compact pulse 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. ■ SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES iii iv 2-1 2-2 2-4 2-5 3-1 3-1 3-1 3-1 3-2 3-2 SECTION 2 - SYSTEM DESCRIPTION Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rad-8 front panel controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rad-8 rear panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 3 - SETUP Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unpacking and inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparation for monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rad-8 power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial battery charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual SECTION 4 - OPERATION Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Basic operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 General Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Factory Default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Successful SpO2 monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Numeric Display - SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Masimo Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Numeric Display - Pulse Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Signal IQ and Pulse bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Actions To Be Taken. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Low Battery Audible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Normal patient monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Rad-8 front panel control operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 Menu Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 Setup Menu Level 1 – Alarm features and sensitivity. . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 Setup Menu Level 2 – Button volume, LED brightness and factory default settings. 4-10 Setup Menu Level 3 - Clear trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10 1-1 1-2 1-3 1-3 1-3 1-4 1-4 1-4 1-5 1-5 1-5 1-6 1-6 SECTION 1 - OVERVIEW About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warnings, cautions and notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Features and Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pulse Oximetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Principle of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Functional vs. Fractional Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measured vs. Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Masimo SET Signal Extraction Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Masimo SET Parallel Engines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Masimo SET DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . table of contents 7-1 7-1 7-1 7-1 7-1 7-2 7-3 7-3 7-4 7-4 7-4 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual SECTION 8 - SENSORS & PATIENT CABLES Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Masimo SpO2 sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Selecting a Masimo SET Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Sensor Application Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 ® LNOP Direct Connect Reuseable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 ® LNOP Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 SECTION 7 - SPECIFICATIONS Rad-8 specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Serial interface specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Serial Interface Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Serial Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nurse call specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 6 - TROUBLESHOOTING Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 5-1 5-1 5-2 5-3 5-3 5-4 4-11 4-11 4-12 4-13 4-13 4-13 4-13 4-14 4-14 4-14 4-14 4-15 4-15 4-15 4-15 4-16 4-16 4-16 SECTION 5 - ALARMS AND MESSAGES Alarm identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm Silence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm Silenced Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setup Menu Level 4 - Set date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setup Menu Level 5 - Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Output Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Philips VueLink setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RadNet Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RadLink Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special Menu – Standard, Home and Sleep mode . . . . . . . . . . . . . . . . . . . . . . . . . . Home Mode operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sleep mode Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trend setup and use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TrendCom Utility Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TrendCom Utility Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Erasing Trend Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trend Data Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Trend Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . table of contents v vi ® 9-1 9-1 9-2 9-2 9-4 9-4 9-4 9-5 9-5 9-5 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual SECTION 10 - ACCESSORIES Rad-8 Units and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 SECTION 9 - SERVICE AND MAINTENANCE Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . End-user license agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LNOP Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 ® LNOP Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 TM LNOPv Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 TM LNCS Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 TM LNCS Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Cleaning And Reuse Of Masimo Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Reattachment of Single Use Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Masimo SET patient cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Cleaning And Reuse Of Masimo SET Patient Cables. . . . . . . . . . . . . . . . . . . . . . . . . 8-4 table of contents SETUP describes how to setup the Rad-8 pulse oximeter for use. OPERATION describes the operation of the Rad-8 Pulse Oximetry system. ALARMS AND MESSAGES describes the alarm system messages. TROUBLESHOOTING describes troubleshooting information. SPECIFICATIONS gives the detailed specifications of the Rad-8 pulse oximeter. SENSORS AND PATIENT CABLES outlines how to use and care for the Masimo SET LNOP and LNCS sensors and Masimo SET patient cables. SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Rad-8 pulse oximeter. ACCESSORIES list the available Rad-8 accessories. SECTION 3 SECTION 4 SECTION 5 SECTION 6 SECTION 7 SECTION 8 SECTION 9 SECTION 10 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual SYSTEM DESCRIPTION describes the Rad-8 pulse oximeter system and its functions and features. OVERVIEW gives a general description of pulse oximetry. SECTION 2 SECTION 1 In addition to the safety section, this manual includes the following sections: Read the entire safety information section before you operate the monitor. This manual explains how to set up and use the Rad-8 pulse oximeter. Important safety information relating to general use of the Rad-8 pulse oximeter appears before this introduction. Other important safety information is located throughout the manual where appropriate. About This Manual overview Section 1 Overview 1 1-1 1-2 1 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual NOTE: This is a sample of a Note. Sample of Note: A NOTE is provided when extra general information is applicable. CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. Sample of Caution: 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. WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT. Sample of Warning: Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual INDICATIONS FOR USE The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Rad-8 family of pulse oximeters and accessories are indicated for use with adult, pediatric, Infant and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile and home environments. TM RadNet and RadLink® capability. Display capability on Philips/Agilent monitor through Philips VueLink function. ■ ■ 8 hours Internal battery life with fully charged battery Nurse call connection port ■ Serial output port Adjustable averaging 2 to 16 seconds ■ ■ Adjustable alarm volume ■ ■ Stores up to 72 hours of trending memory ■ TM Three sensitivity levels - Max, Normal and APOD Sleep study mode ■ ■ User defineable alarm limit settings ■ ® FastSat mode ■ Trauma mode One touch button access to alarms for High/Low saturation and High/Low pulse rate ■ ■ Audible and visual alarm for no sensor, sensor-off and low battery ■ SpO2, pulse rate, alarm, and perfusion index displays Signal I.Q. for signal identification and quality indication ■ ■ Lightweight, convenient compact design Proven for accurate monitoring in motion and low perfusion environments ■ ■ Applicable for use on neonate, infant, pediatric and adult patients ■ ® Clinically proven Masimo SET technology performance ■ FEATURES AND BENEFITS These features are common to the Rad-8 family: The Rad-8 family consists of two models: the vertical Rad-8 and the horizontal Rad-8. The Rad-8 family of pulse oximeters are noninvasive, arterial oxygen saturation and pulse rate monitors. The Rad-8 family features a multicolored LED display that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Perfusion Index (PI) and Signal Identification and Quality Indicator (Signal IQ ® ). 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. Product Description overview Warnings, cautions and notes overview 1 1-3 1-4 1 3 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. 2. 2. Recessed Photo Detector 1. Light Emitting Diodes (LEDs) Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Once the Rad-8 receives the signal from the sensor, it utilizes Masimo SET signal extraction technology for calculation of the patient’s functional oxygen saturation and pulse rate. The maximum of the skin surface temperature is measured at an ambient temperature of less than 106º F (41º C).This is verified by Masimo sensor skin temperature test procedures. 2 1 The Rad-8 pulse oximeter uses a two-wavelength pulsatile system to distinguish between oxygenated and deoxygenated blood. Signal data is obtained by passing red (rd) (660 nm wavelength) and infrared (ir) (905 nm wavelength) light through a capillary bed (for example a fingertip, a hand or a foot) and measuring changes in light absorption during the pulsatile cycle. This information may be useful to clinicians. The radiant power of the light is rated at 0.79mW (max.). See figure below. The Rad-8 utilizes a sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a photodiode (photodetector). The photodetector receives the light, converts it into an electronic signal and sends it to the Rad-8 for calculation. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). 3. Sensor 2. Patient Cable 1. PRINCIPLE OF OPERATION Pulse oximetry is governed by the following principles: 2 1 1. Instrument As a pulse rate (PR). 2. The following figure shows the general monitoring setup. As a percent value for arterial oxygen saturation (SpO2) and 1. Pulse Oximetry GENERAL DESCRIPTION Pulse oximetry is a continuous and non-invasive 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 fingertip for adults, and the hand or foot for neonates. The sensor connects to the pulse oximetry instrument directly 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 in two ways: overview 100 - (% carboxyhemoglobin + % methemoglobin) Fractional saturation x 100 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual MASIMO SET SIGNAL EXTRACTION TECHNOLOGY Masimo Signal Extraction Technology’s 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 non-arterial 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 filtering. Adaptive filters 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 identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor. MEASURED VS. CALCULATED SATURATION Oxygen saturation measurements obtained from a pulse oximeter are commonly compared to saturations calculated from the partial pressure of oxygen (PO2) obtained from an arterial blood gas sample. When comparing the two measurements and interpreting values, caution should be used, as the calculated value obtained from the blood gas sample may differ from the SpO2 measurement of the pulse oximeter. Different results are usually obtained from the blood gas sample if the calculated saturation is not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. Also, as blood gas samples are usually taken over a period of 20 seconds (the time it takes to draw blood) a meaningful comparison can only be achieved if the core oxygen saturation of the patient is stable and not changing over the period of time that the blood gas sample is taken. Functional saturation = FUNCTIONAL VS. FRACTIONAL SATURATION The Rad-8 is calibrated to measure and display functional saturation which is the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Rad-8 does not measure fractional saturation which is oxygenated hemoglobin expressed as a percentage of all measured hemoglobin. This includes measured dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin. To convert fractional saturation to functional saturation, the fractional saturation measurements must be converted according to: overview 1 1-5 1-6 1 MASIMO SET DST Digitized, Filtered & Normalized R/IR CONF MEAS CONF MEAS CONF MEAS CONF MEAS CONF MEAS Confidence Based Arbitrator Saturation Post Processor Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Proprietary Algorithm 5 Proprietary Algorithm 4 SST TM Adaptive Filter with DST® (Conventional Pulse Oximetry) R/IR MASIMO SET PARALLEL ENGINES overview Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Rad-8 family supports standardization of sensors and pulse oximetry technology throughout the hospital Rad-8 family supports the full line of Masimo sensors and patient cables (see Section 8, Sensors and Patient Cables) ■ ■ Rad-8 family offers full Masimo SET technology in a small compact device ■ The Rad-8 family of pulse oximeters are full featured pulse oximeters designed for ease of operation. All pulse 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 and the sensor cable connection is located on the left side of the Rad-8 horizontal and the bottom of the Rad-8 vertical. Introduction system description 2 2-1 2-2 2 Rad-8 Vertical 16 15 14 6 8 7 12 11 10 12 11 10 9 Used within the menu/setup system to move through setup options. Not active during normal patient monitoring Used to enter the setup menus and to select/activate certain entries within the menu/setup system. Used to enter the alarm menu to adjust Hi/Low SpO2 and heart rate alarm limits. Next Button Mode / Enter Button Alarm Limits Button Alarm Silence Button Pulse Rate Display 3 4 5 6 7 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual The pulse rate in beats per minute (bpm). When searching for a saturation and pulse, it will flash dashed lines. NOTE: The silence time can be set for 120, 90, 60 and 30 seconds. See Section 4 - Setup Menu Level 1.. Push once to temporarily silence the alarm for 120 seconds (default). Push a second time to return the unit to standard alarm monitoring after alarm condition has been corrected. NOTE: Pressing and holding down these buttons allow for the rapid scrolling of SpO2 and BPM alarm limits. Within the menu/setup system, these buttons are used to select values within each menu option. Up button Down button Patient Cable Connector Speaker Connects to a Direct Connect Spot Check (DCSC) sensor or Masimo Patient Cable with a sensor. The icon next to the sensor indicates defibrillation proof. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 19 18 Provides audible indication of alarm conditions, pulse tone and feedback for key-presses. Ensure the speaker is not covered or the unit is placed face-down on bedding or other sound absorbing surface. The AC Power Charging indicator is illuminated when the Rad-8 is connected to AC line power and the battery is charging. AC Power Charging Indicator 17 The yellow battery low indicator will illuminate with an audible alarm when the battery is low and requires recharging. Battery Low Indicator 16 No sensor indicator will illuminate when no sensor is connected and an audible alarm will sound. No Sensor Indicator No Sensor Sensor off indicator will illuminate when the sensor is off the patient and an audible alarm will sound. Used to set the unit into the most sensitive mode and fastest averaging time. Trauma Button Sensor Off Indicator The Perfusion Index provides an indication of the percentage of pulsatile signal to non pulsatile signal. The bar is highest when the quality of the perfused site is best. Perfusion Index Sensor Off Sensitivity Mode Button/ Indicator Used to set the unit in the FastSat Mode Used to set the unit into Maximum Sensitivity, Normal Sensitivity, or APOD Mode. Saturation Display FastSat Button/ Indicator The functional arterial hemoglobin oxygen saturation is displayed in units of SpO2. When searching for a saturation and pulse, it will flash dashed lines. Signal IQ / Pulse Bar 15 14 DESCRIPTION Rad-8 Horizontal 17 13 During saturation monitoring, use these buttons to adjust the volume of the pulse beep tone. 18 5 8 13 19 3 9 DESCRIPTION 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. CONTROL / INDICATOR system description Used to turn the unit on and off. 19 17 15 13 2 4 2 18 16 14 1 Power On / Off CONTROL / INDICATOR 1 3 5 7 12 11 1 2 4 6 8 9 10 Rad-8 front panel controls system description 2 2-3 2-4 2 Distributed by: Masimo Corporation Irvine, CA 92618 USA 4 EQUIPOTENTIAL GROUND CONNECTOR Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Use the Equipotential Ground Connector for grounding. 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 pulse oximeter to the main power for continuous operation and/or battery recharging. SERIAL OUTPUT CONNECTOR 2 POWER ENTRY MODULE Use the Serial Output Connector to connect a serial device, including a serial printer, RadNet Interface Module, RadLink Interface Module or PC, to the Rad-8. See Section 7, Serial Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant. 3 Use the 1/4” round Connector to interface with a nurse call system. This is a mono output and should be utilized with a mono cable. All external device connections to the Nurse Call Connector must be IEC-60950 compliant. NURSE CALL CONNECTOR 3 Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 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. Manufactured by: Masimo Corporation Irvine, CA 92618 USA Made in USA Rx Only P2 MEDICAL ELECTRICAL EQUIPMENT UL 60601-1/CAN/CSA C22.2 No. 601.1 80FK 100-240v~50-60 Hz 15VA MAX P1 RS-232 4 1 1 2 Rad-8 rear panel system description +70 C Fragile/breakable, handle with care Keep dry Storage temperature range: +70˚C to -40˚C Storage altitude range: +1600hPa to +500hPa Storage humidity range: 5% to 95% Underwriter's Laboratories Inc. approved Year of manufacture Federal law restricts this device to sale by or on the order of a physician (USA audiences only) Mark of Conformity to European Medical Device Directive 93/42/EEC Defibrillation Proof (see front panel) WEEE compliant Nurse Call Interface Caution, consult accompanying documents Equipotential Ground Terminal RS-232 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual +1060 hPa - +500 hPa 795 mmHg - 375 mmHg -40 C 5%-95% RH Rx Only SYMBOLS The following symbols are found on the back of the Rad-8 pulse oximeter or packaging and are defined below: SYMBOLS system description 2 2-5 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. ■ ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual CONNECT THE OXIMETER ONLY TO A HOSPITAL-GRADE RECEPTACLE (FOR HOSPITAL USE). ■ CAUTION: Connect a hospital grade power cable to the power entry module of the Rad-8 unit (IEC-320 connector type at the unit). Connect the power cable to an AC power source. Ensure that the unit is adequately powered by verifying that the AC power indicator on the Rad-8 is illuminated. The Rad-8 pulse oximeter is designed to operate on 100 to 240VAC, 50-60 Hz. The device is rated at 15 VA max. 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-8. CAUTION: DO NOT CONNECT THE RAD-8 PULSE OXIMETER TO AN AC OUTLET CONTROLLED BY A SWITCH. RAD-8 POWER REQUIREMENTS Always use a hospital grade, AC power cable to connect the Rad-8 pulse oximeter to an AC power source. The following sections of the manual describe the preparation, set-up and initial installation of the Rad-8 pulse oximeter. Preparation for monitoring 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. 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. Unpacking and inspection Before the Rad-8 pulse oximeter can be used in a clinical setting, it needs to be inspected and properly Introduction setup 3 3-1 3-2 3 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. ■ ■ 5% to 95%, non-condensing 500 mbar to 1060 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m) HUMIDITY OPERATING ALTITUDE Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual +5°C to +40°C, +41°F to +104°F TEMPERATURE OPERATING ENVIRONMENTAL CONDITIONS The Rad-8 should not be operated outside the following environmental conditions: INITIAL INSTALLATION Place the Rad-8 on a stable hard flat surface near the patient. Always place the Rad-8 unit on a dry surface. Maintain a minimum of 1 inch (2.54 cm) free space around the unit. Make sure that Rad-8 loudspeaker is not covered to avoid a muffled alarm sound. To charge the internal battery, plug in the AC power cord. Verify that the battery is charging. The green battery charging LED indicator on the unit will remain illuminated while the battery is charging. INITIAL BATTERY CHARGING Before use, the Rad-8 battery needs to be fully charged. IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY FUNCTIONAL. ■ setup Be familiar with its controls and operation. Understand its status and alarm messages (see Section 5, Alarm Identification, System Messages and Section 6, Troubleshooting). ■ ■ If utilizing a patient cable, select a sensor that is compatible with the oximeter and the patient before connecting it to the patient cable. See Section 8, Sensors and Patient Cables. If using a reusable sensor, make sure it opens and closes smoothly. Remove any substances that may interfere with the transmission of light between the sensor’s light source and photodetector. 3. Pulse Rate Low Alarm Limit and Pulse Rate High Alarm Limit, Averaging Time. ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual NOTE: “- - -” will flash on the numeric display until the SpO2 and pulse rate readings have stabilized (approximately 10 seconds). 10. On the display, verify the readings for SpO2 and pulse rate. SpO2 Low Alarm Limit and SpO2 High Alarm Limit, ■ Verify the display shows the following: 9. Mode setting: Standard (Std) or Sleep (SLP) or Home (Hnn) Verify the front-panel display is free of alarm and system failure messages (see Section 5, Alarms and Messages). 8. ■ Verify all front-panel indicators momentarily illuminate and a tone is heard. Press the Power button to turn the oximeter on. 6. 7. With a single patient adhesive or disposable sensor, connect the sensor to the patient cable with the logos lining up; make sure it is a firm connection. 5. Refer to the Directions for Use of the sensor before attaching the sensor to the patient. If using a single patient adhesive or disposable sensor, check that the emitter (red light) and the photodetector are properly aligned. Connect a patient cable or a direct connect sensor to the Patient Cable Connector of the Rad-8 pulse oximeter. Make sure it is a firm connection and the cable is not twisted, sliced or frayed. 2. 4. Inspect the oximeter case for damage. 1. GENERAL SETUP AND USE Basic operation Know how the oximeter derives its readings (see Section 1, Pulse Oximetry) ■ To operate the Rad-8 pulse oximeter effectively, the operator must: Introduction operation 4 4-1 4-2 4 The violated alarm limit and reading flash on the display. The Visual Alarm Indicator flashes. ■ ■ The alarm tone sounds. The Visual Alarm Indicator flashes. Disconnect the sensor from the patient cable or oximeter. Confirm that the “no sensor” indicator illuminates. ■ ■ ■ ■ Press the Alarm Silence button. The alarm tone ceases for 120 seconds (default). ■ ■ Adjust the alarm volume. Adjust the pulse beep volume. ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual NOTE: Turn the oximeter off between patients so that it can re-calibrate in order to interpret new physiological data. 19. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off [3 seconds in the Home Mode]. 18. 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. 17. Monitor the patient. 16. Verify the sensor is applied correctly and that the measured data is appropriate, see Section 4, Successful SpO2 Monitoring. Adjust the alarm limits. ■ 14. To begin patient monitoring: Create an alarm condition by lowering the SpO2 or pulse rate high alarm limits beyond the patient readings. ■ 13. Verify parameter-violation alarm silence operation. NOTE: “No sensor” and “sensor off” will only generate an alarm if the Rad-8 was actively monitoring a patient when the sensor was disconnected. “Sensor off” indicator illuminates. ■ 12. Verify the sensor alarms are functional by removing the sensor from the sensor site. An alarm tone sounds. ■ 11. Verify that the patient alarms are functional by setting the high and low SpO2 and pulse rate alarm limits beyond the patient readings. operation Set to Off FastSat Set to Standard Home Mode† Normal/Invert Alarm and Signal IQ/ Low Signal IQ/ Alarm Alarm, Off/On Philips/ASCII 1/ASCII 2 0, 5, or 10 seconds On/Off or muted with reminder Standard/Sleep/Home Levels 1 thru 3 30, 60, 90, or 120 seconds Off, Levels 1 thru 3 Levels 1 thru 4 NOTE: Defaults to APOD and Normal only. MAX sensitivity will default to Normal after a power cycle. Max/Normal/APOD Off/On Off/On 2, 4, 8, 10, 12, 14, or 16 seconds 25 to 235 BPM 30 to 240 BPM 1 to 100% 2 to 100% CONFIGURABLE SETTING Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual * CAUTION: ALARMS ARE DISABLED IN THIS MODE. † If the unit is connected to a RadNet system, there will be no communication with RadNet in this mode. Set to Normal Nurse Call Polarity Set to Alarm Interface Alarm Set to Alarm Set to ASCII 2 Serial out Nurse Call Type Set to level 5 Alarm Delay Set to alarms active Set to Standard Audible Alarm off Set to level 1 Sleep Study Mode*† Set to 120 seconds Set to level 2 Set to level 2 Alarm Volume Alarm Silence Time Pulse tone volume Display brightness Set to Norm setting Set to Off Trauma Sensitivity Set to 8 seconds Set to 50 BPM Pulse rate low alarm limit Averaging Time Set to 140 BPM Set to 90% Set to Off FACTORY DEFAULT SETTING Pulse rate high alarm limit SpO2 low alarm limit SpO2 high alarm limit OPTION The following table outlines the default values that the Rad-8 reverts to after a power cycle if not changed by the user: FACTORY DEFAULT SETTINGS The Rad-8 oximeters store two types of default values: those that the device automatically reverts to after a power cycle, and those that can be changed by the user which will be remembered after a power cycle. operation 4 4-3 4-4 4 Place the sensor on a site that has unrestricted blood flow. Do not select a site near potential electrical interference (electrosurgical unit, for example). Read the sensor Directions for Use for proper sensor application. ■ ■ ■ 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 USE ADDITIONAL TAPE TO SECURE SENSOR TO PATIENT. ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 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 CONNEC TORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE (UNLESS OTHERWISE INDICATED ON THE SENSOR DIRECTIONS FOR USE). SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS. ■ CAUTIONS Tissue damage can be caused by incorrect application or use of an LNOP, LNOPv or LNCS 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. Use only Masimo oximetry sensors for SpO2 measurements. MASIMO SENSORS Before use, carefully read the LNOP, LNOPv and LNCS sensor Directions for Use. 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 a good feeling for 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 oximeter and reduce the measured variations of SpO2 and PR. Place the sensor on a site that is not too thick, has sufficient perfusion and provides proper alignment of the LED’s and photodetector. ■ The following general points will aid in ensuring oximetry monitoring success. Successful SpO2 monitoring operation Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Rad-8 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 be additive to the pulse rate displayed on the pulse oximeter. operation 4 4-5 4-6 4 Check the sensor and ensure proper sensor application. The sensor must be well secured to the site for the Rad-8 to maintain accurate readings. Also, misalignment of the sensor’s emitter and detector can result in smaller signals. Determine if an extreme change in the patient’s physiology and blood flow at 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 a spell of Raynaud’s syndrome.) With neonates or infants, check that the peripheral blood flow to the sensor site is not interrupted. Interruption, for example, as may occur while lifting or crossing their legs, during a diaper change. ■ ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual After performing the above, if the “Low Signal IQ” indication occurs frequently or continuously, obtaining an arterial blood specimen for CO-Oximetry analysis may be considered to verify the oxygen saturation value. Assess the patient. ■ The height of the Signal IQ bar indicates the quality of the measured signal. A high vertical bar indicates that the SpO2 measurement is based on a good quality signal. A small vertical bar 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. A “Low Signal IQ” is indicated by a bar height of two bars or less and the bars turn red. When this occurs, proceed with caution and do the following: The Signal IQ is shown as a “bouncing bar” indicator, where the peak of the bar coincides with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Rad-8 locates the arterial pulsation. The pulse tone (when enabled) coincides with the peak of the Signal IQ bar. As saturation increases or decreases, the pulse tone will ascend or descend accordingly, for each 1% change in saturation. SIGNAL IQ AND PULSE BAR The Rad-8 display provides a visual indicator of the plethysmogram 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-8 is called the Signal IQ. The Signal IQ can be used to identify the occurrence of a patient’s pulse and the associated signal quality of the measurement. operation Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE OXIMETER FOR PROPER FUNCTIONING. If possible, ensure that the sensor is placed in a location with low ambient light. Although the Rad-8 pulse oximeter integrated with Masimo SET technology has significant immunity to ambient light, excessive ambient light may cause readings to be incorrect. If possible, remove electrical noise sources such as electrosurgical units or other electrical/electronic equipment. ■ ■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (1030% methyl salicylate and 2-10% menthol) for 20-30 seconds. Strong vasodilator creams, such as nitroglycerin paste, are not recommended. ■ If artificial nails or excessive fingernail polish are present, select another site or remove the polish/artificial nails. Select a site where the distance between the emitter and photodetector is minimized. ■ ■ Make sure the emitter and photodetector are aligned directly opposite each other. ■ ACTIONS TO BE TAKEN If the SpO2 readings show significant differences, do the following: 1 Severinghaus JW, Spellman MJ. pulse oximeter Failure Thresholds in Hypotension and Vasoconstriction. Anesthesiology 1990; 73:532-537 CAUTION: IF THE LOW PERFUSION INDICATION IS FREQUENTLY DISPLAYED, FIND A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS. It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation1. 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.) LOW PERFUSION The Rad-8 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). operation 4 4-7 4-8 4 BUTTON Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual In the setup/menu system, the Up and Down Arrow keys select among the options for each setting and allows navigation through the menu(s). During normal patient monitoring the Up and Down Arrow keys control the Pulse Tone volume. At the lowest setting, the pulse tone is muted. A lowpitch tone indicates the highest or lowest setting has been reached. If a low battery alarm occurs during patient monitoring, pressing the Alarm Silence button will silence the audible alarm for 120 seconds (default). Pressing this button will acknowledge and permanently silence a ‘sensor-off’ and ‘no-sensor’ audible alarm except in the Home and Sleep modes. In Sleep mode, all alarms are disabled. It will also permanently silence a low battery audible alarm if the Rad-8 is not monitoring a patient. Alarm Silence. Pressing this button one time will silence the alarm for 120 seconds (default). A second press will return the unit to standard alarm monitoring. Allows movement from one menu option to the next. Enters the Rad-8 setup/menu system. See Section 4, Setup menu. Power on/off. Press to turn Rad-8 on. Press-and-hold for 2 seconds to turn Rad-8 off. FUNCTION RAD-8 FRONT PANEL CONTROL OPERATION The following sections describe the function of the Rad-8 front panel controls during normal patient monitoring. During normal operation, the Rad-8 Display shows oxygen saturation (as % SpO2) and Pulse Rate (in beats per minute). Normal patient monitoring If a low battery condition occurs, immediately discontinue patient monitoring and plug the monitor into AC power. If a low battery condition occurs while not monitoring a patient, pressing the Alarm Silence Button will suspend the audible alarm until the power is cycled or patient monitoring begins. A visual low battery indicator will continue to blink while audible alarms are silenced. LOW BATTERY AUDIBLE ALARM If a low battery condition occurs during patient monitoring, a low priority alarm will sound, and can be silenced for 120 seconds (default) by pressing the Alarm Silence Button. Refer to Setup Menu Level 1 in this section to change setting. operation SETTING Averaging. The signal averaging time of this device can be set to: 2†, 4†, 8, 10, 12, 14 or 16 seconds (Default 8 seconds) Alarm Delay *0, 5, 10 seconds (Default 5 seconds) Alarm on / off Alarm muted with reminder (Default on) Alarm Silence Duration 30, 60, 90 and 120 seconds (Default 120 seconds) Alarm Volume NOTE: The parameter is set/ selected when Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. is automatically enabled in 2 and 4 second averaging. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual †FastSat occur. Alarm delay applies only when the saturation limit is exceed by less than 5%. *Alarm delay allows the user to adjust the time in which the audible status indicator will 1X BUTTON SETUP MENU LEVEL 1 – ALARM FEATURES AND SENSITIVITY. Push the Mode/Enter button to enter menu level 1. NOTE: The Rad-8 will automatically ‘time out’ of the setup menu after 10 seconds with no key presses. MENU NAVIGATION The Rad-8 set-up and configuration options are accessed through the menu system. The Mode/Enter key is used to enter the menu system and to move through the different menu levels. Within each level of the system, the Next key is used to move from one option to the next. The Up and Down arrow keys are used to select values within each option. The parameter is set/selected when either the Mode/Enter or Next keys are pressed. This section gives an overview of the Rad-8 menu selections available. To navigate through the menus, use the Mode/Enter, Next, Up and Down keys located on the front panel of the oximeter. The following sub-sections describe each menu item in more detail. The oximeter has options that allow user configuration to suit specific needs. Setup menu operation 4 4-9 4-10 4 SETTING (First press Up arrow two times and then press Mode/Enter. Password: next button, up arrow, down arrow, next button) Save User Identified Default Settings Restore Factory Default Settings Yes / No Button Volume (Off, 3 Levels) NOTE: Active LED indicators are effected while adjusting this setting LED Display Brightness (4 levels) NOTE: The parameter is set/selected when Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. Clear Trend Yes / No SETTING NOTE: The parameter is set/selected when Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual NOTE: It is recommended that you clear the trend prior to performing a new patient data collection procedure. The Rad-8 only stores data in the trend memory while the device is turned on, and the trend data remains in memory until the memory fills up or cleared by the user. 3X BUTTONS Push the Mode/Enter button again to enter menu level 3. SETUP MENU LEVEL 3 - CLEAR TREND NOTE: User default settings can be changed for specific patient environments. 2X BUTTONS SETUP MENU LEVEL 2 – BUTTON VOLUME, LED BRIGHTNESS AND FACTORY DEFAULT SETTINGS Push the Mode/Enter button again to enter menu level 2. operation Set Minute Set Hour Set Day Set Month Set Year Select Clock SETTING SETTING Alarm Low Signal IQ Alarm and Signal IQ Nurse Call Polarity-Normal / Invert Nurse Call Type Alarm Monitor Interface On / Off Serial out - Philips, ASCII 1, ASCII 2 Software Version Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual NOTE: See tables below for further description of features. 5X BUTTONS NOTE: The parameter is set/selected when Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. NOTE: The parameter is set/selected when Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. SETUP MENU LEVEL 5 - OUTPUT Push the Mode/Enter button again to enter menu level 5. 4X BUTTONS SETUP MENU LEVEL 4 - SET DATE AND TIME Push the Mode/Enter button again to enter menu level 4. operation 4-11 4 4-12 4 DESCRIPTION SERIAL MENU ITEMS The Rad-8 pulse 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-8. 6. With a properly configured RadNet Interface Module, the Rad-8 will automatically display the SpO2 and Pulse Rate parameters on the screen at the RadNet Central Station. 5. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Pressing a sixth time returns the Rad-8 to patient monitoring in the Saturation/ Pulse Rate Mode. Additionally, the Rad-8 will automatically return to patient monitoring display from any menu level/setting after 10 seconds with no key presses. Connect the other end of the serial cable to the RadLink Bedside Radio serial connector. Complete setup in accordance with the RadLink Operator's manual. 3. 4. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Connect one end of the serial cable to the Serial Output connector on the back of the Rad-8. 2. RADLINK SETUP 1. Select the ASCII 1 selection from the Serial options on the Rad-8 pulse oximeter. The Rad-8 pulse oximeter can be set up to audibly indicate all patient alarms while communicating with the RadNet Interface module. Turn the RadNet Interface Module on. A proper connection is shown by the RadNet Interface Module's Online LED being solid. 4. Normal Standard polarity. See section 7, Analog output / nurse call specifications. 6. Connect the other end of the serial cable to the RadNet Interface Module connector. 3. Invert This setting reverses the Normally Open and Normally closed contacts. See section 7, Analog output / nurse call specifications. Connect one end of the serial cable to the Serial Output connector on the back of the Rad-8. 2. RADNET SETUP 1. Select the ASCII 2 selection from the Serial options on the Rad-8 pulse oximeter. The SpO2 and pulse rate values will automatically appear on the HP/Agilent monitor. 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 Operator’s manual for complete instructions. 4. Connect the other end of the VueLink cable to the VueLink module and insert the module into the Philips/Agilent monitor rack. 3. 5. Connect one end of the VueLink cable to the Serial Output connector on the back of the Rad-8. 2. PHILIPS VUELINK SETUP 1. Select the Philips VueLink selection from the Output menu on the Rad-8. After selecting, choose the preferred settings by stepping through menu options. Refer to Section 5, Output. System interfaces operation Alarm & Low Signal IQ The nurse call output will be activated based on alarm and Low Signal IQ events. Low Signal IQ The nurse call output will be activated based on Low Signal IQ events. CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS THE RAD-8 PULSE OXIMETER IS CONNECTED TO THE AC MAIN POWER SUPPLY. NURSE CALL POLARITY NURSE CALL TYPE The following serial output modes are supported. All serial output is RS232 based. See the interface specifications in Section 7, Specifications. ASCII 1 ASCII text data is sent to the serial interface at one-second intervals. The ASCII text includes: date and time stamp, SpO2 pulse rate, PI, and alarm and exception values. All text is single line followed by a line feed character and a carriage return. ASCII 2 ASCII text data is sent to the serial interface following a query from the connecting computer. RadNet data output is in this format. Philips VUELINK SpO2, pulse rate and plethysmographic waveform data are sent in Philips VueLink format to the serial port. Alarms The nurse call output will be activated based on alarm events. DESCRIPTION MENU ITEMS OUTPUT DESCRIPTION operation 4-13 4 4-14 4 to toggle to to toggle to Sleep Mode* - (SLP) Press Home Mode - (Hnn) Press Enter Standard Mode - (Std) SETTING NOTE: Only available Indicators are illuminated while adjusting setting NOTE: The parameter is set/selected when Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual CAUTION: ALARMS ARE DISABLED IN THIS MODE. NOTE: If the unit is connected to a RadNet system, there will be no communication with RadNet in Home and Sleep mode. SLEEP MODE OPERATION The Rad-8 can be placed into the Sleep Mode to allow the unit to capture normal and abnormal patient data without triggering the alarms. This mode will blank out the unit display with the exception of the Battery Level Indicator and the Alarm Silenced Indicator and disable the alarms even after a power cycle. However, any single key press will bring the display back for 10 seconds. Upon power up, the SLP mode will be displayed along with a 10 second display of parameter settings. The Mode Enter and Next key held simultaneously for 3 seconds (select next (STD), Mode Enter) will put it back into the special menu to exit. HOME MODE OPERATION The Rad-8 can be placed into the Home Mode to protect unqualified users from changing the Rad-8 alarm settings and operation. Only the following menu and front panel functions are available: display brightness (press + to adjust brightness), pulse beep volume adjustment and alarm suspend. 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 Hmm mode will be displayed along with a 10 second display of parameters. To turn the unit off the power key must be depressed and held for 3 seconds. The Mode Enter and Next key held simultaneously for 3 second will put it back into the special menu to select a different mode. *CAUTION: ALARMS ARE DISABLED IN THIS MODE. Simultaneous for 3 seconds + BUTTONS This section gives an overview of the Rad-8 special menu selections available. To navigate through the menus, use the Mode/Enter, Next, Up and Down keys located on the front panel of the oximeter. The following sub-sections describe each menu item in more detail. The oximeter has options that allow user configuration to suit specific needs. SPECIAL MENU – STANDARD, HOME AND SLEEP MODE Turn instrument on, then push and hold the Mode/Enter and Next buttons simultaneously for 3 seconds to enter the special menu levels. Special Menu operation Pulse Rate Low Alarm Limit Pulse Rate High Alarm Limit SpO2 Low Alarm Limit SpO2 High Alarm Limit SETTINGS NOTE: The parameter is set/selected when the Mode Enter or Next are pressed. Use Up or Down Arrow Keys to adjust parameter to desired setting. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual TRENDCOM UTILITY OPERATION 1. Turn Rad-8 off if not already off. 2. Connect serial cable to Rad-8 and other end to a com port on the PC. 3. Turn the Rad-8 on. 4. Start the TrendCom utility on the PC. 5. Select Rad-8 from the first pull-down menu. 6. Select the appropriate com port number from the second pull-down menu, if necessary. 7. Select the Output Delimeter Option (Tab, Comma or Space). 8. Select the RETRIEVE TREND button on the TrendCom utility. Select the desired location and assign a file name for the trend file. Select SAVE. 9. The Rad-8 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 in formation, all normal Rad-8 functions are unavailable and the keypad is locked, except for the power button. TRENDCOM UTILITY INSTALLATION Copy the TrendCom utility from the TrendCom CD onto a PC running MS-Windows. 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 delimeter option. Trend data is stored in non-volatile memory, so it is not erased when the unit is shut off. A serial cable is required to connect the Rad-8 to a PC. Patient monitoring is not possible while trend memory is being transferred to a PC. INTRODUCTION The Rad-8 can store up to 72 hours of SpO2, pulse rate, and perfusion index trend data captured at 2 second intervals. The trend data can then be transferred to a PC for evaluation. Trend setup and use BUTTONS SPECIAL MENU – SpO2 AND BPM ALARM LIMITS operation 4-15 4 4-16 4 When trend data transfer is complete, close TrendCom and disconnect the Rad-8 from the serial cable. HH:MM:SS 001 to 100, or "---" meaning parameter not available 001 to 240, or "---" meaning parameter not available 00.00 to 20.00 Time SpO2 Pulse Rate Perfusion Index 07/21/04 07/21/04 07/21/04 07/21/04 07/21/04 07/21/04 07/21/04 07/21/04 09:56:08 09:56:10 09:56:12 09:56:14 09:56:16 09:56:18 09:56:20 09:56:22 SpO2=000 SpO2=000 SpO2=097 SpO2=096 SpO2=098 SpO2=000 SpO2=000 SpO2=096 PI=00.00 PI=00.00 PI=04.69 PI=02.28 PI=03.64 PI=00.00 PI=00.00 PI=02.68 EXC=820:OffPat,SET EXC=828:Search,OffPat,SET EXC=800:SET EXC=C00:LowSigIQ,SET EXC=800:SET EXC=800:SET EXC=820:OffPat,SET EXC=800:SET Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual PR=000 PR=000 PR=069 PR=074 PR=078 PR=000 PR=000 PR=078 000 = 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 is full SET mode. It requires a SET sensor and needs to acquire some clean data for this flag to be set SAMPLE TREND OUTPUT Exception Messages MM\DD\YY Date The exceptions are displayed as a 3 digit, ASCII encoded, hexadecimal value. The binary bits of the hexadecimal value are encoded as follows: SPECIFICATION Low battery High saturation (SpO2 range 2-100%) Sensor off and no sensor High pulse rate (pulse rate range 30-240 bpm) Low pulse rate (pulse rate range 25-235 bpm) System failures Low saturation (SpO2 range 1-100%) PARAMETER Out-of-limit parameter will flash ■ Audible and visual ALARM TYPE Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual “no sensor” and “sensor off” will only generate an alarm condition after a pulse has been found. Visual Alarm Indicator Audible alarm tone ■ ■ An alarm condition is indicated by: Alarm indication Low High 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. PARAMETER ALARM PRIORITY Two levels of alarm priority are implemented: high and low priority. The following table outlines the alarm priority specifications. Audible alarms may be silenced, without affecting the operation of visual alarms. The Rad-8 visually and audibly indicates alarm conditions that the system detects. Alarm identification alarms and messages To erase (clear) the trend memory, see section 4, menu navigation, “clear trend” and follow the instructions. The Rad-8 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-8 off will not erase the trend data. ERASING TREND MEMORY NOTE: Contact USB to serial port adapter manufacturer for assistance or support. 11. Turn the Rad-8 off to exit the trend download mode. 10 operation 5 5-1 5-2 5 The SpO2 high alarm limit can be set anywhere between 2% and 99%, with a 1% step size. In the “----” (off) setting, the SpO2 High Limit alarm is disabled. SpO2 High Limit NOTE: 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. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 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 they will be set back to the factory defaults. NOTE: Pressing and holding down the up and down buttons allow for the rapid scrolling of changing SpO2 and BPM alarm limits. Pulse Rate Low Limit (BPM) The pulse rate high alarm limit can be set anywhere between 30 BPM and 240 BPM, with a 5 BPM step size. Pulse Rate High Limit (BPM) The pulse rate low alarm limit can be set anywhere between 25 BPM and 235 BPM, with a 5 BPM step size. NOTE: 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. SpO2 Low Limit The SpO2 low alarm limit can be set anywhere between 1% and 99%, with a 1% step size. RANGE SETTING An audible alarm and a flashing alarm status indicator will occur when an alarm limit is exceeded for greater than five seconds (See section 4, Alarm Features and Sensitivity to adjust this setting). It is best that the operator be within a minimum of 10 feet from the unit. Directions for alarm suspension are indicated below. When a sensor is not connected to a patient the “no sensor” indicator will illuminate. When a sensor is not connected to its cable, “sensor off” indicator will illuminate. An audible alarm will accompany the visual indicator unless the oximeter has been set to Alarm Suspend Mode. CAUTION: TO ENSURE THAT ALARM LIMITS ARE APPROPRIATE FOR THE PATIENT BEING MONITORED, CHECK THE LIMITS EACH TIME THE PULSE OXIMETER IS USED. Alarm limits alarms and messages Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Should the alarm condition be created by a low battery condition, plug the unit into AC power immediately. While not monitoring a patient, acknowledging an alarm condition by pressing the Alarm Silence Button (one time) will permanently silence the alarm tone, and the Alarm Silenced Indicator will remain illuminated until the power is cycled or patient monitoring begins. While in the Home Mode and not monitoring a patient, the alarm will be suspended for 120 seconds (default). While monitoring a patient, acknowledging an alarm condition by pressing the Alarm Silence Button (one time) will silence the alarm tone for 120 seconds (default) and the Alarm Silenced Indicator will flash. Pressing the Alarm Silence Button a second time (while the Alarm Silenced Indicator is still flashing) will activate alarms and alarm silenced indicator is off. ALARM SILENCED INDICATOR The Alarm Silenced Indicator provides visual feedback when illuminated, the Rad-8 audible alarms are muted. Push Twice - Return to Audible Alarm Active. Push Once – Alarm is suspended for 120 seconds and Alarm Suspended Indicator flashes (See section 4 “Alarm features and sensitivity” to adjust alarm suspension time period). Power-On – Alarms are active and Alarm Suspended Indicator is off. ALARM SILENCE Audible alarms may be suspended, while visual alarms may not. With the exception of Sleep Mode, there are two audible alarm suspension settings, all controlled by the Alarm Suspend Button. Repeated pressing of the Alarm Suspend button will cycle though two alarm suspend options. alarms and messages 5 5-3 5-4 5 Low Signal IQ Low Perfusion Saturation limit alarm Pulse Rate limit alarm PULSE BAR TURNS RED (Bottom two LEDs only.) PERFUSION BAR TURNS RED (Bottom two LEDs only.) SpO2 NUMBER FLASHES PULSE RATE NUMBER FLASHES Connect appropriate cable Ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Unrecognized sensor Interference detected Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Replace sensor There are several error codes, all error codes require return of the unit to an authorized service center for repair. See Section 9, Service and Repair. Return for service Re-set alarm limits if indicated. Assess /address patient condition. Re-set alarm limits if indicated Assess /address patient condition. NOTE: Masimo recommends using an adhesive sensor whenever low perfusion is expected or evident. 3. Move sensor to better perfused site. 2. Attempt to warm patient. 1. Rule out occlusion of blood flow. 2. Verify placement of sensor. 1. Rule out occlusion of blood flow. Wait for found pulse. (This Search should occur whenever a sensor is first applied to a patient). SOLUTION Defective sensor System Fault Pulse Search TYPE LEDS FLASH HORIZONTAL BARS DISPLAY Message conditions for the Rad-8 follow: MESSAGES The Rad-8 will indicate other data or system errors. alarms and messages TYPE Internal Failure Alarm Suspend Enabled Pulse tone set to “mute” Internal Failure Low battery/ not plugged into AC power supply SOLUTION Use auxillary power down method by pressing and holding sensitivity and Alarm Suspend buttons simultaneously. Return for service. Inspect Alarm Suspend Indicator. See Section 4, Alarm Suspend. Press Alarm Suspend button until Alarm Suspend Indicator is no longer illuminated or flashing. Press Up Arrow (Rad-8) or Alarm Volume Adjust (Rad-8). Unit requires service. Press the Alarm Silence button. If alarm continues to sound, power down unit. If the power button does not turn the unit off, press and hold the sensitivity and alarm suspend buttons simultaneously. Return the unit for service. Check / plug into AC power supply. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual BUTTONS DON’T WORK WHEN PRESSED NO SPEAKER TONE CONTINUOUS SPEAKER TONE UNIT DOES NOT POWER ON DISPLAY The following chart describes what to do if the Rad-8 system does not operate properly or fails. Troubleshooting troubleshooting 6 6-1 1-100% Sealed lead acid 8 hours4 8 hours 100-240 VAC, 50-60 Hz 15 VA max. 1% 1 bpm ±3 digits ±5 digits ±3 digits 25-240 bpm ±2 digits ±3 digits ±3 digits ±3 digits ±2 digits ±3 digits 70% to 100% <1 second delay 0.02% - 20% 25-240 beats per minute (bpm) 41°F to 104°F (5°C to 40°C) -40°F to 158°F (-40°C to +70°C)5 5% to 95%, non-condensing 500 mbar to 1060 mbar pressure, -1000 ft to 18,000 ft (-304 m to 5,486 m) Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Operating Altitude: Operating Temperature: Transportation/Storage Temperature: Operating/Storage Humidity: ENVIRONMENTAL AC Power requirements: Power consumption: Battery Type: Capacity: Charging time: ELECTRICAL Saturation No Motion1 Adults, Pediatrics Neonate Motion2 Adults1 , Pediatrics1 Neonate Low Perfusion3 Adults, Pediatrics Neonate Pulse Rate Accuracy Pulse rate: No Motion1 Adults, Pediatrics, Neonate Motion2 Adults, Pediatrics, Neonate Low Perfusion3 Adults, Pediatrics, Neonates Resolution Saturation (%SpO2) Pulse Rate (bpm) ACCURACY Response time: Perfusion: Pulse Rate: Measurement Range SpO2: PERFORMANCE Rad-8 specifications specifications 7 7-1 7-2 7 Normal, Maximum and APOD 2, 4, 8,10, 12, 14 or 16 seconds5 EN60601-1-2, Class B Continuous Type BF-Applied Part Class 1 (on AC power), Internally powered (on battery power) IEC 60601-1/ UL 60601-1/IEC 60601-1-1 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 5 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. 4 This represents approximate run time at lowest indicator brightness and pulse tone turned off using a fully charged battery. 3 Masimo SET technology 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 a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population. 2 Masimo SET technology with LNOP Adt sensors has 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 4Hz 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 which encompasses 68% of the population. The saturation accuracy of the neonatal sensors were validated on adult male and female volunteers with light to dark skin pigmentation and 1% was added to account for the properties of fetal hemoglobin. 1 Masimo SET technology with LNOP Adt/ Neo sensors has 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 which encompasses 68% of the population. The saturation accuracy of the neonatal sensors were validated on adult male and female volunteers with light to dark skin pigmentation and 1% was added to account for the properties of fetal hemoglobin. Rad-8 Mode of Operation: Degree of Protection-Patient Cable: Type of Protection Equipment Classification: EMC Compliance: Compliance 1 second LED Type: Display update rate LED %SpO2, pulse rate, alarm status, alarm silenced status, AC power, Signal IQ / pleth bar, perfusion index bar, battery status, no sensor, sensor off 80 dB max APOD, Norm, Max, FastSat, Trauma Data display: Display/Indicators Alarm Volume: (SpO2 range 1-99%, --- off, pulse rate range 25-240 bpm) 800 Hz tone, 5 pulse burst, pulse spacing: 0.250s, High Priority: 0.250s, 0.500s, 0.250s, repeat time:10s Low Priority: 500 Hz tone, 3 pulse, repeat time: 5s Audible and visual alarms for high and low saturation and pulse rate Sensor condition, system failure and low battery alarms Alarms Rad-8 Sensitivity: Rad-8 Averaging mode: Rad-8 Modes None Female DB-9 HANDSHAKING CONNECTOR TYPE SIGNAL NAME No Connection No Connection No Connection No Connection 6 7 8 9 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Signal Ground Reference for COM signals No Connection Transmit data – RS-232 ±9 V (±5 Vmin) Receive data – RS-232 ±9 V (±5 Vmin) No Connection 5 4 3 2 1 PIN The pin-outs for the RS-232 connector are shown in the following table: 1 start, 1 stop BITS None 8 PARITY 9600 Baud bi-directional NUMBER OF BITS PER CHARACTER SETTING BAUD RATE PARAMETER SERIAL INTERFACE SETUP To interface with the Rad-8 serial port, set the following communication parameters on the interfacing serial device: NOTE: Trend data packets are collected at 2 second intervals. Each data packet contains: the date, time, SpO2, pulse rate, perfusion index and alarm and exception values (in ASCII format). The Rad-8 pulse oximeter by default always outputs ASCII2 text data through the serial port, unless the user selects a different output mode in the Output menu. To interface with the Rad-8 and receive serial text data, simply connect a serial interface cable to the serial output connector located on the back of the Rad-8. The digital interface for serial communication is based on the standard RS-232 protocol. 2.1 lbs. = .908 Kg. = 32 oz 8.2” x 6.0” x 3.0” (20.8 cm x 15.2cm x 7.6 cm) Dimensions: Weight: Serial interface specifications specifications PHYSICAL CHARACTERISTICS specifications 7 7-3 7-4 7 36 VDC or 24 VAC peak MAX VOLTAGE Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual WARNING: THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE ALARMS ARE SILENCED WHILE THE NURSE CALL SETTING IN THE OUTPUT MENU IS SET TO “ALARMS”. SPECIFICATION PARAMETER The nurse call relays have the following electrical specification per switch: NURSE CALL The nurse call feature on the Rad-8 pulse 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 features are accessible via the 1/4” round female connector on the back of the unit. Nurse call specifications WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE RS-232 SERIAL PORT MUST BE IEC-60950 COMPLIANT. SERIAL PRINTER SETUP To print the SpO2 and pulse rate data in ASCII1 format on a serial printer, simply connect the laser printer to the serial port and set output mode to ASCII1. Once serial communication is established, the Rad-8 automatically will start printing the ASCII1 text data. specifications 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, OR ETHYLENE OXIDE. ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS. VERIFY THE COMPATIBILIY OF THE MONITOR, CABLE AND SENSOR BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT. DO NOT USE ADDITIONAL TAPE TO WRAP SENSOR. ■ ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 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 an SpO2 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. SELECTING A MASIMO SET SENSOR When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the available sensor sites, and the duration of monitoring. For more information refer to the following table or contact your Sales Representative. Use only Masimo SET 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. 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, OR ETHYLENE OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS. ■ CAUTIONS: Tissue damage can be caused by incorrect application or use of a Masimo 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. Use only Masimo oximetry sensors and cables for SpO2 measurements. Other oxygen transducers or sensors may cause improper Rad-8 pulse oximeter performance. Before use of any sensor or cable, carefully read the sensor or cable Directions for Use. Masimo SpO2 sensors This section covers the use and cleaning of Masimo SET sensors and Masimo SET patient cables. Introduction sensors & patient cables 8 8-1 8-2 8 > 30 kg > 30 kg SENSOR LNOP DCSC LNOP DC-12 ± 2% ± 3 bpm > 30 kg > 30 kg LNOP TC-I LNOP DC-195 LNOP TF-I ± 2% ± 2% ± 3.5% ± 2% ± 2% N/A ± 3% N/A ± 3% ± 3% Saturation Accuracy No Motion Motion ± 2% ± 3% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm N/A ± 5 bpm N/A ± 5 bpm ± 5 bpm Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm ® ± 3% ± 2% < 10 kg < 1 kg < 3 kg > 40 kg LNOP Neo LNOP NeoPt < 1 kg 3 - 20 kg LNOP NeoPt-L LNOP Inf-L LNOP Neo-L ± 3% 10 - 50 kg LNOP Pdtx ± 2% ± 3% ± 3% ± 2% ± 2% ± 2% > 30 kg 10 - 50 kg LNOP Pdt ± 2% ± 2% ± 3.5% N/A ± 2% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm ± 2% ± 3% ± 2% ± 3% ± 3% ± 3% ± 2% ± 2% ± 2% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm N/A ± 3 bpm Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual ± 3% ± 3% ± 3% ± 3% ± 3% ± 3% ± 3% ± 3% ± 3% Saturation Accuracy No Motion Motion ± 2% ± 3% LNOP Adtx > 30 kg Weight Range LNOP Adt SENSOR LNOP ADHESIVE SENSORS (LNOP sensors must be used in conjunction with PC cables) ± 3 bpm Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm ± 2% Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm NOTE: The LNOP TF-I and TC-I sensors were not validated under motion conditions. > 1 kg > 30 kg LNOP YI > 30 kg 10 - 50 kg LNOP DCIP Weight Range LNOP DCI SENSOR ± 5 bpm Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm (LNOP sensors must be used in conjunction with PC cables) ± 3% Saturation Accuracy No Motion Motion ± 2% ± 3% LNOP REUSABLE SENSORS ® Weight Range LNOP DIRECT CONNECT REUSEABLE SENSORS ® 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. sensors & patient cables 3 - 20 kg < 3 kg ± 2% ± 3% ± 3% ± 3% N/A 80 - 100% ± 3% N/A N/A 60 - 80% ± 4% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 5 bpm ± 5 bpm N/A N/A N/A Saturation Accuracy Pulse Rate Accuracy No Motion Motion No Motion Motion 2.5 - 30 kg 70 - 100% ± 3.3% Weight Range < 3 kg > 30 kg LNOPv Ad ± 2% ± 3% ± 3 bpm ± 3 bpm > 1 kg > 30 kg > 30 kg ± 2% ± 2% ± 3.5% ± 2% ± 3% N/A N/A ± 3% Saturation Accuracy No Motion Motion ± 2% ± 3% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 5 bpm N/A N/A ± 5 bpm Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm TM ± 2% > 40 kg ± 3% ± 3% ± 3% ± 3% ± 3% ± 3% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual LNCS NeoPt-L < 1 kg ± 3% < 3 kg LNCS Neo-L ± 2% 3 - 20 kg LNCS Inf-L ± 2% > 30 kg 10 - 50 kg Saturation Accuracy No Motion Motion ± 2% ± 3% LNCS Pdtx Weight Range LNCS Adtx SENSOR (LNCS sensors must be used in conjunction with LNC cables) LNCS ADHESIVE SENSORS ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm N/A ± 2% ± 3.5% ± 2% ± 3% ± 2% ± 3% ± 2% ± 2% ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm N/A ± 3 bpm ± 3 bpm ± 3 bpm Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm ± 2% ± 3% Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm ± 2% ± 3% ± 3% ± 3% ± 3% Low Perfusion Accuracy Saturation Pulse Rate NOTE: The LNCS TF-I and TC-I sensors were not validated under motion conditions. LNCS YI LNCS TF-I LNCS TC-I > 30 kg 10 - 50 kg LNCS DCIP Weight Range LNCS DCI SENSOR ± 5 bpm ± 5 bpm Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm (LNCS sensors must be used in conjunction with LNC cables) ± 3% ± 3% Saturation Accuracy No Motion Motion ± 2% ± 3% LNCS REUSABLE SENSORS TM 3 - 20 kg LNOPv Ne Weight Range LNOPv In SENSOR LNOPv ADHESIVE SENSORS (LNOPv sensors must be used in conjunction with PC cables) TM LNOP Newborn Inf LNOP Newborn Neo LNOP Blue SENSOR LNOP SPECIALTY SENSORS (LNOP sensors must be used in conjunction with PC cables) ® sensors & patient cables 8 8-3 8-4 8 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual ■ Allow the cable to dry before returning it to operation. ■ Wipe clean with a 70% isopropyl alcohol pad. ■ Disconnect the cable from the monitor. ■ Remove the cable from the sensor. CLEANING AND REUSE OF MASIMO SET PATIENT CABLES Patient cables can be cleaned per the following procedure: Reusable patient cables of various lengths are available. Only use appropriate Masimo oximetry patient cables for SpO2 measurements. Other patient cables may cause improper Rad-8 pulse oximeter performance. Masimo SET patient cables ■ DO NOT SOAK OR IMMERSE THE SENSOR IN ANY LIQUID SOLUTION. DO NOT STERILIZE ANY MASIMO SENSOR BY IRRADIATION, STEAM, OR ETHYLENE OXIDE. ■ DO NOT REPROCESS ANY SINGLE USE SENSORS. CAUTIONS: WARNING: TO AVOID CROSS CONTAMINATION ONLY USE MASIMO SINGLE USE SENSORS ON THE SAME PATIENT. 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. ■ The adhesive can be partially rejuvenated by wiping with a 70% isopropyl alcohol wipe and allowing the sensor to thoroughly air dry prior to replacement on the patient. 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. ■ Allow the sensor to air dry before returning it to operation. ■ Wipe the entire sensor clean with a 70% isopropyl alcohol pad. ■ Disconnect the sensor from the monitor. ■ Remove the sensor from the patient. CLEANING AND REUSE OF MASIMO SENSORS Reusable sensors can be cleaned per the following procedure: sensors & patient cables Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual ■ DO NOT REPROCESS ANY MASIMO SET PATIENT CABLES. ■ DO NOT SOAK OR IMMERSE PATIENT CABLES IN ANY LIQUID SOLUTION. DO NOT STERILIZE PATIENT CABLES BY IRRADIATION, STEAM, OR ETHYLENE OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO PATIENT CABLES. ■ CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF PATIENT ENTANGLEMENT OR STRANGULATION. CAUTIONS: sensors & patient cables 8 8-5 Ammonium Chloride Wipe 10% Chlorine bleach in H2O 70% Isopropyl alcohol ■ ■ ■ DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID. USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS. DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE 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 ATTACK THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT. ■ ■ ■ ■ Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Refer to Section 8, Cleaning and Reuse of Masimo Sensors for cleaning instructions of the sensor. DO NOT AUTOCLAVE, PRESSURE STERILIZE, OR GAS STERILIZE THIS OXIMETER. ■ CAUTIONS: Glutaraldehyde Solution ■ To clean the outer surface of the oximeter, the following solutions may be used to wipe the instrument for 30 seconds. Do not allow liquids to enter the interior of the instrument. To clean the display panel, use a cotton swab moistened with 70% isopropyl alcohol and gently wipe the panel. Cleaning WARNING: BEFORE CLEANING THE OXIMETER, ALWAYS TURN IT OFF AND MAKE SURE THE AC POWER CORD IS DISCONNECTED. Under normal operation, no internal adjustment or recalibration is required. This chapter covers how to test the operation, properly clean and how to obtain service for the Rad-8 oximeter. Introduction service / maintenance 9 9-1 9-2 9 The oximeter begins normal operation. 2. With the exception of the Power Button, press each button and verify that the oximeter acknowledges each key-press with an audible beep tone or by indicating a change on the display. Verify that the newly set parameter is shown on the Saturation Alarm Limit Display. Return the High Saturation Alarm parameter to its original setting. Repeat steps 1 to 3 with the Low Saturation Alarm parameter. Repeat steps 1 to 3 with the High Pulse Rate Alarm parameter. Repeat steps 1 to 3 with the Low Pulse Rate Alarm parameter. Reset the alarm limits again to the original settings. 2. 3. 4. 5. 6. 7. Exit the Menu system by pressing the Mode/Enter key or waiting for the normal time-out. 2. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual With the monitor turned on, select menu level 2 (see Section 4, Setup Menu Level 2 - button volume LED Brightness and Factory Defaults) and use the Up and Down Arrow keys to cycle through all 4 brightness levels. 1. LED Brightness: With the monitor turned on, select the depress alarm limits button and enter alarm menu. Change the High Saturation Alarm parameter to a value two points below the currently selected value, and accept the change. 1. Alarm Limit Test: 1. Key Press Button Test: Turn the monitor on by depressing the Power Button. For about 5 seconds all available LEDs are illuminated and a brief beep tone sounds. 1. Power-On Self-Test: Before performing the following tests verify unit is connected to AC power. Also disconnect any patient cables or pulse oximetry probes or serial cables from the instrument. To test the performance of the Rad-8 pulse oximeter following repairs or during routine maintenance, follow the procedure outlined in this section. If the Rad-8 fails any of the described tests, discontinue its use and correct the problem before returning the unit back to the user. Performance verification WARNING: THE BATTERY SHOULD BE INSTALLED AND/ OR REMOVED FROM THE RAD-8 BY QUALIFIED PERSONNEL ONLY. Battery Service service / maintenance Press the Alarm Silence button once and verify that the alarm is silenced and the Alarm Silence Indicator is flashing. Wait 120 seconds and verify that the alarm silence times out and the audible alarm is activated again and the Alarm Silence Indicator is off. 8. 9. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 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. 10. Press the up arrow button several times and verify that the loudness of the pulse beep tone increases. Verify that an audible alarm occurs and the SpO2 measurement and the Alarm indicator are both flashing. Verify that the pulse rate measurement is between 55 bpm and 65 bpm. 5. 7. Verify that the SpO2 measurement is between 79% and 84%. 4. Set the SpO2 low alarm limit to 90 (see Section 4, Setup Menu Level 1 - Alarm Limits and Alarm Volume). Verify that within 20 seconds a Signal IQ/pulsebar is displayed. 6. Connect the Masimo SET Tester to the Patient Cable Connecter. 2. Turn the Oximeter off and then on again. 3. 1. Testing the Rad-8 with Masimo SET Tester (Optional): service / maintenance 9 9-3 9-4 9 Masimo Japan Corporation World Times Bldg. 4F 10-7, Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 JAPAN Tel: 03 3237 3057 FAX: 03 3238 1110 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 Masimo Corporation 40 Parker Irvine, California 92618 Tel: 949-297-7000 FAX 949-297-7001 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual For Asia Pacific: For Europe: For USA: Return Rad-8 pulse oximeter to the following shipping address: ■ A certificate stating the oximeter has been decontaminated for bloodborne pathogens. ■ Person (name, telephone/Telex/fax number, and country) to contact for any questions about the repairs. ■ Ship-to and bill-to information. ■ Purchase order number to cover repair if the oximeter is not under warranty, or for tracking purposes if it is. ■ Warranty information – a copy of the invoice or other applicable documentation must be included. ■ A letter describing in detail any difficulties experienced with the pulse oximeter. Please include the RMA number in the letter. 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: RETURN PROCEDURE 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. To return the Rad-8 unit for service, please follow the Return Procedure. Grant of License: In consideration of payment of the license fee, which is part of the price paid for this product, MASIMO grants to Purchaser a nonexclusive, nontransferable license, without right to sublicense, to use the copy of the incorporated software/firmware and documentation in connection with Purchaser's use of the Masimo Products for their labeled purpose. MASIMO reserves all rights not expressly granted to Purchaser. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 1. THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE “PURCHASER,” AND Masimo Corporation (“MASIMO”). IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO MASIMO FOR A FULL REFUND. End-user license agreement THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO MASIMO’S PRODUCTS. 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. This warranty does not extend to any product that has been subject to misuse, neglect or accident; that has been damaged by causes external to the product; that has been used in violation of the operating instructions supplied with the product. The warranty does not extend to any product that has been connected to an unlicensed instrument system, modified accessories or any unit that has been disassembled or reassembled by anyone but an authorized Masimo agent. Exclusions To request a replacement or repair of an instrument under warranty, contact Masimo for a returned goods authorization. If Masimo determines that a product must be replaced or repaired under warranty, it will be replaced or repaired and the cost of shipment covered. All other shipping costs shall be the responsibility of the purchaser. Batteries are not warrantied. Masimo warrants to the initial purchaser that each new pulse oximeter will be free from defects in workmanship or materials for a period of one (1) year from the date of purchase. Masimo’s sole obligation under this warranty is to repair or replace any product that Masimo deems to be covered under warranty with a repaired or a replacement pulse oximeter. REPAIR POLICY Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the unit repaired. Please clean contaminated/dirty equipment before returning, following the cleaning procedure described in Section 9, Cleaning. Make sure it is fully dry before packing the equipment. Warranty service / maintenance Service and repair service / maintenance 9 9-5 9-6 9 Assignment: 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; any attempt without such consent, to assign any rights, duties or obligations arising hereunder shall be void. Copy Restrictions: The software/firmware 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 other written materials is expressly forbidden. You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17 U.S.C. §117. Use Restriction: As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not electronically transfer the software/firmware from the products to any other device. You may not disclose, publish, translate, release or distribute copies of the software/ firmware or accompanying written materials to others. You may not modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the software/firmware. You may not modify, adapt, translate, or create derivative works based on the written materials without the prior written consent of MASIMO. Transfer Restrictions: The software/firmware is licensed to the Purchaser, and may not be transferred to anyone, except other end-users, without the prior written consent of MASIMO. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis. Beneficiary: Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions. U.S. Government Rights: If you are acquiring software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the software is 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. 3. 4. 5. 6. 7. 8. Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in, any MASIMO software and/or firmware and the documentation, and all copies thereof, remain at all times vested in MASIMO Corporation, licensor to MASIMO, and they do not pass to Purchaser. 2. service / maintenance Rad-8 Operators Manual, Danish 13259 Rad-8 Operators Manual, Japanese Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual 30956 Rad-8 Operators Manual, Chinese Rad-8 Operators Manual, Dutch 13258 30955 Rad-8 Operators Manual, Swedish 13257 Rad-8 Operators Manual, Portuguese Rad-8 Operators Manual, Spanish 13256 13260 Rad-8 Operators Manual, Italian Rad-8 Operators Manual, German 13254 13255 Rad-8 Operators Manual, French Rad-8, Horizontal, Bulk Pack 9049 13253 Rad-8, Vertical 9020 Rad-8, Vertical, Bulk Pack Rad-8, Horizontal 9019 9050 DESCRIPTION PART NUMBER Rad-8 Units and Accessories accessories 13092/3371D-0207 10-1 10 www.masimo.com RadNet, PI, APOD and LNOPv are trademarks of Masimo Corporation. © 2007 Masimo Corporation. Masimo, Signal IQ, Discrete Saturation Transform, DST, Satshare, SET, LNCS and are federally registered trademarks of Masimo Corporation. , FastSat, Rad-8, Radlink, FastSat, SIQ, LNOP, Instruments and sensors containing Masimo SET technology are identified with the Masimo SET logo. Look for the Masimo SET designation on both the sensors and monitors to ensure accurate pulse oximetry when needed most.
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