Transcription of Rad-97 Operator's Manual - Masimo
1 Operator's Manual Rad-97 Pulse CO-Oximeter 1 Masimo These operating instructions provide the necessary information for proper operation of all models of the Rad-97 . There may be information provided in this Manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of Rad-97 are prerequisites for its proper use. Do not operate Rad-97 without completely reading and understanding these instructions. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling.
2 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings and precautions. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. Wireless Radio Contains: FCC ID: VKF-MWM1 | Model: Rad-97 | IC: 7362A- MWM1 | IC Model: MWM1 Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.
3 : 949-297-7000 Fax.: 949-297-7001 EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany 3149433 MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005,CAN/CSA No. 60601-1:2008, and applicable Particular (EN/ISO 80601-2-61:2011 and IEC 80601-2-30:2013) and related Collateral (IEC 60601-1-8:2006) Standards for which the product has been found to comply by Intertek. Patents: , Adaptive Probe Off Detection , APOD , Discrete Saturation Transform , DST , FastSat , FST , Masimo , Pulse CO-Oximeter , PVi , rainbow , rainbow Resposable , RRa , SET , Signal Extraction Technology , Signal IQ , SpCO , SpHb , and SpMet are federally registered trademarks of Masimo Corporation.
4 Rad-97 , NomoLine , rainbow Acoustic Monitoring , rainbow SET , RAM , Adaptive Threshold Alarm , In Vivo Adjustment , ORi , X-Cal , Kite , SpOC , and RRp are 2 Masimo trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. 2018 Masimo Corporation 3 Masimo Contents About This Manual ---------------------------------- ---------------------------------------- -----------------7 Product Description, Features and Indications for Use ---------------------------------------- ------- 9 Product Description ---------------------------------------- ---------------------------------------- ----- 9 Indications for Use ---------------------------------------- ---------------------------------------- ----- 11 Contraindications ---------------------------------------- ---------------------------------------- ------ 11 Safety Information.
5 Warnings and Cautions ---------------------------------------- ------------------ 13 Safety Warnings and Cautions ---------------------------------------- ------------------------------- 13 Performance Warnings and Cautions ---------------------------------------- ----------------------- 15 Cleaning and Service Warnings and Cautions ---------------------------------------- ------------ 21 Compliance Warnings and Cautions ---------------------------------------- ------------------------ 22 Chapter 1: Technology Overview ---------------------------------------- -------------------------------- 25 Signal Extraction Technology (SET ) ---------------------------------------- -------------------- 25 rainbow Pulse CO-Oximetry Technology ---------------------------------------- -------------------28 rainbow Acoustic Monitoring (RAM ) ---------------------------------------- ------------------- 33 Chapter 2.
6 Description ---------------------------------------- ---------------------------------------- ---- 37 General System Description ---------------------------------------- ---------------------------------- 37 Features ---------------------------------------- ---------------------------------------- ----------------- 38 Chapter 3: Setting Up-------------------------------------- ---------------------------------------- ------- 43 Unpacking and Inspection ---------------------------------------- ----------------------------------- 43 Preparation for Use ---------------------------------------- ---------------------------------------- ---- 43 Guidelines for Setting Up ---------------------------------------- ------------------------------------- 43 Powering the Rad-97 ON and OFF ---------------------------------------- --------------------------- 44 Initial Battery Charging
7 ---------------------------------------- --------------------------------------- 44 Nurse Call Connection ---------------------------------------- ---------------------------------------- 45 Attach NIBP Cuff ---------------------------------------- ---------------------------------------- ------- 45 NomoLine capnography Sampling Line Connection ---------------------------------------- ---- 45 Masimo Kite ---------------------------------------- ---------------------------------------- ------------- 46 Third-Party Devices ---------------------------------------- ---------------------------------------- ---- 46 Chapter 4.
8 Operation ---------------------------------------- ---------------------------------------- ------ 47 Using the Touchscreen and Home Button ---------------------------------------- ----------------- 47 About the Main Screen ---------------------------------------- ---------------------------------------- 51 Rad-97 Contents 4 Masimo About the System Status Light ---------------------------------------- ------------------------------ 59 Accessing Main Menu Options ---------------------------------------- ------------------------------ 61 Parameter Settings ---------------------------------------- ---------------------------------------- ---- 64 Noninvasive Blood Pressure (NIBP)
9 Settings ---------------------------------------- ------------- 84 NomoLine capnography Settings ---------------------------------------- --------------------------- 89 Sounds ---------------------------------------- ---------------------------------------- ------------------- 95 Device Settings ---------------------------------------- ---------------------------------------- --------- 96 About ---------------------------------------- ---------------------------------------- ------------------- 106 Trends ---------------------------------------- ---------------------------------------- -------------------107 Rad-97 Screenshot Capture ---------------------------------------- -------------------------------- 109 Patient Admit/Discharge ---------------------------------------- ------------------------------------ 111 Chapter 5.
10 Profiles ---------------------------------------- ---------------------------------------- -------- 113 Profiles Overview ---------------------------------------- ---------------------------------------- ------ 113 Changing Profiles ---------------------------------------- ---------------------------------------- ----- 113 Profiles Settings ---------------------------------------- ---------------------------------------- ------- 115 Replacing Factory Default Settings for Adult, Pediatric and Neonatal Profiles ------------ 115 Chapter 6: Noninvasive Blood Pressure (NIBP) ---------------------------------------- ------------- 117 Operation - NIBP ---------------------------------------- ---------------------------------------- ------ 117 Patient Category ---------------------------------------- ---------------------------------------- ------ 117 Patient Conditions ---------------------------------------- ---------------------------------------- ---- 117 Cuff Selection and Placement ---------------------------------------- ------------------------------ 118 Blood Pressure Measurement ---------------------------------------- ------------------------------- 119 Chapter 7.
