Masimo Root Bedienungsanleitung

Operator's Manual

Root®

with noninvasive blood pressure and

temperature

www.masimo.com 1 Masimo

For Sale in the USA

These operating instructions provide the necessary information for proper operation of all models of the

Root. 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 Root are prerequisites

for its proper use. Do not operate Root without completely reading and understanding these instructions.

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.

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.

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.

Wireless Radio

FCC ID:VKF-RDS7A IC:7362A-RDS7A IC Model: RDS7A

Masimo Corporation

52 Discovery

Irvine, CA 92618, USA

Tel.: 949-297-7000

Fax.: 949-297-7001

www.masimo.com

EU authorized representative for Masimo Corporation:

MDSS GmbH

Schiffgraben 41

D-30175 Hannover, Germany

3149433

MEDICAL ELECTRICAL EQUIPMENT

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN

ACCORDANCE WITH

Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1, and applicable

Particular (IEC 60601-2-49, IEC 80601-2-30, ISO 80601-2-56) and related Collateral (IEC

60601-1-8:2006) Standards for which the product has been found to comply by Intertek.

Patents: www.masimo.com/patents

, Iris, Masimo, MOC-9, PVi, Radical-7, Radius-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction

Technology, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation.

ISA, MyView, and SpOC are trademarks of Masimo Corporation.

The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

All other trademarks and registered trademarks are property of their respective owners.

www.masimo.com 3 Masimo

Contents

About This Manual-------------------------------------------------------------------------------------------7

Product Description and Features, Intended Use and Indications for Use ----------------------- 9

Product Description and Features-------------------------------------------------------------------- 9

Intended Use -------------------------------------------------------------------------------------------- 9

Indications for Use-------------------------------------------------------------------------------------- 9

Contraindication --------------------------------------------------------------------------------------- 11

Safety Information, Warnings, and Cautions----------------------------------------------------------13

Safety Warnings and Cautions----------------------------------------------------------------------- 13

Performance Warnings and Cautions---------------------------------------------------------------16

Cleaning and Service Warnings and Cautions ----------------------------------------------------18

Compliance Warnings and Cautions----------------------------------------------------------------19

Chapter 1: Description ------------------------------------------------------------------------------------ 21

Features-------------------------------------------------------------------------------------------------- 21

Chapter 2: Setting Up-------------------------------------------------------------------------------------25

Unpacking and Inspection ---------------------------------------------------------------------------25

Guidelines for Setting Up-----------------------------------------------------------------------------25

Power On ------------------------------------------------------------------------------------------------26

Initial Battery Charging ------------------------------------------------------------------------------- 27

Radical-7 Connection----------------------------------------------------------------------------------28

Radius-7 Connection-----------------------------------------------------------------------------------28

MOC-9 Connection-------------------------------------------------------------------------------------29

Nurse Call Connection ------------------------------------------------------------------------------- 30

Attach the Probe Well-------------------------------------------------------------------------------- 30

Attach the Temperature Probe ----------------------------------------------------------------------31

Attach NIBP Cuff --------------------------------------------------------------------------------------- 31

Masimo Kite--------------------------------------------------------------------------------------------- 31

Bluetooth Devices--------------------------------------------------------------------------------------31

Chapter 3: Operation------------------------------------------------------------------------------------- 33

About the Main Screen------------------------------------------------------------------------------- 33

About the Status Bar ----------------------------------------------------------------------------------34

About the Action Bar --------------------------------------------------------------------------------- 36

Root NIBPT Contents

www.masimo.com 4 Masimo

Using the Touchscreen Interface-------------------------------------------------------------------- 37

Menu Navigation --------------------------------------------------------------------------------------40

Understanding Windows ----------------------------------------------------------------------------- 41

Accessing Main Menu Options ---------------------------------------------------------------------- 49

Alarm Interface----------------------------------------------------------------------------------------- 77

Trend Download---------------------------------------------------------------------------------------- 81

Session Management ---------------------------------------------------------------------------------82

Screen Capture -----------------------------------------------------------------------------------------83

Lights ----------------------------------------------------------------------------------------------------86

Chapter 4: Temperature Measurement ----------------------------------------------------------------89

Operation - Temperature -----------------------------------------------------------------------------89

Temperature Probes----------------------------------------------------------------------------------- 91

Chapter 5: NIBP Measurement--------------------------------------------------------------------------93

Patient Measurement Mode -------------------------------------------------------------------------93

Cuff Selection and Placement -----------------------------------------------------------------------93

Patient Conditions------------------------------------------------------------------------------------- 94

Operation - NIBP---------------------------------------------------------------------------------------95

Chapter 6: Admit and Discharge to Patient SafetyNet ------------------------------------------- 103

Not Admitted ----------------------------------------------------------------------------------------- 103

Admitting a Patient --------------------------------------------------------------------------------- 104

Discharging a Patient ------------------------------------------------------------------------------- 105

Not Monitoring Message --------------------------------------------------------------------------- 106

Monitoring Resumed Message----------------------------------------------------------------------107

Chapter 7: Electronic Medical Record (EMR) Push------------------------------------------------- 109

Determining EMR Push is Active------------------------------------------------------------------ 109

Manually Entering Patient Data------------------------------------------------------------------- 109

Sending Patient Data to the EMR----------------------------------------------------------------- 110

Chapter 8: Radical-7 ------------------------------------------------------------------------------------- 111

Chapter 9: Radius-7 --------------------------------------------------------------------------------------113

Chapter 10: MOC-9---------------------------------------------------------------------------------------115

Using MOC-9 Ports -----------------------------------------------------------------------------------115

Chapter 11: Iris-------------------------------------------------------------------------------------------- 117

Using Iris Connectivity Ports -----------------------------------------------------------------------118

Root NIBPT Contents

www.masimo.com 5 Masimo

Iris Icon ------------------------------------------------------------------------------------------------ 119

Iris Screen --------------------------------------------------------------------------------------------- 120

Chapter 12: Bluetooth Devices ------------------------------------------------------------------------ 123

Connect Device to Root ----------------------------------------------------------------------------- 123

Chapter 13: Messages----------------------------------------------------------------------------------- 125

Chapter 14: Troubleshooting -------------------------------------------------------------------------- 129

Troubleshooting Radical-7, Radius-7, and MOC-9 Modules----------------------------------- 129

Troubleshooting Root ------------------------------------------------------------------------------- 129

Chapter 15: Specifications ----------------------------------------------------------------------------- 133

Measurement Accuracy ----------------------------------------------------------------------------- 133

Alarms-------------------------------------------------------------------------------------------------- 134

Nurse Call Specifications --------------------------------------------------------------------------- 134

Connectors -------------------------------------------------------------------------------------------- 134

Display Ranges --------------------------------------------------------------------------------------- 135

NIBP Pressurization Ranges ----------------------------------------------------------------------- 136

Electrical----------------------------------------------------------------------------------------------- 136

Environmental---------------------------------------------------------------------------------------- 136

Touchscreen Display--------------------------------------------------------------------------------- 137

Wireless Specifications------------------------------------------------------------------------------ 137

Compliance-------------------------------------------------------------------------------------------- 139

Guidance and Manufacturer's Declaration-Electromagnetic Emissions---------------------141

Guidance and Manufacturer's Declaration-Electromagnetic Immunity -------------------- 142

Recommended Separation Distances ------------------------------------------------------------ 144

Symbols------------------------------------------------------------------------------------------------ 145

Chapter 16: Service and Maintenance --------------------------------------------------------------- 149

Cleaning ----------------------------------------------------------------------------------------------- 149

Replacing the Fuses --------------------------------------------------------------------------------- 149

Power-On Self Test----------------------------------------------------------------------------------- 150

NIBP Module Calibration Test --------------------------------------------------------------------- 150

Zero Point Calibration------------------------------------------------------------------------------- 152

Span Point Calibration------------------------------------------------------------------------------ 153

NIBP Air Leak Test ----------------------------------------------------------------------------------- 154

Overpressure Test------------------------------------------------------------------------------------ 156

Root NIBPT Contents

www.masimo.com 6 Masimo

Nurse Call Setting Connections ------------------------------------------------------------------- 159

Battery Test------------------------------------------------------------------------------------------- 160

Repair Policy------------------------------------------------------------------------------------------ 160

Return Procedure ------------------------------------------------------------------------------------ 160

Masimo Technical Services ------------------------------------------------------------------------ 160

Contacting Masimo-----------------------------------------------------------------------------------161

Appendix: Concepts of Alarm Response Delay ----------------------------------------------------- 163

Concepts of Alarm Response Delay --------------------------------------------------------------- 163

Index ------------------------------------------------------------------------------------------------------- 165

www.masimo.com 7 Masimo

About This Manual

This manual explains how to set up and use Root® with noninvasive blood pressure and

temperature. Important safety information relating to general use of Root appears in this

manual. Read and follow any warnings, cautions, and notes presented throughout this

manual. The following are explanations of warnings, cautions, and notes.

A warning is given when actions may result in a serious outcome (for example, injury, serious

adverse effect, death) to the patient or user.

WARNING: This is an example of a warning statement.

A caution is given when any special care is to be exercised by the patient or user to avoid

injury to the patient, damage to this device, or damage to other property.

CAUTION: This is an example of a caution statement.

A note is given when additional general information is applicable.

Note: This is an example of a note.

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