Masimo Root Bedienungsanleitung

Addendum

Root®

with Pathway

www.masimo.com 1 Masimo

Not for Sale in the USA - For Export Only

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 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: Use of this device must follow the order of a physician.

For professional use. See instructions for use for full prescribing information, including

indications, contraindications, warnings, and precautions.

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

Authorized Brazil Company Representative:

MEDSTAR IMPORT AND EXPORT EIRELI

R VALENCIO SOARES RODRIGUES, 89- ROOM 1

CEP: 06.730-000

NEIGHBORHOOD: CENTER

MUNICIPALITY: VARGEM GRANDE PAULISTA

UF: SP

3149433

MEDICAL ELECTRICAL EQUIPMENT

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH

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

®, Masimo®, MOC-9®, Radical-7®, Radius-7®, rainbow®, Root®, SedLine®, SET®, and

Signal Extraction Technology® are federally registered trademarks of Masimo Corporation.

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

www.masimo.com 2 Masimo

www.masimo.com 3 Masimo

Contents

Addendum, Root Operator's Manual: Root with Pathway-------------------------------------------- 5

Product Description, Features and Indications for Use------------------------------------------------7

Key Feature Update--------------------------------------------------------------------------------------7

Safety Information, Warnings, and Cautions----------------------------------------------------------- 9

Performance Warnings and Cautions---------------------------------------------------------------- 9

Operation---------------------------------------------------------------------------------------------------- 11

Accessing Main Menu Options for Pathway ------------------------------------------------------- 11

Pathway Settings--------------------------------------------------------------------------------------- 12

Device Settings-----------------------------------------------------------------------------------------15

Pathway------------------------------------------------------------------------------------------------------ 19

About the Pathway Main Screen -------------------------------------------------------------------- 19

Pathway Procedure------------------------------------------------------------------------------------- 21

Messages ----------------------------------------------------------------------------------------------------29

Troubleshooting-------------------------------------------------------------------------------------------- 31

Root Troubleshooting --------------------------------------------------------------------------------- 31

www.masimo.com 5 Masimo

Addendum, Root Operator's Manual:

Root with Pathway

This addendum provides updates to the following:

Operator's Manual, Root®

•37365/LAB-8425 and equivalent translations

•37503/LAB-8542 and equivalent translations

Operator's Manual, Root® with noninvasive blood pressure and temperature

•37705/LAB-8747 and equivalent translations

•38280/LAB-9274 and equivalent translations

This addendum covers the Pathway feature of the Root device. For all other information, refer

to the Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood

pressure and temperature.

www.masimo.com 7 Masimo

Product Description, Features and

Indications for Use

The following information is an addendum to be used with the content in Product

Description, Features and Indications for Use of the Operator's Manual, Root® or Operator's

Manual, Root® with noninvasive blood pressure and temperature.

Key Feature Update

The following added feature is available for Root:

•Pathway is an optional continuous monitoring mode which allows clinicians to set

a visual indicator of the preferred oxygen saturation range during the first 10

minutes after birth.

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