Addendum
36 Pages
Preview
Page 1
Addendum
Root®
with Pathway
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
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© 2019 Masimo Corporation
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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
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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.
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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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Safety Information, Warnings, and Cautions The following information is an addendum to be used with the content in Safety Information, Warnings and Cautions of the Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature. CAUTION: Before using Pathway on Root, completely read and understand the Operator's Manual, Radical-7, Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature. This addendum to the Operator's Manual provides specific instructions about using Pathway.
Performance Warnings and Cautions Pathway WARNING: Monitoring in the Pathway mode is not intended to direct or prescribe a clinical treatment or therapy decision. The clinical treatment and therapy decision should be evaluated in conjunction with the patient’s clinical status and confirmed with additional diagnostic tests consistent with each hospital’s policy. Any concern about a patient’s clinical condition should prompt an urgent clinical review, irrespective of monitoring results. WARNING: Visual indicator of the glide path should be adjusted according to the hospital’s policy and should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. Note: The time scrub button should be adjusted to reflect the actual elapsed time. The default time indicated is based upon the elapsed time from the start of use of the mode.
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Operation The following information is an addendum to be used with the content in Chapter 3: Operation of the Operator's Manual, Radical-7, Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature.
Accessing Main Menu Options for Pathway To access the Pathway Main Menu options, press the Main Menu icon at the bottom right corner of the touchscreen:
The Main Menu options include Root specific settings as well as Root settings. Options in the Main Menu include the following: Pathway Settings See Pathway Settings on page 12. Sounds*
Device Settings See Device Settings. About*
* For Root settings not related to Pathway, refer to Chapter 3: Operation of the Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature.
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Operation
Pathway Settings
Pathway settings include the following: Parameter Settings*, ** See Parameter Settings on page 12. Additional Settings See Additional Settings on page 13. SpO2 Pathway Alarms** See SpO2 Pathway Alarms on page 13. SpO2 Target Range See SpO2 Target Range on page 14. PR Threshold See PR Threshold on page 15. * Only displays when Radical-7 is docked to Root. ** The SpO2 Pathway Alarms control the alarm limits during the first 10 minutes of Pathway operation. After 10 minutes of Pathway operation, the SpO2 Parameter Settings control the alarm limits.
Parameter Settings
Parameter Settings display only when Radical-7 is docked to Root. Note: The Neonatal profile is selected by default for all Radical-7 parameter settings during Pathway operation. For information about configuring the Parameter Settings related to Pathway, refer to Chapter 3: Operation of the Operator's Manual, Radical-7 Pulse CO-Oximeter.
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Additional Settings
From the Additional Settings screen, change any of the following options: Option
Description
Factory Default Settings
SmartTone Allows the audible pulse to continue to Off beep when the pleth graph shows signs of motion.
User Configurable Settings On or Off
SpO2 Pathway Alarms
The SpO2 Pathway Alarms allow the user to optionally adjust alarm limits during the first 10 minutes when used in Pathway mode. After 10 minutes, the alarm limits revert to the ones set as part of the SpO2 Parameter Settings. From the SpO2 Pathway Alarms settings screen, change any of the following options: Options
Description
Factory Default User Configurable Settings Settings
High Limit
High Limit is the upper threshold that triggers an alarm.
99
2 to 99 in steps of 1, or Off
Low Limit Low Limit is the lower threshold that triggers an alarm.
88
1 to 98 in steps of 1
Silence Duration
Sets the amount of time that the alarm is 2 minutes silenced.
30 seconds, 1 or 2 minutes
Rapid Desat
Sets the Rapid Desat limit threshold to -10 the selected amount below the Low Alarm Limit. When SpO2 value falls below rapid desat limit the audio and visual alarm are immediately triggered without respect to the alarm delay.
Off, -5, or -10
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Options
Description
Factory Default User Configurable Settings Settings
Alarm Delay
When an alarm condition is met, this feature delays the audible part of an alarm.
10
0, 5, 10, or 15
SpO2 Target Range
Use the SpO2 Target Range settings screen to configure the Glide Path visualization. See Pathway Screen on page 20. Option Description
Factory Default Settings* User Configurable Settings**
SpO2 Max
60
60 to 98 in steps of 1
SpO2 Min
65
61 to 99 in steps of 5
SpO2 Max
65
60 to 98 in steps of 1
SpO2 Min
70
61 to 99 in steps of 1
SpO2 Max
70
60 to 98 in steps of 1
SpO2-axis Min 75
61 to 99 in steps of 1
SpO2 Max
75
60 to 98 in steps of 1
SpO2 Min
80
61 to 99 in steps of 1
SpO2 Max
80
60 to 98 in steps of 1
SpO2 Min
85
61 to 99 in steps of 1
SpO2 Max
85
60 to 98 in steps of 1
SpO2-axis Min 95
61 to 99 in steps of 1
1 Min
2 Min
3 Min
4 Min
5 Min
10 Min * Default settings are established based upon the recommendation made by Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin, JG. Part 13: neonatal resuscitation: 2015 American Heart Association Guidelines Update for www.masimo.com
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Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015;132(suppl 2):S543–S560. ** Visual indicators only. Audible alarms only occur when the Radical-7 high and low alarm limits are reached. Refer to the Operator's Manual, Radical-7® Pulse CO-Oximeter®.
PR Threshold
From the PR Threshold settings screen, change any of the following options. Default settings are established based upon the recommendation made by the International Liaison Committee on Resuscitation (ILCOR). Options
Description
Factory Default Settings*
User Configurable Settings**
Low Limit
Adjusts the low limit threshold visual indicator.
100
35 to 235 in steps of 5
Critical Limit
Adjusts the critical limit threshold 60 visual indicator.
30 to 230 in steps of 5
* Default settings are established based upon the recommendation made by Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin, JG. Part 13: neonatal resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015;132(suppl 2):S543–S560. ** Visual indicator only. Audible alarms only occur when the Radical-7 high and low alarm limits are reached. Refer to the Operator's Manual, Radical-7® Pulse CO-Oximeter®.
Device Settings
On Root equipped with Pathway, some Device Settings options change and are reflected below: Access Control See Access Control on page 16.
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Access Control
Access Control contains configurable options and settings that require a password. To enter Access Control 1.
Press the
2.
When the numeric screen displays, enter the following numbers: 6 2 7 4 Asterisks (****) will be displayed. To undo an entry, press Backspace. Press Enter to access the password protected screen. Note: The password will have to be entered every time this screen is accessed.
3.
key.
Option
Description
Factory Default Configurable Settings Setting
All Mute Enabled
Enables or disables parameter Alarm Silence menu option. See Sounds.
Off
On or Off
Lock Alarm Volume
Sets the lowest alarm volume level.
Off
3, 4, or Off
USB Port 1* baud rate
Enables option to change baud rate of device.
921600
9600, 19200, 38400, 57600, 115200, 230400, or 921600
option to USB Port 2* Enables change baud rate of baud rate device.
921600
9600, 19200, 38400, 57600, 115200, 230400, or 921600
Data Collection Enabled
Off
On or Off
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Enables or disables physical data collection mode.
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Option
Description
Factory Default Configurable Settings Setting
Factory Defaults
Options are restored to factory value.
N/A
Press Restore.
*Changes to USB Ports baud rate will take effect after Root is power cycled (turned off then on again). Note: Restore Factory Defaults can only be performed during non-monitoring and when no cable connections are present.
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Pathway Before using Pathway on Root, completely read and understand the Operator's Manual, Radical-7, Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature. Select the appropriate Masimo sensor and completely read and understand the Directions for Use of the Masimo sensor. See Safety Information, Warnings, and Cautions on page 9.
About the Pathway Main Screen The Main Screen consists of different areas.
Ref. Feature
Information
1
See Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature.
Status Bar
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Ref. Feature
Pathway
Information
2
Pathway Operation Start Button
See Pathway Procedure on page 21.
3
Main Menu
See Accessing Main Menu Options for Pathway on page 11.
Pathway Screen The Pathway screen details are described below.
Item Name
Description
1
SpO2 Measurement Window
Displays the Glide Path and SpO2 measurements.
2
PR Measurement Window
Displays the PR measurements.
3
Time Rule
Current location of the SpO2 and PR measurements.
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Pathway
Item Name
Description
4
Displays the elapsed time and allows adjustment to the time.
Time Scrub Button
See Time Adjustment on page 26. 5
Glide Path
The set Min and Max SpO2 Target Range. See SpO2 Target Range on page 14.
6
Trend
Displays the trends for SpO2 and PR. See Trend on page 23.
Parameter Window Below the Pathway Screen is the Parameter Window. The Parameter Window displays parameters available on Radical-7.
Pathway Procedure To use Pathway, perform the following: 1. 2. 3.
Select the appropriate Masimo sensor and completely read and understand the Directions for Use of the Masimo sensor. Attach a cable and sensor to Radical-7 and the patient. From the Pathway Main Screen, press the Start button to begin.
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Note: If Radical-7 is not attached to Root, Please Connect a Device displays on the screen below the Start button. Once the sensor signal is acquired, measurement begins automatically. 4.
During the first minute of measurement, the glide path is not displayed. The glide path only displays from one (1:00) minute to ten (10:00) minutes. The Time Scrub Button displays the elapsed time.
5.
After ten (10:00) minutes of measurement the following occurs: •
The glide path moves off the screen as the time advances past ten minutes.
•
Panning is allowed and will have a one minute no touch timeout. After the timeout, the view returns to the current location in the measurement time.
•
Panning forward beyond the current time will snap back to the current location in the measurement time.
•
Panning backward beyond zero will snap to zero.
•
The current Pathway session continues until manually ended.
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6.
Pathway
After 96 hours the Time Scrub Button displays >96:00:00.
To stop the Pathway procedure, select the Stop button at the bottom of the screen. Confirm by selecting the Stop button again in the confirmation window. The screen returns to the Pathway Main Screen. To continue with the Pathway procedure, select Cancel in the confirmation window.
Trend The SpO2 and PR trends display on the Pathway screen. Note: Panning left/right on the screen is disabled during the first 11 minutes of monitoring. The SpO2 trend changes colors depending on location in relation to the glide path (target range). See SpO2 Target Range on page 14. SpO2 trend colors include: •
Black - before and after the glide path.
•
Green - within the glide path.
•
Red - above or below the glide path.
The PR trend changes colors depending on relation to the PR Threshold Settings. See PR Threshold on page 15. PR trend colors include: www.masimo.com
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•
Black - above the set PR Threshold Low Limit.
•
Yellow - below the set PR Threshold Low Limit but above the set Critical Limit.
•
Red - below the set PR Threshold Critical Limit.
Visual Indicators In Pathway mode, visual indicators are provided under the following circumstances, based upon the hospital's established Glide Path visualization settings. See SpO2 Target Range on page 14. •
SpO2 is Low. See description of SpO2 Low on page 24.
•
SpO2 is High. See description of SpO2 High on page 25.
•
PR is Low. See description of PR Low (Below 100 bpm) on page 26.
•
PR is Critical. See description of PR Critical (Below 60 bpm) on page 26.
Note: Visual indicators of deviations of the SpO2 and PR from the Glide Path are not alarms and therefore will not generate audible alarms.
SpO2 Low When SpO2 is below the glide path: •
Red SpO2 indicator and red glow from the bottom edge of the trend.
•
No message displays in the header.
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