MASiMO Pulse CO-Oximeter Rad-97 User Manual

: June 7, 2024
: MASiMO

Table of Contents

Addendum, Rad-97 Operator’s Manual:
Safety Information, Warnings, and Cautions
Operation
EWS Calculation Using Vital Signs Check (VSC)
Troubleshooting
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Addendum
Rad-97™ Pulse CO-Oximeter®
with EWS

MASiMO Pulse CO-Oximeter Rad-97 -

These operating instructions provide the necessary information for the proper operation of all models of the Rad-97. There may be information provided in this manual that is not relevant to 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.
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.
MASiMO Pulse CO-Oximeter Rad-97 -CE 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

MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No. 60601-1:2008, and
applicable Particular (EN/ISO 80601-2-61:2011) 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.htm
®, Masimo® and Pulse CO-Oximeter®, PVi®, rainbow®, RRa®, SpCO®, SpHb®, and SpMet® are federally registered trademarks of Masimo Corporation. Rad-97™, SpOC™, and TIR-1™ are 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.
© 2019 Masimo Corporation

Addendum, Rad-97 Operator’s Manual:

Early Warning Score (EWS)

This addendum provides updates to the following:
Operator’s Manual, Rad-97™ Pulse CO-Oximeter®

38053/LAB-9103 and equivalent translations
38281/LAB-9275 and equivalent translations
This addendum covers the Early Warning Score (EWS) operation of the Rad-97 device. All For other information, refer to the above-listed manuals.

Safety Information, Warnings, and Cautions

Performance Warnings and Cautions

WARNING: The Early Warning Score (EWS) feature is intended to help clinicians calculate Early Warning Scores based upon established methods.
WARNING: The Early Warning Score (EWS) feature is not intended as a definitive clinical assessment of the patient’s condition. The result 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 EWS.
WARNING: Confirm the Early Warning Score (EWS) being used is suitable for the patient type. Certain EWS systems may exclude certain patient types (e.g. Children <16 years, pregnant women) because the physiological response to acute illness can be modified.
WARNING: Confirm the Early Warning Score (EWS) being used is suitable for the patient’s condition. Certain EWS systems may be unreliable on patients with certain conditions (e.g. spinal cord injury, tetraplegia, high-level paraplegia) owing to functional disturbances of the autonomic nervous system.
Note: The Early Warning Score (EWS) is a static calculation based upon the captured and manually inputted parameter data at the time of the calculation request.

Operation

Early Warning Score (EWS)

The EWS is an optional feature of Rad-97 and must be configured by qualified Masimo personnel only.
Rad-97 has the ability to automate Early Warning Score (EWS) calculations based upon published standards such as National Early Warning Score (NEWS), Pediatric Early Warning Score (PEWS), or can be customized to match a facility’s protocol.
The following information is an example of when Rad-97 is configured with National Early Warning Score (NEWS) calculations.
EWS on Rad-97 is aligned with the NEWS system established by the Royal College of Physicians using seven (7) physiological contributors as the basis of the scoring system.
Based on NEWS, each physiological contributor is scored from 0 to 3 according to the mapping from its range to a score (for example, pulse rate from 51 to 90 equates to a 0
score). All of the scores are aggregated to provide the NEWS.
The EWS feature works by automating established EWS calculations based upon all of the following contributors:

Oxygen Saturation (SpO2)
Pulse Rate (PR)
Respiration Rate (RR)
Body Temperature (TEMP)
Systolic Blood Pressure (SYS)
Level of Consciousness (LOC)
Supplemental O2 (Sup. O2)

Rad-97 can also be configured** to include the following additional contributors:

Respiratory Distress (RD)
Capillary Refill Time (CRT)
The EWS calculation can be performed one of two (2) ways:
EWS Calculation Using Vital Signs Check : When in Vital Signs Check (VSC) Mode, through VSC operation. See EWS Calculation Using Vital Signs Check (VSC) on page 12.
EWS Calculation Using EMR Push: When connected to Patient SafetyNet and an EMR system, through EMR Push operation. See EWS Calculation Using EMR Push on page 11.
For information on how EWS is calculated, see How the EWS is Calculated on page 10.
*Royal College of Physicians. National Early Warning Score (NEWS): Standardising the assessment of acute illness severity in the NHS. Report of a working party. London: RCP, 2012.
**Configured by authorized personnel only.

Rad-97 with EWS
Operation

***The use of the trademark PATIENT SAFETYNET is under license from University Health System Consortium.

How the EWS is Calculated
The following information is an example of when Rad-97 is configured with National Early Warning Score (NEWS) calculations. Individual EWS contributors are scored in accordance with the guidance provided by NEWS.
Note: These scores are a reflection of NEWS standards; they may not be reflective of NEWS if Rad-97 is customized.

Score/Physiological Parameters	3*	2	1	0	1	2	3*
Oxygen Saturation (SEO )	≤91	92-93	94.95≥	≥96	—	—	—
Pulse Rate (PR)	≤40	—	41-50	51.90	91-110	111-130	≥131
Respiration Rate (RR)	≤8	—	9.11	12.20	—	21-24_	≥25
Body Temperature (TEMP) °C	≤35.0	—	35.1-36.0	36.1-38.0	38.1-39.0
a39.1	—
Body Temperature (TEMP) °F	≤95.0	—	95.1 –
96.8	96.9 –
100.4	100.5-
102.2	>_1 02.3	—
Systolic Blood Pressure (SYS )	≤90	91-100	101-110	111-219	—	—	≥220
Level of Consciousness (LOC)	—	—	—	A	—	—	V, P,

orU
Supplemental 02 (Sup. 0.)| —| Yes| —| No| —| —| —

A score of 3 is representative of an extreme variation in a single physiological parameter.

EWS Calculation Using EMR Push
EWS Calculation when in Continuous Mode is performed through EMR Push when Rad-97 is connected to Patient SafetyNet and an EMR system and a patient is admitted.
For more information about admitting a patient and using EMR push, see Patient Admit/Discharge and EMR Push in the Operator’s Manual, Rad-97™ Pulse CO-Oximeter®.

To perform an EWS Calculation Using EMR Push, select the EMR Push icon .
.Manually input any EWS contributors not automatically captured.
Note: Automatically captured data cannot be manually adjusted. Manual- entry contributors will be provided with a drop-down or slider to allow data entry.
Select the Review button. The EWS individual contributor scores (1) and EWS aggregate score (2) are displayed at the top of the EMR Push: Review screen.
Select the Submit button to send the data to the EMR system. The individual contributor scores and EWS aggregate scores and are sent to the EMR system. Select the Back button to return to the EMR Push screen.

EWS Calculation Using Vital Signs Check (VSC)

When Rad-97 is in Vital Signs Check Mode, the EWS Calculation is performed when a Vital Signs Check session is saved or sent. When the Rad-97 is connected to Patient SafetyNet and an EMR system, the VSC session and EWS calculations are sent to the EMR.
For more information about Vital Signs Check (VSC) mode and operation, see the Addendum, Rad-97™ Pulse CO-Oximeter® with Vital Signs Check.

To perform an EWS Calculation, perform a Vital Signs Check. When complete, select the Next button. The EWS individual contributor scores (1) and EWS aggregate score (2) are displayed at the top of the VSC session screen. Scroll to the bottom of the VSC screen and manually input any EWS contributors not automatically captured.
Note: Automatically captured data cannot be manually adjusted. Manual- entry contributors will be provided with a drop-down or slider to allow data entry.After selecting dates for additional contributors, they are reflected in the EWS information.
Select the Save or Send button.
• When NOT connected to Patient SafetyNet the Save button is displayed. The individual contributor scores and EWS aggregate score are saved in a session on Rad-97 along with the VSC results. See Sessions in the Addendum, Rad-97™ Pulse CO-Oximeter® with Vital Signs Check.
• When connected to Patient SafetyNet the Send button is displayed. The individual contributor scores and EWS aggregate scores are sent to the EMR system along with the VSC results. A session is also saved on Rad-97.

EWS Clinical Risk Level Indicators

WARNING: The Early Warning Score (EWS) feature is intended to help clinicians calculate Early Warning Scores based upon established methods.
WARNING: The Early Warning Score (EWS) feature is not intended as a definitive assessment of the patient’s condition. The result should be evaluated in conjunction with the patient’s clinical status and confirmed with additional diagnostic tests consistent with each hospital’s policy.
Clinical risk levels default to those established by the Royal College of Physicians for
NEWS.
The aggregate EWS score on Rad-97 provides the following color indicators for different clinical risk levels:

EWS Score	Clinical Risk	Aggregated Score Color
0 or an aggregate EWS of 1 to 4	Low	Green

Individual parameter score of 3
Or
Aggregate EWS score of 5 to 6| Medium| Yellow
Aggregate EWS of 7 or higher| High| Red

E Indicator
The E Indicator appears when a contributor exceeds a user-defined threshold. Thresholds are customized using the Masimo Instrument Configuration Tool (MICT) by authorized personnel. When the contributor threshold is exceeded, the overall EWS score is replaced with an “E” in a red box (see screenshot below). Each contributor can be configured to have an E Indicator.