Radical Operators Manual Aug 2007

Operators Manual

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signal extraction pulse oximeter OPERATOR’S

MANUAL

Signal Extraction Pulse Oximeter OPERATOR’S

MANUAL

The Radical Operating Instructions provide the necessary information for proper operation of all models of the Radical pulse oximetry system.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 the Radical Pulse Oximeter are a prerequisite for its proper use. Do not operate the Radical Pulse Oximeter without completely reading and understanding the instructions in this manual. NOTICE Purchase or possession of this device does not carry any express or implied license to use this device with replacement parts which would, alone or in combination with this device, fall within the scope of one of the patents relating to this device. CAUTION: FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU Authorized Representative for Masimo Corporation:

EC REP MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33 MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 No. 601.1 Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare® feature are also covered by U.S. Patent 6,770,028. Other patents pending. © 2007 Masimo Corporation. Masimo, Radical, Discrete Saturation Transform, DST, Satshare,SET, LNOP, LNCS and LNOPv are federally registered trademarks of Masimo Corporation. RadNet, RadicalScreen, Signal IQ, FastSat, FastStart and APOD are trademarks of Masimo Corporation.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Radical Signal Extraction Pulse Oximeter is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation.

■

Do not place containers containing liquids on or near the pulse oximeter. Liquids spilled on the pulse oximeter may cause it to perform inaccurately or fail.

■

Explosion hazard. Do not use the Pulse Oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.

■

Failure of Operation - If the pulse oximeter fails any part of the setup procedures or leakage tests, remove the pulse oximeter from operation until qualified service personnel have corrected the situation. Patient Safety - If a sensor is damaged in any way, discontinue use immediately.

■

Disposal of product - Comply with local laws in the disposal of the unit and/or its accessories.

■

High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the Pulse Oximeter to obtain vital sign readings.

■

The Pulse Oximeter Module can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.

■

The Pulse Oximeter is NOT intended for use as an apnea monitor.

■

A Pulse Oximeter should be considered an early warning device. As a trend towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition.

■

The Pulse Oximeter is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use.

■

Electric shock hazard. Do not open the pulse oximeter cover except to replace the battery of the Handheld unit. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.

This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

■

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

❚ Reorient or relocate the receiving device.

■

Do not place the pulse oximeter or accessories in any position that might cause it to fall on the patient. Do not lift the pulse oximeter by the power cord or any other cable.

■

❚ Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

Interfering Substances: SpO2 is a functional calculation of arterial oxygen saturation. Carboxyhemoglobin and Methemoglobin may erroneously increase SpO2 readings. The level of increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin that is present. Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.

■

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

■

Severe anemia may cause erroneous SpO2 readings.

■

Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.

■

If using pulse oximetry during full body irradiation, keep the sensor out of the irradiation field. If the sensor is exposed to the irradiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period.

■

For home use, ensure that the pulse oximeter’s alarm can be heard from other rooms in the house especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are being operating.

■

Always remove the sensor from the patient and completely disconnect the patient from the pulse oximeter before bathing the patient.

■

Do not place the pulse oximeter where the controls can be changed by the patient.

■

Do not place the pulse oximeter face against a surface. This will cause the alarm to be muffled.

■

Do not place the pulse oximeter on electrical equipment that may affect the pulse oximeter, preventing it from working properly.

■

Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain. Excessive moisture can cause the pulse oximeter to perform inaccurately or fail.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

❚ Increase the separation between the equipment.

❚ Consult the manufacturer for help. ■

A functional tester cannot be utilized to assess the accuracy of the Pulse Oximeter or any sensors.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

iii

table

contents

SECTION 1 - OVERVIEW About this Manual...1-1 Product description...1-3 Features and benefits...1-3 Indications for use...1-3 Pulse oximetry...1-4 General Description...1-4 Principle of Operation...1-4 Functional saturation...1-5 Measured vs. Calculated Saturation...1-5 Masimo SET signal extraction technology...1-5 SECTION 2 - SYSTEM DESCRIPTION Introduction...2-1 Handheld Front Panel...2-2 Handheld back Panel...2-5 Radical standalone...2-6 Standalone Front Panel...2-7 Standalone Back Panel...2-8 Symbols...2-9 Radical monitor interface...2-10 SECTION 3 - SETUP Introduction...3-1 Unpacking and inspection...3-1 Preparation for monitoring...3-1 Radical power requirements...3-1 Initial battery charging...3-2 Initial installation...3-2 Factory Default Settings...3-3 Custom (user) Defined Settings...3-3 Adult/neo (hospital defined) settings...3-4 SatShare Setup...3-5 Philips VueLink setup...3-6 Spacelabs universal flexport setup...3-7 RadNet Setup...3-7 SECTION 4 - OPERATION Introduction...4-1 Basic operation...4-1 General Setup and Use...4-1 Successful SpO2 monitoring...4-3 Masimo Sensors...4-3 Numeric Display - SpO2...4-4 Numeric Display - Pulse Rate...4-4 Signal IQ...4-5 Low Perfusion...4-6 Actions To Be Taken...4-6 Sensitivity...4-7 Touch key control button and icons...4-8 Traditional user interface...4-8 iv

Radical Signal Extraction Pulse Oximeter Operator’s Manual

table

contents

First Page...4-8 Second page...4-8 Simplified user interface...4-9 First page...4-9 Second Page...4-9 Navigating the main menu...4-10 Main menu selection...4-10 Menu categories...4-10 Editing a parameter...4-11 Menu tree...4-11 Alarms...4-13 Display...4-16 General...4-17 Clock...4-17 About...4-17 Config...4-17 Output...4-18 Service...4-20 Trend display...4-21 Navigating the trend display...4-23 First page...4-23 Second page...4-23 Third page...4-23 Trend setup...4-24 Backlight/contrast operation...4-25 Satshare operation...4-26 Home mode operation...4-27 Password operation...4-28 SECTION 5 - ALARMS/MESSAGES Introduction...5-1 Alarm identification...5-1 System messages...5-2 Alarm operation...5-3 Alarm messages...5-3 SECTION 6 - TROUBLESHOOTING Troubleshooting...6-1 SECTION 7 - SPECIFICATIONS Radical specifications...7-1 Performance...7-1 Electrical...7-1 Environmental...7-2 Physical characteristics...7-2 Serial interface specifications...7-3 Serial Printer Setup...7-4 Analog output / nurse call specifications...7-5 Analog Output...7-6 Calibration...7-6 Nurse Call...7-6 Radical Signal Extraction Pulse Oximeter Operator’s Manual

table

contents

SECTION 8 - SENSORS & PATIENT CABLES Introduction...8-1 Masimo SpO2 sensors...8-1 Selecting a Masimo Set Sensor...8-1 Sensor Application Site...8-2 LNOP® Reusable Sensors...8-2 LNOP® Adhesive Sensors...8-2 LNOP® specialty Sensors...8-3 LNOPvTM Adhesive Sensors...8-3 LNCSTM Reusable Sensors...8-3 LNCSTM Adhesive Sensors...8-4 Cleaning And Reuse Of Masimo Sensors...8-4 Reattachment of Single Use adhesive Sensors...8-4 Masimo SET patient cables...8-5 Cleaning And Reuse Of Masimo SET Patient Cables...8-5

About

SECTION 9 - SERVICE AND MAINTENANCE Introduction...9-1 Cleaning...9-1 Battery operation and maintenance...9-2 Replacing the Batteries...9-4 Replacing the Fuses...9-5 Performance verification...9-5 Service and repair...9-9 Repair Policy...9-9 Return Procedure...9-9 Exclusions...9-10 End-user license agreement...9-10 SECTION 10 - ACCESSORIES Accessories...10-1

Radical Signal Extraction Pulse Oximeter Operator’s Manual

overview this

Manual

This manual explains how to set up and use the Masimo SET Radical Pulse Oximeter, herein known as the Radical. Important safety information relating to general use of the Radical appears before this introduction. Other important safety information is located throughout the manual where appropriate.

Read the entire safety information section before you operate the monitor. In addition to the safety section, this manual includes the following sections: SECTION 1

OVERVIEW gives a general description of pulse oximetry.

SECTION 2

SYSTEM DESCRIPTION describes the Radical system and its functions and features.

SECTION 3

SETUP describes how to setup the Radical for use.

SECTION 4

OPERATION describes the operation of the Radical Pulse Oximetry system.

SECTION 5

ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6

TROUBLESHOOTING describes troubleshooting information.

SECTION 7

SPECIFICATIONS gives the detailed specifications of the Radical Pulse Oximeter.

SECTION 8

SENSORS AND PATIENT CABLES outlines how to use and care for Masimo SET sensors and Masimo SET patient cables.

SECTION 9

SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Radical Pulse Oximeter.

SECTION 10

ACCESSORIES lists the available Radical accessories.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

1-1

overview Warnings,

cautions

and

notes

Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning: WARNING: THIS IS A SAMPLE 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. Sample of Caution: CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when extra general information is applicable. Sample of Note:

NOTE: This is a sample of a Note.

overview Product

description

The Radical Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. The Radical can be used as either a Handheld or a Standalone monitor. The Radical features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values for SpO2, pulse rate, plethysmographic waveform and Signal Identification and Quality Indicator (Signal IQTM). The Radical can be used to interface with a multiparameter patient monitor to provide Masimo SET pulse oximetry information to that monitor for display. FEATURES AND BENEFITS ■ Clinically proven as the highest sensitivity and specificity pulse oximeter in the world ■ Signal IQ ® waveform for signal identification and quality indication during excessive motion and low signal to noise situation ■ FastSat ® tracks rapid changes in arterial O2 with high fidelity unlike any other pulse oximeter ■ FastStartTM allows for rapid measurement from the time the instrument is first turned on ■ APODTM (Adaptive Probe Off Detection) offers the best probe off detection of Masimo's three sensitivity modes - APOD, Normal and MAX sensitivity ■ ClearVueTM technology delivers the highest resolution display available ■ SmartToneTM beeps in sync with pulse, and with tonal changes for every 1% drop in saturation, even under most patient motion conditions ■ SatShare ® interface connection to existing multiparameter monitor (models RDS1/1B only) ■ RS-232, analog output, and nurse call interfaces (models RDS-1/1B and RDS-3 only) ■ User configurability maximizes operation for all applications ■ Facilitates economical sensor standardization throughout the hospital ■ SpO2, pulse rate, alarm, trending, perfusion index, Signal IQ and plethysmographic waveform display ■ Automatic screen rotation provides upright display for vertical or horizontal monitor positioning (not available on the RDS-2 model) ■ Remote alarming interface ■ Designed for hospital, transport and home use ■ Up to thirty days of trending INDICATIONS FOR USE The Radical and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Radical and accessories are indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile and home environments. In addition, the is indicated to provide continuous noninvasive monitoring data to validated multiparameter patient monitors* for display on those monitors. *Contact Masimo for the latest list of SatShare validated multiparameter monitors.

1-2

Radical Signal Extraction Pulse Oximeter Operator’s Manual

1-3

overview Pulse

oximetry

overview

FUNCTIONAL SATURATION

GENERAL DESCRIPTION Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor is connected to the pulse oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in three ways: 1. As a percent value for arterial oxygen saturation (SpO2) 2. As a pulse rate (PR) 3. As a plethysmographic waveform The following figure shows the general monitoring setup. 1

1. Instrument 2. Patient Cable 3. Sensor

The Radical is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. MEASURED VS. CALCULATED SATURATION Oxygen measurements that can be obtained from the Radical are commonly compared to invasive measurements obtained from blood gas samples. When comparing invasive and noninvasive measurements and interpreting values, caution should be used, as the calculated values obtained from the blood gas sample may differ from the SpO2 measurements of the pulse oximeter. Different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. As blood gas samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the core oxygen saturation of the patient is stable and not changing over the period of time that the blood gas sample is taken.

PRINCIPLE OF OPERATION Pulse oximetry is governed by the following principles: 1.

Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).

The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. The Radical Pulse Oximeter uses a two-wavelength pulsatile system to distinguishbetween oxygenated and deoxygenated blood. Signal data is obtained by passing red(rd)(660 nm wavelength) and infrared (ir)(905 nm wavelength) light through a vascular bed (for example a fingertip, a hand, a foot) and measuring changes in light absorption during the pulsatile cycle. This information may be useful to clinicians. The radiant power of the light is rated at 0.79mW (max.). See figure below. The Radical utilizes a sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a photodiode (photodetector). The photodetector receives the light, converts it into an electronic signal and sends it to the Radical for calculation.

MASIMO SET SIGNAL EXTRACTION TECHNOLOGY Masimo Signal Extraction Technology’s signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the nonarterial blood also moves, which causes conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform® (DST)®, reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.

LED's

Recessed Photo Detector

Once the Radical receives the signal from the sensor, it utilizes Masimo SET signal extraction technology for calculation of the patient’s functional oxygen saturation and pulse rate. 1-4

Radical Signal Extraction Pulse Oximeter Operator’s Manual

1-5

overview

system

description

Introduction

Masimo SET Parallel Engines

Radical provides the functionality of three pulse oximeters in one: R/IR (Conventional Pulse Oximetry)

R/IR

Adaptive Filter with DSTTM

MEAS

■

The Radical is a fully featured Handheld pulse oximeter

CONF

■

The Radical is a fully featured standalone pulse oximeter

■

The Radical interfaces to the SpO2 input module of multiparameter patient monitors* to upgrade conventional pulse oximetry technology to Masimo SET technology.

Post Processor MEAS CONF

Digitized, Filtered & Normalized

MEAS SSTTM

CONF

Confidence Based Arbitrator

Saturation

MEAS Proprietary Algorithm 4

The Handheld oximeter snaps into the Radical Docking Station to provide a fully featured standalone pulse oximeter. The Docking Station connects to AC power for standalone operation or charging of the Handheld. An optional Docking Station battery is available. The standalone Radical features nurse call, analog output and interfaces to serial printers.

CONF

MEAS Proprietary Algorithm 5

The Handheld portion of the Radical contains the majority of the pulse oximeter features. All pulse oximetry measurement information, as well as device status data is displayed on the Handheld LCD screen. All user input is handled through the control buttons on the front panel. The sensor cable connector is located on the Radical Handheld oximeter.

CONF

Utilizing a SatShareTM cable, the standalone Radical also interfaces with the SpO2 input of a validated multiparameter patient monitor*, instantly upgrading the conventional pulse oximetry to Masimo SET pulse oximetry. The SatShare cable attaches to the back of the Radical Docking Station, and SatShare cables are available to interface with most multiparameter patient monitors*.

Masimo SET DST

CAUTIONS: ■

THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE RADICAL DISPLAY FOR PATIENT WAVEFORM.

■

IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR

■ ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED. Refer to Section 3, SatShare Setup and Section 4, SatShare Operation for additional details. *Contact Masimo for the latest list of SatShare validated multiparameter monitors. 1-6

Radical Signal Extraction Pulse Oximeter Operator’s Manual

2-1

system Radical

description

system

handheld

The Handheld Radical provides most of the functionality of the pulse oximeter. All user input and displays are controlled by this part of the Radical system. The sensor cable connects into the swivel connector on the Handheld unit. The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pulse Oximeter for spot checks.

Pleth + Signal IQ View 3 1

4 No Sensor

Masimo SET FastSat

100 85 %SpO2 140 50 BPM

22 21 20

HPO1

19 18

16 15 14 13

ALARM STATUS INDICATOR

SYSTEM MESSAGE AREA

The system messages generated by the instrument are displayed in the System Message Area. See Section 5, System messages.

160 40

11:42:46

SENSITIVITY

BATTERY STATUS INDICATORS

TOUCH KEY CONTROL BUTTONS

SPEAKER

BPM

03/27/03

2-2

Max APOD

Masimo SET

%SpO2

Radical Signal Extraction Pulse Oximeter Operator’s Manual

Press down the Handheld Release Button and pull the Handheld device off the Docking Station.

The alarm status indicator (a bell) can be shown with or without a slash. It flashes when an alarm condition is present. When the alarm is silenced using the Alarm Silence Button, an alarm status indicator with a slash and a timer is shown to indicate that the alarm is temporarily silenced. When the alarm is silenced through All Mute menu selection, which is permanent until power is cycled or deselected using menu, an alarm status indicator with a slash is shown to indicate that alarm has been silenced.

The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO2. The upper and lower SpO2 alarm limits are also displayed next to the SpO2 measurement. When a SpO2 sensor is not connected to a patient and during pulse search, the MEASUREMENT display will show dashed lines. When the measured value is outside of the alarm limits, the SpO2 Measurement Display DISPLAY flashes and an alarm will sound. The oxygen saturation is calculated and the display is updated at a frequency of once per second. The Masimo SET symbol is shown on the Radical display when SET processing is active. Masimo MASIMO SET Note: Patient information, not Masimo SET, will be displayed SET when using a RadNet compatible unit connected to a RadNet central station. The FastSat symbol is shown on the Radical display whenever the FastSat FASTSAT Radical is set to operate in the FastSat mode. SATURATION The Saturation Alarm Limits Display shows the upper and lower ALARM LIMITS saturation alarm limits. When an alarm limit is reached or exceeded, the SpO2 value and the violated limit flashes. DISPLAY

06:10:23pm 03/27/03

Numbers View

100 85

HANDHELD RELEASE BUTTON

HANDHELD FRONT PANEL The following figure and corresponding text outline all the features of the Handheld Radical:

description

The Max or APOD sensitivity icon is shown on the Radical display to indicate if the Radical is set to operate in Normal sensitivity, Maximum sensitivity or Adaptive Probe Off Detection mode.When in Normal mode, this area will appear blank. The Battery Status Indicators show the capacity of the Radical Handheld and optional Docking Station batteries. The indicator flashes when less than 15 minutes of battery life is left and the battery needs to be recharged. The Docking Station Battery Status indicator is not shown when the optional Docking Station battery is not present. Press a Touch Key Control Button to select the corresponding touch key icon. See Section 4, Touch Key Control Buttons and Icons for more details.

The speaker indicates audio alarms. Care should be taken not to cover the speaker and muffle the audible alarm volume. Connect the patient cable to the Handheld Radical by plugging PATIENT CABLE the cable into the Patient Cable Connector. Use only Masimo compatible sensors and cables with this oximeter. See Section 8, CONNECTOR Sensors and Patient Cables for more details.

TOUCH KEY ICONS

The Touch Key Icons indicate the software menu items that can be selected through the Touch Key Control Buttons. Pressing a Touch Key Control Button next to an icon selects the option.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

2-3

Philips Vuelink

PERFUSION INDEX

The Perfusion Index indicates numerically the percentage of pulsatile signal to non-pulsatile signal (pulse strength)

PULSE RATE ALARM LIMITS DISPLAY

PULSE RATE

The Pulse Rate Alarm Limits Display shows the upper and lower pulse rate alarm limits. When an alarm limit is reached or exceeded, the pulse rate value and the violated limit flashes. The Pulse Rate Measurement Display shows the patient’s pulse rate in beats per minute. The upper and lower pulse rate alarm limits are also displayed next to the pulse rate measurement. The pulse rate is calculated and the display is updated at a frequency of once per second.

2-4

Radical Signal Extraction Pulse Oximeter Operator’s Manual

description

HANDHELD BACK PANEL The Handheld back panel features the interconnection to the Docking Station, an accessory mount for the pole clamp accessory and access to the Handheld battery pack.

1251 0000 536

The Signal IQ shows the acquired signal quality and the timing of the pulse. A tall vertical line indicates a high quality signal, while a small vertical line indicates a low quality SIGNAL IQ signal. The Signal IQ may also be shown as a single, pulsating bar. The Pulse Waveform Display shows the acquired plethysmograph waveform.The pleth waveform is scaled with PULSE signal strength. Signal strength is defined as the relation of WAVEFORM arterial pulsatile signal to the non-pulsatile signal DISPLAY component. The Time and Date Indicator displays the current time and TIME AND DATE date. The time is displayed in 12 or 24 hour format. The date is displayed in dd/mm/yy or mm/dd/yy format. Select the date INDICATOR and time display formats in the Clock menu. Press the Backlight Button to change the illumination level of the backlight. With the AC line power connected, four levels of illumination are available (in addition to the no illumination level). In the Handheld mode, three levels of illumination are BACKLIGHT/ available (again in addition to the no illumination level). Use CONTRAST the lowest illumination for most efficient battery usage. The BUTTON backlight Button is also used to change the contrast of the LCD display. Press and hold the Backlight Button for longer than six seconds to change the contrast. Release the Backlight Button at the desired contrast setting. Press the Alarm Silence Button to temporarily silence patient and low battery alarms. Press the Alarm Silence Button when the SENSOR OFF or NO SENSOR messages are flashing (i.e. the sensor is removed from the patient) to acknowledge the end of monitoring. In these states, all ALARM further alarms are suspended until the pulse oximeter starts SILENCE measuring SpO2 and pulse rate again. BUTTON Note: System failure alarms can be silenced by pressing the Power/Standby or Alarm Silence Button. If the Power/Standby Button does not silence the system fault alarm, press the Alarm Silence Button. The Output Mode Indicator displays the output mode selected by the user (Philips Vuelink or Spacelabs Flexport). The Output Mode Indicator also displays the type of OUTPUT MODE SatShare® cable. The Output Mode Indicator is only displayed when the Radical device actively outputs data INDICATOR other than ASCII text, or interfaces with a monitor through the SatShare cable. The Output Mode Indicator will take place of the Time and Date indicator when utilized. Press the Power/Standby Button to turn the instrument on. POWER/STAND Press, hold the button for more than 2 seconds and then BY BUTTON release the button to turn the instrument off.

system

11328/2269M-0805

description

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare® feature are also covered by U.S. Patent 6,770,028. Other patents pending.

system

MEDICAL ELECTRICAL EQUIPMENT UL 2601-1/CAN/CSA C22.2 No. 601.1 80FK

DOCKING STATION CONNECTOR

The Radical Handheld interfaces with the Docking Station through this connector.

POLE CLAMP ACCESSORY HOLDER

The optional Pole Clamp accessory attaches to this holder. See the Directions for Use of the Pole Clamp accessories for attachment instructions.

BATTERY PACK

The Radical Handheld is powered by a NiMH battery located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

2-5

system Radical

description

standalone

When the Radical Handheld is placed into the Docking Station, the Radical becomes a full-featured standalone device. The Radical Standalone acts as a battery charger for the Handheld device and has AC power connection capabilities. The Standalone can also interface to serial devices, nurse call or analog output devices, and multiparameter patient monitors through a SatShare cable.

system

description

STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical Standalone device.

There are several models of Docking Stations available. The following table outline which features are available for each model of Docking Station.

Masimo SET FastSat

RDS-1 RDS-1B RDS-2 RDS-3 RDS-3B

RDS-4

AC Power Input

■

SatShare Interface

■

Serial RS-232 Interface

■

Nurse Call/Analog Output Interface

■

140 50 BPM

■

Docking Station Battery Charging Indicator

■

Handheld Battery Charging Indicator

■

Red Alarm Indicator

■

AC Power Indicator

■

Docking Indicator

■

Handheld Battery Deep Discharge Support Docking Station Battery Deep Discharge Support

■

03/27/03

DOCKING STATION BATTERY CHARGING INDICATOR

The Docking Station Battery Charging Indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging. The charging indicator does not illuminate when the battery is fully charged or when the battery is not present.

HANDHELD BATTERY CHARGING INDICATOR

The Handheld Battery Charging Indicator is illuminated when the Handheld battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present.

VISUAL ALARM INDICATOR

The Visual Alarm Indicator is illuminated when an alarm condition is active and the Alarm Status Indicator is shown.

AC POWER INDICATOR

The AC Power Indicator is illuminated when the Radical Docking Station is plugged into AC line power.

DOCKING INDICATOR

The Docking Indicator is illuminated when the Handheld unit is turned on and is properly interfaced to a Docking Station.

■

Automatic Display Rotation Support (Gravity Detector)

11:42:46

■

12-hour Extended Battery

■

Check Sensor

100 85 %SpO2

DOCKING STATION FEATURES

NOTE: When the Radical Standalone is turned on, all indicator LEDs initially turn on and off at start up.

The RDS-1 and RDS-3 are optionally available with RadNet capability. (Refer to Section 3 RadNet Setup for details).

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Radical Signal Extraction Pulse Oximeter Operator’s Manual

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system

description

NOTE: Some of the interfaces and symbols are not available in all versions of the Docking Station.

SYMBOLS

MEDICAL ELECTRICAL EQUIPMENT UL 60601-1/CAN/CSA C22.2 No. 601.1 80FK

Rx Only

description

SYMBOLS The following symbols are found on the Radical unit, Docking Station or packaging and are defined below:

STANDALONE BACK PANEL

system

DEFINITION RS-232

Manufactured by: Masimo Corporation Irvine, CA 92618 USA Made in USA

SatShare interface Equipotential Ground Terminal

See Instructions for Use

SERIAL OUTPUT CONNECTOR

Use the Serial Output Connector with a ferrite bead installed to connect a serial device, including a serial printer, RadNet Interface Module or PC, to the Radical. The data is provided in standard RS232C format. See Section 7, Serial Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant.

ANALOG OUTPUT / NURSE CALL CONNECTOR

Use the Analog Output Connector with a ferrite bead installed to interface with an analog output device, such as a chart recorder or nurse call system. All external device connections to the Analog Output / Nurse Call Connector must be IEC-60950 compliant.

SATSHARE CABLE CONNECTOR

Use the SatShare Cable Connector to connect a SatShare cable to the SpO2 input connector of a multiparameter patient monitor. All external device connections to the SatShare Cable Connector must be IEC-60601-1 compliant. SatShare cables are available to interface with most major multiparameter patient monitors. Check the label on the SatShare cable and the SatShare Directions for Use to ensure that the correct cable is used for each type of patient monitor. Refer to the Masimo web site at www.masimo.com for the latest SatShare cables and validated instruments.

POWER ENTRY MODULE

EQUIPOTENTIAL GROUND CONNECTOR

The power entry module contains the input connector for AC power and two fuses. The AC input provides power to the system from the AC line. Always connect the pulse oximeter to the mains power for continuous operation and/or battery recharging. NOTE: Use the power cord as the means to disconnect the device from the mains power supply.

Fuse Replacement Analog Out Interface Nurse Call Interface WEEE Compliant Mark of Conformity to European Medical Device Directive 93/42/EEC

Rx ONLY

Federal law restricts this device to sale by or on the order of a physician (USA audiences only) Underwriter's Laboratories Inc. approved

NON STERILE 5%-95% RH

+70 C

-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg

Storage humidity range: 5% to 95% Storage temperature range: +70C to -40C Storage altitude range: +1600hPa to +500hPa Keep dry Fragile/breakable, handle with care

Use the Equipotential Ground Connector for grounding.

Year of Manufacture

IPX1

Protection against liquid drops falling vertically. Defibrillation Proof Type BF

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Radical Signal Extraction Pulse Oximeter Operator’s Manual

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system Radical

monitor

description interface

In addition to being a full-featured Handheld and Standalone Pulse Oximeter, Radical’s unique SatShare interface links the Radical to most existing multiparameter patient monitors through the pulse oximetry patient cable or SpO2 input connector.

setup Introduction Before the Radical Pulse Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be fully charged. Unpacking

and

inspection

Remove the instrument from the shipping carton and examine it for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Technical Service Department. The contact address and phone numbers are listed in Section 9, Service and Repair. Preparation ■

Upgrades any approved and validated monitor to Masimo SET performance by using the calculated SpO2 and pulse rate determined by Radical to simulate an ideal waveform, which is sent to the validated multiparameter patient monitor.

■

Connects into the SpO2 patient cable or SpO2 input connector of the multiparameter patient monitor. Refer to Section 3, SatShare Setup and Section 4, SatShare Operation for additional details. CAUTION: THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL. REFER TO THE RADICAL DISPLAY FOR THE PATIENT WAVEFORM. CAUTION: ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.

for

monitoring

The following sections of the manual describe the preparation, set-up and initial installation of the Radical Pulse Oximeter. RADICAL POWER REQUIREMENTS Always use a hospital grade, AC power cable to connect the Radical Pulse Oximeter to an AC power source. Do not connect the Radical Pulse Oximeter Docking Station to an AC outlet controlled by a switch. Verify the AC power voltage and frequency before use. Verify that the power source can provide adequate power rating as indicated on the rear panel of the Radical Docking Station. The Radical Pulse Oximeter is designed to operate on 100 to 240VAC, 47-63 Hz. The device is rated at 55 VA max. Connect a hospital grade power cable to the power entry module of the Radical unit (IEC-320 connector type at the Radical). Connect the power cable to an AC power source. Ensure that the unit is adequately powered by verifying that the AC power indicator on the Docking Station is illuminated. CAUTION:

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Radical Signal Extraction Pulse Oximeter Operator’s Manual

■

CONNECT THE OXIMETER ONLY TO A HOSPITAL-GRADE RECEPTACLE.

■

DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR FROM THE POWER PLUG.

■

DO NOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE. THE POWER CORD AND PLUG MUST BE INTACT AND UNDAMAGED.

■

USE THE POWER CORD AS THE MEANS TO DISCONNECT THE DEVICE FROM THE MAINS POWER SUPPLY.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

3-1

setup ■

IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY FUNCTIONAL.

■

TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS.

■

DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR DIMMER.

Monitor

setup

The Radical maintains three types of default values which will automatically reverts to after a power cycle: ■ Factory – these options are restored to factory values ■ Custom – these settings can be changed by the user and retained through the power cycle. ■ Adult / Neo – these settings can be selected to revert to factory or hospital-defined values (for Adult or Neonatal) after a power cycle. The following outlines the default values the Radical reverts to after a power cycle.

INITIAL BATTERY CHARGING Before use, the Radical Handheld battery and the optional Docking Station battery needs to be fully charged.

FACTORY DEFAULT SETTINGS

To charge the batteries, attach the Handheld unit to the Docking Station and plug in the AC power cord. Verify that the batteries are charging. The battery charging LED indicators on the Docking Station flash prior to charging and remain illuminated while the batteries are charging.

LCD SCREEN ILLUMINATION AC Power Battery Power

Set to maximum, level 4 Set to off

Refer to Section 9, Battery Operation and Maintenance, for proper battery charging.

SENSITIVITY

Set to normal mode

INITIAL INSTALLATION Place the Docking Station on a stable hard flat surface near the patient. Always place the Radical unit on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical Standalone unit. Make sure that Radical loudspeaker is not covered to avoid a muffled alarm sound.

3-2

setup

OPTION

DEFAULT SETTING

CUSTOM (USER) DEFINED SETTINGS This mode is indicated by “Mode Custom” on the Alarms menu. The following table outlines the settings that may be changed by the user and the Radical will remember after a power cycle.

The Radical Handheld, Docking Station or Standalone should not be operated outside the following environmental conditions:

OPTION

DEFAULT SETTING

DISPLAY VIEW AND CONTRAST

Set to pre-power down setting

OPERATING ENVIRONMENTAL CONDITIONS

AVERAGING TIME

Set to pre-power down setting

TEMPERATURE

+5°C to +40°C, +41°F to +104°F

FASTSAT

Set to pre-power down setting

HUMIDITY

5% to 95%, non-condensing

HOME USE

Set to pre-power down setting

OPERATING ALTITUDE

1060 mbar to 500 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m)

INTERFACE ALARMS

Set to pre-power down setting

SATSHARE NUMBERS

Set to pre-power down setting

POWER SAVE

Set to pre-power down setting

DATE AND TIME FORMAT

Set to pre-power down setting

LANGUAGE

Set to pre-power down setting

ANALOG OUTPUT

Set to pre-power down setting

SERIAL OUTPUT PORT MODE

Set to pre-power down setting

Radical Signal Extraction Pulse Oximeter Operator’s Manual

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setup

OPTION

DEFAULT SETTING

PULSE BEEP VOLUME

Set to pre-power down setting

TREND DISPLAY PARAMETERS

Set to pre-power down setting

TREND PERIOD

Set to pre-power down setting

LOW SpO2 ALARM LIMIT

Set to pre-power down setting

setup

SATSHARE SETUP 1. Select the SatShare cable that is appropriate for the multiparameter monitor that is being connected. Check the Masimo web site at www.masimo.com for the latest list of available SatShare cables and validated instruments.

ADULT/NEO (HOSPITAL DEFINED) SETTINGS The following table outlines settings that may be defined by the hospital. If enabled (via a password protected screen), these settings will return to pre-defined values after a power cycle. This mode is indicated by “Mode Adult” or “Mode Neo” on the Alarms menu. See Section 4, Output, for details on enabling and setting these parameters. 2.

Connect the labeled end of the cable to the SatShare Cable Connector port on the back of the Docking Station. Tighten the connector screws for a secure connection.

Connect the other end of the SatShare cable either to the sensor connector of the multiparameter monitor’s SpO2 cable or directly to the SpO2 connector on the monitor.

Verify that the Radical recognizes the correct cable. The name of the SatShare cable will be displayed on the LCD screen when the SatShare mode is functional.

Set the multiparameter monitor’s high and low saturation and pulse rate alarm limits as appropriate.

Set the multiparameter monitor's averaging time to the lowest setting (i.e. fastest response). The Radical's ideal waveform obviates the need for additional averaging by the monitor. If the multiparameter monitor's averaging time is not changed, the time to display physiological changes in saturation on the monitor will be increased with SatShare. However, the delay can be minimized by reducing the multiparameter monitor's averaging time.

While in the SatShare mode, if there are any significant discrepancies between the readings from the Radical and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical are to be considered the correct values.

The SatShare feature provides an ideal, simulated waveform corresponding to the measured saturation and pulse rate values determined by the Masimo SET technology. This waveform may be used to display these values on multiparameter monitors through the multiparameter monitor’s oximetry sensor or input connector.

To use the Radical with SatShare while it is not connected to AC power, set the Power Save parameter in the General menu to "No", refer to Section 4, Operation. Please note that if the Radical is used in this mode, the length of time the Radical can operate on battery power will be significantly diminished.

It is recommended that the Radical is positioned close to the multiparameter monitor with the Radical screen visibly displaying the plethysmographic waveform and the saturation and pulse rate measurements.

Set the SatShare Numbers and the Interface Alarms parameters in the General menu according to Customer preference.

OPTION

CUSTOM SETTING

SpO2 HIGH/LOW ALARM LIMIT

Set to pre-power down setting

PULSE RATE HIGH/LOW ALARM LIMIT

Set to pre-power down setting

ALARM SILENCE

Set to 120 seconds

ALARM VOLUME

Set to pre-power down setting

ALARM DELAY

The 0 and 5 second setting is retained, the 10 second setting is set to 5 seconds

Satshare

ADULT / NEO SETTING (PRE DEFINED)

Set to pre-defined Adult or Neo setting

setup

The Radical Pulse Oximeter has been proven to be accurate during patient motion and low perfusion conditions. Saturation and pulse rate values from the Radical may be displayed on a multiparameter monitor through the SatShare feature.

CAUTION: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED. 3-4

Radical Signal Extraction Pulse Oximeter Operator’s Manual

10. If displaying the simulated waveform is not desirable, it is recommended to turn off the pleth waveform display of the multiparameter patient monitor. Radical Signal Extraction Pulse Oximeter Operator’s Manual

3-5

setup

CAUTIONS: ■

■

SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL WAVEFORMS. THE MULTIPARAMETER PATIENT MONITOR DECODES THESE SIGNALS INTO SATURATION AND PULSE RATE VALUES. DURING SATSHARE OPERATION, THE AUDIBLE ALARMS MAY BE MUTED ON RADICAL. WHEN THE AUDIBLE ALARM IS MUTED (INDICATED BY THE BELL WITH A SLASH THROUGH IT) ON RADICAL, USE THE MULTIPARAMETER MONITOR FOR AUDIBLE ALARM INDICATION. DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES. INSTEAD, USE THE PLETH WAVEFORM DISPLAYED ON THE RADICAL SCREEN. TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL PULSE OXIMETER IS CONNECTED TO THE AC MAINS POWER SUPPLY. TO ENSURE THAT THE SAFETY LEVEL DURING DEFIBRILLATION IS MAINTAINED, MAKE SURE THAT THE SATSHARE CABLE CONNECTOR IS PROPERLY SECURED AT THE DOCKING STATION.

Philips

VueLink

setup

CAUTION: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED.

3-6

Select the Philips VueLink selection from the Output menu on the Radical. Refer to Section 4, Output.

Connect one end of the VueLink cable to the Serial Output connector on the back of the Docking Station.

The Radical Pulse Oximeter can be set up to audibly indicate all patient alarms while communicating with the Philips module. Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical.

Spacelabs

universal

flexport

setup

CAUTION: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED. 1.

Select the Spacelabs Flexport selection from the Output menu on the Radical.

Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the back of the Docking Station.

Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal Flexport connector.

The SpO2 and pulse rate values will automatically appear on the Spacelabs screen.

In order for the pleth waveform to be displayed on the Spacelabs screen and for the Spacelabs monitor to indicate the alarm conditions measured by the pulse oximeter, the user must configure the Spacelabs monitor. Please see the Spacelabs monitor Operator’s manual for complete instructions.

The Radical can be set up to audibly indicate all patient alarms while communicating with the Spacelabs Flexport module. Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical.

ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED. WARNING: EXTERNAL DEVICE CONNECTIONS TO THE SATSHARE PORT MUST BE IEC-60601-1-1 COMPLIANT.

setup

RadNet

setup

CAUTION: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED.

NOTE: Confirm that the Radical Docking Station is RadNet Ready before preceeding. 1.

Select the ASCII 2 selection from the Output menu on the Radical.

Connect one end of the serial cable to the Serial Output connector on the back of the Docking Station.

Connect the other end of the serial cable to the RadNet Interface Module connector.

Turn the RadNet Interface Module on.

Connect the other end of the VueLink cable to the VueLink module and insert the module into the Philips monitor rack.

The SpO2 and pulse rate values will automatically appear on the RadNet Central Station Monitor screen.

The SpO2 and pulse rate values will automatically appear on the Philips monitor.

In order for the pleth waveform to be displayed on the Philips monitor and for the Philips monitor to indicate the alarm conditions measured by the pulse oximeter, the user must configure the Philips monitor. Please see the Philips Operator’s manual for complete instructions.

In order for the pleth waveform to be displayed on the RadNet Central Station Monitor screen and for the RadNet Central Station Monitor monitor to indicate the alarm conditions measured by the pulse oximeter, the user must configure the RadNet Central Station monitor. Please see the RadNet Hardwired and Wireless Systems Operator’s Manual for complete instructions.

Radical Signal Extraction Pulse Oximeter Operator’s Manual

3-7

setup

The Radical can be set up to audibly indicate all patient alarms while communicating with the RadNet Interface module. Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical.

CAUTION: REMOVING THE RADICAL HANDHELD FROM THE RADNET READY DOCKING STATION WILL CAUSE LOSS OF COMMUNICATION TO THE RADNET CENTRAL MONITORING STATION. THEREFORE, WHEN BEING USED WITH THE RADNET INTERFACE MODULE, THE HANDHELD LOCKING FEATURE SHOULD BE UTILIZED.

operation

Introduction To operate the Radical effectively, the device must be set up properly, and the operator must: ■ Know how the pulse oximeter derives its readings (see Section 1, Pulse Oximetry). ■ Be familiar with its controls, components and operation. ■ Understand its status and alarm messages (see Section 5, Alarm Identification, System Messages and Section 6, Troubleshooting). Basic

operation

GENERAL SETUP AND USE 1.

Inspect the oximeter case for damage.

Connect the patient cable to the Patient cable connector of the Radical. Make sure it is a firm connection and the cable is not twisted, sliced or frayed.

Ensure that the power cord is plugged into the Power Entry Module of the oximeter and into the AC power.

Select a sensor that is compatible with the oximeter before connecting it to the patient cable. See section 8, Sensors and Patient Cables. If using a single patient adhesive or disposable sensor, check that the emitter (red light) and the photodetector are properly aligned. Remove any substances that may interfere with the transmission of light between the sensor’s light source and photodetector.

Attach the sensor to the patient. Refer to the Directions for Use of the sensor.

Connect the sensor to the unit (or patient cable) with the logos lining up; make sure it is a firm connection.

Press the Power/Standby button to turn the oximeter on.

Make sure the display window is free of alarm and system failure messages (see Section 5, Alarm Identification).

On the display, verify ■

The high and low alarm limits for SpO2 and pulse rate.

■ The readings for SpO2 and pulse rate. NOTE: “-” may appear on the numeric display until the SpO2 and pulse rate readings have stabilized (approximately 10 seconds).

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Radical Signal Extraction Pulse Oximeter Operator’s Manual

4-1

operation

10. Verify that the patient alarms are functional by setting the high and low SpO2 and pulse rate alarm limits beyond the patient readings. ■ An alarm tone sounds. ■

The violated alarm limit and reading flash on the display.

■

The red alarm indicator flashes on the Docking Station (standalone operation).

11. Verify the sensor alarms are functional by removing the sensor from the sensor site. ■

“SENSOR OFF” appears in the message area of the graphic display.

■

The alarm tone sounds.

■

The alarm indicator flashes.

■

Disconnect the sensor from the patient cable or oximeter.

■

Confirm that “NO SENSOR” appears in the message area of the graphic display.

Successful

SpO2

monitoring

The following general points will aid in ensuring oximetry monitoring success. ■ Place the sensor on a site that has sufficient perfusion and provides proper alignment of the LED’s and photodetector. ■ Place the sensor on a site that has unrestricted blood flow. ■ Do not constrict the monitoring site when securing a sensor with tape. ■ Do not select a site near potential electrical interference (electrosurgical unit, for example). ■ Read the sensor Directions for Use for proper sensor application. MASIMO SENSORS Before use, carefully read the pertinent sensor Directions for Use.

■

Create an alarm condition by lowering the SpO2 or pulse rate high alarm limits beyond the patient readings.

Use only Masimo oximetry sensors for SpO2 measurements. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.

■

Press the Alarm Silence button.

CAUTIONS:

■

The alarm tone ceases for the displayed amount of time.

12. Verify alarm silence operation.

■

DO NOT USE DAMAGED SENSORS. DO NOT USE A SENSOR WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS.

■

DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE.

■

DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM.

13. To begin patient monitoring: ■

Adjust the alarm limits.

■

Adjust the alarm volumes.

■

Adjust the pulse beep volume.

14. Verify the sensor is on correctly and that the measured data is appropriate, see Section 4, Successful SpO2 Monitoring. 15. Monitor the patient. 16. After monitoring is complete, remove the sensor from the patient and store or dispose of the sensor according to governing rules. See the Directions for Use of the sensor. 17. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off.

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operation

Radical Signal Extraction Pulse Oximeter Operator’s Manual

4-3

operation

NUMERIC DISPLAY - SpO2 Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide a good feeling for changes that are artifactual or physiological and the speed, timing, and behavior of each.The stability of the readings over time is affected by the averaging mode being used. The longer the averaging time, the more stable the readings tend to become. This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times. However, longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and PR. NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Radical may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times.There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable. The pulsations from intra-aortic balloon support can be additive to the pulse rate displayed on the pulse oximeter.

operation

SIGNAL IQ The Radical display provides a visual indicator of the plethysmogram signal quality and an alert when the displayed SpO2 values are not based on adequate signal quality. The signal quality indicator displayed on the Radical is called the Signal IQ.The Signal IQ can be used to identify the occurrence of a patient's pulse and the associated signal quality of the measurement. With motion, the plethysmographic waveform is often distorted and may be obscured by artifact. The Signal IQ, shown as a vertical line, coincides with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Radical locates the arterial pulsation. The pulse tone (when enabled) coincides with the vertical line of the Signal IQ. The height of the vertical line of the Signal IQ indicates the quality of the measured signal. A high vertical bar indicates that the SpO2 measurement is based on a good quality signal. A small vertical bar indicates that the SpO2 measurement is based on data with low signal quality. When the signal quality is very low the accuracy of the SpO2 measurement may be compromised, and a “Low Signal IQ” message is displayed in the message area on the Radical display. When the "Low Signal IQ" message appears proceed with caution and do the following: ■ Assess the patient. ■ Check the sensor and ensure proper sensor application. The sensor must be well secured to the site for the Radical to maintain accurate readings. Also, misalignment of the sensor's emitter and detector can result in smaller signals. ■ Determine if an extreme change in the patient's physiology and blood flow at the monitoring site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion, sampling of an arterial blood specimen from the hand containing the pulse oximetry sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia, medications, or a spell of Raynaud's syndrome.) ■ With neonates or infants, check that the peripheral blood flow to the sensor site is not interrupted. Interruption, for example, may occur while lifting or crossing their legs, during a diaper change. After performing the above, if the "Low Signal IQ" message is displayed frequently or continuously obtaining an arterial blood specimen for CO-Oximetry analysis may be considered to verify the oxygen saturation value.

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Masimo

Radical and Radical 7

Radical Operators Manual Aug 2007