Operator's Manual
49 Pages
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signal extraction pulse oximeter OPERATOR’S
MANUAL
Signal Extraction Pulse Oximeter OPERATOR’S
MANUAL
The Radical-7 Operating Instructions provide the necessary information for proper operation of all models of the Radical-7 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-7 Pulse Oximeter are a prerequisite for its proper use. Do not operate the Radical-7 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 Burckhardtstrasse 1 30163 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. © 2006 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, Satshare, SET, LNOP, LNCS and LNOPv are federally registered trademarks of Masimo Corporation. Radical-7, Rainbow, RadNet, RadicalScreen, Signal IQ, FastSat, FastStart and APOD are trademarks of Masimo Corporation.
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
i
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical-7 Signal Extraction Pulse Oximeter’s 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. ■
ii
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.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ ■
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 or cable is damaged in any way, discontinue use immediately.
■
The Pulse Oximeter Module can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.
■
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:
■
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 and understood 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.
■
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
❚ Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.
■
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.
❚ Consult the manufacturer for help.
■
Interfering Substances: Carboxyhemoglobin and Methemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.
■
Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
■
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 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.
■
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. Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
❚ Reorient or relocate the receiving device. ❚ Increase the separation between the equipment.
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
iii
table
of
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 vs. fractional saturation...1-5 Measured vs. Calculated Saturation...1-5 Masimo set signal extraction technology...1-5 SECTION 2 - SYSTEM DESCRIPTION Introduction...2-1 Radical-7 handheld...2-2 Handheld Front Panel...2-2 Handheld back Panel...2-5 Radical-7 standalone...2-6 Standalone Front Panel...2-7 Standalone Back Panel...2-8 Symbols...2-9 Radical-7 monitor interface...2-9 SECTION 3 - SETUP Introduction...3-1 Unpacking and inspection...3-1 Preparation for monitoring...3-1 Radical-7 power requirements...3-1 Initial battery charging...3-2 Initial installation...3-2 Monitor setup...3-3 Factory Default Settings...3-3 Custom (user) Defined Settings...3-3 Adult/neo (hospital defined) settings...3-4 Satshare setup...3-4 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 Numeric Display - SpO2...4-3 Masimo Sensors...4-3 Numeric Display - Pulse Rate...4-4 Signal IQ...4-4 Low Perfusion...4-5 Actions To Be Taken...4-5 Touch key control button and icons...4-6 iv
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
table
of
contents
Traditional user interface...4-6 First Page...4-6 Second page...4-6 Simplified user interface...4-8 First page...4-8 Second Page...4-8 Navigating the main menu...4-9 Main menu selection...4-9 Menu categories...4-9 Editing a parameter...4-10 Menu tree...4-10 Alarms...4-12 Display...4-15 General...4-16 Clock...4-16 Output...4-17 About...4-18 Config...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...4-26 Password operation...4-27 SECTION 5 - ALARMS/MESSAGES Introduction...5-1 Alarm identification...5-1 Alarm operation...5-3 Alarm messages...5-3 System messages...5-4 3D Alarm System option...5-5 Purpose...5-5 3D Alarm System overview...5-5 Desat Index Alarm...5-5 Perfusion Index (PI) Delta alarm...5-5 Desat Index Alarm...5-6 User Interaction to Implement Desat Index Alarm...5-7 Perfusion Index (PI) Delta Alarm...5-8 User Interaction to Implement PI Delta Alarm...5-8 SECTION 6 - TROUBLESHOOTING Troubleshooting...6-1 SECTION 7 - SPECIFICATIONS Radical-7 specifications...7-1 Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
v
table
of
contents
1
overview
Performance...7-1 Electrical...7-1 Environmental...7-2 Physical characteristics...7-2 Serial interface specifications...7-3 Serial Interface Setup...7-4 Serial Printer Setup...7-4 Analog output / nurse call specifications...7-5 Analog Output...7-6 Calibration...7-6 Nurse Call...7-6
About
SECTION 1
OVERVIEW gives a general description of pulse oximetry.
SECTION 8 - SENSORS & PATIENT CABLES Introduction...8-1 Selecting a sensor...8-1 Sensor Application Site...8-1 Masimo SpO2 sensors...8-2 Red Reusable Sensors...8-2 LNOP® Reusable Sensors...8-2 LNOP® Adhesive Sensors...8-2 LNOP® Specialty Sensors...8-3 LNCSTM Reusable Sensors...8-3 LNCSTM Adhesive Sensors...8-3 LNOPvTM Adhesive Sensors...8-3 Sensor Accuracy...8-4 Cleaning And Reuse Of Masimo reusable Sensors and cables...8-4 Reattachment of Single Use adhesive Sensors...8-4
SECTION 2
SYSTEM DESCRIPTION describes the Radical-7 Pulse Oximeter system and its functions and features.
SECTION 3
SETUP describes how to setup the Radical-7 Pulse Oximeter for use.
SECTION 4
OPERATION describes the operation of the Radical-7 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-7 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-7 Pulse Oximeter.
SECTION 10
ACCESSORIES lists the available Radical-7 accessories.
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 Warranty...9-10 Exclusions...9-10 End-user license agreement...9-10
this
Manual
This manual explains how to set up and use the Masimo Rainbow SET Radical-7 Pulse Oximeter, herein known as the Radical-7. Important safety information relating to general use of the Radical-7 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 10 - ACCESSORIES Accessories...10-1
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Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
1-1
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.
overview Product
1
description
The Radical-7 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7 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-7 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 Masimo SET technology performance ■ Applicable for use on neonate, pediatric, infant and adult patients ■ Proven for accurate monitoring in motion and low perfusion environments ■ Universal application: Handheld, Standalone and Patient Monitor Interface
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.
■ Automatic upright display with RadicalScreenTM ■ Signal IQTM for signal identification and quality indication ■ Analog output and nurse call ■ SpO2, pulse rate, alarm, perfusion index, trend and pleth waveform (non-normalized) displays ■ Lightweight design ■ Internal batteries for transport: Standalone -10 hours (optional) Handheld - 4 hours ■ Serial output to printers and PCs ■ RadNetTM capability (only when used with a RadNetTM Ready Docking Station) INDICATIONS FOR USE The Radical-7 Pulse Oximeter 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-7 Pulse Oximeter and accessories are indicated for use with adult, pediatric, infant 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 Radical-7 Pulse Oximeter 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-7 Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
1-3
1
overview Pulse
oximetry
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. 2. 3.
As a percent value for arterial oxygen saturation (SpO2) As a pulse rate (PR) As a plethysmographic waveform
The following figure shows the general monitoring setup. 1
1. Instrument 2. Patient Cable 2
3. Sensor 3
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).
2.
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-7 Pulse Oximeter uses a two-wavelength pulsatile system to distinguish between 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-7 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-7 for calculation.
1
overview
FUNCTIONAL VS. FRACTIONAL SATURATION The Radical-7 is calibrated to measure and display functional saturation: the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Radical-7 does not measure fractional saturation: oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin. To convert fractional saturation to functional saturation, the fractional saturation measurements must be converted according to: Functional saturation =
Fractional saturation 100 - (% carboxyhemoglobin + % methemoglobin)
x 100
MEASURED VS. CALCULATED SATURATION Oxygen saturation measurements obtained from a pulse oximeter are commonly compared to saturations calculated from the partial pressure of oxygen (PO2) obtained from an arterial blood gas sample. When comparing the two measurements, caution should be used when interpreting the values, as the calculated value obtained from the blood gas sample may differ from the SpO2 measurement of the pulse oximeter. Different results are usually obtained from the blood gas sample if the calculated saturation is not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. Also, as blood gas samples are usually taken over a period of 20 seconds (the time it takes to draw 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. 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-7 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology for calculation of the patient’s functional oxygen saturation and pulse rate. 1-4
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
1-5
1
overview
R/IR
R/IR
Digitized, Filtered & Normalized
Adaptive Filter with DSTTM
MEAS CONF Post Processor
■
The Radical-7 is a fully featured Handheld pulse oximeter
■
The Radical-7 is a fully featured standalone pulse oximeter
■
The Radical-7 interfaces to the SpO2 input module of multiparameter patient monitors* to upgrade conventional pulse oximetry technology to Masimo SET technology.
MEAS CONF
MEAS SSTTM
CONF
Confidence Based Arbitrator
90
Saturation
4
MEAS Proprietary Algorithm 4
2
The Handheld portion of the Radical-7 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-7 Handheld oximeter.
CONF
The Handheld oximeter snaps into the Radical-7 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-7 features nurse call, analog output and interfaces to serial printers.
MEAS Proprietary Algorithm 5
description
Introduction The Radical-7 provides the functionality of three pulse oximeters in one:
Masimo SET Parallel Engines
(Conventional Pulse Oximetry)
system
CONF
Masimo SET DST
Utilizing a SatShareTM cable, the standalone Radical-7 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-7 Docking Station, and SatShare cables are available to interface with most multiparameter patient monitors*. CAUTIONS: ■
THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE RADICAL-7 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-7 Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
2-1
2
system Radical-7
description
handheld
The Handheld Radical-7 provides most of the functionality of the pulse oximeter. All user input and displays are controlled by this part of the Radical-7 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. HANDHELD FRONT PANEL The following figure and corresponding text outline all the features of the Handheld Radical-7: Pleth + Signal IQ View 1
2
3
4
5
system
6
8
7
9
10
3
11
4
5 No Sensor
Masimo SET FastSat
100 85 %SpO2 140 50 BPM
23
HPO1
19 18
22 21 20
6
06:10:23pm 03/27/03
17
16 15 14 13
12
7
Numbers View 23
Masimo SET
100 85
%SpO2
160 40
11:42:46
5
8
TOUCH KEY CONTROL BUTTONS
11
SPEAKER
13
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
SENSITIVITY
10
12
2-2
Max APOD
BATTERY STATUS INDICATORS
22
2
Press down the Handheld Release Button and pull the Handheld device off the Docking Station.
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 SpO2 measurement. When a sensor is not connected to a patient MEASUREMENT and during pulse search, the display will show dashed lines. When the measured value is outside of the alarm limits, the DISPLAY SpO2 Measurement 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-7 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-7 display FastSat FASTSAT whenever the Radical-7 is set to operate in the FastSat mode. SATURATION The Saturation Alarm Limits Display shows the upper and ALARM LIMITS lower saturation alarm limits. When an alarm limit is reached or exceeded, the SpO2 value and the violated limit flashes. DISPLAY 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 ALARM STATUS indicate that the alarm is temporarily silenced. When the alarm is silenced through All Mute menu selection, which is INDICATOR 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. SYSTEM The system messages generated by the instrument are MESSAGE displayed in the System Message Area. See Section 5, System messages. AREA
9
BPM
03/27/03
HANDHELD RELEASE BUTTON
1
2
description
The Max or APOD sensitivity icon is shown on the Radical-7 display to indicate if the Radical-7 is set to operate in Normal sensitivity, Maximum sensitivity or Adaptive Probe Off Detection mode The Battery Status Indicators show the capacity of the Radical-7 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-7 by PATIENT CABLE plugging the cable into the Patient Cable Connector. Use only Masimo compatible sensors and cables with this oximeter. CONNECTOR See Section 8, Sensors and Patient Cables for more details. The Touch Key Icons indicate the software menu items that TOUCH KEY can be selected through the Touch Key Control Buttons. Pressing a Touch Key Control Button next to an icon selects ICONS the option.
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
2-3
The Pulse Waveform Display shows the acquired plethysmograph waveform. The pleth waveform is scaled with signal strength. Signal strength is defined as the relation of arterial pulsatile signal to the non-pulsatile signal component.
16
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.
17
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 available (again in addition to the no illumination level). Use the lowest illumination for most efficient battery usage. The 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.
BACKLIGHT/ CONTRAST BUTTON
ALARM SILENCE BUTTON
18
20
22
23
POWER/STAND BY BUTTON
The Output Mode Indicator displays the output mode selected by the user. The Output Mode Indicator also displays the type of SatShareTM cable. The Output Mode indicator is only displayed when the Radical-7 device actively outputs data other than ASCII text, or interfaces with a monitor through the SatShare cable. Press the Power/Standby Button to turn the instrument on. Press, hold the button for more than 2 seconds and then release the button to turn the instrument off.
PERFUSION INDEX
The Perfusion Index indicates numerically the percentage of pulsatile signal to non-pulsatile signal (pulse strength)
PULSE RATE ALARM LIMITS DISPLAY
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.
PULSE RATE
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.
OUTPUT MODE INDICATOR
19
21
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 further alarms are suspended until the pulse oximeter starts measuring SpO2 and pulse rate again. 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.
PI
Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
2
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.
1
2
1251 0000 536
15
PULSE WAVEFORM DISPLAY
system
11328/2269M-0805
SIGNAL IQ
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. The Signal IQ may also be shown as a single, pulsating bar.
14
2-4
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
2
3
1
DOCKING STATION CONNECTOR
The Radical-7 Handheld interfaces with the Docking Station through this connector.
2
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.
3
BATTERY PACK
The Radical-7 Handheld is powered by a NiMH battery located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries.
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system Radical-7
description
standalone
When the Radical-7 Handheld is placed into the Docking Station, the Radical-7 becomes a full-featured standalone device.The Radical-7 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. There are several models of Docking Stations available. The following table outline which features are available for each model of Docking Station. DOCKING STATION FEATURES
RDS-1 RDS-1B RDS-2 RDS-3 RDS-3B
RDS-4
system
description
2
STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical-7 Standalone device.
1
Masimo SET FastSat
Check Sensor
100 85 %SpO2
2 3
140 50 BPM
4
11:42:46
03/27/03
5
AC Power Input
■
■
■
■
SatShare Interface
■
■
Serial RS-232 Interface
■
■
■
■
Nurse Call/Analog Output Interface
■
■
■
■
Automatic Display Rotation Support (Gravity Detector)
■
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
■
1
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.
2
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.
3
VISUAL ALARM INDICATOR
The Visual Alarm Indicator is illuminated when an alarm condition is active and the Alarm Status Indicator is shown.
4
AC POWER INDICATOR
The AC Power Indicator is illuminated when the Radical-7 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.
■
■
10-hour Extended Battery
■
■
■
■
■
■
■ ■
■ ■
■ ■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
5
NOTE: When the Radical-7 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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system
description
STANDALONE BACK PANEL 1
system
description
2
SYMBOLS The following symbols are found on the back of the Radical-7 Docking Station and are defined below: 3
2
NOTE: Some of the interfaces and symbols are not available in all versions of the Docking Station. P1
P2
P3
RS-232
MEDICAL ELECTRICAL EQUIPMENT UL 60601-1/CAN/CSA C22.2 No. 601.1 80FK
Rx Only
SYMBOLS
Manufactured by: Masimo Corporation Irvine, CA 92618 USA Made in USA
SatShare interface
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®
Equipotential Ground Terminal 5
4
See Instructions for Use Fuse Replacement
1
2
3
4
5
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-7. 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-60601-1-1 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 Section 10 - Accessories of this manual or the Masimo web site at www.masimo.com for the latest SatShare cables and validated instruments.
POWER ENTRY MODULE
EQUIPOTENTIAL GROUND CONNECTOR
Analog Out Interface Nurse Call Interface WEEE Compliant Radical-7
monitor
interface
In addition to being a full-featured Handheld and Standalone Pulse Oximeter, the Radical-7’s unique SatShare interface links the Radical-7 to most existing multiparameter patient monitors through the pulse oximetry patient cable or SpO2 input 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.
Use the Equipotential Ground Connector for grounding.
■
Upgrades any approved and validated monitor to Masimo SET performance by using the calculated SpO2 and pulse rate determined by Radical-7 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. 2-8
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system
description
CAUTION: THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL. REFER TO THE RADICAL-7 DISPLAY FOR THE PATIENT WAVEFORM. CAUTION: ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
3
setup Introduction Before the Radical-7 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
for
monitoring
The following sections of the manual describe the preparation, set-up and initial installation of the Radical-7 Pulse Oximeter. RADICAL-7 POWER REQUIREMENTS Always use a hospital grade, AC power cable to connect the Radical-7 to an AC power source. Do not connect the Radical-7 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-7 Docking Station. The Radical-7 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-7 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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■
FOR HOSPITAL USE, CONNECT 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.
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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.
Monitor setup The Radical-7 maintains three types of default values which will automatically revert to after a power cycle:
■
TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS.
■ Custom – these settings can be changed by the user and retained through the power cycle.
■
DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR DIMMER.
■ 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-7 reverts to after a power cycle.
■ Factory – these options are restored to factory values
INITIAL BATTERY CHARGING Before use, the Radical-7 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 minimum, level 1
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-7 unit on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical-7 Standalone unit. Make sure that the Radical-7 loudspeaker is not covered to avoid a muffled alarm sound. The Radical-7 Handheld, Docking Station or Standalone should not be operated outside the following environmental conditions: OPERATING ENVIRONMENTAL CONDITIONS
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-7 will remember after a power cycle. OPTION
DEFAULT SETTING
DISPLAY VIEW AND CONTRAST
Set to pre-power down setting
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
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
OPERATING ALTITUDE
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
Configure the unit for your regional power line frequency (50 or 60 hz) if needed. Default is 60 hz (standard for the United States). See Section 4, Operation, Config.
CAUTION: THE UNIT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORESCENT LIGHTS AND OTHER SOURCES.
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setup
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setup
setup
OPTION
DEFAULT SETTING
CAUTION: SIMULTANEOUS USE OF SATHSARE AND SERIAL PORT IS NOT SUPPORTED.
PULSE BEEP VOLUME
Set to pre-power down setting
SATSHARE SETUP
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
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.
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.
3.
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.
4.
Verify that the Radical-7 recognizes the correct cable.The name of the SatShare cable will be displayed on the LCD screen when the SatShare mode is functional.
5.
Set the multiparameter monitor’s high and low saturation and pulse rate alarm limits as appropriate.
6.
Satshare setup The Radical-7 has been proven to be accurate during patient motion and low perfusion conditions. Saturation and pulse rate values from the Radical-7 may be displayed on a multiparameter monitor through the SatShare feature.
Set the multiparameter monitor's averaging time to the lowest setting (i.e. fastest response). The Radical-7’s ideal waveform necessitates 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.
7.
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.
While in the SatShare mode, if there are any significant discrepancies between the readings from the Radical-7 and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical-7 are to be considered the correct values.
8.
To use the Radical-7 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-7 is used in this mode, the length of time the Radical7 can operate on battery power will be significantly diminished.
9.
Set the SatShare Numbers and the Interface Alarms parameters in the General menu according to Customer preference.
3
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, Operation for details on enabling and setting these parameters.
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
ADULT / NEO SETTING (PRE DEFINED)
Set to pre-defined Adult or Neo setting
It is recommended that the Radical-7 is positioned close to the multiparameter monitor with the Radical-7 screen visibly displaying the plethysmographic waveform and the saturation and pulse rate measurements.
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setup
10. If displaying the simulated waveform is not desirable, it is recommended to turn off the pleth waveform display of the multiparameter patient monitor.
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.
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 THE RADICAL-7. WHEN THE AUDIBLE ALARM IS MUTED (INDICATED BY THE BELL WITH A SLASH THROUGH IT) ON THE RADICAL-7, 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-7 SCREEN. TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL-7 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.
■
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.
Philips
VueLink
setup
CAUTION: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED. ALSO, IF THE RADICAL DOCKING STATION IS COMPATIBLE WITH RADNETTM, VUELINK IS NOT SUPPORTED.
3-6
1.
Select the Philips VueLink selection from the Output menu on the Radical-7. Refer to Section 4, Output.
2.
Connect one end of the VueLink cable to the Serial Output connector on the back of the Docking Station.
3.
Connect the other end of the VueLink cable to the VueLink module and insert the module into the Philips monitor rack.
4.
The SpO2 and pulse rate values will automatically appear on the Philips monitor.
5.
In order for the pleth waveform to be displayed on the Philips monitor and for the Philips Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
3
setup
6.
The Radical-7 can be set up to audibly indicate all patient alarms while communicating with the Philips VueLink module. Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical-7.
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-7.
2.
Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the back of the Docking Station.
3.
Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal Flexport connector.
4.
The SpO2 and pulse rate values will automatically appear on the Spacelabs screen.
5.
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.
6.
The Radical-7 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-7.
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 RadNet selection from the Output menu on the Radical-7.
2.
Connect one end of the serial cable to the Serial Output connector on the back of the Docking Station.
3.
Connect the other end of the serial cable to the RadNet Interface Module connector.
4.
Turn the RadNet Interface Module on.
5.
The SpO2 and pulse rate values will automatically appear on the RadNet Central Station Monitor screen.
6.
In order for the pleth waveform to be displayed on the RadNet Central Station Monitor screen and for the RadNet Central Station Monitor to indicate the alarm conditions measured by the pulse oximeter, the user must configure the RadNet Central Station
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setup
monitor. Please see the RadNet Hardwired and Wireless Systems Operator’s Manual for complete instructions. 7.
The Radical-7 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-7.
operation
4
Introduction To operate the Radical-7 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.
CAUTION:REMOVING THE RADICAL-7 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, IT IS PREFERABLE TO UTILIZE THE HANDHELD LOCKING FEATURE.
■ 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.
2.
Connect the patient cable to the Patient cable connector of the Radical-7. Make sure it is a firm connection and the cable is not twisted, sliced or frayed.
3.
Ensure that the power cord is plugged into the Power Entry Module of the oximeter and into the AC power.
4.
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.
5.
Attach the sensor to the patient. Refer to the Directions for Use of the sensor.
6.
Connect the sensor to the unit (or patient cable) with the logos lining up; make sure it is a firm connection.
7.
Press the Power/Standby button to turn the oximeter on.
8.
Make sure the display window is free of alarm and system failure messages (see Section 5, Alarm Identification).
9.
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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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.
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.
■
“SENSOR OFF” appears in the message area of the graphic display.
■
The alarm tone sounds.
■ Do not select a site near potential electrical interference (electrosurgical unit, for example).
■
The alarm indicator flashes.
■ Read the sensor Directions for Use for proper sensor application.
■
Disconnect the sensor from the patient cable or oximeter.
■
Confirm that “NO SENSOR” appears in the message area of the graphic display.
12. Verify alarm silence operation. ■
Create an alarm condition by lowering the SpO2 or pulse rate high alarm limits beyond the patient readings.
■
Press the Alarm Silence button.
■
The alarm tone ceases for the displayed amount of time.
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.
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. MASIMO SENSORS Before use, carefully read the pertinent sensor Directions for Use. 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. CAUTIONS: ■
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 LNOP 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 USE ADDITIONAL TAPE TO SECURE SENSOR TO PATIENT.
17. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off.
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NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Radical-7 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 cause the pulse rate displayed on the pulse oximeter to be significantly different than the ECG heart rate. SIGNAL IQ The Radical-7 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-7 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-7 locates the arterial pulsation. The pulse tone (when enabled) coincides with the vertical line of the Signal IQ. As saturation increases or decreases, the pulse tone will ascend or descend accordingly, for each 1% change in saturation. 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-7 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-7 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
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Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
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continuously obtaining an arterial blood specimen for CO-Oximetry analysis may be considered to verify the oxygen saturation value. LOW PERFUSION The Radical-7 displays a “Low Perfusion” message when there are very low amplitude arterial pulsations. It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation1. This “localized hypoxemia” may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that correlates with the ECG heart rate.) CAUTION: IF THE LOW PERFUSION MESSAGE IS FREQUENTLY DISPLAYED, FIND A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS. 1
Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension and Vasoconstriction. Anesthesiology 1990; 73:532-537
ACTIONS TO BE TAKEN If the SpO2 readings show significant differences, do the following: ■ Make sure the emitter and photodetector are aligned directly opposite each other. ■ Select a site where the distance between the emitter and photodetector is minimized. ■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl salicylate and 2-10% menthol) for 20-30 seconds to increase perfusion. However, strong vasodilator creams, such as nitroglycerin paste, are not recommended. ■ If possible, remove electrical noise sources such as electrosurgical units or other electrical/electronic equipment. If these solutions are not possible, operate the oximeter on battery power, or try plugging the oximeter into a different electrical outlet. ■ If artificial nails or excessive fingernail polish are present, select another site or remove the polish/artificial nails. ■ If possible, ensure that the sensor is placed in a location with low ambient light. Although the Radical-7 with integrated Masimo Rainbow SET technology has significant immunity to ambient light, excessive ambient light may cause readings to be incorrect. CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE OXIMETER FOR PROPER FUNCTIONING. Radical-7 Signal Extraction Pulse Oximeter Operator’s Manual
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