Rad-8 Operators Manual Oct 2009

Rad-8

®

Pulse Oximeter

Signal Extraction Pulse Oximeter OPERATOR’S MANUAL

The Rad-8 Operating Instructions provide the necessary information for proper operation of the Rad-8 instrument. General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-8 are a prerequisite for its proper use. Do not operate the Rad-8 without completely reading and understanding the instructions in this manual. NOTICE: Purchase or possession of this instrument does not carry any express or implied license to use this instrument with replacement parts which would, alone or in combination with this instrument, fall within the scope of one of the patents relating to this instrument. CAUTION: Federal law (U.S.) restricts this instrument 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

80fk

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, 7,221,971, 7,215,986, 7,215,984, 7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 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.htm. Other patents pending. © 2009 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, SET, Radical, , Rad-8, Signal IQ, SIQ, FastSat, LNOP and LNCS are federally registered trademarks of Masimo Corporation. M-LNCS, M-LNC, LNOPv and APOD are trademarks of Masimo Corporation.

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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Rad-8 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. ■ Explosion hazard. Do not use the Rad-8 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. ■ High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not allow the Pulse Oximeter to obtain readings. ■ The Rad-8 is NOT intended for use as an apnea monitor. ■ The Pulse Oximeter should be considered an early warning instrument. As a trend towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition. ■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis. ■ The Rad-8 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 Rad-8 instrument. 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. ■ Do not place the Rad-8 or accessories in any position that might cause it to fall on the patient. Do not lift the Rad-8 by the power cord or any other cable. ■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ■ SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter can not measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. ■ For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present. NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (co-oximetry) of a blood sample should be performed. ■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements. When elevated levels of MetHb are suspected, laboratory analysis (co-oximetry) of a blood sample should be performed. ■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements. When elevated levels of COHb are suspected, laboratory analysis (co-oximetry) of a blood sample should be performed. ■ Elevated levels of Total Bilirubin may lead to inaccurate SpO2 measurements. ■ Severe anemia may cause erroneous SpO2 readings. ■ Do not use the Rad-8 or sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Rad-8 may affect the MRI image and the MRI instrument may affect the accuracy of the Pulse Oximetry parameters and measurements.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

■ If using Rad-8 during full body radiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read zero for the duration of the active irradiation period. ■ For home use, ensure that the Rad-8 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 Rad-8 before bathing the patient. ■ Additional information specific to Masimo sensors including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's Directions For Use (DFU). ■ Do not place the Rad-8 where the controls can be changed by the patient. ■ Do not place the Rad-8 face against a surface. This will cause the alarm to be muffled. ■ Do not place the Rad-8 on electrical equipment that may affect the Pulse Oximeter, preventing it from working properly. ■ Do not expose the Rad-8 to excessive moisture such as direct exposure to rain. Excessive moisture can cause the instrument to perform inaccurately or fail. ■ Do not place containers with liquids on or near the Rad-8. Liquids spilled on the instrument may cause it to perform inaccurately or fail. ■ If the Rad-8 fails any part of the setup procedures or leakage tests, remove the instrument from operation until qualified service personnel have corrected the situation. ■ If a sensor is damaged in any way, discontinue use immediately. ■ Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories. ■ The Rad-8 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: ■ Reorient or relocate the receiving instrument. ■ 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. Ensure the speaker is not covered or the instrument is not placed face-down on bedding or other sound absorbing surface. To protect against injury from electric shock, follow the directions below: ■ Avoid placing the instrument on surfaces with visible liquid spills. ■ Do not soak or immerse the instrument in liquids. ■ Always turn off and disconnect the power cord from the AC power supply before cleaning the instrument. ■ Use cleaning solutions sparingly.

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table of contents

SECTION 1 - OVERVIEW About This Manual... 1-1 Warnings, Cautions and Notes... 1-2 Product Description ... 1-3 Features... 1-3 Optional Features ... 1-3 Indications for Use ... 1-3 Pulse Oximetry ... 1-4 SpO2 General Description... 1-4 Principle of Operation ... 1-4 Functional Saturation... 1-5 Rad-8 vs. Drawn Whole Blood Measurements ... 1-5 Signal Extraction Technology (SET) for SpO2 Measurements ... 1-6 FastSat... 1-6 Masimo SET Parallel Engines ... 1-6 Masimo SET DST ® ... 1-7 SECTION 2 - SYSTEM DESCRIPTION Introduction ... 2-1 Rad-8 Front Panel (Horizonatal Model)... 2-2 Rad-8 - Front Panel (Vertical Model) ... 2-2 Rad-8 Front Panel Controls/Indicators ... 2-3 Rad-8 Rear Panel ... 2-4 Symbols ... 2-5 SECTION 3 - SETUP Introduction ... 3-1 Unpacking and Inspection ... 3-1 Preparation for Monitoring ... 3-1 Power Requirements ... 3-1 Initial Battery Charging ... 3-2 Initial Installation ... 3-2 SECTION 4 - OPERATION Introduction ... 4-1 Basic operation ... 4-1 General Setup and Use ... 4-1 Default Settings ... 4-2 Factory Default and User Configurable Settings ... 4-3 Successful Monitoring ... 4-4 Masimo Pulse Oximetry Sensors ... 4-4 Numeric Display - SpO2 ... 4-4 Numeric Display - Pulse Rate ... 4-5 Numeric Display - PI ... 4-5 Low Perfusion ... 4-5 Actions to be Taken ... 4-6 Signal IQ - (SIQ) ... 4-6 Sensor Placement ... 4-7 Sensitivity... 4-7 Low Battery Audible Alarm ... 4-8 Normal Patient Monitoring ... 4-9 Setup Menu ... 4-9 Menu Navigation ... 4-9 iv

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

table of contents

SECTION 4 - OPERATION (CONTINUED) Setup Menu Level 1 ... 4-9 Alarm Limits ... 4-9 LED Brightness... 4-10 Setup Menu Level 2 ... 4-10 Alarm Volume ... 4-10 Alarm Silence ... 4-11 Alarm Delay ... 4-11 Clear Trend ... 4-12 Button Volume... 4-12 Sensitivity... 4-13 FastSat... 4-13 Setup Menu Level 3 (Enter Button + Down Button Menu Settings) ... 4-14 Averaging Time ... 4-14 Rapid Desat Limit ... 4-15 Alarm On/Off... 4-15 Default Settings ... 4-16 SmartTone On/Off... 4-16 Year ... 4-17 Month ... 4-17 Day ... 4-18 Hour ... 4-18 Minute ... 4-19 Software Version ... 4-19 Serial Output ... 4-20 Interface Alarms ... 4-20 Nurse Call ... 4-21 Polarity ... 4-21 Setup Menu Level 4 (Enter Button + Up Button Menu Settings) ... 4-22 Set Mode ... 4-22 System Interfaces ... 4-22 Philips VueLink Setup ... 4-22 Patient Safety Net/RadNet Setup ... 4-22 Trend Setup and Use... 4-23 Introduction ... 4-23 Trend Utility Installation... 4-23 TrendCom Utility Operation... 4-23 Erasing Trend Memory... 4-23 Trend Data Format... 4-24 Sample Trend Output ... 4-24 Home Mode Operation... 4-25 Sleep Mode Operation ... 4-25 SECTION 5 - ALARMS AND MESSAGES Alarm Identification ... 5-1 Alarm Indication... 5-1 Alarm Limits... 5-2 Alarm Silence ... 5-3 Alarm Bell ... 5-3 Alarm On/Off ... 5-3 Messages ... 5-4 Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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table of contents

SECTION 6 - TROUBLESHOOTING Troubleshooting ... 6-1 SECTION 7 - SPECIFICATIONS Rad-8 Specifications ... 7-1 Performance ... 7-1 Accuracy ... 7-1 Electrical ... 7-1 Environmental ... 7-1 Physical Characteristics... 7-2 Serial Interface Specifications ... 7-3 Serial Interface Setup ... 7-3 Serial Printer Setup ... 7-4 Nurse Call... 7-4 Nurse Call Specifications ... 7-5 SECTION 8 - SENSORS & PATIENT CABLES Introduction ... 8-1 Selecting a Masimo SET Sensor... 8-1 Sensor Application Instructions ... 8-1 Masimo SpO2 Sensors... 8-2 Red Direct Connect Sensors ... 8-2 ® LNOP Reusable Sensors ... 8-3 LNOPv™ Adhesive Sensors ... 8-3 ® LNOP Specialty Sensors... 8-3 ® LNCS Reusable Sensors ... 8-4 ® LNCS Adhesive Sensors ... 8-4 ® M-LNCS™ DCI & DCIP Sensors ... 8-4 Sensor Accuracy ... 8-5 Cleaning And Reuse Of Masimo Reusable Sensors and Cables... 8-5 Reattachment of Single Use Adhesive Sensors ... 8-5 SECTION 9 - SERVICE AND MAINTENANCE Introduction ... 9-1 Cleaning ... 9-1 Battery Service ... 9-2 Performance Verification ... 9-2 Service and Repair... 9-4 Repair Policy... 9-4 Return Procedure ... 9-4 Sales & End-user License Agreement ... 9-5 Warranty ... 9-5 Exclusions ... 9-5 End-user License ... 9-6 Restrictions ... 9-7 SECTION 10 - ACCESSORIES Accessories ... 10-1

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

overview

1

About This Manual This manual explains how to set up and use the Rad-8 Pulse Oximeter. Important safety information relating to general use of the Rad-8 Pulse Oximeter 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 Rad-8 Pulse Oximeter system and its functions and features.

SECTION 3

SETUP describes how to setup the Rad-8 Pulse Oximeter for use.

SECTION 4

OPERATION describes the operation of the Rad-8 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 Rad-8 Pulse Oximeter.

SECTION 8

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

SECTION 9

SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Rad-8 Pulse Oximeter.

SECTION 10

ACCESSORIES list the available Rad-8 accessories.

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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 instrument 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.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

overview

1

Product Description The Rad-8 is a noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-8 features a multicolored LED display that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Perfusion Index (PI) and Signal Identification and Quality Indicator (Signal IQ ® ). The instrument consists of two models: the vertical Rad-8 and the horizontal Rad-8. FEATURES AND BENEFITS These features are common to the Rad-8: ■ Masimo SET is clinically proven to be the highest sensitivity and specificity pulse oximeter technology in the world. ■ Applicable for use on neonate, infant, pediatric and adult patients ■ Proven for accurate monitoring in motion and low perfusion environments ■ SpO2, pulse rate, alarm, and perfusion index displays ■ Signal I.Q. for signal identification and quality indication ■ FastSat® tracks rapid changes in arterial O2 saturation with high fidelity. ■ Variable pitch provides tonal variance for every 1% change in saturation. ■ Lightweight, convenient compact design ■ Audible and visual alarm for no sensor, sensor-off and low battery ■ One touch button access to alarms for High/Low saturation and High/Low pulse rate ■ User definable alarm limit settings ■ Sleep mode ■ Home mode ■ Stores up to 72 hours of trending memory ■ Adjustable alarm volume ■ Up to 7 hours Internal battery life with fully charged battery ■ Serial output port INDICATIONS FOR USE The Rad-8 Pulse Oximeter and accessories are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2). The Rad-8 Pulse Oximeter and accessories are indicated for use with adult, pediatric, infant and neonatal patients during both motion and no motion conditions, who are well or poorly perfused patients in hospitals, hospital-type facilities, mobile and home environments.

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1

overview Pulse Oximetry SpO2 GENERAL DESCRIPTION Pulse Oximetry is a continuous and noninvasive 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 following figure shows the general monitoring setup.

1. Instrument 2 Patient Cable

1 2

3. Sensor ®

3

PRINCIPLE OF OPERATION Pulse Oximetry is governed by the following principles: 1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) constituents differ in their absorption of visible and infrared light (using spectrophotometry, see figure below).

Absorption Spectra 8

Oxyhemoglobin

Absorption (mm-1)

Deoxyhemoglobin

6

4

2

0 600

650

700

750

800

850

900

950

1000

Wavelength (nm)

2. The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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overview

PRINCIPLE OF OPERATION (CONTINUED) The Rad-8 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 capillary bed (for example a fingertip, a hand or 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 Rad-8 utilizes a sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a photodiode (detector). The detector receives the light, converts it into an electronic signal and sends it to the Rad-8 for calculation.

1

1. Light Emitting Diodes (LEDs) 2. Detector

2

Once the instrument 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. The maximum of the skin surface temperature is measured at an ambient temperature of less than 106º F (41º C). This is verified by Masimo sensor skin temperature test procedures. FUNCTIONAL SATURATION The Rad-8 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. RAD-8 VS. DRAWN WHOLE BLOOD MEASUREMENTS When SpO2 measurements obtained from the Rad-8 (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratoryoximetry measurements may differ from the SpO2 measurements of the Rad-8 Pulse Oximeter. In the case of SpO2, 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 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 oxygen saturation of the patient is stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory oximetry measurements of SpO2 may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally, drawn, whole-blood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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1

overview

SIGNAL EXTRACTION TECHNOLOGY (SET) FOR SpO2 MEASUREMENTS 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 venous blood also moves, causing 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. FASTSAT FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Rad-8 is set to FastSat “On”, the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. With FastSat, the averaging time is dependent on the input signal. MASIMO SET PARALLEL ENGINES

LED Wavelengths

R/IR (Conventional Pulse Oximetry)

Intermediate Calculations

DST ® Adaptive Filter

Intermediate Calculations

Confidence

Confidence

Intermediate Calculations

Pre-Processing & Data Reduction Digitized, Filtered & Normalized

1-6

SST ™

Confidence

FST: Proprietary Algorithm 3

Intermediate Calculations

FST: Proprietary Algorithm 4

Intermediate Calculations

Pulse Rate Algorithm

Intermediate Calculations

Confidence Based Arbitrator

Post Processor

Confidence

Confidence

%SpO2 PI

Confidence

PR

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

overview

1

MASIMO SET DST

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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system description

2

Introduction The Rad-8 is designed for ease of operation. All pulse oximetry measurement information, as well as instrument status data, is displayed on the front panel of the instrument. All user input is handled by control buttons on the front panel and the sensor cable connection is located on the left side (when horizontal) and on bottom of instrument (when vertical). Primary features include: ■ Full Masimo SET technology in a small compact instrument ■ Supports the full line of Masimo sensors and patient cables (see Section 8, Sensors and Patient Cables) ■ Supports standardization of sensors and pulse oximetry technology throughout the hospital

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system description

RAD-8 FRONT PANEL (HORIZONTAL MODEL) 1

3

2

5

4

7

6

888 888

®

15

14

13

12

10

11

9

8

RAD-8 FRONT PANEL (VERTICAL MODEL)

7 6

8

5

4

888 888

9 10

11

3

12

2 13 1 14

15 ®

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

system description

2

Front Panel Controls/Indicators DESCRIPTION

CONTROL / INDICATOR 1

AC Power Indicator

The AC Power Indicator is illuminated when the instrument is connected to AC power.

2

Power On/Off

Press to turn the instrument on and off.

Up Button Down Button

Use these buttons to adjust the volume of the pulse beep tone. Within the menu/setup system, these buttons are used to select values within each menu option or the numeric value for the parameter/measurement alarm feature. Pressing and holding down these buttons allow for the rapid scrolling of alarm limits.

3

Used to enter the alarm limits menu in order to adjust Hi/Low SpO2, PI, and pulse rate alarm limits.

4

Alarm Limits Button

5

Signal IQ/Pulse Bar

6

Saturation Display

7

Alarm Silence Button

8

Alarm Bell

The alarm bell flashes to indicate an alarm condition.

9

Perfusion Index

The Perfusion Index provides an indication of the percentage of pulsatile signal to non pulsatile signal. The bar is highest when the quality of the perfused site is best.

10

Pulse Rate Display

The pulse rate in beats per minute (bpm). When searching for a saturation and pulse, “----” scrolls across the screen as the system calibrates and obtains patient data (approximately 10 seconds).

11

Enter Button

Used to enter the setup menus and to select/activate certain entries within the menu/setup system.

12

Brightness Button

Controls the level of the brightness for the LED display by providing 4 levels of brightness. Each press of the button increases the brightness one level. Once level 4 is accessed, an additional press of the button returns the brightness to level 1.

The LED indicator (located above the Alarm Limits Button) will illuminate when one or more of the factory default alarm settings is changed to alert the user to verify alarm settings. The Signal IQ provides an indication of the quality of the acquired signal as well as the timing of the pulse. A green vertical LED bar rises and falls with the pulse, where the height of the bar indicates the quality of the signal.

99

72

The functional arterial hemoglobin oxygen saturation is displayed in units of % for SpO2. When searching for a saturation and pulse, “----” scrolls across the screen as the system calibrates and obtains patient data (approximately 10 seconds). Press the Alarm Silence Button to temporarily silence patient and low battery alarms. Press the Alarm Silence Button when the “SEN OFF” message is flashing (i.e. the sensor is removed from the patient) to acknowledge the end of monitoring. In this state, all further alarms are silenced until the Pulse Oximeter starts measuring patient parameters/measurements again. NOTE: The alarm silence time can be set for 120, 30, 60 and 90 seconds. See Section 4, Setup Menu Level 2.

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system description

2

Front Panel Controls/Indicators continued DESCRIPTION

CONTROL / INDICATOR

Provides a visual representation of battery charge status. When unplugged, bars illuminate to indicate battery charge.

13

Battery Charge Level Indicator

14

Speaker

Provides audible indication of alarm conditions, pulse tone and feedback for key-presses.

15

Patient Cable Connector

Connects to a Masimo Pulse Oximeter sensor or Masimo Pulse Oximeter Patient Cable with a sensor.

A low battery status is indicated by a low audible beep and the first battery bar to the left flashing green.

RAD-8 REAR PANEL 1

4

2

3

2-4

1

NURSE CALL CONNECTOR

Use the 1/4” round Connector to interface with a nurse call system. This is a mono/stereo output and may be utilized with a mono or stereo cable. All external device connections to the Nurse Call Connector must be IEC-60950 compliant.

2

SERIAL OUTPUT CONNECTOR

Use the Serial Output Connector to connect a serial device, including a serial printer, to the Rad-8. See Section 7, Serial Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant.

3

POWER ENTRY MODULE

The power entry module contains the input connector for AC power. The AC input provides power to the system from the AC line. Always connect the pulse oximeter to the main power for continuous operation and/or battery recharging.

4

EQUIPOTENTIAL GROUND CONNECTOR

Use the Equipotential Ground Connector for grounding.

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system description

SYMBOLS The following symbols are found on the pulse oximeter or packaging and are defined below: SYMBOLS

DEFINITION RS-232 Equipotential Ground Terminal Caution, consult accompanying documents Nurse Call Interface WEEE compliant Defibrillation Proof (see front panel) Mark of Conformity to European Medical Device Directive 93/42/EEC

Rx Only

Federal law restricts this instrument to sale by or on the order of a physician (USA audiences only) Year of manufacture Underwriter's Laboratories Inc. certification Storage humidity range: 5% to 95%

5%-95% RH

+70 C

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

Storage temperature range: +70˚C to -40˚C Storage altitude range: +1600hPa to +500hPa Keep dry Fragile/breakable, handle with care Manufacturer

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