Rad-8 Operators Manual Feb 2007

Operators Manual

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OPERATOR’S MANUAL

Signal Extraction Pulse Oximeters

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

RadNet, PI, APOD and LNOPv are trademarks of Masimo Corporation.

© 2007 Masimo Corporation. Masimo, Signal IQ, Discrete Saturation Transform, DST, Satshare, SET, , FastSat, Rad-8, Radlink, FastSat, SIQ, LNOP, LNCS and are federally registered trademarks of Masimo Corporation.

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, 6,501,975, 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. Other patents pending.

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 80FK

MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33

EC REP

EU Authorized Representative for Masimo Corporation:

For further information contact: Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com

CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

NOTICE Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.

Do not operate the Rad-8 pulse oximeter without completely reading and understanding the instructions in this manual.

General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-8 pulse oximeter are prerequisites for its proper use.

The Rad-8 Operating Instructions provide the necessary information for proper operation of all Rad8 pulse oximeter models.

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 unit. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.

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

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.

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 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.

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.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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

A functional tester cannot be utilized to assess the accuracy of the pulse oximeter or any sensors.

Consult the manufacturer for help.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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Reorient or relocate the receiving device. Increase the separation between the equipment.

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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:

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The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.

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

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Patient Safety - If a sensor or cable is damaged in any way, discontinue use immediately.

Failure of Operation - If the pulse oximeter fails any part of the setup procedures remove the pulse oximeter from operation until qualified service personnel have corrected the situation.

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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.

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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.

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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.

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

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The Rad-8 Compact 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.

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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

iii

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SECTION 4 - OPERATION Introduction... 4-1 Basic operation... 4-1 General Setup and Use... 4-1 Factory Default settings... 4-3 Successful SpO2 monitoring... 4-4 Numeric Display - SpO2... 4-4 Masimo Sensors... 4-4 Numeric Display - Pulse Rate... 4-5 Signal IQ and Pulse bar... 4-6 Low Perfusion... 4-7 Actions To Be Taken... 4-7 Low Battery Audible Alarm... 4-8 Normal patient monitoring... 4-8 Rad-8 front panel control operation... 4-8 Setup menu... 4-9 Menu Navigation... 4-9 Setup Menu Level 1 – Alarm features and sensitivity... 4-9 Setup Menu Level 2 – Button volume, LED brightness and factory default settings. 4-10 Setup Menu Level 3 - Clear trend... 4-10

SECTION 3 - SETUP Introduction... 3-1 Unpacking and inspection... 3-1 Preparation for monitoring... 3-1 Rad-8 power requirements... 3-1 Initial battery charging... 3-2 Initial installation... 3-2

SECTION 2 - SYSTEM DESCRIPTION Introduction... 2-1 Rad-8 front panel controls... 2-2 Rad-8 rear panel... 2-4 Symbols... 2-5

SECTION 1 - OVERVIEW About This Manual... 1-1 Warnings, cautions and notes... 1-2 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 Masimo SET Parallel Engines... 1-6 Masimo SET DST... 1-6

table of contents

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SECTION 8 - SENSORS & PATIENT CABLES Introduction... 8-1 Masimo SpO2 sensors... 8-1 Selecting a Masimo SET Sensor... 8-1 Sensor Application Instructions... 8-2 ® LNOP Direct Connect Reuseable Sensors... 8-2 ® LNOP Reusable Sensors... 8-2

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 specifications... 7-4 Nurse Call... 7-4

SECTION 6 - TROUBLESHOOTING Troubleshooting... 6-1

SECTION 5 - ALARMS AND MESSAGES Alarm identification... 5-1 Alarm indication... 5-1 Alarm limits... 5-2 Alarm Silence... 5-3 Alarm Silenced Indicator... 5-3 Messages... 5-4

Setup Menu Level 4 - Set date and time... 4-11 Setup Menu Level 5 - Output... 4-11 Output Description... 4-12 System interfaces... 4-13 Philips VueLink setup... 4-13 RadNet Setup... 4-13 RadLink Setup... 4-13 Special Menu... 4-14 Special Menu – Standard, Home and Sleep mode... 4-14 Home Mode operation... 4-14 Sleep mode Operation... 4-14 Trend setup and use... 4-15 Introduction... 4-15 TrendCom Utility Installation... 4-15 TrendCom Utility Operation... 4-15 Erasing Trend Memory... 4-16 Trend Data Format... 4-16 Sample Trend Output... 4-16

table of contents

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SECTION 10 - ACCESSORIES Rad-8 Units and Accessories... 10-1

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 Warranty... 9-5 Exclusions... 9-5 End-user license agreement... 9-5

LNOP Adhesive Sensors... 8-2 ® LNOP Specialty Sensors... 8-3 TM LNOPv Adhesive Sensors... 8-3 TM LNCS Reusable Sensors... 8-3 TM LNCS Adhesive Sensors... 8-3 Cleaning And Reuse Of Masimo Sensors... 8-4 Reattachment of Single Use Adhesive Sensors... 8-4 Masimo SET patient cables... 8-4 Cleaning And Reuse Of Masimo SET Patient Cables... 8-4

table of contents

SETUP describes how to setup the Rad-8 pulse oximeter for use. OPERATION describes the operation of the Rad-8 Pulse Oximetry system. ALARMS AND MESSAGES describes the alarm system messages. TROUBLESHOOTING describes troubleshooting information. SPECIFICATIONS gives the detailed specifications of the Rad-8 pulse oximeter. SENSORS AND PATIENT CABLES outlines how to use and care for the Masimo SET LNOP and LNCS sensors and Masimo SET patient cables. SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Rad-8 pulse oximeter. ACCESSORIES list the available Rad-8 accessories.

SECTION 3 SECTION 4 SECTION 5 SECTION 6 SECTION 7 SECTION 8

SECTION 9 SECTION 10

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SYSTEM DESCRIPTION describes the Rad-8 pulse oximeter system and its functions and features.

OVERVIEW gives a general description of pulse oximetry.

SECTION 2

SECTION 1

In addition to the safety section, this manual includes the following sections:

Read the entire safety information section before you operate the monitor.

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.

About This Manual

overview

Section 1 Overview

1-1

1-2

User defineable alarm limit settings Sleep study mode

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

NOTE: This is a sample of a Note.

Sample of Note:

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

INDICATIONS FOR USE The Rad-8 family of pulse oximeters 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 Rad-8 family of pulse oximeters 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.

RadNet and RadLink® capability.

Display capability on Philips/Agilent monitor through Philips VueLink function.

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8 hours Internal battery life with fully charged battery

Nurse call connection port

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Serial output port

Adjustable averaging 2 to 16 seconds

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Adjustable alarm volume

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Stores up to 72 hours of trending memory

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Three sensitivity levels - Max, Normal and APOD

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A NOTE is provided when extra general information is applicable.

Trauma mode FastSat mode

One touch button access to alarms for High/Low saturation and High/Low pulse rate

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Audible and visual alarm for no sensor, sensor-off and low battery

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Lightweight, convenient compact design

SpO2, pulse rate, alarm, and perfusion index displays Signal I.Q. for signal identification and quality indication

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Proven for accurate monitoring in motion and low perfusion environments

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CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.

Sample of Caution:

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.

Applicable for use on neonate, infant, pediatric and adult patients

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Clinically proven Masimo SET technology performance

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FEATURES AND BENEFITS These features are common to the Rad-8 family:

Sample of Warning:

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

The Rad-8 family consists of two models: the vertical Rad-8 and the horizontal Rad-8.

The Rad-8 family of pulse oximeters are noninvasive, arterial oxygen saturation and pulse rate monitors. The Rad-8 family 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 ® ).

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.

Product Description

overview

Warnings, cautions and notes

overview

1-3

1-4

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.

2. Recessed Photo Detector

1. Light Emitting Diodes (LEDs)

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Once the Rad-8 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.

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 (photodetector). The photodetector receives the light, converts it into an electronic signal and sends it to the Rad-8 for calculation.

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

3. Sensor

2. Patient Cable

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

1. Instrument

As a pulse rate (PR).

The following figure shows the general monitoring setup.

As a percent value for arterial oxygen saturation (SpO2) and

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 connects to the pulse oximetry instrument directly or 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 two ways:

overview

100 - (% carboxyhemoglobin + % methemoglobin)

Fractional saturation

x 100

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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 non-arterial 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.

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 and interpreting values, caution should be used, 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.

Functional saturation =

FUNCTIONAL VS. FRACTIONAL SATURATION The Rad-8 is calibrated to measure and display functional saturation which is the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Rad-8 does not measure fractional saturation which is oxygenated hemoglobin expressed as a percentage of all measured hemoglobin. This includes measured dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin. To convert fractional saturation to functional saturation, the fractional saturation measurements must be converted according to:

overview

1-5

1-6

MASIMO SET DST

Digitized, Filtered & Normalized

R/IR

CONF

MEAS

CONF

MEAS

CONF

MEAS Confidence Based Arbitrator

Saturation

Post Processor

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Proprietary Algorithm 5

Proprietary Algorithm 4

SST

MEAS

Adaptive Filter with DST® CONF

CONF

MEAS

(Conventional Pulse Oximetry)

R/IR

MASIMO SET PARALLEL ENGINES

overview

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Rad-8 family supports standardization of sensors and pulse oximetry technology throughout the hospital

Rad-8 family supports the full line of Masimo sensors and patient cables (see Section 8, Sensors and Patient Cables)

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Rad-8 family offers full Masimo SET technology in a small compact device

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The Rad-8 family of pulse oximeters are full featured pulse oximeters designed for ease of operation. All pulse oximetry measurement information, as well as device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel and the sensor cable connection is located on the left side of the Rad-8 horizontal and the bottom of the Rad-8 vertical.

Introduction

system description

2-1

2-2

Rad-8 Vertical

16 15

14 6

7 12

Used within the menu/setup system to move through setup options. Not active during normal patient monitoring Used to enter the setup menus and to select/activate certain entries within the menu/setup system. Used to enter the alarm menu to adjust Hi/Low SpO2 and heart rate alarm limits. Push once to temporarily silence the alarm for 120 seconds (default). Push a second time to return the unit to standard alarm monitoring after alarm condition has been corrected.

Next Button

Mode / Enter Button

Alarm Limits Button

Alarm Silence Button

Pulse Rate Display

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

The pulse rate in beats per minute (bpm). When searching for a saturation and pulse, it will flash dashed lines.

NOTE: The silence time can be set for 120, 90, 60 and 30 seconds. See Section 4 - Setup Menu Level 1..

NOTE: Pressing and holding down these buttons allow for the rapid scrolling of SpO2 and BPM alarm limits.

Within the menu/setup system, these buttons are used to select values within each menu option.

Up button Down button

Patient Cable Connector

Speaker

Connects to a Direct Connect Spot Check (DCSC) sensor or Masimo Patient Cable with a sensor. The icon next to the sensor indicates defibrillation proof.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Provides audible indication of alarm conditions, pulse tone and feedback for key-presses. Ensure the speaker is not covered or the unit is placed face-down on bedding or other sound absorbing surface.

The AC Power Charging indicator is illuminated when the Rad-8 is connected to AC line power and the battery is charging.

AC Power Charging Indicator 17

The yellow battery low indicator will illuminate with an audible alarm when the battery is low and requires recharging.

Battery Low Indicator 16

No sensor indicator will illuminate when no sensor is connected and an audible alarm will sound.

No Sensor Indicator

No Sensor

Sensor off indicator will illuminate when the sensor is off the patient and an audible alarm will sound.

Used to set the unit into the most sensitive mode and fastest averaging time.

Trauma Button Sensor Off Indicator

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.

Perfusion Index

Sensor Off

Sensitivity Mode Button/ Indicator

Used to set the unit in the FastSat Mode

Used to set the unit into Maximum Sensitivity, Normal Sensitivity, or APOD Mode.

Saturation Display

FastSat Button/ Indicator

The functional arterial hemoglobin oxygen saturation is displayed in units of SpO2. When searching for a saturation and pulse, it will flash dashed lines.

Signal IQ / Pulse Bar

DESCRIPTION

Rad-8 Horizontal

During saturation monitoring, use these buttons to adjust the volume of the pulse beep tone.

DESCRIPTION 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.

CONTROL / INDICATOR

system description

Used to turn the unit on and off.

Power On / Off

CONTROL / INDICATOR

Rad-8 front panel controls

system description

2-3

2-4

Distributed by: Masimo Corporation Irvine, CA 92618 USA

Use the Serial Output Connector to connect a serial device, including a serial printer, RadNet Interface Module, RadLink Interface Module or PC, to the Rad-8. See Section 7, Serial Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant. 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. Use the Equipotential Ground Connector for grounding.

SERIAL OUTPUT CONNECTOR

POWER ENTRY MODULE

EQUIPOTENTIAL GROUND CONNECTOR

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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

NURSE CALL CONNECTOR

Manufactured by: Masimo Corporation Irvine, CA 92618 USA

Made in USA

Rx Only

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

100-240v~50-60 Hz 15VA MAX

RS-232

Rad-8 rear panel

system description

+70 C

Fragile/breakable, handle with care

Keep dry

Storage temperature range: +70˚C to -40˚C Storage altitude range: +1600hPa to +500hPa

Storage humidity range: 5% to 95%

Underwriter's Laboratories Inc. approved

Year of manufacture

Federal law restricts this device to sale by or on the order of a physician (USA audiences only)

Mark of Conformity to European Medical Device Directive 93/42/EEC

Defibrillation Proof (see front panel)

WEEE compliant

Nurse Call Interface

Caution, consult accompanying documents

Equipotential Ground Terminal

RS-232

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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

-40 C

5%-95% RH

Rx Only

SYMBOLS

The following symbols are found on the back of the Rad-8 pulse oximeter or packaging and are defined below:

SYMBOLS

system description

2-5

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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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

CONNECT THE OXIMETER ONLY TO A HOSPITAL-GRADE RECEPTACLE (FOR HOSPITAL USE).

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CAUTION:

Connect a hospital grade power cable to the power entry module of the Rad-8 unit (IEC-320 connector type at the unit). 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 Rad-8 is illuminated.

The Rad-8 pulse oximeter is designed to operate on 100 to 240VAC, 50-60 Hz. The device is rated at 15 VA max.

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 Rad-8.

CAUTION: DO NOT CONNECT THE RAD-8 PULSE OXIMETER TO AN AC OUTLET CONTROLLED BY A SWITCH.

RAD-8 POWER REQUIREMENTS Always use a hospital grade, AC power cable to connect the Rad-8 pulse oximeter to an AC power source.

The following sections of the manual describe the preparation, set-up and initial installation of the Rad-8 pulse oximeter.

Preparation for monitoring

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.

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.

Unpacking and inspection

Before the Rad-8 pulse oximeter can be used in a clinical setting, it needs to be inspected and properly

Introduction

setup

3-1

3-2

Understand its status and alarm messages (see Section 5, Alarm Identification, System Messages and Section 6, Troubleshooting).

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5% to 95%, non-condensing 500 mbar to 1060 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m)

HUMIDITY

OPERATING ALTITUDE

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

+5°C to +40°C, +41°F to +104°F

TEMPERATURE

OPERATING ENVIRONMENTAL CONDITIONS

The Rad-8 should not be operated outside the following environmental conditions:

Pulse Rate Low Alarm Limit and Pulse Rate High Alarm Limit, Averaging Time.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

NOTE: “- - -” will flash on the numeric display until the SpO2 and pulse rate readings have stabilized (approximately 10 seconds).

10. On the display, verify the readings for SpO2 and pulse rate.

SpO2 Low Alarm Limit and SpO2 High Alarm Limit,

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Verify the display shows the following:

Mode setting: Standard (Std) or Sleep (SLP) or Home (Hnn)

Verify the front-panel display is free of alarm and system failure messages (see Section 5, Alarms and Messages).

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Verify all front-panel indicators momentarily illuminate and a tone is heard.

Press the Power button to turn the oximeter on.

6. 7.

With a single patient adhesive or disposable sensor, connect the sensor to the patient cable with the logos lining up; make sure it is a firm connection.

Refer to the Directions for Use of the sensor before attaching the sensor to the patient. If using a single patient adhesive or disposable sensor, check that the emitter (red light) and the photodetector are properly aligned.

If utilizing a patient cable, select a sensor that is compatible with the oximeter and the patient before connecting it to the patient cable. See Section 8, Sensors and Patient Cables. If using a reusable sensor, make sure it opens and closes smoothly. Remove any substances that may interfere with the transmission of light between the sensor’s light source and photodetector.

Connect a patient cable or a direct connect sensor to the Patient Cable Connector of the Rad-8 pulse oximeter. Make sure it is a firm connection and the cable is not twisted, sliced or frayed.

INITIAL INSTALLATION Place the Rad-8 on a stable hard flat surface near the patient. Always place the Rad-8 unit on a dry surface. Maintain a minimum of 1 inch (2.54 cm) free space around the unit. Make sure that Rad-8 loudspeaker is not covered to avoid a muffled alarm sound.

Inspect the oximeter case for damage.

Basic operation

Be familiar with its controls and operation.

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To charge the internal battery, plug in the AC power cord. Verify that the battery is charging. The green battery charging LED indicator on the unit will remain illuminated while the battery is charging.

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

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Know how the oximeter derives its readings (see Section 1, Pulse Oximetry)

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GENERAL SETUP AND USE

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

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To operate the Rad-8 pulse oximeter effectively, the operator must:

Introduction

operation

INITIAL BATTERY CHARGING Before use, the Rad-8 battery needs to be fully charged.

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.

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setup

4-1

4-2

The violated alarm limit and reading flash on the display.

The Visual Alarm Indicator flashes.

■

The alarm tone sounds.

The Visual Alarm Indicator flashes.

Disconnect the sensor from the patient cable or oximeter.

Confirm that the “no sensor” indicator illuminates.

■

Press the Alarm Silence button.

The alarm tone ceases for 120 seconds (default).

■

Set to level 5 Set to ASCII 2 Set to Alarm Set to Alarm Set to Normal

Audible Alarm off Alarm Delay Serial out Interface Alarm Nurse Call Type Nurse Call Polarity

17. Monitor the patient.

18. After monitoring is complete, remove the sensor from the patient and store or dispose of the sensor according to local laws. See the Directions for Use of the sensor.

19. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off [3 seconds in the Home Mode].

NOTE: Turn the oximeter off between patients so that it can re-calibrate in order to interpret new physiological data.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Set to Standard

Home Mode†

Normal/Invert

Alarm and Signal IQ/ Low Signal IQ/ Alarm

Alarm, Off/On

Philips/ASCII 1/ASCII 2

0, 5, or 10 seconds

On/Off or muted with reminder

Standard/Sleep/Home

Levels 1 thru 3

30, 60, 90, or 120 seconds

Off, Levels 1 thru 3

Levels 1 thru 4

NOTE: Defaults to APOD and Normal only. MAX sensitivity will default to Normal after a power cycle.

Max/Normal/APOD

Off/On

2, 4, 8, 10, 12, 14, or 16 seconds

25 to 235 BPM

30 to 240 BPM

1 to 100%

2 to 100%

CONFIGURABLE SETTING

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

* CAUTION: ALARMS ARE DISABLED IN THIS MODE. † If the unit is connected to a RadNet system, there will be no communication with RadNet in this mode.

Set to alarms active

Set to Standard

Set to 120 seconds Set to level 1

Alarm Silence Time

Set to level 2

Sleep Study Mode*†

Adjust the pulse beep volume.

■

Pulse tone volume

Display brightness

Alarm Volume

Adjust the alarm volume.

■

Set to Off

FastSat

Set to Norm setting

Set to Off

Trauma

Sensitivity

Set to 8 seconds

Set to 50 BPM

Pulse rate low alarm limit Averaging Time

Set to 140 BPM

Set to 90%

Set to Off

FACTORY DEFAULT SETTING

Pulse rate high alarm limit

SpO2 low alarm limit

SpO2 high alarm limit

OPTION

The following table outlines the default values that the Rad-8 reverts to after a power cycle if not changed by the user:

FACTORY DEFAULT SETTINGS The Rad-8 oximeters store two types of default values: those that the device automatically reverts to after a power cycle, and those that can be changed by the user which will be remembered after a power cycle.

operation

16. Verify the sensor is applied correctly and that the measured data is appropriate, see Section 4, Successful SpO2 Monitoring.

Adjust the alarm limits.

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14. To begin patient monitoring:

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

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13. Verify parameter-violation alarm silence operation.

NOTE: “No sensor” and “sensor off” will only generate an alarm if the Rad-8 was actively monitoring a patient when the sensor was disconnected.

“Sensor off” indicator illuminates.

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12. Verify the sensor alarms are functional by removing the sensor from the sensor site.

An alarm tone sounds.

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11. Verify that the patient alarms are functional by setting the high and low SpO2 and pulse rate alarm limits beyond the patient readings.

operation

4-3

4-4

Place the sensor on a site that has unrestricted blood flow.

Do not select a site near potential electrical interference (electrosurgical unit, for example).

Read the sensor Directions for Use for proper sensor application.

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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.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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 CONNEC TORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE (UNLESS OTHERWISE INDICATED ON THE SENSOR DIRECTIONS FOR USE). SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS.

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CAUTIONS

Tissue damage can be caused by incorrect application or use of an LNOP, LNOPv or LNCS 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.

Use only Masimo oximetry sensors for SpO2 measurements.

MASIMO SENSORS Before use, carefully read the LNOP, LNOPv and LNCS sensor Directions for Use.

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.

Place the sensor on a site that is not too thick, has sufficient perfusion and provides proper alignment of the LED’s and photodetector.

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The following general points will aid in ensuring oximetry monitoring success.

Successful SpO2 monitoring

operation

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Rad-8 may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable. The pulsations from intra-aortic balloon support can be additive to the pulse rate displayed on the pulse oximeter.

operation

4-5

4-6

Check the sensor and ensure proper sensor application. The sensor must be well secured to the site for the Rad-8 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, as may occur while lifting or crossing their legs, during a diaper change.

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Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

After performing the above, if the “Low Signal IQ” indication occurs frequently or continuously, obtaining an arterial blood specimen for CO-Oximetry analysis may be considered to verify the oxygen saturation value.

Assess the patient.

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The height of the Signal IQ bar 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. A “Low Signal IQ” is indicated by a bar height of two bars or less and the bars turn red. When this occurs, proceed with caution and do the following:

The Signal IQ is shown as a “bouncing bar” indicator, where the peak of the bar coincides with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Rad-8 locates the arterial pulsation. The pulse tone (when enabled) coincides with the peak of the Signal IQ bar. As saturation increases or decreases, the pulse tone will ascend or descend accordingly, for each 1% change in saturation.

SIGNAL IQ AND PULSE BAR The Rad-8 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 Rad-8 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.

operation

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

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.

If possible, ensure that the sensor is placed in a location with low ambient light. Although the Rad-8 pulse oximeter integrated with Masimo SET technology has significant immunity to ambient light, excessive ambient light may cause readings to be incorrect.

If possible, remove electrical noise sources such as electrosurgical units or other electrical/electronic equipment.

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Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (1030% methyl salicylate and 2-10% menthol) for 20-30 seconds. Strong vasodilator creams, such as nitroglycerin paste, are not recommended.

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If artificial nails or excessive fingernail polish are present, select another site or remove the polish/artificial nails.

Select a site where the distance between the emitter and photodetector is minimized.

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Make sure the emitter and photodetector are aligned directly opposite each other.

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ACTIONS TO BE TAKEN If the SpO2 readings show significant differences, do the following:

Vasoconstriction. Anesthesiology 1990; 73:532-537

1 Severinghaus JW, Spellman MJ. pulse oximeter Failure Thresholds in Hypotension and

CAUTION: IF THE LOW PERFUSION INDICATION IS FREQUENTLY DISPLAYED, FIND A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS.

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.)

LOW PERFUSION The Rad-8 indicates perfusion on a 10-bar LED indicator. The lower two segments of the bar will turn red when the amplitude of the arterial pulsations is very low (low perfusion).

operation

4-7

4-8

BUTTON

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

In the setup/menu system, the Up and Down Arrow keys select among the options for each setting and allows navigation through the menu(s).

During normal patient monitoring the Up and Down Arrow keys control the Pulse Tone volume. At the lowest setting, the pulse tone is muted. A lowpitch tone indicates the highest or lowest setting has been reached.

If a low battery alarm occurs during patient monitoring, pressing the Alarm Silence button will silence the audible alarm for 120 seconds (default).

Pressing this button will acknowledge and permanently silence a ‘sensor-off’ and ‘no-sensor’ audible alarm except in the Home and Sleep modes. In Sleep mode, all alarms are disabled. It will also permanently silence a low battery audible alarm if the Rad-8 is not monitoring a patient.

Alarm Silence. Pressing this button one time will silence the alarm for 120 seconds (default). A second press will return the unit to standard alarm monitoring.

Allows movement from one menu option to the next.

Enters the Rad-8 setup/menu system. See Section 4, Setup menu.

Power on/off. Press to turn Rad-8 on. Press-and-hold for 2 seconds to turn Rad-8 off.

FUNCTION

RAD-8 FRONT PANEL CONTROL OPERATION

The following sections describe the function of the Rad-8 front panel controls during normal patient monitoring.

During normal operation, the Rad-8 Display shows oxygen saturation (as % SpO2) and Pulse Rate (in beats per minute).

Normal patient monitoring

If a low battery condition occurs, immediately discontinue patient monitoring and plug the monitor into AC power.

If a low battery condition occurs while not monitoring a patient, pressing the Alarm Silence Button will suspend the audible alarm until the power is cycled or patient monitoring begins. A visual low battery indicator will continue to blink while audible alarms are silenced.

LOW BATTERY AUDIBLE ALARM If a low battery condition occurs during patient monitoring, a low priority alarm will sound, and can be silenced for 120 seconds (default) by pressing the Alarm Silence Button. Refer to Setup Menu Level 1 in this section to change setting.

operation

SETTING

Averaging. The signal averaging time of this device can be set to: 2†, 4†, 8, 10, 12, 14 or 16 seconds (Default 8 seconds)

Alarm Delay *0, 5, 10 seconds (Default 5 seconds)

Alarm on / off Alarm muted with reminder (Default on)

Alarm Silence Duration 30, 60, 90 and 120 seconds (Default 120 seconds)

Alarm Volume

NOTE: The parameter is set/ selected when Mode Enter or Next are pressed.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

†FastSat is automatically enabled in 2 and 4 second averaging.

occur. Alarm delay applies only when the saturation limit is exceed by less than 5%.

*Alarm delay allows the user to adjust the time in which the audible status indicator will

BUTTON

SETUP MENU LEVEL 1 – ALARM FEATURES AND SENSITIVITY. Push the Mode/Enter button to enter menu level 1.

NOTE: The Rad-8 will automatically ‘time out’ of the setup menu after 10 seconds with no key presses.

MENU NAVIGATION The Rad-8 set-up and configuration options are accessed through the menu system. The Mode/Enter key is used to enter the menu system and to move through the different menu levels. Within each level of the system, the Next key is used to move from one option to the next. The Up and Down arrow keys are used to select values within each option. The parameter is set/selected when either the Mode/Enter or Next keys are pressed.

This section gives an overview of the Rad-8 menu selections available. To navigate through the menus, use the Mode/Enter, Next, Up and Down keys located on the front panel of the oximeter. The following sub-sections describe each menu item in more detail. The oximeter has options that allow user configuration to suit specific needs.

Setup menu

operation

4-9

4-10

SETTING

NOTE: The parameter is set/selected when Mode Enter or Next are pressed.

Restore Factory Default Settings Yes / No

(First press Up arrow two times and then press Mode/Enter. Password: next button, up arrow, down arrow, next button)

Save User Identified Default Settings

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Button Volume (Off, 3 Levels)

NOTE: Active LED indicators are effected while adjusting this setting

LED Display Brightness (4 levels)

Clear Trend Yes / No

SETTING

NOTE: The parameter is set/selected when Mode Enter or Next are pressed.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

NOTE: It is recommended that you clear the trend prior to performing a new patient data collection procedure.

The Rad-8 only stores data in the trend memory while the device is turned on, and the trend data remains in memory until the memory fills up or cleared by the user.

BUTTONS

Push the Mode/Enter button again to enter menu level 3.

SETUP MENU LEVEL 3 - CLEAR TREND

NOTE: User default settings can be changed for specific patient environments.

BUTTONS

SETUP MENU LEVEL 2 – BUTTON VOLUME, LED BRIGHTNESS AND FACTORY DEFAULT SETTINGS Push the Mode/Enter button again to enter menu level 2.

operation

Set Minute

Set Hour

Set Day

Set Month

Set Year

Select Clock

SETTING

Alarm

Low Signal IQ

Alarm and Signal IQ

Nurse Call Polarity-Normal / Invert

Nurse Call Type

Alarm Monitor Interface On / Off

Serial out - Philips, ASCII 1, ASCII 2

Software Version

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

NOTE: See tables below for further description of features.

BUTTONS

NOTE: The parameter is set/selected when Mode Enter or Next are pressed.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

NOTE: The parameter is set/selected when Mode Enter or Next are pressed.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

SETUP MENU LEVEL 5 - OUTPUT Push the Mode/Enter button again to enter menu level 5.

BUTTONS

SETUP MENU LEVEL 4 - SET DATE AND TIME Push the Mode/Enter button again to enter menu level 4.

operation

4-11

4-12

DESCRIPTION

SERIAL

MENU ITEMS

The Rad-8 pulse oximeter can be set up to audibly indicate all patient alarms while communicating with the Philips/ VueLink module. Use the Interface Alarms setting in the Output menu to enable and disable audible alarms on the Rad-8.

Turn the RadNet Interface Module on. A proper connection is shown by the RadNet Interface Module's Online LED being solid. With a properly configured RadNet Interface Module, the Rad-8 will automatically display the SpO2 and Pulse Rate parameters on the screen at the RadNet Central Station.

4. 5.

Normal Standard polarity. See section 7, Analog output / nurse call specifications.

Invert This setting reverses the Normally Open and Normally closed contacts. See section 7, Analog output / nurse call specifications.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Pressing a sixth time returns the Rad-8 to patient monitoring in the Saturation/ Pulse Rate Mode. Additionally, the Rad-8 will automatically return to patient monitoring display from any menu level/setting after 10 seconds with no key presses.

Connect the other end of the serial cable to the RadLink Bedside Radio serial connector. Complete setup in accordance with the RadLink Operator's manual.

3. 4.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

Connect one end of the serial cable to the Serial Output connector on the back of the Rad-8.

RADLINK SETUP 1. Select the ASCII 1 selection from the Serial options on the Rad-8 pulse oximeter.

The Rad-8 pulse oximeter can be set up to audibly indicate all patient alarms while communicating with the RadNet Interface module.

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

Connect one end of the serial cable to the Serial Output connector on the back of the Rad-8.

RADNET SETUP 1. Select the ASCII 2 selection from the Serial options on the Rad-8 pulse oximeter.

The SpO2 and pulse rate values will automatically appear on the HP/Agilent monitor. In order for the pleth waveform to be displayed on the Philips/Agilent monitor and for the Philips/Agilent monitor to indicate the alarm conditions measured by the pulse oximeter, the user must configure the Philips/Agilent monitor. Please see the Philips/Agilent Operator’s manual for complete instructions.

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

Connect one end of the VueLink cable to the Serial Output connector on the back of the Rad-8.

PHILIPS VUELINK SETUP 1. Select the Philips VueLink selection from the Output menu on the Rad-8. After selecting, choose the preferred settings by stepping through menu options. Refer to Section 5, Output.

System interfaces

operation

Alarm & Low Signal IQ The nurse call output will be activated based on alarm and Low Signal IQ events.

Low Signal IQ The nurse call output will be activated based on Low Signal IQ events.

CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS THE RAD-8 PULSE OXIMETER IS CONNECTED TO THE AC MAIN POWER SUPPLY.

NURSE CALL POLARITY

NURSE CALL TYPE

The following serial output modes are supported. All serial output is RS232 based. See the interface specifications in Section 7, Specifications. ASCII 1 ASCII text data is sent to the serial interface at one-second intervals. The ASCII text includes: date and time stamp, SpO2 pulse rate, PI, and alarm and exception values. All text is single line followed by a line feed character and a carriage return. ASCII 2 ASCII text data is sent to the serial interface following a query from the connecting computer. RadNet data output is in this format. Philips VUELINK SpO2, pulse rate and plethysmographic waveform data are sent in Philips VueLink format to the serial port.

Alarms The nurse call output will be activated based on alarm events.

DESCRIPTION

MENU ITEMS

OUTPUT DESCRIPTION

operation

4-13

4-14

to toggle to

Sleep Mode* - (SLP)

Press

Home Mode - (Hnn)

Press

Enter Standard Mode - (Std)

SETTING

NOTE: Only available Indicators are illuminated while adjusting setting NOTE: The parameter is set/selected when Mode Enter or Next are pressed.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

CAUTION: ALARMS ARE DISABLED IN THIS MODE. NOTE: If the unit is connected to a RadNet system, there will be no communication with RadNet in Home and Sleep mode.

SLEEP MODE OPERATION The Rad-8 can be placed into the Sleep Mode to allow the unit to capture normal and abnormal patient data without triggering the alarms. This mode will blank out the unit display with the exception of the Battery Level Indicator and the Alarm Silenced Indicator and disable the alarms even after a power cycle. However, any single key press will bring the display back for 10 seconds. Upon power up, the SLP mode will be displayed along with a 10 second display of parameter settings. The Mode Enter and Next key held simultaneously for 3 seconds (select next (STD), Mode Enter) will put it back into the special menu to exit.

HOME MODE OPERATION The Rad-8 can be placed into the Home Mode to protect unqualified users from changing the Rad-8 alarm settings and operation. Only the following menu and front panel functions are available: display brightness (press + to adjust brightness), pulse beep volume adjustment and alarm suspend. Alarm volume is at highest setting. All default and user defined default settings are locked to their current values when home mode is selected and return to those values after a power cycle. Upon power up, the Hmm mode will be displayed along with a 10 second display of parameters. To turn the unit off the power key must be depressed and held for 3 seconds. The Mode Enter and Next key held simultaneously for 3 second will put it back into the special menu to select a different mode.

*CAUTION: ALARMS ARE DISABLED IN THIS MODE.

Simultaneous for 3 seconds

BUTTONS

This section gives an overview of the Rad-8 special menu selections available. To navigate through the menus, use the Mode/Enter, Next, Up and Down keys located on the front panel of the oximeter. The following sub-sections describe each menu item in more detail. The oximeter has options that allow user configuration to suit specific needs. SPECIAL MENU – STANDARD, HOME AND SLEEP MODE Turn instrument on, then push and hold the Mode/Enter and Next buttons simultaneously for 3 seconds to enter the special menu levels.

Special Menu

operation

Pulse Rate Low Alarm Limit

Pulse Rate High Alarm Limit

SpO2 Low Alarm Limit

SpO2 High Alarm Limit

SETTINGS

NOTE: The parameter is set/selected when the Mode Enter or Next are pressed.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

TRENDCOM UTILITY OPERATION 1. Turn Rad-8 off if not already off. 2. Connect serial cable to Rad-8 and other end to a com port on the PC. 3. Turn the Rad-8 on. 4. Start the TrendCom utility on the PC. 5. Select Rad-8 from the first pull-down menu. 6. Select the appropriate com port number from the second pull-down menu, if necessary. 7. Select the Output Delimeter Option (Tab, Comma or Space). 8. Select the RETRIEVE TREND button on the TrendCom utility. Select the desired location and assign a file name for the trend file. Select SAVE. 9. The Rad-8 will display “dat out” while trend data is being transferred. A progress bar will advance to indicate the status of the download. Larger trend files will take longer to download. Transfer time is approximately 20 seconds per hour of trend data. NOTE: During download of trend in formation, all normal Rad-8 functions are unavailable and the keypad is locked, except for the power button.

TRENDCOM UTILITY INSTALLATION Copy the TrendCom utility from the TrendCom CD onto a PC running MS-Windows.

A trend data download is initiated using the TrendCom utility which downloads the trend data and saves it to an ASCII text (.out) file with an output delimeter option.

Trend data is stored in non-volatile memory, so it is not erased when the unit is shut off.

A serial cable is required to connect the Rad-8 to a PC. Patient monitoring is not possible while trend memory is being transferred to a PC.

INTRODUCTION The Rad-8 can store up to 72 hours of SpO2, pulse rate, and perfusion index trend data captured at 2 second intervals. The trend data can then be transferred to a PC for evaluation.

Trend setup and use

BUTTONS

SPECIAL MENU – SpO2 AND BPM ALARM LIMITS

operation

4-15

4-16

When trend data transfer is complete, close TrendCom and disconnect the Rad-8 from the serial cable.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

07/21/04 09:56:08 SpO2=000 PR=000 PI=00.00 EXC=820:OffPat,SET 07/21/04 09:56:10 SpO2=000 PR=000 PI=00.00 EXC=828:Search,OffPat,SET 07/21/04 09:56:12 SpO2=097 PR=069 PI=04.69 EXC=800:SET 07/21/04 09:56:14 SpO2=096 PR=074 PI=02.28 EXC=C00:LowSigIQ,SET 07/21/04 09:56:16 SpO2=098 PR=078 PI=03.64 EXC=800:SET 07/21/04 09:56:18 SpO2=000 PR=000 PI=00.00 EXC=800:SET 07/21/04 09:56:20 SpO2=000 PR=000 PI=00.00 EXC=820:OffPat,SET 07/21/04 09:56:22 SpO2=096 PR=078 PI=02.68 EXC=800:SET

SAMPLE TREND OUTPUT

Exception Messages

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Audible alarm tone

An alarm condition is indicated by:

Audible and visual

ALARM TYPE

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

“no sensor” and “sensor off” will only generate an alarm condition after a pulse has been found.

Out-of-limit parameter will flash

00.00 to 20.00

Perfusion Index

Alarm indication

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001 to 240, or "---" meaning parameter not available

Pulse Rate

000 = Normal operation; no exceptions 001 = No Sensor 002 = Defective Sensor 004 = Low Perfusion 008 = Pulse Search 010 = Interference 020 = Sensor Off 040 = Ambient Light 080 = Unrecognized Sensor 100 = reserved 200 = reserved 400 = Low Signal IQ 800 = Masimo SET. This flag means the algorithm is running is full SET mode. It requires a SET sensor and needs to acquire some clean data for this flag to be set

001 to 100, or "---" meaning parameter not available

SpO2

Low battery High saturation (SpO2 range 2-100%)

Visual Alarm Indicator

HH:MM:SS

Time

Low

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MMDDYY

Date

Sensor off and no sensor

High pulse rate (pulse rate range 30-240 bpm) Low pulse rate (pulse rate range 25-235 bpm)

System failures

Low saturation (SpO2 range 1-100%)

PARAMETER

The exceptions are displayed as a 3 digit, ASCII encoded, hexadecimal value. The binary bits of the hexadecimal value are encoded as follows:

SPECIFICATION

High

TREND DATA FORMAT After a successful download of the trend data, a .out file will be created containing the trend-dump information in ASCII delimited format. The format is defined in the following table.

PARAMETER

ALARM PRIORITY

Two levels of alarm priority are implemented: high and low priority. The following table outlines the alarm priority specifications.

Audible alarms may be silenced, without affecting the operation of visual alarms.

The Rad-8 visually and audibly indicates alarm conditions that the system detects.

Alarm identification

alarms and messages

To erase (clear) the trend memory, see section 4, menu navigation, “clear trend” and follow the instructions. The Rad-8 continuously trends data. When performing a new study and gathering data on a new patient, it is highly recommended the "clear function" be utilized in order for the results to be separate. Turning the Rad-8 off will not erase the trend data.

ERASING TREND MEMORY

NOTE: Contact USB to serial port adapter manufacturer for assistance or support.

11. Turn the Rad-8 off to exit the trend download mode.

operation

5-1

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