signal extraction pulse oximeters OPERATOR’S MANUAL
The Rad-5 and Rad-5v Operating Instructions intend to provide the necessary information for proper operation of all Rad-5 and Rad-5v pulse oximeter models. There may be information provided in this manual that is not relevant for your pulse oximetry system. General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-5 and Rad-5v Pulse Oximeter are prerequisites for proper use.
ii SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES The Rad-5/5v Handheld Pulse Oximeter’s software program is designed to minimize the possibility of hazards from errors by following sound engineering design processes, Risk Analysis and Software Validation. ■ Do not place containers containing liquids on or near the pulse oximeter. Liquids spilled on the pulse oximeter may cause it to perform inaccurately or fail.
table of contents SECTION 1 - OVERVIEW About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 Warnings, cautions and notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 Features and Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . .
table of contents Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 Performance verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2 Service and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5 Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 overview Warnings, cautions and notes Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning: WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
1 overview INDICATIONS FOR USE The Rad-5 family of Handheld Pulse Oximeters and accessories are indicated for the continuous (Rad-5 only) or spotcheck, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
1 overview FUNCTIONAL VS. FRACTIONAL SATURATION The Rad-5/5v is calibrated to measure and display functional saturation: the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Rad-5/5v does not measure fractional saturation: oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin.
system description 2 Introduction The Rad-5 family of Handheld 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 at the top edge of the device. The Rad-5/5v are powered by 4 “AA” alkaline batteries, which provide over 48 hours of battery life.
2 system Rad-5/5v front description panel 1 controls 1 system description CONTROL / INDICATOR 2 DESCRIPTION 8 Power On / Off Used to turn the unit on and off. 10 9 Battery Level Indicator Four LED’s indicate the status of the battery. When the final indicator begins flashing, replace the batteries. 11 10 Visual Alarm Indicator Illuminates when any alarm condition exists. This indicator may not be turned-off or otherwise over-ridden.
2 system Rad-5/5v rear description panel 3 setup Introduction Before the Rad-5/5v Handheld Pulse Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be installed.
3 setup Monitor setup operation Introduction INITIAL SETUP 1. Inspect the oximeter case for damage. To operate the Rad-5 or Rad-5v Pulse Oximeters effectively, the operator must: ■ Know how the oximeter derives its readings (see Section 1, Pulse Oximetry) 2. Install 4 (four) new AA alkaline batteries. ■ Be familiar with its controls and operation. 3. Verify unit powers-up immediately after installing batteries. ■ 4. Turn unit off.
4 operation pulse rate alarm limits beyond the patient readings. ■ An alarm tone sounds. ■ The violated alarm limit and reading flash on the display. 11. Verify the sensor alarms are functional by removing the sensor from the sensor site. ■ “SEn OFF” message appears on the display. ■ The alarm tone sounds.
4 operation Successful SpO 2 operation 4 monitoring The following general points will aid in ensuring oximetry monitoring success. ■ Place the sensor on a site that is not too thick, has sufficient perfusion and provides proper alignment of the LED’s and photodetector. ■ Place the sensor on a site that has unrestricted blood flow. ■ Do not constrict the monitoring site when securing a sensor with tape.
4 operation SIGNAL IQ AND PULSEBAR The Rad-5/5v 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-5/5v 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.
4 operation BATTERY LEVEL INDICATOR Four LED indicators provide information on the remaining battery capacity. The operator should monitor these indicators periodically to determine remaining battery life and if the batteries should be replaced. Battery capacity is indicated in the following chart. 4 operation Normal patient monitoring During normal operation, the Rad-5/5v Display shows oxygen saturation (as % Sp02) on the upper number and Pulse Rate (in beats per minute) on the lower number.
4 operation RAD-5 FRONT PANEL CONTROL OPERATION BUTTON SETUP MENU LEVEL 1 – ALARM LIMITS AND ALARM VOLUME. FUNCTION SETTNG Power on/off. Press to turn Rad-5 on. Press-and-hold for 2 seconds to turn Rad-5 off. Alarm Volume Enters the Rad-5 setup/menu system. See Section 4, Setup menu. No function during normal patient monitoring. Pressing this button will acknowledge and permanently silence a ‘sensor-off’ and ‘no-sensor’ audible alarm.
4 operation SETUP MENU LEVEL 3 - TREND SETTINGS Push the Mode/Enter button again to enter menu level 3. SETUP MENU LEVEL 4 - LED BRIGHTNESS AND FACTORY DEFAULTS Push the Mode/Enter button again to enter menu level 4. To enable trending of patient data, the trend feature must be enabled (set to ON), and the current date and time must be set. See section 4, Trend setup and use. SETTNG The current date and time can only be set if the Trend is set to “ON”.
4 4 operation Trend Setup and Use (Rad-5 only) ERASING TREND MEMORY INTRODUCTION To erase (clear) the trend memory, turn the trend off and back on again. Enabling trend (setting Trend to “ON”) will erase all trend data. The Rad-5 can store 72 hours of SpO2 and Pulse Rate and Perfusion Index trend data, captured at 2 second intervals. This trend data can then be transferred to a PC for evaluation. Note: Turning trend off will not erase trend memory.
4 alarms Special menu Alarm messages An alarm condition is indicated by an audible alarm tone and visual alarm indicator. An Outof-limit parameter will flash on the Rad-5 only. “SEn OFF” and “nO SEn” will only generate an alarm condition after a pulse has been found. STANDARD 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 level.
5 alarms and messages The following table shows the potential result of failure to respond to the cause of the alarm condition: NEED OF PRIORITY RESPONSE Immediate High Prompt Delayed Low Prompt RESULT OF FAILURE Death or irreversable injury/ Reversable injury DESCRIPTION Having the potential for the event to develop within a period of time not usually sufficient for manual corrective action.
5 alarms and messages troubleshooting 6 Troubleshooting Message conditions for the Rad-5 follow: DISPLAY TYPE SOLUTION Return for service System Fault Defective sensor 5-4 There are several error codes, all error codes require return of the unit to an authorized service center for repair. See Section 9, Service and Repair. The following chart describes what to do if the Rad-5/5v system does not operate properly or fails.
7 specifications Rad-5/5v specifications PERFORMANCE measurement range SpO2: Pulse Rate: Perfusion: 1-100% 25-240 beats per minute (bpm) 0.
7 specifications 6.2” x 3.0” x 1.4” (15.8 cm x 7.6cm x 3.6 cm) 13oz. (0.32 kg) Rad-5 Modes Rad-5 Averaging mode: Rad-5 Sensitivity: Rad-5v Averaging mode: Rad-5v Sensitivity: 2, 4, 8,10, 12, 14 or 16 seconds6 Normal, Maximum and APOD 8 seconds Normal Alarms Sensor condition, system failure and low battery alarms Rad-5 only: Audible and visual alarms for high low saturation and pulse rate (SpO2 range 1-100%, pulse rate range 25-240 bpm) High Priority: 799 Hz tone, 5 pulse burst, pulse spacing: 0.
8 sensors & patient cables sensors & patient cables SENSOR APPLICATION SITE Unless indicated otherwise in the directions for use, reposition reusable sensors at least every 4 hours and adhesive sensors at least every 8 hours.
8 sensors & patient cables Masimo LNOPvTM ADHESIVE SENSORS (LNOPv sensors must be used in conjunction with PC cables) Weight sensors Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy Saturation Pulse Rate & SET patient patient cables 8 cables Reusable patient cables of various lengths are available. Only use appropriate Masimo oximetry patient cables for SpO2 measurements. Other patient cables may cause improper Rad-5/5v handheld pulse oximeter performance.
service / maintenance 9 Introduction This chapter covers how to test the operation of the Rad-5/5v how to properly clean the Rad-5/5v pulse oximeter, how to replace the batteries and how to obtain service. Under normal operation, no internal adjustment or recalibration is required. WARNING: BEFORE CLEANING THE OXIMETER, ALWAYS TURN IT OFF AND REMOVE THE BATTERIES. Cleaning To clean the display panel, use a cotton swab moistened with 70% isopropyl alcohol and gently wipe the panel.
9 service / maintenance by sliding it back up from the bottom of the device until the rectangular locking button snaps back into position. WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY AFFECT THE ACCURACY OF THE BATTERY LEVEL METER. service / maintenance 4. Repeat steps 1 to 3 with the Low Saturation Alarm parameter. 5. Repeat steps 1 to 3 with the High Pulse Rate Alarm parameter. 6. Repeat steps 1 to 3 with the Low Pulse Rate Alarm parameter. 7.
9 service / maintenance service / maintenance 4. Verify that the SpO2 measurement is between 79% and 84%. Service and 5. Verify that the pulse rate measurement is between 55 bpm and 65 bpm. 6. Press the Pulse Tone Volume button several times and verify that the loudness of the pulse beep tone increases, then is turned off, then repeats the cycle REPAIR POLICY Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment.
9 service / maintenance service Warranty Masimo warrants to the initial purchaser that each new pulse oximeter will be free from defects in workmanship or materials for a period of one (1) year from the date of purchase. Masimo’s sole obligation under this warranty is to repair or replace any product that Masimo deems to be covered under warranty with a repaired or a replacement pulse oximeter. Batteries are not warrantied.
10 accessories Rad-5 Accessories DESCRIPTION 1908 TrendCom Software for trend download. Requires MS-Windows, PRONTO trend download serial cable, TrendCom software and PC with available COM port. 1909 PRONTO trend download serial cable. Requires TrendCom software and PC with available COM port.
www.masimo.com Instruments and sensors containing Masimo SET technology are identified with the Masimo SET logo. Look for the Masimo SET designation on both the sensors and monitors to ensure accurate pulse oximetry when needed most. © 2007 Masimo Corporation. All rights reserved. Masimo, SET, , Radical, Rad-5, Rad-5v, PRONTO, TrendCom, SatShare, Signal IQ, SIQ, APOD, and FastSat are trademarks of Masimo Corporation.
