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Radical Signal Extraction Pulse Oximeter Operator’s Manual

i

The Radical Operating Instructions provide the necessary information for proper operation of all
models of the Radical pulse oximetry system. There may be information provided in this manual that
is not relevant for your system.

General knowledge of pulse oximetry and an understanding of the features and functions of the
Radical Pulse Oximeter are a prerequisite for its proper use.

Do not operate the Radical Pulse Oximeter without completely reading and understanding the
instructions in this manual.

NOTICE

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

CAUTION:

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

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

EU Authorized Representative for Masimo Corporation:

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

MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL 60601-1/CAN/CSA C22.2 No. 601.1

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419,  6,816,741,

6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311,

6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952,

5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international

equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare®

feature are also covered by U.S. Patent  6,770,028. Other patents pending.

© 2007 Masimo Corporation. Masimo, Radical, Discrete Saturation Transform, DST, Satshare,SET, LNOP, LNCS

and LNOPv are federally registered trademarks of Masimo Corporation.

RadNet, RadicalScreen, Signal IQ, FastSat, FastStart  and APOD are trademarks of Masimo Corporation.

EC REP

Содержание Radical Signal Extraction

Страница 1: ...signal extraction pulse oximeter O P E R A T O R S M A N U A L...

Страница 2: ...S i g n a l E x t r a c t i o n P u l s e O x i m e t e r O P E R A T O R S M A N U A L...

Страница 3: ...00 Fax 949 297 7001 www masimo com EU Authorized Representative for Masimo Corporation MDSS GmbH Schiffgraben 41 30175 Hannover Germany Tel 49 511 62 62 86 30 Fax 49 511 62 62 86 33 MEDICAL ELECTRICAL...

Страница 4: ...For home use ensure that the pulse oximeter s alarm can be heard from other rooms in the house especially when noisy appliances such as vacuum cleaners dishwashers clothes dryers televisions or radio...

Страница 5: ...EW About this Manual 1 1 Product description 1 3 Features and benefits 1 3 Indications for use 1 3 Pulse oximetry 1 4 General Description 1 4 Principle of Operation 1 4 Functional saturation 1 5 Measu...

Страница 6: ...o set up and use the Masimo SET Radical Pulse Oximeter herein known as the Radical Important safety information relating to general use of the Radical appears before this introduction Other important...

Страница 7: ...roughout the hospital SpO2 pulse rate alarm trending perfusion index Signal IQ and plethysmographic waveform display Automatic screen rotation provides upright display for vertical or horizontal monit...

Страница 8: ...te 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 P u l s e o x...

Страница 9: ...tor instantly upgrading the conventional pulse oximetry to Masimo SET pulse oximetry The SatShare cable attaches to the back of the Radical Docking Station and SatShare cables are available to interfa...

Страница 10: ...NSITIVITY The Max or APOD sensitivity icon is shown on the Radical display to indicate if the Radical is set to operate in Normal sensitivity Maximum sensitivity or Adaptive Probe Off Detection mode W...

Страница 11: ...erfaces with a monitor through the SatShare cable The Output Mode Indicator will take place of the Time and Date indicator when utilized Philips Vuelink 20 POWER STAND BY BUTTON Press the Power Standb...

Страница 12: ...dicator is illuminated when the Handheld unit is turned on and is properly interfaced to a Docking Station Check Sensor Masimo SET FastSat 11 42 46 03 27 03 100 85 SpO2 140 50 BPM 1 2 3 4 5 R a d i c...

Страница 13: ...nector for AC power and two fuses The AC input provides power to the system from the AC line Always connect the pulse oximeter to the mains power for continuous operation and or battery recharging NOT...

Страница 14: ...r cable to the power entry module of the Radical unit IEC 320 connector type at the Radical Connect the power cable to an AC power source Ensure that the unit is adequately powered by verifying that t...

Страница 15: ...4 Set to off SENSITIVITY Set to normal mode IFTHERE IS ANY DOUBT ABOUTTHE INTEGRITY OFTHE PROTECTIVE EARTH CONDUCTOR ARRANGEMENT OPERATE THE OXIMETER ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPP...

Страница 16: ...s and the Interface Alarms parameters in the General menu according to Customer preference 10 If displaying the simulated waveform is not desirable it is recommended to turn off the pleth waveform dis...

Страница 17: ...o indicate the alarm conditions measured by the pulse oximeter the user must configure the RadNet Central Station monitor Please see the RadNet Hardwired and Wireless Systems Operator s Manual for com...

Страница 18: ...Remove any substances that may interfere with the transmission of light between the sensor s light source and photodetector 5 Attach the sensor to the patient Refer to the Directions for Use of the se...

Страница 19: ...NECTORS ARE NOT WATERPROOF DO NOT STERILIZE BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE DO NOT ATTEMPT TO REPROCESS RECONDITION OR RECYCLE MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY...

Страница 20: ...gnal quality of the measurement With motion the plethysmographic waveform is often distorted and may be obscured by artifact The Signal IQ shown as a vertical line coincides with the peak of an arteri...

Страница 21: ...l displays a Low Perfusion message when there are very low amplitude arterial pulsations It has been suggested that at extremely low perfusion levels pulse oximeters can measure peripheral saturation...

Страница 22: ...n 90 degree increments T o u c h k e y c o n t r o l b u t t o n a n d i c o n s The touch key control buttons are the four dark grey control buttons to the right of the Handheld display To select a t...

Страница 23: ...ain menu is accessed the monitor remains functional and the saturation and pulse rate numbers will continue to be displayed MAIN MENU SELECTION The top menu category uses the following four menu selec...

Страница 24: ...ing NOTE The SpO2 low limit can not be set below the password protected minimum low SpO2 alarm limit See Section 4 Operation Display for details PULSE RATE HIGH LIMIT BPM The pulse rate high alarm lim...

Страница 25: ...Operator s Manual 4 MENU ITEMS DESCRIPTION VOLUME This menu allows the user to set the alarm volume Four levels are available level 1 being the softest and level 4 being the loudest The device retains...

Страница 26: ...ion battery Selecting Yes will disable Docking Station functions such as SatShare Serial and Analog output Selecting No will activate these Docking Station functions while operating on battery power W...

Страница 27: ...mally Open and Normally closed contacts See section 7 Analog output nurse call specifications O u t p u t Note The output menu selections are only available when the Radical Handheld is interfaced to...

Страница 28: ...NIMUM OF 87 HOURS 3 5 DAYS 10 SECONDS TYPICALLY 435 HOURS 18 DAYS S e r v i c e NOTE The Service menu selections are only available when the Radical Handheld is interfaced to the Docking Station Only...

Страница 29: ...play view is selected then pressing the Scroll Right button will scroll the displayed data by 1 hr to the right SCROLL LEFT Press the Scroll Left button to scroll through the data set The display scro...

Страница 30: ...adical to store one set of SpO2 PI and pulse rate measurements every 2 seconds resulting in a minimum trend capacity of 87 hours A setting of 10 for example sets the Radical to store one set of data p...

Страница 31: ...atShare mode Radical operates as follows All visual alarms remain active All audible alarms may be disabled by software configuration of the Radical The SpO2 and pulse rate numbers may or may not be d...

Страница 32: ...ate operator response is required Low priority alarms indicate that operator awareness is required ALARM DESCRIPTION HIGH PRIORITY Audible and visual alarms for low saturation SpO2 range 1 100 and pul...

Страница 33: ...n the saturation measurement or pulse rate measurement exceeds the low or high saturation or pulse rate alarm limits The Radical allows a user to delay audible saturation alarms by 0 5 or 10 seconds b...

Страница 34: ...of the fuses have blown Replace the fuses UNIT POWERS ON BUT THE GRAPHIC DISPLAY IS BLANK The viewing contrast is not correct Use the Backlight Contrast button to adjust the viewing angle If the condi...

Страница 35: ...w Perfusion3 Adults Pediatrics 2 digits Neonate 3 digits Pulse Rate Accuracy pulse rate 25 240 bpm No Motion1 Adults Pediatrics Neonate 3 digits Motion2 Adults Pediatrics Neonate 5 digits Low Perfusio...

Страница 36: ...n limit to 0 02 S e r i a l i n t e r f a c e s p e c i f i c a t i o n s The digital interface for serial communication is based on the standard RS 232 protocol The Radical by default always outputs...

Страница 37: ...2 SERIAL INTERFACE SETUP To interface with the Radical serial port set the following communication parameters on the interfacing serial device The pin outs for the RS 232 connector are shown in the f...

Страница 38: ...infrared heating lamps and direct sunlight can interfere with the performance of an SpO2 sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover the sens...

Страница 39: ...LNOP REUSABLE SENSORS LNOP sensors must be used in conjunction with PC cables Note The LNOP TF I and TC I sensors were not validated under motion conditions LNOP ADHESIVE SENSORS LNOP sensors must be...

Страница 40: ...from the patient 2 Disconnect the sensor from the monitor 3 Wipe the entire sensor clean with a 70 isopropyl alcohol pad 4 Allow the sensor to air dry before returning it to operation REATTACHMENT OF...

Страница 41: ...er use a soft cloth dampened with a mild soap and water Do not allow liquids to enter the interior of the instrument CAUTIONS DO NOT AUTOCLAVE PRESSURE STERILIZE OR GAS STERILIZE THIS OXIMETER DO NOT...

Страница 42: ...ld includes a 1 5 Amp Hour Nickel Metal Hydride battery The Radical Docking Station may include the optional 6 5 Amp Hour Nickel Metal Hydride battery Before using the Radical as a Handheld or transpo...

Страница 43: ...rs or during routine maintenance follow the procedure outlined in this section If the Radical fails any of the described tests discontinue its use and correct the problem before returning the unit bac...

Страница 44: ...as measuring data and verify that the resistance is less than 35 ohms SpO2 Pulse Rate High 100 140 Low 90 50 Power On Self Test 1 Connect the monitor to AC power and verify that the AC Power Indicator...

Страница 45: ...MAY ONLY PERFORM MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE REPAIR OF THIS EQUIPMENT Analog Output Test 1 Disconnect al...

Страница 46: ...f its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this agreement W a r r a n t y Masimo warrants t...

Страница 47: ...325 SATSHARE CABLE DS01 1539 SATSHARE CABLE DS02 1528 SATSHARE CABLE DS03 1357 SATSHARE CABLE HP03 1321 SATSHARE CABLE MQ01 1789 SATSHARE CABLE MS01 1367 SATSHARE CABLE NK01 1368 SATSHARE CABLE NK02 1...

Страница 48: ...on on both the sensors and monitors to ensure accurate pulse oximetry when needed most 2007 Masimo Corporation Masimo Radical Discrete Saturation Transform DST Satshare SET LNOP LNCS and LNOPv are fed...

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