Rad-57 Signal Extraction Pulse Co-Oximeter Service Manual April 2006

NOTE: (text in white, background black, pulse logo the same) Rad-57 

Signal Extraction Co-Oximeter

Service Manual

This Service Manual is intended to provide the necessary information for proper servicing of your unit. This manual is structured to support troubleshooting to the assembly or module level. This manual does not provide instructions for troubleshooting to the printed circuit board or component level. Do not service a Rad-57 unit without completely reading and understanding these instructions. Masimo service training is required prior to utilization of this manual. 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 Authorized Representative: MDSS GmbH Burckhardstrasse 1 D-30163 Hanover Germany Tel: +49-511-62 62 86 30 Fax:+49-511-62 62 86 33

Made in USA. © 2008 Masimo Corporation. All rights reserved. Masimo, Masimo Logo, SET, LNOP, LNCS, Radical, Rad-5, Rad-5v, Rad-57, Rad-8, Rad9, SIQ, FastSat, FastStart Signal IQ and APOD are trademarks of Masimo Corporation. Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 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. Other patents pending.

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

Table of Contents Page 1.

Overview ...3 1.1. About this Manual ...3 1.2. WARNINGS, Cautions and Notes ...3 2. Testing and Maintenance ...3 2.1. Introduction ...7 2.2. Cleaning...7 2.3. Battery Operation...8 2.4. Replacing the Batteries...8 2.5. Performance Verification ...9 3. Repair ...13 3.1. Safety Precautions:...13 3.2. General Procedures...13 3.3. Troubleshooting ...13 3.4. Service Messages: ...14 4. Repair and Returns ...16 4.1. Repair Policy...16 4.2. Return Procedure ...16 5. Drawings and Schematics...18

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

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1. Overview 1.1.

About this Manual

Important safety information relating to the general use of the Rad-57 appears in the Operator’s Manual. Other important safety information is located throughout this manual where appropriate. 1.2.

WARNINGS, Cautions and Notes

Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels is 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 a 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 device or damage to other property. Sample of a Caution: Caution: This is a sample of a Caution statement. A Note is provided when extra general information is applicable. Sample of a Note: Note: This is a sample of a Note statement. MODEL SUMMARY All models include SpO2 and pulse rate.

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

The Rad-57 product line has undergone significant enhancements (Rad-57 version 2). Included in these “New” enhancements; enabling the use of Rainbow adhesive sensors on all version-2 Rad-57 units as well as the addition of a numeric Perfusion Index display on the Rad57cm. Please see the attached pictures to determine which unit you have.

Previous Rad-57cm

New Rad-57cm

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

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New Rad-57c

Previous Rad-57c

New Rad-57m

Previous Rad-57m

__________________________________________________________

New Rad-57CM

Previous Rad-57cm

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

Previous

New

New

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

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2. Testing and Maintenance 2.1.

Introduction

2.1.1. This chapter covers; Cleaning, Battery Operation and Replacement, Testing and how to obtain service under normal operation. Note: No internal adjustments or recalibration are required.

2.1.2. Service should be done by qualified personnel only. Safety checks should be performed in accordance with local and governmental regulations. 2.2.

Cleaning

WARNING: BEFORE CLEANING THE CO-OXIMETER, TURN THE UNIT OFF. 2.2.1. To clean the display panel, use a cotton swab moistened with 70% isopropyl alcohol and gently wipe. 2.2.2. To clean the outer surface of the instrument, use a soft cloth moistened with a 70% isopropyl alcohol. WARNING: DO NOT ALLOW LIQUIDS TO ENTER THE INTERIOR OF THE INSTRUMENT. 2.2.3. To decontaminate unit, refer to Section 4.2.2. Cautions: •

Do not autoclave, pressure sterilize, or gas sterilize the oximeter.

•

Do not soak or immerse the monitor in any liquid.

•

Use the cleaning solution sparingly. Allow unit to air dry. Excessive solution can flow into the monitor and cause damage to internal components.

•

Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the panel.

•

Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the oximeter. These substances attack the device’s materials and device failure can result.

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

2.3.

Battery Operation

2.3.1. Included with the unit are (4) AA alkaline batteries. 2.3.2. Before using the unit as a handheld or transport monitor, it is best to verify the charge level of the batteries. Please reference the Operator’s Manual for specifications on battery capacity. 2.3.3. The battery charge LED indicators on the keypad will indicate the approximate life left with the batteries. 2.3.4. As a precaution against memory effects, it is advisable to replace the batteries as soon as the final indicator starts flashing. 2.4.

Replacing the Batteries

2.4.1. Turn the unit off and remove the patient cable connection. 2.4.2. Position the unit face down (use a soft surface to protect the unit from possible cosmetic damage). 2.4.3. Depress the ‘battery cover release button’ and slide the cover off. 2.4.4. Remove the (4) depleted batteries. Install the (4) replacement batteries into the battery compartment paying attention to proper polarity positioning. 2.4.5. Depress the battery cover release button and slide the cover back onto the unit. Verify the button pops up securing the cover. 2.4.6. As soon as the batteries are installed the unit will automatically turn on. Verify all LEDs illuminate momentarily, that all four battery charge LEDs remain lit, and that the unit stabilizes to its normal operation mode. Caution: Follow local governing guidelines for proper disposal of internal batteries. Do not incinerate.

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2.5. Performance Verification Caution: Rad-57 version 1 units the limits for SpCO and SpMet will remain set (“Sticky”) after a power cycle. SpO2 limits will revert back to pre-power down settings. Rad-57 version 2 units the SpO2 will remain sticky.

2.5.1.

If the co-oximeter fails any of the following tests, discontinue its use and correct the problem before returning the unit back to end user.

Note: Before testing, verify the batteries are fully charged. Disconnect any patient cables or sensors.

2.5.2. Power-On Self-Test 2.5.2.1. While the unit is off, depress the Power/Standby button and verify the unit turns on. Verify that all LED indicators illuminate momentarily and the speaker makes a beep sound. Depress and hold (~ 2 sec) the power button again and verify the unit turns off. 2.5.3. Key Press Button Test 2.5.3.1. With the unit on, press each soft key button (with the exception of the Power/Standby button), and verify that the oximeter acknowledges each key-press with an audible beep tone and/or by indicating an associated change on the display. 2.5.4. Menu Navigation Test 2.5.4.1.

With the unit turned on and no sensor plugged in, press the MODE-ENTER button several times slowly and verify the menu scrolls through the various top level menu selections:

2.5.4.1.1.

Monitoring level shows “No CbL”

2.5.4.1.2.

Level 1: Alarm volume “AL VOL”.

2.5.4.1.3.

Level 2: Alarm limits “90/LO”.

2.5.4.1.3.1.

2.5.4.1.4. 9

Sub Level 2: Hit the next button 4 to 7 times and verify alarm limit settings appear for SpCO and/or SpMet. Values will appear orange in color.

Level 3: Averaging and Sensitivity “SEN Nor”.

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

2.5.4.1.5.

Level 4: Trend settings “Tnd OFF”

2.5.4.1.6.

Level 5: Led brightness “888/888”.

2.5.4.1.7.

Press the button a sixth time. Menu should return to the beginning view “No CbL”.

2.5.5. Arrow Buttons – Parameter adjustments 2.5.5.1.

Press MODE-ENTER button twice (should be at the 90/LO selection). Verify the up and down arrows change the hi and low parameters.

2.5.6. Display Contrast Test 2.5.6.1.

With the unit turned on, depress the MODE-ENTER button (4) four times. When the display appears as 888/888, use the up and down arrows to verify the contrast both brightens and dims accordingly.

2.5.7. Testing with Masimo Set Tester (SpO2 only) 2.5.7.1.

(Currently, there is no Masimo Tester to simulate an SpCO or SpMet condition. However, it is possible to test the alarm capability of the unit by placing a sensor on a test subject. By setting the High limit of SpCO to 10% and Low limit to “Off” (factory default), it is generally understood that most healthy individuals will fall far below the High range and should not induce an alarm. Subsequently, setting the SpCO Low to a value of 5% will cause an alarm event.). See Reference chart below.

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2.5.8. %SpCO (Carboxyhemoglobin) Testing (If applicable) Note: This is performed as a functional test only. 2.5.8.1.

Connect a Masimo SET Rainbow sensor to the Rad-57 unit.

2.5.8.2.

Insert the non-dominant hand’s ring finger into the sensor.

2.5.8.3.

Under %SpCO, a healthy, non-smoking individual would have a typical reading between 0 – 5 on the display (see above chart). (These numbers are for reference only and should not be used for diagnostic purposes).

2.5.9. %SpMet (Methemoglobin) Testing (If applicable) Note: This is performed as a functional test only. 2.5.9.1.

Connect a Masimo SET Rainbow sensor to the Rad-57 unit.

2.5.9.2.

Insert the non-dominant hand’s ring finger into the sensor.

2.5.9.3.

Under %SpMet, a healthy, non-smoking individual would have a typical reading between 0 – 2 on the display. (These numbers are for reference only and should not be used for diagnostic purposes).

2.5.10. %SpO2 (Pulse-Oxygen Saturation) Testing 2.5.10.1. Connect the Masimo Set Tester to the Patient connecter. 2.5.10.2. Verify a reading appears within 10 seconds. The display should show numeric values of 82% +/- 2% for SpO2 and 61 +/- 1% for the BPM. 2.5.10.3. Test the alarm limits at each of the following settings: 2.5.10.4. Verify that at each alarm-inducing settings the unit initiates an audible alarm and a visual alarm (a red LED and the parameter number should be flashing). Verify the yellow “Alarm Silenced” LED is off during the alarm condition. Test 1 (Unit should not alarm) Limits High Low

% SpO2 90 75

Test 2 (Unit should alarm) Limits %SpO2 High 80 Low 75 11

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

Test 3 (Unit should not alarm) Limits BPM High 70 Low 55 Test 4 (Unit should alarm) Limits BPM High 60 Low 55 2.5.10.5. Press the Alarm Silence button once and verify the alarm is silenced and the yellow “Alarm Silenced” LED is flashing. 2.5.10.6. Wait 120 seconds and verify that the alarm silence times out and the audible alarm is activated again and the yellow LED turns off. 2.5.10.7. To disable Alarm mute, press the Alarm button once and verify an audible alarm is heard. 2.5.10.8. Press the up and down arrows while the unit is actively measuring vitals. Verify an increase and/or decrease in pulse volume. Continue pressing the down arrow to verify the pulse beep can be silenced. 2.5.11. Battery Test 2.5.11.1. Install four (4) “AA” alkaline batteries. Verify the unit turns on immediately after installation. 2.5.11.2. Turn the unit off, then on again. 2.5.11.3. If the unit was installed with brand new batteries, all four (4) battery charge LED indicators should be illuminated indicating a full charge. 2.5.11.4. If all four (4) LEDs are not lit, then remove all four (4) batteries and try another set. Repeat steps 4.7.2 and 4.7.3. 2.5.11.5. If all four (4) indicators are still not lit, contact Masimo Corporation using the information in Section 4.2.8 to request an RMA to return the unit for repair. 2.5.12. Trend download capability 2.5.12.1. Refer to Rad-57 Operator’s manual for download instructions (section 4 “Trend Setup and Use).

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3. Repair 3.1.

Safety Precautions:

WARNING: DO NOT DISASSEMBLE OR ASSEMBLE THE UNIT WHILE THE BATTERIES ARE STILL INSTALLED.

WARNING: ENSURE THE UNIT HAS BEEN PROPERLY CLEANED PER THE CLEANING INSTRUCTIONS.

3.2.

General Procedures

3.2.1. Examine the unit prior to disassembly or troubleshooting and inspect for cosmetic damage. External damage may be helpful in determining the root cause of the failure. 3.2.2. Note any markings or labeling the end user may have placed on the unit that may need to be duplicated or transferred in the event the housing or ancillary components are to be replaced. 3.2.3. Make note of the unit serial number. 3.2.4. Make note of the software versions in the event the Co-Oximeter board or system board is replaced, as these boards require software updates to make them compatible with the end user’s version of software. 3.2.5. Contact Masimo Corporation using the information in Section 4.2.8 to research the warranty history of the unit to determine if the unit will be covered under warranty. 3.3.

Troubleshooting

3.3.1. The troubleshooting procedures in this manual instructs the technician to isolate the failure down to the sub-assembly level. The intention is to have the Unit Under Test (UUT) repaired with minimal steps. The Masimo Set Tester is needed to perform the Performance Verification in Section 2.5 upon completion of repairs. 3.3.2. Tools required are as follows: Phillips head screwdriver #0 Multimeter 3.3.3. The troubleshooting steps below are presented in order of the most probable cause first. Proceed to the next step only if the unit continues to fail. 13

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

3.3.4. Always note the software versions prior to repair. 3.3.5. After unit has been repaired, the Perfomance Verification Section 2.5 must be performed. 3.4. Service Messages: Upon detection of a system error, the main software alerts the user with an audible alarm indicator and displays the appropriate error code on the Handheld’s main display. The MX board is held in reset and no other runtime functions are available to the user until the Handheld is put through a power cycle or until power is completely removed and re-applied to the system (removal and replacement of batteries).

System Error

System Error Code

MX Board Failure

1

MX Board Communication Failure

2

+5V Voltage Supply Out of Range

3

Red Voltage Supply Out of Range

4

Blue Voltage Supply Out of Range

5

Battery-Drop Voltage Out of Range

6

Battery Voltage Out of Range

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

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Symptom • Speaker Alarming (very loud) and unit is not functioning or displaying. • Alarm LED does not Illuminate 1. Unit is in an alarm state and an audible alarm can be heard. • Alarm Condition But No Audible Indication. 1. Unit is in an alarm state. • Alarm Silence LED not illuminated. 1. Unit is in a non-monitoring state. No alarm indicated. • Display Missing Segments • Button Function Error 1. Pressing one or more buttons will not activate the menu selection. • "No Sen" Message 1. A direct connect sensor or cable with sensor is attached. • "No CbL" Message (Rad-57) 1. Cable and/or sensor is connected. • Unit Will Not Turn Off

Cause and Corrective Action Steps • Probable Watchdog error. 1. Replace System Board.

1. Replace Keypad. 2. Replace System Board.

1. Replace Speaker. 2. Replace System Board. 1. Replace Keypad. 2. Replace System Board.

1. Replace Display. 2. Replace System Board. 1. Replace Keypad. 2. Replace System Board.

1. Replace sensor. 2. Replace patient cable. 3. Replace system board. 4. Replace co-oximeter board. 1. Replace cable (or direct sensor) 2. Replace system board. 1. Replace Keypad. 2. Replace System Board.

If unable to repair unit, then please call (800)326-4890 option #2 to arrange for return to Masimo Corporation.

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

4. Repair and Returns 4.1.

Repair Policy

4.1.1.

Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. The product must be repaired.

4.1.2.

Please clean contaminated/dirty equipment before returning. Make sure it is fully dry before packing the equipment.

4.1.3.

To return the Rad-57 unit for service, please follow the Return Procedure outlined in this section.

4.2.

Return Procedure

4.2.1.

Please clean contaminated/dirty equipment before returning and make sure it is completely dry before packing the equipment.

4.2.2.

Recommended decontamination procedure for the Rad-57: With potential exposure to blood or other potentially infectious materials.

4.2.2.1.

Put on a Lab coat and gloves or other protective garment.

4.2.2.2.

Place equipment on a designated decontamination table.

4.2.2.3.

Apply cleaning agent to paper towel. Clean with 70% Isopropyl alcohol wipes. Disinfect with a 1:10 ratio of bleach to water solution. Do not saturate. Wipe down all aspects of the equipment.

4.2.2.4.

Let the equipment air dry completely.

4.2.2.5.

Dispose of all contaminated products properly.

4.2.3.

Package the equipment securely – in the original shipping container if possible – and call or email Masimo Technical Support for the proper return authorization (RMA) form.

4.2.3.1.

4.2.4.

“Domestic” at (800)326-4890, option #2. “International” at (949)297-7498, option #2. “email” at [email protected] .

If more information is required beyond what is on the RMA, please attach a letter or email describing in detail any symptoms or difficulties experienced with the oximeter. Please include the RMA number in the letter.

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

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4.2.5.

Verify Warranty coverage with Masimo Technical Support.

4.2.5.1.

4.2.6.

If out of warranty; customer has the option to ship the unit to Masimo. Masimo will then prepare a repair estimate and contact customer for a purchase order authorization number to proceed with and cover the cost of repair.

Information required on the RMA form:

4.2.6.1.

Customer Ship-to information.

4.2.6.2.

Contact person(s): (name, telephone, fax number and/or email, department).

4.2.7.

Include a document stating the co-oximeter has been decontaminated for bloodborne pathogens.

4.2.8.

Return the co-oximeter to the following shipping address (which can also be found on the RMA form): Masimo Corporation 40 Parker Irvine, California USA 92618

13918/UM10030A-0406

(Domestic Toll Free): 800-326-4890, option #2 (International): 949-297-7498, option #2 (FAX): 949-297-7499

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Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406

5.

Drawings and Schematics

Rad-57 Signal Extraction Co-Oximeter Service Manual UM10030 – 0406