Service Manual
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Service Manual
Rad-67™ Pulse CO-Oximeter®
The Rad-67™ Pulse CO-Oximeter® Service Manual provides the necessary information for proper service of Rad-67. There may be information provided in this Service Manual that is not relevant for your system. 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. Masimo Corporation 52 Discovery 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 D-30175 Hannover, Germany
3149433
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH Conforms to ANSI/AAMI std. ES 60601-1:2005, Certified to CAN/CSA std. C22.2 No. 60601-1:2008, and applicable Particular, (ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-11:2010) Standards for which the product has been found to comply by Intertek.
Patents: www.masimo.com/patents.htm and Masimo are federally registered trademarks of Masimo Corporation. Rad-67™ is a trademark of Masimo Corporation. © 2020 Masimo Corporation
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Service Manual, Rad-67 This Service Manual provides information to perform basic service procedures on the following devices: •
Rad-67™ Pulse CO-Oximeter®
Refer to the Rad-67 Operator’s Manual for comprehensive list of safety information, warnings, and cautions.
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Contents Service Manual, Rad-67 ------------------------------------------------------------------------------------ 3 About This Manual-------------------------------------------------------------------------------------------7 Safety Information, Warnings and Cautions ----------------------------------------------------------- 9 Chapter 1: Maintenance Procedures-------------------------------------------------------------------- 11 Cleaning ------------------------------------------------------------------------------------------------- 11 Chapter 2: Software Procedures ------------------------------------------------------------------------- 13 Software Upgrade Procedure ------------------------------------------------------------------------- 13 Software Verification ---------------------------------------------------------------------------------- 14 Chapter 3: Service Procedures--------------------------------------------------------------------------- 15 Battery Operation and Maintenance --------------------------------------------------------------- 15 After Service Verification ----------------------------------------------------------------------------- 23 Chapter 4: Performance Verification Procedures ----------------------------------------------------- 25 Battery Test --------------------------------------------------------------------------------------------- 25 Power-On Self Test ------------------------------------------------------------------------------------- 27 Touchscreen Function Test --------------------------------------------------------------------------- 27 Spot Check Sessions/Trace ---------------------------------------------------------------------------28 Alarm Limit Test ---------------------------------------------------------------------------------------28 Chapter 5: Troubleshooting and Repair --------------------------------------------------------------- 29 Repair ---------------------------------------------------------------------------------------------------- 29 Troubleshooting ---------------------------------------------------------------------------------------- 31 Chapter 6: Warranty and Service Information -------------------------------------------------------- 37 Repair Policy -------------------------------------------------------------------------------------------- 37 Return Procedure--------------------------------------------------------------------------------------- 37 Contacting Masimo ------------------------------------------------------------------------------------ 37 Appendix: Rad-67 Component Diagrams -------------------------------------------------------------- 41 Rad-67---------------------------------------------------------------------------------------------------- 41 Index --------------------------------------------------------------------------------------------------------- 43
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About This Manual This Service Manual may contain technical information regarding troubleshooting, cleaning, electrical safety testing, functional verification and other pertinent service guidance. Keep this Service Manual in a convenient location for ready reference during service and maintenance. This Service Manual is intended for technical service, repair and biomedical personnel who maintain, troubleshoot and service this product as needed. Important safety information relating to general servicing of Rad-67 appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A Warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the user. WARNING: This is an example of a warning statement. A Caution is given when any special care is to be exercised by the or user to avoid injury, damage to this device, or damage to other property. CAUTION: This is an example of a caution statement. A Note is given when additional general information is applicable. Note: This is an example of a note. A Service Warning is given when service and maintenance actions may result in a serious outcome (for example, injury, serious adverse effect, and death) to the patient or user. The following is an example of a warning: Service Warning: This is a sample of a service warning statement. Authorized Service Personnel: Authorized Service Personnel is a user the manufacturer has deemed authorized to service products covered under the manufacturer’s warranty. Service conducted by anyone other than an authorized service personnel voids the warranty. The authorized service personnel are allowed to only perform tasks outlined in this service manual.
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Safety Information, Warnings and Cautions WARNING: This manual is intended for use by authorized service personnel only. WARNING: DO NOT service or make any modifications to Rad-67 other than those described in this manual. WARNING: Always ensure that the AC power has been disconnected from Rad-67 prior to opening up the device for service. WARNING: DO NOT use any device that appears to be damaged. Contact Masimo Technical Support in regards to any device that appears damaged. CAUTION: Prior to service, precautions must be taken to minimize potential damage to the device through electrostatic discharge (ESD): •
Use a conductive wrist strap attached to a good earth ground.
•
Always discharge yourself by touching a grounded bare metal surface or approved anti-static mat before working with the device.
•
Use an approved anti-static mat to cover your work surface.
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Chapter 1: Maintenance Procedures This chapter covers how to properly clean Rad-67. WARNING: Electrical shock and flammability hazard. Before cleaning Rad-67, always turn the unit off and disconnect the power cord from the back of the unit. CAUTION: Do not autoclave, pressure sterilize, or gas sterilize Rad-67. CAUTION: Do not soak or immerse Rad-67 in any liquid. CAUTION: Use the cleaning solution sparingly. Allow unit to air dry. Excessive solution can flow into Rad-67 and cause damage to internal components. CAUTION: 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. CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean Rad-67. These substances attack the device’s materials and device failure can result.
Cleaning The Rad-67 is a reusable device. The device is supplied and is intended to be used non-sterile. WARNING: To avoid electric shock, always turn off the Rad-67 and physically disconnect the AC power and all patient connections before cleaning. CAUTION: To avoid permanent damage to the Rad-67, do not use undiluted bleach (5% 5.25% sodium hypochlorite) or any other cleaning solution not recommended. To surface clean the Rad-67: •
Wipe the outer surfaces using a dampened soft cloth with one of the recommended cleaning solutions twice or until the surfaces are free of any visible residue.
Note: Pay particular attention to cracks, crevices, and hard to reach areas of the device. •
Repeat the above cleaning step using a fresh wipe.
•
Allow the Rad-67 to dry thoroughly before using again.
CAUTION: To avoid permanent damage to the Rad-67, do not use excessive amounts of liquids to clean the device. The surfaces of the Rad-67 may be cleaned with the following solvents or cleaning agents: •
≤ 70% Isopropyl Alcohol
•
Cidex Plus (3.4% glutaraldehyde)
•
10% (1:10) chlorine bleach to water solution
•
Quaternary ammonium chloride solution wipe
•
Oxivir® Tb Wipes
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Chapter 2: Software Procedures This chapter covers how to properly upgrade the software on Rad-67 and verify the upgrade is successful. These procedures should be performed by authorized service personnel only. Rad-67 software is updated using the Rad-67 Software Upgrade Tool (USB drive) and the Data Transfer Download Cable connected to the Masimo Proprietary Port on the bottom of Rad-67. The Software Upgrade USB Drive is available from Masimo for authorized service personnel by calling Masimo Technical Support. See Contacting Masimo on page 37. Data Transfer Download Cable
Software Upgrade Tool
Software Upgrade Procedure Ensure Rad-67 is fully charged before performing the software upgrade. 1. 2.
3. 4.
Completely turn off Rad-67 by holding down the Home Button for 8 seconds, until the device beeps. Connect the Data Download Cable to the Masimo Proprietary Port of the Rad-67 as shown.
Plug the upgrade USB drive into the USB end of the the Data Download Cable. Turn on Rad-67 by pressing the Home Button once, and the upgrading process will initiate automatically. This process lasts approximately two minutes, and a
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Rad-67 Service Manual
5. 6. 7.
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programming message is displayed on the screen during that time. Once programming is completed, Rad-67 will automatically power off and power back on, indicating that the software upgrade has successfully completed. Remove the Data Download Cable and the upgrade USB drive from Rad-67. From the main screen, access the Main Menu and navigate to the About screen. On the About screen in the Processor field, confirm that the new software has been updated.
Software Verification To verify the software version, perform the following: 1. 2. 3.
Turn on Rad-67 by pressing the Power Button once. From the Main Screen, access the Main Menu and navigate to the About screen. On the About screen in the Processor field, view the software version and confirm the software matches what has been installed.
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Chapter 3: Service Procedures This chapter covers how to recharge, test, and replace the battery, and how to perform electrical safety testing. No internal adjustment or recalibration is required. Service should be done by authorized service personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations.
Battery Operation and Maintenance The Rad-67 includes a lithium ion rechargeable battery. Before using the Rad-67 without the AC power connected, check the battery status indicator and ensure that the battery is fully charged. See Battery Charging on page 25. To charge the Rad-67 battery, refer to Battery Charging on page 25. Note: When battery run time is significantly reduced, it is advisable to completely discharge and fully recharge the battery.
Run Time for Rad-67 The following table outlines the estimated minimum run time of the battery in the Rad-67. •
The time estimates are based on a fully charged battery.
•
Time estimates are also based on specific operating modes.
For optimal battery run time, configure the device to automatically adjust the brightness. Configuration Operating Mode Rad-67
Minimum run time (Est.)
•
Not connected to AC power
•
All connectivity options turned off
•
Brightness level set to level 3
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Chapter 3: Service Procedures
Rad-67 Battery Replacement The following procedure provides instructions for removing the existing battery and installing a replacement battery in Rad-67 devices. Before replacing the battery, the battery must be determined to require replacement. See Battery Replacement Criteria below. Contact Global Services with questions regarding the Rad-67 battery replacement kit and/or the required tools part numbers. Contact information can be found at http://service.masimo.com.
Battery Replacement Criteria Before a battery is replaced, certain criteria must be met to determine if the battery is in actual need of replacement. Perform the following steps to determine the battery state of health: 1. 2. 3.
Access the Rad-67 Battery Diagnostic Screen. See Battery Diagnostics on page 26. Locate the Full Charge Capacity field on the Battery Diagnostic screen. The Full Charge Capacity should be greater than 3680MAH; otherwise, the battery may need to be replaced. Locate the Cycle Count field on the Battery Diagnostic screen. The battery may need to be replaced if the cycle count is over 500.
Supplied Parts List The following parts are supplied in the Rad-67 Battery Replacement Kit: 1 Battery
Required Tools The following tools are required when servicing the battery on Rad-67: •
ESD conductive wrist strap
•
ESD surface
•
Small, flat-tipped screwdriver
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Rad-67 Service Manual •
Chapter 3: Service Procedures
Needle-Nosed Pliers
Battery Removal CAUTION: Prior to service, precautions must be taken to minimize potential damage to the device through electrostatic discharge (ESD): •
Use a conductive wrist strap attached to a good earth ground.
•
Always discharge yourself by touching a grounded bare metal surface or approved anti-static mat before working with the device.
• 1.
Use an approved anti-static work surface. Turn off the device and unplug the power cord from the power entry module on the rear of the device (if connected). Begin by placing unit face down with bottom side facing up on an anti-static surface. Use the small flat screw driver to remove two (2) plastic pin assemblies from the bottom assembly of the Rad-67. Carefully insert the flat screwdriver into slight opening between the plastic pin and the device while pushing upward.
2. 3.
4.
Once the pin assembly unlocks and becomes loose, pull the remainder of the pin out by hand. Set the two (2) plastic pin assemblies aside for later use at reassembly.
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Rad-67 Service Manual
Chapter 3: Service Procedures
5.
Carefully remove the bottom assembly from the top assembly of the Rad-67. If needed use the flat screwdriver to assist in removing the bottom assembly from the top assembly of the Rad-67.
6.
Carefully detach the bottom assembly from the top assembly of Rad-67. Note: When removing the bottom assembly, the battery may remain attached to the bottom assembly with adhesive tape or the battery may remain inside the top assembly of Rad-67. The battery harness plugs into Rad-67. When removing the bottom assembly, be aware of the battery's location to prevent damage to Rad-67 when removing the bottom assembly. •
If the battery remains in the top assembly of Rad-67, remove the bottom assembly and set aside.
•
If the battery remains attached to the bottom assembly, carefully flip the bottom assembly over so both the top assembly and the bottom assembly are sitting face down side-by-side.
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Rad-67 Service Manual
Chapter 3: Service Procedures
7.
Disconnect the battery connector from Rad-67 (shown with battery in Rad-67).
8.
Remove the battery from Rad-67. •
If the battery remains in the top assembly of Rad-67, pull up on the battery to remove.
•
9.
If the battery is attached to the bottom assembly, carefully pull on the battery to release the adhesive attaching it to the bottom assembly. The flat-tipped screwdriver can be used to separate the battery from the bottom assembly if necessary. This completes the Rad-67 battery removal procedure.
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Rad-67 Service Manual
Chapter 3: Service Procedures
Battery Installation Note: The battery is installed into Rad-67 and not attached to the bottom assembly. 1. 2.
Prepare the new battery for installation by removing from the packaging. Attach the battery connector.
3.
After attaching the battery connector, place the battery face down into the Rad-67 opening, while avoiding any damage to the ribbon cables below the battery. Adhesive part of the battery should be facing up to be pressed against gray backing when the bottom assembly is reinstalled.
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Rad-67 Service Manual
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4.
Once the battery is in place inside Rad-67 be sure to firmly tuck away the battery harness wires to ensure the plastic pin assemblies can pass though the locks to attach the bottom assembly to the Rad-67.
5.
With the top assembly of Rad-67 laying face-down on the non-static work surface, place the bottom assembly on Rad-67. The white plastic tabs on the top assembly of the Rad-67 align with the bottom assembly openings.
6.
Firmly press down on the bottom assembly to seat the bottom assembly on the Rad-67 top assembly and align the locks to allow the plastic pin assemblies to be inserted. Insert the two (2) plastic pin assemblies until they are fully seated, to secure the bottom assembly to the Rad-67 top assembly.
7.
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Chapter 3: Service Procedures
Note: Some pressure may need to be applied to the bottom assembly to align the locks while inserting the pins. Both pins need to fully slide in. If any resistance is met when inserting the pins, remove the bottom assembly and confirm that the battery harness wires are not blocking the passage way for the plastic pins or that the seal is not misaligned, and not allowing the bottom assembly to fully seat.
8.
This completes the Rad-67 battery installation procedure. Verify proper operation of Rad-67. See After Service Verification on page 23.
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Rad-67 Service Manual
Chapter 3: Service Procedures
After Service Verification The following procedures are performed to verify proper operation of the device and check for electrical safety after service procedures are complete. DO NOT dock or connect any devices to Rad-67 before or during these procedures unless instructed to do so.
Battery Replacement Verification After battery replacement, verify the battery is identified by Rad-67. 1. 2.
Plug the Rad-67 AC Power Supply into the Masimo Proprietary Port on the bottom of the Rad-67. Verify the battery charge indicator on the home button of Rad-67 front panel illuminates if Rad-67 is off. •
3. 4.
If the battery charging indicator does not illuminate, this indicates the battery may not be properly connected. Press the power button and turn on the device. Verify the battery icon on the Main Screen indicates the battery is charging.
•
If the battery icon has a Red "X" through it, this indicates the battery may not be properly connected. Turn off the device and unplug the power cord, then remove the back panel and recheck the battery cable connection.
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Chapter 4: Performance Verification Procedures This chapter covers how to test the operation of Rad-67. No internal adjustment or recalibration is required. These procedures should be done by authorized service personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. To test the performance of Rad-67 following repairs or during routine maintenance, follow the procedure outlined in this section. If Rad-67 fails any of the described tests, discontinue its use and correct the problem before returning the unit back to the user.
Battery Test Battery Charging Rad-67 includes a Rechargeable Li-Ion battery Rated at 3.7V, 4600mAh. Before use, the Rad-67 battery must be charged completely. As a precaution against memory effects, it is advisable to completely discharge and fully recharge the batteries periodically. CAUTION: If the Rad-67 battery has not been charged for 1 month or more, then recharge the battery prior to use. CAUTION: At low battery warning, connect Rad-67 to AC power to prevent interruption of power. CAUTION: Additional information on the Rad-67 batteries may be found in the Operator's Manual for Rad-67. Note: When battery run time is significantly reduced, it is advisable to completely discharge and fully recharge the battery. To charge Rad-67 1. 2. 3.
Plug the Rad-67 AC Power Supply into the Masimo Proprietary Port on the bottom of the Rad-67. Make sure it is securely plugged in. Plug the Rad-67 AC Power Supply into an AC power source. Verify that the battery is charging: •
4.
When Rad-67 is ON and charging, the AC Power Indicator lightning bolt icon will appear on the screen.
• When Rad-67 is OFF and charging, the Home button will illuminate Orange. When the battery is fully charged: •
When Rad-67 is ON and fully charged, the AC Power Indicator will change to a plug icon.
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Rad-67 Service Manual
Chapter 4: Performance Verification Procedures
Touch the AC Power Indicator icon to view battery charge details. Refer to the Operator's Manual for Rad-67 for complete information.
Battery Diagnostics Battery diagnostics screen displays information about the current health of the battery. To view the Rad-67 Battery Diagnostics screen, perform the following: 1. 2. 3.
With Rad-67 On, press/select the battery icon at the top of the Rad-67 Main Screen. Next to Battery Diagnostics, select the View button. When prompted for a password, enter 5664 and the enter key. The Rad-67 Battery Diagnostics screen displays. Item*
Description
Battery Version
Battery software version loaded on device.
Temperature
Battery Temperature ( Kelvin 0.1K)
Voltage
Current battery voltage.
Flags
Battery charger status.
Remaining Capacity
Battery capacity remaining.
Full Charge Capacity
Capacity of the battery when fully charged.
Average Current Battery current draw. Positive value indicates charging current, negative value indicates discharge current. Time to Empty
Time in minutes until battery is depleted at current load.
Cycle Count
How many times the battery has been discharged completely and recharged.
State of Charge
Battery state of charge.
State of Health
Battery state of health.
* Items may differ based on installed software version.
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