Addendum
34 Pages
Preview
Page 1
Radical-7 Service Addendum
The Radical-7 service addendum provides the necessary information for proper service of the Radical-7 Pulse CO-Oximeter. There may be information provided in this addendum that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of Radical-7 are prerequisites for its proper use. Do not service the Radical-7 without completely reviewing and understanding the instructions in the Operator’s Manual and this addendum. Service training provided by Masimo is required prior to utilization of this addendum. 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. Caution: Use of this device must follow the order of a physician. For professional use. See instructions for Use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. Wireless Radio FCC ID: VKF-RAD7CA or VKF-RAD7A, IC: 7362A-RAD7CA or 7362A-RAD7A 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 D-30175 Hannover, Germany 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
Patents: www.masimo.com/patents.htm © 2014 Masimo Corporation , Adaptive Probe Off Detection, APOD, 3D Alarm, Discrete Saturation Transform, DST, FastSat, FST, Masimo, Pulse CO-Oximeter, PVI, Radical-7, Root, rainbow, rainbow Resposable, RRa, SatShare, SedLine, SET, Signal Extraction Technology, Signal IQ, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation. 3D Desat Index Alarm, In Vivo Adjustment, ORI, rainbow Acoustic Monitoring, RAM, RDS, RRp, SpfO2 and SST are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademarks PATIENT SAFETYNET and PSN is under license from University HealthSystem Consortium.
www.masimo.com
1
Masimo
Contents About this addendum -------------------------------------------------------------------------------------- 5 Chapter 1: Service and Maintenance ---------------------------------------------------------------------7 Cleaning ---------------------------------------------------------------------------------------------------7 Battery Operation and Maintenance ---------------------------------------------------------------- 8 Electrical Safety Testing ------------------------------------------------------------------------------ 11 Functional Verification ------------------------------------------------------------------------------- 20 Repair Policy -------------------------------------------------------------------------------------------- 22 Return Procedure --------------------------------------------------------------------------------------- 22 Contacting Masimo ------------------------------------------------------------------------------------ 22 Appendix ---------------------------------------------------------------------------------------------------- 23 Radical-7 Functional Block Diagram ---------------------------------------------------------------- 23 Analog output/Nurse call test ----------------------------------------------------------------------- 24 System Faults ------------------------------------------------------------------------------------------- 25 Radical-7 Major Parts List ---------------------------------------------------------------------------- 26 Docking Station Major Parts List (RDS-1/RDS-3)------------------------------------------------- 27 Index --------------------------------------------------------------------------------------------------------- 29
www.masimo.com
3
Masimo
About this addendum This addendum explains how to service the Radical-7 Pulse CO-Oximeter. It contains technical information regarding troubleshooting, cleaning, electrical safety testing, functional verification and other pertinent service guidance. Keep this service addendum in a convenient location for ready reference during service and maintenance. This addendum is intended for technical service, repair and biomedical personnel who maintain, troubleshoot and service this product as needed. Refer to the Radical-7 Operator’s Manual for comprehensive list of safety information, warnings, and cautions. 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.
www.masimo.com
5
Masimo
Chapter 1: Service and Maintenance The following chapter contains information about cleaning, battery operation, safety testing, performance verification, service, repair, and warranty.
Cleaning Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. The Radical-7 is a reusable device. The device is supplied and used non-sterile. To surface clean the Radical-7 •
The outer surface of the device can be cleaned with a soft cloth dampened with a mild detergent and warm water solution.
•
Do not allow liquids to enter the interior of the device.
•
The outer surface of the device can also be wiped down using any of the following solvents: •
Cidex Plus (3.4% glutaraldehyde)
•
10% bleach solution
•
70% isopropyl alcohol solution
Using the recommended cleaning solutions on the touchscreen panel will not affect the performance of the Handheld.
www.masimo.com
7
Masimo
Radical-7
Chapter 1: Service and Maintenance
Battery Operation and Maintenance The Radical-7 Handheld includes a lithium ion rechargeable battery. The Radical-7 Docking Station may include the optional 6.5 amp-hour nickel metal hydride rechargeable battery. Before using the Radical-7 as a Handheld or as a transport monitor, the Handheld rechargeable battery and the optional Docking Station rechargeable battery must be fully charged. To charge the Handheld rechargeable battery and the Docking Station rechargeable battery 1. 2. 3.
Attach the Handheld to the Docking Station. Connect the Docking Station to AC power. Verify that the batteries are charging. •
The Docking Station Battery Charging indicator momentarily flashes and then remains illuminated while the batteries are actively charging.
•
If the internal battery temperature exceeds recommended operating conditions for proper battery charging, the Handheld Battery Charging indicator continuously flashes. When the temperature returns to recommended operating conditions, proper battery charging proceeds.
•
The Handheld battery requires approximately 4 hours for charging. The Docking Station battery requires approximately 6 hours for charging.
•
When both the Handheld Battery Charging indicator and the Docking Station Battery Charging indicator turn off, additional trickle charging may occur to complete charging.
During battery operation of the Radical-7, note that the following operating conditions affect the estimated run time of the included rechargeable batteries:
Estimated Run Times of Battery Power The following tables outline the estimated run times of the battery-powered Radical-7. The time estimates are based on a Radical-7 with fully charged batteries. The time estimates are also based on a Radical-7 with and without the back-light illuminated. The Radical-7 is always configured to include the Handheld battery. It may optionally be configured to include the Docking Station battery. Determine the configuration of the system before referencing the following tables.
www.masimo.com
8
Masimo
Radical-7
Chapter 1: Service and Maintenance
Run Time for Handheld Only In this configuration, the Radical-7 is configured to only include the Handheld battery (standard configuration). When running on battery power, it is advisable to operate only the Handheld. On battery power, it is possible to operate the Standalone (Handheld attached to the Docking Station with the Handheld battery providing power to the Docking Station). However, the capacity of the Handheld battery pack is not sufficient to support this mode for long periods of time. For optimal battery run time, configure the device to automatically adjust the brightness. Configuration
Operation Mode
Minimum run time
Handheld only Handheld, undocked, not connected to AC power 4 hours Handheld only Handheld docked, not connected to AC power
1 hour
Replacing the BatteriesBefore installing or removing the battery, make sure the AC power cord is removed and power to the Radical-7 is turned off. To replace the rechargeable Handheld battery 1. 2. 3. 4. 5.
Turn off the Radical-7 Handheld off and remove the patient cable connection. If docked, detach the Handheld from the Docking Station. Loosen the closure screw on the battery compartment door and lift out the battery. Take a new battery and place it in the compartment. Tighten the closure screw. Place the Handheld into Docking Station, turn on line power and charge battery.
See Battery Operation and Maintenance on page 8.
www.masimo.com
9
Masimo
Radical-7
Chapter 1: Service and Maintenance
Replacing the Fuses Should a power problem blow one or both of the fuses in the power entry module on the rear panel, the fuse(s) will need to be replaced (Fuses are part of Docking Station and not part of the Radical-7). Before starting, the user will need a 5-mm or 3/16-in screwdriver. To replace the fuse(s) 1. 2. 3. 4. 5. 6. 7.
8. 9.
Disconnect device from AC power. Remove AC power cord from the power entry module at the rear of the Docking Station. Using the screwdriver, gently pry loose the fuse cover in the left portion of the power entry module, exposing the fuse holder. Using the screwdriver, gently remove the fuse holder. Note how the fuse(s) are placed in the fuse holder for installation of the new fuse(s). To remove the fuses from the fuse holder, use the edge of the screwdriver blade to pry against the bottom of the metal portion of the fuse where it is secured to the glass portion of the fuse. Place the fuse(s) in the fuse holder, properly orienting the fuse(s). For fuse specifications, see Electrical in Radical-7 operator’s manual. Warning: Fire Hazard: To protect against fire hazard, replace only with fuses of same type, current rating, and voltage rating. Slide the fuse holder back into the power entry module and press firmly to make sure it is completely seated. Close the fuse cover and press gently until it seats completely, flush with the back of the Docking Station.
The device is ready to be reconnected to AC power. If the fuses blow shortly after replacement, the device requires service.
www.masimo.com
10
Masimo
Radical-7
Chapter 1: Service and Maintenance
Electrical Safety Testing General This section describes in general the electrical safety testing methodologies that can be performed on the instrument to detect potential electrical safety hazards. The testing referenced in this chapter is in accordance with IEC 60601-1, 3rd Edition standard.
Test Equipment Recommended 1. 2. 3. 4.
Electrical Safety Tester (NIST certified or equivalent) Digital Multimeter RDS-1/ RDS-3 Patient connector test body
Electrical Safety Tests The schematics presented in this section are based upon the IEC 60601-1, 3rd Edition standard. The schematics are provided to give a general idea of the test setup. The actual configuration of the test setup may vary based on the Electrical Safety Tester being used. Service Warning: Before starting the testing, it is important to place the device under test (DUT) on an insulating surface. Service Warning: Refer to general safety considerations, warnings and cautions of the Electrical Safety Tester used before testing the DUT. Service Warning: Follow the setup instructions provided as part for the Electrical Safety Tester’s operating instructions before starting testing. Service Warning: Make sure that the Electrical Safety Tester and DMM are under calibration before starting the testing.
www.masimo.com
11
Masimo
Radical-7
Chapter 1: Service and Maintenance
Verification of Electrical Outlet and Power Cable 1. 2. 3. 4. 5.
Check ratings (Maximum Current, Maximum Voltage, and Maximum Power) of power outlet and confirm safety test can be performed on that particular outlet. Check power outlet wiring is good and according to local electrical code standards. Always use power supply cord supplied by Masimo Corporation Check power supply cord for kinks or any kind of damages or anomalies and always check continuity of line, neutral and earth conductors if in doubt and replace the power supply cord as necessary. Accuracy of electrical safety testing performed is dependent on all the factors mentioned above in this section.
Device Classification per IEC-60601-1 Product Name
Configuration
Power Source
Classification
Type of Patient Protection
Handheld
Battery Powered
Internally Powered
Type BF Applied Part
Standalone (Docked to RDS-1, RDS-3)
AC Powered Class I
Radical-7 Type BF Applied Part
The electrical safety tests mentioned below are applicable based on Classification and Type of Patient Protection.
www.masimo.com
12
Masimo
Radical-7
Chapter 1: Service and Maintenance
Ground Continuity Test (Class I devices only) Ground continuity should be detected from the accessible earth of the device to the earth pin of the mains plug of the connected Masimo power supply cord or directly to the Earth pin of the appliance inlet of the DUT. Refer to schematic below for this test setup:
The following steps should be followed to conduct the ground continuity test: 1. 2. 3. 4.
Connect Masimo power supply cord to appliance inlet on the DUT. Connect Digital Multimeter (DMM) between the accessible earthed metal part and the earth pin of the Masimo power supply cord. Check for continuity using the continuity test feature of the DMM. Move the connected Masimo power cord around and confirm that there is no intermittent continuity.
www.masimo.com
13
Masimo
Radical-7
Chapter 1: Service and Maintenance
Measuring Earth Leakage Current (Class I devices only) Earth leakage current is the current that flows from the Mains Part through or across the insulation into the protective earth conductor. The earth leakage current is measured in both “Normal” condition (NC) and as well as “Single Fault Condition” (SFC). Refer to the schematic below for the general test setup:
For more specific test setup, follow the setup instructions as part of your Electrical Safety Tester.
www.masimo.com
14
Masimo
Radical-7
Chapter 1: Service and Maintenance
The following test conditions should be considered for Earth Leakage Current testing: Measuring
Measuring
Point A
Point B
Protective Earth
DUT Earth
Protective Earth
Protective Earth
Protective Earth
Protective Earth
Protective Earth
1
DUT Earth
DUT Earth
DUT Earth
DUT Earth
DUT Earth
Input Voltage
Frequency
Device
Polarity
Neutral
State
120 Vac or
50 or 60
240 Vac
Hz
120 Vac or
50 or 60
240 Vac
Hz
120 Vac or
50 or 60
240 Vac
Hz
120 Vac or
50 or 60
240 Vac
Hz
120 Vac or
50 or 60
240 Vac
Hz
120 Vac or
50 or 60
240 Vac
Hz
Test Condition
Leakage Current 1 Limit
ON
Normal
Closed
NC
5 mA
ON
Reverse
Closed
NC
5 mA
OFF
Normal
Closed
NC
5 mA
OFF
Reverse
Closed
NC
5 mA
OFF
Normal
Open
SFC
10 mA
OFF
Reverse
Open
SFC
10 mA
Earth Leakage Current limits based upon IEC 60601-1, 3rd Edition
* MD (Measuring Device) and its frequency characteristics should be based upon IEC 60601-1, 3rd Edition, Clause 8.7.4.4.
www.masimo.com
15
Masimo
Radical-7
Chapter 1: Service and Maintenance
Measuring Touch Leakage Current Enclosure or touch leakage current is the leakage current flowing from exposed surfaces on the DUT, excluding patient connections, through an external path other than the protective earth conductor to earth or another part of the enclosure. Refer to schematic below for this test setup:
For more specific test setup, follow the setup instructions as part of your Electrical Safety Tester.
www.masimo.com
16
Masimo
Radical-7
Chapter 1: Service and Maintenance
The following test conditions should be considered for Touch Leakage Current testing: Measuring
Measuring Point B
Point A
Input
Frequency
Voltage
Polarity
Neutral
Earth
State
Protective
DUT’s exposed
120 Vac or
50 or 60
Earth
conductive Chassis
240 Vac
Hz
Protective
DUT’s exposed
120 Vac or
50 or 60
Earth
conductive Chassis
240 Vac
Hz
Protective
DUT’s exposed
120 Vac or
50 or 60
Earth
conductive Chassis
240 Vac
Hz
Protective
DUT’s exposed
120 Vac or
50 or 60
Earth
conductive Chassis
240 Vac
Hz
Protective
DUT’s exposed
120 Vac or
50 or 60
Earth
conductive Chassis
240 Vac
Hz
Protective
DUT’s exposed
120 Vac or
50 or 60
Earth
conductive Chassis
240 Vac
Hz
2
Device
Test
Leakage
Condition
Current 2 Limit
ON
Normal
Closed
Closed
NC
100 μA
ON
Reverse
Closed
Closed
NC
100 μA
OFF
Normal
Open
Closed
SFC
500 μA
OFF
Reverse
Open
Closed
SFC
500 μA
ON
Normal
Closed
Open
SFC
500 μA
ON
Reverse
Closed
Open
SFC
500 μA
Touch Leakage Current limits based upon IEC 60601-1, 3rd Edition
www.masimo.com
17
Masimo
Radical-7
Chapter 1: Service and Maintenance
Measuring Patient Leakage Current (Radical-7 docked to RDS-1/RDS-3 only) Patient leakage current is the leakage current that flows from the individual patient connector (Lead/probe) of the DUT via the patient to earth. Refer to schematic below for this test setup:
For more specific test setup, follow the setup instructions as part of your Electrical Safety Tester.
www.masimo.com
18
Masimo
Radical-7
Chapter 1: Service and Maintenance
The following test conditions should be considered for Patient Leakage Current testing: Measuring
Measuring Point
Input
Point A
B
Voltage
Protective
DUT’s patient
120 Vac or
50 or 60
Earth
connector
240 Vac
Hz
Protective
DUT’s patient
120 Vac or
50 or 60
Earth
connector
240 Vac
Hz
Protective
DUT’s patient
120 Vac or
50 or 60
Earth
connector
240 Vac
Hz
Protective
DUT’s patient
120 Vac or
50 or 60
Earth
connector
240 Vac
Hz
Protective
DUT’s patient
120 Vac or
50 or 60
Earth
connector
240 Vac
Hz
Protective
DUT’s patient
120 Vac or
50 or 60
Earth
connector
240 Vac
Hz
3
Frequency
Device
Polarity
Neutral
Earth
State
Test
Leakage
Condition
Current Limit
ON
Normal
Closed
Closed
NC
100 μA
ON
Reverse
Closed
Closed
NC
100 μA
OFF
Normal
Open
Closed
SFC
500 μA
OFF
Reverse
Open
Closed
SFC
500 μA
ON
Normal
Closed
Open
SFC
500 μA
ON
Reverse
Closed
Open
SFC
500 μA
3
Patient Leakage Current limits based upon IEC 60601-1, 3rd Edition
www.masimo.com
19
Masimo
Radical-7
Chapter 1: Service and Maintenance
Functional Verification Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. To test the functionality of the Radical-7 following repairs or during routine maintenance, follow the procedure outlined in this chapter. If the Radical-7 fails any of the described tests, discontinue its use and correct the problem before returning the device back to the user. Before performing the following tests, do the following: •
Place the Handheld into the Docking Station.
•
Connect the Docking Station to AC power and fully charge the Handheld battery.
•
Disconnect any patient cables or pulse oximetry probes.
•
Disconnect any SatShare, serial or analog output cables from the device.
•
Set the Radical-7 to Normal operating mode by going to the Main menu and the Home Use feature to No.
Power-On Self Test To conduct a Power-On Self Test 1. 2.
Connect the Battery Module to the Device Module. Refer to Setup for instructions on how to connect the Battery Module to the Device Module. Upon connection, the device emits a tone and the Masimo logo displays.
Alarm Limit Test To conduct an Alarm Limit Test 1. 2. 3. 4. 5.
Change the High SpO2 Alarm parameter to a value two points below the currently selected value. See Alarms for SpO2 in Radical-7 Operator’s manual. Verify that the newly set parameter is shown on the Display screen. Return the parameter to its original setting. Repeat steps 1 to 3 for all active parameters. Reset the alarm limits again to the original settings.
Testing with the optional Masimo SET Tester To conduct a test with the optional Masimo SET® Tester 1. 2. 3.
Turn off and then turn on the Radical-7. Use the Patient Cable connector on the Radical-7 to connect the Masimo SET® Tester to the Radical-7. See the directions for use that were provided with the Masimo SET® Tester.
www.masimo.com
20
Masimo
Radical-7
Chapter 1: Service and Maintenance
Nurse Call Test To conduct a Nurse Call test 1. 2. 3. 4.
5.
Disconnect any patient cables, sensors, or accessories from the Radical-7. Turn off the Radical-7 and then turn on again. Ensure that there are no audible alarms and that the Audible Alarm feature is not set to silenced. Verify the Nurse Call polarity is set to normal. Connect the common lead of a digital multi-meter to the pin 12 (Nurse Call Common) of the Analog Output connector on the Radical-7. Connect the positive lead of the multi-meter to pin 6 (Nurse Call - Normally Open) of the Analog Output connector and measure that the resistance is greater than 1 MW (open circuit). Trigger an alarm on the monitor (for example, by disconnecting a sensor after it was measuring data). Verify that the resistance is less than 35 ohms.
Analog Output Test To conduct an Analog Output test 1. 2. 3. 4. 5. 6. 7. 8.
Disconnect any patient cables, sensors, or accessories from the Radical-7. Turn off the Radical-7 and then turn on again. Connect the common lead of a digital voltmeter to the pin 2 (Ground) of the analog output connector on the Radical-7. Connect the positive lead of the voltmeter to pin 9 (Analog 1) of the analog output connector. On the device output screen, on the analog 1 option, select 0V Output. See Device Output in Radical-7 Operator’s manual. Verify that the voltmeter measures a voltage of approximately 0V. Change the analog 1 option to 1V Output. Verify that the voltmeter measures a voltage of approximately 1.0V. Repeat steps 5 and 6, with the positive lead of the voltmeter connected to pin 15 (analog 2). See Serial Interface Specifications in Radical-7 Operator’s Manual. Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are between 0V and 1.0V while measuring a saturation and pulse rate.
Battery Test To conduct a Battery test 1. 2. 3. 4.
Fully charge the Radical-7 by placing the Handheld into the Docking Station and then connect the AC power. Verify that the Handheld Battery Charging indicator is illuminated. When the Radical-7 is fully charged, the Handheld Battery Charging indicator turns off. Turn on the Radical-7 on and verify that the Battery indicator shows a full charge.
www.masimo.com
21
Masimo
Radical-7
Chapter 1: Service and Maintenance
Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the instrument repaired. Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning. Make sure the equipment is fully dry before packing. To return the instrument for service, see Return Procedure on page 22.
Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 7. Make sure the equipment is fully dry before packing. Call Masimo (Refer Contacting Masimo) and ask for Technical Services. Ask for an RMA number. Package the equipment securely, in the original shipping container if possible, and enclose or include the following information and items: •
A letter describing in detail any difficulties experienced with the Radical-7. Include the RMA number in the letter.
•
Warranty information, a copy of the invoice or other applicable documentation must be included.
•
Purchase order number to cover repair if the Radical-7 is not under warranty, or for tracking purposes if it is.
•
Ship-to and bill-to information.
•
Person (name, telephone/Telex/fax number, and country) to contact for any questions about the repairs.
•
A certificate stating the Radical-7 has been decontaminated for bloodborne pathogens.
•
Return the Radical-7 to the shipping address listed in Contacting Masimo on page 22
Contacting Masimo Local contact information can be found at http://service.masimo.com.
www.masimo.com
22
Masimo