Service Manual
89 Pages
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Page 1
REF 9516-171-50-ENG Rev D1
ELI 350 12-LEAD RESTING ELECTROCARDIOGRAPH
SERVICE MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician
Copyright © 2007-2011 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc.
TECHNICAL SUPPORT AND SERVICE Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com
European Union Representative Mortara Rangoni Europe, Srl (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582
Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected] 24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts
Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument Germany Kaninenberghöhe 50 45136 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Randweg 4 5683 CL Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Unit 11, 7 Inglewood Place Baulkham Hills NSW 2153 Australia Tel: +61 2 8824 5499 Fax: +61 2 8814 5399
Table of Contents:
1
General User Safety Information ………………………………………………………………… 1-1 Symbol Delineation ...…………………………………………………………………… 1-2
2
Maintenance and Cleaning Preventive Maintenance Procedure……………………………………………………. 2-1 Device Cleaning and Disinfecting………………………………………………………. 2-4 Safety Testing…….….…………………………………………………………………… 2-5
3
Assembly/Disassembly of Unit Special Instructions and Cautions ……………………………………………………. 3-1 Base Unit assembly / disassembly ………...…………………………………………. 3-2 Base assembly parts list ………...……………………………………………………. 3-36 LCD assembly / disassembly ………...………………………………………………. 3-37 LCD assembly parts list ………...………………………………………………. 3-53 Writer assembly / disassembly ………...……………………………………………. 3-54 Writer assembly parts list ………...……………..……………………………………. 3-66
4
Troubleshooting and Testing ELI350 Troubleshooting ………………………………………………………………… 4-1 ELI350 Testing ………………………..………………………………………………… 4-3 Cue Sensor Adjustment ………………………………………………………………. 4-4 Modem Country Codes ..……………………………………………………………… 4-8 Safety Tests ……………………………………………………………………………… 4-9
5
Options & Upgrades Upgrade Options ………………………………………………………………………… 5-1
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____________________________________________________________________________Section 1
1
General
Service Manual Purpose The purpose of this manual is to supply information to service personnel so they can maintain the ELI 350 Electrocardiograph at the assembly and subassembly level. Although the manual includes parts lists, mechanical assembly parts, and printed circuit board information, it is intended to function primarily as a guide to preventative and corrective maintenance and electrical repairs considered field repairable.
User Safety Information Periodic Safety Inspections Follow the recommended maintenance schedule. Inspect the power cord and transmission cables periodically for fraying or other damage and replace as needed. Broken or frayed wires may cause interference or loss of signal. Pay particular attention to points where wires enter connectors.
Proper Power Cord Use only the power cord specified for the equipment. This product requires a three-wire, (18 gauge, SJTgrade) power cord, which is supplied with a three-terminal, polarized plug (hospital grade) for connection to the power source and protective ground. Use only a power outlet with a protective ground outlet. An interruption of the grounding connection could cause an electrical shock hazard.
Proper Fuse Use only the fuse specified for the equipment (identical in type, voltage and current rating). Substituting a different fuse type could cause a fire hazard. Always make sure fuses have been installed before operating the unit.
Do Not Operate in Explosive Atmospheres Do not operate the ELI 350 in the presence of flammable gasses or anesthetics; this environment could cause an explosion. Refer to Operator's Manual Safety Information: Warning(s) and Caution(s).
Use Only Safe Methods of Interconnection To prevent electrical shock from the product when it is connected to other electrical equipment, proper grounding is essential. Refer to Operator's Manual Safety Information: Warning(s) Peripheral equipment.
Do Not Mount Product above Patient Do not mount or place the product where it could fall on a patient or where it could be accidentally knocked off a shelf or other mounting arrangement.
Recommended Accessories For the patient's safety and optimum equipment performance, use only the accessories specified by Mortara Instrument, Inc.
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ELI 350__________________________________________________________________________
Sterilizing this Product Do not sterilize this product or any accessories unless specifically directed by the manufacturer. Sterilization and sterilization environments can seriously damage many components and accessories.
Liquid Spills Do not set beverages or other liquids on or near the ELI 350, and/or optional equipment.
Product Information Refer to the User’s Manual
Manual Symbol Delineation
Electrostatic sensitive devices
Caution or Special Instructions
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____________________________________________________________________________Section 2
2
Maintenance and Cleaning
Preventive Maintenance Preventive maintenance is recommended to be performed on the ELI350 cardiograph once every 12 months. A preventive maintenance report to document the maintenance activity performed is located at the end of this section of the manual.
Warning: Preventive maintenance is to be performed by Mortara authorized service personnel only.
Maintenance Procedure: •
Turn on the cardiograph and print the unit configuration information from the “System Settings” page.
•
Remove the upper housing per section 3 of this manual.
•
Remove the four (4) screws from the writer assembly, without disconnecting the cables, to perform the complete visual inspection below.
•
Perform a visual inspection of the following items: o
Enclosure/Housing – Look for damage or cracks in the external housing or enclosure that could possibly expose the device to the introduction of foreign objects or fluids. Attention should also be paid to areas that could expose an operator or patient to internal circuitry of the device.
o
Contamination – Look for any contamination that may have occurred over time that could not be seen with the housing in place. Fluid damage (perhaps caused during device cleaning) Debris on or behind display shield Battery leakage (lithium and main battery)
o
Internal Cabling – Look for cracked, pinched or partially disconnected cable connections.
o
Fuse Ratings – Verify the battery and AC line fuses match the device labeling.
o
Markings and Labeling – Verify all labels and device markings are clearly visible and legible to the device user and have not been worn off or rendered unreadable through the use of harsh cleaning agents.
o
Integrity of Mechanical Parts – Verify the following items are properly secured to the device and have not become loose or damaged through usage over time. AC Inlet Patient Input Connector Communication ports and antenna Writer mechanics/latching mechanism LCD Assembly
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ELI 350__________________________________________________________________________
•
Power Testing o
Note battery age (if possible) This information can be found on the “date code” sticker on the battery (use the earliest crossed out on the label); or on a sticker located on the bottom of the unit.
date
Based upon customer usage, and the age of the main battery, replace as needed and place a sticker on the bottom of the unit to identify when the battery was replaced. If the internal lithium battery is older than 5 years it should be replaced and a sticker should be placed on the bottom of the unit to identify when the lithium battery was replaced.
Ensure the battery is fully charged before performing the battery tests; the test limits are based on a fully charged battery. Disconnect the AC power cord to begin this section of tests. With the upper housing off of the unit, disconnect the battery cable from the positive terminal. o
Battery Open Circuit – Measure the open circuit battery voltage using a volt meter across the battery terminals, the meter should read greater than 12.5vdc.
o
Battery w/Load – Measure the battery voltage using a volt meter with a power resistor load (10ohm, 20watt) across the battery terminals. After loading the battery for approximately 5 seconds, the meter should read greater than 11.7vdc.
o
Off Current – Connect a current meter in line with the positive battery terminal to the motherboard. With the unit in the “off” state the meter should read less than 450 micro amps.
o
On Current – Set the current meter to a setting greater than 5 amps, and turn the unit on. Once the unit powers up to the main menu, the current should read less than 2.7 amps.
o
AC Charging Current – Insert the AC power cord and verify that the current draw from the battery reverses polarity (starts to charge the battery) and the value starts decreasing in magnitude as time increases.
o
Battery Charger Output Voltage – Disconnect the current meter and measure the battery charger output voltage between the disconnected positive battery cable and the negative battery terminal. It should read between 13.0 and 14.0vdc.
Reconnect the battery cable to the positive terminal and verify all other internal cables are properly connected. Install the writer assembly screws and the upper housing on the cardiograph.
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____________________________________________________________________________Section 2
•
Functional Testing o
AC/DC LED Connect a power source to the AC inlet of the UUT. Verify the AC LED on the keyboard illuminates continuous. With the display in the upright position, turn the unit on. The BATTERY LED will illuminate continuously if the battery is charging, it will turn off when the battery is fully charged or when the display is completely lowered.
o
LCD/Tilt Switch Verify the LCD backlight is on and there are no flickering or missing lines/pixels. Slowly lower the LCD, verify the backlight turns off before or it is completely lowered. Raise the LCD and verify the backlight turns back on.
o
Writer Open and close the writer drawer. Verify smooth operation of the drawer. Verify that the drawer unlatches without sticking. Verify that the drawer latches completely. From the main screen, click on SETTINGS, enter PASSWORD “Print test” and then press the Enter key. Verify that a test page is printed and the writer stops on the cue mark. The perforation on the paper should line up with the tear edge on the UUT. Assure there are no gaps in the print and darkness is uniform across the entire page. Verify no gear skipping and proper paper tracking as the writer prints (you might need to print 3 or more pages to verify this).
o
ECG & Keyboard Matrix Using a Mortara 10-lead patient cable, connect an ECG simulator to the UUT. Set the simulator to an appropriate heart rate and amplitude to enable visual confirmation of the correctness of the ECG printout (comparison to a sample printout from a “known good” device is recommended). Press the AUTO key to capture an ECG. Enter Last Name “PARCFL8”, click on OK to continue and then print the ECG. NOTE: “PARCFL8” ensures the keyboard matrix is fully tested. Verify there is an audible beep with each key press.
Verify that 12 ECG traces print with the correct heart rate, amplitude and morphology, then assess the overall print out quality (ensure there is uniform darkness across entire printout).
o
ECG Noise Test Connect a Shorting Block (TF-0063) or equivalent to the UUT and set the ECG gain to 20mm/mV. Print a Rhythm strip (approx. 1 page). Verify that no channels have more than 0.5mm of baseline noise.
o
Communication options Transmit a test ECG record to a compatible receiving device for all of the applicable communication options enabled below: • Modem • LAN • WLAN
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ELI 350__________________________________________________________________________
Device Cleaning & Disinfecting
Warning: • • • • •
Use of non-recommended cleaning agents or practices could cause damage to the device or possible compromising of the electrical isolation of the device. Makes sure all cables and accessories are disconnected from the device prior to performing cleaning process. Do not immerse the device in liquid. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may damage equipment surfaces. Do not use excessive amounts of liquid during cleaning or disinfecting of the device, as these fluids could enter the device housing and cause damage to the device.
Recommended Supplies: • • • • •
Clean lint free cloth Mild detergent Luke warm water 10% Household bleach and water solution (Sodium Hypochlorite solution consisting of a minimum 1:500 dilution and maximum of 1:10 dilution for disinfecting use only) Isopropyl alcohol or alcohol wipe
Device Cleaning: Disconnect the AC power cord from the device. Clean the exterior surface of the device with a damp (not wet), soft, lint-free cloth using a solution of mild detergent diluted in luke warm water. After cleaning, thoroughly dry off the device with a clean, soft cloth or paper towel. Open the writer door and wipe the thermal print head clean with a moist alcohol pad and allow it to air dry.
Device Disinfecting: Clean the device per the instructions defined above, then wipe the exterior of the device with a damp (not wet), soft, lint-free cloth using a solution of 10% bleach and water. Allow the device to air dry after disinfecting before returning to use.
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____________________________________________________________________________Section 2
Safety Testing The following safety tests should be performed in accordance with IEC 60601 or IEC 62353 standards and all local regulatory requirements: • • • • •
Earth Leakage Enclosure Leakage Patient Leakage Patient Leakage Type-F Patient Auxiliary Current
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Mortara Instrument Inc.
Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, WI. 53224
Phone (414) 354-1600 Fax (414) 354-4760
ELI350 Preventive Maintenance Report Unit Serial #: _________________________________________ □
Print device configuration
□
Remove upper housing and writer assembly
□
Perform Visual Inspection □ Enclosure/Housing □ Contamination □ Cabling □ Fuse Ratings □ Markings and Labeling □ Integrity of Mechanically Parts
□
Power Testing □ Note Battery Age (If Possible)
_____/_____ (week/year)
(Based upon customer usage and age of main battery, replace as needed)
□ □ □ □ □ □
Battery Open Circuit Voltage _______ VDC Battery Load Test _______ VDC OFF Current _______ uA On Current _______ A AC Charging Current (reverses polarity and decreases in magnitude) AC Charging Voltage _______ VDC
□
Check age of Lithium Battery (replace if older than 5 years)
□
Verify all power cables are properly reconnected and reassemble unit
□
Functional testing □ AC/DC LED Operational □ Display Functionality □ Writer Test □ ECG & Keyboard Matrix Testing □ ECG Noise Test □ Communication Options
□
Device Cleaning
□
Safety Testing PASS / FAIL (circle) □ Earth Leakage □ Enclosure Leakage □ Patient Leakage □ Patient Leakage Type-F □ Patient Auxiliary Current
Technician or Field Service Engineer: ____________________________ Date: _____/_____/_____
____________________________________________________________________________Section 3
3
Assembly / Disassembly
Special Instructions The following section defines the assembly of the ELI350 electrocardiograph; disassembly should be performed by reversing the assembly process per these instructions. This assembly procedure describes the use of Vibra-Tite on some threaded parts. The Vibra-Tite must dry for a minimum of 10 minutes before assembly. The Vibra-Tite may be applied to the threaded pieces ahead of time and allowed to dry. This way the parts will be available for assembly when needed. If the parts already have Vibra-Tite, this process can be skipped. Before applying all adhesive backed materials, clean surface with alcohol to make sure it is clean and oil free. Torque specifications for all fastening devices shall be 3.5-4.0 lbs-in, unless otherwise noted. Note: Item numbers refer to the parts lists at the end of each assembly section. Cautions CAUTION: Risk of Explosion - DO NOT SHORT Battery Terminals. Leave protective covers on the terminals until assembly into the base unit. CAUTION: Risk of Shock – Line voltage may be present on the Motherboard. DO NOT touch components on the motherboard when performing confidence testing at the sub-assembly level. Caution: Risk of injury – The ELI 350 weighs approximately 30 lbs. Use proper lifting techniques. ATTENTION: The ELI 350 contains ESD Sensitive sub-assemblies. Observe ESD handling techniques when working with electronic assemblies. ATTENTION: Pay particular attention to the positioning of the transformer wires on the motherboard to ensure the wires are not pinched during the assembly of the motherboard to the lower housing. ATTENTION: Prevent pinching of all cables and harnesses by inspecting for proper routing during final assembly.
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ELI 350__________________________________________________________________________
LCD Display Sub-Assembly Instructions for the assembly of the LCD display begin on page 3-35. Writer Sub-Assembly Instructions for the assembly of the 8” thermal writer begin on page 3-52. Base Assembly Note: Installation of optional communication hardware (Ref sections: Modem Option, WLAN Option) requires soldering components to the motherboard prior to installing the motherboard into the Base Assembly. Note: It is recommended to apply all the applicable labeling (Ref section: ELI 350 Labeling) during the Base Assembly process. Insert the blank bulkhead Front Closure Plate (Item 6) in to the Lower Housing (Item 3) and snap in place.
3 6
Flip the Lower Housing over and secure the Front Closure Plate to the Lower Housing using 2 screws (Item 30). Use a T9 bit. Torque Spec: Hand Tighten Only
30 2 Plcs – Torque Spec: Hand Tighten Only
3-2
____________________________________________________________________________Section 3
Apply the Rubber Feet (Item 22, 8 Plcs) to the Lower Housing in the recessed areas provided.
22 8 Plcs
Insert the Fuse Holder Assembly (Item 17) and Fuse (Item 16 or 32 {see note below}) into the Lower Housing. Ensure the Fuse Holder insert is fully clockwise and locked in place.
17
35 16
32
IMPORTANT – The battery fuse on the ELI350 unit is dependant upon the item number of the unit’s motherboard. Units manufactured with the older motherboard (Item #26025-076-51) use a 5A fuse; and those manufactured with the newer motherboard (Item # 26025-076-52) use an 8A fuse. Fuse labeling shown above is for the 5A fuse application; fuse rating labels (Item # 35) are available to properly label the unit chassis if a fuse rating change is required, due to a motherboard service replacement. 3-3
ELI 350__________________________________________________________________________
Insert the SIM Card Access panel (Item 27) into the Lower Housing and secure with screw (Item 18).
27
18
Flip the Lower Housing back onto the rubber feet. Insert the Speaker (Item 12) as shown. Remove the paper backing from one side only and secure the Speaker to the Lower Housing with a piece of Foam Tape (Item 23). 23
12
3-4
____________________________________________________________________________Section 3
Install Front End PCB (Item 14) into Lower Housing and secure in place with 2 screws (Item 19) and 2 screws (Item 20). 14
20
19
14a
If the 10K+ AUXILIARY PCB ASSY (Item 14a) is needed for the 15 lead option, install the 10K+ AUXILIARY PCB ASSY onto Front End PCB (Item 14) prior to installation of Front End PCB (Item 14) Assy. *Note – This option can only be installed on the -52 and -53 motherboards; the hardware on the -51 motherboard does not support this option. 3-5
ELI 350__________________________________________________________________________
Communication Option Installation Installation of optional communication hardware requires soldering components to the motherboard prior to installing the motherboard into the Base Assembly. Additional items will also need to be installed depending on the required option Ref sections: Modem Option, WLAN Option for installation instructions. Apply Cable Tie Mount (Item 29) to bottom side of ELI 350 Motherboard under the LCD signal cable connector location as shown.
29
CAUTION: Motherboards labeled as item # 26025-076-51 (original PCB layout) utilize the transformer shown below. The transformer wires MUST be positioned away from the secondary circuit and any mounting bosses to ensure wires are not pinched during assembly. Motherboards labeled as item # 26025-076-52 utilize a different transformer design that eliminates the possibility of this potential hazard. Bottom View
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Top View
____________________________________________________________________________Section 3
Install the ELI 350 Motherboard (Item 15) into the Lower Housing. Secure in place with 4 screws (Item 19) and 4 screws (Item 20). 20
19
4 Plcs
4 Plcs
15
20
19
19
19
Ensure Lithium Battery is properly soldered to the Motherboard as shown. Battery – Positive Side Up
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ELI 350__________________________________________________________________________
Ensure Power Line Fuses are installed and properly inserted into holder. Rotate the insert fully clockwise to lock the fuse in place. Ensure Ground Label is applied to any of the flat surfaces of the AC Power Inlet connector. Fuses Rotate insert fully clockwise 33 Ground Label
34
AC Line fuses are dependant upon the item number of the unit’s display. Units manufactured with the older display (Item # 5400-016) use T1A fuses; and those manufactured with the newer display (Item # 5400-017) use T2A fuses. Fuse rating labels for the exterior housing (Item # 35) are available for service use when modifying original unit configurations.
Install the Front End Ribbon Cable (Item 11). Connect each end to the applicable PCB assembly and route the cable as shown.
11
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