ELI 150c and ELI250c Service Manual Rev B1

Copyright© 2004 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 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

Europe Economic Community Representative Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Oradour 7 40016 S. Giorgio di Piano, BO Tel: +39.051.6654311 Fax: +39.051.6651012

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument GmbH (Germany) Henricistr. 124 45136 Essen Tel: +49.201.268311 Fax: +49.201.268313 Mortara Instrument B.V. (The Netherlands) H. Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Tel: +31.30.2205050 Fax: +31.30.2201531

24 Hour Technical Support Same Day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

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Notices Manufacturer’s Responsibility Mortara Instrument, Inc., is responsible for the effects on safety and performance only if: • Assembly operations, extensions, readjustments, modifications or repairs are carried out only by persons authorized by Mortara Instrument, Inc. • The device (ELI 250/210) is used in accordance with the instructions for use.

Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards.

Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced.

Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of Mortara Instrument, Inc.

Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument Inc. makes no commitment to update or to keep current the information contained in this document.

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Warranty Information Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara. Normal use, service and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions: a)

Freight damage;

b) Parts and/or accessories of the Products not obtained from or approved by Mortara; c)

Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides;

d) Accident, a disaster affecting the Products; e)

Alterations or modifications to the Products not authorized by Mortara;

f)

Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Products (i) of all carrier charges with respect to any Products returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Products. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm or damage, or the original purchase price of the Product when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANT ABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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User Safety Information Warning:

Caution:

Electrostatic Caution

Means there is the possibility of personal injury to you or others. Means there is the possibility of damage to the equipment. Means that there is the possibility of damage due to electrostatic discharge and appropriate precautions should be taken. Provides information to further assist in the use of the device.

Note:

Federal law restricts this device for sale to or on the order of a physician.

Warning(s) •

Device (electrocardiograph, Class I) captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

•

To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a Hospital Grade outlet.

•

To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.

•

Patient cables intended for use with the ELI 250/210 include series resistance (10 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.

•

Conductive parts of the patient cable, electrodes and associated connections of Type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts, including earth ground.

•

To maintain designed operator and patient safety, only use parts and accessories supplied with the device and available through Mortara Instrument, Inc.

•

ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation.

•

To prevent possible infection, single use components (e.g., electrodes) should be limited to one-time use only.

•

To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

•

To ensure the safety of both the patient and the device, 1.5 meters (5 feet) of open area should surround the patient.

•

A possible explosion hazard exists; do not use the device in the presence of flammable anesthetics.

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•

Before attempting to use the device for clinical applications the operator must read and understand the contents of the manual and any documents accompanying the device.

•

Where the integrity of external protective earth conductor arrangement is in doubt, the ELI 250/210 shall be operated from its internal electrical power source.

•

All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (e.g. IEC 60950), as appropriate to the device. Connecting additional devices to the ELI 250/210 may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured to confirm no electric shock hazard exists.

•

The ELI 250/210 has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient.

•

The quality of the signal produced by the electrocardiograph may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines.

•

The ELI 250/210 uses a lead-acid gel cell battery. Disposal of this battery must be in compliance with governmental regulations. •

This unit can operate using AC power. Caution should be taken when working on this unit to limit the exposure to high voltages. The unit should not be connected to AC power and the battery fuse should be removed when replacing any assembly of this unit.

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Caution(s) •

To prevent possible damage to the keypad, do not use sharp or hard objects to depress keys, only use fingertips.

•

Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth.

•

No user serviceable parts inside. Screw removal by qualified service personnel only.

•

The rechargeable internal battery is a sealed lead acid type and it is totally maintenance free. If the battery appears to become defective, refer to Mortara Instrument Service Department.

•

Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables should be stored after forming them into a loose loop.

Electrostatic Caution • Notes •

Excessive patient movement could interfere with the operation of the device.

•

Proper patient preparation is important to proper application of ECG electrodes and operation of the device.

•

There is no known safety hazard if other equipment, such as pacemakers or other stimulators, are used simultaneously with the ELI 250/210; however, disturbance to the signal may occur.

•

If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s) where this condition is present and if the signal is being printed, the respective lead(s) will print out as a square wave.

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•

As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows: • Class I equipment or internally powered • Type CF applied parts • Ordinary equipment • Not suitable for use in the presence of flammable anesthetics • Continuous operation NOTE: From a safety perspective, per IEC 60601-1 and derivative standards / norms, this unit is declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with mains. The ground terminal on the mains inlet is the only protective earth point in the unit. Exposed metal accessible during normal operation is double insulated from mains. Internal connections to earth ground are functional earth.

•

The ELI 250/210 will automatically turn off (blank screen) if the batteries have been severely discharged.

•

After operating the ELI 250/210 using battery power, always reconnect the power cord. This ensures that the batteries will be automatically recharged for the next time you use the ELI 250/210. A light will illuminate, next to the on/off switch, indicating that the unit is charging.

•

The ELI 250/210 is a UL Classified Device: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, AND IEC60601-2-25

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Table of Contents 1

General Service Manual Purpose ...1-1 User Safety Information ...1-1 Periodic Safety Inspections ...1-1 Proper Power Cord ...1-1 Proper Fuse ...1-1 Do Not Operate in Explosive Atmospheres ...1-1 Use Only Safe Methods of Interconnection ...1-1 Do Not Mount Product above Patient ...1-1 Recommended Accessories ...1-1 Sterilizing this Product ...1-2 Liquid Spills ...1-2 System Information Log ...1-2 Product Information ...1-2 Manual Symbol Delineation ...1-2

2

Maintenance and Cleaning Introduction (Maintenance and Cleaning) ...2-1 Recommended Cleaning Supplies ...2-1 Equipment Required...2-1 Cleaning and Inspection Techniques ...2-2 Interior Cleaning ...2-2 Magnetic Cleaning ...2-2 Printed Circuit Board Cleaning ...2-2 Metallic and Plastic Parts Cleaning ...2-3 Exterior Cleaning ...2-3 Printhead Cleaning ...2-3 Inspection of Writer Assembly Harness ...2-3 Exterior Inspection ...2-4 Interior Visual Inspection ...2-4 Preventive Maintenance Schedule ...2-4

3

System Settings Access Configuration Menu for the ELI 250...3-1 Summary of Configuration Menus...3-3 Configuration Page 1...3-6 Software Version ...3-6 Cart Number ...3-6 Site Number ...3-6 Telephone Number ...3-6 Language ...3-7 Volume...3-7 Battery Timeout ...3-7 Configuration Page 2 ...3-8 Flash Size ...3-8 ID Format ...3-8 AC Filter ...3-8 Paper Speed ...3-8 Filter ...3-9 Height/Weight Units ...3-9 ix

Date Format ...3-9 Plot Format ...3-9 Interpretation Option ...3.9 Reasons...3-10 Configuration Page 3 ...3-10 Append to ECG...3-10 Number of Copies...3-10 ECG Retrieved...3-10 Delete Rule ...3-11 Storage Sensitivity ...3-11 Auto Save ECG...3-11 Auto Print ECG ...3-11 Serial Baud Rate...3-11 Modem Baud Rate...3-11 Use A4 Paper...3-11 Caps Lock ...3-12 Configuration Page 4 ...3-12 Rhythm Leads...3-12 12-Lead Rhythm Printout...3-12 Access Configuration Menu for the ELI 210...3-13 Summary of Configuration Menus...3-16 Configuration Page 1...3-18 Software Version ...3-18 Cart Number ...3-18 Site Number ...3-18 Telephone Number ...3-18 Language ...3-18 Volume...3-18 Battery Timeout...3-19 AC Filter ...3-19 Paper Speed ...3-19 Filter ...3-19 Height/Weight Units ...3-19 Configuration Page 2 ...3-20 Date Format ...3-20 Plot Format ...3-20 Interpretation Option ...3-21 Reasons...3-21 Append to ECG...3-21 Number of Copies...3-21 Use A4 Paper...3-21 Configuration Page 3 ...3-22 Rhythm Leads...3-22 12-Lead Rhythm Printout...3-22

4

Assembly/Disassembly of Unit Fuse Removal ...4-1 Cover Assembly Removal ...4-2 Battery Removal ...4-7 Keyboard/LCD Removal...4-7 Writer Removal / Installation...4-11 Printhead Removal / Installation...4-13 Writer Motor Removal...4-15 Printed Circuit Board Assembly Removal / Installation ...4-17 Front End Board Removal / Installation...4-19

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5

Technical Description Introduction ...5-1 ELI 250/210 Block Diagram...5-2 Main System Board ...5-3 Front End Board ...5-3 Input Connector Pin out...5-4 ELI 250/210 Specifications ...5-5 Parts List...5-6

6

Troubleshooting and Testing Introduction ...6-1 Troubleshooting...6-1 AC Power, Backlight on, Nothing on Display ...6-1 With AC On, Nothing on Display ...6-1 Unit Works on AC but not on Battery...6-1 Unit turns on, No waveform on screen but Function Keys Displayed ...6-2 No Keyboard Functions and Display Frozen...6-2 RS232 Transmit / Receive Problems ...6-2 Optional Modem Transmit / Receive Problems...6-3 Testing ...6-4 Power Supply Test...6-4 Keyboard test...6-4 LCD Test...6-4 Speaker Test ...6-4 Date / Time Test ...6-5 Writer Test ...6-5 Writer Test Description ...6-6 Adjusting the Writer Cue Sensor ...6-6 ECG Test ...6-7 Noise Test...6-7 Lead Fail Test ...6-8 Transmitting Records...6-8 Testing Continued Serial Port Test ...6-10 Modem Test ...6-10 Modem Initialization ...6-10 Receive ECGs ...6-12 WLAN Test...6-13 Safety Test ...6-14

Appendix A ELI 250 Connectivity Chapter Purpose ...A-1 Transmitting records...A-1 Direct Connection ...A-3 Modem Connection ...A-3 WLAN Transmission...A-5 LAN Transmission ...A-6 Patient Request List ...A-11 Custom ID Download...A-13

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Appendix B ELI 250 Connectivity Options Modem Options ...B-1 XIRCOM Modem...B-1 Multitech Modem...B-3 LAN Option ...B-5 Wireless LAN Option ...B-8

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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 250/210 Interpretive and Non-Interpretive 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 250/210 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 250/210 _________________________________________________________________________

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 250/210, and/or optional equipment.

Product Information See Section 1 of Operator's Manual

Manual Symbol Delineation

Electrostatic sensitive devices

Caution or Special Instructions

1-2

____________________________________________________________________________Section 2

2

Maintaining and Cleaning CAUTION: Remove battery fuse before attempting any disassembly. Removal of the battery fuse will not cause a loss of ECGs or of the configuration. This information is stored in FLASH memory.

Introduction This section provides servicing and maintenance instructions for the ELI 250/210 interpretive electrocardiograph. Subsequent parts of this section are disassembly, inspection techniques, cleaning techniques, and installation.

Recommended Cleaning Supplies • Anti-static mat & wrist band, properly grounded • Clean, lint-free cloth • Cleaning solvent (isopropyl alcohol, 99% pure) • DRY, low pressure, compressed air (30 psi) • Electronic safe non-residue solvent, such as Flux-off • Masking tape • Non-metallic, soft-bristle brush • Naphtha • Vacuum cleaner, Static Safe Equipment Required • Screwdriver Philips #2. • Allen Wrench 0.05 inch or a 1.25 mm • Vibra-Tite or similar product to prevent screws from vibrating loose. • Digital Multi Meter (DMM) Note: The equipment and solvent mentioned above are standard shop commodities that are available from commercial sources. If in the performance of normal maintenance or repair, the PCB assembly, AC connector assembly, or writer assemblies are removed or replaced, a leakage test should be performed. See section on testing.

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ELI 250/210__________________________________________________________________________

Cleaning and Inspecting Techniques This section contains instructions for periodic cleaning and inspection of the instrument as preventative maintenance measures. It also contains specific cleaning procedures to be conducted after disassembly. Parts having identical cleaning procedures are grouped under common headings. No special tools are required.

Interior Cleaning WARNING Ventilate work area thoroughly when using solvents. Observe manufacturers warnings on solvent containers with regard to personnel safety and emergency first aid. Be sure that first aid equipment is available before using chemicals. Observe all shop safety and fire precautions.

Magnetic Cleaning CAUTION Do not use solvents to clean transformers or inductors. The chemical action of solvents may remove the varnish from the wire coils, rendering the components useless. The solvent also neutralizes the adhesive of the cover tape, resulting in eventual tape separation from the windings. Clean transformers and inductors with a dry, non-metallic, soft bristle brush.

Printed Circuit Board Cleaning The printed circuit board assemblies in the ELI 250/210 system contain static sensitive devices. Use special handling procedures to prevent damage due to ESD. Clean assembled parts with a vacuum cleaner or low pressure compressed air (30 psi). Take care when cleaning printed circuit boards that wires or component leads are not bent back and forth in such a manner as to weaken them and cause them to eventually break. Dry with low pressure compressed air.

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____________________________________________________________________________Section 2

Metallic and Plastic Parts Cleaning

CAUTION Do not wipe over surfaces of nameplates or labels with abrasive cleaners or materials, as this will eventually wear away the nameplate information. Do not use solvents to clean plastic parts. Brush all surfaces and parts with a nonmetallic, soft bristle brush. Wipe metal surfaces with soft, nonabrasive cloth dampened with isopropyl alcohol. Dry surfaces with clean cloth. Wipe surfaces of nameplates and labels with dry cloth.

Exterior Cleaning Use a damp cloth to clean external covers and the line cord. Do not use alcohol, solvents, or cleaning solutions. These cleaning agents may damage the surfaces of the instrument.

Printhead Cleaning Open the writer cover as explained in the section on final assembly. Apply isopropyl alcohol to a clean cloth, and wipe the writer printhead until all foreign matter is removed. Dry the printhead thoroughly before use. Use a dry clean cloth for this. After cleaning is completed, inspect the unit using the techniques described previously. After the inspection is complete, install the cover as explained in the section on final assembly.

Inspection of Writer Assembly Harness Visually inspect the wire harnesses for wear, maintenance damage, corrosion, deterioration, and damage resulting from dropping. If no defects are found, install the cover and restore the unit to service. If a defect is found in the cables, replace the damaged cable with a new cable.

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ELI 250/210__________________________________________________________________________

Exterior Inspection Visually inspect the entire instrument for wear, maintenance damage, corrosion, deterioration, and damage resulting from dropping.

Interior Visual Inspection Check all connectors for loose, bent or corroded contact points Check wire, harnesses and cables for signs of wear or deterioration. Inspect components and their leads for security of mounting, deterioration or leakage. Check terminals and connections for proper installation, failed soldering, loss or wear. Inspect PCB surfaces for charring, cracking or brittleness. Note: Some degree of discoloration of the PCB surface may be expected due to continued exposure to the operating temperatures of some of the components. Check the identification nameplate and other decals for legibility. Inspect chassis, covers, and brackets for warping, bending, surface damage or missing captive hardware. Check all screws and nuts for tightness or signs of stripped or crossed threads. Check for any other form of mechanical damage, which may indicate a failure. If, during the process of normal maintenance or repair, the PCB assembly, AC connector assembly, or writer assembly are removed and replaced, perform the leakage test as describe in the section on Testing and Troubleshooting.

Preventative Maintenance Schedule: Maintenance to be Performed Clean and inspect unit.

Period 6 mo.

Notes Perform every 3 mo. if unit is in heavy use.

Printhead cleaning

80 hrs

Monthly cleaning recommended

Leakage tests.

-

As required by facility or regulatory requirements. Table 1

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