X12+ Service Manual Rev A1

®

Copyright© 2006 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. X12 is a trademark of Mortara Instrument, Inc.

Table of Contents 1

General Service Manual Purpose ...1-1 User Safety Information...1-1 Periodic Safety Inspections ...1-1 Do Not Mount Product Above Patient ...1-1 Proper patient Cable ...1-1 Recommended Accessories ...1-1 Sterilizing this Product ...1-1 Liquid Spills ...1-1 System Information Log ...1-1 Product Information ...1-1 Symbols Used In This Manual...1-2 Symbol Delineation ...1-2 Technical Support and Service ...1-3 Notices...1-4 Warranty Information ...1-5 FCC Compliance Statement...1-6 Electromagnetic Compatibility (EMC)...1-8

2

Maintenance and Cleaning Introduction ...2-1 Recommended Cleaning Supplies ...2-1 Cleaning and Inspection Techniques ...2-1 Interior Cleaning ...2-1 Metallic and Plastic Parts Cleaning ...2-2 Exterior Cleaning ...2-2 Interior Visual Inspection ...2-2 Preventive Maintenance Schedule ...2-2 Batteries Removal / Installation ...2-3

3

Technical Description X12 Overview ...3-1 Front End Board ...3-1 Transmit Board ...3-1 X12+ Block Diagram...3-2 X12+ Frequency Table For 600 MHz ...3-3 X12+ Frequency Table for 2500 MHz ...3-5

i

4

Disassembly Parts List #1 - Final Assembly 915 MHz ...4-1 Opening the unit ...4-2 Keypad Removal and replacement...4-4 LCD Removal and Replacement ...4-5 X12+ Transmitter Board Removal and Replacement ...4-7 Front End Board Removal and Replacement ...4-8

5

Printed Circuit Boards Introduction ...5-1 Transmitter Board...5-2 Front End Board ...5-3

6

Testing and Troubleshooting Introduction ...6-1 Warning ...6-1 Required Safety Test for Printed Circuit Boards ...6-1 Troubleshooting Table...6-1 Testing ...6-4 Equipment Required ...6-4 Power Up Testing ...6-4 Connection Testing...6-6 ECG Display ...6-8 Unit Configuration ...6-9 Verifying the X12+ is transmitting ...6-10

ii

____________________________________________________________________________Section 1

1

General

Service Manual Purpose The purpose of this manual is to provide information to service personnel in order to maintain the X12+ Transmitter. This manual includes parts lists and is intended to function primarily as a guide to preventative and corrective maintenance and electrical repairs considered field repairable. WARNING: No user serviceable parts are inside. Any modification of this device will void any and all Manufacturer's Warranties and/or responsibilities. If you are not able to correct the X12+ Telemetry Module’s questionable operating state using the Troubleshooting guide in the User Manual, do not attempt to service it yourself. Contact Mortara Service at 1-888-MORTARA (667-8272) or via email at [email protected].

User Safety Information Periodic Safety Inspections Follow the recommended maintenance schedule. Inspect the patient cable(s) 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.

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.

Proper Patient Cable Use only the patient cable specified for this unit.

Recommended Accessories For the patient's safety and optimum equipment performance, use only the accessories specified by/or meet Mortara Instrument, Inc. specifications.

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 X12+, and/or optional equipment.

System Information Log See Appendix "A" of User Manual

Product Information See Section 1 of User Manual

1-1

X12+_______________________________________________________________________________

Symbols Used In This Manual Symbol Delineation

Warning

Caution

Electrostatic sensitive devices

Defibrillator-proof type CF input

Battery

Indicates compliance to applicable EEC Directives

Separate Collection

1-2

____________________________________________________________________________Section 1

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

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]

Community Representative Mortara Instrument GmbH Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Cimarosa 40033 Casalecchio di Reno (BO) Tel: +39.051.298.7811 Fax: +39.051.613.3582 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]

(Germany) Kaninenberghohe 50 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

1-3

X12+_______________________________________________________________________________

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 (Ambulatory X12+) 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.

1-4

____________________________________________________________________________Section 1

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. The warranty period is defined as twelve (12) months following the date of shipment from 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 MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

1-5

X12+_______________________________________________________________________________

FCC Compliance Statement In the United States, use of the X12+ transmitters is regulated by Federal Communications Commission (FCC). FCC ID: HJR-X12-600-15 FCC ID: HJR-X12P-2500 These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions: 1. 2.

This device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation.

•

The X12+ (600) must be used solely on the premises of health care facilities (see Part 15, section 15.242a).

•

A health care facility operating the X12+ (600) must coordinate with the directors of existing nearby TV stations and Radio Astronomy Observatories to ensure compatible use. Minimum separation distances from such facilities may apply. It may be necessary to obtain written authorization from such facilities prior to installation and use of the X12+ (Part 15, section 15.242d,e).

Industry Canada Compliance Statement In Canada, use of the X12+ (600) transmitter is regulated by Industry Canada. Canada ID: 3758104616 This device complies with RSS-210 of the Industry Canada rules. This telemetry device is only permitted for installation in hospitals and health care facilities. Devices shall not be operated in mobile vehicles (even ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Penticton radio astronomy station (British Columbia latitude: 49o 19' 12" N, longitude: 118o 59'56" W). For medical telemetry systems not meeting this 80 km separation (e.g. the Okinagan valley, British Columbia) the installer/ user must coordinate with and obtain the written concurrence of the Director of the Penticton radio astronomy station before the equipment can be installed or operated. The Penticton contact is Tel: 250-493-2277/ fax: 250-493-7767.

1-6

____________________________________________________________________________Section 1

Note •

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

•

Patient cables should be checked for cracks or breakage in their exterior properties prior to use.

•

As defined by IEC 601-1 and IEC 601-2-25, the device is classified as follows: - Internally powered - Type CF applied parts - Ordinary equipment - Not suitable for use in the presence of flammable mixtures with air, oxygen or nitrous oxide - Continuous operation

•

The X12+ is a UL classified device:

Medical Equipment WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY, IN ACCORDANCE WITH UL 60601-1, CAN/CSA C22.2 No. 601.1, IEC60601-1 AND IEC60601-2-25.

5P35

1-7

X12+_______________________________________________________________________________

Electromagnetic Compatibility (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using the X12+ Transmitter. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the X12+ Transmitter according to the international standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2). The X12+ Transmitter should not be used adjacent to, or stacked on top of other equipment. If the X12+ Transmitter must be used adjacent to or stacked on top of other equipment, verify that the X12+ Transmitter operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See Table X-4 for recommended separation distances between the radio equipment and the X12+ Transmitter.

Accessories and Cables Warning The use of accessories and cables other than those specified below, may result in increased emissions or decreased immunity of the X12+ Transmitter. Description

Part Numbers

10-wire LeadForm Patient Cable/ Domestic • Standard • Large

9293-017-50 9293-026-50

10-wire LeadForm Patient Cable/ International • Standard • Large

9293-017-51 9293-026-51

1-8

____________________________________________________________________________Section 1

Table X-1

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

The X12+ Transmitter is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the X12+ Transmitter should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment: guidance

RF Emissions CISPR 11

Group 2

The X12+ Transmitter must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF Emissions CISPR 11

Class B

Harmonic Emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not Applicable

The X12+ Transmitter is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Not Applicable

1-9

X12+_______________________________________________________________________________

Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The X12+ Transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the X12+ Transmitter should assure that it is used in such an environment. Emissions Test

Compliance

Compliance Level

Electromagnetic Environment: guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

+/- 6 kV contact +/- 8 kV air

+/- 6 kV contact +/- 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast transient/burst IEC 61000-4-4

+/- 2 kV for power supply line +/- 1 kV for input/output lines

Not Applicable

Surge IEC 61000-4-5

+/- 1 kV differential mode +/- 2 kV common mode

Not Applicable

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles

Not Applicable

Power frequency (50./60 Hz) magnetic field

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

1-10

____________________________________________________________________________Section 1

Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The X12+ Transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the X12+ Transmitter should assure that it is used in such an environment. Emissions Test IEC 60601 Compliance Electromagnetic Environment: guidance Test Level Level Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the X12+ Transmitter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

⎡ 3.5 ⎤ d=⎢ P ⎣ 3Vrms ⎥⎦ Radiated RF IEC 61000-4-3

3 Vrms 80 MHz to 2.5 GHz

3 Vrms 80 MHz to 2.5 GHz

⎡ 3.5 ⎤ d=⎢ P 80 MHz to 800 MHz ⎣ 3V / m ⎥⎦ ⎡ 7 ⎤ d=⎢ P 800 MHz to 2.5 GHz ⎣ 3V / m ⎥⎦ Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the X12+ Transmitter is used exceeds the applicable RF compliance level above, the X12+ Transmitter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the X12+ Transmitter. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

1-11

X12+_______________________________________________________________________________

Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the X12+ Transmitter. The X12+ Transmitter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the X12+ Transmitter can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the X12+ Transmitter as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter W

Separation Distance According to Frequency of Transmitter (m) 150 KHz to 800 MHz

800 MHz to 2.5 GHz

d = 1 .2 P

d = 2 .3 P

0.01

0.1 m

0.2 m

0.1

0.4 m

0.7 m

1

1.2 m

2.3 m

10

4.0 m

7.0 m

100

12.0 m

23.0 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects, and people.

1-12

____________________________________________________________________________Section 2

2

Maintenance and Cleaning

Introduction This section provides servicing and maintenance instructions for the X12+ Transmitter. Subsequent parts of this section are disassembly, inspection techniques, and cleaning techniques.

Recommended Cleaning Supplies • Anti-static mat & wrist band, properly grounded • Clean, lint-free cloth • Cleaning solvent (10% bleach and water solution) or a blood borne pathogen cleaning agent per applicable OSHA and/or state code.

• • •

DRY, low pressure, compressed air (30 psi) Naphtha Vacuum cleaner, Static Safe

Note: The equipment and solvent mentioned above are standard shop commodities that are available from commercial sources.

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. 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 shop safety and fire precautions. Ventilate all work areas where solvents are used. Store solvents and solventsoaked rags in approved containers. Refer to manufacturers’ instructions on containers for recommended fire-fighting procedures, and make sure that fire-fighting equipment is available.

2-1

X12+_______________________________________________________________________________

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. 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 patient cable. Do not use alcohol on the patient cable. Alcohol may damage the insulation of the patient cable..

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 leads for security of mounting, or deterioration. Check terminals and connections for proper installation, loss or wear. Check the identification nameplate and other decals for legibility. Inspect chassis and covers 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.

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

2-2

Period 6 mo.

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

____________________________________________________________________________Section 2

Batteries Removal / Installation: Remove the battery compartment door. Remove the Battery. Check battery connection terminals for debris and/or corrosion.

CAUTION Be sure that the polarity of the batteries is correct. Follow diagram in cover. Use good quality replacement batteries. The part number for batteries supplied by Mortara Instrument is P/N: 4800-001. Re-install the battery.

2-3

X12+_______________________________________________________________________________

2-4