Welch Allyn CP300 Service Handbook

Welch Allyn CP300 Service Handbook

12 channel ecg recorder
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CP300
12 Channel ECG Recorder
Service handbook

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Summary of Contents for Welch Allyn CP300

  • Page 1 CP300 12 Channel ECG Recorder Service handbook...
  • Page 2 4341 State Street Road, PO Box 220 Skaneateles Falls, NY 13153-0220 www.welchallyn.com Sales and Service information: For information about any Welch Allyn product, please call Welch Allyn Technical Support: 1 800 535 6663 + 1 315 685 4560 Australia + 61 29 638 3000...
  • Page 3: Table Of Contents

    Symbols Used on the Device ............10 Terms of warranty .............. 10 Introduction ..........11 Standard Features .............. 11 Options ................11 Main Components of the CP300........12 Operating Philosophy ............12 Default Login Codes............13 Keypad................. 14 External Connections............15 2.7.1...
  • Page 4 Service handbook CP300 Functional Checks ......... 26 Service interval ..............26 General Unit Integrity Check ..........27 6.2.1 Procedure..................27 6.2.2 Continuous Printout (Internal thermal printer only) ......28 Functional Checks and Tests ..........29 6.3.1 External Sight Control ..............29 6.3.2...
  • Page 5 Construction Drawings ......75 12.1 Upper Assembly ..............75 12.2 LCD Assembly ..............76 12.3 Lower Casing ..............77 12.4 Interconnections..............78 12.5 Isolation Diagram ............... 79 12.6 EMC Concept ..............80 Checklist ..........81 13.1 CP300 checklist table ............81 Page 5...
  • Page 6 Service handbook CP300 Page 6...
  • Page 7: Safety Notes

    Intended Use  The CP300 is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG Recordings. Recordings made with the CP300 can be used as a diagnostic aid for heart function and heart conditions. The CP300 is designed for indoor use and can be used for all patients of both sexes, all races, and all ages.
  • Page 8: Safety-Conscious Operation

    – Ruptured fuses must only be replaced with the same type and rating as the original. Operation with other Devices  Use only accessories and other parts recommended or supplied by Welch Allyn. Use of other than recommended or supplied parts may result in injury, inaccurate information and/or damage to the unit.
  • Page 9: Safety Symbols And Pictograms

    Safety Notes Service handbook CP300 Safety Symbols and Pictograms Safety Symbols and Pictograms 1.7.1 Symbols Used in this Document The safety level is classified according ANSI Z535.4. The following overview shows the used safety symbols and pictograms used in this manual.
  • Page 10: Symbols Used On The Device

    Attention: Consult accompanying documents. Terms of warranty The Welch Allyn CP300 is warranted against defects in material and manufacture for the duration of one year (as from date of purchase). Excluded from this guarantee is damage caused by an accident or as a result of improper handling. The warranty entitles free replacement of the defective part.
  • Page 11: Introduction

    Service handbook CP300 Standard Features 2 Introduction The Welch Allyn CP300 is a diagnostic workstation designed to record, display, archive, present, and analyse ECG recordings and other measurements. 12-lead resting ECG recordings give measurements, interpretation, average cycles and rhythm sections as standard. Exercise testing includes predefined stress protocols and dedicated keys for treadmill control.
  • Page 12: Main Components Of The Cp300

    Operating Philosophy The operating philosophy of the CP300 is that users are allocated user rights which allow access to specific functions. Several user levels are available. It is the system administrator / Manufacturers technician who defines the users and allocates the user level.
  • Page 13: Default Login Codes

    Introduction Service handbook CP300 Default Login Codes Default Login Codes There are default login codes for Manufacturers technician and Administrator login levels. Only Manufacturers technician login level has access to unit firmware update, software option update and other menu options. The default logins are as...
  • Page 14: Keypad

    Introduction Keypad Keypad 11 12 13 14 The keyboard can be slightly different depending of what version was delivered. Part. nr. 4.150076 = WA PN 714279 Part. No:4.150231 (1) Alpha-numeric keyboard. The keys F1 to F10 have varying functions depending on use (see page 18).
  • Page 15: External Connections

    Service handbook CP300 External Connections External Connections  All externally connected hardware must be approved by Welch Allyn. Connection of any hardware not approved by Welch Allyn is at the owner‘s risk. The unit guarantee may also be invalid. 2.7.1 Back Panel (1) Four USB connectors (Universal Serial Bus (version 1.1 protocol)).
  • Page 16: Side Panel

    Introduction External Connections 2.7.2 Side Panel The connection for the ECG patient cable is situated on the right hand side panel of the unit. © • The patient cable and connector is CF rated, that is fully floating and isolated, defibrillation protected, suitable for intra-cardiac application.
  • Page 17: The Display

    Introduction Service handbook CP300 The Display The Display Example of the Patient Screen Example of an aquisition Screen (exercise) The display will vary according to the current task being carried out. In all screens however, the top, middle and bottom areas display the same information groups. The following gives examples of the patient screen and the exercise acquisition screen.
  • Page 18: Function Keys

    Function Keys Function Key Table 3 Function Keys Function Key Table Patient Screen Recording Screens View Screens Function Key Resting ECG Exercise ECG Resting ECG Exercise ECG  Start Emergency <Ctrl> F1 Acquisition Screen  Edit Patient  Edit Patient ...
  • Page 19: Operation

    • Do not allow the unit to come into contact with acidic vapors or liquids. • The CP300 should not be placed in the vicinity of X-ray or diathermy units, large transformers or electric motors.
  • Page 20: Switching On And Off

    Operation Start-up and Initial Preparation 4.1.4 Switching ON and OFF The unit is switched on and off with the On / Off key. 4.1.5 Power Supply and Backup Battery Operation The unit is operated from the mains supply. When mains is connected the mains On / Off Key indicator is lit.
  • Page 21: Glide Point Controller Operation

    4.2.1 Connecting a Mouse or Trackball Device The CP300 can work with an external point and control device. When a mouse or trackball etc. is connected (to the PS-2 connector on the back panel), the glide point controller operation is disabled.
  • Page 22: Changing The Printing Paper

    • Certain glues can react with the paper - do not attach the printout onto a mounting sheet with glue. Welch Allyn can only guarantee perfect printouts when CP300 original chart paper or chart paper of the same quality is used.
  • Page 23: Physical And Functional Overview

    The ECG board provides isolated patient connection and initial processing of the ECG signals. The operating system in the CP300 is Windows® NT or XP. The user interface, all settings, graphical presentations etc. are based on Windows®. The evaluation of the ECG data, control of the printer and other functions are realised on the Welch Allyn ECG processor card with its own 68331 microprocessor system.
  • Page 24 Physical and Functional Overview Functional Overview CP-300 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 1 2 3 1 2 3 1 2 3...
  • Page 25 Physical and Functional Overview Service handbook CP300 Functional Overview Note: The connector designations given here are liable to change. 1 2 1 2 1 2 1 2 1 2 3 PC Single Board 1 2 3 1 2 3 Computer...
  • Page 26: Functional Checks

    Every 6 months • General unit integrity check (see following). • The visual, general, measuring and calibration tests and checks ac-  By Welch Allyn authorized Every 12 months cording to the checklist at the end of this book (see page 81).
  • Page 27: General Unit Integrity Check

    It is not a full functional test but is intended to provide a general confidence check in all the main functional areas. Comprehensive instructions for operating the unit are provided in the CP300 User Guide. This are available from Welch Allyn on request.
  • Page 28: Continuous Printout (Internal Thermal Printer Only)

    Functional Checks General Unit Integrity Check 6.2.2 Continuous Printout (Internal thermal printer only) Manual real-time printout is not available on an external printer because the data processing of inkjet and laser printers is too slow for real time print. When a continuous real-time printout of the ECG is required, it is always printed on the internal thermal printer.
  • Page 29: Functional Checks And Tests

    Functional Checks Service handbook CP300 Functional Checks and Tests Functional Checks and Tests 6.3.1 External Sight Control Required equipment • None 6-monthly Check the following: • Mechanical condition of the device: – no cracks or chips in the casing. – mains, patient and all other cable assemblies are in good condition with no crushing, chafing or cuts, etc.).
  • Page 30: Mains And Battery Indicators (Led) Test

    Functional Checks Functional Checks and Tests 6.3.2 Mains and Battery Indicators (LED) test The internal battery provides power for a limited time. The length of time will depend on many factors enough including battery age, condition, charge, and temperature The battery indicator is lit when running on battery power and blinks when the battery capacity is low.
  • Page 31: Lcd Screen Test

    Functional Checks Service handbook CP300 Functional Checks and Tests 6.3.5 LCD Screen Test • Visually check the screen for spots, or black fields. If many are apparent, the LCD must be replaced (a few faulty pixels is normal). • Check that the LCD shade (contrast and brilliance) is even and the same all over.
  • Page 32: Printer Checks

    3. The paper must stop exactly at the perforation. If this is not the case: – Check that CP300 paper is used. – Clean the paper detection opto window with an alcohol solution.
  • Page 33: Ecg Amplifier And Patient Cable Test (Electrode/ Lead Resistance)

    Functional Checks Service handbook CP300 Functional Checks and Tests 6.3.7 ECG Amplifier and Patient Cable Test (Electrode/ Lead Re- sistance) This gives electrode dc offset and is the voltage drop in the patient cable and electrodes. The result column gives the detected voltage for each electrode in millivolts measured between the electrode on the left leg and each of the individual electrodes.
  • Page 34: Ecg Printout Reference

    Functional Checks Functional Checks and Tests 6.3.8 ECG Printout Reference Required Equipment • Calibrated test ECG Patient Simulator (e.g Müller & Sebastiani MS410 ECG Sim- ulator) IMPORTANT! • The measurement devices listed above are subject to the instructions according to ISO Standards in regards to Test Equipment Control.
  • Page 35 Functional Checks Service handbook CP300 Functional Checks and Tests Reference Printout (Waveform and Intervals) Page 35...
  • Page 36 Functional Checks Functional Checks and Tests Reference Printout (Measurements) Page 36...
  • Page 37: I / O Port Checks

    • RS-232 test plug. I/O Test Program The test program is found on the hard disk of the unit: C: Drive (CP300) > Service > Test > Commport.exe CP300 RS Test Plug Using an RS plug, solder together pins 2 and 3.
  • Page 38: Checking The Rs-232 Ports

    Failed to open without the unit being plugged in Com 4 will show always “Failed to open”, because it is not used. If “Failed to open” is displayed, the port is occupied by an application running on the CP300. Exit this application and try again. Page 38...
  • Page 39: Safety Tests

    Functional Checks Service handbook CP300 Safety tests Safety tests Required equipment • Safety Tester IEC/EN 60601-1 • Bender Safety Tester (recommended) • HA2000D High voltage measuring unit (recommended) IMPORTANT! The measurement devices listed above are subject to the instructions according to ISO Standards in regards to Test Equipment Control.
  • Page 40: Software, Firmware And Test Screen

    QRS Trigger / DC Input / DC Output Function Freeze On Show Start Recording Dialogue Emergency ECG R ti The CP300 does not have a CDROM drive so uploads / downloads the CP300 is over a network, USB memory stick, etc. Page 40...
  • Page 41: Unit Settings

    Software, Firmware and Test Screen Service handbook CP300 Unit Settings Unit Settings 7.1.1 Importing / Exporting / Reset to Default It is possible to export and import the unit settings (color, default speed etc., but not language and some other settings). These can then be used to define the settings of any unit, for example, to set the same unit settings for all units in a department / hospital, etc.
  • Page 42: Updating Firmware

    Unzip and copy the file on the desktop / memory stick / network folder. Click the Start Firmware Update icon. The following is displayed: CP300 CP300 Click the browse button to locate the firmware file (.abs file) and install in the normal way.
  • Page 43: Updating The Unit Options

    Software, Firmware and Test Screen Service handbook CP300 Updating the Unit Options Updating the Unit Options The Exercise and Interpretation options are already prepared in the software and are activated by entering an upgrade code. 1. Click the Start Option Update (a) icon. The following screen is displayed:...
  • Page 44: Tests Screen

    When the test screen is entered a code can be entered to perform certain functions. The test screen is a development tool and is not intended for service personnel and the codes given here are for information only. CP300 CP300 The codes are as follows:...
  • Page 45: Replacing Major Components

    Replacing Major Components Service handbook CP300 Safety Notes 8 Replacing Major Components Safety Notes  Danger of electrical shock. Remove mains cable. When working on a open device connect the device via an isolation transformer.  Follow the procedures for the prevention of accidents and environmental protection according your national guidelines.
  • Page 46: Opening The Unit

    Replacing Major Components Opening the Unit Opening the Unit The top and bottom assemblies are secured with seven recessed screws. Access to the screws is gained from the underside of the unit. To separate, proceed as follows: Turn the unit up-side-down and rest on a soft antistatic cloth. Unscrew and remove the countersunk retaining screws and washers situated in the extreme corners and edges of the unit.
  • Page 47: Main Board Mk 17-1 & Pc1-1 Board

    Replacing Major Components Service handbook CP300 Main Board MK 17-1 & PC1-1 Board Main Board MK 17-1 & PC1-1 Board 1. Remove the EMC shield by unscrewing the securing screws. 2. The ETX base board processor os positioned on the PC1-1 single processor board that is located on spacers on the main board (MK17-1).
  • Page 48: Ecg Board Mk 16-2

    Replacing Major Components ECG Board MK 16-2 ECG Board MK 16-2 Unscrew the EMC shield and remove Remove the connector to the Main Board (P30) Unscrew the four board retaining screws. Remove the two screws securing the patient connector to the casing. Remove the Board.
  • Page 49: Reassembling The Unit

    Replacing Major Components Service handbook CP300 Reassembling the Unit Reassembling the Unit 8.8.1 Internal Sight Control If the device has been opened, the device must be given a full sight control before it is screwed back together. Check following items: •...
  • Page 50: Unit Settings

    9 Unit Settings Settings at Administrator login level Detailed in this section are all settings available at Administrator login level. 9.1.1 System Settings CP300 System Login/Startup, Users, Institutes, Departments General Filter QRS Trigger / DC Input / DC Output Function Freeze On...
  • Page 51 Unit Settings Service handbook CP300 Settings at Administrator login level Parameter Options Description Language / Language Select language of choice. This changes the program language immediately Formats without rebooting. All operating system dialogues however, (e.g. printer setup), will remain in the language of the operating system.
  • Page 52 Select the Remote active box (1) to store recordings remotely (i.e. not on the CP300 database, for example on SEMA-200). select the Local / Wireless box if the SEMA-200 database is installed on the CP300 hard drive. If the SEMA program is installed on a network, do not select this box.
  • Page 53 Options Description General Check the shut down the computer after quitting the CP300 box to shut down (1) Switch Off Mode the unit directly when the program is exited. If this box is not checked, the unit will enter the Windows environment when the CP300 program is exited. To display a prompt screen before exiting the program, check the Confirm CP300 shutdown box.
  • Page 54: Login/Startup, Users, Institutes, Departments

    If you wish to skip the login screen and go directly into the program when the Login unit is first switched on, check the 'skip the login...' box, and specify the user. When the unit is next switched on the CP300 will automatically login with the defined user. Institutes /...
  • Page 55: Ecg

    Unit Settings Service handbook CP300 Settings at Administrator login level 9.1.3 Settings System Login/Startup, Users, Institutes, Departments General Filter QRS Trigger / DC Input / DC Output Function Freeze On Show Start Recording Dialogue Emergency ECG Resting ECG Parameter Options...
  • Page 56: Settings At Physician/Administrator Level

    Unit Settings Settings at Physician/Administrator level Settings at Physician/Administrator level 9.2.1 General Filter Settings General Filter QRS Trigger / DC Input / DC Output Function Freeze On Show Start Recording Dialogue Emergency ECG Resting ECG Exercise ECG ECG View Myogram On / Off - The Myogram filter reduces muscle induced noise.
  • Page 57: Qrs /Trigger / Dc Input / Dc Output

    Unit Settings Service handbook CP300 Settings at Physician/Administrator level 9.2.2 QRS /Trigger / DC Input / DC Output Settings General Filter QRS Trigger / DC Input / DC Output Function Freeze On Show Start Recording Dialogue Emergency ECG Resting ECG...
  • Page 58: Function Freeze

    Unit Settings Settings at Physician/Administrator level 9.2.3 Function Freeze The freeze function is an easy way of saving screen settings so that when the screen Settings is next visited, the same display settings (e.g. lead order, print settings, etc.,) are set. General Filter When Freeze is enabled (select before the option), an extra freeze icon appears in the QRS Trigger / DC Input / DC Output...
  • Page 59: Ecg Settings Filter And Lead Order

    Unit Settings Service handbook CP300 Settings at Physician/Administrator level 9.2.5 ECG Settings Filter and Lead Order Note that all of these settings are also available in the settings menu of the recording screens. Settings General Filter QRS Trigger / DC Input / DC Output...
  • Page 60: Ecg Settings Printer And Printout Settings

    Unit Settings Settings at Physician/Administrator level 9.2.6 ECG Settings Printer and Printout settings A printout can be obtained on the internal, or an external printer, directly after an auto Settings recording has been made. General Filter QRS Trigger / DC Input / DC Output Function Freeze On The format of the printout for both the internal and external printer is defined by the Show Start Recording Dialogue...
  • Page 61: Exercise Ecg Settings

    Unit Settings Service handbook CP300 Settings at Physician/Administrator level 9.2.7 Exercise ECG Settings Note that all of these settings are also available in the settings menu of the recording screens. Settings General Filter QRS Trigger / DC Input / DC Output...
  • Page 62: View

    Exercise ECG ECG View Select the setting of the load to maximum, or interpolate the load to that of the last and second to last load stages. An explanation of interpolation is given in the CP300 user guide. Page 62...
  • Page 63: Defining A Protocol

    Unit Settings Service handbook CP300 Settings at Physician/Administrator level 9.2.9 Defining a Protocol Select the protocol option from the Exercise ECG menu. All of the defined protocols are listed. To define a new protocol click the Add icon (1). To view a previously defined protocol, highlight it in the list and click the Settings icon (2).
  • Page 64 Unit Settings Settings at Physician/Administrator level Exercise Phase Ramp - A ramp protocol means that the load increase is applied gradually over the duration of the test at a rate of x Watts per minute. When this option is selected, the start load and the load increase per minute must be entered.
  • Page 65: 10 Maintenance

    The casing of the CP300 can be cleaned with a soft damp cloth on the surface only. Where necessary a domestic non-caustic cleaner can be used for grease and finger marks.
  • Page 66: Trouble Shooting

     Ensure that fresh CP300 paper is installed. • Old paper inserted. not clear, or the  Note that the thermal paper used for the CP300 is heat and light printout is sensitive. If it is not stored in its original seal, stored in high temper- ‘patchy‘.
  • Page 67: Master Reset

    Maintenance Service handbook CP300 Master Reset 10.3 Fault Possible Causes and indicators Remedies and Fault Location Patient recordings  Connection to network lost, check network. • No connection with SEMA data- shown base  In system settings Settings > system > database (administrator...
  • Page 68: Changing The Mains Fuse

    Maintenance 10.4 Changing the Mains Fuse 10.4 Changing the Mains Fuse  Before the fuse and mains voltage are changed, the device must be disconnected from the mains and the mains plug removed for the wall socket.  The fuse may only be replaced by the fuse type the table below. 10.4.1 Fuse Types Voltage range...
  • Page 69: 11 Technical Data

    Technical Data Service handbook CP300 System 11.1 11 Technical Data 11.1 System Dimensions 100 x 285 x 350 mm, (0.328 x 0.935 x 1.148 feet) 6.8 kg (14.99 lbs) Monitor • Backlit for graphic and LCD alphanumeric representation • 15" TFT- display, high-resolution 1024 x 768 pixels...
  • Page 70: Ecg

    Technical Data 11.2 11.2 Patient input Fully floating and isolated, defibrillation-protected (only with original patient cable) Leads • 12 simultaneous leads • Standard • Cabrera Monitor display Leads • 3 - 12 channel display of the selected leads – selectable speed of 5, 10, 20 mm/s –...
  • Page 71: Safety Standards

    Technical Data Service handbook CP300 Safety Standards 11.3 11.3 Safety Standards Safety standard • IEC/EN 60601-1 • IEC/EN 60601-2-25 • UL 2601-1 (2 Edition) • CSA22.2 No. 0-M91 • CSA22.2 No. 601.1 M90 • CSA22.2 No. 601.1 S1-94 • CSA22.2 No. 601.1 •...
  • Page 72: Emc Information

    Technical Data 11.4 EMC Information 11.4 EMC Information The unit meets the Collateral Standards of Electromagnetic compatibility – Require- ments and tests IEC/EN 60601-1-2 the limits and methods of measurement of elec- tromagnetic disturbance characteristics of industrial, scientific and medical radio fre- quency equipment.
  • Page 73: Emissions Equipment And Systems - Table 204

    Technical Data Service handbook CP300 EMC Information 11.4 11.4.3 Emissions Equipment and Systems - Table 204 Emissions Equipment and Systems that are NOT Life-Supporting Immunity Test IEC 606101 Test Level Compliance Level Electromagnetic environment guidance Portable and mobile communications equipment...
  • Page 74: Recommended Separation Distances - Table 206

    Technical Data 11.4 EMC Information 11.4.4 Recommended Separation Distances - Table 206 Recommended Separation Distance between Portable and Mo- bile RF Communications Equipment and the Device The user of the device can help prevent electromagnetic interference by maintaining a mini- mum distance between portable and mobile RF communications equipment (transmitter) and this device as recommended below, according to the maximum output power of the communi- cation equipment...
  • Page 75: 12 Construction Drawings

    Construction Drawings Service handbook CP300 Upper Assembly 12.1 12 Construction Drawings Conversion from drawing number to Welch Allyn PN refer to DIR30034004. 12.1 Upper Assembly Isolation Shield Deckel 4.415 542 16 x ZK M2.5x4 2 x PT22x8 4.910 200 4.910 227...
  • Page 76: Lcd Assembly

    Construction Drawings 12.2 LCD Assembly 12.2 LCD Assembly LCD back LCD-Klappe hinten 4.310 228 4 x PT25x8 4.910 211 LCD shield LCD-Abschirmung 4.416 154 4 x PT25x8 4.910 211 Inverter LCD support left LCD-Halter links 4.150 062 4.415 673 LCD AUO 4 x M2.5x12 4.600 092 4.910 017...
  • Page 77: Lower Casing

    Construction Drawings Service handbook CP300 Lower Casing 12.3 12.3 Lower Casing Page 77...
  • Page 78: Interconnections

    Construction Drawings 12.4 Interconnections 12.4 Interconnections Page 78...
  • Page 79: Isolation Diagram

    Construction Drawings Service handbook CP300 Isolation Diagram 12.5 12.5 Isolation Diagram Page 79...
  • Page 80: Emc Concept

    Construction Drawings 12.6 EMC Concept 12.6 EMC Concept Page 80...
  • Page 81: 13 Checklist

    CP300 checklist table 13.1 13 Checklist The following procedural checklist must be carried out by authorized Welch Allyn trained personnel. The recommended interval is that the unit is checked every 12 months.  It is a requirement of EN 60601 that the unit undergoes a safety test at defined intervals (see page 37), and a complete functional check at least every 24 months (detailed in the following checklist).
  • Page 82 Checklist 13.1 CP300 checklist table Reference False Remarks 6.3.5 LCD Screen Test (page 31) No spots or black fields on the screen. LCD shade (contrast and brilliance) is even all over. 6.3.6 Printer Checks (page 32) No fading Alignment OK...
  • Page 83 Checklist Service handbook CP300 CP300 checklist table 13.1 Reference False Remarks 6.4 I / O Port Checks (page 37) 1. Com 2 port I/O ok - both green lights lit 2. Com 4 port I/O ok - both green lights lit Ext 1, 2 and 3 ok - both green lights lit for all ports 6.5 Safety tests (page 39)
  • Page 84 Checklist 13.1 CP300 checklist table Other remarks Page 84...

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