Burdick 8300 and 8500 ECG Service Manual Rev B

This document contains instructions for both the Burdick 8300 and Burdick 8500. Information in this document is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted. CE Mark Declaration The CE marking of conformity indicates that the device having this symbol on its immediate label meets the applicable requirements of the European Medical Device Directive. Trademark Information Cardiac Science, the Shielded Heart logo, Quinton, Burdick, and HeartCentrix are trademarks or registered trademarks of Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies. Copyright © 2011Cardiac Science Corporation. All Rights Reserved. TO RESPONSIBLE SERVICE PERSONNEL: The contents of this document are not binding. If any significant differences between the product and this document are encountered regarding service work, contact Cardiac Science Corporation for more information. Cardiac Science Corporation recommends the use of authorized Cardiac Science Corporation personnel for the maintenance and repair of all Burdick equipment. Cardiac Science cannot warrant the operation of the equipment if other than Burdick genuine replacement or exchange parts are used in the service or repair of this equipment, and if such service or repair is performed by non-authorized personnel. This product has been carefully designed to provide a high degree of safety and dependability. However, we can not guarantee against the deterioration of components due to aging and normal wear.

Cardiac Science Corporation 3303 Monte Villa Parkway Bothell, WA 98021, USA 800.426.0337 (USA) 425.402.2000 [email protected] www.cardiacscience.com ii

70-00844-02 B

EC REP

MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany Burdick 8300/8500

Contents

Contents Chapter 1: General Information About the Burdick electrocardiographs ... 1-1 System description ... 1-2

Chapter 2: Service & Maintenance When to perform service procedures ... 2-2 Functional checkout ... 2-3 Required equipment... 2-3 Functional checkout procedure ... 2-3 Calibration pulse check procedure... 2-5 Electrical leakage current tests ... 2-6 Required equipment... 2-6 Patient leakage current procedure ... 2-6 Patient sink current procedure... 2-7 Queue sensor calibration... 2-8 Calibration procedure... 2-8

Chapter 3: Troubleshooting Preliminary checks ... 3-2 Troubleshooting chart... 3-3

Chapter 4: Component Replacement Parts list ... 4-2 Component replacement... 4-7 Replace the top cover assembly... 4-7 Replace the paper drive assembly ... 4-8 Replace the ECG device mainboard ... 4-9 Replace the power supply board ... 4-10 Replace the external power supply ... 4-11 Disassembly ... 4-12 Remove the battery pack ... 4-12 Remove the keyboard assembly ... 4-14 Remove the ECG device top cover assembly... 4-15 Remove the paper drive assembly ... 4-16 Remove ECG device 8300 mainboard assembly ... 4-17 70-00844-02 B

Contents

iii

Contents

Remove ECG device 8500 mainboard assembly ... 4-18 Remove power supply board... 4-20 Remove the paper door... 4-21

iv

Contents

70-00844-02 B

1

General Information Contents ◆

About the Burdick electrocardiographs

1-1

◆

System description

1-2

For a complete list of warnings and cautions see the Burdick 8300 and Burdick 8500 Product Information and Safety manual.

! ! !

DANGER! Explosion hazard Do not use this device in the presence of flammable anesthetics.

Caution: Restricted device Federal law restricts the sale, distribution, or use of this device to, by, or on the lawful order of a health professional. Caution: Possible data corruption Some procedures require you to access the Service Functions menu. The Service Functions menu is intended for qualified Service personnel. If you have any question, please contact Technical Support.

About the Burdick electrocardiographs The Burdick electrocardiograph is a multichannel electrocardiograph with a thermal printer. The device includes ECG interpretation and network connectivity.

Burdick 8300/8500

70-00844-02 B

1-1

General Information

System description The Burdick ECG device has the following main subsystems:

1-2

1.

Mainboard contains the host and front end.

2.

Power Supply Board: Receives input power from the external power supply or battery pack, supplies power to the ECG device, and recharges the battery pack when connected to external power.

3.

Paper Drive Assembly: Includes the printhead, queue sensor to correctly position the paper, and the paper drive motor to feed the paper.

4.

The Top Cover Assembly: Contains the keyboard and video display.

70-00844-02 B

Burdick 8300/8500

2

Service & Maintenance Contents ◆

When to perform service procedures

2-2

◆

Functional checkout

2-3

◆

Electrical leakage current tests

2-6

◆

Queue sensor calibration

2-8

Burdick 8300/8500

70-00844-02 B

2-1

Service & Maintenance

When to perform service procedures Perform the following procedures as indicated: 1.

Functional checkout on page 2-3: Used to verify normal operation. Must be performed before returning the ECG device to the user.

2.

Electrical leakage current tests on page 2-6: Used to verify ECG device electrical safety. Must be performed after any internal repair (i.e., the case is opened), or to check for possible damage (e.g., the ECG device is dropped).

3.

Queue sensor calibration on page 2-8: Used to ensure paper feeds correctly. Must be performed if: a. The paper tray assembly is removed or replaced b. The queue sensor board is replaced c. The power supply board is replaced d. The mainboard is replaced.

2-2

70-00844-02 B

Burdick 8300/8500

Functional checkout

Functional checkout Use this procedure to verify normal operation before returning the ECG device to the user.

Required equipment ◆

Patient Simulator

Functional checkout procedure If necessary, turn off the ECG device and disconnect the AC power cord. 1.

Plug the AC power cord into a wall outlet. Wait until Press On/Standby to power on the unit displays on the Battery Charging screen.

2.

Press the On/Standby key to power on the ECG device. Verify the ECG device boots up to the Home screen without errors.

3.

Remove any paper, if installed, and note the printhead resistance in the battery compartment.

4.

Press Setup.

5.

Use the arrow keys (Next and Previous) to scroll to Service Functions and press Select twice.

6.

Scroll to Printhead Resistance and verify the resistance matches the printhead resistance label in the battery compartment. Note: If the mainboard is replaced, the printhead resistance must be re-entered.

If the paper tray assembly is replaced, a new printhead resistance must be entered and the label in the battery compartment must be changed (both should match the printhead resistance written on the printhead). 7.

Reinstall the paper and verify the paper type. a. Press Setup. b. Select System | Paper Type.

8.

Press Setup scroll to Service Functions and press Select twice.

9.

Scroll to Printer Test Sequence. The ECG device prints 3 pages of test characters. Verify all characters print evenly across the page. Note: The test characters may appear lighter or darker, depending on the type of paper used, but the printing should still be clear and even across the page.

10. Press the Home key. 11. Turn on the patient simulator. 12. Connect the patient simulator to the ECG device. Burdick 8300/8500

70-00844-02 B

2-3

Service & Maintenance

On the Home screen, verify: •

The patient name and ID number or No Name, (No Id) display

Note: The patient name and ID number display when patient demographic information has already been entered. •

The SENSORS OK message displays.

•

AC displays

13. Disconnect the AC power cord for 1 minute and verify the ECG device continues to

operate normally (AC will change to BAT). Note: If the ECG device shuts down immediately after disconnecting the AC power, ensure the battery is installed and securely connected. 14. Reconnect the power cord and verify BAT changes back to AC. 15. Press the ECG key to acquire and print out an Auto ECG.

The printout will consist of a 12 lead formatted ECG. Verify the following: a. Correct printing of the lead waveforms. b. Stat ID number entered in the ID field. c. Correct date and time when the ECG was acquired. d. Interpretation indicates Normal ECG. 16. Press the Home key. 17. Press the Directory key to verify the ECG is saved in the patient directory. 18. Press the Home key. 19. Disconnect the patient simulator.

2-4

70-00844-02 B

Burdick 8300/8500

Functional checkout

Calibration pulse check procedure Cardiac Science recommends performing a calibration pulse (cal pulse) check procedure annually to test the sensitivity of the system. To perform the cal pulse check, apply a cal pulse individually to Leads I, II, and V1-V6 (C1-C6) and verify they reproduce a 1 mV within a tolerance of ±5% of the input signal. You can perform a cal pulse check using a commercial ECG simulator (described here) or you can use a test circuit as described in IEC 60601-2-51 (2005)

Commercial ECG simulator method The ECG simulator must have a 1 mV (±0.01 mV) cal pulse with rise time of not greater than 5 ms. 1.

Consult the user manual for the ECG simulator to determine the correct way to hook the simulator to the ECG recorder and to perform a cal pulse test.

2.

Measure the output of each lead to be tested by connecting the patient electrode wire to the input of the appropriate cal pulse connector while all other patient electrode wires are connected to their appropriate connection points.

3.

Follow the instructions for the ECG simulator to verify that the resultant cal pulse amplitude for each lead is reproduced with no more than ±5% error.

Burdick 8300/8500

70-00844-02 B

2-5

Service & Maintenance

Electrical leakage current tests Use these tests to verify ECG device electrical safety. All leakage tests must be performed after any internal repair (i.e., the case is opened), or to check for possible damage (e.g., the ECG device is dropped). The ECG device is Class II (ungrounded equipment). The exposed metal on the ECG device is not likely to become energized by internal live circuitry. (All exposed metal is double insulated from the internal live circuitry and does not become energized even under single fault conditions.) Therefore it is safer not to connect the exposed metal to the internal chassis or to the functional earth of the ECG device. This method of protection is recognized by all national and international consensus standards and safety agencies. The exposed metal in the ECG device cannot become energized by internal live circuitry nor by differences in the ground potential, so there is no reason to provide voltage equalization.Use the equipotential ground contact (ground lug) to interconnect the chassis and functional earth of the ECG device, via the equipotential ground system, to other electrical noise sources in a room. This reduces electrical noise that might appear on the output of the ECG.

Required equipment 1.

Dynatech Nevada 235A Safety Analyzer

Note: The Dynatech Safety Analyzer is recommended for this procedure, if a different safety analyzer is used, consult the user manual for proper setup and testing procedures.

Patient leakage current procedure Note: Ensure that the Kelvin cable is not connected. 1.

Plug the safety analyzer into the 264 VAC line voltage.

2.

Plug the ECG device power cable into the test receptacle on top of the safety analyzer.

3.

Connect a patient cable between patient input connector on the ECG device and the appropriate patient terminals on the top of the safety analyzer.

4.

Press the Enable button for the ECG leads group on the safety analyzer.

5.

Turn the Select knob to select All.

6.

Verify the leakage current is less than 10 μA for these conditions: a. Polarity Normal, ECG device power on b. Polarity Normal, Open Ground, ECG device power on c. Polarity Normal, Open Neutral, ECG device power on d. Polarity Reversed, ECG device power on e. Polarity Reversed, Open Ground, ECG device power on f. Polarity Reversed, Open Neutral, ECG device power on

2-6

70-00844-02 B

Burdick 8300/8500

Electrical leakage current tests

Patient sink current procedure

!

WARNING! Shock hazard. This test applies AC Line Voltage to the patient cable. Note: Ensure that the Kelvin cable is not connected. 1.

Turn the Select knob to select Isolation in the ECG leads group and wait for the numbers to display.

2.

Press the ISO test button and verify that the highest measured value is less than 50 μA.

Burdick 8300/8500

70-00844-02 B

2-7

Service & Maintenance

Queue sensor calibration Use queue sensor calibration to measure and record queue sensor voltages based on queue sensor characteristics and internal physical alignment. Required when: ◆

The paper tray assembly is removed or replaced

◆

The queue sensor board is replaced

◆

The power supply board is replaced

◆

The mainboard is replaced

If this calibration fails twice, contact Technical Support. Note: This procedure is not required if the paper door is replaced or after minor adjustments.

Calibration procedure

!

Caution: Equipment damage Use only Assurance® or Heartline™ standard paper. Using any other paper may damage the ECG device and void the warranty. 1.

Insert paper into the paper drive so that the print head is approximately half-way between the perforations of the paper.

2.

Power on the ECG device and verify the ECG screen displays (press the Home key.)

3.

Press Setup.

4.

Use the arrow keys (Next and Previous) to scroll to Service Functions and then press Select. The system displays a warning regarding assessing the service functions.

5.

Press Select.

6.

Scroll to Queue sensor calibration and press Select.

7.

Press Select to start the calibration. The DAC value should be approximately 100.

8.

Press Home.

9.

Press the Form Feed key and verify the paper queues correctly.

10. Select Setup | Waveform Preferences | Speed | 12.5mm/s.

2-8

70-00844-02 B

Burdick 8300/8500

Queue sensor calibration

11. Press the Manual Rhythm key and print 3 pages of ECG data.

Verify additional headers are not printed on the pages. 12. Press Stop.

Verify the paper queues correctly. 13. Select Auto Rhythm.

Verify a one page report prints and the paper correctly queues. 14. Repeat for waveform speeds of 25 mm/s and 50 mm/s.

Burdick 8300/8500

70-00844-02 B

2-9

Service & Maintenance

2-10

70-00844-02 B

Burdick 8300/8500

3

Troubleshooting Contents ◆

Preliminary checks

3-2

◆

Troubleshooting chart

3-3

Burdick 8300/8500

70-00844-02 B

3-1

Troubleshooting

Preliminary checks Before using the troubleshooting chart below, check the following: 1.

Ensure users are correctly following instructions listed in the User’s Guide. Verify proper skin preparation, lead placement, lead integrity, etc.

2.

Check the ECG device settings (Setup | Print Setup Report) to ensure the ECG device is configured as expected.

3.

Verify external cables are undamaged and securely connected. Swap out the power cable, external transformer, and patient cable with known good cables.

4.

3-2

Check for any other visible damage such as cracks in the case, broken or cracked cable connectors, or rattling when the ECG device is moved.

70-00844-02 B

Burdick 8300/8500

Troubleshooting chart

Troubleshooting chart Table 3-1: Troubleshooting chart

Problem

Solution Check the following for general problems (refer to the Operating Instructions Troubleshooting section for specific problems and solutions).: 1. Try to prevent unnecessary patient movement.

Artifacts or noise on ECG trace

2. Ensure all leads are clean, secure, and properly placed. 3. Ensure the skin is properly prepared and unbroken. 4. Ensure all cables are securely connected. 5. Check cables for damage, including nicks, cuts, wear, or bulging. 6. Position the ECG device as far from other electronic equipment as

possible. This message is normally displayed for about 15 seconds after beginning an ECG acquisition. If it does not go away after about 15 seconds: Message Waiting for Data is displayed

1. Check the screen for a lead fail indication, and then fix that lead. 2. Check all the ECG leads. 3. Troubleshoot for noise (see Artifacts or noise on ECG trace). 4. Refer to the Operating Instructions for additional troubleshooting

information. 1. Ensure both ends of the power cord are securely connected. 2. Ensure green LED on external power supply is on. 3. Disconnect the ECG device from the external power supply and

AC power indicator is off (Green LED on back panel)

see if the external power supply LED is on. 4. Ensure the power outlet is working. 5. Replace power cord. 6. Replace the external power supply. This solution must be performed by qualified service personnel: 1. Replace power supply board.

Burdick 8300/8500

70-00844-02 B

3-3

Troubleshooting

Table 3-1: Troubleshooting chart (continued) (continued)

Problem

Solution The ECG device will shut off if both AC and battery power are interrupted at the same time. The ECG device must have a battery installed during normal operation. 1. If operating from the battery, ensure the battery is charged and

the cable securely connected. 2. If operating from AC power, ensure the battery is installed and AC

ECG device unexpectedly reboots (crashes)

power is available 3. After a crash, insert a USB flash drive and select Setup. 4. Use the arrow keys (Next and Previous) to scroll to

Service Functions and then press Select twice. 5. Scroll to Copy crash dump to USB and press Select. The ECG device writes a text file that can be sent to Technical Support for analysis. Video Display 1. No display 2. Display is too dark or too light 3. Display is unstable

1. Ensure a battery is installed and check the green power LED on the

back panel to verify AC power is available. 2. Try adjusting the brightness (Shift + Next or

Shift + Previous). 3. Press and hold the On/Standby key for 8 seconds to power off and then press On/Standby again to restart the ECG device. These solutions must be performed by qualified service personnel: Note: When opening this unit for troubleshooting, DO NOT unplug

the video cable from the logic board unless you are replacing the top assembly. The video cable is fragile. 1. Ensure keyboard cable is securely connected. 2. Ensure the display cable is securely connected. The graphic below

shows the Video Display cable improperly connected--the cable is not fully inserted into the jack and the right tab is not fully engaged to lock in the cable. 3. Replace the top cover assembly. 4. Replace the power supply board. 5. Replace the mainboard.

3-4

70-00844-02 B

Burdick 8300/8500