Welch Allyn CP 150 12 Manual
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Welch Allyn CP 150 12 Manual

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CP 150 12-lead resting
electrocardiograph
Directions for use

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Summary of Contents for Welch Allyn CP 150 12

  • Page 1 CP 150 12-lead resting electrocardiograph Directions for use...
  • Page 2 Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician. Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual.

  • Page 3: Table Of Contents

    Contents Introduction ..................... 1 About this document ................... 1 Intended use ......................1 Indications for use ....................1 Contraindications ....................1 Description ......................2 Features ....................... 2 Controls, indicators, and connectors ..............3 Symbols ....................... 5 General warnings ....................7 General cautions ....................
  • Page 4 Contents CP 150 12-lead resting electrocardiograph Replacing the AC fuses ..................35 Storing the equipment ..................36 Discarding the equipment .................. 36 Troubleshooting ..................37 Lead-quality problems ..................37 System problems ....................40 Limited warranty ....................42 Service policy ..................... 43 EMC guidance and manufacturer’s declarations ........

  • Page 5: Introduction

    Intended use The Welch Allyn electrocardiography products (subject devices) are intended for use by trained operators in health facilities. The subject devices provide the following diagnostic functions: •...

  • Page 6: Description

    2 Introduction CP 150 12-lead resting electrocardiograph Description • The electrocardiograph allows users to perform 12-lead ECG measurements and analysis. • The electrocardiograph supports STAT, Auto, and Rhythm test types. • The electrocardiograph provides the ability to print test records on an internal printer or external network printer.

  • Page 7: Controls, Indicators, And Connectors

    Directions for use Introduction 3 Controls, indicators, and connectors No. Feature Description LCD screen 800 x 480 pixels color touchscreen provides a graphical user interface. Power switch and LED Power-on/Standby switch. The LED indicates the charging status when connected to AC power: •...
  • Page 8 4 Introduction CP 150 12-lead resting electrocardiograph Back view No. Feature Description Ethernet connector Provides a hardwired connection to the computer network. The LEDs indicate active network status when the ethernet cable is connected to a network. Clients USB USB, type "mini B." Provides connection to an enabled host.

  • Page 9: Symbols

    Directions for use Introduction 5 Symbols Documentation symbols WARNING The warning statements in Caution The caution statements in this this manual identify conditions or manual identify conditions or practices practices that could lead to illness, injury, that could result in damage to the or death.
  • Page 10 6 Introduction CP 150 12-lead resting electrocardiograph Connectivity symbols Ethernet (RJ-45 ) Shipping, storing, and environment symbols This end up Keep dry Fragile Relative humidity limit Temperature limits Atmospheric air-pressure limits Recycle Separate the battery from other disposables for recycling...

  • Page 11: General Warnings

    Visually inspect the battery at least monthly, if the battery shows any signs of damage or cracking, it must be replaced immediately and only with a battery approved by Welch Allyn. WARNING Improper disposal of batteries may create an explosion or contamination hazard.
  • Page 12 WARNING To provide CF protection use only accessories approved by Welch Allyn. Visit www.welchallyn.com. The use of any other accessories can result in inaccurate patient data, can damage the equipment, and can void your product warranty.

  • Page 13: General Cautions

    CAUTION Use only parts and accessories, including thermal paper, that were supplied with the device and available through Welch Allyn. The use of accessories other than those specified may result in degraded performance or unsafe use of this device.
  • Page 14 10 Introduction CP 150 12-lead resting electrocardiograph CAUTION The requirements of AAMI EC11, Section 3.2.7.2, Frequency and Impulse Response, for an impulse triangle waveform may be impacted by up to 5 milliseconds of small amplitude dampened ringing immediately after the impulse when the muscle filter (35 Hz) is turned on or a small amplitude offset when the baseline filter (0.5 Hz) is turned on.

  • Page 15: Setup

    WARNING To provide CF protection use only accessories approved by Welch Allyn. Visit www.welchallyn.com. The use of any other accessories can result in inaccurate patient data, can damage the equipment, and can void your product warranty.

  • Page 16: Powering The Electrocardiograph

    12 Setup CP 150 12-lead resting electrocardiograph Powering the electrocardiograph The electrocardiograph runs on AC or battery power. Plug the electrocardiograph into AC power as often as possible so that the built-in charger can keep the battery charged. Regardless of the battery condition, you can use the electrocardiograph whenever it is plugged in.

  • Page 17: Connecting To A Cardioperfect Workstation

    • Z-fold thermal paper should stop with perforations near the tear bar, indicating proper cue-sensor operation. 3. If you see any indications of improper operation, contact Welch Allyn Technical Support. Connecting to a CardioPerfect workstation You can connect a electrocardiograph to a Welch Allyn CardioPerfect workstation via USB cable or via Ethernet cable.
  • Page 18 14 Setup CP 150 12-lead resting electrocardiograph 2. Go to the Network screen a. Touch the Settings tab. b. Touch the Device tab. c. Touch the Network button. 3. Fill in the screen. • If DHCP is enabled for the network, select the DHCP checkbox.

  • Page 19: Ecg Home Screen

    ECG home screen ECG home screen The ECG home screen includes the following areas: Item Area Device status Content Navigation Device status area The Device status area, located at the top of the ECG home screen, displays: • Time and date •...
  • Page 20 16 ECG home screen CP 150 12-lead resting electrocardiograph Content area The Content area includes 3 test selection buttons and a preview selection button: • Auto ECG • Rhythm ECG • Stat ECG • Electrode Placement The content area also provides shortcuts to several controls.
  • Page 21 Directions for use ECG home screen 17 Example ECG report...
  • Page 22 18 ECG home screen CP 150 12-lead resting electrocardiograph...

  • Page 23: Ecg Tests

    ECG tests Attaching the leads to the patient Proper lead attachment is important for a successful ECG. The most common ECG problems are caused by poor electrode contact and loose leads. Follow your local procedures for attaching the leads to the patient. Here are some common guidelines. WARNING Electrodes can cause allergic reactions.
  • Page 24 20 ECG tests CP 150 12-lead resting electrocardiograph Electrode examples, left to right: arm clamp (reusable), Welsh cup (reusable), tab electrode (disposable), monitoring electrode (disposable). • For reusable electrodes: Use electrode paste, gel, or cream to cover an area the size of each electrode but no larger. Secure the arm and leg clamps. Apply the Welsh cups (suction electrodes) to the chest.

  • Page 25: Electrode Locations

    Directions for use ECG tests 21 Electrode locations Location V1 (red) C1 (red) Fourth intercostal space at the right sternal border. V2 (yellow) C2 (yellow) Fourth intercostal space at the left sternal border. V3 (green) C3 (green) Midway between V2 and V4. V4 (blue) C4 (brown) Fifth intercostal space to the left of the midclavicular line.

  • Page 26: Viewing Electrode Placement

    22 ECG tests CP 150 12-lead resting electrocardiograph Viewing electrode placement 1. Touch the (ECG preview) button. The ECG preview screen appears. 2. Touch the (torso) button to enlarge the lead placement image or touch to close it. Performing an Auto ECG test CAUTION Patient data is not saved until the ECG test is completed.
  • Page 27 Directions for use ECG tests 23 • Patient ID. Touch the OK button. • Birth date. Touch the OK button. • Last name. Touch the OK button. • First name. Touch the OK button. • Middle Initial. Touch the OK button. If the patient has a pacemaker touch the Pacemaker present Note button.
  • Page 28 24 ECG tests CP 150 12-lead resting electrocardiograph Item Button Leads button Gain button (size) Speed button Filters button 8. If an Artifact message appears, minimize the artifact, as described under Troubleshooting. You might need to ensure that the patient is comfortably warm, reprepare the patient’s skin, use fresh electrodes, or minimize patient motion.
  • Page 29 Directions for use ECG tests 25 • Remote file location 13. Touch Reprint to print the test again, touch Retest to discard the test and start over, or touch Exit. WARNING To avoid the risk of associating reports with the wrong patients, make sure that each test identifies the patient.
  • Page 30 26 ECG tests CP 150 12-lead resting electrocardiograph...

  • Page 31: Saved Tests

    Edit the patient data in Saved Tests. • Send saved tests to a USB mass-storage device or to a Welch Allyn CardioPerfect workstation. (Any tests that you send to a USB mass-storage device can be retrieved only from a CardioPerfect workstation.) To manage saved tests 1.
  • Page 32 28 Saved tests CP 150 12-lead resting electrocardiograph...

  • Page 33: Settings

    Settings Viewing or changing the ECG settings • The ECG settings control the content and format of your reports. These settings include a second Auto report format (Auto report) and a Rhythm format (Rhythm report), customizable patient data fields, and auto save options. To view or change the settings 1.

  • Page 34: Selecting The Device Information

    30 Settings CP 150 12-lead resting electrocardiograph • Rhythm leads 1 - 12 Touch the Auto report tab. Modify the settings as desired: • Printer • Report format • Average cycles • Rhythm leads 1 - 3 Touch the (Next) button.
  • Page 35 Directions for use Settings 31 • Language Touch the Device configuration tab. Modify the settings as desired: • Auto save • Data management • LCD brightness • HR beep on • Error beep on • Caps lock on or off •...
  • Page 36 32 Settings CP 150 12-lead resting electrocardiograph...

  • Page 37: Maintenance

    Maintenance Cleaning the equipment WARNING Keep the electrocardiograph, reusable electrodes, and the patient cable clean. Patient contact with contaminated equipment can spread infection. CAUTION Never let soap or water come into contact with the electrocardiograph’s internal printer, connectors, or jacks. CAUTION Never immerse the electrocardiograph or the patient cable in liquid.

  • Page 38: Inspecting The Equipment

    Check all cable and cord connections; reseat if any connectors are loose. Testing the electrocardiograph Welch Allyn recommends verifying proper operation of the electrocardiograph once a year to ensure reliability. See Verifying proper operation. Whenever the electrocardiograph is serviced or whenever problems are suspected, verify continued electrical safety of the device using IEC 60601-1 or ANSI/AAMI ES1 methods and limits.

  • Page 39: Replacing The Battery

    Directions for use Maintenance 35 • Chassis leakage current • Earth leakage current • Dielectric strength (AC and patient circuits) Replacing the battery Replace the battery under these circumstances: • It loses its charge quickly. • You have charged it, and the electrocardiograph still does not turn on when unplugged.

  • Page 40: Storing The Equipment

    Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at +44 207 365 6780.

  • Page 41: Troubleshooting

    Troubleshooting Lead-quality problems “Artifact” message on the screen Artifact is signal distortion that makes it difficult to accurately discern the waveform morphology. Causes • The patient was moving. • The patient was shivering. • There is electrical interference. Actions See actions for wandering baseline, muscle tremor, and AC interference. Wandering baseline Wandering baseline is an upward and downward fluctuation of the waveforms.
  • Page 42 38 Troubleshooting CP 150 12-lead resting electrocardiograph Muscle tremor Causes • The patient is uncomfortable, tense, nervous. • The patient is cold and shivering. • The exam bed is too narrow or short to comfortably support arms and legs. •...
  • Page 43 Directions for use Troubleshooting 39 Lead alert or square wave A dot might be flashing on the lead-status screen. Or one or more leads might appear as a square wave. Causes • Electrode contact might be poor. • A lead might be loose. •...

  • Page 44: System Problems

    40 Troubleshooting CP 150 12-lead resting electrocardiograph System problems The electrocardiograph won't turn on when it is plugged in Causes • The AC power connection is faulty. • An AC fuse is blown. • There is no AC power. Actions •...
  • Page 45 Directions for use Troubleshooting 41 The electrocardiograph does not respond when you press buttons or touch the screen Causes • The electrocardiograph is frozen. Actions • Reset the electrocardiograph by pressing and holding the power button for at least six seconds until the screen goes blank. Press the power button again. The electrocardiograph goes through some diagnostic tests that cause it to take longer than usual to power up.

  • Page 46: Limited Warranty

    CP 150 12-lead resting electrocardiograph Limited warranty Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for the period of three years from the date of purchase from Welch Allyn or its authorized distributors or agents.

  • Page 47: Service Policy

    Troubleshooting 43 Service policy All repairs on products under warranty must be performed by Welch Allyn or by a service provider authorized by Welch Allyn. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair should be performed exclusively by Welch Allyn or by a service provider that has been authorized by Welch Allyn.
  • Page 48 44 Troubleshooting CP 150 12-lead resting electrocardiograph...

  • Page 49: Emc Guidance And Manufacturer's Declarations

    This device complies with IEC EN 60601-1-2:2007. • All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this document and the Welch Allyn CP 150 12- lead resting electrocardiograph Directions for Use. •...

  • Page 50: Electromagnetic Immunity

    46 EMC guidance and manufacturer’s declarations CP 150 12-lead resting electrocardiograph Emissions test Compliance Electromagnetic environment - guidance IEC 61000-3-2 Complies Voltage fluctuations/ flicker emissions IEC 61000-3-3 Electromagnetic immunity The CP 150 electrocardiograph is intended for use in the electromagnetic environment specified below.

  • Page 51: Electromagnetic Immunity

    Directions for use EMC guidance and manufacturer’s declarations 47 Electromagnetic immunity The CP 150 electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or user of the CP 150 electrocardiograph should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...

  • Page 52: Recommended Separation Distances Between Portable And Mobile Rf

    48 EMC guidance and manufacturer’s declarations CP 150 12-lead resting electrocardiograph Recommended separation distances between portable and mobile RF communications equipment and the CP 150 electrocardiograph The CP 150 electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the CP 150...

  • Page 53: Specifications

    Specifications Item Specification 380.9 mm x 358.1 mm x 136.2 mm (15 x 14.1 x 5.4 in.) Dimensions, including rubber feet (length x width x height) Weight , including battery 5.2 kg (11.5 lb) Keyboard type (power button) Polyester overlay Display Type TFT, 18 cm (7 in.) color touch screen...
  • Page 54 50 Specifications CP 150 12-lead resting electrocardiograph Item Specification 6x2-5.0s @ 25 mm/s 6x2-5.0s @ 50 mm/s 12x1-10.0s @ 25 mm/s Report formats, internal printer, 3x4+3R @ 25 mm/s Average 3x4+3R @ 50 mm/s 6x2+1R @ 25 mm/s 6x2+1R @ 50 mm/s...
  • Page 55 Accuracy of input signal reproduction, the manufacturer shall disclose the methods used to establish overall system error and frequency response. Welch Allyn has used methods A & D, as prescribed in section 3.2.7.2 and 4.2.7.2 of this same standard, to verify overall system error and frequency response.
  • Page 56 52 Specifications CP 150 12-lead resting electrocardiograph *** Disposable electrodes from Welch Allyn shall be used during patient defibrillation. Specifications are subject to change without notice.
  • Page 58 Reorder No. 105313 Material No. 720134...

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