Welch Allyn CP 50 Directions For Use Manual
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Welch Allyn CP 50 Directions For Use Manual

12-lead resting electrocardiograph
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CP 50™ and CP 50 Plus™ 12-lead
resting electrocardiograph
Directions for use

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Summary of Contents for Welch Allyn CP 50

  • Page 1 CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Directions for use...
  • Page 2 Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, 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 statement of intended use published in this manual.

  • Page 3: Table Of Contents

    Managing the user list (optional - available with CP 50 Plus only) ..... 29 Turning the audit trail on or off (optional - available with CP 50 Plus only) ..30 Managing the worklist (optional - available with CP 50 Plus only) ..... 30 Managing the test directory ................
  • Page 4 Contents CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Replacing the AC fuses ..................36 Storing the equipment ..................36 Discarding the equipment .................. 36 Troubleshooting ..................37 Lead-quality problems ..................37 System problems ....................40 Limited warranty ....................41 Service policy .....................

  • 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: About The Test Types

    A report typically showing a 10-second acquisition of 12 leads of ECG information combined with patient data, measurements, and optional interpretation. Auto ECGs can be saved to the electrocardiograph’s test directory or to a USB mass-storage device. In CP 50 Plus models, auto ECGs can also be sent to a Welch Allyn CardioPerfect workstation.

  • Page 7: Features

    CAUTION Check for the presence of a pacemaker before using ECG with interpretation. CP 50 Plus (optional) The CP 50 Plus consists of the CP 50 device and an optional connectivity feature that is enabled with a software activation code.

  • Page 8: Configuration Options

    4 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Configuration options The device is available in multiple configurations. Use the following to identify a configuration: [Device][Feature]-[Cable][Language][PowerCord] Position Description Four characters that indicate the device: CP50. [Device] [Feature] One or two characters that indicates the added feature: •...

  • Page 9: Symbols

    Consult directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days. Operation symbols Power on/standby...
  • Page 10 6 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Power symbols (LED off) No AC power is present Battery absent or faulty (LED green) AC power is present, and Battery is charged to the indicated level battery is charging. (LED amber) AC power is present, and battery is charging.
  • Page 11 Directions for use Introduction 7 Recycle Separate the battery from other disposables for recycling China RoHS Separate the device from other disposables for recycling See www.welchallyn.com/weee. Miscellaneous symbols Heartbeats per minute Hot surface. Do not touch. Manufacturer Date of manufacture Defibrillation-proof Type CF applied part Serial number Product identifier...

  • Page 12: General Warnings

    8 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph General warnings Warnings indicate conditions or practices that could lead to illness, injury, or death. Warnings related to the environment WARNING To avoid a possible explosion, do not use the electrocardiograph in the presence of flammable anesthetics: mixtures containing air, oxygen, or nitrous oxide.
  • Page 13 WARNING 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, including compromised defibrillator protection, increased electromagnetic emissions or decreased electromagnetic immunity.

  • Page 14: General Cautions

    10 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph WARNING To avoid injury, do not touch the print head immediately after printing. It might be hot. WARNING No modification of this equipment is allowed. WARNING To provide CF protection use only accessories approved by Welch Allyn.
  • Page 15 Directions for use Introduction 11 CAUTION The power cord must be disconnected from AC power before cleaning, maintaining, transporting, or servicing. 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 16 12 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph...

  • Page 17: 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 18: Loading The Thermal Paper

    14 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Loading the thermal paper The electrocardiograph prints on z-fold thermal paper or roll thermal paper. • Store the paper in a cool, dry, dark place. • Do not expose it to bright light or UV sources.
  • Page 19 Directions for use Setup 15 To load a roll of thermal paper...

  • Page 20: Powering The Electrocardiograph

    16 Setup CP 50™ and CP 50 Plus™ 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.

  • Page 21: About The Menu

    Three setting types are available: • The ECG settings, which control the content and format of your reports. In CP 50 Plus models, these settings include a second report format (auto report 2), customizable patient data fields, and auto save options.

  • Page 22: Verifying Proper Operation

    The amplitude and rate of the waveforms should match the input value from the ECG simulator. • 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, call Welch Allyn Technical Support.

  • Page 23: Connecting To An External Usb Printer (Optional - Available With Cp 50 Plus Only)

    Connecting to an external USB printer (optional - available with CP 50 Plus only) You can connect a CP 50 Plus electrocardiograph to an external printer. The printer must be a USB inkjet or laser printer that supports PCL3 and PCL5 (printer control languages).
  • Page 24 20 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph To connect to a workstation via USB cable Connect the electrocardiograph to any of the workstation’s USB ports. No software configuration is required. The electrocardiograph is ready to communicate.
  • Page 25 Directions for use Setup 21 The electrocardiograph is ready to communicate with the workstation. (To set up the workstation, see the instructions that came with the workstation connectivity software.)
  • Page 26 22 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph...

  • Page 27: 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 28 24 ECG tests CP 50™ and CP 50 Plus™ 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.

  • Page 29: Electrode Locations

    Directions for use ECG tests 25 Electrode locations Location Fourth intercostal space at the right sternal border. (red) (red) Fourth intercostal space at the left sternal border. (yellow) (yellow) Midway between V2 and V4. (green) (green) Fifth intercostal space to the left of the midclavicular line. (blue) (brown) Anterior axillary line at the same horizontal level as V4.
  • Page 30 26 ECG tests CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Location Just above the right ankle. (green) (black) Just above the right wrist on the inside of the arm. (white) (red)

  • Page 31: Performing An Ecg Test

    Directions for use ECG tests 27 Performing an ECG test 1. Attach the leads to the patient. Any flashing dots on the lead-status screen indicate unattached or poorly attached leads. When all leads have been attached for several seconds, the ECG preview screen appears.
  • Page 32 (CardioPerfect workstation or EMR). • The Worklist button (CP 50 Plus only) gives you access to patient data in the worklist. 5. If a Waiting for 10 (or 20) seconds of quality data message appears, at least 10 or 20 seconds of ECG data have been collected with excessive artifact.

  • Page 33: Administrative Tasks

    2. Touch Settings > Security. 3. Turn the security option on or off. Managing the user list (optional - available with CP 50 Plus only) The user list, which is enabled when the security option is on, identifies all individuals who are authorized to access patient data.

  • Page 34: Turning The Audit Trail On Or Off (Optional - Available With Cp 50 Plus Only)

    1. Touch the menu button. 2. Touch Settings > System. 3. Turn the audit trail on or off. Managing the worklist (optional - available with CP 50 Plus only) The worklist is a group of patients whose demographic data has been entered into the electrocardiograph memory to be recalled for a test later that day.

  • Page 35: Managing The Test Directory

    When you perform an auto ECG, you can fill in the patient’s data from the test directory automatically by touching the search button. With all electrocardiograph models, you can delete or print saved tests. With CP 50 Plus models, you can also do the following: •...
  • Page 36 32 Administrative tasks CP 50™ and CP 50 Plus™ 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 Directions for use Maintenance 35 To replace the battery Remove the old battery Insert the new battery...

  • Page 40: Replacing The Ac Fuses

    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 50™ and CP 50 Plus™ 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 50™ and CP 50 Plus™ 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.

  • Page 45: Limited Warranty

    Product or accessory free of charge. If your Product requires repairs covered by this warranty, upon your request Welch Allyn will loan to you, at no cost, a substitute Product for use until your repaired Product is returned.

  • Page 46: Service Policy

    DEFECT COVERED BY THE WARRANTY. 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 47: Specifications

    Specifications Item Specification Dimensions, including 32.5 x 8 x 18.8 cm (12.8 x 3.1 x 7.4 in.) rubber feet (length x height x width) Weight 2.0 kg (4.4 lb) Keyboard type (power, Polyester overlay auto ECG, and rhythm ECG buttons) Display Type TFT, 11 cm (4.3 in.) color touch screen...
  • Page 48 CAN/CSA C22.2 No. 601.1.2 IEC/EN 60601-1-2 CAN/CSA C22.2 No. 601.1.4 IEC/EN 60601-1-4 CAN/CSA C22.2 No. 601.2.25 IEC/EN 60601-1-6 IEC/EN 60601-2-25 *** IEC/EN 60601-2-51 (2x6 lead arrangement) Standard connectivity Mini USB client and USB host, Ethernet (optional - available with CP 50 Plus only)
  • Page 49 Because of the sampling characteristics and the asynchronism between sample rate and signal rate, digital ECG systems such as the CP 50 may produce a noticeable modulating effect from one cycle to the next, particularly in pediatric recordings. This phenomenon is not physiologic.
  • Page 50 46 Specifications CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph...

  • Page 51: Guidance And Manufacturer's Declarations

    Emissions and immunity information Electromagnetic emissions The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph should assure that it is used in such an environment.

  • Page 52: Electromagnetic Emissions

    The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph should assure that it is used in such an environment.
  • Page 53 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is used exceeds the applicable RF compliance level above, the Welch AllynCP 50™ and CP 50 Plus™...
  • Page 54 Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Welch AllynCP 50™ and CP 50 Plus™...

  • Page 55: Accessory List

    ECG reusable limb clamps, IEC, 4 715992 ECG reusable limb clamps, AHA, 4 719653 10-lead ECG patient cable, AHA, banana (1M/39 inch), CP 50/150 719654 10-lead ECG patient cable, IEC, banana, CP 50/150 721328 10-lead ECG patient cable, AHA, banana (1.5M/5 feet), CP 50/150...
  • Page 56 52 Accessory list CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph ECG stand Part number Description 715107 Carrying case, CP50 Miscellaneous items Part number Description BATT33 Lithium-ion battery assembly 3-Cell PWCD-B Line cord B, North America 714030 PLFM power cord, North America...

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Cp 50 plus

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