CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Directions for use
© 2014 Welch Allyn , Inc. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from Welch Allyn. Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician.
iii Contents Introduction ............................................................................................. 1 About this document ........................................................................................... 1 Intended use ........................................................................................................ 1 Indications for use ................................................................................................ 1 About the test types ..............
iv Contents CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Storing the equipment ....................................................................................... 34 Discarding the equipment .................................................................................. 34 Troubleshooting .................................................................................... 35 Lead-quality problems ........................................................................................
1 Introduction About this document This document is written for clinical professionals with a working knowledge of medical procedures and terminology required for monitoring cardiac patients. Before using the electrocardiograph for clinical applications — or before setting up, configuring, troubleshooting, or servicing the electrocardiograph — you must read and understand this document and all other information that accompanies the electrocardiograph and related options or accessories.
2 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph About the test types Auto ECG 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.
Directions for use Introduction Features Pacemaker detection The software detects the possible presence of a pacemaker. If you confirm that the patient has a pacemaker, the ECG report includes no interpretation, and it indicates that a pacemaker was detected. Automatic ECG interpretation (optional) The optional MEANS interpretation algorithm, developed by the University of Rotterdam in the Netherlands, provides automatic analysis of ECG tests.
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 [Device] Four characters that indicate the device: CP50. [Feature] One or two characters that indicates the added feature: • Blank: A basic feature. • A: Includes automatic ECG interpretation. • P: Includes connectivity.
Directions for use Introduction 5 Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. This definition applies to both yellow and black and white symbols. Follow instructions/directions for use (DFU) -- mandatory action.
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 charging. (LED amber) AC power is present, and battery is charging. Battery is charged to the indicated level.
Directions for use Introduction 7 Separate the battery from other disposables for recycling. Recycle. Separate the device from other disposables for recycling. China RoHS (restriction of hazardous substances) symbols for control of pollution caused by electronic information products. 5-year environment-friendly use period (EFUP)for batteries. 10-year EFUP for the device. For details, see the accompanying documentation. See www.welchallyn.com/weee.
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.
Directions for use Introduction 9 WARNING To avoid serious injury or death, take these precautions during patient defibrillation: • Avoid contact with the electrocardiograph, patient cable, and patient. • Verify that the patient leads are properly connected. • Place defibrillator paddles properly in relation to electrodes. • After defibrillation, pull each patient lead out of the patient cable and inspect the tips for charring (black carbon marks).
10 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph CAUTION Do not pull or stretch the patient cable. Doing so could result in mechanical or electrical failures. Form the patient cable into a loose loop before storing. CAUTION Avoid positioning the patient cable where it might get pinched, stretched, or stepped on. Otherwise, measurements might no longer be accurate, and repair might be necessary.
11 Setup Connecting the patient cable WARNING Do not allow the conductive parts of the patient cable, electrodes, or associated connections of defibrillation-proof applied parts, including the neutral conductor of the patient cable and electrodes, to come into contact with other conductive parts, including earth ground. Otherwise, an electrical short might result, risking electric shock to patients and damage to the device.
12 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. • Do not expose it to solvents, adhesives, or cleaning fluids. • Do not store it with vinyls, plastics, or shrink wraps.
Directions for use To load a roll of thermal paper Setup 13
14 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. Regardless of the battery condition, you can use the electrocardiograph whenever it is plugged in. WARNING When you use AC power, always plug the electrocardiograph into a hospital-grade outlet to avoid the risk of shock.
Directions for use Setup 15 About the menu The menu provides access to the saved patient tests, the settings, and the service functions. From either of the main screens, you can reach the menu by touching the menu button. Viewing or changing the settings 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.
16 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph To view the device information 1. Touch the menu button. 2. Touch Settings > System > About or Upgrade. Verifying proper operation To ensure the accuracy of test data, you should verify proper operation of the electrocardiograph before it is used for the first time with patients. You should reverify proper operation once a year. To verify proper operation 1.
Setup Directions for use 17 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). No special software is required. The external printer prints auto ECG reports, always in black and white. (Rhythm ECGs always print to the internal printer.
18 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. To connect to a network-connected workstation via Ethernet cable 1. Connect the electrocardiograph to the same network as the workstation. If you need help, consult with your network administrator.
Directions for use Setup 19 The electrocardiograph is ready to communicate with the workstation. (To set up the workstation, see the instructions that came with the workstation connectivity software.
20 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph
21 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. To attach the leads to the patient 1. Prepare the patient. • Describe the procedure. Explain the importance of holding still during the test. (Movement can create artifact.
22 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. Secure the arm and leg clamps. Apply the Welsh cups (suction electrodes) to the chest.
Directions for use ECG tests 23 Electrode locations AHA IEC Location A V1 (red) C1 (red) Fourth intercostal space at the right sternal border. B V2 (yellow) C2 (yellow) Fourth intercostal space at the left sternal border. C V3 (green) C3 (green) Midway between V2 and V4. D V4 (blue) C4 (brown) Fifth intercostal space to the left of the midclavicular line. E V5 (orange) C5 (black) Anterior axillary line at the same horizontal level as V4.
24 ECG tests CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph AHA IEC I RL (green) N (black) J RA (white) R (red) Location Just above the right ankle. Just above the right wrist on the inside of the arm.
Directions for use ECG tests 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. Leads button Gain button (size) Speed button Filters button 2. If an Artifact message appears, minimize the artifact, as described under Troubleshooting.
26 ECG tests CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph • The Search button gives you access to patient data in the test directory or in a connected database (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.
27 Administrative tasks Turning the security option on or off (optional - available with CP 50 Plus only) The electrocardiograph incorporates security features that can keep patient data confidential. When the security option is off, user login is never required.
28 Administrative tasks CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph To manage the user list 1. Touch the menu button. 2. Touch Settings > System > Users. 3. Add, edit, delete, activate, or deactivate users. Turning the audit trail on or off (optional - available with CP 50 Plus only) An audit trail, a collection of information about user activity, may be helpful or even required for record-keeping.
Directions for use Administrative tasks 29 Managing the test directory The test directory is a group of ECG tests that have been saved in the electrocardiograph memory. 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: • Edit the patient data in saved tests.
30 Administrative tasks CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph
31 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. Never autoclave or steam clean the electrocardiograph or the patient cable.
32 Maintenance CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph 3. Dampen a cloth with any of the acceptable cleaning solutions, and wipe the exterior of the patient cable, reusable electrodes, and electrocardiograph. Dry all components with a clean, soft cloth, or paper towel. WARNING The patient cable and reusable elctrodes should be cleaned between each patient. 4. Before you turn on the electrocardiograph again, wait at least 10 minutes for all traces of liquid to evaporate.
Directions for use Maintenance To replace the battery Remove the old battery Insert the new battery 33
34 Maintenance CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Replacing the AC fuses You might need to replace one or both of the AC fuses if the AC power indicator does not light up when the electrocardiograph is connected to AC power. WARNING Failure to unplug could result in electrocution. To replace the AC fuses If either fuse is dark or has a broken wire, replace the fuse. Line up the fuse case with the opening; it goes in only one way.
35 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.
36 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. • The arm or leg electrode straps are too tight. Actions • Verify that the patient is comfortable, warm, and relaxed. • Check all electrode contacts. • If interference persists, turn the muscle-tremor filter on.
Directions for use Troubleshooting 37 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. • A lead might be defective. Actions • Replace the electrode. • Verify that the patient’s skin has been properly prepared. • Verify that electrodes have been properly stored and handled. • Replace the patient cable.
38 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. Actions • Check the AC power source. • Check the AC fuses. The electrocardiograph won't turn on when it is unplugged Causes • The battery is disconnected or incorrectly connected. • The battery is low, not charging, depleted, or bad.
Directions for use Troubleshooting 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. • Touch the Settings tab. Touch the Advanced tab.
40 Troubleshooting CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Limited warranty Welch Allyn, Inc., warrants that the CP 50 and CP 50 Plus electrocardiographs (the Products) meet the labeled specifications of the Products and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase, exceptthat accessories used with the Products are warranted for 90 days after the date of purchase. Such accessories include cables, electrodes, and battery.
Directions for use Troubleshooting 41 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.
42 Troubleshooting CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph
43 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 Resolution WQVGA, 480 x 272 Thermal paper Z-fold 11.4 cm (4.5 in.) x 250 sheets Roll 11.4 cm (4.5 in.
44 Specifications CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph Item Specification Report formats, external printer* 3x4 @ 25 mm/s, 3x4 @ 50 mm/s, 3x4 + 1R @ 25 mm/s, 3x4 + 3R @ 25 mm/s, Auto ECGs 3x4 - 5.0s @ 25 mm/s, 3x4 - 5.0s @ 50 mm/s, 6x2 - 5.0s @ 25 mm/s, 12x1 - 5.
Directions for use Specifications 45 Item Specification Electrodes Rigorously tested for conductivity, adhesion, and hypoallergenic qualities, and exceed all AAMI standards Power cable Meets or exceeds Type SJT.
46 Specifications CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph
47 Guidance and manufacturer’s declarations EMC compliance Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment. 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 website: http://www.welchallyn.com/apps/products/product_category.jsp?catcode=CARDIO.
