Welch Allyn CP 150 Directions For Use Manual
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Welch Allyn CP 150 Directions For Use Manual

12-lead resting electrocardiograph
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CP 150 12-lead resting
electrocardiograph
Directions for use
Software version 2.10.XX

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Summary of Contents for Welch Allyn CP 150

  • Page 1 CP 150 12-lead resting electrocardiograph Directions for use Software version 2.10.XX...
  • Page 2 © 2016 Welch Allyn, Inc. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.Welch Allyn assumes no responsibility for any injury, or for...

  • Page 3: Table Of Contents

    Contents Introduction ..................... 1 About this document ................... 1 Intended use ......................1 Indications for use ....................1 Contraindications ....................1 Description ......................1 Features ....................... 2 Configuration options for CP150 electrocardiograph ........... 3 Controls, indicators, and connectors ..............5 Symbols .......................
  • Page 4 Contents CP 150 12-lead resting electrocardiograph Regional ......................39 Device ........................ 40 Data management ..................... 41 Ownership ......................41 Start Demo ......................42 Network ......................42 Service ....................... 49 Maintenance ..................53 Cleaning the equipment ..................53 Inspecting the equipment .................. 54 Testing the electrocardiograph ................

  • Page 5: Introduction

    Intended use The Welch Allyn CP150 ™ is an electrocardiograph used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

  • Page 6: Features

    Spirometry (optional) The CP 150 spirometry option allows the user to acquire, view, store, and print, measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These...

  • Page 7: Configuration Options For Cp150 Electrocardiograph

    Directions for use Introduction 3 measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. Configuration options for CP150 electrocardiograph Model Accessories Language Power cord CP150 1 - AHA, disposable EN - English 2 - Europe A - Interpretation...
  • Page 8 4 Introduction CP 150 12-lead resting electrocardiograph Model Accessories Language Power cord S - Spirometry 3 - AHA, reusable W - WiFi 4 - IEC, reusable The spirometry option is only available in English. Note Examples: CP150S-1ENB and CP150AS-1ENB...

  • Page 9: Controls, Indicators, And Connectors

    Directions for use Introduction 5 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 10 6 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 11: Symbols

    Meets essential requirements of the of the DFU is available on this website. A European Medical Device Directive 93/ printed copy of the DFU can be ordered 42/EC from Welch Allyn for delivery within 7 calendar days. Power symbols Power on/standby Battery...
  • Page 12 8 Introduction CP 150 12-lead resting electrocardiograph Connectivity symbols Ethernet Wireless radio symbols Wireless signal strength Non-ionizing electromagnetic radiation • Best (4 bars) • Good (3 bars) • Fair (2 bars) • Weak (1 bar) • No connection (no bars)
  • Page 13 Directions for use Introduction 9 Separate collection of Electrical and China RoHs Electronic Equipment. Do not dispose as unsorted municipal waste. Lithium ion battery Keep away from sunlight IP20 Protected against the ingress of solid Use by Date foreign objects ≥ 12.5 mm diameter, not protected against the ingress of water.

  • Page 14: General Warnings

    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.
  • Page 15 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: General Cautions

    12 Introduction CP 150 12-lead resting electrocardiograph WARNING To avoid the risk of associating reports with the wrong patients, make sure that each test identifies the patient. Do not save a test to the patient record without patient identification associated with the report.
  • Page 17 Directions for use Introduction 13 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 18 14 Introduction CP 150 12-lead resting electrocardiograph...

  • Page 19: 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 20: Powering The Electrocardiograph

    16 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 21: Secure The Ac Power Cord Around The Cord Wrap Of The Mobile Stand

    WARNING Avoid positioning any leads or cables so that they could easily trip someone or become wrapped around a patient’s neck. Welch Allyn recommends looping the power cord around the mobile stand cord wrap as shown. 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.
  • Page 22 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, contact Welch Allyn Technical Support.

  • Page 23: 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: • Patient Icon and Patient name. Once the patient context is established, the format of the Patient name appears as last name, first name.
  • Page 24 20 ECG home screen CP 150 12-lead resting electrocardiograph • Battery status • Error or information messages. These items are displayed until the condition has been resolved. Content area The Content area includes 3 test selection buttons and a preview selection button: •...
  • Page 25 Directions for use ECG home screen 21 Example ECG report...
  • Page 26 22 ECG home screen CP 150 12-lead resting electrocardiograph...

  • Page 27: Ecg Tests

    ECG tests Attach 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: View Electrode Placement

    24 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 29: Electrode Locations

    Directions for use ECG tests 25 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 30: Use The New Patient Tab To Perform An Auto Ecg Test

    26 ECG tests CP 150 12-lead resting electrocardiograph Use the New Patient tab to perform an Auto ECG test CAUTION Patient data is not saved until the ECG test is completed. The ECG configuration settings can be changed in the Settings tab. The...
  • Page 31 Directions for use ECG tests 27 Item Button Leads button ECG preview button Gain button (size) Speed button Filters button If desired, touch (torso button) to enlarge the Note electrode placement (ECG preview) screen. Any flashing dots on the screen indicate unattached or poorly attached leads.
  • Page 32 28 ECG tests CP 150 12-lead resting electrocardiograph • USB mass storage device (Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation.) • Workstation (includes DICOM image server) • Remote file location 11.
  • Page 33 Directions for use ECG tests 29 Perform an Auto ECG test using the Search tab CAUTION Patient data is not saved until the ECG test is completed. Note The ECG configuration settings can be changed in the Settings tab. The following settings may appear differently if the default settings have been modified.
  • Page 34 30 ECG tests CP 150 12-lead resting electrocardiograph Assign an Auto ECG test to the worklist You can assign an Auto ECG test to the worklist if patient demographic fields are left blank. CAUTION Patient data is not saved until the ECG test is completed.

  • Page 35: Saved Tests

    Saved tests Search for saved tests Search for Saved Tests by: • Date • Last name • Patient ID • Test type ○ ○ Unconfirmed ○ Unprinted ○ Unsent Once retrieved, Saved Tests can be deleted, printed, edited, or sent to a USB storage device, Workstation, or a Remote file location.
  • Page 36 32 Saved tests CP 150 12-lead resting electrocardiograph...

  • Page 37: Manage Worklist

    Manage worklist Download the worklist when connected to the Worklist server The worklist is a group of patients whose demographic data has been downloaded into the electrocardiograph memory to be recalled for a test later that day. The worklist holds up to 50 patients.
  • Page 38 34 Manage worklist CP 150 12-lead resting electrocardiograph...

  • Page 39: Settings

    Settings View or change 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 40 36 Settings CP 150 12-lead resting electrocardiograph Modify the settings as desired: • Default speed • Print options Touch (Next). Modify the settings as desired: • Rhythm leads 1 - 12 Touch the Auto report tab. Modify the settings as desired: •...

  • Page 41: View Or Change The Device Information

    Directions for use Settings 37 View or change the device information To view or change the device information 1. Touch the Settings tab. The ECG tab appears. 2. Touch the Device tab. Modify the settings as desired: • LCD brightness •...
  • Page 42 38 Settings CP 150 12-lead resting electrocardiograph...

  • Page 43: Advanced Settings

    Advanced settings The Advanced tab provides password-protected access to the CP150's Advanced settings (or Admin mode), enabling administrators, biomedical engineers, and/or service engineers to configure specific features. The Advanced tab also presents read-only information about the CP150. Access Advanced settings You cannot access Advanced settings if a patient test is in progress.

  • Page 44: Device

    40 Advanced settings CP 150 12-lead resting electrocardiograph Time zone Select your time zone offset from Coordinated Universal Time (UTC). Daylight savings offset Select daylight savings time. Automatically adjust clock for daylight savings time, Select this to adjust the displayed time by +/- one hour reported by Connex when the connected host reports daylight savings time.

  • Page 45: Data Management

    Directions for use Advanced settings 41 Data management Specify data management settings 1. Access the Advanced Settings. a. Touch the Settings tab. b. Touch the Advanced tab. c. Enter the Advanced settings code. d. Touch OK. The General tab appears on the bottom of the screen and the Regional tab appears on the top of the screen.

  • Page 46: Start Demo

    42 Advanced settings CP 150 12-lead resting electrocardiograph Setting Action/Description Practice ID Use the keyboard to add the Practice identification. Touch Contact information Use the keyboard to add the Contact information. Touch Device ID Use the keyboard to add Device identification. Touch 4.
  • Page 47 To exit the Advanced Settings and return to the Home tab, touch Exit. Specify Ethernet settings You can connect a CP150 electrocardiograph to a Welch Allyn CardioPerfect workstation or a network server via an Ethernet cable. Software provided in the CP 50/150 connectivity kit is required to communicate with the workstation.
  • Page 48 44 Advanced settings CP 150 12-lead resting electrocardiograph Network IP address Touch and enter the IP address to manually set up the device for Ethernet communications. Subnet mask Touch and enter the Subnet mask. Gateway IP address that routes packets to other networks. Touch and enter the Gateway address.
  • Page 49 1. In Advanced settings, touch the Network > Radio > Security tabs. 2. Select the encryption method to secure data transfer from the device. Note Network server certificates are required for all EAP security options. Use the Welch Allyn Service Tool to load these certificates. 3. Specify Security settings. Setting...
  • Page 50 46 Advanced settings CP 150 12-lead resting electrocardiograph Note None of the changed radio settings take effect until you touch Update radio. 4. Do one of the following: • To continue in Advanced settings, touch another tab. • To exit Advanced settings and return to the Home tab, touch Exit.
  • Page 51 Directions for use Advanced settings 47 d. Touch OK. The General tab appears at the bottom of the screen and the Regional tab appears at the top of the screen. 2. Touch the Network tab. 3. Touch the Server tab. The Connex and DICOM vertical tabs appear.
  • Page 52 48 Advanced settings CP 150 12-lead resting electrocardiograph Setting Action/Description Enable worklist downloads and ECG DICOM uploads Select this option to enable DICOM functionality. Local AE Title Touch and enter the AE Title for the device (Example: CP150). Enter a maximum of 16 characters.

  • Page 53: Service

    Connect the CP 150 to an AC power outlet before upgrading the software. 1. Download the Welch Allyn Service Tool and Partner Connect and install on your PC. 2. Follow the instructions to set up a user name and password.
  • Page 54 50 Advanced settings CP 150 12-lead resting electrocardiograph 3. Plug your CP 150 device into a USB port on your PC running the Welch Allyn Service Tool and turn on the device. Plug your CP 150 device into AC power.
  • Page 55 Allyn. Use this code to activate the new feature or features. 1. Download the Welch Allyn Service Tool and Partner Connect and install on your PC. 2. Plug your CP 150 device into a USB port on your PC running the Welch Allyn Service Tool and turn on the device.
  • Page 56 52 Advanced settings CP 150 12-lead resting electrocardiograph At the Install License screen, click OK. CAUTION Do not disconnect or power off the device during the license installation. 7. Once you see the Add new features screen confirming the license installation, click Close.

  • Page 57: 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 58: 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 59: Replacing The Battery

    Directions for use Maintenance 55 • 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 60: Storing The Equipment

    56 Maintenance CP 150 12-lead resting electrocardiograph 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.

  • Page 61: 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 62 58 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 63 Directions for use Troubleshooting 59 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 64: System Problems

    60 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 65 Directions for use Troubleshooting 61 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 66 62 Troubleshooting CP 150 12-lead resting electrocardiograph...

  • Page 67: Service Policy

    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 68 64 Service policy CP 150 12-lead resting electrocardiograph...

  • Page 69: Limited Warranty

    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 70 66 Limited warranty CP 150 12-lead resting electrocardiograph...

  • Page 71: General Compliance And Standards

    EN/ISO 14971 EN/ ISO 10993-1 EN/ISO 26782 (Spirometry Option) Declaration of Conformity Available upon request. Device radio The CP 150 radio operates on 802.11 networks. Wireless network IEEE 802.11 a/b/g/n interface Frequency 2.4 GHz frequency bands 5 GHz frequency bands 2.4 GHz to 2.483 GHz...
  • Page 72 68 General compliance and standards CP 150 12-lead resting electrocardiograph Antenna Ethertronics WLAN_1000146 Wireless data rates 802.11a (OFDM): 6, 9, 12, 18, 24, 36, 48, 54 Mbps 802.11b (DSSS, CCK): 1, 2, 5.5, 11 Mbps 802.11g (OFDM): 6, 9, 12, 18, 24, 36, 48, 54 Mbps 802.11n (OFDM,HT20,MCS 0-7): 6.5,13,19.5, 26, 39,52, 58.5, 72.2 Mbps...

  • Page 73: General Radio Compliance

    Some countries restrict the use of 5-GHz bands. The 802.11a radio in the Note CP 150 uses only the channels indicated by the access point with which the radio associates. The hospital IT department must configure access points to operate with approved domains.

  • Page 74: Industry Canada (Ic) Emissions

    This booklet is available from the U.S. Government Printing Office, Washington, D.C. 20402. Stock No. 004-000-0034504. Welch Allyn is not responsible for any radio or television interference caused by unauthorized modification of the devices included with this Welch Allyn product, or the substitution or attachment of connecting cables and equipment other than specified by Welch Allyn.

  • Page 75: European Union

    Undertegnede Welch Allyn erklærer herved, at følgende udstyr RLAN device overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF Dutch Bij deze verklaart Welch Allyn dat deze RLAN device voldoet aan de essentiële eisen en aan de overige relevante bepalingen van Richtlijn 1999/5/EC. English Hereby, Welch Allyn, declares that this RLAN device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

  • Page 76: Emc Guidance And Manufacturer's Declarations

    72 General compliance and standards CP 150 12-lead resting electrocardiograph Italian Con la presente Welch Allyn dichiara che questo RLAN device è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE. Latvian Ar šo Welch Allyn deklarē, ka RLAN device atbilst Direktīvas 1999/5/EK būtiskajām prasībām un citiem ar to saistītajiem noteikumiem.
  • Page 77 Directions for use General compliance and standards 73 Electromagnetic emissions The CP150 is intended for use in the electromagnetic environment specified below. The customer or user of the CP150 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions...
  • Page 78 74 General compliance and standards CP 150 12-lead resting electrocardiograph Electromagnetic immunity The CP150 is intended for use in the electromagnetic environment specified below. The customer or the user of the CP150 should assure that it is used in such an environment.
  • Page 79 Directions for use General compliance and standards 75 Recommended separation distances between portable and mobile RF communications equipment and the CP150 Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Rated max.
  • Page 80 76 General compliance and standards CP 150 12-lead resting electrocardiograph...

  • Page 81: 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 5.3 kg (11.7 lb) Keyboard type (power button) Polyester overlay Display Type TFT, 18 cm (7 in.) color touch screen...
  • Page 82 78 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 83 Because of the sampling characteristics and the asynchronism between sample rate and signal rate, digital ECG systems such as the CP 150 may produce a noticeable modulating effect from one cycle to the next, particularly in pediatric recordings. This phenomenon is not physiologic.
  • Page 84 80 Specifications CP 150 12-lead resting electrocardiograph...

  • Page 85: Appendix

    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 150 719654 10-lead ECG patient cable, IEC, banana, CP 150 721328 10-lead ECG patient cable, AHA, banana (1.5M/5 feet), CP 150...
  • Page 86 CP 150 Office cart (cable arm and shelf sold separately) 105342 CP 150 Hospital cart (cable arm and shelf sold separately 105343 CP 150 Cable arm and shelf cart option (compatible with the CP 150 office and hospital carts) Miscellaneous items Part Number Description...
  • Page 87 Directions for use Appendix 83 Part Number Description 719728 Welch Allyn Service Tool Flyer Quick Reference Guide 724162 Quick Reference Guide, Printed Copy, English 724166 Quick Reference Guide, Printed Copy, French 724169 Quick Reference Guide, Printed Copy, German 724165 Quick Reference Guide, Printed Copy, Dutch 724167 Quick Reference Guide, Printed Copy, Eur.

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