Welch Allyn CP 100 Update To Directions For Use
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Welch Allyn CP 100 Update To Directions For Use

Electrocardiographs
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  • Page 1 CP Series Electrocardiographs CP 200 CP 100 Update to Directions for Use...
  • Page 2 Welch Allyn CP Series Electrocardiographs Copyright 2012 Welch Allyn Mat. Number: 719375, Ver: A Welch Allyn Regulatory Affairs Representative 4341 State Street Road Welch Allyn Limited Skaneateles Falls, NY 13153 Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland www.welchallyn.com...
  • Page 3 Update Through Software Version 2.6 This update describes changes in operation through software version 2.6 of the CP 100 and CP 200 electrocardiographs and the CP 200 spirometry option. This document supplements information in the following manuals: • CP 100 12-Lead Resting Electrocardiograph Directions for Use •...
  • Page 4 Welch Allyn CP Series Electrocardiographs Symbols Rechargeable lithium ion battery 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. Separate the battery from other Recycle disposables for recycling.

  • Page 5: Reviewing The Device Information

    Update Through Software Version 2.6 Selecting the Battery Type in the Device Configuration settings 1. Press the Menu key 2. Choose System Settings > Device Configuration. The following screen appears. “Device Configuration” Screen 9:17AM Oct 16 12 Device Configuration Lithium ion Lead-Acid 1 Set Date/Time 2 Language...

  • Page 6: Battery Specifications

    Welch Allyn CP Series Electrocardiographs Scroll to the bottom of the list to view your battery type (either Lead-Acid or Lithium). Item Description About Displays the following information about the electrocardiograph: • serial number • modules configured • version numbers •...

  • Page 7: Reset Button

    Feature updates prior to the 2.6 software release If your CP 100 electrocardiograph has a serial number of 10020000, or greater, or your CP 200 electrocardiograph has a serial number 20020000, or greater, this update describes the changes in the operation of your electrocardiograph.
  • Page 8 Welch Allyn CP Series Electrocardiographs reset button, insert a small object, such as small paper clip, into the hole next to the Spirometry port. Bi-Colored Keyboard LED Figure 2. Keyboard LED The bi-colored LED on the keyboard Bi-colored LED indicates the battery status. When green, the LED indicates that AC power is present.
  • Page 9 Updated Information for the CP 100/CP 200 Heart rate monitor operation The heart rate indicated on the CP 100 or CP 200 LCD display is for reference only. Make manual measurements of the ECG intervals and magnitudes on printed ECG reports only.
  • Page 10 • Replace the patient lead if the banana spring at the end of the lead is broken or damaged. Updated Battery Information for the CP 100/CP 200 Electrocardiograph Battery - Preparation and Operation Battery performance: The sealed lead-acid battery provides 200 to 300 discharge/charge cycles under normal operating conditions before it should be replaced.
  • Page 11 Charge the battery whenever possible by connecting the electrocardiograph to AC power after each use. The CP 100/CP 200 provides a trickle charge to keep the battery fully charged. Continuous charging will maximize the battery performance and longevity and will not overcharge or degrade the battery.

  • Page 12: Heart Rate

    Welch Allyn CP Series Electrocardiographs Update Through Software Version 2.5 This update describes changes in operation through software version 2.5 of the CP 100 and CP 200 electrocardiographs and the CP 200 spirometry option. This document supplements information in the following manuals: •...
  • Page 13 Update Through Software Version 2.5 Pacemaker Detection Prompt CP 100, CP 200 If the software detects the possible presence of a pacemaker, it now asks you whether the patient has a pacemaker. If you say no, interpretation (if purchased) is included in the report.

  • Page 14: External Printer

    Welch Allyn CP Series Electrocardiographs Test Directory Usability • CP 200 More convenient searching When searching the test directory, you can now enter partial search criteria in the Patient ID or Last Name fields. For example, to find all patient IDs starting with 12 (including 129374, 12579-125, and 12049-7564), you would enter 12 in the Patient ID field.
  • Page 15 SD card must be > 64 MB, < 2 GB. Note The CP 100 and CP 200 do not support SD card capacities greater than 2 GB including SDHC and SDXC high capacity SD card formats, or other USB storage devices that have software applications pre-installed such as SanDisk U3 Smart technology.
  • Page 16 CP 100, CP 200 You can now transfer the configuration of one electrocardiograph to another (CP 200 to CP 200, or CP 100 to CP 100). If you have the spirometry option, its configuration is included in the transfer. To transfer a configuration, follow these steps: 1.
  • Page 17 Update Through Software Version 2.5 7. The files are copied to the electrocardiograph, and then it reboots. Configuration file...
  • Page 18 Welch Allyn CP Series Electrocardiographs Spirometry Improvements • CP 200 Spirometry Option Quicker access to spirometry settings When the electrocardiograph is in spirometry mode, the Menu key immediately opens the Spirometry Settings menu. • PCP mode adjustments In PCP mode, the V/T scaling was changed to AUTO, so the PCP printout now fits on a single page.
  • Page 19 Update Through Software Version 2.5 Updated norm profiles Parameters Studied Gender Race Norm Name (Abbrev.) Berglund 1963 7 70 X X X (be) M:15–91 Crapo 1981 (cr) X X X X X X F:17–84 Dockery 1983 6–11 110–160 (do) ECCS/Quanjer M:155–195 X X X X X X X X...
  • Page 20 Welch Allyn CP Series Electrocardiographs “Intended use” statement expanded CP 100, CP 200 The Welch Allyn electrocardiograph and spirometry products (subject devices) are intended for use by trained operators in health facilities. The subject devices provide the following diagnostic functions: •...
  • Page 21 Update Through Software Version 2.5 Enhanced pediatric support CP 100, CP 200 An augmented lead set supports an alternate placement of the precordial leads on pediatric patients. This lead placement is easier to use on the small chests of infants and young children.

  • Page 22: Appendix A - Specifications

    Welch Allyn CP Series Electrocardiographs New Features With Software Version 2.5 Location of printed date and time changed The date and time on the ECG printout has been moved from the footer to the header on the ECG printout to make it easier to see and prevent confusion with other information printed in the footer.

  • Page 23: General Warnings

    CP 100 12-Lead Resting Electrocardiograph Directions for Use (mat. 708794) CP 200 12-Lead Resting Electrocardiograph Directions for Use (mat. 708793) If your CP 100 electrocardiograph has a serial number of 10020000, or greater, or your CP 200 electrocardiograph has a serial number 20020000, or greater, this update describes the changes in the operation of your electrocardiograph.
  • Page 24 Welch Allyn CP Series Electrocardiographs...

  • Page 25: Recording An Auto Ecg

    Directions for Use Chapter 5 Performing ECG Tests Recording an Auto ECG WARNING To avoid the risk of associating ECG reports with the wrong patients, each report must identify the patient. If any ECG report does not identify the patient, write the patient identification patient information on the report immediately following the ECG test.

  • Page 26: Recording A Normal Auto Ecg

    Chapter 5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Recording a Normal Auto ECG For a normal Auto ECG, you enter patient data and do other optional tasks before printing, as shown in Figure 31on page 48. To Record a Normal Auto ECG 1.
  • Page 27 Directions for Use Chapter 5 Performing ECG Tests Figure 33. Auto ECG Acquisition” Screen Doe, Jane Doe, Jane 9:17AM Oct 16 05 9:17AM Oct 16 05 HR 120 Auto ECG : Acquisition Auto ECG Acquisition Printing Report The electrocardiograph displays messages here when it is doing the following: Collecting Data •...
  • Page 28 Chapter 5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Figure 34.“Auto ECG Post-Print” Screen Doe, Jane 9:17AM Oct 16 05 Auto ECG : Post-Print 1. Exit 2. Print Copy 3. Repeat Test 4. Export Test 5. Select the desired item.
  • Page 29 Directions for Use Chapter 5 Performing ECG Tests 6. Press Exit to complete patient testing. WARNING Failure to follow these instructions could incorrectly associate an ECG test with the wrong patient. 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...
  • Page 30 Chapter 5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Recording a Stat Auto ECG WARNING To avoid the risk of associating ECG reports with the wrong patients, each report must identify the patient. If any ECG report does not identify the patient, write the patient identification information on the report immediately following the ECG test.

  • Page 31: Recording A Rhythm Ecg

    Directions for Use Chapter 5 Performing ECG Tests Recording a Rhythm ECG A Rhythm ECG is a continuous, real-time printout of three leads at a time. Rhythm ECGs are printouts only. They cannot be sent to an SD memory card or removable USB storage device.
  • Page 32 Chapter 5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph...
  • Page 33 Directions for Use Chapter 5 Performing ECG Tests Recording an Auto ECG WARNING To avoid the risk of associating ECG reports with the wrong patients, each report must identify the patient. If any ECG report does not identify the patient, write the patient identification information on the report immediately following the ECG test.
  • Page 34 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph Recording a Normal Auto ECG For a normal Auto ECG, you enter patient data and do other optional tasks before printing, as shown in Figure 36 on page 56. To Record a Normal Auto ECG 1.
  • Page 35 Directions for Use Chapter 5 Performing ECG Tests Figure 38. Auto ECG Acquisition” Screen Doe, Jane 9:17AM Oct 16 05 Auto ECG Acquisition HR 120 Softkeys for adjusting the AUTO waveforms or printing Baseline Muscle Print Leads Gain Filter Filter 4.
  • Page 36 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph Figure 39. “Auto ECG Post-Print” Screen Doe, Jane 9:17AM Oct 16 05 Auto ECG Post-Print HR 120 Softkeys for choosing post-printing options Print Edit Manual Repeat Exit Copy Test Save Test 8.
  • Page 37 Directions for Use Chapter 5 Performing ECG Tests 9. Press Exit to complete patient testing. WARNING Failure to follow these instructions could incorrectly associate an ECG test with the wrong patient. 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...
  • Page 38 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph Recording a Stat Auto ECG WARNING To avoid the risk of associating ECG reports with the wrong patients, each report must identify the patient. If any ECG report does not identify the patient, write the patient identification information on the report immediately following the ECG test.
  • Page 39 Directions for Use Chapter 5 Performing ECG Tests Recording a Rhythm ECG A Rhythm ECG is a continuous, real-time printout of a rhythm strip with a user-defined lead arrangement. For details on reviewing or changing the lead arrangement in your reports, see “Reviewing the Rhythm Report Settings”...
  • Page 40 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph...
  • Page 42 4341 State Street Road, PO Box 220, Skaneateles Falls, NY 13153-0220 USA 1 800 535 6663, + 1 315 685 4560 www.welchallyn.com Mat. Number: 719375, Ver: A...

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