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CP100 Electrocardiograph User Manual
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1. AC power inlet On Off key Green LED Directions for Use Chapter2 Setting Up the Electrocardiograph 23 To Turn the Electrocardiograph On Press 0 To Turn the Electrocardiograph Off Press and hold Note If PowerSave is enabled the electrocardiograph turns off automatically after several idle minutes To learn how to enable or disable Power Save see Reviewing the Device Configuration Settings on page 27 Verifying Proper Operation Once your electrocardiograph is set up verify proper operation by using an ECG simulator to acquire and print a standard 12 lead ECG of known amplitude See Step 2 on page 59 Note As part of your initial set up you may want to adjust the display contrast To learn how see Reviewing the Device Configuration Settings on page 27 You may also want to change other software settings as described in the following chapters e Reviewing the System Settings on page 25 e Reviewing the ECG Settings on page 31 24 Chapter2 Setting Up the Electrocardiograph Welch Allyn CP 100 Electrocardiograph Connecting an External USB Printer Optional If desired you can connect an external printer It must be a USB inkjet or laser printer that supports PCL printer control language such as the following Vendor Model PCL Version HP Deskjet 995c PCL 3 HP Deskjet 5650 PCL 3 enhanced HP Laser 1022 PCL 5E Dell Laser 1710 PCL 5E amp PCL 6 Lexmark Laser E240 PCL
2. Default Gain Setting Default Baseline Filter Default Muscle Filter Mains Filter Directions for Use Chapter 4 Reviewing the ECG Settings 33 About Auto ECG Reports An Auto ECG is a report of ECG data in a userdefined format For an example see Figure 21 To learn how to set up or interpret a report see the references on page 34 Figure 21 Auto Report Example 3x4 3R Lead Arrangement A Patient data B ECG measurements C Interpretation optional N siya mal ld e aa moya al Nad gt D Report status label gt E 3 rows 4 columns A SERA d gt E Rhythm leads s gt P Paga m 1 ja 9 e o vt N 0 Calibration M Gain pulse ten nar uo m s G Software version K AC filter H Device ID N Paper speed L Frequency range Practice ID J Date and time 34 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 100 Electrocardiograph Item in Figure 21 on page 33 Description A B Patient data ECG measurements Interpretation optional Report status label 3 rows 4 columns Rhythm leads Software version Device ID Practice ID Date and time AC filter Frequency range Gain Paper speed Calibration pulse See Reviewing the Patient Data Fields Available on page 37 Standard See Reviewing the Interpretation and Copy Settings for Auto Reports on page 36 See Reviewing the Interpretation and Copy Settin
3. Weight Unit Height Unit Power Save Practice ID Device ID Audio Beeper Increase Contrast Decrease Contrast Contact Information Printer Select CAPS Lock Device Info About Print Settings Manage Settings Enable Options Upgrade Software Service Info Directions for Use Chapter 3 Reviewing the System Settings 27 Reviewing the Device Configuration Settings 1 Press the Menu key 2 Choose System Settings gt Device Configuration The following screen appears Figure 18 Device Configuration Screen HL 9 17AM Oct 16 08 Device Configuration 1 Set Date Time 2 Language 3 Date Format 4 Time Format 5 Weight Unit 6 Height Unit 7 Power Save i 8 Practice ID 3 Change any desired settings Setting Description Set Date Time Current date and time Language List of languages available Changes take effect when the next screen appears Date Format MM DD YY month day year DD MM YY day month year Time Format 24 hour or AM PM Weight Unit Kilograms kg or pounds Ib Height Unit Centimeters cm inches in or feet and inches ft in Power Save On or off When on the electrocardiograph turns itself off after several idle minutes Practice ID Name of the practice clinic or hospital This ID prints on all ECG reports Device ID Electrocardiograph identification Enter up to 20 characters This ID prints on all EC
4. Compatibility with CardioPerfect workstation software Store and manage data electronically by transferring records to a Welch Allyn CardioPerfect workstation via an SD memory card or removable USB storage device media not included Compatibility with external printer You can connect an external printer For details see Connecting an External USB Printer Optional on page 24 4 Chapter 1 Introduction Welch Allyn CP 100 Electrocardiograph Pacemaker detection If the software detects the possible presence of a pacemaker it asks you whether the patient has a pacemaker If you say no interpretation if purchased is included in the report If you say yes interpretation is not included in the report and a message indicating that a pacemaker was detected is displayed on the report Support for augmented pediatric lead set The augmented pediatric lead set an alternate placement of the precordial leads on pediatric patients is easier to use on the small chests of infants and young children It provides optimal vectors for early development of the heart for the change of right to left ventricular dominance For electrode placement locations see Figure 28 on page 46 Directions for Use Options Chapter 1 Introduction These options are available both for initial purchases and for upgrades Automatic ECG interpretation The optional MEANS interpretation algorithm developed by the University of Rotterdam in the Netherlands pro
5. Menu Tre 1 cece enn 32 About Auto ECG Reports 0 00 ccc eee ene tenes 33 Reviewing the Auto Report Settings 0 0 eee eee 39 Reviewing the Miscellaneous ECG Settings 00 cece eee ees 40 Turning the Augmented Pediatric Lead Set On and Of 41 31 This chapter documents the ECG settings For information on the following related tasks see the procedures identified here e Reviewing system settings See Reviewing the System Settings on page 25 e Printing all settings See Reviewing the Device Information on page 29 32 Chapter 4 Reviewing the ECG Settings ECG Settings Menu Tree Welch Allyn CP 100 Electrocardiograph ECG Settings Edit _ Auto Report Auto Report Settings Baseline Centering Lead Timing Format Artifact Report QTc Method H Lead Arrangement Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Extended Measurements Average Cycles Interp Settings E Print Interpretation Copies Copies With Interp Reason Statements Unconfirmed Report Abnormal ECG Patient Data First Name Middle Initial Age Birthdate Weight Height Gender Race Medication History BP Comments Augmented Lead Set Miscellaneous Lead Configuration Electrode Labels
6. graphical presentations and interpretative statements on an advisory basis These are presented for review and interpretation by the clinician based upon knowledge of the patient the result of physical examination the ECG tracings and other clinical findings Directions for Use Chapter 1 Introduction 3 Indications for Use The electrocardiograph is one of the tools that clinicians use to evaluate diagnose and monitor patient cardiac function The 12 lead ECG interpretive algorithm provides a computergenerated analysis of potential patient cardiac abnormalities which must be confirmed by a physician with other relevant clinical information Standard Features amp Benefits Full alphanumeric keypad Enter patient information quickly and easily LCD display Enter data and program the system easily Unlimited storage on removable media Use SD memory cards or removable USB storage devices to save as many ECG records as you like Media are not included If both an SD memory card and a USB storage device are connected files are sent to the SD card For media specifications see Standard connectivity on page 74 Battery operation Use the electrocardiograph almost anywhere On battery power you can print up to 100 ECGs continuously before needing to recharge User definable ECG report format Customize the report format for efficient reporting Removable leads for ECG patient cable Replace leads individually if needed
7. see page ii Shutdown was pressed while printing a Rhythm ECG To shut down press m To cancel the shutdown press x Temperature Error Printer head temp is too high Allow to cool then try again Directions for Use Chapter7 Troubleshooting n Limited Warranty Welch Allyn Inc warrants that the Cardiopulmonary line of electrocardiographs including the CP 100 and CP 200 models the Products meet the labeled specifications of the Products and will be free from defects in materials and workmanship that occur within 3 years after the date of purchase except that accessories used with the Products are warranted for 90 days after the date of purchase Such accessories include lead wires cabling electrodes and battery The date of purchase is 1 the date specified in our records if you purchased the Product directly from us 2 the date specified in the warranty registration card that we ask you to send to us or 3 if you don t return the warranty registration card 30 days after the date on which the Product was sold to the dealer from whom you bought the Product as documented in our records This warranty does not cover damage caused by 1 handling during shipping 2 use or maintenance contrary to labeled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents If a Product or accessory covered by this warranty is determined to be defective becaus
8. 6 No special software is required The external printer prints the following always in black and white e Auto ECG reports e Device settings e Help pages Rhythm ECGs always print to the internal printer See the warning regarding signal I O connectors on page 15 To Connect a Printer Connect one end of a USB cable to the printer s USB connector and connect the other end to the electrocardiograph s USB connector 10101 For connector location see Figure 5 on page 8 To learn how to enable the external printer in the settings see Reviewing the Device Configuration Settings on page 27 3 Reviewing the System Settings System Settings Menu Tree 00 c cece eee nn 26 Reviewing the Device Configuration Settings 27 Reviewing the Device Information llle eee eee eee eee 29 Transferring a Configuration to Another Electrocardiograph 30 This chapter documents the system settings For information on the following related tasks see the procedures identified here e Reviewing ECG settings See Reviewing the ECG Settings on page 31 e Printing all settings See Reviewing the Device Information on page 29 25 26 Chapter 3 Reviewing the System Settings System Settings Menu Tree System Settings Welch Allyn CP 100 Electrocardiograph Device Configuration Set Date Time Language Date Format Time Format
9. 67 Problem Solving Suggestions sec esie en REX ee oe ROSE 68 Limited Warranty s ses mpa Nan PAGA EY Ex EG EMI ee penis 71 SehvICe RO es atat ls a net e Aga tat pee cg P tela eso Nang Aahh ted A 72 A Specifications cartera lata pag aba bL REA RENS 73 B EMC Guidance and Manufacturer s Declarations 7b Glossario sedet eto siTe ric bI QI PUEDE UE ET HS 79 Introduction About This Manual lisse I rrr 2 Product Overviews a ded Wade ao eo ac e wt wc a de 2 Intended Use coco ex KGG a eigo od cR Ee A eus x RC Rio 2 Indications Tor USE sos s el E haa a NDN 3 Standard Features amp Benefits isses cese ec ke PEE eee ews 3 OP in o x en MR mr unm E m ma CR REG Rr A AA ek 5 ACGBSSDEOS oii errari ING asl eed dn e c xg c ba bor ck A 6 Controls Indicators and Connectors eee eee nA 7 About the Main MENU 4 Kan PEG ABRA eto EGO eae E ee NAG 10 Moving Through the Menus 2000 c eee ree 11 About the Patient Cable and Leads 0000 cece cence teens 12 o O ahead ABA aed REE AG gee Bade Rd eR Ole A eg dd 13 Using the Electrocardiograph Safely 0 0 cee eee eee eee eee 15 Getting Help oe eue ae ae Rissa sc SUR Su Roses cx A ee IRE Ro Re Ra pe Ses ee del a ta 18 2 Chapter 1 Introduction Welch Allyn CP 100 Electrocardiograph About This Manual This manual is written for clinical professionals with a working knowledge of medical procedures and terminology as required for monitoring
10. DE ee dag e s 6 Controls Indicators and Connectors ereere edet eui eee Eheee ieie 7 About the Main Menu nex ate aly e Pere EP Bae hse Eee aly 10 Moving Through the Menus ss 11 About the Patient Cable and Leads 0 0 0 0 00 cee 12 SO en ctr trate sed ates eat LA tah of atc Nd de ae desi ange dct eal A 13 Using the Electrocardiograph Safely 0 lille 15 General Warnings sss hhc Bok ec tic oct oye Ee a a eA Ea 15 General Cautions te eos ee ae SA es HIS BUAYA eed 17 Getting Helps Bak NA KAMING NA NPA hn BAS oe de tA OE Poder 18 2 Setting Up the Electrocardiograph 19 Inspecting the Electrocardiograph 000000 eee 20 Connecting the Patient Cables essi sesgar si resen ey nee 20 Loading the Thermal Chart Paper aden e ra R 0 A A O E A AIE 21 Powering the Electrocardiograph aaa less 22 Verifying Proper Operation o o ooooo eee ee 23 Connecting an External USB Printer Optional nonna anaana aea 24 3 Reviewing the System Settings a n anaana aaeeea 25 System Settings Menu Tree llle 26 Reviewing the Device Configuration SettingS o oooooooooo ooo 27 Reviewing the Device Information 0c e eee eee 29 Transferring a Configuration to Another Electrocardiograph 30 iv Contents Welch Allyn CP 100 Electrocardiograph 4 Reviewing the ECG SettingS 00 a 31 ECG Settings Menu Tree y ou epe D Sos als TEST
11. Description About Print Settings Manage Settings Enable Options Upgrade Software Service Info Displays the following information about the electrocardiograph e serial number e modules configured e version numbers Prints your ECG and system settings See Transferring a Configuration to Another Electrocardiograph on page 30 Contact Technical Support For phone numbers see page ii Contact Technical Support For phone numbers see page ii Accessible to service support only 30 Chapter 3 Reviewing the System Settings Welch Allyn CP 100 Electrocardiograph Transferring a Configuration to Another Electrocardiograph You can transfer your configuration from one CP 100 electrocardiograph to another To Transfer a Configuration 1 Insert a storage device SD memory card or removable USB device into an electrocardiograph that is configured as desired Press the Menu key Choose System Settings gt Device Info gt Manage Settings gt Export Files gt Export Configuration Files The files are copied to the storage device Remove the storage device and insert it into another CP 100 electrocardiograph Choose System Settings gt Device Info gt Manage Settings gt Import Files gt Import Configuration Files The files are copied to the electrocardiograph and then it reboots Figure 20 Configuration File Transfer Configuration file Reviewing the ECG Settings ECG Settings
12. ECG settings system settings Shift key 9 simultaneous lead timing 39 specifications 73 74 speed settings See thermal chart paper speed settings stat Auto ECGs 48 53 Stop Cancel key 9 storage instructions 65 supplies 6 71 symbols and markings 13 14 system settings 10 25 29 T Technical Support ii testing the electrocardiograph 59 thermal chart paper loading 21 ordering 6 specifications 73 speed settings 33 34 55 time and date See date and time timing lead 39 troubleshooting 67 70 U ultrasound machines use with 17 Unconfirmed label 33 34 36 See also interpretation of ECGs automatic confirming upgrades 5 29 URL ii USB port Com port B 8 USB storage devices 3 74 V V1 V2 V3 etc See AHA electrode labels versions 29 33 34 84 Index W wall poster ordering replacement 6 warning symbol defined 13 warranty 71 waveforms ECG See leads web site ii weight unit setting 27 Welch Allyn Technical Support ii Welch cups ordering 6 workstation See CardioPerfect workstation Welch Allyn CP 100 Electrocardiograph WelchAllyn 4341 State Street Road PO Box 220 Skaneateles Falls NY 13153 0220 USA 1 800 535 6663 1 315 685 4560 www welchallyn com Advancing Frontline Care Reorder Number multi language CD 401150 Mat Number manual only 708794 Ver F
13. Place defibrillator paddles properly in relation to electrodes e After defibrillation pull each patient lead out of the patient cable and inspect the tips for charring black carbon marks If there is any charring the patient cable and individual leads must be replaced If there is no charring fully reinsert the leads into the patient cable Charring can occur only if a lead is not fully inserted into the patient cable before defibrillation WARNING To prevent the spread of infection take these precautions e Dispose of single use components for example electrodes after using them once e Regularly clean and disinfect all components that come in contact with patients See Cleaning the Equipment on page 58 e Avoid ECG testing for patients with open infectious sores WARNING Avoid positioning any leads or cables so that they could easily trip someone or become wrapped around a patient s neck WARNING Satisfactory maintenance procedures must be implemented or equipment failure and health hazards may result WARNING Only qualified service personnel should attempt to repair the electrocardiograph In case of a malfunction call Technical Support and precisely describe the problem For phone numbers see page ii Directions for Use Chapter 1 Introduction 17 General Cautions The following caution statements apply to electrocardiograph use in general Caution statements that apply specifically to particular procedures such
14. Transmitter W d 1 17 JP d 1 17 JP d 2 33 JP 0 01 0 117 0 117 0 233 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distan ce din meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 79 Glossary AHA An abbreviation for American Heart Association The AHA electrode labeling scheme is most commonly used in the United States Auto ECG A report typically showing a 10 second acquisition of 12 leads of ECG information combined with patient data interpretation and measurements matrix See also Rhythm ECG average cycles Dominant waveforms for all 12 leads Printed on a separate page if enabled CardioPerfect workstation A PC using Welch Allyn CardioPerfect software Stores ECG and spirometry test data Can communicate with other electronic patient information systems such as billing and medical records confirmed unconfirmed Status of an Auto ECG report s interpret
15. Waveforms llle 55 43 44 Chapter5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Connecting the Leads to the Patient 1 Help the patient get comfortable Patient preparation is important for a successful ECG a Describe the procedure If desired press the Help key 2 and print the page entitled What Is An ECG for the patient to read b Help the patient get warm and relaxed Excessive patient movement could interfere with the operation of the electrocardiograph c Putthe patient in a reclining position with the head slightly higher than the heart and legs WARNING ECG electrodes could cause skin irritation Examine the skin for signs of irritation or inflammation Prepare electrode locations See Figure 27 on page 45 or Figure 28 on page 46 a Shave if necessary b Clean with alcohol or acetone c Allow to dry Attach the electrodes and lead wires securely e For reusable electrodes Straps must neither slide nor be so tight as to cause discomfort The electrode paste gel or creme must cover an area the size of the electrode but no larger especially on the chest e For disposable tab electrodes Place the electrode tab between the jaws of the electrode adapter keeping the tab flat Gently tug on the adapter to ensure that it is properly placed on the electrode Each time you remove and reattach an electrode the conductive gel becomes weaker and less effective Direction
16. accessories according to local laws Do not dispose of this product as unsorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical mmm 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 66 Chapter 6 Maintaining the Electrocardiograph Welch Allyn CP 100 Electrocardiograph 67 Troubleshooting Problem Solving Suggestions ees 68 Limited Warranty a ions dae RR mue ee eee tace Be dela ae 71 e Ige lgs m eee makina MAR PG Ea 72 68 Chapter7 Troubleshooting Problem Solving Suggestions This section includes several tables e Lead quality problems Table 2 on page 68 e System failure problems Table 3 on page 69 e System messages Table 4 on page 70 Welch Allyn CP 100 Electrocardiograph If you try these suggestions and still have problems contact Technical Support For phone numbers see page ii Table 2 Lead Quality Problems Condition Causes Actions A dot is flashing on the Lead Status Electrode contact may be poor e Reattach the lead e screen OR Lead off information is displayed on the Screen OR One or more leads prints as a square Wave jar e E e A lead may
17. as connecting the patient cable or performing an ECG test appear in the corresponding sections of the manual Caution statements indicate conditions or practices that could damage the equipment or other property A Caution When removing the electrocardiograph from storage allow it to thermally stabilize to surrounding environmental conditions before using it Caution To prevent possible damage to the keypad do not use sharp or hard objects to press keys Only use fingertips Caution Do not expose the patient cable to strong ultra violet radiation 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 or stepped on If the cable s impedance is altered measurements might no longer be accurate and repair might be necessary Caution Using the equipotential terminal for anything but grounding purposes may contribute to damage of the device Caution Use only parts and accessories supplied with the device and available through Welch Allyn The use of accessories other than those specified may result in degraded performance of this device Caution Portable and mobile RF communications equipment can affect the performance of the electrocardiograph Caution The electrocardiograph meets the Class A requirements of IEC 60601 1 2 2000 regarding incidenta
18. be loose Note Square waves may indicate that the electrocardiograph is inoperative but they are more likely to indicate loose leads Replace the electrode Verify that the electrode area has been properly prepared shaved cleaned with alcohol or acetone allowed to dry Verify that electrodes have been properly stored and handled Wandering baseline an upward and e Electrodes that are dirty corroded e Clean skin with alcohol or acetone downward fluctuation of the waveforms loose or positioned on a bony area e Reposition or replace electrodes e Insufficient or dried electrode gel e Help patient relax e Oily skin or body lotions e f wandering baseline persists turn the baseline e Rising and falling of chest during rapid ilter on See Adjust Baseline Filter on or apprehensive breathing page 55 Muscle tremor interference random e Patient is uncomfortable tense e Help patient get comfortable nervous e Check all electrode contacts irregular voltage superimposed on the waveforms May resemble or coincide with AC interference bebe d boo e Patient is cold and shivering e Exam bed is too narrow or short to comfortably support arms and legs e Armor leg electrode straps are too tight f interference persists turn the muscle tremor ilter on See Adjust Muscle Filter on page 55 If interference still persists the problem is probably electrical in nature See the following suggestions for
19. f the Z wire is broken or dark replace the fuse See Replacing the Battery DC Fuse on page 63 Figure 40 Battery Fuse Plugged In w Z wire 62 Chapter 6 Maintaining the Electrocardiograph Welch Allyn CP 100 Electrocardiograph 6 Unplug the two battery connectors See Figure 41 You may need to pull hard Use pliers gently if necessary Figure 41 Battery Connectors 7 Connect a new battery by matching connector sizes Do not force connectors to mismatch 8 Carefully tuck in all cables Place the battery into the battery compartment Fold the strap so that it will not stick out when you replace the battery door See Figure 42 Figure 42 Folding the Battery Strap Directions for Use Chapter 6 Maintaining the Electrocardiograph 63 Replace the battery door and screws Turn the electrocardiograph rightside up It turns on automatically and displays a prompt to enter date and time Enter the date and time The electrocardiograph is ready to use Discard the old battery appropriately e n the USA call 1 800 SAV LEAD for instructions on how to recycle it e International users contact your local authorities concerning recycling Replacing the Battery DC Fuse If the battery DC fuse requires replacing as described in Step 5 on page 61 follow these steps For the fuse value see Fuses on page 73 1 Remove and di
20. type 10 amp 32 V rating Bussman ATC 10 or equivalent Standard Cabrera Lead acid gel 6 volt 5 AH Prints up to 100 continuous ECGs per charge 12 hour recharging 14 Appendix A Specifications Welch Allyn CP 100 Electrocardiograph Item Continued Specification Continued Filters Safety EMC and regulatory compliance Standard connectivity Connectivity with electronic medical records Electrodes Cables and wires Environmental operating conditions Temperature Relative humidity Altitude Environmental storage conditions Temperature Relative humidity Altitude Protection against electric shock Protection against ingress of water per IEC 60529 Mode of operation 0 5 Hz high performance baseline filter 35 Hz muscle tremor filter AC interference filter 50 Hz or 60 Hz ANSI AAMI EC11 UL60601 1 CAN CSA C22 2 No 601 1 IEC EN 60601 1 CAN CSA C22 2 No 601 1 1 IEC EN 60601 1 1 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 2 25 CAN CSA C22 2 No 601 2 51 IEC EN 60601 2 51 Com port for USB cables or removable USB storage devices gt 64 MB 2 GB SD memory card slot for use with cards gt 64 MB 2 GB Supported through the Welch Allyn CardioPerfect workstation software Rigorously tested for conductivity adhesion and hypoallergenic qualities and exceed all AAMI standards Meet or exceed IEC 6
21. 0601 410 C to 40 C 50 F to 104 F 15 95 noncondensing 700 1060 hPa 20 C to 49 C 4 F to 120 F 15 9596 noncondensing 30 7096 for printing 500 1060 hPa Class internally powered Type CF IPXO Continuous Per AAMI EC11 1991 R 2001 Diagnostic Electrocardiographic Devices Section 3 1 2 1 Disclosure of cautionary information performance characteristics paragraph c 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 amp 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 Because of the sampling characteristics and the asynchronism between sample rate and signal rate digital ECG systems such as the CP 100 and CP 200 may produce a noticeable modulating effect from one cycle to the next particularly in pediatric recordings This phenomenon is not physiologic Specifications are subject to change without notice 15 EMC Guidance and Manufacturer s Declarations Table 5 Electromagnetic Emissions The CP 100 electrocardiograph is intended for use in the electromagnetic environment specified below The customer or user of the CP 100 electrocardiograph should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF em
22. 100 Electrocardiograph System Message Problems Actions Insufficient battery power to begin Please connect AC power and try again Battery low or bad e Recharge the battery See Recharging a Fully Discharged Battery on page 60 e Replace battery See Replacing the Battery on page 61 Insufficient space available Not enough space on memory card or removable USB storage device e Delete some tests from the card or USB storage device at a PC e Use a different card or USB storage device Memory card error Problem writing to memory card or removable USB storage device e Verify that the write protect tab is in the unprotected position Reseat the card in its slot Use a different card or USB storage device Qut Of Paper Paper Jam Printer is out of paper e Printer door is open Paper was loaded incorrectly e Load paper See Loading the Thermal Chart Paper on page 21 e Close the printer door See Loading the Thermal Chart Paper on page 21 Reload the paper See Loading the Thermal Chart Paper on page 21 Powering down Low battery Recharge the battery See Recharging a Fully Discharged Battery on page 60 Problem loading the following settings System lt ECG gt Using default settings Problem loading your settings at startup May indicate memory problems Contact Technical Support For phone numbers
23. 48 rhythm ECG testing 54 formats See Auto ECGs report settings Rhythm ECGs report settings frequency range 33 34 73 fuses 61 63 64 G gain settings changing 55 default choosing 40 as printed on report 33 34 H hardware set up 19 23 height unit setting 27 help getting 18 history list choosing from 37 Hodges OTc method 39 IEC electrode labels C1 C2 C3 etc 40 45 46 indications for use 3 inspection procedures 58 intended use 2 Welch Allyn CP 100 Electrocardiograph Internet address ii interpretation of ECGs automatic about 2 3 5 confirming 36 ordering 6 as printed on reports 33 34 settings for Auto Reports 36 K keyboard 9 73 L language setting 27 leads 10 lead wires vs 12 waveform leads 79 adjusting waveforms 55 arrangements in reports 35 configurations standard or Cabrera 40 73 electrode placement 45 46 ordering 6 print timing simultaneous or sequential 39 troubleshooting problems with 68 See also patient cable electrodes augmented lead set Lead Status screen 47 M ain menu 10 ains See AC aintenance tasks 57 65 easurements See extended measurements edication list choosing from 37 emory card for communication with CardioPerfect workstation 3 problems writing to 70 sending tests to 51 slot location 8 specification 74 used with USB storage device 3 menus navigating through 11 menu trees ECG setup 32 system set
24. 9 on page 61 100660 1 Dust cover 701586 1 Carts e Utility cart 08265 0000 1 e Office cart Figure 1 on page 5 401393 1 Hospital cart Figure 2 on page 5 401394 1 e Cable arm amp shelf option page 5 401161 1 Interpretation upgrade option 100623 1 Product information e Electrode placement wall poster 71300 0000 1 e CP 100 12 Lead Resting Electrocardiograph Directions 708794 1 for Use e CP 100 product information multi language CD 401150 1 Directions for Use Chapter 1 Introduction 7 Controls Indicators and Connectors This section describes the controls indicators and connectors that are part of the electrocardiograph Figure 3 Top Keyboard See Figure 1 on page 9 AC power inlet Equipotential stud AC fuses Chapter 1 Introduction Figure 5 Right Side Welch Allyn CP 100 Electrocardiograph Com port B USB SD memory card 10101 slot SD Figure 6 Front Not functional Reset button Figure 7 Com port A for patient cable G gt Left Side Paper tray latch Directions for Use Table 1 Keyboard Chapter 1 Introduction 9 Function On Off Backspace Menu Auto ECG Rhythm ECG Navigation arrows Enter Stop Cancel Space Control Shift Help Tab Green LED See Power
25. Allyn CP 100 Electrocardiograph Recording an Auto ECG An Auto ECG is a report typically showing a 10 second acquisition of 12 leads of ECG information combined with patient data interpretation and measurements matrix To learn how to set up the Auto ECG report format see About Auto ECG Reports on page 33 As shown in the following diagram there are the two types of Auto ECG normal and stat For details see these procedures e Recording a Normal Auto ECG on page 49 e Recording a Stat Auto ECG on page 53 Figure 31 Auto ECG Testing Process Diagram Normal Stat Press quickly Press and hold i Enter patient data Auto Report prints V Auto ECG Post Print screen Directions for Use Recording a Normal Auto ECG Chapter 5 Performing ECG Tests 49 For a normal Auto ECG you enter patient data and do other optional tasks before printing as shown in Figure 31 on page 48 To Record a Normal Auto ECG 1 Press the Auto ECG key En quickly Do not hold it down or a stat ECG would begin The following screen appears Figure 32 Enter New Patient Screen 9 17AM Oct 16 08 Enter New Patient Patient ID A LastName 9 HA First Name Birth Date MM DD YYYY Weight E Ib Height ft in Gender vl Use up and down arrows to change fields 2 Enter the patient dat
26. CP 100 12 Lead Resting Electrocardiograph Lor E por 2000 caos QU a Que qu eg y Directions for Use WelchAllyn Advancing Frontline Care ii Welch Allyn CP 100 Electrocardiograph Copyright 2008 Welch Allyn 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 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 Welch Allyn is a registered trademark of Welch Allyn Inc and CP 100 and CardioPerfect are trademarks of Welch Allyn Inc SD is a trademark of Toshiba Software in this product is copyright Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a
27. G reports Audio Beeper On or off When on beeps to indicate errors such as incorrect input improper external connections or a printer error Beeps may also indicate a low battery Increase Contrast Each time you select this choice the display contrast immediately increases until you reach maximum contrast Decrease Contrast Each time you select this choice the display contrast immediately decreases until you reach minimum contrast Contact Information Your office Enter up to 40 characters This information will appear on the accessories Help page 28 Chapter 3 Reviewing the System Settings Welch Allyn CP 100 Electrocardiograph Setting Continued Description Continued Printer Select Internal or External When External is selected and when an external printer is connected and turned on reports will print to that printer For details see Connecting an External USB Printer Optional on page 24 CAPS Lock On or off Works just like a standard CAPS Lock key Directions for Use Chapter 3 Reviewing the System Settings Reviewing the Device Information 1 Press the Menu key 2 Choose System Settings gt Device Info The following screen appears Figure 19 Device Info Screen MI 9 17AM Oct 16 08 Device Info 1 About 2 Print Settings 3 Manage Settings 4 Enable Options 5 Upgrade Software 6 Service Info 0 Previous Menu 3 Select the desired item 29 Item
28. S 32 About Auto ECG Reports 0 0 00 ees 33 Reviewing the Format Settings for Auto Reports 35 Reviewing the Interpretation and Copy Settings for Auto Reports 36 Reviewing the Patient Data Fields Available 37 Reviewing the Auto Report Settings llli eee 39 Reviewing the Miscellaneous ECG Settings 00 AA 40 Turning the Augmented Pediatric Lead Set On and Of 41 5 P rtormirnd ECG Teste acp PRA Race eei Ce td ee 43 Connecting the Leads to the Patient ai errar erni eo ni eE OE DE a 44 Recordingian Auto ECG As a lined este gy ale ES ER Saeed BANG EREA 48 Recording a Normal Auto ECG 2 2 ee 49 Recording a Stat Auto ECG o ee 53 Recording a Rhythm ECG iu ree ate er RACER Ded usus 54 Adjusting the ECG Waveforms 0 20 y an d a eee 55 6 Maintaining the Electrocardiograph 57 Inspecting the Equipment o 58 Gleaning the Equipment usce ep REA penu de dedere 58 Testing the Equipment 0 0 e rs 59 Recharging a Fully Discharged Battery 020000 0c eee eee 60 Replacingathex Battery it sen def ip o uf LM A peel nad IP gioi tnd A da 61 Replacing the Battery DC Fuse 0 eee 63 Replacing they AC FUSESH ad cse tue de ob ba t he of epa den pd eds 64 Stonn thE Equipe Ese soe tt rc e aaa PH ds 65 Discarding the Equipment vv sce ad dad id 65 F TrOMDIEeSHOO UNO e tenet EO RR Erunt iaa
29. a For details about these data fields including how to choose which fields display and print see Reviewing the Patient Data Fields Available on page 37 3 When finished select Done at the end of the list The Auto ECG Acquisition screen appears See Figure 33 on page 50 50 Chapter5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Figure 33 Auto ECG Acquisition Screen Doe Jane 9 17AM Oct 16 08 Auto ECG Acquisition HR 75 Printing Report nn MN The electrocardiograph displays messages here when it is doing the following Gain 10 mm mV ba Collecting data Speed 25 mm s Analyzing data Baseline Filter ON Printing the report Muscle Filter ON 4 If prompted choose whether to wait for the electrocardiograph to acquire 10 seconds of filtered processed data before printing If you override the wait time and print the available data immediately be aware that the printed data will be insufficient in quality or quantity or both The report prints Note If a red stripe appears along the edge of your report replace the paper See Loading the Thermal Chart Paper on page 21 After printing the Auto ECG Post Print screen appears Figure 34 on page 51 Directions for Use Chapter 5 Performing ECG Tests Figure 34 Auto ECG Post Print Screen Doe Jane MI 9 17AM Oct 16 08 Auto ECG Post Print 1 Exit 2 Print Copy 3 Repeat Test 4 Export Test 5 Select the desir
30. ation Indicates whether the report has been reviewed and accepted by a qualified physician electrocardiogram ECG A record of the electrical currents associated with heart muscle activity Sometimes called EKG for the German term Elektrokardiogramm See also Auto ECG Rhythm ECG electrocardiograph An instrument used to create electrocardiograms ECGs extended measurements Values for several common parameters such as O R and S amplitude and ST values The amplitudes are expressed in microvolts The durations are expressed in milliseconds The measurements cannot be edited Printed on a separate page if enabled IEC An abbreviation for nternational Electrotechnical Commission The IEC electrode labeling scheme is most commonly used in Europe lead 1 An electrocardiograph wire connected to an electrode which is attached to a patient s skin There are 10 lead wires 2 A waveform that represents ECG data from a particular view of the heart The data from the 10 lead wires is converted into 12 waveforms also called leads II III aVR etc MEANS An acronym for modular ECG analysis system The optional MEANS interpretation algorithm developed by the University of Rotterdam Netherlands provides automatic analysis of ECG tests Also available in pediatric version PEDMEANS PEDMEANS See MEANS Power Save A user selectable feature that automatically turns the electrocardiograph off after several idle minutes 80 Glos
31. cardiac patients Before using the CP 100 electrocardiograph for clinical applications or before setting up configuring troubleshooting or servicing the electrocardiograph you must read and understand this manual and all other information accompanying the electrocardiograph and related options or accessories Product Overview The Welch Allyn CP 100 electrocardiograph features a full alohanumeric keyboard an LCD display full size userprogrammable reports and the ability to operate on either battery or AC power ECG tests sent to a memory card or removable USB storage device are compatible with the Welch Allyn CardioPerfect workstation which in turn can connect with other electronic patient information systems such as billing and medical records For details see the following sections e Standard Features amp Benefits on page 3 e Options on page 5 e Specifications on page 73 Intended Use The Welch Allyn electrocardiography and spirometry products subject devices are intended for use by trained operators in health facilities The subject devices provide the following diagnostic functions e Acquiring and printing ECG waveforms using ECG front end modules patient cables and associated accessories that provide signal acquisition for up to twelve 12 leads of patient ECG waveforms through surface electrodes adhered to the body e Using optional algorithms to generate measurements data presentations
32. choices Blank Caucasian Black Hispanic Asian Unknown Yes or no If yes this field is enabled During data entry choose one item from the list of patient medications Yes or no If yes this field is enabled During data entry choose one item from the list of patient clinical conditions 38 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 100 Electrocardiograph Field Continued Description Continued BP Yes or no If yes this field is enabled for entering blood pressure in standard format Comments Yes or no If yes this field is enabled for entering comments Directions for Use Chapter 4 Reviewing the ECG Settings 39 Reviewing the Auto Report Settings 1 Press the Menu key 2 Choose ECG Settings gt Auto Report Settings The following screen appears Figure 25 Auto Report Settings Screen for ECG Settings Auto Report Settings y 1 Baseline Centering 2 Lead Timing 3 Artifact Report 4 QTc Method 0 Previous Menu MF 9 17AM Oct 16 08 3 Change any desired settings Setting Description Baseline Centering Lead Timing Artifact Report QTc Method On or off When on aligns the isolectric line of all leads Simultaneous or sequential Simultaneous prints ECG data that was captured simultaneously for all lead groups Sequential prints ECG data that was captured at sequential intervals for each lead group in turn On or of
33. columns 1 rhythm lead e 3x4 3R 3 rows x 4 columns 3 rhythm leads e 6x2 6 rows x 2 columns e 12x1 12 rows x 1 column e 6x2 50 mm s 6 rows x 2 columns 50 mm s e 6x2 Ext 6 rows x 2 columns extended printouts two pages 20 seconds of ECG data e 2x6 1R 2 rows x 6 columns 1 rhythm lead e 6x2 1R 6 rows x 2 columns 1 rhythm lead e No Print No report prints Rhythm Lead 1 Rhythm lead to print at the bottom of all R reports Rhythm Lead 2 Second rhythm lead to print at the bottom of 3x4 3R reports Rhythm Lead 3 Third rhythm lead to print at the bottom of 3x4 3R reports Extended On or off When on an additional page prints with the report Extended measurements Measurements include the values for several common parameters such as Q R and S amplitude and ST values The amplitudes are expressed in microvolts The durations are expressed in milliseconds The measurements cannot be edited Average Cycles If desired an additional page prints with the report Average cycles show the dominant waveforms for all 12 leads 3x4 50 mm s 3R 3 rows x 4 columns 3 rhythm leads 50 mm s 6x2 50 mm s 6R 6 rows x 2 columns 6 rhythm leads 50 mm s e No Print Average cycles page does not print 36 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 100 Electrocardiograph Reviewing the Interpretation and Copy Settings for Auto Reports 1 2 3 Press the Menu key Choose ECG Settings gt Edit Auto Report gt Inter
34. cording a Stat Auto ECG A stat Auto ECG is an immediate printout Stat mode bypasses patient data entry as shown in Figure 31 on page 48 A temporary ID number is assigned to the patient to identify stat tests To Record a Stat Auto ECG 1 Press and hold the Auto ECG key Ew The electrocardiograph begins acquiring ECG data After it has acquired 10 seconds of quality data it prints a report 2 Goto Step 4 on page 50 54 Chapter5 Performing ECG Tests Recording a Rhythm ECG Welch Allyn CP 100 Electrocardiograph 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 Figure 36 Rhythm ECG Testing Process Diagram TT ee Optional Adjust Printing begins t gt nd To Record a Rhythm ECG 1 Press the Rhythm ECG key E Printing begins and the following screen appears Figure 37 Rhythm ECG Screen Rhythm ECG HR 75 1 Change Leads Lull 2 Adjust Gain 10 mm mV 3 Adjust Baseline Filter ON 4 Adjust Muscle Filter ON 5 Adjust Speed 25 mm s 2 Optional Adjust the waveforms See Adjusting the ECG Waveforms on page 55 3 Press or HA to stop printing 0 6 The Ready screen appears if all leads are connected to the patient Directions for Use Chapter 5 Performing ECG Tests 55 Adjusting the ECG Waveforms T
35. ctrocardiograph can run on AC or battery power A WARNING To ensure that electrical safety is maintained when using AC power the device must be plugged into a hospital grade outlet WARNING Where the integrity of external protective earth conductor arrangement is in doubt use battery power Caution Medical electrical equipment needs special precautions regarding EMC AN and must be installed and used according to the information provided in EMC Guidance and Manufacturer s Declarations on page 75 To Connect to AC Power Plug one end of the power cord into the electrocardiograph s AC power inlet Plug the other end into an AC outlet The green LED on the keyboard lights up indicating that power is connected See Figure 17 To Keep the Battery Charged Leave the electrocardiograph connected to AC power whenever possible Battery charge status is indicated on the screen by an icon HF Whenever the battery is charging and is not yet fully charged this icon appears F5 For maximum battery performance as often as possible leave the electrocardiograph plugged in until you see the fully charged icon MEE When the charge gets low the icon flashes When the charge gets too low to operate a warning message appears and the electrocardiograph beeps every 15 seconds for 1 minute then it turns off For more see Recharging a Fully Discharged Battery on page 60 Figure 17 AC Power Inlet and Green LED
36. dcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CP 100 electrocardiograph is used exceeds the applicable RF compliance level above the electrocardiograph should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the electrocardiograph b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 78 Appendix B EMC Guidance and Manufacturer s Declarations Welch Allyn CP 100 Electrocardiograph Table 8 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CP 100 Electrocardiograph The CP 100 electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the CP 100 electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CP 100 electrocardiograph as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Max Output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Power of
37. e of defective materials components or workmanship and the warranty claim is made within the warranty period described above Welch Allyn will at its discretion repair or replace the defective 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 You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn s designated service center for repair Contact Welch Allyn Technical Support For phone numbers see page ii THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILTY AND FITNESS FOR A PARTICULAR PURPOSE WELCH ALLYN S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY 72 Chapter7 Troubleshooting Welch Allyn CP 100 Electrocardiograph service Policy All repairs on products under warranty must be performed or approved by Welch Allyn Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall exclusively be performed by Welch Allyn certified service personnel If the product fails to function proper
38. ed item 51 Item Effect Exit The Ready screen appears if all leads are connected to the patient Print Copy A copy of the test prints To learn how to print multiple copies of all tests automatically see Reviewing the Interpretation and Copy Settings for Auto Reports on page 36 Repeat Test The following screen appears Figure 35 Auto ECG Repeat Test Screen Doe Jane HL 9 17AM Oct 16 08 Auto ECG Repeat Test 1 Adjust Gain 10 mm mV 2 Adjust Baseline Filter ON 3 Adjust Muscle Filter ON 4 Print ECG 1 Optional Adjust the waveforms See Adjusting the ECG Waveforms on page 55 2 Choose Print ECG A new report prints Export Test Sends the test to the memory card An SD memory card or removable USB storage device must be in place 52 Chapter5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph A Caution The requirements of AAMI EC11 Section 3 2 72 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 These requirements are unaffected by any other combination of filters turned on or off Measurements performed by the optional interpretation algorithm are unaffected by any filter selections Directions for Use Chapter 5 Performing ECG Tests 53 Re
39. ee eee e eee tees 22 Verifying Proper Operation 0c cece eee eens 23 Connecting an External USB Printer Optional 24 19 20 Chapter2 Setting Up the Electrocardiograph Welch Allyn CP 100 Electrocardiograph Inspecting the Electrocardiograph 1 Look for obvious signs of shipping damage If you find any damage contact Technical Support For phone numbers see page ii Verify that you have received all appropriate options and accessories See Options on page 5 and Accessories on page 6 Connecting the Patient Cable A WARNING Conductive parts of the patient cable electrodes and associated 1 connections of defibrillation proof Type CF applied parts including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground WARNING To avoid injury to the patient or damage to the device never plug patient leads into any other device or wall outlet Insert all leads into their proper positions as labeled on the connectors Insert connectors fully so that no part of the metal ring remains exposed For example see Figure 12 To see the whole patient cable with all leads inserted see Figure 11 on page 12 WARNING Failure to insert all connectors fully may result in a loss of energy being delivered to the patient during defibrillation and damage to the patient cable itself For other warnings related to defibril
40. emory card slot Alternating current Battery is charging Ee Dangerous voltage AC fuse replacement information ja Do not reuse Do not dispose of this product as unsorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the 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 aL e gt 10101 Help Backspace Shift Menu Stop Cancel Com port A for patient cable Battery charge level Battery is charged Direct current Ground equipotential Sealed lead acid battery Recycle Defibrillation proof Type CF applied parts While the electrocardiograph is safety rated CF for direct cardiac contact it is not intended to be connected directly to the patient s heart Only surface contact with the patient s skin is intended Com port B USB Directions for Use Chapter 1 Introduction 15 Using the Electrocardiograph Safely Before using or servicing the electrocardiograph you must read and understand the following safety related information General Warnings The following warning statements apply to electrocardiograph use in general Warning statements that ap
41. f When on the electrocardiograph automatically prints an artifact report with the Auto ECG report whenever artifact is detected and you override the Waiting for 10 seconds of quality data message This report a 12x1 format with all filters disabled shows the leads with artifact so that you can remedy the problem The normal Auto ECG report with filters enabled might mask some of the artifact issues Bazett or Hodges Computation method of correcting the waveform s OT interval based on the heart rate The corrected number expressed in milliseconds is called the OTc interval This setting affects only the OTc interval displayed in the ECG measurements portion of the ECG report 40 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 100 Electrocardiograph Reviewing the Miscellaneous ECG Settings 1 Press the Menu key 2 Choose ECG Settings gt Miscellaneous The following screen appears Figure 26 Miscellaneous Screen for ECG Settings Miscellaneous y 1 Lead Configuration 2 Electrode Labels 3 Default Gain Setting 4 Default Baseline Filter 5 Default Muscle Filter 6 Mains Filter 0 Previous Menu MF 9 17AM Oct 16 08 These three default settings gain baseline filter and muscle filter determine the values used every time you begin a new test even if these values have been temporarily changed during ECG testing 3 Change any desired settings Setting Description Lead Config
42. gs for Auto Reports on page 36 See Reviewing the Format Settings for Auto Reports on page 35 See Reviewing the Format Settings for Auto Reports on page 35 See also Reviewing the Device Information on page 29 See Device ID on page 27 See Practice ID on page 27 See Set Date Time on page 27 See Mains Filter on page 40 Lower limit baseline filter on 0 5 off 0 3 Upper limit muscle filter on 35 off 150 See Adjust Baseline Filter on page 55 and Adjust Muscle Filter on page 55 See Adjust Gain on page 55 See Adjust Speed on page 55 Amplitude reference represents the current height of a one millivolt signal Is adjusted for the selected gain 5 mm mV 0 5 x 10 mm mV 2 1 x 20 mm mV 22 x Directions for Use Chapter 4 Reviewing the ECG Settings 35 Reviewing the Format Settings for Auto Reports 1 2 3 Press the Menu key Choose ECG Settings gt Edit Auto Report gt Format The following screen appears Figure 22 Auto Report Format Screen MI 9 17AM Oct 16 08 Format 1 Lead Arrangement 2 Rhythm Lead 1 3 Rhythm Lead 2 4 Rhythm Lead 3 5 Extended Measurements 6 Average Cycles 0 Previous Menu Change any desired settings For a report example see Figure 21 on page 33 Setting Description Lead Arrangement Arrangement of the leads on the report e 3x4 3 rows x 4 columns e 3x4 41R 3 rows x 4
43. ing the Electrocardiograph on page 22 Deletes the character to the left of the cursor See About the Main Menu on page 10 Begins Auto ECGs normal and stat See Recording an Auto ECG on page 48 Begins a Rhythm ECG See Recording a Rhythm ECG on page 54 See Moving Through the Menus on page 11 See Moving Through the Menus on page 11 Stops any current activity See Moving Through the Menus on page 11 Enters a space Applicable only for keyboards with characters above certain keys To enter a character above a key hold the Ctrl key while pressing that key To capitalize the character hold Shift Ctrl while pressing the key Capitalizes letters Also enters symbols 96 etc To enter a symbol hold the Shift key while pressing a number key See Getting Help on page 18 Moves through the data entry fields Lights up when the electrocardiograph is connected to AC power 10 Chapter 1 Introduction Welch Allyn CP 100 Electrocardiograph About the Main Menu The main menu appears when you press the Menu key Figure 8 Main Menu MI 9 17AM Oct 16 08 Main Menu 1 ECG Settings 2 System Settings 0 Exit Submenu Purpose Procedure ECG Settings Review or change ECG settings Auto See Reviewing the ECG Settings on Report format Rhythm Report format and page 31 so on System Settings Review or change system settings device See Reviewing the System Settings on configura
44. issions Group 1 The CP 100 electrocardiograph uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby CISPR 11 electronic equipment RF emissions Class A The CP 100 electrocardiograph is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network CISPR 11 that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 16 Appendix B EMC Guidance and Manufacturer s Declarations Table 6 Electromagnetic Immunity The CP 100 electrocardiograph is intended for use in electrocardiograph should assure that it is used in such an environment Welch Allyn CP 100 Electrocardiograph the electromagnetic environment specified below The customer or user of the CP 100 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact x 8 kV air 6 kV contact x 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input
45. l emission of radio frequency interference As such it is suitable for use in commercial grade electrical environments If the electrocardiograph is used in residential grade electrical environments and you experience incidental interference with other equipment that uses radio frequency signals to operate minimize the interference as described under EMC Guidance and Manufacturer s Declarations on page 75 Caution Other medical equipment including but not limited to defibrillators ultrasound machines pacemakers and other stimulators may be used simultaneously with the electrocardiograph However such devices may disturb the electrocardiograph signal Caution The power cord must be disconnected from AC power before cleaning maintaining or servicing 18 Chapter 1 Introduction Welch Allyn CP 100 Electrocardiograph Getting Help You can get help with the electrocardiograph in a variety of ways beyond this manual Press the Help key 2 from the Ready screen or Lead Status screen for a list of topics available to print Review the other information that came with the electrocardiograph For list see Product information on page 6 Contact Welch Allyn For phone numbers see page ii Setting Up the Electrocardiograph Inspecting the Electrocardiograph o 20 Connecting the Patient Cable lille 20 Loading the Thermal Chart Paper eee eee eee eee 21 Powering the Electrocardiograph e
46. lation see page 16 Plug the patient cable into the port on the front of the electrocardiograph See Figure 13 Figure 12 Inserting the Leads Figure 13 Plugging in the Connector Directions for Use Chapter2 Setting Up the Electrocardiograph 21 Loading the Thermal Chart Paper 1 Squeeze the latch Pull the paper door to the left See Figure 14 If any paper remains in the tray remove it 2 Remove the outer packaging including the cardboard bottom from a new pack of paper Pull the top sheet back so that the paper s grid side faces up and the Welch Allyn name is on the bottom of the paper 3 Slide the paper into the tray See Figure 15 If humidity is high remove up to 10 sheets so that the paper fits properly 4 Lay the top sheet over the paper door Push the door to the right until it clicks See Figure 16 Figure 14 Opening the Paper Door Figure 15 Loading the Paper Paper tray KOON KN SSI LESS ZEN KAKA LBS OS ARS T KIA HAE SRSA 1 72 SOS GEEZ SAS Figure 16 Closing the Paper Door Tips for handling thermal paper Tear bar e Store in a cool dry dark place e Avoid exposure to bright light or UV sources e Avoid exposure to solvents adhesives or cleaning fluids e Do not store with vinyls plastics or shrink wraps 22 Chapter2 Setting Up the Electrocardiograph Welch Allyn CP 100 Electrocardiograph Powering the Electrocardiograph The ele
47. le and Leads Chest leads Left arm lead Electrocardiograph connector Right arm lead Right leg lead Directions for Use Chapter 1 Introduction 13 Symbols The symbols illustrated on the following pages may appear on the electrocardiograph on the packaging on the shipping container or in this manual Documentation Symbols WARNING Indicates conditions or practices that could lead to illness injury or death Caution In this manual indicates conditions or practices that could damage the equipment or other property Caution On the product means Consult accompanying documentation gt gt Pb Shipping Storing and Environment Symbols This end up e Keep dry gt Fragile 95 Relative humidity limit HAD 77T Temperature limits 4 Altitude limits 500 1060 hPa a 20 Certification Symbols Complies with applicable U S and Canadian f medical safety standards C Meets essential requirements of European 0297 Medical Device Directive 93 42 EEC C Liste Us 74227 European Regulatory Manager Australian registered importer N344 14 Chapter 1 Introduction Welch Allyn CP 100 Electrocardiograph Operation Symbols For details on the keys see Figure 1 on page 9 c ES t E Ji E Ix epep E On standby off 7 ec Navigation arrows 0 Enter t Auto ECG Rhythm ECG SE x SD m
48. line on same horizontal level as V4 purple purple F LA L Just above left wrist on inside of arm black yellow G LL F Just above left ankle red green H RL N Just above right ankle green black l RA R Just above right wrist on inside of arm white red J V3R C3R Mirror position to standard V3 placement with respect to the mid green green sternal line Directions for Use 4 5 7 Chapter 5 Performing ECG Tests 47 If the electrocardiograph s display is blank press 0 If prompted to select a lead set type select Standard or Augmented For a description of the augmented pediatric lead set see page 4 If the Lead Status screen appears as shown here reattach any leads that are flashing Figure 29 Lead Status Screen MM 9 17AM Oct 16 08 Lead Status Check lead C1 C2 The term Artifact might also appear on this screen To eliminate artifact you might need to re prep the patient use fresh electrodes or minimize patient motion during the recording The most common ECG problems are poor electrode contact and loose leads When all leads have been connected for several seconds the following screen appears Figure 30 Ready Screen MI 9 17AM Oct 16 08 HR 75 Press Auto ECG or Rhythm ECG to start Go to the procedure for the type of ECG test you want to perform e Recording an Auto ECG on page 48 e Recording a Rhythm ECG on page 54 48 Chapter5 Performing ECG Tests Welch
49. lines IEC 61000 4 11 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode gt 95 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25 cycles gt 95 dip in 5 seconds 2 kV for power supply lines Not applicable 1 kV differential mode 2 kV common mode gt 95 dip in 0 5 cycle 6096 dip in 5 cycles 3096 dip for 25 cycles gt 95 dip in 5 seconds Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the CP 100 electrocardiograph requires continued operation during power mains interruptions it is recommended that the CP 100 electrocardiograph be powered from an uninterruptible power supply or battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Directions for Use Table 7 Electromagnetic Immunity Appendix B EMC Guidance and Manufacturer s Declarations 71 The CP 100 electrocardiograph is intended for use in the electromagnetic environment specified below The customer or user of the CP 100 electrocardiograph should assure that it is used in such a
50. ly or if you need assistance service or spare parts contact the nearest Welch Allyn Technical Support Center For phone numbers see page ii Before contacting Welch Allyn try to duplicate the problem and check all accessories to ensure that they are not causing the problem When calling please be prepared to provide e Product name and model number and complete description of the problem e Serial number of your product if applicable e Complete name address and phone number of your facility e For out of warranty repairs or spare parts orders a purchase order or credit card number e For parts orders the required spare or replacement part numbers If your product requires warranty extended warranty or non warranty repair service please call first the nearest Welch Allyn Technical Support Center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone avoiding potential unnecessary returns In case a return cannot be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA number as well as the appropriate return address An RMA number must be obtained prior to any return If you have to return goods for service follow these recommended packing instructions e Remove all hoses cables sensors power cords and ancillary products as appropriate before packing unless you suspect they are ass
51. may be fully discharged Note Regardless of the battery condition you can use the electrocardiograph whenever it is plugged in To Recharge the Battery 1 Plug the electrocardiograph into AC power 2 Verify that the green LED on the keyboard lights up See Figure 17 on page 22 If the LED does not light up go to Replacing the AC Fuses on page 64 3 Keep the electrocardiograph plugged in for 12 hours The first time you turn the electrocardiograph on after a full battery discharge you are prompted to reenter the date and time If the electrocardiograph still does not turn on when it is unplugged from AC power you may need to replace the battery or battery fuse See Replacing the Battery on page 61 or Replacing the Battery DC Fuse on page 63 Directions for Use Chapter 6 Maintaining the Electrocardiograph 61 Replacing the Battery If you have recharged the battery and the electrocardiograph still does not turn on when unplugged or if the battery loses its charge quickly replace the battery as follows For part number see Accessories on page 6 1 2 3 4 5 Unplug the electrocardiograph from AC power if connected Turn the electrocardiograph upside down Unscrew and remove the battery door See Figure 38 Lift out the battery See Figure 39 Figure 38 Removing the Battery Door Figure 39 Lifting Out the Battery Inspect the fuse See Figure 40 e fthe Z wire is intact go to Step 6 e
52. me 2 Middle Initial 3 Age Birthdate 4 Weight 5 Height 6 Gender 7 Race 8 Medication WF 9 17AM Oct 16 08 The Patient ID and Last Name fields always appear on the Enter New Patient screen as shown in Figure 32 on page 49 Since these two fields cannot be disabled they do not appear on this user selectable list 3 Change any desired settings Disabled items set to off or no neither display nor print Field Description First Name Middle Initial Age Birthdate Weight Height Gender Race Medication History Yes or no If yes this field is enabled Yes or no If yes this field is enabled Birthdate age or off Determines whether and how this data is labeled and entered If you ll be testing patients from 1 day through 17 years old select Birthdate for most accurate results If age is selected age will be entered in years and months Yes or no If yes this field is enabled for entering patients weight For instructions on changing the weight units kg or Ib see Reviewing the Device Configuration Settings on page 27 Yes or no If yes this field is enabled for entering patients height For instructions on changing the height units cm in or ft and in see Reviewing the Device Configuration Settings on page 27 Yes or no If yes this field is enabled Data entry choices Male Female or Unknown Yes or no If yes this field is enabled Data entry
53. n environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the CP 100 electrocardiograph including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 17 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 33 P 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 5 Note 1 At 80 MHz and 800 MHz the higher frequency range app les Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broa
54. o adjust the waveforms after printing an Auto ECG or while printing a rhythm ECG press an item s number key as needed until the desired choice appears Item Effect Change Leads available for Rhythm ECG only Cycles through the lead groups three at a time Adjust Gain Cycles through the gain settings in mm mV 5 10 20 AUTO changing the waveform size AUTO is available for Auto ECGs only not rhythm ECGs AUTO is usually the best setting but some waveforms may be easier to read on other settings To learn how to change the gain s default setting see Reviewing the Miscellaneous ECG Settings on page 40 a tbh fb 5 mm mV 10 mm mV 20 mm mV Adjust Baseline Filter Toggles between the two baseline filter settings on or off This filter reduces wandering baseline an upward and downward fluctuation of the waveforms It is preferable if possible to eliminate or reduce wandering baseline by addressing the causes as explained on page 68 To learn how to change the filter s default setting see Reviewing the Miscellaneous ECG Settings on page 40 Caution You cannot perform ST segment analysis on waveforms that were recorded with the muscle filter turned on For details see the caution on page 52 EU MUS Wandering baseline Adjust Muscle Filter Toggles between the two muscle filter settings on or off This filter reduces muscle tremor interference random irregular voltage superimposed on the
55. o allow all traces of alcohol to evaporate before turning the electrocardiograph back on Directions for Use Chapter 6 Maintaining the Electrocardiograph 59 Testing the Equipment WARNING Only qualified service personnel should perform leakage current tests Whenever the electrocardiograph is serviced or problems are suspected Welch Allyn recommends the following test procedures 1 Verify continued electrical safety of the device using IEC 60601 1 or ANSI AAMI ES1 methods and limits Test for the following Patient leakage current Chassis leakage current Earth leakage current Dielectric strength AC and patient circuits Verify that the electrocardiograph is working properly using an ECG simulator to acquire and print a standard 12 lead ECG of known amplitude e Printing should be dark and even across the page e There should be no evidence of print head dot failure no printing breaks forming horizontal streaks e Paper should move smoothly and consistently during printing e Waveforms should appear normal with proper amplitude and without distortion or excessive noise e Paper should stop with perforations near the tear bar indicating proper cue sensor operation For tearbar location see Figure 16 on page 21 60 Chapter 6 Maintaining the Electrocardiograph Welch Allyn CP 100 Electrocardiograph Recharging a Fully Discharged Battery If the electrocardiograph does not turn on when unplugged the battery
56. ociated with the problem e Wherever possible use the original shipping carton and packing materials e Include a packing list and the Welch Allyn Return Material Authorization RMA number It is recommended that all returned goods be insured Claims for loss or damage to the product must be initiated by the sender 73 A Specifications Item Specification Dimensions 16 2 in 41 1 cm 6 2 in 15 7 cm 15 6 in 39 7 cm Weight 11 6 Ib 5 3 kg Keyboard type Elastomer keypad with complete alphanumeric keys Paper type 825 x 11 inches 21 x 28 cm Z fold thermal paper 200 sheets Thermal printer internal USB printer external Thermal paper speeds Gain settings Auto ECGs Rhythm ECGs Report print formats Auto ECGs Rhythm ECGs Average cycles Frequency range Digital sampling rate Pacemaker detection Power requirement Fuses AC DC battery fuse Lead configurations Rechargeable battery Computer controlled dot array 8 dots mm Inkjet or laser printer that supports PCL printer control language 10 25 50 mm s 5 10 20 mm mV AUTO 5 10 20 mm mV 3x4 3x4 1R 3x4 3R 6x2 12x1 6x2 50 mm s 6x2 Ext 2x6 1R 6x2 1R 3 leads at a time 3x4 50 mm s 3R 6x2 50 mm s 6R 0 3 to 150 Hz gt 1 000 samples second channel ANSI AAMI EC11 Universal AC power supply 100 240 V 50 60 Hz 2 2 A maximum Time delay type 2 amp 250 V rating Littlefuse 0215002 or equivalent Fast acting
57. on Causes Actions Won t turn on when plugged into AC power e Faulty AC power connection e Blown AC fuses e No AC power e Check the AC power source e Check the AC fuses See Replacing the AC Fuses on page 64 Won t turn on when unplugged from AC power e Battery disconnected or incorrectly connected e Battery low not charging depleted or bad e Blown battery fuse e Check battery connections See Replacing the Battery on page 61 e Recharge the battery See Recharging a Fully Discharged Battery on page 60 e Replace battery See Replacing the Battery on page 61 e Replace battery fuse See Replacing the Battery DC Fuse on page 63 Shuts down during printing Battery low or bad e Recharge the battery See Recharging a Fully Discharged Battery on page 60 e Replace battery See Replacing the Battery on page 61 Prints fewer than 10 reports on a full battery charge Degraded battery Replace battery See Replacing the Battery on page 61 Unresponsive for an extended time System frozen Press the reset button by inserting a small object such as a paper clip into the hole Reset button The screen is too dark or too light The contrast is to high or too low Press Ctrl R The contrast resets to its default value 70 Chapter7 Troubleshooting Table 4 System Messages alphabetical order Welch Allyn CP
58. p Settings The following screen appears Figure 23 Interpretation Settings Screen 9 17AM Oct 16 08 Interp Settings 1 Print Interpretation 2 Copies 3 Copies With Interp 4 Reason Statements 5 Unconfirmed Report 6 Abnormal ECG 0 Previous Menu Change any desired settings For a report example see Figure 21 on page 33 Setting Description Print Interpretation On or off Determines whether interpretation is printed and saved with reports Copies Number of copies to print automatically in addition to the original report 0 1 2 3 4 or 5 Copies With Interp On or off Determines whether interpretation is printed on the automatic copies Reason Statements On or off Determines whether reasons criteria are printed with the interpretation statements Unconfirmed Report On or off Determines whether the label Unconfirmed Report is printed on reports Abnormal ECG On or off Determines whether the label Abnormal ECG is printed on reports Available only for systems using automatic interpretation Directions for Use Chapter 4 Reviewing the ECG Settings 37 Reviewing the Patient Data Fields Available You can determine which fields appear during patient data entry To Choose the Fields 1 Press the Menu key 2 Choose ECG Settings gt Edit Auto Report gt Patient Data The following screen appears Figure 24 Patient Data Screen Patient Data lA 1 First Na
59. ply specifically to particular procedures such as connecting the patient cable or performing an ECG test appear in the corresponding sections of the manual Warning statements indicate conditions or practices that could lead to illness injury or death A Warnings Related to the Environment WARNING To ensure patient and device safety leave 5 feet 1 5 meters of open area around the patient WARNING To avoid a possible explosion do not use the electrocardiograph in the presence of flammable anesthetics mixtures containing air oxygen or nitrous oxide WARNING When transporting the electrocardiograph on a cart tuck the patient cable away from the wheels so that it does not present a hazard Warnings Related to Accessories and Other Equipment WARNING For operator and patient safety peripheral equipment and accessories that can come in direct patient contact must be in compliance with all appropriate safety EMC and regulatory requirements See EMC Guidance and Manufacturer s Declarations on page 75 WARNING All signal input and output I O connectors are intended for connection of only devices complying with IEC 60601 1 or other IEC standards for example IEC 60950 as appropriate to the device Connecting additional devices to the electrocardiograph might increase chassis or patient leakage currents To maintain operator and patient safety consider the requirements of IEC 60601 1 1 Measure the leakage currents to confirm
60. reducing AC interference Directions for Use Table 2 Lead Quality Problems Continued Chapter7 Troubleshooting 69 Condition Causes Actions AC interference even peaked regular voltage superimposed on the waveforms May resemble or coincide with muscle tremor interference e Electrodes that are dirty corroded loose or positioned on a bony area e Insufficient or dried electrode gel e Patient or technician touching an electrode during recording e Patient touching any metal parts of an exam table or bed e Broken lead wire patient cable or power cord Electrical devices in the immediate area lighting concealed wiring in walls or floors e Improperly grounded electrical outlet e Incorrect AC filter frequency setting or AC filter is turned off Check all electrode contacts and lead wires Verify that the patient is not touching any metal Verify that the AC power cable is not touching the patient lead cable e Verify that the proper AC filter is selected See Mains Filter on page 40 interference persists unplug the electrocardiograph from AC power and run it on the battery If this solves the problem you ll know that the noise was introduced through the power line e If interference still persists the noise may be caused by other equipment in the room or by poorly grounded power lines Try moving to another room e Table 3 System Failure Problems Conditi
61. rify that patient leads are fully inserted For details see Connecting the Patient Cable on page 20 Check for cracked or broken patient cable patient leads power cord communications cables display and enclosure Check for bent or missing pins on all cables Check all cable and cord connections reseat if any connectors are loose Cleaning the Equipment A WARNING To prevent the spread of infection the electrocardiograph and patient cable must be kept clean especially the components that come in contact with patients A Caution Do not let soap or water come into contact with the electrocardiograph s internal printer connectors or jacks Do not attempt to clean the electrocardiograph or the patient cable by submersing them in liquid autoclaving or steam cleaning Do not pour alcohol directly on the equipment or soak any components in alcohol If alcohol or liquids spill into the electrocardiograph while cleaning arrange to have it checked before using it again For Welch Allyn phone numbers see page ii Monthly or more often if needed follow these cleaning instructions 1 2 Disconnect the power plug from the AC outlet Wipe the exterior of the patient cable and electrocardiograph and with a damp cloth using mild detergent diluted in water Use 70 isopropyl alcohol to disinfect patient cable lead wires and equipment Dry all components with a clean soft cloth or paper towel Wait at least 10 minutes t
62. s 58 clinical conditions See history list Com ports locations 8 configuration transferring 30 configuration See ECG settings system settings confirming See interpretation of ECGs automatic confirming contact information entering your 27 contact information for Welch Allyn ii contrast adjusting 69 Control key Ctrl 9 69 copies number to print 36 Customer Service ii D database See CardioPerfect workstation data See patient data date and time 27 33 34 defibrillation precautions 16 17 20 demographics See patient data device configuration settings 27 device ID 27 33 34 Device Info screen 29 digital sampling rate 73 dust cover ordering 6 E ECG acquisition screen 50 ECG post print screen 51 ECGs performing tests 43 55 settings 10 31 41 See also Auto ECGs Rhythm ECGs 82 Index editing Auto Report ECG settings 39 miscellaneous ECG settings 40 report formats 33 38 electrodes labeling schemes See AHA IEC ordering 6 placement locations 4 45 46 specifications 74 troubleshooting 68 electromagnetic emissions See EMC guidance and declarations electronic medical records EMR 2 EMC guidance and declarations 75 78 Enter New Patient screen 49 equipotential stud 7 17 exporting tests to memory card 51 extended measurements 35 F features 3 filters types of 74 See also specific filter names flow task diagrams Auto ECG testing normal and stat
63. s for Use Chapter 5 Performing ECG Tests 45 Figure 27 Electrode Placement Locations Adult and Standard Pediatric G H Electrodes AHA IEC Locations A V1 C1 Fourth intercostal space at right sternal border red red B V2 C2 Fourth intercostal space at left sternal border yellow yellow C V3 C3 Midway between V2 and V4 green green D V4 C4 Fifth intercostal space at left of midclavicular line blue brown E V5 C5 Anterior axillary line at same horizontal level as V4 orange black F V6 C6 Mid axillary line on same horizontal level as V4 and V5 purple purple G LA L Just above left wrist on inside of arm black yellow H LL F Just above left ankle red green l RL N Just above right ankle green black J RA R Just above right wrist on inside of arm white red 46 Chapter5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Figure 28 Electrode Placement Locations Augmented Pediatric To use the augmented pediatric lead set you must enable it in the settings See Turning the Augmented Pediatric Lead Set On and Off on page 41 F G Electrodes AHA IEC Locations A V1 C1 Fourth intercostal space at right sternal border red red B V2 C2 Fourth intercostal space at left sternal border yellow yellow C V4 C4 Fifth intercostal space at left of midclavicular line blue brown D V7 C7 Posterior axillary line at the same horizontal level as V4 orange black E V6 C6 Mid axillary
64. sale of the software or any copy of the software all right title and ownership of the software remains with Welch Allyn or its vendors For information about any Welch Allyn product please call Welch Allyn Technical Support USA 1 800 535 6663 Australia 61 29 638 3000 1315 685 4560 Canada 1 800 561 8797 China 86 216 327 9631 European Call Center 353 46 906 7790 France 4 331 6009 3366 Germany 49 747 792 7186 Japan 81 33 219 0071 Latin America 1 305 669 9003 Netherlands 31 15 750 5000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Reorder Number multi language CD 401150 Mat Number manual only 708794 Ver F Welch Allyn Welch Allyn LTD Ec Rep 4341 State Street Road PO Box 220 Navan Business Park Skaneateles Falls NY 13153 0220 Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67755 www welchallyn com Printed in USA C 0297 WelchAllyn Contents Te dnitrOG UG HOT os eere hols Ag Rl dentes ande EBA KANAN 1 About his Manual ca oes ee ee RO IPAE E 2 Product OVer vie wai tor A RD ISTIS MeL IC Seb idees 2 Intended USED 2a Na nat eter eee riot Behar NA ere Qus Cel dod 2 Indications forse 0 cerea Rex mx Peed dae RR ARR a ase 3 Standard Features amp Benefits iunc be pen o dd es eee eed 3 OPTIONS ds Rott nt ae aret ad x disce lA aces a mI A AAN tr LEN E 5 ACGCeSSOTIGS ut oru e d d mta t be
65. sary Welch Allyn CP 100 Electrocardiograph Rhythm ECG A continuous real time printout of ECG data See also Auto ECG workstation See CardioPerfect workstation Index 81 3x4 6x2 12x1 etc See leads arrangements formats in Auto Reports 3x4 50 mm s 3R 6x2 50 mm s 6R See average cycles 5 mm mV 10 mm mV etc See gain settings 50 or 60 Hz filter See AC filter A Abnormal ECG label 36 About screen device information 29 accessories 6 17 71 AC filter 33 34 40 69 AC fuses replacing 64 AC interference 68 69 AC power See powering the electrocardiograph acquisition screen 50 AHA electrode labels V1 V2 V3 etc 40 45 46 arrow keys using 11 artifact report 39 audio beeper 27 augmented lead set 4 41 46 47 Auto ECG Acquisition screen 50 Auto ECG Post Print screen 51 Auto ECGs recording 48 53 report settings 33 38 automatic interpretation See interpretation of ECGs automatic shutdown See Power Save average cycles 35 73 B baseline centering 39 baseline filter default choosing on or off 40 enabling and disabling 55 battery maintenance 22 60 63 ordering 6 specifications 73 Bazett QTc method 39 beeper 27 C C1 C2 C3 etc See IEC electrode labels Cabrera lead grouping scheme 40 73 CAPS Lock 28 CardioPerfect workstation about 2 3 carts 5 6 15 caution symbol defined 13 CD product information ordering replacement 6 cleaning procedure
66. scard the fuse See Figure 43 You may need to pull hard Use pliers gently if necessary Connect a new fuse It goes in either way Go to Step 8 on page 62 Figure 43 Battery Fuse Removed SI AM a 64 Chapter 6 Maintaining the Electrocardiograph Welch Allyn CP 100 Electrocardiograph Replacing the AC Fuses If the green LED on the keyboard does not light up when the electrocardiograph is connected to AC power you may need to replace one or both of the AC fuses as follows For the fuse value see Fuses on page 73 1 Unplug the electrocardiograph from AC power if connected A WARNING Failure to unplug could result in electrocution Use needle nosed pliers to remove the fuse case See Figure 44 Inspect the fuses If either fuse is dark or has a broken wire replace the fuse See Figure 45 Insert the fuse case Line it up with the opening it goes in only one way Figure 44 Removing AC Fuse Case Figure 45 AC Fuses Removed Directions for Use Chapter 6 Maintaining the Electrocardiograph 65 Storing the Equipment When storing the electrocardiograph cords and accessories observe the environmental storage conditions See Specifications on page 73 Discarding the Equipment Discard the old battery appropriately e n the USA call 1 800 SAV LEAD for instructions on recycling it a e International users contact your local authorities concerning recycling Discard the electrocardiograph cords and
67. that no electric shock hazard exists In the case of a USB printer the printer non medical electrical equipment shall be situated outside the patient environment reference IEC 60601 1 1 The printer used should be approved to the appropriate safety standard for non medical electrical equipment IEC 60950 or its national variants and use of an isolation transformer is recommended If there is a requirement for the printer to be situated within the patient environment it is the responsibility of the user to ensure that the system provides a level of safety in compliance with IEC 60601 1 and 60601 1 1 WARNING The electrocardiograph has not been designed for use with high frequency HF surgical equipment and does not protect against hazards to the patient 16 Chapter 1 Introduction A Welch Allyn CP 100 Electrocardiograph Warnings Related to Using the Electrocardiograph WARNING This device captures and presents data reflecting a patient s physiological condition When reviewed by a trained physician or clinician this data can be useful in determining a diagnosis However the data should not be used as a sole means for determining a patient s diagnosis WARNING To avoid serious injury or death take these precautions during patient defibrillation e Avoid contact with the electrocardiograph patient cable and patient e Verify that the patient leads are properly connected See Connecting the Patient Cable on page 20 e
68. tion device info user setup and page 25 so on Directions for Use Chapter 1 Introduction 11 Moving Through the Menus Figure 9 Standard Menu Figure 10 Parent Menu With Submenu Edit Auto Report Format 1 Lead Arrangement 2 Rhythm Lead 1 3x4 3R 3 Rhythm Lead 2 6x2 4 Rhythm Lead 3 12x1 2 Interp Settings 3 Patient Data 0 Previous Menu 5 Extended Measurements 6x2 50 mm s 6 Average Cycles 6x2 10 Ext 0 Previous Menu 2x6 1R Desired Actions Keys to Press To move up or down a list Ary To open a standard menu Figure 9 LI or p or item s number or letter To move from parent menu to submenu on same screen Figure 10 To perform an action JJ To accept data iti To check or uncheck a checkbox To select the highlighted submenu To return to parent menu from submenu on same im E item screen Figure 10 or To make no change To move back through the menus d4 or zero key To move through data entry fields or To return to the Ready screen from a standard menu KR Figure 9 X 12 Chapter 1 Introduction Welch Allyn CP 100 Electrocardiograph About the Patient Cable and Leads The patient cable processes the patient s ECG data and transmits it to the electrocardiograph To make handling convenient the ten leads are arranged to point toward the appropriate parts of the body The cable rake which slides easily prevents the chest leads from tangling Figure 11 Patient Cab
69. up 26 miscellaneous ECG settings 40 41 muscle filter 40 55 muscle tremor interference 68 69 33333 3 N navigating through the menus 11 Directions for Use O on off manual and automatic 23 options 5 ordering information 6 P pacemakers use with 4 17 73 paper See thermal chart paper parts and accessories 6 17 71 patient cable connecting 20 44 47 description amp illustration 12 ordering 6 precautions 17 See also electrodes leads patient data enabling and disabling fields 37 entering 49 as printed on reports 33 34 phone numbers ii poster ordering replacement 6 post print screen 51 powering the electrocardiograph 22 23 73 Power Save 23 27 practice ID 27 33 printer external 3 24 73 printer external USB 24 28 73 printer internal thermal 59 73 Print Settings printing your settings 29 print settings report settings See Auto ECGs report settings Rhythm ECGs report settings Q QTc method 32 39 R Ready screen 47 reason statements 36 recycling instructions 65 repairs 72 replacement parts and accessories 6 71 reports See Auto ECGs Rhythm ECGs reset button 8 69 Rhythm ECGs recording 54 55 Index 83 S safety 15 17 sampling rate digital 73 SD memory card See memory card sending tests to memory card 51 sequential lead timing 39 serial number displaying 29 service policy 72 set up See hardware set up
70. uration Electrode Labels Default Gain Setting Default Baseline Filter Default Muscle Filter Mains Filter Standard 11 Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 or Cabrera aVL aVR II aVF Ill V1 V2 V3 V4 V5 V6 AHA or IEC 5 mm mV 10 mm mV 20 mm mV or Auto AUTO is available for Auto ECGs only not rhythm ECGs AUTO is usually the best setting but some waveforms may be easier to read on other settings For details see Adjust Gain on page 55 On or off For details see Adjust Baseline Filter on page 55 On or off For details see Adjust Muscle Filter on page 55 Off 50 Hz 60 Hz Use of this filter is recommended For suggestions on eliminating AC interference see page 69 Directions for Use Chapter 4 Reviewing the ECG Settings 41 Turning the Augmented Pediatric Lead Set On and Off For a description of the augmented pediatric lead set see page 4 1 Press the Menu key 2 Choose ECG Settings gt Augmented Lead Set gt On or Off When this option is turned on the system will prompt you to select the lead set standard or augmented each time you perform a test on a new patient 42 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 100 Electrocardiograph 4 Performing ECG Tests Connecting the Leads to the Patient 0c eee eee eee 44 Recording an Auto ECG iii ci Se ee Ran ee ern n ia ac 48 Recording a Rhythm ECG uisa A AG tirien RR did 54 Adjusting the ECG
71. vides automatic analysis of ECG tests For more information see the MEANS Physicians Manual or the PEDMEANS Physicians Manual on the CD that came with your electrocardiograph The MEANS algorithm is used for adult patients 18 years and older The PEDMEANS algorithm is used for pediatric patients from 1 day through 17 years old Carts Two specially designed carts are available for convenient transport and use of the electrocardiograph as shown here with the optional cable arm and shelf Figure 1 Office Cart Figure 2 Hospital Cart Cable arm and shelf optional Cable arm and shelf optional Durable high quality rubber wheels with locks Free motion plastic wheels 5 6 Chapter 1 Introduction Accessories To order accessories call Welch Allyn For phone numbers see page ii Welch Allyn CP 100 Electrocardiograph Item Customer Order Number Quantity Resting tab electrodes 45008 0000 1000 Resting tab electrode adaptors 58581 0000 10 Thermal chart paper 1 case 5 pads 200 sheets each 94018 0000 1 case Welch cup RE ELEC CUP 1 Limb lead clamps IEC RE ELEC CLP 4 Limb lead clamps AHA 401432 4 Patient cable Figure 11 on page 12 e AHA 400293 1 e IEC 400294 1 e EC vacuum adapter 100920 1 e Vacuum system VAC DT100 CP Lead wires 10 wires per set e AHA banana 401129 1 set e EC banana 401122 1 set e AHA pinch 401123 1 set e IEC pinch 401124 1 set Battery Figure 3
72. waveforms It is preferable if possible to eliminate or reduce muscle tremor by addressing the causes as explained on page 68 To learn how to change the filter s default setting see Reviewing the Miscellaneous ECG Settings on page 40 Caution You cannot perform ST segment analysis on waveforms that were recorded with the muscle filter turned on For details see the caution on page 52 Ple bulis Muscle tremor interference Adjust Speed available for Rhythm ECG only Cycles through the paper speed settings in mm sec 10 25 50 LIE 10 mm sec Lot JJ 25 mm sec IA 50 mm sec 56 Chapter5 Performing ECG Tests Welch Allyn CP 100 Electrocardiograph Maintaining the Electrocardiograph Inspecting the Equipment soleo Rm oh Rost Re a oe 58 Cleaning the Equipment 0 000 een 58 Testing the Equipment s isome camedd Sie lee wae Roum DRA SU cA i 59 Recharging a Fully Discharged Battery 00 eee eee 60 Replacing the Battery osorno de KAKA deuri ean eee ade I ES E EXE 61 Replacing the Battery DC Fuse 0 0 ccc ccs 63 Replacing the AC FUSES oi scada ee eden eRe ee a 64 Storing the Equipment siecle KG p eta eee eee ee md 65 Discarding the Equipment cssc e ra RR eR 65 57 58 Chapter 6 Maintaining the Electrocardiograph Welch Allyn CP 100 Electrocardiograph Inspecting the Equipment WARNING To ensure patient safety and proper operation perform the following inspections daily Ve
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