CP 50 User Manual
Contents
1. liliis ess 32 Replacing the battery liliis 33 Replacing the AC fUSes sse ra eraot Le ond ned xw endo we PR Nae de d 34 Sanang the SQUIPMENt ex sort ea RR S Ede ode Se t e QC P e pt 34 Discarding the equipment 0000 eee 34 6 Troubleshooting anaana ce eee eee eens 35 Limited warrantys lt 24 242 2864 BRUM Ud eie d tite i i 39 SOenvICeDolloy Coe E Oa ted AM NRI Gino dance A 40 iv Contents Welch Allyn CP 50 resting electrocardiograph A pechicatiotiSu Lu yd A ee eh ERU nud A 41 B EMC guidance and manufacturer s declarations 43 Introduction About this document This document is written for clinical professionals with a working knowledge of medical procedures and terminology required for monitoring cardiac patients Before using the electrocardiograph for clinical applications or before setting up configuring troubleshooting or servicing the electrocardiograph you must read and understand this document and all other information that accompanies the electrocardiograph and related options or accessories Intended use The Welch Allyn electrocardiography products subject devices are intended for use by trained operators in health facilities The subject devices provide the following diagnostic functions e Acquiring viewing storing and printing ECG waveforms using ECG front end modules patient cables and associated accessories that provide signal acquisition f2. Z fold thermal paper should stop with perforations near the tear bar indicating proper cue sensor operation 3 If you see any indications of improper operation call Welch Allyn Technical Support 18 Setup Welch Allyn CP 50 resting electrocardiograph Connecting to an external USB printer optional CP 50 Plus only You can connect a CP 50 Plus electrocardiograph to an external printer The printer must be a USB inkjet or laser printer that supports PCL printer control language No special software is required The external printer prints auto ECG reports always in black and white Rhythm ECGs always print to the internal printer Cables longer than three meters have not been verified for use with the electrocardiograph Do not use cables longer than three meters To connect to an external USB printer 1 Connect one end of a USB cable to the printer s USB connector and connect the other end to the electrocardiograph s USB connector 2 Enable the external printer a Touch the menu button b Touch Settings gt ECG gt Auto report 1 or Auto report 2 c Under Printer select External Directions for use Setup 19 Connecting to a CardioPerfect workstation optional CP 50 Plus only You can connect a CP 50 Plus electrocardiograph to a Welch Allyn CardioPerfect workstation via USB cable or via Ethernet cable After you connect you can do the following from the electrocardiograph e
3. orange black F V6 C6 Mid axillary line at the same horizontal level as V4 and purple purple V5 G LA L Just above the left wrist on the inside of the arm black yellow H LL F Just above the left ankle red green RL N Just above the right ankle green black J RA R Just above the right wrist on the inside of the arm white red 24 ECG testing Welch Allyn CP 50 resting electrocardiograph Performing an ECG test 1 Attach the leads to the patient Any flashing dots on the lead status screen indicate unattached or poorly attached leads 2 aio Lj m O When all leads have been attached for several seconds the ECG preview screen appears DD MM YYYY 00 00 AM LIES C iil all cd oooe N Mim Gain button Filters button size Leads button Speed button If an Artifact message appears minimize the artifact as described under Troubleshooting You might need to ensure that the patient is comfortably warm reprepare the patient s skin use fresh electrodes or minimize patient motion Optional Adjust the waveforms using the buttons to cycle through the options leads displayed gain size speed filters Perform the desired type of test stat ECG auto ECG or rhythm ECG Stat ECG Auto ECG Rhythm ECG 2 Optional 2 Enter patient data 3 Touch n Change settings 3 To stop press i Directions for use ECG testing 25 For auto ECGs y
4. Whenever the electrocardiograph is serviced or whenever problems are suspected verify continued electrical safety of the device using IEC 60601 1 or ANSI AAMI ES1 methods and limits WARNING Only qualified service personnel should perform leakage current tests Test for the following Patient leakage current Chassis leakage current Earth leakage current Dielectric strength AC and patient circuits Directions for use Maintenance 33 Replacing the battery Replace the battery under these circumstances e lt loses its charge quickly e You have charged it and the electrocardiograph still does not turn on when unplugged The first time that you press the power button after installing a new battery the electrocardiograph goes through some diagnostic tests that cause it to take longer than usual to power up Discard the old battery appropriately Contact your local authorities concerning recycling To replace the battery 34 Maintenance Welch Allyn CP 50 resting electrocardiograph Replacing the AC fuses You might need to replace one or both of the AC fuses if the AC power indicator does not light up when the electrocardiograph is connected to AC power A WARNING Failure to unplug could result in electrocution To replace the AC fuses 1 If either fuse is dark or has a broken wire replace the fuse Line up the fuse case with S th
5. Y Li ion Battery is absent or faulty Battery is charged to the indicated level Battery is charging Battery door Rechargeable battery Nonionizing electromagnetic radiation Lithium ion 6 Introduction Connectivity symbols Welch Allyn CP 50 resting electrocardiograph A USB Li Ethernet RJ45 Shipping storing and environment symbols This end up U Fragile 50 C Temperature limits 20 C X A Separate the battery from other disposables for recycling Separate the device from other disposables for recycling See www welchallyn com weee D P p 95 RA 700 1060 hPa Oo amp Keep dry Relative humidity limit Atmospheric air pressure limits Recycle China RoHS restriction of hazardous substances symbols for control of pollution caused by electronic information products 5 year environment friendly use period EFUP for batteries 10 year EFUP for the device For details see the accompanying documentation Miscellaneous symbols Heartbeats per minute b4 min il iv C Meets essential requirements of European 0297 Medical Device Directive 93 42 FEC Manufacturer Defibrillation proof Type CF applied parts Reorder number Do not reuse EE em 4l B LOT EC REP 1 Hot surface Do not touch Date of manufacture Defibrillation proof Type BF applied parts Serial
6. 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 all components that come in contact with patients 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 To ensure safe use of the device follow the documented maintenance procedures WARNING Only qualified service personnel should attempt to repair the electrocardiograph In case of a malfunction call Technical Support WARNING Do not perform ST segment analysis on the ECG screen display since these ECG representations are scaled Make manual measurements of ECG intervals and magnitudes on printed ECG reports only WARNING To avoid injury do not touch the print head immediately after printing It might be hot Directions for use Introduction General cautions Cautions indicate conditions or practices that could damage the equipment or other property gt gt bbb PP DP gt gt Caution When removing the electrocardiograph from storage allow it to thermally s
7. number Batch code European community representative Software activation code Directions for use Introduction 7 General warnings Warnings indicate conditions or practices that could lead to illness injury or death Warnings related to the environment A WARNING To avoid a possible explosion do not use the electrocardiograph in the presence of flammable anesthetics mixtures containing air oxygen or nitrous oxide A 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 A 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 A 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 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
8. the audit trail on or off CP 50 Plus only An audit trail a collection of information about user activity may be helpful or even required for record keeping It records the user identity code and time associated with each use of the electrocardiograph including these types of activity accessing the test directory searching the worklist editing patient data accessing administrative functions When the audit trail is turned on the electrocardiograph collects this type of information in a file in its memory To turn the audit trail on or off 1 Touch the menu button 2 Touch Settings gt Security 3 Turn the audit trail on or off Directions for use Administrative tasks 29 Managing the worklist CP 50 Plus only The worklist is a group of patients whose demographic data has been entered into the electrocardiograph memory to be recalled for a test later that day The worklist holds up to 50 patients When you perform an auto ECG you can fill in the patient s data from the worklist automatically by touching the Worklist button You can add or delete patients any time If the electrocardiograph is connected to an EMR you can also download a worklist To manage the worklist 1 Touch the menu button 2 Touch Worklist 3 Add patients delete patients or download a worklist Managing the test directory The test directory is a group of ECG tests that have been saved in the electrocardiograph memory The test dire
9. which the CP 50 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 P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 46 EMC guidance and manufacturer s declarations Welch Allyn CP 50 resting electrocardiograph Recommended separation distances between portable and mobile RF communications equipment and the CP 50 electrocardiograph The CP 50 electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the CP 50 electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CP 50 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 transmitter W d 1 17 P d 1 17 P d 2 33 P 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 70 737 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed
10. 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 A WARNING The electrocardiograph has not been designed for use with high frequency HF surgical equipment and does not protect against hazards to the patient 8 Introduction Welch Allyn CP 50 resting electrocardiograph Warnings related to using the electrocardiograph A A 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 or prescribing treatment 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 e 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
11. CP 50 and CP 50 Plus 12 lead resting electrocardiograph Directions for use WelchAllyn Advancing Frontline Care ii Welch Allyn CP 50 resting electrocardiograph 2009 Welch Allyn Inc All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Caution Federal US law restricts sale of the device identified in this manual to or on the order of a licensed physician 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 CP 50 CP 50 Plus and CardioPerfect are trademarks of Welch Allyn Inc PDI and Sani Cloth are registered trademarks of PDI Inc CaviWipes is a trademark of Metrex Research Corporation 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 ot
12. EMC and regulatory compliance Standard connectivity Connectivity with electronic medical records CP 50 Plus only Electrodes Power cable Patient cable and leads Environmental operating conditions Temperature Relative humidity Atmospheric air pressure limits Environmental storage conditions Temperature Relative humidity Atmospheric air pressure limits Protection against electric shock Mode of operation 0 5 Hz 35 Hz 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 1 6 IEC EN 60601 2 25 IEC EN 60601 2 51 2x6 lead arrangement Mini USB client and USB host Ethernet CP 50 Plus only Through the Welch Allyn CardioPerfect workstation software Rigorously tested for conductivity adhesion and hypoallergenic qualities and exceed all AAMI standards Meets or exceeds Type SJT Meets or exceeds ANSI AAMI EC53 EN IEC 60601 2 25 and EN IEC 60601 2 51 4109 C to 440 C 450 F to 104 F 15 9596 noncondensing 30 7096 for printing 700 1060 hPa 20 C to 50 C 4 F to 4122 F 15 9595 noncondensing 700 1060 hPa Class I internally powered Type BF Continuous If you print at a high gain setting the waveform or calibration marks might be clipped This clipping does not comply with
13. RTICULAR 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 CONSEOUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY 40 Troubleshooting Welch Allyn CP 50 resting electrocardiograph Service policy All repairs on products under warranty must be performed by Welch Allyn or by a service provider authorized by Welch Allyn Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair should be performed exclusively by Welch Allyn or by a service provider that has been authorized by Welch Allyn If the product fails to function properly or if you need assistance service or spare parts contact the nearest Welch Allyn Technical Support Center 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 model number and serial number of your product e Complete description of the problem 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 reguires warranty extended warranty or non warranty repair service please call fir
14. Send ECG tests to the workstation e Search for patient data in the workstation database Cables longer than three meters have not been verified for use with the electrocardiograph Do not use cables longer than three meters To connect to a workstation via USB cable Connect the electrocardiograph to any of the workstation s USB ports No software configuration is required The electrocardiograph is ready to communicate To connect to a network connected workstation via Ethernet cable 1 Connect the electrocardiograph to the same network as the workstation If you need help consult with your network administrator A WARNING To reduce the risk of fire and shock hazards connect Ethernet cables within the boundaries of a single building Ethernet cables that span multiple buildings can introduce fire or shock hazards unless fiber optic cables or lightning arrestors are properly installed or other appropriate safety measures are taken 2 Goto the CP 50 connectivity screen a Touch the menu button b Touch Settings gt System gt Network 3 Fill in the screen e f DHCP is enabled for the network select the DHCP checkbox e f DHCP is not enabled fill in the fields static IP address subnet mask and default gateway 20 Setup Welch Allyn CP 50 resting electrocardiograph Touch Test Connect to the network a Inthe Hos
15. above the recommended separation distance d in 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
16. ata confidential When the security option is off user login is never required When the security option is on user login is required for the following tasks searching for patient data managing the test directory managing the worklist managing the user list managing the audit trail A user s level of access is either user or administrator as determined in the user list To turn the security option on or off 1 Touch the menu button 2 Touch Settings gt Security 3 Turn the security option on or off 28 Administrative tasks Welch Allyn CP 50 resting electrocardiograph Managing the user list CP 50 Plus only The user list which is enabled when the security option is on identifies all individuals who are authorized to access patient data The user list can hold up to 25 users After the list reaches 25 users you can add users only if some users are set to inactive status New users replace inactive users If all 25 users are active you receive a message that the user list is full Two levels of access can be assigned e User level Userlevel users have access to the test directory and the worklist including searching and editing privileges e Administrator level Administrator level users have userlevel access and can also create and administer users To manage the user list 1 Touch the menu button 2 Touch Settings gt System gt Users 3 Add edit delete activate or deactivate users Turning
17. atients and damage to the device A WARNING To avoid injury to the patient or damage to the device never plug patient leads into any other device or wall outlet Caution Always connect the patient cable and the leads properly during defibrillation Otherwise the connected leads could be damaged 12 Setup Welch Allyn CP 50 resting electrocardiograph Loading the thermal paper The electrocardiograph prints on z fold thermal paper or roll thermal paper e Store the paper in a cool dry dark place e Do not expose it to bright light or UV sources e Do not expose it to solvents adhesives or cleaning fluids e Do not store it with vinyls plastics or shrink wraps To load z fold thermal paper 1 O OO i 2 E NY amyl Directions for use Setup 13 S To load a roll of thermal paper WelchAltyn WelelyAllyn 14 Setup Welch Allyn CP 50 resting electrocardiograph Powering the electrocardiograph The electrocardiograph runs on AC or battery power Plug the electrocardiog
18. cardiograph 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 JP 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 a Note 1 At 80 MHz and 800 MHz 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 a 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 broadcast 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
19. clause 51 103 1 of the IEC EN 60601 2 51 standard Use a lower gain setting to observe the full waveform 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 50 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 43 EMC guidance and manufacturer s declarations Electromagnetic emissions The CP 50 electrocardiograph is intended for use in the electromagnetic environment specified below The customer or user of the CP 50 electrocardiograph should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The CP 50 electrocardiograph uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to CISPR 11 cause any
20. commercial or hospital IEC 61000 4 5 2 kV common mode 2 kV common mode environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 gt 95 dip in 0 5 cycle 6096 dip in 5 cycles 3096 dip for 25 cycles gt 95 dip in 5 seconds 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 If the user of the CP 50 electrocardiograph requires continued operation during power mains interruptions it is recommended that the CP 50 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 EMC guidance and manufacturer s declarations 45 Electromagnetic immunity The CP 50 electrocardiograph is intended for use in the electromagnetic environment specified below The customer or user of the CP 50 electrocardiograph should assure that it is used in such an 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 50 electro
21. ctory holds at least 25 ECG tests When you perform an auto ECG you can fill in the patient s data from the test directory automatically by touching the search button With all electrocardiograph models you can delete or print saved tests With CP 50 Plus models you can also do the following e Edit the patient data in saved tests e Send saved tests to a USB mass storage device or to a Welch Allyn CardioPerfect workstation Any tests that you send to a USB mass storage device can be retrieved only from a CardioPerfect workstation To manage the test directory 1 Touch the menu button 2 Touch Tests 3 Delete edit print or send saved tests Options vary per model 30 Administrative tasks Welch Allyn CP 50 resting electrocardiograph 31 Maintenance Cleaning the equipment A WARNING Keep the electrocardiograph and the patient cable clean Patient contact with contaminated equipment can spread infection Caution Never let soap or water come into contact with the electrocardiograph s internal printer connectors or jacks A Caution Never immerse the electrocardiograph or the patient cable in liquid Never autoclave or steam clean the electrocardiograph or the patient cable Never pour alcohol directly on the electrocardiograph or the patient cable and never soak any components in alcohol If any liquid enters the electrocardiograph remove the electrocardiograph from service and have it inspected by a qualifi
22. e The System settings which control the overall device e The Security settings which control user login and the audit trail To view or change the settings 1 Touch the menu button 2 Touch Settings gt ECG or System or Security 3 Make changes as needed Viewing the device information You can view device information in two places e The About screen which lists the model number serial number software versions RAM usage available NAND e The Upgrade screen which lists the installed options To view the device information 1 Touch the menu button 2 Touch Settings gt System gt About or Upgrade Directions for use Setup 17 Verifying proper operation To ensure the accuracy of test data you should verify proper operation of the electrocardiograph before it is used for the first time with patients You should reverify proper operation once a year To verify proper operation 1 Use an ECG simulator to acquire and print a standard 12 lead ECG of known amplitude and rate 2 Look for the following indications of proper operation Printing should be dark and even across the page There should be no evidence of print head dot failure no printing breaks forming horizontal streaks Thermal paper should move smoothly and consistently during printing The waveforms should have no distortion or excessive noise The amplitude and rate of the waveforms should match the input value from the ECG simulator
23. e opening it goes in only one way storing the equipment When storing the electrocardiograph cords and accessories observe the environmental storage conditions that are identified in the product specifications Discarding the equipment Discard the electrocardiograph cords and accessories according to local laws Do not dispose of this product as unsorted municipal waste Prepare this K 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 35 Troubleshooting Lead quality problems Artifact message on the screen Artifact is signal distortion that makes it difficult to accurately discern the waveform morphology Causes e The patient was moving e The patient was shivering e There is electrical interference Actions See actions for wandering baseline muscle tremor and AC interference Wandering baseline Muscle tremor Wandering baseline is an upward and downward fluctuation of the waveforms oho Causes Electrodes are dirty corroded loose or positioned on bony areas The electrode gel is insufficient or dried The patient has oily skin or used body lotions Ris
24. ed service person before using it again Acceptable cleaning solutions Mild detergent and water 12 tsp detergent per cup of water Bleach and water 1 part bleach 6 00 sodium hypochlorite with 9 parts water Isopropyl alcohol and water 70 by volume PDI Sani Cloth Plus wipes 14 85 isopropanol CaviWipes 17 2 isopropanol To clean the equipment monthly or more often if needed 1 Q Disconnect the power plug from the AC outlet 2 Turn off the electrocardiograph Press and hold the power button for at least six seconds until the screen goes blank Dampen a cloth with any of the acceptable cleaning solutions and 3 wipe the exterior of the patient cable and electrocardiograph Dry all components with a clean soft cloth or paper towel 4 Before you turn on the electrocardiograph again wait at least 10 minutes for all traces of liquid to evaporate 32 Maintenance Welch Allyn CP 50 resting electrocardiograph Inspecting the equipment Perform the following inspections daily e Check for cracked or broken patient cable patient electrodes power cord communications cables display and enclosure e Check for bent or missing pins on all cables e Check all cable and cord connections reseat if any connectors are loose Testing the electrocardiograph Welch Allyn recommends verifying proper operation of the electrocardiograph once a year to ensure reliability See Verifying proper operation on page 17
25. es Report formats external printer Auto ECGs Average cycles ECG storage in test directory Patient storage in worklist CP 50 Plus only Freguency range Digital sampling rate Pacemaker detection Power reguirement AC fuses Rechargeable battery 32 5 x 8 x 18 8 cm 12 8 x 3 1 x 7 4 in 2 0 kg 4 4 Ib Polyester overlay TFT 11 cm 4 3 in color touch screen WOVGA 480 x 272 11 4 cm 4 5 in x 250 sheets 11 4cm 4 5in x20 m Computer controlled dot array 8 dots mm 10 25 50 mm s 2 5 5 10 20 mm mV AUTO 2 5 5 10 20 mm mV Standard Cabrera 3x4 3x44 1R 2x6 3 leads 3x4 3R 25 mm s 3x4 3R 50 mm s 2x6 1R 25 mm s 2x6 1R 50 mm s 3x4 3x4 1R 3x4 3R 6x2 12x1 3x4 3R 25 mm s 3x4 3R 50 mm s 2x6 1R 25 mm s 2x6 1R 50 mm s 3x4 2R 25 mm s 3x4 2R 50 mm s 6x2 2R 50 mm s At least 25 ECG tests Up to 50 patients 0 3 to 150 Hz gt 1 000 samples second channel ANSI AAMI EC11 Universal AC power supply 110 240 V 50 60 Hz 1 5 A maximum Time lag type 2 0 amp 250 V rating Littlefuse 0218002P or equivalent 10 8V 1 9Ah minimum 3 cells Li ion smart battery A fully charged battery prints up to 25 ECGs with one extra copy per test 42 Specifications Welch Allyn CP 50 resting electrocardiograph Item Continued Specification Continued Filters High performance baseline Muscle tremor AC interference Safety
26. herwise reduced to human perceivable form This is not a 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 Welch Allyn Technical Support European Customer Care 35 3 46 906 7790 France 33 155 69 58 49 Germany 49 6950 985 132 China 86 21 6327 9631 Latin America Miami office 1 305 669 9003 Netherlands 31 202 061 360 Malaysia 60 3 7875 3341 Sweden 46 858 536 551 United Kingdom 44 20 7365 6780 Australia 61 2 9638 3000 Multilanguage CD 102731 This manual DIR 80015344 Ver B geal EC REP Welch Allyn Ltd Navan Business Park Dublin Road Navan County Meath Republic of Ireland www welchallyn com CE a WelchAllyn Contents 1 ntrodiictionn so Ce Dec Da Rb Rae re a he nds we ts 1 About this d6cunnent a beu ae gwl teet s ten Tot dg doen ql e Y EY Tn den dd Wei Aad 1 Intendedusekae ue bou oY A pb wee tate WNA Ad ynyd 1 ImdicationssTOnnUS amp cioe etd n ENS DEED Re YN 1 Aboutthe test typis c ik ge Edn tee Se ceeded eee UD 2 Feat ceu MERE cM RR SEM ROMA Cd 3 Controls indicators and connectors 0 ees 4 SVITIDOIS usd Aa y act Ratte t idk rete sath oak d La Bho oe AM Ag J AUK a tts d D es t P CASE 5 General Warhings s ede pes er Dr orem a edet dh edi e ap ed red dco 7 General CaltioriSe zx acte ved seta sce E NR Sack DURER RS RR VARRO o dea NOS 9 2 SB Ls HR HEN Wwe ee era a Er a ET HONN 11 Gonnecting ther
27. ing and falling of chest during rapid or apprehensive breathing Actions Clean the patient s skin with alcohol or acetone Reposition or replace the electrodes Verify that the patient is comfortable warm and relaxed If wandering baseline persists turn the baseline filter on Muscle tremor interference superimposes random irregular spikes on the waveforms 36 Troubleshooting Welch Allyn CP 50 resting electrocardiograph Causes e The patient is uncomfortable tense nervous e The patient is cold and shivering e The exam bed is too narrow or short to comfortably support arms and legs e The arm or leg electrode straps are too tight Actions AC interference Verify that the patient is comfortable warm and relaxed Check all electrode contacts If interference persists turn the muscle tremor filter on If interference still persists the problem is probably electrical in nature See the suggestions for reducing AC interference in a related troubleshooting tip AC interference superimposes even peaked regular voltage on the waveforms Causes e The patient or technician was touching an electrode during recording e The patient was touching a metal part of an exam table or bed e A lead wire patient cable or power cord are broken e Electrical devices in the immediate area or lighting or wiring concealed in walls or floors are interfering An electrical outlet is improperly grounded The AC filter is tu
28. interference in nearby electronic equipment RF emissions Class A The CP 50 electrocardiograph is suitable for use in all establishments other than domestic and those directly connected to the public low CISPR 11 voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 44 EMC guidance and manufacturer s declarations Welch Allyn CP 50 resting electrocardiograph Electromagnetic immunity The CP 50 electrocardiograph is intended for use in the electromagnetic environment specified below The customer or user of the CP 50 electrocardiograph should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ESD ceramic tile If floors are covered with 8 kV air 8kV air synthetic material the relative humidity IEC 61000 4 2 should be at least 3096 Electrical fast transient 2 kV for power supply 2 kV for power supply Mains power quality should be that of a burst lines lines typical commercial or hospital environment IEC 61000 4 4 1 kV for input output Not applicable lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical
29. or 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 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 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 2 Introduction Welch Allyn CP 50 resting electrocardiograph About the test types Auto ECG A report typically showing a 10 second acquisition of 12 leads of ECG information combined with patient data measurements and optional interpretation Auto ECGs can be saved to the electrocardiograph s test directory or to a USB mass storage device In CP 50 Plus models auto ECGs can also be sent to a Welch Allyn CardioPerfect workstation Stat ECG An auto ECG that starts instantly without waiting for you to enter patient data or adjust the waveforms Rhythm ECG A continuous real time printout of rhythm strips with a user defined lead configuration Rhythm ECGs are printo
30. ou can enter patient data automatically if it is available e The search button gives you access to patient data in the test directory or in a connected database CardioPerfect workstation or EMR e The Worklist button CP 50 Plus only gives you access to patient data in the worklist If a Waiting for 10 seconds of guality data message appears at least 10 seconds of ECG data have been collected with excessive artifact Minimize the artifact as described under Troubleshooting Then wait for the test to print If necessary you can override the wait time and print the available data immediately but the result might be an incomplete or poor quality test After the test prints select the desired option Reprint Save or Retest Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation DD MM YYYY eu 00 00 AM Reprint Print this test again o cn Discard this test and start over iJ A WARNING To avoid the risk of associating reports with the wrong patients make sure that each test identifies the patient If any report does not identify the patient write the patient identification information on the report immediately following the ECG test 26 ECG testing Welch Allyn CP 50 resting electrocardiograph 27 Administrative tasks Turning the security option on or off CP 50 Plus only The electrocardiograph incorporates security features that can keep patient d
31. patient cabl amp s uu vs yd Gent ee eee de Y EP DIOE 11 Loading the thermal paper FF cece lens 12 Powering the electrocardiograph 00000 eee 14 About the tM Gnu eie ae y e ek ate aude week EE I eed WR E P aui Res 15 Viewing or changing the settings liliis 16 Viewing the device information FYF I RR 16 Verifying proper operation assau es 17 Connecting to an external USB printer optional CP 50 Plus only 18 Connecting to a CardioPerfect workstation optiorial GP b0O Plus only zu iu t o bt ode S B peces eu 19 3s ECG testing o a th ey ALorem istic LE A EAR steal 21 Attaching the leads to the patient 0 000200 FF Y eee 21 Electrode locations oa iil win Avan satin Heaton tn eee ae dae dis ale Dd RE aa 23 Pertormingran EGG dest eu vec Waa es aede Rec RO e rt edes 24 4 Administrative tasks v sede Vx eta Ga bee RR AER A 27 Turning the security option on or off CP 50 Plus only 0 27 Managing the user list CP 50 Plus only 0 20 00 0c eee eee eee 28 Turning the audit trail on or off CP 50 Plus only Y 0000 ua 28 Managing the worklist CP 50 Plus only LLY cece eee eee 29 Managing thie test director ee eed Sos 29 5 Maintenance siccus we aa te bee NH E Se E PUDE E M E nd 31 Cleaning the ecguiprnent nemi TS Pak D IE md et d 31 Inspecting the eguipment L LILFFF FFY ss 32 Testing the electrocardiograph
32. r isopropyl alcohol or skin preparation pads 22 ECG testing Welch Allyn CP 50 resting electrocardiograph 4 Attach the lead wires to the electrodes 5 Apply the electrodes to the patient Electrode examples left to right arm clamp reusable Welsh cup reusable tab electrode disposable monitoring electrode disposable e For reusable electrodes Use electrode paste gel or cream to cover an area the size of each electrode but no larger Secure the arm and leg clamps Apply the Welsh cups suction electrodes to the chest e For disposable tab electrodes Place the electrode tab between the jaws of the connector Keep the tab flat Verify that the metal portion of the connector makes contact with the skin side of the electrode tab e For all disposable electrodes Lightly tug on the connector to ensure that the lead is securely attached If the electrode comes off replace it with a new electrode If the connector comes off reconnect it Directions for use Electrode locations ey ECG testing 23 AHA IEC Location A V1 C1 Fourth intercostal space at the right sternal border red red B V2 C2 Fourth intercostal space at the left sternal border yellow yellow C V3 C3 Midway between V2 and V4 green green D V4 C4 Fifth intercostal space to the left of the midclavicular blue brown line E V5 C5 Anterior axillary line at the same horizontal level as V4
33. raph into AC power as often as possible so that the built in charger can keep the battery charged Regardless of the battery condition you can use the electrocardiograph whenever it is plugged in A A WARNING When you use AC power always plug the electrocardiograph into a hospital grade outlet to avoid the risk of shock WARNING If the integrity of the building s safety ground is in doubt operate this device on battery power to avoid the risk of shock To power up or power down Press AC power indicator xy Battery indicator Directions for use Setup 15 About the menu The menu provides access to the saved patient tests the settings and the service functions From either of the main screens you can reach the menu by touching the menu button DD MM YYYY 00 00 AM DD MM YYYY os 00 00 AM aM A Delete print export or edit saved tests UM Add find delete or download patients Ulud Change ECG and system settings Sevke Access service functions Log out the current user 69 Menu CP 50 Plus example 16 Setup Welch Allyn CP 50 resting electrocardiograph Viewing or changing the settings Three types of settings are available e The ECG settings which control the content and format of your reports In CP 50 Plus models these settings include a second report format auto report 2 customizable patient data fields and auto save options
34. rned off or set incorrectly Actions e Verify that the patient is not touching any metal e Verify that the AC power cable is not touching the patient cable e Verify that the proper AC filter is selected e If 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 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 Lead alert or square wave A dot might be flashing on the lead status screen Or one or more leads might appear as a square wave PLL Causes Electrode contact might be poor A lead might be loose A lead might be defective Directions for use Troubleshooting 37 Actions Replace the electrode Verify that the patient s skin has been properly prepared Verify that electrodes have been properly stored and handled Replace the patient cable System problems The electrocardiograph won t turn on when it is plugged in Causes e The AC power connection is faulty e An AC fuse is blown e There is no AC power Actions e Check the AC power source e Check the AC fuses The electrocardiograph won t turn on when it is unplugged Causes e The battery is disconnected or incorrectly connected e The battery is low not charging depleted or bad Actions e Check the batte
35. ry connections e Recharge the battery e Replace the battery The electrocardiograph shuts down during printing Causes e The battery is low or bad Actions e Recharge the battery e Replace the battery The electrocardiograph prints fewer than 10 reports on a full battery charge Causes e The battery is degraded Actions e Replace the battery The electrocardiograph does not respond when you press buttons or touch the screen Causes e The electrocardiograph is frozen 38 Troubleshooting Welch Allyn CP 50 resting electrocardiograph Actions e Reset the electrocardiograph by pressing and holding the power button for at least six seconds until the screen goes blank Press the power button again The electrocardiograph goes through some diagnostic tests that cause it to take longer than usual to power up For more troubleshooting guidelines see the service manual Caution The service manual is for use only by qualified service personnel who understand technical English Directions for use Troubleshooting 39 Limited warranty Welch Allyn Inc warrants that the CP 50 and CP 50 Plus electrocardiographs the Products meet the labeled specifications of the Products and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase except that accessories used with the Products are warranted for 90 days after the date of purchase Such accessories include cables electrodes and bat
36. s Power button AC power indicator Auto ECG button Rhy f T gt m ECG button o Pressure point for closing the printer door Printer door latch Welchauyn v zu yn Eguipotential Ethernet connector RJ45 Mini USB connector terminal for PC functional on for PC CP 50 Plus only e USB connector for mass storage device printer AC power inlet AC fuses Mounting holes for the CP 50 mobile stand adapter optional E Battery door Directions for use Symbols Documentation symbols Introduction 5 Warning Warnings indicate conditions or practices that could lead to illness injury or death BA Consult operating instructions gt gt Caution Cautions indicate conditions or practices that could damage the equipment or other property Operation symbols Power on standby Auto ECG Accept Previous Help Backspace cogn Search Rhythm ECG Close Next Menu Power symbols aO tO l LED off No AC power is present LED green AC power is present and battery is fully charged LED amber AC power is present and battery is charging Alternating current Dangerous voltage Fuse Protective earth Equipotential terminal JOO 0g
37. st 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 return of your product 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 your product for service follow these recommended packing instructions e Remove all hoses cables sensors power cords and other accessories as appropriate before packing unless you suspect they are associated 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 41 Specifications Item Specification Dimensions including rubber feet length x height x width Weight Keyboard type power auto ECG and rhythm ECG buttons Display Type Resolution Thermal paper Z fold Roll Thermal printer internal Thermal chart paper speeds Gain settings Auto ECGs Rhythm ECGs Lead configurations Report formats internal printer Auto ECGs Rhythm ECGs Average cycl
38. t Address field enter the host IP address b Touch Ping Test The electrocardiograph pings the host c Touch Server Test The electrocardiograph connects to the server The electrocardiograph is ready to communicate with the workstation To set up the workstation see the instructions that came with the workstation connectivity software 21 ECG testing Attaching the leads to the patient Proper lead attachment is important for a successful ECG The most common ECG problems are caused by poor electrode contact and loose leads Follow your local procedures for attaching the leads to the patient Here are some common guidelines WARNING Electrodes can cause allergic reactions To avoid this follow the electrode manufacturer s directions To attach the leads to the patient 1 Prepare the patient e Describe the procedure Explain the importance of holding still during the test Movement can create artifact e Verify that the patient is comfortable warm and relaxed Shivering can create artifact e Put the patient in a reclining position with the head slightly higher than the heart and legs the semi Fowler s position 2 Select the electrode locations See the Electrode locations chart e Look for flat areas e Avoid fatty areas bony areas and major muscles 3 Prepare the electrode locations e Shave or clip the hair e Thoroughly clean the skin and lightly rub it dry You may use soap and wate
39. t uses radio frequency signals to operate minimize the interference 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 transporting or servicing 9 10 Introduction A Welch Allyn CP 50 resting electrocardiograph 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 11 Setup Connecting the patient cable A WARNING Do not allow the conductive parts of the patient cable electrodes or associated connections of defibrillation proof applied parts including the neutral conductor of the patient cable and electrodes to come into contact with other conductive parts including earth ground Otherwise an electrical short might result risking electric shock to p
40. tabilize to surrounding environmental conditions before using it Caution To prevent possible damage do not use sharp or hard objects to press the touch screen or the buttons Only use fingertips Caution Do not expose the patient cable to strong ultraviolet 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 stretched or stepped on Otherwise measurements might no longer be accurate and repair might be necessary Caution Using the eguipotential terminal for anything but grounding purposes may contribute to damage of the device Caution Use only parts and accessories including thermal paper that were supplied with the device and available through Welch Allyn The use of accessories other than those specified may result in degraded performance or unsafe use of this device Caution Portable and mobile RF communications eguipment can affect the performance of the electrocardiograph Caution The electrocardiograph meets the Class A reguirements of IEC 60601 1 2 regarding incidental emission of radio freguency 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 eguipment tha
41. tery 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 because 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 reguires 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 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 PA
42. uts only They cannot be saved 2 ds RO mey 0 3 150 Mtr Comte OL OLZO0 12 57 34 AM National Uniwersity Homa ICU Version O OD OD S001 G Auto ECG report example A 3 rows 4 columns B Patient data C ECG measurements D Automatic ECG interpretation optional E Report status label F Rhythm leads G Gain speed AC filter freguency range date and time software version device ID practice ID H Calibration pulse Meri m es Meme Doe Jobn X 1 Jens 20 menie 003 150 Mr Ort OUOL 2006 12 54 25 AM Rational University Hosptial ICU Version 01 00 00 01 Dew Rhythm ECG report example Directions for use Introduction 3 Features Pacemaker detection The software detects the possible presence of a pacemaker If you confirm that the patient has a pacemaker the ECG report includes no interpretation and it indicates that a pacemaker was detected Automatic ECG interpretation optional The optional MEANS interpretation algorithm developed by the University of Rotterdam in the Netherlands provides automatic analysis of ECG tests 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 4 Introduction Welch Allyn CP 50 resting electrocardiograph Controls indicators and connector
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