CardioPerfect PRO ECG Recorder - User Manual
Contents
1. Do not dispose of in trash for devices Consult operating instructions directions for use DFU A copy of the DFU is available on this website A printed copy of mt the DFU can be ordered from Welch Allyn for delivery within 7 m calendar days Id Global Trade Item Number Electromagnetic Compatibility When using the CardioPerfect PRO cardiograph electromagnetic compatibility with surrounding devices should be considered and evaluated The CardioPerfect PRO cardiograph complies with IEC 60601 1 2 limits for EMC DIR 80012763 Ver G 11 25 WelchAllyn CardioPerfect PRO ECG Recorder User Manual 1 About the CardioPerfect PRO Cardiograph The Welch Allyn CardioPerfect PRO Cardiograph is specifically intended for the recording of standard 12 lead electrocardiograms of patients The device is not suitable for direct cardiac application A CardioPerfect PRO system typically comes with the following components CardioPerfect PRO Cardiograph SE PRO 600 1200 Patient Cable RE PC or SE PC PC Interface Cable Prolink PRO 60023 24 25 CardioPerfect Workstation Software CPWS SW integral part of the cardiograph s safety features Using any other patient cable may compromise defibrillation protection as well as cardiograph performance The patient cable should be routed away from power cords and any other electrical equipment Failure to do so can result in AC power line frequency interference on the ECG trac2. Netherlands 31 202 061 360 Sweden 46 85 853 65 51 Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the problem When calling please be prepared to provide Product name and model number and complete description of the problem The serial number of your product if applicable The complete name address and phone number of your facility For out of warranty repairs or spare parts orders a purchase order or credit card number e For parts order the required spare or replacement part number s Repairs 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 return In case the 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 A Return Material Authorization RMA number must be obtained prior to any return Note Welch Allyn does not accept returned products without an RMA Packing Instructions If you have to return goods for service follow these recommended packing instructions e Remove all hoses cables sensors power cords and ancillary products
3. the relative humidity should be at least 30 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 Welch Allyn CardioPerfect PRO Cardiograph requires continued operation during power mains interruptions it is recommended that the Welch Allyn CardioPerfect PRO Cardiograph be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 23 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Electromagnetic Immunity The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Conducted RF 3 Vrms Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the Welch Allyn CardioPerfect PRO Cardiograph including cables than the recommended separation distance calculated from the equation applicable to the frequency of the trans
4. 600 samples sec SE PRO 1200 Signal bandwidth 0 05 to 250Hz Sampling Rate 1200 samples sec 80 gain accuracy after 5s 80 gain accuracy after 5s all leads connected 15 to 90 non condensing Operating altitude 170 to 4877 m 557 to 16000 ft Safety EMC and regulatory compliance Complies with ANSI AAMI EC11 and multi country versions of IEC 60601 1 60601 1 2 60601 1 6 60601 2 25 62304 62366 Medical Device Directive The CardioPerfect PRO cardiograph complies with the requirements of the Medical Device Directive 93 42 EEC and carries the 0297 mark accordingly Declaration of Conformity available upon request Discarding the Equipment Dispose of this product and its accessories according to local regulations Do not X dispose of as unsorted municipal waste For more specific disposal or compliance information go to www welchallyn com weee or contact Welch Allyn Technical Support at www welchallyn com about company locations htm DIR 80012763 Ver G 21 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual 5 Guidance and Manufacturer s Declarations The Welch Allyn CardioPerfect PRO Cardiograph needs special precautions regarding EMC and needs to be installed and put into Caution service according to the following EMC information provided Portable and mobile RF communications equipment can affect the Welch Allyn CardioPerfect PRO Cardiograph Electromagnetic Emissions The Welch Ally
5. The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE DIR 80012763 Ver G 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Ur is the AC mains voltage prior to application of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material
6. Welch Allyn CardioPerfect PRO ECG Recorder User Manual y zZ S Welch Allyn Inc 4341 State Street Road EC REP Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Skaneateles Falls NY Dublin Road 13153 USA Navan County Meath www welchallyn com Republic of Ireland 901047 CARDIOPULMONARY ECG SYSTEM REF 901095 ECG RECORDER C Goro DIR 80012763 Ver G Revision date 2015 05 Welch Allyn CardioPerfect PRO ECG Recorder User Manual US Federal law restricts this device to sale by or on the order Caution ofa physician Copyright Copyright 2015 Welch Allyn To support the intended use of the product described in this publication the purchaser of the product is permitted to copy this publication for internal distribution only from the media provided by Welch Allyn No other use reproduction or distribution of this publication or any part of it is permitted without written permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone 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 statement of intended use published in this manual Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Welch Allyn to provide accurate and up to date information to users and operat
7. You assume all responsibility for use of the Product with any hardware or software that does not meet the system requirements described in the Product documentation 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 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 THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY 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 DIR 80012763 Ver G 8 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Table of contents DAlElY and PLECAUUONS scnascacenteecciesandenenottncasdasocanetahenaceddedenalndtoesuiadscsenetetesndsideddectuhtenassaaneds 3 PCOS ONO ie cencinnec A en este eae bats att ep tana re ne nn er een 6 Warranty Service and Spare Parts ccccccseccccssecceceeseceeceeceeceeeeeesseeecesseee
8. 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 lt is recommended that all returned goods be insured Claims for loss or damage to the product must be initiated by the sender DIR 80012763 Ver G 7 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Limited Warranty Statement Welch Allyn Inc warrants that the Welch Allyn CardioPerfect Workstation computer based product you have purchased meets the labeled specifications of the Product and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase Accessories used with the Product are warranted for 90 days after the date of purchase 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 120 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
9. be necessary such as reorienting or relocating the Welch Allyn CardioPerfect PRO Cardiograph b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m DIR 80012763 Ver G 24 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Recommended separation distances between portable and mobile RF communications equipment and the Welch Allyn CardioPerfect PRO Cardiograph The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Welch Allyn CardioPerfect PRO Cardiograph as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter IE JE T T lw P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer These guidelines may n
10. ction of the PRO Recorder to the electrode leads which adhere to the patient for detection of cardiac 13 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Patient Cables signals SE PC IEC CLIP CLIP style connector 1 meter CLIP style SE PC IEC CLPL connector 1 3 meters SE PC AHA CLIP SE PC AHA CLPL CLIP style connector 1 meter CLIP style connector 1 3 meters Patient Cables RE PC IEC BAN Banana style connector 2 meter RE PC IEC BANL Banana style connector 2 meters RE PC AHA BAN Banana style connector 2 meter 08265 0000 UTILITY CART Plastic cart that the PC and associated hardware can sit upon RE SIM ECG SIMULATOR Simulator of ECG signals that allows the user to confirm operation of the PRO Recorder and CPWS system RE ELEC DISP ELECTRODES 50X BANANA CABLE a RE ELEC 20 DISPOSABLE ELECTRODES FOR BANANA CABLE 102992 ADDITIONAL PROTECTIVE EARTH Kit allows the CPWS system with GROUNDING KIT FOR PC AND TREADMILL PC and Treadmill to be compliant with IEC 60601 1 from a system perspective 08281 0000 LASER PRINTER CARDIOPERFECT Printer that is approved for use with CPWS 404008 CPWS FLEX ARM OPTION Mechanical holder for the PRO Recorder Allows better cable management and support of the recorder while it is in use DIR 80012763 Ver G 14 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual 2 Installation Before using the system the CardioPerfect PRO cardiograph need
11. e The patient cable supplied with the CardioPerfect cardiograph is an N caution or cardiograph during defibrillation Death or injury may occur from the electrical shock delivered by the defibrillator It is recommended to check the patient cable and PC interface cable Prolink for damage prior to the use of the system If damage exists do not use the cable contact your local Welch Allyn Sales Office or your authorized Welch Allyn dealer or distributor to have the cable replaced Do not touch the patient patient cable PC interface cable Prolink NwWarnino DIR 80012763 Ver G 12 25 WelchAllyn 1 1 CardioPerfect PRO ECG Recorder User Manual Accessories Your CardioPerfect PRO cardiograph allows the use of a broad range of accessories contact your local Welch Allyn Sales Office or your authorized Welch Allyn Dealer or Distributor NOTE All part numbers may not be available in all countries CPR UN UB D PC Based Resting ECG non interpretive software CPR UI UB D PC Based Resting ECG interpretive software CPR UN PC Based Resting ECG Excludes patient cables CPR UN5 PC Based Resting ECG Excludes patient cables 5 meter USB cable CPR UN EB PC Based Resting ECG CPR UN EB D PC Based Resting ECG includes patient cables and electrode set CPR UI EB D PC Based Resting ECG Adult interpretive software RE SW MEANS CPWS software disk with interpretation RE SW QT CPWS software disk dispersion option RE SW VCG CPWS sof
12. e and have it inspected by a qualified service person before using it again Clean the PRO ECG Recorder Unless the PRO ECG Recorder the device itself rather than the cables and electrodes comes in direct contact with a patient it is acceptable to clean the device on a routine basis according to your facility s protocols and standards or local regulations Patient contact with the device might require immediate cleaning The following agents are compatible with the PRO ECG Recorder e 70 percent isopropyl alcohol e 10 percent chlorine bleach solution N When cleaning the device avoid using cloths or solutions that Caution include quaternary ammonium compounds ammonium chlorides or glutaraldehyde based disinfectants 1 Slightly dampen a soft clean cloth with an acceptable cleaning solution or use a 70 percent alcohol pad to wipe the exterior of the PRO ECG Recorder Dry all components with a clean soft cloth or paper towel 2 Before you power on the PRO ECG Recorder again wait at least 10 minutes for all traces of liquid to evaporate DIR 80012763 Ver G 19 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Clean the cables 1 Slightly dampen a soft clean cloth with lukewarm soapy water or a neutral cleaner and clean the patient cable and PC USB interface cable 2 Dry all cables with a clean soft cloth or paper towel 3 Wait at least 10 minutes before powering on the PRO ECG Recorder again Di
13. eeessaeeeessaaeees 7 Limited Warranty Statement usssssnsesnenneeeennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnen 8 1 About the CardioPerfect PRO Cardiograph ccssssccseeeeeeseseeeesseeeeeeeeeeeesseeeeeeseennensees 12 1 1 FRC CC SSO CS nee ee ee em 13 2 MAS eA OU acca ite 2er eccise et aeieoeetdinat ceca ne E ee uaa oad dun casmeauecameenetsaees 15 To connect the cables to the PRO ECG Recorder ccceeccceceeeeeeeeeeeeeeeaeeeeeeneeseeesaees 16 To disconnect the cables from the PRO ECG ReCOrdel ccscecceeeseeeeeeaeeeeeeeeeeeeenaees 16 2 1 Connecting the patient cable to the electrode cceecececeeseeeeeeeeeeeeeeeeeeeaeeeeeeeeeas 17 3 VM ANTICS FV AIC Cai ur ceeds oe catenin eraseecteeaceteaetetsaneesndtcnataccs saacsessadeesassecienaeuoecnvecciwarstenccacesatenstees 19 Clean the equipment ccccccceescseccceeceeeeeeeeceeeeseeeeeeseeeeeeessseaesseeeeeeessaeesseeeeeeeessaaaaeeeseees 19 Clean the PRO ECG ReCOrdet cccccccsescceteeseeeceeeseeeceeseeeceeeeeetenseeeseeseeeeteseeeneageeeees 19 The following agents are compatible with the PRO ECG Recorder 02222200 19 Clean the CADIS Seren sad Enns nennen 20 Disinfect ING CADIES ssaniccccssneccdsaincdncstinetvvsatmarsnsssncsdbseanetdeldnaivaewinasdeatancidteaandindetiacddeasuncsdens 20 INSPECTING the equipment uu0222420000000n0 nennen nnnnnnnnnnnnnn nennen nnnnnnnnnnnnnnennnnnnen
14. es and the PRO ECG Recorder will occur DIR 80012763 Ver G 16 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual 2 1 Connecting the patient cable to the electrode Please refer to the table below for information on connecting the patient cable to the electrodes _ Type of connection Connection to electrode Banana Alligator clamp Make sure the metal part of the patient cable connector makes contact with the skin side of the electrode tab Resting ECG Oo O Lu je z 7 Q am im O Oo O Lu u O im x Lu DIR 80012763 Ver G 17 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Oo Q Lu je 7 cc hom O Oo O Lu S O im x Lu DIR 80012763 Ver G 18 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual 3 Maintenance Clean the equipment N Keep the PRO ECG Recorder reusable electrodes and the patient Warning cable clean Patient contact with contaminated equipment can spread infection The patient cables should be cleaned after each use and disinfected as needed AN Never immerse the PRO ECG Recorder or the patient cable in Caution liquid Never autoclave or steam clean the PRO ECG Recorder or the patient cable Never pour alcohol directly on the PRO ECG Recorder or the patient cable and never soak any components in alcohol If any liquid enters the PRO ECG Recorder remove the PRO ECG Recorder from servic
15. ge currents from each instrument Any combination of non medical electrical equipment should be evaluated by local safety personnel before put into service Multiple portable outlet sockets use without an isolation transformer is disapproved unless casual access for additional equipment is impeded or prevented Accessories Use of accessories other than those recommended by Welch Allyn may compromise product performance The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and replacement parts DIR 80012763 Ver G 6 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Warranty Service and Spare Parts Warranty 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 Assistance and Parts If the product fails to function properly or if assistance service or spare parts are required contact the nearest Welch Allyn Technical Support Center USA 1 800 535 6663 Canada 1 800 561 8797 Latin America 1 305 669 9003 South Africa 27 11 777 7555 European Call Center 353 46 90 67790 Australia 61 2 9638 3000 United Kingdom 44 207 365 6780 Singapore 65 6419 8100 France 33 1 55 69 58 49 Japan 81 42 703 6084 Germany 49 695 098 5132 China 86 21 6327 9631
16. hysician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment Like all electronic devices this cardiograph is susceptible to electrostatic discharge ESD Electrostatic discharge typically occurs when electrostatic energy is transferred to the patient the electrodes or the cardiograph ESD may result in ECG artifact that may appear as narrow spikes on the cardiograph display or on the printed report When ESD occurs the cardiograph s ECG interpretation may be inconsistent with the physician s interpretation Welch Allyn assumes no liability for failures resulting from RF interference between Welch Allyn medical electronics and any radio frequency generating equipment when these levels exceed those established by applicable standards Patient cables and PC connection cables are intended to be inserted and removed from the PRO ECG Recorder in a push pull motion Do not twist the cables Damage to the cables and the PRO ECG Recorder will Occur 3 25 Welch Allyn CardioPerfect N warnings DIR 80012763 Ver G PRO ECG Recorder User Manual Power strips multiple portable socket outlets are not allowed for use in connecting the medical electrical equipment or any accessories to ground unless used in concert with a medical approved isolation transformer During defibrillation the ECG signals displayed may show waveform artifacts and cannot be relied on as a true indicatio
17. mitter Recommended separation distance 35 d JWP Radiated RF 3 V m IEC 61000 4 3 80 MHz to 1 GHz 80 to 800 MHz WP Ei 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W and dis the recommended separation distance in meters 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 o 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 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 which the Welch Allyn CardioPerfect PRO Cardiograph is used exceeds the applicable RF compliance level above the Welch Allyn CardioPerfect PRO Cardiograph should be observed to verify normal operation If abnormal performance is observed additional measures may
18. n CardioPerfect PRO Cardiograph is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Welch Allyn CardioPerfect PRO Cardiograph uses RF energy only for its internal function Therefore its RF emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The Welch Allyn CardioPerfect PRO Cardiograph is suitable for use in all establishments other than domestic and may be used CISPR 11 in domestic establishments and those directly connected to the Harmonic emissions Class A public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is IEC 61000 3 2 heeded WARNING This equipment system is intended for use by Voltage fluctuations Complies healthcare professionals only This equipment system may flicker emissions cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures IEC 61000 3 3 such as re orienting or relocating the Welch Allyn CardioPerfect PRO Cardiograph or shielding the location DIR 80012763 Ver G 22 25 WelchAllyn Electromagnetic Immunity CardioPerfect PRO ECG Recorder User Manual
19. n of the patient s physical condition Accessible metal parts such as electrode terminations should not come in contact with other electrically conductive parts including earth ground Welch Allyn provides a number of high quality patient leads in varying termination styles Use of these approved patient leads is required for electrical protection of the patient during cardiac defibrillation CardioPerfect devices are not intended for direct cardiac application An inoperable or damaged electrocardiograph can be identified by abnormal signals on the ECG waveforms Abnormal signals are characterized by flat lines excess noise square waves or other non typical anomalies that appear on the ECG waveform The electrocardiograph can be periodically tested by connecting the CardioPerfect to an ECG simulator Follow manufacturer s instructions lf there is a requirement for equipment to be connected to a personal computer or other non medical rated equipment it is the responsibility of the user to ensure that the electric power circuit to which the CardioPerfect system is connected includes an additional protective earth ground or an isolation transformer in order to satisfy the IEC 60601 1 safety standard 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 electrocardiogra
20. nnnnnnennnnn 20 Testing the electroCardiOgrap cccccccssscccceseeecsesececceseeecsaseeecsageeeeseseeessageeessageeesseass 20 4 Technical Specifications zu anne aaa a ne anna 21 Safety EMC and regulatory compliance uuus02200400eennnnnnnnnnnnennnnnnnnnnnnnnnnnnennnnne nenn 21 Discarding the Equipment een een 21 5 Guidance and Manufacturer s Declarations 2 20022002000n0nnunnn0nnunnnunnunnnunnunn nen 22 DIR 80012763 Ver G 9 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Conventions A safety symbol used on the device to highlight the fact that there are specific warnings or precautions associated with the device which are not otherwise found on the device label A WARNING in this manual indicates conditions or practices that if not corrected immediately could lead to illness injury or death A CAUTION in this manual indicates conditions or practices that if continued or not corrected immediately could damage the equipment NOTE A NOTE in this manual contains additional information on cardiograph usage IPXO Ingress Protection Not protected against the ingress of water Serial Number Product Identifier Defibrillation Proof Type CF applied part Manufacture Date YYYY MM DD CE Mark for Class Is Im Ila IIb amp Ill 297 0 Temperature Range DIR 80012763 Ver G 10 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual
21. ors alike Welch Allyn CardioPerfect Workstation and SpiroPerfect are registered trademarks of Welch Allyn Software in this product is Copyright 2015 Welch Allyn 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 provided on the original distribution medium The software may not be copied decompiled reverse engineered disassembled or otherwise 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 The information contained in this manual is subject to change without notice All changes will be in compliance with regulations governing manufacture of medical equipment User responsibility This product is designed to perform in conformity with the description thereof contained in this manual and accompanying labels and inserts when assembled operated maintained and repaired in accordance with the instructions provided A defective product should not be used Parts that are broken plainly worn missing or incomplete distorted or contaminated should be replaced immediately Should any repair or replacement become necessary we recommend that service be performed at the nearest approved service center The user of the product shall have the sole res
22. ot apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people DIR 80012763 Ver G 25 25
23. ph signal The electrocardiograph has not been designed for use with high frequency HF surgical equipment and does not protect against hazards to the patient Fire and explosion hazard Do not operate the electrocardiograph in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide in oxygen enriched environments or in any other potentially explosive environment 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 Consult your facility s equipment cleaning procedures when performing ECG testing on patients with open infectious sores 4 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Ensure the location of the electrode and associated cables provides maximum separation away from all sources of high frequency energy The best way to ensure patient safety is to completely remove all electrodes and cables from the patient when exposed to high frequency energy No modification of this equipment is allowed DIR 80012763 Ver G 5 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Patient and Operational Safety The cardiograph isolates all connections to the patient from electrical ground and all other conductive circuits in the cardiograph This reduces the possibility of hazardous currents passing from the ca
24. ponsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration by anyone other than Welch Allyn or their authorized service personnel Accessories The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and replacement parts Use of accessories other than those recommended by Welch Allyn Caution 2y compromise product performance DIR 80012763 Ver G 2 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual Safety and Precautions AN caution DIR 80012763 Ver G Radio Frequency RF interference between the PRO ECG Recorder or cardiograph and any existing RF transmitting or receiving equipment at the installation site including electrosurgical equipment in close proximity to the cardiograph should be evaluated before the equipment is operated as they may seriously degrade performance The CardioPerfect Cardiograph is susceptible to interference from RF energy sources lowered RF immunity which exceed the IEC 60601 1 2 limits such as power line bursts other medical devices cellular products information technology equipment and radio television transmission To reduce EMC interference the cardiograph shall be separated from the emitting source as much as possible If assistance is needed call your local Welch Allyn service representative Artifact on the ECG caused by electromagnetic interference should be evaluated by a p
25. rdiograph through the patient s heart to ground To ensure the patient s safety and your own please observe the following When integrating CardioPerfect devices with non medical rated equipment such as a computer the addition of an additional protective earth ground or the use of a medically approved isolation transformer is required for compliance to the IEC 60601 1 Medical System Safety Standard Any system components e g treadmill personal computer ergo meter that require to be connected to an outlet socket shall use only grounded power cords three wire power cords with grounded plugs Also make sure the outlet accepts the plug and is grounded Never adapt a grounded plug to fit an ungrounded outlet by removing the ground prong or ground clip Do not connect Multiple Portable Socket Outlets MPSO s or extension cords to the system Do not connect items which are not part of the system The use of multiple portable socket outlets and other non medical electrical equipment poses a safety hazard Refer to the Medical System Safety Standard IEC 60601 1 for the requirements of such attachments Multiple portable outlet sockets shall not be placed on the floor Multiple portable outlet sockets or extension cord shall not be connected to the system Do not connect items which are not part of the system The use of multiple non medical electrical equipment connected to the same patient may pose a safety hazard due to the summation of leaka
26. s to be connected to the computer and the software must be properly configured Figure 1 Front view CardioPerfect PRO Cardiograph Patient Cable Type CF Power on PC Interface Cable Connection Defibrillation Standby PC Symbol Connection proof LED button LED Figure 1 is a front view of the CardioPerfect PRO cardiograph A description of the items indicated is given in table 1 Table 1 Description of CardioPerfect PRO Cardiograph front panel DESCRIPTION EXPLANATION Patent Cable Connection Connection for the patient cable Type CF Symbol IEC symbol type CF equipment defibrillation proof Defibrillation proof Power on Standby button The Power on Standby button only applies to older devices Do not use this button LED e No LED a disconnected device that cannot record an ECG e Green a good USB connection and sufficient power to record an ECG PC Symbol Input for computer cable PC Interface Cable Connection for the PC interface cable Prolink Connection Before you can start recording ECG s with the CardioPerfect PRO cardiograph you need to 1 Install the applicable software refer to the Welch Allyn CardioPerfect Workstation Installation User Manual 2 Install the hardware including the required drivers Please refer to the Resting ECG manual chapters 11 amp 12 or Stress manual chapters 10 amp 11 3 Configure the software Please refer to the Resting ECG manual chapters 11 amp 12 or Stress manual chap
27. sinfect the cables When disinfection is required use chemical disinfectants containing ethanol 70 80 propanol 70 80 or aldehydes 2 4 Disinfect according to your facility s protocols and standards or local regulations N i Do not use these agents for routine cleaning of the cables Alcohol Caution can cause the plastic to become brittle and may cause the cable to fail prematurely Inspecting the equipment Perform the following inspections daily e Check for cracks or breaks in the PC USB interface cable the patient cable the patient electrodes and the PRO ECG Recorder 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 Whenever the electrocardiograph is serviced or whenever problems are suspected verify continued electrical safety of the device using IEC 60601 1 or ANSI AAMI ES methods and limits AN Only qualified service personnel should perform leakage current Warning tests Test for the following e Patient leakage current e Chassis leakage current e Earth leakage current DIR 80012763 Ver G 20 25 Welch Allyn CardioPerfect PRO ECG Recorder User Manual 4 Technical Specifications Table 2 CardioPerfect PRO Cardiograph SE PRO 600 Signal bandwidth 0 05 to 150Hz Sampling Rate
28. ters 10 amp 11 DIR 80012763 Ver G 195 25 WelchAllyn CardioPerfect PRO ECG Recorder User Manual Figure 2 PC cable Prolink Latch release alignment key Figure 3 Patient cable The Prolink cable has 2 alignment keys and the Patient cable has 1 alignment key To connect the cables to the PRO ECG Recorder 1 Hold the PRO ECG Recorder in one hand hold the Cable connector with your other hand 2 Align the alignment keys with the notches in the corresponding PRO ECG Recorder receptacle 3 Push the cable gently into the PRO ECG Recorder receptacle until it latches To disconnect the cables from the PRO ECG Recorder 1 Hold the PRO ECG Recorder in one hand hold the Cable connector with your other hand 2 Gently pull the latch release away from the PRO ECG Recorder handled with care Improper use could result in inoperable ECG and The PRO ECG Recorder including connectors and cables should be werning or compromising patient safety Do not drop the PRO ECG Recorder this may result in mechanical failure Make sure the connectors are properly aligned before mating with the PRO ECG Recorder Do not use force to insert the cables into the PRO ECG Recorder receptacles Never pull the cables only the latch release AN Patient cables and PC connection cables are intended to be Caution inserted and removed from the PRO ECG Recorder in a push pull motion Do not twist the cables Damage to the cabl
29. tware disk vector option RE SW RR UPG UN UC D T CPWS software disk upgrade from resting to stress CCW UPCPWR CPWS software disk upgrade from DOS Windows UPDT WACPW CD CPWS software disk update from older CPWS versions CPWS software disk update from older versions UPDT WACPW OW CPR UPG LTU normal resting functionality MDR to normal resting functionality SE PC IEC PUSH SE PC IEC PSHL DIR 80012763 Ver G CPWS software disk interval option out of warranty only CPWS software disk upgrade from resting lite resting ECG to normal ECG functionality Patient Cables PUSH style connector 2 meter PUSH style connector 1 3 meters The Welch Allyn CardioPerfect PRO Cardiograph is specifically intended for the recording of standard 12 lead electro cardiograms of patients The device is not suitable for direct cardiac application Software upgrade from normal resting algorithm to include indicated data analysis options These options allow data analysis by different methods Software enables user to view and save electro cardiograms of patients on a PC Software upgrade from originally purchased CPWS Software enables user to view and save electro cardiograms of patients ona PC Clips allow user to connect banana jack terminated patient leads to electrode tabs needing alligator clip attachment Cable allows connection of the PRO Recorder to the PC USB connector Cable allows conne
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