MAC™ 400 Resting ECG Analysis System Safety and Warnings Guide
Contents
1. 1 Use the up down cursor to select Notation 2 Use the _ right left cursor to select AHA or IEC 3 Press enter to confirm your selection C Setting the date and time Set the date and time for printed ECG reports To set the date 1 Use the up down cursor to select Date gt 2 Usethe _ right left cursor to set the date 3 Press enter to confirm your selection To set the time 1 Use the _ up down cursor to select Time 2 Usethe _ right left cursor to set the time 3 Press enter to confirm your selection D Selecting heart rate limit values 1 Use the _ up down cursor to select HR control The cursor flashes on the low limit value 2 Use the amp right left cursor to change the low limit value in increments of 5 BPM between 30 and 120 BPM 3 Press enter to confirm your selection 4 Use Eh right left cursor change the high limit value between 80 and 240 BPM 5 Press enter to confirm NOTE After setting these options you must press WT configuration to save the options and exit the setup menu Heart rate indication THE BASICS WARNING PATIENT HAZARD The MAC 400 system is not intended for use as a vital signs physiological monitor When needed use a device intended for vital signs monitoring When the heart rate indication function is enabled the automatic switchoff is disabled Conditions of high and low heart rate are indic2. Improper printing Battery error CE 0459 Interference from the power line Muscle artifact caused by patient movements hiccup coughing Built in lithium ion battery is depleted The battery has a life of approximately 5 years Defective AC power adapter or fuse Paper compartment not properly closed The paper pad was inserted in the wrong direction so that the cue marker cannot be identified Adhesion of dust and foreign materials to paper can deteriorate the life of the printer head and plate Internal system temperature may be higher than the recommended battery charging range Faulty battery Solution Ground bed verify position of the lead wires switch on the AC filter The patient should be warm and resting comfortably place cushions under arms and knees Enable muscle filter 20 Hz 35 Hz if necessary Notify service to check the battery Notify service to check the fuses Printer door must lock into place on both sides Insert the paper pad as instructed in the MAC 400 Resting ECG Analysis System Installation and Setup Guide Clean the printhead as indicated in this guide restart recording in battery mode We recommend recording ECGs in battery mode and charging the battery when the system is not in use Notify service to check the battery Switch off the mains and MAC 400 Resting ECG Analysis System Maintenance Guide
3. 2007 2008 General Electric Company All rights reserved BASELINE ROLL PROBLEM The MAC 400 system is equipped with automatic baseline adjustment and anti drift system ADS to ensure artifact free recording At the beginning of the recording the automatic baseline adjustment verifies the incoming signal and adjusts the baseline position accordingly During recording the anti drift system continuously checks the baseline position and returns the baseline to its normal level See Figure 1 If electrodes are not properly applied these measures may not fully compensate for artifact Electrodes applied without conductive gel may induce high polarization voltages that can cause the amplifier to overrange A straight line is recorded instead of the ECG see Figure 1 ADS returns this line to its normal position and a baseline ensues for approximately one second figure 1 SOLUTION e Apply the electrodes according to instructions e Do not apply the electrodes on top of clothing e Use a contact agent moist electrode paper electrode cream spray etc e Wait approximately 10 seconds before initiating a recording The polarization voltages stabilize if the electrodes are properly applied If not the electrode concerned is indicated on the display R RA L LA F LL C1 V1 to C6 V6 NOTE The system does not support lead fail indication for the N RL electrode If the ECG is extremely noisy the N RL electrode may not be properly
4. SERVICE REQUIREMENTS Refer equipment servicing to GE authorized service personnel only Any unauthorized attempt to repair equipment under warranty voids that warranty It is the user s responsibility to report the need for service to GE or an authorized agent EQUIPMENT IDENTIFICATION Every GE device has a unique serial number for identification on the device label HHH HH HH HHHA A B C F E Product code is SCT Year manufactured 00 99 00 2000 01 2001 and so on Fiscal week manufactured Oon D Production sequence number F Miscellaneous characteristic Asian Headquarters GE Medical Systems Information Technologies Asia ee eer GE Medical Systems Information Technologies Inc 8200 West Tower GE Medical Systems GE China Co Ltd Avenue Information Technologies 11th Floor Shanghai MAXDO Milwaukee WI 53223 USA GmbH Centre 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 People s Republic of China Tel 86 21 5257 4650 Tel 1414 355 5000 Munzinger Strabe 3 5 1 800 558 5120 US only D 79111 Freiburg Fax 1414 355 3790 Germany Tel 49 761 4543 0 www gehealthcare com Fax 49 761 4543 233 CE MAC 400 resting ECG analysis system guides 2 of 7 2032589 001 Revision E 0459 The MAC 400 Resting ECG Analysis System Installation and Setup Guide provides instructions for initial installation and setup of your system Before you begin Remove the device and ac
5. beeps Cabrera lead sequence KEDE ai with every detected systole aVL L aVR II aVF III V1 60 for countries with 60 Hz Simultaneous collects and saves 12 standard Filter frequency Selection of muscle filter DD MMM YYYY Seq Sequential leads for 10 seconds The leads only if muscle frequency NOTE filters may ee Ee eer filter is ON suppress diagnostically 24 hour format e g Adjust with cursor right left 17 50 HH MM press the enter key to confirm Only enable filters when n OP IONAL Phor Long ai a eee TE O CIRE necessary Factory defaults Yes Select Yes to restore the aan same poniga oi tine long Dr No default always factory default settings reports only format 10 seconds short ADS Anti Drift On Off In case of wandering baselines leads each relevant portions of the signal and save format 3 seconds System restores the baseline to its remains as no Lead fail indicator to V6 power line Date Chinese language Change the date Adjust with o V6 i Muscle filter Suppression of muscle artifact YYYY MM DD cursor right left press the Heart rate in beats per minute BPM Report format Sim In automatic mode the system Off All other languages enter key to confirm and save Hz top AC filter line frequency in Hertz Hz Sih 5 7 a 7 T TETT original position ADS causes Print configuration Yes Select Yes to print a list of Hz bottom Muscle filter in Hertz Hz Hi es
6. connected Check and reconnect If it becomes necessary to verify the raw ECG signal switch off the ADS function and all filters 35 Hz 20 Hz muscle filter AC filter Activate the AC line filter 50 Hz 60 Hz in the presence of strong AC line interference ee ee figure 2 MAC 400 resting ECG analysis system guides 2032589 001 GE Medical taal Systems Information Technologies Inc 8200 West Tower Avenue Milwaukee WI 53223 USA Tel 1414 355 5000 1 800 558 5120 US only Fax 1414 355 3790 www gehealthcare com oo GE Medical Systems Information Technologies GmbH Munzinger Strabe 3 5 D 79111 Freiburg Germany Tel 49 761 4543 0 Fax 49 761 4543 233 Asian Headquarters GE Medical Systems Information Technologies Asia GE China Co Ltd 11th Floor Shanghai MAXDO Centre 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 People s Republic of China Tel 86 21 5257 4650 7 of 7 Revision E
7. filter on off 5 If required use the lead selection to change the lead oe lead group or the _ cursor keys to modify other settings NOTE For details on changing settings see the MAC 400 Installation and Setup Guide 6 Wait for the patient to lie motionless and press o start stop to initiate signal acquisition and recording Operating modes The MAC 400 system has three operating modes for recording ECGs Once you determine the mode you want to use and adjust the settings follow the operating instructions NOTE The factory default sets the heart rate HR indication function active in all operating modes The default HR limits are 45 BPM and 30 BPM These limits can be changed from the setup menu At least four QRS complexes are required for correct determination of the heart rate AUTOMATIC MODE The default operating mode for the system is automatic mode When initiated in automatic mode the system simultaneously acquires 12 leads of ECG for a period of 10 seconds and then recording proceeds automatically The system measures the ECG and records the results on a report You can choose between simultaneous and sequential report formats e Simultaneous format records all leads representing the same period of time either 10 seconds long format or 3 seconds short format e For sequential recordings the 10 second signal acquisition period is divided into four segments of 2 5 seconds each The first
8. to verify equipment compatibility Disposable devices are intended for single use only Do NOT reuse as performance may degrade or contamination could occur Disposables Equipment damage Devices intended for emergency application must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site Wait until all moisture has vaporized before using the device Electric shock To reduce the risk of electric shock do NOT remove PASIAN _ cover ran ats Power Before connecting the device to the power line check requirements that the voltage and frequency ratings of the power line are the same as those indicated on the unit s label If not do not connect the system to the power line This equipment is suitable for connection to public mains as defined in CISPR 11 Low battery shut If the battery is not charged for a long enough period down of time or after multiple attempts to power on following a low battery shut down the system shifts to a second level of deep discharge protection If device is turned on it might call for a 1 to 2 minute continuous self test Charge the battery for a minimum of half an hour before using device We recommend that you keep the unit charged to avoid a low battery shut down This equipment contains no user serviceable parts Refer servicing to qualified service personnel Supervised use This equipment is intended for use under the direct
9. R intervals Between events you may initiate a 10 second recording with the f copy key NOTE In arrhythmia mode the heart rate indication function is always active and cannot be disabled Silence the audio signal emitted when the heart rate exceeds either limit by pressing m49 QRS beep NOTES FOR MANUAL AND ARRHYTHMIA MODE ECGS The following conditions apply to the system when operating in either manual or arrhythmia mode e If you change the paper speed gain lead group or filter settings during a recording the system briefly stops advances the paper to the next fold or a few millimeters and then resumes recording These settings can not be changed for the first two pages of recording in arrhythmia mode e Information can be lost following a change of device settings e Ifthe ADS Anti Drift System is enabled there is a short delay to activate this function before recording starts Report documents The length and scope of the reports can vary depending on the operating mode and selected lead and report format MEASUREMENT RESULTS Following the ECG recording the system prints one page of measurement results including patient information and recording details INTERPRETIVE STATEMENTS OPTIONAL With the interpretive statements option active the system prints an interpretive statement after the measurement results Since it is not possible to enter a patient s age the data is interpreted as an adult ECG For a detail
10. TORING THERMAL PAPER NOTE To ensure maximum image life store thermal paper separately in manila folders or polyester polymide protectors To avoid deterioration or fading follow these precautions 1 Store in cool dark and dry locations Temperature must be below 86 F 30 C Relative humidity must be less than lt 65 2 Avoid exposure to bright light or ultraviolet sources such as sunlight fluorescent and similar lighting which causes yellowing and fading 3 Do NOT store thermal papers with any of the following e Carbon and carbonless forms e Non thermal papers or any products containing tributyl phosphate dibutyl phthalate or other organic solvents Many medical and industrial writer papers contain these chemicals e Document protectors envelopes and sheet separators containing polyvinyl chloride or other vinyl chlorides 4 Avoid contact with cleaning fluids and solvents such as alcohols ketones esters ether etc 5 Do NOT use mounting forms pressure sensitive tapes or labels containing solvent based adhesives Technical inspection For safety the equipment requires regular maintenance To ensure functional and operational safety of the device technical inspections should be performed annually by persons with adequate training and experience These checks can be carried out by GE within the framework of a service contract Inspections include the following checks e Visual inspection of equipment and a
11. The MAC 400 Resting ECG Analysis System Safety and Warnings Guide provides guide details safety information and symbols definitions Guides information The MAC 400 Resting ECG Analysis System Guides contain the instructions necessary for operating the MAC 400 system in accordance with its function and intended use The information in these guides only applies to MAC 400 system software version 1 It does not apply to earlier software versions Due to continuing product innovation specifications in these guides are subject to change without notice MAC and Mactrode are trademarks owned by GE Medical Systems Information Technologies a General Electric Company going to market as GE Healthcare All other marks are owned by their respective owners INTENDED AUDIENCE The MAC 400 Resting ECG Analysis System Guides are intended for persons who use maintain or troubleshoot this equipment REVISION HISTORY The document part number and revision letter are on the bottom of each page The revision letter identifies the document s update level Revision History 2032589 001 B_ 15 ane 2007 Revised per MVP Feedback D H Sepiember 2007 Revised heade Updated Equipment Symbols PRODUCT REFERENCE The product described in these guides is the MAC 400 resting ECG analysis system It may be referred to as the system throughout these documents CONVENTIONS These conventions are used in the MAC 400 system guides Bold t
12. ased on environmental conditions Do NOT use excessive drying techniques such as oven forced heat or sun drying STORING CABLES AND LEAD WIRES e Store in a dry well ventilated area e Vertically hang cables and lead wires e Do not coil lead wires or cables tightly around the device CLEANING AND DISINFECTING ELECTRODES Clean reusable electrodes immediately after use on a patient 1 Peel off the adhesive foil before cleaning the electrodes any extra adhesive can be removed with benzene 2 Use warm water and a small brush to remove cream or gel Do not use pointed or sharp objects for cleaning 3 Disinfect the electrodes with alcohol free disinfectant Ensure that connectors and sockets do not get wet NOTE Discard disposable adhesive electrodes immediately after use Do NOT reuse STERILIZING ELECTRODES The only approved sterilization method is gas sterilization Sterilize with ethylene oxide gas EtO at a maximum temperature of 50 C 122 F After EtO sterilization follow the manufacturer s recommendations for required aeration NOTE Frequent sterilization reduces the useful life of cables and lead wires Printer maintenance CLEANING THE PRINTHEAD If the printer is not functioning properly you may need to clean dust and foreign particles from the printhead To clean the printhead 1 Separate the platen from the printer 2 Gently wipe off the heating element part of the surface with cotton swabs and ethyl alcoho
13. ated in all operating modes even when not recording This function can be disabled in the setup menu The default heart rate limits are 45 and 730 BPM and can be modified in the setup menu If the heart rate exceeds one of the set values the system emits an audio signal This audio signal ceases automatically when the heart rate returns to the permitted range or when you press QRS beep The audio signal will not recur if it was silenced with QRS beep The audio signal recurs only when the heart rate exceeds one of the limit values again MAC 400 resting ECG analysis system guides 2032589 001 E Hooking up the starter kit Once you have customized your settings connect the patient cable to the device A on the right side panel Default settings for auto mode When you turn on the device the system default is automatic mode Factory defaults have the following functions and settings the most important settings are indicated on the display A B C D E Lead sequence Standard Einthoven I II III Goldberger aVR aVL aVF Wilson 1 V1 V2 V3 Wilson 2 V4 V5 V6 Lead fail indicator Indicates a disconnected electrode For example LA indicates that the left arm electrode is disconnected Heart rate Detects the patient s heart rate In this example it is 60 BPM AC filter On enabled 50 Hz Muscle filter Off disabled Sensitivity gain 10 mm mV Paper speed 25 mm s Rotating s
14. ccessories for signs of mechanical damage that may impair the device functions e Visual inspection of the device labeling for legibility e Functional test as described in the service manual e Measurement of the resistance of the non fused earthed conductor and the equivalent leakage current as per local regulations MAC 400 resting ECG analysis system guides 2032589 001 NOTE The device does not require any other maintenance Order information Always refer to the most recent list of accessories For a complete list of MAC 400 system supplies and accessories go to www gehealthcare com Disposal of the product The product described in this guide must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment WARNING EXPLOSION HAZARD Batteries may explode in fires Do not dispose of the battery by fire or burning Follow local environmental guidelines concerning disposal and recycling Error messages Message Paper Error The system is out of Check paper supply paper Remove jammed paper Paper jam Set up the system for correct Wrong paper type paper type inserted z fold roll Clear message with 141 Close printer door correctly Clear message with TIM Door Open Printer door not closed properly Battery Error Battery not present Check for bat
15. cessories from the box and keep on a flat dry surface away from direct sunlight heat sources amp dust mas Hete TAFT Eag j SFM A Confirming the box contents e MAC 400 resting ECG analysis device e Four limb clamp electrodes e Six bulb electrodes e Patient ECG cables lead wires e Power cable e Pack of z fold paper 280 sheets e Electrode cream e CD containing a service manual and 12SL Physicians Guide e User guide B Charging the battery The MAC 400 system needs a charged battery to print an ECG Charge the battery for three hours for full power A fully charged battery allows for 100 automatic mode ECGs or 100 minutes of arrhythmia manual mode recording 1 Connect the device to a power source 2 Turn on the power a green light indicates that AC mains is connected 3 After charging for three hours unplug the power cord from both the device and the power source Recharge when you see a yellow light above the power key C Loading paper The MAC 400 system supports the use of standard thermal recording paper in either z fold pads or roll paper 1 Locate the printer assembly 2 Gently pull back the printer assembly door to open the door latch 3 Open the z fold paper pack 4 Ensure that the black paper guide is on the top and place the paper in the tray 5 Advance the first sheet and close the door Make sure that the paper is positioned on the pressure roller and that the door lock
16. discharge RECORDING ECGS OF PACEMAKER PATIENTS The system does not support pacer pulse detection WARNING PATIENT HAZARD If several adverse conditions exist at once pacer pulses might be interpreted and counted as QRS complexes Pacemaker patients should always be watched closely ACCURACY OF THE INPUT SIGNAL REPRODUCTION e Overall system error is tested using the method described in AAMI EC11 3 2 7 1 Overall system error is 5 e Frequency response is tested using the method described in AAMI EC11 3 2 7 2 methods A and D MODULATING EFFECTS IN DIGITAL SYSTEMS This device uses digital sampling techniques that may produce some variation in amplitudes of Q R and or S waves from one heart beat to the next These variations may occur more in pediatric recordings If this variation 1s observed be aware that the origin of amplitude variations is not entirely physiologic For measuring voltages of Q R and S waves use the QRS complexes with the largest deflection of the particular waves PARTS AND ACCESSORIES To ensure patient safety use only parts and accessories manufactured or recommended by GE Parts and accessories must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards EQUIPMENT SYMBOLS Description Function Type CF equipment The acquisition module is protected from defibrillation shocks The flashing yellow LED indicates you must connect to AC power to re c
17. djustments modifications or repairs are carried out by persons authorized by GE e The electrical installation of the relevant room complies with the requirements of the appropriate regulations e The equipment is used in accordance with the instructions for use INTENDED USE The MAC 400 device is for use under the direct supervision of a licensed healthcare practitioner The system is intended to acquire measure and record information from adult and pediatric populations The basic system delivers 3 channel ECG recordings in automatic and arrhythmia modes and 1 or 3 channel ECG recordings in manual mode The arrhythmia detection provides the convenience of automatic documentation It is not designed to provide alarms for arrhythmia detection This system is not intended for use as a vital signs physiological monitor or for use during patient transport This device is not intended for use with high frequency surgical units Disconnect the patient from the device before using the high frequency surgical units This device is not intended for use with direct cardiac applications BIOCOMPATIBILITY The parts of the product described in these guides including all accessories that come in contact with the patient during the intended use fulfill the biocompatibility requirements of the applicable standards Please contact GE or its representatives with any questions Safety information DEFINITIONS The terms danger warning and caution are us
18. ed description of the ECG measurement and interpretation program refer to the 2SL Physician s Guide Asian Headquarters GE Medical Systems wal GE Medical Systems Information GE Medical Systems Information Technologies Asia Technologies Inc Information Technologies GE China Co Ltd 8200 West Tower Avenue GmbH 11th Floor Shanghai MAXDO Milwaukee WI 53223 USA Centre Munzinger Strabe 3 5 D 79111 Freiburg Germany Tel 49 761 4543 0 Fax 49 761 4543 233 Tel 1414 355 5000 1 800 558 5120 US only Fax 1414 355 3790 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 People s Republic of China www gehealthcare com Tel 86 21 5257 4650 5 of 7 Revision E The MAC 400 Resting ECG Analysis System Maintenance Guide provides maintenance and troubleshooting details for the device Cleaning and disinfecting exterior surfaces Clean and disinfect exterior surfaces monthly or more often as needed To clean exterior surfaces 1 Use a clean soft cloth and an agent or disinfectant that contains alcohol and is commonly used in hospitals NOTE Do not use disinfectants with a phenol base or peroxide compounds 2 Wring excess water solution from the cloth Do NOT drip water or any liquid on the device and avoid open vents plugs or connectors 3 Dry surfaces with a clean cloth or paper towel Patient cables and lead wires maintenance Clean and disinfect cables and lead wires as spec
19. ed in these guides to point out hazards and to designate a degree or level of seriousness Familiarize yourself with their definitions and significance A hazard is defined as a source of potential injury to a person DANGER indicates an imminent hazard which if not avoided will result in death or serious injury WARNING indicates a potential hazard or unsafe practice which if not avoided could result in death or serious injury CAUTION indicates a potential hazard or unsafe practice which if not avoided could result in personal injury or product property damage NOTE provides application tips or other useful information to ensure that you get the most from your equipment The safety information given in this manual is classified as follows Warning Description Accidental spills To avoid electric shock or device malfunction liquids must not enter the device If liquids enter the device stop using it and have it checked by a service technician before further use Battery If the integrity of the protective earth conductor is in Cables To avoid possible strangulation route all cables away eS tempat Connection to This is Class I equipment The mains plug must be Warning Do not come into contact with patients during defibrillation Serious injury or death could result Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages To ensure proper defibri
20. ed when a patient cable is connected Copy key press to print additional report copies QRS beep key Press to enable disable QRS beep and audio signals alerting to specific events and to clear the error message Asian Headquarters t GE Medical Ec ner GE Medical Systems i i i Systems Information Technologies Configuration key press to access quit setup menu n GE Medical Systems Aa CE GA C Technologies Inc Information Technologies 14th Floor Shanghai 8200 West Tower Avenue GmbH MAXDO Centre Milwaukee WI 53223 USA Munzinger Strabe 3 5 8 Xing Yi Road Hong Qiao Tel 1414 355 5000 D 79111 Freiburg Development Zone a 1 800 558 5120 US only Germany Shanghai 200336 People s System menu descriptions Fax 1414 355 3790 Tel 49 761 4543 0 Republic of China Fax 49 761 4543 233 ER IEIET NOTE Angular brackets identify default setting aa Tel 86 21 5257 4650 Language English Chinese Select a language for the French Dutch display and printed reports www gehealthcare com Italian Spanish NOTE When you choose Portuguese Russian Chinese or Russian changes Polish Czech only affect printed reports The Hungarian German display remains in English CE MAC 400 resting ECG analysis system guides 4of7 0459 2032589 001 Revision E The MAC 400 Resting ECG Analysis System Operator Guide provides instructions for using the device to record ECGs Before recording an ECG you must prepare the pa
21. ext Indicates keys on the keyboard text to be entered or hardware items such as keys or switches on the equipment Italicized text Indicates terms that identify menu items or options in the system display window CE marking information The MAC 400 system bears the CE mark CE 0459 notified body GMED indicating its conformity with the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive The system delivers 3 channel ECG recordings in automatic and arrhythmia modes and 1 or 3 channel ECG recordings in manual mode The country of manufacture can be found on the equipment labeling The safety and effectiveness of this device have been verified against previously distributed devices All standards applicable to presently marketed devices may not be appropriate for prior devices for example electromagnetic compatibility standards This device will not impair the safe and effective use of previously distributed devices NOTE Electromagnetic compatibility information can be found in the MAC 400 Resting ECG Analysis System Service Manual MAC 400 Resting ECG Analysis System Safety and Warnings Guide 2007 2008 General Electric Company All Rights Reserved Product use and classification RECOMMENDATIONS Operating the system near radio frequency RF electromagnetic interference EMI above the conditions defined in the electro
22. harge the battery Consult instructions for use Consult accompanying documents for cautions Classified with respect to electric shock fire mechanical and other specified hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 EN 60601 2 25 EN 60601 1 IEC 60601 1 2 2001 IEC 60601 2 51 Indicates that the device is classified as Ordinary Equipment enclosed equipment without protection against ingress of water Indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Do not throw or dispose of in fire Contains Lithium Ion This symbol indicates General recovery recyclable and must not be disposed of as unsorted municipal waste and must be collected separately Manufacturer name and address Date of Manufacture Year Month Batch code of paper or battery Catalogue number Part number Symbol Description Function Serial number European authorized representative The packaging of this product can be recycled Humidity limitation Atmospheric pressure limitation Environment friendly Use Period per Chinese standard SJ T11363 2006 China specific PCT GOST marking symbolizing conformity with applicable Russian Gosstandart technical and safety standards
23. hown Correct ELECTRODE PLACEMENT This table explains the location of each placement and identifies the labels for AHA or JEC notations AHA Label IEC Label Electrode Placement V1 red Cl red Fourth intercostal space at the right sternal a V2 yellow C2 yellow Fourth intercostal space at the left sternal Midway between C2 V2 and C4 V4 V4 blue C4 brown Mid clavicular line in the fifth intercostal S E ae en a V5 orange C5 black Anterior auxiliary line on the same horizontal eee O alaa ne V6 purple C6 purple Mid auxiliary line on the same horizontal pens EMM tvs caveats LA black L yellow Above left wrist alternate placement left ee ia S Oena LL red F green Above left ankle alternate placement upper pe ES ecto RL green N black Above right ankle alternate placement BEES ROSS topical RA white R red Above right wrist alternate placement right a a NOTE Alternate placements apply when using disposable electrodes F Recording an ECG in all operating modes 1 Turn on the device and wait for the self test to end 2 Apply all electrodes to the patient and connect the patient cable to the device 3 Using the cursor keys select the operating mode Automatic Manual or Arrhythmia 4 Check the device settings e Lead standard CABRERA e Speed 50 25 mm s 5 mm s for manual and arrhythmia modes e Sensitivity gain 20 10 5 mm mV e Muscle filter off 20 35 Hz e AC
24. ified and depending on activity CLEANING AND DISINFECTING PATIENT CABLES AND LEAD WIRES 1 Remove cables and lead wires from the system before cleaning 2 Avoid pulling long wires from connector ends Metal connections can be pulled away from the connectors 3 To clean cables and lead wires wipe using a lightly moistened cloth with mild soap and water Then wipe off excess moisture and allow to air dry CAUTION EQUIPMENT DAMAGE SIGNAL DETERIO RATION Any contact of disinfectant solutions with metal parts may cause corrosion Avoid using disinfectant solution around the metal parts 4 To disinfect cables and lead wires wipe exterior with a soft lint free cloth Use the following solution as recommended in the APIC Guidelines for Selection and Use of Disinfectants 1996 e Sodium hypochlorite 5 2 household bleach minimum 1 500 dilution minimum 100 ppm free chlorine and maximum 1 10 dilution e Any sodium hypochlorite wipe product that meets the above guidelines can be used NOTE Wring excess disinfectant from the cloth before using 5 Wipe off cleaning solutions with a clean lightly moistened cloth CE 0459 MAC 400 Resting ECG Analysis System Maintenance Guide 2007 2008 General Electric Company All rights reserved 6 Dry thoroughly with a dry lint free cloth and let air dry for at least 30 minutes Do not to let liquid pool around the connection pins NOTE Drying times may vary b
25. l 3 Replace the platen when it is completely dry NOTE Do not use products that can harm the heating element such as sandpaper Avoid unnecessary force when handling the printhead REPLACING PAPER The MAC 400 system uses z fold writer paper pads Optional roll paper can be ordered NOTE Use only original GE writer paper This paper has a special coating that prevents contamination and debris collection on the printhead and electrostatic buildup The thermosensitive layer and the printhead characteristics are exactly matched Using other paper may result in recordings of poor quality The printhead may wear out prematurely and use of other paper may void the warranty CAUTION RISK OF SKIN BURNS The printhead gets hot when recording Do not to touch the thermal printhead when inserting the paper INSTALLING ROLL PAPER The MAC 400 system comes with z fold paper but you can use the approved roll paper NOTE You must change the system settings from z fold to roll paper 1 Open the printer door locate the spindle and remove any leftover paper 2 Slide the paper roll onto the spindle 3 Place the roll with the print side red grid facing the thermal printhead into the compartment by fitting the spindle into the grooves on either side 4 Unroll the beginning of the paper and close the door Make sure that the paper is exactly positioned on the pressure roller and that the door locks into place on both sides S
26. llator protection use only the recommended cables and lead wires Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation Polarizing electrodes stainless steel or silver constructed may cause the electrodes to retain a residual charge after defibrillation A residual charge will block acquisition of the ECG signal Whenever patient defibrillation is a possibility use nonpolarizing silver silver chloride construction electrodes for ECG monitoring Defibrillator precautions Electrodes Magnetic and Magnetic and electrical fields can interfere with proper electrical performance of the device Make sure that all external interference devices operated near the device comply with the relevant EMC requirements X ray equipment or MRI devices may interfere with system performance because they may emit higher levels of electromagnetic radiation Explosion Do NOT use in the presence of flammable anesthetics hazard vapors or liquids Interpretation Computerized interpretation is only significant when hazard used in conjunction with clinical findings A qualified physician must over read all computer generated tracings Operator Medical technical equipment such as this electrocardiograph system must only be used by persons who have received adequate training in the use of such equipment and are capable of applying it properly Shock hazard Improper use of this device prese
27. magnetic compatibility EMC Standard EN60601 1 2 for Radiated Immunity field strengths above 3 volts per meter may cause waveform distortions Portable and mobile RF communications equipment can affect medical electrical equipment Users should consider RF sources such as radio or TV stations and hand held or mobile two way radios when installing a medical device or system Adding accessories or components or modifying the medical device or system may degrade the EMI performance Consult with qualified personnel regarding changes to the system configuration Medical electrical equipment requires precautions regarding EMC and needs to be installed and used according to the EMC information provided in the product service manual The use of accessories transducers and cables other than those specified or sold by the manufacturer may result in increased emissions or decreased immunity of the system The system should not be used nearby or stacked with other equipment If stacking or using near other equipment cannot be avoided observe to verify normal operation Review the AAMI Committee Technical Information Report TIR 18 Guidance on Electromagnetic Compatibility of Medical Devices for Clinical Biomedical Engineers for details on evaluating and managing an EMI environment in the hospital Take the following actions to reduce the risk of medical device EMI and achieve EMC e Assess the EMC environment of the facility and identify radio t
28. mng e ENO DE E acai a signal delay of 4 seconds list No default always all device settings sequential reports divided into 4 segments remains as no Operating mode manual automatic or arrhythmia only quarters of 2 5 seconds The F R F fan fold z fold paper Paper speed in millimeters per second mm s first one reflect the a 2 5 R roll paper TE ET a second quarter the secon AR control On O Enables disables the HR Sensitivity gain in millimeters per Millivolt mm mV group reflects the second id 4 indication function in n Power key press to turn on and off quarter and so on A 10 second Automatic and Manual Mode rhythm recording can be If disabled the MAC 400 turns added off when the system is idle for of 5 BPM high Low limit range 30 to 120 Enter key press to confirm selections during device Hnit must beat BPM configuration least 5 BPM above High limit range 80 to 240 low limit BPM KJ Override O Off When enabled the device 5 minutes Cursor control keys press to move the cursor up down starts recording in automatic HR conrol T45 T130 eaa ea right or left to select menu items and change settings mode even if an electrode is low limit and high 30 to 120 and 80 to values Cursor left reduces the disconnected limit in increments 240 value cursor right increases it Start Stop key press to start or stop a recording Lead selection key press to change the ECG leads The key is only enabl
29. nts a shock hazard Failure to observe the following warnings may endanger the lives of the patient the user and bystanders Disconnect from the power source before disconnecting the cable from the device to reduce the risk of inadvertently introducing metal parts in the sockets of the power cord and coming in contact with line voltage Site Do not route cables in a way that they may present a requirements stumbling hazard For safety reasons connectors for patient cables and lead wires are designed to prevent disconnection if pulled on For devices installed above the patient adequate precautions must be taken to prevent them from dropping on the patient CE MAC 400 resting ECG analysis system guides 1 of 7 2032589 001 Revision E 0459 Accessories To ensure patient safety use only parts and accessories supplies manufactured or recommended by GE Parts and accessories must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards Improper connection will cause inaccuracies in the ECG Trace each individual lead wire from its acquisition module label to the colored connector and then to the proper electrode to ensure that it is matched to the correct label location Proper lead wire connection Before installation Compatibility is critical to safe and effective use of this device Please contact your local sales or service representative prior to installation
30. ransmitters and or areas where critical medical devices are used such as the emergency room and intensive care units e Increase the distance between sources of EMI and susceptible devices e Remove the devices that are highly susceptible to EMI e Lower the power transmitted from electrical and electronic equipment EMI sources under hospital control i e paging systems e Label devices susceptible to EMI e Educate facility staff nurses and doctors to identify and recognize potential EMI related problems CLASSIFICATION The device is classified according to IEC 60601 1 as Type of protection against Class I or internally powered equipment ae OS or o n Degree of protection against Type CF defibrillation proof applied part armena o a OO E a Degree of protection against Ordinary equipment enclosed equipment harmful ingress of water without protection against ingress of water IPX0 Degree of safety of Equipment not suitable for use in the presence application in the presence of a flammable anesthetic mixture with air or of a flammable anesthetic with oxygen or nitrous oxide mixture with air oxygen or nitrous oxide Methods of sterilization or Not applicable disinfection recommended by the manufacturer Mode of operation Continuous operation RESPONSIBILITY OF THE MANUFACTURER GE 1s responsible for the effects of safety reliability and performance only if e Assembly operations extensions rea
31. s into place on both sides ce 0459 MAC 400 Resting ECG Analysis System Installation and Setup Guide 2007 2008 General Electric Company All rights reserved A red line at the top of the last ten sheets indicates that the paper supply is low Change paper as needed NOTE For instructions on loading roll paper see the MAC 400 Resting ECG Analysis System Maintenance Guide Initial system setup THE SETUP MENU Press om off to turn on the device and then press WT configuration to access the setup menu Use the setup menu to navigate between system settings and select the options you want For more information see System Symbols and System Menu Descriptions on page 4 THE SYSTEM PARAMETERS TOOLS Use these tools and guidelines to help you define the operating parameters 1 Use up down cursor to select a menu item 2 Use _ right left cursor to select the desired setting 3 Always press enter to confirm your selection 4 Always press jf configuration to save and exit the setup menu SETTING OPTIONS FOR INITIAL USE A Selecting a language Different languages are available for the display text and printed ECG reports 1 Press T configuration to display the language selection menu 2 Use the right left cursor to select the language 3 Press enter to confirm your selection B Selecting the lead notations There are two different lead notation options AHA and JEC
32. supervision of a licensed healthcare practitioner Serviceable parts MAC 400 Resting ECG Analysis System Safety and Warnings Guide 2007 2008 General Electric Company All Rights Reserved General information RECORDING ECGS DURING DEFIBRILLATION This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery as required by test standards The patient signal input of the acquisition module is defibrillation proof It is not necessary to remove the ECG electrodes prior to defibrillation When using stainless steel or silver electrodes a defibrillator discharge current may cause the electrodes to retain a residual charge causing a polarization or DC offset voltage Electrode polarization blocks acquisition of the ECG signal If a defibrillation procedure is necessary use non polarizing electrodes such as silver silver chloride types to avoid a DC offset voltage when subjected to a DC current If using polarizing electrodes disconnect the lead wires from the patient before delivering the shock Electrode defibrillation recovery allows the ECG trace to return after defibrillation We recommend using nonpolarizing disposable electrodes with defibrillation recovery ratings as specified in AAMI EC12 3 2 2 4 MMS P N 9623 103P Silver Mactrodes MMS spec TP9623 003 AAMI EC12 requires that the polarization potential of an electrode pair does not exceed 100 mV five seconds after a defibrillation
33. tery Check that Battery not contacts are clean Notify functioning properly service to check and replace the battery Clear message with ATTENTION The printer Turn off device and power on Over mechanism has after 3 to 4 minutes If problem heated up due to recurs with normal use notify heavy use service temperature Contact service and have device repaired before using it again Test failed Power on self test CODE 1 failed VECTOR Test failed Power on self test Contact service and have device CODE 2 RAM failed repaired before using it again Contact service and have device repaired before using it again Contact service and have device repaired before using it again Test failed Power on self test Test failed Power on self test CODE 5 DSP failed 6 of 7 Revision E Troubleshooting tips These errors may occur while operating this system If you perform the recommended actions and the condition remains contact GE Service for assistance Periodic superimposition of AC line interface 50 60 Hz See Figure 2 Superimposition of irregular interference signals See Figure 1 The printed date and time are incorrect The green LED does not light up although the recorder is connected to the power line Recorder does not write over the entire paper No paper transport after activation of an operating mode or the recorder does not stop and continues to feed paper
34. three recorded leads represent the first segment 0 2 5 seconds the second group of leads represents the second segment and so on You may also choose to record a 10 second rhythm strip You may choose standard or CABRERA lead sequence recordings The factory default records all 12 leads simultaneously on four sheets each representing a period of 3 seconds To print a duplicate report press the copy key Before printing the copy you may change the speed gain leads and report format NOTE If lead failure occurs the system will operate in automatic mode only if the override function is enabled in the setup menu MANUAL MODE In manual mode the system simultaneously records or 3 default leads of ECG in real time MAC 400 resting ECG analysis system guides 2032589 001 ARRHYTHMIA MODE In arrhythmia mode the system continuously scans the ECG and initiates a recording Specific conditions trigger the recording which continues as long as the condition s exist These recordings include a 5 second period before the event The first 30 seconds are recorded at the selected paper speed then at 5 mm s When the start stop key is pressed the system prints two pages and then checks for conditions Conditions that initiate a recording are e A heart rate exceeding one of the set limit values e QRS complexes with an RR interval shorter than 0 8 times or greater than 1 5 times the RR interval averaged over the 4 preceding R
35. tient and set up the electrode and lead wire connections A Prepping the patient s skin Prep the skin to help ensure an interference free ECG To prep the skin 1 Shave hair from the area and degrease each electrode site with alcohol 2 Use an abrasive pad or skin prep cream to remove the epidermal skin layer at each site B Applying electrodes Apply electrode cream or gel to the electrode sites and attach the suction bulbs or optional disposable electrodes at each site In situations where hair is present electrode cream or gel helps to seal the electrodes If using electrode paper moisten it with water and apply it to the patient s skin at the application points Apply a small amount of electrode cream or gel to the metal electrode of each clamp Apply the clamp electrodes to the limbs as indicated in the Electrode Placement table C Recording standard leads Four limb and six chest electrodes must be applied to the patient for acquisition of the standard leads I IH II aVR aVL aVF and V1 C1 to V6 C6 Connect the six bulb electrodes to the chest lead wires and the four clamp electrodes to the limb lead wires D Connecting the lead wires as indicated ng en C 2 Cd Rightleg lt Right m To chest leads Wy E ef m Let Leg CE 0459 MAC 400 Resting ECG Analysis System Operator Guide 2007 2008 General Electric Company All rights reserved E Arranging the patient cable as s
36. ymbol Displays when the ECG data acquisition or recording is active Operating mode Automatic Additional default settings not indicated on the display e Notation AHA e ADS Enabled e Report format Simultaneous short e Override Disabled NOTE For further descriptions of the settings see System Menu Descriptions on page 4 3 of 7 Revision E MAC 400 Resting ECG Analysis System Installation and Setup Guide 2007 2008 General Electric Company All rights reserved The system setup function allows you to customize many of the MAC 400 Notation AHA IEC Electrode designations No of leads 5 1 Number of leads recorded in Cut off frequency 0 01 0 04 Selection of the lower cut off system settings Once you customize and save your settings they will AHA RA LA RL LL V1 to manual mode manual mode 1 or 3 0 08 0 16 frequency of the signal activate each time you turn on the system V6 Speed in mm s 25 50 Paper speed 25 or 50 mm s transmission range 0 01 0 04 System symbols eee ORS Sensitivity Gain 5 J10 20 5 10 or 20 mm mV O USor dlo Be Lead Stand Standard Standard lead sequence l Contrast increase decrease Cursor right increases contrast Cabr CABRERA L II HI aVR aVL aVF V1 to ed Mi h ee une Pi oe ee Cursor left decreases contrast line frequency Off 50 for countries with 50 Hz ECG lead indicator V6 power line ORS beep Off On If turned on the system
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