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- GTS Medical, Inc.

1. Checks before each use Before each use visually inspect the device the leads and electrodes for signs of mechanical damage If you detect damages or impaired functions that may adversely affect the safety of the patient or user do not use the device before it has been repaired 52 MAC 1200 Technical Inspections For safety the devices require regular maintenance To ensure functional and operational safety of the MAC 1200 units Technical Inspections should be carried out on an annual basis These checks should be performed by persons with adequate training and experience The checks can be carried out by Marquette within the framework of a service contract The inspections include the following checks e Visually inspect the device and the accessories for signs of mechanical damage that may impair the device functions e Check that the device labelling relevant for safety is legible e Runa performance test as described in the operator s manual e Measure the resistance of the protective earth conductor and the equivalent leakage current per your national regulations The device does not require any other maintenance 227 492 04 C Troubleshooting 12 Troubleshooting Cause Remedy Figure 12 1 Regular AC line interference Symptom Cause Figure 12 2 Irregular AC interference Remedy Symptom Cause Remedy Symptom Cause Remedy Symptom Cause Remedy
2. the event is recorded with context Figure 7 1 The length of the recording varies with the duration of the event episode In the setup menu section 9 4 Arrhythmia Mode you determine the conditions for a recording the recorder starts each time it detects a single beat event all the recorder starts each time it detects an event different from the previous event unequal the recorder does not start at all no Some of the system settings can be customized They are labeled with configurable The following information refers to a unit with the system defaults see table at left For instructions on changing the system setup refer to section 9 4 Arrhythmia Mode MAC 1200 37 Arrhythmia Mode right leg electrode disconnected right arm electrode disconnected left arm electrode disconnected left leg electrode disconnected chest electrode V1 disconnected chest electrode V2 disconnected chest electrode V3 disconnected chest electrode V4 disconnected chest electrode V5 disconnected chest electrode V6 disconnected Messages indicating disconnected electrodes Tip With er a single page recording can be initiated after program start Tip Please note that filters may suppress diagnostically relevant portions of the signal Filters should therefore only be enabled if necessary 38 MAC 1200 7 2 Recording After switching on the unit press GED to select the Arrhythmi
3. via the RS232 interface will be cleared from the recorder memory yes no Configuration of the 12SL Interpretation Use screening criteria The screening criteria can be enabled or disabled Default disabled Suppress normal statement If you select Yes the interpretation statement normal ECG will not be shown Suppress abnormal statement If you select Yes the interpretation statement abnormal ECG will not be shown No interpretation If you select Yes no results of the 12 SL interpretation will be shown Override function When this function is enabled yes the recorder will print in 12 Lead Mode even when not all electrodes are applied or do not supply a good signal When electrodes are disconnected a message informing the user of poor signal quality will be printed on the recording Furthermore systems with interpretation capability will print a message indicating that the measurement results and interpretation may be incorrect MAC 1200 43 System Setup 9 3 6 Lead Mode e Use the cursor keys to position the bar cursor on 6 Lead and confirm the selection with The setup menu for continuous recording of 6 leads will appear Report sequence 1 STANDARD 1 II III aVR aVL aVF VI V2 V3 V4 V5 V6 2 CABRERA aVL l aVR II aVF III VI V2 V3 V4 V5 V6 3 SEQ NO 4 here users can define a custom report sequence e Position the cursor on SEQ NO
4. 227 492 04 C 4 2 2 Applying Electrodes Thorax Shave application points if necessary 4 2 3 Electrode Placement for Standard Leads I Il Ill aVR aVL aVF VI V6 For acquisition of the standard ECG leads four electrodes must be applied on the limbs and six on the chest The limb electrodes should be placed above the wrists and ankles Figure 4 3 shows the chest electrode application points V1 V2 V3 V4 V5 V6 MAC 1200 4th intercostal space at the right border of the sternum 4th intercostal space at the left border of the sternum midway between locations V2 and V4 at the mid clavicular line in the 5th intercostal space at the anterior axillary line on the same horizontal level as V4 and V6 at the mid axillary line on the same horizontal level as V4 Connect the 10 lead patient cable as shown in Figure 4 4 Arrange the leadwires and patient cable as shown in Figure 4 5 21 Preparations for ECG Recording 4 3 Artifact Due to Poor Electrode Application The electrocardiograph is equipped with state of the art electronic utilities that ensure artifact free recordings Among these are the automatic baseline adjustment and the anti drift system cubic splinie ADS At the beginning of the recording the automatic baseline adjustment algorithm verifies the incoming signal and adjusts the baseline position accordingly During the recording the anti drift system cubic
5. 227 492 04 C MAC 1200 Symptom Regular AC line interference 60 Hz interference from the power line Ground stretcher verify position of the leadwires Switch on the AC line filter if necessary Irregular interference signals Muscle artifact caused by patient movements hiccup coughing The patient should be warm enough and resting comfortably place cushions under arms and knees Comfort patient or distract patient s attention Enable muscle filter 20 Hz 40 Hz if necessary The printed date and time are incorrect Built in lithium battery is depleted The battery has a life of approx 5 years Have battery checked and replaced by the Marquette service The green standby indicator 23 does not light up although the unit is connected to the power line Defective AC power cord or fuse Notify service The recorder does not write over the entire paper width Paper compartment not properly closed Paper door must lock into place on both sides 53 Symptom Cause Remedy Symptom Cause Remedy Symptom Cause Remedy 54 Troubleshooting In 12 Lead Mode the recorder does not stop and continues to feed paper This does not happen in 6 Lead Mode The paper pad was inserted the wrong way round so the recorder cannot detect the queue mark Insert the paper pad as instructed Recorder does not start after activation of the VO key or the recording is abor
6. 4 e Press The display shown in Figure 9 2 will appear SEQ NO 4 Lead Label I Report sequence Figure 9 2 Creating a custom report sequence Press 4 The cursor will move to the position for entry of the lead in channel 1 Follow these steps if you wish to record aVR in channel 1 for instance e Enter AVR and confirm the entry with The cursor moves to the position for entry of the lead designation AVR appears there as well e If you wish to enter another designation you can overwrite the default name 4 characters max e Confirm your entry with J and repeat the above steps for channel 2 etc You can write over SEQ NO 4 if you wish to enter another name for the report sequence 44 MAC 1200 Gain auto 5 10 20 40 mm mV with auto the unit will automatically determine the appropriate gain setting for the 6 simultaneous leads Speed Changes the writer speed Default 25 mm s Muscle filter AC line filter Elimination of muscle artifact and AC line interference Default muscle filter No AC line filter Yes Filter frequency Cut off frequency of the muscle filter 140 Hz 20 Hz The frequency range is indicated in the lower margin of the recording strip 0 08 40 Hz 40 Hz muscle filter enabled 0 08 20 Hz 20 Hz muscle filter enabled 0 08 150 Hz muscle filter off Anti drift system ADS cubic spline In case of wandering baselines
7. MAC PC resting ECG analysis systems acquisition modules and Holter recorders are repaired on a 48 hour turnaround basis Send items for 48 hour repair to Marquette Service and Supplies Attn 48 Hour Turnaround Repair 100 Marquette Drive Jupiter FL 33468 9100 Telephone 1 800 552 3246 Holter recorders or 1 800 558 7072 MAC PC systems and acquisition modules Diagnostic hardware Send all items except 48 hour turnaround repair items to the above address Attention Diagnostic Hardware Repair Telephone 1 800 558 5102 Service Agreements For information about service agreements call 1 800 552 3248 Other questions or problems For additional information contact one of the offices Australia Marquette Medical Systems Australia Pty Ltd Forest Corporate Centre Suite 7 19 Rodborough Road Frenchs Forest NSW 2086 Australia Telephone 61 2 9975 5501 Fax 61 2 9975 5503 Japan Marquette Medical System Japan Waseda Hirai Building 7th Floor 1 18 9 Nishi Waseda Shinjuku KuTokyo Japan Telephone 81 3 3203 1631 Fax 81 3 3202 1626 Hong Kong Marquette Medical Systems HK 26 F Catic Plaza 8 Causeway Road Causeway Bay Hong Kong Telephone 852 2804 2320 Fax 852 2804 1776 Southeast Asia Marquette Electronics SEA Pte listed below 2 Leng Kee Road 04 04A Thye Hong Centre Headquarters Singapore 0315 Telephone 65 471 2133 GE Marquette Medical Systems Inc Fax 6
8. V5 V6 audio signal at printer start Data interface one serial RS232 interface for exchange of data with suitable external devices and software handshake RS232 interface standard V 24 interface e input voltage range 15V max output voltage range 5 V min e interface protected from electrostatic discharge for 10 kV max 227 492 04 C Technical Specifications Pin assignment of data port 2 RXDE 3 TXDE 5 circuit reference Signal Transmission Patient input to recording After lead formation and digitization simultaneous transmission of all electrode signals to the digital processing system muscle filter AC filter pacing pulse identification automatic or manual sensitivity adjustment automatic baseline adjustment and drift compensation by means of the anti drift system A D S can be enabled or disabled simultaneously for all channels digital output of processed signals via thermal array printhead e low cut off frequency 3 db limits 0 08 Hz equivalent to a time constant of 2 04 s e high cut off frequency 3 dB limits operating mode 12 Lead 6 Lead 150 Hz IEC AHA operating mode Arrhy 100 Hz IEC e signal sampling rate 1000 s e resolution referred to the input 5 yV e output rate to recorder 2000 s e for all leads gain adjustment in four steps 40 20 10 5 mm mV e with active muscle filter low pass characteristic 3 dB drop of the amplitude frequency response at ap
9. service technician before it is used again BEFORE USE Before putting the system into operation visually inspect all connecting cables for signs of damage Damaged cables and connectors must be replaced immediately BEFORE USE Before using the device the operator must verify that it is in correct working order and operating condition For instructions refer to section 3 2 2 Performance Check in this chapter CONDUCTIVE CONNECTIONS Do not allow electrodes to come into contact with conductive parts The neutral electrode in particular must not be connected to earth DISCONNECTION FROM MAINS When disconnecting the system from the power line remove the plug from the wall outlet first Then you may disconnect the power cord from the device MOISTURE CONDENSATION Devices intended for emergency application must not be stored or transported at temperatures which cause moisture condensation at the application site Wait until all moisture condensation has evaporated before using the device MPSO The use of a multiple portable socket outlet MPSO for a system will result in an enclosure leakage current equal to the sum of all individual earth leakage currents of the system if there is an interruption of the MPSO protective earth conductor Do not use an additional extension cable with the MPSO as it will increase the chance of the single protective earth conductor interruption 227 492 04 C OPERATOR T
10. the anti drift system restores the baseline to its original position signal delay with ADS approx 2 s Default No Start at queue mark Before each recording the recorder advances the paper to the beginning of a new page yes no 227 492 04 C System Setup 9 4 Arrhythmia Mode e Use the cursor keys to position the bar cursor on Arrhythmia and confirm the selection with Gb The arrhythmia mode menu will appear Report sequence STD_CH VI V2 V3 V4 V5 V6 STD_RED I II M V2 V4 V6 STD_LI I IL M aVR aVL aVF CABR_LI aVL I aVR II aVF III SEQNO 6 VI V2 V3 V4 V5 V6 CH chest leads RED reduced number of leads LI limb leads Gain auto 5 10 20 40 mm mV with auto the unit will automatically determine the gain setting Muscle filter AC line filter Elimination of muscle artifact and AC line interference Default muscle filter No AC line filter Yes Filter frequency Cut off frequency of the muscle filter 40 Hz 20 Hz The frequency range is indicated in the lower margin of the recording strip 0 08 40 Hz 40 Hz muscle filter enabled 0 08 20 Hz 20 Hz muscle filter enabled 0 08 100 Hz muscle filter off Trend rec The slow trend recording of 5 mm s automatically begins at program start no yes 227 492 04 C Arrhythmia data The recorder will document arrhythmias in the following situations each t
11. 6 Sample recording 22 MAC 1200 227 492 04 C Preparations for ECG Recording 4 4 Entering Patient Data It is possible to enter patient data and have them For entry of numbers e g date of birth it is not annotated on the recording for easy archiving of necessary to press the Shift key patient records All entries must be confirmed with amp e Press We to enter the patient data mode Press OG or VO to exit the patient data The recorder displays the menu items in a mode defined order The table below shows the menu items in the correct To skip a menu item press ep or the cursor key order On the display selected options are shown in or ap brackets Refer to section 9 7 for details on Itis not possible to write capital and small letters configuring the patient data prompts do not use the Shift key em em ew Cs me em m j pa perm poo ea ooo mw j pa ss S ee p p e m f pe v f p e p w ooo Ordering Physician enabled selection from a list of 10 names Referring Physician disabled selection from a list of 10 names Technician enabled selection from a list of 10 names 227 492 04 C MAC 1200 23 Preparations for ECG Recording New patient yes existing patient data are deleted no entered data can be edited Date of birth the slash key must be entered between month day year Patient ID 20 characters maximum Pacemaker influences the identificat
12. BD The option code menu will appear MEAS measurement of the 10 second resting ECG DIAG measurement and interpretation of the 10 second resting ECG MEMO program for storage of up to 40 resting ECGs C100 activates the three options MEAS DIAG MEMO for a maximum of 100 ECGs C500 activates the three options MEAS DIAG MEMO for a maximum of 500 ECGs EVAL activates the three options MEAS DIAG MEMO for a maximum of 4 weeks e Enter the code number and exit the menu with VO 227 492 04 C Loading Chart Paper 10 Loading Chart Paper e Switch on the recorder e Pull up the handle of the paper door and fold it out Figure 10 1 e Remove the cardboard backing of the previous paper pad e Remove the cardboard from the top of the new pad and place the pad including the cardboard backing at the bottom and with the arrow pointing towards the unit into the paper compartment Figure 10 2 Pull the top sheet out of the compartment and guide it around the guide roller Figure 10 3 Figure 10 3 Guiding the leading paper edge over the guide roller 227 492 04 C MAC 1200 49 Loading Chart Paper Figure 10 4 Closing the paper compartment door 50 Tip If you store the recordings in plastic folders these should be made of polyethylene because the traces fade in PVC covers if in doubt insert a sheet of paper between recording and folder When closing the paper door take care that it locks
13. O 28 MAC 1200 227 492 04 C Recording in 12 Lead Mode 5 4 The Report Formats The length and scope of the reports depends on the implemented software standard MEAS measurement DIAG interpretation The table below shows all of the 12 different report formats available with the MAC 1200 units Format ECG traces ECG traces Pages ht lend lead 4x25R3 43 1 3 25mmfs yes yes EE ET ges 3 me Somms yes yes 26 1x10R12 162 1 no 25mms mo mn mme e o ml measurement results and interpretative statements are only available from MAC 1200 with the appropriate software options Caution The printed reports are unconfirmed documents They must be overread verified and signed by a physician for confirmation GE marquette MAC 1200 John Doe University Hospital Dr Williams male Caucasian 32 years 6 7 ft 172 Ib 161 133 mmHg Pacemaker 414 355 378 HR 101 BPM ele el He le dd pe fb rdp dr prefer EE EE EE pe i pen FE SE eds Vee a ere ies EE saad cil OR ee RE Bali GE A DAN GE OR SA DANS PT PP GS ER SG GE SD eee MAE S R TE DA hee MENE DE MER SE Ke PR TR ST L KOR ND BIR RARE CAA NE TER MRS DAA RER ae ad Feb 09 1998 11 07 22 AM 25mm s 10mm mV ADS 50Hz 0 08 150Hz 1x10Rt2 12Lead 12SL V5 0 Figure 5 5 1x10R12 report format 227 492 04 C Detailed results In the setup menu of units equipped with the MEAS or DIAG option you can choose the Deta
14. Patients ECG Recording during Defibrillation Recording ECGs of Pacemaker Patients Due to the slow paper speed it is not possible to display pacer pulses directly on the ECG recording At a paper speed of 50 mm s and a pulse duration of 0 5 ms the width of the recorded pacer pulse would be only 0 025 mm For this reason the recorder reduces the pulse amplitude and expands the pulse width so that the pacer pulse is easier to identify The MAC 1200 records the pulse with the correct polarity with a width of 5 ms and with the same amplitude in all leads depending on the polarity of the pacer pulse in leads I and II the pacer pulse in lead III may be suppressed The amplitude of the reverse current may differ from lead to lead Figure 8 1 shows an ECG recording with pacer pulses Figure 8 1 ECG recording with pacer pulses Warning If several adverse conditions exist at once the possibility that the pacer pulses are interpreted and counted as QRS complexes should be considered At the same time however QRS complexes might be suppressed in certain situations Therefore pacemaker patients should always be watched closely 227 492 04 C ECG Recording During Defibrillation The patient signal input is defibrillation proof so it is not necessary to remove the ECG electrodes before defibrillating the patient However when using stainless steel or silver electrodes the defibrillator discharge current may
15. Transmission Error CSD The connection was interrupted due to a fault Check interface Fault in RS232 interface or modem Modem may be switched off Modem configuration error 227 492 04 C MAC 1200 31 Recording in 12 Lead Mode 5 5 1 Sending Data to a MUSE CV System Before sending data to the MUSE CV system the MAC 1200 automatically logs on to MUSE Then the data will be transferred If the transfer is stopped the MAC 1200 may take a few seconds before cancelling the connection because it has to log off the MUSE system first Then the communication link with the receiving modem is interrupted and the standard display reappears 5 5 2 Receiving Data with the CSI Communication Protocol 1 Press 8 to enable the receive data mode This will initialize the modem 2 Press to ready the MAC 1200 for receiving data the standard screen reappears and you can continue to operate the unit in 12 Lead Mode or press Q to disable the receive data mode While in the receive data mode the unit receives ECG data from the host system either directly or via modem RS232 interface When an ECG has been received the unit automatically quits the receive data mode After each transfer this mode must be reenabled with 2 The following information is found in the bottom line of each report the sender the software version and analysis program version used at the sending unit e g ACQ D
16. exceeds a limit value yes no only in 6 Lead and Arrhythmia Modes The limit value 220 age can be changed manually Lead labels AAMI codes RA LA RL LL V1 to V6 or IEC codes R L F N C1 to C6 Date Format month day year or day month year Time Time format 12 hours am pm or 24 hours 46 MAC 1200 Units Units of measurement for the patient s height and weight in Ilb or cm kg Mains AC line frequency USA 60 Hz Europe 50 Hz LCD light off after If operating controls are not activated within the selected period of time the display backlighting automatically switches off system default 5 min adjustment range to 99 min Default mode This is the operating mode the unit defaults to after power up 12 Lead 6 Lead Arrhythmia Test DATA Used for demonstration purposes yes It must be set to no for proper clinical use System setup Selecting Yes will restore the default setup including the defaults of the three operating modes The electrocardiograph must be switched off standby and on again for the new settings to become effective Print Setup Lists Selecting yes will display a menu with all available setup lists all lists General Settings Communication External Devices Patient Data Setup 12 Lead 6 Lead Arrhythmia Language Select the language for user interface and printouts 227 492 04 C System Setup 9 6 Co
17. into place on both sides There is a window in the paper door that allows you to look inside the compartment and check the paper supply Use only the original Marquette CONTRAST chart paper or the Marquette thermal paper with queue marks or holes This paper has a special coating that prevents contamination and debris collecting on the printhead and electrostatic build up Furthermore the thermosensitive layer and the printhead characteristics are exactly matched Using other paper may result in recordings of poor quality Moreover the printhead may wear out prematurely Use of other paper voids the warranty e Holding the leading edge of the paper in place between the two markers on the recorder close the paper door Figure 10 4 Ensure that it locks into place on both sides When inserting an already started Z fold pad the grid side must face up and the first fold must point towards the paper compartment End of Paper Indication A stripe marks the last 10 pages of the Z fold pad MAC 1200 227 492 04 C Cleaning Disinfection and Maintenance 11 Cleaning Disinfection and Maintenance 11 1 Cleaning and Disinfecting the 11 3 Cleaning and Disinfecting the Recorder Housing Electrodes a In addition to the information given in this manual Warning f F F observe the instructions for use of the respective efore cleaning or disinfecting the device fi 5 fecime electrode types disconnect
18. printhead use only the original Marquette CONTRAST paper or the Marquette thermal paper with queue holes or marks 227 492 04 C MAC 1200 Paper transport paper speed 5 25 50 mm s key selectable error limits at 25 and 50 mm s typ 1 at 5 mm s 10 max At paper end the recorder emits an audio signal and stops recording the last pages of the pad bear a colored stripe in the lower margin Membrane keypad Pushbuttons with tactile feedback function keys for all routine operations alphanumeric keyboard for entry of text Display graphics display with 24 x 40 characaters contrast adjustment resolution of 320 x 240 pixels with display backlighting Indicators LEDs For mains power battery status and start stop function 55 Technical Specifications Automatic functions They assist and facilitate operation by e automatic control of lead selection paper feed calibration configurable e report formatting configurable e automatic baseline adjustment e anti drift system cubic spline compensating for polarization voltage fluctuations configurable Detection of pacer pulses e pulse length between 0 1 and 2 5 ms e pacer pulse marker independent of pulse polarity e pulse amplitude between 5 mV and 700 mV Heart rate indication derivation of the heart rate from all ECG signals e display range between 30 and 300 bpm e display update with every heart beat maximum every 2 seconds
19. 0 558 5102 U S only 561 575 5070 outside U S Fax 561 575 5050 Have the following information handy E part number of the defective part or M model and serial number of the equipment E part number name of the assembly where the item is used E item name and m where applicable reference designation eg R13 12 When ordering additional operator manuals remember to get the software version from either the back of the title page or a printed report 4 MAC 1200 Tech support Tech Support has the most current information about your equipment and can provide assistance with any technical questions or problems E Resting ECG analysis systems 1 800 558 7072 E Exercise testing systems 1 800 558 7072 Ambulatory ECG analysis and editing systems 1 800 558 6802 m MARS unity workstation 1 800 282 6297 m MUSE cardiology management systems D Series errors hardware problems 1 800 558 7070 Network systems errors hardware problems 1 800 645 9309 Applications How to questions E All diagnostic cardiology products except MARS CRS full disclosure software 1 800 531 5613 E MUSE CardioWindow cath lab information systems 1 800 343 9341 m MARS clinical review station full disclosure software USA 1 800 992 0344 Canada 1 800 874 4357 United Kingdom 0800 89 1645 Other countries 414 255 9831 227 492 04 C How To Reach Us Repairs 48 hour turnaround Some Marquette products
20. 00 227 492 04 C Index 12 Lead mode brief operating instructions 12 Lead mode system defaults 12 Lead mode system setup EE ot 6 Lead mode brief operating instructions 6 Lead mode system defaults 6 Lead mode system setup AC line frequency AC line interference Activating options Anti drift system Arrhythmia codes Arrhythmia mode Arrhythmia mode brief operating instructions Arrhythmia mode system defaults Arrhythmia mode system setup Arrhythmia recording Automatic baseline adjustment B Battery charging Baud rate Brief operating instructions 12 Lead mode Brief operating instructions 6 Lead mode Brief operating instructions arrhythmia mode C Cart to cart communication Caution definition Cleaning Communication system setup Connecting external equipment Contrast adjustment Controls overview Cubic spline D Danger definition Date Defibrillation while recording ECG Detailed results Disinfection Display backlighting 227 492 04 C Index 33 25 42 36 34 44 46 43 53 48 22 44 40 37 40 37 45 45 22 16 47 33 36 40 32 12 51 47 19 19 10 22 12 46 20 29 42 51 46 MAC 1200 E ECG recording during defibrillation ECG transmission modem ECG transmission to MUSE CV system Electrode placement End of paper while printing Entering patient data Environment operation Environment storage and transp
21. 1 1993 A2 1995 Medical electrical equipment General requirements for safety EN 60601 1 1 9 1994 A1 12 95 General requirements for safety Requirements for the safety of medical electrical sys tems Requirements for the safety of medical electrical systems EN 60601 2 25 1993 Medical electrical equipment Part 2 Special requirements for the safety of electrocardiographs IEC Publication 513 1994 Fundamental aspects of safety standards for medical equipment MAC 1200 15 standby battery low Figure 3 1 Indicators Putting the Device into Operation and Performance Test format store J ie D 3 2 Power Supply The units are powered from the power line or from the rechargeable battery The battery charges automatically when the unit is connected to the power line and the standby indicator 23 is illuminated Figure 3 1 It is not necessary to switch on the device for charging To ensure that the battery is always fully charged leave the electrocardiograph connected to the power line whenever possible After 4 hours the battery has regained its full capacity The battery low indicator 22 is illuminated when battery needs to be charged With a full battery about 50 ECGs can be recorded in 12 Lead Mode When its capacity drops to about 25 recordings the battery is used up and must be replaced by a service specialist Caution To prolong the battery life discharge the battery at least once pe
22. 3 ECG identified by recording date and time Memory is full Delete Walker John Yes No Figure 5 4 Memory full message Tip When you exit the memory function with VO it is not possible to save the current ECG again 5 3 The Memory Function Units equipped with the optional MEMO function permit storage of the ECG including patient measurement and interpretation data with cee The display will indicate the number of stored ECGs 40 max To retrieve an ECG from memory hold down 8 and press cere All stored ECGs can be printed transferred or deleted position cursor on appropriate command J Use 4 if you wish to select the ECGs individually for printing transfer i and confirm with J modification and deletion Individual ECGs may be accessed by patient name Figure 5 2 If a name was not entered the ECG is identified by the recording date and time Figure 5 3 If you try to save an ECG when the memory is full you are informed of the memory status and can remove one of the stored ECGs from memory Use the cursor keys to select the ECG to be deleted After discarding the ECG the unit will automatically save the new data Figure 5 4 The unit may be set up to automatically save ECGs without pressing eee and to remove ECGs from memory that were successfully transferred to a host system MUSE see section 9 2 12 Lead Mode The memory program can be terminated at any time with
23. 5 471 1540 8200 West Tower Avenue Milwaukee Wisconsin 53223 USA Telephone 414 355 5000 800 558 5120 U S only Fax 414 355 5790 Europe Marquette Hellige GmbH Postfach 60 02 65 D 79032 Freiburg Germany Telephone 49 761 45 43 0 Fax 49 761 45 43 233 227 492 04 C MAC 1200 General Information General Information e Standards compliance European Council Directive 93 42 EEC IEC60601 1 2 EN 60601 1 2 Electromagnetic Compatibility Medical Electrical Equipment CISPR11 EN 55011 Radio interference emission IEC 60601 protection class I MDD class IIb UL 2601 1 e The symbol A means Consult accompanying documents It indicates points which are of particular importance in the operation of the device e The warranty does not cover damage resulting from the use of accessories and consumables from other manufacturers e On request Marquette will provide a service manual e The Marquette quality management system complies with the standards EN ISO 9001 and EN 46001 6 MAC 1200 227 492 04 C 1 INTENDED USE AND FUNCTIONAL DESCRIPTION 2 CONTROLS AND INDICATORS 3 PUTTING THE DEVICE INTO OPERATION AND PERFORMANCE TEST 3 1 SAFETY INFORMATION 3 2 POWER SUPPLY Contents 3 3 INSTALLATION AND MAINS CONNECTION 3 4 PERFORMANCE CHECK 3 5 GENERAL DEVICE SETTINGS 3 6 CONNECTING EXTERNAL DEVICES 3 7 CONTRAST ADJUSTMENT 4 PREPARATIONS FOR ECG RECORDING 4 1 CONNECTING THE PATIENT CABLE 4 2 APPLYING
24. CGs Service parts how to order Service requests where to call Setup Software version Specifications Standard leads Supplies how to order Symbols explanation System defaults 12 Lead mode System defaults 6 Lead mode System defaults arrhythmia mode System setup 12 Lead mode System setup 6 Lead mode System setup Arrhythmia mode System setup communication System setup general settings T Technical specifications Technical support Test DATA Thermal paper storage Thorax electrodes application Time Trend recording Troubleshooting Units Warning definition 227 492 04 C 12 28 42 55 21 11 25 34 37 42 44 45 47 46 35 46 50 21 46 45 53 46 12
25. EV CSMRT V5 0M12i HEART V4 3 5 5 3 Cart to Cart Communication Via modem ECG data can be transmitted between two MAC 1200 units or between a MAC 1200 and any ECG recorder using the CSI protocol see sections 5 5 1 and 5 5 2 32 MAC 1200 5 5 4 Modem Setup for Modem gt other If you prefer to use another modem than the standard models listed in the setup menu MultiTech Elsa you will have to enter a few parameters required for communication between the MAC 1200 and the modem For the AT commands which your modem understands please refer to the modem user instructions Three command sequences have to be entered in all each of which defines a specific modem operating state 1 the modem is initialized init string 2 acommunication link is established dial string 3 the communication is terminated hangup string These three strings are entered in the modem setup menu see section 3 6 Connecting External Devices The example below shows the command strings for the MultiTech ZDX modem 1 AT Command for Modem Initialization AT prefix that precedes every command line amp F fetch factory configuration loads the factory configuration from ROM into the active configuration memory RAM MO speaker is always off amp DO ignore DTR status transition amp QI standard AT result code VO digit result codes selected 0 to 999 init string AT amp FMO amp DO amp QIVO 227 492 04 C Recording in 12 L
26. ILVERTRACE SOLAR SOLARVIEW Spectra 400 Spectra Overview Spectra Tel ST GUARD TRAM TRAM NET TRAM RAC TRAMSCOPE TRIM KNOB Trimline UNITY logo UNITY NETWORK Vari X Vari X Cardiomatic VariCath VARIDEX VAS and Vision Care Filter are trademarks of GE Marquette Medical Systems Inc registered in the United States Patent and Trademark Office 12SL 15SL Access AccuSpeak ADVANTAGE BAM BODYTRODE Cardiomatic CardioSpeak CD TELEMETRY LAN CENTRALSCOPE Corolation EK Pro EDIC Event Link Cumulus Event Link Cirrus Event Link Nimbus HI RES ICMMS IMAGE VAULT IMPACT wf INTER LEAD LIFEWATCH Managed Use MARQUETTE PRISM MARQUETTE RESPONDER MENTOR MicroSmart MMS MRT MUSE CardioWindow NST PRO NAUTILUS OCTANET 02 SENSOR OMRS PHi Res Premium Prism QUIK CONNECT V QUICK CONNECT QT Guard SMARTLOOK SMART PAC Spiral Lok Sweetheart UNITY Universal Waterfall and Walkmom are trademarks of GE Marquette Medical Systems Inc Revision History This manual is subject to the GE Marquette change order service The revision letter which follows the document part number changes with every update of the manual Part No Revision Date Comment 227 492 04 A January 1999 Initial Release 227 492 04 B March 17 1999 ECO 061 952 227 492 04 C May 7 1999 ECO 062 136 2 MACO 1200 227 492 04 C MAC 1200 Option Codes MAC 1200 Option Codes In addition to the software supplied with the unit optional programs may be pur
27. MAC 1200 Operator s Manual Version 1 227 492 04 GA USA Revision C marquette A GE Medical Systems Company The information contained in this manual describes version 1 0 of the MAC 1200 electrocardiograph and reflects software version 5 0 1999 GE Marquette Medical Systems Inc All rights reserved Trademarked names appear throughout this document Rather than list the names and entities that own the trademarks or insert a trademark symbol with each mention of the trademarked name the publisher states that it is using the names only for editorial purposes and to the benefit of the trademark owner with no intention of improperly using the trademark 900 SC ACCUSKETCH AccuVision APEX AQUA KNOT ARCHIVIST Autoseq BABY MAC C Qwik Connect CardioServ CardioSmart CardioSys CardioWindow CASE CD TELEMETRY CENTRA CHART GUARD CINE 35 COROLAN CORO COROMETRICS Corometrics Sensor Tip CRG PLUS DASH Digistore Digital DATAQ E for M EAGLE Event Link FMS 101B FMS 111 HELLIGE IMAGE STORE INTELLIMOTION IQA LASER SXP MAC MAC LAB MACTRODE MARQUETTE MARQUETTE MAC MARQUETTE MEDICAL SYSTEMS MARQUETTE UNITY NETWORK MARS MAX MEDITEL MEI MEI in the circle logo MEMOPORT MEMOPORT C MINISTORE MINNOWS Monarch 8000 MULTI LINK MULTISCRIPTOR MUSE MUSE CV Neo Trak NEUROSCRIPT OnlineABG OXYMONITOR Pres R Cuff PRESSURE SCRIBE QMI QS Quantitative Medicine Quantitative Sentinel RAC RAMS RSVP SAM SEER S
28. Marquette meet these requirements The specific regulations valid in your country must also be observed 227 492 04 C 3 6 Connecting External Devices Via the serial interface the electrocardiograph can be connected to a MUSE CV Information System These external devices can be connected directly or via a modem Please contact Marquette Application Support for details Resting ECGs acquired in the 12 Lead Mode as well as the corresponding data can be transferred to these external devices see section 5 5 ECG Transmission via Modem The table below shows the system defaults and all possible adjustments For instructions on changing the default setup refer to section 9 6 Communication System defaults Options Choices for Modem Other none user defined MultiTech 19 32 MultiTech 56 6 Elsa 14 4 Elsa 28 8 Elsa 33 6 Choices for Modem user defined AT amp FMO amp DO amp QIVO ATDT ATH Choices for Modem MultiTech 19 32 56 6 ELSA 14 4 ELSA 28 8 33 6 pulse 0 to 9 28 digits 0 to 9 10 digits phone outside line 3 7 Contrast Adjustment e Simultaneously press and the appropriate cursor key more contrast hb less contrast 4 MAC 1200 19 Preparations for ECG Recording prenen Figure 4 1 ECG signal input Warning For reasons of patient safety use only the original Marquette patient cable Before connecting the cab
29. Signal inputs isolated patient signal input IEC type CF high voltage protection for all lead connections and neutral electrode interference compensation via neutral electrode monitoring for open leads e electrode connections for RA LA LL LA V1 to V6 e input impedance for differential signals between any two electrode connections gt 10 MQ at 10 Hz e input impedance for common mode signals referred to neutral electrode gt 50 MQ up to 60 Hz 56 MAC 1200 e dynamic range for differential signals between any two electrode connections for AC voltage 10 mV for superimposed DC voltage polarization voltage 600 mV e dynamic range for common mode signals referred to neutral electrode 1 V referred to chassis 263 V AC rms e quiescent input current via any electrode connection for I kQ termination referred to neutral electrode lt 50 nA e patient leakage current rms values according to IEC class CF in normal condition lt 10 WA in single fault condition e g patient in contact with line voltage lt 20 LA e non destructive range for lead electrode connections and the neutral electrode connection referred to neutral electrode 50 V referred to chassis 1500 V e pulse voltage resistance of all lead electrode connections and of the neutral electrode connection referred to chassis either polarity e g defibrillation 5000 V e monitoring of each electrode for open leads RA LA LL RL V1 V2 V3 V4
30. THE ELECTRODES 4 3 ARTIFACT DUE TO POOR ELECTRODE APPLICATION 4 4 ENTERING PATIENT DATA 5 RECORDING IN 12 LEAD MODE 5 1 SOME BASIC FACTS 5 2 RECORDING 5 3 THE MEMORY FUNCTION 5 4 THE REPORT FORMATS 5 5 ECG TRANSMISSION VIA MODEM 5 6 BRIEF OPERATING INSTRUCTIONS 12 LEAD MODE 6 RECORDING IN 6 LEAD MODE 6 1 SOME BASIC FACTS 6 2 RECORDING 6 3 BRIEF OPERATING INSTRUCTIONS 6 LEAD MODE 7 ARRHYTHMIA MODE 7 1 SOME BASIC FACTS 7 2 RECORDING 7 3 BRIEF OPERATING INSTRUCTIONS ARRHYTHMIA MODE 227 492 04 C MAC 1200 10 12 12 16 17 17 19 19 20 20 20 22 23 25 25 28 29 33 34 34 34 36 37 37 38 40 Contents 8 ECGS OF PACEMAKER PATIENTS ECG RECORDING DURING DEFIBRILLATION 41 9 SYSTEM SETUP 42 9 1 SOME BASIC FACTS 42 9 2 12 LEAD MODE 42 9 3 6 LEAD MODE 44 9 4 ARRHYTHMIA MODE 45 9 5 GENERAL DEVICE SETTINGS 46 9 6 COMMUNICATION 47 9 7 PATIENT DATA 48 9 8 OPTION CODE 48 10 LOADING CHART PAPER 49 11 CLEANING DISINFECTION AND MAINTENANCE 51 11 1 CLEANING AND DISINFECTING THE RECORDER HOUSING 51 11 2 CLEANING AND DISINFECTING THE PATIENT CABLE 51 11 3 CLEANING AND DISINFECTING THE ELECTRODES 51 11 4 MAINTENANCE 52 12 TROUBLESHOOTING 53 13 TECHNICAL SPECIFICATIONS 55 INDEX 61 8 MAC 1200 227 492 04 C Intended Use and Functional Description 1 Intended Use and Functional Description The MAC 1200 is an ECG acquisition and recording system designed and manufactu
31. a Mode Before recording the ECG patient data can be entered KD We recommend to enter the patient s name to annotate it on each page Before initiating a recording check the display for error messages see table at left Check all electrodes if the message persists there must be a break in the patient cable Replace the cable with a new one The recording is started and stopped with the key Upon program start the unit records 6 leads of ECG 1 page During the following learn phase the analysis algorithm learns the patient s typical QRS complex After the learn phase the recorder prints a report where the QRS complexes acquired in the learn phase are labelled L and the complex found to be the patient s typical complex is labelled QRSL Having completed the learn phase the MAC 1200 is ready to identify arrhythmias With the system defaults the MAC 1200 will activate the following functions and settings the STD CH report sequence V1 through V6 configurable again of 10 mm mV configurable calibration pulse at the beginning of the recording The unit can be set up to automatically adapt the gain to the ECG signal auto the AC line filter is enabled configurable the muscle filter is disabled configurable 227 492 04 C Arrhythmia Mode b c d Arrhythmia 40Hz 60Hz ADS Patient Name 25mm s T 10mm mV VI V2 V6 f g h V2 V4 V6 RL HR 120 lt 180 j k Figur
32. an error message Error In this situation notify service to check and repair the device MAC 1200 17 Putting the Device into Operation and Performance Test 3 5 General Device Settings The table at left shows the general device settings that can be modified and the system defaults empty text box selection from a list For instructions on changing the device setup refer of 10 names to section 9 5 General Device Settings Referring empty text box selection from a list Physician of 10 names Technician empty text box selection froma list of 10 names current date Time hh mm Lead Fail Beep Yes sr is Lead Labels IEC LCD light off 5 min 1 to 99 minutes after Default mode 12 Lead 6 Lead Arrhythmia Language English English French Spanish 18 MAC 1200 227 492 04 C Putting the Device into Operation and Performance Test Warning Connecting external devices to the RS232 interface of the electrocardiograph creates a medical system This system must meet the requirements of IEC 60601 1 1 use only the original Marquette connection cables all non medical devices of a system must be connected to the same electric circuit Devices which are not connected to the same circuit must be electrically isolated use isolated RS232 interface as per IEC 60601 1 Modems connected to the electrocardiograph must meet the requirements of EN 60950 or UL1950 all modems recommended by
33. be obstructed The ambient conditions specified in the technical specifications must be ensured at all times DEFIBRILLATOR PRECAUTIONS Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages To ensure proper defibrillator protection use only the recommended cables and leadwires Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation DISPOSAL Dispose of the packaging material observing the applicable waste control regulations and keeping it out of children s reach ELECTROCAUTERY PRECAUTIONS To prevent unwanted skin burns apply electrocautery electrodes as far as possible from all other electrodes a distance of at least 15 cm 6 in is recommended 14 MAC 1200 EMC Magnetic and electrical fields are capable of interfering with the proper performance of the device For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation INTERFACING OTHER EQUIPMENT Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified biomedical engineering personnel that there is no danger to the patient the operator or the en
34. cause complete polarization at the electrode skin interface This condition may prevent ECG signal acquisition for several minutes With silver silver chloride electrodes this will not happen Set the MAC 1200 to 6 Lead Mode when you may have to defibrillate the patient while recording the ECG and disable the anti drift system as this would cause a 2 second signal delay section 9 3 6 Lead Mode If electrodes made of other materials are used disconnect the patient cable from the recorder while the shock is applied Warning For reasons of patient safety use only the original Marquette patient cable Before connecting the cable to the device check it for signs of mechanical damage Do not use a damaged cable Use silver silver chloride electrodes for ECG signal acquisition if the patient may have to be defibrillated The patient signal input of the recorder is protected against damage resulting from defibrillation shocks Nevertheless extreme care should be exercised when defibrillators are used on a patient connected to other devices while a shock is released Observe the safety information of the defibrillator During defibrillation do not touch the patient the electrodes or the leadwires MAC 1200 41 System Setup 9 System Setup 9 1 Some Basic Facts e Press to display the setup menu The main menu with the following options will appear Operating mode 12 Lead 6 Lead Arrhythmia General Se
35. chased to upgraded the MAC 1200 performance features In order to use a new option you need to activate it by entering the option code number refer to section 9 8 for details The option codes are entered into the MAC 1200 prior to shipping Software package Functionality Option Code MEAS measurement measurement of the 10 second resting ECG DIAG interpretation interpretation of the 10 second resting ECG MEMO memory storage of a maximum of 40 10 second resting ECGs C100 activates the three options MEAS DIAG MEMO for a maximum of 100 ECGs C500 activates the three options MEAS DIAG MEMO for a maximum of 500 ECGs EVAL activates the three options MEAS DIAG MEMO for a maximum of 4 weeks me een 227 492 04 C MAC 1200 3 How To Reach Us How To Reach Us Service calls Contact various service supplies and repair personnel using the following telephone numbers and addresses To open a service call with Marquette Service call USA 1 800 558 704 24 hour service 561 575 5000 during U S business hours only Other countries or contact your local sales and service representative Supply products and service parts Order supplies leadwires electrode paste thermal paper etc or service parts circuit boards cables software etc and manuals from Marquette Service and Supplies Attn Supplies or Service Parts P O Box 9100 100 Marquette Drive Jupiter FL 33468 9100 Telephone 1 80
36. chnical Specifications Power switch ON STANDBY Keys to select a higher or lower HR alarm limit Backspace key to correct entered data Confirms entered data Enter Displays the setup menu Enables disables the muscle filter elimination of muscle artifact Selects the writer speed 25 50 5 mm s in 6 Lead Mode and the report formats in 12 Lead Mode Selects the gain 5 10 20 40 mm mV Press to print the report or additional copies of the ECG or to send receive ECGs lanation of symbols used on the device Consult accompanying documents Signal input Type CF signal input highly insulated defibrillation proof 14 15 16 17 18 19 20 21 22 23 24 25 26 27 MAC 1200 Selects the ECG lead in 6 Lead Mode in 12 Lead Mode on the display only Sends ECG to memory retrieves ECG from memory Selects the 12 Lead Mode Selects the 6 Lead Mode Selects the Arrhythmia Mode Starts stops the selected operating mode exits the setup menu and patient data entry Indicators green selected mode started amber selected mode stopped Enables entry of patient data Indicator is illuminated when battery needs to be charged Indicator is illuminated when unit is connected to the power line Cursor control keys Space bar Shift key Press to access special characters Start Stop Putting the Device into Operation and Performance Test 3 Putting the Device into Operation and Performance T
37. cording to IEC 60601 1 e Rated voltage range 95 to 240 V e operating voltage range 85 to 264 V 49 to 65 Hz e rated current 0 2 to 0 6 A e fuse 2 x T1 25A 5x20 e typical power consumption battery charging 14W e max power consumption 29 W Battery operation e type nickel cadmium e rated battery voltage 18 V e rated battery capacity 1 3 Ah e fully charged battery sufficient for up to 50 12 Lead Mode 1 page ECGs if unit is only switched on to record the ECGs e battery charge time approx 4 hours min charge time for one 12 Lead Mode ECG 10 minutes e battery life approx 2 to 3 years replacement by service only e lithium battery for built in clock battery life approx 5 years replacement by service only Operational readiness After successful self test approx 10 s after power up 227 492 04 C Technical Specifications Operating position horizontal Environment Operation e temperature between 50 and 104 F e relative humidity between 25 and 95 e atmospheric pressure between 700 and 1060 hPa Transport and storage e temperature between 22 and 140 F including battery e relative humidity between 25 and 95 e atmospheric pressure between 500 and 1060 hPa Recorder dimensions e width 14 5 in e height 3 7 in e depth 12 6 in incl handle Weight e approx 12 3 Ib with battery 227 492 04 C MAC 1200 59 Technical Specifications For your notes 60 MAC 12
38. e 7 2 Arrhythmia mode display Operating mode Muscle filter enabled AC line filter enabled Anti drift system enabled Patient name a AaS SDa Writer speed event episodes g Trending enabled gt Gain Report sequence Right leg electrode failure message Heart rate Heart rate limit Tip The letter A on a recording indicates the presence of artifact which does not allow the algorithm to identify arrhythmias Causes include wandering baselines The anti drift system largely prevents these disturbances Still you should checke the electrodes and leadwires 227 492 04 C the anti drift system is enabled the automatic baseline adjustment is enabled the slow trend recording is disabled configurable event episodes are recorded at a speed of 25 mm s the unit documents all events that are different from the previous event configurable You can set up the unit to document all events or no event at all All relevant device settings are shown on the display Figure 7 2 The arrhythmia codes annotated on the recording are explained in table 7 1 next page The heart rate limit is automatically calculated from the date of birth WHO 100 220 age When the date of birth is not entered the unit will set the limit at 180 bpm This value can be changed with EF and E in steps of 5 bpm The minimum value for the heart rate limit is 30 bpm MAC 1200 39 Arrhythm
39. e device operates from both AC and DC rechargeable batteries power sources The unit s performance features can be upgraded with the following optional programs MEAS measurement measurement of the 10 second resting ECG DIAG interpretation interpretation of the 10 second resting ECG MEMO memory storage of a maximum of 40 10 second resting ECGs C100 activates the three options MEAS DIAG MEMO for a maximum of 100 ECGs C500 activates the three options MEAS DIAG MEMO for a maximum of 500 ECGs EVAL activates the three options MEAS DIAG MEMO for a maximum of 4 weeks The electrocardiograph has a setup menu to customize the system parameters Patient and user data can be entered for reliable and safe archiving of patient records The patient name is annotated on each printed report page All other data are printed on request Figure 1 1 MAC 1200 MAC 1200 9 Controls and Indicators 2 Controls and Indicators OGGOGOGOGGGG dr es z x c v B n w g gt D Figure 2 1 Controls and indicators of the MAC 1200 electrocardiograph 10 MAC 1200 227 492 04 C A vB N A Aa Il 12 13 Exp A o 227 492 04 C Controls and Indicators Power input Paper door windows allows you to check the paper supply Patient cable connector Serial interface see chapter 13 Te
40. ead Mode 2 AT Command for Establishing a Communication Link Example of a dial string for a modem connected to a branch PBX system and dialling a modem via the public telephone network using the touch tone mode AT prefix that precedes every command line DT touch tone dial mode xxx after DT enter the characters for access to the public telephone network e g 0 0 W W placed after a number tells the modem in a PBX system to wait for the dialtone of an outside telephone line dial string ATDTOW 3 AT Command for Termination of the Communication The communication is terminated in two steps First of all the MAC 1200 sends an escape command to return from the on line state to the command state Then the hangup command follows escape command AT prefix that precedes every command line H hangup command hangup string ATH 227 492 04 C 5 6 Brief Operating Instructions 12 Lead Mode e Switch on the unit and wait for selftest to end e Apply electrodes to patient e Enter patient data Into e Check device settings report sequence report format AC line filter override function 12SL interpretation configuration e Modify device settings if required oe e Wait for patient to lie motionless and for the unit to collect 10 seconds of ECG data e Check that no lead failure message is displayed e Start recording with VO MAC 1200 33 Recording in 6 Lead Mode 6 Recordin
41. es Override function No MAC 1200 25 Recording in 12 Lead Mode right leg electrode disconnected right arm electrode disconnected left arm electrode disconnected left leg electrode disconnected chest electrode V1 disconnected chest electrode V2 disconnected chest electrode V3 disconnected chest electrode V4 disconnected chest electrode V5 disconnected chest electrode V6 disconnected Messages indicating disconnected electrodes 26 5 2 Recording On power up the unit defaults to the 12 Lead Mode system defaults configurable Before recording the ECG patient data can be entered Qt We recommend to enter the patient s name to annotate it on every report After applying the electrodes please wait about 10 seconds for the signal to stabilize stabilization of polarization voltages see section 4 3 Artifact Due to Poor Electrode Application in chapter 4 If you initiate a recording with OD immediately after selection of the 12 Lead Mode a waiting period of 10 to 12 seconds ensues message Collecting data Before initiating a recording check the display for error messages see table at left Check all electrodes if the message persists there must be a break in the patient cable Replace the cable with a new one The MAC 1200 continuously saves 10 seconds of the incoming ECG signal When you initiate a recording with VG the unit prints the most recent 10 seconds
42. est 3 1 Safety Information e This manual is an integral part of the device It should always be kept near the device Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety Please note that information pertinent to several chapters is given only once Therefore carefully read the manual once in its entirety e Patient safety the specified measuring accuracy and interference free operation can be guaranteed only if original Marquette components are used The user is responsible for application of accessories from other manufacturers e This manual is in conformity with the device specifications and standards on safety of electromedical equipment valid at the time of printing All rights are reserved for devices circuits techniques software programs and names appearing in this manual e The terms danger warning and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness Hazard is defined as a source of potential injury to a person Danger indicates an imminently hazardous situation which if not avoided WILL result in death or serious injury Warning indicates a potentially hazardous situation which if not avoided COULD result in death or serious injury 12 MAC 1200 Caution indicates a potentially hazardous situation which if
43. g in 6 Lead Mode 6 1 Some Basic Facts In 6 Lead Mode the system acquires 6 leads of ECG in realtime Recordings are started and stopped with DO Some of the system settings can be customized They are labelled with configurable The following information refers to a unit with the system defaults see table below For instructions on changing the device setup refer to section 9 3 6 Lead Mode Report sequence STANDARD CABRERA SEQ NO 4 Gain 10 mm mV auto 5 20 40 mm mV Muscle filter seer fa 40 Hz 20 Hz ate FS mark ee aa 34 MAC 1200 6 2 Recording After switching on the unit press Ay to select the 6 Lead Mode Before aca the ECG patient data can be entered with inte We recommend to enter the patient s name to annotate it on each page Tip In 6 Lead Mode messages indicating disconnected electrodes are annotated on the recording e g Lead fail V1 Before initiating a recording check the display for error messages see table below Check all electrodes if the message persists there must be a break in the patient cable Replace the cable with a new one right leg electrode disconnected right arm electrode disconnected left arm electrode disconnected left leg electrode disconnected chest electrode V1 disconnected chest electrode V2 disconnected chest electrode V3 disconnected chest electrode V4 disconnected chest electrode V5 disconnected ches
44. he user must have received adequate training in the use of the MAC 1200 and must be capable of applying it properly POWER SUPPLY The device must be connected to a properly installed power outlet with protective earth contacts only If the installation does not provide for a protective earth conductor disconnect the monitor from the power line and operate it on battery power if possible If the installation of this equipment in the USA will use 240V rather than 120V the source must be a center tapped 240V single phase circuit MAC 1200 13 Putting the Device into Operation and Performance Test CAUTIONS MAINTENANCE Regular preventive maintenance should be carried out annually inspections of equipment with measuring functions should be done every two years refer to chapter 11 Cleaning Disinfection and Maintenance PERFORMANCE CHECKS Check the device performance once a month strictly following the instructions outlined in section 3 2 2 Performance Check POWER REQUIREMENTS Before connecting the device to the power line check that the voltage and frequency ratings of the power line are the same as those indicated on the unit s label If this is not the case do not connect the system to the power line until you adjust the unit to match the power source VENTILATION REQUIREMENTS Set up the device in a location which affords sufficient ventilation The ventilation openings of the device must not
45. ia Mode 7 3 Brief Operating Instructions Arrhythmic Events f Arrhythmia Mode asystole limit value ASYSTO ventricular fibrillation flutter VFIB e Switch on the unit and wait for selftest to end ventricular tachycardia e Apply electrodes to patient gt 3 VPBs EE e Select the Arrhythmia Mode en ventricular run 3 VPBs RUN pat ventricular couplet 2 VPBs CPLT one a pause of 2 missed beats PAU2 pause of 1 missed beat PAU1 report sequence early VPB EVPB AC line filter ventricular bigeminy VBIG trend recordings e Check device settings new form e g intermittent bundle branch block NF multiform VPBs arrhythmia report patient ID sheet supraventricular arrhythmia episuderepon paroxysmal supraventricular heart rate alarm limits tachycardia e Modify device settings if required Ep tachycardia e Check that no lead failure message is displayed bradycardia e Start recording with OD pacemaker malfunction nr e Switch on muscle filter with Vite ventricular escape beat 3 D ventricular premature beat SOP ETE ONE wiii supraventricular premature beat e Print patient data with aberrant beat pacemaker capture pause gt 1 5 times the normal RR interval absolute pause limit value artifact learn phase learned QRS complex Table 7 1 Arrhythmia codes 40 MAC 1200 227 492 04 C ECGs of Pacemaker Patients ECG Recording during Defibrillation 8 ECGs of Pacemaker
46. iled results page When selected this page will be appended to the respective report formats It contains patient data measurement results MEAS interpretative statements DIAG medians and the tabular measurement values MAC 1200 29 Recording in 12 Lead Mode 5 5 ECG Transmission via Modem Resting ECGs acquired in 12 Lead Mode can be transferred to host systems MUSE CV Information System version 004A or higher The transfer can take place either directly or via modem RS232 interface For details on modem setup please refer Warning Observe the safety information given in section 3 6 Connecting External Devices to section 3 4 Connecting External Devices After acquisition of the ECG the transmission is initiated with if Manual copy is set to HOST in the setup menu see section 9 2 12 Lead Mode stored ECGs Sen Delete ECG Taken 06 25 98 08 07 38 The recorder is also capable of transmitting stored Print send Delete Change ECGs if MEMO option is installed To retrieve 08 20 98 10 42 27 ECGs from memory hold 8 down while pressing Send Delete Change cee You will see the memory menu Figure 5 6 Print HHHH ete Ht e To transfer all stored ECGs position the cursor on Send All stored ECGs 1 Figure 5 6 to transfer individual ECGs position the cursor on Send of the respective ECG e g 2 Figure 5 6 Figure 5 6 Memory program e Confirm the command with I Yo
47. ime an arrhythmia occurs each time an arrhythmia occurs that is different from the preceding event arrhythmias are not documented all unequal no Patient ID sheet Patient ID sheet included in report yes no Arrhythmia report Final report includes arrhythmic events in tabular format yes no Episodes Final report includes episode report with episodes listed by one of the following criteria inchronological order according to priorities see table 7 1 ventricular beats only no episode report chron prio ventr no MAC 1200 45 System Setup 9 5 General Device Settings Ordering Physician Referring Physician Technician In the field at left you see the last name of the physician or technician selected as the default name When selecting other a menu displays where you can enter up to 10 names 2 digit ID number first name last name The default name and ID is automatically selected at power up The Referring Physician is only relevant if you send ECGs to the MUSE CV system This name will not be_annotated on the ECG recording Press the key to exit the menu Institution Name The name entered here will be printed on each report page Date Time Enter date and time enter 4 digits for the year Lead fail beep Indicates when electrodes are not properly applied or disconnected yes no High HR beep An audible signal sounds when the heart rate
48. ion of the pacer pulse in Arrhythmia Mode Gender Race If you do not intend to enter all demographic data select the neutral entries and unknown Height Weight enter the patient s height in inches and weight in pounds Systole Diastole enter the blood pressure readings in mmHg Phone enter the patient s telephone number Ordering Physician Referring Physician Technician When you choose yes for New patient the default names entered in the General Settings will appear here When you choose other you can pick a name from the list It is also possible to choose no You can press VO to exit the menu The Referring Physician is only relevant if you send ECGs to the MUSE CV Information System This name will not be annotated on the ECG recording Medication enter the patients medications and confirm entries with i Comments 4 lines of 30 characters each 24 MAC 1200 227 492 04 C Recording in 12 Lead Mode 5 Recording in 12 Lead Mode Tip Please bear in mind that no automated analysis of ECG signals is completely reliable Therefore a physician should always overread and reassess the system interpretation before performing patient diagnosis 5 1 Some Basic Facts In 12 Lead Mode 12 leads of ECG are acquired simultaneously for a period of 10 seconds When initiated with Q the acquisition and recording proceed automatically Depending on the implemented software options
49. it from the power line e Discard disposable adhesive electrodes i immediately after use to prevent that they are e Clean the recorder housing with a moist cloth Do Nets reused not let liquid enter the device All cleaning agents and disinfectants that contain alcohol and are e Clean reusable electrodes immediately after commonly used in hospitals are suitable but do removing them from the patient not use disinfectants on a phenol base or peroxide Peel off the adhesive foil before cleaning the compounds electrodes rests of the adhesive can be removed with benzine 11 2 Cleaning and Disinfecting the e Then use warm water and a small brush to clean Patient Cable the electrodes of cream or gel Do not use pointed e Disconnect the cable from the recorder before or sharp objects for cleaning cleaning or disinfecting it When disconnecting e Disinfect the electrodes with alcohol free the cable be sure to pull on the connector not on disinfectant Ensure that connectors and sockets the cable do not become wet e Clean the cable by rubbing it down with a cloth e The only approved sterilization method is gas moistened with soap water Use a disinfectant for sterilization disinfection Do not immerse the cable in liquid Frequently sterilizing the electrodes with ethylene oxide gas reduces the life of the plastic material 227 492 04 C MAC 1200 51 Cleaning Disinfection and Maintenance 11 4 Maintenance
50. le to the device check it for signs of mechanical damage Do not use a damaged cable Caution When the patient may have to be defibrillated while the ECG is being recorded be sure to use only silver silver chloride electrodes Refer to chapter 8 ECG Recording during Defibrillation lt e RA A LA RL fo e LL Figure 4 2 Applying limb lead electrodes 20 MAC 1200 4 Preparations for ECG Recording 4 1 Connecting the Patient Cable Use the 10 leadwire patient cable for acquisition of the 12 standard ECG leads e Connect the patient cable to connector 3 Figure 4 1 4 2 Applying the Electrodes Careful application of the electrodes and skin preparation is the key to an interference free ECG 4 2 1 Applying Electrodes Limb Leads Refer to the illustration shown in Figure 4 2 RA white electrode on right arm LA black electrode on left arm LL red electrode on left leg RL green electrode on right leg 227 492 04 C Preparations for ECG Recording V5 Vi V2V3 V4 Figure 4 3 Chest electrode placement RL green right leg RA white F rightarm Vi red V2 yellow V3 green Eo EI V4 bue V5 orange V6 purple LA black left arm LL red left leg Vi V2V3 V4 Figure 4 4 Connecting the patient cable 10 lead cable standard ECG leads correct wrong Figure 4 5 Arranging the patient cable
51. mats The default format is 4x2 5R1 Detailed results The Detailed results page will be printed yes no section 5 4 The Report Formats only available with option MEAS or DIAG 227 492 04 C System Setup Muscle filter AC line filter Elimination of muscle artifact and AC line interference Default muscle filter No AC line filter Yes Tip Please note that filters may suppress diagnostically relevant portions of the signal Filters should therefore only be enabled if necessary Filter frequency Cut off frequency of the muscle filter 140 Hz 20 Hz The frequency range is indicated in the lower margin of the recording strip 0 08 40 Hz 40 Hz muscle filter enabled 0 08 20 Hz 20 Hz muscle filter enabled 0 08 150 Hz muscle filter off Manual copy to When the lt key is pressed the unit will print a copy of the ECG EKG or send the ECG to a HOST system MUSE CV Information System No of copies If you do not want to print the ECG but only collect data select 0 message on display REC OFF When a number greater than 1 is selected multiple copies of the reports will be printed Default 1 Autosave ECG only with Memory option After report generation the ECG will or will not be automatically saved to the internal memory yes no 227 492 04 C Delete ECG after Transmission only with Memory option ECGs that were successfully sent toa HOST system
52. mmunication Protocol The recorder offers two communication protocols CSI Client Server Interface and A5 The CSI protocol supports the transfer of resting ECGs from the MAC 1200 to the MUSE CV Information System Location only with CSI protocol ID number of the sending system 4 digits Default 1 options 1 to 9999 Site only with CSI protocol ID number of the MUSE CV Information System 2 digits Default 1 options 1 to 99 Baud rate HOST Transmission rate for the selected protocol We recommend the default setting of 19200 baud Options 9600 38400 227 492 04 C Modem Select the modem type You can choose among the standard modems MultiTech MT 19 32 56 6 Elsa 14 4 Elsa 28 8 Elsa 33 6 and a user defined modem When using one of the standard modems all you have to enter is the dial mode pulse or tone depending on your telephone network the telephone number 28 digits max outside line enter the digit for access to the public telephone network e g 0 For a user defined modem enter the telephone number 28 digits max the init string 20 characters max see modem operator s manual the dial string 20 characters max see modem operator s manual the hangup mode 20 characters max see modem operator s manual MAC 1200 47 System Setup 9 7 Patient Data The patient data menu can be set up to meet individual requireme
53. not avoided may result in minor or moderate injury or product property damage e Marquette is responsible for the effects on safety reliability and performance of the device only if assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by Marquette the electrical installation of the relevant room complies with the requirements of the appropriate regulations and the device is used in accordance with the instructions for use The safety statements presented in this chapter refer to the equipment in general and in most cases apply to all aspects of the device There are additional safety statements in the other chapters which are specific to the topic described The order in which safety statements are presented in no way implies order of importance DANGERS EXPLOSION HAZARD Do not use this equipment in the presence of flammable anesthetics vapors or liquids 227 492 04 C Putting the Device into Operation and Performance Test WARNINGS ACCESSORIES SUPPLIES Use only the original Marquette cables Do not connect other signal sources to the cables The responsibility for the use of accessories from other manufacturers lies with the user ACCIDENTAL SPILLS To avoid electric shock or device malfunction liquids must not be allowed to enter the device If liquids have entered a device take it out of service and have it checked by a
54. nts If you do not want to enter blood pressure readings for instance you can remove the corresponding prompts e Use the cursor keys to position the bar cursor on Setup Patient Data and confirm the selection with The patient data setup menu will appear e Select no for prompts that you want to remove from the dialog Items Last name First name Date of birth Patient ID cannot be removed Items Height Weight Diastole Systole Referring Physician Medication are disabled They can be enabled from the patient data setup menu e Press VO to exit the menu 48 MAC 1200 9 8 Option Code In this menu you enter the option codes to enable a number of optional software functions The respective option becomes active after you have entered the code number The code numbers are listed on the option code sheet of the different software options How to activate options e Press to display the setup menu The main menu appears showing the following items Operating mode 12 Lead 6 Lead Arrhythmia General Settings Communication Setup Patient Data Option Code e Using the cursor keys position the bar cursor on Option Code and confirm the selection with D The option code menu appears e Enter the 12 digit code number from the keyboard and exit the menu with e Use the cursor keys to position the bar cursor on Option code and confirm the selection with
55. of ECG data and analyzes it Therefore it is recommended to wait until the patient has been lying relaxed and motionless for about 10 seconds before starting the recording MAC 1200 227 492 04 C Recording in 12 Lead Mode With the system defaults unchanged the unit will activate the following functions and settings after Tip Please note that filters may suppress diagnostically FE relevant portions of the signal Filters should the 12 Lead Mode configurable therefore only be enabled if necessary the standard report sequence I II III aVR aVL aVF VI V2 V3 V4 V5 V6 rhythm leads II V1 and V5 configurable again of 10 mm mV configurable calibration pulse at the beginning of the recording the AC line filter is on configurable the muscle filter is off Ctr configurable b c d e the anti drift system cubic spline is enabled wandering baselines are automatically restored 12Lead 40Hz 60Hz ADS Patient Name to their original position 4x2 5R1 10mm mV Standard the report format is 4x2 5R1 i e 12 leads and g h all data are printed on one page configurable the Detailed results page including the median aVR complexes and the ST measurement results is not printed configurable pressing will print one copy of the ECG aVL configurable units with MEMO option all documented ECGs are automatically saved configurable aVF units with MEMO
56. option after transfer to a HOST system via the RS232 interface the ECGs j are automatically removed from the MAC 1200 memory configurable Jed We the Override Function is enabled configurable Figure 5 1 12 Lead mode display QTC is calculated with the Bazett formula only a Operating mode with option MEAS measurement or DIAG b Muscle filter enabled interpretation c AC line filter enabled All relevant device settings are shown on the display d Anti drift system enabled Figure 5 1 e Patient name The display shows 3 leads at a time With 0 you f Report format or REC OFF when no can successively display all leads of the report recordings are made Gain 10 mm mV sequence in groups of 3 8 ain mm m automatic gain adjustment off The recording can be stopped with VG h Report sequence Fora description of the different reports refer to i Right leg electrode failure message section 5 4 The Report Formats j Heart rate 227 492 04 C MAC 1200 27 Recording in 12 Lead Mode Tip When the unit runs out of paper while printing all stored ECGs menu item Print all stored ECGs gt Q after inserting a new paper pad Then print the remaining ECGs successively or restart a printout of all recordings Print all ECGs ECG Recording of Walker John Print Send Delete Change Figure 5 2 ECG identified by patient name ECG Taken 10 15 98 10 34 12 Print Send Delete Change Figure 5
57. ort Event episodes External equipment connection F Final report Functional description G General device settings General information General settings system setup H Heart rate limit HOST System ID number MUSE Indicators overview Installation Intended use Language Lead fail beep Lead labels Limb lead electrodes application Lithium battery M Mains connection Maintenance Medication Memory optional MEMO function Memory option Modem Modem setup Muscle artifact Muscle filter MUSE CV Information System 36 61 41 30 32 21 28 23 59 59 45 19 45 18 46 39 43 47 10 17 46 46 46 20 53 17 51 24 28 25 30 32 43 43 19 O Option codes Options how to activate Options overview Ordering physician Override function Pacemaker patient Paper feed automatic Paper inserting new pad Patient data setup Patient data entry Performance check Physician referring ordering Power supply Protocols R Receiving ECGs from the MUSE CV system Recharging the battery Recording in 12 Lead mode Recording in 6 Lead mode Recording in Arrhythmia mode Recording problems Referring physician Report formats 12 Lead mode Revision code Revision history 62 Index 3 48 48 24 43 41 44 49 48 23 17 24 46 16 47 32 16 26 34 38 22 24 N MAC 1200 GE Safety information Saving E
58. prox 40 or 20 Hz e with active AC line filter detection and compensation of periodic 50 or 60 Hz frequency components depending on recorder model attenuation gt 40 dB e non linear distortion below values specified in IEC and AHA recommendations 227 492 04 C MAC 1200 e coincidence error limits between any two channels 0 5 mm e detection of pacer pulses in V2 or other V leads and marking in all channels for signals referred to patient input duration gt 0 1 ms amplitude gt 5 mV e noise in the signal transmission path below values specified in IEC and AHA requirements lt 2 5 uV rms e common mode rejection for 50 or 60 Hz signals depending on recorder model with AC filter switched on gt 140 dB ECG calibration automatic recording of a defined voltage step valid for all channels e calibration voltage referred to ECG signal input I mV calibration pulse width on recording depends on paper speed 25 mm s 5 mm 50mm s 10mm 5 mm s I mm Automatic ECG gain adjustment The gain automatically adapts to the incoming signal The maximum amplitude of the lead group or of all leads determines the gain setting e automatic adjustment range 5 to 40 mm mV e amplitude range 6 channels 18 to 31 mm Baseline automatic adjustment of the baseline to the optimal recording range in dependence of the signal amplitude Anti drift system ADS cubic spline automatic compensation of baseline fluctuations cau
59. r month by operating the electro cardiograph on battery power MAC 1200 227 492 04 C Putting the Device into Operation and Performance Test Figure 3 2 Arranging device and couch gt al Figure 3 3 AC power input OOGO 0000C alt 3 Figure 3 4 Power switch Tip When turning off the MAC 1200 standby mode be sure to press the power switch long enough Tip The backlighting of the display switches off automatically when no key is activated for 5 min adjustable 227 492 04 C 3 3 Installation and Mains Connection Figure 3 2 shows a practical arrangement of patient and recorder For interference free operation it is important that the patient cable and the power cord do not run parallel e Using the power cord connect the device to the power line Figure 3 1 Use only the original power cord or an equivalent cable The standby indicator 23 will illuminate e Check the paper supply the window in the paper door allows you to look inside the compartment If it is necessary to insert a new paper pad refer to chapter 10 for instructions 3 4 Performance Check e Press the power switch to switch on the device Figure 3 4 The amber stop indicator Q 20 will illuminate After power up the electrocardiograph runs an automatic self test When no problem is detected it defaults to the 12 Lead Mode If a malfunction is identified the display will show
60. red by Marquette Medical Systems It is intended to be used for resting ECG recording and realtime ECG recording with or without arrhythmia detection It is not intended for use as a vital signs physiological monitor The arrhythmia detection portion of the MAC 1200 is provided to the customer for the convenience of automatic documentation It is not designed to provide alarms for arrhythmia detection The MAC 1200 offers no diagnostic opinion to the user Instead it provides analytical statements when configured with the appropriate options It is intended to be used by trained operators under direct physician supervision when ECG records are required It is suitable for intracardiac application It is designed for continuous operation It is not intended for home use The MAC 1200 is designed as a portable device and can easily be moved from one patient to another or to different locations It is not intended to be used during patient transport Equipped with the standard software the MAC 1200 supports the following operating modes 12 Lead Mode acquisition of 12 leads of ECG for a period of 10 seconds and 6 Lead Mode real time recording of 6 ECG leads Arrhythmia Mode continuous ECG analysis for arrhythmias The graphics display shows 3 leads at a time Resting ECGs can be transferred to the MUSE CV Information System via the RS232 interface 227 492 04 C Th
61. sed by polarization voltage fluctuations at the lead electrodes delay in recording 4 2 s 57 Technical Specifications ECG storage in 12 Lead Mode storage of up to 40 ECGs e stored ECGs can be deleted individually or all in one pass printed transferred and patient data can be edited e when memory is full user is informed of the possible actions Blocking rapid charge reversal of the coupling capacitors in the preamplifiers after electrode application ensures that the baseline is quickly restored to its original position after overranging Electrode monitoring audible and visual indication on the LCD of disconnected electrodes or line break each single electrode is monitored Text input patient and user data as well as comments can be entered via the panel keyboard and are annotated on the recording strip Copy function after ECG recording in 12 Lead Mode copies of the ECG can be printed from memory and or transferred to a MUSE CV system configurable Test automatic performance test upon power up including verification of the signal path starting at the signal input stored test ECG data for demonstration of the device functions Power supply from the power line or from a built in rechargeable battery automatic switchover automatic battery 58 MAC 1200 charging during line power operation from integrated AC adapter module Mains operation e instrument design in protection class I ac
62. speed can be changed with pea Pressing lt will output the patient data after the ECG recording The unit will not advance the paper to the beginning of a new page each time a recording is initiated configurable All relevant device settings are shown on the display Figure 6 1 i Right leg electrode failure message Heart rate k Heart rate limit adjustable lt 227 492 04 C MAC 1200 If you change the writer speed lead group or any filter settings during a recording the unit will briefly stop With 4 you advance to the next group of 6 leads of the selected report sequence 35 Recording in 6 Lead Mode With VJ 1 you toggle between the two lead 6 3 Brief Operating Instructions sets 3 each on the display that belong to the recorded group gt When the anti drift system is enabled there will s be a short delay before the recording starts The ECG will then be recorded with a delay of 2 2 s The heart rate limit is automatically calculated from the date of birth WHO 100 220 age When the date of birth is not entered the unit will set the limit at 180 bpm This value can be changed with EF and E in steps of 5 bpm The minimum value for the heart rate limit is 30 bpm 36 MAC 1200 6 Lead Mode Switch on the unit and wait for selftest to end Apply electrodes to patient Select the 6 Lead Mode W Enter patient data imo Check device settings repor
63. spline continuously checks the baseline position and returns it to the normal level if required Figure 4 6 When electrodes are not properly applied these measures may not fully compensate for artifact High polarization voltages induced by electrodes applied without conductive gel may cause the amplifier to overrange so that a straight line will be recorded instead of the ECG see Figure 4 6 The device will then automatically block and return the baseline to its normal position baseline is then recorded for approx 1 second It is possible to block the amplifiers manually by disconnecting the RL electrode On the display this condition is indicated by instead of the electrode label e g at i Figure 5 1 Remedy e Apply the electrodes according to instructions e Do not apply the electrodes on top of clothing e Use a contact agent with reusable electrodes e g moistened electrode paper electrode cream spray etc e Wait approx 10 seconds before initiating a recording After the 10 second period the automatic functions are enabled and the polarization voltages have stabilized provided the electrodes are properly applied In case of improper electrode application an error message will appear on the display RL LL LA LL V1 to V6 e If required the ADS cubic spline and the filters 20 40 Hz 60 Hz can be disabled to verify the raw ECG signal 4p1 7 lt approx 1s Figure 4
64. t electrode V6 disconnected Messages indicating disconnected electrodes 227 492 04 C Recording in 6 Lead Mode Tip Please note that filters may suppress diagnostically relevant portions of the signal Filters should therefore only be enabled if necessary Before and during the recording the second set of 6 leads can be selected with the ap key b c d 6 Lead 40Hz 60Hz ADS Patient Name 25mm s 10mm mV I IL III aVR aVL avF D o aVR aVL aVF HE PE AG ER i j k Figure 6 1 6 Lead mode display Operating mode Muscle filter enabled AC line filter enabled Anti drift system enabled Patient name Writer speed Gain 10 mm mV automatic gain adjustment off wm AF MALER Report sequence The recording is started and stopped with With the system defaults the MAC 1200 will activate the following functions and settings the standard report sequence I II I aVR aVL aVF V1 V2 V3 V4 V5 V6 also available CABRERA SEQ NR 4 custom report sequence a gain of 10 mm mV configurable calibration pulse at the beginning of the recording The unit can be set up to automatically adapt the gain to the ECG signal see section 9 3 6 Lead Mode Also the gain setting can be changed with 5 10 20 and 40 mm mV the AC line filter is enabled the muscle filter is disabled the anti drift system cubic spline is disabled configurable the writer prints at a speed of 25 mm s the
65. t sequence AC line filter ADS cubic spline heart rate alarm limits Modify device settings if required av Watch ECG on display Check that no lead failure message is displayed Start recording with VO Proceed to the next group of 6 leads with 4 Change the writer speed with ea Switch on muscle filter with iier Stop the recording with VO Print patient data with lt 227 492 04 C Arrhythmia Mode Figure 7 1 Event recording Tip After starting the program press Sonat to select a continuous recording with a speed of 5 mm s configurable If the unit identifies an arrhythmic event it will automatically switch to the fast paper speed With the same key Game the trend recording can be stopped The unit can be set up to automatically start a trend recording when the Arrhythmia Mode is initiated Report sequence STD RED II chest leads V1 IM V2 V4 V6 STD LI f II M aVR aVL aVF CABR LI aVL I aVR II aVF III SEQ No 6 V1 through V6 Gain 10 mm mV auto 5 20 40 mm mV serie RO es pe Res e p Lc Ke Ye No Ye No No S S gt 5 227 492 04 C 7 Arrhythmia Mode 7 1 Some Basic Facts In Arrhythmia Mode the MAC 1200 continuously scans the ECG for arrhythmias From six simultaneously acquired leads the MAC 1200 automatically selects the two that provide the best signal for analysis When the analysis algorithm detects an arrhythmia
66. ted Recorder operating on battery power battery depleted Connect recorder to the power line After a few minutes the recorder is able to resume operation Always connect recorder to the power line when the battery low indicator 22 lights up The battery capacity depends on age temperature and charge level chapter 3 Putting the Device into Operation No recording in 12 Lead Mode At least one electrode is off the patient Check all electrodes or enable Override function section 9 2 12 Lead Mode MAC 1200 227 492 04 C Technical Specifications 13 Technical Specifications Recording Direct recording of waveforms and alphanumeric characters with rectangular coordinates by means of thermal array printhead printing on thermosensitive paper e 3 or 6 recording channels or 12 in 12 Lead Mode overlapping e baseline pitch 3 channels 62 mm arrhythmia 6 channels 31 mm 6 Lead 12 channels 16 mm 12 Lead e writing width 200 mm max e annotation of recorder settings date time and entered patient name in the margin of the recording strip e with appropriate software documentation of analysis results in the respective operating mode e resolution of the recording vertical 8 dots mm horizontal 25 um at 25 mm s Printer paper Marquette CONTRAST Z fold pad 150 pages per pad equivalent to a chart length of approx 45 m paper width 8 5 inch sheet length 11 inch To prevent damage to the
67. the ECG is only printed out options MEAS measurement DIAG interpretation not implemented is measured and printed out with the measurement results with option MEAS measurement is measured interpreted analyzed and printed out with the interpretative statements with option DIAG interpretation Units equipped with the optional Memory function can save up to 40 resting ECG These ECGs can be printed or sent to the MUSE CV Information System CSI protocol see section 5 3 The Memory Function The unit offers different report formats for printout of the ECG With the system defaults all 12 leads including the measurement and analysis results will be documented on a single page see section 5 4 The Report Formats 227 492 04 C Several system settings can be customized In this manual they are labeled configurable The following information refers to a unit with the system defaults see table below For instructions on changing the system setup refer to section 9 2 12 Lead Mode Report sequence STANDARD _ CABRERA Rhythm leads IL V1 V5 I M aVR aVL aVF V2 V3 V4 V6 Gain 10 mm mV xauto 5 20 40 mm mV Report format 4x2 5R1 1x10R12 2x5R1 2x5_50 4x2 5R1 1x10R3 4x2 5R3 Detailed results Yes Manual copy to EKG No of copies Auto save ECG Delete ECG after transm Use screen crit Suppr normal st Suppr abnormal No interpretation Y
68. ttings Communication Setup Patient Data Option Code At Operating mode you will always see the currently selected mode So be sure to select the appropriate mode before entering the setup menu e To access the menu options position the bar cursor on the option with the cursor keys and confirm the selection with The operating steps to select a setting are always the same e Using the cursor keys lt and you select the option then you confirm the selection with D The cursor will move to the next menu item e Individual items can be skipped with 4 or Gp e Press OD to exit the setup mode 6000 20 J Une PG Figure 9 1 System setup keys 42 MAC 1200 9 2 12 Lead Mode e Use the cursor keys to position the bar cursor on 12 Lead and confirm the selection with The setup menu for automatic 12 lead recording will appear The angular brackets denote the system defaults Report sequence STANDARD 1 II II aVR aVL aVF V1 V2 V3 V4 V5 V6 CABRERA aVL I aVR IL aVF III V1 V2 V3 V4 V5 V6 Rhythm leads Any three of the available ECG leads can be selected as rhythm leads They are printed with report formats 4x2 5R3 and 1x10R3 Formats 2x5R1 and 4x2 5R1 will show only the first of the rhythm leads Gain 5 10 20 40 mm mV auto Report format For an overview of the available report formats refer to section 5 4 The Report For
69. u will see the transmission menu as shown in Figure 5 7 e Check the displayed telephone number and press to initiate the transfer Start transmission ENTER NG Modify settings SETUP e Ifitis necessary to change the number press ene Cancel START STOP to display the setup menu e With VO the transmission can be stopped Figure 5 7 Transmission menu Tip The MAC 1200 can be set up to automatically store the ECG after acquisition or to automatically delete the stored ECG after transmission 30 MAC 1200 227 492 04 C Recording in 12 Lead Mode s soon as you initiate the transfer with T the unit will automatically dial the number of the modem at the receiving end and establish a connection Figure Cancel START STOP 5 8 Then it will send the ECG Figure 5 9 After the transfer the standard screen display Figure 5 8 Initializing the transmission APpearS AGAIN If it is not possible to transfer the ECG wrong CSI modem setup modem off the unit will display an ECG Transmission F error message such as Transmission error CSI Cancel START STOP Figure 5 10 In this situation you have the following choices Figure 5 9 Display during ECG transfer you can repeat the transmission with D you can change the settings with you can stop the transmission with VG Try again ENTER Modify settings SETUP Cancel START STOP Figure 5 10 Error message
70. vironment as a result In those instances where there is any element of doubt concerning the safety of connected devices the user must contact the manufacturers concerned or other informed experts for proper use In all cases safe and proper operation should be verified with the applicable manufacturer s instructions for use and system standards IEC 60601 1 1 EN 60601 1 1 must be complied with 227 492 04 C Putting the Device into Operation and Performance Test NOTES The MAC 1200 is designed to comply with IEC 60601 EN 60601 requirements It is Class I equipment and has a built in rechargeable electrical power source The device is suitable for intracardiac use The device is suitable for continuous operation Choose a location which affords an unobstructed view of the monitor s screen and easy access to the operating controls The MAC 1200 has no additional protection against ingress of water Medical technical equipment such as the MAC 1200 must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly At the end of its service life the MAC 1200 and its accessories must be disposed of in compliance with the special waste control regulations for electronic parts If you have any questions in this matter please contact Marquette Medical Systems 227 492 04 C Literature Medical Device Directive 93 42 EEC EN 60601 1 1990 A

- GTS Medical, Inc.

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