MAC 1200 Opeartors Manual sw ver 6 Rev G July 2014

NOTE: The information in this manual only applies to MAC 1200 software version 6. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. MAC, MUSE and 12SL are trademarks owned by GE Medical Systems, Information Technologies, a General Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners. ©2002 - 2009, 2012, 2014 General Electric Company. All rights reserved.

T-2

MAC 1200

2012250-022G 9 July 2014

Compliance

Compliance

Any other directive(s) and all the standards the product complies to are listed in the general information of the operator manual for the product following this page. The country of manufacture can be found on the equipment labeling. The product is in radio-interference protection class A in accordance with EN 55011. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.

Exceptions The MAC 1200/1200 ST EMC: Immunity Performance Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.

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Compliance General Information

Compliance-2

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The device is designed to comply with IEC 60601 requirements. It is a protection class I device.

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The information contained in this manual reflects software version 6.

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Contents

1

The Basics... 1-1 About This Manual... 1-3 Revision History... 1-3 Manual Purpose... 1-3 MAC 1200 Resting ECG Analysis System Option Codes... 1-4 Intended Use and Functional Description... 1-5 Intended Audience... 1-7 Definitions... 1-7 Illustrations and Names... 1-7 Safety Information... 1-8 Definitions... 1-9 Underwriters Laboratories, Inc... 1-12 Biocompatibility... 1-13 Literature... 1-13 Service Information... 1-14 Requirements... 1-14

2

Controls and Indicators... 2-1 General Information... 2-3 MAC 1200 Control Panels... 2-3 MAC 1200 Keyboard... 2-4 Symbols... 2-6

3

Operating and Performance Tests... 3-1 Power Supply... 3-3 Installation and Mains Connection... 3-4 Performance Check... 3-5 Contrast Adjustment... 3-6 System Setup... 3-7

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Connecting Peripheral Equipment... 3-8

4

Preparing for ECG Recording... 4-1 Connecting the Patient Cable... 4-3 Electrode Application... 4-4 Applying Plate (Limb) Electrodes... 4-5 Applying Suction Electrodes (Chest)... 4-5 Electrode Placement for Standard Leads (l, II, III, aVR, aVL, aVF, V1...V6)... 4-6 Artifact Due to Poor Electrode Application... 4-8 Entering Patient Data... 4-10 New Patient... 4-12 Last Name, First Name... 4-12 Date of Birth... 4-12 Patient ID... 4-12 Chest Pain... 4-13 Pacemaker... 4-13 Gender/Race... 4-13 Height/Weight... 4-13 Systolic BP/Diastolic BP... 4-13 Ordering Physician / Referring Physician / Technician... 4-14 Phone Number... 4-14 Medication... 4-14 Comments... 4-14 ID Required... 4-14 Secondary ID... 4-14 Secondary ID Required... 4-15 Last/First Name Required... 4-15 Location Number... 4-15 Room... 4-15 Order Number... 4-15 Prompts... 4-15

5

Recording in 12 Lead Mode... 5-1 General Information... 5-3 Recording... 5-5 The Storage Program... 5-8 Report Formats... 5-10 Detailed Results... 5-11 ECG Transmission... 5-12

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General Considerations... 5-12 Transmission via Modem... 5-12 Batch Transmission... 5-15 Transmission Log... 5-15 Transmitting Data to a MUSE CV System Via Modem... 5-16 Receiving Data... 5-19 Cart to Cart Communication... 5-20 Modem Setup (for Modem ® Other)... 5-20 Adjusting Measurement Points/QT Dispersion... 5-22 Global Measurement Points... 5-22 Local T Offset Measurement Point/QT Dispersion... 5-24 Brief Operating Instructions – 12 Lead Mode... 5-26

6

Recording in 6 Lead Mode... 6-1 General Information... 6-3 Recording... 6-4

7

Arrhythmia Mode Recording... 7-1 General Information... 7-3 Recording... 7-5 During the Recording... 7-6 Final Report... 7-8

8

Pacemaker Patients / Recording During Defibrillation . 8-1 Recording ECGs of Pacemaker Patients... 8-3 ECG Recording During Defibrillation... 8-4

9

System Setup... 9-1 General Information... 9-3 12 Lead Mode... 9-5 Report Sequence... 9-5 Rhythm Leads... 9-5 Gain... 9-5

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Report Format... 9-5 Detailed Results... 9-5 Continuous Rhythm... 9-6 Muscle Filter/AC Filter... 9-6 Muscle Filter Frequency... 9-6 Manual Copy To... 9-6 Number of Copies... 9-7 Interpretation... 9-7 Print Interpretation... 9-7 Override Function [no]... 9-8 6 Lead Mode... 9-9 Report Sequence... 9-9 Gain... 9-10 Speed... 9-10 Muscle Filter/AC Filter... 9-10 Muscle Filter Frequency... 9-10 Anti-Drift System (ADS)... 9-11 Auto Paper Feed... 9-11 Arrhythmia Mode... 9-12 Report Sequence... 9-12 Gain... 9-12 Muscle Filter... 9-12 AC Filter... 9-12 Muscle Filter Frequency... 9-13 Trend Recording... 9-13 Arrhythmia Data... 9-13 Episodes... 9-13 Pharma... 9-14 Patient Data Customization... 9-14 Project Code... 9-15 Trial ID... 9-15 Investigator ID... 9-15 Visit Number... 9-16 Visit Type... 9-16 Dose Type... 9-16 Extra Questions... 9-16 High Security... 9-17 Device Password... 9-17 Don’t Allow Record Edits... 9-18 Delete Only After Transmission... 9-18 Force Technician Name... 9-19 System Setup... 9-20 Ordering Physician/Referring Physician/Technician... 9-20 Institution Name... 9-20 Cart Number... 9-20 Site Number *... 9-20

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Location*... 9-21 Date/Time... 9-21 Lead Fail Beep... 9-21 High HR Beep... 9-21 Lead Labels... 9-21 Pace Enhancement... 9-21 Baseline Roll Filter... 9-21 Date... 9-22 Time... 9-22 Units... 9-22 Mains... 9-22 LCD Light Off After... 9-22 Low Battery Beep... 9-22 Default mode... 9-22 Language... 9-22 Enable Password Protection... 9-23 Test Data... 9-23 Restore Defaults... 9-23 Print Setup Lists... 9-23 Transmission Log... 9-23 Check Record Retxn... 9-24 Communication... 9-25 Baud Rate (PC)... 9-25 Protocol... 9-25 Modem... 9-25 PIN Dialing... 9-26 Patient Data Menu Setup... 9-27 Required Data Fields... 9-28 Extra Questions 1 to 4... 9-28 Option Code... 9-29 ECG Transmission via Modem... 9-30 Selecting the Communication Protocol... 9-30 Direct ECG Transmission... 9-31 Selecting the Communication Protocol... 9-31

10

Loading Chart Paper... 10-1 Procedure... 10-3 End-of-Paper Indication... 10-5 Aging Stability... 10-6

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11

Cleaning, Disinfection and Maintenance... 11-1 Cleaning and Disinfecting the Recorder Housing... 11-3 Cleaning and Disinfecting the Patient Cable... 11-3 Cleaning and Disinfecting the Electrodes... 11-3 Maintenance... 11-4 Checks Before Each Use... 11-4 Technical Inspections... 11-4 Disposal... 11-4

12

Troubleshooting... 12-1 Troubleshooting Chart... 12-3

13

Technical Specifications... 13-1 Recording... 13-3 Printer Paper... 13-3 Paper Transport... 13-3 Membrane Keypad... 13-3 Display... 13-4 Indicators (LEDs)... 13-4 Lead Selection... 13-4 Automatic Functions... 13-4 Detection of Pacer Pulses... 13-5 Heart Rate Indication... 13-5 Signal Inputs... 13-5 Data Interface... 13-6 Transfer of ECGs... 13-6 Receiving Data with the CSI Communication Protocol from the Following Units 13-6 Sending ECGs to the Following Units with the A5 Protocol... 13-6 Remote Start (Hardware)... 13-7 Signal Transmission... 13-8

14

Order Information... 14-1 General Information... 14-3 Options... 14-3 General Accessories... 14-3

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Entering Special Characters...A-1 Special Characters... A-3

Index... Index-1

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1

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The Basics

MAC 1200 2012250-022

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For your notes

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MAC 1200 2012250-022

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The Basics: About This Manual

About This Manual Revision History This manual has a revision letter, located at the bottom of each page. This revision letter changes whenever the manual is updated. Revision A is the initial release of the document. Revision

Date

A

31 March 2003

Initial release of manual, describes version 6.0.

Comments

B

21 July 2004

Revised CE compliance information, High Security “memory full” information added.

C

14 September 2007

Revised Document Assembly Worksheet to add Hg Symbol Description Addendum to English manual only.

D

13 October 2008

Updated T-2 page. Added Proper Leadwire Connection Caution in Safety Information section.

E

30 December 2009

Updated Maintenance Section, “Technical Inspection" for compliance purposes and added note regarding implantable devices.

F

31 July 2012

Manual essential classification was updated in PDM tool; no change to content of the manual.

G

9 July 2014

Manual updated for RoHS regulatory non-compliance.

Manual Purpose This manual describes the safe and effective operation of the MAC 1200 unit. NOTE This document describes the functionality of the U.S. interface for the MAC 1200 unit. Information in this manual differs from operating information for MAC 1200 units developed for use internationally. Please refer to PN 2012250-021 for information on using the international interface.

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The Basics: MAC 1200 Resting ECG Analysis System Option Codes

MAC 1200 Resting ECG Analysis System Option Codes In addition to the software supplied with the unit, optional programs may be purchased to upgrade 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 “Option Code” on page 9-29 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

____________

Serial No:

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The Basics: MAC 1200 Resting ECG Analysis System Option Codes

Intended Use and Functional Description The MAC 1200 is an ECG acquisition and recording system designed and manufactured by GE Medical Systems Information Technologies. 

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 not 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),



6 Lead Mode (realtime recording of 6 ECG leads), and



Arrhythmia Mode (continuous ECG analysis for arrhythmias).

The graphics display shows 3 leads at a time. Resting ECGs can be transferred to the CardioSys/CardioSoft or MUSE CV Information System via the RS232 interface. The device operates from both AC and DC (rechargeable batteries) power sources.

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The Basics: MAC 1200 Resting ECG Analysis System Option Codes

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 period of 4 weeks

The MAC 1200 resting ECG analysis system 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 is printed on request.

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The MAC 1200 units are designed to comply with IEC 60601 / EN 60601 requirements. They are protection class I devices/devices with an internal power source. They are classified as MDD class IIa devices. They are designed for continuous operation. The units are not suitable for intracardiac application. The units are not intended for use as vital signs physiological monitors.

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MAC 1200 2012250-022

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The Basics: MAC 1200 Resting ECG Analysis System Option Codes

Intended Audience This manual is geared for clinical professionals. Clinical professionals are expected to have working knowledge of medical procedures, practices, and terminology as required for monitoring of critically ill patients. CAUTION PATIENT HAZARD - Medical technical equipment such as the MAC 1200 must only be used by qualified and trained personnel.

Definitions The following formats are used in this manual to highlight various web viewer features and functions. Black text

Indicates keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment.

Italicized text

Indicates software terms that identify menu items, buttons, or options in various windows.

Ctrl+Esc

Indicates a keyboard operation. A (+) sign between the names of two keys indicates that you must press and hold the first key while pressing the second key once. For example, “Press Ctrl+Esc” means to press and hold down the Ctrl key while pressing the Esc key.

<Space>

Indicates you must press the space bar. When instructions are given for typing a precise text string with one or more spaces, the point where the space bar must be pressed is indicated as: <Space>. The purpose of the < > brackets is to ensure you press the space bar when required.

Enter

Indicates you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor. In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.

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The Basics: Safety Information

Safety Information 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. The symbol means: Consult accompanying documents. It indicates points which are of particular importance in the operation of the device. 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. On request GE will provide a service manual. The GE quality management system complies with the standards DIN EN ISO 9001 and EN 46001. To ensure patient safety, the specified measuring accuracy, and interference-free operation, we recommend to use only original GE components. The user is responsible for application of accessories from other manufacturers. The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers. GE is responsible for the effects on safety, reliability, and performance of the device, only if

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

assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE or by persons authorized by GE, and



the device is used in accordance with the instructions given in this operator's manual.

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