MACi Safety and Warning Guide Rev C

MAC™ i Resting ECG System-Safety and Warnings Guide © 2009, 2011, General Electric Company. All Rights Reserved

Caution

Description

Proper lead wire connection

Improper connection will cause inaccuracies in the ECG. Trace each individual lead wire from its acquisition module label to the colored connector and then to the proper electrode to ensure that it is matched to the correct label location.

Before installation

Equipment damage

Electric shock

Power requirements

Low battery shut down

Serviceable parts

Supervised use

Compatibility is critical to safe and effective use of this system. Please contact your local sales or service representative prior to installation to verify equipment compatibility. Devices intended for emergency application must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site. Wait until all moisture has vaporized before using the system. To reduce the risk of electric shock, do NOT remove cover (or back). Refer servicing to qualified personnel. Before connecting the system to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the AC/ DC adapter’s label. If not, do not connect the system to the power line. This equipment is suitable for connection to public mains as defined in CISPR 11. After low battery shutdown, if the battery is not charged for a long period of time, the system shifts to a second level of deep discharge protection. Charge the battery for a minimum of half an hour before using system. We recommend that you keep the unit charged to avoid a low-battery shut down. This equipment contains no user serviceable parts. Refer servicing to qualified service personnel. This equipment is intended for use under the direct supervision of a licensed health care practitioner.

General information RECORDING ECGS DURING DEFIBRILLATION This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery, as required by test standards. The patient signal input of the acquisition module is defibrillation-proof. It is not necessary to remove the ECG electrodes prior to defibrillation. When using stainless steel or silver electrodes, a defibrillator discharge current may cause the electrodes to retain a residual charge causing a polarization or DC offset voltage. Electrode polarization blocks acquisition of the ECG signal. If a defibrillation procedure is necessary, use non-polarizing electrodes, such as silver/silver-chloride types, to avoid a DC offset voltage when subjected to a DC current. If using polarizing electrodes, disconnect the lead wires from the patient before delivering the shock. Electrode defibrillation recovery allows the ECG trace to return after defibrillation.

RECORDING ECGS OF PACEMAKER PATIENTS

Symbol

The system does not support pacer pulse detection. WARNING: PATIENT HAZARD -If several adverse conditions exist at once, pacer pulses might be interpreted and counted as QRS complexes. Pacemaker patients should always be watched closely.

Description/Function

EQUIPMENT IDENTIFICATION

Do not throw or dispose of in fire!

Every GE Healthcare device has a unique serial number for identification on the device label.

ACCURACY OF THE INPUT SIGNAL REPRODUCTION Overall system error is tested using the method described in AAMI EC11 3.2.7.1. Overall system error is ± 5%. Frequency response is tested using the method described in AAMI EC11 3.2.7.2 methods A and D.

Contains "Lithium Ion”. This symbol indicates “General recovery/recyclable” and must not be disposed of as unsorted municipal waste and must be collected separately.

MODULATING EFFECTS IN DIGITAL SYSTEMS

Manufacturer name and address.

This system uses digital sampling techniques that may produce some variation in amplitudes of Q, R, and/or S waves from one heart beat to the next. These variations may occur more in pediatric recordings. If this variation is observed, be aware that the origin of amplitude variations is not entirely physiologic. For measuring voltages of Q, R, and S waves, use the QRS complexes with the largest deflection of the particular waves.

Date of Manufacture (Year-Month).

INGRESS PROTECTION

LOT Code.

The system is not protected against ingress of liquids or materials, care should be taken to avoid accidental spills or ingress of materials into the system. Catalogue number (Part number).

PARTS AND ACCESSORIES To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare. Parts and accessories must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards.

Product code is SFD

B

Year manufactured (00-99) 00 = 2000, 01 = 2001, and so on

C

Fiscal week manufactured

D

Production sequence number

E

Manufacturing site

F

Miscellaneous characteristic

Serial number.

EQUIPMENT SYMBOLS European authorized representative. Symbol

Description/Function Type CF equipment. The acquisition module is protected from defibrillation shocks.

The packaging of this product can be recycled.

Consult instructions for use. Humidity limitation. Consult accompanying documents for cautions. Atmospheric pressure limitation. Classified with respect to electric shock, fire, mechanical, and other specified hazards only in accordance with UL 60601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-2-25, IEC 606011, IEC 60601-1-2, IEC 60601-2-51.

Indicates the temperature limitations for the transportation and handling of this package.

(enclosed equipment without protection against

Class II equipment

ingress of water).

Indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

SERVICE REQUIREMENTS Refer equipment servicing to GE Healthcare authorized service personnel only. Any unauthorized attempt to repair equipment under warranty voids that warranty. It is the user responsibility to report the need for service to GE Healthcare or an authorized agent.

MACi Resting ECG System Guides 0459

A

2047427-001

Page 2 of 8 Revision C

MAC™ i Resting ECG System-Installation and Setup Guide ©2009, 2011, General Electric Company. All Rights Reserved

The MAC™ i Resting ECG System Installation and Setup Guide provides instructions for initial installation and setup of your system. NOTE: MACi system is user installable.

Before you begin Remove the system and accessories from the box, and keep on a flat dry surface, away from direct sunlight, heat sources and dust.

Instructions to load roll paper: 1. Open the printer door. 2. Remove any leftover from the printer pocket. 3. Place the roll, with the print side (red grid) facing the thermal printhead, into the compartment. 4. Unroll the beginning of the paper and close the door. Make sure that the paper is exactly positioned on the pressure roller and that the door locks into place on both sides. NOTE: A red line at the top of the sheets indicates that the paper supply is low. Change paper as needed.

E. Turning on the System

E

C - Configuration Settings

F

Hz (bottom)

G

mm/mV

Sensitivity (gain) in millimeters per millivolt: (10 mm/mV).

H

mm/s

Paper speed: in millimeters per second (25 mm/s).

I

A. Confirming the Standard box contents The box should contain the following: • MAC™ i resting ECG system • Four limb clamp electrodes • Six bulb electrodes • Patient ECG cables/lead wires • Power Supply • Roll Paper • Electrode cream • CD containing a service manual • User guide

B. Charging the battery The MAC™ i system needs a charged battery to print an ECG. Charge the battery for three hours for full power. A fully charged battery allows for 250 continuous single channel ECGs, 500 continuous three channel ECGs (optional) or 4 hours of continuous Rhythm recording in default condition. When operating from battery, the system provides a conservation mode whereby the system automatically turns off if the device is not printing or no key is activated for 10 minutes. The shut down is equivalent to powering down the system. NOTE: The system operates on internal rechargeable battery or mains power. The system will not acquire or print an ECG if it is connected to the AC power supply. Acquisition and print will happen only on internal rechargeable battery. Instructions to charge the battery: 1. Connect the system (A) to a power source on the rear side panel using the power supply (12V @ 2.08Amp) supplied with the accessory starter kit.

Press the Power Button to turn on the system. When the system is turned on verify the following: • The ON/OFF LED lights up. • On the screen, the product name MACi is displayed. • Software version is displayed soon after the product name. • The default startup screen appears without any errors. If you encounter any problems powering on the system, refer to Maintenance guide for troubleshooting instructions.

F. Recording an ECG

After charging for three hours, unplug the power cord from both the system and the power source. Recharge when you see the blinking yellow LED above the battery symbol.

When you turn on the system, the system default is ECG mode. Factory defaults have the following functions and settings (the most important settings are indicated on the display):

A

C

B

Rotating symbol: Displays when the ECG data acquisition or recording is active.

A J

Prog

D

I

H

G

Symbol

When the system is turned on, setup the system for initial use by following the instructions given in this section.

Start/Stop or ECG Key

The following table describes the settings with the symbols on the default startup screen:

The green LED below the DC symbol glows when the system is connected to an external power source.

B

The yellow LED glows when the battery is being recharged and it switches off once the battery is fully charged. When the battery power is low the yellow LED blinks.

C

The green LED below the power on symbol glows when the system is switched on.

Setting parameters for Startup screen menu Power Button Enter Key

Navigating the start up screen menu

1. To navigate within the startup screen menu use the cursor keys on the arrowpad. 2. To select the required parameter, press the Enter key. 3. To change the value of the selected parameter, use cursor keys on the arrowpad. This will display the list of valid values. 4. To confirm selection, press Enter key.

A

Symbol

C

Menu Item

Options [ECG] RHY

The system can be operated in ECG or Rhythm mode.

Speed (in mm/s)

ECG MODE [25] 50 RHY Mode [25] 50 5

Changes the speed of the waveform on the display and printout.

Gain (in mm/mV)

2.5 5 [10] 20

The larger the selected measurement, the larger the waveform appears. Only the appearance of the waveform changes; signal strength is not affected.

Filter

[Off] 40 20

Selecting a frequency eliminates signals that exceed that frequency. The smaller the frequency selected, the more signal is filtered out. For example, a filter of 40 Hz displays only signals at 40 Hz or less; signals greater than 40 Hz will be ignored.

Description

Cursor Down: Press to move the cursor down.

Cursor Right: Press to move the cursor right.

Cursor left: Press to move the cursor left.

AC filter: On (enabled) (50 Hz).

MACi Resting ECG System Guides 2047427-001

Description

Mode

Cursor Up: Press to move the cursor up.

Heart rate: Detects the patient’s heart rate. Hz (top)

NOTE: Angular brackets [ ] identify default setting

Power Button: Press to switch on/off the unit.

Lead fail indicator: Indicates a disconnected electrode or patient cable. For example, “^^” indicates that patient cable is disconnected, LA indicates that the left arm electrode is disconnected.

The MACi system supports the use of standard thermal recording roll paper.

D

Description ECG Report Format or lead indicator: Sim 1, Sim 3, Seq 1, Seq 3 channel simultaneous report format in ECG mode Printable lead (I, II, III, aVR, aVL, aVF, V1V6) in Rhythm mode.

D. Loading paper

The following table gives you the valid values you can choose and set for each menu item on the startup screen.

WARNING PATIENT HAZARD -The MACi system is not intended for use as a vital signs physiological monitor. When needed, use a device intended for vital signs monitoring.

System symbols Symbol

Description

A

Arrowpad

Use these guidelines to help you navigate the menu using the keypad. The following figure shows the keypad of MACi. For more information refer to the section System symbols.

F

C

B

Operating mode: ECG, RHY.

Setting up the System for operation

E

B

0459

About the LEDs

Default Startup Screen

C. Hooking up the starter Kit Connect the patient cable to the system (B) on the right side panel.

Start/Stop or ECG key: Press to start or stop a recording and to clear error messages.

Muscle filter: Off (disabled) (Hz)

Your system is now ready to use. Press the Start/Stop or ECG key to record an ECG. NOTE 1: Throughout this document Start/Stop or ECG key will be used interchangeably. NOTE 2: The system displays DOOR OPEN message if the printer door is open. System cannot be operated and ECG cannot be taken in this condition.

J 2.

Enter key: Select a parameter and press Enter key to confirm your selection.

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MAC™ i Resting ECG System-Installation and Setup Guide ©2009, 2011, General Electric Company. All Rights Reserved

Menu Options Print Lead

Options

Description

ECG Mode [Sim 1] Seq 1 Sim 3 (Optional) Seq 3 (Optional)

Selects which leads to include in the printout.

Print Lead 1. Place the cursor before the position indicated by label A. 2. Press the Enter key. 3. Use the cursor keys to navigate through the list of options. 4. Press Enter when the desired value is displayed on the screen.

RHY Mode [I] II III aVR aVL aVF V1 V2 V3 V4 V5 V6

System Setup The system setup function allows you to customize many of the MACi system settings. Once you customize and save your settings, they will activate each time you turn on the system.

D

C

B

E

J

I

H

G

Adaptive Filter

F

Mode 1. Place the cursor before the position indicated by label J. 2. Press the Enter key. 3. Use the cursor navigation keys to navigate through the list of options. 4. Press Enter when the desired value is displayed on the screen. Speed 1. Place the cursor before the position indicated by label H. 2. Press the Enter key. 3. Use the cursor keys to navigate through the list of options. 4. Press Enter when the desired value is displayed on the screen.

Gain 1. Place the cursor before the position indicated by label G. 2. Press the Enter key. 3. Use the cursor keys to navigate through the list of options. 4. Press Enter when the desired value is displayed on the screen. Filter 1. Place the cursor before the position indicated by label E. 2. Press the Enter key. Note: The following message appears on the screen: “Please Wait...” 3. Use the Up or Down arrow keys to navigate to the AC Filter menu option. 4. Use the Right or Left arrow keys to navigate through the list of options. 5. Press Enter when the desired value is displayed on the screen. 6. Navigate to Exit menu. 7. Select Yes. The set value is displayed at position D.

Entering the system Setup menu To enter the setup menu do the following: 1. In the Startup screen, use the cursor keys on the arrowpad to navigate to the Setup parameter (Displaying “C” on the Startup screen). For more information refer to the section Navigating the Startup screen. 2. Press the Enter key to enter Setup menu. NOTE: The following message appears on the screen: Please Wait... You have now entered the Setup menu. Exiting the system setup menu To exit Setup menu select Exit and press the Enter key.

0.01 0.02[0.16] 0.32

Selection of the lower cut-off frequency of the signal transmission range: 0.01, 0.02, 0.16 or 0.32 Hz.

Auto gain

Yes [No]

When auto gain is enabled the system adjusts the gain to reduce overlapping of ECGs. In a report print, the system will specify gain selected for limb as well as chest leads separately if applied. e.g.: 10][5 mm/mV.

< (Reduce) > (Increase)

Display contrast can be reduced or increased to enhance visibility.

Yes [No]

If measurement is enabled, after the ECG recording the system prints a page with measurement results. Note: If Interpretation option is also enabled, then, after printing the page with measurement results, the Interpretation result page(s) are also printed.

Contrast

Measurement (If option enabled)

System menu descriptions The following table gives you valid options that you can choose and set for each menu item in the system setup. NOTE: Angular brackets [ ] identify default setting. Menu Item Notation

Lead

Options

Description

[AHA] IEC

Electrode designations: AHA: RA, LA, RL, LL, V1 to V6. IEC: R, L, F, N, C1 to C6.

[Stand.] (Standard) Cabr. (CABRER)

Standard lead sequence: I, II, III, aVR, aVL, aVF, V1 to V6. Cabrera lead sequence: aVL, I, mVR, II, aVF, III, V1 to V6.

• If Adaptive filter is set to Yes and AC filter is set to 50/60 Hz, the system filers AC noise in the range of 47/53 Hz, 57/63 Hz respectively. • If Adaptive filter is set to No, the system filters AC noise of 50/60 Hz only based on AC filter settings.

Cut-off frequency

Option Code

[Enter] Clear

This is used to enter/clear the following options: • ECG measurement • 3 channel report formats • Interpretation

Factory defaults

Yes [No]

Select “Yes” to restore the factory default settings.

Auto shift for 3 lead ECGs Auto Shift feature is enabled by default. Every column in the printed ECG is auto adjusted. This minimizes the overlapping of ECGs.

AC filter (line frequency)

[50] 60 Off

Off Suppression of interference: “50” for countries with 50-Hz power line. “60” for countries with 60-Hz power line.

Instructions to set parameters for the system setup: This section has instructions to set the parameters for the system setup menu. To enter the system setup menu follow the instruction given under the section Entering the System Setup Menu. NOTE: The selected value is displayed in angular brackets [ ] except for the Contrast option. Notation This is the default option that appears when you enter the system setup menu. 1. To select a value, use the right or left arrow key. 2. Press Enter key to confirm your selection. 3. Navigate to Exit menu. 4. Select Yes.

MACi Resting ECG System Guides 0459

[Yes] No

Setting Parameters for System Setup Menu

Instructions to set parameters for the Startup screen menu: Refer the figure below before following the instructions to change the default values.

A

Muscle Filter 1. Place the cursor before the position indicated by label F. 2. Press the Enter key. 3. Use the cursor keys to navigate through the list of values. 4. Press Enter when the desired value is displayed on the screen. Note: In the figure above the muscle filter is turned off, hence there is no value displayed at the position indicated by label F.

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Lead 1. 2. 3. 4. 5.

Use Up /Down cursor keys to navigate to the Lead menu option. To select a value, use the right or left arrow key. Press Enter key to confirm your selection Navigate to Exit menu. Select Yes.

AC filter For instructions to set the AC Filter value refer to Instructions to set parameters for the startup screen menu. Adaptive Filter 1. Use Up /Down cursor keys to navigate to the Adaptive Filter menu option. 2. To select a value, use the right or left arrow key. 3. Press Enter key to confirm your selection. 4. Navigate to Exit menu. 5. Select Yes. Cut-off frequency 1. Use Up /Down cursor keys to navigate to Cut-off frequency menu option. 2. To select a value, use the right or left arrow key. 3. Press Enter key to confirm your selection. 4. Navigate to Exit menu. 5. Select Yes. Auto gain 1. Use Up /Down cursor keys to navigate to Auto gain menu option. 2. To select a value, use the right or left arrow key. 3. Press Enter key to confirm your selection. 4. Navigate to Exit menu. 5. Select Yes. NOTE: Auto gain is applicable only in 3 channel mode. Contrast 1. Use Up /Down cursor keys to navigate to Contrast menu option. 2. To lessen the contrast, use the left arrow key. OR To increase the contrast, use the right arrow key. 3. Navigate to Exit menu. 4. Select Yes. Measurement (If option enabled) 1. Use Up /Down cursor keys to navigate to Measurement menu option. 2. To select a value, use the right or left arrow key. 3. Press Enter key to confirm your selection. 4. Navigate to Exit menu. 5. Select Yes. Option Code 1. Use Up /Down cursor keys to navigate to Option Code menu. 2. Select Enter Option and press Enter key. 3. Enter the option code. 4. Navigate to Exit menu. 5. Select Yes. NOTE: This system has optional features for enabling measurement, 3 channel report formats and interpretation. Contact GE Healthcare for more information. Factory defaults 1. Use Up /Down cursor keys to navigate to Factory defaults menu option. 2. To select a value, use the right or left arrow key. 3. Press Enter key to confirm your selection. 4. Navigate to Exit menu. 5. Select Yes.

Page 4 of 8 Revision C

MAC™ i Resting ECG System-Operator Guide ©2009, 2011, General Electric Company. All Rights Reserved

The MACi Resting ECG System Operator Guide provides instructions for using the system to record ECG. Before recording an ECG, you must prepare the patient and set up the electrode and lead wire connections. A. Preparing the patient’s skin. Prep the skin to help ensure an interference-free ECG. To prep the skin: 1. Shave hair from the area and de-grease each electrode site with alcohol. 2. Use an abrasive pad or skin prep cream to remove the epidermal skin layer at each site. B. Applying electrodes Apply electrode cream or gel to the electrode sites and attach the suction bulbs at each site. If using electrode paper, moisten it with water and apply it to the patient’s skin at the application points. Apply a small amount of electrode cream or gel to the metal electrode of each clamp. Apply the clamp electrodes to the limbs as indicated in the Electrode Placement table. C. Connecting standard ECG leads Four limb and six chest electrodes must be applied to the patient for acquisition of the standard leads I, II, III, aVR, aVL, aVF, and V1 to V6. Connect the six bulb electrodes to the chest lead wires and the four clamp electrodes to the limb lead wires.

Operating modes

ELECTRODE PLACEMENT The following table explains the location of each placement and identifies the labels for AHA or IEC notations.

The MACi system has two operating modes for recording ECGs, ECG mode and Rhythm mode. Select the mode you want to use, adjust the settings, and follow the operating instructions.

1. ECG Mode

AHA Label

IEC Label

Electrode Placement

V1 brown/ red

C1 white/ red

Fourth intercostal space at the right sternal border.

V2 brown/ yellow

C2 white/ yellow

Fourth intercostal space at the left sternal border.

V3 brown/ green

C3 white/ green

Midway between C2/V2 and C4/V4.

V4 brown/ blue

C4 white/ brown

Mid-clavicular line in the fifth intercostal space.

V5 brown/ orange

C5 white/ black

Anterior auxiliary line on the same horizontal level as C4/V4.

V6 brown/ violet

C6 white/ violet

Mid-auxiliary line on the same horizontal level as C4/V4 and C5/V5.

LA black

L yellow

Above left wrist (alternate placement: left deltoid).

LL red

F green

Above left ankle (alternate placement: upper leg close to torso).

RL green

N black

Above right ankle (alternate placement: upper leg close to torso).

RA white

R red

Above right wrist (alternate placement: right deltoid).

The default operating mode for the system is ECG mode. When initiated in ECG mode, the system simultaneously acquires 12 leads of ECG for a period of 10 seconds and then recording proceeds automatically. The system measures and analyzes the ECG and records the results on a report (If the option is enabled). You can choose between simultaneous and sequential report formats: You may choose standard or CABRERA lead sequence recordings. The factory default records all 12 leads simultaneously on 12 sheets, each representing a period of 3 seconds. NOTE 1: The system does not support lead fail indication for the N/RL electrode. If the ECG is extremely noisy, the N/RL electrode may not be properly connected. Check and reconnect. NOTE 2: During selection of Startup screen parameters (while the cursor is blinking) printing cannot be initiated.

Report formats This section describes the report formats of ECGs printed in the ECG mode for Standard and Cabrera leads. Example of Sim 1 report format:

Issue Waveform gets clipped in a 3-channel mode

Solution Solution One: 1. Enable Auto gain under configuration menu. 2. Re-acquire ECG. Solution Two: 1. Set the report format to single lead mode (Sim 1 or Seq 1). 2. Re-acquire the ECG.

NOTE: The length and scope of the reports can vary depending on the operating mode and selected lead and report format.

2. Rhythm Mode In Rhythm mode, the system simultaneously records 1 (default) lead of ECG in real-time. NOTE: If you change the paper speed, gain, lead or filter settings during a recording, the system briefly stops, advances the paper a few millimeters and then resumes recording. For ECG and Rhythm modes, the leads that can be selected based on the lead sequence chosen is as given below: Lead Sequence

D. Arranging the patient cable (as shown) The table below shows four types of report formats that the system supports,

Type of Report Format

Description

(Sim 1) Simultaneous format with one channel print.

Sim 1 prints 1 lead x 3 second data in 12 pages. Data is acquired simultaneously for 10 seconds.

(Seq1) Sequential format with 1 channel print.

Seq 1 prints 1 lead x 2.5 second data in 12 pages. Data is acquired simultaneously for 10 seconds but presented sequentially. (First 3 columns will show the first 2.5 sec data, next 3 columns will show data from 2.5 to 5 sec, next 3 from 5 to 7.5 sec and final 3 from 7.5 to 10 sec data).

To chest leads

Correct E. Recording an ECG in all operating modes 1. Turn on the system. 2. Use the cursor keys to select either ECG or Rhythm operating mode. 3. Wait for the patient to lie motionless. 4. Wait for a stabilized heart rate to appear on the default screen. 5. Press Start/Stop or ECG key to initiate ECG acquisition and recording. NOTE: For details on changing the settings, see the MAC i Installation and Setup Guide.

(Sim3 (Optional)) Simultaneous format with 3 channel print.

Sim 3 prints 3 leads x 3 second data in 4 pages. Data is acquired simultaneously for 10 seconds.

(Seq3 (Optional)) Sequential format with 3 channel print.

Seq 3 prints 3 leads x 2.5 second data in 4 pages. Data is acquired simultaneously for 10 seconds but presented sequentially. (First column will show the first 2.5 sec data, next column will show data from 2.5 to 5 sec, next column from 5 to 7.5 sec and final column from 7.5 to 10 sec data).

MACi Resting ECG System Guides 0459

The table below gives alternative ways to print ECG waveforms when waveforms get clipped because of high amplitude input signal in 3 channel mode.

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Leads Available

Standard

I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

Cabrera

aVL, I, mVR, II, aVF, III, V1, V2, V3, V4, V5, V6

Measurement Results Following the ECG recording, the system prints one page of measurement results using the 12SL algorithm if the Measurement option is enabled. These measurement results contain: • Vent Rate • QRS duration • QT/QTc • PR interval • P duration • RR interval • P-R-T axes

Interpretation Results Following the Measurements page, the system prints one page of interpretation results using the 12SL algorithm if the Interpretation option is enabled and the Measurement system setting is enabled. Since it is not possible to enter a patient’s age, the data is interpreted as an adult ECG. For a detailed description of the ECG measurement and interpretation program, refer to the 12SL™ Physician’s Guide.“

Page 5 of 8 Revision C

MAC™ i Resting ECG System-Maintenance Guide © 2009, 2011, General Electric Company. All Rights Reserved

The MAC™ i Resting ECG Analysis System Maintenance Guide provides maintenance and troubleshooting details for the system.

STERILIZING ELECTRODES The only approved sterilization method is gas sterilization. Sterilize with ethylene oxide gas (EtO) at a maximum temperature of 50° C/122° F. After EtO sterilization, follow the manufacturer’s recommendations for required aeration. NOTE: Frequent sterilization reduces the useful life of cables and lead wires.

Printer maintenance

Recommended Maintenance Cleaning and disinfecting exterior surfaces Clean and disinfect exterior surfaces monthly, or more often as needed. To clean exterior surfaces: 1. Use a clean, soft cloth and an agent or disinfectant that contains alcohol and is commonly used in hospitals. NOTE: Do not use disinfectants with a phenol base or peroxide compounds. 2. Wring excess water/solution from the cloth. Do NOT drip water or any liquid on the system and avoid open vents, plugs, or connectors. 3. Dry surfaces with a clean cloth or paper towel.

Patient cables and lead wires maintenance Clean and disinfect cables and lead wires as specified and depending on activity.

CLEANING AND DISINFECTING PATIENT CABLES AND LEAD WIRES 1. Remove cables and lead wires from the system before cleaning. 2. Avoid pulling long wires from connector ends. Metal connections can be pulled away from the connectors. 3. To clean cables and lead wires, wipe using a lightly moistened cloth with mild soap and water. 4. Wipe off excess moisture and allow to air dry. CAUTION: EQUIPMENT DAMAGE, SIGNAL DETERIORATION-Any contact of disinfectant solutions with metal parts may cause corrosion. Avoid using disinfectant solution around the metal parts. 5. To disinfect cables, lead wires, wipe exterior with a soft, lintfree cloth. Use the following solution as recommended in the APIC Guidelines for Selection and Use of Disinfectants (1996): •

Sodium hypochlorite (5.2% household bleach) minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution. • Any sodium hypochlorite wipe product that meets the above guidelines can be used. NOTE: Wring excess disinfectant from the cloth before using. 6. Wipe off cleaning solutions with a clean, lightly-moistened cloth. 7. Dry thoroughly with a dry, lint-free cloth and let air dry for at least 30 minutes. Do not to let liquid pool around the connection pins. NOTE: Drying times may vary based on environmental conditions. Do NOT use excessive drying techniques, such as oven, forced heat or sun drying. CAUTION: Never autoclave ECG cables and other accessories or dip it in CIDEX solution.

CLEANING AND DISINFECTING ELECTRODES Clean reusable electrodes immediately after use on a patient. 1. Use warm water and a small brush to remove cream or gel. Do not use pointed or sharp objects for cleaning. 2. Disinfect the electrodes with alcohol-free disinfectant. Ensure that connectors and sockets do not get wet.

CLEANING THE PRINTHEAD If the printer is not functioning properly, you may need to clean dust and foreign particles from the printhead. To clean the printhead: 1. Open the printer door. 2. Gently wipe off the heating element part of the surface with cotton swabs dipped in ethyl alcohol (Wring the cotton before cleaning). 3. Close the printer door when it is completely dry. NOTE: Do not use products that can harm the heating element, such as sandpaper. Avoid unnecessary force when handling the printhead.

Battery Maintenance The MACi battery has a shelf life of six months. Recharge the battery once every six months when stored for a long period of time. The system switches off when the battery is completely discharged. Charge battery regularly to maximize battery life. To operate the system do the following: • Connect the system to a AC power supply. • Switch on the system. The default screen is displayed.

•

Do not coil lead wires or cables tightly around the system.

STORING THERMAL PAPER NOTE: To ensure maximum image life, store thermal paper separately in manila folders or polyester/polymide protectors. To avoid deterioration or fading, follow these precautions: 1. Store in cool, dark, and dry locations. Temperature must be below 86°F (30°C). Relative humidity must be less than (<) 65%. 2. Avoid exposure to bright light or ultraviolet sources such as sunlight, fluorescent, and similar lighting which causes yellowing and fading. 3. Do NOT store thermal papers with any of the following: • Carbon and carbonless forms. • Non-thermal papers or any products containing tributyl phosphate, dibutyl phthalate, or other organic solvents. Many medical and industrial writer papers contain these chemicals. • Document protectors, envelopes, and sheet separators containing polyvinyl chloride or other vinyl chlorides. 4. Avoid contact with: cleaning fluids and solvents such as alcohols, ketones, esters, ether, etc. 5. Do NOT use: mounting forms, pressure-sensitive tapes, or labels containing solvent-based adhesives. REPLACING PAPER The MACi system uses roll paper. NOTE: Use only original GE writer paper. This paper has a special coating that prevents contamination and debris collection on the printhead, and electrostatic buildup. Using other paper may result in recordings of poor quality. The printhead may wear out prematurely, and use of other paper may void the warranty. CAUTION: RISK OF SKIN BURNS - The printhead gets hot when recording. Do not to touch the thermal printhead when inserting the paper.

To print an ECG after low battery shutdown do the following. • Connect the system to an AC power supply. • Recharge the battery for 20 minutes. • Disconnect the AC power supply. • Acquire ECG.

REPLACING BATTERY Instructions to replace battery Follow the instructions given below to replace battery:

To print an ECG after the battery is fully discharged do the following. • Connect the system to an AC power supply. • Recharge the battery for 90 minutes. NOTE: The system will not acquire or print ECG if it is connected to the AC power supply.

Visual Inspection Inspections include the following checks: • Visual inspection of equipment and accessories for signs of mechanical damage that may impair the systems functions. • Visual inspection of the system labeling for legibility.

1. Gently turn the unit over and remove the cover of the battery compartment by pulling it along the direction of the arrow etched on the cover of the battery compartment. 2. Remove the old battery from the compartment. 3. Insert the new battery as shown in the figure. 4. Replace the cover of the battery compartment.

Calibration Check Regular calibration check of the system is recommended once a year. To check calibration of the system, follow the steps given below: 1. Switch on the system. 2. Connect the patient cable to the system. 3. Take a rhythm printout in default settings for all leads. NOTE: Start Rhythm recording, wait for 2 to 3 seconds and then stop recording for every lead. 4. Ensure that the calibration pulse for all leads is 5mm ±5% in width and 10mm ± 5% in height.

Error messages Message Paper Error

GE Healthcare does not recommend any preventive maintenance for this system. However preventive maintenance may be performed by the user. Refer service manual for details on how to perform preventive maintenance. If further technical assistance is required, contact the nearest GE Healthcare Service Center. STORING CABLES AND LEAD WIRES • Store in a dry well-ventilated area. • Vertically hang cables and lead wires.

Door Open

2047427-001

• Battery not present. • Battery not functioning properly.

Check for battery. Check that contacts are clean. Notify service to check and replace the battery.Press the start/stop key to clear message.

Printer too hot

The printer mechanism has heated up due to heavy use.

Turn off system and power on after 3 to 4 minutes. If problem recurs with normal use, notify service.

Writer Error

Printer door opened and closed while printing.

Press the Start/Stop key to clear the message.

Remove AC Mains

Message appears when AC mains is connected and acquiring is attempted.

Disconnect AC mains and press Start/Stop key to resume normal operation.

Disposal of the product The product described in this guide must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. WARNING: EXPLOSION HAZARD - Batteries may explode in fires. Do not dispose of the battery by fire or burning. Follow local environmental guidelines concerning disposal and recycling.

Troubleshooting Tips These errors may occur while operating this system. If you perform the recommended actions and the condition remains, contact GE Healthcare Service for assistance. Problem

Cause

Solution

Periodic superimposition of AC line interface (50/60Hz). (See Figure 1)

Interference from the power line.

Ground bed, verify position of the lead wires, switch on the AC filter.

Superimposition of irregular interference signals.

Muscle artifact caused by patient movements, hiccup, coughing.

The patient should be resting comfortably. (place cushions under arms and knees). Enable muscle filter (20/40 Hz), if necessary.

The green LED does not light up, although the unit is connected to the power line.

Defective AC/DC power adapter.

Notify service to check AC/DC power adapter.

Recorder does not write over the entire paper.

Paper compartment not properly closed.

Printer door must lock into place on both sides. Perform the roller test.

Solution

The system is out of paper.

Check paper supply.

Paper jam

Remove jammed paper. Press the Start/Stop key to the clear message.

Printer door not closed properly.

Close printer door correctly.

Preventive Maintenance

MACi Resting ECG System Guides 0459

Cause

Battery Error

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MAC™ i Resting ECG System-Maintenance Guide ©2009, 2011, General Electric Company. All Rights Reserved

Improper printing

Lead/Cable disconnect

Adhesion of dust and foreign materials to paper can deteriorate the life of the printer head and plate.

Clean the printhead as indicated in this guide.

Leads not properly connected to the patient.

The lead which is not properly connected is indicated on the display. Ensure connectivity from the electrodes to the leads.

Consumables Part Number

Description

21708318

Electrode cream, 250-ml refill bottle

Writer Paper Part Number 2044812-001

Description Roll paper MACi 58MM W (10 Roll Pack)

Figure 1

Ordering information The supplies and accessories that can be ordered are listed below. NOTE: To order supplies and accessories contact GE Service or a GE approved vendor.

Accessory Kits Part Number

Description

2047162-001

IEC Value Starter kit (includes one ECG cable with lead wires, four clamp electrodes, six bulb electrodes, one roll paper & gel (electrode cream).

2047162-002

AHA Value Starter kit (includes one ECG cable with lead wires, four clamp electrodes, six bulb electrodes, one roll paper & gel (electrode cream).

Patient Cables Part Number

Description

2029890-001

Patient cable, 10 leads, IEC

2029893-001

Patient cable, 10 leads, AHA

Electrodes Part Number

Description

2029891-001

Clamp electrode for limb leads, IEC, set of 4, with labels

2029894-001

Clamp electrode for limb leads, AHA, set of 4, with labels

2029892-001

Bulb electrode for chest leads, set of 6, with labels

MACi Resting ECG System Guides 0459

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MAC™ i Resting ECG System-Electromagnetic Compatibility © 2009, 2011, General Electric Company. All Rights Reserved

The MAC™ i Resting ECG Analysis System Electromagnetic Compatibility Guide provides electromagnetic compatibility details for the system. Changes or modification to the MAC i system not expressly approved by GE Healthcare could cause EMC issues. This system is designed and tested to comply with applicable regulation regarding EMC and needs to be installed and used according to the EMC information stated as follows.

Descriptions

RADIO FREQUENCY INTERFERENCE

Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. Do not use RF emitting equipment near the device. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in that configuration. The equipment or system should not be used adjacent to, or stacked with, other equipment.

Guidance and Manufacturer’s Declaration-Electromagnetic Emissions

Emissions test RF emissions EN 55011

Compliance Group 1

RF emissions EN 55011

Class A

Harmonic Emissions EN 61000-3-2

Class A

Voltage fluctuations/Flicker emissions EN 61000-3-3

Complies

Immunity test

Immunity test

Electrostatic Discharge (ESD) IEC 61000-4-2

Cautions

EQUIPMENT INTERFERENCE

Guidance and Manufacturer’s Declaration-Electromagnetic Immunity

The MAC i is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

± 2 kV for power supply lines

Mains power should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV line(s) to line(s)

Mains power should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency(50/60 Hz) magnetic field IEC 61000-4-8

<5% Ut (>95% dip in Ut) for 0.5 cycles 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec

Mains power should be that of a typical commercial or hospital environment. If the user of the MAC i requires continued operation during power mains interruptions, it is recommended that the MAC i be powered from an uninterruptable power supply or a battery.

3 A/m

Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

Recommended Separation Distance Electromagnetic environment-guidance

Portable and mobile RF communications equipment should be used no closer to any part of the MAC i, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Electromagnetic environment-guidance

Electrical fast Transient/ burst IEC 61000-4-4

Electromagnetic environment-guidance The MAC i uses RF energy for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

EN60601 test level/ Compliance level

EN60601 test level/ Compliance level

Conducted RF EN 61000-4-6

Radiated RF EN61000-4-3

3 Vrms 150 KHz to 80 MHz

3V/m 80 MHz to 2.5 GHz

Recommended separation distance

d = 12 P

150 kHz to 80 MHz d = 1.17 x

P

80 MHz to 800 MHz d = 1.17 x

P

800 MHz to 2,5 GHz d = 2.34 x

0.01

0.117

0.117

0.234

0.1

0.370

0.370

0.740

1

1.170

1.170

2.340

10

3.700

3.700

7.400

100

11.700

11.700

23.400

800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by reflection from structures, objects and people.

Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

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Separation distance according to frequency of transmitter m

d = 1.2 P d = 2.3 P

MACi Resting ECG System Guides

Rated maximum output power of transmitter in watts W

80 MHz to 800 MHz

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MAC i is used exceeds the applicable RF compliance level above, the MAC i should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MAC i.

0459

The following table provides the recommended separation distances (in meters) between portable and mobile RF communication equipment and the MAC i system. The MAC i system is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled. The customer or the user of the MAC i system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MAC i system as recommended below, according to the maximum output power of the communications equipment.

P

For transmitters rated at a maximum output power not listed above, the recommended separation distance [d] in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the higher frequency range applies Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: + 1 414 355 5000 1 800 558 7044 (US Only) Fax: + 1 414 355 3790 www.gehealthcare.com China Address GE Medical Systems Information Technologies Asia GE (China) Co., Ltd. Shanghai GE (China) Hitech Park, No 1 Huatuo Road, Zhangjiang Hi-tech Park Pudong Shanghai, P.R. of China 201203 Tel: + 86- 21-3877-4000 Fax: + 86 21 5208 2008

GE Medical Systems Information Technologies GmbH Munzinger Straße 3-5 D-79111 Freiburg Germany Tel: + 49 761 45 43 - 0 Fax: + 49 761 45 43 - 233 India Address: Wipro GE Healthcare Pvt Ltd. No. 4, Kadugodi Industrial Area Bangalore - 560067 Karnataka, India T 91 80 2845 2923/25/26 F 91 80 28452924 www.wiproge.com

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