EPS320B Quick Installation Guide Ver 1.8

EPS320B Cardiac Stimulator

Quick Installation Guide for 4 channel Touch Screen Stimulator

1 Unpack and verify all components are present as per Packing List. a. MP3113B-X (Touch screen) b. MP3102BT-X-X (SGU/Bona PC Carton and cable accessories)

Stimulus Generator Unit (SGU) MP3008

Touch screen MP3113-GE (Part of MPEPS320FULL-A)

SGU Power Supply MP3074

Stimulus Multiplexor BOX MP3086 Accessories Box MP3055

Patient Box MP30141

Bona PC MP3093 Keyboard MP3016

Serial Boost MP3033A Installation Kit MP3063

Stimulus Extension MP3070 BNC to Phono MP3109

Signal cable MP3034

Universal Transformer MP3107 SM-Box Extension cable MP3090

MET Laboratories Inc.- Certified E212294

Figure 1 MET Laboratories Inc. approved components shown on the left.

Note 1 : Optional part, not a component of MP320BFULL.

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GE-EPS320B Combo Quick Install Guide

NRTL Listed equipment approved by MET Registration Number E212294 Item Part No Description 1 MP3008 Stimulus Generator Unit ( SGU ) 2 MP3074 Power Supply GTM21089-1815-T2 ( PSU1 ) 3 MP3109 BNC to Phone Signal Cable 4 MP3033A Serial Boost RS232 Cable ( 2m ) 5 MP3034 Signal cable with Phone Plugs 6 MP3063 Installation Kit Incl. (i) 4X Fuses T1.25A 250V, (ii) LED Tester MP3058 7 MP3086 Stimulus Multiplexer BOX 8 MP3070 Stimulus Extension cable Optional approved parts 9 MP3014 Stimulus Connection Box 10 MP3084 RS232 Extension Cable 25 Meters

Table 1 NRTL approved equipment

2 You will be Interconnect the five main components according to the below overview and

subsequent detailed instruction steps 2 – 4. Ensure all components have adequate ventilation.

Figure 2 Overview of Stimulator Connections

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EPS320B Cardiac Stimulator

Lay out and connect Stimulus cabling, (under ground if required) between EPS320 Stimulus Generator Unit (SGU) and EP Amplifier (LS Pro and CardioLab recorders shown): LS Pro Amplifier

CardioLab Amplifier

LS Pro Amplifier

CardioLab IEB 1

Note: for CardioLab II, ECG output is found on the IEB Labelled “Anlg Out - 1”.

Warning: To prevent patient micro-electrocution through capacitively coupled leakage currents, MP3070 and MP3126 cable installation must be (i) appropriately insulated and separated from any nearby mains wiring to prevent injection of mains voltage through broken insulation, (ii) must not be installed next to mains voltage–energised cables and (iii) should not be installed within grounded conduits. Installation should be acceptance tested by biomedical engineer for Patient Applied Part, Class CF device.

Note that when longer (>15m) length of Extension Stim Cable is required, it is preferable to place the SGU in the operating room on top of the Amplifier under the patient table and use a long 80’/25m serial cable MP3084-25 to interconnect PC with SGU. This will reduce noise and ground leakage currents in the whole installation.

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GE-EPS320B Combo Quick Install Guide

Connect all power supplies to Isolation transformer and interconnect SGU and PC serial ports

4 with MP3033A.

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EPS320B Cardiac Stimulator

5 Interconnect Eps320b Computer, LCD Display And SGU:

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GE-EPS320B Combo Quick Install Guide

6 Now Set up the computer: a. Switch on (i) Isolation transformer, (ii) Bona PC (push front button once), (iii) LCD Display (on the side) and (iv) SGU at the rear. Allow system to boot up. b. When prompted respond that you are the distributor (to avoid having the License agreement shown to you) c. If you have an EU version, you will be offered a menu to chose an interface language. d. When prompted to calibrate screen, touch screen in the places indicated by crosses from the seated position and the same eye level as the customer will use, using the stylus.

e. You will now see the Mains Stimulator Screen as below: f. The stimulator software will already be configured for the hardware setup you purchased – touch screen, four channels and one external ECG.

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EPS320B Cardiac Stimulator

Verify System (use checklist on last page): a. Verify Isolated Mains. Visually verify that all EPS320B components – PC, SGU, LCD Screen, are connected to a Medical Grade Mains Isolation Transformer e.g. MP3107. b. Clean launch. Verify that SGU and Software launch without errors. c.

Test Pacing channels. Insert Stimulus Test LED, MP3058 (from the Installation Kit in the Accessories Box) ) into the EP Recording Equipment’s bedside catheter input modules (CIM’s) - Block A. Configure the EP Recording Equipment to stimulate those outputs from the Chan 1 Atrial stimulation channel. Set current to 25mA and commence pacing into the Atrium. The Stimulus Test LED should light with pacing (Yellow light indicates that the stimulus pulse is positive at the red connector and negative at the black one while Red light indicates the opposite or wrong polarity). Repeat pacing test for all four channels, using other 3 CIM Blocks. Similarly verify that Emergency Fixed Rate Pacing (red output socket) stimulates into Ventricle / Chan 2.

d. Verify ECG sensing. Connect ECG simulator to EP recorder surface leads, select one channel to sense from and verify that EPS320B Stimulator displays the ECG on the screen (if you don’t have a simulator, create some noise on channel by touching the electrode). e. Safety Acceptance. Finally, organise Biomedical engineering to perform acceptance test the entire installed system according to the health facilities’ procedure’s. f.

Troubleshooting. If there are problems, refer to the troubleshooting section below, in the Installation Manual, the User Instruction Manual or the Micropace Connect iPad Application.

g. Make a record. Make a record of the verified installation and sign and date according to your company’s quality system and file as required.

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GE-EPS320B Combo Quick Install Guide

8 Train Customer a. Customize Stimulator settings. Sit down with the responsible customer – chief technician or physician and set up various defaults for the Stimulator – default S1 values in protocols, minimum S1 and Sx values in Configuration menu. Save defaults into one or more of the Setups. b. Demonstrate User Instruction Manual. Inform the electrophysiologist and technician of the safety features of the stimulator and direct them to the relevant sections in the User Instruction Manual where safety warnings are listed. c.

Demonstrate Help feature, (hotkey ‘h’) wherever they are in the program, including diagrams. Explain Safety Diagram as an aid to safety items below. Help/ 3.Diagrams/ 6.Safety Guide is a useful diagram for this.

d. Demonstrate F12 Emergency Pacing key. While Stimulator is in normal PC control mode and in any protocol, press F12 / Red First Aid cross symbol on keyboard to demonstrate Emergency Pace protocol whereby both channels are immediately paced. e. Demonstrate Manual Backup Pacing Mode - Demonstrate this safety mode (in cases of PC failure) by pressing the 'BACKUP ENABLE' button on the Stimulator) (or disconnecting Serial Cable MP3033A. Press 'PACE ON/OFF' button to pace. Adjust ‘Interval’ with up/down arrow buttons. Pacing is always into both channels. Remind user that if Ep Recorder is not working, they MUST plug the pacing leads into the Bypass Stim Outputs on the recorder's catheter input modules (CIM’s). Hit [Enter] on the computer to re-enter PC Control mode. f.

Demonstrate Fixed Rate Emergency Pacing Mode. Instruct the User that should the SGU itself fail, they can use this feature. Connect Stimulus Test LED, MP3058 to Stimulator Output on the Ventricle / Chan 2 output and on the SGU front panel, remove the Stimulus Connection Box’s MP3014 green connector from the SGU's green Pace Output socket and insert it into it's red Emergency Fixed Pace Output socket. The self-contained emergency circuit will commence pacing at 100 pulses per minute, 5mA and 2ms width (it detects presence of load resistance on the output and commences pacing automatically).

9 Make record. Make a record of the verified installation, date and sign and lodge record according to your company’s quality system requirements. Installation is now finished.

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EPS320B Cardiac Stimulator

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Troubleshooting 1. System problems #

Problem

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No External ECG on EPS320B screen, patient or simulator is connected.

Explanation No external ECG signal connected to SGU ECG1 Input, Or SGU Fault

Suggested action 1. Select Alt-I, i.e. sense from catheter tip of paced electrode – this should always show an ECG if adequately placed in the heart. 2. If using External ECG inputs, verify connection and settings on EP EP Recording Equipment 3. Verify that ECG is indeed connected into the ECG inputs, and not the Sync Output on the rear of the SGU.

2. Stimulus Generator Error Message on Front Display. Error Message

Error Name

Explanation

Suggested action

b,A,t,t ,E,r,r

Battery Error

Internal Backup Battery is depleted due to operation or prolonged storage without external power connected. Stimulus Generator Unit(SGU) can function on external power only.

Reconnect external power and press Backup Enable button. SGU may be used while connected to external power. Allow unit to charge for 6 hours. If error persists after recharge then 12V Battery is faulty.

b,A,t,t , ,L,O

Battery Low

Backup Battery charge is low due to operation or prolonged storage without external power connected. Stimulus Generator Unit(SGU) will function normally, but requires recharging.

E,b,a,t,E,r,r

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Emerg. Batt Error

Emergency Battery self test failed indicating 9V LiMn battery is depleted. This battery has shelf life of 10 years, so this error indicates either excessive use of Emergency Pacing or early depletion of battery due to faulty battery or faulty circuit.

Reconnect external power and press Backup Enable button. SGU may be used while connected to external power. Allow unit to charge for 6 hours. If error persists after recharge then 12V Battery is faulty. Contact the Distributor, Micropace or your biomedical engineering department to have Emergency Pace Battery replaced.

GE-EPS320B Combo Quick Install Guide

Ver 1.2, 1.6.06 , M.Cejnar

Micropace Installation Checklist

The following checklist is to be performed after installation EPS320B and before fist ‘live’ EP case. Any exceptions / failures must be signed off by Clinical specialist or engineer prior to use on patients. Item

Test Method

Expected

1.Mains Isolation

Visually verify that all EPS320B components – PC, SGU, LCD Screen, are connected to a Medical Grade Mains Isolation Transformer e.g. MP3107, not wall socket.

All components plugged into Isolation Transformer.

2.SGU POST

Power on SGU and observe all LED’s during POST

All LED’s light momentarily (except Emergency Fixed Rate Pace) and no errors appear on SGU display.

3.Software Launches OK

Observe EPS320 Software launches without error messages.

SGU Main screen appears, no error messages

4.Stimulation path & Polarity OK.

Connect EPS320B to EP Recorder, both configured for Ventricle/Chan 2 to stimulate at 20mA 10ms S1: 300ms; Insert Yellow/Red Test LED (MP3058) into breakout box where stimulus expected red to +ve. Start pacing and verify yellow LED lights with each pulse. If red LED lights then polarity is incorrect.

Yellow LED flashes with each stimulus.

5.Emergency Fixed Rate Pacing OK

With a Test LED across the Ventricle/Chan2 output s in 4. above, change over stimulus cable connection to the SGU from Pace Output green socket) to Emergency Fixed Rate Pacing Output (red socket). Observe pacing. Restore stimulus cable to green ‘Stimulus Output’ connector.

Pacing sound is emitted and yellow LED lights at approx. 100 ± 20% ppm. Test LED pulses light. ‘Battery’ indicator lights after about 4s.

6.ECG Visible

Connect ECG simulator to one channel on the EP Recorder, select it for ECG sensing and verify that EPS320B displays ECG on its screen. If no ECG simulator available, connect one pin of Test LED and get someone to touch the other pin to create an unbalanced noise source.

ECG / noise is seen on EPS320B screen.

7. Biomed Engineering approval

Health facility’s Biomedical Engineering Dept. is generally required to test and accept the installed system for electrical safety; ensure that this has been done.

Biomed Engineering acceptance verified.

Observed

P/F

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