RADIANALYZERX Service Manual Rev 02 Nov 2005

WARRANTY AND LIABILITY Radi Medical Systems AB excludes all warranties, whether express or implied by operation or otherwise, including but not limited to, any implied warranties of merchantability or fitness, because handling, storage and cleaning, by the user, as well as factors relating to the diagnosis, treatment, surgical procedure and other matters beyond the control of Radi Medical Systems AB, directly affect this system and the results obtained from its use. Radi Medical Systems AB shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from use of this system. Radi Medical Systems AB neither assumes nor authorizes any other person to assume for it any other or additional liability or responsibility in connection with this system. This product is intended for use by a physician. Prior to use, it is important to read the instructions for use, warnings and potential complications associated with the use of this system. Only high quality material and expert workmanship are utilized in the process of manufacturing all Radi Medical Systems (Radi) products. Defects in material or workmanship, excluding consumables, will be repaired or replaced at the sole discretion of Radi Medical Systems for a period of one year from the date of shipment. Abuse or neglect are not covered under the terms of this warranty. TRADEMARKS RadiAnalyzer, RadiView and PressureWire are registered trademarks of Radi Medical Systems AB.

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CONTENTS Warranty and liability 1. System introduction 1.1 Optional hardware 2. System description 2.1 User interface 2.2 Connectors main unit 2.3 Connectors Signal Modules 2.4 Classifications 3. Abbreviations 4. Installing RadiAnalyzer®Xpress 4.1 Mounting the unit 4.2 Connecting the power supply 4.3 Connecting to cathlab monitoring system 4.4 RadiAnalyzer® Printer Kit installation 4.5 RadiView® setup 5. Maintenance Instructions 5.1 Cleaning RadiAnalyzer®Xpress 5.2 Leakage current measurement 5.3 Earth resistance measurement 5.4 Testing the AO IN 5.5 Testing the PW IN 5.6 Testing the CFR/Temperature Option 5.7. Testing the AO OUT and associated monitor channel 5.8 Testing the PW OUT and associated monitor channel 5.9 Testing the AO Adapter cable 5.10 Testing the PW or AO monitor cable 5.11 Testing RadiAnalyzer®Xpress remote control 5.12 Testing RadiAnalyzer® Printer 5.13 Testing RadiView® Software accessories 6. Upgrade of RadiAnalyzer®Xpress software 7. Remote Control 8. Troubleshooting 9. RadiAnalyzer® Test Unit (RTU) 10. RadiAnalyzer®Xpress leakage 11. Upgrade protocol 12. Scheduled maintenance 13. Service report RadiAnalyzer®Xpress

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1. SYSTEM INTRODUCTION The RadiAnalyzer®Xpress system consists of the following parts (see Fig. 1): • RadiAnalyzer®Xpress main unit. – PressureWire IN, input for PressureWire® sensor. – AO IN, input for catheter pressure transducer. – PressureWire OUT, output for analog output to the existing patient monitor. – AO OUT, output for analog output to the existing patient monitor. • RadiAnalyzer®Xpress remote control. • Adapter cable: The cable adapting transducers with interface cable for the existing monitor so that they can be connected to RadiAnalyzer®Xpress. • Monitor cables: The cables connecting RadiAnalyzer®Xpress analog output to the existing monitor.

RadiAnalyzer®Xpress main unit

PressureWire®

Monitor cables

AO adapter cable

Remote control

Figure 1. RadiAnalyzer®Xpress with connected cables

1.1

Optional hardware

The following options can be used in conjunction with RadiAnalyzer®Xpress:

1.1.1

RadiAnalyzer® Printer Kit

Contains the following parts (see Fig. 2). • Printer with AC-adapter • Optical modem • Fiber optic cable RADIANALYZER®XPRESS – SERVICE MANUAL

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Fiber optic cable

Printer Optical modem

AC adapter

Figure 2. RadiAnalyzer®Xpress with connected printer kit

1.1.2

RadiView® Software package

Contains the following parts (see Fig. 3). • Software application to be installed on an external PC • Optical modem and power adapter • RS 232 cable • Fiber optic cable Fiber optic cable

External PC

Optical modem

RS232 cable

Modem power adapter

Figure 3. RadiAnalyzer®Xpress with connected RadiView® Software kit

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RADIANALYZER®XPRESS – SERVICE MANUAL

2. SYSTEM DESCRIPTION The RadiAnalyzer®Xpress main unit includes a graphic display that presents realtime pressure curves as well as mean values of pressures. The graphic display is also used in all interaction with user through the software based menu system. The system is operated via the remote control or keyboard on the display. On the rear side of the main unit there is 1 optically insulated serial port for communication with other equipment. There are two Cardiac Floating (CF) sections with a total of 4 insulated applied parts with signal I/O ports in the main unit (See Fig. 4): • PressureWire® IN for connecting PressureWire® Sensor. • AO IN for connecting the external pressure transducer. • PressureWire® OUT for connecting an analog distal pressure signal to the present monitor. • AO OUT for connecting an analog aortic pressure signal to the present monitor. Remote Control

Cardiac Floating Main Board PCB Input Module PW Sensor Input Interface

Input Control AD

Monitor AO

Main Control Module

IR Control

DSP

2x Compact Flash

PC104 Board

DSP

EPT Sensor

Monitor PW

Serial Bus

Monitor Inferface Module Output Interface

Display IDE-bus

Backlight

Output Control DA Serial Bus

Power Control

Serial Key or Ethernet Control

Keypad

Cardiac Floating

External PSU Board

Figure 4. System block diagram of RadiAnalyzer®Xpress including Cardiac Floating sections

The system software can be updated using an upgrade card inserted into the upgrade (DATA) slot located under the compact flash slide lid on the back side of the main unit. RADIANALYZER®XPRESS – SERVICE MANUAL

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RadiAnalyzer®Xpress can be connected using a fiber-optic cable and modem, to RadiAnalyzer® Printer placed outside the patient environment making it possible to get printouts of recordings. RadiView® is software for transfer, review and editing of RadiAnalyzer®Xpress recordings in PC environment. An external PC located outside the patient environment can be connected to RadiAnalyzer®Xpress using a fiber-optic cable and modem.

2.1

User interface

This is a summary of the user interface, for additional information see RadiAnalyzer®Xpress Instructions For Use.

2.1.1

Graphic display

The MAIN screen is divided into six areas as shown in Fig. 5. The software structure and menus are described in RadiAnalyzer®Xpress Instructions For Use chapter Menus. 3

2

4

1

5

6

Figure 5. RadiAnalyzer®Xpress MAIN screen

1. Graph window: displays all curves currently selected for viewing 2. Remote control indicator: flashes when the remote control is in use 3. Information field: date, time and patient identification 4. Pressure window: pressures, sensor info, EQ info, heart rate and Pd/Pa 5. Menu window (MAIN menu buttons shown here) 8

RADIANALYZER®XPRESS – SERVICE MANUAL

6. Menu tree window: displays the menu tree, with current level highlighted. The STOP/VIEW screen shown in Fig. 6 is displayed when the user presses the STOP/VIEW button. If the instrument is recording, the recorded signal is displayed in the graph window. Otherwise the main graph is left empty and the default menu is MAIN/VIEW. The screen is similar to the MAIN screen. 3

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1 4

5 6

7 Figure 6. Radi Analyzer®Xpress STOP/VIEW screen

1. Graph window: displays all curves currently selected for viewing 2. Remote control indicator: flashes when the remote control is in use 3. Information field: date, time and patient identification 4. Pressure window: pressures and FFR at cursor position 5. Info window: recording length, cursor position and recording number 6. Menu window (VIEW menu buttons shown here) 7. Menu tree window: displays the menu tree, with current level highlighted

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2.1.2

Keypad and remote control

All controls and menu selections are done via the remote control or the keyboard, see Fig. 7. The keys on the instrument and remote control have the following functions:

Figure 7. RadiAnalyzer®Xpress keypad and remote keypad

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ARROW keys, left or right

Move the cursor (a vertical line) or highlighted button sideways to select a menu function.

ENTER key

Select item highlighted or enter information.

ESC key

Return to the previous menu level.

REC key

REC submenu. Start recording measurement.

EQUALIZE key

Balance the pressure difference between aortic- and PressureWire® pressure.

RADIANALYZER®XPRESS – SERVICE MANUAL

ON/STANDBY key

Start or place RadiAnalyzer®Xpress in standby mode (not available on remote control).

F1 key

Enter the AUTO SETUP menu.

STOP/VIEW key

Halt the recording and store it in memory. Open the VIEW screen and display the recorded measurements and the point of FFR.

MARKER key

Mark specific positions or events during recording or in view mode.

NOTE: When RadiAnalyzer®Xpress main unit is placed in standby mode (press and hold the ON/STANDBY key for 3 seconds) the display turns black. All the keys, except the ON/STANDBY key are disabled (the STANDBY INDICATOR will illuminate). Press the ON/STANDBY key to enable RadiAnalyzer®Xpress and the graphic display will turn on again and the STANDBY INDICATOR will turn off. WARNING: The mains power remains switched on when the system is in STANDBY mode.

2.2

Connectors main unit

Equipotentiality terminal

Optical serial port

Mounting bracket

Power supply unit

Figure 8. RadiAnalyzer®Xpress connectors main unit. RADIANALYZER®XPRESS – SERVICE MANUAL

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2.2.1

Optical serial port

Fiber optic connector Chassis connectors Manufacturer Part number Number of contacts Colour code

AMP 501381-1 Transmit/Receive RX/TX marked on label, RX is marked black.

Cable connectors (Fiber optic cable) Manufacturer Part number

RADI MEDICAL SYSTEMS AB 12741 (10 meter) 12742 (20 meter) 12743 (30 meter) ST 62.5/125 duplex multimode fiber White/black

Type Colour code

Specification Emitted power Transmission rate Transmission distance

2.2.2

< 16 dBm (not a laser) < 115 200 bit/second > 30 meter

Mains connector in Power Supply Unit

Power supply connector Type Number of contacts

Standard inlet IEC-320-C14 3

Cable connector (Power cable) Manufacturer Part number Specification Rated current

2.2.3

RADI MEDICAL SYSTEMS AB Contact RADI MEDICAL SYSTEMS AB Operating voltage 100-240 V 50-60 Hz 0.3 A (230 VAC), 0.5A (110VAC)

Equipotentiality terminal

Chassis connector Type

Standard pin DIN 42801

Cable connector Type

Standard socket for pin DIN 42801

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RADIANALYZER XPRESS – SERVICE MANUAL

Specification Resistance to accesible metal parts

2.2.4

< 0.2 ohm

Mounting bracket

Manufacturer Part number

RADI MEDICAL SYSTEMS AB Contact RADI MEDICAL SYSTEMS AB

Specification Pole diameter

15 to 30 mm

2.3

Connectors Signal Modules

2.3.1

AO Input

Figure 9. Front view chassis connector AO Input

Excitation +

Signal Jumper (shield connection)

Signal +

Excitation Not connected

5µV/V/mmHg

Electrical specification Excitation voltage Transducer excitation impedance Transducer signal impedance Transducer sensitivity Insulation

4 V DC > 200 ohm < 3000 ohm 5µV/V/mmHg CF

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Connector specification Fixed socket (chassis connector) Manufacturer Part number Number of contacts Colour code Straight plug (cable connector) Manufacturer Part number Number of contacts Colour code

2.3.2

ODU GX1M07-P07QF00 7 Red Lemo USA, Inc PAG.M0.7GL.AC52Z Bend relief GMA.1B.054. DR 7 Red

PressureWire® input Shield

Signal passive

Data I/O

Signal acti ve

Data I/O

Signal GND

Figure 10. Front view chassis connector PW Input

Electrical specification Excitation voltage Transducer excitation impedance Transducer signal impedance Transducer sensitivity Insulation

According to PW specification According to PW specification According to PW specification According to PW specification CF

Connector specification Fixed socket (chassis connector) Manufacturer Part number Number of contacts Colour code 14

ODU GX1ME7-P06QF00 6 White

RADIANALYZER®XPRESS – SERVICE MANUAL

Straight plug (cable connector) Manufacturer Part number Number of contacts Colour code

2.3.3

Lemo USA, Inc PAC.M0.6GL.AC39G 6 Grey

AO / PW output Excitation + Not connected

Hi Out -

Signal +

GND

Signal -

Hi Out +

Excitation -

Figure 11. Front view chassis connector AO/PW Output

Electrical specification Excitation voltage Transducer excitation impedance Transducer signal impedance Transducer sensitivity Insulation

4-8 V DC or AC 0-5 kHz > 200 ohm < 3000 ohm 5µV/V/mmHg CF

Connector specification Fixed socket (chassis connector) Manufacturer Part number Number of contacts Colour code

ODU GX1MA7-P08QF00 8 Green, Red

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Straight plug (cable connector) Manufacturer Part number

Number of contacts Colour code

2.4

Lemo USA, Inc PAA.M0.8GL.AC65GZ Bend relief GMA.1B.054.DR (red), GMA.1B.054.DV (green) 8 PW Output - Green, AO Output - Red

Classifications

Council directive 93/42/EEC (Medical Device Directive), Class IIb. RadiAnalyzer®Xpress is classified as follows in accordance with relevant parts in: IEC 60601-1-1 IEC 60601-2-34 IEC 60601-1-2 UL 60601-1 CAN/CSA C22.2 No. 601.1-M90 ANSI/AAMI BP 22-1994 • Class I equipment, the type of protection against electrical shock. • Type CF equipment, the degree of protection against electrical shock as indicated by the symbol. • Equipment not suited for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. • Continuous operation according to the mode of operation.

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3. ABBREVIATIONS AC AO CF DC EPT EQ FFR I/O Pa Pd PC PMS PSU PW RS232 RAN RTU

Alternating Current Aortic Pressure Cardiac Floating Direct Current External Pressure Transducer Equalize Fractional Flow Reserve Input/Output Aortic Pressure Distal Pressure Personal Computer Patient Monitoring System Power Supply PressureWire® Standard for serial data communication RadiAnalyzer® RadiAnalyzer® Test Unit

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4.

INSTALLING RADIANALYZER®XPRESS

4.1

Mounting the unit

CAUTION: Handle RadiAnalyzer®Xpress interface and accessories with care. Unpack the box and check that the following components have been supplied: • One RadiAnalyzer®Xpress interface with one remote control • Two monitor cables • One External Pressure Transducer (EPT) adapter cable • One mains cable • One RadiAnalyzer®Xpress Instructions For Use • One RadiAnalyzer®Xpress service manual (this manual) Before use, always check that all parts are present and undamaged. WARNING: Do not use the device if it has been dropped or in another way exposed to mechanical or electrical impact or if liquids have penetrated the housing, or the user or patient may be exposed to electrical shock or fault readings may appear. Contact your supplier for further action. WARNING: The device complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones etc shall not be used in the close proximity of the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that e.g. the HF-cables are not routed on or near the device. If in doubt, contact a qualified technician. 1. Attach RadiAnalyzer®Xpress main unit to a suitable stand using the mechanical adapter on the rear of the interface. Ensure that the mounting of RadiAnalyzer®Xpress interface is secure and that its position is stable. 2. Place the stand at the desired location in the cathlab.

4.2

Connecting the power supply

1. Connect the mains cable from the mains power connector on the Power Supply Unit to a grounded mains power outlet. If applicable, connect the equipotential terminal to the equipotential network used in the cathlab. 18

RADIANALYZER®XPRESS – SERVICE MANUAL

4.3

Connecting to cathlab monitoring system

RadiAnalyzer®Xpress interface can be connected to a cathlab monitoring system so that the waveforms can be shown on the monitor. Check that the monitor cables and EPT adapter delivered with RadiAnalyzer®Xpress interface are compatible with the cathlab system to be used. If not, the correct cables for the specific monitoring system can be ordered from Radi Medical Systems AB. 1. Connect the EPT adapter to the AO IN connector on the back of RadiAnalyzer®Xpress interface. 2. Connect the EPT to the EPT adapter. CAUTION: Verify that the External Pressure Transducer (EPT) is in accordance to ANSI/AAMI BP22-1994. 3. Connect the monitor cable from the AO OUT connector on the back of RadiAnalyzer®Xpress interface to the chosen AO IN port on the cathlab monitor system. 4. Connect the monitor cable from the PressureWire® OUT to the chosen PressureWire® IN port on the cathlab monitor system.

4.4

RadiAnalyzer® Printer Kit installation

Figure 12. Connecting printer to RadiAnalyzer®Xpress

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1. Connect the optical modem to the 9 pin connector on the back of the printer. See Fig. 12. Tighten the screws to lock the modem to the printer. 2. Use the optical fiber to connect the modem to the serial port connectors on the left side of RadiAnalyzer®Xpress according to: Optical Modem

Optical Cable

RadiAnalyzer®Xpress

Light grey connector

Connector TX

Dark grey connector

Connector RX

3. Connect the AC adapter to the power input on the printer and to a power outlet. 4. Turn the power switch on the printer to “1”. 5. Refer to the printer manual for ribbon and label loading. R 1,5 m

Patient environment

Figure 13. Patient environment

WARNING: The printer does not comply with medical electrical requirement and shall not be placed in Patient Environment. There is a risk of electrical shock causing a serious injury to the patient. See Fig. 13.

4.5

RadiView® setup

4.5.1

Product description

RadiView® Software is designed for digital transfer and printing of RadiAnalyzer® physiological recordings. PACKAGE CONTENTS • RadiView® Software CD • Optical modem • Fiber optic cable

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• Connection cable kit • Instructions For Use • Serial port test kit

RADIANALYZER®XPRESS – SERVICE MANUAL

INTENDED USE RadiView® is intended for review and printout of physiological measurements recorded by RadiAnalyzer®. RadiView® Software is NOT intended for analysis or manipulation of the original measurement data. MINIMUM SYSTEM REQUIREMENTS Windows 98/NT 4.0/2000 Pro Pentium II 300MHz or comparable processor 64Mbyte RAM 100 Mbyte hard drive space 800*600 screen resolution One PS/2 (mouse) port One serial port (COM)

4.5.2

Installation

CONNECT RadiAnalyzer®Xpress to a PC

Using Serial Port (RS232). See Fig. 14. 1. Turn off the PC before installation. 2. Connect the power adapter to the computer mouse port (A) and to the power input on the optical modem. Reconnect the computer mouse to the other end of the adapter cable. 3. Connect the serial cable (9 pin female-female) to a free serial port (B) on the computer and to the optical modem.

TX RX

A B

Figure 14. Installation of PC to RadiAnalyzer®Xpress using RS232 RADIANALYZER®XPRESS – SERVICE MANUAL

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