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i5 Platform for RF/DSA

Site Planning Guide

Supports generator integration

Supports multiple CCD cameras

Flexible and adaptable to site requirements

Technology that grows as imaging demands change.

February 201

Site Planning Guide: i5 Platform for RF/DSA

721-008-G1, Rev. C

The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional

film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5TM enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage, and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnos-tic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include a digital x-ray detector, computer, monitor, and imaging software.

For the RF/DSA application, the InfiMed i5TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy, or angiography imaging procedures are performed.

i5 Platform for RF/DSA, the i5, doc part # 721-008-G1, Rev. C, companion document 721-002-G1

InfiMed Customer Support

Call weekdays from 8:15 a.m.-5:00 p.m., USA - Eastern Standard Time (GMT -6) for assistance: TechnicalSupport & Customer Service, +1 315-453-4543. Parts & Order Services, +1 315-453-4545 x233.

InfiMed’s answering service is open from 5:00 p.m.-8:15 a.m. (Eastern Standard Time, GMT -6) and on weekends and holidays. A Customer service technician will respond to your inquiry as soon as possible.

Please have the following information ready before making your service call: System Serial Number (S/N),found on the identification tag on the rear of the PC, and software version. To find the software version, click on the InfiMed logo (top of main menu in Clinical Mode) for the About screen, or look for the Versionsbutton toward the bottom of the Service Mode menu.

Thank you for choosing InfiMed.

Site Planning Guide: i5 Platform for RF/DSA

Site Planning Guide: i5 Platform for RF/DSA i

i5 Platform for RF/DSA

Site Planning Guide

Supports generator integration

Supports multiple CCD cameras

Flexible and adaptable to site requirements

ii Site Planning Guide: i5 Platform for RF/DSA

i5 Platform for RF/DSA, an innovative diagnostic digital imaging application by InfiMed, Inc.

© 2010 InfiMed Inc. All Rights Reserved. InfiMed Site Planning Guide, part number 721-008-G1, Rev. CInfiMed hereby grants its customers the right to reproduce this manual. For electronic files, contact InfiMed Technical Publications at +1 315-453-4545 x232.

Revision History

Revision Date ECN Software reference Description of release & change pages

C February 2010 xxxx xxxx i5 Platform for RF/DSA

InfiMed, i5, iCynergy, and InfiVision are trademarks of InfiMed, Inc. SEDECAL is the company name of Sociedad Espanola de Electromedicina y Calidad, S.A. CPI is a brand name of Communications & Power Industries. Windows and Windows XP are trademarks of Microsoft Corp.

While every precaution has been taken in the preparation of this book, InfiMed assumes no responsibility for errors or omissions or for damage resulting from the use of the information contained herein. The infor-mation in this manual is subject to change without notice.

Applicable standards & complianceFDA 510(k)CE Mark to MDDETL approvedCAN/CSA C22.2 No. 601-1IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4UL 60601-1IHE Integration (see Appendix A)

EU Authorized Representative:Medical Device & QA Services76, Stockport Road, Timperly, Cheshire UK, WA15 7SNEmail: [email protected]

This product conforms to the necessary IEC standards for patient safety and isolation as it is shipped from

the factory. It is the responsibility of the end user and/or the installer to insure that when connected, as a

system with other devices, all the rules of IEC60601-1-1 are met.

HIPAA logging: The InfiMed i5 Platform supports HIPAA Access Control Standards. Unique user identifica-

tion and automatic logoff are implemented through user configuration and the login/logoff features of the

Clinical mode. HIPAA Audit Control Standards are used in the Service Mode logs to record user actions.

2/3/10

Welcome

The i5 platform adapts to the needs of the user. Its menu interface may be customized, and it sup-ports multiple CCD cameras. The i5 defines convenience. InfiMed's open platform allows the tech-nologist to adapt on the fly to changes in the industry and to clinical requirements.

InfiMed's i5 platform

InfiMed's i5 platform is specifically designed for routine radiographic exposures where the image is cap-tured on a digital sensor and stored as an electronic patient file in the computer. Acquired images are instantly viewable; so, there is no need to wait for film development. The i5 platform presents an intuitive touch screen. It supports cutting-edge CCD camera technology and offers integration with x-ray genera-tors.

The i5's user-friendly interface is tailored to exceed the needs and requirements of today's busy work envi-ronment. It standardizes and minimizes the steps required from image acquisition to optimal viewing.

User customizable workflow and acquisition profiles to optimize patient throughput and image quality. With the use of advanced image processing algorithms, premium image quality is realized on the first view. Patient through-put is enhanced while minimizing user intervention by reducing or eliminating the need for retakes.

This Site Planning Guide provides the dealer, service technician, and end-user of the InfiMed digital imag-ing systems a basis for thinking ahead about how the hardware will be accommodated in the space allo-cated for it. Use the descriptions of the hardware components, cabling needs and limitations, and the power and safety requirements to prepare the space. Please also note the safety cautions and the sys-tem’s electromagnetic compatibility factors.

When you receive your system from InfiMed, this information will again be included — with additional detail — in the Service Manual. Additionally, InfiMed is glad to answer questions about its systems. Just call Cus-tomer Care at +1 315-453-4543. For order services, please phone +1 315-453-4545 x233.

We are pleased that you have chosen InfiMed. Thank you.

Site Planning Guide: i5 Platform for RF/DSA iii

iv Site Planning Guide: i5 Platform for RF/DSA

Contents

Part 1. Assemble the i5 System 1

CHAPTER 1 Equipment Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Warranty 3Safety 4Electromagnetic compatibility 4

CHAPTER 2 Room Readiness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

CHAPTER 3 Hardware Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

PC tower 11Pointing devices 13Generator interface module (GIM) 13Camera 14Power requirements 16

CHAPTER 4 Cabling Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Inventory of cables 21Cable connections 24

Part 2. Appendixes 29

APPENDIX A Statement of IHE Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

APPENDIX B Installation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Site Planning Guide: i5 Platform for RF/DSA v

vi Site Planning Guide: i5 Platform for RF/DSA

Figures

FIGURE 1. Tower PC, monitor, mouse, & keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

FIGURE 2. GIM — with cover removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

FIGURE 3. Left: Assemble the camera. Right: Attach camera. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

FIGURE 4. Left: Remove iris. Right: Remove cable cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

FIGURE 5. Left: Remove the cable clamp. Right: Attach camera to connector . . . . . . . . . . . . . . . . 16

FIGURE 6. Isolation transformer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

FIGURE 7. UPS, power conditioner combo unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

FIGURE 8. Arrangement of power supply components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

FIGURE 9. External ground screw head stud . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

FIGURE 10. PC connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

FIGURE 11. Rear of PC: Video & Ethernet connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

FIGURE 12. Inside GIM cover: diagram of connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Site Planning Guide: i5 Platform for RF/DSA vii

viii Site Planning Guide: i5 Platform for RF/DSA

Part 1. Assemble the i5 System

Site Planning Guide: i5 Platform for RF/DSA 1

2 Site Planning Guide: i5 Platform for RF/DSA

CHAPTER 1 Equipment Handling

Warranty

U.S. law restricts this device to sale by or on order of a physician for diagnostic digital radiographic use

only. Any of the following actions voids the manufacturer's warranty1:

• Modification, abuse, misuse, neglect, or operation at ambient temperatures below 50ºF or above

90ºF (10ºC, 32Cº) or at other abnormal conditions. Ambient operating temperature for the isolation

transformer is 64-86ºF (18-30ºC). See also Table 1 on page 4.

• Use of any software not supplied by seller

• Use of supplied software and hardware outside seller's guidelines or applicable standards

• Unauthorized repair or alteration.

Upon receipt of your shipment from InfiMed, inspect packaging and components. If anything appears to be

damaged, contact InfiMed immediately. Do not proceed if any components or cables are missing or dam-

aged.

Equipment classification

Protection against electric shock - class IDegree of protection against electric shock - type BDegree of protection against ingress of water - OrdinaryMode of operation - Continuous

1. InfiMed, Inc. Terms and Conditions of Sale. Part No. 200.267.G1. Sept. 5, 2006.


1. EQUIPMENT HANDLING

Safety

Apply the directions here precisely to avoid damage to the System or any of its components, yourself, or others, loss of data, or corruption of files. The manufacturer assumes no liability for failure to comply.

.Operate the electronic components, including the isolation transformer, within the parameters listed in Table 1 (MiscH2, MiscH3, MiscH4).

TABLE 1. Environmental parameters

Computer & peripherals Isolation transformer

Transport & store Operate Operate

Temperature -4–131ºF (-20–55ºC) 50–90ºF (10–32Cº); 64–86ºF (18–30ºC)

Humidity 10–95% noncondensing 20–75% noncondensing 20–75% noncondensing

Air pressure 700–1060 hPa (10–15 lb/in2, 0.7–1.0 atmosphere)

700–1060 hPa (10–15 lb/in2, 0.7-1.0 atm)

700–1060 hPa (10–15 lb/in2, 0.7-1.0 atm)

Electromagnetic compatibility

The System complies with EN 60601-1-2:2001-09 Section 6. Prevent the potential risk of electromagnetic interference between this equipment and other devices. The device has been tested for EMC compliance, but interference can still occur in an electromagnetically noisy environment. Maintain a suitable distance between electrical devices to prevent cross-interference. The PC cabinet should be as far as possible from any such device to prevent noise from affecting the image video signal.

Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided here. Portable and mobile RF communications equipment can affect medical electrical equipment.

Suggested optimum usage: Do not place equipment or system adjacent to or stacked with other equip-ment. Take extra precaution to verify normal operation of the configuration used at the site.

Use the following guidance tables for emissions and separation distances:

Table 201 – EmissionsTable 202 – ImmunityTable 204 – Emissions, not life-supportingTable 206 – Separation distances, not life-supporting

Guidance and manufacturer’s declarationTable 201. Emissions - All equipment and systems (IEC 60601-1-2:2001-09 Sec 6:6.8.2.201)



The i5 system is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment guidance

RF emissions CISPR Group 1 The i5 uses RF energy only for its internal function. therefore, its RF emissions are very low and are unlikely to cause any interference in nearby electronic equip-ment.

RF emissions CISPR 11 Class A or B Class A

Harmonics IEC 61000-3-2 Class A, B, C, D or NA Complies

Flicker IEC 61000-3-3 Complies or NA Complies

The i5 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.

RF emissions CISPR 14-1 Complies The i5 is not suitable for interconnection with other equipment

RF emissions CISPR 15 Complies The i5 is not suitable for interconnection with other equipment

Guidance and manufacturer’s declarationTable 202. Immunity - All equipment and systems not life-supporting (IEC 60601-1-2:2001-09 Sec 6:6.8.2.201a)The i5 system is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.

Immunity test EN/IEC 60601 test level Compliance level Electromagnetic environment - guidance

ESD EN/IEC 61000-4-2

±1 kV I/OsMains power quality should be that of a typical com-mercial or hospital environment.

±2 kV common ±2 kV commonMains power quality should be that of a typical com-mercial or hospital environment.

Voltage dips/dropout EN/IEC 61000-4-11

>95% dip for 5 s >95% dip for 5 s

Mains power quality should be that of a typical com-mercial or hospital environment. If the user of the i5 requires continued operation during power mains interruptions, it is recommended that the i5 be pow-ered from an un interruptible power supply or bat-tery

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

3 A/m 3 A/m Power frequency magnetic fields should be that of a typical commercial or hospital environment.

Guidance and manufacturer’s declarationTable 204. Emissions - All equipment and systems not life-supporting (IEC 60601-1-2:2001-09 Sec 6:6.8.2.201b)The i5 system is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.

±6 kV contact±8 kV air

±6 kV contact±8 kV air

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

EFT EN/IEC 61000-4-4 ±2 kV mains±1 kV I/Os

±2 kV mains

Surge EN/IEC 61000-4-5 ±1 kV differential ±1 kV differential

>95% dip for 0.5 cycle

60% dip for 5 cycles


>95% dip for 0.5 cycle





Immunity testEN/IEC 60601

test levelCompliance

level Electromagnetic environment - guidance

(V1)Vrms

(E1)V/m80 to 800 MHz

Interference may occur in the vicinity of equipment containing a transmitter

Recommended separation distances between portable and mobile RF communications equipment and this system

Table 206. Equipment and systems not life-supporting (IEC 60601-1-2:2001-09 Sec 6:6.8.2.201b)The i5 system is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the i5 can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the i5 as recom-mended below, according to the maximum output power of the communications equipment.

Separation (m) at:

Max output power (watts)

0.01 0.1166 0.2333

0.1 0.3689 0.7378

1. 1.1666 2.333

3.6893 7.3786

100. 11.6666 11.6666 23.3333

Portable and mobile communications equipment should be separated from the i5 by no less than the distances calculated/listed below:

Conducted RF EN/IEC 61000-4-6

3 Vrms150 kHz to 80 MHz

D=(3.5/V1)(√P)

Radiated RF EN / IAC 61000-4-3

3 V/m80 MHz to 2.5 GHz

D=(3.5/E1)(√P)

D=(7/E1)(√P)800 MHz to 2.5 GHzWhere P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1)

150 kHz to 80 MHzD=(3.5/V1)(√P)

80 to 800 MHzD=(3.5/E1)(√P)

800 MHz to 2.5 GHzD=(7/E1)(√P)

0.1166

0.3689

1.1666

10. 3.6893


CHAPTER 2 Room Readiness

The i5 system is shipped in several boxes banded to a standard wooden pallet. Keep the boxes upright at all times.

A packing list is attached to the out-side of one box. Check this packing list when you first receive the ship-ment or if the items have been removed from the pallet when they are delivered to the x-ray room.

The i5 system is composed of sensitive electronic devices. Follow caution stickers regarding careful han-dling. We recommend that you leave the components in their packaging until it is time to assemble them on site.

To save time when troubleshooting problems and for the best image quality, the x-ray room components and peripheral devices must be in place, working properly, and configured before installing the i5 system. Check that the following are in place.

Pre-installation site survey. InfiMed requires that dealers of our products assess the facilities into which the i5 system will be installed. We give them a short form, the Pre-installation Site Survey, to com-plete. They submit the Survey to InfiMed, and it helps us to send the correct equipment. This sur-vey should be helpful to the installer of the system, too. Therefore, if you do not have the completed version of the Pre-installation Site Survey, check with the administrator of the organiza-tion that purchased the i5 system. If necessary, contact InfiMed Customer Care to see if a copy was submitted (+1 315-453-4543) or if you have any questions or problems.

Packing list. For a copy, call InfiMed Order Services at +1 315-453-4545 x233.

Room layout. Discuss with the site personnel the preferred location for each component. Sketch the room layout to assist with placement of the components and cabling of the i5 system.

Required.

InfiMed requires submission of an installation report within 30 days of first clinical use of the i5 system.

See appendix in this Manual. The form is also available on our website. On the website, use username generator and password Generation5, and go to http://infimed.com/assets/care_files/documentation/726-105-G1.pdf. Or contact InfiMed Customer Care at +1 315-453-4543.

Thank you.


2. ROOM READINESS

Enough shelf or table space. A flat work surface (table or cart) is required to hold the operator controls. Check that the area has enough room for comfortable use of the keyboard and pointing device and that the table or cart is at a suitable height. If space is limited, consider using a retractable key-board shelf (not supplied by InfiMed).

Suitable conduits. Refer to later chapters in this Manual for details on required cables, routing restric-tions, cable sizes and lengths. Also, consider cables for other devices in the x-ray room and con-trol room. See that there is an acceptable path for each cable.

Generator functioning. The generator must function properly before making any connections between it and the i5 system.

Optics cube. The x-ray system must be equipped with devices that allow the camera to view the output phosphor of the image intensifier during fluoroscopy, photos pots, and Cine acquisi-tion - depending on the type of room.

Fluoro dose control. Control of fluoroscopic kV and mA can be implemented either internally from the x-ray system through output sampling by image intensifier or from automatic bright-ness stabilization (ABS) feedback from the camera. If camera-based ABS feedback is used, the x-ray system requires dedicated circuits to receive the ABS feedback signal from the camera.

Photospot dose control. The x-ray system must control the x-ray dose during photospot acquisition by sampling the image intensifier. The exposure consistency of the photo-timer must be within ±10%. The photo-timer must be capable of controlling the dose of the photospot acquisition at a rate of up to 15 frames per second (fps), must be self-resetting after each exposure, have a resolution of 1 ms or less, and be capable of 70% sampling field size.

Photo-timing circuit for spot radiographs. A photo-timing circuit (also called automatic exposure control, AEC) must be present for the i5 Platform for RF/DSA to function properly. Check the generator’s specifications to ensure that the option is available, and locate the exact wire locations. If the option is not present, it must be ordered from the x-ray generator’s manufacturer.

Generator limits. InfiMed recommends an image intensifier with (used equipment) at least 80% of its factory test Gx (a gain multiplier) or (new equipment) with a minimum of 150 Gx.

Pulsed fluoro. To use the pulsed fluoro of the i5 Platform for RF/DSA, the generator must support pulsed fluoro. Pulsed fluoro configuration:

Radiation pulse on (FL PULSE ON) for pulsed fluoro systems only, RAD PULSE ON for systems that support Cine). RAD PULSE ON indicates that the generator is producing an x-ray expo-sure. This pulse must be active for at least 1 ms but no more than 15 ms. Pulse fluoro tim-ing, polarity, and rates must be configured in Service Mode.

Exposure rate. Review the generator’s specifications. If the generator cannot handle 15 fps spot imaging, notify site personnel and configure the i5 accordingly. Camera mount type. The type of camera mount required should have been determined when the InfiMed Pre-installation Site Survey was completed. If the Pre-installation Site Survey is not available, consult the image intensifier’s manual; alternatively, look at the existing camera to determine the type of mount needed. Then, verify with the packing list that the correct mount was sent.


2. ROOM READINESS

Power source. If the power source does not meet criteria as outlined in the next chapter of this Manual, install the InfiMed power conditioner. See page 16.

Image monitors. Consult site personnel to determine preferred location of image monitors. Monitors are shipped with removable bases. InfiMed recommends you remove the tilt-swivel base from monitor before mounting monitor to an unstable surface such as a cart or hanging bracket. If using a cart, InfiMed recommends that you attach a handle to the cart for safe use of the cart and monitor. To attach the monitor to a cart or to a hanging bracket, consider how the monitor will be attached to the surface.

Blank disks. Testing the i5 recording capabilities requires at least one CD or DVD.

Network drop. The site must provide the network connection cable. Work with the site's network adminis-trator to have this arranged. The i5 system supports 10/100/1000 Base-T connections.

Network information. The network address and host name information must be obtained from the local network administrator. This information can then be entered into the i5 system when the system parameters are set.

Remote DICOM services. The site must provide connectivity data for DICOM service classes, print, store, worklist, and so forth that are necessary for the particular site. Refer to the Pre-installation Site Survey for data forms, or contact InfiMed Customer Care (+1 315-453-4543).

Basic tools needed.

Digital volt-ohm meter (20,000 Ω/V)Phillips #1 and #2, blade type 1/8-inch, 1/4-inch, and flat-blade screwdriversMetric hex key set (1.5 to 6 mm)Socket set (to 1 inch with appropriate driver)DosimeterRulerESD wrist strapX-ray phantoms: line pair resolution and 15-cm Lucite (homogeneous density).


2. ROOM READINESS


CHAPTER 3 Hardware Components

The components that InfiMed ships depend on each customer’s selected options.

Open each box of the InfiMed imaging system, and identify all parts against the packing list. Don’t discard the packaging. The electronic devices are best left in the original anti-static bags and foam cushioning until needed for installation. Please check the following:

• Examine each piece, including containers, for damage.

• Check cable connectors for bent or damaged pins.

• If any component appears damaged, contact InfiMed Order Services at +1 315-453-4545 x233.

Review the hardware (this chapter) and cables (chapter about x-ray detector); then, begin layout and, afterward, connections.

PC tower

The rear panel of the PC has fragile components. Use care when removing the unit from its packaging and when positioning it.

InfiMed ships the i5 Platform with a tower PC (model S3210SHLC, InfiMed part number 723-980-G2, Figure 1). The PC cabinet contains motherboard, hard drive, CD/DVD disc drive, power supply, dual-port serial card, video card, multiple USB ports, and on-board Ethernet

The PC also includes InfiMed's proprietary Image acquisition, processing, and display board (IAPDB), a component that is integral to the functionality of the i5 Platform for RF/DSA.

InfiMed ships a complete system with specific compo-nents to match each cus-tomer’s selected options.


3. HARDWARE COMPONENTS

FIGURE 1. Tower PC, monitor, mouse, & keyboard

The PC tower is usually positioned in the control room near the primary monitor, keyboard, and pointing device. Locate it within

• 100 cable ft of the x-ray generator control cabinet for connection to the generator integration module (GIM).

• 100 cable ft of the image intensifier to connect to the CCD camera.

Note: Keep the PC tower beyond a 6-ft radius of the x-ray table. Pay careful attention to other equipment in the room that generates high frequency signals, and place the PC tower as far from such equipment as is feasible. Such placement helps to prevent the noise from affecting the image video signal.

Allow sufficient space around the PC tower to permit service personnel to gain access inside its cabinet. Keep a minimum of 4 inches of clearance at the front and rear of the PC tower for ventilation. The PC tower must be placed on a flat level surface and checked for stability. If necessary, use a PC stand.

The i5 Platform uses an LCD touch screen monitor (InfiMed part number 855-044-G1). Commonly, a key-board, mouse, and monitor are located in the control and additional monitor(s) and a pointing device are located in the exam room. room. See Table 2 for specifications, including regulatory requirement, for the monitor.

TABLE 2. Monitor specifications

Resolution (aspect ratio) 1280 x 1024 (5:4)

Contrast ratio ≥ 400:1

Input video signal DVI-D, DVI-A, or DVI-I

Touch screen interface RS-232C or USB

Brightness ≥ 250cd/m2 max (white luminance)

Regulation IEC-60601, CE

Control room monitor. Position the monitor within 6 cable ft of the PC and within 6 cable ft of the isolation transformer (or within 100 ft if the 100-ft extension cord is used). The control room monitor may be, but need not be, powered from the isolation transformer (Figure 6) or the optional UPS-power con-ditioner (Figure 7). When multiple monitors are used, a VGA splitter with VGA extension cords connects to the PC tower. The VGA splitter has a 2-ft cable and, therefore, should be located within 2 ft of the PC tower.



Exam room monitor(s). The i5 Platform for RF/DSA can accommodate a second monitor, a reference monitor placed to the right of the main exam room monitor. Use a 100-ft extension cable from the PC tower to this monitor. These monitors have medical-grade power supplies and may be pow-ered from inside the x-ray generator's control cabinet or from a convenient wall outlet.

Power to monitor. If the optional UPS-power conditioner is being used, we recommend that at leastthep-rimarymonitor be powered through it. Such an arrangement permits the monitor to remain on while the patient exam is closed and the i5 system safely powered down. Power extension cables may be purchased from InfiMed or fabricated to the prevailing electrical and fire codes.

Pointing devices

The most common pointing device is a mouse, but other devices include track balls or touch pads. If the exam room monitor is located on a cart, a trackball is often used and located on the cart. If the monitors are suspended, a touch pad is often used. It is attached to the housing of the image intensifier or a similar area that is within easy reach of the technologist.

Use a keyboard splitter or a pointing device splitter to add additional devices. Note that both splitters are similar in appearance but function differently. Each is appropriately marked to indicate the device connec-tions. The pointing device splitter and the keyboard splitter must be attached directly to the PC tower with the extension cables for the devices attached to the splitters. The splitters will not function properly if attached to the remote end of an extension cable.

Generator interface module (GIM)

The generator interface module (GIM) is a white metal box 12 x 12 x 2½ inches. (305 x 305 x 63 mm); see Figure 2 which shows the GIM with its cover off. Interface signals that connect the i5 Platform for RF/DSA to the host x-ray system are input and output from the remote DR generator interface module (DR GIM). The DR GIM contains the inputs and outputs listed in Table 3:

TABLE 3. GIM inputs & outputs

Number Input or output

32 Two-state input circuits These inputs and outputs are used in the standard generator inter-face scheme.

12 Relay outputs

1 Analog ABS output

4 Open collector drive outputs

4 RS-232 serial ports

2 CAN bus ports

8 Analog voltage inputs



FIGURE 2. GIM — with cover removed

Put the GIM inside the x-ray generator's control cabinet or within 25 cable ft of the cabinet. It must also be within 100 cable ft of the PC tower. The GIM is typically powered from within the x-ray generator's control cabinet. It is equipped with a medical-grade power supply, and may be powered from a convenient wall outlet (within 6 cable ft).

Note: The GIM has an opening through which cables are routed. If the GIM is installed on the wall or the side of the x-ray generator cabinet, make sure that this opening is facing down. Such positioning prevents any contact with live parts or parts that might become live in a single-fault condition.

Camera

The CCD camera assembly is configured specifically for each site based on the information supplied to InfiMed from the Pre-installation Site Survey. The camera mount is always shipped with the system (A in Figure 3, left). An afocal adapter is sent only where necessary (B in Figure 3, left). Three sizes of Allen wrenches are needed to assemble the camera: 2, 2.5, and 3 mm. The camera will be attached to the image intensifier's output housing. The camera must be within 100 cable ft of the PC tower.

FIGURE 3. Left: Assemble the camera. Right: Attach camera.



Assemble and mount the camera

1. Attach the afocal adaptor (if used) to the camera. See Figure 3.

2. Attach the mounting plate to the afocal adaptor using the hardware provided. If no afocal adapter is being used, attach the mounting plate directly to the camera. There are several versions of the mount-ing plate, and the one in use at your site depends on the model of optical distributor present at your site. Figure 3 shows the most common 4-inch dovetail version.

3. Securely attach the camera assembly to the optics port. Verify that it has sufficient clearance in all x-ray table positions. See Figure 3 (right).

Route the camera cable

Note: Make sure that the PC tower is turned off before you connect the camera cable to the camera. These steps show you how to cable the camera.

FIGURE 4. Left: Remove iris. Right: Remove cable cover

1. Remove the iris cover (Figure 4, left).

2. Remove the cable cover (Figure 4, right).

3. Remove the cable clamp (Figure 5, left).



FIGURE 5. Left: Remove the cable clamp. Right: Attach camera to connector

4. Remove the top cable clamp.

5. Slide the iris cover over the cable so that it may be reattached later.

6. Attach the camera to the connector. Route it through the clamp, around the lens, and out of the camera (Figure 5, right).

7. Replace the cable clamp. Make sure that it tightly grips the ferrule on the cable but does not pinch the iris cable.

8. Replace the cable cover. The iris cover may be replaced now, but it must be slid back again when the camera is calibrated. See “Camera” on page 26 for further instructions on cabling the camera to the full system, but most other connections to the PC tower and power are made before the camera is con-nected to the PC tower.

Power requirements

The i5’s system power must meet the specifications in Table 4. Power must be from a dedicated AC line. Dedicated is defined as having no other branch circuits and the outlet is powered directly from a circuit breaker in the local AC distribution panel.

TABLE 4. System power specifications

Power phase V Hz A

Single 90 - 132 50 / 60 8

Single 198 - 242 50 / 60 4

Power must be free of noise, spikes, surges, and brownouts that exceed the nominal voltage by ±10%. If these conditions cannot be met, the optional power conditioner is required (see Figure 7). The following conditions must also be met:



• Peak impulse levels (line to neutral) are to be under 100 V peak above nominal (peak time interval 2 ms or less).

• The neutral wire must be the same gauge as the line wire.

• Frequency requirements are: 60 Hz system: 60 Hz ±0.5 Hz, 50 Hz systems: 50 Hz ±0.5 Hz.

• Neutral to ground potential: 2 V p-p or less.

• For sites using 230 V AC, an approved male plug must be used on the isolation transformer (Figure 6) provided it has ratings of 250 V AC and 5 A or greater.

FIGURE 6. Isolation transformer

Isolation transformer

Use the isolation transformer (Figure 6) to supply power to the i5 system. Do not simply plug the i5 system into a wall plug. The isolation transformer powers all components of the i5 system and is normally posi-tioned under the table or counter that holds the monitor and PC. Position the isolation transformer within 6 ft of the wall power source. The isolation transformer is considered a multiple portable socket outlet (MPSO). Locate in accord with the prevailing electrical and fire codes. SeeTable 5 for specifications.

TABLE 5. Specifications for isolation transformer

115 V AC 230 V AC

Input voltage 115 V AC nominal

50/50 Hz

Input current 8 A RMS maximum

230 V AC nominal

50/60 Hz

Input current 8 A RMS maximum

Output voltage 115 V AC (±4%)

50/60 Hz

Output current 7 A RMS minimum

115 V AC (±4%)

50/60 Hz

Output current 7 A RMS minimum

Leakage current 99 µA max at full load 99 µA max at full load

Power outlets Four standard North American style female receptacles (NEMA-5-15)

Fault protection Two 8-A circuit breakers

Cautions regarding the isolation transformer

To reduce the risk of electrical shock, do not remove the cover. Refer servicing to qualified personnel. Grounding reliability can only be achieved when connected to an equivalent receptacle marked hospital grade. The outlets on the isolation transformer output 115V AC (±4%). See Table 1 on page 4 for environ-mental parameters.



FIGURE 7. UPS, power conditioner combo unit

UPS, power conditioner

The uninterruptible power system (UPS, Figure 7) may not be placed on the floor.1 Mount it in such a way to prevent the ingress of liquids and to avoid mechanical damage during normal use. Input power is 120 V AC, 9.2 A, 50/60 Hz. output power is 120 V AC, 1000 V A. See Figure 8 for placement of the UPS combo unit, if used.

FIGURE 8. Arrangement of power supply components

1. IEC 60601-1-1.1.



FIGURE 9. External ground screw head stud

Additional electrical equipment

• Grounding: External ground screw head stud (Figure 9)

• Detachable hospital-grade power supply cord, Pacific Electricord C-5720-010-GY or equivalent.


CHAPTER 4 Cabling Components

Place each component in its intended location. Consider cable lengths, but do not make any cable connec-tions until layout is complete (see instruction beginning on page 24).

If issues arise regarding component placement, use the location criteria presented in “Hardware Compo-nents” on page 11 with the description of each component. The layout criteria were guided by the goal to achieve safety and optimal image quality.

Inventory of cables

Cables used to configure the hardware of the i5 Platform are listed in Table 6 below. The number of cables that is required for the i5 Platform for RF/DSA is unique for each site’s configuration.

Safety considerations

• Use only cables supplied by InfiMed, unless specifically noted below. Use InfiMed-specified exten-sion cables, if necessary.

• All components must be powered off when making cable connections.

• Do not connect any x-ray generator interface signal cables yet.

• The PC tower must be powered through the isolation transformer supplied by InfiMed. Do not plug the PC into a wall plug.

• If you are using the optional UPS-power conditioner, power it from the isolation transformer. Then, power the tower PC from the UPS-power conditioner.

• All cable connections to the tower PC are made in the rear.


4. CABLING COMPONENTS

TABLE 6. Cables

Power source - powered compo-nent

Power cable

Standard 3-prong plugs

6 ft

GIM - x-ray gener-ator

726-086-G1, Two-state input cables

25 Ft

4 or 5 cables shipped, depending on system configuration and options ordered.


726-087-G1, relay cables

25 ft

4 or 5 cables shipped, depending on system configuration and options ordered


068-044

50 ft, optional 100 ft available

Used as ABS cable

PC tower - GIM 735-731-G1, Ethernet crossover cable

100 ft

CAT 5

Ethernet crossover cable may be modi-fied for length.

PC tower - key-board

726-088-G1, Optional extension cable for keyboard

100 ft

Do not modify



PC tower - point-ing device

726-088-G2, Optional extension cable for mouse

100 ft

Do not modify

PC tower - CCD camera

723-234-G1, LVDS cable

100 ft

Black cable, molded camera connector

Do not modify the camera cable for length. Do not disassemble it for routing purposes. Care-fully check each end for damage. Be aware of which end con-nects to the PC tower and which con-nects to the camera. The ends are not interchangeable.

PC tower - PC tower

723-521-G1, CFI cable

12 ft

Allows graphics overlay to be generated through the display board onto IAPDB

VGA splitter - monitor

Optional VGA extension cable

100 ft

Do not modify this cable for length.

Depending on the number of monitors in the exam room, one or two VGA cables are fun from the PC tower to the exam room. If power extension cables are used to power the monitors from the UPS-power conditioner, run them at the same time.

PC tower - moni-tor

PC tower - VGA splitter

Optional VGA splitter input cable

3 ft

PC tower - x-ray generator

Optional CPI generator integration cable

TABLE 6. Cables (Continued)



Cable connections

Cabling is completed in the following sequence:

1. PC system

2. Camera

3. Power supplies

4. GIM to x-ray generator.

When cabling the components, leave a service loop for each connection at the PC tower or camera to accommodate minor repositioning during calibration or service. Roll or fold the excess cable such that it does not place undue stress on the cable, and place it in a safe unseen area.

PC connections

External cables are installed through the rear panel of the PC cabinet. There is no need to remove the back panel to make these connections.

The cables as they should be arranged at the rear of the PC chassis are illustrated in Figure 14. Note the loop back cable that connects the graphics card with the IAPDB.

FIGURE 10. PC connections

DVI loop back cable. Connect the DVI loop back cable first.

PC tower cables. Connect the remaining cables to the back of the PC tower as shown in Figure 14.



Control room monitor connections

The i5 Platform for RF/DSA supports dual primary display monitors. Only one of these may be a touch screen. A third monitor — a reference monitor — is also supported. Note: Any combination of monitors may be used, but InfiMed recommends that whenever two monitors are placed side-by-side that they be of the same type.

The standard control room monitor is a color touch screen monitor. It has both video (VGA) and communi-cation (USB or RS-232) connections to the PC tower. Refer to Figure 11.

FIGURE 11. Rear of PC: Video & Ethernet connections

1. Connect the monitor power supply to the monitor.

2. Connect the monitor VGA cable from the monitor to the VGA splitter.



3. Connect either the monitor USB or RS-232 - whichever is used (not both). Note: For short distances where the monitor is near the PC tower, connect the USB cable from the monitor to any USB port on the rear of the PC tower. For distances greater then 12 ft, connect the monitor RS-232 serial cable to COM1 on the rear of the PC tower. If you need to purchase a longer RS-232 serial cable, obtain one of high quality.

Exam room monitors connections.

1. Connect the monitor power supply(ies) to the monitor(s).

2. Connect the VGA extension cable from the VGA splitter to the primary monitor.

3. Connect the optional VGA extension cable from the PC tower to the optional reference monitor.

GIM connection

Connect the Ethernet crossover cable from the GIM's Ethernet connection (see Figure 2 on page 14, far upper-left corner) to the PC tower. Do not connect any generator interface cables at this time.

Hand held scanner (if used). Connect the hand held scanner's USB cable to an available USB port on the PC tower. No drivers or other software needs to be installed for the bar code scanner.

Camera

While the power is off and after the PC has been cabled, it is time to cable the camera to the PC. See Table 6 on page 22, part number 723-234-G1.

Power connections

Refer to Figure 8 on page 18. Plug the isolation transformer power input cord into the dedicated line's wall socket:

(a) If you are not using a UPS-power conditioner, plug the PC tower and control room monitor into the outlets of the isolation transformer.

(b) If you are using a UPS-power conditioner, plug its power input cord into the isolation trans-former outlet, and plug the PC tower, control room monitor, and (optionally) the exam room moni-tor(s) into the outlets of the UPS-power conditioner.

Once all component power cables have been plugged into the isolation transformer, feed the cables through the openings in the isolation transformer cover, and attach the cover using four screws.

Connect the GIM power cord to its source, and plug it into the GIM power inlet.

If the exam room monitor(s) power is not yet connected, connect the power cords from their power source to the monitor power supply.



Connect GIM

Interface diagrams for the GIM and several x-ray generators are available from InfiMed. On the website, use username generator and password Generation5, and go to http://infimed.com/customercare_interfaces.php, or call Customer Care at +1 315-453-4543. For the appropriate connection points, refer to documentation provided by manufacturer of the x-ray genera-tor.

Preparation

• Examine the room layout to plan how you will route the cables.

• If necessary, refer to the cable drawings to identify the cables that are provided (Table 6 on page 22). More than one of each cable may be provided with the i5 Platform for RF/DSA, depending on the number of signals to be used. The cables are identical when shipped. You must mark them individually to differentiate between each port. Up to eight input ports and four output ports are available; so, make this distinction before cables are routed. A 50-ft roll of four-conductor cable is included. Use it for the ABS and fluoro V-drive connections.

• Review the GIM signal definitions (tables below) to determine which signals will be used.

• Study the GIM internal diagram for locations of points of connection (see location of this diagram in Figure 12).

FIGURE 12. Inside GIM cover: diagram of connections

In preparation for connect-ing the GIM and the x-ray generator, take the following steps:

Power off all components of the i5 Platform for RF/DSA.

Unplug the GIM power cord.

Power down the x-ray gen-erator.

With the cables labeled, connect them to the GIM as indicated below.

Make no connections yet to the x-ray generator.


Part 2. Appendixes


APPENDIX A Statement of IHE Integration

TABLE 7. IHE Integration Statement, May 4, 2009

Vendor Product name Version

InfiMed InfiMed i5 1.0

This product implements the transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors, and Options listed below:

Integration Profile Implemented Actors implemented Options implemented

Scheduled workflow Acquisition modality PPS exception management

Broad worklist

Patient based worklist query

Assisted acquisition protocol setting

Performed procedure step manager None

Patient Information reconciliation Acquisition modality None

Key image notes Acquisition modality None

Portable data for imaging Acquisition modality None

Consistent presentation of images Acquisition modality None

Consistent time Acquisition modality None

Internet address for InfiMed IHE information: http://www.infimed.com

Links to standards conformance statement for the implementation

DICOM http://infimed.com/customercare/documentation

http:///infimed.com/impdf/DICOM_Conformance.pdf/

Links to general information on IHE

North America:

http://www.ihe.net

Europe:

http://www/oje-europe.org

Japan:

http://www.jira-net.or.jp/ihe-j


A.


APPENDIX B Installation Report

Required. InfiMed requires submission of an installation report within 30 days of first clinical use of the i5 system. Copy the form from the following pages, or use InfiMed's website. On the website, use username generator and password Generation5, and go to http://infimed.com/assets/care_files/documentation/726-105-G1.pdf.

Contact InfiMed Customer Care at +1 315-453-4543 with questions. Thank you.

Installation Report, InfiMed i5 Platform

Service technician: Complete this form to document your installation of the InfiMed i5 Platform. Return this form to InfiMed (121 Metropolitan Dr., Liverpool, NY 13088 USA) within 30 days of

installation. Enter NA if an item is not applicable.

Installation: ___New ___Reinstalled ___Used Date: ___ / ___ / 20___

System serial number:

Site information Distributor information

Name Name

Street Street

City, State, Zip City, State, Zip

Department administrator Service engineer

Phone Phone

Email Email


B.

Survey completed by (print)

Signed Date

Room configuration

Bucky replacement _____ Chest stand _____ Table

Positioner type Make Model

High resolution monitor type Make Model

Control station in: _____ Exam area _____ Control area

Are all interface cables clearly labeled? _____ Yes _____ No

Distance from i5 tower PC to patient area _____

Modem telephone number (if any)

Detector setup

Detector manufacturer & model Wireless _____ Yes _____ No

Mfr & model of second panel, if any: Wireless _____ Yes _____ No

X-ray generator

Manufacturer Model

Integrated with i5 Platform _____ Yes _____ No

Installation notes


B.

Acceptance Tests, InfiMed i5 Platform

Service technician: After completion of each test or procedure, note date that test was completed as well as the results of test or any other pertinent information. Some items listed are optional

equipment and may not have been installed.Enter NA if an item is not applicable.

Procedure Pass Fail NA

Baseline data on previously installed digital system

System diagnostics

System power up sequence

System configuration complete

System panel calibration complete. Document image quality parameters including noise, resolution, uniformity, and signal range.

Ion chamber calibration

Image acquisition

Review of acquired images - W/L/I, AIE, flip, rotate, manual shutter, annotation, pointers, measurements

Print images on DICOM printer

Export patient / image via DICOM network or disc media

Dicom worklist

Import patient from DICOM media

DICOM transfer received

Review or Work Procedures defined in the i5 Platform

Review of Exams defined in the i5 Platform

Review of Positions defined in the i5 Platform

For QA use only

System serial number Installation date

Were any parts damaged in shipment? _____ Yes _____ No

If Yes, record all components that were removed or replaced.

Comments


B.

Removed component Replacement component

Part name IPN Serial no. Part name IPN Serial no.


B.


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