OrthoScan-HD Flat Detector Service Manual

TABLE OF CONTENTS Introduction ... 1 Product Specifications and Components ... 2 ORTHOSCAN HD FLAT DETECTOR PRODUCT SPECIFICATIONS ... 2.1 ORTHOSCAN MAJOR COMPONENTS ... 2.2 FLEX ARM COMPONENTS AND FOCAL SPOT LOCATION DIAGRAM ... 2.3 ELECTRONIC CHASSIS COMPONENTS ... 2.4

Removal/Replacement Instructions... 3 EMI PLATE REMOVAL ... 3.1 ELECTRICAL CHASSIS REMOVAL ... 3.2 VIDEO CCA REMOVAL ... 3.3 MONITOR KEYBOARD ASSEMBLY, REMOVAL AND ADJUSTMENT ... 3.4 MONITOR ARM REMOVAL AND ADJUSTMENT ... 3.5 PRINTER REMOVAL ... 3.6 INFRARED FOOTSWITCH CONNECTIONS AND INFORMATION ... 3.7 X-RAY TUBE (HVPS) ... 3.8 COLLIMATOR ALIGNMENT ... 3.9 GENERATOR TESTING ... 3.10 FLAT DETECTOR REPLACEMENT AND COVER REMOVAL ... 3.11 FLAT DETECTOR POWER SUPPLY ... 3.12 SYSTEM SETTINGS AND CALIBRATIONS ... 3.13 FLEX ARM TENSION ADJUSTMENTS ... 3.14 Laser Alignment ... 3.15

System Set-Up ... 4 DICOM SETUP ... 4.1 STORAGE PROVIDER SETUP ... 4.2 WORKLIST PROVIDER SETUP ... 4.3 DICOM PRINT PROVIDER SETUP... 4.4

System QC Documentation ... 5 RADIATION QC DOCUMENT... 5.1 RADIATION QC PROCEDURE ... 5.2

PROPRIETARY AND CONFIDENTIAL

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1 Introduction

Purpose This service manual provides service information for various major components and sub-assemblies of the OrthoScan-HD Flat Detector mini c-arm imaging system.

Scope This document, diagrams, and schematics contained herein are written for technical personnel, such as biomedical engineers.

Precautions Repair, maintenance, calibration or other types of service should be carried out by suitably qualified personnel. OrthoScan provides service directly. Service by unauthorized service personnel will VOID any remaining warranty.

ELECTROMAGNETIC COMPATIBILITY This equipment generates and uses radio frequency energy and, if not installed and used in strict accordance with the manufacturer’s instructions, may cause or receive interference. If this equipment seems to cause or receive interference when turned on (which may be determined by turning equipment off and on), try to correct the interference by one or more of the following steps: relocate the equipment with respect to other equipment in the room, or plug the system into a different outlet so that the circuit is not shared with the other equipment, or use other measures, as required. Call the phone number listed on the cover of this manual if you have questions concerning electrical power for the system. Changes or modifications to this equipment not expressly approved by the agency responsible for compliance could void the authority of the owner/user to operate the equipment. If any modification is made, the owner/user is responsible for compliance of the equipment.

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2 Product Specifications and Components

2.1 OrthoScan-HD Flat Detector Product Specifications NOTE: Product design and specifications are subject to change without notice. DEVICE CLASSIFICATIONS Equipment Classification (IEC 60601)

Class 1 Device

Water ingress protection classification

Ordinary Equipment

Mode of operation

Continuous Operation

Electric shock protection classification

Type B applied part Not suitable for use with flammable anesthetics

HD Mini C-arm X-ray System

Class II (FDA) / Class IIb (EU) / Class III (Canada)

POWER REQUIREMENTS Nominal rated line voltage

100 / 120 / 230 V~ (factory preset)

Frequency

50 Hz or 60 Hz

Line voltage regulation

+ 10% daily line reg.

Current

< 4A at 120 V~, ≤5A at 100 V~, ≤2A at 230 V~ 100 V~: Bel Fuse 5ET 5 or Littelfuse 0213 0005(P) 120 V~: Bel Fuse 5ET 4 or Littlefuse 0213 0004(P) 230 V~: Bel Fuse 5ET 2 or Littlefuse 0213 0002(P)

Mains Fuses LASER SPECIFICATION Laser Classification

Class 2 (IEC 60825-1)

Max Power Output

3.5mWatts

Wavelength

635 nm

X-RAY SPECIFICATIONS Duty cycle at 75 kVp / 0.1mA

Continuous duty

X-ray source

Superior SXR-80

X-ray tube window

0.75 mm Beryllium

Beam filtration

2.5 mm Aluminum equivalent

Focal spot

50 microns

Field of view

Operator selectable 11cm x 8cm (Magnification Mode) or 15cm x 12cm (Normal Mode)

Rated peak tube potential

80 kVp

Tube kVp range

40kVp to 75kVp (Boost Mode: 40kVp to 78kVp)

Tube current range

40 to 100 µA (Boost Mode: 40µA to 160µA)

Deviation from indicated values

kV + 7%, µA + 10%

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2 Product Specifications and Components ENVIRONMENTAL SPECIFICATIONS Storage Conditions

Temperature Range 32˚F (0˚C) to 131˚F (55˚C) Relative Humidity of >10% to < 100% (no condensation) Atmospheric Pressure of 500hPa to 1060hPa

Operating Temperature (Ambient)

15º to 32ºC (59º to 90ºF)

Operating Humidity (Ambient)

20% – 80% relative humidity, non-condensing

IMAGING SPECIFICATIONS Image Receptor

Complementary Metal Oxide Semiconductor (CMOS) Flat Detector

Image Processing

Digital

Monitor

Diagonal viewing size monochrome LCD

Video System

1.5k by 2k CMOS receptor

Video Output Signal

VGA & DVI

WEIGHTS AND DIMENSIONS Source to Detector Distance (SID)

45 cm (17.72 in)

Source to Skin Distance (SSD)

10 cm (3.94 in)

C-arm Free Space

35 cm (14 in)

C-arm Depth of Arc

49 cm (19.2 in)

Height

147 cm (58 in)

Width

79 cm (31 in)

Weight

180 kg (400 lb)

Shipping Weight

194 kg (430 lb)

Ground Clearance

18 cm (7 in)

Power Cord Length

610 cm (20 ft)

Footprint

79 cm x 101 cm (40 in x 31 in)

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2 Product Specifications and Components

2.2 OrthoScan Major Components The major components of the OrthoScan-HD Flat Detector mini c-arm imaging system are shown below: G

H

I E

A C

F J N K L

B

D

D M

A B C D E F G

X-Ray Source Assembly Flat Detector Collimator Orbital Lock Flex Arm Keyboard X-Ray On Light

H I J K L M N

Flat-Screen Monitor Power Switch Printer (Optional) Retractable Power Cable Back Panel Connections Brake Cabinet

Back Panel Connections A B C D

A

B

C

Ground Probe Ethernet Port for PACS VGA Output Fuses

D

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2 Product Specifications and Components

2.3 Flex Arm Components and Focal Spot Location Diagram Flex arm is comprised of the wrist joint, forearm, elbow joint and shoulder as depicted below.

Wrist

Forearm

Elbow Shoulder

Focal Spot Location Diagram

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2 Product Specifications and Components

2.4 Electronic Chassis Components 915-0013-03 Video CCA

A

910-0010-04 Video CCA

A

B

C E

B

A- Video CCA B- Solid state hard drive (902-0010-20x) C- Wireless footswitch CCA (240-0054) if equipped D- EMI filter (230-0013) E- Power control board (910-0009)

D

Common to both Video CCA’s

Chassis Front- with Video CCA removed

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2 Product Specifications and Components

Chassis rear view

Common to both Video CCA’s

I

H

G

F

F- Torroid isolation transformer (230-0011) G- 12v power supply (260-0035) H- 6v power supply (260-0033) I- 5v/24v power supply (260-0032)

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3 Removal/Replacement Instructions

Caution! Ensure unit is unplugged prior to servicing! Service personnel must be properly grounded while working with and around sensitive electrical components.

3.1 EMI Plate Removal Tools needed: Ratchet 3/8” socket 1/4 ” nut driver Small Phillips screwdriver Large Phillips screwdriver Nut Driver 1. Remove back panel by loosening the 4 spring loaded screws 2. Remove Monitor connections as depicted below. (See Section 3.6 for printer removal)

USB Panel Mount

Power Switch

USB to Monitor Hub Monitor Power

HDMI

3. Remove EMI shield by loosening 2 self tapping screws (401-0940) using the 3/8” ratchet

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3 Removal/Replacement Instructions

4. Disconnect HDMI cable from pass through on EMI plate

915-0013-03 Video CCA

OR

HDMI Pass Through

910-0010-04 Video CCA

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3 Removal/Replacement Instructions

5. Disconnect 4-position power switch receptacle connector and 2-pos monitor power connection Monitor Power Pass Through Connector

Common to both Video CCA’s Power Switch Pass Through Connector

6. Disconnect three USB cables from location on Video CCA 3 USB Connections

915-0013-03 Video CCA

910-0010-04 Video CCA

OR

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3 Removal/Replacement Instructions

7. Disconnect the three printer power cables from the 920-0063 cable to the 250-0058 Black Outlet Connector. *Brown = Live Blue = Neutral Grn/Yellow stripe = Ground

Printer Power Supply Connectors

Common to both Video CCA’s

8. Disconnect green & black 2-pos X-Ray light connector from “J2” location on Video CCA

915-0013-03 Video CCA

910-0010-04 Video CCA

OR

9. The EMI plate can be removed and set aside.

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3 Removal/Replacement Instructions

3.2 Electrical Chassis Removal Caution! Ensure unit is unplugged prior to servicing! Service personnel must be properly grounded while working with and around sensitive electrical components.

Tools: Ratchet 10mm socket 3/8” socket 1/4” nut driver Small Phillips head screwdriver Large Phillips head screwdriver 10mm Nut Driver 7/16” open end wrench 1. If possible login to the OrthoScan System Configuration and record all settings in the ‘ABS/Mask Setup’, ‘MagMode Setup’, ‘System Configuration’, ‘Storage Provider Setup’, ‘Worklist Provider Setup’, and ‘Print Provider Setup’ tabs, prior to removing chassis. 2. Remove the EMI plate as described in section 3.1 3. Refer to section 3.13 for masking procedures if installing new chassis. 4. Check to see if unit is equipped with a wireless receiver. If present disconnect the wireless footswitch sensor cable. When reassembling make sure pins are aligned.

Wireless Footswitch Sensor Cable

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3 Removal/Replacement Instructions

5. Disconnect ground wires Ground Wires

Common to both Video CCA’s

6. Remove cord reel with three bolts using a 10mm wrench (white arrows) and swing cord reel out of the way.

Common to both Video CCA’s

7. Remove the four 7/16” nuts that hold the cord reel mount.

Common to both Video CCA’s

* 910-0010-04 board pictured. Procedure is the same for 915-0013-03 board. PROPRIETARY AND CONFIDENTIAL

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3 Removal/Replacement Instructions

7. Disconnect all cable connections indicated in the pictures below.

915-0013-03 Video CCA

Flat Detector Cable

HVPS Power Connection

PROPRIETARY AND CONFIDENTIAL

HVPS Signal Cables

920-0086 Cable Connect to Shutdown

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3 Removal/Replacement Instructions

915-0013-03 Video CCA (continued) Tube Head Fluoro Switch

Wireless Print/Save

Wired Footswitch

Wireless Fluoro

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3 Removal/Replacement Instructions

915-0013-03 Video CCA (continued) DVI Cables

5 position Red Connector

CAT6 Cable

Fan Power Cables

Serial/Tube Head Controls

Flat Detector Power Cable

Proceed to step 8 PROPRIETARY AND CONFIDENTIAL

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3 Removal/Replacement Instructions

910-0010-04 Video CCA

Flat Detector Cable

VGA cable

HVPS Signal Cables

Tube Head Fluoro Switch

Wireless Print/Save Wireless Fluoro

Smart Shutdown Cable Wired Footswitch

PROPRIETARY AND CONFIDENTIAL

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3 Removal/Replacement Instructions

910-0010-04 Video CCA (continued) HVPS Power Connection

Serial/Tube Head Controls

5 position Red Connector Disconnect fan power cables.

CAT6 Connector

PROPRIETARY AND CONFIDENTIAL

Flat Detector Power Cable

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