OrthoScan HD Model 1000 Service Manual Rev A Nov 2010

SERVICE MANUAL

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OrthoScan-HD Model 1000-0004 Mini C-arm Imaging System

Service Manual

8212 East Evans Road Scottsdale, AZ 85260

Phone: 480-503-8010 fax: 480-503-8011 [email protected] www.orthoscan.com

OrthoScan Service Department in the U.S. call toll free: +1-866-996-0472

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PROPRIETARY AND CONFIDENTIAL – The information contained in this document is the sole property of OrthoScan, Inc. Any reproduction in part or as a whole without the express written permission of OrthoScan, Inc. is prohibited.

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TABLE OF CONTENTS Introduction... 1 Product Specifications and Components ... 2 ORTHOSCAN HD PRODUCT SPECIFICATIONS ... 2-1

OrthoScan Major Components ... 2-2 FLEX ARM COMPONENTS AND BACK PANEL CONNECTIONS ... 2-3

Electronic Chassis Components ... 2-4

Removal/Replacement Instructions... 3 EM Plate Removal ... 3-1 Electronic Chassis Removal ... 3-2 Video CCA Removal ... 3-3 Monitor Keyboard Assembly Removal... 3-4 X-Ray Light Replacement ... 3-5 Monitor Arm Removal ... 3-6 Monitor Arm Tension Adjustment ... 3-7 Monitor Removal ... 3-8 Printer Removal ... 3-9

System Set-Up ... 4 DICOM Setup ... 4-1 Storage Provider Setup ... 4-2 Worklist Provider Setup ... 4-3 DICOM Print Provider Setup ... 4-4

Image Calibration ... 5 Appendix A ... 5-1 Procedure ... 5-2 Preparation of Collimator ... 5-3 Iris Adjustment ... 5-4 Camera Adjustment... 5-5 Completion of Collimator ... 5-6 Collimator Alignment ... 5-7

System QC Documentation ... 6 Radiation QC Document ... 6-1 Collimation Template ... 6-2 Schematics ... 6-3

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1 Introduction Purpose This service manual provides service information for major components and sub-assemblies of the OrthoScan- HD Model 1000-0004 mini c-arm imaging system.

Scope This document and the diagrams and schematics contained herein are written for technical personnel, such as biomedical engineers. This version of the service manual is intended for use on machines manufactured after May 2008, or on machines prior to this date which have been updated to the OS1005 system.

Precautions Repair, maintenance, calibration or other types of service must always be carried out by suitably qualified personnel. OrthoScan can provide service directly. Service by unauthorized service personnel will void any remaining warranty.

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2 PRODUCT SPECIFICATIONS AND COMPONENTS 2.1 OrthoScan-HD 1000 Product Specifications NOTE: Product design and specifications are subject to change without notice. Equipment Classification

Class 1 Device

Water ingress protection classification

Ordinary Equipment

Mode of operation

Continuous Operation

Electric shock protection classification

Type B applied part

POWER REQUIREMENTS Nominal rated line voltage

100 / 120 / 230 V~ (autosensing)

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~ 120 V~: Bel Fuse 5ET 4 or Littlefuse 0213 0004(P) 230 V~: Bel Fuse 5ET 2 or Littlefuse 0213 0002(P)

Mains Fuses 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 collimation of 10 cm (4 in) or 15 cm (6 in)

Rated peak tube potential

80 kVp

Tube kVp range

40 to 75 kVp

Tube current range

40 to 100 µA (0.04 to 0.100 mA)

Deviation from indicated values

kV + 7%, µA + 10%

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ENVIRONMENTAL SPECIFICATIONS Storage Conditions

Temperature Range 0˚C to 55˚C (32˚F to 131˚F) 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 Intensifier

High sensitivity Cesium Iodide

Image processing

Digital

Monitor

Diagonal viewing size monochrome LCD

Video System

1k by 1k CCD video camera

Video Output Signal

HDMI / VGA

WEIGHTS AND DIMENSIONS Source to Intensifier Distance (SID)

45 cm (17.72 in)

Source to Skin Distance (SSD)

10 cm (3.94 in)

C-arm Free Space

35 cm (13.7 in)

C-arm Depth of Arc

46 cm (18.2 in)

Height

147 cm (58 in)

Width

78 cm (30.5 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)

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. PROPRIETARY AND CONFIDENTIAL 050-0010 Rev. A Page 8 of 55

2.2 OrthoScan Major Components The major components of the OrthoScan-HD 1000 mini c-arm imaging system are shown below:

A

X-Ray Source Assembly

I

Power Switch

B

Image Intensifier

J

Printer (Optional)

C

Collimator

K

Retractable Power Cable

D

Orbital Lock

L

Back Panel Connections

E

Flex Arm

M

Brake

F

Keyboard

N

Cabinet

G

X-Ray On Light

O

Laser Aperture

H

Flat-Screen Monitor

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

Wrist Forearm

Elbow Shoulder

Back Panel Connections

A B C D

Ground Probe Ethernet Port for PACS VGA Output Fuses

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2.4 Electronic Chassis Components Front- with cord reel removed

B

A

Front- with Video CCA removed

B

B

C E D

A- Video CCA (915-0013-01) B- Cooling Fans (920-0078) C- Wireless footswitch CCA (240-0054)- if equipped D- EMI filter (230-0013) E- Power control board (910-0009)

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Rear

Completed electrical chassis

H

G

F

F- Torroid isolation transformer (230-0011) G- Powerbox power supply (260-0026) H- Meanwell power supply (260-0031)

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3 REMOVAL/REPLACEMENT INSTRUCTIONS 3.1 EMI Plate Removal Tools needed: (1) Ratchet w/ 10mm socket (1) ¼” nut driver (1) Small Phillips screwdriver (1) Large Phillips screwdriver (1) Nut Driver Remove back panel by loosening the 4 spring loaded screws Remove Monitor connections as depicted below.

Power Switch

USB Panel Mount

USB to Monitor Hub

Monitor Power

HDMI

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Remove EMI shield by loosening 2 self tapping screws (401-0940) using the 10mm ratchet 8.

Disconnect HDMI cable from pass through on EMI plate

HDMI pass through

Disconnect 4-position power switch receptacle connector

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Power Switch Receptacle Connector

Disconnect 2-pos monitor power connection

Monitor Power Receptacle Connector

Disconnect three USB cables from “J31” location on Video CCA to the three USB

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3 USB connections

Feed thru Couplers on the bottom side of the EMI shield

Disconnect the three printer power cables from the 920-0063 cable to the 250-0058 Black Outlet Connector. *Brown - live, blue - negative, & green / yellow – ground

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Printer Power Supply Connector

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

X-Ray Light Connector

At this point the EMI plate can be completely removed and set aside.

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3.2 Removing Electrical Chassis Tools: (1) Ratchet w/ 10mm socket (1) ¼” nut driver (1) Small Phillips screwdriver (1) Large Phillips screwdriver (1) 10mm Nut Driver (1) 7/16 open end wrench Before removing the electrical chassis first remove the EMI plate as described in section xx.x Once EMI plate has been removed remove fuse box and disconnect all of the cables from the fuse box.

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With fuse box removed check to see if unit is equipped with a wireless receiver. If present disconnect the wireless footswitch sensor cable.

Wireless footswitch sensor cable

Next disconnect all umbilical cable connections Ground wires-

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Camera cable-

HVPS Signal cables and HVPS power connection

Disconnect VGA from “J2” on top of video CCA

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