MinXray HF120-60HPPWV User manual

HF120/60HPPWV PowerPlus

High Frequency Portable X-ray Unit

Installation and Operating Instruction

Version 1.1

This special purpose portable equipment is for diagnostic radiography only.

It is not designed, nor does it meet, the standards for any other use.

Caution:

Federal law restricts this device to sale by or on the order of a

licensed physician.

MinXray, Inc.

3611 Commercial Avenue

Northbrook, Illinois 60062-1822

U.S.A.

Tel. 1-847-564-0323

Toll Free Tel: 1-800-221-2245 (U.S. and Canada)

Fax: 1-847-564-9040

E-mail: service@minxray.com

www.minxray.com

…

TABLE OF CONTENTS

…

Introduction

Certifications

Recordkeeping Requirements

Components

Main Parts

Warning statements, figures and symbols

Installation Instructions

Unpacking

ssembly Instructions Pre-Operational Required Testing Installation Check list

Operating Instructions

Operation Safety Precautions Maintenance

………………………………………………

…………………………………

………………………………… ………………………………… …………………………………

……………………

………… 10

……………………

9 9

15 17 17

Specifications

Schematic Diagram

X-ray Tube

………………………………………………

quip

INTRODUCTION

The MinXray model HF120/60HPPWV PowerPlus unit. The HF120/60HPPWV PowerPlus

can be used with conventional diagnostic film or with solid-state

is a mono-block type high frequency portable x-ray

digital radiographic sensors. It is supplied with the x-ray tubehead/collimator, detachable AC power cord, and detachable exposure cord with 2-stage exposure switch. The MinXray HF120/60HPPWV

PowerPlus

high frequency diagnostic x-ray unit is designed for use with the MinXray model XGS MKIV LW or equivalent stand capable of providing secure, stable support that allows for proper positioning of the x-ray unit for radiographic imaging.

CARELESS OR IMPROPER USE OF X-RAY EQUIPMENT CAN BE EXTREMELY HAZARDOUS. It is imperative that this equipment be operated and serviced only by trained personnel familiar with the safety precautions required to prevent excessive exposure to primary X-ray radiation, the dangers of exposure to X-ray radiation, and the proper use of the equipment discussed in this manual.

All personnel authorized to operate o

service this equipment should be fully acquainted with the established maximum permissible doses, safety recommendations, and procedures derived from the following sources:

National Council on Radiation Protection Report No.33 (Medical X-Ray and Gamma Ray Protection for Energies up to 10 MEV - Equipment Design and Use); from NRCP Publications;

P.O. Box 30175, Washington, D.C. 20014.

National Bureau of Standards Handbook No.76 (Medical X-Ray Protection up to Three Million Volts); from the Superintendent of Documents, Government Printing Office, Washington, D.C.

20401.

All documents relating to the Performance Standard fo Subchapter J, Part 1020; obtainable from FDA Center for Devices and Radiological Health,

Diagnostic X-Ray Systems, 21 CFR

Department of HHS, 2098 Gaither Road, Rockville, MD 20850.

State and local regulations governing radiation protection and the use of diagnostic X-ray e

ment.

Requirements of the user’s in-house radiation protection program.

Instructions and precautionary notices of this manual.

Although this equipment incorporates protective design features for limiting both the direct (primary) x-ray beam and the secondary radiation produced by this beam, design factors alone cannot prevent human carelessness, negligence, or lack of knowledge. This apparatus is sold with the understanding that the user assumes sole

responsibility for radiation safety and that MinXray, Inc., its

agents and representatives and do not accept responsibility for:

Injury or danger to patient or other personnel from x-ray exposure.

Overexposure due to poor operating techniques or procedures.

Equipment not properly serviced or maintained in accordance with this manual.

Equipment which has been modified or tampered with in any way.

Equipment that has been connected to input voltage other than the voltage specified

on the rating label affixed to the x-ray unit.

CERTIFICATIONS

THIS PRODUCT CONFORMS TO

ALL APPLICABLE DHHS

RADIATION STANDARDS OF 21

CFR SUBCHAPTER J AS OF THE

DATE OF MANUFACTURE

All

tified

fil

All

quip

RECORD KEEPING REQUIREMENTS

Dealer and Distributor Records

Dealers and distributors of x-ray equipment shall obtain and preserve fora period of five

years from the date of sale, award, or lease of each such product, such information as is necessar

Such information shall include:

1) The name and mailing address of distributor, dealer, or purchaser to whom the product was transferred.

2) Identification and brand name of the product.

3) Model number and serial or other identification number of the product.

4) Date of sale, award or lease.

Records to be furnished to MinXray, Inc. by Dealers and Distributors

The information required in "1" above shall immediately be forwarded to MinXray unless:

to permit tracing of specific products to specific purchasers.

The deale

furnish it to MinXray, Inc. when advised by MinXray or Director, Department of Health and Human Services, that such information is required for purposes of Section 359 of the Radiation Control for Health and Safet

The deale

notifies MinXray and the Center for Devices and Radiological Health of such election. Such notification shall be in writing and shall identify the dealer or distributor and the type of e

ssembler's Report

assemblers whoinstallcer assembler's reports shall be on Form FD-2579, which is prescribed by and available from the Director, FDA/Department of Health and Human Services, Division of Compliance, 1390 Piccard Drive, Rockville, Maryland 20850. The original of Form FD-2579 shall be sent to the Director and copies to the purchaser, State Agency responsible for radiation

rotection, and one kept by the assembler for a period of least 5 years.

ordistributorelects to hold and preserve such information, and to immediately

Act of 1968.

ordistributor, upon making the election under"a" above of this section, promptly

ment for which the information is being accumulated.

componentsshou

e a reportofsuchassembly.

TO: ALL MANUFACTURERS AND ASSEMBLERS OF DIAGNOSTIC X-RAY EQUIPMENT

ibilit

SUBJECT : Final Testin Assembl

This lette x-ray system or component before release to the user.

Manufacturer Responsibility - The FDA believes that plant-based manufacturers must include in their assembly instructions a specific requirement that the assembler perform a test(s) for the applicable requirements of the FDA performance standard at the time of installation. A thorough explanation of the equipment required and step-by-step instructions must be provided by the component or system manufacturer. The instructions should include a requirement to record key data to demonstrate at a later data that all tests were performed and that the equipment was left in full compliance with the standard. The FDA's Department of Health and Human Services will insure that these assembler test instructions are provided through a close review of the information submitted by manufacturers in initial, model change and annual reports. Plant-based manufacturers who do not include a final compliance test in their assembler instructions could be subject to disapproval of their quality control and testing program.

ssemble or tests for the applicable requirements of the FDA performance standard at the time of installation if specified in the assembly instructions provided by the component or system manufacturer. Assemblers who do not perform and document such final compliance tests will be considered by the FDA to have issued a false and misleading certification and will, therefore

is intended to establish HHS policy relative to final testing of a newly-assembled

espons

be subject to regulatory action by the Agency.

of Diagnostic X-ray Systems and Components Followin

y-Assemblers o

agnostic x-ray equipmentmustperform ates

Should they be any questions concerning this Bureau policy please call X-ray Products Branch at 301-594-4591.

)

COMPONENTS

1. X-ray Unit (Model HF120/60HPPWV PowerPlus

2. Power cord

3. Hand-held Exposure Switch and Cord

4. Instruction Manual

OPTIONAL COMPONENTS

Portable stand (Model XGS MKIV LW or equivalent) System Transport Case (Model HF100HSTC) Carrying case (Model HF120/60HCC)

1 set

1 pc.

Collimato

MAIN PARTS OF MinXray HF120/60HPPWV PowerPlus

Low line voltage indicator

ngle indicator

Battery compartment

mA test jack

Exposure switch and cord Power cord

Connector for exposure switch

Connector for power cord

Fuse folder

Main power switch

+ 17 hidden pages

MinXray HF120-60HPPWV User manual

Specifications and Main Features

Frequently Asked Questions

User Manual