Model QT-711-EV Operators Manual Rev D

THE ORIGINAL VERSION OF THIS MANUAL DATED APRIL 30, 2004 HAS BEEN DRAFTED IN THE ENGLISH LANGUAGE BY QUANTUM MEDICAL IMAGING, LLC

This manual is copyrighted and all rights are reserved. No portion of this document may be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine readable form without prior consent in writing from Quantum Medical Imaging, LLC. (QMI)

Copyright© 2006 QMI

Quantum Medical Imaging, LLC 2002-B Orville Drive North Ronkonkoma, New York 11779 USA Phone: (631) 567-5800 Fax: (631) 567-5074 E-mail: info@qmiteam.com www.quantummedical.net

Made in U.S.A.

Revision History

REVISION

DATE

TYPE OF MODIFICATION

A

4/30/04

Initial Release

B

9/3/04

Added UL mark, ECO 1468B, 1516

C

7/12/05

Incorporated ECO 1630

D

2/10/06

Incorporated ECO 1716

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1-1 thru 1-6

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3-1 thru 3-18

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4-1 thru 4-8

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5-1 thru 5-8

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Elevating Mobile Float-Top Radiographic Table - Operator’s Manual Quantum Medical Imaging, LLC

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Elevating Mobile Float-Top Radiographic Table - Operator’s Manual Quantum Medical Imaging, LLC

Table of Contents

Table of Contents Chapter 1, Safety Notices

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Chapter 2, Introduction

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Chapter 3, Operation

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Chapter 4, Useer Maintenance

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Chapter 5, Warranty Information

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Table of Contents

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Chapter

1

SAFETY NOTICES

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Safety Notices

CAUTION! This unit utilizes a low power (1 mW 650 nm) Class II Laser to produce an alignment beam. DO NOT STARE DIRECTLY INTO THE BEAM OR VIEW WITH OPTICAL INSTRUMENTS.

WARNING! Quantum Medical Imaging, LLC disclaims all responsibility from any injury resulting from improper use or application of this equipment. This equipment is designed to be used exclusively under the prescribed direction of a person who is licensed by law to operate equipment of this nature. This equipment must be used in accordance with all safety procedures described in this manual and must not be used for purposes other than those herein described. Quantum Medical Imaging, LLC assumes no responsibility for any malfunctioning of this equipment resulting from the improper operation, maintenance, or repair, nor from damage to or modification of its components. Failure to observe these warnings may result in serious injury.

X-RAY PROTECTION X-rays are hazardous to both patient and operator unless established safe exposure factors and operating instructions are observed. It is important that everyone having anything to do with xradiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from: NCRP Publications, 7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814-3095 (www.ncrp.com), and of the International Commission on Radiological Protection (www.icrp.org), and take adequate steps to protect against injury. X-ray equipment may cause injury if used improperly. The instructions contained in this manual must be read and followed when operating this unit. Personal radiation monitoring and protective devices are available. You are urged to use them to monitor exposure to, and protect against unnecessary exposure to x-ray.

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Safety Notices

REGULATORY COMPLIANCE This certified medical device has been designed, manufactured, and calibrated to comply with governing Federal Regulations 21 CFR Subchapter J and the performance standards attendant thereto. Upon installation, all certified products require the filing of Form FD-2579 "Report of Assembly of a Diagnostic X-ray System" by the assembler (i.e., the installer) with the appropriate agencies; the "Installation Quality Assurance Checklist" must also be completed and properly distributed upon installation. A copy of each form (pink copy) is provided to the user. The installation report is completed by the installer and returned to Quantum Medical Imaging, LLC. Those responsible for the planning of x-ray equipment installations must be thoroughly familiar and comply completely with NCRP Report No. 49, "Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies up to 10 MeV", as revised or replaced in the future. Those authorized to operate, test, participate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures described in publications such as Subchapter J of Title 21 of the Code of Federal Regulations, "Diagnostic X-Ray Systems and Their Major Components," and NCRP Report No. 102, “Medical X-Ray, Electron Beam and Gamma Ray Protection for Energies Up to 50 MeV-Equipment Design and Use” as revised or replaced in the future. Scheduled maintenance is essential to the assurance of continued integrity of this equipment with respect to regulatory compliance. The continuance of certified performance to the regulatory standard is incumbent upon the user's diligent conformance to recommended maintenance instructions. This product has been classified as Type B, Class I internally powered by Underwriters Laboratories, Inc. This equipment is not suitable for use in the presence of a flammable anesthetic mixture of air with oxygen or with nitrous oxide. Protection against Electric Shock (Class I - Type B applied parts); Protection against Harmful Ingress of Water (Ordinary) MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE, MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1 AND CAN/CSA C22.2 NO. 601.1 98UA

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Safety Notices

This product complies with IEC 60601-2-32: Associated Equipment of X-ray Equipment. The following symbols may be used for marking on this equipment or equipment documentation: Earth (ground)

Type B Equipment

Protective Earth (ground)

Attention, consult accompanying documents

APPLICABLE STANDARDS The Model QT-711-EV Elevating Mobile Float-Top Radiographic Table complies with the following regulatory standards: •

FDA Center for Devices and Radiological Health (CDRH) - Title 21 CFR Subchapter J

•

IEC 60601-1, 2nd Edition

•

IEC 60601-2-32: 1994(E)

•

CAN/CSA C22.2 No. 601.1 M90

•

UL 60601-1, 1st Edition

•

IEC 60601-1-2: 2001(E)

•

IEC 60825-1 Edition 1.2, 2001-08

•

This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe A est conforme á la norme NMB-003 du Canada. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pusuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

•

EC Directive 93/42/EEC for Medical Devices

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Safety Notices

EU Authorized Representative: Medizintechnik Berlin GmbH Altentreptower, Strasse 59 12683 Berlin - Germany Phone: +49-302-82 4726 Fax: +49-302-82 6382 E-mail: Medizintechnik.Berlin.GmbH@t-online.de

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Chapter

2

GENERAL INFORMATION

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Chapter 2 - General Information

SYSTEM OVERVIEW

NOTE

This manual provides needed information for operating and maintaining the Model QT-711-EV Elevating Mobile Float-Top Radiographic Table referred to herein as the Radiographic Table. NOTICE! It is imperative that all procedures described in this manual be strictly adhered to, in order to ensure the safety of patients, operators, and service personnel.

The user should read this manual in its entirety prior to using this equipment. It should be kept in a location near the equipment and readily accessible to the those that operate it.

The intended Operator and Servicer of this equipment must read this manual in its entirety prior to use. This Operator’s Manual and the companion QT-711-EV Service Manual must be located adjacent to the equipment, and be kept readily accessible to all those that would operate or service it. INTENDED USE The Radiographic Table is intended for use solely as a patient support device during the performance of general purpose radiographic examinations. KEY FEATURES The key features of this Radiographic Table are as follows: •

Cordless Mobile X-Ray Table with On-board Rechargeable Battery

•

Dual-Motorized Telescopic Lifts for fast, easy patient positioning

•

85” x 28” Examination Table provides a generous platform

•

700 lb. Patient Weight load capacity (evenly distributed)

•

4-Way Floating Tabletop provides precise final positioning, then locks

•

5” Precision Swivel Casters with One-Foot ‘Steer & Lock’ Pedal

•

Twin Lift Column design, perfect for use with Digital Image Receptors

•

Laser and Mechanical Obstruction Sensors guard sensitive components

•

Approximately 100 lifts between charges (depending on patient weight)

•

Sleep Mode insures long idle periods without the need to recharge

•

Heavy-duty charger provides rapid recharge capability

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Chapter 2 - General Information

MAIN COMPONENTS - MODEL QT-711-EV See Figures 1-1 and 1-2 ITEM 1

Patient Hand Grips

2

Floating Tabletop

3

Wheel Lock/Neutral/Steer Pedal

4

Float-Top Lock/Unlock Brake Lever

5

Dual-Motorized 3-Section Telescoping Lift Actuators

6

Emergency Stop Switch

7

Emergency Indicator Red LED

8

Foot Pedal Control Assembly

9

Table-Up Foot Switch

10

Table-Down Foot Switch

11

Programmed Height Switch

12

Programmed Height Indicator Green LED

13

Battery Charge Level Indicator & Error Enunciator

14

Compliance Label

15

Laser Warning Label

16

Laser Emitter and Shutter Hood

17

Laser Sensor

18

Steer/Neutral/Lock Pedal Label

19

Locking/Steering Caster (Right Front Only)

20

Power Input Socket

21

The External Base Charging Power Supply

22

Load Disconnect Switches - Access Cover Plugs

23

Total Lock Caster (1 of 3)

24

SonAlert (error enunciator)

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DESCRIPTION

Elevating Mobile Float-Top Radiographic Table - Operator’s Manual Quantum Medical Imaging, LLC

Chapter 2 - General Information

1

2

21

17 7

5

3

5

16

6 4

15

22

14

8

19

Figure 2-1. Model Q-711-EV Elevating Radiographic Table - Major Components

24 20

13 18 11 12

10

9

23 Figure 2-2. Model QW-420 Vertical Wall Stand (with 14" x 36" Cabinet)

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Chapter 2 - General Information

PHYSICAL SPECIFICATIONS Table Specifications (See Figure 2-3) •

Length

85.0 inches (2159.0 mm) Standard 78.0 inches (1981.2 mm) Minimum*

•

Width

28.0 inches (711.2 mm)

•

Height

22.63 inches (574.8 mm) Minimum 33.63 inches (854.2 mm) Maximum

•

Material Type

Phenolic Fiber Resin

•

Density

Less than 0.95 mm Aluminum

•

Maximum Patient Load

700 lbs. (317.5 Kg), evenly distributed

•

Gross Table Weight

385 lbs. (174.6 kg)

PERFORMANCE SPECIFICATIONS Table Top Travel Specifications •

Longitudinal Travel**

14.0 inches (355.6 mm) Maximum 7.0 inches (177.8 mm) Minimum

•

Transverse Travel**

4.12 inches (104.8 mm)

•

Vertical Travel

11.0 inches (279.4 mm)

•

Vertical Travel Speed

~1.0 inch per second (25.4 mm/sec.)

CHARGER & TABLE ELECTRICAL SPECIFICATIONS •

Charger Dimensions

15.0 x 12.5 x 6.25 inches

•

Height x Width x Length

381.0 x 317.5 x 158.75 mm

•

Charger Input Power Switch selectable for

115 VAC / 1.15 A 50/60 Hz 230 VAC / 0.75 A 50/60 Hz

•

Charger Output & Cord

29 VDC / 6A 30 Feet (9.15 Meters)

•

Table Input Power

29 VDC / 4.0A

•

Battery Type

Internal Sealed Lead-Acid Gel Cells

•

Battery Capacity Provides

10 Ampere-Hours @ 24 VDC 100 Lift Cycles (minimum)

•

Battery Charge Time

3.5 Hours (maximum)

•

Duty Cycle

40 up/down cycles/hr

* Note: Available reduced-length tabletops reduce longitudinal travel by one inch for each one inch of reduced table length. ** Note: Longitudinal/transverse travel divides equally about the table center.

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Chapter 2 - General Information

85.00

28.25

1.84

85.00

TABLE TRAVEL

7.00

LOW= 14.25 HIGH= 25.50

22.50 @ RETRACTED POSITION (SHOWN) 33.75 @ EXTENDED POSITION (11.25 TRAVEL) .38

37.00

NOTES: 1. TABLE WEIGHT (NO LOAD): 385 LBS.

Figure 2-3. Model Q-711-EV Elevating Radiographic Table Dimensions ENVIRONMENTAL SPECIFICATIONS System Operating Environment •

Ambient Temperature:

+10° to +40° Centigrade +50° to +104° Fahrenheit

•

Relative Humidity:

20% to 80% Non-condensing

•

Altitude: Relative to Sea Level

-30.5 to +2440 Meters -100 to +8000 Feet

Non-Operating Environment •

Ambient Temperature:

-18° to +65°Centigrade +0° to +149°Fahrenheit

•

Relative Humidity:

20% to 95% Non-condensing

•

Altitude: Relative to Sea Level

-30.5 to +3048 Meters -100 to +10000 Feet

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Chapter 2 - General Information

COMPATIBILITY STATEMENT The Model QT-711-EV Table is fully compatible with all QMI Tubestands, Wallstands, and High Frequency X-ray Generators; and is suitable for use with other manufacturers’ equipment which incorporate equivalent means of SID indication and perpendicularity.

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Chapter

3

OPERATION

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Chapter 3 Operation

RADIOGRAPHIC TABLE OPERATION

NOTE

When using the QT-711-EV Float-Top Table in conjunction with the QMI Model QW-420T or QW-420-TD Wall Stand: Always adjust the Image Receptor’s height to the TABLE Position and tilt the Image Receptor to the 90° Position before moving the Float-Top Table over the Image Receptor. Please refer to the QMI Model QW-420-T or QW-420-T-D Installation and Operation Manuals.

CAUTION! All movable components of this equipment must be operated with reasonable care. To ensure maximum effectiveness of the wheel locks, the Radiographic Table must only be operated on a smooth level floor. WARNING! Patient loads placed upon the table must be distributed as evenly as possible over the table top’s support surface. Never seat a patient at the extreme ends of the table when the tabletop is not centered. Patients should always be transferred to or from the table at the front side and only at the center. Please see Figure 3-1 below. Use care to keep the patient’s feet away from the Wheel Lock Pedal and the Foot Control Pedal when moving the patient on or off the table. Prior to transferring a patient, make certain the Tabletop Float Lock is fully engaged and the Wheel Lock Pedal is in the Locked position. Do not raise or lower table with patient in seated position on the table top; patient should be in prone or supine position (i.e., horizontal) during motion. QMI requires strict observance of these basic, sensible procedures to prevent damage to the Float-Top System and to assure patient and operator safety.

OPERATIONAL OVERVIEW This chapter describes the proper use of the Radiographic Table System. The Radiographic Table is delivered fully assembled, along with one or more companion Base Charging Power Supplies, which must be permanently wall-mounted in the general vicinity of the table.

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