DRX-Revolution Nano Mobile X-ray System Hardware Guide Rev D March 2018

All rights reserved. No part of this manual may be reproduced or copied in any form by any means-graphic, electronic, or mechanical, including photocopying, typing, or information retrieval systems-without written permission.

Contents

1 Overview ... 1-1

Preface ... 1-1 About this Guide ... 1-1 Related Documentation ... 1-2 Intended Audience ... 1-2 Indications for Use ... 1-2 Usability ... 1-2 Training ... 1-2 Safe Operation Precautions... 1-3 Safety and Warning Symbols ... 1-3

2 Product Description ... 2-1

Features and Functions... 2-1

3 Operation and Use ... 3-1

Operation and Use ... 3-1 Cart... 3-2 Cart Maneuverability and Positioning ... 3-4 Environmental Requirements and Infection Control ... 3-6 Acoustic Noise Emission ... 3-6 Product Classification per IEC 60601-1 ... 3-6 Arm and Tube Head Assembly ... 3-7 Exposure Factors and the X-ray Tube ... 3-13 Time Cycle between Exposures ... 3-15 Component Descriptions ... 3-16

4 Operating the System... 4-1

Drive the Cart... 4-1 Dock and Deploy the Arm ... 4-2 Operating the Machine ... 4-2 Power Button Operation ... 4-3

5 Maintenance and Safety Information ... 5-1 Cleaning Instructions ... 5-1 With Each Occurrence of Patient Contact ... 5-1 Cleaning the Monitor ... 5-2 Cleaning the Hardware ... 5-3 Cleaning the Detector ... 5-4 Cleaning the Plastic Components... 5-4 Cleaning the Arm ... 5-5 System Maintenance... 5-5

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Reporting Unusual Conditions ... 5-6 Replacing the Batteries... 5-6 General Safety Information... 5-7

6 Technical Specifications ... 6-1 7 Troubleshooting... 7-1 Service and Support ... 7-2 Device Identification... 7-2 Procedure for Firmware Upgrade ... 7-2

8 Appendix A... 8-1

Optional Parts ... 8-1

Publication History ...

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Overview

Preface The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including consequential or special damages, resulting from any use of this information, even if loss or damage is caused by Carestream Health’s negligence or other fault.

About this Guide Note The original documentation is written in English. This manual uses three types of messages to emphasize information or potential risks to personnel or equipment: Note, Important and Caution. Note Notes provide additional information, such as expanded explanations, hints, or reminders. Important Important highlights critical policy information that affects how you use this manual and this product. Caution Cautions point out procedures that you must follow precisely to avoid injury to yourself, others, damage to the System or any of its components, loss of data, or corruption of files in software applications. Disregarding the caution statement may lead to abnormal use.

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Overview

Related Documentation •

DRX-Revolution Nano Mobile X-ray System Safety and Regulatory Information

•

DirectView Online Help Topics and DirectView Software User Release Notes

•

DRX-Revolution Nano Mobile X-ray System User Release Notes

•

DRX-Revolution Nano Mobile X-ray System Installation Guide

•

DRX-Revolution Nano Mobile X-ray System Preventative Maintenance Guide

•

DRX-Revolution Nano Mobile X-ray System Site Specification Guide

•

User Guide for Remote Exposure Switches for Mobile X-ray Systems

Intended Audience The audience for this guide includes technologists, radiologists, service engineers, and quality assurance technicians.

Indications for Use The device is designed to perform radiographic X-ray examinations on pediatric and adult patients, in all treatment areas. Mammography examinations are excluded.

Usability The design and development of this diagnostic X-ray system incorporated a usability engineering process in accordance with IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: General requirements for safety. Collateral Standard: Usability

Training This equipment is intended for use by appropriately educated and skilled radiological health care professionals who have received specific training on the operation and use of this equipment. Caution Only qualified, trained X-ray personnel should operate the System. Operation of the equipment by persons who have not been trained or who are unfamiliar with the functions and controls of the System may cause serious injury to the patient, serious injury to the operator, or equipment damage. Caution Federal law restricts this device to sale by or on the order of a physician.

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Overview

Safe Operation Precautions Personnel operating and maintaining this equipment should be familiar with all aspects of operation and maintenance. To ensure safety, read the DRX-Revolution Nano Mobile X-ray System Safety and Regulatory Information carefully before using the system and observe all Cautions, Importants, and Notes located throughout the manual. Important For continued safe use of this equipment, follow the instructions contained in this operating manual. Important Study this manual carefully before using the equipment and keep it at hand for quick reference. The equipment must be used only by qualified personnel and only after training in the specific operations. It is the operator's responsibility to ensure the patient's safety by visual observation, audio communication, proper patient positioning, and use of the protective devices. Thoroughly check that there is no interference or possibility of collision between the patient and other equipment. Maintain the equipment periodically to ensure continued safe use of the equipment. See “Chapter 5 Maintenance and Safety Information” for periodic maintenance recommendations. The equipment must be installed and repaired only by authorized service personnel. For more information, see: DRX-Revolution Nano Mobile X-ray System Safety and Regulatory Information, DRX-Revolution Nano Mobile X-ray System Installation Guide, DRX-Revolution Nano Mobile X-ray System Preventative Maintenance Guide, and DRX-Revolution Nano Mobile X-ray System Site Specification Guide.

Safety and Warning Symbols For symbols that may be used for marking on this equipment, see DRX-Revolution Nano Mobile X-ray System Safety and Regulatory Information.

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Product Description The DRX-Revolution Nano Mobile X-ray System is designed specifically for Digital Radiography (DR) with Carestream-supported detectors (see Section 2.1.10). The DRXRevolution Nano Mobile X-ray System incorporates the tools required for acquiring medical diagnostic images outside of a standard X-ray room. The DRX-Revolution Nano Mobile X-ray System is an all-inclusive mobile X-ray system, providing: •

A high power generator (maximum 5.3 kW @ 100 msec and 7.7 kW @ 13 msec).

•

A user-friendly X-ray tube head, enabling positioning in five axes of motion.

•

A low-profile, ultra-lightweight arm assembly for ease of patient positioning and better visibility while driving.

•

Safe storage for detectors and supplies.

•

Carestream's proven user interface and image editing and processing tools.

Features and Functions The DRX-Revolution Nano Mobile X-ray System is an ultra-lightweight mobile X-ray system providing multiple features and functions.

Image Capture The system provides: •

Easy maneuverability

•

Five axes of motion of the tube head

The tube has a nominal IEC focal spot size range of 0.9 to 1.9 equivalent at 0.1 increments. The generator provides: •

Maximum 5.3 kW @ 100 msec and 7.7 kW @ 13 msec of power

•

40 – 110 kV

•

0.2 – 20.0 mAs

•

30 – 80 mA

Normal operation of the system is considered to be 60 exposures in a 24-hour period.

Power The system operates on a bank of internal rechargeable batteries mounted in an easilyremovable tray, as the system is designed to be used independently of a mains power

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Product Description

source. The battery drawer is field-removable with the use of a tool. Only trained service personnel are to remove the battery tray The battery life allows for taking up to 40 exposures without charging. This assumes fully-charged batteries and various techniques. Note In order to ensure that the cart is always ready to take images, it should be placed on charge whenever it is not in use. Note Shutting down the system using the power button conserves system batteries.

Mobility The low profile arm allows for: •

Visibility while driving.

•

Access to confined spaces.

•

The transport system is designed for movement and maneuverability. It can be driven on surfaces typical to hospital environments at safe walking speed (around 1.5 m/s) with the tube head docked.

Caution The system should not be operated at speeds above safe walking speed (around 1.5 m/s). The brakes are electronically released by the brake release buttons integrated in the handles. In case of no power, a lever situated near the kickplate allows for manually disengaging the brakes. An “inch” feature allows the position of the system to be adjusted while the tube head is deployed.

Main Battery Charging The main battery bank is designed to charge from a normal domestic power supply, i.e., 100 – 240 V, 50/60 Hz, 11– 5.5 A mains power supply. Charge time to fully charge a battery tray is typically less than two hours and at most four hours. Battery charging status is indicated via an LED array on the monitor assembly frame.

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Product Description

Charge level LEDs Battery symbol LED Mains supply plugged LED

Charging LED Behavior Charge Level

LED Bar Behavior

Battery Symbol LED

Mains Supply Plugged LED

<20%

Bar 1 FLASH

OFF

ON

[20% – 35%)

Bar 1 ON, Bar 2 FLASH

OFF

ON

[35% – 50%)

Bar 1,2 ON, Bar 3 FLASH

OFF

ON

[50% – 65%)

Bar 1-3 ON, Bar 4 FLASH

OFF

ON

[65% – 80%)

Bar 1-4 ON, Bar 5 FLASH

OFF

ON

[80% – 95%)

Bar 1,5 ON, Bar 6 FLASH

OFF

ON

[95% – 100%)

Bar 1,6 ON, Bar 7 FLASH

OFF

ON

100%

Bar 1-7 ON

OFF

ON

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Product Description

Discharging LED Behavior Charge Level

LED Bar Behavior

Battery Symbol LED

[95% – 100%) Bar 1-7 ON

ON

[80% – 95%)

Bar 1-6 ON

ON

[65% – 80%)

Bar 1-5 ON

ON

[50% – 65%)

Bar 1-4 ON

ON

[35% – 50%)

Bar 1-3 ON

ON

[20% – 35%)

Bar 1-2 ON

ON

[12% – 20%)

Bar 1 ON

FLASH

[10% – 12%)

Bar 1 ON

FLASH

<10%

All Bars OFF

FLASH

The cart will provide a warning when the batteries have nearly depleted. Up to three exposures can be made after this alert. Prep/expose light Green indicates Ready Yellow indicates XRay Exposure Cart battery status and mains connected indicator

Detector battery charge indicator

Detector battery charging station

Communications Communications are provided through an Ethernet connection or wireless local area network (WLAN) to:

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•

Hospital network

•

RIS

•

PACS

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Product Description

Operator Interface The system includes: •

Primary touchscreen monitor on the cart – 39.6 cm (15.6 in.).

•

Barcode scanner – this is an option.

•

Proximity card reader that scans a radio frequency identification (RFID) badge to identify the operator for logon security – this is an option.

Diagnostics The system includes diagnostics screens that display the status of sensors, boards, brakes, releases, and other values for: •

Tube head

•

Cart braking

•

Battery status

•

Power control board

•

Interface

•

Temperature

A full Service History File is also logged continuously, for diagnostic and fault finding use.

PC Controller The PC controller includes: •

Microsoft WINDOWS

•

Intel® Core™ i5 or higher

•

Random access memory (RAM): 8 GB.

•

1 x Gigabit ETHERNET port

•

WLAN dual band 802.11 b/g/n

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Product Description

Detector Battery Charging and Storage Bins The system includes: •

Storage and charging for one removable battery of either size (25 x 30 or 35 x 43) – only one battery can charge at a time.

•

Storage bin for detectors, grids, and miscellaneous supplies (disinfectant wipes, gloves, patient requisition forms, etc.).

Detector battery charger Important Only charge Carestream detector batteries in the battery charging area. In order to charge a detector battery, insert it into the charging slot so that the battery connectors are facing downwards.

Battery symbol LED

Spare battery status indicator

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Product Description

Important The system must be plugged into mains power to enable detector battery charging. Shutting down the system using the power button disables detector battery charging. Detector Battery Charging LED Behavior Charge Level

Charging

LED Bar Behavior

<20%

No

No bars on

<20%

Yes

First bar flashing

[20% – 40%)

No

First bar on

[20% – 40%)

Yes

First bar on, second bar flashing

[40% – 60%)

No

First two bars on

[40% – 60%)

Yes

First two bars on, third bar flashing

[60% – 80%)

No

First three bars on

[60% – 80%)

Yes

First three bars on, fourth bar flashing

1

[80% – 100% )

No

First four bars on

[80% – 100%1)

Yes

First four bars on, fifth bar flashing

100%

N/A

All bars on

1. Wipes storage 2. Wired exposure switch 3. Detector and grid storage 4. IR remote 5. Detector contamination control bags

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Product Description

Supported Detectors •

CARESTREAM DRX-1 System Detector

•

CARESTREAM DRX-1C System Detector

•

DRX Plus 3543 Detector, DRX Plus 3543C Detector, DRX Plus 4343 Detector and DRX Plus 4343C Detector

•

DRX Core 3543 Detector, DRX Core 3543C Detector, DRX Core 4343 Detector, and DRX Core 4343C Detector

•

DRX 2530C

Flat Panel Detectors (FPDs) can only be paired to one cart at a time as long as Carestream-nominated procedures are followed. Refer to the instructions for use for the particular detector being utilized.

Accessories •

Dose Area Product Meter

•

Wired Exposure Switch

•

Wireless infrared remote exposure switch – allowing the user to expose the patient from up to 10 meters away

•

DRX Tether Cable

•

RFID Proximity Badge Reader

•

Pediatric Filter

Caution Please refer to instructions for use of the wireless infrared remote exposure switch. Caution Please refer to the individual specific manuals of the optional accessories for their instructions for use.

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Operation and Use Caution Do not use the system in proximity to uncontrolled volumes of liquid, spills, etc.

Operation and Use While most of the components will be intuitive to an experienced radiographer, please review the parts diagrams in this document so you become familiar with the naming conventions used by Carestream Health, which are standardized throughout all of the documentation.

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Operation and Use

Cart

1. Detector battery charging and storage module 2. Detector storage bins 3. Collimator handles (“tusks”) and collimator light button 4. Barcode reader 5. Storage for lead markers, papers, tape, paperclips and gloves 6. Touchscreen assembly

7. Arm docking receiver 8. Docking release button and inch feature nudge buttons 9. Cart handles and brake release buttons

With the arm docked, the DRX-Revolution Nano Mobile X-ray System has dimensions of 1276 mm height x 583 mm width x 1371 mm length. Undocked, the arm has a reach of 2123 mm, with an axial reach of 758 mm.

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Operation and Use

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Operation and Use

Cart Maneuverability and Positioning The extreme lightweight design of the DRX-Revolution Nano Mobile X-ray System makes it simple and easy to position and treat patients at the bedside. “Deadman” brakes, released via a streamlined switch on each cart handle, mean the cart is always braked unless the user pushes on the cart handles.

Streamlined “deadman” brake buttons on cart handles

There is also a brake release switch (“inch” feature) on the head handle, which allows the user to disengage braking to make fine positioning changes of the cart while the head is deployed.

Press buttons on the head handle to use the “inch” feature.

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Operation and Use

Caution Check for potential obstacles prior to moving the cart using the “inch” feature. Brakes can be released manually to allow the cart to be moved in cases of lower battery power. The manual release lever is located directly above the kickplate.

1. Rear wheels 2. Brake release buttons 3. Drive handles 4. Manual brake release lever

Caution The manual release for the brakes are to be used only in case of low battery power and then only to move the cart to a position to be charged where the brakes are to be engaged again. If the brakes are not functioning for any other reason, discontinue using the cart immediately and contact your authorized service representative. The cart is designed to negotiate obstructions up to 50 mm in height. In order to negotiate an obstruction, tilt the cart back onto its rear wheels by bracing the cart with your foot on the kickplate while pulling back on the drive handles, and then push the cart over the obstruction.

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