Ziehm Solo Technical Manual May 2010

Contents

6.2.5 Discarding the operation settings ... Basic settings ... 6.3.1 Setting the system date and the system time... 6.3.2 Selecting the live screen ... 6.3.3 Entering the hospital data ... 6.3.4 Discarding the basic settings... Cine/DSA/Dose (for Germany - Cine/SUB/Dose)... 6.4.1 Cine loop settings... 6.4.2 Showing or hiding the native image ... 6.4.3 Discarding the cine loop and subtraction mode settings ... Storage media ... 6.5.1 Defining the USB stick storage format ... 6.5.2 Defining the CD/DVD storage format ... 6.5.3 Deleting data from storage media ... Setting the 24" flat-screen monitor ... 6.6.1 Overview ... 6.6.2 Setting the brightness, contrast and backlight... 6.6.3 Setting the menu language ... 6.6.4 Restoring the factory settings... Setting the 18" flat-screen monitors... 6.7.1 Flat-screen monitors of type 1... 6.7.2 Flat-screen monitors of type 2...

6-6 6-7 6-8 6-8 6-9 6-10 6-11 6-12 6-13 6-14 6-15 6-16 6-17 6-18 6-19 6-19 6-20 6-22 6-23 6-24 6-25 6-33

7

Technical Data 7.1 General technical data... 7.1.1 Systems with a voltage rating of 100 V, 120 V, 200 V ... 7.1.2 Systems with a voltage rating of 220 V, 230 V, 240 V ... 7.2 Focal spot position... 7.3 Power plug specification... 7.3.1 Systems with a voltage rating of 100V and 120V... 7.3.2 Systems with a voltage rating of 200V, 220V, 230V and 240V ... 7.4 Connections for additional monitors and external radiation indication lamp... 7.5 Laser positioning device ... 7.6 Dose meter ... 7.7 Failure of the power supply ... 7.8 Air kerma ... 7.9 Dimensions...

7-1 7-1 7-3 7-6 7-9 7-10 7-10 7-11 7-12 7-13 7-14 7-15 7-15 7-20

8

Maintenance 8.1 General requirements... 8.2 Electrics ... 8.3 Mechanics ... 8.4 Seasoning the generator X-ray tube...

8-1 8-1 8-2 8-4 8-5

9

Data Security (HIPAA) 9.1 Overview... 9.2 Exporting and deleting log files... 9.3 Log file structure ...

9-1 9-1 9-2 9-3

6.3

6.4

6.5

6.6

6.7

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Contents

10

Replacing Components 10.1 Hand switch and foot switch... 10.2 Fuses... 10.2.1 Mains fuse on the C-arm stand ... 10.2.2 Fuses on the C-arm stand...

11

Troubleshooting 11-1 11.1 List of error and alert messages... 11-1 11.2 What to do if ... ... 11-9

12

Disassembling the System 12-1 12.1 Dismounting the monitor head ... 12-1 12.2 Dismounting the Solo Center ... 12-3

13

Mounting the System on a Pallet 13-1 13.1 Safety instructions and information ... 13-1 13.1.1 Safety instructions... 13-1 13.1.2 Information ... 13-1 13.1.3 Environmental conditions ... 13-2 13.2 Packing material and contents ... 13-3 13.2.1 Material ... 13-3 13.2.2 Parts to be packed ... 13-5 13.3 Packing the C-arm stand... 13-6 13.4 Packing the monitor head... 13-12 13.5 Packing the Solo Center... 13-14 13.6 How to pack the accessories... 13-16 13.7 Packing the ramp ... 13-17 13.8 Packing the full pallet ... 13-19 Appendix A.1 Manufacturer’s Declaration concerning Electromagnetic Compatibility according to IEC 60601-1-2 (Class A)... Index

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10-1 10-1 10-3 10-3 10-4

A-1 A-1 i

III

Contents

IV

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Ziehm Solo Technical Manual

Ziehm Solo P_28484_CD_28485 - EN-28/05/2010

Copyright Copyright © 2010 Ziehm Imaging GmbH All rights reserved. Transmission or reproduction of this document, exploitation and disclosure of its contents to third persons is not permitted without express written consent of the manufacturer. Infringements shall entitle to damage claims.

Quality Standards This document was produced in accordance with a certified QM system as per DIN EN ISO 13485. They conform to the requirements of Council Directive 93/42 EEC, Annex I, and other applicable norms. The information provided in this document may be updated at regular intervals. Subject to change without prior notice.

Registered Trademarks This document may contain the names of registered trademarks or brands, the use of which by third persons for their purposes may infringe the rights of their respective owners.

Manufactured by: Ziehm Imaging GmbH Donaustr. 31 90451 Nuremberg (Germany) e-mail: [email protected] http://www.ziehm.com Rev. 052010

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With the Ziehm Solo, Ziehm Imaging GmbH provides an active medical device connected to the mains power supply. The above listed medical device is a non-contact device. It does not require any contact with the patient to perform its intended use. It provides contactless energy in the form of X-rays.

Preface

Ziehm Imaging GmbH authorizes only trained and skilled personnel to operate this medical device. The system is intended for use by health care professionals such as physicians, orthopedic surgeons, vascular surgeons, neurovascular surgeons, cardiologists, radiologists and technologists in hospitals, outpatient clinics and other clinical environments. Ziehm Imaging GmbH anticipates the system will be used on a nearly daily basis. Ziehm Imaging GmbH applications specialists and/or qualified site personnel provide on-site operator training in the proper use of the system. The Ziehm Solo is a mobile C-arm. Using a non-invasive X-ray method during surgical intervention, it provides image information and stores this temporarily.

Intended use

The Ziehm Solo can be used for all medical indications where fluoroscopy is required. The system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The system can be used for the whole human body without restriction (e.g. organs, tissue, bones, implants) depending on the medical indication. This device is not intended for use in performing mammographic exposures. The Ziehm Solo is intended to provide contactless fluoroscopy imaging, capturing, temporarily storing and display of non-invasive X-ray imaging of the patient using pulsed and continuous fluoroscopy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the image intensifier. This device does not support and is not intended for use in performing mammographic imaging.

Indications for use

The system provides contactless fluoroscopy and according to this does not have applied parts.

Normal use

The system may only be used in heights up to 6561.7 ft (2000 m) above sea level and must be used within the limits defined by the technical specification. The use of the system is only allowed in rooms used for medical purposes in accordance with EMC class A as well as with protective earth conductor. The system may only be used in an environment with an oxygen saturation of < 25%. The system must be maintained regularly according to the maintenance procedures by qualified personnel authorized by Ziehm Imaging GmbH. The system may only be used in faultless condition and in accordance with the terms set forth by the operating instructions. The system is not suitable for interventional procedures acc. to IEC 60601-2-43.

Exclusions

The monitors are not suitable for diagnostic purposes. The system may only be operated by personnel who has undergone radiological training.

Operation

In the USA, Federal law restricts use of this device to trained personnel on the order of a physician.

Operation (USA)

Only authorized personnel are allowed to assemble and/or repair the medical equipment described in this document. Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer.

Authorized personnel

The exposure of humans to ionizing radiation must always be medically justified. Especially when used on pregnant women, adolescents, children, and pediatric patients, all procedures using ionizing radiation should be used with caution or be avoided altogether. However, the final decision lies with the attending physician or attending surgeon.

Contraindications to the use of X-rays

The monitors are not suitable for diagnostic purposes. The manufacturer accepts responsibility for the safety, reliability and performance of the system only if −

any installation, modification or repair work is carried out exclusively by persons authorized by the manufacturer;

−

the electrical installation of the site where the system is operated complies with the requirements of VDE 0107 or the corresponding national regulations of the country of installation;

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Exclusion of liability

3

−

only original spare parts or components that comply with Ziehm Imaging’s specifications are used;

−

the system is used in accordance with the Operating Instructions.

The warranty becomes invalid in case that any repair, modification or installation work is carried out by unauthorized personnel, or any seals on components are broken. No consequential damages will be accepted either. The equipment conforms to Class IIb according to Council Directive 93/42/EEC. This document has been written and reviewed originally in German and translated.

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General Information

This manual is designed to enable owners and operators of the system to operate the systems described herein safely and efficiently. Ziehm Solo, software version 5.28.2 or higher. All illustrations in these Operating Instructions are exemplary only, and may differ from the actual situation.

Scope of validity of this manual

This manual describes a system with maximum configuration. The system configuration chosen by you may not contain all options and functions described here. For several system options, separate operating instructions may be available. They are supplied with the system, provided that the system configuration includes the respective option. You will find a corresponding reference to those operating instructions in the relevant sections of this manual.

Separate operating instructions

The system does not produce any waste during operation.

Environmental compatibility

When the system has reached the end of its useful service life, the relevant waste disposal regulations of the country of installation must be observed. Ziehm Imaging GmbH takes back your devices and undertakes to dispose of them appropriately in accordance with national regulations. If you want to return a device, please contact the Ziehm Imaging Service department. The useful service life defined for this medical device is seven years. For this period Ziehm Imaging GmbH warrants that spare parts can be supplied. After this period, Ziehm Imaging GmbH must check whether the technology used is appropriate.

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1 General Information

1.1

Typographical conventions In this document, the following notations and formats are used to highlight certain elements of the control panel Solo Center or the documentation itself: Element

Format

Example

Solo Centerelements (buttons and boxes), operating modes, functions, modes

Bold

Fluoro

Cross-references

Italic, preceded by an arrow

→ Ch. 5, p. 5-1

Procedure steps

Preceded by a •

• Press the OK button.

Text input

Courier, bold

Administrator

Table 1-1

1-2

Notations and formats used in this document

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1 General Information

1.2

Conventions for safety instructions

The present document does not constitute a complete catalog of all safety measures necessary for the operation of the respective medical equipment, since special operating conditions may require further measures. However, it does contain instructions which must be observed in order to ensure the personal safety of operating staff and patients as well as to avoid damage to property. These instructions are highlighted as follows: DANGER DANGER indicates a hazardous situation which, if not avoided, will result in death or serious injury.

WARNING WARNING indicates a hazardous situation which, if not avoided, may result in death or serious injury.

CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE NOTICE indicates a property damage message. NOTE Notes are merely informative. Additional useful information and hints are provided for the operator here.

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1 General Information

1.3

Accessories

All systems

The accessories are in a separate cardboard box on the pallet. Depending on the system configuration (options), the cardboard box contains the following accessory items: Accessories

Qty.

Operating Instructions

1

DVD (Operating Instructions)

1

DVD (Technical Manual)

1

DVD (Service Manual: Sweden, Iceland and Ukraine)

1

Specifications and Certificates

1

Quick Guide

3

Equipotential grounding cable (6 m) (Art. No. 24054)

1

Touch-up paint RAL 9001 (Art. No. 89655)

1

Touch-up paint RAL 6027 (Art. No. 89615)

1

USB stick

1

Mounting material (for systems on pallet: Art. No. 88711)

1

Cassette holder Cassette holder for a 23 cm image intensifier, format 18 × 24 (Art. No. 88113)

1

Options

Video printer Operating instructions for video printer

1

Printer paper

1 roll

DVD writer DVD (4.7 GB)

1

DICOM RJ45 interface with Cat.5 patch cable (10 m) (Art. No. 24452)

1

Wireless LAN: Transceiver

1

Table 1-2

1-4

Accessories

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All systems

1 General Information

Accessories USA:

Qty.

Operating Instructions

1

DVD (Operating Instructions)

1

Technical Manual

1

DVD (Technical Manual)

1

DVD (Service Manual)

1

CDRH Maintenance Report

1

Specifications and Certificates

1

Quick Guide

3

Equipotential grounding cable (6 m) (Art. No. 24054)

1

Mounting material (Art. No. 88711)

1 set

Skin cone with safety label (Art. No. 89694)

1

Touch-up paint RAL 9001 (Art. No. 89655)

1

Touch-up paint RAL 6027 (Art. No. 89615)

1

Cassette holder Cassette holder for a 23 cm image intensifier, format 18 × 24 (Art. No. 88113)

1

Options

Video printer Operating instructions for video printer

1

Printer paper

1 roll

DVD writer DVD (4.7 GB)

1

DICOM RJ45 interface with Cat.5 patch cable (10 m) (Art. No. 24452) Table 1-3

1

Accessories USA

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1 General Information

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Safety Instructions

2.1

General safety instructions WARNING You must be familiar with the contents of the present Operating Instructions in order to be able to operate the system as intended. Study the Operating Instructions thoroughly before operating the system. It is important to observe all directions, safety instructions and warnings! The responsibility for any C-arm-assisted intervention lies with the physician in charge. NOTICE Supplementary equipment used in combination with the Ziehm Solo must comply with the safety requirements according to IEC 60601-1 and/or IEC 60601-1-1 or furnish proof of an equivalent degree of safety. To ensure CE conformity, these components must have a CE approval in accordance with Council Directive 93/42/ EEC. In addition, a declaration in compliance with Article 12 of the said directive must be provided. For components without CE approval, a conformity assessment procedure is obligatory. If you combine the Ziehm Solo with equipment which does not comply with these requirements, the safety of the entire system is no longer given and the warranty will become invalid. Please note that a combination with third-party devices must be approved by Ziehm Imaging. A combination must be possible in particular by the intended use of the two devices.

Only trained and instructed personnel are allowed to operate the system.

Operation

The system may only be operated by properly trained personnel under the direction of a physician.

Operation (USA)

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2 Safety Instructions

Assembly and service

Only authorized personnel are allowed to assemble the system and to provide technical service. The necessary qualifications can only be obtained by attending a training course provided by the manufacturer. CAUTION Always observe the relevant regulations of the country of installation for putting the system into service, training of personnel and maintenance.

WARNING Never use the system if you suspect any electrical or radiation-generating components to be defective or if the system exhibits unexpected malfunctions!

2.2 General

X-rays The system produces X-rays. If you do not observe the safety measures and precautions required by your local radiation protection regulatory body or other national radiation protection measures and precautions, these X-rays can be hazardous both to operating staff and other persons within the radiation zone of occupancy. WARNING The system is intended for procedures where the skin dose may be so high that there is a risk of deterministic effects, even if the system is used as intended.

WARNING The system may only be operated by personnel who has undergone radiological training.

WARNING (USA) The system may only be operated by properly trained personnel under the direction of a physician.

2-2

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2 Safety Instructions

WARNING The relevant radiation protection regulations of the country of installation must be observed.

WARNING In order to avoid unintentional radiation, the foot switch must be hung up on the foot switch support when the system is switched on, but not in use.

Staff members who stay within the radiation controlled area must wear Xray protective clothing.

Protection of staff

The radiation controlled area has a radius of 4 m. To minimize the radiation burden of the patient, you must keep the source/skin distance as large as possible. The generator design guarantees a minimum source/skin distance of 20 cm (USA: 30 cm).

Protection of the patient

WARNING Additional material located in the beam path (e.g. an operating table not suitable for X-raying) may result in a dose increase when using a fluoroscopy mode with automatic exposure rate control. WARNING When you initiate radiation and no live image is displayed although all necessary settings have definitely been made, please contact your after-sales service center!

2.3

Electromagnetic compatibility

Medical electrical equipment requires special precautionary measures with respect to EMC and must be installed and put into service in accordance with the EMC guidelines contained in the accompanying documents. Portable and mobile RF communications equipment may interfere with medical electrical equipment. All operating modes of the system have been considered in the EMC tests. There are no exceptions to the rules.

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2 Safety Instructions

Only conductors, connecting cables and accessories that are specified by the manufacturer may be used. WARNING Using components other than those specified may result in increased electromagnetic emissions or reduced electromagnetic immunity.

Please observe also Ch. A.1, Manufacturer’s Declaration concerning Electromagnetic Compatibility according to IEC 60601-1-2 (Class A)!

2.4

Protective grounding The system must be connected only to power systems having a separate ground connection.

2.5

Equipotential grounding

Heart and brain examinations

2-4

If you use the system in combination with other equipment for examinations of the heart or brain or the surrounding anatomical regions, equipotential grounding is required for patient and operating staff safety (IEC 60601-1-1).

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2.6

Laser radiation

As an option, the system may be equipped with a laser positioning device at the image receptor and/or generator.

Laser positioning device

The laser positioning device uses diode laser modules which emit laser radiation. Do not under any circumstances look directly at the laser beam or any scattered laser radiation – either with the naked eye or with optical instruments. The laser positioning device is a Class 2M laser product according to IEC 60825-1. Make sure to comply with all operating safety precautions when using the laser positioning device. The maximum power output of continuous laser radiation, measured at the laser beam apertures, is <1 mW. The wavelength of the emitted radiation is 635 nm. WARNING Laser radiation – Do not stare into beam or view directly with optical instruments (Laser Class 2M according to IEC 60825-1). Please observe the provisions of IEC 60825-1, Section 3, “User’s Guide” for operation of the laser positioning device. Viewing the laser output with certain optical instruments (e.g. eye loupes, magnifiers and microscopes) within a distance of 100 mm may pose an eye hazard. CAUTION (USA) LASER RADIATION – DO NOT STARE INTO BEAM CLASS II LASER PRODUCT (in accordance with FDA 21 CFR, Subchapter J, Section 1040.10-11)

The laser positioning device is maintenance-free. Any adjustment or repair work which might become necessary must be carried out by the manufacturer or a person who has been authorized to do so by the manufacturer.

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Maintenance

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2 Safety Instructions

Laser beam apertures

Laser beam apertures

Fig. 2-1

2.7

Laser beam apertures on the image intensifier (left) and on the generator (right)

Temperature

Generator housing

CAUTION The generator housing can reach a temperature of 48°C. Prolonged contact with the generator housing (longer than 1 minute) may result in burns. Make sure that the patient does not get in contact with the generator housing.

2-6

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