PHILIPS Zenition 30 Mobile C Arms Instruction Manual
- June 13, 2024
- Philips
Table of Contents
Zenition 30 Mobile C Arms
Product Information
The Philips Zenition 30 is a medical imaging system designed for
diagnostic and interventional procedures. It consists of a C-arm
stand and a mobile view station, offering flexibility and ease of
use in various medical settings.
The system is equipped with various safety features to ensure
patient and operator safety, including emergency procedures,
electrical safety measures, transportation safety guidelines, and
radiation safety management.
Additionally, the Zenition 30 system offers customizable options
such as wired foot switch, paper printer, position tracking,
encrypted PC, spring bow, touch screen module, laser aiming
devices, remote control, surgeon arm, warning light connection,
video converter, DICOM/IHE interface, vascular extension, pain
extension, cardiac extension, multi-modality viewer, external video
outline tool, pediatric utilization information, and digital
navigation link.
Product Usage Instructions
Installation
To install the Zenition 30 system:
-
Set up the user interface, including the mobile view station
and C-arm stand. -
Configure the system settings, such as modifying the physician
list, date and time, user interface language, and instructions for
use language. -
Customize the system according to your specific
requirements.
System Overview
The Zenition 30 system consists of the following components:
- C-arm stand
- Mobile view station
- Mobile view station connector panel
- Spacers
- Wireless LAN
The system also offers various optional accessories such as a
wired foot switch, paper printer, position tracking, encrypted PC,
spring bow, touch screen module, laser aiming devices, remote
control, surgeon arm, warning light connection, video converter,
DICOM/IHE interface, vascular extension, pain extension, and
cardiac extension.
Operation
Ensure safety during operation by following these
guidelines:
-
Take necessary precautions during transportation, including
putting the C-arm in the transport position and moving the system
safely. -
Properly position the C-arm for accurate imaging.
-
Familiarize yourself with the C-arm brakes and movements,
including electronic brake switches, rotation, angulation,
longitudinal movement, swivel movement, height movement, and the
electronic brake switches status indicator. -
Connect and switch on the system following the provided
instructions. Switch users and change passwords if necessary.
Follow the appropriate procedures for switching off the system and
emergency power off. -
Utilize the monitors for viewing information and images.
-
Access information and help on the C-arm stand when
needed.
For detailed instructions on using specific features or
functionalities of the Zenition 30 system, refer to the
corresponding sections in the user manual.
Instructions for Use English
3000 095 56112
Philips Zenition 30
Release 1.0
Contents
1 Introduction
1.1
About the Zenition 30 System
1.2
About Instructions for Use
1.3
Intended Use
1.4
Contraindications
1.5
Compatibility
1.6
Compliance
1.7
Training
1.8
Other Manuals
1.9
Contacting the Manufacturer
2 Safety
2.1
Important Safety Directions
2.2
Emergency Procedures
2.2.1
Emergency Power Off
2.2.2
Recovery Procedure
2.3
Reporting a Serious Incident
2.4
Electrical Safety
2.4.1
Equipotential Ground Connection
2.5
Transportation Safety
2.6
Mechanical Safety
2.7
Explosion Safety
2.8
Fire Safety
2.9
Mobile Telephones and Similar Products
2.10
Electromagnetic Compatibility
2.11
Radiation Safety
2.11.1
Skin Dose Management
2.11.2 Radiation Guidelines
2.11.3 Pediatric Radiation Guidelines
2.12
Laser Light Radiation Safety
2.13
Labels and Symbols
2.13.1
Labels
2.13.2 Symbols
2.14
Information Regarding Substances in the System
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3 Installation
3.1
User Interface
3.1.1
Mobile View Station
3.1.2
C-arm Stand
3.2
System Setup
3.2.1
Modifying the Physician List
3.2.2
Modifying the Date and Time
3.2.3
Displaying the IQ Test Image
3.2.4
Changing the User Interface Language
3.2.5
Changing the Instructions for Use Language
3.2.6
Changing the Default Examination Type
3.3
Customizing
4 System Overview
4.1
About the Zenition 30 System
4.2
Composition
4.2.1
The C-arm Stand
4.2.2
The Mobile View Station
4.2.3
Mobile View Station Connector Panel
4.2.4
Spacers
4.2.5
Wireless LAN
4.3
Options
4.3.1
Wired Foot Switch
4.3.2
Paper Printer
4.3.3
Position tracking
4.3.4
Encrypted PC
4.3.5
Spring Bow
4.3.6 Touch Screen Module (TSM)
4.3.7
Laser Aiming Devices
4.3.8
Remote Control
4.3.9 Surgeon Arm
4.3.10 Warning light connection
4.3.11 Video converter
4.3.12 DICOM/IHE Interface
4.3.13 Vascular Extension
4.3.14 Pain Extension
4.3.15 Cardiac Extension
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4.3.16 4.3.17 4.3.18 4.3.19 4.3.20 4.3.21 4.3.22
Multi-Modality Viewer External Video Outline Tool Pediatric Utilization Information Digital Navigation Link 4kW
5 Operation
5.1
Safety
5.2
Transportation
5.2.1
Putting the C-arm in the Transport Position
5.2.2
Moving the C-arm Stand
5.2.3
Moving the Mobile View Station
5.2.4
Putting the Monitors in the Transport Position
5.3
Positioning
5.3.1
C-arm Repositioning
5.4
C-arm Brakes and Movements
5.4.1
Electronic Brake Switches
5.4.2
Rotation
5.4.3
Angulation
5.4.4
Longitudinal Movement
5.4.5
Swivel (Wig-Wag) Movement
5.4.6 Height Movement
5.4.7
Electronic Brake Switches Status indicator
5.5
System On/Off
5.5.1
Connecting the System
5.5.2
Switching the System On
5.5.3
Switching Users
5.5.4
Changing Your Password
5.5.5
Switching the System Off
5.5.6 Emergency Power Off
5.5.7
Mains Failure
5.6
Monitors
5.7
Information and Help
5.7.1
Information and Help on the C-arm Stand
5.7.2
Information and Help on the Mobile View Station
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5.8
Managing Patients and Examinations
91
5.8.1
The Schedule List
93
5.8.2
The Review List
94
5.8.3
Querying the Worklist Management Server (Option)
94
5.8.4 Importing External Data
96
5.8.5
Adding a New Examination
97
5.8.6 Modifying an Examination
99
5.8.7
Deleting an Examination
99
5.8.8 Selecting a Patient for Acquisition
100
5.8.9 Closing the Current Acquisition Examination
100
5.8.10 DICOM Radiation Dose Structured Report
101
5.9
Configuring a User Profile
101
5.9.1
Add Profile
102
5.9.2 Modifying a User Profile
104
5.9.3 Deleting a User Profile
105
5.10
System Readiness
105
5.11
Acquiring Images
105
5.12
Heat Indications
107
5.13
Acquisition Modes
109
5.14
Making Fluoroscopy Images
111
5.14.1 Fluoroscopy Grab of a Live Image
112
5.15
Making Exposure Images
113
5.16
Making Single Shot Images
114
5.17
Making Vascular Images
114
5.17.1
Performing Subtraction
114
5.17.2 Performing Roadmap after Subtraction
116
5.17.3 Performing Roadmap with Trace (Peak Opacification)
116
5.17.4 CO2 Acquisition Modes
117
5.17.5 Remasking
118
5.17.6 Bolus Chase
118
5.18
Imaging Essentials
119
5.18.1 Detector Zoom
119
5.18.2 Contrast and Brightness
120
5.18.3 Rotating Images
121
5.18.4 Mirroring and Flipping Images
122
5.18.5 Automatic Shutter Positioning
122
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5.18.6 Collimator and Shutter Adjustments in Last Image Hold
123
5.18.7 Automatic kV/mA control
124
5.18.8 Manual kV/mA Control
125
5.18.9 Pulse Rate
125
5.18.10 Dose Level
126
5.18.11 Storage Rate
128
5.19
ClearGuide
128
5.19.1 Using ClearGuide
130
5.20
Image Review
131
5.20.1 Selecting an Examination for Review
131
5.20.2 Image Navigation panel
131
5.20.3 Single Image Screen
132
5.20.4 Overview Screen
137
5.20.5 Run Cycle Review
140
5.20.6 Dose Report
142
5.20.7 Reviewing Other Examinations During Acquisition
143
5.21
Protection and Image Storage Management
143
5.21.1 Protecting Images
144
5.21.2 Parking an Image to the Reference Monitor
145
5.21.3 Auto park
146
5.22
Image Processing
148
5.22.1 Adjusting Contrast and Brightness
148
5.22.2 Enhancing Edges
149
5.22.3 Video Invert
149
5.22.4 Adding Annotations and Remarks
150
5.22.5 Zooming
151
5.22.6 Measure
152
5.22.7 Pixelshift
157
5.22.8 Landmarking
158
5.22.9 View Trace Using the MVS
158
5.22.10 View Trace Using the C-arm Stand
159
5.22.11 Manual Electronic Blanking
159
5.22.12 Automatic Electronic Blanking (AEB)
160
5.23
Exporting, Saving, and Printing
161
5.23.1 Selecting Images to Export, Save, or Print
161
5.23.2 Exporting Images to a Network Location
163
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5.24 5.25
5.26
5.23.3 Saving Images to Local Media 5.23.4 Printing Images (Option) 5.23.5 Viewing Transfer Jobs in the Job Viewer 5.23.6 Printing the Examination Monitor Screen (Option) 5.23.7 Saving a Snapshot of the Examination Monitor Screen to USB 5.23.8 Saving Images for Service 5.23.9 Save Log File for Service Wireless Network Option 5.24.1 Switching the Wireless Network Connection On and Off Options 5.25.1 Laser Aiming Devices 5.25.2 Position Tracking 5.25.3 Outline Tool 5.25.4 Viewing External Video 5.25.5 Spring Bow 5.25.6 Touch Screen Module (TSM) 5.25.7 Connecting the Wired Foot Switch External Connected Equipment
6 System and Error Messages
6.1
C-arm Stand
6.1.1
Viewing Messages on the C-arm Stand
6.2
Mobile View Station
6.3
Printer (Option)
6.4
Image Viewer (Option)
7 Maintenance
7.1
Planned Maintenance Program
7.1.1
General Checks
7.1.2
Mechanical Checks
7.1.3
Functional Checks
7.1.4
Radiation Safety Checks
7.1.5
Image Quality Checks
7.1.6
Electrical Safety Checks
7.2
Remote Assistance
7.2.1
Enabling and Disabling Remote Assistance
7.3
Field Service
7.3.1
Starting Field Service
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7.4
User Routine Checks Program
7.4.1
Buzzer Test C-arm Stand
7.4.2
Light Test on the Mobile View Station
7.4.3
X-ray Control Function Check
7.4.4
Collimator Check
7.4.5
Tube Laser Alignment Device Check
7.4.6
X-ray Detector Laser Alignment Device Check
7.5
Cleaning and Disinfecting
7.5.1
Cleaning
7.5.2
Disinfecting
7.6
Replacing and Charging Batteries
7.7
Environmental Impact of the System
8 Product Disposal
8.1
Passing the System on to Another Responsible Organization
8.2
Final Disposal of the System
8.3
Disposing of Batteries
8.3.1
Remote Control Batteries
8.3.2
Mobile View Station PC Battery
9 Technical Data
9.1
Standards and Regulations
9.1.1
Electromagnetic Compatibility
9.2
Main Components
9.2.1
X-ray Inverter / Control Unit
9.2.2
X-ray Tube
9.2.3
X-ray Tube Assembly
9.2.4 X-ray Source Assembly
9.2.5 Beam Limiting Device (BLD)
9.2.6 Image Detection Subsystem
9.2.7
Digital Image Processor
9.2.8 Monitors
9.2.9 Detector Laser Aiming Device
9.2.10 Wireless LAN
9.3
System Data
9.3.1
Environmental Conditions
9.3.2
System Loading Data
9.3.3 Maximum Loading Factors
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9.3.4 9.3.5 9.3.6 9.3.7 9.3.8 9.3.9 9.3.10 9.3.11 9.3.12 9.3.13 9.3.14 9.3.15 9.3.16 9.3.17
Display Accuracy Measurement Basis for Approval Tests Acquisition Parameter Settings Patient Dose Information – Dose Rate With Grid Patient Dose Information – Dose Rate Without Grid Designated Significant Zone of Occupancy Scattered Radiation (Isokerma Data) C-arm Stand Dimensions Mobile View Station Dimensions Certifiable Items Open Source Software Options Connectivity Power Supply
10 Glossary
10.1
Abbreviations
10.2
Definitions and Terms
11 Appendix
11.1
Special Characters
11.2
Menu and Function Selection Tree
11.3
Quantitative Data
11.4
Security and Privacy Provisions
11.4.1
Risks Related to Hospital Network Connectivity
11.4.2 Access Control
11.4.3 Screen Blanking and Automatic Log-Off
11.4.4 De-identification of Patient Data
11.4.5 Backing Up Patient Data
11.4.6 Archiving Patient Data
11.4.7 Disaster Recovery
11.4.8 Network Security
11.4.9 Patient Data Storage
11.4.10 Patient Data Transmission
11.4.11 Service Data Transmission
11.4.12 Malware Protection
11.4.13 Audit Trail
11.5
Device Identifier
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11.6
Council Directive 2013/59 EURATOM
11.7
DIN6868-157 Compliance Testing
11.7.1
Introduction
11.7.2
IQ Test Image Types
11.7.3
Navigate through Test Images
11.7.4 Preparation for Test
12 Legends
12.1
Mobile View Station Console
12.2
C-arm Stand Console
12.3
C-arm Stand Touch Screen
12.4
C-arm Stand Height Movement
12.5
Hand Switch
12.6
Foot Switch
12.7
Remote Control
12.8
Touch Screen Gestures
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Introduction
About the Zenition 30 System
1 Introduction
This section introduces the equipment and the manual, plus related topics such
as intended use, contraindications, compatibility, compliance, training and
other manuals.
1.1 About the Zenition 30 System
Zenition 30 is a mobile, diagnostic X-ray imaging and viewing system. It is
designed for medical use in healthcare facilities where X-ray imaging is
needed.
Figure 1 System overview: C-arm stand (left) and mobile view station (right)
The system is intended for multiple patients for multiple use.
1.2 About Instructions for Use
This manual is intended to assist responsible users, operators, and
organizations in the safe and effective operation of the equipment described.
These Instructions for Use may describe some features or configurations that
are not available in all countries. Please contact your local sales
representative for the availability of products and features in your region.
The “users” and “operators” are those persons who actually handle the
equipment, and the “responsible organization” is considered to be the entity
accountable for the use and maintenance of the equipment. Before attempting to
operate the equipment, you must read, note, and strictly observe all DANGER
notices and SAFETY markings on the system.
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Introduction
Intended Use
Before attempting to operate the equipment, you must read this manual
thoroughly, paying particular attention to all WARNINGS, CAUTIONS, and NOTES
incorporated in it. You must pay special attention to all the information
given and procedures described in Safety (page 16). WARNING A warning alerts
you to a potential serious outcome, adverse event or safety hazard. Failure to
observe a warning may result in death or serious injury to the user or
patient. CAUTION A caution alerts you to where special care is necessary for
the safe and effective use of the product. Failure to observe a caution may
result in minor or moderate personal injury or damage to the product or other
property, and possibly in a remote risk of more serious injury, and/or cause
environmental pollution. NOTE A note highlights unusual points as an aid to a
user.
These Instructions for Use describe the most extensive configuration of the
system, with the maximum number of options. Not every function described may
be available on your system. NOTE The images present in “Instructions for Use”
are only for indicative purposes.
The English language version of the Instructions for Use was originally
drafted, approved and supplied by Philips Medical Systems under the product
part code (document number) 3000 095 5611X, which is indicated on the rear of
the title page of the English language version. NOTE Last digit of part code
(12NC) mentioned as “X” in document can have values between 1 to 9. NOTE Not
all configuration are available in all geographies. Please reach out to your
Philips
representative for configuration and services in your area.
1.3 Intended Use
The Zenition 30 with flat detector is a mobile X-ray imaging and viewing
system. It is designed for medical use in healthcare facilities where X-ray
imaging is needed.
The system comprises of two main components: the C-arm stand and a mobile view
station.
Indications for Use / Medical Purpose The device is used for radiological
guidance and visualization during diagnostic, interventional and surgical
procedures on all patients. The device is to be used in health care facilities
both inside and outside the operating room, sterile as well as non-sterile
environment in a variety of procedures.
Applications: · Orthopedic · Neuro · Abdominal · Vascular · Thoracic · Cardiac
Intended Operator Profile The Zenition 30 device is intended to be used and
operated by: adequately trained, qualified and authorized health care
professionals who have full understanding of the safety information and
emergency procedures as well as the capabilities and functions of the device.
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Introduction
Contraindications
Patient Population Patients can be any human of whom any part of the body
(from head to toe) can be subject of examination.
Clinical Environment The device is to be used in health care facilities both
inside and outside the operating room, sterile as well as non-sterile
environment.
This system is intended to use with multiple patients and multiple uses. For
more information see Maintenance (page 190)
General Safety and Effectiveness To facilitate safe and efficacious operation
of the system by a trained healthcare professional, instructions for use are
provided as part of the device labeling, as well as training at system
handover.
Operating Principle The system uses X-ray generation, detection and image
processing for medical imaging; and in addition displays images from other
sources (e.g. ultrasound). The control mechanisms are input devices (touch
panels) and controls for e.g. geometry and table movements. The systems
provides feedback by audible and visual means. CAUTION In the United States,
Federal law restricts this device to sale, distribution, and use by, or on the
order of, a physician.
1.4 Contraindications
Avoid using the system with patients who are pregnant or who may possibly be
pregnant. However, the risk may be outweighed by the benefit of diagnosing or
treating a serious condition. It is the responsibility of the personnel
operating the system to make the decision. Avoid using the system in case of
existing radiation injury (operator or patient).
1.5 Compatibility
Equipment described in this manual should not be used in combination with
other equipment or components unless such other equipment or components are
expressly recognized as compatible by Philips Medical Systems.
A list of such equipment and components is available on request from the
contact address given under the following heading Compliance.
Changes and/or additions to the equipment should only be carried out by
Philips Medical Systems or by third parties expressly authorized by Philips
Medical Systems to do so. Such changes and/or additions must comply with all
applicable laws and regulations that have the force of law within the
jurisdiction(s) concerned, and with best engineering practice.
Changes and/or additions to the equipment that are carried out by persons
without the appropriate training and/or using unapproved spare parts may lead
to the Philips Medical Systems warranty being voided. As with all complex
technical equipment, maintenance by persons not appropriately qualified and/or
using unapproved spare parts carries serious risks of damage to the equipment
and of personal injury.
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Introduction
Compliance
1.6 Compliance
The system complies with relevant international and national standards and
laws. Information on compliance will be supplied on request by your local
Philips Medical Systems representative. Alternatively, contact the
manufacturer For more information, see Contacting the Manufacturer (page 15)
NOTE The system does not contain any patient applied parts.
1.7 Training
Users and operators of the system must have received adequate training on its
safe and effective use before attempting to operate the equipment described in
this manual.
Training requirements for this type of device will vary from country to
country. It is for responsible organizations to make sure that users and
operators receive adequate training in accordance with local laws or
regulations which have the force of law.
If you require further information about training in the use of this
equipment, please contact your local Philips Medical Systems representative.
Alternatively, contact the manufacturer. For more information, see Contacting
the Manufacturer (page 15)
1.8 Other Manuals
This manual describes the Zenition 30 system. Other pieces of equipment may be
used with the system. These units are supplied with their own manuals.
1.9 Contacting the Manufacturer
You can contact the manufacturer by post or by email.
Manufacturer’s Address Postal address
Philips Medical Systems Nederland B.V. Veenpluis 6, 5684 PC Best The Netherlands
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Safety
Important Safety Directions
2 Safety
This section provides important safety-related information about the system.
2.1 Important Safety Directions
Philips Medical Systems products are all designed to meet stringent safety
standards.
However, all medical electrical equipment requires proper operation and
maintenance, particularly with regard to human safety. It is vital that you
read, note, and where applicable strictly observe all DANGER notices and
safety markings on the system. It is vital that you strictly follow all safety
directions under the heading SAFETY and all WARNINGS and CAUTIONS throughout
this manual, to help ensure the safety of both patients and operators.
In particular, you must read, understand and know the Emergency procedures
described in this SAFETY section before attempting to use the equipment for
any patient examination.
You should also note the following information given in the Introduction
section of this manual: · Intended Use (page 13) · Contraindications (page 14)
· Compatibility (page 14) · Training (page 15)
NOTE In case of serious incident, please contact the manufacturer. For more
information, please refer to Contacting the Manufacturer (page 15)
Maintenance and Faults WARNING Do not use the system for any application until
you are sure that the user routine checks program has been satisfactorily
completed, and that the planned maintenance program is up-to-date. WARNING If
any part of the equipment or system is known (or suspected) to be defective or
wrongly-adjusted, do not use the system. Contact technical support to arrange
a repair. Operation of the equipment or system with defective or wrongly-
adjusted components could expose the operator or the patient to radiation or
other safety hazards. This could lead to fatal or other serious personal
injury, or to clinical misdiagnosis/mistreatment.
You can find information about the user routine checks program and the planned
maintenance program in Maintenance (page 190).
Safety Awareness WARNING Do not use the system for any application until you
have read and understood and know all the safety information, safety
procedures and emergency procedures contained in these Instructions for Use.
Operation of the system without proper awareness of how to use it safely could
lead to fatal or other serious personal injury. It could also lead to clinical
misdiagnosis/mistreatment.
CAUTION During a procedure, ensure that patient drapes do not get stuck inside
the C-arm.
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Safety
Emergency Procedures
WARNING Do not allow the sterile covers to touch the floor or non-sterile
part.
Adequate Training WARNING Do not use the system for any application until you
have received adequate and proper training in its safe and effective
operation. If you are unsure of your ability to operate this equipment safely
and effectively DO NOT USE IT. Operation of this equipment without proper and
adequate training could lead to fatal or other serious personal injury. It
could also lead to clinical misdiagnosis/ mistreatment. For information about
training, please refer to Training (page 15).
Intended Use and Compatibility NOTE Do not use the system for any purpose
other than those for which it is intended. See
Intended Use (page 13) WARNING Do not use the system with any products other
than those which Philips Medical Systems recognizes as compatible. For more
information, see Compatibility (page 14) WARNING Do not modify the equipment
without authorization of the manufacturer. Only authorized Philips
representative can modify the equipment if required by conducting appropriate
inspection and testing to ensure continued safe use of the equipment.
2.2 Emergency Procedures
This section provides important information about emergency procedures when
operating the system.
2.2.1 Emergency Power Off
In case of emergency, switch the system off. 1 To switch off only the C-arm
stand in an emergency, press the Emergency off button on the C-arm
stand console. X-ray generation and height movements are no longer available.
2 To switch off the system, press System off on the mobile view station.
3 Remove the mobile view station mains power plug from the socket outlet.
WARNING When the Emergency off button is pressed, mains power is still applied
to some circuits in the system until the mobile view station mains power plug
is removed from the socket outlet.
2.2.2 Recovery Procedure
Use this procedure if the system does not respond. 1 Press the System off
button on the mobile view station.
The system switches off (the shutdown time is less than 100 seconds).
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Safety
Reporting a Serious Incident
NOTE
For time critical situations, you can switch the system off faster by pressing the System off button for at least 3 seconds (shutdown time in this case is 3 seconds). This may cause data to be lost and may increase the system startup time (up to 5 minutes) for the next start.
2 Wait 5 seconds.
3 Press the System on button on the mobile view station.
The startup time for radioscopy imaging could be higher in case of abrupt shut down.
The system starts with default settings and a new patient. 4 Select the previously used examination type and acquisition mode.
When the procedure is finished, you can modify the patient name and other administration items for the current acquisition patient. You cannot continue the previous examination.
2.3 Reporting a Serious Incident
If a serious incident occurs in relation to the device, it should be reported
to the manufacturer and the competent authority of the country where you are
located. For contact details, see Contacting the Manufacturer (page 15) A
serious incident means any incident that directly or indirectly led to, might
have led to, or in case of recurrence, could lead to, any of the following: ·
The serious deterioration of the state of health (temporary or permanent) of a
patient, user or other
person. · A serious public health threat.
2.4 Electrical Safety
System covers or cables should only be removed by the qualified and authorized
service personnel.
In this context, qualified means those legally permitted to work on this type of medical electrical equipment in the jurisdiction(s) where the equipment is being used’, and authorized meansthose authorized by the responsible
organization’.
WARNING Do not remove system covers or cables from this equipment, unless
expressly instructed to do so in this manual. High electrical voltages are
present within this equipment. Removing system covers or cables could lead to
serious or fatal personal injury.
WARNING Do not touch the pins of the mobile view station C-arm cable or the
central pin of the video/USB connectors when touching the patient. Connector
contact pins may carry low voltages that are safe to touch, but that may be
harmful to the patient.
WARNING Do not touch the pins of the mobile view station C-arm cable plug
directly after the system is powered off, some residual voltage may remain.
WARNING In case of changing the X-ray on indicator light on the mobile view
station, do not touch the electrical contacts and the patient simultaneously.
Connector contact pins may carry low voltages that are safe to touch, but that
may be harmful to the patient.
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Transportation Safety
WARNING Only use this equipment in rooms or areas that comply with all
applicable laws (or regulations having the force of law) concerning electrical
safety for this type of equipment. WARNING Always electrically isolate this
equipment from the mains electrical supply before cleaning, disinfecting or
sterilizing it.
Cables Do not use multiple socket outlets or extension cables for installing
or connecting any part of the system. Such cables can compromise the
electrical safety of the system, especially for equipment in the examination
room near the patient.
2.4.1 Equipotential Ground Connection
An equipotential ground (earth) connection point and a connection cable are
provided for the safety of the patient. WARNING This equipment may only be
used in areas meeting local standards for electrical safety in rooms used for
medical purposes, for example the US National Electrical Code. IEC 60601 also
gives guidance about an equipotential ground (earth) connection point.
WARNING Use equipotential earthing lead between patient table and C-arm
system.
The system is provided with a yellow-green cable for equipotential earth
connection between the Carm stand and the patient support table. The
connection point is indicated by the equipotential earth symbol.
Alternatively, both the C-arm stand and the patient support table may be
connected to an earth (ground) bus bar provided for this purpose by the
hospital.
2.5 Transportation Safety
When moving mobile or transportable devices, make sure you do not collide
with/or run over objects and/or persons. The user must be familiar with the
brake system and all controls for steering before moving the equipment. Before
moving the system, ensure that the system is in the transport position. For
more information, see Putting the C-arm in the Transport Position (page 68).
Cross ramps, thresholds and obstacles as slowly as possible. Take extra care
on steep slopes. Wheel brakes must always be applied when the device is
stationary.
2.6 Mechanical Safety
System covers should only be removed by qualified and authorized service
personnel. In this context, qualified means those legally permitted to work on this type of medical electrical equipment in the jurisdiction(s) in which the equipment is being used’, and authorized meansthose authorized by the
organization responsible for the equipment’. Ordinary users and operators
should NEVER remove the system covers themselves.
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Explosion Safety
2.7 Explosion Safety
This equipment must not be used in the presence of explosive gases or vapors,
such as certain anaesthetic gases.
Use of electrical equipment in an environment for which it was not designed
can lead to fire or explosion. WARNING Do not use flammable or potentially
explosive disinfecting sprays. Such sprays create vapors which can ignite,
causing fatal or other serious personal injury, and/or damage to the
equipment.
2.8 Fire Safety
Use of electrical equipment in an environment for which it was not designed
can lead to fire or explosion.
Fire regulations for the type of medical area being used should be fully
applied, observed and enforced. Fire extinguishers should be provided for both
electrical and non-electrical fires. All operators of this medical electrical
equipment should be fully aware of, and trained in, the use of fire
extinguishers and other fire-fighting equipment, and in local fire procedures.
WARNING Only use extinguishers on electrical or chemical fires which are
specifically labeled for those purposes. Using water or other liquids on an
electrical fire can lead to fatal or other serious personal injury.
If it is safe to do so, attempt to isolate the equipment from electrical and
other supplies before attempting to fight a fire. This will reduce the risk of
electric shocks.
2.9 Mobile Telephones and Similar Products
The system complies with the requirements of applicable electromagnetic
compatibility (EMC) standards.
Other electronic equipment exceeding the limits defined in such EMC standards,
such as certain mobile telephones, could, under unusual circumstances, affect
the operation of the system. WARNING You should not allow any portable radio
transmitting devices (such as mobile telephones) into the examination room –
whether the device is switched on or off. Such devices could exceed EMC
radiation standards and, under unusual conditions, interfere with the proper
functioning of the system. This could, in extreme cases, lead to fatal or
other serious personal injury or to clinical mistreatment.
2.10 Electromagnetic Compatibility
The system is classified as Class A equipment, suitable for use in all
establishments other than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic
purposes.
The system complies with relevant international and national laws and
standards on EMC for this type of product when used as intended. Such laws and
standards define both the permissible
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Radiation Safety
electromagnetic emission levels from the product and its required immunity to
electromagnetic interference from external sources.
The system needs special precautions regarding EMC, and needs to be installed
and put into service according to EMC information provided in Electromagnetic
Compatibility (page 204).
All staff that could touch connectors identified with the ESD warning symbol
should receive training in ESD precautionary procedures. This training should
at least include an introduction to ESD physics, the voltage levels that can
occur in normal practice and the damage that can be done to electronic
components. Further methods of preventing the build-up of electrostatic charge
and methods for safe discharge, should be included.
WARNING Medical electrical products require special precautions regarding
electromagnetic compatibility, and should be installed and put into service
according to information provided in the accompanying documents.
WARNING The equipment should not be used adjacent to, or stacked with, other
equipment. If adjacent or stacked use is necessary, the responsible
organization must verify that the all equipment operates normally in the
configuration in which it will be used.
WARNING Use of accessories and cables other than those specified or provided
by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation. See also the tables of
electromagnetic emissions and immunity in Electromagnetic Compatibility (page
204)
WARNING The emissions characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required),
this equipment might not offer adequate protection to radiofrequency
communication services. The user might need to take mitigation measures, such
as relocating or reorienting the equipment.
WARNING Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the Zenition 30 system, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
WARNING This equipment is intended for use in a hospital environment.
Operation in other than hospital environments may compromise electromagnetic
compatibility.
NOTE In the event of systems essential performance is lost, please perform
steps as listed in section Recovery Procedure (page 17)
2.11 Radiation Safety
Only qualified and authorized personnel may operate this equipment.
In this context, qualified means those legally permitted to operate this type of medical electrical equipment in the jurisdiction(s) in which the equipment is being used’, and authorized meansthose authorized by the organization
responsible for the equipment’.
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Radiation Safety
Personnel operating the equipment and personnel within the examination room
must observe all laws and regulations which have the force of law within the
jurisdiction(s) concerned. If there is any doubt about these laws and
regulations, do not use it.
In addition, the responsible organization is strongly urged to become
acquainted with the current recommendations of the International Commission on
Radiological Protection, and in the United States, with those of the US
National Council for Radiological Protection. · ICRP, Pergamon Press, Oxford,
New York, Beijing, Frankfurt, São Paulo, Sydney, Tokyo, Toronto · NCRP, Suite
800, 7910 Woodmont Avenue, Bethesda, Maryland 20814, USA.
Full use must be made of all radiation protection features on the equipment,
and of all radiation protection devices, accessories, systems and procedures
available to you as the operator. WARNING Make sure that, when the system is
parked and connected to the mains, the system lock is in 0 (disabled) position
and the system lock key is removed to prevent accidental radiation emission.
Figure 2 System lock (system disabled)
Use only the prescribed dose necessary to perform a particular examination or treatment.
You should restrict access to the system in accordance with local regulations for radiation protection.
WARNING Interventional Procedures: this equipment is intended for procedures in which skin dose levels can be high enough in normal use to cause a risk of deterministic effects. It is vital that you strictly follow all safety directions for this type of procedure.
NOTE
For radioscopy events which are more than 0.5 seconds, radioscopy may continue for less than 0.1 second from the time the operator releases the control (Foot switch/Hand switch). While for radioscopy events of 0.5 seconds or less, the radioscopy may continue for less than 0.5 seconds from the time the operator releases the control (Foot switch/Hand switch).
2.11.1 Skin Dose Management
During prolonged interventional procedures skin dose levels can be high enough
in normal use to cause a risk of deterministic effects.
Risks and benefits for any given procedure should be evaluated clinically.
This system has several different selectable acquisition modes, each producing
different image quality by using different dose rates. The best acquisition
mode for the procedure should be used.
2.11.2 Radiation Guidelines
When performing radiation, the following rules should be followed: · Do not
radiate when not necessary. · Radiate for as short a time as possible. · Use
automatic dose rate control whenever possible.
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Radiation Safety
· Stay as far away as possible from the radiated object/X-ray source. · Wear
lead aprons and other protective clothing as appropriate. · Use badges to
monitor the radiation levels received in accordance with local regulations. ·
Use the laser aiming devices to determine the region of interest instead of
using fluoroscopy. · Use fluoroscopy (or roadmap) with low dose or normal dose
as much as possible instead of higher
dose levels and instead of other acquisition modes to reduce dose. · Collimate
as much as possible using the pre-indicators (on the LIH image). For more
information,
see Collimator and Shutter Adjustments in Last Image Hold (page 123). · Focal
spot to skin (object) distance should be kept as large as possible to reduce
the absorbed
dose. · Remove all supplementary obscuring objects from the primary beam,
including your hands. · In principle, the X-ray source should be placed under
the table to reduce exposure to scattered
radiation. · Take into account any unfavorable effects that may arise due to
materials located in the X-ray
beam, for example, the operating table. · The mobile view station should be
positioned so that the X-ray on indicator light on the mobile view
station is visible to all persons at all positions in the room.
2.11.3 Pediatric Radiation Guidelines
Use special care when imaging patients outside the typical adult size range.
When performing pediatric radiation, the following rules should be followed: ·
All rules mentioned in Radiation Safety (page 21). · Do not radiate when it is
not necessary. Use non-X-ray equipment when possible (e.g. ultrasound). ·
Remove any objects in the path of x-ray beam that are either not necessary to
execute the
procedure (e.g. mattresses, pillows, tubes, etc.) or that are not radiolucent.
· For small or thin objects, remove the detachable grid (see The C-arm Stand
(page 50)). · Select the correct procedure and anatomy or detailed procedure
for the anatomy (e.g. Skeleton –
Arm). · Choose the lowest dose (fluoroscopy with low dose) and lowest pulse
rate possible. · Place the detector as close as possible to the patient. · Use
collimation as much as possible to protect areas outside the region of
interest. Exclude eyes,
thyroid, breast, and gonads when possible. When possible, perform collimation
on the LIH. Combine independent shutters together with the iris to expose the
smallest area possible on the body part. · Use automatic dose rate control
whenever possible (Auto kV). When selecting manual kV, it is possible to
override the automatic dose rate control and lock the kV at the current value.
· Use the laser aiming device to determine your region of interest instead of
using fluoroscopy. · Instead of the right button, use the left (grey) button
on the hand switch (see Hand Switch (page 296)) or left pedal on the foot
switch (see Foot Switch (page 297) ). When storage is needed, this can be
enabled via the user interface. · Radiate for the shortest time possible, use
the LIH to review the anatomy rather than live fluoroscopy.
Design Features Important to Pediatric Imaging Procedure selection Dose level selection Pulse rate selection Removable grid Automatic dose control Laser aiming devices
Reference Changing the Default Examination Type (page 46) Making Fluoroscopy Images (page 111) Making Fluoroscopy Images (page 111) The C-arm Stand (page 50) Automatic kV/mA control (page 124) Laser Aiming Devices (page 62)
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Laser Light Radiation Safety
Testing Information Estimated patient dosimetry
Quality control instructions
Reference
· Patient Dose Information – Dose Rate With Grid (page 227)
· Patient Dose Information – Dose Rate Without Grid (page 245)
Maintenance (page 190)
Philips recommends reviewing generally available resources on pediatric
imaging before using the equipment for pediatric cases, such as the following:
· The U.S. Food and Drug Administration, Pediatric X-ray Imaging:
www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/
MedicalImaging/ucm298899.htm · The Alliance for Radiation Safety in Pediatric
Imaging, Image Gently: www.imagegently.org · The Society for Pediatric
Radiology: www.pedrad.org
2.12 Laser Light Radiation Safety
The laser light in the laser aiming devices should only be used under
supervision of a medically trained person with knowledge of the hazards
implied by the use of laser light.
It is the organization’s responsibility to fulfill the local safety
regulations regarding laser light radiation. WARNING The lasers must not be
switched on without purpose, and unnecessary exposure must be avoided. WARNING
Use of controls, adjustments, or procedures other than those specified in this
Instruction for Use may result in hazardous radiation exposure.
The lasers comply with FDA performance standards for laser products except for
the deviations pursuant to laser notice 50.
Detector Laser Aiming Device The detector laser aiming device consists of two,
Class 1 lasers which are integrated in the detector unit. WARNING Laser
radiation – Do not view laser beam directly with optical instruments. Class 1
laser product. Viewing laser output with certain optical instruments (for
example eye loupes, magnifiers and microscopes) within a distance of 100 mm
may pose an eye hazard.
Tube Laser Aiming Device WARNING Laser radiation – Do not view laser beam
directly with optical instruments. Class 1M laser product. Viewing laser
output with certain optical instruments (for example eye loupes, magnifiers
and microscopes) within a distance of 100 mm may pose an eye hazard.
Complies with IEC60825-1 and with FDA performance standards for laser products
except for the deviations pursuant to laser notice 50.
2.13 Labels and Symbols
This section describes the labels and symbols used on the equipment.
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2.13.1 Labels
The system has the following labels located as shown below.
Labels and Symbols
Figure 3 System overview
Legend
1
C-arm stand console
2
X-ray tank
3
C-arm stand back cover
4
Central labeling station
5
Front side of the mobile view station
Warning on the C-arm stand (1)
Figure 4 Transport position label
Label text Transport position
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Labels and Symbols
Figure 5 Ramp parked position label
Figure 6 Transport position – Down the ramp label Warnings on the C-arm Stand
Console (1) The following warning is displayed on the C-arm stand console. It
is only applicable to the USA, China, Japan, and Canada.
Label Text This X-ray unit may be dangerous to patient and operator unless
safe exposure factors, operating instructions and maintenance schedules are
observed.
Warnings on the X-ray Tank (2) The following warning is displayed on the X-ray
tank and is only applicable to USA, Canada, and Taiwan.
Label on the Front Cover of the C-arm Stand (3) The following label is displayed on the front cover of the C-arm stand and shows the position of the central labelling station.
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Labels and Symbols
Central Labeling Station (4) The central labeling station contains the FDA
certification labels of the following components: · X-ray control · Tank
housing assembly / X-ray tube · Image detection subsystem · Beam limiting
device · Laser product
Figure 7 Certification label
The central labeling station also contains the complete system configuration.
NOTE The appropriate labels on this panel must be updated when replacing
certified components.
Warnings and Labels on the Rear Side of the Mobile View Station (5) The
following labels are displayed on the rear side of the mobile view station.
Figure 8 System Label – A
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Labels and Symbols
Figure 9 System Label – B
Label Text Philips Philips Medical Systems Nederland B.V. Veenpluis 6 5684 PC
Best The Netherlands
Mains Rating
100 / 110 V~ 120 / 130 V~ 200 / 210 / 220 / 230 / 240 V~
Frequency – 50 / 60 Hz Single phase
Touch Screen Monitor Label
This box displays the manufacturing address of your system
Momentary 30 A 25 A 14 A
Long Time 15 A 13 A 8 A
Max. ()
0.1 0.2 0.6
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Labels and Symbols
Wired Foot Switch Label
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Remote Control Label
Labels and Symbols
Legend
1
Manufacturer
2
Date of manufacture
3
Part number
4
Serial number and viewpad type
5
Battery requirements
Your system may have additional labels as a result of local requirements.
2.13.2 Symbols
The system has the following symbols. For more information, refer to the
following Philips website: www.symbols.philips.com
Danger Voltage Dangerous voltages are present within the cabinet marked with
this symbol. Only trained personnel may remove the system cover, or otherwise
obtain access to system components. There are no user serviceable parts and
never attempt to repair this unit.
Refer to the Instruction Manual This symbol indicates that the accompanying
documents must be consulted.
Presence of Radio Frequency Transmitters This symbol indicates the presence of
radio frequency transmitters.
Information This symbol indicates information.
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Crushing Hazard: Hand This symbol indicates a warning that a hand crushing hazard exists.
Labels and Symbols
CE This symbol indicates that the equipment complies with the European
Communities regulation, the number of the notified body is printed.
The CE mark on the product denotes compliance with EU MDR Regulation (EU)
2017/745. The notified body number does not apply to the Restriction of the
Use of Certain Hazardous Substances in Electrical and Electronic Equipment
(RoHS) Directive.
Alternating Current This symbol indicates alternating current.
Equipotential Earth This symbol indicates the equipotential earth connector.
This connector allows a connection between the C-arm stand and the patient
support table or the earth (ground) bus bar provided by the hospital.
Protective Earth (Ground) This symbol indicates the potential earth terminal,
which is connected to conductive parts of Class 1 equipment for safety
purposes. This terminal should be connected to an external earthing system by
a protective earth connector.
On This symbol indicates an on switch for part of the equipment.
Off This symbol indicates an Off switch for part of the equipment.
Emergency Off This symbol indicates an emergency off switch for the C-arm
stand.
Canadian Standards Association This symbol indicates that the system has been
tested and certified by the Canadian Standards Association to comply with the
applicable U.S. and Canadian Standards.
TUV Rheinland certification mark This test mark is proof of compliance with
Canadian National standards and US National standards.
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Small Focal Spot The value next to the symbol indicates the size of the small focal spot.
Labels and Symbols
Large Focal Spot The value next to the symbol indicates the size of the large focal spot.
Direction of Grid This symbol indicates the direction of the grid lamella.
Laser This symbol indicates the presence of laser equipment.
Radiation This symbol indicates the presence of radiation (X-ray) equipment.
Transport This symbol indicates that the C-arm stand must be put in the
transport position before transporting it. For more information, see
Transportation (page 67).
Do Not Push This symbol indicates that you must not attempt to push the
equipment at the point where the label is situated, or at any point above.
Product Disposal This symbol indicates that the equipment contains material(s)
that are harmful to the environment if disposed of incorrectly.
Ingress Protection The IP code (International Protection code) indicates the
degree of protection provided by an enclosure. · IPX0: Protection against
ingress of solid foreign objects is not specified, and no protection against
ingress of water with harmful effects · IPX1: Protection against ingress of
solid foreign objects is not specified, and protection against
ingress of water with harmful effects from drips from above · IPX2: Protection
against ingress of solid foreign objects is not specified, and protection
against
vertically falling water drops when enclosure tilted up to 15 degrees. · IPX3:
Protection against ingress of solid foreign objects is not specified, and
protection against
ingress of water with harmful effects from spraying
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Labels and Symbols
· IP27: Protection against ingress of solid foreign objects greater than 12.5
mm in diameter, and protection against ingress of water with harmful effects
from temporary immersion
· IPX8: Protection against ingress of solid foreign objects is not specified,
and protection against ingress of water with harmful effects from immersion.
Manufacturer This symbol identifies the medical device manufacturer. The date
of manufacture, as well as the name and address of the manufacturer, can be
combined in one symbol.
Date of Manufacture This symbol indicates the date when the medical device was
manufactured.
Catalogue Number This symbol indicates the manufacturer’s catalogue number so
that the medical device can be identified. This symbol may be shown without
the enclosure.
Serial Number This symbol indicates the manufacturer’s serial number so that a
specific medical device can be identified. This symbol may be shown without
the enclosure.
Consult the Instructions for Use This symbol instructs the user to consult the
Instructions for Use.
Caution This symbol indicates that you should use caution and consult the
accompanying documents.
Battery This symbol indicates the number and type of batteries used for the
device.
FCC Declaration of Conformity This symbol indicates that the product conforms
to Federal Communications Commission limits on electromagnetic interference.
KCC Declaration of Conformity This symbol indicates that the product conforms
to the requirements of the Korea Certification Standard.
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Cardiac Extension This symbol indicates that the cardiac extension is installed on your system.
Labels and Symbols
Vascular Extension This symbol indicates that the vascular extension is installed on your system.
Regulatory Compliance Mark for Australia and New Zealand This symbol indicates
that the equipment complies with regulations in Australia and New Zealand.
Class II Equipment This symbol indicates that the equipment meets the safety
requirements specified for Class II equipment (without the use of protective
earth connection).
Prescription Device In the United States, Federal law restricts this device to
sale, distribution, and use by, or on the order of, a physician.
Country of Manufacture This symbol indicates the country of manufacture of
products.
Medical Device This symbol indicates item is a medical device.
Unique Device Identifier This symbol indicates the unique device identifier.
Order Number This symbol indicates the order number.
Model Number This symbol indicates the model number or type number of the
product.
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Information Regarding Substances in the System
2.14 Information Regarding Substances in the System
REACH Declaration REACH requires that Philips Medical Systems provides
chemical content information for Substances of Very High Concern (SVHC) if
they are present in amounts above 0.1% of the product weight. Components with
electric or electronic equipment may contain phthalates above the threshold
(for example, bis(2-ethyl(hexyl)phthalate), CAS nr.: 117-81-7). Philips
Medical Systems is still in the process of investigating its supply chain to
further establish which components contain phthalates. The SVHC list is
updated on a regular basis. For the latest list of products that contain SVHC
above the threshold, go to the following website:
www.philips.com/about/sustainability/reach
Perchlorate Perchlorate material is present in lithium coin cells or batteries
that are used in the system. Special handling may apply. For information, go
to the following website:
www.dtsc.ca.gov/hazardouswaste/perchlorate
Product Recycling Passport Detailed information on product recycling is
available in the Product Recycling Passport:
www.healthcare.philips.com/main/about/sustainability/recycling
California proposition 65 requires Philips Medical Systems (PH) to provide
reasonable safety warning Information when substance released is above safer
harbor level. For information, go to the following website: WARNING
California’s Proposition 65 requires Philips Medical Systems to provide
reasonable safety warning Information when a released substance is above safe
harbor levels. The internal components of this product may contain substances
that, when exposed, are known to the State of California to cause cancer or
reproductive harm. Based on the risk assessment performed by Philips, there is
no risk or low risk to patient or hospital staff. Service personnel may be
exposed to internal components while servicing the equipment. For information
about risks to service personnel, refer to the service documentation.
For more information on California’s Proposition 65, see the following
websites
· www.philips.com/about/sustainability · www.P65Warnings.ca.gov
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User Interface
3 Installation
This section describes how to interact with the system’s user interface, and
how to configure system parameters.
3.1 User Interface
The following provides a basic introduction to the user interface on the
mobile view station and the Carm stand. More advanced controls are described
in detail later in this manual. Tooltips provide help and information about
buttons and other items in the user interface. When enabled, tooltips appear
after positioning the pointer over an item in the user interface.
3.1.1 Mobile View Station
This section describes navigation and the common user interface elements of
the mobile view station.
Navigation Use the touch pad and left button on the mobile view station
console to control the pointer on the screen of the examination monitor and
the reference monitor (see About the Zenition 30 System (page 49)).
1
Figure 10 Touch Pad
Legend 1 2
Touch pad Left button
Use the pointer to click buttons or select items on the screen: · Move the
pointer over a control or item. · Press the left button on the mobile view
station console to activate the control or select the item.
To assist you, the appearance of a button changes to indicate it is being
clicked, and a selected item is highlighted (if appropriate).
Dragging Items on the screen, like sliders or controls, can be dragged when appropriate. To drag an item on the screen, position the pointer over the item and drag it by moving it with the pointer while keeping the left button pressed.
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Touch Screen Functionality (optional) The examination monitor has touch screen
functionality allowing you to perform actions normally requiring the touch pad
(clicking buttons, selecting items, dragging items) by touching the screen
directly. Using the touch screen functionality, items on the screen can be
dragged by touching them and dragging. The item is released when the screen is
no longer touched. CAUTION Using excessive force and/or sharp objects to
operate a touch screen is likely to result in damage to the screen. Touch
screen functionality is not available for the reference monitor.
Entering Text When a text field is selected, text can be entered using the
keyboard on the mobile view station console. To make a correction when
entering text use the Backspace or Delete key on the keyboard. When several
text fields are available, press the Tab key on the mobile view station
console after completing a field to automatically select the next field in the
dialog box.
Accept
Pressing the Accept button on the mobile view station console is the same as
clicking the highlighted (active) button on the examination monitor.
Highlighted (active) buttons are displayed with a yellow outline. It is useful
as a shortcut to perform the associated action.
Undo
Some actions can be undone using the Undo button on the mobile view station
console. Pressing the Undo button undoes the previous action, removes a
selected graphical element (such as annotation), or resets the text of a field
to original value before editing Only one previous action is undone when the
Undo button is pressed. A series of several actions can be undone by pressing
the Undo button repeatedly.
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Common User Interface Elements
User Interface
Figure 11 Mobile view station interface (administration screen) on the examination monitor
Legend 1 2 3 4 5
List selection panel Control panel Status indicator Patient list Selected patient
6
Column headings
7
Notification area
8
Global tools
9
Top bar menu
List Selection Panel
The task navigation panel allows you to move between the two available lists:
· To see the scheduled patient list, click Schedule. · To see the patient list
for review, click Review.
Control Panel The task control panel allows you to select a function to perform within each task.
Patient List Each line in the patient list represents a patient examination.
When selected, an examination is highlighted.
The patient list includes all patients available for type of examination:
Schedule or Review.
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The Schedule and Review lists have independent patient lists.
Status Indicator The status indicator displays status information about a patient examination. For more information, see Managing Patients and Examinations (page 91)
Column Headings Clicking on a column heading sorts the patient list on that field. Click on the field again to reverse the sort order. The order in which columns are sorted is indicated by an arrow in the sorted column header.
Notification Area The notification area displays warning and messages.
Global Tools In the Review task, additional tools are available. These tools
are available whenever images are
displayed, except when live images are displayed.
Tool
Export
Description
Use this tool to export data to another location. For example, exporting data
to a PACS. For more information, see Exporting Images to a Network Location
(page 163).
Save
Use this tool to save data to USB, DVD or CD. For more information, see Saving Images to Local Media (page 164).
Use this tool to print data on a DICOM network printer. For more information, see Printing Images (Option) (page 166).
Job Viewer
The job viewer contains a list of queued transfer jobs. Use this tool to open the job viewer, where you can see the status of export, save, or print jobs. The icon displayed in the global tools changes to indicate the status of transfer jobs. For more information, see Viewing Transfer Jobs in the Job Viewer (page 167).
Top Bar Menu The top bar menu provides access to additional functions like the
job viewer, wireless network information, password management, system setup,
remote assistance, user profile and help information.
3.1.2 C-arm Stand
This section describes the user interface elements of the C-arm stand.
C-arm Stand Controls You can switch the C-arm stand On and Off using buttons
on the C-arm stand console.
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You can also adjust the height of the C-arm using the height movement buttons
on the C-arm stand. For more information, see System On/Off (page 81) and
Height Movement (page 79). For an overview of all the buttons available on the
C-arm stand, see C-arm Stand Console (page 293) and C-arm Stand Height
Movement (page 295).
C-arm Stand Touch Screen The C-arm stand is controlled using a touch screen.
The C-arm stand touch screen allows you to tap buttons, and select and drag
items by touching the screen directly. For more information, see Operation
(page 67). For an overview of all the functions available on the C-arm stand
touch screen, see C-arm Stand Touch Screen (page 294). CAUTION Using excessive
force and/or sharp objects to operate a touch screen is likely to result in
damage to the screen. Functions on the C-arm stand touch screen activate when
your finger is released from the touch screen. The amount of force used to tap
controls on the C-arm stand touch screen is irrelevant.
3.2 System Setup
You can change some system parameters using the System Setup dialog box on
MVS. The System Setup dialog box allows you to change several system
parameters. These functions are described in the following pages. All changes
made using the System Setup dialog box take effect immediately. The System
Setup dialog box is opened from the administration screen. You can open the
administration screen by pressing the Administration button.
To open the System Setup dialog box from the administration screen, click
System in the top bar menu and select System Setup.
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Figure 12 System Setup dialog box
Legend
1
Physician list
2
Current date
3
Current time
4
IP addresses
5
IQ test image
6
Language
7
Instructions for Use language
8
Default examination type (Adult)
9
Default anatomy/detailed procedure for Adult
10
Default examination type (Pediatric)
11
Default anatomy/detailed procedure for Pediatric
12
External video input
Physician List The physician list allows you to view a list of all physicians listed in the system. You can add or delete physicians from the list. For more information, see Modifying the Physician List (page 42).
Current Date The current date is recorded with all acquired images. You can change the current date. For more information, see Modifying the Date and Time (page 43).
Current Time The current time is recorded with the current date for all acquired images. The current time is set either manually or by a time server. For more information, see Modifying the Date and Time (page 43).
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IP Addresses These are the IP addresses assigned to the system. NOTE The IP
addresses are set during system installation and cannot be modified using the
System
Setup dialog box.
IQ Test Image This allows you to choose the IQ test image to display. For more
information, see Displaying the IQ Test Image (page 44).
Language This is the language used for the system user interface. For more
information, see Changing the User Interface Language (page 45).
Instructions for Use Language This is the language used when displaying the
electronic Instructions for Use. For more information, see Electronic
Instructions for Use (page 90) and Changing the Instructions for Use Language
(page 45).
External Video Input This is the selected type of external video input signal.
External video viewing is an optional function. For more information, see
External Video (page 65).
Default Examination Type (Adult) This is the default examination for adults,
used in conjunction with the default anatomy/detailed procedure for adults.
For more information, see Changing the Default Examination Type (page 46).
Default Anatomy/Detailed Procedure This is the default anatomy/detailed
procedure for adults, used in conjunction with the default
procedure/examination type for adult. For more information, see Changing the
Default Examination Type (page 46).
Default Examination Type (Pediatric) This is the default examination for
pediatric, used in conjunction with the default anatomy/detailed procedure for
pediatrics. For more information, see Changing the Default Examination Type
(page 46).
Default Anatomy/Detailed Procedure This is the default anatomy/detailed
procedure for pediatrics, used in conjunction with the default
procedure/examination type for pediatrics. For more information, see Changing
the Default Examination Type (page 46).
3.2.1 Modifying the Physician List
You can modify the physician list to edit, add, or delete physician names. You
can store up to 100 physician names in the list. A warning message is
displayed when this limit is reached. When the list is full, you cannot add
new physicians, but you can delete physicians from the list to create space. 1
In the administration screen, click System and select System Setup.
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The System Setup dialog box is displayed, including the physician list. 2 To
add a new physician, do the following:
a click Edit. The Physician dialog box is displayed.
b Enter the new physician’s name in the Physician field. c To close the
Physician dialog box without adding the new physician, click Cancel. d To save
the new physician in the list, click Add physician.
The new physician’s name is added to the list and the Physician dialog box is
closed. 3 To edit an existing physician’s name, do the following:
a Select the physician in the physician list. b click Edit.
The Physician dialog box is displayed. c Edit the physician’s name in the
Physician field. d To close the Physician dialog box without saving your
changes, click Cancel. e To save the change, click Edit.
The selected physician’s name is changed in the physician list and the
Physician dialog box is closed. 4 To delete a physician, do the following: a
Select the physician in the physician list. b click Edit. The Physician dialog
box is displayed. c To close the Physician dialog box without deleting the
selected physician, click Cancel. d To delete the selected physician, click
Delete. The selected physician is deleted from the list and the Physician
dialog box is closed.
3.2.2 Modifying the Date and Time
You can change the date and time in the system if they are incorrect for any
reason. The dates and times stored with existing examinations and images are
not affected when you change the date and time in the system. 1 In the
administration screen, click System and select System Setup.
The System Setup dialog box is displayed. 2 Click the calendar icon beside the
Date field, and select the desired date.
3 In the Time box, enter the correct time using the 24-hour format (hh:mm). If
the time server is enabled at system installation, the date and time are
automatically synchronized after startup when a connection with the time
server is established.
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The time and date is synchronized hourly when the system is connected to the
time server. Any manually entered date and time is overwritten when the date
and time are automatically synchronized. 4 To close the System Setup dialog
box without changing the date and time, click Cancel. 5 To save your changes,
click Apply. The date and time are changed and the System Setup dialog box is
closed.
3.2.3 Displaying the IQ Test Image
You can use the IQ test image to check the monitor settings and to set up the
printer. If you are using external video on the reference monitor, the IQ test
image is not displayed on this monitor. 1 In the administration screen, click
System and select System Setup.
The System Setup dialog box is displayed. 2 In the System Setup dialog box,
select the desired IQ Test Image to use. 3 Select the desired Position for the
IQ test image on the screens.
Three positions are available.
Figure 13 IQ test image positions
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Legend
1
Full Screen (1280 x 1024 pixels)
2
Clinical (1024 x 1024 pixels)
3
Centered (1024 x 1024 pixels)
4 To display the IQ test image, click Show.
The selected IQ test image is displayed on both the examination and reference monitors. 5 To display other available IQ test images, press Previous or Next on the mobile view station.
The previous or next image in the IQ Test Image list is displayed. 6 To stop displaying the IQ test image, press Undo on the mobile view station.
7 To close the System Setup dialog box, do one of the following: · To close
the dialog box without saving any changes made to other settings, click
Cancel. · To close the dialog box and save changes made to other settings,
click Apply.
If an image was parked on the reference monitor, the parked image is displayed
again when the IQ test image is removed.
For more information, see DIN6868-157 Compliance Testing (page 290)
3.2.4 Changing the User Interface Language
You can change the language used on the system.
1 In the administration screen, click System and select System Setup.
The System Setup dialog box is displayed.
2 In the Language list in the System Setup dialog box, select the desired language.
The Language list displays all available languages. The language that you select is used on the mobile view station and C-arm stand for the rest of the session.
NOTE
When the system is restarted, the user interface is displayed in the default language, which is configured during installation. To change the default language, contact Service or your hospital administrator.
After changing the language, the following items are not translated: · Information received from the HIS/RIS. · Text entered by the operator.
3.2.5 Changing the Instructions for Use Language
You can change the language used to display the Instructions for Use on the
system.
1 In the administration screen, click System and select System Setup. The
System Setup dialog box is displayed.
2 Select the desired IFU Language.
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3 To close the System Setup dialog box without changing the Instructions for
Use language, click Cancel.
4 To change the Instructions for Use language, click Apply.
The electronic Instructions for Use will be displayed in the selected language when opened.
The new language setting is not saved.
NOTE
When the system is restarted, the user interface is displayed in the default language, which is configured by the Service engineer during installation. To change the default language, contact Service.
3.2.6 Changing the Default Examination Type
You can change the default examination type by selecting the default procedure
and default anatomy/ detailed procedure.
1 In the administration screen, click System and select System Setup. The
System Setup dialog box is displayed.
2 Select the desired procedure in the Default exam type list.
The list displays all available procedures. The selected procedure becomes the
default setting for new examinations, and it remains the default setting after
the system is restarted. 3 Select the desired anatomy/detailed procedure in
the default anatomy list.
The list displays all available anatomies/detailed procedures. The selected
anatomy/detailed procedure becomes the default setting for new examinations,
and it remains the default setting after the system is restarted.
NOTE
When the system is restarted, the user interface is displayed in the default examination type, which is configured by the Service engineer during installation. To change the default examination type, contact Service.
3.3 Customizing
Some system parameters can be changed during installation to optimize
performance during special applications or to meet personal preferences. To
change these parameters ask the local Service Organization.
Hospital / User
General system parameters Hospital name Language IFU Language Date format Units of Measure Units of Weight Units of Height Displayed identification Accession number Contrast step 1
Settings Maximum 30 characters Allows you to select the language of the user interface Allows you to select the language of the electronic Instructions for Use yyyy-Mmm-dd, dd-Mmm-yyyy, or Mmm-dd-yyyy 0.1 mm or 0.01 inch kg or lb cm / feet and inches Patient ID (default) or Accession number Read-only (default) or Editable 120%, range 50% – 150%
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General system parameters Contrast step 2 Contrast step 3 Brightness step 1 Brightness step 2 Brightness step 3 Default Patient Type Enable Automatic Parking Display Ideographic Name CFDA Compliance CO2 (trace white) selection Auto Electronic Blanking Audible signal normal dose Audible signal Single Shot Dose warning threshold Auto high level reset Dose selection RC Mode Key Collimator lines visible Close examination Export to Media
Settings 135%, range 50% – 150% 150%, range 50% – 150% 106%, range 50% – 150% 113%, range 50% – 150% 120%, range 50% – 150% Adult, Pediatric No, Yes No, Yes Yes, No Disable, Enable On, Off Off, Low level beep, One beep at start At begin, At end 1000 mGy, range 1 – 9999 mGy No, Yes Disable, Enable No, Yes Hidden, Visible Disable, Enable
System
General system parameters Image rotation angle (°) Default Shutters position
angle (°) Couple Shutters button Auto Shutter Positioning CO2 (trace white)
selection Auto Electronic Blanking Audible signal normal dose Audible signal
Single Shot Dose warning threshold (mGy) Auto high level reset Mode key on
remote control Collimator lines visible Close examination Export to Media
DICOM
· DICOM Export Targets · DICOM Printer Targets · Worklist Query Definition ·
DICOM Worklist Management · DICOM MPPS Server · DICOM Structured Dose Report ·
DICOM Multimodality Viewer
Settings 0, 90, 180, 270 0, 90 Visible, Hidden Enable, Disable Enable, Disable On, Off Off, Low level beep, One beep at start At begin, At end 1000 mGy, range 1 – 9999 mGy No, Yes Acquisition Mode, Dose Selection No, Yes Hidden, Visible Disable, Enable
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Anatomy / Detailed procedure Names Anatomy and detailed procedure names can be changed, but parameters stay the same.
Procedure Name Skeleton Vascular Cardiac Pain Endoscopy Urology
Settings Skull, Thorax, Spine, Pelvis/Lumbar Spine, Arm and Hip/Leg Cerebral, Aortic Arch, Abdominal, Arm, Leg and Bolus Chase Pacemaker Head, Neck, Spine, Pelvis/Lumbar Spine, Arm and Hip/Leg ERCP, Esophagus and Bronchus Kidney, Lithotripsy, Bladder and Ureterography
Examination Activation This function allows you to make changes in the examination settings permanent or restores the previously used examination settings. Select the required action in the setting area and click OK to continue or click Cancel to go back to main menu
System parameters Make examination settings permanent
Restore previously used examination settings
Settings Yes, No Yes, No
Electro Magnetic Brakes Setting This setting allows you to customize the time,
the brakes remain applied, when brakes are applied from the stand. The
settings are applied to angulation, rotation and longitudinal brakes on the
C-arm.
NOTE The settings are not applicable in case the brake is released from the
surgeon side control.
Reference Re-Engage Time in minutes
Settings Re-Engage Brakes after 1 to 5 minutes of release
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About the Zenition 30 System
4 System Overview
This section provides an overview of the system, its main components,
configurations, and options.
4.1 About the Zenition 30 System
The system comprises two main components: the C-arm stand and mobile view
station.
3 4 5
1
6
9
Figure 14 System components
Legend
1
Mobile view station
2
Examination monitor
3
Reference monitor
4
Detector
5
C-arm stand touch screen
6
C-arm stand
7
C-arc
8
Collimator
9
X-ray tank
4.2 Composition
This section covers composition of the C-arm stand and mobile view station.
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4.2.1 The C-arm Stand
X-ray Tank The X-ray tank houses the X-ray tube, which has a fixed anode for
increased X-ray penetration and longer X-ray times. A built-in, additional,
beam filter (0.1 mm Cu and 2 mm Al) reduces patient skin dose. Active oil
cooling is used in the X-ray tank, for longer X-ray times.
Collimator The collimator limits the X-ray beam to the actual field of view of
the detector. Lead shutters can be independently moved and rotated to avoid
direct radiation on the detector and reduce scattered radiation.
Detector The detector provides detector zoom modes, and has a detachable X-ray
grid. The grid removes part of the scattered radiation, improving the contrast
in the image. Removing the grid may negatively affect the image quality. In
some cases, such as small or thin objects where there is less scatter
radiation, the influence of the grid is limited. Removing the grid in this
situation reduces the radiation dose for the patient and may provide a small
degree of contrast improvement.
In case of Pediatric patient, it is recommended to remove the grid. NOTE The
grid is attached with screws which can be tightened/loosened by hand.
The presence or absence of the grid is clearly visible to the operator.
WARNING Ensure the detector grid is mounted for the next procedure.
Figure 15 X-ray grid
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Hand Switch The hand switch, which can be stored on either side of the C-arm stand, is used to activate a range of X-ray and acquisition modes, such as fluoroscopy, roadmap, subtract, trace, run, and single shot.
Figure 16 Hand switch
You can also use the system with foot switches. For more information, see
Wired Foot Switch (page 60).
Movements and Brakes The C-arm is counterbalanced. You can lock and unlock
movements of the C-arm via electronic switches except the swivel movement,
which can be manually controlled. The electronic switches are present on the
stand top panel and are also available on the detector side. The height
movement is motor-driven which can be controlled by switches provided on stand
top panel.
The steering handles are coupled and control the rear wheels. The front wheels
swivel freely. All wheels are provided with cable deflectors. The C-arm stand
is equipped with a brake. See Transportation (page 67) for more information
about steering and braking with the C-arm stand.
The C-arm movement brakes are color-coded for identification. See C-arm Brakes
and Movements (page 74) for details.
An overview of C-arm movements is provided in the following figures.
Figure 17 C-arm rotation (left) and angulation (right)
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Figure 18 C-arm height (left) and longitudinal (right) movement Figure 19 C-arm swivel movement
The C-arm Stand Console The C-arm stand console contains the C-arm stand off,
C-arm stand on / System on, and Emergency off buttons.
The motorized height movement is controlled using buttons on either side of
the C-arm console. For more information, see C-arm Stand Height Movement (page
295).
For an overview of the C-arm stand console buttons, see C-arm Stand Console
(page 293).
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The C-arm Stand Touch Screen
Composition
Figure 20 C-arm stand touch screen movements
The C-arm stand touch screen controls all functions related to performing
fluoroscopy and exposure. For more information on the functions available on
the C-arm stand touch screen see Operation (page 67). For an overview of the
C-arm stand touch screen controls see C-arm Stand Touch Screen (page 294).
Figure 21 C-arm stand touch screen layout
Legend
1
Function area
2
Image area
3
Image toolbar area
4
Header area
5
Image review toolbar
6
Status area
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Function Area System settings, displayed in the Function area can be changed
using the expanders or by tapping buttons to toggle functions on or off.
This area contains buttons and drop-down lists to control settings for: ·
Examination type · Fluoroscopy
Mode Dose Pulses Store Reduce Blur Reduce Noise · Exposure Mode
Pulses Store · Detector Zoom · ClearGuide · Detector laser · Tube laser
(if installed) · kV manual/auto · C-arm position memory (if installed)
Image Area The image area displays a monochrome copy of the live image
displayed on the examination monitor, scaled to fit in the available space on
the C-arm stand touch screen including appropriate text, indicators,
positioning and rotation controls, and shutter and collimator positions.
Image Toolbar Area The image toolbar area displays image manipulation tool
buttons appropriate to the task being carried out.
Header Area The header area provides access to system tasks, system help and
tooltips.
Status Area This part of the display shows information about:
· The acquisition patient · Warnings and system messages · The radiation
status · Heat indication · C-arm positioning (option) · kV value · Average mA
value
Value for both the left and right button/pedal on the hand switch and foot
switch is displayed. · Dose display:
Total Cumulative Dose is displayed before and after X-ray and during Single
Shot. Units: mGy. The current average dose rate is displayed during X-ray
on. Units: mGy/min. The values represent the dose at 30 cm from the detector
entrance surface. · Cumulative time display. The format for the cumulative
time depends on the selected display mode:
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If IEC display mode is selected then minutes and seconds are displayed using
the minutes/ seconds format/range: 0:00-999:59.
If HHS display mode is selected then minutes are displayed using the
minutes/decimal minutes format/range: 0.0-999.9.
System Messages Warnings and system messages are displayed in the status area
on the C-arm stand touch screen.
For more information about Warnings and system messages, see System and Error
Messages (page 189).
The C-arm Stand Connector Panel The C-arm stand connector panel is located on
the front left-hand side of the C-arm stand.
3 4
5
Figure 22 C-arm stand connector panel
Legend
1
Foot switch connector
4
2
Touch Screen Module connector
5
3
System lock
For more information, see the following sections: · Connecting the Wired Foot Switch (page 187) · Equipotential Ground Connection (page 19) · Connecting the System (page 81)
Mobile view station connector Equipotential earth connection
Energy storage unit The system has a energy storage unit located in the C-arm stand to provide the additional power required during X-ray pulses. The system requires mains power to operate and cannot operate using the energy storage unit alone.
System Lock The system lock prevents operation of the C-arm stand by unauthorized personnel. The lock is controlled by a key. The key can be removed when in the 0 position.
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When locked using the key, the system will: · Disable X-ray · Display a
warning on the C-arm stand touch screen.
4.2.2 The Mobile View Station
Monitors The mobile view station is equipped with either two standard monitors
or two high-brightness monitors.
Examination monitor: · Live imaging · Roadmaps · Outlining (optional) · Dose
display · Last image hold (LIH) images · Scheduling examinations · Reviewing
examinations · Worklist · Dose report · System setup screen · IQ test image ·
Configuring user profile · Touch-screen functionality (optional) ·
Instructions For Use
CAUTION Using excessive force and/or sharp objects to operate a touch screen
is likely to result in damage to the screen.
Reference monitor: · Reference images · External video source · Multi-Modality
Viewer · IQ test image · Field service application
The monitors can be swivelled by 180 degrees for ease of viewing, either for
the operator at the mobile view station console, or for the physician at the
tableside, and to allow the mobile view station to be positioned with the rear
(open side) pointing away from the patient. You can also adjust the height of
the monitors. For more information, see Monitors (page 87).
Password Protection Patient data on the mobile view station can be protected
from unauthorized access with a password. Patient data cannot be viewed or
accessed until the user name and correct password is entered.
NOTE It is always possible to create an emergency examination and make
acquisitions for a new patient without entering the user name and password.
User names and passwords are set by the hospital administrator during
installation with support from Service. After installation, Service or a
hospital administrator, can change the user name and password or disable
password protection altogether (it can be enabled again at a later date). For
more information about system security, see Security and Privacy Provisions
(page 285).
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Using the Mobile View Station The mobile view station can be used for viewing,
archiving and post-processing purposes. You can also prepare for the next
procedure by selecting the examination type for the acquisition patient while
the mobile view station is disconnected from the C-arm stand.
Steering The mobile view station brake has release/apply positions and a wheel
swivel locked position for easy transportation. All wheels are provided with
cable deflectors.
Controls, Displays and Indicators The mobile view station controls all
functions for managing patients, examinations and images. The console consists
of a key panel and button controls. The functions of the controls are
described in Operation (page 67). For an overview of the console, see Mobile
View Station Console (page 292).
X-ray On Indicator Light The X-ray on indicator light is on when the system is
emitting X-rays. It is located above the monitors at the top of the monitor
support column.
Infrared Receiver Indicator The infrared receiver is located just above the
monitors. A green indicator light flashes when a command is received from the
remote control.
Storage Compartment The mobile view station includes an open storage
compartment on the rear side. The maximum permitted load for the storage
compartment is 5 kg.
4.2.3 Mobile View Station Connector Panel
The mobile view station connector panel is located on the rear of the mobile
view station.
Figure 23 Mobile view station connector panel
Available Connectors The mobile view station connector panel provides the
following connectors:
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Figure 24 Mobile view station connector panel – available connectors
Legend
1
Hospital network port
2
Service connection port
3
Mains connection indicator
4
USB connectors
5
Video input connectors (optional)
6
DVI out (examination monitor)
7
DVI out (reference monitor)
8
Warning light connector
The warning light connector allows the system to be connected to indicators
inside or outside the examination room. These external indicators are not part
of the Zenition 30 system.
WARNING Do not touch the pins of the mobile view station cable or the central
pin of the video/USB connectors when operating the patient.
NOTE All connections made to external equipment that has a connection to the
mains network shall be made in compliance with IEC60601-1-3rd edition.
CAUTION Do not connect the system to network outputs that provide Power over
Ethernet (PoE).
Connecting External Equipment You can connect additional monitors (not
supplied) to the mobile view station using the DVI outputs on the connector
panel. Additional monitors should be connected according to IEC 60601-1 table
I.1.
When placing additional monitors inside the operating theater: · It is
preferable to use monitors of the same type as those that are used in the
system, and that
comply to IEC 60601-1. When such monitors are used in the same room as the
system, a normal DVI cable can be used. · If another type of monitor is used,
which does not comply with IEC 60601-1 but does comply with IEC 62368, then a
galvanic separation device is mandatory. · When the additionally placed
monitors are used for diagnostic purposes, their performance should be
validated for that use.
When placing additional monitors outside the operating theater, a galvanic
separation device is mandatory.
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Options
When connecting equipment to the USB or Video in connection, a galvanic
separation device is mandatory if the external equipment is connected to the
supply mains network. The DVI interface can be connected to the DVI interface
of devices that comply with IEC 60601-1.
4.2.4 Spacers
The minimum source-skin distance is 20 cm. The spacer safeguards a minimum
source-skin distance. In some countries a 30 cm spacer is required. For those
countries where it is applicable, the appropriate spacer is delivered with the
system. WARNING There must always be a spacer installed to safeguard the
minimum statutory source-skin distance.
Figure 25 Spacers for minimum source-skin distance
Legend
1
30 cm spacer
2
20 cm spacer
4.2.5 Wireless LAN
The Wireless LAN option provides the ability to maintain a network connection
with your facility’s RIS/HIS without requiring a physical connection (network
cable).
This increases the flexibility and mobility of the system when transferring
patient data between the system and networked archives such as a PACS.
4.3 Options
This section provides information about optional aspects of the system. Not
every function described here may be installed on your system. WARNING Only
the options and equipment delivered by Philips Medical Systems may be used in
conjunction with the Philips. The use of accessory equipment not complying
with the equivalent safety requirements of this equipment may lead to a
reduced level of safety in the resulting system. Consideration relating to the
choice shall include the following:
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· Use of the accessory in the patient vicinity. · Evidence that the safety
certification of the accessory has been performed in accordance with
the IEC 60601-1.
4.3.1 Wired Foot Switch
The wired foot switch is used to activate a range of X-ray and acquisition
modes, such as fluoroscopy, roadmap, subtract, trace, run, and single shot.
Figure 26 Wired foot switch
4.3.2 Paper Printer
You can print video images by using printer for printing on paper.
Figure 27 Printer
4.3.3 Position tracking
If the position tracking option is installed, the C-arm position is shown in
the status area of the C-arm stand touch screen. The system shows the current
C-arm rotation, angulation, height and longitudinal positions. For more
information see Position Tracking (page 176)
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4.3.4 Encrypted PC
This option helps to secure the patient data.
4.3.5 Spring Bow
A spring bow option is available and can be used to hold the sterile cover of
the C-arm in position, while allowing free movement of the C-arm. Some sterile
covers do not require you to use the spring bow. You should check which
sterile covers are in use in your hospital and whether you need to use the
spring bow. For more information, see Spring Bow (page 182) and Fitting the
Spring Bow (page 182).
4.3.6 Touch Screen Module (TSM)
Touch Screen Module (TSM) is used to control C-arm stand functions. The TSM
allows you to tap buttons; and select and drag items by touching the screen
directly. TSM reduces dependency of the operator for medical procedures
5 4
1
2 3
Figure 28 Touch Screen Module (TSM)
NOTE Images are only for reference (or similar to this).
Legend
1
C-arm
2
C-arm stand
3
Touch Screen Monitor Connector
4
Operation Table
5
Touch Screen Module (TSM)
To view list of functions that the TSM supports, see C-arm Stand Touch Screen (page 294) For more information, see the following sections:
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· Touch Screen Module (TSM) (page 183) · Touch Screen Gestures (page 299)
4.3.7 Laser Aiming Devices
Your system can have up to two laser aiming devices: · Detector laser aiming
device (option) · Tube laser aiming device (option)
Using laser light, the laser aiming device projects a cross on the patient.
The center of the projected cross corresponds with the center of the X-ray
beam. It is used to: · Position the C-arm, minimizing the amount of radiation
for the patient and staff. · Quickly and precisely align objects with the
center of the X-ray beam.
The minimum working distance is about 20 cm from the detector.
Detector Laser Aiming Device The detector laser aiming device consists of two
lasers, which are integrated in the detector and produce a cross on the X-ray
tank. The lasers are switched on and off using the Detector Laser toggle
button on the C-arm stand touch screen.
Figure 29 Detector laser aiming device
WARNING Laser radiation. Do not view directly with optical instruments. Class
1M laser product. NOTE The detector laser aiming device must not be used for
positioning if the patient is positioned
closer than 20 cm to the detector. It will not produce a cross if it is too
close.
Tube Laser Aiming Device The laser aiming device is built into the X-ray tank.
It projects a cross hair on to the detector entrance screen. It is switched on
and off with the Tube Laser toggle button on the C-arm stand touch screen. For
more information, see Laser Aiming Devices (page 175).
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4.3.8 Remote Control
The remote control is a device using infrared light. It allows some image
handling functions to be controlled from the operating position.
The IR transmitter is located on the front end of the remote control and, if
obstructed, no signals are transmitted. The IR receiver is located on top of
the mobile view station, between the examination monitor and the reference
monitor. A light on the receiver indicates that the selected command has been
received. For a description of the buttons, see Remote Control (page 298).
The operation of the remote control is not affected, when placed in a
transparent sterile cover. It is battery-powered and the batteries must be
replaced regularly. For more information, see Replacing and Charging Batteries
(page 200).
Figure 30 Remote control
WARNING Infrared signals from the remote control may interfere with other
infrared-controlled equipment in the same room, causing uncontrolled behavior.
Before using the remote control in a procedure, check that no interference can
be caused to other equipment. WARNING Identical remote controls are
interchangeable. Therefore, do not use the remote control when more than one
system is in use in the same room. If several systems are in the same room,
remote control commands for one system may initiate actions on another system,
causing uncontrolled behavior.
CAUTION It is recommended to remove the batteries if the remote control will
not be used for some time.
4.3.9 Surgeon Arm
This option facilitates control of C-arm movements from the surgeon side. The
C-arm movement can be performed along three axis namely Rotation, Angulation
and Longitudinal.
4.3.10 Warning light connection
The interface for X-ray On/Off, System On/Off allows the system to be
connected to the indicators inside or outside the examination room. If
connected, this option enables an indicator to light up every time the system
is switched on and/or when X-ray is used.
4.3.11 Video converter
The video converter option is used to convert external video in signal (SDI,
DVI-D or S-video) to DVI-D signal. Also, it converts PAL or NTSC to DVI-D. For
more information, see Video Converter in Options (page 272)
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4.3.12 DICOM/IHE Interface
There is an interface between the mobile view station and the
hospital/departmental network. It complies with the DICOM 3.0 standard.
The DICOM interface allows images of a completed examination to be exported to
a network storage device or sent to a network printer for output. Available
formats are: · DICOM SC (Secondary capture, with and without text) · DICOM XA
(X-ray Angiographic, Unprocessed, processed without Mask and Processed with
Mask)
Images can be selected for export or print while the system is not connected
to the network. These images will be held in a queue and sent when the system
is reconnected to the network. NOTE The examination dose report can also be
exported or printed (see Exporting, Saving, and
Printing (page 161)). For more details, refer to the DICOM conformance
statement.
The DICOM package also provides the following functionality for the DICOM
interface: · Worklist management (WLM): allows the mobile view station to
receive scheduled patient data from
a WLM server on the hospital/departmental network. · Modality Performed
Procedure Step (MPPS): provides examination progress, dose report and status
information that can be used for reporting purposes. · Storage commit:
provides confirmation that images have been safely archived after exporting to
a
network storage device. · IHE profiles: compliant with IHE-SWF (Scheduled
Workflow profile).
4.3.13 Vascular Extension
If the vascular extension is installed, the vascular extension label is
present on the C-arm stand console.
Figure 31 Vascular extension label on the C-arm stand console
The vascular extension offers the optimal support for vascular cases, by
providing an extensive range of vascular imaging tools: · Subtraction mode
displays digitally subtracted images, for clear visualization of contrast
media. · Live Trace-mode (peak opacification) shows the maximum opacification
of the vessels. · View Trace (peak opacification) shows the maximum
opacification of the vessels in a trace image in
post processing. · Roadmap functionality supports catheter guidance. · Remask
to reselect the best image in a run as a mask image for contrast runs. · Smart
Mask reduces the X-ray dose and contrast medium usage by reusing previously
acquired
mask images for roadmapping. · Landmarking provides a non-subtracted
background image for anatomical reference. The visibility
of the background can be adjusted to meet user preferences. · Pixel shift
compensates for movement artifacts. · Subtraction on/off simplifies the
orientation for subtracted images during roadmap procedures
(controlled by remote control or the user interface on the mobile view
station). · CO2 subtraction mode.
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· CO2 trace mode (live trace white). · CO2 roadmap with Smart Mask (reuse of
previously acquired image).
4.3.14 Pain Extension
The pain examination consists of fluoroscopy, single shot, and digital
subtract functionality to enable clear visualization of contrast injections.
The subtract functionality also makes it possible to image the exact
vasculature in delicate regions of the spine to potentially reduce accidental
injection in the vessels.
4.3.15 Cardiac Extension
If the cardiac extension is installed, the cardiac extension label is present
on the C-arm stand console.
Figure 32 Cardiac extension label on the C-arm stand console
This extension provides the optimal support to perform cardiac procedures like
cardiac pacemaker placements. The optimized high pulse rate of maximal 30
frames per second enables sharp imaging of fast moving anatomy in the field of
interest.
4.3.16 Multi-Modality Viewer
You can import previously acquired images and pre-operative images from a
DICOM source, connected portable media or a DICOM network device using the
Multi-Modality Viewer . These images, originate from different modalities and
supports formats like XA, SC, CT, Ultrasound and MR images You can select
imported images for viewing with following viewing functionality: · Single
image view (All types of images) · MIP (CT/MR images) · MPR (CT/MR images) ·
Run loop (XA images) This Multi-Modality Viewer is available on the reference
monitor. User can delete imported data manually. For more information, see
Importing External Data (page 96).
4.3.17 External Video
You can view external video on the reference monitor using the optional
external video viewing function. If your system has the optional external
video viewing function, additional connectors are available on the mobile view
station connector panel, and an additional selection are available in the
system setup dialog box.
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For more information, see the following sections: · System Setup (page 40) ·
Mobile View Station Connector Panel (page 57) · Viewing External Video (page
181)
4.3.18 Outline Tool
The optional outline tool can be used to draw markings on an image where it
may be useful during a procedure, for example, during vascular surgery to mark
vessel branches and stent positioning on live fluoroscopy images. For more
information about outline tool, see Outline Tool (page 179)
4.3.19 Pediatric
This option provides dedicated pediatric exam settings for pediatric patients.
4.3.20 Utilization Information
Enables the system utilization data export when required by user.
4.3.21 Digital Navigation Link
Navigation devices are supported for frame rate greater than 15pps, continuous
fluro or single shot. Digital navigation link option will transfer the LIH
image to the connected navigation devices.
4.3.22 4kW
This option enables higher power examination modes.
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Safety
5 Operation
This section describes the procedures required to operate the system.
5.1 Safety
It is mandatory for the operator to be familiar with the safety procedures as
described in Safety (page 16). WARNING Do not use the system for any
application until you have read and understood and know all the safety
information, safety procedures and emergency procedures contained in these
Instructions for Use. Operation of the system without proper awareness of how
to use it safely could lead to fatal or other serious personal injury. It
could also lead to clinical misdiagnosis/mistreatment. WARNING Do not use the
system for any application until you are sure that the user routine checks
program has been satisfactorily completed, and that the planned maintenance
program is up-to-date. WARNING If any part of the equipment or system is known
(or suspected) to be defective or wrongly-adjusted, do not use the system.
Contact technical support to arrange a repair. Operation of the equipment or
system with defective or wrongly-adjusted components could expose the operator
or the patient to radiation or other safety hazards. This could lead to fatal
or other serious personal injury, or to clinical misdiagnosis/mistreatment.
WARNING Do not modify the equipment without authorization of the manufacturer.
Only authorized Philips representative can modify the equipment if required by
conducting appropriate inspection and testing to ensure continued safe use of
the equipment.
For information about the user routine checks program and the planned
maintenance program see Maintenance (page 190). WARNING Do not operate the
system with patients unless you have a good understanding of its capabilities
and functions. Using this equipment without such an understanding may
compromise its effectiveness and/or reduce the safety of the patient, user and
others.
It is important to read this manual before using the system.
5.2 Transportation
WARNING Limit the direction of transport across ramps (do not cross a ramp
sideways). WARNING Do not park on ramps with an angle greater than 5 degrees.
WARNING The effectiveness of the brakes strongly depends on the surface
characteristics of the floor or ramp.
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5.2.1 Putting the C-arm in the Transport Position
You should position the C-arm stand in the following positions for
transportation: · Putting C-arm in the Transport position for regular and Up
the ramp movements: Set Longitudinal
travel to 0 cm for moving the stand. · Putting C-arm in the Transport position
for down the ramp movement: Set Longitudinal travel to 20
cm for moving the stand down the ramp. · Swivel movement 0 degrees position ·
Height movement 8 cm position · Rotation in 0 degrees position · Angulation in
0 degrees position
Figure 33 Transport position – up ramp
Figure 34 Transport position – down ramp
For further details, see C-arm Brakes and Movements (page 74) NOTE Lock all
the C-arm movements, whilst the system is in transport position.
5.2.2 Moving the C-arm Stand
1 Release the brake. The C-arm stand has two brake pedals: one on each side.
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Figure 35 Releasing the C-arm stand brake
When releasing the brake, place your whole foot on the pedal and gently tilt
the pedal towards the release position.
2 Control movement of the stand using the push bar and steering handles.
With the steering handles in either the left or right position, the C-arm stand can be moved sideways.
NOTE
Steering handles are only intended for positioning the C-arm at the acquisition location. Steering handles should not be used during transportation except where difficult or tight corners are encountered.
Both steering handles are coupled and control the rear wheels. They have three pre-defined (`click’) positions, straight-ahead, left and right. In addition, all wheeled positions in between the predefined positions can be used to move the stand in the corresponding direction. The front wheels are free swiveling.
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1
1 2
3
Figure 36 Moving the C-arm stand
Legend 1 2 3
Steering handle Push bar Brake pedal
3 When the stand is in the required location, position it exactly using the steering handles.
4 Apply the brake by pressing the pedal towards the locked position indicated by the symbol.
5.2.3 Moving the Mobile View Station
The mobile view station can be moved using the push bar. A brake can be
applied or two wheels can be locked for transport over long distances. The
mobile view station has dual pedals at each rear wheel.
Using the Dual Pedals The mobile view station has dual pedals (red and gray)
that can be used to lock and brake the rear wheels.
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Figure 37 Dual pedals for locking and braking the mobile view station. 1 Lock the wheels in parallel for transport by pressing both gray pedals only.
1
2
Figure 38 Wheels unlocked, locked for transportation with brakes not applied,
and braked. 2 Apply the brake by pressing the red pedals of both wheels down.
3 Release the brake without releasing the wheel lock by pressing the upper
part of the red pedal only
on both wheels. 4 Release the wheels after transport by pushing the upper part
of the gray pedals.
5.2.4
Putting the Monitors in the Transport Position
WARNING Ensure that the monitors are placed in the transport position before
transporting the mobile view station.
During transportation of the mobile view station, the monitors should be
closed and locked, using the two locking bolts at the back of the monitors. 1
Lower the monitors to the lowest position. 2 Fold the monitors together. 3
Stow the cables using the cable brackets at the side of the mobile view
station.
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Figure 39 Putting the monitors in the transport position
4 To lock the monitors, pull the locking bolt out, turn it 90 degrees, and
then let it slide back into the locked position.
Figure 40 Monitors: locking bolts for transport 5 To unlock the monitors, pull
the locking bolt out, turn it 90 degrees, and then let it slide back into
the unlocked position.
5.3 Positioning
NOTE Do not position the system such that it makes it difficult in a case of
emergency to remove the mains power plug from the socket outlet.
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C-arm It is recommended to fit sterile covers before using the system with a
patient. For details, see Fitting the Spring Bow (page 182).
Mobile View Station WARNING Do not position the mobile view station with the
rear (open) side next to the patient. The rear of the mobile view station has
a fan which could adversely affect the sterile air flow. The mobile view
station should always be positioned so that the front (closed) side is closest
to the patient (see the figure below).
Figure 41 Mobile view station: Front side (left) and rear side (right)
5.3.1 C-arm Repositioning
During examinations, the surgeon may request that the C-arm is repositioned.
The ClearGuide function supports communication between the surgeon and the
operator in such cases. For more information about ClearGuide and about using
ClearGuide, see ClearGuide (page 128). After seeing an X-ray image, the
surgeon may ask the operator to reposition the C-arm. For example, the surgeon
may ask the operator to reposition the C-arm so that the 6 marker on the
detector is closer to the middle of the patient.
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C-arm Brakes and Movements
Figure 42 ClearGuide – C-arm in initial position (left) and repositioned
(right) The operator would reposition the C-arm to move the detector to the
new position.
5.4 C-arm Brakes and Movements
Figure 43 C-arm Brakes and Movements
Brake / Movement 1 Rotation brake / movement 2 Angulation brake / movement 3
Longitudinal brake / movement 4 Swivel (wig-wag) brake / movement
handles
Color code Orange Blue Pink Black
Type Electronic Electronic Electronic Manual
The brake for each C-arm movement is color-coded for identification.
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NOTE Although the movements are balanced it is strongly recommended to apply
the C-arm brakes always.
5.4.1 Electronic Brake Switches
You can use Electronic Brake switches to engage or disengage movement of the
C-arm in the operating room with ease. The C-arm movement can be performed
along three axis namely Rotation, Angulation and Longitudinal.
1 3
2
Figure 44 C-arm 3-Axis movement
Legend 1 2 3
Rotation Angulation Longitudinal
By default, the brakes are in locked state. You can unlock the brakes either
by pressing the switches on the stand or by pressing the switches on the
detector side. The unlocking period for the brakes is configured by Philips
Service Engineer.
NOTE Based on the system configuration, the Electronic Brake switches could be
set to be unlocked for a duration between 1 min to 5 min.
NOTE Maximum limit to release/lock brakes of 25 cycles per minute is allowed.
Once this limit is reached, the brakes will be in locked state for next 1
minute/30 seconds of time.
Detector Side – Electronic Brake Switches
Front panel of the detector comprises a handle with two identical switches on
both sides of the detector.
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1
1
2
2
Figure 45 Electronic Brake switches on detector
You can perform Rotation and Angulation movement with Switch 1 and Longitudinal/Horizontal movement with Switch 2. The individual switches are color coded for identification
Legend
1
2
Switch
Switch 1 Switch 2
Movements
Rotation and Angulation Longitudinal / Horizontal
Press the switch to perform the desired movement, and release the switch to lock the C-arm movement in desired position. The detector side switches are always illuminated such that user can easily locate the switches even with transparent drapes on. The operator side switches will be illuminated only when the brakes are released to indicate the status of the brakes.
NOTE
If there is simultaneous operation of Electronic Brake switches from the detector side as well as from the operator side, then the detector side action will get higher priority compared to the operator side.
NOTE Use transparent drapes on FD to view surgeon Electronic Brake switches on
FD. Stand Side – Electronic Brake Switches
Stand comprises of three switches for individual axis control that is
Rotation, Angulation and Longitudinal.
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Figure 46 Electronic brake switches on stand
The switches are present on the either side of the stand. Press the switch to
perform the desired movement, and release the switch to lock the switch and
keep the desired position.
5.4.2 Rotation
Switch on the C-arm stand. Press the orange switch (Electronic switch) on the
stand or detector to perform rotational movement. Release the switch to lock
the C-arm movement in desired position. The degree of rotation is indicated on
the scale and on the stand side graphical user interface. The range of
rotation is +200 degrees to 200 degrees.
Figure 47 Rotation and degrees of rotation markers
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Legend 1
Rotation – Movement measurement markers
5.4.3 Angulation
Press the blue switch (Electronic switch) on the stand or detector to perform
angulation movement, . Release the switch to lock the C-arm movement in
desired position.
The degree of angulation is shown on the scale and on stand side graphical
user interface. The angulation range is +90 degrees to -66 degrees.
Figure 48 Angulation – Degree of rotation
Legend
2
Angulation – Movement measurement markers
5.4.4 Longitudinal Movement
Press the pink switch (Electronic switch) on the stand or detector to perform
the longitudinal/horizontal movement. Release the switch to lock the C-arm
movement in desired position.
The longitudinal movement is shown on the scale and on stand side graphical
user interface. The longitudinal movement range is 20 cm.
Figure 49 Longitudinal – movement measurement
Legend 3
Longitudinal – Movement measurement markers
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5.4.5 Swivel (Wig-Wag) Movement
To release the swivel movement brake (black handles), move the two handles
upwards. To re- apply the brake, return the handles to the locked position.
The swivel range is -10 degrees to +10 degrees.
Figure 50 Swivel (wig-wag) brake handle (4), one handle on each side
Legend 4
Swivel (wig-wag) – Movement measurement markers
The swivel (wig-wag) brakes have symbols to indicate their movements and
status. When the brake is released, the handle points to the unlocked’ symbol. When the brake is applied, the handle points to thelocked’ symbol.
Brake unlocked
Brake locked
5.4.6 Height Movement
The adjustment of the height is controlled by switches on both sides of the
C-arm stand.
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Figure 51 Height movement buttons
1 Switch on the C-arm stand. 2 Press the Up switch to move the C-arm upwards.
The upwards movement will continue until the
switch is released or when the up limit is reached.
The C-arm stand has a height movement range of 49 cm. 3 Press the Down switch
to move the C-arm downwards. The downwards movement will continue
until the switch is released or when the transport position is reached.
4 At the transport position, the movement stops and the indicator light beside
the switches is on. 5 To continue the downwards movement into the extended
range, press the Down switch again. An
audible signal is given at the beginning of this movement and the indicator
light remains lit. NOTE If any irregularities occur in either direction of
height movement during use, switch off
the system as described in Emergency Power Off (page 17) CAUTION When using
the system in the extended range, extra care must be taken to avoid collisions
with the floor or other objects. CAUTION When the light indicator blinks, it
indicates central circuit failure and the height movement is disabled.
5.4.7 Electronic Brake Switches Status indicator
You can view Electronic Brake switches status indication on MVS when you
perform any C-arm movement. The Electronic Brake switches status icons are
visible only when you connect the stand to
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the MVS and MVS is powered on. Each color represents activation/deactivation
of the C-arm movement.
· Rotational movement – Orange color · Angulation movement – Blue color ·
Longitudinal movement – Pink color
Indication
Description
Grey outline: Electronic Brake switches status is disabled. There is no Electronic Brake switches communication from the stand interface, while the MVS is connected to the stand and powered on.
Colored outline: The respective movement color outline is enabled on the MVS once there is Electronic Brake switches communication from the stand interface or from the surgeon control handle on the detector; that is Electronic Brake switches are in locked state.
Filled color: The respective movement Electronic Brake switches will be filled and remain active that is they are in released state.
5.5 System On/Off
This section describes connecting the system, using the system lock and
earthing.
5.5.1
Connecting the System
WARNING Optional equipment is only to be used if it is certified for the
applicable standards and fully compatible with the system in use. The use of
accessory equipment not complying with the equivalent safety requirements of
the system may lead to a reduced level of safety in the resulting system. Any
patient environment equipment connected to the system must comply with
ANSI/AAMI ES60601-1 and IEC 60601-1 requirements. Equipment outside the
patient environment may only be connected to the system if it complies with
the relevant UL/ANSI/AAMI and EN/IEC standards.
WARNING To avoid risk of electric shock, this equipment must only be connected
to supply mains with protective earth.
CAUTION Make sure that the socket outlet is provided with proper ground
connection accepting grounding cord plugs. The resistance in the socket outlet
must conform to the mains supply specifications as described in these
Instructions for Use.
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Figure 52 C-arm stand connector panel
Legend
1
Foot switch connector
3
System lock
2
Touch Screen Module (TSM) port
4
Mobile view station connector
When the C-arm stand and the mobile view station are in the desired position,
make the following electrical connections.
1 Connect the mobile view station cable to the C-arm stand and turn the
fastener clockwise until it clicks into place.
Figure 53 C-arm stand connector panel with cable connections 2 Connect the mains power cable of the mobile view station to a suitable mains power outlet socket. 3 If applicable, connect the foot switch to the C-arm stand connector panel. 4 If applicable, connect the TSM to the C-am stand connector panel.
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5.5.2
Switching the System On
1 Press the System on button on the C-arm stand or press the System on button
on the mobile view station.
2 If password protection is enabled, the log on screen is displayed. The password protection function protects patient data from unauthorized access.
To log on, enter your user name and password, and click Log On
NOTE
The system performs a system initialization and a self-test. A startup screen is displayed on the examination monitor of the mobile view station and on the C-arm stand touch screen.
3 To start an emergency examination without logging on, click Emergency Use.
The system starts, but you cannot perform the following functions: · Review existing examinations · Start scheduled examinations · Export, save, and print data
4 If password protection is not enabled, the system will log in without authorization.
CAUTION To prevent malfunction, do not touch any controls during the startup
process (except the height movement buttons).
The system is ready for use when: · The examination monitor displays the
administration screen · The C-arm stand touch screen displays status and
settings · No error messages are given
For more information about starting a procedure, see Selecting a Patient for
Acquisition (page 100).
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Figure 54 Mobile view station administration screen
Figure 55 C-arm stand touch screen after start-up
NOTE
To avoid casual or deliberate viewing of patient data by unauthorized persons, do not leave the system unattended while it is switched on. If the system is not required, you should switch it off.
If images are queued for transfer from a previous session, a panel is displayed on the examination monitor to remind you that images are queued.
If disk space is becoming low, the reminder panel also displays an information message, reminding you to delete examinations that are no longer needed, to avoid automatic overwriting of older examinations.
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5 Click the OK button to close the reminder panel.
NOTE If the password protection function is enabled, the reminder panel is not
displayed if a valid user name password is not entered.
WARNING When the system is powered up for use with system lock key in position
1, the system is in X-ray enabled state. It is recommended to keep the system
in X-ray disabled state at all times, except when a procedure is in progress;
to prevent the possibility of RADIATION being emitted through the accidental
actuation of a foot switch/hand switch.
Tips Stand alone mode mobile view station
System lock Height movement
The mobile view station can be used in stand alone mode (without the C-arm
stand connected) for viewing and post-processing. The system is designed so
that no patient mix up is possible. One of the prevention measures is that
each time the mobile view station is switched on, a new Patient file is
created. However there are times during an operation when the C-arm stand
needs to be repositioned or temporarily removed, and then new images should be
added to the same patient file. To allow for this situation the system is
designed so that while the mobile view station remains switched on, the C-arm
stand can be switched off and disconnected. It can then be reconnected and
switched on. In this situation the new images are added to the open Patient
file.
To perform X-ray, the system lock must be enabled (with the key in the I
position).
Height movement can be used a few seconds after pressing one of the System on
buttons.
5.5.3 Switching Users
You can switch users without logging the original user off. You may want to
switch users temporarily to perform specific tasks. For example, specific
parts of the clinical procedure, or system tasks that require an
administrator’s account. Switching users maintains the audit trail for the
procedure by recording the correct responsible user. 1 Open the administration
screen by pressing the Administration button.
2 Click System and select Switch Users. A dialog box is displayed requesting
the new user name and password.
3 Enter the User name and Password for the user you are switching to. 4 To
close the dialog box without switching users, click Cancel. 5 To switch users,
click Switch.
The system switches to the new user and continues.
5.5.4 Changing Your Password
You can change your password once you are logged in. If your system has
password complexity enabled at installation, your password must have: · A
minimum number of characters (consult with your hospital administrator) · At
least one uppercase character
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Operation
System On/Off
· At least one number character · At least one symbol character 1 Open the
administration screen by pressing the Administration button.
2 Click System and select Change Password. A dialog box is displayed
requesting your existing and new passwords.
3 Enter your Current password. 4 Enter your New password. 5 Re-enter your new
password in the Confirm new password box. 6 To close the dialog box without
changing your password, click Cancel. 7 To change your password, click Change.
5.5.5 Switching the System Off
1 Switch off the complete system by pressing the System off button on the
mobile view station. On the C-arm stand, the following functions are switched
off immediately: · Radiation · Motorized height movement Remaining functions
on the C-arm stand and mobile view station are switched off automatically in a
controlled way to avoid data loss. The controlled shut down process may take
several seconds to complete. When the shut down process is complete, wait 5
seconds before switching the system on again.
2 Only unplug the system when the display indicates that the shutdown
procedure is complete. NOTE Pressing the System off button for more than 3
seconds immediately removes power to the entire system. NOTE Pressing the
C-arm stand off button on the C-arm stand switches off only the C-arm stand.
5.5.6 Emergency Power Off
In case of emergency, switch the system off. 1 To switch off only the C-arm
stand in an emergency, press the Emergency off button on the C-arm
stand console. X-ray generation and height movements are no longer available.
2 To switch off the system, press System off on the mobile view station.
3 Remove the mobile view station mains power plug from the socket outlet.
WARNING When the Emergency off button is pressed, mains power is still applied
to some circuits in the system until the mobile view station mains power plug
is removed from the socket outlet.
5.5.7 Mains Failure
If mains power fails during an acquisition, all images from the current
acquisition run are lost and the dose report for the lost acquisition run is
not updated.
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Operation
Monitors
The network connection is also lost and transfer jobs are aborted. Transfer
jobs aborted during the selection for transfer queuing are lost and need to be
selected and queued again.
When main power is restored, you should switch the system on again. The time
for the system to restart for imaging is approximately 3 minutes. The system
starts with the default settings selected and a new patient.
Reference images and subtraction masks should be remade for the current
patient.
Transfer jobs aborted while being transferred to the DICOM network, or when
queued, are not lost and are automatically transferred again. You can resume
or check aborted transfer jobs in the transfer queue by opening the job
viewer. For more information, see Viewing Transfer Jobs in the Job Viewer
(page 167).
5.6 Monitors
The mobile view station is equipped with two LCD monitors. The left monitor is
the examination monitor and the right monitor is the reference monitor. The
examination monitor displays live images and last image hold (LIH). You also
use the examin
References
- Adobe - Download Adobe Acrobat Reader
- socialnet - Das Netz für die Sozialwirtschaft
- COCIR: Saving Energy
- dtsc.ca.gov/hazardouswaste/perchlorate
- Radiation-Emitting Products and Procedures | FDA
- Philips Healthcare | Sustainability
- Product Security | Philips
- Pediatric Radiology & Imaging | Radiation Safety – Image Gently
- Recycling | Philips
- Healthcare | Ecolab
- P65Warnings.ca.gov
- Society for Pediatric Radiology | SPR
- Environmental, Social and Governance (ESG) | Philips
- Chemicals management | Philips
- Resource center | Philips
- Product Security | Philips
- Symbol Library | Philips
- Support Library | Philips
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