Ziehm Imaging C Arm Quantum User Manual
Ziehm Imaging C Arm Quantum User Manual
Ziehm Imaging C Arm Quantum User Manual
USER’S MANUAL
Table of Contents
TABLE OF CONTENTS
ABOUT THIS MANUAL ....................................................................................................................................... 11
1.0 SAFETY & RESPONSIBILITIES ..................................................................................................................... 13
1.1 INTENDED USE ............................................................................................................................................... 13
1.2 OPERATION (U.S.A.) ...................................................................................................................................... 13
1.3 AUTHORIZED PERSONNEL ............................................................................................................................. 13
1.4 EQUIPMENT OWNER RESPONSIBILITIES ........................................................................................................ 14
1.5 HOSPITAL ADMINISTRATION ......................................................................................................................... 14
1.6 MANUFACTURER ........................................................................................................................................... 14
1.7 EXCLUSION OF LIABILITY ............................................................................................................................... 14
1.8 USA REGULATORY RESPONSIBILITIES ............................................................................................................ 15
1.8.1 SERVICE ENGINEERS/TECHNICIAN ............................................................................................................ 15
1.8.2 SYSTEM USERS .......................................................................................................................................... 15
1.9 CDRH REPORT ................................................................................................................................................ 15
1.10 PROBLEMS ................................................................................................................................................ 15
1.11 REGULATORY /NOTIFIED BODY ................................................................................................................ 15
1.12 RECORD KEEPING USA .............................................................................................................................. 15
2.0 SYSTEM OVERVIEW SECTION .................................................................................................................... 17
2.1 FIELDS OF APPLICATION ................................................................................................................................ 17
2.2 FEATURES ...................................................................................................................................................... 17
2.2.1 MOBILITY .................................................................................................................................................. 17
2.2.2 ORGAN PROGRAMS .................................................................................................................................. 17
2.2.3 RADIATION REDUCTION ........................................................................................................................... 17
2.2.4 IMAGE QUALITY ........................................................................................................................................ 17
2.2.5 IMAGE ADJUSTMENT ................................................................................................................................ 17
2.2.6 IMAGE MANAGEMENT ............................................................................................................................. 18
2.2.7 DOCUMENTATION AND OUTPUT ............................................................................................................. 18
2.2.8 NETWORKABILITY ..................................................................................................................................... 18
2.3 OPTIONS ........................................................................................................................................................ 18
2.4 OPTIONAL ACCESSORIES ............................................................................................................................... 19
2.5 PARTS OF THE SYSTEM .................................................................................................................................. 20
2.5.1 C‐ARM STAND ........................................................................................................................................... 20
2.5.2 TWIN FLAT PANEL MONITORS .................................................................................................................. 20
2.5.3 MONITOR POSITION ................................................................................................................................. 21
2.5.4 DUAL FLAT PANEL LCD MONITORS ........................................................................................................... 23
2.5.5 CHANGING THE MONITOR SETTINGS ....................................................................................................... 24
2.5.6 ZIEHM QUANTUM FP MONITORS ADJUSTMENTS .................................................................................... 24
2.5.6.1. MONITOR SETTINGS ............................................................................................................................ 24
2.5.6.2. INTEGRATED BUTTON PANEL .............................................................................................................. 24
2.5.6.3. SETTING THE BRIGHTNESS, CONTRAST AND BACKLIGHT BRIGHTNESS ............................................... 24
2.5.6.4. SETTING THE MENU LANGUAGE .......................................................................................................... 26
2.5.6.5. RESTORING THE FACTORY SETTINGS ................................................................................................... 27
2.5.7 BNC SOCKET VIDEO OUTPUT .................................................................................................................... 28
3.0 SAFETY INSTRUCTIONS ............................................................................................................................. 29
3.1 GENERAL SAFETY INSTRUCTIONS .................................................................................................................. 29
3.1.1 OPERATION ............................................................................................................................................... 29
3.1.2 OPERATION (U.S.A.) ASSEMBLY AND SERVICE ......................................................................................... 29
3.1.3 WARRANTY VOIDED ................................................................................................................................. 29
3.2 X‐RAY AND ELECTRICAL SAFETY .................................................................................................................... 29
For several system options, separate operating instructions are available. They Separate
are supplied with the system, provided that the system configuration includes operating
the respective option. You will find a corresponding reference in the relevant instructions
sections of the manual.
WARNING
This is the highest level of risk. Personal injury or damage to property may
occur if the operator does not observe the instructions provided here.
CAUTION
This means that a situation exists which may require a decision or action on
the part of the user for optimum equipment performance or to avoid a minor
hazard.
NOTE
Notes are informative. Additional useful information and hints are provided
for the operator here.
1.6 MANUFACTURER
The manufacturer is responsible for the safety, reliability and efficiency of the equipment only
when:
• Installation, alterations or repairs are carried out by persons authorized by the manufacturer.
• The electrical installation in the room in which the ZIEHM QUANTUM is used
corresponds to the power requirements listed in Appendix A.
• The equipment is used in accordance with this manual and the operator follows said manual.
1.10 PROBLEMS
If System Users have an equipment-related problem, they must immediately stop using the
system and notify a Service Engineer. The system must not be operated until repairs have been
made and the proper functioning of the system is verified.
2.2 FEATURES
2.2.1 MOBILITY
With its compact design and combined steering & braking system, the ZIEHM QUANTUM
offers the operator unrestricted mobility in positioning at the operating table, even if space is
scarce.
The easy adjustability and accurate counterbalancing of the ample C-Arm profile and stand
makes it possible to access even the most difficult positions.
2.2.8 NETWORKABILITY
The optional DICOM 3.0 interface (Quantum FlexNet) enables integration into any network
supporting DICOM 3.0, e.g. PACS. Thanks to “Primary Capture” support, the original
fluoroscopic images can be archived without changes to the image that may have been applied to
them later. The following DICOM Classes are available:
- Storage
- Work list
- Print
WARNING
Do not touch the USB or DICOM ports and the patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
Accessory equipment connected to the analog and digital interfaces must be
certified to the respective IEC standards (i.e. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment.) Furthermore, all
configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the system
complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical
services department of your local representative.
2.3 OPTIONS
This manual describes a system with maximum configuration. The system configuration chosen
by you may not contain all options and functions described here.
The following options can be integrated into the system upon request:
- The DICOM 3.0 interface ZIEHM QUANTUM FlexNet (Primary Capture)
Depending on the system configuration chosen, the following functions, features and
DICOM Classes are supported:
- DICOM
- Print Class
- Storage Class including multi-frame capability
- Media Class (images for DSA and Cine sequences)
- Worklist Class
- Laser targeting device on the generator and/or image intensifier
- USB DVD writer
- CINE with 5/10/15 frames per second (15 frames per second only with DSA option)
- DSA with final Max Opacification (MSA) image on reference monitor.
- Additional image storage: 1000/5,000/10,000/20,000 images (20,000 images only with
DSA option)
- USB Port using certified USB 2.0 USB Memory storage device
- Image export of AVI image format for motion studies (Cine)
- JEG, BMP and DIOCM 3.0 media image formats. (Available image formats vary
depending on system configurations)
WARNING
Do not touch the USB or DICOM ports and the patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
The Optional USB port does not support externally powered USB devices.
WARNING
Accessory equipment connected to the analog and digital interfaces must be certified
to the respective IEC standards (i.e. IEC 60950 for data processing equipment and
IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply
with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the system
complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical
services department of your local representative.
ON OFF
On the rear side of each flat-screen monitor, there is an ON/OFF
switch.
NOTE
Newer models may not have the Power Switch.
CAUTION
Always set the ON/OFF switches on the flat-screen monitors to ON in order to
ensure that the monitors are switched on automatically during power-up of the
system. If power is turned off after initial turn on of the system, operator must
switch off both monitors and then back on again at the same time, to make sure
both monitors start at the same time.
CAUTION
The standard mounting of the Flat-screen Monitors are on a pivot and can be
swiveled approximately 180 degrees; please use caution when moving the monitors
as collision with other devices may occur as well as collision with the Desk View
Touch Screen.
CAUTION
The Optional Quick Release mounting of the Flat-screen Monitors are on a pivot
and can be swiveled approximately 320 degrees; please use caution when moving
the monitors as collision with other devices may occur as well as collision with the
Desk View Touch Screen.
NOTE:
To avoid confusion, the neutral terms ‘live monitor’ and reference monitor’ are used
throughout this manual, regardless of your custom setting.
Contrast
NOTE
Lowering the backlight level will increase the backlight lifetime.
• Select the Setup menu with the help of the Plus or Minus button.
• Move to the Language menu item with the help of the Scroll
button.
• Press the Plus button until the desired language is displayed. All
menus and menu items are displayed immediately in the chosen
language.
• Press the Menu button. The menu selection window disappears
• Select the Defaults menu with the help of the Plus or Minus button.
WARNING
Any supplementary, third-party devices, and or components used in combination
with the ZIEHM QUANTUM must comply with the safety requirements according
to IEC 60601-1 and/or IEC 60601-1-1 or furnish proof of an equivalent degree of
safety. Combining the ZIEHM QUANTUM with equipment which does not
comply with IEC 60601-1 and/or IEC 60601-1-1, will lower the safety
classification, compromising the safety of the whole system, which may result in
death or serious injury!
Non-compliance with IEC 60601-1 and or IEC 60601-1-1 may also result with
invalidation of warranty!
WARNING
You must be familiar with the contents of this user manual in order to be able
to operate the system as intended. Study this user manual thoroughly before
operating the system.
It is important to observe all directions, safety instructions, and warnings!
3.1.1 OPERATION
Only properly trained personnel are allowed to operate the system.
The system may only be operated by properly trained personnel under the direction of a
physician.
3.1.2 OPERATION (U.S.A.) ASSEMBLY AND SERVICE
Only authorized personnel are allowed to assemble the system and to provide technical service.
The necessary qualifications can only be obtained by attending a training course provided by the
manufacturer.
3.1.3 WARRANTY VOIDED
Warranty will not be given for equipment that has been repaired by non-authorized persons, or
that has been damaged through misuse.
WARNING
Always observe the relevant regulations of the country of the installation for
putting the system into service, training of personnel and maintenance.
WARNING
Never use the system if you suspect any electrical or radiation generating
components to be defective!
WARNING
Never pull at the Power Cable of the Mobile Stand in order to move the Mobile
Stand to another position; otherwise severe equipment damage may result.
3.2.2 HAZARDS
3.2.2.1. X-RAY TUBE HOUSING
Tube housings have the following hazards:
1. High voltage. Normal operating voltages can be deadly.
2. Hot oil. Tube housings contain die electric oil which can reach high
temperatures. If the tube housing ruptures due to overload, the oil that leaks out
can cause serious burns.
3. X-ray radiation. X-ray tubes produce x-radiation that is dangerous and
potentially fatal.
3.2.2.2. X-RAY TUBE
The x-ray tube has a stationary anode, with dual focus. Here are some specific
qualities of the x-ray tube:
1. Focal spot size, for fluoroscopy 0.6 mm2
2. Radiography 1.5 mm2
3. Inherent filtration equivalent 110kV > 2.5 mm AL
3.2.2.3. RADIATION WARNING
This equipment produces x-rays, which are dangerous to operators and others in the vicinity, if
relevant safety procedures are not strictly adhered to. Useful and scattered beams can cause
serious or fatal injuries to any persons in the surrounding area if the equipment is used by
unskilled operators. Take appropriate precautions to avoid exposure to the radiation beam, and
radiation leakage from the generator housing.
Only authorized personnel should operate, or direct the operation of, this equipment. Persons
become authorized, in part, by becoming completely familiar with, and adhering to, 21 CFR,
Subchapter J - Radiological Health; and National Council on Radiation Protection (NCRP)
document 33 - Medical X-ray and Gamma-Ray Protection for Energies up to 10 MEV:
Equipment Design and Use.
Persons responsible for planning the installation of x-ray equipment must be completely familiar
with, and adhere to, NCRP 49 - Structural Shielding Design and Evaluation for Medical Use of
X-rays and Gamma-rays of Energies up To 10 MEV.
Take care to keep patient radiation exposure to a minimum and to use the lowest-possible dose
rates. Maintain the highest possible focus-skin distance. The stipulated minimum focus-skin
distance is 20 cm and is ensured by the design of the generator, with the required special skin
cone. Additional objects in the path of the x-ray (e.g. operating table) will lead to an increase in
radiation dose.
3.2.2.4. PROTECTION-OF STAFF
Staff members who stay within the radiation controlled area must wear X-Ray-protective
clothing.
The radiation controlled area depends upon the size of the Image Intensifier installed and has the
following radius:
−23 cm Image Intensifier. Requires 4 meter control area.
• Image power supply control assemblies (220-230 VAC and 120 VAC)
• Generator inverter control (300 VDC, at 20 KHz)
3.3.4 PERFORMING INTERNAL SERVICE
Only Trained Service Engineers are to perform any internal service, the Service Engineers must
be trained in the Emergency Power Removal procedure. Service Engineers must fully understand
equipment circuits and voltages.
Safety rules that must be followed:
• Before removing equipment covers, disconnect the power cord from the power source.
• Never assume that a capacitor is discharged. Use a ground shorting device when working
on circuits with capacitors, even when the equipment is disconnected from a power source.
• Make sure that equipment connections are made as described in the Installation section of
the Installation and service manual.
3.4 GENERAL SAFETY
Do not, under any circumstances, remove, by-pass, jumper, or disable safety interlocks.
Before cleaning the equipment, ALWAYS unplug the AC power cable from the wall. If liquid
drips into system equipment, it will cause electrical short circuits that may result in electrical
shock or fire hazard. Therefore, NEVER allow beverage or food containers to be placed on
system equipment.
Never operate the system in a location where conductive fluids, such as water, or saline solution,
may come into contact with any part of the equipment, unless the equipment is covered in
protective waterproof draping.
WARNING
The system may only be operated by personnel who have undergone
radiological training.
WARNING
The system may only be operated by properly trained personnel under the
direction of a physician.
WARNING
The relevant safety regulations of the country of installation should be
observed.
WARNING
Ambient temperature greater than 60 degrees centigrade may cause irreversible
damage to the Image Intensifier tube.
WARNING
In order to avoid unintentional radiation, the foot switch must be placed in the
foot switch support holder when the system is switched on, but is not in use.
WARNING
This x-ray unit may be dangerous to patient and operator unless safe exposure
factors, operating instructions and maintenance schedules are observed.
3.4.1 GETTERING
If the system is stored for more than 6 uninterrupted months, we recommend that you turn it on
for at least one hour before using it. Doing so will significantly prolong the useful life of the
image intensifier.
We also recommend that you keep a logbook of operating hours, gettering times, and
maintenance details.
3.4.2 BONDING
If the equipment is used in combination with other equipment for the examination of the heart or
brain, or their proximity, a potential bonding conductor is required for the safety of patients and
operators (IEC and VDE regulations).
You must ensure that the x-ray system meets the requirements of IEC 601 part 1 through a
program of regular maintenance and periodic inspection. You can find a schedule for periodic
inspection in the Technical Manual.
Mobile Stands, and its integrated components (such as monitor, touch screen, USB image storage
devices) are not AP-version. They may not be used in the presence of flammable gasses.
WARNING
Any Supplementary, third-party devices, and or components used in combination
with the ZIEHM QUANTUM must comply with the safety requirements
according to IEC 60601-1 and/or IEC 60601-1-1 or furnish proof of an equivalent
degree of safety. Combining the ZIEHM QUANTUM with equipment that does
not comply with IEC 60601-1 and/or IEC 60601-1-1, will lower the safety
classification, compromising the safety of the whole system, which may result in
death or serious injury!
Non-compliance with IEC 60601-1 and or IEC 60601-1-1 may also result with
invalidation of warranty!
WARNING
Make sure that no additional material (e.g. an operating table not suitable for X-
raying) is located in the beam path.
Additional material located in the beam path may result in a dose increase when
using a fluoroscopy mode with automatic exposure rate control.
WARNING
Do not touch the USB or DICOM ports and Patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
Accessory equipment connected to the analog and digital interfaces must be
certified to the respective IEC standards (i.e. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment.) Furthermore, all
configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the
system complies with the requirements of IEC 60601-1-1. If in doubt, consult the
technical services department of your local representative.
The laser targeting device is a Class 2 laser product according to IEC 60825-1:2001 and CLASS
II, in accordance with FDA 21 CFR, Subchapter J, Section 1040.10 - you must comply with all
operating precautions when operating the laser device.
The maximum output of continuous laser radiation, measured at the beam exit, is <1 mW. The
wavelength of the emitted radiation is 635 nm.
WARNING
LASER RADIATION – DO NOT LOOK INTO THE BEAM!
Please observe the provisions of IEC 60825-1:2001, Section 3 and 21CFR
1040.10-11. Guidelines for the User of the laser devices.
3.6.2 MAINTENANCE
The laser targeting device is maintenance-free. Any adjustment or repair which might become
necessary must be carried out be the manuafacturer or a person who has been authorized to do so
by the manuafacturer.
Figure 3.1: Laser Beam Aperture on the Image Intensifier (left) and on the Generator (right)
WARNING:
LASER RADIATION DO NOT LOOK INTO THE BEAM! LASER
CLASS II, IN ACCORDANCE WITH FDA 21 CFR, Subchapter J, Section
1040.10 - 11 and EN60825 - 1:1994.
You must comply with all operating safety precautions when operating the laser device. The
maximum output of continuous laser radiation, measured at the laser beam exit is <1 mW. The
wavelength of the emitted radiation is 635 nm. The laser device is maintenance-free. However,
if adjustment or repair work becomes necessary, it must be performed by the manufacturer or
other authorized persons.
17b
16
15
15 14
42
WARNING:
Do not operate the system until the equipment has reached a safe operating
temperature of +15°C to +35°C with no condensation present. Otherwise severe
equipment damage may result.
WARNING:
You must be familiar with the contents of this user manual in order to be able to
operate the system as intended. Study this user manual thoroughly before
operating the system.
It is important to observe all directions, safety instructions and warnings!
WARNING:
Only authorized personnel are allowed to unpack and assemble the system.
During assembly, the system may be handled only by trained personnel who have
studied the contents of Ch. 4, Unpacking and System Power On and Ch. 5,
Mechanical Handling.
4.1.5 UNPACKING
Unpacking of the x-ray system is to be carried out by authorized, qualified personnel.
1. To avoid damage to the equipment by condensation of moisture resulting from temperature
differences, make sure that all parts of the equipment have reached room temperature
before turning the equipment on.
2. Remove the outside of the shipping container and inspect for damage.
3. Lower the unloading ramp into position.
4. Remove the metal brackets that hold the C-Arm mobile stand to the pallet. Take care not to
scratch the mobile stand.
5. Remove the two straps that hold the monitors and take the monitors off the pallet.
6. Remove all of the brackets from the pallet.
7. Loosen the Wig-Wag knob and straighten the C-Arm. This will keep the C-Arm from
tipping over as it is removed from the pallet.
8. Lift the lever located in the center of the control panel (the hand brake) and carefully move
the mobile stand off the pallet and onto the floor.
NOTE
Make sure the quick release monitor locking pins are full seated after installation,
and shall be inspected to make they are fully seated before movement of the C-arm
for transport of use.
Bayonet
Step 1 Step 2
Firmly grasp the outside out of each monitor. Place monitor over bayonet mounting
Step 3 Step 4a
Wiggle monitor a little bit to seat the connector Now lock the monitor to the pivot arm assembly
Step 4b Step 4b
Turn Locking pin to align with slot Allow pin to drop into slot making sure of tight fit.
WARNING:
Do not use a 3-prong to 2-prong adapter, unless properly installed by a qualified and
licensed electrician. Failure to comply may result in serious or fatal injuries to the
System and or User and other persons in the surrounding area.
Ensure that the AC line voltage is compatible with the power requirements of the system. Line
voltage must be set for a line voltage of 120 VAC + 10% and Line resistance is < 0.6 Ohms.
Verify power input to the Mobile stand Module 1 and adjust the AC wall Line voltage
accordingly to correct the wall outlet drop in power. (For example, if the wall outlet idles at 120
VAC and drops to i.e. 108 VAC when the x-ray system produces fluoroscopy at 90 to 110 kV,
then the line voltage must be adjusted at the wall for constant 120 VAC.)
WARNING:
Failure to properly supply line voltage to the C-arm mobile stand may result in
damage to the system’s electronic components. Wired for 120VAC @ 20 amps
WARNING:
Never disconnect the Mobile stand when it is already connected to the power supply
and switched on.
Damage to the electronics of the system cannot be excluded if this warning is ignored!
WARNING:
Never operate the C-arm system if inclination of the floor exceeds 5°. Death or
serious injury may result if the ZIEHM QUANTUM is operated with a tilt of greater
than 5°
WARNING:
Do not operate the system until the equipment has reached a safe operating temperature
of +15°C to +35°C with no condensation present. Otherwise severe equipment damage
may result.
The C-arm stand has two buttons for switching the system ON or OFF See Fig 4.2 for location of
the two switches. Buttons numbered 3 and 4.
• Make sure that the inclination of the system does not exceed 5° from the
level in operating position.
• Ensure that all electrical connections are properly established.
• Put on suitable protective clothing.
• Switch on the system using the Power ON buttons on the mobile stand
C-arm. The button switches on or off all the systems components
simultaneously.
4.5.2 CONFIGURATION
You have the possibility to adjust various basic and operation settings so as to meet your special
working requirements. If these settings have not already been made at the factory, you can make
them yourself by entering the File, then entering the Configuration operating mode.
NOTE
Please contact your service engineer if you wish to make modifications to the initial
settings
4.6.4 PERFORM THE FOLLOWING OPERATIONAL TESTS & VERIFY THAT THE
FOLLOWING RESULTS OCCUR:
1. During fluoroscopy, the live image appears on the left monitor.
2. When exposure occurs (either during fluoroscopy or radiography) the amber light on top of
the left monitor lights up, and the radiation indicator on the C-Arm control panel lights up.
3. Open and close the slot and iris collimators. (Perform Collimation test with Fluoroscopy
on)
4. After fluoroscopy is completed, the last image is held.
5. Rotate the slot collimator during radiation to make sure it is operational.
6. Reverse the image.
7. Rotate the monitor image using the Image rotation buttons on the touch screen control of
the DESK VIEW.
8. Select manual kV mode. Press hand switch to start radiation, while radiation is on press the
kV up key, the kV value must change.
WARNING:
To prevent the camera from being over-driven by high light-levels, do not perform
fluoroscopy in the kV manual mode at a kV levels higher than needed.
4.7 ACCESSORIES
Depending on the integrated options, the following accessories are included in the scope of
delivery:
WARNING:
The monitors must be placed in the transport position with all locks engaged
before transporting the ZIEHM QUANTUM C-arm mobile stand.
Failure to lock all the ZIEHM QUANTUM c-arm locks and monitor support
arm pivot locks as show in Fig 5.2 may result in serious injury to patient or
operator.
CAUTION
System should never be operated on floors with an inclination greater than 5°
from level. This applies to the C-arm stand with the monitors in the locked
operational position. The system must be in the proper operating position
before use.
Exercise extreme caution when moving the mobile C-arm stand that the cable
guards do not drag and the wheels do not catch or tilt causing damage to the
equipment.
CAUTION
Do not move the system over floors with an inclination of more than 10°
from level during transport. This applies to the ZIEHM QUANTUM C-arm
mobile stand.
Exercise extreme caution when moving the ZIEHM QUANTUM mobile C-
arm stand over rough surfaces such as tile flooring, concrete pavement, or
carpet. Take care that the cable guards do not drag and the wheels do not
catch or tilt causing damage to the equipment.
Exercise extreme caution when moving the ZIEHM QUANTUM mobile C-
arm stand over rough surfaces such as asphalt paving as this will cause
damage to the wheels.
WARNING:
Operate moveable assemblies and parts with caution.
Exercise extreme caution when releasing mechanical locks or brakes. To
prevent unwanted movement of the mechanical c-arm assembly, always
maintain control by holding on to the mechanical component and then slowly
releasing the mechanical lock(s) before moving any of the mechanical
components of the ZIEHM QUANTUM mobile C-arm. Failure to observe
this warning may result in serious injury to patient or operator.
WARNING LABELS
Labels are mounted and visible on the monitor arm and pivot lock areas.
NOTE
Make sure all monitor pivot locks are correctly set for operation of the mobile
stand. Placement of the monitors on the right or left side of the mobile stand will
require that the locks be set correctly for right or left operation.
CAUTION
Release the parking brake only to move or position the C-arm.
Operate moveable assemblies and parts with caution.
Exercise extreme caution when releasing mechanical locks or brakes. To prevent
un-wanted movement of the mechanical c-arm assembly, always maintain control
by holding on to and then slowly releasing the mechanical locks before moving any
of the mechanical components of the ZIEHM QUANTUM mobile C-Arm. Failure
to observe this warning may result in serious injury to patient or operator.
Fig 5.3: C-Arm Stand Steering (schematic representation, view from above)
CAUTION
Before moving the C-Arm, make sure that there is nobody within its range of
movement.
WARNING
Release the mechanical brakes only for positioning.
Make sure there is enough room to maneuver the C-arm stand and Monitor
assembly before positioning!
Exercise extreme caution when releasing mechanical locks or brakes. To prevent
unwanted movement of the mechanical c-arm assembly, always maintain control
by holding on to and then slowly releasing the mechanical locks before moving
any of the mechanical components of the ZIEHM QUANTUM mobile C-arm.
Failure to observe this warning may result in serious injury to patient or operator.
5.3.2 ANGULATION
The C-arm can be rotated by ± 225° in the vertical plane around the horizontal axis (i.e., the
horizontal carriage). A scale with 10° divisions is provided at the pivot joint of the horizontal
carriage to facilitate precise positioning.
NOTE
Rotation Brake for angulations is on the horizontal arm of the Mobile stand See
Fig 5.1
When using the Swivel or Panning function for the c-arm you may need to reposition the
monitors for a clear view of the image displays.
5.3.4 HORIZONTAL MOVEMENT
You can move the C-arm forward and backward by 22 cm in the horizontal plane by means of the
horizontal carriage. A scale with 1 cm divisions is provided to facilitate precise positioning.
CAUTION
Before pressing the override switch and lowering the C-arm further, make sure that it
does not collide with any persons or objects!
CAUTION
Before moving the C-arm up or down, make sure that it does not collide with
any persons or objects!
NOTE
The DeskView touch screen offers automatic display of relevant buttons and
removes all but the buttons not relevant or operative for any individual mode, or
functional process.
When radiation is active only those functions that are available during the exposure on time will
be visible and accessible. See figure 6-3 for example of main touch screen with Fluoroscopy
selected and radiation on.
The Buttons will have two states of operation:
• Inactive or off state; Button is light gray and is available for selection
• The active or on state; Button is yellow to indicate the active state, in some cases the text
will change with the toggling of the button through several states.
Example; in this case the noise reduction button has four (4) states (Off, Low, Med and High)
Inactive Active
The Main screen elements of operation are shown in the figure 6-1,
Technique Display
Manual KV
Reference
Patient Demographics Live Images
Image
Patient File
Selections,
Display
Login HIPPA Image
Parameters
Mag Select
Collimator
Fluoroscopic
Anatomical
Programs Store
Functions
Cine DSA
modes
Button 4 Log In
Activates the Log In Screen for password
protection for storing and send images from
patient file to external storage devices, i.e.
DICOM server/printers, USB memory sticks,
or DVD writer.
Provides security of patient file records
(images) from being removed without
permission (HIPAA)
Button 8 Zoom
Pressing the Zoom button will open a digital
magnification window on the left monitor
and display on the right monitor the
magnified image.
Button 25 Metal
Activates the metal artifact correction
function.
This supplementary to the organ program
image quality.
Button 28 Store
Stores the active live image to the hard disk
Operator can press Store button during live
fluoroscopy to store image on the fly.
Button 47 Manual KV /
Pressing the Manual kV button will lock the
technique at the time you press the button
To increase or decrease the kV level press the
up or down arrow key when they are
displayed
The function/buttons that are not relevant to modes of operation and during radiation are removed
from the screen to assist the operator in making and effecting easier control decisions.
NOTE
In certain modes, function buttons may not be active and therefore will be
removed from the active screen.
NOTE
It is not possible to press two keys on the keypad simultaneously. To combine a key with
the Shift key, first press and release the Shift key and then the desired key.
To deactivate the Shift mode, press the U-Shift key before entering the letters or
characters.
Button 4 Power ON
Activates power on circuits
Button 13 kV Adjustment
Press the up button to increase the kV level
Press the Down button to lower the kV level
Button 20 Radiography
Sets the system into the radiographic mode of
operation.
Optional setting for this function. May not be
available on all systems.
Button 24
Image Mirror
The Image mirror buttons do not work on this
keyboard, to mirror image use the Desk View
touch screen image mirror button
Not Active
Button 25
Left Monitor
Not Active. Touching this buttons will not
activate any function.
Not Active
Button 26
Right Monitor
None active touching this buttons will not
activate any function
Not Active
Button 28
Button 31
Image Transfer
Pressing this button will not activate
functions
Not Active
Button 32 Metal
Activates the metal artifact correction
function.
This is a supplementary operation to the
organ program image quality.
Button 33 Soft
The Soft button has been reprogrammed to
penetrate larger patient anatomy ( Adipose
patients) and is called “LPD” on the Desk
View touch screen
See also Button 29
Button 34
Window/Level
Will not activate a function, this button is
blocked
Not Active
Button 38
Dose Area Product (Option)
USED ONLY FOR ERROR CODE READ
OUT in the UNITED STATES
See Desk View Touch screen for AKR dose
USED ONLY FOR ERROR display.
CODE READ OUT
Button 40 Thermometer
Thermal indicator, will light up when the
system has reached maximum level of
thermal loading.
ON OFF
CAUTION
Do not touch the touch screen during start up as system operation may be
effected, and improper start up may occur.
If this occurs turn off the unit and restart the system, remembering to not touch
the screen during power up sequence.
CAUTION
Do not insert a CD/DVD disk into the CD/DVD writer or USB Memory
devices into the USB interface until after the system has fully completed its
power –up sequence. Failure to follow this caution will result in the system not
being fully functional.
NOTE
Always set the ON/OFF switches on the flat-screen monitors to ON in the
order to ensure that the monitors are switched on automatically during power-
up of the system.
OFF
CAUTION
Before pressing the override switch and lowering the C-arm further, make sure
that it does not collide with any persons or objects!
CAUTION
Before moving the C-arm up or down, make sure that it does not collide with
any persons or objects!
Radiation is initiated either with the hand switch or the fluoroscopy pedal of the foot switch.
The standard pedal assignment of the two-pedal foot switch is as follows:
− Left pedal: Fluoroscopy
− Right pedal: Save/Store image (OPT: Laser and snapshot)
• Optional two settings can be made:
o Laser on/off
o Snapshot mode
NOTE
The foot switch pedals can be assigned with three individual customer-specific
functions. If second footswitch is active the respective function will be indicated on
labels on the foot switch itself and on the C-arm stand.
the C-Arm video camera. Images are displayed on two high-resolution, TFT LCD, antiglare
monitors.
Proprietary software improves image quality by:
• Reducing noise
• Acquiring images at a true 14-bit grayscale
• Digital acquisition image matrix up-scan to a 1K2 Image with 980 x 980 active pixels.
• Digital display of 1024 H x 1280 V
• Real-time edge enhancement.
The image can be manipulated, stored, or displayed onto the monitors. Images that have been
saved to the hard drive can be edited (enhance edges, Widow and level, Invert image, etc.).
7.7 FLUOROSCOPY
Using the ZIEHM QUANTUM to perform fluoroscopy is easy: turn the system on, give the
cathode filament and image system around 45 - 60 seconds to warm-up, when desk view control
buttons are displayed on the touch screen just press the hand switch or foot switch to start
radiation and view the first images!
The following are some of the standard and optional features, described in detail later in this
chapter, are also available:
• Several fluoroscopy programs
• Snapshot technique
• Pulsed fluoroscopy
• Manual control of kV
• Image integration for noise reduction
• Image Magnification
• Store image to patient file
• Image reversal
• Digital Image rotation
• Iris collimation
NOTE
Any adjustments that are applied to a live image on the live monitor remain valid
for all subsequent live images until you choose other settings.
NOTE
Any adjustments that are made to a recalled or none live image will only apply
to that image and will not apply when radiation is started again.
NOTE
When you save an image, it will be saved with all rotations, reversals, filter
settings, and markers, etc. All the modifications to the live image when stored
are visible when the image is displayed as a thumbnail in the mosaic.
NOTE
When you save an image, it will be displayed on the reference (right) monitor as
a thumbnail image on the lower part of the screen as well as on the larger display
area.
Fluoroscopy
Pulse
Snap Shot
Time from Hand foot switch activation
In pulse fluoroscopy mode, the system emits radiation pulses as long as you press
the radiation hand or footswitch. Rate < 3 F/sec.
The pulse rate is fixed. The lower the pulse rate setting, the lower the radiation dose per second.
Pulsed fluoroscopy reduces the effective dose rate. Press the Pulsed Fluoroscopy button on the
mobile stand and then press the hand or foot switch. Radiation is released for an interval of time,
approximately, one to maximum of 3 pulses per second depending on program time set for
pulses.
Press the Fluoroscopy button on the mobile stand keyboard or press the Pulsed Fluoroscopy
button on the touch panel to return to standard fluoroscopy. When programmed by a service
engineer, pulsed fluoroscopy can make up to three pulses per second.
• Please contact your service engineer if you wish to set or modify the pulse rate factor.
7.9.2 SNAPSHOT
In snapshot mode, the radiation time does not depend on how long you press
the radiation switch. For each organ program, a specific AERC characteristic
is stored on the system for the Snap Shot or digital radiography mode. The
fluoroscopy parameters are adjusted using the respective AERC characteristic,
and radiation is terminated automatically afterwards.
The snapshot mode is suitable for examinations involving no patient
movement. The aim of snapshot mode is to generate high-quality static
images, e.g. for printing / documentation purposes.
NOTE
Snapshot is only activated by the hand switch; it is not activated by the foot switch.
Unless optional footswitch programming has been activated.
NOTE
When you activate the Snapshot mode, certain touch screen buttons will
disappear from the touch control panel depending on the system options.
The following organ programs are available on the Touch Screen and the Mobile stand Keyboard:
7.10.2 BONE/EXTREMITY
The Bones organ program is optimized for visualizing any part of the human
skeleton. It is used mainly in orthopedics.
7.10.3 PELVIS/ABDOMEN
The Abdomen organ program is optimized for visualizing any organ in the
abdominal region. It is used e.g. in urology, for cholangiographies and for
preparing dilatations and implantations.
7.10.4 HEART/THORAX
The Heart organ program is optimized for visualizing the heart and the thorax.
It is used e.g. in heart surgery, pacemaker, and dilatations in the heart region.
The metal artifact correction function corrects a possible flaring of the fluoroscopic
image resulting from metal objects in the beam path and increases contrast at tube
voltages above 50 kV.
The metal artifact correction function can be combined with each organ program.
In the case of collimation using the Slot or Iris collimator using the METAL button
may help restore the black level in the image.
WARNING
To protect the health of patients and staff against high radiation dosages, the
manual dose rate setting mode remains blocked until you have initiated radiation
in one of the fluoroscopy modes with automatic exposure rate control at least once.
Only use the manual exposure rate setting mode in exceptional circumstances.
The automatic exposure rate control provides optimum image quality whilst
minimizing the dose rate.
• Press the Manual Exposure Rate Setting button on the mobile stand
and touch screen control keyboard. The kV value that has been
automatically determined is saved for subsequent fluoroscopic
initiations, and the system switches to the manual mode.
NOTE:
AKR dose display is not active and is not displayed on systems manufactured before
June 2006.
Dose Air
Kerma
Radiation
Indicator
Active
Live
Image
Store
8.1.1 METAL
If any metal is in the path of the x-ray, the displayed image will be too bright
and patient detail will be lost. To compensate, press the Metal button on the
DeskView or Mobile Stand Control Panel to add contrast to the image.
The Mag button LED on the mobile stand will illuminate to show that zoom is
on. Systems that have the optional Triple Mode image intensifier can zoom 1.5
and 2.0 times.
NOTE
Mag 2 function is only available with Optional purchase of the three mode image
intensifier.
The DeskView Touch Panel Image Rotation buttons are active with the
live monitor and removed for certain modes and functions where they are
not active for that mode or function.
The Mobile control keyboard image rotation buttons are operational for
left and right monitor rotation. Only with ZQ_Global version < 2.50.
NOTE
With Version below ZQ_Global 2.5.0 The user may notice that if both buttons are
pressed that the image will continue to rotate in CCW or CW direction and can be
stopped by simply pressing either the CW of CCW rotation button momentarily.
The Touch Panel Image Mirror button is active with the live monitor and
is removed from the DeskView touch panel when certain modes and
functions would not be active in that mode or function.
The two Image Mirror buttons on the mobile stand are not operable on the
ZIEHM QUANTUM.
To open the Iris Collimator, press the Iris Collimator Open. Each press opens
the collimator one step. To make a larger adjustment, press and hold the button
down to advance through several steps.
To close the Iris Collimator, press the Iris Collimator Close button. Each press
closes the collimator one step. To make a larger adjustment, press and hold the
button down to advance through several steps.
To fully open the iris, briefly press both buttons simultaneously on the mobile
stand control keyboard.
To open the Slot Collimator, press the Slot Collimator Open button.
To close the Slot Collimator, press the Slot Collimator Close button
To rotate the Slot Collimator clockwise, press the Slot Collimator Clockwise
Rotation button
Mark Image function turns on the “R” for right or “L” for Left anatomical
marker. The display is located in the touch panel display on the upper left
corner of the live image display. On the main display monitor the "R" and "L"
marker is displayed on the left monitor. Pressing the "R" or "L" button several
times will cycle the "R" and "L" makers on and off. Turning the “R” or “L”
maker display off will remove the Right (R) or Left (L) marker off.
NOTE
Live Swap should not be activated when the system is making radiation. Image flash
may appear.
8.9 MONITOR L TO R
8.10 MONITOR R TO L
Press one of the four Image Icon’s on right side of the touch screen once to
select image and recall image to the right monitor then touch the image icon
a second time after a 1/2 to 1 sec delay to transfer image from the reference
or right monitor to the live or left monitor.
In certain conditions the transfer function may not be active for particular
modes or functions.
Press the INV Video button to reverse the light and dark areas of the image and
create an image that resembles a film negative.
The effect can be changed latter by recalling the image and pressing the INV button
again.
When you press store button the image will be stored with the INV image attribute
so the image will be recalled with the Black and White levels inverted.
Fig 8.1: Fluoroscopic radiation with Invert on and Dose display /rate
8.12 STORING/SAVING
CAUTION
When the hard disk is full, the system will give a message that you need to delete patient
images to free space on the hard disk.
Before saving an image, make sure that there is enough free hard disk space, and
regularly back up the patient folders which are still needed on external storage media or
on a DICOM network.
To store/save the last image displayed on the live monitor to the active patient
folder:
• Press the Save button.
Each stored /saved image automatically receives an image number. These
Image numbers are assigned and incremented consecutively for each separate
patient folder.
Unsaved images (those without a number) will be replaced by a new
fluoroscopic image during the next fluoroscopy.
Images can be stored to the system hard drive. When you press the Image
Store button, the image on the Live/left monitor will be stored and copy of the
image as a small Thumbnail will be display on the reference or right monitor
and on the touch screen. Image number will be assigned to the image.
Use Image Store to:
• Save a live fluoroscopic image, Store on the Fly
• Save the last image held on the left or live monitor
NOTE
When storing images during Radiation (Live fluoroscopy) the images will not be
displayed on the touch or the reference monitors until the fluoroscopic hand or
footswitch is released. This will take a few seconds depending on how many images
were stored during live Fluoroscopy.
The system can store images directly to an external Ziehm Imaging, Inc. certified
USB storage media. To store to the external USB media memory device you must
first insert a certified USB memory Stick/Device, Thumb drive memory device, or
USB mini thumb drive memory device.
When you have an image that is ready to be stored just press the USB button on
the main Touch screen to store the image directly to the USB device
When you store an image to the external USB memory device the system does not
make a copy to the system hard drive as a back up to the external image.
NOTE
User must Log In to the system before USB memory devices can store images. The
system incorporates a feature of protection from unauthorized user removing medical
images from the system.
NOTE
As there are many different types and sizes of USB memory media, and each
different make and model requires different software drivers, to allow use of all
makes and models of USB device is impossible. Therefore, Ziehm Imaging, Inc.
will not guaranty that all USB media memory device will be compatible.
Please contact Ziehm Imaging, Inc. for list of certified USB devices. Ziehm
Imaging may at its convenience supply at time of delivery a list of certified devices.
WARNING
Do not touch the USB or DICOM ports and Patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
Accessory equipment connected to the analog and digital interfaces must be certified
to the respective IEC standards (i.e. IEC 60950 for data processing equipment and
IEC 60601-1 for medical equipment.) Furthermore, all configurations shall comply
with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the system
complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical
services department of your local representative.
E 62 5.15
8.14.1. KV DISPLAY
The default setting is 75 kV. During fluoroscopy, the ZIEHM QUANTUM adjusts kV levels
automatically using dose rate control circuitry, unless manually overridden. After fluoroscopy,
the last kV value used is stored in the system and is shown in the kV section of the display
window. See left display window above for sample of display values.
8.14.2. MA DISPLAY
The ZIEHM QUANTUM controls mA level in relation to kV level. The mA value is displayed
in the left window during live fluoroscopy.
The last value used by the system is stored and recalled when the system returns to fluoroscopic
mode. This value will continue to be used until either new kV values are entered or until a new
operating mode is selected. See left display window above for sample of display values.
8.14.3. EXPOSURE TIME(S)
In Radiographic mode, the system sets the current to 20 mA and an exposure time from 0.1 to 4.0
seconds can be selected using the Up/Down Arrow button. This exposure time is then stored and
displayed. See left display window above for sample of display values.
8.14.4. CGYCM2 / ERROR
The cGycm2 display window has two functions one to show dose area product value in Grays.
The other function provides the user with a way to see system error codes. The dose display
function is not operational on the U.S. models. The error codes however will be displayed in this
window. See right display window above for sample of display values.
Fluoroscopy and radiography time are displayed in minutes and seconds. Every five
minutes of fluoroscopic time an alarm will sound to warn the user that 5 minutes of
fluoroscopic time has elapsed. This will continue every five minutes. The sound will
not stop until the operator reset the alarm.
After five minutes of radiation have accumulated, an alarm is triggered and an LED in
the Min button begins to flash and the Reset Timer button turns red on the DeskView.
To turn off the alarm, press the Min button on the mobile stand or the Reset Timer
button on the DeskView touch screen. The LED and the Reset button will continue to
flash on the mobile stand; the touch screen button will turn red. To turn off both the
alarm and the LED, press and hold the Min or Reset Timer button.
CAUTION
If you do not switch off the alarm after 30-60 seconds max., radiation could be
terminated automatically (Can be set by service technician)
WARNING FUNCTION
In order to prevent radiation from being accidentally generated over a long time, the
system has a warning function. After each 5 minutes of elapsed total radiation time,
the system issues an interval warning at every 5 minutes of fluoroscopic time
accumulated up to maximum of 99 minutes.
NOTE:
Pressing and holding the Min/Reset Timer button for more than 2 seconds clears both
Radiation Timer and the Dose displays on the control panel and touch panel indicator
displays.
NOTE:
Systems are programmed to continue operating fluoroscopy until the maximum heat
overload is reached, and then turn off fluoroscopy. The indicator will flash as the
generator begins to overheat but, when the generator reaches the maximum heat limit,
it will automatically turn off fluoroscopy.
−The X-ray symbol on the Desk View touch control panel is illuminated when
radiation is being released. The Radiation Exposure indicator is located in the
right upper area of the touch panel. The symbol on the touch screen is only
visible when radiation is on. In the case of Pulse Fluoroscopy the Desk View
Radiation indicator will be on all the time. There may be times where this
indicator will be on longer and come on a bit latter than the other two radiation
indicators this is normal.
−The third X-Ray symbol radiation indicator is located on the Mobile Stand
control keyboard on the right side in the technique display area. The indicator is
illuminated when radiation is being released. In the case of Pulse Fluoroscopy
the Radiation indicator will pulse with the radiation on time.
NOTE:
The Radiation lamp indicators may not all come on at the exact same time. There can
be a very short time period just before and after radiation is on, this is normal and is a
result of having three separate back up indicators for the system.
There can be some cases where the radiation indicators are on but the radiation is not
active. In these cases it would indicate a failure in the system and would require re-
starting the system. If this occurs again after turning on the system and performing
radiation, the operator should then call for service repair.
8.15.1. kV:
Displays will show the kV of the system both in automatic and manual kV selection modes of
dose control.
8.15.2. mA:
Displays will display the selected mA for both Fluoroscopic and radiographic exposure modes.
8.15.3. S or Seconds:
Displays for the radiographic exposure time.
8.15.4. Min:
Displays the actual fluoroscopic accumulated time.
8.15.5. mGy / mGy/min: (Active only on system manufactured after June 10, 2006)
During the exposure, the air Kerma rate display showing the current air Kerma rate in
mGy/min. appears on the control panel. Accumulated air Kerma readings of the fluoroscopy,
pulse fluoroscopy and radiographic exposure modes are displayed when ever the user releases
radiation.
8.16 LASER AIMING DEVICE
As an option, the system may be equipped with a laser targeting device at the image
intensifier and/or generator.
The laser targeting device uses diode laser modules which emit laser radiation. Do not
under any circumstances look directly at the laser beam or any scattered laser
radiation – either with the naked eye or with optical instruments.
The laser targeting device is a Class 2 laser product according to IEC 60825-1:2001.
and FDA 21 CFR, Subchapter J, Section 1040.10 - 11
NOTE:
The laser is a class II laser product, subject to 21 CFR Subchapter J, 1040. Its
peak power is <1 mW, and operates at a wavelength of 635 nm.
You must comply with all operating safety precautions when using the laser device. The
maximum output of continuous laser radiation, measured at the beam exit, is <1 mW. The
wavelength of the emitted radiation is 635 nm.
The laser Aiming device generates a laser-beam crosshair, the central point of which marks the
position of the central X-ray beam on the patient.
For safety, the laser targeting device is switched off automatically after 1 minute.
Laser Class II in accordance with FDA 21 CFR, Subchapter J, section 1040.10-11.
Please observe the provisions of IEC 60825-1:2001, Section 3, “Guidelines for the User” for
operation of the Laser Aiming device.
WARNING:
DO NOT stare into the laser beam! Eye damage may result! The use of optical
instruments with this product increases eye hazard.
Press the Laser button. A laser-beam crosshair is generated, the central point of which
corresponds to the position of the central X-ray beam.
Position the C-arm in such a way above the patient that the central point of the laser-
beam crosshair is exactly in the center of the region to be screened.
CAUTION:
Not resetting the dose display just before starting a new exam on a new patient can
result in incorrect dose reading for that patient.
NOTE:
The Dose value stored for each image will be the accumulated cGy dose value of the
system at that moment the store button is pressed. This means each image stored will
have a different total accumulated value for dose.
The last image stored by the user will have the highest dose value associated with it,
but not necessarily the maximum dose value for the complete patient exam.
NOTE:
Re-storing a previously stored image after post processing will not change the dose
value associated with the image.
NOTE:
During Snap shot and Pulse Fluoroscopic imaging the system will display the AKR
value during the exposure; however there may be some flicker to the display as the
pulse operation and the snap shot operation do not allow enough time for the display
to become steady during radiation on. The cumulative values will be displayed with
in 5 seconds after releasing the radiation switch.
NOTE:
Pressing and holding the Min/Reset Timer button for more than 2 seconds clears both
Radiation Timer and the Dose displays on the control panel and touch panel indicator
displays.
NOTE:
The air Kerma display can also be automatically reset when a new patient file is
selected; this option is selected in the system configuration screen.
Press the RTE button toggles between RTE Off, Low, Med, and High, edge sharpness.
1 = Off
2 = 10 %
3 = 20%
4 = 30%
Once pressed, the monitor displays the message “EDGE” in the live monitor. Best results are
obtained when a noise level of at least Edge 1 is used.
The amount of noise in fluoroscopic images can be reduced by three levels: NR Low, NR
MED, and NR HIGH. The Noise button can be pressed before or during fluoroscopy.
Noise reduction is accomplished by using weighted frame averaging of the current and
previous images, which may cause an increase in image lag-time in the video display. It
is not a post-processing function and cannot be used to change a previously stored image.
When the Noise button is pressed, the message “NR LOW, NR MED, and NR HIGH” is
displayed in the left monitor.
The LIH Noise reduction function reduces noise in the image when the radiation switch
is released. It is used to reduce noise and distortions that arise from the movement of the
C-Arm or patient during a fluoroscopic procedure. It is not a post-processing function
and cannot be used to change a previously stored image.
The system may be configured to apply low noise reduction for live images and a higher
level of noise reduction when the foot switch is released.
There are four LIH setting available: LOW, MED, HIGH, and OFF. If you do not wish
to have the image displayed on the monitor after the foot switch is released, press the
LIH Noise button several times until the message “LIH OFF” is displayed on the right
monitor and the button is not highlighted in yellow.
NOTE:
The LIH function can be set to a default value in the Service Menu. This must be
performed by certified Service personnel.
The Auto function has two modes of operation. You can configure the ZIEHM
QUANTUM so that a new image will be stored or transferred automatically as soon as
you terminate radiation.
Simply press the Auto Function button to open all the auto functions available for the
particular system configuration.
NOTE:
Some of the Auto functions may not be available depending on the configuration of
your system and optional features that may or may not be available on a particular
system model.
NOTE:
Auto Store function will automatically store image to the hard drive and
transfer image to the reference or right monitor as part of the auto store
function
NOTE:
Any adjustments which are applied to a live image on the live monitor remain valid
for all subsequent live images until you choose other settings.
NOTE:
Any adjustments which are made to a recalled or none live image will only apply to
that image and will not apply when radiation is started again
NOTE:
When you save an image, it will be saved with all rotations, reversals, filter settings,
and markers, etc. All the modifications to the live image when stored are visible
when the image is displayed as a thumbnail in the mosaic
Pressing the W/L button changes the contrast of the video image by changing the
window of gray scale. It modifies the brightness of the video by changing the level of
brightness within the window of gray scale.
When the W/L button is pressed, the Live and DeskView displays the values in
relative numbers to the level set.
double tap the image on the DeskView to have it become the active image.
3. Press the W/L button. The system will open the adjustment buttons. Use the function
buttons to adjust the image contrast and brightness level to a relative image level. The
image can then be stored to the hard drive, transferred to the right monitor, USB device or
DICOM server.
4. Press the Reset W/L button to return the image to its original contrast and brightness
levels.
5. To save the new window and level values as the new defaults for image display press the
Save W/L button.
6. To exit the Window Level function, press the W/L button again or one of the other post
processing buttons to close W/L and open the new function.
8.20.2. INVERT
The INVERT Video function can be used with both stored images and real-time flu-
oroscopy.
Press the INVERT Video button to reverse the light and dark areas of the image and
create an image that resembles a film negative.
The effect can be changed latter by recalling the image and pressing the INVERT
button again.
When you press store the image will be stored with the INVERT image attribute so the
image will be recalled with the Black and White levels inverted.
The Image CROP function collimates the image systems electronic shutters to CROP
out unwanted parts of the image.
4. To increase magnification four times, press the 4X button. The window on the left window will be
smaller, representing the area on the reference monitor.
Press the ZOOM button or press ESC to exit the function. The right monitor will continue to display
the last magnified image.
Magnified images can be stored to the hard drive or USB storage device by pressing the
respective store function. The operator can store the image to the patient file as a magnified
image and can be recalled latter and exported.
Move the activity box to the desired image by touching the Thumbnail Icon Image or press the
page Image Scroll Arrow buttons to view the next four images of the patient file.
8.21.3. DELETE IMAGE (ACTIVE ONLY WITH SYSTEMS HAVING SOFTWARE VERSION
2.5.0 OR ABOVE)
Deletes a single image or CINE run from the patient file.
Use the page Image Scroll Arrow buttons to open the next four images or if already on the
screen touch the Thumbnail Icon Image to highlight the Image with the selection box menu. Once
the image is highlighted by the selection box just press the Delete button to delete the selected
image/or run.
No message is given for a single image delete operation
Confirmation Message is displayed for user when deleting a Cine/DSA run, the user must
confirm delete request before the system will delete Cine/DSA run
8.21.4. STORE TO OR MAKE A COPY OF AN IMAGE
Copies images from patient file to USB or DICOM storage devices.
Place a Ziehm Imaging, Inc. Certified USB storage device in the USB port located on the front
of the mobile stand. Select the image by using the Image Scroll Arrow buttons to highlight the
image then press the store to USB or Send to DICOM button.
(Availability of these two functions depends on system option configuration)
The Left monitor is normally the live monitor and the Right monitor is normally the reference
monitor.
In certain circumstances such as when LIVE SWAP button is active then the right and left
monitors switches display functions and the live function display is on the right.
This mode of LIVE SWAP is used when the operator needs to view the monitors from either the
right or left side of the image intensifier. The LIVE SWAP allows the technologist to switch the
live monitor display to the outside monitor for better viewing.
NOTE:
To avoid confusion, the neutral terms ‘live monitor’ and reference monitor’ are used
throughout this manual, regardless of your custom setting.
Fig. 8.7: Fitting The Film Cassette Holder And Inserting The Film Cassette
Image Intensifier
Securing lever
Film cassette holder
Film cassette
WARNING:
Make sure that the film cassette holder is properly attached to the image intensifier
that the cassette cannot fall down onto the patient
NOTE:
To avoid confusion, the neutral terms ‘live monitor’ and reference monitor’ are used
throughout this manual, regardless of your custom setting.
Fig 8.8: Main Screen Radiography Operating Mode, DeskView Touch Panel.
• Initiate radiation using the hand switch. In the Radiography operating mode,
you cannot initiate radiation with the foot switch.
An audible alarm will sound throughout the entire exposure time. Radiation is
terminated automatically after the preset exposure time. You can interrupt the
exposure before the selected exposure time has elapsed by releasing the hand
switch.
• Withdraw the film cassette.
• Remove the film cassette holder from the image intensifier.
• Process image.
NOTE:
Adjustment of exposure factors will result in different image quality, adjustment of the
technique factors maybe necessary to archive a good quality image
MSA
The MSA buttons of the Mobile Stand is not functional
RSA
The RSA button of the Mobile Stand is not functional
6. The system starts acquiring the image “Mask” at this time the kV/mA is locked
7. After the “Mask” is acquired, the system displays the real-time image on the reference
display monitor. The subtracted image will be displayed on the live display monitor. When
the DSA image is displayed on the live monitor, Operator starts injection and the display
shows the contrast media as it is injected. The system will capture at the selected or default
rate.
9. When you have obtained the desired imaging, release the hand or foot switch. The acquired
images will automatically replay in a continuous loop, until you either exit DSA or start a
new acquisition. This takes a few seconds to start the replay.
10 To exit DSA mode, press either the DSA button again on the DeskView Control Panel, or
press one of the Fluoroscopic mode buttons.
Only the subtracted image will be displayed during capture and replay. The user cannot remove
the mask from the DSA.
To change the capture or replay rate use the Frame Rate button to
change from 1 to 15 f/sec
NOTE:
During acquisition, image intensity and contrast looks different than during normal
fluoroscopy and is normal for the images to look this way. The contrast and brightness
and Gamma curves are set to provide better visualization of the contrast media during the
image capture in DSA.
NOTE:
All Cine/DSA Image Acquisitions are Protected. The ZIEHM QUANTUM protects all
sequential image acquisitions (DSA, Cine Studies) are automatically stored to the Hard
Drive for immediate review of the image sequences or can be recalled at a latter time.
NOTE:
When performing DSA image acquisitions it is important to make sure the patient does
not move. The motion of the patient will disrupt the image quality.
The CINE function selects the dynamic acquisition mode for acquiring and
replaying images in a sustained sequence. Images can be acquired at a rate of 1
to 15 fps, and can be replayed at either 1 to 15 fps, depending on the optional
software. Images acquired at 1 to 15 fps are stored directly to the hard drive.
When the CINE function is selected, the system does not change its image
properties. The C-Arm stays in the fluoroscopic body region that was selected.
The CINE function allows the operator the ability to perform procedures such as
Cholangiography, Barium Swallows, Urinary Studies, ERCP, or any procedure
that requires a sequence of images to be acquired without DSA.
To make room on the hard drive, delete Cine, images, or DSA image runs, or patients from the
system.
To exit the CINE function, press the CINE button to close the function and return to normal
fluoroscopic operation.
NOTE:
All Cine Image Acquisitions are protected. The ZIEHM QUANTUM protects all
sequential image acquisitions (Cine Studies) they are automatically stored to the Hard
Drive for immediate review of the image sequences images.
The CINE Button will be highlighted on the DeskView screen and the selected frame rate
will be display on the touch screen.
3. Press and hold the hand or foot switch. The left monitor will display the message
“INJECT” in the lower center of the screen to indicate that the system has started capture of
images.
4. Start the injection of contrast media.
5. Continuing holding the exposure switch until the desired vascular anatomy has been
visualized.
6. The acquired images will begin to play back in a continuous loop from the hard drive or
from memory, depending on frame rate selected and the system’s optional equipment.
9.7.1. ACQUIRING A NEW CINE RUN
If scout fluoroscopy is necessary between runs, press the CINE button to exit and return to
normal fluoroscopy.
Repeat the Cine procedure above. To acquire another study /cine run
1. Press one of the Contrast buttons on the Mobile Stand Control Panel or the Arrow
playback buttons on the DeskView Control Panel. This places the system into a playback
mode that steps through images one at-a-time.
1) The message “F/R OFF” will display in the upper right corner of the monitor,
indicating that the image loop has stopped and that the operator can now step
through the images.
Press either button to step through the images. Hold down either button to step
through the images at nearly the selected frame rate.
2) When image playback has stopped, select the image to transfer to the patient file
and press either of the Image Store buttons.
3) The message “Stored to XXXX” is displayed on the left monitor which indicates
that the image has been copied to the patient file as image number XXXX.
File Screen allows the user/operator to perform many different functions that are related to patient
records. The user/operator may add then select any of the patients in the data base and perform
the following operations;
1) WORKLIST allows the user/operator to select via a DICOM server connection the
patient list and load the patient names into the system database.
2) EDIT/MODIFY allows the user/operator to edit/\modify the patient record (name, ID,
etc ) for a patient that has already been entered.
3) PATIENT SEARCH allows the user/operator to search the data base for a patient record
using the Patient Name, ID, Accession Number, or Procedure.
4) PROTECT allows the user/operator to protect a patient file from deleting or changing
unless they choose to override this protection
When you need to select a different patient from the present active patient file the user should
open the file screen, then using the PATIENT SCROLL arrow keys or the Right side File
selection SCROLL BAR to locate the patient file/record that you would like to make the active.
Once you have located the patient record simple touch the patient record line on the file screen or
use the PATIENT SCROLL arrow buttons to move the patient record then stop. The system will
then if selected by touching the patient record line or stopping on the patient record will try to
recall images from this record and then display the patient name and images on the display
monitors.
To make this the active patient press the ENTER button on the right side of the text entry
keyboard. The system will then make this the active patient close the file screen and return ot the
Main Screen.
The patient is now active and all image stored will be placed in this patient record for exporting
or printing.
Closing the file without selecting a new patient:
The user can select different patients and their images by selecting them from the file list without
leaving the file screen. However, if the user does not want to make the newly highlighted file the
active patient and wishes to return to the original patient before entering the file screen they must
press the EXIT button to leave the screen and return to the previously active patient.
The File screen sections can be adjusted be pressing the top edge of the file section on the touch
screen between header listings (name, ID, Accession, etc) to see more information for this
column.
To return the header section to the original size just press the same area again then move the
column back the original placement.
The lower SCROLL BAR will change to accommodate changes in the information screen area if
the columns get to large for a single screen. Pressing and moving the scroll bar will allow the
user/operator to view more information if needed.
Please see the individual sections below for more information on the functions of the buttons on
the file screen.
Fig 10.1
NOTE:
By default, the Facility Name is entered in the system by service and then is automatically
displayed until you request a change the information.
Column
Selects
Scroll
Bars
There are two ways to search for a patient file. The system can search for a patient by using the
SCROLL BAR on the right side of the patient list or by pressing the Patient Search button.
To search using the Patient Scroll buttons touch and then slide the shaded area inside the bar in
the center of the scroll bar to scroll through the patient files for the correct patient file.
To use the text entry boxes at the top of the screen press the Patient Search button, the system will
place a curser in the Last Name text entry search box located on the top edge of the patient file
screen.
The Operator may move the columns to allow viewing of additional data that may be too long for
a particular column by using the COLUMN SELECT points
The user will need to use the text entry keyboard to type in the last name.
To search by name press the text entry box “Last Name”, now type in the name you are looking
for into the test field. As the user enters the name the system will start to sort the patient records
Fig 10.3
WARNING:
Be sure you are deleting the correct patient record file. You cannot recover deleted
patient records or images!”
Button 4 At the prompt, press the Yes key. The system deletes all images and patient
information for the selected patient file or No to stop the delete operation and
return to the screen.
Fig 10.4
Fig 10.5
WARNING:
The system comes with a single permission to allow the doctor or other individual in
charge of the department to set up permissions for use of the device.
The owner operator is responsible for maintaining control of all medical records and if
the owner operator does not set permissions then control has not been established to limit
accesses to patient’s images, which are medical records
NOTE:
The user must understand that until the system is turned off or they log off the system.
Their name will be used to identify who copied images to external image storage
devices. User is encouraged to log off the system whenever they are finished storing to
external devices.
NOTE:
When exporting images to any outside media or devices (DICOM server, USB device,
and DVD/CD disk) the system creates an administrative log of the person who exported
using their Log in name and the date of the export. The export date is also placed on the
exported image as a means to identify when images were exported from the device.
The system will return to the main touch screen and the button will change
from Log In to Log Out.
The user should Log Out of the system whenever the system is left
unattended.
In all cases the system will not keep the Log In active if the power is turn
off. You must reenter your password after each power on cycle.
Fig 10.6
WARNING:
The user operator should use only medical grade CD and DVD disk as they have been
checked for flaws in the media and will be more successful in completing a store to the
disk.
Standard off the shelf CD and DVD disks may fail to write on occasion or may lose or
have defective media that will cause patient records to be lost when using these disks.
Some Media types may perform all the steps but fail to complete the TOC operations,
Make sure you check all disk in a PC to make sure data has been transferred before
deleting any images from the image system.
Ziehm Imaging, Inc. is not responsible for lose of patient information/data or poor
performance of the export function if common, non-medical grade DVD and CD disk are
used.
WARNING:
The ZIEHM QUANTUM is not to be used as a long term “Archiving Device”, its
primary use is in capturing and storing for limited time patient information and should
not be considered a mass storage or image server for patient data.
Ziehm Imaging, Inc. recommends the owner operator make backs of up all images for
patients using achievable media for long term image storage.
This could be Archival CD and DVD’s or by using Optional DICOM interface or by
using USB memory devices to transfer the images to a PAC’S image server or to other
computer systems having Archiving capabilities.
WARNING:
The Ziehm Imaging, Inc. recommends storing images to the USB device during the
procedure, transferring patient images after the procedure or transferring images at least
at the end of each day to prevent loss of these important medical records.
NOTE:
When exporting images to any outside media or devices (DICOM server, USB device,
and DVD/CD disk or video port, the system provides a date of export on image as a
means to identify when images were exported from the device.
The USB port will allow the user/operator to transfer images from the c-arm to another computer
in several image formats. (JPEG, TIFF, BMP for still images and AVI and DICOM media for
motion images (Cine/DSA).
You must first select the LOG IN button and log into the system to activate the USB memory
After the user logs into the system, they must insert a certified USB memory device in the USB
port and wait until the USB button is displayed on the Desk View touch screen.
During a procedure if the USB device is installed and active the user may store
images at any time during the procedure by pressing the USB store button.
This may be an effective way to reduce after case archiving time for the user
operator.
The limits of storage are set by the memory size of the device. Therefore, if you save an image in
BMP format 3.3 MB /image and you save 50 images you will need a memory device of at least
165 MB in size.
Most USB memory devices come in the following sizes of < 256MB, 512MB, 1GB or > 2 GB.
It is recommended that you use at least a 256MB memory device for storing still images.
For storing DSA and Cine runs memory capacities of > 1GB are recommended. DSA/Cine runs
are normally > 100 images per session and require large data memory capacity to store and
transfer these sequential image sequences.
Store time estimates: Store USB 3.3 MB of data = < 1.5 seconds
USB archive 200MB of data = approx. 2 min 20sec
This assumes all images were BMB file formats and a 2.0 USB device was used and images were
single frames not DSA or Cine sequences.
DSA/Cine runs take a little longer as the image format conversion must be performed before the
images are exported to the memory device.
Messages will be displayed to inform user of operation status during archiving processes. See
further details in this section for Archiving more than one patient and images at a time.
Play Button
Button 9 Allows the user to play back and stop the
play back of CINE/DSA image sequences
Button 10
Escape
The Escape button allows the user to leave
the Archive screen.
Button 11 If images were selected for any or all the
patients in the Archive list and the user
Escapes this screen the3 image marker will
be removed.
Patient Data:
The patient information for Archive
functions is located on the upper part of the
Archive screen. To select a patient for
Button 17
archive and to mark images for export just
touch the patient information line on the
screen. Wait a second to update the system
and display images.
WARNING:
The JPG and TIFF image formats will by nature have some loss of resolution and
dynamic range of the original image or compared to the higher lossless BMP image.
It is the Physician that should make the decision weather to use a particular image
format.
The BMP image is the most universal image format and can be read by almost all image
processing software packages. Windows Media player, Paint, Adobe Photo Shop, Corel Paint,
MS Word can import the image, as well as many other software programs.
BMP has one disadvantage in that it is large in size, approximately 3 MB of data.
The Archive screen allows the user to select one of the three image formats per-export session.
You cannot select multiple formats during a single export session for USB.
To select a new image format open the archive screen and press the
Image format required. The doctor/operator can choose to use any of
the three image formats.
The user/operator can select only one image format per recording session on the CD/DVD. This
means if you wish to save the images as JPG all the images saved for this particular burn to
CD/DVD must all be the same image format.
If the user wishes to save in different formats they will need to copy to USB memory stick or
CD/DVD with the selection of format changed for that particular burn cycle of the CD/DVD
As the user selects images the indicator will show an indicator bar. When using a DVD with less
If the USB memory device will be used, place the device into the USB port just
below the mobile stand keyboard. The user must wait for a few seconds for the
USB button to be displayed on the screen.
If the Optional DVD/CD device will be used, insert a disk into the disk drive
and wait for about 40 seconds for the disk to be recognized by the system. When
the system identifies the disk the system will display the DVD/CD button just
below the patient list.
If both are present at the same time the USB memory device and the DVD/CD
button will be displayed but the Capacity indicator will display the USB device
capacity not the DVD/CD device.
The user can now use the image scroll arrow keys to move the image selection
box to the image to be selected view the images on the right monitor.
Once the user has moved the selection box to an image they want to export they
can use the Mark-Img to mark a single image from the patient file or they can
use the Mark-All button to select the images to be exported.
Once the user has selected all the images for a particular export device, the user
must then press the device button USB or DVD to actual start the export of the
images to the external storage device. The button pressed will stay yellow
during the operation.
NOTE:
The USB is generally very fast taking only a few minutes to transfer images however,
the DVD can take as much as 30 min to greater than 1 hour to transfer several Giga
Bytes (GB) of data.
The DVD also needs to write a Table Of Contents (TOC) at the end of the image transfer
process. This unfortunately takes nearly the same time if you have just a few images
stored or many hundreds of images.
In both cases the system must obtain the image from the hard drive and then convert the
images from the RAW format into the particular image format selected and then add all
text and graphics to the image. This takes a few minutes depending on the number of
images selected.
WARNING:
If the user chooses to use non medical grade CD-R or DVD disks they do so at their own
risk.
The non medical grade DVD and CD disks have a potential to loose information or not
be recordable and may after a time not be readable.
“THESE NON MEDICAL GRADE DISKS ARE NOT RECOMMENDED FOR USE
BY ZIEHM IMAGING, INC.”.
NOTE:
The Embedded Windows operating system can in most cases determine the type and
model as well as find a driver to operate the USB memory device. However not all USB
memory device models and types can be accommodated Therefore, the ZIEHM
QUANTUM cannot use all USB memory devices.
NOTE:
In all cases with DICOM the system must have prior programming and settings made to
identify and provide correct addresses for the DICOM network server and printer.
CAUTION
The Administrator should use caution when performing the Erase Disk operation as this
operation will remove all the patient information from the system and cannot be retrieved
after it has been erased.
10.12.1 ERASING DISK AND ACTIVATING DATABASE AFTER ERASE DISK OPERATION
When using the ERASE DISK function the user must perform this in the following
manner to avoid errors in the database.
• Never perform this if the patient images have not been saved/removed from the
C-arm memory as they will be lost. Once the images are erased they cannot be
retrieved.
• Once all patient images have been exported and are safe the administrator should
ERASING DISK
• Press the ERASE DISK button and respond to the message box YES to erase the
Disk and NO to cancel the operation. After you press the YES button you will be
asked again a second time to make sure you wish to proceed with Disk Erase
operation.
• Once the disk operation has been completed, the user will be instructed to turn
off the c-arm and re-start the c-arm. After system is turned off Wait at least 10
seconds before turn on power again.
• After you turn on the power and the system has fully booted, press the hand
switch to start fluoroscopic exposure for 1 second, release hand switch and then
store the image by pressing the STORE button on the main touch screen. The
right monitor will display the image and small icon on the bottom.
ACTIVATING DATABASE
• Go to the configuration screen and perform the Erase Disk operation a second
time and then turn off power when directed to do so.
• Wait 10 seconds and then press the power on switch again. Wait until the system
is fully booted.
• Now press the NEW PATIENT button to establish a new patient in the image
system database. Recommend entering for patient name “TEST” and For ID
123.
• Now press the SAVE button to save patient file.
• Press the hand switch to start fluoroscopic exposure for 1 second, release hand
switch and then store the image by pressing the STORE button on the main
touch screen. The right monitor will display the image and small icon on the
bottom.
• System is now ready to enter additional patients and store images.
CAUTION
The Administrator should use caution when performing the Erase Disk operation as this
operation if not performed correctly may cause incorrect data base operations.
DICOM Settings
If the system has DICOM option and the administrator can
use his/her permission to allow the facility Information
Technologist (IT) access to change and configure the
DICOM settings for DICOM 1 and DICOM 2 to match
their DICOM port and AE TITLE information.
Please see example of settings for DICOM 1& 2 Screen Fig
10.9 and Fig 10.10.
NOTE:
McKesson: Removes (*) asterisk from DICOM (C-Find) worklist query. Allows
retrieval of work list, vendor specific solution for non-DICOM 3 complaint server.
All AE, IP, Port, Host names, Modality and Pacs Type are just examples in this manual the actual
values for each must be obtained from the Information Technologies department of the facility
and then entered accordingly.
To enter and set up DICOM services please contact your “Ziehm Imaging, Inc. Service
Representative” for details and to schedule the installation and testing of the DICOM
settings.
CAUTION
The log file should be copied once a week to keep it from getting too large. The system
will stop acquiring the log files when the file reaches it maximum capacity. There is no
alert for this so the Administrator is encouraged to copy and then reset the Log file once
a week.
The Log files can be found at the bottom of the Configure screen center and will only be visible if
the Administrator has logged into the system. See example of the configuration screen above in
this section of the manual.
User configurations
The Administrator and the User may select the start up default settings for several of the image
operations, such as, set the NR to start at low, med, or high. Select invert, image mirror
operations, Last image Noise reduction “LIH”, etc.
See Configuration screen below for selections and location of the buttons.
VERSION:
Press the lower right button VERSION on the configuration
screen and a message box will open with the current software
versions. Press “OK” to clear the screen; you may have to do
this twice
SAVE
The User and Administrator must press the SAVE button to
save any changes to the configuration screen before leaving
otherwise the changes will not take effect when the system is
rebooted.
ESCAPE
The user can escape the screen without changes by pressing
the ESCAPE button. The system will close the configuration
screen and then return to the Patient File screen.
• Press the selection buttons to toggle the
functions ON or OFF, or to set a mode like
noise LOW, MED, or High.
• The sections are used at startup and are the
default settings when the system boots.
• After you make changes press the save
button to save the changes.
NOTE:
Some selections will have no effect if the owner operator did not purchase certain
product options. Such as CINE, DSA, DICOM, etc.
• Ensure that the C-Arm base plate and generator cradle bracket are securely mounted
to the floor. Example Fig 11.1
Figure 11.1
• Power up the C-Arm and adjust the vertical height to 14cm. Example Fig 11.2
Figure 11.2
• Slowly but firmly push the front C-Arm wheels up the base plate ramp while
guiding the generator assembly to the generator cradle bracket Example Fig 11.3.
Figure 11.3
• Adjust the steering lever to position the steering wheels at 90 degrees to the C-Arm body.
Example Fig 11.4.
• Lower the vertical shaft while guiding the generator assembly into the generator cradle.
Continue until the vertical shaft is at 0cm. Example Fig 11.5
• Position the bracket with stencil # 4 over the left wheel hub assembly. Example Fig
11.6
• Position the bracket with stencil #3 over the right wheel hub assembly. Example Fig
11.7
• Position the bracket with stencil #2 over the front wheel assembly. Example Fig
11.8
• Tighten the 2 bolts to secure the front wheel bracket to the floor mounting plate and
the 3 bolts to secure the left and right wheel brackets to the floor mounting plate.
Example Fig 11.9
• Push the shipping lock forward and while simultaneously pulling the curved portion
of the bracket around the DeskView support shaft. Example Fig, 11.10.
• Tighten the locking bolt to secure the shipping lock. Example Fig 11.11
• Press the DeskView assembly into the home position and lift the lever to securely
locate the DeskView to the transport position. Tighten the two bolts to keep the
lever in position. Example Fig 11.12
• Ensure the C-Arm monitor arm assembly is fully extended after securing the
DeskView shipping locks. Example Fig 13
• Slip the Arm Support Shipping lock onto the horizontal arm assembly. Example Fig
11.14
• Flip up the lever and partially tighten into position. Example Fig 11.15
• Slowly rotate the monitor arm into the top portion of the Arm Support Shipping
lock. Example Fig 11.16
• Flip up the lever and secure into position and tighten bolt from step 7 above.
Example Fig 11.17
• For removal instructions perform the above steps in reverse order starting with the
shipping locks and then the floor brackets.
• Remove monitor assembly from the c-arm monitor arm and insert the monitor assembly
into the transport container. (see section 4.2.2 for how to mount and un mount the
monitor assembly)
• Make sure the monitor seat fully into the transport container
• Close the Container and lock the locks on the front side of the container then strap the
container to the shipping floor, truck, or pallet
WARNING:
The ZIEHM QUANTUM is not suitable for use in a flammable atmosphere.
WARNING:
Rapid changes to temperature can damage system components. DO NOT operate system
until equipment has reached a safe operating room temperature. Severe damage may
occur! Failure to observe this warning will result in loss of warranty and sever damage
to the device. Several hours may be required for system to reach safe temperatures.
NOTE:
Environmental limits for system.
Transport: -100 –600C, Humidity 10% - 95% non condensing, Pressure: 500 – 1060mbar
Operational: +10 – 350C Humidity 35% - 75% non condensing
12.3 X-RAY GENERATOR X-RAY GENERATOR, HOUSING AND TUBE WITH BEAM-
LIMITING DEVICE
Device: ZIEHM QUANTUM C-Arm with x-ray source assembly Maxipuls 3-110 Generator
12.4 MECHANICS
X-Ray Tube Focal Spot and Reference Axis 30” C-profile opening
Fig 12.2
MM Inches MM Inches
220 9.00 822 19.30
252 9.94 910 35.75
340 13.375 940 37.00
399 15.70 950 37.40
430 17.00 970 38.25
450 17.75 1669 66.90
490 19.30 1710 67.25
510 20.00 1840 72.50
680 26.75 2080 81.875
700 27.50 2140 84.25
760 30.00 2300 90.50
800 31.50
F i g 1 2 . 3 : R a d i a ti o n S c a t t e r P a t t e r n
Distribution of scattered radiation in the significant zone of occupancy of the C-arm stand.
Measurement conditions in accordance with EN 60601-1-3:1994
Exposure conditions: 84 kV / 3.90 mA / 327 W
Rectangular water phantom 25 cm × 25 cm × 15 cm + 1.5 mm Cu Distance phantom/image intensifier: 50
cm
Measuring instrument: Radcal 1515 S/N 15-1 427
Height above floor in cm
12.8.1. Calibration of calculated dose measurement 21CFR 1020.33 (k) (4) (ii)
The Equipment Owner is responsible for ensuring that only persons who are trained and qualified
are allowed to service and make adjustments.
The Equipment Owner is responsible for ensuring that the x-ray system complies with the
applicable sections of CFR 21 1020.30 (h) (6) (i), Compliance must be periodically verified by
subjecting the system to various test procedures defined by the Center for Disease and
Radiological Health (CDRH) including the calculated dose measurement system
If the system fails to operate correctly, or fails to respond to system controls as outlined in this
manual, notify the local, authorized Ziehm Imaging, Inc. dealer representative.
Only authorized personnel are allowed to assemble and/or repair the medical equipment described
in this manual. Authorized personnel are persons who have attended an appropriate training
course provided by the manufacturer.
Calibration of the generator or the dose measurement system shall only be performed by trained
and authorized personnel. Calibration procedures are part of the technical documentation and are
not outlined in this manual.
decimal point according to the dose rate and the accumulative values depending on weather
radiation is on or off. This also includes the dose for all images which have not been saved but are
part of the radiation accumulated since the last reset of the Dose/Timer display.
12.8.3. TEST INTERVAL:
In accordance with FDA 21 CFR 1020.30(h)(6)(i), a schedule of maintenance for any system
instrumentation associated with the display of air Kerma information necessary to maintain the
displays of AKR and cumulative air Kerma. Therefore, the automatic dose rate must be tested at
regular intervals. Every month is recommended, however owner/operator must comply with local
and national standards that may apply.
The AKR Dose Display must be tested twice yearly by a qualified and authorized Service
Representative to insure the dose display accuracy and perform Calibration if required.
12.8.4. OPERATOR MONTHLY TEST PROCEDURE:
• Turn on the C-arm and wait for the system to become fully operational
• Select Fluoroscopy program (Extremities)
• Insert a patient-equivalent phantom (2.5 cm x 15 cm square aluminum plus 1.5 mm copper)
or equivalent in the beam at approximately 30 cm from the image intensifier on top of a
radiation translucent table.
• Position the c-arm image intensifier over the phantom with generator under the table making
sure the phantom it is in the middle of the radiation beam.
CAUTION
Observe all radiation safety procedures during the text test steps.
• Perform radiation by pressing the hand switch and holding it for at least 20 seconds.
• Observe the control panel display values. They should resemble the following. (Actual
values may be slightly different) 70 + 2 kV / 5.7 mA + 0.4 mA Dose display will be in
mGy/min.
• Write down the value of kV/mA and dose mGy/min in your log.
• Press and hold the Reset Timer button for 2 seconds to reset the fluoroscopic timer and the
dose display on the touch panel.
• Press and hold down the radiation hand or foot switch to initiate radiation. The test takes 1
min. Do not interrupt the test. During the test, the system calculates and displays the dose
rate in mGy/min. Release hand switch when fluoroscopic timer reaches 1 minute “stop the
radiation as fast as possible”
• View and record the cumulated dose rate displayed from the touch panel
• Compare the new data with the previous monthly data test record.
NOTE:
If this is the first time you are doing this test then just record the information in your log
as the reference value then compare the next months test to this value
NOTE:
Calibration instruction can be found in the product technical manuals as Work
Instructions and should only be performed by authorized Ziehm Imaging, Inc. services
or a trained dealer representative.
Dose Air Kerma Setup Diagram 21CFR 1020.33 (k), (4), (ii)
Fig 12-4: AKR Dose Calibration Setup
Fig. 12.6
W atts
3.5 3.5
mA
3.0 3.0
2.5 2.5
2.0 2.0
1.5 1.5
mA
1 1
Watt
.5 .5
0 0
40 45 50 55 60 65 70 75 80 85 90 95 100 105 110
KV
NOTE:
A detailed maintenance schedule can be found in the “ZIEHM QUANTUM Technical
Manual”. Technical information necessary to repair or upgrade the ZIEHM
QUANTUM system will be made available by Ziehm Imaging, Inc. to authorized and
qualified personnel upon request.
NOTE:
The relevant radiation protection regulations of a country, local state, or regional
authority at time of installation must be observed.
Maximum radiation When the iris collimator is completely open, the edges of the collimator blades
field size must be just visible on the monitor.
WARNING
Contact your after-sales service authorized Ziehm Imaging, Inc. dealer representative
center in case of any non-conforming issues.
• display functions
• line cord condition; ground
• cables condition
• mechanical movements and limits
• laser power supply voltage tests (as applicable)
• laser alignment (as applicable)
14.2 CLEANING
14.2.1. RECOMMENDED DETERGENTS
For cleaning the system, use only water with mild detergents applied with a damp cloth. Never
use abrasive cleansing agents, organic solvents or detergents which contain solvents (e.g. alcohol,
petroleum ether, liquid stain remover).
WARNING
Take care that no liquids penetrate into the unit through sockets, plugs, ventilation holes
or gaps (at integrated external devices such as video printers or video cassette recorders).
Never apply spray cleaners directly onto the unit!
13a
7
14
15
14
16
28
17a
34/35*
32/33*
26 40 30/31* 8
27
20 10
21* XPO
25
36 24
22/23 6
13b
2/3*
4/5*
1
41
Label with the * next to the number are only required if the system ships to Canada
17b
16
15
15 14
42
Label with the * next to the number are only required if the system ships to Canada
6 FOCAL SPOT:
TUBE HOUSING:
0.5 / 1.5mm
MAXIPULS 3-110
1
TUBE INSERT TYPE: DF-151-R-0.5/1.5-110-40
TUBE SR. No.: 912 / XXXXXX
Registration No. OC8510253-02
MANUFACTURED BY:
ZIEHM IMAGING GmbH
DONAUSTRASSE 31, D-90451, NUREMBURG
MANUFACTURED: MONTH: __________ YEAR: ______
SERIAL No.
Located on the image receptor just
under the mounting bracket for the
TH 9429 HP2-H552
7 Image Intensifier
C-Profile. 1
COMPLIES WITH CDRH RADIATION PERFORMANCE
STANDARDS, 21 CFR SUBCHAPTER J. AS OF DATE
OF MANUFACTURE
MANUFACTURED BY:
ZIEHM IMAGING GmbH
DONAUSTRASSE 31, D-90451, NUREMBURG
MANUFACTURED: MONTH: ____________ YEAR: ______
Radiation Warning
Located on Generator
8 1
Background is Yellow in color
Top Desk
Located on top of the Mobile stand
KEEP
9 OUT 1
RADIATION
CONTROLLED AREA
WITHIN 4M DISTANCE
LASER 2
17a Qty 2 for Laser LC (depending
APERTURE on options)
Background is Yellow in color
18 Reserved Reserved
19 Reserved Reserved
Equipment bonding
22 1
27 Reserved Reserved
28 Monitor Arm
Assembly 1
MANUFACTURED BY:
ZIEHM IMAGING, INC.
3468 WEBSTER AVENUE, PERRIS, CA 92571
MANUFACTURED BY:
ZIEHM IMAGING, INC.
3468 WEBSTER AVENUE, PERRIS, CA 92571
32 1
39 2
UL Label
42 2
WARNING
Please contact your after-sales service center also if a certain error occurs frequently!
17.0 GLOSSARY
TERM DEFINITION
A piece of hardware used for a special function such as Radiographic
Accessory
Cassette holder
Activate To make a function or mode operational/active
The patient file that is open and allowing capture and storing of new
Active Patient
images
Adipose Fatty tissue, Adipose patient large patient
Air Kerma Air kerma is a measurement of radiation dose
Anatomical Refers to human anatomy
Auto Function a function that is automatically controls a function or mode
Brightness is an attribute adjustment that allows visual perception in
Brightness
which the monitor source appears to emit a given amount of light
A mechanical or electrical device that actives a function or mode of
Button
operation
C-Arm A medical device that has a C shape and provides Fluoroscopic imaging
CFR Code Of Federal Regulations
Cine A sequential acquisition of images
Clockwise To move or rotate something in the direction of clock movement.
Collimator A device which collimates the radiation beam size
A button that allows the operator to remove from memory images or
DELETE
patient data
A touch control screen which allows the user to control the system
DeskView
functionality and modes of operation.
Digital Imaging and Communications in Medicine (DICOM) is a
DICOM standard for handling, storing, printing, and transmitting information in
medical imaging
Digital Image
The electronic rotation of a displayed image.
Rotation
Digital A type of Fluoroscopy technique used in interventional radiology to
Subtraction clearly visualize blood vessels in a bony or dense soft tissue environment.
Angiography Images are produced
Diode Laser
A small electronic devices that emits laser light
Modules
Display See display
Display A device that presents images or data to the operator
Dose Amount of radiation
DSA image Image created during Digital Subtracted Angiography
DVD Digital Video Disk
Dynamic Image
A capture of sequential images to memory
Acquisition
Emit Laser
Laser light projected from a laser device
Radiation
Enter button to accept a change
ESC button ESCAPE
Export Function To method to export images to external storage devices
Exposure Time The time radiation is active or the length of a single exposure
TERM DEFINITION
Federal Drug Administration a US government entity that is charged with
FDA
regulating medical devices in the US
Fluoroscopy is an imaging technique commonly used by physicians to
Fluoroscopy obtain real-time images of the internal structures of a patient through the
use of a fluoroscope
Foot Switch A device that allows the user to press with their foot to activate radiation
Frame Rate
Sets the rate of image capture for Cine or DSA image capture.
Button
Function Function is a method, procedure, which performs a specific task
The device that houses the X-Ray tube, high voltage and mA control
Generator
circuits that produce radiation
Hand Switch A hand held object that allows the operator to activate radiation.
Hold I.e. hold the button
ID Identification
International Electrotechnical Commission - An international standards
IEC
organization dealing with electrical, electronic and related technologies
A function of the image system that acquires the image to be stored or
Image Acquisition
displayed on the monitors
Image Mirror To flip the image head to foot or left to right
INV Same as invert
A button that allows the operator to invert whit to black and black to
Invert
white in the video image.
A device that collimates radiation in to a circular beam and allows
Iris collimator
operator to limit radiation beam size to reduce exposure to the patient.
Killio Voltage, high voltage used to create radiation within the generator
kV
housing
A laser is an electronic-optical device that emits coherent light radiation.
Laser It is sued as advice on the c-arm to center the patient anatomy before
radiation is activated.
LIH Last Image Hold
Displays the real time image as well as recalled images that have been
Live Monitor
transferred from the reference monitor
Large Patient Diameter button allows the operator to visualize larger
LPD
patient without increase in radiation dose
Ma Milliampers
Mag button that allows user to magnify the image
magnification The electronic magnification performed by an image intensifier
Manual Exposure A method to adjust the radiation dose by manual adjustment of the
Rate Setting kV/mA
Medical Devices that are designed and built for the purpose of use in medical
Equipment procedures
Refers to specific requirement for devices or components that can be used
Medical Grade
in conjunction with medical devices
Memory Device A device that stores electronic data
Metal Artifact Allows the user to set a new black level in the image to correct the image
Correction as result of much metal in the radiation beam
mGy MiliGrays a measurement of dose
Min Minute
TERM DEFINITION
Mobile Stand The C-arm assembly as a whole
Distinct method of operation within a computer program, in which the
Mode same user input can produce different results depending of the selection
of functional attributes
Monitor A device that converts electronic signals into a visible image
A function that reduces quantum noise in the image during live
Noise Reduction
fluoroscopic imaging
Nominal Image
the normal or standard image size.
Diameter
A specified set of image criteria used to provide better imaging in a body
Organ Program
region
PAC’S
Patient Dose The amount of radiation dose received by a patient
A device that coverts one or more in coming voltage levels to another
power supply
voltage level(s)
press i.e. press the button
pulse fluoroscopy A short burst of radiation in succession
radiate to expose a person or object to radiation
Ionizing radiation, is a form of electromagnetic radiation which is used
radiation
to view internal structures.
Radiation
A electromechanically lamp or video display ICON that is visible and
Exposure
may changes color to alert user that X-rays / radiation is active/on
Indicator
Range a range of operation; the difference between the highest and lowest value.
Real-Time Edge A function that provide electronic enhancement of edge detail in the
Enhancement image during live Fluoroscopic exposures
Image that is recovered from the image system memory and is displayed
Recall Image
on the reference monitor
Receptor a device that is in line with the radiation beam
Reference Monitor The monitor that displays the recalled images and Thumbnails
Reset Timer button that causes the radiation timer to go back to zero
Rotate refers to a movement of an object in a circular motion. The C-
Rotate
profile rotates to allow positioning of the device
As set of written Instruction in the user manual or labeling that warns
Safety Instructions
operator /user of possible harm if instructions are not followed
Save button that causes the image system to store an image to memory
To read or view extended text or images that is part of an electronic file
Scroll
that could be out of view in a text or electronic file window
function button allowing the operator to view in succession stored images
Scroll Arrow Keys
of the image system
A Qualified and trained person that can make adjustments and repairs to
Service Engineer
the c-arm
A device located in the Generator housing assembly that collimates the
Slot Collimator
radiation filed on two sides to limit the radiation beam
A mode or function of the C-arm where in the C-arm makes radiation for
Snapshot Mode a specific length of time and for which noise reduction is automatically
set and the image is captured and displayed
Allow the operator to steer the C-arm stand during transport or when
Steer
position during use
TERM DEFINITION
Store button, i.e. store an image
verb, i.e. Mechanical or electrical button, lever, that activates a
Switch
functional operation
Mechanical or electrical button, lever, that activates a functional
Switch
operation
Settings which can be changed to modify the operation of the image
System
system as defaults to functions such as, noise reduction, frame rate,
Configuration
Image Invert
USB flash drives, and flash memory data storage device integrated with a
USB (universal serial bus) connector. USB flash drives are typically
Thumb Drive
removable and rewritable and are used to externally store images from
the c-arm
Reduced-size versions of pictures, used to make it easier to scan and
Thumbnail recognize them, serving the same role for stored images as a normal text
index does for words
Electromechanically device which is used as the Graphical User Interface
Touch Screen
for controlling the c-arm functionality. Also known as "DESK VIEW"
Transfer Button, i.e. transfer image form left to right or right to left monitor
The current that is flowing in the X-ray tube between the Anode and
Tube Current
cathode and is rated in milliampers "mA"
the voltage applied across the X-Ray tube insert. Rated in Killio Volts
Tube voltage
"kV"
Noun, i.e. Universal Serial Bus is a serial bus standard to interface
USB
memory storage devices
Value Noun, i.e. value remains stored and displayed
Vertical Lift Noun, the c-arm mobile stand vertical support arm assembly motor drive.
Noun, i.e. the distance between two waves of energy, or the length of the
Wavelength
light wave used by image intensifier and Cameras sensor
Noun, i.e. a type of radiation that can go through many solid substances,
X-Ray allowing hidden objects such as bones and organs in the body to be
photographed
Ziehm Imaging,
Medical Manufacturer of Ziehm Quantum
Inc.
ZIEHM
Medical Device Product Name
QUANTUM
Zoom Magnification of a captured image by means of digital imaging
End of Manual