Zenith-C20, Zenith-C11, Zenith-C22

CONTRAST MEDIA INJECTOR

USER’S MANUAL
This manual should be read carefully before installing and operating the system. It is
recommended to keep this manual well for further reference.

© Seacrown Electromechanical Co., Ltd.

Reversion History
Initiated on 01/29/14

Project Technical
Version Date Description
Manager Writer
A/1 05/04/2015 Updated description error. Shawn Chung Wubing Xia

Updated the new console screen Shawn Chung Wubing Xia

B/0 13/01/2016
description.
Corrected error codes and part Shawn Chung Wubing Xia
C/0 01/11/2016
numbers
C/1 10/05/2018 Update the new logo and file No. Shawn Chung Wubing Xia

Added optional part descriptions, Shawn Chung Wubing Xia

C/2 28/11/2018 warrant terms and corrected print
errors.
Added the [S] button function Shawn Chung Wubing Xia
C/3 14/12/2018
instruction.
FOREWORD

The Zenith CT contrast media injector is a syringe-based fluid delivery system indicated for
delivery of contrast media during computed tomography (CT) procedures, and is intended to
be used by licensed medical practitioners for the specific purpose of injecting intravenous
contrast medium into the human vascular system for computed tomography studies. This
device is designed to correspond to the various injection methods of contrast media that were
established with the use of multi-slice CT scanners.

This manual applies to the systems in the following models: Zenith-C20, Zenith-C11 and
Zenith C22. Model Zenith-C20 is single syringe system. Model Zenith-C11/C22 (i.e.
Zenith-C11 or Zenith- C22) is two syringe system.

Misuse or abuse may occur unintentionally because the user does not know proper
method of operating the system. Read this manual carefully before installing and
operating the system and keep it well for future reference.

You can call SEACROWN for any service requirement when you need.

SEACROWN TECHNICAL SUPPORT

Phone No. +86 755 26060959

This copy of PT-010-202 Rev. C/3 is valid as of December 14, 2018 .

The signed original is maintained in Documentation Systems.
You should confirm this copy’s reversion is the latest released before use it.

CAUTION: Federal law (US) restricts this device to sale by or on the order of a physician.

Shenzhen Seacrown Electromechanical Co., Ltd

Address 4th Floor, 2nd Building, Rongcun Industrial Park, Shekou, Nanshan Zone,
Shenzhen,Guangdong, China , 518067

MedNet GmbH
Address Borkstrasse10, 48163 Münster, Germany
 Table of Contents

1 BASIC INTRODUCTION ......................................................................................................... 1-1

1.1 Product Identification ........................................................................................................ 1-1

1.2 Indications for use .............................................................................................................. 1-1
1.3 Contraindications ............................................................................................................... 1-1
1.4 User Qualification .............................................................................................................. 1-1
1.5 Symbols ............................................................................................................................... 1-2
1.6 Warnings, Cautions and Important Notice ...................................................................... 1-5
1.7 Features .............................................................................................................................. 1-9
1.8 System Response to Occlusions ......................................................................................... 1-9
1.9 Over and Under Injection Protection .................................................................................. 1-9
1.10 Maximum Flow Rate .......................................................................................................... 1-9
1.11 Disposables ....................................................................................................................... 1-10
1.12 Warrant Terms ................................................................................................................. 1-11

2 SYSTEM OVERVIEW ............................................................................................................... 2-1

2.1 Zenith-C11/C22................................................................................................................... 2-2

2.2 Zenith-C20 .......................................................................................................................... 2-4
2.3 Specifications ...................................................................................................................... 2-6
2.3.1 Dimensions and Weights................................................................................................ 2-6
2.3.2 Environmental Requirements ....................................................................................... 2-9
2.3.3 Electrical Requirements ................................................................................................. 2-9
2.3.4 Fluid Delivery Performance ........................................................................................... 2-9
2.4 Injector Arm ...................................................................................................................... 2-10
2.4.1 Moving Piston Rod ........................................................................................................ 2-13
2.4.2 Getting System Ready on Arm .................................................................................... 2-14
2.4.3 Test Injection ................................................................................................................ 2-14
2.4.4 Controlling Injection..................................................................................................... 2-14
2.4.5 Volume Display ............................................................................................................. 2-14
2.4.6 System Status ............................................................................................................... 2-14
2.5 Console .............................................................................................................................. 2-16
2.5.1 Console Buttons ............................................................................................................ 2-16
2.5.2 Console Display Screens .............................................................................................. 2-17
2.5.3 Home Screen ................................................................................................................. 2-18
2.5.4 Protocol Screen.............................................................................................................. 2-24
2.5.5 System Setup and Test Screens................................................................................... 2-28
2.5.6 History Screen............................................................................................................... 2-38
2.5.7 Help Screen ................................................................................................................... 2-39
2.6 Main Controller ................................................................................................................ 2-40

3 POWER ON/OFF ....................................................................................................................... 3-1

3.1 Turning the System Power On .......................................................................................... 3-1

3.2 Turning the System Power Off .......................................................................................... 3-2

4 READYING SEQUENCE ......................................................................................................... 4-1

User’s Manual i
 4.1 Deciding on Injection Protocol ........................................................................................... 4-2
4.1.1 Programming Protocol .................................................................................................... 4-2
4.1.2 Recalling Protocol ........................................................................................................... 4-3
4.2 Installing Syringe ............................................................................................................... 4-4
4.3 Filling Syringe .................................................................................................................... 4-5
4.3.1 Filling Syringe Manually ............................................................................................... 4-6
4.3.2 Filling Syringe Automatically........................................................................................ 4-6
4.4 Attaching Tubing to Syringes............................................................................................ 4-7
4.5 Purging Air from Syringe .................................................................................................. 4-8
4.6 Priming Tubing................................................................................................................... 4-9
4.6.1 Priming Tubing with Saline........................................................................................... 4-9
4.6.2 Priming Tubing with Contrast ...................................................................................... 4-9
4.7 Connecting to Patient ........................................................................................................ 4-9
4.8 Getting System Ready on Console .................................................................................. 4-10

5 PERFORMING INJECTION .................................................................................................... 5-1

5.1 Reviewing Parameters ....................................................................................................... 5-2

5.2 Test Injection ...................................................................................................................... 5-3
5.3 Running KVO Injection ..................................................................................................... 5-4
5.4 Bolus Tracking Injection .................................................................................................... 5-5
5.5 Protocol Injection ................................................................................................................ 5-7
5.5.1 Starting Protocol Injection ............................................................................................. 5-8
5.5.2 Pausing an Injection ....................................................................................................... 5-9
5.5.3 Restarting an Injection................................................................................................. 5-10
5.5.4 Terminating an Injecting ............................................................................................. 5-10
5.6 Removing Syringe ............................................................................................................ 5-11

6 INSTALLATION........................................................................................................................ 6-1

6.1 Assembling Parts................................................................................................................ 6-1

6.1.1 Assembling Parts of Zenith-C11/C22 ............................................................................ 6-1
6.1.2 Assembling Parts for Zenith-C10 .................................................................................. 6-6
6.2 Locating Parts .................................................................................................................... 6-8
6.2.1 Locating Parts of Zenith-C11/C22 ................................................................................. 6-8
6.2.2 Locating Parts of Zenith-C20 ......................................................................................... 6-9
6.3 Connecting External Cables ............................................................................................ 6-10
6.3.1 Connecting Zenith-C11/C22 External Cables............................................................. 6-10
6.3.2 Connecting Zenith-C20 External Cables .................................................................... 6-12

7 MAINTENANCE ....................................................................................................................... 7-1

7.1 Routine Maintenance ......................................................................................................... 7-1

7.2 Monthly Inspection............................................................................................................. 7-1
7.3 Annual Maintenance .......................................................................................................... 7-2
7.4 Cleaning .............................................................................................................................. 7-2
7.4.1 Cleaning Injector Arm .................................................................................................... 7-2
7.4.2 Cleaning Console ............................................................................................................ 7-3
7.4.3 Cleaning Main Controller .............................................................................................. 7-3

ii User’s Manual
8 MESSAGES................................................................................................................................ 8-1

8.1 Injector Ready Messages.................................................................................................... 8-1

8.2 Injection Messages ............................................................................................................. 8-2
8.3 Protocol Messages .............................................................................................................. 8-3

9 EMC INFORMATION ............................................................................................................... 9-1

10 INDEX ...................................................................................................................................... 10-1

User’s Manual iii

1 Basic Introduction
1.1 Product Identification
Protection against electric shock
According to IEC60601-1, the system is designed as a ClassⅠ Medical Device with a type
BF applied part.
Degree of protection against ingress of water
The system is classified Ordinary Equipment.
Electromagnetic compatibility
The system meets the radiated emissions (Class A) and immunity standard IEC 60601-1-2
for medical devices.
Mode of Operation
According to EN60601-1 the mode of operation for the main controller and console is
continuous operation. They are capable of operation under normal load for an unlimited
period, without excessive temperature being developed.
The mode of operation for the injector arm is continuous operation with intermittent
loading. Although power is applied to the injector arm continuously, the intermittent use of
loading and injecting will result in an internal temperature less than the continuous load
operating temperatures, but greater than the no load operating temperatures. Under normal
operating conditions with a minimum of 10 minutes between injections, the internal
temperature of the injector arm will not raise enough to degrade safety, system performance
or reliability.

1.2 Indications for use

The system is intended for the specific purpose of injecting intravenous contrast media or
saline into humans for diagnostic studies in computed tomography (CT) applications.
All kinds of iodinated contrast media and saline can be delivered by the system.

1.3 Contraindications
The system is not to be used for drug infusion, chemotherapy, or any other use for which
the device are not indicated. The system is not intended for portable use.

1.4 User Qualification

The system should be operated ONLY by qualified personnel who:
•are completely familiar with the unit, have read and understood this User’s Manual,
•are otherwise properly trained in the use of equipment and procedures of this type.

User’s Manual 1-1

1.5 Symbols
The following symbols are used on the system and throughout this manual.

Warning statements describe conditions or actions that

can result in personal injury or loss of life..

Caution statements describe conditions or actions than can

result in damage to the equipment or loss of data.

Indicates that the information that follows is additional

important information or a tip that will help you recover from an
error or point you to related information within the manual.

Indicates that this system conforms to requirements of the

European Medical Device Directive 93/42/EEC.

Identifies a type BF applied part complying with EN 60601-1

standards.
Manufacture address

European Representative

Serial Number

Keep Dry

This way up

Fragile

Do not roll

User’s manual

Safety ground

Previous Page

Next Page

Class I Indicates the system is Class I medical equipment as defined by

EN 60601-1 standards.

1-2 User’s Manual

User’s Manual 1-3
 Expel Air

Autofill

Forward

Test

Ready

Stop

Inject

LCD Power Button

[S] Save Button

[I] Inject Button

1-4 User’s Manual

1.6 Warnings, Cautions and Important Notice

IMPROPER USE WITH THE SYSTEM COULD RESULT IN

SERIOUS INJURY TO THE PATIENT OR THE USER.
The system should be operated only by qualified personnel who
have read and understood this manual or are properly trained in
the use of this equipment.

AIR EMBOLISM COULD CAUSE PATIENT INJURY OR DEATH!

Always verify all air in the fluid path have been expelled before
connecting the system to the patient. Carefully read the
instructions for loading to reduce the chance of air embolism.
The system is not able to check for air in the syringe and tubing.
The user is responsible for removing all air from the system.
To minimize air embolization risks, ensure that one user is
designated to complete all injection procedures. If the user must to
be changed, ensure that the new user verifies that no air in the
fluid path.

ELECTRIC SHOCK HAZARD!

Serious electric shock injury will be caused by contact with the
internal systems. Only professional personnel should open the
system case.
If any worn or damaged cables are detected, do not use the system.
Call SEACROWN for assistance.

THE OCCURRENCE OF CROSS-CONTAMINATION AND

INFECTION WILL CAUSE SERIOUS HARM TO THE PATIENT!
Using aseptic technique, install syringe, connect tube and connect
to patient.
Syringes may not be used to store contrast media for long periods
of time. The syringe with contrast media in it should be
immediately used.
Do not remove the plunger to fill the syringe.
Disposables whose packaging has been opened or damaged may
not be used.
All disposables are intended for single patient use only. Do not
reuse any disposables.

NON-COMPLIANT DISPOSABLES COULD RESULT IN PATIENT

INJURY, OPERTOR INJURY AND/OR QUIPMENT DAMAGE.
The system has been approved for use with only the consumables
listed in section 1.8 Disposables.
Patient injury could result if the syringe is not properly engaged.
Ensure the syringe is properly snapped into the front of the
injector arm before injecting. Improper engagement may cause the
syringe to leak, become damaged, or to come off during the
injection and result in an under-volume delivery.

User’s Manual 1-5

 PATIENT INJURY MAY RESULT FROM A SYSTEM
MALFUNCTION.
If a system malfunction occurs, immediately remove and
disconnect the system from the patient. If a fault message is
displayed that cannot be corrected, and/or the system is not
operating correctly, do not use the system.

EXPLOSION HAZARD!
Patient injury could result from explosion caused by using the
system in the presence of flammables. Do not use the system when
flammables are present.

FIRE HAZARD!
Patient injury could result from a fire caused by using incorrect
fuses. To avoid an electrical fire assure the same type of fuse as
original is used for replacement.
Only use the power cord supplied with the system. Do not plug the
power cord into an extension cord or multi-outlet power strip.

MATERIAL TOXICITY HAZARD!

Patient injury could result from potentially hazardous system
electronic assembly material. Dispose of system components or
accessories properly. Follow local regulations for proper disposal
or contact SEACROWN Service for assistance.

IMPROPER MEDICAL FLUID VOLUME AND FLOW RATE MAY

HARM PATIENTS.
Configure the injection contrast media volume and flow rate
according to the patient's weight and physical condition.
Fill syringes only with the minimum amount of contrast required
by the procedure to be performed on the patient.
Prior to commencing the injection, review all parameters
thoroughly to ensure that they are correct and appropriate for the
procedure.

The system must only be connected to a supply main with

protective earth.

Failure to use the hand switch could result in Electro Magnetic

Emissions not meeting specification.

The system are not serviced or maintained while in use with the
patient.

In order to ensure the system's leakage current and voltage is

normal, only the equipment which complies with IEC/EN60601-1
( or IEC/EN60950-1) can be connected to our system.

Do not to position the system to make it difficult to operate the

disconnection device.

1-6 User’s Manual

 If the contrast media permeates into the injector arm or accumulates on
the piston rod, short circuits can occur or the movement of the piston rod
may be inhibited. Both could cause damage to the system. Be absolutely
sure to promptly clear away residual contrast media. Place the injector arm
in a downward-facing position of the syringe to prevent contrast media and
other medicinal liquids accessing the injector arm.

In the event of water vapour condensation, connecting the power may

damage the system's electronic components. System taken indoors from
outdoor environments of extreme temperatures should not be immediately
used. Only use the system once there is no more water vapour
condensation indoors.

Incorrect voltage can cause system damage. Check that the power source
voltage and frequency are identical to those marked on the system label on
the injector arm.

When calibrating the touch-screen, do not use sharp objects to make

contact with the touch-screen.

Failing to carry out routine maintenance may cause system malfunctions.

It is recommended that regular maintenance be carried out to ensure the
system remains in a well calibrated operational state. For details, please
review the manual or contact SEACROWN for more information.

Do not use strong chemicals such as acetone to clean the system. Warm
water and mild disinfectants are sufficient.

To avoid damage to the touch-screen, do not directly spray cleaning liquid

onto the touch-screen. Wipe it using a non-abrasive cloth or paper towel
that has been dipped in soluble cleaning liquid.

Improper or careless cleaning methods may result in equipment damage.

Do not soak or immerse any part of the system in water. While cleaning
any outside portion of the system, avoid allowing any water to leak inside
system components.

Component damage may occur if not installed properly. Ensure all

connections are secure; do not over tighten. This will help minimize leaks,
disconnection, and component damage.

In circumstances where strong electromagnetic fields generated by

wireless electrical transmitters or strong static electricity discharges are
present, the system may be unable to operate normally.

User’s Manual 1-7

 The use of disposables not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of
the resulting system. Consideration relating to the choice shall include
evidence that the safety certification of the disposables has been
performed in accordance to the appropriate EN 60601-1 and/or EN
60601-1-1 harmonized national standard.

If any anomalies in the system performance are noticed, identify devices

within the immediate area that are capable of producing
electromagnetic interference and call a qualified service representative.

Above or additional warnings, cautions and notes are located throughout this manual, where
applicable.

1-8 User’s Manual

1.7 Features
The basic features of the system include:
•Store and recall of protocols
•Remote setting system Ready
•Scan delay
•Pressure graph display
•Duration by phase
•Elapsed injection time indicator
•Remote check for air
•Remote Start
•Test Inject
•Selectable Pressure Limit

1.8 System Response to Occlusions

When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed
rate) or a very high pressure, the system will terminate injection. If the system terminated
injection for stall or high pressure, check the fluid path for blockage and inspect the
disposable set for damage. If no blockage is found consider increasing the catheter size or
decreasing the flow rate. Re-check the fluid path for air before press the “Ready” button then
start to inject.

1.9 Over and Under Injection Protection

The system provides the following means to protect against over and under injections:
Warnings in this manual remind the user to fill syringes only with the minimum amount
of contrast required by the procedure to be performed on the patient and to check the
programmed protocol prior to the system staring injection.
An indication of insufficient volume is provided on the screen when intending to start
injection if the protocol total volume is greater than the amount of fluid in the syringe.
The system detects the delivered volume and terminates the injection once the delivered
volume is same as the total programmed volume for the protocol. When a fault condition,
hold or stop is detected, the injection will stop within 5 mL. Once the system has terminated
the injection a message will be displayed on the console screen.

1.10 Maximum Flow Rate

Using recommended syringe kits, maximum flow rate at 35°C +/-±5°C of contrast with
different cather-over-needle are:
18 Gauge cather-over-needle (BD PN 381144)
• Ultravist 300 8.5 mL/s
• UltraVist 370 8.5 mL/s
•Saline 8.5 mL/s
20 Gauge cather-over-needle (BD PN 381134)
•Ullravist 300 7 mL/s
•UltraVist 370 7 mL/s
• Saline 7.0 mL/s
22 Gauge cather-over-needle (BD PN 381123)
•Ullravist 300 6 mL/s
• UltraVisl 370 5 mL/s
•Saline 6.0 mL/s

User’s Manual 1-9

1.11 Disposables
The use of syringe kit not complying with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of the resulting system. Consideration
relating to the choice shall include evidence that the safety certification of the syringe kits
has been performed in accordance to the appropriate EN 60601-1 and/or EN 60601-1-1
harmonized national standard.
The following syringe kits are verified and recommended to be use with the contrast media
injector:
FDA cleared in K152906
Manufacture: Wuxi Yushou Medical Appliances Co., Ltd
Model: 100200A,
Contents：1-200ml Syringe, 1-150cm One-way Connector tube, 1-J-type Tubular
Medicine Aspirator.
Model: 100100C/100100C
Contents：2-115ml Syringe, 1-255cm Multi-way Connector tube, 2-Punctured
Medicine Aspirator
Model: 100200B/100200B
Contents：2-200ml Syringe, 1-J-type Tubular Medicine Aspirator, 1-150cm
Multi-way Connector tube, 2-10cm Straight Tube, 2-Punctured
Medicine Aspirator
Use only safety-approved catheters suitable for connection to the LLN-K-A Luer
male-threaded locking coupler. The following Cather-over-needle is verified and
recommended to be use with the contrast media injector:
FDA cleared in k151698
Manufacture: Becton Dickinson Infusion Therapy Systems, Incorporated
P/N: BD PN 381144, BD PN 381134, BD PN 381123

Though the system is opened to use disposables from different manufactures, theses
disposables must be compatible with the system and must be CE marked in European
countries or FDA cleared in America market.

1-10 User’s Manual

1.12 Warranty Terms
Shenzhen Seacrown Electromechanical Co. Ltd. and its Distributor warrant to the original
purchaser who purchased the accompanying equipment ("Product") through an authorized
dealer that the Product, including any accessories supplied with the Product, is free from
defects in materials and workmanship for a period of one (1) year from the date of original
purchase.
WARRANTY ON REPAIRED/REPLACED PRODUCTS: Subsequent replacement, resale or
replacement or subsequent repair of the product will not extend the warranty period or
commence a new warranty period. However, any parts that have been repaired or replaced
during the warranty period will be covered by the warranty for the remainder of the
warranty period, or at least for ninety (90) days from the date of repair or replacement.

This warranty is not transferable to third parties, including, but not limited to, subsequent
purchasers or owners of the product. The transfer or resale of any product will automatically
terminate the warranty for this product.
This warranty covers the Product only as originally supplied and is void with respect to the
following:
(i) Products which have been subjected to misuse, abuse, accident, physical damage,
abnormal use or operation, improper handling or storage, lack of proper maintenance,
neglect, exposure to fire, water or excessive moisture or dampness or extreme changes in
climate or temperature; (ii) damage resulted from fire, flood, acts of God or other acts which
are not the fault of Manufacture; (iii) any Products which have been opened, repaired,
modified or altered by anyone other than Manufacture.

Please contact your service representative at the addresses and phone numbers listed in the
foreword for warranty and service questions.

User’s Manual
1-11
2 System Overview
The contrast media injector is comprised of an injector arm, a main controller, and a console.
The console is the primary interactive interface between the system and the user. The hand
switch is basically an on/off button. It gives the user very convenient to control injection by
hand pressing instead of clicking icons on the screen. The injector arm is the system's execution
assembly consisting of ball screws, reduction gears, and motors. The execution assembly
implements injection, filling, and expelling. The injector arm incorporates a portion of the user
interface. The injector arm control board processes the button, limit switch and encoders
signals.
The electric units in the main controller including the main control board, power unit and
motor drivers process user commands from the console and the injector arm, sending back the
processed results to them to be provided to the user. In addition, the motor drivers control the
motor on injector arm to carry out injection, medical fluid suction, and expelling air. The power
unit is sole power source of the system and applies electric power to the console and injector
arm.
Data and commands transmission between the console and main controller is the way of
serial communication. Same is between the main controller and injector arm.
Three configurations of the contrast media injector made by Seacrwon company are defined
into these three modes according the way to install the injector arm: trolley mount, ceiling
mount, and wall mount. This manual is focused on the trolley mount injectors. The users
ordered ceiling mount or window mount should install and use the injector according to
PT-010-218 SAS Instruction Manual.
The manufacture offers the users the IV pole and the heat maintainer as optional parts. The
users ordered the options of the IV pole and the heat maintainer should read PT-010-219 IVPS
Instruction Manual and PT-100-005 HM User’s Manual carefully before installing and using.

User’s Manual 2-1

2.1 Zenith-C11/C22
The Zenith-C11 and Zenith-C22 are dual syringe systems.
The injector arm and main controller of model Zenith-C11/C22 are located in the scanning
room. Its console is typically located in the control room.

Injector arm

Console

Main controller

Zenith-C11/C22

The hardware version number of the Injector main control board is C/1；

The hardware version number of the Injector ARM control board is B/2；

The hardware version number of the Injector console control board is C/1；

The firmware version number of the Injector is V2.1.8;

Disposable and assembly

No. Code Name/Model Material

1 C01-004-03 Syringe 900200A/900200A PC
2 A07110 Movable Pedestal iron
3 E010425 Accessary tray ABS
4 E031007 Casters ABS
5 A01105 Injector Arm ABS

2-2 User’s Manual

6 A07106 Console ABS

User’s Manual 2-3

2.2 Zenith-C20
The Zenith-C20 has one syringe configuration.
Zenith-C20 injector arm is located in the scanning room, while the main controller and
console are typically located in the control room.

Injector arm

Console

Main controller

Zenith-C20

The hardware version number of the Injector main control board is V4.4；

The hardware version number of the Injector ARM control board is B/2；

The hardware version number of the Injector console control board is C/1；

The firmware version number of the Injector is V2.1.7;

Disposable and assembly

No. Code Name/Model Material

1 C01-003-03 Syringe 900200A PC
2 E010002 Movable Pedestal iron
3 E010430 Counter weight iron
4 A80143 Lower straight-bar iron
5 E010425 Accessary tray ABS
6 A80137 Spring arm Aluminum

2-4 User’s Manual

7 E031007 Casters ABS
8 A01105 Injector Arm ABS
9 A01106 Main Control Box LY12/Q235
10 A01113 Console ABS

User’s Manual 2-5

2.3 Specifications
2.3.1 Dimensions and Weights

Assembly of Injector Arm and Main Controller of Zenith-C11/C22

Weigh of: 19.5 Kg
Dimension:

Assembly of Injector Arm and Main Controller of Zenith-C11/C22

2-6 User’s Manual
 Zenith-C20 Injector Arm and Stand

Weight: 16.5 Kg
Dimension:

User’s Manual 2-7

 Zenith-C20 Injector Arm and Stand

Zenith-C20 Main controller

Weight: 6.2 Kg
Dimension:

Zenith-C20 Main controller

Console

Weight: 4.1 Kg
Dimension:

Console

2-8 User’s Manual

2.3.2 Environmental Requirements
Transportation and Storage:
Temperature: -25℃ to 70℃
Humidity: 5% to 100% R.H.non-condensing
Air Pressure: 48kPa to 110kPa

Operating:
Temperature: 10℃ to 40℃
Humidity: 20% to 90% R.H.
Air Pressure: 69kPa to 110kPa

2.3.3 Electrical Requirements

a.c.220V，50Hz，200VA or a.c.110V，50Hz，200VA
2.3.4 Fluid Delivery Performance
Description Specification
Zenith-C11: two 100mL
Syringe System Zenith-C22: two 200mL
Zenith-C20: one 200mL
Volume 0.1 mL to maximum syringe capacity in0.1mL increments
Flow Rate 0.1 to 10 mL/sec in 0.1 mL/sec increments
Programmable
300 psi default, user settable 50 to 350 psi
Pressure Limit
Hold Capability More than 30 minutes.
Injection or Scan
0 to 3600 seconds in 1 sec. increments
Delay
Multi-Phases 1-8 phases per injection
Zenith-C11:1 to 100mL;
Programmed Volume
Zenith-C22 and Zenith-C20:1 to 200 mL
Fill Rate 3.0 to 8.0mL/sec
Pause Programmable- 0 sec. to 999 sec. in 1 sec increments
Autofill Fill rate 3.0 mL/sec to 8.0 mL/sec in 0.1mL/sec increments
Protocol Storage
100 protocols
capability

User’s Manual 2-9

2.4 Injector Arm
Operating the system requires knowledge of the user interfaces located on both the console
and the injector arm.
The injector arm contains a membrane switch and console contains a touch screen display in
order to interact with the user.
Through use of the injector arm, the user can:
•fill/expel syringe(s)
•make system ready
•test injection
•start/stop injection.

2-10 User’s Manual

 Zenith-C11/C22 injector arm overlay:

User’s Manual 2-11

 Zenith-C20 injector arm overlay:

2-12 User’s Manual

2.4.1 Moving Piston Rod

[Expel Air] button

Pressing on the [Expel Air] advances piston rod. Releasing the button will stop the
movement of the piston rod immediately.
If the piston rod is at fully advanced position or the injector being Ready statue, this button
will be unavailable.
The [Expel Air] is used to expel air from the fluid path at a lower flow rate.
The flow rate is programmable through the setup Screen.

[Forward] button
Pressing the [Forward] button fully advances the piston rod. Pressing the [Stop] button
stops the movement of the piston rod.
When the piston rod is at fully advanced position or the injector being Ready statue, this
button will be unavailable.
The [Forward] button is used to expel air from syringe at high flow rate. The flow rate is
programmable through the setup Screen.

[Autofill] button
Pressing on the [Autofill] button less than three seconds fully retracts the piston rod unless
pressing the [Stop] button.
Pressing on the [Autofill] button more than three seconds, the system acts integrated
movements. First the piston rod is retracted to fill the protocoled Autofill volume. Then it will
be advanced to expel the protocoled Auto Expel volume.

[Stop] button
Press this button to stop the movement of the piston rod immediately at any time.

User’s Manual 2-13

2.4.2 Getting System Ready on Arm
The [Ready] button is only active after pressing [Expel Air] button to purge air from both
syringes (piston rod must move forward to expel a minimum of 1 (one) mL of contrast/saline).
After pressing the [Ready] button, the system is Ready to injection and the indicator light
illuminates orange.

Press the [Ready] button only after expelling air and after
completing other preparations (such as checking the
correctness of the injection protocol).

If the system is in Ready status any buttons on the injector arm

will be unavailable. Press [Stop] button is a way to make the
system not ready.

2.4.3 Test Injection

Press [Test] button to start test injection when the injector being Ready. The piston rod will
move from the inner to the outer for protocoled volumes at protocoled flow rate.
The [Test] button is used to check whether the venipuncture procedure is correct and safe.
The flow rate and volume can be programmed through the setup Screen.

It is very important way to improve the safety of the injection

and to check whether the venipuncture procedure is correct.
The system should always perform the test injection before
beginning to inject automatically.

2.4.4 Controlling Injection

When the injector is ready and accesses the Injection screen on the console, press the [Inject]
button to start injection.
Press the [Stop] button to stop injection.

2.4.5 Volume Display

The displayed volume on the digital LED indicates the volume that the syringe should
contain as it corresponds to the current position of the piston rod of the injector arm.

2.4.6 System Status

(Zenith-C11/C22 Only)
When the system is powered on and operates normally, the status indicators will light in
green.
The status indicators will light in orange after the [Ready] button on the injector arm is
pressed or the console has accessed the Injection screen.
The indicator flashes in orange indicating the system is injecting with the flashed syringe.
When the system detected some part malfunction, the indicators will light in red.

2-14 User’s Manual

User’s Manual 2-15
2.5 Console
Through use of the console’s touch screen display, the user can:
•enter protocol parameters
•save protocols
•delete protocols
•recall protocols
•ready/start/pause/stop a KVO injection
•ready/start/pause/stop an injection
•review achieved parameters of delivered protocols
•setup system parameters
•read operation guide

2.5.1 Console Buttons

Three buttons are located on the console.

[ ] Button
[S] Button
[I] Button

Console Buttons

All buttons are active on the Home Screen.

[ ]
The [ ] button turns on or off only the LCD power.

[S]
Press the [S] button to access the Protocol Screen. The current protocol display on the Home
Screen will be saved by inputting protocol name and clicking the [Save] icon.
When the system is in the inject screen, the current injection stage is syringe I, and the next
stage is in syringe II, press the [S] button, the system will stop the injection process of syringe I
and begin to inject for syringe II automatically.
[I]
The [I] button is designed to control injection and renew the console software.
Press the [I] button to start inject. When the system is injecting, pressing the [I] button can
pause inject.
When a flash disk storing console software is connected to the console USB socket, pressing
the [I] button will start to renew the console software. The console buzzer will make sounds till
the updating finished. The system will run on updated software after reboot.

2-16 User’s Manual

2.5.2 Console Display Screens
Start screen— Upon power-up, this screen is automatically displayed. Four notional flags,
representing Chinese, English, German, and French, are located along lower right corner of the
display. The user has 8 seconds to select the system language by clicking one of the national
flags to select its native language. After displaying the Start screen for 8 seconds, the system
will display the Home Screen in selected language or in the language last selected if not clicking
any flag.
Located along the lower portion of the console display are the following 5 icons: [Home],
[Protocol], [System], [History] and [Help]. These icons allow access to their respective
modes of operation.
Home Screen — The system will enter the Home Screen after the start screen is displayed
for 8 seconds. All protocol information needed by the system is contained within the Home
Screen. To access the Home Screen when displaying any other screen, click the [Home] icon
located on the lower right-hand side of the screen.
Protocol Screen — All stored protocol information can be searched within the Protocol
Screen. Accessing this screen allows the user to recall, store, rename and delete protocols. To
access the Protocol Screen, click the [Protocol] icon located on the lower portion of the Home
Screen.
System screen — Accessing this screen allows the user to set parameter defaults, change
the language, set the time, perform detections or calibrations, and read the product information.
To access the System screen, click the [System] icon located on the lower portion of the Home
Screen.
History Screen — All information pertaining to the results of a delivered injection is located
within the History Screen. To access the History Screen, click the [History] icon located on the
lower portion of the Home Screen. The Home Screen appears after a self-checking sequence is
performed. All other screens are accessed from the Home Screen.
Help Screen — To access the Help Screen, click the [Help] icon on the lower portion of the
Home Screen. The Help Screen information includes the operation guides to power on/off the
system, prepare injection, control and injection.

User’s Manual 2-17

 2.5.3 Home Screen

Zenith-C11/C22 Home Screen

Syringe volume

Protocol Name
Volume Injection Delay

Flow Rate Previous Page

Duration Pressure limit

KVO
Phase Attribute Next Page
Total Duration
+
Ready

Total Volume

Home Screen of Zenith-C11/C22

Zenith-C20 Home Screen

Syringe
Volume
Protocol name
Volume Injection Delay

Flow Rate
Previous Page
Duration Pressure Limit
Ready
Next Page
Phase Attribute
【+】Icon
Total time
Total Volume

Home Screen of Zenith-C20

2-18 User’s Manual

 The information displayed on the Home Screen which could not be programmed directly is
the following:

“Syringe Volume”
“Syringe Volume” indicates the relative position of the plunger in the syringe thus
indicating how much fluid may be in the syringe.

“Total Volume”
“Total Volume” is the total volume programmed to be delivered in a protocol for a syringe.

“Duration”
The value in this column indicates the duration of a protocol phase (i.e., time to complete
injection in seconds) based on the entered volume and flow rate values.
The sum of all phase durations is displayed at the end of this column on Zenith-C11/C22
screen, but in the Total Time column in Zenith-C20 screen.

“Protocol Name”
The name of the protocol currently displayed on the Home Screen is located in this area of the
screen.
The injector can store as many as 100 sets of injection protocols, each of which has an
identification number defined as Protocol name.

User’s Manual 2-19

 The following parameters can be setup by the user:

[Flow rate]
The values entered in this column indicate rate of delivery of the contrast medium and saline
during each respective phase. Flow is expressed in milliliters/second.
The values can be set by clicking the number area.

[Volume]
The values entered in this column indicate the volume of contrast medium and saline to be
delivered during each respective phase. Volume is expressed in milliliters.
The values can be set by clicking the number area.

[Injection Delay] or [Scan Delay]

The value entered in this column is time of injection or scan delay. The text at above this
column defines injection or scan delay.
Inject Delay is a countdown timer that begins counting when the Inject command is
activated. The injection is started when the inject delay counter reaches 0 (zero).
Scan Delay is a countdown timer that begins counting when the Start command is activated
and stops when the counter reaches 0 (zero). The scan start signal will initiate once the timer
reaches 0 (zero).

[Pressure Limit]
The value entered in this column is pressure limit. The pressure limit is the maximum thrust
which the injector can provide. When the required power to implement the protocol injection is
greater than the maximum thrust, the injector can’t complete correctly in accordance to the
protocol parameters.

2-20 User’s Manual

 [Phase Attribute]
Located along the left line of the screen are [Phase Attribute] icons. The number on the
icon indicates the Phase order, and the character indicates the Phase Attribute.
Click any one of [Phase Attribute] icons and the Phase Attribute setup window appears.

Phase Attribute setup window of Zenith-C11/C22

Phase Attribute setup window of Zenith-C20

The abbreviations of the words on the Phase Attribute setup windows are the following
characters: I,Ⅱ, I+Ⅱ, H, and P.
I is the abbreviation of Injection on Zenith-C20 screen, Syringe I on Zenith-C11/C22 screen.
Phase Attribute I indicates injecting from the syringe (Syringe I of Zenith-C11/C22 ).
Ⅱis the abbreviation of SyringeⅡ. Phase Attribute Ⅱ indicates injecting from syringe Ⅱ.
I+Ⅱis the abbreviation of Syringe I+Ⅱ. Phase Attribute I+Ⅱ is defined as mixture injection.
It indicates injecting from syringe I and syringe Ⅱat the same time. The flow rate column
defines the final delivery rate added by the rate of the two syringes. The volume column
contains three parameters. The right part defines the sum of volume will be delivered from the
two syringes. At the left there are two percentages to define the ratio of the volume will be
delivered from syringe I and Syringe II. Above percentage defines the ratio for syringe I, and low
for syringe II.
As an example, calculate the flow rate and volume for each syringe in the protocol on the
Home Screen in Page 26. Phase 4 is mixture injection of flow rate 5.0mL/s and volume 80mL.
The duration is 16 second (80mL over 5mL/s). The syringe I will deliver 48mL (60% of 80mL) at
flow rate 3mL/s (48mL over 16 second). The syringe II will deliver 32mL (40% of 80mL) at flow
rate 2mL/s (32mL over 16 second).
H is the abbreviation of Hold. Phase Attribute H indicates Hold. When injection procedure
goes to Hold phase, the injector will suspend injection. Click [Continue] icon or press the hand
switch to continue the injection. Click the [Stop] icon to stop the injection.
P is the abbreviation of Pause. Phase Attribute P indicates Pause. When injection
procedure goes to Pause phase, the injector will suspend injection. Pause time is a countdown
timer that delays the start of the next phase. The next phase will start when the pause time
counter reaches 0 (zero).
Click [Delete] icon to delete the selected phase. Click [Cancel] icon to cancel editing
protocol.
User’s Manual 2-21
 The function icons on the Home Screen are following:

[+] icon
Click [+] icon to insert a new phase.

[ ∧ ] and [ ∨ ]icons
[ ∧ ]- Previous Page icon
[ ∨ ]- Next Page icon
Because on the Home Screen only four protocol phases could be displayed, the two icons help
user to check all phases of protocol of more than four phases.

[Ready] icon
Click the [Ready] icon on the Home Screen to access the Injection screen.

2-22 User’s Manual

 Injection Screen

Inject

Pressure Profile
Bolus Tracking

Home

Injection Screen of Zenith-C11/C22

【Inject】
Injection Pressure
Curve

【Home】

Injection Screen of Zenith-C20

User’s Manual 2-23

2.5.4 Protocol Screen
Click the [Protocol] icon on the Home Screen to access the Protocol Screen on which the
user can store or recall injection protocols.
The system can store up to 100 eight-phase protocols. Each protocol can have a name
consisting of up to 20 alpha-numeric characters.

Recall Home

Save

Protocol Screen

2-24 User’s Manual

 Store Protocol

Click [Save] icon of the Store or Recall Protocol Screen to access the Store Protocol Screen.

Store Protocol Screen

Input a name for the displayed injection parameter and click [Save] icon in above screen to
store a new protocol. If the name is duplicated, a notice will appear to guide you to rewrite
protocol with new parameters by clicking [OK] icon or discard any change to previous protocol
by clicking [Cancel] icon.

Notice of duplicated protocol name

User’s Manual 2-25

 Recall Protocol

Click [Recall] icon on the Protocol Screen to access the Recall Protocol Screen. A segment of
stored protocols will be displayed on the left of the screen. Use [Previous] or [Next] icon to
view all stored protocols. The right of the screen displays one protocol with its name and
parameters. Click [Select] icon on this screen to select displayed protocol and return to Home
Screen.

Recall Protocol Screen

2-26 User’s Manual

 Delete Protocol

On Recall Protocol Screen click [Delete] icon to delete the protocol selected.

Notice to delete protocol

Click [ok] icon to confirm to delete the protocol.

Click [Cancel] icon to return to Recall Protocol Screen without deleting.

User’s Manual 2-27

2.5.5 System Setup and Test Screens
Click the [System] icon on the Home Screen to access the first screen of the System Setup
and Test Screens.
The Zenith-C11/C22 console screen is used to describe system setup and test. Except KVO
and Bolus Tracking, the single syringe system console has the same setup and test with the
Zenith-C11/C22.

Parameter Setup Screen of Zenith-C11/C22

Parameter Setup Screen of Zenith-C20

2-28 User’s Manual

 Parameter setup
Click [Parameter] icon to access the Parameter Setup Screen. All parameters can be set by
clicking their value columns. Click any programmable block. The selected block will be blank. A
numeric keypad and parameter range window appears. Enter the desired values.

•Expel Rate, ranged from 0.1 mL/sec to 0.6 mL/sec, is the flow rate of the system when
[Expel Air] button being pressed.

•Rew Rate, ranged from 3.0 mL/sec to 8.0 mL/sec is the flow rate after press [Autofill]
button.

•Expel Air Fast Rate, ranged from 3.0 mL/sec to 8.0 mL/sec, is the flow rate after press the
[Forward] button.

•Autofill Volume, ranged from 0.0 mL to 200.0 mL, is the volume of autofill after press
[Autofill] button on for more than 3 seconds.

•Autofill Rate, ranged from 3.0 mL/sec to 8.0 mL/sec, is the flow rate after [Autofill] button
on for more than 3 seconds.

•Auto Expel Volume, ranged from 0.0 mL to 10.0mL, is the volume of expel air of the
autofill protocol.
When using a Quick Fill Tube (QFT), program the expel volume being 30 mL.
For other filling devices, consult the manufacturer’s instructions for use.

•Test Rate, ranged from 0.1 to 5.0 mL/sec, is the flow rate of test injection.

•Test Volume: Ranged from 0.1 to 10.0 ml is the volume of test injection.

User’s Manual 2-29

 KVO Parameter setup

Click [KVO] icon to access the KVO Parameter Setup Screen. On this screen click the pane
before a flow rate to select it as KVO injection flow rate. The √ symbol directs the language
selected.

KVO Parameter Setup Screen

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 Bolus Tracking Parameter

Bolus Tracking Injection --an injection of a small volume of contrast, followed by a small
volume of saline--can be delivered to the patient to determine the optimal scan delay needed to
capture the contrast agent in the area of interest.
Bolus Tracking is programmable protocol with two phases, and users can set the protocol
parameter. Click [Bolus Tracking] icon to access the Bolus Tracking Parameter Setup Screen.

Bolus Tracking Parameter Setup Screen

On this screen click the pane before Bolus Tracking Switch to display √ to enable the Bolus
Tracking. When the Bolus Tracking is enabled, the Bolus Tracking icon is on the Injection
screen (chapter 5.7). When the pane is blank, the Bolus Tracking is not enabled and no Bolus
Tracking icon is on the Injection screen.
Click value columns to input desired flow rate and volume values.

User’s Manual 2-31

 Language Selection

Click [Language] icon to access the Language Selection Screen.

Language Selection Screen

The √ symbol directs the language selected. The system screen language can be selected in
Chinese, English, German or French.

2-32 User’s Manual

 Date and Time setup

Click [Date] icon to access the Date and Time Setup Screen.

Date and Time Setup Screen

Click the relevant up and down arrows to set the time and date. The modification would be
stored by clicking the [Save] icon. If not clicking the [Save] icon, the setup value would be
ignored.

User’s Manual 2-33

 Detection

Click the [Detection] icon to access the Arm Button Test Screen.
The system will not do anything except test when the system is in the Arm Button Test
Screen.

Arm Button Test Screen

Press all buttons orderly on the system arm panel. The cycle on the screen with the same
name as pressed button should be replaced by √. If there is any button name followed with √ on
the screen without pressing same button or not response for any pressed button, the arm panel
was defected.

2-34 User’s Manual

 Detection

Click [Next] icon on the Arm Button Test Screen. Test Screen to assess the Sensor Test
Screen to check the sensors.

Sensor Test Screen

After confirming no syringe was installed, click [Start] icon to start testing. The user can
stop the testing by clicking the [Stop] icon. The √ symbols will display for the sensors in good
conditions in the testing. The sensor would be defected if there is no √ symbol with is after the
test.
The values with the encoders should change continuously and should be around 200. If there
is not any change of an encoder digital, this encoder would be defected.

User’s Manual 2-35

Calibration

Click the [Calibration] icon to access the Volume Calibration Screen.

Volume Calibration Screen

The volume calibration should be run after any limit switch adjusting or injection pressure
error reported.
After confirming no syringe was installed, click [Start] icon to start calibration. The values
should be 0.0 after the calibration finished.

Volume Calibrating Screen

User can stop calibrating by clicking the [Stop] icon at any time.

2-36 User’s Manual

 Product Information

Click the [Product Inf.] icon to access the Product Information Screen.

Product Information Screen

On this screen the user can get the product information, including the manufacture
information, product model, serial no., software version, service contact phone no..

User’s Manual 2-37

2.5.6 History Screen
Click the [History] icon on the Home Screen to access the Injection Record Screen.

History Date

Previous Page

Next Page

Review Injection Record Screen

The system saves all injection data in reverse chronological order. The injection records
include the protocol, elapsed time, injected volume, etc.
Click the [ ∧ ] icon or [ ∨ ] icon to search the date you intend to view. Click the line labeled
date and time to view this injection record.
Click the search icon and input the date to get directly the injection records completed in that
day.
The user can delete the selected record by clicking the [Delete] icon.

2-38 User’s Manual

2.5.7 Help Screen
The Help Screen can be accessed by clicking [Help] icon on the Home Screen.

Help Screen

The Help Screen contains information about:

•The system safety warning
•The procedures to perform injection.
Clicking [ ∧ ] and [ ∨ ] to search the information you concern.

User’s Manual 2-39

2.6 Main Controller
The primary functions of the main controller are to control and process communications
with the console, control the motor driver, and to provide power to the system.
Components of the main controller include: main control board, system power units, and
motor driver(s).

2-40 User’s Manual

 This page intentionally left blank.

User’s Manual 2-41

3 Power On/Off
3.1 Turning the System Power On
At the front of the main controller, place the switch to the ON position.
The indicators located on the top of the Zenith-C11/C22 injector arm and the light located in
the Zenith-C20 main controller power switch will illuminate green indicate the system power is
ON.
The console has its own power switch. At the rear of the console, place the switch to the On
position. The Start screen is displayed to indicate the console power is On and the console
computer starts power –up check sequence.

自 动 推 注 系 统
Contrast Deliery System

Zenith-C11/C22 Main controller power switch Zenith-C20 Main controller power switch

Console power switch

User’s Manual 3-1

3.2 Turning the System Power Off
At the front of the main controller, place the switch to the OFF position to switch the system
power. The console can be left ON. This allows for quicker and easier restarts the console.

3-2 User’s Manual

4 Readying Sequence
This chapter discusses the proper techniques for programming protocol, loading syringe(s),
filling syringe(s), purging air from the syringe(s) and tubing, priming the tubing, connecting the
patient, and setting the system ready to inject.
The following instructions apply to Zenith-C20 or Zenith-C11/C22, except the instructions on
two syringes, KVO, and Bolus tracking only for Zenith-C11/C22.

AIR EMBOLISM COULD CAUSE PATIENT INJURY OR DEATH!

Always verify all air in the fluid path have been expelled before
connecting the system to the patient.
The user is responsible for removing all air from the system.
To minimize air embolization risks, ensure that one user is
designated to complete all injection procedures. If the user must to be
changed, ensure that the new user verifies that no air in the fluid
path.

THE OCCURRENCE OF CROSS-CONTAMINATION AND INFECTION

WILL CAUSE SERIOUS HARM TO THE PATIENT!
Do not reuse any disposables.
Using aseptic technique, install syringe, connect tube and connect to
patient.
Syringe may not be used to store liquid for long periods of time.
Do not remove the plunger to fill the syringe.
Do not use disposables whose packaging has been opened or
damaged.

NON-COMPLIANT DISPOSABLES COULD RESULT IN PATIENT

INJURY, OPERTOR INJURY AND/OR QUIPMENT DAMAGE.
Use the certified consumables recommended in this manual.

IMPROPER MEDICAL FLUID VOLUME AND FLOW RATE MAY

HARM PATIENTS.
Review Parameters! Prior to starting an injection, review all
parameters thoroughly to ensure that they are correct and
appropriate for the procedure.

Rotate injector arm down prior to injecting

Preheating the contrast media will help in the removal of air bubbles.

User’s Manual 4-1

4.1 Deciding on Injection Protocol
The injection protocol which the system will inject according to is the protocol currently
displayed on the Home Screen. The injection protocol can be programmed on the Home Screen.
A stored protocol can be called to be the injection protocol.

4.1.1 Programming Protocol

Refer to 2.5.3 Home Screen.
1. Click [+] icon to add a phase.
2. Click a [Phase Attribute] icon to change Phase Attribute.
3. Click any programmable block, such as Flow Rale or Volume or Delay or Pressure Limit.
The selected block will be blank. A numeric keypad and parameter range window appears.
Enter the desired values.
4. Click [Pressure Limit] column the Pressure limit setup window appears. Pressure is
expressed in either PSI or kPa. Select pressure unit on this window.

Pressure limit setup window

5. Click [Injection Delay] (may be [Scan Delay] ) column the Delay setup window appears.
Select Injection or Scan Delay on this window.

Delay setup window

On all numeric keypad and parameter range windows, click [ok] icon to save the new values,
or click [Cancel] to complete setup and remain original values..

Refer to 2.5.4 Protocol Screen to store a protocol.

4-2 User’s Manual

4.1.2 Recalling Protocol
Refer to 2.5.4 Protocol Screen.
Click [Recall] icon on the Protocol Screen to access the Recall Protocol Screen. A segment of
stored protocols will be displayed on the left of the screen. Use [Previous] or [Next] icon to
view all stored protocols. The right of the screen displays one protocol with its name and
parameters. Click [Select] icon on this screen to select displayed protocol and return to Home
Screen.

Recall Protocol Screen

User’s Manual 4-3

4.2 Installing Syringe

The occurrence of infection will cause serious harm to the patient. Do

not touch the interior of the syringe or expose the interior of the
syringe to prevent contaminating the syringe.

Ensure that the piston rod has been fully retracted, or pressing the [Autofill] button retracts
piston rod till it stopping automatically.
Get syringes out of packages (attention aseptic operation).
Hold on the middle part of the syringe with right hand to make the frame and circular ears
align the frame and circular notches of the syringe chuck on the injector arm separately.
Insert the Syringe into the syringe chuck until the syringe limit piece contact the plane.
Rotate the syringe by 90ºin clockwise and finish the installing.

Insert the syringe into the chuck Rotate the syringe by 90ºin clockwise

4-4 User’s Manual

4.3 Filling Syringe
Refer to the following figures to fill syringe(s).

Fill syringe right handed/left handed

1. Press the [Forward] button to quickly push the piston rod to the front end of the syringe.
After installing the syringe,
2. Rotate the injector arm to the vertical position.
3. Remove the protective cap from the syringe tip and store in a safe place for reuse in step 8.
4. Install the spike or slide the end of the shorter section of the QFT over the syringe tip. DO
NOT TOUCH THE TIP.
5. Insert the spike or place the end of the longer section of the QFT into the container of
medical fluid. To keep aeration to a minimum, verify that this end of the QFT is in the
media and is NOT drawing air.
6. Press [Autofill] button following 4.3.1 to fill syringe manually or 4.3.2. to fill syringe
automatically.
7. Carefully remove the spike or QFT from the syringe tip by twisting while pulling off.
8. To prevent contamination, replace the protective cap on the syringe tip. The injector arm
should remain in the vertical position (to prevent leakage) until ready for injection.

User’s Manual 4-5

4.3.1 Filling Syringe Manually
Press on the [Autofill] button and the piston rod is retracted to drawing the fluid into the
syringe. Press the [Stop] button when either sufficient contrast medium or all of the contrast
medium in the bottle has been drawn up.

4.3.2 Filling Syringe Automatically

Refer to 2.4.5 System screen to set the desired parameters of Autofill.
The Auto-Fill sequence is designed to automatically fill the syringe while minimizing the
introduction of air to save operation time.
Press on the [Autofill] button more than three seconds. The system will automatically
retract piston rod and expel air.
Pressing the [Stop] button on the injector arm will stop the Auto-Fill sequence.
Carefully remove the QFT from the syringe tip by twisting while pulling off.

4-6 User’s Manual

4.4 Attaching Tubing to Syringes
Using aseptic technique, attach the tubing to syringes as following steps:
1. Remove the connector tube from the package.
2. Remove the dust covers to expose male and female luer fittings.
3. Attach the connector tube to the syringe.
If you are using a connector tube with a T-connector, attach the straight portion to the
contrast SyringeⅠ and the extension to the saline Syringe Ⅱ.

T-connector tube to Syringes of Zenith-C11/C22

Connector tube of Zenith-C20

4. Verify that the connector tube is not kinked or obstructed.

User’s Manual 4-7

4.5 Purging Air from Syringe
Keep the injector arm to the vertical position (90º) to point the tip of the syringe(s) upward to
allow any air bubbles or the air pocket to rise to the tip.
Pressing on the [Expel Air] button advances the piston rod to push the air pocket out the
syringe tip(s) and through the tubing. The system requires a minimum of 1 mL of piston rod
movement to allow the system to be ready for a procedure.
Verify that both the syringe have been properly cleared of all air.

If bubbles appear in the syringe DO NOT hit the syringe to remove them.
Reverse the plunger 3-5 ml, then rock the injector arm on the pivot to
gather and accumulate the small bubbles. Expel the remaining air.

4-8 User’s Manual

4.6 Priming Tubing
4.6.1 Priming Tubing with Saline
Prime the tubing with saline if KVO injection is to be performed.
Press the [Expel Air] button of the contrast SyringeⅠin order to push contrast just past the
T-intersection of the T-connector tube.
Press the [Expel Air] button of the saline syringe to push the saline past the T-intersection
and out through the remaining tubing.
Verify that all air has been removed from the syringes and tubing.

4.6.2 Priming Tubing with Contrast

Press the [Expel Air] button of the saline Syringe Ⅱ in order to push saline just past the
T-intersection of the T-connector tube.
Press the [Expel Air] button of the contrast syringe Ⅰto push the contrast past the
T-intersection and out through the remaining tubing.
Verify that all air has been removed from the syringes and tubing.
With all air removed and the tubing primed, the injector arm should remain in the vertical
position to prevent leakage until ready to inject. Once press the [Ready] button or access
Injection screen on the console to make the system being ready, the injector arm should be
rotated about 45°below horizontal.

Injector arm in below horizontal position

4.7 Connecting to Patient

Follow proper venipuncture technique to connect the patient to the system. Have at least
1/2 inch of the catheter positioned in a good vein. After correct venipuncture, tape the catheter
securely to avoid catheter movement.

The connection of the syringe, tubing and cather-over-needle relies on luer

tapers. Make sure the connection is tight so as to avoid leakage while
injecting.

User’s Manual 4-9

4.8 Getting System Ready on Console
The operator is responsible for ensuring that all air has been completely evacuated from the
syringe and tubing prior to delivering the injection. Prior to Ready an injection, review all
parameters thoroughly to ensure that they are correct and appropriate for the procedure. Also,
ensure that the contrast fluid is installed on the correct side of the injector arm. Follow the
Ready Sequence stated in Chapter 4 to load and fill syringes properly, purge air and prime the
tubing.
Rotate the injector arm at least 30°below horizontal. This safety precaution reduces the
possibility of an air emboli. Any small remaining air bubbles will tend to float away from the tip
and will not be injected into the patient.
To ready the system, the user can press the [Ready] button located on the injector arm or
click the [Ready] icon on console screen.
The following two requirements should be complied to ready the system:
1. The user has Pressed [Expel Air] buttons to purge air from both syringes (piston rod
must move forward to expel a minimum of 1 (one) mL of contrast/saline).
2. The syringe volume is sufficient to deliver the total volume.

Before expelling air clicking [Ready] button (icon), a notice to expel air window appears.

Notice to expel air

If the total volume programmed to be delivered is greater than the amount of fluid in the
syringe and the [Ready] icon is clicked, a notice of insufficient volume.

Notice of insufficient volume

4-10 User’s Manual

 When the two conditions are matched, clicking the [Ready] icon successfully access the
Injection screen.

Inject

Pressure Curve
Bolus Tracking

Injection Screen of Zenith-C11/C22

【Inject】

Pressure Profile

【Home】

Injection Screen of Zenith-C20

User’s Manual 4-11

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4-12 User’s Manual

5 Performing Injection
Before starting injection, user should do the following:
• Ensure all air has been expelled from the fluid path.
• Ensure the programmed parameters are correct.
• Make CT scanner in the controllable and beginning state, namely button pressing can
confirm time of beginning scan.
•Perform test injection to confirm the correctness of venipuncture.

DANGER! AIR EMBOLISM HAZARD!

Air entrapped in the syringe and tubing can cause patient injury or
death. Always verify that both the syringe and tubing have been
properly cleared of air just prior to starting the injection! The system
does not have the capability to check for air in the syringe and tubing.
The operator is responsible for removing all air from the system.

REMOVE SYRINGE AFTER COMPLETION OF INJECTION!

Disposable syringes are designed for single use only. Used syringes
should be promptly removed from the injector after a procedure is
completed to avoid accidental reuse of an empty syringe. Failure to
remove the syringe after completion of a procedure may lead to an
inadvertent injection of air. Injecting air can cause patient injury or
death.

User’s Manual 5-1

5.1 Reviewing Parameters
Prior to delivering an injection, review all parameters thoroughly to ensure that they are
correct and appropriate for the procedure. Also, ensure that contrast fluid is installed on the
correct side of the powerhead.
Refer to 4.1.1 or 4.1.2 to set desired parameters or recall desired protocol.

5-2 User’s Manual

5.2 Test Injection

Extravasation can be minimized through the following precautions:

• When choosing an I.V. site, use the largest vein possible.
• Use lowest flow rate practical to achieve enhancement.
• Use largest gauge teflon type catheter possible.
• Insure good backflow from catheter.
• Continue to monitor from remote location.
• Instruct patient to notify operator of any abnormal pain, pressure or
swelling.
Test injection aims to check the patency of the I.V. site and to reduce the risk of the
extravasation.
The [Test] button is active when the system is Ready.
Refer to 4.8 to Ready the system.
The Test injection flow rate and volume can be programmed on the System setup and test
screen. Refer to 2.5.5.
After Test injection, there should be no swelling at the venipuncture point. If there is swelling,
you should perform venipuncture again before protocol injection.
The users can also do backflow test to make sure the venipuncture is correct. Press the [Stop]
button to set the system being not Ready status, then continually press the [Test] button to
check if there is blood in the Cather-over-needle.

User’s Manual 5-3

5.3 Running KVO Injection
Refer to 2.5.3, and 2.5.5.
KVO is the abbreviation for Keep Vein Open. It is a low flow rate injection of a small volume
of saline delivered to keep the fluid pathway open.
The system runs KVO by injecting fluid from syringe Ⅱ.
Run the KVO for a patient who has been connected to the system for five minutes to waiting
for injection.
The [KVO ON] icon and [KVO OFF] icon on the Home Screen control the KVO program
running.
When the system is Ready, click [KVO ON] icon to run KVO injection. When the system run
KVO injection, the [KVO ON] icon is replaced by [KVO OFF] icon and a message “KVO is
running” is display at the right bottom corner of screen.

KVO running message

Click [KVO OFF] icon to stop running KVO injection.
The user can program the KVO protocol on the System screen. Refer to Chapter 2.5.5.
When the [Expel Air] buttons were not both pressed or there is not sufficient volume in
syringes, the below notices remind the user to expel air or fill syringe.

Notice to expel air to run KVO injection

Notice of insufficient syringeⅡvolume

5-4 User’s Manual

5.4 Bolus Tracking Injection
Refer to Chapter 2.5.5 to set bolus tracking injection enable and its parameters.
Click [Bolus Tracking] icon on the Injection screen to access the Bolus Tracking Injection
Screen.

Inject

Return

Bolus Tracking Injection Screen

Click [Inject] icon to start injection.

Pause

Stop

Bolus Tracking Injection Screen

User’s Manual 5-5

 Click [Pause] icon to suspend injection and Click [Continue] icon in the suspend screen to
inject again. Click [Stop] icon to stop injection.

Continue

Stop

Bolus Tracking is suspend screen

5-6 User’s Manual

5.5 Protocol Injection

Air entrapped in the syringe and tubing can cause patient

injury or death. Always verify that both the syringe and tubing
have been properly cleared of air before connecting to the
patient and just prior to starting the injection! The system
does not have the capability to check for air in the syringe and
tubing. The user is responsible for removing all air from the
fluid path.

REVIEW PARAMETERS
Prior to delivering an injection, review all parameters
thoroughly to ensure that they are correct and appropriate for
the procedure.

User’s Manual 5-7

5.5.1 Starting Protocol Injection
The protocol can be delivered by pressing the [Inject] button on the injector arm, by clicking
the [Inject] icon on the Injection screen or by pressing the hand switch. Once the injection is
initiated, the Injecting Screen is displayed.
While injecting, Total Time increments and syringe volume decrement. The contrast and
saline delivered volume is updated on the console screen during the Injection.
The [Pause] icon is available to pause the injection, and the [Stop] icon to stop the injection
at any time.
Note that the Pressure Limit parameter is indicated by the red line. The real-time injecting
pressure curve is displayed on the console screen.

[ Pause ]

[ Stop ]

Injecting Screen of Zenith-C11/C22

【Pause】

【Stop】

Injecting Screen of Zenith-C20

5-8 User’s Manual

5.5.2 Pausing an Injection
An injection may be immediately paused by pressing the [Pause] icon on the console display
or by depressing once on the hand switch. When the injector is paused, Protocol injection
suspend screen appears.

【Continue】

【Stop】

Protocol injection suspend screen of Zenith-C11/C22

【Continue】

【Stop】

Protocol injection suspend screen of Zenith-C20

User’s Manual 5-9

5.5.3 Restarting an Injection
Click the [Continue] icon or press hand switch to continue the injection process.

5.5.4 Terminating an Injecting

The injection process can be stopped immediately by pressing the [Stop] button on the
injector arm or by clicking the [Stop] icon on the Injecting Screen.

5-10 User’s Manual

5.6 Removing Syringe
Dismount the Y-connector tube from the syringes and press the [Autofill] button to move the
piston rod to the fully retracted position and then remove the syringe by twisting
counterclockwise 1/4 turn and pulling out.

All disposables are intended for single patient use only. When
those unloading should be disposed according the local related
laws and regulations.

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5-12 User’s Manual

6 Installation
Carefully check the packing carton before unpacking. If the packing case is damaged, the
inner equipment may be broken. If there is damage to the case, do not unpack the case, but
take photographic evidence and contact your supplier.
When unpacking the case and if there is anything missing or damaged, take a note and
contact your supplier. Check off all the parts against the content of packing list and note the
condition of items.
The following tools are needed to install the system:
•13mm solid wrench
•5 inch diagonal pliers
•5mm hex head wrench
•6mm hex head wrench
•3mm hex head wrench
•Cross screwdriver

6.1 Assembling Parts

6.1.1 Assembling Parts of Zenith-C11/C22
1. Install the castors of main controller
Screw the castors to the nuts on the main controller by a solid wrench.

Castor with brake

Castor with brake

Main controller

Install castors

User’s Manual 6-1

 2. Connect injector arm with supporting elbow pipe
First screw out the M5*8 socket head cap screw on the spindle of the injector arm with
5mm hex head wrench. Insert the spindle into the pipe. Through the hole of pipe
Tighten the M5*8 socket head cap screw to the spindle.

Injection Arm

M5*8 Screw

Supporting elbow pipe

Connect injector arm with pipe

6-2 User’s Manual

 3. Install the pipe onto the main controller cover
a) Screw out four M6*25 socket head screws to separate the main controller cover from
the main controller base with a 6mm hex head wrench.

Shell

M6*25 Screws

Base

Separate the main controller cover from the base

b) Insert the pipe with all cables into the main controller cover hole. Turn the pipe at
the same direction as the following figure and stop it at the position of a nut on the
main controller cover meeting the hole on the pipe.
c) Tighten four screws.

M6*20 screw
This screw should tighten
3*M6*10 through the pipe.

Shell

Fix elbow pipe with main controller cover

User’s Manual 6-3

 4. Connect the cables to the main controller

Take care to connect the cables in correct direction. Wrong

direction or unmatched connection could result part
malfunction.
Three cables from the injector arm through the pipe need be connected to the parts on
the main controller base.
a) Put down the injector arm, elbow pipe and the main controller cover as the
following figure showing.

Opening the main controller cover for cable connection

b) The parts located on the main controller base that having cables to connect the
injector arm are the following parts:
Driver A④, Driver B⑨ and main control board⑧.
Connect labeled A07011-A cable to driver A, and labeled A07011-B cable to driver B,
and labeled A07012 cable to JP3 of the main control board.

○
9
○
5

○
2
○
4
○
1

○
3

○
6
○
8
○
7

Parts on the main controller base

6-4 User’s Manual

 5. Combine the main controller
After connect all injector arm cables to the main controller base, take the main
controller cover to cover on the main controller base. Tighten four M6*25 screws.

Take care to avoid compressing cables by the edge of the main

controller cover.

M6*25

Install the main controller cover onto the main controller base

6. Install the tray

With cross screwdriver tighten two M4*20 screws through the tray holes to the pipe.

Tray

2*M4*20
Install the tray

User’s Manual 6-5

6.1.2 Assembling Parts for Zenith-C10
1. Installation of lower straight-bar, iron plate , and the movable pedestal
Screw the castors to the nuts on the pedestal by a solid wrench. The castors with brake
should be placed alternatively by a castor without brake.
By screwing the M10 bolt through the iron plate and the pedestal to the lower
straight-bar’s nut to combine the three parts.

Iron Plate
M10*30 Screw
Castor with brake

Pedestal

Upright tube

2. Install cantilever
Put the axle sleeve into the upright tube at the location of the pin of sleeve in hole on
tube. Tighten two M4 screws to fix the cantilever and limit its rotation angles.

Cantilever

M4 Screw

Location pin

M4 set screw

Axle

Axle sleeve

Location hole

Installation Cantilever

6-6 User’s Manual

 3. Install the tray
Place the accessory tray in the correct position. Screw tightly the two M4 screws below
the tray.
Tray

M4*20 Cross recessed pan

head screws with Flat
Washer and Spring
Washer

Install the accessory tray

4. Installation of injector arm

First unscrew the M4*8 set screws from the upper of cantilever, insert the swivel on the
injector arm into the hole, which at the upper of cantilever, regulate the degree of
tightness of the set screws, then fixed it.
The Injector Arm

M4*8 Set Screw

Installation of injector arm

User’s Manual 6-7

6.2 Locating Parts
6.2.1 Locating Parts of Zenith-C11/C22
1. Placed the injector arm and main controller at one side of CT scanner disk.
2. Placed the console on the operation desk in the control room.

Injection arm and Main

controller

Console
Location of Zenith-C11/C22 Parts

6-8 User’s Manual

6.2.2 Locating Parts of Zenith-C20
1. Placed the injector arm at one side of CT scanner disk.
2. Placed the console and main controller on the operation desk in the control room.

Location of Zenith-C20 Parts

User’s Manual 6-9

6.3 Connecting External Cables
6.3.1 Connecting Zenith-C11/C22 External Cables
Zenith-C11/C22 system cables connecting to different parts include the console cable, hand
switch cable, and power cable. Lay the console cable along with CT scanner cable path
through the wall between the scanning room and the control room.

System Cable Connection of Zenith-C11/C22

1. Connect the console cables

a) Connect one end of the console cable to ARM connector located on the rear of the
console. Tighten the cable screw to connect the connector well.
b) Connect the ground lead to the earthing rod.
c) Connect the hand switch terminal to H.SW connector located on the rear of the
console.

2. Connect the main controller cables

a) Connect one end of the console cable to ARM connector at the interface of the main
controller. Tighten the cable screw to connect the connector well.
b) Connect the ground lead to the earthing rod.
c) Confirm the power switch of the main controller being at OFF position and plug the cord
of the power cables from the main controller into an AC outlet.

The console and power cables should be fastened using nylon line at cable
fastener on the main controller foot.

3. Connect the heater cable

6-10 User’s Manual

User’s Manual
6-11
6.3.2 Connecting Zenith-C20 External Cables
Zenith-C20 system cables connecting to different parts include the console cable, arm
cable, switch cable, and power cable.
Lay the arm cable along with CT scanner cable path through the wall between the
scanning room and the control room.

1. Connect injector arm cable

Connect one end of the arm cable to ARM connector located on the bottom of the injector
arm. Tighten the cable screw to connect the connector well.
The arm cable should be fasted at the cable clamp located with the tray.
2. Install the main controller cable
a) Connect one end of the arm cable to ARM connector located on the rear of the console.
Tighten the cable screw to connect the connector well.
b) Connect one end of console cable to the CONSOLE 1 connector located on the rear of
the console and fasten the set screw of cable plug.
c) Confirm the power switch being at the OFF position. Connect the power cord to the rear
of the main controller, then plug the cord into an AC outlet.
3. Installation of console cable
a) Connect one end of the console cable to ARM connector located on the rear of the
console. Tighten the cable screw to connect the connector well.
b) Connect the hand switch terminal to H.SW connector located on the rear of the
console.
3. Installation of heater cable

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User’s Manual
6-13
7 Maintenance
The maintenance of the system is extremely important. The user should properly handle
routine maintenance, cleaning, and monthly inspection. The authorized technicians should
do preventive maintenance at least once in a year. The preventive maintenance schedule and
service procedures are in the Service Manual.
Only the disposables contact directly the patients’ blood path. There are not any
components of the device that directly or indirectly contact the patients’ blood path. All parts
of the device are reusable for multiple patients. Clean the system outside the sterile field.

The system's power must be disconnected when cleaning any

component. There is risk of electric shock when cleaning with
the power on.
Do not use an overly wet cloth to clean the system. Water
droplets accessing the internal components can damage the
system.
The cleaned components must be confirmed to be dry before
plugging in the power and giving power to the system.

7.1 Routine Maintenance

Each day when in use, it is necessary to promptly clean away residual contrast media. The
product is not a waterproof apparatus. If medicinal liquid is accidentally spilled, use a moist
towel to wipe away residual contrast media on the injection SyringeⅠinstallation frame,
piston rod, bend pipe, tray, and base.
If contrast media is found to have permeated the internals of the system, it is necessary to
promptly open the exterior case and wipe clean. This work may only be completed by an
authorized technician. Please promptly contact the manufacturer or your distributor.

7.2 Monthly Inspection

A complete inspection and cleaning is recommended for the system every three months.
The goal of the inspection is to uncover potential system malfunctions and safety incidents.
Items to check: Is there damage to exterior wiring, are plugs loose, is the system ground
reliable, and are any casings cracked. During inspection, clean dust from all components.
Before cleaning, power must be shut off and the power plug must be unplugged. Use a warm
cloth to wipe dust from the machine frame, main controller, and console.

User’s Manual 7-1

7.3 Annual Maintenance
It is recommended that the manufacturer conduct a complete inspection and calibration of
the system once every year. Manufacturer authorized technicians will carry out inspection
and cleaning of the system's mechanical components and sensors, focusing on removal of
residual contrast media in the system . Please contact Seacrown or your dealer to do annual
maintenance.

7.4 Cleaning
Using a soft non-abrasive cloth, warm water, and a mild disinfectant, carefully clean the
assembly, paying particular attention to the piston rod and the syringe chuck.
Do not use alcohol-based detergents. The water should not contain the following
substances, even in trace amounts:
•esters
•ethers
•ketones
•chlorides
•n-Alkyl
•alcohols (other than ethyl alcohol)
•cleaners and disinfectants (such as SaniZide and TB-Cide Quat)
•products containing: dimethyl benzyl, ammonium chlorides, and dimethyl ethylbenzyl

7.4.1 Cleaning Injector Arm

To clean the injector arm:
Uninstall the syringe from the injector arm.
Fully advance the piston rod by pressing [Forward ] button.
Place the injector arm in a vertical position.
Clean the piston rod with a soft cloth or paper towel dampened with cleaning solution.
Clean the inner area of the syringe chuck with a soft cloth, paper towel or cotton-tipped
applicator dampened with cleaning solution or warm water.
Wipe the injector arm cover with a soft cloth or paper towel dampened with cleaning
solution or warm water.
Thoroughly dry the injector arm cover with a paper towel.

To clean harden contrast in the syringe chuck:

Place the injector arm in a vertical position.
The entire syringe chucks may be placed or soaked in warm water for ten minutes.
Thoroughly dry the syringe chucks with a paper towel.
.

7-2 User’s Manual

7.4.2 Cleaning Console
The console may be dusted by using a lint-free cloth. To clean the touch screen, use a
nonabrasive cloth towel and any commercially available non-ammonia window cleaner to
regularly clean the surface. The cleaning solution should be applied to the towel rather than
the surface of the touch screen. The touch screen has air vents and is not designed with
water tight bezels so fluid ingress may occur from behind the panel if not cleaned carefully.

Do not use solvent cleaners to clean the apparatus.

Do not directly spray cleaner onto the touch-screen.

7.4.3 Cleaning Main Controller

Clean the exterior of the main controller by spraying a cloth with an all-purpose household
cleaner, then gently wipe clean.

User’s Manual 7-3

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7-4 User’s Manual

8 Messages
The console screen displays system messages when system malfunction, or injection
terminated abnormally, or incorrect input. The system messages fall into two categories:
Error Codes — The right corner of the console displays a unique error code for the service
staffs to categorize the problem. Details of the error codes could be read in service manual.
User Error Messages — Those messages that appear in response to incorrect user input or
to inform the user of the status of the system.
This chapter contains instructions on responding to notice messages. Messages are
displayed on the console screen in response to incorrect user input or action and equipment
status.

8.1 Injector Ready Messages

Message: Before click the [Ready] icon, press [Expel Air] buttons to expel air from the
syringe and fluid path.

Occur when: Click [Ready] icon when not pressing both [Expel Air] buttons on the
injector arm.
Action: Press both [Expel Air] buttons and then make the system Ready.

User’s Manual 8-1

8.2 Injection Messages
Message: The injection pressure is over limit value. Check the protocol parameters and
fluid path.

Occur when: Programmed an unreasonable protocol, or set low pressure limit, or use
incompetent disposables.
Action: Modify the protocol flow rate or the pressure limit. Verify to use qualified
disposables.

Message: The injection pressure changed sharply. Check the patient connection and
disposables.

Occur when: Mostly extravasation or disconnect of disposables happened.

Action: Check patient puncture and tube connection.

8-2 User’s Manual

8.3 Protocol Messages
Message: Total Volume can’t be more than the volume remaining in the syringe.

Occur when: Programed a unreasonable protocol.

Action: Decrease the Total Volume or fill more fluid to the syringe.

Message: The selected protocol will be deleted and can’t be recovered after clicking the
[OK] icon.

Occur when: Delete a stored protocol.

User action: None.

Message: Reduplicative protocol name. Click [OK] icon to modify the protocol or click
[Cancel ] icon to cancel.

Occur when: Input reduplicative protocol name.

Action: Rename the protocol or update the stored protocol.

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8-4 User’s Manual

9 EMC Information
This medical device manufactured by Seacrown conforms to this IEC60601-1-2:2014
standard for both immunity and emissions.
Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

The system is intended for use in the electromagnetic environment specified below. The
customer or the user of the system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
Mains Terminal The system uses RF energy only for its internal
Disturbance Voltage Group1 function. Therefore, its RF emissions are very low
(Conducted Class A and are not likely to cause any interference in
Emission) nearby electronic equipment.

CISPR 11

Electromagnetic The system is suitable for use in all

Radiation Group1 establishments, including domestic
Disturbance Class A establishments and those directly connected to the
(Radiated Emission) public low-voltage power supply network that
supplies buildings used for domestic purposes..
CISPR 11
Harmonic emissions N/A

IEC 61000-3-2
Voltage fluctuations
/ flicker emissions N/A

IEC 61000-3-3

User’s Manual 9-1

Table 2

Guidance and manufacturer’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below. The
customer or the user of the system should assure that it is used in such an environment.
Immunity IEC 60601 Compliance Electromagnetic environment –
test test level level guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or
discharge ±15 kV air ±15 kV air ceramic tile. If floors are covered
(ESD) with synthetic material, the
relative humidity should be at least
IEC 61000-4-2 30 %.
Electrostatic ±2 kV for ±2 kV for power Mains power quality should be that
transient/burs power supply lines of the professional healthcare
t supply lines facility environment
±1 kV for ± 1 kV for
IEC 61000-4-4 input/output, input/output,
Signal lines Signal lines
Surge ±1 kV ±1 kV differential Mains power quality should be that
differential mode of the professional healthcare
IEC 61000-4-5 mode ±2 kV common facility environment.
±2 kV common mode
mode
Voltage dips, <5 % UT <5 % UT Mains power quality should be that
short (>95 % dip in (>95 % dip in UT) of the professional healthcare
interruptions UT) for 0,5 cycle facility environment. If the user of
and for 0,5 cycle the system requires continued
voltage 40 % UT operation during power mains
variations 40 % UT (60 % dip in UT) interruptions, it is recommended
on power (60 % dip in for 5 cycles that the system be powered from an
supply UT) uninterruptible power supply.
input lines for 5 cycles 70 % UT
(30 % dip in UT)
IEC 70 % UT for 30 cycles
61000-4-11 (30 % dip in
UT) <5 % UT
for 30 cycles (>95 % dip in UT)
for 300 cycles
<5 % UT
(>95 % dip in
UT)
for 300 cycles
Power 30A/m 30A/m Power frequency magnetic fields
frequency should be at levels characteristic of
(50/60 Hz) a typical location in the
magnetic field professional healthcare facility
environment.
IEC 61000-4-8
NOTEUT is the a.c. mains voltage prior to application of the test level.

9-2 User’s Manual

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an
environment.
Immunity IEC 60601 Compliance Electromagnetic environment – guidance
test test level level
Portable and mobile RF communications
Conducted 3 Vrms 3V equipment should be used no closer to any part
RF 150 kHz to of the system including cables, than the
IEC 80 MHz recommended separation distance calculated
61000-4-6 from the equation applicable to the frequency
of the transmitter.

Radiated 3 V/m 3 V/m

RF 80 MHz to
IEC 2,7 GHz
61000-4-3

Immunity 0.3m 0.3m

to Distance Distance
Proximity
Fields from See Table 9 See Table 9
RF for test for test level
Wireless level
Communic
ations
Equipment
IEC
61000-4-3

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the system is used
exceeds the applicable RF compliance level above, the system should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the system.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.

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9-4 User’s Manual

10 Index
A F
Annual maintenance 7-2 Features 1-8
Assembling Parts 6-1 Fill Syringe 4-5
Attaching Tubing to syringes 4-7 Filling Syringe Automatically 4-6
Autofill 2-7 Filling Syringe Manually 4-6
Autofill Button 2-11 Flow Rate 2-17
Fluid Delivery Performance 2-7
B Forward Button 2-11
Blous Tracking Injection 5-5
Bolus Tracking Parameter 2-28 H
Help Screen 2-36
C History Screen 2-35
Cleaning 7-2 Hold 2-18
Cleaning Console 7-3 Home Screen 2-15
Cleaning Injector arm 7-2
Cleaning Main controller 7-3 I
Contraindications 1-1 Indications for use 1-1
Controlling Injection 2-12 Injection Delay 2-17
Connecting to Patient 4-9 Injection Messages 8-2
Connecting Cables 6-10 Injector Arm 2-8
Console 2-13 Injector Ready Messages 8-1
Console Buttons 2-13 Installation 6-1
Console Display Screen 2-14
K
D KVO 2-15
Date and Time Setup 2-30 KVO Parameters Setup 2-27
Deciding on Injection Protocol 4-2
Disposables 1-9 L
Dimensions and weights 2-4 Locating Parts 6-8
Duration 2-16 Locating parts of Zenith-C11/C22 6-8
Locating parts of Zenit-C20 6-9
E Language Selection 2-29
Electrical Requirements 2-7
Electromagnetic compatibility 1-1
M
EMC Information 9-1
Main controller 2-37
Environmental 2-7
Maintenance 7-1
Expel Air Button 2-11
Maximum Flow Rate 1-8
Messages 8-1
P
Mode of Operation 1-1
Pause 2-18
Monthly Inspection 7-1
Pausing an Injection 5-9
Moving Piston Rod 2-11
Pressure Limit 2-17
Phase Attribute 2-18
O
Priming Tubing 4-9
Over and Under Injection Protection 1-8
Priming Tubing with Saline 4-9
Priming Tubing with Contrast 4-9
T
Product Identification 1-1
Test Button 2-12
Protection against electric shock 1-1
Test Injection 2-12
Protocol Injection 5-7
Terminating an Injecting 5-10
Protocol name 2-16
Total time 2-15
Protocol Messages 8-3
Total Volume 2-16
Protocol Screen 2-21
Turing the System Power On 3-1
Power On/Off 3-1
Turing the System Power Off 3-2
Purging Air from Syringe 4-8
User’s Manual 10-1
R U
Ready Button 2-12 User Qualification 1-1
Ready Injection 2-12
Readying System 4-10 V
Readying Sequence 4-1 Volume Display 2-12
Recalling Protocol 4-3
Removing Syringe 5-11 W
Restarting an Injection 5-10 Warnings 1-4
Reviewing Parameters 5-2 Weight 2-4
Routine maintenance 7-1
Running KVO Injection 5-4

S
Scan delay 2-17
Specifications 2-4
Store Protocol 2-21
Stop Button 2-11
Symbols 1-2
System Installation 6-1
System Overview 2-1
System Response to Occlusions 1-8
System Status 2-12
System Setup and Test Screen 2-25

10-2 User’s Manual