ACIST CVi Installation and operating instructions

Bracco Group
ACIST CVi Contrast Delivery System (including CMS2000 and E2000 Voyager)
User Manual Addendum
901082-001, 03 2012-08

Page ii | ACIST CVi Contrast Delivery System User Manual Addendum 901082-001,03 ENG 2012-08
Proprietary Information Notice
This document contains information proprietary to ACIST Medical Systems, Inc. All rights reserved.
Protected by one or more of the following U.S. patents and international counterparts: 5,515,851; 5,573,515;
5,800,397; 5,916,165; 5,988,587; 6,099,502; 6,221,045; 6,344,030; 6,447,481; 6,626,862; 6,656,157; 6,673,048;
6,746,427; 6,752,789; 6,945,959; 7,101,352; 7,128,729; 7,153,288; 7,169,135;7,267,666;7,357,785;7,389,788;
D404,717. Other U.S. and international patents pending.
No part of this document may be reproduced, transmitted, processed, or recorded by any means or form,
electronic, mechanical, photographic or otherwise, nor be released to any third party without the written
consent of ACIST Medical Systems, Inc.
Copyright © 2010,2011, 2012 ACIST Medical Systems, Inc. All rights reserved.
The written and graphic product descriptions in this manual were eective at the time of printing. ACIST
Medical Systems, Inc. reserves the right to change specications and designs without prior notication.
ACIST, ACIST | CVi, and AngioTouch are registered trademarks of ACIST Medical Systems, Inc. LogiCal, SURE-CAL
and Smiths are registered trademarks of Smiths Group PLC.
Contact Information
USA ACIST Medical Systems, Inc.
7905 Fuller Road
Eden Prairie, MN 55344 USA
Technical Services: 1-888-670-7701
or 952-941-3507
FAX: [phone]
E-Mail: Customer.Suppor[email protected]
Europe: ACIST Europe BV
II Fiore Building
Renier Nafzgerstraat 114
6221 KL Maastricht
The Netherlands
Technical Services: + 800 22478 387
or [phone]
FAX: [phone]
Asia ACIST Asia Pte Ltd.
133 New Bridge Road
#20-06/07/08 Chinatown Point
Singapore 059413
Technical Services: + 65 6533 6630
FAX: [phone]

ACIST CVi Contrast Delivery System User Manual Addendum | Page iii901082-001,03 ENG 2012-08
Contents
Proprietary Information Notice. . . . . . . . . . . . . . . . . . . ii
Contact Information . . . . . . . . . . . . . . . . . . . . . . . ii
1 Introduction 1
Purpose of this Addendum . . . . . . . . . . . . . . . . . . . . . . 1
2 Additional Warnings and Symbol Denitions 3
AdditionalWarnings . . . . . . . . . . . . . . . . . . . . . . . . . 3
Graphical Symbol Denitions . . . . . . . . . . . . . . . . . . . . . 3
3 Saline Pump Setup and Adjustment 7
How to Adjust the Tubing Guides on the Saline Pump . . . . . . . . . . 7
4 Universal Power Supply 9
Optional Universal Power Supply Unit . . . . . . . . . . . . . . . . . 9
Power Supply Specications . . . . . . . . . . . . . . . . . . . . . 9
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . 9
Electrical Leakage . . . . . . . . . . . . . . . . . . . . . . . . 9
Setup Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Power Supply to Injector Head Power Cable Connection . . . . . . .10
Power Supply to Siemens Scanner Connection. . . . . . . . . . . . 10
Power Supply to Mains Power Connection. . . . . . . . . . . . . . 11
Power Supply Equipotential Cable Connection . . . . . . . . . . . . 11
5 Pedestal Cart 13
Pedestal Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Pedestal Cart Specications. . . . . . . . . . . . . . . . . . . . . . 13
How to Mount the Power Supply on the Pedestal Cart . . . . . . . . . . 14
How toTransfer the Injector Head to/from the Pedestal Cart . . . . . . . 15
6 Injection Parameter Ranges and Accuracies 17
7 Supported Imaging Systems 19
8 Hemodynamic Transducer Specications 21
9 EMC Tables 23

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ACIST CVi Contrast Delivery System User Manual Addendum | Page 1901082-001,03 ENG 2012-08
Introduction
1 Introduction
e purpose of this addendum for the ACIST CVi User Manual (900468) is
to provide updated information regarding:
• additional warnings and symbol denitions
• adjusting the tubing guides on the saline pump,
• an optional Universal Power Supply unit,
• an optional Pedestal Cart,
• injection parameter ranges and accuracies,
• supported imaging systems,
• hemodynamic transducer specications, and
• electromagnetic environment specications as provided in EMC tables.
Purpose
of this
Addendum

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Introduction
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ACIST CVi Contrast Delivery System User Manual Addendum | Page 3901082-001,03 ENG 2012-08
Additional Warnings and Symbol Denitions
2 Additional Warnings and
Symbol Denitions
Additional
Warnings
e following additional warnings refer to hazards that can cause serious
injury or death:
• No modication of this equipment is allowed.
• To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
• e ACIST CVi Contrast Delivery System may only be interfaced with
X-Ray equipment certied IEC 60601-1 2nd or 3rd edition.
• Do not touch the patient while making connections to the injector head
or to the power supply.
• In order to avoid the potential for electric shock to the patient, do not
touch the patient and the X-ray interface connector pins simultaneously.
• In order to avoid the potential for electric shock to the patient, the X-ray
equipment used in conjuction with the ACIST CVi Injector must provide
two means of patient protection.
• In order to meet the debrillator protection specied, the customer must
use ACIST-specied accessories including transducers and adaptor cables.
Symbol Denition
Patient Applied Part, Degree of protection against
electric shock, Type CF debrillation proof
Alternating current.
Equipotentiality
Pushing prohibited
Consult instructions for use.
Graphical
Symbol
Denitions

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Additional Warnings and Symbol Denitions
Symbol Denition
Do not re-use
Keep dry
Manufacturer.
Date of manufacture.
Serial number.
Catalog number.
CAUTION: Federal law (USA) restricts this device
to sale, distribution, and use by, or on the order of, a
physician.
Dangerous voltage.
Explosion hazard.
Do not tip
European representative.
Contact for service
Graphical
Symbol
Denitions
(continued)

ACIST CVi Contrast Delivery System User Manual Addendum | Page 5901082-001,03 ENG 2012-08
Additional Warnings and Symbol Denitions
Graphical
Symbol
Denitions
(continued)
Symbol Denition
This product should be recycled and not disposed of
as general waste (subject to WEEE annex IV resp.
EN 50419).
In accordance with European Union WEEE
Directive 2002/96/EC, ACIST Europe BV will be fully
responsible for the coordination, logistics, and costs
of the WEEE process.
With respect to electric shock, re, mechanical and
other specied hazards, only in accordance with IEC
60601-1, second and third editions.
Compliance, European directive 93/42/EEC. Medical
Device Directive.
Fragile, handle with care.
Sterilized using ethylene oxide.
IP
21
Environmental enclosure rating, protected against
objects greater than 12 mm and protected against
dripping water, Injector Head.
General warning sign.

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Additional Warnings and Symbol Denitions
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