© MEDISTIM 2015
3
1. INTRODUCTION
1.1 Purpose
The purpose of this User Manual is to give a thorough de-
scription of the Medistim VeriQ™ System.
1.2 Contact information
Medistim ASA
Head Office:
Økernveien 94
0579 Oslo, Norway
Telephone: +47 23 05 96 60
Fax:+47 23 05 96 61
E-mail: [email protected]
Internet: http://www.Medistim.com
Manufacturing and Service support:
Moloveien 10,
3187 Horten, Norway
Telephone: +47 33 03 17 10
Fax: +47 33 03 17 26
E-mail: [email protected]
1.3 User Manual structure and use
1.3.1
Relevant books and documents
Please refer to the following relevant information in addition
to this User Manual:
• www.medistim.com
•
Service Manual for VeriQ™p/n: VQ1980GB
•
Intraoperative Graft Patency Verification during On- and
Off- Pump Coronary Bypass Surgery” by Hratch L. Kara-
manoukian, MD and Harry W. Donias, M.D.,Medistim ref.
number MM117803
•
Intraoperative Graft Patency Verification in Cardiac and
Vascular Surgery”. ISBN# 0-87993-488-3s
1.3.2
User Manual Update
In the incidence of additional modifications to the VeriQ™,
a new revision of the Medistim VeriQ™ User Manual will be
distributed by Medistim ASA.
1.4 Warning statements and safety markings
1.4.1
User Manual warning statements
This User Manual uses Warnings and Notes according to the
following definitions:
Warning
This warning will describe clinical contraindications and
possible damage to the device if the recommended instruc-
tions or recommendations are not followed. Please read and
follow these warnings carefully. If Warnings are not taken
into consideration, serious injury and damage to personnel,
devices and the operating environment can occur. The man-
ufacturer cannot be held liable for injury or damage if these
precautions are disregarded.
Note
A Note contains important tips, recommendations and sup-
plementary information intended to optimize the use of the
system.
1.4.2
User Manual language options
The User Manual is, upon request, available in English,
French, Spanish, Swedish, Danish, Norwegian, German and
Italian.
1.5 Safety marking description
On / Off button (push-push)
Attention, consult accompanying documents
Protective earth (ground)
Terminal for Potential Equalization
Consult accompanying documents
(Required to consult for safety)
Pushing prohibited
Warning
Medical electrical equipment needs special precautions
regarding electromagnetic compatibility (EMC) and needs
to be installed and put into service according to the instruc-
tions provided in this manual. Portable and mobile radio fre-
quency (rf) communications equipment can affect medical
electrical equipment. No connection from the internal signal
input/outputs located at the lower side of the electronic
unit to external equipment are allowed. For DICOM enabled
systems, the network connection marked with IEC60601-1
compliance are excepted from this.
Warning
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth
Warning
Equipment connected to the systems signal input/ output
shall comply with iec 60601-1 clause 16
Potential Equalization conductor
A terminal for potential equalization is located at the back
of the power unit of the system. The terminal can be used if
potential equalization needed but is no replacement for the
protective earth conductor of the power chord as required
by IEC60601-1 cl. 8.6.7.