Information in this document has been carefully checked for accuracy; however,
no guarantee is given to the correctness of the contents. This document is subject
to change without notice. Planar provides this information as reference only.
Reference to other vendors’ product does not impl y any recommendati o n or
endorsement.
This document contains pro p rietary informa tion protected by copyright. No part of
this manual may be reproduced by any mechanical, electronic, or other means, in
any form, without prior written permission of the manufacturer.
Planar and VitalScreen are re gistered trademar ks of Planar Systems, Inc.
DOCUMENT HISTORY
DATEDESCRIPTION
April 2002 020-0168-00A
January 2003 020-0168-00B
Regulatory Compliance
VitalScreen CSR
This display has been tested and found to comply with IEC/EN 606 01 - 1
and IEC/EN 60601-1-2 standards, and is certified to meet medical
standard C22.2 No. 601.1-M1990 (C US Mark).
The medical display, in addition to meeting medical requirements,
has been tested and found to comply with the limits for Federal
Communications Commission ( FCC) Class B computing devices in
a typically configured system since many medical offices are located in
residential areas. It is the system integrator’s re sponsibility to test and
ensure that the entire system complies wi th applicable electromagnetic
compatibility (EMC) laws.
Planar Systems, Inc. has made great efforts to support the medical
device industry, in particular, medical device manufacturers and medical
device system integrators. We offer state-of-the-art color displays that are
compliant with worldwide accepted medical device safety standards, and
for the European market, CE-marked displays based on compliance with
counsel directive 93/42/EEC—commonly referred to as the Medical Device
Directive (MDD). The following summarizes our qualification of these
displays as it relates to compliance with the MDD.
iii
The European Medical Device Directive requires that the intended use
of the device be defined. The intended use of these displays is “to display
alphanumeric, graphic, and image data as inputted from any type of
medical device.” These displays do not provide a measurement function
in any way, and it is the device and systems manufactur er’s responsibility
to verify its function in the integrated device or system.
The display was classified as required by the MDD according to Annex IX
of the directive and the medical device (MEDDEV) guidance available
at the time of classification. Because the display uses electrical energy
and has no direct patient connections andby itselfno medical utility,
the display is classified according to Rule 12 as an MDD Class I devicecomponent or ac c e s s o ry. The MDD stat es t h a t m anufa c tu r ers of Cla s s I
medical devices or acces sories shall satisfy the r equirements in regard
to design and manufacturing controls, that is, the applicable assessment
route to be used for CE-marking under the MDD, and it shall carry
the CE mark according to Annex XII of the directive, with no notified
body annotation.
The applicable safety standards for an MDD Class I display are
IEC/EN 60601-1:1900 along with Amendments 1 and 2. To help the
medical device designer evaluate the suitability of these displays,
Planar has also conducted EMC testing to I EC 60601-1-2 a s it can
be applied. The display with its power supply alone does not represent
a functional medical device. Hence, Planar configured a minimal
operating system to exercise the display. The resulting data are
made available to interested parti es.
The data are informative data, not certification data. Certification
data must be o btain ed by the device or system integrator according
to Article 12 of the MDD titled “Particular procedure for systems and
procedure packs.” Paragraph 2 clearly outli nes the device or system
integrator’s respons ibility in this matter.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
iv
In summary, Planar Systems, Inc. is CE-marking these di splays
under the Medical Device Directive, which establishes compliance to
the basic medical safety standards. However, EMC compliance can
only be accomplishe d in the configur ed medical devic e or syst em and
is the responsibility of the device or system manufacturer. Planar has
the necessary documentation such as IEC 60601-1 notified body and
other third-party test reports and certifications, a risk/hazard analysis,
an essential requ irements checklist, and the Planar International
Electrotechnical Commission (IEC) declaration of co nformity.
Planar Systems, Inc., located in Beaverton, Oregon, USA, is the
manufacturer of these displays in the meaning of the directive.
As required by the MDD in Article 14, Planar Systems, Inc., not
residing in the European Economic Area (EEA), has a European
representative, Planar Systems, Inc.Espoo, Finland.
In the opinion of Planar Systems, Inc. registration requir e d to put this
device into commerce is the responsibility of the medical device/system
manufacturer, and Planar sup ports this requirement by providin g a
European Commission (EC) declaration of conformity. If Planar supplies
a display to an end user, rather than a device manufacturer, it is the end
user’s responsibility to ensure continued compliance with the MDD of
the system in which the display is integrated.
For vigilance reporting as required under Article 10 of the MDD,
Planar Systems, Inc. will provide any information requested by
competent authority to support any reported incident investigation
by such an authority.
European Union Declaration of Conformity for Medical Applications
A Declaration of Conformity has been filed for this product. For
additional copies of the Declaration of Conformity document, contact
Planar Systems, Inc. and request document number 001-0014- 05
“Declaration of Conformity.”
VitalScreen CR
Manufacturer Dec laration
This certifies that this product is in compliance with the EU Directive
89/336/EEC, using the EMC standards EN55022 (class B), EN50081-1
and EN50082-1. This product meets or exceeds EN60950, UL1950, and
CSA 22.2 No. 950 safety requirements. This product has been tested and
verified to meet CISPR 22 Class B requirements.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
FCC Compliance Statement
This equipment has been tested and found to comply with the limits for
a Class B d igit al devi c e , pu rsuan t t o P a rt 15 of the FCC Ru l es. The s e
limits are designed to provide reas onable protection against har mful
interference when the equipment is operated in a residential installation.
This equipment generates, uses, and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment d oes ca use harmful interference to radio or
television reception, which can be determined by turning the equipment
off and on, you are en coura ged to try to co rrect the interference by one or
more of the followi ng measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment into an outlet different from that to whic h
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
v
To comply with the limits for an FCC Class B computing device,
always use the shielded signal cord and shielded power cord supplied
with this unit.
The Federal Communications Commission warns that changes or
modifications of the unit not expres sly approved by th e party responsible
for compliance could void the user’s authority to operate the eq uipment.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
Contents
vii
About This Manual ..............................................................ix
Description of Warranty.....................................................
Ordering Information .......... ................................................
20
23
25
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
ix
About This Manual
Congratulations on your purchase of the Vi talScreen display!
This operations manual will help you set up, use, and maintain
the VS17.4SXAD or CM17 . 4SX AD model prop erl y. Retain this
manual for future reference.
Read this section carefully to learn how to handle the display safely
and clean it correctly. It explains the symbols used on the products
and the conventions used in this manual.
Chapter 1 provides an overview of the VitalScreen display. It lists
the contents of the display package and identif i es th e co mponents of
the display.
Chapter 2 explains how to install the display correctly and use
optional components.
Chapter 3 explains the menus and function controls built into
the display.
Appendix A contains technical information.
Appendix B focuses on troubleshooting.
Warranty description and ordering information are provided at
the back of this manual.
Conventions
The VitalScreen display documentation uses these conventions.
This convention…
Indicates…
A warning that can prevent injury to you,
such as electric shock.
A note of important information regarding
a particular topic or procedure.
A caution that can prevent potential damage
to hardware or software
.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
x | Product Information
Product Information
Safety Instructions
Store the display in its original shipping carton when it is not in
operation for extended periods of time. Also use the original packing
materials and carton when shipping the display.
• Do not place the display near a window. Exposing the display to rain,
water, moisture, or constant direct sunlight can damage it.
Do not place anything on top of the display-to-computer signal cord.
•
Make sure the cord is placed where it will not be stepped on.
• Do not apply excessive pressure to the screen. Excessive pressu re
may cau s e permane n t d amage to th e displa y.
• Do not operate the touch screen with sharp object s, such as a scalpel .
Sharp objects can scratch or damage the touch screen. A damaged
touch screen may pose a safety hazard.
• Refer all servicing to qualified personnel to maintain your
warranty. The display and power supply units contain no
user-serviceable parts.
• Do not cover or obstruct the venting holes on the back of
the display.
• Store the display in an environment with a temperature
range from −20 to 65 degrees Celsius (from −4 to 149 degrees
Fahrenheit). Storing your display outside that temperature
range could result in permanent damage.
• Replace any cord or cable th at is frayed or damaged with
another of th e same type and rating as supplied by Planar.
(See “Ordering Information” at the end of this manual for part
numbers.) The safety and regulatory listings and certifications
are based on the cable supplied by Planar.
• Do not expose the display to liquid or drop it. If the case has been
damaged, the unit may pose a shock or fire hazard. Unplug the unit
immediately and c al l customer service for assistance.
• Use only the power adapter that has been test ed and approved
for use with this display product. (See “Ordering Information” for
part numbers.)
The power adapter must be plugged into a grounded power outlet.
• Use a cloth dampened with liquid cleaner to clean the power adapter.
Wipe the outside of the enclosure and c able on ly. Do not immerse the
adapter in liquid, or a safety hazard could arise during use.
• Do not use the pow e r adapter near i nflammable anesthetics.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
Product Information | xi
Cleaning Instructions
The VitalScreen display will continue to operate while being cleaned in
a fashion normal for a hospital environment. This means cleaning the
display with a damp, mild soapy cl oth.
The VitalScreen withstands nonabrasive cloths and cl eaning sol utions
used in hospital for like equipment. This cleaning typically includes warm
water and mild detergent for all surfaces or 70 percent isopropyl alcohol
for the touchscreen surface.
Possible cleaning solutions
• 70 percent isopropyl alcohol
• 1.6 percent aqueous ammonia
• Cidex
• Sodium hypochlorite (bleach) 10 percent
• “Green soap” United States Pharmacopoeia (USP)
• 0.5 percent Chlorhexidine in 70 percent isopropyl alcohol
• Ovation
• Formula 409
• Fantastic
•
(2.4 percent glutaraldehyde solution)
WexCide
To clean the screen
Stand away from the display and spray the cleaning solution onto
a clean nonabrasive cloth. Without applying excessive pressure, clean
the screen with the slightly dampened cloth. Dry the screen with
a clean nonabrasive cloth to remove any residue.
Do not spray liquid cleaners directly onto the screen.
Disposal Information
The VitalScreen display contains cold cathode fluorescent lamps, which
contain a maximum of 20 milligrams of mercury (5 milligrams per lamp).
Follow local ordinances or regulations for its disposal.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
xii | Product Information
Symbol Explanations
This table explains the symbols appearing on the display or power
supply adapter.
This symbol… Indicates…
Proof of conformity to applicabl e European Economic
Community Council direct i ves and two harmonized
standards published in th e official journal of the
European Communities.
The product has been tested to specific requirements of
medical or ITE device standards. If this mark appears with
the indicators “C” and “US,” the product is certifi ed for the
Canadian and U.S. markets, meeting the appl icable
Canadian and U.S. standards.
The product has been tested to com ply with
FCC Class B standards.
More information availabl e i n a ccompanying documents.
Protective earth ground.
The product has been tested to compl y wit h Underwriters’
Laboratories standards.
Indoor use only.
VS17.4SXAD / CM17.4SXAD
020-0168-00B)
(
Loading...
+ 28 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.