The information contained in this document is subject to change without notice.
This document contains proprietary information that is protected by copyright. All rights
are reserved. No part of this document may be reproduced,translated to another language
or stored in a retrieval system, or transmitted by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission. Windows is a registered
trademark of Microsoft, Inc. Other brand or product names are trademarks of their respective
holders.
Caution!
Any changes or modications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Warnings and Cautions
Please read this manual and follow its instructions carefully. The words warning, caution, and
note carry special meanings and should be carefully reviewed:
Warning The personal safety of the patient or physician may be involved.
Disregarding this information could result in injury to the patient or
physician.
Caution Special service procedures or precautions must be followed to avoid
damaging the instrument.
NoteSpecial information to make maintenance easier or important information
more clear.
A lightning bolt within a triangle is intended to warn of the presence of
hazardous voltage. Refer all service to authorized personnel.
Warranty is void if any of these warnings are disregarded.
ADVAN Int’l Corp accepts full responsibility for the effects on safety, reliability, and
performance of the equipment only if:
Re-adjustments, modications, and/or repairs are carried out exclusively by ADVAN Int’l
‧
Corp.
The electrical installation of the relevant operating room complies with the applicable IEC
‧
and CE requirements.
Warning Federal law (United States of America) restricts this device to use by,
or on order of a physician.
ADVAN Int’l Corp's AMM215WTTP monitor has been tested under ANSI/AAMI ES60601-1
standard for Medical application.
ADVAN Int’l Corp reserves the right to make improvements in the product(s) described
herein. Product(s), therefore, may not agree in detail to the published design or
specications. All specications are subject to change without notice.
Please use rear cover page with ADVAN contact points or phone your local ADVAN Int’l Corp
sales representative or agent for information on changes and new products.
1
Warnings
Warning TO AVOID POTENTIAL SERIOUS INJURY TO THE USER AND THE
PATIENT AND/OR DAMAGE TO THIS DEVICE, THE USER MUST :
1. Read the operating manual thoroughly and be familiar with its contents prior to using this
equipment.
2. Carefully unpack the unit and check if any damage occurred during shipment.
3. Should any solid object or liquid fall into the panel, unplug the unit and have it checked
by qualied personnel before operating it any further.
4. Uplug the unit if it is not to be used for an extended period of time. To disconnect the
cord, pull it out by the plug. Never pull the cord itself.
5. Be a qualied physician, having complete knowledge of the use of this equipment.
6. Test this equipment prior to a medical procedure. This monitor was fully tested at the
factory before shipment.
7. Avoid removing covers on control unit to avoid electric shock.
8. Attempt no internal repairs or adjustments not specically detailed in this operating
manual.
9. Pay close attention to the care, cleaning instructions in this manual. A deviation may
cause damage (refer to the Cleaning section).
10. DO NOT STERILIZE MONITOR.
11. Read the entire instruction manual before assembling or connecting the camera.
12. Do not place the monitor or any other heavy object on the power cord. Damage to the
cable can cause re or electirc shock.
13. Monitor with power supply is suitable for use in patient environment.
14. DO NOT stack more than "6" boxes high.
15. To avoid risk of electric shock, this equipment must only be connected to supply mains
with protective earth.
16. Do not modify this equipment without authorization of the manufacturer.
17. Power cord is used as a disconnection device. To de-energize equipment, disconnect the
power cord. ME Equipment should be placed easily powered off place.
This equipment has been tested and found to comply with the limits for medical devices in
IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
NOTICES TO USER
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
2
Cautions
1. The AC Adapter must be plugged into a grounded power outlet.
2. Use only the proprietary AMM215WTTP power supply for the AMM215WTTP monitor.
3. Turn power off when unit is not in use. Disconnect the power plug from AC outlet if the
product is not going to be used for an extended period of time.
4. Never operate the unit right after having transported from a cold location directly to a
warm location.
5. Do not expose the monitor to moisture or directly apply liquid cleaners directly to the
screen. Spray the cleaning solution into a soft cloth and clean gently.
6. Handle the monitor with care. Do not strike or scratch the screen.
7. Do not block the monitor cooling vents. The monitor is cooled by natural convection and
has no fan.
8. Do not force the monitor past 28 degrees of vertical when adjusting the screen position.
(For monitors equipped with stands only.)
9. Remove the power module and connection when transporting the unit.
10. Save the original carton and associated packing material. They will be useful should you
have to transport or ship the unit.
11. Allow adequate air circulation to prevent internal heat buildup.
12. Do not place the unit on surfaces (rugs, blankets, etc.) or near materials (curtains, draperies) that may block the ventilation slots.
13. Do not install the unit near sunlight, excessive dust, mechanical vibration or shock.
14. The unit is designed for operation in a horizontal position. Never operate the unit in a
vertical position.
15. Keep the unit away from equipment with strong magnets (i.e. a large loudspeaker.)
16. Equipment with SIP/SOP connectors should either comply with IEC 60601-1 and/or
IEC 60601-1-1 harmonized national standard or the combination should be evaluated.
Do not touch the patient with signal input or output connectors.
17. Use only a hospital grade power supply cord.
18. This equipment has been tested and found to comply with the limit for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable generate uses and can radiate radio frequency energy, if not installed and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in
a particular installation, which can be detemined by turning the equipment off and on, the
user is encourage to try to correct the interference by one or more of the following
measures:
‧
‧
‧
other device(s) are connected.
‧
19. Grounding reliability can only be achieved when the equipment is connected to an equipment receptacle labeled “Hospital Only” or “Hospital Grade.”
Reorient or relocate the receiving device.
Increase the separation distance between the equipment.
Connect the equipment to an outlet on a circuit different from that to which the
Consult the manufacturer or eld service technican for help.
CautionTo connect to an international power supply, use a an attachment plug
appropriate for the power outlet.
Caution Refer to the “Electromagnetic Compatibility” (EMC) section of this manual
to ensure EMC. The AMM215WTTP must be installed and operated according to the EMC information provided in this manual.
3
Symbol Denitions
E472062
General warning sign
of risk of danger
Dangerous: High Voltage
For indoor use only.
Tested to comply with FCC
Class B standards.
Direct Current
DC power control switch
Serial Number
This way up
Medical Equipment
With respect to electric shock,
re and mechanical hazards
only in accordance with
Fragile, handle with care
AAMI ES60601-1(2005/(R)2012
6
Stacking limit by number
NO. 60601-1:14 Edition 3 Revision Date 2014.01.01
Keep dry
Tested to comply with IP
Recyclable
Indicates proof of conformity
to applicable European
"Economic Community Council"
WEEE symbol for the recyclable product. Please do
not throw the product with this
symbol in the bin.
directives and to harmonized
standards published in the
ofcial journal of the European
Consult instructions for use
Communities.
51LJ
+ A1:2012, C1:2009/(R)2012 +
A2:2010/(R)2012), and CSA-C22.2
IPX1
(ingression protection) Rating
ANSI/
Authorized Representative in
Europe
Date of Manufacture
Manufacturer
4
EU Declaration of Conformity for Medical Applications
A Declaration of Conformity has been led for this product. A sample of this document may
be found in the addendum which accompanied this manual. For a copy of the Declaration
of Conformity document, please contact ADVAN Int’l Corp. and request for AMM215WTTP
DOC.
Cleaning Your Monitor
Turn off the product before cleaning. No specic liquid or chemical is necessary when
cleaning this LCD monitor. However, it is suggested to use a soft cloth moistened with mild
detergent to clean the display housing.
To clean the screen, do not spray liquid cleaners directly on to the unit. Spray cleaning
solution onto a cloth, and without applying excessive pressure, clean the screen.
Caution: Do not use abrasive cleaners, waxes or solvents for your cleaning.
5
This monitor is intended for use in Health Care Facilities Model AMM215WTTP Equipment is
not suitable for use in the presence of ammable anesthetic mixture with air or with oxygen
or nitrous oxide.
No user serviceable parts inside, ask qualied personnel when accessing inside.
This product contains electrical waste or electronic equipment. It must not be disposed of as
unsorted municipal waste and must be collected separately.
Electrical input rating: 12V DC 3A
Classication
Type of protection against electric shock: Class I Equipment.
Degree of protection against the ingress of water: IPX1 compliance.
Mode of operation: Continuous
This monitor has been tested to comply with IEC/EN 60601-1, IEC/EN60601-1-2 and is
certied by UL to medical standard(UL/cUL Mark).
Because many medical ofces are located in residential areas, this monitor, in addition to the
medical requirements, has also been tested and found to comply with
the limits for FCC Class B computing devices in a typically congured system. It is the
system integrator or congurer’s responsibility to test and ensure that the entire
system complies with applicable EMC laws.
Environmental conditions for transport and storage:
- Temperature range within -4° to 140° F (-20° to 60°C)
- Relative humidity range within 10% to 90%
- Atmospheric pressure range within 500 to 1060 hPa.
- Operating within 0° to 40°C
Environmental conditions for operating:
- Operating temperature range within 32° to 104° F (0° to 40°C)
6
Electromagnetic Compatibility
Like other electrical medical equipment, the AMM215WTTP requires special precautions to
ensure electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC), the AMM215WTTP must be installed and operated
according to the EMC information provided in this manual.
NoteThe AMM215WTTP has been designed and tested to comply with EN 60601-1-2 requirements for EMC with other devices.
Caution Portable and mobile RF communications equipment may affect the
normal function of the AMM215WTTP.
Warning Do not use cables or accessories other than those provided with
the AMM215WTTP, as this may result in increased electromagnetic emissions
or decreased immunity to such emissions.
Warning If the AMM215WTTP is used adjacent to or stacked with other equipment, observe and verify normal operation of the AMM215WTTP in the
conguration in which it will be used prior to using it in a surgical procedure.
Consult the tables below for guidance in placing the AMM215WTTP.
The Model AMM215WTTP is intended for use in the electromagnetic environment specied below.
The user of AMM215WTTP should assure that it is used in such an environment.
Emission test ComplianceElectromagnetic Environment - Guidance
The Model AMM215WTTP uses RF energy only for its internal
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions
IEC61000-3-2
Voltage Fluctuations
IEC61000-3-3
Class D
Complies
function. Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment
AMM215WTTP is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes
The Model AMM215WTTP is intended for use in the electromagnetic environment specied below.
The user of AMM215WTTP should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electrostatic discharge
(ESD)
IEC61000-4-2
Electrical fast transient
/burst IEC61000-4-4
Surge
IEC61000-4-5
6 kV contact
8 kV air
2 kV for power supply lines
1 kV for input / output lines
1 kV differential mode
2 kV common mode
6 kV contact
8 kV air
2 kV for power supply lines
1 kV for input / output lines
1 kV differential mode
2 kV common mode
7
Electromagnetic
Environment - Guidance
Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relativehumidity should be
at least 30%.
Mains power quality
should be that of a typical
commercial or hospital
environment
Mains power quality
should be that of a typical
commercial or
hospital environment.
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