CYP MED-AS402 User manual

MED-AS402
Medical Video recorder
Operation Manual
Operation Manual

INSTRUCTIONS FOR THE USER
The document combines text and illustrations, providing a
comprehensive overview of the system. The information is presented
as a sequential series of actions, allowing the user to learn directly how
to use the device.
The text provides explanations and instructs the user step-by-step in
the practical use of the product, with short, clear instructions in an
easy-to-follow sequence.
DEFINITIONS
Warning! A WARNING statement provides important information
about a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Caution! A CAUTION statement provides important information
about a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the
user or patient or in damage to the equipment or other
property.
Note! A NOTE provides additional information intended to avoid
inconveniences during operation.

SAFETY INSTRUCTIONS
1. Strictly follow these Instructions for Use; please read these safety
instructions carefully.
2. Please keep this User Manual for later reference; any use of
the product requires full understanding and strict observation
of all portions of these instructions. Observe all WARNINGS and
CAUTIONS as rendered throughout this manual and on labels on
the equipment.
3. Repair of the device may only be carried out by trained service
personnel. Recommends that a service contract be obtained with
Service and that all repairs also be carried out by them. Otherwise
the correct functioning of the device may be compromised.
Warning! Because of the danger of electric shock, never remove
the cover of a device while it is in operation or connected
to a power outlet.
4. If one of the following situations arises, have the equipment
checked by service personnel:
■The power cord or plug is damaged.
■Liquid has penetrated into the equipment.
■The equipment has been exposed to moisture.
■The equipment does not work well, or you cannot get it to
work according to the user manual.
■The equipment has been dropped and damaged.
■The equipment has obvious signs of breakage.
5. Disconnect this equipment from any AC outlet before cleaning.
Use a damp cloth. Do not use liquid or spray detergents for
cleaning and keep this equipment away from humidity.
Caution! To avoid short-circuiting and otherwise damaging the
device, do not allow fluids to come in contact with the
device. If fluids are accidentally spilled on the equipment,
remove the affected unit from service as soon as possible
and contact the service personnel to verify that patient
safety is not compromised.

6. Put this equipment on a reliable surface during installation.
Dropping it or letting it fall may cause damage. For plug-in
equipment, the power outlet socket must be located near the
equipment and must be easily accessible.
Caution! To prevent overheating, do not cover the openings or
place the device in direct sunlight or near radiant heaters.
7. Make sure the voltage of the power source is correct before
connecting the equipment to the power outlet. Position the power
cord so that people cannot step on it. Do not place anything
over the power cord. If the equipment is not used for a long time,
disconnect it from the power source to avoid damage by transient
over voltage.
Caution! Do not leave this equipment in an uncontrolled
environment where the storage temperature is below -20°
C (-4° F) or above 60° C (140° F).
This may damage the equipment.
8. If your computer does not keep the correct time or the BIOS
conguration has been reset to default, the battery may have no
charge.
Caution! Do not replace battery yourself. Please contact a
qualified technician or your retailer.
The computer is provided with a battery- powered, real-
time clock circuit.
There is a danger of explosion if battery is incorrectly
replaced. Replace only with same or equivalent type
recommended by the manufacturer.
Discard used batteries according to the manufacturer’s
instructions.

9. Classication:
1). Supply Class I adapter
2). No applied part
3). Continuous Operation
4). Not AP or APG category
Warning! This device is not suitable for use in the presence of
flammable anesthetic mixture with air, oxygen, nitrous
oxide, or for life support systems.
10. Environmental protection: follow national requirements to dispose
of unit.
11. Maintenance: to properly maintain and clean the surfaces, use
only the approved products or clean with a dry applicator.
Caution! When servicing the device, always use replacement parts
that are qualified to Cypress standards. Cypress cannot
war-rant or endorse the safe performance of third-party
replacement parts for use with our medical device.
12. Make sure the user does not allow contact between SIP/SOPs and
the patient at the same time.
13. When networking with electrical devices, the operator is
responsible for ensuring that the resulting system meets the
requirements set forth by the following standards:
- EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
- EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for Medical electrical
systems

- EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility;
Requirements and tests
14. Accessory equipment connected to analog and digital interfaces
must be in compliance with the respective nationally harmonized
IEC standards (i.e. IEC 60950 for data processing equipment, IEC
60065 for video equipment, IEC 61010-1 for laboratory equipment,
and IEC 60601-1 for medical equipment.)
Furthermore all congurations shall comply with the system
standard IEC 60601-1- 1. Anyone who connects additional
equipment to the signal input part or signal output part is
conguring a medical system, and is therefore, responsible that
the system complies with the requirements of the system standard
IEC 60601-1-1. The unit is for exclusive interconnection with IEC
60601-1 certied equipment in the patient environment and IEC
60XXX certied equipment out-side of the patient environment. If
in doubt, consult the technical services department or your local
representative.
Caution! Use suitable mounting apparatus to avoid risk of injury.
15. Grounding reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked "Hospital Only" or
"Hospital Grade".
16. Use a power cord that matches the voltage of the power outlet,
which has been approved and complies with the safety standard
of your particular country.
Note! Environmental protection
Follow national requirements to dispose of unit.

17. “WARNING - Do not modify this equipment without authorization of
the manufacturer.”
18. “WARNING – To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth.
19. “CAUTION: This adapter Sinpro Power: Type: HPU101-107 is a
forming part of the medical device”.
20. Remove the power cord to fully turn off the device.
21. Installation is only to be carried out by trained and authorized
personnel.
22. CAUTION! WARNING! If this device was not used in the manner
which manufacturer suggested, the end system shall evaluate for
further compliance.
EXPLANATION OF GRAPHICAL SYMBOLS
IEC 60878 and ISO 3864-B.3.6: Warning: dangerous voltage
ISO 7000-0434: Caution, consult ACCOMPANYING
DOCUMENTS
IEC 60417 -5009: STAND-BY
EC 60417-5032: Alternating Current
IEC 60417-5021: Equipotentiality
IEC 60417-5031: Direct Current
ISO 7010-M002: Follow instructions for us

DISPOSING OF OLD PRODUCTS
Within the European Union
EU-wide legislation, as implemented in each
member state, requires that waste electrical and
electronic products carrying the mark shown at left
must be disposed of separately from normal
household waste. This includes monitors and
electrical accessories, such as signal cables or
power cords. When you need to dis-pose of your
display products, please follow the guidance of your
local authority, or ask the shop where you
purchased the product, or if applicable, follow any
agreements made between you and the provider.
The mark on electrical and electronic products only
applies to the current European Union Member States.
FCC CLASS B
This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a residential
environment. This equipment generates, uses and can radiate
radio frequency energy. If not installed and used in accordance
with this user manual, it may cause harmful interference to radio
communications.
Note that even when this equipment is installed and used in
accordance with this user manual, there is still no guarantee that
interference will not occur. If this equipment is believed to be causing
harmful interference to radio or television reception, this can be
determined by turning the equipment on and off. If interference is
occur-ring, the user is encouraged to try to correct the interference by
one or more of the following measures:
■The power cord or plug is damaged.
■Liquid has penetrated into the equipment.
■The equipment has been exposed to moisture.
■The equipment does not work well, or you cannot get it to work

according to the user manual.
■The equipment has been dropped and damaged.
■The equipment has obvious signs of breakage.
Warning! Any changes or modifications made to the equipment
which are not expressly approved by the relevant
standard’s authority could void your authority to operate
the equipment.
LIST OF ACCESSORIES
Before installing your Point-of-Care Terminal, ensure that the following
materials have been received:
■MED-AS402
Warning! No user serviceable parts inside; refer servicing to qualified
personnel. Only the accessories indicated on the list of
accessories above have been tested and approved to
be used with the device. Accordingly it is strongly
recommended that only these accessories be used in
conjunction with the specific device.
Otherwise the correct functioning of the device may be
compromised.

ADDITIONAL INFORMATION AND ASSISTANCE
Contact your distributor, sales representative, or Cypress' customer
service center for technical support if you need additional assistance.
Please have the following information ready before you call:
■Product name and serial number
■Description of your peripheral attachments
■Description of your software (operating system, version,
application software, etc.)
■A complete description of the problem
■The exact wording of any error messages
■This equipment is a source of electromagnetic waves. Before use
please, make sure that there are not EMI sensitive devices in its
surrounding which may mal-function therefore.
Environmental protection
■Follow national requirements to dispose of unit
Manufacturer:
Cypress technology Co., Ltd.
6F-5, No.130, Jiankang Rd., Zhonghe Dist., New Taipei City 23585,
Taiwan (R.O.C.).
TEL: [phone]
Visit the Cypress websites at en.cypress.com.tw if you need more
information.

CONTENTS
1. General Information........................................1
1.1 Introduction ............................................... 1
1.2 Specications ............................................ 2
1.3 Dimensions ................................................. 4
1.3.1 Optional Add-on Cards .................. 7
1.3.2 Cleaning and Disinfecting .............. 7
1.4 Operating Principle................................... 8
1.5 Intended User Prole................................. 8
2. System Setup..................................................10
2.1 A Quick Tour of the MED-AS402............. 10
2.1.1 Front View ....................................... 10
2.1.2 Rear View........................................ 11
2.2 Installation Procedures ........................... 12
2.2.1 Connecting the Power Cord........ 12
2.2.2 Connecting the Ground Pin ......... 12
2.3 Running the BIOS Setup Program.......... 13
2.4 Installing System Software ...................... 14
2.5 Installing the Drivers ................................ 15
3. Operation and Safety....................................22
3.1 General Safety Guide ............................ 22
3.2 Thermal..................................................... 22
3.3 Disconnect the Power ............................ 22
3.5 Proper Handling ...................................... 23

1
1. GENERAL INFORMATION
1.1 Introduction
MED-AS402 is a video recorder that supports multi-channel recording
at one time. It has video capture I/O, video display I/O and other I/
Os. Video capture I/O includes HDMI, which supports video data up
to 4k resolution and @60 frame rate, as well as Y/PbPr, CVBS, S-Video,
SDI, HDMI, DVI-I which supports video data up to FHD resolution and
@60 frame rate. There could be three I/Os for video display: DVI,
Display Port, and HDMI. Dual-link 2560 x 1600 resolution and @60 frame
rate is supported for DVI-D, while both HDMI and Display Port support
maximum resolution at 4096x2160 (4K)@60Hz frame rate
Other I/Os include RJ-45 ports, USB 3.0 ports and USB 2.0 ports, RS-232
port, and Audio out/in 3.5mm stereo jack connectors.
With the SATA 3.0 interface, the AS402 is a user-friendly computer that
system integrators can use this highly integrated multimedia system
to easily implement into your applications. Apart from that, AS402
provides SDKs and APIs for system integrators to program their video
applications efciently. In other chapters, the SDKs and APIs provided
will be described in more detail.
Intended use – MED-AS402 is intended to serve as a medical video
recorder for integration with hospital systems. MED-AS402 is designed
for general purpose used in medical image or video related
application in the hospital environment, for data collection and for
displaying information via connecting a display.
It should not be used as a life-support system. The latest version of this
user manual is available for download from en.cypress.com.tw

2
1.2 Specications
System
CPU Intel® Core™ i7-7700 3.6GHz
Memory 16GB, Up to 32GB DDR4 2133MHz
Storage 1TB, based on customers’
requirement
System input
rating
Input
Voltage 100-240 AC
Video
Input
Resolution Up to 4K
Output
Resolution Up to 4K
Compression
Format MPEG2 H.264, H.265
Audio Audio
2 (Mic-in/ Line-out) (Mic-in could be
congured as "Line-in" under Win
OS.)
IO Port
Video
Display
1 x DVI, 1 x Display Port, 1 x HDMI
(can be optional)
Video
Capture
4Kp60: 1 x HDMI
FHD (max): Y/PbPr, CVBS, S-Video,
SDI, HDMI, DVI-I (can be
optional)
COM 1 x RS232
USB Ports 6 x USB 3.0 ports
4 x USB 2.0 ports
LAN 2 x RJ-45
Audio 2 x Audio out/in 3.5mm stereo jack
connectors

3
Power Supply Input
Voltage 100-240V AC, 47-63Hz, 500W
Certication UL/CB 60601-1, CE &FCC Class B certied
Environment
Temperature 0 ~ 40°C(Operating)
-10 ~50°C (Storage/Transportation)
Humidity
10%-90% @ 40°C (non-condensing)
(Operating)
5 ~90% (non-condensing) (Storage/
Transportation)
Pressure
700-1060 hPa (Operation)
500-1060 hPa (Storage/
Transportation)
Physical
Characteristics
Dimensions
(W x H x D) 329.5mmX320mmX145mm
Weight 4.65Kg

4
1.3 Dimensions
Dimensions: 329.5 x 320 x 145 mm
Figure 1.1 Dimensions of the MED-AS402

5
Figure 1.2 MED-AS402 Front Panel
1 2
1Power button (blue light)
2USB 3.0

6
Figure 1.3 MED-AS402 Rear Panel
4 6 8 11
9 1073 5
3RS232
4DVI-D
5Display Port
6HDMI
7USB 2.0
8USB 3.0
9RJ-45
10 Headphone
11 MIC

7
1.3.1 Optional Add-on Cards
Capture cards
Part Number Description
DVP-7611HE 1ch HDV/SDI/CVBS/YPrPr/S-video PCIe
capture Card
DVP-7011UHE 1ch 4K HDMI 2.0 Video capture Card
There are SDKs and APIs for video capturing and recording which
allow system integrators to implement into their use applications. After
installing the capture cards to MED-AS402, software programmers
can easily program their customized software application. For SDKs
and APIs contents, you can download the related documents from
Cypress ofcial website.
Graphic card
Part Number Description
GFX-NG1050TF16-5D1 GTX1050TI 4G PCIEX16
DVI+HDMI+DP FHFL
1.3.2 Cleaning and Disinfecting
During normal use of MED-AS402 the device may become dirty and
should be regularly cleaned.
Steps:
1. Prepare cleaning detergent
2. Wipe MED-AS402 with a clean cloth that has been moistened in
the detergent.
3. Wipe thoroughly with a clean cloth.
Suggested cleaning detergent:
1. 10% Sodium HyAS402hlorite 90% water solution.
2. A solution of 90% water, 6% benzyl alcohol, and 3% Hydrogen
Peroxide
3. Glutaraldehyde (2.4%)

8
Caution!
• Do not immerse or rinse the AS402 or its peripherals. If
you accidentally spill liquid on the device, disconnect
the unit from the power source. Contact your IT support
department regarding the continued safety of the unit
before placing it back in operation-Do not spray cleaning
agent on the chassis.
• Do not use disinfectants that contain phenol.
• Do not autoclave or clean the AS402 or its peripherals
with strong aromatic, chlorinated, ketone, ether, or ether
solvents, sharp tools or abrasives. Never immerse electrical
connectors in water or other liquids.
1.4 Operating Principle
The device provides input through I/O ports mainly on the rear cover.
The device computes the input data with its processing unit and then
output the generated data to accessories or other devices through
its I/O ports or through its LAN connections. The device is able to store
data in its storage, and when the device is turned off, still maintain the
data in the memory units of the storage.
1.5 Intended User Prole
Intend user prole:
Age: 18 to 65
Weight: not relevant
Health: not relevant
Nationality: Global
Patient state: patient will not be the operator.
Part of the body or type of tissue applied to or interacted with: hands,
expected contact time shall be less than 1 min, and will not touch
MED-AS402 so frequently once it is set up.
Education level: at least 8 years intensive reading experience (school)

9
Knowledge:
Minimum – read and understand “westernized Arabic” numerals when
written in Arial font
- can distinguish: every parts of body as described in user manual
- trained and authorized by manufacturer only.
To be considered as trained and authorized, they must complete
the training course of the manufacturer; see document number
MED-AS402_User Manual for qualication method, when considered
necessary by the manufacturer, technician shall be called back for
retraining and annual training is also considered necessary.
Language understanding: English, whenever other languages are
required, professional translation company shall translate and review
by the manufacturer, see SOP document number: SOP_Writing_
Guidelines-ed.3 Experience: Mentally and physical competent,
specic medical training to understand basic knowledge for symbols.
Permissible impairments:
- Mild reading vision impairment or vision corrected to log MAR 0,2
(6/10 or 20/32)
- Average degree of aging-related short term memory impairment
- impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2
kHz Operating Principle:
The device provides input through I/O ports, and accessories through
USB ports or its LAN connections. The device computes the input
data with its processing unit and then output the generated data to
accessories or other devices through its I/O ports or through its LAN
connections. The device is able to store data in its storage, and when
the device is turned off, still maintain the data in the memory units of
the storage.