USM100H - Ordinateur médical Advantech - Free user manual and instructions

USER MANUAL USM100H Advantech

Acknowledgements Intel and Pentium are trademarks of Intel Corporation. Microsoft Windows and MS-DOS are registered trademarks of Microsoft Corp. All other product names or trademarks are properties of their respective owners. Intel et Pentium sont des marques d'Intel Corporation. Microsoft Windows et MS-DOS sont des marques déposées de Microsoft Corp. Tous les autres noms de produits ou marques sont la propriété de leurs propriétaires respectifs. Product Warranty (2 years) Advantech warrants the original purchaser that each of its products will be free from defects in materials and workmanship for two years from the date of purchase. This warranty does not apply to any products that have been repaired or altered by persons other than repair personnel authorized by Advantech, or products that have been subject to misuse, abuse, accident, or improper installation. Advantech assumes no liability under the terms of this warranty as a consequence of such events. Because of Advantech’s high quality-control standards and rigorous testing, most customers never need to use our repair service. If an Advantech product is defective, it will be repaired or replaced at no charge during the warranty period. For out-of- warranty repairs, customers are billed according to the cost of replacement materials, service time, and freight. Please consult your dealer for more details. If you believe your product to be defective, follow the steps below. 1. Collect all the information about the problem encountered. (For example, CPU speed, Advantech products used, other hardware and software used, etc.) Note anything abnormal and list any onscreen messages displayed when the problem occurs. 2. Call your dealer and describe the problem. Have the manual, product, and any helpful information to hand when you call. 3. If your product is diagnosed as defective, obtain a return merchandise authorization (RMA) number from your dealer. This allows us to process your return more quickly. 4. Carefully pack the defective product, a completed Repair and Replacement Order Card, and a proof of purchase date (such as a photocopy of your sales receipt) in a shippable container. Products returned without a proof of purchase date are not eligible for warranty service. 5. Write the RMA number clearly on the outside of the package, then ship it pre- paid to your dealer.iv USM-100 User Manual

Declaration of Conformity 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 pro- vide reasonable protection against harmful interference in residential installations. This equipment generates, uses, and can radiate radio frequency energy and, 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. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on again, users are encouraged to try to correct the interference using one or more of the following measures:

Reorient or relocate the receiving antenna.

Increase the distance between the equipment and receiver.

Connect the equipment to an outlet on a circuit that differs from that to which the receiver is connected.

Technical Support and Assistance

1. Visit the Advantech website at www.advantech.com/support to obtain the latest

product information.

2. Contact your distributor, sales representative, or Advantech's customer service

center for technical support if you need additional assistance. Please have the following information ready before calling: - Product name and serial number - Description of your peripheral attachments - Description of your software (operating system, version, application software, etc.) - Comprehensive description of the problem - The exact wording of any error messages

1. Strictly follow these Instructions for Use; please read these safety instructions

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. Advantech

recommends that a service contract be obtained with Advantech 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 adaptor 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 DC 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.vi USM-100 User Manual

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 -40° C (-40° F) or above 70° C (156° F). This may damage the equipment.

8. If your computer does not keep the correct time or the BIOS configuration has been reset to

default, the battery may have no charge.

1). Class I DC power adaptor 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.

11. Environmental protection: follow national requirements to dispose of unit.

12. 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 Advantech standards. Advantech Digital Healthcare cannot war-rant or endorse the safe performance of third-party replacement parts for use with our medical device.

13. Make sure the user does not allow contact between SIP/SOPs and the patient at the same time.

14. 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 testsvii USM-100 User Manual

15. 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 configurations 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 configuring 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 certified equipment in the patient environment and IEC 60XXX certified 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.

16. Grounding reliability can only be achieved when the equipment is connected to an equivalent

receptacle marked "Hospital Only" or "Hospital Grade".

17. 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.

18. “WARNING - Do not modify this equipment without authorization of the manufacturer.”

19. “WARNING – To avoid risk of electric shock, this equipment must only be connected to a supply

mains with protective earth.

20. Pressing the power button on the front cover for turn off the device back to standby mode.

Remove the DC power adaptor 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.viii USM-100 User Manual

Explanation of Graphical Symbols

Environmental Protection Follow national requirements for disposing of this unit. Disposing of Old Products Within the European Union EU-wide legislation, as implemented in each member state, requires that all waste electrical and electronic products bearing the mark shown on the left be disposed of separately from normal household waste. This includes monitors and electrical accessories, such as signal cables or power cords. To dispose of display products, follow the guidelines speci- fied by your local authority, or ask the original equipment vendor for assistance, or if applicable, follow any agreements between yourself and the manufacturer. The above mark for electrical and electronic products is only applicable in current European Union member states.12 USM-100H User Manual

INTRODUCTION Advantech’s USM-100H of the industries medical grade slim mini-computer for hospital, clinic, and Cart application and healthcare environment. Intel® 12

Gen Alder lake, Core™ i7-1265UE /I5-1245UE, owns powerful performance The slim dimension, 230 * 167.8 * 43mm, can be installed at desk, Cart, any tiny space. USM-100H features DDR 5 4800, NVME SSD and WIFI 6E & Bluetooth 5.2 to enhance capability. The design of fanless doesn’t have rumble voice. The top side of system equips the VESA 75 x 75 and 100 x100 to mount in Cart. In addition, USM-100H is medical safety standard certified (IEC-60601-1-2; Edition 4) ,and deployable as an intelligent operating room solution. USM-100H is capable of using Windows 10 or Linux OS to deliver an open source environment that eases software development. With 10 years of longevity support, Advantech’s USM-100H is an excellent, advanced, and powerful solution for medical applications.

Intended User Profile Intend user profile:

Age: 18 to 55 Weight: not relevant Health: not relevant Nationality: Global Patient state: patient will not be the operator. Occupation: medical IT engineer 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 USM-100H so frequently once it is set up. Education level: at least 8 years intensive reading experience (school) 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 USM-100H_User Manual for qualification 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, specific 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 kHz15 USM-100H User Manual

Medical Installations For integration into an IEC60601-1-compliant Medical Electrical System, the USM-100H have been tested and are compliant with IEC 60601-1-2

combination with the power supply delivered. This power supply has a low leakage current (<50uA@264VAC) and is double isolated (MOOP&MOPP).

Cleaning and Maintenance Instructions

1. Prepare cleaning water

2. Wipe USM-100H with a clean cloth that has been moistened in the pure

3. Wipe thoroughly with a clean cloth.

Test Standard: Reference ASTM D 4752-03 and in house test method of Advantech

CAUTION! This USM-100 are passively cooled by heat convection via the enclosure of the product. The temperature of the enclosure can rise to nearly 50°C at an ambient temperature of 40⁰C without air flow.

A Quick Tour of the USM-100

When you place the USM-100 upright on the desktop, its front panel appears as shown in Figure 4.1.

Figure 4-1 Front View of the USM-100H

Rear View Most of I/O ports of USM-100H are located at the rear cover, including D, COM port, HDMI port, Ethernet ports, USB ports, USB-C and so on. Apart from the I/O ports shown in below fig 4.2,

Figure 4-2 Rear View of the USM-100

NOTE: Equipotential terminal need link to hospital ground/earth system before system boot to protect operator and system.

CAUTION! Please ensure that sufficient space is available around the USM-100H for heat convection. Do not stack the USM-100H. The mains coupler is used as “disconnect device”, and must be available as such, or the socket outlet must be installed near the equipment and must be easily accessible, or an appropriate external disconnect device must be externally added in the installation.20 USM-100H User Manual

Connecting the DCIN (Medical Type) The USM-100H SERIES can only be powered by AC adapter (FSP Model no. FSP120M-KHA). Be sure to always handle the power cords by holding the plug ends only.

Follow these procedures in order:

1. Connect the female end of the power cord to AC adapter.

2. Connect the 3-pin male plug of the power cord to an electrical outlet.

Note! This adaptor is optional, if with cart and equipment products direct DC 12V power supply, do not need to use this adapter. The cart and equipment must meet the IEC60601-1 certification to pro- vide POC DC power.

Step2. Prepare the Grounding cable and the other terminal link to hospital ground/earth system.15 POC-421_424 User Manual

Running BIOS Setup Program Your USM-100H SERIES was probably set up and configured by your dealer prior to delivery. You may still find it necessary to use the BIOS (Basic Input-Output System) setup program to change system configuration information, such as the cur- rent date and time or your type of hard drive. The setup program is stored in read- only memory. It can be accessed either when you turn on or reset the panel PC, by pressing the “Del” key on your keyboard immediately after powering on the computer.

Install System Software Recent releases of operating systems from major vendors include setup programs which load automatically and guide you through hard disk preparation and operating system installation. The guidelines below will help you determine the steps necessary to install your operating system on the panel PC hard drive. Note! Some distributors and system integrators may have already pre- installed system software prior to shipment of your panel PC.

If required, insert your operating system's installation or setup diskette into the exter- nal diskette drive until the release button pops out. The BIOS supports system boots up directly from the Flash disk. You may also insert your system installation Flash disk into USB port. Power on or reset the system by pressing the “Del” key to boot into BIOS menu and adjust the boot device sequence. You can also press F12 key when booting; a bootable device popup menu will appear, you can select bootable device that you want. The Point-of-Care Terminal will automatically load the operating system from the Flash disk.16 POC-421_424 User Manual

System Setup If you are presented with the opening screen of a setup or installation program, follow the instructions on screen. The setup program will guide you through preparation of your hard drive, and installation of the operating system.

Install Driver After installing your system software, you will be able to set up the Chipset, Graphics, Ethernet, and Audio functions from your own external CD-ROM drive. All the drivers can be downloaded via Advantech official website. After installing your system software, you will be able to set up the Chipset, Graphics, Ethernet, Audio functions by driver. The standard automatic installation procedures for installing the drivers are described in Chapter 3. The various drivers and utilities in the CD-ROM disc have their own text files which help users install the drivers and understand their functions. These files are a very useful supplement to the information in this manual All driver could download from Advantech website

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environmental Guidance

energy only for its internal function.

Group 1 Therefore, its RF emissions

CISPR 11 are very low and are not likely to

cause any interference in nearby

electronic equipment.

RF emissions Class B USM-100H is suitable

for use in all establishments,

Harmonic emissions Class D including domestic establishments

and those directly connected to

the public low-voltage power sup-

Voltage fluctuations/

ply network that supplies buildings

flicker emissions Meet the requirements

used for domestic purposes.

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the USM-100H

Output Power of Separation Distance According to Frequency of Transmitter Transmitter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation in the table above applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity USM-100H is intended for use in the electromagnetic environment specified below. The customer or the user of the model USM-100H should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environmental Guidance Electrostatic dis-charge (ESD)

±8 kV contact ±15 kV air ±8 kV contact ±15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst

±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines ±1 kV for input/output lines Main power quality should be that of a typical commercial or hospital environment. Surge

±1 kV line(s) to line(s) ±2 kV line(s) to earth ±1 kV line(s) to line(s) ±2 kV line(s) to earth Main power quality should be that of a typical commercial or hospital environment. Interruptions and voltage variations on power supply input lines

i) 0% reduction for 0.5 cycle

at 50Hz, 0% reduction for 1 cycle at 50Hz Performance Criterion B

ii) 70% reduction for 25/30

cycles at 50/60Hz Performance Criterion C Voltage Interruptions: 0% reduction for 250/300 cycles at 50/60Hz Performance Criterion C Voltage Dips:

i) 0% reduction for 0.5 cycle

at 50Hz, 0% reduction for 1 cycle at 50Hz Performance Criterion B

ii) 70% reduction for 25/30

cycles at 50/60Hz Performance Criterion C Voltage Interruptions: 0% reduction for 250/300 cycles at 50/60Hz Performance Criterion C Main power quality should be that of a typical commercial or hospital environment. If the user of the model USM-100 requires continued operation during main power interruption, it is recommended that the model USM-100 be powered from an uninterruptible power supply. Power frequency (50/60 Hz) magnetic field

30A/m 30A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the A.C. main voltage prior to application of the test level.18 POC-421_424 User Manual

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The model USM-100H is intended for use in the electromagnetic environment specified below. The customer or the user of the model USM-100H should assure that it is used in such an environment.

a.Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which USM-100 is used exceeds the applicable RF compliance level above, USM-100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the unit. b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Immunity test IEC 60601 Test Level Compliance Level Electromagnetic Environmental Guidance

3 and 6 Vrms 150 kHz to 80 MHz and specific ISM, AM frequency

3 and 6 Vrms 150 kHz to 80 MHz and specific ISM, AM fre- quency Portable and mobile RF commu- nications equipment should be used no closer to any part of the model POC-421-12/POC-424-12 SERIES, including cables, than the recommended separation distance calculated from the equation applicable to the fre- quency of the transmitter. Recommended Separation Dis- tance d = 1,2 d = 1,2 80 MHz to 800 MHz d = 2,3 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the trans- mitter manufacturer and d is the recommended separation dis- tance in meters (m).

3V/m 80 MHz to 2.7 GHz, and specific frequency

3V/m 80 MHz to 2.7 GHz, and specific frequency Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

should be less than the compli- ance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following sym- bol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.19 POC-421_424 User Manual

General Safety Guide For your own safety and that of your equipment, always take the following precautions. Disconnect the power plug (by pulling the plug, not the cord), from your computer if any of the following conditions exists: a. The power cord or plug becomes frayed or otherwise damaged b. You spill something into the case c. Your computer has been dropped or the case has been otherwise damaged d. You suspect that your computer needs service or repair e. You want to clean the computer f. You want to remove/install any parts

Thermal The vent hole on the rear cover of USM-100H as well as system fans, CPU fan function as a cooling air flow inlet and outlet. These air inlets and outlets transfer heat from inside the computer to the cooler air outside. Do not block these holes/vents with any soft material, nor should its system fans and CPU fan be removed arbitrary. Warning! Do not place your USM-100H system on a pillow or other soft material when it is on, as the material may block the airflow and cause the com- puter to overheat.

Disconnect the Power The only way to disconnect power completely is to unplug the power cord. Make sure at least one end of the power cord is within easy reach so that you can unplug the computer when you need to. Warning! Your DC adaptor came equipped with a three-wire grounding plug (a plug that has a third grounding pin). This plug will fit only a grounded AC out- let. If you are unable to insert the plug into an outlet because the outlet is not grounded, contact a licensed electrician to replace the outlet with a properly grounded outlet. Do not defeat the purpose of the grounding plug. Warning! Never push objects of any kind into this product through the openings in the case. Doing so may be dangerous and result in fire or a dangerous electric shock.20 POC-421_424 User Manual

Proper Handling Handle your USM-100H with care. It is made of metal, and has sensitive electronic components inside. Don’t use a damaged USM-100H. Set USM-100H on a stable work surface. Do not push objects into the ventilation openings. To lift or move your system, hold its sides.

CERTIFICATIONS AND APPROVALS

EC Declaration of Conformity USM-100 comply to the following standards and regulations: 2014/30/EU EMC directive

IEC 61000-3-3: 2013 + A1: 2017

IEC 61000-4-5: 2014 + A1: 2017

2011/65/EC RoHS directive 2012/19/EU WEEE directive 2001/95/EC General product safety

Manufacturing USM-100H have been manufactured in compliance with ISO13485.Technolution B.V. SigmaXG User Manual 2.7.0

Please verify specifications before quoting. This guide is intended for reference purposes only. All product specifications are subject to change without notice. No part of this publication may be reproduced in any form or by any means, such as electronically, by photocopying, recording, or otherwise, without prior written permission from the publisher. All brand and product names are trademarks or registered trademarks of their respective companies. © Advantech Co., Ltd. 2020