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isopropylique ou de 70% d'alcool éthylique.
SHC-100
Ne pas immerger ou rincer le SHC ou ses périphériques. Si vous renversez
accidentellement du liquide sur l'appareil, déconnectez l'appareil de la source
d'alimentation. Contactez votre service Biomed en ce qui concerne la sécurité
continue de l'unité avant de la remettre en service.
Ne pulvérisez pas de produit de nettoyage sur le châssis.
N'utilisez pas de désinfectants contenant du phénol. Ne pas autoclaver ou nettoyer
le SHC ou ses périphériques avec des solvants forts aromatiques, chlorés,
cétoniques, éthers ou Esther, des outils tranchants ou des abrasifs. Ne plongez
jamais les connecteurs électriques dans l'eau ou d'autres liquides.
Ne rayez pas la surface de l'écran avec des objets durs.
Ne vaporisez pas de liquide directement sur l'écran ou laissez l'excès de liquide
s'égoutter dans l'appareil.
Ne placez aucun objet, tel que de la nourriture et des boissons, sur l'écran à tout
moment pour éviter d'endommager l'écran.
Nettoyez l'écran LCD uniquement avec un chiffon doux imbibé de 70% d'alcool
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SHC-100
1.6 I
NTENDED USER PROFILE
Age: 25 - 60
Weight: Not relevant
Health: Not relevant
Nationality: Not relevant
Patient state: The patient will be the operator
Part of the body or type of tissue applied to or interacted with: Hands and fingers, expected
contact time shall be less than 1 min.
Education level: At least 8 years of intensive reading experience (school)
Knowledge:
Minimum – Can read and understand “westernized Arabic” numerals when written in Arial font
– Can distinguish every part of the body as described in the user manual
– Understands the potential risks and hazards regarding misjudgment of diagnostic images.
Language understanding: English or Chinese
Experience: Mentally and physically competent, specific medical training to read medical images
and to have a basic understanding of symbols.
Permissible impairments:
– Mild reading vision impairment or vision corrected to log MAR 0,2 (6/10 or 20/32)
– One arm/hand capable of guiding and holding the device
– An average degree of aging-related short-term memory impairment
– Hearing impairment of 40 % resulting in 60 % of normal hearing levels at 500 Hz to 2 kHz
Operating Principle:
A computer processing system panel with the following main components: the arithmetic logic unit
(ALU), the control unit, the memory, and the input and output devices (collectively termed I/O).
These parts are interconnected by buses, the control unit, ALU, and registers are collectively known
as a central processing unit (CPU), the unit processes and delivers patients electronic information to
an internal touchscreen.
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Environment:
– General Requirements:
• Hospital or clinics, professional healthcare personnel use only.
• Indoor use only
• Not for use in the shower, bathtub, or sink
• The display is to be placed on a desk.
– Expected to function normally
– Conditions of visibility:
• Ambient luminance range: 100 lux to 1,500 lux
• Viewing distance: 20 cm to 40 cm
SHC-100
• Viewing angle: Normal to the display ± 45°
– Physical:
• Temperature range: 0°C to 40 °C
• Relative humidity range: 10 % to 90 %, non-condensing
• Relative altitude range: 0 to 3000m
The frequency of use: 1 to 10 times a day.
Mobility:
– Fixed MEDICAL DEVICE to be used beside a resting PATIENT.
– Fixed MEDICAL DEVICE to be used on a nursing cart.
Quality related risks are considered in FMEA (doc no. EFH00-PM-004), quality-related risks
are not considered as a result of harm; therefore risk evaluation only lists those which may cause
harm to the user.
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Intel® Core™ i5 7200U, 2.5GHz Processor, KBL
Intel® Core™ i5 7300U, 2.6GHz Processor, KBL
4G DDR4 SODIMM 2133/2666MHz (up to 32G)
Trusted Platform Module (TPM2.0) &
Wake-on-LAN/WiFi
Isopropyl alcohol 70%, Ethyl alcohol 70%
Capacitive Touch (Multi-touch:10)
Rear: USB3.0*1+USB2.0*3, Side:USB2.0*1
1(included in USB ports, support Skype for
Business )
1 (support 14443A、14443B、SRIX4K)
10/100/1000/Gigabits Mbps RJ-45
Chapter 2 Hardware Description
SHC-100
2.1 S
Hardware
Display
Touchscreen
PECIFICATIONS
CPU
Chip Set
Support Intel®
I/O
Audio
Network
Microphone in
Mini-PCIe 1
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6.3 kg (with stand: 8.5 kg)
Optional (support Skype for Business )
100 - 250 Vac, 1.5 - 0.75 A, @ 50 - 60 Hz
Storage/transportation
Temperature
10% - 90% (No Condensation)
Storage/transportation
Humidity
Storage/transportation
Altitude
approved, UL 60950, UL 62368, RoHS, CCC, CEL
Mechanical
Options
Power
-20 - 60° C
SHC-100
Environment
Certifications
10% - 90% (No Condensation)
500 - 1060 hPa
BSMI, CE,FCC Class B approval, IEC/ANSI60601-1
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SHC-100
2.2 E
2.2.1 Front View
XTERNAL VIEW
Figure 2.2.1-1 Front View
2.2.2 Side View
Figure 2.2.2-1 Side View