UH100 Diagnostic Ultrasound System User Manual
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Table of contents Copyright.................................................................................................. 2 Disclaimer................................................................................................ 2 Limit of liability.......................................................................................... 2 Contact information.................................................................................. 3 Chapter 1 Introduction.....................................
Waterproof and dustproof ratings........................................................... 28 Understand the MI/TI display................................................................. 29 Tissue model..................................................................................... 32 TI....................................................................................................... 33 MI......................................................................................................
Set the transducer orientation................................................................ 60 Adjust the displayed image.................................................................... 60 Enlarge an area of the image............................................................ 61 Split the imaging screen.................................................................... 62 Freeze an image....................................................................................
IT network failure recovery measures.................................................... 78 Chapter 7 Maintenance.............................................................81 System maintenance.............................................................................. 81 Clean the ventilation slots and connection ports/sockets.................. 81 Clean the touchscreen...................................................................... 81 Transducer precautions and maintenance.......................
1 Introduction The Qisda UH100 Diagnostic Ultrasound System (hereinafter called “system”) is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The miniaturized ultrasound system runs on the tablet computer using multi-touch operation. Commonly used applications include: abdomen, cardiac, small organ (e.g., breast, testes, thyroid), heart soft tissue, vascular, musculoskeletal (e.g.
Equipment list Check the sales package for the following items. If any item is missing or damaged, contact your place of purchase immediately.
Specifications Specifications are subject to change without prior notice. System Item Specifications Form factor Tablet Weight < 1.9kg Dimension 12.58" (W) x 8.79" (H) x 1.25” (D) 319.6 mm (W) x 223.2 mm (H) x 31.8 mm (D) Materials Plastic, metal, rubber Color White Loudspeaker Built-in loudspeakers x 2 Console Touchscreen Primary monitor 11.
Item Specifications Accessories Power adapter Input: AC 100 ~ 240V, 50 ~ 60Hz, 1.6 ~ 0.7A Output: +19Vdc, 3.43A OO Transducer P42A, L115A, C52A, E94A Storage Temperature: -25 ~ 60°C Humidity 20% ~ 95% RH Air Pressure 700 ~ 1060hPa Environmental operating conditions Temperature: 10 ~ 40°C Humidity: 20% ~ 85% RH, no condensation Air Pressure: 700 ~ 1060 hPa Product life 5 years OO Battery Model: QIC3000 Battery type (non-removable): 3S2P Panasonic-3070mAh BQ20Z70, compliant with IEC62133 standard.
Item Rate performance Remark 0 ~ 45°C Operating temperature 10 ~ 45°C -0 ~ 60°C Storage temperature and humidity range Power consumption Normal mode Sleep mode Shutdown mode -20 ~ 35°C -20 ~ 40°C -20 ~ 45°C -20 ~ 50°C Standard charging In max. charging Standard discharging Within 1 year, 45% to 85% RH Within 6 months, 45% to 85% RH Within 1 month, 45% to 85% RH Within 1 week, 45% to 85% RH ≦ 620 µA ≦ 120 µA ≦ 5.
Power adapter Item Specifications Brand Adapter Technology Co., Ltd. Model ATM065-P190 Input Universal AC 100 ~ 240V, 50 ~ 60Hz, 1.6 ~ 0.7A, without any slide switch Output +19Vdc, 3.43A Case Dimension 119 (L) * 60 (W) * 36 (H) mm Efficiency Eff (av) ≥ 87% Safety I.T.E. - PSE / BSMI (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)) Medical - UL / cUL / T-mark EMI CE / FCC Class B, Conduction and Radiation Met.
2 Safety information Follow the procedures carefully and ensure that the power/electrical/ environmental requirements are satisfied. Failure to observe the instructions or disregarding the warnings may result in damages to the system, personal injury, or even death of the operator or the patient. Please observe the following precautions carefully.
OO The power cable of the system should only be connected to a grounded power socket. Do not remove the ground cable for any reason. OO Do not connect USB peripherals with an extended USB cable. Extended connection may cause unexpected usage fault. OO Only devices that comply with the EN60601-1 standard, either electronically or mechanically, can be connected to this system.
Warning symbols The following symbols provide information about the system’s labels and regulatory compliance. System label icons Diagnostic Ultrasound System UH100 0120 XXXXXXXXXX Power:19V 3.43A FCC ID:VRSUH100N IP22 Qisda Corporation 1, 5, 7F NO.159, Shan-Ying Road, Shan-Ting Li, Gueishan Dist., Taoyuan City,Taiwan, R.O.C. Mednet Gmbh Borkstrasse 10, 48163 Muenster, Germany Figure 1 Symbols 201X-XX Made in Taiwan System SPEC label for CE MDD Ver.20150925.
Symbols 201X-XX Descriptions Manufacturer date System button Symbols Descriptions Power button Press and hold the Power button to turn on/off the system. Transducer label icons Ultrasound Transducer_Linear Array L115A / 5~11MHZ XXXXXXXXXX Qisda Corporation 1, 5, 7F NO.159, Shan-Ying Road, Shan-Ting Li, Gueishan Dist.,Taoyuan City,Taiwan, R.O.C. Ultrasound Transducer_Curved Linear Array C52A / 2~5MHz XXXXXXXXXX Qisda Corporation 1, 5, 7F NO.159, Shan-Ying Road, Shan-Ting Li, Gueishan Dist.
Symbols Descriptions Fragile Maximum Stacking Height Maximum Rated Load Sun and Rain +60°C -25°C 95% 20% Temperature The Qisda Diagnostic Ultrasound System must be stored in the original shipping container in environments between -25°C and 60°C (-13°F and 140°F). The temperature while operating the system should be kept between 10°C and 40°C (32°F and 104°F).
OO OO OO OO Electrical: »» IEC 60601-1:2005+AMD1:2012; EN 60601-1:2006+A11:2011+A 1:2013+A12:2014, Medical Electrical Equipment Part 1: General Requirements For Safety, Class I, BF, continuous operation »» IEC 60601-2-37: 2007, Medical Electrical Equipment Part 2-37: Particular Requirements For The Safety of Ultrasonic Medical Diagnostic And Monitoring Equipment EMC/EMI: »» IEC 60601-1-2:2007/AC:2010, CISPR 11 Group I Class B Harmful liquid protection: »» For the main system: IP22 »» For the transducer:
Battery usage/disposal OO OO OO Do not disassemble the system. Use only the supplied battery. Using an unapproved battery may cause the system to explode and result in serious damage to your health or property. Do not replace, heat, crush, puncture, short external contacts, or incinerate the battery. OO Use only the supplied power adapter to charge the battery.
All equipment The UH100 is intended for use in the electromagnetic environment specified below. The customer or operator of the UH100 should ensure that it is used in such an environment. Guidance and manufacturer’s declaration - Electromagnetic emissions - All equipment Emissions test Compliance Electromagnetic environment - Guidance RF Emissions CISPR 11 Group 1 The Qisda Diagnostic Ultrasound System uses RF energy only for its internal function.
Immunity test Voltage dips/ Dropout IEC 61000-4-11 IEC 60601 test level Compliance Electromagnetic level environment - Guidance >95% dip for 0.5 As Mains power quality cycle specified should be that of a typical commercial or hospital 60% dip for environment. If the user 5 cycles of the UH100 requires 30% dip for continued operation during 25 cycles power mains interruptions, >95% dip for it is recommended that the 5 seconds UH100 be powered from an uninterruptible power supply or battery.
Immunity test IEC 60601 test level Compliance Electromagnetic environment level Guidance Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency rangeb.
Maximum Output Power of Transmitter Watts (W) Separation Distance According to Frequency of Transmitter Meters (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 3.5√P 3.5√P 7√P =D =D =D V1 E1 E1 0.01 0.12 m 0.12 m 0.24 m 0.1 0.37 m 0.37 m 0.74 m 1 1.17 m 1.17 m 2.34 m 10 3.69 m 3.69 m 7.38 m 100 11.67 m 11.67 m 23.
RF safety The system should be operated in a location that is no closer than listed in “Non-Life-Supporting Equipment” to any part of RF communications equipment that may disturb its functions. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment. The system should be separated by at least the distances specified in the table referenced above.
Heating Elevating tissue temperature during obstetrical examinations creates medical concerns. At the embryo development stage, the rise in temperature and the length of time exposed to heat combine to determine potential detrimental effects. Exercise caution, particularly during Color Doppler imaging exams. The Thermal Index (TI) provides a statistical estimate of the potential temperature elevation (in centigrade) of tissue temperature.
OO OO OO OO Take particular care to reduce output and minimize exposure time of an embryo or fetus when the temperature of the mother is already elevated. Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when exposing an embryo less than eight weeks after gestation, or the head, brain or spine of any fetus or neonate. Do not use endocavity transducers if there is noticeable self-heating of the transducer before insertion.
TI Maximum exposure time (minutes) 0.7 60 1.0 30 1.5 15 2.0 4 2.5 1 Table 2 Maximum exposure time recommended for an embryo or fetus OO Diagnostic ultrasound has the potential for both false positive and false negative results. Misdiagnosis is far more dangerous than any effect that might result from the ultrasound exposure. Therefore, diagnostic ultrasound should be performed only by those with sufficient training and education.
The following table lists the applied parts and their levels of protection.
For transducer/mode combinations marked “ V”, the MI or TI index is equal or greater than 1.0.
For any diagnostic ultrasound systems, Track-3 provides an Output Indices Display Standard. The diagnostic ultrasound systems and its User Manual contain the information regarding an ALARA (As Low As Reasonably Achievable) education program from the clinical enduser and the acoustic output indices, MI and TI. The MI describes the likelihood of cavitation, and the TI offers the predicted maximum temperature rise in tissue as a result of the diagnostic examination. In general, a temperature increase of 2.
Distance (cm) Frequency (MHz) 1 3 5 7.5 4 0.7586 0.4365 0.2512 0.1259 5 0.7080 0.3548 0.1778 0.0750 6 0.6607 0.2884 0.1259 0.0447 7 0.6166 0.2344 0.0891 0.0266 8 0.5754 0.1903 0.0631 0.0158 Table 5 I’ = I * R F Where I’ is the intensity in soft tissue, I is the timeaveraged intensity measured in water. Tissue model Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode. Six models are developed to mimic possible clinical situations.
Unscanned Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the transducer is moved to a new position. For instance, the PW and M mode. TI TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to raise tissue temperature by 1°C (Wdeg), TI = W.
Display guideline For different operation modes, different indices must be displayed. However, only one index needs to be shown at a time. Display is not required if maximum MI is less than 1.0 for any setting of the operating mode, or if maximum TI is less than 1.0 for any setting of the operating mode. For TI, if the TIS and TIC are both greater than 1.0, the scanners need not be capable of displaying both indices simultaneously. If the index falls below 0.4, no display is needed.
Test External use (°C) Non-external Use (°C) C52A P42A L115A E94A Simulated use 1.5 1.4 3.0 1.9 Still air 7.3 3.6 6.5 3.3 Table 7 Transducer surface temperature rise Intended use The system is designed for use as a diagnostic tool and should only be operated by someone who has received proper training in the use and operation of a diagnostic ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional.
The patient environment is defined as shown in the following figure. Overhead view Patient table 1.50 m Side view 2.50 m 1.50 m 1.50 m Figure 4 Patient environment Portable and mobile RF communications equipment can affect medical electrical equipment such as the system and should not be used in the patient environment. The system should not be used adjacent to or stacked with other equipment.
Indications for use The following tables provide Diagnostic Ultrasound Indications for Use forms for the transducers offered with the Qisda Diagnostic Ultrasound System.
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: UH100 Diagnostic Ultrasound System Transducer: L115A (5-11 MHz Linear Array) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application General (Track 1 only) Specific (Track 1 and 3) Mode of operation Tissue Color Power Comb Harmonic Doppler Doppler Modes* Imaging B M PWD X X X X X Note 1 X Musculoskeletal (Conven.
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: UH100 Diagnostic Ultrasound System Transducer: P42A (2-4 MHz Phased Array) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application General (Track 1 only) Specific (Track 1 and 3) Mode of operation Tissue Color Power Comb Harmonic Doppler Doppler Modes* Imaging B M PWD X X X X X Note 1 X Cardiac adult X X X X X Note 1 X Cardiac pediatric X X X X X Note 1 X Fetal Ab
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: UH100 Diagnostic Ultrasound System Transducer: E94A (4-9 MHz Micro-curved Linear Array) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application General (Track 1 only) Specific (Track 1 and 3) Mode of operation Tissue Color Power Comb Harmonic Doppler Doppler Modes* Imaging B M PWD X X X X X Note 1 X Trans-rectal X X X X X Note 1 X Transvaginal X X X X X Note 1 X X
3 Get Started System overview Front and side views 3 1 2 3 14 13 12 11 10 9 4 8 7 6 No. Item 5 Function 1 Camera lens Used to take pictures or record videos. 2 Touchscreen Display system information and allows you to perform operations using different gestures. 3 Speakers Built-in speakers for playing sounds, which are software-controlled. Transducer 4 connection socket Connect a transducer to the system.
No. Item 9 AUX port Function Services only 10 HDMI port Connect the system to an HDMI (High-Definition Multimedia Interface) device. 11 Ethernet socket Connect the system to an Ethernet-based network. 12 USB 2.0 port 13 USB 3.0 port Connect the system to USB 2.0/3.0 devices, such as keyboards, pointing devices, cameras or portable storage devices. 14 Headphone jack Connect the system to an audio device, such as headphones or speakers. Rear and top/bottom views 15 16 16 17 18 19 16 No.
Insert a microSD card (optional) OO OO The system supports microSD cards (formatted in FAT32 only) up to 64 GB in size. The microSD card is available only by separate purchase. 1. Align the microSD card with the mark next to the microSD card slot. 2. Fully insert the microSD card into the card slot until it clicks into place.
Use the stand 1. Rotate the rotating stand counterclockwise by 90 degree. 2. Gently pull out the rotating stand to the degree that suits your preferred viewing angle.
Charge the system The system is only partially charged when first unpacked. Charge the battery fully for 3 hours before using the system for the first time. OO OO Use only the supplied power adapter and power cord for charing. Do not try to repair or replace the battery or the power adapter. Any attempt to disassemble the system and the supplied accessories may cause damage to the system or result in personal injury. 4 1 3 2 1. Lift the protective rubber cover open. 2.
Connect the transducer Flip the transducer cover open a and insert the transducer carefully into the transducer connection socket until it is locked in place. a Remove the transducer Press and hold the release latch, and carefully pull out the transducer.
Use the system on the go 1. Rotate the rotating stand clockwise by 90 degree. 2. Use the rotating stand as a handle to carry the system around.
Wall-mount the system The hole pattern on the rear side of the system is compliant with VESA standard. Therefore, the operator can install the system on any VESA wall mounts, desktop or ceiling mounts. 1. Hold the system firmly and position it precisely to the front of the mount plate where the hole patterns on both the back of the system and the plate meet. 2. Hold an appropriate screwdriver and carefully drive four screws to tighten the system with the mount plate.
4 Basic operations To conduct an ultrasound exam, complete the general procedure: 1. Connect the transducer (See page 46). 2. Turn on the system (See page 49). 3. Add a new patient (Patient screen), or load a work list (Work list screen). 4. Select an exam type and preset (Preset screen). 5. Start real-time imaging (Imaging screen (Real-time)). 6. Set the transducer orientation (See page 60). 7. Select a scan mode and adjust image controls (See page 70). 8.
OO If a transducer is connected, the system enters the imaging screen in B-mode after system startup. Adam, Smith 1234567 Menu B Color M Power 27 01/01/1988 Liver 09/03/2015 02:56PM Dr. Smith Medical Center TI 0.11 MI 0.92 CLA PW 0 B Gain 58 Gn 58 15.0cm 15FPS 1/ 1 M/ 80.0 60/ 0 0/ 4 Depth 15.0 Focus 8.0 DYN Range 60 12 B Function Freeze OO Save Image Fun.
OO OO Do not connect the system to any external drives until the startup process completes to avoid damage or loss of data. If an error message occurs after system startup, turn off the system immediately and contact the service technician for help. Identify the main screen layout System menu screen Touch Menu to display the following system menu screen. Touch an icon to perform its function. 1 2 3 4 Patient Work list Exam history Report Preset Review Setting User 8 7 6 5 Figure 5 No.
No. Function Description 7 Review View, add annotations and measurements to, and export a saved exam. 8 Preset Select the predefined preset compatible with the connected transducer for optimized image control settings. Imaging screen (Real-time) With the transducer connected correctly, the system automatically enters the real-time imaging screen after starting the ultrasound software.
