Document No.: Bladder Scanner Model:M5 User Manual Version: M5_V1.0.0.1 Suzhou PeakSonic Medical Technology Co.Ltd.
Document No.: Contents User Manual .................................................................................................................................................................. 1 Version: M5_V1.0.0.1 ................................................................................................................................................... 1 Contents ..................................................................................................................................
Document No.: 5.16 Expert Mode Bladder 3D Image .................................................................................................................... 5 5.17 Easy Mode Bladder 3D Image ....................................................................................................................... 6 5.18 Intelligence Mode Bladder 3D Image ............................................................................................................ 6 5.
Document No.: 6.9.4 Alert ....................................................................... 15 6.9.5 Poweroff .................................................................... 15 6.9.6 Language .................................................................... 16 6.9.7 Calibrate .................................................................. 16 6.9.8 FPGA Software Upgrade ....................................................... 16 6.9.9 Date & Time ..............................................
Document No.: Chapter I Overview Statement: The right of interpretation of the document belongs to Suzhou PeakSonic Medical Technology Co.Ltd. No unit or individual may photocopy, copy or translate the document into another language without the permission of the company. The rights to revise and modify the contents and terms of the document belong to the company. The revision and modification of the document will not be separately notified.
Document No.: sults. • The instrument is non-invasive, reliable, quick and easy to operate for measurement of the bladder wall thickness. 2D B-mode images are displayed after scan. Once the bladder position has been located, press SCAN to freeze the image. Images are processed further to extract relevant information for bladder wall thickness calculation. • Two orthogonal images, patient information and volume values can be printed for bladder volume.
Document No.: Serial number Follow the instructions Production date Type BF applied part EC REP—Authorized Representative in the European Community Warning or Caution—Consult accompanying documents. Read instructions before connecting or operating.
Document No.: Limit number of stacking layer Keep dry Avoid heat 1.4 Service Life The life cycle of this product is 6 years. Continued use of this product after the life cycle will lead to increased fault rate of the product and unexpected risks. Warning: All risks arising from the continued use of the product after its life cycle shall be borne by the user. Note: The scrapping and disposal of the product shall comply with local regulations. Do not scrap them with household waste. 1.
Document No.: 3. Atmospheric pressure range: 70KPa～106KPa 1.6 Statement on Electromagnetic Compatibility The use of the equipment does not affect the normal wired and wireless information transmission and the performance of other electronic equipment. It can work normally in the specified electromagnetic environment.
Document No.: Warning: If the user doesn’t use the battery of the model specified by the manufacturer, there may be unforeseen electromagnetic compatibility problems which prevent instrument from working normally. Therefore, the battery of the model specified by the manufacturer must be used. Warning: When charging the battery when it is in the instrument, the power supply of the instrument shall be disconnected, so the instrument cannot be used during battery charging. 1.
Document No.: Warning: If the equipment is modified, corresponding detections and tests must be carried out in the department designated by the state to ensure that the equipment can be used continuously and safely. 1.8 Contraindications Do not use the Bladder Scanner on the following cases: • Fetal use or pregnant patients. • Patients with ascites. • Patients with open or damaged skin. • Patients with wounds in the suprapubic region. • Patients with urinary catheter insertion 1.
Document No.: Chapter II Precautions In order to ensure safety, please read the following contents before using the equipment. This instrument is only allowed to be operated by personnel confirmed or authorised by the relevant medical institution. 2.1 Inspection before Operation • Before operation make sure all cables are connected correctly. • The instrument is normal. • Keep the instrument away from the hot or wet objects. Make sure the instrument is in the right place for safe operation.
Document No.: • Protect the probe against collision during operation. Apply the coupling agent on the probe to enable better contact with the body. • Closely monitor the running of the instrument and the status of the patient. Turn off the power immediately in case of any problem. • Prevent the patients from touching the instrument or any other electronic appliances. • Keep the vent of the instrument open. 2.4 After Operation 1. Switch off the power. 2. Unplug the cable. 3.
Document No.: 2.7 Relocate the Instrument 1. Unplug the cable 2. Prevent falling, vibration or collision 2.8 Malfunction In case of malfunction, turn off the power supply immediately, plug off the battery and contact the qualified maintenance personnel. 2.9 Regular Inspection and Maintenance of the Instrument 2.10 Do not Disassemble the Instrument or Probe 2.11 Startup Connect the cable with power adapter and plug into the power supply.
Document No.: Chapter III System Introduction 3.
Document No.: Figure 3-2 M5 Side View Figure 3-3 M5 Back View 3.2 Technical Specifications • Probe: P1/2.5MHZ 3D mechanical sector-scanning • Nominal ultrasonic operating frequency: 2.
Document No.: projection, 3D image • Bladder 2D scan display: real-time scan images, bladder wall thickness value • Information storage: Images, results and other information of the patient can be stored.
Document No.: 3.3 Block Diagram Figure 3-4 M5 Electricity Principle 3.4 Basic Principle This product is a non-invasive bladder urinary volume measurement device. It non-invasively measures bladder capacity and bladder wall thickness using ultrasonic imaging technology. It adopts Android system, high resolution display screen and capacitive touch screen. By the end of the scanning 12 images are obtained using 3D ultrasonic probe.
Document No.: L4 and L5. The volume of the right part of the bladder scanning section is the sum of the volume values corresponding to L1, L2, L3, L4 and L5. The volume of the left part shall be calculated with the same method as that of the right part. The volume value of one scanning section is the sum of the volume values of the right and the left parts. The volume of the whole bladder is the sum of 3-dimensional volume of 12 scanning sections.
Document No.: 3.5 Instrument Components • Instrument model: M5 • Software: Version M5_V1.0.0.1 • Power adaptor: Model FY1355000, Specifications (input a.c.220V 50/60Hz, 1.2A 120VA, output d.c.13.5V 5A） • Probe: P1/2.5MHZ, Specification (2.5MHz, 3D mechanical sector scanning, sector angle: 120 degrees) • User Manual • Lithium battery: PC063-M5（3ICR19/65） 11.1Vd.c.
Document No.: Chapter IV Installation 4.1 Unpacking & Initial Inspection Open the box and inspect whether there is any transportation damage. Verify according to the "packing list" and ensure you have received all appropriate components. Install according to the requirements and methods specified in “4.2". 4.2 Installation and Disassemble • Check the power supply of the power adapter.
Document No.: Figure 4-1 M5 connection between cart frame and the console • Connect the probe with the host machine: align the red dot on probe with the red dot on the side of the host. Plug in the probe (shown as figure 4-2) Figure 4-2 M5 Connect the probe with the console Install and remove the battery: please follow the steps below (as shown in figure 4-3) Install the battery: Step 1. Slide the battery door ① according to the arrow direction. Step 2.
Document No.: Figure 4-3 M5 Install and Remove the battery 4.3 Power Supply Power supply mode of the instrument: Battery or AC. The power supply mode can be converted to each other. 4.3.1 Power Supply by AC • Check whether the power adapter is normal: the power supply voltage is within the specified range; insert the AC input plug of the power adapter into the power supply socket, the output of the power adapter is d.c.13.5v and the green light of the power adapter is on.
Document No.: 4.3.2 Power Supply by Battery • Install the battery in the host machine following “4.2”, press start button and power indication light (green light) on the left side will be one indicating the instrument is powered and on working status. 4.3.3 Charge the Battery Host battery is charged through the host • Install the battery in the host • Plug the output plug of the power adapter into the d.c.13.
Document No.: Chapter V Instrument Interface 5.1 Startup Figure 5-1 M5 Startup Page 5.
Document No.: Figure 5-2 M5 Home Page A: Setting Logo J: Bladder Capacity B: Probe Frequency K: Bladder Volume Value C: Parameter L: Bladder Projection Crosshair D: Measurement Target M: Horizontal Line of the Crosshair E: Scan Complete Icon N: Vertical line of the Crosshair F: Scan Complete Grid View O: Scan Completed G: Enter New Patient ID P: Gender Display H: Gender Selection Icon Q: Device Operation Instruction I: Patient History Information 5.
Document No.: 5.4 Pre-scan under Expert Mode A B Figure 5-4 M5 Expert Mode Pre-scan Interface A: Real Time Bladder Display B: Bladder Projection 5.5 Scan under Expert Mode A B Figure 5-5 M5 Expert Mode Scan Interface A: Display total number of B-Mode scan images.
Document No.: and bladder volume has been calculated B: B-mode scan images are displayed one by one. Upon completion all 12 images are displayed on the screen 5.6 Expert Mode Scan Complete Interface A B C D Figure 5-6 M5 Expert Mode Scan Complete Interface - Gallery View A: Bladder Volume After Scan C: Bladder Projection Image B: Bladder Capacity D: Twelve B-Mode Images Gallery View 5.
Document No.: A: Four B-Mode Images in Grid View (two orthogonal images at horizontal direction） B: Previous Page C: Horizontal Axe of the Grid D: Next Page E: Vertical Axe of the Grid 5.
Document No.: 5.9 Scan under Easy Mode Figure 5-9 M5 Easy Mode Scan Interface 5.
Document No.: 5.11 Easy Mode Scan Complete Interface - Grid View Figure 5-11 M5 Easy Mode Scan Complete Grid View 5.
Document No.: 5.13 Scan under Intelligence Mode Figure 5-13 M5 Intelligence Mode Scan Interface 5.
Document No.: 5.15 Intelligence Mode Scan Complete Interface - Grid View Figure 5-15 M5 Intelligence Mode Scan Complete Interface - Grid View Remark: Scan Complete Interfaces of Intelligence and Expert Mode are appeared the same 5.
Document No.: 5.17 Easy Mode Bladder 3D Image Figure 5-17 M5 Easy Mode Bladder 3D Images 5.
Document No.: 5.19 Bladder Wall Thickness Scan Interface A B C D E F G H I J K L Figure 5-19 M5 Bladder Wall Thickness Scan Interface A: Measurement Object G: Enter New Patient ID B: Bladder Wall Thickness Calculation Icon H: Gender Selection C: Bladder Thickness Display I: Patient History Information D: Reduce the Image J: Parameter (Thickness) E: Enlarge the Image K: Bladder Wall Thickness Value F: Full Screen Image L: Bladder Wall B-Mode Scan Image 5.
Document No.: A: Bladder Wall Selection Window 5.
Document No.: 5.22 Patient History Information Browse and Login A B Figure 5-22 M5 Patient History Information Browse and Login A: Login Password to Enter Database B: Password Entry Keyboard 5.
Document No.: E: Print Patient Information L: Saving Date & Time F: Edit Patient Information M: Saved Age G: Delete Selected Patient Information N: Patient History Information Incl. Measurement H: Search Patient Information Time, Parameter and Result I: Saved Patient ID O: Delete or Export Information J: Saved Name P: Patient Image Information K: Saved Gender .
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Document No.: 5.26 Patient Bladder Wall Thickness Images A A B Figure 5-26 M5 Bladder Wall Thickness Images A: Scan Image of the Bladder Wall Thickness (big in size) B: Scan Image of the Bladder Wall Thickness (small 5.
Document No.: 5.28 Patient History Information Upload A B Figure 5-28 M5 Patient History Information A：Enter Login Password for Data Upload B：Virtual Keyboard for Data Entry 5.
Document No.: C：Return to Information Selection Interface E：WIFI Connection D：USB Connection 5.30 Patient History Information Batch Deletion A B C D Figure 5-30 M5 Patient History Information Batch Deletion A：Confirm Deletion Prompt C：Cancel Deletion B：Prompt Message D：Confirm Deletion 5.
Document No.: Figure 5-31 M5 System Setting A: Select Gender G：Select Language B: Select Operation Mode C: Select to Print H：Update Software D: Set up Volume Threshold Alert I：Set up Date and Time E: General Information Display F: Set up Automatic Shutdown Time J: Settings K: Return to the Home Page 5.
Document No.: 5.33 Printing Options A B C D E F Figure 5-33 M5 Set up Print Interface A: Select to Print Information B: Option of Printing Basic Information C: Option of Printing Basic Information and Two Orthogonal Ultrasound Images D: Option of Printing Basic Information and Bladder Projection Image E: Option of Printing Basic Information, Two Orthogonal Ultrasound Images and Bladder Projection Image F: Tick to Confirm Printing 5.
Document No.: C: Alert When the Bladder Volume Reaches 200ml D: Alert When the Bladder Volume Reaches 250ml E: Alert When the Bladder Volume Reaches 300ml F: Alert When the Bladder Volume Reaches 350ml G: Alert When the Bladder Volume Reaches 400ml H: Confirm to Turn off the Alert 5.
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Document No.: Figure 5-37 M5 Software Upgrade and Calibration Progress A: Software Upgrade and Calibration Progress in Percentage 5.
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Document No.: 5.40 Management Interface C D A E B F G H I Figure 5-40 M5 Management Interface A: Return to the Home Page F: Save Password to Save History Information B: Save the Current Entry e.g. Password, Hospital G: Enter New Password for Data Upload Name, Department H: Enter New Password to Browse History C: Enter Hospital Name Information D: Enter Department Name I: Enter New Password for Administrator E: Save Password for Data Upload 5.
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Document No.: Chapter VI Operation Procedure 6.1 Startup and Shutdown Long press the power button to switch on the device. After about 3 seconds, the company logo appears (Figure 5-1), and the main page is displayed in about 30 seconds. When the instrument is turned on, press the power button for a few seconds, the instrument enters the screen saver state and the screen turns black. Press the power button again to release the screen saver, and the instrument will resume its working state.
Document No.: When the bladder wall thickness measurement is selected, the thickness value xxmm, 3D images and projection images are displayed on the left side of the screen. Scan completion icon appears at the bottom left of the screen. After scanning, click this key to enter patient information input, editing, storage and printing.
Document No.: image aligns with the green indication line in the middle of the screen. Under pre-scan of the easy mode, observe the bladder sections and move the probe till the biggest section is obtained. While achieving the biggest sectional view, make sure the centre of the section aligns with the middle point of green indication line. Under pre-scan of the intelligence mode, observe the position of the bladder projection.
Document No.: as the gallery view. In the image display zone on the right side of the screen four images will be displayed which are 01 and 07 above and 02 and 08 below. Every two images are displayed orthogonally. Press ＞ to display the combination of 03 and 09 on top and 04 and 10 on the bottom. Press > again to display the combination of 05 and 11 on top and 06 and 12 on the bottom. Press < to display the orthogonal combination which is opposite to the previous ones.
Document No.: 6.4.2.3 Intelligence Mode During scan twelve B-Mode bladder images are displayed on the right side of the screen. Serial number of the images increases from 01 to 12. When it appears as 12/12, it means scan, image analysis and volume calculation is completed. Under gallery view, bladder volume and 3D bladder projection appears on the left side of the screen.
Document No.: twelve images displayed on the bottom right side by side. Slide left or right to view all twelves images. Tap on any of them, an enlarged image appears. Once grid view is chosen, bladder volume and 3D bladder projection appears on the left side of the screen. In the image display zone on the right side of the screen four images will be displayed in grid which are 01 and 07 on the top and 02 and 08 on the bottom. Every two images are displayed orthogonally.
Document No.: 1:1 image for further selection. Press or to zoom in and out. Keep the figure contact with the screen to move the image up and down, left and right so that the targeted part could be moved to the centre of the display area. The alternative is not to conduct any of the above mentioned movement to have the original image displayed. Press to enlarge bladder wall selection window. Keep pressing the window and move up and down or left and right till the selected area is targeted.
Document No.: 6.7.3 Print Patient Information Tap to print out the information from the database. Before printing, data need to be decrypted. Data entry could happen before or after the printing. Patient ID, age, gender, save time & date, bladder volume value, two orthogonal B-ultrasound images(optional), bladder projection image(optional) can be printed.
Document No.: Press patient history information search column, virtual key board pops up. Enter patient name and press , the system will then start searching required information in the database. If the patient has a couple of history information saved in the system, press ∨ below the age to display all the information at chronological order. Tap ∧ to collapse the list. Select one patient out of the list, tap information. Tap to print the information. And tap to edit the to delete the information. 6.8.
Document No.: batches. Tap to upload the information to PC. Tap exportation interface (Figure 5-27) on which turns green Press to enter information deletion and becomes . indicating they are activated. , a white tick box appears in front of each line. Tick the box √ to select the ones need to be deleted. The background color turns to green once it’s selected. Press Then tap on to select all lines. . A prompt “Confirm the deletion？” Pops up.
Document No.: 6.8.6 Browse Bladder Volume Scan, 3D and Projection Images Twelve bladder scan images are displayed in the history information display area once a patient is selected. Choose to have gallery view and choose to have grid view. Twelve images in gallery view as shown in Figure 5-24. Slide the images on the bottom left or right to view the twelve scan images, 3D images and projection images. Tap on one of the twelve, the image will be enlarged and appear in the middle of the screen.
Document No.: 6.9.1 Set Gender Tap on “Gender” in the system setting menu (Figure 5-31) and activate it by pushing the button to the right and color turns to green. appears on the up right corner of the screen. Tap on it to see the list which includes male, female, femaleH, child and phantom. Press “gender” again to collapse the list. 6.9.2 Set Operation Mode Press “Mode” in the menu to choose operation mode (Figure 5-32). There are three operation modes: expert mode, easy mode and intelligence mode.
Document No.: target. Twelve B-ultrasound images and their serial numbers are displayed at the same time. The serial number increases from 01/12. Once it reaches 12/12, scan, image analysis and calculation are accomplished. Automatically the first image (01/12) is displayed on the screen and below that the rest are displayed in gallery view. Bladder volume and projection images are also shown on the screen. Tap on the projection to see 3D image or tap on the 3D image to return to the projection view.
Document No.: 6.9.6 Language Press “Language” to enter setting interface (Figure 5-36). There are 13 languages available to chose including English, simplified Chinese, traditional Chinese, French, Danish, Finnish, Portuguese, Swedish, Spanish, Dutch, Norwegian, German, Italian. By default, English is the system language. appears behind the selected option. 6.9.7 Calibrate Calibration is not available for normal users. It is managed by the manufacturer or the dedicated service team. 6.9.
Document No.: modify administrator password are being managed. Enter new passwords to access patient history information, export patient history information and modify administrator password and press to save the new entries. Slide the button next to “Memorize history” to the right, it turns to green. Login password to access patient history data is saved and users do not need to enter the password again in the future operation. It is the same for “Memorize upload”.
Document No.: 6.11 Export Data A software is available in the upper computer for M5. This software is used to export patient data from M5 to the upper computer, display the data, convert the file to PDF and print, manually enter and save hospital name, department and doctor’s names, manage login and as well as manage passwords. All patient data are encrypted during the whole process. 6.11.1 Install and Logon Upper Computer Software Copy “release” folder to the upper computer.
Document No.: Upper computer main page as shown in Figure 11-2 A B C D E F G H I K J Figure 11-2 M5 Upper Computer Main Page A: Import Data G: Scan Date B: Print H: Bladder Volume C: Save to PDF I: Play Voice Record D: Other Options J: Bladder Image Display Zone E: Patient Age K:Patient ID F: Patient Gender 6.11.
Document No.: USB”. Chose one of the options and then chose the destination disk to import data from the device to the upper computer. Upper Computer Import Data Interface as shown in Figure 11-3 A B Figure 11-3 M5 Upper Computer Data Import A: Data transfer through WIFI B: Data import through USB cable 6.11.4 Options Press Option to pop up a dropdown menu. Select “Settings” to open the dialogue window. Enter information and press SAVE to return to the previous page.
Document No.: A B C D E Figure 11-4 M5 Option Interface A: Hospital Name D: Cancel the New Entries B: Department Name E:Save the New Entries C: Doctor Name 6.11.5 Upper Computer Printing Interface Press “Print” and pop up printing interface which includes option button to display six images or twelve images, printing button, hospital name, department name, patient information and bladder ultrasonic images.
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Document No.: A Figure 11-6 M5 Upper Computer Printing Interface (twelve images plus projection) A: Twelve Bladder Ultrasonic Image plus Projection Image 6.11.6 Save as PDF Press “Save to PDF” to pop up corresponding window. Options are chose the path to save document, enter document name, select document type which can only be PDF (*.pdf). Save as PDF function makes it convenient to check patient information and bladder images.
Document No.: 6.11.7 Change Password of Upper Computer Press OPTION than PASSWORD to manage password of the computer. Enter six digits old password and then enter twice the new passwords. Tap SAVE to save the new password. Password management interface of the upper computer as shown in Figure 6-7 A B C D Figure 6-7 M5 Change Password Interface of Upper Computer A: Enter Old Password C: Confirm New Password B: Enter New Password D: Save New Password 6.
Document No.: ure on the right, the bladder lies in the hypogastrium of human body and below the symphysis pubis. Before inspection, apply the ultrasonic coupling agent to the skin 3cm above the pubic bone of the patient. Place the instrument at the position shown in the figure and orient the Logo of the instrument towards the head of the patient. Under expert mode, press SCAN for the first time to activate pre-scan. During pre-scan a green indication line at the centre of the image appears.
Document No.: Chapter VII Maintenance To ensure the normal operation of the instrument, clean the instrument parts, accessories and probe regularly. The material used for cleaning is neutral detergent. 7.1 Clean and Maintain the System 7.1.1 Cleaning and Disinfection Steps (1) Shut down the system. (2) Use mild, nearly neutral detergent, ethanol (75%) or isopropanol (70%) to clean equipment (including keyboard).
Document No.: 7.2.1 Cleaning and Disinfection Steps (1) Check the probe, for example: Cracking, liquid leakage, etc. If there is obvious damage, do not continue to use the probe, and immediately contact Suzhou PeakSonic Medical Technology Co.Ltd... (2) Wipe the probe with neutral detergent, ethanol (75%) or isopropanol (70%). 7.2.2 Maintenance For the probe contact surface, carefully protect it from scratch. (1) Collision and falling are strictly prohibited.
Document No.: Chapter VIII Transportation and Storage 8.1 Precautions for Handling Instrument (1) Place the host in the corresponding place of the workbag. The probe and the instrument shall be strictly prevented from falling, vibrating or colliding. (2) After the workbag is closed, it can be transported. (3) Tighten the bottle cap of ultrasonic coupling agent to prevent the gel from flowing out and put it in the corresponding place of the workbag. 8.
Document No.: Chapter IX Troubleshooting 9.1 Inspection ● Check whether power supply is normal, whether the cable is connected with the console and has plugged into the power socket. ● Check whether the probe and the console has been correctly connected. 9.2 Troubleshooting Serial No. Issue Troubleshooting 1 1. Inspect whether the battery is installed and After pressing the power button, charged power indicator is not on and no 2. Inspect power supply image displayed on the screen. 3.
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Document No.: Appendix C Technical Specification for Electromagnetic Compatibility Table 201 Guidance and statement of the manufacturer-electromagnetic emission M5 portable bladder scanner is intended for use in the electromagnetic environment specified below. The purchaser or user shall ensure that it is used in such an environment. Emission test Conformity Electromagnetic environment-guideline RF emission GB 4824 Group 1 M5 portable bladder scanner uses RF energy only for its internal functions.
Document No.: Surge GB/T 17626.5 ±BKV wire to wire ±2KV wire to wire ±1KV wire to wire ±2KV wire to wire Quality of network power supply shall be equal to that in typical commercial or hospital environment. On power input line Voltage sag, Short interruption and voltage change GB/T 17626.11 <5%UT, continuous for 0.
Document No.: The portable and mobile radiofrequency communication equipment shall not be closer than the recommended isolation distance to any use part of the M5 portable bladder scanner including cables. And the calculation of that distance shall use a formula corresponding to the frequency of the transmitter. Recommended distance d=1.2 Radio-frequency transmission GB/T 17626.6 Radio-frequency radiation GB/T 17626.3 3V (effective value) 150KHz～80MHz 3V/m 80MHz～2.5GHz 3V (effective value) d=1.
Document No.: Table 206 Recommended isolation distance between portable and mobile radio-frequency communication equipment and the M5 portable bladder scanner M5 portable bladder scanner is expected to be used in electromagnetic environment where RF radiation disturbance is controlled.
Document No.: endix D Ultrasound Intensity and Safety C.1: Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises. There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound equipment.
Document No.: 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. During operation, the separation distance between user and the antenna shall be at least 20cm.
Document No.: Register by: Suzhou PeakSonic Medical Technology Co.Ltd. 2A, West Side of Building G4, Kunshan HiTech Medical Device Industrial Park, South Longsheng Rd and West Huangpujiang Rd,Qiandeng Town,Kunshan City,Suzhou City, Jiangsu Prov. Manufactured by: SUZHOU LISCHKA MEDTECH CO., LTD. 2F,BuildingG4,Kunshan Hi-Tech Medical Device Industrial Park NO.
Document No.: Attachment Engineering Automatic Calibration Instructions: The M series bladder scanner is patented in the fields of ultrasound imaging, measurement algorithm and probe. Therefore, the M series bladder scanner has the advantage of no calibration required during the service life in clinical application. We officially state that in the lifelong clinical application of the M series bladder scanner and the probe, as long as they are intact, then 1.
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Document No.: FCC Statement 15.19 Labeling requirements. 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. 15.21 Information to user. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
