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INTERSON Simpli GP-C01, Instructions For Use Manual

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INTERSON Simpli GP-C01 Instructions For Use Manual Download Page 40

Simpli Series System Instructions for Use 

40 

01-5034-00 R1 

Diagnostic Ultrasound Indications for Use 
Interson USB Ultrasound System 
Mode: B, B + color Doppler 
Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: 

 

GP-C01

 

SP-L01

 

Ophthalmic 

 

 

Fetal/Obstetric 

 

 

Abdominal 

 

 

Intra-Operative (Specify) 

 

 

Intra-Operative Neurological 

 

 

Laparoscopic 

 

 

Pediatric (excluding transcranial & neonatal) 

 

 

Small Organ (Scrotum, prostate, lymph nodes, thyroid, 
breast) 

 

 

Neonatal Cephalic 

 

 

Adult Cephalic 

 

 

Trans-rectal 

 

 

Trans-vaginal 

 

 

Trans-urethral 

 

 

Trans-esoph. (non-card.) 

 

 

Muscular-Skeletal (Conventional) 

 

 

Muscular-Skeletal (Superficial) 

 

 

Intravascular 

 

 

Other (Urology) 

 

 

Other (Gynecology) 

 

 

Other (Pelvic Floor) 

 

 

Other (Neuromuscular) 

 

 

Cardiac Adult 

 

 

Cardiac Pediatric 

 

 

Intravascular (Cardiac) 

 

 

Trans-esoph. (Cardiac) 

 

 

Intra-cardiac 

 

 

Peripheral vessel 

 

 

Other (Specify) 

 

 

 

 

 

Summary of Contents for Simpli GP-C01

Page 1: ...ument is subject to change without notice These Instructions For Use are applicable to the following SimpliTM Series probes GP C01 SP L01 Copyright Interson Corporation All rights reserved No part of...

Page 2: ...e Temperatures 8 Electromagnetic Compatibility EMC 9 Care and Handling of Probes 9 DO NOT OPEN ANY PROBE 9 DO NOT DISCONNECT OR REMOVE USB CABLE FROM THE PROBE 9 Maintenance 9 Cleaning and Disinfectio...

Page 3: ...20 Saving Images 20 Saving Cines 20 Imaging Tools 20 Annotation 21 Adding pointers 21 Measurements and Calculations 21 Statement of Accuracy 23 General Settings 24 Configuring Export Destination 24 Ed...

Page 4: ...terson Probes and Their Applications 32 Transducer Model GP C01 32 Transducer Model SP L01 32 Appendix E Summary of the Acoustic Quantities 33 Appendix F Achieving ALARA 37 ALARA Guidelines 37 Applyin...

Page 5: ...important instructions All users of the Interson Ultrasound Probe System must understand the meaning of these signal words These signal words and symbols and their meaning are as follows Signal Word M...

Page 6: ...Such adaptors should display certification of electrical safety testing If you are using a battery operated system you can disconnect the AC adapter to obviate this warning YWARNING Do not touch the U...

Page 7: ...n or unauthorized uses or disclosures of the information Symbology The following symbols may be used on Interson labeling Symbol for Serial Number REF Symbol for Part Number Symbol indicating the date...

Page 8: ...robe System supports B Mode mode scanning providing high resolution and high penetration performance The probes can be used in applications such as fetal heart abdomen OB GYN vascular extremity pediat...

Page 9: ...andling of Probes Although Interson probes are very durable reasonable care must be taken to avoid damaging them Handle the membrane on the tip of the probe and the cable attachment at the other end o...

Page 10: ...sheaths biopsy guide adapters and biopsy needle guides 4 Discard sheaths sheaths are a single use item in a biohazard container 5 Use a soft cloth lightly dampened in a mild soap or compatible cleani...

Page 11: ...e probe and void the warranty 1 Examine the probe for damage such as cracks splitting sharp edges or projections If damage is evident abandon disinfection discontinue use of the probe and contact a cu...

Page 12: ...package If the original package is not available contact Interson for the best packaging method prior to sending a probe in for evaluation and possible repair Disposal 1 Contact Interson Corporation...

Page 13: ...contain natural rubber and talc which can cause allergic reactions in some individuals For more information see the FDA s March 29 1991 Medical Alert on latex products Acoustic coupling gel must be us...

Page 14: ...5 Check for and eliminate bubbles between the face of the transducer and the sheath If any bubbles are present between the face of the transducer and the sheath the ultrasound image may be affected 6...

Page 15: ...xceed the following specifications Operating System Windows 7 10 Processor 2 5 GHz Memory 4 GB Storage 75 MB USB 2 0 port System Components The system consists of the following A commercial off the sh...

Page 16: ...n depth and frequency indicators and system controls Imaging Display 1 Navigation menu new exam enter patient information review exam settings help 2 Image area 3 Image information 4 Probe selection 5...

Page 17: ...the preset you want to edit and touch Controls Adjust the controls as desired and save the changes Refer to Optimizing the Image Note You can adjust the controls for the Default preset but you cannot...

Page 18: ...ontrast adjust the Contrast slider c To control the gain to the part of the image closest to the probe adjust the Near Gain slider d To control the gain to the middle part of the image adjust the Mid...

Page 19: ...structions for Use 19 01 5034 00 R1 2 To increase or decrease the image depth adjust the Depth selection slider 3 To increase or decrease the probe operating frequency touch a frequency you want from...

Page 20: ...ection and velocity of flow in the color box are represented with different colors for direction and different shades for velocity A color key is shown to the right of the image area 3 Touch CFM again...

Page 21: ...the location you want to place a pointer 3 Touch Pointer to stop pointers Measurements and Calculations Performing Distance Measurements 1 Distance measurement uses two calipers to measure the length...

Page 22: ...eehand measurements c Use 5 points measurement to define the area and circumference of a shape of best fit generated from five points placed on an image i Touch 5 points to begin 5 points measurements...

Page 23: ...the operator must be diligent in obtaining a good image Measurements should not be used as the sole determinant of diagnosis and treatment but should always be combined with other clinical data Vario...

Page 24: ...he left right orientation of the image touch Orientation Note The change will only take effect during live imaging or when image is unfrozen Inverting Image To invert the image touch Invert Image Note...

Page 25: ...thumbnail touch Load Images and select the image file you want to review The image will appear in the image area Imaging tools annotations pointers measurements and calculations are available during r...

Page 26: ...hown as a thumbnail navigate to the patient exam folder in File Explorer and delete the files Empty the Recycle Bin to permanently delete the files Exporting Images Cines and Reports All images cines...

Page 27: ...nger is already installed b For set up on an Android device follow the prompt to install VSee Messenger app from Google Play Skip this step if VSee Messenger is already installed c For set up on an iO...

Page 28: ...ct 4 Enter the email address of the contact you want to add and select ADD CONTACT Initiating a Call Session Either the remote user or the user running SimpliVue can initiate a call To initiate a call...

Page 29: ...py the installation file to your desktop or other location of your choice 4 Remove the flash drive and store it in a safe place 5 Go to the location where you saved SimpliVueArraySetup_v X Y Z exe 6 D...

Page 30: ...and 7 5 MHz nominal frequencies Depth Selections 2 cm through 24 cm depths Measurements Distance angle area circumference and volume measurements Signal Processing TGC controls near mid and far Contra...

Page 31: ...er Digital ports USB 2 0 port s Keyboard 83 keys or equivalent Mouse Touchpad USB mouse or equivalent AC Adapter Medical grade Battery Type PCGA BP2R or equivalent Operating System Windows 7 8 10 Soft...

Page 32: ...frequency is 5 0 MHz with upper and lower range ends of 7 5 MHz and 3 5 MHz respectively The operating modes are B and combined B color Doppler modes Transducer Model SP L01 This device is a hand hel...

Page 33: ...Zpi cm 1 63 fawf Fc MHz 3 65 3 65 3 65 Other Information prr Hz 5120 srr Hz 40 npps 1 Ipa at zpii W cm2 180 Ispta at zpii or zsii mW cm2 10 3 Ispta at zpii or zsii mW cm2 15 5 pr at zpii MPa 2 4 Opera...

Page 34: ...Ipa at zpii W cm2 180 Ispta at zpii or zsii mW cm2 10 3 Ispta at zpii or zsii mW cm2 7 73 pr at zpii MPa 5 13 Operating Control Conditions Scan rate 20 Hz B Mode Scan Angle 60 B Mode Scan Lines 128 C...

Page 35: ...5120 srr Hz 40 npps 1 Ipa at zpii W cm2 346 Ispta at zpii or zsii mW cm2 13 9 Ispta at zpii or zsii mW cm2 18 6 pr at zpii MPa 3 08 Operating Control Conditions Scan rate 40 Hz Lines per scan 128 Scan...

Page 36: ...at zpii W cm2 606 Ispta at zpii or zsii mW cm2 387 2 Ispta at zpii or zsii mW cm2 510 5 pr at zpii MPa 3 48 Operating Control Conditions Scan rate 20 Hz B Mode Scan Angle 3 84 cm B Mode Scan Lines 128...

Page 37: ...er level to set ALARA directs the operator to use the lowest possible acoustic power that still allows a diagnostic quality image to be obtained Using a higher transmit frequency results in lower biol...

Page 38: ...ltrasound has transitioned through fluid or soft tissue TIC informs the user of potential heating of bone at or near the surface TIS is used to indicate any heating effect in soft homogenous tissue If...

Page 39: ...sound imaging in B or Combined B Color modes It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications Fetal Obstetric Abdominal Pediatric Small Organ Mus...

Page 40: ...tive Specify Intra Operative Neurological Laparoscopic Pediatric excluding transcranial neonatal Small Organ Scrotum prostate lymph nodes thyroid breast Neonatal Cephalic Adult Cephalic Trans rectal T...

Page 41: ...t it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge IEC EN 61000 4 2 8 kV contact discharge 2 4 8 15kV...

Page 42: ...this symbol 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 reflectio...

Page 43: ...s will not exhibit excessive surface temperatures under normal use Disconnect the equipment if unsafe temperatures are observed Interson probes have been tested to conform with IEC 60601 2 37 Probe Ma...

Page 44: ...ity be if someone stole my laptop computer or storage device What would I do if my computer hard drive crashed Ultimately it is the user s responsibility to assure the security of their data Several s...

Page 45: ...ence Hadlock 1984 8 14 0 753 cm 0 0036 cm 2 Bi Parietal Diameter Hadlock 1984 9 54 1 482 cm 0 1676 cm 2 Bladder Volume 0 0285x 2 3 6624x 129 65 where x H W Bladder Volume 3D Poston et al 1983 0 7 x H...

Page 46: ...not extend to defects to i the Product arising out of material or workmanship not provided or furnished by the Company ii the Product resulting from abnormal use of the Product or use in any manner o...

Page 47: ...chased within 30 days of ownership To register your probes for an extended warranty copy this page fill out your information and send to Interson with payment Customer ________________________________...

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