Neodynamics Neonavia User Manual
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Neodynamics Neonavia User Manual

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  • Page 1 User Manual neonavia®...

  • Page 3: Table Of Contents

    To install NeoNavia biopsy system............................13 Operation........................................16 To prepare for biopsy....................................16 To perform a biopsy....................................17 To turn off the NeoNavia biopsy system and disassemble the probe after biopsy..25 Maintenance......................................27 To clean and inspect the base unit............................27 To do an electrical safety test..............................28 To maintain the driver.....................................28...

  • Page 4: Introduction

    The CorePulse ™ , FlexiPulse ™ and VacuPulse ™ probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination. The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.

  • Page 5: Manufacturer Information

    Manufacturer information Contact us at: Information Manufacturer Address Send a letter to note your specific area of in- NeoDynamics AB terest. Lejonvägen 14 Please include your customer name and ac- SE-181 32 Lidingö count number, your contact information and Sweden your question.

  • Page 6: Safety Information

    If components that are intended for single patient use only are used again, it can result in infection or injury of the patient. • Do not use NeoNavia biopsy probes if the sterile package is broken or damaged or if the Use by date has passed. •...

  • Page 7: Cautions

    Before using NeoNavia adjacent to ultrasound equipment, make sure to verify normal operation by following the instructions in 5.1. • Make sure that the driver cable is secure when moving NeoNavia. A loose cable can trip the operator. • Do not submerge or spray liquids directly on any parts of the NeoNavia biopsy system.
  • Page 8 • Base unit medical devices. 0413 • Driver • Probes Medical Device • Base unit • Driver • Probes Consult operating instructions • Base unit • Driver • Probes Manufacturer • Base unit • Driver • Probes neonavia user manual...
  • Page 9 • Base unit WEEE • Driver This way up • Base unit Follow the instructions for use • Probes Quantity of products included in the box • Probes Lot number • Probes Do not use if damaged • Probes neodynamics...
  • Page 10 Symbol Description Where Refer to the NeoNavia biopsy system • Probes user manual The sterile package contains 1 probe • Probes (REF# 2102, 2103 or 2104) Sterilized using ethylene oxide • Probes STERILE EO Use by date (YYYY-MM) •...

  • Page 11: Product Overview

    1 Base unit • 1 Holder • 1 Power cord (length: 3 m) • 1 NeoNavia biopsy system user manual Driver delivery The items in the list below are included in the delivery of the driver, REF# 1103: • 1 Driver •...

  • Page 12: Driver - Overview

    Driver – overview Driver status indicator Release buttons Light button Pressurized air connector Sampling button Vacuum connector Pulse button Electrical connector Light Probes – overview 3.4.1 CorePulse – overview Sampling needle Fastener Protective sleeve neonavia user manual...

  • Page 13: Product Description

    Fastener Product description NeoNavia biopsy system incorporates pulse technology and is designed to obtain tissue samples from breast lesions or axillary lymph nodes for histological evaluation. The system is composed of a base unit, a driver and three different types of sterile single use probes.
  • Page 14 • The base unit supplies NeoNavia with power. • The driver is attached to the base unit and controls the operation of NeoNavia during the procedure. The base unit and the driver are non-sterile. • The probes are attached to the driver. The sampling needle on the probes is the Applied Part.

  • Page 15: Installation

    Atmospheric pressure, storage and transport 60 kPa to 106 kPa Power requirements NeoNavia must be connected to a supply mains with protective earth when it is operated. The operation voltage must be 220-240 VAC/50 Hz, single phase. For more information about electrical requirements, see 9.3.
  • Page 16 manual...
  • Page 17 4.3.2 To move and park NeoNavia 4.3.3 To connect NeoNavia to the wall socket Caution: Floors should be wood, concrete or ceramic Caution: Make sure not to tile. If floors are covered block the access to the with synthetic material, see appliance inlet.

  • Page 18: Operation

    Warning: Do not bend the sampling needle. If the sampling needle is bent, do not use the probe. Caution: Do not manually manipulate the probe before attaching it to the driver. The probe might become unusable. neonavia user manual...

  • Page 19: To Perform A Biopsy

    If the sampling needle is bent, do not use the probe. Caution: Do not use NeoNavia when the power cord is wound around the cover, handle or any other part of the base unit. Caution: Make sure that the driver cable is free from external pressure.
  • Page 20 0.5 seconds. In the manual Notice: A system self- this image is used to show when a long test is performed every press is needed. time NeoNavia starts up. If the system self- test is successfull the The light button On/Off button turns...
  • Page 21 Notice: Use manual power to insert the needle and to advance it into the suspicious lesion. If needed, use short taps on the pulse button to activate a short and controlled forward movement to push the needle into the lesion. neodynamics...
  • Page 22 Notice: To take more samples, repeat from step 2. 5.2.4 To use the FlexiPulse probe neonavia user manual...
  • Page 23 A long press on the sampling button can cause the sample to be ejected at the wrong time. Notice: To take more samples, repeat from step 2. Notice: Blood in the transparent vacuum canister indicates bleeding at the sample site. neodynamics...
  • Page 24 If needed, use short taps on the pulse button to activate a short and controlled forward movement to push the needle into Notice: To take more the lesion. samples, repeat from step 3. neonavia user manual...
  • Page 25 Notice: Blood in the transparent vacuum canister indicates bleeding at the sampling site. neodynamics...
  • Page 26 3. short and controlled forward movement to push the needle into the lesion. Notice: Blood in the transparent vacuum canister indicates bleeding at the sampling site. neonavia user manual...

  • Page 27: To Turn Off The Neonavia Biopsy System And Disassemble The Probe After Biopsy

    To turn off the NeoNavia biopsy system and disassemble the probe after biopsy Warning: Use applicable personal protective equipment following local guidelines (for example gloves), during operation and maintenance of NeoNavia, to prevent exposure to biohazards. Notice: WhenNeoNavia it is turned off, a fan will continue to run.
  • Page 28 Notice: The On/Off button puts NeoNavia into stand-by mode. To disconnect NeoNavia completely, remove the power cable from the appliance inlet. Discard the probe as referred to in local laws and regulations. neonavia user manual...

  • Page 29: Maintenance

    Clean the base unit and visually inspect it for damage after each procedure or as required. Warning: Do not submerge or spray liquids directly on any parts of the NeoNavia biopsy system. Notice: The cleaning solution could be soap and water, detergent...

  • Page 30: To Do An Electrical Safety Test

    Electrical safety testing should be performed at intervals no greater than 12 months, using a standard medical safety analyzer. Please contact NeoDynamics AB if you need additional information on how to perform the electrical safety testing. To maintain the driver Keep a record of when the current driver was installed.

  • Page 31: Troubleshooting

    Troubleshooting Notice: Please report product related problems to NeoDynamics AB. See chapter for contact information. To troubleshoot NeoNavia biopsy system The base unit On/Off button status indicator does not light up when I press the On/Off button. Possible cause: NeoNavia is not powered.
  • Page 32 The driver is not properly connected. Corrective action: Make sure that the driver is properly con- nected. See chapter 4.3.1. Possible cause: There is no probe attached to the driver. Corrective action: Connect the selected probe. See chapter 5.1.2. neonavia user manual...
  • Page 33 See chapter 5.2.5. The system is safe to use. If the issue remains, please contact a NeoDynamics AB representative. See chapter for contact information. The base unit On/Off button status indicator is green but pulses are not activated when the pulse button is pressed.
  • Page 34 The base unit On/Off button status indicator is green but pulses are not activated when the pulse button is pressed. Possible cause: NeoNavia biopsy system is not working properly. Corrective action: Contact a NeoDynamics AB representative. See chapter for contact information.
  • Page 35 Inspect the driver cable from the base unit to the driver to make sure that there is no permanent damage. If there is damage to the cable, contact a NeoDynamics AB representative. See chapter for contact information. If there is a used probe attached, in- spect the probe for any signs of dam- age.
  • Page 36 If the issue remains, please contact a NeoDynamics AB representative. See chapter for contact information. The base unit On/Off button status indicator is not lit, but NeoNavia is turned on (indica- ted by sound). Possible cause: The status indicator does not work.

  • Page 37: To Troubleshoot The Driver

    Corrective action: Dispose of the probe per instruction and se- lect a new probe to continue the procedure. neodynamics...
  • Page 38 Pulses are only available when the CorePulse probe is unloaded/closed. The driver status indicator is yellow. This is not an error but an indication that the CorePulse probe is loaded/open for sampling. See chapter 5.2.3 for information on the complete sequence. neonavia user manual...

  • Page 39: To Troubleshoot The Flexipulse Probe

    Corrective action: Manually push the white sledge com- ponent forward until it locks in place. Try to connect the driver again. If the issue remains, dispose of the probe per instruction and select a new probe to continue the procedure. neodynamics...
  • Page 40 The driver status indicator is yellow. This is not an error but an indication that the FlexiPulse sampling sequence is still ongoing. See chapter 5.2.4 for information on the complete sequence. neonavia user manual...

  • Page 41: To Troubleshoot The Vacupulse Probe

    Manually push the white sledge com- ponent forward until it locks in place. Try to connect the driver again. If the issue remains, dispose of the probe per instruction and select a new probe to continue the procedure. Se 8.1. neodynamics...
  • Page 42 Select a new probe to con- tinue the procedure. The driver status indicator is yellow. This is not an error but an indication that the VacuPulse sampling sequence is still ongoing. See chapter 5.2.5 for information on the complete sequence. neonavia user manual...

  • Page 43: Recycling

    Recycling To recycle the NeoNavia biopsy system Follow the instructions below when you take NeoNavia out of service for decommission or disposal: Make sure that base unit and driver is cleaned as referred to in chapter 6.1. Do not discard the base unit or driver. It should be returned to the manufacturer. See chapter for contact information.

  • Page 44: Technical Data

    EMC information provided below. NeoNavia is intended for use in the electromagnetic environment specified below. The customer or the user of NeoNavia should assure that it is used in an environment that complies with the specifications. Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
  • Page 45 Electromagnetic immunity – guidance and manufacturer's declaration NeoNavia is intended for use in the electromagnetic environment specified in the next section. The customer or the user of the NeoNavia should assure that it is used in an environment that complies with the specifications.
  • Page 46 NeoNavia is intended for use in the electromagnetic environment specified below. The customer or the user of NeoNavia should make sure that it is used in an environment that complies with the specifications.
  • Page 47 Table 5: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity to proximity fields from RF wireless communications equipment (additional compliance levels) Test fre- Band Service/Application Modulation Maxi- Dis- quency tance munity power test Level 400 MHz 400 – 470 TETRA Pulse modu- 27 V/m lation 18 Hz 423 MHz neodynamics...
  • Page 48 Pulse modu- 54 V/m lation 217 Hz 910 MHz RFID Pulse modu- 54 V/m lation 217 Hz 960 MHz RFID Pulse modu- 54 V/m lation 217 Hz 2450 MHz RFID Pulse modu- 54 V/m lation 217 Hz neonavia user manual...
  • Page 49 manual...
  • Page 50 neodynamics...
  • Page 51 0413 Document number: NEODYNAMICS-012-001-EN Publication date: 2020-08-25 neodynamics...
  • Page 52 NeoDynamics AB Lejonvägen 14 SE-181 32 Lidingö, Sweden www.neodynamics.com...

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