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Sirius Pintuition Detector
Instructions for Use
This document covers:
Sirius Pintuition Base Unit (SPBU)
Sirius Pintuition Probe (SPP)
Sirius Pintuition Test Kit (SPTK)
Version: 001118v4.0
Made in the Netherlands.
Sirius Medical Systems B.V.
High Tech Campus 41
5656 AE Eindhoven
The Netherlands
Contact:
support@sirius-medical.com
URL: www.sirius-medical.com.
Copyright © 2021 Sirius Medical Systems
All rights reserved. No part of this Instruction may be reproduced, stored in a retrieval system, or
transmitted, by any means or in any form, without the prior permission of Sirius Medical Systems B.V.
Sirius Medical Systems assumes no responsibility for any errors that may appear in this document.
Worldwide Patents Pending.
001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
1/32
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Summary of Contents for Sirius Medical Pintuition Detector
- Page 1 All rights reserved. No part of this Instruction may be reproduced, stored in a retrieval system, or transmitted, by any means or in any form, without the prior permission of Sirius Medical Systems B.V. Sirius Medical Systems assumes no responsibility for any errors that may appear in this document.
- Page 2 This page is left intentionally blank. Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 2/32 Instructions for Use...
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Page 3: Quick Reference Guide
Warning! This sheet is not intended as a replacement of the complete Instructions for Use. Please read the complete Instructions for Use booklet supplied with the Pintuition Detector and Pintuition Probe before first use, or refer to www.sirius-medical.com/support for the latest version. - Page 4 This page is left intentionally blank. Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 4/32 Instructions for Use...
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Page 5: Table Of Contents
Explanation of Symbols .......................... 7 SAFETY ............................8 Warnings ..............................8 Cautions ..............................10 INSTALLATION AND BASIC OPERATION OF THE PINTUITION DETECTOR ...... 12 Unpacking and Inspecting ........................12 Device Description ..........................12 3.2.1 Pintuition Base Unit - Front ..........................12 3.2.2... -
Page 6: Introduction
This Instructions for Use provides a detailed description of how to use the Pintuition Detector and how to perform maintenance and troubleshooting. It is mandatory to read these entire instructions for use, prior to using the Pintuition Detector. NDICATION FOR The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (<... -
Page 7: Possible Complications And Adverse Events
Use of other parts is not allowed. RINCIPLE OF PERATION The Pintuition Detector is an electrical medical device, intended to detect the presence and distance towards a Sirius Medical Systems certified magnetic implant (such as the Pintuition Seed) during surgery. -
Page 8: Safety
Instructions for Use may pose a potential hazard to the patient and/or user. Warning. Do not use the Pintuition Detector in other tissues than named under “Indications for Use”. Do not use in the central nervous system, vascular system, heart, lung, eyes, brain or in tissue that is clinically proven to be infected. - Page 9 Pintuition Detector. Warning. The Pintuition Detector should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Pintuition Detector shall be observed to verify normal operation in the configuration in which it will be used.
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Page 10: Cautions
5 mm of the seed. Warning. The Pintuition Detector is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide. - Page 11 The user might need to take mitigation measures, such as relocating or re- orienting the equipment. Caution. In the unlikely event that the Pintuition Detector is locked inoperable during use due to electromagnetic disturbances from other devices, disconnect and reconnect the Pintuition Probe. Make sure the distance to the other device including any cables is enlarged.
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Page 12: Installation And Basic Operation Of The Pintuition Detector
Carefully inspect each item as it is unpacked for any signs of damage that may have occurred during shipment. Do not attempt to set up the Pintuition Detector if anything is damaged or defective. It is recommended to clean and disinfect the Probe before first use according to the instructions in Section 5 (Reprocessing –... -
Page 13: Pintuition Base Unit - Back
Distance towards implanted seed in millimeters Pintuition Probe identifier Identification of correctly connected and functioning Pintuition Probe Volume status Identification of volume status (on or muted and current volume). Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 13/32 Instructions for Use... -
Page 14: Pintuition Probe (Applied Part, Type Bf)
The Base Unit generates different audible tones according to the table below. Item Description Startup A beep is generated to indicate successful startup and successful connection of Probe after startup. Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 14/32 Instructions for Use... -
Page 15: Transport And Storage
Refer to Section 7 (Technical Specifications) for environmental limitations of use. Warning. The Pintuition Detector should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Pintuition Detector needs to be observed to verify normal operation in the configuration in which it will be used. -
Page 16: Turning The Device Off
The Base Unit display (2) will go black, and the system will shut down. Unplug from power supply. The Base Unit can now be safely transported and stored. Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 16/32 Instructions for Use... -
Page 17: Using The Pintuition Detector
ONNECTING THE INTUITION ROBE To use the Pintuition Detector, the Probe must be connected to the Base Unit: Align the white arrow on the connector (16) with the white arrow on the Probe connector port (5). Gently push the connector into the port until a locking click is felt. -
Page 18: System Test: Using The Test Kit
The Pintuition Detector is supplied with a Pintuition Test Kit (17). The Pintuition Test Kit (17) contains a Pintuition seed at a fixed and predetermined distance of 20 mm. The device can be used to confirm correct functioning of the Pintuition Detector. To perform the System Test, see Figure 9: Calibrate the Detector following the instructions in Section 4.2 (Calibrating the... -
Page 19: Detection, Directionality And Accuracy
Pintuition Seed. The Pintuition Detector has a detection distance up to 50 mm. The Pintuition Detector has a detection accuracy that is dependent upon the distance between the Seed and the Pintuition Probe, according to the following table: Distance (mm) Accuracy 0 –... -
Page 20: Surgical Procedure
Caution. Care should be taken to remove all magnetic disturbances from the vicinity of the Probe during routine use. Caution. Always calibrate the Pintuition Detector before each use by following the instructions in Section 4.2 (Calibrating the Pintuition Detector). Note. The calibration procedure may be repeated during use if the system provides insufficient detection range. -
Page 21: Perioperative - During Surgery (Use Within Sterile Area)
If multiple seeds are required, space them sufficiently apart and/or proceed with care. Warning. The Pintuition Detector is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide. -
Page 22: Disconnecting The Probe
Grasp the connector (16) between thumb and index finger. Gently pull the connector towards you in the direction of the white arrow on the connector (16). Figure 11: Disconnecting the probe. Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 22/32 Instructions for Use... -
Page 23: Reprocessing - Cleaning And High Level Disinfection
Clean for example using a damp cloth with water, a legally marketed medical device certified cleaning agent or at maximum 70% isopropyl alcohol. The Base Unit is not compatible with automated cleaning and/or sterilization. INTUITION ROBE Manufacturer: Sirius Medical Systems Device: Pintuition Probe INSTRUCTIONS Initial treatment No particular requirements. - Page 24 Warning. Do not immerse the Probe tip beyond the white part. Such as Ecolab Incidin™ Oxyfoam S or Ecolab Incidin Oxywipe S Such as Schuelke Microzid® PAA wipes Such as Ecolab Sekusept™ Aktiv Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 24/32 Instructions for Use...
- Page 25 See Section 8.3 - Obtaining Technical ASSISTANCE. contact The instructions provided above have been validated by Sirius Medical Systems as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials, and personnel in the processing facility, achieves the desired result.
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Page 26: Maintenance And Service
Always contact Sirius Medical Systems for service. The Pintuition Detector has no user-serviceable internal components other than the fuse. Try to resolve any maintenance issues with the Pintuition Detector by using the table in Section 8 (Troubleshooting). If you are unable to resolve the problem, contact Sirius Medical Systems, see contact information in Section 8.3 (Obtaining Technical Assistance). -
Page 27: Technical Specifications
This product has been designed in accordance with the following standards on electrical safety: • IEC 60601-1 (Edition 3.1). • IEC 60601-1-2 (Edition 4). The Pintuition Detector has no essential performance according to the IEC 60601-1 (Edition 3.1) definition. Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 27/32... -
Page 28: Electromagnetic Compatibility
Guidance and manufacturer’s declaration – electromagnetic emissions Pintuition detector is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in such an environment to prevent improper operation. - Page 29 Guidance and manufacturer’s Declaration – Electromagnetic Immunity Pintuition detector is intended for use in the electromagnetic environment listed below. The user of the device should assure that it is used in such an environment to prevent improper operation. Immunity Test IEC...
- Page 30 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pintuition detector is used exceeds the applicable RF compliance level above, the Pintuition detector should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Pintuition detector.
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Page 31: Troubleshooting
30 seconds and turn on the power. If the error persists, write down the error code and software version identifiers indicated on the main screen (see section 3.6 (Turning the Device On)) and contact Sirius Medical Systems or your local distributor for assistance. -
Page 32: Obtaining Technical Assistance
BTAINING ECHNICAL SSISTANCE For technical information and assistance, contact: Sirius Medical Systems B.V. High Tech Campus 41 5656 AE Eindhoven The Netherlands URL: www.sirius-medical.com/support Customer Service: support@sirius-medical.com Sirius Medical Systems 001118v4.0 - US EN Sirius Pintuition Detector 32/32 Instructions for Use...
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