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001118v4.0 - US EN

Sirius Medical Systems

Sirius Pintuition Detector

Instructions for Use

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8.3

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:

[email protected]

Содержание Pintuition Detector

Страница 1: ...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...

Страница 2: ...001118v4 0 US EN Sirius Medical Systems Sirius Pintuition Detector Instructions for Use 2 32 This page is left intentionally blank ...

Страница 3: ...ipment Push the calibrate button and release Hold the probe still The calibration takes approximately 5 seconds When to calibrate Before each new patient and when the system indicates it No signal Gently palpate push the tissue with the probe to reduce the distance between Pintuition Probe and Seed Sterility The Pintuition Probe is not a sterile medical device Always cover with a new legally marke...

Страница 4: ...001118v4 0 US EN Sirius Medical Systems Sirius Pintuition Detector Instructions for Use 4 32 This page is left intentionally blank ...

Страница 5: ...Off 16 4 USING THE PINTUITION DETECTOR 17 4 1 Connecting the Pintuition Probe 17 4 2 Calibrating the Pintuition Detector 17 4 3 System Test Using the Test Kit 18 4 4 Adjusting the volume 18 4 5 Application of sterile sheath 18 4 6 Detection Directionality and Accuracy 19 4 7 Surgical Procedure 20 4 7 1 Preparing the Procedure 20 4 7 2 Preoperative Surgical Planning no sterile area 20 4 7 3 Preoper...

Страница 6: ...ector are surgeons or other appropriately qualified operating theatre staff The System is intended for use in operating theatres Warning The Pintuition Detector is intended for use by suitably qualified and trained surgeons and or operating theatre staff Sirius Medical Systems takes no responsibility for the possible misuse of the Pintuition Detector or for its use by inadequately qualified staff ...

Страница 7: ...ition Seed during surgery The principle of operation is magnetism The Pintuition Probe contains sensitive sensors which measure the magnetic field The Base Unit processes these measurements and provides the distance from the Probe to the Pintuition Seed using visual and audible feedback The detected distance is shown in millimeters on the display and the audio feedback changes dependent upon the d...

Страница 8: ...calibration it is also visible on the of the Pintuition Base Unit This symbol indicates a fuse This symbol indicates that the device is intended for Prescription Use only 2 SAFETY This section contains important safety information It is required that the user has read and understood all warnings cautions and the complete Instructions for Use manual prior to using the Pintuition Detector 2 1 WARNIN...

Страница 9: ...d Pintuition Probe before cleaning Warning Do not attempt to perform service or maintenance while the Pintuition Detector is in use Warning Do not pour cleaning liquids over into or onto the Pintuition Base Unit Warning Do not connect a wet Pintuition Probe to the Pintuition Base Unit Warning Always check the instrument before use for signs of damage If the instrument is damaged or gives unexpecte...

Страница 10: ...g either during normal use or during storage and transportation If the Probe is dropped confirm correct functioning each with the supplied Test Kit following the System Test Procedure Caution Care should be taken not to drop the Pintuition Base Unit or subject it to any form of rough physical handling either during normal use or during storage and transportation If the Pintuition Base Unit is drop...

Страница 11: ...eed 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 Caution The Pintuition Base Unit is disconnected th...

Страница 12: ...tempt 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 Cleaning and Disinfection Contact Sirius Medical Systems if anything is damaged or defective 3 2 DEVICE DESCRIPTION 3 2 1 PINTUITION BASE UNIT FRONT Figure 1 Pintuition Base Unit Front ID Item Descrip...

Страница 13: ...on inlet for electrical power cord see Section 3 5 Powering the Device 9 Product Label Pintuition Base Unit Provides information on the Pintuition Base Unit 3 2 3 PINTUITION BASE UNIT DISPLAY INTERFACE Figure 3 Pintuition Base Unit Display Interface ID Item Description 10 Distance Measure Distance towards implanted seed in millimeters 11 Pintuition Probe identifier Identification of correctly conn...

Страница 14: ...or To connect Pintuition Base Unit with Pintuition Probe see Section 4 1 Connecting the Pintuition Probe 3 2 5 PINTUITION TEST KIT Figure 5 Pintuition Test Kit 3 2 6 AUDIO The Base Unit generates different audible tones according to the table below ID Item Description A1 Startup A beep is generated to indicate successful startup and successful connection of Probe after startup ID Item Description ...

Страница 15: ...normal operation in the configuration in which it will be used 3 5 POWERING THE DEVICE Warning The Base Unit must be properly grounded to ensure patient safety To avoid the risk of electrical shock this equipment must only be connected to mains supply with protective earth To avoid electrical shock plug the power cord into a properly wired receptacle use only the power cord supplied with the Base ...

Страница 16: ... Please see section 4 1 Connecting the Pintuition Probe for instructions 3 7 TURNING THE DEVICE OFF To turn the instrument off 1 Push the Power Switch 6 at the back of the Base Unit from the 1 position to the 0 position The Base Unit display 2 will go black and the system will shut down 2 Unplug from power supply The Base Unit can now be safely transported and stored ...

Страница 17: ... Probe until the display 2 shows that the Probe has been correctly connected in the right bottom corner 11 If a problem persists see Section 8 Troubleshooting Figure 7 Display info when the Probe is correctly connected left and not correctly connected right 4 2 CALIBRATING THE PINTUITION DETECTOR Caution Calibrate the Pintuition Detector before each clinical use and when the device provides unexpe...

Страница 18: ...d the Probe with Test Kit in the air 4 The base unit display 2 provides a distance in millimeters 4a If the distance on the display 2 deviates less than 2mm acceptable range 18 22mm from the distance indicated on the Test Kit label 18 the system is performing correctly 4b If the detected distance deviates more than prescribed please repeat the System Test procedure If the problem persists see Sect...

Страница 19: ...s up to 50mm The Pintuition Detector provides detection feedback in millimeters towards the implanted 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 20 mm 1mm 20 30 mm 2mm 30 40 mm 4mm 40...

Страница 20: ...tructions Section 4 4 Adjusting the volume and that the Display 2 is clearly legible 4 7 2 PREOPERATIVE SURGICAL PLANNING NO STERILE AREA 1 Apply the Probe 13 tip to the skin near the location of the tissue of interest Scan the Probe tip over the area until a stable signal is obtained 2 When a signal is obtained the display 2 will show the distance between the Probe tip and Pintuition Seed and the...

Страница 21: ...f a flammable anesthetic mixture with air or with oxygen or with nitrous oxide Warning Do not touch the Pintuition Probe connector port contacts and the patient simultaneously 1 Use the Pintuition Detector as many times as necessary during surgery as a guidance towards the tissue of interest 2 Perform an excision of the tissue of interest that is marked with the Seed 3 Confirm presence of the Seed...

Страница 22: ...hazardous waste procedures 1b If the Seed is not encountered during pathological processing it can be safely stored within the specimen Note It is not mandatory to search for and remove the Pintuition Seed from the specimen during pathological processing 4 8 DISCONNECTING THE PROBE The Probe connector 16 is outfitted with a locking mechanism to prevent accidental disconnection of the Probe during ...

Страница 23: ...s or other materials that could scratch the panels or damage the Base Unit 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 5 2 PINTUITION PROBE Manufacturer Sirius Medical Systems Device Pintuition Probe INSTRUCTIONS Initial trea...

Страница 24: ...EEK plastic Perform high level disinfection using a legally marketed high level disinfection agent suitable for medical plastics For example use manual immersing into a low foaming 2 4 glutaraldehyde solution or at least 1 000 ppm peracetic acid solution2F2F 3 Follow the manufacturer s instructions with regards to concentration temperature pH value water quality expiration date and contact time to...

Страница 25: ...r Packaging No particular requirements Sterilization Warning The Pintuition Probe including cable is not suitable for sterilization Storage No particular requirements Additional Information Warning Always apply a suitable and legally marketed sterile sheath before using the Pintuition Probe in a sterile field The Pintuition Probe is only intended to have tissue contact with the intact skin prior t...

Страница 26: ...e fuse is accessible through the fuse cover 7 If the fuse is blown a technician or other sufficiently trained user can replace the fuse 6 3 REPAIRS Warning No modification of this equipment is allowed do not open or repair the Pintuition Base Unit or Pintuition Probe Opening may expose dangerous electrical components Always contact Sirius Medical Systems for service The Pintuition Detector has no ...

Страница 27: ...range 90 non condensing Protection against electrical shock Class I Protectively Earthed Service life 5 years Pintuition Base Unit Dimensions W x H x D 26 x 16 x 32 cm 10 2 x 6 3 x 12 6 in Weight 6 kg 13 2 lbs Ingress protection IP3X Power Lead Connector IEC 60320 C13 Rated input 100 240 V AC 50 60 Hz 1 2A Fuse type and Dimensions Ø x L T3 15AH 250 V 5 mm x 20 mm 0 2 x 0 8 in Pintuition Probe Appl...

Страница 28: ...al operation in the configuration in which it will be used Caution The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to ta...

Страница 29: ...ation during power mains interruption it is recommended that the Pintuition detector be powered from an uninterruptible power supply or a battery Voltage interruptions IEC 61000 4 11 0 UT 250 300 cycle 0 UT 250 300 cycle Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercia...

Страница 30: ...nting or relocating the Pintuition detector Note 4 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distance between Portable and Mobile RF Communications Equipment and the Pintuition detector The Pintuition detector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customers or the ...

Страница 31: ...sound System is muted Adjust the volume see Section 5 4 Speaker not functioning N A Restart Base Unit system should produce audio on start up Base unit not responding or locked inoperable Interference by electromagnetic radiation Non responsive Increase distance between other electrical devices and Detector and 1 Reconnect Probe or 2 Restart Base Unit Base unit does not show Probe connected Probe ...

Страница 32: ...nstructions for Use 32 32 8 3 OBTAINING TECHNICAL ASSISTANCE 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 ...

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