Sentimag Instructions for Use

Copyrights and Trademarks Worldwide Patents Pending. Endomagnetics®, Endomag®, Sentimag® and Magseed® are registered trademarks of Endomagnetics Ltd. Magtrace® is a registered Trademark of Endomagnetics Ltd in the United Kingdom. Manufacturer Details Endomagnetics Ltd The Jeffreys Building Cowley Road, Cambridge CB4 0WS, UK

USA: Endomagnetics, Inc. 11 Centerville Road, Suite 400 Wilmington, DE 19808 Operating Precautions and Limitations of Use IMPORTANT: Endomagnetics Ltd’s products are designed for use by appropriately trained clinical staff in accordance with the supplied documentation.

IMPORTANT IT IS ESSENTIAL THAT THE USER OF THIS MANUAL IS AWARE OF THE POTENTIAL HAZARDS ASSOCIATED WITH THE INSTRUMENT AND ITS ACCESSORIES. ALL OPERATORS SHOULD BE FAMILIAR WITH THE SAFETY PRECAUTIONS AND WARNINGS GIVEN IN THIS SECTION BEFORE ATTEMPTING TO OPERATE THE INSTRUMENT. IF THE SYSTEM IS USED IN A MANNER THAT IS NOT SPECIFIED BY THE MANUFACTURER, THE PROTECTION PROVIDED BY THE EQUIPMENT MAY BE IMPAIRED. WARNING: NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.

II

The following symbols are used in this manual or on the instrument labels:

WARNING

CAUTION

BIOLOGICAL RISKS

CONSULT INSTRUCTIONS FOR USE

TYPE B APPLIED PART

ALTERNATING CURRENT

MANUFACTURER

CATALOGUE NUMBER

SERIAL NUMBER Includes year of manufacture and sequential build number

CE MARK

0086

CE mark for Medical Device as specified by the Medical Device Directive 93/42/EEC

FRAGILE. HANDLE WITH CARE

III

KEEP DRY

HUMIDITY LIMITATION

ATMOSPHERIC PRESSURE LIMITATION

TEMPERATURE RANGE

FOR USE BY, OR ON THE ORDER OF, A PHYSICIAN

IV

Operating Environment and Electrostatic Precautions WARNING: The instrument is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: equipment not suitable for use in the presence of flammable mixtures. WARNING: The Sentimag® probe should not be placed within 15 mm of any part of an operating pacemaker. WARNING: The Sentimag® probe should be removed from patient contact if there is requirement to use a defibrillator.

WARNING: The Sentimag® instrument should never be taken into an MRI environment. CAUTION: For best results, care should be taken when using the instrument in the proximity of extraneous metallic and/or magnetic objects, as they may generate confounding signals. This includes some, but not all, implantable manufactured materials such as artificial joints, limbs, prostheses, clips or stents; as well as some, but not all, ancillary objects and tools that may be encountered in the operating theatre environment, such as retractors, clamps, scalpels, reinforced tracheal tubes and theatre tables. If in doubt, the user should undertake an in situ assessment of the operating environment before using the instrument. CAUTION: Ensure cables and foot switch are positioned to prevent trip hazards. CAUTION: Avoid operating the instrument in direct sunlight, as this may affect its performance. Never leave the instrument or probe in direct sunlight, even when turned off.

CAUTION: Do not expose or operate the instrument in extremes of temperature (see Section 10), and minimise any exposure to electrostatic charges. CAUTION: For best results, operate the instrument in a stable (vibration-free) environment, with the base unit placed on a level working surface.

V

Instrument Power and Connector WARNING: To avoid risk of electric shock, this equipment must only be connected to a mains supply with protective earth. CAUTION: Never use any power adapter or cable other than the one specifically supplied with the instrument. See Section 10 for details.

CAUTION: Always replace any external fuse with the type and rating specified in Section 10. CAUTION: The Sentimag® system is disconnected through use of the Mains Switch on the back of the unit followed by the mains plug. Do not position the device such that it is difficult to carry out disconnection. CAUTION: Always switch the instrument off at the mains power outlet, before inserting or removing the power connector from the rear of the instrument. Failure to do so may damage the internal instrument electronics.

Base Unit Handling and Use CAUTION: Care should be taken not to drop the instrument base unit, or subject it to any form of rough physical handling, either during normal use or during storage and transportation.

Detachable Probe Handling and Use CAUTION: Care should be taken not to drop the detachable probe, or subject it to any form of rough physical handling, either during normal use or during storage and transportation. CAUTION: The detachable probe is not suitable for autoclaving or disinfection using formaldehyde, either of which action would result in serious damage to the probe. Autoclaving or formaldehyde-treating the detachable probe will void its warranty.

VI

CAUTION: In the unlikely occurrence of the probe becoming hot, all use of the Sentimag® system should cease and the unit sent for Service. Detachable Probe Connection and Use CAUTION: Refer to Section 2.8 for details on how to connect the detachable probe to the base unit, and ensure that the connectors are clean and dry before plugging them into the base unit. CAUTION: Care should be taken not to drop the detachable probe, or subject it to any form of rough physical handling, either during normal use or during storage and transportation. This includes not unduly bending or crushing the flexible cable that runs from the probe head to the connectors that plug into the base unit. Detachable Footswitch Connection and Use CAUTION: Refer to Section 2.9 for details on how to connect the air-operated footswitch to the base unit, and ensure that the connector is clean and dry before inserting it into the base unit. CAUTION: Care should be taken not to subject the detachable footswitch to any form of rough physical handling, both during normal use and during storage and transportation. This includes not unduly bending or crushing the air hose that runs from the foot-operated pad to the connector that plugs into the base unit. Instrument Casework and Serviceability CAUTION: Check the instrument before use for signs of damage, particularly to cables. If the instrument is damaged or gives unexpected performance or operation, then cease using the device and ensure that it is serviced before recommencing use of the device. CAUTION: There are no user-serviceable parts inside the instrument. Removal or opening of the instrument's case will void the warranty. Only Endomagnetics or their authorised and approved service agents/personnel to repair Sentimag® and its accessories.

VII

CAUTION: Never clean the instrument or probe using an excessively wet cloth, or by washing it under running water. Do not use solvents or other strong cleaning solutions as these will degrade the casework and affect instrument performance. Refer to Section 5.1 for details on how to clean and disinfect the instrument. CAUTION: It is recommended that an annual electrical safety test be performed in compliance with EN 62353:2008. Instrument Transport and Storage CAUTION: When not in use, the Sentimag® probe should always be securely stored in the supplied Case. Similarly, when being transported, the Sentimag® should always be securely packed

WEEE Directive Compliance

The Sentimag® instrument should be disposed of in accordance with the European Union WEEE Directive 2002/96/EC, on Waste Electrical and Electronic Equipment.

CAUTION: Do not dispose of this product into unsorted municipal waste or a public landfill. Please contact your local distributor for details of how to correctly dispose of this product.

VIII

Regulatory Limitations of Use The Sentimag® has been designed to meet the following general and safety requirements: General

•

Medical Device Directive 93/42/EEC and amendments up to and including 2007/47/EC

Safety

• • • • • •

IEC 60601-1:1988 including Amendments 1 and 2 IEC 60601-1:2005 + Corrigenda 2006 and 2007 UL 60601-1 CAN/CSA C22.2 60601-1-08 EN60601-1-2:2007 FCC Rules CF 47:2008 Part 15.107 and 15.109 Class B

The Sentimag® is manufactured under EN ISO 13485:2012 controls.

IX

Declaration of Conformity This is to certify that the Sentimag® conforms to the European Medical Device Directive 93/42/EEC with amendments up to and including 2007/47/EC, and as transposed into the national statutes and regulations of the United Kingdom. The device is subject to Notified Body Certificate no. CE 563405 under Annex II of 93/42/EEC issued by BSI (Notified Body no. 0086). The CE mark also means that the system compliant with RoHS directive 2011/65/EU. The device does not contain medicinal products, phthalates as defined in 2007/47/EC Annex 1, animal or human tissue, or derivatives thereof, and is not classified as machinery under Directive 2006/42/EC.

X

TABLE OF CONTENTS 1. Introduction ... 1 1.1 Sentimag® Features ... 2 1.2 Spare, Replacement or Additional Parts ... 3 1.3 Principle of Operation ... 3 1.4 Overview of Use ... 4 2. Installation and Basic Operation ... 6 2.1 Instrument Description ... 6 2.2 Transportation and Storage ... 9 2.3 Installation ... 10 2.4 Powering the Instrument ... 10 2.5 Turning the Instrument On ... 10 2.6 Turning the Instrument Off ... 10 2.7 Connecting the Probe Holder ... 11 2.8 Connecting the Probe Assembly ... 12 2.9 Optional: Connecting the Footswitch ... 13 3. Using the Sentimag® ... 14 3.1 Connecting the Probe ... 14 3.2 The Balance Function ... 14 3.3 Using the Footswitch ... 15 3.4 When to Use the Balance Function ... 16 3.5 Using the Speaker ... 16 3.6 Changing the Instrument Sensitivity Setting ... 17 3.7 Over-Range Signals ... 18 3.8 Signal Discrimination... 18 3.9 Sentinel Lymph Node Detection or Magseed® Tissue Marker Detection ... 19 4. Operator Maintenance ... 20 5. Cleaning and Disinfecting the Instrument ... 21 5.1 Cleaning of the Instrument ... 21 5.2 High-Level Disinfection of the Probe Head ... 22 6. Troubleshooting ... 24 6.1 Troubleshooting Tips ... 24 6.2 Instrument Error Codes ... 25 7. Instrument Warranty and Returns ... 27 7.1 Warranty Duration ... 27 7.2 Particular Exclusion ... 27 8. Certificate of Decontamination ... 28 8.1 Decontamination Declaration ... 29 9. Glossary of Terms and Abbreviations ... 30 10. Technical Specification ... 31 10.1 General Specifications ... 31 10.2 Performance and Accuracy ... 32 10.3 Magnetic Field Characteristics... 33 10.4 Electromagnetic Immunity and Separation ... 34

XI

1. Introduction The spread of some forms of cancer usually follows an orderly progression, spreading first to regional lymph nodes. Surgeons and clinicians need to identify and locate these so-called ‘sentinel’ nodes, in order that they may be surgically removed and studied by histology or molecular diagnostics (e.g. OSNA) to determine whether or not they have become secondary cancer sites. This is achieved by injecting some material or materials into the patient that concentrate in the sentinel node or nodes, which can be detected thereafter. The Sentimag® is designed for intra-operative use, to help the surgeon detect and locate sentinel lymph nodes where the material (or one of the materials) that is injected for the purpose of localisation is a magnetic tracer. The Sienna®/Magtrace® Product family is the magnetic tracer intended and calibrated for use with the Sentimag® device. It is the ONLY magnetic tracer approved under the Medical Device Directive 93/42/EEC for use in this application. In addition, the Sentimag® can be used to detect the Magseed® tissue marker which is intended to be placed percutaneously in the breast to mark a lumpectomy site intended for surgical removal. The Magseed® tissue marker is the magnetic marker intended and calibrated for use with the Sentimag® device. It is the ONLY magnetic marker approved under the Medical Device Directive 93/42/EEC for use in this application. The Sentimag® is a magnetic material sensor that is designed to detect small amounts of clinically introduced magnetic tracer or marker. It comprises a mains-powered base unit, a detachable hand-held probe that is connected to the base unit with a flexible cable of over two metres in length, and a detachable air-operated footswitch that is connected to the base unit with a flexible hose that is also over two metres in length. The sensing of the Sienna®/Magtrace® product family magnetic tracer or Magseed® magnetic marker is indicated by a change in pitch (frequency) of an audio output from the base unit, enabling the surgeon to move the hand-held probe around the area of the lymph nodes, and locate the sentinel node or nodes. A visible numerical representation of the detected signal level is simultaneously displayed on the base unit’s liquid crystal display and can be noted for the surgeon’s records. The hand-held probe is used in two modes: initial transcutaneous signal detection, and post incision use. The patient population for which the device is suited is not restricted by: Age, Weight, Health condition, Ethnic origin or Gender. The Sentimag® system is intended for use when the patient is anaesthetised. The probe contacts the skin and also tissue within the surgical site. The intended users are cancer surgeons or other appropriately qualified operating theatre staff trained in SLNB or lumpectomy procedures. The system is intended for use in operating theatres. The Sentimag® probe is to be used with a single-use sterile sheath, however the instrument is designed to provide a general ability to clean all external surfaces to a reasonable level of clinical cleanliness.

1

Please Note: The Sentimag® is intended for use by suitably qualified, trained and authorised surgeons and/or operating theatre staff. Endomagnetics Ltd takes no responsibility for the possible misuse of the Sentimag® – including attempted use with non-calibrated or non-approved magnetic tracers or markers - or for its use by inadequately qualified staff. This Operator’s Manual provides a detailed description of how to use the Sentimag®, and how to handle maintenance and troubleshooting. For any additional technical assistance, please contact your local distributor. 1.1 Sentimag® Features The main features of the Sentimag® are: ¨ Portable base unit that can sit on any flat surface ¨ Audible and visual indications of node proximity ¨ Audible signal with a variable pitch (frequency) that increases as the probe is brought near a lymph node containing Sienna®/Magtrace® product family or Magseed® magnetic tracer ¨ Volume control knob on the base unit ¨ Liquid crystal display (LCD) for numerical indication of signal strength ¨ Audible and visual discrimination between magnetic signals and extraneous or background signals ¨ Magnetic signals indicated by variable pitch (audible) and yellow LCD digits (visual); extraneous or background signals indicated by low and constant pitch (audible) and red LCD digits (visual) ¨ Choice of three sensitivity settings, controlled by a knob mounted on the base unit ¨ Instrument-balancing function that readies the system for measurement ¨ Push button mounted on the base unit activates the balance function ¨ Detachable air-operated footswitch allows remote operation of the balance function ¨ The Detachable Applied part is the probe assembly comprising a hand-held probe, a flexible cable of over two metres length, and colour-coded (black and white) connectors to plug the probe into the base unit ¨ Applied Probe assembly is to be used in conjunction with a standard single-use sterile sheath (sold separately by OEM suppliers)

2

1.2 Spare, Replacement or Additional Parts The Sentimag® is supplied complete and ready for use with a base unit, a probe assembly and a footswitch. Spare, replacement or additional probe assemblies, footswitches and mains cables may be purchased if desired: please contact your local distributor for details. From time to time Endomagnetics Ltd intends to make available for purchase new or specially tailored probe assemblies for use with the supplied base unit. Please contact your local distributor for details of such new releases. 1.3 Principle of Operation

PLEASE NOTE The Sentimag® is a highly sensitive and delicate measurement device. To avoid damage and degradation in performance, the instrument should be treated with the utmost care and respect at all times.

The Sentimag® is a very sensitive magnetic materials sensor. Technically speaking, the Sentimag® is a type of susceptometer. It is designed to deliver a small amplitude, time-varying magnetic field via a hand-held probe, and to electronically detect the presence of any magnetic materials in the vicinity of the probe head. This is done via pick-up coils in the probe head, which register a very small electrical current that is passed through the probe cables and connectors to the Sentimag® base unit. The base unit contains electronic circuits and a logical processor that interrogates the incoming signal from the probe, and converts this into both (1) an analogue signal that is passed to a loudspeaker mounted underneath the handle of the base unit, and (2) a digital signal that is displayed on the liquid crystal display on the front of the base unit. NOTE: The Sentimag® is best described as a proximity sensor – it is designed specifically for the purpose of detecting and locating small amounts of magnetic material by producing an audible and numerical signal that changes as the probe is brought closer to, or move further away from, the magnetic material. The numerical results on the Sentimag® liquid crystal display are not an absolute measure of the amount of magnetic material that is being sensed. Instead, they are a qualitative measure of the presence of magnetic material in the vicinity of the probe head.

3

1.4 Overview of Use

IMPORTANT Please ensure that you have read and understood all of the “Operating Precautions and Limitations of Use” at the beginning of this manual before continuing any further. A brief overview of how to use the Sentimag® is given below. Further details are provided in Section 2. Ideally, the probe should be connected to the unit before it is switched on. On switching on the base unit, the display will show an image of an unbalanced set of scales, , meaning that the unit is ready to be balanced. If the unit is switched on before the probe has been connected, a symbol indicating that the probe assembly needs to be plugged in will be displayed. Once the probe is plugged in, the display will revert to the symbol.

IMPORTANT Before application of anaesthetic to patient ensure Sentimag® device is switched on and is detecting metallic objects. At this point the operator should press the balance button on the base unit, marked with the symbol, which will cause the electronics within the base unit to set a baseline level for the magnetic measurements to follow. For best results the probe head should at this time be placed or held at least half a metre away from any metallic or magnetic objects, as otherwise an incorrect balance point will be recorded, and subsequent measurements will be unreliable. NOTE: During use, the balance point for the magnetic measurement may change or drift, e.g. as the electronics in the base unit warm up, or as the environmental conditions at the probe head change. This is normal. For best results, it is recommended that the base unit should be switched on at least 15 minutes before the first measurements are taken. Furthermore, from time to time it is advised that the operator should reset the measurement baseline by holding the probe head at least half a metre away from any metallic or magnetic objects, and re-pressing the balance button, . Alternatively, as the body is weakly dielectric, the user may find it beneficial to balance the unit whilst the probe is in contact with the body. This will result in a positive signal being generated when the probe is withdrawn from the body, but will have the advantage of returning to close to zero as it comes back in contact with the body. The Sentimag® is then ready for use. The operator may adjust the volume of the audible signal by turning the volume knob, marked .

4

The operator may also adjust the sensitivity level of the probe between three pre-set levels, by turning the sensitivity knob, marked . This applies a scaling factor to the measured signal such that the signal displayed on Setting 2 is twice that displayed on Setting 1. The signal displayed on Setting 3 is twice that displayed on Setting 2, and four times that displayed on Setting 1. It is largely a matter of operator preference as to which sensitivity setting is used, however, if the signal is small Setting 3 may give better results, and if the signal is large, Setting 1 may be preferred to avoid overloading the display limit.

5

2. Installation and Basic Operation 2.1 Instrument Description The Base Unit (front view) has the following external features:

1

2 5

3

6 4

7

Figure 1: Sentimag® Base Unit – Front View 1

Liquid crystal display

5

Sensitivity setting knob

2

Volume knob

6

Six-pin, colour coded (white), probe assembly port

3

Balance button

7

Eight-pin, colour-coded (black), probe assembly port

4

Footswitch port

6

The Base Unit (rear view) has the following external features:

1 4

2

5 3

Figure 2: Sentimag® Base Unit – Rear View 1

Built-in handle for carrying

4

Speaker grill

2

Unique model identification label

5

Mains power on/off switch

3

Mains power inlet socket

For details on how to connect the base unit with the mains power cable, the probe assembly, and the footswitch, please refer to Sections 2.4, 2.8 and 2.9 respectively.

7

The Probe Assembly has the following features: 2

4

3

1

Figure 3: Sentimag® Probe Assembly

1

Probe head

3

Six-pin base unit connector – colour coded with a white plastic ring

2

Flexible cable

4

Eight-pin base unit connector – colour coded with a black plastic ring

PLEASE NOTE From time to time Endomagnetics Ltd intends to make available for purchase new or specially tailored probe assemblies for use with the supplied base unit. If you have such a speciality probe assembly, it may appear different from the one shown in Figure 3. However, the basic elements of probe head, flexible cable and colour coded (black and white) connectors will remain the same.

8

The Footswitch Assembly has the following features:

Figure 4: Sentimag® Footswitch Assembly 1

Foot-operated switch

2

Flexible air hose

3

Base unit connector/valve

2.2 Transportation and Storage Whenever the instrument is moved from one location to another, ensure first that it has been correctly shut down to protect the internal mechanisms. Please refer to Section 2.6 for details. To prevent any possible damage during transportation, the instrument should be securely packed, with all accessories stored in the supplied accessories box. WARNING: Always ensure that the instrument, power adapter and any peripherals or cables are clean and free of any potentially hazardous or infectious substances before moving or transporting them. Refer to Section 5.1 for the recommended decontamination procedure.

9