UNEEG™ SUBQ

UNEEG™ SUBQUSER MANUAL SURGICAL PROCEDURE

USER MANUAL SURGICAL PROCEDURE | ENGLISH | 3

UNEEG™ SubQ

PRODUCT OVERVIEW

The 24/7 EEG™ SubQ (hereafter named device system) consists of implantable and non-implantable device parts (Figure A).

The implantable part, the UNEEG™ SubQ (hereafter named implant), measures the subcutaneous electroencephalogram (EEG) from two bipolar channels with a common reference.

It communicates with a non-implantable part, the 24/7 EEG™ SubQ (hereafter named device), which supplies the implant with

power, receives and stores recorded EEG. This runs through an inductive link (wireless), which requires a close transcutaneous align-ment between the device and the implant to function. In addition, the device measures and stores 3D acceleration to support future product development.

FIGURE A

UNEEGTM SubQ (Implant)

24/7 EEGTM SubQ(Device)

24/7 EEG™ Link(PC software)

4 | USER MANUAL SURGICAL PROCEDURE | ENGLISH

UNEEG™ SubQ

IMPORTANT: Additional warnings and pre-cautions may appear in this user manual.

WARNINGS • Seek medical guidance before entering

environments that could adversely affect the implant. This includes, but is not limited to:

- Hospital areas with restricted access for patients.

- High-power radio-frequency transmit-ters (e.g. military radar installations, radio/TV transmitters).

• The implant is not compliant with the fol-lowing medical procedures. The implant must be explanted before receiving any of the following treatments:

- MRI scan. The implant is MR unsafe. - Therapeutic ionizing radiation induced

close to the implant (e.g. radiation thera-py for cancer).

- Therapeutic ultrasound induced close to the implant.

- Electrical current induced close to the implant (e.g. electro knife, electro- convulsive therapy).

• The following medical procedures are safe to use with the implant:

- Diagnostic ionizing radiation (e.g. x-ray, CT).

- Diagnostic ultrasound.

WARNINGS AND PRECAUTIONS

PRECAUTIONSSubjects using the device should take note of the following:• The implant can be damaged if exposed

to physical impact. Do not take part in combat sports such as boxing, and wear a helmet in activities such as skiing, mountain bike riding, or horseback riding.

• The implant can be damaged if exposed to extreme pressure variations. Do not take part in extreme sport activities such as parachute jumping or diving deeper than 5 metres.

• In case the implant site has been exposed to physical injury, contact the responsible medical professional.

• Hold mobile phone to the opposite ear from the implant site.


UNEEG™ SubQ

1. INTRODUCTION . . . . . . . . . . . . . 6

1.1 Intended Use . . . . . . . . . . . . .6

1.2 Contraindications . . . . . . . . . .6

1.3 Side Effects . . . . . . . . . . . . . .7

1.4 Important Subject Information. . .7

2. DEVICE DESCRIPTION . . . . . . . . . 8

2.1 Device Parts . . . . . . . . . . . . .8

3. IMPLANT POSITIONING . . . . . . . . 9

4. IMPLANTATION PROCEDURE

(VERTICAL POSITION) . . . . . . . .10

4.1 Subject Preparation . . . . . . . . 10

4.2 Infiltration Analgesia. . . . . . . . .11

4.3 Creation of Subcutaneous Pocket . . . . . . . . . . . . . . . . .11

4.4 Insertion of Implant in Introducing Aid. . . . . . . . . . . 12

4.5 Electrode Insertion in Subgaleal Space . . . . . . . . . . 13

4.6 Implant Insertion in Subcutaneous Pocket . . . . . . . 14

4.7 Closure (Vertical Position) . . . . 14

CONTENT

5. IMPLANTATION PROCEDURE

(HORIZONTAL POSITION). . . . . . .16


5.2 Infiltration Analgesia. . . . . . . . 17

5.3 Creation of Subcutaneous Pocket . . . . . . . . . . . . . . . . 17

5.4 Insertion of Implant in Introducing Aid. . . . . . . . . . . 18

5.5 Electrode Insertion in Subgaleal Space . . . . . . . . . . 19

5.6 Implant Insertion in Subcutaneous Pocket . . . . . . 20

5.7 Closure . . . . . . . . . . . . . . . 20

6. EXPLANTATION PROCEDURE . . . . 21


6.2 Infiltration Analgesia. . . . . . . . 21

6.3 Removal of the Implant . . . . . . 21

6.4 Closure . . . . . . . . . . . . . . . 22

7. MAINTENANCE . . . . . . . . . . . . 23

7.1 Lifetime of Implant. . . . . . . . . 23

7.2 Disposal . . . . . . . . . . . . . . . 23

8. TECHNICAL DESCRIPTION . . . . . 24

9. SYMBOLS AND MARKINGS . . . . . 26

10. MEDICAL IMPLANT ID CARD . . . 27


UNEEG™ SubQ

1. INTRODUCTION

1.1 INTENDED USEMeasuring and recording of electrical activity of the brain (EEG) through electrodes implanted subcutaneously in the tissue be-tween the skull and the skin. Intended for subjects where single-location, continuous, ultra long-term (more than two weeks) EEG recordings are indicated to aid in monitoring and diagnosis of diseases or conditions that alter the EEG.

The intended users of the product are males and females, age 18 and above.

IMPORTANT: The surgeon is required to hold an MD with specialisation in a surgical area relevant for the implantation and explantation procedure, such as plastic surgery.

1.2 CONTRAINDICATIONSThe implant is not intended in case of any of the following:• Subjects with cochlear implant(s).• Subjects involved in therapies with medi-

cal devices that deliver electrical energy in the area around the implant.

• Subjects at high risk of surgical compli-cations, such as active systemic infection and hemorrhagic disease.

• Subjects who are unable (i.e. mentally or physically impaired patients), or do not have the necessary assistance, to proper-ly operate the device system.

• Subjects who have an infection at the site of device implantation.

• Subjects who operate MRI scanners.• Subjects with a profession/hobby that

includes activity imposing extreme pressure variations (e.g. diving or para-chute jumping). NB: diving/snorkelling is allowed to 5 metres depth.

• Subjects with a profession/hobby that includes activity imposing an unaccept-able risk for trauma against the device or the site of implantation (e.g. martial art or boxing).


UNEEG™ SubQ

1.3 SIDE EFFECTSGeneral side effects normally associated with any surgical implantation procedure or local anaesthesia also apply to the place-ment of the implant.

Specifically, the following side effects may be associated with implantation and use of the implant:• Formation of haematoma or seroma

near the implant site following the surgical procedure (for a period up to 3 weeks).

• Temporary pain, headache, infection and discomfort (including soreness, inflam-mation, swelling, irritation and itching) at the implant site following the surgical procedure (for a period up to 3 weeks).

• Skin ischemia potentially inducing ne-crosis at the implant site due to pressure and compromised local circulation.

• Infection, swelling, soreness, irritation or itching of the skin at the implant site.

• Occasional headache or pain during long-term use of the device

1.4 IMPORTANT SUBJECT INFORMATIONThe subject must be informed about the following:• Common post-surgery conditions,

including wound healing and treatment and symptoms of infection.

• That some soreness, pain, and/or head-aches are expected in the post-surgery period.

• The relevant warnings and precautions (see beginning of user manual).

• To always wear a completed medical implant ID card, e.g. in the wallet. See ‘10 MEDICAL IMPLANT ID CARD’.


UNEEG™ SubQ

2. DEVICE DESCRIPTION

2.1 DEVICE PARTSTABLE 1 summarises the supplied parts for use in the implantation procedure.

TABLE 1: PARTS SUPPLIED FOR USE IN THE IMPLANTATION PROCEDURE.

ImplantThe implant consists of the implant house and the electrode with a length of 100 mm. The implant is supplied sterile.*

Introducing aidFor insertion, a specialised needle (referred to as the introducing aid) is used. The introducing aid is supplied sterile.**

Electrode

House

Electrode

House

*ethylene oxide procedure; **electron beam radiation procedure

Shaft

HandleHandle

Shaft


UNEEG™ SubQ

3. IMPLANT POSITIONING

The implant consists of a house and an elec-trode, as seen in FIGURE B.The house is implanted subcutaneously be-hind the ear, and the electrode is placed sub-cutaneously within the blue area indicated by FIGURE C.

Instructions are provided for two suggested positions of the electrode:

1 Vertical Position – the electrode is di-rected approximately 30 mm posterior of the vertex cranii. This position can e.g. be used for monitoring hypoglycaemia- induced EEG changes. For implantation procedure with the Vertical Position, fol-low section ‘4 IMPLANTATION PROCE-DURE (VERTICAL POSITION)’.

2 Horizontal Position – the electrode is directed towards the temple. This position can e.g. be used for monitoring Mesial Temporal Lobe Epilepsy (MTLE). For im-plantation procedure with the Horizontal Position, follow section ‘5 IMPLANTATION PROCEDURE (HORIZONTAL POSITION)’.

3 Any other position – the electrode can be placed anywhere within the blue area on FIGURE C. Use either of the suggested procedures as a guide, but coordinate the position of the electrode with the responsible medical professional.

IMPORTANT: Always make sure to coordi-nate the position of the electrode with the responsible medical professional, including the appropriate variant of the implant with the desired electrode length.

FIGURE C

Electrode

House FIGURE B

Electrode

House

1

2 3

33

= Area for electrode implantation

= Position for house implantation

Area for electrode implantation

Position for houseimplantation


UNEEG™ SubQ

4. IMPLANTATION PROCEDURE (VERTICAL POSITION)

FIGURE D illustrates the vertical position of the implant. The implantation procedure is performed with surgical sterile technique (except 4.1). Antistatic, powder-free gloves must be applied.

4.1 SUBJECT PREPARATION (VERTICAL POSITION)1. The subject is put in a supine position.2. Inspect the postauricular area for any

signs of skin infection.3. Mark the position of the implant house

using a permanent ink pen, see FIGURE D. Implant house must be placed below hairline.

4. Mark the position of the electrode up to 80 mm in the direction approximately 30 mm posterior of the vertex cranii (FIGURE D).

5. Mark the position of a 25 mm incision be-hind the ear near the hairline. The incision should be placed approximately 10 mm from the implant house.

WARNINGS

• Pay careful attention to the “use by date” of the implant and the intro-ducing aid before use. Never use if exceeded.

• The implant and introducing aid are supplied sterile and are not to be reused. Single use only.

• Never try to re-sterilise the implant or the introducing aid.

• Never use the implant or the intro-ducing aid if the sterile pack of either one has been damaged or previously opened. In such case, the content must be disposed of.

FIGURE D

Vertex cranii

30 mm

10 mm

Electrode direction


UNEEG™ SubQ

4. IMPLANTATION PROCEDURE (VERTICAL POSITION) 4.2 INFILTRATION ANALGESIA (VERTICAL POSITION)1. Thoroughly cleanse the postauricular area

with chlorhexidine or similar. 2. Inject infiltration analgesia (lidocaine with

adrenaline or similar) subcutaneously in the subgaleal space. It should cover the entire implantation site, including the full length of the electrode around the implantation site.

4.3 CREATION OF SUBCUTANEOUS POCKET (VERTICAL POSITION)1. Make a 25 mm incision with a scalpel at

the marked position (FIGURE E). 2. Create a skin pocket for the implant house

by blunt dissection (FIGURE F).

FIGURE E

FIGURE F


UNEEG™ SubQ

4.4 INSERTION OF IMPLANT IN INTRO-DUCING AID (VERTICAL POSITION)1. Extract the implant and the introduc-

ing aid from the sterile packs, remove the safety cap, and position as depicted (FIGURE G).

2. Place the implant at the tip of the intro-ducing aid shaft (FIGURE H) and gently pull it towards the introducing aid handle, leaving the electrode inside the shaft. Use the index finger to keep the electrode in place (FIGURE I).

3. Place the implant house in the handle of the introducing aid. Make sure to insert the full length of the electrode, leaving the implant house as depicted (FIGURE J), resulting in the tip of the introducing aid shaft being extended approximately 1 mm from the distal end of the electrode.

4. Bend the introducing aid carefully to fit the curved shape of the subject’s skull (FIGURE K).

FIGURE G

FIGURE I

FIGURE H

FIGURE J

FIGURE K


UNEEG™ SubQ

4.5 ELECTRODE INSERTION IN SUB-GALEAL SPACE (VERTICAL POSITION)1. Insert the introducing aid in the subgaleal

space from the posterior end of the incision, and gently push it 80 mm in the direction approximately 30 mm posterior of the vertex cranii (FIGURE L + FIGURE M).

2. Lift the implant house slightly upwards and release it from the introducing aid.

3. Withdraw the introducing aid carefully, leaving the electrode in situ (FIGURE N).

FIGURE N

FIGURE L

FIGURE M


UNEEG™ SubQ

FIGURE O

FIGURE P

4.7 CLOSURE (VERTICAL POSITION)1. Close the incision in one layer with non-

resorbable sutures (FIGURE Q).

Care should be taken that any contact be-tween the sewing needle and the implant house or the electrode is avoided.

FIGURE Q

4.6 IMPLANT INSERTION IN SUBCUTA-NEOUS POCKET (VERTICAL POSITION)1. Place the implant carefully in the created

subcutaneous pocket (FIGURE O + FIGURE P).


UNEEG™ SubQ


UNEEG™ SubQ

5. IMPLANTATION PROCEDURE (HORIZONTAL POSITION)

FIGURE V illustrates the horizontal posi-tion of the implant. The implantation procedure is performed with surgical sterile technique (except 5.1 Subject Preparation). Antistatic, powder- free gloves must be applied.

5.1 SUBJECT PREPARATION (HORIZON-TAL POSITION)1. The subject is put in a supine position.2. Inspect the postauricular area for any

signs of skin infection.3. Mark the position of the implant house

using a permanent ink pen, see FIGURE R. Implant house must be placed below hairline.

4. Mark the position of the electrode hori-zontally approximately 60 mm in the direction of the temple, see FIGURE R.

5. Mark the position of a 25 mm incision behind the ear near the hairline. Shaving may be necessary in some cases, depend-ing on the hairline. The incision should be placed slightly off the centre of the planned subcutaneous pocket.

WARNINGS • Pay careful attention to the “use by

date” of the implant and the intro-ducing aid before use. Never use if exceeded.

• The implant and introducing aid are supplied sterile and are not to be reused. Single use only.

• Never try to re-sterilise the implant or the introducing aid.

• Never use the implant or the in-troducing aid if the sterile pack of either one has been damaged or previously opened. In such case, the content must be disposed of.

FIGURE R

Hair line

Temple

Subcutaneous pocket


UNEEG™ SubQ

5.2 INFILTRATION ANALGESIA (HORIZONTAL POSITION)1. Thoroughly cleanse the postauricular area

with chlorhexidine or similar. 2. Inject infiltration analgesia (lidocaine with

adrenaline or similar) subcutaneously in the subgaleal space. It should cover the entire implantation site, including the full length of the electrode around the implantation site.

5.3 CREATION OF SUBCUTANEOUS POCKET (HORIZONTAL POSITION)1. Make a 25 mm incision with a scalpel at

the marked position (FIGURE S).2. Create a skin pocket for the electrode

house by blunt dissection (FIGURE T).

FIGURE S

FIGURE T


UNEEG™ SubQ

FIGURE W

FIGURE X

FIGURE U

FIGURE V

FIGURE Y

5.4 INSERTION OF IMPLANT IN INTRO-DUCING AID (HORIZONTAL POSITION)1. Extract the implant and the introduc-

ing aid from the sterile packs, remove the safety cap, and position as depicted (FIGURE U).

2. Place the implant at the tip of the intro-ducing aid shaft (FIGURE V) and gently pull it towards the introducing aid handle, leaving the electrode inside the shaft. Use the index finger to keep the electrode in place (FIGURE W).

3. Place the implant house in the handle of the introducing aid. Make sure to insert the full length of the electrode, leaving the implant house as depicted (FIGURE X), resulting in the tip of the introducing aid shaft being extended approximately 1 mm from the distal end of the electrode.

4. Bend the introducing aid carefully to fit the curved shape of the subject’s skull (FIGURE Y).


UNEEG™ SubQ

5.5 ELECTRODE INSERTION IN SUBGALEAL SPACE (HORIZONTAL POSITION)

WARNING • Do not use the full length of the in-

troducing aid when implanting in the direction of the temple, as this might cause damage to nervus facialis ramus temporalis.

1. Insert the introducing aid in the subgaleal space from the top of the incision, and gently push it approximately 60 mm in the direction of the temple (FIGURE Z). It is recommended to place the electrode submuscularly.

2. Lift the implant house slightly upwards and release it from the introducing aid.

3. Withdraw the introducing aid carefully, leaving the electrode in situ (FIGURE AA).

FIGURE Z

FIGURE AA


UNEEG™ SubQ

FIGURE DD

5.7 CLOSURE (HORIZONTAL POSITION)1. Close the incision in one layer with non-

resorbable sutures (FIGURE DD).

Care should be taken that any contact be-tween the sewing needle and the implant house or the electrode is avoided.

5.6 IMPLANT INSERTION IN SUBCUTA-NEOUS POCKET (HORIZONTAL POSITION) 1. Insert the house in the subcutaneous

pocket (FIGURE BB), and insert the house in the subcutaneous pocket (FIGURE CC).

Note: Bending the electrode might induce rotation of the house over time, potentially displacing the electrode towards the temple. This should be considered when placing the electrode.

FIGURE BB

FIGURE CC


UNEEG™ SubQ

IMPORTANT: In case of suspicion that the implant is malfunctioning, it is recommended to consult UNEEG medical before starting an explantation.

6.1 SUBJECT PREPARATION1. Put the subject in a supine position.2. Inspect the skin above the implant for

any signs of infection or ischemia.

6.2 INFILTRATION ANALGESIA1. Cleanse the skin of the implantation site

thoroughly with chlorhexidine or similar, and perform the explantation using full aseptic technique.

2. Inject local analgesia (lidocaine with adrenaline or similar) at the implantation site.

6.3 REMOVAL OF THE IMPLANT1. Make a 25 mm incision at the site of the

scar from the implantation (FIGURE EE). 2. Liberate the implant by blunt dissection,

and remove it from the implantation tis-sue pocket (FIGURE FF + FIGURE GG).

3. Retract the electrode by gently pulling it (FIGURE HH). Care should be taken to remove the electrode in full length.

Scar tissue can be cut away depending on the surgeon’s decision.

6. EXPLANTATION PROCEDURE

FIGURE EE

FIGURE GG

FIGURE FF

FIGURE HH


UNEEG™ SubQ

FIGURE II

6.4 CLOSURE1. Stich up the incision directly with non-

resorbable sutures (FIGURE II).


UNEEG™ SubQ

7.1 LIFETIME OF IMPLANTThe implant has a lifetime of 15 months after implantation. Before this period expires, the implant must be explanted.

The implant does not require service or calibration during its lifetime.

7.2 DISPOSALThe implant and the introducing aid must be disposed of according to standardised hospital procedures for waste handling. Not normal household waste.

Malfunctioning implants must be returned to UNEEG™ medical.

7. MAINTENANCE


UNEEG™ SubQ

Intended PerformanceThe 24/7 EEG™ SubQ records EEG.

ModificationNo modification of the equipment is allowed.

RepairsThe device contains no replaceable or repairable parts.

Environmental ConditionsThe following are the allowed environmental conditions for the device and accessories:

8. TECHNICAL DESCRIPTION

Pressure: 70 kPa (3000 m above sea level) to 150 kPa (5 m below sea level)

Relative Humidity: 10 % to 95 %

Temperature (transport): -10 °C to +55 °C (max 2 weeks)

Temperature (storage): +5 °C to +30 °C

Temperature (use): 0 °C to +40 °C


UNEEG™ SubQ

Specifications & CharacteristicsThe device system consists of the following parts:

UNEEG™ SubQ (implant)

House 24x17x3.3 mm.Ceramic, titanium, silicone, tungsten, gold and ruby feed through overload.

Electrode variants 103 mm.Silicone.3 contact points.

Contact points Outer diameter: 1.1 mm.Length: 10 mm.Pt-Ir.

Introducing Aid

Handle 27.8x35x25.8 mm.Medical grade permanent antistatic acrylonitrile butadiene styrene (ABS).

Shaft variants Length: 97 mmOuter diameter: 2.11 mmInner diameter: 1.55 mm304 stainless steel tubing.


UNEEG™ SubQ

9. SYMBOLS AND MARKINGS

Manufacturer

Date of manufacture

Use-by date

Batch number

Catalogue number

Serial number

CE marking: Declaration that the product meets all the safety, health, and environmental protec-tion requirements for CE marking and can be sold throughout the EEA.

Not for general waste

Warning: Messages with this heading indicate serious ad-verse reactions, potential safety hazards and inadequate perfor-mance of device.

Consult instructions for use

Temperature limits

Humidity limits

Do not use if package is damaged

Do not re-sterilise

Do not re-use

Sterilised using ethylene oxide

Sterilised using irradiation

Open here

Open by hand

Explanation of symbols found on products and on packaging:

Markings found on implant:

Serial number (SN)

Model tag (x-ray readable)

1. Fill in the blank spaces of the medical implant ID card with a permanent pen.

2. Cut out the card with a pair of scissors.3. Hand over the card to the subject.4. Instruct the subject to always wear the

ID card, e.g. in the wallet.

10. MEDICAL IMPLANT ID CARD

Full name:

Date of implantation:

Position of implant:

Implant serial no.:

Implant model: H02-10

Nymøllevej 6 · 3540 Lynge · Denmark · [email protected] · +45 30 10 14 54

MEDICAL IMPLANT ID CARD

This person carries 24/7 EEG™ SubQ, a medical electroencephalography (EEG) recording device consisting of an implant and an external part. The implant is located under the skin at the side of the head. The external part is connected behind the ear to record EEG.

Warning. The following may result in severe patient injury or device malfunction. Explant the implant before:• MRI scan• Therapeutic ionising radiation at implant site • Therapeutic ultrasound at implant site• Electrical current induced at implant site (e.g. electro knife)

Nymøllevej 63540 LyngeDenmark

www.uneeg.com

E-mail: [email protected]: +45 30 10 14 54

03442019

2020/06Rev. IFU-10001-7

© 2020 UNEEG™ medical

UNEEG™ SUBQ

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