Instructions for Use — OtoJig System

℞only

The latest versions of all instructions for use are available at:
https://otojig.com/IFU/.

Version of this document: v0.4, issued 2026-01-06, OtoJig GmbH. All rights reserved.

Description and Identification of Devices

The OtoJig procedure involves a number of medical devices which, when inter-connected or combined, are intended to achieve the following medical purpose:

The OtoJig system is intended to create a minimally invasive surgical tunnel in the temporal bone and to provide a covered access to the inner ear.

Healthcare Professionals can verify the suitability of the OtoJig devices by consulting this instructions for use. The selection of corresponding software and accessories is limited to the following lists of OtoJig devices and compatible 3rd-party devices.

OtoJig System

The OtoJig System includes the following OtoJig and third-party devices listed below. The mutual compatibility of the devices has been verified in accordance with the manufacturer's instructions, and all required activities have been performed in accordance with those instructions.

OtoJig Devices

Third-Party Devices

Materials, Supplied Condition, and Reusability

The table below lists the materials and substances from which the OtoJig devices are made, the supplied condition, and the reusability. All (hardware) devices are to be used in sterile condition.

Intended Purpose

ConCIerge is intended to plan minimally invasive access tunnels in the temporal bone.

The Mini-Stereotactic Frame (Including Optical Reference Marker) is intended to be attached to the skull behind the patient’s ear by using the Mounting Screw and the Anchor. It is intended to carry the Positioning Jig or the X-Ray Marker.

The Anchor is intended to serve as a fixation point attached to the skull behind the ear.

The Mounting Screw is an accessory for the medical device Mini-Stereotactic Frame. The Mounting Screw is intended to keep the Mini-Stereotactic Frame in position on the skull behind the patient’s ear.

The Jig Fastener is an accessory for the medical devices Positioning Jig and X-Ray Marker. The Jig Fastener is intended to fasten either the Positioning Jig or the X-Ray Marker onto defined mounting sockets.

The Tool Guide is intended to restrict movements of Round Window Opener or drill bits along a pre-planned access tunnel.

The Positioning Jig is intended to position a Tool Guide according to a pre-planned access tunnel relative to the position of the Mini-Stereotactic Frame.

The Round Window Opener is intended to open the round window membrane of the cochlea.

The Insertion Tube is intended to provide a covered canal in the temporal bone.

The X-Ray Marker, whilst mounted on the Mini-Stereotactic Frame, is intended to be locatable by a planning software in a computed tomography volume image.

Medical Indications, Contraindications & Patient Population

All OtoJig devices are intended for use with adult patients.

ConCIerge is indicated for:

• visualization of computed tomography volume images of the human temporal bone,

• planning of minimally invasive access tunnels in the temporal bone, and

• assisting surgeons in drilling the planned access tunnels.

ConCIerge is contraindicated for:

• Visualization of computed tomography volume images and planning of access tunnels is contraindicated for patients where either no computed tomography volume image could be acquired due to medical reasons or where the computed tomography volume image is of insufficient quality, including movement of the patient during acquisition, or other reasons which make it impossible for the surgeons to clearly identify the boundaries of the anatomical structures.

• Planning of access tunnels is contraindicated for patients where the planned access tunnel may intersect the segmentations of the facial nerve canal or the wall of the outer ear canal.

• The assistance in drilling of a pre-planned access tunnel is contraindicated for patients with cholesteatoma in the surgical area of the planned access tunnel.

The Mini-Stereotactic Frame is indicated for surgical procedures that benefit from the support of the Positioning Jig or the X-Ray Marker in a position attached to the patient’s skull behind the ear.

The Mini-Stereotactic Frame is contraindicated for:

• patients with bone disease in area of surgery,

• patients with infection in the surgical area,

• patients with suspected sensitivity or allergies to titanium alloy, and

• insufficient or inadequate hard tissue.

The Anchor is indicated for surgical procedures that benefit from a fixation point attached to the skull behind the ear.

The Anchor is contraindicated for:

• patients with bone disease in area of surgery,

• patients with infection in the surgical area,

• patients with suspected sensitivity or allergies against titanium alloy, and

• insufficient or inadequate hard tissue.

The Mounting Screw is an accessory for the Mini-Stereotactic Frame.

The Mounting Screw is contraindicated if the Mini-Stereotactic Frame is contraindicated.

The Jig Fastener is an accessory for the Positioning Jig and the X-Ray Marker.

The Jig Fastener is contraindicated if the Positioning Jig and the X-Ray Marker are contraindicated.

The Tool Guide is indicated for surgical procedures that benefit from restricting movement of the Round Window Opener or drill bits along a pre-planned access tunnel.

The Tool Guide is contraindicated for patients with suspected sensitivity or allergies against chromium stainless steels.

The Positioning Jig is indicated for surgical procedures which benefit from the positioning of a Tool Guide according to a pre-planned access tunnel in relative position to a Mini-Stereotactic Frame.

The Positioning Jig is contraindicated for patients with suspected sensitivity or allergies against Polypropylene (PP).

The Round Window Opener is indicated for surgical procedures that require opening of the round window membrane of the cochlea.

The Round Window Opener is contraindicated for patients with

• bone disease in area of surgery,

• infection in the surgical area, and

• suspected sensitivity or allergies against chromium stainless steels.

The Insertion Tube is indicated to form a covered canal in the temporal bone.

The Insertion Tube is contraindicated for patients with

• bone disease in area of surgery,

• infection in the surgical area, and

• suspected sensitivity or allergies against polyimide.

The X-Ray Marker is indicated for surgical procedures that benefit from a marker which is locatable in a computed tomography volume image.

The X-Ray Marker is contraindicated for patients:

• with suspected sensitivity or allergies against polyether ether ketone (PEEK), and

• where either no computed tomography volume image could be acquired due to medical reasons or where the computed tomography volume image is of insufficient quality, including movement of the patient during acquisition, or other reasons which make it impossible to clearly identify the embedded radio-dense metal balls.

Intended User and User Training

Intended user

• ConCIerge:

  • All trained medical professionals (physicians, nurses, technicians) and medical device advisors/experts can operate conCIerge.

  • Approving segmentations and planned access tunnels have to be performed by a trained ENT surgeon.

• Anchor, Mounting Screw, Mini-Stereotactic Frame, Positioning Jig, X-Ray-Marker, Jig Fastener, Tool Guide, Round Window Opener, Insertion Tube:

  • Intended to be used by trained ENT surgeons.

Training

Training is provided by OtoJig. It includes personal handling of representative devices on a temporal bone model under the supervision of a qualified trainer.

Warnings and Precautions

General safety information

Mini-Stereotactic Frame (incl. Optical Reference Marker)

X-Ray Marker

Positioning Jig

Round Window Opener

Insertion Tube

Residual Risks and Undesirable Side-Effects

The medical devices are used in the context of or as part of other surgically invasive procedures such as cochlear implantation, middle ear surgery, or similar surgeries. The risks associated with the OtoJig procedure inherit the primary risks of those (conventional) surgeries, which contain: excessive bleeding, blood clots, death, delayed wound healing, infections, wound dehiscence, breathing difficulties due to infection, inflammation, diffuse swelling, tissue necrosis, necrosis, hematoma, leakage of cerebrospinal fluid, damage to the facial nerve, pain, scarring at the wound site, exanthema, skin lesions, skin irritation, difficulty swallowing, and complications associated with anesthesia. In addition, meningitis is a rare postoperative complication with cochlear implantation, but can be potentially serious. As with all skin incisions, the potentially additional incisions or puncturing of the skin can often lead to local wound healing disorders, infection, inflammation, or itching. The occurrence probability of these risks is influenced by multiple factors, such as surgical technique, skin incisions and the duration of the surgery.

The device-specific residual risks are:

Residual risks are described according to the following probabilities per use:

• Very frequent: ≥ 1 of 10 (10 %)

• Frequent: ≥ 1 of 100 (1 %) to < 1 of 10 (10 %)

• Occasional: ≥ 1 of 1,000 (0.1 %) to < 1 of 100 (1 %)

• Rare: ≥ 1 of 10,000 (0.01 %) to < 1 of 1,000 (0.1 %)

• Improbable: < 1 of 10,000 (0.01 %)

Expected Clinical Benefits

The use of the OtoJig procedure offers several advantages, including reduced surgical drilling time and less healthy bone volume removal compared to traditional mastoidectomy procedures:

• Minimally invasive: The OtoJig procedure allows for a state of the art minimally invasive access to the middle and inner ear.

• Round window approach: The Round Window Opener allows inner ear access through the round window membrane.

• Shorter drilling time: The OtoJig procedure allows for a reduced drilling time compared to conventional mastoidectomy and posterior tympanotomy.

• Visualization & optimal path planning: ConCIerge helps surgeons to find and plan their preferred access path and to get a better understanding of the patient's individual anatomy in comparison to standard of care DICOM viewers.

• Insertion trajectory: ConCIerge allows to visualize and control the (planned) in-plane angle and the off-plane angle towards the cochlea.

• Insertion of CI: MED-EL FLEX SL electrodes can be advanced through the Insertion Tube into the inner ear through the access created by the OtoJig procedure.

General Processing Instructions

Devices: Anchor, Mounting Screw, Jig Fastener, Tool Guide and Round Window Opener

Processing instructions according to ISO 17664-1.

The instructions provided in these instructions for use have been validated by the manufacturer of the non sterile single-use medical devices as being capable of preparing a medical device for use. 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. This requires verification and/or validation and routine monitoring of the process.

1 Processing

1.1 Automated Cleaning, Disinfection and Drying

Perform automated cleaning, disinfection and drying:

1. Prewash with cold water for at least 4 minutes – drain

2. Wash with a detergent (Neodisher® MediClean forte (1%)) at +55 °C for at least 5 minutes – drain

3. Rinse with cold water³ for at least 1 minute – drain

4. Disinfect with hot water³ at +93 °C for at least 5 minutes – drain

5. Dry with hot air at +100 °C for at least 20 minutes

Validation was performed with a washer/disinfector Belimed WD 290 IQ.

1.2 Inspection

Visually inspect the device for damages, remaining contaminations, and moisture. If there are contaminations or moisture, repeat cleaning/disinfection process and inspection.

1.3 Packaging

1. Place the device in a carrier (e.g. a surgical instrument tray). Do not stack devices.

2. Double wrap in accordance with ISO 11607-1.

1.4 Sterilization

Use a fractionated vacuum sterilization method in accordance with ISO 17665 and national recommendations. This method has been validated to achieve the desired sterility assurance level (SAL) of 10^-6.

Phase 1 – Conditioning

A vacuum is generated up to four times. Steam is then injected to warm the device.

Phase 2 – Sterilization

The validated parameters for the fractionated pre-vacuum method are:

• Temperature: +134 °C

• Exposure time: at least 5 minutes

Phase 3 – Evacuation

The steam is released.

Phase 4 – Drying

Drying takes place under application of a vacuum.

After sterilization, cool the device uniformly at room temperature.

Sterilization validation was performed with an autoclave Hospithera CISA 6464LS Steam Sterilizer and MED-EL Surgical Instrument Tray (REF 41452) double wrapped in Halyard Sequential Sterilization Wrap H500. Drying was done over a period of at least 30 minutes.

1.5 Storage After Sterilization

Store the wrapped and sterilized device in accordance with the specifications provided by the manufacturer of the sterilization wrapping material.

Device: Positioning Jig

There are two methods for processing the Positioning Jig: disinfection or sterilization. Both are described below:

1 Processing - Sterilization approach

The processing consists of the following steps:

• manual cleaning ³,

• inspection,

• packaging, and

• sterilization.

The device is a patient-matched device to be manufactured and processed during surgery at the point of use. Due to time constraints associated with the anesthesia duration, an automated cleaning process cannot be used, as it would extend the anesthesia time to an unacceptable length.

The instructions provided in these instructions for use have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use. 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. This requires verification and/or validation and routine monitoring of the process.

1.1 Manual Cleaning and Draining

Perform manual cleaning and drying:

1. Wash with a cleaning solution (gigasept® pearls (2%)) at ambient temperature for at least 10 minutes. Ensure that all surfaces are covered by the cleaning solution. Drain cleaning solution from the device.

2. Rinse with cold water ⁴ for at least 1 minute – drain

1.2 Inspection

Visually inspect the device for damages and remaining contamination. If there is remaining contamination, repeat cleaning process and inspection.

1.3 Packaging

1. Place the device in a carrier (e.g. a surgical instrument tray). Do not stack devices.

2. Double wrap in accordance with ISO 11607-1.

3. Label the packaging with a patient identifier to prevent mix-ups.

1.4 Sterilization

Use a fractionated vacuum sterilization method in accordance with ISO 17665 and national recommendations. This method has been validated to achieve the desired sterility assurance level (SAL) of 10${}^{-6}$$^{-6}$.

Phase 1 – Conditioning

A vacuum is generated up to four times. Steam is then injected to warm the device.

Phase 2 – Sterilization

The validated parameters for the fractionated pre-vacuum method are:

• Temperature: +134 °C

• Exposure time: at least 5 minutes

Phase 3 – Evacuation

The steam is released.

Phase 4 – Drying

Drying takes place under application of a vacuum.

After sterilization, cool the device uniformly at room temperature.

Sterilization validation was performed with an autoclave Hospithera CISA 6464LS Steam Sterilizer and MED-EL Surgical Instrument Tray (REF 41452) double wrapped in Halyard Sequential Sterilization Wrap H500.

2 Processing - disinfection approach

The processing consists of the following steps:

• manual cleaning,

• disinfection,

• inspection, and

• packaging.

The device is a patient-matched device to be manufactured and processed during surgery at the point of use. Due to time constraints associated with the anesthesia duration, an automated cleaning process cannot be used, as it would extend the anesthesia time to an unacceptable length.

The instructions provided in these instructions for use have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use. 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. This requires verification and/or validation and routine monitoring of the process.

2.1 Manual Cleaning and Disinfection

Perform manual cleaning, disinfection, and drying:

1. Prepare a cleaning/disinfection solution of Gigasept® Pearls (2%) in accordance with the manufacturer's instructions.

2. Place the device in the cleaning/disinfection solution at ambient temperature for at least 15 minutes. Ensure that all surfaces are covered by the cleaning/disinfection solution. OtoJig recommends the use of the OtoJig disinfection bath with the included insert.

3. Use sterile instruments/gloves to remove the device from the cleaning/disinfection solution. Drain the cleaning/disinfection solution from the device.

4. Rinse with sterile water for at least 1 minute – drain.

2.2 Inspection

Visually inspect the device for damage and remaining contamination. If there is any remaining contamination, repeat steps 2.1 and 2.2.

Caution: Discard the device if damaged.

2.3 Packaging

1. Place the device in a self-adhesive sterile bag.

2. Seal the sterile bag with the adhesive sealer. Make sure that no air leaves the bag if it is pressed. Replace leaking bags.

3. Label the carrier with a patient identifier to prevent mix-ups.

Devices: Mini-Stereotactic Frame and X-Ray Marker

1 Reprocessing

Reprocessing instructions according to ISO 17664-1.

The instructions provided in these instructions for use have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use. It remains the responsibility of the processor to ensure that the reprocessing, as actually performed, using equipment, materials, and personnel in the reprocessing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the process.

1.1 Initial Treatment at the Point of Use

1. Prepare a bath with demineralized water.

2. Immediately after use, immerse the device in the bath to prevent drying.

The device must be reprocessed as soon as reasonably practical following use and not later than 24 hours after use.

Store and transport the device to the reprocessing site in a moist environment. Use a closed container in order to avoid contamination of the environment.

1.2 Preparation Before Automated Cleaning

Every component must be disconnected prior to cleaning, disinfection and sterilization.

Manual Pre-Cleaning

1. Prepare a bath with demineralized water.

2. Carefully and gently brush the device in the bath of demineralized water for at least 30 seconds until all visible soil is removed.

• Pay attention to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas.

• Do not use metal brushes or scouring pads during manual pre-cleaning. These materials damage the surface and finish of the device. Use soft-bristled nylon brushes.

• Keep the device below the surface of the cleaning solution during manual scrubbing to prevent the generation of aerosols and splashing which may spread contaminants.

1.3 Automated Cleaning, Disinfection and Drying

Automated cleaning must be performed immediately after manual pre-cleaning.

1. Prewash with cold water for at least 4 minutes – drain

2. Wash with a detergent (Neodisher® MediClean forte (1%)) at +55 °C for at least 5 minutes – drain

3. Rinse with cold water ³ for at least 1 minute – drain

4. Disinfect with hot water ³ at +93 °C for at least 5 minutes – drain

5. Dry with hot air at +100 °C for at least 20 minutes

Validation was performed with a washer/disinfector Belimed WD 290 IQ.

1.4 Inspection

Caution: Discard the device if damaged, worn, corroded or if the labeling is illegible.

Visually inspect the device for remaining soil in a well-lit area; no visible soil or moisture must be left on the device. If there is remaining debris, repeat the cleaning process and re-examine.

1.5 Packaging

1. Place the device in a suitable carrier. Do not stack devices.

2. Double wrap in accordance with ISO 11607-1.

1.6 Sterilization

Use a fractionated vacuum sterilization method in accordance with ISO 17665 and national recommendations. This method has been validated to achieve the desired sterility assurance level (SAL) of 10${}^{-6}$$^{-6}$.

Phase 1 – Conditioning

A vacuum is generated up to four times. Steam is then injected to warm the device.

Phase 2 – Sterilization

The validated parameters for the fractionated pre-vacuum method are:

• Temperature: +134 °C

• Exposure time: at least 5 minutes

Phase 3 – Evacuation

The steam is released.

Phase 4 – Drying

Drying takes place under renewed application of a vacuum over a period of at least 30 minutes.

After sterilization, cool the device uniformly at room temperature.

Sterilization validation was performed with an autoclave Hospithera CISA 6464LS Steam Sterilizer and MED-EL Surgical Instrument Tray (MED-EL REF 41452) double wrapped in Halyard Sequential Sterilization Wrap H500.

1.7 Storage After Sterilization

Store the wrapped and sterilized device in accordance with the specifications provided by the manufacturer of the sterilization wrapping material.

Storage and transportation

Store all devices in a dry and clean environment, protected from direct sunlight, pests and extremes of temperature and humidity.

Store sterilized devices according to the (re-)processing instructions.

Store sterile delivered devices as indicated on the label of the sterile barrier system / packaging.

Use products in the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on the label.

Only use the original packaging for transport as damage may occur otherwise. If the original packaging materials are no longer available, please contact OtoJig.

Lifetime of the Devices

The single-use (excl. Positioning Jig) devices are intended for short term use; their lifetime is limited to the duration of the procedure. The shelf life is limited to five years.

Positioning Jig: The lifetime is limited to the duration of the procedure. The shelf life is limited to 24 hours.

The reusable devices are intended for short term use; their lifetime is limited to 50 reprocessing cycles. The shelf life is limited to five years.

Disposal of the Devices

Dispose of in accordance with federal, state, and local regulations.

Dispose the devices Round Window Opener and Mini-Stereotactic Frame in a suitable container for sharp devices.

Please return used Positioning Jigs after cleaning. OtoJig may provide a discount for the next order.

OtoJig Surgical Procedure:

This procedure can be used for

• creating a minimally invasive surgical tunnel in the temporal bone, and

• optionally to provide a covered access to the inner ear, e.g. for cochlear implantation (CI). These optional steps are marked by 🌀.

Optional screening: Pre-planning in conCIerge

If a pre-operative CT/CBCT volume scan is available for a potential patient, it is recommended to use conCIerge for screening to alleviate the intra-operative risk that no (safe) access tunnel can be planned for a given patient due to anatomic constraints.

• From the main screen of the app, choose "Screening".

• Import the DICOM data of the scan into conCIerge.

• Attempt to plan a virtual access tunnel.

• Approve, if applicable, and conclude whether the patient would be suitable for the OtoJig procedure.

Create new case in conCIerge

• Create a new case for the patient in the planning app conClerge, identifying the patient by name, birthday, sex, and hospital patient-ID, if applicable.

• Select the side for the surgery (left/right)

• Select if an inner ear access shall be planned. 🌀

Check availability of devices

The following devices have to be available for creating a minimally invasive surgical tunnel in the temporal bone and to provide a covered access to the inner ear:

• 1x charged iPad device with the conCIerge app installed (see eIFU of conCIerge)

• 1x Mini Stereotactic Frame (including 1x Optical Reference Marker)

• 2x Bone Screw + 2x Emergency Bone Screw

• 1x Screw Driver incl. blade

• 2x Anchor

• 1x Mounting Screw

• 3x Jig Fastener (Shell and Pin)

• 1x Blank Jig, i.e. a not yet individualized Positioning Jig

• 1x X-Ray Marker

• 1x Tool Guide

• 1x Round Window Opener 🌀

• 1x Insertion Tube 🌀

• 1x Pre-drill bit

• 1x OtoDrill 1

• 1x OtoDrill 2

• 1x OtoDrill 3 🌀

• 1x Drill motor/hand-piece

  Recommendation
  

  A drill motor/hand-piece with a maximum speed of 3,000 rpm for the OtoDrills and the Pre-drill bit, such as the DePuy Synthes UNIUM battery drill (05.001.601) unit with a three jaw chuck (05.001.252 or 01.001.523).

• 1x Facial nerve monitoring system

• Availability of CT/CBCT device

  Recommendation
  

  It is recommended to test each CT/CBCT scanning device and/or each intermediate DICOM exporting software application prior to use by scanning an X-Ray Marker (without patient) and importing the DICOM into conCIerge.

• 1x Surgical pen for skin marking

• 1x USB (Type-C) drive, recommended USB 3.0 "super speed" or faster and at least 256 GB storage capacity, ExFAT formatted

The following devices have to be available for performing a cochlear implantation:

• 1x MED-EL FLEX SL cochlear implant electrode 🌀

• 1x conventional ⌀0.8 mm surgical bur — to create a groove for holding the electrode lead 🌀

Prepare the point of care production machine - Otomat

Prepare the point of care production machine (Otomat) according to the instructions for use of the Otomat.

Facial nerve monitoring

Setup facial nerve monitoring according to its IFU.

Prepare patient

• Place the patient using a head rest suitable for intraoperative CBCT scan, if available.

• Wash, disinfect, and shave surgical area behind the ear large enough for the MSF and the Optical Reference Marker.

• Select and mark the position for the MSF, including the positions for the spikes. In particular, mark the position for first Bone Screw (and Anchor) in an area with sufficient skull thickness (> 4 mm). One spike of the Mini-Stereotactic Frame shall be located on the mastoid process, close to the mastoid tip. The middle spike shall be posterior to the ear. The (virtual) connection line between the two outermost spikes is often perpendicular to the orbito-meatal-line.

  Recommendation
  

  It is essential to ensure that the Mini-Stereotactic Frame is positioned correctly on the mastoid tip. A skin incision that provides a suitable view for assessing the contact of the Mini-Stereotactic Frame spikes is recommended.

• Select and mark a position for the Optical Reference Marker, by marking the position to place the second Bone Screw in an area with sufficient skull thickness (> 4 mm). The distance between the optical marking (pattern) on the MSF and the Optical Reference Marker should not be further apart than ~5 cm.

• Optionally, mark a position for the CI implant. 🌀

  Recommendation
  

  To facilitate a smooth procedure, it is recommended to place the MSF so that the implant bed can be created in the bone later, if necessary, while the MSF remains in place.

Skin incision and fixation of the first Anchor with a Bone Screw

• Perform the skin incision and scrape the periosteum at the marked spot for the first Bone Screw, which is intended for the MSF. The larger skin incision should be done at a later step to minimize infection risks during CT/CBCT scanning with the MSF attached.

• Pre-drill (with the ⌀1.50 mm Pre-drill bit) the hole for the Bone Screw at the marked position using the MSF temporarily as a guidance. Set the MSF aside for further use.

  Caution
  

  Ensure sufficient skull thickness (> 4 mm) for the pre-drilling. If in doubt, drill in small intervals and check the bottom of the hole for bone. If there is sufficient bone, proceed with drilling.

• The pre-drill hole must be thoroughly cleaned before the Anchor is fixed to the skull. Take care to ensure that the pre-drill hole is free from any further contaminants.

• Fixate the first Anchor to the skull at the pre-drilled hole using the screw driver and a Bone Screw. The Anchor must be firmly attached to the bone without play.

  Recommendation
  

  Tighten the screw with a torque of 30 - 35 Ncm is recommended.

  • If the Bone Screw cannot be fixed sufficiently, an attempt with the Emergency Bone Screw (with a larger diameter of ⌀2.3 mm) can be made.

  • Alternatively, a new hole can be pre-drilled in the vicinity.

Fixation of the Mini-Stereotactic Frame to the first Anchor

• Perform skin incisions and scrape periosteum at the marked positions of the spikes of the MSF.

• Fixate the MSF with the Mounting Screw to the first Anchor. Tightening the screw with a torque of 30 Ncm is required.

  Warning
  

  Tightening the Mounting Screw with an insufficient torque may lead to loosening of the MSF.

• Make sure the spikes are in direct contact to the bone of the skull without a layer of periosteum in between.

• After securing the Anchor and the Mini-Stereotactic Frame with the Mounting Screw, visually check that they are not in contact with one another. If there is contact between the Anchor and the Mini-Stereotactic Frame, the Mini-Stereotactic Frame needs to be detached and repositioned.

  Recommendation
  

  It is essential to ensure that the Mini-Stereotactic Frame is positioned correctly on the mastoid process. A skin incision that provides a suitable view for assessing the contact of the Mini-Stereotactic Frame spikes is recommended.

Fixation of the second Anchor and Optical Reference Marker

• Make or extend the skin incisions for the fixation of the second Anchor, if necessary. Scrape the periosteum at the marked spot for the Bone Screw.

• Pre-drill (with the ⌀1.50 mm Pre-drill bit) at the marked position.

  Caution
  

  Ensure sufficient skull thickness (> 4 mm) for the pre-drilling. If in doubt, drill in small intervals and check the bottom of the hole for bone. If there is sufficient bone, proceed with drilling.

• The pre-drill hole must be thoroughly cleaned before the Anchor is fixed to the skull. Take care to ensure that the pre-drill hole is free from any further contaminants.

• Screw a second Anchor to the skull at the pre-drilled hole, using a compatible Bone Screw. The Anchor must be firmly attached to the bone without play.

  Recommendation
  

  Tighten the screw with a torque of 30-35 Ncm is recommended.

  • If the Bone Screw cannot be fixed sufficiently strong, an attempt with the Emergency Bone Screw (with a larger diameter of ⌀2.3 mm) can be made.

  • Alternatively, a new hole can be pre-drilled in the vicinity.

• Screw the Optical Reference Marker firmly onto this second Anchor by a manual clock-wise rotation.

  Caution
  

  From this point on, avoid load to the Optical Reference Marker, as its position is used to check that the MSF remained at its initial position, on which the planning is based on.

Mount X-Ray Marker

• Mount an X-Ray Marker onto the MSF and fixate it with three Jig Fasteners.

  • Place the X-Ray Marker on the mounting sockets of the Mini-Stereotactic Frame using gentle pressure so that there is no gap between the X-Ray Marker and the Mini-Stereotactic Frame.

  • Once the X-Ray Marker is correctly mounted on the Mini-Stereotactic Frame, secure it in place using three Jig Fasteners. To do this,

    • first insert the Jig Fastener shells into the fixation holes of the X-Ray Marker,

    • make sure that the shells are aligned with the bevel of the X-Ray Marker,

    • using minimal force, push the three Jig Fastener pins into the Jig Fastener shells until the Jig Fastener pins engage. When successfully inserted, a slight "click" will be heard and felt.

• After assembly, check that the three Jig Fasteners are firmly secured. This can be done by

  • visually checking that the shells are still aligned with the bevel of the X-Ray Marker and

  • manually checking that the Jig Fasteners are firmly seated in the X-Ray Marker.

• A non-sterile dressed person shall take a picture of the MSF and the Optical Reference Marker according to the instructions in the conCIerge app.

  Note
  

  Make sure the iPad (back) camera lenses are free of dirt. Clean dirty camera lenses.

• Scan the UDI of the X-Ray Marker using the conCIerge.

CT/CBCT scan

• Perform a CT/CBCT volume scan that fully includes the temporal bone area and the X-Ray Marker. For the CT scan, use the highest quality setting (bone protocol, if available) for a multi-planar reconstruction. The reconstructed volume has to be a regular grid with 0.3 × 0.3 × 0.3 mm per voxel, or better. Avoid tilting the gantry (offered by some CT devices). Make sure to avoid movement artifacts.

  Recommendation
  

  A CBCT scan in bone protocol is recommended over a CT scan, due to the typically lower radiation dose. Avoid radiation exposure to the eyeballs/lenses. Consider performing a scout scan to adjust the volume of interest (field of view) to avoid repeated radiation exposure.

  Caution
  

  No metal clips or similar shall be attached in close proximity to the situs during the CT scan.

  Recommendation
  

  To avoid any contaminations during the CT/CBCT scan, cover the whole Mini-Stereotactic Frame including the X-Ray Marker according to standard of care. Avoid load on the Optical Reference Marker.

• Export the reconstructed volume in DICOM format, e.g. to an USB drive.

Import DICOM into conCIerge

Please consult the eIFU of conCIerge in latest version at https://otojig.com/IFU in order to:

• Import the DICOM scan into conCIerge.

An automated check for suitability of the scan is performed. If the scan is found not to be suitable, a new CT/CBCT scan can be performed.

Remove X-Ray Marker

• Remove the Jig Fastener and the X-Ray Marker and put them aside for further use.

  Recommendation
  

  The best way to remove a Jig Fastener pin from the shell is with a simultaneous twisting and pulling motion.

Path planning

Please consult the eIFU of conCIerge in latest version at https://otojig.com/IFU and

• follow the onscreen instructions in conCIerge to plan and approve a virtual access tunnel.

Individualization of Positioning Jig

• Send the planned access tunnel to the Otomatic app for production of a patient individualized Positioning Jig.

  • Operate the Otomat and clean the individualized Positioning Jig according to the IFU of the Otomat.

  • Sterilize the Positioning Jig in accordance with the sterilization instructions.

Mount Positioning Jig

• Mark (e.g. with a surgical pen) the position of the planned access tunnel on the skin, using the through hole of the Positioning Jig.

  Warning
  

  Make sure the position of the path and its direction as seen through the attached Positioning Jig is approximately as expected for a path that is planned in the mastoid part of the temporal bone.

   

• Remove the Positioning Jig and put it aside for further use.

• Make a skin incision at the marked position and spread the wound with a small spreader. Ensure that the spreader fits under the Positioning Jig without pressing against the Mini-Stereotactic Frame.

• Insert the Tool Guide into the created hole of the Positioning Jig and press it firmly in until it reaches the stop of the stepped hole.

  Caution
  

  First press the Tool Guide in, then attach the Positioning Jig to avoid forces to the Mini-Stereotactic frame.

• Mount the individualized Positioning Jig, including the inserted Tool Guide, onto the MSF and fixate it with the three Jig Fasteners.

• Visually check that the Tool Guide does not come into contact with the skull bone when mounting it on the Mini-Stereotactic Frame. If contact cannot be avoided due to the planned trajectory, the corresponding area of the skull must be recessed slightly manually, e.g. using a bur.

  Caution
  

  The contact surfaces of the Positioning Jig with the MSF must be clean and free of debris to ensure accurate fit.

• A non-sterile dressed person shall take a picture of the MSF and the Optical Reference Marker according to the instructions in the conCIerge app. The software checks the relative position between MSF and Optical Reference Marker.

  Warning
  

  In case the bone fixation of the MSF has loosened, the surgery must not be continued.

• To assure the correct Positioning Jig is used, a non-sterile dressed person shall scan the QR-code of the Positioning Jig, according to the instructions in the conCIerge app.

Drilling — access tunnel

OtoDrill 1

• Insert the OtoDrill 1 carefully into the Tool Guide. Make sure that the OtoDrill 1 does not tilt.

  Recommendation
  

  Once the OtoDrill is fully inserted into the Tool Guide, it is recommended to move the OtoDrill up and down slightly without rotating it in the drilling axis (with the Unium Motor off) to get a better sense of its position in relation to the Tool Guide and the patient.

  

• When the OtoDrill 1 reaches the hard bone surface, use a high rotational speed but little force. Avoid non-axial (sidewards) forces.

Continue drilling through the bone in ~2-3 second intervals. Retract the OtoDrill 1 from the drilled canal and apply cooling water into the canal between the intervals.

• When the depth stop of the OtoDrill 1 reaches the Tool Guide surface, immediately retract the drill bit.

• Flood the drilled canal with water.

OtoDrill 2

• A non-sterile dressed person shall take a picture of the MSF and the Optical Reference Marker according to the instructions in the conCIerge app. The software checks the relative position between MSF and Optical Reference Marker.
  

• Insert the OtoDrill 2 carefully into the Tool Guide. Make sure that the OtoDrill 2 does not tilt.

  Recommendation
  

  Once the OtoDrill is fully inserted into the Tool Guide, it is recommended to move the OtoDrill up and down slightly without rotating it in the drilling axis (with the Unium Motor off) to get a better sense of its position in relation to the Tool Guide and the patient.

• Drill through the bone in intervals of approximately 2-3 seconds and retract the OtoDrill 2 from the drilled canal and apply cooling water into the canal between the intervals.

• When the depth stop of the OtoDrill 2 reaches the Tool Guide surface, immediately retract the drill bit.

• Flood the drilled canal with water.

• Access to the middle ear cavity (or any other planned and reachable target in the temporal bone) is now established. Clean the drilled canal and perform any desired surgical/medical steps that are now made possible with the minimally invasive access tunnel. For inner ear access, follow the steps marked by 🌀 or else continue with the Removal of OtoJig devices.

Bony overhang removal - OtoDrill 3 🌀

If, in addition to the middle ear access, inner ear access is desired, continue as follows:

• Insert the OtoDrill 3 carefully into the Tool Guide.

• Use the OtoDrill 3 to remove the bony overhang until the depth stop of the OtoDrill 3 reaches the Tool Guide surface.

Implant bed and groove for CI 🌀

• For CI, remove the Positioning Jig and create a small groove in the skull at the entry of the drilled tunnel for cochlea implant electrode lead fixation. The groove shall point towards the direction of the intended cochlea implant bed and will serve to fixate the electrode lead. Use a conventional ⌀ 0.8 mm surgical bur to create the groove.

• Create the implant bed and space to store excess electrode lead.

• Clean the surgical site from bone dust and flush the drilled tunnel and the middle ear cavity with sterile water and clean it with a suction device (use a suction tube ⌀ ≤ 1.5 mm to reach the middle ear). Repeat this cleaning 2-3 times to avoid bone dust entering the inner ear in the next step of the procedure.

  Caution
  

  Avoid damaging the round window membrane with the suction tube.

Round window opening 🌀

• For the opening of the round window membrane, mount and fixate the Positioning Jig (with the Tool Guide still inserted) onto the Mini-Stereotactic Frame.

• Open the round window membrane by advancing the Round Window Opener through the Tool Guide and rotating it slightly until it reaches the depth stop.

   

  Caution
  

  In the case of local anesthesia: pay attention to possible movements of the patient's head when using the Round Window Opener. Movements of the patient's head near the tip of the Round Window Opener can lead to injuries.

• The Positioning Jig can be removed and an endoscopic inspection of the round window opening can be performed. If necessary, re-attach the Positioning Jig (with the Tool Guide still inserted) and advance the Round Window Opener again. When the depth stop is reached, you can perform a slight rotation movement. Remove the Round Window Opener.

Removal of OtoJig devices

• Remove the OtoJig devices from the patient by:

  • Removing the Jig Fastener and unmount the Positioning Jig

  • Remove the Optical Reference Marker manually by a counter-clockwise rotation.

  • Unscrew the Mounting Screw, using a compatible screw driver.

  • Remove the MSF.

  • Unscrew the two bone screws using a compatible screw driver and remove the two Anchor(s).

Covering the canal using the Insertion Tube 🌀

• For covering a canal in the temporal bone, insert the Insertion Tube into the drilled canal until the target is reached. The Insertion Tube has a length of 31 mm and its inserted depth can be estimated by comparing the remaining non-inserted length with the planning in software conCIerge.

• For cochlear implantation:

  • Consult the instructions for use of the cochlear implant.

  • Orient the slit of the Insertion Tube towards the created bone groove and place the cochlear implant into the desired position.

  • Advance the electrode through the Insertion Tube into the cochlea. Lubricants can be used to reduce friction between the electrode and the Insertion Tube.

  • Fixate the electrode lead into the groove.

  • Carefully remove the slitted Insertion Tube with forceps. Make sure that the slit of the Insertion Tube slides past the electrode and that the electrode is not pulled by the Insertion Tube.

  • Complete the surgery as in for conventional CI surgery.

  Note
  

  If preferred or deemed necessary, an optional tympanic flap can be performed to open a view towards the middle ear and allow the micro manipulation with manual instruments.

   

  The Insertion Tube can also be used in a conventional surgical setting outside of this minimally invasive OtoJig surgical procedure.

Glossary of symbols

Symbol	Title	Description	Reference
	Manufacturer	Indicates the medical device manufacturer	ISO 15223-1
	Date of manufacture	Indicates the date when the medical device was manufactured	ISO 15223-1
	Use-by date	Indicates the date after which the medical device is not to be used	ISO 15223-1
	Batch code	Indicates the manufacturer’s batch code so that the batch or lot can be identified	ISO 15223-1
	Catalogue number	Indicates the manufacturer’s catalogue number so that the medical device can be identified	ISO 15223-1
	Country of manufacture	To identify the country of manufacture of products	ISO 15223-1
	Sterilized using irradiation	Indicates a medical device that has been sterilized using irradiation	ISO 15223-1
	Do not use if package is damaged and consult instructions for use	Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information	ISO 15223-1
	Double sterile barrier system	Indicates two sterile barrier systems	ISO 15223-1
	Single sterile barrier system with protective packaging outside	Indicates a single sterile barrier system with protective packaging outside	ISO 15223-1
	Keep away from sunlight	Indicates a medical device that needs protection from light sources	ISO 15223-1
	Keep dry	Indicates a medical device that needs to be protected from moisture	ISO 15223-1
	Do not re-use	Indicates a medical device that is intended for one single use only	ISO 15223-1
	Consult instructions for use or consult electronic instructions for use	Indicates the need for the user to consult the instructions for use	ISO 15223-1
	Caution	Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences	ISO 15223-1
	Medical device	Indicates the item is a medical device	ISO 15223-1
	Unique device identifier	Indicates a carrier that contains unique device identifier information	ISO 15223-1
	CE marking	‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in Regulation (EU) 2017/745 and other applicable Union harmonization legislation providing for its affixing	Regulation (EU) 2017/745
℞only	Prescription use only	Caution: Federal law restricts this device to sale by or on the order of a physician	21 CFR 801.109 (FDA)
	Health Industry Bar Code	The HIBC emblem is a sign for optical marking linear and 2-dimensional bar codes for indicating that the code contains the standard HIBC structure.	HIBC suggestion
🌀	Steps necessary for inner ear access.	If additionally to a minimally invasive access tunnel in the temporal bone, an access to the cochlear is desired, these steps and devices are required.	Custom. Used in this IFU.

Contact & legal

Reporting of serious incidents

Any serious incident that has occurred in relation to a device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

• the death of a patient, user, or other person,

• the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, or

• a serious public health threat.

Use the following contact for reporting of serious incidents: reporting@otojig.com or call +49 511 53859999

Contact

Address:

xxxxxxxxxx
OtoJig GmbH
Feodor-Lynen-Straße 35
30625 Hannover
Germany

https://otojig.com

Email: hello@otojig.com

The pictures provided in this material are for illustration purposes only and may not represent an actual device specification.

The trademarks used herein are trademarks of OtoJig GmbH, KLS Martin SE & Co. KG, Synthes GmbH, and MED-EL Elektromedizinische Geräte GmbH, respectively.