• CMF SURGERY

Inion's product range of biodegradable craniomaxillofacial implants includes surgical plates, screws, instruments and accessories for craniofacial, orthognathic and trauma surgery.

Within each product group, several different plates and screws are supplied for different surgical purposes.

• THE IDEAL IMPLANT FOR CMF SURGERY

The qualities for an ideal fixation system are adequate strength and rigidity, lack of adverse tissue reactions, lack of interference with bone healing, lack of intra-cranial migration, lack of visibility and palpability, and avoidance of an implant removal operation.

Surgeons appreciate good handling properties, such as plate malleability, good fit and easy screw pick-up, avoidance of tapping, and screws with good torsional strength.

• 1. Description
The INION Thermo water bath is a medical, electrical device intended for continuous operation. Its purpose is to provide a safe, simple and effective method of preparing heated water for use with INION products.

• 2. Indications for Use
The INION Thermo water bath, in conjunction with the Thermo Drape (Ref. No. ACC-9802), is intended to heat sterile liquid to approximately 55 C +/- 5 C and maintain a relative temperature for the thermo-forming of appropriate INION implants.

• 3. Instructions for Use
• Operation of the INION Thermo water bath requires connection to a 220 - 240 VAC 50 Hz, minimum 1 A outlet.
• The Thermo Drape (Ref. No. ACC-9802) must be placed over the unit before adding liquid to the tank.
• Fill the tank with sterile water. Full capacity of the tank is approximately 0.7 litres. INION recommends that a minimum of 0,4 litre should be maintained in the tank.
• After connection to the outlet, the green power switch must be in the "ON" position. The signal lamp and "ON/OFF" marking adjacent to the switch will indicate whether the power is on or off. When operating the switch, support the device from behind.
• The liquid in the tank will attain the preferred temperature, approximately 55 C +/- 5 C, 20 minutes after the power is switched on. The use of warm sterilised fluid will shorten the heating time.
• After use, return the green power indicator switch to the "OFF" position and disconnect the device from the electrical outlet. It is recommended that the unit is allowed to cool to room temperature before returning it to a safe storage area. Dispose of the fluid according to safe operating room procedures.

• 4. Prohibitions for Use
• Do not use with screws
• Do not use the INION Thermo water bath without the Thermo Drape
(Ref. No. ACC-9802) or with other manufacturers' drapes
• Do not use with other manufacturers' products or implants
• Do not drape the INION Thermo water bath when hot
• Do not use with non-sterile liquids
• Do not use with less than 0.4 litre of liquid
• Do not use with power supplies other than those recommended on
the device
• Do not use with sharp or pointed instruments
• Do not use on or near the patient
• Do not use on unstable stands or carts

• 5. Cleaning and Sterilisation
• The INION Thermo water bath is provided non-sterile. The Thermo Drape (Ref. No. ACC-9802) must be used at all times to ensure the sterility of the liquid poured into the draped tank.
• The INION Thermo water bath may be cleaned after use by using a damp cloth and warm water or diluted cleaning solution.
• The INION Thermo water bath cannot be sterilised.

• 6. Storage and Handling
• Transportation and storage under controlled conditions, temperature 15 - 30 C, relative humidity below 60%.
• The device must be properly cleaned immediately after use.
• It is recommended that the original packaging for the INION Thermo water bath should be used when transporting the device.

• 7. Service and Maintenance
• There are no parts in the INION Thermo water bath that requires servising.
• No maintenance is necessary. However, in case of malfunction, please
return the INION Thermo water bath to the manufacturer,
FINNSONIC OY, Parikankatu 8, 15170 Lahti, Finland. Do not attempt to
service.

• 8. Warnings
• Turn off immediately after use.
• Do not use the device without fluid in the tank.
• Do not remove the bottom plate. Return to FINNSONIC for service.
• Caution: Contains hot fluid (55 C)

• 9. Technical Data
• Tank volume: Max. 0.7 litres
• Heating power: 150 W
• Fuses: 2 x 1,0 AF, 5 x 20 mm
• Electric connection: 220 - 240 VAC 50 - 60 Hz
• Connection power: 150 W
• Main fuse: 1 x 10 A
• Supply cable: 3 x 0,75S

• Ideal Implant

The ideal implant for craniomaxillofacial (CMF) surgery
The ideal implant would be made of a biodegradable material, which

1. Can be fabricated and designed with appropriate initial strength to meet the biomechanical demands;
2. Degrades in a predictable manner and allows for safe progressive loading during the bone-healing process;
3. Causes no tissue response necessitating device removal;
and
4. Disappears completely.

Plates will degrade gradually as bone starts to bear loading

• 30 Years Of Excellent Results With Biodegradable Implants
Biodegradable polymers have been used in surgical applications for the past 30 years as suture materials and bone fixation devices. In the last two decades, the use of biodegradable materials has expanded to include a number of other fixation applications. Since the 1970s, the excellent biocompatibility of the polymers used by Inion Ltd. has been documented in hundreds of scientific articles.