SUGITA ANEURYSM CLIPS

1. Specifications

Sugita Aneurysm Clips series offer the permanent type and temporary type. “Sugita Aneurysm Clip” herein referred to as “clip”. This clip is made of cobalt-chromium-nickelmolybdenum-iron alloy (ISO5832-7/ASTM F1058 G2). ASTM: American Society for Testing and Materials ISO: International Organization for Standardization This clip is designed for single-use only, is exclusively indicated only for use with the Sugita Aneurysm Clips Applying Forceps (hereinafter this is called "clip applier"), and requires cleaning and sterilization prior to use. Reuse may cause breakage of clips and may cause injury or infection. In order to ensure the traceability, a lot number is shown on each clip. The closing force of each clip is measured during the final quality assurance stage with a computerized electronic scale at a measuring point located 1/3 L from －2－

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the distal end of the blade length (L) of the clip [Figure 1] while its blades are opened at a 1.0 mm width. The result of this measurement is shown in newtons and grams on the package label. The product information including name and size are as indicated on the clip’s package label. Measured point

1.0

force

1/3L force L

[Figure 1]

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2. Types

Temporary type [Blade tip- Yellow]

Permanent type Standard Type

Standard Type

Mini Type

Mini Type

Large Type Long Type

Fenestrated Large Type For specific dimensions and shapes, please see this clip’s catalog.

3. Spring Type : Integral Coil 4. Action Mechanism : Alligator Action 5. Surface Finish - Clip Body - Material Treatment

: Satin : Electrolytic Polish

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6. Blade Cross-sectional Shape: Rolled 7. Indication for Use

The permanent type is indicated for the permanent occlusion of the neck of cerebral aneurysms. The temporary type is indicated for the temporary occlusion of the neck of cerebral aneurysms.

For the US market

The permanent type is indicated for the permanent occlusion of the neck of cerebral aneurysms and peripheral blood vessels. The temporary type is indicated for the temporary occlusion of the neck of cerebral aneurysms and peripheral blood vessels.

8. Directions for Use

This clip is packaged non-sterile, and must be properly －5－

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sterilized before use. Each clip must be held with the specified clip applier. Each clip applier is etched to read; e.g. “FOR (TYPE OF CLIP) Only”. When holding the clip, it must be verified that the spring of the clip is correctly placed in the holding jaws of the clip applier as shown in [Figure 2]. Improper holding of the clip may cause damage or ejection from the clip applier. As this may present a risk during surgery, ensure correct holding of the clip.

[Figure 2]

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・Do not hold the clip in angled positions. ・‌If the spring of the clip is not properly held with the holding jaws of the clip applier, the clip may slip or spring out from the jaws. This may also damage the spring of the clip, and there is a risk of breakage and reduced holding force, which may prevent closure of the targeted cerebral blood vessels. It is recommended that doctors record the type, lot, and serial number of the clip used in the operation record for each patient. To support traceability, Patient/Trace labels are included in the clip package.

9. Contraindications and Prohibitions

1) Prohibition of reuse This clip is for single use only. The clip must be discarded once the blades of the clip have been opened or the clip has come into contact with the blood or tissue of a patient. Reuse may cause breakage －7－

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of clips and may cause injury or infection. 2) Prohibition of use for unintended purposes This clip should not be used for purposes other than indication for use. 3) ‌To prevent changes in the clips closing force or in the mechanical features of the clip when it is handled, only use the exclusive clip applier. Do not use clip appliers from other manufacturers. 4) ‌Do not open the blades of clip directly with fingers. This may cause corrosion or alter the proper holding force. The blades of clip should be opened only when spring of the clip is placed in the proper position inside the clip applier. 5) ‌Modifying or adulteration of this clip is not allowed. 6) ‌In order to avoid a galvanic current, do not use this clip with implants from other manufacturers or with implants made of different materials. A galvanic current may cause corrosion and weaken the holding force. －8－

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7) ‌This clip must not be used in patients with serious allergies to metals or exogenous materials. 8) ‌This clip must not be used in patients with infectious diseases or sepsis as a complication. 9) ‌This clip must not be sterilized using low-temperature hydrogen peroxide gas plasma. This clip is not compatible with sterilization using low-temperature hydrogen peroxide gas plasma. [Sterilization using such method may cause surface color deterioration and affect its characteristics.]

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10. Warning

1) ‌It is recommended the patient is informed about the procedure and characteristics of this clip. 2) ‌Closing status of the blades of clip should be verified immediately following surgery. [The most serious adverse events that may be reported in conjunction with this clip include displacement of the clip, slip-out of the clip, ejection of the clip from the clip applier, clip fracture, laceration of a cerebral aneurysm, cerebrovascular injury, hemorrhage, death, etc. In addition, in consideration of the structure of the clip, risk of failures/adverse events may be increased by applying only the tips of clips, especially the ones with long blades, to the target tissue.] 3) ‌Handling of this clip: Rough handling of this clip may cause deformation or damage to the clip and may harm the patient.

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11. Use of MRI

MR Conditional

Non-clinical testing demonstrated that this clip is MR Conditional. A patient with this clip can be scanned safely in an MR system under the following conditions: ･Static magnetic field of 1.5 tesla or 3 tesla, only ･‌Maximum spatial gradient magnetic field of 1,000 gauss/cm (10-T/m) ･‌M aximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode Under the scan conditions defined, this clip is expected to produce a maximum temperature rise of 2.4°C (4.32℉) after 15-minutes of continuous scanning (i.e., －11－

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per pulse sequence). In non-clinical testing, the image artifact caused by this clip extends approximately 25-mm from this clip when imaged using a gradient echo pulse sequence and a 3-Tesla MR system. NOTE: ‌Do not take the clip applier into the MR environment. The clip applier contains material which has been determined to be MR Unsafe.

12. Caution

Use of this clip is restricted to surgeons with proper training in the use of this clip.

13. Defects and Adverse Events 1) Serious adverse events ・Displacement of the clip (slippage) ・Ejection of the clip from clip applier ・Breakage of the clip －12－

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・Rupture of a cerebral aneurysm ・Cerebrovascular injury ・Hemorrhage ・Death 2) Other adverse events ・Infection of surgical wound ・General surgical complications ・‌Delayed clip displacement due to the application of magnetic field ・Occlusion of adjacent blood vessel ・Foreign body reaction

14. Storage – Care and Handling

This clip is prepared in a non-sterile package and should be stored in its package in a cool, dry, and secure location. Do not use any clip applier other than the exclusive clip applier. Handling of this clip should be minimized to reduce －13－

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contamination or damage.

15. ‌Validated Cleaning and Sterilization Procedure

This clip is supplied non-sterile. Therefore, this clip must be sterilized by the users (healthcare professionals) prior to surgery using validated sterilization processes in accordance with guidelines stipulated by the government. Proper sterilization and handling of this clip is important for assuring that the clips meet sterile specifications prior to surgery as an aid in minimizing the occurrence of infection in the surgical patient. Other procedures for minimizing contamination in the operating room, including the use of a surgical unit with laminar flow equipment at the doctor’s discretion, are also important. Sterilization equipment should be validated to assure that it sterilizes specific load configurations properly. The end user is responsible to validate the sterilization process in －14－

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the individual sterilizer and assure the sterility. Sterilization equipment should be cleaned and maintained in accordance with standardized operating procedures specified by its manufacturer. Clean and sterilize the clip applier according to the clip applier instruction manual. This clip and instruments must be cleaned to reduce bioburden before first sterilization and resterilization. Do not use chlorine-based solutions when cleaning this clip. This could cause metallic corrosion. 1) Cleaning Put the clip in the designated Sugita Clip Case or Sugita Clip Tray (hereinafter this is called "clip case or tray") and close the lid. <In case of using Ultrasonic cleaner> (1) ‌Fully immerse the case (tray) in the water (tap water) of the washing tank.

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(2) Ultrasonic cleaning Cleaning time: 15 minutes or more ‌Detergent: Neutral enzyme type detergent (Diluted concentration 1.0%) (3) Rinsing ・‌Make sump water with running water, immerse the case (tray) completely in water (tap water or deionized water), shake the case (tray) 5 times up and down. ・‌Renew the water and shake the case (tray) 5 times up and down in the water again. ・‌Perform a series of rinsing operations three or more times in total. (4) Dry thoroughly. ‌Recommended drying condition: 110 °C (230℉), 30 minutes or more

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<In case of using washer disinfector (automatic washing)> Stage Procedure

Temperature Time Quality of water [°C (℉)] [min]

I

Preclean ＜25 (77)

3

Tap water

II

Washing 55 (131)

10

Tap water

III

Rinsing ＜25 (77)

4

Deionized water

IV

Hot water disinfection

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Deionized water

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V

Drying

Remarks －

Alkaline detergent (such as cleaning agent for aluminum) Diluted concentration 0.5%

Set rinsing process program as "1 time (1 minute) × 4 times = 4 minutes" Follow the program of the device.

2) Inspection Check clips visually one by one and do not use if the following abnormalities are found. ・Damage ・Deformation ・Corruption ・‌Inappropriate blade position (deviation, clearance, tip unevenness, etc.) ・Remaining dirt －17－

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Since the color of the surface may be faded in repetitive processing, do not use clips that cannot be clearly distinguished with color coding. 3) Packaging Place clip in the designated clip case or tray and close the lid. Then pack the case (tray) containing the clip using standard medical packaging material (non-woven fabric or sterilized bag) with protective sterile barrier complying with ISO 11607 for steam sterilization.

- Sterilization -

<Validated Sterilization Method> Standard followed

ISO 17665-1

Pre-vacuum steam sterilization (Autoclave sterilization)

Sterilization method Sterilization conditions

Sterilization temp. 132°C / 270℉*

Retention time

4 minutes or more

Drying time

20 minutes or more

3 minutes or more 20 minutes or more 134°C / 273℉* *A  ccording to the Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (Update: May 2019)

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Do not sterilize using low-temperature hydrogen peroxide gas plasma. It may cause discoloration and/or deformation. With a high-pressure steam sterilizer that has been confirmed to function properly, the validation of sterilization is verified by a medical institution, sterilization conditions with a proven effectiveness shall be applied.

- Storage -

Do not store the clip in high temperatures, or in areas with high humidity and/or where the temperature varies. Please store the clip in clean dust-free and dry area.

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