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Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite 41-7200 Neurosurgery Retractor and Hand Stabilization Systems_EN A

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Instructions for use

Neurosurgery Retractor and Hand Stabilization Systems

Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49-7461-96624-0 FAX: +49-7461-96624-22 E-Mail: [email protected]

PRODUCT DESCRIPTION

The Geister Neurosurgery Systems are sets of various components that allow a surgeon to construct a support framework around an operative site that is then used to support retractors, various surgical instruments and the surgeon’s hands.

System Components Geister offers these products in either of 2 assortments (Standard and Deluxe) either of which is available in either Surgical-grade Stainless Steel or in MRI-Compatible Titanium. The chart on the opposite side details the contents of each.

Inspection Inspect all parts upon receipt, during the cleaning process and immediately before use. Test to see that any moving or turning parts move freely. Visually inspect for loose or missing parts, cracks and broken components. Any device with missing parts, cracks or broken components should not be used and returned to Geister for repair or replacement.

Cleaning These devices should be cleaned and sterilized upon receipt. After use, they should be cleaned according to hospital protocol for reusable surgical instruments. Follow instructions and warnings as issued by the manufacturer of any decontaminants, disinfectants and cleaning agents used. Suggested steps in the cleaning process include but are not limited to:

• Wherever possible, do not allow blood, debris or bodily fluids to dry on devices. For best results and to prolong the life of the device, reprocess immediately after use. If they cannot be reprocessed immediately, use enzymatic foam spray cleaner or deionized (distilled) water to help prevent soil from drying.


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• The Components are not designed to be disassembled. Do not attempt to

disassemble. • Prepare enzymatic detergent (such as Kenzyme™) according to

manufacturers’ recommendations at 40°C and soak device(s) for fifteen (15) minutes.

• Scrub the submerged device(s) with a soft bristled, non-metallic brush. Agitate the device(s) by hand while scrubbing. Maneuver any movable parts to loosen soil for one minute total, for each device.

• Rinse device(s) with warm tap water for thirty (30) seconds.

• Place device(s) into bath containing warm (38-49°C) water. Agitate the device(s) by hand for one (1) minute. Repeat two additional times.

• Sonicate device(s) for fifteen (15) minutes in 40°C water and a neutral P.H. detergent (such as Neutrad™). Prepare detergent according to manufacturers’ recommendations.

• Rinse the device(s) with clean tap water for one (1) minute.

• Dry the device(s) with a clean, lint-free cloth. • Re-inspect for loose or missing parts, cracks and broken components. Inspect

for visible soil or debris. Repeat cleaning procedure if the device(s) appear to be soiled.

• These devices should be lubricated after every cleaning. Any commercially available water soluble instrument milk or lubricant is acceptable. Follow instructions for lubricating surgical instruments as provided by the manufacturer of the lubricant used.

STERILISATION Minimum parameters for Pre-Vac cycles are 4 minutes at 132 Degrees C (270 degrees F). Validated hospital protocol for reusable surgical instruments including Gravity, Flash, Ethylene Oxide, Peracetic Acid (Steris) and Hydrogen Peroxide Gas Plasma (Sterrad) may also be used. Always follow the manufacturer’s recommendation for surgical instruments in the use of any sterilizing equipment or method.

SET-UP AND USE The following are meant as general guidelines only. Operating room personnel should be familiar with general set-up and should adapt the following to case-specific needs considering type of procedure, inicision site, position of surgeons and assistants. If the device is being used for the first time, the OR Staff is urged to do a “dry-run” with the surgeons and OR personnel expected to be present during surgery. The system is designed to be mounted on the frame work of skull clamps or on the Rail of the OR Table. • Mount the Primary Bars to the frame of the Scull Clamp or the OR Table Rail.

Tighten the jaws completely and test that each bar is firmly attached. The primary bars (Fig. 1) should be positioned to allow the secondary bars to create a roughly rectangular shape around the operative site.


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Fig. 1 Fig. 2 Fig. 3 Fig. 4

Fig. 5 Fig. 6 Fig. 7

• Attach either a Secondary Bar or a Floating Secondary Bar to each of the primary Bars. Position them in such a way as they form 2 sides of the rough rectangle around the operative site. This is shown in Figure 2. Be sure all components are tightened securely into position.

• Attach the 2 remaining Secondary Bars on Floating Secondary Bars so that the Rectangular shape around the operative site is created. Be sure all components are tightened securely into position. One possible configuration is shown by the ed shaded arms in Figure 3.

• Retractor Arms and Hand Rest(s) can the be attached to either the Primary Bar(s) or Secondary Bar(s) as needed. A possible configuration of the Retractor Arms (Blue) and Hand Rest (Green) is shown in Figures 4 and 5. Note in Figure 6 that one arm is holding the patty Tray and 2 of the arms are holding brain retractors (All in Yellow). Note The Flexible arms must be “Pretensioned”prior to use. See below.

• The completed set-up is Figure 7.

• Postoperatively, remove components in the opposite sequence.

Opening, Pretensioning and Using The Flexible Arms and Hand Rest The components featuring flexible components can all be placed, manipulated to their desired position and tightened to maintain that position. They are made up of a series of ball and socket joints which are held together by means of an internal steel cable. It is the tightening of a Tension Setting Knop that pulls the cable tight which in turn causes the ball an socket joints to lock in the desired position. However, to thoroughly clean and sterilize these devices, the ball and sockets must be opened slightly to allow steriland to get inside the ball and socket joints. This is referred to as “Opening for Cleaning”


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Figure 8 shows the first step. While holding the entire Clamp Assembly in the left hand, turn the Tension Setting Knop as far as possible counter-clockwise with the right hand. This assures that the cable is in the loosened position.

Step two (Figure 9) ist to hold the ball and sockets nearest the Clamp Assembly and turn the entire assembly counter-clockwise until you have created about ¼” gap in the ball and socket joints. Caution! Do not loosen the Clamp Assembly beyond the ¼” gap. This may result in the entire instrument becoming dissembled. If that happens, the device should be returned to Geister for reassembly. Prior to use in the OR, the “Opening” needs to be reversed with a process called “Pretensioning”. If upon receipt at the Mayo Stand, the sterile flexible arm is observed to have ball and socket joints that have space between them or “feel” loose, you must Zero the arm. As shown in Figure 10, while holding the ball an socket joints in the left hand, rotate the entire Clamp Assembly clockwise until you feel slight resistance. Then back off 1/3 to ½ a turn an arm is ready for use. Any of the arms may be made rigid by turning the Tension Setting Knob Clockwise until desired firmness is achieved. See Figure 11.

ROUTINE MAINTENANCE If inspection, cleaning and lubrication are done on a regular basis, no other routine maintenance should be required on these devices.

CAUTION When using this product in conjunction with any electrical device, care must be taken to ensure that the surgical table is properly grounded.

CAUTION Geister does not define the maximum number of uses appropriate for re-usable medical devices. The useful life of these devices is dependent on many factors


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including the method and duration of each use, and the handling between uses. Careful inspection and functional testing of the device before use is the best method of determining the end of serviceable life for the medical device.

LIMITED PRODUCT WARRANTY All Geister Retractor System Components are warranted to the original purchaser to be free from defects in material and workmanship for a period of one (1) year from the date of purchase. If this product proves to be defective, purchaser should obtain a Returned Goods Authorization from Geister and return it to the address above. Geister will repair or replace defective product at our option. Geisters liability under this limited warranty does not extend to abuse or misuse of the product.

FOR SERVICE OR REPAIR For any necessary service or repair, please contact your Geister Distributor or Geister Customer Service at the address shown above.

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