Directions for Use of GEISTER Surgical Instruments ...

First use of new Surgical Instruments 

Every instrument must be cleaned and sterilised before it is used.

Caution

The instruments may only be used for their intended purpose in the surgical specialties by educated and qualified personal. The surgeon shall be responsible for the propper selection of the instruments for each application, for obtaining the appropriate training, knowledge and experience,  and for their operative use.  

Geister Medizintechnik GmbH as manufacturer and seller cannot accept any liability for immediate or consequential damages caused by inappropriate application and use or by inappropriate sterilisation and maintenance of the instruments.

If instruments are repaired by any companies or persons not authorized by Geister Medizintechnik GmbH to do so, all warranties are becoming null and void.

Carefully examine each surgical instrument for breaks, cracks, deformations and malfunctions before use. It is especially essential to check areas such as blades, points, ends, stops and snaps as well as movable parts. Instruments that are worn out, corroded, deformed, porous or damaged in any other way must be sorted out.

Storage

Instruments should be stored in a clean, dry, moisture free area. Instruments should be stored individually in their shipping carton or in a protective tray with partitions. Protect tips, edges etc.  with tubing, protecting caps, gauze or fabric. Make sure that no chemicals are close to or in the storage  area.

Used materials

Stainless steel as per DIN EN ISO 7153-1
Pure titanium as per DIN ISO 5832-2
Titanium alloys as per DIN ISO 5832-3
Light metal (Aluminium) as per DIN EN 573-3

Steel instruments

The high-grade steels (rustproof, stainless) that are used for manufacturing surgical instruments create due to the chemical composition specific passive layers as protective surfaces. Those steels however are only to a certain extent resistant against attacks of chloride ions and aggressive waters! Chloride ions mainly cause pitting, but can also cause stress corrosion cracking. The greatest danger is water in which considerable quantities of common salts (sodium chloride) are dissolved.

Titanium instruments

Instruments made from pure titanium or titanium alloy can be handled and treated like steel instruments and no special precautions gave to be taken. Some titanium instruments are completely or partially anodised in blue color for identification purpose. 

Aluminium  instruments

Only non-alkaline, neutral cleaning agents in combination with fully demineralized water must be used. Otherwise damages to the anodized surface are possible. Alkaline cleaning causes marks and color fading on the surface particularly of colored instruments already after just a few cycles.

In addition to the endeavours undertaken by the manufacturer with regards to the selection of the proper materials and its careful processing, the user has to ensure continuous and proper care of the surgical instruments as well as proper preparation, cleaning and sterilisation.

We recommend the following methods and procedures for the preparation of our reusable surgical instruments:

Manual Cleaning 

The instruments must be disinfected and cleaned immediately after use. Contaminations on the instrument must not get dry or encrusted, as this could cause difficulties in cleaning and desinfection.

The following points are to be observed:

1.Solutions used for the mechanical cleaning must be prepared strictly following the  instructions given by the manufacturer
2.For the cleaning of cannulas and dead-end holes a suitable brush must be used so  any area can be reached.
3.Remove blood and all contaminations with a soft brush  and a mild neutral or alkaline (except for Aluminium!) detergent. Never use metal brushes or metal sponges for cleaning. 
4.To ensure proper function of the instrument, make sure that all movable parts are thoroughly cleaned.
5.Clean instruments with hinges and box-locks in open as well as in closed position.
6.Detach instruments for cleaning as far as possible.
7.Pay special attention to the cleaning of slots, gaps, ratchets, box-locks, cannulations and dead-end holes
8.Surgical instruments should be placed in proper carriers, such as perforated trays, wire baskets etc.

Ultrasonic treatment

For ultrasonic treatment instruments should be placed in open condition on proper perforated trays or in wire baskets. Please ensure to avoid any "wave shadows" or covering surfaces caused by wire baskets or perforated trays or by large or bulky instruments.

Warm water without any additives does not have a satisfactory cleaning result and therefore a suitable cleaning agent should be added. Follow strictly the instructions given by the manufacturers regarding concentration.

The temperature of the detergents in the ultrasonic basin should range between 104°F and 113°F (40°C and 45°C). If the temperature is below 104°F (40°C) no cleansing effect is guaranteed. If the temperature is above 113°F (45°C), the proteins may coagulate. 

A too dirty solution in the ultrasonic basin decreases the cleaning effect. Therefore, the solution should be renewed at intervals according to the instructions given by the manufacturer.

Ultrasonic waves for 3 minutes at a frequency of a least 35 kHz have proved to be sufficient in everyday use (Follow manufacturers’ instructions.)

After ultrasonic treatment all instruments must be rinsed and checked for loose parts (e.g. screws etc.). For rinsing fully demineralised or distilled water must be used to avoid water spots.

Chemical desinfection

1.The temperature of soaking solutions used for chemical desinfection should not exceed 140°F (60°C).
2.Thinnings have to be made using fully demineralized or distilled pure water only. Detergent or cleaning agent must not be added. Follow precisely the instructions given by the manufacturer of the solution regarding dosage and induction time. 
3.The desinfection solutions must be refreshed daily. Reusing them can cause an increase of the dosage through evaporation (->corrosion risk) or a too high contamination level (->corrosion risk and reduced efficiency).
4.After chemical desinfection all instruments must be rinsed with pure flowing water. To avoid water spots only fully demineralized or distilled water must be used. 
5.Dry surgical instruments immediately after each cleaning, desinfection and rinsing cycle.

Machine Cleaning and Desinfection

1.Machine cleaning and desinfection is always a preferable method compared to manual cleaning since machine procedures can be standardized.
2.Follow the operating and loading instructions provided by the manufacturer of the washing machine. Use only the detergents and cleaning agents recommended by the manufacturer for the specific purpose.
3.Hinged and box-lock instruments must be loaded and cleaned in open condition. Place instruments into the machine in a way that allows the water to flow out of cannulations and dead-end holes.
4.Take instruments apart as much as possible for cleaning.
5.Machine cleaning and desinfection is only suitable for instruments with long or thin cannulations if the hot desinfeczion solution can actually flow through them.
6. When removing instruments from the washing machine, pay special attention to the proper cleaning of slots, gaps, ratchets, box-locks, cannulations and dead-end holes. Check for any visible remaining contaminations. If necessary clean manually and/or repeat cycle.

Attention: Thermal disinfection according the national requirements in respect of the A_0-value

Steam sterilization / Autoclaving

Sterilize all instruments before use.

When using autoclaves for sterilization of surgical instruments, it has to be strictly ensured that the steam used is absolutely free of foreign substances such as corrosive particles or dirt to avoid subsequent corrosion or dirt (scum) deposit. Please observe strictly the instructions for use given by the manufacturers of autoclaves.

Do not use any damaged instruments.  

Hints for the sterilization of the instruments with sterilization container systems

- Use 1 or 2 layer of the OT cloth inside of the sterilization container as a wrap around the basket to absorb the humidity at the bottom in particular. 
- Do not wrap the sterilization container on the outside with paper or textile filters during the sterilization cycle. This would cover the holes, press the filter inside and does not allow for the steam to move in and out properly. Also drying is not possible in proper manner.
- Replace singel use paper filters after each and textile filters after 60 cycles. 
- A drying cycle time of 20 minutes after autoclave cycles must be observed by all means! It’s not allowed to skip this dry time, because it’s crucial! After this the sterilization container and the goods should be quite dry inside. This should be tested. 
- Remaining humidity in sterilization container and subsequent storage in this way can cause brownish discoloration or rust on instruments.
- IMPORTANT! Loading weight of 1/1 sterilization containers shall be not more than 10 kgs! The loading weight of the smaler sterilization containers shall be appropriate less than the 1/1 sterilization containers.
- For Crutchfield-Jacob contaminationed instruments sometimes the holding time at the sterilization cycle will be increase to a higher time of 30 min. This is known to cause problems on many instruments. It’s better to use a proper disinfectant before and use common holding time for instruments

Equipment and methods used for cleaning, desinfection and sterilization have to be in accordance with the following standards and recommendations:

Repeated instrument preparation has no significant influence on the lifetime of the surgical instrument. The lifetime of the instrument is usually determined by wear and tear or mutual damage during use.

Maintenance of instruments

Maintenance of surgical instruments means lubrication with physiologically inert instrument oil (acc. to DAB 8 or Ph.Eur. or Usp) particularly of the joints. Make it a basic rule to thoroughly lubricate surgical instruments prior to checking for function. All movable parts (joints) and cutting blades of scissors have to be lubricated. This avoids metal abrasion when checking for function. Lubricants used must guarantee, that even after frequently repeated use a “sticking” of joints through a multiplying effect is avoided.