Acculan 3Ti Dermatome GA670 Instructions for Use April 2009

Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 Note Keep instructions for use in Acculan® 3Ti folder!

Legend 1 Dermatome 2 Nut 3 Sliding surfaces 4 Trigger (for controlling the oscillation frequency) 5 Safety catch 6 Blade cover 7 Clamping lever 8 Sliding surfaces 9 Blade guide peg 10 Pusher dog 11 Flap tabs 12 Flaps 13 Surface 14 Setting lever 15 Lock (of setting lever) 16 Dial wheel 17 Roll pin 18 Flap rod 19 Guide slots 20 Sterile funnel 21 Cover 22 Cover release button 23 Battery 24 Dermatome blade 25 Battery removal device 26 Color code

Symbols on product and packages Caution: See documentation supplied with the product

Classification Type BF

Labeling of electric and electronic devices according to directive 2002/96/EC (WEEE), see Disposal

Oscillation frequency control

Keep this product dry!

Service label on battery (base) Notice indicating the next scheduled service (date) by an international B. Braun/Aesculap agency, see Technical Service

Direction of rotation to undo the nut

2

Direction of rotation to tighten the nut

Service label on Acculan® 3Ti Dermatome Notice indicating the next scheduled service (date) by an international B. Braun/Aesculap agency, see Technical Service

4.3

5. 5.1 5.2 5.3 5.4 5.5 5.6 5.7

Contents 1. 2. 2.1 2.2 2.3 2.4 3. 4. 4.1

4.2

Safe handling and preparation ... 4 Product description ... 4 System components ... 4 Components necessary for use ... 4 Intended use ... 5 Operating principle ... 5 Preparation ... 5 Working with the Acculan® 3Ti Dermatome .. 5 System set-up ... 5 Installing the flap rod of the Acculan® 3Ti Dermatome... 5 Dismantling the flap rod of the Acculan® 3Ti Dermatome... 5 Connecting the accessories... 6 Inserting the dermatome blade... 6 Removing the dermatome blade... 7 Inserting the battery ... 7 Removing the battery ... 9 Intraoperative battery change... 10 Protection against inadvertent activation... 11 Intraoperative storage ... 11 Function checks ...12

5.8 5.9 5.10 5.11 5.12 6. 7. 8. 9. 10. 10.1 11. 12.

Safe operation ...12 Adjusting the cutting depth of the Acculan® 3Ti Dermatome... 12 Adjusting the cutting width of the Acculan® 3Ti Dermatome... 12 Operating the Acculan® 3Ti Dermatome... 13 Taking skin grafts... 13 Validated processing procedure ...14 Single-use products ...14 General notes ...14 Preparations at the place of use ...15 Preparation prior to cleaning ...15 Cleaning/Disinfecting ...16 Manual cleaning/disinfecting ...17 Manual cleaning and wipe disinfection ... 17 Mechanical cleaning/disinfecting ...18 Mechanical alkaline cleaning and thermal disinfecting... 19 Inspection, maintenance and checks ...19 Packaging ...19 Sterilization method and parameters ...20 Sterilization for the US market ...20 Storage ...20 Maintenance ...21 Troubleshooting list ...22 Technical Service ...23 Accessories/Spare parts ...23 Technical specifications ...24 Ambient conditions ...24 Disposal ...25 Distributor in the US/Contact in Canada for product information and complaints ...25

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 1.

Safe handling and preparation

CAUTION Federal law restricts this device to sale by or on order of a physician! ¾ Prior to use, check for proper condition and functioning of the product. ¾ Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ¾ To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Observe all safety information and maintenance advisories. – Only combine Aesculap products with each other. – Follow the application advisories acc. to standard, see “Extracts from relevant standards”. ¾ Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge or experience. ¾ Keep the instructions for use accessible for the user. ¾ Always adhere to applicable standards. ¾ Follow the instructions for use of the Acculan® 3Ti Charger, TA022160.

2.

Product description

2.1 System components Designation

Art. no.

Acculan® 3Ti Dermatome

GA670

Cover

GA675

Sterile funnel

GA678

Battery

GA666

Instructions for use

TA013000

Instructions for use of battery GA666

TA011867

2.2 Components necessary for use Designation STERILIT® Power Systems lubricator (50 ml)

Art. no. drip GA059

Acculan® 3Ti Dermatome

GA670

Cover

GA675

Sterile funnel

GA678

Battery

GA666

Charger

GA677

Dermatome blade

GB228R

STERILIT® Power Systems oil spray GB600 (300 ml)

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2.3 Intended use

4.

Working with the Acculan® 3Ti Dermatome

The Acculan® 3Ti Dermatome is used to produce skin grafts in dermatologic/traumatologic surgery.

2.4 Operating principle In the Acculan® 3Ti Dermatome, the rotational speed of the motor is converted, through reduction gearing and an eccentric drive unit, directly and with minimum loss into oscillating movement of the dermatome blade.

3.

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. ¾ Prior to use, inspect the Acculan® 3Ti Dermatome and its accessories for visible damage. ¾ Only use Acculan® 3Ti Dermatomes and accessories that are in perfect condition.

4.1 System set-up Installing the flap rod of the Acculan® 3Ti Dermatome ¾ Attach flaps 12 on flap rod 18 down to the onset of the rear surface. Observe the symbol on the face of the thread. ¾ Screw the nut 2 counterclockwise onto the thread of flap rod 18 (left-handed thread). ¾ Screw the nut 2 down to the edge of the visible surface. ¾ Insert and twist flap rod assembly 18 in guide slots 19 at the lateral surfaces. ¾ Push flap rod 18 sideways to the positive stop, so that the cross pin of flap rod 18 is seated in guide slot 19. ¾ Tighten nut 2 by turning it counterclockwise.

Dismantling the flap rod of the Acculan® 3Ti Dermatome

2

19

12

18

19

Fig. 1 Flap rod dismantled ¾ Loosen the nut 2 by turning it clockwise (lefthanded thread).

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 ¾ Screw the nut 2 back to the end of the visible surface. ¾ Press on nut 2 and push flap rod 18 approx. 4 mm to one side. ¾ Twist flap rod 18 until it can be removed. ¾ Remove flap rod 18. ¾ Slide off flaps 12 from flap rod 18.

Inserting the dermatome blade

DANGER

Connecting the accessories

DANGER

Risk of injury due to unapproved configuration using additional components! ¾ For all components, ensure that their classification (e.g. Type BF or Type CF) is the same as that of the device in the respective application.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Also, all equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, EN 60601 for electromedical devices). All configurations must meet the system standard IEC 60601-1-1. The person connecting the units is responsible for the configuration and must ensure compliance with system standard IEC 60601-1-1 or equivalent national standards. ¾ Please contact your B. Braun/Aesculap Partner or Aesculap Technical Service, address see Technical Service with any inquiries in this respect.

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DANGER

Risk of infection and contamination due to torn or cut surgical gloves! ¾ Avoid contact with the cutting edge when inserting the dermatome blade. Risk of injury and material damage due to inadvertent activation of the dermatome while inserting the dermatome blade! ¾ Prior to inserting the dermatome blade, engage the safety catch.

¾ Engage safety catch 5. ¾ Push both clamping levers 7 in the direction of the arrows. Blade cover 6 is now unlocked. ¾ Open blade cover 6 in the direction of the arrow. ¾ Safely insert dermatome blade 24 in pusher dog 10 and blade guide peg 9, see Fig. 2. ¾ Close blade cover 6. ¾ Tighten both clamping levers 7 so that roll pin 17 engages in the recess of clamping lever 7.

Removing the dermatome blade

Inserting the battery Damage to, or destruction of the batteries due to processing! ¾ Do not sterilize batteries.

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CAUTION

6

10 7

20 1

Fig. 2

Safe insertion and removal of the dermatome blade ¾ Release both clamping levers 7. ¾ Open blade cover 6. ¾ Remove dermatome blade 24 from pusher dog 10 and blade guide peg 9.

Fig. 3 Installing the sterile funnel ¾ Hold dermatome 1 so that compartment is facing upwards. ¾ Install sterile funnel 20, see Fig. 3.

the

battery

7

Aesculap Power Systems

Acculan® 3Ti Dermatome GA670

23 20

20

26

Fig. 4

Installing the sterile funnel in the battery compartment ¾ Have a helper insert the (unsterile) battery 23 through sterile funnel 20 into the battery compartment (observe color code 26). Note Once the battery is in the battery compartment, a series of acoustic blips will signal that the dermatome is ready for operation. Note The color code on the floor of the battery compartment must match the color code at the bottom of the battery.

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Fig. 5 Removing the sterile funnel ¾ Once the battery has been inserted, have a helper remove sterile funnel 20 (unsterile), see Fig. 5.

Removing the battery

22

21 CAUTION

Damage to the dermatome and/or battery caused by knocking the unit against hard objects! ¾ Only tap the dermatome against the palm of the hand. ¾ To remove the battery, only ever knock the motor unit against the palm of the hand.

Fig. 6 Mounting the battery compartment cover ¾ Mount cover 21 (sterile) so that it engages at both cover release buttons 22, see Fig. 6. Note Sterility of the unit is ensured only if cover is mounted correctly.

Fig. 7

Tapping the dermatome

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 Intraoperative battery change Note The function checks must be carried out prior to each surgical application of the unit and after each intraoperative battery change! Battery removal device is used for intraoperative battery changes ensuring that sterile conditions are safely maintained.

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1

Fig. 8

Removing the battery

Note The battery must be removed after the surgical operation and prior to processing. Note Battery removal device can be used to facilitate the removal of the battery, see Fig. 9! ¾ Hold dermatome 1 with the battery compartment facing upward. ¾ Simultaneously press both cover release buttons 22 at cover 21 and remove cover 21. ¾ With one hand, completely envelope the battery compartment at its lower end, see Fig. 7. ¾ Tap battery 23 against the palm of the other hand and remove the battery from the battery compartment, see Fig. 8.

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Fig. 9 Using the battery removal device ¾ Hold dermatome 1 with the battery compartment facing upward and remove cover 21. ¾ Mount sterile battery removal device 25, see Fig. 9.

¾ Slightly shake dermatome 1 with battery removal device 25 mounted and the battery compartment facing downward. Battery 23 smoothly slips into battery removal device 25. ¾ Hand battery removal device 25 containing the discharged battery 23 to an unsterile helper. ¾ Insert charged battery 23, see Inserting the battery.

Intraoperative storage

Protection against inadvertent activation Fig. 11 Storing the dermatome ready for operation in its Eccos® holder

4 1 5

Fig. 10 Engaging the safety catch To prevent inadvertent activation of dermatome 1 while replacing the dermatome blade, trigger 4 must be locked. ¾ To lock trigger 4: Move safety catch 5 to its OFF position, see Fig. 10. Trigger 4 is locked. Dermatome 1 cannot be activated. ¾ To unlock trigger 4: Move safety catch 5 to its ON position, see Fig. 10. Trigger 4 is unlocked. Dermatome 1 can be activated.

Note Eccos® holder can be used for intraoperative storage of the dermatome. The dermatome cannot be processed in this position. For the correct processing position, see Mechanical cleaning/disinfecting! ¾ Engage safety catch 5 against inadvertent activation, see Protection against inadvertent activation. ¾ Fold back the clamp of the Eccos® holder. ¾ Place dermatome 1 in the Eccos® holder.

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 4.2 Function checks Note The function checks must be carried out prior to each surgical application of the unit and after each intraoperative battery change! ¾ Follow the advisories/procedure for inspection, maintenance and checks, see Inspection, maintenance and checks. ¾ Ensure that a dermatome blade is correctly seated in the dermatome. ¾ Ensure that there is a battery in the battery compartment. ¾ Check that the roll pin is securely seated. ¾ Check that the dermatome blade is securely seated. ¾ Briefly activate the dermatome at maximum oscillation frequency.

Adjusting the cutting depth of the Acculan® 3Ti Dermatome Note The skin condition (e.g. due to age) of the patient must be considered when adjusting the cutting depth (graft thickness)! ¾ Set the cutting depth at setting lever 14. Lock 15 of setting lever 14 prevents inadvertent changes of the cutting depth setting. ¾ Read the cutting depth (graft thickness) on dial wheel 16 (1/10 mm gradation). ¾ Follow the troubleshooting advisories/procedure, see Troubleshooting list.

Adjusting the cutting width of the Acculan® 3Ti Dermatome

4.3 Safe operation

WARNING

Risk of injury caused by inadvertent activation of the motor! ¾ Secure dermatomes that are not actually used against inadvertent activation. Risk of injury and/or malfunction! ¾ Always carry out a function check before using the product.

WARNING

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WARNING

Risk of injury/cuts by the dermatome blade if the flaps are opened incorrectly! ¾ Always use the flap tabs for lifting the flaps.

Note The width of the skin graft will be approx. 2 mm less than the cutting width set by the flaps.

Taking skin grafts

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11

Fig. 12 Safely lifting the flaps ¾ Set the required cutting width by opening the appropriate number of flaps 12. ¾ Safely lift flaps 12 by pressing flap tabs 11. ¾ Completely open flaps 12 until they engage in their end positions (flap width = 8 mm).

Before using the Acculan® 3Ti Dermatome for the first time, the user should carry out some test cuts on a specimen to make themselves familiar with the operation of the device. ¾ Stretch flabby skin. ¾ With the sliding surface in level contact with the skin, push forward dermatome 1 in a smooth movement, applying gentle pressure. Be careful not to cant dermatome 1. ¾ For very thin grafts, use a forceps, from time to time, to lay up the resected portion of the graft on surface 13. ¾ Switch off the motor and extract the fresh graft from the dermatome. - or ¾ Lower the handle and cut off the skin graft with dermatome 1.

Operating the Acculan® 3Ti Dermatome Note The low howling noise heard during startup of the Acculan® 3Ti Dermatome is normal for this product! ¾ Press trigger 4. The dermatome runs at the continuously controlled oscillation frequency.

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 5.

Validated processing procedure

Note Adhere to national statutory regulations, international standards and guidelines, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of the products. Note Mechanical processing should be preferred over manual cleaning, as mechanical processing produces better and more reliable cleaning results. Note Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net Note Successful processing of this medical product can only be ensured if processing is performed through a validated processing procedure. The user/processor is responsible for the validation. Due to process tolerances, the manufacturer’s specifications can only serve as an approximate guide for assessing the processing procedures applied by the individual operator/processors.

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5.1 Single-use products

WARNING

Risk to patients due to damaged, broken or contaminated products! These products are intended for single use only! ¾ Do not reprocess the product.

Designation

Art. no.

Dermatome blade

GB228R

5.2 General notes Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion of stainless steels. To avoid this, the time interval between application and processing should not exceed 6 h, and neither fixating precleaning temperatures >45 °C nor any fixating disinfecting agents (active ingredient: aldehyde, alcohol) be used. Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration of laser inscriptions on stainless steel surfaces, regarding visual reading and machinereadability of the inscriptions.

Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. To remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried thoroughly. Only process chemicals that have been tested and approved (e.g. VAH/DGHM or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All process parameters specified by the chemical’s manufacturer, such as temperatures, concentrations and exposure times, must be strictly observed. Failure to do so can result in the following problems: • optical changes to the material, e.g. fading or discoloration of titanium or aluminum. For aluminum, pH >8 in the application/process can already cause visible surface changes. • material damage such as corrosion, cracks, fracturing, premature aging or swelling. ¾ Do not use process chemicals that cause stress cracking or brittleness of plastic materials. ¾ Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, Publications Red Brochure – Proper maintenance of instruments.

5.3 Preparations at the place of use ¾ Remove all batteries from the Acculan® 3Ti Dermatome, see Removing the battery. ¾ Open the clamping levers and remove the dermatome blade. ¾ Disassemble the product immediately after use, as described in the respective instructions for use. ¾ Remove visible surgical residues as completely as possible, using a lint-free wet wipe. ¾ Dismantle the flap rod of the dermatome, see Dismantling the flap rod of the Acculan® 3Ti Dermatome.

5.4 Preparation prior to cleaning ¾ Have the product dry in a disposal container and ready for immediate cleaning and disinfecting within 30 min after use.

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 5.5 Cleaning/Disinfecting

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ¾ Use cleaning and disinfecting agents according to the manufacturer’s instructions. The cleaning and disinfecting agents must - be approved for plastics and high-grade steel, - not attack softeners (e.g. silicone). ¾ Observe specifications regarding concentration, temperature and exposure time. ¾ Do not exceed the maximum allowable cleaning temperature of 55 °C.

¾ Do not clean the motors/handpieces in an ultrasound bath and do not immerse them in any fluid. Let any fluid that penetrates into the product drain out immediately to avoid the risk of corrosion/ malfunctioning of the product.

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5.6 Manual cleaning/disinfecting Manual cleaning and wipe disinfection Stage

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

≥1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD–W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized) Room Temperature

Stage I

Stage III

¾ Clean the product under running tap water, using a suitable cleaning brush if necessary, until all visible residues have been removed from the surfaces. ¾ Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ¾ Make certain the product is positioned in such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered inadvertently.) ¾ Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion.

¾ Wipe all surfaces of the product with a single-use disinfecting wipe.

Stage II

Stage IV ¾ After the specified exposure time (of at least 1 minute), rinse the disinfected surfaces under running FD water. ¾ Hold the product in such a way that water cannot enter it e.g. through couplings or adapters. ¾ Allow water to drip off for a sufficient length of time. Stage V ¾ Dry the product with lint-free tissue or medicalquality filtered compressed air.

¾ Dry the product with lint-free tissue or medicalquality filtered compressed air.

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 5.7 Mechanical cleaning/disinfecting Note Categorically, the disinfector must be of tested and approved effectiveness (e.g. DGHM or FDA approval or CE mark according to DIN EN ISO 15883). Note For thermal disinfection, always use fully desalinated (demineralized) water. Ensure that Ao is >3 000 for the process. Note The disinfector used for processing must be serviced and checked at regular intervals.

Fig. 13 Tray with product in Eccos® holder ¾ Dismantle the flap rod, see Dismantling the flap rod of the Acculan® 3Ti Dermatome. ¾ Store flaps and nut separately. ¾ Ensure that the blade cover is kept open through the entire processing procedure. ¾ Use Eccos® tray GB256R fitted with Acculan® 3Ti holders, or mount appropriate holders (e.g. Eccos® holder GB498R) in a suitable tray (instructions for use TA009721 for Aesculap Eccos® storage system).

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¾ Insert the product in its proper position, with the trigger pointing upwards, in Eccos® holder GB498R. Place the battery compartment over the clamp and swivel the device into the Eccos® holder so that the trigger points upward, see Fig. 13.

Mechanical alkaline cleaning and thermal disinfecting Machine type: Single-chamber washer/disinfector without ultrasound Stage

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

BBRAUN HELIMATIC CLEANER alkaline with tensides, application solution 0.5 %

III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

V

Drying

-

-

-

D–W: FD–W:

according to disinfecting program

Drinking water Fully desalinated water (demineralized)

5.8 Inspection, maintenance and checks Note Aesculap recommends lubricating the flap rods, flaps, sliding surfaces and other moving parts, e.g. trigger, cover lids etc., with STERILIT® Power Systems oil spray GB600/STERILIT® Power Systems drip lubricator GA059 prior to sterilization! Remove excess oil with a lint-free wipe. ¾ Allow the product to cool down to room temperature. ¾ Inspect the product after each cleaning and disinfecting cycle to be sure it is clean, functional and undamaged. ¾ After cleaning/disinfecting, inspect all surfaces and difficult to access spots on the product for visible dirt or debris. ¾ Check the product for any damage, atypical running noise, overheating or excessive vibration. ¾ Set aside the product if it is damaged.

5.9 Packaging ¾ Follow the instructions for use of the respective packaging and holders (e.g. instructions for use TA009721 for the Aesculap Eccos® storage system). ¾ Insert the product in its proper position in the Eccos® holder, or put it on a tray in such a way that the product is protected against damage. Make certain that all cutting edges are protected. ¾ Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ¾ Ensure that the packaging provides sufficient protection against recontamination of the product (DIN EN ISO 11607).

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Aesculap Power Systems

Acculan® 3Ti Dermatome GA670 5.10 Sterilization method and parameters Damage to, or destruction of the batteries due to processing! ¾ Do not sterilize batteries.

5.11 Sterilization for the US market • Aesculap does not recommend the device sterilized by flash or chemical sterilization. • Sterilization may be accomplished by steam autoclave in a standard prevacuum cycle. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:

CAUTION Note The product may only be sterilized in disassembled condition. ¾ Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent. ¾ Validated sterilization process – Disassemble the product – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization through fractionated vacuum process at 134 °C/2 bar; holding time 5 min. ¾ When sterilizing several products at the same time in one steam sterilizer: Make certain that the maximum allowable load capacity of the steam sterilizer, as specified by the manufacturer, is not exceeded.

Aesculap Orga Tray/Sterilcontainer (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Pre-vacuum

270 °F- 275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap Sterilcontainer cleared by FDA for the sterilization and storage of these instruments. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.

5.12 Storage ¾ Store sterile products in germ-proof packaging under dust protection in a dry, dark and temperature-controlled room. ¾ Store sterile single-use products in germ-proof packaging in a dust-protected, dry, dark and temperature-controlled room.

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