Miaspas miniTTA

Aesculap® Miaspas miniTTA

MiaspasAesculap miniTTA®

Retraction system legend 1 2 3 4 5 6

Intended use

Sliding element with locking screw (BV153R) Notched rod with opening (BV153R) Adjusting element with opening (BV153R) Rib retractor blade in lengths S and L (BV162R/BV163R) Adjusting element with notched rod (BV154R) Notched rod with opening for caudomedial diaphragm blade (BV154R) 7 Caudomedial diaphragm blade in sizes S, M and L (BV169R-BV171R)) 8 Handle for caudomedial diaphragm blade (BV413R) 9 Sliding blade for attachment of craniolateral lung blade (BV155R) 10 Craniolateral lung blade in lengths S, M and L (BV164R-BV166R) 11 Forceps with quick action ball lock for changing wound blades (BV399R) 12 Ratchet lever

The Miaspas miniTTA transthoracic retraction system is used in ventrolateral spondylodesis. This Aesculap modular retraction system allows for access to the thoracic and thoracolumbar segments of the spinal column. It is comprised of three modular retraction components with openings for a cranial/caudal rib retractor blade (lengths S and L), a caudomedial diaphragm blade (S, M and L) or a craniolateral lung blade (S, M and L).

Disposable components legend 13 Fixation clamp for caudomedial diaphragm blades in sizes S, M and L (BV173S-BV175S) 14 Retraction balloon for craniolateral lung blade in sizes S, M and L (BV184P-BV186P) 15 Pump with tubing system for retraction balloon (BV182P)

Symbols on product and packages Symbol

Explanation Sterilization using ethylene oxide Sterilization using irradiation Not for reuse in intended applications as defined by the manufacturer Use by

Caution, general warning symbol Caution, see documentation supplied with the product

Applicable to ► For item-specific instructions for use and information on material

compatibility, see also www.extranet.bbraun.com

2

the

Aesculap

Extranet

at

Available sizes Designation

Art.No.

Rib retractor blade in length S

BV162R

Rib retractor blade in length L

BV163R

Caudomedial diaphragm blade Length S

BV169R

Caudomedial diaphragm blade Length M

BV170R

Caudomedial diaphragm blade Length L

BV171R

Craniolateral lung blade Length S

BV164R

Craniolateral lung blade Length M

BV165R

Craniolateral lung blade Length L

BV166R

Fixation clamp for caudomedial diaphragm blade, size S

BV173S

Fixation clamp for caudomedial diaphragm blade, size M

BV174S

Fixation clamp for caudomedial diaphragm blade, size L

BV175S

Retraction balloon for craniolateral lung blade size S

BV184P

Retraction balloon for craniolateral lung blade size M

BV185P

Retraction balloon for craniolateral lung blade size L

BV186P

Safe handling and preparation

Safe operation

CAUTION Federal law restricts this device to sale by, or on order of a physician! Retraction system

WARNING

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

► Ensure that the product and its accessories are operated and used only

by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. Fixation clamp, retraction balloon, pump with tubing system

DANGER

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

WARNING

Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

Disassembling ► Prior to removing any retractor components, open the spigot of the

tubing system 15 and release the air from the retraction balloon.

Disassembly of the retraction system ► Carry out the assembly sequence as described above, only in reverse,

see Assembling.

Assembling Assembling the retractor components ► Mount the sliding piece 1 on the notched rod 2 with the aid of the

locking screw.

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

The product has been radiation/EO-sterilized and is supplied in sterile packaging. The product must not be reused. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

1

2

Fig. 1

Mounting the sliding piece

3

Aesculap® Miaspas miniTTA

► Push down on the ratchet lever 12 while sliding the adjustable piece 3

onto the notched rod 2.

► Push down on the ratchet lever 12 while sliding the adjustable piece 5

onto the notched rod 6.

12

12

2

3

5 Fig. 4 Fig. 2

6 Mounting the adjustable piece

► Push the handle 8 onto the diaphragm blade 7.

Mounting the adjustable piece

► Engage cranial and caudal retractor blades 4 of identical lengths in the

openings of the notched rod 2 and the adjustable piece 3.

2

3

8 4

4 Fig. 3

Mounting the rib retractors

7 Fig. 5

4

Mounting the handle

7

Injuries to organs and vessels! ► When inserting the diaphragm blade into the thorax, ensure that the tips of the fixation clamp do not protrude from the guide sheath of the blade.

DANGER

► Engage the diaphragm blade 7 in the attachment of the notched rod 6.

► Push the fixation clamp 13 through the guide on the diaphragm blade

7.

6

► Ensure that the fixation clamp 13 and diaphragm blade 7 are the same

length.

13 13

7

7

13

Fig. 7

Mounting the notched rod

► Push the neck of the balloon into the indentation at the distal end of

the lung blade 10. ► Insert the tube of the balloon 14 into the middle borehole in the lung

blade 10.

7

Fig. 6

Mounting the fixation clamp

For further information on the use of the fixation clamp in the spine, consult the relevant OP manual 0178. ► Insert into the thorax the caudomedial diaphragm blade 7 together with the interposed fixation clamp 13.

5

Aesculap® Miaspas miniTTA

► Push the neck of the balloon 14 onto the tube connector of the lung

► Place the sliding blade 9 on the lung blade 10.

blade 10.

9

10

14

10

14

Fig. 8

6

Fitting the retraction balloon

Fig. 9

Connecting the sliding blade to the lung blade

DANGER

Risk of death through damage to the retraction balloon and tubing system! ► Ensure that the assembled lung blade, retraction balloon and tubing system are correctly placed and fixed. ► Ensure that combinations of lung blades and retraction balloons are the same size.

► Fix the diaphragm blade 7 by tapping firmly on the fixation clamp 13. ► Mount the retractor 7 on the diaphragm blade. ► Remove the handle 8 from the diaphragm blade 7.

► Push the tubing system 15 onto the tube connector of the lung

blade 10.

15

10

7 Fig. 10 Attaching the tubing system

13

13

Mounting the retractor components ► Position the diaphragm blade 7 halfway between the two rib blades 4. ► Perform craniocaudal distraction of the ribs. ► Rotate the adjustment screw counterclockwise. ► Slide the notched rod 5 into the notched rod opening 2.

2

Fig. 12 Removing the handle ► Remove the locking screw on the sliding piece 1. ► Fit the sliding blade 9 with the completely assembled lung blade 10,

retraction balloon 14 and tubing system 15. ► Refix the locking screw on the sliding piece 1 at the desired retraction.

5 1

9 15

4 7

10 14

Fig. 11 Mounting the notched rod Fig. 13 Mounting the sliding piece

7

Aesculap® Miaspas miniTTA

► Operate the tubing system hand pump 15 until the desired lung retrac-

► At the opening of the sliding blade 9 and notched rod, push down with

tion is achieved. ► When performing lung retraction, close the spigot of the tubing system 15 by turning it to horizontal position. ► As necessary, uncouple the tubing system 15 with the pump. As necessary, reduce the internal pressure of the retraction balloon 14 using the spigot of the tubing system 15.

your thumb on the pushbutton, and with your index finger on the pressure plate 6. The diaphragm blade 7 and lung blade 10 can now be inclined.

Note A safety valve in the tubing system 15 prevents excessive pressure buildup in the retraction balloon 14.

6 9

10

7

Fig. 15 Inclining the diaphragm and lung blade

14

Validated reprocessing procedure General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

15 Fig. 14 Lung retraction

Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

8

Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Single-use products

WARNING

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

General information Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. 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. These must be removed by rinsing thoroughly with demineralized water and then drying.Additional drying, if necessary.

Only process chemicals that have been tested and approved (e.g. VAH 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 the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the

respective instructions for use. ► Open up products with hinges.

Preparations at the place of use ► If applicable, rinse non-visible surfaces preferably with deionized

water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

disinfection within 6 hours.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

9

Aesculap® Miaspas miniTTA

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleach-

ing/layer loss of the product.

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for (e.g. aluminum, plastics, high-grade steel), – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

► Use suitable cleaning/disinfecting agents if the product is put away in

a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Manual cleaning with immersion disinfection

Chapter Manual cleaning/disinfection and sub■ Suitable cleaning brush chapter: ■ 20 ml disposable syringe ■ Chapter Manual cleaning with immersion ■ Keep working ends open for cleaning. disinfection ■ When cleaning products with movable hinges, ensure that these are

■ BV162T ■ BV163T ■ BV169T - BV171

Reference

in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection

■ BV164T - BV166T ■ BV399R

Chapter Manual cleaning/disinfection and sub■ Suitable cleaning brush chapter: ■ 20 ml disposable syringe ■ Chapter Manual cleaning with ultrasound ■ Mount jaws protection on the product. and immersion disinfection ■ Keep working ends open for cleaning. ■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ BV162T ■ BV163T ■ BV413R

10

Chapter Mechanical cleaning/disinfecting and ■ Mount jaws protection on the product. sub-chapter: ■ Place the product in a tray that is suitable for cleaning (avoiding rins■ Chapter Mechanical alkaline cleaning and ing blind spots).

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning. ■ Place products in the tray with their hinges open.

thermal disinfecting

Validated procedure

Specific requirements

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

Chapter Mechanical cleaning/disinfection with ■ Suitable cleaning brush manual pre-cleaning and sub-chapter: ■ 20 ml disposable syringe ■ Chapter Manual pre-cleaning with a brush ■ Mount jaws protection on the product. ■ Chapter Mechanical alkaline cleaning and ■ Place the product in a tray that is suitable for cleaning (avoiding rinsthermal disinfecting

■ BV153R ■ BV169T - BV171 ■ BV399R

Reference

ing blind spots).

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning. ■ Place products in the tray with their hinges open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ BV154R ■ BV155R ■ BV164T - BV166T

Chapter Mechanical cleaning/disinfection with ■ Suitable cleaning brush manual pre-cleaning and sub-chapter: ■ 20 ml disposable syringe ■ Chapter Manual pre-cleaning with ultra■ Mount jaws protection on the product. sound and brush ■ Place the product in a tray that is suitable for cleaning (avoiding rins- ■ Chapter Mechanical alkaline cleaning and ing blind spots).

thermal disinfecting

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning. ■ Place products in the tray with their hinges open.

11

Aesculap® Miaspas miniTTA

Manual cleaning/disinfection Risk to patients! ► The product must only be cleaned mechanically!

► Prior to manual disinfecting, allow water to drip off for a sufficient

length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for

DANGER

residues. ► Repeat the cleaning /disinfection process if necessary.

Manual cleaning with immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15

min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until

all discernible residues have been removed from the surface.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time

using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.

► If applicable, brush through non-visible surfaces with an appropriate

Phase IV

cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.

► Rinse/flush the product thoroughly (all accessible surfaces).

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.

12

► Mobilize non-rigid components, such as set screws, joints, etc. during

final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure.

Manual cleaning with ultrasound and immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least five times at the beginning of the exposure time

with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during

final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure.

13

Aesculap® Miaspas miniTTA

Mechanical cleaning/disinfecting Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

14

Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

Neutral:

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline:

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing. ► Repeat the cleaning/disinfecting process if necessary.

15

Aesculap® Miaspas miniTTA

Mechanical cleaning/disinfection with manual precleaning Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15

min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until

all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate

cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during

cleaning. ► Thoroughly rinse through these components with the cleaning disin-

fectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing.

16

Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

► Mobilize non-rigid components, such as set screws, links, etc. during

syringes, see Validated cleaning and disinfection procedure.

cleaning. ► Thoroughly rinse through these components with the cleaning disin-

Phase I

fectant solution (at least five times), using a disposable syringe.

► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing.

Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

17

Aesculap® Miaspas miniTTA

Inspection, maintenance and checks

CAUTION

Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that

the product is dry, clean, operational, and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.

Packaging ► Store products with ratchet locks fully opened or locked no further

than in the first notch. ► Close the locks so that the jaw tips just touch each other. ► Place the product in its holder or on a suitable tray. Ensure that all cut-

Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. Note To avoid breakage due to stress crack corrosion, sterilize the product with the lock fully open or locked no further than on the first ratchet tooth. ► Check to ensure that the sterilizing agent will come into contact with

all external and internal surfaces (e.g. by opening any valves and faucets). ► 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 using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Sterilization for the US market

■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.

■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:

ting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in

Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against

recontamination of the product during storage.

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

Temp.

Time

Minimum drying time

Prevacuum

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 sterile container cleared by FDA for the sterilization and storage of these products. 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.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area. 18

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap

agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Disposal ► Adhere to national regulations when disposing of or recycling the

product, its components and its packaging!

Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

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