Heat-Stable Instruments Reprocessing Manual

Hygiene

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

[email protected] www.richard-wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05

[email protected] www.richard-wolf.com

[email protected] www.richard-wolf.com

Hygiene

Important general notes and instructions for use The reprocessing must be carried out with suitable, state-of-the-art procedures by qualified medical personnel follow­ ing the manufacturer's notes and instructions. Reprocessing must be traceable and reproducible. A classification and risk assessment must be carried out. The individual steps and responsibilities must be listed and documented in writ­ ing. Requirements for reprocessing: Basic requirements are defined in ' The Medical Product Law (MPG) ' The Medical Product Operator Directive (MedBetreibV) ' The Agreements on Quality Assurance (QA) ' The European Standards (DIN EN) ' The appropriate Recommendations on Hospital Hygiene issued by the Robert Koch Institute and ' The current rules and regulations issued by the Employers’ Liability Insurance Associations.

The product must only be used as intended following the instruction manual by adequately trained and qualified medi­ cal personnel. Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbol

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

. .

GA- J020

IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE !

User tips for optimum device use and other useful information.

0

Contents Hygiene

1

General Information...

1

1.1

Manuals / Instructions for use...

1

1.2

Material compatibility / proof of efficacy...

1

1.3

Chemicals for reprocessing...

1

1.4

Questions concerning RICHARD WOLF products...

2

1.5

Basic notes and instructions...

2

1.6

Brand new products...

2

1.7

Disposable item...

3

1.8

Characteristic features of steam sterilizability...

4

1.9

Instrument reprocessing...

5

1.10

Overview of reprocessing / material compatibility...

6

2

Illustration...

8

3

Water quality... 10

3.1

Ion exchanger for full demineralization... 10

4

Preparation of the instruments at the point of use... 11

4.1

Small-diameter instruments... 11

4.2

HF instruments / electrodes... 12

4.3

Reprocessable tube and hose systems... 12

4.4

Transport... 12

5

Machine cleaning and disinfection... 13

5.1

Thermal method... 14

5.2

Determination of the A0 value... 15

5.3

Preparatory measures for machine reprocessing... 16

5.4

Auxiliary resources required... 17

5.5

Disassembly before cleaning... 18

1.7.1 1.7.2 1.8.1 1.8.2

4.4.1 4.4.2 4.4.3

5.1.1 5.1.2

5.3.1

I

Unsterile disposable items... Sterile disposable items... Telescopes and instruments... Objective lenses and camera heads...

Dry preparation at the point of use... Wet preparation at the point of use... Storage systems...

Machine - alkaline... Machine - ph-neutral / enzymatic...

Manual pre-cleaning... 5.3.1.1 Camera cable / camera plug... 5.3.1.2 Instrument connectors... 5.3.1.3 Instruments with hollow spaces / channels... 5.3.1.4 Instruments with movable parts - articulated instruments...

3 3

4 4

12 12 12

14 15

16 16 16 17 17

GA-J020

Contents Hygiene

5.6

Correct loading of washer-disinfector... 21

5.6.1 5.6.2 5.6.3 5.6.4 5.6.5 5.6.6

Telescopes... Camera heads... Instruments with hollow spaces / channels... Instruments with movable parts - articulated instruments... Instruments with stopcocks... Accessories... 5.6.6.1 Mechanical... 5.6.6.2 Optical... 5.6.6.3 Electrical...

5.7

After machine reprocessing... 27

5.8

21 22 23 25 26 26 26 27 27

Storage systems... 27

5.8.1 5.8.2

RIWO SYSTEM TRAY... Reprocessing baskets...

6

Manual cleaning and disinfection... 28

6.1

Auxiliary resources required... 28

6.2

Cleaning... 29

6.2.1 6.2.2

6.2.3 6.2.4

6.3

6.3.1 6.3.2

6.4

6.4.1 6.4.2 6.4.3

Telescopes... 6.2.1.1 Telescopes without working channel... 6.2.1.2 Telescopes with working channel... Working instruments... 6.2.2.1 Articulated instruments with irrigation connector... 6.2.2.2 Suction and irrigation instruments... 6.2.2.3 Resectoscopes... 6.2.2.4 HF instruments / electrodes... Access instruments... 6.2.3.1 Instruments with hollow spaces / channels... Accessories... 6.2.4.1 Mechanical... 6.2.4.2 Optical... 6.2.4.3 Electrical...

27 27

30 30 31 32 32 32 32 33 33 34 34 34 35 36

Ultrasonic cleaning... 37

Cleaning in the ultrasonic bath... After ultrasonic cleaning...

37 37

Disinfection... 38

6.4.4

RIWO BOX SYSTEM... After disinfection... Accessories... 6.4.3.1 Mechanical... 6.4.3.2 Optical... 6.4.3.3 Electrical... Reprocessing material...

7

Checks and maintenance... 40

7.1

Visual check... 40

7.1.1 7.1.2 7.1.3 7.1.4

GA-J020

Telescopes / optical accessories... Working instruments... Access instruments... Accessories... 7.1.4.1 Mechanical... 7.1.4.2 Optical... 7.1.4.3 Electrical...

38 38 38 38 39 39 39

40 41 42 43 43 43 44

II

Contents Hygiene

7.2

Function check... 44

7.3

Notes and instructions on maintenance before sterilization... 45

8

Sterilization... 47

8.1

Auxiliary resources required... 47

7.3.1 7.3.2

8.2

8.2.1

45 46

Steam sterilization... 48

8.2.3

Overview of steam sterilization procedures... 8.2.1.1 Fractional pre-vacuum procedure... 8.2.1.2 Other steam sterilization procedures... Accessories - information on special products... 8.2.2.1 Optical... Assembly after sterilization...

8.3

Low-temperature sterilization... 51

8.2.2

8.3.1 8.3.2

8.3.3

8.4

Hydrogen peroxide plasma... 8.3.1.1 STERRAD 50 / 100S / 200 / NXt and 100 NXt... 8.3.1.2 Sterilizers with Booster / diffusion amplifier in STERRAD® 50 / 100S / 200... Gas... 8.3.2.1 Ethylene oxide gas (EO)... 8.3.2.2 Low temperature steam and formaldehyde (LTSF)... 8.3.2.3 Hydrogen peroxide (V-PRO™1)... Peracetic acid / High Level Disinfection... 8.3.3.1 STERIS SYSTEM 1 / STERIS SYSTEM 1E™...

48 48 49 50 50 50

51 51 52 53 53 53 53 54 54

Storage systems for sterilization... 54

8.4.1 8.4.2 8.4.3

RIWO SYSTEM TRAY... Reprocessing baskets... Sterilization sieve basket system...

8.5

Sterilization of cleaning accessories... 55

9

Storage... 56

9.1

After disinfection... 56

9.2

After sterilization... 56

10

Repairs, returned products... 56

11

Accessories for reprocessing... 57

12

Product information on cleaning and care products... 63

12.1

Instrument oil 200.532... 63

12.2

Instrument Grease 20012... 65

13

Literature... 66

14

Index... 70

12.1.1 12.1.2 12.1.3 12.1.4 12.2.1 12.2.2 12.2.3

III

Working instruments... Access instruments...

Product description... Field of use... Additional notes and instructions for use... Product specifications... Product description... Field of use... Additional notes and instructions for use...

54 54 55

63 63 63 63 65 65 65

GA-J020

General Information Hygiene

1

General Information

1.1

Manuals / Instructions for use

For safe use and correct reprocessing of RICHARD WOLF products and accessories, RICHARD WOLF provides the following manuals / instructions for use: Z GA-J020 Manual on “Reprocessing of RICHARD WOLF Heat-Stable Instruments” Z GA-J050 Manual on “Reprocessing of RICHARD WOLF Heat-Sensitive Instruments” Z Product-specific Instructions for Use They describe the specific use of the product with all the specifications re­ quired. Z Latest version of the Manual / Instructions for Use Ongoing new and further development of RICHARD WOLF products as well as technological progress require updating of the instruction manual at regular intervals. Please check the number of the latest version by checking the last numbers of the index on the front page. Example: GA-J020 / en / 2014-05 V17.0 /... You may call up the latest version from our website and download it, or request the document from us. www.richard-wolf.com

.

NOTE! In addition to these manuals / instructions for use we recommend the following brochure, published by the "AKI" working group (Arbeitskreis Instrumentenaufbere­ itung).

Instrument reprocessing

Reprocessing instruments maintaining their value

The brochure is available from RICHARD WOLF or can be downloaded free of charge from the webpage www.a-k-i.org.

1.2

Material compatibility / proof of efficacy RICHARD WOLF has tested the low temperature sterilization procedures described in section 1.10 "Overview of reprocessing / material compatibility" regarding their material compatibility. The effectiveness of steam sterilization using the fractional pre-vacuum method in accordance with DIN EN 285 / ISO 14937 has been proven.

1.3

Chemicals for reprocessing The chemicals for the reprocessing of heat-stable and heat-sensitive instruments [rigid telescopes, flexible endoscopes / videoscopes (fiberscopes) and instruments] approved by RICHARD WOLF with regard to their material compatibility are listed and can be downloaded from our website. www.richard-wolf.com/reprocessing-chemicals This overview is updated at regular intervals.

GA- J020

1

General Information Hygiene

1.4

Questions concerning RICHARD WOLF products

If you have questions concerning RICHARD WOLF products or their reprocessing, please contact our customer service department.

RICHARD WOLF SERVICE www.richard-wolf.com/customer-service

1.5

Basic notes and instructions WARNING! Creutzfeldt-Jakob Disease ! If the patient is suspected of having the Creutzfeldt- Jakob disease (CJD) or a vari­ ant of the Creutzfeldt- Jakob disease (vCJD) or the latter has been diagnosed, ade­ quate measures must be taken to prevent possible transmission to other patients, users and third parties. For this purpose, apply the country-specific reprocessing guidelines and regulations.

1.6

.

IMPORTANT! Rental instruments must not be used in pathology or veterinary medicine.

.

IMPORTANT! During the entire reprocessing phase, be sure to follow the guidelines on the pro­ tection of the workplace and on the protection of the staff, e.g. TRBA 250.

.

IMPORTANT! Do not use physiological saline for immersion or rinsing as this can cause corrosion of metal surfaces. Avoid frequent changes of reprocessing methods as well as cleaning agents and disinfectants as interactions between the latter can cause damage to the product. Preclean the instruments immediately after use at the point of use and reprocess as soon as possible. ' See section 4 “Preparation of instruments at the point of use”

Brand new products

.

2

NOTE! Before reprocessing remove all protection foils and shipping locks or clips from the products and the accessories. Reprocess the products and the accessories at least once before the first use. For the permissible procedures please refer to the following sections and/or the productspecific manuals.

GA- J020

General Information Hygiene

1.7

Disposable item

1.7.1

Unsterile disposable items

Disposable items must be ' used only once ' discarded after use

Reprocess unsterile disposable items before use. ' See product-specific instructions for use

WARNING! Multiple use of disposable items! The service life of products marked as disposable, i.e. for one single use only, has been designed for only one use in or on a single patient. Multiple uses can impair and or change the product properties and therefore endan­ ger the patient, user and others. Possible dangers / risk factors are described in the product-specific instruction manuals and must be observed. In the case of multiple uses, the product responsibility lies with the user. In this case the manufacturer can no longer guarantee the safety and perfor­ mance of the product. 1.7.2

Sterile disposable items

WARNING! Do not reprocess disposable items! The service life of products marked as disposable, i.e. for single use only, is de­ signed for only one use in or on a single patient. If disposable items are reprocessed to be used again, a deterioration of the prod­ uct quality cannot be excluded, which will endanger the patient, the user and oth­ ers. Possible dangers / risk factors are described in the product-specific instruction manuals and must be observed. If a disposable item is reprocessed, the product responsibility lies with the user or reprocessor. In this case, the manufacturer can no longer guarantee product safety and perfor­ mance.

.

GA- J020

IMPORTANT! The sterility of sterile products is only guaranteed if the packaging hasn't been damaged or opened. ' Do not use the product if the sterile packaging is damaged or the use-by date has expired.

3

General Information Hygiene

1.8

Characteristic features of steam sterilizability

1.8.1

Telescopes and instruments

1.8.2

Objective lenses and camera heads

The product number of RICHARD WOLF products indicates steam-sterilizability.

Z Steam sterilizable ' Identification feature: the product numbers begin with “8”. Example: 8654.433 Z Not steam sterilizable ' Identification feature: the product numbers begin with “4”. Example: 4654.433

Z Steam sterilizable ' Identification feature: the product numbers begin with “8”. Example: 85261.212 Z Not steam sterilizable ' Identification feature: the product numbers begin with “5”. Example: 5268.221

.

4

IMPORTANT! For the reprocessing and/or sterilizability of products with product numbers not starting with “8”, please refer to the product-specific manuals. Follow these manu­ als.

GA- J020

General Information Hygiene

1.9

Instrument reprocessing

The products and accessories can be reprocessed manually or machine-repro­ cessed in a washer/disinfector. For validation reasons, machine reprocessing is preferred. The following overview is a schematic of the sequence of reprocessing steps for heatstable instruments. The sections mentioned refer to the corresponding methods and procedures.

A

Preparations after use e.g. in the OR

Section 4

Visual check

Section 7.1

Transport

to the reprocessing department Section 4.4

Undamaged ?

if possible

Cleaning gun / Ultrasound

MACHINE

Repair / scrap

yes

pre-cleaning

Section 6 Section 6.2

No

Productspecific manual

MANUAL

Section 10

Assembly, maintenance, care

Section 7.2

Function check

Section 10

Repair / scrap No

Cleaning Disinfection Rinsing Drying

Cleaning gun / brush / ultrasound

(validated processes/ verified parameters)

Irrigation

Section 5

Cleaning

yes

o.k.?

No

Section 6

Section 6.3

yes

Sterilized

Disinfected

for use

for use

Packaging

Cleaning o.k.?

Cleaning o.k.?

yes

Disinfection Irrigation

Section 6.4.1 Section 6.4.2

with fully desalinated water / Aquatest if possible, sterile water

Drying

A

GA- J020

Section 8.1 Section 8.2 Section 6.4

Identification

Disinfection

if possible

Rinsing

yes

Section 6.4

No

Section 6.4.1

Approval for sterilization

with sterile water

Section 8 if possible

Sterilization

Packaging

Documentation

Documentation

Section 9

Section 9

Storage

Storage

Provision

Provision

5

General Information Hygiene

Overview of reprocessing / material compatibility PRODUCTS

Telescopes

Working instruments

Flexible

Disposable, Sterile

Disposable, Unsterile

D D D

D D D

D D D

Y

Y

Y

Y

d

D

D D D

8x 4x

PROCEDURES Preparation at the point of use

Rigid

05)

Wet preparation at the point of use

Access instruments

1.10

Preparation

Pre-clean manually if necessary

D D D

Cleaning

Manual

D

D

D

D

d

D

D

Machine

60

Thermal max. 93_C

D d D D D D D D D

d D D D D D D d

D D D D D D D D D

D D D D D D D D D

100

60

100

100

H d H H D03) d D D d H

D D D D D D D D D

Tmax in C

d d d d d d d d d d

100

After decontamination

H

H

H

H

d

H

H

d

D

D

d

H

D

Ethylene oxide (EO)

D D D

D D D

D D D

D D D

d d d

H H H

D D D

Low temperature steam and formaldehyde (LTSF)

D

D

D

D

d

H

D

Hydrogen peroxide (STERIS V-PRO 1, V-PRO 1 Plus, V-PRO maX)

D

D

D

D

d

H

D

D

D

D

D

d

d

D

Condition

Dry preparation at the point of use

Ultrasound Alkaline Containing citric acid

Decontamination

Neutral / enzymatic Containing peracetic acid Rinsing 01) Disinfecting 02) Drying

Maintenance, checks

Chemical max. 60_C

Steam sterilization 03) Steam

Fractional pre-vacuum method 134°C / 273°F 132°C / 270°F

D

Low-temperature sterilization

Sterilization

Hydrogen perox­ ide plasma

Gas

Peracetic acid 04) (Just in time) x) 01) 02) 03) 04) 05)

STERRAD50, 100S, 200 STERRADNX™, 100NX™

STERIS SYSTEM 1

STERIS SYSTEM 1E™

Starting with product number “8...” / “4...”

Fully demineralized water recommended for the last rinsing cycle Chemicals for reprocessing (see section 1.3) Preferred procedure to be used Products are not packed sterile (see section 8.3.3) Before use

6

Legend:

D Permissible d Not permissible / not necessary Y Discard disposable item

H See product-specific instructions for use

GA- J020

General Information Hygiene

Accessories

PRODUCTS

Mechanical

Disposable, Sterile

Disposable, Unsterile

Fiber light cables

Fluid light cables

Camera cables

Lenses Camera heads

D

Y

Y

D

D

D

D

D

D

D

Dry preparation at the point of use

D

D

Y

Y

D

D

D

D

D

D

D

D D D d D D D D D D D

D D H d H H D03) d D D d

D D D d D D D D D D D

D D D d D D D D D D D

D D D d D D D D D D D

D D D d D D D D D D d

D D D d D D D D D D D

D D D d D D D D D D D

100 100

D D d d d d D d D d d d

100 100

60

100 100

H

H

H

H

H

H

H

H

D

d

D

D

d

D

D

Preparation

Pre-clean manually if necessary

Cleaning

Manual

Disinfecting 02)

Chemical max. 60_C Thermal max. 93_C

d D D d d d D d D D D

Drying

Tmax in C

100 100

d d d d d d d d d d d d

After decontamination

D

d

Machine Ultrasound Alkaline Containing citric acid

Decontamination

Neutral / enzymatic Containing peracetic acid Rinsing 01)

Maintenance, checks

H

Electrical

Reprocessable

d

05)

Adapters

Rubber bulb 103.00 Double bulb 127.00

Condition

8x) 5x)

Wet preparation at the point of use

PROCEDURES Preparation at the point of use

Optical

Steam sterilization 03) Steam

Fractional pre-vacuum method 134_C / 273_F 132°C / 270°F

d

D

d

H

Low-temperature sterilization Hydrogen peroxide plasma Sterilization Gas

STERRAD50, 100S, 200

Ethylene oxide (EO) 

d d d

D D D

d d d

H H H

D D D

D D d

D D D

D D D

H H D

D D D

D D D

Low temperature steam and formaldehyde (LTSF)

d

D

d

H

D

d

D

D

D

D

D

d

D

d

H

D

d

D

D

H

D

D

d

D

d

d

D

d

D

D

D

D

D

STERRADNX™, 100NX™

Hydrogen peroxide

(STERIS V-PRO 1, V-PRO 1 Plus, V-PRO maX)

Peracetic acid 04)

(Just in time) x) 01) 02) 03) 04) 05)

STERIS SYSTEM 1 STERIS SYSTEM 1E™

Starting with product number “8...” / “5...”

Fully demineralized water recommended for the last rinsing cycle Chemicals for reprocessing (see section 1.3) Preferred procedure to be used Products are not packed sterile (see section 8.3.3)

Before use

GA- J020

Legend:

D Permissible d Not permissible / not permissible Y Discard disposable item

H See product-specific instructions for use

7

RICHARD WOLF products Hygiene

2

Illustration The following illustrations contain a selection of the wide range of RICHARD WOLF heat-stable instruments. Important notes on the reprocessing of these heat-stable instruments are de­ scribed in the following sections and serve as an example.

TELESCOPES Rigid telescopes

CCD telescopes

Operating or compact telescopes

WORKING INSTRUMENTS Forceps, scissors, punches

Blunt, cutting

Suction, irrigation

Electrodes

Working inserts

Working elements

Fig. 1

8

GA-J020

RICHARD WOLF products Hygiene

ACCESS INSTRUMENTS Trocars

Trocar sleeves, Cannulas

Sheaths

Obturators

ACCESSORIES Mechanical

Optical

Electrical

Fig. 2

GA-J020

9

Reprocessing water Hygiene

3

Water quality

The water quality used for product reprocessing has a great influence on the preservation of value. Depending on the water hardness and temperature, differing drinking water quali­ ties (types and concentrations of ingredients) can cause difficult-to-dissolve hard­ ness deposits, corrosion and discoloration on the products. The concentration of the water ingredients varies depending on the source and type of drinking water treatment. When water evaporates these ingredients remain in the form of a salt crust. Amongst these ingredients chlorides are particularly critical.

.

3.1

IMPORTANT! Excessive chloride concentrations cause pitting corrosion on stainless steel! To avoid this when machine-cleaning products, we recommend using fully dem­ ineralized water of a defined water quality in accordance with DIN EN 285, Appen­ dix B for the final rinsing.

Ion exchanger for full demineralization

When using ion exchangers for full demineralization please note that exceeding the regeneration cycle can cause silicic acid (silica) to break through, which will cause deposits. Timely regeneration of the exchanger can avoid this. For this purpose please fol­ low the manufacturer’s instructions. Source:

Instrument reprocessing

Reprocessing instruments maintaining their value www.a-k-i.org

.

NOTE! Fully demineralized water with the following microbiological drinking water quality should be used for final rinsing: ' The total bacteria count must not exceed the value of 100 CFU *) / ml during an incubation period of 44 4 hours at 36 1C. ' Escherichia coli must not be present in 100 ml. ' Pseudomonas aeruginosa must not be present in 100 ml. *) colony-forming units

Source:

Directive on the quality of water intended for human consumption (German Drinking Water Ordinance - TrinkwV 2001) www.gesetze-im-internet.de/trinkwv_2001/anlage_3_35 bzw. anlage_5_377

The national guidelines of the Drinking Water Ordinance must be followed.

10

GA-J020

Preparation of instruments Hygiene

4

Preparation of the instruments at the point of use CAUTION! Danger of microbial carry-over! To prevent a contamination of the camera plug when disconnecting the latter from the camera controller during the course of the operation, screw on / plug on the protection cap immediately after disconnection. A contaminated camera plug must be reprocessed manually before installing the protection cap. Z Immerse the camera plug in a certified compatible cleaning and disinfectant solu­ tion. Z Then rinse with sterile water. Z Dry the outer surfaces with a lint-free disposable cloth, dry the contacts inside with a cotton swab. ' Residual moisture in the contacts can impair signal transmission (e.g. interrup­ tions, poor contacts).

.

NOTE! Drying of contaminant residues (blood, tissue particles, drugs, etc.) makes repro­ cessing difficult and increases the danger of corrosion. The measures listed in the following must be carried out during use at the instru­ ment table or immediately after: Z Wipe the outside of the instruments with a lint-free disposable cloth to remove any coarse contamination / soiling. ' Under no circumstances should the instruments be immersed in saline (NaCl solution)(pitting corrosion). Z Disassemble the instrument if necessary. ' See product specific-instructions for use. ' See section 5.5 “Disassembly before cleaning". Z Discard disposable items immediately, e.g. ' Hygiene filter ' Sealing membrane (membrane valve) ' Disposable tube / tube set Z Lay down the instruments with due care to avoid damage. Z Open the stopcocks.

4.1

Small-diameter instruments Fig. 3 Z Rinse out small-diameter instruments with sterile irrigation solution. ' When rinsing out the channels make sure you do not splash irrigation solu­ tion into the environment.

Fig. 3

GA-J020

11

Preparation of instruments Hygiene

4.2

HF instruments / electrodes Encrusted coagulation surfaces impair the HF power. Fig. 4 Z Dissolve encrustations with 3% hydrogen peroxide solution (H2O2 solution) and wipe off with a compress. Z If necessary, the coagulation surfaces can be wiped at intervals during the op­ eration using a compress. Z Then rinse with sterile water.

Fig. 4 4.3

Reprocessable tube and hose systems Disassemble and rinse out reprocessable (reusable) hose / tube systems.

4.4

Transport The parts can be transported to the reprocessing rooms either under wet or in dry conditions, depending on the reprocessing method used.

4.4.1

Dry preparation at the point of use In the case of machine reprocessing, dry preparation at the point of use is the method of choice, because residues from the solution for wet decontamination at the point of use can impair the cleaning result in the WD (Washer Disinfector). Z Carry out preparatory measures at the point of use: see section 4

4.4.2

Wet preparation at the point of use In the case of manual reprocessing, wet preparation at the point of use is recom­ mended in order to avoid residues from drying on the instruments and prevent micro­ bial carry-over. For wet decontamination use a certified combined cleaning and disinfectant solu­ tion with proven disinfection efficacy. For this purpose use the certified (approved) compatible agents as used for sub­ sequent cleaning and disinfection.

4.4.3

Storage systems For a safe and trouble-free transport to the reprocessing room, we recommend using the specialized transport and storage systems. For further information please see: ' Section 11 ' RICHARD WOLF catalog pages

12

“Accessories for reprocessing". “Hygiene - Reprocessing".

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Machine reprocessing Hygiene

5

Machine cleaning and disinfection

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IMPORTANT! We recommend that you avoid using Cleaning and disinfectant solutions in powder form, because undissolved particles can clog narrow channels and discolor the in­ struments. When using powder-based solutions, make sure that all the powder has dissolved. Use only disinfectants whose efficacy and compatibility with rigid telescopes and endoscopic accessories has been verified and approved. ' See section1.3 “Chemicals for reprocessing“ For the concentration and exposure time of the cleaning and disinfectant agent used, please refer to the specifications issued by the manufacturer of the chem­ icals. Do not use any care products for the last rinsing, as these can cause deposits on the products and damage to the plastic materials.

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IMPORTANT! Use only WD devices (Washer Disinfector Device), that ' are designed by the manufacturer for rigid telescopes and endoscopic acces­ sories. ' are equipped with a special load carrier, allowing the connection of rigid instru­ ments and endoscopic accessories to the WD device and the rinsing of chan­ nels. The certified cleaning agents and disinfectants must be compatible with each other, with the procedure as well as with the rigid telescope and endoscopic accessories. In accordance with DIN EN ISO 15883 the user must validate the machine reprocess­ ing procedures used. Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF prod­ ucts.

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IMPORTANT! In the case of instruments which due to hard-to-remove contaminants need to be cleaned manually or pre-cleaned in an ultrasonic bath, follow the corresponding sec­ tions of this manual. ' Section 5.3.1 “Manual pre-cleaning". ' Section 6.3 “Ultrasound cleaning".

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NOTE! All steam sterilizable heat-stable instruments can be machine reprocessed unless their specific instruction manual requires otherwise. For the machine reprocessing of small parts, use a small parts sieve or utensils basket, respectively, made by the washer-disinfector manufacturer.

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Machine reprocessing Hygiene

5.1

Thermal method For the machine reprocessing of heat-stable instruments we recommend a ther­ mal method using ' an alkaline cleaner and neutralizer or ' a neutral or enzymatic cleaner, respectively. ' a procedure which has been optimized for telescopes avoiding temperature­ leaps. Thermal procedures disinfect purely thermally, without the addition of disinfectant. For the above, note and observe the following: ' Follow the country specific guidelines as well as ' The standard DIN EN ISO 15883. The following processes have been proven successful and have been validated by RICHARD WOLF:

5.1.1

Machine - alkaline Fig. 5

30 20

Fig. 5

Drying

40

Disinfection

50

Cleaning

60

Pre- rinse

55

Neutralization

90 80 70

C

Intermediate rinse

T 100

t

Program (without disinfection step) - alkaline Z >4 min of precleaning with cold water Z empty Z >6 min of cleaning with a cleaning agent at approx. 55C Z empty Z >3 min of neutralization*) (<40C) Z empty Z >2 min of intermediate rinsing (<40C) Z empty *) Depending on the water quality, add a neutralization solution based on citric acid.

Disinfection Z Carry out thermal machine disinfection following the national requirements with regard to the A0 value (see DIN EN ISO 15883).

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14

IMPORTANT! Do not use any drying aids (such as rinse aids) for the last rinsing cycle (disinfec­ tion). These may remain on the surface causing damage to the instrument due to unfavorable interference.

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