Heat-Sensitive 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 on 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-J 050

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 / Efficacy test...

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

1.7.1 1.7.2

Unsterile disposable items... Sterile disposable items...

3 3

1.8

Characteristic features of steam sterilizability...

3

1.9

Instrument reprocessing...

4

1.10

Overview of reprocessing / material compatibility...

5

2

Product variants...

6

2.1

Illustration...

7

3

Water quality...

8

3.1

Ion exchanger for full demineralization...

8

4

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

9

4.1

Transport... 10

4.2

Preparatory measures for machine and manual reprocessing... 10

5

Machine reprocessing... 11

5.1

Auxiliary resources required... 11

2.1.1

4.1.1 4.1.2 4.1.3

5.2

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

7

10 10 10

Heat-sensitive instruments... 12

5.2.1 5.2.2

Chemo-thermal procedure... Chemical procedure...

5.3

Connect flexible endoscope to washer-disinfector unit... 12

5.4

Connection for automatic leakage tester... 16

5.5

After machine reprocessing... 16

5.6

Storage systems... 16

5.3.1 5.3.1.1 5.3.2 5.3.2.1 5.3.3 5.3.3.1 5.3.3.2 5.3.3.3 5.3.3.4

I

Legend and identification...

Rinsing set II (163.907)... Connection to bronchoscopes... Rinsing set III (163.908)... Connection to video bronchoscopes... Rinsing set V (163910)... Connection to video urethro-cystoscopes... Connection to fiber ureterorenoscope / BOA Vision Flexible Sensor URS... Connection to 2-channel continuous-irrigation laser URS / COBRA Vision Flexible Sensor URS Connection to adapter (4)...

12 12

13 13 13 13 14 14 15 15 15

GA-J 050

Contents Hygiene

6

Manual reprocessing... 17

6.1

Manual cleaning and disinfection... 17

6.2

Auxiliary resources required... 17

6.3

Manual leakage test... 18

6.4

Manual cleaning... 19

6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.6.1 6.4.6.2

6.5

Install adapter (163914) (only for 2-channel continuous irrigation laser URS)... Working channel (1) / suction channel (7) / laser fiber channel (13)... Selecting the cleaning brushes... Biopsy valve (5) / suction valve (8) / laser adjustment unit, complete (15)... Stopcocks (4.2)... Working channel (1) / suction channel (7) / laser fiber channel (13)... Disposable cleaning brushes... Reprocessable cleaning brushes...

19 20 21 21 22 22 23 24

Manual disinfection... 26

6.5.1

After disinfection...

6.6

Storage systems... 27

7

Checks and maintenance... 28

7.1

Visual check... 28

7.2

Function check... 28

8

Sterilization... 30

8.1

27

Auxiliary resources required... 30

8.1.1

Sterisafe® DURO A3 Set for fiberscopes H2O2...

8.2

Low-temperature sterilization... 32

8.2.1 8.2.2 8.2.2.1 8.2.3 8.2.4 8.2.4.1 8.2.4.2 8.2.4.3 8.2.5 8.2.5.1

8.3

Install pressure equalization valve (A) or LTSF valve (B)... Hydrogen peroxide plasma... STERRAD 50 / 100S / 200 / NXt and 100 NXt... Sterilization using a booster / diffusion amplifier in STERRAD® 50 / 100S / 200... Gas... Ethylene oxide gas (EO)... Low-temperature steam and formaldehyde (LTSF)... Hydrogen peroxide (V-PRO™1)... Peracetic acid... STERIS SYSTEM 1 / STERIS SYSTEM 1E™...

31

33 34 34 34 35 35 36 36 36 36

Sterilization of storage systems and cleaning accessories... 37

8.3.1 8.3.2

RIWO System Tray and Sterisafe® DURO A3 Set... Cleaning brushes and cleaning wire...

9

Storage... 38

9.1

After disinfection... 38

9.2

After sterilization... 38

10

Repairs, returned products... 38

11

Accessories for reprocessing... 39

12

Literature... 46

13

Index... 50

GA-J 050

37 37

II

General Information Hygiene

1

General Information

1.1

Manuals / Instructions for use

RICHARD WOLF provides the following different manuals / instructions for safe use and correct reprocessing of RICHARD WOLF products and accessories: Z GA-J020 Manual “Reprocessing of RICHARD WOLF Heat-Stable Instruments" Z GA-J050 Manual “Reprocessing of RICHARD WOLF Heat-Sensitive Instruments” Z Product-specific instructions for use These instructions describe the specific use of the product with all the neces­ sary data and information. Z The current version of the manuals / instructions for use Continuous new and further developments of RICHARD WOLF products and technological advances mean that the manuals / instructions for use have to be updated 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-J050 / en / 2014-05 V7.0 /... 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 Instrumentenaufbe­ reitung).

Instrument reprocessing

Reprocessing instruments maintaining their value

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

1.2

Material compatibility / Efficacy test RICHARD WOLF has tested the low-temperature sterilization procedures described in section 1.10 "Overview of reprocessing / material compatibility", with regard to 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.

1

GA- J 050

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.

.

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 protection of the workplace and on the protection of the staff, e.g. TRBA 250.

.

IMPORTANT! Do not use physiological saline solution for immersion or rinsing as this can cause corrosion of metal surfaces. Avoid frequent changes of reprocessing methods as well as cleaning agents and dis­ infectants 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”

1.6

Brand new products

.

GA- J 050

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. The certified procedures are described in the following sections or in the productspecific instructions for use.

2

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 endanger the patient, user and others. Possible dangers / risk factors are described in the product-specific instruction ma­ nuals 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 per­ formance 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 designed for only one use in or on a single patient. If disposable items are reprocessed to be used again, a deterioration of the product quality cannot be excluded, which will endanger the patient, the user and others. Possible dangers / risk factors are described in the product-specific instruction ma­ nuals 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 per­ formance.

.

1.8

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.

Characteristic features of steam sterilizability

The steam sterilizability of RICHARD WOLF products can be identified, e.g. from the product number: Z Steam sterilizable ' Identification feature: the product numbers begin with “8” Example: 8654.422 Z Not steam-sterilizable ' Identification feature: the product numbers begin with “4” Example: 4840.501

.

3

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 manuals.

GA- J 050

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 heat- sensitive instruments - in the following descriptions called "Flexible Endoscopes". The sections mentioned refer to the corresponding methods and pro­ cedures.

A

Preparations after use e.g. in the OR

Section 4

Visual check

Section 7.1

Transport

to the reprocessing department Section 4.1

Undamaged ?

if possible

Cleaning gun

Section 6.1

MACHINE

Repair / scrap

yes

pre-cleaning

Section 6

No

Productspecific manual

MANUAL

Section 10

Assembly, mainte­ nance, care

Section 7.2

Function check

Section 10

Repair / scrap Cleaning Disinfection Rinsing Drying

Cleaning gun / Brush

(validated processes/ verified parameters)

Rinsing

No

Section 5

Cleaning

ye s

No

o.k.?

Section 6

Section 6.4

yes

Sterilized

Disinfected

for use

for use

Packaging

Cleaning o.k.?

Cleaning o.k.?

yes

Disinfection Rinsing

with fully desalinated water / Aquatest Section 6.5.1 Section 6.5.2

if possible, sterile water

Drying

A GA- J 050

Section 8.1 Section 8.2 Section 6.5

Identification

Disinfection

if possible

Rinsing

yes

Section 6.5

No

Section 6.5.1

Approval for sterilization

with sterile water

Section 8 if possible

Sterilization

Packaging

Documentation

Documentation

Section 9

Section 9

Storage

Storage

Provision

Provision

4

General Information Hygiene

1.10

Overview of reprocessing / material compatibility PRODUCTS

Rubber bulb 103.00 Double bulb 127.00

Valves

Seals, unsterile

Adapter (stopcock plug)

Laser adjustment unit

Tube fitting, Twist-lock

Reprocessable

Single use

Cleaning

Manual

Disposable, Unsterile

Leakage test

Disposable, Sterile

Preparation

Stone extractor Stone grasper

Dry preparation at the point of use

Flexible coagulation button electrode

Condition

D

D

D

D

d

d

d

D

D

D

D

d

d

d

D

D

D

D

Y

Y

d

D

D

D

D

D

D

Y

D

D

D

D

Y

Y

D

D

D

D

D

D

D

Y

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 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

H

100

100

100

100

100

100

100

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

H

D

H

H H H

H

H d

H

d

D

D

D

D

D

D

d

05)

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

60

100

100

100

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

After decontamination

H

H

H

H

d

Machine Ultrasound 03) Alkaline Containing citric acid

Decontamination

Neutral / enzymatic Containing peracetic acid Rinsing 01)

Maintenance, checks

Cleaning brushes

Flexible forceps

Preparation at the point of use

Wipe outside, rinse out inside Wet preparation at the point of use

Leakage tester

Flexible endoscopes

PROCEDURES

Suction / Biopsy connector / Laser adjustment unit

Accessories 03)

H d

H H H03)

Steam sterilization 03) Steam

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

d

D

D

D

d

Low-temperature sterilization Hydrogen per­ oxide plasma Sterilization

Gas

STERRAD 50, 100S, 200 STERRAD NXt,100NXt

D D

D D

D D

D D

d d

H H

d d

D D

D D

D D

D D

D D

D D

d d

Low-temperature steam and formaldehyde (LTSF)

D

D

D

D

d

H

d

D

D

D

D

D

D

d

Ethylene oxide (EO)

D

D

D

D

d

H

D

D

D

D

D

D

D

d

D

D

D

D

d

H

D

D

D

D

D

D

D

d

D

D

D

D

d

d

d

D

D

D

D

D

D

d

Hydrogen peroxide

(STERIS V-PROt 1, V-PRO 1 Plus, V-PRO maX) Peracetic acid 04) (Just in time)

STERIS SYSTEM 1STERIS SYSTEM 1E™

x) Starting with product numbers “8...” / “4...”

01) Fully desalinated water is recommended for the final rinsing 02) Chemicals for reprocessing (see section 1.3)

Legend:

D

Permissible

d

Not permissible / not necessary

03) Detailed reprocessing information (see GA-J020)

Y Discard disposable item

05) Before use

H

04) Products are not packed sterile (see section 8.2.5)

5

See product-specific instructions for use

GA- J 050

RICHARD WOLF products Hygiene

2

Product variants

VIDEOSCOPES

FIBERSCOPES

FIBERSCOPES

Urology / ENT

Urology / Gynecology

ENT

Flexible Video Urethro-Cystoscope / PDD Video Urethro-Cystoscope with working channel and suction valve

Flexible Fiber Uretero-Renoscope with working channel

Flexible Bronchoscope / DAFE Bronchoscope with working channel and suction valve

Flexible Video Urethro-Cystoscope with working channel

Flexible 2-Channel Continuous Irrigation Laser URS

Flexible Nasopharyngo-Laryngoscope with working channel

with working channel and laser fiber channel

Flexible Video Bronchoscope / DAFE Video Bronchoscope with working channel and suction valve

Flexible Urethro-Cystoscope / Hysteroscope with working channel

Flexible Nasopharyngo-Laryngoscope

a) b) Flexible a) LED Video Urethro-Cystoscope b) LED Video-Bronchoscope with working channel and suction valve

Flexible Fiber Uretero-Renoscope with working channel

c) d)

c) BOA Vision Flexible Sensor URS with working channel d) COBRA Vision Flexible Sensor URS with working channel and laser fiber channel

GA-J 050

Fig. 1

6

RICHARD WOLF products Hygiene

2.1

Illustration

The reprocessing is described by example of the flexible video-urethro-cystoscope with working channel and suction valve. Depending on how the product variant is equipped, the description shall apply by analogy.

4.2.1

5

4.2.2

4.2

4.2.3

4.2.4

1/7

2 14

5.3 5.2 5.1

4.1

4 3 2 1

8.1 8.2 8.3

6 7

15 15.1

9

8

8.4

2

14

15

15.1

1

9

13

9 12

12.1

12.1

11

9

9 Legend and identification Item

Designation

Item

Designation

1 2

Working channel

8

Valve element

Luer connector

8.1

Valve tappet

3

Luer lock cap

8.2

Valve insert

4

Adapter

8.3

Tube connector

4.1

Irrigation, drain and insertion stopcock

8.4

Sealing membrane (disposable product)

9

Connector for leakage test and pressure equalization

4.2

7

9

12

Fig. 2 2.1.1

10

Stopcocks, complete for attachment with removable stopcocks

4.2.1

Stopcock plug

10

Adapter, projector to light cable

4.2.2

Stopcock housing

11

Camera cable

4.2.3

Luer connector

12

Camera plug

4.2.4

Passage identification on stopcock housing, stopcock plug

12.1

Protection cap for camera plug

5

Biopsy valve

Only for 2-channel continuous irrigation laser URS

5.1

Valve housing

13

Laser fiber channel

5.2

Sealing valve / transparent (disposable product)

14

Receptacle for laser adjustment unit

5.3

Sealing cap

15

Laser adjustment unit, complete

6

Valve holder

15.1

Fastening element, orange (disposable product)

7

Suction channel

GA-J 050

Reprocessing water Hygiene

3

Water quality

The water quality used for product reprocessing has a great influence on preserving the product 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 demine­ ralized water of a defined water quality in accordance with DIN EN 285, Appendix 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 or anlage_5_377

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

GA-J 050

8

Preparation of instruments Hygiene

4

Preparation of the instruments at the point of use

.

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: Fig. 3 Z Flexible endoscope ' Outside - Wipe the outside of the instruments with a lint-free disposable cloth

soaked in a certified cleaning agent / disinfectant.

' Inside - Rinse the inside with a certified cleaning / disinfectant solution.

.

IMPORTANT! To prevent the plastic outer coating from wrinkling or folding over, apply minimal pressure when wiping the distal end of the hose. In the case of wrinkling or folding over immediately fold back and smooth out the plastic outer coating carefully.

Fig. 3 Z Carefully put down instruments in order to avoid damage.

.

IMPORTANT! Carry out a leakage test immediately after each use and before each reproces­ sing. ' See section 6.3 "Manual leakage test" Z Dismantle flexible endoscope as far as necessary. ' See product-specific instructions for use

5.2

Fig. 4

8.4

Z Discard disposable items immediately. ' Sealing valve (5.2) ' Sealing membrane (8.4) ' Fastening element, orange (15.1)

15.1

Fig. 4

Fig. 5 Z Open inlet, outlet and instrument port stopcock (4.1).

4.1

Fig. 5

9

GA-J 050

Preparation of instruments Hygiene

4.1

Transport

4.1.1

Dry preparation at the point of use In the case of machine reprocessing in a washer/disinfector, dry preparation at the point of use should be the method of choice, because residues of the wet prepa­ ration solution (disinfectant) may jeopardize the cleaning result in the machine.

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

Z Carry out preparatory measures at the point of use: see section 4 4.1.2

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 contaminant residues drying on the instruments and prevent microbial 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.

4.1.3

Storage systems

4.2

Preparatory measures for machine and manual reprocessing

We recommend using the storage systems intended for transit in order to ensure safe and unproblematic transport to reprocessing. For further information please see: ' Section 11 “Accessories for reprocessing” ' RICHARD WOLF catalog pages “Hygiene - Reprocessing”

A contaminated camera plug (12) must be reprocessed manually before installing the protective cap (12.1). Z Immerse the camera plug (12) in a certified compatible cleaning and disinfec­ tant solution. 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. inter­ ruptions, poor contacts).

12

12.1

Fig. 6 Z Screw or install the protective cap (12.1) on the camera plug (12).

. IMPORTANT!

Reprocess the camera plug (12) of flexible endoscopes only with the protec­ tion cap (12.1) in place! If liquid enters the camera plug (e.g. because you forgot to put the cap on) carefully rinse out the plug with clear water and dry carefully (with compressed air if necessary).

12.1

12

Fig. 6

GA-J 050

10

Machine reprocessing Hygiene

5

Machine reprocessing

.

IMPORTANT! Before every machine reprocessing, the notes in the sections 6 and 6.1 must be observed and the following operations must be performed: ' Carry out manual leakage test (see section 6.3) ' Pre-clean flexible endoscope manually (see section 6.4) Instrument connectors Fig. 7 Z Treat instrument connections, which are covered by connecting tubes with a certified cleaning disinfectant solution before placing in the washer-disinfector (cleaning and disinfection machine for flexible endoscopes). Z Finally rinse off with water

Fig. 7

.

5.1

IMPORTANT! Z Only use a washer-disinfector (cleaning and disinfection machine for flexible endoscopes). Z The certified cleaning agent and disinfectant must be compatible with each other, with the procedure and with the flexible endoscope and the endoscopic accessories. Z In accordance with DIN EN ISO 15883 the user must validate the machine re­ processing procedures used. Z Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF pro­ ducts.

Auxiliary resources required

Z Lint-free disposable cloth and cotton swab Z Cleaning brushes ' See section 6.4 Z Storage systems ' We recommend using the RIWO BOX (see section 11). Z Washer-disinfector unit ' Observe the notes / instructions for use of the washer-disinfector unit manu­ facturer. ' Observe the notes in section 1.10 “Overview on reprocessing / material com­ patibility”.

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Machine reprocessing Hygiene

5.2

Heat-sensitive instruments

5.2.1

Chemo-thermal procedure

For machine reprocessing of heat--sensitive instruments we recommend using a chemo-thermal or a chemical procedure. In the chemo-thermal procedure the disinfection stage is carried out by adding disinfectant and increasing the temperature to 60_C (140° F). In the chemical procedure the disinfection stage is carried out by adding disinfec­ tant and without temperature exposure.

5.2.2

5.3

.

IMPORTANT! The following process parameters must be complied with: ' Irrigation pressure: max. 0.9 bar (13.0 psi) ' Temperature: max. 60_C (140° F)

.

IMPORTANT! The following process parameters must be complied with: ' Irrigation pressure: max. 0.9 bar (13.0 psi)

Chemical procedure

Connect flexible endoscope to washer-disinfector unit

Not necessary for pressure chamber devices. For machine reprocessing of the various flexible endoscopes, use the compatible rinsing set for machine recleaning, alternatively use rinsing tubes with correspon­ ding fittings / adapters. Z After connecting, check that the connections are tightly connected. Illustration

Product no.: Designation RICHARD WOLF adapter system

A1 A2

A3 A2

163.907

Rinsing set II for flexible

' Bronchoscope ' DAFE Bronchoscope

Rinsing set III for flexible 163.908

' Video Bronchoscope ' DAFE Video Bronchoscope ' LED Video Bronchoscope

Rinsing set V

A1 A1

163910

double luer connector for T-connection of flexible ' Fiber Uretero-Renoscope ' Video Urethro-Cystoscope ' PDD Video Urethro-Cystoscope ' LED Video Urethro-Cystoscope ' 2-channel continuous irrigation laser URS (2 x rinsing set V) ' BOA Vision Flexible Sensor URS ' COBRA Vision Flexible Sensor URS (2 x rinsing set V) ' Attachment (and additional rinsing tube)

Connectors / adapters

See section 11 “Accessories - reprocessing”

886.00 15028.083

Connector (A2)

15028.103

Connector (A3)

163914

GA-J 050

Luer lock tube fitting (A1)

Adapter for

' 2-channel continuous-irrigation laser URS ' COBRA Vision Flexible Sensor URS

12

Machine reprocessing Hygiene

5.3.1

Rinsing set II (163.907)

5.3.1.1

Connection to bronchoscopes Fig. 8 Z Connect rinsing set II to the luer connector (2) and valve holder (6) and connect to the washer-disinfector unit. ' Lock the connector (15028.083) to the valve holder (6) using the twist-lock mechanism. Z Alternatively, individual rinsing tubes from the washer-disinfector unit can also be used. ' Connect rinsing tube with - Luer lock tube connector (886.00) for the luer connector (2) - Fitting (15028.083) for valve holder (6) Connection in the washer-disinfector unit

15028.083 886.00

2

6

Fig. 8

5.3.2

Rinsing set III (163.908)

5.3.2.1

Connection to video bronchoscopes Fig. 9 15028.103

Z Push the connector (15028.103) to the unlocked position.

Fig. 9

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Machine reprocessing Hygiene

Fig. 10 Z Connect rinsing set III to the luer connector (2) and valve holder (6) and connect to the washer-disinfector unit. ' Lock the connector (15028.103) in place by pushing forward. ' Lock the connector (15028.083) to the valve holder (6) using the twist-lock mechanism. Z Alternatively, individual rinsing tubes from the washer-disinfector unit can also be used. ' Connect rinsing tube with - Fitting (15028.103) for luer connector (2) - Fitting (15028.083) for valve holder (6) Connection in the washer-disinfector unit

15028.083 15028.103

2

6

Fig. 10

5.3.3

Rinsing set V (163910)

5.3.3.1

Connection to video urethro-cystoscopes Fig. 11 Z Connect the rinsing tube to the connector (15028.083). Z Connect rinsing set V to the luer connectors (2), connect preassembled rinsing tube to the valve holder (6), and connect to the washer-disinfector unit. ' Alternatively, individual rinsing tubes from the washer-disinfector unit can also be used with the luer lock connector (886.00) at the luer connectors (2). ' Lock the connector (15028.083) to the valve holder (6) using the twist-lock mechanism. Connection in the washer-disinfector unit

15028.083

2 886.00

6

Fig. 11

GA-J 050

14

Machine reprocessing Hygiene

5.3.3.2

Connection to fiber ureterorenoscope / BOA Vision Flexible Sensor URS Fig. 12 Z Connect the rinsing set V to luer connectors (2) and connect to the washerdisinfector unit. ' Alternatively, individual rinsing tubes from the washer-disinfector unit can also be used with the luer lock connector (886.00) at the luer connectors (2). Connection in the washer-disinfector unit

2 886.00

Fig. 12 5.3.3.3

Connection to 2-channel continuous-irrigation laser URS / COBRA Vision Flexible Sensor URS Using two rinsing sets V Fig. 13 Z Connect the rinsing sets V to luer connectors (2) and connect to the washerdisinfector unit. ' Alternatively, individual rinsing tubes from the washer-disinfector unit can also be used with the luer lock connector (886.00) at the luer connectors (2). Connection in the washer-disinfector unit

2 886.00

2 886.00

Fig. 13 5.3.3.4

Connection to adapter (4)

Connection in the washer-disinfector unit

Fig. 14 Z Connect rinsing sets V and additional rinsing tube with luer lock tube (886.00) at luer connectors (4.2.3) and connect with the washer-disinfector. ' Alternatively, individual rinsing tubes from the washer-disinfector can also be used with the luer lock tube connector (886.00) at luer connectors (4.2.3).

4.2.3

886.00

Fig. 14

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GA-J 050