HySafe Modular Micro System Instructions for Use

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express written prior permission of Richard Wolf GmbH. Copyright © RICHARD WOLF GmbH

Manufacturer RICHARD WOLF GmbH Pforzheimerstr. 32 75438 Knittlingen DEUTSCHLAND Telefon: +49 70 43 35-0 Telefax: +49 70 43 35-4300 www.richard-wolf.com

2

GA-S016

Contents 1 1.1

General notes and instructions for use... Structure of safety instructions...

2 2

2

Symbol...

3

3

Product description...

4

4

Intended use...

6

5

Indications...

7

6 6.1 6.2

Contraindications and side effects... Contraindications... Side effects...

9 9 9

7

Combinations...

9

8 8.1

Illustration... 10 Legend and identification... 10

9 9.1 9.1.1 9.2

Use... Assembly... Function of the star wheel... Disassembly...

11 11 12 12

10 10.1 10.2 10.3

Checks... Service life... Visual check... Function check...

14 14 14 15

11 11.1

Reprocessing and maintenance... 16 Reprocessing sequence - HySafe micro modular system... 17

12

Spare parts and other products... 22

13 13.1

Operating, storage, transport and shipping conditions... 24 Disposal of product, packaging material and accessories... 24

GA-S016

3

1

General notes and instructions for use

This product must only be used as intended and in accordance with the instruc­ tions for use by adequately trained and qualified medical experts. Maintenance and repair may only be carried out be authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Other combinations, accessories and wear and tear parts may only be used if these are explicitly designated for the intended use and do not impair the performance criteria or safety require­ ments.The product must not be altered. Reprocess the products and the accessories in accordance with the instructions for use before and after each use and before any return shipment to protect the patient, user and others. 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 or user. Immediately upon receipt check the product for completeness and possible dam­ age. Should the shipment give rise to a complaint, inform the manufacturer or supplier immediately. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

Subject to technical changes! Due to the constant further development of the products, descriptions, illustrations and technical data may deviate from the current state. For further information about our products please contact Richard Wolf GmbH or your representative.

1.1

Structure of safety instructions WARNING! This signal word is used to indicate a potentially dangerous situa­ tion. Not avoiding this situation can result in death or extremely serious injuries. CAUTION! This signal word is used to indicate a potentially dangerous situa­ tion. Not avoiding this situation can result in death or extremely serious injuries. CAUTION! This signal word without warning sign is used to indicate a poten­ tial danger of material damage. NOTE! This signal word draws the attention to useful information for the user such as easier operation and cross-references.

4

GA-S016

2

Symbol Symbols

Designation Follow the instructions for use

MD

Medical product

REF

Product number

LOT

Lot code Manufacturer

Manufacturing date Number, quantity Datamatrix Code CE identification with code number of the competent authority in conformity with Directive 93/42/EEC on medical products or EU regulation 2017/745 on medical products. Is only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE identification without code number of the notified body. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveral identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

GA-S016

5

3

Product description

The modular grasping forceps system consists of different grasping and biopsy forceps as well as scissors that can all be combined with the same modular han­ dle. The forceps and scissors are easy to clean because they can be disassem­ bled. Different kinds of jaw and scissor inserts are available. Hysafe spoon and biopsy forceps jaw inserts. 8642.6008 GRASPING FORCEPS JAW INSERT 10.5FR WL 340MM double action, WL 350mm, dismantlable, reusable

8952.6008 BIOPSY FORCEPS JAW INSERT WITH 5FR 550MM SHEATH

double action, WL 550mm, with irrigation connector, dismantlable, reusable

8645.6008 BIOPSY FORCEPS JAW INSERT WITH 7FR 340MM SHEATH

double action, WL 340mm, with irrigation connector, dismantlable, reusable

Hysafe grasping jaw inserts 8962.6008 GRASPING FORCEPS JAW INSERT 10.5FR WL 350MM

Aligator jaws, double action, WL 350mm, with irrigation connector, dismantlable, reusable

8962.6108 GRASPING FORCEPS JAW INSERT 10.5FR WL 350MM

Aligator jaws, double action, WL 350mm, with irrigation connector, dismantlable, reusable

8962.6048 GRASPING FORCEPS JAW INSERT 12FR

Aligator jaws, double action, WL 355mm, with irrigation connector, dismantlable, reusable

8962.6058 GRASPING FORCEPS JAW INSERT 12FR

Mouse tooth, double action, WL 340mm, with irrigation connector, dismantlable, reusable

8962.6078 GRASPING FORCEPS JAW INSERT 12FR

Peanut shape, fine toothing, double action, WL 340mm, with irri­ gation connector, dismantlable, reusable

8952.6118 GRASPING FORCEPS JAW INSERT 4FR WL 550MM

Mouse tooth, double action, WL 550mm, with irrigation connector, dismantlable, reusable

8952.6218 GRASPING FORCEPS JAW INSERT 5FR

Mouse tooth, double action, WL 550mm, with irrigation connector, dismantlable, reusable

6

GA-S016

8952.6508 GRASPING FORCEPS JAW INSERT 5FR

Aligator jaws short, double action, WL 550mm, dismantlable, re­ usable

8954.6808 GRASPING FORCEPS JAW INSERT 5FR

Aligator jaws long, double action, WL 550mm, with irrigation con­ nector, dismantlable, reusable

8959.6218 GRASPING FORCEPS JAW INSERT 5FR

Mouse-tooth, double action, WL 425mm, with irrigation connector, dismantlable, reusable

8959.6808 GRASPING FORCEPS JAW INSERT 5FR

Aligator jaws, double action, WL 425mm, with irrigation connector, dismantlable, reusable

8642.6508 GRASPING FORCEPS JAW INSERT 5FR WL 340MM

Aligator jaws, double action, WL 340mm, with irrigation connector, dismantlable, reusable

8968.6808 GRASPING FORCEPS JAW INSERT 6FR WL 425MM

Aligator jaws, double action, WL 425mm, with irrigation connector, dismantlable, reusable

8645.6508 GRASPING FORCEPS JAW INSERT 7FR

Aligator jaws, double action, WL 325mm, with irrigation connector, dismantlable, reusable

8992.6308 GRASPING FORCEPS JAW INSERT 7FR

Aligator jaws, WL 310mm, double action, reusable

8962.6028 GRASPING FORCEPS JAW INSERT 9FR WL 355MM

Grasping forceps, double action, WL 355mm, with irrigation con­ nector, dismantlable, reusable

HySafe scissor jaw insert 8992.6408 HOOK SCISSORS JAW INSERT 7FR

severing, WL 310mm, double action, reusable

8642.6818 SCISSOR JAW INSERT WITH SHEATH 5FR WL 340MM Micro scissors, single action, WL 340mm, with irrigation connec­ tor, dismantlable, reusable

GA-S016

7

HySafe punch jaw inserts 8642.6318 BIOPSY FORCEPS JAW INSERT WITH SHEATH 5FR 340MM

Punch, single action, WL 340mm, with irrigation connector, dis­ mantlable, reusable

HySafe Handles 8083.001 HANDLE WITH OVERLOAD PROTECTION dismantlable, reusable

4

Intended use HySafe spoon and biopsy jaw inserts 8642.6008

GRASPING FORCEPS JAW INSERT 10.5FR WL 340MM

8952.6008

BIOPSY FORCEPS JAW INSERT WITH SHEATH 5FR 550MM

8645.6008

BIOPSY FORCEPS JAW INSERT WITH SHEATH 7FR 340MM

The products are used to take tissue samples and to grasp tissue, as well as to extract foreign bodies in conjunction with HySafe handles. HySafe Grasping jaw inserts 8962.6008

GRASPING FORCEPS JAW INSERT 10.5FR WL 350MM

8962.6108

GRASPING FORCEPS JAW INSERT 10.5FR WL 350MM

8962.6048

GRASPING FORCEPS JAW INSERT 12FR

8962.6058

GRASPING FORCEPS JAW INSERT 12FR

8962.6078

GRASPING FORCEPS JAW INSERT 12FR

8952.6118

GRASPING FORCEPS JAW INSERT 4FR WL 550MM

8952.6218

GRASPING FORCEPS JAW INSERT 5FR

8952.6508

GRASPING FORCEPS JAW INSERT 5FR

8954.6808

GRASPING FORCEPS JAW INSERT 5FR

8959.6218

GRASPING FORCEPS JAW INSERT 5FR

8959.6808

GRASPING FORCEPS JAW INSERT 5FR

8642.6508

GRASPING FORCEPS JAW INSERT 5FR WL 340MM

8968.6808

GRASPING FORCEPS JAW INSERT 6FR WL 425MM

8645.6508

GRASPING FORCEPS JAW INSERT 7FR

8992.6308

GRASPING FORCEPS JAW INSERT 7FR

8962.6028

GRASPING FORCEPS JAW INSERT 9FR WL 355MM

The products are used for the removal of tissue residues and foreign bodies, for holding tissue and organs, for stone extraction and for the placement and with­ drawal of urological stents or catheters in conjunction with HySafe handles.

8

GA-S016

HySafe scissor jaw inserts 8992.6408

HOOK SCISSOR JAW INSERT 7FR

8642.6818

SCISSORS JAW INSERT WITH 5FR WL 340MM SHEATH

The products are used for cutting adhesions, for exposing tissue, for dissection and for severing soft tissue and suture material in combination wirh HySafe han­ dles. HySafe punch jaw inserts 8642.6318

BIOPSY FORCEPS JAW INSERT WITH 5FR 340MM SHEATH

The products are used to remove and sever soft tissue, cartilage and other nonosseos tissue, as well as for biopsies in conjunction with a HySafe handle. HySafe handles 8083.001

HANDLE WITH OVERLOAD PROTECTION

The products are used for mechanical operation and handling of the Hysafe in­ struments. User The poduct and the accessories are exclusively intended for use by specialized medical experts and may only be used by medically qualified and adequately trained persons.

5

Indications

The products are used for the following indications in hysteroscopy: Diagnostic hysteroscopy The following table shows a listing of the indications of the individual products. The same indications apply for the accessories of the medical products listed. Can the indication

Medical product

Diagnotic hysteroscopy 8642.6008

GRASPING FORCEPS JAW INSERT 10.5FR WL 340MM

X

8642.6318

BIOPSY FORCEPS JAW INSERT WITH 5FR 340MM SHEATH

X

8642.6508

GRASPING FORCEPS JAW INSERT 5FR WL 340MM

X

8642.6818

SCISSORS JAW INSERT WITH 5FR WL 340MM SHEATH

X

8645.6008

BIOPSY FORCEPS JAW INSERT WITH 7FR 340MM SHEATH

X

8952.6008

BIOPSY FORCEPS JAW INSERT WITH 5FR 550MM SHEATH

X

8992.6308

GRASPING FORCEPS JAW INSERT 7FR

X

8992.6408

HOOK SCISSORS JAW INSERT 7FR

X

GA-S016

9

The products are used for the following indications in urology: Lithotripsy in the kidney (a) Turmorectomy in the kidney (b) Diagnostic nephroscopy (c) Lithotripsy in the bladder (d) Turmorectomy in the bladder (e) Diagnostic cystoscopy (f) Removal of foreign bodies from the bladder (g) Lithotripsy in the ureter (h) Tumorectomy in the ureter (i) Percutaneous nephrolithotomy (PCNL) (j) The following table shows a listing of the indications of the individual products. The same indications apply for the accessories of the medical products listed.. Indication

Medical product a B c 8642.6008

GRASPING FORCEPS JAW INSERT 10.5FR WL 340MM [BIOPSY FORCEPS 5FR WL 340MM]

8642.6318

BIOPSY FORCEPS JAW INSERT WITH 5FR 340MM SHEATH

8642.6508

GRASPING FORCEPS JAW INSERT 5FR WL 340MM

8642.6818

d

e

f

g

h

i

j

X X

X X

X X

X X

X X

X X

X

X

X

SCISSORS JAW INSERT WITH 5FR WL 340MM SHEATH

X X X X X X

X X

8645.6008

BIOPSY FORCEPS JAW INSERT WITH 7FR 340MM SHEATH

X X

X X

8645.6508

GRASPING FORCEPS JAW INSERT 7FR

8952.6008

BIOPSY FORCEPS JAW INSERT WITH 5FR 550MM SHEATH

8952.6118

GRASPING FORCEPS JAW INSERT 4FR WL 550MM

X

X

8952.6218

GRASPING FORCEPS JAW INSERT 5FR

X

X

8952.6508

GRASPING FORCEPS JAW INSERT 5FR

X

X

8954.6808

GRASPING FORCEPS JAW INSERT 5FR

X

X

8959.6218

GRASPING FORCEPS JAW INSERT 5FR

X

8959.6808

GRASPING FORCEPS JAW INSERT 5FR

X

8962.6008

GRASPING FORCEPS JAW INSERT 10.5FR WL 350MM X

X

X

X

8962.6028

GRASPING FORCEPS JAW INSERT 9FR WL 355MM

X

X

X

X

8962.6048

GRASPING FORCEPS JAW INSERT 12FR

X

X

X

X

8962.6058

GRASPING FORCEPS JAW INSERT 12FR

X

X

X

X

8962.6078

GRASPING FORCEPS JAW INSERT 12FR

X

X

X

X

8962.6108

GRASPING FORCEPS JAW INSERT 10.5FR WL 350MM X

X

X

X

8968.6808

GRASPING FORCEPS JAW INSERT 6FR WL 425MM

X

8992.6308

GRASPING FORCEPS JAW INSERT 7FR

X

X

X

X

8992.6408

HOOK SCISSORS JAW INSERT 7FR

X X

X

X

X X X

X

X

X

X

Patient group The intended patient group is not limited with regard to ethnicity, age, sex, body height or weight. Before use the attending physician must make sure that with regard to its dimensions or settings the product can be safely used on or in the patient.

10

GA-S016

6

Contraindications and side effects

6.1

Contraindications Contraindications in hysterectomy directly related to the product are presently not known.The use of the products concerned is excluded if there are medical con­ traindications for hysterectomy, such as pregnancy. Contraindications in urology directly related to the product are presently not known. The use of the products concerned is excluded if there are medical con­ traindications for hysterectomy, such as pregnancy.

6.2

Side effects

7

Combinations

No side effects related to the products are known if the products are used as in­ tended.

CAUTION! Do not combine products incorrectly! Wrong product combinations may injure the patient, user or others, and damage the product. Combine the different products only if their intended uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in combination with these products. The products are used with Endoscopic cameras and light sources Endoscopic devices Suction and irrigation pumps Endoscopic instruments and accessories Devices for lithotripsy

GA-S016

11

8

Illustration

1.1

1.2

1.3

1.4 1.5 1.6

1 #

1.1.1

1.7

1.1.2 2.1 2.2

2.3

1.1.3 1.1

2.4

1.1.4 2

#

1.1.5 2.5

1.1.6 1.1.7

2.6 Fig. 1 8.1

12

Legend and identification Item

Designation

Item

Designation

1

Forceps attachment (jaw insert, complete)

2

Handle

1.1

Jaw insert

2.1

Locking sleeve

1.2

Sheath tube

2.2

Sliding sleeve

1.3

Position marking

2.3

Pull relief / overload protection

1.4

Ball catch

2.4

Movable grip

1.5

Luer connector

2.5

Fixed grip

1.6

Pull rod

2.6

Finger support

1.7

Star wheel

#

Product no.

1.1

Jaw variants

1.1.1

Pike-mouth grasping forceps

1.1.5

Mouse-tooth grasping forceps

1.1.2

Grasping forceps

1.1.6

Punch

1.1.3

Double-spoon / biopsy forceps

1.1.7

Schere

1.1.4

Alligator Grasping forceps

GA-S016

9

Use WARNING! The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. Do not use the products if they are damaged, incomplete or have loose parts. Make sure that no missing parts remain in the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. WARNING! Danger of injury if the instrument is not visible through the scope! Inadvertent tissue damage as well as damage to the distal end of the endoscope and to instrument parts is possible. Insert the instrument only under visual control. Manipulate the instrument only if it is fully visible through the scope.

9.1

Assembly

Hold the handle (2) by the sliding sleeve (2.2) and the forceps adapter (1) by the star wheel (1.7). Insert the forceps adapter (1) into the handle (2).

1.7

1

2.2

2

Fig. 2 The ball catch (1.4) and the pull rod (1.6) engage with a click. The movable grip (2.4) moves slightly as indicated by the arrow.

Fig. 3

2.4

Carry out a check: Section 10

GA-S016

13

9.1.1

Function of the star wheel

1.1

1.3

1

The star wheel (1.7) allows rotating the forceps adapters of the HySafe micro modular system into any position required for use (forceps attachment 360° fine pitch snap-in mechanism). The position marker (1.3) indicates the opening direction of the jaw section (1.1) of the forceps adapter (1).

1.7

Fig. 4 WARNING! Danger of injury when inserting and retracting instruments with open jaw inserts! Inadvertent tissue damage, damage to the distal end of the sheath tube / endoscope and to the jaw insert are possible. Insert and retract the instruments only with closed jaws and under visual control.

Fig. 5 9.2

Disassembly Hold the instrument with one hand by the rotary knob (1.7) and with your other hand by the sliding sleeve (2.2). Pull the forceps adapter (1) and the grip (2) apart. the movable grip (2.4) moves slightly in direction of arrow.

1.7 2 1

2.2 2.4

Fig. 6

14

GA-S016

HINWEIS! During disassembly the movable grip (2.4) should always remain freely movable. Pressure hinders disassembly and may cause a wrong position of the movable grip (2.4) (7a). In this case the movable grip (2.4) must first be moved to the locked position. (7b)

2.4

Fig. 7a

2.4

Fig. 7b

Fig. 7

2.3 2.4

CAUTION! Danger of damage if you try to close the handle! In disassembled condition the grip is locked. When closing the movable grip (2.4) by force the pull relief (2.3) will be overstretched. Do not forcefully close the disassembled grip!

Fig. 8

GA-S016

15

10

Checks WARNING! Injuries due to damaged or incomplete products! Injuries of the patient, user or others are possible. Run through the checks before and after each use. Do not use the products if they are damaged, incomplete or have loose parts. Do not attempt to do any repairs yourself. CAUTION! Send in damaged or incomplete products together with any loose parts for repair. Repair only by authorized experts.

10.1

Service life CAUTION! For the service life of the products, careful and gentle handling during use and during the entire reprocessing process is essential. When the medical products are used as intended and following the instructions in manufacturer's instructions for use, it is not necessary to limit the service life of the products. If one or several criteria of the checks described below are not met, the medical product must be replaced or returned for repair (by the original manufacturer or a repair facility authorized by the original manufacturer) if necessary.

10.2

Visual check CAUTION! The products have only limited strength! Carry out visual checks before and after each use. Do not use damaged products. Check the instruments, in particular their distal areas and the accessories for: damage surface changes (e.g. corrosion) damaged cutting edges / blades traumatizing geometries not complying with the intended use sharp edges loose or missing parts rough surfaces Any lettering or identification necessary for the safe intended use must be legible. Any missing or illegible lettering or identification leading to wrong handling or reprocessing must be reinstated.

16

GA-S016

Check the jaw sections for defective and corroded parts. The cutting edges of the jaws must be sharp.

WARNING! Damaged surface in the forceps joint area. The joint pin may loosen. Check for surface changes, such as hair cracks on the joint pin or jaws. Do not use products with damaged surfaces. Return the products for repair.

Fig. 9 10.3

Function check

Check the individual components for compatibility. Check for secure connections between the parts. Check all components for easy assembly. Replace the products if the connec­ tion is not secure or is difficult to assemble or screw together. Check that the jaws (1.1) open and close properly. If the jaws cannot be closed or opened - disassembling the handle: See section 9.2, page 14 - assembling the handle: See section 9.1, page 13 Check that the forceps adapter (1) can be rotated by means of rotary knob (1.7)

1.1

1

1.7

Fig. 10

GA-S016

17

11

Reprocessing and maintenance WARNING! The products and accessories are delivered in unsterile condition. If unsterile products are used there is the danger of infection for the patient, user and third parties. The products must be reprocessed at least once before their first use and before every further use. The user is obliged to make sure that the reprocessing process including the re­ sources, material and personnel, is suited to yield the required results. WARNING! Danger of transmitting microorganisms! To protect the service staff, all products that are sent in for repair must have been reprocessed according to the latest state of the art in hygiene. Follow the instructions for use. CAUTION! Use only cleaning agents and disinfectants whose efficacy and material com­ patibility with endoscopes and endoscopic accessories have been verified and approved by the manufacturer of the chemicals. Examples of suitable active substances for chemical disinfection: ­ Ortho­phthalaldehyde ­ Ethandial, didecyldimethylammonium chloride ­ Formacedal, glutardialdehyde ­ Sodium carbonate peroxyhydrate Disinfectants fulfilling the test criteria of the VAH (Association for Applied Hygiene), the FDA or other national certification authorities can also be used. Do not use disinfectants containing peracetic acid without corrosion pro­ tection, phenols or chlorine components for the reprocessing of RICHARD WOLF products. NOTE! Brand new products Before reprocessing remove all protection foils and shipping locks or clips from the products and the accessories. NOTE! For a list of reprocessing chemicals approved by Richard Wolf in terms of material compatibility with RIchard Wolf products, please see document GA-J055. This doc­ ument can be requested from Richard Wolf or downloaded from our website. RICHARD WOLF on the internet www.richard­wolf.com/en/solutions/processing NOTE! 1 brush pass: Move the cleaning brush forwards and backwards once.

18

GA-S016

11.1

Reprocessing sequence - HySafe micro modular system Materials required Designation

Richard Wolf (product no.)

Lint-free disposable cloth

-

Cotton swabs

-

Specification: - Solvent-resistant - Head made of 100% pure cotton - Swab carrier made of wood or plastic, not metal - Head diameter 3­5 mm Basin W 400 mm L 600 mm

509.81

or Basin W 200 mm L 552 mm

6860.901

Syringe 20 ml (Example)

-

Cleaning brush Ø 9 mm TL 400 mm, - Color: orange, for single use Cleaning brush - for single use

7970409

Cleaning brush

86.90

Water jet cleaning pistol / air cleaning gun

6199.00

Instrument oil

200.532

8691

For manual cleaning Cold tap water (drinking water quality)

-

For Sterilization Instrument basket, bndl. - Low, long

GA-S016

8584.1312

19

HySafe micro modular system Initial treatment at the point of use

1. Immediately after use remove coare soiling from the products. 2. If there are more than 6 h between use and reprocessing, rinse out any hollow spaces with cold tap water, narrow spaces (eg. stopcocks) with a 20ml syringe filled with water. Do not use any agents (e.g. aldehydes) or hot water (> 40 °C) for precleaning. These can bake residues to the surfaces. Do not rinse out with physiological saline. Saline may facilitate corrosion. Preparation for transport or shipment To avoid damaging the products and contaminating the environment it is necessary to store the products safely in a closed container. For a safe transport or shipment we recommend using the instrument basket, bndl, (model 8584.1312).

Disassembly before cleaning

Disassembly before cleaning see Section 9.2 Disassembly

CAUTION! Carry out either machine reprocessing or manual reprocessing. If machine reprocessing is possible it should always be preferred to manual reprocessing. Machine reprocessing Manual reprocessing Machine reprocessing Precleaning for the ma­ CAUTION! chine cleaning process

Never use metal or sharp-edged tools (e.g. metal brushes) for cleaning the products.

1. Rinse the products for 10 seconds under cold running tap water. 2. Rinse out the channels for 20 seconds or in pulsed mode by applying 5 pressure surges (2.5‑4.0 bar) using a water cleaning gun (e.g. model 6199.00) with cold tap water. 3. Carry out ultrasonic cleaning. Immerse the products in a certified cleaning / disinfectant solution. - Adhere to the applied concentration and exposure time specified by the manufacturer. - Fill the channels completely. Carry out ultrasonic cleaning following the requirements of the cleaning and disinfectant solution. Temper­ atures above 50 °C can cause blood incrustations. Machine cleaning

CAUTION! Do not use care products or drying aids Applying care products or using chemical drying aids (such as rinse aids) during the machine reprocessing process of endoscopes and endoscopic accessories can lead to functional, material-related and biocompati­ bility-related impairments. 1. Place the handle in a W/D basket. 2. Connect the sheath tube to the carrier rack of the W/D so that the channel is rinsed out. 3. Connect the luer connector of the instrument via the rinsing tube to the carrier rack of the W/D. 4. Check for secure connections. 5. Start the cleaning program of the W/D device. Machine disinfection Carry out thermal machine disinfection in accordance with the national requirements with regard to the A0 value (see DIN EN ISO 15883). Machine drying Dry the products in the W/D's drying cycle at maximum 100 °C. If necessary, additional manual drying can be achieved using a lint-free disposable cloth or, alternatively, a drying cabinet. Dry hollow spaces with filtered compressed air. Carry out checks and maintenance See Checks and maintenance

20

GA-S016