Richard Wolf
Richard Wolf ERAGON Range Forceps , scissors and handles Instructions for Use
55 Pages
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Page 1
Instructions for use
Forceps, scissors, and handles
GA-S027 / en / 2019-11 V10.0 / PK19-9850 /
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 prior permission of Richard Wolf GmbH.
Copyright © RICHARD WOLF GmbH
Subject to technical changes! Due to ongoing development, the product descriptions, illustrations and technical data may deviate slightly from the current state. For further information about our products please contact Richard Wolf GmbH or your representative.
Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300
www.richard-wolf.com
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GA-S027
Contents 1
General safety instructions and guidance for use ...
5
2
Safety instructions and levels of danger...
6
3
Symbols...
7
4
Product description...
8
5
Intended use...
9
6
Indications ... 15
7
Contraindications and side effects ... 15
7.1
Contraindications... 15
7.2
Side effects... 15
8
Combinations ... 16
9
Illustration ... 17
9.1 9.1.1
ERAGON modular, ERAGON modular mini, ERAGON modular micro forceps and scissors ... 17 Legend and labeling ... 17
9.2 9.2.1
ERAGON axial handles ... 18 Legend and labeling ... 18
10
Use ... 19
10.1
Preparation ... 19
10.2 10.2.1 10.2.2 10.2.3
Assembly ... 19 ERAGON modular, ERAGON modular mini forceps and scissors ... 19 ERAGON modular micro forceps and scissors ... 21 ERAGON axial handle... 22
10.3 10.3.1 10.3.2 10.3.3
Disassembly ... 23 ERAGON modular, ERAGON modular mini forceps and scissors ... 23 ERAGON modular micro forceps and scissors ... 24 ERAGON axial handle... 25
10.4 10.4.1 10.4.2 10.4.3
Handle with lock ... 26 ERAGON modular handle – working with locks ... 26 ERAGON modular handle – working without locks ... 26 ERAGON axial handle with lock ... 26
10.5 10.5.1 10.5.2 10.5.3
General notes and instructions for use... 28 ERAGON modular, ERAGON modular mini forceps and scissors ... 28 Overload protection with ERAGON modular micro forceps and scissors ... 28 ERAGON axial handles ... 29
10.6
HF application ... 30
11
Checks... 32
11.1
Service life ... 32
11.2
Visual checks ... 33
11.3
Function check ... 33
12
Reprocessing and maintenance ... 34
12.1
Required equipment ... 35
12.2
Reprocessing sequence – ERAGON modular micro... 37
12.3
Reprocessing sequence – ERAGON modular and modular mini ... 43
13
Spare parts and other products ... 50
14
Use, storage, transport, and shipping conditions ... 55
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14.1
4
Disposal of the product, packaging material, and accessories ... 55
GA-S027
1
General safety instructions and guidance for use The product must only be used as intended following the instruction manual by adequately trained and qualified medical 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 application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, 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 or user. 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. 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.
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2
Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.
CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.
ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.
NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.
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Symbols Symbols
Designation Follow the manual Follow the instruction manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Number, amount
Data Matrix Code
CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products. Is only valid if the product and/or packaging is marked with this identification. Products of category I, with the exception of sterile products and products with measuring function, are marked without the four-digit code number of the competent authority. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal 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.
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Product description The 3-part modular forceps and scissors system described in the instructions for use consists of different jaw inserts and sheath tubes, as well as various different handle variants. The individual components can be individually combined with each other, provided that the correct working length and diameter are used.
Fig. 1
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Intended use ERAGON HF TEM scissors 83940417
METZENBAUM SCISSORS MONO Ø 5 MM BNDL
The products are used for cutting and severing, as well as for coagulation and hemostasis. ERAGON HF grasping forceps
GA-S027
83882017
DISSECTOR FORCEPS MONO Ø 2 MM BNDL
83882027
ATRAUMATIC GRASPING FORCEPS MONO Ø 2 MM BNDL
83882037
GRASPING FORCEPS MONO Ø 2 MM BNDL
83902077
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83902217
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83902227
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83902237
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83902287
PYLORIC SPREADER MONO Ø 3.5 MM BNDL
83912077
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83912217
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83912227
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83912237
DISSECTOR FORCEPS MONO Ø 3.5 MM BNDL
83912287
PYLORIC SPREADER MONO Ø 3.5 MM BNDL
83921817
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83931817
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83931827
PLATE-SHAPED GRASPING FORCEPS MONO Ø 5 MM BNDL
83931837
GRASPING FORCEPS MONO Ø 5 MM BNDL
83931847
GRASPING FORCEPS MONO Ø 5 MM BNDL
83931857
GRASPING FORCEPS MONO Ø 5 MM BNDL
83931867
BABCOCK FORCEPS Ø 5 MM BNDL
83931877
BABCOCK FORCEPS Ø 5 MM BNDL
83931927
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83931947
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83931957
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83931977
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83931987
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83931997
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83932007
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
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83932107
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83932207
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83932407
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83932567
DEBAKEY FORCEPS MONO Ø 5 MM BNDL
83932587
DEBAKEY FORCEPS MONO Ø 5 MM BNDL
83932817
MARYLAND DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83932827
PETELIN DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83932837
MIXTER DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83932857
DOLPHIN DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83932877
GRASPING FORCEPS MONO Ø 5 MM BNDL
83932887
GRASPING FORCEPS MONO Ø 5 MM BNDL
83932897
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83934817
UNIVERSAL GRASPING FORCEPS MONO Ø 5 MM BNDL
83934827
UNIVERSAL GRASPING FORCEPS MONO Ø 5 MM BNDL
83934837
GRASPING FORCEPS MONO Ø 5 MM BNDL
83934857
GRASPING FORCEPS MONO Ø 5 MM BNDL
83934867
GRASPING FORCEPS MONO Ø 5 MM BNDL
83934877
GRASPING FORCEPS MONO Ø 5 MM BNDL
83941817
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83941847
GRASPING FORCEPS MONO Ø 5 MM BNDL
83941927
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83941947
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83941957
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83941977
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83941987
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83941997
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83942007
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83942207
ATRAUMATIC GRASPING FORCEPS MONO Ø 5 MM BNDL
83942407
DISSECTOR FORCEPS MONO Ø 5 MM BNDL
83942587
DEBAKEY FORCEPS MONO Ø 5 MM BNDL
83942817
MARYLAND DISSECTOR FORCEPS MONO Ø 5 MM BNDL
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83942924
GRASPING FORCEPS MONO Ø 5 MM BNDL
83942934
GRASPING FORCEPS MONO Ø 5 MM BNDL
The products are used for endoscopically controlled manipulation and dissection of soft tissue sections and organs, for grasping suture material and needles, as well as for coagulation and hemostasis. Use on the central circulatory or nervous system is excluded. ERAGON grasping forceps
GA-S027
83902087
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83902097
UNIVERSAL GRASPING FORCEPS Ø 3.5 MM BNDL
83902107
BABCOCK FORCEPS Ø 3.5 MM BNDL
83902187
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83902197
GRASPING FORCEPS Ø 3.5 MM BNDL
83902207
GRASPING FORCEPS Ø 3.5 MM BNDL
83902257
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83902267
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83912087
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83912097
UNIVERSAL GRASPING FORCEPS Ø 3.5 MM BNDL
83912107
BABCOCK FORCEPS Ø 3.5 MM BNDL
83912187
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83912197
GRASPING FORCEPS Ø 3.5 MM BNDL
83912207
GRASPING FORCEPS Ø 3.5 MM BNDL
83912257
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83912267
ATRAUMATIC GRASPING FORCEPS Ø 3.5 MM BNDL
83931887
GRASPING FORCEPS Ø 5 MM BNDL
83931897
GRASPING FORCEPS Ø 5 MM BNDL
83931907
DEBAKEY FORCEPS Ø 5 MM BNDL
83931917
DEBAKEY FORCEPS Ø 5 MM BNDL
83931937
GRASPING FORCEPS Ø 5 MM BNDL
83932237
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83932297
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83932307
GRASPING FORCEPS Ø 5 MM BNDL
83932427
BABCOCK FORCEPS Ø 5 MM BNDL
83932497
INTESTINE GRASPING FORCEPS Ø 5 MM BNDL
83932507
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83932917
DEBAKEY FORCEPS Ø 5 MM BNDL
83932925
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83932928
GRASPING FORCEPS Ø 5 MM BNDL
83932935
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
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83934887
MYOMA GRASPING FORCEPS Ø 5 MM BNDL
83934907
GRASPING FORCEPS Ø 5 MM BNDL
83934945
CLAW GRASPING FORCEPS Ø 5 MM BNDL
83941877
BABCOCK FORCEPS Ø 5 MM BNDL
83941897
GRASPING FORCEPS Ø 5 MM BNDL
83941937
GRASPING FORCEPS Ø 5 MM BNDL
83942237
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83942297
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83942307
GRASPING FORCEPS Ø 5 MM BNDL
83942427
ERAGON MODULAR FORCEPS Ø 5 MM BNDL
83942497
INTESTINE GRASPING FORCEPS Ø 5 MM BNDL
83942507
ATRAUMATIC GRASPING FORCEPS Ø 5 MM BNDL
83944907
GRASPING FORCEPS Ø 5 MM BNDL
83951877
BABCOCK FORCEPS Ø 10 MM BNDL
83952257
MARYLAND DISSECTOR FORCEPS Ø 10 MM BNDL
83952347
PLATE-SHAPED GRASPING FORCEPS Ø 10 MM BNDL
83954907
CLAW GRASPING FORCEPS Ø 10 MM BNDL
83961877
BABCOCK FORCEPS Ø 10 MM BNDL
83962047
GRASPING FORCEPS Ø 10 MM BNDL
83962257
MARYLAND DISSECTOR FORCEPS Ø 10 MM BNDL
83962267
DISSECTOR FORCEPS Ø 10 MM BNDL
83962347
PLATE-SHAPED GRASPING FORCEPS Ø 10 MM BNDL
83962367
GRASPING FORCEPS Ø 10 MM BNDL
The products are used for endoscopically controlled manipulation and dissection of soft tissue sections and organs, as well as for grasping suture material and needles. Use on the central circulatory or nervous system is excluded. ERAGON HF scissors
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83882007
SCISSORS MONO Ø 2 MM BNDL
83902157
METZENBAUM SCISSORS MONO Ø 3.5 MM BNDL
83902247
METZENBAUM SCISSORS MONO Ø 3.5 MM BNDL
83902277
HOOK SCISSORS MONO Ø 3.5 MM BNDL
83912157
METZENBAUM SCISSORS MONO Ø 3.5 MM BNDL
83912247
METZENBAUM SCISSORS MONO Ø 3.5 MM BNDL
83912277
HOOK SCISSORS MONO Ø 3.5 MM BNDL
83930417
METZENBAUM SCISSORS Ø 5 MM BNDL
83930457
SCISSORS MONO Ø 5 MM BNDL
83930817
HOOK SCISSORS MONO Ø 5 MM BNDL
83932437
METZENBAUM SCISSORS MONO Ø 5 MM BNDL
GA-S027
83932467
SCISSORS MONO Ø 5 MM BNDL
83932487
SCISSORS MONO Ø 5 MM BNDL
83940817
HOOK SCISSORS MONO Ø 5 MM BNDL
83942437
METZENBAUM SCISSORS MONO Ø 5 MM BNDL
83942467
SCISSORS MONO Ø 5 MM BNDL
83942487
SCISSORS MONO Ø 5 MM BNDL
The products are used for cutting and severing tissue, as well as for coagulation and hemostasis. Use on the central circulatory or nervous system is excluded. ERAGON HF biopsy forceps 83902167
DOUBLE SPOON FORCEPS MONO Ø 3.5 MM BNDL
83902177
FRIEDEL PUNCH MONO Ø 3.5 MM BNDL
83912167
DOUBLE SPOON FORCEPS MONO Ø 3.5 MM BNDL
83912177
FRIEDEL PUNCH MONO Ø 3.5 MM BNDL
83930917
BIOPSY EXTRACTION FORCEPS MONO Ø 5 MM BNDL
83930927
BIOPSY EXTRACTION FORCEPS MONO Ø 5 MM BNDL
83930937
BIOPSY EXTRACTION FORCEPS MONO Ø 5 MM BNDL
83940917
BIOPSY EXTRACTION FORCEPS MONO Ø 5 MM BNDL
The products are used for endoscopically controlled severing and removal of tissue, for biopsy extraction, as well as for coagulation and hemostasis. Use on the central circulatory or nervous system is excluded. ERAGON gastric band manipulators 83932537
GASTRIC BAND MANIPULATOR Ø 5 MM BNDL
83942537
GASTRIC BAND MANIPULATOR Ø 5 MM BNDL
83976547
GASTRIC BAND MANIPULATOR Ø 10 MM BNDL
The products are used for dissection, retraction, and bypassing of tissues and organs. ERAGON knot pusher 83943457
KNOT PUSHER Ø 5 MM BNDL
The products are used for fixing knots of intraoperative sutures and ligatures. Use on the central circulatory or nervous system is excluded. ERAGON HF TEM grasping forceps 83946217
TEM GRASPING FORCEPS MONO Ø 5 MM BNDL
83946227
TEM GRASPING FORCEPS MONO Ø 5 MM BNDL
83946237
TEM GRASPING FORCEPS MONO Ø 5 MM BNDL
83946247
TEM GRASPING FORCEPS MONO Ø 5 MM BNDL
The products are used for endoscopically controlled manipulation and dissection of soft tissue sections and organs, for grasping needles, as well as for coagulation and hemostasis.
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ERAGON rotatable wheel connector 8988
ROTATABLE WHEEL CONNECTOR
The products are used for enlarging and extending the grasping surface of the rotatable wheel, thus facilitating the operation of ERAGON instruments with an axial handle. User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.
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Indications The products are used for endoscopic interventions in different medical fields. These include: n n n n
Gynecology Urology Thoracoscopy Surgery
Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the attending physician must ensure that the product can be safely used in terms of its dimensions or settings.
7
Contraindications and side effects
7.1
Contraindications There are currently no known contraindications directly related to the products. If there are medical contraindications, use with the products concerned is excluded.
7.2
Side effects When used as intended, there are no known side effects directly related to the product.
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8
Combinations WARNING Incorrect combination of products! Injuries to the patient, user, or others, as well as damage to the product are possible. Only the instrument combinations listed in the supplementary sheets BB-S 027-x are permissible! The instructions for use of the products used in the product combination must be observed. Observe the "Notes on HF application", order no.: GA-S002 and those of the HF device manufacturer. The products are used with n n n n n n
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Endoscopic cameras and light sources Endoscopic devices Suction and irrigation pumps Endoscopic instruments and accessories Surgical instruments and accessories HF surgical generators
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9
Illustration
9.1
ERAGON modular, ERAGON modular mini, ERAGON modular micro forceps and scissors
Fig. 2
9.1.1
Legend and labeling
Item
Designation
1
Jaw insert
1.1
Jaw section / scissors
A
Without HF connection with lock
2
Sheath tube
B
With HF connection without lock
2.1
Pushbutton
C
With HF connection and lock
GA-S027
Item
Designation Handle variants:
17
Item
Designation
Item
Designation
2.2
Rotatable wheel
3a
Handle
4
Scissors / forceps jaw insert with sheath tube
3.1
HF port
4.1
Jaw section / scissors / forceps
3.2
Movable handle arm
4.2
Rotatable wheel
3.3
Lock
4.3
Pushbutton
3.4
Locking lever
3.5
Trigger
9.2
ERAGON axial handles
Fig. 3
9.2.1
Legend and labeling
Item
Designation
3b
Handle, axial
3.1
HF port
D
Handle, axial, with lock
3.2
Handle arm
E
Handle, axial, without lock with HF connection
3.3
Lock
F
Handle, axial, with lock, with HF connection
G
Handle, axial, with lock, not rotatable
H
Rotatable wheel connector
18
Item
Designation Handle variants:
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10
Use WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.
10.1
Preparation 1. Check assembly: Section 10.2 Assembly 2. Perform a visual check: Section 11.2 Visual checks 3. Connect the instrument to the HF generator via the HF connection cable (see accessories). 4. Check the power settings on the HF generator.
10.2
Assembly
10.2.1
ERAGON modular, ERAGON modular mini forceps and scissors Assemble the jaw insert (1) and the sheath tube (2) 1. Insert the jaw insert (1) into the sheath tube (2), if necessary turn it slightly so that the jaw insert can be pushed completely into the sheath tube as shown in Figure 4.
Fig. 4 2. Then turn the jaw insert (1) in the direction of the arrow as shown in Fig. 4 until it can be felt to engage. ð The connection is locked!
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Fig. 5: (ERAGON modular forceps and scissors, 5 and 10 mm) ⊳ The nose (a) on the sheath tube (2) and the groove (b) on the jaw insert (1) lie in one plane.
Fig. 5 Fig. 6: (ERAGON modular mini forceps and scissors, 3.5 mm) ⊳ The spring element (c) is spread on the proximal end of the sheath tube (2). ¯ Check whether the connection is locked by pulling on the jaw insert (1) and sheath tube (2).
Fig. 6 Assembling the sheath tube (2) and handle (3a) (Fig. 7 and Fig. 8) 1. Deactivate the lock (3.3) (if provided) as follows: ð Set the locking lever (3.4) to position I.
Fig. 7
NOTE Do not hold the movable handle arm (3.2) during assembly!
2. Insert the sheath tube (2) with mounted jaw insert (1) into the handle (3A). ð The sheath tube (2) automatically audibly engages. ð The movable handle arm (3.2) automatically moves upward.
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