Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Small-caliber Resectoscope
for small anatomies
by Rösch
8677xxxx
Resectoscopes
for newborns and babies
8677.xxx / 8688.xxx
GA-D 363 / USA / 2013-05 V1.0 / ECO 2012-0641 (RW: 11-09-2.0 / PDI 09-4043)
Important general notes and instructions
Make sure that this product is used only as intended and described in this instruction manual, by adequately trained
and qualified medical personnel, and that maintenance and repair are only 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 applic
ation and if the performance characteristics and safety requirements are not impaired. Do not alter the product in any
way.
Reprocess the products before every application and before returning them for repairs as required by the instruction
manual in order 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.
Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the
shipment give right 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.
CAUTION :
Federal law restricts this device to sale by or on the order of a physician.
Safety instructions and levels of danger
Symbols Level of danger
WARNING!
Failure to observe can result in death or serious injury.
CAUTION!
Failure to observe can result in slight injury or damage to the product.
IMPORTANT!
. Failure to observe can result in damage to the product or surroundings.
NOTE!
. Tips for optimum use and other useful information.
USA GERMANY UK
RICHARD WOLF RICHARD WOLF GmbH RICHARD WOLF UK Ltd.
Medical Instruments Corporation 75438 Knittlingen Waterside Way
353 Corporate Woods Parkway Pforzheimerstr. 32 Wimbledon
Vernon Hills, Illinois 60061 Telephone: +49 70 43 35-0 SW17 0HB
Toll Free: 001 (800) 323 - 9653 Telefax: +49 70 43 35-4300 Telephone: + 44 20 89 44 74 47
Phone: 001 (847) 913 - 1113 info@richard-wolf.com Telefax: + 44 20 89 44 13 11
Fax: 001 (847) 913 - 1488 www.richard-wolf.com admin@richardwolf.uk.com
MANUFACTURER www.richardwolf.uk.com
sales@richardwolfusa.com
www.richardwolfusa.com
0 GA-D 363
Contents
1 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
6 Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6.1 Legend and identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.2 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
7 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7.1 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7.1.1 Adapter (4b) with 1 insertion port (stopcock) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7.1.2 Inserting the obturator (3) into the resectoscope sheath (2). . . . . . . . . . . . . . . . . . . . . . . 5
7.1.3 Inserting the PANOVIEW telescope (1) into the working element (5) . . . . . . . . . . . . . . 6
7.1.4 Inserting the electrode (6) or stricture scalpel (7) into the working element (5) . . . . . . 6
7.1.5 Inserting the working element (5) into the resectoscope sheath (2) . . . . . . . . . . . . . . . . 7
7.1.6 Inserting adapter (4a) or (4b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.1.7 Connecting the irrigation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2.2 Irrigation fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.3 HF applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.4 Inserting auxiliary instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
8 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8.1 Visual check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8.2 Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
GA-D 363 I
1 Technical description
The small-caliber resectoscope for small anatomies consists of:
Z PANOVIEW telescope 0
Z Resectoscope sheath, 14.5 Fr.
Z Working element
Z Electrodes
Z Stricture scalpels
2 Intended use
The resectoscopes are primarily used for endoscopically controlled ablation of
tissue. In conjunction with a stricture scalpel the resectoscopes can also be used
for the treatment e.g. of urethral strictures.
For examination and probing adapters are used.
Z PANOVIEW telescope 0
' for visualization of the patient's inside via natural accesses
Z Resectoscope sheath, 14.5 Fr.
consisting of:
Resectoscope sheath
' houses and automatically locks in place the working element
' provides continuous irrigation fluid supply
Obturator
' is used for atraumatic insertion of the resectoscope sheath into the urethra
Z Working element
' houses and locks in place the PANOVIEW telescope, electrode or stricture
scalpel
' is used for controlled insertion of the electrode or stricture scalpel into the
operating area under visual control
Z Electrodes
' are used for ablating, severing, cutting and coagulating soft tissue
Z Stricture scalpels
' are used for cold cutting, e.g. the cutting of urethral strictures
1 GA-D 363
3 Indications and field of use
For examination, diagnosis and / or therapy of the urogenital tract, preferably in
patients with narrow passages in conjunction with endoscopic accessories.
. IMPORTANT!
Select the correct product taking into account the patient group!
Based on the patient's anatomy and on his own experience and competence the
user must decide whether the available product set is suitable for use or whether
a bigger or smaller version of the corresponding products should be used.
4 Contraindications
Contraindications are inflammations or bacterial contaminations of wounds in the
operating area.
CJD - Creutzfeldt Jakob Disease or
vCJD - Variant of theCreutzfeldt Jakob Disease
BSE - Bovine Spongiform Encephalopathy; so-called mad cow disease
(e.g. Creutzfeldt Jakob Disease)
TSE - Transmissible Spongiform Encephalopathy
On the basis of the patient's general condition the doctor in charge must decide
whether the planned use is possible or not.
Comply with the laws and regulations valid in your country.
For further notes and instructions please refer to the latest medical literature.
Contraindications directly related to the product are currently unknown.
5 Combinations
The resectoscopes are used in conjunction with:
Z light sources and fiber light cables
Z HF surgical devices
Z pumps for irrigation or suction
Z endoscopic accessories, e. g.
' electrodes, stricture scalpels, forceps
CAUTION!
Do not combine products incorrectly!
Injuries of the patient user or others as well as damage to the product are
possible.
The different products may only be used together if their intended uses and
the relevant technical data (working length, diameter, peak voltage, etc.) are
the same.
Follow the instruction manuals of the products used in combination with this
product.
Follow the "Notes and instructions on HF applications", order no.: GA-S 002
as well as the HF device manufacturer's instructions.
CAUTION!
Do not use electrodes made by other manufacturers.
GA-D 363 2
6 Illustration
2.2.1
2.2.2
2.2 2.2.3
2 2.3
*
2.1 * 3.1
2.2.4
3
2.4 # * 3.2
#
4a ** 4.1
4.2 #
4b **
4
4.4.1
4.4.2 #
4.4.3 4.4 4.4 4.3
5.3
6.1 5.4
5
5.5
6 #
5.6
5.7
7.1
Fig. 1
3 GA-D 363
6.1 Legend and identification
Item Designation Item Designation
6.2 Symbols
Symbols Designation
Lot designation
Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or
packaging is marked with this symbol. Products of category IIa and above, as well as sterile pro-
ducts or products with measuring function of category I, are additionally marked with the code no. of
the notified body (0124).
GA-D 363 4
7 Use
CAUTION!
The products have only limited strength!
Excessive force will cause damage, impair the function and therefore
endanger the patient.
Immediately before and after each use, check the products for damage, loose
parts and completeness.
Make sure that no missing parts remain in the patient.
Do not use the products if they are damaged or incomplete or have loose parts.
7.1 Preparation
Z Check assembly: see section 9.4
Z Carry out a check: see sections 8 and 8.1
4.3
Fig. 2
7.1.2 Inserting the obturator (3) into the resectoscope sheath (2).
Fig. 3
Locking:
Z Insert the obturator (3) into the resectoscope sheath (2) in such a way that the
groove (a) and the pin (b) are aligned.
Z Push together until the locking mechanism (2.3) engages automatically.
. NOTE!
If the locking mechanism (2.3) won't engage, push the tab (2.4) as far as it will go
and repeat the procedure.
Unlocking:
Z Push the tab (2.4) and remove the obturator (3).
a b 2.4
2.3
2 3
Fig. 3
5 GA-D 363
7.1.3 Inserting the PANOVIEW telescope (1) into the working element (5)
Fig. 4
L The clamping lever (5.4) must be in position I.
Locking:
Z Introduce the PANOVIEW telescope (1) into the working element (5).
' The pin (c) engages in the groove (d).
Z Turn locking lever (5.4) to position II.
' Both components are locked together.
L The clamping lever (5.4) must be in position II.
Unlocking:
Z Turn locking lever (5.4) to position I.
' The clamping mechanism (5.5) is unlocked.
Z Remove the PANOVIEW telescope (1).
I I
II c d II
5
5.4
1
5.5
Fig. 4
7.1.4 Inserting the electrode (6) or stricture scalpel (7) into the working element (5)
Fig. 5
Locking:
Z Hold the electrode (6) or stricture scalpel (7), as shown in fig. 5, while sliding
5
the guide tube (6.1) / (7.1) over the PANOVIEW telescope (1).
5.1 Z Push and keep depressed the button (5.6), insert the electrode (6) or stricture
6 scalpel (7) into the electrode lock (5.1) as far as it will go.
1 Z Let go of the button (5.6).
Z Center the electrode (6), as shown in fig. 5a.
Z Pull slightly to check that the electrode (6) or stricture scalpel (7) is securely
connected.
Unlocking:
Fig. 5a Z Push the button (5.6) and pull out the electrode (6) or stricture scalpel (7).
6.1 / 7.1
5.6
6/7
1
5 5.1
Fig. 5
GA-D 363 6
7.1.5 Inserting the working element (5) into the resectoscope sheath (2)
Fig. 6
Z Same procedure as described under section 7.1.2.
2 5
Fig. 6
Fig. 7
7.2.1 Procedure
CAUTION!
Do not insert the resectoscope sheath (2) without the obturator (3)!
This may cause inadvertent tissue damage.
Insert the resectoscope sheath (2) atraumatically only with the obturator (3) in
place.
Z Insert the obturator (3) into the resectoscope sheath (2) and introduce: see section
7.1.2
Z Remove the obturator (3): see section 7.1.2
Z Insert the working element (5) with electrode (6) or stricture scalpel (7) and
PANOVIEW telescope (1) into the resectoscope sheath (2): see section 7.1.5
Fig. 8
Z Connect the fiber light cable to a suitable light source.
Z Plug in the HF connection cable and connect to the HF surgical device.
2.2
Z Open the irrigation stopcock (2.2).
Z Switch on the irrigation fluid supply.
7 GA-D 363
7.2.2 Irrigation fluid
CAUTION!
Irrigation fluid can be electrically conductive!
Depending on the application, a suitable low-conductivity irrigation fluid must be
selected by the user.
Do not use saline (NaCl) solution for HF applications.
CAUTION!
Danger of elevated temperatures when working without irrigation fluid!
Injuries of the mucous membrane due to excessive temperatures endanger the
patient.
Activate the electrode only while it is immersed in irrigation fluid and under conti
nuous irrigation.
7.3 HF applications
WARNING!
Danger of injury if the HF instrument is not visible through the scope!
Inadvertent tissue damage as well as damage to the distal end of the endoscope
and instrument parts are possible.
Use HF instruments only within the scope of their specifications (voltage strength,
duty factor).
Activate HF instruments only after the part conducting HF current has become
fully visible through the scope and contact is made with the desired area of use.
WARNING!
Explosion hazard if the electrode is activated in an air or gas bubble (e.g. roof of
the bladder)!
This may cause injuries of the bladder or uterus wall.
Activate HF current only if:
' the electrode is visible through the scope and is fully immersed in the irriga
tion fluid
' the desired tissue contact is made.
CAUTION!
Careful if HF voltage is too high!
Danger of injury resulting from damage to the electrode insulation!
Exceeding the maximum recurring peak voltage for the electrode in
combination with HF surgical devices and / or selecting the wrong mode can de
stroy the insulation and cause leakage currents.
Tissue in the patient, user or third parties may be destroyed.
Use electrodes in combination with HF surgical devices only with a maximum recur
ring peak voltage of 1.0 kV. Do not carry out forced coagulation or spray coagulation.
We recommend using the following power settings:
' cutting mode: 100 Watt
' coagulation mode: maximum 60 Watt
CAUTION!
Danger of HF arcing!
Insufficient distance between the parts conducting high-frequency current and other
conductive parts can lead to unintentional tissue damage and damage to the instru
ment.
During activation, live parts of HF instruments conducting high-frequency current
must have a safety distance of at least 2.5 mm from the distal end of the
2.5 mm endoscope (fig. 9).
In the case of HF arcing, replace the electrode immediately, check the
endoscope for damage and send it in for repair if necessary to avoid conse
Fig. 9 quential damage.
GA-D 363 8
CAUTION!
Do not use high power settings in the sphincter area!
This will cause thermal damage and may lead to a dysfunction of the sphincter.
When the tissue turns brown or black or is carbonized this is an indication of ex
cessive power.
Depending on the power or mode, the depth effect (necrosis) of the electrode is
approx. 0.5 to 2 mm. It is therefore necessary particularly in the area of the sphinc
ter to work carefully and with the lowest possible HF output.
CAUTION!
Do not activate HF current with the stricture scalpel in place!
The stricture scalpel is not insulated and may cause injuries of the mucous mem
brane if HF current is activated.
Disconnect the HF connection cable from the HF connector of the working
element before working with stricture scalpels.
CAUTION!
Careful if HF output power is incorrectly selected!
Injuries to the patient as well as damage to the product are possible.
The power should be set on the basis of the surgeon's experience / training re
garding the corresponding indication.
7.4 Inserting auxiliary instruments
When using the adapter with 1 insertion port (4b), flexible auxiliary instruments
corresponding to the size of the passage [see identification on the resectoscope
sheath (2)] and with a wokring length of at least 230 mm can be used.
CAUTION!
Danger of injury when introducing auxiliary instruments if these are not
visible through the scope!
Inadvertent tissue damage is possible.
Insert auxiliary instruments only under visual control.
Move the equipment in such a way that the auxiliary instruments are fully
visible through the scope.
CAUTION!
Danger of injuries as well as damage to the resectoscope when inserting or with
drawing forceps and scissors with open jaws!
Inadvertent tissue damage, damage to the distal end of the resectoscope as well
as loss of particles on the jaws are possible.
Introduce and retract forceps and scissors only with the jaw sections closed and
under visual control.
Fig. 10
Z Open the insertion port (stopcock) (4.4).
Z Insert and withdraw auxiliary instruments through the insertion port (stopcock)
(4.4) only in closed position.
4.4
Fig. 10
9 GA-D 363
8 Checks
CAUTION!
Be careful if products are damaged or incomplete!
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.
Return damaged products together with any loose parts for repair.
Do not attempt to do any repairs yourself.
8.1 Visual check
Z Check the instruments and accessories for the following:
' damage
' sharp edges
' loose or missing parts
' rough surfaces
Z Any lettering, labeling or identification necessary for the safe intended use must
be legible.
' Missing or illegible lettering, labeling or identification leading to wrong handling
and reprocessing must be reinstated.
Fig. 11
Fig. 11
Fig. 12
Z Check the insulation. Replace the electrode if
' the insulation is damaged
' the distal insulation is damaged.
Fig. 12
GA-D 363 10
8.2 Function check
Z Check the individual components for compatibility.
Z Check for secure connections.
Z Check the individual instrument for easy assembly and proper functioning of
the locking mechanism(s). Replace the instruments if the connection
' although locked is not secure.
' cannot be locked or is difficult to lock.
6 Fig. 13
Z Check the electrode (6) or stricture scalpel (7) for the correct position:
Y ' Insert the working element (5) into the resectoscope sheath (2) (section 7.1.5)
and fully retract the electrode (6) or stricture scalpel (7) by means of the passive
1 mm
working element (5).
7 In this end position, the loop (Y) of the electrode or the lancet / sickle of the stric
ture scalpel (7) should be approx. 1 mm behind the sheath edge. This is
Y essential to ensure trouble-free tissue ablation.
1 mm
Fig. 13
11 GA-D 363
9 Reprocessing and maintenance
WARNING!
Creutzfeldt Jakob Disease!
If the patient is suspected of having the Creutzfeldt Jakob Disease (CJD) or a
variant of the Creutzfeldt Jakob Disease (vCJD) or the latter have been dia
gnosed, adequate 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 regu
lations.
. NOTE!
Disassembly and assembly are shown and described in sections 9.1.1 and 9.4.1
by example of stopcock plug 2.2.1. Proceed in the same way with stopcock plug
4.4.1.
9.1 Disassembly before cleaning
Z Remove all auxiliary instruments.
Z Remove all connections between the resectoscope and the system
components.
Z Remove all parts used:
' Working element (5): see section 7.1.5
' PANOVIEW telescope (1): see section 7.1.3
' Adapter (4a) or (4b): see section 7.1.5
' Sealing cap (4.3): see section 7.1.1
' Electrode (6) or stricture scalpel (7): see section 7.1.4
2.2.2
Fig. 15
Fig. 16
2.2.1
With disassembly tool
Z Push the disassembly tool forward as shown in Fig. 16 as far as it will go and
push together.
' The stopcock plug (2.2.1) snaps out of the stopcock housing (2.2.2).
Z Remove the stopcock plug (2.2.1).
2.2.2
Fig. 16
GA-D 363 12
9.2 Illustrations for cleaning
Fig. 17
5.6
5 . IMPORTANT!
Thoroughly clean the working element (5), in particular in the area of the
Z 5.1 electrode lock (5.1) and the receptacle (Z) for the electrode or stricture
scalpel. Rinse out the receptacle (Z) with a cleaning gun.
In the case of urine salt deposits and / or disinfectant residues, HF arcing
may occur in the area of the button (5.6). If you observe any HF arcing, send
in the working element (5) to have it checked.
Fig. 17
Fig. 18
2.2.1 Z Clean the stopcock housing (2.2.2) and the stopcock plug (2.2.1) with a suitable
cleaning brush and rinse out.
2.2.2
Fig. 18
9.3 Checks
Z Carry out a check: see sections 8 and 8.1
9.4 Assembly before sterilization
. NOTE!
Before sterilization screw on the threaded connections only loosely
' to allow a sufficient flow of sterilization medium.
' to prevent stress cracks.
Tighten all screw connections before use.
2.2.2
Fig. 19
13 GA-D 363
9.5 Reprocessing procedures
The following tables contain a description of the reprocessing procedures for the indi
vidual products validated by Richard Wolf.
. IMPORTANT!
' When used as intended and when following the instruction manual, it is not ne
cessary to limit the number of possible reprocessing cycles.
' Careful and gentle handling of medical products during the entire reprocessing
process has an important effect on the service life of the products.
' Before returning defective products for repair, they must have gone through the
entire reprocessing cycle.
' The user is obliged to make sure that the reprocessing process including the
resources, materials and personnel is suited to yield the required results.
' Follow the national and international requirements on validation.
GA-D 363 14
Product: Resectoscope sheath, adapter, obturator
Reprocessing guide:
Preparation at the Directly after use, remove any coarse soiling from the products. If there are more than 6 hours between use and repro
point of use: cessing, rinse out the hollow spaces of the instrument with a 5 ml syringe filled with water. Do not use fixing agents
or hot water (>40C) as this will bake residues to the surfaces and may have a negative influence on the cleaning suc
cess. May use a pre-treat spray on the products prior to transport.
Transport: Safe storage in a closed container and transport of the products to the reprocessing room in order to avoid damage
to the products and contamination of the environment.
Precleaning: Disassembly before cleaning: see section 9.1
Rinse out the products with hollow spaces for 20 seconds or with 5 pressure surges using a water cleaning gun
(3 - 4 bar).
Manual Machine
Cleaning: 1.Rinse out narrow channels with a 5 ml syringe filled with 1.Manually preclean the products before machine
enzymatic cleaning solution. cleaning.
2.Immerse in an enzymatic cleaning solution for at least 2.Connect instrument channels to the luer connectors on
5 minutes, then brush inside. the lap carrier rack.
3.Brush outside with a soft brush for at least 5 seconds to Program
remove any residues.
' >4 min. of pre-washing with cold water
4.Finally thoroughly rinse out the products for at least 20
' Empty
seconds or, in pulsed mode, with 5 pressure surges
(3 - 4 bar) using a water cleaning gun. ' >6 min of washing with a cleaning agent at 55C
' Empty
' >3 min of neutralization*) with hot tap water (<40C)
' Empty
' >2 min of intermediate rinsing using hot tap
water (<40C)
' Empty
Disinfection: 1.Dry the products to avoid diluting the disinfectant solu Carry out thermal machine disinfection following the natio
tion. nal requirements regarding the A0 value (see DIN EN ISO
2.Immerse the products in an approved disinfectant solu 15883).
tion, allow to soak as specified by the manufacturer.
' Use a syringe to completely fill the channels with the
solution.
3.Finally rinse out the products thoroughly for at least
20 seconds or, in pulsed mode, with 5 pressure surges
(3 - 4 bar) using processed water**).
Drying: Manual drying: Dry the products in the drying cycle of the washer-dis
Dry the external surfaces on the products with a lint-free infector.
disposable cloth or dry in a drying cabinet. Dry any hollow If necessary, additional drying can be achieved manually
spaces with filtered compressed air. using a lint-free disposable cloth or swab or, alternatively,
in a drying cabinet. Dry hollow spaces with filtered com
pressed air.
Function check, Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the product is visually clean.
visual check, ' Carry out a visual check: see sections 8.1
maintenance:
Packaging: Package the products for sterilization as required by the standards.
Sterilization: Steam sterilize the products in Pre-Vac cycle with the following parameters:
' Temperature exposure time: 4 min at 132C +4°C (270F +7°F)
' Evacuation: 3x
' Drying time: 20 - 30 min
' Maximum sterilization temperature: 138C
Storage: Store the sterilized products in a restricted area at approximately 24°C / 75°F, with at least 4 air exchanges per
hour and a relative humidity that does not exceed 70%, in accordance with ANSI / AAMI ST79.
Additional It is the responsibility of the user to ensure that the reprocessing equipment has been installed, calibrated and
instructions: validated according to the manufacturer of the sterilizer specifications.
*) depending on the quality of the neutralization solution, add an acid based on citric acid.
**) use sterile water if manual disinfection is not followed by sterilization.
15 GA-D 363
Product: Working element
Reprocessing guide:
Preparation at the Directly after use, remove any coarse soiling from the products. Do not use fixing agents or hot water (>40C) as this
point of use: will bake residues to the surfaces and may have a negative influence on the cleaning success. May use a pre-treat
spray on the products prior to transport.
Transport: Safe storage in a closed container and transport of the products to the reprocessing room in order to avoid damage
to the products and contamination of the environment.
Precleaning: Disassembly before cleaning: see section 9.1
No special requirements.
Manual Machine
Cleaning: See section 9.2 Manually preclean the products before machine cleaning.
1.Rinse out the receptacle with a 5 ml syringe filled with Program
enzymatic cleaning solution. ' >4 min. of pre-washing with cold water
2.Immerse in an enzymatic cleaning solution for at least ' Empty
5 minutes, then brush inside. ' >6 min of washing with a cleaning agent at 55C
3.Brush outside of working element in particular in the ' Empty
area of the electrode lock and on the receptable of the
' >3 min of neutralization*) with hot tap water (<40C)
electrode with a soft brush for at least 5 seconds to
remove any residues. ' Empty
4.At the end, rinse the working element for at least ' >2 min of intermediate rinsing using hot tap
20 seconds. water (<40C)
' Empty
Disinfection: 1.Dry the products to avoid diluting the disinfectant solu Carry out thermal machine disinfection following the natio
tion. nal requirements regarding the A0 value (see DIN EN ISO
2.Immerse the products in an approved disinfectant solu 15883).
tion, allow to soak as specified by the manufacturer.
3.Finally rinse the products thoroughly for at least
20 seconds using processed water**).
Drying: Manual drying: Dry the products in the drying cycle of the washer-dis
Dry the external surfaces on the products with a lint-free infector.
disposable cloth or dry in a drying cabinet. Dry any hollow If necessary, additional drying can be achieved manually
spaces with filtered compressed air. using a lint-free disposable cloth or swab or, alternatively,
in a drying cabinet. Dry hollow spaces with filtered com
pressed air.
Function check, Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the product is visually clean.
visual check, ' Carry out a visual check: see sections 8.1
maintenance:
Packaging: Package the products for sterilization as required by the standards.
Sterilization: Steam sterilize the products in Pre-Vac cycle with the following parameters:
' Temperature exposure time: 4 min at 132C +4°C (270F +7°F)
' Evacuation: 3x
' Drying time: 20 - 30 min
' Maximum sterilization temperature: 138C
Storage: Store the sterilized products in a restricted area at approximately 24°C / 75°F, with at least 4 air exchanges per
hour and a relative humidity that does not exceed 70%, in accordance with ANSI / AAMI ST79.
Additional It is the responsibility of the user to ensure that the reprocessing equipment has been installed, calibrated and
instructions: validated according to the manufacturer of the sterilizer specifications.
*) depending on the quality of the neutralization solution, add an acid based on citric acid.
**) use sterile water if manual disinfection is not followed by sterilization.
GA-D 363 16
Product: Reprocessable electrodes, stricture scalpels
Reprocessing guide:
Preparation at the Directly after use, remove any coarse soiling from the products. Do not use fixing agents or hot water (>40C) as this
point of use: will bake residues to the surfaces and may have a negative influence on the cleaning success. May use a pre-treat
spray on the products prior to transport.
Transport: Safe storage in a closed container and transport of the products to the reprocessing room in order to avoid damage
to the products and contamination of the environment.
Precleaning: Disassembly before cleaning: see section 9.1
Dissolve any encrustations using 3% hydrogen peroxide solution (H2O2 solution).
Ultrasonic Place the products in a cleaning / disinfectant solution approved for ultrasonic cleaning baths.
cleaning: ' Exposure time: 5 min
' Frequency: 35 kHz
' Temperature max.: 45°C
After ultrasonic cleaning:
Rinse the products with water for 20 seconds, then brush with a soft brush to remove any residues.
Dry out products manually using a sterile, lint-free cloth or swab.
Manual Machine
Cleaning: 1.Immerse in a enzymatic cleaning solution for at least 1.Manually preclean the products before machine
5 minutes. cleaning.
2.Brush with a soft brush for at least 5 seconds to remove 2.Place the products in a small parts sieve or sieve tray of
any residues. the washer-disinfector.
3.Finally thoroughly rinse the products with water for at Program
least 20 seconds.
' >4 min. of pre-washing with cold water
' Empty
' >6 min of washing with a cleaning agent at 55C
' Empty
' >3 min of neutralization*) with hot tap water (<40C)
' Empty
' >2 min of intermediate rinsing using hot tap
water (<40C)
' Empty
Disinfection: 1.Dry the products to avoid diluting the disinfectant solu Carry out thermal machine disinfection following the natio
tion. nal requirements regarding the A0 value (see DIN EN ISO
2.Immerse the products in an approved disinfectant solu 15883).
tion, allow to soak as specified by the manufacturer.
3.Finally rinse the products thoroughly for at least
20 seconds using processed water**).
Drying: Manual drying: Dry the products in the drying cycle of the washer-dis
Dry the external surfaces on the products with a lint-free infector.
disposable cloth or dry in a drying cabinet. Dry any hollow If necessary, additional drying can be achieved manually
spaces with filtered compressed air. using a lint-free disposable cloth or swab or, alternatively,
in a drying cabinet. Dry hollow spaces with filtered com
pressed air.
Function check, Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the product is visually clean.
visual check, ' Carry out a visual check: see sections 8.1
maintenance:
Packaging: Package the products for sterilization as required by the standards.
Sterilization: Steam sterilize the products in Pre-Vac cycle with the following parameters:
' Temperature exposure time: 4 min at 132C +4°C (270F +7°F)
' Evacuation: 3x
' Drying time: 20 - 30 min
' Maximum sterilization temperature: 138C
Storage: Store the sterilized products in a restricted area at approximately 24°C / 75°F, with at least 4 air exchanges per
hour and a relative humidity that does not exceed 70%, in accordance with ANSI / AAMI ST79.
Additional It is the responsibility of the user to ensure that the reprocessing equipment has been installed, calibrated and
instructions: validated according to the manufacturer of the sterilizer specifications.
*) depending on the quality of the neutralization solution, add an acid based on citric acid.
**) use sterile water if manual disinfection is not followed by sterilization.
17 GA-D 363
10 Technical data and order data
10.1 Small-caliber resectocope for small anatomies
PANOVIEW telescope 0
1 8672430 total length = 334.4 mm; working length = 274 mm;
outside dia. Ø = 2.7 mm; direction of view = 0
Coagulation electrode
8416011
total length = 254 mm; fork / stem color = yellow / yellow
Cutting electrode
6 8416031
total length = 252.3 mm; fork / stem color = yellow / yellow
Hook electrode
8416091
total length = 253.3 mm; fork / stem color = yellow / yellow
GA-D 363 18
10.2 Resectoscope for babies
PANOVIEW telescope 0
1 8672.421 total length = 249.4 mm; working length = 189 mm;
outside dia. Ø = 2.7 mm; direction of view = 0
Adapter
4a 8677.254
total length = 68.4 mm; working channel / passage = 1 x 5 Fr.
Coagulation electrode
8416.994 sickle-shaped with distal ball; 90 retrograde, angled
total length = 169 mm; fork / stem color = yellow / yellow
Coagulation electrode
8416.01
total length = 168 mm; fork / stem color = yellow / yellow
6
Cutting electrode
8416.03
total length = 166 mm; fork / stem color = yellow / yellow
Hook electrode
8416.09
total length = 166 mm; fork / stem color = yellow / yellow
19 GA-D 363
10.3 Resectoscopes for newborns and babies
PANOVIEW telescope 0
1 8686.414 total length = 242.5 mm; working length = 185.5 mm;
outside dia. Ø = 1.9 mm; direction of view = 0
Obturator, 9 Fr.
3 8688.0147 total length = 156.6 mm; working length = 123.1 mm;
color code = white
Coagulation electrode
8688.994 sickle-shaped with distal ball; 90 retrograde, angled
total length = 170 mm; fork / stem color = white / white
Coagulation electrode
8688.91
total length = 169 mm; fork / stem color = white / white
6
Cutting electrode
8688.93
total length = 167.1 mm; fork / stem color = white / white
Hook electrode
8688.95
total length = 167.1 mm; fork / stem color = white / white
GA-D 363 20
11 Spare parts and accessories
Sealing cap
- 88.01
packaging unit = 10 / pkg.
Cleaning gun
- 6199.00
with 8 attachments and storage rack
The products can be combined as required provided the relevant technical data and intended uses are obser
ved. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard Wolf
or your Richard Wolf representative.
. NOTE!
To prevent damage during transport or shipment of the products we recommend
using the original packaging material.
21 GA-D 363
14 Warranty and Customer Service
Richard Wolf guarantees our instruments to be free from any defects in materials and workmanship under
normal use and service for one year. Richard Wolf general terms and conditions may be found on the
back of our invoice.
Parts delivered separately by Richard Wolf are subject to all of the same general terms and conditions for
our products, including the limitations of warranty and liability.
All products should be returned to Richard Wolf for any necessary or desired repair or part replacement.
No product repair or part replacement should be done other than by Richard Wolf unless the care and
instruction manual or other written information indicates that repair or part replacement is authorized. If
authorized, parts must be replaced only by parts supplied or specified by Richard Wolf, and product repair
and part replacement must be done in strict conformance with Richard Wolf specifications and
instructions for repair and part replacement, including post replacement testing and recalibration. Failure
to follow this requirement in any way can be dangerous to you, your personnel and your patients and
voids the warranty for the product repaired or the product in which the part was replaced and if the part
was supplied by Richard Wolf, for that part.
Delivery by Richard Wolf of technical documents such as circuit or other design diagrams does not
constitute authorization for product repair or part replacement. Richard Wolf instruments and other
products should never be modified or altered under any circumstances.
Contact Richard Wolf if you have any question (1) whether replacement of a part or a repair is authorized
by Richard Wolf, or (2) whether you have complete instructions and specifications for part replacement or
repair.
These instructions do not attempt to cover all details or variations in equipment, nor to provide for every
possible contingency to be met in connection with installation, operation, or maintenance. Should further
information be required or should problems arise which are not covered sufficiently for the purchaser’s
purpose, the matter should be referred to Richard Wolf Medical Instruments Corporation.
Our national sales and service offices, as well as our manufacturing facility, are located in Illinois. Trained
manufacturer’s representatives are located throughout the U.S. to serve you. For any questions
regarding these instruments, or to place an order, contact Richard Wolf customer service department at
847- 913- 1113 or 800- 323- WOLF (9653).
INSTRUMENT ORDERING POLICY
Richard Wolf reserves the right to make substitutions, if necessary, without prior notice.
REPAIR POLICY
Defective merchandise will be repaired or replaced at no charge to the customer, provided the customer
delivers such defective merchandise prepaid. Any repairs, maintenance or servicing of Richard Wolf
merchandise by anyone other than a factory authorized representative will render our warranty null and
void.
REPAIR SHIPMENTS
When returning your instrument for repair, we suggest that you prevent shipping damage to the
instrument by reusing the box that it was originally shipped in. Richard Wolf also recommends that the
instrument be insured for an amount to cover the cost of replacement.
IMPORTANT
For general safety and health reasons, Richard Wolf requires that you clean and sterilize all instruments
before returning them for repair. If instruments are received in an unsanitary condition, Richard Wolf will
clean and sterilize each instrument and add a $ 100.00 cleaning charge for each instrument requiring
cleaning.
GA-D 363 22