Instructions for use

Flexible
Sensor-Ureterorenoscope
BOA VISION
7355071,7355071US, 7355076, 7355076US

GA-D396 / en-US / 2020-08 V1.0 / PK20-0024 (RW: 2017-03 V2.0 / PK18-9297)

 Important general notes and instructions
Make sure that this product is used only as intended and described in this instruction manual and 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 appli­
cation and if the performance characteristics and safety requirements are met. The product must not be altered in any
way.
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 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.
CAUTION!
Federal law restricts this device to sale by or on the order of a physician.

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.
IMPORTANT!
. Failure to observe can result in damage to the product or surroundings.
NOTE!
. User tips for optimum device use and other useful information.

GERMANY USA UK
RICHARD WOLF GmbH RICHARD WOLF RICHARD WOLF UK Ltd.
75438 Knittlingen Medical Instruments Corporation Waterside Way
Pforzheimerstr. 32 353 Corporate Woods Parkway Wimbledon
Telephone: +49 70 43 35-0 Vernon Hills, Illinois 60061 SW17 0HB
Telefax: +49 70 43 35-4300 Toll Free: 001 (800) 323 - 9653 Telephone: + 44 20 89 44 74 47
MANUFACTURER Phone: 001 (847) 913 - 1113 Telefax: + 44 20 89 44 13 11
Fax: 001 (847) 913 - 1488 [email protected]
[email protected]
www.richard-wolf.com [email protected] www.richardwolf.uk.com
www.richardwolfusa.com
BELGIUM / NETHERLANDS FRANCE AUSTRIA
N.V. Endoscopie RICHARD WOLF France S.A.R.L. RICHARD WOLF Austria
RICHARD WOLF Belgium S.A. Rue Daniel Berger Ges.m.b.H.
Industriezone Drongen Z.A.C. La Neuvillette Wilhelminenstraße 93 a
Landegemstraat 6 F-51100 Reims A-1160 Vienna
9031 Gent Drongen Telephone: +33 3 26 87 02 89 Telephone: +43 14 05 51 51
Telephone: +32 92 80 81 00 Telefax: +33 3 26 87 60 33 Telefax: +43 14 05 51 51 45
Telefax: +32 92 82 92 16 [email protected] [email protected]
[email protected] www.richard-wolf.com
www.richard-wolf.be
Marketing Office INDIA
U.A.E RICHARD WOLF India Private Ltd.
RICHARD WOLF Middle East JMD Pacific Square
P.O. Box 500283 No. 211 A, Second Floor
AL Thuraya Tower 1 Behind 32nd Milestone
9th Floor, Gurgaon - 122 001
Room 904, Dubai National Capitol Region
Telephone: + 9 71 43 68 19 20 Telephone: + 91 12 44 31 57 00
Telefax: + 9 71 43 68 61 12 Telefax: + 91 12 44 31 57 05
[email protected] [email protected]
www.richard-wolf.com www.richard-wolf.com

0 GA-D396
Contents
1 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4 Contraindications and side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

4.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.1 Compatibility of BOA vision and camera controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.1 Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 . . . . . . . . . . . . . . . . . . . . . 3
5.2 Compatibility of BOA vision and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

6 Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1 Legend and identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.2 Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

7 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.1 Assignment of function keys (15) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.2 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.2.1 Adapter (8) (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.2.2 Biopsy valve cpl. (9) (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.3 Installing/removing the plug protection cap (14.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.4 Connecting the URS to the camera controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.5 Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.5.1 Deflecting the instrument tip (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.5.2 Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.5.3 Electrical current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
7.5.4 Image quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
7.6 Laser application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
7.7 HF applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.8 Auxiliary instruments and endoscopic accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.8.1 Inserting flexible auxiliary instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.8.2 Inserting the URS via a guide wire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

8 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.1 Visual check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.2 Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.2.1 Adapter (8) (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.2.2 BOA vision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.3 Carrying out a manual leakage test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9 Processing and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

9.1 Flowchart of the processing process „BOA vision“ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
9.2 Auxiliary resources required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
9.3 Channel connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
9.4 Remove/discard products before processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
9.5 Processing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
9.5.1 Processing procedure „BOA vision“ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
9.6 Flowchart of the processing process „Accessories“ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

GA-D396 I
9.7 Auxiliary resources required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
9.7.1 Processing procedure „Accessories“ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
9.8 Processing in case of repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

10 Technical data and order data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

11 Spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

12 Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

12.1 Disposal of product, packaging material and accessories . . . . . . . . . . . . . . . . . . . . . . . . 43

13 Warranty and Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

II GA-D396
1 Technical description
The Sensor-Ureterorenoscopes BOA vision (single channel)
comprise the following:
Z Flexible insertion sheath
Z Control housing with control lever
(with integrated position lock for 0 position)
Z Proximal, fixed supply cable with camera connector
Z Deflectable instrument tip +270°/-270°
Z Function keys on the handle
Z Integrated image sensor in the instrument tip
Z Integrated LED illumination in the handle
Z Working channel with biopsy port at 45 with two luer connectors

Accessories
Z Adapter (option)
Z Biopsy valve cpl. (option)
Z Universal sealing valve 1-6 Fr. (option) (single-use item)

In this manual, the Sensor-Ureterorenoscopes BOA vision will in the following be

called BOA vision or URS.

2 Indications for use

The flexible Sensor-Ureterorenoscopes BOA are used for visualizing body cavi­
ties and organs via natural and surgically created passages.
These products are exclusively intended for use by specialized medical personnel
and must only be used by medically qualified and adequately instructed persons.

3 Indications and field of use

For examination, diagnostics and/or therapy in conjunction with endoscopic acces­
sories.
The product is used in the following disciplines:
Z Urology
' urinary tract
' nephroscopy

CAUTION!
Caution if video signal processing fails!
This may delay or stop the operation.
There must always be an operable comparable device or a conventional system
on hand, so that the user can complete the operation if the video image or LED
illumination fails.

GA-D396 1
4 Contraindications and side effects
4.1 Contraindications
Contraindications directly related to the product are presently unknown. On the
basis of the patient's general condition the doctor in charge must decide whether
the planned use is possible or not.
For further notes and instructions please refer to the latest medical literature.
4.2 Side effects
No side effects are to be expected if the system is used as intended.

5 Combinations
BOA vision is used in conjunction with:
Z ENDOCAM LOGIC 5525 Camera Controllers
' LOGIC HD 552510x
' LOGIC HD LITE 5525201
' LOGIC 4K 5525301
Z Suction and irrigation devices
Z Lasers
Z Endoscopic accessories, e.g.
' Flexible forceps
' Laser fibers
' Stone baskets
' etc.

CAUTION!
Do not combine products incorrectly!
Injuries of the patient, user or others as well as damage to the product are possible.
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 this product.

2 GA-D396
5.1 Compatibility of BOA vision and camera controller

. IMPORTANT!
BOA vision are only compatible with the following Richard Wolf ENDOCAM LOGIC
5525 Camera Controllers:
' LOGIC HD 552510x: from software version R12.
Follow the instruction manual GA-A282
' LOGIC HD LITE 5525201: from software version R12.
Follow the instruction manual GA-A293
' LOGIC 4K 5525301: no limitation.
Follow the instruction manual GA-A336
Richard Wolf camera controllers with a lower software version can be retrofitted using
a software update.

. NOTE!
If a software update of a Richard Wolf camera controller is required, please con­
tact our customer service department.
RICHARD WOLF Service
www.richard-wolf.com/en-us/service-and-service-packages/

5.1.1 Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014

The device/system, in the following referred to as product, was tested in combination with Richard Wolf ENDOCAM LOGIC 5525
Camera Controllers (LOGIC HD 552510x, LOGIC HD LITE 5525201 and LOGIC 4K 5525301).

Guidelines and manufacturer's declaration - Electromagnetic emissions

The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment.
Emissions measurement / test Compliance Electromagnetic environment - Guidelines
The product uses HF energy for its internal function.
HF emissions to CISPR 11 Group 1 The HF emission level is extremely low and it is not likely to cause any
interference in nearby electronic equipment.
HF emissions to CISPR 11 Class B
The product is suitable for use in all establishments, including domestic
Harmonic emissions
Class A establishments. This also includes establishments directly connected to
to IEC 61000-3-2
the public low voltage power supply network that supplies buildings used
In conformity with IEC 61000-3-3 “Emission of voltage fluctuations for domestic purposes.
/ flicker"

Guidelines and manufacturer's declaration - Electromagnetic immunity

The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment.
Immunity tests IEC 60601 test level Compliance Electromagnetic environment - Guidelines

 8 KV contact discharge Floors should be wood, concrete or ceramic tile.

Electrostatic discharge (ESD)
Yes With floors made of synthetic material, the relative
to IEC 61000-4-2  15 KV air discharge humidity of the ambient air must be at least 30%.
 2 KV for power supply lines
Electrical fast transience, bursts Mains/line power quality should be that of a typical
 1 KV for input and output Yes
to IEC 61000-4-4 commercial or hospital environment.
lines
 1 KV line to line
Surge voltage (surges) voltage Mains/line power quality should be that of a typical
Yes
to IEC 61000-4-5  2 KV line to ground commercial or hospital environment.
voltage
0% UT * ; 1/2 period at 0.45,
90, 135, 180, 225, 270 and Mains/line power quality should be that of a typical
315 degrees commercial or hospital environment. If the user of
Voltage dips, short interruptions and sup­
the product requires continued operation during
ply voltage variations 0% UT * ; 1 Period Yes
power mains/line interruptions it is recommended
to IEC 61000-4-11 and that the product be powered from an uninterrupt­
70% UT * ; 25/30 Periods ible power supply or battery.
single-phase: at 0 degrees
Power frequency (50/60 Hz) magnetic Power frequency magnetic fields should be at lev­
field, 30A/m Yes els characteristic of a typical location in a commer­
to IEC 61000-4-8 cial or hospital environment.
* NOTE! UT is the line / mains voltage prior to application of the test level.

GA-D396 3
Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting
The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment.
Immunity tests IEC 60601 test level Compliance Electromagnetic environment - Guidelines
Portable and mobile RF communications equipment should
be used no closer to any part of the product, including ca­
bles, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmit­
ter.
Recommended separation distance:
d = 1.2 p P

d = 1.2 p P for 80 MHz to 800 MHz

Conducted HF interference 6 Vrms
to IEC 61000-4-6 150 kHz to 80 MHz Yes d = 2.3 p P for 800 MHz to 2.5 GHz
P = Nominal power output rating of the transmitter in watts
Radiated HF interference 3 V/m (W)
to IEC 61000-4-3 80 MHz to 2.7 GHz Yes (according to the transmitter manufacturer)
d = recommended separation distance in meters (m)
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey1, should be less than the
compliance level in each frequency range2.
Interference may occur in the vicinity of devices with the
following symbol:

REMARKS:
At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­
netic waves is affected by absorption and reflexion from buildings, objects and people.
1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio
and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic
site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance
level above, the product should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product.
2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which
are not life-supporting
The product is intended for use in an electromagnetic environment where HF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­
tions equipment and the product.
Separation distance as a function of transmitter frequency (m)
Rated nominal output power of 80 MHz to 800 MHz 800 MHz to 2.5 GHz
150 kHz to 80 MHz
thetransmitter (W)
d = 1.2 p P d = 1.2 p P d = 2.3 p P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be
determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W).
REMARKS:
At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­
netic waves is affected by absorption and reflexion from buildings, objects and people.

4 GA-D396
 WARNING!
Device operation may be jeopardized by other devices located in the immediate
vicinity or if devices are stacked.
Other devices located in the immediate vicinity or stacked devices may interfere
with each other and cause malfunctions, in particular if devices give off energy
(e.g. HF surgical devices).
If devices have to be arranged in this way, make sure that the devices work
properly.

WARNING!
Safety distance from portable HF communication devices.
Medical electrical devices can be influenced by mobile HF communication de­
vices.
Do not operate HF communication devices in the immediate vicinity of medical
electrical devices. Non-compliance can cause the power characteristics of the
device to be impaired.

WARNING!
Influence on interference immunity and interference emission.
Use only accessories or cables specified or supplied by the manufacturer.
Other accessories and cables can cause increased electromagnetic interference
or a reduced electromagnetic immunity of the device and lead to malfunctions.

CAUTION!
The product is intended to be used in professional healthcare facility environment
but exclude medical treatment areas with high powered medical electrical equip­
ment e.g.
' HF surgery
' MR system (Magnetic resonance imaging)
' CT system (Computer tomography)
' Diathermy
5.2 Compatibility of BOA vision and accessories
Z Adapter (option)
' is used for inserting auxiliary instruments through the working channel
' is used for connecting suction and irrigation components
Z Biopsy valve cpl. (option)
' provides a seal when inserting auxiliary instruments from 3-5 Fr. through the
working channel
Z Universal sealing valve 1-6 Fr. (option) (single-use item)
' is used for inserting auxiliary instruments from 1-6 Fr. through the working
channel

GA-D396 5
6 Illustration

8.4.1
8.4.3 8.4.2
8.4

8.4.4
8.3 11
2 8 8.2
10
3 8.1
7 9.3
1 6 9.2 9
6.1 9.1
3
4 5 #4

12 13 14

#5 #6 #7 14.2 14.1

15.2

#1 15

13 #3 #2 15.1

Fig. 1

6 GA-D396
6.1 Legend and identification
Item Designation Item Designation
1 Working channel 9 Biopsy valve cpl. (option)
2 Objective lens 9.1 Valve housing
3 Light exit 9.2 Sealing valve (single-use item)
4 Instrument tip, controllable 9.3 Valve cap
Universal sealing valve 1-6 Fr (option)
5 Flexible instrument sheath 10
(single-use item)
6 Irrigation connector 11 Rubber cap
Connector for leakage test and pressure
6.1 Luer sealing cap 12
equalization
7 Luer fitting 13 Control lever
8 Adapter (option) 14 Supply cable
8.1 Locking ring 14.1 Camera plug
8.2 Supply and drain stopcocks 14.2 Plug protection cap
8.3 Instrument port stopcock 15 Function keys
8.4 Stopcocks, with removable plug 15.1 Function key 1 (left)
8.4.1 Stopcock plug, complete 15.2 Function key 2 (right)
8.4.2 Stopcock housing
8.4.3 Luer fitting
Indication of passage on
8.4.4
Stopcock housing/stopcock plug
# Further identifications:
#1 Product no. #5 Follow the instruction manual
IPX7
#2 CE 0124 #6 (Protected against the effects caused by temporary
immersion in water)

Deflection of instrument tip

Recycle the product separately. Do not dis­
#3 U = Up Move the control lever to distal #7
card together with other waste.
D = Down Move the control lever to proximal

#4 Working channel in Fr.

GA-D396 7
6.2 Symbol
Symbol Designation

Follow the instruction manual

Follow the manual

REF Order number

SN Series no.

LOT Lot identification

Manufacturing date

Manufacturer

Do not reuse

Do not resterilize

Number, amount

Expiry date

STERILE EO Sterilized with ethylene oxide

Do not use if package is damaged

Keep away from sunlight

XX°
Limitation of temperature
XX°

XX%
Limitation of humidity
XX%

IPX7 Protected against the effects of temporary immersion in water.

Recycle the product separately. Do not discard together with other waste.

Rx
ONLY
Federal law restricts this device to sale by or on the order of a physician.

Identification in conformity with Medical Product Directive 93/42/EEC, only valid if the product and/or
the packaging is marked with this identification. Products of category IIa and above, as well as sterile
products or products with measuring function of category I, are additionally marked with the code no. of
the notified body (0124).

8 GA-D396
7 Use
WARNING!
Unsterile use of products can transmit diseases!
The products are delivered unsterilized. To protect the patient, user and third par­
ties, the products must be processed in accordance with the manual
' prior the initial use
' before each subsequent use
' before return shipment
Informations regarding the processing of the accessories
' see chapter 9.7

WARNING!
Multiple use of disposable items!
The service life of products marked as disposable, i.e. for single use only, has
been designed for only one use in or on a single patient.
Multiple uses can impair and or change the product properties and therefore endan­
ger the patient, user and others.
Possible dangers / risk factors:
' Strength problems
' Severe impairment of the function
' Damage to the product
' Substantially increased risk of infection
' Biocompatibility problems
In the case of multiple uses, the product responsibility lies with the user.
In this case the manufacturer can no longer guarantee the safety and perfor­
mance of the product.

WARNING!
24­hour multi­patient use!
To ensure patient safety, only sterile fluids and sterile irrigation accessories, with
device components that are used on a single procedure at a time should be used
(e.g., 24­hour multi­patient use accessories are not recommended).

CAUTION!
The products have only limited strength!
Excessive force will cause damage, impair the function and therefore endanger
the patient.
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.

. NOTE!
When connecting the URS to the camera controller, white balance is never ne-
cessary.
The configuration of illumination and image generation allows a one time white
balance. This factory white balance is stored on the URS.

GA-D396 9
7.1 Assignment of function keys (15)
Fig. 2
15.2 The function keys (15.1) (15.2) are predefined by the application profile set on the
camera controller, but can be changed by the user at any time.
For this applied part the “flex. SensorSCOPES“ application profile is recommended.

15

15.1
Fig. 2

7.2 Preparation

. NOTE!
The following products can be attached to the luer fitting (7):
' Biopsy valve cpl. (9) (option)
' Adapter (8) (option)
' Universal sealing valve 1-6 Fr. (10) (option)
' Other commercially available disposable (single-use) stopcocks and valves

Z Immediately before and after each use, check the products for damage, loose
parts and completeness.
' Carry out a check: see sections 8 and 8.1

7.2.1 Adapter (8) (option)

Installing the adapter (8)
Fig. 3
8.4.1
Z Connect the stopcock plug (8.4.1).
Z Place the rubber cap (11) onto adapter (8).

. NOTE!
Optionally, the biopsy valve cpl. (9) or the universal sealing valve 1-6 Fr. (10)
8 can be installed instead of the rubber cap (11).
11

Fig. 3

10 GA-D396
 Fig. 4
Z Pull and hold the locking ring (8.1) as indicated by the arrow as far as it will go.
Z Engage the luer fitting (7) in the slot of the locking ring (8.1) and let go of lock­
ing ring (8.1).
' The locking ring (8.1) must return to its home position.
Z Close the irrigation connector (6) with a luer sealing cap (6.1).

6.1

8.1 6

Fig. 4

Connecting the supply and drain tubes

Fig. 5
Z Connect the supply and drain tubes to the supply and drain stopcocks (8.2).
Z Open the supply and drain stopcocks (8.2).
8.2 Z Switch on the suction and irrigation system and check the suction and irrigation
function.
Z Check the entire system for leak-tightness and free passage (patency).
Z Carry out a function check: see section 8.2

Fig. 5

7.2.2 Biopsy valve cpl. (9) (option)

Assembling the biopsy valve cpl. (9) (option)
9 9.3
6.1 Fig. 6
Z Check assembly.
6 7 ' See section 9.7.1, page 40
Z Screw on the valve cap (9.3) and tighten.
Z Screw the biopsy valve cpl. (9) onto the luer fitting (7).
Z Close the irrigation connector (6) with a luer sealing cap (6.1).

. NOTE!
Optionally, the universal sealing valve 1-6 Fr. (10) can be mounted to the
Fig. 6 biopsy valve cpl. (9).

GA-D396 11
 Connecting the irrigation tube
Fig. 7
Z Remove the luer sealing cap (6.1).
Z Connect the irrigation tube to the irrigation connector (6).
Z Switch on the irrigation system and check the irrigation function.
Z Check the entire system for leak-tightness and free passage (patency).

10 6.1

Fig. 7

Z Carry out a function check: see section 8.2

7.3 Installing/removing the plug protection cap (14.2)

. IMPORTANT!
Place the plug protection cap (14.2) fully onto the camera plug (14.1) as shown in
the figure.
Holding the plug protection cap (14.2) by the sides facilitates the installation or
removal.

14.2

Fig. 8 14.1

12 GA-D396
7.4 Connecting the URS to the camera controller

. IMPORTANT!
The supply cable has only limited strength.
Applying excessive force or high mechanical loads can cause damage to the supply
cable or wiring, resulting in image interference or image and illumination failure.
Z Do not pinch, squeeze or excessively bend the supply cable.
Z Do not pull on the supply cable.

Fig. 9

Fig. 10
Z Remove the plug protection cap (14.2) from the camera plug (14.1).
14.2 14.1 14

Fig. 10

GA-D396 13
 Fig. 11
Z Switch on the camera controller.
Z After the controller has booted connect the URS via the camera plug (14.1) to
the camera controller
' LOGIC HD 552510x
' LOGIC HD LITE 5525201
' LOGIC 4K 5525301
Z Select the “flex. SensorSCOPES“ application profile in the controller menu.
' For further information see GA-A282, GA-A293 and GA-A336

CAUTION!
Danger of dazzling!
Danger of impaired sight.
Do not look into the light exit area of a URS connected to a camera controller.

14.1

Fig. 11

7.5 Additional notes and instructions for use

CAUTION!
Danger of transmitting microorganisms!
To prevent contamination of the camera plug when disconnecting it from the
camera controller during the course of an operation, install plug protection cap
immediately after disconnecting the plug.
A contaminated camera plug must be processed as described under section 9.5.1,
page 29.
Residual moisture in the contacts can impair signal transmission (e.g. interruptions,
poor contacts).
The plug protection cap remains in place during the entire reprocessing process.

CAUTION!
Limited strength of the URS!
High forces and excessive mechanical loads can cause damage and impair the
function.
Do not kink the flexible instrument sheath and do not bend it to an excessively
small radius (minimum 150 mm diameter) (Fig. 12).

Fig. 12

14 GA-D396
 CAUTION!
The deflectable instrument tip may be blocked due to external causes (such as
limited free space)!
This may damage the controls. If the instrument tip is blocked, do not use force
when actuating the control lever.
Z Move the instrument tip to a position that allows control without applying force.
' See section 7.5.1

7.5.1 Deflecting the instrument tip (4)

. NOTE!
The straight position of the instrument tip (4) (0° position) is indicated by a notch
(snap in position) on the control lever, complete (13).
Fig. 13
Deflecting (i.e. controlling, angling) the tip
Z Actuate the control lever (13).

Movement
Direction Deflecting Model
of control lever
up (U) 270 distally
7355076,
down (D) 270_ proximally 7355076US

up (U) 270 proximally

7355071,
down (D) 270_ distally 7355071US

4
up

proximally
down
distally
Fig. 13 13

7.5.2 Light

WARNING!
Intense heat due to high light energy!
Danger of inadvertent tissue damage
' due to insufficient distance between the light exit area and the tissue
' due to soiling/contamination in the light exit area
Do not touch the light exit area and avoid direct contact with the tissue.
Follow the described instructions
Z Remove any soiling.
' see section 8.2.2

WARNING!
Fire hazard!
When placing the endoscope onto heat-sensitive flammable surfaces (dark
drapes etc.) the high light energy at the light exit area of the endoscope can cause
high temperatures or even ignition.
Store the endoscope in a safe place.

GA-D396 15
7.5.3 Electrical current

. IMPORTANT!
Use only products with type BF applied parts in conjunction with the URS.
WARNING!
Danger of electric shock!
Patient leakage currents can add up if the endoscopes are combined with other
powered endoscopic accessories.
Make sure that the combinations do not exceed the permissible patient leakage
currents.
7.5.4 Image quality

CAUTION!
Increased risk potential if the image is blurred!
Danger of injuring the patient.
Stop the intervention for safety reasons if the image is blurred.
Z Before use, check the image quality of the URS.
' see section 8.2.2
7.6 Laser application
When applying a laser make sure you follow the laser device manufacturer's in­
structions as well as the general regulations on the use of lasers.
Wear the required personal protection equipment.

CAUTION!
Do not work outside the scope's field of view!
Inadvertent tissue damage as well as damage to the distal end of the URS and to
instrument parts is possible.
Z Activate the laser only after
' the tip of the laser fiber is fully visible through the URS and
' the pilot beam makes contact with the area to be treated.

CAUTION!
High temperatures due to highly coherent laser beam!
The heat generated by the laser beam reduces the strength of instrument parts.
Do not direct the laser beam at instrument parts, in particular not at plastic parts.
Keep a safe distance.
CAUTION!
Danger of destroying the working channel by the sharp distal end of the laser fiber!
The stronger (stiffer) the laser fiber the bigger the danger that the sharp distal end
of the laser fiber destroys the working channel.
Z The laser fiber must therefore be inserted in the working channel or retracted
from the working channel, respectively, carefully and only with straight instru­
ment sheath and when the instrument tip is straight (0 position).

CAUTION!
Danger of destroying the instrument by a broken laser fiber!
If the instrument tip is angled (small bending radius) this increases the danger of
a fracture of the laser fiber and even more so with increasing laser fiber diameter.
A fracture of the laser fiber within the instrument channel while the laser energy is
active will immediately destroy the instrument.
In the latter case, switch off the laser energy immediately.
When using highly flexible laser fibers with a maximum permissible laser fiber dia-
meter of 365 m only a reduced deflection of the instrument tip is possible.
CAUTION!
Increased danger of laser fiber breakage if there is no protective coating or jacket!
We recommend removing only 1 mm of the laser fiber jacket at the distal tip.

16 GA-D396
7.7 HF applications
WARNING!
Danger of injury from HF application!
HF applications can lead to thermal tissue damage to the patient, user or others as
well as damage to the distal end of the URS.
HF applications with the URS are not permissible.

7.8 Auxiliary instruments and endoscopic accessories

7.8.1 Inserting flexible auxiliary instruments
WARNING!
Danger of injury if the auxiliary instrument is not visible through the scope!
Inadvertent tissue damage as well as damage to the distal end of the URS and to
instrument parts is possible.
Follow the below instrucion to avoid injury:
Z Insert auxiliary instruments only under visual control.
Z Carry out manipulations only if the auxiliary instruments are completely visible
through the URS.
Z Make sure the instrument tip is straight when inserting or withdrawing the auxiliary
instrument into/from the working channel.
Fig. 14
Through the instrument port stopcock (8.3), the biopsy valve cpl. (9) or the univer­
sal sealing valve 1-6 Fr. (10), auxiliary instruments such as the flexible biopsy
forceps can be inserted if necessary.
Z Open the instrument port stopcock (8.3) on adapter (8) and insert the auxiliary
instrument.

. IMPORTANT!
Use only flexible auxiliary instruments with a maximum outer diameter of 3 Fr.

8.3

10
8

Fig. 14

GA-D396 17
 Fig. 15

CAUTION!
To avoid damage to the working channel and biopsy valve cpl.,
' do not apply force when inserting auxiliary instruments in the working
channel or withdrawing them from the latter (Fig. 15a)
' insert and withdraw auxiliary instruments through the working channel only
when the instrument tip is straight. (Fig. 15b)
Z Angle (deflect) the URS only after the auxiliary instrument has become fully
visible through the scope.
Z It is then possible to further extend the auxiliary instrument with the instrument
tip in angled position, but it may only be retracted up to shortly before the in­
strument tip (4) (Fig. 15c).

Fig. 15a Fig. 15b Fig. 15c

Fig. 15

7.8.2 Inserting the URS via a guide wire

CAUTION!
Danger of destroying the working channel due to the rigid proximal end of the
guide wire!
When inserting the URS into the operating field via the proximal rigid end of the
guide wire, incorrect handling may destroy working channel.
To aviod the above, before insertion make sure that
Z the instrument sheath and the instrument tip are straight
Z the URS is only inserted via the working channel

18 GA-D396
8 Checks
CAUTION!
Be careful if products are damaged or incomplete!
Injuries of the patient, user and others are possible.
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.
Z Run through the checks before and after each use.

8.1 Visual check

Z Check the BOA vision, in particular in the distal area, and check the ac­
cessories for
' damage
' sharp edges
' loose or missing parts
' rough surfaces

Fig. 16

Z Any inscriptions or identification necessary for the safe intended use must be
legible.
' To prevent wrong handling or reprocessing, any illegible lettering, labeling or
identification must be reinstated.
Z Check the BOA vision in the distal area for damage e.g. cracks on the outer
jacket / perforations.
Z Check for perfect condition, and replace if necessary
' Rubber cap (11)
' when using the biopsy valve cpl. (9): sealing valve, blue (9.2)
Z Check that the relevant technical data (diameter, working length, etc.) of endo­
scopic accessories and of BOA vision are the same.

. IMPORTANT!
For sterile products:
Sterility is only guaranteed if the packaging is undamaged and has not been
opened before.
' Do not use the product if the sterile packaging is damaged or the use-by date
has expired.
Z Check the sterile packaging of the universal sealing valve 1-6 Fr. (10).

GA-D396 19
8.2 Function check
Z Check the individual components for compatibility.
Z Check for secure connections.
Z Check for easy assembly and proper functioning of the locking mechanisms of
the individual products. Replace the products if the connection
' although locked is not secure.
' cannot be locked or is difficult to lock.
Z Check the deflection (angling) and the 0 position (snap in position) of the instru­
ment tip (4).
' See section 7.5.1

. NOTE!
The free passage (patency) of working channel and adapter is achieved by brush­
ing during manual cleaning.

8.2.1 Adapter (8) (option)

Fig. 17
Z Check that the stopcock plug (8.4.1) has positively engaged in stopcock hous­
8.4.1 ing (8.4.2).
Z Check the stopcocks (8.4) for leak-tightness.
8.4.2
' Turn the stopcock plug (8.4.1) to the closed position.
' In case of leaking stopcocks: Replace stopcock plug (8.4.2).
Z Check the stopcock plug (8.4.1) in the stopcock housing (8.4.2) for easy move­
ment.

Fig. 17

8.2.2 BOA vision

Z Check image quality and light output in conjunction with the system compo­
nents. For this purpose, please check whether the structure of a sterile com­
press is sharply displayed at a distance of 5 to 8 mm.
Fig. 18
Z Check the glass surfaces for any deposits.
' Deposits on the glass surfaces can cause a spotted or blurred field of view
and hence impair light transmission considerably.
Z Clean the glass surfaces on the URS with a cotton swab soaked with alcohol
(Isopropanol 70%) until no residues are visible on the glass surface.
Specification of the cotton swab:
- Solvent resistant
- Head of 100% pure cotton
- Wooden or plastic swab carrier, no metal swab carrier
- Head diameter 3­5 mm

Fig. 18

20 GA-D396
 Z Carry out a function check in conjunction camera controllers:
' LOGIC HD 552510x
- in accordance with instruction manual GA-A282
' LOGIC HD LITE 5525201
- in accordance with instruction manual GA-A293
' LOGIC 4K 5525301
- in accordance with instruction manual GA-A336
Z Check the function keys (15).

GA-D396 21
8.3 Carrying out a manual leakage test

. IMPORTANT!
Carry out a leakage test immediately after each use or each time before repro­
cessing.
Carry out the manual leakage test under dry conditions. Otherwise humidity may
enter inside the URS and cause damage.
Fig. 19
Z After disconnecting the camera plug (14.1) from the camera controller, firmly
14.2 14.1 installing the plug protection cap (14.2) fully onto the camera plug.
' see section 7.3

Fig. 19

Z Connect the tube with the twist-lock valve (c) to the pressure gauge.
Fig. 20
Z Connect the leak tester (REF # 163.903) to the connection for leakage test and
pressure equalization (12).
' Place the twist-lock valve (c) as far as it will go onto the connection for leak­
age test and pressure equalization (12) and lock by means of the twist-lock
mechanism.
Z Close the knurled screw (d).
Z Inflate the BOA vision to a pressure of 200 mmHg (±10 mmHg) using the pneu­
matic bulb.
' An initial pressure drop is caused by the expansion of the elastic tubes/hoses.
If the pressure reading is constant, the URS is leaktight.
' The BOA vision leaks if the initial pressure drop due to the elasticity of the
tubes/hoses will not come to a standstill after approx. 30 seconds (i.e. if there
is a constant pressure drop).
In this case please return the flexible endoscope to RICHARD WOLF for re­
pair.
Z Open the knurled screw (d) and depressurize.

. IMPORTANT!
After opening the knurled screw wait 20 seconds before you remove the leak tester.
This guarantees complete pressure equalization.

163.903 (c)

12
(d)

Fig. 20

22 GA-D396
9 Processing and maintenance
WARNING!
Unsterile use of products can transmit diseases!
The products are delivered unsterilized. To protect the patient, user and third
parties, the products must be processed in accordance with the manual
' prior the initial use
' before each subsequent use
' before return shipment
Informations regarding the processing of the accessories
' see chapter 9.7

9.1 Flowchart of the processing process „BOA vision“

Initial treatment A B
at the point of use

Assembly
Visual check
Transport Pressure equalization valve

Preparation Packaging
before cleaning

Labelling
Manual leakage test Undamaged? no

yes
Disassembly Repair/scrap
Discard the single-use item

Maintenance Sterilization
Preparatory Low temperature procedure
measures

Function check Documentation

Manual cleaning

Manual rinsing Storage

o.k.? no

no
yes
Manual drying Repair/scrap

Provision
Visually check
for cleanliness
o.k.?
yes
B

A
Fig. 21

GA-D396 23
9.2 Auxiliary resources required

Designation Richard Wolf REF #

(product number)
' Lint-free disposable cloth -
' Cotton swab -
Specification:
- Solvent resistant
- Head of 100% pure cotton
- Wooden or plastic swab carrier, no metal swab
carrier
- Head diameter 3­5 mm
' Leak tester 163.903
' Basin W 400 mm L 600 mm 509.81
' Syringe 20 ml -
' Cleaning brush Ø 2 mm TL 1200 mm 7990001
(Single-use item)
' Double conical straight cleaning brush 7980002
(Single-use item)
' Cleaning brush 8691
(Single-use item)
' Water jet cleaning pistol 6199.00
For manual cleaning
' Cold tap water (Drinking water) -
Temperature: 16 °C/61 °F ±2 °C/4 °F
' Demineralized water -
Temperature: 20 °C/68 °F ±2 °C/4 °F
' Cleaning solution (e.g. 0.8% Cidezyme, ASP) -
' Sterile water -
For sterilization
' APTIMAX instrument tray PC13837 -
' Tray 8585035
' Pressure equalization valve 163.904

24 GA-D396
9.3 Channel connections

6 7

Fig. 22

Item Designation Cleaning brushes

1 Working channel 7990001

Cleaning brush Ø 2 mm TL 1200 mm
(Single-use item)
6 Irrigation connector 7980002
Double conical straight cleaning brush
(Single-use item)
6, 7 Luer fitting 8691
Cleaning brush (Single-use item)

9.4 Remove/discard products before processing

Z Remove the auxiliary instrument.
Z Remove all connections between the URS and the system components.

. IMPORTANT!
The following parts are intended for single use only and must be discarded after
use following the country-specific regulations:
' Sealing valve, blue (9.2)
' Universal sealing valve 1-6 Fr. (10)

GA-D396 25
9.5 Processing procedure

. IMPORTANT!
' If used as intended and following the manufacturer's instruction manual, it is
not necessary to limit the number of possible processing cycles.
' Careful and gentle handling of medical products during the entire processing
process has an essential influence on the service life of the products.
' Before returning defective products for repair, they must have been sub­
jected to the entire processing cycle.
' The user must ensure that the processing process including the resources,
materials and personnel are suitable to achieve the required results.
CAUTION!
High thermal load!
Temperatures above 60 °C/140 °F as well as steam or hot air sterilization are not
permissible for the URS!
To avoid damage, sterilize the URS only using a low temperature sterilization
procedure.

Endoscopes used in sterile body cavities e.g. Ureterorenoscopy, Nephroscopy

Step Manual processing
1 Manual cleaning
2 Sterilization

. NOTE!
Preparing of the cleaning solution according to the IFU of the chemical manufac­
turer.

. NOTE!
Use enzymatic or pH-neutral detergent.

. NOTE!
The processing and sterilization process for the following products is described in
section 9.7.1 and must be followed:
' Adapter (8)
' Biopsy valve cpl. (9)
' Luer sealing cap (6.1)
' Rubber cap (11)
These products can be sterilized using both the low temperature sterilization proce­
dure and a steam sterilization procedure.

. NOTE!
All cleaning steps must be carried out thoroughly.

26 GA-D396
9.5.1 Processing procedure „BOA vision“

Initial treatment at the point of use Immediately after use of the URS:
1. Remove the irrigation and drain tube from the adapter (8).
2. Wipe the outer surfaces with a lint-free disposable cloth.

. IMPORTANT!
To avoid wrinkling or folding over of the plastic outer coating apply
reduced pressure in the distal area of the flexible endoscope while
wiping or handling.
3. If the plastic outer jacket forms creases or folds back, immediately smooth it.
4. Rinse out the inner lumens with a 20 ml syringe filled with tap water
(repeat 3x).
' For precleaning, do not use any agents (e.g. aldehyde) or hot water
(> 40 C/104 °F) as this will bake residues to the surfaces.
5. Open the supply / drain stopcock (8.2) and instrument port stopcock (8.3).
' Processing the adapter (8): see section 9.7.1

8.2

8.3

Fig. 23

Transport To avoid damage to the products and contamination of the environment, safe
storage in a closed container is required.

Preparation before cleaning

Manual leakage test . IMPORTANT!
Carry out a leakage test immediately after each use or each time before
processing.
' see section 8.3 “Carrying out a manual leakage test”

Immediately after carrying out the leakage test:

1. Remove the hose with twist-lock valve (c) from the pressure gauge and URS.
2. Spray the pressure gauge and the pneumatic bulb with an EPA registered
surface disinfectant and wipe with a lint-free disposable cloth.

GA-D396 27
 Disassembly before cleaning 1. Pull locking ring (8.1) in direction of arrow as far as it will go and remove
Adapter (8) the adapter (8).
2. Remove the rubber cap (11).
3. Remove the luer sealing cap (6.1).
4. If the following is used:
Biopsy valve cpl. (9) ' Biopsy valve cpl. (9): Unscrew biopsy valve cpl. (9).
Processing of biopsy valve cpl. (9): see section 9.7.1
Universal sealing valve 1-6 Fr. (10) ' Universal sealing valve 1-6 Fr. (10): Unscrew and discard the universal
sealing valve 1-6 Fr. (10).

8
6.1

8.1
11
10

Fig. 24

28 GA-D396
 Preparatory measures
for manual processing
. IMPORTANT!
Supply cable (14) Immerse (cleaning) and sterilize the camera plug (14.1) only with the
plug protection cap (14.2) in place.

14.2
14.1 14

Fig. 25

However, if the camera plug (14.1) is visibly contaminated, or if the plug protec­
tion cap (14.2) was not attached immediately after removing the plug from the
camera controller, then perform the following preparatory processing steps:
1. Immerse the flexible endoscope with open camera plug (14.1) in an enzyma­
tic or pH-neutral cleaning solution [e.g. 0.8% solution of Cidezyme (ASP),
20 C/68 °F for 6 minutes] at room temperature.
' For the immersion time and the concentration to be used, please refer to
the manufacturer's specifications.
2. Rinse the camera plug (14.1) under cold tap water until no residues are
visible.
3. Dry carefully with compressed air e.g. pistol (e.g. Richard Wolf REF #
6199.00) until no moistness is visible (pressure 2.5-4 bar/36-58 psi).
' Residual moisture in the contacts can impair signal transmission (e.g.
interruptions, poor contacts).

. IMPORTANT!
In this case do not attach the plug protection cap (14.2) during steriliza­
tion.

GA-D396 29
 Manual cleaning CAUTION!
Droplet spray transmission of microorganisms!
To prevent spray contamination in the environment, always rinse out
the channels while the instrument is immersed in cleaning solution.
Follow the applicable staff protection guidelines.

. IMPORTANT!
Do not clean the URS in an ultrasonic bath!

. IMPORTANT!
Use only cleaning agents whose efficacy and material compatibility with
flexible endoscopes and endoscopic accessories has been verified and
approved.
For the concentration and exposure time of the cleaning agents used,
please refer to the chemical manufacturer's instructions.
Do not use care products as these cause deposits on the instrument and
can damage the plastic material.

. IMPORTANT!
Never use metal or sharp-edged tools (e.g. metal brushes) for manual
cleaning.

. IMPORTANT!
Do not attach the pressure equalization valve during cleaning.
' With the pressure equalization valve in place, liquid would enter
inside the endoscope and destroy internal components during
cleaning.

. IMPORTANT!
When using a water jet cleaning pistol/compressed air pistol, do not
exceed the following pressures:
' URS: maximum 1.5 bar/22 psi
' Spare parts and accessories: 2.5-4 bar/36-58 psi
- Adapter (8)
- Biopsy valve cpl. (9)
- Luer sealing cap (6.1)
- Rubber cap (11)

During the entire processing process the following must be observed:

Z Do not kink the flexible instrument sheath and do not bend to an excessively
narrow radius (minimum 150 mm diameter).
Z The brake (toggle lever) on the control lever for locking the instrument tip in
an angled position must be released.
' see section 7.5.1
Z Reduced pressure in the distal area of the flexible endoscope while wiping or
handling.
Z If the plastic outer jacket forms creases or folds back, immediately smooth it.
Z Carefully take the URS out of the cleaning solution by hand to avoid any
damage.
' Do not use instrument forceps.

30 GA-D396
 Working channel (1) 1. To remove any clogging and residues, rinse out the channels with a 20 ml
syringe filled with 20 ml of the cleaning solution.
' Irrigation connector (6) - (repeat 1x)
' Working channel (1) - (repeat 4x)
For this, close the irrigation connector (6) with your finger.

1x 4x
1

Fig. 26

2. Immerse completely in a washbasin (e.g. Richard Wolf REF # 509.81 filled

with 3 gallons) of cleaning solution [e.g. 0.8% solution of Cidezyme (ASP),
20 C/68 °F for 6 minutes] at room temperature.
' For the immersion time and the concentration to be used, please refer to
the manufacturer's specifications.
3. Fill the working channel (1) with this cleaning solution.
' For filling we recommend using a 20 ml syringe.
4. Use a cleaning brush (REF # 7980002) to brush the luer fittings (6) (7) until
any visible residues have been removed (6 brush strokes).
Luer fittings (6) (7)

7980002 6x

6 7
1

Fig. 27

GA-D396 31
 5. Then brush the channel with disposable (single-use) cleaning brush
(REF # 7990001). Pass the single-use cleaning brush with its brushless
end only from proximal to distal end through the working channel (1)
without using force.
6. Pull the single-use cleaning brush completely through the working channel (1)
only in direction of arrow as shown in Fig. 28 (repeat 6x).

. IMPORTANT!
Do not push and pull back and forth the single-use cleaning brush in the
working channel as this can cause damage.
Working channel (1)
6x 7990001

Fig. 28

7. Clean the outer surfaces of handle and luer fittings with a cleaning brush
(REF # 8691) until any visible residues have been removed.
Handl and luer fitting (6) (7)
8691

6 7

Fig. 29

8. Rinse by immersing in a washbasin (e.g. Richard Wolf REF # 509.81 filled

with 3 gallons) of demineralised water for 5 minutes at room temperature.
While immersed in the water, flush the channels using a 20 ml syringe filled
with 20 ml of the demineralized water (repeat 4x).

32 GA-D396
 Manual drying 1. Then dry the working channel (1) until the air coming out is dry:
' with filtered compressed air (at a reduced pressure of max. 1.5 bar/22 psi)
or
' with a dry 20 ml syringe filled with ambient air
' rinse out with alcohol (Isopropanol 70%) and remove the alcohol with a
dry 20 ml syringe filled with ambient air
2. Dry the outer surface with a lint-free disposable cloth or cotton swab.

Fig. 30

Function check Check visually for cleanliness. If necessary, repeat the processing procedure
Visual check until the product is visually clean.
Maintenance ' Carry out a visual and functional check: see sections 8.1 and 8.2
Assembly before sterilization Attaching the pressure equalization valve (REF # 163.904).

. IMPORTANT!
During low temperature sterilization using hydrogen peroxide with and
without plasma and gas the pressure equalization valve must be placed
onto the connector for leakage test and pressure equalization.
All connectors must be dry.
1. Dry the connectors with a lint-free disposable cloth.
2. Place the pressure equalization valve (REF # 163.904) onto the connector
for leakage test and pressure equalization (12) as far as it will go and lock
the twist-lock mechanism.

. IMPORTANT!
Use the pressure equalization valve only during the low temperature
sterilization procedures hydrogen peroxide and ethylene oxide gas.
3. Remove the pressure equalization valve (REF # 163.904) before use.

163.904 12

Fig. 31

GA-D396 33
 Packaging Package the endoscope according to standards in a sterilization container
(e.g. REF # 8585035) approved for the selected sterilization method. When
positioning the flexible scope in the container, do not bend the scope sheath
in a tight radius (150 mm diameter minimum).
To sterilize the product, use a packaging that has been approved for the applied
sterilization procedure and validated for the process used (e.g. single wrap with
Tyvek packaging material).
Wrap the product, for sterilization in sterilization package according ANSI/AAMI/
ISO 11607-1.

Sterilization
Sterilization procedure
. IMPORTANT!
By no means must these low temperature procedures be used alter­
nately. Possible interaction between these sterilization procedures can
damage the products.
Sterilize the URS with the following low temperature sterilization procedures
taking into account the national requirements of your country.

Sensor-Ureterorenoscope BOA vision

STERIS
STERRAD NX STERRAD 100 NX
V-PRO maX
Sterilization
container: Advanced Cycle Flex Cycle Flexible Cycle
APTIMAX   X
Tray 8585035   

 = recommended  = allowed X = not allowed

Storage Store the sterilized instruments in accordance with ANSI/AAMI ST91.

34 GA-D396
9.6 Flowchart of the processing process „Accessories“

Initial treatment A B
at the point of use

Visual check Labelling

Transport

Preparation Documentation
before cleaning

Storage
Disassembly Undamaged? no

yes
Repair/scrap
Manual cleaning

Maintenance Provision
Manual rinsing
no
Function check
Manual drying

o.k.? no
Visually check
for cleanliness
o.k.? yes
Repair/scrap
yes

A
Assembly

Sterilization?
Low temperature procedure no

yes
Steamsterilization

Packaging

B
Fig. 32

GA-D396 35
9.7 Auxiliary resources required
Designation Richard Wolf REF #
(product number)
' Basin W 400 mm L 600 mm 509.81
' Syringe 20 ml -
' Double conical straight cleaning brush 7980002
(Single-use item)
' Cleaning brush 8691
(Single-use item)
' Water jet cleaning pistol 6199.00
For manual cleaning
' Cold tap water (Drinking water) -
Temperature: 16 °C/60 °F ±2 °C/4 °F
' Demineralized water -
Temperature: 20 °C/68 °F ±2 °C/4 °F
' Cleaning solution (e.g. 0.8% Cidezyme, ASP) -
For sterilization
' APTIMAX instrument tray PC13837 -
' Tray 8585035

36 GA-D396
9.7.1 Processing procedure „Accessories“

Initial treatment at the point of use 1. Wipe the outer surfaces with a lint-free disposable cloth.
Adapter (8) 2. Close the supply and drain stopcock (8.2), open the insertion port stopcock
(8.3).
3. Rinse out the channels with a 20 ml syringe filled tap water - (repeat 3x).
' For precleaning, do not use any agents (e.g. aldehydes) or hot water
(> 40 °C/104 °F) as this will bake residues to the surfaces.

8.3
3x
8.2

Fig. 33

4. Close the insertion port stopcock (8.3) open the supply and drain stopcocks
(8.2).
5. Rinse out with a 20 ml syringe filled with tap water - (repeat 3x).

8.3
8.2

3x

Fig. 34

Transport To avoid damage to the products and contamination of the environment, safe
storage in a closed container is required.

GA-D396 37
 Preparation before cleaning
Disassembly Z Remove the stopcock plug (8.4.1) in direction of arrow.
Adapter (8) ' Stopcock plug (8.4.1) disengages from the stopcock housing (8.4.2).
Biopsy valve cpl. (9)
. NOTE!
Replace the sealing valve, blue (9.2) (single-use item) after each use.
1. Unscrew the valve cap (9.3).
2. Remove the sealing valve, blue (9.2) and discard.

9.2 9.3
8.4.1

8.4.2

Fig. 35

Manual cleaning 1. Immerse the products in a washbasin (e.g. Richard Wolf REF # 509.81 filled
with 3 gallons) including the new single-use items [sealing valve, blue (9.2)]
in a cleaning solution (e.g. 0.8% solution of Cidezyme (ASP), 20 C/68° F for
6 minutes) at room temperature.
' For the immersion time and the concentration to be used, please refer to
the manufacturer's specifications.
2. Brush the inner surfaces with a cleaning brush (REF # 7980002) until no visi­
ble soiling remains (6 brush strokes).
3. Clean the outside surfaces with a cleaning brush (REF # 8691) until no visible
soiling remains (6 brush strokes).
4. Rinse by immersing the products in a washbasin (e.g. Richard Wolf REF #
509.81 filled with 3 gallons) of demineralized water for 5 minutes at room
temperature.
' Rinse each channel with a water jet cleaning pistol (e.g. Richard Wolf
REF # 6199.00) with 5 pressure surges (each pulse 4 seconds) with 2.5 -
4 bar (36 - 38 psi)

6x 7980002
6x

7980002
6x
6x 7980002
7980002
6x

8691

6x
Fig. 36

38 GA-D396
 Manual drying 1. Dry the outer surfaces of the products using a lint-free disposable cloth or
swab or with filtered compressed air (2.5-4 bar/36-58 psi).
2. Dry the channels with filtered compressed air in pulsed mode applying
5 pressure surges (2.5-4 bar/36-58 psi) or with a dry 20 ml syringe
filled with ambient air.

Function check Check visually for cleanliness. If necessary, repeat the Processing procedure
Visual check until the product is visually clean.
Maintenance ' Carry out a visual and functional check: see sections 8.1

Assembly before sterilization

. NOTE!
Before sterilization, screw on the screw connections only loosely in order
' to allow a sufficient flow of the sterilization medium.
' to prevent stress cracks.
Tighten all screw connections before use.

Adapter (8) 1. Insert the stopcock plug (8.4.1) into the stopcock housing (8.4.2).
' The stopcock plug (8.4.1) engages noticeably.
2. Open the stopcock plug (8.4.1).
Biopsy valve cpl. (9) 3. Install the cleaned new sealing valve, blue (9.2) (single-use item) in the
valve housing (9.1).

8.4.1

9.1 9.2 9.3

8.4.2

Fig. 37

Packaging Wrap the product, for sterilization in sterilization package according ANSI/AAMI/
ISO 11607-1.

Sterilization Use only moist heat/steam sterilization on a dynamic air-removal-cycle with

Sterilization procedure 3 vacuum pulses.
' Temperature exposure time: 4 min at 132 C/270 F
' Drying time: 35 min
The drying time depends on the sterilization process used.

. NOTE!
The following products can also be sterilized by low temperature sterili-
zation procedure as described on page 34:
' Adapter (8)
' Biopsy valve cpl. (9)
' Luer sealing cap (6.1)
' Rubber cap (11)

Storage Store the sterilized instruments in a restricted area at approximately 24 °C/

75 °F, with 4 air exchanges per hour and a relative humidity that does not
exceed 70%, in accordance ANSI/AAMI ST79.

Assembly before use Z Screw on the valve cap (9.3): see chapter 7.2.2

GA-D396 39
9.8 Processing in case of repair
CAUTION!
In order to protect the service personnel and for safety reasons during transport
and shipment, all flexible scopes returned for repair must be fully cleaned and
sterilized before transport to Richard Wolf for repair.
Richard Wolf reserves the right to charge the sender if the returned device is
visibly soiled.

Return for repair Follow these instructions for preparing the flexible endoscope to be returned
for repair:
1. Clean and sterilize the scope.
2. Return the flexible scope in the transport case that was used to deliver the
scope to the facility.
3. Wrap the scope completely in either a tubular plastic bag with plastic clos­
ure or in protective plastic sheeting (for flexible endoscopes, e.g. Richard
Wolf REF # 155831218). Carefully position the wrapped scope in the
transport case.
4. Include in the transport case documentation that the scope has been repro-
cessed.

40 GA-D396
10 Technical data and order data
Working
channel /
Sensor- Working Outside Inner diameter Angle of Direction of
Uretero­ Product no. length diameter [mm / Fr.] view view
renoscope [mm] [Fr.] [] []
Length
[mm]

1.2 / 3.6
7355071,
BOA vision 7355071US 680 8.7 90 6.5
830

1.2 / 3.6
7355076,
BOA vision 680 8.7 90 6.5
7355076US 830

11 Spare parts and accessories

Item Illustration Product no. Designation

Adapter
8 7305.782 (option)
(Reusable, must be processed before use)

Rubber cap cap 0.8mm

RIWO
11 88.01 color: red
passage 0.8 mm (7 Fr.), pack=10 pcs
(Reusable, must be processed before use)
Stopcock bndl cap 3.0mm
8.4.1 896.0002
(Reusable, must be processed before use)
Biopsy valve bndl
9 7265.8512 (option)
consisting of:

9.1 Biopsy valve holder

7265.851 for flexible endoscopes with instrument channel
9.3
(Reusable, must be processed before use)
Sealing valve, blue (pack=20 pcs)
9.2 15114068
(Single-use item, must be processed before use)
Luer sealing cap
6.1 15023205
(Reusable, must be processed before use)

Leak tester for flex. endoscopes

- 163.903
(Reuseable item)

Pressure equalization valve

for low-temperature sterilization procedure with
- 163.904 - hydrogen peroxide H2O2 and
- ethylene oxide gas (EO)
(Reuseable item)
Universal sealing valve 1-6 Fr
(option)
10 4712348
for inserting auxiliary instruments of 1-6 Fr, pack=5 pcs
(Single-use item, is provided sterile)

GA-D396 41
 Item Illustration Product no. Designation

Uro flex endoscope tray plastic

Sterilization tray for digital flexible endoscopes
plastic molded tray with two small-part compartments
- 8585035
Use for reprocessing in STERRAD or V-PRO
21.3“ L x 10“ W x 3“ H
(Reuseable item)

Disinfection basin W 400mm L 600mm

for disinfection,
- 509.81 not steam-sterilizable
incl. lid without sieve basket
(Reuseable item)

Water jet cleaning pistol

- 6199.00
(Reuseable item)

Flex. grasp. forceps 3Fr WL 920mm

- 828.651
(Reusable, must be processed before use)

Flex. biopsy forceps 3Fr WL 920mm

- 829.601
(Reusable, must be processed before use)

Cleaning brush Ø 2mm TL 1200mm

for flexible endoscopes for channel Ø 1.0-1.5 mm
brush length 15 mm, PACK = 10 PCS, color: yellow,
- 7990001 (Single-use item)

Double conical straight cleaning brush

for stopcock inserts / housings with 3 pegs,
- 7980002 brush head 1: conical Ø 5-9 mm, brush head 2: Ø 4 mm
PACK = 50 PCS, color: red,
(Single-use item)

Cleaning brush
- 8691 for surface cleaning, straight, PACK = 10 PCS,
(Single-use item)

- - 155831218 Foil for shipment of flexible endoscopes

The products can be combined as required provided the relevant technical data and intended uses are observed. For
a general overview please refer to the latest catalog pages, brochures or contact Richard Wolf or your representative.

. NOTE!
The supply cable (14) is a wear and tear part and therefore excluded from warranty.

42 GA-D396
12 Operating, storage, transport and shipping conditions
Temperature: +10 ºC/+50 °F to +40 ºC/+104 °F,
Operating conditions rel. humidity: 20% to 75%,
atmospheric pressure: 700 hPa to 1060 hPa

Temperature: -20 ºC/-4 °F to +60 ºC/+140 °F,

Storage, transport and shipping
rel. humidity: 10% to 90%,
conditions
atmospheric pressure: 700 hPa to 1060 hPa

Disposable items, steril

Follow instructions on package!
products

. IMPORTANT!
Store sterile products in the original packaging until use.
Incorrect storage may lead to loss of sterility.

. NOTE!
To prevent damage during transport or shipment of the products we recommend
using the original packaging material.
12.1 Disposal of product, packaging material and accessories
For the disposal observe the relevant regulations and laws valid in your country.
' For further information please contact the manufacturer.

GA-D396 43
13 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.

44 GA-D396