Storz HOPKINS User manual

Telescopes
Instruction
anual
HOPKINS
®

2
Important information for
us rs of KARL STORZ
instrum nts
Thank you for placing confidence in the
name of KARL STORZ. As with all our
other products, we have invested years of
experience and much care in production
of this telescope. You, and your organi-
zation, have chosen a modern high-quality
KARL STORZ instrument.
These instructions are designed to assist
you in cleaning, sterilizing, disinfecting,
caring for and storing your KARL STORZ
telescopes. Please read them carefully.
CAUTION: Federal (USA) law restricts
this device to sale by or on the order of a
physician.

3
Illustrat d D scription
Specifications:
Letter Code Direction of View
A 0°-10° Straight Forward
B 30° Forward-Oblique
C 70° Lateral
D 90° Lateral
120° Retrospective
F 45°
W 30° Wide Angle
FA 12° Telescopes
KARL STORZ HOPKINS®and HOPKINS®
II Telescopes are provided both auto-
clavable and non-autoclavable. To iden-
tify the difference please note “AUTO-
CLAV” marked on the eyepiece.

4
Cont nts
Illustrative Description..........................3
Important Information...........................5
General Information for the Safe Use of
KARL STORZ Telescopes ....................7
Inspection ..........................................10
Handling.............................................12
Operating Instructions .......................13
Cleaning, Disinfection and
Sterilization.........................................15
Manual Cleaning ................................16
Automated Washing...........................18
Inspection ..........................................19
Disinfection Instructions.....................20
Sterilization Instructions .....................24
Inspection Upon Receipt ...................30
Maintenance and Repair....................30
Return Policy ......................................31
Warranty Policy ..................................34
Limitation of Liability...........................36
Appendix I..........................................38
A. Indications and Contraindications
for Urology ................................38
B. Indications for General Surgery38
C. Indications for Thoracoscopy ...38
D. Indications for ar, Nose
and Throat.................................39
. Indications for Arthroscopy.......40
F. Indications for Plastic Surgery ..40
G. Indications and Contraindications
for Gynecology .........................41

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H. Indications and Contraindications
Diagnostic Hysteroscopy..........43
I. Indications and Contraindications
Operative Hysteroscopy ...........44
J. Indications & Contraindications
for Neurology ............................47
K. Indications & Contraindications
for Dentistry...............................49
Appendix II.........................................50
A. Cleaning Accessories...............50
Important Information for us rs
of KARL STORZ instrum nts
I PORTANT
Please read this entire manual carefully
before using KARL STORZ HOPKINS®
and HOPKINS®II Telescopes. Failure to
follow the instructions, cautions and warn-
ings presented in this manual may result
in serious consequences to the patient.
The procedures for proper handling and
care of KARL STORZ HOPKINS®and
HOPKINS®II Telescopes are described
in this manual. The KARL STORZ HOPKINS®
and HOPKINS®II Telescopes are delicate
optical instruments and should be handled
with care. Improper use during surgical
procedures will result in damage or
breakage of the telescope. KARL STORZ
ndoscopy-America, Inc. assumes no
liability if the telescopes are misused,
mishandled or otherwise abused.

6
Proper handling and care, as described
in this manual, will prolong the life of the
KARL STORZ HOPKINS®and HOPKINS®
II Telescopes.
Recommended procedures for inspecting
and preparing the telescopes for use are
described in this manual. The manual
does not describe how the actual proce-
dure is to be performed. ndoscopic
procedures should be performed only by
physicians who have training in endo-
scopic techniques. Consult medical liter-
ature relative to techniques, complications
and hazards of endoscopic procedures.
A thorough understanding of the principles
and techniques involved in endoscopic
and electrosurgical procedures is essential
to avoid shock and burn hazards to both
the patient and physician.
The KARL STORZ HOPKINS®and HOP-
KINS®II Telescopes are compatible with
any light sources and light cables marketed
by KARL STORZ ndoscopy America, Inc.
CAUTION: The KARL STORZ HOPKINS®
and HOPKINS®II Telescopes are provided
NON-ST RIL , and must be cleaned,
disinfected and/or sterilized prior to the
initial use and before each subsequent
use.

7
G n ral Information for th
Saf Us of KARL STORZ
T l scop s
User qualifications
These instruments may only be used by
licensed physicians and qualified medical
personnel who have been trained in their
use.
Warnings and precautions
Please read this manual carefully. It is
very important that the user be thoroughly
familiar with the operation of the instrument
prior to use on a patient. The terms “Warn-
ing,” “Caution” and “Note” are intended
to draw your attention to important parts
of the instruction manual. All warnings,
precautions and notes should be thoroughly
reviewed prior to use of the instrument.
Close attention to all warnings, precautions
and notes is necessary for safe and effective
operation of the device.
Definitions
WARNING: A warning indicates that
the personal safety of the patient or physi-
cian may be compromised. Disregarding
the warning may result in serious injury
to the patient or the physician.
CAUTION: A caution indicates that the
device may be damaged if the caution is
disregarded.

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G n ral Information for th
Saf Us of KARL STORZ
T l scop s (Continu d)
Not : A note provides additional infor-
mation regarding the safe operation of
the device.
Description of Device
The KARL STORZ HOPKINS®and HOP-
KINS®II telescopes are reusable rod lens
endoscopes consisting of an eyepiece
lens, a light post connection for fiber
optic light cables with screw-on adapters
which will accommodate light cables from
other manufacturers. A shaft made of non-
corrosive material encloses the rod-lens
system and a built-in fiber optic light car-
rier. See page 3 for identification of parts.
Indications
KARL STORZ HOPKINS®and HOPKINS®
II telescopes are to be used for visuali-
zation of the surgical site during diagnostic
and therapeutic endoscopic procedures.
See Appendix I for specific indications
for use.
Contraindications
KARL STORZ HOPKINS®and HOPKINS®
II telescopes are contraindicated for use
when, in the opinion of a qualified physician,
such use would create a condition that
would be dangerous for the patient. See
Appendix I for specific contraindications.

9
WARNING: KARL STORZ HOPKINS®
and HOPKINS®II telescopes are provided
NONSTERILE and must be thoroughly
cleaned and sterilized according to
validated infection control procedures
prior to use and subsequent reuse.
WARNING: High level disinfection is
recommended ONLY for telescopes
which come into contact with intact
mucous membranes or minor skin
breaches. Disinfection is NOT recom-
mended for telescopes to be used for
laparoscopic, arthroscopic, hystero-
scopic, Ob/Gyn, plastic, reconstructive,
aesthetic, or neurology surgery proce-
dures.
WARNING: Always adjust the light
source to the minimum illumination
intensity necessary to achieve optimum
illumination of the endoscopic scene,
either by direct vision or coupled to a
video camera. The higher the light
intensity setting of the light source,
the greater the heat energy that will be
generated at the distal end of the tele-
scope.
WARNING: Never place the end of a
fiber optic cable or telescope connected
to a light cable on or under a surgical
drape while the light source is activated.
The intensity of the light may cause
burns to the patient and/or the surgical
drape. Turn the light source to standby

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G n ral Information for th
Saf Us of KARL STORZ
T l scop s (Continu d)
or initial mode when the telescope is
not in use. Never attach cable or cable
connector to patient or drape.
WARNING: Do not use telescopes
with visible signs of damage.
CAUTION: Steam sterilize only KARL
STORZ telescopes marked 'AUTOCLAV'!
Non-autoclavable telescopes will suffer
irreparable damage.
CAUTION: Do not use Immediate-Use
Steam (FLASH) sterilization for any KARL
STORZ HOPKINS®or HOPKINS®II tele-
scopes.
Insp ction
Inspection of the HOPKINS®and
HOPKINS®II Telescopes: Inspection
of the KARL STORZ HOPKINS®and
HOPKINS®II Telescopes for signs of
damage should be performed before
and after every surgical procedure.
Working Shaft
Inspect the entire surface of the working
shaft of the telescope for any signs of
damage such as dents, bends or scratch-
es.

11
Objective Lens and Eyepiece
Inspect the objective lens (distal tip) and
eyepiece for scratches, chips, fingerprints
or residual debris by observing the reflected
light on the surfaces of the eyepiece and
objective lens. These surfaces should
be smooth and shiny. To check for clarity
of view slowly rotate the telescope while
looking through the eyepiece. A partially
or completely obstructed view may be
the result of a damaged lens within the
eyepiece or within the telescope shaft.
Foggy images may result from moisture
entering a damaged seal around the lens.
CAUTION: Do not use telescopes if signs
of damage are present.
CAUTION: The telescope must be re-
placed if the image is clouded, distorted
or there is no image.
CAUTION: The telescopes are provided
NON-ST RIL and must be cleaned, dis-
infected and/or sterilized prior to initial
use and subsequent reuse.
CAUTION: Steam sterilize only KARL
STORZ telescopes marked 'AUTOCLAV'!
Non-autoclavable telescopes will suffer
irreparable damage.
CAUTION: Do not use Immediate-Use
Steam (FLASH) sterilization for any KARL
STORZ HOPKINS®and HOPKINS®II tel-
escopes.

12
Insp ction (Continu d)
If there is any doubt about whether the
telescopes are safe to use, please contact
your sales representative or the Technical
Support Staff directly at KS A (1-800-
421-0837).
Handling of HOPKINS®and
HOPKINS®II T l scop s
KARL STORZ HOPKINS®and HOPKINS®
II Telescopes are delicate instruments.
To ensure the long lasting quality of the
telescope, please follow the handling
instructions described below.
1. To prevent breakage, telescopes
should be supported by firmly grasp-
ing the eyepiece end. Never handle
the telescope by the distal end alone.
2. Never bend the stainless steel shaft.
This could lead to breaks or cracks
in the rod-lens system.
3. Handle the telescope with care. Mis-
handling of the telescope, particularly
at the distal end, may result in damage
or cracks in the telescope. Damage
to the telescope may allow liquid and
other materials to penetrate causing
unclear images.
4. When cleaning, disinfecting and ster-
ilizing telescopes, KARL STORZ
recommends that they be handled
separately from other instruments.

13
5. Trays and containers, which are suit-
able for storage, transport and ster-
ilization, are available in various
lengths for KARL STORZ HOPKINS®
and HOPKINS®II Telescopes.
Op rating Instructions
1. Be sure that the telescopes have
been properly cleaned, disinfected
and/or sterilized prior to use. (See
Cleaning, Disinfection and Sterilization
section for detailed procedures).
2. Inspect the telescope for damage
and proper function as described
above.
3. Operate all video and light source
equipment in accordance with man-
ufacturer’s instructions.
WARNING: Always adjust the light
source to the minimum illumination
intensity necessary to achieve optimum
illumination of the endoscopic scene,
either by direct vision or coupled to a
video camera. The higher the light
intensity setting of the light source,
the greater the heat energy that will be
generated at the distal end of the tele-
scope.

14
Op rating Instructions
(Continu d)
WARNING: Never place the end of a
fiber optic light cable or a telescope
connected to a light cable on or under
a surgical drape while the light source
is activated. The intensity of the light
may cause burns to the patient and/or
the surgical drape. Turn the light source
to standby or initial mode when the
telescope is not in use.
4. Prepare the surgery entry site in ac-
cordance with proper endoscopic
surgical techniques. Consult the ap-
propriate medical literature.
5. Attach the light cable to the fiber
optic light post on the telescope.
KARL STORZ recommends that the
appropriate size light cable be used
to minimize the heat energy gener-
ated from the light source. Use of
the appropriate size light cable will
reduce the risk of patient burns, as
well as the risk of igniting flammable
material.
Telescope Diameter Light Cable Diameter
4.0 mm and less 2.5 mm
6.0 mm and less 3.5 mm
Larger then 6.0 mm 4.8 mm

15
Cl aning, Disinf ction and
St rilization Instructions:
WARNING: The KARL STORZ HOP-
KINS®and HOPKINS®II Telescopes
should be thoroughly cleaned, disin-
fected and/or sterilized according to
validated infection control procedures
prior to use and subsequent reuse.
CAUTION: DO NOT soak the telescope
in any solution (including water) for longer
than 60 minutes.
Water Quality Requirements
Utility Water:
Water as it comes from the tap that meets
the specifications as defined by AAMI
TIR 34: Water for Reprocessing of Medical
Devices
Critical Water:
Water that is extensively treated (usually
by a multistep treatment process that
could include a carbon bed, softening,
DI and RO, or distillation) to ensure that
the microorganisms and the inorganic
and organic material are removed from
the water; a final submicron filtration
could also be part of the treatment
process.

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Cl aning, Disinf ction and
St rilization (Continu d):
WARNING: Endoscopes must be high-
level disinfected or sterilized after man-
ual washing or automated washing.
Pre-Cleaning (at point-of-use)
1. Disconnect the light cable and cam-
era (if used) from the telescope.
2. Immediately after a procedure, at
the point of use (e.g. operating room),
wipe the telescope with a soft, lint-
free, disposable cloth moistened with
water or a diluted mild/neutral pH
enzymatic cleaning solution to remove
all heavy soiling.
3. Contain and transport the contami-
nated telescope to the decontami-
nation area for cleaning.
4. If immediate cleaning is not feasible,
place the endoscope in a container
and soak in a neutral/mild pH enzy-
matic cleaning solution (e.g. nzol),
diluted to proper concentration per
manufacturer's instructions.
Manual Cl aning for HOPKINS®
and HOPKINS®II T l scop s
CAUTION: W AR PROT CTIV GLOV S,
CLOTHING AND A FAC MASK FOR
CL ANING OF CONTAMINAT D T L -
SCOP S.

17
CAUTION: DO NOT clean the KARL
STORZ HOPKINS®and HOPKINS®II Tel-
escopes in an ultrasonic bath.
1. Remove light cable adapters before
cleaning. Do not clean or rinse tele-
scopes with other instruments to pre-
vent damage to the telescope.
2. Thoroughly rinse the endoscope for
a minimum of 2 minutes with water
to remove all gross debris.
3. Completely immerse the endoscope
in a diluted neutral/mild pH enzymatic
cleaning solution (e.g. nzol). Keep
immersed for a minimum of 5 min-
utes.
4. While immersed, brush all surfaces
of the endoscope with a soft bristle
brush. Do not brush the glass window
of the device but wipe carefully using
a lint-free, soft cloth. Rinse the bristles
of the brush with water if heavy debris
collects on it. Keep brushing until
there is no visible debris on the bristle
of the brush (minimum of 2 minutes).
5. Using a channel brush, brush all
channels until there is no visible
debris on the bristles of the brush
(minimum of 3 passes).
6. Flush all channels with a minimum
of 10 mL of cleaning solution.

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Manual Cl aning (Continu d):
7. After the immersion period, remove
the endoscope from the cleaning so-
lution and completely immerse in a
large volume of room temperature
water. Gently agitate the device while
immersed and keep immersed for a
minimum of 1 minute. Flush all chan-
nels with a minimum of 10 mL of
water. Discard the water and repeat
two more times with fresh water for a
total of 3 immersion rinses.
8. Dry the endoscope with a soft, lint-
free cloth or clean, dry, oil-free com-
pressed air (<5 psi).
9. Dry all channels with clean, dry, oil-
free compressed air.
10. Continue to the Inspection Section.
Automat d Washing
WARNING: DO NOT process HOPKINS®
telescopes with channels through an
automated washer-disinfector.
WARNING: The telescope must still
be sterilized or high-level disinfected
after processing through the washer-
disinfector.
anual Pre-Cleaning
1. Thoroughly rinse the telescope for a
minimum of 2 minutes under running
water to remove all gross debris.

19
Automated Cleaning
1. Place the telescope in a compatible
tray (P/N 39305 C1S/C2S/L1S/L2S).
2. Process in the washer-disinfector with
the following minimum cycle param-
eters:
Insp ction
1. After cleaning, inspect the endoscope
and light cable for cleanliness and
damage. If visible debris is observed,
repeat the cleaning steps. Do not
use the endoscope if visible signs of
damage are observed.
Cycle Phase Cycle Parameter
Pre-Wash 1 1 minute, cold water
Pre-Wash 2 1 minute, cold water
Wash 1
6 minutes, 55˚C,
alkaline cleaning
detergent (e.g.
Neodisher Septoclean)
Rinse 1 minute, cold water
Thermal Rinse 5 minutes, 90˚C
Drying 10 minutes

20
2. Inspect the endoscope for any visible
signs of damage (cuts, dents, or
scratches) that may trap residual debris.
Do not use the endoscope if it is dam-
aged or is difficult to use. The endo-
scope should be returned to KARL
STORZ for repairs or replacement.
High L v l Disinf ction
Instructions for KARL STORZ
T l scop s
WARNING: High level disinfection is
recommended ONLY for telescopes
which come into contact with mucous
membranes or minor skin breaches.
Disinfection is NOT recommended for
telescopes to be used in any laparo-
scopic, arthroscopic, OB/GYN, plastic,
reconstructive, aesthetic, or neurology
surgical procedures.
CAUTION: Before disinfection, the instru-
ments must be thoroughly cleaned, rinsed,
and dried.
CAUTION: To avoid damage to the instru-
ments, do not immerse the devices in dis-
infectant solution for longer than one hour.
KARL STORZ HOPKINS®and HOPKINS®
II Telescopes may be chemically disin-
fected using high-level disinfectant solu-
tions containing a 2.4% concentration of
glutaraldehyde (e.g. CID X®, a 14-day
glutaraldehyde solution) or 0.55% ortho-
phthalaldehyde (e.g. CID X® OPA, a 14-
day solution).