Karl Storz IMAGE 1 S H3-Z FI User manual

KARL STORZ
IMAGE 1 S
H3-Z FI
Camera Head
Instruction Manual
CAUTION: Federal (USA) law restricts
this device to sale by or on the order of a
licensed physician.

Contents
General Information .................................4
Illustrated Description...............................6
Operating Instructions ..............................6
Cleaning, Disinfection and Sterilization....9
Pre-Cleaning.............................................9
Manual Cleaning.....................................10
Sterilization Instructions..........................11
Terms and Conditions ............................13
Shipping .................................................13
Return Policy...........................................13
Inspection, Preventative Maintenance and
Other Services ........................................15
Training .................................................15
Repair Program ......................................15
Warranty Policy.......................................16
Limitation of Liability ...............................17
Software Ownership and Licensing .......18
3

General Information
Thank you for your expression of confidence
in the KARL STORZ brand name. Like all of
our other products, this product is the result
of years of experience and great care in
manufacture. You and your organization
have decided in favor of a modern, high-
quality item of equipment from KARL
STORZ.
This instruction manual is intended to serve
as an aid in the proper handling, cleaning,
disinfection and sterilization of your instru-
ments. All essential details of the equipment
and all actions required on your part are
clearly presented and explained. We thus
ask that you read this manual carefully before
proceeding to work with the instrument. Keep
this manual available for ready reference.
Intended Use
The KARL STORZ IMAGE 1 S 3-Z FI Camera
ead is intended for use with the KARL
STORZ ICG Imaging System for real-time
endoscopic visible and near-infrared fluo-
rescence imaging.
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 “Warning,”
“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.
4

5
Definitions
WARNING: A warning indicates that the
personal safety of the patient or physician
may be compromised. Disregarding the
warning may result in serious injury to the
patient or the physician.
Ca tion: A caution indicates that the
device may be damaged if the caution is
disregarded.
Note: A note provides additional information
regarding the safe operation of the device.
This instruction manual is intended to serve
only as a supplement to the KARL STORZ
video systems instruction manual. To ensure
the safe and efficient use of this KARL STORZ
product, read the entire video system
instruction manual before connecting the
camera system.
WARNING: Read this instruction card
thoroughly and be familiar with its contents
prior to using this equipment.
WARNING: Test this equipment prior to
each surgical procedure. Ensure that the
proper video image appears on all video
monitors before beginning each procedure.
WARNING: Do not plug in the camera
head cable if it is wet.
WARNING: Check the instrument and
accessories used in combination before
every application for unintentional rough
surfaces, sharp corners, burred edges,
and projecting parts, which can endanger
personal safety. Damaged, defective, bent,
or incomplete instruments or accessories
must not be used further under any circum-
stances.
WARNING: Do not exert too much force
on the camera head as it may cause it to
break, bend, or malfunction. Do not over-
load or bend bent instruments back to their
original position.

6
General Information (Contin ed)
Illustrated Description
1. Instrument Coupler
2. Focusing Ring
3. Zoom Ring
4. User control button for scrolling (down-
wards) through the menu or activating a
camera function
5. User control button for scrolling
(upwards) through the menu or activating
a camera function
6. User control button for accessing the
menu/making a selection
Operating Instr ctions
Frequency of the High Definition
camera head (50/60 Hz)
The 3-Z-FI IMAGE 1 S camera head oper-
ates on both 50 z and 60 z frequency.
The frequency can be adapted to suit local
conditions. Refer to the CCU instruction
manual for instruction on how to switch fre-
quency.
1
2 3 4
5 6

Connecting an Endoscope and
Light Cable
The 3-Z-FI IMAGE 1 S camera heads
each have an integrated instrument coupler
and optics. To connect a telescope, turn
the outer ring of the instrument coupler
clockwise and insert the eyepiece of the
endoscope into the coupler.
Connect the light cable to the eyepiece of
the endoscope by tightening the knurled
screw on the light cable through a quarter
turn. Refer to the light cable instruction card
for handling and reprocessing instructions
for the light cable.
Adjusting focus
The focus can be adjusted by turning the
focusing ring on the camera lens.
Adjusting image size
The image size can be adjusted by turning
the zoom ring.
Operating the user control buttons
1. Scroll Up: Scrolls up the menus,
options, etc. Can also be assigned a
programmable function feature.
2. Menu/Select: Access the menu. Once
the menu is displayed, this button can
be used to select the highlighted
option. old this button down for seven
seconds to call up the “Options” menu.
3. Scroll Down: Scrolls down the menus,
options, etc. Can also be assigned a
programmable function feature.
For complete instructions on camera head
button programming and operation, refer to
the CCU instruction manual.
7
Page|5

Operating Instr ctions (Contin ed)
Technical Description
8
TH102 H3-Z-FI IMAGE 1 Camera Head
Image Sensor 3 x 1/3”
Image Format 16:9
Pixels 1920 x 1080p
2073600 pixels
Image Refresh Rate 1.17 lux (50/60 Hz)
1.4 lux (60 Hz)
Focal Length 2x optical zoom
14.8 – 31.3 mm
Dimensions (LxHxW)
Length: 100 mm
Height: 48 mm
Width: 38 mm
Weight 249.5 g

Cleaning, Disinfection and
Sterilization Instr ctions
WARNING: The 3-Z-FI IMAGE1 S camera
head is delivered non-sterile and must be
cleaned and sterilized per validated proce-
dures prior to initial and subsequent uses.
Ca tion: Do not pick up the camera head
by its cable. Always pick up the camera head
first, followed by the cable and connector.
Ca tion: Do not coil the cable too tightly.
Always arrange the cable in loose coil of 15
cm or more in diameter.
Note: When preparing cleaning solutions,
follow the manufacturer’s instructions for
proper concentration and temperature.
Water Quality:
Utility Water:
Water as it comes from the tap that meets
the specifications as defined by AAMI TIR
34: 2014 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 micro-
organisms and the inorganic and organic
material are removed from the water; a final
submicron filtration could also be part of
the treatment process.
Pre-Cleaning (at point-of-use)
Recommended Water Quality: Utility Water
1. Disconnect the telescope from the
camera head.
2. Wipe the camera head thoroughly with a
soft, lint-free disposable cloth moistened
with water or a diluted mild/neutral p
enzymatic cleaner (e.g. Enzol) to
remove all heavy soiling.
3. Contain and transport the contaminated
camera head to the decontamination
area for cleaning.
9

Cleaning, Disinfection and
Sterilization Instr ctions (Contin ed)
Note: If immediate cleaning is not feasible,
place the camera head in a container and
soak for no longer than 30 minutes in a
diluted neutral/mild p enzymatic cleaning
solution (e.g. Enzol).
Manual Cleaning
Recommended Water Quality: Utility Water
Ca tion: WEAR PROTECTIVE GLOVES,
CLOT ING, AND A FACE MASK FOR
CLEANING OF CONTAMINATED INSTRU-
MENTS.
1. Thoroughly rinse the camera head
using a commercial overhead sprayer
nozzle with cold water to remove all
gross debris. Rinse the camera head
unit for a minimum of 1.5 minutes, pay-
ing special attention to the knobs,
crevices, and seams. Then rinse the
connecting cable for a minimum of 30
seconds.
2. Completely immerse the camera head
in a diluted mild/neutral p enzymatic
cleaning solution (e.g. Enzol). Keep
immersed for a minimum of 1 minute.
3. While immersed, use a soft bristle
brush (P/N: 27652/3) to brush all the
surfaces of the camera head unit. Pay
close attention to the seams between
the instrument coupler, focusing ring
and zoom ring. Do not brush the glass
window. Brush for a minimum of 1
minute.
4. Then, use a low-lint wipe to wipe the
entire length of the connecting cable
and the glass window of the camera
head.
10

5. Finish by brushing the entire camera
head, including the entire silicon cable,
card edge connector, paying special
attention to the operating buttons,
screws, knobs, and instrument coupler.
Rinse the bristles of the brush if heavy
debris collects on them. Keep brushing
until there is no visible debris on the
bristles of the brush (minimum of 1
minute).
6. After the immersion and brushing period,
remove the camera head from the
cleaning solution and rinse using a
commercial overhead sprayer nozzle
with cold water. Rinse the camera
head unit for a minimum of 1.5 minutes,
paying special attention to the knobs,
crevices and seams. Then rinse the
connecting cable for a minimum of 30
seconds.
7. Dry the entire camera head with a 60cc
syringe filled with air.
8. After cleaning, visually inspect the
camera head for cleanliness. Do not
proceed with sterilization if residual soil
is visible. Repeat manual cleaning if
the scope is not visually clean.
9. Inspect the camera head for any visible
signs of damage (cuts, dents, or
scratches) that may trap residual
debris. Do not use the camera head if
it is damaged or is difficult to use. The
camera head should be returned to
KARL STORZ for repairs or replace-
ment.
terilization
WARNING: Before sterilization, the instru-
ments must be thoroughly cleaned and all
visible organic material, blood and cleaning
solution completely removed.
11

Cleaning, Disinfection and
Sterilization Instr ctions (Contin ed)
TERRAD terilization ystems
CAUTION: All instruments must be thor-
oughly DRIED before loading into the
STERRAD sterilizer. Loads containing
moisture may cause a cycle cancellation.
CAUTION: Use only FDA-cleared poly-
propylene sterilization wraps and/or poly-
olefin pouches. Do not use paper pouches
or sterilization wraps containing wood pulp
or cotton.
1. Place the camera head in an FDA-
cleared STERRAD compatible instru-
ment tray or container.
2. Wrap the sterilization tray with two single
layers of FDA cleared polypropylene
sterilization wrap, using a sequential
double wrapping technique. If using a
sterilization sealed container refer to
the manufacturer’s instructions for use
on using the correct disposable filters
for the indicated sterilization method.
3. Load the STERRAD sterilizer, arranging
the items such that the hydrogen per-
oxide plasma can surround them. Do
not allow any items to touch the wall of
the sterilizer.
4. Start the STERRAD sterilizer. The follow-
ing cycles have been validated by KARL
STORZ:
- STERRAD 100S Cycle
- STERRAD NX “Standard” Cycle
- STERRAD 100NX “Standard” Cycle
Note: Please consult the STERRAD
Sterilization System User Guide for detailed
instructions for use of the STERRAD
Sterilizers, or contact Advanced
Sterilization Products (ASP) customer serv-
ice at [phone].
12

Terms and Conditions
HIPPING
Although KARL STORZ products are care-
fully packed to minimize in-transit damage,
all shipments should be carefully examined
upon receipt and if a product is damaged,
Customer must document the nature and
extent of the damage and immediately
contact KSEA. If concealed loss or damage
is discovered, Customer must retain all
packing materials and immediately notify
KSEA, requesting an inspection. If shipments
are received short, Customer must contact
KSEA’s Customer Support Department at
once. KSEA reserves the right to make partial
shipments on any Order. Invoices for partial
shipments are payable upon receipt. KSEA
is not liable for any damages caused by or
attributable to delays and/or non-delivery
due to any cause whatsoever.
RETURN POLICY
A return merchandise authorization (RMA)
must be obtained from KSEA’s Customer
Support Department prior to returning any
products. When phoning or writing KSEA, for
an RMA, the Customer Support Represent-
ative must be provided with:
(1) Customer name and number, as it
appears on the invoice;
(2) the telephone number and the person-
to contact;
(3) the applicable P.O. number;
(4) the KARL STORZ catalog number and,
if applicable, the serial number for
each product; and,
(5) the reason for the return.
KSEA reserves the right to refuse or return
any products sent back to KSEA without
prior authorization of its Customer Support
Department. Returns must be carefully
packed and shipped pre-paid to KSEA, attn:
RMA number. KSEA’s Customer Support
Department will provide the return address
and the RMA number.When returning prod-
ucts, Customer should include a copy of
13

Terms and Conditions (Contin ed)
the original invoice or packing slip to
ensure prompt issuing of credit. Full credit
will only be issued for products that are
returned within 30 days of invoice date and
so long as such items are unused, in resal-
able condition and in their original product
container. All products returned after 30
days from the date of invoice are subject to
a 15% restocking fee. Shipping charges
will be reimbursed, restocking fees will not
be charged and full credit will be given if
the return was due to an error on the part of
KSEA.
The following products may not be returned
for credit or exchanged:
(1) products held longer than 90 days
from invoice date;
(2) sterile packaged products where the
package is opened and/or damaged;
(3) discontinued products;
(4) instruments that are etched or
engraved by Customer;
(5) products damaged by the Customer;
(6) products purchased “as is” or as demo
products; and,
(7) used products.
In order to prevent the transmission of dis-
ease to the medical facilities’ and/or
KSEA’s personnel, all products must be
cleaned and then sterilized and/or disinfec-
ted before sending such products back to
KSEA, who reserves the right to return
unclean and contaminated products to the
Customer. Additionally, if any product
becomes damaged and is not immediately
returned, KSEA assumes no responsibility
or liability for Customer’s continued use of
that damaged product. KSEA does not
guarantee the performance, and may
decline to repair or accept for repair/
exchange, any product that has been
repaired, modified and/or altered by any
person or entity other than KSEA or an
authorized repair facility of KSEA.
14

IN TALLATION, PREVENTATIVE
MAINTENANCE, AND OTHER
ERVICE
Subject to resource availability, KSEA may,
in its sole discretion, (i) install and setup the
product, perform preventative maintenance
services, provide onsite or remote trouble-
shooting services and other services, (ii)
provide software updates and (iii) provide
loaners in case of back orders.
TRAINING
To the extent reasonable as to the com-
plexity and quantity of products, KSEA will
provide training regarding the proper use
of products at or near the time of delivery or
installation, as applicable. KSEA may also
provide additional training regarding the
proper use of products upon Customer’s
request, in KSEA’s sole discretion and sub-
ject to availability of KSEA personnel.
REPAIR PROGRAM
If repairs become necessary, for other than
damages incurred during initial shipment,
the Customer must follow the RMA proce-
dure set forth in the "Return Policy" in
Section 6, above. Warranty repairs will be
made without charge (see "Warranty
Policy," Section 10 below, for covered
repairs). All other repairs are subject to
KSEA's applicable standard repair or
exchange charges. If requested, Customer
will be advised of the estimated cost of the
repair work or a product exchange before it
is undertaken. All repairs carry a 90 day
warranty. Exchange products carry the
applicable KARL STORZ product warranty.
If the damaged product is not returned
within thirty (30) days of receipt of the
replacement product, Customer will be
invoiced for the full list price of the replace-
ment. Subject to the availability of product,
KSEA may, in its sole discretion, provide
Customer with loaner product while non-
warranty repairs are being made. Subject
to resource availability, KSEA may, in its
15

Terms and Conditions (Contin ed)
sole discretion, perform minor non warranty
repairs without charge. KSEA reserves the
right to refuse or return any product sent
back without prior authorization of KSEA’s
Customer Support Department.
WARRANTY POLICY
Except as otherwise provided herein and/or
by the applicable warranty information for a
specific product or type of product, all
products are generally warranted to be in
good working order at the date of delivery
and free from defects in workmanship and
materials for one (1) year from date of deliv-
ery. owever, since some products carry a
shorter or a longer warranty period,
Customer should check with KSEA's
Customer Support Department or product
specific literature, instruction manual
and/or labeling for the exact warranty peri-
od. Any such product(s) with a defect
occurring during the applicable warranty
period will be promptly replaced or, at the
sole discretion of KSEA, repaired at no
charge to Customer. Subject to availability
of product, KSEA may, in its sole discretion,
provide Customer with loaner product while
the defective product is being replaced or
repaired during warranty period.
THIS WARRANTY IS IN LIEU F ALL
THER WARRANTIES, EXPRESS, IMPLIED
AND/ R STATUT RY, INCLUDING, BUT
N T LIMITED T WARRANTIES F MER-
CHANTABILITY, FITNESS AND/ R F
SUITABILITY F R A PARTICULAR PUR-
P SE, WITH RESPECT T ALL KARL
ST RZ PR DUCTS R SERVICES. ANY
AND ALL THER WARRANTIES, REPRE-
SENTATI NS AND/ R GUARANTEES,
F ANY TYPE, NATURE R EXTENT, BE
IT IMPLIED, EXPRESS AND/ R WHETHER
ARISING UNDER R AS A RESULT F
ANY STATUTE, LAW, C MMERCIAL
USAGE, CUST M, TRADE R THER-
WISE, ARE HEREBY EXPRESSLY
EXCLUDED AND DISCLAIMED.
16

Any contrary course of performance by and
between the parties will not modify any rep-
resentations and/or warranties set forth
herein. KSEA neither assumes nor authoriz-
es any person to assume for it any other lia-
bilities in conjunction with and/or related to
the sale and/or use of its products. To
ensure proper use, handling and care of
KARL STORZ products, Customer should
consult the product specific literature,
instruction manual, and/or labeling includ-
ed with the product or otherwise available.
Repairs, modifications or alterations of
KARL STORZ products, performed by any
person or entity, other than by KSEA or an
authorized repair facility of KSEA, nullifies
and otherwise voids all applicable KARL
STORZ warranties. Repair or replacement
of a KARL STORZ product shall not extend
the term of any applicable warranty. The
remedies provided herein are Customer's
exclusive remedies under this Warranty
Policy.
LIMITATION OF LIABILITY
KSEA is not liable, either directly or by way
of express or implied indemnity, for: (1) any
damages which might arise or be caused,
whether by the Customer or by any of the
users of the products provided by KSEA, as
a result of, in connection with, or otherwise
attributable to:
(a) misuse, abuse, mishandling and/or
improper operation and/or storage;
(b) repairs, servicing, modifications and/or
alterations performed by any person or
entity, other than KSEA or an author-
ized repair facility of KSEA;
(c) use in combination with adaptors,
accessories and/or equipment from
other manufacturers unless authorized
or recommended by KSEA,
(d) use in any manner other than those for
which such products are designed
and are otherwise intended to be used,
or
17

Terms and Conditions (Contin ed)
(e) a failure to comply with power and
groundling specifications provided by
KSEA
and, (2) any special, incidental, conse-
quential, punitive, exemplary or indirect
damages, including but not limited to
alleged damages for delayed shipment,
non-delivery, product failure, product
design or production, inability to use such
products or services, loss of future busi-
ness (lost profits), or from any other cause,
whatsoever, in connection with or arising
from the purchase, sale, lease, rental,
installation or use of KARL STORZ prod-
ucts, even if KSEA has been advised of the
possibility of such damages.
S ME JURISDICTI NS D N T ALL W
EXCLUSI NS AND DISCLAIMERS F
CERTAIN WARRANTIES R LIMITATI NS
F LIABILITY, S THE LIMITATI NS
AND/ R EXCLUSI NS, SET F RTH IN
THESE TERMS AND C NDITI NS, MAY
N T APPLY. IN THAT EVENT, KSEA’S
LIABILITY WILL BE LIMITED T THE
GREATEST EXTENT PERMITTED BY
LAW IN THE SUBJECT JURISDICTI N.
OFTWARE OWNER HIP AND
LICEN ING
With respect to products provided by KSEA
and/or its affiliated/related entities (collec-
tively, “KARL STORZ”) and containing soft-
ware components, Customer is granted a
non-exclusive, limited, non-transferable
license (the “License”) to use the pro-
grammed logic, computer programs and/or
software, including software developed by
or on behalf KARL STORZ (“KARL STORZ
Software”) and/or software developed by or
on behalf of a third party (“Third Party
Software”) (collectively, “Software”) embed-
ded in, or for use in conjunction with, such
products, internally, but only in the form in
which delivered to Customer and for the
sole purpose of operating in accordance
with KARL STORZ's written instructions for
the products provided to Customer (and for
18

no other product or purpose). The Software,
and all modifications, enhancements and
upgrades thereto, will, at all times, remain
the property of KARL STORZ or the appli-
cable third party. Customer may not dupli-
cate, copy, reverse-engineer, de-compile,
or disassemble the Software or in any way
modify the Software. Customer has no right
to, and may not, create derivatives of the
Software, and Customer may not attempt to
copy, create or re-create the source code
of the Software. Any and all such modifica-
tions or enhancements to the Software by
Customer, in contravention of this License,
will immediately become the sole property
of KARL STORZ.
Customer hereby acknowledges and
agrees that
(i) the purchase, lease or other acquisi-
tion of products does not constitute a
transfer of the Software,
(ii) the Software is the property of KARL
STORZ or the applicable third party,
(iii) Customer neither owns nor acquires
any interest in any copyright, patent or
other intellectual property right in or to
the Software as a result of such pur-
chase, lease or other acquisition of
products,
(iv) KARL STORZ, or the applicable third
party, retains and owns all right, title,
and interest in and to the Software and
the ownership rights therein, at all
times, regardless of the form or media
in or on which the original or other
copies of the Software may exist, and
(v) by using the products,
Customer is subject to, and is bound by,
the terms of any separate third-party
license agreement relating to the Third
Party Software. In the event of a failure of
Customer or its agents, employees or rep-
resentatives, to comply with any terms and
conditions of the License herein granted,
the License will, without any further action
by KARL STORZ or any other party, imme-
diately end and terminate.
19

KARL TORZ E & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen
Postfach 230
78503 Tuttlingen
Germany
Telefon: [phone]
Telefax: [phone]
Email: [email protected]
Web: www.karlstorz.com
IM-000014-2.0 (09/20)