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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.

Caution: 

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.

Summary of Contents for IMAGE 1 S H3-Z FI

Page 1: ...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 ...

Page 2: ......

Page 3: ...nd 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 ...

Page 4: ... carefully before proceeding to work with the instrument Keep this manual available for ready reference Intended Use The KARL STORZ IMAGE 1 S H3 Z FI Camera Head 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 thoroughl...

Page 5: ...ra 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...

Page 6: ...crolling upwards through the menu or activating a camera function 6 User control button for accessing the menu making a selection Operating Instructions Frequency of the High Definition camera head 50 60 Hz The H3 Z FI IMAGE 1 S camera head oper ates on both 50 Hz and 60 Hz frequency The frequency can be adapted to suit local conditions Refer to the CCU instruction manual for instruction on how to...

Page 7: ...ble 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 h...

Page 8: ...3 Z FI IMAGE 1 S 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 ...

Page 9: ...ap 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 ...

Page 10: ...l 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 pH 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 ...

Page 11: ... 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 sign...

Page 12: ...ropylene 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 s...

Page 13: ...ays 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 ...

Page 14: ...kage 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 pr...

Page 15: ...ecome 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 ...

Page 16: ...al 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 warran...

Page 17: ...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...

Page 18: ... OR EXCLUSIONS SET FORTH IN THESE TERMS AND CONDITIONS MAY NOT APPLY IN THAT EVENT KSEA S LIABILITY WILL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW IN THE SUBJECT JURISDICTION SOFTWARE OWNERSHIP AND LICENSING 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 limit...

Page 19: ...ftware 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 ...

Page 20: ...ORZ SE Co KG Dr Karl Storz Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon 49 0 7461 708 0 Telefax 49 0 7461 708 105 Email info karlstorz com Web www karlstorz com IM 000014 2 0 09 20 ...

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