Zeiss KSK 150 FC User manual

ZEISS
Colposcope
KSK 150 FC
Instructions for Use
G-30-1158-en
Version 7.1
2015-06-11

KSK 150 FC
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About this manual These Instructions for Use are part of the delivery package.
• Carefully read them before using the device.
• Keep them at the site of use of the device.
• Store them for the entire service life of the device.
• Pass them on to every subsequent owner or user of the device.
Orientation guides – The section summary at the beginning of these Instructions for Use pro-
vides an overview of the topics.
– You will also find a detailed table of contents at the beginning of each
chapter.
– The index facilitates searching via keywords.
Area of application These Instructions for Use apply to the Colposcope KSK 150 FC
with the order number: 302303-0000-000.
Manufacturer
Copyright © Carl Zeiss Meditec AG 2015
All rights reserved. Reprints and reproductions, including excerpts, are not
permissible. However, these Instructions for Use may be digitized and ar-
chived for internal use. Access to this data by third parties is not permissible
and must be prevented.
Original language These Instructions for Use were originally drafted and published in German.
Change note Subject to change in design and scope of delivery and as a result of ongoing
technical development.
Printed in Germany.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
Fax: + 49 (0) 73 64 - 20 48 23
Email: [email protected]
Internet: www.meditec.zeiss.com

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Chapter overview
Chapter: Safety Measures 5
Chapter: System Overview 23
Chapter: Preparations for use 35
Chapter: Operation 51
Chapter: What to do in the event of malfunctions 56
Chapter: Care and Maintenance 57
Chapter: System Data 67
Chapter: Index 85

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KSK 150 FC Safety Measures
Safety Measures
Key to symbols ..................................................................................6
Hazard symbols ...........................................................................................6
Information symbols....................................................................................6
Target group .....................................................................................7
Field of application ............................................................................7
Intended use ...............................................................................................7
Normal use..................................................................................................8
Liability and warranty........................................................................8
Notes for the operator.......................................................................9
Prerequisites for operation ..............................................................11
Prior to the very first use............................................................................11
Before every use........................................................................................12
During use.................................................................................................13
After every use ..........................................................................................14
Labeling, warnings, notes and symbols ...........................................16

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Key to symbols
We would like to inform you about safety aspects which must be observed
when handling this device. This chapter contains a summary of the most im-
portant information concerning matters relevant to instrument safety.
Hazard symbols
The following safety information has been incorporated into the Instructions
for Use. Please note this information and be particularly careful in these cases.
Information symbols
The following information symbols are used in these Instructions for Use:
Additional information and tips
WARNING Indicates a hazard which can lead to death or severe injury if it is not pre-
vented.
CAUTION Indicates a hazard which can cause minor to moderate injury if it is not pre-
vented.
NOTE Indicates a hazard which can cause damage to material if it is not pre-
vented.
–Listing Prerequisite for an action
• Prompt for action Result of an action

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KSK 150 FC Safety Measures
Target group
These Instructions for Use are intended for physicians, nurses and other med-
ical staff who prepare, operate or maintain the device after appropriate
training. It is the duty of the customer or institution operating the system to
train and instruct all staff using the system.
Additional service activities are not part of these Instructions for Use. They will
be performed by staff especially trained for this purpose by Carl Zeiss.
Field of application
Intended use
The Colposcope KSK 150 FC provides a view of vagina, vulva and cervix by
means of magnification and illumination support.
It is used to examine the selected regions and supports the visualization of
gynecologic treatments and surgical procedures.
The device is positioned outside of the vagina.

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Normal use
– The gynecologist brings the colposcope into position and performs rough
focusing.
– During treatment or surgery, the gynecologist positions the device on the
site to be focused and changes the magnification, if a magnification
changer is present. The illumination can be switched on or off as required.
– A video system can be attached to the colposcope for teaching purposes
or for visualizing the treatment / surgical process.
– After use, the colposcope is swung out of the working area and can be
cleaned and disinfected.
The product life cycle totals 8 years.
Liability and warranty
Warranty and liability depend on the applicable contractual stipulations.
Loss of warranty
Modifications to this device are not permitted. The manufacturer is not liable
for damages caused by unauthorized use of the device. Furthermore, this will
forfeit any rights to claim under warranty.

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KSK 150 FC Safety Measures
Notes for the operator
• Please thoroughly familiarize yourself with the contents of the Instructions
for Use before starting up the system. Please also observe the Instructions
for Use of any additional equipment.
• Only personnel who have undergone appropriate training and instruction
are allowed to use this device. It is the responsibility of the customer or
the company operating the device to train and instruct all operating per-
sonnel.
• Keep the Instructions for Use available at all times for the operating per-
sonnel.
• This device must not be modified without the manufacturer's approval. If
the device is modified, suitable inspections and testing must be completed
to ensure that it can still be used safely.
The manufacturer is not liable for damages caused by unauthorized use of
the device. Furthermore, this will forfeit any rights to claim under warran-
ty.
• Never open the device! The device contains freely accessible live compo-
nents. If you remove the housing, you run the risk of electric shock.
• Modifications and repairs of this system or any systems operated together
with this system may only be performed by our service representative or
by other authorized persons.
• Only use the system in accordance with the intended use.
• Note the symbols and labels attached to the system! Please refer to the
chapter on "Safety measures" and the section on "Labeling, warnings,
notes and symbols".
• Observe the applicable legal accident prevention and occupational safety
provisions of your country.
• If required by the applicable national laws and regulations, connect the
device to the special "equivalent power supply".
• Ensure that the installation conditions and the use of the device meet sur-
gical requirements:
–Lowvibration
– Clean environment
– Avoid extreme mechanical loading

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• Do not use power-operated devices included in the delivery package
– in explosive atmospheres,
– at a distance of less than 25 cm from flammable anesthetics or volatile
solvents such as alcohol, benzine or similar substances.
• Do not use or store the system in damp rooms. Do not expose the system
to water splashes, dripping water or sprayed water.
• Ensure that fluids cannot penetrate into the device.
• Never directly look with binocular tube, object lens or an eyepiece into the
sun.
A potential equalization connection can be found on the underside of the car-
rier arm (see IEC 60601-1:2005 + A1:2012). This makes it possible to connect
other active devices to the same earth potential or it can be used for the re-
dundant connection with the grounding conductor.
• Always switch off the system before connecting it to / disconnecting it
from line power, for cleaning its surface or if it will not be used for a pro-
longed period of time.
• Please note the information on electromagnetic compatibility (EMC) in the
chapter on "System data" and the section on "EMC - electromagnetic
compatibility".
• The maximum brightness of the lamp(s) can drop over time (normal device
attribute).
• Transport the device over long distances (e.g. relocation, return for repair)
only in its original packaging or special return packaging. Please contact
your dealer or Carl Zeiss Service.
• Pay attention to the places on the device identified by the information la-
bel "Risk of crushing". In these places there a risk of getting your fingers
crushed! Do not touch these areas while the device is being moved.
• If a failure occurs which you cannot correct with the aid of the chapter
"What to do in the event of malfunctions"“, attach a sign to the system
stating it is out of order and contact the Carl Zeiss service staff.
• As the operator, have regular safety checks performed on this device to
prevent a reduction in the safety of the device as a result of aging, wear,
etc. See the chapter on "Care and maintenance" and the section on "Safe-
ty check".

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KSK 150 FC Safety Measures
System kit Any additional equipment connected to medical electrical devices must de-
monstrably comply with the applicable standards and directives (e.g. IEC
60950-1:2005, modified + Cor.:2006 + A1:2009, modified + A1:2009/
Cor.:2012 + A2:2013, modified for data processing equipment).
Furthermore, any configurations must comply with normative requirements
for electronic medical devices (see IEC 60601-1-1:2000 or IEC 60601-1:2005
+ A1:2012, chapter 16).
Anyone connecting additional equipment to medical electrical devices is a
system configurer and as such is responsible for compliance of the system
with the normative requirements for medical electrical systems.
Please note that local legislation takes priority over the above-mentioned nor-
mative requirements. If you have any questions, please contact your local
dealer or ZEISS Service.
Prerequisites for operation
Prior to the very first use
Our service representative or an expert authorized by us will install the system.
Please make sure that the following requirements continue to be met for fur-
ther operation:
The connecting components have been properly connected. The screw
connections have been firmly tightened.
All cables and connectors are in a perfect condition, i.e. they do not dis-
play any worn areas, kinks or other defects.
The voltage set on the system corresponds to the rated line voltage on the
site of installation.
Insert the power plug only into a socket that is fitted with a flawless
protective earth conductor.
The power cord being used is the one designed for use with this system.

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Before every use
• Never attempt to forcefully attach any electrical connections (plugs, bush-
ings). If a plug cannot be connected easily, check again whether the plug
and socket are made to fit. If the plug connection is damaged, please call
our service department. They will be happy to assist you.
• Never change modules and accessories during a surgical procedure or
above the patient!
• After every change in configuration and before every use, make sure that
the modules and accessories are securely locked in position. Make sure
that all securing screws and locking screws are firmly tightened!
• Mounting and removing modules and accessories may lead to unintended
tilting of the colposcope.
• Make sure that the maximum permissible load on the suspension arm is
not exceeded.
• After every change in configuration and before every use, rebalance the
completely equipped colposcope (without the patient and at a safe dis-
tance from other persons and equipment).
• Reset the friction adjustment screws.
• Position the device in such a way that you can move it away from the pa-
tient at any time.
• Floor stand only: Risk of crushing and toppling during transportation of
the system.
Move the floor stand into its transport position.
• Floor stand only: When crossing thresholds, only lift the device by the car-
rier arm near the lamp housing.
• Floor stand only: Press the locking tabs on the stand base to secure the
stand in position. Make sure that the stand is stable and cannot roll away.
• Never touch areas marked with the indicating label "Risk of crushing"
while the device is moved or brought into position for work / transporta-
tion.
• Always run cables in a manner that will not impede the user's movements.
• Always make sure before surgery that the illumination is intact.
• Have an OR illuminator ready during every procedure.
• If the light intensity is set too high, the patient may sustain second / third
grade burn injuries.
• Never leave the device unattended when its light source is switched on.

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KSK 150 FC Safety Measures
• Make sure the operating staff has been briefed on the use of the device.
R077 • Never cover any ventilation openings. This may cause the light source of
the device to overheat and fail.
• Make sure that all symbols and labels on the instrument are legible and
understood by operating personnel.
• Carry out the functional test described in the section "Operation" before
every use of the device.
During use
• Only use the system after it has been properly balanced.
• Never operate the system unattended.
• Avoid looking directly into the light source, e.g. into the objective lens or
light guide.
• Start setting the lamp brightness at the lowest value and gradually in-
crease the brightness until the image is sufficiently bright.
• Defective accessories or accessories not approved by Carl Zeiss may lead
to increased leakage current!
Never touch signal interfaces while in contact with the patient.
• The main plug must only be connected to a socket with a faultless protec-
tive ground conductor.
• When setting up your system, make sure to comply with the requirements
of IEC 60601-1-1:2000 and IEC 60601-1:2005 + A1:2012, Chapter 16.
• Do not pull at the light guide, power cord or any other connecting cables.
• If you need to change the lamp shortly after it has failed, the lamp will still
be very hot. Use heat-resistant protective gloves when replacing the lamp
to prevent burns.
• If a failure occurs which you cannot correct with the aid of the chapter
"What to do in the event of malfunctions“, attach a sign to the device stat-
ing it is out of order and contact our service representative.
• Please note that the interaction of heat and antimicrobial substances in in-
cision foils may lead to an increase in the patient's reaction to these sub-
stances.

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After every use
• Always use the master switch to turn off the device if it is not in use.
• If the suspension system collides with other components, it may be dam-
aged and parts may fall down.
Move the suspension system carefully and avoid collisions.
• If the suspension system nevertheless collides with other devices, you
must have it checked by Carl Zeiss Service.
• Insufficient, incorrect or wrong cleaning or disinfection contrary to the di-
rections in these Instructions for Use may expose the patient or medical
staff to a considerable risk of infection. For more information, please see
"Maintenance of the device" in the chapter "Care and Maintenance".

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Labeling, warnings, notes and symbols
Warning and information labels, explanation and positioning
NOTE Observe the warning labels and signs!
R021
• If you notice that any label is missing on your device or has become illeg-
ible, please contact us or one of our authorized representatives. We will
supply you with replacements.
1Label "Brake released / applied"
Label on the knob for adjusting the friction of the rotation and tilt mo-
tions.
2Label "Risk of crushing"
Fingers may be crushed in this area. Do not touch this area while the col-
poscope is being moved.
3Transport position
Certain precautions must be observed for transportation or lifting of the
device. Please refer to the relevant information in the Instructions for Use.
• This imprint on the housing informs you of the correct transport posi-
tion. Before transporting the system, make sure that it is in this posi-
tion in order to avoid any damage.
4Power switch
The two positions of the power switch are marked as shown in the illus-
tration on the left.
5Balance of suspension arm
After all accessories have been attached to the colposcope, this adjust-
ment screw can be used to set the balance of the suspension arm.
6"Maximum load" warning label
Maximum load capacity 2.1 kg with asymmetric load distribution.
For maximum load capacity with asymmetric load distribution see
Page 69.
max.2.1 kg

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7SIP label
The SIP label contains the following information:
– Manufacturer (company name)
– Your options to contact the device manufacturer,
i.e., phone number, fax number and email address of the local contact
of the national Carl Zeiss sales organization.
–SIPnumber
A unique identification number assigned to your device.
8Logo of the manufacturer
9CCU rating label
The rating label provides the following information:
– Instrument type Camera control unit
– Serial number SN HWxxxxxE
– Order number 301900-8700-000
– Type of current DC
– Rated voltage 12-15V
– Connected load 18 VA
10 "Hot surfaces" warning label
Hot surfaces may cause burns.
11 "Instructions for Use" label
Observe the Instructions for Use or accompanying documents.
12 Label "Risk of crushing"
Fingers may be crushed in this area. Do not touch this area while the col-
poscope is being moved.

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13 Rating label
The rating label provides the following information:
Manufacturer's symbol
Manufacturer (company name)
Manufacturer's address
Serial number
Device name
Reference number
Rated voltage
Connected load
Power frequency range
Maximum total weight
(with installed safe workload)
CSA approval
CE marking
14 "Disconnect from power supply" warning label
This warning label advises you to disconnect the device from the power
supply before changing the fuse or performing other work on the device.
15 "Observe disposal regulations" information sign
Do not dispose of electrical and electronic devices along with normal do-
mestic waste. For more information on the disposal of electrical and elec-
tronic devices, please see "Maintenance and care".
16 "Rated voltage" display window
The set rated voltage of the power supply unit is indicated in this display
window.
17 Fuse ratings
This imprinted text on the housing informs you of the required device fuse
for the relevant voltage range. For further information, please see section
"Changing the fuse" on Page 64.
18 "Observe the Instructions for Use" label
Observe instructions for use or accompanying documents
19 Date of manufacture
This label indicates the date of manufacture for the device.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena, Germany
KSK 150 FC
100/110/120/127/
220/230/240V
200 VA
50Hz - 60Hz
Max. 60 kg