Carl Zeiss
Colposcope KSK 150 FC Instructions for Use Ver 6.1 Dec 2012
Instructions for Use
96 Pages
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Carl Zeiss
Kolposkop KSK 150 FC
Instructions for Use G-30-1158-en Version 6.1 12/14/2012
KSK 150 FC
About this manual
Orientation guides
Scope
Manufacturer
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.
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Store them for the entire service life of the device.
•
Pass them on to every subsequent owner or user of the device.
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The section summary at the beginning of the Instructions for Use provides an overview of the topics.
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You will also find a detailed table of contents at the beginning of each chapter.
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The index facilitates searching via keywords.
These Instructions for Use apply to the Kolposkop KSK 150 FC. Reference number: 302303-0000-000 Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany
Fax: + 49 (0) 7364 - 20 4823 E-Mail: [email protected] Internet: www.meditec.zeiss.com
Subject to changes in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. Copyright
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© Carl Zeiss Meditec AG 2012 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, these Instructions for Use may be digitized and archived for internal use. Access to this data by third parties is not permissible and must be prevented.
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Chapter overview
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Chapter:
Safety Measures
5
Chapter:
System Overview
25
Chapter:
Preparations for use
39
Chapter:
Operation
53
Chapter:
What to do in the event of malfunctions
59
Chapter:
Care and Maintenance
61
Chapter:
System Data
73
Chapter:
Index
89
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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...7 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 Symbols and labels on the device ...16
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Safety Measures
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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 important 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. WARNING
Warning label, which may refer to fatal injuries or severe injuries if precautions are not followed.
CAUTION
Indicating a hazard, which may lead to moderately severe injuries if risks are not avoided.
NOTE
Warning label, which may refer to minor injuries and property damages if precautions are not followed.
Information symbols The following information symbols are used in these Instructions for Use: –
Listing
Requirements for an action •
Prompt for action
Result of an action Additional information and hints
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Safety Measures
Target group These Instructions for Use are intended for physicians, nurses and other medical 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 Kolposkop 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.
Normal use
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The gynecologist brings the colposcope into position and performs rough focusing.
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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.
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A video system can be attached to the colposcope for teaching purposes or for visualizing the treatment / surgical process.
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Safety Measures
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After use, the colposcope is swung out of the working area and can be cleaned and disinfected.
Liability and warranty Warranty and liability depend on the applicable contractual stipulations. NOTE
Loss of warranty Modifications to this system are not permissible. The manufacturer is not liable for damage caused by unauthorized persons tampering with the system. Furthermore, this will forfeit any rights to claim under warranty.
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Safety Measures
Notes for the operator The correct use of the device is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the content of these Instructions for Use before starting up the device. Please also observe the Instructions for Use of additional instrument equipment. Further information is available from our service department or from authorized representatives.
Legal regulations
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Only operate the device within the scope of its intended use.
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Only personnel who have undergone training and instruction are allowed to use this instrument. It is the responsibility of the customer or institution operating the equipment to train and instruct all staff using the equipment.
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Please keep these Instructions for Use where there are easily accessible at all times for the persons operating the system.
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Note the symbols and labels attached to the device (see page 16).
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Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned.
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This equipment must not be modified without the manufacturer's approval. If the equipment is modified after consulting the manufacturer, appropriate examinations and tests must be performed to guarantee the further secure use of the device. The manufacturer is not liable for any damage caused by unauthorized use of the equipment. Furthermore, this will forfeit any rights to claim under warranty.
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If required by the regulations and directives applicable in the country of use, connect the system to a special emergency backup power supply.
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Safety Measures
KSK 150 FC
Ambient requirements
Notes on the system
Electrical safety
Transport & service
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•
Do not operate the system contained in the delivery package –
in explosion-risk areas,
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if inflammable anesthetics or volatile solvents such as alcohol, benzine or similar chemicals are present at a distance of less than 25 cm.
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Do not station or use the instrument in damp rooms. Do not expose the instrument to water splashes, dripping water or sprayed water.
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Do not place any fluid-filled containers on top of the instrument. Make sure that no fluids can seep into the instrument.
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Make sure that the installation conditions and the use of the system meet surgical requirements: –
low vibration
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clean environment
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avoidance of extreme mechanical stress.
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Always switch off the system before disconnecting it from / connecting it to line power, for cleaning its surface or if it will not be used for a prolonged period of time.
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A potential equalization connector is provided on the underside of the carrier arm. This connector can be used for placing other active devices at the same ground potential or for redundant grounding to protective earth.
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Please note the information on EMC (electromagnetic compatibility) in the chapter "System Data" on page 82.
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In order to prevent any impairment of the device's safety due to age, wear, etc., the user must ensure that the device is subjected to the necessary safety checks (see section "Care and maintenance").
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Never place multiple connectors on the floor.
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Never connect any additional multiple connectors.
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The device shall only be transported over long distances (e.g. move, returning for repair etc.) within its original packaging or in a special return packaging. Please contact your dealer or Carl Zeiss Service.
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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 your local Carl Zeiss Service.
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With increasing age of the light source, the actual illumination intensity delivered at the respective setting decreases (this is a normal property of the system).
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Safety Measures
Additional devices that are connected to electronic medical devices shall comply with the relevant standards and guidelines (for example IEC 60950 for data processing devices). Furthermore, any configurations shall comply with normative requirements for electronic medical devices/please refer to IEC 60601-1-1:2000 or IEC 60601-1:2005, chapter 16). The one who is connecting additional devices to electronic medical devices acts as system configurer and is responsible for the system complying with the normative requirements for electronic medical devices. Please note that local legislation takes priority over the above-mentioned normative requirements. If you have any questions, please contact your local dealer or Carl 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 further 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 display 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
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Never attempt to forcefully attach any electrical connections (plugs, bushings). 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.
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Never change modules and accessories during a surgical procedure or above the patient!
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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!
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Mounting and removing modules and accessories may lead to unintended tilting of the colposcope.
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Make sure that the maximum permissible load on the suspension arm is not exceeded.
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After every change in configuration and before every use, rebalance the completely equipped colposcope (without the patient and at a safe distance from other persons and equipment).
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Reset the friction adjustment screws.
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Position the device in such a way that you can move it away from the patient at any time.
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Floor stand only: Risk of crushing and toppling during transportation of the system. Move the floor stand into its transport position.
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Floor stand only: When crossing thresholds, only lift the device by the carrier arm near the lamp housing.
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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.
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Never touch areas marked with the indicating label "Risk of crushing" while the device is moved or brought into position for work / transportation.
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Always run cables in a manner that will not impede the user's movements.
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Always make sure before surgery that the illumination is intact.
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Have an OR illuminator ready during every procedure.
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If the light intensity is set too high, the patient may sustain second / third grade burn injuries.
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Never leave the device unattended when its light source is switched on.
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Safety Measures
•
Make sure the operating staff has been briefed on the use of the device.
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Never cover any ventilation openings. This may cause the light source of the device to overheat and fail.
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Make sure that all symbols and labels on the instrument are legible and understood by operating personnel.
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Carry out the functional test described in the section "Operation" before every use of the device.
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Only use the system after it has been properly balanced.
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Never operate the system unattended.
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Avoid looking directly into the light source, e.g. into the objective lens or light guide.
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Start setting the lamp brightness at the lowest value and gradually increase the brightness until the image is sufficiently bright.
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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.
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When setting up your system, make sure to comply with the requirements of IEC 60601-1-1:2000 and IEC 60601-1:2005 Chapter 16.
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Do not pull at the light guide, power cord or any other connecting cables.
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If you 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.
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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 stating it is out of order and contact our service representative.
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Please note that the interaction of heat and antimicrobial substances in incision foils may lead to an increase in the patient's reaction to these substances.
During use
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Safety Measures
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After every use
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Always use the master switch to turn off the device if it is not in use.
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If the suspension system collides with other components, it may be damaged and parts may fall down. Move the suspension system carefully and avoid collisions.
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If the suspension system nevertheless collides with other devices, you must have it checked by Carl Zeiss Service.
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Insufficient, incorrect or wrong cleaning or disinfection contrary to the directions 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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Safety Measures
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Symbols and labels on the device
CAUTION
Note the warning labels and notes! •
If you notice that any label is missing on your system or has become illegible, please contact us or one of our authorized representatives. We will supply a replacement.
0
1 "Interpupillary distance adjustment" label Knob for adjusting the interpupillary distance.
2 "Brake released / applied" label Label on the knob for adjusting the friction of the rotation and tilt motions. 3 "Risk of crushing" label Fingers may be crushed in this area. Do not touch this area while the colposcope is being moved. 4 Balance of suspension arm After all accessories have been attached to the colposcope, this adjustment screw can be used to set the balance of the suspension arm. 5 "Filter module" marking The illustration on the left shows the marking of the filter module switch.
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3
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6 "Brightness" marking The illustration on the left shows the marks on the knob for adjusting the brightness level of illumination.
7 SIP label The SIP label contains the following information:
XXXX XXXXXX
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Manufacturer (company name)
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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.
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SIP No. A unique identification number assigned to your device.
8 Potential equalization Here, the system can be connected to the potential equalization system.
9 "Focusing" label This label identifies the button for fine adjustment of focusing on the colposcope.
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10 Magnification changer marking The illustration on the left shows the marks on the knob for adjusting the magnification.
max.2.1 kg
11 "Maximum load" warning label Maximum load capacity 2.1 kg with asymmetric load distribution. For maximum load capacity with asymmetric load distribution see page 75.
12 "Risk of crushing" label Fingers may be crushed in this area. Do not touch this area while the colposcope is being moved. 13 "Colposcope" type label This label contains the following information: –
Manufacturer (company name): Carl Zeiss
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Labeling: 150 FC
14 "Hot surfaces" warning label Hot surfaces may cause burns.
15 Transport 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 position. •
Before transporting the system, make sure that it is in this position in order to avoid any damage.
16 "Observe disposal regulations" label Do not dispose of electrical and electronic devices along with normal domestic waste. For more information on the disposal of electrical and electronic devices, please see chapter "Maintenance and care".
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