Zeiss KSK 150 FC Instructions For Use Manual
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Zeiss KSK 150 FC Instructions For Use Manual

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

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Summary of Contents for Zeiss KSK 150 FC

  • Page 1 ZEISS Colposcope KSK 150 FC Instructions for Use G-30-1158-en Version 7.1 2015-06-11...
  • Page 2 – 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 Carl Zeiss Meditec AG...
  • Page 3 KSK 150 FC Chapter overview Chapter: Safety Measures Chapter: System Overview Chapter: Preparations for use Chapter: Operation Chapter: What to do in the event of malfunctions Chapter: Care and Maintenance Chapter: System Data Chapter: Index Version 7.1 G-30-1158-en Page 3...
  • Page 4 KSK 150 FC Version 7.1 Page 4 G-30-1158-en...

  • Page 5: Table Of Contents

    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...

  • Page 6: Key To Symbols

    Safety Measures KSK 150 FC 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.

  • Page 7: Target Group

    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.

  • Page 8: Normal Use

    Safety Measures KSK 150 FC 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.

  • Page 9: Notes For The Operator

    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.
  • Page 10 "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.

  • Page 11: Prerequisites For Operation

    KSK 150 FC Safety Measures Any additional equipment connected to medical electrical devices must de- System kit 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).

  • Page 12: Before Every Use

    Safety Measures KSK 150 FC 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.

  • Page 13: During Use

    • 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.

  • Page 14: After Every Use

    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.
  • Page 15 KSK 150 FC Safety Measures Version 7.1 G-30-1158-en Page 15...

  • Page 16: Labeling, Warnings, Notes And Symbols

    Safety Measures KSK 150 FC Labeling, warnings, notes and symbols NOTE Observe the warning labels and signs! • If you notice that any label is missing on your device or has become illeg- R021 ible, please contact us or one of our authorized representatives. We will supply you with replacements.
  • Page 17 KSK 150 FC Safety Measures Version 7.1 G-30-1158-en Page 17...
  • Page 18 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. – SIP number A unique identification number assigned to your device.
  • Page 19 KSK 150 FC Safety Measures Version 7.1 G-30-1158-en Page 19...
  • Page 20 Safety Measures KSK 150 FC 13 Rating label The rating label provides the following information: Manufacturer's symbol Manufacturer (company name) Carl Zeiss Meditec AG Manufacturer's address Goeschwitzer Strasse 51-52 07745 Jena, Germany Serial number Device name KSK 150 FC Reference number...
  • Page 21 KSK 150 FC Safety Measures 14 15 16 Version 7.1 G-30-1158-en Page 21...
  • Page 22 Safety Measures KSK 150 FC Potential equalization If requested, the Coloscope KSK 150 FC can be included in the "potential equalization" safety measure. 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.
  • Page 23 KSK 150 FC System Overview System Overview Colposcope KSK 150 FC..............24 Features ....................24 Configuration features................24 Set-up, main groups ..................26 Controls, support unit................28 Controls, colposcope .................30 Instrument base..................33 Accessories for the microscope..............34 Version 7.1 G-30-1158-en Page 23...

  • Page 24: Colposcope Ksk 150 Fc

    KSK 150 FC Colposcope KSK 150 FC Features The Colposcope KSK 150 FC is a compact, manually operated, universal col- poscope for gynecology. Its hallmarks are its superb mobility and easy opera- tion. In the basic configuration, the Colposcope KSK 150 FC is equipped with: –...
  • Page 25 Numerous accessories are available for the colposcope and can be ordered to- gether with the device or as retrofitting components; please also see the sec- tion "Ordering data". You can find additional accessories in the "ZEISS video accessories" product overview (G-30-1888).

  • Page 26: Set-Up, Main Groups

    System Overview KSK 150 FC Set-up, main groups 1 Microscope for the Colposcope KSK 150 FC The colposcope has a compact, manually operated, universal microscope for the gynecologist. In its basic configuration, it is equipped with an inclined binocular tube with push-in widefield eyepieces, 5-step magnification changer and a cold-light illuminator.
  • Page 27 KSK 150 FC System Overview Version 7.1 G-30-1158-en Page 27...

  • Page 28: Controls, Support Unit

    System Overview KSK 150 FC Controls, support unit 1 "Instrument head" friction knob Locks the rotational movement of the instrument head. 2 "Inclination" friction knob Fixes the instrument head in any inclined position desired. 3 Handgrip To position the colposcope.
  • Page 29 KSK 150 FC System Overview Version 7.1 G-30-1158-en Page 29...

  • Page 30: Controls, Colposcope

    System Overview KSK 150 FC Controls, colposcope 1 Eyepieces The standard eyepieces feature 10x magnification. Alternatively, eye- pieces with a magnification of 12.5x are available. 2 Inclined binocular tube and eyepieces The 45° inclined binocular tube with a focal length of f = 170 mm is the standard tube.
  • Page 31 KSK 150 FC System Overview Version 7.1 G-30-1158-en Page 31...
  • Page 32 System Overview KSK 150 FC Widefield eyepieces with magnetic coupling NOTE Eyepieces have a magnetic field! Please keep in mind the usual rules for the handling of magnets with regard to eyepieces that have been removed from the tube: • Do not place the eyepiece near instruments that could be magnetizable.

  • Page 33: Instrument Base

    Special connecting tubes permit the connection of the colposcope to various types of examination chairs. For some common types of examination chairs, you can order the mounts from ZEISS, see the section on "Ordering data". Please contact the ZEISS subsidiary in your country.

  • Page 34: Accessories For The Microscope

    A beam splitter can be inserted between the microscope and the binocular tube. For example, ZEISS Service can insert the beam splitter "Splitter 20" with the directly flange-mounted 1Chip HD Camera. TV attachments with C-mount for an external video camera, an adapter for digital photography, or a coobservation tube can be connected to the beam splitter "Splitter 50".
  • Page 35 KSK 150 FC Preparations for use Preparations for use Instrument with stand (option)............38 Setting the working height of the support unit ..........38 Relocating the system................40 Attaching the equipment..............42 Binocular tube, eyepieces and objective lens, mounting......42 Changing microscope accessories ..............44 Setting the balance..................44...
  • Page 36 Preparations for use KSK 150 FC NOTE This equipment must not be modified without the manufacturer's approval! Your devices may not be modified without the manufacturer's approval. If R034 the system is modified after consultation with the manufacturer, suitable in- spections and testing must be completed to ensure subsequent safe use.
  • Page 37 KSK 150 FC Preparations for use Version 7.1 G-30-1158-en Page 37...

  • Page 38: Instrument With Stand (Option)

    Preparations for use KSK 150 FC Instrument with stand (option) Setting the working height of the support unit The required working height of the support unit can be set by the locking ring (3) on the column. CAUTION Risk of injury caused by lowering of the support unit!
  • Page 39 KSK 150 FC Preparations for use • Firmly tighten the friction knob for rotational motion (2) to lock the sup- port unit (1) on the stand column. • Loosen clamping screws (3) on the locking ring. • Push up the locking ring to the underside of the support unit and firmly tighten securing screws (3).

  • Page 40: Relocating The System

    Preparations for use KSK 150 FC Relocating the system VORSICHT Risk of crushing - mind your fingers! Fingers may be crushed in the areas marked with the "Risk of crushing" label. R067 • Do not touch these areas while the system is being moved or brought in its working / transport position.
  • Page 41 • Transport the device over long distances only in its original packaging or special return packaging. Please contact your dealer or ZEISS Service. Version 7.1 G-30-1158-en...

  • Page 42: Attaching The Equipment

    Preparations for use KSK 150 FC Attaching the equipment CAUTION Risk of injury caused by parts falling down! If components and accessories are mounted on or removed from the device R045 about the patient, which is not allowed, this can cause parts to fall, can cause injury to the patient, and can cause infections.
  • Page 43 • Place the binocular tube (2) on the colposcope body and tighten the se- curing screw (5) firmly. ZEISS Service can install the video accessories between the microscope body and the binocular tube for you: For example, the Splitter 20 can be installed with the 1Chip HD Camera (4).

  • Page 44: Changing Microscope Accessories

    Preparations for use KSK 150 FC Changing microscope accessories The colposcope accessories can be changed in reverse order to that described in "Attaching binocular tube, eyepieces and objective lens“. Please observe the following: • Turn off the unit at the power switch before changing any accessories.
  • Page 45 KSK 150 FC Preparations for use Version 7.1 G-30-1158-en Page 45...

  • Page 46: Connecting The System

    If this is not the case, you must not operate the system. • If there is a variance, ZEISS Service will have to convert your device to the line voltage available at your location.
  • Page 47 KSK 150 FC Preparations for use Connecting the potential equalization If requested, the Coloscope KSK 150 FC can be included in the "potential equalization" safety measure. An appropriate connection bolt must be provided in order to connect the Co- loscope KSK 150 FC to the potential equalization system, see Page 22.

  • Page 48: Setting The Colposcope

    Preparations for use KSK 150 FC Setting the colposcope Notes on adjustment – It is recommended to provide the interpupillary distance as well as the re- fraction values for the different users to adjust the colposcope more quick- ly and to preset the values in the scope of the preparation.
  • Page 49 KSK 150 FC Preparations for use • Repeat the entire procedure for the second eyepiece.  Now, the colposcope is adjusted in such a way that the image is sharply defined over the complete magnification range without any renewed fo- cusing during the magnification setting.

  • Page 50: Integrated Video System (Option)

    Preparations for use KSK 150 FC Integrated video system (option) WARNING Risk of electric shock caused by inadmissible or defective accessories! Inadmissible or defective accessories may lead to increased leakage current. The user and patient may suffer an electric shock if the video output ports are touched.
  • Page 51 KSK 150 FC Operation Operation Checklist ..................52 Support unit ....................52 Colposcope ....................53 Procedure ..................53 Causes of malfunctions and remedies..........56 Version 7.1 G-30-1158-en Page 51...

  • Page 52: Checklist

    • Correct the malfunction (see "What to do in the event of malfunctions“) or contact Carl Zeiss Service. • Always check the function of the system before examination or treatment (without patient!) using the following checklist.

  • Page 53: Colposcope

    KSK 150 FC Operation Colposcope  Check that the binocular tube is screwed on tightly to the colposcope body with the securing screw.  Check that the objective lens is screwed on tightly. • Turn on the device with the power switch of the suspension system.
  • Page 54 Operation KSK 150 FC CAUTION Risk of burns due to light intensity that is too high Due to the use of an additional beam splitter in the main observer beam path, R036 less light is available to the user in the eyepieces. However, to obtain the...
  • Page 55 KSK 150 FC Operation Starting work  All preparations for use have been completed.  The system has been checked using the checklist. • Switch on the power switch on the suspension system. • Move the suspension arm into its working position.

  • Page 56: Causes Of Malfunctions And Remedies

    What to do in the event of malfunctions KSK 150 FC What to do in the event of malfunctions Causes of malfunctions and remedies For your safety • This system is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance.
  • Page 57 KSK 150 FC Care and Maintenance Care and Maintenance Care of the device................58 Cleaning ....................58 Disinfection ....................59 System maintenance................60 Maintenance intervals................60 Safety check ....................61 Changing the halogen lamp ..............62 Changing the fuse ..................64 Disposal.....................65 Version 7.1 G-30-1158-en Page 57...

  • Page 58: Care Of The Device

    • Remove dust from the optical surfaces using a squeeze blower or a clean, grease-free brush. For the regular cleaning of objective lenses and eyepieces, we recommend the optics cleaning set available from Carl Zeiss. For the catalog number, please see the section "Device data". Prevention of fogging To keep the objective lenses from fogging, we recommend using an anti-fog- ging agent.

  • Page 59: Disinfection

    KSK 150 FC Care and Maintenance • Please observe the Instructions for Use supplied with each anti-fogging agent. Anti-fogging agents not only ensure fog-free eyepiece optics, they also clean the eyepiece optics and protect them from dirt, grease, dust, lint and finger- prints.

  • Page 60: System Maintenance

    All maintenance work not detailed here requires system-specific expert know- how. It is frequently necessary to open the system for this work. Please contact your local Carl Zeiss service representative in due time for the performance of these maintenance activities.

  • Page 61: Safety Check

    KSK 150 FC Care and Maintenance Safety check CAUTION Risk of electric shock! If cables and plug connections come loose, housing parts can come into con- R082 tact with live voltage. If the user or the patient touches these live housing parts, they can receive an electric shock.

  • Page 62: Changing The Halogen Lamp

    Care and Maintenance KSK 150 FC Changing the halogen lamp NOTE Risk of burns caused by hot lamp! If you change the lamp shortly after it has failed, the lamp will still be very R054 hot. There will be a risk of being burned! •...
  • Page 63 KSK 150 FC Care and Maintenance Version 7.1 G-30-1158-en Page 63...

  • Page 64: Changing The Fuse

    Care and Maintenance KSK 150 FC Changing the fuse The fuses are integrated in the power inlet socket for the power cable. To change a fuse, proceed as follows: • Turn off the system at the power switch. • Unplug the power cord from the wall outlet.

  • Page 65: Disposal

    KSK 150 FC Care and Maintenance Disposal User information on the disposal of electrical and electronic devices This symbol means that the product must not be disposed of as normal do- mestic waste. The correct disposal of electrical or electronic devices helps to protect the en-...
  • Page 66 Care and Maintenance KSK 150 FC Version 7.1 Page 66 G-30-1158-en...
  • Page 67 Electromagnetic immunity for all ME equipment and ME systems..................79 Electromagnetic interference resistance for ME equipment or systems that are not life-sustaining............80 Recommended safety distances between portable and mobile RF communication equipment and the KSK 150 FC ........82 System combinations...............83 Version 7.1 G-30-1158-en Page 67...

  • Page 68: Technical Data

    KSK 150 FC Technical data Key features KSK 150 FC KSK 150 FC Has no key features within the meaning of IEC 60601-1: 2005 + A1:2012. The fundamental functions within the meaning of the intended use were tested by the manufacturer for their stability.
  • Page 69 KSK 150 FC System Data Component Properties Illumination equipment Lamp housing in carrier arm: Halogen reflector lamp 12 V 100 W, manual lamp change. An integrated fiber optic system (light guide) directs the light to the colposcope. Power connection Power connector on carrier arm: Only connect the device to wall outlets which are properly equipped with a protective ground conductor.

  • Page 70: Ordering Data

    KSK 150 FC Ordering data Only operate the system with the accessories included in the delivery package and approved by Carl Zeiss. You will find the contact responsible for orders in your country on this website: www.meditec.zeiss.com Colposcope KSK 150 FC, consisting of:...

  • Page 71: Accessories

    • Only use the accessories included in the delivery package. • Use the accessories included in the delivery package only for the described intended purpose. • Please send your orders to your local contact of the ZEISS subsidiary in your country. Tubes Description Cat.
  • Page 72 System Data KSK 150 FC Objective lenses Description Cat. No. Objective lens f = 300 mm 302305-9030-000 for Colposcope 130 / 150 FC Objective lens f = 250 mm 302305-9025-000 for Colposcope 130 / 150 FC Cleaning agents Description Cat. No.

  • Page 73: Option 1Chip Hd Camera, Integrated Hd Video

    System Data Option 1Chip HD Camera, integrated HD video Description Order number 1Chip HD Camera with beam splitter – 1Chip HD Camera - KSK 150 FC 301900-8100-000 – System cable DVI-D, 5 m 302681-8767-000 – Splitter 20 (beam splitter 20)
  • Page 74 302681-8767-000 – Splitter 20 (if customer does not have) 301503-9901-000 For "1Chip HD Camera" option, ZEISS supplies the Instructions for Use "1Chip HD Camera" (G-30-1946) automatically. Video accessories You can find additional video accessories in the "ZEISS video accessories" product overview (G-30-1888).

  • Page 75: Spare Parts

    KSK 150 FC System Data Spare parts Description Order number Halogen lamp, 12V, 100W 380079-9040-000 Line fuse, fusible element You need two each! – For 100 V - 127 V: T 2,00A H 250 V 5x20mm 000000-0149-688 – For 220 V - 240 V: T 0,80A H 250 V 5x20mm 000000-0149-684 Version 7.1...

  • Page 76: Regulatory Information

    System Data KSK 150 FC Regulatory information Approvals and requirements Description Labeling Electrical safety The medical device complies with the requirements – IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012 – IEC 60601-1:2005 + A1:2012 – CAN/CSA-C22.2 No. 60601-1:2014...

  • Page 77: Environmental Conditions

    KSK 150 FC System Data Environmental conditions For operation Feature Permissible range Temperature + 10°C ... + 40°C Rel. Humidity 30% ... 75% Air pressure 700 hPa ... 1060 hPa For transportation and storage Feature Permissible range Temperature Without 1Chip HD Camera: - 40°C ...

  • Page 78: Emc (Electromagnetic Compatibility)

    Instructions for Use, do not operate the device in direct proximity to other devices. • Only use accessories, transformers, cables and spare parts which are specified in these Instructions for Use or which are approved by ZEISS for this device. • Do not use any portable or mobile RF communication equipment near the device as it is not possible to exclude the possibility that the function of the device will be affected.

  • Page 79: Electromagnetic Interference

    Electromagnetic interference The KSK 150 FC is intended for operation in an electromagnetic environment as specified below. The customer or the user of KSK 150 FC is responsible for ensuring that the device is operated in such an environment. Interference measure-...

  • Page 80: Electromagnetic Interference Resistance For Me Equipment Or Systems That Are Not Life-Sustaining

    The device KSK 150 FCis intended to be operated in one of the electromag- netic environments specified below. The customer or the user of the device KSK 150 FC is responsible for ensuring that it is operated in such an environ- ment.
  • Page 81 Tests Portable and mobile radio communication equipment should not be used closer to the de- vice KSK 150 FC, including cables, than the rec- ommended safety distance that is calculated using the equation applicable to the transmis- sion frequency involved.

  • Page 82: Recommended Safety Distances Between Portable And Mobile Rf Communication Equipment And The Ksk 150 Fc

    KSK 150 FC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equip- ment (transmitters) and the KSK 150 FC - depending on the output power of the communication equipment as specified below.

  • Page 83: System Combinations

    System Data System combinations The Colposcope KSK 150 FC can be extended with the accessories offered by Carl Zeiss Meditec A (see ordering data for accessories) to form an already tested system. Then this system combination is approved by ZEISS.
  • Page 84 System Data KSK 150 FC Version 7.1 Page 84 G-30-1158-en...
  • Page 85 Changing accessories ................44 Changing the fuse ..................64 Changing the halogen lamp ..............62 Checklist ....................52 Colposcope floor stand ................33 Colposcope KSK 150 FC ..............24, 26 Colposcope, controls ................30 Configuration features ................24 Connecting the device cable ..............46 Connecting the potential equalization ............47 Connecting the system ................46...
  • Page 86 Device base ..................24, 26 Diopter scale .....................32 Diopter setting ring ...................32 Disposal ....................65 Documentation equipment ...............42 Dust cover, blue, with ZEISS logo ..............70 EMC (electromagnetic compatibility) ............78 Ending work .....................55 Examination chair, connecting tube for .............33 Eyecups ....................32 Eyepieces ..................24, 30, 34 Eyepieces, attachment ................42...
  • Page 87 Integrated video system (option) ..............50 Intended use ....................7 Interchangeable objective lens ..............30 Interchangeable objective lenses ..............34 Key to symbols ...................6 KSK 150 FC basic model ................70 Lastverteilung, symmetrisch ..............69 Liability and warranty .................8 Light source, halogen ................24 Line fuses ....................64 Load ......................69...
  • Page 88 Index KSK 150 FC Objective lens, attachment ................42 Observe the rated voltage .................46 Optical surfaces, cleaning .................58 Order number ...................70 Ordering data ...................70 Performance features ................68 Potential equalization .................10, 22 Power connection ..................69 Power consumption ..................69 Power outlet with connected protective earth conductor ......46 Power switch with power display ..............28...
  • Page 89 KSK 150 FC Index Tubes .......................34 Universal colposcope ................24 Video and camera equipment ..............34 Voltage setting ..................46 Weight .....................68 Widefield eyepieces in mount in the binocular tube ........42 Widefield eyepieces with magnetic coupling ..........32 Version 7.1 G-30-1158-en Page 89...
  • Page 90 Index KSK 150 FC Version 7.1 Page 90 G-30-1158-en...
  • Page 91 KSK 150 FC (Blank page, for your notes . . .) Version 7.1 G-30-1158-en Page 91...
  • Page 92 Carl Zeiss Meditec AG Fax: + 49 (0)7364 - 20 4823 Goeschwitzer Strasse 51-52 Email: surgical@meditec.zeiss.com 07745 Jena Internet: www.meditec.zeiss.com Germany...

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