S100 and OPMI 1-FC User Manual Version 3.2

S100 / OPMI® 1-FC

About this manual

Orientation aids

Applicable area

The user manual is part of the delivery package. •

Carefully read it before using the device.

•

Keep it at the site of use of the device.

•

Store it for the entire service life of the device.

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Pass it on to every subsequent owner or user of the device.

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The chapter overview at the beginning of the user manual provides a summary of all subjects.

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The contents of each chapter are specified in detail at the beginning of each chapter.

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A list of abbreviations, key words and technical terms in the annex facilitates the search for specific terms.

This user manual applies to OPMI® 1-FC on S100 suspension systems with the following identification: Configuration

REF. no. ®

Trademarks

Manufacturer

S100 (floor stand) / OPMI 1-FC

000000-1403-542

S100 (wall mount) / OPMI® 1-FC

000000-1403-544

S100 (ceiling mount) / OPMI® 1-FC

000000-1403-572

OPMI® is a registered trademark of Carl Zeiss. 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 2011 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, this manual 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

37

Chapter:

Preparations for use

59

Chapter:

Operation

87

Chapter:

What to do in the event of malfunctions

95

Chapter:

Care and Maintenance

101

Chapter:

System Data

111

Chapter:

Indexes

135

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S100 / OPMI® 1-FC

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Safety Measures

Key to symbols ... 6 Hazard symbols ...6 Information symbols...6 Target group ... 7 Field of use ... 8 Intended use ...8 Normal use...8 Notes for the operator... 10 Requirements for operation... 12 Prior to the very first use...12 Before every use ...12 During use...13 After every use ...14 Warranty and liability...14 Risk of burn injuries caused by high illumination intensity ... 15 Safety devices... 17 Symbols and labels on the device ... 18 Symbols on the S100 floor stand ...18 Symbols on the S100 wall mount ...24 Symbols on the S100 ceiling mount...28 Symbols on the illumination unit...32

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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 user manual. 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 this user manual: –

Listing

 Prerequisite for an action •

Prompt for action

 Result of an action Additional information and tips

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Safety Measures

Target group

CAUTION

Operation by trained personnel only! This user manual is intended for physicians, nurses and other medical staff who prepare, operate or maintain the system after appropriate training. It is the duty of the customer or institution operating the system to train and instruct all staff using the system. Installation and service work not described in this manual must only be performed by specialists from Carl Zeiss.

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Field of use Intended use OPMI 1-FC is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures.

Normal use In line with the intended use of the system, you can use OPMI 1-FC for various applications, e.g. as –

surgical microscope,

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diagnostic microscope,

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training and dissecting microscope.

The OPMI 1-FC surgical microscope is mounted on S100 suspension systems via a 120° coupling. The 120° coupling makes the instrument ideal for ENT applications. The suspension arm and its adjustable brake function enable you to balance the suspension system in such a way that the surgical microscope can be safely positioned. The system-integrated halogen illumination delivers a sharply defined, highcontrast image of the working area. A light guide directs the light to the illumination system of the microscope. The 5-step magnification changer allows the surgeon to set the magnification required. Fine focusing is made via a drive knob on the microscope body. To change the viewing direction, you can continuously swivel the surgical microscope about its horizontal axis. The friction of the lateral tilt motion and the fine focusing can be set to the weight of the microscope equipment. The surgical microscope can be supplemented by various accessories and can be prepared for sterile use by attaching resterilizable caps and drapes. Three S100 suspension system versions are available for OPMI 1-FC:

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Floor stand, optionally with documentation equipment, mounted on an instrument tray and with a touchscreen with flat screen monitor bracket.

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Wall mount

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Ceiling mount

The system is intended for use in offices, hospitals or other human medicine institutions. For disposal, please observe the instructions in this manual as well as the applicable legal regulations in your country.

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Notes for the operator

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•

Please thoroughly familiarize yourself with the contents of the user manual before starting up the system. Also observe the user manuals for accessories and other system components.

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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 the user manual where it is easily accessible at all times for the persons operating the system.

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Please observe all symbols and labels attached to the device! (see page 18)

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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 system must not be modified without the manufacturer's approval. If the system is modified, suitable inspections and testing must be completed to ensure that it can still be used safely. 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.

•

Modifications and repairs of this device or any equipment operated together with this device may only be performed by Carl Zeiss service staff or other persons authorized by Carl Zeiss.

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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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Make sure that the installation conditions and the use of the device meet surgical requirements: See Ambient conditions on page 133

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Do not use any power-operated device that is part of the delivery scope –

in explosion-hazardous areas,

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do not operate the device close to flammable anesthetics or volatile solvents, such as alcohol, ether/benzene or similar. Stay away at least 25 cm.

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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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Do not use multiple sockets!

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Never open the device! The device contains freely accessible live components. If you remove the housing, you run the risk of electric shock.

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Do not touch the system if your body is electrostatically charged and the system is not grounded.

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Please note the information on EMC (electromagnetic compatibility) in the chapter "System data" on page 117.

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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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Switch off the unit at the power switch if you notice any smoke, sparks or unusual noise. Do not use the unit until it has been repaired by our service team.

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Fingers may be crushed between the monitor and carrier arm. Never touch this area while moving the monitor.

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Should the device be transported over longer distances (e.g., moving, return for repairs etc.), only use the original packaging or special return packages. Please contact your dealer or the Carl Zeiss Service department.

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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").

Any additional equipment connected to medical electrical devices must demonstrably comply with the applicable standards and directives (e.g. EN 60950:2005 for data processing equipment). In addition, all configurations must meet the normative requirements for medical systems (see EN 60601-11:1990 or Clause 16 of the 3rd edition of EN 60601-1:2006 respectively). Anyone connecting additional equipment to medical electrical devices is a system configurer and as such responsible for compliance of the system with the normative requirements for systems. 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.

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Safety Measures

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Requirements for operation Prior to the very first use Carl Zeiss Service or a person authorized by Carl Zeiss 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 plugs are in perfect condition.  Determine the supply voltage at the place of installation and set the voltage of the device accordingly.  Insert the power plug only into a socket that is fitted with a flawless protective earth conductor.  The device is connected with the power cord supplied.  The device is connected to line power via galvanic separation.

Before every use

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When adding accessories and/or components please ensure the permissible total weight of the device is not exceeded. (see label "Maximum load" or Section "Technical Data").

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Before every use, perform the balancing procedure to enable the surgical microscope to maintain its balance in all positions of the working range.

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Check the surgical microscope for sufficient freedom of movement. The device itself or accessories may be damaged if conflicting with each other.

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Before every use, make sure that all components and accessories are securely locked in position.

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Always run cables in a manner that will not impede the user's movements.

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Only use the device with properly fitting and sterile accessory tools.

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Never cover any ventilation openings, as the light source of the system switches off in the event of overheating.

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•

Never attempt to forcefully connect any electrical connectors (plugs, sockets). If connection is not readily possible, check whether the plug fits the socket. If any of the connectors are damaged, have the Carl Zeiss service team repair them.

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Use the brake tabs on the casters to lock the floor stand in position so that it cannot roll away by itself.

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Go through the checklist in the chapter "Operation".

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Reduce the brightness and duration of light exposure of the surgical area to the absolute minimum level required to avoid burn injuries.

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In order to prevent phototoxic damages, never look directly into the light source, e.g. on the microscope or the light guide.

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Never leave a device unattended with the light source still switched on.

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Defective or unidentified accessories may lead to increased leakage current. Never connect any defective or unidentified accessories.

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Never contact video interfaces while in contact with the patient.

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Caution! If replacing the lamp shortly after it failed, it can still be extremely hot. Use heat-resistant protective gloves when replacing the lamp.

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If the halogen lamp is used beyond its maximum service life of 50 hours, sudden failure may occur and interrupt operation. Please replace the halogen lamp in due time.

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Do not pull at the power cord or any other connecting cables.

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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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Never operate the system unattended.

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Always switch off the system - before disconnecting it from / connecting it to line power - if it will not be used for a prolonged period of time - or for cleaning purposes.

During use

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Safety Measures

S100 / OPMI® 1-FC

After every use •

Always use the master switch to turn off the device if it is not in use.

•

Insufficient, faulty or wrong methods of cleaning or not disinfecting the device according to this instruction manual may severely increase the risk of infecting the patient and/or medical personnel.

Warranty and liability Warranty and liability depend on the applicable contractual stipulations. NOTE

Loss of warranty No modifications may be made to this system without the manufacturer's approval. If the system is modified, suitable inspection and testing must be completed to ensure that it can still be used safely. The manufacturer accepts no liability for damage caused to the device as a result of unauthorized modifications. The warranty also becomes null and void.

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Risk of burn injuries caused by high illumination intensity

CAUTION

Risk of burns caused by high light intensity If the illumination system is used improperly, excessive illumination intensities may lead to third-degree burns. •

Please read and note the following points.

General The risk of burns is influenced by several different factors: System-related factors: –

The wavelength range is limited by filters to the visible range between 400 nm and 700 nm. These filters remain stable over a very long period of time and cannot be exchanged by the user.

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With increasing service life of the lamp, the actual illumination intensity delivered at the respective setting decreases. When the lamp is finally replaced, the illumination intensity increases again to the high, original value.

Surgery-related factors:

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–

The selected intensity of the light source is a major factor for the risk of injury. It should always be set to the minimum required for the surgical procedure to be performed.

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A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual.

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Injuries in the peripheral area can be prevented by covering this area with wet, sterile gauze. The gauze must be moistened at regular intervals to avoid that the area dries out or heats up.

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You should also take into account that some areas of the body may be more sensitive than others.

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Certain preparations of the surgical field, local vasoconstrictive medications and incision drapes may also result in a higher risk of injury (drapes may heat up by different amounts depending on their color and moisture content).

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Safety Measures

S100 / OPMI® 1-FC

Patient-related factors: –

The general condition of a patient's health may contribute to the risk of injury.

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The skin type may also play a major role in this respect.

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Certain medications affect the sensitivity to light.

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The interaction of heat and antimicrobial substances in incision foils may lead to an increased reaction of the patient to these substances.

Recommendations Due to the large number of different factors involved and the lack of scientific publications on this topic, Carl Zeiss cannot provide guidance on acceptable intensities and exposure durations. However, this system has several features that can help the user to reduce the risk of burns. –

The start value of the light intensity can be set to a low value.

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The risk of burns can be reduced by constantly irrigating the illuminated surgical field and by keeping it moist.

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If patient drapes are used, they should also be moistened at regular intervals to prevent the build-up of heat under the drape.

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Switch off the light when the microscope is not used, and make sure that it is not pointed at unprotected bare skin.

Please note that most burns affected the skin around the incision. The most important measure to avoid burns is covering the peripheral area with wet, sterile gauze. The area of the incision should be constantly irrigated.

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Safety Measures

Safety devices Halogen illumination system 1 Flap The flap is the mechanical indicator for the operating status of the halogen lamps. –

When the flap is closed, the main lamp is operative.

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When the flap is open, the main lamp has failed. The backup lamp is on.

2 Switching to the backup lamp The lamp housing contains a backup lamp. If the first lamp fails, you can switch on the backup lamp by pressing this button. Fig. 1: Safety device of halogen illumination system

1

2

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Symbols and labels on the device

CAUTION

Observe all warnings and information labels! •

If you notice that any label is missing on your device or has become illegible, please contact the Carl Zeiss service department.

Symbols on the S100 floor stand 1 Friction symbol Explanation of how to change the brake effect using the friction adjustment knob. Left position: light brake effect Right position: strong brake effect 2 "Risk of crushing" warning label Fingers may be crushed. Do not touch this area while moving the surgical microscope or parts of it.

3 Brightness control If the illumination system is on, you can continuously adjust the brightness of the fiber illumination by turning this knob. –

Left position: minimum brightness

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Right position: maximum brightness

4 "Maximum load" warning label The maximum load on the suspension arm must not exceed 7 kg. max. 7 kg

5 Balancing of the suspension arm After all accessories have been attached to the surgical microscope, this adjustment screw can be used to balance the suspension arm.

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Fig. 2: Symbols and labels on the S100 floor stand

1

1

2 1

2

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5

1 2

2

3

4

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Safety Measures

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6 SIP label The SIP label contains the following information:

XXXX XXXXXX

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Manufacturer (company name)

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Manufacturer's contact data, 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 number A unique identification number assigned to your system. A product file is maintained by Carl Zeiss for this SIP number.

7 System identification label The system identification label provides the following information: –

Manufacturing symbol

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Manufacturer (company name)

Carl Zeiss Meditec AG

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Manufacturer's address

Goeschwitzer Strasse 51-52 07745 Jena, Germany

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Serial number

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Project classification

P30200001

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System name

S100 (OPMI 1-FC)

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Reference number

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CSA mark

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CE label

8 Year of manufacture This label indicates the year of manufacture of the device.

9 "Transport position" label Always hold the stand at the indicated point for transportation. Observe the user manual or accompanying documents. Indicates the transport position of the system. Before transporting the system, make sure that it is in this position in order to avoid any damage.

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