uniPORT Operating Instructions March 2013

Thank You Very Much

for purchasing the uniPort® Ceiling Support System. Please read these Operating Instructions very carefully, abide by the safety notices and observe all operating and cleaning requirements. These Operating Instructions apply to the following devices • uniPort® Ceiling Support Systems with horizontally swivelable base support units of the following types: 1108 x 1518 x 1528 x 1538 x 1548 x 1558 x 1568 x 1328 x

1378-1 x 1378-2 x 1578 x 1588 x 1589 x 1590 x 1598 x

(x indicates a device-specific variant designation) • uniPort® Ceiling Support Systems with electrically height adjustable and horizontally swivelable base support units of the following types: 1708 M x 1808 M x 1908 M x 2008 M x 2108 M x (x indicates a device-specific variant designation)

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How to Contact Us

Customer service is at your disposal • if you have questions about the device and its installation, • to reorder spare parts, • in service or warranty cases. Manufacturer and marketer TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 D-07318 Saalfeld Germany

Germany

Sales

Customer service Inquiries from Germany

Customer service Inquiries from abroad E-mail Visit us on the Internet

How to contact us TRUMPF Medizin Systeme GmbH + Co. KG Benzstraße 26 D-82178 Puchheim Germany Phone: +49 / (0)89 / 8 09 07 - 0 Fax: +49 / (0)89 / 8 09 07 - 40 222 Phone: 0 180 / 2 25 41 35 Chargeable phone call: – 6 ct/call from German landline – 42 ct/minute (max.) from mobile phones Fax: +49 / (0) 36 71 / 586 - 41 175 Phone: +49 / 36 71 / 586 - 0 Fax: +49 / (0) 36 71 / 586 - 41 175 [email protected] www.trumpf.com www.trumpf-med.com

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Notes Relating to this Documentation

Copyright

Modifications to the device Modifications to the Operating Instructions

Translations

Copyright and property rights All rights reserved. These Operating Instructions are protected by copyright law. • Any other use than those regulated by law must be approved in writing by TRUMPF Medizin Systeme GmbH + Co. KG, hereinafter referred to as TRUMPF. • TRUMPF does not take any liability for or in relation to the misuse of this information in the prohibited manner by any person or company. Modifications and translations Since our products are subject to continuous further development, we reserve the right to modify the form, equipment and technology of our scope of supply. • The contents of these Operating Instructions are subject to change without prior notice. • Please obtain information on the current version of the operating instructions at regular intervals, e.g. via the TRUMPF Online Information System (OIS). • In case of translations into foreign languages, the German version of these Operating Instructions shall take precedence. Trademarks uniPort® is a registered trademark of TRUMPF. • All trademarks mentioned in these Operating Instructions are the sole and exclusive property of the corresponding manufacturer.

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Table of contents

1

Important Information for Safe Use ... 8 1.1 Information for identification of the device ...8 1.2 How to identify the Operating Instructions...8 1.3 Identification of target groups ...8 1.3.1 Operator ...8 1.3.2 User...9 1.3.3 Qualified personnel ...9 1.4 Notes for the operator ...9 1.4.1 Initial commissioning ...9 1.4.2 Availability of these Operating Instructions ...9 1.4.3 Warranty...9 1.4.4 Maintenance and repair ...10 1.4.5 Service life of the device ...10 1.5 Delivery ...10 1.5.1 Damage in transit ...10 1.5.2 Address for returns...10 1.6 Notes for the user...11 1.6.1 Instruction on the device ...11 1.6.2 User's duty to inform and inspect ...11 1.7 Intended purpose of the device ...11 1.7.1 Marking ...11 1.7.2 Standards and guidelines...11 1.7.3 Normal use...12 1.7.4 Special conditions to be considered during operation...12 1.7.5 Incorrect use ...12 1.7.6 Contraindications ...13 1.8 Ambient conditions for operation and storage ...13 1.8.1 Ambient conditions for operation...13 1.8.2 Ambient conditions for storage...13 1.9 Combined use with other medical devices ...13 1.10 Disposal...13

2

Safety Instructions... 14 2.1 Structure of the safety information in these Operating Instructions...14 2.1.1 Warnings of risk of injury ...14 2.1.2 Warnings of damage to property...14 2.1.3 Indication of additional information...14 2.2 Graphic symbols complementing the safety instructions ...14 2.3 Graphic symbols on the device ...15 2.4 Overview of the most important safety instructions ...15

3

Technology of the Ceiling Support System... 19

4

Identification of the Ceiling Support System ... 20 4.1 Identification of the components...20 4.1.1 Serial number of the complete ceiling support system...20 4.1.2 Serial number of the base support unit ...20 4.1.3 Serial numbers on the system head...20

5

Device and Functional Descriptions ... 21 5.1 Device description ...21 5.1.1 System heads and accessories ...23 5.1.2 Other accessories ...23 5.2 Functional description ...25

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Table of contents

5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6

6

Start-up ... 29 6.1 6.2

7

Range of action and end stops ...25 Function and effect of the joint brakes ...25 Function of the height adjustment mechanism...26 Power supply...26 Gas supply ...26 Loading the system head ...27

Initial commissioning ...29 Commissioning for medical operation ...29

Operation ... 31 7.1 Operating the friction brakes ...31 7.2 Operating the pneumatic brakes ...31 7.3 Height adjustment of the swivel arm ...33 7.4 Executing travel motions ...35 7.4.1 Positioning of the system head ...35 7.4.2 Positioning of the base support unit ...35

8

Cleaning and Disinfection ... 37

9

Inspection, Maintenance and Repair ... 40 9.1 9.2 9.3

Inspections during operation ...40 Inspection and maintenance intervals ...41 Replacement of parts subject to wear and tear ...43

10 Adjustments ... 44 10.1

Positioning attachment parts ...44

11 Technical Data ... 46 11.1 11.2

Device data ...46 EMC information...48

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1 Important Information for Safe Use

1.1

Information for identification of the device

These Operating Instructions are intended solely for devices with the manufacturer's rating plate bearing the following information: – Device designation: – Device with serial no. (or higher): Type designation:

Device identification

uniPort® 101390111 1108 x 1518 x 1528 x 1538 x 1548 x 1558 x 1568 x 1328 x 1378-1 x 1378-2 x 1578 x 1588 x 1589 x 1590 x 1598 x 1708 M x 1808 M x 1908 M x 2008 M x 2108 M x

(X indicates a device-specific variant designation)

1.2 Make sure you are using the latest version

How to identify the Operating Instructions

To ensure that you always have the latest version of these Operating Instructions, all pages bear a 7-digit identity number with a 4-digit version number and country code: – Edition: – Version:

Identification of these Operating Instructions

7200601_02_04 US 01/03/2013

This identification is binding for the validity of the Operating Instructions and must not be removed, regardless of the type of publication (printed form, electronic form or excerpts).

1.3

Identification of target groups

The following groups of persons are mentioned in these Operating Instructions: 1.3.1 Operator • Any natural person or legal entity who owns the device or regulates its use or in whose behalf the device is used is referred to as the "operator" (medical practice, hospital, etc.). • The operator shall be liable for handing over a safe device and for instructing the user in its proper operation and normal use. 7200601_02_04 US Operating Instructions uniPORT | 01/03/2013

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1 Important Information for Safe Use

1.3.2 User • Users a persons who, due to their professional qualification or proper instruction by qualified personnel, are authorized to operate the device and work with it. • Users shall be fully responsible for the safe operation of the device in accordance with its intended purpose. 1.3.3 Qualified personnel Any authorized person, usually employees of the operator, and: • persons who underwent special professional training in the field of medical engineering, • persons who can assess their work and recognize the potential hazards involved on the basis of their professional experience and instruction in safety-relevant regulations. • In States where job activities in the medical engineering sector are subject to certification, qualified personnel must have obtained the corresponding certificate.

1.4 Procedural guidelines

Validity

Duty to inform

Warranty

Notes for the operator

Although the device has been designed according to the state of the art and is safe to operate, • it must be considered a potential source of danger, in particular when operated by insufficiently trained personnel or used improperly and not as prescribed. • The device may only be operated, cleaned, disinfected and maintained by qualified personnel. 1.4.1 Initial commissioning These Operating Instructions only apply after proper initial commissioning by the operator or the manufacturer's authorized installer. • Only Ceiling Support Systems may be put into operation whose gas and power supply equipment has been checked and which have been released for operation by means of a declaration of acceptance! • As soon as the device has been released for operation, the instructions provided in these Operating Instructions are binding for the user. • Warning signs which warn against potential dangers during installation may only be removed after the device has been released for operation. 1.4.2 Availability of these Operating Instructions • Since these Operating Instructions are an integral part of the device, they must always be kept near the device in order to be able to look up safety instructions and important information on use at any time. • Do not pass on the device to any third party without valid Operating Instructions. Based on the ID and version numbers, make sure that you hand over an up-to-date and valid version of the Operating Instructions together with the device. 1.4.3 Warranty TRUMPF guarantees the safety and functional reliability of the device only on condition that: • The device is used exclusively as prescribed and operated, maintained and repaired as stipulated in these Operating Instructions; • only genuine spare parts and accessories authorized by TRUMPF are used; • no structural alterations are made on the device; • inspections and maintenance are carried out at the specified time intervals; • initial commissioning has been carried out and the device has been released for operation by means of a declaration of acceptance.

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1 Important Information for Safe Use

1.4.4 Maintenance and repair Maintenance and repair work on this device or on parts thereof must be carried out by: • TRUMPF customer service, • authorized service companies trained by TRUMPF, • service personnel of the operator which has been trained and authorized by TRUMPF. 1.4.5 Service life of the device Provided that all applicable safety and maintenance instructions are strictly adhered to, TRUMPF products are designed for a service life of 10 years. • This service life includes functionality, provided that the product is used in accordance with the specifications in the Operating Instructions, the provision of service and also spare parts supply. • TRUMPF subjects all of its corporate processes to a quality management system certified in accordance with DIN EN ISO 13485. • This ensures: – top quality, – convenient operation, – functional design, – optimization for the intended use.

1.5

Delivery

Prior to installation, inspect the delivered components for completeness and damage that may have occurred in transit. • To inspect the delivery, all components must be unpacked and subjected to visual inspection. • The components can be identified by means of the order number indicated on the shipping note and /or the order-specific dimension sheet.

Damage claims

Accompanying documents

Returns

1.5.1 Damage in transit Damage claims can only be considered if TRUMPF is notified immediately. In case of damage in transit or shortages, a damage report including the following information must be forwarded to TRUMPF: • Damage report providing information on the damages or defects, • Main serial number of the device/system or serial numbers of the damaged components, • Order number (as specified on the shipping note and/or order-specific dimension sheet), • Name and address of customer, • Consignee. 1.5.2 Address for returns To return an item, use the original packaging if possible. Returns must be sent to the following address: TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 D-07318 Saalfeld Germany

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1 Important Information for Safe Use

1.6

Notes for the user

Only properly instructed persons may operate this device.

Instruction

Troubleshooting

1.6.1 Instruction on the device • The instruction by qualified personnel of the operator or by the manufacturer's authorized installer must be carried out immediately on the device. • On completion of the instruction, a certificate must be created and signed in order to document that the user has understood the special operator control actions required for normal use. 1.6.2 User's duty to inform and inspect Read these Operating Instructions carefully prior to initial use of the device. This ensures that you benefit from all the advantages of the appliance and prevents any risk of injury or damage to property. • Prior to any use or transfer for use, the functional reliability and proper condition of the device must be inspected by the user. • In case of special problems which are not sufficiently described in detail in these Operating Instructions, contact your supplier for your own safety.

1.7 Conformity

Intended purpose of the device

1.7.1 Marking The manufacturer declares that this product complies with the basic requirements of MDD Appendix I and shows conformity by means of the CE and UL mark. CE mark: This device is a Class IIb Medical Device in accordance with the European Medical Device Directive (MDD 93/42/EEC, 2007).

UL mark

UL marking: device tested by Underwriter Laboratories Inc. for use in the USA and Canada with respect to electric shock, fire and mechanical hazards.

1.7.2 Standards and guidelines The device complies with the safety requirements of the following standards and diretives: • MDD 93/42/EEC, 2007 - Medical Device Directive; • EN 60601-1: 2006 (IEC 60601-1: 2005) - General Requirements for Basic Safety and Ergonomic Design; • EN 60601-1-2: (IEC 60601-1-2:2007) - Medical Electrical Equipment Electromagnetic Compatibility; • EN ISO 11197: 2009 Medical Supply Units; • EMC Directive; 2004/108/EC - Electromagnetic Compatibility (of Electrical and Electronic Equipment) for electrical equipment for measurement, control and laboratory use.

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1 Important Information for Safe Use

UL/cUL classification: • ANSI/AAMI ES60601-1 (2005, 3rd ed.) • CAN/CSA C22.2 No. 601.1 - M 90, 2005 Combined use with other medical devices: • IEC 60601-1 • IEC 60601-1-1 • UL 60601-1

Supply interfaces

Pick-up attachments

Working range

Modes of operation

Incorrect use

Restriction

1.7.3 Normal use The ceiling support system does not include any application parts with respect to its intended medical use. The Ceiling Support System serves as a mobile supply interface for power consumers and also for the accommodation, deposit and storage of medical devices and accessories. • As a supply interface for power consumers, the ceiling support system head is configured with customer-specific outlet points for different media: heavy current, low current, medical gases, vacuum and compressed air. For more detailed information on the proper use of these outlet points, refer to the separate instruction documents of the corresponding manufacturer/supplier. • Only the pick-up attachments (platforms, device holders, etc.) attached to the system head may be used for picking up loads. To this end, the different loading conditions of the overall system and the individual attachments must be considered: – The load bearing capacity of the ceiling support system is defined by the maximum equipment load. When attaching pick-up attachments, the equipment load is reduced by the own weight of the attachments. – The load capacity of the individual pick-up attachments (platforms, device holders, etc.) is restricted to the separately indicated maximum load capacity. • The system head can be freely positioned in the room within the defined operating range of the pendant arms. • Any use exceeding the conditions specified above shall be considered as incorrect use (misuse). The user or operator shall be exclusively liable for any damage arising from incorrect use. 1.7.4 Special conditions to be considered during operation • Base support units consisting of horizontally swivelable arms only are suitable for continuous operation. • The base support units, which are height adjustable via an electric motor, operate in intermittent mode. • If the motor's thermal protection mechanism (overheating control device) trips due to a safety problem, the height adjustment feature is deactivated during the cooldown phase. 1.7.5 Incorrect use • The maximum load capacity of the individual pick-up attachments and the maximum equipment load of the Ceiling Support System must not be exceeded. • Apart from device-specific pick-up attachments (sub-pendant, platforms, device holders and genuine attachments), no additional load carriers may be installed and no additional loads may be attached. • The base support unit and the system head must not be exposed to strong leverage forces or vibration. • The base support unit must not be swung backwards and forwards or subjected to strong vibration. • Sitting down and remaining seated on platforms is not permitted. • The system must not be used near strong magnetic fields. • The Ceiling Support System is not suitable for use in environments containing

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1 Important Information for Safe Use

inflammable mixtures of anesthetics with air, oxygen or nitrous oxide. If such high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide occur in the environment of the device, there is a risk of ignition under certain conditions. In accordance with EN 11197, the hazardous area includes an area between 5 cm and 25 cm from the gas leak point. 1.7.6 Contraindications No contraindications have been found.

1.8

Ambient conditions for operation and storage

Different conditions are required for the operation and interim storage of the device. 1.8.1 Ambient conditions for operation • Ambient temperature: 10 °C to 40 °C; • Relative humidity: 30 % to 75 %; • Atmospheric pressure: 700 hPa to 1,060 hPa; • Operating altitude: up to 3,000 m above sea level. 1.8.2 Ambient conditions for storage • Ambient temperature: -15 °C to 60 °C; • Relative humidity: 5 % to 95 % • Atmospheric pressure: 500 hPa to 1,060 hPa.

1.9 Read the Operating Instructions for combined medical products

The system can be equipped with further medical devices from other manufacturers. For the operation of these devices, please refer to the respective Operating Instructions. • Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1 may be attached to the system. If a medical device is installed afterwards, the installation must be performed in accordance with IEC 60601-1 and IEC 60601-1-1 and in accordance with the manufacturer's instructions. Compliance with these instructions must be ensured by the operator. • The medical products must comply with the ambient conditions for operation and storage.

1.10

RoHS conformity

Combined use with other medical devices

Disposal

• The device must be disposed of at a suitable collection point for the recycling of electrical and electronic devices in accordance with country-specific regulations. • The device complies with the requirements of the 2002/95/EC RoHS Directive (on the restricted use of certain hazardous substances in electrical and electronic equipment).

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2 Safety Instructions

2.1

Structure of the safety information in these Operating Instructions

Important notes in these Operating Instructions are marked with graphic symbols and signal words. 2.1.1 Warnings of risk of injury Signal words such as DANGER, WARNING or CAUTION describe the degree of risk of injury. The different triangle symbols visually underline the degree of hazard.

1 DANGER

DANGER refers to an immediate hazard, which, if not avoided, will lead to death or severe injury.

1 WARNING

WARNING refers to a potentially dangerous situation which, if not avoided, can lead to death or severe injury.

1 CAUTION

CAUTION refers to a potential hazard, which, if not avoided, can lead to minor or slight injury. 2.1.2

NOTICE

NOTICE refers to a potential hazard, which, if not avoided, leads to damage to property. 2.1.3

NOTE

Warnings of damage to property

Indication of additional information

NOTE provides additional information and useful tips for the safe and efficient use of the device.

2.2

Graphic symbols complementing the safety instructions

Gas explosion: warns of the ignition of explosive mixtures of gases.

Electric shock: warns of electric shock which can lead to severe injury or even death.

Sudden release of spring arm: risk of spring arm suddenly jumping up when dismantling the light head/flat screen.

Ceiling support system crashing: warns of the Ceiling Support System suddenly crashing because additional loads have been attached.

Risk of trapping fingers: warns of trapping fingers in the device.

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Damage to surfaces: warns of damage to surfaces caused by improper cleaning agents and disinfectants.

2.3

Graphic symbols on the device

CE conformity marking: shows conformity with the guidelines of the European Medical Device Directive (MDD 93/42/EEC, 2007). Observe the Operating Instructions: refers to this document.

DEHP marking: Gas hoses can contain small quantities of the DEHP (di-2-ethylhexyl phthalate) plasticizer.

UL marking: device tested by Underwriter Laboratories Inc. for use in the USA and Canada. UL/cULclassification with respect to electric shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005, 3rd ed.) and CAN/CSA C22.2 No. 601.1 - M 90.

2.4

Overview of the most important safety instructions

Site requirements

1 DANGER Gas explosion When in contact with oxygen in the air, medical gases can form an explosive or easily inflammable gas mixture. The ceiling support system is not suitable for use in environments containing inflammable mixtures of anesthetics with high concentrations of oxygen or nitrous oxide. If such high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide occur in the environment of the device, there is a risk of ignition under certain conditions. In accordance with EN 11197, the hazardous area includes an area between 5 cm and 25 cm from the gas leak point.

1 WARNING Electric shock hazard The signal cables (network, audio, video, etc.) must be electrically isolated from the ceiling support system on the device and building connection ends in order to prevent contact with currents which can lead to severe injury or even death.

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2 Safety Instructions

Additional loads

1 WARNING Ceiling Support System crashing The own weights of all the components attached and the weight of the loads attached must not exceed the max. load of the base support unit. • Before attaching additional loads, it must be checked whether the max. load has been observed. • No additional load carriers or loads which are not indicated in the orderspecific dimension sheet may be installed or attached to the base support unit.

Cleaning and disinfection

1 WARNING Risk of contamination and infection for patients through improper cleaning and disinfection The use of unauthorized disinfectants can result in damage to the device paint and coating. Paint particles can fall into open wounds: • Only use disinfectants approved by the manufacturer for use on the following materials: polycarbonate (PC), polyamide (PA), polyvenyl chloride (PVC), acrylonitrile-butadiene-styrene-copolymere (ABS), polystyrene (PS), polyetherimide (PEI), and on silicones. • Disinfectants containing the following substances must not be used: Glycol derivatives: Methyl diglycol, phenoxy ethanol, phenoxy propanol, propylene glycol. Phenols or phenol derivatives: 2-biphenylol, 2-benzyl-4-chlorophenol, 4-chloro-3-methylphenol, chloroxylenol, 3,3-dibromo-5,5-dichloro-2,2-dihydroxy-diphenylmethane [bromine chlorophene], dibromo-4-hydroxy-benzenesulphonic acid, 2methyl-3,4,5,6-tetrabromphenol, 2-oxy-diphenyl, 2,3,4,5,-tetrabromide6-methyl-phenol. Quaternary compounds: Alkyl-didecyl-polyoxethyl-ammonium propionate, alkyl-dimethyl-alkylbenzyl-ammonium chloride, alkyl-dimethyl-ethyl-ammonium chloride, alkyl-dimethyl-ethylbenzyl-ammonium chloride, benzalkonium propionate, benzalkonium chloride [alkyl-dimethyl-benzyl-ammonium chloride, coco-dimethylbenzyl-ammonium chloride, lauryl-dimethyl-benzylammonium chloride, myristyldimethyl-benzyl-ammonium chloride], benzethonium chloride, benzyl-di-hydroxyethyl-coco alkyl-ammonium chloride, coco-dimethyl-benzyl-ammonium chloride, dialkyl-dimethylammonium chloride [didecyl-dimethyl-ammonium chloride], didecyl methoxyethyl-ammonium propionate, mecetronium ethylsulfate, methylbenzethonium chloride, n-octyl-dimethyl-benzyl-ammonium chloride, undecyl amido propyl trimonium methosulfate.

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2 Safety Instructions

Risk of contamination and infection of the patient If cleaning agent/disinfectant is allowed to penetrate the device, excess cleaning agent/disinfectant may drip into open wounds: • Refrain from any other disinfection method than wiping disinfection. • Use cleaning agents/disinfectants sparingly so that no liquid enters the device. • The cloth used to clean / disinfect the device should only be damp, not wet. • Only use disinfectants approved by the manufacturer for use on the following materials: Polycarbonate (PC), polyamide (PA), polyvenyl chloride (PVC), acrylonitrile-butadiene-styrene-copolymere (ABS), polystyrene (PS), polyetherimide (PEI), and on silicones. • Disinfectants containing the following substances must not be used: Glycol derivatives: Methyl diglycol, phenoxy ethanol, phenoxy propanol, propylene glycol. Phenols or phenol derivatives: 2-biphenylol, 2-benzyl-4-chlorophenol, 4-chloro-3-methylphenol, chloroxylenol, 3,3-dibromo-5,5-dichloro-2,2-dihydroxy-diphenylmethane [bromine chlorophene], dibromo-4-hydroxy-benzenesulphonic acid, 2methyl-3,4,5,6-tetrabromphenol, 2-oxy-diphenyl, 2,3,4,5,-tetrabromide6-methyl-phenol. Quaternary compounds: Alkyl-didecyl-polyoxethyl-ammonium propionate, alkyl-dimethyl-alkyl benzyl-ammonium chloride, alkyl-dimethyl-ethyl-ammonium chloride, alkyl-dimethyl-ethylbenzyl-ammonium chloride, benzalkonium propionate, benzalkonium chloride [alkyl-dimethyl-benzyl-ammonium chloride, coco-dimethylbenzyl-ammonium chloride, lauryl-dimethyl-benzylammonium chloride, myristyldimethyl-benzyl-ammonium chloride], benzethonium chloride, benzyl-di-hydroxyethyl-coco alkyl-ammonium chloride, coco dimethyl-benzyl-ammonium chloride, dialkyl-dimethylammonium chloride [didecyl-dimethyl-ammonium chloride], didecyl methoxyethyl-ammonium propionate, mecetronium ethylsulfate, methylbenzethonium chloride, n-octyl-dimethyl-benzyl-ammonium chloride, undecyl amido propyl trimonium methosulfate. • The operator's hygiene regulations must be strictly adhered to. Damage to surfaces Solvents can destroy paint and plastic materials. To prevent damage: • Only use agents without chlorides, halogenides, glycol derivatives, phenols or phenol derivatives and quaternary compounds. • Do not use any petrol, paint thinners or cleaning agents containing alkaline, acidic or aldehyde substances. • Do not apply any scrubbing agents or agents with an abrasive effect.

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2 Safety Instructions

Maintenance

1 CAUTION Performing adjustment work The manufacturer guarantees the safety and functional reliability of the device only on condition that mounting and adjustment work is carried out by an authorized hospital technician or a person with comparable qualification. Warranty The device safety, reliability and performance can only be guaranteed if genuine TRUMPF spare parts or parts approved as suitable by TRUMPF are used exclusively. Inspection intervals The safety and reliability of the Ceiling Support System must be inspected at regular intervals. To this end, the specifications in these Operating Instructions concerning the inspection intervals, scope of inspection, and also care and maintenance, must be observed. Start-up

1 CAUTION Initial commissioning prior to use Prior to use for medical operation, the ceiling support system must be subjected to initial commissioning before being handed over to the operator. • Initial commissioning comprises the functional test and safety inspection of the entire ceiling support system. • Handover must be documented by means of a declaration of acceptance.

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3 Technology of the Ceiling Support System

The Ceiling Support System provides a large number of functions which ensure economic working conditions in an OR or intensive care environment.

Operating radius

The operating radius of the Ceiling Support System is determined by the length of the pendant arms and the swiveling range setting. Thanks to the large adjustment angle of swiveling range of up to 330°, both the pendant arms and the system head have a large range of action.

Friction brakes

Within this range of action, the system head can be freely positioned in the room and attached. By default, the attachment at a fixed position in the room creates a friction brake effect (based on static friction) in the swivel arm joints.

Pneumatic and

The pneumatic or electropneumatic brakes in the swivel arm joints provide for enhanced comfort and increased safety. Controllable pneumatic or electropneumatic brakes provide for improved operational safety thanks to a stable motion lock and thus facilitate the operation of the system head.

electropneumatic brakes

Height adjustment via an electric motor

Stepless mounting of the platforms

Height-adjustable pendant arms are conveniently driven by electric motors. Their attachment at the desired height and the travel motion can be controlled via the keyboard.

The mounting height of the platforms can be adjusted steplessly on the system head. This ensures that the operating comfort can be adapted to the working conditions and the intended use.

Modular concept

The system head is available in three design types - horizontal system head, vertical system head and reduced vertical system head. The horizontal system head can be equipped with support profiles in different lengths to which various accessory components can be mounted.

Integrated supply connections

The system head can be equipped with all the supply connections required for modern surgical techniques.

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4 Identification of the Ceiling Support System

Figure 1

4.1

Identification of the components

A ceiling support system is identified through its rating plate and serial numbers. • The main serial number 1 defines the order-specific overall system, • the individual serial numbers 2 define the assemblies. • The maximum load is indicated on the rating plate 3 . • The main serial number also serves for the identification of components without individual serial numbers and thus enables the delivery of suitable spare parts by TRUMPF customer service. 4.1.1

Serial number of the complete ceiling support system The main serial number of the ceiling support system is indicated on the base of the system flange. 4.1.2 Serial number of the base support unit The serial number of the base support unit is indicated on the inner side of the pendant arm or, in case of height adjustable arms, below the cover. 4.1.3 Serial numbers on the system head The rating plate with the serial number and indication of the load data is attached to the system head column.

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5 Device and Functional Descriptions

Figure 2

5.1

Device description

The ceiling support systems are available in many different configurations as single- or dual-arm systems. All available variants are based on the base types described below. A: Base support unit with two horizontally swivelable arms: 1 canopy for covering the system flange; 2 system flange; 3 upper swivel arm; 4 lower swivel arm; 5 system head with media outlet points; 6 platform with operator handle; 7 operator handle for positioning the system head; 8 buttons for controlling the pneumatic or electropneumatic brakes on the upper and center joint (optional). B: Base support unit with horizontally swivelable arm: 1 canopy for covering the system flange; 2 system flange; 3 swivel arm, horizontally swivelable; 4 system head with media outlet points; 5 platform with operator handle; 6 operator handle for positioning the system head; 7 button for controlling the pneumatic or electropneumatic brake on the upper joint (optional).

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