IncarePort & KlinoPort Pendant Operating Instructions Issued March 2011

Thank you very much for purchasing this Ceiling Support Systems (CSS). 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: • Ceiling Support System klinoPORT® with the following base

support unit types: 705 x 706 x 805 x 806 x 905 x 906 x 1005 x 1006 x

1155 x 1235 x 1245 x 1246 x 1247 x 1255 x 1265 x 1285 x

1295 x 1296 x 1297 x 1298 x 1305 x 1306 x 1405 x 1415 x

1425 x 1445 x 1455 x 1465 x 1475 x

(x represents a device-specific variant designation)

•

Ceiling Support System incarePORT® with the following base support unit types: 1217 x 1227 x 1255 x 1265 x 1277 x

1285 x 1295 x 1296 x 1297 x 1298 x

(x represents a device-specific variant designation)

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How to contact us Please do not hesitate to contact our Customer Service Team • if you have questions about the device and its installation, • to reorder spare parts, • in service or warranty cases. Manufacturer and company placing the device into circulation

TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 D-07318 Saalfeld Germany How to contact us

TRUMPF Medizin Systeme GmbH + Co. KG Benzstraße 26 D-82178 Puchheim Germany Sales

Customer Service Inquiries from 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: 0 36 71 / 586 - 41 175 Customer Service Inquiries from abroad E-mail Visit us on the Internet

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Phone: +49 / 36 71/ 5 86 - 0 Fax: +49 / 36 71 / 586 - 41 175 [email protected] www.trumpf.com www.trumpf-med.com

7200701_03_01 US Operating Instructions - Ceiling Support Systems

Notes on this documentation

Copyright

Information on copyright and industrial property rights • All rights reserved. These Operating Instructions are protected

by copyright law.

Modifications to the device

•

Any use other than that defined by law is subject to written approval 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 a prohibited manner by any person or company.

Modifications and translations • Since our products are subject to continuous further develop-

ment, we reserve the right to modify the form, equipment and technology of our scope of supply. Modifications to these Operating

•

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.

Instructions

Translations

Trademarks • klinoPORT® and incarePORT® are registered trademarks 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 Notes on Safety...8 1.1

How to identify the device ...8

1.2

How to identify the Operating Instructions ...8

1.3 Target groups ...8 1.3.1 Operator...8 1.3.2 User...8 1.3.3 Qualified personnel ...9 1.4 Notes for the operator ...9 1.4.1 Initial start-up ...9 1.4.2 Availability of the Operating Instructions ...9 1.4.3 Warranty ...10 1.4.4 Maintenance and repair ...10 1.4.5 Service life of the device ...10 1.5 Notes for the user ...11 1.5.1 Hands-on training ...11 1.5.2 Duty of the user to keep himself informed and inspect the device...11 1.6 Intended purpose of the device...11 1.6.1 Identification...11 1.6.2 Standards and directives ...12 1.6.3 Use as prescribed ...12 1.6.4 Special conditions of use ...13 1.6.6 Contraindication ...13 1.7 Ambient conditions for operation and storage ...13 1.7.1 Ambient conditions for operation...13 1.7.2 Ambient conditions for storage ...13

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1.8

Combined use with other medical devices ...14

1.9

Disposal...14

Safety Instructions ...15 2.1 Structure of the safety information in these Operating Instructions...15 2.1.1 Warnings of risk of injury ...15 2.1.2 Warnings of damage to property ...15 2.1.3 Indication of additional information ...15 2.2

Graphic symbols complementing the safety instructions ...15

2.3

Graphic symbols on the device...16

2.4

Overview of the most important safety instructions...17

3

Technology of the Ceiling Support Systems ...20

4

Identification of the Ceiling Support Systems...21 4.1 Marking of the components ...21 4.1.1 Serial number of the complete Ceiling Support Systems ...21 4.1.2 Serial number of the base support unit ...21 4.1.3 Serial numbers on the system head ...21

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Table of contents 5

Device and Functional Descriptions ... 22 5.1 Device description ... 22 5.1.1 Base support units ... 22 5.1.2 System heads with accessories ... 24 5.2 Functional description ... 27 5.2.1 Operating range and limit stops ... 27 5.2.2 Functioning and operation of the joint brakes ... 27 5.2.3 Principle of operation of the height adjustment mechanism ... 28 5.2.4 Mains voltage supply ... 28 5.2.5 Loading the system head ... 29

6

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Commissioning... 31 6.1

Initial start-up ... 31

6.2

Commissioning in a medical environment... 31

Operation ... 33 7.1

Operating the friction brakes ... 33

7.2

Operating pneumatic brakes ... 33

7.3

Height adjustment of the swivel arm ... 35

7.4 Executing travel motions ... 37 7.4.1 Positioning the system head ... 37 7.4.2 Positioning the base support unit... 37 7.5 Operating the subsystem head... 39 7.5.1 Picking up a device... 40 7.5.2 Traversing the subsystem head in no-load condition ... 41 7.6

Operating the double pivot system on the standard system head... 42

8

Cleaning and Disinfection... 45

9

Inspection, Maintenance and Repair... 47 9.1

Inspections during operation... 47

9.2

Inspection and maintenance intervals ... 48

9.3

Replacement of parts subject to wear... 50

10 Adjustments... 51 10.1 Positioning attachments... 51 10.2 Adjusting the Subsystem head limit stops... 53 11 Technical Data ... 54 11.1 Device data... 54 11.2 Electromagnetic Compatibility (EMC)... 55

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1 Important Notes on Safety 1.1 •

These Operating Instructions are intended solely for devices with the rating plate bearing the following information: – Device designation: – Type designation: – Device serial number (or higher):

Device identification

1.2 Make sure you have the latest version

How to identify the device

•

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 the country code: – Edition: – Version:

Identification of the Operating Instructions

•

Ceiling Support Systems klinoPORT®/ incarePORT® 100954073

7200701_03_01 US March 16, 2011

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

Target groups

These Operating Instructions refer to the following groups: 1.3.1 Operator • An operator (e.g. a medical practices or hospital) is any individual person or legal entity that owns and operates the device or on whose behalf the device is operated. • The operator shall undertake to provide a safe device and to instruct the user adequately in the operation of the device and its intended use. 1.3.2 User Users are persons who, due to their qualification or training by qualified staff, are entitled to operate and work with the device. • Users are fully responsible for the safe operation of the device and for ensuring that it is used for its intended purpose. •

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1 Important Notes on Safety 1.3.3 Qualified personnel Qualified personnel are authorized persons, 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

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 start-up • These Operating Instructions only apply after proper initial start-up by the operator or the manufacturer's authorized installer. • Ceiling Support Systemss may only be placed into operation if the corresponding gas and supply voltage equipment has been inspected and released for operation in accordance with the instructions on the declaration of acceptance! • If the device has been released for use, the contents of these Operating Instructions are binding for the user. • Danger signs which warn the operator of hazards during installation may only be removed after the device has been released for operation. 1.4.2 Availability of the 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 at any time. • Do not hand over this device to other users without valid Operating Instructions. Based on the ID number and version number, it must be ensured that up-to-date and valid Operating Instructions are supplied with the device.

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1 Important Notes on Safety

Warranty

1.4.3 Warranty The warranty of TRUMPF for the safety and operational reliability of the device is subject to the following conditions: • The device must be used exclusively as prescribed and operated, maintained and repaired as stipulated in these Operating Instructions. • Only spare parts and accessories authorized by TRUMPF are used. • No structural alterations are made on the device. • Inspections and maintenance is carried out at the specified time intervals. • Initial start-up has been carried out and the device has been released for operation by means of a declaration of acceptance. 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, – operator service personnel that 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 warranty of product functionality in accordance with the specifications in the Operating Instructions, the provision of service and also spare parts supply. • TRUMPF applies a quality management system certified in accordance with DIN EN ISO 13485 standard to all of its corporate processes. • This ensures: – top quality, – convenient operation, – functional design, – optimization for the intended use.

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1 Important Notes on Safety 1.5

Notes for the user

Only qualified, authorized and trained personnel may operate this device.

Training

Troubleshooting

1.5.1 Hands-on training • All training must be hands-on at the device and carried out by qualified personnel of the operator or by the installation engineer authorized by the manufacturer. • On completion of the training, it must be documented that the user has understood the special operating measures required for correct use of the device for its intended purpose. 1.5.2 Duty of the user to keep himself informed and inspect the device • Please read these Operating Instructions carefully prior to initial operation of the device. This ensures that you benefit from all the advantages of the device and prevent injury or damage to property. • The user must check that the device is fully functional and in perfect condition before each use. • If you encounter specific problems not covered in sufficient detail by these Operating Instructions, please contact your supplier for your own safety.

1.6 Conformity

Intended purpose of the device

1.6.1 Identification 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 marking: This device is a Class IIb Medical Device according to the European Medical Device Directive (MDD) 93/42/EEC, 2007, Appendix IX.

UL mark

The UL mark confirms that the device has been tested by Underwriter Laboratories Inc. for use in the USA and Canada with regard to risk of electric shock, fire hazard and mechanical hazard.

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1 Important Notes on Safety 1.6.2 Standards and directives The device complies with the safety requirements of the following standards and directives: • MDD 93/42/EC, 2007 - Medical Product Directive; • EN 60601-1: 2006 (IEC 60601-1: 2005) - General requirements for basic safety and ergonomic design; • EN 60601-1-2: 2007 (IEC 60601-1-2:2007) - Medical Electrical Devices - Electromagnetic Compatibility; • EN ISO 11197: 2009 Medical Supply Units; • EMC Directive 2004/108/EC - Electromagnetic Compatibility (of Electrical and Electronic Equipment). UL/cUL classification: • UL 60601-1, 1st Edition, 2006-04-26 • 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

Supporting equipment

Operating range

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1.6.3 Use as prescribed The Ceiling Support Systems (CSS) serves as a mobile supply interface for current consumers and also for the support, positioning and safe keeping of medical devices and accessories. • As a supply interface for current consumers, the system head of the CSS is configured with customer-specific supply for different media: Supply voltage, weak current, medical gases, negative pressure, compressed air. For more detailed information on the correct use of these supply outlet points, refer to the separate Operating Instructions of the manufacturers/suppliers. • Only the supporting equipment (platforms, device holders, etc.) intended for installation on the system head may be used for load bearing purposes. The different load conditions of a base support unit and the individual attachments must be considered: – The load bearing capacity of a base support unit is defined as the maximum equipment load (see rating plate on the system head). If supporting equipment has been attached, the equipment load is reduced by the dead weight of the attachments. – The bearing load of the individual supporting equipment (platforms, device holders, etc.) is restricted by the maximum bearing load indicated on the corresponding component. • The system head can be freely positioned within the operating range defined for the support arms. • Any other use than that under the conditions described above shall be considered as incorrect use. The user or operator shall be exclusively liable for any damage resulting from incorrect use.

7200701_03_01 US Operating Instructions - Ceiling Support Systems

1 Important Notes on Safety

Modes of operation

Incorrect use

Restriction

1.6.4 Special conditions of use • Base support units which exclusively consist of horizontally swiveable arms are suitable for continuous operation. • The horizontally swivelable, motor-driven and height-adjustable system heads with lifting systems operate in intermittent mode. If the thermal motor protection (overheat protection) is activated for safety reasons, the operation of the electric motor is deactivated during the cool down phase. 1.6.5 Incorrect use • The maximum bearing load of the individual supporting equipment and the maximum equipment load of a base support unit must not be exceeded. • Apart from device-specific supporting equipment (subsystem head, platforms, device holders and original attachments), no additional load carriers may be installed on the base support unit and no additional loads may be attached. • The base support unit and the system head must not be exposed to excessive leverage or vibration. • The Ceiling Support Systems (CSS) is not suitable for use in atmospheres with inflammable mixtures of anesthetics with air or 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. 1.6.6 Contraindication No contraindications have been identified.

1.7

Ambient conditions for operation and storage

Different ambient conditions are required for the operation and interim storage of the device. 1.7.1 Ambient conditions for operation • Ambient temperature: 10°C to 40°C; • Relative humidity: 30 % to 75 %; • Atmospheric pressure: 700 hPa to 1060 hPa. 1.7.2 Ambient conditions for storage • Ambient temperature: -15 °C to 60 °C; • Relative humidity: 5 % to 95 %; • Atmospheric pressure: 500 hPa to 1060 hPa.

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1 Important Notes on Safety 1.8 Read the Operating Instructions for combined medical devices

Combined use with other medical devices

The system can be equipped with further medical devices from third-party 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 as specified in IEC 60601-1. Compliance with this standard must be ensured by the operator responsible. •

1.9

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 fulfills the requirements of Directive 2002/95/EC RoHS (restriction of the use of certain hazardous substances in electrical and electronic equipment). •

RoHS conformity

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2 Safety Instructions REF

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 hazard. 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 Warnings of damage to property

NOTICE

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

NOTE

A 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. Ceiling Support Systems dropping: warns of the risk of the Ceiling Support Systems suddenly dropping due to additional loads.

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

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2 Safety Instructions

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). Read the Operating Instructions carefully: Refers to these Operating Instructions. UL marking: This device has been tested by Underwriter Laboratories Inc. for use in the USA and Canada. UL/cUL classification regarding electric shock and fire hazard and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 no. 601.1 – M90.

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2 Safety Instructions 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 mixture of gas. The ceiling supply unit is not suitable for use in atmospheres with high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide.

Additional loads

1 WARNING Ceiling Support Systems dropping

The loading of a base support unit is restricted to the maximum equipment load. Apart from the system head, no additional load carriers may be installed and no additional loads may be attached to the base support unit.

Cleaning and Disinfection

1 WARNING Risk of contamination and infection for patients through improper cleaning and disinfection

Using unauthorized disinfectants can damage the device paint or coating. Paint particles can fall into open wounds: • Use of the disinfectant Terralin is not permitted. • Do not use disinfectants that contain benzalkonium chloride, 2-phenoxylethanol, amino-alkylglycerine. • Only use disinfectants approved by the manufacturer for use with the following materials: Polycarbonate (PC), polyamide (PA), polyvinyl chloride (PVC), acrylonitrile butadiene styrene copolymer (ABS), polystyrole (PS), polyetherimide (PEI) and silicones. • We recommend the cleaning agent Meliseptol (manufacturer B. Braun Melsungen AG, D-

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2 Safety Instructions 34209 Melsungen, phone +49 5661 710) or customary 70% 2-propanol alcohol. Risk of contamination and infection for patients through cleaning/disinfection liquid

If cleaning agent or disinfectant gets into the device, excess cleaning agent/ disinfectant can penetrate open wounds: • Dose the cleaning and disinfectant agents in such a way that no liquid enters the device. • For cleaning and disinfection, it is sufficient to wipe the device with a moist, but not wet cloth. • Refrain from any other disinfection method than wiping disinfection.

NOTICE Damage to surfaces / paint finish

Solvents can dissolve plastic materials. To prevent damage: • Only use disinfectants without chlorides or halogenides. • Do not use any benzine, paint thinners, alkaline, acidic or aldehyde containing cleaning agents. • Do not use any abrasives.

Maintenance

1 CAUTION Carrying out adjustments

The manufacturer only guarantees the safety and trouble-free operation of the device on the condition that all mounting and adjustment work is performed by an authorized hospital technician or person with comparable qualifications. Warranty

TRUMPF guarantees the safety, reliability and performance of the device on condition that only original TRUMPF parts or parts specifically authorized by TRUMPF are used.

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2 Safety Instructions Inspection intervals

The Ceiling Support Systems must be inspected for safety and reliability at regular intervals. To this end, the information provided in these Operating Instructions with regard to inspection intervals, the scope of inspections, care and maintenance must be obeyed.

Commissioning

1 CAUTION Initial start-up prior to operation

Before using the Ceiling Support System (CSS) during medial operation, an initial start-up must be carried out and the CSS must be handed over to the operator following inspection. • The initial start-up comprises functional and safety tests of the entire Ceiling Support System (CSS). • Acceptance shall be documented by means of a declaration of acceptance.

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3 Technology of the Ceiling Support Systems The Ceiling Support Systems provides numerous functions which enable ergonomic operation in the OR or in intensive care.

Operating range

The operating range of the Ceiling Support Systems is determined by the length of the support arms and the swiveling range. The large adjustment angle of the swiveling range of up to 330° ensures that both the swivel arms and the system head have a large operating range.

Friction brakes

Within this operating range, the system head can be freely positioned and fastened. By default, the fastening in the desired position in the room creates a friction brake effect (based on static friction) in the joints of the swivel arms.

Pneumatic brakes

The pneumatic brakes in the joints of the swivel arms provide for enhanced comfort and safety. Controllable pneumatic brakes provide a stable motion stop and thus improve the device's operational reliability and facilitate the operation of the system head.

motor-driven vertical movement

Height-adjustable support arms are conveniently driven by electric motors. Both the height locking mechanism and the travel motion can be conveniently controlled by key operation.

Stepless mounting of the platforms

The mounting height of the platforms can be steplessly adjusted on the system head. The fact that the operating concept can be adapted to the working conditions and purpose of use facilitates operation.

Modular concept

Integrated supply connections

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Many different accessories can be attached to the mounting grooves on all four sides of the system head.

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

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4 Identification of the Ceiling Support Systems Figure 1

4.1

Marking of the components

The components of the Ceiling Support Systems are marked with serial numbers. The serial numbers define the components of a specific Ceiling Support Systems without any risk of confusion: • The main serial number 1 defines the overall system; • the individual serial numbers 2 define the component assemblies. • The load data is indicated on the rating plate 3. Based on the main serial number, the TRUMPF aftersales service can also identify components without an individual serial number in order to ensure that the correct spare parts are delivered. 4.1.1 Serial number of the complete Ceiling Support Systems The main serial number of the overall system of the Ceiling Support Systems at 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 at the upper or lower swivel arm. 4.1.3 Serial numbers on the system head The serial number of the component assembly is indicated on the system head. In addition, the rating plate is attached to the system head: • The serial number is indicated at the system head column. • The rating plate with the load data is located on the right-hand side below the attachment housing.

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