TRUMPF
Ceiling Mounts Pendants User Manual 7 200 701 Issued Nov 2008
User Manual
40 Pages
Preview
Page 1
Ceiling Mounts User Manual
This is a class II b medical product within the meaning of Annex IX of the EUROPEAN COUNCIL DIRECTIVE 93/42/EEC concerning medical devices (MDD), June 1993. TThe manufacturer declares that this product conforms to the essential requirements of the MPG (German Law on Medical Products), Annex 1, and this is documented by the CE sign.
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Medical Electrical Equipment Classified by Underwriters Laboratories Inc. with respect to electric shock; fire, mechanical and other specified hazards only in accordance with UL 2601-1 and CAN/CSA C22.2 No. 601.1 22TF TRUMPF Medizin Systeme GmbH + Co. KG Benzstraße 26 82178 Puchheim Germany Distribution
Technical Customer Service
Telephone
+49 89 80907-0
Fax
+49 89 80907-20
Telephone
+49 3671 586-0
Fax
+49 3671 586-175
We are constantly working on further developments. Therefore, please understand that we must reserve the right to change the scope of the delivery in respect of the form, equipment and technology at any time. Reprinting, copying or translating this document, in whole or in part, is forbidden without the express written permission of TRUMPF Medizin Systeme GmbH + Co. KG! All rights under the copyright laws are expressly reserved by TRUMPF Medizin Systeme GmbH + Co. KG. Within the bounds of the legal requirements, the manufacturer is only then responsible for the technical safety characteristics of this apparatus if the maintenance, repairs and modifications to this apparatus are performed by him or by someone appointed by him and in accordance with his instructions. © 11/2008
TRUMPF Medizin Systeme GmbH + Co. KG
Contents
Contents 1 1.1 1.2 1.3
Important Information... 3 Proper use of the equipment... 3 Explanation of symbols... 4 Safety instructions... 5 General... 5 Operation... 6 Connections... 6 Maximum load... 7 Protection against infection... 7 Environmental protection... 7
2 2.1 2.1.1 2.1.2 2.2 2.2.1 2.2.2
Preparation for Use... 8 Testing and approval... 8 Gas supply and extraction systems... 9 Mains voltage installation... 9 Equipment testing... 10 Data/weak current systems (options)... 10 Mechanical functions... 10 Horizontal movement... 10 Vertical movement... 11 Installation of the equipment... 13 Mounting on an equipment platform... 13 Installation in the support system head housing... 14 Attach to the sub-mount head... 15 with mounting mechanism... 15 non-equipment-specific platform... 15 with docking unit... 16 Mount on the standard support system arm... 17 with mounting mechanism... 17 non-equipment-specific platform... 17 with docking unit... 18 Installing equipment on mobile infusion poles... 19 Adjustment... 19 Installing equipment on medical rails... 19 Connecting the equipment... 20 Connecting equipment to the patient... 21 Connecting electrical equipment... 21 Europe... 21 International... 21
2.3 2.3.1 2.3.2 2.3.3
2.3.4
2.3.5 2.3.6 2.4 2.5 2.6
User Manual Ceiling Mounts 7 200 701 - 11/2008
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Contents 3 3.1 3.2 3.3 3.3.1
3.5 3.5.1 3.5.2 3.5.3 3.6 3.6.1 3.6.2 3.6.3
Using the Ceiling-Mounted Support System...22 Commissioning...22 Joint brakes...23 Horizontal movement...24 Ergonomically correct operation...24 1 arm support system...25 2 arm support systems...26 Vertical movement...27 Vertical movement - model H...27 Vertical movement - model HB...28 Vertical movement motorized...28 Sub-mount head...30 Attaching the anaesthetic ventilator...30 Setting down the anaesthetic ventilator...31 Moving a sub-mount head without anaesthetic ventilator...31 Support system arm standard...32 Attaching an anaesthetic ventilator...32 Setting down the anaesthetic ventilator...33 Moving a support system arm without an anaesthetic ventilator...33
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Care, Cleaning and Disinfection...34
5 5.1 5.2 5.3
Technical Description...35 Environmental conditions for storage and transport...35 Input rating...35 Classification...35
6 6.1 6.2
Maintenance and Liability...36 Maintenance...36 Liability...36
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Scrap Disposal...36
3.4
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User Manual Ceiling Mounts 7 200 701 - 11/2008
Important Information
1
Important Information Products of the TRUMPF Medizin Systeme GmbH + Co. KG are manufactured to give a long and trouble-free service life. Development, design and production by TRUMPF Medizin Systeme GmbH + Co. KG have been certified in accordance with DIN EN ISO 13485:2003. This guarantees: • highest quality and a long service life, • easy operation, • functional design and • optimisation for the intended purpose. The products fulfil the requirements of the Medizinproduktegesetz MPG (German Law on Medical Products) and bear the CE sign. Please read this user manual carefully from the beginning, in order to familiarise yourself step-by-step with the many and varied functions. The ceiling mounts can be used safely! Reference is made to any residual dangers at the appropriate points in the manual. Please observe the following instructions!
1.1
Proper use of the equipment TRUMPF ceiling mounts are used to hold medical equipment. This equipment is supplied via the ceiling mount with electricity and medical gases • up to a plug connector on the support system head in the case of installed electric cables and gas hoses, and • by short cables and gas hoses from the plug connectors/ tapping points on the support system head to the equipment. This eliminates hazards caused by hanging cables and hoses. Instruments and accessories can be placed on or secured to surfaces provided for this purpose. The support system head can be positioned anywhere within the range of movement of the support system arms in order to enable the user to work under ergonomic conditions.
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Important Information The ceiling mount is designed to bear a defined load. If this load is exceeded, the support system, and particularly the bearings, may be damaged and the support system may take up an angled position. However, there is no risk of fracture. Manually height-adjustable ceiling mounts with a counterweight become more difficult to operate if the agreed set load is under or overshot, and they may become dangerous for both the operator and the equipment.
1.2
Explanation of symbols Important information in this user manual is marked with symbols and keywords. Keywords such as WARNING, DANGER or CAUTION indicate the level of danger involved. The symbols emphasise the message visually. Additional symbols can indicate injury hazards or danger to life and limb. The measures to prevent dangers arising must be implemented without fail! WARNING! Danger to life and limb (for example electric shock)! Risk of serious injuries and damage to property. DANGER! Risk of injury and damage to property. CAUTION! Risk of damage to property. NOTE! Useful additional information and tips. Symbols attached to the inside or outside of the device mean:
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Alternating voltage Potential equalisation Grounded conductor
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Important Information 1.3
Safety instructions Please observe the following instructions: General
• Ceiling mounts must not be commissioned without compliance with all relevant regulations. • When setting down the equipment, make sure there are no objects underneath. People must keep a safe distance away so there is no risk of injury to their feet. Cable and hose lengths may only be adjusted by the equipment manufacturer. • Empty ducts must not be damaged when installing cables. If the strain relief device installed at the factory is removed to assist the installation work, it must be replaced when the work has been completed, as otherwise, the support system may become stiff and this can damage the cables and hoses. • Support systems must not be brought into use until their gas and mains voltage connections have been tested and approved. Warning notices and signs must not be removed until this has been done. • Personnel must be trained before being allowed to work indirectly or directly with a ceiling mount. • In the case of support system heads without an equipment load, the vertical brake must be locked to prevent it from being released accidentally. When the equipment has been removed, the vertical brake may only be released when the missing equipment weight has been compensated for by physical force, as otherwise, the support system arm may shoot up. Then slowly move the support system head into its highest position. (vertical movement - model HB) • Explosion hazard! Before operating equipment, check that the area is free of flammable anaesthetics. This equipment is not designed for use in a hazardous location as defined in NFPA's Flammable Anaesthetics Code. • Setting work and troubleshooting may only be done by specialist personnel. The safety instructions in the Service Manual must be followed. • Adjustable brakes must be set so that they prevent accidental movement of the support system head disconnecting equipment on the support system from the patient. • Repairs and maintenance may only be performed by TRUMPF Medizin Systeme GmbH + Co. KG or by specialist companies authorised by TRUMPF.
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Important Information Operation
• DANGER! Material damage to platform or apparatus! Risk of apparatus falling down! When raising a height-adjustable support system, ensure that apparatus on the platform cannot collide with the height-adjustable arm. • When moving the support system, ensure that there is no risk of injuring people or damaging equipment. • Support systems must not be allowed to hit the stops unbraked so that they are suddenly braked by the stop. • WARNING! Objects or people underneath the support system head are at risk of collision. • To reach the working position, move the support system to the lowest position possible so that the support system head is clearly within the field of vision. To park the support system, move it to the highest position so that the support system head is at a height of at least 2000 mm! This eliminates the risk of people injuring themselves by hitting their heads against the equipment. • It is forbidden hang on to the support system head to pull it down into the working position.
Connections
• The controllable pneumatic vertical brake will not work until the compressed air supply has been connected. If the brake is not in operation, the support system arm may move down when loaded. (vertical movement - model HB) • Only equipment complying with the requirements of EN 60601-1 may be connected to the support system sockets. • Equipment with connecting bolts for potential equalisation must be connected to the potential equalisation connecting bolt on the support system side by a green/yellow cable. • Unless expressly indicated, there are no sockets provided on ceiling mounts for connecting an EEG, EMG or ECG. • When connecting hoses and cables between connectors (sockets for AC, extra low voltage, signals, medical gases, media, etc.) and equipment placed/suspended, clamped on the support system, it must be ensured that the cables/hoses are long enough to prevent the connections being accidentally disconnected, but not so long that they infringe the hygiene specifications. Always take the working radius/range of the support system and equipment into account. Otherwise there is a danger to the life and limb of patients. • The cables and hoses must be easy to clean.
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User Manual Ceiling Mounts 7 200 701 - 11/2008
Important Information Maximum load
• The total weight of the equipment and accessories on the support system must not exceed the maximum permissible load ( ). (see type plate) • The surface area load printed on the platform must not be exceeded!
Protection against infection
• The hygiene instructions must be observed when cleaning the equipment. • Devices and fitments must be cleaned and disinfected before being handed over to service technicians for maintenance and repair work.
Environmental protection
• Dispose of all left over cleaning and disinfection materials and any residues thereof in a safe manner which does not harm the environment. • Ensure that this document is disposed of in a way which does not harm the environment.
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Preparation for Use
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Preparation for Use
2.1
Testing and approval WARNING! Support systems must not be brought into use until their gas and mains voltage connections have been tested and approved. Warning notices and signs must not be removed until this has been done. WARNING! Explosion hazard! Before operating equipment, check that the area is free of flammable anaesthetics. This equipment is not designed for use in a hazardous location as defined in NFPA's Flammable Anaesthetics Code. DANGER! Material damage to platform or apparatus! Risk of apparatus falling down! When moving a height-adjustable support system arm upwards, ensure that the height-adjustable arm cannot collide with apparatus on the platform.
The stops on the bearing point of the support system head and the height limit of the support system arm must be set so that apparatus on the platform cannot collide with the height-adjustable arm. NOTE! If the mounted apparatus is subsequently changed, it must be ensured that there is no danger of collision.
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Preparation for Use 2.1.1
Gas supply and extraction systems The gas supply and extraction systems must be checked and approved for the correct gases, leak-tightness and flow volume. According to DIN EN ISO 9170 and DIN EN ISO 7396, the support system is a gas supply point (gas sockets) and thus a part of the supply system. It must be tested and approved by the company which installed the entire supply system. The • correctness of the gases • leak-tightness • flow volume of the gas equipment installed in the support system have been checked in the factory in accordance with DIN EN ISO 11197. The components of any existing anaesthetic extraction system have been pre-set by the manufacturer. The manufacturer sets the extraction rate to match the supply system.
2.1.2
Mains voltage installation Together with the building installation, the mains voltage installations in the ceiling mount must be initially tested and approved according to local standards. Regular testing in accordance with local standards.
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Preparation for Use 2.2
Equipment testing
2.2.1
Data/weak current systems (options) The function of the data and weak current systems must be checked together with the building installation by a relevant specialist company. Connection work (terminal connections/ soldering) may only be performed by specialist contractors.
2.2.2
Mechanical functions The mechanical functions and settings comply with the client's requirements. Check the functioning of the ceiling-mount. Horizontal movement
Check the end stop settings. There must be no risk of collision between the individual arms or support system heads or with other equipment. The end stops can be adjusted if necessary. (see Service Manual) If the equipment has not been used for some time, the support system arms may be slightly stiff when making the first movements. Swivel the arms from stop to stop several times and they will then move normally again. With controlled joint brake: CAUTION! The joint brake cannot be controlled until it has been connected to the compressed air supply. Once the compressed air is connected, the support system arms must not be able to be moved with normal force. The movement force cannot be adjusted when the brake is released. Without controlled joint brake: The support system arms of the ceiling mount must not move autonomously. Therefore, each arm joint has a brake that can be individually adjusted in the factory or by customer service. Double-arm support systems: The braking effect on the upper support system arm must be greater than on the lower arm in order to achieve a defined movement of the support system head. The movement force can be adjusted. (see Service Manual)
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Preparation for Use Vertical movement
WARNING! Risk of collision with floor or ceiling! Before using a height-adjustable support system arm for the first time, check the upper and lower end stop setting. DANGER! There is a risk of collision if items or people are underneath the support system head! The vertical lift of height-adjustable support systems is set to the highest possible point. The lift can be reduced if necessary. This can be done by adjusting the end position. (see Service Manual) NOTE for standard support system arm. Set the end stop of the support system arm so that the ON switch is actuated by the centering unit of the anaesthetic ventilator after the downward movement has stopped. Manual operation according to load (vertical movement - model H or HB) CAUTION! The load/equipment weight agreed and set must be observed to guarantee safe functioning of the equipment: low operational force and no independent or accidental drift up or down. The weight balancing system must be set so that the support system arm with the equipment and accessories does not move independently, even with the brake released in the case of vertical movement - model HB. (see Service Manual) Vertical movement model H (without vertical movement brake): The balancing system must be set exactly in order to prevent the support system arm from drifting up or down in the working or passage area with a low operational force. DANGER! The support system arm can be raised quickly. Only remove devices from the support system head when the support system arm is in its uppermost position.
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Preparation for Use Vertical movement - model HB (with vertical movement brake): DANGER! The pneumatic vertical movement brake only works when connected to the compressed air supply. The support system arm may drift downwards if it is loaded without the brake being operational. If the support system head is not loaded, the brake must be secured to prevent accidental disengagement! The support system arm can be raised quickly. When the equipment has been removed, the vertical brake may only be released when the missing equipment weight has been replaced by body weight. Then move the support system head slowly to the highest position. The balancing system is set to a predetermined equipment weight when the brake is released. If the equipment weight or load changes, the balancing system has to be re-set. (see Service Manual) Load-independent motor operation (vertical movement model M, support system arm Express or Standard) A counterweight is not necessary. A uniform upwards or downwards movement is achieved by motor mode. NOTE! Intermittent Service maximum 5 cycles! Avoid frequent stop/go operations (more than 5 cycles), as otherwise, the overload protection switches off the motor. The motor is ready to operate again after a brief cooling down period. The movement speed cannot be change.
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Preparation for Use 2.3
Installation of the equipment WARNING! TThe total weight of all the equipment and accessories loaded on the support system must not exceed the maximum permissible load weight ( ). (see type plate) The maximum permissible load weight is calculated from the loading bearing capacity of the support system less the dead weight of the complete support system head (including attachments). The possible load weight is subsequently reduced by the weight of the additional components mounted. The support system may deform (angled position) when the maximum loading weight is reached. However, this does not affect the stability or safety of the support system. The equipment must be installed in accordance with the equipment manufacturer's instructions. The balancing system must be set correctly. (see Service Manual)
2.3.1
Mounting on an equipment platform DANGER! Equipment mounted on the platform must not be allowed to fall off. Possible means of securing the equipment: • by bolting, if there is a suitable tapped hole in the bottom of the equipment. • using TRUMPF Fix-Pos-Set (Item no. 221 9911).
DANGER! The surface area load printed on the platform must not be exceeded.
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Preparation for Use 2.3.2
Installation in the support system head housing The housings are ready for the agreed equipment to be installed. The installation and correct fitting of the panel has been checked at the factory. If the Service later installs equipment or extra low voltage sockets, all components and cables have to be secured again. CAUTION! The requirements of EN 60601-1 must be observed when installing equipment! Empty ducts must not be damaged when cables are installed. If the strain relief devices fitted at the factory are removed to facilitate installation, these must be re-fitted afterwards, as otherwise the support system may become stiff and damage the cables and the hoses. NOTE! Use a soapy solution to insert to pull the cables through the hoses, as this makes it easier. The support system arms of double arm support systems must be extended. 1. Remove the front and rear panels. 2. Place the equipment on the housing bracket. 3. Adjust the height of the housing bracket according to the panel. 4. Fit the panel and position the equipment. 5. Secure the equipment in the final position by bolting or using the TRUMPF Fix-Pos-Set. 6. Connect the equipment to the mains, data/screen, etc. inside the housing (see section 2.4). 7. Fit the panels. DANGER! When fitting the panels, make sure that they fit properly and that all the screws have been tightened, otherwise they may work loose or even fall out. If the equipment is installed by TRUMPF in the factory, the equipment manufacturer does the connection work.
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Preparation for Use 2.3.3
Attach to the sub-mount head There are height-adjustable and non height-adjustable variants of the sub-mount head. They are used for holding suspendable anaesthetic ventilators on equipment-specific attachments and allows the equipment to be adjusted to an ergonomic working height. WARNING! Risk of property damage! The maximum load on the equipment holder is 250 kg, but the support system's maximum permissible load weight must not be exceeded. (see type plate) • The anaesthetic ventilator is held directly by the heightadjustable sub-mount head. • Connect gas and power supply. with mounting mechanism
A example for a equipment-specific mounting mechanism is a fork. • height-adjustable support system head (manual or motor driven): Anaesthetic ventilator fit using trolley. • non-height-adjustable support system head: Anaesthetic ventilator fit using trolley and lifting trolley. • Connect gas and power supply.
non-equipmentspecific platform
• Secure the anaesthetic ventilator directly to the platform according to equipment manufacturer's instructions. • Mount the anaesthetic ventilator on equipment-specific adapter plate and bolt on using the tapped holes provided. • Connect gas and power supply.
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Preparation for Use with docking unit
WARNING! When an anaesthetic ventilator is placed on a docking trolley, it must be secured so that it cannot fall off. The equipment also needs to be positioned so that it cannot collide with the support system head! Please follow the special instructions of the equipment manufacturer. • Latch the ventilator trolley carrying the anaesthetic ventilator onto the sub-mount head. • Connect gas and power supply. • Remove the anaesthetic ventilator from the ceiling-mount by pulling the release knob on the front of the trolley. Sub-mount heads can be attached to non-height-adjustable ceiling mounts later by the service department without the need for any drilling work.
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Preparation for Use 2.3.4
Mount on the standard support system arm NOTE! Set the end stop of the support system arm so that the ON switch is actuated by the centering unit of the anaesthetic ventilator after the downward movement has stopped. The standard support system arm is used for holding suspendable anaesthetic ventilators, and enables an ergonomic working height to be set. It has a motor-driven vertical stroke. WARNING! Hazard to the patient! The maximum load on the equipment holder is 120 kg, but the support system's maximum permissible load weight must not be exceeded. (see type plate) • The anaesthetic ventilator is held directly by the standard support system arm (support system head). • Connect gas and power supply. with mounting mechanism
An example for a equipment-specific mounting mechanism is a fork. • Mount and dismount the anaesthetic ventilator on the device. • Connect gas and power supply.
non-equipmentspecific platform
• Secure the anaesthetic ventilator directly to the platform according to equipment manufacturer's instructions. • Mount the anaesthetic ventilator on equipment-specific adapter plate and bolt on using the tapped holes provided. • Connect gas and power supply.
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Preparation for Use with docking unit
WARNING! When an anaesthetic ventilator is placed on a docking trolley, it must be secured so that it cannot fall off. The equipment also needs to be positioned so that it cannot collide with the support system head. Please follow the special instructions of the equipment manufacturer. • Latch the ventilator trolley carrying the anaesthetic ventilator onto the support system head. • Connect gas and power supply. • Remove the anaesthetic ventilator from the ceiling-mount by pulling the release knob on the front of the trolley.
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User Manual Ceiling Mounts 7 200 701 - 11/2008