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iTD MZ.000 Series Instructions For Use Manual

Stationary carrier system

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INSTRUCTION FOR USE

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Summary of Contents for iTD MZ.000 Series

  • Page 1 INSTRUCTION FOR USE...
  • Page 3 INSTRUCTION FOR USE for stationary carrier systems (including the variable height support arms flexion-port and lf-port) English Page 2...
  • Page 4 The manufacturer declares that this product complies with the basic safety and performanc requirements pursuant to MDR 2017/745, Appendix IX, as documented by the CE mark. This IFU is used by iTD GmbH as well as by TouchPoint Medical Inc. On the product label specific documentation concerning Legal Manufacturer per product is documented.
  • Page 5 VALIDITY These instructions for usage are valid for the following products: Type designation Description Stationary carrier systems and system components modul-port incl. rigid and MZ.000x.xxx / 60xx.xxx swivel arms rm-port and mf-port RS.0xxx.xxx / 43xx.xxx TH.1xxx.xxx TH.2xxx.xxx / 21xx.xxx / 22xx.xxx TS.02xx.xxx / 03xx.xxx / 04xx.xxx TS.60xx.xxx / 61xx.xxx / 62xx.xxx TS.63xx.xxx / 64xx.xxx / 90xx.xxx...
  • Page 6: Table Of Contents

    CONTENT Important information Intended use ............................5 General explanation of symbols ......................5 Safety instructions ..........................8 Assembly Completeness ............................9 Instruction for use / Assembly Instructions ..................9 Horizontal swivel ..........................9 Tilting / rotating equipment ....................... 10 Variable height support arm systems (flexion-port) ................. 10 Wiring ..............................
  • Page 7: Important Information

    IMPORTANT INFORMATION Important information All products from ITD GmbH are manufactured for a long and trouble-free service life. Development, construction, sales and production are certified at ITD GmbH according to DIN EN ISO 13485. This is a basis for: •...
  • Page 8: General Explanation Of Symbols

    IMPORTANT INFORMATION General explanation of the symbols In addition to the symbols listed, other symbols in accordance with Regulation (EU) 2017/745 or ISO 15223 may be used if needed.n for setting them Medical Device Unique Device Identification Equipotential bonding: Identifies equipotential bonding terminals on the housing of the isolating transformer;...
  • Page 9 IMPORTANT INFORMATION General warning sign: This symbol is used at the socket strips. The overall rating given on the name plate must not be exceeded. Only suitable for the interior Distributed by Importer Manufacturer Date of manufacture Use by date Item number Batch code Serial number...
  • Page 10: Safety Instructions

    IMPORTANT INFORMATION Brake: Information about positioning of the support arm in the event of device acceptance and indicates the direction for release and blocking the lockingfunction. Warning of hand injuries Safety instructions General • Only those stationary carrier systems may be operated whose main voltage equipment has been tested and approved by appropriate, qualified personnel! •...
  • Page 11: Assembly

    ASSEMBLY Assembly Completeness Unpack the stationary carrier system and check wether all the parts you have ordered have been included in the consignment. Instruction for use / Assembly Instructions Before you start assembling any equipment, you should read the Instruction for use or Assembly Instructions carefully.
  • Page 12: Tilting / Rotating Equipment

    ASSEMBLY Tilting / rotating equipment If system components are tiltable or rotatable, it is important to ascertain whether the clamping force is appropriate for the unit being fixed in place. If the force applied is incorrectly adjusted, the equipment is at risk of tilting over. Adjustment must therefore be carried out to ensure that the unit can be slightly tilted or rotated, while the unit remains stable in any desired position.
  • Page 13: Wiring

    When swivelling the arms, pay attention to possible cable loops present. Attachment to existing infrastructure When assembling to standard rails (vertical, horizontal), poles, ITD profiles, ceiling lights, supply ducts or manufacturer-specific connections, make sure that there is sufficient stability. As necessary, clarify with the manufacturer of the respective connection.
  • Page 14: Assembly / Operation

    2.11 Additional mounting of system components Additional mounting of ITD system components should only be executed by specialised staff. 2.12 Dismantling and repositioning system components and accessories When system components and accessories are dismantled or repositioned, it is important to remove any units mounted on these elements before any changes are made.
  • Page 15: Electrical Safety

    ELECTRICAL SAFETY Support extrusion The support extrusions (Economy and Profi) are able to accommodate socket strips and offers optimum cable routing for any cables supplying power to units. Under no circumstances should holes be drilled in any support extrusions (Economy, Profi, flat extrusion) because live cables carrying current may be routed in the extrusion.
  • Page 16: Central Power Cutout

    ITD GmbH excludes any liability in this respect! Excluded from the final electrical inspection of system components and accessories ITD GmbH exclude the following system components and accessories from the final electrical inspection: • Multiple socket strips without additional protective conductors that are not wired in the mounting •...
  • Page 17: 3.10 Minimum Safety

    HEIGHT ADJUSTMENT 3.10 Minimum safety ITD GmbH is not aware of any item of equipment or accessory that reduces the minimum safety of the system. Only equipment not presenting a hazard may be used. If necessary, this should be clarified by means of a risk analysis (ISO 14971).
  • Page 18: Miscellaneous

    Repairs to the stationary carrier system and the variable height support arm system flexion-port, lf-port should only be effected by professional personnel. We recommend consulting ITD GmbH on all matters relating to service activities. You will find our service addresses at the beginning of this manual.
  • Page 19: Environmental Conditions

    2002/96/EC is in effect. Spare parts Only spare parts authorized by ITD may be used. A sticker with an order number is attached to the support extrusion of your stationary carrier system. All order numbers and the associated spare parts are archived at ITD GmbH.
  • Page 20: Accessories

    ACCESSORIES / MAINTENANCE Accessories A comprehensive range of accessories is provided in our catalogues or under www.itd-cart.com (information for dealers). Maintenance The stationary carrier system and the varialble height support arm flexion-port, lf-port have been developed and constructed for many years of trouble-free use. Check the functional capability of the following parts every 12 months in order to guarantee safety.
  • Page 21: Technical Data

    Post (“Down-Post”) 10 kg / 22 lbs • Mouse pad 3 kg / 6.6 lbs Load capacity lf-port (variable height support arms) • lf-port (depending on model) 0–8 kg/0–17.6 lb 0–5 kg/0–11 lb 5–10 kg/11–22 lb Responsible for content: ITD GmbH. Instruction for use Index 002...
  • Page 22 ITD GmbH Jahnstrasse 1 CH REP 84347 Pfarrkirchen Germany Johner Medical Schweiz GmbH sales@itd-cart.com Tafelstattstrasse 13a 6415 Arth www.itd-cart.com Schweiz...