issue V8.3E from
01.07.2019
14
The device should be operated only with a functioning mains supply according to VDE 0100-710, or applicable regulations, respectively.
The device is assigned to group 1 (medical equipment-ECG) according to VDE 0100-710.
In order to avoid electrical shock hazard, the device should be connected only to a mains supply with a protective conductor. It should not
be used with a mains supply with protective disconnector.
Installation is to be performed by qualified personnel authorized by the manufacturer.
When assembling the vacuum system, please ensure that you comply with the relevant provisions set out in the accident prevention
regulations and in Paragraph 9 of the EN60601-1 Standard (Protection from mechanical hazards from ME equipment and systems) when
mounting the supports. This applies in particular to the mounting of supports that are not original supports produced by Strässle & Co.
Medizintechnik GmbH as well as to the combination of Strässle & Co. Medizintechnik GmbH products with those of other
manufacturers.
If problems arise during installation or operation of the device, contact your dealer.
The main switch serves an all-conductor disconnector.
The device should be operated only by instructed technical personnel and must be documented.
The instructed personnel should check the system optical and functional for each using.
The device must complete undamaged and functional to be operated in only.
The distributor must be locked in the arm to prevent a self-acting release from the support arm (see 3.3)
By mounting error, improperly performed repair, improper modification and the use of third party products (screws, plugs, connectors,
etc.) it may due to imperfect fit to shear or abrasion, and ultimately solve coming of fortifications, to ensure defibrillation protection.
Improper repairs, improper modifications or non-use of original spare parts and original accessories will affect the protection of the
medical equipment used when unloading a defibrillator.
In the presence of visible damage, stiffness, etc. the supporting arm must be checked by trained personnel
Only original accessories and original replacement parts should be used. The device may only be operated with an original mains cable.
Replacement parts should be disposed in an environmentally beneficial way.
Modification of this device is not allowed without prior consent by the manufacturer (Strässle & Co. Medizintechnik GmbH).
Electrodes may not be brought in contact with oxidising acids or Cyanid solutions.
The specifications of vacuum level under 3.4.3 are to be kept. Too highly selected vacuum levels can lead to blisters on the skin.
To protect the skin, especially sensitive patients, who are repeat measurements with the same absolute placement of the electrodes are to
be avoid, without adequate recovery period 48h or after medical judgment.
Operation in conjunction with HF surgical devices is only permissible if the connected ECG device is suitable for this (see the operating
instructions for the ECG device).
When used in conjunction with an EEG device, the connected EEG device must be able to withstand 110V input voltage in the event of
defibrillation.
If several devices are connected to each other, the summation of leakage currents can lead to a potential hazard.
5.1
Installation site
The device may only be operated in medical rooms.
The device should not be operated in locations where explosions might occur.
The device should be installed in conditions where it is not exposed to excessive smoke, dust, shock, humidity, temperature changes or
direct solar radiation. An adequate distance should be kept from other devices, such as computers, monitors, etc.
The device should be installed at a place where it can´t be climbed or sit upon.
5.2
Cleaning
Before cleaning, press the I/O button to switch off the DT80 vacuum system and disconnect the power cable.
The device should be cleaned with a soft cloth which is moistened only slightly with water. Never use scouring agents, benzene, thinner, or
similar solvents.
Before starting operation, wait until the cleaned surfaces are perfectly dry.
For cleaning of the vacuum electrodes see chapter 4.4.
5.3
Disposal of discarded DT80 suction devices
Discarded suction devices should be returned to the manufacturer. Strässle & Co. Medizintechnik GmbH disposes of them in a professional
way.
For the production of DT80 suction devices, Strässle & Co. Medizintechnik GmbH has provided a number of specifications which require the
use of non-polluting materials and enable separation by pure materials. This greatly reduces the amount of waste.
5.4
General information
In case the device is not used according to the above directions and such use causes injuries or severe effects or damages, the manufacturer
holds no responsibility whatsoever. On demand, further technical documentation is available.
5. Safety instructions
