WARRANTY / TRAINING / TSC* / SERVICE / CLEANING / DISPOSAL
Chapter 9
WARRANTY / TRAINING / TSC* / SERVICE /
CLEANING / DISPOSAL
Responsibility of the Manufacturer
The manufacturer, assembler, installer or importer is responsible for the effects on safety, reliability and performance of the equipment only if:
• assembly operations, extensions, re-adjustments, modifications or repairs are carried out by authorized personnel,
• the electrical installation of the relevant room complies with the appropriate requirements (e.g. VDE 0100, 0107 and/or the IEC-publications resp. national requirements),
• the equipment is used in accordance with the Instructions for Use and
• the Technical Safety Checks are carried out regularly.
The CE mark confirms that this medical product complies with the
“Council Directive on Medical Devices
93/42/EEC” dated
14th Junde 1993.
B. Braun
Melsungen AG
Warranty
B. Braun provides 24 months warranty, as from the date of delivery, for every
Infusomat® Space (12 months for every Battery-Pack SP). This covers repair or replacement of parts damaged as a result of design/manufacturing errors or material defects. Modifications or repairs to the unit undertaken by the user/operator or by third parties invalidate the warranty.
The warranty does not cover the following:
Elimination of faults attributable to incorrect/unauthorized handling, or to normal wear and tear.
Defective rechargeable battery packs can be returned to B. Braun for further disposal.
Separate collection for electrical and electronic equipment
(currently applicable to EU community only).
Training
B. Braun offers a training for version J. Please ask your local representative for further details.
Technical Safety Check* / Service
The Technical Safety Check is recommended to be carried out every 2 years and should be documented. Servicing work must be carried out exclusively by
B. Braun trained personnel.
59
60
Chapter 9
WARRANTY / TRAINING / TSC* / SERVICE / CLEANING / DISPOSAL
Check regularly
Check for cleanliness, completeness and damage. Use only according to
Instructions for Use. During an exchange interval of the disposable the pump has to perform a self-test. Check the following items each time the pump is switched on: self-check, audible alarm, process- and alarm control indication.
Cleaning
Clean external surface of pump using mild soap suds. Do not use spray disinfectants at the mains power connection. Recommended: disinfectant for wiping available from B. Braun (e.g. Meliseptol® Foam pure, Melsitt 10% and
Melsept SF 10%). After cleaning, allow the device to vent for at least 1 min prior to use. Do not spray into openings in the device. Be sure to observe the instructions provided concerning waste disposal and hygiene for batteries and disposables. The line guide element can be loosened with the help of a pointed object (e.g. ballpoint pen) which is inserted in the lower right hand corner. The cover can then be cleaned under running water. Spray disinfectant on the peristalsis and wipe it with a soft cloth ( Caution : Do not touch peristalsis with sharp object!). When reinserting the line guide element, make sure that it is not damaged and that it audibly locks in. Prime the next infusion line in order to ensure the proper position of each finger. Do not use Hexaquart® or an other alkylamine containing disinfectants.
Disposal
The pumps as well as battery packs can be returned to B. Braun for further disposal. When taking care of disposing of disposables as well as infusion solutions, please consider the applicable hygiene and disposal regulations.
Inspection on Delivery
Despite careful packaging, the risk of damage during transport cannot be entirely prevented. Upon delivery, please check that all items are present. Do not use a damaged device. Contact the service department.
Testing the proper funciton of the device should be performed before initial use.
This is even ruled by law in several countries. A respective form can be obtained from B. Braun.
Included in Delivery
Infusomat® Space, Battery-Pack SP, Instructions for Use-Set.