Sentec SDM - Page 3

Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland, www.sentec.com
HB-010103-e Date of release: 01/2022
3
The instructed person from the homecare provider is responsible
- Before starting the installation at home environments, to disable the menu access of the monitor in
order to avoid patients changing monitor settings accidently or on purpose. (see section 1
)
- To affix the enclosed label (EV-010188, depicted below) to the monitor.
-
For setting up the monitor at the patient’s home/site and installation of the Isolation Transformer (see
section 2.3
)
- For selecting appropriate measurement site(s), instructing the patient how to use Sentec Digital
Monitoring System (SDMS) and providing the “Directions for Lay Users”, HB-010069, to the patient.
Other relevant manuals to the SDMS are also available on www.sentec.com/ifu
.
- To instruct the lay operator regarding the following:
•
In the event of unforeseen incidents, error messages or unexplained changes in the
performance of the device, patients shall contact their home care provider’s instructed person.
•
To use the SDM and the Isolation Transformer only in-house and under the specified
environmental conditions.
•
To carefully route and fix cables to reduce the possibility of entanglement or strangulation.
•
To make no changes to the device setup.
-
For switching off and uninstalling the SDMS and disconnecting the Isolation Transformer (see section
2.4).
- For ensuring maintenance (see section 3).
Note: The patient as lay operator cannot modify the SDM’s configuration by using the SDM’s menu.
If the SDMS has been stored below 10 °C / 50 °F, it must be acclimatized for two hours at room
temperature before it can be connected to the mains or switched on. The SDMS may not be
installed and operated in moist rooms (e.g. bathroom).
The Sentec Digital Monitoring System (SDMS) is to be operated by instructed personnel only.
Carefully read this manual, the Technical Manual for the SDM (HB-005752), accessory
Directions for Use, all precautionary information, and specifications before operating the device
(available on www.sentec.com/ifu)
As an additional means of protection, Sentec recommends to connect equipment to a supply
main with protective earth and to ensure that power and protective ground lines are connected
correctly (see socket and wiring testing in the Annex).
During operation, the monitor must be connected to the AC power via the Isolation Transformer.
Use only accessories and spare parts supplied or recommended by Sentec AG. Do not perform
other service and repair activities than specified and described by Sentec AG. Failure to comply
may result in physical injury, inaccurate measurements, and/or damage to the device.