REF
Product (Brand) Name
Description
Intended Purpose
Variants
Expected Reusable useful life
Environmental/Storage conditions
Not specified
SDM Water This cover provides an IPX2 SDM_WPC protection protection for the SDM against cover the ingress of water.
SDM_WPC is intended to protect the Sentec Digital Monitor from n/a dripping water when the monitor is tilted up to 15° (IPX2).
7 years
Yes
REF
Intended Purpose
Shelf Life
Reusable
Product (Brand) Name
Description
Variants
Environmental/Storage conditions
No.
EC-MI
Ear Clip
Sentec’s Ear Clip, model EC-MI, is intended to attach the Sentec sensors to the earlobe of the patient, recommended for Single use sensor application Ear patients with mature/intact skin. Clip, recommended for patients The use of the Ear Clip is with mature/intact skin contraindicated for patients whose earlobes are too small to ensure adequate sensor application (e.g. neonates).
Reusing the Ear Clip may cause: - Re- and/or cross-infection n/a
2 years
Page 9 . The Sentec Digital Monitoring System (SDMS)
- loss of functionality - improper sensor application and incorrect measurements
Temperature: 10 – 30 °C Humidity: 25%-60%