Technical Specifications; Replacement Parts And Wearing Parts - Sanitas SIH 21 Instructions For Use Manual

Problem/ Possible Cause/Remedy
Question
Why do I need There are two reasons for this:
to replace the 1. To guarantee a therapeutically
atomiser at effective particle spectrum,
regular inter- the nozzle holes should not
vals? exceed a certain diameter.
Due to the thermal and me-
chanical stresses, the plastic
is subjected to a certain
amount of wear. The nozzle
attachment [10] is particularly
susceptible to this wear. This
can also cause changes to
the droplet composition of the
aerosol, which has a direct ef-
fect on the effectiveness of the
treatment.
2. You are also recommended
to replace the atomiser on
a regular basis for hygiene
reasons.
Does each per- This is absolutely necessary for
son need their hygiene reasons.
own atomiser?

11. Technical specifications

Model
SIH 21
Type
SIH 21/2
Dimensions
(WxHxD) 300 x 180 x 100 mm
Weight 1.65 kg
Operating
pressure approx. 0.8 - 1.45 bar
Atomiser fill max. 8 ml
volume min. 2 ml
Medicine flow approx. 0.4 ml/min
Sound pressure approx. 52 dBA
(acc. to DIN EN 13544-1 section 26)
Mains 230 V~; 50 Hz; 230 VA
connection UK: 240 V~; 50 Hz; 240 VA
Expected service
1000 h
life
Operating Temperature: +10 °C to +40 °C
conditions Relative humidity: 10% to 95%
Atmospheric pressure: 700 to 1060 hPa
Storage and Temperature: 0 °C to +60 °C
transport Relative humidity: 10% to 95%
conditions Atmospheric pressure: 500 to 1060 hPa
Aerosol 1) Flow: 5.3 l/min
Properties 2) Aerosol delivery: 0.171 ml
3) Aerosol delivery rate: 0.082 ml/min
4) Particle size (MMAD): 3.16 µm
The serial number is located on the device or in the
battery compartment.
Subject to technical modifications.
Particle size diagram
Measurements were performed using a sodium fluo-
ride solution with a "Next Generation Impactor" (NGI).
This diagram may not be applicable for suspensions
or highly viscous medicines. More information can be
obtained from the relevant medicine manufacturer.
12. Replacement parts and wearing
parts
Designation
Yearpack (contains Mouth-
piece, Adult mask, Child
mask, Atomiser, Compressed
air hose, Filter)
Note
If the unit is used outside of the specifications, proper
function is no longer guaranteed!
We reserve the right to make technical changes to im-
prove and further develop the product.
This device and its accessories comply with European
standards EN60601-1 and EN60601-1-2 (CISPR 11,
IEC61000-3-2, IEC61000-3-3, IEC61000-4-2,
IEC61000-4-3, IEC61000-4-4, EC61000-4-5,
IEC61000-4-6, IEC61000-4-7, IEC61000-4-8,
IEC61000-4-11), as well as EN13544-1, and is subject
to special safety measures in terms of electromagnetic
tolerance. The unit conforms to the requirements of the
European Directive for Medical Products 93/42/EEC, the
MPG (German Medical units Act).
Notes on electromagnetic compatibility
• The device is suitable for use in all environments
listed in these instructions for use, including domes-
tic environments.
• The use of the device may be limited in the presence
of electromagnetic disturbances. This could result in
19
Material REF
PP/ PVC 601.20