AED CellAED, Руководство пользователя

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6.2 PACKAGING, INSTRUCTIONS,
CONTROLS, INDICATORS AND LABELS
This Section introduces the packaging, instructions,
controls, indicators, and labels of the CellAED®.
LABEL OPERATIONAL INSTRUCTIONS AND
WARNINGS
The outer packaging box (Figure 3B, page 25) and
protective case (Figure 4A, page 26) feature storage
and handling instructions, warnings, and the Date
of Manufacture/ Use-by Date of the CellAED® on
the back. QR codes
(Figure 3B, page 25 and Figure
4A (b), page 26) provide online access to a PDF of
the Operating Instructions, and step-by-step video
instructions for responding to a patient in SCA.
CellAED® PROTECTIVE CASE
For personal, home, public, or office use, the
CellAED® is stored inside a hard protective case
(Figure 1 (c), page 21)
. The back of the case details
additional environmental and operational safety
requirements, and features a tamper evident seal
(Figure 1 (b)). The CellAED® operational label (as
seen through the transparent bag and front of the
transparent protective case) provides clear and
simple operational instructions to follow when a
patient has suspected SCA
(Figure 1 (e), page 21)
.
Do not open this case until the CellAED® needs to
be used to treat SCA.
The CellAED® is sealed in a transparent bag
with ‘Tear here’ tabs
(Figure 2B, page 23) . These
should only be torn open when the CellAED® will
be used.
Each CellAED® has a unique Serial Number (SN)
(Figure 5 (g), page 34).
Each CellAED® also has a
Unique Device Identification number (UDI) (Figure
4A (a), page 26) . The UDI is the combination
of the Global Trade Item Number (GTIN), the
manufacturing date, the expiry date, the batch
number and the unique serial number. These
identification numbers are located beside (01), (11),
(17), (10), and (21), respectively.