Lowenstein Medical LUISA, Instructions Manual

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11 Annex
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11.5 Markings and symbols
The following symbols may be applied to the device, the
device ID plate, accessories or packaging.
11.6 Scope of delivery for LMT
31390US-1110 LUISA with
HFT mode
The parts below are included in the standard scope of
delivery:
SYMBOL DESCRIPTION
Pressure measuring tube connection
Valve control tube connection
Patient’s exhaled air outlet on double circuit;
do not block outlet
Inlet; do not block openings
Outlet
Follow instructions for use
Direct current: 12 V, 24 V or 48 V
TYPE:
Type designation of the device
Order number
Suitable for use in aircraft. Meets RTCA/DO-
160G Section 21, Category M.
Unique device identifier
(uniform product code for medical devices)
Serial number
Degree of protection against electric shock:
Protection class II product
Do not dispose of the product in domestic
waste
Follow the instructions for use
IP22
Degree of protection against contact with a
finger. Protection against vertically falling
water drops when enclosure tilted up to 15°.
P
Type BF application part
Manufacturer and, if necessary, date of
manufacture
Indicates the product is a medical device
Permitted temperature range for transport
and storage
Permitted humidity range for transport and
storage
Protect from moisture
Fragile. Do not throw or drop
Federal law restricts this device to sale by or on
the order of a physician
Use multiple times on a single patient
PART ARTICLE NUMBER
Basic device with HFT mode LMT 31470
Exhalation module (disposable) LMT 31425
Leakage circuit, 22 mm Ø LMA 91113
Power supply unit LMT 31569
Power cord WM 27027
Oxygen connecting bushing WM 30669
Set, 12 fine filters WM 29652
Set, 2 coarse dust filters WM 29928
Protective bag LMT 31417
Bag pendant LMT 31408
USB flash drive LMT 31414
Set, LUISA documents LMT 15996US0
Final inspection log LMT 31588
Accessories bag LMT 31440
SYMBOL DESCRIPTION