Codan IBPM DPT-6000 Gebrauchsanweisung Seite 45

IBPM
DPT-6000 (DPT-6003 & DPT-6009)
DPT-9000 / Xtrans
➡
a new consumable that is required for the intended use of a pressure monitoring set and must be provided.
Since the confi guration of this pressure monitoring set may differ from the device confi gurations on pages 3–9 of these Instructions for Use, the respon-
sible organisation must identify all the consumables for the pressure monitoring set prior to use and provide a suffi cient quantity of these consumables
to the user (see section 5, page 46 – Combination with medical devices from other companies).
4.4.1 Protective caps
Non-vented protective caps are closures with one or more Luer connectors. They are attached to the free Luer ports of a pressure monitoring set and/
or sterile accessory to protect against the ingress/leakage of liquids, air and/or pathogens before and/or during use.
Please note that upon delivery, vented protective caps may be attached to the Luer ports of a pressure monitoring set and/or sterile
accessory. These caps must be replaced with non-vented protective caps prior to use to prevent the ingress/leakage of liquids, air
and/or pathogens.
The list below show all the protective caps that may be found in a CODAN pvb Critical Care pressure monitoring set when it is delivered.
Protective caps from CODAN pvb Critical Care
Illustration
4.4.2 HG-01 for ABSS and ABSS
The individually and sterile packaged blood sampling adapter HG-01 is a class IIa medical device, which enables blood sampling via the sampling port
of the ABSS and ABSS (see section 13, page 54 – Blood sampling).
XL
The sampling port of the ABSS and ABSS
plastic membrane and lead to the ingress/leakage of liquids and/or air.
To puncture the membrane, only use the blood sampling adapter HG-01 (REF: 74.5566) together with disposable syringes and/or
equivalent sampling containers with a Luer connector.
4.4.3 Consumables of the monitoring system
The list below shows all the consumables required for the intended use of the pressure monitoring set within a monitoring system:
• Cannulae and/or catheter(s) (vascular access);
• Bag with isotonic (0.9%) saline solution (for pressure monitoring sets with fi lling and irrigation system for use with a pressure cuff);
• Disposable syringe(s) for pressure monitoring sets with fi lling line for use with a syringe pump).
4.4.4 Other consumables
The list below shows all the other consumables required for the intended use of the pressure monitoring set:
• Disposable syringe(s) and/or equivalent sampling containers for volume shift (see section 13, page 54 – Blood sampling);
• Disinfection wipes/swabs and/or disinfectant (see section 14, page 60 – Disinfection instructions);
• Medical protective gloves.
4.5 Colour coding
Take note of the colour coding of the pressure monitoring lines and one-way or multi-way stopcocks. Red stopcocks and pressure monitoring lines
are intended for arterial, blue for venous, yellow for pulmonary-arterial and green for left atrial applications. Neutral stopcocks and pressure monitoring
lines may be used individually for these applications. Components with neutral colour coding must be suitably labelled prior to use to prevent mix-ups
or incorrect use, for example using coding pins or colour-coded stickers.
Colour coding
Red
Blue
Yellow
Green
20.1028.00/2022-10
(DPT-9003 & DPT-9009)
®
Luer type
Male
Male
Female
Female
Female
Male & female
confi gurations
XL
must not be punctured with needles or cannulas, as this may cause damage to the
XL
Application/catheter position
Arterial
Venous
Pulmonary-arterial
Left atrial
Colour coding
Vented
Red, blue
Red
Neutral
Neutral
Neutral
–
Examples of puncture sites
Radial artery, ulnar artery, brachial artery,
femoral artery, dorsalis pedis artery
Internal jugular vein, external jugular vein,
cephalic vein, basilic vein, subclavian vein
Internal jugular vein
Right femoral vein
Non-vented
Neutral
Neutral
–
–
–
Neutral, blue, red
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