Codan IBPM DPT-6000 Gebrauchsanweisung Seite 46

Instructions for Use – English
5 Combination with medical devices from other companies
Defi ned below are the minimum requirements for medical devices from other companies that must be met to ensure the safe and intended use of a
pressure monitoring set with pressure transducers of the DPT-6000 (DPT-6003 & DPT-6009) or DPT-9000/Xtrans
and/or CODAN pvb Critical Care accessories within a monitoring system. Moreover, it must be proven that the medical devices from other companies
were manufactured and authorised in accordance with all applicable device-specifi c standards and that they enable the pressure monitoring set and/
or accessories to be used in accordance with the operating conditions specifi ed in these Instructions for Use (see section 16, page 61 – Technical
specifi cations and operating conditions).
Any deviation from the listed requirements is always the responsibility of the responsible organisation. The responsible organisation must ensure that
combining a pressure monitoring set and/or accessories from the manufacturer CODAN pvb Critical Care GmbH with one or more medical devices from
another company, including all connections/interfaces, is safe and does not cause any reciprocal interference, which could lead to reduction or loss of
the basic safety and/or essential performance characteristics of one or more devices within the monitoring system.
5.1 General requirements
Medical devices from other companies must be developed, manufactured and placed on the market in compliance with the fundamental safety and
performance requirements of the Medical Devices Regulation (EU) 2017/745 (MDR) or the Medical Devices Directive 93/42/EEC (MDD), and they
must also be CE marked.
5.2 Medical electrical equipment
Any user who combines medical electrical equipment from another company with a pressure monitoring set from CODAN pvb Critical Care, with or
without the aid of accessories, is the System Confi gurator and thereby responsible for ensuring that the monitoring system verifi ably meets the specifi ed
requirements. Medical electrical equipment that is used in an emergency environment and combined with a pressure monitoring set, with or without the
aid of accessories, must also verifi ably meet the current requirements of the European standard EN 60601-1-12.
5.2.1 Control monitors
Control monitors intended to be combined with CODAN pvb Critical Care electrical accessories and pressure monitoring sets within a monitoring sys-
tem for invasive blood pressure monitoring must verifi ably meet the current requirements of the European standards EN 60601-1, EN 60601-1-2, EN
60601-1-6, EN 60601-1-12 (applicable for applications in an emergency environment ) and EN 60601-2-34.
5.2.2 Syringe/infusion pumps
Syringe/infusion pumps intended to be combined with CODAN pvb Critical Care pressure monitoring sets with fi lling line and a disposable syringe within
a monitoring system for invasive blood pressure monitoring must verifi ably meet the current requirements of the European standards EN 60601-1,
EN 60601-1-2, EN 60601-1-6, EN 60601-1-12 (applicable for applications in an emergency environment) and EN 60601-2-24.
5.3 Sterile and non-sterile accessories
Sterile and non-sterile accessories are used for additions, extensions or changes to the confi guration and/or components
of the pressure monitoring set and for signal transmission or attachment (see section 4, page 41 – Device description).
Only CODAN pvb Critical Care accessories are authorised for use with a pressure monitoring set with pressure transducers of
the DPT-6000 or DPT-9000/Xtrans
Critical Care pressure monitoring set. Non-compliance can lead to reduction or loss of the basic safety and/or essential perfor-
mance characteristics.
5.4 Consumables
Consumables are required for the intended use of a pressure monitoring set on a patient within a monitoring system and may have to be used up,
disposed of and replaced before or during use (see section 4.4, page 44 – Consumables).
5.4.1 Consumables with Luer connectors
The Luer connectors of consumables (protective caps, catheters, cannulae, disposable syringes, blood sampling adapters or equivalent blood sam-
pling containers) must be verifi ably manufactured and authorised in accordance with the current requirements of the standards EN ISO 80369-1 and
EN ISO 80369-7 with a 6% (Luer) taper for intravascular or hypodermic applications.
Consumables with Luer connectors that are not manufactured and authorised in accordance with the above-mentioned stan-
dards may allow the ingress/leakage of liquids, air and/or pathogens when fi lling and/or using a pressure monitoring set. Before
using the consumables, verify that they are manufactured and authorised in accordance with the specifi ed standards.
5.4.1.1 Catheters and cannulae
Catheters and cannulae intended to be combined with CODAN pvb Critical Care pressure monitoring sets within a monitoring system for invasive blood
pressure monitoring must verifi ably meet the current requirements of the European standards EN ISO 10555-1 (catheters) or EN ISO 7864 (cannulae).
5.4.1.2 Disposable syringes
Disposable syringes intended to be combined with CODAN pvb Critical Care pressure monitoring sets for volume shifts must verifi ably meet the cur-
rent requirements of the European standard EN ISO 7886-1. Disposable syringes intended to be combined with CODAN pvb Critical Care pressure
monitoring sets with fi lling line for use on a syringe pump for invasive blood pressure monitoring must verifi ably meet the current requirements of the
European standard EN ISO 7886-2.
5.4.2 Other consumables
5.4.2.1 Bags containing isotonic (0.9 %) saline solution
Saline bags intended to be combined with CODAN pvb Critical Care pressure monitoring sets with fi lling and irrigation system within a monitoring sys-
tem for invasive blood pressure monitoring must verifi ably meet the current requirements of the European standard EN ISO 15747.
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series. In addition, the accessories should only be used in combination with the CODAN pvb
®
(DPT-9003 & DPT-9009) series
®
CODAN pvb Critical Care GmbH