2
ABPM
Hardware, description of device for custo screen 300/310/400/pediatric
MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 5
2.2 Intended use
2.2.1 custo screen 300/310/400
custo screen 300/310/400 is an ABPM recorder with an internal power supply which
is used to record and evaluate the blood pressure behaviour of a patient (from age
of 10 years on). The recording time can last for up to 72 hours. The recorder types
300/310/400 are characterised by different functions, see chapter 2.2.3 Functional
features of custo screen recorder types.
The custo screen devices are perfectly safe for use by patients with a pacemaker.
The system is intended for use by trained specialist staff or physicians in clinics
and medical practices. Patients are only allowed to use the recording device after
receiving instruction by trained specialist staff. Patients who are not capable of un-
derstanding and following the instructions given are not allowed to use the device.
This applies in particular to senile patients or patients suffering from dementia.
The device is not suitable for unsupervised use
with unconscious patients.
2.2.2 custo screen pediatric
custo screen pediatric is an ABPM recorder with an internal power supply which is
used to record and evaluate the blood pressure behaviour of children1) (from 3 to 12
years). The recording time can last for up to 72 hours.
custo screen pediatric is intended for use by general practitioners and medical spe-
cialists and also designed for hospitals and clinics. custo screen pediatric is intended
for use on children1). The device is not suitable for new-borns and small children
(patients must be aged at least 3 years).
Before an examination can be carried out, a physician's approval must be obtained
and one of the parents must have received detailed instruction by trained specialist
staff. The device must not be used for recordings on child patients who are not able
to endure the examination.
The device is not suitable for unsupervised use
with unconscious patients.
It is only permitted to carry out an examination if it is ensured that
the child patient is supervised during the entire period of recording
as there is a risk of strangulation.
1) Definition according to
DIN EN 80601-2-30:2016-02:
New-borns < 1 month
Toddlers < 3 years
Children > 3 years
