Introduction - Care of Sweden CuroCell IQ Cirrus Instructions For Use Manual

1. Introduction

CuroCell® IQ Cirrus is a fully automated and modern hybrid
mattress system designed to provide excellent comfort while
effectively aiding in the prevention and treatment of
pressure ulcers/pressure injuries. The system identifies the
user and automatically manages all settings to optimize the
pressure according to the user's needs.
Unprevented/untreated pressure ulcers/pressure injuries
can very quickly deteriorate resulting in higher risk of
complications, pain and suffering for the user.
Always read the instructions for use
prior to use.
For further questions regarding installation, use or
maintenance please contact Care of Sweden or your local
distributor.
1.1 General information
This system is a medical device with CE marking in
accordance with Medical Device Regulation MDR (2017/745).
The system has been fully or partially designed and verified in
accordance with the standards listed in section 9.2.
Standards.
According to statutory regulations made by the authorities
regarding medical devices, the manufacturer is required to
report all accidents or incidents involving the products. We
would be very grateful for all information involving accidents
or incidents relating to our products, by reporting them
immediately to us, at Care of Sweden.
1.2 Intended use
The systems consist of a control unit actively controlling and
managing the air flow in the mattress, enabling them to be
used for prevention and as an aid in the treatment of
pressure ulcers/pressure injuries (PU/PI).
1.3 Indications
For users with pressure ulcers/pressure injuries (PU/PI) up to
and including category 4 and unclassified PU/PI (unstageable
and suspected deep tissue injury¹). As well as for users in risk
of PU/PI.
1.4 Contraindications
There are no known contraindications.
1.5 User application
The systems can be used in all kinds of health care
environments.
The mattress is intended for use by persons of a
recommended minimum length of 120 cm. The
recommended user weight is up to 230 kg.
We recommend that position changes are made regularly. The
time interval must be evaluated by the responsible personnel,
depending on the user's status, diagnosis and general
condition.
The mattress should only be used lying
in the lengthwise direction on the mat-
tress with the feet at the end, marked
with the feet symbol.
No training or special skills are required for the use of
CuroCell® IQ Cirrus. It is designed to be easy to handle and
understand, reading the quick guide and the instructions for
use before use is recommended.
Prescription shall be made by persons authorized for
prescriptions and with clinical education. Note that the
user also may be the operator.
NOTE:
1. For certain users, e.g. amputees, the recommended length
measurement may not be reached. Users in these groups may,
however, require other settings, as the entire surface is not
under load. For function controls, refer to section 3.2.
2. When used together with positioning pillows, read the pil-
low instructions for use carefully for correct positioning of
the user.
3. Whenever this product is used with evacuation equipment
(evacuation cover or sheet), it is the responsibility of the
authorised personnel to ensure that evacuation can be
performed safely.
4. The mattress may be inappropriate for use during x-ray
examinations because of the risk of blurred images or
artefacts that may lead to diagnostic errors.
5. In the event of a power cut or similar, the mattress will
retain air for at least 12 hours.
(1) European Pressure Ulcer Advisory Panel, National Pressure Injury
Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and
Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The
International Guideline. Emily Haesler (Ed). EPUAP/NPIAP/PPPIA: 2019
1.6 Other information
Action plan for pressure ulcers/pressure injuries
For the best possible results when using this product, we
recommend a structured and planned approach. Examples
that can be applied to the use of our products can be found
in the 'Action plan for pressure ulcers' guidelines.
The Mattress Guide
This guide provides guidance to personnel and prescribers
when choosing a mattress from Care of Sweden. The
CuroCell® IQ Cirrus is a mattress in function group C.
This information can be obtained from our website, www.
careofsweden.com, or ordered from Customer Services (see
contact information on the final page).
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