Carilex DualFlex User manual

Instructions for Use
DualFlex
Hybrid Alternating Pressure Mattress Replacement System
for Dual Stage Nursing
U-2S2602-30631-G V1.2
DualFlex Hybrid Alternating Pressure Mattress Replacement System for Dual Stage Nursing

About this document
Device identification
Validity of the documentation
Subject to change
Translations
Copyright
1
Thank you for purchasing the product: DualFlex.
Please read these Instructions carefully before use and observe the safety
instructions and the requirements for the operation and maintnance of the device.
Idetification details of the device.
These Instructions for use are intended exclusively for devices with the following
specification:
Device name: Hybrid alternating pressure mattress replacement system
Type designation: DualFlex
The serial number is shown on the label on the rear of the power unit.
Details of the device documentation:
This manual describes the hybrid alternating pressure mattress replacement system
DualFlex. It is part of the device documentation. Do not pass this device to a third
party without these Instructions for use.
For the confirmation of the up-to-date status of the documentation, the end page of
the Instructions for use are marked by edition version.
The contents of the Instructions for use can be changed at any time without prior
notice.
For translations into foreign languages, the English version of these Instructions for
use are authentic.
The contents of the Instructions for use are protected by copyright. The resulting
rights, in particular, the reprinting, the photomechanical or digital processing or
copying of the contents or any part thereof, are only permitted with the written
approval of Carilex Medical, Inc.
This provision shall not affect the reproduction for internal use.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

About this document
Information on the manufactures Representative
Carilex Medical GmbH
Hanauer Landstraße 291 B 60314 Frankfurt am Main Germany
[phone]
Manufacturer
For support or complaints
Sales and Service
In the event of a complaint, or if you have any questions about the use of the device
or a need for spare parts, please contact the supplier, that delivered the device to you
or your patients.
Customer service contact for
Information on the customer service
Please contact your local distrubutor.
2
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

Table of Contents
1 Important notes for safe use 5-10
1.1 Designation of the groups of individual s................................................................................... 5
1.2 Notes for the users.................................................................................................................
1.2.1 Instruction....................................................................................................................... 5
1.2.2 Handing over the device................................................................................................. 6
1.2.3 Maintenance and installation ........................................................................................... 6
1.2.4 Information- and Test obligation of the user..................................................................... 6
1.3 Notes for the users ................................................................................................................. 6
1.3.1 Handing over the device................................................................................................... 6
1.3.2 Qualification requirements on the hygiene staff .............................................................. 7
1.3.3 Availability of the instructions for use .............................................................................. 7
1.4 Purpose of the device............................................................................................................. 7
1.4.1 Intended use.................................................................................................................... 7
1.4.2 Attention........................................................................................................................... 8
1.5 Warranty ................................................................................................................................. 8
1.6 Safety information and symbols of the Instructions for use .................................................... 9
1.6.1 Identification of risks of injury.......................................................................................... 9
1.6.2 Identification of material damage..................................................................................... 9
1.6.3 Identification of additional information.............................................................................. 9
1.6.4 Additional symbols to the safety informati
on....................................................................
9
1.7 Symbols on the device....................................................................................................... 9-10
2 Delivery and storage 11
2.1 Packagin g...............................................................................................................................
11
2.2 Delivery control.......................................................................................................................11
2.3 Storage and Transport ..........................................................................................................11
3 Device and functional description 12-16
3.1 Device description..................................................................................................................12
3.2 Functional description.............................................................................................................13
3.3 Operation and function test...............................................................................................
14-15
4 Application of the Hybrid Alternating Pressure Mattress Replacement System 16-18
4.1 Preparing the application.......................................................................................................17
4.1.1 17
Patients beddings..............................................................................................................
4.2 Pressure control during therapy..............................................................................................18
3
5
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

Table of Contents
5 Cleaning and disinfection 19-21
5.1 Cleaning................................................................................................................................. 20
5.2 Disinfection............................................................................................................................ 21
6 Care and maintenance 22
6.1 Inspection.............................................................................................................................. 22
6.2 Maintenance.......................................................................................................................... 22
7 Troubleshooting 23
7.1 Error causes and remedies measures................................................................................... 23
8 Technical data 24
9 EMC declaration
25-26
4
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

1Important notes for safe use
1.1 Designation of the groups of individuals
Named groups of persons The named groups of persons in these Instructions for use are as follows
Operators
Users
•
•
Professionals
The authorised persons are skilled personnel, who are as a rule, the employees
of the operator and who:
•have acquired their knowledge through professional training in the medical-
technical field,
• carry out their activity on the basis of professional work experience and
instructions according to safety-related regulations and are able to detect possible
hazards during work.
In countries in which the pursuit of an activity in the medical-technical area is certified,
the classification as qualified personnel is subject to appropriate approvals.
Patients
Patients in the sense of these instructions are persons in need of care, who use the
air alternating pressure mattress replacement system DualFlex for therapy or care
purposes.
1.2 Notes for the users
Note that the hybrid alternating pressure mattress replacement system DualFlex
should only be used by persons who have been trained in the operation and
the intended use of the device.
1.2.1 Instruction
Training on the device The training of users on how to use the device must be carried out by the qualified
personnel of the operator using the device. If the device is approved for the patient,
then it is obligatory to comply with the instructions of this guidance.
5
An operator (surgical suplier, health insurance, clinic, etc.) is any legal person,
which owns the Hybrid alternating pressure mattress replacement system DualFlex
and uses it, or on whose behalf the device is in use. The operator is responsible
for providing a safe device and to instruct the user properly on the operation and
safe use of the device.
Users are people who are entitled, due to their training or a corresponding instruction
to: operate the hybrid alternating pressure mattress replacement system DualFlex
supervise patients using the device for therapy or care purposes
Users are fully responsible for the safe and correct use of the device. A review of the
functions has to be carried out and the proper condition of the device has to be
checked and confirmed by the user before each use or transfer for use.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

1
1.2.2 Handing over the device
Device approval
1.2.3 Maintenance and installation
1.2.4 Information and Test obligation of the user
Obligations of the user
1.3 Notes for the users
1.3.1 Handing over the device
Procedures for accident prevention
•The device must be thoroughly cleaned and disinfected before the first use.
The initial start-up of the device, as well as the hand over to the user must be
carried out by an authorised personnel assigned by the operator.
After completion, the training it must be documented that the user has understood
the operation and use of the device for special therapy or care purposes.
•
•
6
Important notes for safe use
The device may only be used, if the operator has released it for therapeutic or care
use and if the hand over was carried out properly and under the supervision of
authorised personnel.
After the hand over the users are fully responsible for the safe and dedicated use of
the device.
The maintenance and/or repair of the equipment or parts may only be carried out by
an authorised service agent.
Read these Instructions for use carefully before the first use of the device. This will
allow you to experience all the benefits that the device offers and avoid possible
personal injury and property damage.
A review of the functions has to be carried out and the proper condition of the device
has to be confirmed by the user before each use or transfer for use by patients.
In case of specific issues, which are not covered in enough in detail in these
Instructions for use please contact the supplier or operator for further guidance.
The hybrid alternating pressure mattress replacement system DualFlex is made
according to the current state of the art and is reliable. However, hazards may arise
during the use of this device if it is operated by untrained personnel or it is not operated
as described in these instructions for use.
In order to comply with the regulations of accident prevention and to prevent
accidental damage, the following procedural guidelines are to be followed when
handing over the device:
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

1
1.3.2 Qualification requirements hygiene staff
Hygiene measures The nature of hygiene measures are determined by the use environment of the device.
•If the device is used in clinical areas (e.g. in hospitals, doctors' offices, etc.) the
cleaning and disinfection must be carried out on the product or parts only by
appropriately qualified personnel, who are familiar with the relevant hygiene
regulations.
•When using the device in non-clinical areas the users or trained cleaning
personnel can perform cleaning of the device.
1.3.3 Availability of the instructions for use
Obligation to provide information
1.4 Purpose of the device
To ensure the security of patients and users, the device may only be used for its
intended use.
1.4.1 Intended use
Intended use Anti-decubitus Hybrid Alternating Mattress Replacement System intended to treat and/or
prevent decubitus ulcers otherwise known as bed sores, pressure sores, and
pressure ulcers. Always consult a physician or health professional before using this
device.
Contraindications:
Certain patient conditions (e.g. unstable cervical fracture, fracture of unstable
vertebrae and illness of unstable vertebrae) are contraindicated for use with this
device. Always consult a physician or health professional before using this device.
7
Important notes for safe use
The Instructions for use are an integral part of the device and must be stored in a
place so that the safety instructions and other important information are accessible
at any time and can reviewed by the users.
Do not pass the device to a third party without these Instructions for use. Using the
edition version as a guide always ensure that a current and valid Instructions for use
document is supplied with the device.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

1
Attention Always consult a physician of health professional before using the hybrid alternating
pressure mattress replacement system.
Any and all applications outside of the conditions specified above is regarded as
Unapproved. The user and the operator respectively are exclusively liable for any
damage resulting from the unapproved use.
1.5 Warranty
Warranty terms and conditions
The supplier shall ensure the safety and the correct functioning of the DualFlex only
under the following conditions:
•The device is used for the intended use and maintained only in accordance with
the information provided by these Instructions for use;
•Only original spare parts or accessories approved by the manufacturer are used
•No structural changes are made to the device;
•Inspections and maintenance work are carried out according to the specified
time intervals.
8
Important notes for safe use
1.4.2. Attention
Those parts of the ME EQUIPMENT that shall not be serviced or maintained while
in use with a PATIENT.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

1Important notes for safe use
Safety information and symbols of the Instructions for
use
The safety instructions in this manual are marked with symbols and key words. Signal
words like WARNING, CAUTION or ATTENTION designate the classification of the
risk.
Identification of risks of injury
Identification of material damage
ATTENTION!
Describes a situation that could lead to property damage if it is not avoided.
Identification of additional information
NOTE!
Means application tips and useful information.
Additional symbols to the safety information
Additional symbols to the safety information are those listed below signs.
Machine wash warm: Max. 70 C
Do not bleach.
Do not dry clean
Do not iron
Hang to dry
9
Catalogue number
1.6
1.6.1
1.6.2
1.6.3
1.6.4
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
70oC
CAUTION (ISO 7000-0434A)
Means a hazardous situation which, may lead to minor or severe injury
if it is not avoided.
No modification of this medical equipment is allowed.
WEEE Logo
CE Mark: European Conformity to Medical Device Direcve
93/42/EEC as amended by 2007/47/EC

Important notes for the safe use
Symbols on the device
Type BF Applied Part (IEC 60417-5333)
Date of Manufacture
Manufacturer
Power/Mute
10
Class II Double insulation
1.7
Adjust
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
Functional Earth (FE)
Non-AP/APG
IP21
This medical equipment is Not AP/APG protected
Protected against solid foreign objects in diameter > 12.5mm
Protected against vercally falling water drops

2
2.1 Packaging
The DualFlex is supplied in sturdy cardboard packaging.
All packaging materials are recyclable and can be separated:
Packing: Cardboard
2.2 Delivery control
Check immediately after delivery of the device:
•the completeness of the delivery
•the delivery status of the device
The DualFlex is delivered with the following components
•Power unit 1
•Mattress set with coverlet 2
If the delivery is incomplete or the device and/or the
packaging are damaged, in particular in the case of damage
caused by moisture or water, you should promptly inform the
carrier, as well as the supplier.
2.3
Recommended environmental conditions for Storage and
Transport:
•Ambient temperature: -25 °C to 70°C
•Relative humidity: 0% to 93%
ATTENTION
Storage of the mattress
•Do not fold,
•Do not bend,
•Not more than two layers should
be stacked on top of each other.
•Do not put or store any sharp
instruments or tool with sharp tips.
For long-term storage the power unit should be covered with a
dust protector.
11
Delivery and storage
Storage & Transport
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
1
2

3Device and functional description
3.1 Device description
Power unit
•
•
•
•
Two separate air hoses 10 feed the connected air cells with
compressed air from the power unit. Both pressure hoses
are equipped with a male or female coupling, which cannot
be confused.
•
Coverlet
12
The coverlet is made from a two way strech material.
The power unit 1 is used as the housing for the compressed
air unit as well as the compressed air system and also
features:
a control panel 2 with buttons and lights to adjust the
compressed air system.
two hooks 3 on the back to mount the controller to a bed
a receptacle for an air fillter 4 on the rear Panel
two pipe connections 5 for the pressure hoses
a power cable 6 with a plug to connect the device into a
power socket
Hybrid Mattress Replacement
6
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
The Mattress Replacement constructed in three different
layers, a lower foam base 7 , central air cells 8 and the
top foam layer 9 . The lower foam base provide stability of
the mattress, the central air cells consists of 19 individual
cells which provide alternating pressure to relief pressure
from patient’s tissue. Top foam layer design with optimal
density to provide pressure re-distribution to the patients.
In the top layer foam, a special density design in the heal
section as a heal guard.
7
8
9
10
10

3Device and functional description
3.2 Functional description
Therapeutic effect
When used with alternating pressure the skin of the patient is
periodically off loaded every 10 minutes.
Function of the power unit
The compressed air pump in the power unit feeds the
alternating pressure cells of the mattress with compressed air.
Panel of the power unit
The power supply and the pressure regulation are set by the
buttons on the front panel 2 of the power unit 1 :
•
13
Pressure Monitoring Indicator 6 :
Power unit features an integrated pressure sensor which can
monitor mattress’ internal pressure 24 hours to achieve
optimal internal pressure and to ensure maximum pressure
relief. The yellow LED indicates the device is monitoring the
mattress’ internal pressure while the compressor is inflating.
Low Pressure Indicator 7 :
Both continuous flashing of orange LED and audible indicator
will be triggered to notify medical staff when the mattress has
insufficient internal pressure.
Press the power/mute button 3 to turn on the power unit
and the green LED 4 will light.
The system ‘s default comfort is “auto-set ”.
Press the adjust button 5 to select the desired softness
(comfort) of the mattress to suit your preferences. +1 harder,
+2 hardest. -1 softer, -2 softest.
Caregivers should always perform a hand check by placing
their hands underneath patient’s pelvis area to check if there
is sufficient air support to ensure the patient is not bottoming
out. Adjust the comfort setting to check if it is too soft or too
firm.
5
4
73
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
•
1 2
6

3Device and functional description
3.3 Operation and functional test
To perform a functional test and at the initial start-up of the
power unit take the following actions:
•Fully lay out the mattress. Both air hoses 4 and 5 must be
able to move easily without any kinks or pressure points.
-Insert the compressed air hose 5 into the connecting
piece 2 ,
-Insert the compressed air hose 4 into the connecting
piece 3 .
To disconnect a compressed air hose from the connecting
piece: Press the release 1 .
•
•
Turning on the power unit
WARNING
Electric shock!
Touching live parts can result in a death or serious
injury by an electric shock. Check for damage of
the plug and the main power cable of the power
unit before connecting.
•Damaged components may not be used for
connection!
14
3
5
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
CAUTION:
Avoid Electric Shock, Don’t Open Air Pump!

3Device and functional description
Transport:
If the patient needs to be transported together with the hybrid
alternating pressure mattress system, then the compressed
air supply hoses must be disconnected from the controller and
1. Press the release tabs and disconnect both quick plugs
from the connections on the power unit.
2.
3.
4.
15
connected to close the tubing circuitry 1 .
Check the pressure in the air cells to ensure there is
enough air to support the patient constantly.
Connect the CPC connector 2 and 3 of the two
compressed air hoses together.
Turn off the power unit by pressing the power/mute/unlock
button.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

4
CAUTION
Basic cleaning
Mandatory bed sizes
•
•
•
16
Application of the Hybrid Alternating Pressure Mattress Replacement System
Compliance with the hygiene regulations!
The components of the hybrid alternating pressure mattress replacement system are
not supplied in a sterile condition. Clean and disinfect the components before the
first use.
If the mattress cover is not fixed, the hybrid alternating presure mattress cells may move.
For patients there is a risk that they may be injured if placed in an unstable position.
Always use the DualFlex coverlet. Without the coverlet, there is a high risk of cross
contamination.
The hybrid alternating pressure mattress replacement system DualFlex may only be
used as a support system with a patient lying surface of (W)36 x (L)80 inch.
Do not operate the hybrid alternating pressure mattress replacement system without
safe mounting of the replacement mattress on the bed.
Make sure that the mounting of the replacement mattress dose not impede the
adjustment mechanism of the bed.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

4
4.1 Preparing the application
Fix the mattress 1. Place the bed in the supine (flat) position.
2. Fix the mattress with both straps to the bed frame.
3. Hook the power unit with the two hooks on to the foot board of the bed.
Check that the mounting is stable. Make sure that no additional noise is created
by vibrations of the compressed air unit.
4. Attach both compressed air hoses to the power unit. Make sure that the
compressed air hoses are routed without bending, kinks or pressure points.
4.1.1
Application of the Hybrid Alternating Pressure Mattress Replacement System
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
Patients positioning
Carry out the positioning of the patient in accordance with the patient care, or the
medical instructions on the mattress.
•The patient should be exactly centred on the mattress.
•The head of the patient should rest on the head end of the mattress.
17

4
CAUTION
Loose power cord may cause tripping and serious injury.
Accompanying material caring practices
During the use of the hybrid alternating pressure mattress replacement system
accompanying material caring practices can be carried out, that support the medical
and paramedical measures.
•At light contamination, e.g. leftovers please immediately change the bed linen
and wipe the coverlet with mild soap water and dry thoroughly.
•Use moisture-proof incontinence materials.
•Ventilate the coverlet frequently and always keep it dry.
•Remove the coverlet frequently and ventilate the surfaces and spaces between
the air cells well and keep them dry.
18
Application of the Hybrid Alternating Pressure Mattress Replacement System
4.2
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex

5Cleaning and disinfection
In order to prevent cross-contamination, the cleaning and disinfection of the entire
hybrid alternating pressure mattress replacement system must be carried out between
uses with different patients.
Check electrical components
19
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex
CAUTION
Health hazard!
The contact with contaminated cleaning fluids can cause infections.
Disinfectants can contain harmful substances.
Please follow the Instructions for use of the manufacturer of the disinfectant
and the hygiene of the operator during the cleaning and disinfection.
Wear personal protective equipment:
- Safety glasses;
- Protective gloves;
- Mouth and nose protective
Incompatible cleaning agents!
The parts of the pressure mattress replacement system are made of
plastics. Solvents can undo of the mattress (with air cells) and the coverlet:
- Do not use hydrocarbon solvents, detergents containing alcohol
or acids or alkalis,
- Do not use any abrasive cleaning materials.
Incompatible disinfectants
Cleaning the power unit of the mattress (with air cells) and coverlet:
- Only use disinfectants without chlorides, halides,
- Do not use disinfectants containing gasoline, paint thinner, alkaline, acid,
alcohol or aldehyde (e.g. ethanol, propanol)
In order to avoid the embrittlement of plastic parts:
- Do not use disinfectants containing alcohol.
ATTENTION