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1 | User Manual | Users Manual | 981.31 KiB | August 02 2021 / August 03 2021 |
AVA Activity Analytics
Anti-Decubitus Air Alternating Pressure Mattress
Replacement System
Instructions for Use
About This Document
Congratulations and thank you for purchasing this high quality anti-
decubitus system.
Please read these Instructions for Use carefully before use and
observe the safety instructions and the requirements for the operation
and maintenance of the device.
Device
identification
Identification Details of the Device
These Instructions for Use are intended exclusively for devices with
the following specification:
Device name: AVA Activity Analytics System
The serial number is shown on the label on the rear panel of the power
unit and on the tag sewn on the mattress.
Validity of the
documentation
Details of the Device Documentation
This manual describes the AVA Activity Analytics System. 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 is marked by edition version.
Subject to change
The contents of the Instructions for use can be changed by the
manufacturer at any time without prior notice.
Translations
For translations into languages other than English, the English version
of these Instructions for Use is authentic.
Copyright
The contents of these 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.
1
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity AnalyticsAbout This Document
Information on the Manufacturer's Representative
Carilex Medical, Inc.
No. 77, Keji 1st Rd., Guishan District, Taoyuan City(33383),
Taiwan(R.O.C)
EU Representative:
Carilex Medical B.V
Zekeringstraat 41D, 1014BV Amsterdam
Tel:+31 (0) 208905788
Email: nl@carilexmedical.com
Sales and
service
For Support or Complaints
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.
2
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1 Important Notes for Safe Use
5-11
Table of Contents
1.1 Designation of the Groups of Individuals
1.2 Notes for the Users
1.2.1 Instruction
1.2.2 Handing Over the Device
1.2.3 Maintenance and Installation
1.2.4 Information and Test Obligation of the User
1.2.5 Rechargeable Coin Cell Replacement Notice
1.3 Procedures for Accident Prevention
1.3.1 Procedures for Handing Over the Device
1.3.2 Qualification Requirements Hygiene Staff
1.3.3 Availability of the Instructions for Use
1.3.4 Home Healthcare Environment
1.4 Purpose of the Device
1.4.1 Intended Use
1.4.2 Attention
1.4.3 EMC and RF Compliance Statement
1.5 Warranty
1.6 Safety Information and Symbols of These Instructions for Use
1.6.1 Identification of Risks of Injury
1.6.2 Identification of Material Damage
1.6.3 Identification of Additional Information
1.6.4 Additional Symbols to the Safety Information
2 Security Norms
2.1 Correct Use of the System
2.2 Advice
3 Delivery and Storage
3.1 Packaging
3.2 Delivery Control
3.3 Storage and Transport
4 Device and Functional Description
4.1 Device Description
4.2 Operation and Functional Test
3
5
6
6
6
6
6
6
7
7
7
7
7
8
8
8
9
10
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11
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16
17
13-14
16-17
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics6 System Installation, Operation, Transfer and Transport of Patient
22-23
Table of Contents
5 Features
5.1 Control Panel
5.2 Side Panel
5.3 Rear Panel
6.1 System Installation
6.2 Operation
6.3 Transfer and Transport of Patient
7 Application
7.1 Preparing the Application
7.1.1 Inflating the Mattress
7.1.2 Patients Positioning
8 Cleaning and Disinfection
8.1 Cleaning
8.2 Disinfection
9 Care and Maintenance
9.1 Inspection
9.2 Maintenance
10 Troubleshooting
11 Technical Data
12 EMC Declaration
4
18-21
18
21
21
22
22
23
24
24
24
24
26
27
28
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32
25-27
29-31
33-34
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
Named groups
of persons
1.1 Designation of the Groups of Individuals
The named groups of persons in these Instructions for Use are as
follows.
Operators
An operator (surgical supplier, health insurance, clinic, etc.) is any
legal person, who owns AVA Activity Analytics System 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
Users are people who are entitled, due to their training or a
corresponding instruction to:
• Operate the AVA Activity Analytics System
• Supervised 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.
Professionals
The authorized 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 AVA Activity Analytics System for therapy or care purposes.
Lay Operator
A person without the relevant specialized training, the lay operator
should contact with manufacturer or manufacturer's representative
under following conditions :
- for assistance, if needed, in setting up, using or maintaining the ME
Equipment System; or
-to report unexpected operation or events.
5
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
1.2 Notes for the Users
Note that the AVA Activity Analytics System should only be used by
persons who have been trained in the operation and the intended use
of the device.
Training on
the device
1.2.1 Instruction
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 use, then it is obligatory to comply with the instructions of
this guidance.
Device approval
Obligation of
the user
1.2.2 Handing Over the Device
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 authorized personnel.
After the hand over the users are fully responsible for the safe and
dedicated use of the device.
1.2.3 Maintenance and Installation
The maintenance and/or repair of the equipment or parts may only be
carried out by an authorized service agent.
1.2.4 Information and Test Obligation of the User
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 details in
these Instructions for Use please contact the supplier or operator for
further guidance.
1.2.5 Rechargeable Coin Cell Replacement Notice
(1) Hazardous situation might develop by the incorrect polarity
connection or replacement of a coin cell on the desired Control PCBA.
(2) For Coin cell intended to be changed only by Service personnel with
the use of soldering.
(3) The terminals of Coin Cell have clear polarity design and the
location for mounting the Coin cell has been designed to prevent
accidental short circuiting and/or block ventilation.
(4) Seek medical advice immediately if a coin cell has been swallowed.
(5) Store batteries out of reach of children so that they are not
accidentally swallowed.
6
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
1.3 Procedures for Accident Prevention
The AVA Activity Analytics System is made according to the current
state of the art technology 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.
1.3.1 Procedures for Handing Over the Device
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:
• The initial start-up of the device, as well as the hand over to the
user must be carried out by an authorized personnel assigned by
the operator.
• After completion of the training, it must be documented that the user
has understood the operation and use of the device for therapy or
care purposes.
1.3.2 Qualification Requirements Hygiene Staff
The nature of hygiene measures is determined by the use environment
of the device.
• If the device is used in clinical areas (e.g. in hospitals, clinics,
nursing home, elderly homes 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.
Hygiene
measures
Obligation
to provide
information
1.3.3 Availability of the Instructions for 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 ensures that a current
and valid Instructions for Use document is supplied with the device.
1.3.4 Home Healthcare Environment
• This is any place a patient lives (either their own home or a nursing
home) and other places where patients are present (e.g. being
outdoors; in a wheelchair; traveling by any mode and whilst at work)
• Exclusions are: professional healthcare facilities where staff with
medicaltraining are continually on hand when patients are present
(e.g. hospitals;doctors surgeries; dental surgeries)
• Since the Home Healthcare Environment includes a variety of
environments, there is a chance that the medical equipment may
be used in locations with unreliable electrical sources and poor
electrical grounding.
7
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
Intended use
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
The therapeutic air alternating mattress / cushion system is designed
for patients who endure pressure ulcer and potential patients who wish
to reduce the likelihood of pressure ulcer. The device is intended to
treat and prevent pressure ulcers by facilitating blood circulation and
decreasing pressure of each tissue's contact area.
Contraindications:
Certain patient conditions are not suitable for using this type of
device such as fracture of instable vertebrae and illness of instable
vertebrae. Always consult a physician or health professional before
using this device. The use of this system does not replace the regular
repositioning, monitoring, and nursing of the patient.
Attention
1.4.2 Attention
Always consult a physician or health professional before using the
AVA Activity Analytics System. Any and all applications outside of the
conditions specified above are regarded as unapproved. The user
and the operator respectively are exclusively liable for any damage
resulting from the unapproved use.
Additional safety points to be aware of:
• Strangulation by extra-long cables and hoses. To avoid
entanglement, keep children clear of hoses.
• A Warning indicating that replacement by inadequately trained
personnel could result in hazard.
• Do not expose the Home Healthcare System to the sunlight or the
dusty environment.
• Keep the Home Healthcare System out of reach of children.
• Choking caused by small parts being inhaled or swallowed Identify
any loose or detached small parts that may be an issue.
• Potential allergic reactions to materials used in the equipment
Identify any rubber or latex that could be an issue.
• Contact Injuries
Check for any skin irritation due to prolonged contact with the
equipment.
• Expected service life of this medical air pump is 2 years.
• Protection against strangulation or asphyxiation
Means shall be provided to control the risk of strangulation and
asphyxiation of the patient and other to an acceptable level by
routing wires or tubings, and using retention devices.
• No modification of this system is allowed.
8
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
EMC and RF
notices
• For leaning & disinfection Processes of ME equipment being
performed by a Lay Operator shall be investigated by the Usability
Engineering Process.
1.4.3 EMC and RF Compliance Statement
Use of accessories and/or cables other than those specified or
provided by the manufacturer of the SR396 may negatively affect EMC
performance.
• Use of the SR396 adjacent to or stacked with other RF
communications equipment (including antennas) should be
avoided and to be used no closer than 30cm to any part of the
SR396, including cables specified by the manufacturer because it
could result in improper operation.
• Medical Equipment Immunity Performance Criteria Unacceptable
Operating Conditions:
a. Component failures or error of display numerical value.
b. Change or failure in programmable parameters if any.
c. Initiation of any unintended operation or false audible indicator.
d. Cessation, change or interruption of any intended operating
mode.
• All necessary instructions for maintaining Basic Safety and Essential
Performance with regard to Electro Magnetic Disturbances for the
expected service life.
• This medical device that intentionally receive RF energy shall
include:
a. Radiations Frequency: 2.4GHz
b. Frequency Band: 2412-2484 MHz
c. 11Mbps CCK : -91dBm,
64QAM rate 3/4_54Mbps OFDM: -77dBm,
HT20_MCS 7_64QAM rate 5/6: -75dBm,
HT40_MCS 7_64QAM rate 5/6: -72dBm
d. Frequency characteristic: WLAN (802.11 b/g/n)
e. EIRP: 20 dBm
IMPORTANT NOTE: To comply with the FCC RF exposure compliance
requirements, no change to the antenna or the device is permitted.
Any change to the antenna or the device could result in the device
exceeding the RF exposure requirements and void user’s authority to
operate the device.
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
9
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE
STATEMENT
This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or
more of the following measures:
--Reorient or relocate the receiving antenna.
--Increase the separation between the equipment and receiver.
--Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
--Consult the dealer or an experienced radio/TV technician for help.
RF exposure warning
This equipment must be installed and operated in accordance with
provided instructions and the antenna(s) used for this transmitter must
be installed to provide a separation distance of at least 20 cm from all
persons and must not be co-located or operating in conjunction with
any other antenna or transmitter. End-users and installers must be
provide with antenna installation instructions and transmitter operating
conditions for satisfying RF exposure compliance
1.5 Warranty
The supplier shall ensure the safety and the correct functioning of the
AVA Activity Analytics System 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 by certified
personnel according to the specified time intervals.
10
Warranty terms
and conditions
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
1.6
Safety Information and Symbols of These Instructions
for Use
The safety instructions in this Instructions for Use are marked with
symbols and key words. Signal words like WARNING, CAUTION or
ATTENTION designate the classification of the risk.
1.6.1 Identification of Risks of Injury
WARNING
Means a hazardous situation, which may lead to death or severe injury
if it is not avoided.
CAUTION
Means a hazardous situation, which may lead to minor or severe injury
if it is not avoided.
1.6.2 Identification of Material Damage
ATTENTION!
Describes a situation that could lead to property damage if it is not
avoided.
1.6.3 Identification of Additional Information
NOTE!
Means application tips and useful information.
11
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics1
Important Notes for Safe Use
1.6.4 Additional Symbols to the Safety Information
Additional symbols to the safety information are those listed below
Machine Wash Warm : Max. 60°C
Machine Wash Warm : Max. 71°C
Do Not Bleach
Do Not Iron
Do Not Dry Clean
Tumble Dry Medium - Gentle Cycle
Consult Instructions for Use
Declaration of Conformity to Medical Device Directive
2460
Type BF Applied Part
Double Insulated, Class II Equipment
Waste Electrical and Electronic Equipment (WEEE Logo)
Manufacturer
Date of Manufacture
Caution (ISO 7000-0434A)
Catalogue Number
Authorized Representative in the European Community
IP21
Protected against ingress of solid foreign objects ≥12.5mm diameter.
Protected against vertically falling water drops.
NRTL_Safety Certified: SGS_Q Mark logo
12
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics2
Security Norms
2.1 Correct Use of the System
(1) In order to guarantee the correct operation, ensure that the system
is perfectly assembled and securely fasten the mattress with the
specific straps to the bedframe. Make sure that the straps do not
interfere with the bed movements.
(2) Hang the power unit to the bed footboard using the specific hanging
hooks and do not place any objects onto the power unit. Insert the
power cord set into one of the two cable holders placed at each
side of mattress base and fix by the press studs on the cable holder.
Ensure that power cord set is not kinked or tighten up.
(3) Take care to ensure that the sheets are fitted correctly and not
too tight to prevent hammocking. Too many layers of sheets
could reduce the effects of the mattress system. Only breathable
incontinence sleepers may be used.
(4) Do not use the system in presence of live flame or sources of heat.
The power unit extracts the air from the environment and despite its
filter system, smoke can damage the internal components.
(5) After each use the system must be disinfected and sanitized to
prevent cross-infection.
(6) Ascertain that the patient's weight does not exceed the weight
allowed on the bedframe and the maximum therapeutic capacity of
the anti-decubitus system.
(7) Information for the Lay Operator:
The equipment and accompanying Operation Manual should be
simple to understand and straightforward to use for the Lay
Operator, according to IEC60601-1-11 regulation, a lay operator
needs to have at least 8 years of education.
The healthcare professional should brief the Lay Operator on the
use of the equipment and any precautions to be taken, including:
• Precautions to be taken in the event of changes in the
performance of the equipment.
•
• Precautions to be taken regarding the exposure of the
equipment to reasonably foreseeable environmental conditions
(e.g. magnetic and electromagnetic fields, external electrical
influences, electrostatic discharge, variations in pressure etc.)
Information about medicinal substances that the equipment is
designed for, including any that the equipment is NOT designed
for.
Information about medicinal substances or blood products
incorporated into the equipment as an essential part.
• The accuracy of equipment with a measuring function.
• Not using genuine accessories, parts and materials not
•
described in the Operation Manual.
• CAUTION: AVOID ELECTRIC SHOCK, DO NOT OPEN AIR
PUMP!
ATTENTION: ÉVITER LES CHOCS ÉLECTRIQUES,NE PAS
OUVRIR LA POMPE À AIR!
13
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics2
Security Norms
CAUTION:
Ensure no points,
springs protruding
from mattress
which may pierce
the air cells.
2.2 Advice
(1) Use the mattress within the bed side rails and assure that the space
between the sides of the bedframe and the mattress is not big
enough to insert the patient’s head and neck. Neglecting this could
cause serious injuries to the patient.
(2) Avoid electric shock, do not open air pump! In case of problems, get
in touch with the authorized assistance service.
(3) Safety in the presence of inflammable anesthetic gases: the
system is not of category AP or APG protected.
(4) Use of the present system does not exclude repositioning and
changes of posture of the patient wherever possible.
(5) Environmental conditions for operating the Medical Electrical
system:
Temperature: 5°C to 40°C
Humidity: 15% to 90%
Atmospheric pressure: 700 hPa to 1060 hPa
(6) The plug is used for disconnecting the device. Do not position the
power unit in the way which will be difficult to disconnect.
(7) No modification of this system is allowed.
CAUTION
- Ensure no points, springs protruding from mattress which may
pierce the air cells.
- DO NOT expose the AVA Activity Analytics System to the
sunlight or the dusty environment.
- May experience potential allergic reactions to accessible
material used in the AVA Activity Analytics System.
- Keep the AVA Activity Analytics System out of reach of children.
- Skin irritation due to prolonged exposure to mattress or other
accessories.
14
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics3
Delivery and Storage
3.1 Packaging
AVA Activity Analytics System is supplied in sturdy cardboard
packaging. All packaging materials are recyclable and can be
separated.
Following actions could be unsafe as applicable: Use of accessories,
detachable parts, and materials not described in the instructions for
use.
AVA Activity Analytics System is delivered with the following
components:
3.2 Delivery Control
Check immediately after delivery of the device:
• the completeness of the delivery
• the delivery status of the device
• Power unit
Including: Power unit x 1
Power cord set x 1
Instruction for Use x 2
• Mattress replacement
Including: Mattress x 1
Coverlet x 1
Sensors’ pad of the Mattress x 1
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.
3.3 Storage and Transport
Recommended environmental conditions for storage and transport:
• Ambient temperature: -25°C to 70°C
• Relative humidity: 0% to 90%
ATTENTION
Storage of the mattress
- Always roll the mattress, do not fold or bend.
- Do not put or store with any sharp instruments or tool with
sharp tips.
For long-term storage the power unit should be covered with a dust
protector.
15
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics4
Device and Functional Description
4.1 Device Description
Power unit
The power unit is used as the housing for the air source as well as
control features:
• A control panel with buttons and lights to adjust the air system.
• Two hooks on the back to hang the power unit to a bedframe.
• A receptacle for an air filter on the rear panel.
• Two air outlets for quick coupling.
• A rapid connector for transfer cable to provide power to sensors’ pad
• A power cord set with a plug to connect the device into a wall
and collect sensors’ data.
socket.
Mattress replacement
The mattress replacement consists of multiple set of air cells which
work in dynamic or static mode to relief and redistribute pressure.
CPR
The CPR function is activated by a special valve with circular
mechanism located on the right side of the mattress near the torso area.
With a rapid maneuver opening the CPR valve, the mattress deflates in
the torso area, allowing the Cardiac Pulmonary Resuscitation procedure
to be activated within 15 seconds. The CPR valve, well-marked and
built-in the side of the mattress prevents accidental opening, and it can
be opened with a short clockwise rotation, with a single movement and
with the use of one hand only.
16
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics4
Device and Functional Description
4.2 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 replacement mattress. Both air hoses must be able
to move easily without any kinks or pressure points.
• Make sure that the CPR valve is closed.
• Push in the quick coupling of the mattress firmly into the air outlet of
• Push in the transfer cable of the mattress firmly into the rapid
the power unit.
connector of the power unit.
• To disconnect mattress from power unit, simply just press both of
the grey button on the quick coupling and pull, then press the black
button on the transfer cable and pull.
• For function test details, please refer to Chapter 5 Features, please
make sure all functions work normally before use.
Grey buttons on both
sides to disconnect
the mattress
Rapid connector for
transfer cable of the
mattress.
Quick coupling of the mattress
Turning on the power unit
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!
17
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics5
Features
5.1 Control Panel
Power
Press power button to power on or off the power unit. Please make
sure that the power cord is securely inserted into the proper wall socket
and the black cable of the mattress is inserted into the power unit. The
system will automatically start the initial inflating and calculating the
mattress, ring light of knob will be spinning in green. After the calculation
is completed, whole ring light of knob will bright in green to indicate that
the system is ready for patient placement.
To reset the power unit to default setting (clean the Wi-Fi connection
setting and start up in dynamic mode with 10 minutes cycle time), press
and hold the Power button for 10 seconds when the power is on.
Ring Light of Knob
AVA Activity Analytics System features with a ring light of knob to indicate
three kinds of conditions.
● In initial stage, when compressor is inflating, ring light will spin in
● When whole ring light of knob bright in green, it means that patient
green until inflating done.
can lay on the system,
● When system detecting patient already lay on the mattress, ring light
of knob is spinning again until it shows corresponding envelopment
rate, then ring light is shown in static green.
● When patient lay on the mattress, user can change the mattress to
the preferred hardness via adjusting the envelopment rate.Turn the
knob clockwise to increase the envelopment rate, then the mattress is
softer, or turn the knob counter clockwise to decrease the envelopment
rate, then the mattress is harder. The range of envelopment rate is
from 20% to 80%.
IMPORTANT :
Envelopment rate can only be adjustable in Static and Dynamic mode.
● AVA Activity Analytics provide a reposition reminder. When it detects
patient keep the same position exceed 120 minutes,the ring light of
knob will blink in pink.
Dynamic Mode
Dynamic Mode is a therapy mode in which air cells continuously
alternate in an A-B-A-B (odd and even number of air cell sets) pattern to
relief pressure and increase blood flow of the patient tissue. The 3 cells
at the head are always excluded from the alternate.
18
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics5
Features
Multiple Cycle Time
This button is used to select cycle time in dynamic mode. The number
indicators correspond to the time for 1 complete cycle.Three cycle times
can be selected: 10, 15 and 20 minutes.
Static Mode
Static Mode or Continuous Low Pressure mode is the therapy in which
all air cells maintain a constant low pressure support. This therapy
mode allows the maximized envelopment of the patient; molding the
air around the patient contact surface, therefore creating the optimal
pressure redistribution.
Max. Inflation
By pressing the Max. Inflation button, the system will rapidly bring the
mattress to maximum steady pressure, which allows caregiver to perform
the daily nursing procedures. A white LED with count down of remaining
Max. inflation time onleft 7-segement display indicates the activation of
this function. In Max. Inflation mode,only Max. Inflation, Power,Transport
and Unlock button could be activated. Press this button again to stop
this function with one beeping or the system will automatically return to
previous setting after 20 minutes with two beeping.
Pulsate Mode
The Pulsate mode, also called DBE (Deep Breathing Exercise) is a
function in which the system will cycle between Max. Inflation and
proper setting.A white LED indicates the activation of this function.
The system will deflate the mattress within 120 seconds to the proper
height and maintain the proper height for approximately 60 seconds,
then inflate the air to increase the pressure to the proper height in 90
seconds and maintain for approximately 60 seconds. Press to select the
pulsate mode cycle time: 20, 40 and 60 minutes. The default cycle time
is 60 minutes. After a cycle is complete, the system will switch back to
the previous setting automatically.
Please note that there is no DBE function when mattress is upright.
1. When bed is upright, user is not able to active Pulsate function.
2. If user upright the bed In pulsate mode, this function will be
deactivate and back to previous mode.
Transport Mode
The transport mode is used to maintain the pressure of mattress for
when transporting a patient. Once the Transport button is pressed,
the white LED will flash to indicate this mode is activating.When the
transport mode is ready, the white LED will stay lit, which signals
the user to unplug the power cord. Press this button again to cancel
transport mode manually or reconnect the power cord after finish
transporting the patient, and the power unit will return to previous mode
automatically. If the transport mode is selected, but the power cord is
not unplugged, nor the mode is manually canceled, the system will
return to the previous setting automatically after 30 minutes.
19
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics5
Features
Mute
User may press this button to turn off the audible indicator. After mute,
the audible indicator will not re-start again and only have LED flashing to
visually notify the caregivers until the problem is solved.
Panel Unlock
When there is no operation after 2 minutes, system will automatically
lock the control panel. The white LED will light to indicate the panel is
locked. All buttons will be locked except the Max. Inflation and Mute
button which allow user to mute audible alert. Simply press and hold this
button for 3 seconds to release it from locking.
Failure Indicator LED
This yellow LED is to indicate that the mattress has abnormal pressure
including insufficient pressure, excessive pressure and service required
including bottoming out,power issue,rator valve issue or sensor
communication issue. There will be both audible beeping and visual LED
indicators. Audible indicator will turn off after pressing the Mute button
and it will not start beeping again to avoid acoustic pollution, but the LED
will stay flashing until the problem has been solved.
WiFi Indicator
There are three kinds of LED colors and four kinds of conditions of Wi-
Fi indicator. Please refer another IFU to learn how to set the Wi- Fi
Connection.
(1) Amber. There is no Wi-Fi connection setting via mobile APP.
(2) Blinking blue. Power unit is trying to connect to Wi-Fi router
(3) Blinking white. Power unit is trying to connect to server.
(4) Static white. Power unit is connected.
(5) LED is off: Turn off the Wi-Fi function and become standalone version.
• IMPORTANT
• IMPORTANT
If no action has been done in 30 minutes, the device will turn into
standalone version.
Reset power unit for Wi-Fi settings via press power button for 10
seconds.
Digital Number display - Envelopment rate
Show Envelopment Rate in the middle digital number display of the
panel. The number will be changed via revolving the knob.
• IMPORTANT :
Strongly suggest that the envelopment rate must higher than 50 to
keep the best theraphy and the accurate sensor detection.
Digital Number display - Cycle Time
Show Cycle time or countdown time in the left side digital number display
of the panel.
20
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics5
Features
5.2 Side Panel
1
3
Air Outlet (1)
Quick coupling enables a rapid and firm connection between the
mattress and the power unit.
Power Receptacle (2)
Two pin IEC 60320 C18 AC inlet to accept power cord set with 2 Pin_
IEC 60320_Type C17 IEC connector.
Power Unit Outlet (3)
Provide the power to sensors of mattress and collect the sensors’ data
from the mattress to power unit.
Wi-Fi Mac ID (4)
The QR code of Wi-Fi Mac on the out case is for user setting the Wi-Fi
connection easily via “Initial tool"mobile APP.
5.3 Rear Panel
2
4
2
3
1
4
Hanger Hooks (1)
The hooks are designed to fit with multiple footboard widths. They are spring-
loaded and fold away on the back panel when not in use.
Convenient Handle (2)
It provides additional gripping surface for user to carry the power unit.
21
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics6
System Installation,Operation,Transfer and Transport of Patient
Specification ID Label (3)
This label includes all the information for medical device and safety
requirements.
Air Filter (4)
We recommend inspecting and cleaning this filter monthly or more often,
depending on the environment the unit is being used. Failure to keep the
filter clean will result in shorter life span of the unit and/or unit failure. When
replacing, be sure to use Carilex standard filter to optimize the performance of
the power unit.
6.1 System Installation
(1) Remove the existing mattress.
(2) Put the mattress on the structure of the bedframe with the logo at
the foot of the mattress. Fasten the mattress with the use of the
straps ensuring that the functions and movements of the bedframe
are not limited before proceeding to the next step.
(3) Hang the power unit at the foot of the bedframe with aid of the
hanger hooks.
the power unit.
(4) Push the quick coupling of the mattress firmly into the air outlet of
(5) Push in the transfer cable of the mattress firmly into the rapid
connector of the power unit.
(6) Insert the power cord set into a wall outlet. Ensure that the cable is
not in the way of the operators and the movement of the bedframe.
(7) Check the air cell holder of mattress is flat without any fold before
initiating and inflating the mattress.
(8) Check 26pcs rubbers of sensors’ pad are protruding.
(9) The power button is bright in static white.
(10) Push the power button to initiate the system.
• IMPORTANT
The initial process will take longer than35 minutes.It takes 35 to 45
minutes depends on mattress size.
6.2 Operation
(1) Initiate the system by pressing the power button and wait for the
pump beginning to inflate the mattress air cell. AVA Activity Analytics
is equipped with Carilex’s IDS technology,and the system will
automatically provide the optimal envelopment rate to patient. Once
the patient is on the mattress,the system will automatically adjust
and customize the pressure setting that is most suitable for the
individual patient load and position.
(2) Ensure to select the appropriate therapy mode and cycle time,
according to the physician’s decision.
(3) IMPORTANT:
Tucking in the coverlet too tensely significantly reduces the
mattress' effectiveness.
22
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics6
System Installation,Operation,Transfer and Transport of Patient
(4) WARNING!
Use the mattress within the boundaries of the bedframe and
assure that the space between the sides of the bedframe and the
mattress is not big enough to insert the patient’s head and neck.
Neglecting this could cause serious lesions to the patient.
(5) Always turn off the power unit by using the power button. Failure to
do so may cause machine malfunction.
Transfer and Transport of Patient
6.3
Transfer
We recommend carrying out the transfer of the patient by using Max.
Inflation to inflate the mattress to maximum pressure and ensure that
the bed is well-positioned and steady.
Transport
There are two ways to transport patient with the system. One is
using Max. Inflation setting to inflate the entire mattress to maximum
pressure. After the mattress inflates to maximum pressure, power off
the power unit and detach the quick coupling and transfer cable of
the mattress from the air outlets and rapid connectors of the power
unit. Then connect the two quick couplings together to retain air in the
mattress and the mattress will stay inflated over 15 hours.
Please note that the server will show “Offline” of this bed in transport
mode, and the Wi-Fi connection will be resume when the power unit
turned on.
Another way is using transport mode to keep the entire mattress
pressure and the mattress will stay inflated over 12 hours. For longer
transport time, press Max. Inflation before activate transport.
Once the transportation phase is complete, reconnect the mattress to
the power unit and switch the power unit back on. If transport mode is
in operation, simply reconnect the power cord set and the power unit
will back to previous setting automatically. It is not necessary to move
the patient during the re-inflating maneuver.
Mandatory
bedframe size
It is mandatory to select proper bedframe size for the AVA Activity
Analytics System.
Do not operate the AVA Activity Analytics System without safe installing
of the mattress onto the bedframe. Make sure that the fixing of the
mattress does not impede the adjustment mechanism of the bedframe.
23
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics7
Application
Fix the mattress
7.1 Preparing the Application
(1) Place the bedframe in the supine (flat) position.
(2) Fix the mattress with the straps onto the bedframe.
(3) Make sure that the CPR valve is closed.
(4) Hang the power unit with the two hooks on to the footboard of the
bedframe and check that the fixing is stable.
(5) Connect the quick coupling of the mattress to the air outlet of the
power unit. Make sure that the air hoses are routed without bending,
kinks or pressure points.
(6) Set the Wi-Fi connection between power unit and intranet server
via mobile APP. Please refer"Server Management System
IFU(Distributor usage)" for details.
7.1.1 Inflating the Mattress
In preparation for the patient the air cells may be inflated in advance
by the power unit. The head cells should be fully inflated before patient
placement to ensure that the head position is stable.
IMPORTANT
• Do not place patient on the mattress before initial calibration
ready which knob ring LED show static green. It may cause initial
calibration fail and sensor detection abnormal.
• Use the mattress within the appropriate bedframe and assure
that the mattress is flat on the bedframe and the air cell is no any
extrusion or bending.
7.1.2 Patients Positioning
Carry out the positioning of the patient in accordance with the local
patient care guidance.
• The patient should be centered on the mattress, with equal distance
from the left and right mattress' sides.
• The head of the patient should rest fully on the head air cells.
Pressure points on protective body areas!
CAUTION
During the application of the AVA Activity Analytics System, the
skin of the patient must be regularly checked by medical and
nursing staff and caregivers.
CAUTION
• Loose power cord set may cause tripping and serious injury.
• When the patient is on the mattress,do not turn off the power unit
manually to avoid the bottoming out and influence the curative
effect.
24
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics8
Cleaning and Disinfection
In order to prevent cross-contamination, the cleaning and disinfection
of the entire the AVA Activity Analytics System must be carried out
between uses with different patients.
Check electrical
components
Electric shock!
Water has a high electrical conductivity. Contact with liquid under
voltage can lead to a fatal electric shock. For the cleaning and
disinfection operations:
WARNING
• Turn off the power unit.
• Unplug the power cord set from the power socket.
CAUTION
Health hazard!
The contact with contaminated cleaning fluids can cause infections.
Disinfectants can contain harmful substances.
Please follow these 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.
ATTENTION
Incompatible cleaning agents!
The components of the AVA Activity Analytics System are made of
thermoplastic polymers. Solvents can spoil synthetic material and
coating. Strong acids or alkalis can cause embrittlement.
Cleaning the power unit, 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.
• Do not splash liquid on sensor’s pad of mattress.
Incompatible disinfectants
Cleaning the power unit, the mattress (with air cells) and the 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 thermoplastic materials:
• Do not use disinfectants containing alcohol.
25
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics8
Cleaning and Disinfection
Cleaning of the
power unit
Cleaning of the Surfaces of the Power Unit
(1) Turn off the power unit and unplug the power cord set from the
Cleaning of the
coverlet
8.1 Cleaning
When using the AVA Activity Analytics System in non-clinical areas the
users or appropriately trained cleaning personnel can carry out the
cleaning of the device.
WARNING
Remove the power cord set from the wall socket before
cleaning of the power unit. Do not spray any cleaning liquid
directly onto the power unit.
(2) Wet a soft cloth with water, mix it with commercially available
socket.
washing-up liquid.
(3) Wipe off dirt and dust accumulations.
(4) Then dry the surfaces with a clean soft cloth.
Cleaning the Coverlet
The coverlet can be easily removed by derailing the zipper between
coverlet and the mattress base. The cleaning of the coverlet can
be done by using any of the available disinfectants at their usual
concentration. At the end, rinse disinfectant off thoroughly with
water and leave to dry. Avoid detergents containing phenols or other
corrosive substances. Ensure that the mattress and the coverlet are
dry before new use. The hygiene regulations of institution are to be
followed in the institutional care environments.
(1) Wet a soft cloth moderately with water, mix it with commercially
available washing-up liquid. Wipe off dirt.
(2) Wipe cleaned areas with soft dry cloth.
(3) If heavily soiled the coverlet can be washed in the washing machine
using commercially available detergent.
(4) Washing temperature please follow the instruction on the washing
care label.
(5) Dry the coverlet thoroughly after washing. Make sure that no
moisture remains in folds or creases.
(6) Do not put the coverlet in the dryer or near sources of heat.
26
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics8
Cleaning and Disinfection
If the coverlet is soiled or loses its water-resistant properties, it must be
replaced.
Any resulting damage of the mattress caused by a spoiled coverlet will
be not covered by the warranty.
Please follow the hygiene control regulations of your local authority.
WARNING
If the mattress coverlet is not securely fixed onto the
mattress, the air cells and coverlet movement may be
unstable and may cause ricks of patient injury.
ATTENTION
Unpermitted after-treatment of the coverlet!
As a follow-up treatment of the coverlet:
- Do not bleach.
- Do not iron.
- Do not dry clean.
Hygiene
requirements of
the operator
8.2 Disinfection
The operator must be notified about which measures apply to the
AVA Activity Analytics System and the actual hygiene directives for
disinfection. The disinfection of the AVA Activity Analytics System or
parts of it can be performed only by trained personnel, who are familiar
with the hygiene requirements of the institution.
Disinfection
procedure
Disinfection Procedures
Please follow the procedure required by your local health authority.
CAUTION
For repair, please contact your local distributor.
Please follow the hygiene control regulations of your local
authority.
27
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics9
Care and Maintenance
9.1 Inspection
The safe operating condition of the AVA Activity Analytics System has
to be checked at each use by the operator or during use by the patients
and at least once in a year in particular with regards to the following:
• Function of the keys of the power unit.
• Function of the emergency CPR.
• Condition of the air hoses and quick coupling.
• Condition of the air cells.
• Condition of the coverlet.
• Condition of the sensors’ pad.
9.2 Maintenance
The air filter should be cleaned regularly. It should be checked often,
and depending on the usage environment may require to be changed
often.
(1) Power off the power unit and unplug the power cord set from the
socket.
new filter.
(2) Remove air filter from the rear panel and clean or replace with a
(3) The parts or accessories shipped with the ME equipment is 2 years.
(4) To prevent an unacceptable risk, all information necessary for
correct replacement of detachable or interchangeable parts shall be
available and replaced by qualified service personnel only.
(5) Following storage and/or transport of the device, please allow the
device to sit idle at room temperature for at least 3 hours before
powering on.
28
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics10
Troubleshooting
Problem
Control Procedure
Possible Solution
1.) The power unit is
working but the mattress
is not inflating.
1.1) Verify that air flows liberally
across the tubes and the mattress
manifold.
Check if there are any cuts, blockage
or breakages.
1.1) It may be necessary to move
the tubes or the manifold if they are
kinked or twisted. In case of cuts
or rips, replace the air cells or air
hoses.
1.2) Verify that the quick coupling is
correctly connected to the air outlets
of power unit.
1.2) Firmly connect the quick
coupling.
1.3) Verify that the CPR valve is
correctly closed.
1.3) Firmly close the CPR valve.
2.) The patient sinks
into the mattress.
2.1) Check the envelopment rate on
the power unit.
2.2) Check for any abnormal air loss
from the mattress.
2.1) Decrease the envelopment
rate via knob to make the mattress
harder.
2.2) Replace the components that
are abnormally losing air with an
authentic replacement part.
2.3) Check the air filter.
2.3) Clean or replace the air filter.
2.4) Verify that the CPR valve is
closed correctly.
2.5) Verify the manifold of the static
air chamber underneath air cells is
connected.
2.4) Firmly close the CPR valve.
2.5) Reconnect the manifold of the
air chamber.
3.) The power unit
cannot power on.
3.1) Verify that the power cord set is
plug into the proper socket.
3.2) Verify that the power cord set is
properly connected to the power unit.
3.1) Insert the power cord set of
power unit into an appropriate
socket and turn the power on.
3.2) Insert the power cord set into
the power unit and turn the power
on.
3.3) Verify that the power cord set is
not damaged.
3.3) Replace with a functioning
power cord set.
3.4) Verify that the fuses are not
burned out.
3.4) Contact the authorized
distributor for technical service.
3.5) The power unit is not responding
to the control procedures listed
above.
3.5) Contact the authorized
distributor for technical service.
4.) Failure indicator
4.1) Check if patient is bottoming out. 4.1) Reach out and touch the
mattress under the patient’s sacrum
to make sure it’s not bottoming out.
29
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics10
Troubleshooting
Problem
Control Procedure
Possible Solution
4.2) Check if the mattress is
insufficient pressure.
4.2) Check if there is any air loss
from air cell.
4.3) Check if the mattress is
excessive pressure.
4.3) Check if the mattress is too
hard.
4.4) Check if the power cord is loose. 4.4) Check the power cord is firmly
connect with power unit and wall
socket.
4.5) The alternating valve is not
working correctly.
4.5) Contact the authorized
distributor for technical service.
5) Wi-Fi disconnect fail 5.1) See Wi-Fi indicator LED is
amber.
5.1) Check you have set the Wi-Fi
connection between power unit, Wi-
Fi router and server via mobile APP.
(Please refer another IFU)
5.2) See Wi-Fi indicator LED is
blinking in blue.
5.2) Check the Wi-Fi router is on
and work well.
5.3) See Wi-Fi indicator LED is
blinking in white.
5.3) Check the server is on and
intranet connection work well.
6.) Initial calibration fail 6.1) Check patient is not on the
mattress before initial calibration
ready.
6.1) Remove patient carefully until
initial calibration ready or press “Max
inflate” to ignore the fail.
6.2) Check the mattress is placed flat
on the bedframe and all air cells are
not extrusion or bending.
6.2) Try to replace the mattress
again for a flat condition,
6.3) Check the air cell holder of
mattress is not folded.
6.3) Use hand to check the air cell
holder of the mattress.
7.) Sensor pairing fail
7.1) Check the transfer cable is
connected before inserting the power
cord set into a wall outlet.
7.1) Reconnect the transfer cable
with rapid connector of power unit
7.2) Remove power cord
7.2) Still see the failure indicator,
power LED is blinking in white,and
control panel shows the number via
digital number display.
*Number(N) could be 01~27
*Refer below sensor pad drawing
7.4) Reconnect the power cord
30
7.3) Check if the No.N sensor is
disconnected form the sensor board
cable of mattress sensor’s pad.
7.3) Push the cable into the sensor
board connector firmly and you
should feel a ”click”.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics10
Troubleshooting
Sensor Pad Assembly Configuration Drawing (Back View):
25
18
10
9
Right side
27
26
Head
24
19
23
20
17
11
16
12
15
13
8
7
6
2
3
4
1
Foot
22
21
14
5
Left side
31
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics11
Technical Data
Power unit
The AVA Activity Analytics System is suitable for continuous operation.
System Name.................................................AVA Activity Analytics
Model .........................................................................................SR396
Dimensions(W x H x D).............................339 x 266 x 130mm (±5mm)
Weight.............................................................................3.4Kg(±0.5kg)
Electrical Rating.....................................100-240Vac 50/60Hz 0.5-0.3A
Power Consumption...............................25W max. (normal operation)
Electrical Class............................................................Class II
Applied Part...............................................................Type BF mattress
IP Code......................................................................IP21
Rechargeable Coin Cell......................Li-Ion Type LIR2477
rated 3.7Vdc 200mAh
This system is not AP / APG protected.
NRTL_Safety Certified: SGS Q Mark in accordance with
ANSI/AAMI ES60601-1:2005+A1+A2 and CAN/CSA C22.2 No.60601-1:14
EMC & Safety & RF Certified Standard
Safety: IEC/EN 60601-1_v3.1 and AS/NZS IEC 60601.1:2005
HomeCare: IEC/EN 60601-1-11_v2.0
EMC: IEC/EN 60601-1-2_v4.0
RF: FCC Part 15C and EN 300328 and AS/NZS 4268:2017
Operating Conditions
Temperature Range: 5°C to 40°C
Relative Humidity Range: 15% to 90%
Atmosphere Range: 700hPa to 1060hPa
Mattress
replacement
Min. Patient Weight ......................................................................30Kg
Max. Patient Weight for Entrix Lux..............................................180Kg
for FIT.........................................................250Kg
Material of Air Cells.......................Nylon with TPU Iamination material
The AVA Activity Analytics System must be decontaminated before
disposal.
Disposal of old electrical and electronic equipment - valid in the
European Union: WEEE Directive 2012/19/EU.
This symbol on the product or on its packaging indicates that this
product should not be treated as household waste. Instead, this product
should be taken to the appropriate place of disposal for the recycling of
electrical waste and electronic equipment.
32
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics12
EMC Declaration
Declaration of Conformity
For EN 60601-1-2 (4th Ed.)
Company Name:
Carilex Medical, Inc.
Company Address:
Product Name:
No. 77, Keji 1st Road, Guishan District, Taoyuan City 33383, Taiwan,
R.O.C.
AVA Activity Analytics System
Model No.:
SR396
Report Number:
ETC 21-01-RBO-054-01
Power Supply:
100-240Vac 50/60Hz 0.5-0.3A
Recommended separation distances between
portable and mobile RF communications equipment and the ME equipment
The AVA Activity Analytics System is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the AVA Activity Analytics System can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AVA
Activity Analytics System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d=
P
5,3
0.1
V
1
0.4
1.2
3.7
11.7
d=
5,3
E
1
P
0.1
0.4
1.2
3.7
11.7
d=
7
E
1
P
0.2
0.7
2.3
7.4
23.3
0.01
0.1
1
10
100
Declaration – electromagnetic emissions
The AVA Activity Analytics System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AVA Activity Analytics System should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
The AVA Activity Analytics System uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
The AVA Activity Analytics System is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
Complies
33
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics12
EMC Declaration
Declaration – electromagnetic emissions and immunity –
for EQUIPMENT and SYSTEMS that are use in the professional healthcare facility
environment or in the home healthcare environment
The AVA Activity Analytics System declaration – electromagnetic immunity
The AVA Activity Analytics System system is intended for use in the electromagnetic environment specified below.
The customer or the user of the AVA Activity Analytics System system should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the EQUIPMENT or SYSTEM
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Interference may occur in the vicinity of equipment marked
with the following symbol.
3 Vrms ; 6 Vrms
150 kHz to 80 MHz
3 V/m ; 10V/m
80 MHz – 2.7 GHz
80%
27 V/m
28 V/m
9 V/m
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields
from RF wireless
Communications
equipment
IEC 61000-4-3
3 Vrms ; 6 Vrms
150 kHz to 80 MHz
10V/m
80 MHz – 2.7 GHz
80%
385 MHz 27 V/m
450 MHz 28 V/m
710 MHz 9 V/m
745 MHz
780 MHz
810 MHz 28 V/m
870 MHz
930 MHz
1720 MHz 28 V/m
1845 MHz
1970 MHz
2450 MHz 28 V/m
5240 MHz 9 V/m
5500 MHz
5785 MHz
385 MHz
450 MHz
710 MHz
745 MHz
780 MHz
810 MHz
870 MHz
930 MHz
1720 MHz
1845 MHz
1970 MHz
2450 MHz
5240 MHz
5500 MHz
5785 MHz
28 V/m
28 V/m
28 V/m
9 V/m
Declaration – electromagnetic immunity
The AVA Activity Analytics System system is intended for use in the electromagnetic environment specified below.
The customer or the user of the AVA Activity Analytics System system should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV
air
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV
air
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Mains power quality should be that of a
typical commercial or hospital environment.
±0.5 kV
±1 kV differential mode
±2 kV common mode
0 % UT ; 0 , 5 cycle
At 0o , 45o , 90o , 135o , 180o ,
225o , 270o and 315o
0 % UT ; 1 cycle
and
70 % UT ; 25/30 cycle
Single phase: at 0o
±0.5 kV
±1 kV differential mode
±2 kV common mode
0 % UT ; 0 , 5 cycle
At 0o , 45o , 90o , 135o , 180o ,
225o , 270o and 315o
0 % UT ; 1 cycle
and
70 % UT ; 25/30 cycle
Single phase: at 0o
30 A/m
30 A/m
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended that
the EQUIPMENT or SYSTEM be powered
from an uninterruptible power supply or a
battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
34
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity AnalyticsU-2S2006-30171-G V1.0 2021/07/23
1 | FCC Confidentiality 0727 | Cover Letter(s) | 122.52 KiB | August 02 2021 / August 03 2021 |
carilex 7 2AZIZSR396 Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation T, Cw k >02/. 716 (signed by FCC listed Grantee contact or authorised agent) Carilex Medical, Inc. No. 77, Keji 1st Road, Guishan Dist., Taoyuan City 33383, Taiwan Date: 16/07/2021 TUV SUD BABT TCB Octagon House, Segensworth Road, arclasyarcleee Hampshire, mOhtoneladm Confidentiality Request olen |B Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, Carilex Medical, Inc. hereby requests permanent confidential treatment of information accompanying this application as outlined below:
The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Name: K.T. Nien Title: PR EMC & Safety Senior Engineer
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-08-03 | 2412 ~ 2472 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-08-03
|
||||
1 | Applicant's complete, legal business name |
Carilex Medical, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0030777395
|
||||
1 | Physical Address |
No.77, Keji 1st Road, Guishan Dist.
|
||||
1 |
Taoyuan City, N/A
|
|||||
1 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
a******@tuvsud.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AZIZ
|
||||
1 | Equipment Product Code |
SR396
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K******** N********
|
||||
1 | Title |
PR_EMC &Safety Senior Engineer
|
||||
1 | Telephone Number |
88633******** Extension:
|
||||
1 | Fax Number |
88633********
|
||||
1 |
k******@carilexmedical.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | AVA Activity Analytics System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is conducted. This device has 20 and 40 MHz BW modes. The antenna used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons. End users must be informed of the requirements for satisfying RF Exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Taiwan Testing and Certification Center Linkou Lab
|
||||
1 | Name |
N******** L******
|
||||
1 | Telephone Number |
886-2******** Extension:
|
||||
1 | Fax Number |
+886-********
|
||||
1 |
n******@etc.org.tw
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2472.00000000 | 0.2172700 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC