Wellell 9P-086520 User manual

Op
tima Auto
Op
tima Auto Link
User Manual


CONTENTS
ENGLISH
USER MANUAL 1
ESPAÑOL
MANUAL DE INSTRUCCIONES 27
PORTUGUÊS
INSTRUÇÕES DE UTILIZAÇÃO 55
FRANÇAIS
INSTRUCTIONS D'UTILISATION 83
DEUTSCH
GEBRAUCHSANLEITUNG 111
DUTCH
MANUALE DI ISTRUZIONI 141
ITALIANO
GEBRUIKERSHANDLEIDING 169
Model No.: 9P-086520
PLEASE READ ALL INSTRUCTIONS BEFORE USE

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IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE USING
DANGER - To reduce the risk of electrocution:
(1). Always unplug this product immediately after using.
(2). Do not use while bathing.
(3). Do not place or immerse the unit into water or other liquids.
(4). Do not reach for a product that has fallen into water. Unplug immediately.
WARNING - To reduce the risk of burns, electrocution, fire, or injury to
persons:
(1). Evaluate patients for entrapment risk according to protocol and monitor patients appropriately.
(2). The product may be used with caution for patients with spinal injury, but suggested to consult with
physician before use. However, it should not be used for patients with unstable spinal fractures.
(3). Close supervision is necessary when this product is used on or near children. Electrical burns or
choking accident may result from a child swallowing a small part detached from the device.
(4). Use this product only for its intended use as described in this manual. Do not use other mattress not
recommended by the manufacturer.
(5). Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been
dropped or damaged, or dropped into water. Return the product to your supplier or Wellell Inc. for
examination and repair.
(6). Keep the cord away from heated surfaces.
(7). Never block any air openings of this product or place it on soft surfaces, such as a bed or couch, where
openings may be blocked. Keep the air opening free of lint, hair, and other similar particles.
(8). Never drop or insert any object into any opening or hose.
(9). No modification of this equipment is allowed unless it is conducted by the authorized technician.
(10).Mattress covers have passed skin sensitization and skin irritation test. However, If you suspect that
you may have had or are having an allergic reaction, please consult a physician immediately.
(11).Do not leave long lengths of tubing around the top of your bed. It could lead to strangulation.
(12).Keep the pump away from flammable liquids or gases.
(13).Do not use the extension cord for a long time.
(14).When disposing the unit because of damage or failure, you must comply with the regulations of your
particular region or country for disposing of such equipment.
(15).Medical electrical equipment needs to special precautions regarding EMC and needs to be installed
according to EMC information. Contact your service provider or manufacturers regarding EMC
installation information.
(16).If there is a possibility of electro-magnetic interference with mobile phones, please increase the
distance (3.3m) between devices or turn off the mobile phone.

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CAUTION – Reducing the risk of damage to the device.
(1). Mobile RF communications equipment can affect medical electrical equipment.
(2). Make sure the filter area at the back of the device is not blocked.
(3). Do not place the device directly onto flammable materials.
(4). The equipment must not be covered or positioned in such a way that the operation or performance
of the equipment is adversely affected.
(5). Be careful not to place the device where it can be taken or touched by children and pets.
(6). Store the product in a dry place. Keep out of direct sunlight. Use of or store the product only in the
following conditions:
Operation: 10°C to 40°C (50°F to 104°F); 10% to 90% non-condensing
Storage: -15°C to 50°C (5°F to 122°F); 10% to 90% non-condensing
(7). Connection of OUR PRODUCT to 4G LTE NETWORK that includes other equipment could result in
previously unidentified RISKS to PATIENTS, OPERATORS or third parties. The USER should identify,
analyze, evaluate and control these RISKS. Subsequent changes to the 4G LTE NETWORK could
introduce new RISKS and require additional analysis. Changes to the 4G LTE NETWORK include the
following:
changes in the 4G LTE NETWORK configuration;
connection of additional items to the 4G LTE NETWORK;
disconnecting items from the 4G LTE NETWORK;
update of equipment connected to the 4G LTE NETWORK; and
upgrade of equipment connected to the 4G LTE NETWORK.
NOTE, CAUTION AND WARNING STATEMENTS:
NOTE - Indicate some tips.
CAUTION -Indicate correct operating or maintenance procedures in order to prevent damage to or
destruction of the equipment or other property
WARNING - Calls attention to a potential danger that requires correct procedures or practices in order to
prevent personal injury.

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SYMBOLS
Authorized representative in the
European community.
Temeprature Limitation
Manufacturer
Dry clean, Any Solvent Except
Trichloroethylene
Complies with standards
protecting against electric
shock for type BF equipment.
Do Not Iron
Consult operating instructions
for use
Tumble Dry, Normal, Low Heat
Attention, should read the
instructions.
Do Not Tumble Dry
Attention, should read the
instructions.
Do Not Bleach
Do Not Dry Clean
Machine wash, regular / normal, 95
degrees C (203 degrees F)
Class II
EC directive medical device label
(Compliance to MDD 93/42/EEC; 4
digits number is NB’s number)
FCC logo
Protected against solid foreign objects of 12.5 mm and greater; Protection against
vertically falling water drops
Attention – Observe proper Disposal of Electrical & Electronic Equipment (WEEE):
This product should be handed over to an appropriate collection point for the
recycling of electrical and electronic equipment. For more detailed information
about the recycling of this product, please contact your local city office, household
waste disposal service or the retail store where you purchased this product.

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1. Introduction
This manual should be used for initial set up of the system and for reference purposes.
1.1. General Information
The system is a high quality mattress system suitable for treatment and prevention of pressure injury.
This is a micro-processor controlled device. It features the illuminated LCD display.
The system has been tested and successfully approved to the following standards:
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 61000-3-2 Class A
IEC/EN 61000-3-3
CISPR 11 Group 1, Class B
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the IEC/EN
60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a
typical medical 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 other
devices in the vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to other devices, 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 device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
Consult the manufacturer or field service technician for help.
1.2. Intended Use
This product is intended to help and reduce the incidence of pressure injuries while optimizing patient’s
comfort. It can support patient up to 250 kg (550 lb). And It can also provide the following purposes:
For long term home care of patients suffering from pressure injury.
For pain management as prescribed by a physician.
The product can only be operated by personnel who are qualified to perform general nursing
procedures and have received adequate training in knowledge of prevention and treatment of pressure
injury.
NOTE- Equipment is not suitable for use in the presence of flammable anesthetic mixture with air
or with oxygen or nitrous oxide.

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2. Product Description
Unpack the box to check for any damage which may have occurred during shipment. If there are
damages, please contact your dealer immediately.
2.1. Contents
This system comes with the followings items.
Unpack this box by removing the device and its accessory and checking for any damage, which may
have occurred during shipping. If there are damages, please contact your service provider immediately.
(1). Pump
(2). AC power cord
(3). Mattress
(4).
Air filter
(5).
User manual
The SIM card is pre-installed and bound to your device. Contact your service provider if it requires
replacement.
NOTE: The content of standard package might vary or change without advanced notification.
CAUTION: Patient should not connect the device to a personal computer for data downloading.
This may cause device failure.

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2.2. Pump and Mattress System
CPR
Pump unit
Mattress system
Quick connector
Position sensor
2.3. Pump Unit
Front
Quick connector
Position sensor
Front panel
Rear
Mounting brackets
USB cover
SIM card slot
Air filter
Battery cover
Power socket
Fuse
Power switch

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2.4. Front Panel
(1). Power Key
Power Key is to turn on and turn off pump.
(2). Panel Lock key
User interface will be locked automatically 5 minutes after last operation. To unlock interface,
press and hold Panel Lock key for 1 second.
NOTE- Always unlock user interface before turning off the pump.
(3). Max Firm key
This key is to make sure mattress can be reached maximal operating pressure. This mode will
last for 20 minutes and then return to previous setting automatically. This function can be used
during patient transfers or nursing procedures for better support. To disable this function, please
press Max firm key again.
(4). LCD & Knob
Knob is to choose and confirm setting displayed on LCD, rotate
the knob and press once to select the setting mode desired in the
highlight.
(5). Alarms and alarm mute key
When there is an alert situation happened, the LCD screen will display a corresponding error
code with an audible buzzer in an interval of a few seconds. The buzzer can be temporarily
suspended by pressing the Alarm Mute key. Alarm buzzer will signal repeatedly every 3 minute
until the alert situation is resolved.
Below presents 2 types of alarm and please refer to the attached error code table for details.
(6). Signal icon (FOR IOT DEVICE ONLY)
This appears ONLY on the IoT-technology-enabled device. The icon shows signal strength. Make
sure to place the device at where the signal coverage is sound.
Note: The IoT (Internet of Things) function is ON automatically when the system is activated.

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3. Installation
3.1. Pump & Mattress
NOTE- Unpack the box to inspect for any damage which may have occurred during shipment.
If there are any damages, please contact your dealer immediately.
(1)
(2)
(3)
(4)
(5)
(6)
(1). Place the mattress on top of bed frame and foot print toward foot end. Secure the mattress firmly by
fixing the straps to bed frame to ensure mattress will be free from sliding. Securing straps are located
on the base of the mattress
NOTE- Make sure that ALL the Relief kbobs and emergency CPR knob are closed and locked in
position.
CAUTION- Placing another layers of sheet or bed linen between the patient and the mattress
may reduce the benefits provided by the mattress and should be avoided at all time.
(2). Hang the pump onto bed panel at the foot-end and adjust hangers to hang the pump to best upright
position, or place the pump on a flat surface.
(3). Connect the air hose connector of air mattress and the electrical cord of position sensor to the pump
unit. Make sure the air hose connection is completed and secured when a "click" sound is felt or heard
and position sensor assemble the alignment with the arrow pointing up.
NOTE- Check and ensure the air hose is not kinked or tucked under mattress.
NOTE- Auto recognition mattress of Optima Auto or Optima Prone.

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(4). Plug the power cord into electrical outlet.
NOTE- Make sure the pump unit is suitable for the local power voltage.
NOTE- The plug is also served to stop the device.
NOTE- Pump might still be in operation after the power cord disconnection if optional battery
is built-in.
(5). Turn the power switch to ON position.
CAUTION- The pump can only be applied to the mattress recommended by the manufacturer.
Do not use it for any other purpose. (Applied part: air mattress) Do not position the equipment
so that it is difficult to operate the disconnecting device.
CAUTION- Allow the mattress to inflate before positioning the patient on the mattress.
(6). The cable management tape is provided along the side of the mattress to manage power cord. Please
make sure the wire has no signs of damage. After installation, extra length of the power cord, if any,
should be neatly managed to prevent stumble accident and should be clear of moving bed
mechanisms or other possible entrapment areas.
NOTE- The EQUIPMENT should be firmly placed at position where users can easily access to.
3.2. Position Sensor- installation & removal
Position sensor is key to auto seat inflation. It allows the mattress
automatically to inflate when the head section has been raised to prevent
bottoming out.
To initiate this function, you should connect the sensor cord to the unit.
To
Steps
Illustration
Attach
(1). Align the arrows on the cord and the unit.
(2). Insert the cord accordingly as illustrated.
Detach
(1).
Put your fingers at the end of the cord as illustrated.
(2). Pull backward to detach it from the unit.
Note: The grey area is the protection mechanism that
prevents misuse and enables a proper detachment by
sliding it backward.
Warning: Do not immerse in water.

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4. Operation
NOTE- Always read the instructions before use.
4.1. General Operation
Switch the power switch on the side of the pump and press power key to turn it on.
4.1.1. Pre-set program
(1). Choose “TICK” and press the knob to enter the pre-set program, and then the pump will run itself
automatically.
Perform pre-set program:
Mode Alternating
Cycle time 10 mins.
(2). Enter setting to set your prefer Mode and Cycle time.
(3). Once the pump identifies the size of the mattress via the quick connector, it starts to inflat the
mattress. The initial inflaction takes about 30 minutes.

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(4). After initial inflation, the system sets off to detect the patient's weight in order to provide
corresponding pressures for better mattress pressure relieving performance.
NOTE- Place the patient on the mattress ONLY after the initial inflation is completed, better
when the auto adjustment is about to start.
The 5 blue bars displayed on the screen represents the status of the
automatic adjustment detection. When completes, the 5 bars will
stop running and become .
NOTE- Once the patient is on the mattress, the pump will automatically sense and adjust the
pressure in the cells to support the patient.
NOTE- Press the knob for at least 3 seconds to quickly initiate the auto adjustment process.
(5). The current therapy mode is shown the LCD display. Turn the knob clockwisely or counter-
clockwisely to change settings. Press the knob when your prefer selection is hightlighted to enter or
confirm the setting.
Mode
Cycle time
Tuning
A. Mode
Alternating
Continuous Low Pressure
Back to previous page
NOTE- Review the patient’s monitoring and reposition program before you change the
operation mode.
B. Cycle time

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10 mins 15 mins 20 mins 25 mins Back to previous page
C. Tuning
Original
setting
Decrease mattress
pressure
Increase mattress
pressure
Back to previous
page
NOTE- The pressure in the air cells can be manually adjusted for patient comfort by entering
the tuning mode in the lower right corner of the LCD screen.
NOTE- Slide one hand underneath the air cell where the patient’s buttock locates to ensure
that the given air pressure is appropriate. Always leave a space for about 2.54 cm (1 inch)
between the patient and the cell to prevent bottoming-out.
4.2. Internet of Things Service (IoT, available only with Optima Auto Link)
The Optima Auto Link is an IoT-technology-enabled device. This IoT device streams the pump or
mattresses’ real-time conditions via a cloud-based platform named KeepWell.
For the IoT device, the LCD displays a signal icon that shows the
current strength.
For more detail, please refer to the manual of the cloud-based
platform: “KeepWell—streamline operation, logistics, and customer service for your business.”
NOTE- Use this device in places where 4G LTE NETWORK coverage is good to ensure optimal
IoT services.
NOTE- Consult with the service provider or the manufacturer for the cellular communication
service provider.
4.3. Emergency CPR Operation
CPR knob is located at the patient’s left-hand side of the
mattress near the head area. When there is a need to perform
CPR on the patient, quickly turn the CPR knob to release air
from mattress. The quick connector on the pump unit can be
disconnected for even faster deflation.

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4.4. Relief Function
The 5 knobs are on the patient’s left-hand side at the foot end of the mattress. Turning the knob to
deflate the cell enables the caregivers to float the patient’s heels and take away the pressure from bony
prominences.
For permanent off-loading/pressure relief:
Select
no more than two
cells directly under the
area that desired to relieve.
Rotate the knob in a counterclockwise direction
to the 12 o'clock position to deflate the cell.
NOTE- This one to two cells can be left permanently deflated.
NOTE- Deflating more than two adjacent cells may affect the support of the patient during the
normal alternating cycle.
4.5. Evacuation Handles
NOTE- When an emergency occurs, the designated
handles can be used for caregivers to quickly and
safely evacuate the patient from the bed in the
facility.
4.6. Transportation
NOTE- When there is a need of patient transportation,
pump with the power cord can be disconnected from
the mattress during transport. For optimum comfort,
WELLELL recommends caregivers to change to
Continuous Low Pressure mode and wait for 5 minutes
before disconnecting. Cap on the quick connector as
shown on the left to keep the air inside the mattress. The
mattress remains inflated at least 24 hours depending
on the setting. Optional battery model can support at
least 6 hours of treatment mode.

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4.7. Battery/filter replacement
The device requires battery/filter replacement. Your service provider shall provide the replacement
service.
The filter: every 6 month The battery: every 2 year
4.8. Built-in batteries
For model with built-in batteries, it provides non-stop 6-hour therapy when in power outage. You can
refer to top-right side of LCD display for battery status. Please read information below for battery
operation.
(1). Use AC power whenever possible. Connect the pump to AC power outlet and turn on the power
switch to fully charge the battery for emergencies.
(2). The warranty period is 6 months for the built-in batteries.
(3). Connect the pump to AC power outlet immediately when the low-battery graphic shows up.
(4). The battery may not be fully charged upon receipt. Connect the pump to AC power outlet for at least
10 hours.
NOTE- Pump can not complete initial inflation when battery capacity is under 25%.
4.9. Cellular communication (FOR IOT DEVICE ONLY)
The IoT device uses the 4 G LTE NETWORK that transmits the device’s data to your service provider
wirelessly.
(1). The 4G LTE NETWORK is activated when the system is turned on by default.
(2). The icon displayed at the top left of your screen indicates signal strength. Use this device in places
where 4G LT E NETWORK coverage is good to ensure optimal IoT services.
(3). The data is automatically transmitted to the service provider. In order to make sure that your data is
transferred, leave your device connected to the power outlet at all times.
Note- Data might not be transmitted if you use it outside of the country or region of purchase.
Note- Devices with cellular communication might not be available in all regions.
Note- Please be aware that within the wireless network, the availability and quality of the
network may be affected by terrain, buildings, and the weather.
Note- Consult with the service provider or the manufacturer for the cellular communication
service provider.

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5. Cleaning
It is important to follow the cleaning procedures to avoid cross contamination. Be sure to clean the
surface in a dry and dust free environment. Wipe down the pump unit with a damp cloth pre-soaked
with a mild detergent. Avoid contact with dust and proximity to dusty areas. Make sure that any cleaning
agents you use will not harm or corrode the plastic casing on the pump unit. If your doctor or medical
facilities have other special cleaning instruction, please follow the professional instruction.
CAUTION - Do not immerse or soak pump unit/position sensor.
WARNING-Do not remove the casing of the pump to avoid electrical shock. All disassembly or
repair should be done by authorized technicians.
CAUTION- The pump does not need oil lubrication; please do not dissemble the system.
Cover Material:
Stretch
Cover Material:
Nylon/PU
Wipe-down the mattress unit with a damp cloth pre-soaked with warm water containing a mild
detergent, or chlorine bleach followed by an approved intermediate level disinfectant. Also the mattress
top cover can be completely removed for laundry with water temperature indicated on the laundry
label; however, it is recommended that the user still check with local policy to determine the
time/temperature ratio required achieving thermal disinfection. The cover may also be cleaned using
sodium hypochlorite diluted in water. After cleaning, please avoid dust and proximity to dusty areas and
all parts should be air dried thoroughly before use.
CAUTION- Do not use phenolic based products for cleaning.
CAUTION- Keep mattresses out of direct exposure to sunlight, and make sure to dry the
mattress after cleaning.
CAUTION- Make sure to execute the cleaning procedure every time before a new patient lying
on the air mattress.
6. Storage
(1). To store the mattress, lay the mattress out flat and upsides down.
(2). Roll from the head end towards the foot end with CPR valve open.
(3). Foot-end strap can then be stretched around the rolled mattress to prevent unrolling.
(4). After the product is stored for 3 months, it needs to be recharged again if optional battery is built-in.
NOTE- Do not kink, crease or stack the mattresses and do not store the system in direct
sunlight, high temperature or moist areas.

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7. Maintenance
7.1. General
(1). Check main power cord and plug if there is abrasions or excessive wear.
(2). Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are stubbed
together correctly.
(3). Check airflow from the quick connector. The airflow should alternate between two ventilation tubes
in the middle and the other two at the bottom of quick connrector every half-cycle time if it's in
alternating mode.
(4). Check the air hoses if there is kink or break. For replacement, please contact local representative or
place of purchase.
7.2. Fuse Replacement
(1). Disconnect the power plug when a blown fuse is
suspected.
(2). Remove the cover of the fuse holder by means of a flat
screwdriver.
(3). Insert a new fuse of the correct rating in, and replace the
cover of the fuse holder back. The fuse should be rated
as T1AL/250V type and VDE approved.
7.3. Air Filter Replacement
(1). Open the air filter cap located at the back of pump.
(2). Replace with a clean filter and put the cover lid back. The filter
is reusable and can be washed gently with a mild detergent
and water. Dry the filter before use.
(3). Check and replace air filter regularly if environment is dirty.
Suggested to do it every six month.
8. Expected Service Life
The products are intended to offer safe and reliable operation when use or installed according to the
instructions provided by Apex Medical. Apex Medical recommends that the system be inspected and
serviced by authorized technicians if there are any signs of wear or concerns with device function and
indication on products. Otherwise, service and inspection of the devices generally should not be
required.

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9. Trouble Shooting
9.1. User tackle-able issues
Issues that users might encounter and solve by themselves. See below for the description,
corresponding display and solutions.
(1). Low Pressure Alarm
Alarm will be indicated when the pump detects low pressure condition within the mattress.
NOTE- In alternating mode, the system first inflates and then has the cells hold at a certain
level to support the patient while monitoring the cells at the same time. The situation
continues until the low pressure alarm is lifted.
NOTE- The pump seals the air inside the mattress, which temporaily keeps the patients from
bottoming out during low pressure condition. Patient should be moved if the power failure
issue cannot be solved soon.
(2). Low battery capacity
NOTE- When low battery symbol is shown on the display, plug the power cord into the wall
outlet immediately.
CAUTION- Pump system will stop running; the LCD displays the alarm, along with the
buzzer images when the battery capacity is blow 10%. To restore the system, plug the
power cord into the wall outlet, and press the power key to restart the pump.
Code No.
Diagram
Description
What to Do
01, 02, 05
Low pressure alarm:
body section (1).Check all the joint
parts to see if they are
well connected, or if
there is leakage, along
with kinked or broken
parts that need to be
addressed.
(2).Call for service if the
problem persists.
03, 04, 06
Low pressure alarm: foot
section
07
Low pressure alarm:
head section
19
Position sensor is not
connected
Re-start the pump to fix
this. Call for service if the
problem persists.
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