Apex Digital Sedens 500 Manuale utente

Tipo
Manuale utente
Sedens 500
User’s Manual
CONTENTS
ALTERNATING PRESSURE REDISTRIBUTION SYSTEM
USER’S MANUAL 1
SISTEMA DE REDISTRIBUCIÓN DE PRESIÓN ALTERNA
MANUAL DE INSTRUCCIONES 20
SISTEMA DE REDISTRIBUIÇÃO DE PRESSÃO ALTERNADA
INSTRUÇÕES DE UTILIZAÇÃO 39
SYSTÈME DE REDISTRIBUTION À PRESSION ALTERNÉE
INSTRUCTIONS D'UTILISATION 58
ALTERNIERENDES DRUCKUMVERTEILUNGSSYSTEM
GEBRAUCHSANLEITUNG 77
ALTERNEREND DRUKSYSTEEM
GEBRUIKERSHANDLEIDING 96
SISTEMA DI RIDISTRIBUZIONE A PRESSIONE ALTERNATA
MANUALE DI ISTRUZIONI 115
MODEL NO.: 9P-048560
Please read the manual before use
Sedens500/English 1
IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE OPERATING THIS DEVICE.
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 store this product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. 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 facility protocol and monitor patients
appropriately.
2. The product may be used 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 Apex Medical Corp. for examination and repair.
6. Keep the cord away from heated surfaces.
7. Never block the air openings of this product or place it on a soft surface, 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. Do not modify this equipment without authorization of the manufacturer.
10. Cushion 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.
CAUTION: 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.
Sedens500/English 2
NOTE, CAUTION AND WARNING STATEMENTS
NOTE: Indicates some tips.
CAUTION: Indicates 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.
SYMBOLS
Authorised representative in the European community.
IPX2
For equipment with carry bag (protection against nearly vertically falling
water drops)
IP2X
For equipment without carry bag (protection against solid foreign objects of
12.5mm and greater)
Class II
Manufacturer
Complies with standards protecting against electric shock for type BF
equipment.
Consult operating instructions for use
Temperature limitation/Temperature Range
Machine wash, regular/ normal, 95 degree C (203 degrees F)
Do Not Bleach
Do Not Iron
Do Not Dry Clean
Tumble Dry, Normal, Low Heat
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.
KEEP THIS MANUAL FOR REFERENCE
Sedens500/English 3
INTRODUCTION
1.
This manual should be used for initial set up of the system and for reference purposes.
1.1 General Information
The device is a high quality, affordable pressure relief seat cushion system for wheelchair
users. It helps to decrease the concentrated pressure, distribute the pressure over the entire
contact interface and stimulate capillary blood flow for the prevention of pressure ulcers.
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
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 ulcers while optimizing patient comfort.
for long term home care of patients suffering from pressure ulcers.
for pain management as prescribed by a physician.
The product can only be operated by personnels who are qualified to perform general nursing
procedures and has received adequate training in knowledge of prevention and treatment of
pressure ulcer.
NOTE: Equipments are not suitable for use in the presence of flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
Sedens500/English 4
2.
Product Description
The device is an active alternating pressure seat cushion system and consists of a
reliable pump and seat cushion providing the best pressure relief. It comes equipped
with a fully digitalized pump and each function mode can be adjusted individually, such
as cycle time and comfort range. It provides you with total pressure management control
and runs on AC power supply or a Li-ion rechargeable battery.
2.1 Pump and Seat Cushion System
1. Pump Unit
2. Cushion
3. Control Panel
4. DC Power Jack
5. Air hose port
6. DC Plug
7. AC/DC Adaptor
8. Battery pack stored area
6
7
8
3
4
5
2
1
Sedens500/English 5
CAUTION:
1.
Do not drop water on to the device.
2.
Do not apply shock to the device.
3.
Do not disassemble or modify the device.
4.
Do not obstruct the air outlet.
5.
Do not use any power adapter and battery pack not provided by the manufacturer.
6.
To prevent battery pack damage, please remove the battery pack from the battery
compartment when not using the device for a long period.
2.2 Front Panel
1. Therapy Modes
To switch the therapy mode:
A. Alternating Mode
Continuously and sequentially inflate and deflate air cells to remove constant pressure
and facilitate improved cellular perfusion.
B. Static Mode
Provides a stable all cell inflated surface at lower pressure when compared to the
respective comfort level in alternative mode. The system then redistributes patient weight
over a greater surface.
2. Cycle Time
To adjust the pressure alternating cycle time to 10, 15 or 20 minutes..
3. Comfort Setting
To adjust the comfort level according to users preference or doctor’s advice. There are 5
different comfort levels: 1 is the softest & 5 is the firmest. The default setting is at
comfort level 1.
Sedens500/English 6
NOTE: A hand check is needed to determine if patient is bottoming out. When a patients
condition has significantly changed reassess appropriateness of product and
comfort setting level
4. Alarm Mute
Press alarm mute button to temporary suspend the alarms. Should the problem continue,
the alarms will resound within 10 minutes to notify the caregiver until resolved.
5. Low Battery Indicator
A low battery alarm indicates approximately 1 hours of therapy remain; charge batteries
IMMEDIATELY to prevent disruption of therapy. When battery is charged, audible and visual
alarms will turn off.
6. Low Pressure Indicator
When the pressure is below setting pressure, the Low Pressure indicator will light up
along with audio alarm. Please check if all connections are connected properly as per
instructions. If the pressure level is consistently low, check for any leakage (tubes or
connecting hoses). If necessary, replace any damaged tubes or hoses or contact local
qualified dealer for repairment.
NOTE: Even when pressing the Alarm Mute, the indicator light will stay on until the problem
is solved.
7. On/off
To turn the pump unit on/off.
8. Battery Charge Indicator
When the indicator light is on, AC power is charging the battery. The typical charging
period is approx.. 4.5 hours. The led light will be off once the battery is full.
Sedens500/English 7
3.
Installation
1
2
3
4
NOTE: Unpack the box to inspect for any damage, which may have occurred during
shipping. If there are any damages, please contact your dealer immediately.
3.1 Setting Up
1.
Place the seat cushion on top of the (wheel) chair. The slip-resistance mat found at the
bottom of cushion will prevent slippage.
CAUTION: The pump can only be used with the air seat cushion recommended by the
manufacturer. Do not use it for any other purpose.
2. Put the pump into the carry bag and hang the pump onto the (wheel) chair handle or frame
with the straps of the carry bag..
3. Connect air hose from the seat cushion to the pump unit.
NOTE: Check and ensure the air tubes have no kinks in them and are not tucked under the
cushion.
4. Connect the AC/DC adaptor to DC power jack of the pump unit. Plug into mains electrical
outlet..
NOTE: Use only with original manufacturer’s adaptor, improper use of adaptor or charge
with adaptors other than supplied from the manufacturer will not be covered under
the warranty.
Sedens500/English 8
NOTE: The plug also serves to disconnect the device. The system can operate in battery
mode only when the DC Plug is disconnected from the pump unit.
5.
Press the power button to start the machine. When the pump unit is turned on, the ON/OFF
indicator will light up
3.2 Charging Battery Pack
The Sedens 500 Pump Unit is battery-operated to facilitate patient mobility.
1.
Depending on how long you store your device, it may be in a low-battery state when you
remove it from long-term storage. After its removed from storage, it may require 4.5
hours of charging with the original adapter to fully charge the battery.
CAUTION: Its especially important to avoid charging your device under temperatures
higher than 104° F (40° C), which can permanently damage device.
2.
When the power in the battery pack becomes low, the low battery indicator flashes to
indicate that only approx.1 hour of battery power remain. You must recharge the battery
pack by using AC power source.
NOTE: Replace the battery recommended by the manufacturer, if the performance
becomes undesirable. It is suggested that users
charge the battery pack fully at night and use the
pump during the next day.
3.
Please make sure the battery is fully charged as the battery charge indicator light turn
off.
NOTE: Regularly check the battery indicator on the control panel to determine the status
of the rechargeable battery.
NOTE: When low battery condition occurs, the Low Battery indicator will light up and the
pump will set off the audible alarm at the same time. To mute the alarm, simply
press the alarm mute button. However, it is a reminder that user must recharge the
battery pack or use AC power source immediately.
CAUTION:
1.
Please keep the battery pack out of the reach of children.
2.
The battery pack is a Li-ion rechargeable battery, which can explode if not properly
replaced, used, handled or disposed of.
3.
Dispose of the battery as required by local ordinances or regulations.
4.
If you plan to store your device for longer than six months, charge it to 50% every six
months.
Battery
Pack
Sedens500/English 9
4.
After the battery is fully charged, the pump has approx. 12 hours of operation time
without the adaptor.
CAUTION: If the charging time is over 5 hrs but the battery charge indicator still lights up,
please do NOT continue to charge the battery, and disconnect the adapter for
safety.
4.
Operation
NOTE: Always read the operating instruction before use.
4.1 Operating Instructions
NOTE: For first time use, please use the AC/DC adaptor to charge the battery while using
the system The typical charging period will be about 4.5 hours. Once the battery is
fully charged, the battery charge indicator light will turn off.
1
2
1.
Press the On button on the display panel to start the system.
2.
It will take a few minutes to inflate the cushion.
3.
Before cushion is fully inflated, accoding to the weight and height of the patient,
adjust the mode, cycle time, and comfort setting to the most suitable level without
bottoming out.
DISCONNECT
Sedens500/English 10
NOTE: Sometimes the Low Pressure indicator will light up and flash temporarily when
users leave the cushion. This is normal, as inner pressure of the cushion suddenly
changes when load changes.
NOTE: Should the battery fail to keep working for 12 hours, please check for air leakage
or tubing connections as it might reduce the performance of the battery
considerably.
CAUTION: Pump unit should always put in carrying bag to prevent drop damage of the
equipment.
Cleaning
5.
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 in liquids.
WARNING: Do not remove the housing of the pump to avoid the electrical shock.
All disassembly or repair should be done by professional technicians.
CAUTION: The pump does not need oil lubrication; please do not dissemble the system.
Cover Material : Stretch
Wipe-down the cushion 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 up to 95°C;
however, it is recommended that the user still check with local policy to determine the time/
temperature ratio required to achieve 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: After cleaning, dry the mattress without direct exposure of sunlight.
Sedens500/English 11
Carrying Bag
The carrying bag should be turned inside out and completely wiped down using disinfectant solutions.
Allow it to air-dry thoroughly. Once the inside is dry, turn it back and wipe down the outside of the bag with
disinfectant solutions.
CAUTION: Dry the Seat Cushion in SUNLESS area after cleaning.
6. Storage
1. Disconnect the air hose from the cushion to the pump.
2. Protect the air tube coupler by putting it inside of seat cushion.
3. Place the whole system into a protective bag.
CAUTION: For storage period more than 3 months, disconnect the Li-ion battery pack from
the pump and make sure the battery is partially charged. This will help to keep the
performance and life of the battery.
CAUTION: Do not store the system under direct sunlight, high temperature or moisture
area.
Sedens500/English 12
7.
Maintenance
7.1 General
1. Check main power cord and plug if there are abrasions or excessive wears.
2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are
stubbed together correctly.
3. Check the air hoses for any kink or break. For replacement, please contact your local
dealers.
7.2 Battery Pack Replacement
To replace the battery pack, follow the instructions below.
1. Remove the AC power source & disconnect the DC
plug.
2. Open the battery cover by removing the screw on the
back of the pump unit.
3. Take out the battery pack by pulling the cable
connector.
4. Plug in the new battery pack connector and insert
the battery pack.
5. Put the cover on and screw back.
6. Connect the pump to a power outlet using the
included cable and power adaptor to recharge the
battery.
Sedens500/English 13
CAUTION: It is prohibited to use the battery pack not from the vendor. The charging
function of the pump is designed for the battery pack only. The vendor will not
warranty any damage from another battery pack not supplied by the vender
NOTE: Higher temperature will shorten life of the battery pack, please keep the battery in a
cold place and avoid direct sunlight
NOTE: The Velcro serves to secure the battery for the purpose of ensuring the stability of
battery pack. It’s recommended to check if the Velcro is secured before putting the
cover back
WARNING: Lithium-ion battery, DO NOT disassemble or remove outer casing, short-circuit,
puncture, crush, incinerate or expose to heat source, due to risk of fire and
combustion.
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.
Sedens500/English 14
9. Trouble Shooting
Q.1
Q1 Power is not ON
Check if the plug is connected to mains.
Check if the power cord is well connected to the pump
To operate from battery, check if the DC plug is disconnected from the pump unit
Q2 Low Pressure Alarm is on (audible & visual)
Check if the connection between air tube connector to pump unit is tightly secured.
Check if all tubing connections along cushion are secured.
Check if there is any leakage from air cells
Q3 Cushion becomes too firm and pressure can't be lowered
The pressure is too firm for too long, release some air by disconnecting the air tube
connector and change to your preferred setting..
Q4 No air is produced from some air outlet of the air tube connector
This is normal since it is at alternating mode. Air outlets take turns to produce air during
their preset cycle time..
Q5 Low Battery Alarm is on (audio & visual)
Only approx.1 hour of battery power remain, it is a reminder that user must recharge the
battery pack and use AC power source immediately. To mute the alarm, simply press the
alarm mute button.
After the battery is fully charged (about 5 hours), the pump immediately has 12 hours of
continuous operation time. If it is unable to operate over 12 hours, the battery pack might
need to be replaced.
If the low battery indicator still lights up after it has been properly recharged for
approximately 5 hours, the battery pack might need to be replaced. Replacement required
after about 6 months.
If the above information does not solve your problems, please contact your local agent directly.
They might require a technician to take care the problem.
Sedens500/English 15
10. Technical specification
Item Specification
Power Source DC12V, 1250 mA by Adaptor
Power consumption 12V DC, 1150 mA
Device Dimension (L x W x H) 25 x 12.2 x 5.7cm or 9.8” x 4.7” x 2.2”
Device Weight 1.0 kg or 2.2lb (battery and adaptor included)
Environment
Atmospheric
Pressure
700 hPa to 1013.25 hPa
Temperature
Operation: 5°C to 40°C (41°F to 104°F)
Storage: -10°C to 45°C (14°F to 113°F)
Shipping: -10°C to 45°C (14°F to 113°F)
Humidity
Operation: 30% to 75% non-condensing
Storage: 10% to 75% non-condensing
Shipping: 10% to 90% non-condensing
Classification
Type BF, Class II, IP2X; IP22 (with carrying bag)
Applied part: Air Seat Cushion
Not suitable for use in the presence of a flammable
anaesthetic mixture (No AP or APG protection)
Pressure Range Five selectable settings
Cycle Time 10, 15, 20 minutes
Battery Pack
3.78V Li-ion Battery x2 (2.95Ah typical)
(recommended type HOVANOX METAL, SDI-30B-2S1P )
Battery Operation Time
Approx. 12 hours
Battery Recharge Time
Approx. 4.5 hours
Cushion Specification
Dimension (L x W x H) 43 X 43 X 10.2 cm or 17” x 17” x 4”
Weight 1.1 kg or 2.4lb
Max. Weight Capacity 120 kg
NOTE :
1.
The battery performance may be reduced if the device is stored in a hot environment.
2.
Consult the distributor or EU representative for other technical documents.
3.
Please follow national requirements to dispose of the unit properly
4.
The manufacture reserves the right to change product specification without prior notice.
Sedens500/English 16
Appendix A: EMC Information
Guidance and Manufacturer’s Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment specified below. The user of this device
should make sure it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment-Guidance
RF emissions
CISPR 11
Group1
The device uses RF ener
gy
onl
y
for its internal function.
Therefore, its RF emissions are very low and are not likel
y
to
cause any interference in nearby electronic equipment
RF emissions
CISPR 11
Class B
The device is suitable for use in all establishments,
includin
g
domestic establishments and those directl
y
connected to the public low-voltage power supply network
Harmonic emissions
IEC61000-3-2
Class A
Volta
g
e fluctuations /
Flicker emissions
IEC61000-3-3
Complies
Warning:
1.
The device should not be used ad
j
acent to or stacked with other e
q
ui
p
ment. If ad
j
acent or stacked use is
necessary, the device should be observed to verif
y
normal o
p
eration in the confi
g
uration in which it will be
used.
2. Use of accessories, transducers and cables other than those s
p
ecified or
p
rovided b
y
the
manufacturer of this equipment could result in increased electroma
g
netic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
3.
Portable RF communications e
q
ui
p
ment (includin
g
p
eri
p
herals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to an
y
p
art of the Pum
p
, includin
g
cables s
ecified b
the manufacturer. Otherwise, de
radation of the
erformance of this
equipment could result.
Sedens500/English 17
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of this device
should make sure it is used in such an environment.
Basic EMC
standard
Immunity Test Levels
Compliance
Levels
Electromagnetic
Environment-Guidance
Professional
healthcare
facility environment
HOME
HEALTHCARE
ENVIRONMENT
Electrostatic
Discharge (ESD)
IEC61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30 %.
Electrical fast
transient/ burst
IEC61000-4-4
±2kV for power supply line
±1kV for input/output line
±2kV for power
supply line
±1kV for
input/output
line
Mains power quality should be
that of atypical commercial or
hospital environment
Surge
IEC61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 1 kV line(s) to
line(s)
Mains power quality should be
that of atypical commercial or
hospital environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
Voltage Dips:
i) 100% reduction for 0.5 period,
ii) 100% reduction for 1 period,
iii) 30% reduction for 25/30 period,
Voltage Interruptions:
100% reduction for 250/300 period
100-240 V
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of this device requires
continued operation during
power mains interruptions, it
is recommended that the
device be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60Hz)
magnetic field
IEC61000-4-8
30 A/m 30 A/m 30 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Conducted RF
IEC 61000-4-6
3 Vrms
0,15 MHz – 80 MHz
6 Vrms in ISM bands
between 0,15 MHz
and 80 MHz
80 % AM at 1 kHz
3 Vrms
0,15 MHz – 80
MHz
6 Vrms in ISM and
amateur radio
bands between
0,15 MHz and 80
MHz
80 % AM at 1 kHz
6Vrms
Portable and mobile RF
communications equipment
should be used no closer to
any part of this device,
including cables, than there
commended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
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Apex Digital Sedens 500 Manuale utente

Tipo
Manuale utente