Apex Digital Sedens 500 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 user’s 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 patient’s

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 it’s removed from storage, it may require 4.5

hours of charging with the original adapter to fully charge the battery.

CAUTION: It’s 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

p

ecified b

y

the manufacturer. Otherwise, de

g

radation of the

p

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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