Steiss UTS User Manual

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Page 1

Universal Therapy System (UTS)

USER MANUAL

Page 2

Section Content Page Number

1. The Purpose of this Manual 3

2. Important Safeguards 3

3. Product Description 4

Intended Use 4

General Safety 4

4. Quick Start Guide: 5

Arrival of Product 5

Contents

Preparation of Area 5

5. Installation Guide 6

Initial Set Up 6/7

6. Hand Set / System Control 8

7. Maintenance & Troubleshooting 9

8. Cleaning & Disinfection Protocol 10

9. Specication 11

10. EMCRelatedNotications 12/13/14/15/16

11. Storage & Care 17

12. Waste Disposal 18

13. Symbols Used 18

14. Expected Service Life 18

15. Warranty 19

16. Legal Disclaimer 19

17. Service 20

18. Service Notes 21

19. Service Log 22

Page 3

1.The Purpose of this Manual

This operation manual is mainly focused on the set-up, cleaning and routine maintenance of the Steiss™ Universal Therapy System (UTS). We recommend that you keep this manual to hand to answer any

questions that may arise that are related to the system.

2. Important Safeguards

When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following:

INDOOR USE ONLY

DANGER - READ ALL INSTRUCTIONS BEFORE USING THE APPLIANCE

To reduce the risk of electrocution:

1. Always unplug this product immediately after use.

2. Do not use while bathing.

3. Do not place or store 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, unless following specic manufacturers guidelines.

5. Do not reach for a product that has fallen into water. Unplug immediately.

WARNING: To reduce the risk of burns, electrocution, re or injury to persons:

1. This product should never be left unattended when plugged into a power outlet.

2. Close supervision is necessary when this product is used by, on, or near children or physically challenged individuals.

3. Only use this product for its intended purpose, as described in this manual.

4. Never use attachments with this system that have not been recommended or approved by the manufacturer.

5. Never connect this product to a power supply or operate it if:

A. The system shows any signs of having a damaged cord or plug.

B. It does not appear to work properly or makes any abnormal noise.

C. The products has been dropped or damaged, or dropped into water.

Should any of the above be relevant, return the product to a service center for examination and repair.

6. Keep the electrical cord away from heated surfaces, open ames, liquids and sharp objects.

7. Never drop or insert any object into any openings.

8. Do not use outdoors, operate where aerosol (spray) products are being used, or where oxygen is being administered.

9. ALWAYS disconnect from power supply before opening up the mattress.

10. The product has no user serviceable parts except for fuse replacement.

11. If pain, irritation, numbness, swelling, or redness occurs discontinue use and contact a healthcare professional.

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3. Product Description

Intended Use

The Steiss™ Universal Therapy System (UTS) is an alternating air replacement system designed to prevent and treat pressure ulcers. The Steiss™ Universal Therapy System (UTS) works on the principle of actively

encouraging tissue blood ow by gently increasing and decreasing pressure within the support surface over

a 10-minute cycle. This results in the reduction of surface pressures helping to prevent tissue breakdown and encourage healing.

For added durability, and longer working life, the Steiss™ Universal Therapy System (UTS) has been constructed using high strength components and premium grade materials. The mattress features a heavy-duty base layer and a 100% waterproof, multi-stretch vapor permeable PU cover to reduce risks of friction and shear.

General Safety

It is important to read the information in this user manual before you use your Steiss™ Universal Therapy System (UTS).

Please follow the guidelines below for your added safety and maintaining system performance.

● Maximum patient weight is 175kg and minimum user weight is 30 kg.

● Avoid exposing pump to liquids.

● When cleaning do not use Phenol based substances.

● This Steiss™ Universal Therapy System (UTS) must be used on top of a bed frame.

● Never block the air opening or insert any object into them.

It is at all times the Carers responsibility to ensure that there is adequate/ legal clearance from the top of this mattress to the top of any side rails tted to the bed.

IntendedUserProle

● Education/Knowledge: 8th grade+

● Must be able to read and understand ‘Westernized Arabic’ numerals when written in Arial font

● Have a basic understanding of hygiene standards

● Have relevant experience in a nursing environment

● Permissible impairments: Except for contraindications

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4. Quick Start Guide

Arrival of Product

BOX 1:

Air-Alternating mattress, pump and manual

Preparation of Area

1. Place the Steiss™ Universal Therapy System (UTS) directly on top of the bed frame and ensure that the CPR is at the head of the bed. Secure the mattress using the straps at the base.

CAUTION: When securing the mattress to the bed, please ensure that you are securing

onto the movable parts of the bed and NOT the actual bed frame, as this will obstruct the mechanical movement and could cause damage to both mattress and bed. The warranty for both the mattress and the bed may well be invalidated if damage is caused by this means.

NOTE:Whenthemattressisopenedforthersttime,pleasewritetoday’sdate (with a non-Phenol based pen) in the top white box on the PU cover and add in the ‘same

date’forthefollowingthreeyearsinthebottomwhitebox.Thiswillremindthecareteam

when the annual service is due.

2. Hang the hand set on to the bed rail or mattress platform and plug the power cord into the mains

outlet. Ensure that electrical cables are safe and tidy and are not caught in the bed frame and free from obstruction. The power LED will be at standby mode with amber light illuminating.

CAUTION: it is important to routinely inspect power cable to ensure it is not obstructing or

causing a tripping hazard. Check the power cable is not under strain or damaged.

3. Ensure that the CPR valve is set to ‘CLOSE’ position.

Turn the dial

to ‘CLOSE’ position to inate

the air mattress.

4. Turn the power on from the handset (Green LED illuminated)

5. When the Steiss™ Universal Therapy System (UTS) is turned on, the pump will start to inate the mattress

for around 30 minutes in alternating mode. During this ination period the ‘AF’ (Auto Firm) will be displayed

on the LED window to indicate the mattress is not ready to use.

CAUTION: It is important to ensure that no person/ object is lying/ sitting on the mattress whenitisbeinginated.

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5. Installation Guide

Initial Set Up

The UTS mattress denes a new product category within the pressure care mattress range spectrum. A step up from traditional hybrid system. Allows the user to adopt and customize the system to suit a wider range of care requirements.

1. STATIC COMFORT MODE Mattress is fully inated and held in static mode with top surface foam in position underneath top PU outer cover (mattress is plugged in and switched on in standby mode)

2. DYNAMIC COMFORT MODE Mattress is fully inated and operated in auto dynamic mode with top surface foam in position underneath. Top PU outer cover.

3. DYNAMIC MODE (AUTO)

Mattress is fully inated and operated in auto mode with patient in direct contact with alternating cell surface for

maximum reactive therapy. Foam top surface is stored inside the pocket beneath the dynamic cells.

4. DYNAMIC MODE (MANUAL)

Mattress is fully inated and operated in manual dynamic mode with patient in direct contact with Alternating cell surface (underneath top PU outer cover). Surface pressure is adjusted manually via handset to maximize patient comfort (constant low-pressure therapy – CLP). This is particularly benecial to hyper sensitive patients where the benets of the reactive therapy are matched to comfort.

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5. Installation Guide

When the Steiss™ Universal Therapy System (UTS) is turned on, the pump will start to inate the mattress for

around 30 minutes in alternating mode. During this ination period the ‘AF’ (Auto Firm) will be displayed on LED

window to indicate the mattress is not ready to use.

When ‘MAX’ LED goes off, a bed sheet can be added (NOT tucked under and left to hang free) and a patient can be placed on the mattress surface and positioned. The audible alarm is disabled during the ination period and will resume its function when the ‘AF’ LED goes off.

Once the mattress is properly inated, system will go to alternating mode. Press ‘auto’ button to enable auto

detection feature and the system will automatically set to an optimum pressure by patient weight. The Steiss™ Universal Therapy System (UTS) also allows the care giver a exibility to disable ‘auto’ feature

and switch to manual adjustment, by repeatedly pressing ‘LEVEL’ button to accommodate an individual’s comfort if needed. Default manual setting will be the level detected during ‘Auto’ mode, or at level 2 if detection is incomplete.

Please note: ‘AUTO FIRM’ and ‘STATIC’ mode is designed to return to ‘ALTERNATE’ mode after

30 minutes of activation.

This Mattress features a cardio Pulmonary Resuscitation (CPR) valve at patient’s right side at the head end.

In the event of cardiac arrest, turn the CPR valves to the ‘OPEN’ position for fast deation of the air mattress

Turn the dial to OPEN position to release air.

IMPORTANT: please ensure that the care staff are trained and familiarized with the mattress and

this function.

CAUTION: During power failure/ outage, the Steiss™ Universal Therapy System (UTS) will stop functioning and the PF (power failure) alarm codes will be displayed on LED window with audio alarm. The pump will return to its normal operations when power is resumed.

The design of the system does allow the safe support of a patient even in the case of a power failure and loss of air from within the mattress.

In the event of product failure, unless the mattress has been ‘set’ to operate as a standard, non-powered system or altered to be a ‘step-down’ option, return the product to a service center

for examination and repair.

Attention: If the airow output varies, becomes unstable or stops erratically, it could be caused from

EMC disturbance or an unstable power socket. Be sure to use the device with a stable power supply or in connection with UPS and repress the power ON button to activate the air replacement system.

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MODE -

to select Auto Firm (AF), Alternating (AL) and Static (ST), Therapy Modes by repeatedly pressing “Mode” button – the pump is set to alternating mode by default with “AL” display on LED window. UTS is programmed to default back to alternating mode after 30 minutes of usage.

LEVEL -

allows for manual adjustment, by repeatedly pressing “LEVEL”

button to accommodate an

individual’s comfort if needed.

Default manual setting will be the level detected during “Auto” mode, or at Level 2 if Auto detection is

incomplete. Display of “LEVEL”

will automatically go back to “MODE” when not in operation for 10 seconds.

ALARM CODES DISPLAY - When LP (Low Pressure) occurs, system will alert user with a visual alarm displayed in LED display window, and audible alarm will be triggered 5 minutes after visual alarm.

PF (Power Failure) will be displayed in LED window with an audio alarm to indicate a power outage situation.

ALARM CODE

MODE

6. Hand-Set / System Control

POWER - Power On (Green LED), Standby (Amber LED)

AUTO Weight Detection function, is enabled by press “Auto” button

and will self-adjust the comfort level by patient’s weight. NOTE:

The “AUTO” detection mode will be disabled when comfort level is

manually adjusted. Press “AUTO”

again to re-activate the automatic weight detection when needed.

LOCK/UNLOCK/ ALARM MUTE BUTTON -

allows user to manually lock

(3 seconds) / unlock (3 Seconds)

the control panel to safeguard against any unwanted attempt to alter the settings.

Control panel will auto lock when system is not in operation for 5 minutes.

Alarm Mute: Press to mute the

audio alarm. The alarm will re-activate after 20 minutes if the problem is not resolved.

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7. Maintenance & Troubleshooting

No daily maintenance is required. It is intended this equipment should only be serviced by qualied and authorised technical personnel.

Fault/Problem Description Troubleshooting Solution

Check Steiss™ Universal Therapy System (UTS) is connected to the

mains power supply.

Check the power is switched on.

No indication that the pump is on.

Low Pressure in mattress.

Mattress not inating.

Check for loose connection on plug and main power is switched on.

Check for blown fuses in plug. Replace fuse if blown.

Check if mains socket is faulty. Try another socket

Check Steiss™ Universal Therapy System (UTS) is connected to the mains power supply.

Check Steiss™ Universal Therapy System (UTS) air connections are

tted securely. Ensure airow is

coming out from pump.

Check CPR is set to CLOSE position and is not leaking.

Check the connector tubes for kinks, obstructions or damage.

Secure plug connection and turn on power from main.

Ensure the main power is turned on and Steiss™ Universal Therapy System (UTS) is plugged into mains.

Ensure connectors are securely fastened and reconnect pump air hoses if loose. Ensure pump is turned on.

Ensure CPR valve is set to CLOSE position. Replace CPR valve if an air leak is found.

Untwist any kinks, or move any obstructions.

Pump controls lock up or ‘freeze’.

If problem is still not resolved, please contact your Steiss™ sales representative for advice.

CAUTION: Please ensure the Air Blower is used with stable power supply or in connection with UPS.

Check air intake from lter is not blocked by linen/dust.

Turn off and unplug Steiss™ Universal Therapy System (UTS).

Replace with new lter.

Rest Steiss™ Universal Therapy System (UTS) for a few seconds and

plug the back in to main and turn on the pump.

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8. Cleaning & Disinfection Protocol

It is very important to have a strict cross infection, cleaning and disinfection policy in line with current Hospital/Nursing Home infection control guidelines.

1. Remove the bedding.

2. If necessary, inate the mattress.

3. Ensure that the power unit is off.

4. Unplug the power cord from the wall outlet.

5. Ensure that the underside of the mattress is clear of all sharp objects.

6. Perform one of the following:

• If blood is present, decontaminate the whole mattress product in line with current hospital or Nursing Home Guidelines.

• If blood is not present, remove any soil from the cover with paper towels.

NOTE: If grossly soiled, the cover should be removed, cleaned and decontaminated.

7. Using a clean sponge or paper towel, wipe down the cover surface and cells with a diluted detergent solution or recommended cleaner disinfectant or other germicidal detergent solution.

8. Cleaning and disinfection may be carried out on the cover with hand hot water and a neutral detergent or with a sodium hypochlorite solution (0.1% or 1000 parts per million available chlorine).

9. Alternatively remove the cover and launder, 95o C (203o F), using normal detergents.

It is essential that articles be thoroughly dried after all cleaning procedures and before storage.

10. Perform the following steps to clean the power unit and hose ttings:

Open the system and expose the pump which is housed in the corner at the foot end of the mattress.

- Wipe all controls, chassis and hose ttings with a damp cloth and a mild detergent.

- Using a nylon brush, gently clean all crevices as they can harbor microorganisms.

- Air dry all treated surfaces.

WARNING:

● Switch off the electrical supply to the pump and disconnect the

power cable from the mains before cleaning and inspection.

● Protective clothing should be worn when performing cleaning procedures.

● Do not use Phenol based cleaning solutions.

All equipment should be inspected. Any item that is visibly soiled with the patient’s blood or other body uids should be properly cleaned or removed. It is

recommended that the system is clean regularly and after each patient use.

In many cases it will be only be necessary to remove the mattress cover for cleaning. If there is obvious soiling a complete cleaning or decontamination

will be required.

1010

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9. Specication

Model name: Steiss™ Universal Therapy System (UTS)

Size in CM (L x W x H):

Weight of system: 15kg

Cycle time (min): 10 min

Max user weight: 175kg

Minimum user weight: 30kg

Min/Max pressure: 20 ~ 60 mmHg +/- 6mmHg

Max ow rate:

Rated voltage: AC100 – 240V / 50Hz-60Hz

Max current: 0.2-0.1A

Fuse rating: T1AH 250V

Protection type: Class II Type BF

200 x 90 x 18 cm

≥ 6 L/min

Ingress of water protection: IP22

Mode of operation: Continuous

Environment (Temperature):

Environment (Humididty):

Operation atmospheric pressure range:

Operation altitude:

Test standard: IEC60601-1, IEC60601-1-2 and IEC60601-1-11

Safety standard: CE

Mattress material:

Packaging in CM (L x W x H): 67 x 27 x 98 CM

Accessories:

Operation: 15ºC to 35ºC (59ºF to 95ºF) Storage: 5ºC to 60ºC (41ºF to 140ºF)

Operation: 30% to 75% non-condensing Storage: 30% to 90% non-condensing

700 hPa to 1060 hPa

-1017 feet to 9,843 feet (-310 metres to 3000 metres)

Top Cover: Two way stretch, PU laminated Nylon Base Cover: PVC laminated Polyester

Item Model Material

Handset HS-NBE ABS

1111

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10. EMC - Related Notication

Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to the EMC (Electro Magnetic Compatibility) information provided. Careful consideration of this information is essential when stacking or collocating equipment and when routing cables and accessories.

Warning: RF mobile communications equipment can effect medical electrical equipment.

Recommended separation distances between portable and mobile RF communications equipment and the Steiss™ Universal Therapy System (UTS)

The Steiss™ Universal Therapy System (UTS) is intended for use in an electromagnetic environment (for home healthcare) in which radiated RF disturbances are controlled. The customer or the user of the Steiss™ Universal Therapy System (UTS) can help prevent electromagnetic interference by maintaining a minimum distance between

portable and mobile RF communications equipment (transmitters) and the Steiss™ Universal Therapy System (UTS) as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

Rated Maximum output

power of transmitter

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

150 kHZ to 80 MHz

d = 1,2 √P

(metres)

80 MHz to 800 MHz

d = 1,2 √P

800 MHz to 2.5 GHz

d = 2,3 √P

1212

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reection from structures, objects, and people.

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10. EMC - Related Notication

Manufacturer’sdeclaration–electromagneticemissions

The Steiss™ Universal Therapy System (UTS) is intended for use in the electromagnetic environment (for home

healthcare and professional healthcare) specied below. The customer or the user of the Steiss™ Universal Therapy System (UTS) should ensure that it is used in such an environment.

Emissions Test Compliance Electromagneticenvironment–guidance

RF Emissions

Group 1

CISPR 11

RF Emissions

Class B

CISPR 11

Harmonic Emissions

Class A

IEC 61000-3-2

Voltage Fluctuations

icker emissions

IEC 61000-3-3

During test, the wired control box signal display ashes but it could return to normal status. The device’s essential performance isn’t affected, therefore there is no concern relating to

basic safety. Please refer to the Risk Management Report for details.

Compliance

The Steiss™ Universal Therapy System (UTS) 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 Steiss™ Universal Therapy System (UTS) 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.

1313

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10. EMC - Related Notication

Manufacturer’sdeclaration–electromagneticimmunity

Test specications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment. The M31 Handset (HS-BE), M31 Handset (HS-NBE) is intended for use in the electromagnetic environment (for home healthcare) specied

below. The customer or the user of the M31 Handset (HS-BE), M31 Handset (HS-NBE) should assure that it is used in such an environment.

Test

frequency

(MHz)

385 380-390 TETRA 400

450 430-470

710

745

780

810

870

930

1720

1845

1970

2450 2400-2570

5240

5500

5785

Band a)

(MHz) Service

GMRS 460,

FRS 460

704-787

800-960

1700-1990

5100-5800

LTE Band

800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

GSM 1800;

CDMA 1900;

GSM 1900;

LTE Band

4, 25; UMTS

Bluetooth,

WLAN,

802.11 b/g/n, RFID 2450,

LTE Band 7

13, 17

DECT;

WLAN

802.11

GSM

1, 3,

a/n

Modulation

modulation b)

Pulse

18 Hz

FM c)

±5 kHz

deviation

1 kHz sine

Pulse

217 Hz

Pulse

18 Hz

Pulse

217 Hz

Pulse

217 Hz

Pulse

217 Hz

Maximum

power

(W)

1,8 0,3 27 27

2 0,3 28 28

0,2 0,3 9 9

2 0,3 28 28

0,2 0,3 9 9

Distance

(m)

IMMUNITY

TEST LEVEL

(V/m)

Compliance

LEVEL

(V/m)

(for home

healthcare

NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent

actual modulation, it would be worst case

1414

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10. EMC - Related Notication

Manufacturer’sdeclaration–electromagneticimmunity

The Steiss™ Universal Therapy System (UTS) is intended for use in the electromagnetic environment (for home healthcare)

specied below. The customer or the user of the Steiss™ Universal Therapy System (UTS) should assure that is used in such and environment.

Immunity test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

IEC 60601

test level

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

10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

Compliance

level

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

10 V/m 80 MHz – 2,7 GHz

80 % AM at 1

kHz

Electromagnectic

environment - guidance (home healthcare and

professional healthcare environment).

Portable and mobile RF communications

equipment should be used no closer to any

part of the Steiss™ Universal Therapy System

(UTS)

, including cables, than the recommended

separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1,2 √P

d = 1,2 √P 80 MHz to 800 MHz

d = 1,2 √P 800 MHz to 2,5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from xed RF transmitters, as

determined by an electromagnetic site survey, should be less than the compliance level in each

frequency range.

Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reection from structures, objects, and people.

Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the M31 Handset (HS-BE), M31 Handset (HS-NBE) is used exceeds the applicable RF compliance level above, the M31 Handset (HS-BE), M31 Handset (HS-NBE) should be

observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,

such as re-orienting or relocating the M31 Handset (HS-BE), M31 Handset (HS-NBE). Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

1515

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10. EMC - Related Notication

Manufacturer’sdeclaration–electromagneticimmunity

The Steiss™ Universal Therapy System (UTS) is intended for use in the electromagnetic environment specied below. The customer or the user of the Steiss™ Universal Therapy System (UTS) should assure that it is used in such an environment.

Immunity test

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast

transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage Dips, short in

terruptions and voltage variations on power supply input lines IEC 61000-4-11

IEC 60601

test level

Contact:±8 kV

Air±2 kV,±4 kV,±8 kV,±15 kV

±2 kV for power

supply lines

±1 kV for input/output

lines

+ 0.5kV, +1kV line(s) to

line(s)

+ 0.5kV, +1kV,+ 2kV

line(s) to earth

Voltage dips:

0 % UT; 0,5 cycle 0 % UT; 1 cycle

70 % UT; 25/30 cycles

Voltage interruptions: 0 % UT; 250/300 cycle

Compliance level

Contact:±8 kV

Air±2 kV,±4 kV,±8 kV,±15 kV

±2 kV for power

supply lines

Not applicable

+ 0.5kV, +1kV line(s) to

line(s)

Not applicable

Voltage dips:

0 % UT; 0,5 cycle 0 % UT; 1 cycle

70 % UT; 25/30 cycles

Voltage interruptions: 0 % UT; 250/300 cycle

Electromagnectic

environment - guidance (for home

healthcare and professional healthcare)

Floors should be wood, concrete, or ceramic tile.

If oors 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.

Mains power quality should be that

of a typical home healthcare and professional healthcare environment.

Mains power quality should be that

of a typical home healthcare and professional healthcare environment. If the user of the Steiss™ Universal

Therapy System (UTS) requires

continued operation during power mains interruptions, it is recommended that the Steiss™ Universal Therapy System (UTS) be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic eld

IEC 61000-4-8

NOTE: UT is the AC mains voltage prior to application of the test level.

30 A/m 50 Hz or 60 Hz

30 A/m 50 Hz

1616

The Steiss™ Universal Therapy System (UTS) power frequency

magnetic elds should be at levels

characteristic of a typical location in a typical home healthcare and professional healthcare environment.

Page 17

11. Storage & Care

1. Ensure the system is clean and free from infection.

2. Check the power cord and plug for abrasions or excessive wear. Note: Please follow the recommended guidelines when storing. It is recommended the following guidelines are used whenever this system is being stored or transported to another location: Temperature limitations: 5°C (41°F) ~ 60°C (140°F) / Relative Humidity: 30% to 90%

3. Carefully place the hand set and power connection lead onto the mattress in readiness for safe storage within rolled mattress.

4. Disconnect the CPR valve to allow the mattress to deate quickly

5. Starting at the foot end (motor body end) of the mattress, roll the unit up and use the base mount straps to secure it.

6. Place the Mattress in the Steiss™ Carry bag or Suitable large plastic bag for storage.

Page 18

12. Waste Disposal

This product has been supplied by an environmentally aware manufacturer that

complies with the WEEE (Waste Electrical & Electronic Equipment) directive.

This product may contain substances which could be harmful to the environment if

disposed of in places (landlls) that are not appropriate according to the legislation.

Please be environmentally responsible and recycle this product via your recycling facility at the end of its product life.

13. Symbols Used

Type BF

Protection Against

Electronic Shock

Class II Equipment

Operating Instructions Waste Disposal

Caution, consult

accompanying documents

Alternating Current

Manufacturer Interference

14. Expected Service Life

The Steiss™ Universal Therapy System (UTS) pump has an expected minimum service life of two years.

To maintain the condition of the pump, do ensure that the pump is serviced according to the schedule

recommended by Steiss™.

Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Steiss™ Universal Therapy System (UTS).

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15. Warranty

• Steiss™ guarantees this equipment to be free from defects in material and workmanship for up to 36

months from the date of delivery to your unit.

• At the manufacturer’s discretion, we agree to service, repair or replace any equipment or part found to be

defective, at no charge.

• This warranty excludes equipment that has been damaged during shipping, or through tampering, improper maintenance, carelessness, an accident, negligence, or misuse, as well as equipment that has been altered, repaired or dismantled other than with the manufacturer’s written authorisation and by a properly qualied technicians following approved procedures.

• In no event shall Steiss™ be liable for any direct, indirect or consequential damage or loss resulting from the use of this equipment.

• The warranty is non-transferable.

16. Legal Disclaimer

Terms such as ‘Medium Risk’, ‘High Risk’ and ‘Very High Risk’ are descriptions of an individual’s risk level

of developing a pressure sore. (Descriptive Risk Levels). These risk levels are assessed by nurses and as

there may be some variability between nurse measurements/observations, descriptive risk levels should

only be used as a guideline.

Steiss™ uses these Descriptive Risk Levels based on existing market research and internal study to show the suitability and effectiveness of the pressure care systems provided. Internal and external research is and will always be ongoing. These Descriptive Risk Levels should not be taken as prescriptive criteria.

Steiss™ mattresses/cushions should be seen as an aid to care and DO NOT replace the need for good

nursing care and intervention. All Steiss™ products must be used as part of an individualised care plan

which includes proper nursing practices i.e. turning/repositioning, and regular patient skin assessments.

Pressure-relieving equipment alone will not prevent pressure ulcers. Pressure ulcers are multi factorial and both external and internal factors may cause them to develop. It is up to the professional judgement

of a nurse to assess the risk and develop a care plan which prescribes suitable pressure reducing

equipment and appropriate nursing care. Some pressure sores are inevitable due to falls and longer

periods of immobility. Some sores can developing below the surface of the skin. It may not be visible to the naked eye and may therefore not become obvious for hours or days after a fall or longer periods of

immobility or injury. For this reason Steiss™ cannot guarantee that the use of the equipment alone will

prevent pressure ulcer formation.

The care giver, operating in accordance with the guide for best clinical practice, will be advising suitable

treatment and just using this mattress manual as a guide only.

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RECORD PRODUCT DETAILS

Serial Number

Model Number

Ward or Care Establishment

Deployment date / rst opening date

SERVICE EQUIPMENT

Flow gauge

Manometer

Details of mattress and pump audit proceedure

17. Service

SERVICE GUIDELINES

General Condition - check these areas: Details:

PU cover, cover welds, screen print and base substrate Look for signs of damage

Mains lead Signs of wear and tear

Pump mechanism Check that they are working properly

Check labelling, decal membrane, buttons and handset

CPR Mechanism Check it is in good working order

Internal Mattress condition - check these areas:

All T and L connectors Check for wear, strain or damage

Internal assembly tubing Check for wear, strain or damage

Connecting tube Check for wear, strain or damage

Cells condition, including welds Check for wear, strain or damage

Pump Function - Functional calibration

Functional calibration check of pump/mattress system

Ensure Dynamic mode and static mode are working in the pressure range

Ensure power failure alarm and high and low pressure alarms are

working if tted

Check cell therapeutic pressure

Check for excessive wear, uid penetration

and that there is a good button functionality

This is a physical test changing modes and checking cells.

Turn power off and disconnect hose separately

Use Manometer (Low mm/hg- high mm/Hg)

on alternation

- Report and replace and defective items

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18. Service Notes

NOTE: This is only a physical check of the mattress / pump system and by no way meant to replace anything that is recommended by the MHRA EPUAP or similar professional body.

We recommend you check your relevant Healthcare Body website for any further information that may need to be incorporated into your checks. These may be some country specic legislation re audit procedures for this kind of equipment. You may need to change and adapt this procedure to suit your

particular market.

SERVICE NOTES

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