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Alternating Air-Pressure Mattress Overlay System

MANUAL STEISSTM 340

Grade* This ‘Grade’ is a guide only. Each individual must be assessed by a tissue viability specialist, the correct product chosen and set to operate according to the patient’s needs. Regular repositioning schedules need to be in place as this product does not replace good nursing care.

Alternating Air-PressureMattress System

USER MANUAL

SERIES3

AX340 Mattress Overlay Grade* 2/3

AX3402 Mattress Replacement Grade* 3

Contents Page

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1. The Purpose of this Manual


2. Important Safeguards

3. Quick Start-up guideArrival of Product Preparation of area Inflation of mattress Mattress CPR check Mattress comfort check Hand check

4. Emergency Air Release – CPR valve functionAlarm Function Deactivation of Alarm

5. Product DescriptionIntended Use Features of Master Control Unit/pump Features of Mattress

6. Instructions for Proper use

7. Maintenance Troubleshooting

8. Cleaning & Disinfection Protocol Cleaning ofMattress Cover Cleaning of Mattress Cells Cleaning of Master Control Unit Cleaning of Air Filter

9. How to Replace Air Filter

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Storage & Care

Specification / Technical Data

EMC (Electro Magnetic Compatibility) Guide

Waste Disposal

Symbols Used

Expected Service Life

Warranty

Legal Disclaimer

Service Guidelines & Equipment Notes Steiss Service Record

This operation manual is mainly focused on the setup, cleaning and routine maintenance of the Steiss 3 Series Alternating Air-Pressure Mattress System. The Steiss 3 Series is an alternating air-pressure mattress replacement system designed to prevent and treat pressure ulcers up to grade III. We recommend you keeping this manual handy to answer most of the questions related to the system. NOTE: This manual is just a guide and we advise all Nurses & Cares to take responsibility for the care of their mattress.

patients, including the responsibiltiy for questioning any matters in the manual, should they be in anydoubt.


Contents Page



3. Quick Start-up guideArrival of Product Preparation of area Inflation of mattress Mattress CPR check Mattress comfort check Hand check

4. Emergency Air Release – CPR valve functionAlarm Function Deactivation of Alarm

5. Product DescriptionIntended Use Features of Master Control Unit/pump Features of Mattress

6. Instructions for Proper use

7. Maintenance Troubleshooting

8. Cleaning & Disinfection Protocol Cleaning ofMattress Cover Cleaning of Mattress Cells Cleaning of Master Control Unit Cleaning of Air Filter

9. How to Replace Air Filter

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page 2

page 3 page 3 page 4 page 5 page 5 page 5

page 6 page 6 page 6


page 8

page 9

page 10-11 page 10 page 10 page 11 page 11

page 11

page 12

page 13

page 14-17

page 18

page 18

page 18

page 19

page 19


10.

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12.

13.

14.

15.

16.

17.

18.

Storage & Care

Specification / Technical Data

EMC (Electro Magnetic Compatibility) Guide

Waste Disposal

Symbols Used

Expected Service Life

Warranty

Legal Disclaimer

Service Guidelines & Equipment Notes Steiss Service Record

This operation manual is mainly focused on the setup, cleaning and routine maintenance of the Steiss 3 Series Alternating Air-Pressure Mattress System. The Steiss 3 Series is an alternating air-pressure mattress replacement system designed to prevent and treat pressure ulcers up to grade III. We recommend you keeping this manual handy to answer most of the questions related to the system. NOTE: This manual is just a guide and we advise all Nurses & Cares to take responsibility for the care of their mattress.

patients, including the responsibiltiy for questioning any matters in the manual, should they be in anydoubt.


Contents Page

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Never block the air openings or insert any object into them.

Never place mattress on a couch or sofa where the air openings could be blocked. Do not spray

any aerosols onto the mattress.

Note cleaning/washing instructions later in manual.

This device is not registered as AP/APG protected.

Do contact your service centre if this product is not working properly.

Use only manufacturer-approved parts when maintaining or repairing the Steiss 3 Series.

Use only manufacturer-approved accessories with this device.

All parts and accessories supplied are specially designed for use with the Steiss 3 Master

Control Unit.

Use of other parts and accessories in conjunction with this device is not recommended.

The control unit can only be repaired by an authorised technician.

Re-positioning of the patient is always recommended when using an alternating pressure air mattress.

It is advisable to monitor product when used by, on or near children and physically/mentally challenged individuals

If any pain, redness, irritation, numbness or swelling occurs while using cushion, please inform healthcare professional for them to assess and evaluate the situation.

Should the carer decide to insert extra foam or place this mattress on top of another mattress, it is at all times the carer’s responsibility to ensure that there is adequate/legal clearance from top of this mattress to the top of the side rails. Do regularly check, by hand that the mattress is inflated as expected

In the event of an extended power failure, it is advisable to disconnect the air hose from the pump and attach the transport clip.

Do remember to reconnect the mattress to the pump once the power has been re-established.•

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PLEASE READ ALL INSTRUCTIONS BEFORE USING THIS ELECTRICAL APPLIANCE

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Warning & Cautions

Only connect the Steiss 3 pump to a Steiss M40 mattress. Only connect the master control unit of the Steiss M40 mattress to a 220~240V Power source

Place power cable and pump away from head end to reduce risk of strangulation or entanglement with any cord, cable or pipe.

Keep the tubes free of kinks.

Disconnect the control unit power plug before moving the bed.

Do not unplug the control unit by pulling the cord.

Only use the Steiss 3 Series products indoors.

Only use this product if it has an un-damaged cord or plug.

Keep the cord away from heated surfaces.

Do not use this product, if it has been dropped or damaged, or it has been submerged into water. (Do return the product to a service centre to be examined and/or repaired.

Do not expose the control unit to humidity or direct moisture.

Operation Temp: 15 to 35 degree, 30% to 75% non-condensing

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3. Quick Start-up guide of Steiss 3 Series

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ARRIVAL OF PRODUCT

340 – 1 BOX containing: Air-Alternating mattress, pump, carry bag, manual3402 – 1 BOX containing: Foam underlay mattress

PREPARATION OF AREA

1. Unpack products

2. Place the Steiss 3 Series Alternating Pressure Mattress directly on top of the existing mattress and ensurethat the air hose is at the foot of the bed.

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 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.

3. Hang the Steiss 3 Series pump at the foot of the bed. Connect the push-fit hose connector from thefoot of the mattress to the air outlet of the pump.

4. Plug the pump power cable into the mains outlet. Ensure that electrical cables are safe and tidy, are notcaught in the bed frame and are free from obstruction. Turn the power on at the mains outlet.

CAUTION: It is important to routinely inspect power cables to ensure they are not obstructed or causing a tripping hazard. Check the power cable is not under strain or is damaged.

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3. Quick Start-up guide of Steiss 3 Series

2a. If model 3402 mattress replacement system is to be used:Place the foam underlay mattress into the pocket provided underneath the air cells and ABOVE the base sheet of the mattress. Be sure to refasten the pop fasteners along the side of mattress to keep the underlay mattress in position.

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INFLATION OF MATTRESS

1. Ensure that the Cardio Pulmonary Resuscitation (CPR) valve of side mattress is closed, ie that thedouble-hose has the double-plug properly pushed in.

CAUTION: It is important to ensure that no person/object is lying/sitting on the mattress when it is initially being

2. Turn on the control unit using the power switch located on the front of the pump. The mattress will then

3.

4. This control enables you to

5. The pump and mattress will then run continuously in ‘dynamic mode’.

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MATTRESS CPR VALVE CHECK After approximately 30-40 minutes the mattress should be fully inflated. If the mattress is NOT fully inflated, check that the CPR valve is in the closed position and that the pump is connected to the mattress correctly.

CAUTION: Please ensure that the PU mattress cover is fully zipped and CPR connection is closed properly after inspection.

CAUTION: During a power cut, pump will stop functioning and the ‘power LED’ indicator may be flashing as well as the power failure alarm may be triggered if equipped, these are normal. The pump will return to its normal operation when power is resumed.

MATTRESS COMFORT CHECK

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Re-check the comfort control setting on the pump unit.

If required, adjust the control setting to increase or decrease the required firmness of the mattress,using the patient’s weight as an initial guideline.

If the patient back rest moves greater than 30 degrees, increase the pressure in the mattress toaccommodate the extra load on the sacral cells.

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HAND CHECK

• To check whether the patient is being properly supported, slide one hand in between the air mattress andthe base to ensure that they are not ‘bottoming out’.

A gap of 2-4 cm /1-2 inches between the patient’s bottom and the bed base is an acceptable gap and is anindication of the correct pressure setting. If this is not the case, the pressure can be adjusted accordingly,using the comfort control dial.

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4. Emergency Air Release – CPR Valve Function

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This mattress features a Cardio Pulmonary Resuscitation (CPR) valve at the head-end side of the mattress.

In the event of a cardiac arrest, unplug the CPR valve and unplug the air hose from the pump. This will immediately deflate the mattress.

IMPORTANT: Please ensure that all care staff are trained and familiarised with the mattress and this specific function.

ALARM FUNCTION

4. Emergency Air Release - CPR Valve Function

The Steiss 3 Series Alternating Air-Pressure Mattress Overlay System is equipped with visual and audible alarms in the event of low pressure.

During the initial inflation period, the system is in low-pressure mode and the Low Pressure LED will illuminate. The audible alarm is set with a delay function to take into consideration the inflation time.

The alarm will activate automatically after 45 minutes if the unit does not inflate properly.

When the patient’s position changes, the mattress pressure will drop from the set pressure and the audible alarm will switch to a five-minute delay to avoid the alarm being activated.

DEACTIVATION OF AUDIBLE ALARM:

aS

lawit

rm.ch

the pump off., then back on, to deactivate the audible

5. Product Description

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INTENDED USE

The Steiss™ AXT350 Steiss 340 is an analogue high specification Alternating Air-Pressure Full Mattress Replacement System and is designed to prevent and treat pressure ulcers up to grade II.

The system uses the latest technology in alternating mattress therapy to provide accurate pressure settings for individual patients’ needs. The 18 cells of the mattress are arranged in a transverse manner to provide extra protection and comfort for the patient.

Through the use of alternating therapy Steiss™ AXT350 Steiss 340 system works on the principle of actively encouraging cycle. This results in the reduction of surface pressures helping to prevent tissue breakdown and encourage healing.

The eight thoracic/sacral cells feature therapeutic micro air loss holes maximizing the air circulation inside the body of the mattress, providing additional comfort.

For added durability, and longer working life, your Steiss™ AXT350 Steiss 340 mattress 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.

FEATURES OF MASTER CONTROL UNIT/PUMP •

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Very quiet system

1:2 alternation providing a very low interface pressure at 12 minute cycles

8 adjustable (dial) weight/comfort settings

Visual and audible alarms for low pressure and power failure

NOTE: The audio alarm will resume normal operation after the initial 45 minutes of inflation

Transport security device

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3 Series

3 Series

INTENDED USE







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Very quiet system






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INTENDED USE







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Very quiet system






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INTENDED USE







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Very quiet system






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3 Series is a

INTENDED USE







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Very quiet system






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6. Instructions for Proper Use

FEATURES - MATTRESS

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Mattress Overlay/Replacement System, suitable for home and care units (Overlay with foam pocket to base to extend t full replacement system

Grade II risk / management overlay – Grade III when used with foam underlay

1:2 alternation therapy for pressure care

18 supportive full depth cells for easier cleaning and servicing

3 static head cell section for greater patient comfort

Multi stretch, highly vapour-permeable PU top cover providing low shear, friction and moisture protection

Therapeutic Micro Air Loss feature assisting with moisture and temperature

External CPR design for fast emergency deflation

Premium quality all round zip with large waterfall cover for improved infection control

Modularised design allowing for easy cleaning and replacement of air cells

Strong base-mount straps holding the mattress when insitu and when in the rolled-form during storage Transport

Facility, with stopper ensuring mattress remains inflated even though disconnected from pump Recommended

minimum safe working capacity of 40kg/6.3 stone (30kg/4.1 stone)

Recommended maximum safe working capacity of 160Kg/25.2 stone

It is important to read this information before using the Steiss 3 Series Alternating Air-Pressure Mattress System. Please follow the guidelines below for your safety and to maintain the system’s performance.

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Minimum patient weight 40kg/6.3 stone (30kg/4.1 stone)

Maximum patient weight: 160kg / 25.2 stone.

Avoid exposing the pump to liquids.

Use a Steiss 3 pump with a Steiss M40 mattress only.

When cleaning do not use Phenol based substances. Steiss offer Multi-surface disinfection wipes which are ideal for cleaning both pump housing and mattress.


FEATURES - MATTRESS

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Mattress Overlay/Replacement System, suitable for home and care units (Overlay with foam pocket to base to extend t full replacement system

Grade II risk / management overlay – Grade III when used with foam underlay

1:2 alternation therapy for pressure care

18 supportive full depth cells for easier cleaning and servicing

3 static head cell section for greater patient comfort

Multi stretch, highly vapour-permeable PU top cover providing low shear, friction and moisture protection

Therapeutic Micro Air Loss feature assisting with moisture and temperature

External CPR design for fast emergency deflation

Premium quality all round zip with large waterfall cover for improved infection control

Modularised design allowing for easy cleaning and replacement of air cells

Strong base-mount straps holding the mattress when insitu and when in the rolled-form during storage Transport

Facility, with stopper ensuring mattress remains inflated even though disconnected from pump Recommended

minimum safe working capacity of 40kg/6.3 stone (30kg/4.1 stone)

Recommended maximum safe working capacity of 160Kg/25.2 stone

It is important to read this information before using the Steiss 3 Series Alternating Air-Pressure Mattress System. Please follow the guidelines below for your safety and to maintain the system’s performance.

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Minimum patient weight 40kg/6.3 stone (30kg/4.1 stone)

Maximum patient weight: 160kg / 25.2 stone.

Avoid exposing the pump to liquids.

Use a Steiss 3 pump with a Steiss M40 mattress only.

When cleaning do not use Phenol based substances. Steiss offer Multi-surface disinfection wipes which are ideal for cleaning both pump housing and mattress.


7. Maintenance & Troubleshooting

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No daily maintenance is required. technical personnel.

It is intended this equipment should only be serviced by qualified and authorised

If issue not resolved, please contact your Steiss Supplier.

Fault/Problem Description Troubleshooting Solution

No indication that the pump is on Check pump unit is connected to the mains power supply.

Check the pump is switched on.

Ensure mains plug is connected and on.

Check the pump is switched on.

Check mains plug fuse. Replace fuse if blown.

Check if mains socket is faulty. Try another socket. If still not working; consult the Steiss technician.

The pump is noisy. Make sure the pump is hanging freely Check there is nothing rubbing against the pump. Reposition. If still noisy; consult the Steiss technician

Low Pressure in mattress/mattress not inflating.

Check the pump unit is connected to the mains power supply.

Check the pump is switched on and fuse in plug is ok.

Check pump/mattress air connections are fitted securely. Ensure air is coming from pump.

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

Check CPR is connected correctly and is not leaking.

Reconnect CPR if not secure.

Check the connector tubes for kinks, obstructions or damage.

Untwist any kinks, or move any obstructions.

Check the setting on the comfort control pressure range dial.

Turn up dial to increase pressure, wait for pressure to stabilize (a few minutes before making another adjustment.

Remove filter on back of the pump to check if it is dirty.

Replace with new filter.

Pump controls ‘freeze’ Turn off and unplug the pump. Wait a few seconds, then plug the pump back in. Turn on the pump.

Low pressure light is constantly illuminated or mattress does not inflate when pump is operating.

Check for loose hose connections.

Check the CPR valve.

Check air cells for holes/tears (other than where part of the design)

Make sure connectors are secured.

Make sure CPR valve is closed.

Replace any damaged air cells. Consult a qualified service technician if the problem persists.

7. Maintenance & Troubleshooting

8. Cleaning & Disinfection Protocol of all parts

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CLEANING OF THE MA TTRESS COVER

The mattress should be cleaned on the bed weekly using a damp, soft cloth and mild detergent.

NOTE: Do not use a phenol-based cleaning solution as this may reduce the life of the mattress.

Steiss has developed a dedicated wipe to ease the process for their clients. If the top PU cover becomes dirty, unzip top cover from bottom section and wash. If the PU cover on the base-foam becomes dirty, unzip top cover from bottom section and wash. If the top cover or base cover becomes excessively soiled, put on protective wear and remove the covers from the air cells and tubing. Place the soiled covers in an appropriate plastic bag and consult your supplier for advice on specialist cleaning. Then replace with clean covers.

If the covers are minimally soiled, then these can be washed and thermally disinfected in a washing machine by following the procedures below:

Industrial Break wash Main wash Main wash Extraction Cold Rinse Extraction

Cold 60°C (140°F) 70°C (158°F)

10 minutes 6 minutes

10 minutes 2 minutes

5 minutes

Domestic Pre-wash Main wash Extraction Cold rinse Extraction

Cold 70°C (158°F) 10 minutes

2 minutes

5 minutes

Note: Tumble Drying or Tunnel Drying is not recommended.

CLEANING OF THE MA TTRESS CELLS

Mattress cells can be wiped down with a solution of sodium hypochlorite 1,000ppm or any other non-phenol- based germicidal cleaning solution.

Steiss have developed a dedicated wipe to ease the cleaning process for their clients. Please ask your mattress supplier for Multi-surface disinfection wipes.

8. Cleaning & Disinfection Protocol of all parts

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9. How to replace the Air Filter

CLEANING OF THE MASTER CONTROL UNIT

Remove the air filter cover to access the air filter. Pinch the centre of the air filter and pull it outward. Replace it with a new filter. Contact your supplier for a replacement.

9. How to replace the Air Filter

Caution: Always switch off the electrical supply to the pump and disconnect the power cord from the main supply before cleaning or inspection.

The pump unit should be cleaned weekly using a damp, soft cloth and a mild detergent. If the casing is especially dirty, the pump can be wiped down with a sodium hypochlorite solution to a dilution of 1,000ppm, or any EPA-approved hospital-grade disinfectant.

The pump casing is manufactured from ABS plastic - therefore:

NOTE: Do not use a phenol-based cleaning solution. Steiss has designed cleaning wipes called Multi-surface disinfection wipes. Please contact your supplier for this product.

CLEANING OF THE AIR FILTER

The air filter should be cleaned and checked every six months, at the very least. The air filter can be accessed via the air filter cover on the back of the unit. To remove the air filter; pinch the centre of the rectangle and pull it out. If the air filter opening is soiled, use a soft-bristle brush to remove dust and dried dirt.

10. Storage and Care of all parts

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MATTRESS

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Check the air manifold for kinks or breaks and replace it if necessary.

Disconnect the CPR valve and disconnect the air tubes from the control unit to allow the mattress to deflate quickly.

Starting at the head of the mattress, roll the unit up and use the base mount straps to secure it.

Place the mattress in carry bag provided for this purpose.

MASTER CONTROL UNIT/PUMP

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Check the power cord and plug for abrasions or excessive wear.

Plug in the control unit and verify air flow from the hose connection ports.

Place the control unit in a plastic bag to store it.

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: Relative Humidity:

5°C (41°F) ~ 60°C (140°F) 30% to 90%

10. Storage and Care of all parts

11. Specification/Technical Data

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Steiss 3 Master Control Unit / Pump

Model Name

Size L x W x H

Weight

Cycle Time

Min Operating pressure

Max Operating pressure

Max Flow Rate

Rated Voltage

Max Current

Fuse rating

Steiss 3 Master Control Unit 26 x 12 x 16.2cm

(10.23 x 4.72 x 6.38 inches)

2kg (4.41lbs)

12 minutes

20+/- 6mmHg

>60+/- 6mmHg

>5.5 L/min

AC 220-240V/50Hz

0.1Amp

T1AH 250V

Class II Type BF (Not AP/APG type)/Ingress of Water

ProtectionIP21 Continuous

Operation: 15°C to 35°C (59°F to 95°F)

Storage: 5°C to 60°C (41°F to 140°F)

Operation: 30% to 75% non-condensing

Storage: 30% to 90% non-condensing

IEC60601-1 & IEC60601-1-2 &IEC60601-1-11

CE

Mode of Operation

Environment (temperature)

Environment (humidity)

Test Standard:

Safety Standard:

Steiss M40 Mattress

Model Name

Size L x W x H

Weight

Cells Number

Cell Height

Cells Material

Cover Material

Base Material

Transport Facility

Maximum Weight Capacity

Steiss M40 Mattress

200.02 x 90.17 x 12.7cm (78.75” x 35.5” x 5”

4kg (8.82lbs

18 cells (2 types. 8 are vented and 10 are not vented

12.7cm PU coated nylon

PU laminated nylon cover w/ premium quality all-round zip

PVC laminated polyester

Yes & secure

160kg /25.2 stone

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12. EMC-Related Notifications

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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 medical electrical equipment.

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Recommended separation distances between portable and mobile RF communications equipment and the Steiss 3 Series

The Steiss 3 Series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Steiss 3 Series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Steiss 3 Series as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum output power of transmitter W

Separation distance according to frequency of transmitter (metres)

150 kHz to 80 MHz

d = 1,2

80 MHz to 800 MHz

d = 1,2

800 MHz to 2.5 GHz

d = 2,3 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 outputpower 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.

NOTE 2:

p pp

Caution: During EFT interference, pump LED indicator may be flashing, this is normal.

Caution: During power outage, pump will stop functioning, the POWER LED indicator may be flashing, and the power failure alarm may be triggered if equipped; this is normal. The pump will return to its normal operation when power is resumed.

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Guidance and manufacturer’s declaration – electromagnetic emissions

The Steiss 3 Series is intended for use in the electromagnetic environment specified below. The customer or the user of the Steiss 3 Series should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment – guidance

RF Emissions

CISPR 11 Group 1

The Steiss 3 Series 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.

RF Emissions

CISPR 11 Class B

The Steiss 3 Series 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.

Harmonic Emissions

IEC 61000-3-2 Class A

Voltage Fluctuations

IEC 61000-3-3

complies

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Guidance and manufacturer’s declaration – electromagnetic immunity

The Steiss 3 Series is intended for use in the electromagnetic environment specified below . The customer or the user of the Steiss 3 Series should ensure that it is used in such an environment.

Immunity test IEC 60601 test level

Compliance level Electromagnectic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete, or ceramic tile.

material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth

±1 kV line(s) to line(s)

±2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Interruptions and voltage variations on power supply lines

IEC 61000-4-11

*<5 % UT (>95 % dip in UT) for 0,5 cycle *40 % UT(60 % dip in UT)for 5 cycles*70 % UT(30 % dip in UT)for 25 cycles*<5 % UT(>95 % dip in UT)for 5 sec

<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

Power frequency (50/60 Hz)

IEC 61000-4-8

3 A/m 3 A/m should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

Mains power quality should be that of a typical commercial or hospital

the user of the Steiss

AX(R/T350 mains power

interruptions, it is powered by an

uninterruptible power supply, such as a generator or a battery.

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Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 test level

Compliance level

Electromagnectic environment - guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2,5 GHz

3 Vrms

3 V/m

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:

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with

Steiss 3 Series is used exceeds the applicable RF compliance level above, the Steiss 3 Series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product.

Portable and mobile RF communications equipment should be used no closer to any part of the Steiss AX(R/T) 350 Steiss 340, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance p

d = 1,2 p

d = 1,2 80 MHz to 800 MHz p

d = 2,3 800 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.

The Steiss 3 Series is intended for use in the electromagnetic environment specified below . The customer or the user of the Steiss 3 Series should ensure that it is used in such an environment.

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

3 Series

13. Waste Disposal

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14. Symbols Used

15. Expected Service Life

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

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

The Steiss 3 Series pump has an expected minimum service life of three 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 3 Series system.

18


Type BF Protection Against Electronic

Shock

Class II Equipment

Operating Instructions Waste Disposal

Caution, consult accompanying documents

Alternating Current

Manufacturer Interference

14. Symbols Used

13. Waste Disposal








18



Shock

Class II Equipment



Alternating Current


14. Symbols Used

13. Waste Disposal








18



Shock

Class II Equipment



Alternating Current


14. Symbols Used

13. Waste Disposal

The

16. Warranty

19

17. Legal Disclaimer

• Steiss guarantees this equipment to be free from defects in material and workmanship for up to 24 monthsfrom 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 bedefective, 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 hasbeen altered, repaired or dismantled other than with the manufacturer’s written authorisation and by aproperly qualified technicians following approved procedures.In no event shall Steiss be liable for any direct, indirect or consequential damage or loss resulting fromthe use of this equipment.The warranty is non-transferable.

•

•

•

•

A. Terms such as ‘Medium Risk’, ‘High Risk’ and ‘Very High Risk’ are descriptions of an individual’s risk level ofdeveloping a pressure sore. (Descriptive Risk Levels). These risk levels are assessed by nurses and as theremay be some variability between nurse measurements/observations, descriptive risk levels should only be usedas a guideline.

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

C. Steiss mattresses/cushions should be seen as an aid to care and DO NOT replace the need for goodnursing care and intervention. All Steiss products must be used as part of an individualised care plan whichincludes proper nursing practices i.e. turning/repositioning, and regular patient skin assessments.

D. Pressure-relieving equipment alone will not prevent pressure ulcers. Pressure ulcers are multi factorial andboth external and internal factors may cause them to develop. It is up to the professional judgement of a nurseto assess the risk and develop a care plan which prescribes suitable pressure reducing equipment andappropriate 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 maytherefore not become obvious for hours or days after a fall or longer periods of immobility or injury. For thisreason Steiss cannot guarantee that the use of the equipment alone will prevent pressure ulcer formation.

E. The care giver, operating in accordance with the guide for best clinical practice, will be advising suitabletreatment and just using this mattress manual as a guide only.


16. Warranty

• Steiss guarantees this equipment to be free from defects in material and workmanship for up to 24 monthsfrom 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 bedefective, 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 hasbeen altered, repaired or dismantled other than with the manufacturer’s written authorisation and by aproperly qualified technicians following approved procedures.In no event shall Steiss be liable for any direct, indirect or consequential damage or loss resulting fromthe use of this equipment.The warranty is non-transferable.

•

•

•

•

A. Terms such as ‘Medium Risk’, ‘High Risk’ and ‘Very High Risk’ are descriptions of an individual’s risk level ofdeveloping a pressure sore. (Descriptive Risk Levels). These risk levels are assessed by nurses and as theremay be some variability between nurse measurements/observations, descriptive risk levels should only be usedas a guideline.

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

C. Steiss mattresses/cushions should be seen as an aid to care and DO NOT replace the need for goodnursing care and intervention. All Steiss products must be used as part of an individualised care plan whichincludes proper nursing practices i.e. turning/repositioning, and regular patient skin assessments.

D. Pressure-relieving equipment alone will not prevent pressure ulcers. Pressure ulcers are multi factorial andboth external and internal factors may cause them to develop. It is up to the professional judgement of a nurseto assess the risk and develop a care plan which prescribes suitable pressure reducing equipment andappropriate 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 maytherefore not become obvious for hours or days after a fall or longer periods of immobility or injury. For thisreason Steiss cannot guarantee that the use of the equipment alone will prevent pressure ulcer formation.

E. The care giver, operating in accordance with the guide for best clinical practice, will be advising suitabletreatment and just using this mattress manual as a guide only.


16. Warranty

18. Service

20

- Report and replace and defective items

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 Case & Hanging Mechanism Check that they are working properly Check labelling, Decal membrane, buttons Check for excessive wear, fluid penetration

and that there is a good button functionality 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 This is a physical test changing modes and

checking cells. Ensure Dynamic mode and static mode are working in the pressure range

This is a physical test changing modes and checking cells.

Ensure power failure alarm and high and low pressure alarms are working if fitted

Turn power o. and disconnect hose separately

Check cell therapeutic pressure Use Manometer (Low mm/hg- high mm/Hg) on alternation

SERVICE EQUIPMENT Flow gauge

Manometer

Details of mattress and pump audit procedure

RECORD PRODUCT DETAILS Serial Number

Model Number

Ward or Care Establishment

Deployment date / first opening date

18. Service

21

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 specific 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

Service Record

22

First service due:

Steiss Authorised Service Centre:

8 All applicable service actions checked:

Open service actions completed:

Date:

Genuine Steiss** parts used:

First service due:




Date:


First service due:




Date:


First service due:




Date:


First service due:




Date:


First service due:




Date:


First service due:




Date:


First service due:




Date:


Service Record

Last Edited June 2018

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