Tidewave Turning Mattress Stops Pressure Ulcers

USER MANUAL

for the Tidewave™ Mattress

User manual for the Tidewave™ Mattress,
configurable medical device model TWTURNING.

This user manual containt important information about how to safely use the product and must be read before use.

Article number

• 70.160.001.EU-S
• 80.200.001.EU-S
• 80.200.001.EU-M
• 85.190.001.EU-S
• 85.190.001.EU-M
• 85.190.001.EU-H
• 85.200.001.EU-S
• 85.200.001.EU-M
• 85.200.001.EU-H
• 85.210.001.EU-S
• 85.210.001.EU-M
• 85.210.001.EU-H
• 90.190.001.EU-S
• 90.190.001.EU-M
• 90.190.001.EU-H
• 90.200.001.EU-S
• 90.200.001.EU-M
• 90.200.001.EU-H
• 90.210.001.EU-S
• 90.210.001.EU-M
• 90.210.001.EU-H
• 90.220.001.EU-S
• 90.220.001.EU-M
• 90.220.001.EU-H

This document was published 05.2024
Copyright © Tidewave Medical AS
This document is submitted in confidence and contains proprietary information which shall not be reproduced or transferred to others for the purpose of manufacture, tender or any other intentions without written permission of Tidewave Medical AS

Safety information

NOTE: The pump unit shall not be connected to the power outlet before the installation guide is read and understood.
This system is developed and built according to the regulatory safety standards, including:

• 60601−1 for basic safety and essential performance as a medical equipment class 1
• 60601−1−2 Electromagnetic disturbances, requirements and tests
• 60601−1−11 Medical electrical equipment used in the home healthcare environment
• 60601−1−6 Medical electrical equipment; usability

Always follow these precautions for your own safety and for product safety:

• Do not let the pump unit be close to water sources or other sources that can inflict water damage. Water will damage the electronics and potentially cause fire
• Keep the device away from fire sources such as cigarettes, matches or similar items, as this can cause fire
• Do not store the product under direct sunlight, as sunlight can cause the components to overheat and possibly reduce the products expected lifetime
• Only use suitable cleaning aids, as others may cause added wear to the product, or in a worst-case scenario, cause serious and/or irreversible skin damage to the patient
• Do not expose the product to sharp objects, knives etc, this may damage the product and disrupt its function
• Make sure the product is cleaned and dry before storage, if not, bacteria growth can occur, and the product may be harmful for the next user
• The product can safely be stored in the original packaging
• Make sure this manual is always available for reference
• The product shall only be used with the supplied approved power supply. The product is tested for electrical safety with this power supply, and the use of another power supply may cause risk of electric shock or fire
• Portable radio equipment, including antennas, may affect medical devices. Do not let any such equip-ment be closer than 30cm from the Tidewave™ Mattress, cables, or pump unit, as such equipment could cause product malfunctioning, which in a worst-case scenario could lead to patient pressure ulcers

WARNING
The use of Tidewave™ Mattress nearby or in conjunction with other electrical equipment should be avoided, such use could cause the product to malfunction. If such use is considered necessary, the product and its auxiliary equipment should be closely monitored to confirm normal operation is maintained. Electrical equ-ipment may be harmful if used in a manner not intended, or if the equipment is damaged. Make sure power is disconnected before any repair or maintenance work is performed to the equipment. Maintenance and repair work should only be performed by certified technicians.
Contact Tidewave Medical AS on e-mail: post@tidewave.no for any questions regarding the product.

Introduction

Product description

Tidewave™ Mattress is designed to give the user continuous movement to prevent and treat pressure ulcers up to and including grade 4. Tidewave™ Mattress consists of a specially developed foam mattress, air cells, and a pump unit with an intuitive control panel. The patient lies centred in the mattress and is slowly turned from side to side at a user adjustable pace and angle of rotation, either continuously or paused at each side. The mattress gives movement to the user in two sequences: First it curves to provide support, then it starts the turning sequence, which is the turning from one side to the other.

The system is designed to move so slowly and gently that the user’s sleep quality should not be disturbed.
The amount of time the different sequences take is dependent on the user selected pump speed and angle of rotation. From completely flat to curved the time ranges are approximately 40 minutes. For the turning sequence the time ranges are approximately 20-60 minutes. When the mattress is started, the turning sequence will run continuously until the stop button is pressed.

Application
Tidewave™ Mattress is meant to be used in professional and home health care. Tidewave™ Mattress is intended for patients of all ages to keep them in continuous movement to prevent pressure ulcers up to and including grade 4. See chapter 3.5.2 Mattress specifications for the various recommended patient weights.
This user manual is intended for health personnel and lay personnel, and in some cases for the patient themself.

Contraindication

• The product shall not be attached to the bed frame in such way that it may conflict with the bed’s mechanical movement.
• Tidewave™ Mattress shall not be used by patients under 9kg or above 150kg. See chapter 3.5.2. Mattress configurations for the various recommended patient weights.
• If the patient is mobile and likely to get out of the bed by themselves, even while the mattress is running, the use of this mattress must be risk evaluated by competent care provider before the product can be used.

How it works
Tidewave™ Mattress consists of a pump unit with an intuitive control panel and a foam and air cell combination that makes up the mattress part.
The mattress unique curved shape ensures that the patient lies safely in the center of the mattress and prevents that the patient falls out of the bed.

Patients with sufficiently moveability could get out of the bed by themselves on the low side of the side the mattress is turned towards, which could result in a fall accident. The siderails should therefore be 22 cm over the top of the lower side when the mattress is turned to the side, to prevent that the patient may get out of the bed by themselves. If the side rails are less than 22 cm from the top of the lower side of the curve when the mattress is turned to the side, or if no siderails are available, the patient must be under supervision to prevent potential fall incidents. If a healthcare professional is not available for assessment, then siderail raisers must be used to prevent the patient from trying to get out of bed by themselves.

The air cells are located under the foam mattress and is a dual layer consisting of 12 cells divided in 9 individual inflatable sections with different functionality:

1. Curving cells – The top layer of the air cells, curves up the mattress to provide support and pressure relief for the patient. The curving also increases patient safety during turning.
2. Turning cells – The bottom layer of the air cells, does the actual turning of the patient. Left and right sections consisting of 3 individual cells, provides an even and safe turning motion.

After the start button is pressed, the curving cells will start inflating. The curving will take approximately 40 minutes to complete. The curving cells stay inflated during the whole turning program to provide an even and safe lying position. The mattress and patient will turn synchronized from left to right at a continuous slow spe-ed. The patient is turned up to 30 degrees, depending on user settings. If selected, the mattress will pause at the side for a maximum of 30 minutes before resuming to turn towards the opposite side.

Technical data

3.5.1 Technical data sheet

Power supply: AMF36US24
Power| In: 100-230VAC ~ 50/60Hz, out: 24Vdc max 36W
Power consumption

during normal conditions

| 24W
Environment:
Ambient temperature| Min +10°C Max +30°C under usage, Min -20°C Max 60°C during storage
Pump unit:
Air pressure| ≤ 200mBarg1

1Depending on user settings, patient weight, and placement on mattress

For safety, the pump will shut down if the pressure surpasses 200mBarg

Noise level| 19dB according to ISO 3746:2010. 27 dB(A) according to test method 11-5 03/2004 (DE)
Weight pump unit| 5 kg
User settings| Turning direction, turning degree, pause on each side, speed, patient care

function, start and stop

Turning duration| Up to 1 hour to each side, depending on selected program
Air connection| One quick connector, containing 9 tubes
Pump unit dimension| 25x13x38cm
IP21| The pump unit protection grade is IP21, which means the unit is protected against ingress

of objects larger than 12.5mm (fingers) and vertical water drops, such as rain

Mattress article number:| 70. 1 60.001.EU-S| 80.200.001.EU-S

85.190.001. EU-S

85.200.001.EU-S

85.210.001.EU-S

90.190.001. EU-S

90.200.001.EU-S

90.210.001.EU-S

90.220.001.EU-S

| 80.200.001.EU-M

85.190.001. EU-M

85.200.001.EU-M

85 .210. 001. EU- M

90.190.001. EU-M

90.200.001.EU-M

90. 210. 001 . EU- M

90.220.001.EU-M

| 8 5. 1 90 . 00 1 .E U -H

85.200.001.EU-H

85.210.001.EU-H

9 0 . 1 9 0 . 001 . EU – H

90.200.001.EU-H

90.210.001.EU-H

90 . 220 . 001 . EU- H

Mattress type| Continuously and synchronized motion mattress consisting of foam mattress and air-cells
Foam type| Polyurethan HR cold foam
Air-cells| 9 individual
Material air-cells| PU coated nylon
Incontinence sheet| PU/Polyethylen (applied part)
Ignitability| Non ignition according to EN 597-1 and EN 597-2
Recommended patient

weight

| 9 kg – 40 kg| 40 kg – 60 kg| 55 kg – 115 kg| 110 kg – 150 kg
Max applied load| 200 kg
Mattress weight| See table 3.5.2
CPR quick deflate function| Yes, same as quick connector release
Fault state| Flat foam mattress
Mattress dimension| See table 3.5.2
Applied part| The mattress hygiene cover is defined as applied part BF. The cover is electrically insulated

from the rest of the equipment

IP24| The mattress protection grade is IP24, which means the mattress is protected against

ingress of particles larger than 12.5mm (fingers) and water splash from all angles

3.5.2 Mattress specifications

| Mattress variety and article number| Foam type Polyurethane HR cold foam|

Mattress dimension| Foam density (ISO 856)| Foam hardness (ISO 2439/B)| Mattress weight| Recommended patient weight
1| Tidewave mattress 70×160

/ 70.160.001.EU-S

| Soft foam 70×160

(TW-M0002)

| 70x160x10

cm

| 40kg/m3| 95 N| 13 kg| 9 kg – 40 kg*
2| Tidewave mattress 80×200 Soft foam

/ 80.200.001.EU-S

| Soft foam 80×200 (TW-M0077)| 80x200x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)

+ 300 N (sides)

| 18.3 kg| 40 kg – 60 kg*
3| Tidewave mattress 80×200 Medium foam

/ 80.200.001.EU-M

| Medium foam 80×200

(TW-M0078)

| 80x200x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)

+ 300 N (sides)

| 18.3 kg| 55 kg – 115 kg*
4| Tidewave mattress 85×190 Soft foam

/ 85.190.001.EU-S

| Soft foam 85×190

(TW-M0085)

| 85x190x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)

+ 300 N (sides)

| 18.7 kg| 40 kg – 60 kg*
5| Tidewave mattress 85×190 Medium foam

/ 85.190.001.EU-M

| Medium foam 85×190

(TW-M0086)

| 85x190x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)

+ 300 N (sides)

| 18.7 kg| 55 kg – 115 kg*
6| Tidewave mattress 85×190 Firm foam

/ 85.190.001.EU-H

| Firm foam 85×190

(TW-M0087)

| 85x190x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)

+ 300 N (sides)

| 19.3 kg| 110 kg – 150 kg*
7| Tidewave mattress 85×200 Soft foam

/ 85.200.001.EU-S

| Soft foam 95×200 (TW-M0081)| 85x200x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)

+ 300 N (sides)

| 19.1 kg| 40 kg – 60 kg*
8| Tidewave mattress 85×200 Medium foam

/ 85.200.001.EU-M

| Medium foam 85×200

(TW-M0082)

| 85x200x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)

+ 300 N (sides)

| 19.1 kg| 55 kg – 115 kg*
9| Tidewave mattress 85×200 Firm foam

/ 85.200.001.EU-H

| Firm foam 85×200

(TW-M0083)

| 85x200x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)

+ 300 N (sides)

| 19.8 kg| 110 kg – 150 kg*
10| Tidewave mattress 85×210 Soft foam

/ 85.210.001.EU-S

| Soft foam 85×210

(TW-M0088)

| 85x210x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)
+ 300 N (sides)

| 19.5 kg| 40 kg – 60 kg*
11| Tidewave mattress 85×210 Medium foam

/ 85.210.001.EU-M

| Medium foam 85×210

(TW-M0089)

| 85x210x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)
+ 300 N (sides)

| 19.5 kg| 55 kg – 115 kg*
12| Tidewave mattress 85×210 Firm foam

/ 85.210.001.EU-H

| Firm foam 85×210

(TW-M0090)

| 85x210x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)
+ 300 N (sides)

| 20.2 kg| 110 kg – 150 kg*
13| Tidewave mattress 90×190 Soft foam

/ 90.190.001.EU-S

| Soft foam 90×190

(TW-M0091)

| 90x190x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)
+ 300 N (sides)

| 19.1 kg| 40 kg – 60 kg*
14| Tidwave mattress 90×190 Medium foam

/ 90.190.001.EU-M

| Medium foam 90×190

(TW-M0092)

| 90x190x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)
+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)
+ 300 N (sides)

| 19.1 kg| 55 kg – 115 kg*

| Mattress variety and article number| Foam type Polyurethane HR cold foam|

Mattress dimension| Foam density (ISO 856)| Foam hardness (ISO 2439/B)| Mattress weight| Recommended patient weight
---|---|---|---|---|---|---|---
15| Tidewave mattress 90×190 Firm foam

/ 90.190.001.EU-H

| Firm foam 90×190

(TW-M0093)

| 90x190x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)
+ 300 N (sides)

| 19.8 kg| 110 kg – 150 kg*
16| Tidewave mattress 90×200 Soft foam

/ 90.200.001.EU-S

| Soft foam 90×200 (TW-M0056)| 90x200x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)
+ 300 N (sides)

| 19.6 kg| 40 kg – 60 kg*
17| Tidewave mattress 90×200 Medium foam

/ 90.200.001.EU-M

| Medium foam 90×200

(TW-M0057)

| 90x200x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)
+ 300 N (sides)

| 19.6 kg| 55 kg – 115 kg*
18| Tidewave mattress 90×200 Firm foam

/ 90.200.001.EU-H

| Firm foam 90×200

(TW-M0058)

| 90x200x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)
+ 300 N (sides)

| 20.3 kg| 110 kg – 150 kg*
19| Tidewave mattress 90×210 Soft foam

/ 90.210.001.EU-S

| Soft foam 90×210

(TW-M0094)

| 90x210x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)
+ 300 N (sides)

| 20.1 kg| 40 kg – 60 kg*
20| Tidewave mattress 90×210 Medium foam

/ 90.210.001.EU-M

| Medium foam 90×210

(TW-M0095)

| 90x210x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)
+ 300 N (sides)

| 20.1 kg| 55 kg – 115 kg*
21| Tidewave mattress 90×210 Firm foam

/ 90.210.001.EU-H

| Firm foam 90×210

(TW-M0096)

| 90x210x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)
+ 300 N (sides)

| 20.8 kg| 110 kg – 150 kg*
22| Tidewave mattress 90×220 Soft foam

/ 90.220.001.EU-S

| Soft foam 90×220

(TW-M0097)

| 90x220x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 100 N (bottom)

+ 300 N (sides)

| 20.6 kg| 40 kg – 60 kg*
23| Tidewave mattress 90×220 Medium foam

/ 90.220.001.EU-M

| Medium foam 90×220

(TW-M0098)

| 90x220x15

cm

| 40 kg/m3 (top)

+ 32 kg/m3 (bottom)

+ 63 kg/m3 (sides)

| 95 N (top)

+ 150 N (bottom)
+ 300 N (sides)

| 20.6 kg| 55 kg – 115 kg*
24| Tidewave mattress 90×220 Firm foam

/ 90.220.001.EU-H

| Firm foam 90×220

(TW-M0099)

| 90x220x15

cm

| 40 kg/m3 (top)

+ 37,5 kg/m3 (bottom)
+ 63 kg/m3 (sides)

| 95 N (top)

+ 185 N (bottom)
+ 300 N (sides)

| 21.3 kg| 110 kg – 150 kg*

Upper limit of recommended patient weight for optimal therapeutic load distribution is based on the risk of bottoming out when back section is raised over 30°. Lower limit of recommended patient weight for optimal therapeutic load distri-bution is based on the optimal envelopment.

Installation

If the product has been stored or transported in temperatures above or below specified operating temperature, give the product 30 minutes to adjust to operational temperatures before further installation. This is to make sure no harm to the product is caused by rapid temperature changes or by operating out of temperature range. This could affect the functions and/or damage the product.

1. Mattress
   Place the mattress on the bedframe with the foam side facing up. The connector air hose shall face the foot end and be threaded through the bedframe if suitable. Make sure the air hose is free to move and not pinched. Make sure the connector with the CPR push button is easily accessible for all personnel.

2. Pump unit
   Flip out the pump unit hooks and hang it on the foot end of the bed. Do not cover the pump unit, this could cause overheating and damage to the unit.

3. Quick connector
   Connect the mattress to the pump unit by pressing the connectors together. There will be a click sound whenthe CPR push button is locked in.

4. Power supply
   For the power supply, plug the DC power plug into the socket on the underside of the pump unit. Make sure it is plugged all the way in.
   Then connect the AC (mains) power plug to the wall socket.
   NOTE: Power socket must be easily accessible, as disconnecting from the power socket will separate the pump from the power source.

5. CPR / Quick connector verification
   Verify that the CPR mode is working by pushing the red CPR button and disconnect the connector. The red Service Light shall be indi-cated on the control panel and the pump shall stop. Reconnect the connector and verify the red service light goes off.

6. Ready for use
   The pump unit takes up to 30 seconds from the time it is plug-ged into the wall, until the system is ready for use. The lights on the control panel will go on when it is ready to start. The lights
   will automatically be switched off after 10 seconds of inactivity while not running. To switch the lights back on, press one of the settings buttons.

Take some time to familiarise yourself with the mattress safety functions and maintenance instructions in the next chapters, and eventually operating instructions, found in chapter 5.

Start up **

**

All factory settings are set at standard setting. Begin with low or medium turning degrees to allow the patient to get used to the turning function. This is sufficient for most patients. In case of other preferences, the different settings can be changed, refer to chapter 5.4 under settings. User settings only need to be configured once, as the pump unit remembers the settings configuration until it is manually changed.

1. Before starting the mattress, the patient should be positioned in supine (face up, centred in bed).
2. Use positioning cushions, if needed. Ensure that heels are properly offloaded.
3. To start the turning program, press start. The mattress will begin curving. This process will take approximately 40 minutes, and then the continuous turning starts.
4. For patient care mode (static), press the start button once more while the program is running. This activates a 30-minute stop.
5. To stop the turning program, press the stop button. The air cells will deflate, and the mattress will return to a flat state in a few minutes.
6. If you intend not to use the product for a while, it is recommended to unplug the AC (mains) power plug to minimize power consumption.

If the turning program is quickly restarted after a stop, there might still be some air left in the cells. In that case, the pump will initiate active deflation for up to 10 minutes before the program automatically resumes normal operation and starts the turning program. This is to make sure the turning cycles operates as intended.

In and out of bed
The turning program must be stopped before the user enters or gets out of bed. This is to avoid risk of harm to the user and/or the mattress.

Care function
The mattress can temporarily be paused for situations such as care or medical assistance. The regular duration of the care function is 30 minutes.

To use the care function, press the start button while the turning program is running. The green light will start blinking and the mattress will deflate to a flat position. After 30 minutes, the turning program will automatically resume or can be resumed earlier by pressing the start button again.

Postponed startup
By pressing the start button twice, the mattress will wait 30 minutes before the curving and turning pro-gram begins. This is useful for home healthcare as it enables the patient to start the mattress themselves and have enough time to get in bed. Postponed startup is also useful for patient who are sensitive to sound and movements, needing time to fall into sleep before the pump begins.

Settings
To choose a setting, press the round button accompanying the individual setting, one to three times. The active setting lights up on the panel.

Disconnecting

Disconnecting is performed in the opposite sequence of steps as the installation.

1. Unplug the AC (mains) power plug from the wall socket and disconnect the DC connector from the underside of the pump unit.
2. Disconnect the air hose by pressing the red CPR push button on the connector.
3. Lift the pump unit off the foot end of the bed and fold in the hooks.
4. Store the product in a dry and room temperature environment, keeping out of direct sunlight. The mattress should lie flat with the underside down during storage.

Cleaning and maintenance

Cleaning

Regular cleaning and disinfecting must be performed according to these instructions. Deviation from these instructions may void the manufacturer’s warranty. Avoid cleaning internal components such as the foam, tubes, or air cells, doing so might deteriorate function. It is recommended to clean the cover of the mattress and the pump unit surfaces weekly or when the mattress is assigned to another patient, to prevent spreading of bacteria and viruses. Washing instructions for special cases are for whenever there is a suspicion of conta-gion, infection, or difficult stains.

Standard cleaning and disinfection procedure
Mattress
Apply disinfectant liquid (alcohol <95% or chlorine <5%) to the hygiene cover and wipe off with a damp cloth (hot water) within 2 minutes of application. Longer exposure to these chemicals will increase the wear of the hygiene cover and could leave traces which may irritate the patient skin.

Pump unit
Wipe down with a damp cloth. If there is a suspicion of bacteria or virus, or especially difficult stains, disinfectant liquid (alcohol < 95%) can be used.

Cleaning procedure for special cases

1. Disconnect the AC (mains) power plug.
2. Disconnect the pump unit from the mattress by pressing the red CPR push button.
3. Open the top zipper to extract the top section of the hygiene cover. Place the rest of the mattress in a suitable clean and dry location.
4. The hygiene cover can be washed on normal wash up to 70°C, and can be dried in a tumble drier up to 60°C. Do not bleach, iron nor dry-clean the hygiene cover.
5. After wash, inspect the hygiene cover for microscopical damages or holes by holding the cover up to a light source. If any holes or damages is found, replace the hygiene cover as it could become a potential source of infection of biohazardous organisms which in worst case could cause death.

Safety functions

CPR – Cardiopulmonary resuscitation
In case of an emergency where there is a need to quickly return the mattress to flat position, press the red CPR button on the quick connector. This will disconnect the air hose and release the air rapidly. The pump unit service indicator will show a red light, and the pump will stop. The quick connector must be correctly reconnected before the system can be started again.

NOTE: The foam mattress is soft. Use a CPR board placed between the patient and the mattress before performing CPR.

Back section
The system can operate with the back section raised up to 30 degrees.

If the back section is raised too high, the turning motion will temporarily stop and the “back section over 30 degrees” indicator will show a red light. The turning will resume as soon as the back section is lowered to 30 degrees or below.
The turning program must be stopped or put in static mode before the back section is raised to a sitting position for medication, care etc. This is to avoid risk of harm to the patient or damage to the mattress.

Alarm sound
In the case of a malfunction, detection of an error or power loss preventing the mattress to be working as normal, the mattress will function as an ordinary foam mattress. There is therefore no immediate or reaso-nably delayed risk of a harm, hence no audible alarm as this could give misleading information to users and healthcare providers.

System fault state

Service indicator

Check connector
Check if the air hose is connected. Pull it gently to make sure the connector is properly engaged.

Check cable
Make sure that the air hose is not in a tight bend or pinched between the mattress and bed frame.

More than 30° backrest

• If the backrest is raised above 30°, the turning program will stop and the > 30° lights up.
• When the backrest is lowered to 30° or below, the mattress will automatically resume.
• • If none of the above seem to be the problem, check out the troubleshooting guide in chapter 9.2.

Troubleshooting guide

(mains) power plug to wall socket, refer to chapter 4. Installation
There is no power in the outlet| Use another outlet
Power cord is damaged| Contact a certified Tidewave™ service techni- cian
DC power plug is not connected| Make sure the DC power plug on the bottom side of the pump unit is properly connected
Service indicator shows a red light| Check if the air hose is connected and properly engaged
Back section high indicator shows a red light| Lower the back section to 30 degrees or below
Back section high indicator shows a red light even if the mattress is flat| Open the bottom zipper on the mattress, to access the air cells and check if they are oriented the right way up, as illustrated in chapter 7.3. If in doubt, contact a qualified Tidewave™ service technician
Service indicator shows a red light| Air hose is disconnected| Connect the air hose as demonstrated in chapter 4.3 and wait one minute and try to start
System needs rebooting| Disconnect the AC (mains) power plug from the wall socket, wait 10 seconds before plugging it back in
Air hose is pinched| Make sure the air hose is free to move and not pinched, refer to chapter 4.1 Mattress. Reset the service indicator red light by pressing and

holding the stop button for at least 10 seconds or until the service light turns off

Other| If the service light is still showing a red light: Con- tact a qualified Tidewave™

service technician

Patient is not turned properly| System is not plugged in| Make sure the AC (mains) and DC power cords are connected and start the system See chapter 4. Installation
Patient is not centred longitudinally in the bed| Reposition the patient until centred in bed
Patient has spasm| Turning might be difficult to observe if the patient has spasm, wait until the spasm ceases and observe for 10 minutes to confirm the sys- tem is operative
Back section elevated over 30°| Lower the back section to 30° or below. See chapter 8.2 Back section
Pump unit defect| Contact a qualified Tidewave™ service technician
Error| Cause| Solution
---|---|---
Mattress is not inflated| Pump unit is not powered| Connect the power, see chapter 4
Quick connector is not connected| Connect the quick connector. Make sure the lock is properly engaged. See chapter 4.3 Quick connector
Air hose or connector is damaged| Contact a qualified Tidewave™ service technician
Pump unit defect| Contact a qualified Tidewave™ service technician
Back section elevated over 30°| Lower the back section to 30° or below, see chapter 8.2 Back section
Nearby electrical equipment is interfered| Electromagnetic interference cau- sed by unintended radiation form the device. These electromagnetic radia- tion waves are transferred through air and can cause nearby equipment to malfunction| Determine if the interference is caused by the Tidewave™ Mattress by powering off the pump unit.
If the interference disappears when the pump unit is off, try the following steps if possible:

• Move the affected equipment further away from the mattress
• Increase the distance between the equipment
• Connect the equipment or the Tidewave™pump unit to another wall socket, powered by a different circuit

If interference is still present, contact a qualified Tidewave™ service technician

Repairs, service and maintenance

Repair and service shall only be conducted by technicians approved and trained by Tidewave Medical AS and only with original Tidewave™ Mattress spare parts. If this is not followed, manufacturer warranty may be voided. Incorrect service or repairs can cause product malfunctioning, risk of electric shock, fire, serious injuries, or death.
Service is recommended, at a minimum, every 24 months. Service personnel have access to a service instruction manual with more in-depth information regarding service and repairs.

Maintenance
Inspect the incontinence cover, air hose, connector, pump unit, power cord, power supply etc visually for wear and tear. In case of damage to components such as power cord, power supply, pump unit or mattress, or in case of a fault state that cannot be addressed by the trouble shooting guide in chapter 9.2, contact a qualified Tidewave™ technician. In both cases the product shall be disconnected and not used until the product is repaired.

Product life expectancy
Expected product life is 10 years with normal use and replacement of wearing parts. Wearing parts such as hygienic cover, foam mattress and power supply has a life expectancy of 5 years. Normal use is defined as standard settings and a maximum of 12 running hours per day (24hrs). Settings other than standard, for example: high pump speed, high turning angle, no pause, will increase the product wear. More than 12 hours running time per day will also increase the product wear. During these conditions, shorter product life is to be expected.

Storage
The mattress and pump unit are to be stored in a dry environment, kept out of direct sunlight in tempera-tures between -20°C to +60°C and humidity between 5% and 95%.

Transport

• During transport, the product must be handled with care. Avoid heavy objects on top of the product, this may damage or deteriorate the product causing it to not work correctly or to not work at all
• Do not expose the product to direct sunlight over long periods of time, as this may damage the components or shorten the product’s life expectancy
• Do not use a sharp object to open the transport packaging, this might damage the product causing it to malfunction and misbehave or to not work at all
• Avoid exposing the product to moisture during transport as this may damage the components resulting in shorter life expectancy or cause the device to not work at all
• Avoid temperatures under -20°C or over 60°C as this may shorten the product life expectancy or damage the components causing them to malfunction or not work at all

Other considerations

• Original power supply is type AMF36US24. The product shall only be used with this power supply,
  as other power supplies are not tested and might cause hazardous situations such as fire

• Wall socket used for the power supply shall be easy accessible, enabling disconnection for separating the pump unit from the power mains

• In case of emergency where the air must be deflated as quick as possible, push the CPR push button on the quick connector, and the air will be released. The pump unit will automatically detect the disconnection and stop

• Avoid the use of sharp objects around the product, as this can cause damage to the air cells and inter-fere with the product’s functionality

• The mattress can be used with a fitted or stretch cotton sheet or equivalent

• Use pillows or a similar item to further increase pressure distribution around the heels of the patient

• If service indicator is showing a red light, or there are some other issues with the product, follow the trouble shooting guide steps in chapter 9.2

• The mattress and pump unit can be delivered to qualified Tidewave™ service personnel for recycling after end of product life. Tidewave™ service personnel will then handle recycling according to local government instructions and biological evaluation of the product

• The product is tested and approved according to 60601-1-2 electromagnetic disturbances, but nearby equipment may interfere or be interfered with by the product. In the case of interference, follow the trouble shooting guide in chapter 9.2

• During use, recommended room temperature is between +10°C to +30°C, atmospheric pressure between 700 hPa to 1060 hPa, and humidity between 5% and 95% for longest possible product life expectancy

Accessories and spare parts
Available spare parts and accessories for the product 90.200.001.EU are:

| Description| Article number
---|---|---
| Pump unit|

TW-AP / TW-DEV0006

|

Transportation box for the pump unit

|

TW-DEV0007

| Air cells: 90×200 / 80×200 / 85×200| TW-ASSY0018
Air cells: 70×160| TW-ASSY0002

| Hygienic top cover: 70×160| TW-M0004
Hygienic top cover: 80×200| TW-M0079
Hygienic top cover: 85×190| TW-M0100
Hygienic top cover: 85×200| TW-M0080
Hygienic top cover: 85×210| TW-M0101
Hygienic top cover: 90×190| TW-M0102
Hygienic top cover: 90×200| TW-M0003
Hygienic top cover: 90×210| TW-M0103
Hygienic top cover: 90×220| TW-M0104

| Soft foam 70×160| TW-M0002
Soft foam 80×200| TW-M0077
Soft foam 85×190| TW-M0085
Soft foam 85×200| TW-M0081
Soft foam 85×210| TW-M0088
Soft foam 90×190| TW-M0091
Soft foam 90×200| TW-M0056
Soft foam 90×210| TW-M0094
Soft foam 90×220| TW-M0097
Medium foam 80×200| TW-M0078
Medium foam 85×190| TW-M0086
Medium foam 85×200| TW-M0082
Medium foam 85×210| TW-M0089
Medium foam 90×190| TW-M0092
Medium foam 90×200| TW-M0057
Medium foam 90×210| TW-M0095
Medium foam 90×220| TW-M0098
| Description| Article number
---|---|---

| Firm foam 85×190| TW-M0087
Firm foam 85×200| TW-M0083
Firm foam 85×210| TW-M0090
Firm foam 90×190| TW-M0093
Firm foam 90×200| TW-M0058
Firm foam 90×210| TW-M0096
Firm foam 90×220| TW-M0099
| Transportation cover 80×200 / 85×200 / 90×200| TW-M0067
Transportation cover 70×160| TW-M0072
|

24V Power Supply

| AMF36US24 / TW-E0046

Contact your local Tidewave™ Mattress distributor for more information about accessories and spare parts.

 Warnings and symbols

Notes

Contact information

Manufacturer information

Tidewave Medical AS Hillevågsveien 101
4016 Stavanger
E-mail: post@tidewave.no www.tidewave.no

Distributor and service personnel

EUROPE

Norway

• Bano Life AS
• Tel: +47 64 91 80 60
• E-mail: post@banolife.no
• www.banolife.no

Denmark

• Ferno Norden Danmark A/S
• Tel: +45 43 62 43 16
• E-mail: fas@fernonorden.com
• www.fernonorden.com

The Netherlands

• TR-Care
• Tel: +31 085 485 83 90
• E-mail: info@tr-care.nl
• www.tr-care.nl/

ASIA PACIFIC

• Singapore
• IDS Medical
• Tel: +65 66 90 73 30
• E-mail: sgpinfo@idsmed.com
• www.idsmed.sg

West Australia

• AC Mobility
• Tel: +61 (08) 9209 1777
• E-mail: sales@acmobility.com.au
• www.acmobility.com.au

South Australia

• Medimart
• Tel: +61 1300 633 063
• E-mail: customersupport@medimart.com.au
• www.medimart.com.au

MIDDLE EAST

• Qatar
• Aamal Medical
• Tel: +974 4403 9550
• E-mail: aamalmed@aamalmed.com
• www.aamalmed.com

Kingdom of Saudi Arabia

• Mediserv
• Tel: ++966 114 780 555
• E-mail: info@mediserv.com.sa
• www.mediserv.com.sa

United Arab Emirates

• Leader Healthcare
• Tel: +971 4 3263980
• E-mail: helpdesk@leaderhealthcaregroup.com
• www.leaderhealthcaregroup.com

Kuwait

• Leader Healthcare
• Tel: +965 22461967
• E-mail: helpdesk@leaderhealthcaregroup.com
• www.leaderhealthcaregroup.com

QUICK GUIDE INSTALLATION

Tidewave™ Mattress

Step by step

• Place the mattress in bed with the hose towards the foot end.
  • With the foam side pointing up.
• Guide the hose through the base of the bed. Make sure it is not squeezed or pinned.
• Attach the pump unit to the foot end of the bed and connect it to the mattress (audiable click).
• Connect the power cord to the pump unit and then to a wall socket. Then wait 30 seconds.
• After 30 seconds the panel on the pump unit will light up. The mattress is now ready for use.

See our instruction video

Step by step

• Before starting the mattress, the patient should be positioned in supine (face up, centered in bed).
• Use positioning cushions, if needed. Ensure that heels are properly offloaded.

To start the turning program, press start.
The mattress will begin curving. This process will take approx. 35 mins, and then the continuous turning starts.
For patient care mode (static), press the start button once more while the program is running. This activates a 30 min. stop.

To stop the turning program, press stop.
Standard settings gives 20° turning degree both ways, at medium turning speed and a 15 min delay on each side.

QUICK GUIDE CUSTOM SETTINGS

Tidewave™ Mattress

Choose settings

Turning direction
It is possible to exclude the patient’s sides from being loaded.

Exclude the patient’s right side Turn in both directions Exclude the patient’s left side

Turning degree
Adapt the turning degree to the patient’s health condition.

Patient is turned to 30°
Patient is turned to 20°
Patient is turned to 10°

Delay on each side
The turning can be delayed at the end of a turn based on need.

30 minutes delay on each side
15 minutes delay on each side Continuous movement, no delay

Turning speed
Choose between 20-60 minutes from one side to the other.

High speed: 20 minutes
Medium speed: 40 minutes
Low speed: 60 minutes

Custom settings
To choose a setting, press the round button accompanying the individual setting, one to three times. The active setting lights up on the panel.

Check connector
Check if the air hose is connected, pull it gently to make sure the connector is properly engaged.
Check cable
Make sure the air hose is not in a tight bend or pinched between the mattress and bed frame.

More than 30° backrest
If the backrest is raised above 30°, the turning program will stop and the

30° lights up.
When the backrest is lowered to 30° or below, the mattress will automatically resume.

Check the user manual
If none of the above seem to be
the problem, check out the trouble- shooting section of the user manual or call your service technician.

Dokumentet ble publisert 05.2024
Copyright © Tidewave Medical AS
This document is submitted in confidence and contains proprietary information which shall not be reproduced or transferred to others for the purpose of manufacture, tender or any other intentions without written permission of Tidewave Medical AS

Quality of care, quality of life

Being an immobile patient normally means discomfort due to prolonged time in one position and thus sleep is interrupted when being repositioned.

The user
Using the Tidewave means a long healthy sleep and less pain – thus reductions in pain medication. Exisiting wounds can start to heal. The Tidewave Mattress promotes the feeling of autonomy and well-being for the user.

The next-of-kin
Relatives and next-of-kin get peace of mind knowing that their loved ones are continuously moving with the mattress. Improving quality of life.

Healthcare personnel
Reduction of sick leave and heavy manual handling. More time for patient- oriented work. The Tidewave Mattress can relieve the daily workload. Less strain on carers thus easier to recruit new.

The institutions
Optimal repositioning frequency without the need for human resources. Reducing the prevelance of pressure ulcers and a reduction in cost of wound management.

Reach out to our distributors
www.tidewave.no/contact

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