Kalogon A5NO PT-FR Smart Cushion Wheelchairs User Guide

: May 15, 2024
: Kalogon

Kalogon A5NO PT-FR Smart Cushion Wheelchairs User Guide

General

Thank you for choosing Sentinel, Powered by Kalogon. To ensure safe use of the device, it is important that you read this manual before use. In the manual, the user is the person sitting on the cushion. The clinician as referred to throughout these instructions is a suitably experienced person such as an occupational therapist, physical therapist, or other medical professional. Information on how people with impaired vision can access the manual can be found in our pre-sales information guide at www.etac.com. Other information can also be found at www.kalogon.com. Kalogon is continuously improving its products and reserve the rights to change the product and associated apps without prior notice.

Product Description

Sentinel, Powered by Kalogon is an air management system designed as an accessory for vertical air cell cushions to maintain the air level, which is set by a clinician to suit the individual’s weight, body shape, and pressure redistribution requirements.

Intended Use

The product is intended to maintain the internal air pressure of a single- chamber, vertical air cell cushion as set by a suitably experienced person. It is designed for use in a Home Healthcare Environment and intended to be used in indoor and outdoor environments in conjunction with a compatible vertical air cell cushion in a wheelchair.

Intended User

The product is designed for wheelchair users and others assessed as requiring a single chambered air cell cushion. This is typically for individuals who are at risk of pressure injuries. There is no minimum/maximum user weight limit, provided the user is within the set weight limit and size requirements for the connected cushion. The product is suitable for individuals with existing pressure injuries when used in accordance with national and international guidelines, such as the EPUAP/NPIAP Best Practice Guidelines, and as assessed by experienced professionals.

Limitation of Use

The connected cushion must be properly sized for the user and their seat. The product is not designed for use in heavy rain.

Cushion Compatibility Sentinel

Sentinel is compatible with the Star Standard Air and Star StabilAir cushions. A compatibility agreement exists between Etac and Kalogon guaranteeing Sentinel be compatible with certain Star cushions.

Ensure the cushion being used is listed below before installing Sentinel:

Etac Star StabilAir
- High Profile (10 cm / 4 in)
- Mid Profile (7.5 cm / 3 in)
Etac Star Standard Air
- High Profile (10 cm / 4 in)
- Mid Profile (7.5 cm / 3 in)
- Low Profile (5 cm / 2 in)

Sentinel has been designed for use with most major brands of single-cell air- floatation cushions. For compatibility with other brands, contact the cushion manufacturer for guidance.

Contraindications

While the product can be physically connected and used with multi-chamber cushions that feature a single locking mechanism, e.g., Star Star Lock, the product is only compatible with the cushion while the lock is open and, therefore, is not recommended.

Special Considerations

The assessment for and set up of the product should be carried out by a clinician, including the appropriate adjustment of air in the connected cushion to suit the individual’s pressure and postural needs in accordance with the cushion’s user instructions.

Precautions

Make sure to perform routine offload procedures recommended by clinicians to reduce pressure injury risk.

Warranty

2-years guarantee against material and manufacturing defects. For terms and conditions, see www.etac.com.
Service life of 5 years based on typical use by a single user. For complete information regarding the service life of the product, see www.etac.com

Sentinel, Powered by Ka logon & Included Components

Sentinel device
Silicone hose
USB-C charger

Product Overview/ Figure A

Status – Green
Charging – Yellow
Error/Leak – Red

A: Pause
B: Alarms On/Off

Getting Started/ Figure B
Ensure Sentinel is Charged

Plug the USB-C cable into Sentinel and then the other end of the cable into the correct wall plug for your region.
Plug the wall plug into wall socket. A yellow charge light will turn on.
Charge until the light turns solid. This indicates that the device is fully charged.
Click button A or B to wake the device. The device is ready for use when the green light is flashing slowly.

Battery life varies from 24 to 56 hours of continuous seated usage from a single charge. If the connected cushion has a leak, battery life may be shorter, as the pump will work hard to keep the cushion inflated.

Attaching Sentinel to the Cushion/ Figure C

Ensure the user is not sitting on cushion.
Check the hose length is correct for the size of the cushion. If required, the end of the hose may be cut to length during setup using sharp scissors ensuring there is enough hose length to avoid kinks. Do not cut the tube shorter than 15 centimeters. Replacement hoses are available as a replacement component if required.
Twist the valve counterclockwise to open the cushion relief valve.
Push the tube over the open valve.
Massage the tube onto the valve until it fully covers all areas of the valve.
Review connection to ensure that the attachment tube is not bent or kinked.
Place Sentinel into the cushion pocket so that the device faces away from the user with the round portion of the Sentinel facing upwards. Alternatively, a clip is available as an accessory to affix the device to another part of the wheelchair. Do not clip the product to the user.
When the user sits down the device will detect the user has sat down, and the green light will turn on.

Downloading the App
Download the “Kalogon” app from the Apple store for Apple devices, or the Google Play Store for Android devices.

Connect Sentinel to the App/ Figure D

Open Kalogon app.
Wake the device by clicking either button A or button B OR by sitting down on the cushion.
Press Alert button (B) on Sentinel for three full seconds, activating pairing mode. The Red, Yellow and Green lights will turn on and off. In app, select “Scan for cushions.”
Once the device is discovered by the app select “Connect” on the rectangle.
Select your language or leave as sounds.
Check for firmware updates and download if needed

Set and Adjust Pressure with the Kalogon App/ Figure E
Pressure settings should be established by a clinician.

Sentinel will automatically adjust to a factory default level for safety. This must be adjusted to each individual user prior to usage.
Check the cushion air level by using the method set out in the cushion Manufacturer’s Manual, e.g., a hand check to determine if the cushion requires more or less air.
In the app, drag the line up or down to increase or decrease the level of air in the cushion.
Once you release your finger from the line, the Sentinel saves this pressure setpoint.
Wait while the larger green rectangle rises or falls to meet the green line. The green rectangle represents the real time pressure of the cushion.
Manually check the air level in the cushion again, repeating steps 2-5 until the current desired level of air is achieved.
The air pressure setpoint is automatically saved by Sentinel. The device will then maintain this level of air when the cushion is occupied by the user.

Changes to the air pressure setpoint can be made in the future by pairing with the app again.

“Clinician Mode” Set and Adjust Pressure without the App/ Figure F

Sentinel is set to a default pressure level to start, which must be adjusted to the desired pressure following the cushion’s user instructions.
Press button A or B to wake the device.
Press both Pause (A) and Mute Alert Button (B) for five full seconds to enter Clinician Mode.
When all three lights begin blinking, Sentinel is in Clinician Mode.
Check the cushion air level by using the method set out in the cushion manufacturer’s manual, e.g., a hand check to determine if the cushion requires more or less air.
Use Pause Button (A) to adjust the air pressure downwards and Mute Alert Button (B) to adjust the air press upwards as required. The device will inflate or deflate for the duration of time either button is held.
After the buttons have not been pressed for 30 seconds, Sentinel will save the pressure setpoint and exit Clinician Mode.

If inflating the cushion, the user should lift off the cushion slightly to allow the cushion to fill properly. If the user is unable to lift up, lean side to side.

Sentinel will not react to pressure changes caused by the user while in Clinician Mode. The air level must be checked using the method described in the cushion manual, e.g., a hand check to verify the proper pressure has been set.

Placement
Once set up, place Sentinel in the cushion pocket or attach to the chair using the optional clip.

Pause Mode
Pause Mode is intended to temporarily cause Sentinel to stop all activity and responsiveness to external pressure changes or user movement. The device will maintain the seal on the valve and as such the cushion will retain the previously set level of air and is therefore safe to be used.
This may be desirable if the user wishes to stop the device’s activity for a period of time. This also allows for a hand check as per the cushion manufacturer’s manual to be performed. If the pause mode is not exited, Sentinel will automatically exit pause mode after 30 minutes.

Sentinel is designed to maintain a clinically prescribed level of air and therefore is not guaranteed to prevent bottoming Out

With Sentinel connected to the cushion and user seated on cushion, press down the Pause Button (A) for at least 1 second.
When Pause Button (A) is released the Sentinel will enter pause mode, an audible note will be heard, during which Sentinel stops adjusting to pressure changes but does not affect the air-tight nature of the device.
Pause mode can be exited by pressing again on the Pause Button (A) for 1 second, and releasing. An audible note will be heard.

Alerts On/Off
This turns off auditory alerts. Visual alerts in the form of solid/blinking lights will continue.

Check for leaks
Cushion airway blocked
Battery low
Charging error

The device emits audible sounds when the user sits on their cushion or transfers off. These sounds can be disabled via the settings panel in the app or using the button on the devie.

Wake the device by briefly pressing either button OR by sitting down
Turn off Alerts, press down on the Alerts Button (B) for 1 second, then release.
To turn Alerts back on, press down on the Alerts Button(B) for 1 second and release.
Alerts automatically turn back on after 30 minutes.

Ongoing Usage Indicators
Sentinel provides ongoing information based on colored lights which can be viewed from the top of the device and the side.

Green Light
Solid Green: Sentinel detected user’s presence
Blinking Green: Sentinel detects user transferred off
Yellow Light
Slow blink when plugged in: Charging
Fast blink when unplugged: Low on battery
Solid when plugged-in: Fully charged
Red Light
Solid Red : Check for leak
Blinking Red: Closed vent valve detected OR kinked tube detected prior to initial use

If a leak is detected the device will audibly state “check for leaks” once every 5 to 10 minutes while the leak is occurring. Consult with your cushion manufacturer for recommended cushion repair techniques.

Audio Cues
Audio indicators happen for the following situations. Please review information under Alerts On/Off.

Low battery – battery is under 10% of fully charged
At battery levels of 5% and lower, the device will shut off to preserve overall battery longevity
Check for leaks – The device alerts when a leak is possible
Clinician mode activation/deactivation
Pairing mode activation
Person detected on cushion – The device produces an alert when it detects the user getting up or sitting down
Closed vent valve detected

Removing Sentinel

Users should NOT be sitting on the cushion when detaching Sentinel.
Disconnect Sentinel and the cushion at the attached cushion relief valve – this may take some wiggling to disconnect.
Close vent valve on cushion after disconnecting Sentinel.

Caring for Sentinel

Sentinel can be cleaned with the following:

A dry cloth
A slightly damp cloth
Wiped carefully with an 70% or less IPA -based or antibacterial cleaning wipe
A light blast of air to remove any visible dust from the outlet tube or around the seams of the enclosure

Product Reuse

Sentinel may be re-used with different cushions as needed.
If for example, a cushion is replaced, Sentinel may be disconnected from the original cushion and attached to a new cushion.

The device can be reused only if the cushion complies with the manufacturer’s original general safety and performance requirements.

Every time Sentinel is added to a new cushion, adjustments must be made to pressure settings. You must follow installation instructions to install on a new cushion.
The product conforms to the requirements of the Medical Devices Regulation (EU) 2017/745.

Training Requirements

Sentinel is designed to be easy to use. A clinician capable of performing a hand check test is necessary to properly set the air-inflation of the cushion when using Sentinel for the first time.

Technical Data Configurations:

Sentinel comes with a hose length of at minimum 30cm ( ~12’’). The user or clinician is instructed to cut hose length.
Sentinel is provided with a default pressure value that must be modified by the clinician or end user.
A clip can be provided upon request to attach Sentinel to a mounting point or strap.

Lifting Points

Sentinel should not be handled by the hose. Always pick up Sentinel by the main body of the device.

Accessories

Sentinel comes with a clip that can be used to attach the device to a cushion.

Pre-Sales Information
Prior to ordering Sentinel it is important to verify the cushion intended for use is compatible with the device. Reference the cushion compatibility section of the user instructions for verification.

Safety Measures User:

Sentinel can maintain the pressure set by the user or clinician. The device is capable of adjusting this pressure over time as the user’s weight changes or ambient conditions fluctuate. Sentinel cannot augment or replace routine pressure offloads, and failure to do these offloads may increase risk of pressure injury.

Caregiver:

Sentinel cannot determine the correct pressure for a given individual on their cushion. Rather, Sentinel provides a range of pressures the caregiver or clinician can select and verify using hand check or similar methods. Never assume Sentinel has been properly set up upon first installation. Two-finger palpation must be performed to verify the correct pressure is set.

Environment:

Sentinel does not require the user to calibrate the internal pressure sensor of the device.
Sentinel cannot be used in extreme temperatures or used in harsh outdoor conditions.

Storage and Nominal Usage

**Short term (2-day max)

Do not expose Sentinel to heavy rain or splashes of water. If the device is not used for a significant period of time it must be stored at room temperature in a dry environment. Avoid using Sentinel in a dusty environment.

Do not use Sentinel at elevations above 10,000 ft. / 3,048 meters. Sentinel will work in pressurized environments such as an aircraft, pressurized to 6,000 ft/ 1,829 meters.

Transport, Storage and Disposal Transport:

Sentinel is compliant with UN 38.3 Air Transport regulations. Regulations differ by country. Please consult with your local regulatory authorities for specific information.

Storage:

Sentinel should be stored at room temperatures (~25C / ~77F) and humidity lower than 75%.

Disposal:

Remove charging cable if attached to Sentinel prior to preparing for disposal.
Fully discharge battery, verify this by confirming pressing either of the Sentinel buttons results in no lights turning on.
A fully-discharged battery is less susceptible to a thermal event.
Dispose of Sentinel through electronic waste disposal facilities in accordance with local environmental regulations. Kalogon complies with WEEE 2012/19/EU

Troubleshooting

If the unit is pumping often the hose may not be correctly installed. Check your connections.

If repeated “cushion airway blocked” notifications occur when the cushion valve is open, the hose length of the unit may be too long and should be shortened as per instructions.

Refer to online resources available at www.kalogon.com or contact your Etac sales representative for more information.

WARNINGS
This device is an accessory to a vertical air cell cushion. It is designed to assist in the setup and maintenance of the Cushion. It does not replace cushion manufacturer setup and maintenance processes. See the manufacturer’s cushion manual for instructions on specific cushion setup

WARNING: DO NOT sit on the cushion when not inflated or before Sentinel is installed. It is unsafe to sit on a vertical air-cell cushion devoid of air.

WARNING: Sentinel default levels are factory settings and should not be taken as clinical recommendations.
Sentinel is designed to maintain a clinically set level of air as set by the user’s clinician and as such cannot prevent bottoming out; a suitably experienced person should check cushion status as per the cushion’s manual to ensure the correct level of air is achieved.

WARNING : A clinician should check levels using the recommended method by the cushion manufacturer’s manual.

WARNING: Turning auditory alerts off does not cure the problem that the user is being alerted to. Ignoring an alarm may place the user at risk. The alarm will sound again after 30 minutes if the underlying cause has not been resolved.

WARNING: DO NOT sit on the cushion when detaching Sentinel. If user is sitting during detachment, air in the cushion could leak rapidly out of the open fill valve and bottom out the user.

WARNING: After Sentinel is disconnected, DO NOT sit on cushion until the valve is fully closed.

Sentinel cannot replace the need to perform skin checks and cannot prevent the cushion from bottoming out.
Contact your clinician if you have any concerns regarding cushion pressure settings.
Sentinel does not replace the need to perform regular pressure shifts.

WARNING: DO NOT let Sentinel dangle, it must be clipped to a chair or cushion without a kink in the hose or be retained in a cushion pocket or via a wheelchair bracket.

WARNING: DO NOT clip Sentinel to the user.

WARNING: DO NOT use Sentinel while showering or with a shower cushion, Sentinel must be used on a cushion with a cover properly installed according to the cushion user manual.

WARNING : DO NOT tug on Sentinel while it is in use.

WARNING : Charge with provided USB-C and wall plugs, do not use third party cables or plugs.

WARNING: DO NOT use Sentinel if there is any visible damage to the Sentinel unit or tubing.

WARNING: DO NOT use Sentinel if it has been submerged in water or exposed to heavy rain.

Sentinel will not function in temperatures above 131 degrees F/55 degrees C.
When not in use, Sentinel should be stored at room temperature and should not be exposed to extreme temperatures or direct sunlight for extended periods.

WARNING: User must check Sentinel is working prior to each use.

Sentinel needs charging. Ignoring the low battery warning will stop the device from functioning correctly.
When fitting the hose, always ensure it is fitted fully over the valve and routed in such a way that it is not at risk of accidental detachment or kinking.

WARNING: Sentinel contains a lithium-ion battery. These batteries can develop a thermal event if damaged.
Thermal events can cause a warming of the battery or release smoke and vapor. Never attempt to remove the lithium ion battery from Sentinel as this can damage the battery.

WARNING: If the outlet hose is visibly damaged or if you have questions regarding the seal of the hose to the cushion, refrain from using sentinel until the proper seal can be verified.

WARNING : Sentinel must never be cleaned by or exposed to any of the following; acetone or any other caustic cleaners, Sunscreen, Dishwasher, Running water, Stagnant water or liquid, Bleach, Chlorine based solutions.

WARNING: Ensure the device does not apply pressure to the user’s legs when placed in the pocket or clipped to the cushion handle, as this could potentially cause pressure injuries.

WARNING: Check to make sure the device does not press into the legs when device is in the cushion pocket

WARNING: In the case of any serious incident occurring in relation to the device, this should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

WARNING: While in clinician mode, ensure the hose is not obstructed or bent in a way to prevent air flow.

WARNING: While using clinician mode, the user must remain seated until clinician mode is exited.

WARNING: DO NOT sit on the cushion while Sentinel is connected to the cushion and charging. Always ensure the device is disconnected from its charger during use.

WARNING: Do not modify, alter, or disassemble Sentinel outside of modifying the hose length.
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