Alert-iT P176A Companion Mini Pro Plesio Pager Handbook User Manual

P176A Companion Mini Pro Plesio Pager Handbook

Specifications

• Product Name: Companion Mini Pro
• Model: P176A, P176B, P137
• Firmware Version: v1.0 (P176A, P176B), v9.3 (P137)
• User Manual Version: 9.0.0
• Release Date: 31 May 2024

Product Information

Intended Use

The Companion Mini Pro is designed to detect repetitive movement
in the bed to alert caregivers of potential seizures. It is
suitable for use when the individual is in bed, whether during the
day or night.

Intended Users and Use Environment

Intended for both laypersons and healthcare professionals, the
Companion Mini Pro can be used in various settings including homes
and professional healthcare environments.

Intended Patient Population

The product is suitable for individuals over 3 years old who
require monitoring while in bed.

Device Lifetime

In normal home use, the product has a typical lifespan of 5
years. It should be replaced after this period or earlier if damage
is observed. Replace batteries when needed.

Product Usage Instructions

Safety Precautions

Follow these safety precautions to ensure safe operation of the
Companion Mini Pro:

• Do not attempt to repair the device yourself; contact your
  equipment provider for assistance.

• Avoid exposing the device to liquids or extreme
  temperatures.

• Regularly inspect the device for any signs of damage and
  discontinue use if any are found.

Device Installation

Follow the installation instructions provided in the user manual
to set up the Companion Mini Pro correctly.

Turning on/off the Device

To turn on the Companion Mini Pro, press the designated power
button. To turn it off, press and hold the power button until the
device shuts down.

Turning on/off the Pager

To activate the pager, press its power button. To turn it off,
follow the manufacturer’s instructions.

FAQ

Q: How often should I perform routine testing on the Companion

Mini Pro?

A: Routine testing should be conducted according to the
guidelines provided in the user manual, typically at regular
intervals to ensure proper functioning.

Q: Can I clean the device with water?

A: No, avoid using water to clean the device. Refer to the user
manual for recommended cleaning methods.

Companion Mini Pro
USER MANUAL

This document applies to;

P176A Product Version:

9

P176A Firmware:

v1.0

P176B Product Version:

9

P176B Firmware:

v1.0

P137 Product Version:

11

P137 Firmware:

v9.3

UH1462B-ENG Companion Mini Pro User Manual Version: 9.0.0 [31 May 2024]

LESS STRESS CARING

Congratulations on your Alert-iT purchase

2

Your product has been manufactured by a team of industry experts with more than 20 years of experience designing, manufacturing and distributing care alarms.
With a commitment to quality and innovation we are able to bring you a robust and reliable system to aid carers and the safeguarding of individuals.
Please read this quick start guide carefully to ensure the correct set up, use, and maintenance of your new product for years to come.
If you have any questions or require assistance in regards to the Companion Mini Pro or any other Alert-iT product please contact your equipment provider.
For equipment provided directly by Alert-iT, please call: +44 (0) 1530 239 900.

Contents

3

Intended Use

4

Safety

5

Safety Precautions

6

In The Box

7

Device Installation

8

Turning on the Companion Mini

8

Turning off the Companion Mini

8

Turning on the Pager

9

Turning off the Pager

9

Reset Button Setup

10

Fitting Reset Button

10

Positioning and Testing

11

Operation Overview

11

Companion Mini Function

12

System Operation

12

Alarm Mode

12

Pager Function

13

Pager Charging

13

Pairing Instructions

13

Maintenance Instructions for the Companion Mini

14

Routine Testing

14

How to Clean the Device

14

Changing Batteries in the Companinon Mini

14

Additional Information

15

Warranty Information

15

Routine Test Record Sheets

16

Profile Editor Software

18

Changing Settings on the Companion Mini

18

Using Profile Editor

18

Specifications

19

Intended Use

4

This product has been designed to discreetly monitor the user with high performance sensors which detects fine movements. The carer is then alerted via Alert-iT’s failsafe “Safelink®” radio system.
Indications for Use The product is intended to detect an increase in repetitive movement in the bed and to alert caregivers to the increased movement which may indicate a seizure. The Companion Mini is intended to be used when the individual is in bed either during the night or during the day.
Intended Users and Use Environment The product is intended to be used as an aid to caregivers. The user may be a layperson or healthcare professional. The product is intended to be used in a variety of settings, including home and professional settings.
Intended Patient Population The product is intended for use with individuals over 3 years old who may require monitoring whilst in bed.
Contraindications – The product does not provide information for diagnosis. – The product does not recommend any treatment or intervention. – The product may only be used with suitable paired devices.
Device Lifetime
The typical expected life of the product in normal home use is 5 years. Replace the product after this or earlier, if; – otherwise instructed; or – if any damage to the device is observed. See page 19 for recycling guidance. If any cracks or structural damage is observed, cease the use and replace the product immediately.
Note: the batteries must be replaced when the product does not start or if the receiving equipment indicates the battery is low.

Safety

5

Explanation of the markings used on the device and in the documentation

MD UDI LOT SN REF EC REP
IP20
RoHS

This is a Medical Device. Unique Device Identification. Batch Code. Serial Number. Catalogue Number. Manufacturer. Date of Manufacture. Authorized representative in the European Community. Keep Dry. Fragile, handle with care. Protected against solid objects over 12.5 mm (e.g. a finger) and no protection against liquids. Caution – Read the safety precautions before use. Refer to instructions for use. CE Mark. (the product conforms with the essential requirements of the Medical Device Regulations (EU) 2017/745). Symbol of the European Waste Electrical and Electronic Equipment Directive (WEEE Directive) 2002/96/EC on waste electrical and electronic equipment. Indicates that the product is in compliance with the European directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (commonly referred to as the Restriction of Hazardous Substances Directive or RoHS). Indicates positioning of battery cell. + is positive terminal and – is negative terminal.

Serious Incidents Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state of the European Union/country in which the user and/or patient is established. `Serious Incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following;
o the death of a patient, user or other person. o the temporary or permanent serious deterioration of a patient’s, user’s or other per-
son’s state of health. o a serious public health threat. Manufacturer’s contact information can be found on the back page of this document.

Safety Precautions

6

This symbol indicates there are warnings and precautions associated with the use of this equipment. This instruction manual should be carefully read and understood before using the equipment.

1. This device is designed only to be used as an aid for a caregiver.
2. The caregiver must never clear an alarm without checking the patient’s condition.
3. Ensure the pager power cable is routed to avoid a trip hazard.
4. Ensure, by testing, that the alarm notifications are received at the caregivers location(s).
5. A risk assessment must be conducted to determine if the level of reliability offered by the device is sufficient or if additional equipment is needed. Consideration shall be given to the patients likelihood of tampering with the system.
6. Clean and disinfect each item as needed in accordance with information on page 14.
7. Regularly test device as described in these instructions for use.
8. The device is not diagnostic and cannot differentiate between a tonic- clonic seizure and other repetitive movements.
9. Use only the accessories approved for use with this product and only in accordance with instructions.
10. Do not use this device for any purpose other than that specified by the manufacturer.
11. Operate power supply away from direct heat and uncovered.
12. Do not let the device get wet.
13. This product is for indoor use only in a dry environment.

14. Some accessories are fitted with small screws and have plastic bags. Ensure these do not come into the possession of vulnerable people who might choke on them.
15. Do not try to repair the device yourself.
16. No maintenance of the device is allowed during use.
17. If the equipment is modified in any way, appropriate inspection and testing must be conducted to ensure continue safe use of the equipment.
18. Remove the batteries when the device is not in use or when it is stored for an extended period. Alkaline batteries may become self-discharged, start leaking and contaminate the device.
19. Do not use any rechargeable batteries or lithium-ion batteries. Lithium- ion batteries carry the risk of over heating and ruining the device.
20. As with all electronic equipment there is potential for the equipment to interfere with or be effected by interference from other electrical or electronic devices. For this reason avoid placing the device, pager or charging cable in close proximity to sensitive electronic devices or devices which produce strong electromagnetic fields such as radio transmitters, mobile phones or power cables.
21. Regularly check the power supplies for damage and potential shock risks.
22. Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

The Alert-iT system has been designed with due regard to reliability and integrity. While it offers a highly vigilant monitoring method, it is always possible that a distress condition can go undetected for a variety of reasons (including malfunction) and in life threatening situations it is advisable to use the Alert-iT system in conjunction with additional monitoring techniques (e.g. video). Neither the manufacturer nor its agent can accept legal responsibility to provide a
system that is infallible. The carer is responsible for assessing the risks of using this equipment and any settings pertaining to it.

In The Box

7

The Companion Mini Pack Contains:

A 1 x Companion Mini – [P176A – C1] Includes 2x AAA 1.5V Alkaline Batteries (LR03. Non-rechargeable)

B 1 x Reset Button – [P176B]

Includes 2x AAA 1.5V Alkaline Batteries (LR03. Non-rechargeable)

C 4 x Velcro Pads

To secure the Companion Mini to the bed / foam

D 1 x Foam Block

Fitted under the mini to increase sensitivity

E 1 x Reset Button Wall Mount Kit

Includes: 2x Sticky Pads, 2x Wall Screws [Not shown]

A

B

C

D

Device Installation

8

This handbook covers everything you need to know to install, test and maintain the Companion Mini. The Companion Mini is designed to be fitted and used in 4 steps: Step 1) Turn on the Companion Mini (see below). Step 2) Turn on the Pager (see page 9). Step 3) Fit the Reset Button (see page 10). Step 4) Positioning and Testing (see page 11). Step 5) Using the Companion Mini (see page 12).
Turning on the Companion Mini
The Companion Mini monitor is supplied with batteries fitted but needs to be turned on before use.
To activate the Companion Mini, press and release the recessed ” ” button on the front of the monitor using a pen tip or similar tool [See figure 1].
The green light will illuminate briefly to indicate the unit is turned on. The Companion Mini is now ready to be positioned under the mattress.
Turning off the Companion Mini

Figure 1

If the Companion Mini is no longer needed it can be turned off by press and holding the ” ” button for 8 seconds.
Release the button and the light will flash red rapidly for several seconds upon shutting down.
The Companion Mini will send an “Monitor Off” fault notification to the pager upon shutting down.

PLEASE NOTE:
After turning the Companion Mini off, any device that it is paired with will now raise an “RF Fail” alarm after 2 minutes. This is due to the devices no longer receiving the regular radio Safelink signals from the Companion Mini that they are expecting. To stop the warning the mini will need to be unpaired or deactivated on the pager.

Turning on the Pager (Supplied Separately)
To the Pager on, press and hold the “Menu ” / “ON/OFF” button for 3 seconds. The pager will beep and the screen will show the pager software version information briefly before turning on. o If the Companion Mini is turned on, you now see the name
allocated to the Companion Mini flash on the screen every time the Companion Mini transmits its failsafe Safelink heartbeat signal.

9
PLEASE NOTE: While the pager is shipped with some charge in the batteries, it is recommended that the pager is charged before use. For full details about this pager see : UH1068B P137 User Manual

Mute

Alarm

On / Off

Figure 2
Turning off the Pager

To the pager off, press and hold the “Menu ” / “ON/ OFF” button for 3 seconds to enter the “Set-up & edit” menu. Use the right key to scroll to the menu item “Turn Off”.Press the up key to select “Turn off” and the pager
will turn off.

PLEASE NOTE:
It is recommended that you change Extended User Mode to Off.
“Setup & Edit” menu > Functions > UserExt = Off
This will hide the “Reset All” & “Turn Off” function behind the password.
This will prevent a carer from clearing an alarm on the pager and ensure they attend locally and press the P176B reset button.
See pager user manual for further details.

10 Reset Button Setup
The Reset Button is designed to allow the caregiver to reset the Companion Mini’s movement alarm on the pager once they have attended to the patient. Alert-iT advise that the Reset Button is located as near to the Companion mini as possible and is fixed in location using the provided screws or sticky pads. When the Reset Button is pressed, the movement alarm from the Companion Mini will clear instantly from all pagers. Please note: If the Companion Mini is still detecting repetative movements it will continue to send the alarm call and the pagers will re-alarm. The reset button is powered by 2x AAA 1.5V Alkaline batteries and should be replaced when Reset Buttons status light begins to flash red.
Fitting of Reset Button
Suggested placement of supplied sticky pads is shown in the photos above. The tabs can be tucked inside the case before fastening the back into place. This will stop the tabs from protruding out of the sides once fitted into position.

11
Positioning and Testing
The Companion Mini performs best if placed under the mattress, beneath the patients usual torso area. However, due to the wide variety of bed types and mattresses, it is advisable to test the device as per the instructions below. Step 1) Place the Companion Mini under the mattress on the base of the bed frame, in a central location underneath the torso area. Step 2) Test the devices operation by simulating the movement that needs to be detected on the bed and ensure the alarm is raised. Note 1: If the Companion Mini is struggling to detect the repetitive movements, the provided foam block can be used to increase the devices sensitivity. The foam is intended to be placed underneath the Companion Mini. Note 2: To improve alarm detection or to reduce false alarms, the Companion Mini’s alarm parameters can be adjusted using the Alert-iT Profile Editor software which is available to download for free (See page 18). If the device is now operating as expected, the Companion Mini can be secured to the bed frame using the provided velcro pads.
Operation Overview

The Companion Mini will raise an alarm notification upon detection of repetitive movements larger than the “Movement Level” setting that continue for longer than the “Movement Duration” setting. If there is a gap in the repetitive movements for longer than the “Movement Rate” setting, the duration counter will reset.

These 3 alarm parameters are adjustable via the Alert-iT Profile Editor software (see page 18):

– Movement Level.

(How sensitive the device is to movements)

– Movement Duration.

(The duration the repetitive movements need to continue for)

– Movement Rate.

(The gaps between individual jerking movements)

Once an alarm has been triggered, further alarms are inhibited for 2 minutes after the repetitive movements cease. This period is also adjustable, see “Suspend Duration” in the profile editor.

Companion Mini Function

12

System Operation
You should now have the Companion Mini installed in the bed, and the pager turned on and receiving the Safelink® signals. Indicated by the name assigned to the Companion Mini appearing on the pager screen every ~10 seconds. If the pager stops receiving the failsafe radio signal from the Companion Mini, the pager will raise a radio failure fault and will display “RF Fail” on the screen and an intermittent “Fault” tone will sound (if not disabled). If the Companion Mini’s battery gets “low” the pager will display “Fault 16”, to indicate that you should now change the battery in the Companion Mini. (see page 14), when the batteries get “very low” the pager will display “Batt-End” and the Companion Mini batteries should be changed immediately.
Alarm Mode
When repetitive movements are detected, the pager will audibly alarm and vibrate, the pager screen will display “Urgent 20” and the red “Alarm” light will illuminate. Pressing the “Sel” / “Up” button will temporarily mute the alarm tone and stop the pager vibrating for 5 minutes. Pressing the “Reset” button on the Reset Button will clear the alarm.

SAFETY NOTICE: The Companion Mini will continue to send the alarm notification until the repetitive movements have stopped.
Once the repetative movements stop, further movement alarms are inhibited for 2 minutes to prevent repeated alarms.
The alarm will remain on the pager until the “Reset” button is pressed on the Reset Button.
You MUST always check the user.

Pager Function

13

Pager Charging
The pager’s battery should last approximately 3 days depending on how many alarm cycles it goes through during this period. When the pager’s battery starts to get low it will indicate less than 10% charging remaining. When nearly exhausted it will indicate immediate charging is needed and an intermittent audible alarm will start. Charge for at least 12 hours. Please Note: The pager MUST be turned on whilst on charge. Turning the pager off will extend the charging time.
Pairing Instructions
The Companion Mini will usually be paired to the pager before it is shipped to you. If you should ever need to pair the items again, please follow the instructions below: Step 1) Ensure the monitor is turned on. Step 2) Set the pager into “Auto-Add” mode. This is done by pressing the menu button for 3 seconds to enter the “setup & edit” menu. Scroll right using the right arrow until a password is asked for “Pass=0000”, enter the password “1900” by using the up/down buttons to change the selected number and the right key to select the next digit. The left key is used to accept and confirm the entered password. Now scroll right to “AutoAdd” and select with the up key, then the left key to confirm. Within 10 seconds the pager should bleep and drop out of auto-add, offering a default name for the monitor, which is edited in the same way as the password, this time letters & blank are also available for the name.

Maintenance Instructions for the Companion mini 14
Routine Testing
It is recommended to test the system weekly by simulating the repetitive movements that you want the device to detect on the bed and ensuring the alarm is raised and received by the pager. A “Routine Testing” record sheet is provided on page 16.
How to Clean the Devices
It is recommended to clean the devices as needed by wiping with cotton wool pads moistened (compressed until dripping stops) with a mild detergent (0.5% washing up liquid) solution or by using an alcohol or baby wipe. Avoid getting any liquid into the micro-USB connector.
Changing Batteries in the CompanionMini or Reset Button
Step 1) Remove the back of the Companion Mini / Reset Button by inserting a small tool into the slot to depress the catch and release the case back (see figure 3). Step 2) Remove the old batteries and dispose of them appropriately. Step 3) Observe the polarity markings on the base of the case (see figure 4). Step 4) Insert the new batteries (see figure 5). Note: 2x AAA Alkaline 1.5V (LR03. Non-rechargeable). Step 5) Clip the rear case back into position. Step 6) After changing batteries, the Companion Mini will be turned on, replace the device under the mattress and test the device.

Figure 3

Figure 4

Figure 5

Additional Information

15

Warranty Information

For 3 years from the date of purchase of the initial equipment (excluding batteries), Alert-iT will offer you;
o Access to support between the hours of 9.00am and 5.00pm each weekday (excluding Public Holidays) via the telephone help-line for the purposes of fault diagnosis and the provision of advice.
o Repair (or if this is not possible-replacement) of faulty equipment free of charge, however, the equipment must be returned to Alert-iT at your own expense.
o After inspection by Alert-iT, any equipment that is deemed to have been damaged, rather than failing due to a technical fault will only be repaired after you have agreed to being invoiced for the cost of repairs and delivery.
o This agreement will terminate 3 years after the initial date of purchase, regardless of any new equipment being issued in the interim period.
Please note that liquid ingress voids warranty.

Routine Testing Record Sheet

Serial Number:
Test
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Signature

16
Date

Routine Testing Record Sheet

Serial Number:
Test
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Signature

17
Date

Profile Editor Software

18

Changing Settings on the Companion Mini

All Companion Mini’s are supplied with the following default settings;

o Movement Level = 3.

Available Adjustments:

3 = Most Sensitive. 9 = Least Sensitive

o Movement Duration = 15 seconds.

Available Adjustments: 8s to 35s.

o Movement Rate = 3 seconds.

Available Adjustments: 1s to 6s.

If required, these settings can be adjusted using the Alert-iT Profile Editor software which is available to download for free from our Support page; www .alert-it.co.uk/support

Installation instructions are available within the download.

A USB lead is provided to connect between the Companion Mini and your Computer.

Using Profile editor

Step 1) Connect the Companion Mini to the PC using the provided USB cable. The light will start flashing rapidly green. Step 2) Open the “Alert-iT Profile Editor”, click “Connect New Device”. Step 3) Click on “Movement Settings”. Step 4) Make any desired settings changes. Click “Save to device”.
The following icon will be found on your computer desktop after profile editor has been installed.

Specifications

19

Companion Mini

Reset Button

Model:

P176A

Model:

P176B

Connections:

micro-USB Type B (Programing only) Connections:

micro-USB Type B (Programing only)

Weight:

80g

Weight:

80g

Material:

White ABS Anti-microbial

Material:

White ABS Anti-microbial

Dimensions (mm): 100 x 44 x 16 (HxWxD)

Dimensions (mm): 100 x 44 x 16 (HxWxD)

Batteries:

2x AAA 1.5V Alkaline (LR03)

Batteries:

2x AAA 1.5V Alkaline (LR03)

Battery Life:

12 months

Battery Life:

3 years

Radio Frequency: 434.075MHz (P176*A)

Radio Frequency: 434.075MHz (P176*A)

Radio Frequency: 869.2125MHz (P176*B)

Radio Frequency: 869.2125MHz (P176*B)

Radio Power:

<10mW

Radio Power:

<10mW

Radio Range:

450m (Line-of-sight)

Radio Range:

450m (Line-of-sight)

Service Life:

5 years

Service Life:

5 years

Sealing:

IP20 (not waterproof)

Sealing:

IP20 (not waterproof)

Operating Temp: 5°C to 35°C (Used Indoors)

Operating Temp: 5°C to 35°C (Used Indoors)

Humidity Limit: 5% to 90% max. Non-condensing. Humidity Limit: 5% to 90% max. Non-condensing.

Storage Temp:

-30°C to 50°C

Storage Temp:

-30°C to 50°C

Certification

The manufacturer, iTs Designs Ltd., hereby declares that the Companion Mini conforms with the relevant requirements of the Medical Device Regulations (EU) 2017/745.
The manufacturer, iTs Designs Ltd., hereby declares that this product is in compliance with the Radio Equipment Regulations (UK) 2017 and the Radio Equipment Directive (2014/53/EU).
The full text of the EU declaration of conformity is available at the following internet address; www.alert-it.co.uk/support/
In conformity with the Waste Electrical and Electronic Equipment Directive (WEEE Directive), the device must be collected separately and returned to an authorised collection facility. The owner must take the device to the waste collection point specified by local authorities.

For more information on how to dispose of the device, please contact the relevant authorities.

EC REP

iTs Designs Ltd T/A: Alert-iT Care Alarms Fernie House, Unit 3 Coalville Business Park Jackson Street Leicester, UK. LE67 3NR
Leisner ApS Korsvangcentret DK – 5610 Assens Denmark
For support please contact your equipment provider.

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