P176A Companion Mini Plesio Pager Handbook

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Product Information

Specifications

• Product Name: Companion Mini

• Product Version: P176A (9), P168 (1)

• Firmware Version: P176A v1.0, P168 v4.0

• User Manual Version: UH1462A-ENG Companion Mini User Manual
  Version 12.0.0 [24 May 2024]

• Intended Use: Detect an increase in repetitive movement in the
  bed to alert caregivers, suitable for individuals over 3 years
  old.

• Expected Lifetime: 5 years under normal home use

Product Usage Instructions

Device Installation

Follow the provided installation guide to set up the Companion
Mini correctly.

Turning on/off the Companion Mini

Press the power button to turn on/off the Companion Mini.

Turning on/off the Pager

To turn on/off the Pager, press the respective power button.

Positioning and Testing

Place the Companion Mini in the desired position and perform
testing to ensure proper functionality.

Maintenance Instructions

• Routine Testing: Regularly test the device to ensure it is
  functioning correctly.

• Cleaning: Follow the provided instructions to clean the device
  properly.

• Battery Replacement: Change batteries when the device fails to
  start or when indicated by low battery warnings.

FAQ

Q: What is the intended use of the Companion Mini?

A: The Companion Mini is designed to detect repetitive movement
in bed to alert caregivers, suitable for individuals over 3 years
old.

Q: How long is the expected lifetime of the Companion

Mini?

A: The typical expected life under normal home use is 5 years.
Replace earlier if damage is observed or instructed otherwise.

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Companion Mini
USER MANUAL

This document applies to;

P176A Product Version:

9

P176A Firmware:

v1.0

P168 Product Version:

1

P168 Firmware:

v4.0

UH1462A-ENG Companion Mini User Manual Version: 12.0.0 [24 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 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

Positioning and Testing

10

Operation Overview

10

Companion Mini Function

11

System Operation

11

Alarm Mode

11

Operational Tables

12

Pager Function

14

Pager Charging

14

Pairing Instructions

14

Un-Pairing Instructions

14

Maintenance Instructions for the Companion Mini

15

Routine Testing

15

How to Clean the Device

15

Changing Batteries in the Companinon Mini

15

Warranty Information

16

Routine Test Record Sheet

17

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 15.
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]

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

B 1 x Plesio Pager – [P168]

C 4 x Velcro Pads

D 1 x Foam Block

Fitted under the mini to improve sensitivity

E 1 x micro-USB Cable

Used to change alarm settings

F 1 x 9v Pager Power Supply – [P153] [Not shown]

A

B

C

D

E

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) Positioning and testing (see page 10). Step 4) Using the Companion Mini (see page 11).

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.

Turning on the Pager
To turn the Pager on, press and hold the ” ” button for 3 seconds, the pager will beep and all three LEDs will flash once. o The green “Pager” light will flash every 8 seconds to show that the
pager is awake and listening for alarm signals. o If the green “Pager” light flashes rapidly, the pager requires
charging (see page 14). o If the Companion Mini is turned on, you will now see the red
“Monitor” light on the pager flash every time it receives the Safelink radio signal from the mini.
Pair / Mute
Monitor Light

9
PLEASE NOTE: While the pager is shipped with some charge in the batteries, it is recommended that the pager is charged before use (See page 14). The pager MUST be turned on whilst on charge. Turning the pager off will extend the charging time.
Alarm Light
Pager Light

On / Off

Turning off the Pager
To turn the pager off, press and hold the ” ” button for 3 seconds. The pager will bleep and all three lights will flash 3 times.

Figure 2
PLEASE NOTE: If a pager cannot detect its paired monitor, it will raise a “fault” alarm (see page 12). This is due to the pager not receiving the regular failsafe Safelink heartbeat radio signals from the Companion Mini. To stop the fault warning, check the Companion Mini is turned on and test it. If the Companion Mini is no longer required, it will need to be un-paired from the pager (see page 14).

10
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. 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

11

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 red “Monitor” light flashing on the pager each time one is received. If the pager stops receiving the failsafe radio signal from the Companion Mini, the pager’s “Monitor” light will be permanently lit and an intermittent “Fault” tone will sound. If the Companion Mini’s battery gets low the pager’s “Monitor” light will flash every second, to indicate that you should now change the battery in the Companion Mini. (see page 15).
Alarm Mode
When repetitive movements are detected, the pager will audibly alarm, vibrate and the red “Alarm” light will illuminate. Pressing the “Pair/Mute” button will temporarily mute the alarm tone and stop the pager vibrating for 5 minutes. 60 seconds after the repetitive movements have stopped, the pagers audible alarm tone will resume, pressing the “Pair/Mute” button again will clear the pager (If previously muted, this will be the second press).
SAFETY NOTICE: The Companion Mini will continue to send the alarm notification until the repetitive movements have stopped for 1 minute. After 1 minute, the Companion Mini will send the “All Clear” signal. Upon receiving the “All Clear” signal, the pager will remain in its alarm state until the “Pair/Mute” button is pressed. You MUST always check the user even if the alarm appears to have cleared.

12

The tables below give an indication of the status of the Alert-iT devices based on Light, Sound and Vibration condition(s).

Operational Modes of the Plesio Pager

STATUS

Vibration

Beeping/ Tone

“Pager” Light (Green)

“Monitor” Light “Alarm” Light

(Red)

(Red)

Stops receiving failsafe radio from Companion Mini

No

Du-Di-Du Tone every minute

N/A

Solid (Permanently lit)

N/A

Alarm mode with ongoing movement

Yes

Ongoing alarm tone

N/A

Flash every Second

Solid (Permanently lit)

Muted Alarm Mode with ongoing movement

No

No

N/A

Flash every Second

Solid (Permanently lit)

Alarm mode with movement stopped – Pair to clear

Yes

Ongoing alarm tone

N/A

Blips On

Solid (Permanently lit)

Companion Mini battery getting low

No

No

N/A

Flash every Second

N/A

On and paired to Minilistening for alarm signals

No

No

N/A

Blips On

N/A

Switching Off

No

Switching On

No

Pager battery getting low

No

Pager battery getting very low

No

Pager – Boost Charge Mode

No

Pager Trickle Charging

No

On (battery power only)

No

Off

No

Three Beeps

3 Flashes

Once

Flash Once

No

Flash every Second

Sound every minute

Flash every Second

No

Solid with blipping off

No

Solid (Permanently lit)

No

Blips On

No

N/A

3 Flashes Flash Once
N/A
N/A
N/A N/A N/A N/A

3 Flashes Flash Once
N/A
N/A
N/A N/A N/A N/A

13

Test Mode – i.e. for positioning and setup

Action

Pagers Audible Sounder

Pagers “Pager” Light
(Green)

Pagers “Monitor” Light (Red)

Pagers “Alarm” Light
(Red)

Companion Mini`s “Alarm” Light

Button pressed on Companion Mini

N/A

N/A

N/A

N/A

Flashing Green

Movement Detected

Du-Di-Du Tone

N/A

Flashes 3 times

Illuminates Red for

N/A

Movement Rate period

(Permanently lit)

Pairing/Clearing a Monitor to the Plesio Pager

Action Pairing: Pair successful

Pagers Audible Sounder
Beeps Once

Pagers “Pager” Light
(Green)
N/A

Pagers “Monitor” Light (Red)
Once

Pagers “Alarm” Light (Red)
N/A

Clearing Paired devices

Multiple beeps followed by single
beep

Flashes once at single Beep

Solid until single Beep

N/A

Pager Function

14

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 the green “Pager” light (Figure 2) will start to flash green every second indicating the pager should be plugged into the provided charger. When the pager’s battery is very low, the pager will start making an audible “Fault” sound every minute. When charging, the green “Pager” light will blip off every 8 seconds during boost charge, then will turn solid green when the battery is approaching full charge. 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) Turn the pager off, then back on again (Pairing is only possible within 30 seconds of powering up the pager). Step 2) Place the monitor close to the pager (Pairing is restricted to nearby devices). Step 3) Press and hold the “Pair/Mute” button on the pager. Step 4) While still holding the “Pair/Mute” button. Stimulate any radio transmission from the Companion Mini (press the ” ” button, trigger an alarm, or just wait for the regular safelink signal every ~12 seconds). If successful, you will hear a beep sound and see the pagers “Monitor” light flash red. A lower “burp” sound with no red light flash indicates the monitor is too far away to pair (This protects against pairing with another distant monitor).
Un-Pairing Instructions
Note: It is not possible to un-pair a single monitor using this method, you can only clear everything. Step 1) Turn the pager off, then back on again (Un- pairing is only possible within 30 seconds of powering up the pager). Step 2) Press and hold the “Mute/Pair” button and the ” ” button on the pager together until the ensuing tone has finished and the pagers “Pager” light flashes green.
Step 3) Release both buttons. The pagers paired monitor memory is now empty.

Maintenance Instructions for the Companion mini 15
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 17.
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 Companion Mini
Step 1) Remove the back of the Companion Mini 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

16
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

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

Plesio Pager

Companion Mini

Model:

P168

Power:

1.3mm 9V DC

Weight:

161g

Material:

White ABS Anti-microbial

Dimensions (mm): 120 x 70 x 20 (HxWxD)

Batteries:

2x AA Ni-MH 1.2V (HR6. Rechargeable) 2400mAh

Battery Life:

80 hours (100 typical)

Charging Time: 12 hours

Radio Frequency: 434.075MHz

Service Life:

5 years

Sealing:

IP52 (not waterproof)

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

Humidity Limit: 5% to 90% max.

Non-condensing.

Storage Temp:

-30°C to 50°C

Certification

Model:

P176A

Connections:

Micro USB Type-B (Programing only)

Weight:

80g

Material:

White ABS Anti-microbial

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

Batteries:

2x AAA 1.5V Alkaline (LR03)

Battery Life:

12 months

Radio Frequency: 434.075MHz (P176*A)

Radio Frequency: 869.2125MHz (P176*B)

Radio Power:

<10mW

Radio Range:

450m (Line-of-sight)

Service Life:

5 years

Sealing:

IP20 (not waterproof)

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

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

Storage Temp:

-30°C to 50°C

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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