Gyenno Technologies MS100-IFU Parkinson Disease Sleep Assessment System User Manual

User Manuals
Parkinson’s Disease Sleep Assessment System

MS100-IFU-EN V1.1
Version number
V1.0 V1.1

Revision History

Version number| Reason for revision and content| Date of revision| Revisionist
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V1.0| New Release| 2022-03-01| Xiaoyun Liu
V1.1| Added FCC ID content| 2022-04-20| Xiaoyun Liu
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Description of terms in this manual

Warning| ** Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
---|---
Caution| ** Indicates a potentially hazardous situation that, if not avoided, may result in invalid data collecting, damage to the equipment or invalid operation.
Attention| **** Information is necessary to be known before using the equipment.

Intended use

Parkinson’s Disease Sleep Assessment System (hereinafter referred to as “the device”) is used to quantitatively analyze and assess sleep quality, nocturnal symptoms and early morning motor symptoms, mainly for patients with Parkinson’s disease. For Parkinson’s disease patients.

Security Information

Warning

1. Do not place or store this equipment near an open flame or heat source.
2. Do not use broken power cords or outlets.
3. Patients with pacemakers or other electrical stimulation devices should not use this device.
4. Do not plug or unplug the power cord with wet hands. 5 Do not use the measurement results of this device as a basis for diagnosis.

Caution

1. This equipment must not be immersed in liquid outside the B side.
2. If you accidentally fall into the liquid (such as bedwetting and other situations) when using this equipment, please immediately unplug the power cord and promptly clean up the A-side.
3. The A-side of this equipment can be washed using a washing machine without high-temperature cooking.
4. Do not use this device in a strong magnetic field environment.
5. Do not exceed the maximum load of this equipment.
6. Do not disassemble or modify this equipment by yourself.

Overview

Introduction

The device collects the sleep data of Parkinson’s disease patients through the built-in sensor module and uploads the data through the wireless communication module. After further analysis and processing, the measurement results of sleep quality, nocturnal movement symptoms, and early morning movement symptoms can be obtained.

Composition

This device consists of side A, side B, a data box, and a 5V3A adapter.

Equipment front

P a r t|

D e sc r i p t i o n

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1| A side screen printing “GYENNO”
2| A side screen printing  ****
3| Built-in memory foam on Aside
4| A-side silkscreened sit down icon
5| B-side data cable and data box connection

Table 1 Equipment front

Data Box Description

P a r t

|

D esc r i p t i on

---|---
1| 5V3A adapter
2| Equipment Indicator

Table 2 Data Box Description

Working conditions

C ond i t i on s|

P a r a m e t e r s

---|---
Ambient temperature| 5 ℃ ~ +40 ℃
Relative Humidity| 10% ~ 85% RH (no condensation)
Atmospheric pressure| 70 kPa ~ 106 kPa
**** Supply Voltage| Internal power supply 3.7 V  900 mAh
External power supply 5V 3A

Table 3 Working conditions

Storage conditions

C ond i t i on s

|

P a r a m e t e r s

---|---
Ambient temperature| -20 ℃ ~ +50 ℃
Relative Humidity| 10% ~ 93% RH (no condensation)
Atmospheric pressure| 70 kPa ~ 106 kPa

Table 4 Storage conditions

Symbols used in this equipment

These symbols will be indicated in this operation manual where necessary to warn of potential hazards.

| Warning
---|---
| Caution
| Attention
| Refer to the user manual
| Waste Electrical and Electronic Equipment
| Type BF applied part
| DC
| Non-ionizing radiation
****| Authorized Representative in the European Community
| Medical device
---|---
| Manufacturer

Table 5 Symbols used in this equipment

Specifications and parameters

Terminology

Sleep efficiency: refers to the efficiency of the patient’s sleep detected by this device.
Total sleep time: The total time the patient sleeps as detected by this device.
Sleep latency: refers to the sleep latency of the patient detected by this device.
A number of night-time wake-ups: The number of night-time wake-ups of the patient detected by the device.
Sleep time point: The time point at which the patient falls asleep as detected by the device.
Wake-up time point: The time point at which the patient wakes up as detected by this device.
Wake-up time: The time consumed by the patient from waking up to waking up as detected by this device.
A number of wake-up attempts: The number of wake-up attempts detected by this device for the patient.
Concomitant tremor: This refers to whether a tremor occurs from the time the patient wakes up to the time they get up as detected by the device.

Specification

M a i n parameters

|

I nd i ca t o r s

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Overall size| 870 mm(L) 670 mm(W) 8 mm(D)
Overall weight| ≈500 g
Charging form| DC input
Maximum load capacity| 200kg
Wireless| Wireless Standards| 802.11 b/g/n
Frequency range| 2400 MHz ~ 2483.5 MHz
Antenna Type| Built-in antenna

Table 6 Specification parameters

Indicator light description

I nd i ca t o r color|

S t a t u s Description

---|---
Yellow is always on| Not connected
Always blue| Networked, no one on the mat
Blue Breath| Networked, someone on the mat
Red flashing| Equipment abnormalities
Indicator light is off| Shutdown

Table 7 Indicator light description

Instructions for use

Prepare for first-time use

This device needs to be used with the device mobile application – HYPNOS APP, Please download the “HYPNOS” APP from the following channels and install it, after completing the installation, according to the “HYPNOS” APP user guide to complete the registration.
This device needs to be used with the device mobile application ­ “HYPNOS”APP. Please search for “HYPNOS” in the appropriate mobile application store, download and install it. after completing the installation, according to the “HYPNOS” APP user guide to complete the registration.
Before using this device for the first time, you need to complete the binding and network configuration with the “HYPNOS” APP, please follow the user guide of mobile application “HYPNOS” APP to complete.
Cybersecurity
“HYPNOS” app software needs to use user name and password for user authentication, and can log in and view data only after passing the authentication; Verification failed, unable to log in and give a prompt. Ruihang app software needs to use user name and password for user authentication, and can log in and view data only after passing the authentication; Verification failed, and unable to log in and give a prompt.

When using

5.2.1 Mounting accessories

Tear the A-side and B-side Velcro, as shown in the figure below. The direction of the B-side data line out can be selected according to the left and right of the sleeping position. Glenn and alignment of side A and side B, fitting side A and side B
5.2.2 Placement of cushion bed
As shown in the picture below, please place the assembled device, under the sheet, with the top of the device flush with the shoulder.
5.2.3 Open and Close
Turn on: Insert the adapter into the data box, then connect the power supply and the device indicator lights up.
Turn off : Disconnect the adapter from the power supply and the device indicator goes off.

1. Adapter requirement: 5V 3A.
   Attention

2. Discarded equipment and power cords must be disposed of in accordance with local regulations or they may cause contamination.

 Equipment Monitoring

This device is turned on and the person lies down on the device to automatically start the detection.

Transferring data

The data recorded by the device is saved in the device and uploaded in bulk with the wireless network configured.

1. Turn the unit on before preparing to transfer data.
2. Wait for the network connection to be ready, the indicator light indicates blue and the waiting time is about 5minutes.

Figure 9 Device connected to a wireless network

View Results

The measurement results of this device can be viewed in the mobile application “HYPNOS” APP “Data”, including the data of sleep quality, nighttime symptoms, early morning movement symptoms, etc. by date.

Caution
If the corresponding measurement results cannot be viewed, it may be due to the following reasons.

1. After the measurement cycle is completed, no data is uploaded or the uploaded data is incomplete due to lack of wireless network connection or other reasons.
2. Leave the equipment while monitoring.

Cleaning equipment

Please take the A-side pad to wash separately, you can use the washing machine to wash.
Side B is not washable but can be wiped with a cloth dampened with water.

Maintenance and Care

• The B side of the equipment should not be immersed in water, please wipe it with a cloth with water.
• Turn off the equipment before disassembling it.
• Do not place or store this equipment near an open flame or heat source.
• This equipment contains motors and precision devices, long-term magnetic field interference will reduce product performance and affect the service life.
• Avoid dropping or impacting this equipment during use or storage.
• Do not fold the device or use sharp objects to press the device.
• This device is used for sleep detection and early morning motion detection, both in bed.

Troubleshooting

F a u l t Type| P o ss i b l e causes  and  treatment  methods
---|---
**F a il e d to  bind  the  mobile application| 1  . I n s u f f i c i e n t s i g n a l s t r e n g t h o f c e l l u l a r o r w i r e l e ss n e t w o r k s f o r mobile terminal please  move to a location with a stronger signal and try again.
2. The device has been tied by another user Please call customer service for a solution.
F a u l t Type| P o ss i b l e causes  and  treatment  methods
---|---
| 3  . The QR code is lost or broken and cannot be scanned
Please call customer service for a solution.
****F a il e d to  connect  to a wireless network| 1 . Enter the wrong wireless network password
Please enter the correct wireless network password and try again.
2 . Device exits fast connection due to timeout
Please try again following the section “ Connecting to the wireless network “.
3 I n s u f f i c i e n t s i g n a l s t r e n g t h o f the  w i r e l e ss n e t w o r k
Please move to a location with a stronger signal and try again.
****F a i l u r e to  transfer  data| 1 . The device is not bound to the mobile program
Please try again according to the section “ Binding the mobile application “.
2 . I n s u f f i c i e n t s i g n a l s t r e n g t h o f the  w i r e l e ss n e t w o r k
Please move to a location with a stronger signal and try again.
The device indicator  flashes red| Please call customer service for a solution.
O t h e r faults**| Please call customer service for a solution.

Precautions

This device has no sleep therapy function.

Contraindications

Do not use this device if you are allergic to polyester and spandex.

EMC information

Guidelines and Manufacturer’s Statement – Electromagnetic Emission

The device is expected to be used in the following prescribed electromagnetic environment, and the purchaser or user of the device should ensure that it is used in such an environment.
Launch test| Conformity| Electromagnetic Environment-Guide
Radio Frequency Emission GB 4824| 1 group| The device uses RF energy only for its internal functions. Therefore, its RF emissions are low and the potential for interference with nearby electronic devices is minimal.
Radio Frequency Emission GB| Class B| The device is suitable for use in all facilities, including domestic and residential
4824| | public low-voltage supply networks connected directly to the home.
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Harmonic emission GB 17625.1| Class A
Voltage fluctuation / flicker emission GB17625.2| ****

Conformity

Table 9 For all equipment and systems

Guidelines and Manufacturer’s Statement – Electromagnetic Immunity

the device is expected to be used in the following specified electromagnetic environment, and the purchaser or user of the device should ensure that it is used in such an electromagnetic environment.
Immunity test| IEC 60601 test level| Conformity level|

Electromagnetic Environment-Guide

Electrostatic discharge GB/T 17626.2| ±6 kV contact discharge
±8 kV Air discharge| ±6 kV contact discharge
±8 kV Air discharge| The floor should be wood, concrete or tile, and if the floor is covered with synthetic material, the relative humidity should be at least 30%
The electric fast transient pulse train
GB/T 17626.4| ±2kV to power line| ±2kV to power line| Net power should be of a quality typical of use in a commercial or hospital environment
Surge GB/T 17626.5| ±1 kV wire-to-wire
±2 kV line-to-ground|

±1 kV wire-to-wire
±2 kV line-to-ground

|

Net power should have qualities typical of use in a commercial or hospital environment

Voltage transients, short interruptions, and voltage variations on the power input line GB/T 17626.11| <5 % UT, for 0.5 cycles (on UT,>95% of the temporary drop)40 % UT, duration 5 cycles(on UT, 60% of temporary drop) 70 % UT, for 25 cycles (on UT, 30% temporary drop)<5 % UT, for 5s (on UT, >95% of temporary drop)| <5 % UT, for 0.5 cycles (on UT, >95% of temporary drop)40 % UT, duration 5 cycles(on UT, 60% temporary drop)70 % UT, for 25 cycles (on UT, 30% temporary drop)<5 % UT, for 5s (on UT, >95% of temporary drop)|

The network power supply should be of a quality typical of use in a commercial or hospital environment. Uninterruptible power supply or battery power is recommended for (equipment or system) if users of (equipment or system) require continuous operation during power interruptions

Industrial frequency magnetic field (50/60Hz) GB/T 17626.8| 3A/m| 3A/m| The FT magnetic field should have the FT magnetic field level characteristics typical of a site in a typical commercial or hospital environment
Note: UT refers to the AC network voltage before the test voltage is applied.

Table 10 For all equipment and systems

Guidelines and Manufacturer’s Statement – Electromagnetic Immunity

The device is expected to be used in the following specified electromagnetic environment, and the purchaser or user of the device shall ensure that it is used in such an electromagnetic environment.
Immunity test| IEC 60601 test level| Conformity level| Electromagnetic Environment-Guide
Radio Frequency Conduction GB/T 17626.6| 3 V( rms)

150 kHz ~ 80 MHz

| 3 V( RMS)| Portable and mobile RF communications equipment should not be used closer to any part of the (equipment or system), including cables, than the recommended isolation distance. This distance is calculated by the formula corresponding to the transmitter frequency.
Recommended isolation distance d = 1.2
Radio Frequency Radiation GB/T 17626.3| 3V/m 80 MHz ~ 2.5 GHz| 3V/m| d = 1.2 80 MHz ~ 800 MHz
d = 2.3  800 MHz ~ 2.5 GHz
where :
P – the maximum rated output power of the transmitter, in watts (W), according to the transmitter manufacturer.
d – The recommended isolation distance in meters (m)b.
The field strength of the fixed RF transmitter is determined by the electromagnetic field house of Survey a to determine, in each frequency rangeb should be lower than the compliance level. Interference may occur in the vicinity of equipment marked with the
| | | following symbols.
Note 1: At 80 MHz and 800 MHz frequencies, the formula for the higher band is used.
Note 2: These guidelines may not be appropriate in all cases. Electromagnetic propagation is influenced by absorption and reflection from buildings, objects and the human body.
a.Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b.Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3V/m.
c. The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

Table 11 For non-life support equipment and systems

Recommended isolation distance between portable and mobile RF communication equipment and (equipment or system)

The device is expected to be used in an electromagnetic environment with controlled RF radiation harassment. Based on the maximum rated output power of the communication equipment, the purchaser or user of the device can prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communication

equipment (transmitters) and the device as recommended below.

The transmitter is rated for maximum High output power W| Isolation distance corresponding to different frequencies of the transmitter m
150 kHz ~ 80 MHz d = 1.2| 80 MHz ~ 800 MHz d = 1.2| 800 MHz ~ 2.5 GHz d = 2.3
0.01| 0.12| 0.12| 0.38
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
Note 1: At 80 MHz and 800 MHz frequencies, the formula for the higher band is used.
Note 2: These guidelines may not be appropriate in all cases. Electromagnetic propagation is influenced by absorption and reflection from buildings, objects, and the human body.
For transmitter maximum output power ratings not listed in the table above, the recommended isolation distanced, in meters (m), can be determined using the formula in the corresponding transmitter frequency column, where P is the maximum transmitter output power rating in watts (W) provided by the transmitter manufacturer.
Note 1: At the 80 MHz and 800 MHz frequency points, the formula for the higher frequency band is used.
Note 2: These guidelines may not be appropriate in all cases. Electromagnetic propagation is influenced by absorption and reflection from buildings, objects, and the human body.

Regulatory Information

FCC ID: 2ACGF-MS00A This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a rental installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
— Reorient or relocate the receiving antenna.
— Increase the separation between the equipment and receiver.
— Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
— Consult the dealer or an experienced radio/TV technician for help.
NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. such modifications could void the user’s authority to operate this equipment.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
This device complies with Industry Canada RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Specific Absorption Rate (SAR) information
This Hand Tremor Data Collector meets the government’s requirements for exposure to radio waves. The guidelines are based on standards that were developed by independent scientific organizations through periodic and thorough evaluations of scientific studies. The standards include a substantial safety margin designed to assure the safety of all persons regardless of age or health.
FCC RF Radiation Exposure Statement:

1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.
3. This equipment should be installed and operated with a minimum distance of 20cm between the radiator& your body.

Quality Commitment

The equipment comes with an 1annual warranty. (hereinafter referred to as “the Company”) is not responsible for direct, indirect, or final damage and delays caused by.

• Equipment is disassembled or modified
• Repair or modification of equipment by persons not authorized by the Company
• Damage caused by abnormal use beyond the specified conditions of use
• Manufacturing logo replacement or removal
• Improper use of operation

Disposal in case of disposal

GLENN has always been committed to caring for the global environment and reducing the environmental load, and we hope that local citizens will also do their part in environmental protection activities, especially in the disposal of waste in general.

• In order to recycle the unused packaging materials, please deliver them to the relevant local recycling companies for disposal.
• Disposal of discarded consumables or parts shall comply with the relevant laws and regulations, and please dispose of them appropriately in accordance with the relevant laws and regulations.
• When the product is disposed of, please dispose of it as electronic waste.

Copyright and Responsibility

The copyrights and confidentiality of this manual are owned by GLENN.
This manual is subjected to be a reference for operating and maintaining the equipment.

Manufacturer: GYENNO Technologies CO., LTD.
Address: A805 A806, Shenzhen Institute of Industry-University-Research of HUST, No.9
Yuexing 3rd Road, Science Park, Nanshan District, Shenzhen,518000, P.R.China
Tel.: 0086-755-86724035
Email: service@gyenno.com
Website: www.gyenno.com

References

• GYENNO 官网

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