Medic Coach 5575AQ - Health device REVITIVE - Free user manual and instructions

USER MANUAL Medic Coach 5575AQ REVITIVE

Guidance and Manufacturer's Declaration

Important information regarding Electromagnetic Compatibility (EMC)

With the increased number of electronic devices such as PC's and mobile (cellular) telephones, medical devices may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and could create a potentially unsafe situation.

In order to regulate the requirements for EMC, with the aim to prevent unsafe product situations, the IEC/EN 60601-1-2 and IEC/EN 60601-1-11 standards have been implemented. These standards define the levels of immunity to electromagnetic interference as well as the maximum levels of electromagnetic emissions for medical devices.

Revitive devices are intended for use in the home setting without the need for involvement of a clinical professional during treatment. On occasion the device may also be used in a hospital environment. In this environment use near the following equipment should be avoided:

• active High Frequency Surgical Equipment
- radio frequency shielded rooms for magnetic resonance imaging (where the intensity of Electro Magnetic Disturbances is high).

Warnings

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories and cables other than those specified or provided by Actegy Ltd for this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Wireless communications equipment such as wireless network devices, mobile phones, cordless telephones and their base stations can affect this equipment and should be used no closer than 30 cm (12 inches) to any part of the Revitive Circulation Booster, including cables specified by Actegy Ltd. Otherwise, degradation of the performance of this equipment could result.
• No modification of the Revitive device or equipment is allowed
• Connection to high frequency surgical equipment whilst using Revitive may result in electrode burns and possible damage to the device. Operation in close proximity (e.g. 1m) to shortwave or microwave therapy may produce instability in the device output

Guidance and Manufacturer's Declaration

- Contains FCC ID: A8TBM70ABCDEFGH

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.

Federal Communication Commission Interference Statement

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 residential 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 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.

FCC Caution

Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment.

IC Statement

This Class B digital apparatus complies with Canadian ICES-003.

This device complies with Industry Canada license-exempt 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.

Guidance and Manufacturer's Declaration

This radio transmitter (identify the device by certification number or model number if Category II) has been approved by Industry Canada to operate with the antenna types listed below with the maximum permissible gain indicated. Antenna types not included in this list, having a gain greater than the maximum gain indicated for that type, are strictly prohibited for use with this device.

IMPORTANT NOTE:

FCC Radiation Exposure Statement

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.

This device and its antenna(s) must not be co-located or operation in conjunction with any other antenna or transmitter.

IC Radiation Exposure Statement

This device is in compliance with SAR for general population/uncontrolled exposure limits in IC RSS-102 and has been tested in accordance with the measurement methods and procedures specified in IEEE 1528.

The device and its antenna must not be co-located or operated in conjunction with any other antenna or transmitter.

This module is intended for OEM integrator. The OEM integrator is still responsible for the IC compliance requirement of the end product, which integrates this module.

20cm minimum distance has to be able to be maintained between the antenna and the users for the host this module is integrated into. Under such configuration, the IC RSS-102 radiation exposure limits set forth for an population/uncontrolled environment can be satisfied.

Guidance and Manufacturer's Declaration

Electromagnetic Compatibility Information

Phenomenon	Basic EMC standard or test method	Test level/requirement
Mains terminal disturbance voltage	CISPR11EN 55011	Group 1, Class B
Radiated disturbance	CISPR11EN 55011	Group 1, Class B
Harmonic Current Emission	IEC 61000-3-2EN 61000-3-2	Class A
Voltage change, voltage fluctuations and Flicker Emission	IEC 61000-3-3EN 61000-3-3	Pst: 1Plt: 0.65Tmax: 0.5Dmax: 4%Dc: 3.3%
Electrostatic Discharge Immunity	IEC 61000-4-2EN 61000-4-2	±8 kV/Contact±2, ±4, ±8, ±15 kV/Air
Radiated RF Electromagnetic Field Immunity	IEC 61000-4-3EN 61000-4-3	10V/m80 MHz - 2.7 GHz80% AM at 1 kHz
Immunity to Proximity Fields from RF wireless Communications Equipment	IEC 61000-4-3EN 61000-4-3	Table 9 inIEC 60601-1-2:2014
Electrical Fast Transient/Burst Immunity	IEC 61000-4-4EN 61000-4-4	±2kV. 100 kHzRepartition frequency
Surge Immunity	IEC 61000-4-5EN 61000-4-5	Line to Line±0.5kV, ±1kV
Immunity to Conducted Disturbances induced by RF fields	IEC 61000-4-6EN 61000-4-6	3V0.15 MHz - 80MHz6V in ISM and amateur radio bands between 0.15 MHz and 80 MHz80% AM at 1 KHz
Power Frequency Magnetic Field Immunity	IEC 61000-4-8EN 61000-4-8	30 A/m50 Hz & 60 Hz
Voltage dips	IEC 61000-4-11EN 61000-4-11	0 % UT: 0.5 cycleAt 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315°
		0 % UT: 1 cycleand70% UT: 25/30 cyclesSingle phase: at 0°
Voltage Interruptions	IEC 61000-4-11EN 61000-4-11	0 % UT: 250/300 cycle

Guidance and Manufacturer's Declaration

Bluetooth Compliance Testing Table

Certification	Standards	Article	Laboratory	Report Number	Date
Safety EN 62368-1:2014+A11:2017		[3.1(a)]	TUV Rheinland Taiwan 2017	10051261 004 2020-07	-30
Health	EN 300 328 V1.9.1/ EN 62479:2010			10051261 004 2015-12	-10
EMC	EN 301 489-1 V2.1.1EN 301 489-1 V2.2.3*	[3.1(b)] 1005197003 2017		-05-26
	EN 301 489-17 V3.1.1EN 301 489-17 V3.2.0
Radio EN 300 328 V2.2.2 (3.2)				NN20VXHG(EN300328-BLE) 001	2020-08-25

Supplier's Declaration of Conformity 47 CFR § 2.1077 Compliance Information
USA & Canada Only

Unique Identifier: Revitive Medic Coach (5575AQ)
Company Name: Actegy Health Inc.
Address:	Actegy Health Inc. 6400 Shafer Court, Suite 225, Rosemont, IL 60018, USA.
Telephone:	Tel: [phone]
Contact name:	Glenn Kowalski ([e-mail])

1 West Point, Western Road, Bracknell, RG12 1HJ, United Kingdom

Tel: [phone]

MDSS

Schiffgraben 41

30175 Hannover, Germany.

Country Distributors/Distributeur/Vertriebshändler/Distribuidores/Distributori :

UK:

Actegy Ltd

1 West Point, Western Road, Bracknell, RG12 1HJ.

Tel: [phone]

[e-mail]

AU:

Actegy Pty Ltd.

Unit 4 / 1 Newspaper Place,

Maroochydore,

QLD 4558.

Tel: [phone]

[e-mail]

CA:

Actegy Health Inc.

6400 Shafer Court,

Suite 225,

Rosemont, IL 60018, USA.

Tel: [phone]

NZ:

Actegy Ltd.

Level 1, 6 Johnsonville Road

Johnsonville,

Wellington 6037.

Tel: [phone]

[e-mail]

USA:

Actegy Health Inc.

6400 Shafer Court,

Suite 225,

Rosemont, IL 60018.

Tel: [phone]

DE/AT:

Actegy GmbH

Rankestr. 8

D-10789 Berlin

HRB 157353

Tel: [phone] (DE)

[phone] (AT)

[e-mail]

[e-mail]

FR/BE/IT/ES/NL:

Revitive SAS,

[phone] (IT)

[phone] (ES)

[e-mail]

[e-mail]

[e-mail]

IE:

Tel: [phone]

UK

CA

0086

CE

2797

Copyright © 2021 Actegy Ltd. All rights reserved. Actegy® and Revitive® are registered trademarks of Actegy Ltd. The Revitive product is a proprietary design and is protected by applicable design laws.

AW 6012_TSS05_18191366 11.2021