SYSTEM DESIGN AND SPECIFICATION

The BRH-A2 System is assembled in a specially designed cart. The cart encloses electrotherapy and ultrasound therapy medical devices, computer control, operator interface including touch screen. The BRH-A2 system is powered by standard one phase 120 or 230 V power supply.

BRH-A2 System General View

The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is intended for ultrasound and neuromuscular stimulation

Therapeutic Ultrasound:
1. Pain relief
2. Reduction of muscle spasm
3. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion

General System Specifications

The BRH-A2 System meets the requirements of the following standards:

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
(Consolidated Text)

“Medical electrical equipment. Part 1:General requirements for safety and essential performance”

IEC 60601-2-5:2009

“Medical electrical equipment. Part 2-5: Particular requirements for the safety of ultrasonic-physiotherapy equipment”

IEC 60601-2-10:2016
“Medical electrical equipment. Part 2-10 Particular requirements for the safety of nerve and muscle stimulators.

EN ISO 14971:2012

“Medical devices – Application of risk management to medical devices”- including residual risks evaluation.
IEC 60601-1-6:2010
“Medical electrical equipment. Part 1-6: General requirements for safety – Collateral Standard: Usability”
IEC 60601-1-8:2006

“Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance– Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems”

IEC 60601-1-2: 2007 /AC:2010

“Medical electrical equipment. Part 1-2: Electromagnetic compatibility – Requirements and tests”

ISO 62304: 2006/AC:2008

Council directive 93/42/EEC

“Medical Device Software Development”

Council directive 93/42/EEC

General

Power Input

Option 1 (For Europe): 230 V~; 50/60 Hz; 2 A
Option 2 (For US/Canada): 120 V~; 60 Hz; 4 A

Directive

MDD 93/42EEC ,Annex II

Mains Fuses

For Europe – (5 x 20 mm): 2x (T4AH250V)
For US/Canada – (5 x 20 mm): 2x (T8AH250V)

Size(height x width x depth)

56 x 42 x 31 cm

Weight

10 kg

Environmental Conditions for Transport and Storage

Temperature

During work: From +50oF to +104oF
In store: From 40oF to 167oF

Humidity

During work: From 30% to 75% RH (not condensed)
In store: From 20% to 80% RH (not condensed)

Pressure

During work: From 700 hPa to 1060 hPa
In store: From 700 hPa to 1060 hPa

System Q1 Ultrasound

Ultrasound frequencies
1 MHz ±5% to 3 MHz ±5%
Maximum Output Power
8 W with at 4 cm2 transducer

Maximum Intensity

2.0 W/cm2

Automatic Shut Off

Yes

Treatment Timer
0 to 30 minutes

Contact Monitor

Light on transducer

Transducer’s Part Number

Ma-11cb

System Q2 Electrotherapy

Waveform

4 Pole Interferential mode

Max Output Current (mA)

0-65±10% mA RMS, max 1 kohm load

Max output Voltage (V)

0-65±10% volts RMS, 1 kohm load

Maximum Current Density (2 inch/dia)
3.2 mA/in2
Treatment Timer
0 to 30 minutes