Radiancy Mistral User manual

User Manual
August 2009, Revision 07

User Manual
August 2009, Revision 07

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© 2007-2009 Radiancy Inc. All right reserved.
Mistral User Manual, August 2009. Part Number: 2011580. Revision 07
Note: The information in this document is confidential and proprietary. It is provided to
customers and authorized representatives of Radiancy only. The content of this manual is
furnished for informational use only, is subject to change without notice and should not be
construed as a commitment by Radiancy Inc.
LHE is a registered trademark of Radiancy Inc. in the United States and/or in other countries.
The Quality Management System of Radiancy Ltd. complies with the Quality Management
Standard ISO 13485-2003.
Manufacturer: Radiancy (Israel) Ltd., 5 Hanagar St., P.O. Box 7329, Hod
Hasharon, 45240, Israel, Tel: [phone], Fax: [phone]
www.radiancy.com
Authorized European Representative: Obelis S.A,, Av. de Tervuren
34 Bte .44, B-1040 Brussels, Belgium. Tel: [phone], Fax: 32
(0) 2 732 6003, GSM 07545 4660, e-mail: [email protected]
KEMA Notified Body.
Contact Information
Customer satisfaction is a Radiancy priority. To help us in providing you with
the best possible product and support, please send us your comments and
suggestions. Contact us at the addresses and telephone numbers below:
US
Radiancy Inc.
40 Ramland Road South, Suite 200
Orangeburg, NY 10962
USA
Toll Free: 888 661-2220
Tel: [phone]
Fax: [phone]
com.diancyra@info:mail-E
Israel
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240
Israel
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

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Table of Contents
1. INTRODUCTION TO THE SYSTEM 1
2. SYSTEM DESCRIPTION 2
2.1. S YSTEM C OMPONENTS AND C ONTROLS :........................................2
2.2. M AJOR P RECAUTIONS & W ARNINGS ..............................................7
3. INITIAL SET UP 14
3.1. U NPACKING M ISTRAL ....................................................................14
3.2. E LECTRICAL R EQUIREMENTS ........................................................14
3.3. I NSTALLATION ..............................................................................15
4. OPERATION AND TREATMENT PROTOCOLS 17
4.1. G ENERAL G UIDELINES FOR THE O PERATION OF M ISTRAL ................17
4.2. U SING THE T OUCH S CREEN C OMPUTER .........................................19
4.3. P RE -T REATMENT C ONSIDERATIONS ..............................................35
4.4. P RE -T REATMENT P REPARATIONS ..................................................36
4.5. S KIN P HOTO R EJUVENATION ........................................................40
4.6. H AIR R EMOVAL ............................................................................47
4.7. A CNE T REATMENT ........................................................................55
4.8. P SORIASIS T REATMENT ................................................................60
4.9. S KIN T IGHTENING .........................................................................66
5. MAINTENANCE 71
5.1. C LEANING I NSTRUCTIONS .............................................................71
5.2. P ARTS & A TTACHMENTS ...............................................................73
6. ADVERSE EVENTS REPORT FORM 75
7. TROUBLESHOOTING 78
8. MISTRAL SERVICE 79
9. WARRANTY 80

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List of Figures
Figure 1: Mistral Main System......................................................................2
Figure 2: Front Panel ...................................................................................3
Figure 3: Back Panel....................................................................................3
Figure 4: Right Side Panel ...........................................................................4
Figure 5: Handpiece.....................................................................................4
Table 1: Handpiece Color Identification........................................................5
Figure 6: Footswitch.....................................................................................5
Table 2: Technical Specifications.................................................................6
Table 3: International Standards Labels.......................................................9
Table 4: Additional Labels...........................................................11
Figure 7: Handpiece Connection................................................................16
Figure 8 - Pulse Counters ..........................................................................19
Figure 9: Password Entry...........................................................................20
Figure 10: Home Page...............................................................................21
Figure 11: Tutorial/Help Page ....................................................................21
Figure 12: Settings Page............................................................................22
Figure 13: Test Mode 1..............................................................................25
Figure 14: Test Mode 2..............................................................................25
Figure 15: Test Mode 3..............................................................................26
Figure 16: Test Mode 4..............................................................................26
Figure 17: DT Select Application................................................................27
Figure 18: DT Treatment Page...................................................................27
Figure 19: HR DT Treatment Page.............................................................29
Figure 20: DB Patient Search.....................................................................30
Figure 21: DB Patient Details.....................................................................30
Figure 22: DB Clinical History ....................................................................31
Figure 23: DB Treatment Log.....................................................................31
Figure 24: DB Edit Record .........................................................................32
Figure 25: DB Select Application................................................................33
Table 5: Data Base Application Selection...................................................33

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Figure 26: DB Treatment Mode..................................................................34
Figure 27: DB Save Treatment Data..........................................................35
Table 6: Energy Level Setting - SR............................................................42
Table 7: Required Results for Appropriate Energy Setting .........................43
Table 8: Energy Level Setting - HR............................................................49
Table 9: Treatment Course Recommendations..........................................53
Table 10: Energy Level Setting - AC..........................................................57
Figure 28: Plaque Psoriasis .......................................................................61
Table 11: Energy Level Setting - PSOR.....................................................64
Table 12: Energy Level Setting - ST...........................................................67
Figure 29....................................................................................................71
Figure 30....................................................................................................72
Figure 31....................................................................................................72
Figure 32....................................................................................................72
Figure 33: Area Adaptor.............................................................................73
Figure 34: Fuse Location............................................................................74
List of Tables
Table 1: Handpiece Color Identification........................................................5
Table 2: Technical Specifications.................................................................6
Table 3: International Standards Labels.......................................................9
Table 4: Additional Labels...........................................................11
Table 5: Data Base Application Selection...................................................33
Table 6: Energy Level Setting - SR............................................................42
Table 7: Required Results for Appropriate Energy Setting .........................43
Table 8: Energy Level Setting - HR............................................................49
Table 9: Treatment Course Recommendations..........................................53
Table 10: Energy Level Setting - AC..........................................................57
Table 11: Energy Level Setting - PSOR.....................................................64
Table 12: Energy Level Setting - ST...........................................................67

1Mistral User Manual
1. INTRODUCTION TO THE SYSTEM
Mistral is a Light and Heat Energy (LHE
®
) based multi-application
device for the treatment of:
•Hair Removal (HR)
•Skin Photo Rejuvenation (SR) (skin texture, fine lines)
•Pigmented lesions (sun spots, age spots)
•Vascular lesions (telangiectasias, spider veins)
•Acne Clearance (AC)
•Psoriasis Care (PSOR)
•Skin Tightening (ST)
Mistral consists of a console, a Footswitch, and up to 8
interchangeable Handpieces. Each Handpiece contains a pulse
switch, a ready indicator light and an application specific lamp. The
Handpiece is held by the operator and placed directly upon the
treatment area. In this manual, the term operator applies to all qualified
personnel trained to operate the Mistral system.
Important Note – The Mistral user manual is meant as a starting point
for treatment, a reference guide of general recommendations. As you
gain more experience with the device, you may use your personal
expertise to better individualize treatment parameters.

2 Revision 07, August 2009
2. SYSTEM DESCRIPTION
This chapter provides a detailed description of the Mistral system; its
main components, controls, and technical specifications. Please
review this material to familiarize yourself with controls, ports and
connectors, as well as the consumable items used during treatment.
2.1. System Components and Controls:
The Mistral system consists of the following main components
(Figure 1):
•System console (main unit)
•Interchangeable handpieces
•Footswitch
Figure 1: Mistral Main System
Handpieces
Console