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SP3 Users Manual 2016

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0% found this document useful (0 votes)
278 views30 pages

SP3 Users Manual 2016

Uploaded by

taily barreto
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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SilkPeel® 3

Users’ Manual

Envy Medical, Inc.


5150 East Pacific Coast Highway Suite 720
Long Beach, CA 90804
(818) 874-2700

TABLE OF CONTENTS
PREFACE .............................................................................................................4

CHAPTER 1: GENERAL OVERVIEW ..................................................................5


1.1 Treatment Objectives
1.2 System Features
1.3 System Description
1.4 Technical Specifications

CHAPTER 2: INSTALLATION ............................................................................12


2.1 Installation Requirements
2.2 Unpacking and Inspection
2.3 Installation
2.4 Moving the System

CHAPTER 3: OPERATION .................................................................................14


3.1 Preparation

CHAPTER 4: MAINTENANCE ...........................................................................16


4.1 Daily Maintenance
4.2 Cleaning the Treatment Tips and Handpiece
4.3 Installing an O-Ring
4.4 Disconnecting and Replacing Tubing
4.5 Maintaining the External Air Filter

CHAPTER 5: TROUBLESHOOTING ..................................................................21


5.1 No Power
5.2 Blown Fuse
5.3 Red Indicator Illuminated / Vacuum Pump Not Operating
5.4 No Vacuum
5.5 No Topical Flow
5.6 Amber Indicator Illuminated

CHAPTER 6: CONTACT INFORMATION ........................................................25

CHAPTER 7: DISCLAIMER ................................................................................26

CHAPTER 8: TERMS OF WARRANTY .............................................................27

SilkPeel®3 Users’ Manual 2


 2016 Envy Medical RCA-DOC-0205 (v1)
LIST OF FIGURES
Figure 1: Serial Number Plate ..................................................................................... 4
Figure 2: Exfoliation Magnified .................................................................................. 5
Figure 3: Front Console ............................................................................................... 6
Figure 4: Front Console Con’t ..................................................................................... 7
Figure 5: Back Panel .................................................................................................... 8
Figure 6: Accessories ................................................................................................... 9
Figure 7: Handpiece................................................................................................... 10
Figure 8: Diamond Treatment Tips………………………………………………10
Figure 9: Front Console Tubing Connections .......................................................... 13
Figure 10: Treatment Head and Handpiece Tip Assembly ....................................... 14
Figure 11: Supply and Waste Manifolds ....................................................................... 15
Figure 12: Recommended Passes ................................................................................ 16
Figure 13: Removing Tubing from a Quick Disconnect Fitting ............................... 17
Figure 14a: Release External Air Filter ........................................................................ 18
Figure 14b: Align Grey tab with Corner ...................................................................... 18
Figure 14c: Pull down on Filter Housing ..................................................................... 19
Figure 14d: Remove Locking Disc ................................................................................ 19
Figure 14e: Unscrew Alignment Ring .......................................................................... 19
Figure 15a: Slide Out Black Fuse Box........................................................................... 21
Figure 15b: Remove Fuse Box ....................................................................................... 21
Figure 15c: Replace Both Fuses .................................................................................... 21

LIST OF TABLES
Table 4-1: Recommended Routine Inspection and Maintenance Schedule ........... 20
Table 5-1: Troubleshooting Overview……………………………………………..24

Disclaimer: This manual is not intended as a comprehensive guide for all aspects of treatment. Envy Medical highly recommends the operator confer with the
Department of Labor, Licensing, and Regulation or other such regulatory body in his/her respective state or country regarding legal use of this system. Envy
Medical declines any responsibility for the direct consequences or side effects experienced by individuals undergoing treatment. Operators must be trained at the
initial sale by authorized personnel. Because of our ongoing commitment to product quality and innovation, we reserve the right, at any time, to discontinue or
modify specifications, prices, designs, features, models or equipment without incurring obligation. This manual should always accompany the unit and its
location must be known to all personnel operating the unit. Additional copies of this manual are available from Envy Medical.

Copyright © 2015 by Envy Medical. All rights reserved. No part of this manual may be reproduced or copied in any form or by any means, graphic, electronic
or mechanical, including photocopying, typing, or information and retrieval systems, without written permission from Envy Medical.

SilkPeel®3 Users’ Manual 3


 2016 Envy Medical RCA-DOC-0205 (v1)
PREFACE

Envy Medical would like to thank you for your choice of the SilkPeel ®3 the newest breakthrough innovation that
combines precision non-invasive exfoliation with Dermalinfusion® to address patient-specific skin conditions. This
device has been specifically designed for aesthetic applications and represents the best choice for the medical
professional.

Envy Medical strongly advises the operator to read this manual thoroughly. The following chapters provide a
description of the system, the technical specifications, and installation, operating, and maintenance instructions.

Please write your serial number in the space provided below. You will find a similar tag on the back of your
SilkPeel®3 toward the lower right-hand corner.

My SilkPeel serial number is:

________________________

Figure 1: Serial Number Plate

NOTE

The SilkPeel ® 3 warranty is void if:


• Anyone other than authorized personnel install and/or service the equipment.
• Solutions other than Envy Medical topical solutions are used with the
SilkPeel®3 .
• Electrical facilities at the installation site do not comply with all application codes, including IEC and UL
requirements.
• The device is not used in accordance with the instructions specified in this manual.
(See Chapter 8 for full Terms of Warranty.)

PATENTS

The SilkPeel® Dermalinfusion® System is protected by United States Patent #6,695,853 and #7,658,742. Other
national and international patents pending.

SilkPeel® Dermalinfusion® and Lumixyl® are registered trademarks of Envy Medical, Inc.
ClarityMD™ is a trademark of Envy Medical, Inc.

OPERATOR RESPONSIBILITY

Personnel operating the unit must have a thorough understanding of the proper operation of the system. Operators
must be trained at the initial sale by authorized personnel. Additional training sessions may be arranged for a fee by
contacting Envy Medical. Envy Medical is not responsible for injury or damage resulting from improper use of the
system. If there is any doubt concerning the use of the SilkPeel 3 ® or the operator’s manual, contact Envy Medical
immediately for assistance.

SilkPeel®3 Users’ Manual 4


 2016 Envy Medical RCA-DOC-0205 (v1)
CHAPTER 1: GENERAL OVERVIEW

1.1 TREATMENT OBJECTIVES

The SilkPeel®3 has been designed to perform a progressive and controlled exfoliation of the skin simultaneously with
Dermalinfusion®, the delivery of unique topical solutions. The treatment objective is to improve outcomes of
dermatological conditions.

Figure 2: Exfoliation Magnified


Operating on a closed-loop vacuum system, the medical grade diamonds exfoliate
the outer layer of skin while delivering a topical dermaceutical to the skin
at a controlled intensity, stimulating new cell growth.

The main indications of use are:


• General microdermabrasion
• Topical-enhanced exfoliation

SilkPeel®3 Users’ Manual 5


 2016 Envy Medical RCA-DOC-0205 (v1)
1.2 SYSTEM FEATURES

The following section identifies the features of the SilkPeel®3:


E
D F
B

Figure 3: Front Console


J

1.2.1 Front Console

The front console contains the following:

A On/Off Switch Turns the system on (I) and off (Ο)

B Overflow Indicator A red light that illuminates when the waste jar is overfull and needs to be
emptied

C Preventative An amber light that illuminates when the system needs to


Maintenance be serviced
Indicator

D INTELLIFLOW Indicates the flow of topicals through the system between


Knob 00.0-100.0%. Adjust the topical flow for treatment. Flow
Increases when you turn the knob clockwise. Flow is also
dependent upon vacuum; therefore, set vacuum first, then
adjust flow.

SilkPeel®3 Users’ Manual 6


 2016 Envy Medical RCA-DOC-0205 (v1)
E Vacuum Display Indicates the vacuum from 2-11+PSI

F Vacuum Knob Adjusts the vacuum for treatment.


Vacuum increases when you turn the knob clockwise.

G Vacuum Coupler Large quick disconnect fitting where the blue vacuum tubing from the
handpiece connects to the unit

H Supply Coupler Small quick disconnect fitting where the clear supply tubing from the
handpiece connects to the unit

I Supply Tubing Clear tubing connecting the handpiece and the unit

J Vacuum Tubing Transparent blue tubing connecting the handpiece and unit
unit

Figure 4: Front Console Con’t.

K Waste Manifold Threaded cap for attaching a glass waste jar

L Residual Waste Expels residual solution and waste into waste jar
Tubing

M Float Switch Activates the red Overflow Indicator if the waste jar is not emptied

N Supply Manifold 1 Threaded cap for attaching a bottle of solution

O Supply Manifold 2 Threaded cap for attaching a bottle of solution

SilkPeel®3 Users’ Manual 7


 2016 Envy Medical RCA-DOC-0205 (v1)
P Uptake Tubing 1 Intakes topicals from the supply jar into supply tubing

Q Uptake Tubing 2 Intakes topicals from the supply jar into supply tubing

R Bottle Selection Toggles between manifolds 1 and 2


Switch

V
W

Figure 5: Back panel

1.2.2 Back Panel

S Handpiece Hook Location for storing the handpiece between treatments

T External Air Filter Houses the filter element

U Hour Meter Displays number of hours SilkPeel® MD Platinum has run

V Power Cord Housing into which the power cord plugs. The lower
Housing/Fuse Box compartment holds the fuses

W Vacuum Muffler Vents vacuum pressure and muffles exhaust sound

SilkPeel®3 Users’ Manual 8


 2016 Envy Medical RCA-DOC-0205 (v1)
X

Figure 6: Accessories

1.2.3 Accessories

X Plastic Cleaning Custom tray for autoclaving treatment heads.


Tray Extra inserts may be purchased for autoclaving 14 treatment heads

Y O-Ring Tool Tool with hooked end to assist installation of a new o-ring

1.3 SYSTEM DESCRIPTION

The SilkPeel®3 uses a closed loop vacuum system to exfoliate and deliver topicals onto the skin. When its handpiece
tip is brought in contact with the treatment area, the vacuum source gently pulls the tissue being treated through the
hole in the tip and into contact with the abrasive, diamond-encrusted treatment head. As the handpiece is drawn
across the skin, this abrasive surface exfoliates the tissue, delivers a topical dermaceutical, and vacuums away the
residuals into a sealed waste jar.

The main components of the SilkPeel®3’s operation are:

a) Vacuum pump. The vacuum pump is responsible for creating the negative (vacuum) pressure that pulls tissue
into contact with the treatment head and simultaneously delivers the topical to the skin through the
handpiece.

b) Handpiece. The handpiece consists of six components: the disposable cap, the treatment tip, the o-ring, the
wand, the supply branch and the vacuum branch.
SilkPeel®3 Users’ Manual 9
 2016 Envy Medical RCA-DOC-0205 (v1)
Treatment Tip Wand

Disposable O-Ring Groove Vacuum Branch


Plastic Cap Supply Branch

Figure 7: Handpiece

c) Diamond treatment tips. The SilkPeel®3 includes one set of 9 sterilizable, diamond-encrusted treatment tips
in the following grit sizes and diameters:
• Medium-Coarse (60 grit), 6mm diameter
• Medium-Coarse (60 grit), 9mm diameter
• Medium (80 grit), 6mm diameter
• Medium (80 grit), 9mm diameter
• Medium-Fine (100 grit), 6mm diameter
• Fine (120 grit), 6mm diameter
• Very Fine (140 grit), 6mm diameter
• Smooth, 6mm diameter
• Smooth, 9mm diameter

***Sold Separtely- diamond tips are available in the following sizes:


• Coarse (30 grit), 6mm diameter
• Coarse (30 grit), 9mm diameter
• Medium-Fine (100 grit), 9mm diameter
• Fine (120 grit), 9mm diameter
Figure 8: Diamond Treatment Tips
SilkPeel®3 Users’ Manual 10
 2016 Envy Medical RCA-DOC-0205 (v1)
• Very Fine (140 grit), 9mm diameter

Select the grit size based upon the nature of the procedure to be performed. 9mm tips are recommended for
treating larger areas of the face and body, such as the forehead, decolotte and back. The 6mm tip is best for
treating areas requiring greater precision, such as areas around the nose and mouth.

CAUTION: ONLY TREAT THE EYE AREA WITH A SMOOTH TREATMENT TIP, STRICTLY FOLLOWING
ENVY MEDICAL’s RECOMMENDED PROTOCOL AND SAFETY GUIDELINES. Do not ever treat the eyelids.
Envy Medical recommends using disposable Derm-Aid eye shields during any procedure for maximum patient
comfort and safety. Treatment heads MUST BE thoroughly cleaned before use and between patients.

d) Disposable Caps. SilkPeel®3 includes one pack of 12 disposable, single-use plastic handpiece caps. Also
included is one 2-pack of transparent blue cleaning caps are also provided to facilitate easy cleaning of the
system.

e) Vacuum and Topical INTELLIFLOW Adjustments. Two adjustment knobs are located on the front console
with a gauge to the left of the Vacuum knob. The display reads vacuum. Its corresponding knob can increase
or decrease the force with which the treatment area is brought in contact with the treatment head. Turn the
knob to the right (clockwise) to increase the vacuum pressure. Turn the knob to the left (counterclockwise)
to decrease the vacuum pressure. Higher vacuum pressure will pull the topical solutions through with greater
velocity. NOTE: Topical flow is dependent on the vacuum pressure setting; therefore, set vacuum
adjustments first and then set the corresponding flow.

The flow of the topical is displayed on the panel behind the knob. Turn its adjustment knob to the right
(clockwise) to increase the flow of the topical. Turn the knob to the left (counterclockwise) to reduce the
flow of the topical.

f) Topical Supply Bottle. The topicals are supplied in 4oz plastic bottles and thread into the manifolds on the
front of the SilkPeel®3 Select the topical based on the patient’s specific dermatological condition.

g) Disinfectant Supply Bottle. The SilkPeel®3 uses a 2oz bottle of OptiCide3 disinfectant with our validated
cleaning protocol. The bottle of OptiCide threads into the center (disinfectant supply) manifold (located
between the topical supply manifold and the waste manifold) on the front of the SilkPeel®3

h) Waste Jar. Residual solution and exfoliated tissue are deposited in a clear glass waste jar, which threads into
the right (waste) manifold on the front of the unit. When the waste jar is full, remove it from the SilkPeel®3
and dispose of the residual solution in accordance with OSHA standards. Disinfect or autoclave the waste jar
before replacing it in the SilkPeel®3.

i) External Air Filter. The external air filter is located on the rear panel of the unit. It is designed to prevent
moisture from reaching the vacuum pump. Under proper operating conditions, liquid should not collect in
the filter housing. Should liquid pass into the filter, it will collect in the filter housing. Periodic checks of
the filter are important to ensure proper operation. The filter should be changed every six months or 200
hours to ensure proper filtration and equipment protection (see Section 4.1).
SilkPeel®3 Users’ Manual 11
 2016 Envy Medical RCA-DOC-0205 (v1)
1.4 TECHNICAL SPECIFICATIONS

Supply Voltage: 4A 100-120V 60 Hz / 100V 50 Hz, single phase


(Also available in 220-240V 50/60 Hz, single phase)
Fuses: T4AL 250V UL 5X20mm
Power (W): 200w maximum
Current (A): 4A
Maximum Vacuum: > 10 PSI
Maximum Flow: > 50 mL/min (At maximum vacuum and 100%)
Abrading medium: Medical grade diamond (carbon)
US FDA Class: I Exempt (See CFR 878.4820)
Dimensions: 12.4” x 14” x 14.5”
Weight: 33.35 lbs / 15.1 kg
Operating temperature: 40°C maximum

CHAPTER 2: INSTALLATION

2.1 INSTALLATION REQUIREMENTS

Before installing the SilkPeel®3, verify:

• The electrical receptacle is an approved type and complies with local standards.
• The power input is the same indicated on the data plate of the unit, that is 100-120VAC 60Hz / 100V 50Hz or
220-240VAC 50/60Hz single phase.
• The SilkPeel3 ® voltage conforms to the electrical voltage of your outlet.
• The device is located on a suitable flat surface (i.e. table or Envy Medical-approved stand) with the front
console towards the operator.
• The device has 3 – 4 inches of free space all around it to ensure proper cooling.

NOTE
SilkPeel 3 HANDLING
®

The SilkPeel®3 weighs approximately 33 lbs. Use proper lifting


techniques when unpacking and repacking the unit.

2.2 UNPACKING AND INSPECTION

The SilkPeel®3 should be unpacked and installed by a trained Envy Medical representative.

Instructions for unpacking the SilkPeel®3 are as follows:

SilkPeel®3 Users’ Manual 12


 2016 Envy Medical RCA-DOC-0205 (v1)
1. Examine the shipping box for external damage or evidence of mishandling. You must immediately notify
Envy Medical or your Envy Medical representive IN WRITING if there is any visible damage.
2. Open the top cover of the box and carefully remove all the contents. Save all packaging materials in case
repacking and shipping is necessary at any future time. Should you misplace your box and foam padding,
replacements are available from Envy Medical at an additional cost. This newest model SilkPeel3 ® includes a
state-of-the-art, innovative shock absorption system to keep the pump in place during transit.
3. Compare the items in the box with the packing list and be sure that all items on the list are present. You
must immediately notify Envy Medical or the distributor IN WRITING of any discrepancies. Contents may
vary according to the model and accessories ordered.

CAUTION
RETAIN FACTORY PACKAGING MATERIALS

Do not ship a SilkPeel®3 without the factory packaging materials. Doing so may
result in damage to the components during shipping and void the warranty. Contact
Envy Medical at 888-848-3633 for packaging materials and repackaging
instructions.

2.3 INSTALLATION

The SilkPeel®3 is designed for easy installation, which is carried out as follows:

1. Place the SilkPeel®3 in its designated location.


2. Connect the power cord to the equipment at the power cord housing on the back of the unit. Plug the
system into a Ground Fault Interrupt (GFI) outlet.
3. Test the system for proper operation.
4. The handpiece has a tubing set installed. The other end of the tubing set has a coupler on each of the tubes to
connect it to the front of the machine. Connect the coupler attached to the blue tubing to the left fitting, and
connect the coupler attached to the clear tubing to the fitting on the right. (See Figure 8)

Insert Coupler attached to clear


flow tubing into the right fitting

Insert Coupler attached to


transparent blue vacuum tubing
into the left fitting
SilkPeel®3 Users’ Manual 13
 2016 Envy Medical RCA-DOC-0205 (v1)
Figure 9: Front Console Tubing Connections

2.4 MOVING THE SYSTEM

Most users of the SilkPeel®3 have more than one operator or utilize multiple treatment rooms. The SilkPeel®3 can
easily be moved between them using the custom SilkPeel®3 rolling stand, which is an optional accessory. The only
disassembly required is disconnection of the power cord to ease maneuvering. Rather than unplugging the power
cord from the electrical outlet for each move, it may be easier to install a power cord at each location, leaving them
in place. Rest the handpiece in the handpiece hook while moving.

If you operate in multiple offices or will require transporting the SilkPeel3 ® over longer distances, you may elect to
purchase the SilkPeel®3 ‘s custom rolling case. This travel case features custom-fit foam insulation for your
SilkPeel®3 and its accessories, a push-button retractable handle and inline skate wheels to ensure easy and reliable
transportation.

SilkPeel®3 Users’ Manual 14


 2016 Envy Medical RCA-DOC-0205 (v1)
CHAPTER 3: OPERATION

3.1 PREPARATION

Before beginning a treatment, the operator must:


• Evaluate the patient’s skin type and condition
• Determine the solutions, grit, and tip size that would be appropriate for the patient.
• Confirm that the treatment tip and tubing have been cleaned and the disposable cap is new.
• Screw the treatment tip onto the threading located at the top of the handpiece.
• Ensure a handpiece tip o-ring is installed in the o-ring groove.
• Attach the appropriate handpiece tip by sliding it over the o-ring using a twisting motion while applying
downward pressure.

Small Disposable Large Disposable Plastic


Plastic Caps Caps

9mm Treatment Tips


6mm Treatment Tips

Figure 10: Treatment Tip & Disposable Cap Assembly

SilkPeel®3 Users’ Manual 15


 2016 Envy Medical RCA-DOC-0205 (v1)
• Thread a clean waste jar into the waste manifold.
• Make sure your Bottle Selection Switch is set to the solution you want to use.
• Gently shake bottles of the topical solutions selected for the patient and thread it into the topical supply
manifolds (1 and/or 2).

Supply Manifold 2
Supply Tubing 2 Residual Waste
Tubing

Supply
Manifold 1

Float
Switch
Supply
Tubing 1
Bottle
Selection
Switch

Figure 11: Supply and Waste Manifolds

SilkPeel®3 Users’ Manual 16


 2016 Envy Medical RCA-DOC-0205 (v1)
CHAPTER 4: MAINTENANCE

The following sections outline routine maintenance protocols. At the end of the chapter, Table 4-1 provides an
overview of these recommended procedures.

4.1 DAILY MAINTENANCE

Proper cleaning of your SilkPeel®3 is imperative to your patients’ health and to prolonging the life of your unit.
Cleaning must be performed immediately after every SilkPeel®3 treatment and at the end of the day.

To clean the unit immediately after every SilkPeel®3 treatment:


1. Remove and dispose of the plastic disposable cap; remove treatment tip and clean in accordance with the
instructions listed below (at End of Day).
2. Place a blue sealed cleaning handpiece tip onto the handpiece.
3. Remove empty bottles of topical solution.
4. Turn the Bottle Selection Switch counterclockwise to point towards “2”. DO NOT USE WATER OR
ANY OTHER UNAPPROVED FLUID FOR DISINFECTING. Use of any unauthorized products in
your SilkPeel®3 will VOID your warranty.
5. Gently shake a bottle of Opticide3 disinfectant and thread it into the disinfectant supply manifold on
the SilkPeel®3.
6. Adjust the vacuum to 5 psi, and the flow to maximum.
7. Run the Opti-Cide3 solution through the system for 5 or 6 minutes, or until the handpiece tubing
appears to be nearly empty.
8. Remove the OptiCide with the unit still turned on. Turn the vacuum up to maximum, and run air
through the machine until it is aired out (about 30 seconds).
9. Turn the machine off, then empty and reattach the waste jar.
10. Turn the Bottle Selection Switch clockwise to point towards “1”. You are now ready to perform a
SilkPeel®3 procedure.

For end of the day maintenance:


1. Check the external air filter for residual liquid accumulation. If liquid is visible, replace the filter
according to the steps in Section 4.5. THIS STEP IS CRITICAL FOR PROPER MAINTENANCE OF
YOUR UNIT.
2. Use water, a mild cleansing solution to clean the front of the machine, if necessary.
3. Thoroughly disinfect the treatment heads and handpiece (see Section 4.2). Failure to do so may cause
damage to parts.
4. Reassemble the handpiece and reattach it to the front of the unit (see Figures 9, 10 and 11).

SilkPeel®3 Users’ Manual 17


 2016 Envy Medical RCA-DOC-0205 (v1)
4.2 CLEANING THE TREATMENT HEADS AND HANDPIECE

The treatment head should be thoroughly cleaned after each treatment:


a. Remove the plastic handpiece tip and discard it with your biohazardous waste.
b. Remove the treatment tip and clean by soaking in enzymatic detergent (such as Microzyme) for
15 minutes. The head should then be rinsed in hot running water and the abrasive surface
scrubbed with a brush to remove protein material.
c. The treatment tip can then be placed in OptiCide3 disinfecting solution. Read the label on the
OptiCide3 for the proper soak time.
d. If the treatment tip is to be cleaned in the unwrapped Plastic Cleaning Tray, the "flash" cycle may
be used. This is typically five minutes at a minimum temperature of 132ºC (270ºF) in a steam
autoclave. *NOTE: Autoclaves differ by manufacturer and specification; therefore always follow
manufacturer instructions in setting temperature and cycle time. Failure to follow manufacturer’s
instructions may result in damage to your treatment tip.

Figure 13: Removing Tubing from a Quick Disconnect Fitting

4.3 INSTALLING AN O-RING

Place one corner of the o-ring into the o-ring groove on the handpiece. Hook the opposite side of the o-ring with
the rounded end of the o-ring tool. Stretch the o-ring over the treatment tip post and into the groove. Work into
place with fingers, as necessary.

SilkPeel®3 Users’ Manual 18


 2016 Envy Medical RCA-DOC-0205 (v1)
4.4 DISCONNECTING AND REPLACING TUBING

Remove the coupler from the front of the machine by depressing the button below the fitting while pulling on the
metal coupler. To disconnect tubing from the coupler, press in on the white quick disconnect fitting, while using the
other hand to remove the tube. (See figure 13 above) To replace the tube, insert it into the fitting until you feel
resistance; pause, then push the tube slightly further into the fitting to lock the tube in place. Quick disconnect
fittings are called two-stage fittings because of this method of connection. Using force can cause damage to the quick
disconnect fitting. Such damage is not covered under warranty.

4.5 MAINTAINING THE EXTERNAL AIR FILTER

The external air filter is mounted on the rear of the SilkPeel®3 unit to protect the vacuum pump from overflow from
the waste jar. To prevent damage to the pump and to avoid contamination, it is critical to maintain the cleanliness
and integrity of the filter and filter housing. Under proper operating conditions, liquid should not collect in the filter
housing. DAILY checks of the filter are important to ensure proper operation. Should liquid accumulate in the filter
housing, follow the steps below to replace the filter and clean the housing.

The filter should be changed every six months or 200 hours to ensure proper filtration and equipment protection. To
replace the filter:

1. Slide the grey locking tab on the filter housing downward (see Figure 14a below).
2. With the locking tab still in a downward position, rotate the filter housing counterclockwise towards the
corner of the filter housing.
3. Once the grey tab is at the corner, pull the filter bowl down to remove. (see Figures 14b and 14c).

SilkPeel®3 Users’ Manual 19


 2016 Envy Medical RCA-DOC-0205 (v1)
Figure 14a: Release External Air Filter Figure 14b: Align Grey tab with Corner

Figure 14c: Pull down on Filter Housing Figure 14d: Remove black locking disc

Figure 14e: Remove alignment ring from filter


SilkPeel®3 Users’ Manual 20
 2016 Envy Medical RCA-DOC-0205 (v1)
4. Clean the filter bowl by soaking in warm water, then allowing to air dry.
5. Rotate the black locking disk located on top of the filter bowl to unlock and pull to remove it. (see Figure
14d).
6. Unscrew alignment ring from filter. (See Figure 14e) Place the new filter on top of the locking disk and the
alignment ring on top of the filter.
7. Replace the filter housing by reversing steps 1-5.

SilkPeel®3 Users’ Manual 21


 2016 Envy Medical RCA-DOC-0205 (v1)
Table 4-1 – Recommended Routine Inspection and Maintenance Schedule

Activity By Interval Requirement/Action

Clean exterior User Daily or as needed Clean quick disconnect fittings and
surfaces surrounding areas

Empty waste jar User Before use & Discard and clean waste jar regularly to
immediately after prevent overflow and damage to the unit
treatments

Clean treatment User Before use & after Autoclave or clean in ultrasonic cleaner
heads and treatments according to section 4.2
handpiece

Disinfect tubing User Before use & after Disinfect by running 2oz. OptiCide3
treatments Disinfecting Solution through unit when
changing topicals and at the end of the day.
See section 4.1

Check external air User Daily Monitor for topical overflow. Empty, clean
filter and replace as needed

Replace tubing User Monthly Replace if discolored, or if clogged with dry


topical due to improper cleaning

Check topical and User Monthly Ensure a tight connection between the
disinfecting uptake intake tubes and the quick disconnect
tubing fittings in the supply manifolds

Check residual User Monthly Ensure a tight connection between the


waste tubing residual waste tube and the quick
disconnect fitting in the waste manifold

Clean float switch User Monthly Clean with a moist cloth. Replace with
metal weights at bottom

Replace handpiece User As needed Follow instructions in section 4.3


tip o-ring

Preventative Envy Medical Upon illumination Unit requires service. Contact Envy
maintenance Service of amber indicator Medical technical support at 888-848-3633
Technician light

SilkPeel®3 Users’ Manual 22


 2016 Envy Medical RCA-DOC-0205 (v1)
CHAPTER 5: TROUBLESHOOTING

Potential problems can be minimized by following the routine schedule described in Table 4-1. Many of the
calls received by Envy Medical regarding the SilkPeel®3 are for operator-related issues and/or improper
cleaning and maintenance. Most of these problems can be resolved in the office by the user. This section
provides instructions for troubleshooting. Table 5-1 provides an overview of troubleshooting measures.

5.1 NO POWER

If the system does not start, check the following:


1. The power cord is properly connected.
2. The electrical outlet is “on” and is the correct voltage.
3. The “On/Off” switch on the front of the machine is in the “On” position (I).
4. The fuse has not blown.

5.2 BLOWN FUSE

If the fuse is blown, you will hear a pop and the system will have no power to the displays or the vacuum pump. Use
a small flathead screwdriver to slide the black fuse box from the bottom of the power cord housing. Remove both
fuses from their clip and discard them (See figures below). Replace with fuse marked as T4AL 250V only. It is
recommended to always have spare fuses on hand. To order spare fuses, visit the online shop at
www.shopenvymedical.com, or call toll free at (888) 848-3633.

Figure 15a: Slide Out Black Fuse Box


Figure 15b: Remove Fuse Box

Figure 15c: Replace Both Fuses

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5.3 RED INDICATOR ILLUMINATED / VACUUM PUMP NOT OPERATING

If the vacuum pump stops running during operation or does not engage when the “On/Off” switch is
turned on:
1. Check the waste jar. The waste manifold (where the jar threads into the machine) is equipped
with an automatic overflow detector. Should the operator neglect to empty the waste jar, the
pump will disengage and a red LED with a full jar symbol beneath it on the front of the unit
above the “On/Off” switch will illuminate. Should this occur, immediately turn the machine
off and remove the waste jar. Empty the contents of the jar as instructed above and replace it
into the waste manifold. Check the external air filter for liquid. Drain and/or clean, if
necessary (see section 4.5).
2. After completing step 1, or if the waste jar was not full, but the red light
remains on, consult Envy Medical technical support at 888- 848-3633.

5.4 NO VACUUM

If the pump is on but no vacuum is evident, occlude the handpiece tip and turn the vacuum knob to
maximum (though the display readout may not change). Check the following connections, testing
for vacuum between each step. NOTE: Vacuum will not build until the handpiece tip is occluded and
the vacuum loop is closed.
1. Ensure that a tight fit is achieved between the disposable cap and the treatment tip o-ring. If
the o-ring has broken or lost its seal, replace it with a new one.
2. Confirm that the vacuum tubing is firmly inserted into the fitting on the front of the
SilkPeel®3 unit.
3. Verify that the waste jar is threaded into the waste manifold correctly. If the threading on the
jar is not properly aligned with the threading on the manifold, vacuum pressure loss may
occur.
4. Verify that the External Air Filter is firmly in place (see section 4.5 for further instructions).
If the filter housing is not properly installed, vacuum pressure loss may occur.
5. If there is still no vacuum pressure evident, contact Envy Medical technical support at 888-
848-3633.

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 2016 Envy Medical RCA-DOC-0205 (v0.0.1)
5.5 NO TOPICAL FLOW

If the pump is on, vacuum is evident when the handpiece tip is occluded, yet no topical solution
appears to flow, perform the following steps:
a) Rule out vacuum pressure loss by following the steps listed in the preceding section. If the
vacuum pressure is compromised, there may be inadequate force to carry the topical through
the line. NOTE: Vacuum pressure will not build until the handpiece tip is occluded and the
vacuum loop is closed. If vacuum pressure passes all troubleshooting tests and pressure can be
felt at the handpiece tip, turn the machine off.
b) Remove the supply bottle from the manifold. Confirm there is solution in the bottle.
c) Gently shake a full supply bottle and thread it into the supply manifold.
d) Ensure that the clear supply tube is firmly inserted into the fitting on the front of the unit.
e) Turn the unit back on. Confirm that vacuum and flow are both set to maximum, occlude the
handpiece tip and check for flow. NOTE: Topical solutions will not flow until the handpiece
tip is occluded. Also, when beginning a new bottle of topical solution, it may take several
seconds for the topical to reach the handpiece. Monitor the clear supply line to determine
when solution has reached the handpiece.
h) If there is still no topical flow evident, contact an Envy Medical Customer Service
Representative by calling 888-848-3633.

5.6 AMBER INDICATOR ILLUMINATED

The amber indicator with the check mark symbol beneath it illuminates when the system requires
preventative maintenance. Preventative maintenance is routine service, and is NOT covered by your
warranty. Call Envy Medical to schedule service at 888-848-3633.

WARNING

The use of any parts, materials or service labor unauthorized by Envy Medical
may seriously damage your SilkPeel®3 and will VOID the warranty.

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SilkPeel®3 Operator’s Manual 26
 2016 Envy Medical RCA-DOC-0205 (v0.0.1)
Table 5-1 – Troubleshooting Overview

Symptom Probable Cause Action


The “On/off” switch on the Turn the “On/Off” switch to the “On” position.
front panel is in the “Off”
The system does not start position
(numbers are not shown on
Power disconnected Turn off the “On/Off” switch and check that the power
the display and the lights
cord is plugged into the electrical outlet and connected
are off)
to the unit’s power cord housing.
Fuse blown Replace the fuses in the power cord housing.
Waste jar full Turn off the unit and empty the waste jar. Restart the
Red LED is on and the
unit. If the waste jar is not full, call Envy Medical for
vacuum pump does not run
technical support.
Handpiece tip has lost a tight Replace the handpiece tip o-ring and reattach the
seal handpiece tip
Vacuum tube is not firmly Disconnect and reconnect the blue vacuum tubing
inserted into vacuum fitting from the vacuum fitting on the front of the unit.
No vacuum or vacuum loss
Waste jar improperly Remove the waste jar and re-thread it carefully into the
threaded into waste manifold waste manifold.
Waste jar has lost a good seal Slightly tighten waste jar.
in the manifold
Vacuum pressure loss Perform the troubleshooting steps above for “no
vacuum.”
No solution in supply bottle Remove the supply bottle and check for solution.
Replace with a new supply bottle if empty.
No topical flow or Topical uptake tubing Remove the topical uptake tubing from the supply
flow loss clogged manifold. Rinse under warm running water. Re-insert
the tubing.
Clog in tubing Remove tubing from machine and handpiece, blow
compressed air through tubing; or replace tubing with
new handpiece tubing set.
Display reads a negative Improper cleaning of the unit Call Envy Medical technical support. Unit must be
number of “.01” sent to Envy Medical’s service department for repair.
Tubing not inserted correctly Quick disconnect fittings are two-stage fittings. Insert
Tubing not inserting into tubing into the fitting until you feel resistance; pause,
fitting then push the tube slightly farther into the fitting to
lock the tube in place.
Amber indicator is on Requires service Call Envy Medical technical support.
External air filter has Cease use of unit immediately. Call Envy Medical
Unit is leaking overflowed into vacuum technical support.
pump

Envy Medical Technical Support is available at 888-848-3633.

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 2016 Envy Medical RCA-DOC-0205 (v0.0.1)
CHAPTER 6: CONTACT INFORMATION

For any problems, contact your service representative or Envy Medical directly:

Representative:

Contact Number:

Visit us on the web at www.EnvyMedical.com


Download forms and other materials at https://envymedical.box.com/CustomerCareKit

Technical Support
866-848-3633 (toll-free)
818-451-3333 (after hours emergency)

Corporate Offices
Phone: 818-874-2700
Fax: 818-874-1195
Email: info@envymedical.com
Mailing Address:
Envy Medical, Inc.
5150 East Pacific Coast Highway Suite 720
Long Beach, CA 90804

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 2016 Envy Medical RCA-DOC-0205 (v0.0.1)
CHAPTER 7: DISCLAIMER

This manual is not intended as a comprehensive guide for all aspects of treatment. Envy
Medical highly recommends the operator confer with the Department of Labor, Licensing,
and Regulation or other such regulatory body in his/her respective state or country regarding
legal use of this system. Operators must be trained at the initial sale by authorized personnel.
Envy Medical declines any responsibility for the direct consequences or side effects
experienced by individuals undergoing treatment.

The SilkPeel®3 warranty is void if:


• Anyone other than authorized personnel install and/or service the equipment.
• Solutions other than topical solutions purchased directly from Envy Medical and its
authorized distributors are used with the SilkPeel®3.
• Electrical facilities at the installation site do not comply with all application codes,
including IEC and UL requirements.
• The device is not used in accordance with the instructions specified in this manual.

Because of our ongoing commitment to product quality and innovation, we reserve the right,
at any time, to discontinue or modify specifications, prices, designs, features, models or
equipment without incurring obligation.

This manual should always accompany the unit and its location must be known to all
personnel operating the unit. Additional copies of this manual are available from Envy
Medical.

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 2016 Envy Medical RCA-DOC-0205 (v0.0.1)
CHAPTER 9: TERMS OF WARRANTY

The SilkPeel®3 warranty covers parts and labor for those items found to be defective due to
material or workmanship for one (1) year from the date of purchase. Should a technical issue
arise that cannot be resolved through our technical call department, the customer may obtain
a Return Merchandise Authorization number to return the unit to the technical support
center. The customer will be advised within two (2) business days of receipt of unit at the
service center about the nature of any required repairs or service and the estimated return
shipping date. The customer is responsible for shipping and insurance fees to our service
center and must ship the unit in its original packaging. Envy Medical will return the unit via
Ground delivery; the customer may opt to upgrade the shipping service for an additional fee.
Any repairs resulting from natural disasters, accidents, electrical system faults, negligence,
improper use of the device, improper cleaning of the device, improper maintenance of the
device, installations, servicing, repairs, or alterations to the unit carried out by personnel
other than persons authorized by Envy Medical are NOT covered by this warranty.

Exclusions: Any item that comes in direct contact with solution or that should be replaced on
a semi-regular basis is considered a disposable item and is not covered under this warranty.
Such items include, but are not limited to: solutions, tubing sets, o-rings, filters, fittings and
handpiece tips. The use of any parts or materials including solutions, filters, tubing, etc. that
are not authorized by Envy Medical will VOID this warranty. Removing or tampering with
the internals of the unit will also VOID this warranty, unless specifically authorized by an
Envy Medical representative. Preventative maintenances are not included in the warranty;
failure to perform preventative maintenances (based on usage and as indicated by the amber
light) will VOID this warranty.

Envy Medical shall not be held responsible for any failure in servicing derived from
circumstances beyond its control. In no case will a customer be entitled to claim
compensation for any damages incurred as a result of the device being out of service.

This warranty is non-transferable. All sales are final.

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 2016 Envy Medical RCA-DOC-0205 (v0.0.1)

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