Salient E-PEN User manual

User Manual
Manuel d’utilisation

1
1. Connect a battery to the hand-piece
How to Use
1) Setting
2) Needle Cartridge Connection & Removal
Step. 1 Step. 2 Step. 3
Step. 1 Step. 2 Step. 3

2
1. Connect a fully charged
battery to the hand-piece
2. Turn the battery clockwise
Adjust needle length by turning
the adjustment ring.
Shorter Longer
Adjustment ring for needle length
How to connect battery
3) Needle Length Adjustment

3
1. Thread the battery securely into the charging unit.
2. Insert the charger adapter into the charging unit and insert the
plug into a power outlet.
3. Red light on the charging unit will come on.
4. Charge 3-6 hours or until light turns green.
5. After charging, unthread the battery from the charger and thread
into the E-Pen
1. Have patient review and complete consent form.
2. Explain and answer questions about E-Pen procedure.
3. Clean patient’s skin with soap and water, alcohol pads or a cleanser to remove makeup, sunscreen and surface oils.
4. Take “before” pictures of the procedure area.
5. Apply numbing cream to the procedure area. Leave on per the product’s instructed time.
6. Cleanse again, thoroughly removing all numbing cream. Wipe skin with alcohol to ensure all numbing agent is
removed.
IMPORTANT: Anything remaining on the skin may increase the risk of complications post-procedure.
7. Apply the disposable EL-TE Cartridge™ to pen. Sleeve is non-sterile and single use only.
How to Charge Battery
How to Operate
1) Power ON/OFF
Connect battery to hand-piece and turn on the power button for operation.
Procedure Instructions
™

4
IMPORTANT: Unexpected complications may occur when products not proven safe for use with microneedling
are applied post-procedure.
NOTE: Soiled gloves should always be disposed of in a biohazard container. Do not reuse disposable gloves.
NOTE: The purpose of a sheath is to provide a covering that helps prevent the transmission of pathogens from
one patient to another. E-Pen is intended to be used only with provided Sleeve.
Remove the Sleeve by
carefully sliding it down
the E-Pen to prevent
soiling the handpiece.
Hold Sleeve
and insert E-Pen
body (without
cartridge) between
the white tab and
paper backing.
Peel back the
protective top cover and
the paper backing.
Pull Sleeve snug, remove
adhesive backing and
seal end.
Dispose of the Sleeve in a
biohazard container.
Sleeves are not intended
to be reused.
* After removal of the Sleeve
users’ gloves should be
removed, hands cleaned, and a
new pair of clean gloves
worn before proceeding to the
next patient.
Insert new microneedle
cartridge into
E-Pen. E-Pen
is now protected and
ready for use.

5
Contraindications
Treatment with this device is contra-indicated for patients with any of the following
conditions:
Precaution Before Use

6
Cleaning & Storage Instructions
Following the Procedure:
1. Immerse the device in Cidex® OPA at room temperature for 90 minutes. (Only immerse from the tip of the device
to the top of cone).
2. Rinse the cone end of the device (minimum of 3 times) with deionized water.
TYPE B APPLIED
PART
Class 2 Equipment
Stand-by
Do not throw away
with general household
waste
General warning sign
Keep away from rain
Fragile; handle with
care
This way up
Manufacturer
Serial number
Operating instruction
Alternating current
General mandatory
action sign
General prohibition
sign
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18

7
Salient warrants to the original purchaser that the merchandise is free from defects in material and workmanship
under normal use and service for a period of one (1) year from date of purchase. The obligation of Salient under
this warranty is limited, in its exclusive option, to repair or replace parts and materials which prove to be
defective.
One or more of the following events will serve to void the warranty:
2. Abuse or misuse.
All merchandise should be inspected for obvious damage upon arrival. If merchandise has been damaged in
made in writing within 10 days after delivery to the purchaser, and any claims not made within that period shall
be deemed waived and released.
IN NO EVENT SHALL SALIENT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES DUE TO ANY
CAUSE WHATSOEVER. No suit or action shall be brought against Salient more than one year after the related
cause of action has occurred.
THE FOREGOING CONSTITUTES SALIENT’S SOLE LIABILITY AND THE PURCHASER’S SOLE REMEDY WITH RESPECT
TO PRODUCTS SOLD BY SALIENT EXCEPT AS THUS PROVIDED, SALIENT DISCLAIMS ALL WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
WARNINGS
Electromagnetic waves discharged from mobile phone, radiotelegraphs, wireless toys can cause device
n the device OFF while the device
is in direct contact with the patient. Only use saline directly before and after using the device. Never use
unauthorized parts. All parts should be replaced by manufacturer’s authorized service personnel. Never use
Product Name E-PEN™
Model Number
DOA-EPEN
Manufactured for
Salient Medical Solutions Inc.
Weight After packaging is 1.5 lbs, 1 set/box
Electrical Requirements
AC Adapter In: 100-240Vac, 50-60Hz 0.3A
AC Adapter Out: 5.0Vdc; 2.0A
Charger Time
3-6 Hours
Working Time
4 hours per battery
Speed
7000 RPM (puncture rate)
Needles
12 pin, 32g, Stainless Steel, 2.0mm Maximum Penetration Depth
Operation
Cordless
Manufactured for
SALIENT MEDICAL SOLUTIONS Inc.
Toronto, Ontario
M3H 5T5 Canada
Tel: [phone]
Product Warranty
Salient Medical Solutions Inc.
5050 Dufferin Street, Units 110, 111, 115
Toronto, ON, M3H 5T5 Canada
Phone/Téléphone: 416-736-3553
Fax: [phone]
[email protected]
www.salientmed.com

8
1. Installation de la pile dans la pièce à main
1. S’assurer que le dispositif est éteint et le régler à « 0 » avant d’installer la cartouche.
2. Mettre des gants sans latex jetables.
3. Ouvrir la cartouche en la tenant à l’endroit et en retirant l’opercule Tyvek.
4. Installer la cartouche EL-TE en la poussant vers le bas et en la tournant dans le sens horaire
jusqu’à ce qu’elle ne tourne plus.
5. Retirer la cartouche EL-TE en tournant l’embout dans le sens antihoraire jusqu’à ce qu’elle
se dégage.
6. Jeter la cartouche EL-TE usagée dans un contenant pour objets pointus.
* Si une cartouche EL-TE est contaminée par inadvertance avant ou pendant l’installation (p.
ex., tombée par terre, emballage ouvert ou brisé, risque de contamination), la jeter et en
utiliser une nouvelle.
Utilisation du dispositif
1) Paramètres
2) Raccordement et retrait de la cartouche d’aiguilles
Étape 1É tape 2 Étape 3
* Si la cartouche n’entre pas correctement dans la pièce à main, elle pourrait être défectueuse.Z
Étape 1É tape 2 Étape 3
Fente 1
Fente 2

9
1. Insérer la pile entièrement
chargée dans la pièce à main.
2. Tourner la pile vers la droite.
Régler la longueur de l’aiguille en tournant
la bague de réglage.
Plus court Plus long
Bague de réglage pour la longueur de l’aiguille
Installation de la pile
3) Réglage de la longueur de l’aiguille