piomic COMS One Manuel utilisateur
Ref.: 01.0000
COMS One
Instructions for Use
DE Gebrauchsanweisung
FR Mode d‘emploi
IT Istruzioni per I‘uso
ES Instrucciones de uso
2
X. KAPITELNAMEASSISTANCE FOR LAY USERS / HILFE FÜR LAIENANWENDER
ASSISTANCE POUR UTILISATEURS PROFANES / ASSISTENZA PER UTENTI
COMUNI / AYUDA PARA USERIOS LEGOS
EN: Please read the entire instructions for use before trying to operate this device.
If you have any questions about your COMS One system, please contact your
healthcare professional at the number below:
DE: Bitte lesen Sie die Gebrauchsanweisung vollständig durch, bevor Sie dieses Gerät in
Betrieb nehmen. Wenn Sie Fragen zu Ihrem COMS One System haben, wenden Sie sich bitte
unter der untenstehenden Nummer an das medizinische Fachpersonal:
FR: Lire l’intégralité du mode d’emploi avant d’essayer d’utiliser ce dispositif médical. Pour
toute question au sujet de votre système COMS One, veuillez vous adresser à votre pro-
fessionnel de santé au numéro ci-dessous:
IT: Leggere l’intero manuale di istruzioni prima di provare a mettere
in funzione il dispositivo. Per qualsiasi domanda sul sistema per la COMS One, contattare il
proprio medico al seguente numero:
ES: Lea las instrucciones de uso en su totalidad antes de empezar a utilizar este dispositivo. Si
tiene alguna pregunta sobre el sistema COMS One, póngase
en contacto con su profesional sanitario en el siguiente número:
EN :Healthcare professional contact information / DE: Kontaktinformation medizinischen Fachpersonal
FR: oordonnées du professionnel de santé / IT: Dati di contatto del medico/
ES: Información de contacto del profesional sanitario
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ENGLISH
1. INTRODUCTION
The COMS One Therapy System for Combined Optical and
Magnetic Stimulation, hereinafter called “COMS One”, is
approved exclusively for the use as specied in these
Instructions for Use.
Please read the information and note that these Instructions
for Use must be kept with the device.
The compact and portable COMS One offers simple and
comfortable wound therapy. Its use of optical and magnetic
stimulation is clinically proven to be effective in promoting
wound healing.
Intended purpose/Indications (When to use the device)
The COMS One Therapy System is intended to promote
wound healing by combined optical and magnetic
stimulation, in addition to standard of care. Indications for the
COMS One Therapy System are chronic leg and foot ulcers.
Contraindications (When not to use the device)
• Active skin cancer, history of skin cancer or any other
localized cancer, precancerous lesions or large moles in
the areas to be treated
• Pregnancy
Intended User Population
The COMS One should only be operated by properly in-
structed adults. Lay users including patients shall only use the
device upon instruction by a professional. All users shall not
be hard of hearing or deaf, must have adequate visual facul-
ty and shall be comfortable with the use of electronic devices.
Intended patient population
The COMS One is intended to be used on patients only
exhibiting conditions as described in the indications for use.
Intended Use Settings
The COMS One system is intended for use in professional
healthcare and home care settings.
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X. KAPITELNAME2. WARNING AND SAFETY INSTRUCTION
WARNING
• Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
• Indicates a potentially hazardous situation which, if not
avoided, could result in minor or moderate injury.
Safety related tip
• Indicating useful information about the safe use of the
device
The COMS One is intended for use as described in these
Instructions for Use.
Piomic only takes responsibility for the effect on safety,
reliability and performance of the COMS One if it is used in
accordance with the Instructions for Use.
Please read and observe these cautions and safety in-
structions before operation. Note that these Instructions for
Use are a general guide for the use of the product. Medical
situations must be addressed by a physician.
These Instructions for Use must be kept with the device.
WARNING
• Pacemaker operation may be adversely affected by
exposure to pulsed electromagnetic elds. Physicians
should not prescribe a therapy in case the treatment is
in close proximity to the pacemaker in order to prevent
malfunctioning of the pacemakers.
• Do not re-use articles labelled “single-use” in order to
prevent from infections and cross-contaminations.
• Do not use consumable when the sterile packaging is
damaged or has expired. Using unsterile consumables
can lead to infections.
• Unplug the device before cleaning and disinfection. It
may result in electric shock if the device is plugged in
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ENGLISH
during cleaning and disinfection.
• Do not clean, disinfect or perform other service and
maintenance tasks during use of the device.
• Do not apply the device while it is charging. Non-
observance can lead to electric shocks.
• Do only use the original power supply certicated with
IEC 62368 -1 and USB cable for charging. Using other
power supplies or cables may result in electric shock or
electromagnetic interference that prevents the device or
other devices from operating properly.
• Store the system out of the reach of children and babies
to minimize the risk of strangulation from cables and
straps
• The strap is not sterile. Cover other wounds in proximity
of the strap before xating the strap in order to prevent
infections.
• Do not open or modify the device. Non-observance can
lead to electric shocks.
CAUTION
• Do not immerse the device directly in water or other
liquids (not suitable for use while bathing, showering)
and do not use in a hazardous explosive environment.
Non-observance can lead to electric shocks.
• Do not use accessories other than those specied or sold
by Piomic in order to ensure therapeutic performance.
• Fix the strap carefully to ensure no pressure oedemas are
created.
• Do not use any damaged parts in order to ensure thera-
peutic performance.
• Do not apply device more than once within 12 hours on
the same location to prevent overstimulation of the tissue.
• Do not apply device in case of known allergies to
incorporated surface materials (Silicone, Elastan,
PolyAmid, Polypropylen, Synthetic Rubber) to prevent
allergic reactions.
• Use of controls or adjustments or performance of pro-
cedures other than those specied herein may result in
hazardous radiation exposure.
• Do not use the device if you use photosensitizing agents
/ medications in order to prevent from photo-allergic
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X. KAPITELNAME reactions.
• Do not look directly into the light source on the bottom of
the device. It may result in eye injuries.
• Do not operate HF (high-frequency) surgical equipment
in combination with the device. It can inuence the
operation of the device.
• Do not use the device if it is closer than 30 cm
(12 inches) to wireless communications equipment, such
as wireless home network routers, mobile phones, cord-
less telephones and their base stations. This can prevent
the device from working properly.
• Do not use the device adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the
device should be observed to verify normal operation in
the conguration in which it will be used.
Safety related tip
• Do not dry the device with a microwave in order to
prevent from device damage.
• Do only use cleaning and disinfection agents as descri-
bed in the section “Cleaning and Disinfection” to prevent
device damage
• Do not use the device in proximity to an MRI (Magnetic
Resonance Imaging) scanner. Non-observance can lead
to considerable danger.
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ENGLISH
Warning Indicator
Temperature Indicator
Battery Indicator
COMStouch Interface
COMSx/COMSrex
Interface
On/Off Button
Charging Socket
COMS One (Ref. 01.0000)
COMStouch (Single Use/Applied Part /Ref. 01.0001)
COMSx (Single Use/Ref. 01.0002)
Interface to COMS One
Device
Interface to patient
Strap (self adhesive)
Loops
3. MAIN ELEMENTS OF THE SYSTEM
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X. KAPITELNAME
COMSrex (Single Patient Use/Ref. 01.0004)
Charger (Ref. S008ACM0500200)
Strap
Loops
Hooks
Upon delivery, check the COMS One system for complete-
ness and general condition.
The COMS One system was veried in combination with the
accessories listed above. For correct and safe operation use
the COMS One with Piomic accessories only.
COMS One Power Supply
USB Cable
Plugs
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ENGLISH
4. BATTERY CHARGING
The charger has not been IP tested. Please charge device at a
dry location.
The USB cable can only be used for charging COMS One
with the charger and COMS One shall not be connected to
computers or other devices with the USB-cable.
1. Select plug matching your wall outlet and attach it to the
charger (initial use only).
CAUTION
• Do not apply the device while it is charging. Non-
observance can lead to electric shocks.
• Do only use the original power supply certicated
with IEC 62368-1 and USB cable for charging.
Using other power supplies or cables may result in
electric shock or electromagnetic interference that
prevents the device or other devices from operating
properly.
2. Plug the charger into a wall outlet and attach the USB
cable to the COMS One power supply and the COMS
One.
3. The battery indicator will indicate charging. During char-
ging the light below the battery symbol will be blinking
green. When the battery is fully charged the battery
indicator will stop blinking and indicate battery full with
a solid green light.
It takes approximately 2 hours to fully charge the device.
When the device is fully charged, it has enough power for at
least 6 treatments. The battery has an expected lifetime of 3
years. After 3 years of intensive usage, it may no longer be
sufcient for 6 treatments with one charge.
Remove the charger from the wall socket and pull the USB
plug out of the USB socket to disconnect device from the
mains supply.
Therefore charger and device must be placed easily access-
ible. Let the device rest 5 minutes after charging.
1
2 3 4
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X. KAPITELNAME
The COMS One offers a non-invasive and non-toxic
therapeutic approach to promote wound healing. The
system combines the technologies of pulsed electro-
magnetic elds and photon emission applied locally to the
wound area.
A therapy takes 16 minutes. In order to reach the scienti-
cally proven promotion of wound healing the therapy
shall be performed 2-3 times per week and be
repeated over the course of two months.
CAUTION
• Do not apply device more than once within 12 hours on
the same location to prevent overstimulation of the tissue.
Temporary increased exudate production and modied pain
perception cannot generally be excluded for this therapy.
Applicable accompanying wound care measures such as in-
ammation control, pain and exudate management, moisture
control and removal of wound debris must be addressed.
5. THERAPY DURATION AND REPETITION
16 minutes
6. THERAPY
1. Open the COMSx packaging and place strap within
reach of the device.
2. Take a packaged COMStouch and check that maximal
wound size is within the diameter of the COMStouch.
WARNING
• Do not use the COMStouch if the sterile packaging is
damaged or has expired.
8 cm
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