Fritonex PowerTube QuickZap User manual

Instruction manual English
®
FRITONEX AG, Breite 9, CH-3636 Forst (Switzerland)
Medical
certification
EN ISO 13485

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
3
Instruction manual
Tabel of contents Page
This instruction manual is considered an integral
part of the device. It shall be kept within reach at
all times. Exact compliance with these instruc-
tions is essential for the correct handling of the
device as well as for the safety of patient and
user.
Illustration of the device
Control panel with functions
Description of the device
Quick start guide
Battery and battery compartment
Specifications
Handling
Indications
Contraindications
Safety tips
Errors and malfunctions, function test
Accessories
Guarantee
Safety inspection
Conformity declaration CE 0482
Care, maintenance and storage
4
5
6
6
7
8
9
10
10
10
11
12
12
12
13
14
I. Risk of mutual interference see annex
«Technical description EN/IEC 60601-1-2»
English

4
Therapy head
Handhold with
cable can be
used instead of
therapy head
Cable with plug
for connection to
PowerTube
®
Cover of battery compartment.
Use a coin to open.
Requires one IEC 6LR61 9-volt
alkaline battery.
Insulation
Plug connection for
cable to handhold
Control panel
and display
Gold- / Silver-plated
casing with
integrated electronics
1. Illustration of the device
English

5
Programme sequence
(STEP 1 - 3)
Course of therapy in minutes
(1 - 7 min. per STEP)
Battery indicator is flashing:
Stop therapy and replace
battery
Button: I / GO
1. Turning on the device
(push button briefly)
3. Start therapy
(push button briefly)
(manual STEP selection)
4. Turning off the device
(push button for an extended period
of time or device will automatically
turn off after 30 seconds)
Button: TIME
2. Select number of minutes
(1 - 7 min.)
2. Control panel with functions
English

6
3. Description of the device
Intended use
The PowerTube®QuickZap®is intended for the electronic
stimulation of nerves. It is used for self-treatment of
symptoms and pain.
Its application does not replace treatment or instructions
from a doctor, but has a positive influence on symptoms and
pain.
Using the device can alleviate pain. Please refer to the
instruction manual for detailed information on the «intended
use».
Function designation
The transcutaneous electronic nerve stimulation device
PowerTube®QuickZap®is an easy to use, battery-operated
electronic device designed to stimulate the nerves.
Corresponding nerve points are stimulated directly with
electronic impulses. The device can be operated by persons
who do not have formal medical training.
The device is described in the enclosed easy to follow
instruction manual to make self-treatment a straightforward
process. The handling of the device is intended to suit users
with no medical training. Various applications as well as
corresponding therapy times are outlined in the instruction
manual.
4. Quick start guide
Before using for the first time
Immediately after receipt, the device should be inspected for
transport damages and be subject to a function test. In case
of transport damage, the shipper shall be notified immedia-
tely and a damage report be drawn up to support any claim
for damages. In addition to name and address of the
recipient, the protocol shall include the date of receipt, type
and serial number of the device as well as a description of
the damage. The original packaging should be kept during
the guarantee period to ensure that the device can be
returned in its original packaging if necessary.
English

7
5. Battery and battery compartment
Use alkaline batteries only and check the polarities (plus /
minus) carefully. By using this kind of battery you may be
certain to end your therapy time even in case the battery is
almost empty by showing the sign «low battery». The device
is adjusted to this type of batteries.
If you use rechargeable accus (e. g. NiMH), the proper
functioning of the sign «low battery» is not completely
reliable because of the different mode of discharging. The
device may abruptly stop functioning without prior warning. If
you still prefer to use rechargeable accus, please recharge
them periodically.
Every device is tested by the manufacturer in terms of
functionality and safety before being shipped. Please
observe the following to ensure that the device continues to
operate properly following transport and installation:
The operator should only start using the device
after carrying out a function test (see chapter
12).
English

8
6. Specifications
Display
Error messages
Battery IEC 6LR61 9-volt block battery
Output voltage AC max. 9-volt pp / min. 6-volt pp
Duration of treatment 3 - 21 minutes
Programme sequence 3 steps
Measurements Length 18 cm, diameter 3,1 cm
Weight ~ 1100 g
Application class BF
Safety class IIa unit
Graphic symbols
Typ BF
Production date month/year-serial number
Intermittent tone:
handholds or contact areas are not
applied properly
Continuous tone:
handholds have short circuited
Please refer to
instruction manual!
• Time of therapy in minutes
•7 light-emitting diodes
•Therapy steps 1 - 3
•Exchange light-emitting diode battery
IP protection class Device: IP40
Protection against entry of solid foreign
substances Ø > 1 mm, not protected
against water.
Case: IPX2
Protection against dripping water (tilted)
up to 15° relative to vertical line.
•5 °C - 40 °C
•humidity 15 % - 93 %, without cond.
•atm. pressure 700 hPa - 1060 hPa
Operation
•-25 °C - 70 °C
•humidity - 93 %, without cond.
•atm. pressure 700 hPa - 1060 hPa
Transport and
storage
English

9
7. Handling
Turning on the device: push I / GO button briefly.
Set appropriate therapy time per step by means of TIME
button. Start with 1 minute per step, i. e. the complete
treatment time is 3 minutes. Increase the time with every
treatment by 1 minute per step. Complete steps 1 and 2
(see below and beside) once a day.
Place device on trigger point.
Start treatment by pushing the I / GO button.
You will hear a beep signal after completion of every step.
The end of the treatment is announced with 2 beep
signals.
Turning off the device: push I / GO button for a prolonged
periode of time or device turns off automatically after 30
seconds.
1.
2.
3.
4.
5.
6.
7.
Error message:
Insufficient or no skin contact is indicated with
continuous beep signals.
Step 1
Local treatment at trigger point
English

10
Step 2
Treatment of abdominal area
Please ensure good body contact. Moisten skin with water if
necessary.
Consume large quantities of water before and after the
treatment.
Safety tips
10.
While operating in immediate vicinity of a short- or
microwave may lead to instability of the stimulator-output.
PowerTube®QuickZap®may only be used for the elctroni-
cal stimulation of nerves and musculature.
Do not use the device for patients who have been fitted
with a cardiac pacemaker.
Please note that risk of strangulation by cable because of
the excess length.
The application of electrodes in proximity of the thorax can
increase the risk of cardiac fibrillation.
Do not apply directly over the head, above the heart, on the
eyes, on the front of the neck (particular carotid sinus), on
the mouth, on the chest, on the upper back.
•
•
•
•
•
•
Pregnancy, cardiac pacemaker, open wounds and fresh
scars.
Do not use in combination with other devices.
•
•
Contraindications9.
Pain relief•
Indications8.
English

11
Care, maintenance and storage11.
Appropriate operation and maintenance.
Protection from moisture, high temperatures, dust and
direct sunlight.
Protection from children, animals and pests.
Wipe electrodes after every use to disinfect them.
Remove the battery if the device is not being used for a
prolonged period of time.
The expected life of new alkaline batteries amounts 2
months (daily duration of 20 minutes).
•
•
•
•
•
•
Effective protection of the PowerTube®QuickZap®from
damage includes:
Simultaneous use with other devices is prohibited.
PowerTube®QuickZap®may only be operated with a 9-volt
battery.
PowerTube®QuickZap®may only be operated with the
accessories included in the range of delievery.
Fritonex AG is only responsible for the reliability and safety
of PowerTube®QuickZap®if:
•
•
•
•
Please recycle the batteries in accordance with the
national regulations.
The expected life of the device, including parts and acces-
sories amounts 10 years.
PowerTube®QuickZap®should be disposed of as
hazardous waste.
For technical questions in connection with the handling, or
maintenance contact the manufacturer.
•
•
•
•
PowerTube®QuickZap®is operated in accordance with
the instruction manual,
expansions and modifications are carried out only by
persons who are authorised by FRITONEX AG.
•
•
English

12
Errors and malfunctions,
function test
12.
Discharge of the battery is displayed on a battery indicator
LED.
After being turned on, PowerTube®QuickZap®automatical-
ly runs a battery test.
An acoustic warning signal during therapy indicates that
the electrodes have not been properly applied.
•
•
•
Accessories13.
Hand electrode
Instruction manual
IEC 6LR61 9-volt battery
Portable case for PowerTube®QuickZap®
•
•
•
•
Guarantee14.
Device and accessories shall be inspected for transport
damage immediately after receipt. Corresponding claims for
damages can only be asserted if the vendor or shipper have
been notified immediately. A damage report shall be compi-
led.
The guarantee for PowerTube®QuickZap®is two years
from day of delievery.
The extent of guarantee includes free repair of the device,
provided the damage was caused by a material or
manufacturing error.
•
•
English

13
Additional claims, particularly claims for damages, are
excluded.
The repair may only be carried out by FRITONEX AG, one
of its agencies or authorised specialist dealers. The
guarantee shall become void if improper modifications or
repairs are carried out.
The guarantee period will neither be extended nor
renewed because of guarantee work.
FRITONEX AG reserves all rights to this instruction
manual, particularly the right of duplication and distribution
as well translation. No part of this instruction manual may
be copied or distributed in any form without prior written
consent from FRITONEX AG.
Information contained in this instruction manual may be
modified or upgraded by FRITONEX AG (updates can be
found on www.fritonex.ch).
•
•
•
•
•
Safety inspection15.
§ 6 of the directive on installing, operating and using active
medical products stipulates regular safety inspections to
guarantee the safety of the device against age, wear and
tear etc.
The operator is responsible for having these safety inspec-
tions carried out on the device to the prescribed extent and in
due time. Safety inspections may only be carried out by the
manufacturer or by explicitly authorised persons.
The following safety inspections are required for Power-
Tube®QuickZap®:
Examination of labelling and instruction manual
Visual inspection of device and accessories for damages
Function test of all sensors and control lamps on the
device
•
•
•
English

14
Conformity declaration
CE 0482
16.
We declare in the position as solely responsible company that:
the medical electrical
equipments
in safety class
Directives 93/42/EWG appendix V
Registration no. 7288DE414150310
Conformity of the quality
management system is
acknowledged and moni-
tored by
CH-Forst, 23-03-2015
Name and address
of the company FRITONEX AG Breite 9
CH-3636 Forst
Switzerland
PowerTube®QuickZap®gold
Typ FPT.B1
PowerTube®QuickZap®silver
Typ FPT-D.B2
according to appendix IX of the
directives 93/42/EWG
IIa
according to appendix IX of the
directives 93/42/CEE
all required standards of the directives mentioned in the medical
dispositions 93/42/EWG are herewith completely fulfilled and
adhered to.
Conformity evaluation
procedure
MEDCERT GmbH
Pilatuspool 2
D-20355 Hamburg
Deutschland
Martin Frischknecht
(CEO FRITONEX AG)
23. Januar 2020The period of validity of
the certificate
English

Instruction manual
PowerTube®QuickZap®
FRITONEX AG
Breite 9
CH-3636 Forst
Switzerland
Edition 2015-03-23
Printed in switzerland
© 2015 FRITONEXAG.All rights reserved.All trade names
are registered trademarks of