BOSANA Tipstim Glove User manual

High-tech therapy glove to be used in combination
with tipstim® pulse generator
INSTRUCTIONS FOR USE
For size & dexterity see information
on the label inside the glove
Manufacturer:

2instruction manual tipstim® glove
3rd edition, June 2016
This instruction manual contains copyright protected information of BOSANA Medizintechnik GmbH and
third parties. Each rendition or utilization outside of the borders permitted by copyright is inadmissible
without previous written permission on the part of BOSANA Medizintechnik GmbH. BOSANA Medizin-
technik GmbH reserves the right to make improvements and changes without prior notice. All data and
information is reviewed periodically and any changes applied will be implemented in the next available
version of the instruction manual.
TABLE OF CONTENT
Intended use and medical application areas 3
Explanation of graphic symbols and product marking 4
Safety instructions and warnings 5
Preparing a therapy session 10
During the therapy session 12
After the therapy session 12
Replacement of tipstim® glove after 100 therapy sessions 13
Storage and care 13
Technical information 13
Therapy recommendations and explanations 14
Troubleshooting 14
Environmental protection and waste disposal 15
Warranty 15

instruction manual tipstim® glove 3
IMPORTANT NOTE
PLEASE MAKE SURE TO READ ALL INFORMATION PROVIDED IN THIS
INSTRUCTION MANUAL AND IN THE INSTRUCTION MANUAL OF
TIPSTIM® PULSE GENERATOR. BEFORE USING TIPSTIM® GLOVE.
THIS INSTRUCTION MANUAL IS AN INTEGRAL PART OF THE MEDICAL
DEVICE. BE SURE TO ALWAYS KEEP IT WITH THE MEDICAL DEVICE.
Do not use the tipstim® glove if you do not fully understand any aspect of operating the
system. Please refer to a qualified supplier for assistance.
Intended use
tipstim® glove is a class I medical device.
It is intended for sensitive electrical stimulation of the finger tips and for tone regulation
in the treatment of spasticity of the upper extremities. tipstim® glove is intended for the
use in combination with tipstim® pulse generator only.
tipstim® glove is approved for single patient use only and
must must be replaced after 100 applications of 60 minutes each.
Medical application areas
tipstim® glove is approved for the treatment of patients suffering from incomplete
sensomotoric hemi- or monoparesis (paralysis) after stroke or craniocerebral trauma as
well as for the treatment of CRPS (Complex Regional Pain Syndrome type 1).

4instruction manual tipstim® glove
EXPLANATION OF GRAPHIC SYMBOLS
AND PRODUCT MARKING
Indicates a direct hazard carrying a high risk of death or
serious injury if not avoided.
Indicates a medium risk which could result in death or
serious injury if not avoided.
Indicates a possible danger that may result in minor or
moderate injury if not avoided.
Consult instruction manual
Manufacturer (see label inside glove)
Item number tipstim® glove (see label inside glove)
Stand JJJJ/MM last update status (see label inside glove)
LOT number (see label inside glove)
CE marking
Caution – follow the instructions
Protect medical device from moisture (IP 00 acc. to DIN EN 60529)
Keep medical device away from sunlight and from heat
Medical device not be disposed of with normal/household waste

instruction manual tipstim® glove 5
Not suitable for pacemaker wearers
Prevention of danger/risk
Temperature
Humidity
Air pressure
SAFETY INSTRUCTIONS AND WARNINGS
Possible risk of interference with cardiac pacemakers
tipstim® glove should not be used by patients fitted with a pacemaker.
Exception: explicit permission by a medical specialist.
Possible risk of danger to patients with cardiac damage
tipstim® glove should not be used by patients with cardiac damage.
Exception: explicit permission by a medical specialist.
Danger to children and untrained users
Keep away from Children and untrained users.
Possible risk of damage to implanted medical products
tipstim® glove should not be used by patients with medical implants.
Exception: explicit permission by a medical specialist.

6instruction manual tipstim® glove
Possibility of deviations in the output parameters by unauthorized
attempts to repair or to clean
Do not attempt to repair tipstim® glove. Do not wash, use bleach, iron, dry-clean
or tumble-dry tipstim® glove. Do not turn tipstim® glove inside out.
Risk of Deviations in the output parameters or electric shock caused
by liquid in the medical device
Do not expose the product to high humidity. Do not clean tipstim® glove with
water or other liquids. Not to be used outdoors.
Ignition of highly combustible substances
Always keep the product away from highly combustible materials.
Use by several patients
The use of tipstim® glove by more than one patient is PROHIBITED
Possible risk to health by painful stimulation pulses
tipstim® glove is approved for single patient use only and must be replaced after
100 applications of 60 minutes each.
Possible risk to health (heart, head, genitalia, spinal cord, neck) by electrical
stimulation
Only use tipstim® glove as per the instructions at all times.
Incorrect use of tipstim® can lead to possible damage to health
Only use tipstim® glove as per the instructions at all times and always keep
this instruction manual with the product.
Possible risk of danger by electric shock
Do not connect tipstim® glove or its components/accessories directly to mains
power supply. Always remove any kind of hand or finger decoration (e.g. rings)
before starting the therapy. Avoid strong hand and finger movements during
the therapy as this might lead to contact interruptions between fingers and
electrodes resulting in discomfort.

instruction manual tipstim® glove 7
Risk of burning the skin by high-frequency surgical unit at the
electrode contact point
Simultaneous connection to a surgical device with a high frequency can lead to
burning of the skin at the electrode contact points.
Combustible/explosive substances in the immediate surroundings could be ignited
Do not operate tipstim® glove close to combustible/explosive substances
or flames of any type.
To avoid deviations in the output parameters by environmental conditions
Observe the predefined operating and storage conditions at all times.
tipstim® glove to be protected from strong sunlight and
strong heat sources
tipstim® glove to be protected from moisture
(IP 00 acc. to DIN EN 60529)
tipstim® glove only to be operated at an ambient temperature
between 5°C and 35°C
tipstim® glove only to be operated at a relative humidity
of 30-75%
tipstim® glove only to be operated at a relative pressure
between 700-1060 hPa
tipstim® glove not to be used in dusty environment
Possible risk of infection for patients designated to use sterile products only
Do not use tipstim® glove if sterile environmental conditions are required.
Risk by uncontrolled actions
Do not use tipstim® glove with patients suffering from seizure disorders
(e.g. epilepsy), increased epileptogenity or severe cognitive impairments.
Exception: explicit permission by a medical specialist.

Risk by improper use
Only use tipstim® glove with accessories provided and in combination with
approved medical devices that are compatible with tipstim® glove.
Deviations in the output parameters
Do not operate tipstim® glove in the vicinity of therapeutic shortwave or
microwave devices as this will cause deviations in the output.
Pain or other health problems during treatment
Stop using the device immediately, consult a medical specialist and notify
the manufacturer without delay.
Danger of injury by damage to tipstim® glove or its accessories
Do not crush tipstim® glove. Avoid squeezing or pulling the connection cables.
Damaged parts must not be used.
Danger of injury by electrical shock when starting or ending therapy session
Switch on the associated tipstim® pulse generator only after tipstim® glove has
been put on and connected correctly. Always completely switch off the
associated tipstim® pulse generator before taking off tipstim® glove.
Tissue damage around conductive implants
Do not use tipstim® glove close to conductive implants.
Damage to surgical wounds, to injured skin and other skin irritations
Do not use tipstim® glove close to fresh surgical wounds or damaged skin.
Damage to health in case of infectious diseases and fever
Do not use tipstim® glove.
Danger of injury when operating machinery simultaneously
Do not use tipstim® glove.
Danger of injury by high electrical currents in case of sensitivity disorders
Talk to your medical specialist about which level of intensity to use.
8instruction manual tipstim® glove

Health impairments of stroke patients
Please make sure to use tipstim® glove 2 weeks after stroke at the earliest.
Health impairments of patients suffering from polyneuropathy or peripheral
nerve lesion in the region of the upper extremities
Do not use tipstim® glove
Impairment of the treatment success due to interaction caused by a
simultaneous therapy with anticonvulsants (drugs for the treatment of epilepsy)
tipstim® glove may only be used under medical supervision.
instruction manual tipstim® glove 9

PREPARING A THERAPY SESSION
Before starting the therapy:
■Before putting on tipstim® glove, please make sure that your hand to be treated is clean,
free of cream and dry.
■Always connect tipstim® glove to the tipstim® pulse generator.
To connect the tipstim® glove to the
tipstim® pulse generator:
■Connect the plug of the connection
cable to the socket (CH 1/2) at the
top of tipstim® pulse generator (see
figure 1).
■Fully connect the 3 metal pins of
the cable (found on other end) to the
3 snap adapters. Make sure there is
no visible metal of the pin on view
(see figure 2).
■Plug the 3 snap adapters to tipstim®
glove. Please follow the colour
sequence: red cable to button with
red background, black cable to black
button and yellow cable to yellow
button (see figure 3).
fig. 2
fig. 1
fig. 3
10 instruction manual tipstim® glove

■Put on tipstim® glove (see figure 4).
Make sure that the zip is located on
the back of the top of the hand. Do
not twist the fingers of tipstim®
glove (seams of tipstim® glove must
be located on either side of the
finger). Do not pull tipstim® glove
too strongly as this will damage the
electronic components inside
tipstim® glove. The zip at the back
of the hand allows one to put on
tipstim® glove more easily –
especially for those with spasticity.
■Make sure that all finger tips touch
the finger tops of tipstim® glove
and that the fingers fit closely. This is
important to ensure correct
stimulation of the finger tips.
If necessary readjust tipstim® glove
to the correct settings by using the
other hand (see figure 5).
■Read the instruction manual of
tipstim® pulse generator.
instruction manual tipstim® glove 11
fig. 4
fig. 5

12 instruction manual tipstim® glove
DURING THE THERAPY SESSION
■For best results keep your hand and fingers relaxed by laying the hand, for instance,
on a table. Do not move the hand during therapy. Strong hand/finger movements
may lead to a loss in electrode contact and as a result to an uneven stimulation.
Note: In case there is no current noticeable at the beginning or in the further course of the
therapy and intensity of tipstim® pulse generator cannot be increased (display is blinking
and shows 2 mA or less and cannot be increased, an acoustic signal is audible and will be
repeated after 30 sesconds) there is no sufficient contact between at least one finger and
the in-built electrodes. Please readjust tipstim® glove (see figures 4-5) to make sure that
you have a tight fit.
If the problem continues then the likely cause is that the skin is very dry leading to an
insufficient contact with the electrodes and so reducing the conductivity of tipstim® glove.
Soak your finger tips in clear water for about 1 minute before starting the therapy and let
your hand dry naturally. This process is generally suitable to improve conductivity. Repeat
this process in case the electrical contact should be disrupted again during therapy. Thera-
py can be paused and continued any time by pressing the "Pause“-button (see instruction
manual of tipstim® pulse generator). A short interruption of the therapy session has no
negative effect on the therapy results.
AFTER THE THERAPY SESSION
■Always turn off the tipstim® pulse generator before taking the tipstim® glove off.
■Gently pull off tipstim® glove.
■Always store tipstim® glove and tipstim® pulse generator in the packing provided.
■Take care not to bend the cables!
Note: It might be the case that, after having finished the therapy session, you still feel a
slight tingling sensation in your finger tips. This effect is harmless and will disappear after
some time.

instruction manual tipstim® glove 13
REPLACEMENT OF TIPSTIM GLOVE AFTER
100 THERAPY SESSIONS (60 MINUTES EACH)
If you want to change your tipstim® glove for a new one please observe the following
instructions:
■Loosen snap adapters carefully from tipstim® glove.
Take care not to tear the tipstim® glove.
■Do not pull the cable, prize the cables off gently.
■Connect the new tipstim® glove as described previously in the instruction manual.
STORAGE AND CARE
■Store tipstim® glove in a dry place.
■For cleaning follow the instructions on the label found on the inside of the
tipstim® glove: Do not wash, use bleach, iron, dry-clean or tumble-dry the
tipstim® glove.
■To protect the conductive material of tipstim® glove always wash hands before use.
Also make sure the hand is clean, dry and free of sweat. Do not use any hand creams or
lotions.
■Do not turn tipstim® glove inside out.
TECHNICAL INFORMATION
All textiles and yarns used for the manufacturing of tipstim® glove meet the Oeko-Tex 100
standard.
Material: 85% Polyamid, 15% Elasthan
Inlay: 100% PET
Electrode: 94% Polyamid, 6% Dorlastan
Pad: 100% Polyester

THERAPY RECOMMENDATIONS
AND EXPLANATIONS
■Daily therapy times
Unless otherwise recommended by the medical expert therapy should be performed for
1 hour every day.
■Total therapy time
Therapy time in weeks/months will be defined by your medical expert and depends on
your desease’s severity, the elapsed time since the origin of your desease and your
individual therapeutic progress.
■General notes
Since the hand is supplied by different nerves, fingers show a varying sensitivity. For this
reason tipstim® pulse generator offers 2 different channels allowing an individual
adaptation of the current intensity.
You should feel a relatively even and clear perception of the stimulation at all 5 fingers,
however, stimulation must not be unpleasant or painful. For further information please refer
to the instruction manual of tipstim® pulse generator. In everyday therapy the intensity
used for channel 1 (left channel) of tipstim® pulse generator (stimulating thumb, forefinger,
middle finger) will generally be higher than the one chosen for channel 2 (right channel:
ringfinger, little finger).
Please note that there is no default or standard value for the current intensity. This may vary
from patient to patient and day to day depending on such factors as electrical resistance of
the skin, environmental conditions etc.
TROUBLESHOOTING
■First read the instruction manual of tipstim® pulse generator (Debugging and repair by
untrained users)
■It may occur (very rarely) that your skin is too dry for a sufficient contact with the
in-built electrodes (display is blinking and shows 2 mA or less and cannot be increased,
an acoustic signal is audible and will be repeated after 30 seconds).
To solve this problem soak your finger tips in clear water for about 1 minute and start
the therapy again.
■If the fault should reoccur, please contact the manufacturer/supplier or your treating
physician/therapist.
14 instruction manual tipstim® glove

ENVIRONMENTAL PROTECTION
AND WASTE DISPOSAL
tipstim® is not to be disposed of with normal/household waste. Only dispose
using a reputable recycling company or return the device to the supplier.
Please obey your local regulations regarding disposal..
WARRANTY
For tipstim® glove, the legal warranty or a warranty for the operating life of tipstim® glove
stipulated by the manufacturer shall apply - whatever occurs first. The warranty claim is
not applicable for defects, failures or damages which derive from noncompliance with this
the instruction manual as stated in this manual and/or non-compliance with the medical
expert’s instructions. The warranty does not apply in the event of accidents, misuse and
interventions and changes performed by non-authorized personnel.
Should you experience any problem with the medical device or its components please refer
to the manufacturer or your local dealer.
We wish you a successful course of therapy!
instruction manual tipstim® glove 15

BOSANA Medizintechnik GmbH
Kappusstiege 13
D-46282 Dorsten (Germany)
Phone: [phone]
Fax: [phone]
Mail: [email protected]
www.bosana.de
Manufacturer:
Version no. 06-2016
For further information please visit www.tipstim.com