HYBRESIS 199586 User manual

READ THE HYBRESIS CONTROLLER AND PATCH INSTRUCTIONS FOR USE FOR
ADDITIONAL IMPORTANT INFORMATION.
REF: 199586
Charging Station - Instructions For Use

GLOSSARY OF SYMBOLS
This device may contain one or all of the following symbols:
Refer to Instruction Manual/Booklet
Council Directive 2002/96/EC concerning Waste Electrical and Electronic Equipment (WEEE). Indicates a
requirement not to dispose of WEEE as municipal waste. Contact your local distributor for information
regarding disposal of the unit and accessories.
Dangerous Voltage
Underwriters Laboratories, Inc., indicates product meets US and Canadian product safety standards.
This device complies with UL 60601-1 and CSA C22.2 No. 601-1-M90
Precautionary Instructions
Keep Dry
Keep Away from Sunlight
Class II Equipment
For Prescription Only
11N1

Warnings
• Keep out of the reach of children.
• Electronic monitoring equipment (such as ECG monitors and alarms) may not operate properly when this equipment
is in use.
• Electrodes should be removed before using equipment that generates high frequency or high energy electromagnetic
radiation such as welding equipment, surgical electrocautery units, shortwave and microwave therapy. Operation in
close proximity (< 3m) to this equipment may startle the user by causing output instability or improper operation of
the stimulator. Simultaneous connection to the patient may result in burns and possible damage to the stimulator.
• Care must be taken when operating this equipment adjacent to or stacked with other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference
by not using other equipment in conjunction with it.
• Do not operate these units in an environment where other devices are being used that intentionally radiate
electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect
Medical Electrical Equipment.
• This unit generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. Harmful interference to other devices can be determined
by turning this equipment on and off. Try to correct the interference using one or more of the following: reorient or
relocate the receiving device, increase the separation between the equipment, connect the equipment to an outlet
on a different circuit from that to which the other device(s) are connected or consult the Empi Repair Department for help.
• The system is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous
oxide.
• Use only accessories that are specially designed for this unit and recommended by Empi. The use of other accessories
or cables may result in increased emissions or decreased immunity of this unit.
• Avoid exposure to water. Do not allow the charging station to be immersed in fluids.
Precautions
1

DESCRIPTION
The Hybresis Charging Station is designed to charge and store Hybresis
Controllers.
OPERATION
The Hybresis Charging Station charges up to four Hybresis Controllers,
maintains them in a fully charged state and provides a convenient place
for storage.
General -
When a Controller is inserted into one of the charging bays, the Charging
Station will automatically detect the battery level of the Controller and
will begin to charge it.
2

Light Status Corrective Action
Green Charge Complete;
The Controller is fully charged
and ready for use.
None Required
Yellow Charging;
The Controller is charging
normally.
None Required
Red-
Continuous
or Flashing
Charging Fault;
Controller battery not charging
properly.
Return Controller to
Empi for service
Charging Station Lights -
The two windows on each of the charging bays indicate the following:
On rare occasions, the problem may be due to a defective Charger. If you have
another Controller, please charge it to determine if the Charger is functioning
correctly or not. If the same problem occurs with multiple Controllers, then
the Charger may be defective. 3

Charging Station Specications
Voltage Requirement 100 – 240 VAC @ 50 – 60 Hz
Current Requirement 0.125 A maximum
Environmental Storage Temperature 5° - 40° C (41° – 104° F)
Conditions
DO NOT expose to temperatures
above 50° C (122° F)
Operating Temperature 15° – 30° C (59° – 86° F)
Ingress of Not protected against ingress
Water of water, IPX0
Dimensions 8.5 cm H x 15 cm W x 12.5 cm L
Weight 421g
Class II
Continuous Operation
4

Guidance and manufacturer’s declaration – electromagnetic emissions
The Hybresis Charging Station is intended for use in the electromagnetic environment specified below. The
customer or the user of the Hybresis Charging Station should assure that it is used in such an environment.
Emission tests Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1 The Hybresis Charging Station uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment
RF emissions
CISPR 11
Class A The Hybresis Charging Station is
suitable for use in all
establishments, including
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
IEC 61000-3-3
Complies
5

Guidance and manufacturer’s declaration – electromagnetic immunity
The Hybresis Charging Station is intended for use in the electromagnetic environment specified below. The
customer or the user of the Hybresis Charging Station should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply
lines
±1kV for input/output
lines
±2kV for power supply
lines
±1kV for input/output
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV differential mode
±2kV common mode
±1kV differential mode
±2kV common mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0,5
cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5 sec
<5% UT
(>95% dip in UT) for 0,5
cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the Hybresis Charging
Station requires
continued operation
during power mains
interruptions, it is
recommended that the
Hybresis Charging Station
be powered from an
uninterrupted power
supply or a battery.
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
NOTE UTis the a.c mains voltage prior to application of the test level.
6

Guidance and manufacturer’s declaration – electromagnetic immunity
The Hybresis Charging Station is intended for use in the electromagnetic environment specified below. The
customer or the user of the Hybresis Charging Station should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment -
guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Hybresis Charging
Station, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V d= [3,5]√P
V1
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m d= [3,5]√P80 MHz to 800 MHz
E1
d= [7]√P800 MHz to 2,5 GHz
E1
where Pis the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and dis
the recommended separation
distance in met (m).ers
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site surveya,
should be less than the
compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
Hybresis Charging Station is used exceeds the applicable RF compliance level above, the Hybresis Charging
Station should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Hybresis Charging Station.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
7

Recommended separation distances between portable and mobile RF communications equipment
and the Hybresis Charging Station
The Hybresis Charging Station is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Hybresis Charging Station can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Hybresis Charging Station as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d= [3,5]√P
V1
80 MHz to 800 MHz
d= [3,5]√P
E1
800 MHz to 2,5 GHz
d= [7]√P
E1
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
din meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
8

Service
For clinical questions, contact the Professional Services Department at 1-800-328-2536
ext. 8506. If any component of the Hybresis System is not functioning properly or requires
servicing, contact the Empi Repair Department at 1-800-862-2343.
When returning any products, please include your name, address, phone number and a
description of the problem.
Return to:
Empi
Attn: Repair Department
47492 SD Hwy 22
Clear Lake, SD 57226
Repair and Maintenance
There are no user serviceable parts inside the Charging Station. If the station appears to be
non-functional, contact your Authorized Empi Distributor, or contact Empi directly.
Clean the case as needed with a damp cloth.
Do not immerse in uids.
9

Ordering
Order Number Description
199586 Hybresis Charging Station
199587 Hybresis Controller
199589 Hybresis Patch
Limited Warranty
I. Warning
While, in the opinion of Empi (“Empi”), the use of the Hybresis System (the “Product”) has
met with some success, Empi makes no warranties to the purchaser as to the effectiveness
of the product.
10

II. Warranty
A. Empi warrants to the initial Purchaser (“Purchaser”) (and to no other person) that the
Product (with the exclusion of accessories) and the component parts thereof, distributed
or manufactured by Empi, shall be free from defects in the workmanship and materials for
three years from the initial date of purchase from Empi (the “Warranty Period”).
B. The patches are excluded from the Warranty and sold “AS IS” because their structure is
such that they may be easily damaged before or during use.
III. Limitation of Liabilities and Disclaimer of Warranties
A. Empi’s sole obligation in the case of any breach of its warranties set forth in Paragraph
IIA above, shall be, at Empi’s option, to repair or replace the Product without charge to
Purchaser or to refund the purchase price of the Product. In order to recover under this
Warranty, Purchaser must send Empi written notice of the defect (setting forth the problem
in reasonable detail) prior to expiration of the Warranty Period, and within 30 days of
discovery of the defect. Upon Empi’s written request and authorization, Purchaser shall
return the Product to Empi, freight and insurance prepaid, for inspection.
11

Notice and return shipment shall be sent to Empi at 47492 SD Hwy. 22, Clear Lake, South
Dakota 57226, USA, or to an Empi Authorized Service Center. To locate the appropriate
service center outside of North America, or to request shipment approval, contact
Empi directly. Empi will not be responsible for damage due to improper packaging or
shipment. If Empi determines in its sole reasonable discretion that the Product contains
defective workmanship or materials, Empi will refund to the Purchaser, the purchase
price for the defective product, or return the repaired Product or a replacement thereof to
Purchaser, the purchase price for the defective product, or return the repaired Product or
a replacement thereof to Purchaser, freight and insurance prepaid, as soon as reasonably
possible following receipt of the Product by Empi. If Empi determines in its sole reasonable
discretion that the Product does not contain defective workmanship or materials, Empi
will return the Product to the Purchaser, freight and insurance billed to the Purchaser.
B. This Warranty is voided immediately as to any Product which has been repaired or
modified by any person other than authorized employees or agents of Empi or which has
been subjected to misuse, abuse, neglect, damage in transit, accident or negligence.
C. EXCEPT AS PROVIDED IN PARAGRAPH IIA, THE PRODUCT IS BEING SOLD ON AN “AS IS”
BASIS, ALL ACCESSORIES ARE SOLD “AS IS”, AND THE ENTIRE RISK AS TO THE QUALITY AND
PERFORMANCE OF THE PRODUCT IS WITH PURCHASER. THE WARRANTY PROVIDED IN
PARAGRAPH IIA IS INTENDED SOLELY FOR THE BENEFIT OF THE INITIAL PURCHASER AND
EMPI DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING, BUT NOT
12

LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE; PROVIDED, HOWEVER, THAT NOTWITHSTANDING THE FOREGOING
SENTENCE, IN THE EVENT AN IMPLIED WARRANTY IS DETERMINED TO EXIST, THE PERIOD
FOR PERFORMANCE BY EMPI THEREUNDER SHALL BE LIMITED TO THE LIFETIME OF THE
INITIAL PURCHASER. NO EMPLOYEE, REPRESENTATIVE OR AGENT OF EMPI HAS ANY
AUTHORITY TO BIND EMPI TO ANY AFFIRMATION, REPRESENTATION OR WARRANTY
EXCEPT AS STATED IN THIS WRITTEN WARRANTY POLICY.
(This Warranty gives Purchaser specific legal rights and Purchaser may also have other
rights which vary from state to state. Some states do not allow limitations of how long an
implied warranty lasts, so the above limitation may not apply to the Purchaser.)
D. EMPI SHALL NOT BE LIABLE TO ANY PERSON FOR ANY DIRECT, INDIRECT, SPECIAL,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES, LOST PROFITS OR MEDICAL EXPENSES
CAUSED BY ANY DEFECT, FAILURE, MALFUNCTION OR OTHERWISE OF THE PRODUCT,
REGARDLESS OF THE FORM IN WHICH ANY LEGAL OR EQUITABLE ACTION MAY BE
BROUGHT AGAINST EMPI (E.G. CONTRACT, NEGLIGENCE OR OTHERWISE) THE REMEDY
PROVIDED IN PARAGRAPH IIIA ABOVE SHALL CONSTITUTE PURCHASER’S SOLE REMEDY.
IN NO EVENT SHALL EMPI’S LIABILITY UNDER ANY CAUSE OF ACTION RELATING TO THE
PRODUCT EXCEED THE PURCHASE PRICE OF THE PRODUCT.
(This Warranty gives Purchaser specific legal rights and Purchaser may also have other
rights which vary from state to state. Some states do not allow the exclusion or limitation
of incidental or consequential damages, so the above limitation may not apply to the
Purchaser.)
13

205 Hwy 22 East
Clear Lake, SD 57226
651.415.9000
800.328.2536
360354 Rev. C, © 2007, 2010, Empi 1/10