Game ready GRPro 2.1 User manual

This User’s Manual is also available online in
English, French, German, Italian, Japanese, and Spanish
at www.gameready.com under Products.
MODEL NUMBERS
550550-03, 550550-03-RN, 550550-53
GRPro
™
2.1 CONTROL UNIT
User’s Manual

THE GAME READY DIFFERENCE
THE GAME READY DIFFERENCE
Game Ready®was built upon the concept that the principles behind spacesuit
technology could be used to develop an injury treatment system. As a designer for
the National Aeronautics and Space Administration (NASA) and an inductee into the
U.S. Space Foundation’s Hall of Fame, our founder helped pioneer the technology
involved in controlling pressure and temperature within a flexible garment. In 1998,
Game Ready began working with athletes, athletic trainers, doctors, and engineers to
expand breakthrough discoveries into the realm of sports medicine.
REGISTER YOUR PRODUCT
Please complete your Warranty Registration for both the GRPro
™
2.1 Control Unit and
the Wraps online at www.gameready.com. The Wrap registration card is packaged
with the Heat Exchanger of each Wrap. You must register within 30 days from the
date of purchase in order to receive warranty service. Further warranty information
can be found in the Warranty Section.
Let us know what you think of our products by calling us at the numbers below
or emailing us at [e-mail]. We’d love to hear from you.
Brought to you by CoolSystems, Inc.
1800 Sutter Street, Suite 500
Concord, CA 94520
In the United States call toll-free:
1.888.GameReady (1.888.426.3732)
Outside of the United States:
+1.510.868.2100
www.gameready.com

Sleep
TimeTime
RunIce
Bath
Temp.
Pressure
Off LowMedHigh
Avg.
Wrap
Temp.
55/13
50/10
45/7
40/5
ºF/ºC
DESCRIPTION OF THE GR PRO 2.1 SYSTEM
The following items are included in your GRPro
™
2.1 System:
A Wrap (comprised of an inner
ATX Series Heat Exchanger
and an outer Sleeve) must be
attached to the System to begin
treatment. Each Wrap is sold
separately and is not included
in the System.
Power Cord
AC Adapter
Connector
Hose
GRPro 2.1
Control Unit
Welcome Packet
(containing the
User’s Manual and
other information
about your System)
COLDEST
Sleep
Time Time
Run
Pressure Off Low MedHigh
55/13
50/10
45/7
40/5
ºF/ºC
Actual
Temperature
Target
Temperature
Wrap
(sold separately)
™Series
Heat Exchanger
Sleeve
Power
Volume
Pressure Backlight
Power
Indicator
Pressure
Indicator
Actual
Temperature
Temperature
Knob
Target
Temperature
Subtract
Time
Add
Time
C/F(Celsius/Fahrenheit)
(Manual Mode)
Program
Play/
Pause

Detailed Instructions for Use ________________________________ 2
Modes of Operation _____________________________________ 2
Buttons ________________________________________________ 2
Adjusting Temperature __________________________________ 3
Display _________________________________________________ 3
Operating the System ___________________________________ 5
Storage ____________________________________________________ 8
Cleaning ___________________________________________________ 9
Maintenance _______________________________________________ 10
Accessories ________________________________________________ 11
Indications for Use__________________________________________ 11
Contraindications ___________________________________________ 12
General Warnings and Cautions ____________________________ 12
Specifications ______________________________________________ 13
UL Classification ___________________________________________ 14
Electromagnetic Compatibility _______________________________ 15
Troubleshooting ___________________________________________ 19
Warranty __________________________________________________ 22
TABLE OF CONTENTS

Do not use this device without your physician’s specific recommendations for the frequency
and duration of your treatments.
The most common recommendation is to use cold therapy at least 4 times a day, for approximately
30 minutes each time, with at least a 30-minute break between treatments. While the
temperature is adjustable, it is reported that the greatest benefit from cold therapy is in the
40-60°F (4.5-15.5°C) temperature range. Generally reported compression recommendations
are for “None” to “Low” pressure settings during the first 24-48 hours after surgery or
injury, increasing to “Medium” or “High” only if it is comfortable after the first 48 hours.
We recommend that “High” pressure is never applied if you are confined to bed.
Be sure to read further safety warnings on pages 12-13 of this User’s Manual.
MODES OF OPERATION
Manual Mode: The System automatically starts in this mode, and allows the user to
adjust treatment time and pressure settings.
Program Mode: This mode allows the user to choose one of six treatment programs that
provide therapy for a set time then sleep (no treatment) for a set time, continuously, at a
specific pressure setting.
Drain Mode: Allows a user to connect a Hose with a special Hose Adapter (purchased
separately) to the unit, enter Drain Mode and have the unit empty the water out of the ice
box through the Hose. Drain Mode can be accessed by pressing the program key and
toggling through all six programs. To empty water in the System while in Drain Mode, press
the program key until you reach Drain Mode, attach the Hose Adapter to the Connector Hose,
place the Hose Adapter over a sink, and press the Play button. Drain Mode
will run the Control Unit’s fluid pump for up to six minutes (long enough
to fully empty the ice box). Drain Mode is indicated by the following icons:
DETAILED INSTRUCTIONS FOR USE
BUTTONS
Power: Use this button to turn the Control Unit on and off.
Program: Use this button to select one of the available Programs or to return to
Manual Mode. See page 8 in this manual for more information on Programs.
Play/Pause: Use this button to start or pause a treatment.
Add Time: Use this button to add time in Manual Mode (does not work in Program
Mode). You can add up to 90 minutes. Treatment must be paused in order to add
or subtract time.
Subtract Time: Use this button to reduce time in Manual Mode (does not work in
Program Mode). You can subtract up to 90 minutes. Treatment must be paused in
order to add or subtract time.
Pressure Selection: Use this button to select one of four pressure settings: No
Pressure, Low Pressure (5-15 mmHg), Medium Pressure (5-50 mmHg), and High
Pressure (5-75 mmHg). Pressure selection is not available in Program Mode.
Treatment must be paused to change pressure settings.
Volume: Use this button to select the option of sound or no sound. Push to mute
sound. Alarms will still sound even with Volume off.
C/F Button: Use this button to select either Celsius or Fahrenheit on the
temperature display.
Backlight: Use this button to turn the backlight on or off.
EN-2

ADJUSTING TEMPERATURE
To adjust the temperature being applied during treatment, simply turn the temperature
knob towards 3 snowflakes for the maximum amount of cold, or towards 1 snowflake for
the least amount of cold. Notice that as you adjust the knob, the “Target Temperature” on
the display will change. The System will automatically adjust to match the temperature you
have selected.
TIP: The maximum amount of cold is dictated by the amount of ice in the reservoir and the
setting of the temperature adjustment knob. You may need to stir or replenish the ice to
achieve coldest temperatures. Ice will melt faster in the acute phases of injury as the Game
Ready System is removing greater amounts of heat from the treatment site.
DISPLAY
Status bar: Off (Mute)
On
Indicates selected mode.
Indicates unit is paused.
Indicates unit is running.
Other Icons: Error
Sleep
Battery
Indicates an error. See troubleshooting
pages 19-21 for error codes.
Indicates sleep mode time.
Indicates remaining battery capacity.
Temperature: Actual Temperature: Approximate
temperature of the water leaving the Control
Unit.
Target Temperature: Indicates the target
temperature setting. The Control Unit will
automatically match the Actual Temperature
and Target Temperature as closely as possible.
EN-3

Pressure:
Off Low Med High
Off Low Med High
Off Low Med High
Off Low Med High
When selecting a
program:
Sleep
Time Time
Run
Pressure OffLowMedHigh
55/13
50/10
45/7
40/5
ºF/ºC
Target
Temperature
Actual
Temperature
Displays pressure.
Displays amount of
time unit will run.
Displays amount of
time unit will sleep.
When the System
is running in
Program Mode:
Displays the amount of run time
remaining.
Run time count-down bars.
Displays the amount of sleep time
remaining.
When the System
is running in
Manual Mode:
Displays the amount of run time
remaining.
Sleep time
count-down bars.
EN-4

OPERATING THE SYSTEM
To operate your GRPro 2.1 System, you need:
•Control Unit filled with ice and water as indicated by the fill line labels within the
reservoir. Optimal performance is achieved by first adding 1.5 liters of water, and then
filling the reservoir to the top with ice.
•Game Ready supplied power supply.
•Connector Hose.
•Wrap (includes a Heat Exchanger and Sleeve).
Notes:
•The Wrap is comprised of an inner Heat Exchanger and an outer Sleeve. The combination
of Sleeve and Heat Exchanger is referred to throughout this manual as a “Wrap.” To ensure
proper performance, be sure to use ATX Series Heat Exchangers.
•The GRPro 2.1 Control Unit should be placed on a stable surface (such as the floor or a
table) during use.
•Note that using the System in an environment with a high ambient temperature may
affect its ability to provide adequate cooling, or may limit the ice life.
•If you will be using the System with a Game Ready optional battery pack (sold separately),
please consult the instructions for use that accompany that battery pack.
Warning:
•Your GRPro 2.1 Control Unit should be plugged into a grounded electrical outlet prior to
operation.
•Position the Control Unit to minimize the risk of tripping over the Control Unit, Connector
Hose, or power cord.
Precautions:
•Failure to properly follow the instructions of this manual and those of your medical
provider may interfere with or prevent delivery of appropriate therapy.
•To avoid risk of electrical shock unplug the Control Unit from the electrical outlet prior to
filling the Control Unit with ice and water.
1Push the door release button to open the ice box door.
EN-5

4Place the Control Unit in the location where you plan to use it. The Control Unit should
only be used in the upright orientation as shown. The Control Unit will leak if placed on
its side.
2Add water to fill-line indicated on label within the reservoir. DO NOT OVERFILL. Add
ice to top of reservoir.
3Close the ice box door. Make sure you hear it click.
Click
EN-6
5Connect the AC Adapter to the receptacle on the end panel of the Control Unit, then
plug the AC Adapter into a grounded electrical outlet. The power indicator light (orange
color) on the Control Unit should illuminate. Press the power button. The screen
should light up and the Control Unit should beep twice. The power indicator light
should turn from orange to
green. If you do not see these
indicators, refer to “Control
Unit will not turn on” on page
21 of the Troubleshooting
Guide in this manual.
Note: The Control Unit should
be turned on prior to attaching
a Wrap.
AC Adapter
to electrical outlet

6Connect the larger end of the
Connector Hose (with the red
button) to the Control Unit.
Make sure you hear it click.
To disconnect, simply press
the red button and remove
the connector from the
Control Unit.
7Apply the selected Wrap (consult the Use Guide accompanying each Wrap for
application instructions). To ensure proper performance of the System, it is important
to use ATX Series Heat Exchangers in your Wrap.
Caution:
•The Wrap is not sterile. Do not place directly against open wounds, sores,
rashes, infections, or stitches. The Wrap may be applied over clothing or
dressing.
•To ensure best fit, be sure the Wrap is completely deflated prior to each
application.
If you have any problems with the set-up of your GRPro 2.1 System, in the U.S. call
Game Ready Customer Service at 1.888.426.3732 (+1.510.868.2100); from outside
of the U.S. please contact your local distributor.
Warnings:
•Follow the treatment recommendations of your health care practitioner
for the use of this device.
•Improper placement or prolonged use of the GRPro 2.1 could result in tissue
damage.
•For additional warnings and precautions, please refer to pages 12 & 13
of this manual.
8Connect the smaller end of the Connector Hose (with a blue or gray button) to the
Wrap. Make sure you hear it click. To disconnect, simply press the blue or gray button
and remove the connector from the Wrap.
9Set your target temperature (displayed in the Target Temperature window) by
turning the knob. Turning the knob clockwise, towards 3 snowflakes, will
provide more cold therapy. Turning the knob counter-clockwise, towards 1
snowflake, will provide less cold therapy.
Disconnect
Button
Connector Hose to Wrap
EN-7
Disconnect Button
Click

Manual Mode:
Set the time in five minute increments by pushing the +/- buttons.
Set the pressure by pushing the pressure button. You can select
from 4 pressure settings: No pressure, Low Pressure (5-15mmHg),
(Medium Pressure (5-50mmHg), High Pressure (5-75mmHg).
Program Mode:
Push the program button to enter Program Mode. In Program Mode,
the unit will operate continuously according to the selected program.
You will need to replenish ice and water as previously indicated in
step 2.
You can select from the following programs: (Push the Program
Button to scroll through the available programs.)
Program 1: 30 minutes on, 30 minutes sleep. No pressure.
Program 2: 30 minutes on, 30 minutes sleep. Low pressure.
Program 3: 30 minutes on, 30 minutes sleep. Medium pressure.
Program 4: 30 minutes on, 60 minutes sleep. No pressure.
Program 5: 30 minutes on, 60 minutes sleep. Low pressure.
Program 6: 30 minutes on, 60 minutes sleep. Medium pressure.
Program d: Drain Mode. Please refer to page 2 in this manual for
details.
10 You can choose to operate in either Manual Mode or Program Mode.
Manual Mode allows you to adjust time and pressure settings as you
choose. Program Mode allows you to choose one of six programs that
provide treatment for a set time then sleep (providing no treatment) for a set time,
continuously, at a specific pressure setting (refer to list of available programs below).
The unit automatically starts in Manual Mode.
STORAGE
When you are done using the System for the day:
•Unplug the AC Adapter and the Connector Hose from the Control Unit.
•Push the door release button to open the door.
•Carefully pour out the ice and water.
•Wipe off any excess water.
•Store the Control Unit with the lid fully open to allow the interior to dry and preserve
the reservoir seal. Store the Control Unit in the Carry Bag or in another safe location.
Remember that your GRPro 2.1 Control Unit is a valuable piece of equipment and should
be treated with great care, like a laptop computer.
Storage Temperature Conditions: 33° - 120°F (1° - 50°C)
Relative Humidity: 10% - 95% non-condensing
Caution: Do not keep in extreme cold or hot temperatures (below 33°F or above 120°F
or below 1° or above 50°C). Do not leave in a hot or freezing car. Do not leave the Control
Unit in direct sunlight. The UV light may damage or discolor the Control Unit.
EN-8

CONTROL UNIT
The exterior of the Control Unit and the visible interior surfaces of the reservoir can be
cleaned with a soft cloth and one of the following cleaning agents:
•Mild detergent
•70% Isopropyl alcohol
•100% Simple Green®
•Quaternary ammonium (such as Virex®– typically only found in a clinical use setting)
•Cavicide®
Procedure:
•Follow the manufacturer’s instructions and precautions for the cleaning agent you select.
•Apply the selected cleaner to a soft cloth and wipe down all surfaces of the Control Unit.
•Allow the Control Unit to dry thoroughly before storing it in the bag.
•The Control Unit should be cleaned as needed.
DO NOT USE:
•Phenolic-based disinfectants (such as Amphyl®– typically only found in a clinical use
setting).
•Any solvent-based cleaners on the Control Unit. Doing so will damage the plastics and
will void your warranty.
•Abrasive materials to clean the Control Unit. Doing so will damage the plastics and will
void your warranty.
Caution: The Control Unit is not a waterproof device. Do not apply a direct stream of any
liquid onto the Control Unit, submerge the Control Unit, or allow any liquid to pool on the
surface of the front panel of the Control Unit.
CONNECTOR HOSE
The surface of the Connector Hose can be cleaned using a soft cloth and one of the
following:
•Mild detergent
•Steri-Fab®
•70% Isopropyl alcohol
•We do not recommend the use of quaternary ammonium (such as Virex®) or Cavicide.
®
DO NOT USE:
•Phenolic-based disinfectants (such as Amphyl®– typically only found in a clinical use
setting).
•Any solvent based cleaners. Doing so will damage the plastics and will void your
warranty.
•Abrasive materials. Doing so will damage the plastics and will void your warranty.
•Any petroleum based lubricants. Doing so will damage the o-rings and will void your
warranty. If lubrication is required, the use of silicon spray is recommended.
WRAPS
Gently remove Heat Exchanger from the Sleeve. Hand wash the Sleeve in cold water,
using a mild detergent or antibacterial soap. Do not use fabric softener. Hang to dry.
If needed, the external surface of the Heat Exchanger may be cleaned by wiping down with
commercial non-bleach cleaning wipes or hand washed using a very small amount of mild
detergent or antibacterial soap. DO NOT MACHINE WASH.
Refer to the Wrap Use Guide accompanying individual Wraps for more information.
CLEANING
EN-9

MAINTENANCE
The reservoir filter should be inspected, cleaned, and/or replaced as necessary.
1Identify the filter within
the ice reservoir.
2Using two fingers, grasp
and squeeze the two
protruding prongs.
3Slide the filter out.
4Rinse debris from the
filter and be sure there
are no obvious signs of
damage.
If you have questions
or would like to order
a new filter, in the
U.S. call Game Ready
Customer Service at
1.888.426.3732
(+1.510.868.2100);
from outside of the
U.S. please contact
your local distributor.
5
To replace the filter, or install
a new filter, first ensure that
the filter is oriented properly
with the plastic tab facing
up. If the filter is not oriented
properly, the protruding tab
will prevent the filter from
sliding back into place.
6You will feel and
hear the filter snap
back into place.
CARRY BAG
The Carry Bag should be cleaned using a soft cloth or brush and a mild detergent. Febreze®
or the equivalent can be used on the Bag if desired. If the Carry Bag has a biological material
on the surface, Steri-Fab®may be used to decontaminate those surfaces.
Be sure to test any product on a small portion of the Bag to ensure that it will not cause
damage.
Note: To operate the GRPro 2.1 System, you do not need to remove it from the Carry Bag.
Simply unzip the Bag’s main compartment and end panel. Fill the reservoir with ice and
water. Attach the Connector Hose and the AC Adapter to the end panel of the Control Unit
and plug the AC Adapter into a grounded electrical outlet.
EN-10

The GRPro 2.1 Control Unit can be used with any of the following accessories:
•Any Game Ready Wrap using ATX Series Heat Exchangers (wraps made by any other
manufacturer CANNOT be used with this System)
•Game Ready supplied FSP Group, Inc. Power Supply model FSP 030-RCAM and Hospital
Grade Power Cord
•Game Ready supplied Connector Hose
•Game Ready Carry Bag
•Game Ready Drain Mode Adapter
ACCESSORIES
Caution: United States Federal Law restricts this device to sale by or on the order of
a licensed health care practitioner.
•Follow the treatment recommendations of your health care practitioner for duration and
frequency of use for this device.
The GRPro 2.1 System combines cold and compression therapies. It is intended to
treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold
and compression are indicated. It is intended to be used by or on the order of licensed
healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home
settings.
INDICATIONS FOR USE
Other than maintaining the reservoir filter, no product service should be performed by
the user. If your GRPro 2.1 System requires service, in the U.S. call Game Ready
Customer Service at 1.888.426.3732 (+1.510.868.2100); from outside of the U.S. please
contact your local distributor.
EN-11

Compression Therapy (vasopneumatic compression) using the Game Ready System or any
compression therapy device should not be used in patients:
•Who are in the acute stages of inflammatory phlebitis in the affected region.
•Who have any history or current clinical signs suggestive of deep vein thrombosis or
pulmonary embolus in the affected region (to be treated with this therapy).
•
Who have significant arteriosclerosis or other vascular ischemic disease in the affected region.
•Who have a condition in which increased venous or lymphatic return is not desired in the
affected extremity (e.g., carcinoma).
•Who have decompensated hypertonia in the affected region.
Cryotherapy using the Game Ready System or any cryotherapy device should not be used
in patients:
•Who have significant vascular impairment in the affected region (e.g., from prior
frostbite, diabetes, arteriosclerosis or ischemia).
•Who have known hematological dyscrasias which affect thrombosis (e.g., paroxysmal
cold hemoglobinuria, cryoglobulinemia, sickle-cell disease, serum cold agglutinins).
CONTRAINDICATIONS
GENERAL WARNINGS AND CAUTIONS
WARNINGS
•Improper placement or prolonged use of the Game Ready System could result in tissue
damage.
•During the course of therapy, patients should monitor the skin surrounding the treated
region or the digits of the extremities of the treated limb for any burning, itching,
increased swelling, or pain. If any of these signs present, or any changes in skin
appearance occur (such as blisters, increased redness, discoloration, or other noticeable
skin changes), patients are advised to discontinue use and consult a physician.
•Game Ready Wraps are not sterile; do not place directly against open wounds, sores,
rashes, infections, or stitches. The Wrap may be applied over clothing or dressing.
•Game Ready Wraps are available in multiple configurations but are not intended for
all possible physiologic uses. For example, the Ankle Wrap is not designed for use on
the toes and the Back Wrap is not designed for use in the abdominal region.
•Compression Therapy (vasopneumatic compression) with the Game Ready System
should be used only under the supervision of a licensed healthcare practitioner in
patients:
•Who have an open wound in the affected region (the wound must be dressed prior
to use of Game Ready).
•Who have an acute, unstable (untreated) fracture in the affected region.
•Who are children under 18 years old or patients who have cognitive disabilities or
communication barriers, whether temporary (due to medication) or permanent.
•Who have a cardiac insufficiency or congestive heart failure (with associated
edema in the extremities or lungs).
•Who have a localized skin condition (e.g., dermatitis, vein ligation, gangrene, skin
graft) in the affected region.
•Who have erysipelas or other active infection in the affected region.
•Cryotherapy with the Game Ready System should be used only under the supervision of
a licensed healthcare practitioner in patients:
•Who have Raynaud’s disease or cold hypersensitivity (cold uticaria).
•Who have hypertension or extreme low blood pressure.
•Who have diabetes.
EN-12

•Who have compromised local circulation or neurologic impairment (including
paralysis or localized compromise due to multiple surgical procedures) in the
affected region.
•Who have rheumatoid arthritis in the affected region.
•Who have a known and uncontrolled peptic ulcer since wraps confining and/or
cooling the abdomen can cause increased gastrointestinal motility and gastric acid
secretion.
CAUTIONS
•To avoid the risk of electrical shock, do not remove any panels from the Control Unit.
Opening the case will void the Game Ready warranty. For all servicing and repair, in the
U.S. call Game Ready Customer Service at 1.888.426.3732 (+1.510.868.2100); from
outside of the U.S. please contact your local distributor.
•To avoid the risk of electrical shock, always turn off the System and disconnect the
power line cord from its electrical outlet when not in use or before adding or emptying
ice and water.
•Do not use any AC adapter other than that provided by Game Ready. Use of other
adapters may result in electrical shock and will void the Game Ready warranty.
•To avoid damage to your product, do not operate the System without any water in the
ice box.
•To avoid electrical shock, product malfunction or damage, never operate the System with
damaged power cords or Connector Hoses, or other mechanical damage, or if the unit is
otherwise not fully operational.
•To avoid potential damage to your product, do not pour hot water into the ice box. The
System is not designed to operate, and has not been tested, with hot water.
•Do not use anything but ice and water in the ice box.
•To avoid damage to your product, do not pick up the Control Unit by the lid. Carry the
Control Unit using the handle only.
•To avoid potential damage to your product, do not use other manufacturers’ wraps with
the Game Ready System.
•To avoid damage to your product, do not operate the Control Unit without a Connector
Hose attached.
•To avoid injury, be careful not to trip over the System’s power cords and Connector Hose.
•The GRPro 2.1 Control Unit is a technical medical device. To avoid damage to your
product, handle it with the same care as you would a laptop computer. Do not drop it,
kick it or otherwise abuse it unnecessarily. Such abuse will void all Game Ready warranties.
Do not place the AC Adapter or battery pack inside the ice box for storage or transport.
SPECIFICATIONS
Size: 16.25” length x 7.75” width x 9.25” height (413 x 197 x 235) mm, not including Carry Bag
Weight: 7.3 lb. empty, approximately 18 lb. full of ice and water
Pressure level: cycles from 5mm Hg up to 75mm Hg
AC power: 100-240 V~, 50-60 Hz, 1.6A
DC input: 12V/2.5 A
The maximum operating temperature of the equipment is between 33.8-104ºF (1-40ºC).
The maximum operating altitude of the equipment is 8,000 feet (2,500 meters).
EN-13

UL CLASSIFICATION
EN-14
Protection against electric shock:
The GRPro 2.1 System is considered to be Class I (protective earth) when connected to
the FSP Group, Inc. model FSP 030-RCAM power supply.
Protection against harmful ingress of water:
This product provides ordinary protection against ingress of water.
Pollution degree classification:
This product is classified as Pollution degree 2.
Degree of safety in the presence of flammable anesthetics or oxygen:
Not suitable for use in an oxygen enriched environment or in the presence of flammable
anesthetics.
Game Ready System as to electrical shock, fire and mechanical
hazards only in accordance with EN 60601:2006, CAN/CSA C22.2
No. 60601-1 (2008), and ANSI/AAMI ES60601 (2005 + C1:09 +
A2:10)
Powered by Direct Current
Type BF Applied Parts
Attention: Consult Instructions for Use
Manufacturer
Electromagnetic interference:
This equipment has been tested and found to comply with the limits for medical devices
in IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment 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. If this
equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
•Reorient or relocate the receiving device.
•Increase the separation between the equipment. Connect the equipment into an outlet
on a circuit different from that to which the other device(s) are connected.
•Consult the manufacturer or field service technician for help.

ELECTROMAGNETIC COMPATIBILITY
ELECTROMAGNETIC COMPATIBILITY INFORMATION ACCORDING TO IEC/EN 60601-1-2
Table 1 for Emissions
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC EMISSIONS
The GRPro 2.1 is intended for use in the electromagnetic environment specified below. The customer
or the user of the GRPro 2.1 should assure that it is used in such an environment.
Emissions tEst ComplianCE ElECtromagnEtiC EnvironmEnt – guidanCE
RF emissions CISPR 11 Group 1 The GRPro 2.1 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 B The GRPro 2.1 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/
flicker emissions IEC
61000-3-3
Complies
EN-15

Table 2 for Transient Electromagnetic Immunity
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
The GRPro 2.1 is intended for use in the electromagnetic environment specified below. The customer
or the user of the GRPro 2.1 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
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV 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
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
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 s
<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 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the GRPro
2.1 requires continued operation
during power mains interruptions, it is
recommended that the GRPro 2.1 be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
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 AC mains voltage prior to application of the test level.
EN-16

Table 3 for RF Electromagnetic Immunity
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
The GRPro 2.1 is intended for use in the electromagnetic environment specified below. The customer
or the user of the GRPro 2.1 should assure that it is used in such an environment.
immunitY tEst iEC 60601 tEst lEvEl ComplianCE lEvEl ElECtromagnEtiC EnvironmEnt – guidanCE
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the GRPro 2.1, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d= 1.2 √P80 MHz to 800 MHz
d= 1.2 √P80 MHz to 800 MHz
d= 2.3 √P800 MHz to 2.5 GHz
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 meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,ashould be less than the compliance
level in each frequency range.b
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 GRPro 2.1 is used exceeds the applicable RF compliance level
above, the GRPro 2.1 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the GRPro 2.1.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
EN-17