Zimmer CryoMini User manual

Instructions for Use
CryoMini
GB/EU

Illustrations
Front of Device
Fig. 1
Equipment and
Controls
1
Castor
2
Castor guards
3
Control panel
4
Tray
5
Treatment tube connection
Fig. 2
6
Treatment tube
7
Treatment tube connector socket
1
2
4
5
3
6
7

Illustrations
Rear / Left side of Device
Fig. 3
Fig. 4
Equipment
and
Controls
8
Air filter
9
Identification plate
10
Mains switch
11
Power inlet
12
Condensation water container
8
10
11
9
12

Illustrations
Screens / Displays
Fig. 4
530:00
OK Start/ Stop
-10°C
Cooling recommended
Display
controls
13
Increasing treatment time
14
Reducing treatment time
15
Increasing fan speed
16
Reducing fan speed
17
OK button
18
Start/Stop key
19
Fan speed icon
20
Fan speed display
21
Symbolic display of treatment time
22
Treatment time
23
Temperature of vaporiser
24
Note / Warning
16
15
17
14
13
18
19
20
21
22
23
24

Explanation of Symbols
In the instructions for use this symbol indicates
“Danger”
.
Caution!
In the instructions for use this symbol indicates „Caution“ with regard to possible
damage of the device..
Applied part type B
Do not push sideways.
Maximum permissible load on the glass plate 35kg.
Follow Instructions for Use.
Operation instruction
Serial number
Article number
Manufacturer
Date of manufacture
Max 35 kg /
77.16 lb

Content
Illustrations
Front of Device
Rear / Left side of Device
Screens / Displays
Explanation of Symbols
Page
1
Indications / Contraindications
1.1 Indications / Contraindications in the Physical Therapy
1.2 Indications / Contraindications in the Aesthetics
1
2
2
Side Effects 3
3 Application information 4
4Warnings 6
5CryoMini - in brief 7
6Device Set Up 8
7
Operation instructions
7.1 Device description
7.2 Performing the treatment
10
11
8Settings 12
9 Technical Information 17
10 Cleaning / Disinfection 18
11 CE-mark 19
12 Scope of Delivery and Accessories 20

Content
13 Device Combination 21
14
Safety and Maintenance
14.1 Safety
14.2 Maintenance
22
23
15 Functional Test 24
16 Safety Check / Metrological Control 25
17 Error Messages / Troubleshooting / Disposal 26
18 Manufacturer´s EMC declaration 28
Valid for the CryoMini devices.
This instructions for use is an integral part of the device. It must be stored with
the device and kept accessible at all times for anyone authorized to operate this
device.
The instructions for use is valid as of November 2014.

Indications / Contraindications
1.1 Indications / Contraindications
in the Physical Therapy
1
Page 1
Indications
CryoMini is intended for the following areas of application:
•Reduction of pain and stiffness and as a supplemental treatment for acute and
chronic painful diseases of the musculoskeletal system
-Arthritis
-Bursitis
-Tendinitis
-Tenosynovitis
-Myositis
-Fibromyalgia
-Muscle tension
-Cervical syndrome
-Post-whiplash disorders
-Lumbar syndrome
-Muscle or joint injuries
•Pain reduction, improvement of mobility and reduction of joint stiffness for
rheumatic diseases
-Rheumatoid arthritis (progressive chronic arthritis)
-Post-synovectomy conditions
•Reduction of spasms for neurological disorders
-Multiple sclerosis
-Post-apoplectic hemiplegia
Other possible applications:
•support for movement therapy using preceding cooling
•in combination with compresses for acute injuries
•for preventing edemas and hematomas
•in the field of sports medicine for preventative early treatment prior to pain setting
in, immediately after severe stress, e.g. competitions
•for treating muscular trigger points in combination with stretching
Other indications should be discussed with the treating physician or taken from
relevant technical literature.
Absolute
contraindications
•
Cryoglobulin aemias
•Cold agglutinin disease and cryohemolysis
•Cold urticaria
•Areas with circulatory disorders
•Raynaud's syndrome
•Areas with sensitivity disorders
•Trophic disorders
•Hypersensitivity to cold
Relative
contraindications
•
In the treatment of children, the untreated parts of the body must be covered and
kept warm.
•For treatments of the face, the eyes must be covered.
•Do not treat face and torso, if a severe arterial hypertension and severe cardiac
insufficiency is present.
•The patient should not be cold during treatment.

Indications / Contraindications
1.2 Indications / Contraindications
in the Aesthetics
1
Page 2
Indications
CryoMini is intended for the following areas of application:
Pain and inflammation reduction by cooling using cold air during and after the
application of dermatological and cosmetic treatments
•laser therapy
•injections
•photodynamic therapy
Advantages
The treatment is significantly more pleasant for the patient due to the analgesic
effect of the cold air.
Reduction of the side effects frequently connected to laser applications:
•minor erythema
•less swelling and scabbing
•reduction of pain and thermal skin damage
Absolute
contraindications
•
cryoglobulin anemias
•cold agglutinin disease and cryohemolysis
•cold urticaria
•areas with circulatory disorders
•Raynaud's syndrome
•areas with sensitivity disorders
•trophic disorders
•hypersensitivity to cold
Relative
contraindications
•
When treating children, body parts not being treated must be covered and kept
warm.
•The face and eyes must be covered during treatment.
•
Do not treat the face and torso if there is severe arterial hypertension and severe
cardiac insufficiency.
•The patient should not be cold during treatment.
Notice:
When using the CryoMini with ablative lasers, make sure that the resulting wound is
properly antiseptic treated after treatment.

Side Effects
2
Page 3
Side effects Cold-related skin damage, such as skin irritations up to slight frostbite and chilblains
may occur, especially in sensitive patients.

Operation Instructions
3
Page 4
Before using the device on a patient, the user should become acquainted with the
operating instructions and individual treatment methods as well as the indications /
contraindications, warnings and application information. Additional sources of
information about types of therapy should be consulted.
These instructions for use must be kept with the device so that it is accessible at all
times to the persons who operate the device.
Caution !
The device must be allowed to stand upright for at least 30 minutes before it is
turned on following transport in a horizontal position, or after it was positioned
horizontally for repair. The cooling unit will be damaged, otherwise.
Caution !
Before use, ensure that the device is powered via a properly earthed plug with a
grounded outlet (electrical installation according to DIN VDE 0100 Part 710). The
device must only be operated with the supplied power cord. The power cord must be
protected against mechanical stress.
Caution !
Operation of this equipment in the vicinity of strong electromagnetic fields (e.g.
tomographs, x-ray or diathermy equipment) may interfere with the operation of the
device. Please keep a safe distance of several meters.
CryoMini is not suitable for operation in explosive, flammable or combustive
environments.
Do not position the device in the immediate vicinity of heat sources (heating, fango
preparation systems, sauna, etc.) and observe a distance of at least 50 cm to the
wall (treatment and cooling air supply).
When in operation, the device must be positioned in such way that direct access to
the power supply of the device is possible, so that it can be disconnected from the
mains at any time.
To avoid the risk of electric shock; the device must be disconnected from the mains
by unplugging the power cord before performing any maintenance or cleaning
activities.
Inspect the device before use. In case of damage, the device must not be used.
Caution !
Only accessories from Zimmer Medizin Systeme GmbH are to be used.

Operation Instructions
3
Page 5
The device may cause malfunctions, or may interfere with the operation of
equipment in its vicinity through electromagnetic effects. It may be necessary to take
appropriate remedial action, such as a new orientation, a new arrangement of the
device, or an electromagnetic shielding.
Prior to treatment, patients should be informed about the objectives and effects of
the cold air therapy with CryoMini.
Advise patients that abnormal sensations occurring during the treatment, such as
extreme cold sensation, must be reported immediately to the operator.
During therapy, the treatment provider should ensure the well-being of patients
through appropriate questions.
If necessary, the treatment parameters (air power level and distance to the treatment
area) should be adjusted.
Joints and muscles require prolonged treatment; otherwise, only the skin surface
and upper skin layers will be cooled. In the case of joint inflammation, the short-term
cooling results in a reactive hyperaemia.
Please note that after prolonged treatment, the temperature of the airflow may
increase.
In unfavourable conditions (room temperature over 30° C and high humidity), the
cooling capacity may be limited.

Warnings
4
Page 6
Users of the CryoMini system must be instructed in the proper use of the system and
have the appropriate skills.
The device is intended to be used exclusively by medical professionals.
The patient should be carefully monitored throughout the treatment.
Treatment instructions regarding the place of treatment, duration and intensity of
treatment require medical knowledge and may only be given by licensed physicians,
therapists and ancillary medical staff. It is imperative that these instructions are
followed.
The use in wet areas is not permitted and may in case of non-compliance lead to
considerable damage to the device and endanger both the patient and the user.
Dispose of the packaging material correctly. Make sure that it is not accessible to
children.
The cold air flow may not be applied to open wounds.
For application of cold in the face, the eyes must be protected.
The air flow should be evenly applied over the treated area. Static or too intensive
cooling must be avoided, as it can lead to frostbite and hypothermia.
The use of this product with settings or applications, other than those specified in the
operating manual, may lead to a hazard through uncontrolled exposure to cold.
In children, there is a risk of hypothermia. The untreated body parts should be covered
and kept warm. This is also recommended for adults in the case of a long-term
cooling.
Frostbite occurs at skin temperature of 0° C and below. This may be possible when
the distance of the nozzle to the skin is less than 10 cm. If this distance cannot be met
for therapeutic reasons, a dynamic guiding of the nozzle over the treatment area is
recommended.

CryoMini - in brief
5
Page 7
What is CryoMini?
A compact cold air device for the treatment of musculoskeletal diseases.
What does CryoMini
perform?
Cold air is blown with an adjustable flow rate to the treated body area.
What are the
advantages of
CryoMini?
The clearly structured LCD display and the ergonomic keyboard feature stated-the-
art technology.
The operation of the device leads to low energy consumption.
Intended Use
The cold air device CryoMini is used for skin cooling
- in the treatment of injuries or musculoskeletal diseases
- for local pain relief.
Note:
The application of the device is reserved for medical professionals
(such as physicians, therapists and health paraprofessionals).

Device Set Up
6
Page 8
Therapy hose
connect
The therapy hose is connected and locket into the connecting piece of CryoMini.
Install glass plate
Put a silicone washer on each of the 4 spacing bolts mounted in the hood.
Then place the glass plate on the spacing bolts.
Attach the glass plate by screwing clamp bearings in each of the 4 spacing bolts. For
this, use the supplied U-tool.
Do not lift CryoMini on the glass plate!
Clamp bearings
Glass plate
Spacing bolt

Device Set Up
6
Page 9
Assemble castor
guards
The castor guards are plugged onto the castor holders.
Connect power cord
Connect the power cord to the designated port (11) of the device and connect it to the
mains.
Note:
The device may only be connected to sockets with protective earth.
Caution !
After transport or assembly work in a horizontal position, CryoMini must stand upright
for at least 30 minutes before switching on.
The compressor may otherwise be damaged.
Turn the device on
The device is switched on using the toggle switch (10).
Turn the device off
The device is switched off using the toggle switch (10).
To disconnect the device completely (all-pole) from the mains, unplug the power cord.
Caution !
All cables must be protected from pinching or other mechanical damage.

Operation Instructions
7.1 Device Description
7
Page 10
Pre-cooling
Once CryoMini is turned on, the device starts to pre-cool to the minimum reachable
temperature. During this phase, the compressor and the capacitor fan work together.
At the same time, the device performs a self-test. During the self-test or pre-cooling,
no entries can be made on the display. Merely the "Menu" button (8) can be
manipulated to reach the configuration menu. When the pre-cooling is sufficient, the
display automatically returns to start screen. CryoMini is now ready for use.
Operation
During therapy, the therapy fan blows cold air through the treatment hose. At the same
time, the compressor / capacitor starts automatically during the treatment to ensure a
constant cooling.
Stand-by mode
If no therapy is performed, CryoMini is in stand-by mode. In order to ensure that
sufficient cool air can be provided at any time, the compressor starts automatically as
soon as a certain temperature is exceeded. An immediate start of treatment is
possible from the stand-by mode.
Recommendation for
optimal treatment
When treatment starts, a waiting time of about 10 min. is recommended after the
precooling. This ensures that the device has reached its maximum cooling capacity.
It is also recommended to turn off CryoMini only for longer treatment breaks or at the
end of the day.

Operation Instructions
7.2 Performing the Treatment
7
Page 11
Turn the device on
Switch on the device using the toggle switch (10), the display will light up.
Operational readiness
Start of treatment
Once the device is turned on, the pre-cooling / self-test begins. CryoMini is ready
when the start-up screen shows. The treatment can be started by pressing the Start /
Stop button.
Fan level and treatment time can be adjusted optionally.
705:30
OK Start/ Stop
- 10°C
End of treatment
The end of treatment with automatic fan shutdown is signalled
acoustically. This also applies to a premature termination of treatment through
the "Start / Stop" button.
Note:
The patient should be carefully monitored throughout the treatment.

Settings
8
Page 12
Self-Test
After switching on, CryoMini performs a self-test.
During the test, the current status of the pre-cooling can be read.
Menu
During the self-test / initialisation, it is possible to switch to the menu
to configure basic settings.
To enter the menu, press "Menu" on the display during the self-test.
OK Default Settings
Automatic Service Program S01
Automatic Service Program S02
Info
Start/ Stop
Device Configuration
Select
Technical information can be queried and changed in the menu. To access the
various menu options, use the arrow keys.
The following may be selected:
•Info
•Automatic Service Programme S01
•Automatic Service Programme S02
•Device Configuration
•Default settings
•Service
•Back to treatment
•Defrosting
Selection of menu
items
Info
Automatic
maintenance
programme S01
Automatic
maintenance
programme S02
The selection of a menu item is done with the "Select" button.
Display of technical information about various device components.
No setting is possible.
Only for trained technicians.
Only for trained technicians.

Settings
8
Page 13
Device Configuration
Basic settings (such as language) can be set or changed in the device configuration
using arrow keys.
Vaporiser temperature display:
Select "CHANGE" to change the current setting.
If "ON" is selected, the vaporiser temperature will be shown on the display. The
temperature displayed is NOT the air temperature.
OK Start/ Stop
Evaporator temperature displayed
STOREBACK
CHANGE
State: ON
Warning threshold setting:
Use this submenu to display the warning on the display and to enable/disable the
acoustic alarm.
Warning:
Select "CHANGE" to change the current setting.
If "ON” is selected, the alarm will sound for 2 minutes in intervals of one second.
Press "SAVE" to save the changed settings.
OK Start/ Stop
Audio warning
STOREBACK
CHANGE
State: ON
Setting warning threshold temperature:
With this menu, you can set the temperature warning threshold between
-20° C and +20° C. The factory setting is 4° C. Press "SAVE" to save the changed
settings.
OK Start/ Stop
Setting of temperature warning threshold
StoreBack
Temperature [-20..+20] °C: 4