Zimmer CryoMini User manual

Operating Instructions
CryoMini
JP (GB)

Symbol Explanation
When used in this manual, this symbol indicates danger to patient, user or third person.
!
When used in this manual, this symbol indicates a warning for possible harm to the unit.
Device Type B Electrical Shock Protection Level
CryoMini This User Manual is to be considered as part of the CryoMini device itself and is therefore always to
be kept in close vicinity of the device. Careful observation to instructions found within the User
Manual is the supposition for correct usage and handling of the device as well as for patient and
operator safety.
!Note: Should the CryoMini need to be turned onto its side for maintenance or transportation, the
device needs to stand upright for at least 30 minutes before it is switched on to avoid
compressor damage, and the defrosted water container located at the side of the device
needs to be checked to insure correct placement.

1
Table of Contents
Page
Schematic Overview 2
1 CryoMini in Brief 5
2 Assembly Instructions 7
3 Operating Instructions 8
4 Adjustments, Settings and Menus 9
4.1 Detailed Menu Options 10
4.2 Treatment Settings 14
5 Maintenance 15
6 Models, Parameters and Adjustments for Preset Values 16
7 Indications / Contra-indications 17
8 Warnings 18
9 Technical Data 19
10 Cleaning and Disinfection 20
11 Treatment and Application Suggestions 21
12 Parts and Accessories 22
13 Safety 23
14 Error Messages and Signals 24
15 Disposal 25
16 EMC Manufacturer’s Declaration 26

2
Schematic Overview
Front View
Figure 1
Legend:
1 Castor
2 Castor guards
3 Control panel
4 Standoff
5 Treatment tube connector
1
2
4
5
3

3
Back and Left Side View
Figure 2
Figure 3
Legend:
6 Defrosted Water Container
7 Air Filter
8 Mains Switch
9 Mains Inlet
19 Label
7
8 9
19
6

4
Control Panel: Controls and Display
530:00
OK Start/ Stop
-10°C
Cooling recommended
Figure 4
Function Keys:
10 Increase Treatment Time
11 Decrease Treatment Time
12 Increase Fan Speed Level
13 Decrease Fan Speed Level
14 OK
15 Start/Stop
16 Fan Symbol
16.1 Fan Speed
17 Time Symbol
17.1 Treatment Time
18 Evaporator Temperature
18.1 Warning Text
13 12
14
11 10
15
16
16.1
17
17.1 18 18.1

5
CryoMin
i
in Brief
1.
 What is the CryoMini?
CryoMini is a compact unit providing cold air to be used for skin cooling in
conjunction with dermatological laser treatments to reduce pain and thermal
damage to skin tissue.
 What does the CryoMini do?
CryoMini blows cold air at an adjustable rate onto the patient’s body section
requiring therapy.
 What is the CryoMini's main advantage?
The CryoMini features a user-friendly keyboard, which makes it very simple to
operate.
A highly effective cryotherapy is achieved, providing a level of performance in
continuous operation found normally only in much larger devices.
 What other advantages does the CryoMini have?
CryoMini is economic and cost-effective, as it filters and cools room temperature
air using a closed cooling circuit without the need for additional consumables.
The clear LCD display and ergonomically designed keypad represent the latest
technological developments.
 How does CryoMini achieve the necessary cooling concentration?
Air flow can be varied in 9 steps according to the size and accessibility of the area
to be treated (level 1 = ~200 litres/min, level 9 = ~1300 litres/min).
Note:
CryoMini is intended for operation by or on order of authorized medical professionals
only.

6
CryoMin
i
in Brief
1.
 Pre-cooling Phase and The Minimal Load
The Pre-cooling Phase begins once the CryoMini has been switched on. During
this phase, the compressor and the condenser fan work together to reduce the
temperature and to store a minimal cold reserve quantity, referred to as the
“Minimal Load”. During the Pre-cooling Phase, a bar graph is displayed on the
screen indicating the pre-cooling status (Figure 8). No other functions are
possible until the Pre-cooling Phase is complete, except entering the Menu. Once
the Minimal Load has been obtained, the screen changes to the Start Display.
Therapy and other functions are now possible. The compressor and condenser
fan continue to run, however, until the Total Load has been reached.
 The Total Load
The Total Load refers to the steady maintenance of the maximum cold
temperature in the cold reserve. During treatment, the therapy fan will be running
to blow the cold air through the treatment tube. Additionally, the compressor and
the condenser fan will run automatically in order to compensate for the loss of
cold capacity during treatment, and will continue to run until the cold reserve is
complete. Once complete, the compressor and condenser fan stop and CryoMini
shifts into a Stand-by-Mode. The Total Load refers to the steady maintenance of
the maximum cold temperature in the cold reserve.
 The Stand-by Mode
If the device is not used for approximately 30 minutes* (in Stand-by Mode), the
cold reserve decreases. The compressor and condenser fan will then
automatically start running in order to re-cool and complete the cold reserve.
During the Stand-by Mode, treatment is possible.
*The frequency required to maintain adequate cold reserve may change
according to the climatic conditions and temperatures.
 Suggestion for Optimal Use
It is suggested to wait approx. 5 minutes after the Pre-cooling Phase is complete
(indicated by the screen change from pre-cooling bar graph to Start Display). This
insures that a Total Load with a complete cold reserve has been obtained. When
the first treatment is initiated immediately after the Pre-cooling Phase, the cold
reserve is depleted immediately and subsequent treatments are delayed.
In order to avoid waiting periods due to the Pre-cooling Phase, it is recommended
to switch off the CryoMini only at the End of the day.

7
Assembly Instructions
2.
Step 1:
Treatment tube (6)
Attach the treatment tube to the air outlet of the CryoMini (5, Figure 1).
Figure 5
Step 2:
Mounting of the glass
plate
Place a silicon washer on each 4 pre-assembled standoffs.
Place the glass plate onto the standoffs.
Affix the glass plate using the U-shaped pin to screw the four, grey, flat screws
through the glass plate and into the standoffs.
Figure 6
Step 3:
Castor guards (2)
Firmly press the castor guards over the metal castor mountings (if not pre-
assembled).
Do not lift the unit by the glass plate!
Flat Grey Screw
Glass Plate
Standof
f

8
Operating Instructions
3.
Switch on Unit Mains Switch (8, Figure 2), the display illuminates.
Operating Status
and Therapy Once the device is switched on, a Pre-cooling Phase is initiated and the current status is displayed on a bar graph (i.e. self test, pre-cooling etc.). When the device is ready
for operation, the screen changes from the Pre-cooling Mode to the Therapy Mode
display.
The therapy fan speed and treatment time can be adjusted directly by using the
Function Keys. Pressing the Start/Stop button starts the therapy.
705:30
OK Start/ Stop
- 10°C
Figure7
Treatment End The treatment ends automatically after program completion, or if the user presses the
Start/Stop Key during the treatment. The end of the treatment is indicated by an
acoustic signal.

9
Adjustments, Settings and Menus
4.
Switch on unit Switch on at mains switch (8, Figure 2).
Self-test After device has been switched on, CryoMini performs a routine self-test.
Adjustments to
System Menu
During the self-test and the Pre-cooling Phase, the System menu may be accessed
and settings changed.
Menu
OK
Pre-cooling
0% 100%
Figure 8
To enter the Menu Selection mode, press the Menu button on the
display (10,Figure 4).
OK Default Settings
Automatic Service Program S01
Automatic Service Program S02
Info
Start/ Stop
Device Configuration
Select
Figure9
Use the Function Keys (12, 13, Figure 4) marked with arrows on the display to
navigate through the 8 menu items available.
The individual menu items are described in detail below:
Info
Automatic Service Program S01
Automatic Service Program S02
Device Configuration
Default Settings
Service
Back to Treatment
Defrosting
Use the Function Key (10, Figure 4) to select the required submenu.

10
Adjustments, Settings and Menus
4.1 Detailed Menu Options
4.
Info Displays system technical data.
No adjustments can be made in this option.
Automatic Service
Program S01 Only for use upon request of a technician.
Automatic Service
Program S02 Only for use upon request of a technician.
Device Configuration Use this submenu to change the language used in the displays or to make technical
adjustments.
Use the arrow and Select Key to select the desired option.
Evaporator temperature displayed:
Select CHANGE (13, Figure 4) to change the state. If ON is selected, the Evaporator
temperature will be displayed in therapy Screen (18, Figure 4). The displayed
temperature is NOT the AIR temperature.
OK Start/ Stop
Evaporator temperature displayed
STOREBACK
CHANGE
State: ON
Figure 10
Setting of warning threshold:
Use this Submenu to set the Temperature warning threshold, to display the warning
text in the Therapy screen and to activate the audio warning when the Evaporator
temperature reaches the setting warning threshold.
 Audio warning: Select CHANGE (13, Figure 4) to change the state. If ON is
selected, a beep sound will be generated for 2 Min. in 1 sec. Rhythm. Press Store
Key (10, Figure4) to apply and save the new setting.
OK Start/ Stop
Audio warning
STOREBACK
CHANGE
State: ON
Figure 11

11
Adjustments, Settings and Menus
4.1 Detailed Menu Options
4.
 Setting of temperature warning threshold:
Use the setting to adjust the temperature warning threshold between –20 °C to
+20°C. The factory-preset value is 4°C. Press Store Key (10, Figure 4) to apply
and save the new setting.
OK Start/ Stop
Setting of temperature warning threshold
StoreBack
Temperature [-20..+20] °C: 4
Figure 12
 Warning text in display:
Select CHANGE (13, Figure 4) to change the state. If ON is selected, the warning
text will be displayed in the Therapy screen(18.1, Figure 4). Press Store Key (10,
Figure 4) to apply and save the new setting.
Figure 13
Language:
Various languages are available: German, English, and French.
OK Start/ Stop
Evaporator temperature displayed
Setting of warning threshold
Display-Backlight
SelectBack
Language
Display-Contrast
Figure 14
OK Start/ Stop
Warning text in display
STOREBACK
CHANGE
State: ON

12
Adjustments, Settings and Menus
4.1 Detailed Menu Options
4.
Display-Backlight:
The time duration before CryoMini switches into Stand-by mode and the resulting
screen saver modus (indicated by a dimming in the display) may be adjusted under
this menu. Use the Arrow Keys (12, 13, Figure 4) to select a period between 0 and
300 seconds. The factory-preset value is 180 seconds. Press Store Key (10, Figure 4)
to apply and save the new setting.
OK Start/ Stop
Delay time prior to screen saver
StoreBack
(Alternative: 0=> no screen saver)
[1..300] sec: 180
Figure 15
The screen saver promotes display durability.
Display-Contrast:
Use the setting to adjust the brightness of the display between 10 (minimum contrast)
to 30 (maximum contrast).
OK Start/ Stop
Setting of Display-Contrast
StoreBack
Contrast Value (10-30) : 18
Figure 16
Default Settings Select either YES or NO (10, 11, Figure 4). No other option is available. If YES is
selected, all settings are returned to their original default values.
OK Start/ Stop
Reset default configuration?
NoYes
Figure 17

13
Adjustments, Settings and Menus
4.1 Detailed Menu Options
4.
Service This option is password-protected and accessible only by authorized personnel trained
by Zimmer MedizinSysteme. To leave this menu option, press OK (14, Figure 4).
OK Start/ Stop
Please enter passwort:
1 2 43
[............]
Figure 18
Back to Treatment This option exits the menu and returns to the treatment display.
Defrosting Defrosting begins immediately once the Defrost program is selected. It can be
cancelled by pressing the Back Key (11, Figure 4). The unit draws in ambient air,
which passes through the cold circuit (without being cooled) and passes it out through
the treatment tube. The defrosted water flows into the container at the side of the
device.
OK Start/ Stop
Defrost mode activated
0% 100%
Back
Figure 19

14
Adjustments, Settings and Menus
4.2 Treatment Settings
4.
Treatment screen
705:30
OK Start/ Stop
- 10°C
Figure 20
After Pre-cooling Phase, the CryoMini is ready for treatment.
Pressing the Start/Stop button starts treatment.
Treatment End When the Treatment Time has elapsed, the air supply is cut off and an acoustic signal
is emitted. The program can also be ended manually by pressing the
Start/Stop key (15, Figure 4).
Treatment Time Setting Time ranging from 00:00 and 99:59 minutes may be set.
Pressing the Up or Down Key once increases or decreases the Treatment Time in 1
minute intervals.
By holding the Up or Down key pressed, the Treatment Time increases or decreases
in 10 minute intervals.
Should an extended Treatment Time inadvertently have been set, pressing the
Start/Stop key (15, Figure 4) twice will revert the system to the factory preset time for
the program. This procedure can also speed up decreasing the Treatment Time.

15
Maintenance
5.
Service Elements: Back Panel
(8) Mains switch: The mains power switch is located at the rear of the unit. CryoMini performs an
automatic self-test after mains switch is turned on (see Figure 2).
(7) Air filter: The unit features an air filter (7, Figure 2) to remove coarse dust particles from the air
used for cooling and treatment. In normal use, it is sufficient to clean the filter, which is
located at the rear of the unit, with a vacuum cleaner. This should be carried out at
least every 150 hours of use, when the software issues a corresponding signal. If the
unit is operated in rooms with carpets or in other environments with a high level of
dust, it is recommended that the filter be cleaned more frequently.
Note: After cleaning the filter, the signal issued by the software is reset by pressing
the appropriate button mentioned in the display.
Power safety shut
down:
CryoMini is fitted with a 2-pole overload circuit breaker to protect the unit from power
supply irregularities. The circuit breaker is integrated into the Mains switch (8). If the
circuit breaker is triggered, the unit must be switched off before it can be reset.
Service Elements: Side Panel
(6) Defrosted water
container:
If CryoMini is switched off after use, or if the defrosting program is activated, the
cooling system warms up and creates condensation. The unit contains a Defrosted
Water Container , which holds about 1 liter and may be removed when full to empty it.
The container should be cleaned after emptying and then placed back in the device.
CryoMini should not be operated with the container removed.
!
!
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16
Models, Parameters and Adjustments
for Preset Values
6.
Models: Different models are available to suit different power supply voltages.
Preset parameters: Each unit leaves the manufacturer with a set of standard preset parameters. These
may be restored at any time by selecting the Main Settings function (see Adjustments,
Settings and Menus, Chapter 4).
Adjustments to preset
parameters:
CryoMini allows the Airflow and Treatment time to be adjusted and saved to meet the
specific individual requirements. (see Adjustments, Settings and Menus, Chapter 4).
1. Display-Contrast: adjustable from 10 to 30 ;
Default Value:18.
2. Language: Various Languages;
Default Language: English .
3. Display-Backlight: adjustable from 1 to 300 sec;
Default Value:180.

17
Indications / Contra-indications
7.
The CryoMini is intended to minimize pain and thermal injury during laser and
dermatological treatments and for temporary topical anesthetic relief for injections.
Indications - Skin cooling during laser treatment to minimize pain and thermal skin tissue
damage, e.g.
- Hypertrichosis
- Naevus flammeus
- Haemangioma
- Removal of tattoos
- Actinic keratosis
- Hair depilation
Advantages The analgesia caused by the cold air makes treatment significantly more pleasant for
the patient.
Some of the common side-effects of laser treatment are also reduced:
- Minimal erythema
- Reduced swelling and scab formation
- Pain and thermal skin tissue damage
Contra-indications Hypersensitivity to cold (allergy)
Localised frostbite
Raynaud’s disease
Arterial perfusion problems (areas of impaired circulation)
Altered skin sensitivity (areas of impaired sensation)
Open wounds
Ablative laser treatment
Cryoglobulinaemia
Cold agglutinin disease
Treatment
Information
Patient must be informed prior to the therapy concerning CryoMini skin cooling effects.
Should the patient feel increased discomfort or sensitivity to excessive heat or cold,
he should inform the CryoMini operator at once.
The airflow level and the distance between the treatment tube’s adapter and the
treatment area should be selected to maximize patient’s comfort. The CryoMini
operator should continue to inquire into the patient’s comfort during the treatment., and
the treatment parameters (airflow and therapy distance) should be modified
accordingly.
For temporary topical anesthetic relief for injections, the treated area should be cooled
to a comfortable level for the patient. Prior to the injection, the treated area must be
disinfected to avoid contamination.

18
Warnings
8.
 CryoMini is intended for operation by or on order of authorized medical
professionals only.
 Should the CryoMini need to be turned onto its side for maintenance or
transportation, the device needs to stand upright for at least 30 minutes before it is
switched on to avoid compressor damage, and the defrosted water container
located at the side of the device needs to be checked to insure correct placement
 Do not place the unit in direct contact with sources of heat (radiators, mud
preparations, saunas etc). Ensure a distance of at least 50 cm between the unit
and the wall to allow air inflow.
 Unfavorable ambient conditions (e.g. ambient temperature above 86°F (30°C)
and high humidity) may lead to a reduction in performance (reduced cooling
capacity).
 Magnetic and electric fields may affect the operation of the unit. Do not use
CryoMini close to equipment that generates strong electromagnetic fields (e.g. X-
ray or diathermy equipment or nuclear magnetic resonance tomography devices)
 Dispose of packaging material properly. Keep such material out of reach of
children.
 CryoMini is not designed for use in explosive or inflammable environments.
 To avoid contaminating open wounds, the CryoMini can only be used before
injections (not during or afterwards).
 To avoid freezer burns and over-cooling, the air stream should be directed evenly
over the entire area to be treated. Static cooling, or overly intensive cooling,
should be avoided.
 Do not increase laser output power or energy when using CryoMini for skin
cooling. Always operate the laser in accordance with its user manual.
 Skin cooling may reduce effectiveness of some laser treatments when laser has
the identical power output.
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