CryoMini Operating Instructions Ver 1.0 June 2010

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.

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

1

Schematic Overview Front View

4 3

5

2 1

Figure 1

Legend: 1 2 3 4 5

Castor Castor guards Control panel Standoff Treatment tube connector

2

Back and Left Side View

9

8 19

7

Figure 2

6

Figure 3

Legend: 6 7 8 9 19

Defrosted Water Container Air Filter Mains Switch Mains Inlet Label

3

Control Panel: Controls and Display

18.1

16.1

18

17.1

Cooling recommended

5

14 OK

-10°C

30:00

Figure 4

13

16

12

11

Function Keys: 10 11 12 13 14 15 16 16.1 17 17.1 18 18.1

Increase Treatment Time Decrease Treatment Time Increase Fan Speed Level Decrease Fan Speed Level OK Start/Stop Fan Symbol Fan Speed Time Symbol Treatment Time Evaporator Temperature Warning Text

4

17

10

15 Start/ Stop

CryoMini 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.

5

CryoMini 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.

6

Assembly Instructions

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.

Flat Grey Screw Glass Plate

Standoff

Figure 6

Step 3: Castor guards (2)

Firmly press the castor guards over the metal castor mountings (if not preassembled).

Do not lift the unit by the glass plate! 7

2.

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.

7

- 10°C

OK

05:30

Start/ Stop

Figure 7

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.

8

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. Pre-cooling

0%

100%

OK Menu

Figure 8

To enter the Menu Selection mode, press the Menu button on the display (10,Figure 4).

OK

Info Automatic Service Program S01 Automatic Service Program S02 Device Configuration Default Settings

Start/ Stop Select

Figure 9

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. 9

Adjustments, Settings and Menus

4.

4.1 Detailed Menu Options 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. Evaporator temperature displayed State: ON

OK

Start/ Stop CHANGE

BACK

STORE

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. Audio warning State: ON

OK

Start/ Stop CHANGE

BACK

Figure 11

10

STORE

Adjustments, Settings and Menus

4.

4.1 Detailed Menu Options 

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. Setting of temperature warning threshold Temperature [-20..+20] °C:

4

OK

Start/ Stop Back

Store

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. Warning text in display State: ON

OK

Start/ Stop CHANGE

BACK

STORE

Figure 13

Language: Various languages are available: German, English, and French.

Evaporator temperature displayed Setting of warning threshold Language

OK

Display-Backlight Display-Contrast

Start/ Stop Back

Figure 14

11

Select

Adjustments, Settings and Menus

4.

4.1 Detailed Menu Options

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. Delay time prior to screen saver (Alternative: 0=> no screen saver) [1..300] sec:

180

OK

Start/ Stop Back

Store

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). Setting of Display-Contrast Contrast Value (10-30) :

18

OK

Start/ Stop Back

Store

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. Reset default configuration?

OK

Start/ Stop Yes

Figure 17

12

No

Adjustments, Settings and Menus

4.

4.1 Detailed Menu Options

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). Please enter passwort: [...]

OK

Start/ Stop 1

2

3

4

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. Defrost mode activated

0%

100% Start/ Stop

OK Back

Figure 19

13

Adjustments, Settings and Menus

4.

4.2 Treatment Settings

Treatment screen

7

- 10°C

OK

05:30

Start/ Stop

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.

14

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.

15

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.

16

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

-

Advantages

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

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. 17

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. Xray 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.

18