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.
 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

Figure 1

Legend:

1 Castor
2 Castor guards
3 Control panel
4 Standoff
5 Treatment tube connector

2
 Back and Left Side View

8 9

19

Figure 2

Figure 3
Legend:
6 Defrosted Water Container
7 Air Filter
8 Mains Switch
9 Mains Inlet
19 Label

3
 Control Panel: Controls and Display

18.1 16.1 18 17.1

Cooling recommended
14

OK
5 -10°C 30:00 Start/ Stop
15

Figure 4

13 16 12 11 17 10

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

4
 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 2.

Step 1: Attach the treatment tube to the air outlet of the CryoMini (5, Figure 1).
Treatment tube (6)

Figure 5

Step 2: Place a silicon washer on each 4 pre-assembled standoffs.

Mounting of the glass
plate 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: Firmly press the castor guards over the metal castor mountings (if not pre-
Castor guards (2) assembled).

Do not lift the unit by the glass plate!

7
 Operating Instructions 3.

Switch on Unit Mains Switch (8, Figure 2), the display illuminates.

Operating Status Once the device is switched on, a Pre-cooling Phase is initiated and the current status
and Therapy 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 05:30
OK 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 During the self-test and the Pre-cooling Phase, the System menu may be accessed
System Menu 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).

Info
Automatic Service Program S01
Automatic Service Program S02
Device Configuration
Default Settings
OK 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 Only for use upon request of a technician.

Program S01

Automatic Service Only for use upon request of a technician.

Program S02

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 STORE

Figure 11

10
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
Display-Backlight
Display-Contrast
OK Start/ Stop
Back Select

Figure 14

11
 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 No

Figure 17

12
 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%

OK Start/ Stop
Back

Figure 19

13
 Adjustments, Settings and Menus 4.

4.2 Treatment Settings

Treatment screen

7 - 10°C 05:30
OK 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 CryoMini is fitted with a 2-pole overload circuit breaker to protect the unit from power
down: 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 If CryoMini is switched off after use, or if the defrosting program is activated, the
container: 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 6.
for Preset Values

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 CryoMini allows the Airflow and Treatment time to be adjusted and saved to meet the
parameters: 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 - 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 Patient must be informed prior to the therapy concerning CryoMini skin cooling effects.
Information 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. 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.

18
 Technical Data 9.

Supply voltages: 100V V / 50-60 Hz

Connect the unit to the adequate mains voltage and frequency only.

Current consumption: standby: ~1A

maximum: 6A
Supply protection in unit: 16A circuit breaker in Mains switch
Protection level: I
Application class: Type B, in accordance with IEC 601-1
MPG class: Iia
Storage / Transport: Temperature: -10°C to +50°C max
Pressure: 700 hPa to 1060 hPa
Steady humidity level from 10 % to 90 %
Note: Storage and transport only in the original packaging.
Storage and shipment only with an empty Defrosted Water Container.
Operating: Temperature: 0°C - 35°C
Pressure: 700 – 1200 hPa
Steady humidity level from 30 % to 95 %.

Evaporator
temperatures: Minimum (Standby) - 20°C
Maximum (Standby) - 10°C

Treatment Data

Air temperature at nozzle average: - 8°C

(ambient temperature 25°C at start of treatment: - 10°C
or less): maximum: - 5°C (after 15 min. treatment)
Precision of values +/- 10 %.
Maximum treatment time 99:59 min.
setting:
Physical Data:

Weight: 35,5 kg
External dimensions: 650x335x600mm (HxWxL)
Castors:  75mm
Maximum load to be Equipment (e.g. lasers) with a maximum weight of 30kg and maximum dimensions
placed on the glass plate 36x37x48cm (WxDxH) may be placed on any plate affixed with the standoffs.
surface

All specifications subject to alteration!

19
 Cleaning and Disinfection 10.

 Clean the exterior of CryoMini with a commercially available synthetic cleaner

! or furniture polish (but not alcohol-based).

 Alcohol is recommended for the glass plate surface and the treatment tube.

 To disinfect the unit and its attachments, use commercially available equipment
disinfectant in accordance with its manufacturer’s instructions.

 The Defrosted Water Container should be disinfected each time it is emptied

using a commercial disinfectant.

20
Treatment and Application 11.
Suggestions

 To treat larger areas, the distance from the nozzle to the skin should be
increased, resulting in longer treatment times for adequate cooling.

 The cooling spot covers app. 10cm2 at a distance of 5cm

 Hygienic gloves should be worn during the treatment.

 The purpose and effect of cryotherapy using CryoMini should be explained to

the patient before treatment.

 Advise the patient to report any adverse reactions during treatment (e.g.
extreme cold sensations) immediately to the practitioner.

 The practitioner should check the wellbeing of the patient by asking appropriate
questions throughout the treatment.

 If necessary, adjust the treatment parameters (air flow rate, distance from
treatment area).

 For use in conjunction with laser equipment, a distance of 2 inches (5cm) is

recommended for a treatment area of 4 square inches (10cm²). Larger areas
should be treated using a correspondingly larger distance. In such cases, a
longer treatment time is necessary to achieve the required cooling

21
 Parts and Accessories 12.

Only authorized parts and accessories should be used.

Standard Delivery 1 Light treatment tube, woven version

2 Castors  75 mm
2 Castors  75 mm with brake
4 Castor guards
1 Plexiglas plate
1 Defrosted water container
1 Mains cable Europe
1 Instruction Manual

Accessories available Art.Nr.*

upon order
95852210 Light treatment tube, woven version
65373510 Adapter without clip
95372620 Adapter with 20 mm clip
93852660 Am for light treatment tube
80026510 Defrosted water container
80400751 Castor  75 mm (standard)
80401000 Castor  100 mm
80400754 Castor  75 mm with brake (standard)
80401001 Castor  100 mm with brake
65850410 Castor guard
65490610 Plexiglas plate
67300124 Mains cable Europe
98851710 Mains cable England

Only authorized parts and accessories should be used.

All specifications subject to alteration!

22
 Safety 13.

CryoMini is manufactured in accordance to VDE 0750 part 1(DIN EN 60601-1)

safety regulations.
As the manufacturer, Zimmer MedizinSysteme GmbH assumes responsibility for
the safety and reliability of the unit only on the following conditions:

 that the unit is supplied from an electrical socket with safety contact that meets
all regulations and the electricity supply conforms to DIN VDE 0100 part 710

 that the unit is operated in accordance with the Instruction Manual

 that any expansions, readjustments or modifications are carried out exclusively

by personnel acting on behalf of Zimmer MedizinSysteme GmbH.

The unit contains no user serviceable parts, with the exception of the Air Filter (7,
chapter 8.1, page 15) and the Defrosted Water Container (6, chapter 8.2, page 15).

Functional test CryoMini performs an automatic self-test when switched on and checks the
operation of its various components.
If necessary, the operation of the cooling system may also additionally be checked
as follows:

1. Switch on the unit.

2. Wait until the Precooling Phase is complete and the start screen is
displayed. (see Adjustments, Settings and Menus).

3. Press the Start/Stop button (15) to start operation.

4. Select the various air flow levels and check the air flow rate and
cooling achieved.

Please observe any national regulations for recurrent check.

23
Error Messages and Signals 14.

Error messages and signals appear in text form on the display; in some cases, a
possible cause is indicated.

In some cases, the error is self-correctable after the device has been switched-off.
In this case, wait a few seconds and switch the device back on.

If the error indication is still displayed after switching the device back on, contact
customer service.

In the event of Error “High temperature cooling circuit”, switch off the device and
wait 10 minutes before switching on again.

Certified Service Personnel can be reached by contacting the sales representative

or by contacting Zimmer MedizinSysteme directly.

When the expulsed air or air volume temperature decreases, defrosting is

necessary.

24
Disposal 15.

The unit must be disposed of through an authorized and accredited company and
should under no circumstances be placed in the ordinary or bulk waste.

25
 EMC Manufacturer’s Declaration 16.

Medical electrical devices, such as CryoMini, are subject to special precautionary measures with regard to EMC
(electromagnetic compatibility) and must be installed and put into service in accordance with the EMC instructions
contained in the operating instructions or the accompanying papers.

Portable and mobile HF communication devices (e.g. mobile telephones, cellphones) can influence medical electrical
devices.

CryoMini may be operated only with the original parts stated in the list of the scope of supply and accessories. Operation
of the device with other parts can lead to increased emissions or reduced interference immunity of the device!

Guidance and manufacturer’s declaration – Electromagnetic emissions

The CryoMini device is intended for use in the electromagnetic environment specified below. The customer or the
user of the CryoMini device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - Guidance

RF emissions to CISPR 11
Group 1 The CryoMini device 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 to CISPR 11
Harmonic emissions to IEC 61000-3-2
Voltage fluctuations / flicker emissions to
IEC 61000-3-3
Class B The CryoMini device is suitable for use in all
establishments, including domestic
Class A establishments and those directly connected
to the public low voltage power supply
Complies network that supplies buildings used for
domestic purposes.

The device may not be used directly next to other devices or arranged stacked with other devices. If operation is
required close to other devices or stacked with other devices, the device should be observed to check its operation in
accordance with the regulations in this used arrangement.

26
 EMC Manufacturer’s Declaration 16.

Guidance and manufacturer’s declaration – Electromagnetic immunity

The CryoMini device is intended for use in the electromagnetic environment specified below. The customer or the user of the
CryoMini device should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – Guidance

Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic

(ESD) to IEC 61000-4-2 tile. If floors are covered with synthetic
± 8 kV air ± 8 kV air material, the relative humidity should be at
least 30%.

Electrical fast transient / ± 2 kV for power ± 2 kV for power Mains power quality should be that of a typical
burst to IEC 61000-4-4 supply lines supply lines commercial or hospital environment.

± 1 kV for input / ± 1 kV for input /

output lines output lines

Surge IEC 6100-4-5 ± 1 kV differential ± 1 kV differential Mains power quality should be that of a typical
mode mode commercial or hospital environment.

± 2 kV common mode ± 2 kV common

mode

Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typical
interruptions and voltage (>95% dip in UT for (>95% dip in UT for commercial or hospital environment. The user
variations on power supply 0.5 cycle) 0.5 cycle) of the CryoMini requires continued operation
input lines IEC 61000-4-11 during power mains interruptions. It is
40% UT 40% UT recommended that the CryoMini be powered
(60% dip in UT for 5 (60% dip in UT for 5 from an uninterruptable power supply or a
cycles) cycles) battery.

70% UT 70% UT
(30% dip in UT for 25 (30% dip in UT for 25
cycles) cycles)

<5% UT <5% UT
(>95% dip in UT for 5 (>95% dip in UT for 5
seconds) seconds)

Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should be at
Hz) magnetic field to IEC levels characteristic of a typical location in a
61000-4-8 typical commerical or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.

27
 EMC Manufacturer’s Declaration 16.

Essential features of the CryoMini are: Troublefree delivery of cold air as well as troublefree operation of all functions.

Guidance and manufacturer’s declaration – Electromagnetic immunity

The CryoMini device is intended for use in the electromagnetic environment specified below. The customer or the user of the
CryoMini device should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - Guidance

Conducted RF 3 Vrms 3 Vrms Portable and mobile radio devices should be

disturbances to IEC 150 KHz to 80 MHz 150 KHz to 80 MHz used in no smaller distance to the CryoMini
61000-4-6 including the cables than the recommended
protective distance that is calculated according
Radiated RF 3 V/m 3 V/m to the equation appropriate for the transmission
disturbances to IEC 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz frequency.
61000-4-3
Recommended protective distance:

d= 1.17 √P

d= 1.17 √P for 80MHz to 800 MHz

d= 2.33 √P for 800 MHz to 2.5 GHz

with P as nominal power for the transmitter in

watts (W) according to data of the transmitter
manufacturer and d as recommended protective
distance in meters (m).

The field strength of stationary radio transmitters

should at all frequencies according to an
examination on sitea be less than the
compliance levelb.

Disturbances are possible in the environment of

devices that bear the following symbol:

NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 This guidance may not be applicable in all cases. The propagation of electromagnetic disturbance is influenced by
absorption and reflection of the buildings, objects and persons.

28
 EMC Manufacturer’s Declaration 16.

a The field strength of stationary transmitters, such as base stations of radio telephones and mobile land radio
devices, amateur radio stations, AM and FM broadcasting and television transmitters cannot be accurately predetermined
theoretically. To determine the electromagnetic environment with regard to stationary transmitters, a study of the
electromagnetic phenomena of the location should be considered. If the measured field strength at the location at which the
CryoMini device is used exceeds the above compliance level, the CryoMini device should be observed to verify operation
according to the regulations. If unusual features are observed, additional measures can be required, such as a changed
alignment or another location of the CryoMini device.

b The field strength should be less than n 3 V/m over the frequency range from 150 kHz to 80 MHz.

Recommended protective distances between portable and mobile RF telecommunication devices and the CryoMini device

The CryoMini device is intended for operation in an electromagnetic environment in which the RF disturbances are controlled. The
customer or the user of the CryoMini device can help to avoid electromagnetic disturbances in that it complies with the minimum
distance between portable and mobile RF telecommuncation devices (transmitters) and the CryoMini device – depending upon the
output power of the communication device, as stated below.

Nominal power of the transmitter Protective distance depending upon the transmission frequency
W M

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d= 1.17 √P d= 1.17 √P d= 2.33 √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.67 11.67 23.33

For transmitters the maximum nominal power of which is not stated in the above table, the recommended protective distance d in
meters (m) can be determined using the equation belonging to the relevant column, whereby P is the maximum nominal power of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 This guidance may not be applicable in all cases. The propagation of electromagnetic disturbance is influenced by
absorption and reflection of the buildings, objects and persons.

29
 JP (GB), 100V, 10 101 968 UR 0610 I version 1 I Right of modifications reserved
CryoMini
Operating Instructions

Zimmer MedizinSysteme GmbH

Junkersstrasse 9
D-89231 Neu-Ulm
Tel. +49 731. 97 61-291
Fax +49 731. 97 61-299
export@zimmer.de
www.zimmer.de