Zimmer Cryo 6 Instructions For Use Manual

Instructions for Use

Cryo 6

EN

Illustrations

Front of the device

Fig. 1

Device and

operating elements

1

Castors

2

Castor guards

3

Control panel

4

Shelf plate

5

Treatment tube connection

6

Treatment tube

7

Defrost water container

8

Defrost opening

1

2

4

5

6

8

3

7

Illustrations

Rear of the device

Fig. 2

Device and

operating
elements

9

Air filter

10

Mains switch

11

Mains connection

12

Identification plate

9

10

11

12

Illustrations

Screens and display

Fig. 3

OK Start/ Stop

10:00

P2

7

P

P

Operating

elements display

13

OK key

14

Arrow for navigation / changing parameters

15

Arrow for navigation / changing parameters

16

Arrow for navigation / changing parameters

17

Arrow for navigation / changing parameters

18

Start/stop key

Fig. 4

OK Start/ Stop

10:00

P2

7

P

P

Display views

19

Program view

20

Airflow level display (graphical)

21

Airflow level display (numerical)

22

Treatment time display (graphical)

23

Treatment time display (numerical)

14

15

13

16

17

18

192021

22

19.1

23

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

max. permitted load on glass plate 35 kg

Follow instructions for use.

Instructions for use

Serial number

Item number

Manufacturer

Date of manufacture

Max 35kg/

77.16lb

Content

Illustrations

Front of the device
Rear of the device

Screens / display

Explanation of symbols

Page

1.

Indications / Contraindications

1.1 Indications / Contraindications for Cryo 6 Physio

1.2 Indications / Contraindications for Cryo 6 Derma

1
2

2.

Side effects 3

3.

Application information

3.1 General

3.2 Cryotherapy

4
5

4.

Warnings 6

5.

Cryo 6 – in brief 7

6.

Intended use 8

7.

Device set-up

7.1 Fitting

7.2 Fitting the supporting arm

9

11

8.

Default settings

8.1 Configuration menu

8.2 Device type and device configuration

8.3 Default settings and service

8.4 Defrosting

8.5 Own programs and favourites

8.6 Information and maintenance programs

15
16
17
18
19

20

9.

Operating instructions

9.1 Device description

9.2 Performing cryotherapy

9.3 Start-up screens

9.4 Pre-set parameters / change

21
22
23
24

Content

10.

Technical information 25

11.

Cleaning / Disinfection 26

12.

CE mark / manufacturer 27

13.

Scope of delivery and accessories 28

14.

Device combinations 30

15.

Safety and maintenance

15.1 Safety

15.2 Maintenance

31
32

16.

Functional test 33

17.

Safety check / metrological check 34

18.

Error messages / troubleshooting / disposal 35

19.

EMC declaration 37

These instructions for use are an integral part of the device.
They must be stored with the device and kept accessible at all times for anyone authorised to operate this device.

The instructions for use are valid as of November 2016.

Indications / Contraindications

1.1 Indications / Contraindications for Cryo 6 Physio

1

Page 1

Indications

Cryo 6 Physio is designed for the following uses:

x Reduction of pain and stiffness and to support treatment of acute and chronic

painful conditions of the musculoskeletal system

- Arthritis

- Bursitis

- Tendinitis

- Tenosynovitis

- Myositis

- Fibrositis

- Muscle tenseness

- Cervical syndrome

- Post-whiplash disorders

- Lumbar syndrome

- Muscle or joint injuries

x Pain reduction, improved mobility and reduction of joint stiffness in rheumatic

conditions

- Rheumatoid arthritis (progressive chronic arthritis)

- Post-synovectomy condition

x Reduction of spasticity in neurological disorders

- Multiple sclerosis

- Post-apoplectic hemiplegia

other possible uses:

x to support movement therapy by prior cooling
x in combination with compresses in acute injuries
x to prevent oedema and haematoma
x in sports, as preventive early-stage treatment before the development of pain

immediately after major exertion, such as after a competitive event

x to treat muscular trigger points in combination with stretching

Other indications must be discussed with the patient’s doctor or derived from

relevant specialist literature.

Absolute

contraindications

x Cryoglobulinaemia

x Cold agglutinin disease and cold haemolysis
x Cold urticaria
x Parts of the body with impaired circulation
x Raynaud’s disease
x Parts of the body with impaired sensitivity
x Trophic disorders

x Hypersensitivity to cold

Relative

contraindications

x When treating children, parts of the body that are not being treated must be

covered and kept warm.

x When treating the face, the eyes must be covered.
x Do not treat the face or trunk if the patient has severe arterial hypertension and

severe cardiac insufficiency.

x The patient should not become excessively cold during treatment.

Indications / Contraindications

1.2 Indications / Contraindications for Cryo 6 Derma

1

Page 2

Indications

Cryo 6 Derma is designed for the following uses:

Reduction of pain and inflammation by cooling with cold air during and after
dermatological and cosmetic treatments

x Laser therapy
x Injections

x Photodynamic therapy

Advantages

The analgesia associated with cold air makes the treatment much more pleasant for

the patient.

Reduction in the side effects that are often related to laser treatment:

x less erythema
x fewer swellings and encrustations

x reduction of pain and thermal skin damage

Absolute

contraindications

x Cryoglobulinaemia

x Cold agglutinin disease and cold haemolysis
x Cold urticaria
x Parts of the body with impaired circulation
x Raynaud’s disease
x Parts of the body with impaired sensitivity
x Trophic disorders

x Hypersensitivity to cold

Relative

contraindications

x When treating children, parts of the body that are not being treated must be

covered and kept warm.

x When treating the face, the eyes must be covered.
x Do not treat the face or trunk if the patient has severe arterial hypertension and

severe cardiac insufficiency.

x The patient should not become excessively cold during treatment.

Note:

When using Cryo 6 with ablative lasers, make sure that the wound produced is given
appropriate antiseptic care after the treatment.

Side effects

2

Page 3

Side effects Cold-related skin damage such as skin reddening and even mild frostbite and

chilblains can occur, especially in sensitive patients.

Application information

3.1 General

3

Page 4

Prior to using the device on a patient, the user should become familiar with the

instructions for use and individual treatment methods to be used as well as the
indications / contraindications, warnings and application information. Additional

sources of information about the treatment should be followed.

These instructions for use must always be stored with the device and kept
accessible at all times for anyone authorised to operate this device.

Caution

!

After the device has been in transit on its side, place it upright and keep it in an

upright position for at least 30 minutes before switching it on. Otherwise the

compressor will be damaged.

Caution

!

Before use, ensure that the device is powered via a properly grounded mains socket

(electrical installation according to DIN VDE 0100 Part 710). The device must only
be operated with the supplied power cable. The power cable must be protected

against mechanical stress.

Caution

!

Magnetic and electrical fields can affect the function of the device. For this reason,

do not operate Cryo 6 in the vicinity of devices which generate strong
electromagnetic fields (X-ray or diathermy equipment, MRI machines). Please keep

a safe distance of several meters.

Caution

!

Cryo 6 is not suitable for use in areas with an explosive, flammable or combustive

atmosphere.

Caution

!

Do not place the device adjacent to heat sources (heating, hot mud products, sauna

etc.), and leave a gap of at least 50 cm between the device and a wall (to allow for
the supply of treatment products and cold air).
When used in combination with a laser device, the laser ventilation system must not

impede Cryo 6 cooling.

Caution

!

During use, the device is to be located in a position allowing direct access to the

device´s central mains supply so that it can be disconnected from the mains at any

time.

Caution

!

To avoid the risk of electric shock, the plug must be disconnected from the power

supply before performing any cleaning or maintenance activities.

Caution

!

Inspect the device before use. If there is any damage, it must not be used.

Caution

!

Only accessories provided by Zimmer MedizinSysteme GmbH must be used.

Application information

3.2 Cryotherapy

3

Page 5

Patients should be given an explanation of the aims and effects of cold air therapy

with Cryo 6 prior to treatment.

Tell patients that if they experience any discomfort, such as a sensation of extreme
cold during treatment, they must tell the therapist immediately.
During treatment, the therapist should ask patients if they are feeling all right.
The treatment parameters (airflow level and distance from area being treated)

should be adjusted if necessary.

Use the most appropriate nozzle for the various applications, from treatments

administered to large areas of the body through to trigger point treatment. Simply

unscrew a nozzle and screw in a different one when you want to switch.

Short distances between the skin and the nozzle are suitable for brief cooling:

x 1 cm distance for treatment times of up to 10 seconds,
x 5 cm distance for treatment times of up to 30 seconds.

Medium distances between the skin and the nozzle are suitable for dynamic cooling
of larger areas of skin and static cooling of smaller areas:

x 10-15 cm distance for treatment times of approximately 15-30 minutes.

Long distances between the skin and the nozzle are suitable for dynamic cooling of
large areas of skin:

x 15-20 cm distance for treatment times of over 30 minutes.

Longer treatment times are needed for joints and muscles, as otherwise only the

surface and upper layers of the skin are cooled. In patients with joint inflammation,

brief cooling causes reactive hyperaemia.

In patients with diseases of the musculoskeletal and support systems, best results

are obtained with a distance of 5-20 cm between the outlet nozzle and the surface of
the skin.

When used in conjunction with laser devices, a distance of 5 cm for a treatment area
of 10 cm² is recommended. The distance should be increased when treating larger

areas. A longer treatment period is needed to obtain adequate cooling.

Please note that the temperature of the air stream can increase during prolonged
treatment.

Cold air output can be reduced if the environmental conditions are unfavourable
(room temperature over 30°C and high air humidity).

Warnings

4

Page 6

The patient must not be left unattended during therapy.

Any treatment instructions regarding treatment location, duration and intensity

require medical knowledge and should be given by authorised physicians, therapists

and health paraprofessionals. These instructions must be followed.

Use in wet areas is not permitted and may in case of non-compliance lead to
considerable damage and endanger both the patient and the user.

Dispose of the packaging material properly. Make sure that it is not accessible to
children.

The cold air stream must not be applied to open wounds.

When using Cryo 6 to cool skin, do not increase the output of the laser device
beyond the level recommended by the manufacturer.

When applying cold to the face it is essential to protect the eyes.

The air stream should be directed evenly over the area to be treated. Avoid static or
excessively intensive cooling as this can lead to cold burns and hypothermia.

The use of the device out of the settings or applications specified in the instructions
for use may lead to hazard by the uncontrolled effects of cold.

Children can become too cold. Parts of the body that are not being treated should be

covered and kept warm. This is also recommended for adults undergoing prolonged

cooling.

Frostbite can occur if the skin temperature falls to 0°C or below This can occur if the

nozzle is less than 10 cm away from the skin. If it is not possible to respect this
distance on therapeutic grounds, it is recommended that the nozzle be directed

dynamically over the area being treated.

Do not push the sides of the device that are marked with the warning symbol.

Do not lean on the device.

Cryo 6 - in brief

5

Page 7

What is Cryo 6?

A compact cold-air device used to treat diseases of the support and

musculoskeletal systems.
Cryo 6 can also be used to cool the skin of patients undergoing dermatological laser

treatment to relieve pain and thermal skin damage.

What does Cryo 6 do?

It blows very cold air onto the parts of the body to be treated at various speed
settings.

What are the benefits

of Cryo 6?

It is very easy to use thanks to the pre-set program parameters and also very

powerful in prolonged use, matching the performance of much larger devices.

What are the other

benefits of
Cryo 6?

Its clear LCD display and ergonomic keyboard reflect the state of the art.

Therapy can be customised through six user-focused, pre-set programs as well as
three programs with free choice of settings and an individual start-up program.

How is the necessary

concentration of cold
achieved?

Air volume can be set to one of nine levels depending on the size of the area to be

treated and how accessible it is.
Three nozzle sizes are supplied as standard for individual therapy (diameters of 5,
10 and 15 mm).

A special nozzle is also available for cooling the skin of patients undergoing
dermatological laser treatment.

Note:

Use of the device is reserved for medical professionals
(such as physicians, therapists, medical paraprofessionals).

Intended use

6

Page 8

The Cryo 6 cold air device is used to cool skin

- when treating injuries or diseases affecting the musculoskeletal system

- in order to reduce local pain

- in patients undergoing dermatological laser treatment to prevent thermal skin

damage

Device types

1. Cryo 6 Physio to treat diseases of the support and musculoskeletal systems.

2. Cryo 6 Derma to cool the skin of patients undergoing dermatological laser
treatment to relieve pain and thermal skin damage.

The device types are preconfigured in the factory and differ in respect of the pre-set

fan settings and treatment periods as well as the start-up program.

Device set-up

7.1 Fitting

7

Page 9

Caution

!

Cryo 6 must be placed upright and kept in an upright position for at least 30 minutes

before being switched on if the device has been transported on its side or had fitting
work done on it.

Otherwise the compressor could be damaged.

Connect power cable

Connect the power cable to the provided port (11) on the device and connect the
cable to the mains.

Note:

The device may only be connected to power outlets with a protective contact

Switching device on

The device is switched on using the toggle switch (10).

Switching device off

The device is switched off using the toggle switch (10).

To fully (all poles) disconnect the device from the mains, the power cable must be

disconnected.

Caution

!

All cables must be protected from pinching or other mechanical damage.

Fitting the treatment

tube

Insert the treatment tube into the connector (5) on the front of the device and lock it

into place.

The treatment tube can be stored in the curved groove above the control panel (3)

when not in use.

Fitting the castor
guards

Attach the castor guards (2) to the wheel holders.

Fitting the glass plate

Four spacing bolts are already fitted to the top of the device to allow the glass plate

to be attached.

Place a silicon intermediate disc onto each of the four spacing bolts.

Then put the glass plate on the spacing bolts.

Now secure the glass plate by screwing one of the clamp bearings provided into
each of the four spacing bolts.

You do not need to use a tool for this, in order to prevent damage to the glass plate.

Use your fingers to tighten the clamp bearings.

Device set-up

7.1 Fitting

7

Page 10

Carry out the steps described above in reverse order to dismantle the glass plate.

Never lift the device by the glass plate.

Note:

The treatment nozzle and the nozzle attachments can be kept in the storage box.

Glass plate

Clamp

bearing

Silicon disc

Spacing bolt

Device set-up

7.2 Fitting the supporting arm

7

Page 11

Supporting arm

The Cryo 6 device can be fitted with a supporting arm as an extra option.

This arm allows a particular part of the body to be cooled without
the therapist having to hold the tube.

The supporting arm accessory kit consists of:
1 supporting arm mounting bracket
2 M6x16 screws and allen key for mounting
1 anti-rotation element
1 supporting arm pole
1 rotating supporting arm
1 tube clip
1 tube holder

Also required:
Glass plate

Guide sleeve

Picture of the

supporting arm after

fitting

supporting arm

Guide through
glass plate and
anti-rotation
element

Supporting arm
pole

Supporting arm securing element

Device set-up

7.2 Fitting the supporting arm

7

Page 12

Fitting instructions

The glass plate must be attached to the device so that a supporting arm can be fitted

(see 7.1 Fitting) The glass plate contains an opening through which the supporting

arm passes.

Note:

The glass plate can be fitted so that it is symmetrical with the device. If a supporting

arm is also fitted, the glass plate is laid on the spacing bolts in such a way that the

hole for positioning the supporting arm is on the correct side of the device.

Step 1 - fitting the guide sleeve

Assemble the guide sleeve (supplied with the glass plate) in the hole made for this
purpose.

Step 2 - fitting the supporting arm securing element

Use the Allen key and the M6x16 screws to screw the mounting bracket to the base
of the device.
Threaded holes are already in place on the base of the device for this purpose.

Caution

!

The view from below is only presented for clarification, please DO NOT put the

device down for fitting!

Threaded
holes

Guide sleeve
Part 1

Guide sleeve
Part 2

Device set-up

7.2 Fitting the supporting arm

7

Page 13

Step 3 - attaching the anti-rotation element and pole

Place the anti-rotation element on the glass plate spacer as shown in the picture.

Then pass the supporting arm pole through the guide sleeve and the anti-rotation
element from above, and lock it into place in the supporting arm securing element.

Anti-rotation

element

Device set-up

7.2 Fitting the supporting arm

7

Page 14

Step 4 - attaching the supporting arm

Screw the supporting arm (a) onto the fitted pole. The recesses must be aligned in
order to ensure that the supporting arm can move freely up and down. They must lie
along an axis and allow the pole to bend.

Step 5 - attaching the tube clip / tube holder

Screw the tube clip (b) onto the rotating supporting arm, and hang the tube holder (c)
onto the fixing screw of the supporting arm.

The treatment tube can now be passed through the tube securing element and the

handpiece can be engaged in the tube clip.

- Recesses below

- Same bend orientation

Settings

8.1 Device menu

8

Page 15

The Cryo 6 performs a self-test once it has been switched on.

You can switch to the configuration menu during the self-test and subsequent pre-

cooling of the device.

Selecting the menu

Press the “Menu” key to select the menu.

You can use the menu to call up technical information, change factory settings,
select a favourite program or define your own programs.

You can choose from eleven menu items:

- Service

- Back to treatment

- Defrost

- Own programs

- Favourite

- Info

- Automatic maintenance program S01

- Automatic maintenance program S02

- Cryo device type

- Device configuration

- Basic settings

Use the arrows (14 and 15) to navigate among the individual menu items.

Selecting menu items

Press the “Select” key (17) to select a menu item.

End menu

Select the “Back to treatment” menu item to end the menu and return to the
treatment screen.

Settings

8.2 Device type and device configuration

8

Page 16

Device type

Cryo 6 can be used as “Cryo 6 Physio” or “Cryo 6 Derma”.

Use the arrows (14 and 15) to navigate to the pre-set configuration that you want to
use. Then press the “Save” key to select it.

See chapter 9.3 for more information about device types and specific parameters.

Device configuration

This menu item offers various settings, such as languages or aspects of the start-up

process.
Use the arrows (14 and 15) to navigate through the sub-menu.

Press the “Select” key (17) to select an item.

Languages

The following languages are available:

German, English, French, Italian and Polish.

Note:

The “External control input”, “External control output” and “External start input” sub­menus are inactive.

Start-up process

Cryo 6 offers two different options here:

1. Direct start

2. Programs
Press the “Select” key to select the menu.
Press the “Change” key to switch between direct start and programs.
Press the “Save” key to save the start-up process you want to run and the “Yes” key

to confirm and apply your choice.

Settings

8.3 Default settings and service

8

Page 17

Default settings

You can restore factory settings under this menu item.

Press the “YES” key to reset all the parameters that have been changed back to the
factory settings.

Own programs and the favourite program that you have saved will not be lost.

Press the “NO” key to retain changed parameters.

Service

This area is password-protected and is only accessible to people who have been

trained by Zimmer MedizinSysteme GmbH.

Press the “OK” key to quit the menu.

Settings

8.4 Defrosting

8

Page 18

Defrost

The “Defrost” menu item triggers defrosting of the heat exchanger.

Note:

Perform defrosting when the outgoing air stream is less strong than usual. This is

often caused by the Cryo 6 being placed in a humid environment such as a bathing
area or sauna. We also recommend defrosting the Cryo 6 and emptying the defrost
water container if it has not been used for a prolonged period, for instance during

holidays.

Performing defrosting

Press the “Select” key to immediately begin the defrosting process. The defrosting
process is carried out in standby mode.

The treatment fan starts up and runs until the cooling unit’s defrosting temperature

has been reached. The blower then switches off.

The message “Defrost complete” appears on the display once the defrosting process
has been completed.

Press the “Back” key if you want to interrupt the defrosting process before it has

finished.

Settings

8.5 Own programs and favourites

8

Page 19

Note:

The “Internal programs”, “Programming of 1 and 2-phase programs” and “Favourite

program” can only be activated if “Programs” is activated as the start-up process

(see point. 8.2).

Own programs

Cryo 6 offers storage options for three own programs in addition to the six factory

pre-set programs which cannot be permanently changed.
Fan level and time can be allocated individually to a storage location.
The programs can be programmed either for one phase or for two consecutive

phases.

Programming a

1-phase program

Use the arrows (14 and 15) to navigate among the three storage locations.

Press the “Select” key (17) to select the stored program that you want to use.

You can then use the arrows (15 and 16) to select the desired fan level. The fan
symbol (20) flashes.
Press the “Save” key to save the fan level.
The fan symbol now stays lit and the time symbol (22) flashes.

Use the arrows (14 and 15) to select the desired time.
Press the “Save” key to save the time.

Activate the “Back” key to stop programming the 1-phase program. Press the “Back”

key to quit the menu.

Programming a

2-phase program

Here you can arrange for two programs with different fan levels and times to run

consecutively in a single treatment session.
Start in the same way as when programming a 1-phase program. Now, instead of
pressing the “Back” key to quit the program, press the “Save” key again. The

parameters for phase 1 now appear in small font at the top of the display.

Favourite

Here you can select a personal favourite program that is automatically loaded

whenever the device is started up. You can choose one of the six factory pre-set
programs P1-P6 or one of the own special programs S1-S3. Use the arrows (14 and

15) to navigate among the program locations. Choose the program you want to

define as the favourite and press the “Select” key to confirm.

Settings

8.6 Information and maintenance programs

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Page 20

Info

Technical information about various device components is displayed under this
menu item.

Note:

No settings can be applied.

Maintenance programs

The S01 and S02 maintenance programs simulate long-term operation and logs the

correct condition of the device.

Any faults are diagnosed and recorded.

SO1

This program simulates two 15-minute treatment sessions and one defrosting

process. The program records key parameters such as temperature and duration.

The current temperatures of the compressor and evaporator can be checked during

the test.

SO2

The device cools down to - 43°C / - 38°C and starts a 15-minute treatment session

at fan level 9.

This program is repeated until the start/stop key is pressed.

Operation instructions

9.1 Device description

9

Page 21

Pre-cooling

As soon as Cryo 6 is switched on, the device starts to pre-cool to the minimum

temperature to be reached. The compressor and condenser fan work together during
this phase. At the same time the device performs a self-test. No data can be entered
via the display during the self-test or pre-cooling. The only active key is the “Menu” key
(1), which users can press to reach the configuration menu. When sufficient pre­cooling has been carried out, the display automatically switches to the start screen.

Cryo 6 is now ready for use.

Operation

During treatment, the treatment fan blows cold air through the treatment tube. At the

same time, the compressor / condenser starts up automatically during treatment in

order to ensure constant cooling.

Standby mode

Cryo 6 is in standby mode when no treatment is being carried out. The compressor

automatically starts up as soon as a certain temperature is exceeded, in order to
ensure that sufficient cold air is available at all times. Treatment can be started

immediately from standby mode.

Recommendation for

optimum
treatment

We recommend that about 10 minutes should be left between the end of pre-cooling

and the start of treatment. This ensures that the device has reached peak cold air
output.

We also recommend that Cryo 6 is only switched off when there are prolonged breaks

in treatment or at the end of the day.

1

Operation instructions

9.2 Performing cryotherapy

9

Page 22

Switching device on

Switch on the device at the mains switch (10), display lights up.

Initialisation

The current status (self-test, pre-cooling) can be read off at the display during
initialisation.

Note:

The factory settings mean that the start-up screen and start-up process are different

depending on whether you are using the device with the Cryo 6 Physio or Cryo 6
Derma pre-set parameters.

See the next page for illustrations of both start-up screens.

Selection

Program and treatment
time

The device is ready to use as soon as the treatment screen (in this case “Physio”)

appears.

OK Start/ Stop

10:00

P2

7

P

P

Use the program selection keys (14 and 15) to set the desired treatment program

and the timer keys (16 and 17) to set the desired treatment time.

Note:

The fan level cannot be altered before the start of treatment.

Start of treatment

Press the start/stop (18) key to start the program running.

The fan level (14 and 15) and treatment time (16 and 17) can be altered by pressing
the corresponding keys during treatment.

7

05:30

OK Start/ Stop

Note:

If parameters are altered during treatment, the factory settings are restored after the

end of treatment (or the favourite program settings if a favourite program has been

stored).

End of treatment

An acoustic signal indicates the end of treatment, and the fan is automatically

switched off. This also applies to premature interruption of treatment via the

start/stop key (18).

Operation instructions

9.3 Start-up screens

9

Page 23

Start-up screens

The factory settings mean that the start-up screens and start-up process of the
Physio and Derma versions are different.

Derma start-up screen / direct start

7

05:30

OK Start/ Stop

Direct start: Fan level and time can be selected directly.

Physio start-up screen / programs

OK Start/ Stop

10:00

P2

7

P

P

Programs: direct selection option among various

pre-set programs and the use of

interval programs.

Note:

The device configuration menu item offers a free choice of the desired start-up
process. See chapter 8 for instructions.

Operation instructions

9.4 Pre-set parameters / change

9

Page 24

Cryo 6 Physio - pre-set

parameters

Phase 1

Phase 2

Program

Fan level

Time

Fan level

Time

193 min

-

-

265 min

-

-

345 min

-

-

4310 min

-

-

5930 sec

6

2:30 min

671 min

5

4 min

Cryo 6 Derma - pre-set

parameters

Program

Fan level

Time

1745 min

2545 min

3345 min

4815 min

5615 min

6415 min

Note:

Cryo 6 Derma is factory-set for direct start operation. Use the “Device configuration”
menu to switch to program operation.

Changing the pre-set

values

Cryo 6 offers options to adjust the fan level and treatment time to individual

requirements and to save these changes (see chapter 8.5).

The treatment fan can be set to nine levels using the keys (14 and 15).

Treatment time can be set to any duration between 00:00 and 99:59 minutes.

If an excessively high treatment time has been selected by mistake, press the

start/stop key (18) twice to return to the factory pre-set time.

Technical information

10

Page 25

Mains power

100-120 V / 50 Hz / 60 Hz (9-12 A)

220-240 V / 50 Hz (7 A)
240 V / 60 Hz (7 A)

Mains fuse

16 A circuit breaker in mains switch

Protection class

I

Applied part

Type B

Dimensions

H 645 mm x W 390 mm x D 680 mm

Weight

75 kg

Operation

+10°C to +35°C, 20% to 80% relative humidity, without condensation

at 700 hPa to 1060 hPa

Transport

-10°C to +50°C, 10% to 90% relative humidity, without condensation

at 600 hPa to 1060 hPa

Storage

0°C to +40°C, 10% to 90% relative humidity, without condensation

at 600 hPa to 1060 hPa

Note:

Storage and transport only in original packaging.

Evaporator temperature

generated

115 V device

230 V device

minimum (standby)

- 38°C

- 43°C

maximum (standby)

- 25°C

- 25°C

Air output temperature

(room temperature up to
25°C)

average: - 25°C

at the start of treatment: - 31°C
maximum: - 18°C (after 15 minutes of treatment)

Figures accurate to +/- 10%

Max. treatment time that

can be set

99:59 min

Maximum load on glass

plate

The maximum weight and size of devices (such as laser devices) that can be

placed on the glass plate is 35 kg and 50 x 50 x 35cm (W x D x H).

Subject to technical changes.

Cleaning

Disinfection

11

Page 26

- Before starting any maintenance and cleaning measures the device must always

be switched off at the main switch and the mains cable must be disconnected.

- Make sure that when cleaning and disinfecting the labelling of the device (such as
warnings, labels of control devices, identification plate) is not damaged.

- Make sure that during cleaning and disinfection no liquids penetrate the device. Do
not use sprays.

- If during cleaning or disinfecting liquid penetrates the device, please put the device
out of service, protect it from being used again and contact your service
representative.

- The device and its applied part are considered as uncritical in relation to hygiene

due to the use on non-injured and healthy skin.

Housing / accessories

Cleaning: In the event of visible contamination, the housing, cables and accessories

can be cleaned using commercially available alcohol-free plastic cleaners. Wipe the
surface until the dirt is removed, using a soft cloth soaked according to the
specifications of the manufacturer of the cleaning agent but not dripping wet.

Disinfection: We recommend that disinfection is to be carried out at least once a
week, as well as if there is any indication of contamination. Consult with your
hygiene specialist when doing so. Always perform cleaning prior to disinfection.
Housing, cables and accessories can be disinfected using disinfectant wipes. Use a
commercially available alcohol-free disinfectant for metal and plastic, with
bactericidal, virucidal and fungicidal properties. Observe the application instructions
of the manufacturer. Wipe all surfaces using a soft cloth soaked according to the
specifications of the manufacturer of the disinfectant, but not dripping, or with cloths
pre-impregnated with disinfectant (wipes).
Also observe requirements for drying or post-cleaning, where applicable.

Defrost water container

Cleaning: The defrost water container (7) should be cleaned whenever it has been

emptied. Follow the procedure described under "Housing / Accessories".

Disinfection: Follow the procedure described under "Housing / Accessories".

Caution

!

The device may only be operated with the defrost water container in place.

Air filter

The air filter (9) should be cleaned regularly, and in any event after no more than

200 operating hours (maintenance notice appears on the display).
This is done by vacuuming the air filter from the outside using a commercially

available domestic vacuum cleaner.

Note:

Use the device only in a hygienic environment.

CE mark / manufacturer

12

Page 27

The device has a CE mark

in accordance with the EC directive on medical devices 93/42/EEC.

Manufacturer

Zimmer MedizinSysteme GmbH

Junkersstraße 9
D-89231 Neu-Ulm
Tel.

+49 731. 9761-291

Fax [phone]

www.zimmer.de

Scope of delivery / accessories

13

Page 28

Scope of delivery

Version Cryo 6 Physio

Item no.

95850912

1 treatment tube Physio

65370216

1 adapter for nozzles

65370225

1 nozzle  5mm

65370224

1 nozzle  10mm

65370223

1 nozzle  15mm

66850122

1 glass plate with handles

94851511

1 screw Set for glass shelf

80400756

4 plastic castors  75 mm

65851610

1 defrosted water container

67300124*

1 mains cable 230 V

65853112

1 accessory storage tray

10101665

1 instructions for use

Scope of delivery

Version Cryo 6 Derma

Item no.

95853411

1 treatment tube Light Neo

66850122

1 glass plate with handles

94851511

1 screw Set for glass shelf

80400756

4 plastic castors  75 mm

65851610

1 defrosted water container

67300124*

1 mains cable 230 V

65853112

1 accessory storage tray

10101665

1 instructions for use

Optional device castors

80400756

Plastic castors  75 mm

80401004

Plastic castors  100 mm

Subject to technical changes.

* Individual mains cable available. Please contact your distributor.

Scope of delivery / accessories

13

Page 29

Accessories

For both device versions

Item no.

65851610

1 defrosted water container

87413230

Blank plug for defrosted water container

65853112

Accessory storage tray

80400756

Plastic castors  75 mm

80401004

Plastic castors  100 mm

Version Cryo 6 Physio

Item no.

95850912

Treatment tube Physio

65370216

Adapter for nozzles

65370225

Nozzle  5mm

65370224

Nozzle  10mm

65370223

Nozzle  15mm

66850122

Glass plate with handles

93852620

Supporting arm for Physio tube

Version Cryo 6 Derma

Item no.

95853411

Treatment tube Light Neo

65373510

Nozzle for Derma tube

66850112

Glass plate without handles

94851511

Screw Set for glass shelf

93852630

Supporting arm for Derma tube

95855610

Bracket for laser tube

For safety reasons only use original accessories, as proper functioning cannot
otherwise be guaranteed.

Subject to technical changes.

Device combinations

14

Page 30

Cryo 6 can be used in combination with various laser devices. Please comply with

the laser manufacturer’s instructions for use when doing so.

The party combining the devices and thus operating a medical system is
independently responsible for combining the devices correctly.

When using devices in combination, please comply with the safety regulations of
DIN EN 60601-1.

Safety and maintenance

15.1 Safety

15

Page 31

Cryo 6 is manufactured according to the DIN EN 60601-1 safety regulations.

As the manufacturer, Zimmer MedizinSysteme GmbH can only consider itself to be
responsible for the safety and reliability of the device if

x the device is operated using a proper power outlet with earth contact and the

electrical installation complies with DIN VDE 0100 part 710,

x the equipment is operated in accordance with the instructions for use,

x extensions, readjustments or modifications are carried out only by persons

authorised by Zimmer MedizinSysteme,

x the user has confirmed the functional safety and the proper operating condition

for him-/herself before use,

x the device is operated only by properly trained personnel,

x the device is not operated in areas at risk of explosion and / or a combustive

atmosphere, and

x the device is immediately disconnected from the mains when penetrated by

liquid.

The device does not contain any parts that can be repaired by the operator.

Safety and maintenance

15.2 Maintenance

15

Page 32

Cleaning the air filter

There is a filter element on the rear of the device (9) to ensure that the treatment air

and the cold air needed for the cooling machine are free from coarse dust particles.
It is normally sufficient to clean this regularly by vacuuming the whole of the outside
with a commercially available domestic vacuum cleaner, no later than when the
software issues a reminder after 200 operating hours. We recommend cleaning the
filter element more frequently in carpeted rooms or in areas where dust formation is

likely to be higher for other reasons.

Note:

The software message must be confirmed by pressing the “OK” key after the air filter
has been cleaned.

Emptying the defrost

water container

When Cryo 6 is switched off after use, or when the defrosting program is started, the

cooling system heats up and so produces defrost water.
The tank, which has a capacity of approximately 1 litre, can be removed by pulling it
out of the device and can then be emptied.
It should then be replaced in the device.

Please also follow the instructions for cleaning and disinfection (chapter 11).

Functional test

16

Page 33

Functional test

After being switched on, Cryo 6 automatically performs a self-test and checks the

function of the technical components.

If necessary, the user can check the function of the cooling technology as described
below:

1. Switch on the device.

2. Wait until the device is ready for use.

This is the case when the device displays the program selection menu /
direct start menu.

3. Press the start/stop key (18) to start up Cryo 6.

4. Select the various airflow levels one after the other and check the strength

of the air stream and the cold air output.

Safety checks

Metrological control

17

Page 34

In Germany, no safety checks according to section 6 of the MPBetreibV (Medical Device

Operator Ordinance) are required for the device Cryo 6. The device is not listed in

attachment 1 of the ordinance.

A metrological control (MTK) according to section 11 of the MPBetreibV (Medical device

operator ordinance) is also not required for the device Cryo 6. The device is not listed in
attachment 2 of the ordinance.

Note:

These requirements apply to the operation of the device in Germany. Please
consider divergent national regulations in your country.

Error messages

Troubleshooting

Disposal

18

Page 35

Mains fuse

is activated

Cryo 6 is fitted with a bipolar overload protection element integrated into the main

switch (10) to protect the device in the event of supply problems. If the fuse trips, the
device automatically switches off via the toggle switch (10). The device can only be
made ready for use again by switching it on via the toggle switch (10).

Please notify the customer service department if this fault occurs frequently.

Reduced cold air

output / reduction in
cold air output

Dirt in and around the defrost opening (8) may be the cause of a significant reduction

in cold air output and a weak air stream. Dust particles are deposited in the heat
exchanger by the treatment air. This can eventually lead to blockage of the defrost
opening and a build-up of defrost water.

The defrost opening is located above the defrost water container. The device must
be defrosted before cleaning the defrost opening (see page 18, “Performing
defrosting”). After defrosting, switch off the device and remove the plug from the
socket.

Remove the defrost water container and place a flat container underneath the device
to capture the defrost water. Slowly pull out the defrost opening, using a twisting
motion.

Clean the defrost opening under running water and screw it back into place.

Error messages

Device components that are important to the running of programs are tested when

the device is switched on and sometimes also when it is in use. If an error is
detected during these tests, treatment is terminated, and an error message is
displayed in the top line of the display and an acoustic signal is produced.

Error messages are shown in plain text in the top line of the display. Treatment
cannot be continued, the device can only be switched off.

Errors that do not affect continued work with the device can be resolved by switching
the device off, waiting for five seconds and then switching it back on.

If the error message relates to excessively high temperature or pressure, you should
wait for 30 minutes before switching the device back on as the device needs time to
cool down. These error messages may be caused by high external temperatures
and room temperatures which impair cold air output.

OK

Start/ Stop

Excess pressure cold circuit

Error messages

Troubleshooting

Disposal

18

Page 36

Please notify the customer service department if this fault occurs frequently. You

may get in touch with them via your sales representative or via the main office in
Neu-Ulm.

For other functional problems, contact your service representative.

Main office

Zimmer MedizinSysteme GmbH

Junkersstraße 9
D-89231 Neu-Ulm
Tel. [phone]
Fax [phone]

www.zimmer.de

Disposal

The device may only be returned to the factory in its original packaging. It must be

disposed of by the factory in Neu-Ulm.

In foreign (European) countries please refer to national regulations for disposal.

Contact your distributor if necessary.

Manufacturer´s EMC declaration

19

Page 37

Medical electrical devices, such as Cryo 6, are subject to special precautionary measures with regard to EMC
(electromagnetic compatibility) and must be installed and put into operation according to the EMC information in
the instructions for use or accompanying documentation.

Portable and mobile HF communication devices (such as mobile phones, cell phones) can affect medical
electrical devices.

Cryo 6 may only be operated with the original power cable indicated in the list of the scope of delivery and
accessories.
Operation of the device with a different power cable can lead to increased emissions or reduced interference
immunity of the device!

Guidelines and manufacturer's declaration – Electromagnetic emissions

The Cryo 6 device is intended to be operated in an electromagnetic environment as indicated below. The customer
or user of the Cryo 6 should ensure that it is operated in such an environment.

Interference emission measurements

Compliance

Electromagnetic environment - Guideline

HF emissions according to CISPR 11

Group 1

The Cryo 6 device uses HF energy only for its

internal functioning. This means that its HF
emissions are very low, and it is very unlikely
that adjacent electronic devices would suffer

interference.

HF emissions according to CISPR 11

Class B

The Cryo 6 device is suitable for use in all

facilities, including those in a residential area,
and in those which are connected directly to
the public grid which also supplies buildings
used for residential purposes.

Harmonic emissions according to IEC
61000-3-2

Class A

Voltage fluctuations/flickers according to
IEC 61000-3-3

not applicable

The device should not be used in the direct vicinity of or stacked with other devices. If operation near or stacked
with other devices is necessary, the device should be observed to check its proper operation in the arrangement
used.

Manufacturer´s EMC declaration

19

Page 38

Guidelines and manufacturer's declaration – Electromagnetic immunity

The Cryo 6 device is intended to be operated in the electromagnetic environment as indicated below. The customer or user
of the Cryo 6 device should ensure that it is used in such an environment.

Immunity tests

IEC 60601­test level

Compliance
level

Electromagnetic environment - Guidelines

Electrostatic

discharge (ESD)
according to IEC
61000-4-2

± 6 kV contact

discharge

± 8 kV air

discharge

± 6 kV contact

discharge

± 8 kV air

discharge

Floors should be made of wood or concrete or should be covered

with ceramic tiles. If the floor is covered with synthetic material,
the relative air humidity must be at least
30%.

Rapid transient

electrical
disturbances/bursts
according to IEC
61000-4-4

± 2 kV for

power cables

± 1 kV for input
and output

cables

± 2 kV for power

cables

± 1 kV for input
and output

cables

The quality of the supply voltage should correspond to that of a

typical business or hospital environment.

Surges

according to IEC
6100-4-5

± 1 kV

differential
mode

± 2 kV

common mode

± 1 kV

differential mode

± 2 kV common
mode

The quality of the supply voltage should correspond to that of a

typical business or hospital environment.

Voltage dips, brief

interruptions and
fluctuations in the
supply voltage
according to IEC
61000-4-11.

<5% U

T

(>95% dip in
the U

T

for ½

cycle)

40% U

T

(60% dip in the
U

T

for 5 cycles)

70% U

T

(30% dip in the
U

T

for 25

cycles)

<5% U

T

(>95% dip in
the U

T

for 5

seconds)

<5% U

T

(>95% dip in the
U

T

for ½ cycle)

40% U

T

(60% dip in the
U

T

for 5 cycles)

70% U

T

(30% dip in the
U

T

for 25 cycles)

<5% U

T

(>95% dip in the
U

T

for 5

seconds)

The quality of the supply should correspond to that of a typical

business or hospital environment. If the user of the Cryo 6
requires continued function even if interruptions in the power
supply occur, it is recommended to power Cryo 6 from an
uninterruptible power supply or a battery.

Magnetic field at

power supply
frequency (50/60
Hz) according to

IEC 61000-4-8

3 A/m

3 A/m

Magnetic fields at the mains frequency should correspond to the

typical values found in a business or hospital environment.

Note: UTis the a.c. supply voltage prior to application of the test level.

Manufacturer´s EMC declaration

19

Page 39

Key performance features of the Cryo 6 are: smooth output of cold air, smooth operation of all functions.

Guidelines and manufacturer's declaration – Electromagnetic immunity

The Cryo 6 device is intended to be operated in the electromagnetic environment as indicated below. The customer or user
of the Cryo 6 device should ensure that it is used in such an environment.

Immunity
tests

IEC 60601- test
level

Compliance level

Electromagnetic environment - Guidelines

Conducted

HF
disturbances
according to
IEC 61000­4-6

Radiated HF
disturbances
according to
IEC 61000­4-3

3 V

Effective value

150 KHz to 80 MHz

3 V/m
80 MHz to 2.5 GHz

3 V

Effective value

150 KHz to 80 MHz

3 V/m
80 MHz to 2.5 GHz

Portable and mobile radio equipment should not be used

at a distance away from the Cryo 6, including the cables,
that is less than the recommended safety distance which is
calculated according to the equation applicable to the
transmission frequency.

Recommended safety distance:

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with P as the rated output of the transmitter in watts (w)
according to the information of the manufacturer of the
transmitter and d as the recommended safety distance in
meters (m).

At all frequencies, the field strength of stationary radio
transmitter should be less than the compliance level

b

according to on-site testing

a

In the environment of devices which bear the following
symbols, interferences are possible:

NOTE 1 At 80 Hz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromagnetic variables is influenced by

absorption and reflection from buildings, objects and people.

Manufacturer´s EMC declaration

19

Page 40

a

The field strength of stationary transmitters, such as base stations for radio telephones and land mobile radios,

amateur radio stations, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment with regard to the stationary transmitters, an electromagnetic site survey is to be
recommended. If the measured field strength in the location in which the Cryo 6 device is used exceeds the above
compliance level, the Cryo 6 device must be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Cryo 6.

b

Above a frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.

Recommended safety distances between portable and mobile HF telecommunication devices and the Cryo 6 device

The Cryo 6 device is intended to be operated in an electromagnetic environment in which the HF disturbances are controlled.

The customer or user of the Cryo 6 device can help avoid electromagnetic interference by maintaining a minimum distance
between portable and mobile HF telecommunication devices (transmitters) and the Cryo 6 device – depending on the output

power of the communication device as indicated below.

Rated output of the transmitter

W

Safety distance depending on the transmission frequency

m

150 kHz to 80 MHz

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80 MHz to 800 MHz

G ¥3

800 MHz to 2.5 GHz

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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 whose maximum rated output is not listed in the table above, the recommended safety distance d in metres

(m) can be determined using the equation applicable to the respective column, where P is the maximum rated output 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 These guidelines may not be applicable in all cases. The propagation of electromagnetic variables is influenced by

absorption and reflection from buildings, objects and people.

Cryo 6

Zimmer MedizinSysteme GmbH
Junkersstrasse 9
D-89231 Neu-Ulm
Tel. [phone]
Fax [phone]
[e-mail]
www.zimmer.de

Instructions for Use

EN 10 101 665 UR 1216 I Version 4 I Right of modication reserved