Instructions For Use: Cryo 6

Instructions for Use
Cryo 6
EN
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Illustrations
Front of the device

Fig. 1
6
8
Device and 1 Castors

operating elements 2 Castor guards
3 Control panel
4 Shelf plate
5 Treatment tube connection
6 Treatment tube
7 Defrost water container
8 Defrost opening

Illustrations
Rear of the device

Fig. 2
11
10
12
Device and 9 Air filter

operating 10 Mains switch
elements 11 Mains connection
12 Identification plate

Illustrations
Screens and display

Fig. 3
13
P2 7 10:00 18
OK Start/ Stop
P P
14 15 16 17
Operating 13 OK key
elements display 14 Arrow for navigation / changing parameters
15 Arrow for navigation / changing parameters
18 Start/stop key
Fig. 4
19.1
19 20 21 22 23
P2 7 10:00
OK Start/ Stop
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)

Explanation of symbols
In the instructions for use this symbol indicates “Danger”.
In the instructions for use this symbol indicates “Caution” with regard to possible
Caution ! damage of the device.
Applied part type B
do not push sideways
max. permitted load on glass plate 35 kg
Max 35kg/
77.16lb
Follow instructions for use.
Instructions for use
Serial number
Item number
Manufacturer
Date of manufacture

Content
Illustrations
Front of the device
Rear of the device
Screens / display
Explanation of symbols
Page
Indications / Contraindications
1. 1.1 Indications / Contraindications for Cryo 6 Physio
1.2 Indications / Contraindications for Cryo 6 Derma
1
2
Side effects 3
2.
Application information
3. 3.1 General
3.2 Cryotherapy
4
5
Warnings 6
4.
Cryo 6 – in brief 7
5.
Intended use 8
6.
Device set-up
7. 7.1 Fitting
7.2 Fitting the supporting arm
9
11
Default settings
8. 8.1 Configuration menu
8.2 Device type and device configuration
15
16
8.3 Default settings and service 17
8.4 Defrosting 18
8.5 Own programs and favourites 19
8.6 Information and maintenance programs 20
Operating instructions
9. 9.1 Device description
9.2 Performing cryotherapy
21
22
9.3 Start-up screens 23
9.4 Pre-set parameters / change 24

Content
Technical information 25
10.
Cleaning / Disinfection 26
11.
CE mark / manufacturer 27
12.
Scope of delivery and accessories 28
13.
Device combinations 30
14.
Safety and maintenance
15. 15.1 Safety
15.2 Maintenance
31
32
Functional test 33
16.
Safety check / metrological check 34
17.
Error messages / troubleshooting / disposal 35
18.
EMC declaration 37
19.
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.

1.1 Indications / Contraindications for Cryo 6 Physio 1

x Reduction of pain and stiffness and to support treatment of acute and chronic
Indications Cryo 6 Physio is designed for the following uses:
painful conditions of the musculoskeletal system

- Arthritis
- Bursitis
- Tendinitis
- Tenosynovitis
- Myositis
- Fibrositis
- Muscle tenseness
- Cervical syndrome
- Post-whiplash disorders
- Lumbar syndrome
x Pain reduction, improved mobility and reduction of joint stiffness in rheumatic

- Muscle or joint injuries
conditions
- Rheumatoid arthritis (progressive chronic arthritis)
x Reduction of spasticity in neurological disorders

- Post-synovectomy condition
- Multiple sclerosis
- Post-apoplectic hemiplegia
x to support movement therapy by prior cooling

other possible uses:
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
x to treat muscular trigger points in combination with stretching

immediately after major exertion, such as after a competitive event
Other indications must be discussed with the patient’s doctor or derived from
relevant specialist literature.
x
x
Absolute Cryoglobulinaemia
contraindications
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
Hypersensitivity to cold
Relative x When treating children, parts of the body that are not being treated must be
x When treating the face, the eyes must be covered.

contraindications covered and kept warm.
x Do not treat the face or trunk if the patient has severe arterial hypertension and
x The patient should not become excessively cold during treatment.

severe cardiac insufficiency.
Page 1

1.2 Indications / Contraindications for Cryo 6 Derma 1

Indications Cryo 6 Derma is designed for the following uses:
Reduction of pain and inflammation by cooling with cold air during and after
x Laser therapy
dermatological and cosmetic treatments
x Injections
x Photodynamic therapy
Advantages The analgesia associated with cold air makes the treatment much more pleasant for
the patient.
x less erythema
Reduction in the side effects that are often related to laser treatment:
x fewer swellings and encrustations

x reduction of pain and thermal skin damage
x
x
Absolute Cryoglobulinaemia
contraindications
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
Hypersensitivity to cold
Relative x When treating children, parts of the body that are not being treated must be
x When treating the face, the eyes must be covered.

contraindications covered and kept warm.
x Do not treat the face or trunk if the patient has severe arterial hypertension and
x The patient should not become excessively cold during treatment.

severe cardiac insufficiency.
Note: When using Cryo 6 with ablative lasers, make sure that the wound produced is given
appropriate antiseptic care after the treatment.
Page 2

Side effects
2
Side effects Cold-related skin damage such as skin reddening and even mild frostbite and
chilblains can occur, especially in sensitive patients.
Page 3

3.1 General 3
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.
After the device has been in transit on its side, place it upright and keep it in an
Caution ! upright position for at least 30 minutes before switching it on. Otherwise the
compressor will be damaged.
Before use, ensure that the device is powered via a properly grounded mains socket
Caution ! (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.
Magnetic and electrical fields can affect the function of the device. For this reason,
Caution ! 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.
Cryo 6 is not suitable for use in areas with an explosive, flammable or combustive
Caution ! atmosphere.
Do not place the device adjacent to heat sources (heating, hot mud products, sauna
Caution ! 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.
During use, the device is to be located in a position allowing direct access to the
Caution ! device´s central mains supply so that it can be disconnected from the mains at any
time.
To avoid the risk of electric shock, the plug must be disconnected from the power
Caution ! supply before performing any cleaning or maintenance activities.
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.
Caution !
Page 4

3.2 Cryotherapy 3
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.
x 1 cm distance for treatment times of up to 10 seconds,

Short distances between the skin and the nozzle are suitable for brief cooling:
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
x 10-15 cm distance for treatment times of approximately 15-30 minutes.

of larger areas of skin and static cooling of smaller areas:
Long distances between the skin and the nozzle are suitable for dynamic cooling of
x 15-20 cm distance for treatment times of over 30 minutes.

large areas of skin:
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).
Page 5

Warnings
4
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.
Page 6

Cryo 6 - in brief
5
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 It is very easy to use thanks to the pre-set program parameters and also very
of Cryo 6? powerful in prolonged use, matching the performance of much larger devices.
What are the other Its clear LCD display and ergonomic keyboard reflect the state of the art.
benefits of Therapy can be customised through six user-focused, pre-set programs as well as
Cryo 6? three programs with free choice of settings and an individual start-up program.
How is the necessary Air volume can be set to one of nine levels depending on the size of the area to be
concentration of cold treated and how accessible it is.
achieved? 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).
Page 7

Intended use
6
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.
Page 8

Device set-up
7.1 Fitting 7
Cryo 6 must be placed upright and kept in an upright position for at least 30 minutes
Caution ! 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.
All cables must be protected from pinching or other mechanical damage.

Caution !
Fitting the treatment Insert the treatment tube into the connector (5) on the front of the device and lock it
tube into place.
The treatment tube can be stored in the curved groove above the control panel (3)
when not in use.
Fitting the castor Attach the castor guards (2) to the wheel holders.
guards
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.
Page 9

Device set-up
7.1 Fitting 7
Glass plate
Clamp
bearing
Silicon disc
Spacing bolt
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.
Page 10

Device set-up
7.2 Fitting the supporting arm 7

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

supporting arm after
fitting
Guide through
glass plate and
anti-rotation
element
Supporting arm
pole
Supporting arm securing element
Page 11

Device set-up

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.
Guide sleeve
Part 1
Guide sleeve
Part 2
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.
Threaded
holes
The view from below is only presented for clarification, please DO NOT put the
Caution ! device down for fitting!
Page 12

Device set-up

Step 3 - attaching the anti-rotation element and pole
Place the anti-rotation element on the glass plate spacer as shown in the picture.
Anti-rotation
element
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.
Page 13

Device set-up

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.
- Recesses below
- Same bend orientation
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.
Page 14

Settings
8.1 Device menu 8

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.
Page 15

Settings
8.2 Device type and device configuration 8

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” sub-
menus 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.
Page 16

Settings
8.3 Default settings and service 8

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.
Page 17

Settings
8.4 Defrosting 8
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.
Page 18

Settings
8.5 Own programs and favourites 8

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 Use the arrows (14 and 15) to navigate among the three storage locations.
1-phase program 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 Here you can arrange for two programs with different fan levels and times to run
2-phase program 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.
Page 19

Settings
8.6 Information and maintenance programs 8

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.
Page 20

Operation instructions
9.1 Device description 9

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 pre-
cooling 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 We recommend that about 10 minutes should be left between the end of pre-cooling
optimum and the start of treatment. This ensures that the device has reached peak cold air
treatment 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.
Page 21

9.2 Performing cryotherapy 9

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 The device is ready to use as soon as the treatment screen (in this case “Physio”)
Program and treatment appears.
time
P2 7 10:00
OK Start/ Stop
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).
Page 22

9.3 Start-up screens 9

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
P2 7 10:00
OK Start/ Stop
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.
Page 23

9.4 Pre-set parameters / change 9

Cryo 6 Physio - pre-set
parameters Phase 1 Phase 2
Program Fan level Time Fan level Time
1 9 3 min - -
2 6 5 min - -
3 4 5 min - -
4 3 10 min - -
5 9 30 sec 6 2:30 min
6 7 1 min 5 4 min
Cryo 6 Derma - pre-set Program Fan level Time

parameters 1 7 45 min
2 5 45 min
3 3 45 min
4 8 15 min
5 6 15 min
6 4 15 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 Cryo 6 offers options to adjust the fan level and treatment time to individual
values 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.
Page 24

Technical information
10
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

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

Note: Storage and transport only in original packaging.
Evaporator temperature 115 V device 230 V device

generated minimum (standby) - 38°C - 43°C
maximum (standby) - 25°C - 25°C
Air output temperature average: - 25°C

(room temperature up to at the start of treatment: - 31°C
25°C) maximum: - 18°C (after 15 minutes of treatment)
Figures accurate to +/- 10%
Max. treatment time that 99:59 min

can be set
Maximum load on glass The maximum weight and size of devices (such as laser devices) that can be
plate placed on the glass plate is 35 kg and 50 x 50 x 35cm (W x D x H).
Subject to technical changes.
Page 25

Cleaning
Disinfection
11
- 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.
Page 26

CE mark / manufacturer
12
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 +49 731. 9761-299
www.zimmer.de
Page 27

Scope of delivery / accessories
13
Scope of delivery Version Cryo 6 Physio
Item no.
95850912 1 treatment tube Physio
1 nozzle 5mm
65370216 1 adapter for nozzles
1 nozzle 10mm
65370225
1 nozzle 15mm
65370224
65370223
66850122 1 glass plate with handles
4 plastic castors 75 mm
94851511 1 screw Set for glass shelf
80400756
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
4 plastic castors 75 mm
94851511 1 screw Set for glass shelf
80400756
67300124* 1 mains cable 230 V
65853112 1 accessory storage tray
10101665 1 instructions for use
Plastic castors 75 mm
Optional device castors

80400756
80401004
* Individual mains cable available. Please contact your distributor.
Page 28

Scope of delivery / accessories
13
Accessories For both device versions
Item no.
87413230 Blank plug for defrosted water container
65853112 Accessory storage tray

80400756
80401004
Version Cryo 6 Physio
Item no.
95850912 Treatment tube Physio
Nozzle 5mm
65370216 Adapter for nozzles
Nozzle 10mm
65370225
Nozzle 15mm
65370224
65370223
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.
Page 29

Device combinations
14
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.
Page 30

15.1 Safety 15
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.
Page 31

15.2 Maintenance 15
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 When Cryo 6 is switched off after use, or when the defrosting program is started, the
water container 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).
Page 32

Functional test
16
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.
Page 33

Safety checks
Metrological control
17
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.
Page 34

Error messages
Troubleshooting
Disposal 18
Mains fuse Cryo 6 is fitted with a bipolar overload protection element integrated into the main
is activated 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 Dirt in and around the defrost opening (8) may be the cause of a significant reduction
output / reduction in in cold air output and a weak air stream. Dust particles are deposited in the heat
cold air output 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.
Excess pressure cold circuit
OK Start/ Stop
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.
Page 35

Error messages
Troubleshooting
Disposal 18
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. +49 731. 9761- 291
Fax +49 731. 9761- 299
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.
Page 36

Manufacturer´s EMC declaration
19
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,
Harmonic emissions according to IEC Class A and in those which are connected directly to
61000-3-2 the public grid which also supplies buildings
used for residential purposes.
Voltage fluctuations/flickers according to not applicable
IEC 61000-3-3
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.
Page 37

19
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- Compliance Electromagnetic environment - Guidelines

test level level
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be made of wood or concrete or should be covered
discharge (ESD) discharge discharge with ceramic tiles. If the floor is covered with synthetic material,
according to IEC the relative air humidity must be at least
61000-4-2 ± 8 kV air ± 8 kV air 30%.
discharge discharge
Rapid transient ± 2 kV for ± 2 kV for power The quality of the supply voltage should correspond to that of a
electrical power cables cables typical business or hospital environment.
disturbances/bursts
according to IEC ± 1 kV for input ± 1 kV for input
61000-4-4 and output and output
cables cables
Surges ± 1 kV ± 1 kV The quality of the supply voltage should correspond to that of a

according to IEC differential differential mode typical business or hospital environment.
6100-4-5 mode
± 2 kV common
± 2 kV mode
common mode
Voltage dips, brief <5% UT <5% UT The quality of the supply should correspond to that of a typical
interruptions and (>95% dip in (>95% dip in the business or hospital environment. If the user of the Cryo 6
fluctuations in the the UT for ½ UT for ½ cycle) requires continued function even if interruptions in the power
supply voltage cycle) supply occur, it is recommended to power Cryo 6 from an
according to IEC 40% UT uninterruptible power supply or a battery.
61000-4-11. 40% UT (60% dip in the
(60% dip in the UT for 5 cycles)
UT for 5 cycles)
70% UT
70% UT (30% dip in the
(30% dip in the UT for 25 cycles)
UT for 25
cycles) <5% UT
(>95% dip in the
<5% UT UT for 5
(>95% dip in seconds)
the UT for 5
seconds)
Magnetic field at 3 A/m 3 A/m Magnetic fields at the mains frequency should correspond to the
power supply typical values found in a business or hospital environment.
frequency (50/60
Hz) according to
IEC 61000-4-8
Note: UT is the a.c. supply voltage prior to application of the test level.
Page 38

19
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 IEC 60601- test Compliance level Electromagnetic environment - Guidelines

tests level
Conducted 3 VEffective value 3 VEffective value Portable and mobile radio equipment should not be used
HF 150 KHz to 80 MHz 150 KHz to 80 MHz at a distance away from the Cryo 6, including the cables,
disturbances that is less than the recommended safety distance which is
according to calculated according to the equation applicable to the
IEC 61000- 3 V/m transmission frequency.
4-6 80 MHz to 2.5 GHz 3 V/m
80 MHz to 2.5 GHz Recommended safety distance:
Radiated HF
disturbances G ¥3
according to
IEC 61000- G ¥3IRU0+]WR0+]
4-3
G ¥3IRU0+]WR GHz
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 levelb
according to on-site testinga
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.
Page 39

19
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 Safety distance depending on the transmission frequency
W m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
G ¥3 G ¥3 G ¥3
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.
Page 40

Cryo 6
Instructions for Use
EN 10 101 665 UR 1216 I Version 4 I Right of modification reserved
Zimmer MedizinSysteme GmbH

Junkersstrasse 9
D-89231 Neu-Ulm
Tel. +49 731. 97 61-291
Fax +49 731. 97 61-299
[email protected]
www.zimmer.de

Instructions For Use: Cryo 6

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Front of the device

Device and 1 Castors

Downloaded from www.Manualslib.com manuals search engine

Rear of the device

Device and 9 Air filter

Downloaded from www.Manualslib.com manuals search engine

Screens and display

Display views 19 Program view

Downloaded from www.Manualslib.com manuals search engine

In the instructions for use this symbol indicates “Danger”.

Applied part type B

do not push sideways

max. permitted load on glass plate 35 kg

Follow instructions for use.