Zimmer Cryo 6 User manual

Instructions for Use
Cryo 6
USA

Illustrations
Front of the Device
Fig. 1
Devices and
operating
elements
1 Castor
2 Castor guards
3 Control panel
4 Tray
5 Treatment tube connector
6 Treatment tube
7 Container for defrosted water
8 Defrost drain
1
2
4
5
6
8
3
7

Illustrations
Rear of the Device
Fig. 2
Devices and
operating
elements
9 Air filter
10
Mains switch
11 Power inlet
12 Identification plate
9
10
11
12

Illustrations
Screens and Displays
Fig. 3
OK Start/ Stop
10:00
P2 7
P P
Operating
element display 13 OK key 14 Arrow key for navigation / changing parameters
15 Arrow key for navigation / changing parameters
16 Arrow key for navigation / changing parameters
17 Arrow key for navigation / changing parameters
18 Start/Stop button
Fig. 4
OK Start/ Stop
10:00
P2 7
P P
Displays 19 Program display
20 Graphic air power level display
21 Numeric air power level display
22 Graphic therapy time display
23 Numeric therapy time display
14 15
13
16
17
18
19 20 21
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
Maximum permissible load on the glass plate 35kg
Follow instructions for use
Operation instructions
Serial number
Article number
Manufacturer
Date of manufacture
Max 35kg/
77.16lb

Contents
Illustrations
Front of the Device
Rear of the Device
Screens / Displays
Explanation of Symbols
Page
1.
Indications / Contraindications 1
2.
Application Information
2.1 General
2.2 Cryotherapy
2
3
3.
Warnings 4
4.
Cryo 6 - in brief 6
5.
Intended Use 7
6.
Device Set Up
6.1 Assembly
6.2 Assembling the Supporting Arm
8
10
7.
Settings
7.1 Configuration Menu
7.2 Device Type and Device Configuration
7.3 Basic Settings and Service
7.4 Defrosting
7.5 Own Programs and Favorites
7.6 Info and Maintenance Programs
14
15
16
17
18
19
8.
Operating Instructions
8.1 Cold Treatment
8.2 Start Screens
8.3 Default Parameters / Modification
20
21
22
24
9.
Technical Information 24

Contents
10.
Cleaning / Disinfection 25
11.
UL - Classification 26
12.
Scope of Delivery and Accessories 27
13.
Device Combinations 28
14.
Safety and Maintenance
14.1 Safety
14.2 Maintenance
29
30
15.
Functional Test 31
16.
Error Messages / Troubleshooting / Disposal 32
17.
Manufacturer´s EMC declaration 34
Valid for Cryo6 devices.
This instructions for use is an integral part of the device. It must be stored with the device and kept accessible at all
times for anyone authorized to operate this device.
Full observation of these instructions is a requirement for the correct application an operation of the equipment and for
the consequent safety of both patient and operator.
The instructions for use is valid as of February 2015.

Indications / Contraindications
1
Seite 1
Indications Cryo 6 cold air device is intended to minimize pain and thermal injury during laser
and dermatological treatments and for the temporary topical anesthetic relief for
injections.
Contraindications

hypersensitivity to cold
areas of impaired sensation
areas of impaired circulation
open wounds
ablative laser treatment
frostbites
Raynaud disease
cryo-globulinema
cold agglutinin disease

Application Information
2.1 General 2
Seite 2
Before the device is used on a patient, the user should become acquainted with the
operating instructions and individual treatment methods as well as the indications /
contraindications, warnings and application information. Additional sources of
information about types of therapy should be consulted.
Prior to treatment, patients should be informed of the goals and effects of cold air
therapy with Cryo 6.
Clearly advice the patient that the therapist must be immediately informed if
discomfort, such as an extreme sense of heat or cold, occurs during the treatment.
The operator should continue to inquire into the patient´s comfort during the
treatment. If necessary, the treatment parameters (air power level and distance to
the treatment area) should be adjusted.
The airflow level and the distance between the treatment tube’s handpiece and the
treated area should be selected to maximize patient’s comfort. During the treatment
the patient has to be asked about his sensations. If necessary the treatment
parameters (airflow and therapy distance) should be modified.
For temporary topical anesthetic relief for injections, the treated area should be
cooled to a comfortable level for the patient. Prior to the injection, the treated area
must be disinfected to avoid contamination.
When using the device in conjunction with a laser device, a distance of 5 cm for a
treatment surface of 10 cm² is recommended. When treating larger areas, the
distance should be increased accordingly. Longer treatments are required to achieve
sufficient cooling.
Please be aware that the temperature of the air current can increase after longer
treatments.

Application Information
2.2 Cryotherapy 3
Seite 3
To treat larger areas, the distance from the nozzle to the skin should be increased,
resulting in longer treatment times for adequate cooling.
At a distance of 5cm, the cooling spot covers app. 10cm2.
Hygienic gloves should be worn during the treatment.
Before treatment, the purpose and effect of cryotherapy using Cryo 6 should be
explained to the patient.
Advise the patient to report any adverse reactions during treatment (e.g. extreme
cold sensations) immediately to the practitioner.
Throughout the treatment, the practitioner should check the wellbeing of the patient
by asking appropriate questions.
If necessary, adjust the treatment parameters (air flow rate, distance from treatment
area).
For use in conjunction with laser equipment, a distance of 2 inches (5cm) is
recommended for a treatment area of 4 square inches (10cm²). Larger areas should
be treated using a correspondingly larger distance. In such cases, a longer treatment
time is necessary to achieve the required cooling

Warnings
3
Seite 4
Caution!
The device may only be used by trained medical personal
Caution! After horizontal transport, let the device stand upright for at least 30 minutes prior to
switching it on. The cooling aggregate might become damaged otherwise!
Caution!
Do not install the device in the immediate vicinity of heat sources (heaters, hot mud
heaters, saunas, etc.) and make sure it is at least 50 cm from the wall.
When simultaneously using a laser device, the laser exhaust system must not
negatively impact the Cryo 6 cooling system.
Caution!
Unfavorable ambient conditions (e.g. ambient temperature above 86 F / 30°C and
high humidity) may lead to a reduction in performance (reduced cooling capacity).
Caution!
Before use, ensure that the device is powered via a properly earthed plug with a
grounded outlet (electrical installation according to DIN VDE 0100 Part 710). The
device must only be operated with the supplied power cord. The power cord must be
protected against mechanical stress.
Caution!
When in operation, the device must be positioned in such way that direct access to
the power supply of the device is possible, so that it can be disconnected from the
mains at any time.
Caution!
Inspect the device prior to use. In case of damage, it must not be used.
Caution!
Only accessories provided by Zimmer MedizinSysteme GmbH are to be used.
Magnetic and electric fields may affect the operation of the unit. Do not use Cryo 6
close to equipment that generates strong electromagnetic fields (e.g. X-ray or
diathermy equipment or nuclear magnetic resonance tomography devices)
Dispose of the packaging material properly. Make sure that it is not accessible to
children.
Cryo 6 is not suitable for use in areas with an explosive, flammable or combustive
environment.
User of the device must be trained in how to use the device properly and have the
appropriate skills
To avoid contamination with non-filtered air on open wounds, the Cryo 6 must not be
used during or after injection.
To avoid freezer burns and over-cooling, the air stream should be directed evenly
over the entire area to be treated. Static cooling, or overly intensive cooling, should
be avoided.

Warnings
3
Seite 5
Do not increase laser output power or energy when using Cryo6 for skin cooling.
Skin cooling may reduce effectiveness of some laser treatment on identical power
output of the laser.
To avoid the risk of electric shock; the device must be disconnected from the mains
by unplugging the power cord before performing any maintenance or cleaning
activities.
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 authorized physicians, therapists
and health paraprofessionals. It is imperative that these instructions are followed.
The use in wet areas is not permitted and may in case of non-compliance lead to
considerable damage to the device and endanger both the patient and the user.
Eyes must be protected during cooling applications on the face.
Operating the device with settings/for uses other than those in the operating
instructions can lead to risks due to uncontrolled effects of cold.
Children are at risk of extreme cooling. The body parts not undergoing treatment
must be covered and kept warm. This is also recommended for adults undergoing
long-term cooling.
If the temperature of the skin drops to 0° C or below, frostbite may occur. This can
be happen if the distance from the nozzle to the skin is under 10 cm. If this distance
cannot be maintained for therapeutic reasons, dynamically guiding the nozzle across
the treatment area is recommended.
Do not push the device on the sides marked with warning symbols.
Do not lean against the device.

Cryo 6 - in brief
4
Seite 6
What is the Cryo 6? Cryo 6 is used for skin cooling in conjunction with dermatological laser treatments
for alleviating pain and thermal damage to skin tissue.
What does the Cryo 6
do? Cryogenic air is blown onto the area of the body to be treated using an adjustable flow speed.
What are the
advantages of
Cryo 6?
Its user-friendliness due to preset program parameters in conjunction with a
capacity in continuous mode that is usually only achievable with significantly larger
devices.
What are other
advantages of
Cryo 6?
The clearly structured LCD display and the ergonomic keyboard stand for state-of-
the-art technology.
In addition to 6 user-oriented preset programs, 3 free programs and an internal start
program enable customized treatment.
How is the necessary
cooling concentration
achieved?
Depending on the surface and accessibility of the treatment area, the amount of air
can be adjusted to nine levels.
Notice: The device is intended to be used exclusively by medical professionals
(e.g. physicians, therapists, medical paraprofessionals).
Caution:
Federal law restricts the device to sale by or on the order of a physician.

Intended Use
5
Seite 7
Cryo 6 cold air device is intended to minimize pain and thermal injury during laser
and dermatological treatments and for the temporary topical anesthetic relief for
injections.

Device Set Up
6.1 Assembly 6
Seite 8
Caution!After horizontal transport or assembly, the Cryo 6 must stand upright for at least 30
minutes prior to being switched on.
The compressor might otherwise be damaged.
Connect the power
cord Connect the power cord to the socket (11) on the device and connect it to the mains.
Notice: The device may only be connected to outlets with a protective contact.
Switch on the device The device is switched on using the toggle switch (10).
Switch off the device The device is switched off using the toggle switch (10).
To completely disconnect the device from the mains (all poles), unplug the power
cable.
Caution!
All cables must be protected against getting clamped or other mechanical damage.
Assemble the
treatment tube The treatment tube is inserted and locked into the connection piece (5) on the front of the device.
When not in use, the treatment tubes can be placed in the curved indent above the
operating panel (3).
Assemble the castor
guards
The castor guards (2) are inserted into the castor holders.
Assemble the glass
plate Four spacer bolts are already installed on the top of the device for installing the glass
plate.
Place a silicon washer on each of the four spacer bolts.
Then place the glass plate on the spacer bolts.
Anchor the glass plate by screwing one of the provided clamp bearings into each of
the 4 spacer bolts.
In order to not damage the glass plate, no tools are necessary.
Tighten the clamp bearings by hand.

Device Set Up
6.1 Assembly 6
Seite 9
To remove the glass plate, reverse these steps.
Do not lift the device by the glass plate.
Notice: The nozzles for the cold air discharge are attached to the therapy nozzle at the end
of the tube.
The therapy nozzle and nozzle inserts can be stored in the toolbox.
Glass plate
Clamp
bearings
Silicon washer
S
p
acer bolts

Device Set Up
6.2 Assembling the Supporting Arm
6
Seite 10
Supporting arm The Cryo 6 device can be optionally equipped with a supporting arm.
This arm allows a specific area of the body to be cooled without
the therapist having to hold the tube.
The supporting arm accessory set consists of:
1 supporting arm bracket
2 M6x16 screws and Allen wrench for tightening
1 torsion protection
1 supporting arm rod
1 rotating supporting arm
1 tube clip
1 tube bracket
in addition, the following are required
glass plate
insertion duct
Picture of the
assembled support
arm
Rotatin
g
support arm
Rotating supporting arm
Supportin
g
arm rod
Supportin
g
arm bracket
Feed through of
glass plate and
torsion protection

Device Set Up
6.2 Assembling the Supporting Arm
6
Seite 11
Assembly In order to be able to assemble a support arm, the glass plate must be attached to
the device (see 7.1 Assembly). The glass plate has an opening through which the
support arm is guided.
Notice: The glass plate can be assembled symmetrically with the device. If a support arm is
also installed, the glass plate is placed on the spacer bolts so the hole for positioning
the support arm is on the desired side of the device.
Step 1 - Assemble the insertion duct
The insertion duct (included with the glass plate) is assembled in the provided hole.
Step 2 - Assemble the support arm bracket
The mounting bracket is screwed to the bottom of the device using an Allen wrench
and the M6x16 screws.
There are already threaded holes on the bottom of the device.
Caution !The illustration of the bottom of the device is only for a better view. Please do
NOT lay the device down this way for assembly!
Grommet
Part 1
Grommet
Part 2
Thread

Device Set Up
6.2 Assembling the Supporting Arm
6
Seite 12
Step 3 – Attach the torsion protection and rod
The torsion protection is attached to the glass plate spacers as illustrated.
Then, the supporting arm rod is inserted from above through the insertion duct and
torsion protection and locked into the supporting arm bracket.
Anti-rotation

Device Set Up
6.2 Assembling the Supporting Arm
6
Seite 13
Step 4 – Attach the supporting arm
The supporting arm is screwed to the assembled rod (a). To ensure that the
supporting arm can move freely up / down, the notches must be adjusted. They must
lie on an axis and allow the rod to move in the direction of the bend.
Step 5 – Attach the tube clip / tube bracket
The tube clip is screwed to the supporting arm (b); the tube bracket is hung on the
fixation screw on the supporting arm (c).
The treatment tube can now be guided over the tube bracket and the hand piece
locked into the tube clip.
-Recesses below
-Same bending direction