Zimmer Cryo 7 User manual

Instructions for Use
Cryo 7
EN

Figures
Front of the device /
Detailed description –defrost container
Fig. 1
1
Cryo 7
2
Display
3
Shelf plate
4
Ventilation slits
5
Maintenance door of the defrost container
Fig. 2 Detailed description –defrost container
6
Button to open the maintenance door of the defrost container
7
Maintenance door of defrost container opened
8
Defrost container
3
1
2
4
6
7
8
5

Figures
Rear of the device
Fig. 3
9
RS232 connection port for data communication with medical technology devices
10
Connection port for USB
11
Handle
12
Air filter
13
Ventilation slits
14
Base
15
Castors with locking device
16
Locking lever
17
Connection for power cable
18
Mains switch
19
Air outlet with magnetic connection and treatment tube connection
20
Connection port for spring arm
18
17
19
20
16
9
10
12
14
15
13
11

Figures
Rear of the device / Detailed description
Fig. 4 Detailed description Air outlet with magnetic connection /
Connection port for spring arm / Locking lever
21
22
23
Air outlet with magnetic connection and treatment tube connection
Connection port for spring arm
Locking lever
“The angle of the lever can be adjusted by pulling the locking lever and
simultaneously twisting the device connection. Releasing and subsequently
juggling the device connection allows the lever to click into the next possible
position and the device connection is once again locked in place.”
21
22
23

Figures
Accessories
Fig. 5 Accessories
24
Cryo 7 Therapy Hose 2.5m
25
Cryo 7 Therapy Hose Spring Arm
26
Cryo 7 Air Filter

Screens / Display
Fig. 6
Display views 27 Status bar
28 Buttons on the screen
29 Buttons in the navigation menu
30 Buttons / displays in the status bar
31 Fill level of defrost container; when defrost container is full, the icon switches to
“Empty defrost container” (see Fig. 7 (I))
Fig. 7
Navigation bar/ (A) Switches to the general information area
Status bar (B) Switches to the Memory area to save Favourites
Function description (C) Switches to the Configuration area
(D) Starts the defrosting process
(E) Status of the UV module (if this is available)
(F) Indication of dirt on air filter (only active in the case of dirt on the filter or if a
filter change is needed –in this case, “Change needed” icon)
(G) Switches to the Favourites area
(H) Switches to the therapy screen
(I) Empty defrost container
27
30
29
28
A
B
C
D
E
F
G
H
I
31

Explanation of symbols
No.
Symbol
Description
1
The CE mark symbolises the conformity of the product with the applicable
requirements which the European Community imposes on the manufacturer.
2
Medical device
3
This symbol indicates “Danger” with regard to possible risks to people.
4
This symbol indicates “Caution” with regard to possible material damage.
5
Follow instructions for use.
6
Instructions for use
7
Serial number
8
Article number
9
Manufacturer
10
Date of manufacture
11
RS232 interface
12
USB interface
13
Do not push
14
Maximum load of the shelf plate (35 kg)
15
Off (power supply)

Explanation of symbols
No.
Symbol
Description
16
On (power supply)
17
Disposal of electrical and electronic devices as well as used disposable and
rechargeable batteries. Products which are marked with the adjacent symbol may not
be discarded with household waste.
18
Do not stack
19
Protect from moisture
20
Transport upright
21
Fragile
22
Temperature limits
23
Moisture limits
24
Air pressure limits
25
The UDI “Unique Device Identifier” is assigned for unique device identification and
traceability.

Contents
Figures
Front of the device / Detailed description –defrost container
Rear of the device
Rear of the device / Detailed description
Accessories
Screens / Display
Explanation of symbols
Page
1
Intended use
1.1 Indications / Contraindications
1.2 Side effects / Residual risks
1
2
2
Application information and warnings
3
3
Cryo 7 performance features
6
4
System set-up
7
5
Software
10
6
Operation instructions
6.1 Configuration
6.2 Performing the treatment
6.3 Displays and buttons –start screen
11
13
14
7
Technical information
16
8
Cleaning / Disinfection
17
9
CE mark
18
10
Scope of delivery and accessories
19
11
Device combinations
20

Contents
12
Safety / Maintenance / Service
12.1 Safety
12.2 Service
21
22
13
Functional test
26
14
Legal notice
27
15
Function failure / Error message / Troubleshooting / Disposal
28
16
Manufacturer’s EMC declaration
30
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 December 2021.
If the instructions for use have become illegible, damaged, or are not accessible for the user for other reasons,
a replacement is to be requested from the manufacturer for the safe use of Cryo 7 and made available to the
user. This also includes the information on the labels on the device.
The instructions for use can also be downloaded from our website.
We reserve the right to revise this document at any time or change product specifications described. There is
no obligation to provide information about the changes to the customer.

Intended use
1.1 Indications / Contraindications
1
Page 1
Indications
•Acute and chronic painful conditions of the musculoskeletal system
▪Rheumatic diseases
▪Tendinopathies
▪Acute inflammation
▪Pain in the lower back
•Procedure-related pain
▪Knee, hip, spinal and shoulder surgery
•Periprocedural pain
▪In dermatology such as photodynamics and laser therapy
▪For chest drain removal
▪Before/during injections and aspirations
•Spasticity and pain in connection with neurological disorders
Contraindications
•Systematic lupus erythematosus
•Vasculitis
•Cryoglobulinaemia
•Cold hypersensitivity
•Allergies or urticaria
•Cold-induced bronchospasm
•Raynaud’s disease
•Acrocynosis
•Sickle cell anaemia
•Skin circulation disorders
•Areas with sensory disturbances
•Paroxysmal cold haemoglobinuria
•Heart arrhythmia
•Symptomatic cardiovascular or lung diseases
•Uncontrolled hypertension
•Advanced diabetes mellitus
•Trophic disorders such as cutaneous hypoesthesia
•Scleroderma
•Spinal cord injury
•Cold urticaria
•Cold agglutinin disease and cold haemolysis

Intended use
1.2 Side effects / Residual risks
1
Page 2
Side effects
Temporary cold-related skin damage can occur, especially in sensitive patients.
Intended purpose
Cold air therapy devices are intended to cool the surface of the patient’s skin
locally and contactlessly. The area of application encompasses physical
therapy in pain and inflammatory processes of the musculoskeletal system as
well as aesthetic medicine as a supportive cooling procedure in combination
with cosmetic treatments such as laser therapy or injections for pain reduction.
Target patient group
Age
Age 3 years and over
Sex
No limitations
Potential patient
group
The patients must be able to perceive pain and communicate.
Patients who have at least one of the contraindications listed
may not be treated.
Weight
No limitations
User
Cold air therapy devices are intended exclusively for medical professionals, such
as authorised physicians, therapists, and medical paraprofessionals. Cold air
therapy devices are not intended for use by laypersons or in home care.
State of health: The user may not have any visual, hearing or colour vision
impairment which interferes with safe device operation and use.
Residual risks:
If the device is used within its intended purpose, no other unacceptable
residual risks are known besides the side effects and the warnings already
mentioned.
Anticipated clinical
efficiency:
Pain reduction through pain-relieving cold air therapy.

Application information and warnings
2
Page 3
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.
Children’s body parts which are not being treated should be covered and kept
warm. This is also recommended for adults who are undergoing longer cooling.
Treatment instructions concerning the place of treatment, location and extent of
treatment require medical knowledge and may only be given by licensed
physicians, therapists and health professionals. These instructions are
mandatory.
During skin cooling with the cold air therapy device in combination with laser
applications, the laser power must not be increased beyond the level
recommended by the manufacturer.
Frostbite can occur if the skin temperature falls to 0°C or below. This can
happen if the nozzle is less than 10 cm from the skin. If it is not possible for
therapeutic reasons to maintain this distance, it is recommended to move the
nozzle dynamically over the area to be treated. Do not use the air outlet in
direct contact with patient skin.
The patient must not be left unattended during the therapy. The user must take
note of the patient’s feedback and react accordingly.
The user must ventilate the treatment room at the beginning and at the end of a
working day. We recommend blowing out the therapy hose 3 minutes before
the treatment at fan speed 3 and not directly to the treatment area.
The cold air therapy device shall not be used in hygienically critical medical
areas such as operating rooms, intensive care units, infection areas or
emergency departments.
Use in wet areas is not permissible and, in case of non-compliance, may lead
to considerable damage and endanger both the patient and the user.
If the cold air stream meets open wounds or comes into contact with skin
compromised by the therapy, disinfection and, if necessary, further treatment of
the wounds (plaster, wound dressing, etc.) must be carried out in any case after
completion of the treatment.
Dispose of the packaging material properly. Ensure that it is stored out of the
reach of children.
When applying cold to the face, it is essential to protect the eyes and mucous
membranes in general.

Application information and warnings
2
Page 4
If the operator identifies a potential safety issue or operating abnormality during
use, the operator should stop the treatment immediately and contact the
manufacturer .
To avoid the risk of electric shock, the mains plug must be disconnected from
the power supply before performing cleaning or maintenance work.
Check Cryo 7 before use. If it has any damage, the device should not be used
and the customer service needs to be contacted.
Do not place the device in the vicinity of heat sources (heater, hot medicinal
mud products, sauna, etc.) and leave a distance of at least 50 cm between the
device and a wall (to enable the supply of cool air).
If used in combination with a laser device, the laser ventilation system should
not interfere the cooling of the cold air therapy device.
Do not switch Cryo 7 on and immediately off. Doing so could damage Cryo 7.
To transport over thresholds, Cryo 7 must be moved over a threshold
backwards by lifting it at the handle.
After transport or storage on its side, Cryo 7 must be brought to an upright
position and kept in an upright position for at least 30 minutes before it is
switched on. Otherwise the compressor will be damaged.
Before use, ensure that Cryo 7 is supplied with power via a properly grounded
power outlet (electrical installation according to DIN VDE 0100 part 710). Cryo
7 may only be operated with the supplied power cable. The power cable must
be protected against mechanical stress.
Magnetic and electrical fields can impair the function of the device. For this
reason, do not operate Cryo 7 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 7 is not suitable for use in areas with an explosive, flammable or
combustive atmosphere. The Cryo7 is intended to be used in closed and dust-
free treatment and examination rooms,
During use, Cryo 7 should be set up such that direct access to the central
mains power supply of the device is possible so that it can be disconnected
from the mains at any time.

Application information and warnings
2
Page 5
Only accessories provided by Zimmer MedizinSysteme GmbH may be used.
If the UV module (if applicable) is defective, the service has to be contacted.
Objects must be placed in the centre of the shelf plate. Observe the maximum
load! Do not place any liquids on the shelf plate.
Pushing Cryo 7 at the sides labelled with corresponding warnings is not
permitted. Do not lean on the device.
The treatment room should be ventilated in the morning and evening.
Only USB sticks may be inserted in the USB port. It is prohibited to draw
operating voltage for small devices or connect devices with an external power
supply.

Cryo 7 performance features
3
Page 6
What is new?
The use of the latest technology to provide cold air.
Space-saving thanks to a slim housing type in a new design.
Ergonomic operation.
High-resolution display with touch operation.
All keys, menus and sub-menus, as well as buttons can be activated
directly on the touch screen with finger pressure.
Modern swipe and drag function on the touch screen to select your user
preferences with regard to fan level and therapy time.
The new, flexible spring arm assists and supports the user during therapy.
Energy-saving mode through standby operation.

System set-up
4
Page 7
Important notes
After transport/assembly or repair, Cryo 7 must be placed in and kept in an
upright position for at least 30 minutes before being switched on. If Cryo 7 is
switched on before the 30 minutes have elapsed, the compressor can
become damaged.
The mains plug may be inserted only in a power outlet with a protective
contact.
Removal from the
packaging
Cryo 7 can be removed from the packaging by the user on site.
Cryo 7 is delivered in a box on a wooden pallet.
The device and accessories are housed in the box.
Open the box by lifting the lid.
To facilitate removing the device from the packaging, you can fold the lid of
the box into a ramp.
You can roll Cryo 7 off the pallet using the ramp.
Converting the lid
into a ramp
Follow the conversion instructions enclosed with the box or follow the
conversion instructions in our YouTube video. To do this, scan the QR code
(on the side of the lid of the Cryo 7 box) using your smartphone.
Remove the accessories box at the rear of Cryo 7.
Remove the white plastic protective inlay.
Lift the box upwards off the pallet.
Ensure that there is adequate space above the pallet and that there is
nothing above the box which could be damaged.
Remove accessories box 2.
Attach the ramp (converted lid) to the pallet.
Release the brakes on the castors of Cryo 7. Roll the device out slowly and
carefully.
It is important to support the device.
Risk of tipping!
Reassemble the box, following the steps in reverse order.
Keep the box.

System set-up
4
Page 8
Set-up
There is a handle (11) on the back of Cryo 7.
You can use this handle to push Cryo 7 and move it to its destination.
Assembly of the
treatment tube
Mount the treatment tube with the magnetic components at the air outlet
(note the orientation relative to the indentation) at the rear of the device (19).
The treatment tube is secured using the magnetic components on the air
outlet.
Assembly of the
spring arm
Insert the spring arm in the intended hole which is located at the top of the air
outlet (20).
The spring arm holds the treatment tube and assists the user by supporting
the weight of the treatment tube.
Assembly of the tube
in the spring arm
Place the treatment tube in the guide of the spring arm
Dismantling the
treatment tube
Remove the treatment tube from the guide of the spring arm.
Remove the spring arm from the air outlet. Hold the treatment tube on the
device end at the plastic sleeve. Tilt the tube towards the left or right by
pressing firmly with your thumbs and pull it out at an oblique angle.
Due to the strength of the magnets, a certain amount of resistance must be
overcome.
All application parts which can come into contact with the patient must be
cleaned before initial use and before the first patient contact in order to
remove residues from production and packaging. No part of the device may
be in the immediate vicinity of the patient since this is a contactless
application.
AC mains
connection
Guide the power cable under the handle.
Connect the power cable to the provided port on the device (17) and connect
the cable to the mains.

System set-up
4
Page 9
Start-up
Switch on the device using the power switch (18).
After it is switched on, Cryo 7 performs a one-time initial set-up.
You are guided through a brief menu with the following questions:
1. Language selection
2. Temperature display selection
3. Colour configuration
a. PT colour = blue
b. Derma colour = orange
If you would like to make an entry, activate the desired button.
If you would like to enter distributor information
1. Distributor name,
2. Distributor telephone
3. Distributor email
activate the desired button and enter the information using the keypad.
Activating the “Continue” button leads to the next screen page and activating
the “Back” button leads to the previous screen page.
The “Continue” button jumps to the next screen page.
Swiping left or right on the screen is also possible and leads to the previous
or next screen page.
The data in the initial set-up are accepted by activating the “Save” button.
Thereafter Cryo 7 switches to the “Precooling” cooling phase. The cooling
phase is represented by an active bar display.
As long as the cooling phase is running and the bar display is active, no
button entries can be made. If the cooling phase has completed, the bar
display ends and Cryo 7 switches directly to the therapy screen.

Software
5
Page 10
IT safety measures
and information
Cryo 7 is controlled via special device software.
The Cryo 7 device software is protected by special software protection
measures against copying.
Only USB sticks may be inserted in the USB port. It is prohibited to draw
operating voltage for small devices or connect devices with an external
power supply.
The version number of the software can be found in the service screen for
users in “software versions”.
Cryo 7 has 2 interfaces: an RS232 interface for possible device
communication and a USB interface.
The USB interface is used for writing log files or for possible updates to Cryo
7.
The RS232 interface may be used only by technical personnel. The
manufacturer of the connected device is responsible for this device
combination (see chapter 11).