Enraf-Nonius CryoOne User manual

Brand: Enraf-Nonius

Model: CryoOne

Category: Skin care appliances

Type: User manual

CryoOne

EN109-3442254-40

0123

Instructions for use

Page 2 of 40 EN109-3442254-40

Illustrations

Front, Side and Rear of the Device

Fig. 1

Fig. 2

Device and

operating

elements

Treatment tube connector

LC display

Star base with fixable castors

Defrosted water container

Mains power connector

Air filter

RS 232 interface (accessible only by service technician)

Mains switch

Page 3 of 40 EN109-3442254-40

User interface

Device and

operating

elements

Fan Speed setting

Therapy clock

Therapy start button

Therapy time display

Fan Speed Level display

Water level indicator

Configuration/service menu

Page 4 of 40 EN109-3442254-40

Explanation of symbols

This symbol indicates “Danger” with regard to possible risks to people.

This symbol indicates “Caution” with regard to possible material damage.

Applied part type B

Follow instructions for use.

Serial number

Article number

Manufacturer

Date of manufacture

This symbol indicates the bidirectional RS 232 interface.

Medical device

Weight

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.

The CE mark symbolises the conformity of the product with the applicable

requirements which the European Community imposes on the manufacturer.

Page 5 of 40 EN109-3442254-40

Consult instructions for use

Protective earth

Warning electricity sign

Unique Device Identification

IPXO

IP protection class

Page 6 of 40 EN109-3442254-40

Contents

Illustrations ................................................................................................................................................................. 2

Front, Side and Rear of the Device ................................................................................................................................... 2

User interface ............................................................................................................................................................................ 3

Explanation of symbols ......................................................................................................................................................... 4

1 Indications / Contraindications .................................................................................................................. 7

1.1 Indications ........................................................................................................................................................................... 7

1.2 Contraindications ............................................................................................................................................................. 8

1.3 Treatment information ................................................................................................................................................... 9

2 Side effects / Residual risks ...................................................................................................................... 10

3 Application information............................................................................................................................. 11

3.1 General ............................................................................................................................................................................... 11

3.2 Cryo therapy ..................................................................................................................................................................... 12

4 Warnings ......................................................................................................................................................... 14

5 CryoOne – in brief ........................................................................................................................................ 16

6 Intended Use ................................................................................................................................................. 17

7 Device set-up ................................................................................................................................................. 18

8 Operation instructions / Device settings............................................................................................. 19

8.1 Switch on and off ........................................................................................................................................................... 19

8.2 Startup Display ................................................................................................................................................................ 20

8.3 Therapy Screen ............................................................................................................................................................... 21

8.4 Configuration / Service Menu ................................................................................................................................... 22

9 Technical information ................................................................................................................................. 24

10 Cleaning and Disinfection ......................................................................................................................... 25

11 CE-Mark / Manufacturer............................................................................................................................ 27

12 Scope of delivery and accessories ......................................................................................................... 28

13 Device combinations .................................................................................................................................. 29

14 Safety and maintenance ............................................................................................................................ 30

14.1 Safety ................................................................................................................................................................................ 30

14.2 Maintenance .................................................................................................................................................................. 31

15 Functional test ............................................................................................................................................... 32

16 Legal information ......................................................................................................................................... 33

17 Error message, troubleshooting, disposal .......................................................................................... 34

18 Manufacturer’s EMC declaration ............................................................................................................ 35

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 June 2023 for the product CryoOne.

Page 7 of 40 EN109-3442254-40

1 Indications / Contraindications

1.1 Indications

Indications in

physical therapy

Reduction of pain and stiffness and as a supplemental treatment for acute

and chronic painful diseases of the musculoskeletal system:

• Arthritis

• Bursitis

• Tendinitis

• Tenosynovitis

• Myositis

• Fibrositis

• Muscle Tension

• Cervical Syndrome

• Post-whiplash disorders

• Lumbar Syndrome

• Muscle or Joint injuries

Pain reduction, improvement of mobility and reduction of joint stiffness

for rheumatic diseases

• Rheumatoid arthritis (progressive chronic arthritis)

• Post-synovectomy conditions

Reduction of spasm for neurological disorders

• Multiple sclerosis

• Post-apoplectic hemiplegia

Other possible uses:

• Support for movement therapy using preceding cooling

• In combination with compresses for acute injuries

• For preventing oedemas and hematomas

• In the field of sports medicine for preventative early treatment prior

pain setting in, immediately after severe stress, e.g. competitions

• For treating muscular trigger point in combination with stretching

Indications in

dermatology

Pain and inflammation reduction by cooling using cold air and after the

application of dermatological and cosmetic treatments:

• Laser therapy

• Injections

• Photodynamic therapy

Advantages

The analgesia associated with cold air makes the treatment much more

pleasant for the patient.

Reduction of the side effects frequently connected to laser applications:

• Less Erythema

• Less swelling and encrustations

• Reduction of pain and thermal skin damage

Page 8 of 40 EN109-3442254-40

1.2 Contraindications

Absolute Contra-

indications

• Cryoglobulinaemia

• Cold agglutinin diseases and haemolysis

• Cold urticaria

• Parts of the body with impaired circulation

• Raynaud’s syndrome

• Parts of the body with impaired sensitivity

• Trophic disorders

• Hypersensitivity to cold

• Region around the eye

• Pregnancy

• Open wounds

• Damage or wounded skin

• Active implants

• Treatment in mucous membrane

Relative Contra-

indications

• Treatment of children younger than 6 years

• Arterial hypertension und cardiac insufficiency.

Note :

When using CryoOne with ablative lasers, make sure that the wound

produced is given appropriate antiseptic care after the treatment.

Page 9 of 40 EN109-3442254-40

1.3 Treatment information

Treatment

Information

Patient must be informed prior to the therapy concerning CryoOne skin

cooling effects. Should the patient feel increased discomfort or

sensitivity to excessive heat or cold, he should inform the Cryo operator

at once.

The airflow level and the distance between the treatment tube’s adapter

and the treatment area should be selected to maximize patient’s

comfort.

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.

Page 10 of 40 EN109-3442254-40

2 Side effects / Residual risks

Side effects

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

chilblains can occur, especially in sensitive patients.

Residual risks

If the device is used within its intended purpose, no other unacceptable

residual risks are known besides the contraindications, the side effects and the

warnings already mentioned.

Page 11 of 40 EN109-3442254-40

3 Application information

3.1 General

Before using the device 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.

The instructions for use must be kept with the device so that it is accessible

at all times to the persons operating the device.

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.

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.

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.

Inspect the device prior to every use. If it is damaged, it may not be used.

Only use accessories designated to be used with the device according to the

intended use.

The device contains no sterile parts or accessories

In foreseeable use, the device has no parts, which are defined to be in

contact with the patient. The user contacts the device housing as well as the

treatment hose.

The device can be moved via the castors to the treatment site. Move the

device only using the provided handle and after transport fix the castor

breaks.

The device is only powered with mains. To separate the device from the

mains, disconnect the power cable on the device or from the wall socket.

Should the CryoOne need to be turned onto its side for maintenance or

transportation, the device needs to stand upright for at least 30 minutes

before it is switched on to avoid compressor damage, furthermore the

defrosted water container located at the side of the device needs to be

checked to insure correct placement.

Page 12 of 40 EN109-3442254-40

3.2 Cryo therapy

Prior to treatment, patients should be informed of the goals and effects of

cold air therapy with CryoOne.

Do not treat patients with wet skin.

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

covered and kept warm.

Joints and musculature require longer treatment, otherwise, only the surface

of the skin and the upper layers of skin are cooled. In case of joint

inflammation, short-term cooling results in a reactive hyperemia.

For diseases of the skeletal and musculoskeletal systems, you achieve the

optimal therapy at a distance of 5 - 20 cm between the air outlet and the

surface of the skin.

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 during

longer treatments. Unfavorable ambient conditions (e.g. ambient

temperature above 95°F (>35°C) and high humidity) may lead to a reduction

in performance (reduced cooling capacity). Do not place the unit in direct

contact with sources of heat (radiators, mud preparations, saunas etc.).

Ensure a distance of at least 50 cm between the unit and the wall to allow air

inflow.

Before starting a treatment check if air is blowing out of the therapy tube. To

treat larger areas, the distance from the air outlet to the skin should be

increased, resulting in longer treatment times for adequate cooling. At a

distance of 5 cm, the cooling spot covers approx. 10 cm2.

Hygienic gloves should be worn during the treatment.

Before treatment, the purpose and effect of Cryotherapy using CryoOne

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.

If necessary, the treatment parameters (air power level and distance to the

treatment area) should be adjusted.

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).

Page 13 of 40 EN109-3442254-40

The device is designed to be operated 8 hours per day, in which a patient

treatment lasts about 15 minutes and the break between two patients is 10

minutes.

Page 14 of 40 EN109-3442254-40

4 Warnings

If CryoOne is connected to another medical device, please observe the

respective instructions for use. The operating instructions may be invalid

in this case.

The device is intended to be used exclusively by medical professionals,

who are familiar with the use and application of the device.

The patient must not be left unattended during therapy.

Dispose of packaging material properly. Keep such material out of reach

of children.

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. The device is only applicable in medical rooms of application group

1 according to VDE0100 part 170.

CryoOne is not designed for use in areas with an explosive, flammable or

combustive atmosphere.

The air stream should be directly evenly over the area to be treated.

Avoid static or excessively intensive cooling as this can lead to cold burns

and hypothermia.

When using CryoOne to skin cooling, do not increase the output of the

laser device beyond the level recommended by the manufacturer.

Skin cooling may reduce effectiveness of some laser treatments when

laser has the identical power output.

Operating the device with settings or treatments other than those in the

operating instructions can lead to risks due to uncontrolled effects of

cold.

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

can occur if the air outlet of the hose is less than 10 cm away from the

skin

To avoid risk of electrical shock, this equipment must only be connected

to supply mains with protective earth.

Page 15 of 40 EN109-3442254-40

The bidirectional RS232 interface is closed by screws. The opening and

Connecting at the RS232 interface must be carried out only by trained

service technician with the proper tools. Only medical devices may be

connected to the interface.

Magnetic and electric fields may affect the operation of the unit. Do not

use CryoOne close to equipment that generates strong electromagnetic

fields (e.g. X-ray or diathermy equipment or nuclear magnetic resonance

tomography devices)

During the transport of CryoOne to other place be careful that the device

does not tilt.

Page 16 of 40 EN109-3442254-40

5 CryoOne – in brief

What is the

CryoOne?

A compact cold air device for treatment of musculoskeletal diseases in

physiotherapy as well as skin cooling in conjunction with dermatological

laser treatments to reduce pain and thermal injury on skin tissue in

dermatology.

What does the

CryoOne do?

Cold air is blown onto the area of the body to be treated using an

adjustable air flow.

How does CryoOne

achieve the

necessary cooling

concentration?

Depending on the surface and accessibility of the treatment area, the

amount of air can be adjusted in nine levels.

Therapy mode and

the Pre-cooling

Phase

The CryoOne is defined as a Slave controller and can be operated by the

Master via capacitive touch display or RS 232 serial communication. After

switching on the device will stay in Wait mode until the CryoOne will be set

into other mode by the display or by the RS232 interface.

The therapy mode consists of 2 phases, the pre-cooling and the therapy

phase.

Once the CryoOne sets into “Therapy mode” the device automatically turns

into the pre-cooling phase until an evaporator temperature of –17°C is

reached, during pre-cooling no therapy start is possible, the device is

“busy”.

When reaching –17°C the device releases therapy but still continues cooling

until the minimum evaporator temperature (-38°C) is reached, therapy can

be started at any time. When reaching the –38°C the device stops cooling

and compressor and condenser fan are turned off. The device remains in

therapy mode until either a therapy starts or a temperature of –20°C is

reached. At this limit the final cooling phase re-starts and cools down the

device again to –38°C.

Page 17 of 40 EN109-3442254-40

6 Intended Use

Intended Use

The device CryoOne is only intended for deep skin cooling of humans in

dermatology or physiotherapy treatment.

User Group

➔ The device CryoOne is intended for persons with medical training,

such as doctors, physiotherapists or other medical trained stuff.

➔ The user should have no visual or hearing impairments as well as

colour blindness.

Target population

group

Patient age: from children up to 6 years to senior citizens

Sex: male and female

Weight: all

Nationality: all

Ethnic group: all

Health state: Patients with cognitive impairments or reduced pain

sensation should not be treated

Page 18 of 40 EN109-3442254-40

7 Device set-up

AC Power

connection

Plug the mains cable into the mains power connector (see Fig. 2)

Fitting the treatment

tube

Insert the treatment tube into the connector (1) according Fig. 4 on the top

of the device and lock it by rotating.

After horizontal transport or assembly, the device must stand upright for at

least 30 minutes prior to being switched on. The compressor might

otherwise been damaged.

Fig 4

Hose connection

Note:

The user is responsible for the use of the device. The device may not be

modified without the consent of the manufacture. The party combining the

device and thus operating a medical system is independently responsible for

combining the devices correctly.

Page 19 of 40 EN109-3442254-40

8 Operation instructions / Device settings

8.1 Switch on and off

1. Switch on Unit

Mains Switch (8, Figure 2).

2. Operating

Status/Therapy

CryoOne may be controlled and operated by the user interface (7 inch

display). Once the Mode sets on “Therapy”, a Pre-cooling Phase

started. When the evaporator temperature reaches –17 °C, the

Therapy can be started.

The fan speed can be adjusted via a up and down button (9) or by

touching in the graph (13).

The therapy time can be adjusted via an up and down button (11) or

by touching in the graph (12).

3. Treatment End

The treatment can only be ended by the touch display with the

start/stop button (10).

If CryoOne is connected to another medical device, please observe

the respective instructions for use. The operating instructions may

be invalid in this case.

Page 20 of 40 EN109-3442254-40

8.2 Startup Display

Fig. 5

Initialisation screen

and pre-cooling

Once the cold air therapy device is turned on, the startup display

appears.

As long as the blue bar runs out, a device initialization/ self-test and

pre cooling of the device is carried out and no therapy can be started.

After this phase, the device switches automatically in the therapy

screen.

Pre-cooling

Once CryoOne is turned on, the device starts to pre-cool to the

minimum reachable temperature. During this phase, the compressor

and the condensor fan work simultaneously.

In parallel, the device performs a self-test. During self-test or pre-

cooling, no entries can be made on the display. Merely the “Menu”

button can be manipulated to reach the configuration menu. When

pre-cooling is sufficient, the display automatically returns to start

screen. CryoOne is now ready for use.

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Enraf-Nonius CryoOne User manual

Brand: Enraf-Nonius

Model: CryoOne

Category: Skin care appliances

Type: User manual

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Enraf-Nonius CryoOne User manual

Enraf-Nonius CryoOne User manual

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