Instructions for Use
45 Pages
Preview
Page 1
Instructions for Use Cryo 6
USA
Illustrations Front of the Device Fig. 1 4
3
5
6 8
2 1 7
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
Illustrations Rear of the Device Fig. 2
11
10
9
12
Devices and operating elements
9 Air filter 10 Mains switch 11 Power inlet 12 Identification plate
Illustrations Screens and Displays Fig. 3
7
P2
13
10:00
OK
Operating element display
18 Start/ Stop
P
P
14
15
17
16
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
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19
21
7
P2 OK
19.1 23
10:00 Start/ Stop
P
Displays
22
P
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
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 Max 35kg/ 77.16lb
Follow instructions for use
Operation instructions
Serial number
Article number
Manufacturer
Date of manufacture
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
9.
Technical Information
20 21 22 24 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
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
Seite 1
Application Information
2
2.1 General
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.
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Application Information
3
2.2 Cryotherapy
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
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Warnings
3
!
The device may only be used by trained medical personal
!
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!
!
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.
!
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).
!
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.
!
Inspect the device prior to use. In case of damage, it must not be used.
!
Only accessories provided by Zimmer MedizinSysteme GmbH are to be used.
Caution Caution Caution
Caution Caution
Caution
Caution Caution
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.
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Warnings
3
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.
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Cryo 6 - in brief
4
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-ofthe-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.
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Intended Use
5
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.
Seite 7
Device Set Up
6
6.1 Assembly
!
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
!
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. Seite 8
Device Set Up
6
6.1 Assembly
Clamp bearings
Glass plate
Silicon washer Spacer bolts
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.
Seite 9
Device Set Up
6
6.2 Assembling the Supporting Arm 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
Rotating arm Rotatingsupporting support arm
Feed through of glass plate and torsion protection
Supporting arm rod
Supporting arm bracket
Seite 10
Device Set Up
6
6.2 Assembling the Supporting Arm 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.
Grommet Part 1
Grommet Part 2 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.
Thread
!
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!
Seite 11
Device Set Up
6
6.2 Assembling the Supporting Arm Step 3 – Attach the torsion protection and rod The torsion protection is attached to the glass plate spacers as illustrated.
Anti-rotation
Then, the supporting arm rod is inserted from above through the insertion duct and torsion protection and locked into the supporting arm bracket.
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Device Set Up
6
6.2 Assembling the Supporting Arm
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.
- Recesses below - Same bending direction
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.
Seite 13