Daavlin Smart Touch ML24000 Operation Manual

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ML24000 with Smart Touch™ control system
Operation Manual
MNL-00025 [2]
Proprietary and Confidential
Page 1 of 45

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Table of Contents
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Summary of Contents for Daavlin Smart Touch ML24000

  • Page 1 ML24000 with Smart Touch™ control system Operation Manual MNL-00025 [2] Proprietary and Confidential Page 1 of 45...
  • Page 2: Table Of Contents

    Table of Contents 1.0 Introduction ..................5 2.0 Indications for Use ................. 6 3.0 Classifications ................. 6 4.0 Operating Specifications ..............7 5.0 Transport and Storage Specifications .......... 7 6.0 EMC Precautions ................7 7.0 Accuracy ..................8 8.0 Electrical Specifications ..............9 9.0 Labels and Symbols ................
  • Page 3 21.1.1 Search Options ......................25 22.0 Treating a Patient ................. 25 22.1 End of Protocol Treatments ..................28 22.1.1 History........................28 23.0 Changing the Treatment As-You-Go ......... 29 23.1 Changing the Proposed Dose ..................29 23.2 Changing Position....................... 29 24.0 Warning Rules and Authorities ..........30 24.1 Rules for Warning Messages ..................
  • Page 4 31.3.1 Relamping ....................... 41 32.0 Voltage Specification ..............42 33.0 Lamp Specification ............... 42 34.0 Eyewear Specification ..............42 35.0 Troubleshooting ................43 36.0 Spare Parts and Accessories ............43 37.0 Warranty and Contact Information ........... 43 37.1 Limited Warranty Policy .................... 43 37.2 Warranty Coverage .....................
  • Page 5: Introduction

    Daavlin phototherapy unit. Here at Daavlin we are proud of our tradition of development and innovation in the field of phototherapy, and we are honored that you have chosen us for your phototherapy needs. Let’s be clear.
  • Page 6: Indications For Use

    No part of this manual may be reproduced or used for any purpose other than operating the device unless express written consent is obtained from Daavlin. The ML24000 PC, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I –...
  • Page 7: Operating Specifications

    4.0 Operating Specifications Ambient 15°C to 30°C (59°F to 86°F) Temperature: 10% to 95%, non-condensing Relative Humidity: Liquid IPX0 (This device does not have protection against Ingress Rating: ingress of water.) Ocular Hazard 3 Meters (9.84 Feet) Distance: 250 – 500 lux Ambient Luminance: WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
  • Page 8: Accuracy

    The measuring device will maintain a 5% level of accuracy if the device is calibrated every one hundred ™ (100) hours as recommended. The Smart Touch control system will display a reminder message when calibration is due. Please contact Daavlin for Calibration Instructions. MNL-00025 [2] Proprietary and Confidential Page 8 of 45...
  • Page 9: Electrical Specifications

    8.0 Electrical Specifications The device is manufactured in the following electrical configurations. Always refer to the identification label of the device to determine which electrical configuration the device is manufactured to. • Mains Input = 230VAC, 3Φ, 60Hz, 100A; Operating = 230VAC, 3Φ, Line-to-Line •...
  • Page 10 Risk Group 2 Label (CE Devices Only) The following is an example of the information required for the risk label placed on all CE devices. The Xs in this example will be filled in with the correct lamp type, UV spectrum, primary emission range, and the min and max output.
  • Page 11 Symbol Definition Φ PHASE OPERATING INSTRUCTIONS L1, L2, L3 PHASE CONDUCTORS DATA ONLY ETHERNET PORT KEEP DRY CAUTION, CONSULT ACCOMPANYING DOCUMENTS DANGER HIGH VOLTAGE CE MARK LABEL EU REP LABEL (CE ONLY DEVICE) LABEL WIRING MATERIALS LABEL (CE DEVICES ONLY) MNL-00025 [2] Proprietary and Confidential Page 11 of 45...
  • Page 12: Delivery And Inspection

    If damage is discovered after unpacking the unit, save all packing materials and call Daavlin at 1 800 322 8546 for inspection and repair. Note: The delivering carrier must be notified of any shipping damage within twenty-four (24) hours to protect your right to an insurance claim.
  • Page 13: Important Safeguards And Warnings

    Service & Installation Instructions manual. Unauthorized personnel should not open the panels. The Daavlin Service Department should be consulted before any service is performed. • Warning: Prior to each use, always verify that the device is in correct working order and operating condition and plugs, sockets, lamps, and electrical cables and connections are not worn or damaged.
  • Page 14: Equipment & Property Damage Hazards

    14.1 Printer (Domestic Units Only) A printer is provided and should be connected to the Daavlin ML 24000 PC. The printer is used to obtain hard copy records of individual treatment data and treatment history data. Always read, understand, and follow all instructions provided with the printer before putting it in to operation.
  • Page 15: Usb Mass Storage Device

    ID, “Admin”. Upon setup, each user ID, including the “Admin” user ID, is assigned the case sensitive password “daavlin”. Before an assigned device operator can control the system, including the “Admin”, he/she must logon using an established user ID and default password.
  • Page 16: Treating Patients

    ). Upon setup, the Splash screen will disappear, and the User Logon screen will appear ™ Figure 7 User Logon Screen (See ), indicating the Smart Touch software and the Daavlin ML24000 phototherapy cabinet is ready for operation. MNL-00025 [2] Proprietary and Confidential Page 16 of 45...
  • Page 17: Administrator Selection

    Password field. 2. Type the default password in the Password field using the keyboard at the bottom of the display, and then tap the Logon button once. The default password is “daavlin”, and it must be entered in all lowercase letters.
  • Page 18 Figure 7 User Logon Screen Note: The system will now require the administrator to select and setup a new logon password. It is important to remember the new password, as the system will only allow subsequent logon using the new password. Passwords should be kept secret, as the system will record the username in system activity history.
  • Page 19 Figure 8 Change Password Screen Figure 9 Main Menu Screen MNL-00025 [2] Proprietary and Confidential Page 19 of 45...
  • Page 20: New User Setup

    18.0 New User Setup Only authorized users can perform this function. Warning: Entering improper or erroneous data in the New User Setup process could result in serious patient injury. The data entered when setting up a patient will determine which preprogrammed protocol is selected for the patient treatments, and therefore directly impacts the patient’s treatment dose.
  • Page 21: User Logon

    Figure 10 User Setup Screen 19.0 User Logon Warning: It is important that all user’s logout when immediate system activity will not be performed by the user, when the system is left unattended, or when other individuals could have unsupervised access to the system.
  • Page 22: Subsequent Logon

    2. Type the default password in the Password field using the keyboard at the bottom of the display, and then tap the Logon button once. The default password is “daavlin”, and it must be entered in all lowercase letters. Note: The system will now require the user to select and setup a new logon password. It is important to remember the new password, as the system will only allow subsequent logon using the new password.
  • Page 23 5. Type the user’s first name / given name and tap the Tab key. The cursor will move to the M.I. field. Note: Entry of the Patient PIN, Last Name, and First Name is limited to any combination of 1 - 10 alphanumeric characters. 6.
  • Page 24: Selecting A Patient

    Warning: Entering improper or erroneous data in the Patient Setup process could result in serious patient injury. The data entered when setting up a patient will determine which preprogrammed protocol is selected for the patient treatments and therefore directly impacts the patient’s treatment dose. Only highly skilled and trained personnel should perform this function under the guidance of the attending physician.
  • Page 25: Search Options

    Figure 12 Select a Patient Screen 21.1.1 Search Options The three available patient search methods are: • By PIN: In the Select Patient by PIN… field, enter the patient’s PIN and press Go. The Treatment Setup screen or Patient Setup screen, as applicable, will appear. To perform a search using this method, the complete and exact patient PIN must be used.
  • Page 26 Figure 13 Treatment Setup Screen 4. If no variation from the recommended current dose is desired, check the Accept? box for both the primary and secondary treatment (if giving a secondary treatment). If no secondary treatment is Changing the Treatment As- necessary, do not check the secondary Accept? box.
  • Page 27 Figure 14 Treatment in Process Screen 6. Press Begin Treatment or press the yellow Lamp button on the inside button box to start the treatment process. After a ten second delay, the lamps will turn on and the treatment will begin. To cancel the treatment without proceeding, press Exit.
  • Page 28: End Of Protocol Treatments

    Figure 15 Treatment Complete Screen 22.1 End of Protocol Treatments Upon entry of all treatments the operator will be prompted with a message asking them if they would like to add a treatment to the protocol. The operator must select “Yes” before selecting any other field to add a subsequent treatment or “No”...
  • Page 29: Changing The Treatment As-You-Go

    23.0 Changing the Treatment As-You-Go Warning: Entering improper or erroneous data when changing the treatment dose as-you-go could result in serious patient injury. Be sure to understand How Protocols Work before changing a patient’s treatment dose. Only highly skilled and trained personnel should perform this process. 23.1 Changing the Proposed Dose Only authorized Users can perform these functions.
  • Page 30: Warning Rules And Authorities

    24.0 Warning Rules and Authorities ™ The Smart Touch control system has been designed to provide flexibility in providing treatments while ensuring safety and protection from poor judgment. When an operator whose authority is limited to treating within established limits enters a dose that is beyond those limits, the system responds in two ways: A warning is displayed, denoted by a gray message window when a dose is entered that is slightly beyond limit.
  • Page 31: Edit Patient Data

    • The operator changes a dose to a value that is greater than the largest difference between consecutive treatments for that treatment schedule. • If the time since the last treatment is greater than the Maximum Time between Treatments (Authorization is Not Required) but less than the Maximum Time between Treatments (Authorization is Required).
  • Page 32: Delete

    25.2 Delete To delete the data for the selected patient, tap the Delete Patient button once. A window will appear as a reminder that this action cannot be undone. To proceed with permanently deleting the patient and all records associated with the patient, tap the Yes button once. To exit back to the patient edit screen without deleting the patient and all associated records, tap either the No button once or the Cancel button once.
  • Page 33: End Of Protocol - Maintenance Treatments

    26.2 End of Protocol – Maintenance Treatments When a patient’s protocol has reached its end (becoming maintenance therapy), the User must establish the dose for each subsequent treatment. This operates the same as if the patient was on an As Required Protocol.
  • Page 34: Patient Specific Protocols

    Figure 19 Global Protocol Setup Edit Screen Warning: Changing protocols can be dangerous and can result in treatments that will seriously injure patients. Be sure to understand How Protocols Work before making any changes to protocols. Always review the entire protocol after changes have been made and before it is implemented for use. Only highly skilled and trained personnel should perform this process.
  • Page 35 4. Tap once on the View/Edit Schedule button once. While the data is obtained, the “Retrieving Schedule” message will be displayed. When the schedule is located, the message will disappear, Figure 20 Patient and the applicable Patient Protocol Setup edit screen will be displayed (See Protocol Setup Edit Screen (UVB) Figure 20 Patient Protocol Setup Edit Screen (UVB) Warning: Changing protocols can be dangerous and can result in treatments that will seriously injure...
  • Page 36: System Settings

    ® Caution: Never edit settings in the Windows operating system Control Panel that are not described in this manual without first consulting Daavlin. Changing these settings may cause system failure. 27.1.1 Treatment Variables Figure 21 Treatment Variables Screen The settings contained in the Treatment Variables screen (See are described below.
  • Page 37: Lamp Information

    Figure 21 Treatment Variables Screen 27.1.2 Lamp Information The settings contained in the Lamp Information screen are described below. • Hours since last re-lamp – displays the number of hours that the current lamps have been in operation. The field for the corresponding lamp type is reset to zero when the Re-lamp UVA-1 button is pressed.
  • Page 38: Generating Reports

    2. From the Main Menu, select the User Setup button by tapping it once. The Select a Username Figure 22 Select a screen will appear which includes a list of all established system users. (See Username Screen 3. Select the user profile to be edited by tapping the Username once. The User Setup screen will Figure 10 User Setup Screen appear (See Figure 22 Select a Username Screen...
  • Page 39: Generating A Daily Summary Report

    4. Tap the Generate Report button once to create the individual report. 29.2 Generating a Daily Summary Report 1. From the Reports Menu, tap the Daily Summary Report button once. The Daily Summary Report screen will appear. 2. On this screen select either the ForToday or ForTheDate checkbox. ForToday Reports will show information for all the current day’s treatments.
  • Page 40: Restoring The Database From The Removable Usb Drive

    Note: If a backup to the removable USB device has not been recently performed, or if such backup has never been performed, please contact the Daavlin Service department at 1-800-322- 8546. Database restoration may still be possible from backup files automatically stored on the computer.
  • Page 41: Cleaning

    31.2.3 Filter A trained technician should clean the internal filters and cavities of the machine annually. Do not attempt to clean these filters without proper training, as certain solutions may damage the filters. Only Daavlin authorized personnel should perform this function.
  • Page 42: Voltage Specification

    which could be harmful to the patient. Always return lamp filters to their original position after relamping. Follow all federal and local regulations when relamping and disposing of discarded lamps. Note: Always measure lamp intensity before and after lamp replacement. It is important to notify everyone concerned that the lamps have been replaced as patient exposure times may need adjusting.
  • Page 43: Troubleshooting

    37.0 Warranty and Contact Information 37.1 Limited Warranty Policy This Limited Warranty is provided to the original purchaser (the “Purchaser”) of the Daavlin device (the “Equipment”). Daavlin warrants Equipment to conform with the Equipment specifications and be free from defects in material and workmanship during the device Warranty Period.
  • Page 44: Warranty Coverage

    Limited Warranty. In such situations, Daavlin will cover freight expenses in the continental USA to ship products covered under warranty both to and from Daavlin’s servicing center if the product fails during the first three months.
  • Page 45: Disposal

    Daavlin. Even with Daavlin’s authorization, Daavlin shall not be responsible or liable for any such work (in or out of warranty). Daavlin reserves the right to bill for labor, expenses, and services for requested "warranty" service trips which result in work not covered by this Limited Warranty.

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