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OSMOMAT 3000 Safety 2.5 Personnel requirements 20 Version 1.02 04/24/2013 WARNING! Risk of injury due to inadequately qualified personnel! Work performed on the device by unqualified personnel or the presence of unqualified personnel in the hazard zone of the device creates risks that can result in serious injury and substantial property damage. - Only have qualified personnel perform any kind of activity. This manual specifies the following personnel qualifications for the different task areas: <strong>User</strong> Based on his or her expert medical and/or pharmaceutical training, knowledge, and experience, the user is capable of safely executing the tasks assigned to him or her. The user is not authorized to perform any start-up activities. The user is capable of independently detecting, evaluating, and avoiding possible risks. The user has the expert knowledge for the intended use of the device and observes all hygiene regulations for rooms used for medical purposes and the use of medical products. The user knows the contents of all applicable regulations, guidelines, and standards required by law for the safe use of the device and is capable of meeting the requirements stipulated therein. Lab supervisor The lab supervisor coordinates and monitors the technical procedures at the installation site of the device. Based on his or her professional training and many years of professional experience with medical devices, the lab supervisor is capable of performing the start-up tasks delegated to him or her by the manufacturer. Service technician Based on his or her professional training in the area of mechanical and electrical engineering, the service technician is capable of performing the tasks related to troubleshooting and servicing delegated to him or her by the manufacturer.
2.6 Personal safety gear OSMOMAT 3000 Safety While performing the different tasks on and with the device, personnel must wear the personal safety gear referenced explicitly in the various sections of this manual. Description of personal safety gear The personal safety gear is explained below: 2.7 Environmental protection Electronic components Sodium chloride Disposable lab gloves Disposable lab gloves protect the hands from touching sample residue. NOTE! Danger to environment due to incorrect handling of handling of environmentally hazardous substances! Incorrect handling of environmentally hazardous substances, in particular incorrect disposal, can result in significant harm to the environment. - Always observe the warnings regarding the handling of environmentally hazardous substances and their disposal below. - If environmentally hazardous substances are inadvertently released into the environment, immediately initiate suitable actions. If in doubt, notify the responsible local authority about the damage and inquire about suitable actions to be initiated. - If environmentally hazardous substances are inadvertently released into the environment, immediately initiate suitable actions. If in doubt, notify the responsible authority about the damage and inquire about suitable actions to be initiated. The following environmentally hazardous substances are used: Electrical components can contain poisonous substances. These must not be released into the environment. Therefore, a specialist disposal firm must be tasked with disposal. The calibration standards contain sodium chloride. Sodium chloride is mildly hazardous to water and must not be released into the environment. Version 1.02 04/24/2013 21
Page 1 and 2: 2/12/2013 User Guide OSMOMAT 3000 V
Page 3 and 4: OSMOMAT 3000 Overview of the OSMOMA
Page 5 and 6: Table of Contents OSMOMAT 3000 Over
Page 7 and 8: OSMOMAT 3000 Overview of the OSMOMA
Page 9 and 10: Device, rear Fig. 2: Device overvie
Page 11 and 12: Accessories Fig. 4: Overview of acc
Page 13 and 14: Special safety notices Safety notic
Page 15 and 16: 2.3.2 Risk of infection Risk of inf
Page 17 and 18: 2.3.5 Reproducibility of the measur
Page 19: Inventory OSMOMAT 3000 Safety The o
Page 23 and 24: Device, rear Fig. 6: Device overvie
Page 25 and 26: Accessories Fig. 8: Overview of acc
Page 27 and 28: 3.3 Measurement equipment Fig. 9: O
Page 29 and 30: Thermistor probe Fig. 11: Thermisto
Page 31 and 32: Enter values Fig. 13: Enter values
Page 33 and 34: 3.6 Connections and interfaces Fig.
Page 35 and 36: 3.6.2 Transfer protocol Output form
Page 37 and 38: 4.1 Packaging About the packaging H
Page 39 and 40: 4.2 Device storage 4.3 Unpack devic
Page 41 and 42: 5.2 Install device Fig. 21: Fan out
Page 43 and 44: 6 Setup Check printer (Option D) Ch
Page 45 and 46: Select calibration standards Fig. 2
Page 47 and 48: 7.1 Power up device Fig. 31: Power
Page 49 and 50: Fig. 33: Start menu Fig. 34: Ice fo
Page 51 and 52: Fig. 40: Move elevator down Fig. 41
Page 53 and 54: Fig. 45: Ice formation Fig. 46: Cal
Page 55 and 56: Fig. 52: Clean thermistor probe 12.
Page 57 and 58: Fig. 53: Clean thermistor probe Fig
Page 59 and 60: Calibrate device using calibration
Page 61 and 62: Fig. 63: Second calibration standar
Page 63 and 64: Configure screen saver Fig. 68: Con
Page 65 and 66: 7.6 Power down device Fig. 72: Powe
Page 67 and 68: 8.2 Notes regarding errors Fig. 75:
Page 69 and 70: Measurement procedure takes longer
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Device cannot be powered up Power s
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Fig. 77: Remove mounting screw Fig.
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Check free movement of initiation n
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Fig. 86: Move elevator down Fig. 87
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Fig. 93: Remove mounting plate 1 Mo
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Fig. 99: Elevator cover with correc
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8.4.3 Replace fine-wire fuses Fig.
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Fig. 108: Pull out printer Fig. 109
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Fig. 114: Pull out printer Fig. 115
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9.1 Service table OSMOMAT 3000 Serv
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Fig. 121: Remove mounting screws Fi
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Install device front panel Fig. 127
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Fig. 131: Lubricate elevator guide
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9.5 Check reproducibility of measur
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11 Specifications 11.1 Dimensions 1
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OSMOMAT 3000 Specifications Power c
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12 Index 2 2-point calibration ....
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T Temperature sensor Replace ......
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Fig. 138: "Safe Transport" menu Fig
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Classification of the IVD OSMOMAT 3
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Before Calling Gonotec Fig. 141: Co
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