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OSMOMAT 3000 Safety 2.4 Operator responsibilities 18 Version 1.02 04/24/2013 The operator of the device must fulfill the responsibilities according to Germany’s Medical Devices Operator Ordinance listed in this manual. In addition, the operator is responsible for learning about and complying with all local laws and associated standards and guidelines applicable at the time the device is used. The device is used for medical-pharmaceutical applications. Therefore, the operator is subject to the legal responsibilities regarding work safety. In particular, the following applies: The operator has to learn about the applicable work safety regulations and determine additional risks resulting from the specific working conditions at the location the device is used by means of a risk assessment. These must be implemented by means of operating instructions for the device. The operator has to learn about the applicable hygiene regulations resulting from the samples at the location the device is used. These must be implemented by means of operating instructions for the device. During the entire operating time of the device, the operator has to verify that the operating instructions created by him/her meet the current body of regulations and update them if necessary. The operator has to determine and lay down the specific responsibilities for installation, operation, troubleshooting, servicing, disinfection, and cleaning. The operator has to make sure that all personnel working with the device have read and understood this manual. In addition, s/he has to provide regular training for personnel and educate them about risks. The operator has to equip personnel with the required safety gear and issue mandatory instructions for wearing the required safety gear. The operator has to make sure that the service intervals specified in this manual are observed. The operator has to make sure that consumables are available in sufficient quantities.
Inventory OSMOMAT 3000 Safety The operator has to maintain an inventory according to Germany’s Medical Devices Operator Ordinance: The following information has to be maintained in the inventory: name, product type, serial number, and year the device was purchased, address of Gonotec GmbH organization-specific ID, if applicable location of operator schedule of safety inspections Store CE-certificate together with inventory. Store inventory so it is accessible to personnel in charge of operating the device at all times. Make documentation available to the responsible authority upon demand. Version 1.02 04/24/2013 19
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: 2.3.5 Reproducibility of the measur
Page 21 and 22: 2.6 Personal safety gear OSMOMAT 30
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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