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Related Manuals for RAUMEDIC MPR1
Summary of Contents for RAUMEDIC MPR1
- Page 1 Instructions for Use MPR1 DATALOGGER Instructions for Use MPR1 DATALOGGER REF 094474-001 and 094474-002 Firmware versions 2.10.0070 and 2.10.0070 HW2 Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 1 of 98...
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Page 2: Table Of Contents
2.6.3 Remark- and warning symbols on the packaging label ............15 Abbreviations ..........................16 Code designations on the connection sockets of the MPR1 ............16 Catheter location and signal designations ..................16 3 Patient monitoring ..........................17 ECG ............................... 17 Cabled invasive pressure measurement .................. - Page 3 ..........................71 4.9.6 Summarisation ........................71 4.9.7 Verifying the alarm system ..................... 72 5 Power supply ............................73 Mains power supply ........................73 Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 3 of 98...
- Page 4 11.2.3 Atmospheric pressure ......................95 12 Environment and disposal........................95 13 Liability and warranty .......................... 95 14 Index ..............................96 15 Enclosures ............................97 Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 4 of 98...
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Page 5: General Notes
• out by the manufacturer himself or persons authorised by the said. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 5 of 98... -
Page 6: Safety-Related Information
MPR1: Establish the cable connection; check the signal transmission; and set the alarm limits to the foreign system. Prior to using the MPR1, the correct condition of the apparatus and any accessories shall have to be •... - Page 7 Hand over the apparatus to the after-sales service department for inspection. Subsequently a safety-related check is necessary. The MPR1 has been designed in conformity with standard IEC 60601-1. It is a product of class of •...
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Page 8: Description Of The Device
2.2.4 Physiological purpose The use of the MPR1 is indicated, if the intention is to obtain information for the treatment, to assess the appropriateness of the treatment, or to exclude the cause of symptoms. 2.2.5 Patient population Please refer to the instructions for use of the catheter used for the application. -
Page 9: Application In Connection With Electrosurgical Units
Devices that meet the requirements of IEC 60601-1-2:2007 (for differentiation, see Section 10 Electromagnetic compatibility) are contraindicated for simultaneous use with electrosurgical devices. The unit is not intended for use outside of the hospitals, such as in helicopters or in ambulances. The MPR1 is not intended for use in domestic settings. -
Page 10: Keys With Dedicated Functions
The unit has eight context-sensitive defined function keys (F keys). The F keys are located in the right-hand bank of keys directly next to the display. Their current functions are shown in the appertaining monitor area. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 10 of 98... - Page 11 (flashing yellow LED). Display. [9] to [16] Soft keys, also referred to as F keys. [17] Connection field. Table 1: Keys and functions Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 11 of 98...
- Page 12 Temp-2: connection for temperature probe, channel 2 (cf. 4.4.4 Transducer for temperature measurement) Figure 3 Figure 4 Optional stand holder [29] Optional table holder [30] Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 12 of 98...
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Page 13: Information And Warning Symbols
LED to signal ON / OFF and stand-by (flashing green LED for battery-pack operation and stand-by, green LED 100 per cent mains operation. Flashing red LED, if alarm has high priority. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 13 of 98... -
Page 14: Information And Warning Symbols On The Bottom Side And The Type Plate Of The Unit
The caution sign above the patient connections indicates that only accessory parts authorised by the manufacturer may be connected up to RAUMEDIC MPR 1 DATALOGGER. In this respect, please observe the instructions for use. Analogue outputs Out-1 [25] and Out-2 [21]. -
Page 15: Remark- And Warning Symbols On The Packaging Label
Temperature limit Reference number Serial number The device meets the essential Requirements of the European Directive 90/385/EEC and 93/42/EEC Table 3: Information and warning symbols Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 15 of 98... -
Page 16: Abbreviations
Single Fault Condition Serial Number Short Play memory mode Safety check Telemetry catheter Code designations on the connection sockets of the MPR1 connection socket for ecg cable Ext. connection socket for device extension (RS232) Out-1 connection socket for analogue output 1... -
Page 17: Patient Monitoring
ICP. The ECG channel is type CF and has been classified as protected against defibrillation. The ECG channel of MPR1 can be used for simple bipolar lead (preferably according to Eindhoven II) with display of the heart rate. -
Page 18: Cabled Invasive Pressure Measurement
The ECG connection [18] corresponds to type CF, and in connection with the ECG cable it is protected against damage caused during defibrillation. Nonetheless, please keep a minimum distance of 15 cm between the ECG and the defibrillation electrodes. Caution ! The MPR1 is not suitable for a diagnosis of the ECG during or after defibrillation! Direct-current potentials caused by electro-chemical processes on the ECG electrodes may have a negative effect on the ECG lead. -
Page 19: Preparation Of The Invasive Pressure Measurement
Instructions for Use MPR1 DATALOGGER The MPR1 has three input sockets P1, P2, P3, to which up to three transducers or micro-chip precision pressure catheters can be connected. By means of the software, pressure inputs can be allocated to different measuring locations. -
Page 20: Preparation Of The Invasive Pressure Measurement With Micro-Chip Precision Pressure Catheter
P1, P2 or P3 of the MPR1. When required, choose another measuring point. Select the “Zeroing RAUMEDIC Catheter” zeroing option when the RAUMEDIC precision pressure catheter has been connected! Please observe the instructions for use of the accessories, such as cable and catheter. If limitations apply in the permissible measuring range or in the protection against defibrillation, for example, the said shall have to be adhered to by all means. -
Page 21: Zero Calibration
Instructions for Use MPR1 DATALOGGER Figure 7: Measurement with micro-chip precision pressure catheter 3.2.2.3 Zero calibration There are three options to be selected from in the Zero calibration menu of the MPR1: Zeroing RAUMEDIC catheter • Retention of zero value •... -
Page 22: Retention Of Zero Value
This zero value saved in the MPR1 will be taken over when the pressure catheter is connected again and when the “Retention of zero value” option is selected. -
Page 23: Telemetric Measurement Of The Icp
Implant the telemetry catheter • Connect the reader TDT1 readP to the MPR1 by plugging the plug with the black marking into the black socket “Ext.” of the MPR1. In contrast to cabled pressure measurement, when using telemetry catheters no zeroing is required before their implantation, nor is any possible. - Page 24 Reader- aerial 17 mm Telemetric catheter Please note that it takes several second to make the connection between the reader and the telemetry catheter. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 24 of 98...
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Page 25: Measurement Of The Body Temperature
As soon as the temperature sensor has been connected to one of the sockets [27] or [28] and is subjected to a temperature of at least 15.0° Celsius, the MPR1 will show the room temperature in the respective temperature channel field [7] of the display. -
Page 26: Cleaning, Disinfecting And Sterilising The Temperature Sensor
Please keep in mind that the errors in the pressure display multiply on the third-party system when analogue outputs are used. Error of the pressure sensor + error of the pressure amplifier of the MPR1 + error of the analogue output + error of the pressure amplifier of the third-party system. When using the analogue output, it is imperative that you proceed in keeping with chapter 4.6.1 Combine analogue... -
Page 27: Pc Interface
Use approved accessories only. Never try to carry out hardware extensions yourself which are not supported by the firmware of the MPR1. Every person who connects an additional unit to the signal input or signal output configures a medical system, and thus he / she shall be responsible for the fact that this system meets the requirements of standard IEC 60601-1-1. -
Page 28: Operation Of The Mpr1
On LED starts flashing (top left-hand side on the operating panel). If the MPR1 is to be operated by means of the mains adapter supplied, it has to be connected to the mains voltage. Now connect the red connector of the mains adapter cable with the red socket of the MPR1. Please keep in mind that only one approved electrical appliance may be connected to the mains adapter. -
Page 29: Data Field
Further, you can in this view read off the firmware version • • delete the patient data saved define a new patient • • select the memory mode Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 29 of 98... -
Page 30: General Notes On The Key Functions
You should decide in favour of erasing if you want to ensure a maximum of recording time. For irretrievable erasure of the data saved, press the Del delete key. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 30 of 98... -
Page 31: Open A New Patient Documentation
If you want to open a new patient documentation, you need not do anything and can continue with the selection of the memory mode. If you want to continue with the last patient, press the Menu key first of all Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 31 of 98... -
Page 32: Selecting The Memory Mode
The option "Continue measurement" can only be selected, if data of a previous patient is still saved on the MPR1. If the data stored on the MPR1 has been deleted (see point. 4.2.2 Deleting the memory), then a new patient is automatically created. - Page 33 When you close the window, you go to screen . "Alarm limits selection" 4.3 Alarm limit selection is reached first, provided "New patient" was selected. Under "Continue measurement" this step is omitted. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 33 of 98...
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Page 34: No Storage
Data is stored on the device. The user has the option of backing these up before deletion (Select No). If Yes is selected, the data are irrevocably deleted. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 34 of 98... -
Page 35: View Last Measurement
Open Function menu. Using the arrow keys select the function "View last measurement". Software version Confirm with OK. This function is only available if data are stored on the device. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 35 of 98... -
Page 36: Alarm Limit Selection
By pressing the Std key, the alarm limits from the operator settings are activated. Thus for constantly repeating, similar, monitoring tasks, the time consuming setting of alarm limits is simplified. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 36 of 98... -
Page 37: Connecting The Transducer
Connecting the transducer The MPR1 has six input channels, to which up to six application units can be connected. As a rule you need connection cables for the purpose. For this reason, please only use those recommended in the list of accessories. -
Page 38: Ecg
Caution! The MPR1 has not been approved for direct use on the heart. The MPR1 can be used to lead off a simple single-channel ECG with the display of the heart rate. Connect the ECG cable to the MPR1, using the round connector of the ECG cable (with blue marking) in the blue socket (ECG). -
Page 39: Ecg Settings
HR --- is indicated instead. This is also the case, when the heart rate is out of range. The heart rate is not monitored. For this reason, there is no menu to set the limiting alarm values. Error message Info Signal out of range Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 39 of 98... -
Page 40: Ecg Graphics
The following functions are available for the display of the trend: Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 40 of 98... -
Page 41: Transducer For Invasive Pressure Measurement
The same applies corresponding, if you want to connect further pressure sensors. You have already opened a new patient document and the memory mode has been set. The MPR1 recognises that you have connected a pressure sensor to socket P1. In this screen you can select the measuring location and the process for the zero calibration. - Page 42 Press the Menu key and selected the zeroing procedure recommended for the pressure sensor. The default setting in this menu is “Zeroing RAUMEDIC catheter”. Prior to zeroing, please ensure that the pressure sensor is subjected to the pressure conditions described in the instructions for use.
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Page 43: Invasive Pressure Measurement Settings
In this window you can use the arrow keys to select whether you want to set alarm limits and whether the limiting value monitor of the selected measuring value is to be active or not. In addition, select the measured value to be monitored. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 43 of 98... - Page 44 4.9.1 Physiological alarms. In order to change the settings, use the arrow keys to navigate to the requested parameter and then press the Menu key. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 44 of 98...
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Page 45: Changing Limiting Alarm Value Settings For Invasive Pressure Measurement
Active. If you want to change other settings or repeat a setting, press the ICP1 key or the key of another measuring location again. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 45 of 98... -
Page 46: Activating And Deactivating The Alarms
4.4.3.3 Connecting analogue outputs The MPR1 has two analogue outputs. You can forward any two selected pressure signals of type ICP (ICP1, ICP2, ICPT) to an external system via the analogue outputs. The pressure signals can be any two pressures, including the ICPT. For more information see point 3.5 Analogue outputs. You can activate the... -
Page 47: Pressure Graphics
30 mm/s correspond to approx. 3 s per display width. Use the key to reduce the plotting speed, increasing the time basis of the curve. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 47 of 98... -
Page 48: Invasive Pressure Trend
Finer temporal resolution Coarser temporal resolution Rough backward navigation Fine backward navigation Fine forward navigation Rough forward navigation Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 48 of 98... -
Page 49: Measuring The Cpp
4.4.3.6 Measuring the CPP If an invasive pressure input is configured as ICP (ICP1 or ICP2) and another as ART on the MPR1, the operand CPP (Cerebral Perfusion Pressure) is calculated automatically. If two pressure channels have been configured as ICP, thus ICP1 and ICP2, the CPP is always calculated from ART and ICP1. In screen the CPP is displayed as a numerical value in the lower text line. -
Page 50: Changing The Temperature Settings
Proceed correspondingly, if you want to change the settings for temperature T2. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 50 of 98... -
Page 51: Setting The Limiting Temperature Values
. The temperature is displayed in the footer of the graphics screen in the form of a numerical value, cf. 4.4.4 Transducer for temperature measurement. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 51 of 98... -
Page 52: Temperature Trend
Socket for the connection of the TDT1 readP If the reader TDT1 readP is connected to this socket, then it is automatically recognized by the MPR1 and the search run for a telemetry catheter is started. The time of the search run is indicated by the timer in the ICPT table field (see 6.14 Reaction to fault messages and indications). - Page 53 P1, P2, P3, but rather instead of the catheter connected to P1. At the MPR1 the catheter which was previously plugged in to the MPR1 has initial priority. Additionally a technical alarm is triggered for P1. The user is informed of this by a corresponding indication.
- Page 54 Telemetric ICPT measurement If no telemetric connection can be created or if the telemetric connection is interrupted or lost, the following display is output: Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 54 of 98...
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Page 55: Making Icpt Settings
Instructions for Use MPR1 DATALOGGER 4.4.5.1 Making ICPT settings In order to be able to make ICPT alarm and threshold settings, it is necessary that a telemetry catheter has been recognized by the MPR1 and the ICPT is displayed. further settings alarm limits 4.4.5.2... -
Page 56: Measuring The Cpp Using The Icpt
Tracks can be deselected until no curve is visible any more. In this case, the display will render “With Shift + channel name you can switch between curves”. The procedure in screen 2 and 3 is identical. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 56 of 98... -
Page 57: Device Setup
Set the external system alarm limits to maximum 350 mmHg, if monitoring is required. Establish the cable connection between an analogue output of the MPR1 and an pressure input of the third- party system. Here it is immaterial whether you use Out-1 or Out-2 on the MPR1. Now skip to the setup screen... - Page 58 In case of non-observation, the third-party system will not release an alarm when the pressure sensor is removed from the MPR1 or is damaged. The analogue output of the MPR1 will read at least 355 mmHg, if the pressure sensor is removed from the MPR1.
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Page 59: Device Diagnostics
The version of the software with the hardware level HW2 is intended for devices without ECG applied part. Devices of earlier delivery date can have a lower version of the software. With respect to the firmware, the MPR1 can be updated. Please get in touch with the manufacturer to check the availability of a new firmware version. -
Page 60: Setting The Lcd Contrast
Step 3: Call the device setup and press Press the Menu key. Use the arrow keys to change to the Dis key. the requested language. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 60 of 98... -
Page 61: Setting Date And Time
PC two files are created, one for the time prior to the time setting and one for the time after. Thus, the data cannot be viewed continuously. On the MPR1, the trend data from the time prior to the time setting will not be displayed any more. They will remain saved, however. - Page 62 Press the ESC key to return to the previous step. Complete your settings by pressing the OK key. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 62 of 98...
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Page 63: Modifying The Scaling
The arrow keys are used to change the requested settings, such Setup Subsequently close the window by pressing OK. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 63 of 98... -
Page 64: Activating The Key Lock
Step 2: Step 3: Skip to the overview screen and Subsequently press the F5 key The key lock is active. press the Shift key. (key). Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 64 of 98... -
Page 65: Switching On The Lcd Background Illumination
Apparatus alarms (see point 4.9.4.1 Apparatus alarms) Sensor alarms (see point 4.9.4.2 Sensor alarms) • Alarms are differentiated according to their priority. The MPR1 has high and medium priority alarms. High priority alarms: all pressure alarms with the exception of the CPP •... - Page 66 If this button alarm is pressed for two seconds, then all acoustic alarms are globally suppressed for an adjustable pause time or until the button is pressed again or until the MPR1 is switched off. The alarm suppression state is permanently indicated by a flashing symbol in the info area (crossed through, dotted line bell symbol) and a countdown timer.
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Page 67: Physiological Alarms
Muting / reset only switches off the acoustic signal. The value flashes until it is outside of range. If an alarm limit is set to an extreme value (outside the physiological normal range), then the alarm system can be rendered useless. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 67 of 98... -
Page 68: Factory Settings
*1 The alarm limits can be adjusted freely within the range given; the minimum distance between upper and lower limit has to be one step width. 4.9.2.2 Inactivate alarm signal switch Global audio suppression for a duration of 10 minutes Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 68 of 98... -
Page 69: Scaling
In conjunction with the info-message, this alarm behaves like a sensor alarm. Once the info-message is seen, the alarm is deleted and only the memory full indicator flashes. (3) Internal fault (such as failure of reference measurement) Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 69 of 98... - Page 70 "The implant probably has a hardware fault." • "There is an error in the implant data. A measurement process cannot be carried out. If possible, • use another implant." Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 70 of 98...
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Page 71: Sensor Alarms
(short keypress) as well as for global muting / reset and global suppression (long keypress). Figure 11: Alarm diagram Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 71 of 98... -
Page 72: Verifying The Alarm System
4.6.2 Device diagnostics. Please observe when verifying the alarm system that alarms of high and medium priority are tested according to the table rendered above. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 72 of 98... -
Page 73: Power Supply
The battery is charged in the MPR1 as soon as it has been connected to the external mains adapter. The battery is protected against overcharging. The MPR1 has been equipped with a deep-discharging protection system. -
Page 74: Battery Maintenance
The use of energy sources not explicitly approved of for this apparatus may lead to damage and hazards. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 74 of 98... -
Page 75: Troubleshooting
General instructions • MPR1 and accessories are not damaged, i.e. have no cracks or loose parts. • All patient cables have been connected to the MPR1 correctly (correct mechanical and colour coding of plug and monitor input socket). • The alarm settings are suitable for the new patient. -
Page 76: Error - Zero Calibration Of Pressure Channel
If no mains operation is possible, switch on the apparatus and off again after a few seconds. Avoid a longer period of storage in discharged condition. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 76 of 98... -
Page 77: Pressure Sensor Has Been Removed
Here the user cannot use the selected analogue output. A continuation of the logger operation without the use of the analogue output concerned is possible at any time. The fault can be remedied by the after-sales service department only. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 77 of 98... -
Page 78: Defective Fuses
Instructions for Use MPR1 DATALOGGER 6.13 Defective fuses The MPR1 has been equipped with a safety fuse. If the fuse is defective, the MPR1 is no longer operational. The fuse is accessible when the cover to the battery-pack compartment is open. - Page 79 The implant probably has a hardware fault. Fault T28 There is an error in the implant data. A measurement process cannot be carried out. If possible, use another implant. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 79 of 98...
- Page 80 • Messages on the MPR1 when setting up the telemetric connection. If a TDT1 readP reader is connected to the MPR1, the unit will try to build up a connection to the telemetric catheter. At the same time, a timer will be started, and the time for searching a telemetric catheter is displayed.
- Page 81 In case of an interruption of the data transmission, the user cannot download the data currently saved on the MPR1 because the PC does not have the information. In this case, the process has to be repeated.
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Page 82: Cleaning And Maintenance
When removing the line, always get hold of the plug and never pull the line. The MPR1 can be cleaned with a slightly moist cloth. Please make sure that no liquid can penetrate into the housing through the openings or the connecting sockets because this would damage the apparatus or would impair its operational safety. -
Page 83: Sterilisation
The mains adapter is not protected against moisture, and thus it must not get into contact with liquids. If and when required at all, use a dry soft cloth to clean the mains adapter. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 83 of 98... -
Page 84: Inspections, Safety And Measurement Checks
(medical electronic thermometers) at least every two years. The Datalogger MPR1 is a device with an electric temperature measurement function. If the Datalogger MPR1 is operated in combination with the Reader TDT1 readP and a NEUROVENT-P-tel, it is subject to legal requirement for safety check according to Medical Devices Operator Ordinance (MPBetreibV) §11 in conjunction with Annex 1 point 3. -
Page 85: Accessories
Instructions for Use MPR1 DATALOGGER Accessories Use accessories only, which have been approved by RAUMEDIC. Use of non-approved parts may lead to damage on the system or faulty measurements. Please refer to the following 2 tables for the order designation of the approved accessories: Article No. -
Page 86: Electromagnetic Compatibility
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MPR1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 87: Electromagnetic Emissions
Instructions for Use MPR1 DATALOGGER 10.1.3 Electromagnetic emissions The MPR1 is intended for use in an electromagnetic environment as specified below. The operator or the user of the MPR1 should ensure that it is operated in such an environment. Measurement of Immunity... -
Page 88: Manufacturer's Declaration On The Emc Requirements According To Iec 60601-1-2:2007
Instructions for Use MPR1 DATALOGGER 10.2 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2007 The MPR1 devices fulfil the requirements of IEC 60601-1-2:2007 Note: Special precautions in respect of electromagnetic compatibility (EMC) must be taken for medical electrical devices and the devices must be installed and operated in conformance with the EMC details contained in this instruction manual. -
Page 89: Electromagnetic Emissions
11.1 Technical data, device use could lead to inaccurate results. 10.3 Electromagnetic emissions The MPR1 is intended for use in an electromagnetic environment as specified below. The customer or user of the MPR1 should ensure that it is used in such an environment. -
Page 90: Electromagnetic Immunity
10.4 Electromagnetic immunity Guidelines and manufacturer declaration - electromagnetic immunity The MPR1 is intended for use in an electromagnetic environment as specified below. The customer or user of the MPR1 should ensure that it is used in such an environment. - Page 91 If the measured field strength at the site in which the MPR1 is used, exceeds the above conformity threshold, the MPR1 should be monitored, to demonstrate that it is functioning correctly. If unusual characteristics are observed, additional measures may be required, e.g.
- Page 92 Recommended safe distances between portable and mobile RF telecommunication equipment and the MPR1 The MPR1 is intended for use in an electromagnetic environment in which RF interference is controlled. The customer or user of the MPR1 can help to avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunication equipment (emitters) and the MPR1 - dependent on the output power of the communication device as specified below.
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Page 93: Technical Parameters (Specification)
MAP of > 320 mmHg and in addition a test pulse of approx. +70 mmHg meet upon each other, there is a very low probability that this would cause a technical alarm ?. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 93 of 98... - Page 94 *2: The fuse may be replaced by trained staff only. If the apparatus does not operate after the first replacement, remove the fuse again and take the apparatus to the after-sales service department for repair. The fuse can be obtained from the manufacturer, if necessary. Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 94 of 98...
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Page 95: Environmental Conditions
The box is 100 per cent recyclable. All parts of the MPR1 have been marked and can be separated, re-used or disposed of by specialised enterprises. The mobile power supply is by NiMH type battery pack which is free from cadmium. -
Page 96: Index
Operating and storage temperature · 95 Changing limiting alarm value settings for Operating elements, connections, displays · 9 invasive pressure measurement · 45 Operation of the MPR1 · 28 Cleaning · 26, 82, 83 cables · 82 PC interface · 27 cleaning of the monitor ·... -
Page 97: Enclosures
The observation of the process defined in Directive 93/42/EEC is subject to monitoring by the “notified body”: TÜV SÜD Product Service Ridlerstrasse 65 80339 München Germany Identification No.: 0123 RAUMEDIC AG 0123 Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 97 of 98... - Page 98 Adherence to the processes specified in directive 90/385/EEC is covered through the monitoring by the "notified body": TÜV SÜD Product Service Ridlerstrasse 65 80339 München Identification No.: 0123 RAUMEDIC AG 0123 Manufacturer: zwo-399EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16 Page 98 of 98...