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OPERATOR'S GUIDE
Volumetric
Infusion Pump
Introduction
Great care has been taken in the design and manufacture of the
Optima PT, a volumetric infusion device.
The configuration flexibility of the Optima PT provides overall
improvement in the working conditions of medical teams, thus increasing
patient safety.
The use of this material requires great care. The user must be able to
handle the instrument properly and must know how to fully operate.
Please read the operator's guide carefully before putting the device into
use.
OPTIMA
Table of contents
1.
Operations for use ........................................................................ 2
2.
Advanced functions ...................................................................... 4
3.
Internal safety features ................................................................. 7
4.
Performances .............................................................................. 10
5.
Optima PT - Technical characteristics ...................................... 11
6.
Configuration menu .................................................................... 13
7.
Intended Use................................................................................ 15
8.
Precautions to be taken .............................................................. 15
9.
environment ........................................................................................... 16
10.
Maintenance recommendations ................................................ 18
11.
RS 232 connection ...................................................................... 19
12.
Nurse call connection ................................................................. 19
13.
Function with the internal battery ............................................. 19
14.
Accessories ................................................................................. 20
15.
Disposable ................................................................................... 21
16.
Conditions of guarantee ............................................................. 22
17.
Useful addresses ........................................................................ 24
PT
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Summary of Contents for Fresenius Kabi OPTIMA PT
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Page 1: Table Of Contents
Performances ................10 Optima PT - Technical characteristics ........11 The configuration flexibility of the Optima PT provides overall Configuration menu ..............13 improvement in the working conditions of medical teams, thus increasing ... -
Page 2: Operations For Use
Installation of the Optima PT 1.2.3. Switching on and installation of the infusion set Special attention must be paid to the stability of the Optima PT. The Optima PT can be used on mains or battery Open the pump door by lifting the door handle. The pump automatically Note: connect device to mains as often as possible to recharge switches on when connected to mains (if configured). - Page 3 Connect set to IV Infusion site according to good clinical practices. Program and start infusion as indicated above. Press to start infusion. 1.9. Turning off the Optima PT Press , then for more than 2 seconds. 1273-12_nu_optima_pt_eng_260516.doc - 3 -...
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Page 4: Advanced Functions
Advanced functions When activated in the configuration menu, all advanced functions can be reached by pressing Then, press to reach required item and to enter desired screen. Loading dose Bolus Bolus Pressure Ramp up / Down Secondary Secondary Total volume Sequential Pause Keys locked... - Page 5 2.5. Secondary infusion 2.6. Programming pause Press twice, or reach programming pause with key. 2.5.1. Definition Select pause duration in minutes and hours with This programming mode enable the infusion of a secondary line placed Confirm with . After the pause has ended, an auditing signal is above, automatically followed by the infusion of a primary line placed emitted.
- Page 6 2.9. Ramp up/Ramp down 2.11. Micro Infusion Flow Rate By setting ramp up and ramp down duration, the pump will When the micro infusion flow rate is activated (see Configuration automatically increase the flow rate to reach in ten intermediate menu), a decimal digit is displayed both for flow rate and for volume.
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Page 7: Internal Safety Features
Internal safety features The Optima PT has a continuous inspection system that functions as soon as the pump is in use. Any internal failure or anomaly detected will be immediately displayed. Nevertheless, the qualified personnel in your establishment or our Technical Service should always be notified of any abnormal function where no specific cause can be found. - Page 8 Check pressure threshold accordance with flow rate. Battery life is low. Connect Optima PT to the mains. Low battery pre-alarm. Infusion continues. The pre- alarm is activated at least 30 orange (on front panel) min before the battery alarm when the battery is properly charged.
- Page 9 3.2. Quick check This test is recommended or mandatory (in case of in-force law). It allows a complete alarm and safety features check of the Optima PT (no patient connected). Serial number (ID/N):__________________________________ Date: _____ / _____ / _____ Department: ______________________...
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Page 10: Performances
Performances 4.1. Flow rate available from keyboard 4.8. Change set interval selection We recommend changing the set after 24 hours and/or 2.5 liters for very From 1 to 1000 ml/h, 1 ml/h increment. tight flow rate accuracy (check local protocols). In micro infusion mode: from 0.1 to 100 ml/h, 0.1 ml/h increment. -
Page 11: Optima Pt - Technical Characteristics
Optima PT - Technical characteristics 5.1. Mains power supply 5.6. Symbols Warning: The operator's guide should be completely Use the power cable supplied with the pump. To disconnect the device, read prior to use the device remove the power cable from the mains sockets. - Page 12 5.10. Curves Trumpet curves demonstrate the evolution of the minimum and maximum variance of the PUMP / SET combination versus flow rate. The test protocol used to obtain these results is described in the EN 60 601-2-24:1998. For further information, please refer to this publication. Use these curves to determine the accuracy depending upon your infusion protocol / drug / dilution.
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Page 13: Configuration Menu
Configuration menu Fresenius Kabi recommends the presence of its qualified personnel or a member of the Technical Department of your establishment to help you implement the configuration procedures you wish to choose. Note: press to cancel modification at any time - Press OFF to leave configuration mode at any time. - Page 14 6.3. Ward setting Ward setting Enter code with , and confirm by pressing (pre-set code is 200). Ward setting Select required item with and enter the required item by pressing Code Ward name Select desired letter with . Shift to next letter with Rea-Cardio ----- Confirm setting by pressing...
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Page 15: Intended Use
(no leak, no air, especially after the air bubble Fresenius Kabi will not be responsible whatsoever for use of any interface sensor). communication between the Optima pump and computer systems. -
Page 16: Guidance And Manufacturer's Declaration On Electromagnetic Environment
Guidance and manufacturer's declaration on electromagnetic environment The Optima pump has been tested and found to comply with the applicable standards for electromagnetic Compatibility for Medical Devices. These standards are designed to provide adequate immunity to prevent undesirable operation of the Optima pump, as well as a limitation of emissions from the device that may cause undesirable interference to other equipment. - Page 17 9.3. Guidance and manufacturer’s declaration – electromagnetic immunity – TABLE 204 The Optima pump is intended for use in the electromagnetic environment specified below. The user of the Optima pump should make sure it is used in such an environment. IEC 60601-1-2 Compliance level Immunity test...
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Page 18: Maintenance Recommendations
Please contact the appropriate service, responsible for cleaning and disinfecting products in your establishment for further details. Fresenius Kabi is not liable for loss or damage to the device during transport to our Technical Service. Recycling of obsolete batteries and devices : Before disposal, remove battery from the device. -
Page 19: Rs 232 Connection
When the device is disconnected from the main, it automatically switches Fresenius Kabi recommends the use of the RS232 lead ref. 200991. to battery mode without losing any programmed data. Otherwise, please use a lead whose length is 3 meters maximum. -
Page 20: Accessories
14. Accessories Fresenius Kabi recommends the use of Optima PT range accessories. Infusion Pump Rolling Stand - Bag/bottle holder – Cat # (Z)073025 Cat # (Z)073150 Designed for safe stable fixation of 1 to 3 infusion pumps . Bag/bottle holder... -
Page 21: Disposable
15. Disposable 15.1. Infudrop range In order to use the Optima PT pump in best conditions and cover most applications, we have developed sterile and single use disposables: the Infudrop series. All sets are designed and controlled by Fresenius Kabi in order to guarantee the performances and the safety features of our pump. -
Page 22: Conditions Of Guarantee
The serial number (ID/N°) must not have been altered, changed, or erased. In case of non-respect of these conditions, Fresenius Kabi will prepare an estimate for repair covering the parts and labor required. When return and repair of a device is necessary, please contact Fresenius Kabi Customer Service or Technical Service. - Page 23 Notes 1273-12_nu_optima_pt_eng_260516.doc - 23 -...
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Page 24: Useful Addresses
As standards and equipment change from time to time, the features shown and described in this document must be confirmed by our departments. This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Fresenius Vial - Le Grand Chemin - F-38590 BREZINS (FRANCE)
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