User Guide
54 Pages
Preview
Page 1
USER GUIDE
Canè S.p.a. Medical Technology Via Cuorgnè 42/a 10098 Rivoli (TO) Italy Tel.+39 011 9574872 - Fax +39 011 9598880 www.canespa.it - [email protected]
MAN 01/00 CRONO F 07/11
TablE OF COnTEnTS
Introduction... page 5 Note... page 6 Intended use... page 6 Information - technical assistance... page 6 Desctription of the pump... page 7 Technical features... page 7 Factory settings... page 9 Standard equipment supplied... page 10 Optional accessories... page 11 How to use the standard equipment supplied... page 12 How to wear the pump... page 13 Pump overview... page 14 Liquid crystal display (LCD)... page 15 Main screen indication... page 16 Key-pad... page 18 Syringes... page 19 Luer lock cap... page 19 Filter... page 19 Infusion set... page 19 Preparation for infusion... page 19 Syringe preparation... page 20 Connection of the syringe to the pump... page 20 Safety system to avoid free-flow... page 21 Device activation... page 22 Key pad lock out... page 22 Table of key-pad lock-out levels... page 24 Programming... page 25 Programming the syringe size... page 26 Programming of F-bolus dose volume... page 27 Interval time between F-bolus doses... page 28 Programming of partial volume... page 29 Starting the pump... page 31 Priming... page 31 Pump in on (running)... page 33 F-bolus dose... page 33 3
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Infusion set occlusion... page 34 End of infusion... page 34 Reversals of the pump pusher... page 35 Pump pusher movement... page 36 Switching off the pump... page 37 Displaying programmed parameters... page 37 Displaying delivered volumes... page 38 Displaying the number of complete infusions... page 39 Low battery alert... page 39 Battery replacement... page 40 General cautions... page 42 Maintenance... page 42 Cleaning... page 42 Storage... page 43 Pump life... page 43 Disposal of the pump... page 43 User information... page 44 Manufacturer's guarantee... page 45 Alarm message... page 47 Short instructions... page 48 Pump icon table... page 52 Syringe blister package icon table... page 53 Glossary... page 54
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InTRODUCTIOn Caution: U.S. Federal law restricts this device for sale by or on order of a physician. The instructions provided in this manual are intended for both the prescribing physician, and for patients who subsequently use the Crono F pump. The pump is ready to use at delivery and does not require installation or other tests before being used on patients.
WaRnInGS Before starting operating the pump, it is necessary to have a thorough knowledge of the pump's technical features and functions. The entire manual should be read before the pump is used on patients and always be kept together with the pump for references. Failure to properly follow instructions and warnings contained in the user guide could cause injury to the patient. If you know or suspect that the pump has been damaged in any way, for example through water or impact, please contact your local Customer Service representative to verify if the pump is operational. The pump is not waterproof. Liquid on the outside of the pump should be wiped off immediately with a soft cloth. Please observe that any liquid penetrating the pump can cause serious damage to the pumps' electronic circuits. Do not use a pump that is damaged or not working properly.
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nOTE The manufacturer only takes the responsibility for the safety and reliability of this pump, provided that it is used in accordance with the current instructions for use and only in case any repairs and changes to the device are made exclusively by the manufacturer.
InTEnDED USE Crono F is an ambulatory drug delivery pump designed to deliver subcutaneous and intravenous pulsatile infusion.
InFORMaTIOn – TECHnICal aSSISTanCE For further information, technical assistance or if you have questions concerning the operation of the pump, please contact: UnITED STaTES: InTRa PUMP InFUSIOn SYSTEMS 920 Minters Chapel Road, Suite 200 Grapevine, Texas 76051 Tel: 866-211-7867 Fax: 630-845-2768 Email: [email protected] ManUFaCTURER: Canè S.p.a. MEDICal TECHnOlOGY Via Cuorgnè, 42/a 10098 Rivoli (TORINO) Italy Tel: +39-011-9574872 Fax: +39-011-9598880 Email: [email protected]
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DESCRIPTIOn OF THE PUMP Crono F is a new innovative pulsatile ambulatory infusion pump for controlled drug administration on patients in hospital or in ambulatory care. The pump is provided with key-pad lock-out functions in order to avoid unauthorized reprogramming of the drug administration protocol. The liquid crystal display (LCD) shows the information which are helpful both for the clinician and the patient like programming, remaining delivery time and remaining time to the next pulse of prescribed drug.
TECHnICal FEaTURES Pump size
77 x 47 x 29 mm.
Weight
115 g (battery included).
Battery
CR 123A 3V Lithium battery (battery life: at least 3 months).
Syringe
Dedicated syringes 10 and 20 ml.
Administration volumes
From 1 ml to 20 ml with steps of 1 ml.
Priming
Available only at the beginning of an infusion or partial infusion. The maximum deliverable volume is 3.0 ml with 0.5 ml increments.
F-bolus dose
Automatic bolus dose is available in two volumes: 25 or 50 µl. F-bolus duration is 1 minute for both dose. 7
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Interval time between F-boluses F-bolus pump mean accuracy
Programmable from 5 minutes to 300 minutes in steps of 5 minutes. +/- 1%.
F-bolus system: • mean accuracy • maximum positive deviation • maximum negative deviation
+/- 5%. + 13.9%. - 18.1%.
Max. occlusion pressure
4.0 bar +/-1.
Data storage
The selected data are automatically stored in the pump memory and they are not lost when the battery is removed.
Motor
DC coreless motor microprocessor controlled, equipped with optical encoder.
Safety circuits
To monitor the correct working of the device intervening in case of anomalies with acoustic warnings and error messages.
Anti free-flow system
To avoid a non controlled flow inside the delivery set due to the action of the force of gravity.
Operating conditions
+10°C / +45 °C 30% / 75% RH 700 hPa / 1060 hPa
Storage conditions
-10°C / +60 °C 10% / 100% RH 500 hPa / 1060 hPa 8
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FaCTORY SETTInGS The following pump:
factory settings are programmed at the delivery of the
Key-pad lock-out level
L0
Syringe size
10 ml
F-bolus
25 µl
F-bolus interval time
90 minutes
Number of infusions
0
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STanDaRD EqUIPMEnT SUPPlIED 1. Ambulatory infusion pump. 2. Pump case. 3. Elastic belt. 4. Collar strap. 5. Fabric holder. 6. 2 batteries (one already inserted in the pump). 7. Battery compartment opening tool. 8. User guide.
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OPTIOnal aCCESSORIES Optional accessories are available upon request: 1. Upright leather holder similar to a mobile telephone holder. 2. Horizontal leather holder similar to a sunglasses case.
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HOW TO USE THE STanDaRD EqUIPMEnT SUPPlIED The following illustrations show how the pump and its accessories can be set up.
10
20ml
How to attach collar strap to the pump and the fabric holder. How to use elastic belt with pump and fabric holder
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HOW TO WEaR THE PUMP The following pictures show the various ways the pump can be worn. Wearing the pump around the neck Wearing the pump around the neck with a collar strap and a fabric holder.
Wearing the pump at the waist Wearing the pump at the waist with an elastic belt and a fabric holder.
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PUMP OVERVIEW Collar strap locking rings Syringe fin hook Display Buttons
Pusher Battery compartment
Serial number Short instructions
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lIqUID CRYSTal DISPlaY (lCD) This is a screen on the front of the pump where symbols and messages are displayed informing the user about operations in progress as well as giving warnings and alarm messages. “Low battery” symbol: appears when the battery charge is low (see page 40). “Drip” symbol: separates whole numbers from decimals.
10 20
10 20
10 20
’
“ ” symbol:
10
indicates minutes.
20
“10” symbol: indicates the device has been programmed to use 10 ml (CRN 10) syringe setting.
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“20” symbol: indicates the device has been programmed to use 20 ml (CRN 20) syringe setting.
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MaIn SCREEn InDICaTIOn The above screens are given as examples of what can be displayed. 10 02 10 20
Pump OFF Prime function
10
Prime execution
02 10
Time left to the end of infusion (hour)
02 10 02
Time left to the end of infusion (days)
10
Time left to the next F-bolus
02 10
F-bolus
02 10 02
Ongoing F-bolus delivery
10
Time interval between F-boluses
02 10 02 10 02
Partial volume Pump unlocked 16
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10
Pump locked
02 10
Number of delivered infusions
20 10
Error message (see page 47)
20 10
Occlusion
20
10
Feed/reversal motion of the pump pusher
20 10
End of infusion
02 10
Low battery
20 10
Battery discharged
02
Volume delivered (ml) as F-bolus doses
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10 02
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KEY-PaD • The key-pad has 3 buttons for programming and the operation of the pump. • The buttons are time-controlled: keep buttons pressed for a few seconds to activate commands. • Command execution is confirmed by a brief acoustic signal. • During the selection of the parameters the button is used to decrease the value displayed on the screen, the button to increase the value.
CaUTIOn Press the buttons with your finger-tips only, do not use sharp or pointed objects.
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YES
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SYRInGES
Plunger
The ambulatory infusion pump Crono F uses dedicated 10 and 20 ml dedicated syringes. The 10 and 20 ml syringes are: • sterile; • single use only; • pyrogen-free; • to be used only if packaging is not damaged.
lUER lOCK CaP
The luer lock cap should be used to protect a filled syringe from contamination if the syringe isn't used immediately after filling and makes it easier to connect the syringe to the pump pusher by creating a backpressure.
10
20ml
Plunger Rod
Syringe structure
Needle
FIlTER
It is possible to use bacterial and air filter if it is deemed as a necessary precaution.
Needle’s cap
Luer-lock cap
InFUSIOn SET
For information about infusion sets, please see the instruction supplied with the products.
10
20ml
PREPaRaTIOn FOR InFUSIOn
Before the pump and other disposables are prepared to be used, make sure that you take the following precautions to avoid any contamination: 1. Wash your hands; 2. Prepare a clean working area.
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SYRInGE PREPaRaTIOn 1. Attach the supplied needle to the syringe with a clockwise rotation. 2. Draw up the infusion solution slowly. Do not exceed the syringe capacity. 3. Attach luer-lock cap and unscrew the stem of the syringe counter-clock wise with a fairly swift movement. 4. Attach the syringe to the pump as shown in picture 4 and in the “connection of the syringe to the pump”. If it is necessary to use a partial volume this has to be set before connecting the syringe on the pump. 5. Attach the infusion line onto the syringe.
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10 10
10
20 ml
20 ml
20 ml
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10
20 ml
20 ml
COnnECTIOn OF THE SYRInGE TO THE PUMP
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