SMALL VOLUME – 60 ML TECHNICAL CHART ELASTOMERIC PUMP IN SILICONE FOR CONTINOUS INFUSION

NOMINAL DATA: Filling volume : nominal 60 ml , maximum 65 ml , minimum 40 ml Available flow rates : 0,5 – 1,0 – 1,5 - 2,0 – 4,0 – 5,0 ml/hr Infusion duration : in function of the ratio: filling volume / flow rate Example: 48 ml of filling , 2,0 ml/hr flow rate, 24 hours duration Models : G0005X ; G0010X ; G0015X ; G0020X ; G0040X ; G0050X Fields of use : drugs in solution with continuous flow through venous access (periferal o central), epidural, subcutaneous, perineural, intrawound. DIAFUSER IS PRODUCED FOR DIACO S.p.A by: MANUFACTURER : CERTIFICATIONS :

CSM S.r.l. , via Mameli 38, Feletto Umberto Udine Tel 0432 – 575513 Fax 0432 – 687222 CE n° G1 10 08 63215 007 EN ISO 13485 :2003/AC:2007 – n° Q1N 10 08 63215 006

Quality control methods : CE regulations, annex 2 of the Directive 93/42CEE

WARNINGS ¾ ¾ ¾ ¾ ¾ ¾ ¾

STERILE PYROGEN-FREE MEDICAL DEVICE FOR SINGLE USE CLASS IIb STERILIZED BY ETO DO NOT USE IF THE POUCH IS DAMAGED DEVICES WAITING TO BE USED, HAV TO BE PROTECTED FROM DIRECT SUNLIGHT AND KEPT AT ROOM TEMPERATURE PACKAGING: IN SINGLE POUCHES, BOXES CONTAINING 10 UNITS BEFORE USING THE DEVICE READ THE INSTRUCTIONS CAREFULLY!

CSM – ver.02 – 05/05/2010

1

Non vented Blue cap

TECHNICAL SPECIFICATIONS Completely preassembled system, closed, unidirectional flow, biocompatible Accuracy : +/- 10% Positive pressure on exit : ca. 270 mmHg Filtrating system : anti particles filter of 1,2 micron , air venting of 0,02 micron Elastomeric balloon of silicone, transparent and Latex-Free Infusion line 90 cm long, anti kinking, of PVC-TOTM, DEHP-FREE Rigid external container crush resistant of polycarbonate transparent for visual inspection and indication of nominal device data (volume, flow rate and batch number) Anti UV protection: always guaranteeing the transparency, the filters used are offering protection against UV rays, up to the wave length of 380 ηm. Piston-guide system for optimal advancing of the infusion, provided with graded scale with numbers and a lens for an indicative verifying of the infusion advancement. Unidirectional filling port with luer lock, filter and anti-back valve Voluntary flow interruption system: removable clamp Luer lock distal connector, of ABS with flow rate indication and glass capillary inside Second distal cap of ABS coloured blue, for transport and indication of priming executed OPERATIONAL SPECIFICS Operational variables : viscosity of the solution, temperature , pressure System calibration : NaCl viscosity 0,9% , temperature 30-31° at the capillary, balloon and distal at the same level. Significant variations of the solution viscosity can cause variations to the infusion velocity in indirectly proportional way(The Quality control Lab is available, on request, to perform specific flow tests for particular drug solutions) Significant variations of the solution viscosity can cause variations to the infusion velocity in directly proportional way. Using the skin temperature of the patient as a stabilizer of the operational temperature, putting distal connector in direct contact with the skin. External variables of pressure through gravitational beat can cause variations of the infusion velocity in directly proportional way. Keep the balloon and distal connector approximately at the same level. Residue volume: < 3 ml, comprehensive of balloon, infusion line and distal connector. Initiate and terminate the filling using diluent (minimum 5 ml). CSM – ver.02 – 05/05/2010

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MEDIUM VOLUME – 100 ML - TECHNICAL CHART -

ELASTOMERIC PUMP IN SILICONE FOR CONTINOUS INFUSION

NOMINAL DATA: Filling volume : nominal 100 ml , maximum 105 ml , minimum 60 ml Available flow rates : 0,5 – 1,0 – 2,0 – 4,0 – 5,0 – 8,0 – 10,0 - 13,0 ml/hr Infusion duration : in function of ration volume of filling / flow rate Ex. 48 ml filling , 2,0 ml/hr flow rate, 24 hours duration Models : G0005M ; G0010M ; G0020M ; G0040M ; G0050M ; G0080M ; G0100M ; G0130M Fields of use : drugs in solution with continuous flow through venous access (periferal o central), epidural, subcutaneous, perineural, intrawound. DIAFUSER is produced for DIACO S.p.A, by: MANUFACTURER : CERTIFICATIONS :

CSM S.r.l. , via Mameli 38, Feletto Umberto Udine Tel 0432 – 575513 Fax 0432 - 687222 CE n° G1 10 08 63215 007 EN ISO 13485 :2003/AC:2007 – n° Q1N 10 08 63215 006

Procedure of Certification Annex II of Directive 2007/47/CE

WARNINGS ¾ ¾ ¾ ¾ ¾

STERILE PYROGEN-FREE MEDICAL DEVICE FOR SINGLE USE CLASS IIb STERILIZED BY ETO DO NOT USE IF THE POUCH IS DAMAGED DEVICES WAITING TO BE USED, HAV TO BE PROTECTED FROM DIRECT SUNLIGHT AND KEPT AT ROOM TEMPERATURE ¾ PACKAGING: IN SINGLE POUCHES, BOXES CONTAINING 10 UNITS ¾ BEFORE USING THE DEVICE READ THE INSTRUCTIONS CAREFULLY!

CSM – ver.0.2 – 05/05/2010

1

Non vented Blue cap

TECHNICAL SPECIFICATIONS Completely preassembled system, closed, unidirectional flow, biocompatible Accuracy : +/- 10% Positive pressure on exit : ca. 270 mmHg Filtrating system : anti particles filter of 1,2 micron , air venting of 0,02 micron Elastomeric balloon of silicone, transparent and Latex-Free Infusion line 90 cm long, anti kinking, of PVC-TOTM, DEHP-FREE Rigid external container crush resistant of polycarbonate transparent for visual inspection and indication of nominal device data (volume, flow rate and batch number) Anti UV protection: always guaranteeing the transparency, the filters used are offering protection against UV rays, up to the wave length of 380 ηm. Piston-guide system for optimal advancing of the infusion, provided with graded scale with numbers and a lens for indicative verifying of the infusion advancement. Unidirectional filling port with luer lock, filter and anti-back valve Voluntary flow interruption system: removable clamp Luer lock distal connector, of ABS with flow rate indication and glass capillary inside Second distal cap of ABS coloured blue, for transport and indication of priming executed OPERATIONAL SPECIFICS Operational variables : viscosity of the solution, temperature , pressure System calibration : NaCl viscosity 0,9% , temperature 30-31° at the capillary, balloon and distal at the same level. Significant variations of the solution viscosity can cause variations to the infusion velocity in indirectly proportional way(The Quality control Lab is available, on request, to perform specific flow tests for particular drug solutions) Significant variations of the solution viscosity can cause variations to the infusion velocity in directly proportional way. Using the skin temperature of the patient as a stabilizer of the operational temperature, putting distal connector in direct contact with the skin. External variables of pressure through gravitational beat can cause variations of the infusion velocity in directly proportional way. Keep the balloon and distal connector approximately at the same level. Residue volume: < 3 ml, comprehensive of balloon, infusion line and distal connector. Initiate and terminate the filling using diluent (minimum 5 ml). CSM – ver.0.2 – 05/05/2010

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LARGE VOLUME – 250 ML - TECHNICAL CHART -

ELASTOMERIC PUMP IN SILICONE FOR CONTINOUS INFUSION

NOMINAL DATA: Filling volume : nominal 250 ml , maximum 275 ml , minimum 140 ml Available flow rates : 1,0 – 1,5 - 2,0 –5,0 – 8,0 – 10,0 ml/hr Infusion duration : in function of ratio volume filled / flow rate Ex. 240 ml filling volume , 5,0 ml/hr flow rate, 48hours duraion Models : G0010D ; G0015D ; G0020D ; G0050D ; G0080D ; G0100D Fields of use : drugs in solution with continuous flow through venous access (periferical o central), epidurale, subcutaneous, perineural, intrawound. DIAFUSER is produced for DIACO S.p.A, by: MANUFACTURER :

CSM S.r.l. , via Mameli 38, Feletto Umberto Udine Tel 0432 – 575513 Fax 0432 - 687222 CERTIFICATIONS : CE n° G1 10 08 63215 007 EN ISO 13485 :2003/AC:2007 – n° Q1N 10 08 63215 006 Quality control methods : CE regulations, annex 2 of the Directive 93/42CEE WARNINGS ¾ ¾ ¾ ¾ ¾ ¾ ¾

STERILE PYROGEN-FREE MEDICAL DEVICE FOR SINGLE USE CLASS IIb STERILIZED BY ETO DO NOT USE IF THE POUCH IS DAMAGED DEVICES WAITING TO BE USED, HAV TO BE PROTECTED FROM DIRECT SUNLIGHT AND KEPT AT ROOM TEMPERATURE PACKAGING: IN SINGLE POUCHES, BOXES CONTAINING 10 UNITSI BEFORE USING THE DEVICE READ THE INSTRUCTIONS CAREFULLY!

CSM – ver.0.2 – 05/05/2010

1

TECHNICAL SPECIFICATIONS Completely preassembled system, closed, unidirectional flow, biocompatible Accuracy : +/- 10% Positive pressure on exit : ca. 270 mmHg Filtrating system : anti particles filter of 1,2 micron , air venting of 0,02 micron Elastomeric balloon of silicone, transparent and Latex-Free Infusion line 90 cm long, anti kinking, of PVC-TOTM, DEHP-FREE Rigid external container crush resistant of PET transparent for visual inspection and indication of nominal device data (volume, flow rate and batch number) Piston-guide system for optimal advancing of the infusion, provided with graded scale with numbers and a lens for an indicative verifying of the infusion advancement. Unidirectional filling port with luer lock, filter and anti-back valve Voluntary flow interruption system: removable clamp Luer lock distal connector, of ABS with flow rate indication and glass capillary inside Second distal cap of ABS coloured blue, for transport and indication of priming executed OPERATIONAL SPECIFICS Operational variables : viscosity of the solution, temperature , pressure System calibration : NaCl viscosity 0,9% , temperature 30-31° at the capillary, balloon and distal at the same level. Significant variations of the solution viscosity can cause variations to the infusion velocity in indirectly proportional way(The Quality control Lab is available, on request, to perform specific flow tests for particular drug solutions) Significant variations of the solution viscosity can cause variations to the infusion velocity in directly proportional way. Using the skin temperature of the patient as a stabilizer of the operational temperature, putting distal connector in direct contact with the skin. External variables of pressure through gravitational beat can cause variations of the infusion velocity in directly proportional way. Keep the balloon and distal connector approximately at the same level. Residue volume: < 3 ml, comprehensive of balloon, infusion line and distal connector. Initiate and terminate the filling using diluent (minimum 5 ml). CSM – ver.0.2 – 05/05/2010

2

ONLY BOLUS - TECHNICAL CHART -

SILICONE ELASTOMERIC PUMP FOR DRUG INFUSION ON DEMAND

DATI NOMINALI Filling volume: Preset bolus :

nominal 60 ml (max 65 ml, min 40 ml) nominal 100 ml (max 105, min 60 ml) 0,5 – 1,0 - 2,0 ml

Bolus available every:

6 – 8 – 15 - 60 min.

Duration of the infusion: depending on ration of filling volume / number of boluses applied Models : JB0506X, JB1006X, JB2006X, JB0508X, JB1008X, JB2008X, JB0510X, JB1010X, JB2010X, JB0515X, JB1015X, JB2015X, JB0506M, JB1006M, JB2006M, JB0508M, JB1008M, JB2008M, JB0510M, JB1010M, JB2010M, JB0515M, JB1015M, JB2015M. (PLEASE SEE CATALOGUE FOR SPECIFICS OF EVERY MODEL) Destinazione d’uso : infusion of drugs in solution by bolus on demand, through venous access (periferica or central), epidural, subcutaneous, perineural, intrawound. DIAFUSER is produced for DIACO S.p.a, by: MANUFACTURER : CERTIFICATIONS :

CSM S.r.l. , via Mameli 38, Feletto Umberto Udine Tel 0432 – 575513 Fax 0432 - 687222 CE n° G1 10 08 63215 007 EN ISO 13485 :2003/AC:2007 – n° Q1N 10 08 63215 006

Quality control methods : CE regulations annex 2 to the Directive 93/42CEE WARNINGS ¾ ¾ ¾ ¾ ¾ ¾ ¾

STERILE PYROGEN-FREE MEDICAL DEVICE FOR SINGLE USE CLASS IIb STERILIZED BY ETO DO NOT USE IF THE POUCH IS DAMAGED DEVICES WAITING TO BE USED, HAV TO BE PROTECTED FROM DIRECT SUNLIGHT AND KEPT AT ROOM TEMPERATURE PACKAGING: IN SINGLE POUCHES, BOXES CONTAINING 10 UNITS BEFORE USING THE DEVICE READ THE INSTRUCTIONS CAREFULLY!

CSM – ver.02 – 05/05/2010

1

TECHNICAL SPECIFICATIONS Completely preassembled system, closed, unidirectional flow, biocompatible Accuracy : +/- 10% Positive pressure on exit : ca. 270 mmHg Filtrating system : anti particles filter of 1,2 micron , air venting of 0,02 micron Elastomeric balloon of silicone, transparent and Latex-Free Infusion line 90 cm long, anti kinking, of PVC-TOTM, DEHP-FREE Rigid external container crush resistant of polycarbonate transparent for visual inspection and indication of nominal device data (volume, flow rate and batch number) Anti UV protection: always guaranteeing the transparency, the filters used are offering protection against UV rays, up to the wave length of 380 ηm. Piston-guide system for optimal advancing of the infusion, provided with graded scale with numbers and a lens for indicative verifying of the infusion advancement. Unidirectional filling port with luer lock, filter and anti-back valve Voluntary flow interruption system: removable clamp Luer lock distal connector, of ABS with flow rate indication and glass capillary inside Second distal cap of ABS coloured blue, for transport and indication of priming executed PCA module of ABS OPERATIONAL SPECIFICS Operational variables : viscosity of the solution, temperature , pressure System calibration : NaCl viscosity 0,9% , temperature 30-31° at the capillary, balloon and distal at the same level. Significant variations of the solution viscosity can cause variations to the infusion velocity in indirectly proportional way(The Quality control Lab is available, on request, to perform specific flow tests for particular drug solutions) Significant variations of the solution viscosity can cause variations to the infusion velocity in directly proportional way. Using the skin temperature of the patient as a stabilizer of the operational temperature, putting PCA module in direct contact with the skin. External variables of pressure through gravitational beat can cause variations of the infusion velocity in directly proportional way. Keep the balloon and PCA module approximately at the same level. Residue volume: < 3 ml, comprehensive of balloon, infusion line, bolus reservoir and distal connector. Initiate and terminate the filling using diluent (minimum 5 ml) CSM – ver.02 – 05/05/2010 2