HD 380 Valipak

SAFETY GUARANTEED: VALIDATION OF HEAT SEALING PROCESSES.
The safety of doctor and patient is at the forefront of all considerations. Primary objective of packing critical medical devices (instruments which penetrate the skin or mucous membrane and thus come into contact with blood, internal tissues or organs, including wounds) in medical and dental practices is the maintenance of sterility until the point of use.
The international standards ISO 11607-2 and ANSI/AAMI/ISO 11607-2 therefore explicitly call for validated processes for packing medical devices.
Sealing devices must meet the following validation requirements:
> monitoring of critical process parameters and
> warn the user in case of deviation from preset values
As the first heat sealer in its class the ValiPak® meets these requirements.
Three high-tech sensors monitor the critical process parameters
(temperature, sealing time and sealing pressure) during the
sealing process. If one of the parameters deviates, the user is notified acoustically and visibly via the display. Furthermore, the device has a PC interface (for process and batch documentation systems). Another safety feature is the extra wide seal seam width.
Valipak Heat Sealer
RANGE OF USE AND CERTIFICATIONS
Especially suitable for use in Medical and dental practices
CE sign x
Conformity ISO 11607-2 and ANSI/AAMI/ISO 11607-2 x
Calibration certificate x
GreenTek® x

POWER SUPPLY AND MECHANICAL DATA
Mains connection and frequency | Power 1 115V, 50/60 Hz / 230 V, 50/60 Hz | 100 Watt
Dimensions w x d x h | Weight 420 x 360 x 220 mm (16.5 x 14 x 8.7 in) | 6,6 kg (13 lb)
Casing cover Stainless steel AISI 304
Sealing system permanently heated
Seal seam width / length 10 mm (0.4 in) / max. 250 mm (9.8 in)
Heating-up time Approx. 120 sec


SEALING MATERIALS
Sealable paper pouches (e. g. EN 868-4:2009) x
Sealable pouches and reels (e. g. EN 868-5:2009) x


ELECTRONIC FEATURES AND COMMUNICATION
Control Microprocessor
Autosafe (Parameter settings remain even after a power failure) x
Display and data input 7 segment with single keys
PC interface (for integration into process documentation systems and practice software) x
Stand-by (automatic shut-off after 30 minutes) x
Piece counter x


CONTROL FUNCTIONS IN ACCORDANCE WITH EN ISO 11607-2 and ANSI/AAMI/ISO 11607-2
Validatable process x
Seal Check function for routine documentation x
Process parameters monitored (with alert function in case of deviations):
Sealing temperature x (max. 200 °C/392 °F adjustable)
Sealing time x (fix)
Sealing pressure x (fix)
1 Value can vary during heating-up period.
hd 380 WSI-V ValiPak®

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