Important Notice
Van der Stahl Scientific, Inc. takes great care in servicing and calibrating your equipment. To be
certain all sealers are functioning as expected when performing an onsite service/calibration we will
strictly adhere to our Onsite Calibration Protocol. In order to help thwart mechanical issues that may
affect calibration accuracy, a machine inspection will be included with most machines prior to
calibration. However, we are performing these inspections in only a small fraction of the equipment’s
operation life. Therefore, return visits to the facility that we perform the onsite service or
calibrations at is not included as part of our service warranty. It is important that someone at your
facility inspect the equipment before the service technician leaves your facility, as again the return
visit is not covered under the service warranty. We suggest you run a peel study on your pouch and
evaluate that the unit is performing as expected before the technician leaves your facility.
To ensure that the technician can perform the service/calibration as efficiently as possible you must
provide sufficient space for the equipment and all calibration equipment to be set up. You must also
provide sufficient access to power outlets for the equipment and calibration equipment. Our Onsite
Calibration Protocol states, “If the location does not allow for the requirements of the Quality Manual,
the requirements of the method, and the requirements of the customer to be met then the activity shall
be postponed or moved to a different area that is suitable.” In the event that the onsite activity must
be postponed the rescheduling and reimbursement of any travel fees shall be the responsibility of the
customer. An IN TOLERANCE (PASS) or OUT OF TOLERANCE (FAIL) conclusion is based upon simple acceptance
as defined in ILAC-G8:09/2019 section 4.2.1. Should you have additional questions regarding our onsite
calibration and service please feel free to contact customer service at 800-550-3854
Basic Calibration
Temperature sampled at a single location on the platen at a single set point. A redundant data
logging session is performed with a different meter and test lead to verify test accuracy. This
includes a certificate, machine affixed sticker with record number, technicians name, and
calibration due date. The line item data, as well as waveform data, is also included with this
calibration package. It is the customer’s responsibility to understand the appropriate calibration
needed. We do not asses the value of the “type” of calibration selected to the regulatory process
that our customers are bound.
Basic Plus Calibration
Temperature sampled at a single location on the platen at a single set point. A redundant data
logging session is performed with a different meter and test lead to verify test accuracy. If your
machine qualifies, we will also perform a mechanical calibration for force and verification of the
timer function. This includes a certificate, machine affixed sticker with record number, technicians
name, and calibration due date. The line item data, as well as waveform data, is also included with
this calibration package. It is the customer’s responsibility to understand the appropriate
calibration needed. We do not asses the value of the “type” of calibration selected to the
regulatory process that our customers are bound.
Pro Calibration
Temperature sampled at a single location on the platen at multiple set points (up to 3 temperatures),
i.e. 220-275-350. A redundant data logging session is performed with a different meter and test lead
to verify test accuracy. This includes a certificate, machine affixed sticker with record number,
and technicians name, and calibration due date. The line item data, as well as waveform data, is
also included with this calibration package. It is the customer’s responsibility to understand the
appropriate calibration needed. We do not asses the value of the “type” of calibration selected to
the regulatory process that our customers are bound.
Pro Plus Calibration
Temperature sampled at a single location on the platen at multiple set points (up to 3 temperatures),
i.e. 220-275-350. A redundant data logging session is performed with a different meter and test lead
to verify test accuracy. If your machine qualifies, we will also perform a mechanical calibration
for force and verification of the timer function. This includes a certificate, machine affixed
sticker with record number, and technicians name, and calibration due date. The line item data, as
well as waveform data, is also included with this calibration package. It is the customer’s
responsibility to understand the appropriate calibration needed. We do not asses the value of the
“type” of calibration selected to the regulatory process that our customers are bound.
Pro Plus Complete
Temperature sampled at a single location on the platen at multiple set points (up to 3 temperatures),
i.e. 220-275-350. A redundant data logging session is performed with a different meter and test lead
to verify test accuracy. If your machine qualifies, we will also perform a mechanical calibration
for force and verification of the timer function. This includes a certificate, machine affixed
sticker with record number, and technicians name, and calibration due date. The line item data, as
well as waveform data, is also included with this calibration package. In addition, we will perform
an accredited ASTM F88 peel study on thirty samples of your pouch material as well as an accredited
ASTM F1929 dye penetration test on material that qualifies. It is the customer’s responsibility to
understand the appropriate calibration needed. We do not asses the value of the “type” of
calibration selected to the regulatory process that our customers are bound.
If you have questions regarding the scope of this calibration please contact customer service.
800-550-3854
LIMITED SERVICE WARRANTY TO ORIGINAL PURCHASER
This limited service warranty applies solely to equipment serviced or repaired by Van der Stahl
Scientific, Inc. (VDS), and does not include transportation, installation, or removal or
re-installation. Subject to the limitations herein, VDS warrants that the service or repair of new
machinery for one (1) year from date of purchase, will be free from defects in new materials and
workmanship.
This limited service warranty excludes: (a) damage which occurs in shipment; (b) applications and uses
for which machine was not intended; (c) failures or problems which are caused by products or equipment
not supplied by VDS; (d) accidents, misuse, abuse, neglect, misapplication, fire, water, lightning or
other acts of nature; (e) incorrect electrical line voltage, fluctuations or surges; (f) damage caused
by improper or faulty installation, or any act, error, neglect or default of Customer; (g) improper
connection with any peripheral; (h) machine alteration or modification; (i) in1proper or unauthorized
repair; (j) cosmetic damage to exterior finish; (k) machines with altered serial numbers; (I) failure to
follow operating instructions as covered in the manual, including maintenance and calibration
guidelines; (m) normal wear to parts such as heating elements, glass cloth, silicone rubber, temperature
sensors, shock absorbers; (n) customer adjustments, maintenance and environmental instructions which are
covered and prescribed in the product manual. All warranty work will be performed at VDS facility.
If such VDS product fails to conform to the warranty above, the exclusive remedy of Customer and the sole
liability of VDS shall be, at the option of VDS, to replace or repair the affected product, or to refund
to Customer the price of the affected products. The availability of replacement products is subject to
product discontinuance policies at VDS. Customer may not return products without first obtaining a
customer service return authorization (SRA) number from VDS.
THE WARRANTIES SET
FORTH HEREIN ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, REMEDIES AND CONDITIONS, WHETHER ORAL OR
WRITTEN, EXPRESS OR IMPLIED. VDS DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY,
INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT...
Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above
limitations or exclusions may not apply to you. VDS makes no claims that our medical device packaging
equipment meets the requirements of all medical device manufacturers’ validations. It is the customer’s
responsibility to maintain the equipment in order for the machine to develop expected performance. Due
to the wide range of packaging materials and throughput, it is impossible to develop a generic
recommended preventative maintenance plan. It is the customer’s responsibility to develop a preventative
maintenance plan based on machine settings and throughput. It is the customer’s responsibility to
calibrate the machinery, our firm does not send out reminders or notifications regarding calibration
maintenance. VDS does not perform validations for our customers as it is beyond the scope of our
function as machine provider.
