Important notice
Our calibration may not meet all calibration requirements for critical packaging machines, be sure
to evaluate our calibration process by contacting our engineering group at 800-550-3854. Your
machine’s calibration status is a matter of record when leaving our laboratory, the data-logging
session represents the “as left” condition of your sealer at the time of calibration. It is possible
that a mechanical/physical change, i.e. shipping damage, could change your calibration, therefore,
we recommend evaluating your machine’s thermal performance when your sealer returns in order
to thwart possible seal failures.
Please contact our engineering group for guidance on appropriate protocols and testing equipment to
perform a calibration check at 800- 550-3854. Calibration can be altered if certain parts are
changed on the sealer, it is recommended that you always check the thermal performance after service
or repair of your sealer. Some of the sealers we calibrate have a wide +/- thermal performance
range, therefore when developing your packaging validation you should allow for that range in order
to understand the sealers’ possible range of performance after calibration. Because many
factors can affect the adherence to the calibration range we always recommend checking calibration
throughout the year.
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, technician’s 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 assess the value of the “type” of calibration selected to the regulatory process
that our customers are bound to.
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,
technician’s 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 assess the value of the “type” of calibration selected for
the regulatory process that our customers are bound to.
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 technician’s 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 assess the value of the
“type” of calibration selected for the regulatory process that our customers are bound to.
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 technician’s 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 assess the value of the “type” of calibration selected for the regulatory process
that our customers are bound to.
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 technician’s 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 assess the value of the “type” of calibration selected for the regulatory process
that our customers are bound to.
Accredited Calibration
We provide ISO/IEC 17025 accredited calibration services for customers that request this level of
service. By requesting ISO/IEC 17025 accredited calibration services, you agree to the following
conditions:
- Calibrations will be performed to manufacturer’s specifications using manufacturer’s procedures,
- Calibration intervals will be established to manufacturer’s recommended service intervals
(unless you request otherwise),
- Statements of conformity (e.g. Pass, Fail, In Tolerance, or Out of Tolerance) will be made in
accordance with the following decision rules:
- Pass means the measurement result is within the manufacturer’s specifications (without
taking into account the measurement uncertainty); and
- Fail means the measurement result exceeds the manufacturer’s specifications (without taking
into account the measurement uncertainty).
- Measurement results found to be out of tolerance will be adjusted (where possible).
If you have questions regarding the scope of this calibration please contact customer
service. 800-550-3854
Important information regarding shipping your sealer
Before returning your packaging equipment for service or calibration, please read the following SRA
(Service Return Authorization): Third-party shipping organizations such as UPS and Federal Express
are accustomed to moving a variety of packages, but oftentimes they disregard fragile labels. The
typical handling with these types of carriers is very rough. Within our own shipping department, we
have a dock height drop arbiter to determine how well a machine is packed. In other words, if your
product were dropped at the height of a commercial truck dock, it should survive the fall unscathed.
In order to achieve this robust packaging, you should not use fillers such as loose-filled
Styrofoam, as it allows too much movement within the container during the shipping process.
When preparing your sealing equipment for shipment, you should first secure the sealing jaws by
carefully placing a foam rubber or corrugated insert in the jaws in order to prevent the jaws from
moving during shipment, which can cause a sealing jaw breakage. After securing the jaw, the sealing
equipment should be placed in an oversized plastic bag in order to prevent packaging material and
particulates from entering the inside of the machine during the shipping process. The bagged machine
should be placed in a heavy, preferably double walled, corrugated box with a minimum of six inches
of buffer space between the machine and the box walls. This includes the bottom of the box as well.
A foam sheet should be placed on the bottom of the box. The sealing machine should be placed in the
center and all sides surrounding the machine should also be buffered with multiple layers of
corrugated or foam material. Pay special attention to the jaw ends where the electrodes are located.
This process should be repeated at the top of the machine. There should be no air space on any of
the sides within the box, so the machine cannot move during shipment.
Also, if you are sending any loose parts with the machine, such as cables, etc. do not place them
near the machine as they may rub during shipment causing damage. Do not send the machine table (that
the pouch rests on when sealing) as this may rub against the machine and cause damage. If you have
any specific requests in terms of how the machine should be calibrated or serviced, or a description
of the problems the machine is experiencing, those should be included with the documentation. Also,
prominently note any safety concerns or specific hazardous conditions of the sealer under the
Additional Comments section of the SRA Number Request Form.
A Maintenance Supervisor’s name and phone number should be included. The machine should be strapped
with fiber strapping tape or nylon shipping straps and marked excessively with red fragile labels on
every exposed panel of the shipping container. Further, the SRA (Service Return Authorization)
number should be prominently marked on the face of the box. Also, it has been our experience even
when utilizing extreme caution, machine damage can still occur. Therefore, it is vital that you send
the equipment insured for the purchase amount of the unit in order to secure your investment. Van
der Stahl Scientific Inc. cannot be responsible for any equipment in transit to our facility for
service and repair. Please sign this agreement acknowledging that you understand how the equipment
should be prepared for safe transit and fax it back to our customer service line at 866-203-0809.
Should you have additional questions regarding this service return authorization, please feel free
to contact our customer service agents at 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 the 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 the 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. Customers may not return products without first obtaining a customer service return
authorization (SRA) number from VDS. If VDS elects to repair the affected product, all warranty work
performed on our products will be handled by a VDS Service Technician at the VDS service center in
southern California and the amount of time it may take on a service will depend on technician
availability due to service load. VDS will repair or replace the machine with new or reconditioned
parts.
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, AND ANY WARRANTY THAT MAY ARISE FROM COURSE
OF DEALING, COURSE OF PERFORMANCE, OR USAGE OF TRADE. IF VDS CANNOT LAWFULLY DISCLAIM IMPLIED
WARRANTIES UNDER THIS LIMITED PRODUCT WARRANTY, ALL SUCH IMPLIED WARRANTIES, INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE WARRANTY PERIOD
(AS DEFINED ABOVE). YOUR SOLE REMEDY WITH RESPECT TO ANY BREACH OF THE LIMITED PRODUCT WARRANTY
SHALL BE THE REPAIR OR REPLACEMENT OF THE DEVICE AS SPECIFIED IN THE LIMITED PRODUCT WARRANTY. VDS
IS NOT RESPONSIBLE FOR DIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY
BREACH OF WARRANTY OR UNDER ANY OTHER LEGAL THEORY INCLUDING, BUT NOT LIMITED TO, LOST PROFITS,
DOWNTIME, GOODWILL, DAMAGE TO, OR REPLACEMENT OF EQUIPMENT AND PROPERTY, AND ANY COSTS OF
RECOVERING, REPROGRAMMING, OR REPRODUCING ANY PROGRAM OR DATA STORED IN OR USED WITH A SYSTEM. THIS
LIMITED WARRANTY SHALL NOT EXTEND TO ANYONE OTHER THAN THE ORIGINAL PURCHASER OF IS PRODUCT, IS
NONTRANSFERABLE, AND STATES YOUR EXCLUSIVE REMEDY.
Some states do not allow the exclusion or limitation of incidental or consequential damages or
exclusions or limitations on the duration of implied warranties or conditions, so the above
limitations or exclusions may not apply to you. This limited warranty gives you specific legal
rights, and you may also have other legal rights, which vary from state to state. VDS makes no
claims that our medical device packaging equipment meets the requirements of all medical device
manufacturers’ validations. Medical device packaging validation varies greatly depending on the risk
policy of the medical device manufacturer as well as the class of medical device. It’s important
that our customers understand all of our packaging machine functionality in terms of accuracy of the
sealer, machine alarms, as well as other negative machines, attributes that might affect your
medical device packaging validation. 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 m maintenance. VDS does not perform validations for our customers as it is
beyond the scope of our function as a machine provider. The process of medical device packaging
validation is complicated and should be performed by quality or manufacturing engineers that
understand the installation qualification process before purchasing packaging equipment.