NGI-4515-6001, Revision F

Model 4515
NGI Gentle Rocker
A Dissolution Assistant for the Next
Generation Pharmaceutical Impactor

User’s Guide
August, 2014

Prepared by: MSP Corporation

5910 Rice Creek Parkway
Suite 300
Shoreview, MN 55126
651-287-8100
651-287-8140 (fax)
E-mail: [email protected]

M4515 User Guide

 NGI-4515-6001, Revision F

Document Approval

Title: User Guide Model 4515 NGI Gentle Rocker

Document No.: NGI-4515-6001, Revision F

Approved (original signatures on file):

Date:
Engineering

Date:
Product Management

Date:
Quality Assurance

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Change Log

Title: User Guide Model 4515 NGI Gentle Rocker

Document No.: NGI-4515-6001, Revision F

Revision Affected Description CAPA Release

Pages No. Date

D 10 Changed user notes to address the 1200 13-Jun-2011

splashing on cover during FAT
E 5 Updated applicable CE standards 1588 20-Jan-2014

6 Added altitude to specifications

F 6 Added max run time to specifications 1684 12-Aug-2014

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 NGI-4515-6001, Revision F

Introduction

The Gentle Rocker is a labor saving device designed to aid in the dissolution of deposited
particles from the impaction cups of the Next Generation Pharmaceutical Impactor (NGI).

Overview

This guide describes the components and the operation of The NGI Gentle Rocker. The
eleven sections of this manual include:

I. Safety
II. Specifications
III. Gentle Rocker Components
IV. Installation
V. Running the Gentle Rocker with Pre-Set Run Time
VI. Display Mode Functions
VII. Setup Mode Functions
VIII. Changing the Pre-Set Run Time
IX. A Programming Example
X. Maintenance and Technical Assistance
XI. User Notes

I. Safety

Summary: All safety related regulations, local codes and instructions that appear in
this literature or on equipment must be observed to ensure personal safety
and to prevent damage to either the instrument or equipment connected to
it. If the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.

Precautions: The user should not open the timer enclosure. The enclosure is labeled
with a high voltage decal.
The user should be cautious near the motor linkage. The motor linkage
area is marked with a pinch decal.
The instrument should be positioned so that the user can reach the on-off
switch on the back of the enclosure.
Care should be taken not to get the motor assembly or timer enclosure wet
either with solvent or with cleaning solution.
Gentle Rocker should be placed in a location that complies with the
ventilation requirements of the dissolution solvent.

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Declaration of Conformity – CE Mark

We, the producer: MSP Corporation

5910 Rice Creek Parkway, Suite 300
Shoreview, MN 55126
+001-651-287-8100
+001-651-287-8140 (Facsimile)

declare under our sole responsibility that the product,

Model 4515 Gentle Rocker

to which this documentation relates, is in conformity with the following Product

Specifications and Regulations:

Directives:
The Machinery Directive, 2006/42/EC
The Low Voltage Directive, 2006/95/EC
The CE Marking Directive, 93/68/EEC
The Electromagnetic Compatibility Directive, 2004/108/EC

Applicable Standards:

EN 61010-1:2010, Ed. 3, Safety Requirements for Electrical Equipment for

Measurement, Control, and Laboratory Use – Part 1 (General Requirements)

EN 61000-4-3 Issued: 2006+A1 2008+A2 2010

EN 61000-4-2 AMD 13187: 2001; IEC 61000-4-2: 1995

EN 61000-4-8 Issued: 1994 EN 61000-4-4 Issued: 1997

EN 61000-4-11 Issued: 2004 EN 61326-1 Issued: 2006

EN 61000-4-5 Issued: 2006

EN 50081-2, Generic Emission Standard – Part 2 (Industrial Environment)

EN 50082-2, Generic Immunity Standard – Part 2 (Industrial Environment)

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II. Specifications

Power: 220-240 VAC; 50 Hz -- Europe

110-120 VAC; 60 Hz – North America

Input Connections: IEC-320 female connector on one end and user’s country plug
on the other end.

European Union -- Rated 10 A @ 250 VAC

U.K. -- Rated 10 A @ 250 VAC, Right angle earthing plug

USA -- Rated 10A @ 125 VAC

Maximum Load: 0.2 A

Fuses: (1) F500mAH250V – UK and Ireland

(2) F500mAH250V – Rest of European Union

(2) F1AH250V – North America

Noise: < 50 dB

Temp: 0-50 °C

0-120 °F

Operating Humidity: 0-85 %, non-condensing

Weight: 9 kg

20 lb

Rotational Speed: 20 rpm or 40 rpm (see system label)

Maximum Run Time: 99,999.9 minutes

Altitude: 0-2,000 m

III. Gentle Rocker Components (Figure 1)

1. The Gentle Rocker Enclosure -- The Enclosure houses the timer and wiring. The
power switch, plug connection and fuse drawer are located on the back of the
enclosure.
2. The NGI Cup Tray and Impaction Cups -- The tray and cups are included with the
Next Generation Pharmaceutical Impactor (NGI).

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3. The Rocker Platform -- The cup tray and cover are set on the rocker platform.
Pins in the rocker platform provide tray location.
4. The Gentle Rocker Cover -- The cover is placed over the cup tray during
dissolution. The Pins in the rocker platform also provide location for the cover.
5. The Red Lion Timer -- Controls the motor by running for a user-specified period
of time.

4
2 1

Figure 1 – NGI Gentle Rocker – MSP Model 4515

IV. Unpacking and Installation

1. Remove packaging and plastic wrap from Gentle Rocker.

2. Remove plastic from Gentle Rocker cover.
3. Place Gentle Rocker on lab bench within 1m of outlet.
4. Plug female connector of power cable into connector on the back of the Gentle
Rocker enclosure.

V. Running the Gentle Rocker with Pre-Set Run Time

1. Plug the system’s power cord into the outlet.

2. Move the power switch on the back of the enclosure to the ON (“I”) position.
3. Place the NGI cup tray and impaction cups on the Gentle Rocker platform.
4. Place the cover over the tray.
5. Press “F1” to start the timer and motor.
The timer is set at the factory to run for 10 minutes. The following sections explain how
to change this value of 10 minutes to any other run time value.

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VI. Display Mode Functions (Display shows “TMR” and the timer value)

1. PAR: Enters the programming mode

2. F1: Starts the timer/motor

3. F2: Pauses the timer/motor

4. RST: Resets the timer to the last programmed value

VII. Setup Mode Functions (Display flashes “t Strt and the last programmed
time value”)

1. PAR: Accepts and records modified run time values, and skips the “CODE”
parameter returning the system to the display mode

2. F1: Increases the value of the selected (flashing) digit

3. F2: Decreases the value of the selected (flashing) digit

4. RST: Selects the next most significant

5. DSP: Exits programming mode and returns to display mode without storing any
programmed values

VIII. Changing the Pre-Set Run Time

1. Plug in the Gentle Rocker and turn on the power.

2. Press the “PAR” key to enter programming mode, display will flash (t Strt).

3. Set the run time (t Strt) as follows:

 F1: increases the value of the selected (flashing) digit

 F2: decreases the value of the selected (flashing) digit
 RST: selects the next most significant digit for editing
4. Once the desired time is set, press “PAR” to accept the run time.

5. Press “PAR” to bypass the CODE menu (value 000) and return to display mode.

6. Press “RST” to reset the timer to the programmed run time value.

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IX. A Programming Example

Below is an example of how to change the pre-set run time to 15 minutes.

1. Plug in Gentle Rocker and turn the unit on.

2. Press “PAR” to enter the programming mode, the display will flash “t Strt” and the
last programmed time setting in an alternating sequence.

3. Press “F2” until the tenths place reaches the zero digit.

4. Press “RST” to advance the flashing digit to the ones place.

5. Use the “F1” key to advance the ones place from 0 to 5.

6. Press “RST” to advance the flashing digit to the tens place.

7. Use the “F1” key to advance the tens place from 0 to 1.

8. Press “PAR” to enter the value.

9. Press “PAR” to bypass the CODE screen with the value flashing “000” this will
also exit the programming mode and return to the display mode.

10. Press “RST” to set the timer to the programmed value.

11. Press “F1” to start the timer/motor.

12. Press “F2” to pause the timer/motor, if desired.

13. Press “F1” to restart the timer/motor.

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X. Maintenance and Technical Assistance

For maintenance and technical assistance contact MSP Corporation directly.

Phone: 651-287-8100

Fax: 651-287-8140

Email: [email protected]

Address: MSP Corporation

5910 Rice Creek Parkway, Suite 300
Shoreview, MN 55126

Cleaning: The Gentle Rocker platform and base can be cleaned with
isopropyl alcohol on a lab tissue or with a damp, soapy sponge.
The electrical power shall be disconnected, and care should be
taken not to get the motor assembly or timer enclosure wet.

XI. User Notes

A liquid amount of 10-15 ml in the NGI small cups and 20-25 ml in the NGI large cups is
sufficient for good coverage of the cup surface and at the same time does not spill out of
the Gentle Rocker. If it is ever necessary to interrupt a normal run, this sudden stoppage
of the motion may cause the solution in the cups to gain sufficient momentum to come in
contact with the plastic cover. If the cover gets wetted, dry it before continuing.

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